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, 5, 14, 29, 31, 32, 41, 45, 53 and 54 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I,
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and the species of Example 2-3, disclosed on page 232 of the instant specification,
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in the reply filed on March 5, 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 the full scope of compounds currently claimed, over 31,100 Chemical Abstract Registry numbers were recovered in one database search alone.
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Therefore, the product claims in the instant application have been examined according to
MPEP §803.02.
The instant claims have been examined to the extent that they are readable on the elected species of Example 2-3. Since no prior art was found on the elected species, the examination was expanded within independent claim 1 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 Example 2-3, is as follows:
a compound of instant formula (I),
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where
Z = a bond;
R4 =
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;
W1 = O; and
all other variables are as defined in
independent claim 1.
Claims embraced by the above identified expanded search and examination are claims 1, 14, 19, 28, 29, 31, 32, 41, 45, 46, 53 and 54.
As a result of the current amendments to the claims per the Amendment filed August 12, 2026, the above identified search and examination has not been further expanded beyond that which is indicated above.
Subject matter not embraced by the above identified search and examination and Claim 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 5, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on August 12, 2026 was filed after the mailing date of the non-final Office Action on
May 12, 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.
Objections and rejections made in the previous Office Action which do not appear below have been overcome by Applicant’s amendments to the specification and to the claims. Therefore, arguments pertaining to these objections and rejections will not be addressed.
As a result of the current amendments to the claims per the Amendment filed August 12, 2026, the following rejections now apply.
Claim Rejections - 35 USC § 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.
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, 14, 29, 31, 32, 41, 45, 53 and 54 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.
Claim 1 is now confusing because currently amended claim 1 has two different definitions of variable n (see page 5 and page 6). Therefore, claim 1 is indefinite.
Claims dependent on claim 1 which do not resolve the problem in claim 1 are also found indefinite.
Claim 14 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for the ring found on the last line of page 10 in claim 14 and the ring found on the first line of page 11 which are defining the R4 variable (which includes the definition of the W1 variable),
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.
See also the compound claimed on page 17, row 2, column 2, in claim 41 for same,
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. Therefore, claims 14 and 41 are indefinite.
Claim 29 now lacks antecedent basis from currently amended claim 1 because there is now no earlier recitation in claim 1 for the R1 heteroaryl ring to be substituted with an aminoC1-C3alkyl as found in claim 29. Therefore, claim 29 is indefinite.
Response to Arguments
Applicant's arguments filed August 12, 2026 have been fully considered. Applicant argues that the two rings in claim 14 identified above do have proper antecedent basis from claim 1 when variable W1 represents SO2NR15’ and NR15”C(O).
In response, the substituents which define the W1 variable are read from left to right. Therefore, one skilled in the art would expect for the sulfur in the W1 substituent SO2NR15’ to be attached to the carbon which is substituted with R10 and R10’ in the R4 substituent
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and the nitrogen in the W1 substituent SO2NR15’ to be attached to the carbon which is substituted with R13 and R13’ in the R4 substituent
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. However, just the reverse is shown in both of the problematic rings in claim 14. Therefore, Applicant’s arguments are not persuasive. The rejection is maintained.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14, 29 and 41 are rejected under
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 fails to further limit claim 1 because claim 14 is broader in scope than claim 1. There are rings on pages 10 and 11 in claim 14 that are defining the R4 variable,
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but these two rings are not found under the definition of the R4 variable in claim 1. See also the compound on page 17, row 2, column 2, in claim 41 for same,
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.
Claim 29 fails to further limit claim 1 because claim 29 is now broader in scope than currently amended claim 1. Claim 1 has been amended whereby the R1 heteroaryl ring can no longer be substituted with an aminoC1-C3alkyl as found in claim 29.
Response to Arguments
Applicant's arguments filed August 12, 2026 have been fully considered. See the Response provided above under 35 USC 112(b) in regard to the rings
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being problematic in claims 14 and 41. The rejection is maintained.
