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 represented 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 Biotechnology 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, Washington, DC, for amicus curiae Pharmaceutical Research and 

Manufacturers of America. Also represented by STEVEN J.

HOROWITZ, Chicago, IL; DAVID EVAN KORN, Pharmaceutical 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 reexamination decisions of the United States Patent and Trademark 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 patent”); (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 reasons 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) comprising image sensors. The challenged patents are all interrelated, 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 prosecution 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, asserting 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 proceedings, the asserted claims and ODP invalidating reference patents are indicated in the table, with representative 

claims indicated in bold. 

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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 unpatentable 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 challenged patents to the Board. Cellect noted that under Novartis 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 negate 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, including (1) preventing the receipt of an improper timewise 

extension of a patent term, and (2) preventing split ownership of related patents and subsequent potential harassment by multiple owners or assignees. Cellect asserted 

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that no terminal disclaimer could be filed to cure the rejection since the patents had expired, but that it had promised 

not to sell its expired patents. That, Cellect contended, abrogated the risk of harassment by multiple owners or assignees. Cellect also argued that the ex parte

reexamination requests were not properly granted because 

the examiner had allegedly considered ODP during prosecution of the challenged patents, and so none of the requests presented a substantial new question of 

patentability, a requirement for a proper ex parte reexamination. 

In each of the four appeals from ex parte reexamination, the Board sustained the examiner’s determinations 

that the asserted claims of the challenged patents were unpatentable 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 compared 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 terminal 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 resulting 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 between ODP and PTE in the absence of a terminal disclaimer. 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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expiration date of the patent before the addition of PTE. 

Id. at 1373–74. 

In the four underlying appeals for ex parte reexamination, 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 doctrine (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 disclaimed 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 rejections, and so Congress, by addressing terminal disclaimers in § 154, effectively addresses ODP. JA. 37. The Board 

further reasoned that this court has stated that ODP “prevent[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 Kennedy 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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considered after any PTA. J.A. 38. That is, any ODP analysis 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 invalidating ODP references and noted that Cellect did not dispute 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 unjustified 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 assignees, remained active. J.A. 44–46. Finally, the Board 

found that ODP was a substantial new question of patentability 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 indication 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 applications, 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 jurisdiction 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. Second, 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 substantial new question of patentability in the underlying ex parte

reexaminations, and thus that the reexamination proceedings 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, unsupported by substantial evidence, or otherwise not in accordance 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 question of patentability exists is a question of fact that we review 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 evidence 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 determination 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 Patent and Trademark Office to— 

(i)–(iv) [providing for appropriate notifications 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 application pendency.—Subject to the limitations under 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 commencement of the national stage under section 

371 in the international application, not including— 

(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 appeals.—Subject to the limitations under paragraph (2), if the issue of an original patent is 

delayed due to— 

(i)–(iii) [providing for delay conditions related to derivation proceedings, secrecy orders, and appeals],

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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 disclaimed beyond a specified date may be adjusted 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 efforts to conclude prosecution of the application.

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 manufacturing 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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(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 regulatory 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 authorized extensions of term, Cellect contends that ODP cannot 

cut off PTA and that whether or not claims are unpatentable 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 similar statutory limitations. Cellect asserts that PTE is limited 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, pursuant 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 fundamentally change continuations practice. 

In addition, Cellect argues that legislative intent illustrates that PTE and PTA were meant to be mandatory 

term adjustment and extension provisions that restore patent term lost to different administrative delays. Cellect 

notes that each statutory provision states that the extension “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 Biotechnology Innovation Organization and Pharmaceutical Research 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, Cellect does not dispute that the challenged and reference patents are commonly owned, that the challenged patents 

expire after the reference patents, or that all challenged 

claims are patentably indistinct over claims in the reference patents. 

The USPTO further responds that statutory language 

and precedent clearly illustrate that PTA and PTE should 

be considered differently from each other when determining 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 consideration of ODP, see Novartis, 909 F.3d at 1375, an adjustment 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 related patents filed at the same time claim overlapping subject 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 cannot be viewed in a vacuum, and it is limited to the application 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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 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 terminal 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 required 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 differently from each other. The USPTO asserts that differential 

treatment was confirmed in Merck. 

