THERAPIX BIOSCIENCES LTD.Download PDFPatent Trials and Appeals BoardJul 27, 20212021001369 (P.T.A.B. Jul. 27, 2021) Copy Citation 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. Appeal 2021-001369 Application 15/570,118 3 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. Appeal 2021-001369 Application 15/570,118 4 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. Appeal 2021-001369 Application 15/570,118 5 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 Appeal 2021-001369 Application 15/570,118 6 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]. Appeal 2021-001369 Application 15/570,118 7 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. Appeal 2021-001369 Application 15/570,118 8 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 Copy with citationCopy as parenthetical citation