1001 Pennsylvania Avenue NW
Washington, DC 20004
3 December 1999
of Patents and Trademarks
Washington, DC 20231
RE: Comments on the Federal Register Notice Entitled "Changes to Implement the Patent Business Goals"
Dear Mr. Dickinson:
The following comments are made on behalf or our client, Genentech.
Thank you for the opportunity to comment on the proposed "Changes to Implement the Patent Business Goals; Proposed Rule, "64 FR 53795 (October 4, 1999). We appreciate your efforts to reduce costs and burdens on patent applicants and to increase the efficiency of the U.S. Patent and Trademark Office. In particular, we applaud your proposals to permit applicants to submit computer programs and sequence data in electronic form. (Changes to 37 C.F.R. §§ 1.96, 1.821, and 1.823) We believe that they will provide significant benefits to applicants and the Office. Also, we are encouraged by your proposals to simplify requests for small entity status and to clarify the procedures for the prosecution of patent and trademark applications by assignees.
There are some matters in the Notice, however, that we believe should be reconsidered and clarified. Also, some of the proposed rules should be changed, in our view. Our comments follow.
We recognize that this Notice does not contain rules to implement these Guidelines. The Notice, however, quotes and restates the Guidelines and announces the intention of the Office to differentiate between references discussed by the examiner and references cited by the applicant in an information disclosure statement. Consequently, we believe that it is appropriate to comment on the Guidelines and the Office's plans at this time.
In the Guidelines, the Commissioner states that the examiner is not responsible for reviewing all of the references cited in the disclosure statement (PTOL-1449) fully. Rather, the examiner is merely responsible for reviewing them in a cursory manner. According to the Commissioner, anyone reviewing the record must assume that references cited by the applicant only received this cursory review unless the examiner cites or discusses them specifically. Thus, a sharp distinction is made between references cited by the examiner that cannot form the basis of a reexamination request under Portola Packaging and those cited by the applicant that the Commissioner believes can be a basis for a reexamination request.
While these Guidelines may represent a well-intended attempt to ensure that reexamination procedures remain widely available, we believe upon closer analysis that they are counter-productive in the longer term. We believe that the inventors and the public would be better served if the examiners reviewed all of the references cited by the applicant fully and no distinction was made among references.
As a matter of public policy, we believe that the primary objective of the Office should be to issue patents that are enforceable and that are perceived to be enforceable. If applicants believe that a reference must be cited given their duty to disclose relevant information, the examiner should consider that reference thoroughly arid decide if it affects patentability, whether considered alone or considered with the other references under review. We believe that this would increase the "reliability" of patents - their enforceability and the perception of enforceability.
If examiners merely undertake a cursory review of references cited by the applicant, the public will perceive that the claimed invention may be unpatentable in light of the cited references. The reliability of the patent will decrease and its usefulness in securing venture capital, among other things, will decrease. As a practical matter, any presumption of validity is dramatically undercut.
Given that the Office is specifically attempting to make reexamination available in these instances, it appears that the Office is encouraging members of the public to use *reexamination to determine whether or not the claims are patentable in light of these references. Resolution of issues related to the applicability of references in a reexamination is far more expensive than a similar determination in the examination process.
To us, it would make far more sense for the examiner to review the cited references in the first instance and settle the issues of patentability during examination, as best as he or she can, rather than encouraging the adjudication of the impact of the cited references at a later date. To echo the words of one former Commissioner, the Office should issue patents that inventors can take to the bank, not the courthouse.
Given the opinion in Portola Packaging, some believe that practitioners could attempt to isolate the patent from validity challenges by citing a large number of references, and they characterize such an attempt as an "abuse". Frankly, we doubt that most practitioners will cite more references than are required under their duty to disclose. Even if they do, it should be relatively simple for examiners to examine frivolously cited references quickly and thoroughly. For those references that have some relevance, it is more efficient for all conce rn ed to evaluate them at this stage of the prosecution rather than in reexamination.
If there is a potential for abuse, it is by third parties who can force upon the patent own er a reexamination proceeding or a series of harassing reexamination proceedings, at least up to the point of the determination of a substantial new question of patentability. Specifically, a third party could base a reexamination request using references cited as relevant by the applicant but not fully considered by the examiner. It would difficult, if not impossible, to preclude such an abuse. If the examiner considered the references cited by the applicants fully, this abuse would not be possible.
Some believe that it would be useful to initiate reexamination based on references cited during examination in lieu of validity challenges in litigation, and believe that the opinion in Portola Packaging unduly limits the ability to do this. They may be correct.. The solution to this problem, however, is not the establishment of procedures that reduce the reliability of issued patents. Rather, the solution is to amend the reexamination statute to define more clearly which references may be used to initiate a reexamination proceeding.
