Professional Compounding Centers of America(PCCA)

Patent Trials and Appeals Board

Feb 10, 2020

13900323 - (D) (P.T.A.B. Feb. 10, 2020)

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.
13/900,323 05/22/2013 Chris V. Simmons 47640/15-209 2131
135404 7590 02/10/2020
GableGotwals
1100 ONEOK Plaza, 100 West 5th Street
Tulsa, OK 74103-4217
EXAMINER
BARSKY, JARED
ART UNIT PAPER NUMBER
1628
MAIL DATE DELIVERY MODE
02/10/2020 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 CHRIS V. SIMMONS and DANNY CARRERO
____________

Appeal 2019-005185
Application 13/900,323
Technology Center 1600
____________

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

KATZ, Administrative Patent Judge.

DECISION ON APPEAL
Appellant1 seeks our review, under 35 U.S.C. § 134(a), of the
Examiner’s decision to reject claims 17, 20–23, 25, 27–33, and 36–40.
(Appeal Brief filed Jan. 15, 2019 (“App. Br.”) 6.) We have jurisdiction
under 35 U.S.C. § 6(b). We AFFIRM, but designate our affirmance as a
new ground of rejection.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Parties in Interest as
Professional Compounding Centers of America and Best Pet Rx IP, Inc.
(See App. Br. 2.)
Appeal 2019-005185
Application 13/900,323

2
INTRODUCTION
Appellant’s Specification provides a method of treating otitis by
administering an otic pharmaceutical composition. (Specification dated May
22, 2013 (“Spec.”) ¶ 7.) The composition may include a poloxamer vehicle
and a variety of active pharmaceutical ingredients (API). (Id.) The
composition forms a liquid at room temperature and converts to a gel at
body temperature due to the poloxamer. (Id. ¶ 9.) The Specification
discloses the composition may include poloxamer 407, which converts from
liquid to gel at temperatures at about 64° F. (Id. ¶ 40.) The composition
may also include a combination of poloxamer 407 and poloxamer L-64. (Id.
¶ 41.) Poloxamer L-64 increases the composition’s gelation temperature to
about 85° F. Id.
Appellant’s claim 17 recites:
A method of treating otitis comprising administering an
otic pharmaceutical composition into the ear canal of an animal,
wherein the composition is a liquid when administered and
comprises

a) an active pharmaceutical ingredient (API); and

b) at least two poloxamers in a solvent, wherein the at
least two poloxamers are selected from a group
comprising poloxamer L-64 and poloxamer 407; and

wherein the otic pharmaceutical composition is converted
from a liquid to a gel at body temperature inside the ear canal of
the animal at about 85 degrees Fahrenheit.

(App. Br. 15.) Independent claims 39 and 40 include a concentration of 20–
30% poloxamer 407. (Id. at 19–20.)
Appeal 2019-005185
Application 13/900,323

3
The Examiner rejects the claims as follows:
Claims
Rejected
35 U.S.C. §  Basis Non-Final Office
Action
17, 20–23, 25,
27–33, 36–40
103 Lichter,2 Meadows3 6–11
17, 20–23, 27–28,
33, 39, 40
103 Lichter ’018,4 Meadows 11–15

ANALYSIS
Claims 17, 39, and 40 as obvious over Lichter and Meadows
The Examiner finds Lichter teaches a method of treating otitis media,
by administering an otic pharmaceutical composition into the inner or
middle ear. (Non-Final Office Action dated April 13, 2018 (“Non-Final
Act.”) 6.) The Examiner finds the composition contains an active agent and
10–40% of a thermoreversible polymer, specifically poloxamer 407. (Id.)
The Examiner finds Lichter teaches the composition undergoes a phase
transition between room temperature and body temperature, and the gelation
temperature may range from about 20–30° C. (Id. at 7.)
The Examiner finds “Lichter does not teach poloxamer 184 (i.e., L-
64).” (Id. at 8.) The Examiner finds that Meadows teaches synergistic
poloxamer mixtures for administering active agents. (Id. at 8–9.) The
synergistic mixtures result from differences between poloxamers,
particularly in the polyethylene oxide portion. (Id. at 9.) Specifically,
Meadows teaches a synergistic combination of poloxamer 407 and

2 Lichter et al., US 2013/0116210 A1, published May 9, 2013.
3 Meadows et al., US 8,460,644 B2, issued June 11, 2013.
4 Lichter et al., US 8,399,018 B2, issued Mar. 19, 2013.
Appeal 2019-005185
Application 13/900,323

