CTFR 18/466,599 CTFR 88629 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 This office action is a response to Applicant’s amendments/remarks after non-final rejection filed 2/2/2026. As filed, claims 1, 3, 4, 7-11, and 13-21 are pending, wherein claim 21 is new; and claims 2, 5, 6, and 12 are cancelled. Priority The instant application is an application filed 9/13/2023, which claims the benefit under 35 USC 119 (e) from US Provisional Applications 63/406,099 filed 9/13/2022. With respect to the claim for the benefit of an effective U.S. filing date, it is noted that “the written description and drawing(s) (if any) of the provisional application must adequately support and enable the subject matter claimed in the nonprovisional application that claims the benefit of the provisional application. In New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290, 1294, 63 USPQ2d 1843, 1846 (Fed. Cir. 2002), the court held that for a nonprovisional application to be afforded the priority date of the provisional application, 'the specification of the provisional must contain a written description of the invention and the manner and process of making and using it, in such full, clear, concise, and exact terms' to enable an ordinarily skilled artisan to practice the invention claimed in the nonprovisional application" [MPEP 201.11A - emphasis in original]. It is noted that the requirement for support is evaluated for each claim individually such that different claims may be examined with different effective filing dates. In the instant case, the ‘099 provisional applications only provided support for the compound of instant formula (I) in claim 1, which means that claims 1, 3, 4, 7-11, and 13-20 are examined with an effective filing date of 9/13/2022 (the filing date of the ‘099 provisional application; i.e. earliest filing date). The compounds depicted in claim 21 are examined with an effective filing date of 9/13/2023 (the filing date of the instant application; i.e. earliest filing date) because the compounds depicted in claim 21 are not fully disclosed and supported by the ’099 provisional application. Should applicant desire that the benefit of an earlier effective filing date be according any of the instant claims, the claims must be amended such that they are fully supported by the ‘656 provisional application. Response to Amendments/Remarks Applicant’s amendments/remarks, filed 2/2/2026, with respect to claims 1-20, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below. The § 112(a) scope of enablement rejection of claims 16-20 is withdrawn per amendments. The § 102(a)(1) rejection of claims 1-20 by Kwong is withdrawn per cancellation of claims 2, 5, 6, and 12. Kwong is also removed as prior art because one of Applicants, Karl A. Scheidt, submitted a declaration under 37 CFR 1.130(a), which stated that Hannah E. Oelschlager, who is one of the co-authors of the Kwong reference, is working under the direction of the Applicants and did not contribute to the conception of the invention in the instant application (i.e. explaining the abovementioned co-author’s involvement, and the abovementioned co-author obtained the subject matter of the instant application from the Applicants). Because the publication date of the Kwong reference (i.e. 9/15/2021) is within the one year grace period from the effective filing date of the instant application (i.e. 9/13/2022 from the ‘099 provisional application), the filing of the abovementioned declaration disqualifies Kwong reference as prior art under 102(b)(1)(A) exception. The § 102(a)(1) rejection of claims 1-8, 11-13, and 15-20 by Kwong1 is withdrawn per amendment and cancellation of claims 2, 5, 6, and 12. However, the claims remains prima facie obvious over Kwong1. For details, see rejection below. The § 102(a)(1) rejection of claims 1-8, 11-13, and 15-20 by Scheidt is withdrawn per amendment and cancellation of claims 2, 5, 6, and 12. However, the claims remains prima facie obvious over Scheidt. For details, see rejection below. The nonstatutory obviousness-type double patenting (ODP) rejection of claim 2 by conflicting U.S. Patent No. 11,370,770 is withdrawn per cancellation of the claim. The nonstatutory obviousness-type double patenting (ODP) rejection of claims 1, 3 and 15-20 by conflicting U.S. Patent No. 11,370,770 (via anticipation analysis) is withdrawn per amendment. However, the claims remained prima facie obvious over conflicting U.S. Patent No. 11,370,770. For details, see rejection below. The nonstatutory obviousness-type double patenting (ODP) rejection of claims 4, 11, and 13 by conflicting U.S. Patent No. 11,370,770 (via obviousness-type analysis) is maintained because Applicant’s remarks are not persuasive. For details, see rejection below. The claim objection of claim 16 is withdrawn per amendments. Claim Rejections - 35 USC § 103 07-20 AIA 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 made 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. 