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 Status
Claims 1-4 are currently pending.
Priority
This application is filed 11/03/2023 and claims the benefit of domestic priority over US Provisional Application 63/422,114 filed 11/03/2022.
Information Disclosure Statements
An Information Disclosure Statement (IDS) has not been filed in this application. See MPEP 609 as to requirements for the filing of IDS’s.
Claim Interpretation
Claims are interpreted in accordance with the broadest reasonable interpretation (BRI) standard consistent with the specification (See MPEP 2111).
Claim 1-3 are drawn to a cationic gel and are interpreted as follows:
The term “cationic gel” is interpreted broadly to encompass any topical gel composition exhibiting a net positive charge, and is not limited to particular formulation, or viscosity, as the claims do not recite such limitations.
The term “fungal chitosan” is interpreted as a source-defined form of chitosan and does not impart a functional distinction over chitosan generally, absent additional claim limitations.
The recited silver concentration of “about 1 ppm to about 1,000 ppm” is interpreted to include values within and reasonably close to the stated range, consistent with routine formulation variability.
Claim 4 is drawn to a method of use of the composition and is interpreted as follows:
The term “topically administering” is interpreted to require topical application of the composition to tissue, without requiring proof of a specific therapeutic mechanism or clinical outcome. Under the BRI, any amount of the composition that is topically applied satisfies the administration step.
The term “therapeutically effective quantity” is not defined by the claim, the specification does not provide an objective standard for ascertaining what constitutes an effective quantity. Thus, one of ordinary skill in the art would not be reasonably apprised of the scope of the invention with respect to this limitation and would be unable to ascertain the metes and bounds of the claim as to what constitutes a therapeutically effective quantity.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: “desire size”, “deacetylation”, “alpha-hydroxy acid”, “21”, “22”, “chelated silver” in Figure 1. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 1 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.
With respect to claims 1, the claim recites a “complex” comprising cannabinoids and a chitosan-silver component. The term “complex” is a relative term which renders the claim indefinite. The term “complex” 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 (see MPEP 2173.05). In particular, the specification fails to describe whether the cannabinoid is chelated, bound, or otherwise structurally associated with chitosan-silver. The term "complex" should be interpreted as encompassing a physical association or admixture of components within a single composition. Accordingly, the scope of the term "complex" is unclear and renders the claim indefinite. For purposes of examination, the term "complex" will be interpreted under its broadest reasonable interpretation (BRI) consistent with MPEP §2111.
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.
Claims 1-4 are rejected under 35 U.S.C. §103 as being unpatentable over Wingfield (WO2019/005895 A1, inventor’s previous publication, pub’d 01/03/2019), in view of Jackson et al. (WO2022/016269 A1, hereinafter “Jackson”, pub’d 01/27/2022) and further in view of Gartziandia Lopez de Goikoetxea et al. (WO2022/122471 A1, hereinafter “Gartziandia”, pub’d 06/16/2022).
Wingfield teaches topical wound care compositions which comprise chitosan chelated with silver (page 5, line 34 - page 6, line 6), wherein the silver is present in ppm concentrations (page 6, line 22 - page 7, line 12), thereby forming a cationic antimicrobial composition suitable for application to skin and wound (page 5, line 24 - 27). Wingfield further teaches that the compositions provide antimicrobial activity while maintain suitability for topical administration (page11, line 24 - 27). Thus, Wingfield establishes a known chitosan-silver antimicrobial platform for wound treatment.
However, Wingfield does not teach that (1) the topical cannabinoid compositions, including cannabidiol (CBD) and tetrahydrocannabinol (THC), and (2) the chitosan based topical formulations incorporating cannabinoids for use in skin treatment.
Jackson discloses topical antimicrobial compositions comprising one or more cannabinoids with silver-containing medicament (paragraphs [0026] and [0077]), wherein the cannabinoids are selected for providing antibiotic synergy antibiotic effect (paragraphs [0026] - [0027]), and the forming an antibiotic composition suitable for application to wounds (paragraphs [0077]). Jackson therefore teaches the use of cannabinoids as active agents in silver based topical wound treatment compositions.
Gartziandia discloses chitosan based topical formulations incorporating cannabinoids, including CBD (e.g., a chitosan/hyaluronic acid-based CBD sub-microparticle gel, page 25, Example 11), for use in wound healing applications. Gartziandia teaches that cannabinoids can be effectively incorporated into chitosan ingredients (e.g., chitosan/hyaluronic acid-based particles) for wound dressing. Gartziandia therefore teaches the compatibility of cannabinoids with chitosan based topical compositions.
All three references are directed to the same field of endeavor, namely topical wound and skin treatment, and address related problems of antimicrobial efficacy and wound healing. In accordance with the Supreme Court in KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007), a claimed invention may be found obvious where the prior art teaches each of the claimed elements and a person having ordinary skill in the art (PHOSITA) at the time of the invention would have been motivated to combine those known elements according to their established functions using known methods to achieve predictable results. (see MPEP 2141 and 2143).
It would therefore have been obvious to a PHOSITA at the time of the invention to modify the chitosan-silver wound care composition of Wingfield to further include cannabinoids-silver compositions, as taught by Jackson and to incorporate cannabinoids into a chitosan-based formulation compositions, as taught by Gartziandia. Such a modification would have yielded predictable enhanced antimicrobial activities in topical wound care composition, and would not have required undue experimentation.
With respect to claim 1, the claim recites a cationic gel for wound care comprising a cannabinoid chitosan-silver complex. As discussed above, Wingfield teaches a cationic chitosan-silver wound care composition, and Jackson teaches cannabinoids in silver based topical antimicrobial composition, and Gartziandia teaches incorporation of cannabinoids with chitosan based topical compositions. Accordingly, the combined references teach or suggest all of the limitations of claim 1.
With respect to claim 2, Wingfield teaches and overlapping range of silver at page 6, line 22 – page 7, line 12. Fungal chitosan represents a known source of chitosan, as acknowledged in the specification (paragraphs [05] - [06]), and Jackson further teaches the inclusion of at least one cannabinoid in a silver containing composition.
With respect to claim 3, the claim recites that the at least one cannabinoid is tetrahydrocannabinol (THC) or cannabidiol (CBD). Jackson teaches CBD and THC as antimicrobial and anti-inflammatory cannabinoids suitable for topical wound treatment, and Gartziandia teaches CBD incorporated into in chitosan based topical formulations. The selection of THC or CBD therefore represents an obvious selection from a finite number of identified, predictable options (see MPEP 2144.04).
With respect to claim 4, the claim recites a method for treating a wound or skin disorder by topically administering the composition. Wingfield teaches topical administration of chitosan-silver compositions for wound treatment, and Jackson teaches topical administration of cannabinoids-silver compositions for wounds. Further, Gartziandia teaches topical administration of cannabinoids-chitosan composition for wound applications. Each of the claimed components and their topical use for wound treatment are taught in the prior art. One of ordinary skill in the art would have been motivated to combine these known elements according to their established functions to arrive at the claimed method of topical administration of a composition for treating a wound or skin disorder. Such a combination represents the use of known elements according to known methods to yield no more than predictable results, and therefore the claimed method would have been obvious to one of ordinary skill in the art at the time of the invention in accordance with KSR rationale (A) (see MPEP 2141).
Conclusion
Currently, no claims are allowed and all claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEONG JONG KIM whose telephone number is (571) 270-7679. The examiner can normally be reached on 7:00am-3:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEONG JONG KIM/Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621