Najib Babul et al.

Patent Trials and Appeals Board

Jul 25, 2019

12988209 - (D) (P.T.A.B. Jul. 25, 2019)

UNITED STATES PATENT AND TRADEMARK OFFICE
UNITED STATES DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
Address: COMMISSIONER FOR PATENTS
P.O. Box 1450
Alexandria, Virginia 22313-1450
www.uspto.gov
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO.
12/988,209 10/15/2010 Najib Babul RELM-15US 8483
26875 7590 07/25/2019
WOOD, HERRON & EVANS, LLP
2700 CAREW TOWER
441 VINE STREET
CINCINNATI, OH 45202
EXAMINER
MATTISON, LORI K
ART UNIT PAPER NUMBER
1619
NOTIFICATION DATE DELIVERY MODE
07/25/2019 ELECTRONIC
Please find below and/or attached an Office communication concerning this application or proceeding.
The time period for reply, if any, is set in the attached communication.
Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the
following e-mail address(es):
usptodock@whe-law.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
________________

Ex parte NAJIB BABUL and ASHISH KUMAR REHNI1
________________

Appeal 2018-002363
Application 12/988,209
Technology Center 1600
________________

Before RICHARD M. LEBOVITZ, ERICA A. FRANKLIN,
and JOHN G. NEW, Administrative Patent Judges.

NEW, Administrative Patent Judge.

DECISION ON APPEAL

1 Appellants identify Relmada Therapeutics, Inc., as the real party-in-
interest. App. Br. 1.
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Application 12/988,209

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SUMMARY
Appellants file this appeal under 35 U.S.C. § 134(a) from the
Examiner’s Final Rejection of claims 199–207 and 209–213 as unpatentable
under 35 U.S.C. § 112, first paragraph, for failing to meet the written
description requirement by the introduction of new matter.
Claims 199 and 204 also stand rejected as unpatentable under 35
U.S.C. § 112, second paragraph, as being indefinite.
Claims 199–207 and 209–213 stand further rejected as unpatentable
under 35 U.S.C. 102(b) as being anticipated by Oshlack et al. (US 7,144,587
B2, December 5, 2006) (“Oshlack”).
Claims 199–202, 205, 206, 209, 210, 212, and 213 stand provisionally
rejected as unpatentable under the judicially-created doctrine of
obviousness-type double patenting as being unpatentable over claims 81,
187, and 191 of copending US Ser. No. 12/223,327 (the “’327 application),
filed October 28, 2014.2
We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

2 Appellants fail to acknowledge or address the rejection of the claims on
this ground in either their Appeal or Reply Brief. We therefore summarily
affirm the Examiner’s provisional rejection. See 37 C.F.R. § 41.37(c)(iv)
(“[A]ny arguments or authorities not included in the appeal brief will be
refused consideration by the Board for purposes of the present appeal”).
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NATURE OF THE CLAIMED INVENTION
Appellants’ invention is directed to oral pharmaceutical compositions
of buprenorphine and its pharmaceutically acceptable salts and the use
thereof. Abstract.

REPRESENTATIVE CLAIM
Claim 199 is representative of the claims on appeal and recites:
199. A pharmaceutical composition for oral administration to a
human having a buprenorphine responsive medical condition,
the composition comprising a first portion in which

a therapeutically effective amount of buprenorphine

is combined with

a sufficient amount of at least one controlled release
material that not more than about 50% by weight of
buprenorphine is released from the first portion after one
hour when the composition is assessed by the USP Basket
Method at 100 rpm in 700 ml of Simulated Gastric Fluid
at 37°C.

App. Br. 17, Claims App’x.

