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
Applicant’s response filed on September 19, 2025 to the Final rejection mailed on July 16, 2025 is acknowledged.
The claims corresponding to the elected subject matter are 1, 8-14 are herein acted on the merits. Claim 15-16 is withdrawn.
Information Disclosure Statement
No new information disclosure statement(s) (IDS) filed.
Response to Arguments
Applicant’s arguments over the 35 U.S.C. 103 rejection of claims 1, 8-14 over Masamichi et al. ( JP2009046472A) in view of Wiechers (Formulating at pH 4-5: How Lower pH Benefits the Skin and Formulations. Oct 28th, 2013) is not persuasive. The rejection is herewith maintained. Applicant argues, Masamichi et al. does not disclose the use of two or more of polyhydric alcohol fatty acid ester-type nonionic surfactants. Applicant points to Table I and states the combination of the two or more polyhydric alcohol fatty acid ester-type nonionic surfactants provides an unexpected improvement in a number of properties.
The Examiner’s contention is that ''[I]t is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980.) Moreover, the Examiner points out that while the Applicant argues unexpected improvement in a number of properties, the Examples compare a very specific formulation (components and amounts), while the claims are broad to many different components encompassed by i.e. A, B, C, and D. The arguments do not commensurate in scope with the claims. Furthermore, the Examiner suggests quantifying what the evaluation in Table I corresponds to in terms of unexpected results. For example, what does a letter ‘E’ mean under the evaluation? The arguments are not persuasive.
The rejections are as below:
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.
Claims 1, 8-14 are rejected under 35 U.S.C. 103(a) as being unpatentable over Masamichi et al. ( JP2009046472A) in view of Wiechers (Formulating at pH 4-5: How Lower pH Benefits the Skin and Formulations. Oct 28th, 2013)
Masamichi et al. teaches an emulsified composition comprising prednisolone acetate valerate, higher alcohols such as cetanol, stearyl alcohol, etc, lecithin preferably 5 to 30% by weight used include soybean lecithin, egg yolk lecithin, purified soybean lecithin, purified egg yolk lecithin, hydrogenated soybean lecithin, egg yolk lysophosphatidylcholine, soybean lysophospholipid and the like; surfactants other than the lecithin include polyoxyethylene monostearate (20) sorbitan (polysorbate 60); moisturizers including extracts from plants such as ceramides. The emulsified composition of the present invention may further contain water. The formulation has an inhibitory effect on Staphylococcus aureus adhesion and an excellent moisturizing effect. It has been found that the emulsified composition is useful for treating, preventing or ameliorating symptoms caused by skin dryness and / or diseases (especially atopic dermatitis etc.) showing symptoms caused by dry skin.
While the reference does not exemplify a formulation comprising the specific stearyl alcohol, hydrogenated soybean lecithin, polyoxyethylene monostearate (20) sorbitan, ceramides and water, the reference does teach each component at a pH as claimed.
Wiechers teaches formulations for topical application with a pH between 4-5, or 5.5.
It would have been obvious to one of ordinary skill in the art at the time of filing to incorporate a stearyl alcohol, hydrogenated soybean lecithin, polyoxyethylene monostearate (20) sorbitan, ceramides and water at a pH of 4-5. The motivation to incorporate stearyl alcohol, hydrogenated soybean lecithin, polyoxyethylene monostearate (20) sorbitan, ceramides and water comes from the teaching in Masamichi et al. that stearyl alcohol acts as a base, hydrogenated soybean lecithin and polyoxyethylene monostearate (20) sorbitan as surfactants, and ceramides as moisturizers and Wiechers teaching of the importance of this acidic pH for normal skin homeostasis. Hence, a skilled artisan would have had reasonable expectation of success in achieving similar efficacy and results. Additionally, since the general conditions of the claim are taught in the prior art, discovering optimum or workable mass% ranges and ratios involves only routine skill in the art (In re Aller).
Conclusions
No claims are allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 mailing date of this final action.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAYLA SOROUSH whose telephone number is (571)272-5008. The examiner can normally be reached on Monday thru Friday; 8:30 AM to 5:00 PM PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, James Henry Alstrum-Acevedo, can be reached on (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622