Daniel Banov

Patent Trials and Appeals Board

Jul 22, 2019

13918376 - (D) (P.T.A.B. Jul. 22, 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.
13/918,376 06/14/2013 Daniel Banov 47645/15-214 5559
135404 7590 07/22/2019
GableGotwals
1100 ONEOK Plaza, 100 West 5th Street
Tulsa, OK 74103-4217
EXAMINER
CHONG, YONG SOO
ART UNIT PAPER NUMBER
1627
MAIL DATE DELIVERY MODE
07/22/2019 PAPER
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.
PTOL-90A (Rev. 04/07)

UNITED STATES PATENT AND TRADEMARK OFFICE
____________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________

Ex parte DANIEL BANOV
____________

Appeal 2019-001064
Application 13/918,376
Technology Center 1600
____________

Before JEFFREY N. FREDMAN, DEBORAH KATZ, and
JOHN G. NEW, Administrative Patent Judges.

KATZ, Administrative Patent Judge.

DECISION ON APPEAL

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Application 13/918,376

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Introduction
Appellant1 seeks our review, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 1, 6, 9–12, 17, 20, and 21. (Appeal
Brief filed June 11, 2018 (“App. Br.”) 5; Reply Brief filed November 19,
2018 (“Reply Br.”) 2.)2
We have jurisdiction under 35 U.S.C. § 6(b). We REVERSE pro
forma the rejection under 35 U.S.C. § 103, and enter new grounds of
rejection.

Analysis
Obviousness under 35 U.S.C. § 103
Appellant argues independent claims 1 and 12 together. Appellant’s
claim 1 recites3:
A method for the prevention and treatment of infections
of the respiratory tract caused by bacteria, comprising
administering to a patient in need of such treatment a
formulation comprising
mupirocin,
[0].1 % by weight to 5% by weight poloxamer 188, and
0.1 % by weight to 4% by weight poloxamer 407
wherein the poloxamer 188 and the poloxamer 407 form
a micronized poloxamer composition with an average particle
size from about 30 μm to about 70 μm and

1 Appellant reports that the real party in interest is PROFESSIONAL
COMPOUNDING CENTERS OF AMERICA (“PCCA”). (App. Br. 2.)
2 Appellants listed claims “9, 12” rather than “9–12” in the Appeal Brief and
corrected the error in the Reply Brief. We deem this to be harmless error
and review claims 9–12.
3 Claim 1 has been modified for clarity by adding spacing and indentations
to highlight the individual elements.
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wherein the poloxamer is combined with the mupirocin
in a non-gelling composition.

(App. Br. 15.)
The Examiner rejects the claims under 35 U.S.C. § 103 as obvious
over Lichter4 and Williams.5 (Final Office Action mailed January 10, 2018
(“Final Act.”) 4–9.) The Examiner finds Lichter teaches a sinonasal
formulation containing an antibiotic, e.g., mupirocin, at least about 5% by
weight poloxamer 407, and optionally poloxamer 188. (Final Act. 4–5,
citing Lichter ¶¶ 9, 59, 270, 271.) The Examiner finds Williams teaches a
formulation for treating mucous membranes, e.g., sinuses, containing about
0.1 to about 40 percent by weight mucoadhesive, e.g., poloxamers 188 and
407. (Final Act. 6–8, citing Williams 7:17–49; 17:27–30.) The Examiner
finds Williams teaches optimizing the amount of mucoadhesive to achieve a
formulation with optimal viscosity, adhesion, and drug-delivery properties.
(See Final Act. 6–8, citing Williams 5:45–6:27.)
Appellant contends that neither Lichter nor Williams describe “non-
gelling” poloxamer combinations. (See App. Br. 6–9.)
The limitation of “a non-gelling composition” was added by
amendment to independent claims 1 and 12 during prosecution. (See App.
Br. 15–16; Amendment filed October 13, 2017.) However, the limitation
“non-gelling” is not discussed in the Specification as filed. Appellant does
not direct us to, and we cannot find, a specific definition of the term “non-
gelling” in the Specification. (See App. Br. 2–4, Summary of the Claimed
Subject Matter; see also Spec. ¶¶ 14–20, Definitions.) The Specification

4 Lichter et al., WO 2011/050206 A2, published April 28, 2011
5 Williams et al., US 6,509,028 B2, issued January 21, 2003
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discloses that poloxamers “may be used as thickening agents, gel formers,
co-emulsifiers, solubilizers, and consistency enhancers in creams and liquid
emulsions.” (Specification dated June 14, 2013 (“Spec.”) ¶ 20.) However,
there is no other use of the term “gel,” “gelling,” or “non-gelling” in the
Specification.
Thus, substantial confusion exists in the record as to the proper
interpretation and scope of the appealed claims. Presently, the claims on
appeal do not adequately and clearly reflect what the disclosed invention is.
Rather than speculate further about how the present claims compare to
compositions and methods disclosed in the cited prior art, we reverse pro
forma the rejection under 35 U.S.C. § 103 at this time. Cf. In re Steele, 305
F.2d 859, 863 (CCPA 1962) (“We believe that this confusion arose and has
continued because the claims do not particularly point out and distinctly
claim the invention as required by 35 U.S.C. § 112.”) This pro forma
reversal does not limit the citation of the same (or different) prior art against
the claims in the future, should the rejections under 35 U.S.C. § 112 be
overcome through continued prosecution. As in Steele, “[o]ur decision is
not to be construed as meaning that we consider the claims on appeal to be
patentable [over the prior art] as presently drawn.” Id.

