849
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 .
Priority
The instant application 17/432,849 filed on August 20, 2021 is a 371 of PCT/NL2020/050111 filed on February 21, 2020, which claims priority to, and the benefits of Foreign Application No. NL2022614 filed on February 21, 2019.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on March 13, 2026, wherein claims 1 and 10 are amended; claims 2-8, 12 and 14 are cancelled; claims 9, 11, 13 are unchanged.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 9-11 and 13 are pending and under examination.
Action Summary
Applicant’s amendment to the claims overcome each and every objection previously sets
forth in the Non-Final Office Action mailed on October 17, 2025.
Claims 1-13 rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more are maintained, but revisited and modified in light of the claim amendments.
Claims 1-13 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a pharmaceutical composition for treating cancer pain, and neuropathic pain and spasticity associated with multiple sclerosis, does not reasonably provide enablement for use in the prevention or treatment of the entire scope of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite are withdrawn in light of the claim amendments that delete the recitation of “for use in the prevention or treatment of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite” in the preamble.
Claim 12 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn, because the claim is cancelled in light of the amendments filed on March 13, 2026.
Claims 1-5 and 10-13 rejected under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 2016/0250270 A1), in view of Levy et al. (US 2017/0266153 A1) are withdrawn in light of the claim amendments.
Claims 1-5 and 9-13 rejected under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 2016/0250270 A1), in view of Levy et al. (US 2017 /0266153 A1) as applied to claims 1-5 and 10-13 above, and further in view of Levy et al. (US 2017 /0266153 A1) are withdrawn in light of the claim amendments.
Claims 1-13 rejected under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 2016/0250270 A1), in view of Levy et al. (US 2017 /0266153 A1) as applied to claims 1-5 and 9-13 above, and further in view of Hudson et al. (WO 2019/227167 A1) are withdrawn in light of the claim amendments.
Claims 1-13 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-11, 13 and 16 of copending Application No. 17/432,851 (referred to herein as ‘851 application) in view of Hudson et al. (WO 2019/227167 A1) are withdrawn in light of the claim amendments.
Claims 1-13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, and 7-9 of U.S. Patent No. 12,357,585 B2 (referred to herein as reference patent) in view of Hudson et al. (WO 2019/227167 A1) are withdrawn in light of the claim amendments.
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, 9-11 and 13 are rejected under 35 U.S.C. 101 because the claimed invention is directed to products of nature without significantly more (newly reapplied as necessitated by amendment).
Instant claim 1 recites “[a] pharmaceutical composition comprising a mixture of cannabinoids, wherein the mixture of cannabinoids is tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC) and cannabinodiol (CBND), wherein the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids; wherein the amount of CBC is less than the amount of CBG within the mixture of cannabinoids; wherein the amount of CBND is equal to the amount of CBG within the mixture of cannabinoids; wherein each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form”. Instantly claimed a mixture of THCV, CBG, CBC, and CBND in the pharmaceutical composition is not markedly different from its naturally occurring counterpart, because there is no indication that mixing/combing these naturally occurring substances has caused the instantly claimed composition to exhibits any characteristics that are markedly different from the naturally occurring counterpart. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below:
MPEP § 2106 sets forth the Subject Matter Eligibility Test to determine if a claim is directed to patent eligible subject matter. Step 1 asks if a claim is directed to a statutory category of invention. In the present case, applicant’s claims are directed to a product, in this case, a pharmaceutical composition; therefore, the answer to Step 1 is Yes.
Step 2A, Prong One, asks if a claim recites to a product of nature. In the present case, applicant’s claims recite a nature-based product, in this case, a combination of naturally occurring substances (THCV, CBG, CBC, and CBND). These individual components are found together in nature according to the chemical profile of Cannabis sativa taught by Odieka et al. (Molecules, 2022. Vol. 27(5): 1689; cited in the previous Office Action) (see e.g., Table 1). Therefore, the claims do recite a judicial exception, i.e., products of nature, which require further eligibility analysis.
MPEP § 2106.04(b) states that “[w]hen a claim recites a nature-based product limitation, examiners should use the markedly different characteristics analysis discussed in MPEP § 2106.04(c) to evaluate the nature-based product limitation and determine the answer to Step 2A”. MPEP § 2106.04(c)(I) states that “if the nature-based product limitation is not naturally occurring, for example due to some human intervention, then the markedly different characteristics analysis must be performed to determine whether the claimed product limitation is a product of nature exception…”. To perform the markedly different characteristic analysis, MPEP § 2106.04(c)(II) states “the markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties…”. In the present case, the closest counterpart to the claimed invention is the combination of extract from Cannabis plant, i.e., the individual component as they occur in nature. Since there is no indication in the specification that combining [Symbol font/0x44]9-tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), and cannabinodiol (CBND) as a whole changes the structural, functional, or other properties of these components in any marked way in comparison with the closest naturally occurring counterpart from natural plant. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2), this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claimed pharmaceutical composition does not comprise additional elements other than combining the product of natures. Thus, the answer to Step 2A, Prong Two, is No. Instant claim 11 do recites additional element “one or more drugs”. The claimed term “drug”, when given its broadest reasonable interpretation, is taken to include naturally occurring drugs. Therefore, the additional element of “one or more drugs” is not sufficient to integrate anything beyond the judicial exception, because the said element can be another components found in nature (plant). Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” Instant claim 10 recites the limitation of “wherein one or more of the cannabinoids within the mixture of cannabinoids is synthetic”. Said limitation does not introduce anything markedly different characteristics, for instance, the synthetic CBG has the same chemical structure as the CBG found in nature and that does not introduce any markedly different characteristics to the claimed pharmaceuticals composition. Instant claim(s) also recite the limitation of “each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form” and the limitation of “wherein the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids; wherein the amount of CBC is less than the amount of CBG within the mixture of cannabinoids; wherein the amount of CBND is equal to the amount of CBG within the mixture of cannabinoids” that do not constitute additional elements that amounts significantly more than the judicial exception as mixing components occurred in nature are insignificant extra-solution activities
that add nothing more than an efforts to combine the naturally occurring components. The claims recite a pharmaceutical composition at a high level of generality of simply combining each naturally occurring component together, and combining individual components in various amount and ratio is well-understood, routine, and conventional activities known to the industry. Given that each naturally occurring component retains its naturally occurring structure and properties as their natural state, instant claims do not provide any limitations beyond the judicial exception or provide anything that adds significantly more to the judicial exceptions. Thus, the answer to Step 2B is No.
