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Patent Law

Law 677 | Spring 2003

Professor Wagner

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HeinOnline --- 53 Vand. L. Rev. 1727 (2000)

3 of 3 DOCUMENTS

ENZO BIOCHEM, INC., Plaintiff--Appellant, v. GEN--PROBE INCORPORATED, andCHUGAI PHARMA U.S.A., INC. and CHUGAI PHARMACEUTICAL CO., LTD., and

BIOMERIEUX, INC., and BECTON DICKINSON AND COMPANY, Defendants--Appellees, and BIOMERIEUX SA, Defendant.

01--1230

UNITED STATES COURT OF APPEALS FOR THE FEDERAL CIRCUIT

285 F.3d 1013; 2002 U.S. App. LEXIS 5642; 62 U.S.P.Q.2D (BNA) 1289

April 2, 2002, Decided

NOTICE:[**1] THIS OPINION WAS VACATED BY THECOURT.

SUBSEQUENT HISTORY:Vacated:Enzo Biochem, Inc., v. Gen--Probe, Inc., 2002U.S. App. LEXIS 14328(Fed. Cir. July 15, 2002).

PRIOR HISTORY:Appealed from: United States District Court forthe Southern District of New York. Judge Alvin K.Hellerstein.

DISPOSITION:Affirmed.

COUNSEL:Richard L. DeLucia, Kenyon & Kenyon, of New York,New York, argued for plaintiff--appellant. With him onthe brief were Charles A. Weiss, and Bradley S. Corsello.

William F. Lee, Hale and Dorr LLP, of Boston,Massachusetts, argued for defendants--appellees. Withhim on the brief was William G. McElwain. Of coun-sel on the brief were Robert J. Gunther, Jr., and Jeffrey A.Tochner, Latham & Watkins, of New York, New York, forChugai Pharma U.S.A., Inc. and Chugai PharmaceuticalCo., Ltd. Of counsel was Kurt M. Rogers. Of coun-sel on the brief were Daniel A. Boehnen, and JoshuaR. Rich, McDonnell Boehnen Hulbert & Berghoff, ofChicago, Illinois, for Biomerieux, Inc. Of counsel on thebrief were Donald R. Ware and Barbara A. Fiacco, FoleyHoag & Eliot LLP, of Boston, Massachusetts, for BectonDickinson and Company.

JUDGES:Before LOURIE, DYK, and PROST, Circuit Judges.Opinion for the court filed by LOURIE, Circuit Judge.

Dissenting opinion filed by Circuit Judge DYK.

OPINIONBY:LOURIE

OPINION:

[*1015]

Enzo Biochem, Inc. appeals from the decision ofthe United States District Court for the Southern [**2]District of New York granting Gen--Probe Incorporated,Chugai Pharma U.S.A., Inc., Chugai Pharmaceutical Co.,Ltd., Biomerieux, Inc., Biomerieux SA, and BectonDickinson and Company's (collectively, "the defen-dants'") motion for summary judgment that claims 1--6of U.S. Patent4,900,659are invalid for failure to meetthe written description requirement of35 U.S.C. § 112,P 1. Enzo Biochem, Inc. v. Gen--Probe Inc., No. 99 Civ.4548 (S.D.N.Y. Apr. 4, 2001) (final order). Because thedistrict court did not err in its conclusion that there wereno genuine issues of material fact and that the defendantswere entitled to judgment as a matter of law, we affirm.

BACKGROUND

Enzo is the assignee of the'659 patent, which is di-rected to nucleic acid probes that selectively hybridizeto the genetic material of the bacteria that cause gonor-rhea, Neisseria gonorrhoeae. N. gonorrhoeae reportedlyhas between eighty and ninety--three percent homologywith Neisseria meningitidis.'659patent, col. 2, ll. 61--64.Such a high degree of homology has made detection of N.gonorrhoeae difficult, as any probe capable of detectingN. gonorrhoeae may also show a [**3] positive resultwhen only N. meningitidis is present. Enzo recognizedthe need for a chromosomal DNA probe specific for N.gonorrhoeae, [*1016] and it derived three such probesthat preferentially hybridized to six common strains of N.gonorrhoeae over six common strains of N. meningitidis.Id. at col. 3, l. 49 to col. 4, l. 14; col. 4, ll. 45--50. The

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inventors believed that if the preferential hybridizationratio of N. gonorrhoeae to N. meningitidis were greaterthan about five to one, then the "discrete nucleotide se-quence will hybridize to virtually all strains of Neisseriagonorrhoeae and to no strain of Neisseria meningitidis."Id. at col. 12, ll. 60--65. The three probes that the inven-tors actually derived had a selective hybridization ratio ofgreater than fifty. Id. at col. 13, ll. 9--15. Enzo depositedthose probes in the form of a recombinant DNA moleculewithin an E. coli bacterial host at the American TypeCulture Collection. Id. at col. 13, ll. 27--31.

Claim 1, in relevant part, is as follows:

1. A composition of matter that is specific for Neisseriagonorrhoeae comprising at least one nucleotide sequencefor which [**4] the ratio of the amount of said sequencewhich hybridizes to chromosomal DNA of Neisseria gon-orrhoeae to the amount of said sequence which hybridizesto chromosomal DNA of Neisseria meningitidis is greaterthan about five, said ratio being obtained by a methodcomprising the following [sic] steps;

Id. at col. 27, ll. 29--36 (emphasis added). The methodsteps that follow are directed to obtaining the claimed ra-tio. Id. at col. 27, l. 37 to col. 28, l. 26. Claim 4 is directedto the deposited probes (referenced by their accessionnumbers) and variations thereof as follows:

4. The composition of claim 1 wherein said nucleotidesequences are selected from the group consisting of:

a. the Neisseria gonorroheae [sic] DNA insert of ATCC53409, ATCC 53410 and ATCC 53411, and discrete nu-cleotide subsequences thereof,

b. mutated discrete nucleotide sequences of any of theforegoing inserts that are within said hybridization ratioand subsequences thereof; and

c. mixtures thereof.

Id. at col. 28, ll. 31--39. Claim 6 is directed to a methodof conducting a hybridization assay with the depositedprobes and variations thereof. Id. at [**5] col. 28, ll. 47--56.

Enzo sued the defendants for infringement of the'659patent, and the defendants moved for summary judgmentthat the claims were invalid for failure to meet the writtendescription requirement of35 U.S.C. § 112,P 1. The dis-trict court, in oral remarks from the bench, granted thatmotion. Tr. of Hr'g at 42, Enzo Biochem, Inc. v. Gen--Probe, Inc., No. 99--CV--4548 (S.D.N.Y. Jan. 24, 2001)("Enzo Hearing"). It concluded that the claimed compo-sition of matter was defined only by its biological activityor function, viz., the ability to hybridize to N. gonor-rhoeae in a ratio of better than about five with respect to

N. meningitidis, which was insufficient to satisfy the §112, P 1 requirement set forth in this court's holdings inRegents of the University of California v. Eli Lilly & Co.,119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997), Fiers v.Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed. Cir. 1993),andAmgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d1200, 18 USPQ2d 1016 (Fed. Cir. 1991).Id. at 28. Thecourt rejected Enzo's argument that the reference in thespecification [**6] to the deposits of biological materialsin a public depository inherently disclosed that the inven-tors were in possession of the claimed sequences. Id. at35. It distinguished this court's cases concerning depositsas relating to the enablement requirement of § 112, P 1. Id.at 38--40. Enzo appealed to this court; we have [*1017]jurisdiction pursuant to28 U.S.C. § 1295(a)(1).

DISCUSSION

[HN1] Summary judgment is appropriate when thereis no genuine issue of material fact and the moving partyis entitled to judgment as a matter of law. Fed. R. Civ.P. 56(c);Anderson v. Liberty Lobby, Inc., 477 U.S. 242,247--48, 91 L. Ed. 2d 202, 106 S. Ct. 2505 (1986).[HN2]On motion for summary judgment, the court views theevidence and any disputed factual issues in the light mostfavorable to the party opposing the motion.MatsushitaElec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587,89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986).[HN3] A patentis presumed to be valid,35 U.S.C. § 282(1994), and thispresumption can only be overcome by facts supported byclear and convincing evidence to the contrary, see, e.g.,WMS Gaming Inc. v. Int'l Game Techs., 184 F.3d 1339,1355, 51 USPQ2d 1385, 1396--97 (Fed. Cir. 1999).[**7]"Compliance with the written description requirement is aquestion of fact . . . ."Vas--Cath Inc. v. Mahurkar, 935 F.2d1555, 1563, 19 USPQ2d 1111, 1116 (Fed. Cir. 1991).

Enzo argues that its expert, Dr. Wetmer, raised a gen-uine factual issue that the disclosure inherently describedthe claimed nucleotide sequences, and that the court erredin bypassing the factual inquiry mandated by Vas--Cathand granting summary judgment solely on the basis of thepatent's disclosure. Enzo also argues that its description ofthe binding affinity of the claimed nucleotide sequencessatisfies the requirement set forth in the Guidelines forExamination of Patent Applications Under the35 U.S.C.112,P 1 "Written Description" Requirement,66 Fed. Reg.1,099(Jan. 5, 2001) ("Guidelines"). Enzo asserts that thecourt erred in not evaluating the patentability of the claimsseparately, pointing out that claims 4 and 6 are directedto the three deposited probes and variations and mixturesthereof. Enzo further asserts that the claims per se meetthe written description requirement because they appearin ipsis verbis in the written description. [**8] Enzo alsoargues that this court's articulation of the written descrip-

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62 U.S.P.Q.2D (BNA) 1289

tion requirement for genetic material in Eli Lilly shouldnot apply to this case because Enzo reduced the inventionto practice and deposited the derived biological materials,thereby demonstrating its "possession" of the invention.

The defendants respond that the district court properlygranted summary judgment because the patent describedthe claimed nucleotide sequences only by their function,which is insufficient to meet the requirement of § 112, P1 as a matter of law under Eli Lilly, even for the narrowerclaims directed to the deposited materials. The defendantsalso assert that the expert's opinion that the deposited ge-netic materials could actually have been sequenced did notcure the actual failure of the inventors to identify them bysome distinguishing characteristic such as their structure.The defendants argue that a description of the claimedgenus of nucleotide sequences by its hybridization ratiodoes not satisfy § 112, P 1 under this court's case law andthe Guidelines. The defendants also urge that in ipsis ver-bis support for the claims in the specification does not perse [**9] establish compliance with the written descrip-tion requirement. Finally, the defendants assert that thedistrict court did not err in its determination that Enzo's"possession" of three nucleotide sequences that it reducedto practice and deposited nevertheless did not satisfy thewritten description requirement of § 112, P 1.

[HN4] The written description requirement of § 112,P 1 is set forth as follows:[*1018]

The specification shall contain a written description of theinvention, and of the manner and process of making andusing it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains orwith which it is most nearly connected, to make and usethe same, and shall set forth the best mode contemplatedby the inventor of carrying out his invention.

35 U.S.C. § 112,P 1 (1994) (emphasis added). We have in-terpreted that section as requiring a "written description"of an invention separate from enablement.Vas--Cath, 935F.2d at 1563, 19 USPQ2d at 1117(recognizing the sev-erability of the "written description" and "enablement"provisions of § 112, P 1). [HN5] Compliance with thewritten [**10] description requirement is essentially afact--based inquiry that will "necessarily vary dependingon the nature of the invention claimed." Id. (citingInre DiLeone, 58 C.C.P.A. 925, 436 F.2d 1404, 1405, 168USPQ 592, 593 (CCPA 1971)).We have also previouslyconsidered the written description requirement as appliedto certain biotechnology patents, in which a gene mate-rial has only been defined by a statement of function orresult and have held that such a statement did not ade-quately describe the claimed invention.Eli Lilly, 119 F.3dat 1568, 43 USPQ2d at 1406.In Eli Lilly, we concluded

that a claim to a microorganism containing a human in-sulin cDNA was not adequately described by a statementthat the invention included human insulin cDNA.Id. at1567, 43 USPQ2d at 1405.The recitation of the termhuman insulin cDNA conveyed no distinguishing infor-mation about the identity of the claimed DNA sequence,such as its relevant structural or physical characteristics.Id. We stated that [HN6] an adequate written descriptionof genetic material "'requires a precise definition, such asby structure, formula, chemical name, or physical [**11]properties,' not a mere wish or plan for obtaining theclaimed chemical invention."Id. at 1566, 43 USPQ2d at1404 (quoting Fiers, 984 F.2d at 1171, 25 USPQ2d at1606).The disclosure must allow one skilled in the art tovisualize or recognize the identity of the subject matter ofthe claim. Id. 119 F.3d at 1568, 43 USPQ2d at 1406.Adescription of what the genetic material does, rather thanof what it is, does not suffice. Id.

We conclude that, in this case, the district court cor-rectly determined that the specification failed to providean adequate written description of the claimed compo-sitions. The court correctly found that the claimed nu-cleotide sequence is described only by its binding to N.gonorrhoeae in a preferential ratio of "greater than aboutfive" with respect to N. meningitidis. While that descrip-tion of the ability of the claimed probe to bind to N. gonor-rhoeae may describe the probe's function, it does not de-scribe the probe itself. We reject Enzo's characterizationof the hybridization as a distinctive "chemical property"of the claimed sequences. The hybridization distinguishesthe claimed nucleotide sequences from [**12] unclaimedsequences only by what they do, which is a purely func-tional distinction.

Enzo attempts to distinguish the facts of this case fromthose in Eli Lilly by asserting that its claimed probes per-form a different function (hybridization) than that of theclaimed sequences in Eli Lilly (encoding proteins), andthat the former function is descriptive in the context ofprobes. We do not find that distinction relevant becausehybridization from one DNA segment to another is just asmuch a functional definition as translation from a nucleicacid to a protein. As stated above, a description of ge-netic material by what it does ---- such as hybridizing to N.gonorrhoeae ---- is insufficient to satisfy § 112, P 1, regard-less whether the described property [*1019] is labeled"chemical" or "functional." The defendants demonstratedthat the claims were insufficiently described as a matterof law by the clear and convincing evidence in the patentdocument itself, viz., the failure of the patent to describethe claimed sequences by anything other than their func-tion. Enzo failed to raise any genuine issues of fact as tothe actual description in the patent, which did not ade-quately characterize [**13] the claimed invention.

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62 U.S.P.Q.2D (BNA) 1289

We also disagree with Enzo that binding affinity meetsthe test of an adequate description under the Guidelines.As a preliminary matter, [HN7] the Guidelines, like theMPEP, are not binding on this court. SeeMolins PLC v.Textron, Inc., 48 F.3d 1172, 1180 n.10, 33 USPQ2d 1823,1828 n.10 (Fed. Cir. 1995)(noting that the MPEP is notbinding on this court but is "entitled to judicial noticeas an official interpretation of statutes or regulations aslong as it is not in conflict therewith"). In any event, wedo not read the Guidelines as setting forth a rule that adescription of a compound by its binding affinity is suf-ficient to satisfy § 112, P 1. Enzo points to the followingstatement in the Guidelines: "For some biomolecules, ex-amples of identifying characteristics include a sequence,structure, binding affinity, binding specificity, molecularweight, and length." Guidelines at 1110 n.42. Accordingto the Guidelines:[HN8]

An applicant may also show that an invention is completeby disclosure of sufficiently detailed, relevant identifyingcharacteristics which provide evidence that applicant wasin possession of the claimed invention, [**14] i.e., com-plete or partial structure, other physical and/or chemicalproperties, functional characteristics when coupled witha known or disclosed correlation between function andstructure, or some combination of such characteristics.

Id. at 1106 (emphasis added); see alsoSynopsis of Application of WrittenDescription Guidelines, at 60, available athttp://www.uspto.gov/web/patents/guides.htm (findingcompliance with § 112, P 1 for a claim to "an isolatedantibody capable of binding to antigen X," considering"the well defined structural characteristics for thefive classes of antibody, the functional characteristicsof antibody binding, and the fact that the antibodytechnology is well developed and mature"). Enzo'sclaims do not meet that test. Enzo has not assertedthat the claimed function is known to correlate to aspecific structure or other identifying characteristic thatis disclosed or is otherwise well known.

Moreover, the hybridization set out in the presentclaims is the only characteristic purportedly describingthe claimed nucleotide sequences. [HN9] The Guidelinesdo not provide that a nucleotide sequence may be definedonly by its function. [**15] Describing a complicatedmolecule by means of a broad generic term (a nucleotidesequence) plus its function fails to distinguish it fromother molecules that can perform the same function. Adescription of an anti--inflammatory steroid, i.e., a steroid(a generic structural term) having the function of less-ening inflammation of tissues, fails to distinguish anysteroid from others having the same activity or function.

Similarly, the expression "an antibiotic penicillin" failsto distinguish a particular penicillin molecule from oth-ers possessing the same activity. Thus, in the absence ofsequence information for its hybridization site, a nucleicacid described only by its ability to hybridize with anotherDNA fails to meet the requirements of § 112, P 1.

The written description requirement reflects the quidpro quo of our patent system, in which an inventor is onlyentitled to claim subject matter that is adequately de-scribed to the public. While [*1020] Enzo may have de-rived three nucleotide sequences that exploit some regionor regions of non--homology between N. gonorrhoeae andN. meningitidis, its broad claims are directed to all se-quences that differentiate between the [**16] two strainsof bacteria. The subject matter of the narrow claims (di-rected to the deposited probes and various permutationsthereof) is similarly defined only by the function of theclaimed probes, which does not identify the chemicalstructure of the probes themselves. In effect, Enzo madean invention of a nucleotide sequence to diagnose the pres-ence of N. gonorrhoeae and claimed it in circular fashionas any nucleotide sequence that hybridizes with N. gonor-rhoeae so as to diagnose its presence. Stated another way,Enzo claimed anything that works, without defining whatworks.

We are not persuaded by Enzo's arguments that thecourt failed to consider the separate patentability of theclaims. In its remarks, the court evaluated the separatelimitations of each of the claims and related those lim-itations to its previous Markman determinations. EnzoHearing at 17--19. The court also clearly identified thefatal flaw in Enzo's claims: "What we have here is a defi-nition by biological activity and function ---- that is, affinityof a [sic] yielding a ratio of better than five ---- not of itsinherent structure." Id. at 28. That flaw is true of all ofthe claims, even [**17] those directed to the probes thatEnzo actually made.

