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 .
DETAILED ACTION
Status of Application, Amendments, and/or Claims
The Information Disclosure Statement (IDS) filed 7 October 2024 has been entered.
Election/Restriction
This application contains claims directed to more than one species of the generic invention. These species are deemed to lack unity of invention because they are not so linked as to form a single general inventive concept under PCT Rule 13.1.
The species are as follows:
A. Wherein the channel peptide sequence comprises a structure of:
A-a) TQDYWEN (SEQ ID NO: 1)
A-b) CGEWIET (SEQ ID NO: 2)
A-c) TFKGWTI (SEQ ID NO: 25)
A-d) TSAGWDG (SEQ ID NO: 26)
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: claims 1, 2.
B. Wherein the hydrophobic domain comprises:
B-a) a hydrophobic peptide sequence (claim 9)
B-b) a species of type (I) (claim 10)
B-c) a species of type (II) (claim 11)
Applicant is required, in reply to this action, to elect a single species to which the claims shall be restricted if no generic claim is finally held to be allowable. The reply must also identify the claims readable on the elected species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered non-responsive unless accompanied by an election.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which are written in dependent form or otherwise require all the limitations of an allowed generic claim. Currently, the following claim(s) are generic: claim 7.
During a telephone conversation with Tani Chen on 12 June 2026, a provisional election was made for the species of: A-a) wherein the channel peptide sequence comprises a structure of TQDYWEN (SEQ ID NO: 1); and B-a) wherein the hydrophobic domain comprises a hydrophobic peptide sequence (claim 9). Affirmation of this election must be made by applicant in replying to this Office action.
Claims 5, 12-13, 19, 23, 26 and 28-46 are cancelled. Claims 1-4, 6-11, 14-18, 20-22, 24-25 and 27 are pending and under examination to the extent they read on the elected species. Claims 1-4, 6-9, 14-18, 20-22, 24-25 and 27 read on the elected species, and claims 10-11 are withdrawn as being drawn to non-elected species.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) 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.
Claim Objections
Claims 15 and 18 are objected to because of the following informalities:
Claim 15 should depend from claim 14, such that the phrase “a second terminus” recited in claim 16 (which depends from claim 15) is related to “a first terminus” recited in claim 14.
In claim 18, the phrase “a first species of peptide moiety” and “a second species of peptide moiety” should be “a first peptide moiety” and “a second peptide moiety”.
Appropriate correction is required.
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 27 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 27 recites “The composition of claim 7, wherein …the supramolecular nanostructure …”. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 1-4, 6-9, 14-18, 20-22, 24-25 and 27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claim 1 recites “A comprising: a peptide moiety comprising a channel or receptor peptide sequence and a hydrophobic domain connected to the peptide sequence.” The claims further define a peptide moiety comprising a peptide sequence having a structure TQDYWEN (SEQ ID NO: 1) or CGEWIET (SEQ ID NO: 2) and a hydrophobic domain connected to the peptide sequence. Depending claims limit that the peptide moiety is assembled into a supramolecular nanostructure, and an agent (tetrodotoxin and saxitoxin) is associated with the peptide moiety.
The claims are broad and encompass a genus of peptide moieties. For example, claim 1 encompasses any peptide sequence of a channel or receptor molecule connected to any hydrophobic domain; and claims 6 and 7 encompass a peptide sequence comprising the amino acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2 (both have 7 amino acids) and having flanking sequence(s) of any length. For the hydrophobic domain, while depending claim 9 limits that the hydrophobic domain comprises a hydrophobic peptide sequence, comprising between 3 and 10 hydrophobic amino acid residues selected from: alanine, isoleucine, leucine, methionine, phenylalanine, tryptophan, tyrosine, valine, glycine, and proline, the claims, however, do not specify the amino acid sequence or the length of the hydrophobic peptide sequence. The hydrophobic peptide sequence, as claimed, read on a peptide sequence, e.g., 100 amino acids in length with 3 alanine residues. The specification does not provide adequate written description and evidence of possession of these peptide moieties. What Applicant has described in the specification are peptide sequences set forth in SEQ ID NOs: 1, 2, 25 and 26 that can bind to a sodium channel blocker (e.g., tetrodotoxin or saxitoxin), wherein the peptide sequences are modified by connecting to a hydrophobic domain of 3-10 amino acids in length composed of alanine, isoleucine, leucine, methionine, phenylalanine, tryptophan, tyrosine, valine, glycine, and proline. The specification discloses that the modified peptide moieties are capable of assembling into nanofibres that facilitate specific binding with the sodium channel blocker and provide sustained release of the agent. The specification, however, fails to adequately describe the broad genus of the peptide moieties. There is no sufficient teaching regarding the correlation of structure and function. Urbach et al. (J. Am. Chem. Soc., 2025, Vol. 147: 24699−24707) teaches making stimulus-responsive peptide sequences for supramolecular assembly. Urbach et al. teaches that a single amino acid mutation in a peptide sequence would affect the secondary structure or oligomerization. In the absence of sufficient description of distinguishing identifying characteristics, the skilled artisan cannot envision the detailed structures of the encompassed genus of peptide moieties as claimed.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making of the claimed product, or any combination thereof. In this case, there is no sufficient teachings regarding the structural characteristics of the genus, nor the correlation of structure to function. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed structures of the encompassed genus of molecules, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that is part of the invention and reference to a method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF’s were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence.
Therefore, only the peptide sequences set forth in SEQ ID NOs: 1, 2, 25 and 26 that can bind to a sodium channel blocker, wherein the peptide sequences are modified by connecting to a hydrophobic domain of 3-10 amino acids in length composed of alanine, isoleucine, leucine, methionine, phenylalanine, tryptophan, tyrosine, valine, glycine, and proline, but not the full scope of the claimed peptide moieties, are adequately described in the disclosure.
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 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.
Claims 1-4, 6-9 and 14-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by George et al. (Ann. Neurol., 1992, Vol. 31:131-137).
George teaches the human skeletal muscle voltage-dependent sodium channel protein, which comprises a peptide sequence comprising SEQ ID NO: 1 and SEQ ID NO: 2 of the instant application (see sequence alignment). The human skeletal muscle voltage-dependent sodium channel protein contains a hydrophobic domain as presently claimed that is connected to the peptide sequences.
Therefore, anticipates the instant claims.
Conclusion
NO CLAIM IS ALLOWED.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Xiaozhen Xie, whose telephone number is 571-272-5569. The examiner can normally be reached on M-F, 8:30-5.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Vanessa L. Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/XIAOZHEN XIE/Primary Examiner, Art Unit 1674
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