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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-16 and 19) in the reply filed on 30 July 2026 is acknowledged.
Claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 30 July 2026.
Claims 1-16 and 19 are under current consideration.
Claim Objections
Claim 3 is objected to because of the following informalities: the term “ensulizole” is misspelled. Appropriate correction is required.
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.
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.
Claim(s) 1-2, 5-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gholap et al. (Pharmaceutics, 21 March 2023, Vol. 15, No. 3: 1008, pages 1-37).
Gholap et al. discloses sunscreen formulations including avobenzone UVA filter wherein photostabilizers may be used therein to reduce photodegradation thereof (abstract) wherein UV filter bemotrizinol can be included in formulations as an excellent avobenzone photostabilizer (Section 7.2.1 pages 9-10) wherein titanium dioxide or titanium dioxide coating physical UV filters can be included in formulations for avobenzone photostabilization (Section 7.5 page 21) wherein titanium dioxide nanoparticles and zinc oxide microparticles can be included therein (Section 7.8 pages 25-26) wherein ethylhexyl methoxycrylene is a commonly used avobenzone stabilizer (Section 7.6.3 pages 23-24).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Gholap et al. as discussed above and to make the sunscreen formulation of Gholap et al. with UVA filter avobenzone, UV filter and photostabilizer bemotrizinol, and UV filter and photostabilizer titanium dioxide coating or nanoparticles (i.e., particle diameters less than 1000 nm) therein, with a reasonable expectation of success.
Further regarding claim 5, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Gholap et al. as discussed above and to make the sunscreen formulation of Gholap et al. as discussed above with zinc oxide additionally included therein, with a reasonable expectation of success.
Further regarding claims 8-9 and 11-12, although Gholap et al. does not disclose such amounts/ratios, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize UV filtering and avobenzone stabilization by varying the amounts/ratios of UVA filter avobenzone, UV filter and photostabilizer bemotrizinol, and UV filter and photostabilizer titanium dioxide therein through routine experimentation per MPEP 2144.05(II) with a reasonable expectation of success, given that Gholap et al. discloses such ingredients as UV filter and photostabilizer actives, and also given that actives are result-effective variables. See, e.g., Ex parte Johnson, USPTO, PTAB Final Decision, Appeal 2014-005994, 2016 BL 301387, Application 13/355,217, page *10 ("well-known fact that drug concentration is a result effective variable"); Ex parte Armstrong, USPTO, PTAB Final Decision, Appeal 2016-4692, 2017 BL 222605, Application 13/834,281, page *3 ("a person skilled in the art, such as a medical practitioner, would have recognized that the concentration of an active agent used for disease treatment in patients . . . was a result effective variable, and that a determination of . . . concentration was a matter of routine optimization"); Ex parte Belder, USPTO, BPAI Final Decision, Appeal 2007-0185, Application 10/305,281, pages *7-*8 ("obvious to optimize the amount of drug in a tablet"; "A minor modification of the prior art, such as optimizing the amount of a particular ingredient, does not distinguish the claimed product from the prior art."; "experimentation needed to arrive at a drug dosage 'was nothing more than routine.'").
Further regarding claim 10, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to follow the suggestions of Gholap et al. as discussed above and to make the sunscreen formulation of Gholap et al. as discussed above with ethylhexyl methoxycrylene additionally included therein to further stabilize avobenzone, with a reasonable expectation of success.
Further regarding claims 13-16, such claimed properties are presumed inherent in the composition of Gholap et al. per MPEP 2112(V) and 2112.01(I), given that such composition is at least substantially identical to the claimed composition, and given that compositions that are physically the same must have the same properties per MPEP 2112.01(II).
Claim(s) 1-16 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gholap et al. as applied to claims 1-2, 5-16, and 19 above, and further in view of Meyer et al. (US 2007/0189993 A1; published 16 August 2007).
Gholap et al. is relied upon as discussed above.
Gholap et al. does not disclose phenylbenzimidazole sulfonic acid as in claims 3-4.
Meyer et al. discloses sunscreen compositions wherein phenylbenzimidazole sulfonic acid therein protects avobenzone therein from photodegradation (abstract).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Gholap et al. and Meyer et al. by including the phenylbenzimidazole sulfonic acid of Meyer et al. in the sunscreen composition of Gholap et al. as discussed above, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to further protect the avobenzone therein from photodegradation as suggested by Meyer et al., and given that Gholap et al. suggests the desirability of photostabilizing avobenzone in sunscreen compositions.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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