We also conclude that Enzo's claims do not meet thewritten description requirement simply because they arein ipsis verbis supported by the specification. Even if aclaim is supported by the specification, the language ofthe claim must describe the invention so that one skilledin the art can recognize what is claimed. The appearanceof the words of the claim in the specification or as an orig-inal claim does not necessarily satisfy that requirement.Indeed, in Eli Lilly, we were faced with another set offacts in which the words of the claim alone did not con-vey an adequate description of the invention.119 F.3d at1567, 43 USPQ2d at 1405.In such a situation, regardlesswhether the claim appears in the original specificationand is thus supported by the specification as of the filingdate, § 112, P 1 is not met. See Guidelines at 1100 (noting

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Eli Lilly's repudiation of the "original claim" doctrine forsituations in which the name of the claimed material doesnot convey sufficient identifying information). [HN10]If a purported description of an invention does not meetthe requirements of the statute, [**18] the fact that itappears as an original claim or in the specification doesnot save it. A claim does not become more descriptive byits repetition, or its longevity.

Enzo also urges that it has complied with the § 112, P 1"possession" test in Vas--Cath by reducing its invention topractice and depositing the resulting nucleotide sequencesin a public depository. We disagree. It is true that in Vas--Cath, we stated: "[HN11] The purpose of the 'written de-scription' requirement is broader than to merely explainhow to 'make and use'; the applicant must also conveywith reasonable clarity to those skilled in the art that, asof the filing date sought, he or she was in possession of theinvention."Vas--Cath, 935 F.2d at 1563--64, 19 USPQ2dat 1117.That portion of the opinion in Vas--Cath, how-ever, merely states a purpose of the written descriptionrequirement, viz., to ensure that the applicant had posses-sion of the invention as of the desired filing date. It doesnot state that possession alone is always sufficient to meetthat requirement. Furthermore, in Lockwood v. AmericanAirlines, Inc., we rejected Lockwood's argument that "allthat is necessary [**19] to satisfy [*1021] the descriptionrequirement is to show that one is 'in possession' of theinvention."107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966(Fed. Cir. 1997).Rather, we clarified that [HN12] the writ-ten description requirement is satisfied by the patentee'sdisclosure of "such descriptive means as words, struc-tures, figures, diagrams, formulas, etc., that fully set forththe claimed invention." Id.

[HN13] The articulation of the written description re-quirement in terms of "possession" is indeed useful whena patentee is claiming entitlement to an earlier filing dateunder35 U.S.C. §§ 119or 120, in interferences in whichthe issue is whether a count is supported by the specifi-cation of one or more of the parties, and in ex parte ap-plications in which a claim at issue was filed subsequentto the application. SeeVas--Cath, 935 F.2d at 1560, 19USPQ2d at 1114(describing situations in which the writ-ten description requirement may arise);Ralston PurinaCo. v. Far--Mar--Co, Inc., 772 F.2d 1570, 1575, 227 USPQ177, 179 (Fed. Cir. 1985)(noting, in the context of claim-ing entitlement to the priority date of an earlier appli-cation, [**20] that the written description requirementis met if "the disclosure of the application relied uponreasonably conveys to the artisan that the inventor hadpossession at that time of the later claimed subject mat-ter"). Application of the written description requirement,however, is not subsumed by the "possession" inquiry.A showing of "possession" is secondary to the statutory

mandate that "the specification shall contain a written de-scription of the invention," and that requirement is notmet if, despite a showing of possession, the specificationdoes not adequately describe the claimed invention. Afterall, one can show possession of an invention by means ofan affidavit or declaration during prosecution, as one doesin an interference or when one files an affidavit under37C.F.R. § 1.131to antedate a reference. However, such ashowing of possession does not substitute for a writtendescription in the specification, as required by statute.

[HN14] The written description requirement is themost basic requirement of the patent law ---- to adequatelyidentify what one has invented. It is true that knowledgeof one skilled in the art is relevant to meeting that [**21]requirement, as it is to enablement. An invention may beproperly enabled even if some experimentation is requiredto practice it, provided that experimentation is not undue.However, to require the public to go to a public deposi-tory and perform experiments to identify an invention isnot consistent with the statutory requirement to describeone's invention in the specification.

Enzo's "possession" of the invention does not con-tribute to its description in the patent specification. True,Enzo apparently has achieved more than a "wish" ora "plan" for obtaining the claimed genetic material.However, its mere possession of three nucleotide se-quences that are within the scope of the claims does notprovide sufficient distinguishing information about thosesequences for purposes of satisfying § 112, P 1. Enzo pro-vided only vague details about the nucleotide sequences:how they were obtained (but not meaningfully identified)and their approximate lengths.'659patent, col. 13, ll. 26--60; col. 26, l. 56 to col. 27, l. 20. That meager informa-tion does not allow one skilled in the art to visualize orrecognize the identity of the claimed subject matter.

Moreover, we disagree with Enzo [**22] that biolog-ical deposits necessarily satisfy the written descriptionrequirement. In Lundak, we clarified that the "deposit re-quirement applies only to biological materials that are notreadily reproducible from their written description" andreversed a [*1022] rejection by the Board for failure tomeet the enablement requirement by a post--filing date de-posit.In re Lundak, 773 F.2d 1216, 1217, 227 USPQ 90,92 (Fed. Cir. 1985).We also reversed the Board's holdingthat the post--filing date deposit violated the prohibitionagainst new matter in35 U.S.C. § 132. Id. at 1223, 227USPQ at 95.We stated that: "An accession number anddeposit date add nothing to the written description of theinvention. They do not enlarge or limit the disclosure."Id. at 1223, 227 USPQ at 96.Lundak thus supports ourconclusion that Enzo's disclosure that it deposited embod-iments of the invention does not ipso facto describe that

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invention.

There are other reasons why a public deposit does notsubstitute for a description of an invention in the specifi-cation. [HN15] An adequate description is necessary forproper examination of an application. [**23]Lundak,773 F.2d at 1223, 227 USPQ at 95("The examination forpatentability proceeds solely on the basis of the writtendescription."); Guidelines at 1107--08 n.6 ("The writtendescription of the deposited material needs to be as com-plete as possible because the examination for patentabilityproceeds solely on the basis of the written description.").Furthermore, the Guidelines state that "'once the patentissues, the description must be sufficient to aid in the reso-lution of questions of infringement.'" Guidelines at 1107--08 n.6 (quoting Deposit of Biological Materials for PatentPurposes, Final Rule,54 Fed. Reg. 34,864, 34880(Aug.22, 1989) (codified at 37 C.F.R. pt. 800)).

We therefore conclude that "[HN16] a deposit is not asubstitute for a written description of the claimed inven-tion." Guidelines at 1107--08 n.6. Even if Enzo's expert,Dr. Wetmur, were correct that one of skill in the art couldroutinely sequence the deposited material and so obtaina description of those deposits, that description is not inthe patent. The written description requirement is not sat-isfied by what could have been disclosed, but was not.See Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966[**24] (stating that the description requirement is notmet by combining the actual disclosure with knowledgein the art).

Finally, Enzo asserts that a reduction to practice issufficient to satisfy the written description requirementunder the Guidelines. Specifically, the Guidelines pro-vide examiners with a methodology for determining theadequacy of the written description. The Guidelines readas follows:

[HN17] Description of an actual reduction to practiceoffers an important "safe haven" that applies to all ap-plications and is just one of several ways by which anapplicant may demonstrate possession of the claimed in-vention. Actual reduction to practice may be crucial inthe relatively rare instances where the level of knowledgeand level of skill are such that those of skill in the artcannot describe a composition structurally, or specify aprocess of making a composition by naming componentsand combining steps, in such a way as to distinguish thecomposition with particularity from all others. Thus, theemphasis on actual reduction to practice is appropriate inthose cases where the inventor cannot provide an adequatedescription of what the composition is, and a definitionby [**25] function is insufficient to define a composition"because it is only an indication of what the [composition]does, rather than what it is."Eli Lilly, 119 F.3d at 1568,

43 USPQ at 1406.

Id. at 1101. This is not a case in which the inventorscould not have provided a description of the nucleotidesequences. Moreover, we do not purport to indicate howthe Guidelines apply to cases not before [*1023] us.Although an actual reduction to practice, assuming oneexists here, may demonstrate possession of an embod-iment of an invention, it does not necessarily describewhat the claimed invention is. In the context of this case,the disclosure of the way the invention was reduced topractice does not satisfy the more fundamental writtendescription requirement set forth in the statute: "the spec-ification shall contain a written description . . . ." Enzo hasmerely disclosed that it obtained the sequences, but it hasnot identified them. We therefore conclude that Enzo'sdescription of its reduction to practice, unaccompaniedby any written disclosure of meaningful, distinguishingcharacteristics of the claimed invention, does not satisfythe written description requirement [**26] of § 112, P 1.

A few comments are in order relating to the dissent.Although determination whether the written descriptionrequirement has been met raises factual issues, no fact--finding is needed to determine, as the trial court did, thatthe claimed nucleotide sequences are identified here onlyby their function. Such an omission renders the applica-tion legally deficient in terms of satisfying the writtendescription requirement.

The dissent indicates that the degree of hybridiza-tion between a probe and a bacterial target depends onthe degree of complementarity between the structures ofthe probe and the bacterium. That is true, but, failing adescription of the sequence of a bacterium in the specifi-cation, including the specific point on the sequence thatbinds to the probe, there is no written description of theclaimed invention in the specification. The specificationacknowledges that the sequences of the bacteria were notdetermined.'659patent, col. 3, ll. 39--46.

The dissent states that deposit of a sample of the in-vention in a recognized depository "is an ideal way" ofsatisfying the written description requirement. We do notagree. Deposits originated as a means of [**27] enablingpractice of the invention when a unique starting materialis required to practice it. Without a description of what theinvention is, however, the notice function of a descriptionin the patent has still not been satisfied. What the depositdoes, in addition to enabling the practice of the inven-tion, is tell the public where a sample of the invention canbe found so that the invention can be carried out whenthe patent expires or used in other ways that may not in-fringe the patent. That is not describing the invention inthe patent. The dissent notes that it is ironic that we do not

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question the use of the depository to describe the objectof the invention. That is not the purpose of a depository. Adepository is not part of a patent specification. It exists toprovide samples of microorganisms, for patent purposesand otherwise.

The dissent indicates that the PTO found the referenceto the deposited materials to be sufficient. While it is truethat the PTO did not make a written description rejectionrelating to the deposit, it is also clear that its objectionconcerning the deposit, which was later satisfied, relatedto enablement, which has traditionally been the purpose[**28] of a deposit. Here, in contrast to the use of a mi-croorganism to make another invention, which raises theenablement issue, the deposit here essentially contains theinvention, and the invention must be described more thanby stating that it exists in a depository.

CONCLUSION

For the foregoing reasons, we conclude that the dis-trict court did not err in granting summary judgment thatthe claims of [*1024] the'659patent are invalid for fail-ure to meet the written description requirement of § 112,P 1. The district court clearly understood the governingcase law and Enzo's patent specification.

AFFIRMED

DISSENTBY:DYK

DISSENT:

DYK, Circuit Judge, dissenting.

This case presents two significant issues relating to thewritten description requirement -- one old and one new. Irespectfully dissent from the majority's decision on eachof these issues and its decision to hold the claims of U.S.Patent No.4,900,659(the " '659patent") invalid.

First, the majority, like the district court, holds that allclaims fail to satisfy the written description requirementas a matter of law. It is well established that the writ-ten description requirement presents a factual issue. Ourestablished precedent [**29] requires a determinationwhether one skilled in the art at the time the applicationwas filed would understand the nature of the claimed in-vention from the written description. No adequate recordfor summary judgment has been made in this case on thatissue, much less a record that establishes invalidity byclear and convincing evidence as a matter of law. Second,with respect to claims 4 and 6 the majority holds that a de-posit in the American Type Culture Collection ("ATCC")cannot be used to satisfy the written description require-ment. This is a matter of first impression, but I suggest that

the majority's decision is both incorrect and unfortunatefrom the perspective of sound public policy.

1. All Claims

Claim 1 essentially claims nucleotide sequenceswhich selectively hybridize to the DNA of N. gonorrhoeaeas opposed to hybridizing to the DNA of N. meningitidis.Claim 5 essentially claims a method of detecting N. gon-orrhoeae by using the nucleotide sequence of claim 1 asa probe. Claims 1 and 5 may be characterized as genusclaims, as the claimed nucleotide sequence is not lim-ited to a particular species. The other claims of the patent(claims 2, 3, 4, and 6) [**30] depend from either claim 1or 5. The specification discloses, in great detail, the imple-mentation of well--known screening methods for isolatingthe claimed nucleotide sequences.'659 Patent, col. 4, l.46 -- col. 12, l. 65. Two embodiments of the claimed nu-cleotide sequences are described as having about 850 basepairs and one other embodiment is described as havingabout 1300 base pairs. The claimed sequences are definedby their selective hybridization to the DNA of six specif-ically identified strains of N. gonorrhoeae which are ondeposit with the ATCC as opposed to hybridizing to theDNA of six specifically identified strains of N. meningi-tides on deposit with the ATCC.

The defendant--appellees sought to invalidate theclaims of the patent for failure to satisfy the written de-scription requirement. When moving for summary judg-ment on the issue of invalidity, they did not rely on anytestimony from anyone of ordinary skill in the art. n1 Theyrelied purely on attorney argument to support their claimas to why the claims do not satisfy the written descriptionrequirement. The district court held as a matter of lawbased on its own examination of the text of the patentthat [**31] the patent was invalid for failure to satisfythe written description requirement. The majority agreeswith the defendants' argument that the specification "isinsufficient to meet the [*1025] requirement of § 112, P1 as a matter of law .. . ." Ante at 5.

n1 Appellees apparently submitted a declara-tion from Dr. Philip Sparling, but concede here thatthey did not rely on this declaration when movingfor summary judgment.

We have repeatedly held, including in Eli Lilly, that"whether a specification complies with the written de-scription requirement of § 112, P 1, is a question of fact. . . ."Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997),cert.denied523 U.S. 1089 (1998).Moreover, the sufficiency ofthe description is measured from the point of view of oneof ordinary skill in the art as of the time the description

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62 U.S.P.Q.2D (BNA) 1289

is filed. Reiffin v. Microsoft Corp., 214 F.3d 1342, 1346,54 USPQ2d 1915, 1917--18 (Fed. Cir. 2000).[**32] InIn re Alton, 76 F.3d 1168, 1174--75, 37 USPQ2d 1578,1583--84 (Fed. Cir. 1996),this court reversed a decision ofthe Patent and Trademark Office ("PTO") Board of PatentAppeals and Interferences ("Board") upholding an exam-iner's rejection of Alton's patent application for failure tocomply with the written description requirement. Altonhad submitted a declaration from one of ordinary skill inthe art stating that one of ordinary skill in the art wouldhave understood the specification as adequately describ-ing the claimed invention.Id. at 1172--73, 37 USPQ2dat 1581--82.The examiner gave little or no weight to thisdeclaration, contending that it was "an opinion affadaviton the ultimate legal question at issue."Id. at 1174, 37USPQ2d at 1583.We reversed because the examiner andthe Board applied the wrong legal standard by viewing thedeclaration as addressing a question of law rather than aquestion of fact, and required the PTO to evaluate theexpert's affadavit as bearing on the factual issue. Id.

The majority here finds support for its approach inEli Lilly. Eli Lilly, in departing from the general rule that[**33] an applicant satisfies the written description re-quirement by "conveying with reasonable clarity to thoseskilled in the art that, as of the filing date sought, he orshe was in possession of the invention,"Vas--Cath Inc. v.Mahurkar, 935 F.2d 1555, 1563--64, 19 USPQ2d 1111,1117 (Fed. Cir. 1991),and imposing a unique written de-scription requirement in the field of biotechnology, is opento serious question. But even Eli Lilly does not sanctionthe approach taken here. Eli Lilly recognized, of course,that there are situations in which the written descriptionis so deficient that it fails to satisfy the written descrip-tion requirement as a matter of law. In Eli Lilly itself thepatent claimed "2. [a] recombinant procaryotic microor-ganism modified to contain a nucleotide sequence havingthe structure of the reverse transcript of an mRNA of avertebrate, which mRNA encodes insulin," U.S. PatentNo. 4,652,525, col. 21, ll. 1--5, and "5. [a] microorganismaccording to claim 2 wherein the vertebrate is a human."Id. at col. 22, ll. 3--4. The claimed "reverse transcript ofan mRNA [also known as "cDNA"] of a vertebrate" wasnot described by sequencing. [**34] Instead, the patentsimply named the cDNA and described the process thatcould be used for isolating it. We held:

The name cDNA is not itself a written description of thatDNA; it conveys no distinguishing information concern-ing its identity. While the example provides a process forobtaining human insulin--encoding cDNA, there is no fur-ther information in the patent pertaining to that cDNA'srelevant structural or physical characteristics; in otherwords, it thus does not describe human insulin cDNA.Describing a method of preparing a cDNA or even de-

scribing the protein that the cDNA encodes, as the exam-ple does, does not necessarily describe the cDNA itself.No sequence information indicating which nucleotidesconstitute [*1026] human cDNA appears in the patent,as appears for rat cDNA in Example 5 of the patent.Accordingly, the specification does not provide a writtendescription of the invention of claim 5.

Eli Lilly, 119 F.3d at 1567, 43 USPQ2d at 1405.

