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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 13, 2025 has been entered.
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.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on May 13, 2025, wherein claims 1 and 3-5 are amended; claims 2 and 6-13 are unchanged; and claim 14 is cancelled.
Claims 1-13 are pending and under examination.
Response to Amendment
Claims 1-13 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention are withdrawn in light of the claim amendment.
Claim Objections
Claims 1 and 10 are objected to because of the following informalities:
Regarding claim 1,
the recitation of “cannabichromene (CBC)” and “tetrahydrocannabinol (THC)” in line 6 is missing a comma (,) in between and that appears to be a typographical error.
the recitation of “comprises-a mixture of” in line 3 includes a hyphen (-) in between the term “comprises” and “a mixture”, said hyphen should be a space as this appears to be a typographical error.
the recitation of “wherein the mixture of cannabinoids has a relative weight ratio of CBG:CBND between 1:1” should read –wherein the mixture of cannabinoids has a relative weight ratio of CBG:CBND equal to 1:1–. It is noted a ratio is a relationship between two quantities, in this case, CBG and CBND; and the term “between” should not be used before a single fixed ratio (“1:1”) because there is no boundaries or a range for the claimed ratio.
Regarding claim 10,
the term “cannabinoids” proceeding the phrase of “THCV, CBG, CBC, and THC” should be deleted, because it is already clear that the THCV, CBG, CBC, and THC are cannabinoids as properly set forth in claim 1.
Appropriate correction is required.
Claim Interpretation
Regarding the limitation of “for use in the prevention or treatment of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite” in claim 1, and the limitation of “ wherein the disorder is selected from the group consisting of narcolepsy, daytime sleepiness, Alzheimer's disease, depression, attention-deficit disorder (ADHD), myotonic dystrophy, post-anesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with cerebral palsy, age-related memory decline, idiopathic hypersomnia and methamphetamine ('Ice') abuse” in claim 2, each of these limitations is reasonably construed by the Examiner as being drawn to the intended use of the pharmaceutical composition set forth in claim 1, and these limitations do not create a structural difference to the pharmaceutical composition.
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 products of nature without significantly more.
Instant claim 1 recites “[a] pharmaceutical composition for use in the prevention or treatment of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite, wherein the pharmaceutical composition comprises a mixture of cannabinoids, wherein the mixture of cannabinoids is tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), tetrahydrocannabinol (THC), and cannabinodiol (CBND), wherein mixture of cannabinoids has a relative weight ratio 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”. Instantly claimed a mixture of THCV, CBG, CBC, THC, 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, THC, 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) (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. Since there is no indication in the specification that combining [Symbol font/0x44]9-tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC), [Symbol font/0x44]9-tetrahydrocannabinol (THC), 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 THCV, CBG, CBC and THC 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 claims recite a mixture of a mixture of THCV, CBG, CBC, THC, and CBND in the pharmaceutical composition that do not constitute additional elements that amounts significantly more than the judicial exception as mixing components 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.
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 1-13 are 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. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Attention is directed to In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and, (8) the quantity of experimentation necessary. All of the Wands factors have been considered and discussed below:
(1, 5) The breadth of the claims and the Nature of the Invention: As stated in MPEP 2164.05(a), “[t]he initial inquiry” for determining whether the Specification is enabling “is into the nature of the invention, i.e., the subject matter to which the claimed invention pertains.”
In the present case, claim 1 recites “[a] pharmaceutical composition for use in the prevention or treatment of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite, wherein the pharmaceutical composition comprises a mixture of cannabinoids, wherein the mixture of cannabinoids is tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC) tetrahydrocannabinol (THC), and cannabinodiol (CBND), wherein mixture of cannabinoids has a relative weight ratio THCV : CBG : CBC : THC between 1 - 10 : 1 - 10: 1 - 10 : 1 - 10, and wherein the mixture of cannabinoids has relative weight ratio of CBG:CBNS between 1:1”.
