AIPLA

Practical Prosecution Training for New Lawyers

August 25, 2010

Responding to Examiner’s Rejections

Denise M. Kettelberger, Ph.D., J.D. Faegre & Benson, LLP Minneapolis, MN 55402

612-766-7181 dkettelberger@faegre.com

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I. Introduction

To be eligible for patenting, an invention must meet specific criteria established in the Patent Laws (35 U.S.C.). The claimed invention must involve statutory subject matter (§ 101) that is novel (§ 102) and nonobvious (§103). In addition, the application must satisfy the statutory requirements of (§ 112). Meeting these requirements is the applicant’s responsibility. These requirements are often the basis for prior art-related and non-art-related rejections that must be overcome to gain allowance. Each requirement has a statutory basis as well as a body of case law that defines the scope of the requirement. This paper outlines the basic requirements for understanding and responding to prior art-based and non-art-based rejections during patent prosecution.

II. Non-Art Rejections

U.S. Patent Law defines what subject matter can be claimed, and how such subject matter can be claimed. 35 U.S.C. § 101 generally defines what can be claimed, while § 112 identifies claim form and how claims must relate to the disclosure of the specification.

In general, a reply to any Examiner’s non-art-based rejection should follow a generic strategy. First, consider if the Examiner’s rejection is properly made under the requirements of the statute. Has the Examiner set forth the elements required to make a prima facie showing? Is the rejection consistent with cases that have interpreted the requirement?

Second, are the facts consistent with the Examiner’s rejection? Has the Examiner missed something in the specification or misconstrued information that negates the rejection? Bringing these items to the Examiner’s attention may be sufficient to remove the rejection.

Third, look for simple solutions to the problem. A word choice, streamlining language of the claims, or other amendments may be required. Remember that every claim amendment and word change builds a prosecution history that will shape the interpretation of the claims for later enforcement and validity challenges. Be careful to consider the impact of any amendment on the total patent portfolio.

Lastly, make a complete reply to the Examiner’s allegations. In your response, state the law or rule. Consult the MPEP and cite any guidelines that fit the particular situation. Compare the Examiner’s rejection to the law, rule, and guidelines, pointing out any deficiencies. If needed, make careful amendments and discuss how the amendments overcome the rejections.

This section addresses those requirements that are not related to prior art including Sections 101 and 112, with their multiple subparts as shown in the Table below:

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A. PATENTABLE SUBJECT MATTER

35 U.S.C. §101. Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefore, subject to the conditions and requirements of this title.

The Supreme Court has interpreted subject matter that may be patented under §101 to include a broad range of inventions. See Diamond v. Chakrabarty, 447 U.S. 303, 100 S. Ct. 2204, 65 L. Ed. 2d 144, 206 U.S.P.Q. (BNA) 193 (1980). However, § 101 does have limitations. Laws of nature, natural phenomena, and abstract ideas are not per se patentable subject matter (Bilski v. Kappos, 561 U.S. ___ (2010)); however, application of these to a new and useful product or process has been found to be patentable subject matter. (Diamond v. Diehr, 450 U.S. 175 (1981)). For example, the law of gravity, naturally occurring elements or life forms, and mathematical algorithms are not patentable subject matter. However, purified or isolated vitamins, hormones, and DNA sequences, as well as methods utilizing algorithms for practical uses, are patentable subject matter.

In the recent Bilski decision handed down on July 28, 2010, a majority held only that Bilski’s patent claims to a method of hedging risk were unpatentable subject matter under Section 101 because the claims were drawn to an “abstract idea”. A concurrence by Justice Stevens agreed with the holding, but would have found all business method patents to be non-eligible under section 101. Justice Bryer’s concurrence listed four statements finding agreement among all of the justices:

Non‐art rejections 

• Patentable Subject Matter (§ 101) • Utility (§ 101) • Enablement (§ 112, first paragraph) • Written Description (§ 112, first paragraph) • Best Mode (§ 112, first paragraph) • Distinct claim language (§ 112, second paragraph) • Form of the claims (§ 112, third‐fifth paragraph) • Means plus function claims ((§ 112, sixth paragraph 

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1. § 101 is broad but not unlimited; 2. For process claims that do not include a particular machine, transformation of an

article to a different state or thing is “a clue” to patentability; 3. The machine-or-transformation test is an “important example” of how to determine

patentability but is not the “exclusive test”; 4. The former Federal Circuit’s State Street Bank test for section 101 - “useful,

concrete, and tangible result” is not the test.

The Supreme Court left other issues for the Federal Circuit to resolve, under the guidance of former Supreme Court precedent, including Gottschalk v. Benson 409 U.S. 63 (1972), Parker v. Flook 437 U.S. 584 (1978), and Diamond v. Diehr 450 U.S. 175 (1981). New decisions from the Federal Circuit applying the Bilski holding to additional sets of claims should take place over the next few years.

The U.S. Patent and Trademark Office responded to the Supreme Court’s Bilski decision with a set of interim Guidelines for Examiners to consider subject matter eligibility under Section 101. These Guidelines will be discussed in detail below.

1. Subject Matter Eligible for Patent Protection

Most patent applications will claim inventions under one of the four specific statutory classes of invention; machines (combinations of parts or devices), manufacture (articles), compositions of matter (compounds, compositions or mixtures) or processes for operating machines, making articles or compositions of matter. Exceptions include: printed matter, naturally occurring articles, scientific principles, laws of nature, physical phenomena, and abstract ideas.

a. Subject Matter Requirements

Subject matter rejections have been rare in the past, as the U.S. standard for patent eligibility has traditionally been open to all technologies. “Anything under the sun created by the hand of man” was often quoted as the standard.1 However, this open standard has been recently challenged on multiple fronts, including business method,1 electrical signal,2

1 Diamond v. Chakrabarty, 447 U.S. 303, 100 S. Ct. 2204, 65 L. Ed. 2d 144, 206 U.S.P.Q. (BNA) 193 (1980).

Non‐statutory subject matter 

• Printed matter (M.P.E.P. § 706.03(a)) • Naturally occurring articles (M.P.E.P. § 706.03(a)) • Scientific principles (M.P.E.P. § 706.03(a)) • Laws of nature (Diamond v. Chakrabarty) • Physical phenomena (Diamond v. Chakrabarty) • Abstract ideas (Bilski v Kappos) 

 

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software,3 and medical diagnostic4 process claims. The courts have challenged the process claim formats as drawn to unpatentable subject matter, for a variety of reasons, creating confusion and uncertainty in these fields.

The Supreme Court reacted to the Federal Circuit’s strict “Machine or Transformation” test of patent eligibility in Bilski v Kappos, (561 U.S. ___ (2010)) by asserting the MorT test, while helpful, is not the only test for patent eligibility. The USPTO has provided Guidelines for Examiner’s to use in examining Process claims in view of the Supreme Court’s decision.

Patent claims clearly reciting non-process categories: e.g., a machine, an article of manufacture, or a composition of matter are considered patentable subject matter, unless they claim one of the exceptions stated above, e.g., abstract idea, law of nature, naturally occurring article, algorithm. Applications may be patentable subject matter, however the “a useful, concrete and tangible result” test of State Street Bank v. Signature Financial Group, 149 F.3d 1368 (Fed. Cir. 1998) was found in Bilski not to be the correct test.

b. Processes: Post- Bilski

The Supreme Court’s holding did not provide specific guidance outside the specific hedging claims of Bilski, and suggested the Federal Circuit might devise new tests in view of the Court’s precedent, particularly in Benson, Flook, and Diehr. While awaiting the reshaping of these new tests, the USPTO’s Interim Guidance provides some instruction for navigating patent eligible subject matter during prosecution at the USPTO. See: Federal Register, Vol75, July 27, 2010: “Interim Guidance for Determining Subject Matter Eligibility for Process Claims in View of Bilski v Kappos”.

The Interim Guidance begins by noting that the Bilski court underscored that “the text of Section 101 is expansive”, and also made clear that Business Method patents are not categorically excluded from patent eligibility. Examiners are told to avoid focusing on patent eligibility issues under section 101 to the detriment of compliance with sections 102, 103, and 112, and to avoid treating an application solely on the basis of section 101. This is consistent with the Director’s focus on “Compact Prosecution”.

Process/Method claims are patent-eligible, unless they are disqualified under one of the Supreme Court’s noted exceptions: law of nature, physical phenomena, or abstract ideas. Viewing the process claim as a whole, the Examiner is instructed to determine if the claim is merely an abstract idea by applying a series of factors. The Factors are fashioned from the Supreme Court Bilski opinions, with those factors favoring patent eligibility if they satisfy the Machine or Transformation test, or provide evidence to show that an abstract idea within a claim has been practically applied. The factors are set out in the Guidance in four categories, A-D:

A. Whether the method involves or is executed by a particular machine or apparatus. If so, claims are less likely to be drawn to an abstract idea, if not, more likely. Where a machine or apparatus is recited or inherent in the claim, additional factors showing specific, useful, and meaningful description of the

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machine or apparatus in the claim may be relevant in determining if the method claim is drawn to an abstract idea despite the inclusion of a machine or apparatus:

(1) The particularity or generality of the machine or apparatus, not any and all machines

(2) If the machine or apparatus implements the steps of the method; integral use of the machine in the method or merely an object on which the method operates.

(3) If the involvement of the machine or apparatus imposes meaningful limits on the method steps or contributes only nominally or insignificantly to the execution of the steps, extra-solution activity or field of use.

B. Whether performance of the claimed method involves or results in a transformation of a particular article.

(1) The particularity or generality of the transformation.

(2) The degree to which the article is particular – not any and all articles.

(3) The nature of the transformation in terms of the type and extent of change – different function or merely having a different location.

(4) The nature of the article transformed – an object or substance versus a concept such as a contractual obligation or mental judgment.

(5) The extent to which the transformation imposes meaningful limits on the execution of the method steps - only nominally or insignificantly to the execution of the steps, extra-solution activity or field of use.

C. Whether performance of the method involves an application of a law of nature, even in the absence of a machine, apparatus, or transformation.

(1) The particularity or generality of the application – generic, broad, across many fields of endeavor, such that the claim would monopolize a natural force or patent a scientific fact, weighs against.

(2) If the method solely involves subjective determinations of the law of nature – ways to think about or react to a law of nature, weigh against.

(3) If the involvement is extra-solution activity or field of use – does the application imposes meaningful limits on the execution of the method steps or only nominally.

D. Whether a general concept (a principle, theory, plan, or scheme) is involved in executing the steps of the method. The presence of such a general concept can be a clue that the claim is drawn to an abstract idea.

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(1) The extent to which use of the concept as expressed in the method would preempt its use in other fields – grant a monopoly over the concept.

(2) The extent to which the claim is so abstract and sweeping as to cover both known and unknown uses of the concept, performed using any existing or future devised machinery, or even without any apparatus.

(3) The extent to which the claim would effectively cover all possible solutions to a particular problem – the claim is a statement of the problem rather than a particular solution to the problem.

(4) Whether the concept is disembodied or is instantiated – implemented in a tangible way. Limiting an abstract idea to one field of use or adding token post-solution components does not make the concept [patentable] patent eligible.

(5) The mechanism(s) by which the steps are implemented – observable and verifiable not subjective or imperceptible.

(6) Examples of General Concepts:

• Basic economic practices or theories (hedging, insurance, financial transactions, marketing)

• Basic legal theories (contracts, dispute resolution, rules of law)

• Mathematical concepts (algorithms, spatial relationships, geometry)

• Mental activity (forming a judgment, observation, opinion)

• Interpersonal interactions (conversing, dating)

• Teaching concepts (memorization, repetition)

• Human behavior (exercising, wearing clothing, following instructions)

• Instructing (“how business should be conducted”)

i. Avoiding Bilski rejections

Obviously, claims drafted to ensure patent-eligibility would recite machines, compositions, or articles of manufacture, avoiding process claims. In general, it has always been a good idea to include a variety of claims of different types and scope. Clearly including a particular machine or transformation as part of the process steps may also help.

For the machine prong, the machine should clearly be “special,” that is, the machine’s function should be tied to the claimed method. Reciting physical parameters of the machine that are required by the method being performed may help link the machine to the method. Performing a method on a general purpose computer or displaying results on an ordinary monitor

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might not be sufficient, but relating the method steps as manipulated by the computer to provide an outcome that is integral to the method might.

A relying solely on data transformation. Where possible, link data manipulation and transformation directly to a result, and if possible, a physical object or objects. The more tangible the transformation, the better.

To void exclusion as an abstract idea, use the Bilski factors to your advantage. The focus of the “abstract idea” inquiry generally focuses on the particularity of the claim and the relationship of the “abstract” item(s) to the implementation of the method steps. The more vague, indefinite, and abstract the claim language, the more likely to be patent ineligible. The more definite, specific, and integral to the implementation of the method steps, the less likely a claim will be excluded.

Providing clear, specific, concise, and consistent claim terminology and in the specification should be a specific goal. Provide claims with particular machines and specify transformations that are clearly appreciated from the language. Simplify claim language and particularly the preamble, taking out unnecessary language without leaving the claim indefinite. Put your active steps, results, and purpose into the method steps and take them out of the preamble. Limit “data management” steps and instead include active/physical steps showing changes in the data. Avoid trivial additions of machines or fields of use; instead show integration of machines and fields into the method.

Where the claim may be interpreted as including a law of nature or abstract idea. Pay particular attention to detailing the application of the abstract idea in a meaningful way within the claim language. The Bilski factors of particularity and meaningful limits weigh in favor of patent eligibility while generalities and trivial claim language weigh against eligibility.

c. Subject Matter

i. Prima facie Showing of Subject Ineligibility

A proper rejection for unpatentable subject matter must include a prima facie showing that the claimed invention viewed as a whole is ineligible because it is merely reciting a law of nature or abstract idea. To make such a rejection, the Examiner must weigh the relevant factors that apply to the claimed method, and make a determination of eligibility. Not every factor will be relevant to every claim. No factor is conclusive by itself, and the weight of each factor may vary with the facts of the application. The factors are not exclusive or exhaustive, and will vary with the technology and terminology of the claim.

The burden is on the USPTO to set forth a prima facie case of unpatentability. Therefore, if the Examiner rejects the claimed subject matter as ineligible for patenting the Examiner must provide an explanation, and show his/her analysis.

d. Responding to Subject Matter Rejections

A reply to a rejection for lack of eligible subject matter should first address whether the Examiner has established a prima facie case. Review the Examiner’s interpretation of the

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claims, factors, assumptions, and logic. Are these correct or seriously flawed? Has the Examiner considered the claim as a whole?

Does the invention fall within one of the statutory classes (process, machine, manufacture or composition of matter)? If the claimed invention falls within one of the statutory classes does it claim mere abstract ideas, natural phenomena or laws of nature? If the claim is directed toward a process, does it involve a machine or transform a particular article to another state or thing? If the process claim does involve a machine or transformation, is it integral to the process itself? Is the claim invention useful, does it have utility? Does the claimed invention have a “practical application” tied to the physical world?

