Case: 22-1896 Document: 43 Page: 1 Filed: 12/13/2023
NOTE: This disposition is nonprecedential.
United States Court of Appeals
for the Federal Circuit
______________________
IN RE: INSTITUT PASTEUR,
Appellant
______________________
2022-1896
______________________
Appeal from the United States Patent and Trademark
Office, Patent Trial and Appeal Board in No. 14/730,396.
______________________
Decided: December 13, 2023
______________________
SALVATORE J. ARRIGO, III, Arrigo, Lee, Guttman &
Mouta-Bellum LLP, Washington, DC, argued for appel-
lant. Also represented by HARRY JOEL GUTTMAN.
KAKOLI CAPRIHAN, Office of the Solicitor, United States
Patent and Trademark Office, Alexandria, VA, argued for
appellee Katherine K. Vidal. Also represented by AMY J.
NELSON, MAUREEN DONOVAN QUELER, FARHEENA YASMEEN
RASHEED.
______________________
Before TARANTO, CLEVENGER, and STOLL, Circuit Judges.
CLEVENGER, Circuit Judge.
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2 IN RE: INSTITUT PASTEUR
Institut Pasteur (“Pasteur”) appeals from a decision of
the Patent Trial and Appeal Board (“Board”) affirming an
examiner’s rejection of claims 35–53 of U.S. Patent Appli-
cation No. 14/730,396 (“’396 Application”) for obviousness-
type double patenting. For the reasons set forth below, we
affirm.
BACKGROUND
Pasteur filed the ’396 Application on June 4, 2015. The
’396 Application relates to “peptides derived from human
Basic Proline-rich Lacrimal Protein (BPLP), notably
opiorphin.” ’396 Application, Abstract.
Following amendments during prosecution, an inde-
pendent Claim 17 for the ’396 Application recited:
17. A method for treating pain comprising admin-
istering a dose of 10-300 mg/day of a peptide con-
sisting of the sequence Gln-Arg-Phe-Ser-Arg (SEQ
ID NO:2) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO:55)
for 7 days.
J.A. 327.
The examiner rejected pending claims 17–29 on the
ground of obviousness-type double patenting over “claims
1, 3, 5, 6, 8, 10, 11 and 14 of
U.S. Patent No. 9,403,871.”
J.A. 234, 325.
U.S. Patent No. 9,403,871 (“’871 Patent”) was filed by
Pasteur on May 19, 2014, and is titled “Methods for treat-
ing pain by administering peptides derived from human
basic proline-rich lacrimal protein.” The ’871 Patent re-
lates to “diagnostic and therapeutic uses of human BPLP
protein, [and] peptides derived therefrom.” ’871 Patent,
col. 1, ll. 24–26. Claim 1 and 6 of the ’871 Patent recite:
1. A method for treating pain comprising adminis-
tering an effective amount of an isolated peptide
consisting of up to 15 amino acids to a human sub-
ject,
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IN RE: INSTITUT PASTEUR 3
wherein the peptide comprises the se-
quence Glu-Arg-Phe-Ser-Arg (SEQ ID NO:
3) or Glp-Arg-Phe-Ser-Arg (SEQ ID NO: 7),
wherein the peptide exhibits an inhibitory
property against a neutral endopeptidase
or an aminopeptidase and
wherein the peptide has the same amino
acid sequence as that found within human
Basic Proline-rich Lacrimal Protein (SEQ
ID NO:2) or differs from the amino acid se-
quence found within SEQ ID NO:2 by two
or less amino acid substitutions.
...
6. The method of claim 1, comprising administering
a dose of 10-100 mg of the peptide.
’871 Patent, col. 41, l. 27–col. 42, l. 27. 1
In the rejection based on the ’871 Patent, the examiner
explained that it would have been “obvious for one of ordi-
nary skill in the art to treat chronic pain by the methods of
claims 1, 3, 5, 6, 8, 10, 11 and 14 of
U.S. Patent No.
9,403,871, which would require treatment for several days,
7 included.” J.A. 234.
