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Brian Lathrop, Ph.D., Esq. brian.lathrop@dbr

Harnisch , Unity of Invention, and 76 Fed. Reg. 7166 AIPLA Biotechnology Committee Presentation March 17, 2011. Brian Lathrop, Ph.D., Esq. brian.lathrop@dbr.com. Disclaimer.

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Brian Lathrop, Ph.D., Esq. brian.lathrop@dbr

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  1. Harnisch, Unity of Invention, and 76 Fed. Reg. 7166AIPLA Biotechnology Committee PresentationMarch 17, 2011 Brian Lathrop, Ph.D., Esq.brian.lathrop@dbr.com

  2. Disclaimer • The views presented here are my own and should not necessarily be attributed to Drinker Biddle & Reath LLP, its clients, or AIPLA. 2

  3. 76 Fed. Reg. 7166 • On February 9, 2011, the USPTO issued Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications. • Among other things, the guidelines made subtle, but profound, changes to the way the USPTO handles generic claims recited species in the alternative (i.e., Markush claims). • Why should the biotech industry be happy about the Fed. Reg. notice? 3

  4. 2007: The Back Story • USPTO Commissioner: • “Absent evidence to the contrary, each such nucleotide sequence is presumed to represent an independent and distinct invention, subject to a restriction requirement . . . .” • Technology Center 1600 Director argued: • Markush claims were absorbing a disproportionate share of USPTO resources. • Certain claim formats were problematic. • Each independent and distinct alternative in a Markush claim should be filed in a separate application. 4

  5. Worst Case Scenario • Claim: A subcombination of any five probes selected from a group of 1800 probes having the common function of diagnosing a CD8+ DC tumor. • Each probe or small subcom-bination is an independent invention requiring a separate application! • The value of biotech patent assets was threatened. 5

  6. By 2009: The Perfect Storm • The invention could not be claimed: • The array must “comprise” the elected probe or subcombination, or • The array must “consist of” all the probes. • Claims were objected for containing non-elected species: • The Board could not review the objection. • Allowance could be delayed for years under Ex parte Quayle. 6

  7. The Perfect Storm (2) • Rejoinder was not allowed. • 1800 divisionals!? • Changing the elected species meant shifting inventions. • Notices of Non-Responsive Amendment under 37 C.F.R. § 1.145, which implicated PTA. • More wasted time to vacate by petition. 7

  8. The Perfect Storm in the Public Record • See USPTO Bulk Downloads: Patent IFW Petition Decisions: www.google.com/googlebooks/uspto-patents-petitions.html. • 65,000 unsearchable petition decisions. • But go to: 20100804IFWPetitionDecisions.csv. • Convert the csv file to an Excel spreadsheet and sort by number of pages (e.g., 4+), Tech Center (e.g., 1600), and class/subclass (e.g., 435/6, DNA arrays). • Find Decisions on public PAIR. • About 15% of sorted decisions concern restriction requirements. 8

  9. Sorted Results for DNA Arrays 9

  10. Weber • Many in the patent bar considered the result on slides 6-7 as contrary to the holding in In re Weber, 580 F.2d 455 (CCPA 1978): • As a general proposition, an applicant has a right [under 35 U.S.C. § 112. 2nd para.] to have each claim examined on the merits. . . . If, however, a single claim is required to be divided up and presented in several applications, that claim would never be considered on its merits. The totality of the resulting fragmentary claims would not necessarily be the equivalent of the original claim. 10

  11. Difficulty with Judicial Review • The district court reviews agency actions (e.g., a restriction requirement) under the Administrative Procedure Act: • The district court consults the MPEP (e.g., chapter 800) and case law (e.g., Weber) to determine whether the USPTO action was arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with the law. 5 U.S.C. § 706(a)(2). • But review requires a “final agency action,” and it is expensive and time consuming. 11

  12. Late 2009: • TC 1600 started to grant petitions. • Restrictions within a single claim were replaced with election of species under MPEP § 803.02. • Training Academy instituted new training. • Examiners started applying species elections without the need for petitions. • Was this a temporary fix or new USPTO policy? 12

  13. 2011: Fed. Reg. Notice • The Fed. Reg. notice makes species elections the official USPTO-wide policy: the perfect storm is over! • Significant improvements over current MPEP: • Improper Markush group rejection: The Board reviews failure to examine the full scope of the generic claim, even without a petition. • New standard: The USPTO no longer uses the “substantial feature essential for a common utility” standard. • Expedited prosecution: The Examiner may stop searching species only if a species is not allowable over the prior art or if the claim is an improper Markush group. 13

