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Introduction.........................................................................................................2Foundations of the U.S. Patent System.............................................................2Origins of the Patent System.............................................................................2Forms of Patent Protection................................................................................2Other Forms of IP Protection............................................................................2

Patent Eligibility..................................................................................................3Processes...........................................................................................................3Composition of Matter – Biotechnology...........................................................4Methods of Medical Treatment.........................................................................4

Utility....................................................................................................................4General Principles.............................................................................................4Utility in Chemistry & Biotechnology..............................................................4Utility Reqt at the Federal Circuit.....................................................................5

Anticipation..........................................................................................................5Statutory Bars......................................................................................................6

Applicant Activities – § 102(b).........................................................................6Of a Device....................................................................................................6Of a Process...................................................................................................6

Third Party Activities – § 102(b)......................................................................7Patents, Printed Publications, & “In this Country” – §§ 102(a) & 102(b)........7Abandonment – § 102(c)...................................................................................8Delayed U.S. Filing – § 102(d).........................................................................8

Novelty: Prior Invention.....................................................................................8Prior Invention under § 102(a)..........................................................................8Elements of “Invention” Under § 102(g)..........................................................8Patent Award to the Second Inventor................................................................9Disclosure in the U.S. Patent Applications § 102(e).......................................101st to File vs. 1st to Invent.................................................................................10

Nonobviousness..................................................................................................10Historical Standard of Invention.....................................................................10Modern Standard of Nonobviousness.............................................................10

Prior Art for Nonobviousness..........................................................................11Analogous Arts................................................................................................11

Patent Specification: Objective Disclosure.....................................................11Enablement......................................................................................................11“Written Description” – Proscription on New Matter.....................................12

Patent Specification: Best Mode......................................................................13Claims.................................................................................................................13

U.S. Peripheral Claiming Technique...............................................................13Patent Claim Format........................................................................................13Claim Definitiveness.......................................................................................13

Prosecution.........................................................................................................13Overview of Patent Prosecution......................................................................14Inventorship.....................................................................................................14Inequitable Conduct........................................................................................14Double Patenting.............................................................................................15

Post-Grant Procedures.....................................................................................15Reexamination.................................................................................................15

Infringement......................................................................................................15Literal Infringement........................................................................................15Doctrine of Equivalents...................................................................................16Limits on DoE.................................................................................................16Experimental Use............................................................................................17Indirect Infringement.......................................................................................18Process Patents................................................................................................18

Additional Defenses...........................................................................................18Laches & Estoppel..........................................................................................18

Remedies............................................................................................................19Injunctions.......................................................................................................19Damages..........................................................................................................19Enhanced Damages & Attorney Fees..............................................................20Marking...........................................................................................................20

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Patent Law Outline

IntroductionFoundations of the U.S. Patent System3-8

Bonito Boats v. Thunder Craft Boats 489 U.S. 141 (1989) [p.3] (Analysis: ) 35 U.S.C. § 101: Protection is offered to "[w]hoever invents or discovers any new and useful process, machine, manufacture,

or composition of matter, or any new and useful improvement thereof." 35 U.S.C. § 171: Protection available for "any new, original and ornamental design for an article of manufacture." The design

must present an aesthetically pleasing appearance that is not dictated by function alone, and must satisfy the other criteria of patentability.

35 U.S.C. §§ 102: Novelty requirement. Patentable unless the invention: (a) was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention; or (b) was patented or de-scribed in a printed publication in this or a foreign country or in public use or on sale in this country more than one year prior to the date of application for patent in the U.S. (a) & (b) work together to deny patentability to public knowledge. Monopolizing such information not socially useful, &

would injure the public by removing existing knowledge from public use. 35 U.S.C. § 103: Innovation must not be anticipated by the prior art in the field. Even if "novel", it is not patentable if antici-

pated as “the work of the skillful mechanic, not that of the inventor.” Requirements: novelty, nonobviousness, and utility. (Disclosure + best mode) (right to exclude).

Origins of the Patent System8-18

Jefferson's letter to Isaac McPherson. TJ rejected a natural-rights theory in intellectual property rights. Social & economic ra-tionale of the patent system. Patent was a reward for new knowledge. Not to be freely given.

Forms of Patent Protection18-26

Other Forms of IP Protection40-57

(p.40) Trademarks. The determination of whether marker qualifies for trademark protection depends in part upon its classification as generic descriptive suggestive or arbitrary. Generic terms: the ordinary name for the sort of product such as bread or sugar & can never received trademark protection; Descriptive marks: Ordinarily & naturally used to characterize a product. They may not be protected unless they have ac-

quired a certain level of distinctiveness, also known as secondary meaning. Examples: 1) Vision center for optical clinics, or 2) a name that indicates the products desirable characteristics such as Honey Baytown.

Suggestive marks: Inherently distinctive and therefore are subject to protection without the need to prove secondary meaning. Examples: Orange crushing for orange flavored soft drinks; skin visible; Camel cigarettes; Coined words like Kodak. Trade-mark protection can never extend to the functional features of a product.

Rationale is to prevent a monopoly in useful design features.

(p.41) Copyrights. Copyright may extend to any work of authorship. Examples: literary musical dramatic choreographic graphic audiovisual and architectural works sound recordings. Protectable as soon as their fixed in any tangible medium of expression. Must be original. Minimal amount of creative authorship. Cannot copyright and abstract idea, only the expression of that particu-lar idea. Copyright rights: exclusive right to make copies of the protected working & distributing to the public: derivative works such as translations or a screenplay adaptation; the right to display and perform the protected work publicly.

Restrictions: Fair use: allows the unauthorized use of copyrighted works in such contexts as educational activities, literary and so-cial criticism.

Patent Law Outline 4/9/2023, 5:07 PM, Page 6 of 24(p.43) Trade Secrets. Protects secret valuable business information for misappropriation by others, as long as the information is valuable and maintained as a secret. Misappropriation occurs when it has been obtained through the abuse of a confidential rela-tionship were improper means of their acquisition. The chief alternative to the patent system. May be used to protect subject mat-ter that is unpatentable.

Rationale for Trade secrets law: Treated as intellectual property, creating a proprietary interest just like a copyright patent or market. Insuring proper conduct. Whether the accused misappropriation or acquired the information in a fair and ethical matter.

Trade secret law encourages industry actors to develop valuable information by protecting them from improper acquisition by oth-ers. Liability for trade secret misappropriation discourages people from engaging in activities that do not create wealth but merely redistribute wealth for one person to another.

Patent Eligibility57-133

35 U.S.C. § 101: Useful arts ≡ 1) process; 2) machine; 3) manufacture; 4) composition of matter Process = series of acts performed upon subject matter to produce a given result Machine = any apparatus Composition of matter = synthesized chemical compounds & composite articles Article of manufacture = broad terms to capture almost any useful technology

Processes60-100

(p.86) Note 3: En Banc Review: In re Apappat, 33 F.3d 1526: Patent protection for computer-related inventions. Diehr: 3 cate-gories not protected: 1) Laws of nature; 2) Natural Phenomena; 3) Abstract ideas. Synthesizing Diehr, Flook, & Benson Supreme Court never intended to create an overly broad 4th category of subject matter excluded from § 101. Certain types of math-ematical subject matter, standing alone, represents nothing more than abstract ideas until reduced to some type of practical applica-tion.

After Alappat, every software invention can overcome patent eligibility problems if claimed in terms of its interchangeable hard-ware elements.

Gottschalk v. Benson 409 U.S. 63 (1972) [p.60] (Analysis: ) “Algorithm” ≡ Procedure for solving a given type of mathematical problem. The present claims are an algorithm – a general-

ized formulation for programs to solve mathematical problems of converting one form of numerical representation to another. Longstanding rule: “An idea of itself is not patentable.” Phenomena of nature, though just discovered, mental processes, and

abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work. (63b) Transformation and reduction of an article "to a different state or thing" is the clue to the patentability of a process

claim that does not include particular machines. (65t-m) See (p.96) Note 2: State Street rejection of FWA test rejection of Benson.

