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 the Application
Applicant's election of Group I, drawn to a method of treating a condition characterized by anandamide deficiency by administering a composition comprising at least one modulator, in the reply filed on 7/22/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Upon further consideration, the species requirement is hereby withdrawn.
Claims 1-19 are pending. Claims 1-8 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 9-19 are examined herein insofar as they read on the elected invention.
Claim Objections
Claim 9 is objected to because of the following informalities: Please insert a comma between “anadamide” and “N-Oleoylethanolamine”. Appropriate correction is required.
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.
Claims 9-15, 17-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shmulewitz et al. (US Patent Application 2018/0078523, of record).
Shmulewitz et al. teach a method of preventing or treating pain in a human subject by administering a pharmaceutical composition comprising at least one cannabinoid and at least one N-acylethanolamine in a molar ratio between about 1:0.2 tp 1:2000 (claim 74). A preferred cannabinoid is cannabidiol (CBD) (claim 80) and a preferred N-acylethanolamine is oleoylethanolamine (OEA) (claim 84). In certain embodiments, the pharmaceutical composition comprises about 0.5-10 mg of cannabinoid, specifically 1, 2.5, 5, 10 mg of cannabinoid (paragraphs 0019, 0065). Pharmaceutically acceptable carriers are also taught (paragraphs 0055, 0057). The pain encompasses unpleasant sensory and emotional experience associated with actual or potential tissue damage (paragraph 0093).
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Shmulewitz et al. (US Patent Application 2018/0078523, of record) in view of Barr et al. (US Patent 6,197,823).
The instant claims are directed to a method of treating a condition characterized by anandamide deficiency by administering a composition comprising at least one modulator.
Shmulewitz et al. teach as discussed above, however, fail to teach at least one terpene (menthol) and wherein at least one modulator and cannabidiol are administered in separate compositions.
Barr et al. teach that menthol is known to act as an analgesic (col. 5, lines 16-17).
Therefore, it would have been prima facie obvious to a person of ordinary skill in the art, prior to the effective filing date of the claimed invention, to have combined menthol, as taught by Barr et al., with separate compositions of CBD and OEA used for the treatment of pain, as taught by Shmulewitz et al.
A person of ordinary skill in the art would have been motivated to combine menthol with CBD and OEA because all three are individually known to be useful for the treatment of pain. Therefore, one of ordinary skill in the art would have had a reasonable expectation of success in treating pain with the therapeutically additive effect of CBD, OEA, and menthol. Furthermore, administering known active agents separately or in a single composition is known in the art and is subject to routine experimentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Yong S. Chong whose telephone number is (571)-272-8513. The examiner can normally be reached Monday to Friday: 9 AM to 5 PM EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached at (571)-270-7674. The fax phone number for the organization where this application or proceeding is assigned is (571)-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at (866)-217-9197 (toll-free).
/Yong S. Chong/Primary Examiner, Art Unit 1623
Prosecution Insights