DETAILED ACTION
Status of Application
The Examiner acknowledges receipt of the amendments filed on 4/16/2026 wherein claims 1, 5, 8, 10, 15, 16 and 21 have been amended.
Claims 1, 4, 5, 8, 10 and 14-21 are presented for examination on the merits. The following rejections are made.
Response to Applicants’ Arguments
Applicant’s amendments/arguments filed 4/16/2026 overcomes the rejection of claims 1, 3, 5, 8 and 14 made by the Examiner under 35 USC 102 over Spann-Wade et al. (US 2007/0053984), evidenced by Silveria et al (Quim Nova, 34(s), 2011, 292-299). This rejection has been withdrawn.
Applicant’s amendments/arguments filed 4/16/2026 overcomes the rejection of claims 4, 10 and 15-19 made by the Examiner under 35 USC 102 over Spann-Wade et al. (US 2007/0053984), evidenced by Silveria et al (Quim Nova, 34(s), 2011, 292-299), further in view of Stier (US 2009/0091514). This rejection has been withdrawn.
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.
Claims 1, 4, 5, 8, 10 and 15-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karles et al. (US 2011/0104218), evidenced by Barak et al. (Int J Biological Macromolecules, 66, 2014, 74-80), in view of Street et al. (US 2014/0322385).
Karles is directed to a hydrogel composition. The hydrogel is to comprise a stabilizing agent such as guar gum and locust bean gum in an amount of 0.001-10% by weight (see [0051]) (see instant claims 1, 4, 5, 8, 10, 15-21). Locust bean gum is a galactomannan obtained from the endosperm of the carob tree (see pages 74 and 75 of Barak). See MPEP 2144.05 regarding the obviousness of overlapping ranges. The composition may also comprise a pigments/coloring agent in an amount of 0.001-5 % by weight (see [0053]). The hydrogel may comprise additional agents such as antioxidants, flavorants, plasticizers and surfactants which are broadly considered ‘pharmaceutically acceptable excipients.
Karles fails to teach the composition as comprising lycopene in an amount of 0.0001-1%.
Street teaches a chewing gum composition that forms a hydrogel when chewed. The composition comprises a hydrocolloid material such as locust bean gum, galactomannans, guar gum, etc. in an amount of 0.01-2% by weight (see [0055]). The composition may also comprise a colorant additive such as lycopene and turmeric in an amount of 0.005-1.25% by weight (see [0053]) (see instant claims 1, 5, 8, 20 and 21). It would have been obvious to modify Karles’s composition to include lycopene and turmeric as pigments for providing color the resulting composition. The selection of a known material (e.g. lycopene, turmeric) based on its suitability for its intended use (colorant) is supportive of obviousness. See MPEP 2144.07.
Regarding the intended use limitations and their outcomes as recited by instant claims 1, 5, etc. (e.g. 'for use in therapeutic and/or cosmetic treatment of skin lesions in mammals'), the intended use limitations fail to add any structural element to the otherwise complete composition claimed. Instead, the limitations provide a means for which the composition may be used which fails to provide any structural limitation to the claimed composition. See MPEP 2111.02(II).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Karles et al. (US 2011/0104218), evidenced by Barak et al. (Int J Biological Macromolecules, 66, 2014, 74-80), in view of Street et al. (US 2014/0322385) as applied to claims 1, 4, 5, 8, 10 and 15-21 above, and further in view of Spann-Wade et al. (US 2007/0053984; of record).
Although Karles teaches their composition being in the form of a hydrogel, Karles fails to teach the viscosity of said hydrogel as being between 25,000-70,000 mPas.
Spann describes a topical gel composition comprising a thickening agent comprising gums (see [0055]) such as gum tragacanth (see [0219]) in an amount of between about 0.1-5% of the composition (see [0220]) (see instant claims 1, 10 and 15-21). It is noted that gum tragacanth naturally comprises galactomannan (see evidence to Silveira et al., page 296) as required by instant claims 1 and 8. The composition may also include antioxidants. Exemplified antioxidants include carotenoids and carotenes such as beta-carotene and lycopene (see [0229]) (see instant claims 1, 3 and 8) wherein the antioxidant is present in an amount of between about 0.001-30% by weight of the composition (see [0230]) (see instant claims 10, 20 and 21).
The composition may take the form a hydrogel (see [0084]) (see instant claim 13) having a viscosity of between about 2,000-50,000 cps (see [0029, 0225]) (see instant claim 14). As it was known that galactomannan and lycopene containing hydrogels may possess a viscosity up to 50,000 cps, one of ordinary skill in the art would be able to use this framework to modify the physical property of Karles hydrogel to arrive at a formulation having a viscosity overlapping with that claimed.
Conclusion
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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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