Califorrniaa v. Vidal

Case: 22-1640 Document: 36 Page: 1 Filed: 11/07/2022

NOTE: This disposition is nonprecedential.

United States Court of Appeals for the Federal Circuit ______________________

EURICA CALIFORRNIAA, Plaintiff-Appellant

v.

KATHERINE K. VIDAL, UNDER SECRETARY OF COMMERCE FOR INTELLECTUAL PROPERTY AND DIRECTOR OF THE UNITED STATES PATENT AND TRADEMARK OFFICE, Defendant-Appellee ______________________

2022-1640 ______________________

Appeal from the United States District Court for the Eastern District of Virginia in No. 1:20-cv-00985-MSN- TCB, Judge Michael S. Nachmanoff. ______________________

Decided: Nov. 7, 2022 ______________________

EURICA CALIFORRNIAA, Mahopac, NY, pro se.

DANA KAERSVANG, Appellate Staff, Civil Division, United States Department of Justice, Washington, DC, for defendant-appellee. Also represented by BRIAN M. BOYNTON, DANIEL TENNY; JESSICA D. ABER, MEGHAN LOFTUS, Office of the United States Attorney for the

Case: 22-1640 Document: 36 Page: 2 Filed: 11/07/2022 2 CALIFORRNIAA v. VIDAL

Eastern District of Virginia, United States Department of Justice, Alexandria, VA; KAKOLI CAPRIHAN, BENJAMIN T. HICKMAN, THOMAS W. KRAUSE, BRIAN RACILLA, FARHEENA YASMEEN RASHEED, Office of the Solicitor, United States Patent and Trademark Office, Alexandria, VA. ______________________

Before LOURIE, DYK, and HUGHES, Circuit Judges. PER CURIAM. Eurica Califorrniaa appeals from the decision of the United States District Court for the Eastern District of Vir- ginia granting summary judgment in favor of the United States Patent and Trademark Office (“PTO”). See Califorr- niaa v. Hirshfeld, No. 1-20-cv-00985, 2021 WL 6196996 (E.D. Va. Dec. 20, 2021). We affirm. BACKGROUND Califorrniaa alleges that the PTO incorrectly calcu- lated the Patent Term Adjustment (“PTA”) for his patent, U.S. Patent 10,245,075 (the “’075 patent”), by improperly deducting 51 days due to applicant delay. Patent terms are generally extended by one day for each day of PTO delay, minus one day for each day during which the applicant fails to engage in reasonable efforts to conclude prosecution of the application. 35 U.S.C. § 154(b)(2)(C). 1 Congress delegated to the PTO the

Case: 22-1640 Document: 36 Page: 3 Filed: 11/07/2022 CALIFORRNIAA v. VIDAL 3

authority to define those situations that reflect a failure to engage in reasonable efforts to conclude prosecution of the patent. § 154(b)(2)(C)(iii). To avoid case-by-case de- terminations of what constitutes a failure to engage in reasonable efforts to conclude prosecution, it has promul- gated regulations outlining examples of such efforts. See 65 Fed. Reg. 56366, 56378–79 (Sept. 18, 2000). It has de- fined an applicant’s amendment of a patent application after it issues a notice of allowance as one such failure. 37 C.F.R. § 1.704(c)(10). 2 Following our January 23, 2019

(ii) With respect to adjustments to patent term made under the authority of paragraph (1)(B), an applicant shall be deemed to have failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of 3 months that are taken to respond to a notice from the Office making any rejection, objection, argument, or other re- quest, measuring such 3-month period from the date the notice was given or mailed to the applicant. (iii) The Director shall prescribe regulations establish- ing the circumstances that constitute a failure of an appli- cant to engage in reasonable efforts to conclude processing or examination of an application. 2 37 C.F.R. § 1.704(c)(10) (2019): Submission of an amendment under § 1.312 or other paper, other than a re- quest for continued examination in compliance with § 1.114, after a notice of allowance has been given or mailed, in which case the period of adjustment set forth in § 1.703 shall be reduced by the lesser of: (i) The number of days, if any, beginning on the date the amendment under § 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other pa- per; or (ii) Four months.

