Court Opinion

ID: 9839480
Source: CourtListenerOpinion
Date Created: 2023-09-13 15:01:38.089545+00
Date Added: 2024-06-11T09:40:52.399038
License: Public Domain

Case: 22-1293    Document: 91    Page: 1    Filed: 08/28/2023

   United States Court of Appeals
       for the Federal Circuit
                  ______________________

                 IN RE: CELLECT, LLC,
                         Appellant
                  ______________________

       2022-1293, 2022-1294, 2022-1295, 2022-1296
                ______________________

     Appeals from the United States Patent and Trademark
 Office, Patent Trial and Appeal Board in Nos. 90/014,453,
 90/014,454, 90/014,455, 90/014,457.
                  ______________________

                 Decided: August 28, 2023
                  ______________________

     PAUL J. ANDRE, Kramer Levin Naftalis & Frankel LLP,
 Redwood Shores, CA, argued for appellant. Also repre-
 sented by JAMES R. HANNAH, LISA KOBIALKA; JONATHAN
 CAPLAN, JEFFREY PRICE, New York, NY.

    KAKOLI CAPRIHAN, Office of the Solicitor, United States
 Patent and Trademark Office, Alexandria, VA, argued for
 appellee Katherine K. Vidal. Also represented by THOMAS
 W. KRAUSE, AMY J. NELSON, BRIAN RACILLA, FARHEENA
 YASMEEN RASHEED.

     JEREMY LOWE, Leydig, Voit & Mayer, Ltd., Chicago, IL,
 for amicus curiae Alvogen PB Research & Development
 LLC. Also represented by KEELIN BIELSKI, STEVEN H.
 SKLAR.

    KURT A. MATHAS, Winston & Strawn LLP, Chicago, IL,
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 2                                           IN RE: CELLECT, LLC

 for amicus curiae Association for Accessible Medicines.
 Also represented by CLAIRE A. FUNDAKOWSKI, Washington,
 DC.

     KEVIN EDWARD NOONAN, McDonnell Boehnen Hulbert
 & Berghoff LLP, Chicago, IL, for amicus curiae Biotechnol-
 ogy Innovation Organization. Also represented by AARON
 VINCENT GIN, ALEXA L. GIRALAMO, DANIEL GONZALEZ, JR.,
 DONALD LOUIS ZUHN, JR.; HANSJORG SAUER, Biotechnology
 Innovation Organization, Washington, DC.

     PAUL BERGHOFF, McDonnell Boehnen Hulbert &
 Berghoff LLP, for amicus curiae Intellectual Property
 Owners Association. Also represented by HENRY HADAD,
 Bristol Myers Squibb, Lawrenceville, NJ.

     JEFFREY PAUL KUSHAN, Sidley Austin LLP, Washing-
 ton, DC, for amicus curiae Pharmaceutical Research and
 Manufacturers of America. Also represented by STEVEN J.
 HOROWITZ, Chicago, IL; DAVID EVAN KORN, Pharmaceuti-
 cal Research and Manufacturers of America, Washington,
 DC.

     DOUGLAS HALLWARD-DRIEMEIER, Ropes & Gray LLP,
 Washington, DC, for amici curiae Samsung Electronics Co.,
 Ltd., Samsung Electronics America, Inc. Also represented
 by SCOTT ANTHONY MCKEOWN; JAMES LAWRENCE DAVIS,
 JR., East Palo Alto, CA; ALEXANDER E. MIDDLETON, New
 York, NY.
                 ______________________

      Before LOURIE, DYK, and REYNA, Circuit Judges.
 LOURIE, Circuit Judge.
     Cellect, LLC (“Cellect”) appeals from four ex parte reex-
 amination decisions of the United States Patent and Trade-
 mark Office (“USPTO”) Patent Trial and Appeal Board
 (“the Board”) affirming the unpatentability of: (1) claims
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 IN RE: CELLECT, LLC                                           3

 22, 42, 58, and 66 of U.S. Patent 6,982,742 (“the ’742 pa-
 tent”); (2) claims 1, 17, 19, 21, 22, 27, 49, 55, and 61 of U.S.
 Patent 6,424,369 (“the ’369 patent”); (3) claims 1, 5, 11, 33,
 34, 58, and 64 of U.S. Patent 6,452,626 (“the ’626 patent”);
 and (4) claims 25–29 and 33 of U.S. Patent 7,002,621 (“the
 ’621 patent”) for obviousness-type double patenting
 (“ODP”). Ex parte Cellect LLC, Appeal 2021-005302
 (P.T.A.B. Feb. 17, 2020), J.A. 27–49; Ex parte Cellect LLC,
 Appeal 2021-005046 (P.T.A.B. Feb. 18, 2020), J.A. 51–73;
 Ex parte Cellect LLC, Appeal 2021-005258 (P.T.A.B. Feb.
 19, 2020), J.A. 76–97; Ex parte Cellect LLC, Appeal 2021-
 005303 (P.T.A.B. Feb. 16, 2020), J.A. 2–24. 1 For the rea-
 sons provided below, we affirm.
                         BACKGROUND
      Cellect owns the ’742, ’369, ’626, and ’621 patents (“the
 challenged patents”), each of which is directed to devices
 (e.g., personal digital assistant devices or phones) compris-
 ing image sensors. The challenged patents are all interre-
 lated, each claiming priority from a single application that
 issued as U.S. Patent 6,275,255 (“the ’255 patent”). The
 ’369 and ’626 patents are continuations-in-part of the ’255
 patent. The ’742 patent is a continuation-in-part of the ’369
 patent, and the ’621 patent is a continuation-in-part of the
 ’626 patent. U.S. 6,862,036 (“the ’036 patent”), another
 member of this family, is a continuation of the ’626 patent.
      Each of the challenged patents was granted Patent
 Term Adjustment (“PTA”) for USPTO delay during prose-
 cution pursuant to pre-AIA 35 U.S.C. § 154(b). Because
 each family member patent claims priority from the same
 application, each would have expired on the same day but
 for the individual grants of PTA. None of the patents was