The USPTO’s position is supported by amici representing Alvogen PB Research & Development LLP, the Association 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-expiring 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 unpatentable 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 expiration 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 provide statutorily authorized time extensions that restore patent 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 obtain “a patent” (i.e., a single patent) for an invention. In re 

Lonardo, 119 F.3d 960, 965 (Fed. Cir. 1997). ODP “is intended 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 claiming a second patent for claims that are not patentably distinct 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 rejection 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 terminal 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 patent or, at least, ties later-filed, commonly owned, obvious 

variations to the expiration date of an earlier-filed reference 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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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 terminal disclaimer was filed from the benefit of a term adjustment 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 expired 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 terminal disclaimers and ODP in the context of PTA. We extended 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 expiration 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 invalidated,” 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 terminal 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 another statutorily authorized extension, PTA, interacts with 

ODP. Even though both PTA and PTE are statutorily authorized 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 determined 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-authorized 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 designed to effectively extend the overall patent term for a 

single invention due to regulatory delays in product approval. 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 interpretation of the PTA statue would effectively extend the overall 

patent term awarded to a single invention contrary to Congress’s purpose by allowing patents subject to PTA to have 

a longer term than the reference patent. The USPTO’s approach merely recognizes the distinct purposes and interpretation of the two statutes. It does not allow a judgemade 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, under 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 different 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 requirements 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 disclaimer. 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 extended). 

In addition, while § 154(b)(2)(B)’s provision regarding

terminal disclaimers is not directly applicable to the present 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 [pursuant to 35 U.S.C. § 253] beyond a specified date may be adjusted under this section beyond the expiration date 

specified in the disclaimer.” Cellect had the opportunity to 

file terminal disclaimers in this case during both prosecution and ex parte reexamination. And, of course, the examiners 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 disclaimer 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 terminal disclaimer must include to be effective. 37 C.F.R. 

§ 1.321. In particular, the regulation provides that a patentee may disclaim any complete claim or claims in a patent, 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 overcome an ODP rejection, so terminal disclaimers and ODP 

remain inextricably intertwined. See Boehringer Ingelheim 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 tantamount 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 disclaimers had been filed in this case, the provisions of 

§ 154(b)(2)(B) would have come into play. Congress intended that, when a terminal disclaimer has been entered 

in a patent subject to PTA, no patent (or claim) may be extended beyond the disclaimed expiration date. Accordingly, 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 established 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 received PTA, regardless whether or not a terminal disclaimer 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 determination that equitable concerns underlying ODP, including an improper timewise extension of a patent term 

and potential harassment by multiple assignees, are present 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 purposely manipulated the system to delay the issuance of the 

challenged patents to improperly extend their term. Cellect 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 invalidate related patents with shared expiration dates based 

on an alleged nonexistent risk of divided ownership is improper. 

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 determining that Cellect received an unjustified timewise extension 

of its patent terms and that it does not matter how the unjustified extensions are obtained. The USPTO further asserts 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 assign 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 asserted 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 expired on October 6, 2017, twenty years from the date on 

which the priority application was filed. Therefore, any extension past that date constitutes an inappropriate timewise 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 consideration of that issue here.

We also agree with the USPTO that the Board did not 

err in determining that a risk of separate ownership existed 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 ownership 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 question of patentability present in the underlying reexaminations, 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 prosecution, despite issuing ODP rejections during the prosecution of other Cellect-owned applications that he 

examined. Cellect asserts that the Board artificially created a substantial new question of patentability by secondguessing 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 determined that the reexamination requests raised a substantial new question of patentability because there is no 

indication that the examiner raised ODP as a relevant issue 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 applications is not sufficient to find that ODP was actually considered 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 before the Board. Even if it was not waived, the USPTO asserts 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 determination 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 examiner’s willingness to issue ODP rejections of claims in other 

Cellect-owned patent applications but not in the challenged 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 indicates 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 without 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 invalidation 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 forfeited, invalidation of only the adjustment would be tantamount 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 prosecution, even in the absence of an ODP rejection, yet it declined to do so. Now the challenged patents have expired, 

and the opportunity has passed. Invalidating only the adjusted 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 decision of the Board is affirmed. 

AFFIRMED

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