Andrew B. Glasnapp

Patent Trials and Appeals Board

Sep 5, 2019

13917292 - (D) (P.T.A.B. Sep. 5, 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.
13/917,292 06/13/2013 Andrew B. Glasnapp 47656/15-225 1035
135404 7590 09/05/2019
GableGotwals
1100 ONEOK Plaza, 100 West 5th Street
Tulsa, OK 74103-4217
EXAMINER
MATOS NEGRON, TAINA DEL MAR
ART UNIT PAPER NUMBER
1621
MAIL DATE DELIVERY MODE
09/05/2019 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 ANDREW B. GLASNAPP
(APPLICANT: PROFESSIONAL COMPOUNDING
CENTERS OF AMERICA (PCCA))
____________

Appeal 2019-001838
Application 13/917,2921
Technology Center 1600
____________

Before DONALD E. ADAMS, FRANCISCO C. PRATS, and
RACHEL H. TOWNSEND, Administrative Patent Judges.

ADAMS, Administrative Patent Judge.

DECISION ON APPEAL
This Appeal under 35 U.S.C. § 134(a) involves claims 1–3, 6, 7, 10,
14, 15, and 21–24 (Final Act.2 2). Examiner entered rejections under
35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.

1 Appellant identifies “Professional Compounding Centers of America
(PCC)” as the real party in interest (Appellant’s June 25, 2016 Appeal Brief
(App. Br.) 2).
2 Examiner’s January 24, 2018 Final Office Action.
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STATEMENT OF THE CASE
Appellant’s “disclosure relates in general to pharmaceutical
compositions, and more specifically to transdermal compositions including
phenoxybenzamine for treatment of neuropathic pain” (Spec. ¶ 3). Claims 1,
23, and 24 are representative and reproduced below:
1. A method of treating neuropathic pain, comprising applying
to skin an effective amount of a pharmaceutical composition
that comprises phenoxybenzamine and at least one permeation
enhancement composition consisting of 2% w/w of one or more
phospholipids.
(App. Br. 14.)
23. A method of treating neuropathic pain, comprising
applying to skin only once daily an effective amount of a
pharmaceutical composition for local effect that comprises
phenoxybenzamine and at least one non-liposomal permeation
enhancement composition consisting of 2% w/w phospholipids;
3% w/w one or more oils; 0.5% w/w one or more skin lipids;
and 2% w/w one or more butters.
(Id. at 16.)
24. A method of treating myofascial pain, comprising applying
to skin at myofascial trigger points an effective amount of a
pharmaceutical composition that comprises phenoxybenzamine
and at least one permeation enhancement composition.
(Id.)

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Grounds of rejection before this Panel for review:3
Claims 1, 6, 7, 14, 15, and 21 stand rejected under 35 U.S.C. § 103(a)
as unpatentable over the combination of Ali4 and Inchiosa.5
Claims 2, 3, 22, and 23 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ali, Inchiosa, Banov,6 and Grasela.7
Claims 10 and 24 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Ali, Inchiosa, Avrahami,8 and Gunn.9

ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?

