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 .
Acknowledgement of Receipt
Applicant's response filed on 08/12/2025 to the Office Action mailed on 06/04/2025 is acknowledged.
Claim Status
Claims 1-2 and 4-12 are pending.
Claims 1 and 5 are currently amended.
Claim 3 is canceled.
Claims 1-2 and 4-12 have been examined.
Claims 1-2 and 4-12 rejected.
New (Modified) Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This rejection is modified from the previous Office Action in view of the amendments to the claims.
Claims 1-2 and 4-12 are rejected under 35 U.S.C. 103 as being unpatentable over Doxey et al., (US 2016/0256484 A1, Sept. 8, 2016) (hereinafter Doxey).
Doxey discloses an admixture suitable for topical administration, which may comprise a single phase or comprise a hydrophobic composition and a hydrophilic composition ([0055]). The hydrophilic composition in the form of a hydrogel (i.e., an aqueous gel) comprises water (i.e., an aqueous phase) ([0056]). A polymer, such as, carboxymethyl cellulose (i.e., a hydrophilic gelling agent), may be present in a hydrophilic composition in an amount of about 0.1% to about 15% by weight of the hydrophilic composition ([0065]). A hydrophilic composition may comprise a preservative present in an amount of about 0.01% to about 2% by weight of the hydrophilic composition ([0068]). Preservatives include sodium propionate (i.e., short-chain fatty acid salt, comprising a saturated or unsaturated and straight or branched aliphatic chain containing 3 to 8 carbon atoms) and glycerin ([0069]). The composition may be used in a method to treat a subject having a cosmetic condition, such as a scar or crow's feet ([0131]). A composition of the present invention may be applied topically to any portion of a subject's skin (i.e., keratin material) ([0132]). An admixture of the present invention may further comprise a humectant (i.e., at least one additional cosmetic active agent) ([0102]). In Table 9, formulation PHO-004 has a pH of 7 and 100% (i.e., at least 90%) of an aqueous phase, including carboxymethylcellulose sodium in 3.5% by weight of the aqueous phase ([0152]). Potassium phosphate monobasic and potassium phosphate dibasic are components of the hydrophilic composition (i.e., aqueous phase), as noted in paragraph [0059] and as discussed above, glycerin is also found in the hydrophilic composition (i.e., aqueous phase).
The prior art discloses compositions containing sodium propionate (i.e., short-chain fatty acid salt, comprising a saturated or unsaturated and straight or branched aliphatic chain containing 3 to 8 carbon atoms) ([0069]), carboxymethyl cellulose (i.e., a hydrophilic gelling agent) ([0065]), in a hydrophilic composition (i.e., an aqueous phase) ([0056]). Together these would provide a composition as claimed instantly. The prior art is not anticipatory insofar as these combinations must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination 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 claimed weight of short-chain fatty acid salt with respect to the total weight of the composition between 1% and 4%, as recited in claim 1 and between 1% and 3%, as recited in claim 4, as discussed above, Doxey teaches that sodium propionate present in an amount of about 0.01% to about 2% by weight of the hydrophilic composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Response to Applicant’s Arguments
The rejection of claims 1-12 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn in view of amendments to the claims.
With regard to the rejection of claims 1-2 and 4-12 under 35 U.S.C. 103 as being unpatentable over Doxey et al., (US 2016/0256484 A1, Sept. 8, 2016) (hereinafter Doxey):
Applicant argues that the pending claims and invention are directed to cosmetic solutions capable of stimulating sebum production by aged skin and comprising at least one short-chain fatty acid salt, which is different from the technical problem solved by Doxey, as Doxey does not relate to cosmetic compositions, and even less to the specific technical problem that is solved according to the invention. Applicant’s argument has been fully considered but found not to be persuasive. Doxey teaches that the composition is applied to the skin of a subject ([0125]) having a cosmetic condition, such as a scar, crow's feet, etc. ([0131]). Accordingly, Doxey teaches a cosmetic composition. Further, the claims as recited do not require cosmetic solutions capable of stimulating sebum production by aged skin.
