DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Status
Claims 2, 3, 11-14, 16-18, 28, 33, 34, 41, 44, 46, 51, 56, 58, 60, 67, 75, 76, 79, and 83-93 are pending.
Priority
This application is filed 12/29/2023 and claims the benefit of domestic priority as below:
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Information Disclosure Statements
Three IDS(s) received on 12/29/2023, 07/01/2025, and 07/15/2025 have been considered unless marked with a strikethrough. The IDS filed on 07/01/2025, and 07/15/2025 are identical. The Examiner cross-out the IDS filed on 07/01/2025.
Claim Objections
Claims 33, and 79 are objected to because of the following informalities:
In the claim 33, the term “transdermal” list twice.
In the claim 79, the claim cites “a total daily dose of CBD selected from the group consisting of about 200 mg/day, about 350 mg/day, about 400 mg/day, about 700 mg/day, and about 1400 mg/day” Applying the definition of the term "about" which is +/- 10% of recited value in the specification, the ranges corresponding to 350 mg/day and 400 mg/day overlap. The overlapping ranges make the unclear for a total daily dose of CBD.
Appropriate correction is required.
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.
Claim(s) 2, 33, 34, 75, 76 and 79 are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Yucel et al. (US 2020/0246404 A1, pub’d 08/06/2020, cited in IDS), as evidenced by Bluthenthal et al. (“Opioid withdrawal symptoms, frequency, and pain characteristics as correlates of health risk among people who inject drugs”, Drug Alcohol Depend. 2020, 211, 107932, pub’d 03/18/2020) and the Medline article - Marinol (US national Library of Medicine, Dronabinol. MedlinePlus, https://medlineplus.gov/druginfo/meds/a607054.html, updated 09/15/2017).
This rejection applies because the embodiment disclosed in Yucel anticipates the pharmaceutical cannabinoid compositions comprising cannabinoids combined with lipid carriers and surfactant systems, and further teach therapeutic use, routes of administration, and dosage forms corresponding in claims 2, 33, 34, 75, 76 and 79.
With respect to claim 2, the claim recites that a method of treating Opioid Use Disorder (OUD) in a subject by administering a therapeutically effective amount of a pharmaceutical composition comprising at least one cannabinoid, at least one oil, at least one hydrophilic surfactant, at least one co-surfactant, and less than 1 wt% water.
Yucel recites that “the nausea and/or vomiting results from a chemotherapy, e.g., cancer chemotherapy. In another embodiment, the nausea and/or vomiting results from opioid use.” (Yucel’s specification, paragraph [0334]). Bluthenthal explains that opioid withdrawal is characterized by symptoms including nausea, vomiting, diarrhea, and anxiety (section 1.2 and 2.2). Thus, Bluthenthal provides evidence that nausea and vomiting are well recognized symptoms associated with opioid exposure and opioid withdrawal (section 1.2). Accordingly, under the broadest reasonable interpretation consistent with the specification, treatment of OUD reasonably encompasses treatment of symptoms resulting from opioid exposure or opioid withdrawal, including nausea and vomiting. (see MPEP 2111)
Furthermore, cannabinoids are known therapeutic agents for treating nausea and vomiting. For example, the FDA approved labeling for Marinol (i.e. dronabinol, MedlinePlus) states that dronabinol, a cannabinoid, is indicated for the treatment of nausea and vomiting. Thus, the Medline article - Marinol evidences that cannabinoids are effective for treating nausea and vomiting.
Therefore, Yucel discloses treatment of nausea or vomiting associated with opioid use, such disclosure reasonably encompasses treatment of symptoms associated with OUD, including nausea and vomiting, under the broadest reasonable interpretation of claims (see MPEP 2111), as evidenced by Bluthenthal which identifies nausea and vomiting are recognized symptoms associated with opioid exposure and withdrawal, and the Medline article - Marinol which demonstrates that cannabinoids are effective agents for treating nausea and vomiting.
Yucel further teaches a cannabinoid pharmaceutical composition comprising at least one cannabinoid, at least one oil, at least one hydrophilic surfactant, at least one co-surfactant, and less than 1 wt% water (paragraph [0017]-[0021], [0118], [0206], [0207], and claim 1). Yucel continually teaches that such composition improve dissolution, stability, absorption and/or oral bioavailability of cannabinoids using self emulsifying formulations and micellar dispersions for cannabinoid formulations (abstract).
Accordingly, Yucel teaches cannabinoid pharmaceutical compositions comprising cannabinoids, oils, surfactants, and co-solvents corresponding to the composition recited in claim 2.
With respect to claims 33 and 75, the claims recite routes of administration including oral administration.
