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 .
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.
Current Status of 17/779,122
This Office Action is responsive to the amended claims of 6 February 2026.
Claims 1, 6-9, 13, 18, and 23-32 are currently pending.
Priority
Applicant’s claim for the benefit of the prior-filed patent applications PCT/US2020/061848 (filed 23 November 2020) and 62/938,877 (filed 21 November 2019) under 35 U.S.C. 119(e), 120, 121, 365(c), or 386(c) is acknowledged.
Information Disclosure Statement
As of 24 April 2026, Applicant has not submitted an Information Disclosure Statement.
Response to Amendments
The objections to the drawings, present in the previous office action, are hereby withdrawn due to the replacement drawing sheets.
The objections to the specification, present in the previous office action, are hereby withdrawn due to Applicant’s amendments.
The objections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s cancellation of those claims.
The 35 U.S.C. 112 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments and cancellation of claims.
The 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections under 35 U.S.C. 102 are presented as necessitated by Applicant’s amendments.
The 35 U.S.C. 103 rejections to the claims, present in the previous office action, are hereby withdrawn due to Applicant’s amendments. New rejections under 35 U.S.C. 103 are also presented herein, as necessitated by Applicant’s amendments.
Response to Arguments
Applicant argues that COSTINIUK does not disclose a composition comprising CBD and cobicistat. Applicant argues that COSTINIUK is describing a proposed trial, and the Examiner’s reliance on inherent effects stemming from administration of therapeutics in a proposed trial is “misplaced”. Applicant argues that COSTINIUK “simply alludes to not excluding” individuals from the trial therein if they were taking cobicistat, and does not require such individuals to be present in the trial. Applicant argues that, even if COSTINIUK taught the administration of cobicistat and CBD, this would not form a composition, because CBD and THC would be physically separate. Applicant argues that cobicistat, lansoprazole, and 6,7-dihydroxybergamottin each provide an unexpected synergistic benefit when combined with CBD. Applicant argues, at length, that COSTINIUK is a proposed trial and does not provide results from the trial.
The Examiner has withdrawn all previous rejections, so some of Applicant’s arguments are no longer applicable to the rejections herein. Applicant’s argument that COSTINIUK is a proposed trial is not sufficient to overcome any of the current rejections. The teachings of COSTINIUK are valid teachings without results being provided, although the lack of results may have caused one of ordinary skill in the art to give the disclosure of COSTINIUK less weight at that time. The Examiner clearly addresses why one of ordinary skill in the art would combine CBD and cobicistat into a single physical capsule below. It would have been reasonable for one of ordinary skill in the art to envisage testing different combinations of the multiple therapeutic agents that were taught by COSTINIUK to be beneficial to a single patient. Because THC, CBD, and cobicistat are specifically named as being administered to a single patient, it would have been reasonable for the artisan to envisage: the single combination drug product containing all three agents, and the 2 additional combination drug products with 2 components not specifically discussed by COSTINIUK. COSTINIUK clearly proposed a patient being administered THC, CBD, and cobicistat, even if the cobicistat was not intended to be administered by the CBD/THC trial personnel. Applicant’s comments about an unexpected synergistic benefit were considered by the Examiner. The synergistic benefits are not determined to be sufficient to overcome the instant rejections.
Claim Rejections - 35 USC § 102
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, 8-9, 27-28, and 31-32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
BRYSON (WO 2008/151415 A1, International Publication Date 18 December 2008).
BRYSON teaches a method of treating a diabetic condition through the administration of a proton pump inhibitor and an anti-inflammatory drug (claim 1 therein), wherein the anti-inflammatory drug is cannabidiol (claims 14-15 therein) and the proton pump inhibitor is lansoprazole (claim 23 therein). BRYSON teaches solid-dose formulations of the inventions therein including excipients (paragraph [0039]).