ISSUES AND ANALYSES
We decline to adopt the Examiner’s findings, reasoning, and
conclusions relating to the rejection of the claims for lack of written
descriptive support and as being indefinite. However, we adopt the
Examiner’s findings, reasoning, and conclusion relating to the rejection of
the claims as anticipated by cited prior art. We address the arguments raised
by Appellants in the following analyses.
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A. Rejection of claims 199–207 and 209–213 as adding new material
Issue
Appellants argues that the Examiner erred in concluding that the
limitation of claim 199 reciting:
[A] sufficient amount of at least one controlled release material
that not more than about 50% by weight of buprenorphine is
released from the first portion after one hour when the
composition is assessed by the USP Basket Method at 100 rpm
in 700 ml of Simulated Gastric Fluid at 37°C

constitutes new matter not supported by Appellants’ Specification. App. Br.
6.

Analysis
The Examiner finds that there is no disclosure by Appellants’
Specification of a sufficient amount, or any amount, of a controlled release
material (“CRM”) to be combined with the “therapeutically effective amount
of buprenorphine,” such that “not more than about 50% by weight of
buprenorphine is released from the first portion…” The Examiner therefore
concludes that the claim, as amended by Appellants, changes the scope of
the disclosure, thereby constituting new matter. Final Act. 3–4.
Appellants argue that their Specification expressly discloses that the
preparation of oral controlled release pharmaceutical dosage forms is well
known and described in the art, and that the Specification discloses and
incorporates by reference over 200 prior art sources describing examples of
controlled release preparations. App. Br. 6 (citing e.g., Spec. ¶¶ 586–587).
Similarly, Appellants argue, the specified release characteristic recited in
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claim 199 is expressly disclosed in the Specification at paragraphs [0403]
and [0329]. Id.
Specifically, Appellants point to their Specification as:
1. Disclosing that controlled-release formulations of at least some
opioids other than buprenorphine are known (citing ¶¶ 7–8, 15).

2. Instructing skilled artisans to combine buprenorphine with one or
more CRMs (citing ¶¶ 136–139, 152–154, 287).

3. Specifying multiple known forms for drug-CRM combinations (citing
¶¶ 586–589).

4. Citing hundreds of examples of known CRMs and combinations
(citing ¶¶ 155–156, 586–587, 590–599, 604–610, 673–690).

5. Disclosing how to make buprenorphine-CRM combinations in many
known orally-administrable forms (citing ¶¶ 136–139, 152–154, 157–
159, 614–618, 621–636, 642–645, 656, 667–668, 672).

6. Identifying the assay conditions and release characteristics for
assessing whether any particular buprenorphine-CRM combination
satisfies the Specified Release Characteristic recited in claim 199
(¶¶ 329, 403).

7. Providing at least two dozen specific examples of particular BUP-
CRM combinations in the form of pharmaceutical compositions for
oral administration (Examples 1–24).

8 Confirming that skilled artisans know how to combine this
information in known ways to make and use the claimed
pharmaceutical compositions for oral administration (¶¶ 589, 604,
623, 629, 631, 639, 647, 649, 766–769).

App. Br. 6–7.
Appellants assert that a skilled artisan, having read Appellants’
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Specification, would understand Appellants’ use of a combination of
buprenorphine and a CRM to effectively administer buprenorphine in an oral
pharmaceutical composition by combining buprenorphine with “a sufficient
amount” of one or more CRMs to satisfy the specified release characteristic
recited in the claims. App. Br. 7. Appellants contend that nothing more
would be required for a person of ordinary skill to recognize that Appellants’
Specification discloses numerous compositions, including buprenorphine
and CRM, that exhibit the specified release characteristic on the basis of the
amount of CRM included therein. Id.
The Examiner acknowledges that paragraph [0590] of Appellants’
Specification discloses suitable controlled release materials, including
hydrophilic and/or hydrophobic materials, such as gums cellulose ethers,
acrylic resins, protein derived materials, waxes, shellac, oils, and non-
polymeric, non-water soluble liquids carbohydrate-based substances, or
poorly water soluble high melting point waxes. Ans. 4. However, the
Examiner finds that the Specification fails to disclose an amount for these
CRMs such that: “not more than about 50% by weight of buprenorphine is
released ... [when] assessed by the USP basket method.” Id. Therefore, the
Examiner finds, the Specification fails to adequately describe the genus
consisting of: “a sufficient amount of at least one controlled release material
that not more than about 50% by weight of buprenorphine is released ...
[when] assessed by the USP basket method.” Id.
The Examiner notes that, to provide evidence of possession of a
claimed genus, the Specification must provide sufficient distinguishing
identifying characteristics of the genus, including disclosure of complete or
partial structure, physical and/or chemical properties, functional
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characteristics, structure/function correlation, methods of making the
claimed product, or any combination thereof. Id. The Examiner concludes
that, in the absence of sufficient recitation of distinguishing identifying
characteristics, a person of ordinary skill in the art could not structurally
visualize the claimed genus. Id. at 4–5.
We are persuaded by Appellants’ arguments. The limitation reciting:
[A] sufficient amount of at least one controlled release material
that not more than about 50% by weight of buprenorphine is
released from the first portion after one hour when the
composition is assessed by the USP Basket Method at 100 rpm
in 700 ml of Simulated Gastric Fluid at 37°C

