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 1-16 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 55, disclosed on page 273 of the instant specification,
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in the reply filed on May 2, 2025 was acknowledged in the previous Office Action. The requirement was deemed proper and therefore made FINAL in the previous Office Action.
Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 May 2, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on October 30, 2025 was filed after the mailing date of the non-final Office Action on
July 31, 2025. 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
The instant Q0 variable in independent claim 1 represents a 5-9 membered aryl or heteroaryl. The definition of “heteroaryl” and “aromatic” is found on page 38 of the instant specification (reproduced below),
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Applicant regards the ring system,
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, as being embraced by the term “heteroaryl”. See page 2 of the Response to Restriction Requirement dated May 2, 2025 and the Interview Summary, including evidentiary support submitted by Applicant on
July 19, 2025. The ring system,
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, is found in the Q0 variable position in Formula (III), Formula (IV) and Formula (V) in dependent claims 3-5, respectively. Therefore, the ring system,
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, will be considered embraced by the term “heteroaryl” in the instant claimed invention.
Rejections and objections made in the previous Office Action that do not appear below have been overcome by Applicant’s amendments to the claims or Applicant’s persuasive arguments. Therefore, arguments pertaining to these rejections and objections will not be addressed.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
in claim 1, the phrase “two of R6 groups” should be changed to “or two R6 groups” because the subject matter which follows is an alternative definition of the R6 variable (line 8 of page 3); and
in claim 12, the phrase “two of R5 groups” should be changed to “two R5 groups” (line 3 of the claim).
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered. Applicant argues that claims 1 and 12 have been amended to be consistent with the Examiner’s suggestions. In response, not all of the previously identified claim changes are found in the current claims.
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 1-4 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11,501,284 (see especially the claimed compound in claim 7); and over claims 1-23 of U.S. Patent No. 12,086,788 (see claims 1 and 17). Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. 11,501,284 claims at least one compound that anticipates the instant claimed invention. Further, U.S. Patent No. 12,086,788 claims a method for inhibiting Bruton’s tyrosine kinase activity in a subject comprising administering a compound of Formula (I),
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, which compounds of Formula (I) render obvious the instant claimed invention. Additionally, the disclosure in U.S. Patent No. 12,086,788 (columns 5-6) disclose compounds which are embraced by its Formula (I) in claim 1 and these disclosed compounds anticipate the instant claimed compounds of Formula (I).
The indiscriminate selection of “some” among “many” is prima facie obvious, In re Lemin, 141 USPQ 814 (C.C.P.A. 1964). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity {e.g., an inhibitor of Bruton’s tyrosine kinase (BTK)}.
One skilled in the art would thus be motivated to prepare products embraced by the above cited U.S. Patents to arrive at the instant claimed products with the expectation of obtaining additional beneficial products which would be inhibitors of BTK and can be administered to a subject to treat, for instance, multiple myeloma. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
The instant application and each of the above cited U.S. Patents share a common inventor. Further, the instant application and the U.S. Patents are not related to each other and thus, no 35 USC 121 shield exists here. See MPEP 804.01. Therefore, the claims in the above cited U.S. Patents anticipate and/or render obvious the instant claimed invention.
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered. Applicant has requested that the nonstatutory obviousness-type double patenting (ODP) rejections be held in abeyance until the claims are allowable except for the ODP rejections.
In response, if in the future any arguments are presented pertaining to the nonstatutory obviousness-type double patenting rejections, said arguments will be deemed untimely.
Claims 1-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the conflicting claims of the following co-pending applications. See Table below.
Copending Application No.
{USPG PUB}
Conflicting Claims
See especially
17/431,460
(now allowed)
{US 2022/0135569}
Claims 1 and 4-6
See the last compound listed on page 5 in Claim 5
18/033,481
{US 2023/0382900}
Claims 1-8
See the species in Claim 6
18/704,243
{US 2024/0390368}
Claims 1-10
See the compound genus in claim 1
18/020,980
{US 2023/0346779}
Claims 1-17
See Claim 3 and the specie in Claim 4
18/798,308
{US 2025/0045728}
Claims 12-30
See the species in Claim 12
.
Each of the above cited copending applications claim products that anticipate and/or render obvious the instant claimed invention.
The indiscriminate selection of “some” among “many” is prima facie obvious, In re Lemin, 141 USPQ 814 (C.C.P.A. 1964). The motivation to make the claimed compounds derives from the expectation that structurally similar compounds would possess similar activity {e.g., an inhibitor of Bruton’s tyrosine kinase (BTK)}.
One skilled in the art would thus be motivated to prepare products embraced by the copending applications to arrive at the instant claimed products with the expectation of obtaining additional beneficial products which would be inhibitors of BTK. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
Each of the above cited copending applications share a common inventor with the instant application. Therefore, each of the above cited copending applications 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.
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered. Applicant has requested that the provisional nonstatutory obviousness-type double patenting (ODP) rejections be held in abeyance until the claims are allowable except for the ODP rejections.
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. Further, it is noted that Application No. 17/431,460 has now been allowed since the previous Office Action in the instant application.
