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 .
Response to Arguments
Applicant’s arguments, see Pages 1-3, filed 12/10/2025, with respect to the rejection(s) of claims 1, 3, 5 and 7-23 under Watabe (JP 2011231070 A), Yang (CN 109662925 A), Lu (CN 112294666 A), Ward et al. (US 20090054406 A1) and Rigas (US 20190343848 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Russ (WO 2009024346 A2) and Yang (CN 109662925 A).
The teachings of Yang from the previous office action and the teachings of Russ reads to the limitations of claimed invention of an ophthalmic topical cream composition comprising a zwitterion and an active pharmaceutical ingredient.
Applicant has canceled claim 21. Claims 1, 3, 5, 7-20 and 22-23 is now evaluated on its merits.
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 1, 3, 5, 7-17, 19 and 22-23 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Russ (WO 2009024346 A2).
Regarding claims 1, 3, 5, 7-17, 19 and 22-23, Russ teaches methods for the treatment of ocular disorders, in particular glaucoma, comprising administration of a therapeutically effective amount of a topical eye cream composition comprising a peptide of amino acid sequence X-Y or Y-X, wherein X is an aromatic amino acid and Y is one or more additional amino acid other than glycine in combination with at least one additional pharmaceutical agent selected from a list which includes timolol, brimonidine, travaprost, carbomer (a crosslinked acrylic acid polymer) and pilocarpine (relevant to claims 1, 7-8, 17 and 22-23) (abstract, para. 0014-0018). The peptides of amino acid sequences are shown in para. 0035 (relevant to claim 16).
In terms of claims 9-15, the teachings of Russ lead to the limitations of amino acids as the claims further limits claim 7 of the type and concentration of amino acids but does not state the zwitterion is an amino acid from the list of zwitterions of claim 7.
In terms of claims 5 and 19, it is known in the art Eye creams are generally formulated with a target pH of 6.0–7.5 to ensure comfort, with typical viscosities ranging from 80,000 to 150,000 cP to provide a thick, moisturizing texture that stays in place.
In terms of claim 3, it is known in the art the typical range of a small peptide or amino acid in an eye cream solution equates to roughly 10 mM to 100 mM.
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 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Russ (WO 2009024346 A2) in view of Yang (CN 109662925 A).
The teachings of Russ for the above 102 rejections over claims 1, 3, 5, 7-17, 19 and 22-23 are incorporated herein by reference.
Russ fails to teach the crosslinked polymer of carbomer less than 1% of the topical cream composition.
Yang teaches safe and non-irritating eye cream, which can effectively dodge black eye, and can greatly reduce the allergy phenomenon. The cream comprises API’s of betaine at .5-2.5 % weight (relevant to claim 20), arginine at 1-3.5% weight and crosslinked acrylic acid polymer of carbomer at 0.1-0.3 % weight (claims 1-5).
Therefore, it would have been obvious to someone of ordinary skill in the art at the time of filling to have administered the composition taught by Russ in which the carbomer is less than 1% and API between .002 and 10% of the topical eye cream composition. One would have been motivated to do so from the teachings of Yang of a topical eye cream composition comprising carbomer and an API at the claimed range and an amino acid of arginine. The teachings of Russ and Yang are of topical eye creams comprising carbomer, an API and an amino acid, thus one would reasonably use the weight amount of the carbomer and API from the teachings of Yang for the composition of Russ as a topical eye cream that would be safe to use.
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 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.
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MIKHAIL O'DONNEL. ROBINSON
Examiner
Art Unit 1627
/MIKHAIL O'DONNEL ROBINSON/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627