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 Claims and Response to Restriction Requirement
Claims 1-15, 17-19 and 21-22 are pending as of the response filed on 03/27/2026. Claims 16 and 20 are cancelled. Applicant’s election of Group I claims 1-13 without traverse, in the response filed 03/27/2026 is acknowledged. Claims 14-15, 17-19 and 21-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-13 are examined herein.
Priority
This application is a 371 of PCT/US22/14296 filed 01/28/2022 and claims priority to PRO 63/143,347 filed 01/29/2021.
Applicant’s claim for the benefit of a prior filed application under 35 U.S.C. 119(e) or under 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. 119(e) as follows:
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 earlier-filed nonprovisional application or provisional application for which benefit is claimed). 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. 63/143,347 fails to provide adequate support and 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. The ‘347 application does not have support for the limitations of instant claims 10-13. Accordingly, claims 10-13 have an effective filing date of 01/28/2022, the subject matter of which is supported in the PCT application, PCT/US22/14296 and claims 1-9 have an effective filing date of 01/29/2021, the subject matter of which is supported in the ‘347 provisional application.
Information Disclosure Statement
The information disclosure statement submitted on 11/07/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The limitation “non-naturally occurring composition” is given the broadest reasonable interpretation since the instant specification does not define the term. “Non-naturally occurring composition” is interpreted to mean a composition that is at least synthetically produced, purified or isolated from an extract.
Moreover, the examiner notes that the term “about” is defined in the specification to refer to a value of anywhere between ±100% to ±0.1%. Therefore, any recitation of “about” in the claims has been interpreted accordingly, to have values encompassing wide variations (pages 12-13 of the instant specification).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more.
The instant claims recite a non-naturally occurring composition comprising a combination of tetrahydrocannabinol (THC) and limonene. The claims are directed to components that are derived from nature. Regarding the limitation drawn to a “non-naturally occurring composition”, given the broadest reasonable interpretation, the claim is drawn to a composition that is synthetically obtained, purified or isolated from an extract. The examiner notes that this is a product-by-process type claim. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113. In the instant case, the synthetically obtained THC and limonene are no different from the THC and limonene occurring in nature. Thus, the synthesis of naturally occurring compounds does not amount to an exception of the judicial exception, because synthesis, isolation or purification does not result in a product which is ‘markedly different’ from the naturally-occurring component. Neither is there anything contained in the non-naturally occurring composition that is markedly different than the judicial exception.
This judicial exception is not integrated into a practical application because the claims are drawn to a composition that at its broadest only comprises one or more naturally occurring substances. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite any additional elements beyond the claimed components THC and limonene. The recitation of a medium-chain triglyceride (MCT) oil (as in claim 13) further includes a product of nature. Moreover, the recitation of specific ratios of THC and limonene (as in claims 4 and 7), or specific amounts of THC and limonene (as in claims 5-6), or formulation as a gelcap, breath strip or oromucosal spray (as in claims 10 and 12), does not affect this analysis because it does not markedly change the characteristics of THC and limonene in the composition, and it continues to have the same properties in the composition as it did alone. The claims are not meaningfully limited to amount to significantly more than the judicial exception.
Thus, instant claims 1-13 are directed to a natural product and nothing more and are deemed patent ineligible subject matter.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 8-10 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raz et al. (WO 2020/136627 A1, 02 July 2020, hereinafter Raz, in the IDS).
Regarding instant claims 1-2 and 4, Raz teaches a therapeutic product comprising at least one synthetic cannabinoid (obtained by a process of processing hemp, chemical synthesis, biological synthesis, isolation from a plant source) blended with a primary terpene, with an enhanced therapeutic effect (Paras. [004]-[005]) (i.e., processed or non-naturally occurring). Raz teaches the product comprises a composition (Para. [0057]; Para. [0157]). Raz teaches embodiments wherein the cannabinoid comprises THC (Para. [0063]). Raz teaches embodiments wherein the primary terpene comprises limonene (Para. [0051]; Para. [0178]). Raz teaches an exemplary composition comprising THC and limonene (Para. [00271]).