3 We recognize the claim objections presented on this record (see Final Act.
11). These objections are petitionable rather than appealable issues.
Therefore, we do not address the merits of the objections presented on this
record. See Manual of Patent Examining Procedure § 1201 (“The line of
demarcation between appealable matters for the Board and petitionable
matters for the Director of the U.S. Patent and Trademark Office . . . should
be carefully observed.”)
4 Ali et al., US 2010/0068251 A1, published Mar. 18, 2010.
5 Inchiosa et al., Treatment of Compex Regional Pain Syndrome Type I With
Oral Phenoxybenzamine: Rationale and Case Reports, 8 PAIN PRACTICE
125–132 (2008)
6 Banov et al., US 2012/0202882 A1, published Aug. 9, 2012.
7 Grasela et al., US 5,837,289, issued Nov. 17, 1998.
8 Avrahami, et al., A randomized, placebo-controlled double-blinded
comparative clinical study of five over-the-counter non-pharmacological
topical analgesics for myofascial pain: single session findings, 20
CHIROPRACTIC & MANUAL THERAPIES 1–6 (2007).
9 Gunn, Treating Myofascial Pain, 3 AMERICAN ACADEMY OF MEDICAL
ACUPUNCTURE REVIEW 4-6 (1991).
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FACTUAL FINDINGS (FF)
FF 1. Ali discloses “methods of preparing active compounds complexed
with lipids using aqueous systems that are free of organic solvents, and
methods of using the complexes, e.g., in treating a disease in a subject” (Ali,
Abstract; see id. (Ali discloses “a method comprising preparing a
composition comprising a lipid complex comprising at least one active
compound and at least one lipid and administering the composition to a
subject”); id. ¶ 14 (Ali discloses “lipid formulations or complexes
comprising at least one active component and at least one lipid, e.g., a
phospholipid, formed without using organic solvent”); id. ¶ 36 (Ali’s
“composition . . . comprises complexes, liposomes, micelles, and/or vesicles
that have a diameter of about 20 microns or less”); see generally Final Act.
3; Ans.10 4).
FF 2. Ali discloses compositions comprising “a total lipid concentration or
proportion of from about 2.5% by weight to about 95% by weight,” wherein
in “particularly preferred embodiments, the composition comprises a total
lipid concentration of from about 10% by weight to about 90% by weight”
(Ali ¶ 32; see Final Act. 3; Ans. 4).
FF 3. Ali discloses:
Any suitable phospholipids can be used. For example,
phospholipids can be obtained from natural sources or
chemically synthesized. Examples of phospholipids that find
use in the present invention include phosphatidylethanolamine
(PE), phosphatidylglycerol (PG), phosphatidylserine (PS),
phosphatidylcholine (PC), phosphatidylinositol (PI),

