CMPD LICENSING, LLC

Patent Trials and Appeals Board

Mar 2, 2021

2020002594 (P.T.A.B. Mar. 2, 2021)

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.
15/273,276 09/22/2016 Jay Richard Ray II 8138-83 (0318844) 4147
30448 7590 03/02/2021
AKERMAN LLP
P.O. BOX 3188
WEST PALM BEACH, FL 33402-3188
EXAMINER
MATOS NEGRON, TAINA DEL MAR
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
03/02/2021 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):
ip@akerman.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte JAY RICHARD RAY II
__________

Appeal 2020-002594
Application 15/273,276
Technology Center 1600
__________

Before ERIC B. GRIMES, FRANCISCO C. PRATS, and
LILAN REN, Administrative Patent Judges.

PRATS, Administrative Patent Judge.

DECISION ON APPEAL

Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the
Examiner’s decision to reject claims 8, 10, 12, and 13. We have jurisdiction
under 35 U.S.C. § 6(b).
We AFFIRM.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies CMPD Licensing LLC. as the real party
in interest. Appeal Br. 2.
Appeal 2020-002594
Application 15/273,276

2
STATEMENT OF THE CASE
The sole rejection before us for review is the Examiner’s rejection of
claims 8, 10, 12, and 13 under 35 U.S.C. § 103 as being unpatentable over
Goldstein,2 Dooley,3 and Herold.4 Ans. 3–10.
Appellant’s claim 8, the sole independent claim on appeal, is
illustrative and reads as follows:
8. A topical composition for treating a fungal skin condition
and associated inflammation made by a process comprising:
combining
(a) between approximately 3% and approximately
8% by weight itraconazole, or pharmaceutically
acceptable salt, ester, or derivative thereof;
(b) between approximately 0.5% and 2.5% by
weight fluticasone, or pharmaceutically acceptable salt,
ester, or derivative thereof;
(c) meadowsweet flower extract in a polyethylene
glycol ointment base; and
(d) polyethylene glycol 300 MW, NF liquid..
Appeal Br. A-2 (Claims Appendix).
DISCUSSION
The Examiner’s Rejection
The Examiner cited Goldstein as disclosing topical compositions, in
the forms of gels or creams, that include itraconazole as an antifungal
ingredient and fluticasone as an anti-inflammatory agent. Ans. 4. The

2 WO 2004/037197 A2 (published May 6, 2004).
3 US 2016/0022653 A1 (published Jan. 28, 2016).
4 D. A. Herold et al., Toxicity of Topical Polyethylene Glycol, 65
TOXICOLOGY AND APPLIED PHARMACOLOGY 329–335 (1982).
Appeal 2020-002594
Application 15/273,276

3
Examiner noted Goldstein’s disclosure that a variety of excipients, including
polyethylene glycols, were useful in its compositions. Id. The Examiner
found that Goldstein’s compositions differ from the compositions recited in
Appellant’s claim 8 in that Goldstein’s compositions do not include the
meadowsweet flower extract and polyethylene glycol recited in the claim.
Id. at 5.
The Examiner cited Dooley as disclosing that claim 8’s meadowsweet
flower extract (in the form of the Spira-Wash™ gel) and polyethylene glycol
300 MW were known in the art to be useful as viscosity-imparting agents for
drug-containing topical compositions in the form of gels or creams. Ans. 5.
Based on the combined teachings of Goldstein and Dooley, the
Examiner reasoned that it would have been obvious to use Dooley’s Spira-
Wash™ and polyethylene glycol as viscosity-imparting agents for
Goldstein’s topical antifungal/anti-inflammatory compositions. Ans. 6. In
particular, the Examiner reasoned that “[m]otivation to include the Spira-
WashTM Gel of Dooley et al. in the topical composition of Goldstein et al.
would have risen from the fact that Spira-Wash™ Gel is an excipient useful
in topical composition and is suitable to be mix[ed] with active agents to be
delivered topically.” Id.; see also id. at 9 (“In addition, the skilled artisan
would have been motivated to combine meadowsweet flower extract in PEG
ointment base and PEG 300 because Dooley et al. taught that both
components are used as viscosity agents.”).
The Examiner cited Herold as further evidence that it would have
been obvious to include the polyethylene glycol 300 MW of Appellant’s
representative claim 8 in Goldstein’s topical compositions. Specifically, the
Examiner cited Herold as disclosing the use of an animal model to study the
Appeal 2020-002594
Application 15/273,276

