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 117-152 are pending in the instant application.
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 amendments to the claims per the Amendment filed February 2, 2026, the search and examination was expanded beyond that which is indicated above to the point wherein the entire scope of compounds of elected Group I embraced by instant formula (I) in independent claim 1 has been searched and examined.
Further, the restriction between the products of formula (I) in Group I and the kit in Group II was withdrawn in the previous Office Action. Therefore, the invention of Group II has now been rejoined (claim 83 and 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. Claims 84, 86, 87, 98, 136-141 and 147-150 are still currently pending.
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 June 15, 2026, the following rejections now apply.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 79, 83, 117-129, 131-133, 142, 151 and 152 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a new matter rejection. No persuasive support is found in the original specification or the originally filed claims for the amendment to the definition of variable R9 as found in independent claim 1. Applicant generically states “Support for the claim amendments can be found in the present Application as originally filed” in the Remarks section filed
June 15, 2026 on page 40. However, Applicant should have specifically pointed out the support in the original disclosure {page number(s) and paragraph 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 number(s), paragraph number(s) and claim number(s) are insufficient. See MPEP §714.02 and MPEP §2163.06(I). Therefore, claim 1, and claims dependent on independent claim 1 which do not resolve the written description problem in claim 1, lack written description as such.
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, 133, 151 and 152 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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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)C(=O)N(Ra) 2;
the two instances of Ra each attached to the nitrogens are joined to
form a heterocyclyl and
the other Ra = unsubstituted alkyl; 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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{a compound of instant formula (I),
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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, which is substituted,
(see the definition of “heterocyclyl” in paragraph [0018] on page 8 of the
instant specification, wherein “heterocyclyl” is defined as unsubstituted or
substituted; and paragraphs [0026]-[0028] on pages 12-16);
n = 1;
R9 = hydrogen; 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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{a compound of instant formula (I),
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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, substituted,
(see the definition of “aryl” in paragraph [0021] on page 10 of the
instant specification, wherein “aryl” is defined as unsubstituted or
substituted; and paragraphs [0026]-[0028] on pages 12-16);
n = 1;
R9 = hydrogen; and
the molecular weight of the compound is 341.38 g/mol};
and
d) 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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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; and
paragraphs [0026]-[0028] on pages 12-16);
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. 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 June 15, 2026 have been fully considered.
Applicant argues that the definition of the R9 variable in independent claim 1 has been amended 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. Alternatively to that which is shown above, see where variable n can represent zero or one, variable R9 can represent hydrogen, and that the instant Cy1 variable can represent “aryl”. Per the definition of “aryl” in the instant specification in paragraph [0021] on page 10, the “aryl” (such as a phenyl) is defined by Applicant as being unsubstituted or substituted. See also paragraphs [0026]-[0028] on pages 12-16 of the instant specification. Note too that Yoshimoto et al. disclose more than one anticipatory compound. The anticipatory rejection of the currently amended claims over the disclosure in Yoshimoto et al. is deemed proper and therefore, the rejection is maintained.
Applicant argues that the definition of the R9 variable in independent claim 1 has been amended and therefore, the compound of Chemical Abstracts Registry Number 1135350-05-8 does not anticipate the instant currently amended claimed invention.
In response, it is disagreed that the compound of Chemical Abstracts Registry Number 1135350-05-8 does not anticipate the currently amended claimed invention. Applicant has defined terms such as “aryl”, “carbocyclyl”, “heterocyclyl”, etc. in the instant specification as embracing both unsubstituted and substituted. See also paragraphs [0026]-[0028] on pages 12-16 of the instant specification. As shown in the above anticipatory rejection, the compound of Chemical Abstracts Registry Number 1135350-05-8 is embraced by the currently amended claims when:
Cy1 represents heterocyclyl, substituted (see
definition of “heterocyclyl” in paragraph
[0018] on page 8 of the instant specification,
wherein “heterocyclyl” is defined as
unsubstituted or substituted);
n is 1; and
R9 represents hydrogen.
See also paragraphs [0026]-[0028] on pages 12-16 of the instant specification. The anticipatory rejection of the currently amended claims over the compound of Chemical Abstracts Registry Number 1135350-05-8 is deemed proper and therefore, the rejection is maintained.
Applicant argues that the definition of the R9 variable in independent claim 1 has been amended and therefore, the compound of Chemical Abstracts Registry Number 1912402-91-5 does not anticipate the instant currently amended claimed invention.
In response, it is disagreed that the compound of Chemical Abstracts Registry Number 1912402-91-5 does not anticipate the currently amended claimed invention. Applicant has defined terms such as “aryl”, “carbocyclyl”, etc. in the instant specification as embracing both unsubstituted and substituted. See also paragraphs [0026]-[0028] on pages 12-16 of the instant specification. As shown in the above anticipatory rejection, the compound of Chemical Abstracts Registry Number 1912402-91-5 is embraced by the currently amended claims when:
Cy1 represents aryl (i.e., phenyl), which is
substituted, {see the definition of “aryl” in
paragraph [0021] on page 10 of the instant
specification, wherein “aryl” is defined as
unsubstituted or substituted};
n is zero or one; and
R9 represents hydrogen.
See also paragraphs [0026]-[0028] on pages 12-16 of the instant specification. The anticipatory rejection of the currently amended claims over the compound of Chemical Abstracts Registry Number 1912402-91-5 is deemed proper and therefore, the rejection is maintained.
Applicant argues the anticipatory rejection of the claims over Hadida et al. {US Patent 8,993,600}. Applicant argues that claim 1 does not encompass cited Compound 79 which includes “
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” as the moiety corresponding to the instant variable R9 in the instant claims. Applicant argues that “
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” is not a substituted or unsubstituted phenyl.
In response, all of Applicant’s arguments have been considered but have not been found persuasive. The anticipatory compounds disclosed in the prior art can sometimes be embraced by instant currently amended independent claim 1 in multiple ways. Compound 79 in Hadida et al. is embraced by instant currently amended independent claim 1 when:
Cy1 represents carbocyclyl (i.e., cyclopropyl),
which is substituted,
(see the definition of “carbocyclyl” in the instant specification in paragraph [0016] on page 7);
n is zero or one; and
R9 represents hydrogen.
Alternatively, Compound 79 in Hadida et al. is embraced by instant currently amended independent claim 1 when:
Cy1 represents carbocyclyl (i.e., cyclopropyl),
which is unsubstituted;
n is one; and
R9 represents a substituted phenyl,
{see paragraphs [0026]-[0027] on pages 12-13 of
the instant specification which disclose
possible substituents on an “aryl” (i.e., a
phenyl – paragraph [0021]) such as an -ORaa
group, in which two -ORaa groups can be
substituted on the “aryl” (i.e., a phenyl) and
that two Raa groups can be joined to form a
3-14 membered heterocyclyl}.
See also paragraphs [0026]-[0028] on pages 12-16 of the instant specification. For all the reasons given above, the anticipatory rejection of the currently amended claims over Compound 79 in Hadida et al. 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 130 and 135 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.
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 84, 86, 87, 98, 136-141 and 147-150 drawn to an invention nonelected with 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
June 26, 2026
Book XXVIII, page 143
Prosecution Insights