Ex Parte Nagarkatti et alDownload PDFPatent Trial and Appeal BoardAug 31, 201813562750 (P.T.A.B. Aug. 31, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/562,750 07/31/2012 22827 7590 09/05/2018 DORITY & MANNING, P.A. POST OFFICE BOX 1449 GREENVILLE, SC 29602-1449 UNITED ST A TES OF AMERICA FIRST NAMED INVENTOR Prakash S. Nagarkatti 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 ATTORNEY DOCKET NO. CONFIRMATION NO. USC-104-DIV (601) 1042 EXAMINER MATOS NEGRON, TAINA DELMAR ART UNIT PAPER NUMBER 1621 NOTIFICATION DATE DELIVERY MODE 09/05/2018 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): USDOCKETING@DORITY-MANNING.COM PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PRAKASH S. NAGARKATTI AND MITZI NAGARKATTI 1 Appeal2017-009334 Application 13/562,750 Technology Center 1600 Before RICHARD M. LEBOVITZ, ULRIKE W. JENKS, and RICHARD J. SMITH, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims directed to a method of inducing apoptosis of thymocytes in a subject suffering from autoimmune hepatitis. The Examiner rejected the claims as obvious under 35 U.S.C. § 103. Appellants appeal the rejection pursuant to 35 U.S.C. § 134. We have jurisdiction under 35 U.S.C. § 6(b ). The rejection is affirmed. STATEMENT OF THE CASE Claims 1-5 and 20 stand finally rejected by the Examiner under 35 U.S.C. § 103(a) as obvious in view of Travis (U.S. Pat. No. 7,105,685 B2, 1 The Appeal Brief ("Br.") 1 lists the University of South Carolina, the assignee of record, as the real party in interest. Appeal2017-009334 Application 13/562,750 issued Sept. 12, 2006) ("Travis"), Mach et al. (WO 2006/024958 A2, published Mar. 9, 2006) ("Mach"), and Hampson et al. (U.S. Pat. No. 6,630,507 B 1, issued Oct. 7, 2003) ("Hampson"). Final Act. 3. Claim 1, the only independent claim on appeal, is reproduced below: 1. A method for inducing apoptosis of thymocytes in a subject suffering from autoimmune hepatitis, the method comprising administering to a subject an amount of cannabidiol greater than about 100 milligrams cannabidiol per kilogram mass of the subject, said cannabidiol being synthetic cannabidiol or natural cannabidiol isolated from other natural cannabinoids and is substantially free of Ll9-tetrahydrocannabinol, wherein upon administration of said cannabidiol, thymic cellularity of said subject decreases, and wherein said cannabidiol is administered to the subject substantially free of any psychotropic agent. REJECTION Claim 1 requires administering to a subject "suffering from autoimmune hepatitis ... an amount of cannabidiol [("CBD")] greater than about 100 milligrams cannabidiol per kilogram mass of the subject." It is not disputed by the Appellants that such administration would result in inducing apoptosis in the subject as required by the claim. The CBD is "substantially free of Ll9-tetrahydrocannabinol" ("THC") and "substantially free of any psychotropic agent." The claim also recites that the CBD is "synthetic cannabidiol or natural cannabidiol isolated from other natural cannabinoids." The Examiner cited Travis for teaching administration of cannabinol derivatives in the claimed amounts to a subject having an autoimmune disease. Final Act. 3. The Examiner found that the "cannabidiol [CBD] would necessarily be either one of synthetic cannabidiol or cannabidiol 2 Appeal2017-009334 Application 13/562,750 isolated from other [ cannabinoids]. Id. The Examiner found that Travis does not explicitly teach that the CBD is "substantially free of any psychotropic agent" or that the subject is "suffering from autoimmune hepatitis." Id. To meet these deficiencies, the Examiner further cited the disclosure in Mach directed to cannabinol compositions for treating autoimmune diseases, including autoimmune hepatitis. Id. The Examiner cited Hampson as teaching that CBD is not psychotropic and that non- psychotropic cannabinols "are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses." Id. at 4. The Examiner determined it would have been obvious to one of ordinary skill in the art to have utilized CBD to treat autoimmune hepatitis because Travis teaches the treatment of autoimmune diseases with CBD, and Mach teaches the same class of compounds and specifically discloses treatment of autoimmune hepatitis. Id. at 4--5. The Examiner reasoned that a person of ordinary skill in the art "would be motivated to use a composition substantially free" of THC because Hampson teaches "that compositions free of psychotropic substance and psyc[h ]oactive cannabinoids (THC) ... are particularly advantageous to use because they avoid toxicity and undesired psychoactive effects that are encountered with psychoactive cannabinoids at high doses." Id. at 5. DISCUSSION Appellants contend that the Examiner ignored the requirements of claim 1 that the claimed CBD is synthetic cannabidiol or natural cannabidiol isolated from other natural cannabinoids, substantially free of THC, and 3 Appeal2017-009334 Application 13/562,750 substantially free of any psychotropic agent. Br. 4---6. Appellants based this argument on the Examiner's statements in the Final Office Action as follows: It should also be noted that the instant claims do not recite a composition consisting of cannabidiol, a method consisting of administering cannabidiol or administering a composition which is free from delta 9 THC. Final Act. 8 ( emphasis added). As stated previously, the instant claims do not recite a method which consists of administration of cannabidiol or