The recitation of “disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite”, when reasonably construed in light of page 7, line 32 to p. 8, line 5 of the specification, is taken to include narcolepsy, a disorder marked by uncontrollable attacks of daytime sleepiness, Alzheimer's disease, attention-deficit disorder (ADHD), myotonic dystrophy, multiple sclerosis-induced fatigue, post-anesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with cerebral palsy, age-related memory decline, idiopathic hypersomnia, methamphetamine ('Ice') abuse, apathy in the elderly, jet lag, cancer-associated fatigue and opioid-induced sedation, fatigue in Charcot-Marie-Tooth Disease (CMT), everyday cat-napping, chronic fatigue and languid and listless modes.
Therefore, the breadth of the claims pertain to a pharmaceutical composition with an intended use that covers the prevention and treatment of the entire scope of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite.
(2, 3, 4) The state of the prior art, the level of skill in the art, and the predictability or lack
thereof in the art: As stated in MPEP 2164.05(a), “[t]he state of the prior art is what one skilled in the
art would have known, at the time the application was filed, about the subject matter to which the
claimed invention pertains” and, as stated in MPEP 2164.05(b), “[t]he relative skill of those in the art
refers to the skill of those in the art in relation to the subject matter to which the claimed invention
pertains at the time the application was filed.”
As discussed above, the claimed invention pertains to a pharmaceutical composition 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.
At the time the application was filed, one skilled in the art would have known that nabiximols, which is a specific extract from cloned plants of Cannabis sativa consist of an approximate 1:1 fixed ratio of [Symbol font/0x44]9-THC and CBD, is approved in several countries for the treatment of cancer pain, neuropathic pain in patients affected by multiple sclerosis (MS), and MS-related moderate to severe spasticity, as evidenced by Gado et al. (Medicines, 2018. Vol. 5, 91) (see e.g., p. 5, “2.3. Nabiximols”). One would have also known that the adverse effects associated with nabiximols treatment include drowsiness, fatigue, impaired balance and disturbance in attention, as evidenced by Gado et al. (see e.g., p. 6, 2nd last paragraph). The cited reference demonstrates that cannabis may help manage certain symptoms of multiple sclerosis, including pain and spasticity; However, the state of the art with respect to treating multiple sclerosis-induced fatigue is still underdeveloped, because fatigue is taught to be an adverse effects associated with the treatment of Cannabis extract, such as nabiximols.
According to Langlois et al. (Front Psychiatry. 2021;12: 625158), the evidence from longitudinal studies suggest that there is a bidirectional relationship between cannabis use and depression, such that cannabis use increases the risk for depression and vice-versa. Clinical evidence also suggests that cannabis use is associated with a worse prognosis in individuals with major depressive disorder (see e.g., abstract). Given that there is insufficient data to determine the impact of cannabis use on cognition in individuals with major depression disorder, the cited reference demonstrate the state of the art with respect to treating the entire scope of the disease related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite, including depression, is still underdeveloped.
According to Alzeheimers.gov (“Can I Prevent Dementia?”[Online]), there are currently no approaches that have been proven to prevent Alzheimer’s disease. Each of these findings demonstrate the state of the art with respect to preventing the entire scope of disease related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite, including Alzheimer’s disease, is still underdeveloped.
While applicant’s claimed pharmaceutical composition may play a role in treating cancer pain, and neuropathic pain and spasticity associated with multiple sclerosis, it is uncertain whether any pharmaceutical composition comprising the mixture of cannabinoids (THCV, CBG, CBC, THC and CBND) in the relative weight ratio instantly claimed can be used to prevent or treat the entire scope of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite, because it is highly unpredictable that the claimed pharmaceutical composition will successfully prevent and treat the entire scope of the disorders without undue experimentation.