     1   The four appeals for ex parte reexamination issued
 by the Board essentially contain the same language and
 analysis. We treat Appeal 2021-005302 as representative.
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 4                                          IN RE: CELLECT, LLC

 subject to a terminal disclaimer during prosecution, and
 the challenged patents are all expired, even after factoring
 in the grants of PTA. The relationship of the applications
 and issued patents, including the individual grants of PTA,
 is indicated in the figure

     Cellect sued Samsung Electronics, Co. (“Samsung”) for
 infringement of the challenged patents in the United
 States District Court for the District of Colorado. Samsung
 then requested the underlying ex parte reexaminations, as-
 serting that the patents were unpatentable based on ODP,
 which was not raised by the examiner during prosecution.
 In each reexamination proceeding, the examiner issued a
 Final Office Action determining that the challenged claims
 were obvious variants of Cellect’s prior-expiring reference
 patent claims. For the four ex parte reexamination pro-
 ceedings, the asserted claims and ODP invalidating refer-
 ence patents are indicated in the table, with representative
 claims indicated in bold.
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 IN RE: CELLECT, LLC                                        5

     The invalidation of all claims under ODP can be traced
 back to the ’036 patent, which is the only family member
 that did not receive a grant of PTA and thus retained an
 expiration date twenty years after the filing of the priority
 patent application. Specifically, the ’621 patent claims
 were found to be unpatentable over the ’626 patent claims,
 which were found to be unpatentable over the ’369 patent
 claims. The ’742 patent claims were also found to be un-
 patentable over the ’369 patent claims. The ’369 patent
 claims were themselves found to be unpatentable over the
 ’036 patent claims. Thus, although the ODP invalidating
 reference patents form a network across the four ex parte
 reexamination proceedings, all invalidated claims can be
 traced back to the single family member patent that did not
 receive a grant of PTA: the ’036 patent.
     Cellect appealed the rejection of the claims of the chal-
 lenged patents to the Board. Cellect noted that under No-
 vartis AG v. Ezra Ventures LLC, 909 F.3d 1367 (Fed. Cir.
 2018), ODP does not invalidate a validly obtained Patent
 Term Extension (“PTE”) under 35 U.S.C. § 156, and argued
 that the Board should similarly hold that ODP cannot ne-
 gate a statutory grant of PTA. That is, Cellect argued that
 determining unpatentability under ODP should be based
 on the expiration dates of the patents before any PTA is
 added to the term.
     Cellect further argued that an ODP rejection is not
 proper under the equitable principles underlying ODP, in-
 cluding (1) preventing the receipt of an improper timewise
 extension of a patent term, and (2) preventing split owner-
 ship of related patents and subsequent potential harass-
 ment by multiple owners or assignees. Cellect asserted
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 6                                           IN RE: CELLECT, LLC

 that no terminal disclaimer could be filed to cure the rejec-
 tion since the patents had expired, but that it had promised
 not to sell its expired patents. That, Cellect contended, ab-
 rogated the risk of harassment by multiple owners or as-
 signees.       Cellect also argued that the ex parte
 reexamination requests were not properly granted because
 the examiner had allegedly considered ODP during prose-
 cution of the challenged patents, and so none of the re-
 quests presented a substantial new question of
 patentability, a requirement for a proper ex parte reexami-
 nation.
      In each of the four appeals from ex parte reexamina-
 tion, the Board sustained the examiner’s determinations
 that the asserted claims of the challenged patents were un-
 patentable under ODP. The Board further considered
 whether or not an ODP analysis on a patent that has been
 granted PTA should be based on the expiration date of the
 patent with PTA or without PTA. First, the Board com-
 pared the cases on appeal for reexamination to that in
 Merck & Co. v. Hi-Tech Pharmacal Co., 482 F.3d 1317 (Fed.
 Cir. 2007), a case in which a patent owner had filed a ter-
 minal disclaimer to overcome an ODP rejection, after
 which that patent was awarded PTE. There, as the Board
 noted, we held that “a patent term extension under [35
 U.S.C.] § 156 is not foreclosed by a terminal disclaimer.”
 Id. at 1322; J.A. 33. Stated otherwise, the Board noted that
 a “patent term extension is from the expiration date result-
 ing from the terminal disclaimer and not from the date the
 patent would have expired in the absence of the terminal
 disclaimer.” Merck, 482 F.3d at 1322–23; J.A. 33.
     The Board also compared the cases on appeal to that in
 Novartis, a case in which we addressed the interaction be-
 tween ODP and PTE in the absence of a terminal dis-
 claimer. 909 F.3d at 1367. There, as the Board noted, we
 held that, “as a logical extension of [the] holding in Merck
 & Co. v. Hi-Tech,” ODP should be considered from the
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 IN RE: CELLECT, LLC                                         7

