THERAPIX BIOSCIENCES LTD.

Patent Trials and Appeals Board

Jul 27, 2021

2021001369 (P.T.A.B. Jul. 27, 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.
15/570,118 10/27/2017 Ascher SHMULEWITZ 14339.0002 1970
22852 7590 07/27/2021
FINNEGAN, HENDERSON, FARABOW, GARRETT & DUNNER
LLP
901 NEW YORK AVENUE, NW
WASHINGTON, DC 20001-4413
EXAMINER
RODRIGUEZ, RAYNA B
ART UNIT PAPER NUMBER
1628
NOTIFICATION DATE DELIVERY MODE
07/27/2021 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):
regional-desk@finnegan.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ASCHER SHMULEWITZ, ELRAN HABER, and
EPHRAIM BRENER1
Appeal 2021-001369
Application 15/570,118
Technology Center 1600
Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and
ULRIKE W. JENKS, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
pharmaceutical composition, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.

1 Appellant identifies the real party in interest as THERAPIX
BIOSCIENCES LTD. Appeal Br. 1. We use the word “Appellant” to refer to
“applicant” as defined in 37 C.F.R. § 1.42.
Appeal 2021-001369
Application 15/570,118

2
STATEMENT OF THE CASE
“The most notable cannabinoid is the phyto-cannabinoid Δ9-
tetrahydrocannabinol (THC), which is the primary psychoactive component
of the cannabis plant. THC . . . possess[es] activities as a psycho-active
agent, analgesic, muscle relaxant, anti-spasmodic, bronchodilator,
neuroprotective, anti-oxidant and anti-pruritic agent.” Spec. 1:27–31.
“N-acylethanolamines (NAEs) are lipid-derived signaling molecules.
. . . Examples of N-acylethanolamines include. . . N-Palmitoylethanolamine,”
or PEA. Id. at 3:8–11. “PEA has been shown to have anti-inflammatory, anti-
nociceptive, neuro-protective, and anti-convulsant properties.” Id. at 3:27–28.
“The present invention provides pharmaceutical compositions comprising
beneficial combinations of cannabinoids and N-acylethanolamines.” Id. at
4:13–14.
Claims 135–140, 143–146, and 148–156 are on appeal. Claim 135,
reproduced below, is illustrative:
135. A pharmaceutical composition comprising a
therapeutically-effective amount of at least one cannabinoid or
a salt thereof, and at least one N-acylethanolamine or a salt
thereof, wherein the at least one cannabinoid is
tetrahydrocannabinol (THC), and wherein the molar ratio
between the at least one cannabinoid and the at least one N-
acylethanolamine is between about 1:0.2 to about 1:2000.

The claims stand rejected as follows:
Claims 135–137, 143–146, 148–150, and 153–156 under 35 U.S.C.
§ 103 as being obvious over Calignano2 and Wallace3 (Final Action4 6) and

2 Calignano et al., US 2002/0173550 A1, published Nov. 21, 2002.
3 Wallace, US 6,949,582 B1, issued Sept. 27, 2005.
4 Office Action mailed Nov. 20, 2019.
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Claims 138–140, 151, and 152 under 35 U.S.C. § 103 as being
obvious over Calignano, Wallace, Weber,5 and Del Giorno6 (Final Action
9).
OPINION
Claims 135–137, 143–146, 148–150, and 153–156 stand rejected as
obvious over Calignano and Wallace, and claims 138–140, 151, and 152
stand rejected as obvious over the same references, further combined with
Weber and Giorno. The same issue is dispositive for both rejections.
The Examiner finds that “Calignano teaches a pharmaceutical
composition comprising at least one endogenous cannabinoid selected from
the group consisting or [sic] anandamide and palmitylethanolamide[7] for
treating pain (claim 1); [and] a pharmaceutical composition comprising
anandamide and palmitylethanolamide (claim 9).” Final Action 6. The
Examiner finds that “Calignano does not explicitly teach the cannabinoid is
the elected tetrahydrocannabinol (THC).” Id.
However, the Examiner finds that “Wallace teaches the
endocannabinoid ‘anandamide’ binds to CB1 cannabinoid receptors, and its
activity parallels, to a large extent, that of delta-9-THC” Id. The Examiner

