CTNF 18/468,633 CTNF 97145 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia 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 Claims 1-20 are pending in the instant application. Priority This application claims priority to the provisional application 63407106 filed on 9/15/2022. Information Disclosure Statement The information disclosure statement (IDS) dated 4/15/2024 complies with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. Objections to the Claims Claim 1, line 5, lacks a comma. Please replace “or unsubstituted naphthyridinone or ” with “or unsubstituted naphthyridinone or, ”. Claim 1, line 7, lacks a comma. Please replace “or unsubstituted aryl or ” with “or unsubstituted aryl or, ”. Because written chemical names include commas, lists of chemical moieties should be delineated by semi-colons. For enhanced clarity, please add semi-colons between species within claims 6, 8, and 10. Claim 15 ends with a “/” instead of a period. Please replace “(XVII)/” with “(XVII).”. Claim 19 contains too many conjunctions. Please replace “the compound, or a pharmaceutically acceptable salt or a hydrate or a solvate thereof, of claim 1;” with “the compound of claim 1, or a pharmaceutically acceptable salt, hydrate, or solvate thereof;” Correction is required. See MPEP § 608.01(m). Claim Rejections – 35 USC § 112(b) 07-30-02 AIA 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. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention. 07-34-01 Claim 20 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 20 Claim 20 refers to a table. Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table “is permitted only in exceptional circumstances where there is no practical way to define the invention in words and w here it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience.” Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted). See MPEP § 2173.05(s). In the instant case, the chemical structures in Fig 6 could be easily incorporated into the claim without confusion. Double Patenting 08-33 AIA 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer. 18/468657 08-35 Claims 1-10, 12, 14, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/468657 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as described in the claim-by-claim analysis below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Regarding instant claim 1, the reference claims the identical oxazolyl structure (claim 7). Regarding instant claim 2, the reference claims the identical oxazolyl structure (claim 8). Regarding instant claim 3, the reference claims the identical naphthyridinone and dihydronaphthyridinone structures for variable T (claim 9). Regarding instant claim 4, the reference claims the identical naphthyridinone (claim 10). Regarding instant claim 5, the reference claims the identical variables for X (claim 11). Regarding instant claim 6, the reference claims the identical variables for X (claim 12). Regarding instant claim 7, the reference claims the identical variables for Z (claim 13). Regarding instant claim 8, the reference claims the identical variables for Z (claim 14). Regarding instant claim 9, the reference claims the identical formulas (claim 15). Regarding instant claim 10, the reference claims the identical species of formula (I) (claim 16). Regarding instant claim 12, the reference claims the identical exemplary species of formula (I) shown below (claim 17). PNG media_image1.png 200 400 media_image1.png Greyscale Regarding instant claim 14, the reference claims the identical formula (XVI) (claim 19). Regarding instant claim 20, the reference claims the identical Fig 6 (claim 20). 18/468639 08-35 Claims 1-11, 14, and 20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/468639 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other as described in the claim-by-claim analysis below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Regarding instant claim 1, the reference claims the identical oxazolyl structure (claim 7). Regarding instant claim 2, the reference claims the identical oxazolyl structure (claim 8). Regarding instant claim 3, the reference claims the identical naphthyridinone and dihydronaphthyridinone structures for variable T (claim 9). Regarding instant claim 4, the reference claims the identical naphthyridinone (claim 10). Regarding instant claim 5, the reference claims the identical variables for X (claim 11). Regarding instant claim 6, the reference claims the identical variables for X (claim 12). Regarding instant claim 7, the reference claims the identical variables for Z (claim 13). Regarding instant claim 8, the reference claims the identical variables for Z (claim 14). Regarding instant claim 9, the reference claims the identical formulas (claim 15). Regarding instant claim 10, the reference claims the identical species of formula (I) (claim 16). Regarding instant claim 11, the reference claims the identical exemplary species of formula (I) shown below (claim 17). PNG media_image2.png 200 400 media_image2.png Greyscale Regarding instant claim 14, the reference claims the identical formula (XVI) (claim 19). Regarding instant claim 20, the reference claims the identical Fig 6 (claim 20). Allowable Subject Matter 12-151-08 AIA 07-43 12-51-08 Claim s 13 are 15-19 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. Claim 1 The compounds of claim 1 were found allowable over the prior art. The closest prior art to the naphthyridinone/dihydronaphthyridinone substituted oxazolyl compounds of formula (I) are those of Duggan (US20100130540) who teaches naphthyridinone/dihydronaphthyridinone structures of formula (I) as a means of treating neurodegenerative diseases (pg 1, para 0003; pg 1, para 0007). PNG media_image3.png 194 411 media_image3.png Greyscale Importantly, Duggan does not teach or suggest attaching the naphthyridinone/dihydronaphthyridinone unit to the 4-position of the oxazole as instantly claimed. Duggan teaches other 5-membered heterocycles such as imidazole (shown below) and triazole being separated by methylene linker (pg 1, para 0012). PNG