PGPUB Comments - BIO
From: msharma@BIO.ORG Sent: Friday, May 26, 2000 1:38 PM To: Pre Grant Pub Subject: BIO comments The Honorable Q. Todd Dickinson Under Secretary of Intellectual Property and Director of the United States Patent and Trademark Office Box Comments - Patents Assistant Commissioner for Patents Washington, DC 20231 ATTENTION: Robert Bahr Comments on Proposed Changes to Implement 18-Month Publication of Patent Applications (65 FR 17946) Dear Director Dickinson: These comments are offered on behalf of the Biotechnology Industry Organization (BIO), a trade association representing over 900 entities doing business in the biotechnology sector. BIO members were strongly supportive of the legislative effort to require publication of patent applications. The final form of the legislation mandating publication falls somewhat short of our goals, but we believe that practices under the new system will meet the expectations of our industry. We are generally supportive of the proposed system by which the PTO has proposed to implement 18-month publication. In particular, we support the decision of the PTO to publish applications electronically, rather than using a paper-based model integrated into the Official Gazette cycle form. We are also supportive of developments that will make feasible electronic filing of patent applications and to use these systems to modernize the means by which we can communicate and do business with the PTO. Our suggestions in respect of the system and the proposed rule package can be divided into three general categories. 1. Comments on Proposed Operating Principles for the Publication System BIO Members recognize the need for fixed deadlines for application requirements as a condition for operation of a publication system. The deadlines articulated in the guidelines (other than in respect of publication of redacted copies of applications upon which we express no opinion) are acceptable in principle to our industry. These deadlines will require that elements of a patent application that are needed to put it in condition for publication be received prior to the date that is the later of sixteen months from the effective filing date or four months after the actual filing date. Notwithstanding our support for these deadlines, we believe it is necessary for certain issues to be addressed. (a) Sequence listing formalities The issues regarding sequence listing deposits are not adequately addressed in the notice or the rules. We believe the PTO should make absolutely clear the following issues regarding sequence listing deposits: - the latest date upon which a sequence listing deposit must be submitted or perfected to avoid delay of transfer of the application to the examining corps; - whether applications containing listings that have not complied with the formality requirements associated with those deposits will be forwarded to the examiner for substantive examination; - whether the sequence listing deposit will be subjected to the new standards and policies on compliance to be applied to drawings (i.e., no flexibility on non-compliance), and if so, what changes will be implemented to reduce the complications associated with use of the sequence listing authoring and submission software; and - precisely how parties are to make references to sequences previously deposited. Explicit and clear requirements relating to deposits of sequence information is critical to the ability of our members to comply with the new publication system. We urge the PTO to take note of the past difficulties that have been associated with the use of the authoring software and compliance by patent applications with this system in developing its position on such submissions. (b) Access to file wrappers following publication The PTO has indicated that it intends to provide full access to patent application file wrappers following publication of the application. While this approach seems to endorse a model of openness and maximum public access, BIO members are concerned that it cannot be implemented by the PTO in way that will not prove extremely disruptive to the examination process. The experience of our Members with obtaining copies of file wrappers from the PTO is unfortunately very negative. All too frequently, file wrappers are lost, misplaced and often the contents of file wrappers are compromised (i.e., items lost, mutilated or put out of order). A system that presumes that file wrappers will not be lost and will not have their integrity compromised, unfortunately, is not one that the PTO seems capable of establishing. We accordingly urge the PTO to defer providing access to the public to file wrappers until the date when it is able to produce copies of such file wrapper histories from a digital, rather than physical, copy of the documents that make up the file wrapper. Any system that would require additional and unnecessary handling of the file wrappers by PTO staff pursuant to a copy of file request is likely to significantly increase the likelihood of loss or corruption of the file wrapper contents. If the PTO can extend the document capture system used for applications that are to be filed on paper or can implement a new system that would allow copies of the file wrapper to be produced while it is still pending, our concerns about public access to the contents of the file wrapper while applications are still pending will be mitigated. Until the PTO can provide copies from digital records rather than physical paper records, we urge that the policy on access be reconsidered and no access provided to the public. The risks associated with corruption and loss of physical contents of the file wrappers while applications are still pending are simply