Prosecution Insights
Last updated: October 02, 2026
Application No. 18/263,293

TYK2 INHIBITOR COMPOUND CONTAINING BICYCLIC RING

Final Rejection §102§103§112
Filed
Jul 27, 2023
Priority
Feb 06, 2021 — CN 202110165856.4 +4 more
Examiner
LEE, CHIHYI NMN
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
OA Round
2 (Final)
34%
Grant Probability
At Risk
3-4
OA Rounds
4m
Est. Remaining
94%
With Interview

Examiner Intelligence

Grants only 34% of cases
34%
Career Allowance Rate
29 granted / 86 resolved
-26.3% vs TC avg
Strong +61% interview lift
Without
With
+60.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
77 currently pending
Career history
154
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
34.1%
-5.9% vs TC avg
§102
15.0%
-25.0% vs TC avg
§112
28.9%
-11.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 86 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION 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 . Election/Restrictions Applicant's election with traverse of Group I, drawn to a compound of formula I or a pharmaceutically acceptable salt thereof; and a compound 6-j having the structure of: PNG media_image1.png 59 61 media_image1.png Greyscale as the elected species of compound of formula I or a pharmaceutically acceptable salt thereof are maintained. Claims 3, 5 and 17-18 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Newly added claims 21 and 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Expansion of Election of Species Requirement A reasonable and comprehensive search of the elected species conducted by the Examiner discover a prior art by Liu et al. that renders obvious the claimed invention. In light of this discovery, the search is expanded to the subject matter of the subgenus of the elected compound species, i.e., the compounds of formula (I) having the structure of: PNG media_image2.png 50 61 media_image2.png Greyscale , in addition to the elected compound species (compound 6-j), such that it does not encompass the full scope of the claims. Status of the Claims Acknowledgement is made of the receipt and entry of the amendment to the claims filed on June 4, 2026, wherein claims 1, 3-5, 8, 10 and 11-15 are amended; claims 2, 6-7 and 9 are canceled; claims 16-18 are unchanged; and claims 19-24 are newly added. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action. Claims 1, 3-5, 8 and 10-24 are pending. Claims 3, 5 and 17-18 remain withdrawn. Claims 21 and 23-24 are withdrawn. Claims 1, 4, 8, 10-16, 19-20, and 22 are under examination in accordance with the elected invention and species along with the expanded compound species sets forth in the Expansion of Election of Species Requirement section above. Priority The instant application 18/263,293 filed on July 27, 2023 is a 371 of PCT/CN2022/075145 filed on January 30, 2022, which claims priority to, and the benefits of Foreign Application No. CN202110165856.4 filed on February 6, 2021, Foreign Application No. CN202110935764.X filed on August 16, 2021, Foreign Application No. CN202111063960.9 filed on September 10, 2021, and Foreign Application No. CN202210056272.8 filed on January 18, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Action Summary All rejections pertaining to claims 6-7 and 9 are moot because the claims were cancelled in view of the amendments filed on June 4, 2026. Claims 4, 8 and 10-14 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 are withdrawn in light of the claim amendments filed on June 4, 2026. Claims 1-2, 4, 6-9, 13-14 and 16 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) are withdrawn in light of the claim amendments filed on June 4, 2026. Specifically, the recitation of “3- to 10- membered heterocyclyl” is deleted from ring A. Claims 1-2, 4, 6-10 and 16 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) are withdrawn in light of the claim amendments filed on June 4, 2026. Specifically, the recitation of “3- to 10- membered heterocyclyl” is deleted from ring A. Claims 1-2, 4, 6-9 and 12-16 rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) are maintained, but revisited and modified in view of the claim amendments. Claims 1-2, 4 and 6-16 rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) as applied to claims 1-2, 4, 6-9 and 12-16 above, and further in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176) are maintained, but revisited and modified in view of the claim amendments. 