Pasteur appealed the obviousness-type double patent-
ing rejection to the Board. The Board affirmed and agreed
with the examiner that “the ’871 patent’s claim term ‘pain’
. . . includes at least ‘acute pain’ and ‘chronic inflammatory
pain such as arthritis or inflammatory bowel disease.’” Ex
Parte Rougeot, No. 2018-007103,
2019 WL 6208056, at *5
(P.T.A.B. Oct. 4, 2019) (“First Decision”) (quoting ’871 Pa-
tent, col. 18, ll. 15–17). The Board also found that the ’871
1 A certificate of correction replaced “Glu” with “Gln”
in Claim 1 of the ’871 Patent.
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4 IN RE: INSTITUT PASTEUR
Patent’s claim term “‘effective amount of an isolated pep-
tide’ includes within its scope . . . a therapeutic mixture in-
cluding about 0.0001 to 100 milligrams of the peptide, or,
most preferably, 10–100 milligrams per dose, and that
‘[m]ultiple doses can be administered.’”
Id. (quoting ’871
Patent, col. 16, ll. 49–57).
In evaluating the “7 days” limitation, the Board consid-
ered “the type of pain disclosed and claimed as being
treated in the ’871 patent [to] include[] chronic pain, which
by its very persisting or reoccurring nature may last sev-
eral days.”
Id. The Board then concluded that “one of or-
dinary skill in the art would have found it obvious to treat
such pain for 7 days (and more) because of its persistent
nature.”
Id. The Board also agreed with the reasoning of
the examiner that “‘[i]t is reasonable to interpret that
treatment “administering a dose of 10-100 mg of the pep-
tide” occurs at intervals necessary to alleviate pain, start-
ing with daily administration’ and if pain persists,
chronically, to a second day, treatment should likewise ex-
tend to the second day, and so on to the claimed 7 days (or
beyond).”
Id.
After the First Decision, Pasteur filed a Request for
Continued Examination to modify the independent claim
to recite:
17. [] A method for treating pain in a human pa-
tient comprising administering a dose of 1 mg/kg to
2mg/kg at 10-300 mg/day of a peptide consisting of
the sequence Gln-Arg-Phe-Ser-Arg (SEQ ID NO:2)
or Glp-Arg-Phe-Ser-Arg (SEQ ID NO:55) to the pa-
tient for 7 days without inducing pharmacodepend-
ence or tolerance in the patient.
J.A. 335. This claim was later renumbered to be Claim 35
and is representative for the purposes of this appeal. J.A.
371.
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IN RE: INSTITUT PASTEUR 5
The examiner again rejected the amended claims based
on obviousness-type double patenting because of the ’871
Patent. The examiner noted Pasteur’s argument regarding
the difference in dosages and duration of treatment re-
flected by the claim language of claims 1 and 6 of the ’871
Patent and claim 17 of the ’396 Application, and responded
that Pasteur’s argument has been fully considered and an-
swered in the previous rejection, which had been affirmed
by the Board and not appealed to this court. J.A. 385–86.
With respect to the “1 mg/kg to 2 mg/kg” addition, the ex-
aminer explained “that 1 mg/kg to 2 mg/kg per day equals
to 80 mg to 160 mg per day[ for the] average weight of 80
kg.” J.A. 383. The examiner also explained that adding
“without inducing pharmacodependence or tolerance in the
patient” did not create patentability because “[t]he discov-
ery of a previously unappreciated property of a prior art
composition, or of a scientific explanation for the prior art’s
functioning, does not render the old composition patenta-
bly new to the discoverer.” J.A. 383–84 (quoting Atlas Pow-
der Co. v. Ireco, Inc.,
190 F.3d 1342, 1347 (Fed. Cir. 1999)).
After the Non-Final Rejection on the amended claims,
Pasteur filed a Declaration from Catherine Rougeot. Ms.
Rougeot is a “visiting researcher” at Pasteur and is also the
named inventor on the ’396 Application. J.A. 19, 444. Ms.
Rougeot declared that “opioid receptor agonists, such as
morphine” are the “most efficient drugs to alleviate severe
pain” but their “clinical usefulness has been limited by the
development of tolerance and dependence that occurs after
long-term treatment.” J.A. 446 ¶¶ 15–16.
