Detailed Action
The present office action is in response to the amendments filed on 14 Jan 2026.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status
Claims 1-5, 13-14, 17, 21, 26, and 30-36 of the pending application have been examined on the merits. Claims 10-12, 16, 18, 22-25, and 27-28 remain withdrawn and claim 37 is newly withdrawn (see “Response to Applicant Remarks” below). Acknowledgement is made of newly added claims 30-37. Acknowledgment is made of the cancellation of claims 6-9, 15, 19-20, and 29.
Priority
The instant App. No. 17/791,283, filed 07 Jul 2022, is a National Stage Entry of International App. No. PCT/CN2021/071297, filed 12 Jan 2021, which claims foreign priority of Foreign App. No. CN202010660519.8, filed 10 Jul 2020, and CN202010046221.8, filed 16 Jan 2020.
Response to Applicant Remarks
Acknowledgement is made of the amendments filed 14 Jan 2026.
Newly submitted claim 37 is directed to an invention that lacks unity with the invention originally claimed for the following reasons: claim 37 is directed to a non-elected group.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 37 is withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
The objections to claim 1 have been rendered moot by applicant amendments.
The rejection of claim 1 under 35 U.S.C. § 112(a) is rendered moot following applicant amendments. However, the amendments introduced the issue of new matter and a new rejection under 35 U.S.C. § 112(a) has been made (see below). This rejection is necessitated by applicant amendments.
The rejections of claims 1, 5, and 13 under 35 U.S.C. § 112(b) are rendered moot following applicant amendments.
Regarding the rejection of claims 1-5, 14, 17, 21, and 26 under 35 U.S.C. § 103 over CN 111484491 (provided in the office action mailed 20 Oct 2025), hereinafter ‘491, Patani et al. (Chem Rev, 1996, 96:3147-3176; provided in the office action mailed 20 Oct 2025), hereinafter Patani, WO 2019/182960 (provided in IDS 07/07/22), hereinafter ‘960, and Bagdanoff et al. (J Med Chem, 2019, 62:1781-1792; provided in the office action mailed 20 Oct 2025), hereinafter Bagdanoff, acknowledgement is made of the English language translation of the certified copy of the foreign priority applications along with a statement that the translation of the certified copy is accurate. However, there is no indication that the nonprovisional application and the certified copy of the foreign application name the same inventors. MPEP § 216 states that if “the nonprovisional application and the certified copy of the foreign application do not name the same inventor or do not have at least one joint inventor in common, the priority date should be refused until the inconsistency is resolved.” Therefore, the priority date has not been perfected rejection is maintained. The rejection has been amended to recite the newly added claims 30-36. This rejection is necessitated by applicant amendment.
Regarding the rejection of claims 1, 5, 14, 17, and 26 under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/178316 (provided in the office action mailed 20 Oct 2025), hereinafter ‘316, applicant argues on pg. 27 of the remarks that claim 1 as amended excludes -SO2NR6R7 from the Markush group for the substitution of the heterocyclyl formed from R3 and R4 together with the N atom bound therewith and therefore ‘316 no longer anticipates the rejected claims.
Applicant arguments have been fully considered but are not persuasive because the compounds taught by ‘316 (see the restated rejection below) still read on the claims when the heterocyclyl formed by R3 and R4 is substituted by -SO2R5; where R5 is -NR9R10; R9 is H; and R10 is optionally substituted heteroaryl. Therefore, the rejection is maintained and restated below. The rejection has been amended to include newly added claim 30. This is necessitated by applicant amendment.
Claim Objections
Claim 35 is objected to because of the following informalities: There is no space between “wherein” and “R2”.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 5, 13, 14, 17, 26, and 30-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 includes the following limitation for the variable Z, “Z is -NH- or -O-…“ However, this limitation is not found in the original claims or in the specification and applicant has not pointed to where the limitation that Z is -NH- or -O- may be found in the original disclosure. Claims 2, 5, 13-14, 17, 26, and 30-36 are rejected for failing to remedy the deficiencies of the independent claim 1. Applicant may overcome this rejection by removing the new matter in claim 1.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5, 14, 17, 21, 26, and 30-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over ‘491, further in view of Patani, ‘960, and Bagdanoff.