The patent here is quite different. It states that theclaimed nucleotide sequences specifically hybridize tothe DNA of particular strains of N. gonorrhoeae on de-posit with the ATCC and not to the [**35] DNA ofparticular strains of N. meningitidis on deposit with theATCC. The parties agree that this selective hybridizationof the claimed sequences is indicative of a structure thatis more complementary to the structures of the DNAs ofthe disclosed N. gonorrhoeae strains than to those of theN. meningitidis strains. As the majority correctly pointsout "Enzo may have derived three nucleotide sequencesthat exploit some region or regions of non--homology be-tween N. gonorrhoeae and N. meningitidis . . . ." Ante at10. The majority discounts this description as merelyfunctional, ante at 8, 10, but I view the description asidentifying a structural difference between the DNAs ofN. gonorrhoeae and N. meningitidis. The property of theclaimed nucleotide sequences hybridizing to particular,known DNAs is a direct result of the structure of the nu-cleotide sequence. The degree of hybridization between aprobe and a target depends on the degree of complemen-tarity between the chemical structure between the probeand the target. To be sure, the sequences and the chemicalstructure of the targets were not disclosed in the speci-fication, but the targets were [**36] not novel, and the"Background" section of the patent states that the degreeof homology between the N. gonorrhoeae and N. menin-gitidis DNA targets was known to be between 80% to93%. '659patent, col. 2, ll. 61--64. This indicates that thestructure of the targets was at least somewhat known tothose of skill in the art. Thus, by describing the degreeof hybridization of the claimed nucleotide sequences, thespecification may adequately describe the structure of theclaimed sequences. At least one of ordinary skill in theart might so conclude. There has been no factual showingthat one of skill in the art would not understand that theclaimed invention is described by a written description ofits hybridization--specific properties. n2

n2 The majority faults the specification for fail-ing to describe the amino acid sequences of the tar-gets, and points out that the patent itself acknowl-edges that the sequences of the targets were notdetermined. Ante at 17. But the patent states the rea-son the sequences were not determined is because

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62 U.S.P.Q.2D (BNA) 1289

at the time of the filing of the application in 1986"it would [have] taken 3,000 scientists one monthto sequence the genome of one strain of Neisseriagonorrhoeae and one strain of Neisseria meningi-tidis." '659patent, col. 3, ll. 43--46. I do not believethat the patent laws require such a Herculean efforton the part of the patentee when one of ordinaryskill in the art might understand the nature of hisinvention from a simpler written description of it.

[**37]

In light of the appellees' failure to make a factualshowing supporting summary judgment, we should re-verse the district court's summary judgment of invalidityand remand to the district court for a factual finding, af-ter a hearing, of whether one of ordinary skill in the artwould consider the specification to describe the claimedinvention.

2. Claims 4 and 6.

Claims 4 and 6, which depend from claims 1 and 5,respectively, provide an even more detailed written de-scription. They are directed to the nucleotide sequencesof particular deposited samples, [*1027] deposited withthe ATCC. The samples are identified by their depositionnumbers, ATCC 53409, ATCC 53410, ATCC 53411, andwere deposited on January 9, 1986, twenty--one days be-fore the patent application was filed.'659patent, col. 13,ll. 9--13.

Claim 4 depends from claim 1, and further limitsclaim 1 to "nucleotide sequences .. . selected from thegroup consisting of: (a.) the Neisseria gonorroheae DNAinsert of ATCC 53409, ATCC 53410 and ATCC 53411,and discrete nucleotide subsequences thereof, (b.) mu-tated discrete nucleotide sequences of any of the fore-going inserts that are within said hybridization ratio andsubsequences [**38] thereof; and (c.) mixtures thereof."'659patent, col. 28, ll. 33--39 (first emphasis added).

Claim 6 depends from claim 5, and further limits claim5 to a screening method using a polynucleotide probe inwhich the "polynucleotide probe is a composition selectedfrom the group consisting of the Neisseria gonorrhoeaeDNA insert of ATCC 53409, ATCC 53410 and ATCC53411, and discrete nucleotide subsequences thereof; andmutated discrete nucleotide subsequences of any of theforegoing inserts . . . ."'659Patent, col. 28, ll. 47--52 (firstemphasis added).

On the face of it, a specification that describes theinvention by reference to a deposit of a sample of the in-vention in a recognized depository is an ideal way of sat-isfying the written description requirement. The primarypurpose of the statutory written description requirement

is to provide notice to competitors and the public of thescope of the patent claims. The Supreme Court has statedthat

The object of the statute is to require the patentee to de-scribe his invention so that others may construct and useit after the expiration of the patent and "to inform thepublic during the life of the patent of the limits [**39]of the monopoly asserted, so that it may be known whichfeatures may be safely used or manufactured without alicense and which may not."

Schriber--Schroth Co. v. Cleveland Trust Co., 305 U.S.47, 57, 83 L. Ed. 34, 59 S. Ct. 8 (1938)(quotingPermutitCo. v. Graver Corp., 284 U.S. 52, 60, 76 L. Ed. 163, 52S. Ct. 53 (1931)).Our predecessor court stated that "the'essential goal' of the description of the invention require-ment is to clearly convey the information that an applicanthas invented the subject matter which is claimed."In reBarker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4(CCPA 1977),cert. denied434 U.S. 1064, 55 L. Ed. 2d764, 98 S. Ct. 1238 (1978).A description by reference tothe deposited sample provides a precise and unmistakablyclear description of the invention that is accessible to thepublic.

However, the majority correctly points out that thewritten description requirement has a second purpose ----to enable the PTO to conduct an examination of the patentapplication. The majority holds that reference to the de-posited samples in claims 4 and 6 does not satisfy thewritten description [**40] requirement of35 U.S.C. § 112because "an adequate description is necessary for properexamination of an application" and "the examination ofthe application for patentability proceeds solely on thebasis of the written description." Ante at 14. The majorityconcludes that "a deposit is not a substitute for a writtendescription." Ante at 15. I think that reference to depositsis sufficient for proper examination of applications.

First, in the context of biotechnology inventions, thePTO has adopted regulations governing the deposit ofbiological materials. §§37 C.F.R 1.801-- 1.809. Thoseregulations provide inter alia that "where an invention is,or relies on, a biological material, the disclosure may in-clude [*1028] reference to a deposit of such biologicalmaterial."37 C.F.R. § 1.802(a)(2001). Section 1.803 es-tablishes criteria a depository must meet in order to beacceptable for the purposes of the PTO. When a depositis made in an acceptable depository, "the examiner shalldetermine .. . if a deposit is needed, and if needed, if adeposit actually made is acceptable for patent purposes."[**41] 37 C.F.R. § 1.809(a)(2001) (emphases added).The regulations merely require that the specification con-tain "[a] description of the deposited biological materialsufficient to specifically identify it and to permit exam-

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62 U.S.P.Q.2D (BNA) 1289

ination." 37 C.F.R. § 1.809(d)(3)(2001). When adopting§ 1.809(d)(3), the PTO specifically rejected a sugges-tion that would have required an application to contain aspecification that would "fully identify and describe thedeposited material." Deposit of Biological Materials forPatent Purposes,54 Fed. Reg. 34,864, 34,874(Aug. 22,1989). In short, the PTO has made clear that applicantsmay take advantage of a biological depository, and con-templates that deposited material may be used for writtendescription purposes. There is no necessity that the PTOactually examine the cell deposits when determining thatthe patent satisfies the written description requirement.

Second, the examiner did not here find the writtendescription inadequate for examination purposes. If theexaminer here had rejected the application for failure tosatisfy the written description requirement and had in-sisted on a written [**42] description that set forth thegene sequencing, on an appeal from the Board we wouldhave quite a different question. But the possibility that thePTO could require something more in the way of a writtendescription should not cause us to reject cell deposits assatisfying the written description requirement when thePTO has concluded, as here, that the cell deposit is suffi-cient for written description purposes and the PTO's ownexamination.

In the examiner's first Office action the examiner rec-ognized the importance of the deposited materials andrequired the applicant to assure public access to the mi-croorganisms. The examiner stated:

The specification is objected to under35 U.S.C. 112,firstparagraph, as failing to provide an enabling disclosure.

Applicants are required to assure public access to the de-posited microorganisms. The requirements are: The dura-tion of the deposit be for 30 years from the date of depositor for 5 years after the last request for the deposit at thedepository or for the enforceable life of the U.S. patentwhichever is longest. Also all of the other requirements ofMPEP 608--01(p) Section C are in effect. It is also [**43]required that the organisms will be replenished shouldthey become non--viable.

Claims 1--8 are rejected under35 U.S.C. 112,first para-graph, for the reasons set forth in the above objection tothe specification.

The patentee did what the examiner required. In thisOffice action, the examiner rejected the claims under35U.S.C. § 112for failing to provide an enabling disclosure.However, the examiner did not reject the claims for failure

to comply with the written description requirement andeventually approved the application. And the examinerspecifically addressed the applicant's use of the deposi-tory, but did not object to the application on written de-scription grounds. The PTO's acceptance of the adequacyof the written description here reflects a determination bythe PTO, pursuant to37 C.F.R. § 1.809, that the depositedmaterial was "acceptable for patent purposes," includingcompliance with the written description requirement andthat review of the deposit and a description in the spec-ification by sequencing was [*1029] unnecessary forPTO examination. Nevertheless, the majority invalidatesall claims [**44] of the patent on the same record thatthe PTO had before it.

The consequence of the majority's approach, I think,is considerable unfairness to an applicant which, findingno statutory or regulatory bar to reliance on a cell depositfor written description purposes, and finding that the PTOitself is satisfied with reliance on a cell deposit, secures apatent that relies on a cell deposit only to have this courtconclude after the fact that this reliance is impermissible.At this point it is far too late to amend the application,which was deemed satisfactory by the PTO. If the cell de-posit were inadequate for public notice purposes, the ma-jority's approach would be quite appropriate. But wherethe only purpose served by our insistence on a better writ-ten description is to enable the PTO's own examination,and the PTO itself was satisfied, we should not be second--guessing the PTO's own judgment. Cf.Dethmers Mfg.Co. v. Automatic Equip. Mfg. Co., 272 F.3d 1365, 1379,60 USPQ2d 1929, 1939 (Fed. Cir. 2001)(Dyk, J., dissent-ing) ("We are obligated by clear Supreme Court precedentto give deference to the PTO's own interpretation of itsregulations.").

The practical [**45] effect of the majority's holdingthat reference to the depository is insufficient to satisfythe written description requirement is to make descriptionby reference to the depository impossible. This is quiteinconsistent with the statutory and regulatory scheme. n3

n3 Ironically, the majority raises no questionabout the use of the ATCC depository to describethe object of the invention -- to create a probe thatspecifically hybridizes to known strains of N. gon-orrhoeae on deposit with the ATCC and not to par-ticular strains of N. meningitidis on deposit withthe ATCC.

For these reasons, I respectfully dissent.

1 of 3 DOCUMENTS



01--1230


296 F.3d 1316; 2002 U.S. App. LEXIS 14328; 63 U.S.P.Q.2D (BNA) 1609

July 15, 2002, Decided

PRIOR HISTORY:[**1] Appealed from: United States District Courtfor the Southern District of New York. Judge Alvin K.Hellerstein. vacated,Enzo Biochem, Inc. v. Gen--ProbeInc., 285 F.3d 1013,(Fed. Cir. 2002)

reversed and remanded,Enzo Biochem, Inc. v. Gen--ProbeInc., 2001 U.S. Dist. LEXIS 23791(S.D.N.Y. Apr. 4, 2001)

DISPOSITION:Prior appellate decision vacated and decision of districtcourt reversed and remanded upon rehearing.

COUNSEL:Richard L. Delucia, Kenyon & Kenyon, of New York,New York, filed a petition for rehearing for plaintiff--appellant. With him on the petition were Charles A. Weissand Bradley S. Corsello.

The appellees filed a consolidated response to the peti-tion for rehearing en banc. William F. Lee, Hale and DorrLLP, of Boston, Massachusetts, for defendant--appelleeGen--Probe Incorporated. With him on the response wasWilliam G. McElwain.

Robert J. Gunther, Jr., Latham & Watkins, of New York,New York, for defendants--appellees Chugai PharmaU.S.A., Inc. and Chugai Pharmaceutical Co., Ltd. Withhim on the response was Jeffrey A. Tochner. Of counselwas Kurt M. Rogers.

Daniel A. Boehnen, McDonnell Boehnen Hulbert &Berghoff, of Chicago, Illinois, for defendant--appelleeBiomerieux, Inc. With him on the response was JoshuaR. Rich.

Donald R. Ware, Foley Hoag & Eliot LLP, of Boston,Massachusetts, for defendant--appellee Becton Dickinsonand Company. With him on the response was Barbara A.Fiacco.

Frank P. Porcelli, Fish & Richardson P.C., [**2] ofBoston, Massachusetts, filed a brief for amicus curiaeFish & Richardson P.C. Of counsel on the brief wereRobert E. Hillman and Charles H. Sanders.

Mark S. Davies, Attorney, Appellate Staff, Civil Division,Department of Justice, of Washington, DC, filed an am-icus curiae brief for the United States in support of re-hearing en banc. With him on the brief were Robert D.McCallum, Jr., Assistant Attorney General, and Scott R.McIntosh, Attorney. Of counsel on the brief was John M.Whealan, Solicitor, U.S. Patent and Trademark Office, ofArlington, Virginia.

JUDGES:Before LOURIE, DYK, and PROST, Circuit Judges.

OPINIONBY:LOURIE

OPINION:

[*1320]

ON PETITION FOR REHEARING

LOURIE, Circuit Judge.

Enzo Biochem, Inc. petitions for rehearing of this ap-peal following our prior decision, reported at285 F.3d1013, 62 U.S.P.Q.2D (BNA) 1289 (Fed. Cir. 2002),inwhich we affirmed the decision of the United StatesDistrict Court for the Southern District of New York.The district court had granted Gen--Probe Incorporated,Chugai Pharma U.S.A., Inc., Chugai Pharmaceutical Co.,Ltd., Biomerieux, Inc., Biomerieux SA, and BectonDickinson and Company's (collectively, "the defen-dants'") motion for summary [**3] judgment that claims1--6 of U.S. Patent4,900,659are invalid for failure to meetthe written description requirement of35 U.S.C. § 112,P 1. Enzo Biochem, Inc. v. Gen--Probe Inc., 2001 U.S.

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63 U.S.P.Q.2D (BNA) 1609

Dist. LEXIS 23791 (S.D.N.Y. 2001)(final order). Havingconsidered Enzo's petition for rehearing and the defen-dants' response, n1 we have determined that our priordecision that a deposit may not satisfy the written de-scription requirement was incorrect. We therefore grantEnzo's petition for rehearing, vacate the prior decision,and reverse the district court's grant of summary judg-ment that Enzo's claims are invalid for failure to meet thewritten description requirement. Because genuine issuesof material fact exist regarding satisfaction of the writtendescription requirement, we remand.

n1 Amicus curiae briefs were filed by the UnitedStates Patent and Trademark Office and Fish &Richardson P.C.

BACKGROUND

Enzo is the assignee of the'659 patent, which is di-rected to nucleic acid probes that [**4] selectively hy-bridize to the genetic material of the bacteria that causegonorrhea, Neisseria gonorrhoeae. N. gonorrhoeae re-portedly has between eighty and ninety--three percent ho-mology with Neisseria meningitidis.'659 patent, col. 2,ll. 61--64. Such a high degree of homology [*1321] hasmade detection of N. gonorrhoeae difficult, as any probecapable of detecting N. gonorrhoeae may also show a pos-itive result when only N. meningitidis is present. Enzo rec-ognized the need for a chromosomal DNA probe specificfor N. gonorrhoeae, and it derived three such sequencesthat preferentially hybridized to six common strains of N.gonorrhoeae over six common strains of N. meningitidis.Id. at col. 3, l. 49 to col. 4, l. 14; col. 4, ll. 45--50. The in-ventors believed that if the preferential hybridization ratioof N. gonorrhoeae to N. meningitidis were greater thanabout five to one, then the "discrete nucleotide sequence[would] hybridize to virtually all strains of Neisseria gon-orrhoeae and to no strain of Neisseria meningitidis." Id.at col. 12, ll. 60--65. The three sequences that the inven-tors actually derived had a selective hybridization [**5]ratio of greater than fifty. Id. at col. 13, ll. 9--15. Enzodeposited those sequences in the form of a recombinantDNA molecule within an E. coli bacterial host at theAmerican Type Culture Collection. Id. at col. 13, ll. 27--31.

Claim 1 is as follows:

1. A composition of matter that is specific for Neisseriagonorrhoeae comprising at least one nucleotide sequencefor which the ratio of the amount of said sequence whichhybridizes to chromosomal DNA of Neisseria gonor-rhoeae to the amount of said sequence which hybridizesto chromosomal DNA of Neisseria meningitidis is greaterthan about five, said ratio being obtained by a method

comprising the following steps;

(a) providing a radioactively labeled form of said nu-cleotide sequence;

(b) providing a serial dilution series of purified chromo-somal DNA from each of the N. gonorrhoeae strains; (1)ATCC 53420, (2) ATCC 53421, (3) ATCC 53422, (4)ATCC 53423, (5) ATCC 53424, (6) ATCC 53425, andforming test dots from each of said dilution series on amatrix;

(c) providing a serial dilution series of purified nucleotidesequences from each of the N. meningitidis strains: (1)ATCC 53414, (2) [**6] ATCC 53415, (3) ATCC 53416,(4) ATCC 53417, (5) ATCC 53418, (6) ATCC 53419, andforming test dots from each of said dilution series on amatrix;

(d) hybridizing equal portions of the labeled nucleotidesequences to the matrix provided in step (b) and (c), re-spectively; wherein the hybridization is conducted in asolution having a salt concentration of 2X SSC at (i) 65degrees C. in cases in which the sequence has greater than50 base pairs or (ii) at Tm ( degrees C.) minus 30 degreesC. in cases in which the sequence has less than 50 basepairs, wherein Tm is the denaturation temperature of thesequence;

(e) quantifying the labeled nucleotide sequence hy-bridized in step (d) to each test dot;

(f) subtracting from the data of step (e) an averagedamount of radioactivity attributable to background to ob-tain a corrected amount of hybridized radioactivity at eachtest dot;

(g) normalizing the data of step (f) by multiplying theamount of corrected radioactivity at each test dot by afactor which adjusts the amount of radioactivity to equalamounts of chromosomal DNA at each test dot;

(h) selecting two normalized values that are most nearlythe same and that correspond [**7] to adjacent mem-bers [*1322] of the dilution series for each of the abovestrains of N. gonorrhoeae and obtaining the average of theselected values;

(i) selecting two normalized values that are most nearlythe same and that correspond to adjacent members of thedilution series for each of the above strains of N. menin-gitidis and obtaining the average of the selected values;

(j) dividing the lowest average obtained in step (h) by thehighest average obtained in step (i) to obtain said ratio.