5 Janet Weber et al., Tetrahydrocannabinol (Delta 9-THC) Treatment in
Chronic Central Neuropathic Pain and Fibromyalgia Patients: Results of a
Multicenter Survey, ANESTHESIOLOGY RESEARCH AND PRACTICE, Article ID
827290, pp. 1–9 (2009).
6 Rosaria Del Giorno et al., Palmitoylethanolamide in Fibromyalgia: Results
from Prospective and Retrospective Observational Studies, PAIN THER.
4:169–178 (2015).
7 The Examiner finds, and Appellant does not dispute, that
“[p]almitylethanolamide is equivalent to the elected palmitoylethanolamine
(PEA).” Final Act. 6.
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also finds that Wallace teaches a mixture of delta-9-THC and cannabidiol,
“wherein the delta-9-tetrehydrocannabinol (delta-9-THC) provides analgesic
and anti-inflammatory effects, and the Cannabidiol (CBD) provides potent
antioxidant, neuroprotective and anti-inflammatory effects, and also reduces
the psychoactive effect of the delta-9-tetrahydrocannabinol.” Id. at 7.
The Examiner concludes:
Since Calignano teaches a pharmaceutical composition
comprising at least one endogenous cannabinoid and palmityl-
ethanolamide, and since Wallace teaches the endocannabinoid
“anandamide” binds to CB1 cannabinoid receptors, and its
activity parallels, to a large extent, that of delta-9-THC . . . it
would have been prima facie obvious for a person of ordinary
skill in the art to substitute one functional equivalence (any
cannabinoid) for another (tetrahydrocannabinol) with an
expectation of success, since the prior art establishes that both
function in similar manner.
Id.
Appellant argues that “Calignano teaches compositions containing
endogenous cannabinoids and away from compositions containing
phytocannabinoids (such as tetrahydrocannabinol; ‘THC’) because of the
undesirable side effects associated with the latter.” Appeal Br. 2. Appellant
notes Calignano’s discussion of “negative properties associated with
marijuana and cannabinoids,” including dependency, sedation, and euphoria.
Id. at 4.
Appellant thus argues that “Calignano’s technical objective, as a
whole, is to provide a pharmaceutical composition having a mechanism for
stimulating CB1/CB2 receptors that is different from the mechanism of
action of phytocannabinoids in such a way as to eliminate the undesirable
addictive and psychotropic properties of the phytocannabinoids.” Id. at 5–6.
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Appellant continues that “[t]he solution provided by Calignano is a
pharmaceutical composition that avoids the use of phytocannabinoids
(which include THC) specifically by combining two endogenous, animal-
sourced cannabinoids, specifically, AEA [anandamide] and PEA.” Id. at 6.
Appellant thus argues that the Examiner erred in concluding that it
would have been obvious to replace the anandamide in Calignano’s
composition with THC because Calignano “teach[es] that endogenous
cannabinoids (such as AEA and PEA) and phytocannabinoids (such THC)
are not functionally equivalent in that the endogenous cannabinoids are
capable of interacting with CB1/CB2 receptors in a manner that avoids the
undesirable side effects commonly associated with phytocannabinoids.” Id.
We agree with Appellant that the Examiner’s conclusion that, it would
have been obvious to substitute THC for the anandamide in Calignano’s
composition, is not supported by a preponderance of the evidence of record.
Calignano discloses that “[t]he most active chemical compound of the
naturally-occurring cannabinoids is tetrahydrocannabinol (THC),” and
“[m]any beneficial pharmacological properties attributed to marijuana
include analgesia, lowering blood and intra-ocular pressure, and anti-emetic
activity.” Id. ¶ 4.
Calignano discloses, however, that “the negative properties associated
with marijuana and cannabinoids include dependency, psychological
distortions of perception, loss of short-term memory, loss of motor
coordination, sedation, and euphoria.” Id. “These addictive and psychotropic
