Responding to 101 and 112 Rejections. Marlan D. Walker TherapeuticsMD, Inc.

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1 Responding to 101 and 112 Rejections Marlan D. Walker TherapeuticsMD, Inc.

2 101 Rejections Patentable Subject Matter In recent years, the Court of Appeals for the Federal Circuit (CAFC) and Supreme Court took on many cases where the core issue was patent eligibility. Patent practitioners need to be well versed in patent eligibility, particularly because the United States Patent and Trademark Office (USPTO) Examiners often struggle to vet patent eligibility issues well. Thus, the patent eligibility issues lie dormant until litigation, when it is too late to address the issues that arise. This section addresses some of the important cases defining patent eligibility, with particular focus on recent cases, that every patent practitioner should familiarize themselves with. As one reads these cases, rather than focusing solely on the narrow holdings and tests defined in each case, it is important to understand the underlying principles. By understanding the principles that the CAFC and the Supreme Court use to arrive at their holdings, one will be better able to anticipate potential 101 issues in claims, even before seminal cases are decided, and thereby insulate the patents for future developments in patent eligibility law. Recent Important Cases The Supreme Court and Federal Circuit have taken an active role in defining the scope of 101. These cases are not comprehensive, but represent a cross-section of important cases. The holdings of these cases should be considered during client counseling, during claims drafting, and when responding to rejections. Gottschalk v. Benson In Benson, the Supreme Court considered claims to computer-implemented methods for converting binary coded decimal (BCD) numbers into binary numbers based on an algorithm. 1 The Supreme Court concluded that the claims were abstract. 2 The Court measured the scope of the claims against the scope of the abstract idea upon which the claims were based. The Court held that the claims covered every possible use of the BDC to pure binary conversion, both known uses and also uses that were at the time unknown. 3 Even though the method was tied to a 1 49 U.S. at Id. at Id. at

3 computer, the court held that the claim was really directed to the algorithm and the underlying mathematical formula. Thus, the claims were held to be non-patent eligible. 4 An exemplary claim found to be patent ineligible was: The method of converting signals from binary coded decimal form into binary which comprises the steps of: (1) storing the binary coded decimal signals in a reentrant shift register, (2) shifting the signals to the right by at least three places, until there is a binary `1' in the second position of said register, (3) masking out said binary `1' in said second position of said register, (4) adding a binary `1' to the first position of said register, (5) shifting the signals to the left by two positions, (6) adding a `1' to said first position, and (7) shifting the signals to the right by at least three positions in preparation for a succeeding binary `1' in the second position of said register. The C.C.P.A. laid out a test to ensure that claims are not directed to mathematical formulas or algorithm itself: 1. Does the claim directly or indirectly recited a mathematical formula or algorithm? 2. If an algorithm is recited, does it wholly preempt use of the mathematical algorithm? 5 If a mathematical formula is recited, one needs to be thoughtful about limiting it a specific machine or to otherwise meaningfully limit the claims to a specific application or use. Parker v. Flook In Parker v. Flook, 6 the Supreme Court considered the patent eligibility of a computerized process. The process at issue in Parker was a method for updating alarm limits for continuously monitored industrial process variables, such as temperature or pressure sensors, according to a mathematical formula. 7 Claim 1 reads: A method for updating the value of at least one alarm limit on at least one process variable involved in a process comprising the catalytic chemical conversion of hydrocarbons wherein said alarm limit has a current value of B0 + K wherein B0 is the current alarm base and K is a predetermined alarm offset which comprises: 4 Id. at In re Freeman, 573 F.2d 1237, (C.C.P.A. 1977) U.S. 584 (1978). 7 Id. at

