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
Applicant’s response to restriction requirement filed 05/06/2026 is acknowledged. Upon further search and consideration, art was located that teaches the entire claimed invention and as such the restriction/election is withdrawn and all claims are examined herein.
Priority
Provisional application filed 03/23/2023 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/11/2023 is acknowledged. All references have been considered unless marked with a strikethrough. The information disclosure statement filed 12/11/223 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
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, 3-4, 6-10, 12, and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Kerr (US 20180168979 A1).
Regarding claims 1 and 9, Kerr teaches an anti-dandruff composition for the scalp that contains zinc pyrithione and piroctone olamine (para. [0002]). Kerr teaches that many other components can be incorporated into the composition such as vitamin C as ascorbic acid and its derivatives (i.e. L-ascorbic acid, (para. [0112]). Kerr further describes that the anti-dandruff actives (i.e. L-ascorbic acid and anti-fungal agents) can be diluted by an excipient, which acts as a vehicle for the active ingredients (para. [0087]).
Regarding claims 3-4, 10, and 12, Kerr teaches the presence of ketoconazole, salicylic acid, selenium sulfide, and coal tar to function as anti-fungal agents in the composition (para. [0002]).
Regarding claims 6-8 and 14-16, Kerr describes that the concentration of the zinc pyrithione can range from 0.1-0.3 wt.% (para. [0070]), the concentration of piroctone olamine can be 0.1-1 wt.%, and the concentration of salicylic acid can be 0.4-5 wt.% (para. [0070]). The ranges of concentrations disclosed in instant claims 6-8 and 14-16 are fully encompassed by the ranges taught in Kerr, and as such are obvious. See MPEP § 2144.05(I).
Kerr does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Kerr with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen 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. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results.
Claim(s) 2, 5, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Kerr (US 10898421 B2) in view of Duffy (US 6020367 A).
While Kerr teaches the claimed invention as above, it fails to teach a composition where the ascorbic acid is incorporated into a liposome.
Regarding claims 2 and 11, Duffy discloses a method of preparing a saturated and stable solution of ascorbic acid, where the ascorbic acid is encapsulated in a vesicle (see claim 1). Duffy further teaches that the ascorbic acid is L-ascorbic acid (see claim 2), and it is encapsulated within a liposomal vesicle (see claim 8).
Kerr and Duffy are considered to be analogous to the claimed invention because they are both in the field of compositions for topical application. The person of ordinary skill in the art would be motivated to incorporate the L-ascorbic acid into a liposomal vesicle because Duffy teaches the challenges with the formation of a delivery system for L-ascorbic acid, since it is stable only in the solid form and at ambient temperatures (col. 2, line 16). Preparing the L-ascorbic acid to be within a liposome improves its stability in a composition. The skilled artisan would have been motivated to incorporate the liposome encapsulated L-ascorbic acid taught in Duffy with the anti-dandruff composition taught in Kerr, for the benefit of improved stability of the L-ascorbic acid. MPEP § 2143(I)(g).
Regarding claims 5 and 13, Duffy teaches that the concentration of the ascorbic acid in the solution is 0.15-25 wt.% (col. 5, line 57). The concentration in instant claims 5 and 13 overlap with the concentration taught in Duffy, and as such are obvious. MPEP § 2144.05(I).
Conclusion
Claims 1-16 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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