DETAILED ACTION
The Examiner inherited this application from another.
Notice of Pre-AIA or AIA Status
2. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
3. 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 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.
Continued Examination Under 37 CFR 1.114
4. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/01/2025, has been entered.
Current Status of 17,766,027
5. Amended claims 1, 2, 4-6, 8-10, 16, 18-20, 28 and 33 have been examined on the merits. Claims 1, 2, 4, 16 and 18 are currently amended. Claims 10, 19, 20, 28 and 33 are previously presented. Claims 3, 7, 11-15, 17, 21-27, 29-32 and 34-40 have been canceled.
Information Disclosure Statement
6. The information disclosure statement (IDS) and the supplemental Information Disclosure Statement under 37 CFR 1.56 submitted on 12/01/2025, were filed before the mailing of a first Office action after the filing of RCE. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
7. The Examiner acknowledges receipt of Applicants’ claim amendments and Reply
of December 1, 2025.
8. The Examiner has reviewed the claim amendments and Reply of 12/01/2025.
9. The claim rejection of claims 1-2, 4-6, 8-11 and 16-18 under 35 U.S.C. §102 against Registry 384361-40-2 is withdrawn in view of Applicants’ revising claim 1, wherein R8 is unsubstituted and substituted heteroaryl that no longer reads on the prior art.
10. The claim rejection of claims 1-2, 4-6, 8, 10-11, and 16-18 under 35 U.S.C. § 102(a) as being anticipated by Search Report on JP 2022-520582 is withdrawn. The search report was improper to cite as the reference, but the examiner disagrees with the characterization of the ISR. The ISR (237 and 210, 4/1/22) stated that US 2015/0344407 A1 anticipated and made obvious many claims. In combination with US 2009/0163476 A1, it made obvious additional claims. Upon further review, the examiner does not find this is supported.
11. The claim rejection of 1-2, 4, 6, 8, 10-11, 17, 19-20, 28, and 33 under 35 U.S.C. 103 is withdrawn in view of Applicants’ amending the claim with traverse, wherein R3 is C1-C₃ alkoxy, trifluoromethyl, trifluoromethoxy, trialkyl ammonium, pentafluorosulfanyl, halo, or-N(R¹⁰)(R¹¹) that no longer reads on the prior art. Applicants’ arguments are accepted and the rejection(s), including the references cited therein, are withdrawn.
Response to Amendment
Claim Rejections - 35 USC § 102
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.
12. Claim(s) 1, 2, 4-6 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ARUTYUNYAN (cited previously, PTO-892, 12/20/24).
ARUTYUNYAN teaches the following compound with a 2-furyl group as R8 in Formula I:
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Furan-2-ylmethyl-[3-(4-isopropoxyphenyl)-3-(2-methoxyphenyl) propyl]-amine (9) --- (see p. 378). This maps to instant claim 1 wherein: R1,R2, R4, R5, R7 and R9 are H; R3 is OMe; R6 is OPri and R8 is 2-furyl.
Thus, ARUTYUNYAN anticipates instant claims 1, 2, 4-6 and 8-9.
Claim 10 is drawn to an isomer (one of the two enantiomers in this case with one chiral center in the molecule) of a compound, ARUTYUNYAN teaches the ‘flat’ structure and embraces all isomers, and since there are so few alternatives, they are necessarily inherent. Thus, claim 10 is anticipated by ARUTYUNYAN.
Claim Rejections - 35 USC § 103
13. 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.
14. Claim(s) 1, 19-20, 28 and 33 are rejected under 35 U.S.C. §103 as being unpatentable over ARUTYUNYAN HANCOCK (US 20150344407A1. Referenced in IDS of 4/1/2022), in view of ARUTYUNYAN, further in view of MILBURN (US 200901 63476A1. Referenced in IDS of 4/1/2022), and TRUCILLO (Trucillo et al. “Drug Carriers: Classification, Administration, Release Profiles, and Industrial Approach” Processes 2021, 9, 470. Pub 3/6/2021)
Determining the scope and contents of the prior art
ARUTYUNYAN’s teachings on a compound of Formula I of claim 1 set forth above (¶ 12).
HANCOCK teaches a compound structurally closed to the instant compounds in the current application, a composition comprising the compound and a pharmaceutically acceptable carrier (para [0029], p 8; Claim 89) for treating pathogenic cellular proliferation (Claim 93, A method of treating a proliferative disorder, wherein the method comprises administering to a patient in need thereof a therapeutically effective amount of a compound of claim 1) and hyperproliferative disorder related cancers (para [0030], p 8), and/or a pathogenic vascular proliferative disease in a subject;
MILLBURN teaches sirtuin-modulating compounds and a composition comprising the pharmaceutically acceptable carrier of 2-hydroxypropyl-ß-cyclodextrin (para [0384], p 45), a combination with another therapeutic agent and a method for treating diseases or disorders related to aging or stress, diabetes, obesity, neurodegenerative diseases, cardiovascular disease, blood clotting disorders, inflammation, cancer, and/or flushing as well as diseases or disorders that would benefit from increased mitochondrial activity (see Abstract).
