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 of Group I, claims 1-12, in the reply filed on 1/23/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1/23/2026.
Specification
The substitute specification filed 7/18/2023 has been entered.
Information Disclosure Statement
The IDS submitted 5/4/2023 cited the abstract of Lung et al. The IDS listed the wrong publication year. The examiner corrected this. The examiner hereby makes the full reference of record.
Claim Interpretation
Claim 10 recites “pharmaceutically innocuous” fillers. The specification does not define the metes and bounds of a “pharmaceutically innocuous” filler and this is not conventional claim language with respect to pharmaceutical compositions. “Pharmaceutically acceptable” is the more usual language. See at least paragraph [0099] of the substitute specification. The English language definition of innocuous is causing no injury or damage. In the absence of a more precise definition, the recitation of “pharmaceutically innocuous fillers” in claim 10 has been interpreted as meaning any pharmaceutically acceptable fillers.
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.
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 1-12 are rejected under 35 U.S.C. 103 as being obvious over Chyu et al. (of record as reference 1 on the 5/4/2023 IDS, Abstract 16640 at page e237, 3 December 2021, oral presentation 13 November 2021) in view of Chyu et al. (U.S. Patent Application Publication 2013/0230487), Chyu et al. (of record as reference 2 on the 5/4/2023 IDS, oral presentation 13 November 2021), and Joo et al. (of record, 2018).
Chyu et al.(December 2021) discloses administering the known apoB-100 peptide P210 complexed to peptide amphiphile micelle (PAM ) nanoparticles. They reduced atherosclerosis. This nanoparticle product would inherently contain the peptide of instant SEQ ID NO: 1.
Chyu et al. (November 2021) indicates on page 11 that the peptide amphiphiles in the P210-PAM nanoparticles were synthesized by conjugating peptides to the 1’-3’dihexadecyl N-succinyl-L-glutamate (diC16) hydrophobic tail and references Joo et al. (2018). This structure is encompassed by structure (II) in instant claims 4-5 and 9. See specification paragraph [0177] referencing Joo et al. and instant Figure 10.
Chyu et al. (U.S. Patent Application Publication 2013/0230487) is cited to establish that SEQ ID NO: 210 is identical to instant SEQ ID NO: 1. The peptide of SEQ ID NO: 210 is an immunogenic fragment of ApoB-100. The peptide of SEQ ID NO: 210 (referenced as p210 here and in the other Chyu et al. references in this ground of rejection) can be used as a vaccine. See at least abstract; claims; and paragraphs [0002, 0038, 0056, 0075-0075]. In addition, the reference discloses that peptide p210 can be administered with fillers or an adjuvant. See at least paragraphs [0072, 0118-0119]. See instant claims 10-11.
Joo et al. (2018) discloses cylindrical peptide amphiphile micelles (PAMs) that can be used for therapeutic applications. The lipophilic portion can comprise two linear alkyl chains such as diC16 tails. See at least page 2, second through fourth full paragraphs; Scheme 1; and section 2.1. (See instant claims 2-3.) The amphiphiles can be fluorescently labeled. See at least section 4.3. Joo et al. discloses coupling the peptide to the lipophilic portion at the N-terminus of the peptide. The structure of the diC16 tail is 1’-3’-dihexadecyl-N-succinyl-L-glutamate. See section 4.2. This structure is encompassed by structure (II) in instant claims 4-5 and 9. See specification paragraph [0177] referencing Joo et al. and instant Figure 10.
It would have been obvious to create a P210-PAM nanoparticle as taught by Chyu et al. (November 2021) as well as Chyu et al. (December 2021) by using the known P210 sequence of Chyu et al. (U.S. Patent Application Publication 2013/0230487) using the method of Joo et al. (and as suggested by Chyu et al. (November 2021)) thereby resulting in PAM nanoparticles containing instant SEQ ID NO: 1 and having two C16 linear alkyl tails (see claims 1-3). The PAM nanoparticle product would have been in a pharmaceutically acceptable medium for administration as taught by Chyu et al. (December2021) and Chyu et al. (November 2021) (see instant claims 7-8). It would have been further obvious to fluorescently label this product as taught by Joo et al. (see instant claim 6). With respect to claim 11, the intended use (“for eliciting an immune response in a mammal having an ischemic cardiovascular disease”) is taught by Chyu et al. (December 2021) and Chyu et al. (November 2021) and the recited adjuvant is optional and not required. Applicant is reminded that the claims are directed to a product and not a method. Nevertheless, Chyu et al. (U.S. Patent Application Publication 2013/0230487) suggests administering the immunogenic P210 peptide with a filler or adjuvant. It would have been obvious to use a filler or adjuvant with the P210-PAM nanoparticle. See instant claims 10-11. With respect to claim 12, Chyu et al. (2021) does not disclose the inclusion or administration of any MHC molecule with the PAM nanoparticle. With respect to instant claims 4-5 and 9, the diC16 structure meets structure (II) in instant claims 4 and 9 as set forth above.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Acar et al. (U.S. Patent Application Publication 2018/0066031) in view of Chyu et al. (U.S. Patent Application Publication 2013/0230487) and Joo et al. (of record, 2018).
