Ex Parte Vaghefi et al

Patent Trial and Appeal Board

May 28, 2013

10528727 (P.T.A.B. May. 28, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte FARID VAGHEFI, GARY G. LIVERSIDGE,
STEPHEN B. RUDDY, and EUGENE R. COOPER
____________

Appeal 2012-000385
Application 10/528,727
1

Technology Center 1600
____________

Before DEMETRA J. MILLS, JOHN A. EVANS, and
ULRIKE W. JENKS, Administrative Patent Judges.

EVANS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134(a) involving claims to abuse-
resistant controlled-release pharmaceutical compositions. The Examiner has
rejected the claims as failing the written description requirement and
obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.

1
The real party in interest is Elan Pharma International, LTD.
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Application 10/528,727

2
Rather than reiterate the arguments of Appellants and the Examiner,
we refer to the Appeal Brief (filed May 12, 2011), the Answer (mailed Aug.
4, 2011), and the Reply Brief (filed Oct. 4, 2011).
STATEMENT OF THE CASE
The claims relate to
abuse-resistant controlled release pharmaceutical compositions
comprising a pharmaceutically effective amount of discrete
particles of an active capable of abuse, wherein surfaces of said
particles are wetted with a water insoluble coating material, and
preferably wherein said composition comprises a matrix, in
which said particles are distributed, and which renders the
abuse-capable compound within the matrix difficult to
separate from the matrix; and a method for the preparation of a
controlled release pharmaceutical composition having a reduced
potential for abuse, comprising applying a pressure force to a
mixture comprising a water insoluble material, and particles of
a pharmaceutically active compound capable of inducing in a
subject a reaction that is physiologically or psychologically
detrimental if administered in an immediate release dosage
form, thereby resulting in surface coated particles, and
incorporating said surface coated particles into a
pharmaceutical composition.

(Spec. Abstract.)
Claims 1, 4, 5, 9, 11, 24, and 40 are on appeal; claims 2, 3, 6-8, 10,
25, and 26 are cancelled; claims 12-23 and 27-39 are withdrawn. Claim 1 is
independent. (App. Br. 29-36.) The claims have not been argued separately
and therefore stand or fall together. 37 C.F.R. § 41.37(c)(1)(iv). An
understanding of the invention can be derived from a reading of exemplary
claim 1, which is reproduced below:
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1. An abuse-resistant controlled-release pharmaceutical
composition comprising a plurality of microspheres, each
microsphere comprises:
(i) a water insoluble matrix material, and
(ii) a plurality of discrete particles distributed throughout the water
insoluble matrix material, each particle comprises a
pharmaceutically effective amount of an active water soluble
compound capable of abuse and having surfaces that are wetted
with a coating of the water insoluble matrix material,
wherein said water insoluble matrix material is present in an
abuse-reducing amount whereby crushing, compressing,
fracturing, tumbling, rolling, or milling of said controlled-release
pharmaceutical composition results in an increase in the aqueous
dissolution of said active water soluble compound by less than
about 15% of the total pharmaceutically effective amount of the
active water soluble compound in the composition in the first hour
of in vitro dissolution testing,
wherein the water soluble compound capable of abuse is an
opioid agonist, and
wherein the composition does not include an antagonist of
the water soluble compound capable of abuse.

Claims 1, 4, 5, 9, 11, 24, and 40 are rejected under 35 U.S.C. § 112,
first paragraph, as failing to comply with the written description
requirement. This is a new matter rejection. (Ans. 5-6.)
Claims 1, 9, 11, 24, and 40 are rejected under 35 U.S.C. § 103(a) as
obvious over Cain.
2
(Ans. 7-10.)

THE WRITTEN DESCRIPTION REJECTION
ISSUE
Appellants‟ contentions raise the issue of whether the Specification
and claims as originally filed provided clear written description for the