Therefore, the claims are not directed to patent eligible subject matter.
Please note that the forms of gels, gel sprays, tablets and capsules in claim 9 are not rejected under 35 U.S.C. 101.
Response to Arguments
Applicant's arguments filed on March 13, 2026 with respect to the rejection of claims 1-13 under 35 U.S.C. 101 have been fully considered but they are not persuasive.
In Summary, applicant argues the claimed pharmaceutical composition possess both structural and functional characteristics that are markedly different from any naturally occurring cannabis material or extract. Applicant argues the claimed pharmaceutical composition requires isolation and purification of individual cannabinoids followed by deliberate recombination at defined ratios; and naturally occurring cannabis material contains hundreds of compounds, and none of these naturally occurring cannabis contains THCV, CBG, CBC, and CBND in the amount instantly claimed. Applicant further argues the specification demonstrates the therapeutic activity of cannabinoid combinations encompass by the present invention is critically dependent on the quantitative relationship among their components. Specifically, applicant argues when THCV, CBG, and CBC are combined in approximately balanced weight ratio (approximately 1:1:1) alongside with a higher proportion of THC (approximately 1:1:1:10 overall) provides energizing and activating effect; In contrast, the same cannabinoids when combined in a markedly skewed ratio (1:10:1:10), only 20-30% of panel membered experience the effect; and omission of one component entirely (Comparative Example 1) was identified as eliminating the psychoactive contribution necessary to achieve the desired psychological effect; and therefore, the effects are not found in the individual cannabinoid components. Applicant further argue CBND plays an active role in modulating the inter-cannabinoid effects of the pharmaceutical composition by directing attention to “[w]hen CBND is added, it functions as catalyst and enhances the effect of THC with CBG” on page 12, line 11-12 of the specification.
In response, Applicant’s argument is not found persuasive for the reasons set forth below:
Merely isolating or purifying a naturally occurring product, i.e., cannabinoids, does not make it a non-naturally occurring product if the cannabinoids remain structurally and functionally identical to its natural counterpart. Applicant fails to provide any factual evidence supporting that the isolation and purification changes the chemical structure of cannabinoids instantly claimed (THCV, CBG, CBC, and CBND). In the present case, the instant claims pertains to a pharmaceutical composition comprising a combination of four naturally occurring substances (tetrahydrocannabivarin, cannabigerol, cannabichromene and cannabinodiol) that are individually found in the chemical profile of Cannabis sativa, as evidenced by Odieka et al. It may well be true that the claimed quantitative relationship among these naturally occurring substances (tetrahydrocannabivarin, cannabigerol, cannabichromene and cannabinodiol) is not found within the naturally occurring cannabis material, e.g., Cannabis sativa; However, the claimed composition merely combines naturally occurring cannabinoids that retain their natural structural and functional characteristics. not a pharmaceutical composition instantly claimed. Solely to rebut applicant’s argument that mixing naturally occurring cannabinoids in new ratios and in specific amounts gives unexpected energizing and activating effect, first, according to Example 1 on page 14 to 15 of the specification, the cannabinoid composition upon which applicant relies was isolated from C. sativa, which is a plant found in nature, using the 11 step method describe in page 13-14 of the specification as shown below:
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. Additionally, the specification further discloses the composition and individual components were evaluated, and all panel members experienced an energizing and activating effects as shown below:
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, including those who received the individual components. While said example discloses the total amount of THCV, CBG, CBC, and THC is between 0.5 to 12 mg, it is not clear what dosage of THCV, CBG, CBC, and THC each individual received in the study. It is respectfully noted that the cannabinoid composition used in said example does not contain the cannabinodiol (CBND) instantly claimed, and also does not describe the specific amount of each THCV, CBG, CBC within the mixture (THCV + CBG + CBC + THC). Additionally, the amount of THCV does not equal to the amount of CBG (THCV is 1.4 wt % and CBG is 1.5 wt % in Example 1) in said example. According to Example 3 on page 15, 20-30% of panel members experienced an energizing and activating effect after receiving a composition consisting of THCV, CBG, CBC, and THC in a weight ratio of 1:10:1:10. In other words, the composition of Example 1 isolated from natural plant (C. sativa) and the composition of Example 3, which combine the same naturally occurring substances (THCV, CBG, CBC, and THC) in different ratios and amounts, are both capable of exerting energizing and activating effect; and therefore, by combining naturally occurring substances in different ratios and amounts, does not appear to amount significantly more than its naturally occurring counterpart. Accordingly, the alleged “energizing and activating effect” is not shown to be a new characteristic created by the claimed combination itself, but instead reflects the inherent pharmacological properties of the naturally occurring cannabinoids.
