DETAILED ACTION
This office action is in response to the Applicant’s filing dated March 20th, 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 371 of PCT/US22/25400 filed on April 19th, 2022; and has a PRO of 63/176,774 filed on April 19th, 2021.
Status of Claims
Claims 1, 8, 13, 42, 49 and 51-57 are pending in the instant application. Acknowledgement is made of Applicant’s remarks and amendments filed on March 20th, 2026. Acknowledgment is made of Applicant’s amendment of claims 1, 8, 49 and 57; and the cancelation of claims 2-3, 12, 50 and 58.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on March 20th, 2026 is acknowledged.
Claims 13, 49 and 51-56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 20th. 2026.
Applicant’s election without traverse of Compound 33b shown below in the reply filed on March 20th, 2026 is acknowledged:
PNG
media_image1.png
337
718
media_image1.png
Greyscale
Which is a compound of instantly claimed Formula (I) wherein R1 is C2 alkyl.
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 in/for/during this Office action.
Claims 1, 8, 42 and 57 read on the elected species and will be examined herein.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 8, 42 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over Mackall et al (WO 2020/092650 A1).
Regarding claims 1, 8, 42 and 57, Mackall teaches compound EB2P067 shown below (page 3, lines 23-24; page 15, third compound; page 39, lines 17-18; page 51, third compound; page 79, Example II, lines 13-14; page 92, claim 8, third compound):
PNG
media_image2.png
337
691
media_image2.png
Greyscale
Which is a compound that is very similar to instantly claimed Compound 33b. Mackall further teaches a pharmaceutical composition comprising EB2P067 and one or more pharmaceutically acceptable excipients (page 69, lines 3-4; page 105, claim 9). EB2P067 of Mackall differs structurally from instantly claimed Compound 33b only at the instantly claimed R1 position; wherein EB2P067 of Mackall has a C1 alkyl substituent at that position and instantly claimed Compound 33b has a C2 alkyl substituent at that position.
Mackall does not teach a compound with a C2 alkyl substituent at the instantly claimed R1 position.
MPEP 2144.09(II) states:
“Compounds which are homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).”
It would have been prima facie obvious to someone of ordinary skill in the art to perform a routine structural modification, adding a CH2 repeating unit at the R1 position, creating a homolog with a very similar structure to that of EB2P067 of Mackall, with a reasonable expectation of retaining similar chemical properties.
Taken together, all of this would result in the compound and composition of instant claims 1, 8, 42 and 57 with a reasonable expectation of success.
Conclusion
Claims 1, 8, 42 and 57 are rejected.
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 on (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
Prosecution Insights