Restriction practice update aipla biotechnology committee presentation march 17 2011
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Restriction Practice Update AIPLA Biotechnology Committee Presentation March 17, 2011. Office of Patent Legal Administration United States Patent and Trademark Office. Linda Therkorn [email protected]

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Restriction Practice Update AIPLA Biotechnology Committee Presentation March 17, 2011

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Restriction practice update aipla biotechnology committee presentation march 17 2011

Restriction Practice UpdateAIPLA Biotechnology Committee PresentationMarch 17, 2011

Office of Patent Legal Administration

United States Patent and Trademark Office

Linda Therkorn

[email protected]


Restriction practice update aipla biotechnology committee presentation march 17 2011

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

Overview

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First office action written restriction requirements

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)


First office action written restriction requirements1

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)


First office action written restriction requirements2

First Office Action Written Restriction Requirements

Comparison of Percent of Restriction Requirements - FY 2011


Tc 1600 restriction and unity of invention petitions

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

TC 1600 Restriction and Unity of Invention Petitions

84

75

2010


Restriction practice update aipla biotechnology committee presentation march 17 2011

TC 1600RestrictionandUnity of Invention Petitions


Restriction practice update aipla biotechnology committee presentation march 17 2011

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

“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


Restriction practice update aipla biotechnology committee presentation march 17 2011

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

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


Restriction practice update aipla biotechnology committee presentation march 17 2011

Exemplary Topics for Restriction Guidance/Training

  • Second, Subsequent and Mid-prosecution restrictions

  • Reconsideration of Restriction Requirements

  • Rejoinder Practice


Restriction practice update aipla biotechnology committee presentation march 17 2011

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

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Restriction practice update aipla biotechnology committee presentation march 17 2011

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

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Restriction practice update aipla biotechnology committee presentation march 17 2011

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.

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Restriction practice update aipla biotechnology committee presentation march 17 2011

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)

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Restriction practice update aipla biotechnology committee presentation march 17 2011

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.

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Restriction practice update aipla biotechnology committee presentation march 17 2011

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.

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Restriction practice update aipla biotechnology committee presentation march 17 2011

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.

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Restriction practice update aipla biotechnology committee presentation march 17 2011

Thank You

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