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
Status of Claims
The amendments and arguments filed on 02/09/2026 are acknowledged and have been fully considered. Claims 1-8 are now pending. Claims 1-4 are amended; claims 5-8 are withdrawn.
Claims 1-4 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied, and constitute the complete set presently being applied to the instant application.
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 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180049962 A1 (Wang, 2018).
In regards to claim 1, Wang teaches a composition in the form of an aqueous gel for topical/transdermal pharmaceutical products (see paragraphs 0006-0008, 0053-0054). The composition comprises lysine (see paragraph 0130), aloe vera gel (see paragraph 0131), retinol (see paragraphs 0097, 0115), and peptide (see paragraphs 0035, 0058-0059, 0099-0100). The peptide is taught to comprise synthesized peptides as well (see paragraph 0100). The composition is taught to comprise tocopherols (see paragraphs 0051, 0059, 0067-0068) and carnosine (see paragraph 0059).
In regards to claim 4, the composition is taught to comprise ceramides (see paragraphs 0058-0059). As the ceramides are taught as plural, the teaching of Wang is understood to read on the claim language of “a plurality of ceramides”.
Wang 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 Wang 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 composition of the instant claims with predictable results.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over US PGPUB 20180049962 A1 (Wang, 2018) as applied to claims 1 and 4 above, and further in view of Schagen (2017).
The teachings of Wang have been described supra.
The teachings of Wang are silent on the use of palmitoyl tripeptide-5 and tripeptide-10 citrulline.
Schagen teaches that topical cosmeceutical peptides have many uses and are able to traverse the skin barrier (see Schagen, introduction, paragraphs 2-5). Specifically it is taught that tripeptide-10 citrulline is used to increase skin suppleness from better collagen fiber cohesion (see Schagen, 2.3. tripeptide-10 citrulline) and that palmitoyl tripeptide-3/5 (AKA palmitoyl tripeptide-5) increases collagen synthesis and has been shown to have anti-wrinkle efficacy (see Schagen, 2.5. Tripeptide 3/5).
In regards to claims 2-3, 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 formulate a composition comprising either palmitoyl tripeptide-5 or tripeptide-10 citrulline as the peptide in the composition of Wang. As Wang teaches the use of a synthetic peptide in the composition and Schagen teaches that these specific synthetic peptides have known benefits in a transdermal application, it would be within the purview of one with ordinary skill in the art to use these peptides in the composition of Wang. One with ordinary skill in the art would be motivated to combine the peptides of Schagen with the composition of Wang according to the method of making a cosmetic composition (see Wang, paragraphs 0291-0293). It would be obvious to one with ordinary skill in the art to combine prior art elements according to known methods to yield predictable results with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 02/09/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
In regards to applicant’s arguments that the teachings of Wang disclose a large number of combinations and does not teach the combination of the specific compounds of the instant application together. Applicant also argues that the composition of the instant claims displays synergy when using the compounds together. First, it is pointed out that the claims do not indicate any sense of synergy either, only the presence of the compounds, which is taught in either Wang or Wang in combination with Schagen together.
Applicant argues that the art teaches the various compounds as optional and spanning dozens of categories in long lists without motivation to combine them specifically, however it is pointed out that Wang teaches a skin protection composition from UV light (see paragraph 0005-0006) (i.e., a skin cosmetic) and as such, compounds like aloe vera (i.e., a humectant, moisturizer, and skin conditioner (see paragraph 0131)), retinol or tocopherols (i.e., skin care actives (see paragraph 0051), lysine (i.e., an antioxidant (see paragraph 0130), carnosine, and peptides (see paragraph 0058-0059) are known to be used in cosmetic compositions (see paragraph 0058). These are widely known in the art and it would not be difficult for a person of ordinary skill in the art to envisage their usage together.
Applicant also argues that the compounds used together have synergy, which would be an unexpected result. Applicant is reminded that whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). In the instant case, there are no working examples described to help show the synergy alleged. Only statements in the specification, which are not present in the claims. As written now, the claims are drawn to a composition comprising specific ingredients, which are taught in the prior art to be known to be used together. It is not clear in what conditions or amounts the synergistic effects become apparent (e.g., would 1% of any type of tocopherol combined with a 99% mixture of the other ingredients have the synergistic capabilities that are discussed?). Without this data, it is not possible to establish unexpected results and as such, the claims remain rejected over the prior art. "[A]ppellants have the burden of explaining the data in any declaration they proffer as evidence of non-obviousness." Ex parte Ishizaka, 24 USPQ2d 1621, 1624 (Bd. Pat. App. & Inter. 1992). Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971) for examples of cases where indirect comparative testing was found sufficient to rebut a prima facie case of obviousness.
Double Patenting
The terminal disclaimer filed 02/09/2026 is sufficient in overcoming the previous provisional double patenting rejections.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.A.A./Examiner, Art Unit 1611
/ISIS A GHALI/Primary Examiner, Art Unit 1611