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 .
Claim Status
Claim listing filed on December 18, 2025 is pending. Claims 1-10 and 13-14 are canceled. Claims 11-12 and 15-16 are amended. Claim 17 is new. Claims 11-12 and 15-17 are examined upon their merits.
Withdrawn Objections and Rejections
Applicant’s cancelation of Claims 8-9 and 13-14 have rendered all previous rejections directed to these claims moot.
Applicant’s amendments to the specification, drawings, and claims have overcome all objections of record. As such, the specification objections, drawing objections, and claim objections are all withdrawn.
The rejection of Claims 11-12 and 15-16 under 35 U.S.C. 112(b) as being indefinite are withdrawn in view of Applicant’s amendments. In particular, the phrase “an agent which increases PAX6 gene and/or protein expression” has been deleted from the claims.
The rejection of Claim 12 under 35 U.S.C. 112(a) as failing to comply with the written description requirement and enablement requirement is withdrawn in view of Applicant’s amendments. In particular, “wherein the subject has diabetes” distinguishes that the method is treating an established disease and does not encompass preventing the onset of diabetes.
Claim Objections (New, necessitated by amendment)
Claim 17 is objected to because of the following informalities: “the method of claim 11” should have a comma after the preamble to recite “the method of claim 11, wherein the subject has aniridia.” Appropriate correction is required.
Claim Rejections - 35 USC § 112 (Maintained)
The rejection of Claims 11 and 15-16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is maintained. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to Claims 11, 15, and 16 and the cancelation of Claims 8, 13, and 14 fully address the written description rejection. However, Claim 11 still recites “a method for treating diabetes and/or aniridia” (emphasis added). It is of record in the non-final rejection filed 09/22/2025 that the specification defines “treating” as “both prophylactic or preventive treatment as well as curative or disease modifying treatment” (specification page 3, first paragraph). Examiner defined the term “therapeutically treating” to encompass treating an established disease which is distinct from preventing disease onset. As stated in the written description rejection of record (filed 09/22/2025), the specification does not teach any working examples of prophylactically administering duloxetine, ritanserin, or topotecan to prevent the onset of diabetes or aniridia. The allowable subject matter indicated in the non-final office action filed 09/22/2025 stated that “a method of therapeutically treating (distinct from preventing) diabetes and/or aniridia by administering duloxetine, ritanserin, topotecan, and/or a derivative thereof is both enabled and free of the prior art” (emphasis added). As currently claimed, the method still includes preventing.
Alternative claim language to exclude preventing could recite “a method for ameliorating diabetes and/or aniridia” or “a method for treating diabetes and/or aniridia in a subject diagnosed with diabetes and/or aniridia comprising…” or “a method for treating diabetes and/or aniridia in a subject in need thereof comprising a step of administering to said subject a therapeutically effective amount of duloxetine, ritanserin, topotecan and/or a derivative thereof wherein the subject has diabetes and/or aniridia.”
The rejection of Claims 11 and 15-16 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, is maintained because the specification, while being enabling for therapeutically treating subjects diagnosed with diabetes and/or aniridia by administering duloxetine, ritanserin, and/or topotecan, does not reasonably provide enablement for preventing the onset of diabetes and/or aniridia by prophylactic administration. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Applicant's arguments filed December 18, 2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to Claims 11, 15, and 16 and the cancelation of Claims 8, 13, and 14 fully address the enablement rejection. However, Claim 11 still recites “a method for treating diabetes and/or aniridia” (emphasis added), and it is of record in the non-final rejection filed 09/22/2025 that the specification defines “treating” as “both prophylactic or preventive treatment as well as curative or disease modifying treatment” (specification page 3, first paragraph). As stated on record in the non-final rejection filed 09/22/2025, the state of the art teaches the inability to prevent aniridia and diabetes even after the effective filing date. Specifically, Maguire 2023 (of record) teaches that aniridia cannot be prevented because it is a hereditary and congenital eye disorder (under ‘Can it be prevented?’). The US Center for Disease Control 2024 (of record) teaches that type 1 diabetes can be effectively treated, but it cannot be prevented (Key Points). There is no support in the Applicant’s disclosure leading one of ordinary skill to overcome this inability to prevent the onset of diabetes and/or aniridia by prophylactically administering duloxetine, ritanserin, and/or topotecan.
Alternative claim language to exclude preventing could recite “a method for ameliorating diabetes and/or aniridia” or “a method for treating diabetes and/or aniridia in a subject diagnosed with diabetes and/or aniridia comprising…” or “a method for treating diabetes and/or aniridia in a subject in need thereof comprising a step of administering to said subject a therapeutically effective amount of duloxetine, ritanserin, topotecan and/or a derivative thereof wherein the subject has diabetes and/or aniridia.”
Allowable Subject Matter
Claims 12 and 17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
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.
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 SARAH COOPER PATTERSON whose telephone number is (703)756-1991. The examiner can normally be reached Monday - Friday 8:00am - 5:00pm EST.
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/SARAH COOPER PATTERSON/ Examiner, Art Unit 1675
/JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675
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