media_image4.png 270 371 media_image4.png Greyscale Absent a specific teaching to combine the naphthyridinone/dihydronaphthyridinone unit with a oxazole unit, whilst removing the methylene spacer, one of skill in the art would not have been motivated to generate the instantly claimed structures of formula (I). Dependent claims 2-13 and 19 which are drawn to more specific exemplary structures of Formula (I) and pharmaceutical compositions thereof are also rendered allowable. Claim 14 The compounds of claim 14 were found allowable over the prior art. The closest prior art to the pyrrolopyrimidinone, pyrrolopyridinone, furopyrimidinone and furopyridinone structures of formula (XVI) are those of Tamagnan (US20100143253). Tamagnan teaches structure of the formula below as a means of treating neurodegenerative diseases (pg 15, para 0062-0063). PNG media_image5.png 150 360 media_image5.png Greyscale Importantly, the structures of Tamagnan lack the 5-membered heterocycle being affixed to the 3-position of pyrimidinone unit, which is analogous to the 5-position of the pyridinone unit (as shown below). PNG media_image6.png 200 400 media_image6.png Greyscale Furthermore, of the fused heterocycles shown in Tamagnan’s formula above, all of them lack the carbonyl functionality of a pyrimidinone/pyridinone. Absent a specific teaching (i) to incorporate a carbonyl to generate a pyridinone/pyrimidinone species; and (ii) to incorporate a 5-membered heterocycle at the 3 or 5 position, one of skill in the art would not have been motivated to generate the instantly claimed compounds. Dependent claims 15-18 which are drawn to more specific exemplary structures of Formula (XVI) are also rendered allowable for the same reasons. Claim 20 Claim 20 is drawn to 821 distinctive species largely composed of the following structures (G1)-(G6), shown below. Structures of (G4) represented species of formula (I), discussed previously. Note: the short-hand structures drawn below depict greater breadth than what is claimed. Examiner does not assert that the genera of (G1)-(G6) shown below are also allowable. Examiner is merely using this as a means of organizing the discrete instantly claimed species. In other words, only the discretely claimed species described within Fig 6 were found allowable. PNG media_image7.png 200 400 media_image7.png Greyscale PNG media_image8.png 200 400 media_image8.png Greyscale These discrete chemical species of (G1)-(G6) described within Fig 6 were not found in the prior art. The closest prior art to (G1) is that of Inoue (US20090131413). Inoue teaches compounds of formula (I), shown below (pg 2, para 0014). PNG media_image9.png 190 224 media_image9.png Greyscale At best, Inoue teaches the following structure, which lacks the 4-fluoro group on the benzyl unit and attaches an N-linked (2,4-di-4-morpholinylphenyl) unit that was not featured in any of the compounds in Fig 6. PNG media_image10.png 256 352 media_image10.png Greyscale Absent a specific teaching to remove this dimorpholinyl unit and fluorinate the benzyl unit, one of skill in the art would not have been motivated to modify the structure of Inoue. The closest prior art to (G2)-(G3) is that of Molette (US20190071450), who teaches a structures of formula (I), shown below (pg 3, para 0025). PNG media_image11.png 124 405 media_image11.png Greyscale However, Molette fails to teach any exemplary species comprising the same heterocycle unit as (G2) and (G3), shown below (pg 5, para 0053). PNG media_image12.png 184 603 media_image12.png Greyscale Given the teachings of Molette, one of skill in the art would not have been motivated to add an additional heteroatom to the heterocycle that was not specifically taught in the reference. See also the structures of Honer ( doi: 10.2967/jnumed.117.196741 ), who teaches the following structures shown below (Fig 1), none of which were claimed in Fig 6. PNG media_image13.png 423 743 media_image13.png Greyscale The closest prior art to (G5)-(G6) is that of Chatzopoulou ( doi: 10.1039/c3cc45410j ) who teaches a method of generating 3-indole containing oxazoles (Table 2, shown below). PNG media_image14.png 206 849 media_image14.png Greyscale Because none of the compounds within Fig 6 featured an indole at 6-position of the oxazole, one of skill in the art would not have been motivated to remove this element, as it is critical for the synthesis to function (Table 2, shown below). PNG media_image15.png 277 799 media_image15.png Greyscale Absent a specific teaching to generate each of the specific species described in Fig 6, one of skill in the art would not have been motivated to synthesize the instantly claimed species. MPEP §2144.09 sets forth various considerations when considering compounds of close chemical structure, e.g., that successive addition of the same chemical group, such as additional CH2 groups, are generally expected to be so close that they possess the same or similar properties. However, while structural similarity is one consideration for obviousness, the evidence as a whole must be considered. In this case, there are large disparities between the chemical structures claimed and those in the prior art (e.g. completely different heterocycles and functional groups). As discussed above, absent a motivation to generate the instantly claimed compounds, one of skill in the art would not have found it obvious to generate them. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. 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If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /L.A.E./ Examiner, Art Unit 1675 /JEFFREY STUCKER/ Supervisory Patent Examiner, Art Unit 1675 Application/Control Number: 18/468,633 Page 2 Art Unit: 1675 Application/Control Number: 18/468,633 Page 3 Art Unit: 1675 Application/Control Number: 18/468,633 Page 4 Art Unit: 1675 Application/Control Number: 18/468,633 Page 5 Art Unit: 1675 Application/Control Number: 18/468,633 Page 6 Art Unit: 1675 Application/Control Number: 18/468,633 Page 7 Art Unit: 1675 Application/Control Number: 18/468,633 Page 8 Art Unit: 1675