is a functional limitation that prescribes the “sufficient amount” of a given
CRM by the maximum amount of buprenorphine released after a single
hour, as measured by a standard assay. Paragraph [0239] of Appellants’
Specification discloses this functional requirement:
In some preferred embodiments, the oral dosage form of the
invention provides an in-vitro release of from about 2% to about
50% by weight of the buprenorphine or a pharmaceutically
acceptable salt of buprenorphine from the dosage form at one
hour when measured by the USP Basket Method at 100 rpm in
700 ml of Simulated Gastric Fluid (SGF) at 37 °C.

In analyzing whether the written description requirement of the first
paragraph of Section 112 has been met: “the test for sufficiency is whether
the disclosure of the application relied upon reasonably conveys to those
skilled in the art that the inventor had possession of the claimed subject
matter as of the filing date.” Ariad Pharms., Inc. v. Eli Lilly and Co., 598
F.3d 1336, 1351 (Fed. Cir. 2010). However:
The patent specification is written for a person of skill in the art,
and such a person comes to the patent with the knowledge of
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what has come before. Placed in that context, it is unnecessary to
spell out every detail of the invention in the specification; only
enough must be included to convince a person of skill in the art
that the inventor possessed the invention and to enable such a
person to make and use the invention without undue
experimentation.

LizardTech, Inc. v. Earth Resource Mapping, PTY, Inc., 424 F.3d 1336,
1345 (Fed. Cir. 2005)
Appellants’ Specification discloses sufficient members of the genus of
CRMs to inform a person of ordinary skill in the art of the scope of the
claimed genus. See Spec. ¶ 590. Appellants’ Specification discloses that the
art of using CRMs to control the rate of release of an active agent, in opioids
and in other pharmaceuticals, is very well known in the art: Appellants assert
that the Specification incorporates more than two hundred prior art
references detailing the use of such CRMs in the pharmaceutical arts. See,
e.g., Spec. ¶¶ 586–587. The Examiner does not dispute that contention.
The Examiner’s requirement that the Specification must disclose
“sufficient distinguishing identifying characteristics of the genus” is
misplaced in this case because the genus of materials was well known in the
time of the invention as established by Appellants and in the Specification.
Therefore, the skilled worker would have understood that the inventors had
possession of the claimed genus of materials.
With respect to the claimed “sufficient amounts” of the CRM, the
Specification, as discussed by Appellants, repeatedly refer to the controlled
release material which determines how much the buprenorphine is released.
See, e.g., Spec. ¶¶ 184, 188, 191, 195, 197, 199, 201, etc. The term
“sufficient amounts” is also used in the Specification to indicate that the
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amounts of the CRM must be adequate to achieve the desired release rate.
Spec.. e.g., ¶¶ 629, 654. Thus, one of ordinary skill in the art would have
recognized that the inventor had full possession of the recited functional
characteristic. Given that Appellants’ Specification discloses that use of
CRMs was very well known in the pharmaceutical arts, we agree with
Appellants that a person of ordinary skill would have realized that the
amount of a given CRM, such as those disclosed by the Specification,
required to meet the specific functional release requirements recited in the
claims was in the possession of the inventors at the time of filing. We
consequently reverse the Examiner’s rejection of the claims on this ground.

