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
The Applicant’s reply filed on 7/10/26 is acknowledged. Claims 1, 6, 7, 10, 12, 13, 15, 18, 21-25, 28, 30, and 62-66 are pending. Claims 63-66 are new. Claims 10, 23, 25, 28 and 30 have been withdrawn. Claims 1, 6, 7, 18, and 24 have been amended.
Claims 1, 6, 7, 12, 13, 15, 18, 21, 22, 24 and 62-66 are under consideration to the extent that composition comprises the elected species of a) squalene and b) presence of palmitic acid.
Objections Withdrawn
The objections of claims 3, 6, 7, 13, 18, 20 and 24 are withdrawn in view of the amended claims.
Rejections Withdrawn
The rejection of Claim 4 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn in view of the canceled claims.
The rejection of Claims 1, 3-6, 13, 20-22 and 62 under 35 U.S.C. 103 as being unpatentable over Okubo et al. (US 2005/0163742; cited previously) is withdrawn in view of the amended claims.
The rejection of Claims 7, 12 and 24 under 35 U.S.C. 103 as being unpatentable over Okubo et al. (US 2005/0163742; cited previously) as applied to claims 1, 3-6, 13, 20-22 and 62 above, and further in view of Bouwstra et al. (US 2011/0165203) is withdrawn in view of the amended claims.
The rejection of Claims 15 and 18 under 35 U.S.C. 103 as being unpatentable over Okubo et al. (US 2005/0163742; cited previously) as applied to claims 1, 3-6, 13, 20-22 and 62 above, and further in view of Seppic (Simulgel EG <https://www.ulprospector.com/en/na/ PersonalCare/Detail/1432/46887/SIMULGEL-EG> 2015) is withdrawn in view of the amended claims.
Rejections Maintained and New Grounds of Rejections
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 8/10/26. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6 and 7 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 recites that the composition of claim 1 further comprises about 7% by weight to about 12% by weight glycerin, however, claim 1 has been amended to recite from about 8% by weight to about 12% by weight glycerin. Therefore, claim 6 does not further limit claim 1.
Claim 7 recites that the composition of claim 1 further comprises one or more conditioning agents, including at least one of 1,3 butanediol, isohexadecane, or squalene, however, claim 1 has been amended to recite the inclusion of 22% by weight to about 28% by weight 1,3-butanediol. Therefore, claim 7 does not further limit claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 63 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over Okubo et al. (US 2005/0163742; cited previously).
Okubo et al. teach a water-in-oil emulsified composition containing a sphingosine, a C6-30 fatty acid, and an oil component (e.g. abstract). Example 8 is an emulsion comprising 1.0 wt% sphingosine, 1.5 wt% palmitic acid, and water (e.g. Table 2). Example 3 is an emulsion comprising 0.25 wt% palmitic acid and 62.55 wt% water. Okubo et al. more broadly teach water in amounts of 1-80 wt%, palmitic acid in amounts of 0.001 to 10 wt%, and sphingosine in amounts of 0.001 to 10 wt%, which overlap the claimed ranges (e.g. paragraphs 0035, 0040 and 0066). Okubo et al. further teach the inclusion of a humectant comprising 1,3-butylene glycol, propylene glycol, and/or glycerin (i.e. one or more diols having 3-6 carbon atoms) (e.g. paragraph 0067), but do not teach a general concentration thereof. Okubo exemplify 20 wt% humectants in Examples 1, 2, 4 and 5, which overlaps with the claimed range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding the limitation, “wherein the formulation increases the amount of ceramide present on the skin of the subjects by at least 5% greater than a baseline amount of the ceramide present on the skin of the subject”, Okubo is silent. However, as Okubo teaches applying compositions to the skin of a user comprising the claimed ingredients in the claimed amounts, then the outcome of increasing the amount of ceramide present on the skin of the subjects by at least 5% greater than a baseline amount of the ceramide present on the skin of the subject would necessarily occur.
Regarding Claim 63, it would have been obvious to one of ordinary skill in the art at the time of filing to vary the concentrations of the water, palmitic acid, and sphingosine of Okubo et al. It would have been obvious to one of ordinary skill in the art at the time of the instant invention to vary the concentrations through routine experimentation to arrive at the claimed concentrations in order to optimize the resulting product. It is obvious to optimize within prior art conditions or through routine experimentation. In addition, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (MPEP 2144.05.I).
Regarding Claim 64, Okubo et al. further the inclusion of a humectant comprising 1,3-butylene glycol, propylene glycol, and/or glycerin (e.g. paragraph 0067), but do not teach a general concentration thereof. Okubo exemplify 20 wt% humectants in Examples 1, 2, 4 and 5, which is adjacent to the lower combined range of claim 64 of 22 wt%. It would have been obvious to one of ordinary skill in the art at the time of filing to vary the concentrations of the individual humectants through routine experimentation to arrive at the claimed concentrations in order to optimize the resulting product. It is obvious to optimize within prior art conditions or through routine experimentation. In addition, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. In the instant case, 20% humectant and 22% are expected to have the same skin moisturizing qualities.
Allowable Subject Matter
Claims 1, 12, 13, 15, 18, 21, 22, 24, 62 and 66 are allowed.
Claim 65 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 7/10/26 have been fully considered but they are not persuasive. Arguments relevant to the current grounds of rejection will be addressed below.
Applicant argues that Okubo does not teach or suggest a formulation that "increases the amount of ceramide present on the skin of the subjects by at least 5% greater than a baseline amount of the ceramide present on the skin of the subject," as recited in claim 63.
This is not found persuasive. As Okubo teaches applying compositions to the skin of a user comprising the claimed ingredients in the claimed amounts, then the outcome of increasing the amount of ceramide present on the skin of the subjects by at least 5% greater than a baseline amount of the ceramide present on the skin of the subject would necessarily occur. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Blanchard can be reached on 571-272-0827. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
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