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. Claims 1, 4, 8 and 12-16 remain rejected and claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) (partially newly applied as necessitated by amendment). Liu et al. teaches a compound of Example 55, 6-(cyclopropanecarboxamido)-4-((2-methoxy-3-(5-(tetrahydrofuran-3-yl) pyrimidin-2-yl) phenyl) amino)-N-(methyl-d3) pyridazine-3-carboxamide, having the structure of: PNG media_image3.png 55 60 media_image3.png Greyscale is an exemplary compound of formula I useful in the modulation of IL-12, IL-23 and/or IFN[Symbol font/0x61] (see e.g., p. 73, -line 5). Liu et al. further teaches a pharmaceutical composition comprising one or more compounds, which is, inter alia, 6-(cyclopropanecarboxamido)-4-((2-methoxy-3-(5-(tetrahydrofuran-3-yl) pyrimidin-2-yl) phenyl) amino)-N-(methyl-d3) pyridazine-3-carboxamide, and a pharmaceutically acceptable carrier or diluent (see e.g., claims 7 and 9). Liu et al. further teaches a compound of formula I PNG media_image4.png 185 184 media_image4.png Greyscale , wherein R3 is a 5-14 membered mono or bicyclic heterocycle containing 1-4 heteroatoms selected from N, O, and S, each group substituted with 0-4 R3a; R3a is independently at each occurrence, inter alia, a 5-14 membered mono or bicyclic heterocycle containing 1-4 heteroatoms selected from N, O, and S, each group substituted with 0-2 R3b; R3b is independently at each occurrence, F, OH, or C1-3 alkyl (see e.g., p. 7, line 1-line25). Liu et al. further teaches the term "heterocycle" includes “heteroaryl” groups (see e.g., p. 26, line 26-28); exemplary monocyclic heterocyclyl groups include, inter alia, tetrahydrofuranyl (see e.g., p. 27, line 1-7); and exemplary monocyclic heteroaryl groups include, inter alia, pyridyl and the like (see e.g., p. 27, line 25-27). Liu et al. further teaches in compounds of formula I, preferred heteroaryl groups include, inter alia, PNG media_image5.png 65 72 media_image5.png Greyscale , and the like, which optionally may be substituted at any available carbon or nitrogen atom (see e.g., p. 28, line 8-13). In the present case, the difference between the compound of Example 55 of Liu et al. and the claimed compound is that the prior art compound contains the tetrahydrofuranyl ring ( PNG media_image3.png 55 60 media_image3.png Greyscale ) rather than a pyridyl ring PNG media_image1.png 59 61 media_image1.png Greyscale shown below (see shaded): PNG media_image6.png 290 506 media_image6.png Greyscale . It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound of Example 55 of Liu et al., and then modify said compound by substituting the tetrahydrofuranyl ring with a pyridyl ring as the 5-14 membered mono or bicyclic heterocycle at R3a of the formula (I) taught by Liu et al. One would have been motivated to do so, because Liu et al. teaches R3a can be a 5-14 membered monocyclic heterocycle containing 1-4 heteroatoms selected from N, O, and S; the term "heterocycle" includes “heteroaryl” groups; and further teaches PNG media_image5.png 65 72 media_image5.png Greyscale is one of the preferred heteroaryl groups. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the compound of Example 55 of Liu et al. modified in accordance with the formula (I) taught by Liu et al. by substituting the tetrahydrofuranyl with a pyridyl ring would have successfully arrive at a compound of formula (I) that is similarly useful in the modulation of IL-12, IL-23 and/or IFN[Symbol font/0x61]; and therefore, said modified compound of Example 55 can successfully incorporate into a pharmaceutical composition without any appreciable loss of activity. Please note the modified compound of Example 55 of Liu et al. sets forth above is a compound having the structure of PNG media_image2.png 50 61 media_image2.png Greyscale , and that is a compound of formula I instantly claimed PNG media_image7.png 259 183 media_image7.png Greyscale , wherein X is N; q is 0; n is 0; T1 and T5 are N; T2, T3, and T4 are CH; ring A is PNG media_image2.png 50 61 media_image2.png Greyscale (6-membered heteroaryl); m is 0. Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed. Response to Arguments Applicant's arguments filed on June 4, 2026 with respect to the rejection of claims 1-2, 4, 6-9 and 12-16 under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) have been fully considered but they are not persuasive. All rejections pertaining to claims 2, 6-7 and 9 are moot because the claims were cancelled in view of the amendments filed on June 4, 2026. Applicant cancelled claims 2, 6-7 and 9, and newly added claims 19-24. Therefore, the rejection of record has been revisited and modified in view of the claim amendments. In Summary, Applicant argues the claimed invention specifically contains a 5- to 6-membered