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
Claims 53-72 are pending in the instant application.
Claims 58, 60, 64, 66, 70, and 72 are cancelled.
Claims 73-76 are new.
Claims 53-57, 59, 61-63, 65, 67-69, 71, and 73-76 are examined herein.
Priority
The instant application claims benefit of priority to U.S. Provisional Application No. 62899899, filed on 13 September 2019 and PCT/US2020/050540, filed on 11 September 2020. The claims to the benefit of priority are acknowledged. As such, the effective filing date of the claims is 13 September 2019.
Information Disclosure Statement
The information disclosure statements (IDS), submitted on 11 March 2022, 25 August 2022, 06 September 2024, and 22 September 2025, are acknowledged and considered. The submissions are in compliance with the provisions of 37 CFR 1.97.
Response to Arguments
The amendment filed on 15 August 2025 has been entered.
In view of applicant amendment to claim 1, the 102(a)(1) rejection of record over Xu is withdrawn.
In view of applicant amendment to claim 1, the 102(a)(1) rejection of record over Chauhan is withdrawn.
In view of applicant argument regarding the mouse models employed by Xu, the 103 rejection of record is withdrawn.
In addition, new 103 rejections are necessitated by amendment (see below).
All rejections and objections not found below have been withdrawn.
NEW REJECTIONS FACILITATED BY AMENDMENT
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
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.
Claims 53-57, 59, 61-63, 65, 67-69, 71, and 73-76 are rejected under 35 U.S.C. 103 as being unpatentable over Chauhan et al. (WO2019108602A1) in view of Bingaman et al. (US9446026B2).
Regarding claims 53, 54 and 55, Chauhan discloses a method of treating an eye disorder (claim 18); including AMD (paragraph [00124]), a disease characterized by retinal degeneration; comprising administering a composition comprising metformin (claim 7).
Chauhan does not teach administering the composition topically.
Bingaman teaches a topical ocular formulation comprising an active agent of Formula I, wherein the compound inhibits VEGF (Abstract) for the treatment of AMD (column 3).
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. Both Chauhan and Bingaman teach the treatment of AMD using an inhibitor of VEGF. Chauhan teaches intravitreal administration., while Bingaman teaches ocular formulation. Bingaman teaches away from intravitreal injections explaining complications can include infection, scarring, hemorrhage and inadvertent penetration of the globe (column 2, line 19). Whereas topical application allows for ease of application, direct application to the eye, and smaller doses resulting in reduced or nonexistent systemic exposure (column 2, line 5). It would be prima facie obvious to one of ordinary skill to apply the ophthalmic formulation taught by Bingaman to the composition taught by Chauhan to improve patient comfort, compliance, and to minimize dosing.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Regarding claim 56, Chauhan teaches the pharmaceutically acceptable carrier PBS (paragraph [00140]).
Regarding claim 57, 59, 65, 69, and 71, Bingaman teaches the composition formulates as eye drops (column 26, line 14).
Regarding claim 61 Chauhan teaches the method of administering an effective amount of metformin to a subject, defined as a vertebrate (paragraph [0060]). As the prior art teaches administering the claimed compound to the claimed patient population (defined by the instant specification as in animal in paragraph [0082]), in an effective amount it would appear that the claimed limitation of restoring retinal pigment epithelium cells degeneration necessarily occurs. MPEP 2112.01:I states:
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.”
Regarding claim 62, Chauhan discloses a method of administering a composition comprising metformin (claim 7) with the pharmaceutically acceptable carrier PBS (paragraph [00140]).
Regarding claims 67 and 68, Chauhan discloses a method of treating Stargardt’s disease (claim 19) comprising administering metformin (claim 7).
Regarding claims 74 and 76, Chauhan describes “treatment” as an approach to obtain desired clinical results. Chauhan’s definition of the term “desired clinical results” includes amelioration of one or more symptoms of a disease (paragraph [0061]). As Chauhan teaches the treatment of AMD, the amelioration of AMD symptoms is also taught.
Regarding claim 75, Chauhan discloses a method of treating an eye disorder (claim 18); including AMD (paragraph [00124]), a disease characterized by retinal degeneration; comprising administering a composition comprising metformin (claim 7).
Chauhan does not teach administering the composition as eyedrops.
Bingaman teaches a topical ocular formulation, in the form of eye drops (paragraph 26, line 14) comprising an active agent of Formula I, wherein the compound inhibits VEGF (Abstract) for the treatment of AMD (column 3).
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious.
In this case at least prong B of KSR applies – substitution of one known element for another. Both Chauhan and Bingaman teach the treatment of AMD using an inhibitor of VEGF. Chauhan teaches intravitreal administration., while Bingaman teaches eye drops. Bingaman teaches away from intravitreal injections explaining complications can include infection, scarring, hemorrhage and inadvertent penetration of the globe (column 2, line 19). Whereas topical application allows for ease of application, direct application to the eye, and smaller doses resulting in reduced or nonexistent systemic exposure (column 2, line 5). It would be prima facie obvious to one of ordinary skill to apply the ophthalmic formulation of eye drops taught by Bingaman to the composition taught by Chauhan to improve patient comfort, compliance, and to minimize dosing.
Thus, all of the elements of claims were known to one of ordinary skill in the art at the time the invention was made and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art at the time of invention. Therefore, the claimed invention, as a whole, would have been obvious to one of ordinary skill in that art at the time the invention was made.
Conclusion
Claims 53-57, 59, 61-63, 65, 67-69, 71, and 73-76 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jerica K Wilson whose telephone number is (703)756-4690. The examiner can normally be reached Monday-Friday 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.K.W./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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