Ex Parte Bologna et al

Patent Trial and Appeal Board

Oct 29, 2012

10423920 (P.T.A.B. Oct. 29, 2012)

UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
__________

Ex parte WILLIAM J. BOLOGNA and HOWARD L. LEVINE
__________

Appeal 2012-002221
Application 10/423,920
Technology Center 1600
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Before TONI R. SCHEINER, DEMETRA J. MILLS, and ERIC GRIMES,
Administrative Patent Judges.

MILLS, Administrative Patent Judge.

DECISION ON APPEAL

This is an appeal under 35 U.S.C. § 134. The Examiner has rejected
the claims for obviousness-type double patenting, anticipation, obviousness
and indefiniteness. We have jurisdiction under 35 U.S.C. § 6(b).
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STATEMENT OF THE CASE
The following claims are representative of the claims on appeal.
1. A bioadhesive pharmaceutical composition comprising an
ionic treating agent and an ionic polymer, wherein the composition is free of
an oil phase; the polymer is sufficiently ionized to provide bonding with the
treating agent to release the treating agent in a controlled manner over an
extended period of time; and the composition is in the form of a gel at the
time of administration.

6. The composition of claim 2, wherein the polymer is sufficiently
ionized to provide bioadhesion.

30. A method of treating a disease or condition in a patient in need
thereof comprising administering a composition in the form of a gel that
comprises a therapeutically effective amount of an ionic treating agent and
an ionic polymer; wherein the polymer is sufficiently ionized to provide
bonding with the treating agent; wherein the composition is free of an oil
phase and is in the form of a gel at the time of administration; and the
treating agent is released in a controlled manner over an extended period of
time through chemical bonding with the polymer.

Cited References

The Examiner relies on the following prior art references:

Bologna et al. US 6,479,045 B2 Nov. 12, 2002
Della Valle et al. US 5,876,744 Mar. 2, 1999
Harrison et al. US 6,086,909 Jul. 11, 2000
Nakao et al. US 6,303,628 B1 Oct. 16, 2001

Grounds of Rejection
 Claims 1-19 and 24-42 are rejected on the ground of
nonstatutory obviousness-type double patenting as being
unpatentable over U.S. Patent No. 6,479,045 in view of Della
Valle and Harrison.

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 Claims 6 and 30 are rejected under 35 U.S.C. §112, second
paragraph, as being indefinite for failing to particularly point
out and distinctly claim the subject matter which Appellants
regard as the invention.

 Claims 1, 2, and 6-14 are rejected under 35 U.S.C. §102(b) as
being anticipated by Della Valle.

 Claims 1-19 and 24-42 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Bologna in view of over Della Valle,
Harrison and Nakao.

FINDINGS OF FACT
The Examiner’s findings of fact are set forth in the Answer at pages 5-
10.

Discussion
 Claims 1-19 and 24-42 are rejected on the ground of
nonstatutory obviousness-type double patenting as being
unpatentable over U.S. Patent No. 6,479,045 [Bologna] in view
of Della Valle and Harrison.

ISSUE
The Examiner concludes that
[t]he Patent '045 recites a pharmaceutical composition comprising a
water swellable cross-linked polycarboxylic acid polymer (see claim
1), such as polycarbophil (see claim 2), wherein the composition is a
gel (see claim 3), wherein the composition is formulated to provide a
vaginal dose (see claim 4). Additionally, one example having no oil
phase (see col. 5, Table 1); and polycarbophil has been used in a
variety of drug delivery systems (see col. 4, line 52-65).
Patent '045 does not teach using a treating agent such as
lidocaine.
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DELLA VALLE teaches a bioadhesive composition suitable for
releasing an active ingredient (see abstract) intravaginally (see col. 16,
line 22-28) comprised of: an ionic polymer, such as polycarbophil,
wherein the composition does not have oil, which would be free of an
oil phase, and is in the form of a gel (see col. 17-18, especially
Examples 13, 22 and 23). Additional disclosure includes:
polycarbophil is used as a bioadhesive vehicle for the controlled
release of active principles (see col. 4, line 8-17).
HARRISON teaches a composition comprised of: a treating
agents, such as lidocaine . . . , wherein the composition does not have
oil, which would be free of an oil phase, and is in the form of a gel
(see col. 2, line 43) for intravaginal delivery to treat dysmenorrhea
(see abstract).
It would have been obvious to the person of ordinary skill in the
art at the time the invention was made to incorporate the treating
drugs as claimed by Appellant into Patent '045. The person of
ordinary skill in the art would have been motivated to make those
modifications, because treating drug would have an[ ] additive effect
in treating dysmenorrhea and the bioadhesive composition of Patent
'045 would allow attachment of the lidocaine drug to the vaginal
mucosal wall and reasonably would have expected success because
both references dealt with the same field of endeavor of vaginal gel.