2
Cain et al., US 3,402,240, Sept. 17, 1968.
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limitations, newly-added to claim 1, wherein (1) the water soluble
compound capable of abuse is an opioid agonist; and (2) wherein the
composition does not include an antagonist of the water soluble compound
capable of abuse.
ANALYSIS
Appellants rely on MPEP § 2162.05 for the proposition that there is
not an ipsissima verba requirement for satisfaction of the written description
requirement, but that satisfaction may be achieved by express, implicit, or
inherent support of claim limitations in the originally-filed disclosure. (App.
Br. 12-13.) In particular, Appellants contend that the written description
requirement for a claimed genus may be satisfied through sufficient
description of a representative number of species. Appellants cite to MPEP §
2163.05(b) for the proposition that a “representative number of species”
means that the species which are adequately described are representative of
the entire genus. Appellants contend that even where there is substantial
variation within the genus, disclosure of a sufficient variety of species that
reflect the variation within the genus would properly satisfy the written
description requirement for broadening the scope of the claims. (App. Br.
13.)
Opioid agonist. Appellants contend that the Specification disclosure at
page 7, line 15 through page 8, line 16 provides an adequate number of
opioid species to support the recitation of the genus “opioid agonist.” (App.
Br. 7.) Appellants further contend that the art recognizes that only a small
number of opioid species will support the recitation “opioid agonist.” (Reply
Br. 5)(citing, inter alia, US 4,626,539 which recites and claims opioid
agonist, but only discloses two species thereof.)
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The Examiner finds that the disclosure of specific species of opioid
agonist supports the explicitly-disclosed compounds, but does not support
disclosure of the genus of opioid agonists. (Ans. 5.) The Examiner does not
reply to Appellants implied query (App. Br. 13) regarding how many species
must be disclosed to comprise a “representative number.”
Appellants contend that a “disclosure of a functional recitation of
known compounds in the specification may be sufficient as adequate
description for such compounds.” (App. Br. 13)(citing In re Herschler, 591
F.2d 693, 697 (CCPA 1979)). Appellants further contend that the Courts, in
certain circumstances, have held that disclosure of a single species supports
a genus claim. Appellants contend that in Smythe, the disclosure of a single
species, air, which was inert to a liquid, was sufficient to support a claim to
the genus “‟inert fluid media‟” because the description of the properties and
functions of the air or other gas would suggest to a person skilled in the art
that appellant‟s invention includes the use of “‟inert fluid‟” broadly. (App.
Br. 13)(citing In re Smythe, 480 F.2d 1376, 1383 (CCPA 1973)). Appellants
further contend that a single method of adheringly-applying one layer to
another was sufficient to support a generic claim to “adheringly applying”
because one skilled in the art reading the specification would understand that
it is unimportant how the layers are adhered, so long as they are adhered.
(App. Br. 14)(citing In re Rasmussen, 650 F.2d 1212, 1214 (CCPA 1981)).
We agree with Appellants that the disclosure of 68 species of
“pharmaceutically acceptable opiates and opiate-based derivatives that are
suitable for use as a therapeutically effective analgesic” (App. Br. 18; Spec.
7) is a “representative number of species” to suggest the genus “opioid
agonist” to the skilled pharmaceutical formulator.
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Opioid antagonists.
The Examiner argues that
[T]he instant specification fails to recite any description or
limitation directed to the specific exclusion of an antagonist of the
water soluble compound capable of abuse. In fact, the specification
and/or claims are silent as to the inclusion or exclusion of such a
compound and, therefore, fail to provide clear written support to claim
an embodiment of the instant abuse-resistant pharmaceutical
composition wherein an antagonist of the water soluble compound
capable of abuse is not permitted as a component of the composition.
This newly added limitation represents a clear narrowing of the
subject matter both claims and disclosed in the specification and
claims as originally filed that is not adequately supported by the
original disclosure and clearly circumscribes a concept that was not in
Appellant's possession at the time of the invention.

(Ans. 6.)
Appellants contend that the Specification states that “no prior art
controlled release formulation is without an opioid antagonist for the
intended purpose instantly claimed.” (App. Br. 18)(citing Spec. p. 3, ll. 8-
10)(“There are no prior art reports disclosing controlled release formulations
that do not employ opioid antagonists of one form or another and that might
be capable of reducing the potential for abuse of narcotic analgesics”).
Thus, Appellants argue that this language in the Specification supports the
negative claim limitation, “wherein the composition does not include an
antagonist of the water soluble compound capable of abuse” and that the
negative limitation is not new matter to the application and has basis in the
original disclosure.
The function of the description requirement is to ensure that the
inventor had possession of, as of the filing date of the application
relied upon, the specific subject matter later claimed by him; how the
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specification accomplishes this is not material. The claimed subject
matter need not be described in haec verba to satisfy the description
requirement. It is not necessary that the application describe the claim
limitations exactly, but only so clearly that one having ordinary skill
in the pertinent art would recognize from the disclosure that appellants
invented … [subject matter] including those limitations.

In re Herschler, 591 F.2d 693, 700 (CCPA 1979).

