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
This application, filed on 06/17/2022, claims priority from GB1918846.5 filed on 12/19/2019 and PCT/GB2020/053282 filed on 12/18/2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 04/26/2024, 10/08/2024 and 02/24/2025, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
DETAILED ACTION
The Applicant’s amendments and arguments submitted on 11/04/2025, have been received have been considered. Claims 1, 3-6, 8-17, and 21 were amended, and claims 7 and 19-20 were canceled.
Claims 1-6, 8-18, and 21 are pending.
Withdrawn Claims Objection
Objection to claim 21 for typographical errors is withdrawn in view of Applicant’s amendment to claim 21 that corrected the error.
Withdrawn Claim Rejections - 35 USC § 102
Rejection of claims 1-5, 7-9, 18, and 21 under 35 U.S.C. 102(a)(1)/(2) as being anticipated by G. Guy et al. (US PG-PUB 2016/0166515 A1, 06/16/2016, is withdrawn in view of Applicant amendment to claim 1 submitted on 11/04/2025, that amended claim 1 with “ethanol is present at less than 1% w/v.
Withdrawn Claim Rejections - 35 USC § 103
Rejection of claim 6 under 35 U.S.C. 103 as being unpatentable over G. Guy et al. (US PG-PUB 2016/0166515 A1, 06/16/2016, is withdrawn in view of Applicant amendment to claim that amended claim 1 with “ethanol is present at less than 1% w/v.
Withdrawn Claim Rejections - Double Patenting
Provisional rejection of claims 1-6, 8-18, and 21 on the ground of nonstatutory double patenting over claims 1-4, 6-9 of copending Application No. 17/296,076 (US PG-PUB 2022/0008355 A1) in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016), is withdrawn because copending Application No. 17/296,076 is abandoned as of 07/09/2025.
Provisional rejection of claims 1-6, 8-18, and 21 on the ground of nonstatutory double patenting over claims 1-28 of copending Application No. 18/292,844 (US20250025482A1) in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016), is withdrawn because copending Application No. 17/296,076 is abandoned as of 07/09/2025.
Rejection Maintained
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 1-6, 8-18, and 21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
The instant claims are directed to “a cannabinoid containing oral solution which comprises: a cannabinoid and a lipid solvent, characterized in that wherein: the lipid solvent is sesame oil, olive oil, soybean oil, coconut oil, or medium chain triglyceride; the cannabinoid is present in a concentration of from 25 to 75 mg/ml; and ethanol is present at less than 1 % w/v. The claims do not fall within at least one of the four categories of patent eligible subject matter because the claimed invention is directed to a product of nature without significantly more. The claims recite “cannabinoid containing oral solution which comprises: a cannabinoid and a lipid solvent, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml.” The claims further recite that “wherein the lipid solvent is sesame oil, olive oil, soybean oil, coconut oil, or medium chain triglyceride.” This judicial exception is not integrated into a practical application because the claims recite cannabinoid in an oil, e.g., sesame oil, which makes the claimed composition a naturally occurring mixture, because cannabinoid is naturally extracted from a plant and sesame oil also extracted form a plant seed and mixing two products of nature would result in a naturally occurring mixture. The cannabinoid in sesame oil is a nature-based product, so it is compared to its closest naturally occurring counterpart (the cannabinoid in its natural state in the plant) to determine if it has markedly different characteristics. While different plant extraction methods may produce different concentrations of the isolated cannabinoid, the cannabinoid in an oil per se is product of nature that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed cannabinoid isolated from a plant would exhibit the same characteristics as the naturally occurring cannabinoid in its natural state (e.g., in the plant). Moreover, the simple combination of the natural products, the cannabinoid and the oils (which are all naturally occurring oils), does not add any meaningful limitation as it is merely a nominal or token extra-solution component of the claim, and is nothing more than an attempt to generally link the products of nature to a particular technological environment.
Response to Argument
Applicant argues:
The Office alleges that a composition comprising a cannabinoid and hemp oil is a "per se a product of nature."' Without agreeing that this rejection is proper, and solely in order to advance prosecution, claim 1 is presently amended to recite wherein the lipid solvent is sesame oil, olive oil, soybean oil, coconut oil, or medium chain triglyceride. Accordingly, Applicant submits that this rejection is moot, and respectfully requests that the rejection under 35 U.S.C. 101 be withdrawn.
Examiner response:
Applicant's arguments have been fully considered but they are not persuasive. The claimed invention is directed to a product of nature: “cannabinoid and a lipid solvent (edible oils), sesame oil coconut oil; corn oil; etc.”. The claimed composition is a naturally occurring mixture, because a mixture of naturally occurring components produces a naturally occurring mixture and does not impart markedly different characteristics. For example, the mixture of cannabinoid and a naturally occurring oil (sesame oil or hemp oil) would not result in a markedly different cannabinoid. Applicant does not support the utility in the disclosure by showing the markedly different characteristics (e.g., bioactivity) of the cannabinoid in sesame oil vs. the cannabinoid in its natural state (e.g., isolated directly from the plant)…The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed cannabinoid isolated for the plant exhibit same characteristics to the naturally occurring cannabinoid in their natural state (in the plant), and the oils exhibit same characteristics to the naturally occurring in nature. The simple combination of the natural products does not add any meaningful limitation as it is merely a nominal or token extra-solution component of the claim.
Rejection Maintained/Modified in view of the amendment
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8, 12, 18, and 21 remain rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by K. Kumar et al. (WO 2016/191651 A1, 12/01/2016, “Kumar” cited in the PTO-892 dated 05/22/2025).
Kumar discloses formulations for oral administration comprising from about 0.1 to about 40 % of a cannabinoid and from about 10 to about 95 % of a lipid. [0009]. Kumar discloses cannabinoid formulations with lipid. [Pg. 50, Table 24]. Kumar discloses cannabinoid oral composition LF30 comprising 31.09%w/w cannabinoid, medium chain triglyceride, capric triglyceride, and 1%w/w ethanol; and composition LF29 comprising 31.09%w/w cannabinoid, medium chain triglyceride, capric triglyceride, and 0% ethanol. Kumar discloses that all weights herein refer to % w/w or percent weight of the total formulation, [000219].
Formulation LF30 comprises 31.09% cannabinoid, capric triglyceride (medium chain triglyceride), and 1% ethanol. [Pg. 50, Table 24].