In response to applicant’s argument that “omission of one component entirely (Comparative Example 1) was identified as eliminating the psychoactive contribution necessary to achieve the desired psychological effect”, it is noted that said comparative examples 1 removes THC from the combination of THC, THCV, CBG and CBC to give a combination consisting of THCV, CBG, and CBG. Removing a naturally occurring substance from the combination of four naturally occurring substances does not make it a non-naturally occurring product if the naturally occurring substances contains in the combination remain structurally and functionally identical to its natural counterpart. In other words, by combing THCV, CBG, and CBG, it does not give markedly different characteristics from their naturally occurring counterpart, which can be the individual components as they occur in nature. Additionally, it is respectfully noted that the instant claim recites the transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. In other words, the pharmaceutical composition instantly claimed does not exclude THC as an additional unrecited elemenets. Given these reasons above, said argument is not found persuasive.
The features upon which applicant relies (i.e.,”[w]hen CBND is added, it functions as catalyst and enhances the effect of THC with CBG”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Solely to rebut applicant’s assertion that CBND enhances the effect of THC with CBG is unexpected, one would have reasonably expected that CBND in its isolated form or synthetic form will enhances the effect of THC with CBG, because Levy et al. (US 2017/0266153 A1) clearly teaches the composition comprising one or more purified cannabinoids provide a synergistic effective relative to THC alone (see e.g., abstract; [0058]; [0064]), wherein purified cannabinoid is chosen from, inter alia, THCV, CBC, CBG or CBND (see e.g., [0296]; [1894]). Therefore, CBND in the combination of four naturally occurring cannabinoids (THCV, CBG, CBC, and CBND) would have been expected to have enhancing effect.
Therefore, the rejection on the record has been revisited and modified in light of the claim amendments for the reasons set forth herein.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 9-11 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention (newly applied as necessitated by amendment).
Instant claim 1 recites “[a] pharmaceutical composition comprising a mixture of cannabinoids, wherein the mixture of cannabinoids is tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC) and cannabinodiol (CBND), wherein the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids; wherein the amount of CBC is less than the amount of CBG within the mixture of cannabinoids; wherein the amount of CBND is equal to the amount of CBG within the mixture of cannabinoids; wherein each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form”.
It is noted that the instant specification fails to disclose “CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form” and “the amount of CBC is less than the amount of CBG within the mixture of cannabinoids”.
According to MPEP 2163, I, B “[n]ew or amended claims which introduce elements or limitations that are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (an adequate description of a genus may not support claims to a subgenus or species within the genus)”. In the present case, page 12, line 9-10 of the specification discloses “In an embodiment the composition further comprises cannabinodiol (CBND), preferably in a ratio by weight CBG: CBND of 1:1”. While the specification discloses the weight ratio of CBG to CBND is 1:1, the specification fails to provide sufficient written basis to support the CBND within the mixture of tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC) and cannabinodiol (CBND) is present in an amount of 1-12 mg per unit dosage form. Additionally, page 12, line 19-21 of the specification discloses “the relative weight ratios of THCV:CBG:CBC:THC is preferably between 1-10:1-10:1-10:1-10, preferably 1-5:1-5:1-5:1-10, more preferably 1:1:1:1 to 5”. In other words, while the specification discloses the weight ratio of THCV:CBG:CBC:THC, it does not provide sufficient written basis to support the amount of CBC in the mixture of THCV, CBG, CBC and CBND is less than the amount of CBG within said mixture, and the amount of each THCV, CBG, CBC and CBND is 1-12 mg per unit dosage form.
Additionally, instant claim 10 recites “wherein one or more of the cannabinoids within the mixture of cannabinoids is synthetic”; However, the specification fails to disclose CBND is synthetic. In the present case, page 9, line 20-22 of the specification discloses “as will be apparent to the person skilled in the art, one or more of THCV, CBG, CBC and THC may be synthetic”. In other words, the specification does not provide sufficient written basis to support the CBND in the mixture of cannabinoids is synthetic.
In sum, while the specification discloses certain cannabinoid species, certain ratios, optional synthetic cannabinoids, and certain dosage information, the specification fails to provide blaze marks directing one of ordinary skill in the art to the presently claimed specific combination of
THCV, CBG, CBC, and CBND,
Wherein THCV = CBG,
CBC < CBG,
CBND = CBG, and
Each component being present at 1-12 mg per dosage form.
Accordingly, the specification does not reasonably convey possession of the presently claimed specific four-cannabinoid composition having all of the newly claimed quantitative relationships and dosage limitations together.
In view of the foregoing, the instant claim(s) contains subject matter that is not described in the specification; thus, it does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the “pharmaceutical composition” instantly claimed at the time of filing.
Accordingly, claims 9-10, 11 and 13 are rejected based on their dependency on a rejected claim that contains subject matter which was not described in the specification.
This is a new matter rejection. The amendment introduces subject matter that lacks adequate written description support in the originally filed disclosure.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1, 9-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 2016/0250270 A1; cited in the previous office action), in view of Levy et al. (US 2017/0266153 A1; cited in the previous office action) and Faraci et al. (WO 2018/152334 A1) (newly applied as necessitated by amendment).