a method of administering a composition consisting of cannabidiol or a composition which does not contain delta 9-THC. Thus, in addition to suggesting substituting one cannabinoid for another (as set forth in the 103 rejection above), the art also suggests administering multiple cannabinoids. Since the instant claims merely require the cannabadiol is "isolated" from delta-9 THC, the claims do not exclude administering both compounds. Final Act. 8-9 ( emphasis added). Although, as indicated above, the Examiner stated that the claim does not exclude administering THC, it appears that the Examiner is addressing the limitation in claim 1 of "substantially free" of THC, permitting some THC to be administered. Nonetheless, the Examiner explicitly gave a reason for excluding THC from a composition administered to treat autoimmune hepatitis: A person of ordinary [ ] skill in the art would have been motivated to administer ... a cannabinoid composition comprising cannabidiol that is substantially free of THC because Mach et al. clearly implies [THC] is the major psychoactive component of marijuana and is a controlled substance because it has both sedative and depressant-like effects on cardiovascular and central nervous system. 4 Appeal2017-009334 Application 13/562,750 Furthermore, Hampson, is directed to the use of cannabinoids other than THC for therapeutic effect due to the undesirable psychotropic effect of THC. The skilled artisan therefore would have been motivated to exclude substantially all [THC] from the composition in light of the teachings of Hampson in combination with Mach et al. because it was understood to have toxicity issues and have undesirable psychoactive side effects. Therefore, Hampson provides motivation to one of ordinary skill in the art to improve upon the method disclosed by Mach et al. It would have been apparent to one of ordinary skill in the art that excluding or limiting [THC] would be advantageous due to the lack of undesired side effects. Final Act. 7 ( emphasis added). Thus, the Examiner did not ignore the limitations in claim 1 of administering cannabidiol "substantially free" of THC and of any psychotropic agent, but rather made specific findings of the obviousness of the claimed limitations. The Examiner's findings are supported by a preponderance of the evidence. For example, Hampson teaches: Cannabinoids have been found to have antioxidant properties, unrelated to NMDA receptor antagonism. This new found property makes cannabinoids useful in the treatment and prophylaxis of wide variety of oxidation associated diseases, such as ischemic, age-related, inflammatory and autoimmune diseases .... Nonpsychoactive cannabinoids, such as cannabidoil [ sp., cannabidiol], are particularly advantageous to use because they avoid toxicity that is encountered with psychoactive cannabinoids at high doses useful in the method of the present invention. Hampson, Abstract ( emphasis added). See also Final Act. 4. Thus, the Examiner had factual basis to conclude that it would have been obvious to one of ordinary skill in the art to have used a non- 5 Appeal2017-009334 Application 13/562,750 psychoactive cannabinoid to treat an autoimmune disease, particularly an agent free of THC, which is known to possess psychotropic activity. Travis also provides evidence of the obviousness of using a cannabinoid derivative "substantially free of any psychotropic agent." See Final Act. 4. Travis teaches: It is known in the art that some compounds according to Formula III are psychoactive, chiefly via agonism of the CB 1 receptor. [Thus], in some applications, it may be preferable to employ substituents within Formula III ... that preferably promote CB2 agonist activity, rather than CB 1 activity, and are more preferably substituents that promote selective CB2 agonist activity. In some embodiments, to mitigate or eliminate psychoactive effects attributed to some cannabinaoids [ sp. cannabinoids ], the inventive method employs a selective CB2 agonist, which is one that preferentially acts on the CB2 receptor, as opposed to the CB 1 receptor. Travis, col. 14, 11. 6-16. A CB2 agonist is non-psychoactive. Travis, col. 17, 11. 40-44. Thus, Travis teaches using a non-psychoactive cannabinoid to avoid psychoactive activity. With regard to Appellants' assertion that the Examiner ignored the limitation of claim 1 that the cannabidiol is "synthetic cannabidiol or natural cannabidiol isolated from other natural cannabinoids" (Br. 5), Travis was cited by the Examiner and Travis describes natural and synthetic cannabidiols (Travis, col. 17, 11. 59-col. 20, 1. 3). Appellants did not identify a specific deficiency in Travis regarding this limitation. Further, the Examiner found it obvious to administer cannabidiols alone since they were known to treat autoimmune diseases and lack deleterious psychotropic effects. Final Act. 8: 1-7. Hampson, as cited by the Examiner, describes administering a cannabidiol, which the Examiner reasonably found to be "cannabidiol being synthetic cannabidiol or natural cannabidiol isolated 6 Appeal2017-009334 Application 13/562,750 from other natural cannabinoids" as recited in claim 1. See Final Act. 4, 5. We have reviewed Hampson and Travis and find no deficiency in the Examiner's findings. Appellants simply made the contention, without specifically identifying where the disclosures are deficient. Does Mach teach away from claim 1? Appellants state that Mach teaches administration of THC at