On February 6, 2018, the Court of Appeals for the Federal Circuit ruled in Actelion Pharm., Ltd. v. Matal. This case deals with the sometimes mundane aspects of filling out the proper forms required for filing with the USPTO, and failure to do so can have major impacts downstream during and post-prosecution.
The facts of the case are as follows.
Actelion is the original applicant and owner of U.S. Patent No. 8,658,675 (‘675), for “Pyridin-4-yl derivatives.”
‘675 originated as the national phase application of PCT application PCT/IB2010/053224, filed on July 15, 2010. The 30-month deadline to enter the national phases was January 16, 2012. Actelion entered the U.S. national phase on January 12, 2012, when it filed its PTO-1390 form (i.e., U.S. national phase entry application form), copy of the international application, inventors’ oath, and its filing fees, consistent with 35 U.S.C. §371(c). On the form PTO-1390, Actelion did not check the box 3 on the old form, “This is an express request to begin national examination procedures (35 U.S.C. 371(f)) . . . . “ Incidentally, the 30-month deadline to enter the national phases expired on Martin Luther King Day, a federal holiday. Under PCT articles, if a deadline falls on a holiday of a member state, the deadline is automatically extended to the subsequent date. The USPTO issued a restriction requirement on April 26, 2013, which triggered the 14-month USPTO reply required of 35 U.S.C. §154(b)(1)(A)(i). This translates into 466-day, or 15-month and 11-day, after the U.S. national phase deadline. In other words, the restriction requirement was mailed 41 days beyond the 14-month response as required by of 35 U.S.C. §154(b)(1(A)(i) in order to prevent a patent term adjustment (PTA) delay that would extend the patent term. The application subsequently issued on February 25, 2014, as the ‘675 patent, with a PTA of 41 days. Actelion filed a request to recalculate PTA. This resulted in a reduction of PTA from 41 to 40 days by the USPTO. Actelion then filed a petition to reconsider under 37 C.F.R. §1.705, contending that it was entitled to 45 days of PTA, or at least 41 days, based on the original PTA assessment. This petition was summarily denied by the USPTO. In March 2016, Actelion then filed a federal suit pursuant to 35 U.S.C. §154(b)(4).
Actelion put forth two arguments. First, that it had fulfilled all requirements under 35 U.S.C. §371(c). Second, it argued regardless of whether pre- or post-versions of §154 applied, it made an “express request” under §371(f) in a preliminary amendment that it “earnestly solicits early examination.”
The Fed Circuit panel, comprised of Judges Lourie, O’Malley, and Wallach, ruled unanimously.
Regarding the first issue, whether a PTA calculation delay under §154 is based on compliance with all requirements in §371, the panel held:
[A] Delay calculation must be based on the date on which the entirety of §371 has been complied with, including §371(c) as well as §371(b) and §371(f). We conclude that, to commence the national stage [phase] early, Actelion was required to make an express request pursuant to §371(f) regardless of whether the pre- or -post-TCA version of §154(b)(1)(A)(i)(II) applies to the ‘675 patent.
The panel determined that the provisions of §154(b)(1)(A)(i)(II) only refer to “section 371” but do not refer to any particular subsection of §371. Therefore, if Congress wanted to specify specific subsections, it could have done so when enacting the PTA law. It did not. Thus, Actelion’s argument is unpersuasive on this issue.
As to the second issue, namely, whether making an implied request for early examination, rather than an express request for examination, by failing to check “box 3” on the national phase entry form but by making “similar” language in a preliminary amendment later in prosecution, is enough to satisfy the requirement of §371(f), the panel found that Actelion did not.
Neither the fact that using the PTO forms may be optional nor the availability of other §371(f)-compliant menas of making an express request excuses an applicant’s failure to make its intentions clear.
In other words, an Applicant must make state its intentions clearly when corresponding with the USPTO. If it wants to have examination as early as possible, it must indicate so clearly and unambiguously. Since Actelion merely used the casual “solicits early examination” language with no reference to §371(f), combined with the unchecked box 3 on the Form PTO-1390, could not be construed as a valid express and unambiguous election to enter examination as required under §371(f).