4 (1) Determining the present value of said process variable, said present value being defined as PVL; (2) Determining a new alarm base B1, using the following equation: B1=B0(1.0-F) + PVL(F) where F is a predetermined number greater than zero and less than 1.0; (3) Determining an updated alarm limit which is defined as B1 + K; and thereafter (4) Adjusting said alarm limit to said updated alarm limit value. Even though the claim did not wholly preempt the mathematical formula, 8 the Court held that the claim was directed to an abstract idea and therefore patent ineligible. In finding the claim to be patent ineligible, the Court stated if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is nonstatutory. 9 Diamond v. Diehr The claims at issue in Diamond v. Diehr 10 were directed to the use of a mathematical formula and a programmed digital computer. 11 The claimed methods included steps for operating a rubber molding press that determined the temperature inside the mold, iteratively calculated the cure time using the Arrhenius equation, and opened the press whenever the elapsed cure time equaled the calculated necessary cure time: A method of operating a rubber-molding press for precision molded compounds with the aid of a digital computer, comprising: providing said computer with a data base for said press including at least, natural logarithm conversion data (ln), the activation energy constant (C) unique to each batch of said compound being molded, and a constant (x) dependent upon the geometry of the particular mold of the press, initiating an interval timer in said computer upon the closure of the press for monitoring the elapsed time of said closure, constantly determining the temperature (Z) of the mold at a location closely adjacent to the mold cavity in the press during molding, constantly providing the computer with the temperature (Z), repetitively calculating in the computer, at frequent intervals during each cure, the Arrhenius equation for reaction time during the cure, which is 8 Id. at Id at quoting In re Richman, 563 F.2d 1026, 1030 (CCPA 1977) US 175 (1981). 11 Id. at 177.

5 ln v=cz+x where v is the total required cure time, repetitively comparing in the computer at said frequent intervals during the cure each said calculation of the total required cure time calculated with the Arrhenius equation and said elapsed time, and opening the press automatically when a said comparison indicates equivalence. The Supreme Court held the claims to be patent eligible and differentiated over Benson and Parker. The claims in Diehr employed a mathematical concept but did not seek to preempt the use of that equation. Rather, they [sought] only to foreclose from others the use of that equation in conjunction with all of the other steps in their claimed process. 12 Importantly, the Court held that an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection. 13 Bilski v. Kappos In Bilski v. Kappos, 14 the Supreme Court's considered business methods. The Supreme Court held that Bilski's claims directed to hedge fund risk management were patent ineligible under 35 U.S.C However, the court did not rule out business methods altogether, provided the claims are not directed to an abstraction. One relevant claim in Bilski s patent application read: 1. A method for managing the consumption risk costs of a commodity sold by a commodity provider at a fixed price comprising the steps of: (a) initiating a series of transactions between said commodity provider and consumers of said commodity wherein said consumers purchase said commodity at a fixed rate based upon historical averages, said fixed rate corresponding to a risk position of said consumer; (b) identifying market participants for said commodity having a counterrisk position to said consumers; and (c) initiating a series of transactions between said commodity provider and said market participants at a second fixed rate such that said series of market participant transactions balances the risk position of said series of consumer transactions. 12 Id. at Id. 14 Bilski v. Kappos, 130 S. Ct (U.S. 2010).

6 Prior to the Supreme Court's decision, the Federal Circuit changed the standard used to determine whether claim drawn to a business method was eligible under 101. The Federal Circuit promulgated the machine or transformation test, which required the method to be tied to a machine or result in a transformation. The Supreme Court declined ratification of the Federal Circuit's test, but didn't eliminate it altogether. Rather, the Court held that there is no one test for determining whether the claims are drawn to an abstraction. Indeed, the court held the machine or transformation test was a useful and important clue, 15 but not the only test for deciding whether a method is patentable. Practically, however, without a bright line test, the USPTO will continue to rely on the machine or transformation test, and will be loath to allow applications that do not meet the criteria of that test. Mayo v. Prometheus Mayo Collaborative Services v. Prometheus Labs, Inc. 16 decided the issue of whether personalized dosing regimens that evaluated the correlations between the concentration of certain blood metabolites and the potential harm of the drug thiopurine. In a unanimous decision, the Supreme Court held that methods that claim natural correlations are patent ineligible. In essence, the court held that newly discovered natural laws are patent ineligible and the application of the newly discovered law is also patent ineligible if it merely relies on elements that are already known in the art. The relevant claim: A method of optimizing therapeutic efficacy for treatment of an immunemediated gastrointestinal disorder, comprising: (a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and (b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder, wherein the level of 6-thioguanine less than about 230 pmol per 8x10 8 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the level of 6-thioguanine greater than about 400 pmol per 8x10 8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject Id. at Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct (U.S. 2012). 17 U.S. Pat. No. 6,355,623, claim 1.