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The above embodiment teaches THC : limonene present in a ratio of about 2:1 (2.85:1, to be precise). Given the broad variation of values in the instant specification for the limitation “about”, the disclosure of Raz meets the limitations of instant claims 1-2 and 4.
Regarding instant claim 5, Raz anticipates the non-naturally occurring composition of instant claim 1. Raz teaches the daily dose of the cannabinoid in the product to range from about 1 milligram to about 300 milligram in certain embodiments. This encompasses the about 1 mg to about 50 mg of THC recited in claim 5.
Regarding instant claims 8-9, Raz anticipates the non-naturally occurring composition of instant claim 1. Raz teaches the product comprises at least 5% by weight of a non-cannabinoid, non-terpene carrier (Para. [00172]). Raz teaches the carrier can be selected from a group that includes sesame oil (Para. [00173]). Thus, the disclosure of Raz anticipates the limitations of instant claims 8-9.
Regarding instant claim 10, Raz anticipates the non-naturally occurring composition of instant claim 1. Raz teaches the product in the form of a gel capsule (Para. [0038]; Para. [00168]). Thus, the disclosure of Raz anticipates the limitations of instant claim 10.
Regarding instant claims 12-13, Raz anticipates the non-naturally occurring composition of instant claim 1. Raz teaches the product in the form of sublingual oils, sprays (Para. [0038]; Para. [00168]). Thus, the disclosure of Raz anticipates the limitations of instant claim 12 drawn to oromucosal delivery (sublingual is a specific type of oromucosal delivery) and instant claim 13, wherein the oromucosal delivery comprises an oromucosal spray.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3 and 5-6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davidson et al. (US 2018/0344954 A1, 06 December 2018, hereinafter Davidson ‘954, in the IDS).
Regarding instant claims 1-3, Davidson ‘954 teaches a solution of 5 mg Δ9-tetrahydrocannabinol (Dronabinol THC-10015S) and 1 mg of limonene (Sigma-Aldrich 62118-1 ml) in 50 µl ethanol (Para. [0589]). Therefore, the disclosure of Davidson ‘954 anticipates a non-naturally occurring composition comprising THC and limonene, wherein the THC is synthetic THC, wherein the synthetic THC is dronabinol.
The disclosure of Davidson ‘954 further anticipates the limitations of instant claims 5-6, wherein the composition comprises between about 1 mg to about 50 mg THC (as in instant claim 5) and comprises between about 0.5 mg to about 25 mg limonene (as in instant claim 6).
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eades et al. (US 2020/0093787 A1, 26 March 2020, hereinafter Eades, in the IDS).
Regarding instant claims 1 and 12-13, Eades teaches compositions for administering cannabinoid (Abstract). Eades teaches an exemplary formulation in the form of an oral spray comprising THC, limonene and MCT oil (Para. [0020]; TABLE 1; Para. [0017]). Thus, the disclosure of Eades anticipates a non-naturally occurring composition (since the above composition is man-made) as in instant claim 1. Eades also anticipates the limitations of instant claims 12-13 drawn to a formulation for oromucosal delivery (oral spray) that comprises a medium-chain triglyceride (MCT).
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5-6 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spritos (US 2021/0023044 A1, 28 January 2021).
Regarding instant claim 1, Spritos teaches cannabinoid-based therapeutics (Abstract). Spritos teaches a pharmaceutical composition comprising tetrahydrocannabinol (THC) and one or more terpenes (Paras. [0003]-[0005]; Para. [0046]). Spritos teaches an embodiment wherein the one or more terpenes comprise δ-limonene (Para. [0058]; Paras. [0103]-[0105]). Spritos teaches an exemplary embodiment wherein the formulation is prepared from THC oil isolate by mixing with the desired terpene and other excipients (evidencing a non-naturally occurring composition) (Paras. [0140]-[0143]).
According to MPEP § 2131.02(III), “A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE DISCLOSURE”.
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681(CCPA 1962)). In the instant case, a composition as instantly claimed comprising THC and limonene can be clearly envisaged by a PHOSITA from the disclosure of Spritos. Therefore, Spritos anticipates the non-naturally occurring composition of instant claim 1.