Applicant argues that Doxey does not teach the specifically high concentration of a short chain fatty acid salt such as a propionate required by the present invention. Applicant’s argument has been fully considered but found not to be persuasive. Doxey teaches sodium propionate present in an amount of about 0.01% to about 2% by weight of the hydrophilic composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A.
Applicant argues that Doxey teaches the use of sodium propionate as a preservative which is different than the instant application which includes sodium propionate as an active ingredient to improve lipid synthesis or stimulate sebum production in skin, which is a non-obvious use of a known compound. Applicant’s argument has been fully considered but found not to be persuasive. Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979). See MPEP 2145. Further, the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). Doxey teaches that the composition may comprise a preservative and preservatives include sodium propionate. Accordingly, it would have been obvious to formulate the composition of Doxey to comprise sodium propionate.
Applicant argues that Doxey discloses a range of 0.01% to 2% by weight for preservatives, and the range is applied generically to the entire list of preservatives but no disclosure, preference, or example indicates that sodium propionate, or any SCFA salt, would be used at or above 1% by weight in such compositions. Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above. Doxey teaches sodium propionate present in an amount of about 0.01% to about 2% by weight of the composition. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. MPEP 2144.05 A. Further, a rejection made under 103 does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123.
Applicant argues that those skilled in the art understand that the effective concentration of preservatives is limited by safety, irritation potential, odor, and formulation stability and SCFA salts, such as sodium propionate, are known to be difficult to formulate in higher concentrations due to their volatility, odor, and potential irritation. These constraints would teach away from their use at levels as high as 3% to 4% by weight in a topical cosmetic formulation, rendering the claimed range a non-obvious selection. Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above regarding the claimed range of sodium propionate, which is between 1% - 4%. Further, “The arguments of counsel cannot take the place of evidence in the record.” In re Schulze, 346 F.2d 600, 145 USPQ 716, 718 (CCPA 1965), In re Huang, 40 USPQ 2d 1685 (Fed. Cir. 1996), In re De Blauwe et al., 222 USPQ 191, (Fed. Cir. 1984). Applicant has not provided any factual evidence establishing unobviousness. MPEP 716.01(c).
Applicant argues that the disclosure of Doxey is non-enabling and would not lead a person of ordinary skill in the art to reasonably expect success in using SCFA salts from 1% to 4% by weight to achieve the cosmetic effects claimed because Doxey generically lists sodium propionate among dozens of unrelated preservatives and does not provide any experimental data, rationale, or preference for using sodium propionate, in any concentration, let alone at higher levels. Nor does it differentiate preservatives by structure, function, or formulation challenges. Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above, including, a rejection made under 103 does not need to exemplify all embodiments, only suggest. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123.
Applicant argues that experimental data included in the application as field demonstrates that stable gel formulations containing from 2 % to 3 % sodium propionate by weight with different hydrophilic gelling agents as claimed can be produced, citing examples 1 to 9 of the application as filed, and that a person of ordinary skill in the art would not reasonably expect that a composition with >2 % by weight of a SCFA salt such as sodium propionate could be stabilized for cosmetic application without extensive formulation problems. Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above. Further, 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). The claimed weight includes amounts above and below 2 % to 3 %. The claimed weight of short-chain fatty acid salt with respect to the total weight of the composition is between 1% and 4%, as recited in claim 1 and between 1% and 3%, as recited in claim 4. Thus, the claimed weight of short-chain fatty acid salt is not commensurate in scope with the cited examples.
For the foregoing reasons the rejection is modified and maintained.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Samantha J Knight whose telephone number is (571)270-3760. The examiner can normally be reached Monday - Friday 8:30 am to 5:00 pm ET.
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/S.J.K./ Examiner, Art Unit 1614
/ALI SOROUSH/ Supervisory Patent Examiner, Art Unit 1614