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
This is a response to Applicant’s communication filed on December 2, 2025. Application No. 18/332,751, filed June 12, 2023, is a U.S. Nonprovisional application, and claims the benefit of U.S. Provisional application No. 63/496,688, filed April 17, 2023. Claims 1-19 are pending.
Election/Restriction
Applicant’s election of the invention of Group I and the PPARγ agonist, rosiglitazone in the reply filed on December 2, 2025, are acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 6-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. The elections were made without traverse in the reply filed on December 2, 2025.
Please note that upon finding allowable subject matter in the elected invention of Group I, the invention of Group II is not subject to rejoinder. Canceling claims 7-14 in response to this Office action is suggested.
Claims 1-5 and 15-19 are examined below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to nonstatutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter. See MPEP 2173.05(q) “Use” Claims. “Use” claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 15-19 are also rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. Claims 15-19, drawn to Non-Statutory “use” claims, are indefinite for failing to provide a “step” of utilizing. See MPEP 2173.05(q) “Use” Claims.
Claim Rejections - 35 USC § 102(a)(1)
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pan et al., 202 Experimental Eye Research 108332 (2021) (available online Nov. 2., 2020) (cited on the August 11, 2023, IDS). Pan discloses a method of treating a refractive disorder (myopia and hyperopia), comprising administering a PPARγ agonist (GW9662 and GW1929) . See Pan et al., Abstract.
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-4 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a method of treating a refractive disorder comprising administering the PPARγ agonist, rosiglitazone, the specification does not reasonably provide enablement for a method of treating a refractive disorder comprising administering any other PPARγ agonist(s). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Factors to be considered when determining whether claims in an application for patent are enabling include (1) the breadth of the claims, (2) the nature of the invention, (3) the state of the prior art, (4) the level of one of ordinary skill, (5) the level of predictability in the art, (6) the amount of direction provided by the inventor, (7) the existence of working examples, and (8) the quantity of experimentation needed to make or use the invention based on the content of the disclosure. See MPEP § 2164.08, citing In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The claims include administering any PPARγ agonist, including any thiazolidinedione based PPARγ agonist. However, the specification teaches only administering the PPARγ agonist rosiglitazone. (Specification, Examples 1 and 2, p. 10-12.) There is no evidence that any other PPARγ agonist can treat a refractive disorder as generally claimed. In addition, the prior art fails to provide compensatory guidance. For example, in Pan (cited above in the 35 U.S.C. 102(a)(1) above) the PPARγ agonists GW9662 and GW1929 are not thiazolidinedione based PPARγ agonists. Accordingly, there is no correlation between treating a refractive disorder(s) and using any-and-all PPARγ agonist as presently claimed. It would require undue experimentation for the artisan to practice the invention as broadly claimed.
Conclusion
Claims 1-4 are not allowed.
Claim 5 is 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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached on Monday - Friday, 9:00 a.m. -5:00 p.m..
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached on (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TIMOTHY R ROZOF/
Primary Examiner, Art Unit 1625