Prosecution Insights
Last updated: October 25, 2026
Application No. 18/032,098

SMALL MOLECULE MODULATORS OF GP130 SIGNALING PATHWAYS, TOPICAL FORMULATIONS AND METHOD OF USE THEREOF

Final Rejection §102§103§112§DOUBLEPATENT
Filed
Apr 14, 2023
Priority
Oct 16, 2020 — provisional 63/093,102 +2 more
Examiner
HIRAKIS, SOPHIA P
Art Unit
1623
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Carthronix Inc.
OA Round
2 (Final)
57%
Grant Probability
Moderate
3-4
OA Rounds
2m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 57% of resolved cases
57%
Career Allowance Rate
35 granted / 61 resolved
-2.6% vs TC avg
Strong +70% interview lift
Without
With
+69.8%
Interview Lift
resolved cases with interview
Typical timeline
3y 8m
Avg Prosecution
41 currently pending
Career history
98
Total Applications
across all art units

Statute-Specific Performance

§101
1.6%
-38.4% vs TC avg
§103
34.5%
-5.5% vs TC avg
§102
14.7%
-25.3% vs TC avg
§112
33.9%
-6.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 61 resolved cases

Office Action

§102 §103 §112 §DOUBLEPATENT
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 . Priority The instant application, filed 04/14/2023, is a 371 filing of PCT/US2021/055317, filed 05/15/2021, which claims domestic priority to U.S. provisional application numbers 63/093,140, and 63/093,102, both filed 10/16/2020. Amendments and Claim Status The following amendment filed on 08/19/2026 is acknowledged and entered. Claim 1 is amended; Claims 2-6, 10-12, 20, 29-42, 45, 46, and 48-60 are cancelled; Claims 15-19, 22-26, 28, 43, 44, and 47 were formerly withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. remain withdrawn according to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species; Claims 1, 7-9, 13-19, 22-26, 28, 43, 44, and 47 are pending and are under prosecution. Response to arguments Applicant’s arguments filed 08/19/2026 with respect to the objections to the specification, drawings, and claims as well as and claim rejections under 35 U.S.C. §§ 112(a), 112(b), 102 (a) (1 and 2), and 103 have been fully considered. With respect to the objection to the specification, the amendment to the specification filed a 08/19/2026 is hereby entered. However, the specification continues to list a long list of publications which attempt to incorporate subject matter by reference, and includes images of chemical compounds of insufficient resolution throughout the specification. The amendment is insufficient to overcome the objections. Accordingly, the objection to the specification is hereby maintained. With respect to the objection to the drawings, the amendment to the drawings filed a 08/19/2026 is hereby entered. However, Figures 4A/B continue to display different forms of data which are indistinguishable. There is no figure key or data labels to eight a person of ordinary skill in the art in understanding what the data displays. The amendment is insufficient to overcome the objection. Accordingly, the objection to the drawings is hereby maintained. With respect to the objection to claim 1, the amendment to the claim to remove the language of R2’ to R3’ is sufficient to overcome the objection on those grounds. However, the claim still continues to use low resolution images within the limitations of claim 1. The amendment is insufficient to overcome the objection. Accordingly, the objection to claim 1 is hereby maintained. With respect to the rejection of Claims 1, 2, 7-9, 13, 14, and 21 under 35 U.S.C. § 112(a) as failing to comply with the written description requirement, the amendment to claim 1 and cancellation of claims 2-6 is sufficient to overcome the rejection. Accordingly, the rejection is hereby withdrawn. With respect to the rejection of claims 1, 2, 7-9, 14, and 21 under 35 U.S.C. § 112(b) as being incomplete, the amendment to claim 1 and cancellation of claim 2 is insufficient to overcome the rejection because the claim continues to reflect a gap between the elements. Accordingly, the rejection hereby maintained, and applied to the claims which are currently pending. With respect to the rejection of claim 6 under 35 U.S.C. § 112(b) for references to tables in the claims, although the claim has been canceled, the limitations of the claim have now been imported into amended claim 1. As stated in MPEP § 2173.05 (s), claims should be complete to themselves and the reference to tables renders the claims incomplete. Accordingly, claim 1 is now rejected over the same grounds, and the rejection is hereby amended and maintained. With respect