B. Rejection of claims 199 and 204 as indefinite
Issue
Appellants argue the Examiner erred in finding that the limitation of
claim 1 reciting: “a sufficient amount of at least one controlled release
material that not more than 50% by weight of buprenorphine is released
from the first portion after one hour” is indefinite. App. Br. 8.

Analysis
The Examiner finds that it is unclear what amount of the controlled
release polymer is a “a sufficient amount,” because the claim term
“sufficient amount” is not defined by the claim, the Specification does not
provide a standard for ascertaining the requisite degree, and one of ordinary
skill in the art would not be reasonably apprised of the invention. Final Act.
5. The Examiner concludes that because the metes and bounds of the claim
cannot be determined, the claim is indefinite. Id.
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Appellants argue that a person of ordinary skill in the art, reading
claim 199, would understand that the claim term “a sufficient amount” is a
functional limitation, the function being to control release of buprenorphine
from the claimed composition to a rate at or below that specified in the
claim. App. Br. 10. Appellants contend that proper analysis of this
functional limitation must consider whether a skilled artisan would
understand the metes and bounds of this functional limitation. Id.
Appellants contend that the specified release characteristic recited in
the claim is a definite, readily discernible limitation that can be assessed by a
definite, readily discernible (i.e., expressly disclosed) assay method. App.
Br. 10. Therefore, Appellants argue, the only question at issue is whether
recitation of “a sufficient amount” of a CRM to yield the specified release
characteristic renders claim 199 indefinite. Id. Appellants point out that
their Specification discloses (and the Examiner does not dispute) that CRMs
are well known in the art and serve the function of controlling that rate of
release of a drug from a dosage form. Id. Appellants also note that the
Specification also discloses hundreds, if not thousands, of examples of
CRMs and of compositions including CRMs to control release of
buprenorphine or another drug. Id.
Appellants assert that, throughout their Specification, it is emphasized
that numerous CRMs can be used to control, sustain, modify, delay and/or
extend the release of buprenorphine from the claimed compositions and
thereby achieve the Specified Release Characteristic – just as they have been
used in the prior art for other drug-containing compositions. App. Br. 11.
Appellants assert that a skilled artisan would understand from the
Specification that CRMs are a diverse group of known compound and can be
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formulated in multiple combinations and configurations. Id. Appellants
also contend that a person of ordinary skill would understand that a single
amount of CRM cannot be specified for the diverse range of CRMs
disclosed by the Specification that will define the threshold at which the
recited specified release characteristic will be exhibited by the claimed
composition. Id.
Appellants contend that Examiner has cited no reason why a person of
ordinary skill in the art would be unable to readily determine the amount of
any CRM (or combination or configuration of CRM(s)) that would be
sufficient to achieve the recited release characteristics to the composition.
App. Br. 11. Therefore, argue Appellants, the disputed limitation recited in
claim 199 must fairly be considered to convey to a skilled artisan that the
claim encompasses any of the CRMs that yield the specified buprenorphine-
release rate under the recited specified assay conditions. Id.
We are persuaded by Appellants’ arguments. As we have explained
supra, Appellants’ Specification documents and discloses that activity of
CRMs is very well understood in the pharmaceutical arts. See, e.g., Spec.
¶¶ 586–587. We agree with Appellants that the disputed limitation is a
functional limitation because it defines the requisite amount of a given CRM
by what it does, i.e., “that not more than about 50% by weight of
buprenorphine is released from the first portion after one hour when the
composition is assessed by the USP Basket Method at 100 rpm in 700 ml of
Simulated Gastric Fluid at 37°C.” Furthermore, the limitation provides a
sufficiently specific criterion for release: “not more than about 50% by
weight of buprenorphine is released from the first portion after one hour,”
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when measured by a standard assay, i.e., “the USP Basket Method at 100
rpm in 700 ml of Simulated Gastric Fluid at 37°C.”
“A patent is invalid for indefiniteness if its claims, read in light of the
patent's specification and prosecution history, fail to inform, with reasonable
certainty, those skilled in the art about the scope of the invention.” Nautilus,
Inc. v. Biosig Instruments, Inc., 572 U.S. 898, 898–99 (2014). Definiteness
is to be evaluated from the perspective of a person skilled in the relevant art,
claims are to be read in light of the patent’s specification and prosecution
history, and that definiteness is to be measured as of the time of the patent
application. Nautilus, 572 U.S. at 899.
We agree with Appellants that, given the knowledge of a person of
ordinary skill and knowledge in the art, the scope of the disputed limitation
would be able to discernible because: (1) the methods of using CRMs are
well understood in the art; (2) the limitation requires a specific, well-defined
release rate; and (3) the assay used to determine that release rate is expressly
recited in claim 199 and is recognized in the art as a standard assay. See
Spec. ¶ 292 (“…when measured in-vitro using the USP Basket … Method of
USP Drug Release test of U.S. Pharmacopeia (2003) at 100 rpm in 900 ml
aqueous buffer”).
Consequently, we conclude that the limitation of claim 199 reciting:
“a sufficient amount of at least one controlled release material that not more
than 50% by weight of buprenorphine is released from the first portion after
one hour” is not indefinite, and we reverse the Examiner’s rejection of the
claim.

