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 .
Restriction Requirement
Applicant’s election without traverse of Group I in the reply filed is acknowledged.
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.
Claim 13 is 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 13 recites the polymersome of claim 1, wherein the stapled peptide contains…” As there is stapled peptide in claim 1, there is insufficient antecedent basis for this term in claim 13.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5-8 and 13-18 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US 2010/0055189 to Hubbell (document already in record). Hubbell teaches a composition comprising a polymersome (abstract; paragraph 138) comprising: a plurality of amphiphilic block co-polymers (paragraphs 5 and 137), the particles comprise an amphiphilic block copolymer of at least one hydrophobic block and at least one hydrophilic block, wherein the block copolymer self-assembles in aqueous solutions to form the particles (paragraphs 14, 119, 206, and claim 19), and processed to achieve a nanoparticulate structure and dimensions (paragraph 101) Polymer vesicles may be formed from amphiphilic copolymers (paragraph 127) comprising a targeting moiety conjugated to a portion of the plurality of amphiphilic block copolymers on an exterior surface of the polymersome (paragraphs 88, 93, 95, and 138). This is a composition comprising a polymersome comprising: a plurality of amphiphilic block co-polymers; a targeting moiety conjugated to a portion of the plurality of amphiphilic block copolymers on an exterior surface of the polymersome; and an encapsulated cargo molecule. Further, Hubbell further teaches an antibody or antibody fragment (paragraph 93). Hubbell teaches wherein the targeting moiety binds to a cell surface protein (paragraph 74). Hubbell teaches the targeting moiety may comprise a cysteine linker (paragraphs 33, 49, 52, and 113). Hubbel teaches the encapsulated cargo comprises a therapeutic agent (paragraph 75). Hubbell teaches the amphiphilic block copolymer comprises a hydrophilic block comprising PEG (paragraph 80). The hydrophobic block copolymer comprises poly(propylene sulfide) (PPS) (paragraph 84). The amphiphilic block co-polymers comprises a linker between a hydrophobic block and a hydrophilic block, wherein the linker is a disulfide (paragraph 113). Compositions are taught comprising the polymersome and a carrier (paragraphs 6-22).
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 and 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over
US 2010/0055189 to Hubbell in view of WO 2019/133969 to Sloan-Kettering (document already in record). The relevant portions of Hubbell are given above.
Hubbell fails to teach wherein the cell surface protein is CD19.
Sloan-Kettering is in the field of polymersomes for delivery of genome editing agents/systems (page 95, lines 24-32) and teaches wherein a cell surface protein is CD19, wherein the cell surface protein can bind to a tumor antigen or a pathogen antigen, the protein comprises an extracellular
antigen-binding domain (page 2, lines 30-32), for enhancing the immune response toward cancers and pathogens (abstract).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to incorporate CD19 as the cell surface protein of Hubbell. The motivation for this would be to provide a cell surface protein useful in enhancing an immune response toward cancers and pathogens (Sloan-Kettering, Abstract).
Claims 1-3, 5-8 and 10-18 are rejected under 35 U.S.C. 103 as being unpatentable over US 2010/0055189 to Hubbell in view of Cromm (ACS Chemical Biology, 2015). The relevant portions of Hubbell are given above.
Hubbell fails to teach incorporation of hydrocarbon stapled peptides and hydrophobic stapled peptides into its polymersome.
Cromm teaches that hydrocarbon stapled peptides and hydrophobic stapled peptides are
are synthetic, helical peptide therapeutics effective in the treatment of cancer (abstract; page 1362, left column to page 1365, right column).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use hydrocarbon stapled peptides (hydrophobic stapled peptides) as the active agent Hubbell. The motivation for this would be that, by so doing, cancer may be treated.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
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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/PAUL W DICKINSON/ Primary Examiner, Art Unit 1618
April 4, 2026