7 The claim prohibition is the claiming of the correlation itself. According to a memorandum promulgated by the USPTO in response to Mayo, a claim is patent eligible where it provides additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations. 18 Conversely, a claim is patent ineligible if it claims a law of nature (e.g., a correlation that exists in nature) without those additional features. Special care is warranted if method claims are directed to phenomena that exist in nature, even if the phenomena is newly discovered. It is important to add additional features or claim the subject matter in the context of a machine or apparatus or add additional, meaningful steps to apply of the natural law in a specific way. Another potential way of drafting a similar claim to be patent eligible is to tie it to a method of treatment. 19 AMP v. Myriad In June 2013, the Supreme Court decided to what extent human genes are patentable. In a unanimous decision, the Court held that gene claims are patentable, provided they are not directed to isolated DNA. Specifically, cdna is patentable because cdna is not naturally occurring (unless the claimed cdna has base-pair per base-pair genomic analog). One of the claims in Myriad found to be directed to patent ineligible subject matter: An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2. 20 The Court noted that the claim was drawn to the information contained in the gene. Thus, the act of merely taking the gene out of the genome is not inventive and makes the resulting isolated DNA patent ineligible. 21 The Court held, however, that cdna is patent eligible, provided the cdna sequence is not naturally occurring (i.e., has at least one intron that is removed, for example). Because a cdna with the introns removed is not found in nature, it is patent eligible Memorandum from Andrew H. Hirshfeld, Associate Commissioner for Patent Examination Policy, to the Patent Examining Corps (Mar. 21, 2012) (available at 19 Kevin E. Noonan, Mayo Collaborative Services v. Prometheus Laboratories -- What Should We Do? (Or Can These Claims Be Saved?)(March 26, 2012), available at 20 U.S. Pat. No. 5,747, Myriad at Id. at

8 It is noteworthy to point out that Myriad does not opine on methods or uses of genes or methods of deriving genes. 23 The Court also did not opine on intentional, non-naturally occurring alteration of genes. 24 CLS Bank v. Alice Corp The holding in CLS Bank v. Alice Corp. 25 represents the first shot over the bow of software patents. In a plurality decision, the CAFC decided that certain method and computerreadable medium claims are patent ineligible subject matter. 26 As an en banc plurality opinion, CLS Bank has questionable precedential value, but it is noteworthy because of its potential impact on software patenting. Certainly, it will be worthwhile to monitor the cases that follow this case. Patent practitioners should thoughtfully attempt to claim methods and specific purpose computing platforms as fall back positions. It is noteworthy to point out the underlying methods were held to be abstract. Rather than citing specific claims (there were method, system, computer-readable media claims), the per curiam opinion stated: Upon consideration en banc, a majority of the court affirms the district court s holding that the asserted method and computer-readable media claims are not directed to eligible subject matter under 35 U.S.C An equally divided court affirms the district court s holding that the asserted system claims are not directed to eligible subject matter under that statute. 27 CLS Bank represents a drastic retreat from the prior body of law that held that computerreadable media and system claims were generally patent eligible under 101. Depending on how the Courts, particularly the Federal Circuit and Supreme Court, handle the cases that follow will inform patent practitioners exactly what this opinion means for software patenting, and whether with less abstract subject matter the court will see computer-readable media and software claims differently. Addressing Examiner Rejections Experienced patent practitioners repeatedly see the same basic 101 rejections from Examiners. Generally, these rejections require amendment or cancellation of claims or require nuanced arguments to overcome the rejections. The sections that follow address various grounds 23 Id. at Id. at CLS Bank Int'l v. Alice Corp. Pty, 106 USPQ.2d 1696, 2013 U.S. App. LEXIS 9493 (Fed. Cir. 2013). 26 Id. 27 Id. at *6-*7 (emphasis added).