Ms. Rougeot also declared that “[i]t was known in 2008
that human opiorphin at systemically equi-analgesic mor-
phine doses (1-2 mg/kg, i.v.) inhibits nociception in stand-
ard morphine-sensitive pain models.” J.A. 447 ¶ 23.
Further, Ms. Rougeot declared that “it was expected that
opiorphin could induce tolerance and dependence – just as
morphine does” and “opiorphin’s lack of the detrimental
side effects of opioids – tolerance and dependence – was
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6 IN RE: INSTITUT PASTEUR
surprising and unexpected.” J.A. 448 ¶ 25, 449 ¶ 36. Ms.
Rougeot also declared that “opiorphin fulfils a long-felt
need for efficient pain-controlling compounds without the
detrimental side effects of opioids – tolerance and depend-
ence.” J.A. 449 ¶ 35.
The examiner again rejected the amended claims. In
addressing the Rougeot Declaration, the examiner noted
that the “Declaration states that administration of 1-2
mg/kg of opiorphin to alleviate pain was known, and . . .
[the Declaration] contemplates that the expected physio-
logical mechanism of action of opiorphin would prohibit its
use over extended period, such as for 7 days or 11 days.”
J.A. 479. The examiner then recognized that the “Declar-
ant explains . . . that the further research found opirphin
[sic] to have a minimal adverse morphine-associated effect
and to produce analgesic potency, and concludes that this
effect was surprising and unexpected.” J.A. 479.
The examiner found that the arguments presented in
the Rougeot Declaration were not persuasive. The exam-
iner explained that “the Declaration acknowledges that the
instant method of treatment of pain uses the same drug
and the same dose as taught by the ’871 patent,” and so
“[t]he only remaining disputed difference between the
scope of the instant claims and the claims of the ’871 patent
is the duration of the treatment.” J.A. 479. The examiner
explained that this issue was previously before the Board
and that “the treatment of pain of the ’871 patented claims
encompasses treatment of chronic pain . . . even if the full
understanding of the mechanism of pharmacopedendence
[sic] of the drug was not appreciated at the time.” J.A. 479–
80. The examiner decided that “Applicant’s further re-
search of the subject matter and discovering new proper-
ties of opiorphin does not render the instant claims
patentable.” J.A. 480.
The examiner next addressed Pasteur’s arguments re-
garding objective indicia of nonobviousness. The examiner
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IN RE: INSTITUT PASTEUR 7
said that the claims were “not patentably distinct from the
invention claimed in the
U.S. Patent No. 9,403,871 because
it encompasses [an] identical process of administering the
same drug to treat the same pathology, which is expected
to produce identical results.” J.A. 481. The examiner
added that “all the adjustments – dose to be administered
as well as daily dose, [and] treatment for 7 days or longer
. . . – represent a finite number of identified, predictable
solutions, and one of ordinary skill in the art would have
recognized that the results of this adjustment are predict-
able.” J.A. 481. The examiner concluded that “the results
of practicing the treatment regime are reasonably expected
to produce identical effect, absent evidence to the con-
trary.” J.A. 481.
Pasteur again appealed the rejection to the Board. In
an oral hearing, the Administrative Patent Judge and Pas-
teur had the following exchange regarding the disputed re-
jection:
JUDGE FLAX: So it’s -- I think that we all
agree that it’s reciting the same peptide that is the
therapeutic compound of the present claims. I
think that we’re all --
MR. ARRIGO: Yes. That is correct.
JUDGE FLAX: -- we all agree on that. And I
think that we all agree that it’s disclosing a dose of
10 to 100 milligrams, which is within that claimed
range. And so the new thing that I think you’re ar-
guing is that claimed result if you use it for seven
days, you don’t get the dependence and you don’t
build up a tolerance.
MR. ARRIGO: Right.
J.A. 575–76.