4
toxicity of polyethylene glycol from repeated topical applications. See Ans.
6, 9.
Analysis—Claim 8
[T]he examiner bears the initial burden . . . of presenting a
prima facie case of unpatentability. . . .
After evidence or argument is submitted by the applicant
in response, patentability is determined on the totality of the
record, by a preponderance of evidence with due consideration
to persuasiveness of argument.
In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992); see also In re Jung, 637
F.3d 1356, 1365 (Fed. Cir. 2011) (holding that requiring an applicant to
identify “reversible error” in an examiner’s rejection is consistent with long
standing Board practice).
In the present case, having carefully considered all of the evidence
and argument presented by Appellant and the Examiner, we are not
persuaded that Appellant has shown reversible error in the Examiner’s
conclusion of obviousness as to the composition recited in Appellant’s
representative claim 8.
As the Supreme Court has explained, “when the question is whether a
patent claiming the combination of elements of prior art is obvious,” the
relevant inquiry is “whether the improvement is more than the predictable
use of prior art elements according to their established functions.” KSR Int’l
Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007).
Here, it is undisputed that all of the ingredients in the composition of
Appellant’s claim 8 were known in the art to be useful in topical
compositions. And, Appellant does not identify any persuasive evidence
suggesting that the claimed combination of ingredients provides an
unpredictable result.
Appeal 2020-002594
Application 15/273,276

5
Specifically, Goldstein discloses “stable topical formulations
containing an antifungal agent and an anti-inflammatory steroid.” Goldstein
1. Goldstein discloses that, “[i]n one embodiment, the dosage form is one of
cream, ointment, gel and lotion.” Id. at 7.
Goldstein discloses that the useful concentration ranges for its
antifungal agent and anti-inflammatory steroid overlap the concentration
ranges of itraconazole and fluticasone recited in Appellant’s claim 8. See
Goldstein 7 (“Generally, the formulation will contain between 0.01 wt% and
5.0 wt% of an antifungal agent and between 0.01 wt% and 5 wt% of an anti-
inflammatory steroid agent.”).
As the Examiner found, moreover, Goldstein discloses that
itraconazole is useful as the antifungal agent, and fluticasone propionate is
useful as the anti-inflammatory steroid, in its topical compositions. See
Goldstein 4, 5.
We are unpersuaded by Appellant’s contention that the combination
of itraconazole and fluticasone recited in Appellant’s claim 8 would have
been unobvious because, given the number of antifungal and steroid
ingredients in the lists disclosed in Goldstein, a skilled artisan only had
0.38% chance in arriving at claim 8’s itraconazole/fluticasone combination.
See Appeal Br. 10–12; Reply Br. 4–5.
The fact that itraconazole and fluticasone propionate appear in longer
lists of useful ingredients does not negate Goldstein’s express disclosure that
itraconazole is useful as the antifungal agent, and fluticasone propionate is
useful as the anti-inflammatory steroid, in its topical compositions. As
explained by our reviewing court, that a reference “discloses a multitude of
effective combinations does not render any particular formulation less
Appeal 2020-002594
Application 15/273,276

