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 .
DETAILED ACTION
Claims 1 and 3-13 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of the species of Compound No. 1, claimed in instant claim 8 (also disclosed as Example 1 on page 108 of the instant specification),
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in the reply filed on December 31, 2025 was acknowledged in the previous Office Action. The requirement was deemed proper and therefore made FINAL in the previous Office Action.
Applicant’s claimed compound genus has a number of variables and their permutations and combinations result in a vast number of compounds that are generically claimed. In an initial attempt to examine a broad scope of compounds embraced by instant claim 1, over 83,200 Chemical Abstract Registry numbers were recovered in one database search alone.
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Therefore, the claimed products in the instant application have been examined according to MPEP §803.02.
The instant product claims have been examined to the extent that they are readable on the elected species of Compound No. 1. Since no prior art was found on the elected species, the examination was expanded within the compound genus until prior art was found, in which case, the examination stopped and prior art has been applied against the claims. Note, MPEP §803.02. The subject matter of the expanded search and examination thus far, inclusive of the elected species of Compound No. 1, is as follows:
a compound of instant Formula 1,
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or a tautomer, a pharmaceutically acceptable salt, a hydrate, a solvate or a stereoisomer thereof,
wherein
W1 represents C;
W2 represents C;
W3 represents C;
W4 represents C;
W5 represents N;
W6 represents N;
W7 represents N;
(W1--W7 are defined to make up a benzotriazole
ring)
Z is absent;
R5 represents -A-(R6)y;
A represents a substituted or unsubstituted
piperidine (i.e., a C5 heterocyclic group); and
all other variables are as defined in instant independent claim 1.
As a result of the current amendments to the claims per the Amendment filed May 20, 2026, the above identified expanded search and examination has not been further expanded beyond that which is stated above.
Subject matter not embraced by the above identified expanded search and examination is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on
December 31, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 20, 2026 was filed after the mailing date of the non-final Office Action on
February 20, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Claims 10 and 13 claim a pharmaceutical composition comprising a compound of instant claim 1. However, no other ingredient is recited in these composition claims. Therefore, Claims 10 and 13 have been interpreted as reading on just the compound of claim 1. Prior art will be considered and applied against these claims based on this interpretation.
Claims 11 and 12 claim an inhibitor or activator which comprise a compound of instant claim 1. Claims 11 and 12 have been considered and are deemed intended use claims. The intended use (i.e., an inhibitor or activator) is not considered a limitation and is of no significance to the construction of these claims since the body of these claims describe structurally complete inventions such that deletion of the intended use language from each of claims 11 and 12 do not affect the structure of the claimed invention. Claims 11 and 12 have been interpreted as reading on just the compound of claim 1. Therefore, prior art will be considered and applied against these claims based on this interpretation.
Rejections and objections made in the previous Office Action that do not appear below have been overcome by Applicant’s amendments to the specification and to the claims. Therefore, arguments pertaining to these rejections and objections will not be addressed.
As a result of the current amendments to the claims per the Amendment filed May 20, 2026, the following rejections apply.
Claim Rejections - 35 USC § 112
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, 3-7 and 9-13 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.
This is a new matter rejection. No support was found in the originally filed specification or the originally filed claims for the language “or a terminal atom of R6 is bonded to the same carbon of A as a first atom of R6 … containing at least one heteroatom of N, O and S,” as amended under the definition of the R6 variable in currently amended claim 1 (page 4, lines 16-23 of the page). Applicant did not state where exactly in the specification or the originally filed claims support could be found for this amendment to the definition of the R6 variable. Applicant should specifically point out the support in the original disclosure {page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I). Therefore, the claims lack written description as such.
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 1, 3-7 and 9-13 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.
In currently amended claim 1, under the definition of R6, the phrase “or a terminal atom of R6 is bonded to the same carbon of A as a first atom of R6 … containing at least one heteroatom of N, O and S,” is confusing as to its meaning (page 4, lines 16-23 of the page). Therefore, claim 1 is indefinite because the metes and bounds of the claim cannot be ascertained.
Claims dependent on claim 1 which do not resolve the problem in claim 1 are also found indefinite.
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.