In response to rejections asserting lack of eligible subject matter, first determine if the Examiner’s interpretation of the claims, assumptions, or logic is flawed and point out the flaws with particularity, citing the specification and other relevant evidence to establish a basis for the claimed invention being patentable subject matter.

If the Examiner prima facie case is not flawed, the burden shift to the applicant to rebut the rejection. Look for the simple solution… is the Examiner’s evidence of ineligibility related to a claim term or phrase that might be made more particular and specific? What are the particular Bilski factors used by the Examiner in the rejection, and how might each be overcome? What evidence can be used to refute the rejection?

Evidence can be offered that the claimed invention is “transformational” or produces “useful, concrete or tangible result.” Evidence can include data and discussions within the specification, extrinsic evidence, such as publications, papers declarations or Affidavits by the inventors or one of ordinary skill in the art. If the claims do not claim statutory subject matter and patentable subject matter exists within the application, the claims should be amended.

Compare similar patent claims reviewed by the Board of Appeals and Courts to align your claim language with that found to be acceptable. This will be a bit difficult for those claims “on the edge” until more guidance is provided by the Board of Appeals and Federal Circuit.

2. Utility 35 U.S.C. §101. Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof may obtain a patent therefore, subject to the conditions and requirements of this title.

Patents are granted only for “useful” inventions. Section 101 sets out the statutory classes of subject matter eligible for patent protection, and also provides a basis for the utility requirement. Machines, processes, manufacturing methods, and compositions of matter are categories of subject matter easily contemplated as “useful” in commerce. The acceptance of new types of subject matter as patent eligible, including living cells and organisms, plant varieties, and methods of doing business, demonstrate the flexibility of the U.S. Patent system to respond to a changing commercial landscape.

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a. Utility Requirements

The threshold for satisfying the utility requirement is low, but real. Some courts have called the requirement one of “practical” utility, and a standard of a “specific, substantial, and credible” utility has evolved. Utility Guidelines established by the Patent Office for compliance with the utility requirement are published in the Manuel of Patent Examining Procedure (MPEP) at §2107.

i. Guidelines for Examination for Utility

In the Guidelines, Examiner’s are directed to review the claims and written description, noting the invention set out in the claims, and any specific embodiments. After determining the claims define patent-eligible subject matter, the claims and specification are examined for disclosure of at least one utility that is specific, substantial, and credible.

Any asserted utility is presumed to satisfy the Utility requirement. Utility is a question of fact. To make a proper utility rejection, the Examiner must establish by specific evidence that it is “more likely than not” that a person of skill in the art would question or doubt the truth of the utility assertion. For example, evidence pointing to a serious flaw in the logic underlying assumptions made in the utility assertion, or evidence that the facts on which the utility assertion is based are inconsistent with the logic can help the Examiner to reject an asserted utility.

Utility can be asserted in the specification. The assertion must be specific, substantial, and credible. In some instances, the invention’s utility is so well established that no assertion is necessary, or at least, there is no need for the Examiner to investigate the criteria of specific, substantial, or credible, as these will be assumed.

The PTO Utility Guidelines recognize that some inventions are immediately recognized as having a well-established utility, for example, a new anti-bacterial agent; a new bicycle wheel and spoke configuration; a folding picnic table. The utility of some inventions is easily recognized as credible, specific, and substantial. In these cases, the Examiner doesn’t need to look further; utility is established. For other inventions, the Examiner must look for indicia that the claimed invention is credible, specific, and substantial.

Credible: The requirement of credibility is very low. The Examiner looks for any assertion that the claimed invention is useful for any particular practical purpose. Once these assertions are identified, the Examiner considers if one of skill in the art, in view of the technology, state of the art, disclosure and examples in the specification, and any other relevant materials, would consider any one of these assertions “credible.” Only one credible assertion is required.

Very few items fail the credibility test, but some do. Failure can be caused simply by the applicant’s failure to include any specific utility in the patent application, when the utility of the subject matter may not be readily known or may even be in doubt. Easy examples include cold fusion, perpetual motion machines, and time machines. More difficult examples include novel molecules, new machines, or new processes where no use is asserted at all, or where the asserted use is not supported by the specification and knowledge in the field.

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New technologies that are not proven can be found to be “incredible” utilities. At one time, the PTO held treatments for cancer and AIDS to be “incredible” utilities, and required a showing of patient treatment for utility. Gene therapy methods may be rejected as an “incredible utility,” with Examiner’s asserting actual proof in patients is required.

What might be “incredible” at the onset of a new technology era may quickly become more “credible” as data emerges and the technology becomes more reliable. For example, claims that ensued from the early studies of the human genome are sometimes rejected as incredible. Expressed sequence tags (ESTs) are small fragments of the human genome that were identified as portions of DNA expressed in humans. Research institutions filed patent applications for hundreds of these EST molecules, asserting either no function at all, a general function as encoding human proteins, or non-specific function as probes for discovering complete genes. Many of these early filings have been held to lack credible utility, as a particular practical use was not identified. Today’s genomic companies file applications where the utility of the DNA sequences is more fully developed, for example, by analogy to known sequences, or by functional assays included in the specification.

Specific: In addition to being credible, the asserted utility must be “specific” to the claimed subject matter, and not a general utility that could be applied to anything in the class of the invention. For example, an asserted use as a gene probe would not be specific in the absence of a particular target. An asserted use as a protein additive for shampoo may not be specific unless the specific protein is added for a specific purpose unique to the protein.

Assertions that the claimed invention “may be useful” in a general area, for example, useful in the treatment of disease generally, or useful in developing a new system will not be considered specific in the absence of specific indicia indicating a specific contemplated use.

Substantial: The asserted utility must be “substantial,” as well as credible and specific. A “substantial” utility is one that defines a “real world” use. In general, research use, or use in developing a product or invention may not be considered “substantial.” A substantial invention is one that is complete and ready for commercial use. Research tools may be “substantial,” for example, if they are commercially useful.

b. Utility Rejections

A proper rejection based on lack of utility must include a prima facie showing that the claimed invention lacks utility, including the Examiner’s factual evidence in support of the rejection. The rejection must contain more than a bald assertion that the invention won’t work or has no credible asserted utility. A well reasoned explanation of why no credible, specific, and substantial utility was found is required.

The Examiner’s statement must be accompanied by an evaluation of all the relevant facts, including what was disclosed in the specification and in the closest prior art. The rejection should be set forth with a clear statement of any assumptions that the Examiner has made, and any facts relied upon, in order to allow the applicant to understand the rejection and provide any available evidence to address the rejection.

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The rejection must set forth the facts and assumptions relied upon by the Examiner to support the allegation that the applicant’s logic underlying the utility assertion is seriously flawed, or that the facts on which the utility assertion is based are inconsistent with the logic.

The Examiner’s rejection may include a request that the Applicant provide additional information or data to substantiate the asserted utility. If the examiner’s evidence shows reasonable doubt regarding the utility of the invention, the burden then shifts to the applicant to provide sufficient evidence to rebut the rejection.

c. Response to Utility Rejections

A reply to a utility rejection should first address if the Examiner has established a prima facie case. Examine the Examiner’s facts, assumptions, and logic. Are these correct or seriously flawed? Are assumptions made that are not based in fact?

Is the utility of the claimed invention so well established that it doesn’t need to be spelled out? If so, cite examples of similar useful agents in comparison.

Is there a utility specifically asserted? Is it specific and not general? If so, describe the specific use and distinguish from a general consideration. A protein useful for use in hair shampoo might be considered non-specific. However, if the protein confers a specific result, such as a protein enzyme used to clean or brighten hair, the protein would then have a specific utility.

Is the asserted utility substantial? Does it have a “real world” use? Is it credible, or is it cold fusion all over again? Credibility is often an issue for new technologies, and may require confirmation. For example, gene therapy is still a new technology that is often rejected as “incredible.” Reports of successful administration of therapeutic genes and their demonstrated effectiveness in treating disease can refute the utility rejection.

A reply to the Examiner’s Utility rejection should point out with particularity where the Examiner’s facts, evidence, assumptions, or logic is flawed, demonstrated with specific factual evidence and not mere attorney opinion. The best evidence is data and discussion within the specification, supplemented where needed with extrinsic evidence, such as treatises, publications, and the like. Later published papers that confirm the asserted utility can also be provided. Declarations by the inventor(s) or one skilled in the art interpreting data or commenting on the Examiner’s evidence can also be helpful.

If the Examiner’s prima facie case is not flawed, the burden shifts to the applicant for rebuttal. Evidence or argument can be used to refute the rejection, and demonstrate that the asserted utility is true. As above, the evidence can include data and discussion within the specification, extrinsic evidence, such as treatises, publications, and the like, later papers published by the inventor(s) or others, and declarations by the inventor(s) or one skilled in the art. New data or studies that substantiate the asserted utility can be submitted by Declaration or Affidavit of the scientist performing the experiments.

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The Examiner will review all of the evidence of record in response to the applicant’s reply. On the totality of the record, the Examiner will make a final decision if one of skill in the art would more likely than not consider the asserted utility to be true or doubtful.

d. Utility Case Quotes to Consider

• A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.5

• The district court did not err in finding that the applicant’s claim to a method for enhancing the flavor of a beverage by passing it through a magnetic field was inoperative subject matter. The applicant conceded that the PTO made a prima facie case and failed to rebut that case by an expert affidavit.6

• The PTO can reject an application for insufficient proof of operability when the nature of the claimed device creates reasonable skepticism as to such operability. The PTO does not guarantee scientific theory.7

• The PTO did not err by rejecting an applicant’s claim to a “cold fusion” process for lack of utility and enablement.

. . . The utility requirement of §101 mandates that the invention be operable to achieve useful results.8

• A claimed invention need only meet one of its stated objectives to comply with the utility requirement.9

• Treating baldness was once considered an inherently unbelievable undertaking. . . . Since then, however, treatments for baldness have gained acceptance. Rogaine® (minoxidil) and Propecia® are recognized as effective in treating baldness.10

B. REJECTIONS BASED ON 35 U.S.C.§ 112, FIRST PARAGRAPH

35 U.S.C.§ 112 contains six paragraphs that set forth specific disclosure requirements that must be met to gain allowance of patent claims. The first paragraph provides the basis for the Written Description and Enablement requirements, as well as that of Best Mode.

35 U.S.C. §112 Specification The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

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1. Written Description

The first paragraph of 35 U.S.C. §112 states, “the specification shall contain a written description of the invention.” This phrase has been interpreted as an additional requirement, separate and distinct from the enablement requirement.11

a. Written Description Requirements

Written description is often asserted as a gatekeeper, assuring that the patent’s monopoly is given only in exchange for the patentee’s full disclosure of the invention. A patent applicant must demonstrate possession of the full scope of the claimed invention, and describe the invention sufficiently to also provide the invention to the public.

While there is a strong presumption that claims as filed are adequately described, newly added or amended claims do not share this presumption. Written description is commonly applied against new matter, for example, in rejecting amended claims not supported by the specification, rejecting claims in a Continuation-in-Part application as not supported by a priority application, and in an interference priority contest rejecting copied claims as new matter not supported by the patent disclosure. When amending originally filed claims or adding new claims, the location in the text of the specification of support for the amendment should be indicated to the Examiner.12

b. Deposits in Written Description

Biotechnology inventions are highlighted in the PTO WD Guidelines, perhaps because applicants in this technology fight a continual battle for adequate claim scope against multiple non-art rejections. Deposits of biological materials can be used to satisfy written description and enablement rejections, particularly when these materials are not sequenced or otherwise capable of description. The deposited material may also support correction in sequencing errors.

In contrast to deposit requirements outside the United States, the USPTO permits the deposit to be submitted post filing, during pendency of the application.13 A specific description of the deposited material must be present in the application as filed, to provide an antecedent basis and to verify that the deposited material is in fact that disclosed. “The deposit is not a substitute for a written description of the claimed invention.”14

Description of a chemical compound should be sufficiently detailed to distinguish the compound from other materials, and can be described by structure, physical or chemical properties, method of production, or other distinguishing characteristics. A description that is based only on functional characteristics such as biological activity, is generally considered “merely a wish” to know the identity of any material with that function, and is generally not sufficient description.

c. Describing a Genus

To fully describe a claimed genus, description of a “representative number” of species is needed. What number is “representative” will depend on the facts, but in general is one that

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adequately represents the genus of the claim. The specific number that must be described is a function of the variability within the genus as well as the knowledge in the art.

d. Guidelines for Examination for Written Description

Guidelines for the examination of patent applications under the written description requirement were established by the PTO and are found at MPEP §2163 (PTO WD Guidelines). The Guidelines detail the PTO’s understanding of the Court’s interpretation of the statute and the requirement and set out what an Examiner must show to make a prima facie case for lack of written description.

The PTO WD Guidelines lists some specific factors that are considered when evaluating evidence of possession and support for the claim scope. In general, any combination of these factors that identify and distinguish the claimed invention should be sufficient to demonstrate possession of the invention and satisfaction of the written description requirement.

According to the PTO WD Guidelines, describing all the limitations of a claim in words, drawings, structures, figures, or formulas, for example, can show possession of the invention. Actual reduction to practice is not required, but describing an actual reduction to practice can show possession. Acceptable evidence demonstrates to one skilled in the art that the inventor possessed the invention at the time of filing. Working examples can provide evidence of actual reduction to practice or present research steps that provide logical evidence that would be accepted in the technology field as demonstrating possession of the invention. In essence, the details of the evidence provided in the application should provide a logical and reasonably predicable path to the claim’s conclusion. Doubts or flaws in the logic leading from the evidence in the specification to the full scope of the claim will go against the patentee’s assertions of possession.

The Examiner’s prima facie case of unpatentability for lack of written description must be supported by specific findings and factual evidence that one skilled in the art would not consider the inventor to be in possession of the claimed invention. A general allegation that the claims are not described, or that the art is unpredictable, will not be sufficient to carry the burden of proof.