6
obvious.” Merck & Co. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir.
1989) (species claim held obvious where it recited one of 1200 possible
combinations of embodiments disclosed by reference and where reference
suggested no preference for claimed embodiment).
Appellant also does not persuade us that the Examiner erred reversibly
in determining that it would have been obvious to include meadowsweet
flower extract in a polyethylene glycol ointment base, and polyethylene
glycol 300 MW, as recited in Appellant’s claim 8, in Goldstein’s topical
compositions. See Appeal Br. 13–15; Reply Br. 6–9.
As the Examiner found, and Appellant does not dispute, Appellant’s
Specification discloses that the “Spira-WashTM Gel” product is a
meadowsweet flower extract in a polyethylene glycol ointment base
encompassed by Appellant’s claim 8:
[T]he topical base Spira-Wash™ Gel . . . [is] marketed by
Professional Compounding Centers of America (PCCA),
Houston, TX. Spira-Wash™ Gel is a water miscible topical
base including a blend of Meadowsweet Flower Extract, which
is rich in phenolic compounds, salicylates, and flavonoids, in a
polyethylene glycol (PEG) ointment base. Spira-Wash ™ Gel is
a soft, adherent gel, which is easily water washable. It has
potential use in dermatologic formulations for different
applications, such as wound care, an occlusive agent, a topical
humectant or infection treatment.
Spec. 6
As the Examiner found, Dooley discloses pharmaceutical
compositions in the form of a “viscous liquid and semi-solid (e.g., gel,
cream, or emulsion) . . . for use in mucosal delivery (e.g., for rectal or
vaginal application),” the compositions containing “viscosity agents—
polyethylene glycol, methyl cellulose, and Spira-Wash Gel™ base.” Dooley
Appeal 2020-002594
Application 15/273,276

7
¶ 167; see also id. (“Note that Spira-Wash Gel™ is an extemporaneous
compounding base that contains polyethylene glycols and propylene glycol,
among other ingredients.”); see also id. ¶ 166 (table showing Spira-Wash
Gel™ as viscosity agent in Dooley’s sample #7 and polyethylene glycol 300
MW as a viscosity agent in Dooley’s samples #8, #9, and #10).
As the Examiner found, Goldstein discloses polyethylene glycol as a
useful solvent excipient in its topical compositions. See Goldstein 5.
Thus, to summarize, Goldstein discloses preparing its
antifungal/steroid compositions in the form of gels and creams, and also
discloses that a variety of excipients, including polyethylene glycols, are
useful in those compositions. Dooley, in turn, discloses that Spira-Wash
Gel™ and polyethylene glycol 300 are both useful as viscosity agents in
pharmaceutical compositions prepared in the form of gels and creams.
Given these teachings, we agree with the Examiner that a skilled
artisan had a good reason for, and a reasonable expectation of success in,
using both Spira-Wash Gel™ and polyethylene glycol 300 as viscosity
agents when preparing Goldstein’s antifungal/steroid compositions prepared
in the form of gels and creams. Appellant does not persuade us, therefore,
that the Examiner erred reversibly in concluding that the composition recited
in Appellant’s claim 8 would have been obvious. See KSR, 550 U.S. at 417
(“[W]hen a patent ‘simply arranges old elements with each performing the
same function it had been known to perform’ and yields no more than one
would expect from such an arrangement, the combination is obvious.”
(quoting Sakraida v. Ag Pro, Inc., 425 U.S. 273, 282 (1976))). In the
present case, Appellant does not identify any persuasive evidence suggesting
Appeal 2020-002594
Application 15/273,276

