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, 65, 79, 83, 84, 86, 87, 98 and 117-150 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 27, 2026 has been entered.
Election/Restrictions
Applicant’s election of Group I,
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and the species of Compound (47), found on page 98 of the instant specification and in instant claim 65,
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in the reply filed on May 2, 2025 was acknowledged in a previous Office Action. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)). The requirement was deemed proper and therefore made FINAL in a previous Office Action.
Applicant’s claimed compound genus of elected
Group I had a number of formulae and variables and their permutations and combinations result in a vast number of compounds that are generically claimed. In an attempt to examine the full scope of compounds of elected Group I, over 72,700 Chemical Abstract Registry numbers were recovered in one database search alone. Therefore, the compounds of elected Group I have been examined according to MPEP §803.02.
The claims within elected Group I have been searched and examined to the extent that they are readable on the elected species of Compound (47). 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. See MPEP § 803.02. The subject matter of the expanded search and examination thus far, inclusive of the elected species of Compound (47), is as follows:
a compound of instant formula (I),
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wherein all variables are as defined in independent claim 1.
As a result of the current amendments to the claims per the Amendment filed February 2, 2026, the search and examination has been expanded beyond that which is indicated above. The entire scope of compounds of elected Group I embraced by instant formula (I) in currently amended independent claim 1 has now been searched and examined.
Further, the restriction between the products of formula (I) in Group I and the kit in Group II is hereby withdrawn. Therefore, the invention of Group II has now been rejoined (claim 83 and newly added claim 146).
Claims 66-69, 84, 86, 87, 98, 105-109, 111-116, 136-141 and 147-150 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 2, 2025. Claims 66-69, 105-109 and 111-116 were cancelled per the Amendment filed September 30, 2025.
Power of Attorney
Of note, there is not an attorney of record on file due to a lack of an official power of attorney of record. While a customer number has been provided on the Application Data Sheet (ADS) submitted
March 11, 2022, this is not the equivalent of a power of attorney or an authorization to act in a representative capacity. In order to expedite prosecution in the instant application, it is suggested that a power of attorney be filed as per MPEP §402 or MPEP §1807, or an Authorization to Act in a Representative Capacity be filed as per MPEP §403 in order for the Office to freely and openly discuss the merits of the case with the applicant's representative(s). Please refer to the MPEP or http://www.uspto.gov/patents/law/poafaqs.jsp#a if you have questions regarding the proper filing of a power of attorney."
Rejections made in the previous Office Action that do not appear below have been overcome by Applicant’s amendments to the claims. Therefore, arguments pertaining to these rejections will not be addressed.
However, as a result of the current amendments to the claims per the Amendment filed February 2, 2026, the following rejections now apply.
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, 79, 83, 117-123, 126, 129 and 133 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Yoshimoto et al. {US Patent 9,867,372} – who disclose, for example, Compound 107 (columns 143-144),
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{a compound of instant formula (I),
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494
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when
Y = CR13 and R13 = hydrogen;
q = 0;
X = CR13 and R13 = halogen;
Z3 = CR1 and R1 = hydrogen;
Z = CH;
Z2 = CR2 and R2 = hydrogen;;
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= a single bond;
A = O;
B = C(R3)(R4), R3 = hydrogen, and R4 = hydrogen;
Cy1 = aryl (i.e., phenyl);
n = 2;
one R9 = alkyl and the other R9 = -N(Ra)2;
the two instances of Ra are joined to form a substituted heterocyclyl; and
the molecular weight of the compound is 451.50 g/mol};
the compound of Chemical Abstracts Registry Number 1135350-05-8 {indexed in the Registry file on STN CAS ONLINE on April 16, 2009},
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520
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{a compound of instant formula (I),
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506
494
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when
