Pfizer, Inc. v. Lee, No. 2015-1265 (Fed. Cir. 2016)

Written By: Justin Blaufeld


The Federal Circuit holds that a restriction requirement that fails to classify a few dependent claims is nevertheless sufficient to stop the clock under the Patent Term Guarantee Act.


A patent has a term of 20 years from its effective filing date.  Since undue delays at the PTO can often burn through a patent’s term, the Patent Term Guarantee Act (35 U.S.C. § 154(b)) provides for the restoration of patent term when the PTO misses certain deadlines.  Applicants may petition the Director to restore any days in excess of these deadlines after a patent application is deemed allowable.

In particular, the PTO must respond to a new application within 14 months of its filing date, and respond to a reply within 4 months after the date on which the reply was filed.  If the response is a rejection, it must comply with 35 U.S.C. § 132 (i.e., it must contain enough information to be “useful in judging of the propriety of continuing the prosecution of [the] application”).


On May 2, 2003, Patent Application No. 10/428,894 (“’894 application”) was filed.  On August 10, 2005, 404 days after the 14 month deadline, the PTO mailed a restriction requirement.  On February 6, 2006, the Patentee participated in a telephone interview with the Examiner and explained that the restriction requirement had omitted claims 75, 76, and 103-106 from its categorization of the various claims in the application. During the interview, the Examiner acknowledged that the restriction requirement was not complete; he agreed to withdraw it and issue a corrected restriction requirement. 


The PTO issued a corrected restriction requirement on February 23, 2006, 601 days after the July 2, 2004 deadline.  After a few rounds of substantive prosecution, the ’894 application eventually issued as U.S. Patent No. 8,153,768 (“’768 patent”) on April 10, 2012.  The PTO awarded the patentee with 404 days for its delay in sending out the first  restriction requirement (among other patent term awards for additional delays during prosecution).  The Patentee argues it is entitled to the additional 197 days that elapsed between the first restriction requirement and the mailing of the corrected restriction requirement.


Under section 132, the PTO does not have to explicitly preempt every possible response to a rejection. Instead, section 132 merely requires that an applicant at least be informed of the broad statutory basis for the rejection of his claims, so that he may determine what the issues are on which he can or should produce evidence.  Here, the Patentee argued that the PTO’s original restriction requirement failed to satisfy the notice requirement of Section 132 because it failed to classify six dependent claims into the examiner’s defined invention groups, and thus failed to place the applicants on notice of the restriction requirement as to those dependent claims.


The Federal Circuit held that the first restriction requirement, though defective, was sufficient under section 132 to stop the patent term clock.  “Although the examiner did not classify the omitted six dependent claims into one of the 21 defined invention groups, the examiner made clear on the face of the initial restriction requirement that he intended to account for all pending claims.” Pfizer v. Lee, No. 2015-1265 at 12 (Fed. Cir. 2016).  Moreover, “the examiner did nothing in the revised restriction requirement to modify the nature or description of the 21 distinct “inventions” already defined in the initial restriction requirement.”  Id. at 14.
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