Diamond v. Diehr 450 U.S. 175 (1981) [p.68] (Analysis: ) 35 U.S.C. § 101: any new & useful process, machine, manufacture, or composition of matter, or improvement thereof Includes physical & chemical process for (raw material different state or thing). Detailed step-by-step method. Using equation / computer OK. Excludes: Ideas, laws of nature, natural phenomena, and abstract ideas. Examples: new min-

eral; new plant found in the wild; relativity; gravity. Reserved exclusively to none. Consider claims as a whole.

Applying a mathematical formula in a protectible process satisfies the requirements. Even if one or more process steps may not, in isolation, be novel or independently eligible for patent, irrelevant to

whether the claims as a whole recite eligible subject matter. Novelty is the combination.

State St. Bank & Trust Co. v. Signature Fin. Group 149 F.3d 1368 (Fed. Cir. 1998) [p.88] (Analysis: ) ISSUE: Whether business methods are a statutory subject matter under § 101. Patented invention: System that allows administrator to monitor & record the financial info flow; make all necessary calcula-

tions.

Patent Law Outline 4/9/2023, 5:07 PM, Page 7 of 24 “Means” + function is read pursuant to § 112, ¶ 6, as inclusive of the "equivalents" of the structures disclosed in the written

description portion of the specification. (91b) Judicially-created exceptions to statutory subject matter. 1) "mathematical algorithm"; 2) "business method"; 3) abstract

ideas; 4) laws of nature. (91b-92t) "Mathematical Algorithm" Exception (92b)

Not patentable subject matter to the extent that they are merely abstract ideas. (Diehr; Flook; Gottschalk v. Benson) (92b) Unpatentable : Merely abstract ideas constituting disembodied concepts or truths that are not "useful." Patentable: an algo-

rithm that is applied in a "useful" way. Example: Alappat – data transformed to produce a smooth waveform display on a rasterizer monitor was a practical application of an abstract idea; Smooth waveform ≡ “useful, concrete & tangible re-sult.”

Held: Transformation of data, representing discrete dollar amounts, by a machine w/ math calculations into a final share price ≡ a practical application of a math algorithm. The “useful, concrete & tangible result” ≡ Final share price momentar-ily fixed for recording.

Composition of Matter – Biotechnology100-119

Diamond v. Chakrabarty 447 U.S. 303 (1980) [p.101] (Analysis: ) ISSUE: Whether a live, human-made micro-organism is patentable subject matter under § 101, as either "manufacture" or

"composition of matter." (101b) Statutory construction : Begin with the language of the statute. (442 U.S. 397) Unless otherwise defined, words will be inter-

preted as taking their ordinary, contemporary, common meaning. (Perrin v. U.S., 444 U.S. 37) Courts should not read into the patent laws limitations & conditions that the legislature has not expressed. (289 U.S. 178) “Manufacture” ≡ "the production of articles for use from raw or prepared materials by giving to these materials new

forms, qualities, properties, or combinations, whether by hand-labor or by machinery." “Composition of matter” ≡ "all compositions of two or more substances and . . . all composite articles, whether they be

the results of chemical union, or of mechanical mixture, or whether they be gases, fluids, powders or solids." Expansive terms + “any” Congress intended the patent laws would be given wide scope. (102m)

Committee Reports (1952 Act) : Congress intended statutory subject matter to "include anything under the sun that is made by man." Limits: laws of nature, physical phenomena, and abstract ideas; a new mineral discovered in the earth, a new plant found in the wild; relativity; Newton’s law of gravity. (102b)

Brennan dissent: (Antipathy to monopolies) v. (encourage progress). Careful to extend patent protection no further than Congress provided. If

no legislative direction leave to Congress the decisions whether & how far to extend the patent privilege. Microorganisms not unanticipated. Congress specifically excluded bacteria from the coverage of the 1970 Act.. This composition uniquely implicates matters of public concern. (patenting animal life forms)

Methods of Medical Treatment119-133

Utility133-159

General Principles134-141

Utility in Chemistry & Biotechnology141-149

(1:02:00) (Brenner v. Manson) & (in re Brana) represents 2 poles. The middle ground – can get a parent under Brana.

Brenner v. Manson 383 U.S. 519 (1966) [p.141] (Analysis: ) ISSUE: Whether the practical utility of the compound produced by a chemical process is an essential element in establishing a

prima facie case for the patentability of the process. Debate between:

Patent Law Outline 4/9/2023, 5:07 PM, Page 8 of 24 Bremmer view (PTO) : It was never intended that a patent be granted upon a product, or a process producing a product,

unless such product be useful. CCPA view : Sufficient that a process produces (the result intended) and is (not "detrimental to the public interest”).

Compelling consideration: Process patent in the chemical field, w/out specific utility, creates a monopoly of knowledge. Un-til the process claim has been reduced to production of a useful product, the boundaries of that monopoly are imprecise. May be vast. Would block off whole areas of scientific development w/out public benefit. Insufficient justification for permitting an applicant to engross what may prove to be a broad field. Applies equally to the patenting of the product produced by the process.

A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.Harlan dissent: (146t) Most troubling about the majority: Impact on chemical basic research. Requires a commercially useful item. Discourages

invention. Should resolve uncertainties in favor of basic research.

Utility Reqt at the Federal Circuit149-159

In re Brana 51 F.3d 1560 (Fed. Cir. 1995) [p.149] (Analysis: ) ISSUE: With regard to pharmaceutical inventions, what must the applicant prove regarding the practical utility or usefulness

of the invention for which patent protection is sought. § 112 ¶ 1: The specification shall contain a written description of the invention … enable any person skilled in the art … to

make and use the same … best mode contemplated The spec is presumed in compliance w/ enabling § 112 ¶ 1 unless there is reason to doubt its objective truth. Burden of proof: 1) Initially on the PTO when challenging a presumptively correct assertion of utility in the disclosure. 2) If

PTO provides evidence showing that one of ordinary skill in the art would reasonably doubt the asserted utility burden shifts to applicant to provide rebuttal evidence sufficient to convince such a person of the invention's asserted utility.

Proof of an alleged pharmaceutical property for a compound by statistically significant tests with standard experimental ani-mals is sufficient to establish utility.

Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development. Phase II testing too expensive to prove utility.

Anticipation159-179

Titanium Metals Corp. v. Banner 778 F.2d 775 (Fed. Cir. 1985) [p.161] (Analysis: ) § 102 novelty / anticipation: Claimed invention has not been "described in a printed publication in this or a foreign country,"

either (a) before invention by the applicant or (b) >1-yr before the application date to which he is entitled. The other publication must be enabling.

Elementary principle of patent law : When a claim covers several compositions (e.g., recitation), the claim is "antici-pated" if one of them is in the prior art.

Continental Can Co. v. Monsanto Co. 948 F.2d 1264 (Fed. Cir. 1991) [p.171] (Analysis: ) Anticipation under § 102(a): Must be an identical invention. If >1 reference, can’t have been anticipated under § 102.

Validity is determined in terms of § 103. The claim term must be construed as used by the patentee. DC cannot construe the terms. Anticipation when the reference is silent about the asserted inherent characteristic : Use extrinsic evidence. Must make clear

that the missing descriptive matter is necessarily present in the thing described in the reference, & recognizable by persons of ordinary skill.

Modest flexibility – can be “anticipated” w/out common knowledge of technologists being recorded in the reference;

Statutory Bars179-248

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Applicant Activities – § 102(b)182-220

Public Use Of a Device

Egbert v. Lippmann 104 U.S. 333 (1881) [p.182] (Analysis: ) ISSUE: Whether prior use requires consent of the inventor in order to invalidate a patent. Observations about Public use :

1. More usage of the patented articles is stronger proof, but one well-defined case can be enough. Example: One article pub-licly used for a long time.

2. Public / private does not necessarily depend on how many people know about it. Example: Public use if an inventor gives or sells it to another person w/out limit, restriction, or nondisclosure agreement, and it is then used in public public use.

3. The nature of some inventions permits use only where they are not publicly seen. Example: Lever or spring in a watch; ra-chet in a loom. If the inventor publicly sells a machine containing the invention, & used w/out restriction public use. However, public testing for experimentation is not a public use. Elizabeth v. Pavement Co.

Example: If the invention was complete (i.e., no testing) and was used in the manner designed by the inventor, then patent barred.