Kumar discloses that all numerical values relating to amounts, weights, and the like, is plus or minus 10 %. [pg. 30, [000217]]. Therefore, 1% ethanol meets the limitations of amended claim 1 of “…less than 1% ethanol” because the prior art concentration necessarily is understood to include a concentration of 0.9%.
Kumar discloses that the mice were tested at various intervals following doses of mg/kg of cannabidiol given by intraperitoneal injection of a volume of 0.01 mL/g. [000253]. Kumar discloses that multiple doses of cannabinoid were tested to determine cannabinoid median effective doses that inhibited seizures in 50 % of animals (ED50s), including doses of 100 mg/kg, 103.75 mg/kg, 121.52 mg/kg, etc., wherein the median toxicity dose (TD50) was determined to exceed 500 mg/kg. [000262]. Kumar discloses that the TD50 was determined to be 262.37 mg/kg. [000263].
Accordingly, with respect to the Kumar injected solution, the mouse’s injected volume is calculated as following:
0.01 mL/g * 20 g (0.02 kg = 20 g, is the mice weight as known in the art) = 0.2 mL
262.37 mg/kg * 0.02 kg = 5.25 mg
The concentration of the injected cannabinoid solution is 5.25 mg/ 0.2 mL = 26.24 mg/mL.
Similarly, the above Kumar composition comprising 31.09% (310,9 mg cannabinoid) is calculated to be 31.09 mg/mL.
Therefore, Kumar meets each and every limitation of amended claim 1, wherein, the lipid solvent is medium chain triglyceride, the amount of CBD of 31.09 mg/ml which reads on the claimed amount of 25 to 75 mg/ml, and that the composition is an oral solution. [Pg. 5, [0083]]. The medium chain triglyceride meets claims 8 and 12. Claim 18 is met because Kumar’s composition contains less than 1% ethanol.
Respecting claim 4 and 5, Kumar discloses that the cannabinoid of LF9 is cannabidiol (CBD). [Pg. 57, Table 35, Stability Data for Cannabidiol Oral Solution Formulation # LF8].
With respect to claim 21, Kumar discloses that the cannabinoid formulation is used for the treatment of Dravet Syndrome, Lennox Gastaut Syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, schizophrenia, juvenile spasms, West syndrome, refractory infantile spasms, infantile spasms, tuberous sclerosis complex, brain tumors, neuropathic pain, cannabis use disorder, post-traumatic stress disorder, anxiety, early psychosis, Alzheimer's Disease, autism. [Pg. 2, [0007], Pg. 16, [000106]].
Concerning claims 2 and 3, the claims are drawn to Cₘₐₓ and AUC of the cannabinoid oral solution. It is recognized that the prior art of Kumar discloses substantially identical components of the claimed composition. As such, it is reasonable to presume that the prior arts composition will also have a Cₘₐₓ of greater than 250 ng/ml, and AUC of greater than 1250 ng h/ml. Applicants are reminded that the office does not have the facilities and resources to determine the Cₘₐₓ and AUC of the cannabinoid oral solution. In the absence of evidence to the contrary, the burden is on applicants to show that this property is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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 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.
§ 103 Rejection over Kumar in view of Shah
Claims 1-6, 8-12, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over K. Kumar et al. (WO 2016/191651 A1, 12/01/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, (Effective filing date 06/29/2017) “Shah” cited in the PTO-892).
Kumar discloses formulations for oral administration comprising from about 0.1 to about 40 % of a cannabinoid and from about 10 to about 95 % of a lipid. [0009]. Kumar discloses cannabinoid formulations with lipid. [Pg. 50, Table 24]. Kumar discloses cannabinoid oral composition LF30 comprising 31.09% cannabinoid, medium chain triglyceride, capric triglyceride, and 1% ethanol; and composition LF1 comprising cannabinoid, sesame oil, and 0% ethanol.
formulation LF30 comprising 31.09% cannabinoid, capric triglyceride (medium chain triglyceride), and 1% ethanol. [Pg. 50, Table 24].
Kumar discloses that all numerical values relating to amounts, weights, and the like, is plus or minus 10 %. [pg. 30, [000217]]. Therefore, 1% ethanol meet the amended claim 1, less than 1% ethanol.
Kumar discloses cannabinoid oral composition LF1 comprising sesame oil. [Pg. 50, Table 24], cannabinoid oral composition LF6 comprising cannabinoid and soybean oil. [Pg. 50, Table 24], and cannabinoid oral composition LF8 comprising olive oil. [Pg. 50, Table 24].
Kumar discloses that cannabinoid is use for the treatment of Dravet Syndrome, Lennox Gastaut Syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, juvenile spasms, West syndrome, refractory infantile spasms, infantile spasms, tuberous sclerosis complex, brain tumors, neuropathic pain, cannabis use disorder, post-traumatic stress disorder, anxiety, early psychosis, Alzheimer's Disease, autism. [Pg. 2, [0007], Pg. 16, [000106]].
However, Kumar does not disclose that the concentration of cannabinoid is 25-75 mg/mL.
Shah teaches an oral cannabinoid solution comprising cannabinoid and a lipid solvent. [Abstract], wherein cannabinoid present in an amount of from 5 to 40% (w/v), ethanol present in an amount of less than 2% (w/v), and lipid solvent present q.s. to 100%. [0022], wherein the lipid solvent is preferably sesame oil, [0023], wherein cannabinoid is selected from: CBC, CBCV, CBD, CBDA, CBDV, (CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV and THCVA, more preferably the cannabinoid is CBD. [0021].
Shah teaches that the cannabinoid containing oral solution is for use in the treatment of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, myoclonic seizures, juvenile myoclonic epilepsy, refractory epilepsy, schizophrenia, juvenile spasms, and West syndrome. [0031]. Shah teaches a formulation with 25mg/mL and 0.01% ethanol, and found that the concentration of 25 mg/mL produces a clear solution without signs of precipitation. [0046], [0047].
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to utilize Shah cannabinoid concentration in Kumar oral solution. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Shah teaches an oral cannabinoid solution comprising cannabinoid, lipid solvent, with less than 1% ethanol, for treating epilepsy and syndromes associated therewith, which is substantially identical to Kumar’s oral solution, and Shah teaches that a concentration of 25 mg/L produces stable solution. Therefore, skilled artisan would be motivated to treat epilepsy and syndromes associated therewith with 25mg/mL cannabinoid in lipid solvent and low amount of ethanol to arrive at instant claims 1, 9, 18, and 21.
The medium chain triglyceride meets claims 8 and 12.