There is another significant problem should the Office fail to consider all the references cited by the applicant thoroughly and draw a distinction among the references based on the level of its review. To ensure that the ensuing patent is reliable and to avoid unnecessary reexamination proceedings, prudent applicants will be forced to discuss the relevance of each cited reference to the claims in the application as suggested in the Guidelines.
The Office suggested that such descriptions should be mandatory in connection with changes to 37 C.F.R. §§ 1.97 and 1.98 (referred to as a requirement that "citations be uniquely described") proposed in the Advance Notice. See Changes to Implement the Patent Business Goals; Advance Notice of Proposed Rulemaking, 63 FR 53497 (October 5, 1998). The Office withdrew its suggestion, stating:
"The overwhelming majority of the comments expressed opposition to the unique description proposal of the Advance Notice. The Office has taken note of the large burden that would be imposed on applicants and attorneys by the description proposal of the Advance Notice, the potential for future adverse consequences stemming from doing the description or the choice not to describe, and the applicant's role reversal that would be imposed by the description proposal. Accordingly, . a decision has been made to not go forward with the unique description proposal at this time." [Emphasis added.]
See Changes to Implement the Patent Business Goals; Notice of Proposed Rulemaking, 64 FR 53772 at 53798 (October 4, 1999).
In essence, the Guidelines coupled with the proposal to draw a distinction between references present the same problems for applicants that the proposed rule on the unique description did. There is no reason to reach a different result in the case of the Guidelines than in the proposed rule. Consequently, the Guidelines should be rescinded and the proposal to draw differences between references should be abandoned. Any perceived problems with the opinion in Portola Packaging should be resolved through legislation.
2. Proposal to Amend 37 C.F.R. §1.98 To Require Submission of Cited References
The Office proposes to amend 37 C.F.R. §1.98(a)(2) to require the submission of copies of U.S. patent applications cited by the applicant during the prosecution of an application. The Office already requires the submission of copies of U.S. patents and foreign patent documents that are cited by the applicant.
In the discussion of the proposed amendment, the Office states that currently examiners must request copies of the cited applications and that the copies are made from the application file wrapper. It states that this copying could delay the prosecution of the application in which it is cited, could delay the prosecution of the cited application, and burdens examiners.
It was our understanding that all applications are electronically scanned upon receipt and an electronic copy of the application is created. This electronic copy is used to generate copies of the application as filed for customers. See Fee Codes 566 and 567 as well as 37 C.F.R. §1.19(b)(1).
If applications are scanned, none of the justifications for the proposal exist. Examiners should be able to access the application as filed electronically or obtain it without a burden. Delays in obtaining the copy should be minimal, so the prosecution of the application in question need not be delayed. As the file wrapper of the cited application is not needed, there would be no prosecution delay in that application. And as the specification as filed should fully disclose the invention, a copy of the application as filed should be sufficient for the examiner to determine its relevance. Only in rare cases should it be necessary to consult or duplicate the file wrapper.
We note that the Office currently charges $15.00 for a certified copy of an application as filed using the regular service. The cost to the examiner should not be this high because certification, printing, and mailing would not be necessary.
Also, we note that the Office states that including a copy of the cited application in the file wrapper would assist members of the public who inspect the file wrapper. We do not believe that this benefit justifies imposing the submission requirement on the applica n t. If the Office maintains the application data electronically now, it should be availabl e " to the public electronically. It is apparently currently available on paper for a fee. In future, it will be available as part of the electronic file wrapper of the cited application after publication in most cases.
As to U.S. patents, we understand that electronic copies of U.S. patents are readily available to examiners at their workstations and are available to the public via the Inte rn et without charge. It should not be burdensome for examiners to print them and we do not see any benef i t in requiring the submission of U.S. patents on paper. It is a burden on applicants and on the Office.
As to foreign patent documents, we understand that the Office acquired or will acquire electronic copies of patent documents originated by the European Patent Of fi ce and the Japanese Patent Office. Moreover, the Office is operating an "electronic pipeline" to these Offices with the intention of obtaining priority documents electronically. If our information is correct, there appears to be no reason why electronic copies of these documents cannot be obtained by the examiner from these sources in the near future if not available at present. This would not be a burden on the examiner and could significantly reduce processing burdens on the Office and the applicant.
