AIPLA Practical Prosecution Training for New Lawyers August 27, 2009 Responding to Rejections Denise M. Kettelberger, Ph.D., J.D. Faegre & Benson, LLP Minneapolis, MN 55402 612-766-7181 dkettelberger@faegre.com
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: 2
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 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. The language any new and useful process, machine, manufacture or composition of matter, or any new or useful improvement has been construed by the Court to include anything under the sun that is made by man. 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; 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. Currently the U.S. Supreme Court is reviewing the requirements of 35 U.S.C. 101 patentable subject matter in the 2008 Federal Circuit case In re Bilski. 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. 3
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 (Diamond v. Chakrabarty) 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 is often quoted as the standard. 1 However, this open standard has been recently challenged on multiple fronts, including business method, 1 electrical signal, 2 software, 3 and medical diagnostic 4 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 is currently considering the Federal Circuit s holding in one such process case (In re Bilski). In the meantime, non-process claims continue to be examined under former case law and standards; process claims are examined under the new Bilski test; and all of us await judicial clarification of the scope of patent eligible subject matter. 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 of these, however, are accepted as patentable subject matter. Under State Street Bank v. Signature Financial Group, 149 F.3d 1368 (Fed. Cir. 1998), subject matter that includes an algorithm, another exception, is acceptable if the application of such is directed to a useful, concrete and tangible result. b. Processes: In re Bilski The Federal Circuit held the useful, concrete and tangible result test for patentable subject matter enunciated in State Street Bank (supra) is inadequate for determining whether a process is patent eligible subject matter. In re Bilski, 545 F.3d 943 (Fed. Cir. 2008). The Bilski test for determining whether a process is patent-eligible subject matter looks to determine if the claimed process contains a machine or transformation. Furthermore, even if a claim recites a specific machine or a particular transformation of a specific article, the recited machine or transformation must not constitute mere insignificant post-solution or extra-solution activity. The Bilski holding is not limited to any particular type of process, but was limited by the Court to process claims, and specifically stated not to apply to non-process claims such as those upheld in State Street Bank. BPAI cases citing Bilski have been almost entirely involved claims to business methods or electronics. However, Classen v. Biogen, 2006 U.S. Dist. LEXIS 98106 (D. Md. Aug. 16, 2006), makes clear Bilski is not limited to business methods/electronics claims. 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). 4
Citing Bilski, BPAI opinions have held claims containing computer systems or computerreadable medium programmed to perform processes do not satisfy Bilski s machine or transformation test because the inclusion of the computer or computer-readable medium does not impose meaningful limits on the scope of the claimed processes. Involvement of the machine must not merely be insignificant extra-solution activity. Examples of extra-solution activity might include: displaying the results of a method on a monitor, retrieving data from a database, or executing a method from computer-readable medium. Similarly, process claims reciting a transformation are often dismissed by the Board because the transformation is insignificant extra-solution activity. Claims to methods of manipulating (transforming) data seem particularly susceptible to Bilski-type exclusion. i. Avoiding Bilski rejections Obviously, claims drafted to avoid Bilski-based exclusion would be drawn to machines, compositions, or articles of manufacture, avoiding process claims. 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 might not be sufficient. For the transformation prong, avoid relying solely on data transformation. Where possible, link data directly to a physical object or objects. For example, bone scans are data that directly represent the state of the bone, and can be output as a representation of the bone, e.g., on a display monitor. The more tangible the transformation, the better. c. Subject Matter To assist Examiners in making case-by-case determination of patent eligibility, the PTO published Interim Guidelines for the Examination of Patent Applications for Patent Subject Matter Eligibility on November 22, 2005. These Guidelines have not been updated in view of the Bilski case, but provide a general overview of the Examiner s approach to subject matter analysis. The 2005 Guidelines direct Examiners to first determine what the applicant has invented and is seeking to patent by reviewing the specification and claims. The Examiner is expected to conduct a thorough search of the prior art to facilitate the Examiner s understanding of the invention. The Examiner then engages in a two-stage analysis to determine if the subject matter being claimed is eligible for patenting. In the first stage, the Examiner determines whether the claimed invention complies with the subject matter eligibility requirements of 35 U.S.C. 101. Does the claimed invention fall within one of the four enumerated statutory classes: process, machine, manufacture or composition of matter? If the claimed invention appears to be within these four statutory 5
categories, the Examiner determines if the claims are nonetheless directed to mere abstract ideas, natural phenomena, or laws of nature. Claims that fail either of these tests are further analyzed to determine if eligibility is found in a transformation of an article or physical object to a different state or thing; or otherwise produces useful, concrete, or tangible result. Useful means simply having utility; a concrete or tangible result is reproducible. i. Prima facie Showing of Subject Ineligibility A proper rejection for unpatentable subject matter must include a prima facie showing that the claimed invention is either 1) statutory subject matter that is directed to mere abstract ideas, natural phenomena or laws of nature; 2) is non-statutory subject matter and in both cases fails to transforms an article or physical object to a different state or thing; and fails to produces useful, concrete or tangible result; or 3) in the case of processes, fails the machine-ortransformation test. 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. If the invention as set forth in the written description is statutory, but the claims are directed to ineligible subject matter, the Examiner should reject the claims, but identify the features of the invention that would render the claimed subject matter statutory. ii. Bilski Guidelines Under Bilski, if an invention falls into the process category, it should be further analyzed accordingly. In a memo dated January 7, 2009, Deputy Commissioner John Love outlined USPTO policy in light of Bilski. Examiners are to examine process claims using the machineor-transformation test. The memo provides the following instructions, [f]irst, a mere field-ofuse limitation is generally insufficient to render an otherwise ineligible method claim patenteligible. This means the machine or transformation must impose meaningful limits on the method claim s scope to pass the test. Second, insignificant extra-solution activity will not transform an unpatentable principle into a patentable process. This means reciting a specific machine or particular transformation of a specific article in an insignificant step, such a[s] [sic] data gathering or outputting, is not sufficient to pass the test. 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 claims, 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? Does the claimed invention produces useful, concrete, or tangible result? 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 6
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. 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. 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. 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 7
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. 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. 8
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. 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. 9
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. 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 10
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. 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 11
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 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. 12
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 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. 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: 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 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 13
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. 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 14
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 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 15
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 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 : 16
Wands factors for determining enablement 25 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 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? 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. 17
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 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. 18
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 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. 19