07-23 AIA The factual inquiries set forth in Graham v. John Deere Co. , 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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. 07-21-02-aia AIA Claim s 1, 3, 4, 11, 13, and 15-20 are rejected under 35 U.S.C. 103 as being obvious over “Design, Synthesis, and Evaluation of MEK4 Inhibitors Against Metastatic Pancreatic Ductal Adenocarcinoma”, hereinafter Kwong1 . See IDS filed 12/5/2023 . . The applied reference has a common Applicant with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Regarding claims 1, 3, 4, 11, 13, and 15-20: Determining the scope and contents of the prior art: Kwong1, for instance, teaches the following compound or pharmaceutical composition thereof as MEK4 inhibitor for treating pancreatic ductal adenocarcinoma. The pharmaceutical composition is inherently made with a pharmaceutically acceptable carrier when the following compounds were tested for MEK4 inhibition. PNG media_image1.png 656 1026 media_image1.png Greyscale (II. Targeting MEK4 in PDAC) PNG media_image2.png 610 1084 media_image2.png Greyscale (VII. Bioisostere Inhibitors, Derivatives, and Future Directions, specifically PNG media_image3.png 210 378 media_image3.png Greyscale , wherein IC 50 : 42 nM) Ascertaining of the difference between the prior art and the claim at issue: In the abovementioned compound, Kwong1 did not explicitly teach the carboxyl substituent on the meta-position of the phenyl ring (see arrow below). PNG media_image4.png 210 378 media_image4.png Greyscale Finding of prima facie obviousness --- rationale and motivation: MPEP 2144.09.II. states, “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195USPQ 426 (CCPA 1977). The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds (i.e. positional isomer) would possess similar reactivity (i.e. they would be used as MEK4 inhibitors). Accordingly, one of ordinary skill would be motivated, from the disclosure in the prior art, to make the modifications required to arrive at the instant invention with reasonable expectation of success for obtaining a compound with the same utility. The motivation to make the change would be to make additional compound for the quoted purpose. In addition, there’s preferred embodiments (shown by box below) in Kwong1 that motivate a person of ordinary skill in the art to change from para- to meta-substitution on the phenyl ring. Thus, the instant claims are prima facie obvious. PNG media_image5.png 352 630 media_image5.png Greyscale 07-21-02-aia AIA Claim s 1, 3, 4, 11, 13, and 15-20 are rejected under 35 U.S.C. 103 as being obvious over U.S. Patent Application Publication No. 2020/0399241, hereinafter Scheidt . See PTO-892 form mailed on 10/2/2025 . The applied reference has a common applicant/assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02. Regarding claims 1, 3, 4, 11, 13, and 15-20: Determining the scope and contents of the prior art: Scheidt, for instance, teaches the following compounds or pharmaceutical composition thereof as MEK4 inhibitor for treating pancreatic cancer for treating pancreatic cancer. PNG media_image6.png 92 304 media_image6.png Greyscale (abstract) PNG media_image7.png 116 492 media_image7.png Greyscale (paragraph 0071) PNG media_image8.png 198 490 media_image8.png Greyscale (paragraph 0117) PNG media_image9.png 252 234 media_image9.png Greyscale (pg. 16, paragraph 0138) PNG media_image10.png 538 1216 media_image10.png Greyscale (Fig. 9) Ascertaining of the difference between the prior art and the claim at issue: In the abovementioned compound PNG media_image9.png 252 234 media_image9.png Greyscale , Scheidt did not explicitly teach the carboxyl substituent on the meta-position of the phenyl ring (see arrow below). PNG media_image4.png 210 378 media_image4.png Greyscale Finding of prima facie obviousness --- rationale and motivation: In the abovementioned compound PNG media_image9.png 252 234 media_image9.png Greyscale , MPEP 2144.09.II. states, “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195USPQ 426 (CCPA 