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
This Application is a 371 of PCT/CN2021/091073, filed April 29, 2021, and claims foreign priority to CN202010361013.7 and CN202110390228.6, filed April 30, 2020 and April 12, 2021, respectively, in the People’s Republic of China.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 9, 2025; June 5, 2024; and December 6, 2022 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Formal Matters – Response to Restriction/ Election – Claim Status
Applicant's election with traverse of Group I (claims 1-17) and
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in the reply filed on October 15, 2025 is acknowledged. The traversal is on the ground(s) that there is unity of invention because the cited art (WO2023061432A1) has later filing date than the present application (Remarks, p. . These arguments were fully considered and found persuasive. The Restriction/ Election requirement is therefore withdrawn.
Claims 1-19 are currently pending and subject to examination.
Claim Rejections - 35 USC § 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 5, 7, 13 and 18-19 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 5, 7, and 13, the phrase "optionally" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention.
Claim 5 recites:
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Claims 7 and 13 use similar Markush groupings to claim 5 and have a broader Markush group followed by a narrower “optional” Markush group.
One of ordinary skill in the art cannot determine the metes and bounds of the claim because the list of potential alternatives can vary and ambiguity arises as to exactly which alternatives are covered by the claim (MPEP § 2173.05(h).II). As stated in MPEP § 2173.05(c), “Description of examples and preferences is properly set forth in the specification rather than in a single claim. A narrower range or preferred embodiment may also be set forth in another independent claim or in a dependent claim. If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim.” (MPEP § 2173.05(c)). As stated in MPEP § 2173.05(d): “Description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. In those instances where it is not clear whether the claimed narrower range is a limitation, a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph should be made.” (MPEP § 2173.05(d)), While claims 5, 7 and 13 use the term “optionally” instead of “for example” or “preferably”, the groups following the term “optionally” are clearly examples falling within the broader group previously described and it is unclear if the examples are a limitation. As such, one of ordinary skill in the art cannot determine the metes and bounds of the claim.
Appropriate correction is required.
Claim 18 recites the limitation "the administration" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 18 recites: “A method for treating an sGC agonist-associated disease comprising the administration of the compound, the stereoisomer thereof or the pharmaceutically acceptable salt thereof according to claim 1.” The claim language “comprising the administration of the compound” is indefinite because:
Missing antecedent basis: An administration has not been previously established in claim 1 or earlier in the claim.
Missing recipient or subject: The claim does not specify to whom or what the compound is being administered. “The administration” is an incomplete concept without an object receiving that administration.
One of ordinary skill in the art cannot determine with reasonable certainty what are the metes and bounds of the claim because does merely preparing an administration qualify? Does it require actual delivery to a patient?
Claim 19 depends from claim 18 and does not resolve these ambiguities and is therefore also indefinite. It is furthermore unclear how claim 19 is further limiting to claim 18 because the “sGC agonist-associated disease” is in the preamble of the claim and the body of the claim does not require administering the compound to a subject in need thereof. The preamble is not further limiting to the body of a claim where it merely recites an intended use which is merely a statement of effect that may or may not be desired or appreciated (MPEP § 2111.02). If the preamble is not further limiting, then it is unclear how a limitation to the preamble could be further limiting.
Appropriate correction is required.
Nonstatutory 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 1-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/699,531 (reference application) (herein “the ‘531 Application). Although the claims at issue are not identical, they are not patentably distinct from each other because the genera of both Applications are overlapping in scope and the compounds claimed in the ‘531 Application fall within the genus of the present application.
Claim 1 is directed towards a compound of formula (II):
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. For example,
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and
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(claim 15). The ‘531 Application is directed towards a compound of formula (I):
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, which is a subgenus of instant formula (II). The ‘531 Application claims compounds which fall within the instantly claimed genus, for example,
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(the ‘531 Application, claim 7). As this compound falls within the genus of instantly claimed formula (II), claim 1 is provisionally rejected on the ground of nonstatutory double patenting.
Claims 2-14 also read on the compounds claimed in the ‘531 application and are provisionally rejected on the ground of nonstatutory double patenting.
Claims 15-16 are directed towards compounds which are so similar to the compounds of the ‘531 application that an ordinary artisan would expect them to have similar properties. For example, see the compounds cited in the rejection of claim 1 above. Therefore, claims 15-16 are provisionally rejected on the ground of nonstatutory double patenting.
Claims 17-19 are directed towards pharmaceutical compositions comprising the instantly claimed compound and methods of treating a disease comprising administering the claimed compound, as are claims 8 and 9 of the ‘531 application. Therefore, claims 17-19 are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Related Art
Claim 1 is directed towards a compound of formula (II):
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. For example,
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and
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(claim 15).
The closest prior art is Follman (US 8859569 B2). Follman teaches sGC agonists of formula (I):
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(Follman, Specification, col. 2). For example,
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(id., col. 146) and
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(id., col. 121). These compounds have the same activity and similar pyrazolo[3,4-b]pyridin-3-yl core structure. Follman, however, does not teach or suggest the peri-condensed tricyclic moiety as in the instant invention, and only teaches a bicyclic moiety or a spiro-tricyclic which is not the peri-condensed tricyclic system of the instant invention.
Conclusion
No claim is found to be allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629