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 .
Election/Restrictions
Acknowledgement is made to Applicant’s response filed 08/01/2025.
Claims 1-12 and 15-22 are pending.
Claims 15-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/01/2025.
Claims 1-12 are currently under consideration to the extent that they read upon Applicant’s elected species.
NOTE: Applicant elected –
cannabidiol (CBD) and tetrahydrocannabinol (THC) are elected as the first component
histamine dihydrochloride, camphor, menthol, and primrose oil are elected as the second component
aloe vera, black pepper essential oil, vitamin E, isopropyl palmitate, and caprylic/capric triglyceride ("a mixed ester of caprylic and capric fatty acids attached to a glycerin backbone" as defined at page 13, lines 18-19, of the specification) are elected as the third component
fragrance, alcohol, and water are elected as the additional components.
Upon further search and examination the species election over second component is broadened to include, a salicylate, camphor, menthol, and any combination thereof as well as a third component is broadened to include a propylene glycol, cetearyl alcohol, glyceryl stearate, a ceteareth, polyethylene glycol stearate, dimethicone, octyldodecanol, lecithin, ethylhexylglycerin, phenoxyethanol, and medium chain triglyceride (MCT) oil.
Specification
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/01/2024,06/28/2023, and 01/17/2023 are being considered by the examiner. The submission is in compliance with the provisions of 37 CFR 1.97.
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.
Claim 12 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.
Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by AVRAM (US 20210046040 A1; also available as WO2020012480A1).
AVRAM discloses compositions comprising active agents to provide pain relief (abstract). AVRAM teaches compositions comprising one cannabinoid or multiple cannabinoids, such as a combination of CBD and THC (see entire document, for instance, [0018], claim 5). AVRAM discloses additional analgesic agents such as camphor, capsaicin, capsicum, capsicum oleoresin, methyl salicylate, histamine dihydrochloride, menthol, trolamine salicylate (see entire document, for instance, [0021], claim 2).
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.
Claim(s) 1-7 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over by AVRAM (US 20210046040 A1; also available as WO2020012480A1) and EADES et al (US 20200197358 A1).
AVRAM discloses compositions comprising active agents to provide pain relief (abstract). AVRAM teaches compositions comprising one cannabinoid or multiple cannabinoids, such as a combination of CBD and THC (see entire document, for instance, [0018], claim 5). AVRAM discloses additional analgesic agents such as camphor, capsaicin, capsicum, capsicum oleoresin, methyl salicylate, histamine dihydrochloride, menthol, trolamine salicylate (see entire document, for instance, [0021], claim 2). AVRAM teaches compositions described herein may further comprise a vitamin, a natural oil, a triglyceride, glyceryl stearate, phenoxyethanol ([0056], [0030]). However, it a does not expressly disclose including a vitamin, a natural oil, a triglyceride such as black pepper essential oil, vitamin E, caprylic/capric triglyceride, medium chain triglyceride (MCT) oil or primrose oil. EADES et al remedy this deficiency.
EADES discloses a formulation containing a cannabinoid or cannabinoid analogue in a delivery system, wherein the delivery system includes a mixture of at least one lipid and at least one surfactant (see entire document, for instance, abstract). EADES teaches the cannabinoid or cannabinoid analogue comprises at least one of delta-9-tetrahydrocannabinol [THC] and cannabidiol [CBD] (see entire document, for instance, claim 2). EADES teaches dosage forms include ointments, pastes, creams, lotions, gels ([0060]). EADES discloses transdermal patches have the added advantage of providing controlled delivery of a compound of the present invention to the body ([0063]). EADES teaches primrose oil ([0035]). EADES discloses composition can be used for alleviating pain (see entire document, for instance, [0065]). EADES teaches those that can solubilize or assist in solubilizing the active(s) or provide a stabilizing effect. Examples of suitable lipids include, but are not limited to, medium-chain glycerides, a long-chain glycerides, caprylic/capric triglycerides, a propylene glycol fatty acid ester and mixtures thereof (see entire document, for instance, [0033]- [0034], claim 12). EADES discloses isopropyl palmitate ([0042]).
It would have been obvious to utilize vitamin E, caprylic/capric triglyceride, medium chain triglyceride (MCT) oil or primrose oil as taught in EADES in the composition of AVRAM. One would have been motivated to do so since EADES teaches that lipids can solubilize or assist in solubilizing the active(s) or provide a stabilizing effect. There would be a reasonable expectation of success since AVRAM and EADES are both drawn to compositions for compositions comprising active agents to provide pain relief.
Regarding instant claims 4 and 5, AVRAM discloses cannabinoids can be manufactured synthetically ([0018]).
Regarding instant claim 10, AVRAM teaches compositions may further comprise fragrance, water ([0023]).
Regarding instant claim 11, AVRAM discloses analgesics may be administered topically, in the form of a cream, ointment, gel, or lotion (see entire document, for instance, [0018], claim 28).
Claim(s) 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over by AVRAM (US 20210046040 A1; also available as WO2020012480A1) EADES et al (US 20200197358 A1) and further in view of Fuladi (US 20190380956 A1)
The teachings of AVRAM et al and EADES et al have been set forth above. However, it a does not expressly disclose including aloe vera or black pepper essential oil. Fuladi et al remedy this deficiency.
Fuladi teaches a topical composition for nociceptive and neuropathic pain relief comprises several of menthol, camphor, ethyl salicylate or capsaicin with Cannabis sativa (see entire document, for instance, abstract). Fuladi discloses methyl salicylate, Aloe vera, isopropyl palmitate, Piper nigrum (black pepper) oil, menthol, camphor, ([0015] - [0018]. Thus, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the composition as described by Fuladi with the composition of AVRAM et al and EADES et al. One would be motivated to do so with a reasonable expectation of success in combining prior art elements according to known methods to yield predictable results; in the instant case for its known anti-inflammatory uses.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET JOSEPH whose telephone number is (571)270-1372. The examiner can normally be reached Monday and Thursday 0730-1730 Eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham, can be reached at (571)272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET JOSEPH/Patent Examiner, Art Unit 1611
/TREVOR LOVE/Primary Examiner, Art Unit 1611