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, 5, 14, 19, 28, 29, 31, 32, 41, 45, 46, 53 and 54 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 2-3, disclosed on page 232 of the instant specification,
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in the reply filed on March 5, 2025 is acknowledged. The requirement is still deemed proper and is therefore made FINAL.
Applicant’s claimed compound genus has a number of variables and their permutations and combinations result in a vast number of compounds that are generically claimed. In an initial attempt to examine the full scope of compounds currently claimed, over 31,100 Chemical Abstract Registry numbers were recovered in one database search alone.
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Therefore, the product claims in the instant application have been examined according to
MPEP §803.02.
The instant claims have been examined to the extent that they are readable on the elected species of Example 2-3. Since no prior art was found on the elected species, the examination was expanded within independent claim 1 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 of Example 2-3, is as follows:
a compound of instant formula (I),
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where
Z = a bond;
R4 =
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;
W1 = O; and
all other variables are as defined in
independent claim 1.
Claims embraced by the above identified expanded search and examination are claims 1, 14, 19, 28, 29, 31, 32, 41, 45, 46, 53 and 54.
Subject matter not embraced by the above identified search and examination and Claim 5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 5, 2026.
Interview
The Examiner called Applicant’s representative on Wednesday, March 25, 2026 @9:41 am and spoke to
Pamela A. Mingo, Ph.D. regarding the Response to the Restriction and the Preliminary Amendment filed on March 5, 2026. The Examiner stated that claim 20 had been previously cancelled per the Preliminary Amendment filed on July 25, 2025 but the Preliminary Amendment filed on March 5, 2026 lists claim 20 with text. Therefore, the Examiner requested that Dr. Mingo file a Supplemental Amendment that would list claim 20 as being cancelled instead of the Examiner sending out a non-compliant letter. Dr. Mingo stated that she would be willing to file a Supplemental Amendment that would correct the status of claim 20. The Examiner stated that the claim amendments filed March 5, 2026 would not be entered.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement filed on February 12, 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See paragraph [0003] on page 1 of the instant specification.
Claim Objections
Claim 1 is objected to because of the following informality: in claim 1, under the definition of R5, the closed parenthesis “)” after the substituent “NRaRb-C(O)-C1-C6alkyl” should be deleted (page 5, line 14 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, 14, 19, 28, 29, 31, 32, 41, 45, 46, 53 and 54 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 unclear because claim 1 does not define the R15 variable when R15 and R13 do not together form CH2 (see under the definition of variable W1 on page 4, line 13 of the page; and page 5, line 3 of the page). Therefore, claim 1 is indefinite.
Claims dependent on claim 1 which do not resolve the problem in claim 1 are also found indefinite.
Claim 14 lacks antecedent basis from claim 1 because there is no earlier recitation in claim 1 for the two rings found on line 1 of page 9 in claim 14 that are defining the R4 variable (which includes the definition of the W1 variable),
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See also the compound claimed on page 16, row 3, column 2, in claim 41 for same,
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. Therefore, claims 14 and 41 are indefinite.
Claim 14 is unclear because claim 14 states “the core of formula (I) or (II)” (see the last two lines of the claim). However, a formula (II) does not appear in claim 14 nor has a formula (II) been defined in claim 1 or in claim 14. Therefore, claim 14 is indefinite.
Claim 19 is unclear because variables Rc and Rd are found in a substituent in claim 19 (page 10, line 2 of the page) but neither of these variables have been defined in dependent claim 19 or in independent claim 1. Therefore, claim 19 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 14 and 41 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 14 fails to further limit claim 1 because claim 14 is broader in scope than claim 1. There are two rings found on line 1 of page 9 in claim 14 that are defining the R4 variable,
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but these two rings are not found under the definition of the R4 variable in claim 1. See also the compound on page 16, row 3, column 2, in claim 41 for same,
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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.
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, 14, 19, 28, 29, 31, 32, 41, 45, 46, 53 and 54 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Li et al. {WO 2017/172979 A1} – who disclose, for instance, Compound 152 on page 124,
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{a compound of instant formula (I),
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where
Z = a bond;
R1 = aryl (i.e., naphthyl), which aryl is substituted by hydroxy;
R2 = hydrogen;
R3 = halo (i.e., fluoro);
R7 = halo (i.e., chloro);
R4 =
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where
n’ =1,
R8 = hydrogen,
R8’ = hydrogen,
R9 = hydrogen,
R9’ = hydrogen,
R10 = hydrogen,
R10’ = hydrogen,
R13 = hydrogen,
R13’ = hydrogen, and
W1 = O;
X = O; and
R5 = NRaRbC3 alkyl,
where
Ra = C1 alkyl (i.e., methyl), and
Rb = C1 alkyl (i.e., methyl)};
O’Malley et al. {WO 2020/150113 A1} – who disclose, for instance, Example No. 120 on page 116,
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{a compound of instant formula (I),
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where
Z = a bond;
R1 = heteroaryl (i.e., pyrazolyl), which heteroaryl is unsubstituted;
R2 = hydrogen;
R3 = hydrogen;
R7 = hydrogen;
R4 =
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where
n’ =2,
R8 = hydrogen,
R8’ = hydrogen,
each R9 = hydrogen,
each R9’ = hydrogen,
R10 = hydrogen,
R10’ = hydrogen,
R13 = hydrogen,
R13’ = hydrogen, and
W1 = O;
X = NR16,
where R16 = hydrogen; and
R5 = hydrogen};
and
Zhang et al. {WO 2022/061251 A1} – who disclose, for instance, Compound P-0114 on page 164,
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{a compound of instant formula (I),
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where
Z = a bond;
R1 = aryl (i.e., naphthyl), which aryl is substituted by hydroxy;
R2 = hydrogen;
R3 = halo;
R7 = hydrogen;
R4 =
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,
where
n’ =1,
R8 = hydrogen,
R8’ = hydrogen,
R9 = hydrogen,
R9’ = hydrogen,
R10 and R13 together form C2 alkylene,
R10’ = hydrogen,
R13’ = hydrogen, and
W1 = O;
X = O; and
R5 = heterocyclylC1 alkyl, which heterocyclyl is substituted with C1 alkyl}.
Each of the above cited prior art disclose at least one compound that is embraced by the instant claimed invention as shown above. Further, each of Li et al. {paragraph [0028] on page 26 and paragraph [0060] on page 35}, O’Malley et al. {pages 22-23} and Zhang et al. {paragraphs [0276]-][0277] on page 145} disclose pharmaceutical compositions comprising their respective compounds together with a pharmaceutically acceptable excipient and that the pharmaceutical composition can be formulated for oral administration. Therefore, each of the above cited prior art anticipates 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.
Allowable Subject Matter
The elected species of Example 2-3, disclosed on page 232 of the instant specification, is allowable over the prior art of record.
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
April 1, 2026
Book XXIX, page 43
Prosecution Insights