  14. “Improper Markush Group” • What keeps Applicants from claiming a group of unrelated inventions? • USPTO’s 2007 examples: • One claim directed to a protein, its encoding nucleic acids, an antibody against the protein, the protein ligand, a mimetic, etc. • A chemical genus directed to 2 x 1014 species. • In re Harnisch, 631 F.2d 716 (CCPA 1980) is the last precedential case on the subject. • A proper Markush claim must possess “unity of invention.” 14

  15. Harnisch • The claim: Coumarin compounds useful as dyestuffs: • Examiner: Serious search burden. • Solicitor’s Brief: The claim is an improper Markush group. 15

  16. “Recognized Class” (1) • Solicitor: Not a “recognized class”: • Widely different chemical and physical properties; • Lack of functional equivalence. • CCPA: It is a recognized class. • “We conclude that the board here was factually in error in not recognizing that all of appellant's claimed compounds are dyes.” • Members may pose a serious search burden and have widely different physical and chemical properties, and still be a “recognized class.” 16

  17. “Recognized Class” (2) • CCPA: The members do not need to be functionally equivalent, but they must have a common disclosed function: e.g., dyestuffs. • “Notwithstanding their various properties, the court found all of the [chemical compounds, which were growth-regulating compositions for plants, fungicides, and insecticides] included in the claims were plant growth stimulants, thus having a common function.” Citing In re Jones, 162 F.2d 479 (CCPA 1947). 17

  18. Recognized Classes in Biotechnology • “Dyes useful as dyestuffs” is a broad recognized class. • As broad as: • Probes useful for detecting the same disease (see ISPE Guidelines § 10.53); • Enzyme variants useful for catalyzing the same reaction; • Antibodies that bind the same epitope; • RNAi that target the same mRNA. 18

  19. Single Structural Similarity (1) • Board: • “The mere fact that there is a single structural similarity (i.e., the coumarin group) is not in itself sufficient reason to render all the embodiments functionally equivalent, particularly when the ultimate properties of the final products would not be expected to possess any recognized functional relationship.” 19

  20. Single Structural Similarity (2) • CCPA: A single structural similarity is sufficient: • “The board's reliance on its notion that some of the claimed compounds are ‘no more than intermediates’ overlooked the now admitted fact that they are dyes as well. Clearly, they are all coumarin compounds which the board admitted to be ‘a single structural similarity.’ We hold, therefore, that the claimed compounds all belong to a subgenus [i.e., “dyes”], as defined by appellant, which is not repugnant to scientific classification.” • “Sufficient” does not mean “necessary.” 20

  21. “And” v. “Or” • The holdings in Harnisch suggest that unity of invention exists if the members share a single structural similarity or if they are members of a recognized class. • Compare ISPE Guidelines § 10.17 (“or”). • But Markush rejections are questions of substance. The ISPE Guidelines are not binding on the USPTO when it determines questions of substance.

  22. The Concept of Unity of Invention (1) • Solicitor: unity of invention is about claiming multiple inventions in one claim: • “One aspect of the improper Markush group rejection not touched upon by the board or appellant needs to be presented to give the Court a full picture. . . . [It] has been a concern of the Commissioner that an applicant narrowing his claim in response to such a rejection not be met later with a double patenting rejection should he file a divisional application.” 22

  23. The Concept of Unity of Invention (2) • CCPA: • “It is with this unity of invention concept in mind that we approach the propriety of the appealed claims. . . . Reference to the widely-recognized concept of ‘unity of invention’ has been made in order to suggest an appropriate term to apply where unrelated inventions are involved—inventions which are truly independent and distinct. This case, we find, does not involve such inventions.” Emphasis in original.See also n.6. • USPTO cannot apply the “independent OR distinct” standard to Markush claims. 23

  24. “Independent” Inventions • “Independent” and “unrelated” mean something. • MPEP § 802.01 (2011): • “The term ‘independent’ (i.e., unrelated) means that there is no disclosed relationship between the two or more inventions claimed, that is, they are unconnected in • design [e.g., structure or method of manufacture], • operation [e.g., function or method of use], and • effect.” 24

  25. 2011 and Beyond • Biotech applicants should be able to claim: • A genus of related compounds having a common disclosed function, e.g., a DNA array, biomarkers; • Platform technologies; and • A lead compound and a genus of variants. (Read: a lead compound and its biosimilars.) 25

  26. Restriction Roundtable Discussion • The breadth of claims possibly having unity of invention raises policy issues regarding examiner search burden and allowance of species that were never searched. • The IP community and the USPTO can work together to address these policy issues.

  27. Conclusion • The biotech industry should be happy about the Fed. Reg. notice. • This is a fundamental change in U.S. chemical and biotech restriction policy, which at least will expedite prosecution and promote efficient judicial review. • So what has the EPO been doing recently? 27

  28. Brian K. Lathrop, Ph.D., Esq. 202-842-8862 brian.lathrop@dbr.com March 17, 2011 Thank You! 28

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