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)(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, 29, 31, 41, 45, 53 and 54 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
Chen et al. {WO 2023/159087 A1} – who disclose, for instance, Example 29 (page 85) and the compound at the top of page 116,
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{a compound of instant formula (I),
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where
Z = a bond;
R1 = aryl (i.e., naphthyl), which aryl is substituted with C2 alkyl, halo and hydroxy;
R2 = hydrogen;
R3 = halo (i.e., fluoro);
R7 = hydrogen;
R4 =
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,
where
R8 = hydrogen,
R8’ = hydrogen,
n’ =2,
Set 1 of R9 and R9’
R9 = hydrogen,
R9’ = hydrogen,
Set 2 of R9 and R9’
R9 = hydroxy,
R9’ = C1 alkyl,
R10 = hydrogen,
R10’ = hydrogen,
R13 = hydrogen,
R13’ = hydrogen, and
W1 = O;
X = O; and
R5 =
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where
n = 1; and
R20 = halo (i.e., fluoro)
-- OR –
the compound claimed in instant claim 41 on page 23, row 3, column 2},
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(page 116 of Chen et al.)
{a compound of instant formula (I),
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where
Z = a bond;
R1 = aryl (i.e., naphthyl), which aryl is substituted with hydroxy;
R2 = hydrogen;
R3 = halo (i.e., fluoro);
R7 = halo (i.e., chloro);
R4 =
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,
where
R8 = hydrogen,
R8’ = hydrogen,
n’ =2,
Set 1 of R9 and R9’
R9 = hydrogen,
R9’ = hydrogen,
Set 2 of R9 and R9’
R9 = hydrogen,
R9’ = hydrogen,
R10 = hydrogen,
R10’ = hydrogen,
R13 = hydrogen,
R13’ = hydrogen, and
W1 = O;
X = O; and
R5 =
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,
where
n = 1; and
R20 = halo (i.e., fluoro)}
and
Jones et al. {WO 2022/258974 A1} – who disclose, for instance, Example 17 (page 89) and Example 26 (page 102)
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{a compound of instant formula (I),
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where
Z = a bond;
R1 = monocyclic heteroaryl ring containing two nitrogen atoms (i.e., pyrazolyl),
which heteroaryl ring is substituted with haloC1alkyl;
R2 = hydrogen;
R3 = C1alkyl;
R7 = hydrogen;
R4 =
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,
where
R8 = hydrogen,
R8’ = hydrogen,
n’ =2,
Set 1 of R9 and R9’
R9 = hydrogen,
R9’ = hydrogen,
Set 2 of R9 and R9’
R9 = hydrogen,
R9’ = hydrogen,
R10 = hydrogen,
R10’ = hydrogen,
R13 = hydrogen,
R13’ = hydrogen, and
W1 = O;
X = O; and
R5 =
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where
n = 0),
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{a compound of instant formula (I),
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where
Z = a bond;
R1 = aryl (i.e., naphthyl), which aryl is substituted with C2 alkynyl, halo and
hydroxy;
R2 = hydrogen;
R3 = halo (i.e., fluoro);
R7 = hydrogen;
R4 =
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,
where
R8 = hydrogen,
R8’ = hydrogen,
n’ =2,
Set 1 of R9 and R9’
R9 = hydrogen,
R9’ = hydrogen,
Set 2 of R9 and R9’
R9 = hydrogen,
R9’ = hydrogen,
R10 = hydrogen,
R10’ = hydrogen,
R13 = hydrogen,
R13’ = hydrogen, and
W1 = O;
X = O; and
R5 =
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where
n = 1; and
R20 = halo (i.e., fluoro).
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, each of Chen et al. {pages 2, 27 and 28} and Jones et al. {paragraphs [00106] and [00169]-[00172] on pages 38, 52 and 53} disclose pharmaceutical compositions comprising their respective compounds together with a pharmaceutically acceptable adjuvants, diluents, carriers and/or excipients and that the pharmaceutical composition can be formulated for oral administration. Therefore, each of the above cited prior art anticipates the instant currently amended claimed invention.
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 Example 2-3, disclosed on page 232 of the instant specification, is allowable 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 and Claim 5 drawn to an invention nonelected without traverse in the reply filed on March 5, 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
October 7, 2026
Book XXIX, page 43
Prosecution Insights