Of a Process

Metallizing Engr Co. v. Kenyon Bearing 153 F.2d 516 (2d Cir. 1946) [p.187] (Analysis: ) Inventor may continue for >1-yr to practice his invention for his private purposes of his own enjoyment and later patent it. Not

an exception to the doctrine – no commercial use; no extension of monopoly. Even that privilege has its limits – he may con-ceal it for so long that he will lose his right to a patent even though he does not use it at all. Not an issue here.

Learned Hand: Inventor shall not exploit his discovery competitively after it is ready for patenting. Either secrecy, or legal monopoly.

City of Elizabeth v. Am. Nicholson Pavement Co . 97 U.S. 126 (1878) [p.192] (Analysis: ) ISSUE: Whether public experimentation of an invention was in public use or on sale, potentially invalidating a patent. Abandonment to the public may be evinced by inventor’s conduct at any time, even w/in 1-yr. Not necessarily so from pub-

lic use or on sale, w/ inventor's consent & allowance w/in 1-yr before his application. However, public use or sale >1-yr be-fore application conclusive evidence of abandonment & patent void.

Public experimentation is incidental public use, not enough to void patent.

Pfaff v. Wells Elecs . 525 U.S. 55 (1998) [p.211] (Analysis: ) ISSUE: Whether commercial marketing of a newly invented product may mark the beginning of the 1-year period even

though the invention has not yet been reduced to practice. § 103: "A patent may not be obtained though the invention is not identically disclosed or described . . . if the differences be-

tween the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains."

"Invention" in the Patent Act refers to the inventor's conception, not physical embodiment. No express requirement for reduc-tion to practice before it can be patented. Matters just for § 102(g) – standard for resolving priority contests: dates of concep-tion & reduction to practice; reasonable diligence.

Well settled that an invention may be patented before it is reduced to practice. Example: Bell’s telephone patent. Spec accurately described, with sufficient precision to enable one of ordinary skill in such matters to make it. Mechanic’s

skill. Law does not require that the inventor to have perfected his art. Policy args:

Patent system is a carefully crafted bargain: (Encourages creation & public disclosure of new and useful advances in tech-nology) weighed against (Exclusive monopoly for a limited period of time). Motivation by rewarding invention // Interest in avoiding monopolies – in patent laws from the beginning.

Patent Act limits, by excluding ideas in the public domain & limiting duration of the patent monopoly. Public use before filing a patent application lose his right to a patent (w/ exceptions). Pennock v. Dialogue. But an in-

ventor may conduct extensive testing w/out losing his right to a patent, even if the testing is public. Long recognized dis-tinction between (experimental use) & (commercially sold).

“Invention” must refer to a concept that is complete, not merely "substantially complete." Reduction to practice is the best evi-dence. But reduction to practice isn’t necessary in every case. Telephone Cases: One can prove that an invention is com-plete & ready for patenting before it has actually been reduced to practice.

Patent Law Outline 4/9/2023, 5:07 PM, Page 10 of 24 The on-sale bar applies when, before the critical date, when:

1. Product was the subject of a commercial offer for sale. Example: Accepting a PO; not experimental in character.2. Invention must be ready for patenting. Satisfy in at least 2 ways. Proof that prior to the critical date:

A. Was reduced to practice; or B. Inventor had prepared drawings or other descriptions of the invention that were sufficiently specific to enable a per-

son skilled in the art to practice the invention. Example: Sending engr drawings to mfr.

Third Party Activities – § 102(b)220-230

Electric Storage Battery Co. v. Shimadzu 307 U.S. 5 (1939) [p.220] (Analysis: ) For a valid patent was to issue, the invention must not have been in public use in the U.S. for more than two years prior to the

filing of the application, even if already patented overseas.

Abbott Lab. v. Geneva Pharms., Inc. 182 F.3d 1315 (Fed. Cir. 1999) [p.222] (Analysis: ) ISSUE: § 102(b) on-sale bar. Patent invalid under § 102(b) if "the invention was . . . on sale in this country, >1-yr prior to the date of the application for

patent in the U.S." The statutory on-sale bar has no exceptions for sales made by 3d parties. Irrelevant if inventor didn’t make these sales. Doesn’t require “conception of the invention” (i.e., knowing what they were buying). Conception matters in priority disputes,

not the sale of material.Policy arg: A primary purpose of the on-sale bar is to prohibit the withdrawal of inventions that have been placed into the public domain

through commercialization.

W.L. Gore & Associates, Inc. v. Garlock, Inc. 721 F.2d 1540 (Fed. Cir. 1983) [p.226] (Analysis: ) ISSUE: § 102(b): Whether that sale would defeat Gore's right to a patent on the process inventions set forth in the claims. Mfr sold only tape, not the process for making it. Public couldn’t learn the process by examining the tape. Commercialized the

tape could invalidate any process patent filed >1-yr later. However, secret commercialization of a process can’t bar a process patent.

Patents, Printed Publications, & “In this Country” – §§ 102(a) & 102(b)230-243

In re Carlson 983 F.2d 1032 (Fed. Cir 1992) [p.231] (Analysis: ) ISSUES: 1) Whether the design protected by Geschmacksmuster (“G”) constitutes an "invention . . . patented . . . in . . . a

foreign country" w/in meaning of § 102(a) (prior art), & 2) Whether Des. 289,855 is unpatentable under § 103 (obvious) in light of the pertinent prior art.

Court: The reqt is only that patents be “available to the public.” Doesn’t matter if not readily accessible, or in medium not ca-pable of wide dissemination.

The G alerted the public to potentially relevant design, directing the reader to Coburg to get the actual design.

In re Hall 781 F.2d 897 (Fed. Cir. 1986) [p.235] (Analysis: ) ISSUE: Whether the thesis is available as such a printed publication. Competent evidence of the general library practice may be relied upon to establish an approximate time when a thesis became

accessible. Example: May be available only once indexed in the library catalog. Reject appellant's arg that a single cataloged thesis in one university library does not constitute sufficient accessibility to those

interested in the art exercising reasonable diligence.

Abandonment – § 102(c)243-244

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Delayed U.S. Filing – § 102(d)244-248

Novelty: Prior Invention248-308

Prior Invention under § 102(a)249-255

Gillman v. Stern 114 F.2d 28 (2d Cir. 1940) [p.250] (Analysis: ) Secret use of an invention ≠ "public use" Can’t invalidate 3d party’s patent as "first inventor."

Exception: Disclosure to show performance, not construction, is still secret. A secret inventor is not a "first inventor." What does not in fact enrich the art should not count. Difference between a public user which does not inform the art & a secret user: Secret uses ≠ public uses, regardless of

public value. Resulting anomaly: By secreting a machine one may keep it from becoming an anticipation, even though its public use

would really have told nobody anything about it.

Elements of “Invention” Under § 102(g)255- 287

Oka v. Youssefyeh 849 F.2d 581 (Fed. Cir. 1988) [p.260] (Analysis: ) ISSUE: Conception; Priority in an interference. Conception requires (1) the idea of the structure of the chemical compound, and (2) possession of an operative method of

making it.1. The directing conception : The idea that a certain desired result may be obtained by following a particular general plan –

e.g., the inventive concept, thought or idea. 2. Selection of means for effectively carrying out the directing conception :

O = senior party. Y required to establish: 1) Reduction to practice before O's filing date & not (abandoned/supp/concealed), or 2) (Conception before O’s filing date) + (reasonable diligence from before O’s filing date to Y's filing date). § 102(g). Where testimony merely places the acts within a stated time period, the inventor has not established a date for his activities earlier than the last day of the period.

(Y's conception date) = (O's filing date), 10-31-1980. O, as senior party, is presumptively entitled to award of priority. Y, as junior party in an interference between applications, must overcome w/ preponderance of the evidence. Tie awarded to the se-nior party. O is entitled to priority; reverse board's award of priority to Y.