Id. at col. 27, l. 29 to col. 28, l. 27 (emphasis added).Claims 2 and 3 depend from claim 1 and further limitthe hybridization ratio to greater than about twenty--five

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63 U.S.P.Q.2D (BNA) 1609

and fifty, respectively. Id. at col. 2, ll. 27--30. Claim 4 isdirected to the three deposited sequences (referenced bytheir accession numbers) and variants thereof as follows:

4. The composition of claim 1 wherein said nucleotidesequences are selected from the group consisting of:

a. the Neisseria gonorroheae [sic] DNA insert of ATCC53409, ATCC 53410 and ATCC 53411, and discrete nu-cleotide subsequences thereof,

b. mutated discrete nucleotide sequences of any of theforegoing inserts [**8] that are within said hybridizationratio and subsequences thereof; and

c. mixtures thereof.

Id. at col. 28, ll. 31--39. Claim 5 is directed to an assayfor detection of N. gonorrhoeae using the composition ofclaim 1. Id. at ll. 40--46. Claim 6 further limits the methodof claim 5 to the nucleotide sequences that Enzo deposited(i.e., those in claim 4) and variants thereof. Id. at ll. 47--56.

Enzo sued the defendants for infringement of the'659patent, and the defendants moved for summary judgmentthat the claims were invalid for failure to meet the writ-ten description requirement of35 U.S.C. § 112,P 1. Thedistrict court, in oral remarks from the bench, grantedthat motion. Tr. of Hr'g at 42,Enzo Biochem, Inc. v. Gen--Probe, Inc., 2001 U.S. Dist. LEXIS 23792 (S.D.N.Y. 2001).It concluded that the claimed composition of matter wasdefined only by its biological activity or function, viz., theability to hybridize to N. gonorrhoeae in a ratio of betterthan about five with respect to N. meningitidis, which itwas held was insufficient to satisfy the § 112, P 1 require-ment set forth in this court's holdings inRegents of theUniversity of California v. Eli Lilly & Co., 119 F.3d 1559,43 U.S.P.Q.2D (BNA) 1398 (Fed. Cir. 1997),[**9] Fiersv. Revel, 984 F.2d 1164, 25 U.S.P.Q.2D (BNA) 1601 (Fed.Cir. 1993), and Amgen, Inc. v. Chugai PharmaceuticalCo., 927 F.2d 1200, 18 U.S.P.Q.2D (BNA) 1016 (Fed.Cir. 1991).Tr. of Hr'g at 28. The court rejected Enzo'sargument that the reference in the specification to thedeposits of biological materials in a public depository in-herently disclosed that the inventors were in possessionof the claimed sequences. Id. at 35. It distinguished thiscourt's precedents concerning deposits as relating to theenablement requirement of § 112, P 1. Id. at 38--40. Enzoappealed to this court; we have jurisdiction pursuant to28 U.S.C. § 1295(a)(1).

DISCUSSION

[HN1] Summary judgment is appropriate when thereis no genuine issue of material fact and the moving partyis entitled to judgment as a matter of law. Fed. R. Civ.P. 56(c);Anderson v. Liberty Lobby, Inc., 477 U.S. 242,

247--48, [*1323] 91 L. Ed. 2d 202, 106 S. Ct. 2505(1986). [HN2] On motion for summary judgment, thecourt views the evidence and any disputed factual issues inthe light most favorable to the party opposing the motion.Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475U.S. 574, 587, 89 L. Ed. 2d 538, 106 S. Ct. 1348 (1986).[**10] [HN3] A patent is presumed to be valid,35 U.S.C.§ 282(1994), and this presumption can be overcome onlyby facts supported by clear and convincing evidence tothe contrary, see, e.g.,WMS Gaming, Inc. v. Int'l GameTech., 184 F.3d 1339, 1355, 51 U.S.P.Q.2D (BNA) 1385,1396--97 (Fed. Cir. 1999).Compliance with the writtendescription requirement is a question of fact.Vas--CathInc. v. Mahurkar, 935 F.2d 1555, 1563, 19 U.S.P.Q.2D(BNA) 1111, 1116 (Fed. Cir. 1991).

Enzo argues that the testimony of its expert, Dr.Wetmer, raised a genuine factual issue whether the refer-ence to the deposits inherently described the claimed nu-cleotide sequences. Enzo also argues that its description ofthe binding affinity of the claimed nucleotide sequencessatisfies the requirement set forth in the Guidelines forExamination of Patent Applications Under the35 U.S.C.112,P 1 "Written Description" Requirement,66 Fed. Reg.1099(Jan. 5, 2001) ("Guidelines"). Enzo asserts that thecourt erred in not evaluating the patentability of the claimsseparately, pointing out that claims 4 and 6 are directed tothe three deposited [**11] sequences and variations andmixtures thereof. Enzo further asserts that the claims perse meet the written description requirement because theyappear in ipsis verbis in the written description. Enzo alsoargues that this court's articulation of the written descrip-tion requirement for genetic material in Eli Lilly shouldnot apply to this case because Enzo reduced the inventionto practice and deposited the derived biological materials,thereby demonstrating its "possession" of the invention.

The defendants respond that the district court prop-erly granted summary judgment because the patent de-scribed the claimed nucleotide sequences only by theirfunction, which they state is insufficient to meet the re-quirements of § 112, P 1 as a matter of law, even as to thenarrower claims directed to the deposited materials. Thedefendants also assert that Dr. Wetmur's opinion that thedeposited genetic materials could have been sequenceddid not cure the actual failure of the inventors to identifythem by some distinguishing characteristic, such as theirstructure. Moreover, the defendants point out that claims4 and 6, which are directed to the deposited materials,each cover [**12] a broad genus of nucleic acids. Thedefendants also urge that in ipsis verbis support for theclaims in the specification does not per se establish com-pliance with the written description requirement. Finally,the defendants assert that the district court did not err in itsdetermination that Enzo's "possession" of three nucleotide

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sequences that it reduced to practice and deposited never-theless did not satisfy the written description requirementof § 112, P 1.

The written description requirement of [HN4] § 112,P 1 is set forth as follows:

The specification shall contain a written description of theinvention, and of the manner and process of making andusing it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains orwith which it is most nearly connected, to make and usethe same, and shall set forth the best mode contemplatedby the inventor of carrying out his invention.[*1324]

35 U.S.C. § 112,P 1 (1994) (emphasis added). [HN5]We have interpreted that section as requiring a "writtendescription" of an invention separate from enablement.Vas--Cath, 935 F.2d at 1563, 19 U.S.P.Q.2D (BNA) at1117 [**13] (recognizing the severability of the "writ-ten description" and "enablement" provisions of § 112, P1). Compliance with the written description requirementis essentially a fact--based inquiry that will "necessarilyvary depending on the nature of the invention claimed."Id. (citing In re DiLeone, 58 C.C.P.A. 925, 436 F.2d 1404,1405, 168 U.S.P.Q. (BNA) 592, 593 (CCPA 1971)).Wehave also previously considered [HN6] the written de-scription requirement as applied to certain biotechnologypatents, in which a gene material has been defined only bya statement of function or result, and have held that sucha statement alone did not adequately describe the claimedinvention. Eli Lilly, 119 F.3d at 1568, 43 U.S.P.Q.2D(BNA) at 1406.In Eli Lilly, we concluded that a claim to amicroorganism containing a human insulin cDNA was notadequately described by a statement that the invention in-cluded human insulin cDNA.Id. at 1567, 43 U.S.P.Q.2D(BNA) at 1405.The recitation of the term human insulincDNA conveyed no distinguishing information about theidentity of the claimed DNA sequence, such as its relevantstructural or physical characteristics. Id. We stated that[**14] [HN7] an adequate written description of geneticmaterial "'requires a precise definition, such as by struc-ture, formula, chemical name, or physical properties,' nota mere wish or plan for obtaining the claimed chemicalinvention," and that none of those descriptions appearedin that patent.Id. at 1566, 43 U.S.P.Q.2D (BNA) at 1404(quotingFiers, 984 F.2d at 1171, 25 U.S.P.Q.2D (BNA) at1606).The specification in the Eli Lilly case thus did notshow that the inventors had possession of human insulincDNA.

It is not correct, however, that all functional descrip-tions of genetic material fail to meet the written de-scription requirement. The PTO has issued Guidelinesgoverning its internal practice for addressing that issue.

The Guidelines, like the Manual of Patent ExaminingProcedure ("MPEP"), are not binding on this court, butmay be given judicial notice to the extent they do not con-flict with the statute. SeeMolins PLC v. Textron, Inc., 48F.3d 1172, 1180 n.10, 33 U.S.P.Q.2D (BNA) 1823, 1828n.10 (Fed. Cir. 1995).In its Guidelines, the PTO has de-termined that the written description requirement can bemet by "showing that an invention is complete by disclo-sure [**15] of sufficiently detailed, relevant identifyingcharacteristics . . . i.e., complete or partial structure, otherphysical and/or chemical properties, functional charac-teristics when coupled with a known or disclosed corre-lation between function and structure, or some combina-tion of such characteristics." Guidelines,66 Fed. Reg. at1106(emphasis added). For example, the PTO would findcompliance with § 112, P 1, for a claim to an "isolatedantibody capable of binding to antigen X," notwithstand-ing the functional definition of the antibody, in light of"the well defined structural characteristics for the fiveclasses of antibody, the functional characteristics of anti-body binding, and the fact that the antibody technologyis well developed and mature." Synopsis of Applicationof Written Description Guidelines, at 60, avail-able at http://www.uspto.gov/web/patents/guides.htm("Application of Guidelines"). Thus, under theGuidelines, the written description requirement would bemet for all of the claims of the'659 patent if the func-tional characteristic of preferential binding to N. gonor-rhoeae over N. meningitidis were coupled with a disclosed[**16] correlation between that [*1325] function and astructure that is sufficiently known or disclosed. We arepersuaded by the Guidelines on this point and adopt thePTO's applicable standard for determining compliancewith the written description requirement.

Applying those principles, we first inquire whetherEnzo's deposits of the claimed nucleotide sequences ofclaims 4 and 6 may constitute an adequate description ofthose sequences. Secondly, we will consider whether thedescription requirement is met for all of the claims on thebasis of the functional ability of the claimed nucleotidesequences to hybridize to strains of N. gonorrhoeae thatare accessible by deposit.

As to the first question, Enzo asserts that the claimedsequences are inherently described by reference to de-posits of three sequences that are within the scope of itsclaims. Whether reference to a deposit of a nucleotidesequence may adequately describe that sequence is an is-sue of first impression in this court. In light of the historyof biological deposits for patent purposes, the goals ofthe patent law, and the practical difficulties of describingunique biological materials in a written description, wehold that [**17] [HN8] reference in the specification toa deposit in a public depository, which makes its contents

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accessible to the public when it is not otherwise availablein written form, constitutes an adequate description of thedeposited material sufficient to comply with the writtendescription requirement of § 112, P 1.

The practice of depositing biological material aroseprimarily to satisfy the enablement requirement of § 112,P 1. For example, in In re Argoudelis, the patent appli-cation claimed antibiotic compounds that were producedby a microorganism.58 C.C.P.A. 769, 434 F.2d 1390,1390, 168 U.S.P.Q. (BNA) 99, 100 (CCPA 1970).The ap-plicants deposited the microorganism because they couldnot "sufficiently disclose by written word how to obtainthe microorganism starting material from nature."434F.2d at 1392, 168 U.S.P.Q. (BNA) at 102.By making thebiological material accessible to the public, they enabledthe public to make and use the claimed antibiotics.434F.2d at 1393, 168 U.S.P.Q. (BNA) at 102--03.In Amgen,we noted the relevance of deposit practice to satisfactionof the enablement requirement but rejected the defen-dants' argument that a deposit was necessary in that caseto satisfy the [**18] best mode requirement of § 112, P1. See927 F.2d at 1210, 18 U.S.P.Q.2D (BNA) at 1024;see alsoIn re Lundak, 773 F.2d 1216, 1217, 227 U.S.P.Q.(BNA) 90, 92 (Fed. Cir. 1985)(discussing deposit prac-tice primarily in relation to an enablement rejection andnoting that "an accession number and deposit date addnothing to the written description of the invention" in thecontext of proven availability of a cell line prior to filingdate).

Recognizing the importance of biological deposits topatent practice, the PTO has promulgated rules to addressthe procedural requirements relating to such deposits,but it has declined to expressly correlate substantive re-quirements relating to deposits with particular statutoryrequirements. See Deposit of Biological Materials forPatent Purposes,53 Fed. Reg. 39,420, 39,425(Oct. 6,1988) (notice of proposed rules) (codified at 37 C.F.R.Part 1) ("The rules are not intended to address which re-quirements of35 U.S.C. 112may be met by the makingof deposits."). The Office does offer guidance, however,in determining when a deposit may be necessary, such as"where the invention involves a biological [**19] mate-rial and words alone cannot sufficiently describe [*1326]how to make and use the invention in a reproducible man-ner." MPEP § 2402 (8th ed. Aug. 2001). The PTO has alsoissued a regulation stating [HN9] when a deposit is notnecessary, i.e., "if it is known and readily available to thepublic or can be made or isolated without undue experi-mentation."37 C.F.R. § 1.802(b)(2001). Inventions thatcannot reasonably be enabled by a description in writ-ten form in the specification, but that otherwise meet therequirements for patent protection, may be described insurrogate form by a deposit that is incorporated by ref-

erence into the specification. While deposit in a publicdepository most often has pertained to satisfaction of theenablement requirement, we have concluded that refer-ence in the specification to a deposit may also satisfy thewritten description requirement with respect to a claimedmaterial.

In this case, Enzo's deposits were incorporated by ref-erence in the specification. A person of skill in the art,reading the accession numbers in the patent specification,can obtain the claimed sequences from the ATCC depos-itory by following the appropriate techniques [**20] toexcise the nucleotide sequences from the deposited or-ganisms containing those sequences.'659patent, col. 13,ll. 27--36. The sequences are thus accessible from the dis-closure in the specification. Although the structures ofthose sequences, i.e., the exact nucleotide base pairs, arenot expressly set forth in the specification, those struc-tures may not have been reasonably obtainable and in anyevent were not known to Enzo when it filed its applicationin 1986. See'659 patent, col. 3, ll. 40--46 (noting severetime constraints in sequencing DNA). We therefore agreewith Enzo that reference in the specification to depositsof nucleotide sequences describe those sequences suffi-ciently to the public for purposes of meeting the writtendescription requirement.

As the defendants point out, however, Enzo's claims 4and 6 are not limited to the deposited sequences. Claim 4is directed to nucleotide sequences that are selected fromthe group consisting of the three deposited sequences,"discrete nucleotide subsequences thereof . . . mutated dis-crete nucleotide sequences of any of the foregoing in-serts that are within said hybridization ratio and subse-quences thereof[,] and [**21] . . . mixtures thereof."'659patent, col. 28, ll. 31--39. Claim 6 is also similarly di-rected to the three deposited sequences and subsequencesand mutated variations thereof. Id. at ll. 47--56. The spec-ification defines a subsequence non--specifically as a nu-cleotide sequence "greater than about 12 nucleotides."'659patent, col. 3, ll. 29--30. As the deposited sequencesare about 850, 850, and 1300 nucleotides long, id. atcol. 13, ll. 47--49, there are at least hundreds of subse-quences of the deposited sequences, an unknown numberof which might also meet the claimed hybridization ratio.Moreover, Enzo's expert, Dr. Wetmur, stated that "astro-nomical" numbers of mutated variations of the depositedsequences also fall within the scope of those claims, andthat such broad claim scope is necessary to adequatelyprotect Enzo's invention from copyists who could other-wise make a minor change to the sequence and therebyavoid infringement while still exploiting the benefits ofEnzo's invention. The defendants assert that such breadthis fatal to the adequacy of the written description. Onthe other hand, because the deposited sequences are de-

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scribed by virtue of a reference to their [**22] havingbeen deposited, it may well be that various subsequences,[*1327] mutations, and mixtures of those sequences arealso described to one of skill in the art. We regard thatquestion as an issue of fact that is best resolved on re-mand. n2 Because the district court's grant of summaryjudgment was based on its conclusion that Enzo's depositscould not satisfy the written description requirement as amatter of law, we reverse the district court's grant of sum-mary judgment that claims 4 and 6 are invalid for failure tomeet the written description requirement. On remand, thecourt should determine whether a person of skill in theart would glean from the written description, includinginformation obtainable from the deposits of the claimedsequences, subsequences, mutated variants, and mixturessufficient to demonstrate possession of the generic scopeof the claims.

n2 We do not address the issue whether thebreadth of the claim may implicate other validityissues, such as enablement. Only written descrip-tion is before us.

[**23]

We next address the question whether the composi-tions of the broader genus claims 1--3 and 5 are suffi-ciently described to meet the requirements of § 112, P1, on the basis of Enzo's deposits of three sequences. Ifthose sequences are representative of the scope of thegenus claims, i.e., if they indicate that the patentee hasinvented species sufficient to constitute the genera, theymay be representative of the scope of those claims. SeeIn re Smythe, 480 F.2d 1376, 1383, 178 U.S.P.Q. (BNA)279, 284--85 (CCPA 1973)(discussing circumstances inwhich a species may be representative of and thereforedescriptive of genus claims). Because the district courtconcluded that the deposited sequences were not them-selves described, it did not determine whether that de-scription was representative of the genera in those claims.Such determination should be made on remand.

When we addressed a similar issue in Eli Lilly, wedetermined that a disclosure of the sequence of rat cDNAwas not descriptive of the broader invention consistingof mammalian and vertebrate cDNA, although it wasa species falling within the scope of those claims.EliLilly, 119 F.3d at 1567--68, 43 U.S.P.Q.2D (BNA) at 1405.[**24] In Eli Lilly, the specification and generic claimsto all cDNAs encoding for vertebrate or mammalian in-sulin did not describe the claimed genus because they didnot set forth any common features possessed by membersof the genus that distinguished them from others.Id. at1568, 43 U.S.P.Q.2D (BNA) at 1405.Nor did the specifi-cation describe a sufficient number of species within the

very broad genus to indicate that the inventors had madea generic invention, i.e., that they had possession of thebreadth of the genus, as opposed to merely one or twosuch species. Id. The PTO has included a hypotheticalexample based on the facts of Eli Lilly in its Synopsis ofApplication of Written Description Guidelines in whichthe description requirement is not met. See Applicationof Guidelines, Example 17, at 61--64. The PTO has alsoprovided a contrasting example of genus claims to nucleicacids based on their hybridization properties, and has de-termined that such claims may be adequately described ifthey hybridize under highly stringent conditions to knownsequences because such conditions dictate that all specieswithin the genus will be structurally similar. See [**25]id., Example 9, at 35--37. Whether the disclosure providedby the three deposits in this case, coupled with the skill ofthe art, describes the genera of claims 1--3 and 5 is a factquestion the district court did not address. On remand,the district court should determine, [*1328] consistentlywith the precedent of this court and the PTO's Guidelines,whether one skilled in the art would consider the subjectmatter of claims 1--3 and 5 to be adequately described,recognizing the significance of the deposits and the scopeof the claims.

Enzo argues that all of the claims are adequately de-scribed on another basis, viz., by means of the disclosedcorrelation of the function of hybridization with the bac-terial DNA. In its petition for rehearing, Enzo states asattorney argument that "the description and claiming ofbiological materials by their affinity to other materialsthat are clearly identified in the specification and claims(the particular deposited strains of N. gonorrhoeae and N.meningitidis) inherently specifies structure, and is routinein this field." Claim 1 sets forth the deposit numbers of sixstrains of N. gonorrhoeae to which the claimed nucleotidesequences [**26] preferentially hybridize, as well as thedeposit numbers of six strains of N. meningitidis thatare thereby distinguished. Again, as with the claimed nu-cleotide sequences, the sequences of the genomic DNAof those bacteria are not disclosed, perhaps because suchsequencing would have been unduly burdensome at thetime of Enzo's invention.'659 patent, col. 3, ll. 40--46(noting that it would take 3,000 scientists one month tosequence the genome of one strain of N. gonorrhoeae andone strain of N. meningitidis). However, as those bacteriawere deposited, their bacterial genome is accessible and,under our holding today, they are adequately described inthe specification by their accession numbers. Because theclaimed nucleotide sequences preferentially bind to thegenomic DNA of the deposited strains of N. gonorrhoeaeand have a complementary structural relationship withthat DNA, those sequences, under the PTO Guidelines,may also be adequately described. Although the patent

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specification lacks description of the location along thebacterial DNA to which the claimed sequences bind, Enzohas at least raised a genuine issue of material fact as towhether a reasonable [**27] fact--finder could concludethat the claimed sequences are described by their abilityto hybridize to structures that, while not explicitly se-quenced, are accessible to the public. Such hybridizationto disclosed organisms may meet the PTO's Guidelinesstating that functional claiming is permissible when theclaimed material hybridizes to a disclosed substrate. Thatis a fact question. We therefore conclude that the dis-trict court erred in granting summary judgment that theclaims are invalid for failure to meet the written descrip-tion requirement. On remand, the court should considerwhether one of skill in the art would find the genericallyclaimed sequences described on the basis of Enzo's dis-closure of the hybridization function and an accessiblestructure, consistent with the PTO Guidelines. If so, thewritten description requirement would be met.

We next address Enzo's additional argument that thewritten description requirement for the generic claims isnecessarily met as a matter of law because the claim lan-guage appears in ipsis verbis in the specification. We donot agree. Even if a claim is supported by the specifi-cation, the language of the specification, to the extent[**28] possible, must describe the claimed invention sothat one skilled in the art can recognize what is claimed.The appearance of mere indistinct words in a specifica-tion or a claim, even an original claim, does not nec-essarily satisfy that requirement. One may consider ex-amples [*1329] from the chemical arts. A descriptionof an anti--inflammatory steroid, i.e., a steroid (a genericstructural term) described even in terms of its functionof lessening inflammation of tissues fails to distinguishany steroid from others having the same activity or func-tion. Similarly, the expression "an antibiotic penicillin"fails to distinguish a particular penicillin molecule fromothers possessing the same activity. [HN10] A descrip-tion of what a material does, rather than of what it is,usually does not suffice.Eli Lilly, 119 F.3d at 1568, 43U.S.P.Q.2D (BNA) at 1406.The disclosure must allowone skilled in the art to visualize or recognize the identityof the subject matter purportedly described. Id.

In Eli Lilly, we were faced with a set of facts inwhich [HN11] the words of the claim alone did not con-vey an adequate description of the invention.Id. at 1567,43 U.S.P.Q.2D (BNA) at 1405.[**29] In such a situa-tion, regardless whether the claim appears in the originalspecification and is thus supported by the specificationas of the filing date, § 112, P 1 is not necessarily met.See Guidelines at 1100 (noting Eli Lilly's clarification ofthe "original claim" doctrine in situations in which thename of the claimed material does not convey sufficient

identifying information). If a purported description of aninvention does not meet the requirements of the statute,the fact that it appears as an original claim or in the spec-ification does not save it. A claim does not become moredescriptive by its repetition, or its longevity.

Inasmuch as § 112, P 1 requires such description, weare not persuaded by Enzo's argument that, because thespecification indicated that Enzo "possessed" the claimedinvention by reducing three sequences within the scopeof the claims to practice, Enzo necessarily described theinvention. It is true that in Vas--Cath, we stated: [HN12]"The purpose of the 'written description' requirement isbroader than to merely explain how to 'make and use';the applicant must also convey with reasonable clarity tothose skilled in the art that, as of the filing [**30] datesought, he or she was in possession of the invention."Vas--Cath, 935 F.2d at 1563--64, 19 U.S.P.Q.2D (BNA)at 1117.That portion of the opinion in Vas--Cath, how-ever, merely states a purpose of the written descriptionrequirement, viz., to ensure that the applicant had posses-sion of the invention as of the desired filing date. It doesnot state that possession alone is always sufficient to meetthat requirement. Furthermore, in Lockwood v. AmericanAirlines, Inc., we rejected Lockwood's argument that "allthat is necessary to satisfy the description requirement isto show that one is 'in possession' of the invention."107F.3d 1565, 1572, 41 U.S.P.Q.2D (BNA) 1961, 1966 (Fed.Cir. 1997).Rather, we clarified that [HN13] the writtendescription requirement is satisfied by the patentee's dis-closure of "such descriptive means as words, structures,figures, diagrams, formulas, etc., that fully set forth theclaimed invention." Id.

[HN14] The articulation of the written description re-quirement in terms of "possession" is especially meaning-ful when a patentee is claiming entitlement to an earlierfiling date under35 U.S.C. §§ 119or 120, in interferences[**31] in which the issue is whether a count is supportedby the specification of one or more of the parties, and inex parte applications in which a claim at issue was filedsubsequent to the application. SeeVas--Cath, 935 F.2d at1560, 19 U.S.P.Q.2D (BNA) at 1114(describing situationsin which the written description requirement [*1330]may arise);Ralston Purina Co. v. Far--Mar--Co, Inc., 772F.2d 1570, 1575, 227 U.S.P.Q. (BNA) 177, 179 (Fed. Cir.1985) (noting, in the context of claiming entitlement tothe priority date of an earlier application, that the writtendescription requirement is met if "the disclosure of theapplication relied upon reasonably conveys to the artisanthat the inventor had possession at that time of the laterclaimed subject matter"). [HN15] Application of the writ-ten description requirement, however, is not subsumed bythe "possession" inquiry. A showing of "possession" isancillary to the statutory mandate that "the specification

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shall contain a written description of the invention," andthat requirement is not met if, despite a showing of pos-session, the specification does not adequately describethe claimed invention. After all, as indicated above, one[**32] can show possession of an invention by means ofan affidavit or declaration during prosecution, as one doesin an interference or when one files an affidavit under37C.F.R. § 1.131to antedate a reference. However, such ashowing of possession alone does not cure the lack ofa written description in the specification, as required bystatute.

Similarly, we conclude that [HN16] proof of a reduc-tion to practice, absent an adequate description in thespecification of what is reduced to practice, does notserve to describe or identify the invention for purposesof § 112, P 1. As with "possession," proof of a reductionto practice may show priority of invention or allow oneto antedate a reference, but it does not by itself providea written description in the patent specification. We arethus not persuaded by Enzo's argument, relying on thePTO's Guidelines, that its disclosure of an actual reduc-tion to practice is an important "safe haven" by whichit has demonstrated compliance with the description re-quirement. [HN17] The Guidelines state:

Actual reduction to practice may be crucial in the rela-tively rare instances where the level of knowledge andlevel of skill [**33] are such that those of skill in the artcannot describe a composition structurally, or specify aprocess of making a composition by naming components

and combining steps, in such a way as to distinguish thecomposition with particularity from all others.

Guidelines,66 Fed. Reg. at 1101.[HN18] For biologicalinventions, for which providing a description in writtenform is not practicable, one may nevertheless comply withthe written description requirement by publicly deposit-ing the biological material, as we have held today. Thatcompliance is grounded on the fact of the deposit andthe accession number in the specification, not because areduction to practice has occurred. Such description isthe quid pro quo of the patent system; the public mustreceive meaningful disclosure in exchange for being ex-cluded from practicing the invention for a limited periodof time.

CONCLUSION

For the foregoing reasons, we conclude that the dis-trict court erred in granting summary judgment that theclaims of the'659 patent are invalid for failure to meetthe written description requirement of § 112, P 1. Whilethe district judge clearly understood and correctly applied[**34] this court's existing precedent, we nevertheless re-verse because this case has taken us into new territory andwe have held, as a matter of first impression, that referencein a patent specification to a deposit of genetic materialmay suffice to describe that material. We therefore remandfor further resolution consistent with this opinion.

REVERSED and REMANDED

2 of 3 DOCUMENTS



01--1230


42 Fed. Appx. 439; 2002 U.S. App. LEXIS 14412; 63 U.S.P.Q.2D (BNA) 1618

July 15, 2002, Decided

NOTICE:[**1] RULES OF THE FEDERAL CIRCUITCOURT OF APPEALS MAY LIMIT CITATION TOUNPUBLISHED OPINIONS. PLEASE REFER TOTHE RULES OF THE UNITED STATES COURT OFAPPEALS FOR THIS CIRCUIT.

PRIOR HISTORY:Enzo Biochem, Inc. v. Gen--Probe Inc., 285 F.3d 1013,2002 U.S. App. LEXIS 5642, 62 U.S.P.Q.2D (BNA) 1289(Fed. Cir. 2002)

JUDGES:LOURIE, Circuit Judge, with whom NEWMAN, CircuitJudge, joins, concurring in the court's decision not to hearthe case en banc. NEWMAN, Circuit Judge, concurringin the denial of rehearing en banc. DYK, Circuit Judge,concurring in the court's decision not to hear the case enbanc. RADER, Circuit Judge, with whom GAJARSA andLINN, Circuit Judges, join, dissenting from the court's de-cision not to hear the case en banc. LINN, Circuit Judge,with whom RADER and GAJARSA, Circuit Judges, join,dissenting from the court's decision not to the hear the caseen banc.

OPINION:

[*439]

ON PETITION FOR REHEARING

ORDER

A petition for rehearing was filed by the plaintiff--appellant, and a response thereto was invited by the courtand filed by the defendants--appellees. The United StatesPatent and Trademark Office and Fish & Richardson P.C.filed briefs as amici curiae. This matter was referred firstto the merits panel that heard this appeal, which vacatedits earlier decision and prepared a revised decision forissuance. Thereafter, [**2] at the request of a non--

panel judge, an en banc poll was conducted concerningwhether the appeal ought to be heard en banc. The pollfailed. Circuit Judges RADER, GAJARSA, and LINNwould have heard the appeal en banc.

Upon consideration thereof,

IT IS ORDERED THAT:

The petition for rehearing is granted as set forth in thepanel opinion issued concurrently with this order.

[*440] LOURIE, Circuit Judge, with whomNEWMAN, Circuit Judge, joins, filed an opinion con-curring in the court's decision not to hear the case enbanc.

NEWMAN, Circuit Judge, filed an opinion concur-ring in that decision.

DYK, Circuit Judge, filed an opinion concurring inthat decision.

RADER, Circuit Judge, with whom GAJARSA andLINN, Circuit Judges, join, filed an opinion dissentingfrom that decision.

LINN, Circuit Judge, with whom RADER andGAJARSA, Circuit Judges, join, filed an opinion dissent-ing from that decision.

July 15, 2002

Date

CONCURBY:LOURIE; NEWMAN; DYK

CONCUR:

LOURIE, Circuit Judge, with whom NEWMAN, CircuitJudge, joins, concurring in the court's decision not to hearthe case en banc.

I agree that the court correctly declined to hear [**3]

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this case en banc.

First, it is important to note that the earlier panelmajority, in response to the petition for rehearing, has re-versed its earlier decision. Taking the case en banc wouldtherefore delay and hence frustrate the remand of the casesolely for the purpose of revising written description law.That law is sound and does not need revision, at least asproposed by the dissents.

The dissenters believe that the written description re-quirement is simply a requirement for enablement. Withall due respect, that is incorrect. The complete statutoryprovision is as follows:

The specification shall contain a written description of theinvention, and of the manner and process of making andusing it, in such full, clear, concise, and exact terms as toenable any person skilled in the art to which it pertains orwith which it is most nearly connected, to make and usethe same, and shall set forth the best mode contemplatedby the inventor of carrying out his invention.

35 U.S.C. § 112,P 1 (1994) (emphasis added). I readthe statute so as to give effect to its language. The statutestates that the invention must be described. [**4] Thatis basic patent law, the quid pro quo for the grant of apatent. Judge Rader notes that historically the written de-scription requirement served a purpose when claims werenot required. While that may be correct, when the statutebegan requiring claims, it was not amended to delete therequirement; note the comma between the description re-quirement and the enablement provision, and the "and"that follows the comma. Judge Rich, whom Judge Radercites, was in fact one of the earliest interpreters of thestatute as having separate enablement and written de-scription requirements.In re Ruschig, 54 C.C.P.A. 1551,379 F.2d 990, 995--996, 154 U.S.P.Q. (BNA) 118, 123(C.C.P.A. 1967); Vas--Cath Inc. v. Mahurkar, 935 F.2d1555, 1563, 19 U.S.P.Q.2D (BNA) 1111, 1117 (Fed. Cir.1991).The basic requirement to describe one's inventionwas recently emphasized as an independent patentabilityrequirement by the Supreme Court in Festo:

In addition, the patent application must describe, enable,and set forth the best mode of carrying out the inven-tion. § 112 (1994 ed.). These latter requirements mustbe satisfied before issuance of the patent, for exclusivepatent [**5] rights are given in exchange for disclosingthe invention to the public. See Bonito Boats, Inc. v.Thunder Craft Boats, Inc., 489 U.S. 141, 150--151, 103 L.Ed. 2d 118, 109 S. Ct. 971.What is claimed by the patentapplication must be the same as what is disclosed in thespecification; otherwise the patent should not issue.

[*441] Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki

Co., 535 U.S. 722, 152 L. Ed. 2d 944, 122 S. Ct. 1831,1840 (2002)(emphases added).

It is said that applying the written description require-ment outside of the priority context was novel until severalyears ago. Maybe so, maybe not; certainly such a holdingwas not precluded by statute or precedent. New interpre-tations of old statutes in light of new fact situations occurall the time. I believe these issues have arisen in recentyears for the same reason that more doctrine of equiva-lents issues are in the courts, viz., because perceptionsthat patents are stronger tempt patent owners to try toassert their patents beyond the original intentions of theinventors and their attorney. That is why the issues are be-ing raised and that is why we have to decide them. Claimsare now being asserted to cover what was not reasonablydescribed in the patent. [**6]

Moreover, the dissenters would limit the requirement,to the extent that they credit the written description por-tion of the statute as being a separate requirement at all, topriority issues. The statute does not say "a written descrip-tion of the invention for purposes of policing priority."While it has arisen primarily in cases involving priorityissues, Congress has not so limited the statute, and wehave failed to so limit it as well. As for the lack of earliercases on this issue, it regularly happens in adjudicationthat issues do not arise until counsel raise them, and, whenthat occurs, courts are then required to decide them. Evennow, a written description issue should not arise unless apatentee seeks to have his claims interpreted to includesubject matter that he has not adequately disclosed inhis patent. Although it is true that the written descriptionrequirement has been applied rigorously in some recentcases, I do not believe that any of those cases were decidedwrongly. The losing patents (or applications) involved didnot adequately disclose what was claimed: a particularratio of variables,Purdue Pharma L.P. v. Faulding Inc.,230 F.3d 1320, 1327, 56 U.S.P.Q.2D (BNA) 1481, 1487(Fed. Cir. 2000);[**7] a sofa with controls other than onthe console,Gentry Gallery, Inc. v. Berkline Corp., 134F.3d 1473, 1480, 45 U.S.P.Q.2D (BNA) 1498, 1503--1504(Fed. Cir. 1998);a cup other than a conical cup,Tronzov. Biomet, Inc., 156 F.3d 1154, 1159--60, 47 U.S.P.Q.2D(BNA) 1829, 1833--34 (Fed. Cir. 1998);human insulincDNA, Regents of the Univ. of Cal. v. Eli Lilly & Co., 119F.3d 1559, 1567, 43 U.S.P.Q.2D (BNA) 1398, 1405 (Fed.Cir. 1997); or beta--interferon,Fiers v. Revel, 984 F.2d1164, 1171, 25 U.S.P.Q.2D (BNA) 1601, 1606 (Fed. Cir.1993).Interpretation of written description as this courthas done furthers the goal of the law to have claims com-mensurate in scope with what has been disclosed to thepublic.