(6, 7, 8) The amount of guidance given, the presence of working example and the quantitation
of experimentation required:
In view of all of the foregoing, at the time the invention was made, it would have required undue experimentation to practice the entire scope of the claimed invention. In the present case, the specification only discloses 20-30% of the 67 panel members experienced an energizing and activating effect after taking a composition consisting of THCV, CBG, CBC, and THC in a weight ratio of 1:10:1:10, and a daily unit dosages of 1-12 mg (see e.g., Example 3). It is noted that 70-80% of the panel members do not experience any energizing and activating effect; and the exemplified composition does not contain a cannabinodiol (CBND). The baseline demographics and disease characteristics of these panel members have not been disclosed; thus, it is not clear whether these panel members are healthy subjects or subjects having a disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite. Therefore, one of the relative skill in the art could not reasonably predict which disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite encompassed by the claims could be prevented or treated by the claimed pharmaceutical composition based on the limited disclosure provided; therefore, it would require an undue experimentation as it is highly unpredictable that the claimed pharmaceutical composition would, in fact, be usable across the entire scope of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite with the intention to prevent or treat.
Accordingly, the intended use of the claimed pharmaceuticals composition that covers preventing or treating the entire scope of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite are not enabled by the instant specification. To overcome this rejection, Applicant should narrow the scope of the claims such that they bear a reasonable correlation with the disclosure.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, the recitation of “wherein THC is to be administered separately, simultaneously or sequentially to THCV, CBG and CBC” renders the claim indefinite, because the claim is drawn to a product (i.e., a pharmaceutical composition) but recites a method steps; therefore, it is not clear whether the claim is drawn to a product or a method of use. For instance, the structural limitations of the claimed pharmaceutical composition lacks clarity because it is not clear how the “THC” can be administered separately, simultaneously or sequentially to THCV, CBG and CBC when the pharmaceutical composition comprises a mixture of THCV, CBG, CBC, THC and CBND in a single entity.
In order to advance prosecution, the Examiner is examining the claim to the extent that the claimed limitation is drawn to an intended use of the THC in the mixture of cannabinoids contains within the pharmaceutical composition instantly claimed.
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 1-5 and 10-13 are 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).
Wendschuh et al. teaches a composition of Example 6, 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., [0403]):
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152
466
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.
Please note the relative weight ratio of THCV:CBG:CBC:THC in the composition of Example 6 of Wendschuh et al. is 2:1:1:3. Please also note the composition of Example 6 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 the term capsaicin is often used as an analgesic in topical ointments and dermal patches to relieve pain and as an anti-inflammatory (see e.g., [0055]). Please note the capsaicin taught by Wendschuh et al. is a drug.
Wendschuh et al. does not specifically teach a pharmaceutical composition comprising tetrahydrocannabinol, tetrahydrocannabivarin, cannabichromene, cannabigerol, and cannabinodiol in the relative weight ratio instantly claimed.
Levy et al. teaches a 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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191
335
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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]).
In the present case, the difference between the composition of Example 6 of Wendschuh et al. and the claimed pharmaceutical composition is that the prior art composition contains cannabidiol (CBD) rather than the claimed cannabinodiol (CBND). 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 Example 6 of Wendschuh et al. by substituting cannabidiol (CBD) with cannabinodiol (CBND) in the amount taught by the prior art. One would have been motivated to do so, because Wendschuh et al. teaches a list of exemplary cannabinoids suitable for the composition, including cannabidiol and cannabinodiol; and Levy et al. teaches the compositions comprising one or more purified cannabinoids, including THC, THCV, CBC, CBG and CBND, provide a synergistic effect when compared to THC alone, and CBND formulated with other compounds provide previously unavailable potency, control, consistency, and purity. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by replacing CBD with CBND in the composition of Example 6 of Wendschuh et al. would successfully exhibits synergistic effect when compared to THC alone, and provide previously unavailable potency, control, consistency, and purity to the composition.