Wendschuh et al. teaches a composition of Example 3, which is an exemplary composition comprising having one or more purified cannabinoids in combination with a purified terpene (see e.g., [0010]), shown below (see e.g., [0400]):
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.
Please note the composition of Example 3 taught by Wendschuh et al. does not comprise CBDV, CBDVA, and CBDA. Wendschuh et al. further teaches the term "cannabinoid" means any substance that acts upon a cannabinoid receptor, and examples of cannabinoids include compounds belonging to any of the following classes of molecules, their derivatives, salts, or analogs: inter alia, cannabidiol (CBD), tetrahydrocannabinol (THC), tetrahydrocannabivarin (THCV), cannabichromene (CBC), cannabigerol (CBG), cannabinodiol (CBND) (see e.g., [0018]). Wendschuh et al. further teaches the composition disclosed herein comprises a terpene chosen from, inter alia, capsaicin (see e.g., [0364]; claim 6). Wendschuh et al. further teaches cannabinoids extract, particularly tetrahydrocannabinol has many effects including pain relief (see e.g., [0005]).
Wendschuh et al. does not teach cannabinodiol (CBND). Wendschuh et al. also does not teach the amount of CBC is less than the amount of CBG within the mixture of cannabinoids; and the amount of CBND is equal to the amount of CBG within the mixture of cannabinoids. Wendschuh et al. also does not teach each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form.
Levy et al. teaches compositions purposefully formulate to provide man-made, non-naturally occurring combinations, concentrations, and/or ratios of compounds sometimes found in naturally occurring cannabis plants (see e.g., [0009]) provide particular benefits previously unavailable with naturally occurring cannabinoid profiles (see e.g., [1895]). Levy et al. further teaches the composition comprising one or more purified cannabinoids provide a synergistic effective relative to THC alone (see e.g., abstract; [0058]; [0064]), wherein purified cannabinoid is chosen from, inter alia, THC, THCV, CBC, CBG or CBND (see e.g., [0296]; [1894]). Levy et al. further teaches THC is useful for relieving pain, treating glaucoma, and relieving nausea (see e.g., [0005]). Levy et al. teaches CBND refers to cannabinodiol having the following structure formula:
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, and the compositions comprising CBND are formulated with other compounds, thereby providing previously unavailable potency, control, consistency, purity, etc (see e.g., [346]). Levy further teaches in one embodiment of the compositions, the ratio of the first purified cannabinoid to the second purified cannabinoid is between 1:1 to 1:10 (see e.g., [1678]).
Faraci et al. further teaches a composition comprising: (a) at least one cannabinoid or cannabinoid extract; and (b) at least one surfactant (see e.g., claim 1); wherein the cannabinoid is selected from one or more of the group consisting of, inter alia, tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), cannabinodiol (CBDL), or a mixture thereof (see e.g., p. 41, line 12 to p. 42, line 6; claim 33). Faraci et al. further teaches the composition contains one or more active ingredients, e.g., cannabinoid(s), in an amount selected from, inter alia, 7.5-10 mg (see e.g., p. 25, line 24-26; p. 31, line 29 to p. 32, line1). Faraci et al. further teaches the unit dose comprises about 7.5-10 mg of at least one active ingredient, e.g., cannabinoid(s) or cannabinoid extract (see e.g., p. 47, line 15-17). Faraci et al. further teaches the invention provides for a method of treating, preventing or ameliorating the symptoms of a disease, condition or pathology in an animal (e.g., human); wherein the disease condition or pathology is selected from, inter alia, pain (se e.g., p. 54, line 19-27). Faraci et al. further teaches the unit dosage may be in the form of, inter alia, tablet (see e.g., p. 46, line18-21). Faraci et al. further teaches the composition further comprising or consisting of one or more additional active ingredients, including a non-opioid analgesic/anti-inflammatory drug (see e.g., claim 189).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the present case, the difference between the composition of Example 3 of Wendschuh et al. and the claimed pharmaceutical composition is that the prior art composition does not contain the claimed cannabinodiol (CBND), and the amount of cannabichromene (CBC) is equal to the amount of cannabigerol (CBG) rather than less than the amount of cannabigerol (CBG) shown below (see shaded); and does not expressly teach each of the THCV, CBG, CBC, and CBND is in an amount of 1-12 mg per unit dosage form:
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Please note the composition of Example 3 taught by Wendschuh et al. does not comprise CBDV, CBDVA, and CBDA; reading on “wherein the pharmaceutical composition comprises no CBDV, CBDVA, and/or CBDA” in claim 13. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by selecting the composition of Example 3 of Wendschuh et al., and then modifying said composition by further incorporating cannabinodiol (CBND) of Levy et al. as the additional purified cannabinoid, then optimize the amount of CBC and the amount of CBND relative to the amount of CBG in the ratio range of 1:1 to 1:10 in order to provide benefits previously unavailable with naturally occurring cannabinoid profiles as taught by Levy et al., and then incorporate each cannabinoid in the amount of 7.5-10 mg per unit dose as taught by Faraci et al. through routine optimization. One would have been motivated to do so, because Wendschuh et al. teaches a list of exemplary cannabinoids, including cannabinodiol, that are suitable to arrive the composition; and Levy et al. teaches cannabinodiol formulated with other compounds provide previously unavailable potency, control, consistency, and purity, and further teaches combine one or more purified cannabinoids in the ratio where the first purified cannabinoid to the second purified cannabinoid ranges from 1:1 to 1:10 can formulate composition that provides benefits previously unavailable with naturally occurring cannabinoid profiles; and Faraci et al. teaches incorporating one or more cannabinoids, including tetrahydrocannabivarin, cannabigerol, cannabichromene, cannabinodiol , in the amount of about 7.5-10 mg per unit dose can be used to treat pain. One would have a reasonable expectation of success to arrive at the claimed invention through routine optimization, because one would have reasonably expected that by further incorporating cannabinodiol to the composition of Example 3 of Wendschuh et al. provides previously unavailable potency, control, consistency, and purity; and by optimizing the amount of one cannabinoid relative to the amount of another cannabinoid in the ratio between 1:1 to 1:10, including the amount of CBC is less than the amount of CBG, and the amount of CBND is equal to the amount of CBG, provides benefits unavailable with naturally occurring cannabinoid profiles, and by incorporating each cannabinoid (THCV, CBG, CBC, and cannabinodiol) in an amount of 7.5-10 mg can successfully arrive at a unit dose useful for treating pain.
