United States Markush Practice in Flux. Brian K. Lathrop, Ph.D., Esq. April 3, 2012

Transcription

1 United States Markush Practice in Flux Brian K. Lathrop, Ph.D., Esq. April 3, 2012

2 Disclaimer > The views presented here are my own and should not be attributed to Drinker Biddle & Reath LLP, its clients, or AIPLA. United States Markush Practice in Flux April 3,

3 A Word About Markush Claims > Markush claims are commonly used in the pharmaceutical and biotechnology industries as an alternative to defining a genus of related molecules solely by function. > They pose unique problems of search and examination. For a history of the development of Markush practice, see Brief for Comm r Patents Trademarks, In re Harnisch, 631 F.2d 716 (No ) (1980). United States Markush Practice in Flux April 3,

4 Outline > Current thinking about Markush claims at the USPTO. Ex parte De Grado. (4 slides) 112 Guidelines and the new unity of invention rejection. (7 slides) > What can the community do? Enforcement. (2 slides) Problem Solving. (7 slides) > A Final Word. (1 slide) United States Markush Practice in Flux April 3,

5 Current thinking about Markush claims at the USPTO > Ex parte De Grado. (4 slides) > 112 Guidelines and the new unity of invention rejection. (7 slides) United States Markush Practice in Flux April 3,

6 Ex parte De Grado (1) > Case law interpreting [ 121], however, has held that the provisions of the second paragraph of 35 U.S.C. 112 are superior to the Director s discretion under 121 to restrict the application to a single invention where independent and distinct inventions are presented in a single claim. Ex parte DeGrado, Application 10/801,951, Appeal , Order for Further Briefing, at *10 (Bd. Pat. App. Int. May 9, 2011) (relying on In re Weber, 580 F.2d 455, 458 (C.C.P.A. 1978); emphasis added). United States Markush Practice in Flux April 3,

7 Ex parte De Grado (2) > In re Harnisch, 631 F.2d 716 (C.C.P.A. 1980) notes that the body of law relating to Markush-type claims is concerned with the concept of unity of invention. Harnisch, 631 F.2d at 721. The court used unity of invention to refer to the situation where unrelated, i.e., independent and distinct, inventions are captured in a single claim. Id., at *11 (citing In re Harnisch, 631 F.2d 716, 722 (C.C.P.A. 1980); emphasis added). United States Markush Practice in Flux April 3,

8 Ex parte De Grado (3) > A Markush claim is improper if the inventions (1) do not share a common use; or (2) do not share a single structural similarity, that is, a substantial structural feature disclosed as being essential to the common utility. Id., at *11 (citing Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984); emphasis added). United States Markush Practice in Flux April 3,

9 Ex parte De Grado (4) > What the USPTO is telling us: 1. restriction requirements are not permitted for Markush claims; 2. the CCPA s precedential standard for unity of invention is whether the claimed inventions are unrelated, i.e., independent and distinct; and 3. the Board uses an entirely different standard. United States Markush Practice in Flux April 3,

10 Director s Guidelines (1) > The USPTO published new guidelines for examining Markush claims: Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 Fed. Reg. 7162, 7166 (February 9, 2011) ( Guidelines ); > This is a significant departure from the USPTO s proposed now dead Markush rules. United States Markush Practice in Flux April 3,

11 Director s Guidelines (2) > The Guidelines are not directed to a specific technology or Art Unit: A Markush claim recites a list of alternatively useable species. Guidelines, 76 Fed. Reg. at United States Markush Practice in Flux April 3,

12 Director s Guidelines (3) > Examiners shall substitute restriction requirements with species elections: Under principles of compact prosecution, the examiner should also require the applicant to elect a species or group of indistinct species for search and examination (i.e., an election of species). Id. (citing MPEP ). United States Markush Practice in Flux April 3,

13 Director s Guidelines (4) > Rejoinder and Extended Search: If the elected species is allowable the examiner must rejoin species and extend the search. Id. (citing MPEP ). United States Markush Practice in Flux April 3,

14 Director s Guidelines (5) > Unity of Invention Rejection: When an examiner determines that the species of a Markush group do not share a single structural similarity or do not share a common use, then a rejection on the basis that the claim contains an improper Markush grouping is appropriate. Id. United States Markush Practice in Flux April 3,

15 Director s Guidelines (6) > Rejection Stops the Extended Search: If the examiner does not find the species or group of indistinct species in the prior art, then the examiner should extend the search to those additional species that fall within the scope of a permissible Markush claim. Id. (emphasis added). United States Markush Practice in Flux April 3,

16 Director s Guidelines (7) > Not Specific to a Technology or Art Unit > Species Elections > Rejoinder and Extended Search > Unity of Invention Rejection > Rejection Stops the Extended Search United States Markush Practice in Flux April 3,

