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 June 29, 2026. Application No. 18/256,747, is a 371 of PCT/IL2021/051470, filed December 9, 2021, and claims the benefit of U.S. Provisional application No. 63/123,835, filed December 10, 2020. In a preliminary amendment filed June 9, 2023, Applicant cancelled claims 1-49 and added new claims 50-69. Claims 59-69 are currently withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. In an amendment filed June 29, 2026, Applicant cancelled claims 51, 52, 55, and 56. Claims 50, 53, 54, 57 and 58 are examined below.
Rejections Maintained
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.
The rejection of claims 50 and 58, as well as amended claims 53, 54, and 57 under 35 U.S.C. 101 because the claimed invention is directed to a product of nature, judicial exceptions without significantly more, is maintained for reasons made of record. (See MPEP 2106.) Applicant has amend claim 50 to incorporate the limitations of now cancelled claims 51, 52, 55, and 56. However, the incorporation of these limitations do not amount to something “significantly more than a judicial exception” in view of Applicant’s response to the 35 U.S.C. 102(a)(1), rejection below. Applicant’s response to the 102(a)(1) rejection below acknowledges and reaffirms that the critical component of the present invention is the 3,5,4’-trihydroxy-6,7,3’-trimethoxy flavone (TTF) isolated from achillea fragranissima (see claim 58). Applicant argues that “Elmann does not teach the use of TTF . . .. in treating, preventing, or ameliorating an eye disease or disorder.” June 9, 2026, Response, p. 6 of 7. As presently, construed the claims are not drawn to the use of the composition of claims 50, 53, 54, 57 and 58, but rather the composition itself. As Applicant notes the main component of the present invention is the TTF itself used to treat eye diseases or disorders. The additional components in this case do not amount to something significantly more than a judicial exception for purposes of obviating this rejection under 35 U.S.C. 101.
The claims recite an ophthalmic composition comprising 3,5,4’-trihydroxy-6,7,3’-trimethoxy flavone (TTF) and an ophthalmic acceptable carrier (i.e., saline). These judicial exceptions are not integrated into a practical application because TTF a natural product in a composition with a second component, saline, also a natural product, do not amount to “significantly more than the judicial exception”. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there is no evidence that mixing TTF with saline results in a markedly different structure or function relative to the individual components.
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.
The rejection of claims 50, 53, 54, 57, and 58 under 35 U.S.C. 102(a)(1) as being anticipated by Elmann et al., US2017/0020842 A1, is maintained for reasons made of record. Applicant argues that Elmann does not teach the use of TTF in preventing an eye disease and disorder or the noninvasive administration of TTF. Applicant’s argument is fully considered and is not persuasive.
As stated in the March 2, 2026, Non-Final Office action, Elmann discloses a composition comprising 3,5,4'-trihydroxy-6,7,3'-trimethoxyflavone (TTF) or a pharmaceutically acceptable salt or solvate thereof, and an ophthalmic acceptable carrier. See Elmann et al., ‘842 publc’n, Abstract; see also Id., paras. [0007]-[0030], for additional additives, carriers, and methods of administration; see specifically, Id., claim 64, wherein TTF is in the form of drug, food, medicinal food, food additive or beverage. Applicant asserts that intended use of the claimed composition distinguishes the invention over the prior art. In this case, the claims are drawn to a composition comprising TTF; and not to a method of using TTF (as are currently withdrawn claims 59-69). The intended use of the composition is not a limitation of the claimed invention.
As stated in the March 2, 2026, Non-Final Office action, the recited use or intended purpose of the claimed composition comprising TTF does not limit the claims. See MPEP 2111.02 II, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In this case, the body of the claim fully and intrinsically sets forth all of the limitations of the claimed invention, i.e., a composition comprising TTF. The composition disclosed in the prior art reads on the structural limitations of the claims of the present invention. Accordingly, prior art anticipates the claimed invention as presently construed.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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.
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
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