Biotechnology/Chemical/Pharmaceutical Customer Partnership Meeting

Wednesday, December 8, 2010[1]

Bruce Kisliuk

Assistant Deputy Commissioner for Patent Operations for Chemical Disciplines

PPH/Workshare

Overview of USPTO Work-Sharing

Work Sharing

Re-use the search and examination results done on an application or corresponding application to the maximum extent practicable in order to minimize duplication of work.

(see slide 5 - Cross filing Applications among IP5 Offices)

Foundations of Work-sharing form the Examiner and Applicant Perspective (see slide 4)

Work-sharing Initiatives

Patent Prosecution Highway (PPH)

SHARE-type initiatives:

USPTO-KIPO SHARE Pilot

USPTO & UK-IPO Action Plan for Re-use

JP-First

Trilateral FLASH Pilot

PCT Updates

PPH: Fast Track Examination of Applications

(See slides 6-8 for definition, purpose and benefits of PPH)

Current and Planned PPH Programs

Japan (JPO) PPH Pilot July 2006, Full Jan. 2008

United Kingdom PPH (UK IPO) Sept. 2007

Korea (KIPO) PPH Pilot Jan. 2008, Full Jan. 2009

Canada (CIPO) PPH Jan. 2008

Australia (IPAU) PPH April 2008

European Patent Office (EPO) PPH Sept. 2008

Denmark (DKPTO) PPH Nov. 2008

Germany (DPMA) PPH April 2009

Singapore (IPOS) PPH Feb. 2009

Finland (NBPR) PPH July 2009

Trilateral (EPO & JPO) PCT-PPH Jan. 2010

Korea (KIPO) PCT-PPH June 2010, only KIPO-to-US

Hungary (HPO) PPH July 2010

Russia (Rospatent) PPH & PCT-PPH Sept. 2010

Spain (SPTO) PPH & PCT-PPH Oct. 2010

Austria (APO) PPH & PCT-PPH Oct. 2010

China in discussions, Israel planned

See slides 10-14 on statistical data concerning PCT-PPH routing, USPTO PPH requests, and PPH benefits.

Promoting PPH

USPTO eliminated the PPH petition fee (effective May 25, 2010)

Robust outreach campaign launched

PPH informational video and brochure for external stakeholders (on USPTO website)

Communication plan targeting key meetings and audiences

Articles and blogs in popular IP publications

Question and feedback e-mail inbox established ()

FAQs posted on USPTO website

SHARE = Strategic Handling of Applications for Rapid Examination

Background

Intended to appropriately prioritize and balance workloads in order to maximize re-use of foreign search and examination results and minimize duplication of examination work done in other IP offices.

One important distinction of the SHARE-related projects relative to the PPH:

SHARE does not depend on an applicant’s request to reutilize work

SHARE operates independently of such requirements.

SHARE potential is not limited in the same way that PPH is limited by applicant requests.

See SHARE related projects (slide 17)

PCT Update:

PCT task force, formed in the fall of 2009

Mission

Ensure that USPTO provides world-class products and services under the PCT

Public Outreach

Public meeting held January 2010

Heard comments on how the USPTO could improve performance as RO, ISA, IPEA and DO/EO

Focus to date

Timeliness and quality of products and processing

See slides 20-21 for PCT timelines and quality

PCT Collaborative Search and Examination Pilot

Pilot project aimed at testing feasibility and potential of collaborative work between examiners of different Offices in the international phase.

Small scale pilot between EPO, KIPO and USPTO

Designed for six examiners per Office with each acting as:

The first examiner on two PCT applications in which their Office was selected as ISA.

Peer examiner on two PCT applications from each of the other Offices

Russia as ISA/IPEA (See slide 24)

PPH Resources (See slide 25)

Christian Chace

SPE, Art Unit 2187

Patents End-to-End: Update and Focus Session

Overall Goal:

USPTO’s Patent automation systems are a collection of systems (some dating back to the 1970s), that have evolved independently.

The USPTO ultimately seeks to develop a system architecture which will incorporate a re-design of the pre-examination, examination and post-examination processes.

Patents End-to-End Characteristics:

Deep engagement of the USPTO Director and Senior Advisors

Extensive stakeholder participation

Designed to accommodate ongoing change to business processes; business reengineering effort

XML-based infrastructure and software

Allows text-based searching of application contents

Recent upgrades to network bandwidth completed, further expansion planned

Current State vs. Future State of processes and systems (see slide 4)

Review of benefits and initiatives (see slides 5-8)

Planned Actions and Status

Initial set up: establish team, charter, timetables, and plans: COMPLETE

Collect data and ideas from multiple sources:

Internal open houses – COMPLETE. Ongoing data collection via .

External Outreach: Ad-hoc continuing through focus groups. Formal External Outreach Team formed and Plan nearing completion

Planned Actions and Status (continued)

Organize concepts (vetting, quick fixes, long-term):

In Progress – more than 12 working groups and 60 people currently working in “sprints”

Present and validate reengineered straw man:

Planned for January 2011

Collect feedback and adjust: Ongoing

Present recommendations for collaboration with IT team: Ongoing

Provide support for testing and prototyping: Q3,4 FY11; FY12

Provide assistance for development of training materials; FY12

Mercedes K. Meyer, Ph.D., Esq.

Drinker, Biddle & Reath, L.L.P.

Therasense

A comprehensive review concerning whether the outcome in Therasense, Inc. v. Becton, Dickinson & Co., 2010 WL 1655391 (Fed. Cir. April 26, 2010) (granting petition for rehearing en banc and vacating previous decision) (Therasense) will impact a practitioner’s duty of candor in prosecution

See slides 1-7 and 9 for background.

Therasense Prosecution Implications

Does an applicant have a duty to submit to the USPTO all arguments in replies made to a foreign patent office

OR

only those directly contradictory to arguments made before the USPTO?

Ways to distinguish THERASENSE?

Can the applicant distinguish the case over the facts of Therasense?

Can the practitioner track his prosecution arguments worldwide?

Does one only track contradictory arguments?

When is an argument abroad contradictory to an argument before the USPTO?

What does the applicant really have to submit from foreign applications?

•  e.g., references, search reports, declarations, and replies?

See slide11 for discussion of the implications of the Dayco, McKesson & Larson cases

See slides 13-28 concerning the implications in prosecution (regarding “When,” “Who,” “How,” and “What” to report)

See slides 29-39 concerning a discussion of what could be the probable results of all the case law, lack of guidance, and rampant inequitable conduct usage in litigation

See slides 40-41 concerning proposed legislation on supplemental examination

Kathleen Fonda,

Office of Patent Legal Administration

KSR Update

The 2010 KSR Guidelines Update

Effective as of its publication (September 1, 2010) in the Federal Register

(75 Fed. Reg. 53643).

Accessible, together with other post-KSR obviousness training materials for examiners, at http://www.uspto.gov/patents/law/exam/ksr_training_materials.jsp.

Summary of some, but not all, precedential Federal Circuit decisions concerning obviousness since KSR.

Provides examples of obvious and nonobvious claims.

Not a new USPTO policy with respect to obviousness.

Not a replacement for the 2007 KSR Guidelines.

Does not identify any new obviousness rationales.

Does not provide any per se rules. Each case must be decided on its own facts.

See slides 4-10 for structure of the 2010 KSR Guidelines and important points

See Slides 11-24 for summaries concerning combining prior art elements, substituting one known element for another and obvious to try

See slide 25 for contact information

NEXT MEETING: Wednesday, March, 2, 2010

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[1] Notes prepared by Paul D. Pyla, Esq. The content of these notes only represent the views of the preparer.