10 Examiner’s October 23, 2018 Answer.
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phosphatidic acid (PA), sphingomyelin and the like, either used
separately or in combination.
(Ali ¶ 93; see Final Act. 4; Ans. 4.)
FF 4. Ali discloses that
drugs, active agents or therapeutic agents that find use in the
methods, compositions and systems of [Ali’s disclosure] . . .
include, e.g., agents that act on the peripheral nerves, adrenergic
receptors, cholinergic receptors, the skeletal muscles, the
cardiovascular system, smooth muscles, the blood circulatory
system, synaptic sites, neuroeffector functional sites, endocrine
and hormone systems, the immunological system, the
reproductive system, the skeletal system, the alimentary and
excretory systems, the histamine system and the central nervous
system.
(Ali ¶ 43; see Final Act. 3; Ans. 4.)
FF 5. Ali identifies “phenoxybenzamine” as a “[s]uitable active agent[]”
for use in methods, compositions and systems within the scope of its
invention (Ali ¶ 43; see Final Act. 3; Ans. 4).
FF 6. Ali discloses the use of an “effective amount” of active agent,
wherein Ali discloses that
the term “effective amount” refers to the amount of an active
composition (e.g., a pharmaceutical compound or composition
provided as a component in a lipid formulation) sufficient to
effect beneficial or desired results. An effective amount can be
administered in one or more administrations, applications or
dosages and is not intended to be limited to a particular
formulation or administration route.
(Ali ¶ 57; see Final Act. 4; Ans. 4.)
FF 7. Ali discloses that
the term “administration” refers to the act of giving a drug,
prodrug, or other active agent, or therapeutic treatment (e.g.,
compositions of the present invention) to a physiological
system (e.g., a subject or in vivo, in vitro, or ex vivo cells,
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tissues, and organs). Exemplary routes of administration to the
human body can be through the eyes (ophthalmic), mouth
(oral), skin (transdermal), nose (nasal), lungs (inhalant), rectal,
vaginal, oral mucosa (buccal), ear, by injection (e.g.,
intravenously, subcutaneously, intratumorally, intraperitoneally,
etc.) and the like. Administration may be in one or more
administrations, applications or dosages, and is not intended to
be limited to a particular administration route.
(Ali ¶ 60; see id. 18: Claim 20 (Ali discloses topical administration); id. ¶ 50
(Ali discloses that “[r]outes of delivery of the composition to the subject . . .
include . . . topical delivery”); see Final Act. 4; Ans. 4.)
FF 8. Examiner finds that Ali “does not explicitly teach treating
neuropathic pain such as fibromyalgia . . ., at least one permeation
enhancement composition consisting of 2% w/w of one or more
phospholipids . . ., and wherein at least one permeation enhancement
composition is homogenized” (Final Act. 4; see also Ans. 5).
FF 9. Inchiosa discloses the use of phenoxybenzamine for the treatment of
neuropathic pain syndromes (Inchiosa, Abstract; see Final Act. 4; Ans. 5).
FF 10. Inchiosa discloses the administration of phenoxbenzamine at a
dosage of 10 mg/day (Inchiosa 3: col. 1, ll. 5–6; see Final Act. 4; Ans. 5).
FF 11. Examiner finds that the combination of Ali and Inchiosa
do[es] not explicitly teach a pharmaceutical composition
comprises about 5 mg/g to about 120 mg/g and 15 mg/g
phenoxybenzamine . . ., 2% w/w of phospholipids, about 3%
w/w one or more oils, 0.5 % w/w one or more skin lipid,
2%w/w one or more butter and non-liposomal; permeation
enhancement.
(Final Act. 6; see also Ans. 7.)
FF 12. Banov discloses:
A composition to be used as a permeation enhancer . . . . The
composition may be added to topical cosmetics or
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pharmaceutical formulations that are topically applied. The
composition comprises about 0.05-5% w/w of one or more
phospholipids, 1-20% w/w of one or more oils having essential
fatty acids, behenic acid, and oleic acid, 0.1-3% w/w of one or
more skin lipids, and 1-10% w/w of a butter having linoleic
acid and linolenic acid. One of the oils used in the composition
is Pracaxi oil.
(Banov, Abstract (emphasis added); see id. ¶ 5; see also Final Act. 6; Ans.
7.)
FF 13. Banov discloses “a composition to be used for skin permeation”
(Banov ¶ 6; see Final Act. 6–7; Ans. 7).
FF 14. Banov discloses that when its composition
is prepared, liposomes are formed from the fatty acids,
including behenic acid and oleic acid that are present the one or
more oils, and are stabilized by the phospholipids in the
composition. More specifically, when the permeation enhancer
composition described herein is added to water or a water-
containing composition, liposomes are formed.
(Banov ¶ 19; see Final Act. 7; Ans. 7.)
FF 15. Grasela discloses:
A composition and procedures for its formation and
administration are described, which provide for a convenient,
efficacious and simple transdermal administration of
medications from a topically applied cream. No transmission
through a membrane is involved. The composition incorporates
at least two separate penetration enhancers which function
synergistically to provide for rapid but controllable transport of
the medication from the cream into the skin. The use of a
plurality of penetration enhancers, at least one of which
facilitates the separation of medication from the cream and at
least a second of which alters the structure of the outer layers of
skin, particularly the stratum corneum, enhances migration of
the drug through the stratum corneum.
(Grasela, Abstract; see Final Act. 7; Ans. 7–8.)
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FF 16. Grasela discloses that a medicament within the scope of its
disclosure includes phenoxybenzamine (Grasela 15:19; see Final Act. 7;
Ans. 8).
FF 17. Grasela discloses that “[t]he basic composition of [its] invention is a
mixture of an organogel, a solubilized medication or drug and a carrier
combined with a drug release agent,” wherein the “[p]enetration
enhancement is provided by the organogel and by the release agent”
(Grasela 5:46–49; see generally Final Act. 7; Ans. 8).
FF 18. Grasela discloses that “an organogel is formed, . . . [for] example
from lecithin and isopropyl palmitate,” the solvent may be “water, alcohol or
other appropriate solvent,” and the “drug release agent, [may be] . . . a
polyoxymer” (Grasela 5:51–65; see also id. at 6:9–14 (Grasela discloses that
“[t]he ‘lecithin component’ may be lecithin, any comparable fatty acid
phospholipid emulsifying agent, such as fatty acids and their esters,
cholesterol, tri-glycerides, gelatin, acacia, soybean oil, rapeseed oil,
cottonseed oil, waxes or egg yolk, or any other material which acts in the
same manner as lecithin.”); see generally Final Act. 7; Ans. 8).
FF 19. Grasela discloses:
The overall concentrations of the various components in
the composition will generally be in the ranges of:

