DETAILED ACTION
This office action is in response to the Applicant’s filing dated September 10th, 2026.
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 .
Priority
This application is a CON of 19/094,924 filed on March 30th, 2025; a CON of PCT/CN2023/122129 filed on September 27th, 2023; and claims benefit of foreign priority of CN202311247776.9 filed on September 26th, 2023, CN202310721348.9 filed on June 16th, 2023, CN202310258788.5 filed on March 16th, 2023, CN202310080287.2 filed on January 17th, 2023, CN202211583282.3 filed on December 9th, 2022 and CN202211208795.6 filed on September 30th, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 24-46 are pending in the instant application. Acknowledgement is made of Applicant's remarks filed on September 10th, 2026.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on September 10th, 2026 is acknowledged. Claims 44-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant's election with traverse of the compound of Example 105 shown below in the reply filed on September 10th, 2026 is acknowledged.
PNG
media_image1.png
570
549
media_image1.png
Greyscale
Example 105 is located on page 248 of the Specification, and is the 10th compound listed in claim 41 on page 9. Applicants state Example 105 is a species of genus Formula (I), wherein R1 and R1’ together form an intracyclic bridging -CH2CH2-; wherein R2 is H; wherein R3 is F; wherein G is N; wherein Y is O; wherein M is N; wherein Z is C; wherein k is 0; wherein B is
PNG
media_image2.png
118
79
media_image2.png
Greyscale
; wherein R5 is F; wherein R6 is ethynyl; wherein R11 is methyl; wherein m is 1; wherein R12 is difluoromethyl; wherein R13 is methyl; and wherein R14 is H, and wherein t is 2.
The traversal is on the grounds that the Office is prohibited by judicial precedent from using an intra-claim restriction requirement under 37 C.F.R. § 1.141 to compel Applicants to break a single broad claim into claims of lesser scope. This is not found persuasive because 37 C.F.R. § 141 is directed to national stage applications filed under 35 U.S.C. § 371, whereas the instant application is filed under 35 U.S.C. § 111(a) and thus is not applicable.
The requirement is still deemed proper and is therefore made FINAL.
Claims 29-32, and 39-40 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. Applicant timely traversed the election requirement in the reply filed on September 10th, 2026.
A prior art search was conducted for the elected species.
This search retrieved prior art.
Therefore, the Examiner’s search will not be extended unnecessarily to additional species of genus Formula (I) in/for/during this Office action.
Claims 24-28, 33-38 and 41-43 read on the elected species and will be examined herein for prior art purposes.
Claim Objections
Claim 24 is objected to because of the following informalities: In claim 24, at the bottom of page 1 the claim recites “Error! Unknown document property name.”; and on page 2 in line 4 the claim recites “W is selected H, -C1-6 alkyl…” but should read “W is selected from H, -C1-6 alkyl…”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 24-25 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.
Regarding claim 24, on page 1 in the last line, the claim recites variables k and Z in Formula (I), however no definition is explicitly recited for the variables k and Z in the claim. As such, the metes and bounds of the claim are unclear.
In the interest of compact prosecution, the Examiner will proceed as if k is 0 and Z is C for prior art purposes.
Regarding claim 25, on page 3 in line 1 spanning into line 2, the claim recites “wherein R7 and R8 are each independently selected from H, or one is H and the other is halogen, and W is H.” This language renders the claim unclear as to whether the applicant intended the closed group of alternatives for R7 and R8 to be further narrowed to H only, or to H and halogen.
In the interest of compact prosecution, the Examiner will proceed as if the claim recites “wherein R7 and R8 are each independently selected from H and halogen; and W is H.”
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 24-28, 33-38 and 41-43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dai et al (US 2023/0357233 A1).
Regarding claims 24-28, 33-38 and 41-43, Dai teaches the compound below:
PNG
media_image1.png
570
549
media_image1.png
Greyscale
Which is a compound of Formula I-1-A of Dai (page 6, left column, first sub-formula of Formula I listed); wherein R1 is OR20, wherein R20 is C1 alkylene-R101 (page 7, right column, paragraph [0051]); wherein R101 is a monocyclic 6 membered heterocyclic ring with 1 N heteroatom, specifically piperidine, substituted with C1 alkyl at the 1 and 3 positions and difluoromethyl at the 4 position (page 9, left column, paragraph [0056]); wherein R2 is
PNG
media_image3.png
129
67
media_image3.png
Greyscale
(page 22, left column, second row, middle compound); and wherein R3 is
PNG
media_image4.png
132
155
media_image4.png
Greyscale
(page 29, right column, third row from bottom, right compound). This is the same compound as the instantly elected compound of Example 105. Dai further teaches that compounds of Formula I-1-A can be used in pharmaceutical compositions further comprising a pharmaceutically acceptable excipient (page 104, right column, paragraphs [0348-0349]).
Thus, the teachings of Dai anticipate the compounds and pharmaceutical composition of instant claims 24-28, 33-38 and 41-43.
Conclusion
Claims 24-28, 33-38 and 41-43 are rejected.
Claim 24 is objected to.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER L JOHNSON whose telephone number is (571)272-1672. The examiner can normally be reached Monday - Friday 08:00AM - 5:00PM EST with Flex on Fridays.
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, Renee Claytor can be reached at (571) 272-8394. 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.
/C.L.J./Examiner, Art Unit 1691 /RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