I believe that the dissenters miss the point in seeing


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this case as involving an original claim or in ipsis ver-bis issue. There is no question that an original claim ispart of the specification. That was the question answeredin the affirmative byIn re Gardner, 480 F.2d 879, 178U.S.P.Q. (BNA) 149 (C.C.P.A. 1973),in which the CCPAfound compliance with the written description require-ment over the objection of the PTO Commissioner, whoargued [**8] that an original claim should not be con-sidered part of the written description unless the specifi-cation was amended to contain the subject matter of theoriginal claim. However, the question here is whether thedisclosure, as an original claim, or in the specification, *adequately [*442] describes the invention. It is incor-rect that the mere appearance of vague claim language inan original claim or as part of the specification necessar-ily satisfies the written description requirement or showspossession of a generic invention.

Not only are we not entitled to ignore the statutory writ-ten description requirement, but our court has not. Earliercases also upheld a separate written description require-ment, and the fact that they may have pertained to prioritydisputes does not vitiate their basic requirement to dis-close one's invention. Section 112, paragraph 1, does notlimit itself to priority disputes. I thus believe it is incor-rect, as Judge Rader states, that our cases have limited thewritten description/new matter doctrine to priority pro-tection. Opinions explain the decisions on the issues thatcome before them on the facts presented; those caseshave not expressly limited [**9] the written descriptionrequirement to priority issues, and in fact they emphasizethat the requirement arises in a "variety of situations."Inre Wright, 866 F.2d 422, 424, 9 U.S.P.Q.2D (BNA) 1649,1651 (Fed. Cir. 1989).Any language seemingly appearingto limit the language to priority issues does so because itaddresses a priority issue that was before it. Other broadlanguage is not binding holding on different facts andraising different issues. Courts do not, or should not, pur-port to write treatises on the law, outlining all aspects of astatute that comes before them. They decide issues raisedin light of the decision being reviewed.

* Enzo's claim 1 is actually not an originalclaim. It was amended to include language appear-ing in the original specification and it thus appearsin ipsis verbis in the specification.

Moreover, even if written description is related to andoverlaps with "new matter," so what? One can fail tomeet the requirements of the statute in more than onemanner, and [**10] in any event the case cited as equat-ing those two requirements in fact distinguishes §§ 112and 132 as concerning: (1) claims not supported by thedisclosure; and (2) the prohibition of new matter to the

disclosure, respectively.In re Rasmussen, 650 F.2d 1212,1214--15, 211 U.S.P.Q. (BNA) 323, 326 (C.C.P.A. 1981).Rasmussen states that "the proper basis for rejection of aclaim amended to recite elements thought to be withoutsupport in the original disclosure, therefore, is § 112, firstparagraph, not § 132." Id.

In addition, we do not "elevate 'possession' to theposture of a statutory test of patentability." Rather, theopinion refines the "possession" test for circumstancessuch as these in which the inventors showed possessionof a species of the invention by reference to a deposit,but may not have described what else within the scope ofthe claims they had possession of. While "possession" isa relevant factor in determining whether an invention isdescribed, it is only a criterion for satisfying the statutorywritten description requirement. Showing possession isnot necessarily equivalent to providing a written descrip-tion.

Judge Rader's dissenting opinion [**11] cites au-thors who disapprove of our decisions. While views ofknowledgeable and objective commentators are surely ofinterest to this court, we should not interpret the law basedon taking polls of discontented writers. Our commissionis to apply the law to the facts and attempt to explain thereasons for our decisions. Critical articles may be writtenby those who have lost a case, or those who are skilled in aparticular technology or not, or those who have little prac-tical experience or who are seasoned experts. While JudgeRader cites articles critical of Lilly, others are favorable.Not surprisingly, an author from Eli Lilly took a positiveview of the case. See Mark J. Stewart (patent associateat Eli Lilly), Note, The Written Description Requirementof 35 U.S.C. § 112(1): The Standard AfterRegents ofthe University [*443] of California v. Eli Lilly & Co.,32 Ind. L. Rev. 537, 563 (1999)("The holding in Lillyactually avoided a disaster that would have crippled thebiotechnology industry. The enormous amount of timeand money companies spend to study DNA and proteinvariants, to clone homologous genes and protein familymembers, [**12] and to mine databases would no longerbe justified had the court found the written description in'4,652,525 adequate.").

Other authors support a robust written description re-quirement and point out the benefits of such a requirementto the public. See, e.g., Scott A. Chambers,"WrittenDescription" and Patent Examination Under the U.S.Patent and Trademark Office Guidelines, IP Litigator,Sept.--Oct. 2000, at 9, 10 ("Thus, the Federal Circuit'spresent interpretation of the written description require-ment maintains the vitality of the U.S. patent system andprovides disclosures that others can build on. By suggest-ing that disclosure of the structure or actual sequence of


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complex chemical entities may sometimes be required,the Federal Circuit may have advanced the goal of thepatent system to actually put the claimed invention into thehands of the public."); Margaret Sampson,The Evolutionof the Enablement and Written Description Requirementsunder 35 U.S.C. § 112 in the Area of Biotechnology,15 Berkeley Tech. L. J. 1233, 1260--61 (2000)("Withouta heightened written description requirement, inventorscould receive patent rights to [**13] sequences of whichthey have no knowledge, in organisms with which theyhave never worked. . . . Therefore, the Federal Circuit'sapproach to the written description requirement in thearea of biotechnology has prevented nucleotide sequenceclaims from becoming a Pandora's box that the patent lawis unable to control."). In any event, we decide cases asthey come to us, based on the arguments raised, the de-cisions below, the law, the facts, and our best efforts, notbased on occasional journal articles.

Since some of the cases implicated by this issue are inthe biotech field, I should point out that, among the prob-lems in comprehension of the issues in a biotech contextis that a functional description of DNA does not indicatewhich DNA has been invented. And simply acknowledg-ing the presence of a DNA that serves a particular func-tion, whose existence has been postulated since, perhaps,Mendel, plus a general process for finding it, is not a de-scription of the DNA. It is a research plan at best, anddoes not show "possession" of any invention.

Still, in terms of the more practical aspects of comply-ing with the statute, meeting the description requirementis the first [**14] task in drafting a patent application.Enabling one of skill in the art to make and use the in-vention is a separate requirement. To interpret the writtendescription requirement only as an enablement provisionis to let the tail wag the dog. Perhaps there is little dif-ference in electrical and mechanical inventions betweendescribing an invention and enabling one to make anduse it, but that is not true of chemical and chemical--likeinventions.

Enzo's patent claimed a genus of chemical--like mate-rials (a sequence of nucleic acids is of a chemical nature ----note the claims begin with "a composition"). Althoughone may envision a general concept, what one usuallydoes first in making or isolating a chemical or chemical--related invention is to obtain a specific material or mate-rials. One then broadens the concept to extend it as faras one envisions that other materials will have the sameutility and can be similarly made. That broadened con-cept becomes the genus in a patent application that is boththe broadest statement constituting a written description[*444] and usually claim 1. One then elaborates to fill in

the genus with representative examples of compounds orsubstances that fall within [**15] the genus. That is partof the written description needed to support the genericclaim. Then, one tells how to make the materials, andthen how to use them. That is enablement, separate inconcept from describing what the invention is. The ideathat there is no requirement in the statute to describe one'snew invention (aside from the fact that the language ofthe statute contains one) separate from the requirement toenable one to make and use it is not correct. Disclosureis the first role of a patent. One must first state what one'sinvention is. That is quite different from telling how tomake and use it.

Some commentators have had difficulty in under-standing how one may have enabled an invention, butnot described it. They believe they must coincide. Asan example of how the written description and enable-ment provisions differ in chemistry, however, one mayreadily have enabled the making of an invention, but stillnot have described it. For example, a propyl or butyl com-pound may be made by a process analogous to a disclosedmethyl compound, but, in the absence of a statement thatthe propyl and butyl compounds are part of the inven-tion, they have not been described [**16] and they arenot entitled to a patent (I make no implication here aboutcoverage under the doctrine of equivalents). SeeIn reDi Leone, 58 C.C.P.A. 925, 436 F.2d 1404, 1405 n.1, 168U.S.P.Q. (BNA) 592, 593 n.1 (C.C.P.A. 1971)("Considerthe case where the specification discusses only compoundA and contains no broadening language of any kind. Thismight very well enable one skilled in the art to make anduse compounds B and C; yet the class consisting of A, Band C has not been described."). This is surely part of therecent history of some biotechnology patents.

In sum, we have evolved a consistent body of lawover a number of years, based on the statute and basicprinciples of patent law. I see no reason to hear this caseen banc and rewrite the statute.

NEWMAN, Circuit Judge, concurring in the denial ofrehearingen banc.

I join Judge Lourie's statement, and write separatelyto emphasize my concern with the position of the dissentconcerning the law of written description. The descrip-tion of the invention has always been the foundation ofthe patent specification. It sets forth what has been in-vented, and sets boundaries of what can be claimed. Thetheory [**17] of the dissent that a description of the in-vention is not needed in order to support the claims, butserves only to antedate prior art or establish priority in aninterference, is a dramatic innovation in the theory andpractice of patents. It has never been the sole purposeof the description requirement, and negates not only the


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logic but also the history of patent practice. The dissent'scitation of cases in which the description of the inventionhas been relied on to antedate references and in inter-ference contests reinforces, not reduces, the role of thedescription of the invention in establishing what has beeninvented.

The dissent argues that the subject matter that is in-tended to be patented need not be described, as long as itis enabled. Undoubtedly, in many patents these require-ments are met by the same information content. And thespecial case of the biological deposit is a method of com-plying with the statutory requirements, as the panel nowconfirms; this expedient implements the statute for thisspecial subject matter, but does not change it. It is not[*445] the law that the description of the invention servesonly to establish priority, to be invoked only when priority[**18] is at issue. The invention that is covered by theclaims must be described as well as enabled, as the statutehas always required.

DYK, Circuit Judge, concurring in the court's decisionnot to hear the case en banc.

The opinions of Judges Newman, Lourie, Rader, andLinn concerning the denial of en banc rehearing raiseimportant and interesting questions, including questionsconcerning the correctness of our earlier decision inRegents of the University of California v. Eli Lilly &Co., 119 F.3d 1559, 43 U.S.P.Q.2D (BNA) 1398 (Fed.Cir. 1997),cert. denied,523 U.S. 1089 (1998),that maysomeday warrant the court's en banc attention. Given thepanel's decision on rehearing, remanding for further con-sideration by the district court, this is not the appropriateoccasion for en banc review. The court will also benefitfrom further percolation of these issues before they areaddressed by the full court.

DISSENTBY:RADER; LINN

DISSENT:

RADER, Circuit Judge, with whom GAJARSA andLINN, Circuit Judges, join, dissenting from the court'sdecision not to hear the case en banc.

The tortuous path of this case shows the perils ofignoring the [**19] statute and over thirty years of con-sistent written description case law n1. The first version ofthis opinion,Enzo Biochem, Inc. v. Gen--Probe, Inc., 285F.3d 1013, 62 U.S.P.Q.2D (BNA) 1289 (Fed. Cir. 2002),purported to invalidate a patent because the inventor hadnot shown "possession of the invention" for written de-scription. See,Vas--Cath Inc. v. Mahurkar, 935 F.2d 1555,1564, 19 U.S.P.Q.2D (BNA) 1111, 1117 (Fed. Cir. 1991).

As this court now acknowledges, an inventor can hardlyshow possession of an invention better than by depositingthe invention in an internationally recognized repository.This court corrects part of the mistake of Enzo I. Yetthe court still remands to the district court to reexaminethe written description requirement. Because the writtendescription requirement as created and applied for thirtyyears does not apply to this case, I would grant en bancreview and correct the rest of this court's misapplicationof the description requirement.

n1 An appendix at the close of this opinion willbriefly explicate all written description cases fromits creation in 1967 in the Court of Customs andPatent Appeals to the present. This appendix showsthat only two cases, this ENZO case and the 1997LILLY case have purported to apply the doctrineoutside its purpose and function.

[**20]

Statute

Because the greater mistake in this case is misappli-cation of this court's written description case law, thisopinion devotes only a few paragraphs to the statutory in-terpretation question. The United States' brief asamicuscuriae in support of rehearingen bancstates conciselythis Enzo opinion's disregard for the statute:

A straightforward reading of the text of section 112suggests that the test for an adequate written descriptionis whether it provides enough written information for oth-ers to make and use the invention. The statute providesthat the "specification shall contain a written descriptionof the invention . . . in such full, clear, concise, and exactterms as to enable any person skilled in the art . . . to makeand use the same."35 U.S.C. § 112P 1. Thus, an adequatewritten description assures that others can "make and use"the invention. n2

[*446] If it is possible to characterize disregard of statu-tory text as a secondary mistake, this case fits that classi-fication. The more important problem is disregard for thecase law that originated the written description require-ment and applied it for over thirty years. [**21]

n2 This court rejected the "straightforwardreading" of the statute in Vas--Cath because thewritten description (WD) doctrine was a prioritycontrol, not the general disclosure doctrine of en-ablement. See,Vas--Cath, 935 F.2d 1555.Withinthe proper purpose of WD, Vas--Cath makes sense.When applied outside the priority context as a gen-eral disclosure doctrine, however, WD cannot de-part from the enablement test without replacing it.


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Thus, the United States advocates application ofthe statutory standard of enablement.

Origin and History of the Written DescriptionRequirement

The words "written description" first appeared in thePatent Act of 1793. At that time, of course, patents didnot require claims but only a written description suffi-cient "to distinguish [the invention] from all other thingsbefore known or used." InEvans v. Eaton, 20 U.S. 356,5 L. Ed. 472 (1822),the Supreme Court construed thedescription language to require applicants to enable their[**22] inventions and to provide the notice function ofclaims:

[After enablement,] the other object of the specificationis to put the public in possession of what the party claimsas his own invention, so as to ascertain if he claims anything that is in common use, or is already known .. .

Id. at 433.In later enactments, this notice function wasassigned to claims, leaving enablement as the only pur-pose of the "written description" language. As noted in theUnited States' brief, the modern descendant of the 1793phrase still requires only a written description "in such.. . terms as to enable [the invention]."35 U.S.C. § 112.In J.E.M. Ag. Supply, the Supreme Court acknowledgedonly enablement as the disclosurequid pro quoof thePatent Act: "In addition [to novelty, utility, and nonob-viousness], to obtain a utility patent, a breeder must de-scribe the plant with sufficient specificity to enable othersto 'make and use' the invention after the patent term ex-pires."J.E.M. Ag. Supply, Inc. v. Pioneer Hi--Bred Int'l,Inc., 534 U.S. 124, 122 S. Ct. 593, 604, 151 L. Ed. 2d 508(2001).Reading the statute, [**23] the Supreme Courtcorrectly found no general disclosure requirement in title35 other than enablement. n3

n3 In Festo, the Supreme Court mentions a de-scription requirement separate from enablement.Festo Corp. v. Shoketsu Kogyo Kabushiki Co., 535U.S. 722, 152 L. Ed. 2d 944, 122 S. Ct. 1831, 1840(2002).This listing of doctrines, however, did notendorse any departure from this court's case law formore than thirty years.

Before 1967, this court's predecessor, the UnitedStates Court of Customs and Patent Appeals also didnot differentiate written description from enablement. In1966, that predecessor court wrote in detail about section112, paragraph 1, and found only two requirements----enablement (the A requirement under Judge Rich's termi-nology) and best mode (the B requirement).In re Gay,50 C.C.P.A. 725, 309 F.2d 769, 772, 135 U.S.P.Q. (BNA)

311, 315(CCPA, 1962).

In 1967, the Court of Customs and Patent Appealsfirst separated a new written description (WD) require-ment from the enablement [**24] requirement of § 112.The reason for this new judge--made doctrine needs someexplanation. Every patent system must have some provi-sion to prevent applicants from using the amendment pro-cess to update their disclosures (claims or specifications)during their pendency before the patent office. Otherwiseapplicants could add new matter to their disclosures anddate them back to their original filing date, thus defeatingan accurate [*447] accounting of the priority of inven-tion. Priority ---- always a vital issue in patent prosecutionprocedures ---- often determines entitlement to an inven-tion. Before 1967, the United States Patent Office andthe Court of Customs and Patent Appeals used a "newmatter" rejection to ensure that applicants did not up-date their disclosures after the original filing date of theapplication. This "new matter" rejection had a statutorybasis: "No amendment shall introduce new matter intothe disclosure of the invention."35 U.S.C. § 132.

In 1967, inIn re Ruschig, 54 C.C.P.A. 1551, 379 F.2d990, 154 U.S.P.Q. (BNA) 118 (CCPA 1967),this court'spredecessor created for the first time a new WD doctrineto enforce priority. In the context of [**25] a new claimadded "about a year after the present application wasfiled," the Ruschig court sought to determine "whether[the new] claim 13 is supported by the disclosure of ap-pellants' application."379 F.2d at 991.Rather than use §132, however, Ruschig assigned the role of policing prior-ity to § 112. As a technical matter, the Court of Customsand Patent Appeals distinguished between adding newmatter to the specification and adding new matter to theclaims. Under PTO practice, new matter in the claimswould draw a § 132 rejection of the claims; new matterin the specification would draw a § 132 objection to theaddition. The Ruschig court, for the first time, decidedto treat the objection alone as a § 132 matter. To dealwith new matter in the claims, the court calved a newWD doctrine out of the § 112 enablement requirement n4. As long as the new WD doctrine applied according toits original purpose as an identical twin of the § 132 newmatter doctrine, these technical distinctions were of littlepractical consequence.

n4 As a matter of integrity to the statute, theRuschig distinction has a major problem, namelythe language of § 132 embraces both new mat-ter rejections of amended claims and new matterobjections to amended specifications. Both claimsand the rest of the specification are part of the patent"disclosure" within the terms of § 132. See, e.g.,Inre Frey, 35 C.C.P.A. 970, 166 F.2d 572, 575, 77


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U.S.P.Q. (BNA) 116, 119 (CCPA 1948)("Certainlythe [claim] is a disclosure of itself."). Moreover im-plicit in the judicial creation of a new WD require-ment is the incorrect assumption that the PatentAct had no remedy for new matter in claims be-fore 1967. In fact, § 132 embraces both new matterrejections and objections.