Regarding instant claims 5-6, Spritos anticipates the non-naturally occurring composition of instant claim 1. Spritos teaches wherein the pharmaceutical composition comprises 1-50 mg of THC per dose (Paras. [0050]-[0053]). Spritos teaches the pharmaceutical composition comprises 0.1-5 mg δ-limonene per dose (which overlaps and falls within the instantly claimed range of limonene) (Paras. [0103]-[0105]). Therefore, Spritos anticipates the limitations of instant claims 5-6.
Regarding instant claims 8-9, Spritos anticipates the non-naturally occurring composition of instant claim 1. Spritos teaches the pharmaceutical composition comprises a pharmaceutically acceptable carrier, such as, glycerin (Paras. [0013]-[0014]; Paras. [0141]; TABLE 2). Therefore, Spritos anticipates the limitations of instant claims 8-9.
Regarding instant claims 10-11, Spritos anticipates the non-naturally occurring composition of instant claim 1. Spritos teaches the pharmaceutical composition is formulated as a gel capsule (Para. [0012]; Para. [0126]). It is evident from the rejection of instant claims 5-6, that the dosages of THC and limonene fall within the recited range in instant claim 11. Therefore, Spritos anticipates the limitations of instant claims 10-11.
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 3, 6-7 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Raz et al. (WO 2020/136627 A1, 02 July 2020, hereinafter Raz, in the IDS) as applied to claims 1-2, 4-5, 8-10 and 12-13 above, in view of Davidson et al. (WO 2016/001923 A2, 07 January 2016, hereinafter Davidson ‘923).
The teachings of Raz are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claim 3, Raz anticipates the non-naturally occurring composition of instant claim 1. Raz do not teach wherein the synthetic THC comprises dronabinol.
Davidson ‘923 teaches methods, devices and systems for controlled pulmonary delivery of cannabinoids as active agents (Pg. 1, Lns. 13-15; Pg. 9, Lns. 30-31). Davidson ‘923 teaches the pharmacologically active agents include Δ9-terahydrocannabinol (THC) (Pg. 10, Lns. 1-7). Davidson ‘923 teaches the use of cannabis flos containing 19.9% dronabinol (Δ9-THC) (Pg. 114, Lns. 26-29) in ground form (Pg. 115, Lns. 4-8). Davidson ‘923 teaches higher satisfaction score for inhalation of ground cannabis flos compared to smoking cannabis flos (FIG. 5).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Raz and Davidson ‘923, to have utilized dronabinol, as the synthetic form of THC, to arrive at the composition of the instant invention. The motivation being to provide higher satisfaction to the user/subject being treated.
Regarding instant claims 6-7 and 11, Raz anticipates the non-naturally occurring composition of instant claim 1 and instant claim 10. Raz do not teach the composition comprising between about 0.5 mg to about 25 mg limonene; wherein the composition of THC and limonene are present in specific amounts in the specified ratios as recited in instant claim 7; wherein the composition comprises specific amounts of THC and limonene as in instant claim 11.
Davidson ‘923 teaches combination of active agents that provide a synergistic effect, active agents that potentiate or attenuate one another or other active agents (e.g., alter the effective therapeutic window or therapeutic index of one-another), active agents that provide contradictory effect, and active agents that have counteractive but desired effects and need to be spaced apart (Pg. 131, Ln. 30 - Pg. 132, Ln. 6; Pg. 63, Lns. 12-26). Davidson ‘923 teaches an embodiment of combination treatment for attenuating THC-induced psychoactivity that includes a dose of 10-40 mg limonene administered by inhalation prior to, during or after inhalation of THC (Pg. 134, Lns. 13-18). Davidson ‘923 teaches the first agent and the second agent induce a desired effect synergistically (Pg. 11, Lns. 9-10).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Raz and Davidson ‘923, to have optimized the ratios and amounts of THC and limonene to arrive at the composition of the instant claims with a reasonable expectation of success. Raz teaches a non-naturally occurring cannabinoid composition that comprises THC and a primary terpene, limonene. Raz teaches an embodiment that discloses THC : limonene present in a ratio of about 2:1. Raz teaches the daily dose of the cannabinoid in the range from about 1 milligram to about 300 milligram. Davidson ‘923 teaches methods, devices and systems for controlled pulmonary delivery of cannabinoids as active agents. Davidson ‘923 teaches combination of active agents that provide a synergistic effect, potentiation, complementary advantages, counteractive effects. Davidson ‘923 teaches an embodiment of combination treatment for attenuating THC-induced psychoactivity that includes a dose of 10-40 mg limonene administered by inhalation prior to, during or after inhalation of THC.