Written Description Factors 

• Level of skill and knowledge in the art • Disclosure of partial sequence • Disclosure of physical/chemical properties • Functional characteristics/correlation between 

structure and function • Method of making the claimed invention 

 

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MPEP §2163 directs the Examiner to read and evaluate the content of the application, including the specification, drawings, sequence listings, and the like, for compliance with the written description requirement of the first paragraph of section 112. The Examiner compares the scope of the claim with the scope of the description. From the standpoint of one of skill in the art at the time of filing, the Examiner determines if the applicant has demonstrated possession of the claimed invention. Information that is well known in the art need not be detailed in the specification. The description of the invention need not be ipsis verbis (in the same words) to comply with the written description requirement.15

For each claim, the Examiner considers:

In making a written description rejection, the Examiner must have a reasonable basis to challenge the adequacy of the written description, and has the initial burden to show with evidence or reasoning why one skilled in the art would not recognize the claimed invention as described by the application. The specific claim limitation(s) of concern are pointed out, and the reason to doubt possession are specifically enumerated. Publications including prior art and later published art can be relied upon by the Examiner to show unpredictability in the field. The presumption of adequate description must be overcome by a preponderance of the evidence.

e. Reply to Written Description Rejection

In response to a written description rejection, the Applicant should first consider if a prima facie case has been made or should be challenged. Consider if the Examiner’s statement of reasons for the rejection are specific or conclusory. Does the rejection specifically point out the limitation at issue, and set forth specific factual evidence why one skilled in the art would not accept the description as adequate? If merely conclusory, the rejection should be challenged as failing to meet the burden required.

Each specific reason for doubting the description should be analyzed for its particular basis and reasoning. Where there are faults and inconsistencies, these can be used to negate the rejection.

In many cases, the written description problem arises from the particular claim language used. A simple amendment to clarify the invention as claimed may remove an offending limitation and eliminate the written description rejection.

Written Description Guidelines 

• If actual reduction to practice is described • If a complete invention is described by specific evidence 

of possession • If the claimed invention is described by relevant 

identifying characteristics with strong correlation, for example, of structure and function  

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f. Issues with Written Description Requirement

The application or written description to reject original claims remains somewhat controversial. The Federal Circuit Court of Appeals recently denied en banc rehearing in a written description case, but the fact that several members of the court also entered forceful dissenting and concurring opinions confirms judicial dissent as to whether section 112 includes a written description requirement that is doctrinally separate from the enablement requirement set forth in the same paragraph.16

In recent years, written description has also become a powerful tool to invalidate patent claims, particularly genus claims, as containing matter not supported by the specification. A fact-specific possession test has generally been used to determine compliance with this requirement, although at least one decision has found a showing of possession alone as insufficient to cure a written description allegation.17

Evidence required to demonstrate possession of the invention is fact-specific and varies inversely with the maturity and predictability of the technology area. Inventions in “unpredictable” arts are subject to greater scrutiny under the written description requirement, and require a greater showing of possession than more predictable art units. As technology matures and becomes more predictable, a lesser showing may be required to show possession. Possession “tests” and “factors” are not clearly articulated by the Courts.

An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations.18

To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention.”19

In general, the more specific evidence of the invention found in the specification, the more likely the claim will survive a written description challenge.

g. Written Description Case Quotes to Consider:

• The continuing attack on well-established and heretofore unchallenged decisions such as Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991) (“we hereby reaffirm, that 35 U.S.C. §112, first paragraph, requires a ‘written description of the invention’ which is separate and distinct from the enablement requirement”) and earlier cases such as In re Ruschig, 379 F.2d 990 (CCPA 1967) (written description is one of three distinct requirements under 35 U.S.C. §112) is not only unwarranted, but is disruptive of the stability with which this court is charged. If precedent has become obsolete or inapplicable, we should resolve the matter as a court and again speak with one voice.20

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• The written description requirement can be fulfilled by “a precise definition, such as by structure, formula, chemical name, or physical properties.”21

• We hereby reaffirm, that 35 U.S.C. §112, first paragraph, requires a written description of the invention which is separate and distinct from the enablement requirement.22

• Moreover, it is not correct, as has been asserted, that our decisions, particularly Regents of the Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), have created a “heightened” written description requirement for biotechnology inventions. We have applied the written description requirement to cases that are not in the fields of chemistry or biotechnology.

See, e.g., In re Curtis, 354 F.3d 1347 (Fed. Cir. 2004) (dental floss); Tronzo v. Biomet, Inc., 156 F.3d 1154 (Fed. Cir. 1998) (artificial hip sockets); Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998) (sectional sofas); Lockwood v. Am. Airlines, Inc., 107 F.3d 1565 (Fed. Cir. 1997) (automated sales terminals); Vas-Cath (double lumen catheters). The statute is the same for all types of inventions, although it may be applied differently, based on the technology and what is known by one of ordinary skill in the art at the time an invention was made.23

• Following issuance, withdrawal, and reissuance of Enzo, this court engaged in lengthy debate over the new disclosure validity doctrine. Enzo Biochem, 323 F.3d at 971-75 (Lourie, J., concurring in decision to not hear the case en banc); id. at 975 (Newman, J., concurring); id. at 975-76 (Dyk, J., concurring); id. at 976-87 (Rader, J., dissenting); id. at 987-89 (Linn, J., dissenting).

That debate continued in this court’s subsequent cases. See, e.g., Moba B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1323 (Fed. Cir. 2003) (Rader, J., concurring) (explaining that juries face the “cumbersome task” of deciding that “the patent’s disclosure can enable a skilled artisan to make and practice the entire invention, but still not inform that same artisan that the inventor was in possession of the invention”).24

2. Enablement

The first paragraph of 35 U.S.C. §112 requires that the specification contain a written description that is sufficient to “to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.” Enablement and written description are asserted by the courts and by the PTO as separate and distinct requirements of 35

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U.S.C. §112, first paragraph. While written description requires the disclosure to demonstrate possession of the invention by the inventor at the time of filing, enablement requires a description sufficient to teach how to make and use the claimed invention.

The amount of description necessary to enable one of skill in the art to make and use the invention depends on the technology of the invention, its predictability, maturity, and complexity. The invention may be one where disclosure of the invention alone is sufficient to permit one to make and use it, for example, a software invention where a flow chart showing the functional steps enables an engineer to make the invention in any number of different ways. Disclosure of the specific code isn’t necessary unless it is claimed with particularity and must be described to support a specific claim. Similarly, disclosure of a protein sequence is sufficient to enable a skilled person to make and use a variety of different nucleic acid sequences encoding the protein, and the particular nucleic acid sequences need not be disclosed, unless a particular nucleic acid sequence is claimed with particularity and must be described to support a specific claim. Thus, the claim strategy and terminology are determining factors in the amount of disclosure required to enable the claimed invention.

a. Enablement Requirements

The test for determining if a claim meets the enablement requirement is demonstrated in the question: Is undue or unreasonable experimentation needed to practice the claimed invention? The specification must teach how to make and use the invention without undue experimentation. Factors used to determine if experimentation needed to practice the invention is “undue” include the following “Wands factors”:

Analysis of undue experimentation using these factors focuses on all of them, and not just any one. In practice, the question is one of predictability: Does the teaching of the specification in view of what is known in the art and by one skilled in the art more predictably than not enable one to make and use the claimed invention?

Wands factors for determining enablement25 

• Breadth of the claims • Nature of the invention • State of the prior art • Level of ordinary skill in the art • Predictability of the art • Amount of direction provided in the specification • Any working examples • Quantity of experimentation needed relative to the disclosure 

 

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i. How much disclosure

An application must contain a sufficient enabling description that teaches how to make and use the claimed invention. The application does not need to disclose what is well known, but must provide a specific teaching of what is not well understood or known. The application also does not need to enable one skilled in the art to make and use a commercially viable embodiment.26 Materials needed to practice the invention, particularly starting materials that are difficult to obtain or to make, should be described with particularity. For example, a particular antibody, a machine of particular accuracy, or a specific chemical not easily made, that is required to make or use the claimed invention need to be described in sufficient detail or otherwise provided by reference or even deposit. Enablement also requires teaching of how to use a claimed compound or composition for the utility asserted in the specification.

Reduction to practice or actual working examples are not required for enablement, but are factors to consider. Where there is no working example, enablement can be made by correlation of what is disclosed with what is known. For example, for claims to a compound for treating cancer, disclosure of in vitro examples demonstrating the ability of the compound to arrest growth of cancer cells should be sufficient to correlate the use of the compound in the treatment of cancer.

ii. How much to claim

Claiming the invention broadly to fully protect the invention causes additional enablement issues. The PTO WD Guidelines assert that a single species may be sufficient to enable the claimed genus, but that a “representative” number of species is required. How many species are representative of the claimed genus can be assessed using the Wands factors for undue experimentation.

b. Examination

To analyze claims for enablement, the Examiner will first construe the claim terms. Claim terms are defined in view of the specification and understanding in the art. The scope of the claim is also construed. Enablement is assessed for the full scope of the claims. Features of the invention described in the application as “critical” or “necessary” will be required in the claims. Preferred or exemplified embodiments are not essential to the claims. Inoperable embodiments, generally excluded by claim language, may be permitted, unless the Examiner asserts undue experimentation would be required to make and use operable embodiments of the claimed invention.

To make an enablement rejection, the Examiner has the initial burden to establish a reasonable basis to question the enablement provided in the application. Unless there is a reason to doubt the objective truth of statements made in the application, they are presumed to satisfy the enablement requirement.27 At minimum, an enablement rejection must give specific reasons that cause the enablement to be uncertain.

The Examiner analyzes the Wands factors and all the evidence as a whole in considering the enablement issue, but the rejection might focus only on those factors that lead to the conclusion of non-enablement. The Examiner will identify what specific facts and factors are

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missing, inconsistent, or otherwise undermine enablement. Often, the Examiner will conclude that a specific scope of the claims is enabled, while the full scope is not. Specific reasons must be given why the Examiner doubts one skilled in the art would not know how to make and use the full scope of the claims in view of the disclosed embodiments.

c. Reply to Enablement Rejection

In reply to an Examiner’s rejection for lack of enablement, the logic and consistency of the Examiner’s facts and statements should be reviewed for accuracy or flaws. If the basis for the rejection is flawed, no prima facie case is made and the rejection must fail.

If the Examiner’s rejection is not seriously flawed, the burden shifts to the applicant to refute the Examiner’s rejection. Everything within the scope of the claims must be enabled. Any evidence that the disclosure as filed enables the claimed invention can be used to refute the rejection, including evidence within the Wands factors, prior art, and later completed studies can be used. Declarations of the inventor or others are useful to enter this new information into the record. Such declarations might be used, for example, to explain conflicting evidence asserted by the Examiner, or to describe completion of hypothetical examples provided at the time of filing. The data submitted should correlate to what was disclosed in the application, and can demonstrate that one skilled in the art, following the directions given in the application at the time of filing, can make and use the full scope of the claimed invention.

In some instances, a “blind” group of skilled persons in the art is provided with only the application and asked to make and use the invention. A declaration by one skilled in the art demonstrating use of only the application and knowledge of one in the art to successfully make and use the invention can be good evidence of enablement.

If references were cited to show uncertainty in the field, a review of the art might show otherwise. A collection of references in the prior art showing inconsistent results might be explained in another prior article, or might be distinguished on the specific factual basis of the study. Looking at the contemporaneous art as a whole, and recognizing when the art might have understood things one way early on, but was later proven wrong can turn the rejection around. If the art is reviewed and cited to the Examiner, don’t be selective and send in only the art that supports your position. All the new art should be cited, and where there is an inconsistency with your position that is readily explained, it should be distinguished.

Once all the evidence to counter the Examiner’s rejection is marshaled, it should be provided to the Examiner in a clear and organized manner, generally in the order the rejections were made. The Examiner will reconsider the enablement issue considering the totality of the evidence, reweigh the Wands factors and others, and again determine if one skilled in the art would be able to make and used the invention based on the disclosure provided. The threshold for enablement is low: the evidence need only be “more likely than not” considered true.

As in any response, avoid inserting new definitions, description, or inconsistent material into the record. The reply should focus on the Examiner’s rejections and answer each one using the words found in the specification. If a Declaration is submitted, it should be limited to the scope of the rejection and the specific evidence, using the terminology and scope of the

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disclosure. The reply may also argue enablement using the Wands factors and other indicia of predictability.

Claim amendments to clarify terminology and scope or otherwise remove non-enabled embodiments should be carefully constructed and argued. Narrowing the scope of the claims and defining the terminology encompassed in the claims by argument will estop enforcement beyond the admitted scope of the amended and argued claims.

d. Uncoupling Enablement from Written Description

One example of how the courts find a claim adequately enabled but not adequately described is the famous Lilly insulin case.28 The description taught how to make and use various species of insulin, by hybridizing any unknown species DNA to the disclosed rat species DNA. Specific claims to human and vertebrate DNA encoding insulin were rejected as lacking written description. While one of skill in the art could have made and used human, vertebrate, or any type of insulin using the disclosed rat insulin as a probe to obtain the others, the actual claimed sequence was not in the inventor’s possession at the time of the invention and was a “mere wish.”29

The Lilly case is also a good example of how the maturity of an “unpredictable” art can change with time. The technology disclosed in the Lilly patents was 1980’s biotechnology that has now been validated and made more predictable. Having a single species DNA encoding a novel functional protein today enables one skilled in the art to make and use homologous DNA encoding variants of that protein in virtually any species. The question of whether a particular species is adequately described to show possession is still unanswered, but likely will require a particular description.

e. Enablement Case Quotes to Consider

• What is claimed by the patent application must be the same as what is disclosed in the specification; otherwise the patent should not issue.30

• Enablement is not precluded even if some experimentation is necessary, although the amount of experimentation needed must not be unduly burdensome.31

• The enablement requirement is met if the description enables any mode of making and using the claimed invention.32

• Although not explicitly stated in section 112, to be enabling, the specification of a patent must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.

Because the applicants disclosure does not teach a person having ordinary skill in the art how to make an IGBT that acts as a transistor ‘at all times’, the most we can credit them with is having predicted - rather than invented - such a device.33

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• The district court properly held invalid for want of enablement the patentee’s generic claims to all possible genetic sequences that have activity resembling that of the specific DNA sequence encoding for a protein the patentee discovered.34

3. Best Mode

35 U.S.C. §112 states the specification “shall set forth the best mode contemplated by the inventor of carrying out his invention.” The best mode requirement prevents inventors from obtaining a monopoly in exchange for disclosure of the invention, while keeping to themselves the best embodiment. Full disclosure of what the inventor believed to be the best mode for making and using the invention is required. The best mode includes each feature of the invention as claimed. Best mode might include the best starting material, the best heating temperature, the best promoter to operate the DNA expression, the best data analyzer, best reagent supplier, and the like.

Compliance with the best mode requirement is difficult to determine, and is generally presumed at the Patent Office level. Intense discovery during the enforcement of the patent may provide a defendant with a best mode reason to render the patent invalid and unenforceable. Full disclosure should be made at the time of the invention to protect the investment in the patent. While the best mode for carrying out the invention must be disclosed in the application, it does not need to be particularly noted as the best mode. For example, in a chemical case providing many derivative compounds as useful in the invention, the best candidate need not be specifically identified. Comparative functional data for the compounds can be shown as meeting a desirable threshold instead of showing the actual data, thus not showing the particular lead compounds that showed highest activity. This strategy is risky however, as the comparative data might not be available to distinguish preferred compounds, for example to overcome prior art that may be found by the Examiner.

a. Best Mode Requirement

The application must disclose the best mode known to the inventor at the time of the invention. However, many times the inventor is not aware of one mode being any better than another at the time of the invention. No best mode is required to be disclosed when there simply isn’t one.

