Prosecution Insights
Last updated: April 19, 2026
Application No. 18/561,111

PHARMACEUTICALLY ACCEPTABLE SALT OF PYRAZOLOHETEROARYL DERIVATIVE AND CRYSTAL FORM THEREOF

Non-Final OA §102§103§112§DP
Filed
Nov 15, 2023
Examiner
RAO, PADMAJA S
Art Unit
1627
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Shanghai Hengrui Pharmaceutical Co. Ltd.
OA Round
1 (Non-Final)
71%
Grant Probability
Favorable
1-2
OA Rounds
2y 8m
To Grant
99%
With Interview

Examiner Intelligence

Grants 71% — above average
71%
Career Allow Rate
84 granted / 118 resolved
+11.2% vs TC avg
Strong +40% interview lift
Without
With
+40.4%
Interview Lift
resolved cases with interview
Typical timeline
2y 8m
Avg Prosecution
61 currently pending
Career history
179
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
32.8%
-7.2% vs TC avg
§102
17.2%
-22.8% vs TC avg
§112
25.2%
-14.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 118 resolved cases

Office Action

§102 §103 §112 §DP
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. Status of Claims Claims 1, 7, 12, 14-29 are pending in the application as of the preliminary amendment submitted 11/15/2023 . Claims 2-6, 8-11, 13 are cancelled. Claims 19-29 are newly added. Claims 1, 7, 12, 14-29 are examined herein. Priority This application is a 371 of PCT/CN2022/094161 filed 05/20/2022 and claims foreign priority to CHINA 202110558670.5 filed 05/21/2021. It is noted that Applicants have not provided an English translation of the certified copy of the foreign priority application as required by 35 U.S.C. 119(b). Without the English translation, one cannot ascertain if the instant invention is supported in the Chinese application. Therefore, art prior to the PCT date, but not before the date of the Chinese application may be cited against the claims. Accordingly, claims 1, 7, 12, 14-29 have been afforded an effective filing date of 05/20/2022 , the filing date of the PCT application . Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application. Information Disclosure Statement The information disclosure statements filed on 12/30/2024 and 11/15/2023 have been considered. The submissions are in compliance with the provisions of 37 CFR 1.97. Claim Rejections - 35 USC § 112 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 27-29 are 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. Regarding claims 27-29, the claim s recite “the method comprising administering to the subject the pharmaceutical composition according to claim 19”. However, claim 19 is drawn to a pharmaceutically acceptable salt of a compound of formula (I). There is insufficient antecedent basis for the limitation “the pharmaceutical composition according to claim 19” in the claims. For the purpose of applying prior art, claims 27-29 have been interpreted to read “ the pharmaceutical composition according to claim 22” to provide sufficient antecedent basis. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(d): (d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph: Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers. Claims 17-18 and 20-21 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Regarding claims 17-18, the claims recite “the method comprising administering to the subject the compound of formula (I) according to claim 1”. This broadens the scope of dependent claims 17-18 since claim 1 is drawn to a pharmaceutically acceptable salt of a compound of formula (I), which is improper. Regarding claim 20, the claim depends from claim 7 and recites “the crystalline form I of maleate of a compound of formula (1) of claim 7, has an X-ray powder diffraction pattern with characteristic peaks …”. “Form I of maleate of a compound of formula (1)” is the most specific recitation of a solid form and will inherently exhibit the recited X-ray powder diffraction peaks of the dependent claim 20. This is not considered as further limiting the scope of claim 1, which is improper. Regarding claim 21, the claim depends from claim 7 and recites “the crystalline form I of maleate of a compound of formula (1) of claim 7, has an X-ray powder diffraction pattern shown in FIG. 8 …”. “Form I of maleate of a compound of formula (1)” is the most specific recitation of a solid form and will inherently exhibit the recited X-ray powder diffraction pattern of FIG. 8. This is not considered as further limiting the scope of claim 1, which is improper. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. It is suggested that Applicants amend to remove the specific recitation of form I in the claims, to overcome this rejection. Claim Rejections - 35 USC § 102 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 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 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, 14-19 and 22-29 are rejected under 35 U.S.C. 102(a)(1)/35 U.S.C. 102(a)(2) as being anticipated by Li et al. (AU 2020386587 A1, publication date 27 May 2021, international filing date 20 November 2020, hereinafter Li). The Li et al. reference (with common Applicant and different inventive entity) is an equivalent of WO 2021/098811 A1, in the IDS. The AU patent document is used for cleaner English translation with structures. Regarding instant claims 1 and 19 , Li teaches a pyrazolo-heteroaryl derivative of general formula (I) or a pharmaceutically acceptable salt thereof, a preparation method therefor, a pharmaceutical composition containing the derivative, and a use thereof as a therapeutic agent, particularly as ATR kinase inhibitor and in the preparation of drugs for the treatment and/or prevention of hyperproliferative diseases (Abstract). Li teaches an exemplary compound, of example 1, shown below (Pg. 4, first compound), that anticipates a compound of formula (I) of instant claim 1. Li teaches reagents that provide acidic conditions in the synthesis schemes to include formic acid, acetic acid, hydrochloric acid, sulfuric acid, methanesulfonic acid, phosphoric acid and p- toluenesulfonic acid. This would lead to the formation of the respective salts, say, hydrochloride, sulfate, mesylate, phosphate, p - toluenesulfonate . Therefore, the teachings of Li anticipate the limitations of instant claim 1 and 19 drawn to a pharmaceutically acceptable salt of a compound of formula (I). Li teaches a pharmaceutical composition comprising the compound of formula (I), or the pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carrier, diluent or excipient (Pg. 16, first full paragraph). Li teaches oral compositions prepared by any known method and includes mixing the active ingredient with a non-toxic pharmaceutically acceptable excipient (Pg. 18, fourth paragraph). Li teaches preparing various other compositions by mixing the active substance with an excipient (Pg. 18, fifth paragraph – Pg. 19, fourth full paragraph). Li teaches a method for inhibiting ATR kinase, comprising: administering to a patient in need an effective amount of the compound of formula (I), or the pharmaceutically acceptable salt thereof, or the pharmaceutical composition comprising the same (Pg. 17, first full paragraph). Li teaches a method for treating and/or preventing a hyperproliferative disease, comprising: administering to a patient in need an effective amount of the compound of formula (I), or the pharmaceutically acceptable salt thereof, or the pharmaceutical composition comprising the same (Pg. 17, second full paragraph). Li teaches a method for treating and/or preventing a tumor, comprising: administering to a patient in need an effective amount of the compound of formula (I), or the pharmaceutically acceptable salt thereof, or the pharmaceutical composition comprising the same (Pg. 17, third full paragraph). According to MPEP 2131.02(III), “A GENERIC DISCLOSURE WILL ANTICIPATE A CLAIMED SPECIES COVERED BY THAT DISCLOSURE WHEN THE SPECIES CAN BE "AT ONCE ENVISAGED" FROM THE DISCLOSURE”. A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[ oes ] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." Kennametal, Inc. v. Ingersoll Cutting Tool Co ., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) (quoting In re Petering , 301 F.2d 676, 681(CCPA 1962)). In the instant case, a pharmaceutically acceptable salt of a compound of formula (I) as in instant claims 1 and 19 ; a pharmaceutical composition as in instant claims 14 and 22 ; a method of preparing a pharmaceutical composition as in instant claims 15 and 23 ; a method for inhibiting ATR kinase, a method for treating a hyperproliferative disease, a method for treating a tumor as in instant claims 16-18 and 24-29 , can be clearly envisaged by a person of ordinary skill in the art, given the disclosure of Li. Applicants may overcome this rejection under 35 U.S.C. 102(a)(1)/35 U.S.C. 102(a)(2) 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 MPEP 717.02. Claim Rejections - 35 USC § 103 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, 14-19 and 22-29 are rejected under 35 U.S.C. 103 as being unpatentable over Burgdorf et al. (WO 2020/049017 A1, 12 March 2020, hereinafter Burgdorf , in the IDS) in view of Fleming et al. (Nitrile-Containing Pharmaceuticals: Efficacious Roles of the Nitrile Pharmacophore, 30 August 2010, hereinafter Fleming). Regarding instant claim 1 and 19 , Burgdorf teaches 5-morpholin-4-yl-pyrazolo[4,3-b]pyridine derivatives as inhibitors of ATR used in the treatment of cancer (Title; Abstract; Pg. 1, Lns . 5-12). Burgdorf teaches pharmaceutically acceptable salts thereof having valuable pharmaceutical properties (Pg. 3, Lns . 10-12; Pg. 4, Ln. 10 - Pg. 5, Ln. 20; Pg. 14, Ln. 10-15). Burgdorf teaches the salts to include acid-addition salts of organic and inorganic acids, such as hydrogen chloride, hydrogen bromide, sulfate, phosphate, … alkyl- and monoarylsulfonates , such as toluenesulfonate , … acetate, maleate , succinate, citrate, … malate, … methanesulfonate (i.e., mesylate) , …oxalate, etc.. (Pg. 15, Lns . 1-15). Burgdorf teaches an exemplary compound of example 25, shown below (Pg. 94, Lns . 12-20). 1352550 796290 0 0 Example 25 of Burgdorf overlaps the scope of a compound of formula (I) of instant claim 1, differing only in the presence of a hydroxyl group in place of the instantly claimed nitrile group. Burgdorf teaches optimizing pharmacokinetic parameters by effecting suitable modifications, such as deuteration, as one strategy to enhance metabolic stability when developing therapeutic agents (Pg. 19, Ln. 1 – Pg. 20, Ln. 8). Fleming teaches nitrile-containing compounds as an important pharmacophore in pharmaceuticals (Pg. 7902, first column, first paragraph). Fleming teaches the nitrile group to be robust and not readily metabolized, including nitriles attached to fully substituted carbons (Pg. 7902, first column, third paragraph – second column, continued paragraph). Fleming teaches nitriles play a key role as hydrogen bond acceptors and the strong dipole facilitates polar interactions in which the nitrile acts as a hydroxyl or carboxyl isostere (Pg. 7902, second column, third full paragraph). Fleming teaches α-aryl acetonitrile drugs contain the nitrile on a quaternary carbon adjacent to an aromatic ring (Pg. 7906, second column, last paragraph; Figure 14). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in view of the teachings of Burgdorf and Fleming to have replaced the hydroxyl group of example 25 of Burgdorf , with a nitrile group, as taught by Fleming, to arrive at the pharmaceutically acceptable salts of the instant invention with a reasonable expectation of success. Burgdorf teaches 5-morpholin-4-yl-pyrazolo[4,3-b]pyridine derivatives and pharmaceutically acceptable salt thereof, as inhibitors of ATR . Burgdorf teaches the salts to include acid-addition salts of organic and inorganic acids, such as hydrogen chloride, hydrogen bromide, sulfate, phosphate, toluenesulfonate , acetate, maleate, succinate, citrate, malate, methanesulfonate , oxalate. Burgdorf teaches an exemplary compound with close structural similarity to the instant compounds having a hydroxy group in place of the nitrile group. Burgdorf teaches optimizing pharmacokinetic parameters by effecting suitable modifications, as a common strategy to enhance metabolic stability when developing therapeutic agents. Fleming teaches nitrile-containing compounds as an important pharmacophore in pharmaceuticals. Fleming teaches nitriles play a key role as hydrogen bond acceptors and the strong dipole facilitates polar interactions in which the nitrile acts as a hydroxyl isostere. According to MPEP 2144.09 (I), A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne , 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). In the instant case, the 5-morpholin-4-yl-pyrazolo[4,3-b]pyridine derivatives of Burgdorf and the instant compounds, with close structural similarity, have the same utility - inhibitors of ATR . Therefore, one of ordinary skill in the art would have been motivated to replace the hydroxyl group of the compounds of Burgdorf with a nitrile group, as taught by Fleming, to arrive at the instantly claimed pharmaceutically acceptable salts. The motivation being for lead optimization of drug leads by incorporating the versatile functionality of nitriles, thereby modulating its metabolic stability (Fleming, Pg. 7902, second column, second full paragraph; Pg. 7903 , first column, continued paragraph). Thus the teachings of Burgdorf in view of Fleming render the pharmaceutically acceptable salt of a compound of formula (I) as in instant claim 1 and 19, prima facie obvious. Regarding instant claim 14-15, 22-23 , the combined teachings of Burgdorf and Fleming render the pharmaceutically acceptable salt of a compound of formula (I) as in instant claim 1, prima facie obvious. Burgdorf teaches pharmaceutical formulations comprising the pharmaceutically acceptable salt and a suitable carrier or excipent in various embodiments (Pg. 21, Ln. 4 – Pg. 26, Ln. 15). Burgdorf teaches preparation of formulations for oral administration by comminuting the compound of interest and mixing it with a pharmaceutical excipient comminuted in a similar manner (Pg. 22, Lns . 2-8). Regarding instant claim 16-18, 24-26, 27-29 , the combined teachings of Burgdorf and Fleming render the pharmaceutically acceptable salt of a compound of formula (I) as in instant claim 1, prima facie obvious. Burgdorf teaches methods of treating diseases utilizing pharmaceutical compositions comprising these compounds (Pg. 1, Lns . 8-10). Burgdorf teaches the compounds, including pharmaceutically acceptable salts being suitable as pharmaceutical active ingredients in the treatment of cancer (Pg. 28, Lns . 