With regard to claim 4 and 5, Kumar discloses that the cannabinoid of LF9 is cannabidiol (CBD). [Pg. 57, Table 35, Stability Data for Cannabidiol Oral Solution Formulation # LF8], and Shah teaches that preferably cannabinoid is CBD. [0023].
The combination of Kumar and Shah meet claims 10-11 because Kumar discloses formulation LF6 comprising cannabinoid, and soybean, and LF8 comprises cannabinoid and olive oil [Table 24], [Pg. 50, Table 24].
With regard to claims 2 and 3, the claims are drawn to Cₘₐₓ and AUC of the cannabinoid oral solution. It is recognized that the prior art of Kumar and Shah disclose substantially identical components of the claimed composition. As such, it is reasonable to presume that the prior arts composition will also have a Cₘₐₓ of greater than 250 ng/ml, and AUC of greater than 1250 ng h/ml. Applicants are reminded that the office does not have the facilities and resources to determine the Cₘₐₓ and AUC of the cannabinoid oral solution. In the absence of evidence to the contrary, the burden is on applicants to show that this property is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
With regard to Claim 6, Shah teaches an oral cannabinoid solution comprising cannabinoid and a lipid solvent, wherein cannabinoid present in an amount of from 5 to 40% (w/v), [0022]. Shah teaches a formulation with 25mg/mL and 100 mg/mL, and found that the concentration of 25 mg/mL produces a clear solution without signs of precipitation. [0046], [0047]. MPEP 2144.05.II.A explains: “Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” 50mg/mL falls in between two stable concentration which would motivate skilled artisan to modify the 25 mg/mL or 100 mg/mL to arrive at the claimed 50 mg/mL.
§ 103 Rejection over Kumar in view of Amada
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over K. Kumar et al. (WO 2016/191651 A1, 12/01/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892), as applied above to claims 1-5, 8-13, 18, and 21 further, in view of Amada et al. (2013). PeerJ 1:e214; ”Amada” cited in the PTO-892 dated 05/22/2025).
As discussed above, the combination of Kumar and Shah teaches a cannabinoid containing oral solution comprising 25 mg/mL cannabinoid, a lipid solvent, e.g., medium chain triglyceride, and less than 1% ethanol.
However, combination of Kumar and Shah does not disclose that the cannabinoid is CBDV.
Amada teaches the effect of CBDV on epilepsy. [Title]. Amada teaches that CBDV exerts significant anticonvulsant effects via oral and other routes of administration. [Pg. 13, 2nd para.]. Amada teaches that CBDV significantly decreased PTZ-induced seizure severity and increased latency to the first sign of seizure. When CBDV treated animals were grouped into CBDV responders and non-responders, seizure expression was suppressed in CBDV responders. These results provide the first molecular confirmation of behaviorally observed effects of the non-psychoactive, anticonvulsant cannabinoid, CBDV, upon chemically-induced seizures and serve to underscore its suitability for clinical development. [Abstract].
In view of the disclosures of Kumar, Shah and Amada, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to substitute the CBD with CBDV. It is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). One of ordinary skill in the art would have been motivated to substitute CBD with CBDV with a reasonable expectation of success because combination of Kumar and Shah teaches a cannabinoid oral composition comprising CBD and a lipid solvent, sesame oil and cannabinoid e.g., CBD or CBDV, and Amada teaches the significant effect of CBDV on epilepsy, and that CBDV significantly decreased PTZ-induced seizure severity and increased latency to the first sign of seizure. Therefore, one of ordinary skill in the art has access to the effectiveness of CBDV taught by Amada would have been motivated to prepare Kumar and Shah cannabinoid and lipid composition (e.g., cannabinoid/sesame oil composition) by substituting CBD with CBDV to arrive at instantly claimed composition of claim 13.
§ 103 Rejection over Kumar in view of Citti
Claims 14-17 are rejected under 35 U.S.C. 103 as being unpatentable over K. Kumar et al. (WO 2016191651 A1, 12/01/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892), as applied above to claims 1-5, 8-13, 18, and 21 further, in view of C. Citti, et al Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
As discussed above, the combination of Kumar and Shah discloses a cannabinoid containing oral solution comprising 25 mg/mL cannabinoid, a lipid solvent, and less than 1% ethanol, wherein cannabinoid is CBD, and the lipid solvent is, sesame oil, soybean oil, olive oil, or medium chain triglyceride.
Kumar discloses that cannabinoid formulation with lipid solvent provide good stability to the cannabinoid. [Pg. 62, [000236], [000237]].
However, while the combination of Kumar and Shah discloses that the cannabinoid of the above sesame oil, soybean oil, olive oil, or medium chain triglyceride, is CBD, Kumar does not disclose that the cannabinoid is CBD-C4.
Citti discloses that cannabidibutol (CBD-C4) is a novel cannabidiol analog with a butyl chain instead of the pentyl chain of CBD [Abstract]:
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Citti discloses the methods of isolation of natural CBDB (CBD-C4) as well as the synthesis of CBDB. [Pg. 3, ending of col. 1 to col. 2, 2nd para.]. Citti discloses that the methods include characterization of CBDB, quality control testing, and detailed validation of the methods. [Pg. 2-3]. Citti discloses the stability of CBDB in room temperature and refrigeration temperature. Citti discloses that CBDB is stable at the two different temperatures (i.e., room temperature and refrigeration temperature). [Pg. 12, col. 2, 1st para.].
In view of the disclosures of Citti, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to substitute Kumar’s and Shah’s CBD with CBDB. It is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). One of ordinary skill in the art would have been motivated to substitute CBD with CBDB with a reasonable expectation of success because Citti discloses that CBDB is a novel analog of CBD with good stability and feasible quality control analysis, and provide detailed procedure on synthesizing CBDB or isolating CBDB from natural hemp. Therefore, the one of ordinary skill in the art has access to Citti’s procedure and novel CBDB properties and stability would have been motivated to prepare Kumar’s and Shah’s cannabinoid and lipid composition (e.g., cannabinoid/sesame oil, cannabinoid/soybean oil composition, cannabinoid/olive oil composition, and cannabinoid/medium chain triglyceride composition) by substituting CBD with CBDB to arrive at instantly claimed composition of claims 14-17.
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.
Double Patenting over USPN 11,207,292 B2
Claims 1-6, 8-18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of USPN 11,207,292 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 1% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
USPN 11,207,292 B2 recites a cannabidiol (CBD) preparation comprising greater than or equal to 95% (w/w) CBD based on total amount of cannabinoid in the preparation and the remainder comprises other cannabinoids including CBDV and CBD-C4, and a method of treating epilepsy in a subject in need thereof, comprising administering a therapeutically effective amount of the CBD preparation of claim 1, wherein the epilepsy is Dravet syndrome, Lennox Gastaut syndrome, Doose syndrome, or tuberous sclerosis complex (TSC), wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD ranging from about 5 mg/kg/day to about 50 mg/kg/day, wherein the therapeutically effective amount of the CBD preparation provides a dose of CBD of 10 mg/kg/day CBD or 20 mg/kg/day.
While USPN 11,207,292 B2 recites a cannabinoid, CBD and CBD-C4 for the treatment of epilepsy is Lennox-Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, etc., however, USPN 11207292 B2 does not recite formulating the cannabinoid in a composition. USPN 11,207,292 B2 does not specifically recite that the cannabinoid concentration is 25-75 mg/ml.
However, one of ordinary skill in the art would have been motivated to formulate the cannabinoid in a composition comprising lipid solvent and less than 1% ethanol in view of Kumar and Shah.
Kumar and Shah teach as discussed above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to prepare USPN 11,207,292 B2, using 25-75 mg/ml of CBD or CBDC4 in a lipid solvent such as sesame oil, olive oil, soybean oil, or medium chain triglyceride oil in view of the teaching of Kumar and Shah. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Shah and Kumar teach an oral cannabinoid solution comprising cannabinoid, lipid solvent, with less than 1% ethanol, for treating epilepsy and syndromes associated therewith, which is substantially identical to USPN 11,207,292 B2 oral solution, and Shah teaches that a concentration of 25 mg/L produces stable solution. Therefore, skilled artisan would be motivated to treat epilepsy and syndromes associated therewith with 25mg/mL cannabinoid in lipid solvent and low amount of ethanol to arrive at instant claims 1-5, 8-18, and 21. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
With regard to Claim 6, Shah teaches an oral cannabinoid solution comprising cannabinoid and a lipid solvent, wherein cannabinoid present in an amount of from 5 to 40% (w/v), [0022]. Shah teaches a formulation with 25mg/mL and 100 mg/mL, and found that the concentration of 25 mg/mL produces a clear solution without signs of precipitation. [0046], [0047]. MPEP 2144.05.II.A explains: “Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” 50mg/mL falls in between two stable concentration which would motivate skilled artisan to modify the 25 mg/mL or 100 mg/mL to arrive at the claimed 50 mg/mL.
Double Patenting over USPN 10,849,860 B2
Claims 1-6, 8-13, 18 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of USPN 10,849,860 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 1% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
USPN 10,849,860 B2 recites in the conflicting claims “a method of treating drop seizures in a patient with Lennox-Gastaut syndrome or Dravet syndrome, comprising administering to the patient cannabidiol (CBD), wherein the CBD has a purity of at least 95% (w/w), and the CBD is administered at a dose of 5 mg/kg/day, and then the dose is increased by 2 to 5 mg/kg increments, up to 25 mg/kg/day.”
While USPN 10,849,860 B2 recites a cannabinoid for the treatment of seizures, however, USPN 10849860 B2 does not recite formulating the cannabinoid in a composition. USPN 10849860 B2 does not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., 50 mg/ml.
However, one of ordinary skill in the art would have been motivated to formulate the cannabinoid in a composition comprising 25-75 mg/ml cannabinoid, a lipid solvent and less than 1% ethanol in view of Kumar and Shah.
Kumar and Shah teach as discussed above.
The obviousness rationale is similar to the rationale in the non-statutory Double Patenting Rejection above over claims 1-26 of USPN 11,207,292 B2 in view of Kumar and Shah, page 16. Claim 6 is obvious for the same rationale in the non-statutory Double Patenting Rejection over USPN 11,207,292 B2 in view of Kumar and Shah discussed on page 17 above. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of USPN 10,849,860 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892) as applied above to claims 1-6, 8-13, 18, and 21, further in view of C. kumi, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, doi.org/10.1016/j.jpba.2019.06.049. “Citti” cited in the PTO-892 dated 05/22/2025).
The combination of USPN 10,849,860 B2, Kumar, and Shah teaches a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil, olive oil, or medium chain triglyceride, wherein the cannabinoid is present in a concentration of from 25 mg/ml. The combination of the cited claims of USPN 10,849,860 B2, Kumar and Shah do not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above. These teachings are incorporated herein by reference.
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to substitute USPN 10849860 B2, Kumar and Shah CBD with CBDB. It is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007). One of ordinary skill in the art would have been motivated to substitute CBD with CBDB with reasonable expectation of success because Citti discloses that CBDB is a novel analog of CBD with good stability and feasible quality control analysis, and provide detailed procedure on synthesizing CBDB or isolating CBDB from natural hemp. One of ordinary skill in the art has access to Citti’s procedure and novel CBDB properties and stability would have been motivated to prepare USPN 10,849,860 B2, Kumar, and Shah cannabinoid and lipid composition (e.g., cannabinoid/sesame oil composition, cannabinoid/soybean oil composition, cannabinoid/olive oil composition, and cannabinoid/medium chain triglyceride composition) by substituting CBD with CBDB and therefore, arrive art instantly claimed composition of claims 14-17.
Double Patenting over USPN 10,583,096 B2
Claims 1-6, 8-13, 18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of USPN 10,583,096 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 1% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
USPN 10,583,096 B2 recites in the conflicting claims “a method of treating Sturge Weber syndrome in a subject, comprising administering to the subject a therapeutically effective amount of cannabidiol (CBD), wherein the CBD is a highly purified extract of cannabis which comprises at least 98% (w/w) CBD, and wherein the CBD is administered in combination with one or more concomitant anti-epileptic drugs (AEDs), wherein the treating comprises treating seizures in a subject having Sturge Weber syndrome, wherein the dose of CBD ranges from about 5 mg/kg/day to about 25 mg/kg/day.”
While USPN 10,583,096 B2 recites a cannabinoid for the treatment of seizures, however, USPN 10,583,096 B2does not recite formulating the cannabinoid in a composition. The cited claims of USPN 10,583,096 B2 do not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., 50 mg/ml.
However, one of ordinary skill in the art would have been motivated to formulate the cannabinoid in a composition comprising lipid solvent in view of Kumar and Shah.
Kumar and Shah teach as discussed above.
