Restriction Practice Update AIPLA Biotechnology Committee Presentation March 17, 2011

1. Restriction Practice UpdateAIPLA Biotechnology Committee PresentationMarch 17, 2011 Office of Patent Legal Administration United States Patent and Trademark Office Linda Therkorn linda.therkorn@uspto.gov

2. Restriction-related Statistics Request for Comments -- Restriction Practice Public commentsUSPTO responseMarkush PracticeSupplementary §112 Examination Guidelines Overview 2

3. First Office Action Written Restriction Requirements Percent of applications filed under 35 U.S.C. 111(a) which received an initial written restriction requirement over all first actions (restriction and actions on the merits)

4. First Office Action Written Restriction Requirements Percent of applications entering the national stage under 35 U.S.C. 371 that received an initial written determination of lack of unity over all first actions (unity determinations and actions on the merits)

5. First Office Action Written Restriction Requirements Comparison of Percent of Restriction Requirements - FY 2011

6. TC 1600 Restriction and Unity of Invention Petitions In FY09, TC1600 mailed 33,191 first Office actions on the merits mailed 11,871 written restriction requirements received about 75 restriction petitions In FY09, national stage filings of a PCT application under 371 account for 23% of TC1600 applications yet result in 34% of the petitions In FY09 78% of the Restriction Petitions were granted in full or in part

7. TC 1600 Restriction and Unity of Invention Petitions 84 75 2010

8. TC 1600RestrictionandUnity of Invention Petitions

9. In June 2010, the Office asked the public for feedback regarding restriction practice. See Request for Comments on Proposed Changes to Restriction Practice in Patent Applications, 75 Fed. Reg. 113, 33584-587 (June, 14, 2010) http://www.uspto.gov/patents/law/notices/75fr33584.pdf Request for Comments on Proposed Changes to Restriction Practice

10. Q1. What should be included in an Office action that sets forth a restriction requirement? Q2. What practice changes will result in more effective ways to seek higher-level review of restriction requirements? Q3. How could the USPTO clarify requirements for restriction between related product/process inventions not otherwise provided for? Request for Comments on Proposed Changes to Restriction Practice

11. Q4. How could the Office modify Markush practice? Q5. How could the Office improve rejoinder practice? Q6. What other areas of restriction practice can the Office improve and how? Request for Comments on Proposed Changes to Restriction Practice

12. Public Comments on Proposed Changes to Restriction Practice • The Office received twenty seven comments from a variety of IP organizations, companies, law firms, and individuals. • http://www.uspto.gov/patents/law/comments/restriction.jsp

13. “In the view of many practitioners, restriction practice is out of control, and lacking in consistency, conformance to published guidance in the Manual of Patent Examining Procedure (MPEP) and appropriate management oversight.” See http://www.uspto.gov/patents/law/comments/aipla13aug2010.pdf “Unwarranted restriction requirements result in prosecution delays, excessive claim fees and costs, and superfluous filing of multiple divisional patents further increasing the backlog.” See, http://www.uspto.gov/patents/law/comments/ipo13aug2010.pdf Public Comments on Proposed Changes to Restriction Practice

14. USPTO Response to Public Comments • Restriction team formed • Investigating options to improve current restriction practice • Given mandate to investigate whether/how best to transition to a unity of invention standard

15. USPTO Response to Public Comments • Office is looking to • Provide guidance on the procedural aspects of restriction and rejoinder practice • Improve training • Revise form paragraphs • Improve review of restriction requirements • Limit late prosecution restriction requirements

16. Exemplary Topics for Restriction Guidance/Training • Criteria for restriction • 35 USC 111(a) applications • reasons for patentable distinctness (independent/distinct) and • explanation of burden if restriction were not required • 371 applications • reasons for finding lack of unity • Examples of unwarranted restriction requirements

17. Exemplary Topics for Restriction Guidance/Training • Second, Subsequent and Mid-prosecution restrictions • Reconsideration of Restriction Requirements • Rejoinder Practice

18. Attempts to rein in administrative problems arising from Markush claims have been unsuccessful. 35 U.S.C. 112, ¶ 2 (alternatives per se indefinite) Ex parteMarkush, 1925 C.D. 126 (Comm'r Pat. 1925) Equivalence of members of a Markush group for purposes of obviousness determinations In re Ruff, 256 F.2d 590, 118 USPQ 340 (CCPA 1958) 35 U.S.C. 121 (accompanied by a restriction requirement and withdrawal of the claim) In re Weber, 580 F.2d 455, 198 USPQ 328 (CCPA 1978) Markush Claims 18

19. In 2007, USPTO proposed rules to address treatment of Markush claims in a manner somewhat analogous to PCT-style unity of invention. See Examination of Patent Applications That Include Claims Containing Alternative Language, 72 Fed Reg 44992 (Aug. 2007) http://www.uspto.gov/web/offices/com/sol/notices/72fr44992.pdf Public comments submitted in response to the 2007 proposed rulemaking were generally not favorable. Markush Claims 19

20. 35 U.S.C. § 112 Supplementary Examination Guidelines • The Supplementary §112 Examination Guidelines were published in the Federal Register on February 9, 2011. • See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. § 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), available at http://www.uspto.gov/patents/law/notices/2011.jsp. • The corresponding Memorandum to the Examining Corps is available at http://www.uspto.gov/patents/law/exam/memoranda.jsp. 3/17/2011 3/17/2011 20 20 20

21. Supplementary §112Examination Guidelines Markush Claims • Indefiniteness Rejection under §112, ¶2 • Proper to reject a claim with a Markush group as indefinite when the metes and bounds of the invention would be unclear to persons skilled in the art • “Improper Markush Grouping” Rejection • A Markush claim may be rejected under the judicially approved “improper Markush grouping” doctrine when the claim contains an improper grouping of alternatively useable species. In re Harnisch, 631 F.2d 716, 206 USPQ 300 (CCPA 1980) 3/17/2011 21 21

22. Supplementary §112Examination Guidelines Improper Markush Grouping • A claim contains an “improper Markush grouping” if: • The species of the Markush group do not share a “single structural similarity,” • The species do not share a common use, • Meaning they are not disclosed in the specification or known in the art to be functionally equivalent. • If 1 or 2 apply, then an “improper Markush grouping” rejection should be made. 3/17/2011 22 22

23. Supplementary §112Examination Guidelines Improper Markush Grouping(cont.) • No court has addressed an improper Markush rejection since Harnisch, so the doctrine has been dormant for the past 30 years. • In time, the Board and Federal Circuit will develop a body of case law to guide examiners in rejecting claims that include improper Markush groups, just as it has for other patentability doctrines. 3/17/2011 23 23

24. Supplementary §112Examination Guidelines Compact Prosecution • Clearly articulate all appropriate rejections early in the prosecution. • Review each claim for compliance with every statutory requirement for patentability and reject each claim on all reasonable grounds to avoid piecemeal examination. • When making both a §112, ¶2 rejection and a rejection over prior art, state on the record how the claim term or phrase that is indefinite is being interpreted. 3/17/2011 24 24

25. Thank You 25