There is no requirement to “update” the best mode in a U.S. filing of a counterpart non-US priority document. No update is required when filing a U.S. Continuation or Divisional application, however, updates are required in Continuation-in-Part applications.

b. Best Mode Rejection

The Examiner can make a rejection for failure to disclose the best mode, if it is determined that the inventor knew of a mode of practicing the claimed invention that the inventor considered to be better than others. Commercial modes, alternative modes, and the like may not rise to the level of the best mode. The determination is determined by the thinking of the inventor at the time of the application. Evidence of concealment or withholding is difficult to obtain during ex parte prosecution. If the Examiner finds such evidence, the application is

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examined to determine if one skilled in the art is enabled to practice the best mode with the disclosure provided.

c. Reply to Best Mode Rejection

Reply to a best mode rejection is necessarily fact-specific. The evidence provided should be considered against the inventor’s determination of what, if anything was considered the best mode at the time of filing and why. Often at the time of filing, alternative embodiments are available, but not fully tested to determine which is the best mode for practicing the invention. Each embodiment may have a particular feature not present in the other that could be considered “best.” If all known modes are disclosed and not concealed, a best mode rejection cannot stand.

The best mode requirement is unique to the United States patent system. When filing U.S. counterparts of non-U.S. applications, the inventors should be queried as to the best mode contemplated at the time of U.S. filing. If the best mode at the time of filing the priority document was not disclosed, the application can be amended to insert the best mode in compliance with the requirement.

d. Best Mode Case Quotes to Consider

• Invalidity or violation of the best mode requires intentional concealment of a better mode than was disclosed. That which is included in an issued patent is, ipso facto, not concealed.35

• Whether the best mode requirement is met depends on the scope of the invention, the skill in the art, evidence as to the inventor’s belief, and other surrounding circumstances.36

C. REJECTIONS BASED ON 35 U.S.C.§ 112, SECOND PARAGRAPH

The second paragraph of 35 U.S.C. §112 directs specific requirement for the form of the claims:

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.

1. Distinct Claiming Requirement

Two specific requirements are found in this paragraph; that the claims set forth the subject matter claimed as the invention, and that the claims distinctly define the limits of the subject matter protected by the claims. The first depends on what the applicant believes the subject matter of the invention to be; the second depends on the clarity of the claim language to one skilled in the art.

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2. Claim Language Objections and Rejections

The Examiner determines if the claims are precise, clear, correct, and unambiguous. Any uncertainties in claim language or scope should be objected to and clarified during prosecution.

A rejection based on the failure to claim what the applicant regards as the invention arises, for example, when the claims are inconsistent with what the applicant has stated elsewhere, for example in a later published paper commenting on the same invention, admissions in corresponding cases, in briefs submitted to courts, and the like. Absent such specific contrary evidence, the claims are presumed to set forth what the applicant regards as the invention.

This requirement does not mean that the applicant can’t change what they believe the invention to be during the course of prosecution. For example, the claims may be narrowed in the original case; a continuation or divisional application might focus on a different invention than the original claims.

Rejections based on lack of distinct and clear claim language are made to ensure that the boundaries of the claims are well understood by the public, as well as by the Examiner during prosecution. Patentees can be their own lexicographers, and can define the invention in their own words, as long as the words are not contrary to what is accepted in the art. Functional language, negative limitations, alternative expressions, and other stylistic features can be used, as long as the claim boundaries are clear.

The threshold of the distinctiveness requirement is if the claim language is reasonably clear and precise. The Examiner should not require his or her preferred claim language or reject the claims for simple preferences, but can suggest terms or changes that might make the claims more clear. Definiteness of the claim language is viewed with the application, the prior art, and the meaning of the terms to one of ordinary skill in the art. The claim is considered in its entirety. If the claim language does not permit one of skill in the art to determine the boundaries of the claim, a rejection is made.

The MPEP cautions against application of per se rules of indefiniteness, and suggests that where the Examiner would like to suggest alternative language for better clarity, a rejection should not be made. The suggestion can be made, but the applicant can choose not to accept the suggested language.

Despite the caution against per se rules, some types of claim terms introduce indefiniteness into the claims. Words such as “about,” “substantially,” “essentially,” “similar,” “homologous,” “type,” “relatively,” “comparable,” “suitable,” and others that require reference or relativity may not be accepted as definite and clear. Other ambiguous terms that often are rejected include “effective amount,” “sufficient amount,” and the like. These terms may be defined in the specification to have defined limits, and to remove ambiguity. The phrases “for example” and “such as” are generally not permitted in the claims. Failure to provide antecedent basis for later terms proceeded by “the” or “said” should be corrected in keeping with conventional claim construction methods.

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3. Reply to Claim Language Objections and Rejections

In reply to a definiteness or clarity rejection, it is often best to amend the claims to more clearly and precisely define the invention. Often the lack of clarity enters into the claim because of excess wording. Streamlining the claim language can provide not only a clearer claim, but often a claim of broader scope.

Prior to making any claim amendments, however, the impact of the change on any other patents in the family, the ability to use terms described in the specification, and the impact on the scope of the claim should be considered.

If the terms are well defined or otherwise clear to those of skill in the art, a showing of use in the art can obviate the rejection. In the end, both the Examiner and the Applicant should focus on how the claim language will be interpreted by the public seeking to avoid infringement and by the court seeking to enforce the claims.

4. Claim Language Quotes to Consider

• The specification and claims of a patent constitute one of the most difficult legal instruments to draw with accuracy.37

• It is the applicants’ burden to precisely define the invention, not the PTO’s. 38

• The purpose of the claims is not to explain the technology or how it works, but to state the legal boundaries of the patent grant. A claim is not ‘indefinite’ simply because it is hard to understand when viewed without benefit of the specification.39

D. AFFIDAVITS AND DECLARATIONS

Applicants may submit evidence to the Examiner via an Affidavit or a Declaration when the evidence may not fall within another patent rule. The Affidavit (notarized) or Declaration (not notarized) is a sworn statement by an inventor or other party, averring to the truth of the matters stated, and providing evidence that may be material to the examination of the claims. Recent changes to the Patent Rules allow the Applicant to submit such evidence in a sworn Declaration without the necessity of a notary’s witness.

In general, two patent rules permit the use of Affidavits/Declarations: 37 C.F.R. § 1.132 permits the Applicant to submit new evidence into the record to traverse a rejection raised by the Examiner. 37 C.F.R. § 1.131 permits the Applicant to provide evidence of invention prior to the effective date of a reference cited under 35 U.S.C. § 102 (a) or (e). Each document serves a different purpose, but the format is similar.

E. CONCLUSIONS

These guidelines and tips should help the practitioner respond to a non-art rejection. However, responding to non-art rejections is a skill acquired only with much practice. Consult with experienced colleagues as you learn the art of responding to non-art rejections.

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III. Prior Art-Based Rejections

U.S. Patent Law dictates that, in order to be eligible for patenting, an invention must be novel and non-obvious over what was known prior to the invention, the "prior art". There are two basic prior art rejections: lack of Novelty and lack of Obviousness. A Novelty rejection under 35 U.S.C. § 102 asserts the invention is fully disclosed in a single prior art reference. A rejection based on Obviousness under 35 U.S.C. § 103 asserts the invention is either found by combining multiple prior art references, or otherwise would be obvious to one of ordinary skill in the art based on available knowledge, art, and “creativity”.

Prior art, as discussed below, comes in many forms, including patents, applications, and non-patent literature, as well as admissions and pre-filing actions of the patent applicant. Remember, that any cited prior art must enable the making and using of the claimed invention, and not merely name or describe the subject matter if it can't be produced without undue experimentation.

In planning a response to a prior art rejection, a good understanding of the invention as claimed, including full scope and recited limitations, is essential. The Examiner’s rejection should be reviewed with the cited art as a whole, making an independent assessment of the prior art's disclosure as compared with the claimed invention.

In this section, we will discuss the many different types of statutory prior art rejections under 35 U.S.C. § 102 and § 103, including various types of prior art and caveats. We’ll discuss the basic case law that provides the foundation of the statutory requirements and defines the application of the law to the words of the claims. Finally, we will provide approaches for responding to various types of prior art rejections.

A. NOVELTY - 35 U.S.C. § 102

A proper novelty rejection under 35 U.S.C. § 102 will include a single prior art reference that discloses every claim limitation of the rejected application.2

1. 35 U.S.C. § 102 - Conditions for patentability; novelty.

A person shall be entitled to a patent unless -

(a) the invention 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 thereof by the applicant for patent, or

(b) the invention was patented or described 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 the application for patent in the United States, or

2 Acromed Corp. v. Sofamor Danek Group, Inc., 253 F.3d 1371, 1383 (Fed. Cir. 2001); Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548 (Fed. Cir. 1983).

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(c) he has abandoned the invention, or

(d) the invention was first patented or caused to be patented, or was the subject of an inventor's certificate, by the applicant or his legal representatives or assigns in a foreign country prior to the date of the application for patent in this country on an application for patent or inventor's certificate filed more than twelve months before the filing of the application in the United States, or

(e) the invention was described in - (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for the purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language; or

(f) he did not himself invent the subject matter sought to be patented, or

(g)(1) during the course of an interference conducted under section 135 or section 291, another inventor involved therein establishes, to the extent permitted in section 104, that before such person's invention thereof the invention was made by such other inventor and not abandoned, suppressed, or concealed, or (2) before such person's invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it. In determining priority of invention under this subsection, there shall be considered not only the respective dates of conception and reduction to practice of the invention, but also the reasonable diligence of one who was first to conceive and last to reduce to practice, from a time prior to conception by the other.

a. First to Invent and Statutory Bar (one year)

In the highlighted sections above, note that some of the definitions of prior art are measured against the date of invention (§ 102(a),(e)), while others are measured by a one year "statutory bar" (§ 102 (b),(d)). In contrast to the rest of the world, U.S. patents are awarded to the "first to invent". Proof of invention prior to the cited art can be used to overcome novelty rejections under § 102(a) and (e). Prior invention is not sufficient to overcome the statutory bars imposed by § 102(b) and (d), however. These sections set a one year maximum date prior to the filing date of an application for claiming prior invention.

b. Publications, Patents, Use, Knowledge, Sale

Different types of prior art are defined in § 102. Basically, prior art includes any disclosure of the invention that occurred before the invention date and/or date of filing an application for patent (critical date). The principle is simply that something already in the public domain is not eligible for patenting. Evidence that the invention was in the public domain can take a variety of forms.

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A printed publication dated prior to the critical date is one example. The date of the printed publication, however, is not always the date shown on the document, but can be earlier or later, depending on the date it was available to the public. The date of public availability can be evidenced, for example, by a library's date of receipt stamped on the journal cover, a mailing label or delivery receipt, the journal's log of when the copies were mailed from the publisher's office, a date stamp from a computer screen showing the date viewed and content. Today many journals make abstracts and whole journal articles available to subscribers online, pushing the date of public availability sometimes a month or more prior to the date on the printed articles. Numerous telephone calls to publishing houses to establish these dates have developed a service industry by the publishers, who now extract a small fee for confirming dates.

What constitutes a "printed" publication? This phrase is redundant with the advent of technology for dissemination, duplication, electronic storage and retrieval of information. As early as 1981, one court concluded: "...interpretation of the words 'printed' and 'publication' to mean 'provability of dissemination' and 'public accessibility' respectively, now seems to render their use in the phrase 'printed publication' somewhat redundant."3

The key to "publication" is a combination of dissemination, availability, and accessibility to the public. For example, database printouts of abstracts that themselves were not prior art publications, were properly relied upon to as evidence that software products referenced in the printed abstracts were first installed or released more than one year before applicant's filing date.4

The patent applicant's own admissions identifying the work of another, for example, in the background section of the patent application or in other publications, can similarly serve as prior art. The principle of this is that the disclosure admits prior knowledge of the work of another. For example, acknowledgement of a non-inventor coworker's work in a patent application can be construed as prior art against claims asserted in the application. As discussed below, recent Supreme Court dicta in the KSR Intern. Co. v. Teleflex Inc., 127 S.Ct. 1727 (2007) holding suggests the background section of many patent applications describing events leading to an invention may be fodder for admissions useful to invalidate patent claims as "obvious to try".

Patents and published patent applications can be prior art as printed publications. Patents and applications can also constitute prior art effective on the date of filing, to provide evidence of knowledge prior to the invention date of the applicant. This will be discussed more fully below.

For purposes of § 102, prior art based on the use, knowledge, or sale of an invention is limited to use, knowledge, or sale in the United States. The use or knowledge must be public, and evidence provided as to the date and public availability. Use or knowledge obtained under a confidentiality agreement, for example, would not constitute prior art. The sale can be a definite sale or an offer to sell. The invention offered for sale must be "ready for patenting" and the offer must be for a commercial purpose and not primarily for experimentation. The sale or offer to sell need not be public.

3 In re Wyer, 655 F.2d 221,226, 210 USPQ 790 (CCPA 1981) 4 In re Epstein, 32 F.3d 1559 (Fed. Cir. 1994)

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As used in § 102, the term "other" or "another" refers to any entity that differs from the inventive entity of the patent application. A difference of only one named inventor is sufficient to be "another" and classify the reference as prior art.

c. Prior Art Defined

Generally speaking, prior art includes "...knowledge that is publicly known, used by others, or available on the date of invention . . . .”5 35 U.S.C. § 102 subsections (a) (b) (e) and (g) specifically define what can be prior art, for use in determining both Novelty under § 102 and obviousness under 35 U.S.C. § 103. In other words, to qualify as prior art that can be cited against patentability at the USPTO, an art reference must fall within the listed criteria of § 102 (a) (b) (e) or (g) as discussed below.

2. Rejections Under 35 U.S.C. §§ 102(a) & (e)

Prior art rejections based on 35 U.S.C. §§ 102(a) and (e) assert the art was available prior to the invention thereof by the patent applicant.

a. 35 U.S.C. § 102(a) - Known, Used, Patented, Published Before Invention

Section 102(a) provides that applicant is entitled to a patent unless….., before the invention thereof by the applicant, the claimed invention was:

(1) Publicly known or used by others in the United States or

(2) Patented or described in a printed publication in any country.6

Prior art for purposes of § 102(a) is measured against the “date of invention” by the applicant. In general, an examiner assumes the first filing date (priority date) is the “date of invention”. The patent applicant can assert an earlier invention date to avoid the reference, for example by submitting an antedating declaration with evidence of possession of the invention at an earlier date.

