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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08/25/2025 has been entered.
Response to Arguments
Applicant’s amendments to claim 33, coupled with Applicant’s argument that, “The constructs of the present claims and constructs by Bach differ fundamentally, as the constructs of the present application associate two PICK1 binding peptides through non-covalent interactions, whereas the molecules generated by Bach comprises [sic] two PICK1 binding peptides which are linked together through covalent bonds.” (Remarks of 08/25/2025, p. 10), with respect to the rejection of claims 33, 35-37, 40, 42-44 and-48 have been fully considered and are persuasive. The rejection of the claims has been withdrawn.
Applicant’s arguments with regard to the Improper Markush Rejection of claims 34, 42 and 43, as set forth in the remarks of 06/24/2025, have also been further considered and are persuasive. On pages 8 and 9 of those remarks, Applicant has noted that leucine zippers such as GCN4-GS4-7P14P exists primarily as a dimer, despite the presence of two proline residues. Additionally, and regarding the grouping of the second polypeptides, Applicant has also noted that, based on Example 6 of the instant application, which provides data analyzing a number of different substitutions, and the prior art, which shows that removal of Z1 and/or Z2 would yield a structure belonging to the same class of PICK1 inhibitors with a common use. The rejection of the claims has been withdrawn.
Election/Restrictions
Claim 33 is allowable. The restriction requirement for a species of peptide and polynucleotide, as set forth in the Office action mailed on 03/20/2024, has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 12/21/2024 is partially withdrawn. Claims 38-39 and 41 , directed to species of the polynucleotide comprising various second polypeptide sequences, are no longer withdrawn from consideration because the claims require all the limitations of an allowable claim. However, claims 49-52, directed to an expression vector and polypeptide, remain withdrawn from consideration because the claims do not require all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Claim Rejections - 35 USC § 112(b)
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 38-39 and 41 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 33, from which the instantly rejected claims depend, recites, “a second polypeptide part comprising or consisting of an amino acid sequence” (emphasis added). As a result, some of the embodiments of claim 33 are limited to polypeptides consisting solely of specific sequences. For example, one embodiment of claim 33 is a polypeptide consisting of the amino acid sequence HWLKV.
However, claim 38 also recites the second polypeptide consisting of or comprising a sequence selected from three three-amino-acid peptides. Several embodiments of these peptides are mutually exclusive with the embodiments of claim 33. For example, one embodiment of claim 38 has an amino acid sequence Asp(D)-Ser(S)-Pro(P), according to the recited formula Φ-Υ-Ψ wherein Φ is Asp, Υ is the proteinogenic amino acid Ser, and Ψ is the hydrophobic acid Pro. These embodiments are mutually exclusive: the second polypeptide cannot simultaneously consist solely of the amino acid sequence HWLKV while also consisting solely of DSP. By the same logic, claims 39 and 41 recite second polypeptides which consist of certain sequences which are mutually exclusive with several embodiments of claim 33. For example, given the embodiment consisting solely of HWLKV, the second polypeptide cannot also consist solely of IETDV.
Conclusion
Claims 33, 35-37, 40, 42-44 and 48 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA M ZAHORIK whose telephone number is (703)756-1433. The examiner can normally be reached M-F 8:00-16:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Neil Hammell can be reached at (571) 270-5919. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA M ZAHORIK/ Examiner, Art Unit 1636
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