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 .
DETAILED ACTION
Claim Status
Claims 1-16 are pending.
Election/Restrictions
Applicant’s election without traverse of Group II, claims 4, 5, 9 and 14, drawn to a method of using a formulation of an allosteric modulator, in the reply filed on 17 Nov 2025 is acknowledged. Applicants also elected that the allosteric modulator is oleamide, the cannabinoid is CBDV, the compositional form is a beverage (understood as a drink as recited in the instant claims), the additive is a surfactant, the compound the composition is used after is tryptamine and the method of using the composition is for recreational use in response to the species election requirement.
Claims 1-3, 6-8, 10-13, 15 and 16 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 4, 5, 9 and 14 are under consideration to the extent of the elected species, i.e., that the allosteric modulator is oleamide, the cannabinoid is CBDV, the compositional form is a beverage (understood as a drink as recited in the instant claims), the additive is a surfactant, the compound the composition is used after is tryptamine and the method of using the composition is for recreational use.
Third-Party Submission
The third-party submission under 37 CFR 1.290 submitted on 06 Feb 2025 is being considered by the examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: in the prior-filed application, Application No. 63/207,183, the applicant failed to provide adequate written description support for claims 4, 5, 9 and 14. Accordingly, priority cannot be granted at this time, thus claims 4, 5, 9 and 14 are granted the filing date of Application No. 17/667,147 (02/08/2022).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application No. 17/667,147 and 63/207,183, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application 63/207,183 fails to provide support for the specific method of the claims. The prior application does not do not provide support for using the composition after the use of another compound such as tryptamines. Accordingly, claims 4, 5, 9 and 14 are not entitled to the benefit of the prior application.
Specification
The abstract of the disclosure submitted on 28 Apr 2024 does not commence on a separate sheet in accordance with 37 CFR 1.52(b)(4) and 1.72(b). A new abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text.
Claim Objections
Claim 5 is objected to because of the following informalities: “The method of claims 1” should have a singular “claim” as in “The method of claim 1.”
The current wording of claim 5 is difficult to read. The claim recites “the composition is used in” and then lists various items or delivery methods but not all are in the correct form. For example, “topically” should be written as an adjective and not an adverb.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claims 4, 5, 9 and 14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 4, 9,and 14, the phrase "such as" renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 4, 9 and 14 are indefinite for use of the phrase “but not limited to” as it is unclear what other species are contemplated by the claims.
Claim 5 is indefinite for use of the phrase “or other related methods” as it is unclear what other methods are contemplated by the claims.
Claim 5 is indefinite for the recitation of “the method of claims 1” as claim 1 is directed to a composition and not a method
Claims 4, 9 and 14 are indefinite for referring to components of the COMPOUND LIST in the specification. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted)
Claim Interpretation
Claim 4, 9 and 14 are directed to methods of recreationally using a composition comprising an allosteric modulator of oleamide (the elected species) after the use of a compound such as tryptamine (the elected species). Claims 9 and 14 further require a terpene/terpenoid and a cannabis extract or cannabinoid such as CBDV (the elected species). Claim 5 is directed to a method of using a composition comprising an allosteric modulator of oleamide (the elected species) in the form of a beverage/drink (the elected species).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kleidon (WO 2020/131921, published 25 June 2020) as evidenced by Chen et al. (Journal of Ethnopharmacology 263 (2020) 113144).
Kleidon teaches cannabinoid compositions for virtual and augmented reality experiences (title). Kleidon teaches that the composition can be used for one or more entertainment or recreational applications ([0077]). Kleidon teaches a cannabidiol rich hot chocolate mix comprising optional superfood products such as reishi mushroom powder ([00211]). As evidenced by Chen, the gano oil of reishi contains oleamide (page 4 right column).
Kleidon does not expressly teach selecting the reishi mushroom in a drink for recreational use with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have used a hot chocolate mix comprising reishi mushroom (which contains oleamide) in a recreational use. One of ordinary skill in the art would have been motivated to do so as reishi mushroom in hot chocolate mix are taught by Kleidon as suitable in a method of using cannabinoid compositions for virtual and augmented reality experiences for recreational use. One of ordinary skill in the art would have a reasonable expectation of successfully using the hot chocolate mix comprising reishi mushroom as taught by Kleidon since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Kleidon.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bean et al. (US 2012/0027693, published 02 Feb 2012).