C. Rejection of claims 199–207 and 209–213 as anticipated by Oshlack
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Issue
Appellants argue that the Examiner erred in finding that Oshlack
discloses the term “pharmaceutical composition for oral administration”
recited in claim 199. App. Br. 15.

Analysis
The Examiner finds that Oshlack discloses oral dosage forms (i.e. a
pharmaceutical composition for oral administration. Final Act. 6 (citing
Oshlack Abstr., col. 2, ll. 44–49). The Examiner finds that Oshlack teaches
controlled release beads, which may comprise an overcoat and a coating of a
hydrophobic material over an opioid analgesic, and discloses Oshlack
further discloses that buprenorphine is an opioid agonist that is analgesically
effective when administered orally. Id. (citing Oshlack col. 18, ll. 5–10, 20–
45, col. 12, ll. 33–40, claim 14).
Appellants argue that the language of the preamble of claim 199
reciting: “A pharmaceutical composition for oral administration,” as defined
in Appellants’ Specification, expressly excludes dosage forms designed for
administration by lingual, sublingual, buccal, or any other oro-mucosal route
of delivery. App. Br. 15 (citing Spec. ¶ 468). Appellants assert that,
because the Specification expressly defines this term, and because the term
“breathes life and meaning into the claim,” despite its occurrence in the
preamble of claim 199, it must therefore be interpreted in the manner set
forth by the Specification. Id. Consequently, Appellants argue, because that
term is limiting upon the claim, Oshlack fails to disclose Appellants’
claimed invention. Id.
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According to Appellants, Oshlack discloses administration of various
opioids in various dosage forms, including transdermal systems,
suppositories, and oral dosage forms. App. Br. 15 (citing Oshlack col. 30, ll.
51–65 et seq., col. 32, ll. 5–13 et seq., col. 17, ll. 44–66 et seq., col. 19, ll.
30-39 et seq.). Appellants also acknowledge that Oshlack also discloses a
variety of opioids, including buprenorphine. Id. (citing Oshlack col. 12, ll.
34–65). However, Appellants contend, Oshlack does not disclose inclusion
of buprenorphine in any oral dosage form, i.e., in a “pharmaceutical
composition for oral administration.” Id. Therefore, argue Appellants,
Oshlack fails to anticipate claim 199. Id.
Appellants argue further that the Examiner has identified Example 8
of Oshlack as disclosing a description of a pharmaceutical composition
similar to Appellants’ claimed compositions. App. Br. 15 (citing telephone
interview, September 1, 2016). However, argue Appellants, Example 8 of
Oshlack teaches naltrexone-containing beads that are coated with a CRM for
inclusion within an orally-administrable capsule. Id. Appellants assert that
Example 8 does not disclose a buprenorphine-containing composition. Id.
Appellants point to the Declaration of Dr. Charles E. Inturrisi, December 12,
2015 (the “Inturrisi Declaration”) as stating that a person of ordinary skill
would not have substituted buprenorphine in place of naltrexone.
Specifically, Appellants argue, Dr. Inturrisi opines that orally ingested
buprenorphine exhibited drawbacks that rendered such administration
inappropriate by the oral route. Id. at 15–16 (citing Inturrisi Decl. ¶ 17).
