IP Law Bulletin

In general, the patent term for a United States patent extends 20 years from the earliest U.S. filing date from which the patent application claims priority. Because the patent term is calculated from the filing date, prosecution delays at the United States Patent and Trademark Office (USPTO) will shorten patent term. Often, due to the patent examination backlog at the USPTO, prosecution delays are significant. In order to minimize the effect of the prosecution delays on patent term, the USPTO implemented a policy of Patent Term Adjustment (PTA) procedure by which additional patent term is added to the standard 20 year patent term to compensate for excessive USPTO prosecution delays. For many patents, especially those in the pharmaceutical arts, the length of patent term can greatly affect the value of the patent. For these types of patents, as well as many other patents, the calculation of PTA becomes critically important.

The recent decision of Wyeth v. Kappos¹, which held that the method used by the USPTO to calculate PTA improperly limited the length of PTA, highlighted the importance of the issue of PTA. This article focuses on how to avoid PTA reduction resulting from the filing of information disclosure statements (IDS), and particularly 37 C.F.R. § 1.704 of the U.S. Patent Rules.

As set forth in 37 C.F.R. § 1.704, the filing of an IDS can result in a reduction of the PTA in several circumstances. Specifically, the filing of an IDS can reduce the PTA when an IDS is filed: (1) less than one month before the mailing of an office action or notice of allowance that requires the mailing of a supplemental office action or supplemental notice of allowance²; (2) after a response to an office action has been filed³; (3) after a decision by the Board of Patent Appeals and Interferences or Federal Court, less than one month before the mailing of an office action or notice of allowance that requires the mailing of a supplemental office action or supplemental notice of allowance⁴; and (4) after a notice of allowance has been mailed⁵. The PTA reduction resulting from the filing of an IDS in these circumstances generally is equal to the lesser of four months or the number of days required for the USPTO to mail a supplemental office action or supplemental notice of allowance in response to the IDS (situations (1), (3), and (4) above), or the number of days between the date the response to the office action was filed and the date the IDS was filed (situation (2) above).

Practitioners who prosecute U.S. applications that have pending foreign counterpart applications often receive prior art and/or examination reports from these foreign jurisdictions that must be submitted in IDSs at various stages of U.S. prosecution, including circumstances (1) – (4) above, and often during the later stages of U.S. prosecution. Therefore, the filing of these IDSs can trigger significant PTA reductions under 37 C.F.R. § 1.704.These reductions in PTA can be avoided, however, by filing a statement under 37 C.F.R. § 1.704(d).

37 C.F.R. § 1.704(d) states:

a paper containing only an information disclosure statement in compliance with  §§ 1.97 and 1.98 will not be considered a failure to engage in reasonable efforts to conclude prosecution (processing or examination) of the application under paragraphs (c)(6), (c)(8), (c)(9), or (c)(10) of this section if it is accompanied by a statement that each item of information contained in the information disclosure statement was first cited in any communication from a foreign patent office in a counterpart application and that this communication was not received by any individual designated in § 1.56(c) more than thirty days prior to the filing of the information disclosure statement. This thirty-day period is not extendable. (Emphasis added.)

Therefore, if an IDS citing newly-cited prior art from a communication from a foreign patent office is filed within thirty days of receipt along with the statement set forth in 37 C.F.R. § 1.704(d), the filing of the IDS will not result in a loss of PTA. Accordingly, 37 C.F.R. § 1.97(d) can effectively prevent the loss of PTA when IDSs citing newly-discovered prior art from foreign counterpart applications are filed late in prosecution.

Certification under 37 C.F.R. § 1.97(e)(1)

The statement under 37 C.F.R. § 1.704(d) should not be confused with the certification under  37 C.F.R. § 1.97(e)(1), which states that the items submitted in the IDS were cited in a communication from a foreign patent office not more than three months prior to the filing of the IDS. This certification under 37 C.F.R. § 1.97(e)(1) generally is used to avoid paying a fee when the IDS is filed after a first office action⁶, or to force the consideration of the IDS after a final office action or notice of allowance⁷. Unlike the statement under 37 C.F.R. § 1.704(d), the statement under 37 C.F.R. § 1.97(e)(1) has no effect on preventing PTA reduction.

Recommendations

To fully utilize the provisions of 37 C.F.R. § 1.704(d) and maximize PTA, all foreign associates should be made aware of the provisions of 37 C.F.R. § 1.704(d) and encouraged to send to the prosecuting U.S. attorney all prior art cited in the counterpart foreign patent applications as soon possible within the thirty day period. Because foreign associates can be considered to be an “individual” as defined in 37 C.F.R. § 1.56(c), the thirty day period may begin when the foreign associate receives the office action/references from the foreign patent office.  Prior art brought to the attention of the U.S. attorney by foreign associates should be submitted in an IDS as soon as possible upon receipt so that the art can be submitted in conjunction with the § 1.704(d) statement within the thirty day period. Also, as 37 C.F.R. § 1.704(d) applies to only “first cited” prior art, not previously known prior art, all relevant art should be cited as soon as possible during prosecution.

¹591 F.3d 1364, 93 U.S.P.Q.2d 1257, Civ. Act. No. 2009-1120 (Fed. Cir. 2010).
²See 37 C.F.R. § 1.704(c)(6).
³See 37 C.F.R. § 1.704(c)(8).
⁴See 37 C.F.R. § 1.704(c)(9).
⁵See 37 C.F.R. § 1.704(c)(10).
⁶See 37 C.F.R. § 1.97(c).
⁷See 37 C.F.R. § 1.97(d).

This advisory was prepared by Nutter's Intellectual Property practice. For more information, please contact your Nutter attorney at 617-439-2000.