In practice, a rejection based on § 102(a) applies art dated only within one year prior to the application’s filing date. This is because art filed more than one year before the filing date qualifies as a statutory bar under § 102(b), as discussed below.

i. Domestic Inquiry – “Known or Used by Others”

To qualify as prior art under § 102(a), knowledge or use of an invention by others before the date of invention is limited to knowledge or use in the United States.7 In addition, the prior

5 Black’s Law Dictionary, 119 (8th ed. 2004). 6 35 U.S.C. § 102(a) (2007). 7 35 U.S.C. § 102(a).

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knowledge or use must be public.8 What constitutes "public" knowledge or use can vary with particular facts and circumstances. In practice, factors such as the extent of public exposure to the knowledge or use, the public forum, the relationship of the witnesses, availability of the public knowledge or use, and the like will contribute to a decision of the public nature of the prior knowledge or use.

For example, private knowledge of four individuals relating to a tractor pull sled was held not sufficiently "public" knowledge.9 The term “public use” was more liberally construed, for example, in Rosaire v. Baroid Sales Division, National Lead Co., finding an invalidating public use of a method of oil prospecting that was witnessed only by a small number of individuals, because the patent applicant made no effort to keep the use of the method secret.10

ii. Global – “Patented or Described in a Printed Publication”

Section 102(a) also prohibits the patenting of an invention that already patented in another country or described in a publication in the U.S. or any other country published before invention by the patent applicant.11

As discussed above, key to the determination that a publication is qualifying prior art is the date of publication, availability, and accessibility to the public. Note that a printed publication can be prior art even when availability of the publication is relatively low.12 For example, a single copy of a dissertation, correctly indexed in a single library open to the public may be sufficiently public under § 102(a).13 Note the prior art publication need only be accessible to the public; the Examiner need not show that it was available to the patent applicant.

Prior art can be "public" if it is available to at least one member of the general public. Material published in periodicals, like magazines, is effective as of the date it was published, e.g., provided to the members of the public, not when the material first gets to the publisher.

8 See, e.g., Bennett Regulator Guards, Inc. v. Canadian Meter Co., 184 Fed. Appx. 977, 980 (Fed. Cir. 2006); Woodland Trust v. Flowertree Nursery, 148 F.3d 1368, 1370 (Fed. Cir. 1998) (“...in order to invalidate a patent based on prior knowledge or use, that knowledge or use must have been available to the public.”); National Tractor Pullers Ass’n v. Watkins, 205 U.S.P.Q. 892, 911 (N.D. Ill. 1980) (“Prior knowledge as set forth in 35 U.S.C. §102(a) must be prior public knowledge, that is knowledge which is reasonably accessible to the public.”). 9 National Tractor Pullers Ass’n, 205 U.S.P.Q at 912. 10 Id. 11 35 U.S.C. § 102(a). 12 See, e.g., Jockmus v. Leviton, 28 F.2d 812, 813 (2nd Cir. 1928) (indicating that a single copy of a publication in a library may act as prior art); In re Hall, 781 F.2d 897 (Fed. Cir. 1986) (holding that a single copy of a dissertation, correctly catalogued and publicly available in a University library, suffices to meet the “printed publication” language of § 102(b)). 13 Jockmus, 28 F.2d at 813.

Domestic vs. Global Inquiry

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b. Described in Application Filed Before Invention 35 U.S.C. § 102(e)

Like § 102(a), § 102(e) also determines prior art according to the applicant’s date of invention. This section provides that an inventor is entitled to a patent unless the invention was described in a published U.S. application or in a U.S. application that results in a U.S. patent, where the application is filed by another in the U.S. before applicant’s invention date.14 Note that international applications filed under the Patent Cooperation Treaty (“PCT”) that designate the United States and are published in English, for purposes of this section, are treated as U.S. applications.15

Subject matter described in the specification of U.S. patents and applications, as well as the claims, can be prior art under 102 (e).16 A published patent application can qualify as prior art against subsequently filed applications even if the application fails to result in an issued patent.17

Under § 102 (e), claims can be rejected on the basis of prior art that was not available to the public at the time of filing. When a pending patent application disclosing the invention is published at 18 months from its priority date or is granted as a patent, it becomes prior art effective as of the application's filing date.

For example, Inventor A filed an application for a patent covering invention X on July 1, 2006. Before filing, Inventor A conducted a thorough search for prior art and believed there were no references anticipating the invention. Unbeknownst to Inventor A, Inventor B filed a patent application disclosing invention X on January 1, 2006. When Inventor A filed, Inventor B’s application was secret and had not been published. Eighteen months after Inventor B’s priority filing date, July 1, 2007, Inventor B’s application published. Inventor B's application is prior art against Inventor A’s application, effective on its filing date, January 1, 2006. The fact

14 35 U.S.C. § 102(e) (2007). 15 PCT applications become prior art under § 102(e) when they enter the “national stage” in the U.S. This date may be later than the international filing date of the PCT application if the application is not published in English. 16 Alexander Milburn Co. v. Davis-Bournonville Co., 270 U.S. 390, 401 (1926) (holding, under predecessor statute to § 102(e), that a patent application pending when a subsequent application is filed can act as prior art against the subsequent application). 17 §102(e) was amended such that disclosures in a patent application constitute prior art provided that the application either issues as a granted patent or is published pursuant to § 122(b).

 Patents or publications can be prior art regardless of where they originate;  Public use and knowledge must be established in the U.S.  

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that Inventor A had no way of finding Inventor B’s application carries no weight. See Figure 1, below.

Note that the requirements of § 102(e) apply to applications that are filed in the U.S. only, with the caveat that PCT applications designating the U.S. and published in English are considered U.S. patent applications under this section.

3. 35 U.S.C. §§ 102(b) & (d) - Statutory One-Year Bars

The statutory bars to patentability delineated in §§ 102 (b) and (d) require inventors to file patent applications within one year of publication of the invention, whether the publication is by the inventors or by others. Unlike date of invention considerations of §§ 102(a) and (e) discussed above, §§ 102(b) and (d) set a statutory time limit one year prior from the application's the priority filing date. Any prior art disclosing the claimed invention in a patent, publication, in use, on sale, or contained in a U.S. patent application more than one year prior to the filing date of the invention effectively bars patentability of the disclosed invention. Under these sections, an inventor can be barred from obtaining a patent even the first to invent what is claimed, because the inventor or another disclosed the invention more than one year prior to filing.

Note that the one year bar provided in these sections contrasts with absolute novelty bars that exist in most non-U.S. patent laws. In other countries, the publication of the invention even one day prior to the filing date serves to bar patentability of the invention. Recall that the United States issues patents to the first to invent, whereas the rest of the world issues patents to the first to file. These distinctions are ripe for change as the United States considers patent reforms aimed to harmonize patent laws worldwide, reduce the patent application backlog, and improve patent quality in the United States.

a. Public Use and On Sale Bars Under 35 U.S.C. § 102(b)

Section 102(b) states that a person is entitled to a patent unless “the invention was patented or described in a printed publication in this or a foreign country or in public use or on

Inventor B invents X, files patent application

Inventor A invents X, files patent application

01/01/2006 07/01/2006 07/01/2007

Figure 1: Though Inventor B’s application did not publish until a full year after Inventor A filed her patent application, Inventor B’s application acts as prior art against Inventor A under § 102(e).

Inventor B’s application Publishes

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sale in this country more than one year prior to the date of application for patent in the United States . . . .”18

The first two categories of prior art for § 102(b), patents and printed publications, qualify as prior art in much the same way as patents and publications under § 102(a). As discussed above under § 102(a), “public use” must be accessible and available to the public, with various factors contributing to a determination of whether use is indeed public. Even a single use by an individual other than the inventor might constitute a public use when the single use is visibly commercial in nature, whereas use by several close family and friends may not.19

Subject matter that is “on sale” under § 102(b) is prior art against an applicant where the invention is “on sale” more than a year before an application was filed.20 An invention is “on sale” when it is the subject of a commercial offer for sale and when the invention is "ready for patenting".21 There is no requirement in § 102(b) that the invention be reduced to practice or otherwise perfected to be on sale as required by the statute.22 In Pfaff v. Wells Electronics,23 for example, the Court found that an offer relating to a socket for holding computer chips was “on sale” when its conception was complete, even though a working model of the socket had not been made when its inventor offered to sell it.24

b. Foreign Filing Bar Under 35 U.S.C. § 102(d)

Section 102(d) makes any foreign patent prior art provided the patent issues before the U.S. application's filing date, covers the same invention, and the applicant applied for the foreign patent more than one year before filing the U.S. application.25 This becomes a practical issue, for example, in those countries that do not examine patent applications, but simply register the patent after filing. Reasonable efforts to file U.S. applications should be made as soon as possible after filing any foreign applications, as registration countries may grant patents after only a short period of time.

18 35 U.S.C. § 102(b) (2007). 19 In re Smith, 714 F.2d 1127, 1134 (Fed. Cir. 1983) (A public use is “any use of [the] invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor.”). But see Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261 (Fed. Cir. 1986) (holding that inventor of Rubik’s Cube-type puzzle’s sharing of a prototype with friends and coworkers did not amount to a public use). 20 35 U.S.C. § 102(b). 21 Pfaff v. Wells Electronics, Inc., 525 U.S. 55, 67 (1998). 22 Id. at 60. 23 Id. 24 Id. at 67. 25 35 U.S.C. § 102(d) (2007). See also MERGES & DUFFY at 635 (“It might be better to view § 102(d) as requiring three things, in this order: (1) same invention, (2) a foreign application filed more than twelve months before the U.S. filing, and (3) a foreign patent issued before the U.S. filing.”).

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4. 35 U.S.C. §§ 102(c), (f), and (g) - Loss of Right

Additional §§ 102 involve loss of rights for abandoning the invention (§102(c)), not being the inventor of the subject matter sought to be patented (§102(f)), or establishing via an interference that another inventor was first to invent (§102(g)).

B. RESPONDING TO REJECTIONS UNDER 35 U.S.C. § 102

A rejection under § 102 is proper only if each limitation of the rejected claim is anticipated by a single prior art reference.26 In making a rejection under § 102, the examiner will set for the statutory basis of the rejection (§ 102 (a)-(e)) and the cited art. The particular portion of the reference supporting the examiner’s understanding of why the reference teaches all elements of the rejected claims will be provided.

Faced with one or more rejections under § 102, what do you do first? Before taking any action, carefully read all rejections and cited prior art in order to understand each in light of the claims before responding. Identify the references cited against the rejected claims, understand how and why the examiner has applied those references to the rejected claims, and determine if each reference does, in fact, act disclose the claimed invention.

26 Kloster Speedsteel AB v. Crucible, Inc., 793 F.2d 1565 (Fed. Cir. 1986); Studiengesellschaft Köhle mbH v. Dart Indus., 549 F. Supp. 716, 723 (D. Del. 1982), aff’d, 726 F.2d 724 (Fed. Cir. 1984).

Types of Prior Art 

   Prior Art  Timing § 102(a)  U.S. Knowledge or Use

Global Patents and Publications  

Public disclosure prior to invention date 

§ 102(e)  U.S. Applications thatPublish or Issue as Patents 

Filed prior to invention date 

§ 102(b)  Global Patents and Publications U.S. Public Use and Sale   

Granted or public more than one year before US filing date 

§ 102(d)  Foreign Patent grantedto Applicant 

Granted more than   one year before US filing date 

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In summary, first check that the rejection is properly made. Check that the rejection fits under the appropriate subsection as cited, and that the dates of the references relative to the priority date of the claimed invention qualify the reference as proper prior art. Next, review the cited art, paying attention to the examiner’s reasoning. Does the reference as a whole support the reasoning? Is the examiner’s assertion of anticipation correct? If not, distinguish the claims from the cited reference, providing specific citations to those portions of the reference and any outside supporting evidence that the differences are significant. If the rejection is properly made, consider amendments to the claims that can distinguish over the cited art, and also considering a potential obviousness rejection under § 103.

1. Check the Dates

Examiners operate under extreme time pressure, having on average about 16 total hours to devote to the prosecution of an application from first review to final disposal. While they are often experts in their art area, many are newly hired and lack experience. Sometimes examiners make mistakes. As a first step, check the dates of the cited references against the critical dates of the application to be sure the cited art qualifies as prior art against the claims.

Check the dates. Note if the references are being cited as § 102(b) or § 102(a) art, for example. Compare the effective dates of the references to the filing date of the pending application. Each reference should either be published more than one year prior to the application's priority date under § 102(b) or if, within one year of the application's priority date under § 102(a), may need to be checked against the invention date. If the examiner has improperly cited references are not proper prior art against the rejected claims, respond politely, explaining why the cited reference is not prior art, and ask for removal of the rejection.

Where the references are properly cited as prior art, consider various options that might be used to remove the references as qualifying art. Each is further discussed below.

(1) Claim priority to an earlier filed application

(2) Swear behind the date of the reference in a Rule 131 declaration, providing antedating evidence of prior invention;

Review the Rejections(1) Check the dates ‐ does the reference qualify as prior art? (2) Check citations ‐ is the examiner correct?(3) Read the entire reference ‐ any admissions or contradictions? (4) Is the art reliable?  Contradicted by other art?  By the application?(5) Is the claim language the problem?  Tweak to avoid?(6) Can an amendment avoid qualifying prior art?

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(3) Declare the reference as the inventor’s own work in a Rule 132 declaration, providing evidence in support;

(4) Declare the reference as derived from the inventor in a Rule 132 declaration, providing evidence in support.

a. Claiming Priority to Earlier Filed Application

Is there a priority application that the client forgot to mention? Under certain circumstance a claim of priority can be made after filing.27 The applications must be co-pending, name at least one common inventor, and disclose the common inventor’s invention. Priority can be claimed to prior-filed U.S. applications under 35 U.S.C. § 120 or foreign applications under 35 U.S.C. § 119.

Claims of priority must be made either within four months of the filing date of the rejected application or within sixteen months of the effective priority date.28 What if you cannot meet the short, non-extendable time period of four months from the filing date of the rejected application or sixteen months from the effective filing date of the priority application? Often a first office action is not received until well after these time periods have expired. Currently you are able to refile the application as an RCE or Continuation and make a claim for priority within the effective time periods. It is unclear if the impending and yet unpublished new Continuation rules will permit this opportunity for correction once the allotment of continuing applications is exceeded.

b. Swearing Behind with Rule 131 Declarations

Rule 131 provides a method to remove a reference cited as prior art under § 102(a) and § 102 (e).29 Because these rejection depends on the cited reference being published before invention by the patent applicant, a declaration stating and demonstrating completion of the invention took place before the effective date of the cited reference can remove the reference as qualifying prior art. Removing a reference in this way is sometimes called “swearing behind” the reference or “antedating” the reference. Obviously, Rule 131 declarations cannot be used to remove statutory bars under §§ 102(b) and (d).