to the rejection of claim 6 under 35 U.S.C. § 112(d) as being of improper dependent form, the amendment of claim 1 and cancellation of claim 6 is sufficient to overcome the rejection. Accordingly, the rejection is hereby withdrawn. With respect to the rejection of claims 1, 2, 6-9, and 21 under 35 U.S.C. § 102 (a) (1) and (2) as being anticipated by Evenseenko (WO 2019169135 A1, published September 6, 2019) the claim amendments are insufficient to overcome the rejection. Claim 1 now recites a compound selected from a compound in the Tables 1 and 2, which include the elected species. Evenseenko explicitly anticipates the elected species, according to the previously filed rejection. The previously filed rejection is included hereinafter with amendments to include the pending claims. Accordingly, the rejection is hereby maintained. With respect to the rejection of claim 13 under 35 U.S.C. § 103 as being unpatentable over Evenseenko in view of Tsantoulas and McMahon (Trends Neurosci. Volume 37, Issue 3, pages 146–158, published January 21, 2014), the claim amendments are insufficient to overcome the rejection. Claim 1 now recites a compound selected from a compound in the Tables 1 and 2, which include the elected species. No additional arguments have been presented to rebut the teachings of Tsantoulas and McMahon. Accordingly, the rejection is hereby maintained. With respect to the rejection of Claim 14 under 35 U.S.C. § 103 as being unpatentable over Evenseenko in view of Sahil et al. (Int J Res Pharm Chem, Volume 1, Issue 4, pages 1184-1198, published 2011), hereinafter Sahil, the claim amendments are insufficient to overcome the rejection. Claim 1 now recites a compound selected from a compound in the Tables 1 and 2, which include the elected species. No additional arguments have been presented to rebut the teachings of Sahil. Accordingly, the rejection is hereby maintained. With respect to the rejection of claims 1, 2, 6-8, and 21 are on the ground of nonstatutory double patenting as being unpatentable over claim 15-19 copending Application No. 18/561,253 (US 20240279608 A1) and claims 1-19 of copending Application No. 18/858,121, (US 20250333423 A1), the claim amendments are insufficient to overcome the rejections. The co-pending applications define compounds which completely overlap in scope with the instantly claimed compounds, especially the elected species. The previously filed rejections are included hereinafter with amendments to include only the pending claims. Accordingly, the rejections are hereby maintained. With respect to the rejection of claims 1, 2, 6-9, 13, 14 and 21 on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 11,420,964 B2, the claim amendments are insufficient to overcome the rejections. The patented document defines compounds which completely overlap in scope with the instantly claimed compounds, especially the elected species. The previously filed rejection is included hereinafter with amendments to include only the pending claims. Accordingly, the rejection is hereby maintained. Status of Claims Claims 1, 7-9, 13-19, 22-26, 28, 43, 44, and 47 are pending in the instant application. Claims 15-19, 22-26, 28, 43, 44, and 47 remain withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1, 7-9, 13, 14, and 21 read on an elected invention and species and are therefore under consideration in the instant application. Specification The attempt to incorporate subject matter into this application by reference to define “scientific and technical terms… with meanings that are commonly understood by those of ordinary skill in the art” using a long list of references, for example in paragraphs [0042] and [0084], is ineffective because these publications have not been listed on an information disclosure statement, nor have copies of the publications been provided for the purposes of proper examination. Applicant is required to either amend the specification to specifically include the specific definitions to which the instant application is subject, or to provide the relevant passages from the reference publications within an information disclosure statement, and include them with the submissions of the instant application. Specification is objected to for including chemical structures of varying quality on pages 33-81. Applicant is respectfully asked to represent the chemical structures in a singular, consistent format of sufficient resolution and image quality. For example, compound A1 and A2 are of very different image quality, and compound A2 