 expiration date of the patent before the addition of PTE.
 Id. at 1373–74.
     In the four underlying appeals for ex parte reexamina-
 tion, the Board framed the issue as a question of how PTA
 affects an ODP analysis and whether an ODP analysis
 should be based on the expiration date of a patent with or
 without any granted PTA added. J.A. 35–38. The Board
 concluded that Cellect’s argument that a judge-made doc-
 trine (i.e., ODP) cannot cut off a statutorily authorized time
 extension (i.e., PTA) was unpersuasive because it ignored
 the text of § 154 and the holding of Novartis. J.A. 35. First,
 the Board concluded that the reasoning in the precedent,
 including Merck, was based on differences between the
 statutory language in § 156 and § 154. J.A. 35–36. Second,
 the Board found that the statutory language in
 § 154(b)(2)(B) makes clear that any terminal disclaimer
 should be applied after any PTA is granted or, in other
 words, that a PTA cannot adjust a term beyond the dis-
 claimed date in any terminal disclaimer. J.A. 36–37. It
 therefore concluded that, unlike PTE, a grant of PTA shall
 not extend the term of a patent past the date of a terminal
 disclaimer. J.A. 38.
      The Board also reasoned that terminal disclaimers
 arise almost exclusively in situations to overcome ODP re-
 jections, and so Congress, by addressing terminal disclaim-
 ers in § 154, effectively addresses ODP. JA. 37. The Board
 further reasoned that this court has stated that ODP “pre-
 vent[s] an inventor from securing a second, later expiring
 patent” for an invention covered by a patent that was filed
 at the same time but that has a different patent term due
 to a grant of PTA. AbbVie Inc. v. Mathilda & Terence Ken-
 nedy Inst. of Rheumatology Tr., 764 F.3d 1366, 1373 (Fed.
 Cir. 2014); J.A. 38. It found that this rationale applied.
 J.A. 38.
     Based on those findings and reasoning, the Board held
 that both ODP and terminal disclaimers should be
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 8                                           IN RE: CELLECT, LLC

 considered after any PTA. J.A. 38. That is, any ODP anal-
 ysis or determination, whether or not a terminal disclaimer
 is required, should be based on the adjusted expiration date
 of the patent.
     The Board further found that the asserted claims
 would have been obvious in view of the respective invali-
 dating ODP references and noted that Cellect did not dis-
 pute that fact. J.A. 43. Cellect instead focused its
 argument on whether or not ODP could cut short a grant
 of PTA. The Board also found that Cellect received an un-
 justified timewise extension of patent term for the asserted
 claims of the challenged patents and that a risk of divided
 ownership, and subsequent harassment by multiple as-
 signees, remained active. J.A. 44–46. Finally, the Board
 found that ODP was a substantial new question of patent-
 ability and that Cellect’s arguments that the examiner had
 considered ODP during prosecution lacked merit. J.A. 46.
 In particular, the Board determined that there was no in-
 dication that the examiner had considered ODP during
 prosecution of the challenged patents. J.A. 46. Further,
 the Board concluded that the examiner’s knowledge of
 other Cellect-owned patents, or his willingness to issue
 ODP rejections in the prosecution of other Cellect-filed ap-
 plications, did not amount to a finding that the examiner
 had considered ODP in the prosecution of the challenged
 patents. J.A. 46.
     The Board sustained the finding of unpatentability of
 the claims under ODP, and Cellect appealed. We have ju-
 risdiction under 28 U.S.C. § 1295(a)(4)(A).
                         DISCUSSION
     Cellect raises three challenges on appeal. First, Cellect
 contends that the Board erred in determining that whether
 or not a patent is unpatentable for ODP is determined
 based on the date of expiration of a patent that includes
 any duly granted PTA pursuant to 35 U.S.C. § 154. Sec-
 ond, Cellect contends that the Board erred in failing to
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 IN RE: CELLECT, LLC                                         9

 consider the equitable concerns underlying the finding of
 ODP in the ex parte reexamination proceedings. Third,
 Cellect contends that the Board erred in finding a substan-
 tial new question of patentability in the underlying ex parte
 reexaminations, and thus that the reexamination proceed-
 ings were improper. We address each argument in turn.
     We may not set aside the Board’s decisions unless they
 were “arbitrary, capricious, an abuse of discretion, unsup-
 ported by substantial evidence, or otherwise not in accord-
 ance with law.” In re Sullivan, 362 F.3d 1324, 1326 (Fed.
 Cir. 2004); 5 U.S.C. § 706(2)(A). ODP is a question of law
 that we review de novo. In re Emert, 124 F.3d 1458, 1460
 (Fed. Cir. 1997). Whether or not a substantial new ques-
 tion of patentability exists is a question of fact that we re-
 view for substantial evidence. In re Swanson, 540 F.3d
 1368, 1375, 1381 (Fed. Cir. 2008). “Substantial evidence is
 more than a mere scintilla and means such relevant evi-
 dence as a reasonable mind might accept as adequate to
 support a conclusion.” Celgene Corp. v. Peter, 931 F.3d
 1342, 1349 (Fed. Cir. 2019) (quotation marks and citations
 omitted).
                               I
     We first consider Cellect’s challenge to the Board’s de-
 termination that the unpatentability of claims under ODP
 must be based on the date of expiration of a patent that
 includes any duly granted PTA pursuant to 35 U.S.C.
 § 154. That statute, in relevant part, reads as follows:
     Contents and term of patent; provisional rights.
     (b) Adjustment of Patent Term.—
         (1) Patent term guarantees.—
             (A) Guarantee of prompt patent and trademark
             office responses.—Subject to the limitations
             under paragraph (2), if the issue of an original
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 10                                           IN RE: CELLECT, LLC

