Prosecution Insights
Last updated: May 29, 2026
Application No. 17/605,369

MODULATORS OF THE INTEGRATED STRESS RESPONSE PATHWAY

Final Rejection §103§DOUBLEPATENT
Filed
Oct 21, 2021
Priority
Apr 23, 2019 — EU 19170502.9 +1 more
Examiner
MAHLUM, JONATHAN DAVIS
Art Unit
1625
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Evotec International GmbH
OA Round
4 (Final)
58%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
65%
With Interview

Examiner Intelligence

Grants 58% of resolved cases
58%
Career Allowance Rate
15 granted / 26 resolved
-2.3% vs TC avg
Moderate +7% lift
Without
With
+6.9%
Interview Lift
resolved cases with interview
Typical timeline
3y 9m
Avg Prosecution
43 currently pending
Career history
78
Total Applications
across all art units

Statute-Specific Performance

§101
1.5%
-38.5% vs TC avg
§103
44.3%
+4.3% vs TC avg
§102
16.8%
-23.2% vs TC avg
§112
1.5%
-38.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 26 resolved cases

Office Action

§103 §DOUBLEPATENT
Detailed Action The present office action is in response to the amendments filed on 16 Mar 2026. 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 . Status Claims 22, 29-32, 34-35, and 37-39 of the pending application have been examined on the merits. Claims 40-41 remain withdrawn. Acknowledgement is made of the amendments filed on 16 Mar 2026. Acknowledgement is made of the cancellation of claims 1-21, 23-28, 33, and 36. Priority The application retains the priority date of 23 Apr 2019. Response to Applicant Arguments Examiner acknowledges applicant arguments made in the reply filed 16 Mar 2026. The rejections of claim 33 are rendered moot following applicant amendments. Regarding the rejection of claims 22, 29-32, 34-35, and 37-39 under 35 U.S.C. § 103 over U.S. Patent No. 12,139,478, hereinafter ‘478, applicant's arguments filed 16 Mar 2026 have been fully considered but they are not persuasive. In pgs. 9-13 of the remarks filed 16 Mar 2026, applicant argues the present claims require both sides of the compounds of formula (I) to contain an aromatic ring. Applicant argues that '478 does not disclose any compounds within the scope of the present claims, especially any compounds where both sides of reference formula (I) have an aromatic ring. Applicant argues that the artisan would be motivated to pursue compounds that are structurally similar to the exemplified compounds, in particular those that are shown to be biologically active as seen in Tables 3 and 4 of '478, and those having a 3- or 4-membered fully saturated ring at the position corresponding to reference variable R3. Applicant argues there is no reason or motivation in '478 that would lead one of ordinary skill in the art to the compounds recited by the present claims. Applicant arguments are not a replacement for evidence (see MPEP § 2145(I)). As stated in the Office Action mailed 18 Dec 2025, '478 presents a broad claim scope which does not anticipate the elected claims. However, '478 does present all the elements necessary for a person having ordinary skill in the art to iterate using the elements present in the specification to obtain the instantly elected invention. Examiner agrees with applicant that the artisan would be motivated to pursue compounds that are structurally similar to the exemplified compounds in the reference, and would respectfully point applicant to compounds 54 and 55 of '478 as cited in the Office Action mailed 18 Dec 2025. '478 teaches that the 3- to 4-membered ring is not necessary for biological activity as seen by examples 23, 30, and 55 in Table 3. Thus the artisan would not necessarily only seek to experiment with compounds containing the 3- to 4-membered saturated ring structure. The artisan would further have all the elements necessary to obtain the instantly elected invention from the finite number of structural elements with a reasonable expectation of success. In light of the discussion above, the rejection of claims 22, 29-32, 34-35, and 37-38 under 35 U.S.C. § 103, as obvious over ‘478 is maintained for the reasons of record and restated below. Regarding the rejection of claims 22, 29-35, and 37-38 under 35 U.S.C. § 103 over WO 2020/181247 (provided in the office action mailed 12 Feb 2025), hereinafter ‘247, further in view of Patani et al. (Chem Rev, 1996, 96:3147-3176; provided in the office action mailed 12 Feb 2025), hereinafter Patani, Nirogi et al. (J Med Chem, 2018, 61:4993-5008; provided in the office action mailed 12 Feb 2025), hereinafter Nirogi, and Gleeson et al. (Nature Rev Drug Discov, 2011, 10:197-208; provided in the office action mailed 18 Dec 2025), hereinafter Gleeson, applicant arguments have been fully considered but are not persuasive. Applicant argues on pgs. 14-17 of the remarks filed 16 Mar 2026 that ‘247 has a different structural core as the instantly elected compound. Applicant further argues that ‘247 contains no motivation for modifying Ex. 29. Further, applicant argues that Patani contains at least 10 other options for bioisosteric modifications of hydrogen. Additionally, applicant argues that Patani contains at least 16 options to modify amide bonds in a bioisosteric manner. Applicant also argues that Nirogi shows moderation of potency occurs when replacing amide bonds with 1,3,4-oxadizaole moieties. Applicant finally argues that Gleeson underscores unpredictability rather than predictability. Applicant arguments are not a replacement for evidence (see MPEP § 2145(I)). The references teach the combined elements recited by the examined claims. ‘247 is relied on for teaching the species of Ex. 29. Patani is relied on for teaching that the artisan would have motivation and a reasonable expectation of success in modifying Ex. 29 by changing a hydrogen for a fluorine. Nirogi is relied on for teaching the motivation and expectation of success that the artisan would have in replacing an amide bond with a 1,3,4-oxadiazole moiety for Ex. 29. Gleeson is relied on for teaching that an expectation for success is not reliant only on potency for the medicinal chemist, but includes other factors such as ADMET properties. Absent a showing of unexpected results or further evidence, the references teach all the elements of the examined claims and the rejection is maintained. In light of the discussion above, the rejection of claims 22, 29-32, 34-35, and 37-38 under 35 U.S.C. § 103, as obvious over ‘247, Patani, Nirogi, and Gleeson is maintained for the reasons of record and restated below. Regarding the obviousness-type nonstatutory double patenting rejection of claims 22, 29-32, 34-35, and 37-39 over US Patent No 12,258,338, hereinafter ‘338, (formerly App No 17/605,037), further in view of Patani, applicant's arguments filed 16 Mar 2026 have been fully considered but are not persuasive. Applicant argues in pgs. 20-24 of the remarks filed 16 Mar 2026 that Patani must be evaluated for what it actually teaches a person of ordinary skill in the art to do to the specific structures at issue. Applicant argues that Patani when read in its entirety does not supply a teaching, suggestion, or motivation to make the particular cyclic atom modifications needed to convert the compound of ‘338 into the presently claimed compounds. Applicant further draws the attention to the differences found in the instant claims and the reference claims; specifically that the reference claims are drawn to a compound of the following formula: PNG media_image1.png 99 228 media_image1.png Greyscale Which does not share the structure as compounds of the instant claims. Applicant argues that the obviousness-type nonstatutory double-patenting rejection does not properly address the doctrine of nonstatutory double patenting since there are differences between the reference claims and the instant claims. Applicant further argues that the compounds in Patani are not structurally relevant to the compounds of ‘338 or the compounds recited in the present claims. Examiner respectfully directs applicant to MPEP § 804(II)(B) which states: 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 claims because the examined application claim(s) is either anticipated by, or would have been obvious over, the reference claim(s). In this case, the examined claims are not anticipated by the reference claims, which would require an anticipatory-type nonstatutory double-patenting rejection. However, the examined claims are obvious over the reference claims in view of Patani, resulting in an obviousness-type nonstatutory double-patenting rejection. MPEP § 804(II)(B)(3) provides guidance for nonstatutory double patenting rejections using an obviousness analysis which examiner has followed in the obviousness-type nonstatutory double patenting rejection found in the office action mailed 12 Feb 2025 and restated in the office action mailed 18 Dec 2025. Regarding applicant arguments against using Patani as a secondary reference for the obviousness-type double patenting rejection over ‘338, applicant has argued that the compounds in Patani are not structurally relevant to the instant claims or reference ‘338. However, the combined teachings of Patani and ‘338 render obvious the instant claims and the obviousness-type double-patenting rejection stands. App No 17/906,014 was issued a Notice of Allowance and is now U.S. Patent No. 12,441,720. The rejection is now directed to the patent and not the application and is no