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
Claims 1 and 2 are pending. Note that, the preliminary amendment filed March 14, 2025, has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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, 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.
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over WO2022/122896.
With respect to independent, instant claim 1,’896 teaches a cosmetic or pharmaceutical composition, comprising or consisting of: (a') a mixture comprising at least one first linear alkanediol having a carbon chain of 5 to 14 carbon atoms and one or more second linear alkanediol having a carbon chain of 5 to 14 carbon atoms, wherein the number of the carbon atoms of the first and the second alkanediol is either same or different; (b') at least one antioxidant; and (c') optionally at least one active substance for a cosmetic or pharmaceutical composition or homecare product and/or additive. See pages 10 and 11. The cosmetic or pharmaceutical, preferably dermatological, composition according to the present invention preferably includes one or more anionic and/or amphoteric or zwitterionic surfactants, wherein suitable surfactants include PEG-75 dilaurate, PEG 150 dilaurate, PEG-30 glyceryl oleate, etc. See pages 120-135. The cosmetic or pharmaceutical, preferably dermatological, composition according to the present invention may comprise a carrier or a mixture of different carriers. Preferred cosmetics carrier materials are solid or liquid at 25°C and 1013 mbar (including highly viscous substances) as for example glycerol, 1 ,2-propylene glycol, 1,2-butylene glycol, 1,3-propylene glycol, 1,3-butylene glycol, ethanol, water, and mixtures of two or more of said liquid carrier materials with water. See para. 168. The cosmetic or pharmaceutical, in particular dermatological, composition according to the first or second aspect of the present invention can be present in different forms such as an aqueous based solution. See para. 351. Preferably, the overall water content in the final composition of such compositions can be ~ 60 %, more preferably ~ 70 %, even more preferably ~ 80 %, and even more preferably ~ 90 %. See para. 363.
‘896 does not teach, with sufficient specificity, a solution containing a compound of Formula(a) as recited by independent, instant claim 1 and the respective dependent claims.
Nonetheless it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a solution containing a compound of Formula(a) as recited by independent, instant claim 1 and the respective dependent claims, with a reasonable expectation of success and similar results with respect to other disclosed components, because the broad teachings of ‘896 suggest a solution containing a compound of Formula(a) as recited independent, instant claim 1 and the respective dependent claims.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Gadek et al (US 8,592,450).
With respect to independent, instant claim 1, Gadek et al teach compositions which are suitable for the treatment of eye disorders such as dry eyes. See column 2. Surfactants which can be used to form pharmaceutical compositions and dosage forms of the invention include, but are not limited to, hydrophilic surfactants, lipophilic surfactants, and mixtures thereof. That is, a mixture of hydrophilic surfactants
may be employed, a mixture of lipophilic surfactants may be employed, or a mixture of at least one hydrophilic surfactant and at least one lipophilic surfactant may be employed. See column 52. Non-ionic surfactants include, without limitation, PEG-10 laurate, PEG-12 laurate, PEG-20 laurate, PEG-32 laurate, PEG-32 dilaurate, PEG-12 oleate, PEG-15 oleate, PEG-20 oleate, PEG-20 dioleate, PEG-32 oleate, PEG-200 oleate, PEG-400 oleate, PEG-15 stearate, PEG-32 distearate, PEG-40 stearate, PEG-30 glyceryl oleate, etc. See column 53. Eye drops may be prepared by dissolving the active ingredient in a sterile aqueous solution such as physiological saline, buffering solution, etc. See column 55, lines 55-69.
Gadek et al not teach, with sufficient specificity, a solution containing a compound of Formula(a) as recited by independent, instant claim 1 and the respective dependent claims.
Nonetheless it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a solution containing a compound of Formula(a) as recited by independent, instant claim 1 and the respective dependent claims, with a reasonable expectation of success and similar results with respect to other disclosed components, because the broad teachings of Gadek et al suggest a solution containing a compound of Formula(a) as recited independent, instant claim 1 and the respective dependent claims.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Gadek et al (US 8,592,450) as applied to claim 1 above, and further in view of WO2022/122896.
Gadek et al are relied upon as set forth above. However, Gadek et al do not teach the use of a compound such as PEG-75 dilaurate or PEG-150 dilaurate as recited by the instant claims.
‘896 is relied upon as set forth above.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to use PEG-75 dilaurate or PEG-150 dilaurate
with a reasonable expectation of success and similar results with respect to other disclosed components, because ‘896 teach the equivalence of PEG-30 glyceryl oleate to PEG-75 dilaurate or PEG-150 dilaurate as surfactant in a similar composition and further, Gadek et al teach the use of PEG-30 glyceryl oleate and a wide variety of nonionic surfactants in general.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Remaining references cited but not relied upon are considered to be cumulative to or less pertinent than those relied upon or discussed above.
Applicant is reminded that any evidence to be presented in accordance with 37 CFR 1.131 or 1.132 should be submitted before final rejection in order to be considered timely.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GREGORY R DEL COTTO whose telephone number is (571)272-1312. The examiner can normally be reached M-F, 8:30am-6:00pm, EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Angela Brown-Pettigrew can be reached at (571) 272-2817. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GREGORY R DELCOTTO/Primary Examiner, Art Unit 1761
/G.R.D/September 29, 2026