            patent is delayed due to the failure of the Pa-
            tent and Trademark Office to—
                (i)–(iv) [providing for appropriate notifica-
                tions and USPTO response times],
                the term of the patent shall be extended 1
                day for each day after the end of the period
                specified in clause (i), (ii), (iii), or (iv), as the
                case may be, until the action described in
                such clause is taken.
            (B) Guarantee of no more than 3-year applica-
            tion pendency.—Subject to the limitations un-
            der paragraph (2), if the issue of an original
            patent is delayed due to the failure of the
            United States Patent and Trademark Office to
            issue a patent within 3 years after the actual
            filing date of the application under section
            111(a) in the United States or, in the case of an
            international application, the date of com-
            mencement of the national stage under section
            371 in the international application, not includ-
            ing—
                (i)–(iii) [providing for timing exceptions],
            the term of the patent shall be extended 1 day
            for each day after the end of that 3-year period
            until the patent is issued.
            (C) Guarantee of adjustments for delays due to
            derivation proceedings, secrecy orders, and ap-
            peals.—Subject to the limitations under para-
            graph (2), if the issue of an original patent is
            delayed due to—
                (i)–(iii) [providing for delay conditions re-
                lated to derivation proceedings, secrecy or-
                ders, and appeals],
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 IN RE: CELLECT, LLC                                          11

              the term of the patent shall be extended 1 day
              for each day of the pendency of the proceeding,
              order, or review, as the case may be.
           (2) Limitations.—
              ***
              (B) Disclaimed term.—
              No patent the term of which has been dis-
              claimed beyond a specified date may be ad-
              justed under this section beyond the expiration
              date specified in the disclaimer.
              (C) Reduction of period of adjustment.—
                    (i) The 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 ef-
                    forts to conclude prosecution of the applica-
                    tion.
     35 U.S.C. § 154(b) (emphases added).
      Because the arguments in this case involve comparison
 between § 154 and § 156, we also set forth the relevant text
 of § 156.
     Extension of patent term
     (a) The term of a patent which claims a product, a
     method of using a product, or a method of manufactur-
     ing a product shall be extended in accordance with this
     section from the original expiration date of the patent,
     which shall include any patent term adjustment
     granted under section 154(b), if—
           (1)–(5) [providing requirements for a grant of PTE]
     ***
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 12                                           IN RE: CELLECT, LLC

      (c)(3) The term of a patent eligible for extension under
      subsection (a) shall be extended by the time equal to
      the regulatory review period for the approved product
      which period occurs after the date the patent is issued,
      except that . . . if the period remaining in the term of a
      patent after the date of the approval of the approved
      product under the provision of law under which such
      regulatory review occurred when added to the regula-
      tory review period as revised under paragraphs (1) and
      (2) exceeds fourteen years, the period of extension shall
      be reduced so that the total of both such periods does
      not exceed fourteen years;
      ***
      (g)(6) A period determined under any of the preceding
      paragraphs is subject to the following limitations:
            (A) If the patent involved was issued after the date
            of enactment of this section, the period of extension
            determined on the basis of the regulatory review
            period determined under any such paragraph may
            not exceed five years.
            (B) If the patent involved was issued before the
            date of the enactment of this section and—
               (i)–(iii) [providing for exceptions pertaining to
               exemptions, major health or environmental
               health effects tests, or clinical investigations
               before such date of the approved product], . . .
            the period of extension determined on the basis of
            the regulatory review period determined under any
            such paragraph may not exceed five years.
 35 U.S.C. § 156(a), (c)(3), (g)(6) (emphases added).
     Cellect argues that PTA and PTE should be factored
 into an ODP analysis in the same way, i.e., determining
 whether or not claims are unpatentable under ODP based
 on their expiration dates before the addition of any granted
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 IN RE: CELLECT, LLC                                        13

 PTA or PTE. Cellect alleges that our precedent, legislative
 intent, and the statutory language all dictate this outcome.
 First, Cellect asserts that Novartis holds that a statutorily
 authorized extension of patent term (i.e., PTE) cannot be
 terminated by a judicial doctrine, here ODP. 909 F.3d at
 1375. Because PTA and PTE are both statutorily author-
 ized extensions of term, Cellect contends that ODP cannot
 cut off PTA and that whether or not claims are unpatenta-
 ble under ODP should be based on the expiration date that
 does not include the addition of any duly granted PTA.
     Further, Cellect argues that PTA and PTE have simi-
 lar statutory limitations. Cellect asserts that PTE is lim-
 ited in that the patent owner must choose one patent to
 receive a term extension and that PTA is limited in that a
 grant of PTA cannot cause the patent’s term to exceed the
 expiration date specified in a terminal disclaimer, pursu-
 ant to § 154(b)(2)(B). Cellect further asserts that, under
 the Board’s interpretation of § 154(b), any adjustment to
 related patents would invalidate them under ODP, and the
 only way to avoid wholesale invalidation of related patents
 would be to file preemptive terminal disclaimers. That,
 Cellect asserts, would be incompatible with and would fun-
 damentally change continuations practice.
     In addition, Cellect argues that legislative intent illus-
 trates that PTE and PTA were meant to be mandatory
 term adjustment and extension provisions that restore pa-
 tent term lost to different administrative delays. Cellect
 notes that each statutory provision states that the exten-
 sion “shall” be granted when particular conditions are met.
 35 U.S.C. § 156(a) (stating that an extension “shall” be
 granted), 35 U.S.C. § 154(b)(1)(A), (b)(1)(B), and (b)(1)(C)
 (stating that “the term of the patent shall be extended”).
     Cellect is supported by amici representing Biotechnol-
 ogy Innovation Organization and Pharmaceutical Re-
 search and Manufacturers of America (“PhRMA”).
 Intellectual Property Owners of America, writing in
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 14                                       IN RE: CELLECT, LLC

