CTNF 18/264,286 CTNF 66646 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claims 1-11 and 14-19 are presented for examination. Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 1-11 and 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bouvier (20160166569) in view of Kandula (US 20210188817) . The claims are drawn to a composition in a form suitable for topical administration comprising: a water base, and a vasoconstrictor, chosen from brimonidine or salts thereof, wherein the vasoconstrictor is in a solvent-based phase comprising: polyethylene glycol in combination with propylene glycol and/or dimethyl sulfoxide (DMSO); a hydrophilic film-forming agent chosen from a polyvinylpyrrolidone / vinyl Acetate copolymer, and/or polyvinylpyrrolidone in a non-crosslinked, crosslinked or acetate form; and glycerin; wherein the composition is in the form of a hydrogel. Regarding claim 1, Bouvier teaches Methods, compositions and products for treating or reducing skin thickening in a subject. Bouvier teaches methods of inhibiting a skin disorder induced by an UV-irradiation. The methods involve topically administering to the subject a composition containing an et adrenergic receptor agonist, such as brimonidine. See the abstract. Bouvier teaches the viscosity adjusting agents for example, but not limited to are polyvinyl alcohol, povidone, hydroxypropyl methyl cellulose, poloxamers (polyethylene-propylene copolymer), carboxymethyl cellulose, or hydroxyethyl cellulose. See Para [0067]. The use of glycerin is taught in Para [0066]. The use of the formulation in a gel form is taught in Table example 3, tables 4 and 5. Bouvier makes clear that brimonidine in combination with the claimed viscosity adjusting agent/polymers have been previously used in a pharmaceutical formulations. To select polymers within the scope of Bouvier would have been obvious to a person skilled in the art in the absence of evidence to the contrary. Being a hydrogel is the inherent property of Bouvier, since it uses the polymers as claimed herein in combination with brimonidine. Furthermore, Bouvier teaches the use of brimonidine in a gel form. Regarding claim 2, Bouvier in table 10 teaches polyvinylpyrrolidone/vinyl acetate copolymer . Regarding claim 3, Bouvier teaches the use of hydroxyethyl cellulose. See Para [0067]. Regarding claim 4 , Bouvier teaches the use of an antioxidant. See Para [0069]. Regarding claim 5, Bouvier teaches the use of the claimed antioxidants, such as, Butylated hydroxytoluene (BHT). See Para (0096). Kandula also teaches a composition comprising brimonidine being used for the treatment of skin and eye disorders. See the abstract and Para [0017]. Kandula teaches that the composition can be in a gel form. See Para [0029]. Kandula teaches that Examples of antioxidants include, but are not limited to, tocopherols, ascorbic acid, sodium pyrosulfite, butylhydroxytoluene, butylated hydroxyanisole, edetic acid, and edetate hydrates or solvates, and mixtures thereof. See Para [0076]. Regarding claim 6, Bouvier teaches Butylated hydroxytoluene (BHT) at the concentration of 0.01%. See Para [0096]. However, the determination of optimum proportions and amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Applicant’s attention are drawn to In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), where the court states “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. Regarding claim 7 , kandula teaches the use of polysorbate as an emulsifier. See Para [0113]. Regarding claim 8, Bouvier teaches the concentration of brimonidine tartrate in a gel is 0.01-5%. See Para [0089]. The claimed brimonidine concentrations are within the scope of the composition of Bouvier. The determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Regarding claim 9, Bouvier teaches the use of brimonidine in a tartrate form. See Para [0089]. Regarding claim 10, Bouvier teaches the concentration of carbomer, which is a polyethylene-propylene copolymer at the concentration of 1-1.25%. However, the determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Regarding claim 11, Kandula teaches that one example of antioxidants is tocopherols (vitamin E). See Para [0076]. Regarding claim 14 , Bouvier teaches Butylated hydroxytoluene (BHT) at the concentration of 0.01%. See Para [0096]. However, the determination of optimum proportions and amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Regarding claim 16, Bouvier teaches the concentration of brimonidine tartrate in a gel is 0.01-5%. See Para [0089]. The claimed brimonidine concentrations are within the scope of the composition of Bouvier. The determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary. Regarding claim 17, Bouvier teaches the concentration of brimonidine tartrate in a gel is 0.01-5%. See Para [0089]. The claimed brimonidine concentrations are within the scope of the composition of Bouvier. The determination of optimum proportions or amounts are considered to be within the skill of artisan in the absence of evidence to the contrary . Regarding claim 18, Kandula teaches a composition comprising brimonidine being used for the treatment of skin and eye disorders. See the abstract and Para [0017]. Kandula teaches that the composition can be in a gel form. See Para [0029]. Kandula teaches that Examples of antioxidants include, but are not limited to, tocopherols, ascorbic acid, sodium pyrosulfite, butylhydroxytoluene, butylated hydroxyanisole, edetic acid, and edetate hydrates or solvates, and mixtures thereof. See Para [0076]. Therefore, the mixture of the antioxidants of claim 18 is taught by Kandula. Regarding Claim 19 , Bouvier teaches Methods, compositions and products for treating or reducing skin thickening in a subject . Bouvier teaches methods of inhibiting a skin disorder induced by an UV-irradiation. The methods involve topically administering to the subject a composition containing an alpha adrenergic receptor agonist, such as brimonidine. See the abstract. Bouvier teaches that the skin thickening can be associated with dermatitis. See Para [0033]. Bouvier does not specifically teach the treatment of dermatitis per se. However, Kandula teaches the use of brimonidine for the treatment of dermatitis. See Para [0030]. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZOHREH A FAY whose telephone number is (703)756-1800. The examiner can normally be reached Monday-Friday 9:30AM-6:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ZOHREH A FAY/Primary Examiner, Art Unit 1617 Application/Control Number: 18/264,286 Page 2 Art Unit: 1617 Application/Control Number: 18/264,286 Page 3 Art Unit: 1617 Application/Control Number: 18/264,286 Page 4 Art Unit: 1617 Application/Control Number: 18/264,286 Page 5 Art Unit: 1617 Application/Control Number: 18/264,286 Page 6 Art Unit: 1617 Application/Control Number: 18/264,286 Page 7 Art Unit: 1617