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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under
37 CFR 1.114, including the fee set forth in
37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on August 19, 2026 has been entered.
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 a previous Office Action. The requirement was deemed proper and therefore made FINAL in a 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 have been 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 August 19, 2026, the above identified search and examination has been further expanded to include compounds of instant Formula I wherein variable X also can represent S.
The claims embraced by the above identified expanded search and examination are claims 1, 3, 5, 6, 8-14, 20 and 21. Note that 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 statement (IDS) submitted on June 10, 2026 was filed after the mailing date of the final Office Action on April 21, 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.
As a result of the current amendments to the claims per the Amendment filed August 19, 2026, the following rejections apply.
Duplicate Claims, Warning
Applicant is advised that should independent
claim 1 be found allowable, independent claim 6 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP §608.01(m).
Claim Objections
Claims 1, 6 and 8 are objected to because of the following informalities:
in claim 1, an “and” should be added before
“-C(O)alkyl;” for proper Markush language format (page 3, line 5 of the page);
in claim 6, an “and” should be added before
“-C(O)alkyl;” for proper Markush language format (page 5, lines 8-9 of the page); and
in claim 8, an “and” should be added before
“-C(O)alkyl;” for proper Markush language format (page 7, line 8 of the page).
Appropriate correction is required.
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.
Claim 1 is confusing because it is not clear what variable the substituent “-(CH2)q-U-(CH3)q” is defining (see page 3, lines 5-9 of the page). See independent claim 6 for same. Therefore, claims 1 and 6 are indefinite.
In claim 1, a valence problem is raised in the substituent “-(CH2)q-U-(CH3)q” when variable q is greater than 1 (see page 3, lines 5-9 of the page). Variable q is defined as representing 0 to 10 (see page 3, line 6 of the page) but there are stipulations on the definition of variable q which depends on the definition of variable U. However, there is a valence problem with the “CH3” moiety in the substituent
“-(CH2)q-U-(CH3)q” being a repeating group. See independent claim 6 for same. Therefore, claims 1 and 6 are indefinite.
Claim 1 is confusing because there are two different definitions for the R1 variable in the claim (see page 2, lines 4-6 of the page; and page 3, lines 9-11 of the page). See claims 6 and 8 for same. Therefore, claims 1, 6 and 8 are indefinite.
In claim 8, under the definition of variables R3 and R4, a dangling valence problem is raised when variable q in the substituent “-(CH2)q-U-(CH2)q” represents 1 to 10. The claimed compounds should not have dangling valences. Claims of the “dangling valence” type in which only the portion of the structure responsible for the activity is defined in the claim are indefinite because the claims are of indeterminate in scope and generally broader than any possible supporting disclosure. Ex parte Diamond, 123 USPQ 167 (POBA 1959).
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.
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, 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 August 19, 2026 have been fully considered. Applicant has again 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, 3, 5, 6, 15, 20 and 21 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
the compound of Chemical Abstracts Registry Number 1348343-78-1 {indexed in the Registry file on STN CAS ONLINE December 4, 2011},
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{a compound of instant Formula I,
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,
wherein
R1 = aryl substituted with halo (i.e., phenyl substituted with 1 chloro) ;
R2 = hydrogen;
R3 = aryl (i.e., phenyl);
R4 = hydrogen;
R5 = hydrogen;
R6 = C4 alkyl (i.e., butyl);
R7 = hydrogen;
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 = 3};
Xu et al. {Royal Society of Chemistry Advances (2016), 6(39), 32467-32470} – who disclose Compound 3g on page 32468,
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{a compound of instant Formula I,
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,
wherein
R1 = aryl (i.e., phenyl);
R2 = hydrogen;
R3 = halo (i.e., bromo);
R4 = hydrogen;
R5 = hydrogen;
R6 = hydrogen;
R7 = C1 alkyl;
R8 = C1 alkyl;
R9 = C1 alkyl;
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};
Kinoyama et al. {US Patent 8,853,242} – who disclose compound PEx 264 (column 65, lines 5-15),
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{a compound of instant Formula I,
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,
wherein
R1 = aryl substituted with halo (i.e., phenyl substituted with 3 fluoro);
R2 = hydrogen;
R3 = COOH;
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};
Wang et al. {Tetrahedron Letters (2018), 59(50), 4426-4429} – who disclose, for instance, Compound 3k in Table 2 on page 4427,
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{a compound of instant Formula I,
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wherein
R1 = aryl substituted with alkyl (i.e., phenyl substituted with pentyl);
R2 = hydrogen;
R3 = C4 alkyl (i.e., butyl);
R4 = hydrogen;
R5 = hydrogen;
R6 = is not present;
R7 = hydrogen;
R8 = hydrogen;
R9 = hydrogen;
Q = a bond;
X = S;
“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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690
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6-chloro-4-phenyl-2-(piperidin-1-yl)quinoline
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{see the claimed compound on lines 12-13 on page 11 in
instant currently amended independent claim 15};
and
Serrano-Wu et al. {US 2018/0237394} – who disclose Compound 8 in paragraph [0180] 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 = hydrogen;0
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 currently amended 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 currently amended claimed invention.
Response to Arguments
Applicant’s arguments filed August 19, 2026 have been fully considered. Applicant argues that the compound cited in Carney does not fit within the scope of claims 1 or 6 prior to the instant amendment because R3 previously precluded that possibility of the R3 variable being a chloro substituent.
In response, the Carney reference anticipates independent claim 15 because the compound disclosed in Carney is the same as a compound being claimed in instant currently amended independent claim 15. The rejection is deemed proper and therefore, the anticipation rejection of instant currently amended independent claim 15 under 35 USC 102(a)(1) over the disclosure in Carney is maintained.
Applicant argues that none of the compounds disclosed in Serrano-Wu et al. fit within the scope of the instant claims.
In response, it is disagreed that none of the compounds disclosed in Serrano-Wu et al. fit within the scope of the instant currently amended claims. See Compound 8 on page 19 of Serrano-Wu et al. Therefore, the anticipation rejection of the instant claims under 35 USC 102(a)(1) over the disclosure in Serrano-Wu et al. is maintained.
The elected species is not allowable. See the above provisional 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.
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
August 28, 2026
Book XXVIII, page 201
Prosecution Insights