Yucel teaches that the cannabinoid formulations are suitable for oral dosage forms, including solid, liquid, or semi-solid oral formulations (paragraph [0022]).
Therefore, Yucel teaches the administration route recited in claims 33 and 75.
With respect to claim 34, the claim recites that the cannabinoid is a non-psychoactive cannabinoid selected from including cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), cannabidivarin (CBDV), cannabinol (CBN), and derivatives thereof.
Yucel teaches cannabinoid compositions comparing various cannabinoids, including cannabidiol (CBD), cannabigerol (CBG), cannabichromene (CBC), cannabidivarin (CBDV), cannabinol (CBN), and derivatives as cannabinoid components suitable for the disclosed compositions (claim 34, and paragraph [0004], and [0272]).
Thus, Yucel teaches the cannabinoid species recited in claim 34.
With respect to claims 76 and 79, the claims recite dosage forms including capsules and soft gel capsules suitable for oral administration.
Yucel teaches encapsulated cannabinoid formulation including formulations suitable for gelatin capsules, and further explains that such compositions may reduce leakage when filled into gelatin capsules (paragraph [0166]).
Therefore, the encapsulated dosage forms recited in claims 76 and 79 are disclosed by Yuel.
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 2, 11-14, 16-18, 28, 41, 44, 46, 51, 56, 58, 60, 67, and 83-93 are rejected under 35 U.S.C. 103 as being unpatentable over Yucel et al. (US 2020/0246404 A1, pub’d 08/06/2020, cited in IDS), in view of Heinzerling et al. (WO 2019/099679 A1, pub’d 05/23/2019, cited in IDS).
With respect to claims 2, 11 and 12, the claims recite administration of the cannabinoid composition in conjunction with a second OUD medication, and reduction in requests for increased dosing.
As discussed above in anticipated rejections of claim 2, Yucel teaches a method of treating Opioid Use Disorder (OUD) in a subject by administering a therapeutically effective amount of a pharmaceutical compositions including cannabinoid, hydrophilic surfactant, co-surfactant, and less than 1 wt% water.
Yucel fails to teach co-administration of cannabinoids with a second OUD medication and reduction in requests for increased dosing.
Heinzerling teaches co-administration of cannabinoids with partial opioid agonists including buprenorphine, for the treatment of OUD and opioid withdrawal symptoms (abstract, and examples paragraph [0118]-[0132]). Heinzerling further teaches that such co-administration stabilized opioid therapy by improving symptom control and reducing withdrawal related effects. Stabilization of opioid therapy would reasonably be expected to result in a reduction in requests for increased dosing.
It would have been obvious to a PHOSITA at the time of the invention to combine the teaching of Yucel, which teaches administering the cannabinoid based treatment for OUD using self emulsifying formulations and micellar dispersions for specific cannabinoid formulations comparing oils, hydrophilic surfactants, and co-surfactants, with the teaching of Heinzerling, which teaches co-administration of cannabinoids with a second OUD medication including buprenorphine. Such a combination would have been motivated by the expectation that applying the improved cannabinoid formulations of Yucel to the cannabinoid therapies used in the treatment of OUD as taught by Heinzerling would improve dissolution, stability, absorption and/or oral bioavailability of the cannabinoids, thereby providing more reliable cannabinoid exposure and improved symptom control in patients undergoing OUD treatment (Yucel’s abstract). For example, Yucel teaches that the disclosed cannabinoid formulations improve dissolution and absorption of cannabinoids, while Heinzerling teaches that co-administration of cannabinoids with buprenorphine improves symptom control and stabilizes opioid therapy. Combining the improved cannabinoid delivery systems of Yucel with the co-administration therapy of Heinzerling would therefore reasonably be expected to enhance therapeutic effectiveness and stabilize opioid therapy, which would reasonably result in a reduction in requests for increased dosing.
The references is directed to the same field of endeavor and address related to the application. The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (A) in claims 11 and 12, it would have been prima facie obvious to administer the cannabinoid composition as taught by Yucel in combination with buprenorphine as taught by Heinzerling, with a reasonable expectation of predictable therapeutic effect in managing OUD. Accordingly, the claimed represents the use of known methods of formulation compositions according to known cannabinoid therapeutics, yielding predictable results. (see MPEP 2141)
With respect to claims 13, 14, 16-18, 28, and 83-93, the claims recite specific daily dose ranges, split dosing, split dosing regimens, and does escalation schedules of cannabinoids.