(Ans. 5-6.)

Appellants argue that “1) the rejection is improper for referring to
additional materials besides the claims at issue; 2) there is no motivation to
combine these references anyway; and 3) even viewed in combination, the
art of record does not render obvious the instant claims.” (App. Br. 12.)
More particularly, Appellants argue that “Bologna does not require any
independent treating agent, let alone an ionic treating agent that interacts
with the ionic polymer.” (Id. at 14.) Appellants argue that “Della Valle does
not disclose any specific treating agents, let alone teach, suggest or
recognize any ionic interaction between a treating agent and any one or more
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of the polymers. Nor does Della Valle in any way recognize that any
polymer may be sufficiently ionized to provide both suitable bioadhesion
and sufficient interaction with the treating agent.” (Id.) Appellants argue
that “Harrison does not teach or suggest using an ionic polymer at all, let
alone to meet the instant claimed requirements. Accordingly, Harrison
should be deemed irrelevant to the claimed invention.” (Id. at 16.)
The issue is: Has the Examiner provided sufficient evidence in the
prior art to support a prima facie case of obviousness-type double patenting?

PRINCIPLES OF LAW
“Obviousness-type double patenting is a judge-made doctrine that
prevents an extension of the patent right beyond the statutory time
limit. It requires rejection of an application claim when the claimed
subject matter is not patentably distinct from the subject matter
claimed in a commonly owned patent. Its purpose is to prevent an
unjustified extension of the term of the right to exclude granted by a
patent by allowing a second patent claiming an obvious variant of the
same invention to issue to the same owner later.” In re Berg, 140
F.3d 1428, 1431 (Fed. Cir. 1998) (citation omitted).

Because nonstatutory double patenting compares earlier and later
claims, an earlier patent’s disclosure is not available to show nonstatutory
double patenting. See Gen. Foods Corp. v. Studiengesellschaft Kohle mbH,
972 F.2d 1272, 1281-82 (Fed. Cir. 1992).
“‘It is impermissible within the framework of section 103 to pick and
choose from any one reference only so much of it as will support a
given position, to the exclusion of other parts necessary to the full
appreciation of what such reference fairly suggests to one of ordinary
skill in the art.’” In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986)
(quoting In re Wesslau, 353 F.2d 238, 241 (CCPA 1965)).

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ANALYSIS
We do not find that the Examiner has provided evidence to support a
prima facie case of obviousness-type double patenting. We agree with
Appellants that the Examiner has failed to provide evidence in the claims of
Bologna of an ionic treating agent that interacts with the ionic polymer, and
that Della Valle does not disclose, suggest or recognize any ionic interaction
between a treating agent and any one or more of the polymers. Nor does
Della Valle in any way recognize that any polymer may be sufficiently
ionized to provide both suitable bioadhesion and sufficient interaction with
the treating agent. The Examiner’s selection of an ionic treating agent from
Harrison is no more than picking and choosing from Harrison only so much
of it as will support a given position, to the exclusion of other parts
necessary to the full appreciation of what such reference fairly suggests to
one of ordinary skill in the art. See In re Hedges, 783 F.2d 1038, 1041 (Fed.
Cir. 1986). For example, Harrison discloses the incorporation of a drug into
a gel-like bioadhesive reservoir for vaginal delivery. (Col. 9, ll. 34-35.)
Harrison discloses mucoadhesive agents such as methylcellulose having no
ionic charge in the bioadhesive reservoir. (Cols. 18 and 14; App. Br. 16).
There is no suggestion in Harrison to pair or select an ionic treating agent
with an ionic polymer.
In view of the above, the obviousness-type double patenting rejection
is reversed.

