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 . Claims included in prosecution are claims 1-3 and 6-20.
Previous Rejections
Applicants' arguments, filed 3/24/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103 (Maintained)
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.
1. Claims 1-3, 6-9, and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (CN 107365355, Nov. 21, 2017) (hereinafter Luo).
Luo teaches peptides having anti-wrinkle effects and their use in cosmetic and personal care compositions (Technical Field). The composition comprises (a) a peptide or peptide combination; (b) an antioxidant; (c) a humectant; (d) vegetable oil; (e) lecithin; (f) a preservative; (g) essential oil; and (h) Purified water (Summary of the Invention, Par. 10). The composition may comprise cosmetically acceptable carriers which may be hydrophobic or hydrophilic (satisfies carrier of claim 1) (Summary of the Invention, Par. 14). Suitable carriers may be wax-like (i.e., solid) or in solution form (i.e., liquid) (satisfies claim 11-12) (Summary of the Invention, Par. 15-16). The composition may formulated into forms known in the art (Summary of the Invention, Par. 17). Preferred humectants include sodium pyrrolidone carboxylate which is included in a preferred amount of 0.1 to 30 wt.% (satisfies pyrrolidone carboxylate of claim 1 & 8-9) (Summary of the Invention, Par. 21). Suitable vegetable oils include linseed oil (i.e., flaxseed oil) which is included in a preferred amount of 0.5 to 8 wt.% (satisfies plant oil of claim 1 & 6-7) (Summary of the Invention, Par. 22). In Example 2, all the components are added and uniformly stirred (satisfies claim 13).
The prior art is not anticipatory insofar as this combination must be selected from different lists/locations in the reference. It would have been obvious, however, to have made a personal care composition consisting essentially of a carrier, a plant oil, and a salt of pyrrolidone carboxylate, as instantly claimed, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP § 2143 (I)(A).
Regarding the recitation of “consisting essentially of” present in claim 1, neither the instant claim nor the instant specification provide guidance as to what components would materially affect the instant composition. As such, absent clear indication as to what would materially affect the instant composition, it would be reasonable for one of ordinary skill in the art to conclude that the composition of Luo satisfies the limitations of the instant claim.
Regarding the amounts of plant oils and salts of pyrrolidone carboxylate recited in instant claim 1, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(I). As discussed above, Luo’s composition comprises humectants such as sodium pyrrolidone carboxylate in an amount of and 0.1 to 30 wt.% and vegetable oils such as linseed oil in an amount of 0.5 to 8 wt.%. Accordingly, because the amounts recited in the instant claims overlap with the ranges disclosed by Luo, the ranges disclosed by Luo meet the instantly recited limitations and would be effective amounts to increase NMFs and AMPs as instantly claimed.
Regarding the ratio of plant oils to salts of pyrrolidone carboxylate recited in instant claim 1 (i.e., about 5:1), in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05(A). As discussed above, Luo composition comprises sodium pyrrolidone carboxylate in an amount of and 0.1 to 30 wt.% and linseed oil in an amount of 0.5 to 8 wt.%. Accordingly, the claimed weight ratio would have been obvious from one of ordinary skill in the art selecting an amount of sodium pyrrolidone carboxylate and an amount of linseed oil from the above ranges and the ratio thereof overlapping with the claimed ratio.
In regards to instant claims 14-20, the instant specification discloses in Examples 2 and 3 wherein the combination of sodium PCA and flaxseed oil exhibited an increase of antimicrobial peptide biomarker LL-37 and an increase NMF, Caspace-14. Accordingly, since Luo discloses a composition comprising sodium PCA and flaxseed oil in amounts that overlap with those of the instant claims, the composition of Luo necessarily exhibits the same properties as the claimed invention. As such, it would have been obvious to have used the composition of Luo in methods for treating microbes on skin and treating dry skin as instantly claimed.
2. Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Luo et al. (CN 107365355, Nov. 21, 2017) (hereinafter Luo) in view of Gautier et al. (US 2010/0003292, Jan. 7, 2010) (hereinafter Gautier).