[**26]

In any event, the WD doctrine, at its inception had avery clear function -- preventing new matter from creep-ing into claim amendments. Judge Rich, the author ofRuschig, often reiterated the purpose of WD. For instancein the case ofIn re Wertheim, 541 F.2d 257, 191 U.S.P.Q.(BNA) 90 (CCPA 1976),the Court of Customs and PatentAppeals confronted a priority issue:

The dispositive issue under this heading is whetherappellants' parent and Swiss applications comply with35U.S.C. § 112,first paragraph, including the descriptionrequirement, as to the subject matter of these claims. Ifthey do, these claims are entitled to the filing dates oftheparentapplication . . . . [A] right of foreignpriority inappellants' Swiss application will antedate Pfluger 1966and remove it as prior art against the claims.

Id. at 261(emphasis added). In resolving this question,Judge Rich stated again the purpose of WD: "The functionof the description requirement is to ensure that the inven-tor had possession, as of the filing date of the applicationrelied on, of the specific subject matterlater claimed byhim." Id. at 262[**27] (emphasis added). In sum, WDwas a new matter doctrine, a priority policeman.

Returning to the history of WD, after 1967, the PTOcontinued to use new matter rejections under § 132, butalso embraced [*448] the coterminous written descrip-tion analysis. Thus, for many years, the PTO rejectedpriority errors in claims under both § 132 and § 112.

In 1981, the Court of Customs and Patent Appealsnoted that the two rejections were interchangeable: "Thiscourt, has said that a rejection of an amended claimunder § 132 is equivalent to a rejection under § 112,first paragraph."In re Rasmussen, 650 F.2d 1212, 1214,211 U.S.P.Q. (BNA) 323, 325(CCPA, 1981) (emphasisadded). To avoid confusion between new matter rejec-tions and objections, the court chose to eliminate the §132/ § 112 rejections and to use § 112 for new matterrejections (claims): "The proper basis for rejection of aclaim amended to recite elements thought to be withoutsupport in the original disclosure, therefore, is § 112, firstparagraph, not § 132." Id. The purpose of the doctrinedid not change. As the sentence above states explicitly,the § 112 doctrine, like its corollary § 132, policed pri-ority, [**28] nothing more. At no time did either the

CCPA or the Federal Circuit purport to apply the equiva-lent new matter/written description rejections to originalclaims or other claims without priority problems. See,e.g.,In re Koller, 613 F.2d 819, 823, 204 U.S.P.Q. (BNA)702, 706 (CCPA 1980)("Original claims constitute theirown description.");In re Gardner, 475 F.2d 1389, 1391,177 U.S.P.Q. (BNA) 396, 397 (CCPA 1973)("Claim 2,which apparently was an original claim, in itself consti-tuted a description in the original disclosure . . . . Nothingmore is necessary for compliance with the descriptionrequirement . . . ."). WD, the equivalent of the statutorynew matter doctrine, simply has no application to claimswithout priority problems.

The Federal Circuit continued to follow this bindingprecedent. See, e.g.,Vas--Cath, 935 F.2d at 1560("Thequestion raised by these situations is most often phrasedas whether the application provides 'adequate support' forthe claim(s) at issue; it has also been analyzed in termsof 'new matter' under35 U.S.C. § 132."); In re Wright,866 F.2d 422, 424, 9 U.S.P.Q.2D (BNA) 1649, 1651 (Fed.Cir. 1989)[**29] ("When the scope of a claim has beenchanged by amendment in such a way as to justify anassertion that it is directed to adifferent inventionthanwas the original claim, it is proper to inquire whether thenewly claimed subject matter wasdescribedin the patentapplication when filed as the invention of the applicant.That is the essence of the so--called 'description require-ment' of § 112, first paragraph.") (emphases added); n5In re Kaslow, 707 F.2d 1366, 217 U.S.P.Q. (BNA) 1089(Fed. Cir. 1983).In fact, this Circuit's test for written de-scription required assessment of the specification to check"later claimed subject matter."Id. at 1375("The test fordetermining compliance with the written description re-quirement is whether the disclosure of the application asoriginally filed reasonably conveys to the artisan that theinventor had possession at that time of thelater claimedsubject matter, rather than the presence or absence of lit-eral support [*449] in the specification for the claimlanguage.") (emphasis added). In fact, this standard em-phasizes that WD does not examine the specification for"literal support" of the claim language unless [**30] pri-ority is in question. In any event, this Circuit did notapply WD to claims without priority problems becausethe doctrine had no purpose beyond policing priority. n6

n5 In Wright, Judge Rich mentions that WDarises in "a variety of situations." Id. Of course, thisobservation is an accurate description of the prior-ity issue. Priority arises in the context of a § 102(b)rejection, see, e.g.,In re Ruschig, 379 F.2d at 991,a § 119 issue, see, e.g.,In re Wertheim, 541 F.2dat 261,a § 120 issue, see, e.g.,Kennecott Corp. v.Kyocera Int'l., Inc., 835 F.2d 1419, 1421 (Fed. Cir.


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1987) ("The incorporation of the requirements ofsection 112 into section 120 ensures that the inven-tor had possession of the later--claimed inventionon the filing date of the earlier application."), and a§ 102(g) interference, see, e.g.,Fiers v. Revel, 984F.2d at 1169,to mention just a few of the variety ofsituations in which priority arises. This statementhardly justifies applying WD outside its purpose asa test for sufficiency of disclosure.

[**31]

n6 Again, the appendix at the close of this opin-ion shows that the Federal Circuit uniformly ap-plies WD to police priority. Only the LILLY andthis ENZO opinion purport to apply it as a generaldisclosure requirement in place of enablement.

The deviation from thirty years of precedent

In 1997, for the first time, this court purported toapply WD as a general disclosure doctrine in place ofenablement, rather than as a priority doctrine.Regents ofthe Univ. of Cal. v. Eli Lilly and Co., 119 F.3d 1559, 43U.S.P.Q.2D (BNA) 1398 (Fed. Cir. 1997).In Lilly, thiscourt found that the '4,652,525 patent specification doesnot provide a WD of human insulin cDNA despite thedisclosure of a general method of producing human in-sulin cDNA and a description of the human insulin A andB chain amino acid sequences that cDNA encodes.119F.3d at 1567.In the words of the court, "a descriptionthat does not render a claimed invention obvious does notsufficiently describe that invention for purposes of § 112,P 1." Id. At another point, the court stated: "An adequatewritten description [**32] of a DNA .. . 'requires a precisedefinition, such as by structure, formula, chemical name,or physical properties . . . .'"Id. at 1566(quotingFiers v.Revel, 984 F.2d 1164, 1171, 25 U.S.P.Q.2D (BNA) 1601,1606 (Fed. Cir. 1993)).In sum, the Lilly opinion doesnot test a later claim amendment against the specificationfor priority, but asserts a new free--standing disclosurerequirement in place of the statutory standard of enable-ment. Based on the absence of a nucleotide--by--nucleotiderecitation in the specification of the human insulin cDNA,the court determined that the applicant had not adequatelydescribed the invention. For the first time, this court pur-ported to apply WD without any priority question. But see,Kaslow, 707 F.2d at 1375("rather than the presence or ab-sence of literal support in the specification for the claimlanguage."). Even accepting that WD can be isolated as aseparate requirement from enablement in § 112, P 1, thewords "written description" hardly prescribe a standardthat requires nucleotide--by--nucleotide disclosure.

Under the correct written description test, one of skillin the art would have recognized [**33] that the '525

patent in Lilly had no new matter or priority problems.In terms of the statutory test for adequacy of disclosure,the patent disclosure undoubtedly warranted rejection forlack of enablement. Under the Wands test for enable-ment,858 F.2d 731, 8 U.S.P.Q.2D (BNA) 1400 (Fed. Cir.1988),the inventor certainly did not show one of skill inthe art how to make human insulin cDNA. n7 Moreoverthe patent claimed vertebrate insulin cDNA -- a categoryranging from fish to humans -- again claims whose scopefar exceeds the patent's enabling disclosures. In fact, the[*450] patent disclosure only revealed that the inventorhad enabled cloning of rat insulin. Instead of invalidatingunder the statutory test for adequacy of disclosure, i.e.,enablement, the Lilly court purported to create a new doc-trine for adequacy of disclosure that it labeled incorrectly"written description." As noted, from its creation throughthirty years of application, WD had never been a free--standing substitute for enablement.

n7 U.S. Pat. No.4,652,525, the patent at is-sue in Lilly, was filed in 1983, but claimed pri-ority to a parent filed in 1977. In 1977, biotech-nology was still in its infancy. In fact, the Maxamand Gilbert method of sequencing DNA was justpublished in 1977. Cloning in that era was, at aminimum, unpredictable and would have requiredvast amounts of experimentation to accomplish.Therefore, the patent's prophetic disclosure of hu-man insulin cDNA hardly enabled its productionas claimed. Instead of pursuing this obvious av-enue of rejection, the Federal Circuit reached outbeyond the statute and the case law to create a newgeneral disclosure test.

[**34]

Although it should not be necessary, a brief defenseof the statutory standard for adequate disclosure showsthe flaws of the new form of WD. Enablement alreadyrequires inventors to disclose how to make (reproduce,replicate, manufacture) and how to use the invention (bydefinition rendering it a "useful art"). Therefore, becausethe competitor can make the invention, it can then acquirethe DNA sequence or any other characteristic whenever itdesires. Meantime the competitor can use, exploit, com-mercialize (outside the patent term) or improve upon anddesign around (within the patent term) as much of theinvention as it cares to make. In other words, the statutorystandard for sufficiency of disclosure serves masterfullythe values of the patent system.

Even after Lilly, the Federal Circuit ---- in all otherWD cases before this Enzo case ---- applied priority prin-ciples, declining to assert the doctrine as a general test foradequacy of disclosure. See, e.g.,Union Oil Co. of Cal.


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v. Atlantic Richfield Co., 208 F.3d 989, 54 U.S.P.Q.2D(BNA) 1227 (Fed. Cir. 2000).One of those opinions ana-lyzes WD with particular care:

The written description [**35] requirement and its corol-lary, the new matter prohibition of35 U.S.C. § 132,bothserve to ensure that the patent applicant was in full pos-session of the claimed subject matter on the applicationfiling date. When the applicant adds a claim or otherwiseamends his specification after the original filing date, asBrandon did in this case, the new claims or other addedmaterial must find support in the original specification.

TurboCare Div. Of Demag Delaval TurbomachineryCorp. v. General Elec. Co., 264 F.3d 1111, 1118, 60U.S.P.Q.2D (BNA) 1017, 1022 (Fed. Cir. 2001).

In sum, the written description language has beenin the statute since 1870, yet only since 1967 has caselaw separated it from enablement. The separation itself isnot disruptive of the patent system, however, because thedoctrine operated solely to police priority. Indeed, withthe exception of Lilly and this Enzo case, this court andits predecessor have only applied the doctrine within thelimits of its origin as an "equivalent" or "corollary" of35U.S.C. § 132,the new matter section.

Enzo and written description

The record in this case shows [**36] that no priorityissues remain to invoke WD. The inventor in this caseamended the original claims in response to the examiner'srequest to place the selective hybridization steps in theclaims. Thus, the amendments were all narrowing --mean-ing the applicant added no new matter to the claims byamendment. Instead, the applicant copied material fromthe original specification into the original claims. By def-inition, this case presents no new matter or priority issuesrequiring application of the original WD doctrine. Theoriginal specification contained all of the subject mat-ter included in the inventor's claims. For this reason, thepanel misapplies § 112, P 1 by remanding on the ques-tion of WD. See, slip op. at 17 ("On remand, the courtshould consider whether one of skill in the art wouldfind the generically claimed sequences described on thebasis of Enzo's disclosure of the hybridization functionand an accessible structure, consistent with the [*451]PTO Guidelines. If so, the written description require-ment would be met."). If any § 112, P 1 questions remain,they are questions of the sufficiency of disclosure, an en-ablement question. Instead, the panel, relying on Lilly,[**37] advocates applying WD "regardless whether theclaim appears in the original specification and is thus sup-ported by the specification as of the filing date." Id. at 18.To the contrary, WD has no such application consistentwith the statute and the case law.

Why does this matter?

As both Lilly and this case show, the aberrant formof WD requires far more specific disclosure than enable-ment. n8 Because the Lilly application of § 112, P 1 re-quires a far more demanding disclosure, defendants willhave no need to invoke enablement, but will proceed di-rectly to the more demanding Lilly § 112, P 1 require-ments. Thus, the new breed of WD evident in Lilly andthis case threatens to further disrupt the patent systemby replacing enablement -- the statutory test for adequatedisclosure. See, Rai, Arti, "Intellectual Property Rights inBiotechnology: Addressing New Technology"34 WakeForest L. Rev. 827, 834--35(Fall, 1999) ("Thus in [ Lilly] . . . the CAFC broke new ground by applying the writtendescription requirement not only to later--filed claims butalso to claims filed in the original patent. . . . T]he Lillycourt used the written [**38] description requirement asa type of elevated enablement requirement."); Mueller,Janice M., "The Evolving Application of the WrittenDescription Requirement to Biotechnological Inventions"13 Berkeley Tech. L.J. 615, 617 (Spring 1998)("The Lillydecision establishes uniquely rigorous rules for the de-scription of biotechnological subject matter that signifi-cantly contort written description doctrine away from itshistoric origins and policy grounding. The Lilly court ele-vates written description to an effective 'super enablement'standard . . . .").

n8 "Conflicts in Federal Circuit Patent LawDecisions," The Federal Circuit Bar Journal, Vol.11, no. 3, p. 723, chronicles this circuit's primaryconflicts. Listed first as the leading conflict is "I.The Written Description Requirement of § 112,First Paragraph." Id. at 725--34. The article notes:"The Federal Circuit has not provided clear andconsistent rules for determining precisely what typeof disclosure is sufficient to comply with the § 112written description requirement." Id. at 725. Thearticle then notes three separate tests for measur-ing compliance with § 112, P 1. For instance, "thestrictest approach requires the written descriptionto delineate all of the claimed elements. " Id.

[**39]

Furthermore, the Supreme Court repeatedly cau-tioned against the disruption of the settled expectationsof the inventing community.Festo, 122 S. Ct. at 1841("The responsibility for changing [settled law] rests withCongress. . . . Fundamental alterations in these rules riskdestroying the legitimate expectations of inventors in theirproperty."). Lilly and now this case change the applicationof the WD test and "up the ante" for disclosure -- a situ-ation inventors might have addressed if they could have


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foreseen that this court would disrupt settled disclosureprinciples. At this point, however, those inventors haveno way to change patents that comply with enablementdisclosure, but not the stiffer demands of Lilly.

Replacement of enablement doctrines with an ill--defined general disclosure doctrine of WD imperils theintegrity of the patent system. Enablement, arguablythe most important patent doctrine after obviousness, hasmany important applications. Beyond mere adequacy ofdisclosure, it serves as the line of demarcation between thevisionary theorist (adds nothing to the useful arts) and thevisionary pioneer (contributes to the useful arts), [**40]see, e.g.,Gould v. Hellwarth, 472 F.2d 1383, 176 U.S.P.Q.(BNA) 515 [*452] (CCPA 1973),and also serves to limitclaim scope thus demarking the boundary between pio-neer inventions and patentable improvements, see, e.g.,In re Wright, 999 F.2d 1557 (Fed. Cir. 1993).The WDpossession test cannot perform these functions. ProfessorJanis explains that WD provides a blunt tool to measurethe sufficiency of disclosure:

Today, however the written description requirementenjoys a prominence wholly out of proportion to its hum-ble origins.

. . . .

Recent efforts to elaborate the 'possession' standardboth confirm the substantial redundancy of the enable-ment and written description requirements . . . .

. . . .

The written description requirement is a threat to the co-herence of disclosure doctrines . . . .

Janis, Mark D., "On Courts Herding Cats: Contendingwith the 'Written Description' Requirement (and OtherUnruly Patent Disclosure Doctrines)"2 Wash. U. J. L. &Pol'y 55, 60, 70, 83 (2000).

Professors Rai, Mueller, and Wegner, among others,agree with Professor Janis's assessment. Rai, Mueller,supra; Wegner, Harold [**41] C., "An Enzo White Paper:A New Judicial Standard for a Biotechnology 'WrittenDescription' Under35 U.S.C. § 112,P 1" 1 J. MarshallRev. Intell. Prop. L. 254, 263 (2002) (recognizing "theremay very well be problems with the scope of enablementin the facts of the Enzo case," but written descriptionwould not apply to "original claims.").

For biotech inventions, according to the Lilly stan-dard, § 112, P 1 requires a precise listing of the DNAsequence nucleotide--by--nucleotide. Enablement, on theother hand, requires that the specification show one ofskill in the art how to acquire that sequence on their own.As a test for biotech claims without priority issues, WD

may well jeopardize a sizeable percentage of claims filedbefore the Lilly departure in 1997. These patents had nonotice of a change in the statutory standard for disclo-sure. Moreover the Lilly/Enzo rule prejudices universityor small inventors who do not have the expensive andtime--consuming resources to process every new biotech-nological invention to extract its nucleotide sequence. See,Mueller, supra at 617 ("Lilly . . . will likely chill develop-ment."); Sampson, [**42] Margaret, "The Evolution ofthe Enablement and Written Description RequirementsUnder35 U.S.C. § 112in the Area of Biotechnology."15Berkeley Tech. L.J. 1233, 1262 (Fall 2000)("The primaryargument against the Federal Circuit's heightened writtendescription requirement for biotechnological invention isthat . . . it also 'reduces incentives to invest in innovation bydepriving potential patentees of the opportunity to fullybenefit from their research.'").

Saving the obvious for last, Lilly and this case reallycannot depart from decades of established case law on §112, P 1. Even the court's decision to issue this improvedversion of Enzo without correcting all the problems doesnot indicate any acceptance of written description as ageneral disclosure doctrine for all claims regardless of pri-ority issues. Lilly and this case are panel cases and cannotoverride the statute that makes enablement the generaldisclosure doctrine and the vast body of prior case lawlimiting WD to its original purpose. Sadly, however, thiscase will perpetuate the confusion.