With respect to “wherein the pharmaceutical composition is….tablets” in claim 9, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by further modifying the pharmaceutical composition of Wendschuh et al., Levy et al. and Faraci et al. set forth above to formulate the pharmaceutical composition in the form of tablets. One would have motivated to do so, because Faraci et al. teaches the composition comprising at least one cannabinoid or cannabinoid extract, including tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), cannabinodiol (CBDL), or a mixture thereof can be in a unit dosage form of tablets. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the pharmaceutical composition can successfully be formulate into the form of tablets suitable for administration.
With respect to the limitation of “wherein one or more of the cannabinoids THCV, CBG, CBC and THC is synthetic” in claim 10, the extracted form or naturally form or the synthetic form of the compound of claim 10 would not render the claim patentably distinct because the compound whether artificially synthesized or extracted from natural source would have the same structure and same pharmacological effect. The district court, ruling prior to the KSR decision, decided in favor of Aventis, finding that there was no teaching, suggestion or motivation to separate the isomers in a mixture to produce pure 5S ramipril. In the case law quoted by Applicant, the Federal Circuit, ruling after KSR, found that the district court had applied the teaching, suggestion or motivation doctrine too rigidly, as KSR warned against doing. Citing KSR, the Federal Circuit explained that it was only necessary to show "some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness." The court then cited a 1978 U.S. Court of Customs and Patent Appeals (CCPA) ruling for the proposition that if it is known that a desirable property of a mixture is due to one of the components of that mixture, then purifying that one component is obvious even if there is no explicit teaching to separate the mixture and purify that one component. The court also cited to CCPA decisions from 1960 and 1938 in which purified components from known mixtures were held to be obvious. As such, applying the same logic to the instant product claims, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to substitute one or more of the purified cannabinoids taught by Wendschuh et al., including THCV, CBG, CBC and THC, with its synthetic form for the same reasons set forth above. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that substituting the extracted form or naturally form of the cannabinoid with its synthetic form would have the same structure and same pharmacological effect.
With respect to the limitation of “wherein the pharmaceutical composition further comprises one or more drugs” in claim 11, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by further modifying the pharmaceutical composition of Wendschuh et al., Levy et al. and Faraci et al. set forth above to further incorporate a non-opioid analgesic/anti-inflammatory drug as the additional drug. One would have motivated to do so, because Faraci et al. teaches the composition comprising at least one cannabinoid or cannabinoid extract, including tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), cannabinodiol (CBDL), or a mixture thereof useful for treating pain, can further comprising one or more additional active ingredients, including a non-opioid analgesic/anti-inflammatory drug. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by further incorporating a non-opioid analgesic/anti-inflammatory drug as the additional active ingredient can successfully treat pain.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on March 13, 2026 with respect to the rejection of claims 1-5 and 10-13 under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 2016/0250270 A1), in view of Levy et al. (US 2017/0266153 A1); the rejection of claims 1-5 and 9-13 under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 2016/0250270 A1), in view of Levy et al. (US 2017 /0266153 A1) as applied to claims 1-5 and 10-13 above, and further in view of Levy et al. (US 2017 /0266153 A1); and the rejection of claims 1-13 under 35 U.S.C. 103 as being unpatentable over Wendschuh et al. (US 2016/0250270 A1), in view of Levy et al. (US 2017 /0266153 A1) as applied to claims 1-5 and 9-13 above, and further in view of Hudson et al. (WO 2019/227167 A1) have been fully considered but they are not persuasive.
Applicant amends claim 1 by deleting the recitation of “tetrahydrocannabinol (THC)” from the mixture of cannabinoids and deleting the recitation of “wherein mixture of cannabinoids has a relative weight ratio the relative weight ratios of THCV : CBG : CBC : THC between 1-10:1-10:1-10:1-10, and
wherein the mixture of cannabinoids has a relative weight ratio of CBG:CBND between 1:1”. Applicant further amends claim 1 by adding the new limitation of “wherein the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids; wherein the amount of CBC is less than the amount of CBG within the mixture of cannabinoids; wherein the amount of CBND is equal to the amount of CBG within the mixture of cannabinoids; wherein each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form”. Each of these findings demonstrate the amendment changes the scope of the claims; therefore, the previous rejection on the record has been withdrawn in light of the claim amendments. Upon further consideration, the new ground of rejection has been applied as necessitated by amendment.