heteroaryl together with a pyrimidine ring as PNG media_image8.png 85 88 media_image8.png Greyscale demonstrate nanomolar activity by directing attention to Table 1 of instant specification. Applicant further argues the claim amendments filed on June 4, 2026 now requires a “5- to 6- membered heteroaryl” at Ring A of formula I; while Liu et al. discloses the pyrimidine ring can be substituted with an additional cyclic substituent (corresponding to Ring A of the claimed invention), the cyclic substituent of the exemplary compounds taught by Liu et al. (including Compounds 16, 27, 28, 31, 55, 112, 113, 116, and 117 of Liu et al.) are non-aromatic (hetero)cyclic ring rather than the claimed non-aromatic (hetero)cyclic substituents. Applicant further argues the term “heterocycle” defined by Liu et al. is broad, and the fact that exemplary compounds taught by Liu et al. contain non-aromatic (hetero)cyclic substituents rather than aromatic, one of ordinary skill in the art would have no reason to modify compound 55 of Liu et al. because saturated heterocyclic substituents and heteroaromatic substituents can differ substantially in their steric and electronic properties. Applicant further argues the examples of Liu et al. suggest that substituting a non-aromatic heterocyclic substituents for a heteroaryl substituent can lead to diminished biological activity, thus, one of ordinary skill in the art would have had no reason to modify the compound 55 of Liu et al. In response, applicant’s arguments are not found persuasive for the reasons set forth below: First, in response to applicant’s argument that the claimed invention demonstrates nanomolar inhibitory activity (IC50) in the STAT3 phosphorylation assay using Jurkat Cells (Experimental Example 2, Table 1). However, it is noted that the features upon which applicant relies (i.e., IC50 value in the STAT3 phosphorylation assay) are not recited in the rejected claim(s); therefore, the prior art does not need to teach the nanomolar activity that applicant relies upon. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). In response to applicant’s argument that non-aromatic heterocyclic substituents and heteroaryl substituents cannot be interchange, said argument is not found persuasive because the obviousness type rejection of record is form on the basis that Liu et al. provides teachings, suggestion or motivation to do so. Specifically, as noted in the rejection of record, Liu et al. clearly teaches R3a of formula I is “a 5-14 membered mono or bicyclic heterocycle containing 1-4 heteroatoms selected from N, O, and S, each group substituted with 0-4 R3b” (see e.g., claim 1), and provides a special definition for the term “heterocycle” to includes “heteroaryl” groups described therein (see e.g., p. 26, line 26-28); and further discloses that exemplary monocyclic heteroaryl groups embraced by the term “heteroaryl” includes, inter alia, pyridyl (see e.g., p. 27, line 25-27). In other words, in addition to incorporating the monocyclic heterocyclyl groups, such as tetrahydrofuranyl, as R3a, Liu et al. clearly provides teaching to include pyridyl as the alternated heterocycle ring to arrive at a compound of formula I. In response to applicant’s argument that the disclosure of Liu et al. is broad, said argument is not found persuasive. According to MPEP 2123, I, “[a] reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v.Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)”; and MPEP 2141.02, VI states: “‘the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…’ In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also MPEP § 2123”. Same logic is applicable to instant product claim(s), the mere fact that Liu et al. teaches other heteroaryl, other heterocycle, and other exemplary compounds of formula I, including those that do not contain an aromatic (hetero)cyclic substituent at R3a does not mean Liu et al. fails to teach pyridyl is an exemplary monocyclic heteroaryl group that can be include as the monocyclic heterocycle ring. The disclosure of more than one alternated heteroaryl, heterocycle and compound species of formula I does not constitute a teaching away, because such disclosure does not criticize, discrete, or otherwise discourage the incorporation of pyridyl as the monocyclic heterocycle at R3a to arrive at a compound of formula I with the same or substantially similar activity. In addition, it is respectfully noted that applicant repeatedly indicate none of the exemplary compounds taught by Liu et al. contains an aromatic heterocyclic ring as the R3a substituent to support the assertion