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 .
DETAILED ACTION
Claims 1-19 are pending in the present application file.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement filed 12/24/2023 has been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
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 19 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.
The term “improvement” in claim 19 is a relative term which renders the claim indefinite. The term “improvement” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. There is no guidance to ascertain the degree of improvement in skin hydration, skin moisturization, skin redness, soothing and skin smoothness required to arrive at the claim. As such the metes and bounds are unclear to one of ordinary skill in the art.
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 1-9, 13-16 and 18 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Baillo (US 2020/345686 A1; Baillo et al.; Date Published: 11/5/2020; Filing Date: 4/28/2020).
Baillo discloses a method for treatment of a patient suffering from a diabetic related conditions (discloses a method for treating skin or neurological conditions comprising pain and diabetic neuropathy, see paragraphs 38, 57 and claims 17 and 45) comprising administering to the patient a composition comprising a cannabinoid (discloses topical compositions comprising a cannabinoid including CBD – see paragraph 62-75), applied via the topical route to the patient (see claims 24-28). See instant claims 1 and 13-14.
Baillo discloses wherein the composition is in the form of lotions, gels, salves, liniments, ointments, creams and others. See paragraphs 92-94. See instant claim 2.
Baillo discloses where the amount of cannabinoid, in weight percent (w %), in the composition is between about 0.01% and about 5% of the composition. See paragraph 75. See instant claims 3-4.
Baillo discloses a composition comprising at least one analgesic component and at least one cannabis component, where the analgesic component is capsaicin. Baillo also discloses where the capsicum is present in an amount 0.1-1.5%. See paragraphs 4 and 109-115 as well as claims 1-3. See instant claims 5-7.
Baillo discloses where the composition further comprises beeswax, lanolin. See instant claims 8-9.
Baillo also discloses wherein the composition is administered to the foot once to twice daily by a patient. See paragraph 57 and 128-129. See instant claims 15-16.
Baillo discloses formulation comprising cannabinoid and hydrolyzed oats (for skin hydration), moisturizer (including MCT oil, aloe vera and medical cannabis; see paragraph 120-121), soothing and skin smoothness. See paragraph 20 and Examples 1-2. See instant claim 19.
Regarding claim 18, the limitation “for enhancing blood flow” is interpreted as an intended outcome in treating a patient suffering diabetes. The active steps of the method recite the limitation of administering to the diabetes patient a composition comprising a cannabinoid, applied via the topical route to the skin. As Baillo discloses the administration of a composition comprising a cannabinoid to a patient suffering from diabetes via the topical route, the instant claim is anticipated.
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 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Baillo (US 2020/345686 A1; Baillo et al.; Date Published: 11/5/2020; Filing Date: 4/28/2020), in view Yardley (US 2021/052478 A1; Yardley et al.; Date Published: 2/25/2021; Date Filed: 7/6/2020) and Oliver’s Harvest (Oliver's Harvest, certified foot and ankle specialist, LLC: "The 7 Ways CBD Oil Helps Foot Problems", posted online by Oliver's Harvest, retrieved from URL: https://certifiedfoot.com/podiatry-and-cbd-foot-problems/, 01 Jun 2020 (2020/06/01))
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Baillo discloses a method for treatment of a patient suffering from a diabetic related conditions (discloses a method for treating skin or neurological conditions comprising pain and diabetic neuropathy, see paragraphs 38, 57 and claims 17 and 45) comprising administering to the patient a composition comprising a cannabinoid (discloses topical compositions comprising a cannabinoid including CBD – see paragraph 62-75), applied via the topical route to the patient (see claims 24-28). See instant claims 1 and 13-14.
Baillo discloses wherein the composition is in the form of lotions, gels, salves, liniments, ointments, creams and others. See paragraphs 92-94. See instant claim 2.
Baillo discloses where the amount of cannabinoid, in weight percent (w %), in the composition is between about 0.01% and about 5% of the composition. See paragraph 75. See instant claims 3-4.