8
that claim 8’s composition produces unexpected results or has unexpected
properties.
We acknowledge, as Appellant contends, that Dooley’s compositions
are for treating psychiatric disorders (see Dooley, abstract), unlike
Goldstein’s antifungal compositions. Appeal Br. 13; Reply Br. 6–7.
Nonetheless, the fact that Dooley’s compositions are for treating psychiatric
disorders does not negate Dooley’s express disclosure that Spira-Wash
Gel™ and polyethylene glycol 300 are both useful as viscosity agents in
pharmaceutical compositions prepared in the form of gels and creams,
precisely the physical forms of the compositions taught in Goldstein.
Similarly, the fact that Dooley describes its gels and creams as being used
for mucosal application (see Appeal Br. 13–14; Reply Br. 7–8) does not
negate Dooley’s disclosure that both Spira-Wash Gel™ and polyethylene
glycol 300 are useful viscosity agents for preparing pharmaceutical gels and
creams, which, again, are the same physical forms as the pharmaceutical
compositions taught in Goldstein.
We acknowledge, as Appellant contends, that Dooley does not
disclose using Spira-Wash Gel™ and polyethylene glycol 300 together as
viscosity agents in its compositions. See Appeal Br. 14–15; Reply Br. 8–9.
Nonetheless, given Dooley’s disclosure that Spira-Wash Gel™ and
polyethylene glycol 300 are each useful as viscosity agents in
pharmaceutical compositions prepared in the form of gels and creams, a
skilled artisan would have reasonably inferred that the combination of the
two viscosity agents would also be useful for imparting viscosity to
pharmaceutical gels or creams, like those taught in Goldstein. See KSR, 550
U.S. at 418 (The obviousness analysis “need not seek out precise teachings
Appeal 2020-002594
Application 15/273,276

9
directed to the specific subject matter of the challenged claim, for a court
can take account of the inferences and creative steps that a person of
ordinary skill in the art would employ.”); see also id. at 421 (“A person of
ordinary skill is . . . a person of ordinary creativity, not an automaton.”).
Appellant also does not persuade us that Herold teaches away from
the composition recited in Appellant’s claim 8. See Appeal Br. 8–10; Reply
Br. 2–4.
We acknowledge Herold’s disclosure that one formulation tested
using its animal model included polyethylene glycol 300. See Herold 330
(“The PEG vehicle (Solu-Base) is a blend of three PEG fractions whose
average molecular weights are 300 (63%), 1000 (5%), and 4000 (32%).”).
We acknowledge Herold’s disclosure that the polyethylene glycol
300-containing vehicle by itself produced toxic reactions in the test animals,
similar to the drug-containing formulation:
In our studies, repeated topical application of a PEG-
based agent to open wounds in rabbits resulted in the same fatal
syndrome observed in burn patients treated with FSD
[nitrofurazone (0.2%) dispersed in a PEG vehicle]. Although
nitrofurazone and PEG may produce a combined
nephrotoxicity, PEG alone reproduced all of the findings seen
with the combination. This syndrome resulted from the
absorption of PEGs from the topical cream and their subsequent
oxidation to aldehydes and acids.
Herold 334 (emphasis added; citations omitted).
Ultimately, however, rather than stating that polyethylene glycol
should not be used in topical compositions, Herold discloses that “[t]he
findings in this study document the need to critically evaluate, in an
appropriate animal model, those topical medicaments that may be applied
routinely to injured or altered skin.” Herold 334.
Appeal 2020-002594
Application 15/273,276

10
We are not persuaded that Herold’s directive, that topical
medicaments routinely applied to injured or altered skin should be evaluated
using an appropriate animal, equates to a direct teaching that topical
pharmaceutical compositions should not contain any amount of polyethylene
glycol 300, even a small amount. To the contrary, as the Examiner
contends, despite Herold’s warning in 1982 about the potential toxicity of a
particular polyethylene vehicle composition, both Goldstein (published in
2004) and Dooley (published in 2016) expressly state that polyethylene
glycol is useful in gels and creams applied topically as well as mucosally, as
noted above. Appellant does not persuade us, therefore, that Herold teaches
away from including polyethylene glycol 300, or polyethylene glycol-
containing viscosity agents such as Spira-Wash Gel™, in Goldstein’s
pharmaceutical gel or cream compositions.
In sum, for the reasons discussed, Appellant does not persuade us of
error in the Examiner’s conclusion of obviousness as to Appellant’s claim 8.
We therefore affirm the Examiner’s rejection of claim 8 for obviousness
over Goldstein, Dooley, and Herold.
Analysis—Claims 10, 12, and 13
Appellant argues that the Examiner erred in concluding that the
compositions recited in Appellant’s claims 10, 12, and 13 would have been
obvious over Goldstein, Dooley, and Herold. Appeal Br. 15–17; Reply Br.
10–13.
We select Appellant’s claim 10 as representative of the grouping
including claims 10, 12, and 13. See 37 C.F.R. § 41.37(c)(1)(iv). Claim 10
reads as follows:
Appeal 2020-002594
Application 15/273,276