With respect to the limitation of “wherein the mixture of cannabinoids has a relative weight ratio of CBG:CBND between 1:1” in claim 1, the relative weight ratio between CBG and CBND in the modified composition of Example 6 of Wendschuh et al. set forth above (substitute cannabidiol with cannabinodiol in the same amount) can be reasonably calculated by
C
B
G
:
C
B
N
D
=
1
g
:
1
g
=
1
:
1
, to give a relative ratio of 1:1; and that renders obvious the limitation instantly claimed.
With respect to “for use in the prevention or treatment of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite” in claim 1, and “wherein the disorder is selected from the group consisting of narcolepsy, daytime sleepiness, Alzheimer's disease, depression, attention-deficit disorder (ADHD), myotonic dystrophy, post- anesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with cerebral palsy, age-related memory decline, idiopathic hypersomnia and methamphetamine ('Ice') abuse” in claim 2, each of these limitations are drawn to an intended use of the pharmaceutical composition instantly claimed. The intended use of the claimed pharmaceutical composition does not patentably distinguish the pharmaceutical composition, per se, since such undisclosed use would naturally flow from the fact that the claimed invention is obvious in view of Wendschuh et al. and Levy et al. (see rejection above). In order to be limiting, the intended use must create a structural difference between the claimed pharmaceutical composition and the prior art composition.
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; therefore, in the present case, it would have been prima facie obvious to substitute one of the purified cannabinoids, such as THCV, CBG, CBC and THC, with its synthetic form for the reasons set forth herein.
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 further modify the pharmaceutical composition of Wendschuh et al. and Levy et al. to further incorporate capsaicin. One would have motivated by the fact that Wendschuh et al. teaches capsaicin is a terpene often used as an analgesic in topical ointments and dermal patches to relieve pain and as an anti-inflammatory. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by further incorporating another terpene, such as capsaicin, into the modified pharmaceutical composition of Wendschuh et al. and Levy et al. set forth above can successfully exhibits analgesic and anti-inflammatory properties.
With respect to “wherein THC is to be administered separately, simultaneously, or sequentially to THCV, CBG, and CBC” in claim 12, these limitations are method steps. Since the claim is interpreted to be a product, said method steps in the product claims do not further limit the structural components of the composition. Therefore, the claimed pharmaceutical composition is a pharmaceutical composition which is met by the cited prior arts. In re Thorpe, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir.1985).
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.
Claims 1-5 and 9-13 are 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).
The teachings of Wendschuh et al. and Levy et al. are set forth above and applied as before.
Wendschuh et al. and Levy et al. does not specifically teach the composition is in the form as claimed in claim 9.
In addition to the teachings set forth above, Levy et al. further teaches the purposefully purified components in the carrier oil is used with a device, e.g., vaporizer, intravenous drug, etc (see e.g., [0737]). Levy et al. further teaches the term “use” includes consuming via ingestion or heating and inhaling by, for example, combusting or vaporizing. (See e.g., [0739]).
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the composition of Example 6 of Wendschuh et al. and Levy et al. set forth above in the form of composition for vaporization. One would have been motivated to do so, because Levy et al. teaches the composition comprising one or more purified cannabinoids in the carrier oil can be used with a vaporizer. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by incorporating the composition of Example 16 of Wendschuh et al. and Levy et al. with a castor oil can successfully be inhale through vaporization.
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.
Claims 1-13 are 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).
The teachings of Wendschuh et al. and Levy et al. are set forth above and applied as before.
Wendschuh et al. and Levy et al. does not specifically teach the pharmaceutical composition comprises a unit dosage form comprising between 1-12 mg of each of THCV, CBG, CBC and THC as claimed in claims 6. Wendschuh et al. and Levy et al. also does not teach a maximum daily dosage of THC is less than or equal to 130 mg as claimed in claim 7. Wendschuh et al. and Levy et al. also does not teach a maximum daily dosage of each of THCV, CBG, and CBC is less than or equal to 120 mg as claimed in claim 8. However, Wendschuh et al teaches cannabinoids extract, particularly tetrahydrocannabinol has many effects including pain relief (see e.g., [0005]), and Levy et al. also teaches cannabinoids extract, particularly tetrahydrocannabinol is useful for relieving pain (see e.g., [0005]).
