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
Status of Application
1. Applicants’ arguments/remarks filed 22 October 2025 are acknowledged. Claims 1, 7-9, and 12-17 are amended. Claims 18-20 are cancelled. Claims 1-17 are examined on the merits within.
Withdrawn Objections/Rejections
2. Applicants’ arguments, filed 22 October 2025, with respect to the claim objections have been fully considered and are persuasive. The objection of claim 17 has been withdrawn. The 35 U.S.C. 102 Rejections over Nath and Wagner have been withdrawn in view of the claim amendments. The 35 U.S.C. 103 Rejection including the prior art of Barrett et al. (U.S. Patent Application Publication No. 2010/0098645) has been withdrawn in view of the claim amendments. The 35 U.S.C. 103 Rejection of Nath (U.S. Patent Application Publication No. 2012/0283622) in view of Karlsson et al. (U.S. Patent Application Publication No. 2014/0275254) has been modified to include the prior art of Chesnoy et al. (U.S. Patent Application Publication No. 2011/0200544) in view of the claim amendments.
New Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. Claim(s) 1-13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Nath (U.S. Patent Application Publication No. 2012/0283622) in view of Karlsson et al. (U.S. Patent Application Publication No. 2014/0275254) and Chesnoy et al. (U.S. Patent Application Publication No. 2011/0200544).
Regarding instant claims 1, 3, and 9, Nath teaches treating nail fungus using a photochemically active substance and irradiating with LED. See abstract. Since Nath teaches the same method as instantly claimed, it would have been expected that the efficacy of the formulation increased.
Regarding instant claims 2 and 17-18, LED arrays may emit light in the violet spectral range around 405 nm or blue spectrum of 400 to 500 nm. See paragraphs [0042] and [0046].
Regarding instant claims 4 and 19, a timer limiting the exposure time by controlling the shutter can be integrated into the lamp housing. See paragraph [0051].
Regarding instant claim 11, Nath teaches an ointment or oil with a fungicide that can be better absorbed by tissue. See paragraph [0087].
Regarding instant claims 5, 7-8, and 12, the fungus-infected nail plate to be irradiated is covered by a peroxide containing gel (paste) or wetted with a peroxide containing liquid before the irradiation. See paragraph [0062].
Regarding instant claim 10, Nath teaches a shoe shaped optical shielding housing. See abstract.
Regarding instant claims 13-14, the formulation comprises carbamide peroxide and the overall peroxide content is about 15%. See paragraph [0063].
Nath does not teach propylene glycol or lactic acid.
Karlsson et al. teach compositions for topical application to the nail for treatment of nail diseases such as onychomycosis comprising a urea-based component, a diol component such as propylene glycol, lactic acid and glycerol. See abstract. The diol component is present in amounts of 50 to 70%. See paragraph [0058].
Chesnoy et al. teach a film forming solution comprising 10-20% urea, 5 to 15% film forming polymer, 45-65% polar solvent, 1 to 20% co-solvent, 0.01 to 5% of a plasticizer such as triethyl citrate, and water up to 100% for treating fungic infections. See abstract. The co-solvent may be propylene glycol. See paragraph [0040].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to combine 50-60% propylene glycol and lactic acid with the peroxide formulation of Nath to provide an effective formulation for fungal treatment. One would have been motivated, with a reasonable expectation of success, to formulate a storage stable formulation for treatment of nail fungal diseases. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add triethyl citrate to the formulation made obvious by Nath and Karlsson because Chesnoy et al. teach the effectiveness of triethyl citrate as a plasticizer for co-solvents such as propylene glycol. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to formulate the composition of Nath as a film strip as a matter of design choice because films comprising peroxide components are known to effectively treat fungal nail diseases.
5. Claim(s) 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nath (U.S. Patent Application Publication No. 2012/0283622) in view of Karlsson et al. (U.S. Patent Application Publication No. 2014/0275254) and Chesnoy et al. (U.S. Patent Application Publication No. 2011/0200544) as applied to claims 1-13 and 17 above and further in view of Mathur et al. (U.S. Patent Application Publication No. 2016/0120803).
Nath, Karlsson et al., and Chesnoy et al. do not teach phenoxyethanol, ethylhexylglycerin, or olive oil PEG-7 esters.
Mathur et al. teach liquid compositions suitable for topical administration. See abstract. The composition includes preservatives such as phenoxyethanol and ethylhexylglycerin. See claim 28. Emollients include olive oil PEG-7 esters. See claim 21. The active ingredient is suitable for use in nail psoriasis or anti-fungal treatments. See paragraph [0058].
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add phenoxyethanol and ethylhexylglycerin as preservative agents in the formulation made obvious by Nath, Karlsson et al. and Chesnoy et al. to increase storage stability. It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to add olive oil PEG-7 ester as an emollient to the composition dependent on the consistency and formulation desired. One would have been motivated, with a reasonable expectation of success, because Mathur et al. teach the effectiveness of these ingredients in topical formulations including anti-fungal agents.
Conclusion
6. Applicants’ 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Correspondence
7. No claims are allowed at this time.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615