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 .
Claim Rejections - 35 USC § 103
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0256411 to Aung-Din (“Aung Din”), and further in view of US 2009/0247619 to Stinchcomb (“Stinchcomb”), WO 2019/089583 A1 to May et al. (“May”, of record), US 10,278,951 to Newland (“Newland”), and US 2019/0142888 to Mojsa (“Mojsa”).
Claim intepretation
Applicant’s claim 1 and claim 14 limitation “for topical pain relief”, and of claim 18 “for targeted topical pain relief” is an intended use of the composition, which does not provide further structural support, and it is thus just an intended use of the composition, which is not given any patentable weight.
Rejection
Aung-Din discloses a method of topically administering a cannabinoid to a specific region, i.e., the back of the neck region at the hairline (BONATH), in order to bypass the blood-brain barrier and deliver the cannabinoid directly to the brain stem and/or trigeminal nerves, and a composition for doing the same, e.g. a cream, comprising a cannabinoid drug, such as for the treatment of pain. This is called topical regional neuro-affective therapy (“TRNA therapy”). (Abstract, [0010-0012]). Aung-Din discloses that such composition is effective in treating localized pain (e.g., lower back pain), and pain in general, to include neuropathic and neurogenic pain, radiculopathy pain, neuropathic pain associated with post-herpetic neuralgia, neuralgic head pain, post-episiotomy pain, joint pain, musculoskeletal pain, diabetic neuropathy, migraine, peripheral neuropathy, fibromyalgia. ([0011], [0019], [0020], [0106]), claim 27, Example 6). A person of skill in the art would know this to include both examples of chronic pain (e.g. back pain) and idiopathic pain (e.g. fibromyalgia). It is noted that back pain affects a region selected from joint, ligament, muscle, tendon or disk.
Aung-Din discloses various topical compositions, such an oil-based cannabidiol (CBD) composition in the form of a cream, having a CBD concentration of 0.75%, 1%, 1.5%, 2% and 3%, and DMSO (10%). (Example 3, [0220]). This discloses a cannabinoid component according to Applicant’s claimed range.
The cannabinoid may also be applied with another pain relieving analgesic composition, e.g., NSAID, aspirin. ([0020], [0117]).
The composition can also be in the form of a transdermal patch (an article of manufacture), a transdermal plaster, a transdermal disc, iontophoretic transdermal device, or the like. ([0182], [0189]). In certain embodiments, the transdermal delivery devices, as well as other transdermal delivery systems in accordance with the invention can be made in the form of an article such as a tape, a patch, a sheet, a dressing or any other form known to those skilled in the art. ([0183]). In such embodiments, the dose of cannabinoid drug(s) may be that which is sufficient to provide a therapeutically effective dose to the back of the neck (e.g., non-systemic dose) over the course of e.g., from about 1, 2, 3, 4, 5, 6 or 7 days. ([0182]). This constitutes disclosure of a kit.
See also para [0167] of Aung-Din, which discloses co-formulating a composition as in Example 3, further with a penetration enhancer:
[0167] One preferred topical formulation comprises the cannabinoid drug(s) in oil, together with a suitable amount of a penetration enhancer, dimethyl sulfoxide and a base. For example, such a formulation may include the CBD oil, and about 3 ml dimethyl sulfoxide in 30 g of base. The CBD can be incorporated at a concentration of, e.g., from about 0.5% to about 5% of the topical formulation in a preferred embodiment, and most preferably from about 1.5% to about 3% in a certain embodiment. The dose of such a formulation would be, e.g., from about 0.5 g to about 1 g applied topically on the back of the neck of the human patient.
Penetration enhancers and carriers include various vegetable oils, e.g. almond oil, which is a fatty component, per Applicant’s claims, as well as Viscoleo (which comprises coconut oil1, and is further Applicant’s elected fatty component) ([0204], ([0163], [0199], [0218]- Example 1). Aung-Din discloses as further suitable carrier materials for the composition water and glycerin (a compatibilizer, per Applicant’s claims). ([0180]). Claim 14 of Aung-Din discloses that the composition can be water-in-oil or oil-in-water emulsion. Example 1 discloses a topical formulation comprising 4 mg of CBD in 1 ml of Lipoderm® (i.e. 45), wherein the Lipoderm® comprises inter alia water, kernel oil, wheat germ oil and glycerin. ([0218])
Aung-Din discloses that penetration enhancers include DMSO ([0160]), and that the composition comprises “preferably 0.01 wt. % to 50 wt. % drug (i.e., cannabinoid drug(s) plus optional additional drugs as described herein), and about 0 wt. % to about 50.0 wt. %, preferably from about 1 wt. % to about 30 wt. % of a permeation enhancer composition, with the remainder of the composition comprising a carrier or vehicle.” ([0161]). Aung-Din also discloses that it is a permeation enhancer, and that the amount of a permeation enhancer according to the invention can be 2 to 25% by weight. ([0163], [0189]).