Bean teaches the prevention, treatment or amelioration of muscle cramps and/or accelerating nerve-muscle recovery from exercise fatigue using a composition with an activator of TRPV1 channels, an activator of TRPA1 channels, and/or an activator of ASIC channels ([0005]) where the composition is administered prior to, during, or following exercise ([0010]). Administering the composition as part of an exercise routine is understood to render obvious a recreational use. Bean teaches the composition may have one or more TRPV1 channel activators and that suitable TRPV1 channel activators include oleamide and a terpenoid with an alpha,beta-unsaturated 1,4 dialdehyde moiety ([0018]), [0023]). Bean teaches that the composition may be a beverage ([0018]).
Bean does not expressly teach selecting oleamide and a terpenoid in a beverage composition as part of the exercise routine with sufficient specificity to rise to the level of anticipation.
However, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention to have administered oleamide and a terpenoid with an alpha,beta-unsaturated 1,4 dialdehyde moiety in a beverage form as part of an exercise routine for the treatment or amelioration of muscle cramps and/or accelerating nerve-muscle recovery from exercise fatigue. One of ordinary skill in the art would have been motivated to do so TRPV1 channel activators such as oleamide and beverage forms are taught by Bean as suitable in a method for treating muscle cramps and accelerating nerve-muscle recovery. One of ordinary skill in the art would have a reasonable expectation of successfully treating muscle cramps and accelerating nerve-muscle recovery as taught by Bean since the modification of the prior art represents nothing more than the predictable use of prior art elements according to their established functions.
Accordingly, the instant claims are rendered prima facie obvious over the teachings of Bean.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Bean et al. (US 2012/0027693, published 02 Feb 2012) as applied to claim 5 above and in view of Gillessen et al. (WO 2005/039546, published 06 May 2005).
The teachings of bean are described supra.
Bean does not teach administration after a compound such as tryptamine. This deficiency is made up for in the teachings of Gillessen.
Gillessen teaches compounds capable of increasing serum level of insulin-like growth factor 1 for the treatment of conditions such as fatigue and for recovery after exercise (page 1). Gilesson teaches suitable compounds for the method include tryptamine (page 5).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered a composition comprising tryptamine in addition to the composition comprising oleamide rendered obvious from the teachings of Bean. Similar to oleamide, tryptamine is known for aiding in exercise recovery from the teachings of Bean and it would be obvious to administer compositions of each component for the purpose of aiding recovery after exercise. Similar uses, namely improving recovery from exercise, are known for tryptamine and oleamide and it would be obvious to administer compositions of each for the purpose of improving exercise recovery. Regarding the limitation that the oleamide composition is administered after the use of tryptamine, the examiner notes that Selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results, In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Bean et al. (US 2012/0027693, published 02 Feb 2012) in view of Gillessen et al. (WO 2005/039546, published 06 May 2005), as applied to claims 4 and 5 above, and further in view of Vialpando et al. (WO 2020/234675, published 26 Nov 2020).
The teachings of Bean and Gillessen are described supra. Bean further teaches that additional therapeutic agents may be administered with compositions of the invention ([0115]). Bean teaches combining with additional therapeutics for muscle cramps and muscle recovery and with sleep aids ([0115], [0116]).
Bean and Gillessen do not teach the inclusion of a cannabinoid such as CBDV (the elected species). These deficiencies are made up for in the teachings of Vialpando.
Vialpando teaches cannabinoid compositions (title) for use in treatment of a condition responsive to a cannabinoid ([039]) such as a sleep disorder ([040]). Suitable cannabinoids for the invention include CBDV ([011]) and the composition may be in the form of a beverage ([036]). Vialpando further teaches combination with terpenoids ([015]).
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have included a cannabinoid such as CBDV in the composition comprising oleamide and a terpenoid. The oleamide/terpenoid composition is used for recovery from exercise and may be combined with additional agents such as sleep aids, as taught by Bean. Cannabidioals such as CBDV are known to be suitable in beverage compositions and in combination with terpenoids and for use in treating sleep disorders, as taught by Vialpando. Thus, it would have been obvious to include a cannabinoid such as CBDV in the oleamide composition for its use in treating sleep disorders, which will aid the user in recovery after exercise. The oleamide compositions of Bean are known for combination with sleep aids and one would have a reasonable expectation of success in combining CBDV as it is known for use with sleep disorders and with beverage compositions and in combination with components such as terpenoids.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references.
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.
Claim 4, 5, 9, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/625,131 (reference application) in view of Bean et al. (US 2012/0027693, published 02 Feb 2012).
Claim 1 of the ‘131 application recites a method of treating conditions such as anxiety by administering a composition comprising components such as oleamide and tryptamine and cannabidiol and terpenoids (claim 4).