Baillo discloses a composition comprising at least one analgesic component and at least one cannabis component, where the analgesic component is capsaicin. Baillo also discloses where the capsicum is present in an amount 0.1-1.5%. See paragraphs 4 and 109-115 as well as claims 1-3. See instant claims 5-7.
Baillo discloses where the composition further comprises beeswax, lanolin. See instant claims 8-9.
Baillo also discloses wherein the composition is administered to the foot once to twice daily by a patient. See paragraph 57 and 128-129. See instant claims 15-16.
Baillo discloses formulation comprising cannabinoid and hydrolyzed oats (for skin hydration), moisturizer (including MCT oil, aloe vera and medical cannabis; see paragraph 120-121), soothing and skin smoothness. See paragraph 20 and Examples 1-2. See instant claim 19.
Regarding instant claim 18, the limitation “for enhancing blood flow” is interpreted as an intended outcome in treating a patient suffering diabetes. The active steps of the method recite the limitation of administering to the diabetes patient a composition comprising a cannabinoid, applied via the topical route to the skin. As Baillo provides the administration of a composition comprising a cannabinoid to a patient suffering from diabetes via the topical route, the instant claim is disclosed.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Baillo does not disclose where skin protectant in the composition is dimethicone, petrolatum or glycerin. See instant claims 10-12.
Baillo does not disclose wherein the amount of the composition administered is between 0.1-15 g per administration. See instant claim 17.
Finding of prima facie obviousness --- rationale and motivation (See
MPEP § 2142-2143)
Yardley discloses methods of treating symptom associated with disease, disorder or condition relating to chronic or acute pain, including diabetic neuropathy, comprising administration of a composition comprising a cannabinoid to the skin. See paragraphs 13-21 and 75.
Yardley discloses where the topical cannabinoid composition further includes dimethicone and petrolatum. See paragraphs 47-57 and 63-69. See instant claims 10-11.
Oliver’s Harvest discloses a topical cream (see recommended product: CBD with capsaicin) comprising CBD, capsaicin, glycerin and dimethiconol for treating foot problems which may result from diabetic neuropathy. See CBD with capsaicin product description: (https://web.archive.org/web/20200928084050/https:/oliversharvest.com/cbd-capsaicin-cream/). Olivers’ Harvest discloses where the cream is applied to the skin (such as the foot) 3 or 4 times daily for patients. See instant claim 12.
It is prima facie obvious to combine Baillo, Yardley and Oliver’s Harvest as they are all directed to methods comprising topical administration of a cannabinoid composition to patients suffering from diabetes or symptoms of diabetes. One of ordinary skill in the art would have a reasonable expectation of success in treating a patient suffering from a diabetic related condition or diabetes with topical administration of a composition comprising a cannabinoid. As the prior art references provide exemplary compositions and working examples demonstrating the success of topical administration of the cannabinoid compositions, the present claims are prima facie obvious.
"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05,II.A.
Regarding claim 17, although Baillo is silent in the amount of composition provided per administration to the patient, Baillo provides compositions in the total mass between 20-45g as well as guidance for the amount of cannabinoid present in the composition per administration. One of ordinary skill in the art would have adjusted the appropriate dosage during routine optimization to achieve the desired treatment outcome.
"Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. See MPEP 2112.01(II).
Regarding claim 19, As Baillo discloses the steps of administration of the composition comprising a cannabinoid, applied to the topical route to the skin, as well as balms and salves to treat, heal and sooth the skin, Baillo discloses a composition which has the properties to improve skin hydration, moisturization, redness, soothing and smoothness. Products of identical composition cannot have separate properties. The degree of improvement required by the claim or disclosure is not defined and one of ordinary skill in the art would have a reasonable expectation of success towards achieving the intended results of instant claim 19 based on the guidance of Baillo. The instant claim does not address steps in the embodiments in the method for treatment of a patient suffering from a diabetic related condition where the patient does not experience these desired outcomes.
As such, the instant claims are prima facie obvious and properly rejected.
Conclusion
Claims 1-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626