In summary, applicant argues the amendments to the claims overcome the rejection on the record. Specifically, Applicant argues Wendschuh et al. fails to teach a pharmaceutical composition comprising the specific four cannabinoids instantly claimed, i.e., THCV, CBG, CBC, and CBND; fails to disclose cannabinodiol as a component of the cannabinoid mixture; and fails to teach the claimed amount. Applicant further argues Levy fails to identify the specific four cannabinoids instantly claimed, and fails to teach the quantitative relationship among these claimed cannabinoids; and Hudson fails to teach cannabinodiol and the specific pharmaceutical compositions defined by particular quantitative relationships among cannabinoids.
In response, applicant’s argument have been considered, but they are not found persuasive for the reasons set forth below:
First, applicant’s assertion that Wendschuh et al. fails to teach cannabinodiol appears to be mere argument without factual evidence, because Wendschuh et al. clearly teaches cannabinodiol (CBND) in the list of cannabinoids shown below (see shaded):
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(see e.g., [0018] and [0365]). Additionally, the rejection is form using the combination of prior arts rather than each prior art separately. It is respectfully noted that Levy et al. is used to teach the benefits of incorporating cannabinodiol, as well as the benefits of modify the amount of the first purified cannabinoid to the second purified cannabinoid in the ratio range of 1:1 to 1:10. Applicant’s arguments against Hudson are moot, because the new ground of rejection does not rely on said reference for any teachings or matter specifically challenge in the argument.
Therefore, the new ground of rejection has been applied as necessitated by amendment for the reasons set forth 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, 9-11 and 13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11, 6, and 9 of U.S. Patent No. 12,564,599 B2 (referred to herein as reference patent) in view of Babul et al. (WO 2008/021394 A2), Levy et al. (US 2017/0266153 A1) and Faraci et al. (WO 2018/152334 A1).
The claims of the reference patent is drawn to a composition comprising a mixture for use in the prevention and/or treatment of overweight, wherein the mixture consist essentially of tetrahydrocannabivarin (THCV), tetrahydrocannabinol (THC), cannabigerol (CBG) and cannabinodiol (CBND) in a ratio by weight of CBG:CBND of between 10:1 and 1:10 (see claim 1); wherein the composition is a gel, gel spray, a tablet, a liquid, a capsule, in a form suitable for vaporization or in a form suitable for nebulization (see claim 6); wherein at least one of the THCV, the THC, the CBG, and the CBND is synthetic (see claim 9). Please also note the composition taught by the reference patent is silent about the inclusion CBDV, CBDVA, and/or CBDA, and would be reasonable to interpret the reference’s silence of the negative limitation to exclude CBDV, CBDVA, and/or CBDA as teachings that the reference does not include CBDV, CBDVA, and/or CBDA. Please also note CBG:CBND in the ratio of 10:1 and 1:10 touches the 1:1 ratio.
The reference patent does not teach cannabichromene (CBC). The reference patent does not teach each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form. The reference patent does not teach the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids; and also, does not teach the amount of CBC is less than the amount of CBG within the mixture of cannabinoids.
Babul et al. teaches the cannabinoids agonist useful for the present invention may be selected from, inter alia, THC and cannabichromene (see e.g., [00176]); and the cannabinoid against is useful for treating or preventing medical condition that is obesity (see e.g., claims 73-74).
Levy et al. teaches compositions purposefully formulate to provide man-made, non-naturally occurring combinations, concentrations, and/or ratios of compounds sometimes found in naturally occurring cannabis plants (see e.g., [0009]) provide particular benefits previously unavailable with naturally occurring cannabinoid profiles (see e.g., [1895]). Levy et al. further teaches the composition comprising one or more purified cannabinoids provide a synergistic effective relative to THC alone (see e.g., abstract; [0058]; [0064]), wherein purified cannabinoid is chosen from, inter alia, THC, THCV, CBC, CBG or CBND (see e.g., [0296]; [1894]). Levy further teaches in one embodiment of the compositions, the ratio of the first purified cannabinoid to the second purified cannabinoid is between 1:1 to 1:10 (see e.g., [1678]).
Faraci et al. further teaches a composition comprising: (a) at least one cannabinoid or cannabinoid extract; and (b) at least one surfactant (see e.g., claim 1); wherein the cannabinoid is selected from one or more of the group consisting of, inter alia, tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), cannabinodiol (CBDL), or a mixture thereof (see e.g., p. 41, line 12 to p. 42, line 6; claim 33). Faraci et al. further teaches the composition contains one or more active ingredients, e.g., cannabinoid(s), in an amount selected from, inter alia, 7.5-10 mg (see e.g., p. 25, line 24-26; p. 31, line 29 to p. 32, line1). Faraci et al. further teaches the unit dose comprises about 7.5-10 mg of at least one active ingredient, e.g., cannabinoid(s) or cannabinoid extract (see e.g., p. 47, line 15-17). Faraci et al. further teaches the unit dosage may be in the form of, inter alia, tablet (see e.g., p. 46, line18-21).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). The difference between the composition of the reference patent and the claimed pharmaceutical composition is that the reference patent does not teach cannabichromene (CBC), each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form, the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids and the amount of CBC is less than the amount of CBG within the mixture of cannabinoids. However, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the claims of reference patent to substitute THC with cannabichromene or further incorporate cannabichromene as the cannabinoids agonist useful for treating obesity as taught by Bubal, and further optimize the amount of THCV and CBC to the amount of CBG in the ratio range of 1:1 to 1:10 as taught by Levy et al. in order to provide benefits previously unavailable with naturally occurring cannabinoid profiles, and then incorporate each cannabinoid in the amount of 7.5-10 mg per unit dose as taught by Faraci et al. through routine optimization. One would have been motivated to do so, because Bubal et al. teaches cannabichromene and THC are both cannabinoids agonist useful for the same purpose of treating obesity, and Levy et al. teaches combine one or more purified cannabinoids in the ratio where the first purified cannabinoid to the second purified cannabinoid ranges from 1:1 to 1:10 can formulate composition that provides benefits previously unavailable with naturally occurring cannabinoid profiles; and Faraci et al. teaches incorporating one or more cannabinoids in the amount of about 7.5-10 mg per unit dose is suitable for administration. One would have a reasonable expectation of success to arrive at the claimed invention through routine optimization, because one would have reasonably expected that by substituting THC with cannabichromene or further incorporating cannabichromene to the composition of the reference patent can arrive at a composition useful for the same purpose (treating obesity); and by optimizing the amount of one cannabinoid to the amount of another cannabinoid in the ratio between 1:1 to 1:10, including the amount of THCV is equal to the amount of CBG, the amount of CBC is less than the amount of CBG, provides benefits unavailable with naturally occurring cannabinoid profiles, and by incorporating each cannabinoid (THCV, CBG, CBC, and cannabinodiol) in an amount of 7.5-10 mg is useful for arriving at a unit dose suitable for administration. Please note by further incorporating cannabichromene, it renders obvious the drug recites in claim 11.