Discussion
 Claims 6 and 30 stand rejected under 35 U.S.C. §112, second
paragraph, as being indefinite for failing to particularly point
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out and distinctly claim the subject matter which Appellants
regard as the invention.

The Examiner finds that

the term "sufficiently ionized" in claim 6 is a relative term,
which renders the claim indefinite. The term "sufficiently" 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
scope of the invention. It is not clear what level of the closeness
constitutes of "sufficiently". Therefore, one would not know
what are the metes and bounds of the claims.
(Ans. 7.)

Appellants argue that

paragraphs [0032], [0042], and [0043] of the published specification
clearly demonstrate that the composition comprises an ionic polymer
and ionic treating agent, that can optionally include a cross-linking
agent, and that the ionic radicals are the mechanism of attachment to
the epithelial cells of a mucosal surface. Further, paragraphs [0070]
through [0074] detail how to alter the compositions such that
bioadhesion is maximally attained to the epithelial surface, depending
upon the specific ionic polymer, treating agent and optional cross-
linking agent.
… A skilled artisan knows that the degree of ionization of a polymer
is effected by the entirety of the formulation ingredients and the
process for preparing the formulation. The specification makes clear
that the polymer needs to be sufficiently ionized both to provide
bioadhesion and bond with treating agents so as to release treating
agents at the desired place[ ] and over the desired period of time.
Paragraph [0070] states that at least about 80% of the monomers of
the polymer should contain at least one carboxyl functionality.
Paragraph [0075] states that "these polymers would not be used in
their salt form, because this would decrease their bioadhesive
capability and also inhibit binding of ionic drugs." Thus one of skill
in the art at the time the invention was made would readily know there
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must be sufficient ionization of the polymer in order to provide
bioadhesion and extended controlled release.

(App. Br. 20.)

The Examiner’s response to these arguments of Appellants is that the
prior art’s polycarbophil meets all these requirements. (Ans. 16.)
We find that the Appellants have provided support in the
Specification and argument that one of ordinary skill in the art would
understand what is meant by the terminology "sufficiently ionized" in claims
6 and 30. The Examiner’s response to Appellants’ arguments fails to rebut
what Appellants proffer to be the understanding of the terminology by one
of ordinary skill in the art. Furthermore, the Examiner’s statement that the
prior art’s polycarbophil meets all these requirements would appear to be an
admission that the meaning of the claim terminology "sufficiently ionized"
is understood by one of ordinary skill in the art.
The indefiniteness rejection is reversed.

Discussion

 Claims 1, 2, and 6-14 are rejected under 35 U.S.C. §102(b) as
being anticipated by Della Valle.

 Claims 1-19 and 24-42 are rejected under 35 U.S.C. §103(a) as
being unpatentable over Bologna in view of over Della Valle,
Harrison and Nakao.

PRINCIPLES OF LAW
In order for a prior art reference to serve as an anticipatory reference,
it must disclose every limitation of the claimed invention, either explicitly or
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inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). To
anticipate, every element and limitation of the claimed invention must be
found in a single prior art reference, arranged as in the claim. Karsten Mfg.
Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001).
“In rejecting claims under 35 U.S.C. § 103, the examiner bears the
initial burden of presenting a prima facie case of obviousness. Only if that
burden is met, does the burden of coming forward with evidence or
argument shift to the applicant.” In re Rijckaert, 9 F.3d 1531, 1532 (Fed.
Cir. 1993) (citations omitted). In order to determine whether a prima facie
case of obviousness has been established, we consider the factors set forth in
Graham v. John Deere Co., 383 U.S. 1, 17 (1966): (1) the scope and content
of the prior art; (2) the differences between the prior art and the claims at
issue; (3) the level of ordinary skill in the relevant art; and (4) objective
evidence of nonobviousness, if present.
Moreover, “obviousness 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)).

ANALYSIS
With respect to the anticipation rejection, the Examiner argues that
DELLA VALLE teaches a composition comprised of: an ionic
treating agent, such as dermatan sulfate; and an ionic polymer, such as
polycarbophil, wherein the composition does not have oil, which
would be free of an oil phase, and is in the form of a gel (see col. 18,
Example 22). Additional disclosure includes: triethanolamine (see
col. 18, Example 22), which would read on cationic complexing
agent; polycarbophil is used as a bioadhesive vehicle for the
controlled release of active principles (see col. 4, line 8-17; and col.
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17, line 33-36). Thus, DELLA VALLE's composition would
inherently have the same release profile as claimed by Appellant,
since DELLA VALLE's composition has the same ingredients as
claimed by Appellant.