When using a Rule 131 declaration to swear behind a reference, must make sure a date of invention before the effective date of the reference can be established. U.S. patents and applications, and PCT publications become effective as prior art references from the earlier of their publication date or the date they become effective as a reference under § 102(e).30

The filing of a Rule 131 declaration with appropriate supporting evidence can rebut the presumption of the filing date as the effective date of invention. The declaration must 27 37 C.F.R. § 1.78(a) (2006). 28 37 C.F.R. §§ 1.55, 1.78 (2006). 29 DONALD S. CHISUM, 1 CHISUM ON PATENTS § 3.08[1] (2007). 30 37 C.F.R. § 1.131(a). Generally, these patents or publications become effective as § 102(e) references when they are filed.

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demonstrate completion of the invention in the U.S.31 prior to the effective date of the cited prior art reference. This can be accomplished by showing an actual reduction to practice of the invention prior to the effective date of the reference; conception of the claimed invention prior to the effective date of the reference coupled with due diligence from prior to the reference date to a subsequent actual reduction to practice; or conception of the invention prior to the effective date of the reference coupled with due diligence from prior to the reference date to the filing date of the application (constructive reduction to practice.)32

Evidence in support of the invention can include laboratory notebook entries, test results, drawings, photographs, corroborating statements by witnesses, and the like.33 While the declaration must assert and provide evidence that the invention was made prior to the effective date of the reference, a specific date of the invention need not be disclosed. The declaration includes an assertion that the supporting documentary evidence demonstrates an invention date prior to the date of the reference, and includes notebook pages or other evidentiary showing. Dates on such evidence can be redacted in the submitted copies.

Rule 131 declarations should be approached with particular caution, as the practice carries some potential risks. Like any other papers filed with the PTO, declarations become part of an application’s prosecution history. The declarations can adversely affect the scope, validity, and enforceability of the resulting patent.

Declarations can be attractive evidence for litigating attorneys because they are made under penalty of perjury. The person signing the declaration swears to the truth of the statements made in the document, and must understand the statements to be true. Extreme caution should be used in drafting the declaration, and clarifying the statements with the person signing. Making a false declaration to the Patent Office can result in the unenforceability of the entire patent for inequitable conduct.

31 The practitioner may also show completion of the invention in a N.A.F.T.A. or W.T.O. country. 32 M.P.E.P. § 715.07. 33 M.P.E.P. § 715.07.

Caution when Making Declarations While declarations may be useful tools to overcome prior art rejections, exercise caution when making them.  Declarations are part of an application’s prosecution history and are given heightened scrutiny during litigation and claim interpretation.  

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Declarations also include specific factual assertions that can be challenged when the patentee seeks to enforce the patent. If a litigator can successfully challenge the veracity of the factual statements in a declaration, it may become the basis of an allegation that the patent was obtained through inequitable conduct, and could render the patent unenforceable.34 Even truthful statements in the declaration may constrain the patentee’s licensing or litigation strategy. It is not, therefore, always advisable to submit a declaration to remove a reference. Many practitioners regard the making of such a declaration as a last resort.35

c. Removing Co-Authored Publications and Patents with Co-Inventors with Rule 132 Declarations

Rule 132 declarations can be used to overcome prior art rejections when the inventor of the claimed invention is a co-author of the publication cited against the application.36 These situations occur when the reference is a publication of the inventor’s own work and the inventor is only one of a number of named authors on the publication. The declaration can be used, for example, to explain why the additional authors are not co-inventors. In many cases the authors include technicians or students working under the direction of the inventor, or collaborators who provided materials or discussions. A declaration by the inventor declaring that she is the sole inventor and explaining the roles of other named authors as non-inventors, for example, working under the inventor’s direction, should be sufficient to remove the publication as a reference.37

Rule 132 declarations can also be used to remove publications as prior art references under 35 U.S.C. § 103 when the reference is based on §§ 102(a) or (e).38 Obviously, Rule 132 declarations cannot be used when the cited article or patent has an effective date more than one year prior to the filing date of the claimed invention. Such articles and patents trigger the statutory bar of § 102(b) and cannot be removed.

d. Reference is Inventor’s Own Work - Rule 132 Declarations

Rule 132 declarations can also be used to disqualify a prior art reference disclosing the inventor’s own work and cited under §102(a) or (e). If it is the inventor’s own work, it cannot disclose the invention prior to the inventor having invented!

34 See, e.g., Refac Int’l, Ltd v. Lotus Dev. Corp., 1584 – 85 (Fed. Cir. 1996) (affirming the district court’s determination of inequitable conduct based on the submission of a misleading declaration). 35 See, e.g., Richard G. Berkley, Some Practical Aspects of Amendment Practice in the Electro-Mechanical Arts, 426 PLI/PAT 161, 213 – 14 (1995) (recommending that practitioners forego filing Rule 131 declarations in favor of arguing patentability without conceding that the reference is prior art). 36 M.P.E.P. § 715.01 (“When subject matter, disclosed but not claimed in a patent or application publication filed jointly by S and another, is claimed in a later application filed by S, the joint patent application publication is a valid reference under 35 U.S.C. 102 (a) or (e) unless overcome by declaration or declaration under 37 C.F.R. 1.131 or an unequivocal declaration under 37 C.F.R. 1.132 by S that he/she conceived or invented the subject matter disclosed in the patent or application publication and relied on in the rejection.”); In re DeBaun, 687 F.2d 459 (C.C.P.A 1982). 37 M.P.E.P. § 715.01(c). 38 M.P.E.P. § 706.02(k).

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When the unclaimed matter of a patent or other publication is the applicant’s own invention, a rejection under § 102(a) or (e) may be removed by submitting evidence using a Rule 132 declaration establishing that the patentee or author of the cited reference “derived” knowledge of the relevant subject matter from the inventor of the pending application.39 In these situations, the inventor must also demonstrate that they are the inventor of the subject matter being claimed.

e. Rule 132 Declarations – Miscellaneous Submissions

Rule 132 declarations can also be used to submit relevant evidence to overcome a variety of rejections. Practitioners can use such declarations to establish non-enablement of the cited reference.40 Practitioners also use Rule 132 declarations to rebut prima facie cases of obviousness by submitting evidence of non-obviousness.

2. Distinguish Cited Prior Art

After ascertaining the prior art is properly cited, any differences between the claimed invention and the cited art should be analyzed and reviewed. Remember to review the cited references completely, rather than just the section specifically pointed to by the Examiner. Review the reference with the claimed invention in mind, and consider the wording and scope of the claim in relation to the reference. What problem does the reference seek to solve? What relationship is the subject matter of the reference to the claimed invention? Is there a word choice in the claim that can help show distinctions?

a. Rejections under § 102 Generally

A rejection based on anticipation of the claimed invention under 35 U.S.C. § 102 asserts a single reference discloses each and every element of the claimed invention.41 If any element or limitation of the claim is absent from the prior art reference, there can be no anticipation.

Anticipation can be analyzed in two steps. First, construe the claim, listing every element and limitation. Understand the full scope of each term in the claim. Next, determine if each of the construed claim elements and limitations is disclosed in the prior art reference. Consider the entire reference.

If the reference fails to disclose all the elements of the rejected claim, the reference does not anticipate the claimed invention and the rejection is improper. The rejection can be respectfully traversed, indicating the discrepancies to the examiner in a response to the Office 39 37 C.F.R. § 1.132; M.P.E.P. § 715.01(c). 40 See Elan Pharms., Inc. v Mayo Found., 346 F.3d 1051, 1054 (Fed. Cir. 2003) (“Enablement requires that ‘the prior art reference must teach one of ordinary skill in the art to make or carry out the claimed invention without undue experimentation.’” (quoting Minn. Mining and Mfg Co v. Chemque, Inc., 303 F.3d 1294, 1301 (Fed. Cir. 2002))); In re Donahue, 766 F.2d 531, 533 (Fed. Cir. 1985) (explaining the requirement that prior art references must be enabling). 41 See M.P.E.P. 2131; In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997); Glaxo Inc. v. Novopharm Ltd., 52 F.3d 1043, 1047 (Fed. Cir. 1995); Scripps Clinic & Res. Found. v. Genentech, Inc., 927 F.2d 1565, 1576 (Fed. Cir. 1991); Verdegaal Bros. v. Union Oil Co. of Cal., 814 F.2d 628, 631 (Fed. Cir. 1987).

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Action. Avoid arguments directed toward unclaimed features, or other discussion that is unpersuasive and irrelevant. Describe the missing element(s) and why the Examiner’s citation is faulty.

Although anticipation requires a showing of each claim element in a single reference, the examiner may use additional references in the rejection. Extra references and extrinsic evidence might show that the primary reference is enabled.42 Such references may also be used to explain the meaning of terms in the primary reference.43 Finally, such references may be used to show an inherent characteristic of the prior art reference.44 In these situations, both the rejection and the extra references should be carefully reviewed to ensure that the secondary reference is not being used to expand the primary reference beyond what it discloses. Examiners may only use secondary references in an anticipation rejection under § 102 to interpret a term, explain a term, or demonstrate an inherent characteristic present in the primary reference.

b. Inherency Rejections Under § 102

Examiners may reject a claimed invention under § 102, citing a reference that does not disclose all the features of the claimed invention, but alleged by the examiner to inherently disclose the claimed invention.45 In an inherency rejection, the examiner must provide objective evidence or reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art.46 Any rejection involving an inherent disclosure that lacks such reasoning does not establish anticipation.

The Federal Circuit has failed to arrive at a consistent standard for determining inherency. As a result, practitioners struggle with responses to inherency rejections. For example, inherency analysis differs depending on whether one is analyzing product or method claims. Product claims that recite exactly a structure present in the prior art are anticipated regardless of whether the claims also recite some new function or characteristic of the structure.47 Method claims reciting new uses and procedural steps are not inherently disclosed if their purpose is not prior known. For example, using aspirin to treat headaches does not inherently anticipate the use of aspirin to treat heart disease.

Inherency rejections may be proper even when the inherent properties were not appreciated by the inventor or author of the cited prior art reference. For example, the Federal Circuit held in SmithKline Beecham Corp. v. Apotex Corp.48 that claims to a hemihydrous 42 See M.P.E.P. § 2131.01; In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985); In re Samour, 571 F.2d 559 (C.C.P.A. 1978). 43 See M.P.E.P. § 2131.01; In re Baxter Travenol Labs, 952 F.2d 388 (Fed. Cir. 1991). 44 See M.P.E.P. § 2131.01; Continental Can Co. USA v. Monsanto Co., 948 F.2d 1264, 1268 (Fed. Cir. 1991). 45 Inherent disclosures of a prior art reference may be relied upon for anticipation rejections under 35 U.S.C. § 102 and obviousness rejections under 35 U.S.C. § 103. See also In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). 46 M.P.E.P. § 2112; Ex parte Levy, 17 U.S.P.Q.2d 1461, 1464 (B.P.A.I. 1990). 47 In re Spada, 911 F.2d 705, 709 (Fed. Cir. 1990). 48 403 F.3d 1331 (Fed. Cir. 2005).

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compound were inherently disclosed in a cited process for producing an anhydrous pharmaceutical compound, where the process resulted in trace, undetectable amounts of a hemihydrous version of the same compound anticipated the.49 The Federal Circuit found inherent anticipation of the compound claim, even though the technicians producing the anhydrous compound would not have known they were producing the hemihydrous compound.50 The Federal Circuit has also held, however, that where a patent claims a novel method of using a known product, that method is unanticipated, even when the benefit of the novel method may have been achieved accidentally by using the teachings of the prior art.51

When presented with a rejection based on inherent disclosure, the rejection should be analyzed to ensure the examiner has provided a sufficient rationale supporting any inherent characteristic. “The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”52 Inherency may not be the result of “optimization of conditions,”53 nor may inherency “be established by probabilities or possibilities.”54

Remember that inherency requires the claimed invention must necessarily flow from the disclosure in the cited prior art. The reference itself may provide evidence of other possible outcomes. Consider other evidence that might be available in the literature or in the inventor’s work that can cause doubt on the certainty of the outcome.

Where the claim is a method or product, remind the examiner that the preamble of a method claim describes the outcome of the claim. While the method steps may be similar (e.g., administering aspirin to a patient), the outcome of the steps may provide a result that is not prior known, and not inherently anticipated.

c. Genus and Species Anticipation

Plentiful case law has clearly established the fact that a species will anticipate a claim to a genus.55 For example, prior art disclosing a welding compound with the key element of magnesium silicate anticipates a claim in an application to the identical compound where the key element is “silicate.”56

49 Id. at 1346. 50 Id. at 1342 – 46. See also Abbott Labs. v. Baxter Pharm. Prod., Inc., 471 F.3d 1363 (Fed. Cir. 2006) (holding that the addition of water to stabilize and inhaled anesthetic after shipping was anticipated by the prior art disclosing the presence of water with the anesthetic during production). 51 Perricone, 432 F.3d 1368. 52 M.P.E.P. § 2112; In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999). 53 In re Oelrich, 666 F.2d 578, 581-82 (Fed. Cir. 1993). 54 Id. at 581. 55 See M.P.E.P. § 2131.02; In re Gosteli, 872 F.2d 1008 (Fed. Cir. 1989); In re Slayter, 276 F.2d 408, 411 (C.C.P.A. 1960). 56 DONALD S. CHISUM, 1 CHISUM ON PATENTS § 3.02[2][a] (2007) (citing Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605 (1950)).

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Similarly, “a generic chemical formula will anticipate a claimed species covered by the formula when the species can be ‘at least once envisaged’ from the formula.”57 A prior art genus does not, however, necessarily anticipated a later-claimed species.58 Generally, a genus will only anticipate a claimed species if the species is clearly named.59

d. Anticipation of Ranges

Anticipation rejections using prior art references with ranges overlapping a range in the claimed invention are analogous to genus-species rejections. A specific example in the prior art within a claimed range anticipates that range.60 For example, if a reference discloses that Compound A comprises elements B, C, and D and includes an example where D is present in the amount of 9 percent by weight, that references anticipates a pending claim that claims a compound comprising B, C, and D where D is present in the amount of 5 to 15 percent by weight.

The converse is not necessarily true. A broad range does not necessarily anticipate narrow ranges that fall within the broad range. Prior art which teaches a range within, overlapping, or touching the claimed range only anticipates the claimed range if the prior art range discloses the claimed range with “sufficient specificity.”61 Determinations of sufficient specificity are fact dependent. If the claims are directed to a narrow range, and the cited reference discloses a broad range, it may be reasonable to conclude that the narrow range is not disclosed with sufficient specificity.62

57 M.P.E.P. § 2131.01. 58 Id. 59 Id. But see Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1380 (Fed. Cir. 2001) (holding that “the disclosure of a small genus may anticipate the species of that genus even if the species are not themselves recited.”) 60 See M.P.E.P. § 2131.03; Titanium Metals Corp. v. Banner, 778 F.2d 775 (Fed. Cir. 1985). 61 See M.P.E.P. 2131.03. 62 Id. See also Atofina v. Great Lakes Chem. Corp., 441 F.3d 991, 999 (Fed. Cir. 2006) (holding that a reference’s temperature arrange of 100 – 500 degrees C did not describe with sufficient specificity the claimed range of 330 – 450 degrees C to be anticipatory).