11
10. The topical composition made by the process of claim 8,
wherein the meadowsweet flower extract in a polyethylene
glycol ointment base and the polyethylene glycol 300 MW, NF
liquid are combined at a ratio between approximately 8:1 and
approximately 9:1 meadowsweet flower extract in a
polyethylene glycol ointment base to polyethylene glycol 300
MW, NF liquid.
Appeal Br. A-2 (Claims Appendix).
The Examiner found that arriving at the claimed ratios of polyethylene
glycol and Spira-Wash Gel™ for use in Goldstein’s antifungal/steroid
compositions would have been a matter of routine optimization, based on the
teachings in Dooley and Herold:
It is obvious from the prior art of Dooley et al. and Herold et al.
that the amounts of PEG 300 and SpiraWash™ gel can be used
to determine the viscosity of the composition. Generally,
differences in concentration or temperature will not support the
patentability of subject matter encompassed by the prior art
unless there is evidence indicating such concentration or
temperature is critical. “[W]here the general conditions of a
claim are disclosed in the prior art, it is not inventive to
discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456[](CCPA
1955) M[PEP] §2144.05 (II) (A).
Ans. 9.
Appellant does not persuade us that the Examiner erred reversibly in
concluding that the composition recited in Appellant’s claim 10 would have
been obvious to a skilled artisan.
As discussed above, because Dooley discloses that Spira-Wash Gel™
and polyethylene glycol 300 are both useful as viscosity agents in
pharmaceutical compositions prepared in the form of gels and creams, we
agree with the Examiner that a skilled artisan had a good reason for, and a
reasonable expectation of success in, using a combination including both
Appeal 2020-002594
Application 15/273,276

12
Spira-Wash Gel™ and polyethylene glycol 300 as the viscosity-imparting
agent when preparing Goldstein’s antifungal/steroid gels and creams.
Accordingly, for reasons similar to those discussed above, Appellant does
not persuade us that Herold teaches away from the composition recited in
claim 10, or that a skilled artisan would have been dissuaded from including
both Spira-Wash Gel™ and polyethylene glycol 300 in Goldstein’s
compositions. See Appeal Br. 16; Reply Br. 10–11.
Moreover, because the viscosity-imparting effects of Spira-Wash
Gel™ and polyethylene glycol 300 were known in the art (see Dooley
¶ 167), Appellant does not persuade us that the Examiner erred in
determining that the ratio of the two ingredients was a result-effective
variable that a skilled artisan would have routinely optimized. As explained
by our reviewing court, in situations such as the present one, “[w]here ‘the
difference between the claimed invention and the prior art is some range or
other variable within the claims . . ., the [applicant] must show that the
particular range is critical, generally by showing that the claimed range
achieves unexpected results.’” Iron Grip Barbell Co., Inc. v. USA Sports,
Inc., 392 F.3d 1317, 1322 (Fed. Cir. 2004) (quoting In re Woodruff, 919
F.2d 1575, 1578 (Fed. Cir. 1990)). In the present case, Appellant points to
no unexpected results or properties provided by the composition recited in
claim 10.
In sum, for the reason discussed, Appellant does not persuade us that
the Examiner erred reversibly in determining that the composition recited in
Appellant’s claim 10 would have been obvious. We therefore affirm the
rejection of claim 10 for obviousness over Goldstein, Dooley, and Herold.
Claims 12 and 13 fall with claim 10. 37 C.F.R. § 41.37(c)(1)(iv).
Appeal 2020-002594
Application 15/273,276

13

DECISION SUMMARY
In summary:
Claims
Rejected
35 U.S.C.
§
Reference(s)/Basis Affirmed Reversed
8, 10, 12,
13
103 Goldstein, Dooley,
Herold
8, 10, 12,
13

TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(1)(iv).

AFFIRMED