20 – Pg. 29, Ln. 5). Burgdorf teaches use of the pharmaceutically acceptable salts in the treatment of an ATR-induced disease in a mammal by administering a therapeutically effective amount to the sick animal in need of treatment (Pg. 29, Lns . 6-12). Burgdorf teaches use of the pharmaceutically acceptable salts for the inhibition of ATR (Pg. 29, Lns . 17-20). Burgdorf teaches use of the pharmaceutically acceptable salts in the treatment of various tumors (Pg. 29, Ln. 20 – Pg. 30, Ln. 2). Therefore, the teachings of Burgdorf in view of Fleming, render a method of inhibiting ATR kinase in a subject in need thereof; a method for treating a hyperproliferative disease in a subject in need thereof; a method for treating a tumor disease in a subject in need thereof, the method comprising administering to the subject the pharmaceutically acceptable salts OR the pharmaceutical composition according to the instant claims, prima facie obvious. 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp . Claims 1, 14, 16-19 and 22-29 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1, 8, 19-22 and 24 of co-pending Application No 17/778,632 in view of Burgdorf et al. (WO 2020/049017 A1, 12 March 2020, hereinafter Burgdorf , in the IDS). Although the claims at issue are not identical, they are not patentably distinct from each other. The instant claims are drawn to a pharmaceutically acceptable salt of a compound of formula (I), wherein the pharmaceutically acceptable salt is selected from the group consisting of hydrochloride, sulfate, hydrobromide, mesylate, p- toluenesulfonate , maleate, phosphate, formate , acetate, succinate, fumarate, citrate, malate, hippurate and oxalate. The claims of co-pending ‘632 application are drawn to a compound of formula (I) or a pharmaceutically acceptable salt thereof, with variables as defined in claim 1 of the reference application. Claims 8 and 24 of the reference ‘632 application teach a species of compound of formula (I) or a pharmaceutically acceptable salt thereof that anticipates the instantly claimed compound as in instant claim 1. Claim 19 of the reference ‘632 application anticipates a pharmaceutical composition as in instant claims 14 and 22. Claims 20-22 of the reference ‘632 application anticipates a method of inhibiting ATR kinase in a subject in need thereof; a method for treating a hyperproliferative disease in a subject in need thereof; a method for treating a tumor disease in a subject in need thereof, as in instant claims 16-18 , 23-29. The reference application do not teach the specific pharmaceutically acceptable salts as in instant claim 1 and 19. Burgdorf teaches 5-morpholin-4-yl-pyrazolo[4,3-b]pyridine derivatives as inhibitors of ATR used in the treatment of cancer (Title; Abstract; Pg. 1, Lns . 5-12). Burgdorf teaches pharmaceutically acceptable salts thereof, specifically hydrogen chloride, hydrogen bromide, sulfate, phosphate, … alkyl- and monoarylsulfonates , such as toluenesulfonate , … acetate, maleate , succinate, citrate, … malate, … methanesulfonate (i.e., mesylate) , …oxalate, etc.. (Pg. 15, Lns . 1-15). Burgdorf teaches an exemplary compound of example 25 with close structural similarity to the instant claims (Pg. 94, Lns . 12-20). Therefore, a person of ordinary skill in the art would have been motivated to make the said pharmaceutically acceptable salts, as instantly claimed, with a reasonable expectation of success. Claims 1, 8, 19-22 and 24 of co-pending application 17/778,632, renders the instant claims 1, 14, 16-19 and 22-29 prima facie obvious in view of Burgdorf . Therefore, instant claims 1, 14, 16-19 and 22-29 and claims 1, 8, 19-22 and 24 of co-pending Application No 17/778,632 are not patentably distinct. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Allowable Subject Matter The crystalline form I of the maleate salt of a compound of formula (I) , has been found to be free of prior art. Claims 7 and 12 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 and 14-29 are rejected. Claim 7 and 12 are objected to. No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT PADMAJA S RAO whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9918 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 9:00-5:30 pm EDT . 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, FILLIN "SPE Name?" \* MERGEFORMAT Kortney L Klinkel can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT (571) 270-5239 . 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. /P.S.R./ Examiner, Art Unit 1627 /SARAH PIHONAK/ Primary Examiner, Art Unit 1627
Read full office action

Prosecution Timeline

Nov 15, 2023
Application Filed
Dec 18, 2025
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
71%
Grant Probability
99%
With Interview (+40.4%)
2y 8m
Median Time to Grant
Low
PTA Risk
Based on 118 resolved cases by this examiner. Grant probability derived from career allow rate.

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