Scott v. Finney 34 F.3d 1058 (Fed. Cir. 1994) [p.264] (Analysis: ) Interference proceeding. Applications were copending. S the junior party in this interference, burden to show prior invention

by a preponderance of evidence. To show prior invention : 1) Reduction to practice before the senior party; OR, 2) If the junior party reduced to practice

later, (conception before the senior party) + (reasonable diligence in reducing to practice). To show reduction to practice : Junior party must demonstrate that the invention is "suitable for its intended purpose." If

testing used to prove actual reduction to practice, it must actually work for its intended purpose. Here: S relied on testing court must examine testing to find reduction to practice.

Testing sufficient to show reduction to practice : Some devices may be so simple that construction demonstrates workabil-ity. Simple devices need no testing to show reduction to practice. Testing requirement depends on the particular facts of each case. Common sense to weigh sufficiency. Need not be in

a commercially satisfactory stage of development. Testing need only show utility beyond a probability of failure. Reasonableness standard.

Complex inventions : May require realistic laboratory tests. Examples: Electrical circuit @ high voltage; windshield wiper blades w/ wind; oscilloscope testing w/ high speed switching; binary counter for sophisticated radar & video equipment under various electrical conditions & temperature, vibration, sustained use, etc.

Less complex inventions : Stringent testing not required. Example: Exercise chair. Summary : Apply “common sense” in determining the extent of testing required. Character of the testing varies

with the character of the invention and the problem it solves.

Gould v. Schawlow 53 C.C.P.A. 1403 (1966) [p.272] (Analysis: )

Patent Law Outline 4/9/2023, 5:07 PM, Page 12 of 24 ISSUE: What is reasonable diligence in reducing to practice? Reasonable diligence requires establishing what was done and when it was done. Mere time took ≠ extent of time gaps in his

activity. Must account for the entire period during which diligence is required. Gould has not done so here. Diligence > mere conversation or keeping an idea under consideration. Policy arg: Intent of Congress to assure the first inventor that he should not be deprived of his reward by reasonably unavoidable delays.

But the public must have the advantage of the inventor's discovery as early as reasonably possible.

Woodland Trust v. Flowertree Nursery 148 F.3d 1368 (Fed. Cir. 1998) [p.280] (Analysis: ) A person can not patent what was already known to others. If known or used by others in this country before patentee's inven-

tion no new knowledge no patent. That knowledge or use must have been available to the public (i.e., knowledge or use is accessible to the public); Ex-

cludes private knowledge not known to the public. Abandonment of the prior use may preclude a challenge under § 102(g).

District ct: § 102(b): 1-yr grace period for publication, public use, sale. After that, inventor is barred from a patent. Encour-ages prompt patents. Inventor's own prior commercial use, even if secret, may be a public use or sale under § 102(b), barring patent. (Egbert v. Lippmann) When the prior use is not by the applicant, § 102(b) doesn’t bar a patent when that prior use or knowledge is not available

to the public. (W.L. Gore & Assocs., Inc. v. Garlock, Inc.) Heavy burden to challenge patent validity by oral testimony of interested persons and their friends, particularly as to

long-past events. Corroboration of oral evidence of prior invention is the general rule in patent disputes. Oral testimony is regarded with

skepticism. Such inventor testimony must be supported by corroborating evidence. “Rule of reason” factors of corroboration:

1) Relationship between the corroborating witness and the alleged prior user,2) Time period between the event and trial3) Interest of the corroborating witness in the subject matter in suit,4) Contradiction or impeachment of the witness' testimony,5) Extent & details of the corroborating testimony,6) Witness' familiarity with the subject matter of the patented invention and the prior use,7) Probability that a prior use could occur considering the state of the art at the time,8) Impact of the invention on the industry, and the commercial value of its practice.

Patent Award to the Second Inventor287-295

Apotex USA v. Merck 254 F.3d 1031 (Fed. Cir. 2001) [p.287] (Analysis: ) ISSUE: “Suppression / concealment” w/in § 102(g). § 102(g): Once a patent challenger proves by clear & convincing evidence that the invention was made in this country by an-

other inventor, burden shifts to patentee to show GIMF as to whether the prior inventor suppressed / concealed the invention. Two types of suppression / concealment: 1) Inventor actively suppresses / conceals invention from public; 2) Unreasonable

delay in filing a patent application Legal inference of suppression / concealment (e.g., 4 yrs after the invention was per-fected; 2-yr & 5-mo delay between reduction to practice & filing a patent application.

Prior inventor’s delay in revealing invention raises a similar inference of suppression / concealment. No explicit disclosure requirement in § 102(g), but patent laws encourage disclosure or else run the risk of someone else

patenting it. Secret prior art may not be used to invalidate a patent under § 102(g). Prior invention will be deemed suppressed / concealed w/in meaning of § 102(g) if, w/in a reasonable time after comple-

tion, no steps are taken to make the invention publicly known. § 102(g) prior inventor need not file a patent application in order to defeat another patent, as long as it wasn’t aban-

doned, suppressed, or concealed.

Disclosure in the U.S. Patent Applications § 102(e)295-300

Alexander Milburn Co. v. Davis-Bournonville Co . 270 U.S. 390 (1926) [p.295] (Analysis: )

Patent Law Outline 4/9/2023, 5:07 PM, Page 13 of 24 Defenses to infringement include that the patentee 'was not the original & 1 st inventor or discoverer of any material & substan-

tial part of the thing patented. A previous foreign invention doesn’t invalidate a U.S. patent if it has not been patented or described in a printed publica-

tion. Publication in a periodical is a bar. One must be the 1st inventor in order to be entitled to a patent. Fundamental rule : The patentee must be the 1st inventor.

1st to File vs. 1st to Invent305-308

Nonobviousness308-411

Hotchkiss v. Greenwood 52 U.S. 248 (1851) [p.311] (Analysis: ) Substitution of a different material in a machine or manufacture.

Not patentable if distinguishable from the old machine only by use of materials better adapted for that use. A formal difference, w/out ingenuity. Evidence of judgment & skill, but nothing more.

Required (more ingenuity & skill than possessed by an ordinary mechanic acquainted with the business) in applying (the old method of fastening shank & knob) when used with (a porcelain knob). This improvement is the work of the skilful mechanic, not that of the inventor.

Historical Standard of Invention311-319

Great A&P Tea Co. v. Supermarket Equipment Corp . 340 U.S. 147 (1950) [p.315] (Analysis: ) ISSUE: The correct criteria of invention. The key to patentability of a device combining together old factors is presence or absence of invention.

Combination ≡ presence of invention. Aggregation ≡ lack of invention. Legal antonyms, but common synonyms. How-ever the words of art result in nothing but confusion. The concept of invention is inherently elusive when applied to combination of old elements.

If the whole in some way exceeds the sum of its parts, then the whole is patentable. Some new quality / function from being brought into concert.

Modern Standard of Nonobviousness319-381

Graham v. John Deere Co . 383 U.S. 1 (1966) [p.319] (Analysis: 1) § 103(a), Obviousness: The subject matter as a whole would have been obvious at the time the invention was made to a per-

son having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made."

Patentability depends upon novelty, utility, and the "non-obvious" nature of the subject matter to a person having ordinary skill in the pertinent art. Congress: § 103 codifies decisions of the courts. An invention, new in the sense that the same thing has not been made

before, may be unpatentable if the difference between new & old isn’t sufficiently great to warrant a patent. If the differ-ence would have been obvious at the time to a person skilled in the art unpatentable.

Difficulties in applying: Obviousness doesn’t have a uniform answer in every factual context. Comparable to negligence & scienter. Case-by-case development.

An invention is construed not only in the light of the claims, but also with reference to the file wrapper or prosecution history in the Patent Office. Allowed claims must be read & interpreted with reference to rejected claims & the state of the prior art; claims narrowed in order to get a patent by distinguishing the prior art cannot be used to cover that which was previously eliminated from the patent.

US v. Adams 383 U.S. 39 (1966) [p.336] (Analysis: )

Patent Law Outline 4/9/2023, 5:07 PM, Page 14 of 24 An inoperable invention or one which fails to achieve its intended result does not negative novelty. Equivalent substitutions Equivalent operating characteristics. Counterexamples:

“Wholly unexpectedly” characteristics having valuable operating advantages over other products. Nonobviousness indicators:

Unexpected operating characteristics together, even it elements are individually well known in the prior art. Runs counter to prior art, expert wisdom, or long-accepted factors. Examples: 1) batteries w/ open circuit & exothermic

were not practical; and 2) water-activated batteries required electrolytes detrimental to Mg. Known disadvantages in old devices which would naturally discourage the search for new inventions may be taken

into account in determining obviousness. More factors bearing on obviousness: 1) Noted experts expressed disbelief in Adams’ perfected invention. 2) Other experts

recognized the significance of the Adams invention, some patenting improvements; 3) PTO found no references to cite against the Adams application.