9 upon which an Examiner will reject the claims and outline the standards to consider when formulating a response. Business (Abstract) Methods and Software For business methods and software, abstractness is the general issue that arises most often in the context of 101 rejections. After Bilski, however, the standard is a highly ambiguous. The USPTO continues to use the machine-transformation test as the bellwether and shifts the burden to the applicant to argue machine, transformation, or some other argument of non-abstractness, which from a practical standpoint does not exist. Thus, if the claims are not tied to a machine or result in a transformation, the patent practitioner may have a difficult, uphill battle to get the claims allowed. Machine Prong To successfully meet the machine prong of the machine or transformation test, the claimed method must be tied to a machine or other tangible structure, which the claim will then be limited to. Examiners look at the following factors when evaluating if the machine prong is met: (a) the particularity or generality of the elements of the machine or apparatus; (b) whether the machine or apparatus implements the steps of the method; and (c) whether the machine s involvement imposes meaningful limits on the execution of the claimed method (e.g., whether the method covers an entire field). 28 Prior to CLS Bank s shot over the bow of software patenting, the simple fix for method claims rejected under 101 was to recite that the claims were performed on a general purpose computer, which the MPEP states is specifically sufficient. Thus, introducing a computer into the claim will overcome the objection based on the machine prong. Beware, however, that unless the specification supports performing the method on a computer, the claim amendment might not be entered. Typically, the computer-related disclosure are boilerplate paragraphs with a simple statement in the specification that the described method can be performed on a general purpose computer or can be put on a machine readable media. Transformation Prong The transformation prong is a more difficult argument to win during prosecution compared to the machine prong, mostly because it is much more subjective. The MPEP provides instructive help as to what constitutes a transformation. According to the MPEP, the following factors determine are weighed to determine if a transformation exists: (a) the particularity or generality of the transformation; 28 Manual of Patent Examining Procedure (MPEP) 2106(II)(B)(1)(a).

10 (b) the degree to which the recited article is particular (e.g., transformation applied to a general recited article weighs against patent eligibility); (c) the nature of the transformation in terms of the type or extent of change in state or thing (e.g., changing the function or use of the thing, which weighs in favor of eligibility); (d) the nature of the article transformed (objects/substances are weighted towards patent eligibility, whereas concepts are not); (e) whether the method imposes meaningful limits on the execution of the claimed method (does the claimed method cover an entire field). 29 Particularly in business method and software cases, the transformation prong is a very difficult argument to make and win. Therefore, for business methods and software patent applications, it is critical to make sure that machines are disclosed in the specification as a fallback position. In all cases, one must carefully consider the claim language for method claims and ensure that the claim results in a transformation. Abstractness The Supreme Courts holding under Bilski left open the opportunity to make other arguments when the machine or transformation test cannot be met. In practice, however, a patent practitioner should temper expectations when arguing generic abstractness. Examiners judge abstractness in the absence of a machine or transformation based on this criteria: if the method recites an application of a law of nature, provided the method is narrow in scope, a claim is patent eligible if the steps do not solely involve subjective determinations, and the method does not preempt an entire field. 30 The subjective nature of this standard makes pure legal argument hard to win. If the claim recites a general abstract concept, patent practitioners will have difficulty winning the nonabstractness argument. Odds are good that Examiners will not accept non-abstractness arguments, unless convincing extrinsic evidence is presented. Software Patent practitioners have developed clever ways to patent software. Three principle claim drafting techniques are used to protect software innovation: computer-readable media claims; special purpose machine claims, and system claims. However, as discussed above, after Alice Corp., the Federal Circuit cast a shadow over whether these clever ways to address software will remain viable in the future. Computer-readable media claims are directed not to the software itself, but to an article of manufacture that contains the software (i.e., computer executable instructions). Instead of writing a method claim, the claim preamble begins with something similar to: A computer-readable 29 MPEP 2106(II)(B)(1)(b). 30 Id.