The obviousness rationale is similar to the rationale in the non-statutory Double Patenting Rejection above over claims 1-26 of USPN 11,207,292 B2 in view of Kumar and Shah, page 16. Claim 6 is obvious for the same rationale in the non-statutory Double Patenting Rejection over USPN 11,207,292 B2 in view of Kumar and Shah discussed on page 17 above. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of USPN 10,583,096 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) as applied above to claims 1-6, 8-13, 18, and 21, further in view of C. Citti, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
The combination of USPN 10,583,096 B2, Kumar and Shah teach a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil, olive oil, or medium chain triglyceride, wherein the cannabinoid is present in a concentration of from 25 mg/mL. The USPN 10,583,096 B2, Kumar and Shah do not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above, which are incorporated herein by reference.
The obviousness rationale over Citti is similar to the obviousness rationale of claims 14-17 over claims 1-32 of USPN 10,849,860 B2 in view of Kumar and Shah, further in view of C. Citti, above, page 19.
Double Patenting over USPN 11,291,631 B2
Claims 1-6, 8-9, 13, 18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of USPN 11,291,631 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 1% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
USPN 11,291,631 B2 recites in the conflicting claims “a pharmaceutical formulation for oral administration comprising cannabidiol (CBD); a lipid solvent; an ultrahigh potency sweetener; and ethanol, wherein ethanol has a concentration of less than about 3% v/v, wherein the CBD is present in an amount of from 5 to 40% (w/v), ethanol is present in an amount of less than 2% (v/v), wherein the lipid solvent is sesame oil.”
The cited claims of USPN 11,291,631 B2 do not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., 50 mg/ml.
However, in view of USPN 11,291,631 B2, the concentration of cannabinoid of 25-75 mg/ml i.e., 50 mg/ml is obvious because MPEP explains that [In] the case where the claimed ranges "overlap" 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 instant case, the concentration 25-75 mg/ml i.e., 50 mg/ml overlapped with the concentration taught in USPN 11,291,631 B2. moreover, MPEP 2144.05.II.A explains: “Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).” Claim 2 and 3 are obvious for the same rationale discussed on page 10 above. Therefore, claim 1-6, 8-9, 12-13, 18, and 21 are obvious over USPN 11,291,631 B2.
With regard to claim 21, USPN 11,291,631 B2 specification recites a method of using the above cannabinoid solution in treating epilepsy and syndromes associated therewith [col. 3, ln. 10]. MPEP 804 states: The specification can be used as a dictionary to learn the meaning of a term in the claim. Toro Co. v. White Consol. Indus., Inc., 199 F.3d 1295, 1299, 53 USPQ2d 1065, 1067 (Fed. Cir. 1999) ("[W]ords in patent claims are given their ordinary meaning in the usage of the field of the invention, unless the text of the patent makes clear that a word was used with a special meaning."); Renishaw PLC v. Marposs Societa' per Azioni, 158 F.3d 1243, 1250, 48 USPQ2d 1117, 1122 (Fed. Cir. 1998) ("Where there are several common meanings for a claim term, the patent disclosure serves to point away from the improper meanings and toward the proper meanings."). "The Patent and Trademark Office (‘PTO’) determines the scope of the claims in patent applications not solely on the basis of the claim language, but upon giving claims their broadest reasonable construction ‘in light of the specification as it would be interpreted by one of ordinary skill in the art.’ " Phillips v. AWH Corp., 415 F.3d 1303, 1316, 75 USPQ2d 1321, 1329 (Fed. Cir. 2005) (en banc) (quoting In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364, 70 USPQ2d 1827, 1830 (Fed. Cir. 2004); see also MPEP § 2111.01. Further, those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application (as distinguished from an obvious variation of the subject matter disclosed in the reference patent or application). In re Vogel, 422 F.2d 438, 441-42, 164 USPQ 619, 622 (CCPA 1970). The court in Vogel recognized "that it is most difficult, if not meaningless, to try to say what is or is not an obvious variation of a claim," but that one can judge whether or not the invention claimed in an application is an obvious variation of an embodiment disclosed in the patent or application which provides support for the claim. According to the court, one must first "determine how much of the patent disclosure pertains to the invention claimed in the patent" because only "[t]his portion of the specification supports the patent claims and may be considered." The court pointed out that "this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined." In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010); Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003).
Claims 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of USPN 11,291,631 B2 as applied above to claims 1-6, 8-9, 13, 18 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025).
USPN 11,291,631 B2 recites a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, wherein the cannabinoid is present in a concentration of from 25 mg/mL. The USPN 11,291,631 B2 does not disclose that the lipids are soybean oil, olive oil, or medium chain triglyceride.
Kumar teaches as discussed above.
In view of Kumar, it would have been prima facie obvious to use soybean oil, olive oil, or medium chain triglyceride as the lipid solvent in USPN 11,291,631 B2 cannabinoid solution and substitute sesame oil with the soybean oil, olive oil, or medium chain triglyceride. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Kumar teaches an oral cannabinoid solution comprising cannabinoid, lipid solvent, with less than 1% ethanol, for treating epilepsy and syndromes associated therewith, which is substantially identical to USPN 11,291,631 B2 oral solution, and use soybean oil, olive oil, or medium chain triglyceride as the lipid solvent, with these oils show good stability. Moreover, it is prima facie obvious to substitute one known element for another to obtain predictable results. KSR Int'I Co. v. Teleflex, Inc., 550 U.S. 398 (2007).
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of USPN 11,291,631 B2 as applied above to claims 1-6, 8-9, 13, 18 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025), further, in view of C. Citti, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
USPN 11,291,631 B2 and Kumar teaches a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil or olive oil, wherein the cannabinoid is present in a concentration of from 25 mg/mL to 75 mg/ml. The combination of USPN 11,291,631 B2 and Kumar does not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above, and these teachings are incorporated herein by reference.
The obviousness rationale over Citti is similar to the obviousness rationale of claims 14-17 over USPN 10,849,860 B2 in view of K. Kumar, further in view of C. Citti, above, page 19.