Therefore, one of ordinary skill in the art would have been motivated to formulate a composition of THC and limonene is specified amounts and specified ratios to achieve an intended therapeutic effect. The motivation being to mitigate any undesired side effects of the main therapeutic, say, attenuate THC-induced psychoactivity (Davidson ‘923, Pg. 134, Lns. 13-18; Pg. 63, Lns. 12-26).
Moreover, according to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, as clearly discussed above, Raz and Davison ‘923 teach combination compositions of THC and limonene. Raz teaches THC : limonene present in a ratio of about 2:1. Raz teaches the daily dose of the cannabinoid in the range from about 1 milligram to about 300 milligram. Davidson ‘923 teaches an embodiment of combination treatment for attenuating THC-induced psychoactivity that includes a dose of 10-40 mg limonene. Davidson ‘923 teaches combination of active agents to provide a synergistic benefit among other advantages.
Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at a composition comprising the claimed amounts and claimed ratios of THC to limonene, with a reasonable expectation of success.
In the absence of any criticality of these claimed amounts and ratios, the combined teachings of Raz and Davison ‘923 render the limitations of instant claims 6-7 and 11, prima facie obvious.
Claims 4 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Spritos (US 2021/0023044 A1, 28 January 2021).
The teachings of Spritos are set forth in the anticipation rejection above and incorporated herein by reference.
Regarding instant claims 4 and 7, Spritos anticipates the non-naturally occurring composition of instant claim 1. Spritos does not explicitly teach a ratio of THC:limonene of about 2:1 or the specific compositions of instant claim 7.
Spritos teaches embodiments wherein the pharmaceutical composition comprises about 15 mg and 30 mg of THC per dose (Para. [0051]). Spritos teaches embodiments wherein the pharmaceutical composition comprises about 1 mg and 5 mg of limonene per dose (Para. [0104]). Spritos teaches several embodiments comprising THC and a preferred terpene in various amounts. Spritos teaches that numerous variations, changes, and substitutions to the disclosed embodiments may be made by one of ordinary skill in the art (Para. [0406]).
According to MPEP 2144.05(II)(A), "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, as clearly discussed above, Spritos teaches non-naturally occurring compositions that comprise THC - that may be present in 15 mg or 30 mg per dose and limonene - that may be present in 1 mg or 5 mg per dose.
Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at a composition comprising the claimed amounts and claimed ratios of THC to limonene, with a reasonable expectation of success.
In the absence of any criticality of these claimed amounts and ratios, the teachings of Spritos render the limitations of instant claims 4 and 7, prima facie obvious.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Spritos (US 2021/0023044 A1, 28 January 2021) in view of May et al. (Dronabinol for chemotherapy-induced nausea and vomiting unresponsive to antiemetics, 2016, hereinafter May).
Regarding instant claims 2-3, Spritos anticipates the non-naturally occurring composition of instant claim 1. Spritos does not teach wherein the THC comprises synthetic THC; wherein the synthetic THC comprises dronabinol.
May teaches dronabinol to be a synthetic version of THC as an orally active cannabinoid (Abstract). May teaches dronabinol has an onset of action of approximately 0.5-1 hour, with a peak effect at 2-4 hours, lasting a total of 4-6 hours with the psychoactive effects (Pg. 51, first column, last paragraph). May teaches dronabinol has a large volume of distribution, approximately 10 L/kg, which allows for the metabolites to be released over a prolonged period of time at low levels (Pg. 51, first column, last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Spritos and May to have utilized dronabinol, a synthetic form of THC in the composition of Spritos, to arrive at the composition of the instant claims with a reasonable expectation of success. The motivation being to provide a composition with rapid onset of action with extended release potential (May, Pg. 51, first column, last paragraph).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Spritos (US 2021/0023044 A1, 28 January 2021) in view of Russo et al. (A tale of two cannabinoids: The therapeutic rationale for combining tetrahydrocannabinol and cannabidiol, 2006, hereinafter Russo, in the IDS).