 support of neither party, also urges reversal of the Board’s
 decision.
      The USPTO responds that, as a threshold matter, Cel-
 lect does not dispute that the challenged and reference pa-
 tents are commonly owned, that the challenged patents
 expire after the reference patents, or that all challenged
 claims are patentably indistinct over claims in the refer-
 ence patents.
     The USPTO further responds that statutory language
 and precedent clearly illustrate that PTA and PTE should
 be considered differently from each other when determin-
 ing whether or not claims are unpatentable under ODP. In
 particular, the USPTO argues that, while an extension
 pursuant to PTE is added to the patent term after a con-
 sideration of ODP, see Novartis, 909 F.3d at 1375, an ad-
 justment pursuant to PTA should be added to the patent
 term before a consideration of ODP. The USPTO argues
 that our precedent and the statutory language are clear
 that PTE and PTA should be considered differently when
 analyzing ODP.
      The USPTO argues that precedent does not hold that
 ODP does not apply to patents with PTA. Citing AbbVie,
 the USPTO asserts that, when a situation arises where re-
 lated patents filed at the same time claim overlapping sub-
 ject matter yet have different expirations due to PTA, ODP
 still applies to ensure that the applicant does not receive
 an unjust timewise extension of patent term. AbbVie, 764
 F.3d at 1373. Further, the USPTO asserts that Novartis’s
 statement that a judge-made doctrine such as ODP cannot
 be used to cut off a statutorily granted term extension can-
 not be viewed in a vacuum, and it is limited to the applica-
 tion of ODP to a patent with PTE. There is nothing in that
 case, the USPTO asserts, that suggests that it should be
 extended to hold that patents with extended terms due to
 PTA cannot be subject to ODP rejections.
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 IN RE: CELLECT, LLC                                       15

     The USPTO also argues that the statutory language is
 clear that terminal disclaimers cut short PTA but not PTE.
 In particular, the USPTO notes that § 154 mentions termi-
 nal disclaimers, but § 156 does not.
     The USPTO further notes that while both statutory
 provisions indicate that an extension or adjustment “shall”
 be granted if various conditions are met, 35 U.S.C. § 156(a);
 35 U.S.C. § 154(b)(1)(A), (b)(1)(B), and (b)(1)(C), the re-
 quired conditions are limited by the presence of a terminal
 disclaimer in PTA but not PTE, 35 U.S.C. § 154(b)(2)(B).
 That statutory difference, the USPTO contends, indicates
 that Congress intended to treat the two frameworks differ-
 ently from each other. The USPTO asserts that differential
 treatment was confirmed in Merck.
     The USPTO’s position is supported by amici represent-
 ing Alvogen PB Research & Development LLP, the Associ-
 ation for Accessible Medicines, and Samsung Electronics
 (Samsung Electronics Co., Ltd. and Samsung Electronics
 America, Inc.). We appreciate the several amicus briefs
 and have considered the views they expressed.
     First, we note that an ODP determination depends on
 an assessment of obviousness, i.e., whether the claims of a
 later-expiring patent would have been obvious over the
 claims of an earlier-expiring patent owned by the same
 party. If so, absent a terminal disclaimer, the later-expir-
 ing claims are invalid. Application of that determination
 requires determining which is the later-expiring patent,
 which is why the date when PTA or PTE is applied matters.
     Proceeding to the merits, we agree with the USPTO
 that PTA and PTE should be treated differently from each
 other when determining whether or not claims are un-
 patentable under ODP. PTA and PTE are dealt with in
 different statutes and deal with differing circumstances.
 We conclude that, while the expiration date used for an
 ODP analysis where a patent has received PTE is the expi-
 ration date before the PTE has been added, the expiration
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 16                                         IN RE: CELLECT, LLC

 date used for an ODP analysis where a patent has received
 PTA is the expiration date after the PTA has been added.
 To say that PTA and PTE should be factored into an ODP
 analysis in the same manner merely because they both pro-
 vide statutorily authorized time extensions that restore pa-
 tent term due to various administrative delays, as Cellect
 argues, is an unjustified attempt to force disparate statutes
 into one.
      ODP is a judicially created doctrine that has its roots
 in 35 U.S.C. § 101, which states that an inventor may ob-
 tain “a patent” (i.e., a single patent) for an invention. In re
 Lonardo, 119 F.3d 960, 965 (Fed. Cir. 1997). ODP “is in-
 tended to prevent a patentee from obtaining a time-wise
 extension of patent for the same invention or an obvious
 modification thereof” and prevents an inventor from claim-
 ing a second patent for claims that are not patentably dis-
 tinct from the claims of a first patent. Id. A crucial purpose
 of ODP is to prevent an inventor from securing a second,
 later-expiring patent for non-distinct claims. This purpose
 applies equally to situations in which the later patents
 have received grants of PTA resulting from examination
 delays at the USPTO. AbbVie, 764 F.3d at 1373. Terminal
 disclaimers, which may be filed to overcome an ODP rejec-
 tion assuming that the first patent has not yet expired, are
 provided for in 35 U.S.C. § 253 and 37 C.F.R. § 1.321. No
 terminal disclaimers were filed by Cellect, and the patents
 at issue have all expired, precluding any late filings of ter-
 minal disclaimers.
     Our case precedent has clearly delineated how a patent
 that has received PTE, a statutorily authorized extension,
 interacts with ODP, a doctrine that limits the term of a pa-
 tent or, at least, ties later-filed, commonly owned, obvious
 variations to the expiration date of an earlier-filed refer-
 ence patent. In Merck, we held that PTE is not foreclosed
 by a terminal disclaimer. 482 F.3d at 1322, 1324. That
 holding was based on the fact that, while § 156 does not
 expressly reference terminal disclaimers, it provides for
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 IN RE: CELLECT, LLC                                        17

