Restriction Practice Update AIPLA Biotechnology Committee Presentation March 17, 2011

04/22/2023 1

Restriction Practice Update

AIPLA Biotechnology Committee PresentationMarch 17, 2011

Office of Patent Legal AdministrationUnited States Patent and Trademark Office

Linda [email protected]

204/22/2023 2

Restriction-related Statistics

Request for Comments -- Restriction Practice Public comments USPTO response

Markush PracticeSupplementary §112 Examination Guidelines

Overview

3

First Office Action Written Restriction Requirements

Percent of US applications in which we require restriction (FY03 to FY11)

1600

1700

2100

2600

28003600

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

50.00%

55.00%

60.00%

65.00%

70.00%

2003 2004 2005 2006 2007 2008 2009 2010 2011Fiscal Year

% U

S Re

stri

ctio

n

1600 1700 2100 2600 2800 3600 3700

3700

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 371 applications in which we require a Lack of Unity (FY03 to FY11)

1600

1700

2100

2600

28003600

0.00%

5.00%

10.00%

15.00%

20.00%

25.00%

30.00%

35.00%

40.00%

45.00%

50.00%

55.00%

60.00%

65.00%

70.00%

75.00%

80.00%

2003 2004 2005 2006 2007 2008 2009 2010 2011Fiscal Year

% 3

71 R

estr

icti

on

1600 1700 2100 2600 2800 3600 3700

3700

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

2010

84

75

8

TC 1600 Restriction and Unity 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

• 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

Public Comments on Proposed Changes to Restriction Practice

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

• 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

USPTO Response to Public Comments

15

• 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

USPTO Response to Public Comments

16

• 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

Exemplary Topics for Restriction Guidance/Training

17

• Second, Subsequent and Mid-prosecution restrictions

• Reconsideration of Restriction Requirements

• Rejoinder Practice

Exemplary Topics for Restriction Guidance/Training

1804/22/2023 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 parte Markush, 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

1904/22/2023 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

20

04/22/2023 2004/22/2023 2004/22/2023 20

• 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.

35 U.S.C. § 112Supplementary Examination Guidelines

2104/22/2023 2104/22/2023 21

1. 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

2. “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)

Supplementary §112 Examination Guidelines

Markush Claims

2204/22/2023 2204/22/2023 22

• A claim contains an “improper Markush grouping” if:1. The species of the Markush group do not share a “single structural

similarity,”

2. 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.

Supplementary §112 Examination GuidelinesImproper Markush Grouping

2304/22/2023 2304/22/2023 23

• 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.

Supplementary §112 Examination GuidelinesImproper Markush Grouping (cont.)

2404/22/2023 2404/22/2023 24

• 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.

Supplementary §112 Examination Guidelines Compact Prosecution

25

Thank You

04/22/2023 25