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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 11 comprises the limitation “use according to claim 8 or 9”. Claim 8 and 9 have been canceled in the preliminary amendment filed on 10/10/23.
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.
Claim(s) 1, 4, 5, 6, 7, 10, 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shannon et al (The Permanente Journal, 2019, 23, article 18-041; submitted by applicant in with the IDS on 5/4/23). Shannon discloses treatment of subjects diagnosed with anxiety by daily administration of 50mg/d or 75mg/day of CBD. The agent was administered orally in capsule form for a period of at least a month (page 2, Methods and Procedures, paragraph 2).
Daily administration of 75mg/d of CBD for a period of at least a month to a subject with anxiety meets all of the limitations of claim 1.
Claims 4 and 5:
Claim 4 is directed to reduction of biomarkers for anxiety, stress and/or depression. Claim 5 is directed to reduction of biomarker for insomnia. Reduction in biomarkers is a direct consequence of administering the claimed dose of CBD. Since the subjects of Shannon are administered the claimed dose of CBD for the claimed duration of time, it is inherent that the biomarkers for anxiety, stress and/or depression, as well as biomarker for insomnia are reduced in the population treated by Shannon.
Claims 6, 7, 10, 11 and 12.
Claims 6, 7, 10, 11 and 12 are directed to a composition and to a kit comprising between 50mg and 200mg of CBD. Since Shannon discloses administration of a 50 and 75mg doses, the limitations directed to the contents of the composition and the kit are met. With regards to the kit, CBD is the only claimed component of the kit.
With regards to limitations directed intended use, which is treatment of psychological distress, limitations directed to intended use are not afforded patentable weight because they do not further limit the composition itself. It is well settled that the intended use of a composition or product (e.g. as a cosmetic composition) will not further limit claims drawn to a composition or product, so long as the prior art discloses the same composition comprising the same ingredients in an effective amount as instantly claimed. See, e.g., Ex parte Masham, 2 USPQ2d, 1647
Claim(s) 1 and 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heussler et al (Journal of neurodevelopmental disorders, 2019, 11:16; submitted with IDS on 5/4/23).
Heussler discloses reduction in general anxiety and depressed mood in subjects receiving a daily dose of 50mg, 100mg or 250mg for a duration of 12 weeks. (page 3, paragraph bridging columns 1 and 2; Table 3). Heussler uses ADAMS as a scale to measure the efficacy of reduction in anxiety and depression.
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.
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 and 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shannon et al (The Permanente Journal, 2019, 23, article 18-041; submitted by applicant in with the IDS on 5/4/23).
Scope of prior art
Shannon teaches treatment of subjects diagnosed with anxiety by daily administration of 50mg/d or 75mg/day of CBD. The agent was administered orally in capsule form for a period of at least a month (page 2, Methods and Procedures, paragraph 2). Daily administration of 75mg/d of CBD for a period of at least a month to a subject with anxiety meets all of the limitations of claim 1. In the same paragraphs Shannon also teaches treating subjects with sleep disorder by administering to the subjects a daily dose CBD. Both conditions were diagnosed by a mental health professional and assessed using the Hamilton Anxiety rating Scale and Pittsburg Sleep quality index.
Ascertaining the difference
Shannon teaches efficacy of CBD in treatment of anxiety and of sleep disorder, but does not exemplify a subject that has both, anxiety and sleep disorder.
Obviousness
A person of ordinary skill in the art prior to the earliest effective filing date of the current application, would have found it obvious to treat both sleep disorder and anxiety in the same subject by administering an effective amount of CBD. Shannon teaches that CBD reduces anxiety and treats sleep disorder. One would expect that both conditions would be improved in the same subject by administrating CBD. While Shannon does not recite “subject with insomnia”, but uses a more generic term “sleep disorder”, insomnia is the only sleep disorder identified in the reference as being treatable by administration of CBD (page 2, column 1, line 4).
Conclusion
Claims 1-7 and 10-12 are pending
Claims 1-7 and 10-12 are rejected
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628