Therefore, assert Appellants, a person of ordinary skill, comprehending the
disclosures of Oshlack as of the date of filing, would not have reasonably
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understood that buprenorphine could be used in pharmaceutical
compositions for oral administration. Id.
Finally, Appellants note the Examiner’s reliance upon P.A. Donaher
et al., Managing Opioid Addiction with Buprenorphine, 73(9) AMERICAN
FAMILY PHYSICIAN 1573–78 (2006) (“Donaher”) as evidence that that: “oral
and sublingual (i.e., oral) formulations of buprenorphine were known and
available” as of the filing date of Appellants’ application. App. Br. 16
(quoting Final Act. 10). Appellants contend that Donaher, however,
discloses administration of buprenorphine only by sublingual and other oro-
mucosal delivery routes, which are expressly excluded by the definition of
the term “pharmaceutical composition for oral administration” in the
Applicants’ Specification. Id. Appellants assert that Donaher does not
disclose that buprenorphine could be effectively administered by oral
administration, and therefore does not alter what was known in the art about
the unsuitability of buprenorphine for oral administration, as described in the
Inturrisi Declaration. Id.
We agree with the Examiner that Oshlack anticipates the claims on
appeal. Oshlack is directed to “an oral dosage form comprising a
therapeutically effective amount of an opioid analgesic; an opioid
antagonist; and a bittering agent in an effective amount to impart a bitter
taste to an abuser upon administration of the dosage form after tampering.”
Oshlack Abstr. Specifically, Oshlack discloses that:
The opioid analgesic/opioid antagonist formulation in
combination with one or more aversive agents can be formulated
as an immediate release formulation or controlled release oral
formulation in any suitable tablet, coated tablet or
multiparticulate formulation known to those skilled in the art.
The controlled release dosage form may include a controlled
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release material which is incorporated into a matrix along with
the opioid analgesic and the opioid antagonist. In addition, the
aversive agent may be separate from the matrix, or incorporated
into the matrix

and that:

The controlled release bead formulations of the present invention
slowly release the opioid analgesic e.g., when ingested and
exposed to gastric fluids, and then to intestinal fluids.

Oshlack col. 17, ll. 12–21; col. 18, ll. 4–7 (emphases added). We therefore
find that Oshlack expressly teaches oral administration as defined by
paragraph [0468] of Appellants’ Specification, i.e., “any method of
administration through the mouth for rapid deposit into the stomach or
alimentary canal.”
Oshlack further discloses:
In certain preferred embodiments, the oral dosage form
comprises an orally therapeutically effective dose of an opioid
agonist, and an opioid antagonist in a ratio that provides a
combination product which is analgesically effective when the
combination is administered orally, but which is aversive in
physically dependent human subjects when administered at the
same dose or at a higher dose than said therapeutically effective
dose

