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 1-23 are pending in the instant application.
Election/Restrictions
Applicant’s election with traverse of Group I,
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and the species of (2-[(6-hexyl-4-phenylquinolin-2-yl)(methyl)amino]acetic acid, disclosed on page 174 of the instant specification,
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,
in the reply filed on June 16, 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 of elected
Group I has a number of variables and their permutations and combinations result in a vast number of compounds that are generically claimed. Therefore, the compounds of elected Group I are being examined according to MPEP §803.02.
The claims within elected Group I have been examined to the extent that they are readable on the elected species identified above. Since no prior art was found on the elected species, the examination was expanded within elected Group I 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, is as follows:
a compound of instant Formula I,
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,
wherein
R1 is aryl;
none of R2-R9 are bonded with an adjoining R group
to form a fused cycloalkyl, fused
heterocycloalkyl, fused aryl or fused
heteroaryl;
Q is a bond;
X is C or N;
“A” is an unsaturated ring depicted by
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;
Y is C;
T is C;
W is C;
Z is C; and
all other variables are as defined.
As a result of the current amendments to the claims per the Amendment filed March 6, 2026, the above identified search and examination has not been further expanded beyond that which is stated above.
The claims now embraced by the above identified expanded search and examination are claims 1, 3, 5, 6, 8-14, 20 and 21. Note that claims 18 and 19 have been amended to define variable X as representing oxygen. Independent claim 15 claims specie which are embraced by instant Formula I (such as the elected species) and claim 15 claims compounds which are not embraced by instant Formula I.
Subject matter not embraced by the above indicated search and examination and Claims 2, 4, 7, 16-19, 22 and 23 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. Applicant timely traversed the restriction (election) requirement in the reply filed on June 16, 2025.
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.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on October 17, 2025 and on November 28, 2025 were filed after the mailing date of the non-final Office Action on September 9, 2025. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
As a result of the current amendments to the specification and to the claims per the Amendment filed March 6, 2026, the following objections and rejections apply.
Specification
The disclosure is objected to because of the following informalities: there are numerous pages in the substitute specification which are not completely legible. See the chemical structure at the top of page 16 and the chemical structures on pages 143-206 of the instant specification.
Response to Arguments
Applicant’s arguments filed March 6, 2026 have been fully considered. Applicant states that the written description has been amended to reflect more legible structures.
In response, the chemical structure at the top of page 16 and the chemical structures on pages 143-206 of the substitute specification filed March 6, 2026 are not completely legible. Therefore, the objection to the specification is maintained.
Claim Objections
Claims 6 and 8 are objected to because of the following informalities:
in claim 6, an “and” should been added before
“-C(O)alkyl;” (page 5, 5th line from the bottom of the page); and
in claim 8, an “or” should been added after the definition of R7 and R8 since the language that follows is an alternative definition of variable R7 (page 7, line 16 of the page).
Response to Arguments
Applicant’s arguments filed March 6, 2026 have been fully considered. Applicant argues that amendments have been made to the claims to obviate the objections to the claims.
In response, not all of the previously indicated objections were corrected. Therefore, the objections to claims 6 and 8 are maintained.
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, 3, 5, 6, 8-14, 20 and 21 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 claim 1, under the definition of variable R1, the phrase “is either unsubstituted or substituted” is unclear as to what is unsubstituted or substituted (page 3, line 12 of the page). See claim 6 and claim 8 for same.
Claim 3 is indefinite because of the definition of variable n. In independent claim 1, variable n is defined as 0, 1, 2 or 3. However, in dependent claim 3, variable n is defined as 3-8. Therefore, claim 3 is indefinite.
In claim 8, there is a dangling valence problem when variable Z1 or variable W1 represents C but is not substituted with R1. Therefore, claim 8 is indefinite.
In claim 8, under the definitions of variables Z1 and W1, there is a valence problem when either of these variables represent oxygen or represent sulfur. In instant Formula III,
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, in claim 8, the Z1 and W1 variables are a part of a 6-membered completely aromatic ring and there is a double bond between the Z1 variable and the W1 variable in the 6-membered aromatic ring. Therefore, claim 8 is indefinite.
Claims dependent on independent claim 1, independent claim 6 or independent claim 8 which do not resolve the problems in these independent claims are also found indefinite.
Response to Arguments
Applicant’s arguments filed March 6, 2026 have been fully considered. Applicant argues that amendments have been made to the claims to obviate the rejections to the claims.
In response, not all of the previously indicated rejections were addressed by the current amendments to the claims. The rejections are deemed proper and therefore, the rejections are maintained.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claim 15 is provisionally rejected under
35 U.S.C. 101 as claiming the same invention as that of claim 15 of copending Application No. 17/566,692 (reference application), US 2023/0210837, and as that of claim 15 of copending Application No. 17/742,899 (reference application), US 2022/0313681.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Response to Arguments
Applicant’s arguments filed March 6, 2026 have been fully considered. Applicant has requested that the provisional statutory double patenting rejection be held in abeyance.