Conclusion

Written description -- a part of the Patent Act [**43]since 1870 -- has taken on a life separate [*453] from itsstatutory context only since 1967. As long as WD appliedonly for the reasons that occasioned its judicial creation,it did not disrupt the rest of the Patent Act. Two recentcases, however, this case and the 1997 Lilly case, havepurported to create a new disclosure doctrine that sup-plants enablement. Although this court declines to takethis occasion to correct those dalliances, the origin andpurpose of both § 112, P 1 doctrines serve notice thatneither Lilly nor this case properly applies the otherwiseorderly disclosure doctrines.

APPENDIX

CCPA

1. In re Ruschig, 54 C.C.P.A. 1551, 379 F.2d 990(CCPA 1967)."These claims were under rejection by rea-son of one--year statutory bars which could be overcomeonly by reliance on the filing date of the presentparentapplication which gave rise to the question whether theapplication contained support for the claims."379 F.2d at991.


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I. In re Ahlbrecht, 58 C.C.P.A. 848, 435 F.2d 908(CCPA 1971)."The parties disagree as to whether the dis-closure in theearlier application is sufficient under thefirst paragraph of35 U.S.C. § 112[**44] to support theinvention claimed in claim 7."435 F.2d at 909.

3. Fields v. Conover, 58 C.C.P.A. 1366, 443 F.2d 1386(CCPA 1971)."Even when considered .. . it falls far short. . . of the 'full, clear, concise, and exact' written descriptionwhich we have said is necessary to supportsubsequentlyadded claims."443 F.2d at 1392.

4. In re Smith, 59 C.C.P.A. 1025, 458 F.2d 1389(CCPA 1972)."Appellant has no basis on which the dis-closure in the 1947 application may be treated as a de-scription of the subject matternowclaimed."458 F.2d at1394.

5. In re Gardner, 475 F.2d 1389 (CCPA 1973)."Claim2, which apparently was an original claim, in itself consti-tuted a description in the original disclosure equivalent inscope and identical in language to the total subject matternow being claimed."Id. at 1391.

6. In re Smith, 481 F.2d 910 (CCPA 1973)."Satisfaction of the description requirement insures thatsubject matter presented in the form of a claimsubsequentto the filing date of the application was sufficiently dis-closed at the time of filing so that prima [**45] facie dateof invention can fairly be held to be the filing date of theapplication. . . . The specification as originally filed mustconvey clearly to those skilled in the art the informationthat the applicant has invented the specific subject matterlater claimed."Id. at 914.

7. In re Mott, 539 F.2d 1291 (CCPA 1976)."Theissue under this heading is whether appellant's specifica-tion, construed in light of the knowledge of those skilledin this art, contains a written description of the subjectmatter of claims 42, 44, and 46." (Claims 42, 44 and 46were claims copied from the Taylor patent and put in theapplication byamendment.) Id. at 1296.

8. In re Wertheim, 541 F.2d 257 (CCPA 1976)."Thedispositive issue under this heading is whether appellants'parent and Swiss applications comply with35 U.S.C. §112, first paragraph, including the description require-ment, as to the subject matter of these claims. If they do,these claims are entitled to the filing dates of theparentapplication . . . . [A] right of foreignpriority in appellants'Swiss application will antedate [**46] Pfluger 1966 andremove it as prior art against the claims."Id. at 261."Thefunction of the description requirement is to ensure thatthe inventor had possession, as of the filing date of the ap-plication relied on, of the specific [*454] subject matterlater claimed by him."Id. at 262.

9. In re Blaser, 556 F.2d 534 (CCPA 1977)."Thefunction of the description requirement is to ensure thatthe inventor had possession, as of the filing date of theapplication relied on, of the specific subject matterlaterclaimed by him."Id. at 537(quotingIn re Wertheim, 541F.2d at 262).

10. In re Barker, 559 F.2d 588 (CCPA 1977)."Wecan find no indication in the specification or claims asoriginally filed that appellants invented the subject matternowclaimed."Id. at 593.

11. In re Driscoll, 562 F.2d 1245 (CCPA 1977)."Appellant does not dispute that the appealed claim isanticipated by the Belgian patent if the present appli-cation is not entitled to theearlier filing date of S.N.782,756. Consequently, the sole issue with respect to thisaspect [**47] of the appeal is whether the disclosure ofS.N. 782,756 described the subject matter of claim 13.In resolving this issue, we must view the disclosure oftheearlier filed application as would a person skilled inthe art and determine whether it reasonably conveys theinformation that as of the filing date thereof appellanthad possession of the class of 5--alkylsulfonyl--1, 3, 4--thiadiazole ureas defined in claim 13."Id. at 1248--49.

12. In re Edwards, 568 F.2d 1349 (CCPA 1978)."Thedispositive issue is whether appellants'parentapplication,serial No. 682,560, filed November 13, 1967, complieswith the written description requirement of35 U.S.C. §112, first paragraph, vis--a--vis the subject matter of theappealed claim; if it does, then the claim is entitled tothe filing date of theparentapplication under35 U.S.C. §120." Id. at 1351.

13. In re Herschler, 591 F.2d 693 (CCPA 1979)."Appellant concedes that the substance of this rejection isproper if the court finds either thegreat--grandparentap-plication lacks a written description of theinstant[**48]invention."Id. at 699.

14. In re Rasmussen, 650 F.2d 1212 (CCPA 1981)."The proper basis for rejection of a claim amended torecite elements thought to be without support in the orig-inal disclosure, therefore, is § 112, first paragraph, not §132. The latter section prohibits addition of new matterto the original disclosure. It is properly employed as abasis for objection to amendments to the abstract, spec-ifications, or drawings attempting to add new disclosureto that originally presented."Id. at 1214--15.

Federal Circuit

1. In re Kaslow, 707 F.2d 1366 (Fed. Cir. 1983)."The test for determining compliance with the writtendescription requirement is whether the disclosure of theapplication as originally filed reasonably conveys to the


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artisan that the inventor had possession at that time of thelater claimed subject matter, rather than the presence orabsence of literal support in the specification for the claimlanguage."Id. at 1375.

2. Ralston Purina Co. v. Far--Mar--Co., 772 F.2d 1570(Fed. Cir. 1985)."The test for sufficiency of support in aparentapplication [**49] is whether the disclosure of theapplication relied upon 'reasonably conveys to the artisanthat the inventor had possession at that time of thelaterclaimed subject matter.'"Id. at 1575.

3. Kennecott Corp. v. Kyocera Int'l., Inc., 835 F.2d1419 (Fed. Cir. 1987)."The incorporation of the require-ments of section 112 into section 120 ensures that theinventor had possession of thelater--claimed [*455] in-vention on the filing date of theearlier application."Id.at 1421.

4. Utter v. Hiraga, 845 F.2d 993 (Fed. Cir. 1988)."Hiraga's Japanese specification complies with the writtendescription requirement of Section 112 if 'the disclosureof the application as originally filed reasonably conveys tothe artisan that [Hiriga] had possession at that time of thelater claimed ['068 interference count] subject matter.'"Id. at 999.

5. Bigham v. Godtfredsen, 857 F.2d 1415 (Fed. Cir.1988)."This requirement applies topriority claims under35 U.S.C. § 119.. . . The test is whether the disclosure of'halogen,' exemplified by chloro, meets the requirements[**50] of § 112 as a written description of the bromoand iodo species in the context of the specific inventionat issue."Id. at 1417.

6. United States Steel Corp. v. Phillips PetroleumCo., 865 F.2d 1247 (Fed. Cir. 1989)."In the context ofsection 120, in this case, focusing on the filing date re-quires that the claim of the 851 patent be treated as thoughit were filed in 1953. Only if that claim would at that timehave been correctly rejected for lack of support in the1953 specification may the patentee be denied use of sec-tion 120 topredatethe intervening reference to the '300patent."Id. at 1251.

7. In re Wright, 866 F.2d 422 (Fed. Cir. 1989)."Whenthe scope of a claim has been changed by amendment insuch a way as to justify an assertion that it is directed to adifferent invention than was the original claim, it is properto inquire whether thenewlyclaimed subject matter wasdescribed in the patent application when filed as the inven-tion of the applicant. That is the essence of the so--called'description requirement' of § 112, first paragraph."Id. at424.

8. Chester v. Miller, 906 F.2d 1574 (Fed. Cir. 1990).[**51] "The EIC simply found that the '4,309,280 refer-

ence (parent) did not support the '122 application claimsbecause as to them it failed to meet the written descriptionrequirement."Id. at 1577.

9. Vas--Cath Inc. v. Mahurkar, 935 F.2d 1555 (Fed.Cir. 1991)."The purpose and applicability of the 'writtendescription' requirement . . . insure[] that subject matterpresented in the form of a claimsubsequentto the filingdate of the application was sufficiently disclosed at thetime of filing so that the prima facie date of invention canfairly be held to be the filing date of the application."Id.at 1562.

10. In re Hayes Microcomputer Products, Inc., 982F.2d 1527 (Fed. Cir. 1992)."The test for sufficiency ofsupport in aparentapplication is whether the disclosureof the application relied upon 'reasonably conveys to theartisan that the inventor had possession at that time of thelater claimed subject matter.'"Id. at 1532.

11. Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993)."Revel bears the burden of proving entitlement to the ben-efit of hisearlier--filed Israeli [**52] application date. . . .Revel must prove that his application meets the require-ments of35 U.S.C. § 112,first paragraph."Id. at 1169.

12. Mendenhall v. Cedarapids, 5 F.3d 1557 (Fed. Cir.1993)."Mr. Mendenhall himself testified that he did nothave any invention directed to introducing virgin aggre-gate and RAP as specified in the '31,904 claims untilDecember 1977, and there is no description of that in-vention in the parent or grandparent applications. . . . Apatentee cannot obtain the benefit of the filing date of anearlier application where the claims in issue could nothave been made in theearlier application."Id. at 1565--66.

13. Eiselstein v. Frank, 52 F.3d 1035 (Fed. Cir. 1995)."In order to determine [*456] whether a prior applicationmeets the 'written description' requirement with respectto later--filed claims, the prior application . . . . The testis whether the disclosure of the application relied uponreasonably conveys to a person skilled in the art that theinventor had possession of the claimed subject matter atthe time of theearlier filing date."Id. at 1038--39.[**53]

14. In re Alton, 76 F.3d 1168 (Fed. Cir. 1996)."Theadequate written description requirement . . . serves 'to en-sure that the inventor had possession, as of the filing dateof the application relied on, of the specific subject matterlater claimed by him'."Id. at 1172.

15. Kolmes v. World Fibers Corp., 107 F.3d 1534(Fed. Cir. 1997)."The question raised here is whether theclaimsaddedby the preliminary amendment to the 1992continuationapplication find adequate support in the 1990application sufficient to meet the description requirement


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of section 112, P 1."Id. at 1539.

16. Lockwood v. American Airlines, Inc., 107 F.3d1565 (Fed. Cir. 1997)."[A] prior application itself mustdescribe an invention, and do so in sufficient detail thatone skilled in the art can clearly conclude that the inven-tor invented the claimed invention as of the filing datesought."Id. at 1572.

After LILLY

1. Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d1473 (Fed. Cir. 1998)."Accordingly, his original disclo-sure serves to limit the permissible breadth [**54] of hislater--drafted claims."Id. at 1479.

2. Tronzo v. Biomet, Inc., 156 F.3d 1154 (Fed. Cir.1998)."For a claim in alater--filed application to be en-titled to the filing date of anearlier application under35U.S.C. sec. 120,theearlier application must comply withthe written description requirement of35 U.S.C. section112,P 1." Id. at 1158.

3. Union Oil Co, of Cal. v. Atlantic Richfield Co., 208F.3d 989 (Fed. Cir. 2000)."However, neither the PatentAct nor the case law of this court requires such detaileddisclosure. . . . Rather the Patent Act and this court's caselaw require only sufficient description to show one of skillin the refining art that the inventor possessed the claimedinvention at the time of filing."Id. at 997.

4. Reiffin v. Microsoft Corp., 214 F.3d 1342 (Fed. Cir.2000)."In accordance with § 120, claims to subject matterin a later--filed application not supported by an ancestorapplication in terms of §112 P 1are not invalidated; theysimply do not receive the benefit [**55] of theearlierapplication's filing date."Reiffin 214 F.3d at 1346.

5. Lampi Corp. v. American Power Products, Inc., 228F.3d 1365 (Fed. Cir. 2000)."For a claim in alater--filedapplication to be entitled to the filing date of anearlierapplication under35 U.S.C. 120,the earlier applicationmust comply with the requirement of35 U.S.C. § 112,P1." Id. at 1377."The requirement is met if 'the disclosureof the application relied upon reasonably conveys to theartisan that the inventor had possession at that time of thelater claimed subject matter.'"Id. at 1378.

6. Purdue Pharma L.P. v. Faulding, Inc., 230 F.3d1320 (Fed. Cir. 2000)."We conclude that the districtcourt did not commit clear error in finding that noth-ing in the '688 application 'necessarily' . . . described thelater claimed subject matter of the '5,672,360 patent."Id.at 1327.

7. TurboCare Div. Of Demag DelavalTurbomachinery Corp. v. General Elec. Co., 264 F.3d1111 (Fed. Cir. 2001)."The [*457] written description

requirement and its corollary, the new matter [**56]prohibition of35 U.S.C. § 132,both serve to ensure thatthe patent applicant was in full possession of the claimedsubject matter on the application filing date. Whenthe applicant adds a claim or otherwise amends hisspecification after the original filing date, as Brandon didin this case, the new claims or other added material mustfind support in the original specification."Id. at 1118.

LINN, Circuit Judge, with whom RADER andGAJARSA, Circuit Judges, join, dissenting from thecourt's decision not to the hear the case en banc.

I am in agreement with much of the panel's reasoningin the revised opinion, but part company with the panel'streatment of written description and enablement issues,most notably in the text dealing with the in ipsis verbisissue.

With all due respect, the panel opinion in my viewconflates and perpetuates the confusion our precedent hasengendered between written description as a separate re-quirement ("possession of the invention")----an issue rel-evant to priority----and enablement----an issue relevant tothe sufficiency of the disclosure. The notion of havingto show "possession of the invention" [**57] was dis-cussed inVas--Cath Inc. v. Mahurkar, 935 F.2d 1555, 19U.S.P.Q.2D (BNA) 1111 (Fed. Cir. 1991)and other casesfrom our court as a convenient way to measure or testentitlement of later filed claims to an earlier priority date.It was not and should not be a test for sufficiency of dis-closure, per se. It should have no place in and does notaid in the disposition of cases where the claims in ques-tion are part of the original disclosure. In those cases,entitlement to the filing date is inherent in that the claimsthemselves----having been filed as part of the original ap-plication----provide their own written description.

35 U.S.C. § 112requires a written description of theinvention, but the measure of the sufficiency of that writ-ten description in meeting the conditions of patentabilityin paragraph 1 of that statute, either by reference to amicroorganism deposit or in terms in ipsis verbis with thelanguage of the claims, should depend solely on whetherit enables any person skilled in the art to which the in-vention pertains to make and use the claimed invention.Where priority is not an issue, as in the present case, thefocus once a written [**58] description has been foundshould be on whether the description meets the enable-ment requirement. Satisfaction of the "possession of theinvention" test simply is not relevant.

The question presented by35 U.S.C. § 112,paragraph1, is not, "Does the written description disclose what theinvention is, or does it merely describe what it does?" Thequestion is, "Does the written description describe the in-


63 U.S.P.Q.2D (BNA) 1618

vention recited and described in the claims----themselvespart of the specification----in terms that are sufficient toenable one of skill in the art to make and use the claimedinvention?" That is the mandate of the statute and is all ourprecedent, prior toRegents of the University of Californiav. Eli Lilly & Co., 119 F.3d 1559, 43 U.S.P.Q.2D (BNA)1398 (Fed. Cir. 1997)and the present case, demand. Fororiginal claims, where priority is not an issue, the notionof possession of the invention is not germane, the claimitself evidencing possession of the invention as of the fil-ing date. In the panel opinion, the discussion of the inipsis verbis issue properly addresses enablement issuesbut does so in words not of enablement but of "possessionof the [**59] invention." This conflates the two unrelatedissues, elevates "possession" to the posture of a statutorytest of patentability----which it is not----and fosters furtherconfusion in what is already a confusing area of our prece-dent.

[*458] The U.S. Patent and Trademark Office("PTO") aptly states the reason why this case shouldbe taken en banc: "although this Court has addressedthe 'written description' requirement of section 112 on anumber of occasions, its decisions have not taken a clearand uniform position regarding the purpose and meaningof the requirement." PTO amicus brief at 4.

This is an area of law that is of significant importanceto the biotech industry and affects how patent applications

are drafted, prosecuted and will be enforced in this andother areas of emerging technology. When patent attor-neys set out to write patent applications, they do so for aneducated audience----those skilled in the art----and attemptto describe the invention in a way that enables those ofordinary skill to make and use the invention as claimed.Before the decision in Lilly, the practicing bar had ac-cepted and found workable the notion elucidated in ourprecedent that § 112 requires a written [**60] descrip-tion sufficient to enable one of ordinary skill in the artto make and use the claimed invention----i.e., enablement.Lilly changed the landscape and engendered the debatethe panel opinion in this case perpetuates.

Some have praised Lilly for maintaining the integrityof patent disclosures and for curbing patent filings for in-ventions that have not yet been made but are just nascentideas. Others have been sharply critical of Lilly. The de-bate is well framed by the panel opinion and the contem-poraneous dissent of Judge Rader. Those opinions high-light the uncertainty this issue raises in how inventions areprotected, in how the PTO discharges its responsibilities,and in how business is conducted in emerging fields oflaw. These uncertainties will be left unresolved until weclarify this en banc. The issue is important, is ripe for usto consider, and deserves to be clarified, one way or theother. For these reasons, I respectfully dissent from thecourt's declining to consider this case en banc.

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