Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting

Wednesday, December 9, 2009[1]

Bruce Kisliuk

Assistant Deputy Commissioner of Patent Operations

USPTO Joint Labor and Management Count System Task Force

Count System Changes

Discussed Director’s Task Force Objectives - See slides for more detail

Provide Examiner incentives to address issues early in the examination process.

Emphasis on reaching out to applicants.

Reduce rework.

Emphasized objectives were to “Do no harm.”

Overall theme - better quality and decrease application pendency through “Compact Prosecution.”

Overview of proposed changes to count system

(See slides for comparison of current count system to new system)

New count system provides incentives to Examiners to follow compact prosecution principles and conduct early interviews with applicants so that hopefully RCE filings may become less necessary. Task force will measure effects of changes over fiscal year 2010.

Overall safety net is that that program has to work well.

Late January is actual implementation to the count time.

Program expires at the end of fiscal year 2010 (unless Agency and Union agree to continue), and task force will meet regularly to make adjustments if necessary.

May terminate program (as a safety net) if necessary (e.g., if quality drops).

Goal is more time overall for Examiners- more time for first action on the merits (FAOM). Focus quality control earlier in the process rather than later.

Count shift so that FAOMs get more credit.

Provide time to encourage Examiner-initiated interviews (including prep time and post interview documentation)

Examiner interviews –All Examiners have been trained on interview practice last year.

Changes in docket management policies – 1st in and 1st out with a 6 month pendency for FAOM, but goal is have this reduced.

RCE’s – On or after 11/15/09 the RCE will go on the Special New Docket. Before, it went on a 2 month response period.

If Application is ready for allowance –give the Examiner a call. Continuations are also on the special new docket. CIPs go on the regular docket.

Request for Continued Examination (RCE) credit diminished.

For RCEs filed on or after November 15, 2009 placed on the Examiner’s Special New Case docket (instead of an Examiner’s Amended Docket) to provide Examiners more docket management flexibility to handle RCEs.

USPTO will monitor the effects of RCE handling under the new production system, and in combination with the other USPTO initiatives will reevaluate the program and make any changes to ensure balances between the needs of applicants and Office operation (No indication if there will be transparency or if metrics will be transparent).

Regarding patentability determination errors, implement Examiner’s Performance Appraisal Plan (PAP) which includes elements covering quality, productivity, and timeliness.

Element in a Primary Examiner PAP is Patentability Determination.

Modified criteria so a single error would not trigger a performance evaluation problem.

Benefit to Examiner is to remove a potential barrier in the system and to encourage Examiners to work towards allowability when appropriate.

Task force will implement in fiscal year 2010 a modified Production Award Program to provide Examiners additional 5% incremental steps ranging from 110% to 135%.

Standardized Credit for Transferred or “Inherited” Amendments

Transferred cases – Examiners inheriting case will now get the counts.

Hoteling Program

There are 1200+ currently hoteling, one requirement for the Program is a rating of record of at least “Fully Successful.” Modified grace period is also implemented.

Telework at USPTO is growing and will play a larger role in the future (helps reduce USPTO costs).

Count Program Summary

Programs are in place for long-term pendency improvements, focusing on up-front quality work by increasing production credit for first action and more overall time that identifies allowable subject matter earlier in prosecution

Program changes reinforce compact prosecution by incentivizing decisions early in the process and supporting quality decision making.

First significant changes to the count system in more than 30 years, USPTO intends for this to be an iterative process and will closely monitor and evaluate system changes and are prepared to propose further adjustments as warranted.


Julie Burke

QAS, TC1600

Restriction Comparison: 35 USC 121 v. 371

Practice and Restriction Petition Report

Update for the fiscal year 2009

For TC 1600 (mailed):

33,191 first Office actions on the merits (includes telephonic restrictions)

11,871 restriction requirements

Approximately 75 restriction petitions

PCT application under 371-National stage filings:

29% of TC 1600 applications.

Resulted in 34% of the petitions.

78% of the Restriction Petitions were granted in full or in part.

34% of the petitions applications were filed under 35 USC § 371.