This is a nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed on March 13, 2026 with respect to the provisional rejection of claims 1-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-11, 13 and 16 of copending Application No. 17/432,851 (referred to herein as ‘851 application) in view of Hudson et al. (WO 2019/227167 A1) have been fully considered.
Applicant amends claim 1 by deleting the recitation of “tetrahydrocannabinol (THC)” from the mixture of cannabinoids and deleting the recitation of “wherein mixture of cannabinoids has a relative weight ratio the relative weight ratios of THCV : CBG : CBC : THC between 1-10:1-10:1-10:1-10, and
wherein the mixture of cannabinoids has a relative weight ratio of CBG:CBND between 1:1”. Applicant further amends claim 1 by adding the new limitation of “wherein the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids; wherein the amount of CBC is less than the amount of CBG within the mixture of cannabinoids; wherein the amount of CBND is equal to the amount of CBG within the mixture of cannabinoids; wherein each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form”. Each of these findings demonstrate the amendment changes the scope of the claims; therefore, the previous rejection on the record has been withdrawn in light of the claim amendments. Upon further consideration, the new ground of rejection has been applied as necessitated by amendment.
Applicant requests the double patenting rejections be held in abeyance until the identification of allowable subject matter. Given that Applicant did not put forth any arguments specifically against this provisional double patenting rejection, the provisional rejection has been withdrawn in light of the claim amendments for the reasons set forth above. The Examiner also noted that the copedning application is now an issued U.S. Patent No. 12,564,599 B2 published on March 3, 2026, which do not have the same claim number and language. Upon further consideration, the new ground of rejection has been applied as necessitated by amendments for the reasons set forth herein.
Claims 1, 9-11 and 13 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 7-9 of U.S. Patent No. 12,357,585 B2 (referred to herein as reference patent) in view of Levy et al. (US 2017/0266153 A1) and Faraci et al. (WO 2018/152334 A1).
The claims of the reference patent is drawn to a composition comprising a mixture of cannabinoids for use in the treatment of chronic insomnia, sleeplessness and “staying in sleep” discomfort, subjective and objective sleep disorders, primary and secondary sleep disorders, insomnia related symptoms, depression, anxiety, and/or hyperactivity, wherein the mixture of cannabinoids is cannabigerol (CBG), cannabinodiol (CBND), tetrahydrocannabinol (THC), wherein the mixture of cannabinoids has a weight ratio of CBG:CBND:THC between 10-1:1-5:1-5 or between 1-10:5-1:5-1, wherein the composition further comprises cannabinoid cannabichromene (CBC) (see claim 1); wherein the one or more cannabinoids are in the form selected from the group consisting of: gel, gel spray, tablet, liquid, capsule, for vaporization and for nebulization (see claim 7); wherein each of the CBG, CBND, THC, and CBC is synthetic (see claim 8); wherein the composition further comprising one or more synthetic sedatives or one or more sleeping pills (see claim 9). Please note the sleeping pills is a drug. Please also note the composition taught by the claims of the reference patent is silent about the inclusion CBDV, CBDVA, and/or CBDA, and would be reasonable to interpret the reference’s silence of the negative limitation to exclude CBDV, CBDVA, and/or CBDA as teachings that the reference does not include CBDV, CBDVA, and/or CBDA, absent persuasive technical reasons or evidentiary showing otherwise. Please also note CBG:CBND in the ratio of 10-1:1-5 touches the ratio of 1:1.
The claims of the reference patent does not teach tetrahydrocannabivarin (THCV), and the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids. The claims of the reference patent also does not teach the amount of CBC is less than the amount of CBG within the mixture of cannabinoids. The claims of the reference patent also does not teach each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form.