(Grasela 16:57–65; see Final Act. 7; Ans. 8.)
FF 20. Examiner finds that the combination of Ali and Inchiosa “do[es] not
explicitly teach administering a pharmaceutical composition to myofascial
trigger points . . . and treating myofascial pain” (Final Act. 9).
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FF 21. Avrahami discloses a method of treating “Myofascial Pain Syndrome
(MPS) and Myofascial Trigger Point (MTRP),” by application of topical
analgesics, specifically “Ben-Gay Ultra Strength Muscle Pain Ointment
(BG), the Professional Therapy MuscleCare Roll-on (PTMC roll-on) and
Motion Medicine Cream (MM)” (Avrahami, Title and Abstract; see Final
Act. 9–10; Ans. 10).
FF 22. Gunn discloses:
Neuropathic pain that affects the musculoskeletal system is
commonly referred to as myofascial pain. Myofascial pain can
affect joints, muscles and their connective tissue attachments in
any part of the body. Because the clinical presentations of these
syndromes are remarkably diverse, they are customarily
regarded as separate and unrelated conditions and generally
labelled according to the location of the pain, e.g. lateral
epicondylitis, or Achilles tendonitis.
(Gunn 20; see Final Act. 10; Ans. 10.)
ANALYSIS
The rejection over the combination of Ali and Inchiosa:
Appellant’s claim 1 is representative.
Based on the combination of Ali and Inchiosa, Examiner concludes
that, at the time Appellant’s invention was made, it would have been prima
facie
obvious to develop a method of topically treating neuropathic
pain (i.e., fibromyalgia) by administering a pharmaceutical
composition comprising of phenoxybenzamine and at least one
permeation enhancement consisting of one or more
phospholipid because Ali . . . taught a topical pharmaceutical
composition comprising phenoxybenzamine and one or more
phospholipid lipids (i.e., permeation composition) that acts on
the central nervous system, synaptic sites and acts on peripheral

