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 41-60 are currently pending and a preliminary amendment to the claims filed on 06/29/2023 is acknowledged.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/06/2023 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Claim Objections
Claims 47-48 and 51-53 are objected to a minor informality under 37 CFR 1.75.
Each of claims 47, 48 and 51-52 reciting “a topical formulation of claim 41” would be better to write “the topical formulation of claim 41”. Appropriate correction is requested.
Claim 53 recites “anti-oxidant affect”, but which would be better to write “anti-oxidant effect”.
Appropriate correction is requested.
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 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.
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)(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 41-60 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Avram (WO2021/240505A1, IDS of 09/06/2023, effective filing date: 2020-05-25) as evidenced by Parker et al., “Suppression of human macrophage interleukin- 6 by a nonpsychoactive cannabinoid acid”, Rheumatol Int., 2008 May: 28 (7):631-5, interleukin-6 (IL-6).
Applicant claims the below claim filed on 06/29/2023:
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Prior Art
Avam discloses a water-based compositions for topical administration and method of use thereof in order to relieve psoriasis of the scalp comprising a cannabinoid and at least one additional active ingredient (abstract, Example 1 and the claims); the compositions can be a pharmaceutical cmoposition for topical administration (page 6, line 15), and the compositions provide effective treatment without providing an unaesthetic appearance and without causing irritation to the scalp (page 3, lines 21-23), thus, which meets cosmetic and pharmaceutical purposes as claimed; and in one embodiment, the compositions comprise cannabidiol (CBD), BHT, EDTA, water, olive oil reading on the claimed additional antioxidant, hemp oil without the presence of alcohol (see the below Example 1); and the composition may be in the form of a liquid, provided in a bottle for spraying onto an affected area (page 5, lines 8-15).
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Avam further discloses that treatment of psoriasis of the scalp may involve treatment of symptoms including one or more than thickened, dry, scaly, flaky, cracked, itchy, red and/or inflamed skin (page 6, lines 27-28), and therefore said composition is effective to treat such symptoms, which means the composition can protect the skin with moisturizing, soothing, and/or anti-inflammatory effects; and with respect to anti-inflammatory effects, the claimed properties of reducing the expression of at least one pro-inflammatory cytokine in the epidermal layer of the skin would be implicit. As evidenced by Parker, interleukin-6 (IL-6) is a multifunctional cytokine which contributes to inflammation and tissue injury in several disease and cannabinoid prevents such joint damage in experimental arthritis and thus, this is an effective, safe anti-inflammatory agent” (see abstract). Thus, Avam as evidenced by Parker, the prior art composition suggests the composition would be implicitly effective to reduce the expression of cytokine, e.g., IL-6. Further, as to the claimed properties and intended uses, please note that if the prior art teaches the same composition as claimed, the claimed properties and/or intended uses must work in the prior art because "a chemical composition and its properties are inseparable”. Therefore, if the prior art teaches the identical composition, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Also see MPEP 2112 II: “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” (page 5 of the current OA). (instant claims 41-43 and 47-60).
Although Avam does not expressly teach storage stability of instant claim 44 and role of cannabinoid in the formulation of instant claims 45-46, it would also be inherent because Avam teaches the same composition as claimed. Thus, when the prior art composition is stored at room temperature, it would implicitly have had at least six month storage stability; and when the prior art composition is applied to skin, the cannabinoid would implicitly have had a preferential distribution to the epidermal layer of the skin of instant claims 45-46. See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Also see MPEP 2112 II noted above (instant claims 44-46).
In light of the foregoing, instant claims 41-60 are anticipated by Avam.
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.
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.
As indicated above, the present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 41-60 are rejected under 35 U.S.C. 103 as being unpatentable over Gardner (US2019/0255014A1) as evidenced by Parker et al., “Suppression of human macrophage interleukin- 6 by a nonpsychoactive cannabinoid acid”, Rheumatol Int., 2008 May: 28 (7):631-5, interleukin-6 (IL-6).
Applicant claims the below claim filed on 06/29/2023:
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Level of Ordinary Skill in the Art
(MPEP 2141.03)
MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). The level of skill is that of a medical/pharmaceutical/cosmetic skin care product research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, physiology and chemistry, and cosmetics — without being told to do so.
In addition, the prior art itself reflects an appropriate level (MPEP 2141.03(II)).