and that

In certain preferred embodiments, the opioid agonist is selected
from the group consisting of hydrocodone, morphine,
hydromorphone, oxycodone, codeine, levorphanol, meperidine,
methadone, oxymorphone, buprenorphine, fentanyl and
derivatives thereof, dipipanone, heroin, tramadol, etorphine,
dihydroetorphine, butorphanol, levorphanol, or salts thereof or
mixtures thereof. In certain preferred embodiments, the opioid
agonist is oxycodone or hydrocodone.
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Oshlack col 11, ll. 12–20; col. 12, ll. 57–65 (emphases added).
Consequently, we agree with the Examiner that Oshlack expressly discloses
the use of opioid agonist/antagonist combinations, in which buprenorphine is
a preferred opioid agonist, incorporated into a composition with a controlled
release material, and intended to be orally administered, i.e., “slowly
release[d] … when ingested and exposed to gastric fluids, and then to
intestinal fluids.” Id. at col. 18, ll. 5–7.
With respect to the Inturrisi Declaration, Dr. Inturrisi attests that:
As of March 9, 2009, buprenorphine was known by POSITAs to
be inappropriate for administration by the oral route (i.e.,
administration dosage forms such as capsules and tablets through
the mouth for rapid deposit into the stomach or alimentary canal),
even though buprenorphine was known by POSITAs to be
appropriate for administration by absorption through oral cavity
surfaces (e.g., by the lingual, sub lingual, oro-mucosal,
transmucosal, or buccal routes)

and that: “As of March 9, 2009, I was unaware of any commercially-
available preparation of buprenorphine intended for administration to
humans by the oral route.” Inturrisi Decl. 9, 10. Dr. Inturrisi further opines
that: “The Oshlack Patent does not disclose that buprenorphine can be
effectively administered by the oral route. The Oshlack Patent discloses no
information that I believe would cause a POSITA to ignore (or even
reconsider) the known impracticality of administering buprenorphine by an
oral route prior to March 9, 2009.” Id. at 15.
Although we accord Dr. Inturrisi’s expert opinion due weight, we find
that the evidence presented of whether a person of ordinary skill in the art at
the time of invention would have known that oral administration of
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buprenorphine was not as efficient as other methods to be more relevant to
an obviousness analysis under Section 103 than to anticipation under Section
102. “[A]nticipation requires that the four corners of a single, prior art
document describe every element of the claimed invention, either expressly
or inherently, such that a person of ordinary skill in the art could practice the
invention without undue experimentation.” Advanced Display Sys., Inc. v.
Kent State University, 212 F.3d 1272, 1282 (Fed. Cir. 2000) 212 F.3d 1272
(citing Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999);
In re Paulsen, 30 F.3d 1475, 1479 (Fed. Cir. 1994)). As we have explained,
Appellants have failed to persuade us that the Examiner erred in finding that
Oshlack discloses all of the limitations recited in the claims.
Finally, we need not address whether the preambular language
reciting: “A pharmaceutical composition for oral administration,” as defined
by Appellants’ Specification is limiting upon the claim, as argued by
Appellants. See App. Br. 15. Even were we to agree, arguendo, with
Appellants’ argument upon this point, it would not alter our conclusion that
Oshlack anticipates Appellants’ claims because, as we have explained,
Oshlack expressly discloses that its compositions can be administered orally
in a manner consistent with Appellants’ exclusive definition of that term.
We therefore conclude that Oshlack anticipates the limitations of the
claims on appeal, and we affirm the Examiner’s rejection of claims 199–207
and 209–213.

DECISION
The Examiner’s rejection of claims 199–207 and 209–213 as
unpatentable under 35 U.S.C. § 112, first paragraph, is reversed.
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The Examiner’s rejection of claims 199 and 204 as unpatentable under
35 U.S.C. § 112, second paragraph, is reversed.
The Examiner’s rejection of claims 199–207 and 209–213 as
unpatentable under 35 U.S.C. 102(b) is affirmed.
The Examiner’s rejection of claims 199–202, 205, 206, 209, 210, 212,
and 213 as unpatentable under the nonstatutory doctrine of obviousness-type
double patenting is affirmed.
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv).

AFFIRMED