Case: 22-1640 Document: 36 Page: 4 Filed: 11/07/2022 4 CALIFORRNIAA v. VIDAL

decision in Supernus, the PTO revised its regulations gov- erning the calculation of PTA, including § 1.704(c)(10). Supernus Pharms., Inc. v. Iancu, 913 F.3d 1351 (Fed. Cir. 2019); 85 Fed. Reg. 36335, 36335 (June 16, 2020). This subsection was amended in June 2020 to (1) distinguish between after-allowance amendments expressly requested by the PTO, and those not, and (2) change the relevant timeframe for the calculation of a reduction in PTA. 37 C.F.R. § 1.704(c)(10) (2020) 3; 85 Fed. Reg. at 36335. After an extensive prosecution involving numerous amendments, the examiner found that Califorrniaa’s pa- tent could issue if minor additional changes were made to the claim language. C.A. 101–03. 4 The examiner made the amendment on his own authority and mailed the Notice of Allowance on December 11, 2018. C.A. 100. On January 7, 2019, Califorrniaa requested an additional interview, at- taching a new proposed amendment to the interview re- quest. C.A. 112–16. The interview was held the following day and included discussion of the potential amendment. Id. On January 10, 2019, Califorrniaa accordingly submit- ted a new amendment making minor changes (e.g., the ad- dition of a comma) to some of the examiner-amended claim limitations, and several substantive changes (e.g., the

Case: 22-1640 Document: 36 Page: 5 Filed: 11/07/2022 CALIFORRNIAA v. VIDAL 5

deletion of limitations) unrelated to the examiner amend- ment. C.A. 117–36. On February 26, 2019, the examiner responded and accepted the amendment. C.A. 140–161. The patent issued on April 2, 2019. C.A. 162. The PTO, in calculating PTA, subtracted 51 days for the time that the plaintiff's after-allowance amendment was pending pursuant to 37 C.F.R. § 1.704(c)(10) (2019). At the time of calculation, § 1.704(c)(10) required a reduc- tion of PTA for “[s]ubmission of an amendment under § 1.312 . . . after a notice of allowance has been given or mailed” by “the lesser of: (i) The number of days, if any, beginning on the date the amendment under § 1.312 or other paper was filed and ending on the mailing date of the Office action or notice in response to the amendment under § 1.312 or such other paper; or (ii) Four months.” Pursuant to 35 U.S.C. § 154(3)(B)(ii), Califorrniaa timely filed a request for redetermination of PTA. C.A. 163–165. Califorrniaa argued that his only possible course of action to address the examiner’s amendment was to file his own after-allowance amendment, and therefore his ac- tions did not constitute a failure to engage in reasonable efforts to conclude prosecution. The PTO found that the situation still fell within the rule, and that Califorrniaa would not benefit from an exception anyway because he sought changes unrelated to the examiner’s amendment and that it could have been made earlier. C.A. 6–7. Califorrniaa then sought review in the U.S. District Court for the Eastern District of Virginia under 35 U.S.C. § 145. Califorrniaa argued again that the PTA should not be reduced because the PTO’s rule that all after-allowance amendments constitute applicant delay was contrary to § 154(b)(2)(C). Califorrniaa also argued that (1) he had not approved the examiner’s amendment; and (2) that his PTA should be recalculated using the method outlined in the June 16, 2020 amendment to § 1.704(c)(10) because the prior version of the regulation was invalid in light of our