Hybritech, Inc. v. Monoclonal Antibodies, Inc. 802 F.2d 1367 (Fed. Cir. 1986) [p.359] (Analysis: ) § 103 obviousness – whether the claimed invention would have been obvious at the time the invention was made. Objective evidence such as commercial success, failure of others, long-felt need, and unexpected results must be considered

before a conclusion on obviousness is reached.Objective Evidence of Nonobviousness Commercial success : Example: Sales ▲. Unexpected Advantage : Example: Unexpectedly solved long-standing problems.

Prior Art for Nonobviousness411-438

Analogous Arts428-438

In re Clay 966 F.2d 656 (Fed. Cir. 1992) [p.428] (Analysis: ) “Analogous” – fact question. Clearly erroneous standard. Criteria for determining whether prior art is analogous: 1) From the same field   of endeavor , regardless of the problem ad-

dressed, and 2) Different field but still reasonably pertinent to inventor’s problem.

Patent Specification: Objective Disclosure438-497

Enablement439-470

Gould v. Hellwarth 472 F.2d 1383 (CCPA 1973) [p.439] (Analysis: ) Enablement not found when OSITA wouldn’t be able to build it. Adequate disclosure of the Q feature if application adequately disclosed an operable laser in which the Q could be used.

Atlas Powder Co. v. E. I. Du Pont de Nemours & Co. 750 F.2d 1569 (Fed. Cir. 1984) [p.449] (Analysis: ) Enablement under § 112: Patent must contain a description that enables OSITA to make & use the claimed invention. Small

amount of experimentation, not unduly extensive, doesn’t preclude enablement. List of ingredients : Even if some combinations were inoperative, the claims are not necessarily invalid.

If significant # of inoperative combinations, forcing undue experiment, claims might indeed be invalid. Prophetic examples (i.e., predicting something) don’t automatically make a patent non-enabling. Burden on challenger (C&C

evidence) that the prophetic examples + spec are not enabling. Du Pont did not meet that burden here. Experimentation would help OSITA make the invention. OSITA would know how to make the "failures" work.

Patent Law Outline 4/9/2023, 5:07 PM, Page 15 of 24

“Written Description” – Proscription on New Matter470-481

Vas-Cath, Inc. v. Mahurkar 935 F.2d 1555 (Fed. Dir. 1991) [p.471] (Analysis: ) ISSUE: § 112 ¶ 1 "written description" adequate to support each claim. At issue when: 1) claims not in the application when filed are presented thereafter (Most often); 2) Patent applicant seeks ben-

efit of the filing date of an earlier application under § 119 or § 120 for claims of a later-filed application. Whether the application provides "adequate support" for the claims at issue; Also analyzed as "new matter" under § 132. Interference context: Whether the spec of one party can support the claim corresponding to the interference count.

Rationale for written description in addition to claims : 1) historical; 2) public notice of what claimed as his own invention; as-certain if invalid; warn innocent infringer; proof that it works & different than other inventions; 3) Policy rationale: Relation-ship between description / definiteness – complementary, but approach from different directions. Adequate description: Guards against overreaching. Definiteness: Gives notice to 3d parties.

Spec must disclose to OSITA something appellants actually invented. Possible for a spec to enable practice of an invention as broadly as it is claimed, and still not describe that invention. Example: If spec discusses only compound A w/out broadening language might enable OSITA to make & use B & C; yet class {A, B, C} not been described.

§ 112 “Written description” reqt: Not exact description of the subject matter, but must clearly allow persons of OSITA to recognize what is claimed. Test for sufficiency: Whether the disclosure reasonably conveys to OSITA that the inventor had possession at that time

of the later claimed subject matter. Question of fact - clearly erroneous standard.

Univ. of Rochester v. G.D. Searle & Co. 249 F.Supp.2d 216 (W.D. N.Y., March 2003) [p.handout] (Analysis: ) Written description of a method. Is function adequate where the only means for finding such a compound is trial & error?Written-Description Requirement – General Spec must describe every element of the claimed invention in sufficient detail so that OSITA would recognize that the inven-

tor possessed the claimed invention at the time of filing. Biotechnology Patents-Defining a Substance by its Function Adequate written description of a compound ≡ structure, formula, chemical name, or physical properties; not a wish or plan. “A mere wish or plan” for obtaining an invention is not enough to comply with § 112, ¶ 1

Written description requirement met by disclosure sufficiently detailed, relevant identifying characteristics. Example: Functional characteristics when coupled with a known or disclosed correlation between function and structure.

Reference in the spec to a deposit in a public depository, thus publicly accessible, is an adequate description to comply w/ § 112.

If claims directed to “astronomical” # mutated variations, GIMF whether the deposited sequences would describe those subsequences and variations to one of skill in the art sufficiently to demonstrate possession of the generic scope of the claims.

Even if a claim is supported by the specification, the language of the specification must describe the claimed invention so that OSITA can recognize what is claimed. Example: Description steroid, described in terms of its function, fails to distinguish it from other steroids having the same

function. A description of what a material does, rather than of what it is, usually does not suffice.Enablement Requirement - General Standards Spec must teach OSITA how to make & use the full scope of the claimed invention w/out “undue experimentation.”

The test for undue experimentation is not merely quantitative, if it is routine testing, or if the spec provides a reasonable amount of guidance wrt the direction in which the experimentation should proceed.

Factors for undue experimentation include: 1) Quantity of experimentation necessary, 2) Amount of direction or guid-ance presented, 3) Presence or absence of working examples, 4) Nature of the invention, 5) State of the prior art, 6) Rela-tive skill of those in the art, 7) Predictability or unpredictability of the art, and 8) Breadth of the claims.

Patent Specification: Best Mode497-525

Chemcast Corp. v. Arco Industries Corp. 913 F.2d 923 (Fed. Cir. 1990) [p.497] (Analysis: ) § 112: Critical distinction between requirement [A], "enablement," and requirement [B], "best mode."

Enablement : Disclose so OSITA can make & utilize it.

Patent Law Outline 4/9/2023, 5:07 PM, Page 16 of 24 Best mode : Requires an inventor to disclose the best mode contemplated by him, at time of application. Prevent patents

while concealing the preferred embodiments. Inventor's state of mind @ application. Limits:

Must consider the level of skill in the relevant art. A function of inventor’s knowledge & how OSITA would understand. Scope of the claimed invention. Example: Failure to disclose info to enable interchangeability didn’t invalidate patent be-

cause interchangeability wasn’t part of the claims. Best mode analysis has two components: 1) Whether, at time of application, inventor knew of a best mode. Subjective; in

addition to enablement. If preferred mode, then 2) Compares what he knew with what he disclosed – concealment or enough for OSITA? Adequacy v. necessity - objective inquiry.

Claims525-594

U.S. Peripheral Claiming Technique526-533

Ex parte Fressola 27 U.S.P.Q.2D 1608 (1993) [p.526] (Analysis: ) Original method: Central definition – claims named the broad features + phrase like "substantially as set forth. Modern claim interpretation: Peripheral system –scope of the claim not expanded. Example: Doctrine of equivalents does

not expand claims, it only expands right to exclude to "equivalents". Requires that the claims particularly point out and dis-tinctly claim the invention without reading in limits from the spec.

Claims define the boundary of the invention. The metes and bounds of the invention must be clearly set forth in order that the public has notice.

Patent Claim Format533-583

Claim Definitiveness583-594

Orthokinetics, Inc. v. Safety Travel Chairs, Inc. 806 F.2d 1565 (Fed. Cir. 1986) [p.584] (Analysis: ) Invalidity under § 112 ¶ 2 requires a determination of whether OSITA would understand what is claimed when the claim is

read in light of the specification. Q of law.