too great to be ignored. (c) Use of title of invention for correlation of EFS filings The PTO has indicated that it intends to rigorously enforce title of invention requirements to ensure that it can implement its Electronic Filing System (EFS) system. In the description of the EFS system, the PTO has indicated in particular that it will use the title of the application to correlate a later-filed substitute specification to an original file record associated with the application. We are puzzled by this decision to use the title of the invention as the key for data to be handled and processed by the PTO's EFS system in view of the fact that (a) titles are not usually unique identifiers of applications and (b) each patent application does have a unique identifier (i.e., the application serial number) that is the logical reference point for use in database systems like these. We encourage the PTO to use the serial number rather than the title for data handling steps such as these. 2. Third party prior art submission procedure The PTO is proposing to establish a procedure by which third parties may, within two months following the publication date, submit prior art that will be entered into the file wrapper of pending applications. Certain points associated with this process should be reconsidered and revised to ensure that it does not prove unworkable or become a means by which third parties can harass or disrupt the examination process. In this regard, BIO recommends the following changes be made: - The PTO is proposing to require that the information provided by a third party be served on the patent applicant. The rule to implement this requirement, however, does not specify whether it is the party submitting the information or the PTO that must serve the information on the patent applicant. We believe the only acceptable approach would be for the party submitting the information to provide evidence that it has served the information on the patent application. - The PTO must implement this procedure in a way that forecloses the possibility of third parties abusing this process to delay or harass patent applicants. One step that could be implemented to do this would be for the PTO to require that the party submitting the information to declare whether they are submitting the information pursuant to an agency relationship, and if so, to identify the real party in interest (i.e., the principal) that is making the submission. Requiring parties to properly identify themselves will help minimize the frequency of situations where third parties submit information to harass or impede the examination process. - The PTO should adopt an approach that will not allow third parties to file large amounts of irrelevant or redundant prior art. The current approach of allowing twenty references per submission will allow a tremendous volume of information to come into the file wrapper that is likely to be irrelevant to examination. The twenty-reference standard will also encourage parties to not rigorously consider and forward the most relevant prior art. To prevent this practice from evolving into an unmanageable process, we encourage the PTO to limit the total number per filing to no more than five per submission. We also suggest that the PTO screen the submitted prior art to eliminate references provided in a submission that have already been cited in the application. 3. Other Issues A number of other specific issues were identified that merit comment. - The law permits third parties to expressly abandon an application to prevent its publication. The PTO has properly indicated that its ability to suppress publication depends on when it receives notice of an express abandonment. Recognizing the immense volume of paper coming into the PTO each day, we recommend that the PTO set up a special box for notifying the PTO of an express abandonment that was made to avoid publication. This will segregate mail coming in to the PTO to allow last minute abandonments to achieve their goal of suppressing publication. - Proposed rule 1.215(b) will allow patent applicants to identify their ownership interest on the face of the published patent application. We encourage the PTO to provide a form or sample format for this separate paper that is to be included with applications to avoid confusion as to the requirements for this procedure. - The transition to a publication system will result in a number of situations later this year where applications having an effective filing date more than 18 months earlier than November 29, 2000 will be subjected to an immediate requirement for publication under the law (i.e., where the application is filed after November 29, 2000, and claims priority to an application filed earlier than 18 months before this date). Given the strict posture the PTO is taking with regard to compliance with formalities, and in view of the potential loss of patent term due to non-compliance with formalities, we believe it is essential for the PTO to set up a transitional procedure for these applications. One approach could be to set a specified period for compliance with formalities for applications filed having this profile for a set period of time, where compliance within a four to five month period will not be treated as non-diligent prosecution. Without a transitional period, the PTO's approach will unfairly punish applicants just as the new system is being implemented. In conclusion, we believe the rule package and the general operating model being adopted by the PTO is sound, and should be improved as recommended above. We look forward to working with you to build a viable and user-friendly system. Sincerely, L. Val Giddings, PhD. Vice President for Food and Agriculture
