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 with traverse of Group II with a species election of increasing skin thickness in the reply filed on October 16, 2025 is acknowledged. The traversal is on the ground(s) that searching all groups of the species election is not a search burden. As the entire scope of the claim has been previously examined in the parent application (16/613,719), the Examiner has reconsidered the election of species requirement. The election requirement is hereby withdrawn.
Applicant did not traverse the restriction requirement of Groups I-III. It is noted that Applicant has cancelled the non-elected groups.
The restriction requirement is still deemed proper and is therefore made FINAL.
Status of Application
Receipt of the Preliminary Amendment filed on January 26, 2024 is acknowledged.
Receipt of the Amendment to the specification filed on Marc 26, 2024 is acknowledged.
Receipt of Applicant’s arguments and amended claims filed on October 16, 2025 is acknowledge.
Claims 40 and 49-65* are pending in this application.
Claims 1-39 and 41-48 have been cancelled.
Claims 49-65* are new.
Claims 40 and 49-65* are under prosecution, in the scope they read on the elected species, as noted above.
*as noted below, misnumbered claim 17 been renumbered 65.
Information Disclosure Statement
No Information Disclosure Statements have been submitted in this application.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 17 been renumbered 65. Correction of the claim set is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 40 and 49-65 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 40, the claim recites (iiib) at least one binder/stabilizer and (iiic) includes a binder in the Markush group. Since (iiif) is any combination of at least two of any iiia-iiie, it is unclear if the recitation of a “binder” in (iiib) and (iiic) is intended to represent different components or the same component. Applicant is requested to review the claims for redundancy. Clarification is requested.
Regarding claim 50, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 50 recites the broad recitation the “polyamine is putrescine or dansylcadaverine”, and the claim also recites “preferably putrescine” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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.
Claims 40, 49-51, 57-58, 61, and 63-64 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lovaas (US 2008/0124312).
Lovaas discloses topical cosmetic or cosmeceutical compositions comprising polyamines (paragraph 0001). Lovaas discloses polyamines (i.e. polyazaalkanes) have been long known to exert an antioxidant effect and have been proposed as components for topical treatment products (paragraph 0010).
An unbranched aliphatic polyamine topical skin treatment composition for use in the topical treatment of skin to achieve at least one of the effects of combating age-related skin pigmentation, promoting skin elasticity, enhancing skin color, and enhancing skin smoothness (paragraph 0018).
The compositions may be in any form suitable for topical application, including creams, gels, solutions, emulsions, dispersions, suspensions, etc. They may contain conventional topical composition components including solvents, oils, aromas, colorants, pH modifiers, viscosity modifiers, binders, diluents, emollients, antioxidants, skin irritants including alpha hydroxy acids, thickeners, vitamins including vitamin A, vitamin C, vitamin B6, and vitamin E, preservatives, stabilizers, humidifiers, skin penetration enhancers including DMSO, vesicle wall formers, etc. (paragraph 0035; 0040; ). These components are generally present in the amount of 0.001 to 20% of the composition (paragraph 0037).
The compositions are preferably for application to: (a) the hands (especially for combating age-related pigmentation); (b) the breasts; (c) the thin skin under the eyes; (d) the upper arm (especially the surface adjacent the torso); (e) the undersurface of the chin; and (f) the décolletage (i.e. the area exposed by an open-necked shirt) (paragraph 0039).
Example 2 discloses a aqueous topical formulation comprising 0.05-0.04% spermine (polyamine), 0.05-0.1% tocopherol (vitamin E); 1-3% polyquaterium-10 (rheological modifier), and 0.5-1.0% sodium hyaluronate (skin conditioning agent) which anticipate an aqueous topical composition comprising a polyamine and at least two of any one of (a) to (e) recited in instant claim 40.
Regarding claim 49, as noted above, Example 2 discloses a aqueous topical formulation comprising 0.05-0.04% spermine (polyamine), 0.05-0.1% tocopherol (vitamin E); 1-3% polyquaterium-10 (rheological modifier), and 0.5-1.0% sodium hyaluronate (skin conditioning agent).
Regarding claims 50-51, Lovaas discloses particularly useful polyamides include putrescine, spermidine, and spermine (paragraph 0027). The polyamine is present in the amount of 0.0005 to 5% of the composition (paragraph 0033).
Regarding claim 57, Example 2 discloses the use of ubiquinone (CoQ10), which is an antioxidant.
Regarding claim 58, Example 1 discloses the use of dimethicone, which is a stabilizer and also meets the limitations of a skin conditioning agent, emollient, moisturizer, and solvent.
Regarding claim 61, as noted above, Example 2 discloses ubiquinone (coQ10) and tocopherol.