 other requirements that must be met to obtain a PTE and
 that the extension “shall” run from the expiration date of
 the patent, as adjusted under § 154(b) to account for any
 USPTO delays.        Id. at 1321–22.      We noted that
 § 154(b)(2)(B) expressly excludes patents in which a termi-
 nal disclaimer was filed from the benefit of a term adjust-
 ment beyond that disclaimed date for delays caused by the
 USPTO, but that no similar prohibition existed in § 156.
 Id. at 1322. We therefore concluded that the calculation of
 a grant of PTE on a patent that has a terminal disclaimer
 “is from the expiration date resulting from the terminal
 disclaimer and not from the date the patent would have ex-
 pired in the absence of the terminal disclaimer.” Id. at
 1322–23.
     The holding in Merck is premised on the fact that § 154
 contains requirements separate and distinct from those in
 § 156 that indicate a congressional intent to speak to ter-
 minal disclaimers and ODP in the context of PTA. We ex-
 tended this logic in Novartis, where we held that ODP does
 not invalidate a validly obtained PTE. 909 F.3d at 1373.
 There, we noted that, “if a patent, under its original expi-
 ration date without a PTE, should have been (but was not)
 terminally disclaimed because of [ODP], then this court’s
 [ODP] case law would apply, and the patent could be inval-
 idated,” but that “if a patent . . . is valid under all other
 provisions of law, then it is entitled to the full term of its
 PTE.” Id. at 1374
     Together, Merck and Novartis establish that ODP for a
 patent that has received PTE should be applied based on
 the expiration date (adjusted to a disclaimed date if a ter-
 minal disclaimer has been filed) before the PTE is added,
 so long as the extended patent is otherwise valid without
 the extension. For the first time, here, we address how an-
 other statutorily authorized extension, PTA, interacts with
 ODP. Even though both PTA and PTE are statutorily au-
 thorized extensions, and each serves to recover lost term,
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 18                                        IN RE: CELLECT, LLC

 each has its own independent framework established
 through an independent statutory schema.
     Cellect relies heavily on Novartis for its argument that
 any statutorily mandated extension, including PTA and
 PTE, cannot be cut short by a judge-made doctrine like
 ODP. But that is not an accurate reading of that holding.
 In Novartis, we held that the presence of ODP would not
 cut off a duly granted PTE under § 156. Stated otherwise,
 whether or not claims are unpatentable for ODP is deter-
 mined in view of the expiration date of the patents before
 any PTE is added. In Novartis, we merely “decline[d]” to
 allow “a judge-made doctrine [to] cut off a statutorily-au-
 thorized time extension.” Novartis, 909 F.3d at 1375. But
 there is no conflict between ODP and § 154. The PTE and
 PTA statutes have quite distinct purposes. PTE is de-
 signed to effectively extend the overall patent term for a
 single invention due to regulatory delays in product ap-
 proval. PTA is designed to extend the term of a particular
 patent due to delays in the processing of that patent. There
 is nothing in the PTA statute to suggest that application of
 ODP to the PTA-extended patent term would be contrary
 to the congressional design. Indeed, Cellect’s interpreta-
 tion of the PTA statue would effectively extend the overall
 patent term awarded to a single invention contrary to Con-
 gress’s purpose by allowing patents subject to PTA to have
 a longer term than the reference patent. The USPTO’s ap-
 proach merely recognizes the distinct purposes and inter-
 pretation of the two statutes. It does not allow a judge-
 made doctrine to restrict the scope of the PTA statute.
     As the USPTO argues, our case law and the statutory
 language dictate an outcome where an ODP analysis must
 be performed on patents that have received PTA based on
 the expiration date including PTA. In AbbVie, we held that
 ODP continues to apply where two patents that claim the
 same invention have different expiration dates, including
 where the different expiration date is due to a grant of PTA.
 764 F.3d at 1373–74. Here, we have related patents that
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 IN RE: CELLECT, LLC                                       19

 claim priority from the same application that, as conceded
 by Cellect, claim overlapping subject matter and that have
 different expiration dates only because of PTA. Thus, un-
 der AbbVie, ODP still applies to ensure that the applicant
 is not receiving an unjust extension of time.
     While Merck and Novartis do not directly govern this
 case because they address PTE, they inform our analysis
 because they recognize the differences between PTA and
 PTE.
     In Merck and Novartis, the holdings were premised on
 meaningful and substantive differences evincing a clear
 congressional intent to constitute PTE and PTA as differ-
 ent statutory frameworks. In particular, those cases set
 forth how § 154 clearly states that PTA “shall” be granted
 when certain requirements are met.                 35 U.S.C.
 § 154(b)(1)(A), (b)(1)(B), and (b)(1)(C). But those require-
 ments include limitations that are separate and distinct
 from those in the PTE framework, including the inability
 to extend a term past any date in a filed terminal dis-
 claimer. Compare 35 U.S.C. § 154(b)(2)(B) with 35 U.S.C.
 § 156(c)(3), and (g)(6) (providing for statutory limitations
 on length of PTE and number of patents that can be ex-
 tended).
      In addition, while § 154(b)(2)(B)’s provision regarding
 terminal disclaimers is not directly applicable to the pre-
 sent case since none were filed, it remains critical in our
 analysis of the statute. Section 154(b)(2)(B) provides that
 “No patent the term of which has been disclaimed [pursu-
 ant to 35 U.S.C. § 253] beyond a specified date may be ad-
 justed under this section beyond the expiration date
 specified in the disclaimer.” Cellect had the opportunity to
 file terminal disclaimers in this case during both prosecu-
 tion and ex parte reexamination. And, of course, the exam-
 iners had the opportunity, and perhaps the obligation, to
 reject certain of the pending claims, but they did not do so.
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 20                                        IN RE: CELLECT, LLC