Prosecution594-674

Overview of Patent Prosecution595-606

Transco Prods. v. Performance Contracting 38 F.3d 551 (Fed. Cir. 1994) [p.597] (Analysis: ) "Continuation" and "divisional" applications: Both are continuing applications based on the same disclosure as an earlier

application. Different in what they claim. Continuation: Claims the same invention as an earlier application. May have some variation in the scope of the subject

matter claimed. Filed during the pendency of another application which contains at least part of the disclosure of the other application and names at least one inventor in common with that application.

Divisional: Carved out of an earlier application which disclosed & claimed more than one independent invention. The divisional application claims only one or more, but not all, of the independent inventions of the earlier application. See MPEP § 201.06.

CIP: A continuing application containing a portion or all of the disclosure of an earlier application together with added matter not present in that earlier application. See MPEP § 201.08.

Patent Law Outline 4/9/2023, 5:07 PM, Page 17 of 24

Inventorship606-627

Ethicon, Inc. v. US Surgical Corp. 135 F.3d 1456 (Fed. Cir. 1998) [p.606] (Analysis: ) Inventorship is a question of law - review w/out deference. Underlying facts wrt inventorship reviewed for clear error. Each joint inventor must generally contribute to the conception of the invention.

Conception ≡ formation in the mind of a definite & permanent idea of the complete & operative invention. “Definite & permanent” when only ordinary skill necessary to reduce to practice, w/out extensive research / tests.

Must include every feature of the subject matter claimed in the patent. Different types / amounts of contribution OK. May contribute to only part of the invention. More than merely assisting the actual inventor after conception. Providing well-known principles or explaining the state

of the art w/out having "a firm & definite idea" of the invention as a whole ≠ joint inventor. OSITA who simply reduced the inventor's idea to practice ≠ joint inventor.

Omitted co-inventor may be added to the patent by a court. § 256 Prove contribution to claims by clear & convincing evidence. Co-inventor's testimony wrt facts of invention by itself ≠ clear & convincing proof. Must corroborate (e.g., contempora-

neous documents; inventive process; others’ oral testimony) “Rule of reason” standard for corroborating evidence: 1) Consider evidence in context, 2) Determine credibility, and

3) Assign probative weight to the evidence.Newman dissent: Look at ownership of each claim separately. Joint ownership rules were relaxed in 1984.

Hess v. Advanced Cardiovascular Sys. 106 F.3d 976 (Fed. Cir. 1997) [p.619] (Analysis: ) Offering advice ≠ conception. Invention requires thorough knowledge, from books or experts. Inventor may use the services, ideas, & aid of others to perfect his invention without losing his right to a patent.

Inequitable Conduct627-648

Kingsdown Medical Consultants, Ltd. v. Hollister, Inc. 863 F.2d 867 (Fed. Cir. 1988) [p.629] (Analysis: ) ISSUE: Intent to deceive. Inequitable conduct: Examples: Failure to disclose material information; submission of false material information w/ intent

to deceive. Materiality & intent must be proven by clear & convincing evidence. “Intent” wrt inequitable conduct can’t always be inferred from gross negligence. Conduct must be sufficient to require a find-

ing of deceitful intent in the light of all the circumstances.

Molins PLC v. Textron 48 F.3d 1172 (Fed. Cir. 1995) [p.639] (Analysis: ) Inequitable Conduct: Patents applicants are required to prosecute applications in the PTO w/ candor, good faith, & honesty.

Includes affirmative misrepresentation of a material fact, failure to disclose material information, or submission of false material information, w/ intent to deceive.

If arising from a failure to disclose prior art, must offer clear & convincing proof of the materiality of the prior art, knowl-edge chargeable to the applicant of that prior art and of its materiality, & applicant's failure to disclose the prior art + in-tent to mislead PTO.

Double Patenting648-674

Post-Grant Procedures674-699

Patent Law Outline 4/9/2023, 5:07 PM, Page 18 of 24

Reexamination687-696

In re Recreative Techs. Corp. 83 F.3d 1394 (Fed. Cir. 1996) [p.687] (Analysis: )The Reexamination Statute

Must have a substantial new question of patentability. Identical ground is barred. If no new question of patentability improper to conduct reexamination on an old question.

Legislative History of Public Law 96-517 Principal benefits of re-exam statute: 1) Basing on references not previously included in the original examination could

resolve validity disputes more quickly & less expensively than litigation. 2) Courts benefit from PTO expertise for prior art not previously of record. 3) Re-exam would strengthen confidence in patents whose validity was clouded.

Balance (broad purpose) against (potential for abuse) - unwarranted re-exams harass patentee & waste patent life. Serious legislative concern that re-exams not promote abusive tactics & burdensome procedures. Re-exam carefully limited to new prior art. No other grounds of re-exam permitted. Matters decided in the original exam would be barred from re-exam. Bar reconsideration of any argument already decided by PTO, whether during the original exam or an earlier re-exam.

Explicit in § 303: Reexamination is barred for questions of patentability that were decided in the original examination. The policy balance reflected in the statute can’t be unilaterally realigned by the agency.

Infringement744-910

Literal Infringement749-776

Markman v. Westview Instruments, Inc. 52 F.3d 967 (Fed. Cir. 1995) [p.749] (Analysis: ) To ascertain the meaning of claims, we consider three sources: 1) claims, 2) spec, and 3) prosecution history.

Expert testimony, including evidence of how those skilled in the art would interpret the claims, may also be used. Claims must be read in view of the specification. For claim construction purposes, the description may act as a dictio-

nary, which explains the invention and may define terms used in the claims. Patentee is free to be his own lexicographer . Caveat: Any special definition must be clearly defined in the specification. Written description in the spec doesn’t delimit the right to exclude. That is the function and purpose of claims.

Construing claim language: Consider prosecution history if in evidence. Undisputed public record of PTO proceedings is of primary significance in understanding the claims. Court has broad power to look as a matter of law to the prosecution history in order to ascertain the true meaning of language used in the patent claims. Prosecution history should be used to understand the language used in the claims, but cannot "enlarge, diminish, or vary"

the limits in the claims. Extrinsic evidence: Examples: Expert & inventor testimony, dictionaries, & learned treatises. Helpful to explain scien-

tific principles, meaning of technical terms, & terms of art. Extrinsic evidence may demonstrate the state of the prior art at the time of the invention.

Construing claims ≈ using helpful extrinsic evidence, rejecting unhelpful evidence, & resolving disputes to pronounce the meaning of claim language as a matter of law based on the patent itself.

Doctrine of Equivalents776-798

Graver Tank & Mfg. Co. v. Linde Air Products Co . 339 U.S. 605 (1950) [p.777] (Analysis: ) 1st look to the words of the claim. If accused matter falls clearly within the claim, that is the end of it.

Permitting equivalents makes patent protection hollow & useless. Encourages unimportant & insubstantial changes & substitutions

DoE : Prohibit a device "if it performs substantially the same function in substantially the same way to obtain the same result. Theory: (Same way) + (same result) they are the same, even though they differ in name, form, or shape. Protects patentee of a pioneering invention, and also patentee of a secondary invention consisting of a combination of old

ingredients which produce new and useful results.

Patent Law Outline 4/9/2023, 5:07 PM, Page 19 of 24 Can be used against patentee (prior art). Applied to devices, compositions (equivalence between chemical ingredients).

Equivalency determined against the context of the patent, prior art, & particular circumstances of the case. Not an absolute to be considered in a vacuum. It doesn’t require complete identity for every purpose & in every respect. Consider the purpose why an ingredient is used in a patent: qualities w/ other ingredients; intended function. Important

factor: Whether OSITA would have known of the interchangeability. Equivalence is a determination of fact. Example Proofs: Expert testimony; documents (e.g., texts & treatises); disclosures of

the prior art. Requires a balancing of credibility, persuasiveness & weight of evidence. Decided by trial court; reviewed under clearly erroneous standard. Rationale: So much depends upon familiarity w/ specific scientific problems & principles not usu-ally in common knowledge & experience.