is warped as shown below: PNG media_image1.png 306 428 media_image1.png Greyscale Appropriate correction is required. Drawings The drawings filed on 08/19/2026 objected to under 37 CFR § 1.83(a) because they fail to show the data types as described in the instant specification. The different data types are indistinguishable in Figures 4A/B. The figures lack a figure key to describe the different data types. All data presented in different shades in the original drawings is now presented in black. There is no way for a person of ordinary skill in the art to ascertain what the different figure bars represent. The figures must be remade with a figure key or adequate labels describing the different types of data found in the figures. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Interpretation Claim 1 is subject to the following interpretation: The claim recites, wherein “a compound selected from a compound in Tables 1 and 2.” The claim is interpreted as encompassing all of the compounds found on pages 33-81 of the instant specification, including the elected species compound A10. Claim Objections PNG media_image2.png 179 266 media_image2.png Greyscale Claim 1 is objected to for the use of images of low resolution within the claim limitations. For example, in the substituent displayed (right) R22 and R23 are very difficult to distinguish due to the poor image quality used. Claim Rejections - 35 U.S.C. § 112 (b) 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. Claims 1, 7-9, 13, 14, and 21 are rejected under 35 U.S.C. § 112(b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements (see MPEP § 2172.01) More specifically, claim 1 recites, the following ring moieties: PNG media_image3.png 178 643 media_image3.png Greyscale as well as the following substituents : PNG media_image4.png 179 721 media_image4.png Greyscale However, the ring moieties and substituents recited within the claim do not relate to the recited “compound selected from a compound in Tables 1 and 2”. The elements omitted elements are the connecting features which would tie together the ring moieties and substituents to the compounds of the claims, which render claim 1 and all claims which depend on 1 incomplete. Claims 7-9, 13, 14, and 21 depend on claim 1 and do not remedy the incompleteness of claim 1, and are thus dually rejected as incomplete. Claims 1, 7-9, 13, 14, and 21 are rejected under 35 U.S.C. § 112(b) for references to tables in the claims. As stated in MPEP § 2173.05 (s), claims should be complete to themselves and the reference to tables renders the claims incomplete. Claims which recite figures or tables are only permitted in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference the duplicating a drawing or table into a claim. It is suggested to amend claim 6 to list all of the desired compounds to be claimed. Claims 7-9, 13, 14, and 21 depend on claim 1 and do not remedy the indefiniteness of claim 1, and are thus dually rejected as indefinite. Claim Rejections - 35 U.S.C. § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. § 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 1, 7-9, 13 and 21 are rejected under 35 U.S.C. § 102 (a)(1) and 102 (a)(2) as being anticipated by Evenseenko (WO 2019169135 A1, published September 6, 2019). The instant claims are drawn to a compound elected to be compound A10, and pharmaceutical composition thereof. Evenseenko teaches compositions and methods for modulating inflammatory and degenerative disorder (Title, paragraphs [0093] and [00120], see instant claims 7-9, and 21). Specifically, Evenseenko discloses CAS Registry Number: RN 457940-87-3. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 457940-87-3. Entered STN: 02 Oct 2002] (see Figure 2a below, and page 65, claim 5 column 2, row 3 of Evenseenko). Registry number 457940-87-3 is available as prior art as of 02 Oct 2002 (for the purposes of use as prior art under 35 U.S.C. § 102 (a)(1)), the date it was indexed into the REGISTRY database. Registry number 457940-87-3 anticipates compound A1, according to Formula (X) wherein: Figure 1. Comparison of the prior art compound with instantly claimed PNG media_image5.png 491 589 media_image5.png Greyscale Figure 1. a) CAS Registry Number: RN 457940-87-3 b) instantly claimed Formula (X); c) instantly claimed Formula (XA); d) instantly claimed Y; e) instantly claimed X; f) instantly claimed Z W is —N(R1)—, wherein R1 is H V is —C(O)— Y is as shown in Figure 2d, wherein Y1-Y3 are C, v is 0, R14, R15, R17, and R18 are H, and R16 is CH3 