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nerves and lnchiosa . . . demonstrates that phenoxybenzamine is
used for the treatment of fibromyalgia (i.e., neuropathic pain).
(Final Act. 4–5; see also Ans. 5; FF 1–10.) In this regard, Examiner reasons
that the term “about” in Ali’s disclosure of a total lipid concentration of
“about 2.5%” broadens Ali’s disclosed range to an amount that touches or
overlaps Appellant’s claimed phospholipid range “of 2% w/w” (Final Act. 5;
see also Ans. 5–6). See In re Geisler, 116 F.3d 1465, 1469 (Fed. Cir. 1997)
(A claimed invention can be rendered prima facie obvious by a prior art
reference that discloses a range that touches the range recited in the claim.);
see also id. at 1468 (Overlapping ranges support a prima facie case of
obviousness).
“The meaning of the word ‘about’ is dependent on the facts of a case,
the nature of the invention, and the knowledge imparted by the totality of the
earlier disclosure to those skilled in the art.” Eiselstein v. Frank, 52 F.3d
1035, 1040 (Fed. Cir. 1995). On this record, Examiner reasons that the term
“‘about’ . . . provides some flexibility in allowing a lower limit that overlaps
with . . . [Appellant’s] claimed amount of phospholipid” (Ans. 13). See In re
Brandt, 886 F.3d 1171, 1177 (Fed. Cir. 2018 (quoting In re Patel, 566 Fed.
Appx. 1005, 1010 (Fed. Cir. 2014))) (an obviousness rejection “may be
appropriate ‘where there is a teaching in the prior art that the end points of
the prior art range are approximate, or can be flexibly applied’.”). See In re
Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“[A] prima facie case of
obviousness exists when the claimed range and the prior art range do not
overlap but are close enough such that one skilled in the art would have
expected them to have the same properties.”).
Thus, on this record, we find no error in Examiner’s conclusion that
because Ali provides “motivation and instruction to develop [a] topical
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pharmaceutical composition containing low amounts of phospholipid” a
person of ordinary skill in this art would have found it prima facie obvious
to optimize the amount of phospholipid in Ali’s topical pharmaceutical
composition (see Ans. 13). “[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).
For the foregoing reasons, we are not persuaded by Appellant’s
contention that “an increase of 2% to the 2.5% of the prior art is a 25% total
increase” and “no evidence of record suggests that a person of ordinary skill
in the art would consider a concentration variation of 25% to be about the
same” (App. Br. 5; see also id. at 5–6; Reply Br. 2–3). To the contrary, as
Examiner explains, Ali discloses the general conditions of Appellant’s
claimed invention and includes a suggestion to optimize the phospholipid
concentration in the composition (see Ans. 13).
We are not persuaded by Appellant’s contention that “Ali does not
teach that its lipids are employed in the context of a permeation enhancer as
[Appellant’s] claim 1 requires” (App. Br. 6). As Examiner explains,
Appellant’s claimed invention is not non-obvious in view of the combination
of Ali and Inchiosa simply because Appellant characterizes the
phospholipids as penetration enhancers (see Ans. 14). Identical language
between the prior art and claims is not required to sustain a prior-art
rejection. In re Skoner, 517 F.2d 947, 950 (CCPA 1975) (“Any other result
would permit the allowance of claims drawn to unpatentable subject matter
merely through the employment of descriptive language not chosen by the
prior art.”). Further, even if Appellant discovered that phospholipids in a
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composition disclosed by Ali acted as penetration enhancers, “the discovery
of a previously unappreciated property of a prior art composition, or of a
scientific explanation for the prior art’s functioning, does not render the old
composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco
Inc., 190 F.3d 1342, 1347 (Fed. Cir. 1999).
We are not persuaded by Appellant’s contention that Ali teaches away
from Appellant’s claimed invention because Ali’s “[p]referred embodiments
are taught to have ‘at least one’ phospholipid that is between 10% to 90%”
(App. Br. 6 (citing Ali ¶ 15); see also Reply Br. 3). See In re Lamberti, 545
F.2d 747, 750 (CCPA 1976) (a reference disclosure is not limited only to its
preferred embodiments, but is available for all that it discloses and suggests
to one of ordinary skill in the art).