Case: 22-1640 Document: 36 Page: 6 Filed: 11/07/2022 6 CALIFORRNIAA v. VIDAL

ruling in Supernus, 913 F.3d at 1358–61. The court, apply- ing Chevron deference, concluded that the applicant’s filing of an after-allowance amendment met the criteria for a re- duction of PTA, and that Califorrniaa’s other arguments were forfeited because they were not made before the PTO. C.A. 18 n.³. The court then granted summary judgment in favor of the PTO. C.A. 15–19. Califorrniaa timely filed a request for rehearing, which was denied. C.A. 21–24. Califorrniaa then appealed the district court’s grant of the PTO’s motion for summary judgment to this court. C.A. 28. We have jurisdiction under 28 U.S.C. § 1295(a)(4)(C). DISCUSSION We review a grant of summary judgment according to the law of the regional circuit. Intra-Cellular Therapies, Inc. v. Iancu, 938 F.3d 1371, 1379 (Fed. Cir. 2019). The Fourth Circuit reviews grants of summary judgment de novo. Norfolk S. Ry. Co. v. City of Alexandria, 608 F.3d 150, 156 (4th Cir. 2010). Applying a de novo standard, we review the PTO’s PTA decision in accordance with the Administrative Procedure Act (“APA”). See 35 U.S.C. § 154(b)(4)(A); Chudik v. Hirshfeld, 987 F.3d 1033, 1039 (Fed. Cir. 2021). The APA requires that courts only “set aside agency action, findings, and conclusions” if they are “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” 5 U.S.C. § 706(2)(A). When reviewing an agency’s statutory interpretation, we apply the two-step framework estab- lished in Chevron, U.S.A., Inc. v. Nat. Res. Def. Council, Inc., 467 U.S. 837 (1984). The parties disagree as to whether Chevron applies, but, consistent with our prior de- cisions concerning PTA calculation, we find that it does. See Supernus, 913 F.3d at 1356–57; Intra-Cellular Thera- pies Inc. v. Iancu, 938 F.3d 1371, at 1379, 1383 (Fed. Cir. 2019); Gilead Scis., Inc. v. Lee, 778 F.3d 1341, 1346 (Fed. Cir. 2015).

Case: 22-1640 Document: 36 Page: 7 Filed: 11/07/2022 CALIFORRNIAA v. VIDAL 7

Califorrniaa challenges the validity of § 1.704(c)(10) under two different statutory subsections: 35 U.S.C. §§ 154(b)(2)(C)(i) and 154(b)(2)(C)(iii). We address each in turn. I Califorrniaa argues that § 1.704(c)(10) (2019), and the PTO’s calculation of applicant delay in accordance with that rule, violate § 154(b)(2)(C)(i) and our holding in Su- pernus. The PTO responds that this argument was for- feited and that its determination of PTA was consistent with § 154(b)(2)(C)(i) because all the time consumed by the PTO’s consideration of the amendment was attributa- ble to Califorrniaa’s decision to file it. The district court declined to consider this issue, finding it had been for- feited by not being argued before the PTO. We agree with the PTO on the merits, and we therefore do not reach the issue of forfeiture. Subsection 154(b)(2)(C)(i) mandates that “[t]he period of adjustment of the term of a patent . . . shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to con- clude prosecution of the application.” § 154(b)(2)(C)(i) (emphasis added). In Supernus, we found the language of § 154(b)(2)(C)(i) to be “plain, clear, and conclusive.” 913 F.3d at 135. We found that, pursuant to the plain lan- guage of the statute, “PTA cannot be reduced by a period of time during which there is no identifiable effort in which the applicant could have engaged to conclude prose- cution because such time would not be ‘equal to’ and would instead exceed the time during which an applicant failed to engage in reasonable efforts.” 913 F.3d at 1359. Applying that logic, we found that the PTO’s assessment of applicant delay in that case exceeded its statutory au- thority under step one of Chevron. Id. at 1360–61. Step one of Chevron asks whether Congress “directly addressed the precise question at issue.” Chevron, 467 U.S. at 842.

Case: 22-1640 Document: 36 Page: 8 Filed: 11/07/2022 8 CALIFORRNIAA v. VIDAL

As the statute is unambiguous, there was no need to pro- ceed to Chevron step two, and deference was not in play. Where the facts of Supernus and the present case dif- fer, however, is that the applicant in Supernus had no fea- sible actions it could have taken to conclude prosecution between the filing of its Request for Continued Examina- tion and the European Patent Office’s Notice of Opposi- tion. Here, Califorrniaa could have, at any time in the 51 days between the filing of his after-allowance amendment and the examiner’s acceptance of the proposal, withdrawn his after-allowance amendment, concluding prosecution. Therefore, unlike in Supernus, there was an “identifiable effort” in which Califorrniaa could have engaged to con- clude prosecution. That the PTO later amended § 1.704(c)(10) to change the period of pendency does not affect our decision. Nor can the later-amended version somehow apply to calcula- tion of PTA for the ’075 patent. The effective date of the amendment to the regulation was July 16, 2020, after the issuance of the ’075 patent and calculation of its PTA. 85 Fed. Reg. at 36,335. Because we resolve this issue on the merits, we do not reach the issue of forfeiture. II Califorrniaa further argues that § 1.704(c)(10) (2019), and the PTO’s calculation of applicant delay in accordance with that rule, violate § 154(b)(2)(C)(iii) because his ac- tions did not constitute a failure to engage in reasonable efforts to conclude prosecution since he was responding to an examiner-made amendment. The PTO responds that its interpretation of the statute to include all after-allow- ance amendments as applicant delay should be sustained, particularly given Chevron deference, and, regardless, Califorrniaa’s after-allowance amendment could have been made earlier. We agree with the PTO.