Acar et al. discloses using peptide amphiphiles to form nanoparticles. A bioactive or therapeutic peptide is linked to a hydrophobic tail such as diC16. The peptide amphiphile can be fluorescently labeled. The hydrophobic tail can be linked to the N-terminus of the peptide. Pharmaceutically acceptable carriers such as liquid fillers can be used. See at least abstract; claims; Figure 1; Figures 3A and 3C; paragraphs [0008, 0016, 0042-0043, 0045, 0049, 0058, 0069, 0077, 019].
Chyu et al. establishes that SEQ ID NO: 210 is identical to instant SEQ ID NO: 1. The peptide of SEQ ID NO: 210 is an immunogenic fragment of ApoB-100 (i.e. a bioactive or therapeutic peptide). The peptide of SEQ ID NO: 210 (referenced as p210) can be used as a vaccine. See at least abstract; claims; and paragraphs [0002, 0038, 0056, 0075-0075]. In addition, the reference discloses that peptide p210 can be administered with fillers or an adjuvant. See at least paragraphs [0072, 0118-0119]. See instant claims 10-11.
Joo et al. (2018) discloses cylindrical peptide amphiphile micelles (PAMs) that can be used for therapeutic applications. The lipophilic portion can comprise two linear alkyl chains such as diC16 tails. See at least page 2, second through fourth full paragraphs; Scheme 1; and section 2.1. (See instant claims 2-3.) The amphiphiles can be fluorescently labeled. See at least section 4.3. Joo et al. discloses coupling the peptide to the lipophilic portion at the N-terminus of the peptide. The structure of the diC16 tail is 1’-3’-dihexadecyl-N-succinyl-L-glutamate. See section 4.2. This structure is encompassed by structure (II) in instant claims 4-5 and 9. See specification paragraph [0177] referencing Joo et al. and instant Figure 10.
It would have been obvious to create a peptide amphiphile nanoparticle as taught by Acar et al. using the known p210 sequence of Chyu et al. using the method of Acar et al. and Joo et al. thereby resulting in peptide amphiphile (PAM) nanoparticles containing instant SEQ ID NO: 1 and having two C16 linear alkyl tails (see claims 1-3). It would have been further obvious to formulate the PAM nanoparticle product in a pharmaceutically acceptable medium for administration as taught by Acar et al. (see instant claims 7-8). It would have been further obvious to fluorescently label this product as taught by Acar et al. and Joo et al. (see instant claim 6). With respect to claim 11, the recited adjuvant is optional and not required. The recited intended use (“for eliciting an immune response in a mammal having an ischemic cardiovascular disease”) does not add any additional structural feature and would have been a characteristic of the suggested product as evidenced by the instant specification. Applicant is reminded that the claims are directed to a product and not a method. The product is suggested by the prior art. Chyu et al. (U.S. Patent Application Publication 2013/0230487) suggests administering the immunogenic p210 peptide with a filler or adjuvant. It would have been obvious to use a filler or adjuvant with the p210-PAM nanoparticle. See instant claims 10-11. With respect to claim 12, none of Acar et al., Chyu et al., or Joo et al. disclose the inclusion or administration of any MHC molecule with the PAM nanoparticle. With respect to instant claims 4-5 and 9, the diC16 structure meets structure (II) in instant claims 4 and 9 as set forth above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIANNE P ALLEN whose telephone number is (571)272-0712. The examiner can normally be reached 7:00-3:30 EST Monday-Friday.
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/Marianne P Allen/Primary Examiner, Art Unit 1647
mpa
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