Determination of the scope and content of the prior art (MPEP 2141.01);
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02); and Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
Gardner teaches cosmetic and pharmaceutical formulations and compositions ([0038]) and discloses a topical formulation and method of applying it to the skin for treating skin conditions and/or enhancing the appearance of skin, wherein the formulation comprises at least one cannabinoid, skin protecting/enhancing ingredient, and carrier (seen entire document including claims 1, 5, 6, 8 of prior art); specifically, the formulation comprises at least one cannabinoid, EDTA as a chelating agent ([0066]), BHT and/or BHA as an antioxidant ([0068]), glycerin, fat, vegetable oils, plant oils as at least one skin protecting/enhancing ingredient (claim 8 of prior art), and water as the carrier ([0017]); and the formulation does not contain alcohol such as ethanol and/or methanol (see entire document).
However, Gardner does not expressly teach embodiments with specific ingredients as claimed. One of ordinary skill would be motivated to do this because a reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. Where, as here, the specific combination of features claimed is disclosed within the broad teachings of the reference but the reference does not disclose the specific combination of elements in a specific embodiment or in a working example, “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). However, "when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious". KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). "[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious", the relevant question is "whether the improvement is more than the predictable use of prior art elements according to their established functions." (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 "need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that "[a] person of ordinary skill is ... a person of ordinary creativity, not an automaton." Id. at 1742.
Here, Gardner teaches all the claimed ingredients for treating/improving skin condition, and therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to rearrange the disclosed elements and embodiments of the cited reference to prepare the instantly claimed composition. Such a rearrangement by a person of ordinary skill in the art who is not an automaton to yield the instantly claimed invention is within the purview of the ordinary skilled artisan upon reading the cited reference and would yield predictable results (instant claims 41-43).
Further, the prior art composition delivers cannabinoid transdermally in therapeutic amounts while simultaneously delivering skin protecting/enhancing ingredients which remain primarily on the top of the skin in order to protect, treat skin conditions and enhance the appearance of skin ([0038]), and the compositions contain cannabinoid and agents for protecting/enhancing skin appearance also improve inflammation, pain, cutaneous aging, oxidative effect, skin irritants, rashes, chapping, chaffing, bites, burns, cuts, and scrapes, etc. ([0008], [0011], [0033]); and the prior art also discloses methods of treating skin conditions and/or enhancing the appearance of skin by topically administering the composition in a single application or may be topically admininstered to a mammal in multiple applications ([0036]) (instant claims 47-49 and 51-53, 55, 56, 59 and 60); and the formulation is provided in the form of cream, gel, liquid, lotion, solution, spray, etc. ([0020]) (instant claim 50).
Although Gardner does not expressly teach properties and/or intended uses of instant claims 44-46, 54 and 57-58, those properties and/or intended uses would be implicit.
Specifically, Gardner does not expressly teach storage stability of instant claim 44 and role of cannabinoid in the formulation of instant claims 45-46, they would also be inherent because Gardner teaches the same composition. Therefore, when the composition is stored at room temperature, it would implicitly have had at least six month storage stability; and when the composition is applied to skin, the cannabinoid would implicitly have had a preferential distribution to the epidermal layer of the skin of instant claims 45-46, in the absence of evidence to the contrary. See "a chemical composition and its properties are inseparable”. Therefore, if the prior art teaches the identical composition, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990), and also see MPEP 2112 II Also see MPEP 2112 II: “There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).” (page 5 of the current OA) (instant claims 44-46).
With respect to anti-inflammatory effects, Gardner teaches such effects as noted above. Accordingly, the claimed properties of reducing the expression of at least one pro-inflammatory cytokine in the epidermal layer of the skin would be implicit. Even as evidenced by Parker, interleukin-6 (IL-6) is a multifunctional cytokine which contributes to inflammation and tissue injury in several disease and cannabinoid prevents such joint damage in experimental arthritis and thus, this is an effective, safe anti-inflammatory agent” (see abstract of Parker). Thus, Gardner as evidenced by Parker suggests the composition can be effective to reduce the expression of cytokine, e.g., IL-6. Further, as to the claimed properties and intended uses, please note that if the prior art teaches the same composition as claimed, the claimed properties and intended uses must work in the prior art because "a chemical composition and its properties are inseparable”. Therefore, if the prior art teaches the identical composition, the properties applicant discloses and/or claims are necessarily present.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Also see MPEP 2112 II as noted above (instant claims 54, 57 and 58).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yong (Brian-Yong) S Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYUNG S CHANG/ Primary Examiner, Art Unit 1613