longer a provisional rejection. Regarding the obviousness-type nonstatutory double patenting rejection of claims 22, 29-35, and 37-39 over U.S. Patent No. 12,441,720, further in view of Patani, applicant's arguments filed 16 Mar 2026 have been fully considered but they are not persuasive. Applicant argues that the same reasoning applies for both obviousness-type rejections made over ‘338 and U.S. Patent No. 12,441,720. Applicant arguments are not persuasive for either rejection (see above). The obviousness-type double patenting rejections over U.S. Patent No. 12,258,338 and U.S. Patent No. 12,441,720, further in view of Patani, are maintained for the reasons of record and restated below. Claim Rejections - 35 USC § 103 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 (i.e., changing from AIA to pre-AIA ) 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. 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. Claim(s) 22, 29-32, 34-35, and 37-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 12,139,478, hereinafter ‘478. Regarding claims 22, 29-32, 34-35, and 37-38, ‘478 teaches small molecule modulators of eukaryotic initiation factor 2B (column 1, lines 15-20) including compounds of Formula (IIA) (column 26, line 5-12 and reference claim 2): PNG media_image2.png 81 253 media_image2.png Greyscale The instantly elected compound may be obtained when X1 is O; R3 is aryl substituted with two R11; R11 on R3 is independently halo; R4, R5, and R1 are H; ring A is heteroaryl ring; R2 is aryl substituted with one R11; R11 on R2 is halo; n is 0 and no R13 is present. However, ‘478 does not teach the instantly elected species: PNG media_image3.png 95 285 media_image3.png Greyscale ‘478 teaches compound 55 (column 61 and claim 38): PNG media_image4.png 108 266 media_image4.png Greyscale and shows that R3 can be a phenyl group (aryl); R11 can be F and Cl (halo) when attached to R3; R4, R5, and R1 can be H; X1 can be O; and ring A can be 1,3,4-oxadiazole (heteroaryl). ‘478 also teaches compound 54 (column 61 and claim 38): PNG media_image5.png 146 414 media_image5.png Greyscale and shows that R2 can be a phenyl group (aryl); and R11 can be Cl (halo) when attached to R2. It would be prima facie obvious to an ordinary person of skill in the art that the instantly elected species would have been obvious to try from a finite number of structural elements with a reasonable expectation of success. ‘478 presents a finite number of examples in the art which are useful as small molecule modulators of eukaryotic initiation factor 2B. Among those examples include all the structural elements necessary to construct the instantly elected species. One of ordinary skill in the art could have easily created different iterations of the examples proposed in ‘478 to obtain the instantly elected species with a reasonable expectation of success. Regarding claim 39, ‘478 teaches a pharmaceutical formulation of the reference compounds and a pharmaceutically acceptable excipient (claim 18). ‘478 additionally teaches that the compounds in the reference may be co-administered with another therapeutic agent to a subject (column 39, lines 4-6). A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary. Claim(s) 22, 29-32, 34-35, and 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘247 and further in view of Patani, Nirogi, and Gleeson. ‘247 teaches the compound Ex. 29 (pg. 47): PNG media_image6.png 80 271 media_image6.png Greyscale However, there are two differences between Ex. 29 and the instantly elected compound (circled in black below): Instantly elected compound Ex. 29 PNG media_image7.png 102 285 media_image7.png Greyscale PNG media_image8.png 88 271 media_image8.png Greyscale Ex. 29 teaches a hydrogen instead of the fluorine and an amide bond in place of the 1,3,4-oxadiazole in the instantly elected compound. Patani teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (pg. 3147). Patani further describes that bioisosteric replacements often provide the foundation for the development of quantitative structure-activity relationships associated with a specific class of drugs (pg. 3148, column 1). Patani teaches that the substitution of hydrogen by fluorine is one of the more commonly employed monovalent isosteric replacements (pg. 3149, column 1). Patani also teaches that the ability of fluorine to replace hydrogen is an effective method of exploring the affinity of an agent to the target site by virtue of its greater electronegativity while other parameters such as steric size and lipophilicity are maintained (pg. 3150, column 1). Furthermore, Patani teaches that heterocyclic rings such as 1,3,4-oxadiazoles have been used as replacements for amide or