DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/25/2026 has been entered.
Claims 23-42 are currently pending and under consideration.
Rejections Withdrawn in view of Applicants amendments:
The rejection of Claims 1-15, 17-18 and 21 under 35 U.S.C. 101 because the claimed invention is not directed to patent eligible subject matter for the reasons of record and incorporated herein is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-3, 5, 11-14, 17 and 19-21 under 35 U.S.C. 102(a)(1) as being anticipated by Riva et al. (Lancet Neurol 2019; 18: 155-164, IDS) as evidenced by Package leaflet: Information for the patient Sativex ® Oromucosal Spray (2025) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-3, 5-8 and 11-21 under 35 U.S.C. 102(a)(1) as being anticipated by Eyal, Aharon (US 2018/0169035 A1, 2018-06-21, IDS) referred to herein as Eyal is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 9 under 35 U.S.C. 103 as being unpatentable over Eyal, Aharon (US 2018/0169035 A1, 2018-06-21, IDS) referred to herein as Eyal, as applied to claims 1-3, 5-8 and 11-21 above, in view of Russo et al. (British Journal of Pharmacology (2011) 163, 1344-1364, IDS) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 10 under 35 U.S.C. 103 as being unpatentable over Eyal, Aharon (US 2018/0169035 A1, 2018-06-21, IDS) referred to herein as Eyal, as applied to claims 1-8 and 11-21 above, in view of Pellati et al. (Molecules 2018, 23, 2639, 1-21) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 10 under 35 U.S.C. 103 as being unpatentable over the combination of Farokhi et al. (US2020/0398184 A1, 2020-12-24, priority to 2018-08-08) in view of Russo, Ethan (Frontiers in Plant Science, (2019), 9, Article 1969, 1-8) referred to herein as Russo 2, as applied to claims 1-9, 11-18 and 21, in view of Pellati et al. (Molecules 2018, 23, 2639, 1-21) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 19-20 under 35 U.S.C. 103 as being unpatentable over the combination of Farokhi et al. (US2020/0398184 A1, 2020-12-24, priority to 2018-08-08) in view of Russo, Ethan (Frontiers in Plant Science, (2019), 9, Article 1969, 1-8) referred to herein as Russo 2, as applied to claims 1-9, 11-18 and 21, in view by Riva et al. (Lancet Neurol 2019; 18: 155-164, IDS) is withdrawn in view of Applicants amendments.
The rejection of Claims 1-3, 7, 11-16 and 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 11 and 12 of U.S. Patent No. 11,154,515 B2 to Biro and Russo (2021-10-26) in view of Russo and Guy (Medical Hypotheses (2006) 66, 324-246) is withdrawn in view of Applicants arguments.
The provisional rejection of Claims 1-3, 11 and 21 on the ground of nonstatutory double patenting as being unpatentable over claim 1-3 of copending Application No. 18/000,586 (reference application) is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 22 under 35 U.S.C. 103 as being unpatentable over Eyal, Aharon (US 2018/0169035 A1, 2018-06-21, IDS) referred to herein as Eyal, as applied to claims 1-3, 5-8 and 11-21 above, is withdrawn in view of Applicants amendment.
Rejections Maintained, but modified in view of Applicants amendments
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
New Claim(s) 30-36 are rejected under 35 U.S.C. 103 as being unpatentable over the Farokhi et al. (US2020/0398184 A1, 2020-12-24, priority to 2018-08-08) in view of Russo, Ethan (Frontiers in Plant Science, (2019), 9, Article 1969, 1-8) referred to herein as Russo 2.
Farokhi et al. teach a composition comprising a cannabis extract and a pharmaceutically acceptable carrier, diluent or excipient, wherein the composition is formulated for oral administration and/or transmucosal administration (Claims 23 and 24 of the PG Pub). With regards to the oral administration, Farokhi et al. teach that the compositions is a liquid, gel, tablet, gum, lozenge or a drop (Claim 25 of the PG Pub). With regards to transmucosal administration, Farakhi et al. teach that transmucosal administration encompasses oral formulations for buccal administration or aerosol sprays for nasal administration (paragraph 0148). With regards to the cannabis extract, Farakhi et al. teach that the extract is derived from Cannabis plant material including, but not limited to, Cannabis sativa or a hybrid thereof and includes at least one bioactive molecule comprising a cannabinoid, a flavonoid or a terpene (claim s 16 and 18 of the PG PUB). the administration comprises buccal administration or intra-nasal administration (claim 27 of the PG Pub). The PG Pub further teaches a number of cannabinoids such as THC, CBD, CBG, THCA, CBDA, as well as, a number of terpenes such as beta caryophyllene, alpha-pinene, D-limonene and linalool (beginning at paragraph 0048 to 0056). With regards to the terpenes, the PG Pub teaches that it is thought that interplay between the effects of cannabinoids and other compounds derived from Cannabis such as terpenes and/or flavonoids can enhance the efficacy of Cannabis extractions for the treatment of a variety of disorders or disease (0055). For example, Farakhi et al. teach that it is thought that the terpene myrcene can enhance penetration across the blood brain barrier, pinene can counteract memory or cognition problems, while the combination of pinene, myrcene and caryophyllene can help treat anxiety (0055). Lastly, Farakhi et al. teach that a person of ordinary skill will be able to select a Cannabis strain producing the desired terpenes for use with this extraction method (paragraph 0056).
