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 .
Status of Claims
Claims 1-16 are pending in the instant application.
Priority
This application is a continuation of Application No. 17065851, filed October 8th, 2020, which claims priority to provisional Application No. 62913874, filed October 11th, 2019.
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 01/30/2025, 05/12/2025 and 05/11/2026 were considered by the Examiner.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: how to select a patient in need of treatment of a seizure disorder. Claims 2-8 do not clarify the essential method steps and, as such, are also rejected as being indefinite.
Regarding claims 2-3, the phrases "for example" and “such as” render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 1 and 9 recite the limitation "the active components". There is insufficient antecedent basis for this limitation in the claim. Claims 2-8 and 10-16 do not resolve the lack of antecedent basis and are also rejected as being indefinite.
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.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Aung-Din et al (WO 2016/141056 A1, published September 9th, 2016) in view of Nowak et al (WO 2020/016656 A2, which claims priority to PCT/IB2019/000847, filed July 16th, 2019 and claims priority to 62/700,107, filed July 18th, 2018).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Aung-Din teaches a method of treating a disease state or condition in a human with a cannabinoid drug comprising administering a cannabinoid drug in a therapeutically effective amount to treat the disease state or condition (claim 1). Aung-Din teaches that the disease state of condition is seizures (claim 27). Aung-Din teaches that the cannabinoid is THC (paragraph [0063]) and that the cannabinoid drug in the topical formulation are at a concentration from about 0.75% to about 5% by weight (paragraph [0004]). Further, Aung-Din teaches that the delivery of the drug is through a sustained release patch (paragraph [0021]) and that the patch releases the cannabinoid drug(s) over time such that the cannabinoid drug(s) is absorbed at the back of the neck in therapeutically effective amounts over a span of multiple dosage time intervals (e.g., 1-7 days) (paragraph [0094]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Aung-Din does not explicitly teach that the THC is highly purified, comprising at least about 90% (w/w) THC.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Aung-Din does teach that the drug may be in a pure form (paragraph [0040]).
Further, Nowak teaches a composition for extended release of one or more cannabinoids (claim 1). Nowak further teaches that the cannabinoid is THC (claim 2) and that the THC comprises about 90% w/w (claim 22). Nowak further teaches that the composition is used for treating epilepsy, a seizure disorder (claim 29).
Regarding claim 1, thus, as Aung-Din teaches a method for the treatment of a seizure disorder, with a transdermal extended release patch containing a cannabinoid, THC, in a general amount of purity one of ordinary skill in the art looking to optimize the general teachings of Aung-Din would look to Nowak to alter the THC purity to be over 90%, as Nowak teaches a method of treating a seizure disorder with an extended release drug containing THC with a purity of 90% and arrive at the instant invention.
Regarding claims 2-3, Aung-Din teaches the treatment of a patient diagnosed with complex partial seizures with secondary generalization (Example 14).
Regarding claims 4 and 7, Aung-Din teaches that the drug is releases at a constant rate (paragraph [00173]), administered once a week.
Regarding claim 5, Aung-Din teaches a prolonged or sustained release formulation (e.g., a transdermal patch or contained in liposomes) that releases the cannabinoid drug(s) over time such that the cannabinoid drug(s) is absorbed at the back of the neck in therapeutically effective amounts over a span of multiple dosage time intervals (e.g., 1-7 days) (paragraph [0094]).
Regarding claim 6 and 8, Aung-Din teaches that the patch is traditional and establishes a therapeutic drug blood level (paragraph [0089]).
Regarding claim 9, as seen above, Aung-Din teaches a transdermal patch with THC and it would have been obvious to use highly purified THC as motivated by the teachings of Nowak. Aung-Din further teaches that the composition includes at least 5% of the cannabinoid (claim 22), 2-25% propylene glycol in combination with oleic acid (paragraph [00160]), butylated hydroxytoluene as an adjuvant/carrier (paragraph [00148]) as a remaining weight portion comprising less than 20% (paragraph [00132]) and 50% of a pressure-sensitive adhesive (paragraph [00159]) and at a pH of 5 (paragraph [00139]). Also, Nowak teaches that the composition includes silicone dioxide as a filler at differing weight percentages up to 80% (paragraph [0058], Table 4). Further, as seen above, Aung-Din teaches that the drug is sustained over the course of 7 days. While the weight percentages may not be as exact as instantly claimed, one of ordinary skill would have been motivated to optimize the teachings, as the ranges do overlap. See MPEP 2144.05.
Regarding claims 10-11, as seen above, Aung-Din teaches that adjuvants/carriers are present (paragraph [00148]) as a weight portion comprising less than 20% (paragraph [00132]).
Regarding claim 12, “for the treatment” is intended use and the claim limitations are presumed met by the composition of claim 9. However, in interest of compact prosecution, as seen above, Aung-Din teaches that the composition is used to treatment complex partial seizures.
Regarding claim 13, Aung-Din teaches that the composition can be administered once a week (paragraph [0012]).
Regarding claim 14, Aung-Din teaches that the THC can be synthetically produced (paragraph [0054]).
Regarding claims 15-16, Aung-Din teaches that an additional drug can be administered, including phenobarbital (paragraph [0008]).
Conclusion
No claim is allowed.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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