17 What can the community do? > Enforcement. (2 slides) > Problem Solving. (7 slides) United States Markush Practice in Flux April 3,

18 Enforcement (1) > The USPTO is a federal agency. Its actions are reviewed under the Administrative Procedures Act. See Dickinson v. Zurko, 527 U.S. 150, 152 (1999). > A court will find unlawful any agency action that is arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. 5 U.S.C. 706(2)(A). United States Markush Practice in Flux April 3,

19 Enforcement (2) > The USPTO top level management indicates its intention to act consistently with the law and its own MPEP. > Failure of individual examiners or Art Units to follow their own guidance could be held unlawful as arbitrary and capricious. See Patlex Corp. v. Mossinghoff, 758 F.2d 594, 606 (Fed. Cir. 1985) (The MPEP is made available to the public and... describe[s] procedures on which the public can rely. ); MPEP Forward (examiners follow guidance from their Director). United States Markush Practice in Flux April 3,

20 Problem Solving (1) > Assuming enforcement of the Guidelines, however, the Examiner has no good options: 1. Restrict the Markush group (unlawfully), but have the requirement reversed on petition; risk losing a count for the first Office Action on the merits. 2. Require a species election, but be faced with an essentially endless extended search; risk failing to meet pendency and production requirements. 3. Allow the claim without a full search of the genus, without clear USPTO guidance as to how many species must be searched to ensure quality examination. 4. Reject the claims for lack of unity of invention and be done with the whole problem. United States Markush Practice in Flux April 3,

21 Problem Solving (2) > Working with the USPTO: 1. Does Applicant really need a Markush claim at all? 2. A preliminary amendment to reduce the number of recited embodiments (~6-10?) provides a powerful incentive for the Examiner to issue a species election, as opposed to a restriction requirement or unity of invention rejection. United States Markush Practice in Flux April 3,

22 Problem Solving (3) > But there will be some inventions that can only be claimed with a large Markush group, and that cannot be claimed if a restriction is made. What then? 1. Can stakeholders live with less than all species examined? Cf. Weber (USPTO has the discretion to determine how much searching it will do for a single fee). 2. Can Applicants work with the Examiner to provoke a unity of invention rejection, as opposed to a restriction requirement? United States Markush Practice in Flux April 3,

23 Problem Solving (4) > Why would we want to provoke a unity of invention rejection!? The standard for unity of invention is unsettled and in need of clarification. Whether a Markush claim has unity of invention does not depend on the number of recited species. United States Markush Practice in Flux April 3,

24 Problem Solving (5) > Under the AIA, the Patent Trial and Appeal Board soon will have jurisdiction to review unity of invention during PGR. Petitioner may assert any basis for invalidity (except failure to disclose best mode), including a novel or unsettled legal question that is important to other patents or patent applications. 35 U.S.C United States Markush Practice in Flux April 3,

25 Problem Solving (6) > Could Harnisch and Hozumi produce different results? A DNA array comprising a plurality of probes. The probes are related if there is a disclosed functional relationship between them. See MPEP Would unity of invention be found under Harnisch? But do the probes share a substantial structural feature essential to utility? Would unity of invention be found under Hozumi? United States Markush Practice in Flux April 3,

26 Problem Solving (7) > Could an issued Markush claim reciting just two species even if related be found invalid during PGR under the USPTO s Hozumi standard? > Is this a new due diligence issue? > This issue can now be raised through the Board to the Federal Circuit, which could be an advantage over district court review under APA (e.g., $$). United States Markush Practice in Flux April 3,

27 A Final Word > A Conversation Long Overdue Having recognized the possibility of rejecting a Markush group type of claim on the basis of independent and distinct inventions, the PTO may wish to anticipate and forestall procedural problems by exercising its rulemaking powers under 35 USC 6(a), wherein the views of interested parties may be heard. In re Harnisch, 631 F.2d 716, 722, n.7 (C.C.P.A. 1980). Even though the statute allows the applicant to claim his invention as he sees fit, it is recognized that the PTO must have some means for controlling such administrative matters as examiner caseloads and the amount of searching done per filing fee. In re Weber, 580 F.2d 455, 458 (C.C.P.A. 1978). United States Markush Practice in Flux April 3,

28 Brian K. Lathrop, Ph.D., Esq K Street, N.W. Washington, DC (202) (202) fax CALIFORNIA DELAWARE ILLINOIS NEW JERSEY NEW YORK PENNSYLVANIA WASHINGTON DC WISCONSIN 2012 Drinker Biddle & Reath LLP All rights reserved. A Delaware limited liability partnership United States Markush Practice in Flux April 3,

29 Markush Claims at the USPTO Robert D. Titus 03 April /3/2012

30 Disclaimer The opinions expressed in the following slides are solely those currently held by the presenter, and in no way represent the views of Eli Lilly and Company, any of its attorneys or agents, or of the AIPLA. 4/3/