properties of cannabinoids limit their therapeutic value.” Id. ¶ 5.
Calignano states that “[i]t would be beneficial to have an alternate
mechanism for stimulating CB1 and CB2 receptors in such a way as to
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eliminate the undesirable addictive and psychotropic properties of
cannabinoids.” Id. ¶ 6. To that end, Calignano discloses “pharmaceutical
compositions and methods that are capable of limiting the sensation of pain
experienced by a mammal without undesirable side effects.” Id. ¶ 8.
Specifically, Calignano’s “pharmaceutical composition compris[es] a
therapeutically effective amount of at least one member of the group
consisting of anandamide (‘AEA’), palmitylethanolamide (‘PEA’) and
derivatives thereof.” Id. ¶ 9. Calignano states that its “invention results in the
inhibition of pain signaling” and “achieves the above superior and desired
effects without the undesired dysphoric side effects and habit-forming
properties characteristic of centrally acting cannabimirnmetic [sic] or opiate
drugs.” Id. ¶ 13.
Wallace discloses that the endogenous cannabinoid “[a]nandamide
binds to CB1 cannabinoid receptors, and its activity parallels, to a large
extent, that of delta-9-THC.” Wallace 3:38–39. Wallace’s invention is “a
rapid-onset cannabinoid delivery topical liniment composition having
analgesic and anti-inflammatory properties,” comprising a cannabinoid
mixture that can include delta-9-THC, among other cannabinoids. Id. at
9:53–64.
Wallace discloses that,
[f]or example, the cannabinoid component may be a mixture of
the psychoactive cannabinoid [THC] and the non-psychoactive
cannabinoid Cannabidiol (CBD), wherein the [THC] provides
analgesic and anti-inflammatory effects, and the Cannabidiol
(CBD) provides potent antioxidant, neuroprotective and anti-
inflammatory effects, and also reduces the psychoactive effect
of the [THC].
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Id. at 11:15–26. See also claim 5 (topical composition comprising
cannabinoid mixture comprising THC, CBD, and other cannabinoids, where
THC provides analgesic and anti-inflammatory effects and CBD provides
antioxidant, neuroprotective, and anti-inflammatory effects and “reduc[es]
psychoactive effects of said” THC).
Thus, Calignano teaches “eliminat[ing] the undesirable and
psychoactive properties of cannabinoids” (Calignano ¶ 6), including THC,
by using a combination of endogenous compounds to provide pain relief
while Wallace teaches reducing the psychoactive effect of THC by using a
mixture of cannabinoids. In short, the cited references teach different ways
to avoid the negative effects of THC, but the Examiner has not pointed to
evidence showing that a skilled artisan would have expected the
combination of THC with palmitylethanolamide—which would result from
substituting THC for the anandamide in Calignano’s composition—would
similarly reduce or eliminate the psychoactive effect of THC.
The Examiner therefore has not shown, by a preponderance of the
evidence, that the composition of claim 135 would have been obvious to a
person of ordinary skill in the art based on Calignano and Wallace. With
regard to the rejection based on Calignano, Wallace, Weber, and Del Giorno,
the Examiner cited Weber and Del Giorno for disclosing limitations recited
in dependent claims 138–140, 151, and 152, but did not point to any
disclosure in those references that would make up for the deficiency in the
combination of Calignano and Wallace. We therefore reverse that rejection
for the reasons discussed above.
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DECISION SUMMARY
In summary:
Claim(s)
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
135–137,
143–146,
148–150,
153–156
103 Calignano, Wallace 135–137,
143–146,
148–150,
153–156
138–140,
151, 152
103 Calignano, Wallace,
Weber, Del Giorno
138–140,
151, 152
Overall
Outcome
135–140,
143–146,
148–156

REVERSED