11 medium containing instructions thereon executable by a computer, the instructions comprising... The balance of the claim then recites the steps as if the claim were a method claim. Examiners will often reject these claims as being abstract and require that the patent practitioner amend the claim to recite a computer or other machine if one isn t recited originally. In such a case, it is imperative that the specification contains the requisite disclosure to make the amendment. If computer-readable media claims are included, the computer-related stock language is generally already disclosed, and a claim amendment can typically be made. However, it is always good practice to direct the Examiner's attention to a location in the specification where the specific method has been disclosed as intended to be executed on a machine. Better yet, a wise patent practitioner will draft the claim with a machine built into it the software instructions cannot be executed in the absence of a computer anyhow, so there is typically little downside in drafting a machine into the claim in the first place. Special purpose machine claims are similar to computer-readable media claims in the sense that they disclose a series of steps for a computer to execute as the primary thrust of the claim. Where these claims differ, however, is that they are claimed in the context of a specific machine. For example, a manufacturing robot can have novel software that controls how it performs. In this case, the claim is directed to the specific robot and the software that controls the robot. If such a special purpose computer is disclosed in the specification, Examiner rejection under 101 can be readily overcome by amending the claims to the special purpose machine. Finally, system claims claim software in the context of a more general system. System claims range from specific to abstract. Abstract system claims generally must be amended, typically to recite a machine (the temptation to argue transformation of the data is always present and should be avoided as this argument is unlikely to do anything more than irritate the Examiner). Correlation Claims--Personalized Medicine After Mayo, methods that depend on a correlation are highly likely to be rejected unless they claim more than just the recitation of a natural correlation. The Examiner reviews correlation claims based on three criteria: (a) Is the claim a method? (if so, the Examiner also reviews it under the machine/transformation/abstractness criteria explained above); (b) Does the claim focus on use of a law of nature, a natural phenomenon, or naturally occurring relation or correlation? (c) Does the claim include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural

12 principle is practically applied, and are sufficient to ensure that the claim amounts to significantly more than the natural principle itself? 31 If a correlation claim is rejected, the patent practitioner should review the specification to see if additional steps can be included so that the recited method does not solely claim a law of nature or to reclaim the steps in the context of some tangible object or machine. The patent practitioner may have to be creative in the way that these methods are drafted or amended. For example, one possibility is to redraft the claims as an apparatus claim. In every case, however, the claim will be vulnerable to rejection or later litigation challenges if the claim primarily recites a law of nature. Isolated DNA Patent practitioners have no choice but to amend or cancel isolated DNA claims per Myriad, but only if the isolated DNA is naturally occurring (lab made or artificially modified gene DNA continues to be patentable). In cases where the claim to isolated DNA is naturally occurring (or cdna that has a naturally occurring analog i.e., the particular cdna did not have introns removed), the patent practitioner must amend or cancel these claims and rely on other methods of claiming these types of DNA (e.g., in conjunction with a microarray or as part of a diagnostic kit, for example). Because Myriad was just decided, it will take some time for the courts to fully flesh out the metes and bounds of what sort of DNA claims are permissible. In all cases, the claim set should be amended with an eye to fallback positions that will provide a modicum of value to the client. The patent practitioner may not know whether specific DNA sequences provided by a client are directed to cdna or isolated DNA. In these cases, it is important to discuss with the inventors the patenting guidelines to ensure that the claims do not claim patent ineligible subject matter. Indeed, the patent office may not have any reasonable way to determine if a given sequence is cdna, isolated DNA, or other DNA sequences, and an error will only be discovered in the courtroom. Declaration Practice Rejections under 35 U.S.C. 101 do not have an appreciable declaration practice, except in cases where the patent practitioner needs to provide extrinsic regarding what the specification discloses or to address subjective standards. In these cases, a declaration can be used to establish intrinsic or implied disclosure, for example, or to address factual disputes regarding to scope of the disclosure. Patent practitioners can also use declarations or affidavits to address subjective issues. Declarations are also potentially useful under the standard promulgated by the Supreme Court in Myriad with respect to whether a DNA sequence is naturally or non-naturally occurring, or whether the gene encoding a claimed cdna had introns that are removed. 31 MPEP (II).

13 112 Rejections Changes to 112 under America Invents Act The America Invents Act (AIA) amended section 112. Generally, the changes were cosmetic. The sections were given sub-section headings, which alleviates the need to refer to the specific portion of section 112 by paragraph number, which was the prior practice. Additionally, AIA updated the terminology in sections 112(a) and 112(b) to refer to the inventor or joint inventor. The text of section 112 after AIA: 35 U.S.C. 112 Specification. (a) IN GENERAL.--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 or joint inventor of carrying out the invention. (b) CONCLUSION.--The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. (c) FORM.--A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form. (d) REFERENCE IN DEPENDENT FORMS.--Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. (e) REFERENCE IN MULTIPLE DEPENDENT FORM.--A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.