ester bonds (pg. 3170, column 1). Nirogi teaches the following compounds 4b and 4o (pg. 5000, Table 3): PNG media_image9.png 200 400 media_image9.png Greyscale PNG media_image10.png 200 400 media_image10.png Greyscale Where the amide bond of compound 4b has been replaced by oxadiazole in compound 4o. Oxadiazoles are known bioisosteres of amide bonds (pg. 4994, column 2 to pg. 4995, column 1). Compound 4o exhibited many of the same properties as compound 4b but had an increased bioavailability (pg. 4999, column 2 and Table 3). Nirogi concludes that compound 4o is a potent and selective 5-HT4R partial agonist with high oral exposures and good benetration and that further evaluation of compound 4o in additional efficacy-model, receptor mapping, and extended safety studies will be performed (pg. 5002, column 1). Gleeson teaches that a common assumption of drug discovery strategies is that compounds with high in vitro potency at their target(s) have greater potential to translate into successful, low dose therapeutics, but that the perceived benefit of high in vitro potency may be negated by poorer ADMET properties (Abstract). Gleeson teaches that the quest for high target potency should not be pursued blindly without an understanding of its relevance to efficacy and that there is a need to carefully consider what level of in vitro potency and selectivity is needed to achieve efficacy (pg. 207, column 1). Based on the teachings of ‘247, Patani, Nirogi, and Gleeson, a person of ordinary skill in the art would modify the compound taught in ‘247, Ex. 29, by replacing hydrogen with fluorine, as taught by Patani, and the amide bond with 1,3,4-oxadiazole, as taught by Nirogi, to arrive at the instantly elected compound. A person of ordinary skill in the art would have a reasonable expectation of success that these changes would retain the activity of Ex. 29 since fluorine is a known bioisostere for hydrogen and 1,3,4-oxadiazole is a known bioisostere for amide bonds. The artisan would be motivated to replace hydrogen with fluorine to explore the affinity of an agent to the target site while maintaining parameters such as steric size and lipophilicity, and would be motivated to replace the amide bond with oxadiazole to increase bioavailability. The artisan would consider any potency changes to be trade-offs while maximizing other parameters to create a compound with balanced ADMET properties, as taught in Gleeson. A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. 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 § 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. Claim(s) 22, 29-35, and 37-39 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. 12,258,338, hereinafter ‘338, in view of Patani. Regarding claims 22-25, 27, 29-35, and 37-38, ‘338 claims compounds of Formula (I): PNG media_image11.png 115 273 media_image11.png Greyscale One of the compounds created by Formula (I) is, for example, claimed in reference claim 26 as 2-(4-chloro-3-fluorophenoxy)-N-[(3S,6R)-6-[5-(4-chlorophenyl)-1,3,4-oxadiazol-2-yl]piperidin-3-yl]acetamide whose structure is found on pg. 128 of the reference application: PNG media_image12.png 64 172 media_image12.png Greyscale The example reference compound is created when X1 is N(Ra1); X1a is CH(Ra3); Ra1, R1, R2, R2a, Ra2, Ra3, Ra4, Ra5, Ra6, and Ra7 are H; R3 is A3; A3 is phenyl substituted with two R10; R10 is independently Cl and F (halogen); A1 is 1,3,4-oxadiazole (nitrogen ring atom containing 5-membered heterocyclene); A2 is A2a; A2a is phenyl substituted with one R6; and R6 is Cl (halogen). This structure almost overlaps with the instantly elected compound. However, the example reference compound contains a nitrogen for X1 instead of the required oxygen of the instant claims. Patani teaches that divalent isosteres can be classified into two groups, one of which is the divalent isosteres whose substitution results in the alteration of two single bonds such as C-C-C, C-NH-C, C-O-C, and C-S-C and that this type of bioisosteric substitution has been used extensively in the study of the structure-activity relationship of various pharmacologically active agents (pg. 3155, column 1). Patani also teaches that the bond angle or the conformation associated with the use of these divalent bioisosteres may be an important factor associated with retention of biological activity (pg. 3156, column 1). Patani teaches that a significant correlation between biological activity and electronegativity has been observed for these analogues (pg. 3156, column 1). It would be obvious to one having ordinary skill in the art to exchange the N of the reference generic claims for an O and arrive at compounds which overlap the