Regarding instant claims 12-13, Spritos anticipates the non-naturally occurring composition of instant claim 1. Spritos does not teach a formulation for oromucosal delivery as in instant claims 12-13.
Russo teaches Sativex is a highly standardized medicinal product comprising THC that is formulated into a spray for oromucosal delivery (Pg. 239, first column, last paragraph – second column, continued paragraph). Russo teaches the oromucosal route produced reliable serum THC levels (Pg. 239, second column, second full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Spritos and Russo to have formulated a composition of THC and limonene as an oromucosal spray to arrive at the composition of the instant claims, with a reasonable expectation of success. The motivation being to provide a composition that produces reliable serum THC levels (Russo, Pg. 239, second column, second full paragraph).
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11 and 13-16 of co-pending Application No 18/041,015 in view of Spritos (US 2021/0023044 A1, 28 January 2021) and May et al. (Dronabinol for chemotherapy-induced nausea and vomiting unresponsive to antiemetics, 2016, hereinafter May).
Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to a composition comprising a combination of active agents selected to be THC and limonene.
The instant claims are drawn to a non-naturally occurring composition comprising a combination of tetrahydrocannabinol (THC) and limonene.
The claims of the reference ‘015 co-pending application are drawn to a composition comprising a combination of at least two active agents extracted from Cannabis and a pharmaceutically acceptable carrier, wherein the composition is provided in a form suitable for transmucosal administration.
Claims 2-5 of the reference ‘015 application teaches wherein the active agent is a cannabinoid, terpene, more specifically, THC and D-limonene. Claims 1, 13-16 of the reference ‘015 application teaches the composition formulated for oromucosal delivery as in instant claims 12-13. Claim 11 of the reference ‘015 application teaches a composition and a pharmaceutically acceptable carrier as in instant claim 8.
The claims of the reference ‘015 application do not explicitly teach non-naturally occurring compositions, wherein the THC is a synthetic THC, namely dronabinol, as in instant claims 2-3; wherein the composition comprises THC and limonene in said ratios or said amounts as in instant claims 4-7 and formulated as a gelcap as in instant claims 10-11.
Spritos teaches cannabinoid-based therapeutics (Abstract). Spritos teaches a pharmaceutical composition comprising tetrahydrocannabinol (THC) and limonene (Paras. [0003]-[0005]; Para. [0046]; Paras. [0103]-[0105]). Spritos teaches an exemplary embodiment wherein the formulation is prepared from THC oil isolate by mixing with the desired terpene and other excipients (evidencing a non-naturally occurring composition) (Paras. [0140]-[0143]). Spritos teaches wherein the pharmaceutical composition comprises 1-50 mg of THC per dose (Paras. [0050]-[0053]). Spritos teaches the pharmaceutical composition comprises 0.1-5 mg δ-limonene per dose (which overlaps and falls within the instantly claimed range of limonene) (Paras. [0103]-[0105]). Spritos teaches the pharmaceutical composition comprises a pharmaceutically acceptable carrier, such as, glycerin (Paras. [0013]-[0014]; Paras. [0141]; TABLE 2). Spritos teaches the pharmaceutical composition is formulated as a gel capsule (Para. [0012]; Para. [0126]).
May teaches dronabinol to be a synthetic version of THC as an orally active cannabinoid (Abstract). May teaches dronabinol has an onset of action of approximately 0.5–1 hour, with a peak effect at 2–4 hours, lasting a total of 4–6 hours with the psychoactive effects (Pg. 51, first column, last paragraph). May teaches dronabinol has a large volume of distribution, approximately 10 L/kg, which allows for the metabolites to be released over a prolonged period of time at low levels (Pg. 51, first column, last paragraph).
Therefore, the claims of the reference’015 application in view of Spritos and May, render the limitations of the instant claims prima facie obvious, using the same logic as discussed in the obviousness rejections over Spritos and May.
Therefore, instant claims 1-13 and claims 1-5, 11 and 13-16 of co-pending Application No 18/041,015 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-13 are rejected.
No claims are allowed.
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/PADMAJA S RAO/Examiner, Art Unit 1627
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