Hudson et al. teaches a pharmaceutical composition useful for treating or delaying the progression of mesothelioma, including diminishing of signs or symptoms of mesothelioma (see e.g., p. 21, line 27 to p.22, line 5), in an individual in need thereof comprising one or more cannabinoids selected from the group consisting of, inter alia, tetrahydrocannabinol (THC), tetrahydrocannabivarin (THCV), cannabigerol (CBG), and cannabichromene (CBC), or pharmaceutically acceptable salts thereof, and a pharmaceutically acceptable excipient (see e.g., claims 1 and 34). Hudson et al. further teaches the main symptoms of pleural mesothelioma includes, inter alia, chest pain or pain in the shoulder and upper arm (see e.g., p. 21, line 12-15). Hudson et al. teaches the pharmaceutical composition adapted for oral administration, can be presented as discrete units such as capsules or tablets (see e.g., p. 32, line 1-4). Hudson et al. further teaches the pharmaceutical compositions may be provided in the form of tablets containing one or more cannabinoids particularly, inter alia, 1.0, 5.0, and 10.0 mg of the cannabinoids for the symptomatic adjustment of the dosage to the patient to be treated (see e.g., p. 37, line 8-12). Please note the dosage in the form of tablets taught by Hudson et al. is a unit dosage form. Hudson et al. further teaches the therapeutically effective amount of the one or more cannabinoids may be administered to a subject once a day, twice a day, or three times a day to treat or minimize the progression of mesothelioma (see e.g., p. 31, line 1-3). Hudson et al. further teaches cannabis extracts have already been approved in some countries for the treatment of pain relief (see e.g., p. 19, line 19-21).
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). Even though Wendschuh et al. and Levy et al. does not specifically teach the unit dosage form (“a unit dosage form comprising between 1-12 mg of each of THCV, CBG, CBC and THC”) and the maximum daily dosage instantly claimed (“THC is less than or equal to 130 mg”, and “each of THCV, CBG, and CBC is less than or equal to 120 mg”), it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the pharmaceutical composition of Wendschuh et al. and Levy et al. set forth above into the unit dosage form taught by Hudson et al. One would have been motivated to do so, because Hudson et al. teaches the composition comprising one or more cannabinoids, including THCV, CBG, CBC and THC, can be presented as discrete units such as tablets, and the dosage in the form of tablets particularly contains 1.0 mg of one or more cannabinoids is useful for diminishing signs or symptoms of mesothelioma, including pain. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by modifying the pharmaceutical composition of Wendschuh et al. and Levy et al. to contain 1.0 mg of each of THCV, CBG, CBC, and THC , said pharmaceutical composition would successfully exhibit pain relief properties. Please note 1 mg of each of THCV, CBG, CBC and THC meets the structural limitations of the maximum daily dosage of THC (1 mg of THC is less than 130 mg), and the maximum daily dosage of each THCV, CBG, and CBC (1 mg of THCV, CBG, and CBC is less than 120 mg) instantly claimed.
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 May 13, 2025 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) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant's arguments filed on May 13, 2025 with respect to 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) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant's arguments filed on May 13, 2025 with respect to 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 for the reasons set forth below.
Applicant amends claim 1 from the recitation of “wherein the pharmaceutical composition comprises a combination of tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC) tetrahydrocannabinol (THC), and cannabinodiol (CBND)” to the recitation of “wherein the pharmaceutical composition comprises a mixture of cannabinoids, wherein the mixture of cannabinoids is tetrahydrocannabivarin (THCV), cannabigerol (CBG), cannabichromene (CBC) tetrahydrocannabinol (THC), and cannabinodiol (CBND)”, and that changes the scope of the claims; therefore, the rejection on the record has been revisited and modified in light of the claim amendments. In addition, the Examiner noted that the previous office action has mistakenly indicate the composition of Example 6 as “the composition of Example 16” in some paragraphs, thus, the typographical errors has been corrected in this office action.
