The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 10-29, are pending in this application.
Claims 1-9, are deleted.
Claim Rejections - 35 USC § 112
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 10-29, are rejected 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. The claim(s) 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 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.
The structures of IDO1 inhibitors, GCN2 inhibitors, CEBP inhibitors, CHOP, ATF4, AHR, mTOP, PKC, direct and indirect inhibitors of cytokine IL6, inhibitors of IL6 gene expression, inhibitors of IL6 gene protein production, inhibitors of IL6 gene cellular secretion, IL6 antibodies, siMRNA, antibody, antibody fragments, aptamers, small molecules, IDO1 inhibitors or ablators and their effective dosages, active agents, protein therapeutics nucleic acid molecules, molecules that inhibit or ablate IDO1 downstream signaling (claims 10-29), are not disclose in the claims. The claims invite a POSA to identify the applicable embodiments and make them using any means or procedure known to the artisan. Adding to the claims specific embodiments which have support in the specification, including enablements thereof, will overcome the rejection.
How to make eye drops, sprays, creams, ointments, gels, hydrogels, lenses, films implants, solutions, suspensions, colloidal systems, (claims 25, 29), eye active agent and how to make sustained release composition thereof (claim 28), are not disclosed in the claims. There is no incorporation-by-reference of US documents where the enablements can be found. To ascertain the steps, a POSA must read the specification and/or other external sources into the claims contrary to several precedent decisions by the US courts. Appropriate corrections are required.
There are no assays establishing nexus between IDO1 inhibitors and the claimed utilities. Therefore, claims are deemed speculations.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was filed to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 10-29, are rejected under 35 U.S.C. 103(a) as being unpatentable over Mautino et al. (WO 2012/142237 A1, in view of Soriano et al. (Graefes Arch. Clin. Exp. Ophthalmol., 2010, Vol. 248, pgs. 985-990, and Taylor et al. (FASEB J., 1991, Vol. 11, pgs. 2516-2522.
Mautino et al., teaches IDO inhibitors, derivatives thereof, and pharmaceutical compositions useful for modulating the activity of IDO and treating medical conditions that benefit from inhibition of IDO enzymatic activity, abstract, paragraph 0015. Mautino et al., teaches compounds, e.g.
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, 4-(2-(6-fluoro-5H-imidazo[5,1-a]isoindol-5-yl)-1-hydroxyethyl)cyclohexanol) or GDC-0919, pgs. 36, 183, #1371. The prior art teaches the compounds and pharmaceutical compositions thereof inhibit IDO, [0093]. They are useful for treating IDO mediated immunosuppression, and medical conditions that benefit from inhibition of IDO activity, abstract. Mautino et al., teaches combination therapy with other anti-cancer agents, anti-viral agents, or tyrosine kinase inhibitors, in a single dose administered simultaneously or dose administered sequentially, [0102]. Administration is by various routes, e.g. topical, ocular, oral, intravenous, insufflation or inhalation, intranasal, intravitreal injection, parenteral or ophthalmic administration. Intravitreal injection is used for treating age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, uveitis, endophthalmitis, retinitis or retinal detachment, Am Soc of Retina Specialists, https://www.asrs.org, visited 7/29/25.
The composition can be formulated as ointment, gel, cream, drops, quick sustained or delayed release, [0112], [0116]. Mautino et al., teaches the dosage depends on the disease or condition being treated, [0123]. Mautino et al., teaches ocular administration and treatment of age-related cataracts, [0101], but not other ocular diseases. However, the claims are still obvious in view of the following:
Soriano et al., teaches inflammatory processes are involved in the development of diabetic retinopathy, abstract. Soriano et al., teaches diabetic retinopathy is a progressive disease induced by chronic exposure to high blood glucose levels and is a recognized vascular disease, pg. 985, right col. The prior art teaches various therapies for diabetic retinopathy, including administration of anti-VEGF, anti-angiogenesis and anti-inflammatory agents, pg. 986, left col. The prior art teaches reports of animal models, and clinical studies, show that inflammation contributes to the development of diabetic retinopathy, and elevated levels of cytokines, IL-6, interferon-gamma (IFN-gamma) are found in diabetic retinopathy, pg. 986, left col. The prior art teaches significant increase in IL-2 and IFN-gamma concentrations are found in diabetic retinopathy rat model (pg. 988, left col, fig 2), and that the increase in inflammatory cytokines with elevated NO production supports the concept of inflammation in the development of diabetic retinopathy, pg. 989, left col. See the entire document, submitted in parent, US ’611.
Taylor et al., teaches IFN-gamma induces IDO, which is responsible for converting tryptophan and other indole derivatives to kynurenine, abstract. Taylor et al., teaches various animal studies show that after administration of interferon inducers, IDO induction is also observed, abstract. The prior art teaches various gene studies have shown that IDO is differentially regulated by IFN-gamma and thus suggests a possible role of IDO in inflammation. See the Abstract, submitted in parent, US ’611.
Having known as set forth above, it would have been obvious for a POSA to try inhibition of IDO in treating diabetic retinopathy (ocular disease) at the time the invention was made, with reasonable expectation of success, because Mautino et al., teaches IDO inhibitors are useful for treating IDO mediated immunosuppression, diseases mediated by IDO activity or age-related cataracts; teaches ocular administration, such as intravitreal injection, which is how age-related macular degeneration, diabetic retinopathy, retinal vein occlusion, uveitis, endophthalmitis, retinitis and retinal detachment are treated, Am Soc of Retina Specialists; the teaching by Soriano et al., that INF-gamma is increased in diabetic retinopathy; the teaching by Taylor et al., that INF-gamma induces increased levels of IDO activity.
The invention is obvious over the combination of the prior arts and knowledge known in the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 10-29, are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, of U.S. Patent No. 10,525,035, claims 1-15, of US11,376,236, and claims 1-21, US11,564,906. Although the claims at issue are not identical, they are not patentably distinct from each other because, the inventions in the patents, are claimed in the instant. The patents cite specific inhibitors, while in the instant the inhibitor is non-limiting.
Objection
The specification is objected because it has no paragraph numbers.
IDS
No IDS was filed in this application. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." See the MPEP 2000 and 37 CFR 1.97, 1.98. The references and English translations of all foreign documents must be submitted.
Comment
Instant claims were rejected in US16/739,948, NF; 16/697,611, NF, FR; and 15/533,201, NF.
This is a child of applicant's earlier Application No. 15/533,201, 16/697,611. All claims are identical to, patentably indistinct from, or have unity of invention with the invention claimed in the earlier application (that is, restriction (including lack of unity) would not be proper) and have been finally rejected on the grounds and art of record. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action in this case. See MPEP § 706.07(b). 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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Taofiq A. Solola, whose telephone number is (571) 272-0709.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor Andy Kosar, can be reached on (571) 272-0627. The fax phone number for this Group is (571) 273-8300.
Any inquiry of a general nature or relating to the status of this application or proceeding should be directed to the Group receptionist whose telephone number is (571) 272-1600.
/TAOFIQ A SOLOLA/Primary Examiner, Art Unit 1625
July 28, 2025