Warner-Jenkinson Co. v. Hilton Davis Chem. Co . 520 U.S. 17 (1997) [p.782] (Analysis: 1, 2)Thomas opinion: Supreme Court: Concern that the DoE, as applied since Graver Tank, is unbounded by the patent claims. Broad application

of DoE conflicts w/ definitional & public-notice functions of the statutory claiming reqt. Nies solution: Distinction between (equivalent for a component in an invention) & (enlarging the metes and bounds of

the invention beyond claims). Reconciles view that (accused device must be more than 'equivalent' overall) with Supreme Court position that

(courts have no right to enlarge a patent beyond the scope of its claims as allowed by PTO). Scope isn’t enlarged if courts don’t go beyond the substitution of equivalent elements.

Concur w/ Nies. (Each patent claim element is material to defining scope) (DoE must be applied to individual ele-ments of the claim, not to the invention as a whole). DoE, even for individual elements, can’t be so broad so as to effectively eliminate that element entirely.

Prosecution estoppel. Considering the reasons for surrender undermine clear notice of patent scope. Reason for an amendment during prosecution is important. Where change was unrelated to avoiding prior art, it may introduce a new element, but doesn’t necessarily pre-

clude infringement by DoE of that element. Rule: Place burden on the patent-holder to establish the reason for an amendment required during prosecution. Court then

decides if sufficient to overcome prosecution history estoppel as a bar to DoE to that element. No explanation court should presume that the PTO had a substantial reason related to patentability prosecution

history estoppel bars DoE as to that element. Rebuttable presumption if appropriate reason is established. Objective nature DoE: OSITA’s knowledge of the interchangeability is relevant evidence about the similarities / differences

between those elements. Question under DoE: Whether an accused element is equivalent to a claimed element - evaluate equivalency & knowledge of interchangeability at the time of infringement.

Linguistic framework to determine “equivalence”: Triple identity test: 1) function of a particular claim element; 2) way that element serves that function; 3) result obtained. Triple ID may be suitable for analyzing mechanical devices, but a poor framework for analyzing other products or processes. Insubstantial differences test: Offers little additional guidance about the difference between substantial & insubstantial.

Limits on DoE798-842

Corning Glass Works v. Sumitomo Electric U.S.A., Inc. 868 F.2d 1251 (Fed. Cir. 1989) [p.799] (Analysis: ) ISSUE: Meaning of “same way” in DoE. (substantially same function) + (same result) doesn’t infringe under DoE where it uses a substantially different way. Common

in competition. All Elements rule : Infringement requires that each element of a claim or its substantial equivalent be found in the accused

device. Court of Appeals: Don’t agree that an "element" of the claim is entirely "missing" from S-3. "Element" may be a single limit; or a series of limits which together make up a component of the claimed invention. In

All Elements rule, "element" limits a claim.

Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co . 535 U.S. 722 (2002) [p.808] (Analysis: ) ISSUE: Relation between 1) Doctrine of equivalents; and 2) Prosecution history estoppel.

Rely on prosecution history. If claims narrowed Estops him from later arguing that the subject matter covered by the original, broader claim was nothing more than an equivalent.

Prosecution history estoppel: Estoppel ensures claims interpreted in light of the prosecution history. DoE: Allows patentee to claim insubstantial alterations not in the original patent claim.

Patent Law Outline 4/9/2023, 5:07 PM, Page 20 of 24 However, if (patentee originally claimed infringing subject matter) then (narrowed claim in response to a rejection)

may not argue that the surrendered territory comprised unforeseen subject matter claimable under DoE. Contrary - by amending, patentee recognizes that the difference were material.

Rejection ≡ examiner didn’t believe the claim was patentable. Appeal possible, but (decision to forgo appeal & amended claim) ≡ (concession that patented doesn’t original claim). Prosecution history estoppel precludes patentee from regain-ing, through litigation, coverage of subject matter relinquished during prosecution of the application for the patent. Ratio-nale: Otherwise, inventor might avoid PTO's gatekeeping, & try to recapture in an infringement suit the very subject mat-ter surrendered as a condition of getting the patent.

Kinds of amendments that give rise to estoppel. SCt: Warner-Jenkinson – estoppel doesn’t arise whenever patent is amended - only for limited reasons (e.g., avoid the

prior art, or obviousness) that otherwise would make the claimed subject matter unpatentable. W-J didn’t define it or cata-log every reason. Even if unrelated to patentability, it might still give rise to estoppel.

Estoppel arises when an amendment, to secure the patent, narrows the patent's scope. If § 112 Am is cosmetic, ≠ narrow & no estoppel. If § 112 Am necessary & narrows (even if only for a better description) estoppel. (Narrow as a condition for patent) ≡ (disavowal of broader subject matter). Patentee conceded an inability to claim the broader subject matter; or at least abandoned his right to appeal a rejection Estoppel applies.

Wilson Sporting Goods Co. v. David Geoffrey & Assoc. 904 F.2d 677 (Fed. Cir. 1990) [p.834] (Analysis: ) ISSUE: Using DoE defensively. If a patent avoids prior art, it also avoids other products which are equivalents under DoE.

Experimental Use845-857

Intermedics v. Ventritex, Co. 775 F. Supp. 1269 (N.D. Cal. 1991) [p.846] (Analysis: ) Affirmative defense § 271(e)(1): Clinical trial exemption. Not patent infringement to make, use or sell a patented invention

solely for uses reasonably related to the development & submission of information under a federal law which regulates the manufacture, use, or sale of drugs. Also applies to medical devices subject to FDA approval.

Corrected 2 unintended distortions produced by the reqt for pre-market regulatory approval.1. Patentholder of device / drug subject to FDA approval couldn’t reap rewards from patent while product undergoing sub-

stantial testing & regulatory approval. 1984 Act § 201 established a patent term extension for patents related to certain products subject to lengthy regulatory delays & that couldn’t be marketed prior to regulatory approval.

2. Other end of the patent term. Overruled Roche. Congressional concern that generics in market place would be unduly de-layed if FDA bioequivalency testing couldn’t begin until patent expiration. Patentee's monopoly would continue for a substantial time until regulatory approval of generic. § 271(e)(1)) allows competitors, before patent expiration, to engage in otherwise infringing activities reasonably related to regulatory approval.

Choice between 2 competing interests: 1) Full patent holders protection; 2) Assuring public access to medically beneficial new products at lower prices immediately after patents expiration. Elevated public health care interests above pecuniary interests of patent holders. Permitted competitors during patent to engage otherwise infringing acts, as long as for generating FDA data. May deprive

patent holders of significant sales, but patent holders retain the lion's share of the relevant markets. Congress wanted competitors to become ready, during patent, to enter marketplace as soon as patents expired. (No practi-

cal effect of extending patent monopoly.)

Indirect Infringement857-875

Hewlett-Packard Co. v. Bausch & Lomb 909 F.2d 1464 (Fed. Cir. 1990) [p.857] (Analysis: )Active Inducement -- 35 U.S.C. § 271(b) Patent Act of 1952: legislative history no change in scope of "contributory infringement," but was divided between §§ 271(b)

and 271(c) into "active inducement" (a type of direct infringement) and "contributory infringement". § 271(c) prohibited contributory infringement described above (e.g., no legitimate use). Only proof of D's knowledge, not

intent, that his activity caused infringement. (Knowledge of both the use & the patent.) § 271(b) prohibited all other types of "contributory infringement." Active inducement. Codify pre-1952 law.

Level of knowledge / intent to find active inducement under § 271(b).

Patent Law Outline 4/9/2023, 5:07 PM, Page 21 of 24 § 271(b) facially broader than § 271(c) – doesn’t mention as an element of active inducement. From legislative purpose:

Proof of actual intent is required. Here: Intent is missing. Indemnification clause : Doesn’t generally establish intent to induce infringement, but intent can be inferred when the in-

demnification is intended to overcome a patent’s deterrent effect on infringers.