Genus – Species AnticipationA broadly stated genus does not anticipate a claimed single species.  A single species anticipates a broadly stated genus. 

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e. Non-Enabled Prior Art References

Prior art references, in addition to anticipating every element of the claimed invention, must be enabled, e.g., must teach how to make and use, with an expectation of success. A disclosure is non-enabling if it fails to place the subject matter of the claims in the possession of the public.63

The prior art may suggest the claimed invention but fail to make or use it. Contradictory evidence may be available to show the prior art was inoperable or not expected to function. Evidence of non-enablement can be submitted using Rule 132 declarations. Such declarations must identify the specific deficiencies of the reference and explain why those deficiencies fail to provide a person of ordinary skill in the art with the subject matter allegedly disclosed.64 Broad statements alleging non-enablement likely fail to address the examiner’s enablement rationale and will not disable a prior art reference.

Anyone competent to testify about the level of ordinary skill in the art and what the reference would reveal to such a person may submit a Rule 132 declaration for purposes of showing non-enablement or enablement. This includes, for example, an inventor of the claims at issue.65 The credibility of such a declaration will be weighed by the fact-finder. Recent Board of Appeals and Federal Circuit cases make clear that real evidence and sound reasoning supporting any conclusions or opinion of the declarant is required for a credible showing.

3. Amending Claims to Distinguish Over the Prior Art

Often the specific wording or breadth of the claims draws in prior art that can be readily distinguished by changing the claim wording, often without impacting client needs or expectations. For example, a dependent claim to a surgical tool describing an edge as “serrated” may bring in all types of art that might be distinguished by more particularly describing the patterned edge of the tool. Look for word changes that can moot the rejection while achieving client objectives.

63 Elan Pharms., 346 F.3d at 1054; In re Wilder, 429 F.2d 447, 451 (C.C.P.A 1970). 64 See, e.g., In re Lamberti, 545 F.2d 747 (C.C.P.A. 1976) (citing In re Lindner, 457 F.2d 506 (C.C.P.A. 1972) (rejecting declaration alleging inoperability of reference as lacking factual evidence)). 65 See In re Deminski, 796 F.2d 436, 442 (Fed. Cir. 1984).

Numerical Range AnticipationGenerally, a broad range does not anticipate a narrow range or specific value.  However, specific values within a range and a narrow range can both anticipate a broader range. 

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Anticipation rejections can often be overcome by narrowing the scope of the claims to avoid the cited art, for example, adding a claim limitation that is not disclosed by the prior art. In amending a claim to avoid a § 102 rejection, consider the impact the amendment might have under § 103 as well. Will the amendment trigger a subsequent obviousness rejection based on the same reference or satisfy obviousness as well as anticipation?

Before submitting a response to the anticipation rejection, add a discussion to proactively assert that any obviousness rejection is also addressed by the amendment. In the response to the Examiner’s Office Action, each rejection must be addressed, explaining the amendments as they relate to the rejection and pointing out how the amendment overcomes the specific disclosure of the reference, e.g., a specific element added to the claim is not found in the cited reference.

Amendments to the claims cannot add new matter to the application.66 Any proposed amendment must be supported by the disclosure found in the application, claims, and drawings as originally filed. This support should be pointed out in the response.

Be cautious when amending claims to overcome prior art rejections. Amendments may greatly impact subsequent litigation due to the doctrine of prosecution history estoppel.67

66 35 U.S.C. § 132(a) (2007).

Checklist: Responding to § 102 Rejections 

o Understand the Rejection o Read rejection thoroughly 

o Disqualify Prior Art o Claim Priority o Swear Behind o Remove Co‐Authored Publications 

o Prove Prior Art Is Inventor’s Own Work o Add Author of Prior Art as Co‐Inventor 

o Argue o Improper Rejection, Reasoning o Prior Art Not Enabled o Factual Evidence Supporting Arguments 

o Amend Claims o Word choices o Narrow scope 

 

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C. REJECTIONS UNDER 35 U.S.C. § 103 – OBVIOUSNESS

1. 35 U.S.C. § 103

A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between 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.68

2. Prior Art Under 35 U.S.C. § 103

Obviousness rejections are based upon 35 U.S.C. § 103. Unlike rejections based on §102, each cited reference need not teach each and every element of the claim. Rather, an obviousness rejection is based on a reference that only partially teaches the claimed invention, along with an assertion that it would be “obvious” to modify the cited reference to obtain the claimed invention, in light of the teachings of other references or what is known to one of ordinary skill in the art.

To be cited as prior art under § 103, a reference must satisfy the conditions set out in § 102. There are two specific exceptions, however; § 103 (c)(1) and (2). These exceptions, the first for corporations and the second for Universities and research entities, were designed to protect the common work of entities that are home to multiple inventors.

According to § 103 (c)(1), subject matter developed by another that qualifies as prior art only under § 102 (e), (f), or (g), is not prior art under § 103, if the subject matter and the claimed invention were owned by the same person or subject to an obligation of assignment to the same person at the time the invention was made.

The CREATE Act is codified in § 103 (c)(2), and provides that subject matter created by another shall be treated as owned by the same person or subject to an obligation of assignment to the same person if three criteria are met: the claimed invention was made by or on behalf of parties to a joint research agreement that was in effect on or before the date of invention; the claimed invention resulted from activities within the joint research agreement; and the application containing the claimed invention discloses or is amended to disclose the names of the parties to the joint research agreement.

3. Responding to Obviousness Rejections Under 35 U.S.C. § 103

Typically, an Examiner relies on a primary reference as teaching most elements of the claimed invention. The Examiner will explain the teachings of the primary reference and its deficiencies. Secondary references will be cited to fill in the gaps, together with evidence and/or

67 535 U.S. 722 (2002). In Festo the Supreme Court held that amendments made with regard to patentability may give rise to prosecution history estoppel. After Festo, narrowing amendments may estop patent holders from asserting a claim of infringement under the doctrine of equivalents. 68 35 U.S.C. § 103(a) (2007).

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reasoning why one skilled in the art would have made the combination at the time of the invention, with an expectation of success.

4. Obviousness post-KSR

In KSR, the Supreme Court overturned the Federal Circuit’s rigid application of the Teaching-Suggestion-Motivation test (“TSM test”) for determining the propriety of combining references. The Court also provided dictum contrary to traditional obviousness analysis, including suggestions that the knowledge of one skilled in the art includes “normal creativity”, and that “obvious to try” might evidence obviousness.

The Court emphasized the need for caution when granting a patent on an invention based upon the combination of elements found in the prior art.69 The combination of familiar elements according to known methods, the Court reasoned, is likely obvious if it yields predictable results.70 For such an invention to be patentable, it must exhibit more than the predictable result of the combination.71

Noting that an obviousness rejection must include “some reason” to combine references, and that the reason may come from different art areas, the Court stated it is often necessary to look to “interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art” to determine whether there is a reason to combine the known elements as claimed.72 The Court also stated that an examiner making an obviousness rejection must make the analysis explicit in the record.73

Precise teachings of the specific subject matter of the rejected claim are not required, since the creative ability and understanding of one of skill in the art can be applied. In addition, an examiner can use the same inferences and creative steps as a person of ordinary skill in the art.74

The Supreme Court re-affirmed that Graham v. John Deer75 provides a framework for obviousness analysis. While dictum in KSR seems to turn many of Graham’s objective indicia of non-obviousness into indicia of obviousness, the Court affirmed Graham’s three-pronged approach to obviousness:

(1) Determine the scope and content of the prior art;

(2) Determine the differences between the prior art and the claims at issue; and

69 KSR Int’l. Co. v. Teleflex, Inc., 550 U.S. 398 (2007) 70 Id. 71 Id. at 1740. 72 Id. at 1740 – 41. 73 Id. at 1741. 74 Id. 75 Id. at 1734 (citing Graham v. John Deere Co. of Kansas City, 383 U.S. 1 (1966)).

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(3) Determine the level of ordinary skill in the pertinent art.

Graham also requires that objective indicia of non-obviousness, including “commercial success, long felt but unsolved needs, [and] failure of others” be considered.76 In practice, objective evidence of unpredictability is given considerable weight. One important consideration is "teaching away", meaning evidence that points one of skill in the art in a different direction from the claimed invention. In recent cases, however, evidence showing an unsuccessful trial may not be sufficient; a showing that the trial could not have possibly worked is more likely to succeed.

The Supreme Court’s test for obviousness is controlled by the objective reach of the claim.77 If the claim extends to what is obvious, it is invalid. Specifically, the KSR Court stated that a claim is obvious if there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patent’s claims.78 When considering the potential obviousness of a combination, the question is whether the combination was obvious to a person of ordinary skill in the art, not to the inventor. The Court stated the person of ordinary skill in the art is a person of ordinary creativity in addition to ordinary skill, who is capable of combining prior art references to arrive at novel solutions to problems without the specific teaching that each reference might be used to solve such a problem.79

The Court also overturned a well established body of law holding that rejections stating it would be “obvious to try” certain combinations are improper.80 “Obvious to try” rejections now appear to be sanctioned by the KSR Court.81

The Federal Circuit’s obviousness jurisprudence immediately prior to the Supreme Court’s decision in KSR,82 as well as its post-KSR jurisprudence,83 demonstrates a more flexible approach to obviousness than the Federal Circuit previously employed. Practitioners should note, however, that the PTO continues to require that examiners show some reason to combine cited references for obviousness determinations.84

76 Id. 77 Id. at 1741 – 42. 78 Id. at 1742. 79 Id. 80 Id. The Federal Circuit had previous held that obvious to try did not constitute obviousness. In re Deuel 51 F.3d 1552, 1559 (Fed. Cir. 1995). 81 See, e.g., Ex parte Kubin, Appeal 2007-0819, at *8 (B.P.A.I. May 31, 2007) (affirming Examiner’s rejection finding that protein sequence and cDNA molecule coding for sequence were obvious to try). 82 These cases, such as DyStar Textilfarben GmbH & Co. Deutschland KG v. C. H. Patrick Co., 464 F.3d 1356 (Fed. Cir. 2006), and Alza Corp. v. Mylan Labs., Inc., 464 F.3d 1291 (Fed. Cir. 2006), have come to be known as “The Federal Circuit’s Amicus,” and have been thought of as the Federal Circuit’s attempt to avoid being overruled. 83 See, e.g., Leapfrog Enterprises, Inc. v. Fisher-Price, Inc., 485 F.3d 1157 (Fed. Cir. 2007). 84 Memorandum from Margaret A. Focarino, Deputy Comm’r for Patent Operations, Patent & Trademark Office on the Supreme Court decision on KSR (May 3, 2007) (on file with author).

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Cases from the USPTO Board of Appeals and Interferences (“BPAI”) published shortly after the KSR opinion demonstrate the USPTO’s response to the KSR decision. These cases, including Ex parte Kubin,85 Ex parte Smith,86 and Ex parte Catan,87 articulate the BPAI’s new standard when undertaking an obviousness analysis. In each of the cases, the Board sought to determine:

(1) whether each of the claimed elements is found within the scope and content of the prior art;

(2) whether one of ordinary skill in the art could have combined the elements as claimed by methods known at the time of invention was made; and

(3) whether one of ordinary skill in the art would have recognized at the time the invention was made that the capabilities or functions of the combination were predictable; 88

(4) whether claimed combinations are uniquely challenging or difficult for one of ordinary skill in the art;89 and

(5) and whether the invention would require more than ordinary creativity.90

5. Prior Art Available for Obviousness Rejections

Generally speaking, any event, act, or reference that is as prior art under 35 U.S.C. § 102 is also prior art under § 103.91 Unlike § 102, which requires that every element of a rejected claim be present in a single prior art reference, § 103 allows examiners to combine references when making rejections, or to combine one or more references with the knowledge of a person of ordinary skill in the art.92

The Examiner may draw on the knowledge of the hypothetical person of skill in the art when that particular knowledge may not be explicit in a prior art reference.

85 No. 2007-0819 (B.P.A.I. May 31, 2007). 86 No. 2007-1925 (B.P.A.I. June 25, 2007). 87 No. 2007-0820 (B.P.A.I. July 3, 2007). 88 Smith, No. 2007-1925, at *18. 89 Id. 90 Id. at *20. 91 See, e.g., Hazeltine Research, Inc. v. Brenner, 382 U.S. 252, 255 (1965) (holding that § 102(e) art is available for obviousness determinations); In re Foster, 343 F.2d 980, 988 (C.C.P.A. 1965) (using § 102(b) art in obviousness determination); MERGES & DUFFY, supra, at 764 (“There has never been any doubt that § 103 prior art includes references under § 102(a), all of which are publicly available.”) (parenthetical information omitted). 92 UNITED STATES PATENT AND TRADEMARK OFFICE, MANUAL OF PATENT EXAMINING PROCEDURE §§ 706.02(j), 2141 – 2144.09 (2006) [hereinafter M.P.E.P.].

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In practice, the Board of Appeals and Federal Circuit require that the obviousness rejection be evidenced in the record, including evidence showing the presence of each claim element in one or more reference, evidence of the skill of one in the art, and evidence/reasoning that one of skill in the art would have made the claimed combination. The evidence provided is weighed against the potential of hindsight bias.

6. The post-KSR Prima Facie Case

A prima facie case of obviousness must satisfy three basic criteria.93 The cited references must be proper prior art (check dates). The combination of references must disclose every element of the rejected claim. The Examiner must articulate some reason why one skilled in the art would modify a reference or would combine the teachings of multiple references. In addition, the claimed combination must provide a reasonable expectation of success in achieving the claimed invention. Finally, the reference(s) must teach or suggest all the claim limitations.

As discussed above, the Supreme Court’s recent decision in KSR International Co. v. Teleflex Inc.,94 has altered the analysis of obviousness. The full impact of KSR is yet to be understood; however, recent USPTO Examiner Guidelines for determining Obviousness in view of KSR as well as post-KSR Board of Appeals and Federal Circuit decisions provide some insight into how the PTO will examine cases. In these decisions, obviousness was found more often than non-obviousness. The most likely reasons for finding non-obviousness included: that a claim element is missing from the cited combination; that evidence of record is insufficient to support the rejection; or that strong evidence of teaching away, unpredictability, or difficulty in reaching the invention was either not considered or not given sufficient weight in the analysis.95

7. Responding to Obviousness Rejections

93 M.P.E.P. § 2142 (citing In re Vaeck, 947 F.2d 488 (Fed. Cir. 1991). 94 127 S. Ct. 1727 (2007). 95 See, Ranck and Kettelberger, 2008, AIPLA Web Seminar August 6, 2008 “A Practical Approach To KSR”.