Double Patenting over USPN 11,160,795 B2
Claims 1-6, 8-13, 18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 14-19 of USPN 11,160,795 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 10% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
The cited claims of USPN 11,160,795 B2 recite “a method of treating seizures in a human suffering from tuberous sclerosis complex comprising: (a) co-administering therapeutically effective amounts of everolimus and cannabidiol to the human suffering from a tuberous sclerosis complex; (b) monitoring the blood plasma concentrations of everolimus in the human suffering from the tuberous sclerosis complex; (c) if the human suffering from the tuberous sclerosis complex's blood plasma trough concentrations of everolimus exceed 15 ng/mL, if the Cmax exceeds 50 ng/mL, or if the AUC 0-24 exceeds 500 h*ng/mL; then (d) reducing the everolimus administered in step (a) to the human suffering from the tuberous sclerosis complex by at least 10%; wherein said monitoring in step (b) occurs one week to two weeks after the human suffering from the tuberous sclerosis complex begins receiving everolimus, and wherein the cannabidiol is synthetic or purified, wherein the amount of cannabidiol is administered in step (a) in an amount ranging from about 5 mg/kg/day to about 25 mg/kg/day, wherein the cannabidiol is synthetic, wherein the cannabidiol is purified, wherein the cannabidiol has a purity of at least 95% (w/w), wherein the cannabidiol has a purity of at least 98% (w/w).The method of claim 1, wherein the seizures are generalized seizures.
While the cited claims of USPN 11,160,795 B2 recite a cannabinoid for the treatment of seizures, however, the cited claims of USPN 11,160,795 B2 do not recite formulating the cannabinoid in a composition. The cited claims of USPN 11,160,795 B2 do not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., 50 mg/ml.
However, one of ordinary skill in the art would have been motivated to formulate the cannabinoid in a composition comprising lipid solvent in view of Kumar and Shah.
Kumar and Shah teach as discussed above, which are incorporated herein by reference.
The obviousness rationale is similar to the rationale in the non-statutory Double Patenting Rejection above over USPN 11,207,292 B2 in view of K. Kumar and Shah, page 16. Claim 6 is obvious for the same rationale in the non-statutory Double Patenting Rejection over USPN 11,207,292 B2 in view of Kumar and Shah discussed on page 17 above. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
Claims 14-17 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 14-19 of USPN 11,160,795 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892) as applied above to claims 1-6, 8-13, 18 and 21, further in view of C. Citti, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
The combination of the cited claims of USPN 11,160,795 B2 Kumar and Shah teaches a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil, olive oil, or medium chain triglyceride, wherein the cannabinoid is present in a concentration of from 25 mg/mL. The combination of the cited claims of USPN 11,160,795 B2 and Kumar does not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above and these teachings are incorporated herein by reference.
The obviousness rationale over Citti is similar to the obviousness rationale of claims 14-17 over USPN 10,849,860 B2 in view of Kumar and Shah, further in view of C. Citti, above, page 19.
Double Patenting over USPN 10,918,608 B2
Claims 1-6, 8-13, 18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 12-25 of USPN 10,918,608 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 10% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
The cited claims of USPN 10,918,608 B2 recite “a method of treating seizures in a patient suffering from Tuberous Sclerosis Complex (TSC) comprising administering cannabidiol (CBD) to the patient, wherein the CBD has a purity of at least 98% (w/w) CBD and comprises no more than 0.15% (w/w) Δ9-tetrahydrocannabidiol, and wherein the CBD is administered at a dose of 5 mg/kg/day, and then the dose is increased by 2 to 5 mg/kg, up to 25 mg/kg/day, wherein the TSC is characterized by generalized seizures or focal seizures with impairment.”
While USPN 10,918,608 B2 recites a cannabinoid for the treatment of seizures, however, USPN 10918608 B2 does not recite formulating the cannabinoid in a composition. USPN 10918608 B2 does not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., 50 mg/ml.
However, one of ordinary skill in the art would have been motivated to formulate the cannabinoid in a composition comprising lipid solvent in view of Kumar and Shah.
Kumar teaches as discussed above and incorporated herein by reference.
The obviousness rationale is similar to the rationale in the non-statutory Double Patenting Rejection above over USPN 11,207,292 B2 in view of K. Kumar and Shah, page 16. Claim 6 is obvious for the same rationale in the non-statutory Double Patenting Rejection over USPN 11,207,292 B2 in view of Kumar and Shah discussed on page 17 above. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6, 8, 12-25 of USPN 10,918,608 B2in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892) as applied above to claims 1-6, 8-13, 18, and 21, further in view of C. Citti, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
The combination of cited claims of USPN 10,918,608 B2, Kumar and Shah teach a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil, olive oil, or medium chain triglyceride, wherein the cannabinoid is present in a concentration of from 25 mg/mL to 75 mg/ml. The USPN 10918608 B2, Kumar and Shah do not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above and incorporated herein by reference.
The obviousness rationale over Citti is similar to the obviousness rationale of claims 14-17 over USPN 10,849,860 B2 in view of Kumar and Shah, further in view of C. Citti, above, page 19.
Double Patenting over USPN 10,765,643 B2
Claims 1-6, 8-9, 13, 18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of USPN 10,765,643 B2 in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 10% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
The cited claims of USPN 10,765,643 B2 recite “a method of treating seizures in a subject having Aicardi Syndrome, comprising administering to the subject in need thereof cannabidiol (CBD), wherein the CBD is present in a composition at a concentration ranging from about 25 mg/ml to about 100 mg/ml, ethanol is present in the composition at a concentration of about 79 mg/ml, sucralose at a concentration of about 0.5 mg/ml, strawberry flavoring is present in the composition at a concentration of about 0.2 mg/ml and sesame is present in the composition at an amount up to about 1.0 ml.”
The cited claims of USPN 10,765,643 B2 do not specifically recite that the ethanol concentration is less than 1%.
Shah teaches as discussed above, and incorporated herein by reference.
In view of Shah, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of instantly claimed invention to decrease the amount of ethanol of USPN 10,765,643 B2 to less than 1%. One of ordinary skill in the art would have been motivated to do so with reasonable expectation of success because Shah teaches that the recommended amount of ethanol in formulation containing alcohol should not be more than 0.01mg/ml, [0022], and Shah teaches oral solution of cannabinoid and lipid containing less than 0.2% ethanol for treating epilepsy and syndromes associated therewith, [0031], which would motivated skilled artisan looking to treat elliptic syndromes to decrease the amount of ethanol to less than 1%.
Claims 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of USPN 10,765,643 B2 in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892) as applied above to claims 1-6, 8-9, 13, 18, and 21, further, in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025).
The combination of the cited claims of USPN 10,765,643 B2 and Shah teaches a cannabinoid containing oral solution comprising a cannabinoid, a lipid solvent sesame oil, and ethanol, wherein the cannabinoid is present in a concentration of from 25 mg/mL to 100 mg/ml, and ethanol is less than 1%. The USPN 10765643 B2 and Kumar does not disclose that the lipid is olive oil, soybean oil or medium chain triglyceride.
