DETAILED ACTION
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 .
Current Status
This action is responsive to the amended claims of 06/18/2026. Claims 1-15, 25, and 28-31 are pending. Claims 28-31 are new. Claims 16-20, 24, and 26-27 are canceled. Claims 2-14, 25, and 31 are withdrawn. Claims 1,15, and 28-30 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-15, 25, and 28-31) in the reply filed on 06/18/2026 is acknowledged. Applicant further elected compound 211
PNG
media_image1.png
162
200
media_image1.png
Greyscale
without traverse.
A search for compound 211 did not retrieve any prior art (see SEARCH 6 of the attached search notes). Compound 211 falls within Formula (Ia2) of claims 28-30. The search was expanded to Formula (Ia2); this search did not retrieve any prior art (see pg. 22-23 of the attached search notes).
The search was also extended to the core structure of the elected species:
PNG
media_image2.png
246
424
media_image2.png
Greyscale
wherein C* is a ring or chain node, A* is R1 is any atom other than H and is a ring or chain node, X1 is N, X4 is CH, X2 is CH, X3 is CR9, and R3-R9 are left undefined (open to any possible moiety). This search returned prior art for the following two species:
PNG
media_image3.png
195
353
media_image3.png
Greyscale
and
PNG
media_image4.png
208
406
media_image4.png
Greyscale
. These species read on claims 1 and 15.
Claims 2-14, 25, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/18/2026.
Further, Applicant voluntarily canceled the Group II claims 16-20, 24, and 26-27, directed to method of use of Group I. If applicant cancels all the claims directed to a nonelected process invention before rejoinder occurs, the examiner should not withdraw the restriction requirement. This will preserve applicant’s rights under 35 U.S.C. 121. See MPEP 821.04(b).
Priority
The effective filing date is 12/09/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/07/2023, 04/19/2024, 06/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the substitution specification filed on 01/26/2024 fails to incorporate the earlier amendments to the specification made on 12/07/2023; i.e., addition of cross-reference to related applications. Please provide a substitute specification which incorporates this amendment.
Appropriate correction is required.
Claim Objections
Claims 1, 15, and 28-30 are objected to because of the following informalities. Claim 1 requires the word “and” before 1) the final moiety from which R1 is chosen and 2) the final moiety from which Rg and Rh are independently selected from. Appropriate correction is required. Dependent claims 15 and 28-30 are similarly objected to since they do not rectify the underlying issue.
Note: withdrawn claim 31 lacks a claim status identifier. Please add the appropriate status identifier.
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 29-30 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 29 recites R8 is chosen from moieties including “4-10 membered heterocycloalkyl optionally substituted with one or two R10 and -N(R13)-(C=O)-R16”. This limitation can be interpreted in two alternative ways: 1) the 4-10 membered heterocycloalkyl is optionally substituted with R10 and the -N(R13)-(C=O)-R16 or 2) the -N(R13)-(C=O)-R16 moiety is an R8 moiety, not a substituent on the 4-10 membered heterocycloalkyl. The lack of punctuation after “R10”, such as a comma, leaves the limitation open to the double interpretation. It is unclear which interpretation is intended. Further, the first interpretation lacks sufficient antecedent basis in the claim since R8 as 4-10 membered heterocycloalkyl is only ever substituted by R10 and R10 cannot be -N(R13)-(C=O)-R16. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite. Dependent claim 30 is similarly rejected since it does not rectify the issue.
To overcome: please add a comma after R10; i.e., “4-10 membered heterocycloalkyl optionally substituted with one or two R10, and -N(R13)-(C=O)-R16”.
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 29-30 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. Since claim 29 has multiple interpretations (above ¶15), the embodiment wherein 4-10 membered heterocycloalkyl is substituted with -N(R13)-(C=O)-R16 is outside of the scope of Formula (I) in parent claim 1. Thus, claim 29 and its dependent claim 30 do not further limit the claims from which they depend. 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 (i.e., changing from AIA to pre-AIA ) 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 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by RENSLO (WO 2013/033037; cited IDS of 04/19/2024).
RENSLO teaches compound IND-0086056
PNG
media_image4.png
208
406
media_image4.png
Greyscale
(Pg. 294 Table 2) wherein X1 is N, X4 is CH, R3 is H, R1 is C1 alkyl (Me), R4-R5 are each H, R6-R8 are H, X2 is CH, X3 is CR9, and R9 is -O-C1alkyl-R12 and R12 is H (i.e., -O-C(H2)-H or -O-CH3). RENSLO teaches a pharmaceutical composition comprising a pharmaceutically acceptable excipient and a compound disclosed therein (including IND-0086056) (Pg. 10 ¶39).
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by ACS (American Chemical Society Chemical Abstracts Service, Registry No. 696627-97-1, entered 21 June 2004).
ACS teaches:
PNG
media_image5.png
515
576
media_image5.png
Greyscale
wherein X1 is N, X4 is CH, R3 is H, R1 is C1 alkyl (Me), R4-R5 are each H, R6-R8 are H, X2 is CH, X3 is CR9, and R9 is halogen (F).
Conclusion
Claims 1, 15, and 29-30 are rejected.
Claim 28 is objected to.
The close art for Formula (Ia2) of claims 28-30 is DICKSON (WO 2023/064493; effectively filed 13 Oct. 2022; cited IDS of 04/19/2024).
DICKSON teaches analogous compounds such as compound 408
PNG
media_image6.png
168
491
media_image6.png
Greyscale
(Pg. 631 Ex. 273); however, the annotated moieties differ from the instant. The instant R8 is not chosen from any moieties starting with an -O attachment and the instant R1 is not chosen from any moieties starting with a -S attachment. DICKSON teaches other analogous compounds such as compound 496
PNG
media_image7.png
154
415
media_image7.png
Greyscale
(Pg. 700 Ex. 316) which comprises an acceptable R1 (-N(Ra)(Rb) = -NH2); however, the R8 group still does not fall within the scope of instant Formula (Ia2). DICKSON does not teach any species analogous to instant Formula (Ia2) comprising acceptable R8 moieties. Thus, the art does not teach or suggest the compound of instant claims 28-30.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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 supervisor, Andrew Kosar can be reached at 571-272-0913. 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.
/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights