Feature Comment: Status of New Rules Affecting Continuation Practice, Claims Practice, and Information Disclosure Statement Practice

By James G. McEwen[1]


Under prior rules, an applicant was entitled to file as many continuation applications as needed to ensure that the invention was properly claimed and to prevent inadvertently narrow limitations from precluding literal infringement.  The only limitation on the number of continuations was generally set by matters of equity or where an applicant was not attempting to advance prosecution by amending the claims.  The applicant could also attempt to ensure such coverage using a single application which included as many claims as needed.  The limitation on the number of claims in a single application was set by the Examiner, who could issue a restriction if the number of claims being examined was deemed too burdensome for a single application. 

Likewise, applicants were strongly encouraged, through court decisions, to submit, in an Information Disclosure Statement, any information which could be deemed material.  Due to the influence of cases such as McKesson Information Solutions v. Bridge Medical, Inc., 487 F3d 897; 82 USPQ2d 1865 (Fed. Cir. 2007) and Nilssen, et al. v. Osram Sylvania, Inc., et al., 504 F.3d 1223; 84 USPQ2d 1811 (Fed. Cir. 2007), the standard for when documents and arguments need to be presented has been greatly expanded.  As such, practitioners have generally been highly inclusive in  determining what documents need to be submitted in order to ensure that, during enforcement proceedings, a court does not find the resulting patent unenforceable for failure to submit material prior art.

In an effort to reduce the number of outstanding applications, application pendency, and the claims for each application, the United States Patent and Trademark Office (USPTO) attempted to institute a new rule package to be effective on November 1, 2007.  As previously reported in Volume 3, Issue 3, of the Stein, McEwen & Bui Newsletter, the new rule package was designed to change existing patent prosecution strategies by effectively limiting the number of continuations and claims.   

Similarly, on July 10, 2006, the USPTO proposed changing the Information Disclosure Statement requirements in order to reduce the burden on the Examiner due to large submissions.  As previously reported in Volume 2, Issue 3 of the Stein, McEwen & Bui Newsletter, the USPTO proposed these rule changes as part of the USPTO’s Focus the Patent Process in the 21st Century plan, and are designed to “encourage patent applicants to provide the USPTO the most relevant information related to their inventions in the early stages of the review process.”  In order to achieve this goal, the USPTO is proposing applicants submit additional information about the submitted documents which varies dependent on the timing of the submission, as well as the number of submissions.

Status of Changes to Claim and Continuation Rules

In order to prevent the new continuation and claims rules from becoming effective, a suit was brought under the Administrative Procedures Act to enjoin their enactment.  The suit was brought in the Eastern District of Virginia first by an individual inventor, Triantafyllos Tafas.  This suit was later joined by Glaxo Smithkline.  On October 31, 2007, the District Court issued a preliminary injunction preventing the USPTO from implementing the rules as planned on November 1, 2007.  While not permanent, the preliminary injunction indicates that the rules may be reversed in at least certain areas.  However, since there is ongoing litigation over whether the preliminary injunction should be permanent and the scope of any such injunction, it remains unclear as to when such rules will be effective, and in what form.  For instance, it is conceivable that only certain rules will be enjoined, while others remain compliant with the Administrative Procedures Act.  As a result, any implementation will be subject to the District Court’s final decision on whether to permanently enjoin the rules, which should occur in the Spring of 2008.  As such, applicants cannot anticipate, with reasonable certainty, which portions of the rules will be implemented (if any) and when.

Status of Changes to Information Disclosure Statement Rules

Since the close of the comment period for the information disclosure statement rule changes, the rules have been submitted to the Office of Management and Budget (OMB) for final review.  This review is required by Executive Order 12866 for all new rules.  While an effort was made to have the rules revised or rejected while under review at the OMB, OMB approved the information disclosure statement rule changes on December 12, 2007.  As such, it is expected that the USPTO will issue the rules in final form in January of 2008.  However, the present form of these rules is not yet known, and certain changes are likely to have occurred since the close of the comment period.


As the final form of each rule change is uncertain, any suggestions in order to address the rule changes would be speculative at best.  However, it would seem advisable to assume, as a worst case scenario, that some form of the claims or continuation rule changes will be implemented.   Thus, it would be generally advisable to file any new continuations or applications with large numbers of claims prior to the final decision by the Eastern District of Virginia.  Moreover, in view of the impending changes to the rules for information disclosure statements and to the extent possible, any such information disclosure statements should be filed in an expedited fashion in case the final rules otherwise require the detailed explanations and updating originally proposed by the USPTO. The changes to the information disclosure statement, continuations and claims practices represent one of the largest changes to patent prosecution practice to occur in the past ten years.  These changes present specific challenges to the way in which patents have been prosecuted in the past, and the interlocking features of the potential rules make it especially challenging to formulate an effective strategy without substantial study of the policies and the language of the rules.  However, once such a review is done and after the final versions of the rules are implemented, it is apparent that applicants can still protect their inventions through aggressive combinations of restrictions, petitions, appeals, and possible accelerated examinations.  Thus, while the changes are substantial, applicants still have the ability to strategically protect their patentable inventions by adapting to the rule changes and taking advantage of the potential workarounds reported in previous articles of the Stein, McEwen & Bui Newsletter or to be developed.

[1] The opinions in this article do not represent the official positions of Stein McEwen, LLP.


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