Consequently, the proposal to require submission of copies of U.S. applications as filed should not be adopted if the applications are available within the Office electronically. The rule should be amended to delete the requirement to submit copies of U.S. patents. Also, the rule should be amended in a manner that relieves applicants of the burden of submitting foreign patent documents as these documents become available electronically to examiners within the Office.
The Office proposes to amend sections 1.111 and 1.115 to permit the Commissioner to refuse to enter a "second or subsequent supplemental reply" to an Office action and to refuse to enter preliminary amendments received after certain time periods, respectively. The Office states that the Commissioner would accept amendments when warranted, however. The purpose of these amendments is to eliminate the burdens on the Office caused by those who file multiple preliminary or supplemental amendments affecting a large number of claims, especially amendments filed shortly before an Office action is expected.
We do not believe that these changes would affect the prosecution of our applications significantly, as we do not routinely file these types of amendments. We remain conce rn ed in principle, however, about promulgating rules that impinge on the applicant's ability to file amendments promptly if these amendments reflect recently acquired Knowledge of the state of the art or that incorporate claims that better protect the applicant's invention. Furthermore, we remain unconvinced that there is a problem that justifies promulgating such rules.
The Office states that it is burdened by multiple supplemental amendments in app l ications, but then states that "The proposed change … will not affect the vast majority of supplemental replies." See 64 FR at 53801. If only a limited number of applications are affected, it is difficult to conclude that new, impinging rules are necessary. We assume the same is true for preliminary amendments.
In the Notice, the Office draws attention to the fact that many of the amendments that cause concern are filed at approximately the time an Office action is expected. We presume this means that the examiner in some applications must reformulate a draft action, thereby expending more time on the application. This may delay the mailing of the Office action, may increase the cycle time, and may possibly delay the grant of the patent. It also means that the examiner may have wasted resources examining matters that become irrelevant.
Given that the patent term is now measured from the filing date of the application and that most applications will be published, the Office need not be concerned about delays in mailing actions or in issuing patents caused by the applicant. These delays hurt the applicant, not the public. If the vast majority of these amendments are not affected by the proposal as stated, it is doubtful that cycle time would be significantly affected. Even if it were, however, the Office should consider changing its method of computing cycle time to place the responsibility for delays due to supplemental amendments with the applicant, not the examiner.
We recognize that some of those who commented on the proposals in the Advance Notice opposed the imposition of a fee for these amendments. We believe, however, that if there is credible evidence that multiple amendment filing is wasting a significant amount of the examiners' time, the Office should consider a fee to compensate the Office for the ' extra work it performs that is caused by the applicant for whatever reason.
We do not believe that applicants should delay filing amendments that are deemed necessary by the applicant to comply with the statute, or that barriers should be erected to preclude applicants from filing these amendments. These amendments generally will have to be considered at some point. As a result, they should be considered as promptly as possible, even if they create some additional work for the Office.
Consequently, we do not believe that the Office has proved that a significant problem exists, or that the proposed solution is the best one if the problem exists.
4. Proposals to Amend 37 C.F.R. §§1.52 And 1.121 To Provide For "Page Replacement" Amendments To Pat e nt Applications
These proposed sections provide for a new, mandatory technique for amending the specification and claims in an application. This technique is based on the replacement pages and copies of interlineated text, rather solely on instructions to amend the text as used traditionally in the Office.
The proposals represent an acceptable interim measure to improve the current poor quality of printed patent documents. Clearly, however, the requirement to submit a copy of the text showing the proposed amendments to the specification and claims as well as a clean copy of the proposed amendments is not ideal, and should not be necessary as demonstrated in practice under the Patent Cooperation Treaty. With electronic fil i ng, it would appear to us that there would be products available that permit the electronic filing of a text that shows proposed amendments but that can be used to create a "clean" version for printing and dissemination. Many word processing programs currently have this capability. We urge the Office to consider this proposal temporary and explore more sophisticated amendment techniques for the future.
Furthermore, we were unable to locate provisions that set forth the effective dates of the proposals. Given past practice, we expect that these sections would enter into force at some specified date after the publication of the final rules. If this were the case, the proposals on amendment practice would apply to all applications pending on that date, whether or not the application contained discrete sections or numbered paragraphs that could easily be amended. Consequently, applicants may have to submit substitute specifications even when only a small number of minor changes to the specification were proposed. For enterprises that have a large number of applications pending such as Genentech, this could cause a significant amount of additional work without significant benefits to the quality of the printed product.
Consequently, we recommend that the proposed amendment technique only apply to the applications filed on or after a specified date after publication. We recognize, however, that it may be in the applicant's best interest to use the new techniques in applications where lengthy amendments or a large number of amendments are proposed.