In Summary, applicant argues although Wendschuh et al. teaches CBND in a laundry list of cannabinoids, said prior art does not teach or suggest substituting CBND for CBD. Applicant further argues Levy et al. also teaches a laundry list of cannabinoids, and that does not teach or suggest substituting CBND for CBD as well as incorporating these components in a ratio of 1:1. Applicant further argues even if one were to consider substituting CBND for CBD, there would be no motivation or reasonable expectation of success to do so.
In response, applicant’s argument is not found persuasive for the reasons set forth below:
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the present case, the rejection on the record is form on the basis that Wendschuh et al. teaches a composition of Example 6 shown below:
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(see e.g., [0403]) in view of the teachings of Levy et al. rather than Wendschuh et al. or Levy et al. alone. It is noted that the relative weight ratio of THCV:CBG:CBC:THC:CBD is 2:1:1:3:1. The difference between the composition of Example 6 of Wendschuh et al. and the claimed pharmaceutical composition is that the prior art composition contains cannabidiol (CBD) rather than the claimed cannabinodiol (CBND). However, Wendschuh et al. also teaches a list of exemplary cannabinoids that can be used to arrive at the composition in paragraph [0018] shown below:
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; and Wendschuh et al. also teaches:
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(see e.g., claim 9). In other words, cannabidiol (CBD) and cannabinodiol (CBND) are interchangeable because each is taught by Wendschuh et al. to be a suitable cannabinoid for the composition. One would have been motivated to substitute the cannabidiol in the composition of Example 6 of Wendschuh et al. with the cannabinodiol, because Levy et al. teaches the compositions comprising cannabinodiol (CBND) formulated with other compounds provides previously unavailable potency, control, consistency, purity, etc (see e.g., [346]); and teaches the composition provide a synergistic effect compared to THC alone (see e.g., [0058]). Therefore, one would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by modifying the composition of Example 6 of Wendschuh et al. by replacing CBD with CBND in the same amount would successfully incorporate the benefits taught by Levy et al., which is to provide previously unavailable potency, control, consistency, and purity to the composition. Since there is some teaching, suggestion, or motivation to interchange the cannabidiol and cannabinodiol based on the benefits taught by Levy et al., the rejection is maintained but revisited and modified in light of the claim amendment.
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 1-13 are 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).
The claims of ‘851 application is drawn to a composition comprising a mixture for use in the prevention and/or treatment of overweight, wherein the mixture comprises tetrahydrocannabivarin (THCV), tetrahydrocannabinol (THC), cannabigerol (CBG) and cannabinodiol (CBND) in a ratio by weight of THCV:THC of between 1:5 and 5:1 and CBG:CBND of between 10:1 and 1:10 (see claim 1); wherein the composition is a unit dosage from comprising less than or equal to 120 mg of THCV (see claim 10); wherein the composition is a unit daily dosage from comprising less than or equal to 150 mg of THC (see claim 11); 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 13); wherein at least one of the THCV, the THC, the CBG, and the CBND is synthetic (see claim 16). Please note the CBND taught by the claims of ‘851 application is a cannabinodiol. Please also note the composition taught by the claims of ‘851 application 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 claims of ‘851 application does not teach cannabichromene (CBC) and a weight ratio of THCV:CBG:CBC:THC as claimed.
Hudson et al. teaches a therapeutically effective amount of cannabichromene is useful for treating mesothelioma in an individual in need thereof (see e.g., p. 4, line 18-21). Hudson et al. further teaches the pharmaceutical compositions may be provided in the form of tablets containing one or more cannabinoids particularly, inter alia, 1.0, 5.0, and 10.0 mg of the cannabinoids for the symptomatic adjustment of the dosage to the patient to be treated (see e.g., p. 37, line 8-12). Hudson et al. further teaches the therapeutically effective amount of the one or more cannabinoids may be administered to a subject once a day, twice a day, or three times a day to treat or minimize the progression of mesothelioma (see e.g., p. 31, line 1-3). Hudson et al. further teaches the cannabinoids are synthetically produced (see e.g., p. 14, line 10).