The rejection over the combination of Ali, Inchiosa, Banov, and Grasela:
Appellant’s claim 23 is representative.
Based on the combination of Ali, Inchiosa, Banov, and Grasela,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious
to formulate a permeation composition comprising of a
phospholipid, one or more oil, one or more skin lipid and one or
more butter because Ba[]nov . . . taught the same elements in a
permeation enhancing composition suitable for adding one or
more active ingredients for topical delivery and assist with
penetration of active ingredient through the skin and Ali . . .
taught a pharmaceutical composition containing
phenoxybenzamine and lipids such as phospholipid and fatty
acids that can act in the central nervous system for topical
delivery.
(Final Act. 7–8; see also Ans. 8.)
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Ali’s “composition . . . comprises complexes, liposomes, micelles,
and/or vesicles that have a diameter of about 20 microns or less” (FF 1; see
also Ans. 15 (citing Ali ¶¶ 2 and 36) (Ali discloses “compositions
comprising active components or compounds, e.g., pharmaceutical
compounds, and lipids, including, e.g., complexes, micelles, emulsions,
liposomes or lipidic particle, and mixture of micelles and vesicles”)).
Therefore, we are not persuaded by Appellant’s contention that “Examiner
has not shown in Ali, or any other prior art, where non-liposomal
phospholipids are deployed” (App. Br. 8; see Reply Br. 4). As Examiner
explains, Ali “discloses that lipids include phospholipids and explicitly
taught the lipid can be use[d] in . . . a non-liposome form, thus one of
ordinary skill[] in the art would have found motivation and instruction from
Ali . . . to use a non-liposomal phospholipid in a topical composition” (Ans.
15). We find no error in Examiner’s reasoning.
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Examiner relied upon improper hindsight reasoning (see
App. Br. 8).

The rejection over the combination of Ali, Inchiosa, Avrahami, and Gunn:
Appellant’s claim 24 is representative.
Based on the combination of Ali, Inchiosa, Avrahami, and Gunn,
Examiner concludes that, at the time Appellant’s invention was made, it
would have been prima facie obvious
to administer a topical pharmaceutical composition to
myofascial trigger points for the treatment [of] pain because
Avrahami . . . demonstrates that administration of topical active
ingredients to a myofascial trigger point is a common therapy in
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pain. Taking the teachings of Ali et al. in combination with
lnchiosa . . . and Avrahami . . . the skilled artisan would have
had motivation to administer[] a pharmaceutical composition to
. . . at least one trigger point for the treatment and management
of neuropathic pain.
(Final Act. 10; see also Ans. 10–11.)
For the foregoing reasons, we are not persuaded by Appellant’s
contention that because Avrahami tested a product that
was both non-pharmacological and topical[,] . . . Examiner has
failed to provide any reasoning with respect to how
[Avrahami’s] teaching . . . is to be overcome such that one
would nevertheless rely on Avrahami’s teaching of use of a
wholly different type of composition in a manner claimed by
[Appellant].
(App. Br. 9–10; see also Reply Br. 5.) As Examiner explains,
The references cited are all directed to topical delivery and
treatment of neuropathic pain. Avrahami . . . [teaches] topically
administering a composition to myofascial trigger points is a
suitable method treatment for myofascial pain. Ali . . . in view
of lnchiosa . . . render obvious a topical pharmaceutical
composition having phenoxybenzamine and permeation
enhancers that is suitable for neuropathic pain treatment.
(Ans. 16.) We find no error in Examiner’s reasoning.
For the foregoing reasons, we are not persuaded by Appellant’s
contention that Examiner’s rational is “conclusory” or that “[n]othing in . . .
[Examiner’s rationale] (or elsewhere) explains why or how topical, non-
pharmacological treatments would positively teach anyone of ordinary skill
in the art to use a permeating pharmaceutical composition, even if the
condition being treated is the same” (App. Br. 10). Notwithstanding
Appellant’s contentions to the contrary, it is proper to “take account of the
inferences and creative steps that a person of ordinary skill in the art would
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employ.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 418 (2007). See also
id. at 421 (“A person of ordinary skill is also a person of ordinary creativity,
not an automaton.”).
CONCLUSION
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claim 1 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Ali and Inchiosa is affirmed. Claims 6, 7, 14, 15,
and 21 are not separately argued and fall with claim 1.
The rejection of claim 23 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Ali, Inchiosa, Banov, and Grasela is affirmed.
Claims 2, 3, and 23 are not separately argued and fall with claim 22.
The rejection of claim 24 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Ali, Inchiosa, Avrahami, and Gunn is affirmed.
Claim 10 is not separately argued and falls with claim 24.

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)(1)(iv).

AFFIRMED