Heinzerling teaches administering therapeutically effective amounts of cannabinoids for OUD, including broad ranges of total daily doses and flexible dosing schedules (paragraph [0018], and [0091]). For example, the range of total daily dose of cannabinoid administered to the subject is between at 50 mg/day and 1400 mg/day, as required in claims 13, 14, 16-18, and Heinzerling teaches the subject is administered from 2 mg to 900 mg of administered cannabidiol or cannabidivarin that are daily amount in any range derivable therein. (paragraph [0018], and [0091]). Heinzerling further teaches that dosing may be administered as a single daily dose or as multiple doses per day and that the total daily dose may change over the course of treatment (paragraph [0086], [0087], and [0092]), as required in claims 28, and 83-93.
The claimed dose ranges and dosing regimens overlap with those disclosure by Heinzerling. Where the claimed range overlaps with a range disclosed in the prior art, the claimed subject matter is prima facie obvious. See MPEP 2144.05 incorporated by reference herein.
With respect to claim 41, 44, 46, 51, 56, 58, 60, and 67, the claims recite specific cannabinoids, concentration ranges, oils, hydrophilic surfactant, co-surfactants, and solvents used in the pharmaceutical composition.
Yucel teaches concentration ranges for cannabinoids, oils, hydrophilic surfactant, co-surfactants, and solvents that overlap with the ranges recited in the instant claims (paragraph [0122] – [0134]).
Selection of specific cannabinoids and concentration ranges of oils, hydrophilic surfactant, co-surfactants, and solvents overlap with those disclosure by Yucel. Where the claimed range overlaps with a range disclosed in the prior art, the claimed subject matter is prima facie obvious. The claimed compositions merely reflect the predictable use of known cannabinoids and known excipient ranges according to established formulation principles. See MPEP 2144.05 incorporated by reference herein.
Claims 2, and 3 are rejected under 35 U.S.C. 103 as being unpatentable over Yucel et al. (US 2020/0246404 A1, pub’d 08/06/2020, cited in IDS), in view of Hurd et al. (“Cannabidiol for the Reduction of Cue-Induced Craving and Anxiety in Drug-Abstinent Individuals With Heroin Use Disorder: A Double-Blind Randomized Placebo-Controlled Trial” Journal of Psychiatry, 2019, 176(11), 911-922, pub’d 05/21/2019, cited in IDS)
With respect to claim 3, claim recites reduction of OUD related symptoms, including cue induced carvings, anxiety, and negative affect that are evaluated by the subject's pre-treatment score, the Penn Alcohol-Craving Scale score, the negative affect scale score of the Positive and Negative Affect Schedule (PANAS), and the State subscale score of the Spielberger State-Trait Anxiety Inventory.
As discussed above, Yucel teaches a method of treating OUD in a subject by administering a therapeutically effective amount of pharmaceutical composition including cannabinoids and teaches pharmaceutical formulations that improve cannabinoid dissolution, absorption, and oral bioavailability, thereby enhancing therapeutic delivery of cannabinoids (Yucel, abstract).
Yucel does not teach a clinical evaluation of cue induced carving, anxiety or negative affect using specific assessment tools for OUD related symptoms.
Hurd teaches CBD’s potential to reduce cue-induced craving and anxiety provides a strong basis for further investigation of the phytocannabinoid as a treatment option for OUD (abstract). Hurd further teaches cue induced carvings, anxiety, and negative affect that are evaluated by cue-induced craving (VAS-C), Cue-induced anxiety (VAS-A), and Negative affect scores (PANAS) (result section).
It would have been obvious to a PHOSITA at the time of the invention to apply the cannabinoid based treatment methods for OUD using the bioavailability enhancing pharmaceutical formulations taught by Yucel, and to evaluate the resulting therapeutic effects on cue induced carvings, anxiety, and negative affect using standardized clinical assessment tools taught by Hurd. Such combination would have been motivated by the expectation that improving cannabinoid dissolution, stability, absorption, and oral bioavailability as taught by Yucel would enhance therapeutic cannabinoid exposure, while the standardized clinical assessment tools taught by Hurd would allow reliable and clinically meaningful evaluation of reductions in carving, anxiety, and negative affect.
Applying KSR example rationale (A), it would have been prima facie obvious to combine the CBD based formulated therapeutic methods taught by Yucel, and evaluated using established clinical assessment tools for cue induced carvings, anxiety, and negative affect taught by Hurd, with a reasonable expectation of predictable therapeutic outcomes in treating OUD.
Conclusion
Claims 2, 3, 11-14, 16-18, 28, 33, 34, 41, 44, 46, 51, 56, 58, 60, 67, 75, 76, 79, and 83-93 are rejected.
Claims are 33, and 79 are objected to.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571)272-6918. The examiner can normally be reached 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621