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 1-4 and 15 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
the compound of Chemical Abstracts Registry Number 2374918-45-1 {indexed in the Registry file on STN CAS ONLINE September 10, 2019},
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{a compound of instant Formula (I),
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wherein
Q0 =
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, where
j = 2, one R7 = methyl and the other R7 = ORa and Ra = hydrogen;
Q1 = 6-membered aryl (i.e., phenylene) where m = zero;
Q2 = 6-membered heterocycloalkyl (i.e., piperazinyl) where i = zero;
Q3 = 5-membered heteroaryl (i.e., pyrrolyl) where
n = 2,
two R5 groups are taken together to form a cycloalkyl (i.e., a
cyclopentyl), which cycloalkyl is substituted with two Rd, and
each Rd = methyl;
Q4 = 6-membered heteroaryl (i.e., pyridyl) where
R3 = hydroxymethyl, and
R4 = hydrogen;
W = -C(O)-;
Z = NH;
Warhead =
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, where
R8 = hydrogen, and
R9 = hydrogen; and
R0 = hydrogen};
the compound of Chemical Abstracts Registry Number 2374918-39-3 {indexed in the Registry file on STN CAS ONLINE September 10, 2019},
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{a compound of instant Formula (I),
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wherein
Q0 =
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, where
j = 2, one R7 = methyl and the other R7 = ORa and Ra = hydrogen;
Q1 = 6-membered aryl (i.e., phenylene) where
m = 1,
R1 =heterocycloalkyl (i.e., piperazinyl) substituted with one Rd, and
Rd = methyl;
Q2 = 6-membered heterocycloalkyl (i.e., piperazinyl) where i = zero;
Q3 = 5-membered heteroaryl (i.e., pyrrolyl) where
n = 2,
two R5 groups are taken together to form a cycloalkyl (i.e., a
cyclopentyl), which cycloalkyl is substituted with two Rd, and
each Rd = methyl;
Q4 = 6-membered heteroaryl (i.e., pyridyl) where
R3 = hydroxymethyl, and
R4 = hydrogen;
W = -C(O)-;
Z = NH;
Warhead =
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, where
R8 = hydrogen, and
R9 = hydrogen; and
R0 = hydrogen};
and
the compound of Chemical Abstracts Registry Number 2374918-41-7 {indexed in the Registry file on STN CAS ONLINE September 10, 2019},
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{a compound of instant Formula (I),
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wherein
Q0 =
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, where
j = 2, one R7 = methyl and the other R7 = ORa and Ra = hydrogen;
Q1 = 6-membered aryl (i.e., phenylene) where
m = 1,
R1 =heterocycloalkyl (i.e., piperazinyl) substituted with two Rd,
one Rd = methyl and the other Rd = heterocycloalkyl (i.e., oxetanyl);
Q2 = 6-membered heterocycloalkyl (i.e., piperazinyl) where i = zero;
Q3 = 5-membered heteroaryl (i.e., pyrrolyl) where
n = 2,
two R5 groups are taken together to form a cycloalkyl (i.e., a
cyclopentyl), which cycloalkyl is substituted with two Rd, and
each Rd = methyl;
Q4 = 6-membered heteroaryl (i.e., pyridyl) where
R3 = hydroxymethyl, and
R4 = hydrogen;
W = -C(O)-;
Z = NH;
Warhead =
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, where
R8 = hydrogen, and
R9 = hydrogen; and
R0 = hydrogen}.
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. The Registry record for the compound of Chemical Abstracts Registry Number 2374918-41-7 provides the predicted solubility in water. Water is a well-known pharmaceutically diluent. See Table I on page 766 in Rowe, Raymond C, Paul J. Sheskey, and Marian E Quinn. {Handbook of Pharmaceutical Excipients. London: Pharmaceutical Press, 6th Edition, 2009, pages 766-770}. Therefore, each of the above cited prior art anticipate the instant claimed invention.
Response to Arguments
Applicant's arguments filed October 30, 2025 have been fully considered. Applicant argues that the compound of Chemical Abstracts Registry Number 2374918-45-1, the compound of Chemical Abstracts Registry Number 2374918-39-3 nor the compound of Chemical Abstracts Registry Number 2374918-41-7 are qualified as prior art references under 35 USC §102(b)(1)(B). Applicant argues that each of these compounds were disclosed on STN CAS ONLINE less than one year before the effective filing date of PCT/US2020/047196 (the instant 371 application). Applicant argues that the three compounds were first disclosed in PCT publication WO 2019/161152 (published August 22, 2019) and names a single inventor (Yi Chen), which is the same inventor in the instant application.
In response, Applicant did not submit an affidavit or declaration under 37 CFR 1.130(b) (an affidavit or declaration of prior public disclosure) as required to invoke an exception under AIA 35 USC 102(b)(1)(B). See both MPEP 2153.02 and MPEP 2155.02 for the proper requirements. Therefore, the rejection is maintained.
The elected species of Example 55, disclosed on page 273 of the instant specification, is not allowable. See the claims in copending Application No. 18/020,980.
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 claim 16 drawn to an invention nonelected without traverse in the reply filed on May 2, 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
January 13, 2026
Book XXVIII, page 163