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 the Application
Claims 1, 7, 12, 14-29 are pending as of the response filed 03/20/2026. Claims 1, 7, 12, 14-29 are examined herein.
Applicant’s submission of an English translation of the foreign priority application, CHINA 202110558670.5 filed 05/21/2021 is acknowledged. In consideration of the English translation, the effective filing date of instant claims 1, 7, 12, 14-29 is 05/21/2021.
The 35 U.S.C. § 112(b) rejection of previous record is withdrawn in consideration of the claim amendments. and
The 35 U.S.C. § 112(d) rejection of previous record is withdrawn in consideration of the claim amendments.
The claim amendments do not overcome the 35 U.S.C. § 102 rejection of previous record since contrary to Applicants remarks, Li teaches a mesylate salt of compound of instant formula (I). Thus, the 35 U.S.C. § 102 rejection of record is maintained and updated to reflect the claim amendments (Li is now prior art under 35 U.S.C. 102(a)(2) only, since the priority claim has been perfected with the English translation).
Applicant’s discussion of unexpected results for the compound of instant formula (I) in comparison to the compound of example 25 of Burgdorf with respect to ATR enzyme inhibitory activity (3 nM vs 73 nM for example 25 of Burgdorf) and inhibitory activity against LoVo cell proliferation (43 nM vs 316 nM for example 25 of Burgdorf) in pages 8-9 of the remarks dated 03/20/2026 was found to be persuasive. The 35 U.S.C. § 103 rejection of record over Burgdorf in view of Fleming is hereby withdrawn.
The nonstatutory double patenting rejection of previous record is maintained and updated to reflect the claim amendments. Applicants’ arguments have been fully considered and is addressed below.
Information Disclosure Statement
The information disclosure statement submitted on 03/20/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102 – Maintained and updated
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)(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)(2) as being anticipated by Li et al. (AU 2020386587 A1, publication date 27 May 2021, international filing date 20 November 2020, hereinafter Li, of previous record).
The Li et al. reference is an equivalent of WO 2021/098811 A1, in the IDS. The current 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).
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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.
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Li teaches reagents that provide acidic conditions in the synthesis schemes to include methanesulfonic acid (Pg. 33, third full paragraph). This would lead to the formation of the mesylate salt.
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.
Double Patenting – Maintained and updated
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 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-11 and 13 of U.S. Patent No. 12,559,488 B2 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 mesylate, maleate, succinate, fumarate, citrate, malate, hippurate and oxalate.
The claims of the reference ‘488 patent are drawn to a compound of formula (I) or a pharmaceutically acceptable salt or tautomer thereof, with variables as defined in claim 1 of the reference patent. Claim 8 of the reference ‘488 patent teaches 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 9 of the reference ‘488 patent anticipates a pharmaceutical composition as in instant claim 14. Claims 10-11 and 13 of the reference ‘488 patent 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 and 24.
The reference patent does not teach the specific pharmaceutically acceptable salts as in instant claims 1, 19, 22-23 and 25-29.
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 bromide, … 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).
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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, 8-11 and 13 of the ‘488 patent, 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, 8-11 and 13 of the ‘488 patent are not patentably distinct.
This is a nonstatutory double patenting rejection.
Response to Arguments
Applicants argue on pages 9-10 of the remarks dated 03/20/2026 that “Of note, the '632 application has been granted into a patent (US12559488). Compared to the pending claims of the present application, the closest claim is claim 7 which recites the same compound of formula (I) or a pharmaceutically acceptable salt or tautomer thereof. However, none of the granted claims discloses a specific salt form”. Applicants argue “As discussed above associated with the obviousness rejection, in view of the unexpected superior properties possessed by the compound of formula (I), Applicants respectfully submit that a person of ordinary skill in the art would not have a reasonable expectation of success by relying on the teaching of Burgdorf to arrive at the present claims as asserted by the Examiner”.
Applicant's arguments have been fully considered but they are not persuasive.
The nonstatutory double patenting rejection has been redrafted against the issued patent, US12559488. Applicants acknowledge in the remarks that the claims of the issued patent anticipates the compound of formula (I) or a pharmaceutically acceptable salt thereof (claim 8). Burgdorf has been cited to render the instant claims prima facie obvious. The unexpected results discussed by Applicants is not applicable in the instant situation, since the results are for the free base and not for specific salt forms thereof.
As such, claim 8 of the ‘488 patent anticipates the instant compound of formula (I) or a salt thereof. Burgdorf teaches compounds having the same activity as the instant compounds, ATR kinase inhibitory activity, with close structural similarity to the instant compounds.
According to MPEP § 2144.08 (II)(A)(4)(d), “Consider the properties and utilities of the structurally similar prior art species or subgenus. It is the properties and utilities that provide real world motivation for a person of ordinary skill to make species structurally similar to those in the prior art. Dillon, 919 F.2d at 697, 16 USPQ2d at 1905; In re Stemniski, 444 F.2d 581, 586, 170 USPQ 343, 348 (CCPA 1971).”
Therefore, the claims of the ‘488 patent in view of Burgdorf render the instant pharmaceutically acceptable salts prima facie obvious. Thus, the nonstatutory double patenting rejection is maintained.
Allowable Subject Matter
As previously stated, the crystalline form of the maleate salt of a compound of formula (I), has been found to be free of prior art.
Claims 7, 12 and 20-21 are allowed.
Conclusion
Claims 1, 14-19 and 22-29 are rejected.
Claims 7, 12 and 20-21 are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30 pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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