14 (f) ELEMENT IN CLAIM FOR A COMBINATION.--An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The redline below shows the changes introduced to 112 by AIA relative to the prior version. 35 U.S.C. 112 Specification. (a) IN GENERAL.--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 or joint inventor of carrying out histhe invention. (b) CONCLUSION.--The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicantthe inventor or a joint inventor regards as histhe invention. (c) FORM.--A claim may be written in independent or, if the nature of the case admits, in dependent or multiple dependent form. (d) REFERENCE IN DEPENDENT FORMS.--Subject to the following paragraph,subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. (e) REFERENCE IN MULTIPLE DEPENDENT FORM.--A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered. (f) ELEMENT IN CLAIM FOR A COMBINATION.--An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.

15 As is readily observed, AIA modification to 112 were largely cosmetic, most notably being the addition of sections letter for the paragraphs and headers. Other notable changes include a change to the inventor or joint inventor, which refers to an inventor or co-inventors and individually created inventions or a collectively created joint invention. 32 Specification-Related Rejections Various specification-related rejections can be made under 112. With the exception of enablement and written description flaws, 112 objections and rejections are generally easily resolved. The initial focus of this section will be what is required to meet and overcome enablement and written description rejections. Enablement The enablement requirement is a subjective determination whether the specification provides enough detail to enable a person of ordinary skill in the art to make and use the claimed invention. Specifically: 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 or joint inventor of carrying out the invention. 33 Thus, patent practitioners should consider remedial drafting in the specification; in other words, describe every important element in the invention in detail, providing alternatives and principles in how a person of ordinary skill in the art would go about selecting, including, omitting, or using that element, and how that element interacts with other inventive elements. Err on the side of being over-inclusive when giving the required sufficient detail to allow an artisan to make and use the claimed invention. An important point to remember for enablement is that actual reduction to practice is not required. The amount of detail required varies depending on the technology field, the predictability, maturity of the technologies involved, and the complexity. While a variation of a common widget may require only a brief description of the shape, size, building material, and intended use, a new chemical moiety may require a detailed description of the synthesis of the molecule or U.S.C U.S.C. 112(a) (emphasis added).

16 the method of isolating it, as well as a description of how the new molecule can be used and what it will be used for. Enablement Rejections Enablement rejections typically occur in two situations, both situations reflecting a disconnect between the scope of the claims and the scope of the specification. In the first situation, the specification fully supports the intended invention, but drafted claims are overbroad. In this situation, a narrowing amendment of the claims will remedy the enablement problem. Because of prosecution history estoppel, however, the better solution is to draft reasonable claims prior to examination. In the second situation, the specification itself is flawed and does not enable the intended invention. Patent practitioners must be extremely careful not to have this problem this is a function of careless patent drafting and in some cases cannot be remedied because of intervening art. If an enablement rejection is made that would otherwise require narrowing of the claims such that the resulting claims cannot adequately protect the intended invention, the only recourse is to refile the utility application as a continuation-in-part or a new utility application. In some cases, the Examiner makes an incorrect enablement determination of the amount of disclosure that a person of ordinary skill in the art would need to make and use the invention. The standard by which the Examiner makes this determination is whether undue or unreasonable experimentation would be needed to make and use the claimed invention. The Examiner makes the determination of whether the level of experimentation is undue based on the Wands factors: 34 The breadth of the claims; The nature of the invention; The state of the prior art; The level of one of ordinary skill; The level of predictability in the art; The amount of direction provided by the inventor; The existence of working examples; and The quantity of experimentation needed to make or use the invention based on the content of the disclosure. 35 Each of these factors are highly subjective. The analysis becomes even more subjective because the Examiner is required to subjectively balance each of the subjective factors. In real practice, Examiner s typically provide reasoning under each of the factors, but rarely cite evidence to support their supposition of undue experimentation based on the Wands factors, which often In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Id.; MPEP (a).

