DETAILED ACTION
Status of the Claims
Claims 142-161 are currently pending and are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/10/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Objection to the Abstract
Applicant is reminded of the proper language, content, and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. In certain patents, particularly those for compounds and compositions, wherein the process for making and/or the use thereof are not obvious, the abstract should set forth a process for making and/or use thereof. If the new technical disclosure involves modifications or alternatives, the abstract should mention by way of example the preferred modification or alternative.
The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
The abstract of the disclosure is objected to because it does not relate enough information about the disclosed invention(s) needed to "…disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details”, as per MPEP 608.01(b). Applicant is instructed to amend the abstract accordingly.
Specification
The disclosure is objected to because of the following informalities: The drawings show Fig. 16C, however, there is no mention of it in the Brief Description of the Drawings.
Appropriate correction is required.
Claim Interpretation
As per MPEP § 2111 and § 2111.01, during patent examination, the pending claims must be interpreted as broadly as their terms reasonably allow while being consistent with the specification. The words of a claim must be given their ‘plain meaning’ unless such meaning is inconsistent with the specification, wherein ‘plain meaning’ of a term means the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time. The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. Because applicant has the opportunity to amend the claims during prosecution, giving a claim its broadest reasonable interpretation will reduce the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Yamamoto, 740 F.2d 1569, 1571 (Fed. Cir. 1984)
Below are notes made by the examiner regarding claim interpretation of the most recent set of claims. Applicant is respectfully invited to comment on or dispute any of these statements.
Independent claim 142 recites a peptide that comprises a “first functional module”, a “second functional module”, and a “third functional module”, wherein these functional modules are reasonably functional limitations. As per MPEP § 2173.05(g), a “claim term is functional when it recites a feature ‘by what it does rather than by what it is’”. The same MPEP section states that “[t]here is nothing inherently wrong with defining some part of an invention in functional terms” and that “[a] functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used.” MPEP § 2114(II) further explains that "[A]pparatus claims cover what a device is, not what a device does" citing Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original), further stating that a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim, citing Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). In other words, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.
In the present case, the disclosure as originally filed does not provide any limiting definitions of the claimed functional modules beyond their function, such as by any structural limitation whatsoever. Therefore, any functional module of a peptide will reasonably read on the claim limitation if it also is able to perform the claimed function. That is, the claimed functional modules will reasonably encompass any peptide functional module that is able to perform the same function, regardless of its structure. Paragraph [173] of the specification states “[i]n the present application, the term ‘first functional module’ generally refers to a functional module of a peptide which may be able to bind to a nucleic acid” and therefore will be interpreted this broadly. Similarly, paragraph [174] states “[i]n the present application, the term ‘second functional module’ generally refers to a functional module of a peptide which is able to self-assemble” and paragraph [175] states “[i]n the present application, the term ‘third functional module’ generally refers to a functional module of a peptide which is able to facilitate nucleic acids to escape from an endosome.”
Claim Objections
Claim 160 is objected to as being dependent upon a rejected base claim, but would be free from the prior art if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b) -- Indefiniteness
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.
Claims 142-160 are 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 pre-AIA the applicant regards as the invention.
Claim 142 recites the limitation "the cell". There is insufficient antecedent basis for this limitation in the claim.
Claims 143-160 depend from claim 142 and are therefore similarly rejected.
Claim 146 recites the limitation "the beta sheets". There is insufficient antecedent basis for this limitation in the claim.
As per MPEP 2173: It is of utmost importance that patents issue with definite claims that clearly and precisely inform persons skilled in the art of the boundaries of protected subject matter. Therefore, claims that do not meet this standard must be rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph as indefinite. Further, as per MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. As currently written, the metes and bounds of the rejected claims are unascertainable for the reasons set forth above, thus the above claim(s) and all dependent claims are rejected under 35 USC 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections – 35 U.S.C. 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 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.
Ni et al.
Claims 142-146 and 148-159 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ni et al. (Angew. Chem. Int. Ed., 2020, 59:3578-3584, cited in IDS of 05/10/2024).
Regarding claim 142, Ni discloses a peptide, wherein said peptide comprises a first functional module, a second functional module and a third functional module, wherein said first functional module is able to bind to a nucleic acid, said second functional module is able to self-assemble outside the cell and disassemble inside the cell, and said third functional module is able to be protonated in endosome, wherein the peptide is able to form an assembly with nucleic acid (e.g., as per Fig. 1).
Regarding claim 143, Ni discloses the above peptide, wherein said first functional module comprises one or more lysine and/or arginine (e.g., as per Fig. 1).
Regarding claim 144, Ni discloses the above peptide, wherein said first functional module comprises K (e.g., as per Fig. 1).
Regarding claim 145, Ni discloses the above peptide, wherein said second functional module comprises a polypeptide for which the self-assembly propensity is able to be tuned by an intracellular or external stimuli (e.g., pH-responsiveness as per the Results and Discussion section pp. 3579-3583 and/or Fig. 1).
Regarding claim 146, Ni discloses the above peptide, wherein said second functional module is charged, and/or is less hydrophobic and/or is able to disassemble the beta sheets after encountering said intracellular stimuli (e.g., the β-sheet region as per Fig. 1).
Regarding claim 148, Ni discloses the above peptide, wherein said second functional module comprises at least one amino acid that comprises an imidazole side chain (e.g., histidine as per Fig. 1).
Regarding claim 149, Ni discloses the above peptide, wherein said second functional module comprises at least one amino acid that comprises a non-polar side chain (e.g., leucine as per Fig. 1).