While the claims of ‘851 application does not teach CBC and a weight ratio of THCV:CBG:CBC:THC as claimed, 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 ‘851 application to further incorporate CBC, and the dosage of one or more cannabinoids in the amount taught by Hudson et al. in order to formulate a pharmaceutical composition useful for the treatment of mesothelioma. One would have been motivated to incorporate CBC, because Hudson et al. teaches CBC in a therapeutically effective amount is useful for treating mesothelioma, and a tablet containing one or more cannabinoids particularly including, inter alia, 1.0 mg of the cannabinoids given once a day is also useful for the same purpose. One of ordinary skill in the art would have a reasonable expectation of success to arrive the claimed invention, because one would have reasonably expected that the composition taught in the claims of ‘851 application modified with CBC and the dosage of 1.0 mg of one or more cannabinoids taught by Hudson et al. would provide a tablet with a weight ratio of THCV:CBG:CBC:THC in 1:1:1:1, and expected to be useful for treating mesothelioma, absent factual evidence to the contrary. Please note 1.0 mg of one or more cannabinoids in a form of tablet suitable for once a day administration, as taught by Hudson et al., renders obvious the unit dosage form comprising 1-12 mg of each cannabinoid recites in claims 6 and the maximum daily dosage recites in claims 7-8.
With respect to “for use in the prevention or treatment of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite” in claim 1, and “wherein the disorder is selected from the group consisting of narcolepsy, daytime sleepiness, Alzheimer's disease, depression, attention-deficit disorder (ADHD), myotonic dystrophy, post- anesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with cerebral palsy, age-related memory decline, idiopathic hypersomnia and methamphetamine ('Ice') abuse” in claim 2, these limitations are drawn to an intended use of the pharmaceutical composition instantly claimed. The intended use of the claimed pharmaceutical composition does not patentably distinguish the pharmaceutical composition, per se, since the pharmaceutical composition taught by the claims of ‘851 application and Hudson et al. meets the structural limitations and is likely to intrinsically possess the same characteristics.
With respect to “wherein THC is to be administered separately, simultaneously, or sequentially to THCV, CBG, and CBC” in claim 12, these limitations appear to be method steps. Since the claim is interpreted to be a product, said method steps in the product claims do not appear to further limit the structural components of the composition. Therefore, the composition is a composition which is met by the prior art. In re Thorpe, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir.1985).
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, as taught by the claims of ‘851 application and Hudson et al., absent factual evidence to the contrary.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed on May 13, 2025 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 and 13 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 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, said provisional rejection is maintained but revisited and modified in light of the 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).
Please note this nonstatutory double patenting rejection is the same as the provisional nonstatutory double patenting rejection over copending Application No. 17/432,850 as set forth in the previous office action. Since the copending application is now an issued U.S. Patent No. 12,357,585 B2 published on July 15, 2025, and do not have the same claim numbers and language, this nonstatutory double patenting rejection are revisited and modified in light of the issued patent; However, this rejection should be interpretated as being the same as corresponding to the provisional nonstatutory double patenting rejection.
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 ratio of CBG:THC by weight is between 7:3 and 3:6 (see claim 2); wherein the maximum daily dosage of CBG is less than or equal to 120 mg (see claim 4); wherein the maximum daily dosage of cannabinoids is less than or equal to 130 mg of CBND, less than or equal to 20-80 mg of THC and less than or equal to 130 mg of CBC (see claim 5); 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 a weight ratio of THCV:CBG:CBC:THC as claimed.