We agree with Appellants that the original disclosure in the
Specification p. 3, ll. 8-10 would reasonably support the negative limitation,
“wherein the composition does not include an antagonist of the water soluble
compound capable of abuse” in claim 1. We find that one having ordinary
skill in the pertinent art would recognize from the disclosure page 3 that
Appellants invented compositions including that limitation.
In view of the above, the new matter rejections are reversed.

THE OBVIOUSNESS REJECTIONS
ISSUES
The Examiner finds that Cain teaches a matrix of ground carnauba
wax having interconnecting voids therein, in which, are embedded a mixture
of active ingredient and filler. The Examiner finds the active ingredient is
intimately embedded within the matrix and therefore, “coated” with the
matrix. (Ans. 16.)
Appellants contend that Cain does not teach that each of the plurality
of active ingredient particles is “„wetted with a coating of the matrix
material.‟” (App. Br. 24.) Appellants contend that Cain relates to a tablet
formulated by dry-mixing a matrix material, active drug, and other materials
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which are then dried and compressed into a tablet. (App. Br. 25) Appellants
contend that Cain provides no teaching of a microsphere “wetted with a
coating of the matrix material,” as claimed (Id.) Appellants contend that
Cain does not teach a step of melting the carnauba wax so as to wet the drug
particles. (Id.)
Appellants‟ contentions provide two dispositive issues for resolution:
(1) whether Cain fairly teaches or suggests that each claimed particle within
the claimed microspheres is “wetted with a coating of the matrix material”;
and (2) whether Cain teaches or suggests a plurality of microspheres.

ANALYSIS
The burden is on the Examiner to set forth a prima facie case of
unpatentability. See In re Glaug, 283 F.3d 1335, 1338 (Fed. Cir. 2002).
We do not find that the Examiner‟s evidence, Cain, is sufficient to support a
prima facie case of obviousness. “[O]bviousness requires a suggestion of all
limitations in a claim.” CFMT, Inc. v. Yieldup Intern. Corp., 349 F.3d 1333,
1342 (Fed. Cir. 2003) (citing In re Royka, 490 F.2d 981, 985 (CCPA 1974)).
In particular, we do not find that the Examiner has provided evidence in the
prior art wherein each of a plurality of microspheres is wetted with a coating
of the water insoluble matrix material, as claimed.
The Specification provides no definition of the term “wetted” so we
interpret the term with its ordinary meaning, which is “covered or soaked
with a liquid.” (http://www.thefreedictionary.com/wetted)
The Examiner finds that Cain teaches a matrix of ground carnauba
wax having interconnecting voids therein, in which, are embedded a mixture
of active ingredient and filler. The Examiner finds the active ingredient is
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intimately embedded within the matrix and therefore, “coated” with the
matrix. (Ans. 16.) We do not agree with the Examiner that active ingredient
embedded in a matrix as disclosed in Cain is the equivalent of covering or
soaking each microsphere with a liquid.

“Plurality of microspheres.” Appellants contend that Cain does not
teach the “plurality of microspheres” of the claimed formulation. (App. Br.
26.)
The Examiner finds that Cain teaches small particles of active
material embedded in aggregated particles of a ground carnauba wax matrix.
The Examiner finds that this meets the limitation plurality of
“microparticles.” (Ans. 17.)
Appellants contend that Cain teaches formation of tablets, but does
not teach the claimed “microspheres.” (App. Br. 25.) Claim 1 recites, inter
alia, “a plurality of microspheres, each microsphere comprises…a water
insoluble matrix material, and (ii) a plurality of discrete particles distributed
throughout the water insoluble matrix.” We do not find that Cain teaches a
plurality of discrete particles within a matrix. Cain discloses that the finished
tablets will comprise a:
matrix consisting of an aggregate of the ground carnauba wax
having interconnecting voids therein, in which are embedded an
intimate mixture of the active ingredient and the filler.

(Cain, col. 4, ll. 18-21.) Cain discloses two continuous, interpenetrating
phases, not discrete particles. (See Cain, Figures 4 and 5.)
Because Cain does not teach wetted particles, nor discrete particles,
we decline to sustain the rejection of claims 1, 4, 5, 9, 11, 24, and 40.
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SUMMARY

We reverse the rejection of claims 1, 4, 5, 9, 11, 24, and 40 under 35
U.S.C. § 112, first paragraph.
We reverse the rejection of claims 1, 4, 5, 9, 11, 24, and 40 under 35
U.S.C. § 103.

REVERSED

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