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 .
Election/Restrictions
Applicant's election without traverse of Group I, drawn to compound or composition, in the reply filed on 12/26/2023 is acknowledged. Claim 30 and 32 are withdrawn from further consideration pursuant to 37 CFR l.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim.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 12/26/2023.
Please note, for clarity of the record, Applicant’s election of the species of compound SMV-32- as described in the specification (page 17, line 10 to page 31, line 5) and as exemplified by claims 1-27.
During the course of examination, prior art was identified that relates to the elected subject matter. In the interest of compact prosecution, the prior art, Knabe, has been applied to demonstrate the non-allowability of the elected. However, Applicant amended the claim to overcome the rejection.
PNG
media_image1.png
233
662
media_image1.png
Greyscale
Pending claims 1,15-17, 19-25, 27 and 29 have been examined on the merits.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/14/2026 has been entered.
Withdrawn Rejections
The rejection of claims 1, 19-22, 24, 27 and 29 are rejected under 35 U.S.C. 102(a)(l) as being unpatentable over Uckun et al. US 6,638,939 is withdrawn in view of the amendments.
The rejection of claims 11-13, 15-17, 23, 25 under 35 U.S.C. 103 as being unpatentable over Uckun et al. US 6,638,939 as applied to claims 1, 19-22, 27 and 29 above, and further view of Popp et al. J. of the Amer Chem Soc, vol. 79, no. 14, July 1957, pp. 3773–3777, Patani et al. Chem Rev. 1996 Dec 19;96(8):3147-3176 is withdrawn in view of the amendments.
New Grounds of Rejection is necessitated Applicant’s IDS filed on 04/14/2026
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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, 19-22, 24-25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Beasley et al., J of Med Chem, vol. 7, no. 5, Sept. 1964, pp. 686–89 (IDS, 04/14/2026), Meanwell, Nicholas A. J of Med Chem, vol. 54, no. 8, Apr. 2011, pp. 2529–91 (“Meanwell”), Awuah et al., The J of Org Chem, vol. 75, no. 16, Aug. 2010, pp. 5627–34.
Regarding claim 1, 19-22, 24-25, and 27, Beasley (page 686) discloses papaverine and papaveraldine analogs, comparable to the instant claim. For example, Beasley (page 687, Table III) discloses R1 to R7 are independently selected from hydrogen, methyl and methoxy; A is absence; linker D is C=O; CH2; E is a carbon.
PNG
media_image2.png
489
1065
media_image2.png
Greyscale
Beasley, however, does not explicitly disclose Y is O.
Meanwell (page 2530, Table 1) teaches that -O-; carbonyl (-C=O) and methylene group (-CH2-) are considered classical bivalent biososteres, this suggests that they can occupy similar spatial positions within a molecular framework.
PNG
media_image3.png
118
332
media_image3.png
Greyscale
This steric similarity allows for preservation of molecular geometry, which may be critical in maintaining receptor binding or overall molecular conformation. This is further supported by Arwua (page 5630, Scheme) teaches isoquinoline ring, which is a core structure of papaverine, as in compound 19, wherein R4 and R5, or R5 and R6 combine together to which they attach to form a benzene ring. A POSITA would have been motivated also to substitute the
PNG
media_image4.png
166
514
media_image4.png
Greyscale
carbonyl (-C=O) from Arwua’s compound with an -O- liker to arrive at the claimed compound. Therefore, Meanwell’s disclosure represents predictable substitution of one known biosisoteric linker for another within the same class of papaverine derivative compounds. Therefore, a person of ordinary skill in the art (POSITA) would have been motivated to substitute (-C=O) or (-CH2-) with -O- to arrive at the claimed invention, because such substitution would maintain similar structural and functional characteristics while further expanding the known linker library for optimization of the papaverine compounds.
Subject Matter Free of the Art of Record
The subject matter of claims 15-17 are free of the art of record. The closest prior art is the Beasley et al., J of Med Chem, vol. 7, no. 5, Sept. 1964, pp. 686–89. While Beasley teaches discloses papaverine and papaveraldine analogs including linker D, however there is no motivation for a POSITA to modify the teaching of Beasley to arrive at the claimed compound. These claims are not allowable until the 103 rejection is overcome.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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, JAMES H 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.
/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights