-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 .
Applicant’s response dated February 27, 2026 is acknowledged.
Priority
This application is a 371 of PCT/US2022/074903 filed on 08/12/2022, and claims benefit in provisional application 63/233,163 filed on 08/13/2021.
Claim Status
Claims 1-3, 5-9, 19, 21-23, 25, 34, 42, and 45-48 are pending. Claims 4, 10-18, 20, 24, 26-33, 35-41, 43, and 44 were canceled. Claim 1 was amended. Claims 3, 8, 9, 19, 21-23, 25, 34, 42, and 45-48 are withdrawn. Claims 1, 2, and 5-7 are examined.
Information Disclosure Statement
Non-patent literature references 1, 5, and 6 were not considered because the references are in foreign language and the applicant has not provided a translation nor a concise explanation of relevant. Additionally, citation for document 6 states pages 8-21, which is not correct because the document submitted by the applicant has pages 8-12.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1-3 and 5-8), drawn to a compound of formula I in the reply filed on February 27, 2026, is acknowledged.
Applicant’s election without traverse of the compound
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as the species of Formula I, is acknowledged.
Claims 1, 2, and 5-7 read on the elected species.
The requirement is still deemed proper and is therefore made FINAL.
Accordingly, claims 3, 8, 9, 19, 21-23, 25, 34, 42, and 45-48 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being withdrawn to a non-elected invention, and non-elected species of the invention, there being no allowable generic or linking claims.
Response to the restriction requirement of December 2, 2025 was timely filed.
Claims 1, 2, and 5-7 are examined on the merits.
Claim Rejections – 35 USC § 103
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.
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.
Claims 1, 2, and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Delehanty (US 2013/0129627 Published May 23, 2013 – of record in PTO-892 dated December 2, 2025).
The claims encompass a compound of formula
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.
Delehanty teaches a compound of formula
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wherein
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(Figure 10). The compound is formed by covalently attaching a palmitoyl group to diaminopropionic acid (Dap) residue (paragraphs 0098 and 0136). A synthetic palmitic acid group ((Pal)Dap) is for cell membrane association and insertion and vesicle escape (paragraph 0026). A vesicle escape domain preferably comprises a non-hydrolysable lipid moiety. Such a lipid moiety includes at least eight carbons. In one embodiment, the lipid moiety is palmitate (palmitic acid). One of ordinary skill in the art would recognize that another lipid moiety might be used to obtain the desired cell membrane association, insertion, and/or vesicle escape. Such moieties include stearic acid (paragraph 0121).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the compound “a” by replacing the palmitoyl group with stearoyl group, with a reasonable expectation of success because Delehanty teaches that stearic acid may be used instead of palmitic acid to obtain the compound. Stearic acid and palmitic acid are equally useful for making the compound and replacing one equivalent with another to obtain predictable results supports obviousness. It is apparent from paragraph 0121 that the source of the lipid moiety is a fatty acid. The skilled artisan would have recognized that -CH2-NH- segment in “a” was derived from NH2-CH2- portion of the Dap. The difference between the claimed compound and compound “a” as modified above is stereochemistry at the chiral center. The claimed enantiomer would have been obvious over the prior art enantiomer because the skilled artisan would have understood that diaminopropionic acid has two enantiomers and both would have been equally obvious. Figure 10 is the only place in Delehanty where stereochemistry of Dap is shown. The reference does not teach as to why the Dap having the stereochemistry depicted in Figure 10 was selected and there is no evidence that stereochemistry is critical. Similarly, instant application was reviewed and there is no evidence that the stereochemistry of the claimed compound is critical. In view of the lack of criticality, it would have been obvious to modify Delehanty by replacing the enantiomer of Dap shown in Figure 10 with the instantly claimed enantiomer to arrive at the claimed invention because the two enantiomers would have been equally obvious to use in Delehanty’s invention. The elected species is obvious over compound “a” having the palmitoyl group replaced with stearoyl group and stereochemistry of the claimed compound.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Alma - Pipic whose telephone number is (571)270-7459. The examiner can normally be reached M-F 9:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617
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