X is as shown in Figure 2e, wherein X1 is N, X2 is S, X3 is C, R2’ is absent, and R3’ is H Y3 are C, v is 0, R14, R15, R17, and R18 are H, and R16 is CH3 Z is as shown in Figure 2f, wherein Z5 is N, Z6-Z9 are C, R29-R32 are H, and R33 is absent Regarding claims 7, 8, and 21, Evenseenko teaches a pharmaceutical composition of compound A10 comprising a pharmaceutically acceptable carrier (claim 12). Regarding claim 9, Evenseenko teaches a pharmaceutical composition which dramatically inhibits Inflammation-induced degradation of cartilage matrix proteins (Figure 17). This is regarded as inherently treating inflammation and preventing joint degeneration. Regarding inherent properties, the courts have stated, In re Reynolds, 443 F.2d 384, 170 USPQ 94 (CCPA 1971); In re Smythe, 480 F. 2d 1376, 178 USPQ 279 (CCPA 1973); Yeda Research and Dev. Co. v. Abbott GMBH & Co., 837 F.3d 1341, 120 USPQ2d 1299 (Fed. Cir. 2016) ("Under the doctrine of inherent disclosure, when a specification describes an invention that has certain undisclosed yet inherent properties, that specification serves as adequate written description to support a subsequent patent application that explicitly recites the invention’s inherent properties." See MPEP § 2163.07 (a). Thus, all compounds within Formula (X) inherently share the same properties. Therefore, the compounds detailed by Evenseenko are inherently capable to be used for the purposes of treating inflammation and preventing joint degeneration, although not explicitly taught in the reference. Regarding claim 13, Evenseenko teaches that the compounds of the prior art may be further combined with a large range of therapeutic agents, including cancer immunotherapy monoclonal antibodies (paragraph [00100], see instant claim 13). See MPEP § 2128 “Printed Publications” as prior art. An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. § 102 (a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981): since this date represents the date that each compound entered the REGISTRY database on STN, this represents the date that each compound was made accessible to the public. It is further noted that for the purposes of determining if a reference is a “printed publication,” MPEP § 2128 (I) states the following: A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966)) ("We agree that ‘printed publication’ should be approached as a unitary concept. where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated. Claim Rejections - 35 U.S.C. § 103 The following is a quotation of pre-AIA 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. Claim 13 is rejected under 35 U.S.C. § 103 as being unpatentable over Evenseenko as applied to claims 1, 7-9, 13 and 21 above, and further in view of Tsantoulas and McMahon (Trends Neurosci. Volume 37, Issue 3, pages 146–158, published January 21, 2014). Claim 13 is drawn to a pharmaceutical composition of Formula (X), further comprising an additional therapeutic compound, elected to be a potassium channel activator. Evenseenko is as set forth above. Evenseenko fails to teach wherein the composition further comprises a potassium channel activator. The deficiencies of Evenseenko are remedied by Tsantoulas and McMahon, who teach that potassium channel activation is linked to inflammatory and mechanical pain phenotypes (Table 1). Specifically, the reference teaches potassium channel activators reduce inflammatory and mechanical pain by suppressing hyperexcitability of peripheral nociceptors (Kv7, BKCa, KATP, K2P, see Figure 2 of disclosure). Potassium channel activation polarizes sensory neurons, and limits pathological excitability that underlies inflammatory and mechanical pain. Finally, Tsantoulas and McMahon further disclose synergistic treatment strategies involvement potassium channel activators in combination with other drug classes to improve analgesic outcomes (page 185). Regarding claim 13, a person of ordinary skill in the art following the teachings of Tsantoulas and McMahon would have been motivated to combine potassium channel activators with the compounds disclosed by Evenseenko, which treat inflammation, because both of types of compounds are directed to a common purpose, i.e., treating inflammation. According to MPEP 2144.06 (I), combining equivalents known for the same purpose is rendered obvious. The courts have said, It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) Motivated by the explicit teaching of Tsantoulas and McMahon that synergistic combinations with other drug classes may improve analgesic