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 1-3, 5, 6, 9, 12, 13, 16, 17, 19, 21, 24-26, 28, 29, 31, 32, 34, 36, 39-41, 45, 49, 53, 56, 57, 62, 65, 68-70, 73, 75, 77 and 79-81 are pending in the instant application.
Election/Restrictions
Applicant’s election with traverse of Group I,
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and the species of Compound A-62, disclosed on page 159 of the instant specification (reproduced below),
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in the reply filed on November 21, 2025 is acknowledged. The traversal is on the ground(s) that there is no undue burden to search and examine the inventions of Groups I and II together since Group I relates to the products of formula (I) and Group II is related to a method of use of the compound of formula (I).
Applicant’s arguments have been considered but have not been found persuasive. A search burden requisite is not the standard for a lack of unity of invention under 37 CFR 1.475. Unity of invention exists when there is a technical relationship among the claimed inventions involving a special technical feature. The expression “special technical feature” means those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. In the lack of unity requirement of October 2, 2025, it was stated that a substituted 6-membered ring-carbonyl-amino-sulfonyl moiety, was considered the technical feature and such technical feature is known in view of a compound disclosed in U.S. Patent 11,420,968. As a result, a substituted 6-membered ring-carbonyl-amino-sulfonyl moiety is not a “special technical feature” since it has been shown that a substituted 6-membered ring-carbonyl-amino-sulfonyl moiety is known. Also see the prior art rejections below. Therefore, Applicant’s arguments are not found persuasive.
The requirement is still deemed proper and is therefore made FINAL.
Claims 79-81 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 21, 2025.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement filed on November 8, 2022. The submission is in compliance with the provisions of
37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
Since the instant application claims the benefit under 35 USC § 119(e) of Provisional application 63/021,816 filed May 8, 2020, the disclosure in the provisional application was reviewed because of the possibility of intervening art. It was found that Provisional application 63/021,816 fails to provide adequate support for the entire scope of the instant claimed invention. The disclosure of the prior-filed application, Application No. 63/021,816, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. See specifically the lack of variables X3, Z and A in the provisional application as well as other more limiting variable definitions in the provisional application. Therefore, the instant claimed invention cannot rely on the filing date of Provisional application 63/021,816.
Claim Objections
Claims 1, 12 and 75 are objected to because of the following informalities:
in claim 1, an “and” should be added after the definition of variable t (see the next to the last line of the claim);
in claim 12, “the compound of” should be changed to “The compound of” (see the beginning of line 1 of the claim); and
in claim 75, an “and” should be added before the last compound claimed for proper Markush language format.
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, 9, 12, 13, 16, 17, 19, 21, 24-26, 28, 29, 31, 32, 34, 36, 39-41, 45, 49, 53, 56, 57, 62, 65, 68-70, 73, 75 and 77 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 there is a valence problem in instant formula (I),
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, due to the definitions of variables Y1, Y2, Y3, q and R7 in claim 1. Variables Y1, Y2 and Y3 represent, independently, N or CH. The 6-membered ring in which the Y1, Y2 and Y3 variables are members of is an aromatic ring. There is no availability on this 6-membered aromatic ring for a R7 substituent when variable q represents 1, 2 or 3. See claims 3 and 34 for same. Therefore, claims 1, 3 and 34 are indefinite. Correction is required.
Claims dependent on independent claim 1 which do not resolve the problems in claim 1 are also found indefinite.
Claim 17 is confusing because claim 17 refers to a Formula (II) but Formula (II) is not defined in claim 17 or in any of the claims that claim 17 depends. Therefore, claim 17 is indefinite.
Claim 29 lacks antecedent basis from the claims from which it depends because there is no earlier recitation in claim 26 for any one of the X1, X2 or X3 variables representing nitrogen as found in some of the moieties listed in claim 29 (such as the 1st moiety listed). Therefore, claim 29 is indefinite.
Claim 69 is confusing because claim 69 refers to a Formula (III) but Formula (III) is not defined in claim 69 or in claim 1. Therefore, claim 69 is indefinite.
Claim 69 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for the moiety,
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, to represent “
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” as found in claim 69 (note: the R4 variable does not represent an oxo in claim 1). Therefore, claim 69 is indefinite.
Claim 73 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for the moiety,
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, to represent “
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” as found in claim 73 (note: the R5 variable does not represent an oxo in claim 1). Therefore, claim 73 is indefinite.
Claim 75 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for the compound,
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, as found in claim 75 (page 62, column 3, row 4). Note: the R4 variable does not represent an oxo in claim 1. Therefore, claim 75 is indefinite.
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 29, 69, 73 and 75 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 29 fails to further limit the claims from which it depends because claim 29 is broader in scope than the claims from which it depends. Claim 26 does not state that any one of the X1, X2 or X3 variables can represent a nitrogen as found in some of the moieties listed in claim 29 (such as the 1st moiety listed).
Claim 69 fails to further limit claim 1 because claim 69 is broader in scope than claim 1 due to the moiety,
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, representing “
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” as found in claim 69. Claim 1 does not state that the R4 variable can represent an oxo.