Claims 1, 3-7 and 9-13 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
the compound of PubChem CID 83681378 {National Center for Biotechnology Information. "PubChem Compound Summary for CID 83681378, 5-Methoxy-1-piperidin-4-ylbenzotriazole" PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/5-Methoxy-1-piperidin-4-ylbenzotriazole. Accessed 20 January, 2026, create date October 20, 2014},
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{a compound of instant Formula 1,
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,
wherein
W1 is C;
W2 is C;
W3 is C;
W4 is C;
W5 is N;
W6 is N;
W7 is N;
R1 is hydrogen;
R2 is hydrogen;
R3 is C1 alkoxy;
R4 is hydrogen;
Z is absent;
R5 represents -A-(R6)y;
A represents a C5 heterocyclic group (i.e., unsubstituted piperidine); and
y is zero};
the compound of PubChem CID 2735464 {National Center for Biotechnology Information. "PubChem Compound Summary for CID 2735464, 1-(piperidin-4-yl)-1H-1,2,3-benzotriazole" PubChem, https://pubchem.ncbi.nlm.nih.gov/compound/1-_piperidin-4-yl_-1H-1_2_3-benzotriazole. Accessed 20 January, 2026, create date July 19, 2005},
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,
{a compound of instant Formula 1,
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,
wherein
W1 is C;
W2 is C;
W3 is C;
W4 is C;
W5 is N;
W6 is N;
W7 is N;
R1 is hydrogen;
R2 is hydrogen;
R3 is hydrogen;
R4 is hydrogen;
Z is absent;
R5 represents -A-(R6)y;
A represents a C5 heterocyclic group (i.e., unsubstituted piperidine); and
y is zero };
Bissantz et al. {US 2008/0161315} – who disclose the compound 1-(4-piperidyl)-1H-1,2,3-benzotriazole hydrochloride in paragraph [0568] on page 21 (column 2, lines 2-3),
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{a pharmaceutically acceptable salt of a compound of instant Formula 1,
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,
wherein
W1 is C;
W2 is C;
W3 is C;
W4 is C;
W5 is N;
W6 is N;
W7 is N;
R1 is hydrogen;
R2 is hydrogen;
R3 is hydrogen;
R4 is hydrogen;
Z is absent;
R5 represents -A-(R6)y;
A represents a C5 heterocyclic group (i.e., unsubstituted piperidine);
y is zero; and
the pharmaceutically acceptable salt is a hydrochloric acid salt};
and
Makings et al. {WO 2005/117883 A1} – who disclose, for example, Compound No. 9 on page 34
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{a compound of instant Formula 1,
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,
wherein
W1 is C;
W2 is C;
W3 is C;
W4 is C;
W5 is N;
W6 is N;
W7 is N;
R1 is hydrogen;
R2 is hydrogen;
R3 is hydrogen;
R4 is hydrogen;
Z is absent;
R5 represents -A-(R6)y;
A represents a C5 heterocyclic group (i.e., piperidinyl) ;
y is one; and
R6 is C8 cyclic group}.
Each of the above cited prior art disclose at least one compound that is embraced by the instant currently amended claimed invention as shown above. Further, Makings et al. disclose pharmaceutical compositions comprising his compounds together with pharmaceutically acceptable carriers or vehicles (pages 26-29). Makings et al. disclose that his compounds are modulators of muscarinic receptors and can be used in the treatment of diseases such as pain conditions (pages 30-31). Therefore, each of the above cited prior art anticipates the instant currently amended claimed invention.
Response to Arguments
Applicant's arguments filed May 20, 2026 have been fully considered. Applicant argues that the definition of the R6 variable in claim 1 has been amended such that R6 does not represent hydrogen. Applicant therefore argues that the anticipatory rejection of the instant claims over the cited prior art has been overcome.
In response, the y variable in the R5 variable moiety, -A-(R6)y, can represent zero as shown in the above rejection. Therefore, the anticipation rejection of the currently amended claims over the compound of PubChem CID 83681378, the compound of PubChem CID 2735464 and Bissantz et al. {US 2008/0161315} are all maintained.
Note to Applicant: Not every piece of prior art found in the database search or class/subclass search which would anticipate and/or render obvious the instant claimed invention under examination has been applied against the instant currently pending claims under examination. See MPEP §904.03.
Allowable Subject Matter
The elected species of Compound No. 1 is allowable over the prior art of record.
Claim 8 is allowed over the prior art of record.
Conclusion
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.
This application contains subject matter not embraced by the above identified search and examination nonelected without traverse in the reply filed on
December 31, 2025. A complete reply to the final rejection must include cancellation of nonelected claims or other appropriate action (37 CFR 1.144) See MPEP §821.01.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. 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.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
June 29, 2026
Book XXIX, page 11
Prosecution Insights