As to the third issue, whether the USPTO properly calculated the PTA delay under §154, the panel held that it did. The panel did not find that the USPTO had error in its determination of the PTA of the ‘675 patent when it tolled the date from January 17, 2012, or the next subsequent workday of the USPTO after the 30-month national phase entry date of January 16, 2012, given the federal holiday. Actelion’s argument that it should not be punished for a delay resulting from a federal holiday was outright rejected by the panel, because it was premised on an assumption that any inaction involving the application and the applicant should be entitled to benefit from.
Although the PTA statutes do serve a remedial purpose of restoring patent term lost during prosecution of an application, they only restore “undue delays in patent examination caused by the USPTO” as provided by Congress.
In other words, PTA is a process to remedy actual delays by the USPTO (and the applicant) in prosecuting the application, and not to delays resulting from non-working days when prosecution inaction is mandated by a federal holiday.
The takeaway here is to be sure to dot your ‘i’s and cross your ‘t’s, because it could mean the difference of an extra month (or several months or even years) to your patent term. This is especially true for non-U.S. applicants, most which are not used to PTAs since most countries (other than the U.S. and Korea) allow PTAs. Also, be sure to heed the advice of your patent paralegal since most are responsible for filling out and filing the forms required in patent prosecution.
 Actelion Pharm., Ltd. v. Lee, 216 F. Supp. 3d 680 (E.D. Va. 2016), aff’d Actelion Pharm., Ltd. v. Matal, 878 F.3d 1027 (Fed. Cir. 2018).
 The term “national phase” is from the PCT articles; “national stage” is a U.S. invention upon the U.S. accession to the PCT Treaty. Both are synonymous but for purposes of this posting, the term “national phase” will be used, consistent with the PCT terminology.
 See MPEP 1893: “ . . . The time delay is, however, the benefit most often recognized as primary. Ultimately, applicant might choose to submit the national stage [phase] application. The national stage [phase] is unique compared to a domestic national application in that:
(A) it is submitted later (i.e., normally 30 months from a claimed priority date as compared to 12 months for a domestic application claiming priority); and
(B) the status of the prior art is generally known before the national stage begins and this is not necessarily so in a domestic national application.”
 See Actelion, supra (slip op. at 6). Further, on the revised Form PTO-1390, express examination is now “box 1.”
 See PCT Art. 80.5.
 See MPEP 2731: A written restriction requirement, a written election of species requirement, a requirement for information under 37 CFR 1.105, an action under Ex parte Quayle, 1935 Comm’r Dec. 11 (1935), and a notice of allowability (PTOL-37) are each an action issued as a result of the examination conducted pursuant to 35 U.S.C. 131.
 See MPEP 2710: “utility and plant patents issuing on applications filed on or after May 29, 2000 are eligible for patent term adjustment provisions of 35 U.S.C. 154(b) and 37 CFR 1.702-1.705.”
 See Actelion, supra (slip op. at 9).
 Id. (slip op. at 12). See Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1354 (Fed. Cir. 2009) (holding that applications filed as continuations are not to be treated as divisionals).
 See 37 C.F.R. §1.491 (pre-AIA, application filed on or before Sept. 16, 2012):
(a) Subject to 35 U.S.C. 371(f), the national stage [phase] shall commence with the expiration of the applicable time limit under PCT Article 22(1) or (2), or under PCT Article 39(1)(a).
(b) An international application enters the national stage [phase] when the applicant has filed the documents and fees required by 35 U.S.C. 371(c) within the period set in §1.495.
 See PCT Art. 80.5 Expiration of a Non-Working Day or Official Holiday: if the expiration of any period during which any document or fee must reach a national Office . . . falls on a day . . . :
(iii) which, where such Office or organization is situated in more than one locality, is an official holiday in at least one of the localities in which said Office or organization is situated, and in circumstances where the national law applicable by that Office or organization provides, in respect of national applications, that, in such a case, such period shall expire on a subsequent day;
 See Actelion, supra (slip op. at 14).
 Id. See also Pfizer, Inc. v. Lee, 811 F.3d 466, 468 (Fed. Cir. 2016).