The instant claims are directed to the following generic Formula (I):
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Examiner expanded the scope of search to include the following species of Formula (I):
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‘491 teaches compounds of reference Formula (I) (pg. 15):
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544
739
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‘491 teaches that the compound TM80 (below), also Example 18, is useful for inhibiting SHP2 with an IC50 of 98.65±15.45 nM (pg. 31; pg. 48; pg. 51-52, Table 1):
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‘491 also teaches pharmaceutical compositions comprising the reference compounds and one or more pharmaceutically acceptable carriers (pg. 34). However, ‘491 does not directly teach the species in the scope of the instant search. TM80 differs from the instant species in one way; the instant species has a =N- where TM80 has a =CH- on the core structure.
Patani teaches that bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents and the concept of bioisosterism is often considered to be qualitative and intuitive (pg. 3147, columns 1-2). Patani also teaches that there are opportunities to employ bioisosteres to gain specific insight into the quantitative structure-activity relationships associated with a specific class of drugs (pg. 3148, column 1). Patani teaches that trivalent ring equivalent of -CH= with -N= is commonly used in modern drug design (pg. 3159, column 2).
‘960 teaches Compound 110 which ‘960 teaches is useful as a SHP2 inhibitor (Abstract; pg. 38):
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Reference Compound 110 contains the same core structure as the instant compounds with different substituents.
Bagdanoff teaches the evaluation and structure-based scaffold morphing of allosteric inhibitors of SHP2 (Abstract). Bagdanoff teaches Compounds 2-5 (pg. 1782, Fig. 1; and pg. 1783, Fig. 2):
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Bagdanoff teaches creating a hit structure by identifying core components of compounds 2-4 to create compound 5 (pg. 1782, column 2 to 1784, column 1). Bagdanoff identifies the bicyclic core as being important along with the positions of the nitrogen groups.
Based on the teachings of ‘491, Patani, ‘960, and Bagdanoff, a person having ordinary skill in the art would modify the core structure of TM80, as taught in ‘491, by changing the -CH= to an -N=, as taught in Patani, to get the same core structure taught by ‘960 and arrive at the instantly claimed structure. The artisan would be motivated to make this change to gain specific insight into the quantitative structure-activity relationship associated with the specific class of SHP2 inhibiting drugs and that making this change to the core molecule has resulted in new SHP2 inhibitors, as taught by Bagdanoff. The artisan would have a reasonable expectation of success based on the teachings of ‘960, which shows the same core structure as in the instant claims is useful for inhibiting SHP2.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1, 5, 14, 17, 26, and 30 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ‘316.
The instant claims are directed to the following generic Formula (I):
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‘316 teaches compounds I(XIX)a and I(XIX)b on pg. 40, Table B:
Compound
Name
Structure
I(XIX)a
Ethyl-3-(4-ethylphenyl)-6-(4-(N-(pyridin-3-yl)sulfamoyl)piperazin-1-yl)-1H-pyrazolo[3,4-b]pyridine-4-carboxylate
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I(XIX)b
Ethyl-6-(4-(N-(4-carbamoyl-2-fluorophenyl)sulfamoyl)piperazin-1-yl)-3-(4-ethylphenyl)-1Hpyrazolo[3,4-b]pyridine-4-carboxylate
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Compound I(XIX)a reads on the instant claims when instant variables V and T are N; Z is NH; Q is CH; R2 is C(O)OR5; Y is a bond; Ring A is phenyl; R1 is alkyl; m is 1; R3 and R4 together with the N atom form a 4-11 membered heterocyclyl further substituted with SO2R5; R5 is -NR9R10; R9 is H; and R10 is heteroaryl. Compound I(XIX)b reads on the instant claims when instant variables V and T are N; Z is NH; Q is CH; R2 is C(O)OR5; Y is a bond; Ring A is phenyl; R1 is alkyl; m is 1; R3 and R4 together with the N atom form a 4-11 membered heterocyclyl further substituted with SO2R5; R5 is -NR9R10; R9 is H; and R10 is substituted heteroaryl. ‘316 also teaches a pharmaceutical composition comprising the compounds of the reference document and at least one inert pharmaceutically acceptable excipient. Therefore, ‘316 anticipates the instant generic Formula (I) and pharmaceutical compositions which include compounds of the instant generic Formula (I).
Conclusion
No claims are allowed. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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