31 Markush Claims and the USPTO The US Patent Office has struggled with Markush claims ever since the practice was adopted. Although early cases focused on whether such claims were definite or enabled, the issue of claim breadth and the corresponding searching and examination burden have emerged as most vexing to the USPTO. 4/3/

32 Markush Claims and the USPTO Indeed, the ill-fated rules package proposed by the USPTO in 2007 provided provisions for restricting a Markush claim that encompassed more than a single invention. (Examination of Patent Applications That Include Claims Containing Alternative Language, 72 Fed. Reg , (2007) (proposed Aug. 10, 2007)) Although the practice was prohibited long ago by its supervisory court (In re Weber, 198 USPQ 328 (CCPA 1978)), the USPTO continues to require restriction of Markush claims that allegedly lack unity of invention. 4/3/

33 Observations Regardless of actual breadth of the claim, the Examiner takes the position the genus is so vast that it cannot be searched (or even understood), and that it is impossible to enumerate the inventive groups. There are instances where there is apparently no actual analysis of the claims by the Examiner - rejections from different examiners have been received with boilerplate analysis containing identical typographical errors. 4/3/

34 Observations Petitions to overcome these restriction requirements are ineffective, as arguments that the restriction of a single claim is improper are typically ignored. Emphasis on the improper Markush rejection is not likely to be particularly satisfying to the patent bar because the USPTO takes a unique interpretation of unity of invention requirements, which are central to the USPTO s reasoning with respect to both the restriction of a single Markush claim and the improper Markush rejection. 4/3/

35 The Harnisch/Hozumi Divide Harnisch stands broadly for the proposition that unity of invention is satisfied if alternatives within a Markush expression are related. (In re Harnisch at 306) Specifically, when compounds within a Markush expression share a common utility and a single structural similarity the Markush expression represents a single invention. (In re Harnisch at 305) 4/3/

36 The Harnisch/Hozumi Divide In Hozumi, the BPAI correctly notes that all of the compounds in Harnisch had a common utility (dyestuffs), and that they all had a single structural similarity (coumarin compounds). (Ex parte Hozumi, 3 USPQ2d 1059 (BPAI 1984)) Interpreting Harnisch, the BPAI goes on to conclude, however, that all the claims had a functional utility related to a substantial, structural feature disclosed as being essential to that utility. (Hozumi at 1060, emphasis added) 4/3/

37 The Harnisch/Hozumi Divide This essential to utility requirement, however, finds no basis in Harnisch. It is important to note that an essential to utility requirement to establish unity of invention in a Markush claim in all instances is unique to the USPTO. (Compare: M.P.E.P. sections and 1850(III)(B); See also: WIPO s International Search Preliminary Examination Guidelines, paragraph 10.17(b) and paragraphs )) 4/3/

38 The Essential to Utility Problem The theory that a portion of a molecule is essential for its biological activity was discarded by medicinal chemists long ago, and is scientifically untenable. A molecule s biological activity is due to contributions from all of its structural components. (See: David A. Williams & Thomas L. Lemke, Foye s Principals of Medicinal Chemistry, 37-38, (5 th ed. 2002)) As such, arguing that a portion of a molecule is essential for the utility attributed to the molecule as a whole is nonsensical, and repugnant to the skilled artisan. 4/3/

39 The Essential to Utility Problem Indeed, cases considering the matter have concluded that in considering the propriety of a Markush grouping the compounds must be considered as a whole, and not broken down into elements or other components. (Harnisch at 305; M.P.E.P (h); In re Jones, 74 USPQ 149, 151 (CCPA 1947); and Ex parte Brouard, Leroy and Stiot, 201 USPQ 538, 540 (BPAI 1976). See also: In re Driscoll, 195 USPQ 434, 437 (CCPA 1977)) The difficulty in applying the essential to utility requirement in the small molecule context is illustrated by the following example. 4/3/

40 The Essential to Utility Problem US Application 10/535,002 contained the following Markush expression which was restricted by the USPTO for lack of unity of invention. Ar O S NH O O 1 R R 2 Ar represents 20 specific aryl moieties, 4 of which were substituted with an alkyl chain of varying lengths. All of the compounds were taught to have the same utility. 4/3/

41 The Essential to Utility Problem Unity of invention was established by the EPO as the PCT examining authority. The USPTO found that the claim lacked unity of invention because the compounds defined in the claims lack a significant structural element qualifying as the special technical feature defining a contribution over the art. 4/3/