4
poloxamer 188. (Id.) The Examiner finds Meadows teaches that poloxamer
184 would have been expected to result in a similar synergistic mixture
when combined with poloxamer 407, due to the differences between
poloxamer 407 and poloxamers 188 and 184. (See id.) The Examiner finds
“that merely substituting a combination of two poloxamer vehicles for
another would have a reasonable expectation of success in achieving
delivery of the claimed API in an efficient manner.” (Id. at 10.)
Appellant argues Lichter does not teach a poloxamer combination
including “L-64 (poloxamer 184).” (App. Br. 7.) Appellant argues,
therefore, that Lichter’s otic composition containing only poloxamer 407
would begin to gel at about 64° F. (Id.) Appellant argues that Meadows
also does not teach a specific mixture of P407 and L-64; however,
“Meadows at least mentions L-64 once (as poloxamer 184, see col. 6, line
12).” (Id. at 7–8.)
Appellant argues further that Meadows does not teach that poloxamer
combinations are synergistic with respect to adjusting gelation temperature.
(Reply Brief filed June 25, 2019 (“Reply Br.”) 4.) Rather, Meadows teaches
poloxamer combinations form synergistic mixtures for solubilizing drugs.
(Id.) Appellant argues Meadows further discloses a preference for
poloxamer mixtures that do not cause gelling. (Id. at 5, citing Meadows
9:1–7.) Accordingly, Appellant argues that the prior art as a whole does not
support the Examiner’s rationale for combining the references. (Id.)
We are not persuaded. Contrary to Appellant’s arguments, Lichter
expressly teaches combining poloxamer 407 with poloxamer 188 to
manipulate the gelation temperature of an otic composition. (Lichter ¶ 613.)
Appeal 2019-005185
Application 13/900,323

5
Lichter teaches an equation for estimating the “gelation temperature of
F127(P407)/F68(P188) mixture” as:
Tgel = –1.8(% F127) + 1.3(% F68) + 53
(Id. ¶ 616.) The equation teaches that adding poloxamer 188 increases the
gelation temperature. (See id.)
Lichter teaches a composition containing 20% poloxamer 407 and
10% poloxamer 188. (Id. ¶ 614, Table 5.) Lichter’s equation estimates a
gelation temperature of 30° C (86° F) for the composition containing 20%
poloxamer 407 and 10% poloxamer 188. (See id. ¶¶ 614, 616.) Therefore,
Lichter teaches an otic formulation containing poloxamer 188 and
poloxamer 407 that converts from a liquid to a gel at body temperature at
about 85° F.
Meadows teaches that there is little difference between poloxamer 188
and poloxamer 184. (See Meadows 6:9–15.) Therefore, a person of
ordinary skill in the art would have expected poloxamer 184 to share similar
properties with poloxamer 188 for increasing the gelation temperature in
combination with poloxamer 407. Because combining poloxamer 184 with
poloxamer 407 would have been expected to increase the gelling
temperature of Lichter’s otic compositions similar to the combination with
poloxamer 188, we sustain the Examiner’s rejection. “[W]hen a patent
claims a structure already known in the prior art that is altered by the mere
substitution of one element for another known in the field, the combination
must do more than yield a predictable result.” KSR Int’l Co. v. Teleflex Inc.,
550 U.S. 398, 416 (2007), citing United States v. Adams, 383 U.S. 39, 50-51
(1966). Because our reasoning differs from the Examiner’s, we designate
Appeal 2019-005185
Application 13/900,323

6
our affirmance as a New Ground of Rejection to provide Appellant a fair
opportunity to address these teachings and new position.
Appellant does not provide separate arguments for the rejection of the
dependent claims. (See App. Br. 6–12.) Accordingly, we affirm the
Examiner’s rejection of claims 17, 20–23, 25, 27–33, 36–40 as being
obvious under 35 U.S.C. § 103.

Claims 17, 39, and 40 as obvious over Lichter ’018 and Meadows
The Examiner finds Lichter ’018, similarly to Lichter, teaches treating
otitis with otic pharmaceutical compositions that convert from liquid to gel
at body temperature. (See Non-Final Act. 11–15.) The Examiner finds one
of ordinary skill would have combined the poloxamer 407 composition
taught by Lichter ’018 with poloxamer 184 in view of Meadows. (Id.)
Appellant presents the same arguments against Lichter ’018 and Meadows
as presented against Lichter and Meadows. (See App. Br. 12–13.)
Lichter ’018 teaches the same equation for estimating the increase in
gelation temperature by combining poloxamer 188 with poloxamer 407, as
discussed with respect to Lichter above. (Lichter ’018, 100:54–101:26.)
Accordingly, for the reasons set forth above, we affirm the Examiner’s
rejection of claims 17, 20–23, 27–28, 33, 39, and 40 as obvious over
Lichter ’018 and Meadows. Because our reasoning differs from the
Examiner’s, we designate our affirmance as a New Ground of Rejection to
provide Appellant a fair opportunity to address these teachings and new
position.

Appeal 2019-005185
Application 13/900,323

7
CONCLUSION
Upon consideration of the record and the reasons given, the rejection
of claims 17, 20–23, 25, 27–33, 36–40 under 35 U.S.C. § 103 is sustained.
In summary:
Claims
Rejected
35 U.S.C. §  Basis Affirmed Reversed New Grounds
17, 20–23,
25, 27–33,
36–40
103  Lichter, Meadows 17, 20–23,
25, 27–33,
36–40
17, 20–23,
25, 27–33,
36–40
17, 20–23,
27–28, 33,
39, 40
103  Lichter ’018,
Meadows
17, 20–23,
27–28, 33,
39, 40
17, 20–23,
27–28, 33,
39, 40
Overall
Outcome
17, 20–23,
25, 27–33,
36–40
17, 20–23,
25, 27–33,
36–40

We have entered a new ground of rejection for independent claim 31
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 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:
(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 proceeding
will be remanded to the examiner . . . .

Appeal 2019-005185
Application 13/900,323

8
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record.

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). See 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED
37 C.F.R. § 41.50(b)