Case: 22-1640 Document: 36 Page: 9 Filed: 11/07/2022 CALIFORRNIAA v. VIDAL 9

Unlike the statutory terms at issue in Supernus, the meaning of “reasonable efforts” in subsection 154(b)(2)(C)(iii) is ambiguous here. See Gilead, 778 F.3d at 1346–49 (finding what constituted “failure to engage in reasonable efforts” not clearly addressed by Congress). Alt- hough subsection 154(b)(2)(C)(ii) provides one instance where Congress provided an example of applicant delay, the third subsection of the statute directs the PTO to pre- scribe other instances in which applicant behavior “consti- tutes a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an applica- tion.” 35 U.S.C. § 154(b)(2)(C)(iii). Therefore, Congress did not clearly answer whether after-allowance amendments constitute a failure to engage in reasonable efforts to con- clude prosecution and we must proceed to Chevron step two to decide this issue. In step two, Chevron requires determining “whether the [PTO’s] answer is based on a permissible construction of the statute.” Chevron, 467 U.S. at 842–43. At this stage of the Chevron analysis, an agency’s construction of a stat- utory scheme is afforded considerable weight. Id. at 844. Chevron teaches that, when Congress explicitly leaves a gap for an agency to fill, “[s]uch legislative regulations are given controlling weight unless they are arbitrary, capri- cious, or manifestly contrary to the statute.” Id. Therefore, we accept an agency’s construction of the statute even if the agency’s reading differs from what a court believes is the best statutory interpretation. Id. Here, Congress expressly delegated authority to “[t]he Director [to] prescribe regulations establishing the circum- stances that constitute a failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” 35 U.S.C. § 154(b)(2)(C)(iii). As permit- ted by statute, the PTO promulgated § 1.704(c)(10), which encompasses the precise situation in this case—when the applicant files an after-allowance amendment. “Such broad language demonstrates Congress intended the PTO

Case: 22-1640 Document: 36 Page: 10 Filed: 11/07/2022 10 CALIFORRNIAA v. VIDAL

to employ its expertise in identifying applicant conduct demonstrating a lack of ‘reasonable efforts to conclude pro- cessing or examination of an application.’” Gilead, 778 F.3d at 1349 (citing § 154(b)(2)(C)(iii)). After-allowance amend- ments predictably delay the close of prosecution, and we cannot say that it was arbitrary for the PTO to conclude that applicants that elect to file amendments after having their claims allowed generally should be charged with de- lay. We therefore find that the PTO’s interpretation of the statute was permissible here. Califorrniaa asserts that an exception should be made for after-allowance amendments made in response to ex- aminer-made amendments in the Notice of Allowance, as they could not have been raised earlier. But this is not the situation at hand. Califorrniaa filed a substantive after- allowance amendment unrelated to the minor amendment made by the examiner and he has not provided any reason that the amendment could not have been made earlier. C.A. 101–136. We decline to consider a situation not before us. CONCLUSION We have considered Califorrniaa’s remaining argu- ments but find them unpersuasive. For the foregoing rea- sons, we affirm the judgment of the district court. AFFIRMED

Footnotes

[1] 35 U.S.C. § 154(b)(2)(C): Reduction of period of ad- justment. — (i) The period of adjustment of the term of a patent un- der paragraph (1) shall be reduced by a period equal to the period of time during which the applicant failed to engage in reasonable efforts to conclude prosecution of the appli- cation.

[3] 37 C.F.R. § 1.704(c)(10) (2020): Submission of an amendment under § 1.312 or other paper, other than an amendment under § 1.312 or other paper expressly re- quested by the Office or a request for continued examina- tion in compliance with § 1.114, after a notice of allowance has been given or mailed, in which case the period of ad- justment set forth in § 1.703 shall be reduced by the num- ber of days, if any, beginning on the day after the date of mailing of the notice of allowance under 35 U.S.C. 151 and ending on the date the amendment under § 1.312 or other paper was filed.

[4] “C.A.” refers to Appellee’s Corrected Appendix.