Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 08 December, 2025. Claims 1, 2, 7, 8, 10, 11, 13-15, 17-19, 23, 25, 29, 30, 33, 34, 38 and 39 are pending in the instant application. Applicant’s election of Group I (claims 1, 2, 7, 8, 10, 11, 13-15, 17-19) is noted. 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 (M.P.E.P. § 818.03(a)). Accordingly, claims 23, 25, 29, 30, 33, 34, 38 and 39 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
37 C.F.R. § 1.98
The information disclosure statements filed 16 January, 2024, and 09 May, 2024, have been placed in the application file and the information referred to therein has been considered. Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement (e.g., see pages 40-42). 37 C.F.R. § 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and M.P.E.P. § 609.04(a), subsection I. states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
37 C.F.R. § 1.84
The drawings filed 07 October, 2022, have been reviewed and are acceptable.
35 U.S.C. § 102
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.
Claims 1, 2, and 7 are rejected under 35 U.S.C. § 102(a)(1) as being clearly anticipated by Shah et al. (2010). The claims are directed toward a nanostructure comprising a peptide amphiphile and a free peptide, wherein the peptide amphiphile comprises a hydrophobic tail, a structural peptide segment, and a charged peptide segment, and wherein the free peptide and the peptide amphiphile are non-covalently co-assembled within the nanostructure (claim 1). Claim 2 references a nanostructure wherein the structural peptide segment comprises V2A2 (SEQ ID NO: 51), V2A3 (SEQ ID NO: 52), V3A3 (SEQ ID NO: 53), or VEV, and the charged peptide segment comprises E, EE, EEE, EEEE (SEQ ID NO: 43), K, KK, KKK, or KKKK (SEQ ID NO: 44). Claim 7 references a free peptide with a charged head and β-sheet sequence.
Shah et al. (2010) disclose the generation of nanostructures comprising a peptide amphiphile (PA) and a free peptide. In particular, a peptide amphiphile comprising the following structure, HSNGLPLGGGSEEEAAAVVV(K)-CO(CH2)10CH3, was co-assembled with TGFβ-1. One weight percent solutions of PA were used for growth factor release studies by dissolving PA in aqueous solutions containing 1 μg/mL of TGFβ-1 (Materials and Methods, Peptide Synthesis and Purification and Growth Factor Release Studies, p. 3297). TGFβ-1 contains a number of charged residues near the amino terminus and folds into a β-sheet. Therefore, this teaching meets all of the claimed limitations.
35 U.S.C. § 112(a)
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Scope of Enablement
Claims 1, 2, 7, 8, 10, 11, 13-15, and 17-19 are rejected under 35 U.S.C. § 112(a), because the specification does not reasonably enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims. The claims are broadly directed toward a nanostructure comprising a peptide amphiphile and a free peptide, wherein the peptide amphiphile comprises a hydrophobic tail, a structural peptide segment, and a charged peptide segment, and wherein the free peptide and the peptide amphiphile are non-covalently co-assembled within the nanostructure.
The legal considerations that govern enablement determinations pertaining to undue experimentation have been clearly set forth. Enzo Biochem, Inc., 52 U.S.P.Q.2d 1129 (C.A.F.C. 1999). In re Wands, 8 U.S.P.Q.2d 1400 (C.A.F.C. 1988). Ex parte Forman 230 U.S.P.Q. 546 (PTO Bd. Pat. App. Int., 1986). The courts concluded that several factual inquiries should be considered when making such assessments including the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims. In re Rainer, 52 C.C.P.A. 1593, 347 F.2d 574, 146 U.S.P.Q. 218 (1965). The disclosure fails to provide adequate guidance pertaining to a number of these considerations as follows:
1) The claim breadth encompasses an inordinate number of PA and free peptide molecules. With respect to the PA molecules, the broadest claims simply require a hydrophobic tail, structural peptide segment, and charged peptide segment. With respect to the free peptide, no structural constraints are provided. Thus, the broadest claims fail to set forth any meaningful structural limitations and encompass a large genus of sundry PAs and free peptides.
2) The disclosure fails to provide adequate guidance with respect to the identification of suitable PAs and free peptides. As noted in item 1, the claims encompass an inordinate number of species. However, the disclosure fails to provide adequate guidance with respect to the identification of suitable hydrophobic structures and the identification of suitable structural and charged peptide sequences.
3) The disclosure only provides a limited number of working examples. Example 1 examined two short soluble free peptides in water, the β-amyloid (Aβ) peptide inhibitors LPFFD or KLVFF. These were combined with the PA E3A3V3(K)-CO(CH2)14CH3 (Example 1). The co-assembled PA peptide nanostructure displayed lower neurotoxicity as compared to the wildtype inhibitor. No other PA molecules were examined in this example. Example 2 looked ata short ACE2 peptide, SBP-1 (23-mer), and four PA sequences E3A3V3C16 (E3PA), E3A3V2FC16 (FE3PA), EVEVC16 (VEVEPA), and K3A3V3C1 (K3PA). The combination of E3PA appeared to display favorable characteristics. However, other PAs did not display favorable profiles because free peptide appeared to inhibit hydrogen bonding between the PA molecules thereby inhibiting nanostructure elongation.
4) The state-of-the-art suggests that generating suitable nanostructures utilizing PAs and free peptides can be a challenging process (Shah et al., 2010; Qui et al., 2023). For example, Shah et al. (2010) reported that adequate nanostructure assembly required the inclusion of a TGFβ-1 epitope in the PA to facilitate co-assembly. Qui et al. (2023) actually had to covalently bind the free peptide with the PA in order to achieve the desired therapeutic outcome. Clearly, suitable nanostructure assembly frequently requires modification of the PA to achieve the desired acticity.
Accordingly, when all the aforementioned factors are considered in toto, undue experimentation would be required to practice the invention in a manner commensurate in scope with the claims. Amendment of the claim language to support those specific examples provided in the specification would be appropriate.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 09 January, 2026