Farakhi et al. does not specifically teach an extract comprising at least THC, CBD, CBG, THCA, CBDA, beta-caryophyllene, alpha-pinene, D-limonene, and linalool.
Russo 2 teaches that in 1998, Professors Raphael Mechoulam and Shimon Ben-Shabat posited that the endocannabinoid system demonstrated an “entourage effect” in which a variety of “inactive” metabolites and closely related molecules markedly increased the activity of the primary endogenous cannabinoids, anandamide and 2-arachidonoylglycerol, wherein this helped explain how botanical drugs were often more efficacious than their isolated components (page 4, 1st column, last full paragraph). Moreover, Russo 2 teach that recent data supports the possibility that cannabis preparation or single molecule may be too pure leading to reduced synergistic potential. For example, Russo teach that clinicians utilizing high -CBD Cannabis extracts to treat severe epilepsy demonstrated notable improvement in seizure frequency with doses far lower than those reported in formal clinical trials with Epidiolex, a 97% pure CBD preparation (Page 4, 2nd column last paragraph). In view of this, Russo 2 teach that such observations support the hypothesis of greater efficacy for Cannabis extracts, combining multiple anticonvulsant components, such as CBD, THC, THCA, THCV, CBDV, linalool and even caryophyllene (page 6, 1st column, 1st paragraph). Lastly, Russo 2 teaches an example of selective breading is illustrated in the form of a Cannabis chemovar named Caryodiol for its enhanced caryophyllene content and highly favorable THC:CBD ratio which portends to be applicable to treatment of numerous clinical conditions including pain, inflammation, fibrotic disorders, addiction, anxiety, depression, autoimmune diseases, dermatological conditions and cancer (page 6, 1st column, 1st full paraph). It is important to note that Caryodiol comprises THC, CBD, CBG, THCA, CBDA, beta-caryophyllene, alpha-pinene, D-limonene and linalool (page 5, figure 2)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to utilize an extract of the Cannabis strain referred to as Caryodiol in the composition taught by Farakhi et al. in view of the teachings of Russo 2. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
- Russo 2 teaches that a Cannabis chemovar named Caryodiol has enhanced caryophyllene content and highly favorable THC:CBD ratio which portends to be applicable to treatment of numerous clinical conditions including pain, inflammation, fibrotic disorders, addiction, anxiety, depression, autoimmune diseases, dermatological conditions and cancer.
In response to this rejection, Applicants contend (see page 13, when responding to claim 30) that Farokhi discloses a broad list of possible extract constituents and dosage forms. Regarding Russo 2, Applicants assert that Russo 2 discloses a natural Cannabis chemovar. However, Applicants assert that neither reference identifies the particular combination of THC, CBD, CBG, THCA, CBDA and beta-caryophyllene as a single pharmaceutical composition in one of the recited solid sublingual, buccal or oromucosal transmucosal dosage forms. Thus, Applicants contend that the Office’s reasoning would require selecting six active agents from broader prior-art disclosures and then selecting a specifically structured solid oral-mucosal dosage form is improper since the cited references do not identify a preferred combination, do not narrow the possibilities to a small or finite set and do not provide a composition-specific reason for making the claimed selection.
These arguments have been carefully considered, but are not found persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Farokhi et al. teach a composition comprising a cannabis extract and a pharmaceutically acceptable carrier, diluent or excipient, wherein the composition is formulated for oral administration and/or transmucosal administration. Farakhi et al. does not specifically teach an extract comprising at least THC, CBD, CBG, THCA, CBDA, beta-caryophyllene, alpha-pinene, D-limonene, and linalool However, Russo 2 teaches that a Cannabis chemovar named Caryodiol has enhanced caryophyllene content and highly favorable THC:CBD ratio which portends to be applicable to treatment of numerous clinical conditions including pain, inflammation, fibrotic disorders, addiction, anxiety, depression, autoimmune diseases, dermatological conditions and cancer. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to utilize an extract of the Cannabis strain referred to as Caryodiol in the composition taught by Farakhi et al. in view of the teachings of Russo 2. Moreover, it should be noted that the claims recite a pharmaceutical composition comprising which is open and does not exclude the presence of other ingredients. Lastly, as noted above, Russo 2 when discussing the “entourage” effect suggests that observations support the hypothesis of greater efficacy for Cannabis extracts, combining multiple anticonvulsant components, such as CBD, THC, THCA, THCV, CBDV, linalool and even caryophyllene. Accordingly, there does appear to be a suggestion in the art for combining the six (6) ingredients from the prior art.
Conclusion
Claims 23-29 and 37-42 appear to free of the prior art and are in condition for allowance.
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/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626