Ascertaining the differences between the prior art and the claims at issue
HANCOCK teaches a composition and method of treating proliferative disorder related diseases, including cancer with a compound structurally closed to the instant compounds in the current application (see two representative compounds below) and a composition comprising the compound and a pharmaceutically acceptable carrier (para [0029], p 8; Claim 89).
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Two representative compounds of HANCOCK (Table 1, p15)
HANCOCK doesn’t teach a compound of Formula I of the instant claim 1 or 2-hydroxypropyl-ß-cyclodextrin as a pharmaceutically acceptable carrier in particular, and fails to explicitly disclose wherein the ocular disease is selected from the group of eye diseases,
ARUTYUNYAN teaches instant compound 1.
MILLBURN teaches the common pharmaceutically acceptable carrier 2-hydroxypropyl-ß-cyclodextrin (para [0384], p 45).
Considering objective evidence present in the application indicating obviousness or nonobviousness
15. Regarding claim 19 directed to a composition comprising a compound of claim 1 and a pharmaceutically acceptable carrier, the artisan would be expected to add a carrier to the ARUTYUNYAN compound as HANCOCK shows it has several advantages of being safe and effective and may be administered to an individual without causing undesirable biological side effects or unwanted interactions (para [0140], p 36).
Furthermore, the artisan would be motivated to add a carrier to ARUTYUNAN compound because HANCOCK did it with a structurally similar active pharmaceutical ingredient and it produced greater stability, effectiveness, and less side effects, etc. These same benefits would be expected to translate to ARUTYUNAN compound since HANCOCK did not say the benefits of the carrier are specific only to its compound.
In addition, the artisan would be expected to add a carrier to ARUTYUNAN compound because TRUCILLO teaches drug carriers are biocompatible tools for the transport of molecules for pharmaceuticals that have the capability of incorporating a precise amount of molecules to enhance their selectivity, bioavailability, and efficiency (see Introduction, p 370).
Likewise, the artisan would be motivated to add a carrier to ARUTYUNAN compound as TRUCILLO teaches that the ability of drug carriers to enhance selectivity, bioavailability, and efficiency of molecules is applied to any pharmaceutical molecule, including, but not limited to, the ARUTYUNAN compound.
Therefore, claim 19 is obvious over HANCOCK in view of ARUTYUNYAN and TRUCILLO.
16. Regarding Claims 20 and 33 drawn to a pharmaceutical composition and a method for treating a condition/cancer comprising an effective amount of a compound of claim 1, HANCOCK discloses a pharmaceutical composition and a method for treating a condition/cancer, such as, but not limited to, breast cancer, colon cancer, etc. (para[0030], p8), but fails to explicitly disclose wherein the ocular disease is selected from the group consisting of age-related macular degeneration (AMD), diabetic retinopathy, retinopathy of prematurity, sickle cell retinopathy, retinal venous occlusive disease, central retinal vein occlusion (CRVO), branch retinal vein occlusion (BRVO), neovascular macular degeneration or an ocular cancer. Milburn teaches wherein the ocular disease is selected from the group consisting of age-related macular degeneration (AMD) (paras. [0279] - [0281] and [0287] - [0288], Exemplary retinal diseases include Exudative Age Related Macular Degeneration, pgs. 33-34). It would have been obvious to an artisan to modify HANCOCK with the teaching of Milburn for being used for a variety of therapeutic applications including, for example, increasing cellular sensitivity to stress, increasing apoptosis, treatment of cancer, etc. (para [0025] p 2). Thus, claims 20 and 33 are obvious over HANCOCK in view of ARUTYUNYAN and further in view of MILBURN.
17. Regarding Claim 28 further reciting a pharmaceutical composition of claim 20 comprising 2-hydroxypropyl-ß-cyclodextrin, the artisan would be expected to add 2-hydroxypropyl-ß-cyclodextrin to the ARUTYUNYAN compound as MILLBURN teaches a pharmaceutical composition comprising the pharmaceutically acceptable carrier of 2-hydroxypropyl-ß-cyclodextrin (para [0384], p 45). The artisan would be motivated to add 2-hydroxypropyl-ß-cyclodextrin to the ARUTYUNYAN compound since MILLBURN further teaches one way to produce a formulation, particularly a solution is through the use of cyclodextrins (including, but not limited to, 2-hydroxypropyl-ß-cyclodextrin) to form inclusion complexes with any drug whose molecule can fit into the lipophile-seeking cavities of the cyclodextrin molecule (para[0382], p 45), and use of cyclodextrin for solubilizing compounds (para[0388], p 46).
Accordingly, claim 28 is obvious over HANCOCK in view of ARUTYUNYAN and further in view of MILBURN.
Allowable Subject Matter
18. Claims 16 and 18 are free of the prior art. The examiner conducted a broader STN search of the compound in claim 10 by substituting Cl with an X (halide) (see Search 6 of the attached search notes) and retrieved only the present application. The two compounds were registered in STN both on April 28, 2021, which is later than the domestic benefit date of the current application of October 1, 2019 thus making claims 16 and 18 are free of the prior arts.
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Conclusion
19. Claims 16 and 18 are free of the prior art.
20. Claims 16 and 18 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.
21. Claims 1, 2, 4-6, 8-10, 19-20, 28 and 33 are rejected.
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/B.T./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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