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 .
Status of the Application
Claims 1-19 are pending and are examined herein.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,029,721.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a method of treating acute migraine pain in a subject in need thereof by administering a composition comprising CBD:THC in a weight ratio of 100:1 and in combination with a minor cannabinoid.
Claims 1-2, 4-6, 12-13, 16, 19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 17-18 of copending Application No. 17/429,259 (US Patent 12,708,631).
Both sets of claims recite a method of treating acute migraine pain in a subject in need thereof by administering a composition comprising CBD:THC in the claimed weight ratio.
Claims 1-2, 4-6, 8-19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-2, 5-20 of copending Application No. 18/581,224.
The referenced claims recite a method of pre-treating migraine pain in a subject in need thereof by administering a composition comprising CBD:THC in the claimed weight ratio, whereas the instant claims recite treating acute migraine pain. It would be obvious for one of ordinary skill in the art to treat acute migraine pain, since the referenced claims teach that the same claimed composition is useful for treating or pre-treating migraine pain, in general. This is a provisional obviousness-type double patenting rejection.
Claims 1-6, 8-11, 16, 19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-5, 12-25 of copending Application No. 18/739,002.
The referenced claims recite a method of treating hemiplegic migraine in a subject in need thereof by administering a composition comprising CBD:THC in the claimed weight ratio, whereas the instant claims recite treating acute migraine pain. Since hemiplegic migraine is a type of acute migraine, one of ordinary skill in the art would have expected treatment of acute migraine pain with a reasonable expectation of success. This is a provisional obviousness-type double patenting rejection.
Claims 1-2, 4-19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-16 of copending Application No. 19/339,926.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a method of treating acute migraine pain in a subject in need thereof by administering a composition comprising CBD:THC in a weight ratio of 100:1 and in combination with a minor cannabinoid. This is a provisional obviousness-type double patenting rejection.
Claims 1-2, 4-7, 16, 19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 7-9, 20 of copending Application No. 19/645,959.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a method of treating acute migraine pain in a subject in need thereof by administering a composition comprising CBD:THC in the claimed ratio. This is a provisional obviousness-type double patenting rejection.
Claims 1-2, 4-6, 12-13, 16, 19 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 4-10, 13, 16 of copending Application No. 19/696,196.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claims recite a method of treating acute migraine pain in a subject in need thereof by administering a composition comprising CBD:THC in the claimed ratio. This is a provisional obviousness-type double patenting rejection.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 112(b):
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 2 is rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Specifically, claim 2 recites the limitation "wherein the weight ratio" in claim 1. There is insufficient antecedent basis for this limitation in the claims.
Claim 3 is rejected under 35 U.S.C. 112(b) or 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Specifically, claim 3recites the limitation "wherein the administering" in claim 1. There is insufficient antecedent basis for this limitation in the claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham vs John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1, 3-19 are rejected under 35 U.S.C. 103(a) as being obvious over Bar-Lev Schleider (WO 2020/115750 A1, of record) in view of Kingsley et al. (US Patent Application 2019/0030170 A1, of record) and Baron et al. (“Patterns of medicinal cannabis use, strain analysis, and substitution effect among patients with migraine, headache, arthritis, and chronic pain in a medicinal cannabis cohort,” Journal of Headache and Pain, 2018, 19:37, of record).
The instant claims are directed to a method of treating migraine pain in a subject in need thereof by administering a composition comprising at least one minor cannabinoid in combination with THC and CBD, wherein the administering is accomplished via injection and the ratio of CBD to THC is between 30:1 to 300:1 mg/kg.
Bar-Lev Schleider teaches a method of treating headaches, acute migraines, and their related symptoms, such as nausea, vomiting, photophobia, and phonophobia (claims 12-17) by administering a cannabis-based composition in the form of an oil extract of the cannabis strain Erez (claims 20-21). Example 1 shows that Erez oil contains THC, CBG, and CBD. Therapeutic improvement can be evaluated according to severity scales by a physician or self-reported (page 7, paragraph 4). Immediate relief is meant to convey the efficacy of the composition in a timeframe up to 0.5, 1, 1.5, or 2 hours or more after administration (page 8, paragraphs 3-4).
However, Bar-Lev Schleider fail to disclose wherein the CBD:THC ratio is 30:1 to 300:1 mg/kg and injection administration.
Kingsley et al. teach cannabinoid formulations with improved solubility profiles (paragraphs 0009-0010) comprising THC and CBD and/or other cannabinoids, for example CBG (paragraph 0040) for use in the treatment of migraine headaches and related conditions (paragraph 0075). In one embodiment, the ratio of CBD to THC is 20:1 (paragraph 0040). The formulation is administered via injection (paragraphs 0013, 0021).
Baron et al. teach a study where a composition comprising 0.4% THC and 9% CBD treated chronic migraine (page 2, right column, last paragraph). Of the 540 phytochemicals in cannabis, THC and CBD have been the most researched. THC is the cause of the psychoactive side effects of cannabis (page 15). CBD has gained a lot of attention over the past several years due to its lack of any psychoactivity, as opposed to THC. CBD exhibits no evidence for abuse or dependence potential, and there is no evidence of public health related problems associated with the use of pure CBD. In January 2018, the World Anti-Doping Agency removed CBD from their prohibited list, no longer banning use by athletes. CBD appears to attenuate some of the negative side effects of THC when the CBD:THC ratio is at least 8:1, but may potentiate some of the THC side effects when the ratio is around 2:1 (paragraph 16, bridging paragraph). High CBD strains include Sativa or Indica strains that have been crossed with high CBD hemp strains with ratios of approximately 50:1 CBD:THC (page 18, left column, 4th paragraph).
It is noted that the limitations regarding the claimed time for the treatment to be effective, the claimed biomarkers that are modulated, and the claimed reduction of unwanted side effects or risk factors associated with THC are considered obvious because all elemental steps of the claims have been taught by the cited prior art. Therefore, these limitations will obviously occur in vivo because they are considered mechanisms of action when the same claimed patient population is administered in the same claimed active agents.
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, at the time the claimed invention was made, to have modified the cannabis-based composition comprising CBG, CBD, and THC for the treatment of migraine, as taught by Bar-Lev Schleider, to the CBD to THC ratio of 30:1, as taught by Kingsley and Baron et al.
A person of ordinary skill in the art would have been motivated to modify the ratio of CBD to THC to 30:1 because both Kingsley and Baron et al. teach cannabinoid compositions favoring high CBD ratios for use in treating the same disorders. In fact, some strains taught by Baron et al. include ratios as high as 50:1 CBD:THC. Baron et al. goes on further to teach that the advantage of using more CBD is due to its lack of psychoactivity, which inhibits the potential for abuse or dependence. Unlike THC, there is no evidence of public health related problems associated with the use of CBD. Since CBD attenuates some of the negative side effects of THC when the CBD:THC ratio is at least 8:1, it would be obvious to use high CBD to THC ratios, such as 50:1, with a reasonable expectation of success in treating migraines while minimizing the risk of any negative side effects.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
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/Yong S. Chong/Primary Examiner, Art Unit 1623
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