The teachings of Luo are discussed above.
Luo differs from the instant claims insofar as not disclosing wherein the composition is in the form of a shower gel or a bar soap. However, Gautier teaches a cosmetic composition for face or body care which has an anti-aging effect, including an anti-wrinkle effect (Abstract). The composition is preferably in topical form and may contain plant oils (¶ [0094]). The composition may be formulated into a shower gel or a dermatological cleansing bar (i.e., bar soap) (¶ [0097]).
Accordingly, it would have been obvious for one of ordinary skill in the art to have formulated the composition of Luo to be in the form of a shower gel or a bar soap since Luo does not limit the form of the composition and since these are known forms of anti-wrinkle compositions that comprise plant oils as taught by Gautier.
Response to Arguments
Applicant’s arguments filed 3/24/26 have been fully considered but they are not persuasive.
Regarding Applicant’s argument that the prior Office Action made an assertion of “no data supporting the alleged unexpected results”, the Examiner submits that in Applicant’s previously filed remarks, dated 10/7/25, Applicant pointed to Paragraph 26 as evidence of synergistic/unexpected results in Section B. titled “The Claimed Composition Exhibits Unexpected Results”. Said section made no reference to another portion of the specification where the Examiner may look to as evidence of unexpected results. In response, the Examiner noted that “while the paragraph of the specification that Applicant pointed to (i.e., Par. 26) does state that the present inventors have found that a composition containing a carrier, one or more plant oils, and one or more salts of pyrrolidone carboxylate increase the amount of AMP production and NMFs in the skin, said paragraph makes no mention of a synergistic relationship between said components and does not recite any amounts or ratios that would impact this alleged finding. Furthermore, said paragraph and Applicant’s arguments provide no data supporting the alleged unexpected results nor any data suggesting that any effect that a carrier, plant oils, and salts of pyrrolidone carboxylate would have is synergistic and not additive. The paragraph that Applicant points to merely states that compositions including a carrier, one or more plant oils, and one or more salts of pyrrolidone carboxylate have the alleged unexpected result of increasing the amount of AMP production and NMFs in the skin”. As such, the Examiner’s response related specifically to the paragraph that Applicant pointed to and does not simply state that there is “no data supporting the alleged unexpected results”.
Regarding allegations of unexpected results, any differences between the claimed invention and the prior art may be expected to result in some difference in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. The burden is on applicant to establish that the results are in fact really unexpected and of statistical and practical significance. Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992). See also MPEP § 716.02. Applicant does not appear to have discussed same with respect to objective data. For instance, it is unclear if the test cleansing compositions contained additional components that might have affected the production of LL-37 and Caspase-14. For example, it is unknown if compositions #2-#3 contained components that inhibited the production of LL-37 as compared to composition #4. As such, one of ordinary skill in the art would not be able to properly ascertain how the comparative composition actually compares to the inventive examples of the instant specification.
Finally, assuming, purely arguendo, that unexpected results have been established, the probative value of the evidence as compared to the invention as claimed must then be determined, i.e., the claims must be “commensurate in scope” with the showing. MPEP § 716.02(d). See also MPEP § 2145. Applicant must explain the “manner in which the specific compositions illustrated are considered to be commensurate in scope with the claimed invention”; see Ex parte Gelles, 22 USPQ2d 1318 (Bd. Pat. App. & Inter. 1992); see also MPEP 716.02 and 716.02(b) I-II.
