Source: http://yarbroughlaw.com/PA%20IP%20Forum/PA%20IP%20Forum%20advocacy/Claim%20rulemaking/comments%20to%20claim.htm
Timestamp: 2019-04-24 21:59:33+00:00

Document:
In the above Federal Register Notice dated January 3, 2006, the U.S. Patent and Trademark Office requested public comment regarding the above Notice of Proposed Rulemaking. This letter presents the comments of the Pennsylvania Intellectual Property Forum ("Pennsylvania IP Forum"). The Pennsylvania IP Forum is an organization of patent practitioners and intellectual property attorneys located principally in Southeastern Pennsylvania. While some of us represent large entities, all of us represent individual inventors and small entities. Large entities already have significant advocates in Washington. Our purpose in making these comments is to provide a voice to individual inventors and small entities that otherwise would not be heard.
The Pennsylvania IP Forum appreciates the opportunity to offer comments on the rule and practice changes proposed by the Office. We believe that the proposed changes would adversely affect the patent prosecution process in terms of time and cost, particularly for small business. We are concerned by the continuing shift in burden during prosecution from the Office to applicants having limited resources. We are specifically concerned that the proposed rules will have unintended consequences to small business.
The value of small business entities to the US economy cannot be overstated. The publication entitled “A Guide for Governmental Agencies: How to Comply with the Regulatory Flexibility Act” (“RFA Guide”), promulgated by the Small Business Administration, sets forth Federal agency data on small businesses. In its description of how important small businesses are to the US economy, the RFA Guide indicates that small businesses represent more than 99.7 percent of all employers. Moreover, on p.99 of the RFA Guide, the research set forth indicates that "small firms produce 13 to 14 times more patents per employee than large patenting firms. Those patents are twice as likely as large firm patents to be among the one (1) percent most cited." It is thus a matter of public record and, indeed, a finding of the Federal government, that the patent activities of our country’s small business entities are crucial to the U.S. economy.
The Pennsylvania IP Forum agrees with and adopts as its own the comments of Robert A. Vanderhye. Mr. Vanderhye’s comments are incorporated herein by reference and a copy of those comments is enclosed as Attachment 1.
The PTO has failed to adequately consider the effect of the above pending rulemaking on the small business community as required by the Regulatory Flexibility Act, 5 U.S.C. §§601-612 (hereinafter “RFA”). The rulemaking package in question is crucial to small businesses and a full regulatory flexibility analysis is required. We request that you direct the PTO staff to fully comply with the requirements of the RFA, and that the rulemaking package be republished for public comment after that compliance and prior to final promulgation. We believe that if the PTO fails to perform a full regulatory analysis in compliance with the terms of the RFA, the rulemaking package will be invalid and vulnerable to challenge under 5 U.S.C. §611(a)(4).
The Small Business Administration (“SBA”) has determined that the PTO should conduct a full RFA analysis of the pending rulemaking. See enclosed Attachment 2, a letter of April 27, 2006 to Undersecretary Jon W. Dudas of the PTO from Thomas M. Sullivan, Chief Counsel for Advocacy and Carrol L. Barnes, Assistant Chief Counsel for Advocacy of the SBA.
When an agency issues a rulemaking proposal, the RFA requires the agency to “prepare and make available for public comment an initial regulatory flexibility analysis (IRFA)” which will “describe the impact of the proposed rule on small entities.” 5 U.S.C. §603(a); Northwest Mining Association v. Babbitt, 5 F. Supp.2d 9 (D.D.C. 1998). Before a proposed regulation is published in the Federal Register, the RFA requires the promulgating agency to identify the entities to be regulated by size and number, estimate the economic impact by size category and determine which size categories will be impacted. The promulgating agency must then ask the following question, “Will the rule changes have a significant economic impact on a substantial number of small entities?” 5 U.S.C. §605(b). If the answer to that query is positive, an initial regulatory flexibility analysis must be performed. If the answer to this question is negative, the head of the agency may then certify that the rule will not have a significant impact. Such a certification must include a statement providing the factual basis for this determination.