Hudson et al. teaches a therapeutically effective amount of tetrahydrocannabivarin is useful for treating mesothelioma in an individual in need thereof (see e.g., p. 3, line 10-14). Hudson et al. further teaches the pharmaceutical compositions may be provided in the form of tablets containing one or more cannabinoids particularly, inter alia, 1.0, 5.0, and 10.0 mg of the cannabinoids for the symptomatic adjustment of the dosage to the patient to be treated (see e.g., p. 37, line 8-12). Hudson et al. further teaches the therapeutically effective amount of the one or more cannabinoids may be administered to a subject once a day, twice a day, or three times a day to treat or minimize the progression of mesothelioma (see e.g., p. 31, line 1-3).
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). While the composition taught by the claims of the reference patent does not include THCV and the weight ratio of THCV:CBG:CBC:THC instantly claimed, 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 taught in the claims of the reference patent to further incorporate THCV, and further incorporate the dosage of one or more cannabinoids in the amount taught by Hudson et al. in order to formulate a pharmaceutical composition useful for the treatment of mesothelioma. One would have been motivated to incorporate THCV, because Hudson et al. teaches THCV in a therapeutically effective amount is useful for treating mesothelioma, and a tablet containing one or more cannabinoids particularly including, inter alia, 1.0 mg of the cannabinoids given once a day is also useful for the same purpose. One of ordinary skill in the art would have reasonably expected that the composition taught in the claims of the reference patent modified with THCV and the dosage of 1.0 mg of one or more cannabinoids taught by Hudson et al. would provide a tablet with a weight ratio of THCV:CBG:CBC:THC in 1:1:1:1, and expected to be useful for treating mesothelioma, absent factual evidence to the contrary. Please note 1.0 mg of one or more cannabinoids in a form of tablet suitable for once a day administration, as taught by Hudson et al., renders obvious the unit dosage form comprising 1-12 mg of each cannabinoid recites in claims 6 and the maximum daily dosage recites in claims 7-8.
With respect to “for use in the prevention or treatment of disorders related to depression, fatigue, deteriorated alertness, excessive daytime sleepiness and reduced appetite” in claim 1, and “wherein the disorder is selected from the group consisting of narcolepsy, daytime sleepiness, Alzheimer's disease, depression, attention-deficit disorder (ADHD), myotonic dystrophy, post- anesthesia grogginess, cognitive impairment in schizophrenia, spasticity associated with cerebral palsy, age-related memory decline, idiopathic hypersomnia and methamphetamine ('Ice') abuse” in claim 2, these limitations are drawn to an intended use of the pharmaceutical composition instantly claimed. Although the claims of the reference patent and Hudson et al. does not teach that the pharmaceutical composition is useful for the same purpose instantly claimed, the intended use of the claimed pharmaceutical composition does not patentably distinguish the pharmaceutical composition, per se, since the pharmaceutical composition taught by the claims of the reference patent and Hudson et al. meets the structural limitations and is likely to intrinsically possess the same characteristics.
With respect to “wherein THC is to be administered separately, simultaneously, or sequentially to THCV, CBG, and CBC” in claim 12, these limitations appear to be method steps. Since the claim is interpreted to be a product, said method steps in the product claims do not appear to further limit the structural components of the composition. Therefore, the composition is a composition which is met by the prior art. In re Thorpe, 777F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir.1985).
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, as taught by the claims of the reference patent and Hudson et al., absent factual evidence to the contrary.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed on May 13, 2025 with respect to the provisional rejection of claims 1-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 9-10 and 12-14 of copending Application No. 17/432,850, in view of Hudson et al. (WO 2019/227167 A1) have been fully considered.
Applicant requests the double patenting rejections be held in abeyance until the identification of allowable subject matter.
In response, since Applicant did not put forth any arguments specifically against this obviousness-type double patenting rejection, the rejection is maintained for the same reasons of record and the reasons set forth herein; However, the Examiner noted that the copending application is now an issued U.S. Patent No. 12,357,585 B2 published on July 15, 2025, which do not have the same claim numbers and language. Therefore, the rejection is revisited and modified in light of the issued patent for the reasons set forth herein; However, the rejection should be interpretated as being the same as corresponding to the provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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