Checklist: Responding to § 103 Rejectionso Understand the Rejection

o Read rejection thoroughly o Read the art thoroughly 

o Disqualify Prior Art o Same Methods as § 102 

o Provide Evidence of Non‐Obviousness o Evidence supporting argument o Teaching away – could not have worked o References Are Non‐Combinable o Totality of Facts Show Non‐Obviousness 

o Amend Claims 

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a. Examiner Guidelines for Determining Obviousness Post-KSR96

The USPTO Examination Guidelines provide the following list of reasons why an Examiner may find claims to be obvious. These are derived from the Supreme Court’s KSR opinion, and are provided in outline form, together with exemplary fact patterns taken from supporting case law.

A Combination of known elements for predictable results

B Simple substitution of one known element for predictable results

C Applying known technique to improve similar device or method in same way

D Applying known technique to known device or method ready for improvement

E Obvious to try

F Variation prompted by market pressures and design choices

G Teaching/Suggestion/ Motivation

A review of why claims were found obvious in 16 post-KSR Federal Circuit cases produced the following results:

Obviousness Reason A B C D E F G Total

Chem/Bio - 1 - 1 4 - - 6

Electrical/Computer 1 1 - - - - - 2

Mechanical 1 1 - - 4 1 - 7

Business Methods - - - - 1 - - 1

Total 2 3 0 1 9 1 0 16

Notably, lack of TSM (G) was not a reason for finding non-obviousness in any of these cases, whereas “Obvious to try” (E) appeared most often. As more cases are decided, tests for obviousness will be honed and further defined. Until then, one can look to Board of Appeals and Federal Circuit opinions for guidance, and the development of trends that may apply to a specific case.

96 Examination Guidelines for Determining Obviousness Under 35 U.S.C. 103 in View of KSR (Federal Register 72:57526 October 10, 2007)

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b. Removing Prior Art References Prior art references cited as the basis for § 103 obviousness rejections may be overcome

using the same strategies discussed above regarding § 102 rejections.

c. Overcoming Obviousness Rejections by Argument

i. Non-Analogous Art

Before KSR, case law considered a reference analogous to that of the invention if it was either “within the field of the inventor’s endeavor,” or “reasonably pertinent to the particular problem with which the inventor involved.”97 Post-KSR, the reach of analogous art extends to those fields where a POSA might look to find solutions obtained by others when solving similar problems. See, for example, In re. Icon Health, where a POSA seeking to solve the problem of gently closing a foldable treadmill would have reasonably looked to how others had solved the problem of closing a foldable bed.98

Post-KSR, a non-analogous art argument is unlikely to succeed, unless a clear teaching away or inability to understand the reference is demonstrated. Because obviousness determinations no longer require the cited references to provide an explicit motivation to combine references, examiners and courts will likely give the “analogous arts” a broader reach.

ii. POSA Would Not Make the Combination Suggested by the Examiner

When an examiner rejects a claim under 35 U.S.C. § 103, she must adhere to the following tenets of patent law:

(1) the claimed invention must be considered as a whole;

(2) the references must be considered as a whole;

(3) there must be some reason articulated why one of ordinary skill in the art would combine the references to make the claimed combination;

(4) the references must be viewed without the benefit of impermissible hindsight vision afforded by the claimed invention; and

(5) reasonable expectation of success is the standard by which obviousness is determined.

97 M.P.E.P. § 2141.01(a); In re Oetiker, 977 F.2d 1443, 1446 (Fed. Cir. 1992). See also Deminski, 796 F.2d at 442. 98 In re Icon Health 496 F.3d 1374 (Fed. Cir. 2007)

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For example, it is improper to combine references where one reference teaches away from the combination.99 References that teach away from the claimed invention negate any alleged reason to combine, as one of ordinary skill in the art would neither make the combination nor expect success. Any disclosure that “teaches away” from the claimed invention should be discussed in the response to the Office Action.

The entire reference must be considered, not just the portion relied upon by the examiner. Examiners may not pick and choose elements from several references to “build” an obviousness rejection. Such hind-sight reconstruction is improper.100 Arguments that the examiner used an improper pick and choose method to obtain the invention become stronger as the number of references applied increases. Further, it is impermissible to use an applicant’s invention as a “roadmap” to piece together the teachings of the prior art in order to render the claims obvious.

Post-KSR, Examiners commonly assert a prima facie case of obviousness using the rationales described in the USPTO Examiner’s Guidelines for Determining Obviousness. The burden then shifts to the patent applicant or owner to discredit the prima facie case and/or rebut obviousness with specific and meaningful evidence of non-obviousness, for example of unpredictability of the invention.

The examiner’s explicit reason for combining cited references should be evaluated. Consider if the reasoning and logic is valid, or if there are any gaps suggesting a lack of motivation to combine.

iii. References Not Combinable Because Resulting Combination Is Not the Claimed Invention

Every element and limitation of the rejected claims must be found in the combined references.101 If the claims include elements not found in the combination, respond to the rejection by highlighting specific claim language that distinguishes over the combination.

The cited combination may also require a substantial element that is lacking in the claimed invention but is necessary for the combination to function. A response emphasizing that the claimed invention lacks the substantial element, yet is still functional, may overcome the rejection. The cited combination, however, must not teach or suggest the suitability of the claimed combination.

iv. Establishing Totality of the Facts Show Invention Is Not Obvious

An examiner must also consider any applicable “secondary considerations”.102 Such evidence includes unexpected results, commercial success, long-felt need, failure of others, 99 KSR, 127 S. Ct. at 1740. See also M.P.E.P. § 2145; In re Grasselli, 713 F.2d 731, 743 (Fed. Cir. 1983). 100 M.P.E.P. § 2145; but see In re McLaoughlin, 443 F.2d 1392, 1395 (C.C.P.A. 1971). 101 EMI Group North Am., Inc. v. Cypress Semiconductor Corp., 104 F. Supp. 2d 370, 386 (D. Del. 2000), aff’d in part, rev’d in part, 268 F.3d 1342 (Fed. Cir. 2001) (“There is a strong presumption against finding claims invalid for obviousness when the prior art does not disclose every element of the claimed invention.”).

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copying by others, licensing, and skepticism of experts.103 Bringing evidence of secondary considerations to the attention of the examiner, whether contained in the application, cited references, or other publications, may overcome the rejection. In addition, comparative data, statements of experts (for example the authors of the cited art), or other distinguishing evidence can be submitted in the form of Rule 132 declarations to support arguments of non-obviousness.

Secondary evidence must be relevant to the claimed subject matter to be of probative value.104 The presence of unexpected results or absence of expected results is an indication of non-obviousness and is often the best way to overcome obviousness rejections.105 Evidence that a property of the claimed invention is superior to a similar property present in the prior art also indicates non-obviousness.106

Carefully review the specification and the cited art, as well as the relevant art in the field for evidence of unexpected results. Arguments supported by specific evidence of secondary considerations must be considered, but conclusory statements or pure argument are unlikely to be successful. Comparative data in the application or relevant data generated after the application was filed can be relied on to distinguish art. Any evidence not already in the prosecution record should be submitted to the examiner, together with an explanation of its relevance.

102 127 S. Ct. at 1734. See also Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 – 39 (Fed. Cir. 1983); W.L. Gore & Assoc., Inc. v. Garlock, Inc., 721 F.2d 1540, 1555 (Fed. Cir. 1983). 103 See, e.g., KSR, 127 S. Ct. at 1734; Stratoflex, 713 F.2d at 1538 – 39; W.L. Gore, 721 F.2d at 1555. See also M.P.E.P. §§ 716 – 716.06. 104 M.P.E.P. § 716.01(b). See also Ashland Oil, Inc. v. Delta Resins & Refactories, Inc., 776 F.2d 281, 305 n. 42 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986). 105 M.P.E.P. § 716.02(a). See also In re Corkill, 771 F.2d 1496 (Fed. Cir. 1985). 106 M.P.E.P. § 716.02(a). See also In re Chupp, 816 F.2d 643, 646 (Fed. Cir. 1987).

Secondary ConsiderationsThe following may be objective evidence showing non‐obviousness:  

• Unexpected Results • Long‐felt need • Copying by others • Skepticism of experts • Commercial Success • Failure of others • Licensing • Other evidence 

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d. Amending Claims

A claim amendment may overcome § 103 obviousness rejections in addition to § 102 rejections. The same potential issues apply, including prosecution history estoppel concerns.

D. CONCLUSION

Responding to prior art rejections under 35 U.S.C. § 102 and § 103 requires checking dates of references to determine if the art is properly cited; considering if the art discloses all the elements of the claimed invention; determining if the art can be disqualified; considering claim amendments to distinguish the art; and supporting the response with specific evidence. Responding to obviousness rejections will remain challenging while we await further honing of the KSR decision.

IV. Practice Tips

A. DRAFTING TIPS

• Draft applications and claims using simple, clear terms

• Specifically define key terms in the specification, particularly if a common meaning of a term includes an undesirable or unusable embodiment

• Don’t define terms too broadly; define what can be supported

• Link methods to specific machines and data to tangible objects

• Review draft claims for clarity and streamline wording

• Check and recheck how claim terms are used in the specification

• Be consistent in word choices and usage

• Build positive limitations into the specification, including machine requirements for machines used in processes

• Avoid multiple definitions and redundant terms

• Build the logic of claim scope into the specification

• Use prior art and knowledge in the art to trace the logical claim scope

• Provide multiple tiers of evidence for utility, written description, enablement, and claim scope

• Provide experimental details of working a prophetic examples, with expected alternatives in the prophetic examples (setting up for declaration providing later evidence, if needed)

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B. PROSECUTION TIPS

• Know the prosecution history of the application and its portfolio cases

• Provide a consistent prosecution

• Understand what arguments and amendments are of record

• Know the prior and later art; look for themes consistent with your invention and distinctions that can be made

• Look to your own art and that of others

• Track and verify the language of the specification in your responses

• Avoid unnecessary comments and amendments

• Know the impact of any admission made on the patent portfolio

• Don’t accept the Examiner’s statements as true; verify assumptions and factual assertions

• Compare the requirements of the rejection’s prima facie case against the examiner’s rejection

• Argue, don’t admit the prima facie case

• Search the art for what is “known to one skilled in the art”

C. AFFIDAVIT/DECLARATION TIPS

• Use sparingly.

• Confirm truth of facts stated.

• Be certain Declarant understands the seriousness of the document and the ramifications if statements are false or misleading.

fb.us.4334560.01

1 In re Bilski, 545 F.3d 943, 88 U.S.P.Q.2d 1385 (Fed. Cir. 2008),. 2 In re Nuijten, 515 F.3d 1361 (Fed. Cir. 2008) 3 4 LabCorp v. Metabolite, 548 U.S. 124, 126 S. Ct. 2921, 79 U.S.P.Q.2D (BNA) 1065, (2006)(refused for cert, U.S. Sup.Ct. cite dissent). 5 Bremmer v. Manson 383 U.S. 519, 536 (1966). 6 Fregeau v. Mossinghoff, 776 F.2d 1034 (Fed. Cir. 1985).

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7 In re. Newman, 782 F.2d 971 (Fed. Cir. 1986). 8 In re. Schwartz, 232 F.3d 862 (Fed Cir. 2000). 9 Raytheon C. v. Roper Corp., 724 F.2d 951 (Fed. Cir. 1983), cert den’d, 469 U.S. 835. 10 In re. Cortright, 165 F.3d 1353 (Fed. Cir. 1999). 11 Vas-Cath, Inc. v. Mahurkar, 935F.2d 1555, 1560 (Fed. Cir. 1991). 12 MPEP §2163.04. 13 In re Lundak, 773 F.2d 1216 (Fed. Cir. 1985). 14 Enzo, supra. 15 Vas Cath, Supra at 1563. 16 University of Rochester v. G.D. Searle & Co., Inc., 2004 WL 1489101 (Fed. Cir. Jul. 2, 2004). 17 Enzo Biochem, Inc. v. Gen-Probe, Inc., 296 F.3d 1316, 1330 (Fed. Cir. 2002). 18 Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). 19 Regents of the Univ. Calif. v. Eli Lilly & Co., 119 F.3d 1559, 1565 (Fed. Cir. 1997), citing Lockwood, supra. 20 Judge Newman, Dissenting: Univ. Rochester v. Searle, refusal to hear en banc (Fed. Cir. 2004) . 21 Regents of the Univ. Calif. v. Eli Lilly & Co., 119 F.3d 1559, 1565 (Fed. Cir. 1997), quoting Fiers v. Revel, 984 F.2d 1164, 1171 (Fed. Cir. 1993). 22 Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563 (Fed. Cir. 1991). 23 Judge Lourie, Concurring: Univ. Rochester v. Searle, refusal to hear en banc (Fed. Cir. 2004). 24 Judge Rader, Dissenting: Univ. Rochester v. Searle, refusal to hear en banc (Fed. Cir. 2004). 25 In re Wands, 858 F.2d 731,737 (Fed. Cir. 1988). 26 CFMT, Inc. v. Yieldup Int'l Corp., 349 F.3d 1333, 1338 (Fed. Cir. 2003). 27 In re Marzocchi, 439 F.2d 220, 224 (CCPA 1971). 28 Regents of Univ. Ca. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. den’d, 510 U.S. 1440. 29 Id. 30 Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., Ltd., 535 U.S. 722 (2002). 31 Hybritech Inc. v. Monoclonal Antibodies, Inc. 803 F.2d 1367 (Fed. Cir. 1986), cert den’d, 480 U.S. 947 (1987). 32 Engel Ind., Inc. v. Lockformer Co., 946 F.2d 1528 (Fed. Cir. 1991). 33 Harris Corp. v. IXYS Corp., 114 F.3d 1149 (Fed. Cir. 1997). 34 Amgen, Inc. v. Chugai Pharm. Co., LTD., 927 F.2d 1200 (Fed. Cir. 1991) cert. den’d, 502 U.S. 856 (1989). 35 Brooktree Corp. v. Advanced Micro Devices, Inc. 977 F.2d 1555 (Fed. Cir. 1992). 36 In re Hayes Microcomputer Products, Inc. Patent Litigation (Ven Tel., Inc v. Hayes Microcomputer Products, Inc.), 982 F.2d 1527 (Fed. Cir. 1992). 37 Slimfold Mfg. Co., Inc. v. Kinkead Ind., Inc., 810 F.2d 1113 (Fed. Cir. 1987). 38 In. re. Morris, 127 F.3d 1048 (Fed. Cir. 1997), revised on reh’g, 127 F.3d 1048 (Fed. Cir. 1997). 39 S3 Inc. v. nVIDA Corp., 259 F.3d 1364 (Fed. Cir. 2001).