Aung-Din additionally discloses terpenoids in its composition. Per Aung-Din:
“[0081] Cannabis terpenoids (e.g., limonene, myrcene, .alpha.-pinene, linalool, .beta.-caryophyllene, caryophyllene oxide, nerolidol and phytol) share a precursor with phytocannabinoids, and are all 19quale and fragrance components common to human diets that have been designated Generally Recognized as Safe by the US Food and Drug Administration and other regulatory agencies. Terpenoids are quite potent, and affect animal and even human 19qualene when inhaled from ambient air at serum levels in the single digits ngM1-1. They display unique therapeutic effects that may contribute meaningfully to the entourage effects of cannabis-based medicinal extracts. Thus, in certain embodiments, the formulations and treatments of the present invention include an active drug component which comprises both a phytocannabinoid(s) and a terpenoid(s). Phytocannabinoid-terpenoid interactions may produce synergy with respect to treatment of pain, inflammation, depression, anxiety, addiction, epilepsy, cancer, fungal and bacterial infections (including methicillin-resistant Staphylococcus aureus).” (emphasis added, to designate at least six of Applicant’s specifically claimed terpenoids).
It is further noted that compounds such as .beta.-caryophyllene and phytol are essential oils.
Aung-Din further discloses as a cannabinoid of the formulation THC, and CBD and THC ratios that provide therapeutic effect. ([0067], [0070]). It also discloses than a cannabinoid according to the invention can be delta-8 THC. ([0077]). The cannabinoid or cannabinoid-containing composition is applied to the subject's skin in an amount and for a time sufficient to alleviate the symptoms, e.g., inflammation, pain and/or discomfort, that are associated with an injury. ([0021]). Based on that disclosure, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to specifically optimize the amounts and ratios of the active ingredients guided by the desire to optimize the therapeutic effect.
Aung-Dun also discloses an explicit rationale to optimize the amounts of carrier. “In certain preferred embodiments, the drug is included in a cream or gel or ointment in a concentration of, e.g., 1 mg drug/ml of carrier (e.g., Lipoderm). However, it is to be understood that one skilled in the art can increase the amount of carrier or change the carrier and maintain or improve efficacy of the topical formulation for TRNA therapy.” ([0161]).
Moreover, even though Aung-Din does not explicitly disclose Applicant’s claimed range of DMSO, cannabinoid compositions formulated with DMSO in the ranges claimed by Applicant are further disclosed in the art.
Newland discloses an aqueous composition consists essentially of: from about 1.0 to about 10.0 weight percent (wt. %) tetrahydrocannabinol (THC); from about 10.0 to about 50.0 weight percent (wt. %) dimethyl sulfoxide (DMSO); from about 20.0 to about 60.0 weight percent (wt. %) ethanol; and from about 20.0 to about 60.0 weight percent (wt. %) water, which is used for treating opiate dependency. (claim 3). Newland discloses that the composition can be used for pain management. (Examples 2 and 3).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to optimize the amounts of additional formulation ingredients, to include of DMSO, guided by the disclosure of Aung-Din alone or in combination with Newland. The skilled artisan would have been motivated to do so because Aung-Din discloses a topical cannabinoid composition for treating pain, which is co-formulated with all of Applicant’s claimed ingredients. It would have been further obvious to a person of skill in the art before the effective filing date of the claimed invention to optimize the ration of DMSO vis-à-vis the cannabinoid and other ingredients (compatibilizer, water, etc.), motivated by the desire to balance the solubility, penetration and efficacy characteristics of the composition. The skilled artisan would have been motivation to do so by the desire to optimize therapeutic efficacy and penetration of the active ingredient(s), while maintaining desirable stability, emollient effect, etc., and further since topical compositions of cannabinoids and DMSO in Applicant’s claimed ranges have already been disclosed in the art, as evidenced by Newland.
Aung-Din is not limited to just topical pain relief applied to the neck, as the reference explicitly provides. “In certain preferred embodiments, the method of treatment further comprises administering the cannabinoid drug(s) to other areas of the spine and/or peripheral nerves in addition to administration on or at the back of the neck.” ([0037]).