17 make flawed enablement rejections onerous to address. Providing evidence in the form of declarations or other intrinsic evidence is often necessary to overcome these rejections. Overcoming Flawed Enablement Rejections with a Declaration In actual practice, once the Examiner incorrectly determines that a claim is not enabled because it would require undue experimentation, it is difficult to argue the Wands factors without the use of extrinsic evidence. In these cases, declarations under 37 CFR are useful as extrinsic evidence to rebut the Examiner s application of the Wands factors. In such declarations, a person of ordinary skill in the art (ironically referred to as experts ) can address the Wands factors. Typically, the more experts who will declare favorably with respect to the Wands factors, the more likely the Examiner will retreat from the lack of enablement position, and once enablement is dealt with, it is unlikely to surface as a substantive issue again unless the claims are unreasonably broadened. Written Description Like enablement, the written description requirement is found in 35 U.S.C. 112(a): 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 or joint inventor of carrying out the invention. 36 Written description is a gatekeeping requirement that demonstrates that the inventors have adequately disclosed their invention to the public for the limited right to exclude granted by the patent. During examination, the Examiner will evaluate a claim and determine if the specification contains an adequate description of the claimed subject matter. 37 According to MPEP , the Examiner will ask, does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed. 38 Original claims are granted a strong presumption of adequate written description. 39 Not so for amended or claims presented during prosecution. These later filed claims will be scrutinized more closely by the Examiner to ensure that they are supported by written description U.S.C. 112(a) (emphasis added). 37 MPEP MPEP , citing In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ.2d 1614, 1628 (Fed. Cir. 1989); for certain biotechnology applications, the deposit of a physical specimen can bolster the written description. 39 MPEP 2163(A).

18 in the specification. 40 Indeed, because claims are more often narrowed during prosecution than broadened, it is important to have written description that will support the narrowing of the claims, and helpful to recite where the written description exists in the specification to support the amendments. As discussed below, the narrowing problem can be quite a nuisance to a patent practitioner when trying to narrow for a genus to a species, or in some cases when trying to broaden from a species to a genus. The written description requirement is closely related to yet distinct from the enablement rejection. Many patent practitioners who are beginning their careers struggle to come to grips with the difference between the written description requirement and the enablement requirement. Indeed, the written description requirement is the gate-keeping function that the specification contains the quid pro quo required by the patent statute: full public disclosure in exchange for limited exclusivity. The enablement requirement is the more substantive analysis that asks whether the disclosure adequately teaches a person of ordinary skill in the art how to make and use the invention. Practically, a robust specification that enables the invention will also satisfy the written description requirement. However, the temptation is to omit disclosure that the patent practitioner might assume would be clear to a person of ordinary skill in the art, which will lead to trouble on the written description side. The more insidious issue with written description are the pesky issues of genus and species. Genus-Species Problems An inherent paradox exists in the written description requirement that each patent practitioner must come to peace with: narrower, species claims may not be supported by a specification that broadly supports broader, genus claims. In other words, when faced with a rejection over a broad species, the patent attorney may not be able to narrow the claims to specific species if those species are not specifically disclosed in the specification. To provide the ability to narrow to species claims, one should always ask the inventor to provide as many examples of species as possible to be included in the patent application. Additionally, by providing guidance in the specification that dictates the metes and bounds of the species that are anticipated by the specification and teaches how to make, identify, and use the species (i.e., providing principled guidance), a patent practitioner may later have the ability to argue that a person of ordinary skill would read the specification to encompass the specific species. This type of disclosure is useful during development of the invention, when specific examples are not yet reduced to practice, or when the patent practitioner want to expand the scope of potential claims to bootstrap future innovation in the inventive area. 40 MPEP 2163(B).

19 Written Description Rejections Examiners ask a series of questions to verify that the specification contains adequate written description: 1. For each claim, determine what the claim as a whole covers; 2. Review the entire application to understand how applicant provides support for the claimed invention including each element or step; 3. Determine whether there is sufficient written description to inform a skilled artisan that applicant was in possession of the claimed invention as a whole at the time the application was filed. 41 It is noteworthy to point out that the third step further contains a rigorous methodology for determining whether sufficient written description exists between genus and species claims, which patent practitioners are encouraged to study in MPEP Often, when presented with a written description rejection, the patent practitioner need only direct the Examiner's attention to the location in the specification that discloses the alleged lack of description. In fact, the practitioner can even allege that the subject matter is implicit or inherent in the specification (but one is always better off relying on express disclosure). 42 A word of warning, however: specifications that do not contain requisite written description cannot usually be cured because new matter cannot be added. Two narrow exceptions will allows for amendment of the specification: if the lack of written description is an inherent function, theory, or advantage; 43 or if adequate written description is contained in a properly incorporated by reference document. But beware of reliance on incorporated by reference documents. They may make the drafting of the specification easier and faster, but there are dangerous pitfalls. 44 Overcoming Flawed Written Description Rejections with a Declaration Like enablement, written description is based on what a person of ordinary skill in the art would have known. For example, a patent practitioner need not explain that a widget can be installed in a machine with a bolt a person of ordinary skill in the art will know that. Thus, if an 41 MPEP MPEP 2163(b). 43 MPEP (a). 44 MPEP (b). It is worthwhile for patent practitioners to thoroughly understand what can and cannot be incorporated by reference (MPEP 2181). I have often observed patent attorneys (both inexperienced and experienced) assuming they can fall back on incorporated by reference materials if there is a written description problem. The patent office, however, does not vet the sufficiency of what is incorporated by reference, and a mistake in incorporation by reference can be a costly one for your client during prosecution or litigation. Where in doubt with an incorporation by reference document, copy the relevant text into your specification!