In the Board’s decision regarding the amended claims,
the Board again affirmed the examiner and adopted the
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8 IN RE: INSTITUT PASTEUR
examiner’s findings of fact. The Board cited its First Deci-
sion and repeated its conclusion that “the ’871 patent’s
claims embrace treating chronic pain.” Ex Parte Rougeot,
No. 2021-005009,
2022 WL 1199280, at *4 (P.T.A.B. Apr.
12, 2022) (“Second Decision”). In addressing the Pasteur’s
arguments with respect to the “without inducing pharma-
codependence or tolerance in the patient,” the Board first
reiterated that “there is no dispute here that the ’871 pa-
tent’s claims teach treating chronic pain with the same
drug, at the same dose, for the same duration as presently
claimed.”
Id. at *6. The Board then said it was not per-
suaded by Pasteur’s arguments based on the Rougeot Dec-
laration and held that “[t]he fact that performing this prior
art method would produce a result, surprising or not, that
the treated patient would not experience tolerance or phar-
macodependence is, as in Baxter, mere recognition of a la-
tent property in an obvious method of treating pain with
the same peptide.”
Id. (citing In re Baxter Travenol Labs.,
952 F.2d 388, 392 (Fed. Cir. 1991)). The Board also rejected
the argument regarding a long-felt need for a “morphine
replacement that does not share morphine’s potential for
tolerance and pharmacodependence, [because] this need
would have been satisfied by the subject matter claimed in
the ’871 Patent, which precedes the present claims.” Id. at
*7.
Pasteur timely appealed the Board’s Second Decision,
and we have jurisdiction under
28 U.S.C. § 1295(a)(4)(A).
DISCUSSION
The ultimate determination of whether an invention
would have been obvious under
35 U.S.C. § 103(a) is a legal
conclusion based on underlying findings of fact. In re
Kotzab,
217 F.3d 1365, 1369 (Fed. Cir. 2000). Therefore,
the Board’s ultimate determination of obviousness is re-
viewed without deference, and the Board’s underlying fac-
tual findings are reviewed for substantial evidence. Id.;
PersonalWeb Techs., LLC v. Apple, Inc.,
917 F.3d 1376,
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IN RE: INSTITUT PASTEUR 9
1381 (Fed. Cir. 2019). The underlying factual findings in-
clude “objective indicia of nonobviousness.” Ariosa Diag-
nostics v. Verinata Health, Inc.,
805 F.3d 1359, 1364 (Fed.
Cir. 2015). Additionally, “[t]he inherent teaching of a prior
art reference is a question of fact.” Par Pharm., Inc. v. TWI
Pharms., Inc.,
773 F.3d 1186, 1194 (Fed. Cir. 2014) (cita-
tion omitted).
On appeal, Pasteur challenges the Board’s obviousness
analysis. Pasteur argues that the Board did not have sub-
stantial evidence for its factual determinations and that
parts of the Second Decision erred as a matter of law.
PRIMA FACIE OBVIOUSNESS
Pasteur argues that the Board disregarded differences
between the claims of the ’871 Patent and the dose and du-
ration limitations of the ’396 Application. However, in its
obviousness analysis in the Second Decision, the Board
cited its First Decision which had previously addressed
how these limitations were obvious in light of the claims of
the ’871 Patent. 2 Second Decision,
2022 WL 1199280, at
*4. The Board also reiterated how the examiner and its
First Decision explained that the “7 days” limitation was
obvious because the ’871 Patent’s claims “embrace[d] treat-
ing chronic pain [and] it would have been obvious to admin-
ister the therapy for seven days (which is the length of time
recited in appealed claim 35), as chronic pain may endure
for such a time.”
Id. Additionally, the Board explained
that the “1 mg/kg to 2mg/kg at 10-300 mg/day” limitation
would be obvious in light of claim 8 of the ’871 Patent which
claims “a dose of 10-100 mg of the peptide.”
Id. at *5.
The record shows that the Board had substantial evi-
dence for the conclusions regarding the dose and duration
limitations in light of the ’871 Patent. The Board’s findings
2 Pasteur did not appeal the First Decision of the
Board to this court.
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10 IN RE: INSTITUT PASTEUR
are reinforced by Pasteur’s concessions at its oral hearing
before the Board that the ’871 Patent disclosed the “same
peptide” and “a dose of 10 to 100 milligrams, which is
within that claimed range” of the ’396 Application and that
the “new thing” Pasteur was arguing was “that claimed re-
sult if you use it for seven days, you don’t get the depend-
ence and you don’t build up a tolerance.” J.A. 575–76.