Average restriction petition turn around time about 100 days.

(Approximately 17 data slides from fiscal year 2004-2009)

2009 Common restriction concerns for U.S. and § 371 Applications (~30 slides):

Examiner Burke provides helpful information (including MPEP citations) regarding restriction practice.

Compounds and Compositions (See MPEP 806 and ISPE guidelines ex.15 & MPEP 1800),

Products and Processes (See MPEP 806.05(f) and (h) and PCT rule 13.2, ISPE guideline ex.1 - MPEP 1800),

Rejoinder (see MPEP 821.04 and 1893.05(d)),

Restriction after an Office action on the merits (generally improper, see MPEP 803: Restriction is permitted only when “serious burden on the Examiner”)

Election of Species permitted for new claims (see MPEP 808.01 and 821.03)

Reasons include Independence, Distinction and Burden - US applications (see MPEP 803). For § 371 Applications (see MPEP 1893.05(d))

Withdrawn via Election by Original Presentation

US applications and § 371 Applications (see MPEP 821.03, last paragraph)

Requirement to remove non-elected subject matter (see MPEP 803.02, 809, 821.04, 821.04(a))

Notice of Non-Compliant Amendments vs. Notice of Non-Responsive Amendments

(see for Notice of Non-Compliant Amendment MPEP 714)

(see for Notice a Non- Responsive Amendment MPEP 714.03)

Getting applications back on track

(see MPEP 707.02)

Jean Witz

QAS, TC1600

KSR Case Law Update

Based on USTO interpretation of current case law there are equal indications within the current cases that point to both non-obvious and obvious leanings by the courts post KSR.

USPTO guidance and highlights from the case law includes:

When inconsistencies occur between the specification and other evidence, the specification may be considered to be more probative.

Arguments that the prior art is above the level of ordinary skill may not be persuasive.

Scope of claim impacts a finding of obviousness.

Context of disclosures in a prior art document may suggest an obvious embodiment.

Recognition that stereoisomers may exhibit different properties may not be sufficient evidence of obviousness if prior art does not teach which results may ensue or how to separate any given enantiomer.

Structural relationships often provide the requisite motivation to modify known compounds to obtain new compounds

An obviousness rationale based on structural similarity may depend on a preliminary finding that one of ordinary skill in the art would have selected the prior art compound as a lead compound.

Regarding Obvious To Try:

An invention would not have been obvious to try when the inventor would have had to try all possibilities in a field unreduced by direction of the prior art (Bayer v. Barr at 1347)

When “what would have been “obvious to try” would have been to vary all parameters or try each of numerous possible choices until one possibly arrived at a successful result, where the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful,” an invention would not have been obvious. (Bayer v. Barr at 1347)

An invention is not obvious to try where vague prior art does not guide an inventor toward a particular solution (Bayer v. Barr at 1347)

A finding of obviousness would not obtain where “what was ‘obvious to try’ was to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it” (Bayer v. Barr at 1347)

Bennett Celsa

QAS, TC1600

Report on Compact Prosecution Workshop

Please refer to the slides.

Technical Center 1600, providing management-run, team approach training.

Teams include Restriction Practice, Examination Efficiency, First Action, Allowable Subject Matter, After-Final Practice, Interview Practice (USPTO-Wide) and Compact Prosecution (USPTO-Wide)).

Training will include art unit meetings, work-shops and voluntary lunchtime seminars.

For Compact Prosecution (USPTO-Wide), give Examiners the information and tools they need to reduce the amount of work and time that is required between the first action and final disposal (e.g., allowance, abandonment or appeal). See the Workshop slides: “Best Practices in Compact Prosecution Awareness.”

Marjorie Moran

SPE, Art Unit 1631

TC1600 Training: 35 U.S.C. § 101 in view of Bilski

Please refer to the slides.

NEXT MEETING: March, 2, 2010

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[1] Notes prepared by Paul D. Pyla, Esq. of Wenderoth, Lind & Ponack, LLP. The content of these notes do not represent the views of Wenderoth, Lind & Ponack, LLP.