(Ans. 8.)

Appellants argue that the “dermatan sulfate discussed in Della Valle is
used not as a treating agent but as a potential biopolymer in the base
formulation that itself can provide either tissue moisturization or
percutaneous delivery of a treating agent.” (App. Br. 21.) Appellants argue
that “both polycarbophil and dermatan sulfate are anionic – and would not
bind each other” as claimed (Id. at 22.)
The Examiner has failed to provide a response to or evidence to rebut
Appellants’ argument that “both [Della Valle’s] polycarbophil and dermatan
sulfate are anionic – and would not bind each other” as claimed. (Id.) In
other words, the Examiner has not provided sufficient evidence to support
his position that the Della Valle composition would inherently have the same
release profile as the instant claims.
As set forth in In re Oelrich, 666 F.2d 578, 581, 212 USPQ 323, 326
(CCPA 1981)(quoting Hansgirg v. Kemmer, 102 F.2d 212, 214, 40 USPQ
665, 667 (CCPA 1939)) (internal citations omitted):
Inherency, however, may not be established by probabilities or
possibilities. The mere fact that a certain thing may result from
a given set of circumstances is not sufficient. If, however, the
disclosure is sufficient to show that the natural result flowing
from the operation as taught would result in the performance of
the questioned function, it seems to be well settled that the
disclosure should be regarded as sufficient.

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In view of Appellants’ argument that “both [Della Valle’s]
polycarbophil and dermatan sulfate are anionic – and would not bind
each other” the Examiner has failed to provide sufficient evidence to
support his inherency argument. (App. Br. 22.)
The anticipation rejection is reversed.
With respect to the obviousness rejection over Bologna in view of
over Della Valle, Harrison and Nakao, the Examiner essentially relies on
Bologna, Della Valle and Harrison for the reasons set forth in the
obviousness-type double patenting rejection. The Examiner further finds
that “NAKAO disclosed zileuton was a known drug in the prior art.” (Ans.
10.)
The Examiner concludes that
It would have been obvious to the person of ordinary skill in the art at
the time the invention was made to incorporate the treating agents as
claimed by Appellant into BOLOGNA's or DELLA VALLE's
composition. The person of ordinary skill in the art would have been
motivated to make those modifications, because the treating agent
would provide an additive effect in treating dysmenorrhea and
BOLOGNA's bioadhesive composition would allow attachment of the
lidocaine drug to the vaginal mucosal wall and reasonably would have
expected success because both references dealt with the same field of
endeavor of vaginal gel.

(Ans. 10.)

Appellants argue that there is no combination of the cited art that
results in the claimed invention. “Bologna does not address independent
treating agents, while Della Valle and Harrison fail to teach or rely on ionic
interactions.” (App. Br. 25.) Appellants rely on their arguments regarding
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these references as presented with respect to the obviousness-type double
patenting rejection. (See id.)
We agree with Appellants that the Examiner has failed to provide
evidence in the prior art of Bologna of an ionic treating agent that interacts
with the ionic polymer, and that Della Valle does not disclose, suggest or
recognize any ionic interaction between a treating agent and any one or more
of the polymers. Nor does Della Valle in any way recognize that any
polymer may be sufficiently ionized to provide both suitable bioadhesion
and sufficient interaction with the treating agent. (App. Br. 6.) As discussed
above, the Examiner’s selection of an ionic treating agent from Harrison is
no more than picking and choosing from Harrison only so much of it as will
support a given position, to the exclusion of other parts necessary to the full
appreciation of what such reference fairly suggests to one of ordinary skill in
the art. See In re Hedges, 783 F.2d 1038, 1041 (Fed. Cir. 1986).
In view of the above, the obviousness rejection is reversed.

CONCLUSION OF LAW
The cited references do not support the Examiner’s obviousness–type
double patenting, obviousness, anticipation and indefiniteness rejections,
which are reversed.

REVERSED

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