Regarding claim 63, Example 2 discloses the use of tocopherol, tocopheryl acetate, sodium hyaluronate, ubiquinone, retinyl palmitate, prunus armeniaca, panthenol, and helianthus, for example, which are all active ingredient.
Regarding claim 64, Example 1 discloses 61-66% water.
Lovaas, therefore, anticipates the rejected claims.
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.
Claims 40, 49-52, 57-58, 61, and 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Lovaas (US 2008/0124312).
The teachings of Lovaas are discussed above.
Lovaas does not exemplify a tripeptide in the topical formulation.
Regarding claim 52, Lovaas discloses glutathione is an acceptable excipient. It is noted that glutathione is a tripeptide (paragraph 0024).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included glutathione in the topical formulation in order to obtain its therapeutic effects since it is disclosed as physiologically tolerable carrier or excipient.
Claims 40, 49-53, 57-58, 61, and 63-65 are rejected under 35 U.S.C. 103 as being unpatentable over Lovaas (US 2008/0124312) in view of Hahn et al. (US 7,404,967).
The teachings of Lovaas are discussed above.
Lovaas does not disclose the use of magnesium aluminum silicate as a viscosity increasing agent in the composition.
Hahn discloses a topical product formation for reducing skin irritation.
Regarding claims 53 and 65, Hahn discloses suitable viscosity adjusting agents include magnesium aluminum silicate and xanthan gum (column 19, lines 4-20).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included magnesium aluminum silicate and xanthan gum as the viscosity enhancing agents in the topical formulation of Lovaas since both formulations are designed for topical application and for reducing skin inflammation, as well as their routine use as viscosity enhancing agents in the art.
Claims 40, 49-52, 54, 57-58, 61, and 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Lovaas (US 2008/0124312) in view of Gordon et al. (US 5,977,039).
The teachings of Lovaas are discussed above.
Lovaas does not disclose the use of squalene as skin conditioning agent in the composition.
Gordon discloses topical skin compoisition comprising conditioning and moisturizing ingredients (column 3, lines 26-27).
Regarding claim 54, examples of conditioning and moisturizing ingredients include squalane (column 3, lines 40-41).
Regarding claim 62, the pH of the composition is 4 to 8 (column 8, lines 13-17).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included squalane as the conditioning and moisturizing agents in the topical formulation of Lovaas since both formulations are designed for topical application and for reducing skin inflammation, as well as their routine use as such agents in the art.
Claims 40, 49-52, 55, 57-58, 61, and 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Lovaas (US 2008/0124312) in view of Bosko et al. (WO 2012/013418A2)
The teachings of Lovaas are discussed above.
Lovaas does not disclose the use of a blend of glyceryl stearate and PEG-100 stearate.
Bosko discloses a topical skin care composition (abstract).
Regarding claim 55, Example 5 discloses the use of 2.00% PEG-100 stearate and 1.50% glycerol monostearate, which meets the limitations of the instant claim.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included the mixture of PEG-100 stearate and glycerol stearate as the conditioning and moisturizing agents in the topical formulation of Lovaas since both formulations are designed for topical application and for reducing skin inflammation, as well as their routine use as such agents in the art.
Claims 40, 49-52, 57-58, 61, and 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Lovaas (US 2008/0124312) in view of Singleton et al. (US 2005/0209131).
The teachings of Lovaas are discussed above.
Lovaas does not disclose the rheology modifier being a blend of acrylates/acrylamide, mineral oil, and polysorbate-85.
Singleton discloses a topical application of an aqueous cosmetic composition (paragraph 0026).
Regarding claim 56, the topical formations can comprise polysorbate-85 (paragraph 0031); acrylates/acrylamides; and gelling agents including mineral oil (paragraph 0034).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included the specific rheology agents in the topical formulation of Lovaas since both formulations are designed for topical application and for reducing skin inflammation, as well as their routine use as such agents in the art.
Claims 40, 49-52, 57-61, and 63-64 are rejected under 35 U.S.C. 103 as being unpatentable over Lovaas (US 2008/0124312) in view of Mitra et al. (USA 8,409,154)
The teachings of Lovaas are discussed above.
Lovaas does not disclose cyclopentasiloxane and dimethiconol or hexamidine diisethionate in the topical formulation.
Mitra discloses compositions containing skin benefit agents for topical application (abstract).
Regarding claims 59-60, Table 2 of Mitra discloses suitable excipients in topical skin care composition include cyclopentasiloxane and dimethiconol mixture and hexamidine diisethionate.
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have included a mixture of cyclopentasiloxane and dimethiconol and hexamidine diisoethionate as the stabilizer in the topical formulation of Lovaas since both formulations are designed for topical application and for reducing skin inflammation, as well as their routine use as stabilizing agents in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 5:30 am to 4 pm EST.
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/MELISSA S MERCIER/ Primary Examiner, Art Unit 1615