Regarding claims 8-9 and 31-32: The methods of claims 8-9 and 31-32 are understood to be limited by the steps described therein. The prior art above renders obvious CBD treatment and the administration of the claimed compositions. Because all of the positive steps that can be performed by the artisan are rendered obvious, the outcomes of the administration of the claimed compositions, being decreased hepatotoxicity or increased CBD plasma levels, are rendered obvious as well.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 6-9, 13, 18, and 23-32 are rejected under 35 U.S.C. 103 as being unpatentable over:
COSTINIUK (Costiniuk, C.T.; Saneei, Z.; Routy, J.P.; et al. “Oral cannabinoids in people living with HIV on effective antiretroviral therapy: CTN PT028—study protocol for a pilot randomised trial to assess safety, tolerability and effect on immune activation” BMJ Open 2019;9:e024793)
in view of:
KOO (Koo, O. "Manufacturing Process Considerations for Fixed-Dose Combination Drug Products" The Review of American Pharmaceutical Business & Technology, 1 April 2010).
COSTINIUK teaches a clinical trial, wherein THC and CBD are administered at varying ratios to a population of patients having persistent HIV infections (abstract). THC and CBD are taught by COSTINIUK to be administered while the patients continue their antiretroviral therapy regimens (title and Pg. 4). COSTINIUK specifically teaches the combination of CBD administration concurrently with cobicistat-protease inhibitor administration in the following excerpt, beginning at the bottom right of Pg. 4:
“The investigators will review potential participants’ current medication lists at the screening visit. If any concomitant therapy interacts with the study medication, and if this therapy cannot be substituted, that participant will not be eligible to enrol [sic] in the study. Although some HIV antiretroviral drugs/pharmacokinetic ‘boosters’ are metabolised by the CYP1A2 and CYP3A4 (eg, ritonavir and cobicistat-boosted [protease inhibitors]), suggesting that a drug interaction may occur, in real practice at the CVIS, no clinically significant drug interactions have been observed in patients reporting heavy cannabis use. Therefore, individuals will not be precluded to participate based on their specific antiretroviral regimen.”
One of ordinary skill in the art would understand this excerpt to indicate that patients receiving cobicistat-boosted protease inhibitor antiretroviral therapy are specifically taught to be included in the clinical trial of COSTINIUK. COSTINIUK teaches that the CBD and THC therein are administered within capsules (1st paragraph Pg. 4). The capsule material is a pharmaceutically acceptable excipient.
KOO teaches fixed-dose combination (FDC) drug products to be of interest to the pharmaceutical industry. KOO states that these FDC drug products are useful to improve patient compliance by reducing the pill burden on the patient (introduction section).
It would have been obvious to one of ordinary skill in the art, before the instant effective filing date, to see the multiple therapeutic agents being administered to a single patient in COSTINIUK, including THC, CBD, and cobicistat, and envisage fixed-dose combination drug products being tested for all combinations of these therapeutic agents, for the purpose of increasing patient compliance (as taught by KOO). The artisan would have expected success in the strategy of testing the administration of these combinations, because KOO directly teaches that combining multiple active components improves patient compliance.
Regarding claims 6-7, 23-24, and 29-30: The “Study intervention” section of COSTINIUK teaches that the doses used therein are equivalent to those used in a clinical trial for neuropathic pain. The same section also teaches that CBD was used to treat patients with Lennox-Gastaut syndrome (a type of epilepsy). One of ordinary skill in the art would have understood that the administration of the pharmaceutical combinations rendered obvious by COSTINIUK and KOO would be beneficial to any patients also suffering from neuropathy pain or epilepsy.
Regarding claims 8-9, 25-26, and 31-32: The methods of claims 8-9, 25-26, and 31-32 are understood to be limited by the steps described therein. The prior art above renders obvious CBD treatment and the administration of the claimed compositions. Because all of the positive steps that can be performed by the artisan are rendered obvious, the outcomes of the administration of the claimed compositions, being decreased hepatotoxicity or increased CBD plasma levels, are rendered obvious as well.
Conclusion
No claims are currently allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN D MCANANY whose telephone number is (571)270-0850. The examiner can normally be reached 8:30 AM - 5:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ANDREW D KOSAR can be reached at (571)272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JDMc/Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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