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 8/13/26 is acknowledged. Claims 18-20 and 22-32 are pending. Claims 18 and 22-24 have been amended. Claim 32 is new. Claims 18-20 and 22-32 are under consideration.
Objections Withdrawn
The objection to the Specification is withdrawn in view of the amended abstract.
Rejections Maintained and New Grounds of Rejections
Information Disclosure Statement
Acknowledgement is made of Applicant’s information disclosure statements (IDS) submitted on 8/13/26. The submissions are 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-20 and 22-32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 18 includes matter not present in the original claims or Specification.
Claim 18 recites a “non-aqueous” composition consisting of compound (a), stearamidopropyl dimethylamine, and one or more alcohols. However, “alcohols” are recited only as an additional diluent, present in small amounts, and to be combined with water. The Specification recites, “[w]ater is the preferred diluent. The formulations typically contains greater than one percent (wt) water, preferably greater than five percent (wt) water, more preferably greater than 50% (wt) water, and most preferably greater than 80% (wt) water. Alcohols, such as ethyl alcohol and isopropyl alcohol, may be used at low concentrations (about 0.5% by weight of the formulation) to enhance hair or skin penetration and/or reduce odor” (e.g. paragraph 0102) and when in the form of a spray “[i]n some embodiments, the carrier is water or a water and alcohol mixture (e.g. paragraph 0106). There is not support for a composition where the sole carrier or diluent is one or more alcohols. Claims 19, 20, and 22-32 are rejected as depending from and including the new matter of claim 18.
Response to Arguments
Applicant's arguments filed 8/13/26 have been fully considered but they are not persuasive. Applicant argues that the Specification provides support for alcohols as a diluent and as emulsifiers (paragraph [0096]), preservatives (paragraph [0098]), surfactants (paragraph [0090]), opacifying agents (paragraph [0105]), and cosmetically acceptable carriers (paragraph [0106]). Thus, the claim can include alcohol(s) without also requiring water.
This is not found persuasive. The paragraphs referred to by Applicant contain specific species of alcohol and do not provide support for the genus of “alcohols”. For example, [0096] includes emulsifiers including “cetearyl alcohol” and “glycol”, but this does not provide support for the entire genus of alcohols. The general term “alcohols” is recited only in [0102] and [0106] which explicitly state, “Alcohols, such as ethyl alcohol and isopropyl alcohol, may be used at low concentrations (about 0.5% by weight of the formulation) to enhance hair or skin penetration and/or reduce odor” and “In some embodiments, the carrier is water or a water and alcohol mixture”. There is no support for the genus of alcohols as the only diluent or in a non-aqueous composition (i.e. consisting of). In addition, [0106] is limited to sprays, which is not required by claim 18.
It is further noted that claim 27 and [0048] allow for up to 50 wt% of the compound(s), claim 28 and [0102] allows for up to 0.5 wt% of the one or more alcohols, and the specification [0100-0101] allows for up to 5 wt% of stearamidopropyl dimethylamine, resulting in a total amount of ingredients in claim 18 of 55.5 wt%. This is inconsistent with a composition “consisting of” the ingredients of claim 18. In addition, Claim 31 required the composition to be a liquid. It is unclear how the composition may consist of the ingredients recited in Claim 18 given the instant Specification and claims.
Applicant further argues that the composition, carrier, or diluent are not stated in the specification to require water, and the composition may be in the form of a powder.
This is not found persuasive. The claims are not limited to a powder (see for example claims 30 and 31) and do not claim a separate powder and excipient. However, regardless of the presence or absence of water, there is not support for a composition “consisting of” the claimed ingredients for the reasons above.
Conclusion
No claim is allowed.
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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/NICOLE P BABSON/ Primary Examiner, Art Unit 1619