Process Patents875-883

Eli Lilly & Co. v. American Cyanamid Co. 82 F.3d 1568 (Fed. Cir. 1996) [p.875] (Analysis: ) ISSUE: Process Patent Amendments Act of 1988. Two-phased test of “made by”:

1) If that product would not be possible or commercially viable but for use of the patented process. (My road analogy – in-fringes if the process covers a bottleneck between A&B, and there are either no other roads, or the other roads are like dirt paths.); Defeat infringement There exists another way of producing the intermediate. Alleged infringer doesn’t in fact

need to use that alternative process.2) If the additional unpatented processing steps don’t change the physical / chemical properties of the product in a manner

which changes the basic utility of the product produced by the patented process. However, a minor change may be "mate-rial" if the change relates to an important physical or chemical property. Counterexample: Change in the physical form (e.g., the granules to powder, solid to liquid) or minor chemical conversion, (e.g., conversion to a salt, base, acid, hydrate, ester, or addition or removal of a protection group) not a "material" change.

Additional Defenses910-930

Laches & Estoppel911-920

Aukerman Co. v. R.L. Chaides Constr. Co. 960 F.2d 1020 (Fed. Cir. 1992) [p.911] (Analysis: ) Laches: Equitable defense under § 282. Bars damages prior to suit. Rationales: (a) Unreasonable delay, (b) material preju-

dice from delay. Laches presumed after 6-yrs from knew / should have known. Shifts burden of evidence, not persuasion. Equitable estoppel: Defense under § 282. Bars damages entirely.

3 elements: (A) Patentee misleading conduct reasonable inference that patent wouldn’t be enforced. Examples: State-ments, action, inaction, or silence where there was an obligation to speak; (B) Reliance by alleged infringer; (C) Alleged infringer would be materially prejudiced by suit.

LACHES D must prove: (1) Unreasonable / inexcusable delay filing suit length from when P knew / should have known; (2) Injury. Unreasonable delay depends on the circumstances. Injury: Economic or evidentiary.

Evidentiary: Inability to present a defense (e.g., loss of records, death of witness, unreliable memories). Economic: D will suffer damages preventable by earlier suit. Patentee may not intentionally lie silently in wait watch-

ing damages escalate, particularly where an infringer, w/ notice, could have switched to a noninfringing product. Consider & weigh P’s justification for delay. Examples: other litigation; negotiations w/ accused; poverty or illness under

limited circumstances; wartime conditions (force majeure?); extent of infringement; dispute over patent ownership. Equities may / may not require P to communicate reasons for delay to D.

D’s egregious conduct may defeat laches. Example: Conscious copying. Counterexample: Ignorance or a good faith belief in the merits of a defense.

Laches focuses on the reasonableness of P’s delay in suit. Factors: Length of delay, the seriousness of prejudice, the reason-ableness of excuses, D’s conduct or culpability.

Effect of Laches Defense: Bars partial or entire relief. P may have justifiable reasons for delay. Laches bars only damages prior to suit. If estoppel also applies, all relief denied & suit dismissed.

EQUITABLE ESTOPPEL Equitable estoppel focuses on what D was reasonably led to believe from P’s conduct. Bars all relief. Flexible. Important elements: (1) P, knowing the true facts, misled D (e.g., words, conduct or silence); (2) D’s

reliance; (3) Materially harm if P is later permitted to assert any claim inconsistent w/ his earlier conduct. Doesn’t require passage of an unreasonable period of time . Usually asserted w/ laches.

Patent Law Outline 4/9/2023, 5:07 PM, Page 22 of 24 D must know: 1) Patentee and/or patent; 2) D’s activities.

P’s misleading inaction + other facts may give inference that the claim is abandoned. Substantial Reliance: Reliance ≠ prejudice or harm. Counterexample: Building a plant, unaware of a patent, is harm but not

reliance. Requires a relationship or communication w/ P which lulls D into a sense of security. Material harm: Like laches, change of economic position or loss of evidence. Significant difference from laches: No presumption w/ equitable estoppel. Even w/ long delay, D must prove all of the fac-

tual elements of estoppel. Rationale: 1) Laches factors (delay resulting prejudice) are not elements of estoppel; 2) Estoppel is broader than in laches (whole suit) D needs proof, not a presumption.

Remedies930-1000

Injunctions931-941

Damages941-980

Panduit Corp. v. Stahlin Bros. Fibre Works, Inc. 575 F.2d 1152 (6th Cir. 1978) [p.941] (Analysis: ) § 284 Requires "damages adequate to compensate for the infringement." Not less than a reasonable royalty.

Reasonable royalty ≡ amount a business person would be willing to pay as a royalty & still sell it at a reasonable profit. Panduit Test: Patent owner must prove : (1) Demand for the patented product, (2) Absence of acceptable noninfringing sub-

stitutes, (3) Mfg & marketing capability to exploit the demand, and (4) Amount of the profit he would have made. Also known as DAMP test.

Rite-Hite Corp. v. Kelley Co. 56 F.3d 1538 (Fed. Cir. 1995) [p.947] (Analysis: ) Patentee’s actual damages from a direct competitor are competitor’s sales & profits. § 284 test for compensability is not solely a "but for" test in the sense of any & all damages. Not every conceivable harm

traceable. Not remote consequences (e.g., heart attack). Is it a compensable type? Proximate causation & forseeability required for other kinds of injuries. Question of legal compensability is one "to be

determined on the facts of each case upon mixed considerations of logic, common sense, justice, policy and precedent. Under § 284, balance (full compensation) w/ (reasonable, objective foreseeability). If injury was reasonably foreseeable

by infringing competitor injury is compensable absent a persuasive reason to the contrary. Here: RH’s lost sales of the ADL-100, directly competed, were reasonably foreseeable. Responsible foreseeable

full compensation compensable. “Entire market value rule” lost profits on 1,692 dock levelers. K’s arg: Set aside award because RH failed to establish that

the dock levelers were eligible under the entire market value rule. Court of Appeals: We agree. Damages on unpatented components sold w/in a patented apparatus: “Entire market value rule.” Permits recovery of

damages based on the value of a patentee's entire apparatus containing several features when the patent-related feature is the "basis for customer demand. Example: Applied to include unpatented components of a device when the unpatented and patented components are phys-

ically part of the same machine. Extended to allow inclusion of physically separate unpatented components normally sold w/ the patented components - single assembly, or parts of a complete machine, or they together constituted a single func-tional unit.

Enhanced Damages & Attorney Fees980-991

Read Corp. v. Portec, Inc. 970 F.2d 816 (Fed. Cir. 1992) [p.980] (Analysis: ) Enhanced Damages: Discretion of trial court. Wanton disregard; willful. Egregiousness. Factors (first 3 are “Bott factors”):

1) Whether the infringer deliberately copied the ideas or design of another2) Whether the infringer, when he knew of the other's patent protection, investigated the scope of the patent and formed a

good-faith belief that it was invalid or that it was not infringed; and

Patent Law Outline 4/9/2023, 5:07 PM, Page 23 of 243) Infringer's behavior as a party to the litigation.4) Defendant's size and financial condition.5) Closeness of the case.6) Duration of defendant's misconduct.7) Remedial action by the defendant.8) Defendant's motivation for harm.9) Whether defendant attempted to conceal its misconduct

Finding of willful infringement doesn’t mandate 3x damages. Factors above assist trial court in evaluating culpability & whether to exercise its discretion, & how much. DC must explain the basis for award.

Marking991-1000

Amsted Indus. v. Buckeye Steel Castings Co. 24 F.3d 178 (Fed. Cir. 1994) [p.991] (Analysis: ) Marking / Notice requirement of § 287:

Articles never marked Amsted precluded from damages prior to the date that B was notified of the infringement. § 287(a) : Absent marking, patentee may not recover damages w/out proof that "the infringer was notified of the infringe-

ment." Supreme Court (Dunlap v. Schofield, 152 U.S. 244 (1894)): Clear meaning – no damages absent marking or notice to

the particular Ds of patent & infringement of it. Notice is an affirmative act. Must inform D of his infringement. § 287(a) notice must be of "the infringement," not merely notice of the patent's existence or ownership.

Actual notice requires the affirmative communication of a specific   charge of infringement by a specific product or de-vice. 1986 letter does not meet this standard.

D’s knowledge of the patent & infringement is irrelevant. Focus on patentee’s action, not D’s knowledge.

- Remedies Exercise (997-998)- Novelty Exercises (307-308)- Statutory Bar Exercises (246-247)- Objective Disclosure Exercises (496) (if not covered earlier)

Patent Law Outline 4/9/2023, 5:07 PM, Page 24 of 24Error! No index entries found.