No 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 .
Priority
The present application was filed July 26, 2022.
Status of the Claims
In the amendment filed October 30, 2025, claims 9-11, 14, and 16-17 are canceled and claims 1 and 19 are amended. Claims 2, 4, and 18 were previously canceled. Claims 1, 3, 5-8, 12-13, 15, and 19 are pending.
Continued Examination Under § 37 CFR 1.114
A request for continued examination under 37 CFR § 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR § 1.114, and the fee set forth in 37 CFR § 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR § 1.114. Applicant's submission filed on September 11, 2025 has been entered.
Previous Rejections and/or Objections
Any objections and/or rejections raised in the previous Office Action but not reiterated below are considered to have been withdrawn due to amendment.
Claim Rejections - 35 USC § 112(a) – Necessitated by Amendment
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 5-8, 12-13, 15, and 19 fail to comply with the written description requirement:
Claims 1, 3, 5-8, 12-13, 15, and 19 are rejected under 35 U.S.C. § 112(a), as failing to comply with the written description requirement. The claims contains 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 inventors, at the time the application was filed, had possession of the claimed invention.
Specifically, Applicant does not have written description support for a method for inhibiting or delaying the onset of myopia in a non-myopic subject, comprising administering to the non-myopic subject a composition comprising about 0.05% atropine…wherein the subject has a Spherical Equivalent (SE) of an eye of more than or equal to +1.0 D before administration of the composition.
This is a new matter rejection. The disclosure states at pg. 3, lines 8-9, that, “[i]n certain embodiments, the Spherical Equivalent (SE) of the eye is about +1.00 D to greater than -0.5 D before administration of the composition.” The disclosure also states at pg. 9, lines 19-20, that, “[i]n certain embodiments, the subject has an SE value of about +1.00 D to -0.49 D, about 0.75 D to about -0.49 D, or about+ 1.00 D to about 0 D.”
Beginning at the bottom of pg. 13, the disclosure describes the study that provides the data for the present application. As such, this section (titled, Materials and Methods) describes the real examples of the present disclosure. At pg. 14, lines 9-10, the disclosure describes the selection criteria of the study, including that, “[e]ligible subjects are children aged 4 to 9 with a SE of 0 D to +1.0 D.”
At pg. 17, the disclosure further describes groupings of the study participants in a somewhat confusing manner (it appears that the directions of the “greater than/less than” signs may be reversed), but is otherwise consistent with the disclosure that all participants have SE less than or equal to +1.00 D.
In summary, the instant disclosure repeatedly indicates that the method is applied to subjects having a maximum SE of +1.0 D, and does not support that the method is applied to subjects having SE of an eye of more than or equal to +1.0 D before administration of the composition. Because the disclosure does not support the limitation added to claim 1 via amendment, this constitutes new subject matter, and claim 1 and its dependent claims fail to satisfy the written description requirement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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