The method of the instant claims is broad in merely reciting a “method of using the composition of claim” 1, 7 or 12. Instant claim 1 recites a use for treating conditions such as anxiety and thus the ‘131 application renders obvious the method of using as in the instant claims.
The ‘131 application does not recite a composition in the form of a beverage. This deficiency is made up for in the teachings of Bean.
The teachings of Bean are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the oleamide composition of the reference application in the form of a beverage as this is an administration method known to be suitable for delivering components such as oleamide, thereby providing one of ordinary skill a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 9, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/625,137 (reference application) in view of Bean et al. (US 2012/0027693, published 02 Feb 2012).
Claim 1 of the ‘137 application recites a method of treating symptoms of stimulant use disorder by administering a composition comprising components such as oleamide and tryptamine and cannabidiol and terpenoids (claim 4).
The method of the instant claims is broad in merely reciting a “method of using the composition of claim” 1, 7 or 12. Instant claim 1 recites a use for treating conditions such as substance abuse and thus the ‘131 application renders obvious the method of using as in the instant claims.
The ‘137 application does not recite a composition in the form of a beverage. This deficiency is made up for in the teachings of Bean.
The teachings of Bean are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the oleamide composition of the reference application in the form of a beverage as this is an administration method known to be suitable for delivering components such as oleamide, thereby providing one of ordinary skill a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4, 5, 9, and 14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/625,181 (reference application) in view of Bean et al. (US 2012/0027693, published 02 Feb 2012).
Claim 1 of the ‘181 application recites a method of treating conditions opiate dependency by administering a composition comprising components such as oleamide and tryptamine and cannabidiol and terpenoids (claim 4).
The method of the instant claims is broad in merely reciting a “method of using the composition of claim” 1, 7 or 12. Instant claim 1 recites a use for treating conditions such as substance abuse and thus the ‘181 application renders obvious the method of using as in the instant claims.
The ‘181 application does not recite a composition in the form of a beverage. This deficiency is made up for in the teachings of Bean.
The teachings of Bean are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the oleamide composition of the reference application in the form of a beverage as this is an administration method known to be suitable for delivering components such as oleamide, thereby providing one of ordinary skill a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/625,187 reference application) in view of Bean et al. (US 2012/0027693, published 02 Feb 2012).
Claims 1 and 5 of the ‘187 application recites a method of treating symptoms of ingestion of drugs such as anxiety by administering a composition comprising components such as oleamide and CBDV and terpenoids (claim 7).
The method of the instant claims is broad and only refers to the method of claim 1. Instant claim 1 recites a use for treating conditions such as anxiety and treating substance abuse and thus the ‘187 application renders obvious the method of use as in the instant claims.
The ‘187 application does not recite a composition in the form of a beverage. This deficiency is made up for in the teachings of Bean.
The teachings of Bean are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the oleamide composition of the reference application in the form of a beverage as this is an administration method known to be suitable for delivering components such as oleamide, thereby providing one of ordinary skill a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/625,194 (reference application).
Claim 1 of the ‘194 application recites a method of reducing symptoms of the ingestion of drugs such as hallucination and anxiety conditions by administering a composition comprising components such as oleamide, CBDV (claim 4) and terpenoids (claim 6) in a beverage composition.
The method of the instant claims is broad and only refers to the method of claim 1. Instant claim 1 recites a use for treating conditions such as substance abuse and anxiety and thus the ‘194 application renders obvious the method of using as in the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 5 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/625,198 (reference application).
Claim 1 of the ‘198 application recites a method of increasing symptoms of the ingestion of drugs such as hallucinations and spiritual/mystical experiences by administering a composition comprising components such as oleamide and CBDV (claim 4) and terpenoids (claim 6) as a beverage.
The method of the instant claims is broad and only refers to the method of claim 1. Instant claim 1 recites a use for increasing spritual, psychonaut, mind exploring or recreational uses and thus the ‘198 application renders obvious the method of using as in the instant claims.
The ‘198 application does not recite a composition in the form of a beverage. This deficiency is made up for in the teachings of Bean.
The teachings of Bean are described supra.
Therefore, it would have been prima facie obvious to one of ordinary skill in the
art, before the effective filing date of the claimed invention to have administered the oleamide composition of the reference application in the form of a beverage as this is an administration method known to be suitable for delivering components such as oleamide, thereby providing one of ordinary skill a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EDWIN C MITCHELL whose telephone number is (571)272-7007. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/E.C.M./Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600