42 The Essential to Utility Problem On petition, the Director articulated the following rules: to establish common activity, the activity must be provided by the core; the activity (of the core) must be known in the art; and the common core must be novel for utility. Requiring the core to be simultaneously novel and its activity known in the art are mutually exclusive. It would be impossible to establish unity of invention for any Markush claim, however modest, under these standards. Further, arguing a claim met these standards could be fatal to its patentability. 4/3/

43 The Essential to Utility Problem When applying these rules to the claims, the Director made the following remarkable statements: The benzoylsulfonamide structure is a structure common to all members of the Markush group... However, antitumor activity is not a known utility for benzoylsulfonamides. Therefore the benzoylsulfonamide structure does not provide Unity of Invention to the compounds of the Markush group because it does not possess the utility claimed. Even if the benzoylsulfonamide structure is considered to represent the major portion of the structure, it is so well known that it cannot form the special technical feature required that makes a contribution over the prior art. 4/3/

44 The Essential to Utility Problem Upon petition to the Office of PCT Legal Administration, The Legal Examiner acknowledged: a. Item (A) is satisfied, i.e., a common property or activity. b. The compounds share a common chemical structure, which occupies a large portion of the structure from B(1). 4/3/

45 The Essential to Utility Problem In spite of these findings, the Legal Examiner went on to argue: a.in the case of independent claims to A + X and A + Y, unity of invention is present a priori as A is common to both claims. However, if it can be established that A is known, there is a lack of unity a posteriori, since A (be it a single feature or a group of features) is not a technical feature that defines a contribution over the prior art. Note this standard applies to independent claims, not the single claim restricted in this case. 4/3/

46 The Essential to Utility Problem b. In the case where only a small portion of the structures is common to the compounds, the common portion must not only define a contribution over the art, but must also be essential to the common property or activity. The Examiner had found that the compounds share a common chemical structure, which occupies a large portion of the structure. This standard is inapplicable to the claim at bar. The restriction requirement was upheld because the core was known, it could therefore not define a contribution over the art and, as such, unity of invention was lacking. 4/3/

47 Current State of Affairs When a Markush claim is restricted or rejected as improper by the USPTO, argument is unlikely to overcome either in view of the USPTO s unity of invention formulation. Appellate review within the USPTO is unlikely to be helpful until the USPTO receives guidance from the courts. 4/3/

48 Drafting Strategies 1. Draft applications encompassing Markush claims with express support for subgeneric groupings based on specific structural families when possible. Provides clear written description should amendment of the claims be necessary in view of an improper Markush rejection. Could influence Examiner to restrict among groups defined in the specification. 4/3/

49 Drafting Strategies 2. Limit claim scope to a reasonable extrapolation from the actually exemplified embodiments. In the unpredictable arts, broad extrapolation beyond actual embodiments can make claims susceptible to enablement rejections with respect to both how to make and how to use the invention. The unpredictability of a given art can be critical to establishing the non-obviousness of the claimed invention. Vigorous arguments regarding predictability in the art to support expansive claim scope may undermine arguments supporting non-obviousness. The presentation of narrower claims has resulted in fewer rejections of or objections to claims and in more compact prosecution. 4/3/

50 Prosecution Strategies 1. Consider acquiescing to the restriction requirement. With the expansion of the application of obviousness-type double patenting doctrine, the 35 U.S.C. 121 safe harbor is becoming even more important. (See: Ex parte Lee, Appeal , Application 10/850,072 [Claims were held to be non-obvious, but obviousness-type double patenting rejection affirmed.]) There can be advantages (licensing/litigation) to important embodiments being in separate patents. It may not be possible to capture the full breadth of the original claim depending on the correlation between exemplification and claim scope. 4/3/

51 Prosecution Strategies 2. Propose alternate Markush groups. Look to specification for basis. Preserves 35 U.S.C. 121 Safe Harbor. 3. If possible, amend the claims and argue unity of invention of the new Markush language. Amendment requires basis in the specification, either a preferred subgroup for particular substituents or an alternative Markush expression for the invention. Inevitably results in relinquishing some claim scope. Likely will lose the 35 U.S.C. 121 Safe Harbor for excluded subject matter if it is pursued in a separate application. 4. Prosecute improper Markush rejection to final rejection, through Appeal and ultimately to Federal Circuit. Situation at USPTO unlikely to improve without supervision by the Court. 4/3/

52 Engage! 1. Engage the USPTO in discussions during rulemaking and comment periods with respect to Markush practice. 2. Engage in appropriate professional organizations to influence the bar and the USPTO. 3. Support harmonization between the USPTO and the PCT with respect to unity of invention and treatment of Markush claims. 4/3/

53 Closing Observation In spite of the recommendations with respect to the improper Markush rejection, the USPTO has not abandoned the idea of restricting a Markush claim. The BPAI recently required briefing on the question of whether a Markush claim could be restricted in Ex parte DeGrado (Appeal , Application 10/801,951) 4/3/