20 Examiner asserts lack of written description, a declaration under 37 CFR can be used to introduce evidence that the subject matter at issue is conventional or would be known to the person of ordinary skill in the art. According to MPEP 2163, [w]hat is conventional or well known to one of ordinary skill in the art need not be disclosed in detail. 45 If a person of ordinary skill in the art will recognize what has been invented based on the specification, the written description requirement is met. 46 Best Mode After the passage of AIA, best mode became a hot topic in the patent community as AIA did away with best mode as a patent infringement defense. Prior to AIA, failure to provide best mode in a patent was grounds for invalidation of an issued patent. Congress removed as a defense to patent infringement the failure to disclose best mode in a patent application, and many patent practitioners questioned whether disclosure of best mode was still required. Under 112, the best mode requirement survives. Prudence dictates that one will make sure to disclose the best mode in the specification until Congress or the courts provide additional clarity. As a practical note, a patent practitioner does not have an obligation to point out which embodiment the inventors consider the best mode, just that the best mode is disclosed somewhere in the patent application. Claims Form Objections and Rejections Distinct Claims Section 112 requires that the patent application to conclude with a set of claims: (b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. 47 The claims are required to particularly point out and distinctly claim the invention. Typically, claims will be presumed to claim the inventor s invention, unless the inventor makes statements to the contrary. The standard that the Examiner uses to determine if the distinct claiming requirement is met is whether the claims are clear and precise. As a drafting note, using consistent terminology from specification to claims goes a long way to help the Examiner understand the scope of the claims, and makes the response easier because a patent practitioner 45 MPEP MPEP U.S.C. 112(b).

21 can rely on the specification to point out why terms are clear, where the terms are formally defined, and so forth. Indefiniteness rejections are common. They are made when the claim terms fail to recite clear metes and bounds. Terminology such as about, substantially, essentially, similar, and like terms are often flagged as indefinite. Likewise, the failure to recite proper antecedent basis can create ambiguities. Note: the actual application of indefinite varies between Examiners. For example, some Examiners will allow the term about, while other Examiners will issue a rejection over the term. Thus, as a drafting practice, practitioners will make sure to carefully define important terms. As part of the Examiner s examination of the case, the Examiner will review the claims to ensure that they are clear and unambiguous. Generally, claim rejections under 112 are based on form versus substance. Often, the Examiner will propose solutions to be adopted by the Applicant. If the rejection is not clear, a call to the Examiner will generally lead to constructive discussions to correct the perceived problems, and will often allow the practitioner to have a chance to discuss other substantive issues with the case with the Examiner that will be helpful in the preparation of the response. Means + Function Claims Sometimes, means plus function claims are rejected if the Examiner cannot clearly tell what the means for describes. These objections/rejections are typically easy to overcome as a statement on the record or slight modification of the claim language will suffice for a response. Typically, a call to the patent Examiner is useful to identify Examiner's issue and how the Examiner wants the issue to be handled. Patent practitioners should consider substantive responses rather than cancellation of the claims. If claim amendments elsewhere are required, prosecution history estoppel may affect the scope of the claims. Section 112(f), however, provides a secondary way to potentially preserve equivalents, even with claim amendments, because means + function equivalents are granted under the statute:... such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof." Thus, one can reasonably argue that even if the claims are amended and prosecution history estoppel attaches, the equivalents granted in 112(f) may still exist despite the prosecution history estoppel because the equivalents were granted by statute (as opposed to be the doctrine of equivalents arising out of the case law).