Kumar teaches as discussed above and incorporated herein by reference.
The obviousness rationale is similar to the obviousness rationale of USPN 11,291,631 B2 over Kumar above, page 24.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of USPN 10,765,643 B2 in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892 dated 05/22/2025), and K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025), further, in view of C. Citti, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
USPN 10,765,643 B2, Shah and Kumar teach a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil or olive oil, wherein the cannabinoid is present in a concentration of from 25 mg/mL to 75 mg/ml. The combination of USPN 10,765,643 B2 and Kumar does not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above, and these teachings are incorporated herein by reference.
The obviousness rationale over Citti is similar to the obviousness rationale of claims 14-17 over USPN 10,849,860 B2 in view of K. Kumar, further in view of C. Citti, above, page 19.
Double Patenting over USPN 10709671 B2
Claims 1-6, 8-9, 13, 18, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-18, 2-22, 24 of USPN 10,709,671 B2 in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 10% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
USPN 10,709,671 B2 recites in the conflicting claims “a method of treating focal seizures in Dravet Syndrome, comprising administering to a subject in need thereof cannabidiol (CBD), wherein the CBD has a purity of at least 98% (w/w) and comprises no more than 0.15% (w/w) Δ9-tetrahydrocannabidiol, wherein the CBD is administered at a dose of from 15 mg/kg/day to 20 mg/kg/day, wherein the CBD is administered as an oral composition comprising cannabidiol (CBD), a solvent, a co-solvent, a sweetener, and a flavoring, wherein the solvent is sesame oil, wherein the co-solvent is ethanol, wherein the CBD is present at a concentration of between 25 mg/ml and 100 mg/ml.”
The cited claims of USPN 10,709,671 do not specifically recite that the ethanol concentration is less than 1%.
Shah teaches as discussed above, and incorporated herein by reference.
The obviousness rationale is similar to the obviousness rationale of USPN 10,765,643 B2 over Kumar above, page 31.
Claims 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-18, 2-22, 24 of USPN 10,709,671 B2 in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892) as applied above to claims 1-6, 8-9, 13, 18, and 21, further, in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025).
The combination of the cited claims of USPN 10,709,671 B2 and Shah teaches a cannabinoid containing oral solution comprising a cannabinoid, a lipid solvent sesame oil, and ethanol, wherein the cannabinoid is present in a concentration of from 25 mg/mL to 100 mg/ml, and ethanol is less than 1%. The USPN 10,709,671 B2 and Kumar does not disclose that the lipid is olive oil, soybean oil or medium chain triglyceride.
Kumar teaches as discussed above and incorporated herein by reference.
The obviousness rationale is similar to the obviousness rationale of USPN 11,291,631 B2 over Kumar above, page 24.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9-18, 2-22, 24 of USPN 10,709,671 B2 in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892), and K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025), further, in view of C. Citti, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
USPN 10,709,671 B2, Shah and Kumar teach a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil or olive oil, wherein the cannabinoid is present in a concentration of from 25 mg/mL to 75 mg/ml. The combination of USPN 10,709,671 B2 and Kumar does not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above, and these teachings are incorporated herein by reference.
The obviousness rationale over Citti is similar to the obviousness rationale of claims 14-17 over USPN 10,849,860 B2 in view of K. Kumar, further in view of C. Citti, above, page 19.
Double Patenting over USPN 10,603,288 B2
Claims 1-6, 8-13, and 18-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of USPN 10,603,288 B2 in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 10% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
USPN 10,603,288 B2 recites in the conflicting claims “a method of treating seizures in a patient with treatment-resistant Lennox-Gastaut syndrome, comprising administering to the patient in need thereof cannabidiol (CBD), wherein the CBD has a purity of at least 98% (w/w) CBD, and wherein the CBD is administered at a dose of 5 mg/kg/day, and then the dose is increased by 2 to 5 mg/kg increments.”
While the cited claims of USPN 10,603,288 B2recite a cannabinoid for the treatment of seizures, however, cited claims of USPN 10,603,288 B2 do not recite formulating the cannabinoid in a composition. The cited claims of USPN 10,603,288 B2 does not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., 50 mg/ml.
However, one of ordinary skill in the art would have been motivated to formulate the cannabinoid in a composition comprising lipid solvent in view of Kumar and Shah.
Kumar and Shah teach as discussed above and incorporated herein by reference.
The obviousness rationale is similar to the rationale in the non-statutory Double Patenting Rejection above over USPN 11,207,292 B2 in view of K. Kumar and Shah, page 16. Claim 6 is obvious for the same rationale in the non-statutory Double Patenting Rejection over USPN 11,207,292 B2 in view of Kumar and Shah discussed on page 17 above. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
Claims 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of USPN 10,603,288 B2 in view of H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892) and K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) as applied above to claims 1-13, and 18-21, further in view of C. Citti, et al. Journal of Pharmaceutical and Biomedical Analysis, Volume 175, 2019, 112752, ISSN 0731-7085, “Citti” cited in the PTO-892 dated 05/22/2025).
The combination of cited claims of USPN 10,603,288 B2, Shah and Kumar teach a cannabinoid containing oral solution comprising a cannabinoid and a lipid solvent, sesame oil, soybean oil, olive oil, or medium chain triglyceride, wherein the cannabinoid is present in a concentration of from 25 mg/mL to 100 mg/ml. The combination of the cited claims of USPN 10,603,288 B2, Shah and Kumar do not disclose that the cannabinoid is CBD-C4.
Citti teaches as discussed above and incorporated herein by reference.
The obviousness rationale over Citti is similar to the obviousness rationale of claims 14-17 over claims 1-32 of USPN 10,849,860 B2 in view of K. Kumar, further in view of C. Citti, above, page 19.