Thus, Aung-Din alone renders Applicant’s invention obvious.
Moreover, further motivation to use the composition of Aung-Din for topical pain relief, beyond just that applied to the neck region, is further found in view of Stinchcomb et al. (“Stinchcomb”).
Stinchcomb discloses cannabinoid-containing (e.g. CBD) compositions for topical administration for the treatment of diseases such as arthritis and osteoarthritis, and the symptoms associated thereof, such as inflammatory pain. (Abstract, [0002], [0014]), wherein the cannabinoid can be solubilized with DMSO. ([0041]). The composition can be a hydrogel in water ([0045], [0047]), and can be further co-formulated with essential oils ([0051]), and penetration enhancers and fatty components, such as propylene glycol and oleic acid. ([0017]).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Aung-Din with Stinchcomb in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been further motivated to do so since both Aung-Din and Stinchcomb disclose compositions of cannabinoids co-formulated with ingredients, as per Applicant’s claims, and their utility for topical application for the treatment of pain.
Aung-Din does not specifically disclose the amount of terpene.
May relates to formulations of THC and CBD, to specifically include in a ratio of 5:1, further comprising at least one terpene, where in the terpine is bisabolol (aka -bisabolol), myrcene, -caryophyllene, humulene, pinene, limonene, linalool, etc. (claims 1-3, 6, p. 3, ll. 16-20). Non-limiting examples of optional flavoring agents of fatty components of May can include . . . olive oil, peppermint oil (an essential oil). (p. 27, l. 31- p. 28, l. 8; p. 4, ll. 10-14; p. 15, l. 6). The formulation of May be used for topical or transdermal administration, as well as a skin patch, spray, hydrogel, etc. (claim 33, p. 27, ll. 3-4). May discloses numerous specific formulations of CBD, THC, and combinations of 2-4 terpenes (p. 37, ll. 19).
May discloses that any terpene can be in amount between 0.01% and about 25% or greater. (p. 24, ll. 18-23). This discloses an overlapping range with Applicant’s claims.
May also discloses that the amount of CBD or THC can be about 0.1 to about 100 mg/ml (i.e. about 0.01-10%) (p. 25, ll. 7-8), and that the terpenes can be about 2%-25% (p. 25, l. 33). (claims 30-32) This discloses an overlapping ratio of terpenoids to cannabinoids as in Applicant’s claims.
May discloses various uses of its composition, e.g. for the treatment of pain. (p. 34, ll. 16-25).
Although Aung-Din discloses a terpenoid, which meets Applicant’s claim 14 limitation of “at least one of a terpenoid or an essential oil”, assuming claim 14 were to be amended to just the latter, it is noted that additional art meets this claim limitation too.
Mojsa is directed to a topical composition for pain relief comprising phytocannabinoids and a carrier vehicle for the phytocannabinoids, which include tetrahydrocannabinol THC and cannabidiol CBD present in amounts up to 25%, delivered to a user's skin and/or lips to alleviate pain. (Abstract). Mojsa discloses and claims that the composition further includes essential oils and/or arnica oil. (claim 10).
Accordingly, it would have been obvious to a person of skill in the art before the effective filing date of the claimed invention to combine the teachings of Aung-Din, Newland, Stinchcomb, May and Mojsa in order to practice Applicant’s claimed invention with a reasonable expectation of success. The skilled artisan would have been motivated to do so because Aung-Din discloses a topical cannabinoid composition for topical administration with all of Applicant’s claimed ingredients, to include with overlapping amounts and ratios for most, and May further discloses optimizing the amount of the terpene component in topical cannabinoid concentrations, to include for use in overlapping treatment uses, such as pain.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,839,593. Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose compositions with overlapping ingredients, with the main difference being some broader ratios and ranges of ingredients in the instant claims. The presence of arnica in claim 16 is further an example of an essential oil, per Applicant’s claim 14.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,446,278. Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose compositions with overlapping ingredients, with the main difference being some broader ratios and ranges of ingredients in the instant claims.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,029,707. Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose compositions with overlapping ingredients, with the main difference being some broader ratios and ranges of ingredients in the instant claims.
Other relevant art
The Examiner also notes for the record the following cumulative prior art over which rejection were not made solely in view of its cumulative nature:
-US 2013/0274321
-US 2012/0264818
-US 2018/0064055
-US 2017/0266128
-US 9533942
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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/SVETLANA M IVANOVA/Primary Examiner, Art Unit 1627
1 https://en.wikipedia.org/wiki/Viscoleo
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