Claim 73 fails to further limit claim 1 because claim 73 is broader in scope than claim 1 due to the moiety,
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, representing “
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” as found in claim 73. Claim 1 does not state that the R5 variable can represent an oxo.
Claim 75 fails to further limit claim 1 because claim 75 is broader in scope than claim 1 due to the compound,
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, as found in claim 75 (page 62, column 3, row 4). Claim 1 does not state that the R4 variable can represent an oxo.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 9, 12, 13, 21, 24, 25, 53, 56, 57, 62, 65, 68-70, 73, 75 and 77 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, 9, 12, 16-20, 22, 24, 25, 27-30, 32, 34, 36-38 and 40-42 of copending Application No. 18/711,807 (reference application), US 2025/0122191. Although the claims at issue are not identical, they are not patentably distinct from each other because the copending application claims compounds which anticipate the instant claimed invention. See the chemical structure of the elected species in the instant application in comparison with, for example, the compound claimed in column 1, row 4, on page 29 (claim 37) in copending Application No. 18/711,807,
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and claims 16 and 29 in copending Application No. 18/711,807.
The instant application and copending Application No. 18/711,807 share at least one common inventor (i.e., Hongbin Liu). The instant application and copending Application No. 18/711,807 are not related to each other and thus, no 35 USC 121 shield exists here. See MPEP §804.01. Therefore, the claims in copending Application No. 18/711,807 anticipate and/or render obvious the instant claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-3, 5, 6, 16, 17, 19, 21, 24-26, 28, 29, 31, 32, 34, 36, 39, 53, 56, 57, 62, 65, 68, 69, 73 and 77 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by:
Chen et al. {WO 2021/133817 A1} - who disclose, for instance, the compound on page 107, lines 2-4,
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{a compound of instant formula (I),
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wherein
X1 = CR8;
X2 = CR9 and R9 = hydrogen;
X3 = CR10 and R10 = hydrogen;
Y1 = CH;
Y2 = CH;
Y3 = CH;
A = N;
B = CH;
W = -CR11- and R11 = hydrogen;
Z = N;
L1 = -(CRC0RD0)uNRA0(CRC0RD0)t-
where
u = zero,
t = zero, and
RA0 = hydrogen;
L2 = -(CRC0RD0)uO(CRC0RD0)t-
where
u = zero, and
t = zero;
R1 and R8 together with the atoms to which they are
attached form a heterocyclic ring substituted with one RX group,
where RX = heterocyclyl (i.e., 1,4-dioxanyl);
R2 = heteroaryl (i.e.,
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);
R3 = aryl (i.e., phenyl) substituted with RX,
where RX = C3 cycloalkyl (i.e., cyclopropyl);
m = zero (i.e., no R4 substituent);
m1 = one;
m2 = zero;
n = zero (i.e., no R5 substituent);
n1 = zero;
n2 = zero;
p = zero (i.e., no R6 substituent);
p1 = one;
p2 = one; and
q = zero (i.e., no R7 substituent)};
and
Xue et al. {WO 2021/083135 A1} – who disclose, for instance, the compound of Example B9 on page 50,
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{a compound of instant formula (I),
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wherein
X1 = CR8;
X2 = CR9 and R9 = hydrogen;
X3 = CR10 and R10 = hydrogen;
Y1 = CH;
Y2 = CH;
Y3 = CH;
A = N;
B = CH;
W = -CR11- and R11 = hydrogen;
Z = N;
L1 = -(CRC0RD0)uNRA0(CRC0RD0)t-
where
u = zero,
t = zero, and
RA0 = hydrogen;
L2 = a bond;
R1 and R8 together with the atoms to which they are
attached form a heterocyclic ring substituted with one RX group,
where RX = C1 alkyl substituted with one RY,
and RY = C6 cycloalkyl (i.e., cyclohexyl) substituted with OH;
R2 = heterocyclyl (i.e.,
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) – see definition of “heterocyclyl” in
paragraph [50] on page 13 of the instant specification;
R3 = aryl (i.e., phenyl) substituted with RX,
where RX = C3 alkyl (i.e., isopropyl);
m = zero (i.e., no R4 substituent);
m1 = one;
m2 = zero;
n = zero (i.e., no R5 substituent);
n1 = zero;
n2 = zero;
p = zero (i.e., no R6 substituent);
p1 = one;
p2 = one; and
q = zero (i.e., no R7 substituent)}.
Each of the above cited prior art disclose at least one compound that is embraced by the instant claimed invention as shown above. The priority documents for each of the above cited prior art disclose the above identified compounds. Chen et al. {page 122, 2nd full paragraph} and Xue et al. {paragraphs [0081]-[0082] on pages 20-21} disclose pharmaceutical compositions comprising their respective compounds together with pharmaceutically acceptable carriers. Therefore, each of Chen et al. and Xue et al. anticipate the instant 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.
The elected species of Compound A-62, disclosed on page 159 of the instant specification, is not allowable. See the claims in copending Application No. 18/711,807 and especially the compound claimed in column 1, row 4, on page 29 (claim 37) in copending Application No. 18/711,807 as well as claims 16 and 29 in copending Application No. 18/711,807.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., 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 originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
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
March 16, 2026
Book XXVIII, page 283