The Office of Advocacy of the Small Business Administration is required by Section 612 of the RFA to monitor agency compliance and disseminated the RFA Guide to inform agency action. The RFA Guide provides that the statement accompanying a certification of no impact, at a minimum, must include (a) a description of the affected entities, and (b) the facts that clearly justify the certification that there will be no significant impact. The agency’s reasoning and assumptions underlying the certification must be explicit in order to obtain public comment and thus, receive information that would be used to re-evaluate the certification. See Guide, at pp. 8-9. The decision to certify must be based upon a sound threshold analysis to support a finding of no significant impact and the record an agency builds to support a decision to certify is subject to judicial review under 5 U.S.C. §611(a).
c. The PTO certifications do not meet the RFA requirements because proper credible facts to support the certifications are lacking.
The PTO failed to provide facts that clearly justify the certification of no significant impact. The proposed rule change seeks to revise the rules of practice relating to examination of claims to an initial examination of “representative” claims, which would include all independent claims and those dependent claims which are expressly designated by the applicant for initial examination. If greater than 10 claims are submitted for initial examination the proposed rule change will require, among other things, an examination support document that “covers” each independent and dependent claim designated for initial examination. This burden-shifting tactic creates a substantial burden, both financially and in terms of time, upon the applicant and will have a significant economic impact especially upon those applicants who can least afford it- small business entities as well as individual inventors.
In support of the statement that “(t)he changes proposed in this notice will not affect a substantial number of small entities”, the PTO proposes several narrow analyses which either compare “apples to oranges” or contain antiquated information for which no support can be obtained. The PTO states that only 1.3 percent of small entity non-provisional applications filed since January 1, 2005, contain more than ten independent claims. 71 Fed. Reg. 66. However, the proposed rule provides that an examination support document MUST be submitted if more than ten claims total are designated for initial examination. The PTO assertion does not support the conclusion for which it is cited.
The PTO states that there are no fees associated with the proposed rule change and then indicates that, according to an economic survey conducted by the AIPLA and reported in 2003, a “patent novelty search, analysis and opinion was $2,500.00.” The PTO assertion is a non sequitur. There is no indication that a “patent novelty search, analysis and opinion” would satisfy the requirements of proposed §1.261. There is also no indication that a showing necessary to satisfy proposed §1.261 could be purchased for $2,500.00. The PTO assertion does not support the conclusion for which it is cited.
It is not only the realistic cost of preparing such an examination support document which will be a burden to small entities, but also the time spent doing so. For a small entity, time is a valuable resource. The time spent preparing such a document could be spent on operating its business or furthering the innovative process. The magnitude of the loss on a substantial number of small entities could be very significant indeed.
d. The proposed rulemaking does not comply with the RFA because the PTO does not evaluate alternatives.
Under 5 U.S.C. §603(c), the keystone of an initial regulatory flexibility analysis is the description of any significant alternatives to the proposed rule that accomplish the stated objectives and that minimize the rule’s economic impact on small entities. There are no viable alternatives suggested within this rulemaking to provide regulatory relief to small entities as required.
There are several alternatives that the PTO should evaluate and that would efficiently and effectively achieve the PTO’s stated goals without unduly burdening small entities or stifling innovation. The first alternative is to exempt small entities from the regulation. Since, as the PTO alleges, such a small percentage of applications by small entity applicants will be affected, one manner in which to avoid the further scrutiny under the RFA is to exempt small entity applicants from compliance.
Another alternative not evaluated by the PTO is to limit the applicability of the proposed change to patent applications containing ten independent claims, since only 1.3 percent of small entity non-provisional applications would be affected. Both of these suggestions should be considered as alternatives to reduce the impact of the proposed rule changes on small entities.
e. The PTO should conduct the required analyses of impact on small business and republish the proposed regulations for comment.
In making public comment to the proposed rulemaking, the public is entitled to review any and all credible information the PTO relied upon in making its decision to certify that the proposed rule changes will not have a significant effect under the RFA. The PTO has presented no such credible information in the proposed rulemaking. The PTO also has provided us with no such credible information in response to a Freedom of Information Act request from one of our members. We are left to infer that no such credible information exists.
We believe that the proposed rule change will have a significant impact on a substantial number of small entities both in terms of out of pocket costs as well as in valuable time. The PTO should perform a full regulatory flexibility analysis and should republish for public comment the proposed regulation, including the regulatory flexibility analysis. If the PTO does not comply with these requirements of the RFA, the regulation packages will not be effectively promulgated and will be vulnerable to challenge under 5 U.S.C. §611.
The members of the Pennsylvania IP Forum appreciate the opportunity to comment on the proposed rules and would be pleased to further assist the Office in any manner necessary to consideration of the issues discussed above.

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