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Genentech, Inc.

Moatz, Harry
From: jhasak@...
Sent: Tuesday, February 10, 2004 3:05 PM
To: ethicsrules comments
Subject: Comments on proposed USPTO OED/ethics rules

Dear Director Moatz:

Attached are the comments to the proposed OED-ethics rules from Genentech, Inc. Thank you very much for the opportunity to comment and for your consideration.

Best regards,
Janet Hasak

Genentech, Inc.

1 DNA Way
South San Francisco, CA 94080-4990

February 10, 2004

By electronic mail -

Mail Stop OED-Ethics Rules
Attention: Harry I. Moatz
OED Director, U.S. Patent and Trademark Office
P.O. Box 1450
Alexandria, Virginia 22313-1450

Re: Changes to Representation of Others Before the United States Patent and Trademark Office, 68 Fed. Reg. 69442 (December 12, 2003)

Dear Director Moatz:

Genentech, Inc. ("Genentech") appreciates the opportunity to comment on the proposed rule and practice changes described in Part 1 and Part 11, Subparts A-C in the Notice of proposed rulemaking. We also are grateful for the additional time granted to respond to Subpart D.

Genentech is a biotechnology company based in South San Francisco, California. Our mission is to be the leading biotechnology company, using human genetic information to discover, develop, manufacture and commercialize biotherapeutics that address significant unmet medical needs. Genentech commits itself to high standards of integrity in contributing to the best interests of patients, the medical profession, our employees and our communities, and to seeking significant return to our stockholders based on the continued pursuit of excellent science.

Patents are a fundamental aspect of our business. Since Genentech was founded more than 27 years ago, we have filed thousands of patent applications to protect our inventions, and we continue to file new applications on a regular basis. At any given time, we typically have hundreds of applications pending before the Office. As a Legal Department having more than 20

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patent professionals, we have a vested interest in holding our practitioners to the highest ethical standards.

Specific Comments

We offer the following comments with respect to the noted sections of proposed Section 11 of title 37 of the C.F.R.

§ 11.2(d)

We believe that the fee required under this section for a petition to review a decision of the OED Director should be refunded if a determination is made that the OED Director acted improperly.

§§ 11.8(d) and 11.11(b)

Proposed § 11.8(d) would require each registered patent practitioner to pay an annual fee. We appreciate that the USPTO must be provided sufficient funds to cover the costs of the disciplinary system for patent attorneys and agents and maintain the currency of the roster of registered practitioners. However, until the problem of USPTO fee diversion is solved, we do not believe that an annual fee should be charged. This proposal would create significant administrative burdens that would be underfunded and understaffed without clear assurances that the moneys received in supposed dedication to this cause would not be diverted to other areas of the government.

The consequences of failure to pay the annual fee proposed in § 11.8 pursuant to proposed § 11.11 (b) would be suspension. The suspended practitioner would not be able to practice before the USPTO and would be subject to investigation and discipline while suspended. These consequences would be unnecessarily severe for someone who inadvertently fails to pay the annual fee on time and does not timely receive the prescribed notices from the OED regarding payment of this fee. While automatically suspended, such a practitioner is likely to continue to prosecute applications until receiving actual notice. This would cause undue burdens for the OED and the practitioner, and furthermore would leave in question the status of applications that the practitioner processed while unknowingly suspended. The rule should be revised to address this scenario.

§ 11.10(a)

This section would only allow practitioners who are registered or are given limited recognition to prosecute patent applications of others before the Office. While "prosecution" is not defined anywhere in these proposed rules, proposed § 11.5(b) defines "practice before the Office" as including preparing and prosecuting any patent application, participating in drafting a patent application, and participating in drafting an amendment or reply to a communication from the USPTO. The ambiguity created by this rule would preclude administrative assistants or

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paralegals who work under the direction of a registered practitioner to assist, for example, in the preparation of a patent application or Office Action even under the direct supervision of a registered practitioner. We do not believe that the common practice of such assistants to work under the guidance of a practitioner should be discontinued.

§ 11.12

While in principle we support a requirement for continuing education as set forth in this section, we are concerned that such a program would create an administrative burden on the USPTO that would not be covered by sufficient guaranteed funds, since the current fees are subject to diversion.

If, however, such a program is adopted, we ask that the USPTO approve the programs already allowed for obtaining continuing legal education credit from any state bar, to avoid inefficiencies. This recommendation would still allow the USPTO to come up with its own educational program as another option for fulfilling those requirements.

Proposed § 11.12(a)(2) states that failure to consult the OG or the OED web site for announcements of eligible CLE programs and starting dates for completing each program will not excuse a practitioner from completing the mandatory continuing legal education program. Since such programs are the only ones to be offered in fulfillment of the requirements, this rule would require periodic reminders to review the OG and/or OED web sites, and appears to provide a harsh consequence for failure to check the OG or such web site at the appropriate time. It would be more helpful if the Office could provide periodic written notices by postal mail or email to serve as reminders to practitioners to check these sites if review thereof is imperative.

§ 11.13(g)(4)

This section would exclude certain entities as sponsors of continuing legal education, i.e., law firms, professional corporations and corporate law departments. The preclusion of this targeted group seems unduly restrictive, since such entities are often sponsors of CLE programs approved by many state bars. We see no reason for this seemingly arbitrary exclusion.

§ 11.20(a)(2)

This proposed rule allows the Director to impose a sanction by striking the filing of any document or dismissing the filing of an application with prejudice. The Office should clarify whether this striking is the same as expunging a document from the record of a USPTO file, with appropriate examples included of how this would be applied. Also, the meaning of the phrase "dismissing the filing of an application with prejudice" is unclear, and it is not altogether certain that the USPTO has the authority to make such a dismissal.

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§ 11.22(i)

The Office proposes that a respondent must respond to a complaint within a 60-day time period (an initial 30 days and one extension of no more than 30 days). This time period appears to be too restrictive, since preparing such response is a complex matter and a third party often must be contacted to obtain necessary facts in its sole possession. Hence, we suggest that the USPTO allow the OED Director discretion to grant additional extensions of time as necessary for a particular case.

§ 11.35(a)(1)

Since the sentence structure of this proposed rule in its outlined context does not make sense, we propose that at the end of this section, before the (i) and (ii) subsections, the phrase be added: "Such delivery is to:" This appears to be the meaning in view of the later subparts such as (a)(3) and (a)(4). We note that § 11.35(a)(2) appears to be missing.

§ 11.36(d)

We generally support this section that failure to file a timely answer to a disciplinary proceeding complaint will constitute an admission of the allegations in the complaint and may result in entry of default judgment. However, this seemingly absolute rule needs to be clarified to include an exception in the case where the complaint was not received and respondent had no opportunity to address the allegations in the complaint.


We appreciate the opportunity to offer comments on the proposed changes to the Office's procedures.

Sincerely yours,

Janet E. Hasak
Associate General Counsel - Patent Law

United States Patent and Trademark Office
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