instant generic claims because O is a classical divalent bioisostere of N and has been used extensively in the study of structure-activity relationships of pharmacologically active agents. A person having ordinary skill in the art would be motivated to make this change due to the increased electronegativity of O compared to N and the association with higher biological activity. Regarding claim 39, ‘338 claims in reference claim 60 a pharmaceutical composition comprising at least one compound or a pharmaceutically acceptable salt, solvate, hydrate, tautomer, or stereoisomer of claim 32 together with a pharmaceutically acceptable carrier, optionally in combination with one or more other bioactive compounds or pharmaceutical compositions. This is obvious over instant claim 39 when combined with the teachings of Patani (recited above). Claims 22, 29-35, and 37-39 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claim 1-23 of U.S. Patent No. 12,441,720 (formerly copending App No 17/906,014), hereinafter ‘720, in view of Patani. Regarding claims 22, 29-35, and 37-38, ‘720 claims compounds of Formula (I) (reference claim 1): PNG media_image13.png 118 259 media_image13.png Greyscale One of the compounds created by Formula (I) is, for example, claimed in reference claim 21 as 2-(4-chloro-3-fluorophenoxy)-N-[trans-2-[5-(4-chlorophenyl)-1,3,4-oxadiazol-2-yl]-1,3-dioxan-5-yl]acetamide which has the following structure (column 40): PNG media_image14.png 92 201 media_image14.png Greyscale The example reference compound is created when R1, R2, R2a, Ra1, Ra2, Ra3, Ra4, Ra5, and Ra6 are H; R3 is A3; A3 is phenyl substituted with two R10; R10 is independently F and Cl (halogen); A1 is 1,3,4-oxadiazole (nitrogen-containing 5-membered heterocyclene); A2 is A2a; A2a is phenyl substituted with one R6; and R6 is Cl (halogen). This structure almost overlaps with the instantly elected compound. However, the example reference compound contains an oxygen on the dioxane ring instead of the required carbon of the instant claims. Patani teaches that divalent isosteres can be classified into two groups, one of which is the divalent isosteres whose substitution results in the alteration of two single bonds such as C-C-C, C-NH-C, C-O-C, and C-S-C and that this type of bioisosteric substitution has been used extensively in the study of the structure-activity relationship of various pharmacologically active agents (pg. 3155, column 1). Patani also teaches that the bond angle or the conformation associated with the use of these divalent bioisosteres may be an important factor associated with retention of biological activity (pg. 3156, column 1). Patani teaches that a significant correlation between biological activity and electronegativity has been observed for these analogues (pg. 3156, column 1). It would be obvious to one having ordinary skill in the art to exchange the O of the reference generic claims for a C and arrive at compounds which overlap the instant generic claims because C is a classical divalent bioisostere of O and has been used extensively in the study of structure-activity relationships of pharmacologically active agents. A person having ordinary skill in the art would be motivated to make this change due to the decreased electronegativity of C compared to O and the association with a change in biological activity. Regarding claim 39, ‘720 claims in reference claim 23 a pharmaceutical composition comprising one or more compounds of the reference claims and a pharmaceutically acceptable carrier. This is obvious over instant claim 39 when combined with the teachings of Patani (recited above). Conclusion No claim is 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. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F. 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, 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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Prosecution Timeline

Show 2 earlier events
May 05, 2025
Response Filed
Jun 03, 2025
Final Rejection mailed — §103, §DOUBLEPATENT
Aug 28, 2025
Response after Non-Final Action
Oct 03, 2025
Request for Continued Examination
Oct 07, 2025
Response after Non-Final Action
Dec 18, 2025
Non-Final Rejection mailed — §103, §DOUBLEPATENT
Mar 16, 2026
Response Filed
Apr 24, 2026
Final Rejection mailed — §103, §DOUBLEPATENT (current)

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Prosecution Projections

5-6
Expected OA Rounds
58%
Grant Probability
65%
With Interview (+6.9%)
3y 9m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 26 resolved cases by this examiner. Grant probability derived from career allowance rate.

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