DETAILED ACTION
A Restriction Requirement was mailed 4 September 2025 (“Restriction Requirement”).
Applicant’s reply to Restriction Requirement was received 3 December 2025 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 1–5, 11, 13, 17, 21, 24, 32, 34, 35, and 38–43 are pending.
Claim 1 is amended.
Claims 6–10, 12, 14–16, 18–20, 22, 23, 25–31, 33, 36, and 37 are canceled.
Priority
The instant application was filed 13 April 2023; is a national stage application of PCT/CN2021/123600, filed 13 October 2021, and claims priority to PCT/CN2020/120927, filed 14 October 2020. Acknowledgment is made of applicant’s claim for foreign priority and a copy of the priority document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 25 May 2023; 7 December 2022; 22 April 2024; and 29 August 2024 are acknowledged and have been considered.
Reply to Lack of Unity of Invention Restriction Requirement and Election of Species
Applicant’s election without traverse of Group I (claims 1–5, 11, 13, 17, 21, 24, 32, 34, 35, and 38–42) is acknowledged. Group II (claim 43) is withdrawn until eligible for rejoinder.
Applicant’s election of species without traverse of compound 148 is acknowledged. Applicant asserts claims 1–5, 11, 13, 17, 21, 24, 32, 35, 38, 40, and 42 read on compound 148.
Scope of Search and Examination
A prior art search and examination will begin with the elected species. (MPEP § 803.02). If no prior art is found that would anticipate or render obvious the elected species, then the search will be extended to other species of the elected group. If no prior art is found that would anticipate or render obvious the elected group, then the search will be extended to non-elected species in non-elected groups. If prior art is found that anticipates or renders obvious a non-elected species or group, then the search will stop and the Markush-type claim will be rejected. The prior art search will not be extended unnecessarily to cover all non-elected species.
Should Applicant overcome the rejection by amending the Markush-type claim, then the claim will be reexamined. The prior art search will be extended to the extent necessary to determine the patentability of the Markush-type claim. If prior art is found during reexamination that anticipates or renders obvious the amended Markush-type claim, then the claim will be rejected, any claims to the nonelected species will be held withdrawn from further consideration, and the Office action will be final.
In this case, Applicant’s elected species has been searched and is free of the prior art.
The search was extended to non-elected species: compounds of Formula I in which Q1 = piperazinyl and A =
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; and those compounds are free of the prior art.
The search was extended to non-elected species: compounds of Formula I in which Q1 = piperazinyl and A = any chemical moiety [see claim interpretation below]. Prior art was found that anticipates or renders obvious instant Formula I, so the search was stopped and not unnecessarily extended.
The Markush-type claim 1 is rejected herein along with other relevant claims, and the non-rejected claims are withdrawn per the procedure outlined above until the Markush-type claim has been amended to overcome the prior art rejection.
Claim Rejections - 35 U.S.C. § 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.
(i) Claim 41 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The written description and the claims are separate statutory requirements. Under modern claim practice, claims must stand alone to define an invention. Ex parte Fressola, 27 USPQ2d 1608 (BPAI 1993).
Claim 41 includes a list of compound reference numbers without providing a chemical structure for each compound. As a result, one of ordinary skill in the art must refer back to the specification to understand what the claimed invention is. MPEP 2173.05(s) states that incorporation by reference to figures or tables is permitted only in exceptional circumstances and the current prosecution record does not evidence exceptional circumstances.
Examiner recommends inserting the chemical structures for the compounds in the claim.
Appropriate correction is required.
(ii) Claims 1, 32, 34, 35, 38, 41, and 42 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites, “A is a chemical moiety that binds HSP90 protein.”
The phrase is not defined in the specification. The term “chemical moiety” is so vague that it could mean any number of things, including an atom, a functional group, or a compound. The term “binds” is also vague and could mean several things, including a covalent bond, ionic bond, or another type of binding interaction between the entities (e.g., molecular cage). Moreover, the term “that binds HSP90 protein” is an inherent property of the “chemical moiety.” The scope of compounds possessing that property is unknown and cannot be determined because it would require assaying every existing compound to determine whether it possesses the property. In other words, the scope of the claim term is indefinite.
Claims 32, 34, 35, 38, 41, and 42 are rejected because the incorporate by reference all the limitations of claim 1 without curing the issue.
Appropriate correction is required.
Examiner recommends replacing the phrase with specific chemical structures, such as those depicted in claim 2.
Claim Interpretation
Consistent with the goals of compact prosecution and the indefiniteness rejection above, and for the purpose of executing a prior art search, indefinite variable A has not been limited to a particular structure. For the prior art search, variable A could be any chemical moiety.
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)(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, 3–5, 11, 13, 32, and 42 are rejected under 35 U.S.C. § 102(a)(2) as being anticipated by WO2021/051034 (“Chan”) [IDS].
Chan discloses compound 47,
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, which anticipates Formula I as follows:
L =
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or
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;
A =
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or
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;
Q1 = nitrogen containing heterocycle; R5 = C(O)Y; Y = alkenyl;
j = 0 (R7 is absent);
Q2 = bond; and R8 = aryl. (Chan, ¶245).
Chan discloses pharmaceutical compositions. (Id., ¶¶184–192).
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 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046 (Fed. Cir. 1993); In re Longi, 759 F.2d 887 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937 (CCPA 1982); In re Vogel, 422 F.2d 438 (CCPA 1970); In re Thorington, 418 F.2d 528 (CCPA 1969).
Please note the following information regarding terminal disclaimers:
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(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.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending App. No. 18/031,701 (reference claims).
18/031,679
18/031,701
Claim 1: Formula I:
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L = linker [no structural requirement]
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Claim 1: Formula: H-L-T
T = target protein binder [no structural requirement]
L =linker [no structural requirement]
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Although the claims at issue are not identical, they are not patentably distinct from each other because they cover the same compounds. Comparing instant formula (I) to the formula in the reference claim, instant variable A is identical to variable H because there are overlapping definitions for variables V, W, and R1; the linkers L can be identical; and the instant bicyclic heterocyclic core corresponds to variable T, which has no structural requirements. As such, an infringer of a patent granted based on the claim of the instant application or reference application would also be an infringer of the other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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/JASON M. NOLAN/Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623