Pasteur also challenges the Board’s determination re-
garding the “without inducing pharmacodependence or tol-
erance in the patient” limitation. After finding all other
limitations obvious in light of the ’871 Patent, the Board
adopted the examiner’s finding that the ’871 Patent “en-
compasse[d an] identical process of administering the same
drug to treat the same pathology, which is expected to pro-
duce identical results.” Second Decision,
2022 WL
1199280, at *5. The Board determined that “[t]he fact that
performing this prior art method would produce a result
. . . is . . . mere recognition of a latent property in an obvi-
ous method of treating pain with the same peptide.”
Id. at
*6 (citing In re Cruciferous Sprout Litig.,
301 F.3d 1343,
1349 (Fed. Cir. 2002)).
The Board had substantial evidence with respect to its
finding regarding the “without inducing pharmacodepend-
ence or tolerance in the patient” limitation. Pasteur has
not shown that this limitation would not be inherent when
practicing the prior art method of the ’871 Patent as de-
scribed by the Board.
Pasteur also argues that the Board misapplied the law
in its prima facie obviousness analysis. We disagree. In
contrast to Pasteur’s characterization, the Board did not
merely find that ’871 Patent claims “dominat[ed]” the ’396
Application but instead explained why each claim limita-
tion was obvious in light of the ’871 Patent claims. The
Board also did not err with respect to its use of inherency
in its obviousness analysis. It is settled that inherency may
supply a missing claim limitation in an obviousness
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IN RE: INSTITUT PASTEUR 11
analysis. See Hospira, Inc. v. Fresenius Kabi USA, LLC,
946 F.3d 1322, 1332 (Fed. Cir. 2020).
OBJECTIVE INDICIA OF NONOBVIOUSNESS
The Board also had substantial evidence regarding its
determinations related to the objective indicia of nonobvi-
ousness. Pasteur argues that the Board “improperly dis-
missed” the objective indicia evidence presented in the
Rougeot Declaration. While Pasteur provided some evi-
dence of the expectations of a skilled artisan based on the
effect of a similar treatment using morphine, the Board did
not find this evidence sufficient to overcome the prima facie
case of obviousness. The Board had substantial evidence
for this finding as Pasteur did not prove that the claimed
benefits are unexpected as compared to the closest prior
art. See Baxter,
952 F.2d at 392 (“[W]hen unexpected re-
sults are used as evidence of nonobviousness, the results
must be shown to be unexpected compared with the closest
prior art.”).
Pasteur also argues that the Board’s handling of unex-
pectedness erred as a matter of law under Honeywell Int’l
Inc. v. Mexichem Amanco Holding S.A. DE C.V.,
865 F.3d
1348, 1355 (Fed. Cir. 2017). However, we clarified in Cou-
varas that “Honeywell held that ‘unexpected properties
may cause what may appear to be an obvious composition
to be nonobvious,’ not that unexpected mechanisms of ac-
tion must be found to make the known use of known com-
pounds nonobvious.” See In re Couvaras,
70 F.4th 1374,
1380 (Fed. Cir. 2023) (quoting Honeywell, 865 F.3d at
1355). Similarly, Honeywell does not necessitate a finding
of nonobviousness here simply because one limitation was
found satisfied through inherency.
Pasteur also disagrees with the Board’s handling of the
Rougeot Declaration with respect to long-felt need. The
Board rejected the argument regarding a long-felt need for
a “morphine replacement that does not share morphine’s
potential for tolerance and pharmacodependence,
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12 IN RE: INSTITUT PASTEUR
[because] this need would have been satisfied by the sub-
ject matter claimed in the ’871 patent, which precedes the
present claims.” Second Decision,
2022 WL 1199280, at *7.
This factual conclusion is supported by the substantial ev-
idence for similar reasons as above.
CONCLUSION
After full review of the record and Pasteur’s argu-
ments, we conclude that the Board’s Decision was sup-
ported by substantial evidence and that Pasteur has not
identified any incorrect legal conclusions by the Board.
AFFIRMED