1977). The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds (i.e. positional isomer) would possess similar reactivity (i.e. they would be used as MEK4 inhibitors). Accordingly, one of ordinary skill would be motivated, from the disclosure in the prior art, to make the modifications required to arrive at the instant invention with reasonable expectation of success for obtaining a compound with the same utility. The motivation to make the change would be to make additional compound for the quoted purpose. In addition, there’s preferred embodiments in Scheidt (shown below) that motivate a person of ordinary skill in the art to change from para- to meta-substitution on the phenyl ring. Thus, the instant claims are prima facie obvious. PNG media_image11.png 384 506 media_image11.png Greyscale (paragraph 0111) PNG media_image12.png 526 490 media_image12.png Greyscale (paragraph 0018) Nonstatutory 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp. The instant claims are drawn to a compound of instant formula (I), pharmaceutical composition thereof, or a method of treatment via the compound thereof. Claims 1, 3, 4, 11, 13, and 15-20 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below. If the conflicting claims are in a co-pending application , then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented. Co-pending Application No./ U.S. Patent No. Conflicting Claims Provisional ODP (Yes or No) 11,370,770 1, 2, and 4-13 No The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein. The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness. (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned U.S. patent are drawn to a compound of instant formula (I). (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned U.S. patent described the compound of instant formula (I) in a different Markush structure. (C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician. (D) Evaluate any objective indicia of nonobviousness - none Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other because they are drawn to the same compound having the same therapeutic utility (e.g. MEK4 inhibitor for treating cancer, etc.). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned U.S. patent. The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that the compounds of the abovementioned U.S. patent is excluded as the compound of instant formula (I) of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant process and that of the conflicting claims of the abovementioned U.S. patent to be equally effective in their objective. This rejection is in agreement with the judicially created doctrine grounded in public policy 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. Allowable Subject Matter 12-151-07 AIA 07-97 12-51-07 Claim 21 is allowed. 12-151-08 AIA 07-43 12-51-08 Claim s 7-10 and 14 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. Conclusion Claims 1, 3, 4, 11, 13, and 15-20 are rejected. Claims 7-10 and 14 are objected. 12-151-07 AIA 07-97 12-51-07 Claim 21 is allowed. Claims 2, 5, 6, and 12 are cancelled. 07-40 AIA 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. Telephone Inquiry Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm. 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, Clinton Brooks can be reached at (571)270-7682. 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. 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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. /PO-CHIH CHEN/Primary Examiner, Art Unit 1621 Application/Control Number: 18/466,599 Page 2 Art Unit: 1621 Application/Control Number: 18/466,599 Page 3 Art Unit: 1621 Application/Control Number: 18/466,599 Page 5 Art Unit: 1621 Application/Control Number: 18/466,599 Page 6 Art Unit: 1621 Application/Control Number: 18/466,599 Page 7 Art Unit: 1621 Application/Control Number: 18/466,599 Page 8 Art Unit: 1621 Application/Control Number: 18/466,599 Page 9 Art Unit: 1621 Application/Control Number: 18/466,599 Page 10 Art Unit: 1621 Application/Control Number: 18/466,599 Page 11 Art Unit: 1621 Application/Control Number: 18/466,599 Page 12 Art Unit: 1621 Application/Control Number: 18/466,599 Page 13 Art Unit: 1621 Application/Control Number: 18/466,599 Page 14 Art Unit: 1621 Application/Control Number: 18/466,599 Page 15 Art Unit: 1621 Application/Control Number: 18/466,599 Page 16 Art Unit: 1621 Application/Control Number: 18/466,599 Page 17 Art Unit: 1621 Application/Control Number: 18/466,599 Page 18 Art Unit: 1621
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