low dosages to avoid the psychotropic effects of THC, and uses THC in all its examples. Br. 8-9. Appellants contend: "As such, one of ordinary skill in the art looking to modify the teachings of Travis would be motivated to use [THC], not a cannabidiol that is substantially free from [THC] or another psychotropic agent." Id. at 9. Even if it is correct that Mach uses THC in all its examples, and prefers it, Mach has broader disclosure on using other cannabinoids: The invention provides methods of alleviating a symptom of an autoimmune or inflammatory disorder in a patient ( e.g., a human) suffering from, or predisposed to developing, the autoimmune or inflammatory disorder, by administering a cannabinoid composition that contains a cannabinoid or cannabinoid derivative and a pharmaceutically acceptable carrier. The cannabinoid is, for example, delta-9- tetrahydrocannabinoid. The cannabinoid or cannabinoid derivative is administered in a non-psychotropic dosage for the patient. Mach 2:14--20 (emphasis added). Mach also discloses that CBD is a cannabinoid. Id. at 5: 18-20. It is well-established that disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442 (CCPA 1971); Merck 7 Appeal2017-009334 Application 13/562,750 & Co v. Biocraft Laboratories, 874 F.2d 804, 807 (Fed. Cir. 1989) ("[A]ll disclosures of the prior art, including unpreferred embodiments, must be considered."). Thus, while THC may have been preferred by Mach, such preference does not denigrate the broader disclosures of other cannabinoids, including CBD. Mach, as acknowledged by Appellants, teaches administering THC in a non-psychotropic dosage. Br. 9. Thus, one of ordinary skill in the art would have recognized the advantages of administering a cannabinoid without psychotropic activity as described in both Travis and Hampson. The non-psychotropic cannabinoids of Travis and Hampson are being used for their known and expected function in treating an autoimmune disease. As held in KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398, 417 (2007): [I]f a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill . . . . [A] court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions. In addition, as found by the Examiner, Travis teaches treating diseases with compounds that lack psychoactive activity. Travis, col. 14, 11. 6-16 (reproduced above). Travis also teaches treating autoimmune disease. Id. at 23:36-37. Travis also teaches cannabidiol derivatives. Id. at col. 3, 1. 56. Thus, one of ordinary skill in the art, as found by the Examiner, would have recognized that autoimmune hepatitis, which is autoimmune disease, would be treated with a cannabidiol lacking psychoactive activity. Appellants contend: neither of the references teach or even suggest a method of treating hepatitis in a subject, when the subject is suffering from 8 Appeal2017-009334 Application 13/562,750 autoimmune hepatitis, with a cannabidiol is administered to the subject substantially free of any psychotropic agent. Br. 10. While this statement is correct, none of the publications relied upon by the Examiner have been cited as anticipating the claimed subject matter. Rather, Mach teaches treating autoimmune hepatitis (at 8:22-25), but not explicitly with cannabidiol "substantially free of any psychotropic agent." However, Mach teaches administering cannabinoids, such as THC, at dosages that avoid psychotropic activity, providing a reason to have turned to the compounds described in Hampson and Travis. Appellants contend: the Examiner would require administering a composition without the [THC] component that is specifically required by Mach, et al. to treat autoimmune hepatitis .... However, it is clear that such an attempted modification would effectively destroy the intended purpose of Mach, et al. Br. 10. Appellants are reading Mach too narrowly. The express purpose of Mach is to treat an autoimmune disease with a non-psychotropic dosage of cannabinoid. Mach 2: 14--20. Administering a cannabinoid lacking psychotropic activity to treat the same disorder does not destroy its treatment purpose. Rather, the modification is an improvement to Mach, using an alternative strategy to avoid the psychotropic effects of cannabinoids. Such modification is reasonably suggested by both Travis and Hampson which disclose non-psychoactive cannabinoids, including the treatment of autoimmune diseases. Travis, col. 23, 1. 37. 9 Appeal2017-009334 Application 13/562,750 Furthermore, Mach teaches "that the immunomodulatory effects of cannabinoids are mediated by the CB2 receptor expressed on immune cells." Mach 7:5----6. Indeed, Mach also teaches that "cannabidiol [CBD], a major cannabinoid derivative" had been used to treat an immune disorder in mice. Id. at 6: 14--24. Consistently, Travis also teaches CB2 agonists to eliminate psychoactive effects. Travis, col. 14, 11. 10-16. Thus, Mach itself reasonably suggests utilizing CB2 agonists which lack psychotropic activity, including CBD. An improvement suggested by the prior art is not a teaching away, particularly when the purpose of the prior art is not destroyed, but improved upon. SUMMARY For the foregoing reasons, the obviousness rejection of claim 1 is affirmed. Claim 2-5 and 20 fall with claim 1 because separate reasons for their patentability were not provided. See Br. 11. 37 C.F.R. § 4I.37(c)(l)(iv). TIME PERIOD No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv). AFFIRMED 10 Copy with citationCopy as parenthetical citation