New Grounds
Lack of Written Description under 35 U.S.C. § 112(a)
We reject claims 1, 6, 9–12, 17, 20, and 21 as failing to meet the
written description requirement under 35 U.S.C. § 112(a). In particular, we
find that the claims on appeal recite new matter that is not supported by the
Specification as filed.
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Appellant’s Specification provides an antibiotic composition
including at least one antibiotic agent and a combination of two or more
poloxamers as excipients. (Spec. ¶ 6.) The Specification discloses that a
composition containing microprilled micronized poloxamer may provide a
controlled dissolution rate and elimination of dose dumping. (Spec. ¶ 27.)
“In order to satisfy the written description requirement, the disclosure
as originally filed does not have to provide in haec verba support for the
claimed subject matter at issue.” Purdue Pharma L.P. v. Faulding, Inc., 230
F.3d 1320, 1323 (Fed. Cir. 2000). Nonetheless, the disclosure must convey
with reasonable clarity to those skilled in the art that the inventor was in
possession of the invention. See id.
Here, the Specification does not convey possession of any formulation
that exhibits non-gelling properties. Rather, the Specification describes
advantages of controlled dissolution rate and elimination of dose dumping
that would be consistent with the properties of the prior art gel-forming
compositions. (See Spec. ¶ 27; see also Lichter ¶ 51; Williams 2:11–23.)
Appellant distinguishes the prior art combination, which discloses a range of
poloxamers overlapping the claimed range, without proving that the subject
matter shown to be in the prior art does not possess the non-gelling
characteristic relied on. See In re Best, 562 F.2d 1252, 1254–55 (CCPA
1977).
In Allergan v. Sandoz, the Court of Appeals for the Federal Circuit
stated that “a claim that recites a property that is necessarily inherent in a
formulation that is adequately described is not invalid as lacking written
description merely because the property itself is not explicitly described.”
Allergan, Inc. v. Sandoz Inc., 796 F.3d 1293, 1309 (Fed. Cir. 2015). In
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Allergan, the claimed clinical effects were supported by specific
formulations described in the Specification. See id. at 1308. Appellants’
Specification does not disclose any specific formulation containing
mupirocin, up to 5% by weight poloxamer 188, and up to 4% by weight
poloxamer. (See Spec. ¶¶ 41–43, Examples.) These facts are similar to
those in Purdue Pharma L.P. v. Faulding, Inc., where “a characteristic that
is not discussed even in passing in the disclosure” was claimed and then
made the characteristic the basis of claims that cover any formulation having
that characteristic. 230 F.3d 1320, 1327 (Fed. Cir. 2000). According to the
court, “this is exactly the type of overreaching the written description
requirement was designed to guard against.” Id.
Because Appellant’s Specification fails to provide written description
for “non-gelling composition” added by amendment, we find that claims 1,
6, 9–12, 17, 20, and 21 do not meet the written description requirement
under 35 U.S.C. § 112(a).
Definiteness under 35 U.S.C. § 112(b)
We also enter a new ground of rejection of claims 1, 6, 9–12, 17, 20,
and 21 as being indefinite under 35 U.S.C. § 112(b). In particular, we
determine that the claim term “non-gelling” as recited by the claims is
ambiguous and vague. See In re Packard, 751 F.3d 1307, 1312 (Fed. Cir.
2014).
“The standard of indefiniteness is somewhat high; a claim is not
indefinite merely because its scope is not ascertainable from the face of the
claims.” Amgen, Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313, 1342
(Fed. Cir. 2003). Rather, “[a] claim is indefinite if, when read in light of the
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specification, it does not reasonably apprise those skilled in the art of the
scope of the invention.” Id.
As discussed above, “non-gelling” is entirely absent from the
Specification, including the original claims as filed. There is no specific
definition of the term “non-gelling” in the Specification. Appellant
distinguishes the claimed composition from the gelling compositions of
Lichter, which contains at least about 5% poloxamer 407, optionally in
combination with not more than about 5% poloxamer 188 (¶¶ 59, 288-291),
and Williams which contains 0.1 to about 40% mucoadhesive, e.g.,
poloxamers 407 or 188 (Williams 12:31–26). Appellant does not explain or
define at what amount the claimed combination of up to 9% by weight
poloxamers ceases to form a gel or otherwise qualifies as “non-gelling.”
Accordingly, we determine that the claims, when read in light of the
specification, do not reasonably apprise those skilled in the art of the scope
of the invention, and thus are indefinite.

Conclusion
The Examiner’s rejection of claims 1, 6, 9–12, 17, 20, and 21 as
obvious under 35 U.S.C. § 103 is pro forma reversed.
We have also entered new grounds of rejection for claims 1, 6, 9–12,
17, 20, and 21 pursuant to 37 C.F.R. § 41.50(b). 37 C.F.R. § 41.50(b)
provides that “[a] new ground of rejection ... shall not be considered final for
judicial review.” 37 C.F.R. § 41.50(b) also provides that the Appellant:
WITHIN TWO MONTHS FROM THE DATE OF THE
DECISION, must exercise one of the following two options
with respect to the new ground of rejection to avoid termination
of the appeal as to the rejected claims:
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(1) Reopen prosecution. Submit an appropriate amendment of
the claims so rejected or new Evidence relating to the claims so
rejected, or both, and have the matter reconsidered by the
examiner, in which event the prosecution will be remanded to
the examiner . . . .

(2) Request rehearing. Request that the proceeding be reheard
under § 41.52 by the Board upon the same record . . . .

(emphasis added).
REVERSED
37 C.F.R. § 41.50(b)