outcomes, a person of ordinary skill in the art would have been directly motivated to combine potassium channel activators with compounds known to treat inflammation by Evenseenko, as they are both directed to treating inflammation, thus rendering the claims prima facie obvious. Claim 14 is rejected under 35 U.S.C. § 103 as being unpatentable over Evenseenko as applied to claims 1, 7-9, 13 and 21 above, and further in view of Sahil et al. (Int J Res Pharm Chem, Volume 1, Issue 4, pages 1184-1198, published 2011), hereinafter Sahil. Claim 14 is drawn to a pharmaceutical composition of Formula (X), further comprising microspheres, wherein the composition is formulated for slow-release delivery (see instant claim 14). Evenseenko is as set forth above. Evenseenko fails to teach wherein the composition further comprises microspheres, and wherein the composition is formulated for slow-release delivery. The deficiencies of Evenseenko are remedied by Sahil, who teaches the use of microspheres for delivering a therapeutic substance to a target site in a sustained-release controlled fashion (Abstract). Sahil reviews the various types of microspheres and the ways that drug efficacy is improved in a range of different conditions. Specifically teaches that inflammatory drug therapeutic efficacy has shown improvement upon use of controlled drug delivery and release systems Inc. microspheres (page 1188). Accordingly, a person of ordinary skill in the art, prior to the filing date of the instant claims, would have found it obvious to modify the pharmaceutical composition taught by Evenseenko to treat inflammation, to include microspheres for slow-release delivery, as taught by Sahil, in order to improve the efficacy of the pharmaceutical composition in treating inflammation. 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. Claims 1, 7-9, and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15-19 copending Application No. 18/561,253 (US 20240279608 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims define compounds which completely overlap in scope with the instantly claimed compounds, especially the elected species which is defined in claim 19 of the co-pending application (see page 57, column 2, row 1) This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/561,253, upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to a NSDP rejection over the published patent. Claims 1, 7-9, 13 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/858,121, (US 20250333423 A1). Although the claims at issue are not identical, they are not patentably distinct from each other because the co-pending claims define compounds which completely overlap in scope with the instantly claimed compounds, especially the elected species which is defined in claim 19 of the co-pending application (see co-pending specification, page 57, compound 6). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. If a notice of allowance is issued in the co-pending application 18/858,121, upon issue of the patent, the provisionary NSDP rejection over the co-pending application will convert to an NSDP rejection over the published patent. Claims 1, 7-9, 13, 14 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 11,420,964 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims define the compound that is the elected species (see claim 1) as well as a pharmaceutical composition thereof, further comprising an additional therapeutic agent which overlap with that of the instant claims (see claims 2-7). Conclusion No claims are allowed. Applicant's amendment necessitated the new grounds 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. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday. 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, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (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 +1 (800) 786-9199 (IN USA OR CANADA) or +1 (571) 272-1000. /SOPHIA P HIRAKIS/Examiner, Art Unit 1623 /VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
Read full office action

Prosecution Timeline

Apr 14, 2023
Application Filed
Feb 19, 2026
Non-Final Rejection mailed — §102, §103, §112
Aug 19, 2026
Response Filed
Oct 15, 2026
Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

3-4
Expected OA Rounds
57%
Grant Probability
99%
With Interview (+69.8%)
3y 8m (~2m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 61 resolved cases by this examiner. Grant probability derived from career allowance rate.

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