     Terminal disclaimers are provided for in 35 U.S.C.
 § 253(a), which, in relevant part, provides that “A patentee,
 whether of the whole or any sectional interest therein,
 may, on payment of the fee required by law, make dis-
 claimer of any complete claim, stating therein the extent of
 his interest in such patent.” Title 37 of the Code of Federal
 Regulations, § 1.321 includes information on what a termi-
 nal disclaimer must include to be effective. 37 C.F.R.
 § 1.321. In particular, the regulation provides that a pa-
 tentee may disclaim any complete claim or claims in a pa-
 tent, id. § 1.321(a), or may disclaim or dedicate to the
 public the entire term, or any terminal part of the term, of
 a patent to be granted, id. § 1.321(b), (c).
     Terminal disclaimers are almost always filed to over-
 come an ODP rejection, so terminal disclaimers and ODP
 remain inextricably intertwined. See Boehringer Ingel-
 heim Int’l GmbH v. Barr Lab’ys, Inc., 592 F.3d 1340, 1346
 (Fed. Cir. 2010). As the Board stated, ODP and terminal
 disclaimers are “two sides of the same coin: the problem
 and the solution.” J.A. 37. Given the interconnection of
 ODP and terminal disclaimers as “two sides of the same
 coin,” J.A. 37, the statutory recognition of the binding
 power of terminal disclaimers in § 154(b)(2)(B) is tanta-
 mount to a statutory acknowledgement that ODP concerns
 can arise when PTA results in a later-expiring claim that
 is patentably indistinct.
     Terminal disclaimers were the solution to the problems
 created by the multiple challenged patents. If terminal dis-
 claimers had been filed in this case, the provisions of
 § 154(b)(2)(B) would have come into play. Congress in-
 tended that, when a terminal disclaimer has been entered
 in a patent subject to PTA, no patent (or claim) may be ex-
 tended beyond the disclaimed expiration date. Accord-
 ingly, in the absence of such disclaimers, it would frustrate
 the clear intent of Congress for applicants to benefit from
 their failure, or an examiner’s failure, to comply with es-
 tablished practice concerning ODP, which contemplates
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 IN RE: CELLECT, LLC                                         21

 terminal disclaimers as a solution to avoid invalidation of
 patents claiming obvious inventions, as we have here.
     We thus conclude that ODP for a patent that has re-
 ceived PTA, regardless whether or not a terminal dis-
 claimer is required or has been filed, must be based on the
 expiration date of the patent after PTA has been added.
 We therefore further conclude that the Board did not err in
 finding the asserted claims unpatentable under ODP.
                               II
     We next consider Cellect’s challenge to the Board’s de-
 termination that equitable concerns underlying ODP, in-
 cluding an improper timewise extension of a patent term
 and potential harassment by multiple assignees, are pre-
 sent in this case.
      Cellect argues that the equitable concerns underlying
 ODP, including an improper timewise extension of a patent
 term and potential harassment by multiple assignees, do
 not exist in this case. Cellect asserts that the Board cannot
 and does not point to any evidence that Cellect has pur-
 posely manipulated the system to delay the issuance of the
 challenged patents to improperly extend their term. Cel-
 lect further asserts that it has never and will never split its
 patents among multiple owners, and thus the risk of claim
 splitting or harassment by multiple litigants is entirely
 speculative. Cellect contends that the use of ODP to inval-
 idate related patents with shared expiration dates based
 on an alleged nonexistent risk of divided ownership is im-
 proper.
      The USPTO responds that the Board’s decision is
 properly grounded in the public policy surrounding ODP.
 The USPTO asserts that the Board did not err in determin-
 ing that Cellect received an unjustified timewise extension
 of its patent terms and that it does not matter how the un-
 justified extensions are obtained. The USPTO further as-
 serts that gamesmanship is not the only issue, and that the
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 22                                        IN RE: CELLECT, LLC

 mere presence of an unjustified extension is sufficient for
 the Board to find that claims are unpatentable under ODP.
 The USPTO further asserts that the Board did not err in
 determining that a risk of separate ownership existed
 (from, for example, creditors dividing the patents after a
 potential bankruptcy proceeding), or in determining that a
 terminal disclaimer would have been required to ensure
 continued common ownership even if the patents had the
 same expiration date. The USPTO also asserts that the
 Board did not err in finding Cellect’s declaration not to as-
 sign the patents insufficient.
     We agree with the USPTO that the Board did not err
 in determining that Cellect received unjustified extensions
 of patent term. Neither Cellect nor the USPTO disputes
 that the asserted claims in the challenged patents would
 have been obvious variations of the respective claims in the
 invalidating ODP references. The obviousness of the as-
 serted claims in each of the challenged patents can be
 traced back to the ’036 patent. That is the only patent in
 the family that did not receive a grant of PTA and that ex-
 pired on October 6, 2017, twenty years from the date on
 which the priority application was filed. Therefore, any ex-
 tension past that date constitutes an inappropriate time-
 wise extension for the asserted claims of the challenged
 patents. To hold otherwise would, in effect, confer on the
 reference claims of the ’036 patent PTA to which they were
 not entitled. We do, however, note that the non-asserted
 claims in the challenged patents are entitled to their full
 term, including the duly granted PTA, unless they are
 found to be later-filed obvious variations of earlier-filed,
 commonly owned claims. We have no basis for considera-
 tion of that issue here.
     We also agree with the USPTO that the Board did not
 err in determining that a risk of separate ownership ex-
 isted and, even in the absence of separate ownership, that
 a terminal disclaimer would have been required to ensure
 common ownership. As the Board found, the patents
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 IN RE: CELLECT, LLC                                        23