Y = CR13 and R13 = hydrogen;
q = 0;
X = CR13 and R13 = hydrogen;
Z3 = CR1 and R1 = hydrogen;
Z = CH;
Z2 = CR2 and R2 = hydrogen;;
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= a single bond;
A = C(R19)2;
each R19 = hydrogen;
B = a single bond;
Cy1 = heterocyclyl;
n = 1;
R9 = unsubstituted heteroaryl; and
the molecular weight of the compound is 458.54 g/mol};
the compound of Chemical Abstracts Registry Number 1912402-91-5 {indexed in the Registry file on STN CAS ONLINE on May 17, 2016},
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402
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{a compound of instant formula (I),
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494
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when
Y = CR13 and R13 = hydrogen;
q = 0;
X = CR13 and R13 = hydrogen;
Z3 = CR1 and R1 = hydrogen;
Z = N;
Z2 = CR2 and R2 = hydrogen;
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= a single bond;
A = O;
B = a single bond;
Cy1 = aryl (i.e., phenyl);
n = 1;
R9 = -N(Ra);
each Ra = hydrogen; and
the molecular weight of the compound is 341.38 g/mol};
Hu et al. {WO 2014/169817 A1} – who disclose Compound HYH-029 on page 9 of the original document,
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{a compound of instant formula (I),
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494
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when
Y = CR13 and R13 = hydrogen;
q = 1;
X = CR13;
each R13 = unsubstituted alkyl;
Z2 = CR2 and R2 = hydrogen;
Z = CH;
Z3 = CR1 and R1 = hydrogen;
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= a single bond;
A = O;
B = C(R3)(R4);
R3 = hydrogen;
R4 = hydrogen;
Cy1 = aryl (i.e., phenyl);
n = 1;
R9 = substituted alkyl; and
the molecular weight of the compound is 439.52 g/mol};
and
e) Hadida et al. {US Patent 8,993,600} – who disclose Compound 79 in column 85,
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{a compound of instant formula (I),
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494
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when
Y = CR13;
q = 0;
X = CR13;
each R13 = hydrogen;
Z2 = CR2 and R2 = hydrogen;
Z = CH;
Z3 = CR1 and R1 = hydrogen;
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= a single bond;
A = NR16;
R16 = hydrogen;
B = C(=O);
Cy1 = carbocyclyl (i.e., cyclopropyl), which is substituted
(“carbocyclyl” can be unsubstituted or
substituted per the definition of carbocyclyl in the instant
specification in paragraph [0016] on page 7);
n = 0; and
the molecular weight of the compound is 436.48 g/mol}.
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, Hu et al. disclose pharmaceutical compositions comprising his compounds together with a pharmaceutically acceptable excipient (see the provided machine generated English translation of Hu et al. on page 2, under “Summary of the Invention”, 4th paragraph). Additionally, Hadida et al. disclose pharmaceutical compositions comprising his compounds together with excipients (column 176, lines 38-67). Hadida et al. also disclose kits comprising his compounds and instructions for using his compounds (column 179, line 54 through to column 180, line 3). Therefore, each of the above cited prior art anticipates the instant currently amended claimed invention.
Response to Arguments
Applicant’s arguments filed February 2, 2026 have been fully considered. Applicant argues that claim 1 has been amended to remove substituted or unsubstituted monocyclic heterocyclyl from the definition of the R9 variable and therefore, Compound 107 in Yoshimoto et al. {US Patent 9,867,372} does not anticipate the instant currently amended claimed invention.
In response, Compound 107 in Yoshimoto et al. is embraced by the currently amended claims, for instance, as shown above. Although Applicant deleted “substituted or unsubstituted monocyclic heterocyclyl” from the definition of the R9 variable in independent claim 1, the R9 variable can represent -N(Ra)2 in claim 1 where the two instances of Ra are joined to form a substituted heterocyclyl. Alternatively, see where variable n can represent zero and that the instant Cy1 variable can represent “aryl”. Note the definition of “aryl” in the instant specification in paragraph [0021] on page 10 where the “aryl” is defined as unsubstituted or substituted. The rejection is deemed proper and therefore, the rejection is maintained.
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 Compound (47), found on page 98 of the instant specification and in instant claim 65, is allowable over the prior art of record.
Claims 124, 125, 127, 128, 130-132, 135 and 142 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 65, 134 and 143-146 are allowed over the prior art of record.
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 11, 2026
Book XXVIII, page 143
Prosecution Insights