Double Patenting over copending Application No. 19/102,763
Claims 1-6, 8-18, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of copending Application No. 19/102,763 (reference application) as evidence by Namayandeh, et al. (International Journal of Preventive Medicine, Vol 4, No 9, 2013, pages 1059-1062, “Namayandeh” cited in the PTO-892) in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025) and H. Shah (US PG-PUB 2019/0167583A1, 06/06/2019, “Shah” cited in the PTO-892). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid, a lipid solvent and ethanol, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml, and ethanol is present at less than 10% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
Copending Application No. 19/102,763 recites a drug substance, comprising about 65% w/w to about 95 %~ w/w of cannabidiol (CBD) based on the total weight of the drug substance; and THC, CBC, CBG, CBDV, CBD-C4, wherein the drug substance further comprises one or more terpenes, triglycerides, sterols, fatty acids, or carotenoids. copending Application No. 19/102,763 recites in claims 17-19, a pharmaceutical composition, comprising the drug substance of any one of claims 1-16 and a pharmaceutically acceptable excipient, wherein the pharmaceutically acceptable excipient is a carrier, diluent, adjuvant, filler, buffer, binder, disintegrant, preservatives, antioxidant, lubricant, stabilizer, solubilizer, surfactant, masking agent, coloring agent, flavoring agent, or sweetening agent, wherein the pharmaceutical composition is in a form of a liquid, a solution, a suspension, an emulsion, a syrup, an electuary, a mouthwash, a drop, a tablet, a granule, a powder, a lozenge, a pastille, a capsule, a cachet, a pill, an ampoule, a bolus, a suppository, a pessary, a tincture, a gel, a paste, an ointment, a cream, a lotion, an oil, a foam, a spray, or an aerosol. copending Application No. 19/102,763 recites in claims 20-22 a method of treating a neurological or neurodevelopmental disorder in a patient in need thereof, comprising administering the drug substance of any one of claims 1-16 or the pharmaceutical composition of any one of claims 17-19, wherein the neurological disorder or neurodevelopmental disorder is autism spectrum disorder (ASD), Alzheimer's Disease (AD),or psychiatric disorder, wherein the psychiatric disorder is psychosis, depression, or schizophrenia.
copending Application No. 19/102,763 triglyceride meets the definition of lipid solvent in instant claims 1 as evidenced by Namayandeh. copending Application No. 19/102,763 defines excipients to include ethanol. Copending Application No. 19/102,763 does not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., 50 mg/ml.
The obviousness rationale of having a concentration of 25-75 mg/ml is similar to the rationale in the non-statutory Double Patenting Rejection above over USPN 11,207,292 B2 in view of K. Kumar and Shah, page 16. The obviousness rationale of having ethanol in a concentration of less than 1% is similar to the obviousness rationale of USPN 10,765,643 B2 over Shah above, page 31. Claim 6 is obvious for the same rationale in the non-statutory Double Patenting Rejection over USPN 11,207,292 B2 in view of Kumar and Shah discussed on page 17 above. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Double Patenting over 18/002,437
Claims 1-6, 8-18, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13, and 20-33 of copending Application No. 18/002,437 (US20230225986A1) in view of K. Kumar et al. (WO 2016/191651 A1, 06/16/2016, “Kumar” cited in the PTO-892 dated 05/22/2025). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims 1-6, 8-18 recite “a cannabinoid containing oral solution which comprises a cannabinoid and a lipid solvent, wherein the cannabinoid is present in a concentration of from 25 to 75 mg/ml; wherein the solution further comprises ethanol at less than 1% w/v; wherein the oral solution produced Cmax greater than 250 ng/ml and AUCo-1 greater than 1250 ng.h/ml; wherein the cannabinoid is selected from CBC, CBCV, CBD, CBDA, CBDV, CBG, CBGV, CBL, CBN, CBNV, CBO, THC, THCA, THCV; THCVA; CBD-C1; CBD-C4; and CBD-C6; wherein the lipid solvent is hemp oil, olive oil, sesame oil, soybean oil, medium chain triglyceride, etc.; wherein the cannabinoid is CBDV, CBD-C4 and the edible oil is sesame oil, soybean oil, olive oil or medium chain triglyceride. claim 21 recites method of treating a disease or disorder selected from the group consisting of epilepsy and syndromes associated therewith, Dravet Syndrome, Lennox Gastaut Syndrome, etc., comprising administration of a cannabinoid containing oral solution according to any of the preceding claim 1.
The copending Application No. 18/002,437 recites in the conflicting claims “a method of treating childhood-onset epilepsy in a[[n]] patient in need thereof, comprising administering to the patient a pharmaceutical composition comprising a cannabidiol (CBD) drug substance comprising at least 98 % w/w CBD, wherein the patient is taking caffeine concurrently, wherein either the dose of CBD is reduced compared to a patient that is not taking caffeine concurrently, or the dose of caffeine is reduced compared to a patient that is not taking CBD concurrently, wherein the dose of CBD is reduced to dose ranging from about 5 mg/kg/day to about 20 mg/kg/day, herein the CBD drug substance comprises at least 98 % w/w CBD, not more than 0.15 % w/w CBDA, not more than 1.0% w/w CBDV, not more than 0.15 % w/w A9THC, and not more than 0.5 % w/w CBD-C4, wherein the childhood-onset epilepsy is selected from the group consisting of Lennox-Gastaut Syndrome; Myoclonic Absence Epilepsy; Tuberous Sclerosis Complex; Dravet Syndrome; Doose Syndrome; Jeavons Syndrome; CDKL5; Dupl5q;Neuronal ceroid lipofuscinoses (NCL) and brain abnormalities.”
While copending Application No. 18/002,437 recites a cannabinoid, CBD and CBD-C4 for the treatment of epilepsy is Lennox-Gastaut Syndrome, Dravet Syndrome, Tuberous Sclerosis Complex, etc., however, copending Application No. 18/002,437 does not recite formulating the cannabinoid in a composition. copending Application No. 18/002,437 does not specifically recite that the cannabinoid concentration is 25-75 mg/ml i.e., or that the composition comprises ethanol in a concentration of less than 1%.
However, one of ordinary skill in the art would have been motivated to formulate the cannabinoid in a composition comprising lipid solvent and less than 1% ethanol in view of Kumar and Shah.
Kumar and Shah teach as discussed above and incorporated herein by reference.
The obviousness rationale of having a concentration of 25-75 mg/ml is similar to the rationale in the non-statutory Double Patenting Rejection above over USPN 11,207,292 B2 in view of K. Kumar and Shah, page 16. The obviousness rationale of having ethanol in a concentration of less than 1% is similar to the obviousness rationale of USPN 10,765,643 B2 over Shah above, page 31. Claim 6 is obvious for the same rationale in the non-statutory Double Patenting Rejection over USPN 11,207,292 B2 in view of Kumar and Shah discussed on page 17 above. Claim 2 and 3 are obvious for the same rationale discussed on page 10 above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-6, 8-18, and 21 are rejected.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622