For instance, Applicant’s claim 1 requires the presence of any one or more of plant oils. However, the examples tested only contained flaxseed oil. As such, it is unclear if only using the oil tested (i.e., flaxseed oil) would result in the alleged unexpected results or if using all plant oils encompassed by the instant claims would as well. Further, it is not clear if the results would vary if other plant oils were used in place of the one tested. In order for this to be established, the tested plant oil (i.e., flaxseed oil) must be reasonably representative of plant oils in general. However, no evidence of this has been provided. As such, the probative value of the data cannot be reasonably extended across the full breadth of the claimed components since a trend cannot be reasonably determined. Furthermore, Applicant’s claim 1 requires the presence of any one or more salts of pyrrolidone carboxylate. However, the examples tested only contained sodium pyrrolidone carboxylate. As such, it is unclear if only using the tested sodium pyrrolidone carboxylate would result in the alleged unexpected results or if using all salts of pyrrolidone carboxylate encompassed by the instant claims would as well. Further, it is not clear if the results would vary if other salts of pyrrolidone carboxylate were used in place of the one tested. In order for this to be established, the tested salt of pyrrolidone carboxylate (i.e., sodium pyrrolidone carboxylate) must be reasonably representative of salts of pyrrolidone carboxylate in general. However, no evidence of this has been provided. As such, the probative value of the data cannot be reasonably extended across the full breadth of the claimed components since a trend cannot be reasonably determined. Accordingly, Applicant’s data is not commensurate in scope with the instant claims.
Regarding Applicant’s arguments that the Examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). As discussed above, where Luo discloses the use of a carrier, sodium pyrrolidone carboxylate, and linseed oil in a composition in amounts/ratios that overlap with those of the instant claims, it would have been obvious for one of ordinary skill in the art to have used those components to have formulated a composition containing those components. Accordingly, no improper hindsight was used in the conclusion of obviousness in the rejection of record.
Regarding Applicant’s argument that Luo teaches a complex composition while the claimed invention is a simple composition and that Luo discloses several alternatives to the claimed components, the Examiner submits that a reference is relied upon for all it teaches and suggests, even non-preferred embodiments. See MPEP § 2141.02 (VI). Where Luo suggests the use of a carrier, sodium pyrrolidone carboxylate, and linseed oil in a composition in amounts/ratios that overlap with those of the instant claims, it would have been obvious for one of ordinary skill in the art to have used those components to have formulated a composition containing those components. The Examiner points to the fact that water (i.e., a carrier), humectant, and vegetable oil are required by Luo as disclosed at Par. 10 - Summary of the Invention. Furthermore, Luo discloses that sodium pyrrolidone carboxylate is a preferred humectant. A such, in view of the Luo disclosure one of ordinary skill in the art would have had enough motivation to utilize these components in a composition as instantly claimed.
Regarding Applicant’s argument that Gautier fails to rectify the alleged deficiencies of Luo, the Examiner submits that Gautier cures any alleged deficiencies of Luo where Gautier discloses that a shower gel or a bar soap are known forms of anti-wrinkle compositions that comprise plant oils.
In light of the foregoing, the Examiner does not find Applicant’s arguments to be persuasive and the rejections are maintained.
Double Patenting (Maintained)
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
1. Claims 1-3 and 6-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of U.S. Patent No. 12,097,280 in view of Klofta et al. (US 2011/0264059, Oct. 27, 2011) (hereinafter Klofta).
The patented claims recite a personal care composition comprising a carrier and one or more plant oils. The patented claims differ from the copending claims insofar as reciting wherein the composition contains one or more salts of pyrrolidone carboxylate. However, Klofta teaches that sodium pyrrolidone carboxylate (i.e., a pyrrolidone carboxylate salt) is effective in replacing lost skin NMFs and preventing the loss of more NMFs and moisturizing the skin (¶ [0040]).
Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sodium pyrrolidone carboxylate into the claimed invention motivated by the desire to achieve the skin moisturizing effects taught by Klofta.
Response to Arguments
Applicant’s arguments are the same as above.
The Examiner’s response above is repeated as above. Furthermore, Applicant has not submitted documentation (i.e. terminal disclaimer) in response to the double patenting rejection(s).
Therefore, the previous rejections of non-statutory double patenting are maintained.
Conclusion
Claims 1-3 and 6-20 are rejected.
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Abdulrahman Abbas whose telephone number is (571)270-0878. The examiner can normally be reached M-F: 8:30 - 5:30.
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/A.A./Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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