 expired fewer than six years ago, so the risk remains for
 multiple assignees to seek past damages. While Cellect
 has not engaged in actions that resulted in divided owner-
 ship in the past, and it has promised that it will not do so
 in the future, neither fact suffices to abrogate the potential
 future risk of multiple owners or assignees. Promises do
 not substitute for sound applications of rules of law.
      Cellect argues that, because it acted in good faith and
 because the grant of PTA takes into account any actions on
 the part of the applicant that may exacerbate the USPTO’s
 delay, 35 U.S.C. § 154(b)(2)(C), it should not lose out on the
 grant of extra term that is required by statute. But there
 is no basis for an examiner to inquire into the intent of an
 applicant, or credit it. The ability of the applicant to show
 good faith during prosecution does not entitle it to a patent
 term to which it otherwise is not entitled. An applicant’s
 ability to show that it did not engage in gamesmanship in
 obtaining a grant of PTA is not sufficient to overcome a
 finding that it has received an unjust timewise extension
 of term.
                              III
     We finally consider Cellect’s challenge to the Board’s
 determination that the ex parte reexamination proceedings
 raised a substantial new question of patentability.
     Cellect argues that there was no substantial new ques-
 tion of patentability present in the underlying reexamina-
 tions, so the reexaminations were improper. In particular,
 Cellect asserts that the same examiner analyzed all the
 challenged and reference patents, and was therefore aware
 of them, yet did not issue any ODP rejections during pros-
 ecution, despite issuing ODP rejections during the prose-
 cution of other Cellect-owned applications that he
 examined. Cellect asserts that the Board artificially cre-
 ated a substantial new question of patentability by second-
 guessing the examiner’s judgment.
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 24                                        IN RE: CELLECT, LLC

     Cellect further argues that, even if we affirm the
 Board’s holding that an ODP analysis for a patent that has
 received PTA is based on the expiration date including
 PTA, only the adjustment period, not the entire patent
 term, should be considered for invalidation.
     The USPTO responds that the Board correctly deter-
 mined that the reexamination requests raised a substan-
 tial new question of patentability because there is no
 indication that the examiner raised ODP as a relevant is-
 sue during the prosecution of the challenged patents. The
 USPTO further contends that the examiner’s knowledge of
 the reference patents and ODP rejection in other applica-
 tions is not sufficient to find that ODP was actually consid-
 ered and decided by the examiner during prosecution of the
 challenged patents.
     The USPTO also responds that Cellect’s request only
 to invalidate any granted adjustment period rather than
 the entire patent term was waived, as it was not raised be-
 fore the Board. Even if it was not waived, the USPTO as-
 serts that invalidating only the adjustment would be
 tantamount to issuing a retroactive terminal disclaimer,
 which would be improper.
      We agree with the USPTO that the Board’s determina-
 tion that the reexamination requests raised a substantial
 new question of patentability was supported by substantial
 evidence. Cellect’s arguments lack merit and amount to
 little more than attempting to prove a negative. The exam-
 iner’s willingness to issue ODP rejections of claims in other
 Cellect-owned patent applications but not in the chal-
 lenged patents and his knowledge of the reference patents
 do not affirmatively indicate that he considered ODP here.
 Further, “[t]he existence of a substantial new question of
 patentability is not precluded by the fact that a patent or
 printed publication was previously cited by or to the
 [USPTO] or considered by the [USPTO].” 35 U.S.C.
 § 303(a). And, as the Board notes, neither party points to
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 IN RE: CELLECT, LLC                                        25

 anything in the prosecution history that affirmatively indi-
 cates that the examiner considered whether or not an ODP
 rejection should be made. We thus conclude that the
 Board’s findings were supported by substantial evidence
 and that a substantial new question of patentability was
 present in the underlying ex parte reexaminations.
     A substantial new question of patentability requires
 just that—a substantial new question. Here, where Cellect
 itself does not indicate a single portion of the prosecution
 history explicitly showing that the examiner considered
 ODP, the threshold for showing a substantial new question
 has been met. The fact that this case is before us here with-
 out terminal disclaimers having been required itself
 strongly suggests that the examiner did not consider the
 issue.
      We also agree with the USPTO that the question of in-
 validation of only the adjustment period raised by Cellect
 on appeal is forfeited, as it was not raised before the Board.
 We further agree with the USPTO that, even if not for-
 feited, invalidation of only the adjustment would be tanta-
 mount to granting a retroactive terminal disclaimer, tying
 the expiration of the later-filed claims to the earlier-filed
 reference claims. A terminal disclaimer is not an escape
 hatch to be deployed after a patent expires. Cellect had the
 opportunity to file terminal disclaimers during prosecu-
 tion, even in the absence of an ODP rejection, yet it de-
 clined to do so. Now the challenged patents have expired,
 and the opportunity has passed. Invalidating only the ad-
 justed term would in effect give Cellect the opportunity to
 benefit from terminal disclaimers that it never filed.
                         CONCLUSION
      We have considered Cellect’s remaining arguments but
 find them unpersuasive. For the foregoing reasons, the de-
 cision of the Board is affirmed.
                         AFFIRMED