Regarding claim 150, Ni discloses the above peptide, wherein said second functional module comprises one or more alanine, asparagine, cysteine, glutamine, histidine, isoleucine, leucine, methionine, phenylalanine, serine, threonine, tryptophan tyrosine, valine, S-Benzyl-L-cysteine (Cbzyi), t-butyl- s-s-cysteine (Cstu) and/or the combination thereof (e.g., as per Fig. 1).
Regarding claim 151, Ni discloses the above peptide, wherein said second functional module comprises a sequence as set forth in any one of SEQ ID NOs: 8-11 (e.g., SEQ ID NO: 8 as per Fig. 1).
Regarding claim 152, Ni discloses the above peptide, wherein said third functional module comprises at least one amino acid comprising an imidazole side chain (e.g., histidine as per Fig. 1).
Regarding claim 153, Ni discloses the above peptide, wherein said third functional module comprises one or more copies of histidine (e.g., as per Fig. 1).
Regarding claim 154, Ni discloses the above peptide, wherein said third functional module comprises H (e.g., as per Fig. 1).
Regarding claim 155, Ni discloses the above peptide, wherein said peptide comprises a fourth functional module, and said fourth functional module comprises a linker (e.g., linker as per Fig. 1).
Regarding claim 156, Ni discloses the above peptide, wherein said fourth functional module comprises 12-aminododecanoic acid (C12) (e.g., C12 linker as per Fig. 1).
Regarding claim 157, Ni discloses the above peptide, wherein said peptide comprises a fifth functional module, and said fifth functional module comprises a hydrophobic end moiety (e.g., hydrophobic amino acid(s) as per Fig. 1).
Regarding claim 158, Ni discloses the above peptide, wherein said peptide comprises a sixth functional module, and said sixth functional module is hydrophilic (e.g., hydrophilic segment as per Fig. 1).
Regarding claim 159, Ni discloses the above peptide, wherein said sixth functional module comprises GSP or D (e.g., GSPD as per Fig. 1).
Lo et al.
Claims 142-145, 147-148, 150, 152-155, and 158 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lo et al. (Biomaterials, 2008, 29:2408-2414).
Regarding claim 142, Lo discloses a peptide (e.g., as per Table 1), wherein said peptide comprises a first functional module, a second functional module and a third functional module, wherein said first functional module is able to bind to a nucleic acid (e.g., Tat portion of the peptide), said second functional module is able to self-assemble outside the cell and disassemble inside the cell (e.g., assemble with the DNA), and said third functional module is able to be protonated in endosome (e.g., histidine residues), wherein the peptide is able to form an assembly with nucleic acid (e.g., as per as per the section 3.1. Endosomolytic property of histidine homopeptide on pp. 2410-2412).
Regarding claim 143, Lo discloses the above peptide, wherein said first functional module comprises one or more lysine and/or arginine (e.g., as per Table 1 and/or Fig. 2).
Regarding claim 144, Lo discloses the above peptide, wherein said first functional module comprises K (e.g., the Tat peptide comprises RKKRRQRRRR as per the section 3.1. Endosomolytic property of histidine homopeptide on pp. 2410-2412).
Regarding claim 145, Ni discloses the above peptide, wherein said second functional module comprises a polypeptide for which the self-assembly propensity is able to be tuned by an intracellular or external stimuli (e.g., as per the section 3.1. Endosomolytic property of histidine homopeptide on pp. 2410-2412).
Regarding claim 147, Lo discloses the above peptide, wherein said second functional module comprises at least one amino acid that comprises a side chain which contains a disulfide bond (e.g., as per Fig. 2).
Regarding claim 148, Lo discloses the above peptide, wherein said second functional module comprises at least one amino acid that comprises an imidazole side chain (e.g., histidine as per Fig. 1).
Regarding claim 150, Lo discloses the above peptide, wherein said second functional module comprises one or more alanine, asparagine, cysteine, glutamine, histidine, isoleucine, leucine, methionine, phenylalanine, serine, threonine, tryptophan tyrosine, valine, S-Benzyl-L-cysteine (Cbzyi), t-butyl- s-s-cysteine (Cstu) and/or the combination thereof (e.g., histidine as per Fig. 2 and/or Table 1).
Regarding claim 152, Lo discloses the above peptide, wherein said third functional module comprises at least one amino acid comprising an imidazole side chain (e.g., histidine as per Fig. 2 and/or Table 1).
Regarding claim 153, Lo discloses the above peptide, wherein said third functional module comprises one or more copies of histidine (e.g., histidines as per Fig. 2 and/or Table 1).
Regarding claim 154, Lo discloses the above peptide, wherein said third functional module comprises H (e.g., as per Table 1 and/or Fig. 2).
Regarding claim 155, Lo discloses the above peptide, wherein said peptide comprises a fourth functional module, and said fourth functional module comprises a linker (e.g., peptide linkage as per Fig. 2 and/or Table 1).
Regarding claim 158, Lo discloses the above peptide, wherein said peptide comprises a sixth functional module, and said sixth functional module is hydrophilic (e.g., arginine and/or lysine as per Fig. 2 and/or Table 1).
Klein et al.
Claims 142-159 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Klein et al. (US PGPub 2023/0107579 A1, cited in IDS of 05/10/2024).
Regarding claim 161, Klein discloses a method of selecting a candidate peptide, wherein said method comprises preparing a library of said candidate peptide, wherein said candidate peptide comprises at least two kinds of functional module, and each said functional module is respectively selected from a corresponding library of functional module; wherein said corresponding library of functional module comprises at least two different functional modules sequences (e.g., selecting affinity reagents of the form αXβ as per the Abstract and throughout).
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
Prosecution Insights