that non-aromatic heterocyclic ring (e.g., tetrahydrofuranyl) and heteroaryl ring are not interchangeable, while indicating Liu et al. teaches compound 60 having the structure of: PNG media_image9.png 228 178 media_image9.png Greyscale in the reply (see e.g., page 37, last paragraph of the reply). Solely to rebut applicant’s argument that none of the exemplary compounds taught by Liu et al. contains an aromatic heterocyclic ring as R3a, the triazolyl ring contains in compound 60 of Liu et al. is clearly an aromatic heterocycle ring; and that provides a reasonable expectation of success for one of ordinary skill in the art to incorporate heteroaryl ring, including pyridyl and triazolyl, as the heterocycle at R3a of formula I. Given that a prior art reference must be considered in its entirety, the mere fact that Liu et al. fails to exemplify compound species with pyridyl at R3a does not mean the reference as a whole fails to suggest the incorporation of pyridyl. In response to applicant’s argument that substituting a non-aromatic heterocyclic substituent for a heteroaryl substituents can lead to diminished biological activity, said argument is not found percussive because the rejection of record does not rely on compound 60 of Liu et al. Solely to rebut applicant’s argument that compound 60 of Liu et al. has diminished biological activity, it may well be true that the compound 60 of Liu et al., which is the compound containing triazolyl as the aromatic heterocycle ring at R3a, has a hWB IC50 of 1.04 μM that is higher when compared to other exemplary compound species, such as Compound 57, 58 and 59 with a hWB IC50 of 0.117 μM, 0.267 μM and 0.121 μM, respectively(see e.g., p. 107-111 of Liu et al.). However, the mere fact that compound 60 of Liu et al. is not the best performing compound species of formula (I), it does not mean the compound 60 of Liu et al. or any compound species of formula (I) containing any heteroaryl ring at R3a is incapable of modulating IFN[Symbol font/0x61]. If applicant contends the incorporation of any heteroaryl at R3a of formula I losses the activity of modulating IFN[Symbol font/0x61], said objective evidence is respectfully requested. Therefore, the rejection of record is not found persuasive for the reasons set forth herein. Claims 1, 4, 8, 10-16 remain rejected and claims 19-20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) as applied to claims 1, 4, 8, 12-16 and 20 above, and further in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176) (partially newly applied as necessitated by amendment). The teachings of Liu et al. are sets forth above and applied as before. Liu et al. does not teach the elected compound species of Formula (I) having the structure of: PNG media_image1.png 59 61 media_image1.png Greyscale . Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical (see e.g., p. 3148-3149). Patani et al. further teaches nonclassical bioisosteric replacements of halogen, in which halogens have been replaced by electron-withdrawing groups such as a cyano or trifluoromethyl group, as exemplified below: PNG media_image10.png 465 571 media_image10.png Greyscale (see e.g., p. 3172, left column, “6. Halogen Bioisosteres” section, line 1-4; Figure 85 and Table 52). The difference between the modified compound of Example 55 of Liu et al. sets forth above and the claimed compound is that the modified compound contains the pyridyl ring that is unsubstituted rather than a pyridyl ring substituted with a trifluoromethyl group shown below (see shaded): PNG media_image11.png 294 522 media_image11.png Greyscale . It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the modified compound of Example 55 of Liu et al. sets forth above by substituting the pyridyl ring with a trifluoromethyl (-CF3) taught by Patani et al. One would have been motivated to do so, because Liu et al. teaches the 5-14 membered mono or bicyclic heterocycle at R3a can be substituted with 0-2 R3b selected from F, OH or C1-3 alkyl; and Patani et al. teaches halogens and trifluoromethyl (CF3) are non-classical bioisosteres in medicinal chemistry that can be interchanged to arrive at a compound with similar biological activity. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound of Example 55 of Liu et al. sets forth above substituted with a trifluoromethyl (-CF3) would have successfully arrive at a compound that is similarly useful in the modulation of IL-12, IL-23 and/or IFN[Symbol font/0x61]. Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed. Response to Arguments Applicant's arguments filed on June 4, 2026 with respect to the rejection of claims 1-2, 4 and 6-16 under 35 U.S.C. 103 as being unpatentable over Liu et al. (WO 2021/222153 A1; cited in the IDS filed on 7/27/2023) as applied to claims 1-2, 4, 6-9 and 12-16 above, and further in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176) have been fully considered but they are not persuasive. Applicant cancelled claims 2, 6-7 and 9, and newly added claims 19-24. Therefore, the rejection of record has been revisited and modified in view of the claim amendments. In Summary, applicant argues while bioisosterism can be used to rationally modify lead compounds, one of ordinary skill in the art would appreciate that the field of organic chemical synthesis can be highly unpredictable; therefore, while the incorporation of cyano or trifluoromethyl improved the activity of the compound in Figure 85 of Patani et al., it would not necessarily have the same effect for the claimed compounds of formula I. Applicant further argues Patani et al. teaches the incorporation of cyano and trifluoromethyl groups as bioisosteric replacements of halogens, not the incorporation of cyano and trifluoromethyl groups anywhere on the compound of Liu et al. In response, applicant’s arguments are not found persuasive for the reasons set forth herein: Frist, the obviousness-type rejection on the record is form using the combination of Liu et al. and Patani et al. to achieve the claimed invention, rather than Patani et al. alone to teach the modification of compound 55 of Liu et al. It is respectfully noted that the obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the rejection of record relies on Liu et al. to teach the 5-14 membered mono or bicyclic heterocycle at R3a can be substituted with 0-2 R3b, including F, at any position of the heterocycle (see e.g., p. 7, line 22); and further relies on Patani et al. to teach halogen and trifluoromethyl (CF3) are non-classical bioisosteres in medicinal chemistry that can be interchanged to arrive at a compound with similar biological activity. Accordingly, one of ordinary skill in the art would have reasonably expected that the R3b taught by Liu et al., i.e., halogen, interchanged with the halogen bioisosteres taught by Patani et al., including CF3, would successfully arrive at a compound with similar biological activity, in the absence of evidence to the contrary. In other words, the collective teachings of Liu et al. and Patani et al. together does not criticize, discrete, or otherwise discourage the incorporation of substituent(s), including CF3, at any position of the 5-14 membered mono or bicyclic heterocycle at R3a; therefore, applicant’s arguments that Patani et al. fails to teach trifluoromethyl groups can be added anywhere on the compound 55 of Liu et al. are not found persuasive. In response to applicant’s assertion that the bioisosteric replacement technique taught by Patani et al. does not necessarily arrive at compounds that elicit similar biological activity appears to be mere argument without objective evidence. According to MPEP 2143.02, “[c]onclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’"); Acorda Therapeutics, Inc. v. Roxane Lab., Inc., 903 F.3d 1310, 1333, 128 USPQ2d 1001, 1018 (Fed. Cir. 2018)”. In this case, the Examiner is not required to provide evidence demonstrating that the modification made to the compound of Example 55 of Liu et al. in view of Patani et al. gives absolute predictability. If applicant contends the compound of Example 55 of Liu et al. modified in view of Patni et al. loses the modulating activities taught by Liu et al., said objective evidence is respectfully requested. Therefore, the rejection of record is not found persuasive for the reasons set forth herein. Conclusion No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Chihyi Lee whose telephone number is (571)270-0663. The examiner can normally be reached Monday - Friday 8:30 am - 5:00 pm EST. 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, Amy L. Clark can be reached at (571) 272-1310. 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. /CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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Prosecution Timeline

Jul 27, 2023
Application Filed
Feb 04, 2026
Non-Final Rejection mailed — §102, §103, §112
Jun 04, 2026
Response Filed
Aug 10, 2026
Final Rejection mailed — §102, §103, §112 (current)

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3-4
Expected OA Rounds
34%
Grant Probability
94%
With Interview (+60.8%)
3y 6m (~4m remaining)
Median Time to Grant
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