Levy et al. teaches compositions purposefully formulate to provide man-made, non-naturally occurring combinations, concentrations, and/or ratios of compounds sometimes found in naturally occurring cannabis plants (see e.g., [0009]) provide particular benefits previously unavailable with naturally occurring cannabinoid profiles (see e.g., [1895]). Levy et al. further teaches the composition comprising one or more purified cannabinoids provide a synergistic effective relative to THC alone (see e.g., abstract; [0058]; [0064]), wherein purified cannabinoid is chosen from, inter alia, THC, THCV, CBC, CBG or CBND (see e.g., [0296]; [1894]). Levy et al. further teaches THC is useful for relieving pain, treating glaucoma, and relieving nausea (see e.g., [0005]). Levy et al. teaches THCV refers to tetrahydrocannabivarin having the following structure formula:
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, and the compositions comprising THCV are formulated with other compounds, thereby providing previously unavailable potency, control, consistency, purity, etc (see e.g., [0301]). Levy further teaches in one embodiment of the compositions, the ratio of the first purified cannabinoid to the second purified cannabinoid is between 1:1 to 1:10 (see e.g., [1678]).
Faraci et al. further teaches a composition comprising: (a) at least one cannabinoid or cannabinoid extract; and (b) at least one surfactant (see e.g., claim 1); wherein the cannabinoid is selected from one or more of the group consisting of, inter alia, tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), cannabinodiol (CBDL), or a mixture thereof (see e.g., p. 41, line 12 to p. 42, line 6; claim 33). Faraci et al. further teaches the composition contains one or more active ingredients, e.g., cannabinoid(s), in an amount selected from, inter alia, 7.5-10 mg (see e.g., p. 25, line 24-26; p. 31, line 29 to p. 32, line1). Faraci et al. further teaches the unit dose comprises about 7.5-10 mg of at least one active ingredient, e.g., cannabinoid(s) or cannabinoid extract (see e.g., p. 47, line 15-17). Faraci et al. further teaches the invention provides for a method of promoting sleep, reducing stress, and/or reducing anxiety (se e.g., p. 54, line 10-18). Faraci et al. further teaches the unit dosage may be in the form of, inter alia, tablet (see e.g., p. 46, line18-21). Faraci et al. further teaches the composition further comprising or consisting of one or more additional active ingredients, including a non-opioid analgesic/anti-inflammatory drug (see e.g., claim 189).
In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the present case, the difference between the composition of the reference patent and the claimed pharmaceutical composition is that the reference patent does not expressly teach THCV, the amount of THCV is equal to the amount of CBG, the amount of CBC is less than the amount of CBG, and each of THCV, CBG, CBC, and CBND is in an amount of 1-12 mg per unit dosage form. However, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to modify the composition of the reference patent by further incorporating THCV of Levy et al., and further optimize the amount of THCV and CBC to the amount of CBG in the ratio range of 1:1 to 1:10 as taught by Levy et al. in order to provide benefits previously unavailable with naturally occurring cannabinoid profiles, and then incorporate each cannabinoid in the amount of 7.5-10 mg per unit dose as taught by Faraci et al. through routine optimization. One would have been motivated to do so, because Levy et al. teaches THCV formulated with other compounds provide previously unavailable potency, control, consistency, and purity; and combine one or more purified cannabinoids in the ratio where the first purified cannabinoid to the second purified cannabinoid ranges from 1:1 to 1:10 can formulate composition that provides benefits previously unavailable with naturally occurring cannabinoid profiles; and Faraci et al. teaches incorporating one or more cannabinoids in the amount of about 7.5-10 mg per unit dose can be used to promote sleep and/or reducing anxiety. One would have a reasonable expectation of success to arrive at the claimed invention through routine optimization, because one would have reasonably expected that by further incorporating THCV to the composition of the reference patent provides previously unavailable potency, control, consistency, and purity; and by optimizing the amount of one cannabinoid to the amount of another cannabinoid in the ratio between 1:1 to 1:10, including the amount of THCV is equal to the amount of CBG, the amount of CBC is less than the amount of CBG, provides benefits unavailable with naturally occurring cannabinoid profiles, and by incorporating each cannabinoid (THCV, CBG, CBC, and cannabinodiol) in an amount of 7.5-10 mg is useful for treating promoting sleep and/or reducing anxiety.
This is a nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed on March 13, 2026 with respect to the rejection of claims 1, 9-10, 11 and 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, and 7-9 of U.S. Patent No. 12,357,585 B2 (referred to herein as reference patent) in view of Hudson et al. (WO 2019/227167 A1) have been fully considered.
Applicant amends claim 1 by deleting the recitation of “tetrahydrocannabinol (THC)” from the mixture of cannabinoids and deleting the recitation of “wherein mixture of cannabinoids has a relative weight ratio the relative weight ratios of THCV : CBG : CBC : THC between 1-10:1-10:1-10:1-10, and wherein the mixture of cannabinoids has a relative weight ratio of CBG:CBND between 1:1”. Applicant further amends claim 1 by adding the new limitation of “wherein the amount of THCV is equal to the amount of CBG within the mixture of cannabinoids; wherein the amount of CBC is less than the amount of CBG within the mixture of cannabinoids; wherein the amount of CBND is equal to the amount of CBG within the mixture of cannabinoids; wherein each of THCV, CBG, CBC, and CBND within the mixture of cannabinoids is present in an amount of 1-12 mg per unit dosage form”. Each of these findings demonstrate the amendment changes the scope of the claims; therefore, the previous rejection on the record has been withdrawn in light of the claim amendments. Upon further consideration, the new ground of rejection has been applied as necessitated by amendment.
Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection.
In response, since Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, the rejection has been withdrawn in light of the claim amendments for the reasons set forth above. However, upon further consideration, the new ground of rejection has been applied as necessitated by amendments.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached at (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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