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 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,
Case: 22-1293 Document: 91 Page: 2 Filed: 08/28/2023
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
Case: 22-1293 Document: 91 Page: 3 Filed: 08/28/2023
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.
Case: 22-1293 Document: 91 Page: 4 Filed: 08/28/2023
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.
Case: 22-1293 Document: 91 Page: 5 Filed: 08/28/2023
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 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
Case: 22-1293 Document: 91 Page: 6 Filed: 08/28/2023
6 IN RE: CELLECT, LLC
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
Case: 22-1293 Document: 91 Page: 7 Filed: 08/28/2023
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 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
Case: 22-1293 Document: 91 Page: 8 Filed: 08/28/2023
8 IN RE: CELLECT, LLC
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
Case: 22-1293 Document: 91 Page: 9 Filed: 08/28/2023
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
Case: 22-1293 Document: 91 Page: 10 Filed: 08/28/2023
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],
Case: 22-1293 Document: 91 Page: 11 Filed: 08/28/2023
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 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]
…
Case: 22-1293 Document: 91 Page: 12 Filed: 08/28/2023
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 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
Case: 22-1293 Document: 91 Page: 13 Filed: 08/28/2023
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
Case: 22-1293 Document: 91 Page: 14 Filed: 08/28/2023
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.
Case: 22-1293 Document: 91 Page: 15 Filed: 08/28/2023
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 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
Case: 22-1293 Document: 91 Page: 16 Filed: 08/28/2023
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
Case: 22-1293 Document: 91 Page: 17 Filed: 08/28/2023
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 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,
Case: 22-1293 Document: 91 Page: 18 Filed: 08/28/2023
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 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
Case: 22-1293 Document: 91 Page: 19 Filed: 08/28/2023
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.
Case: 22-1293 Document: 91 Page: 20 Filed: 08/28/2023
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
Case: 22-1293 Document: 91 Page: 21 Filed: 08/28/2023
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
Case: 22-1293 Document: 91 Page: 22 Filed: 08/28/2023
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 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 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
Case: 22-1293 Document: 91 Page: 23 Filed: 08/28/2023
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.
Case: 22-1293 Document: 91 Page: 24 Filed: 08/28/2023
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
Case: 22-1293 Document: 91 Page: 25 Filed: 08/28/2023
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