In response, it is not proper to hold a provisional statutory double patenting rejection in abeyance. Claim 15 in the instant application and/or claim 15 in each of the copending applications should have been amended or cancelled so that the same invention is not being claimed.
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, 3, 5, 6, 8-15, 20 and 21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, 6, 8-16, 19 and 21-27 of copending Application No. 17/566,692 (reference application), US 2023/0210837, and over claims 3, 4, 8-13 and 15-25 of copending Application No. 17/742,899 (reference application), US 2022/0313681. Although the claims at issue are not identical, they are not patentably distinct from each other because each of the copending applications claim compounds which anticipate the instant claimed invention. See, for instance, the first compound claimed in claim 15 of copending Application No. 17/566,692 and the first compound claimed in claim 15 of copending Application No. 17/742,899, which compound is the same compound as the first compound claimed in instant claim 15. Further, the elected species in the instant application is claimed in claim 15 of both copending applications.
The instant application shares at least one common inventor with each of the copending applications. Further, the instant application is not related to either copending application and thus, no 35 USC 121 shield exists here. See MPEP 804.01.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments filed March 6, 2026 have been fully considered. Applicant has requested that the provisional nonstatutory obviousness-type double patenting rejection be held in abeyance.
In response, if in the future any arguments are presented pertaining to the provisional nonstatutory obviousness-type double patenting rejections, said arguments will be deemed untimely.
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, 5, 6, 15, 20 and 21 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
Zhang et al. {Chemical Communications (Cambridge, United Kingdom), (2018), 54(25), pages 3114-3117} – who disclose, for instance, Compound 4k on page 3115,
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{a compound of instant Formula I,
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wherein
R1 = aryl (i.e., phenyl);
R2 = hydrogen;
R3 = C1 alkyl (i.e., methyl);
R4 = hydrogen;
R5 = hydrogen;
R6 = hydrogen;
R7 = C1 alkyl (i.e., methyl);
R8 = C1 alkyl (i.e., methyl);
R9 = hydrogen;
Q = a bond;
X = N;
“A” = an unsaturated ring depicted by
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;
Y = C;
T = C;
W = C;
Z = C; and
n = 0};
Youn et al. {Advanced Synthesis & Catalysis (2018), 360(2), pages 278-283 and Supporting Information on pages S1-S128} – who disclose, for instance, Compound (4ebb) in Table 4 on page 281 and on page S28 of the Supporting Information,
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{a compound of instant Formula I,
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wherein
R1 = aryl (i.e., phenyl) substituted with alkyl (i.e., methyl);
R2 = hydrogen;
R3 = C1 alkyl (i.e., methyl);
R4 = hydrogen;
R5 = hydrogen;
R6 = hydrogen;
R7 = hydrogen;
R8 = hydrogen;
R9 = hydrogen;
Q = a bond;
X = CH;
“A” = an unsaturated ring depicted by
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;
Y = C;
T = C;
W = C;
Z = C; and
n = 0};
Carney {US Patent 3,668,207} – who disclose the 25th compound in the table in Example 4 in column 7,
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{see the claimed compound on lines 17-18 on page 11 in
instant independent claim 15};
and
Serrano-Wu et al. {US 2018/0237394} – who disclose, for instance, Compound 9 in paragraph [0182] on page 19,
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{a compound of instant Formula I,
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wherein
R1 = aryl (i.e., phenyl) substituted with halo (i.e., chloro);
R2 = C1 alkyl (i.e., methyl);
R3 = heteroaryl (i.e., pyrid-4-yl);
R4 = C1 alkyl (i.e., methyl);
R5 = hydrogen;
R6 = hydrogen;
R7 = C1 alkyl substituted with hydroxy (i.e., hydroxymethyl);
R8 = hydrogen;
R9 = hydrogen;
Q = a bond;
X = N;
“A” = an unsaturated ring depicted by
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;
Y = C;
T = C;
W = C;
Z = C; and
n = 0}.
Each of the above cited prior art disclose at least one compound that is embraced by the instant claimed invention. Carney discloses pharmaceutical compositions comprising his compounds in conjunction or admixture with excipients, diluents and other therapeutically valuable substances (column 5, lines 4-31). Carney discloses that his compounds are useful anti-inflammatory agents and can be used in the treatment or management of arthritic or dermatopathologic conditions (column 1, lines 9-32; and column 2, lines 35-38). Serrano-Wu et al. disclose pharmaceutical compositions comprising his compounds together with pharmaceutical acceptable carriers {paragraphs [0115]-[0116] on pages 11-12} which can be administered for the treatment of bacterial infections {paragraphs [0048]-[0052] on page 7}. Therefore, each of the above cited prior art anticipates the instant claimed invention.
The elected species is not allowable. See the above statutory and nonstatutory double patenting rejections.
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.
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 claims 2, 4, 7, 16-19, 22 and 23 drawn to inventions nonelected with traverse in the reply filed on June 16, 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
April 16, 2026
Book XXVIII, page 201
Prosecution Insights