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
The Response of 11 Feb. 2026 has been entered.
Claims 1-20 are currently pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group I, claims 1-7, and the species of: SEQ ID 3 as the GC1 polypeptide; both conjugated to CPP and derivatized; FITC as the derivative; SEQ ID 8 as the CPP; N-terminal as the CPP linkage; and cancer as the disease in the reply filed on 11 Feb. 2026 is acknowledged. In the interest of compact prosecution, the species election requirements with respect to whether the GC1 polypeptide is conjugated and/or derivatized and species of derivatizations are withdrawn. Applicant further indicated SEQ ID 5 as an elected species of construct, but the Restriction Requirement of 14 Jan. 2026 does not include a species election requirement for species of constructs.
Claims 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 11 Feb. 2026.
Claims 1-7 are considered here with respect to the elected species of SEQ ID 3 as the GC1 polypeptide; SEQ ID 8 as the CPP; N-terminal as the CPP linkage; and cancer as the disease.
Allowable Subject Matter
The species of construct defined by SEQ ID 5 (comprising the CPP of SEQ ID 8 fused to the GC1 polypeptide of SEQ ID 3, and an FITC derivatization) is free of the prior art. Said construct is recited as an optional feature of claim 6(c).
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.
Claims 3-6 are rejected under 35 U.S.C. 112(b) 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.
Claims 3-5 recite various options (e.g., in claim 3, "the fragment comprises 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, or 20 amino acid residues") followed by an optional limitation reciting one of the options (e.g., in claim 3, "optionally wherein the fragment comprises 11 amino acid residues"). Since the optional feature is already optional in the first recitation, it is unclear how the "optionally" limitation further limits the claims.
Claim 6 recites "the construct shares at least 85% sequence identity with any of SEQ ID NO:5". It is unclear what is meant by "any of SEQ ID NO:5" (e.g., it is unclear whether Applicant intends the recitation to include subfragments of SEQ ID 5).
Claim Rejections - 35 USC § 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 1-7 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Kraehling et al., PloS one 6.9 (2011): e25772.
Regarding claims 1 and 2, Kraehling teaches constructs comprising a soluble guanylyl cyclase (GC1) polypeptide (either the full-length human α1 polypeptide or a fragment lacking the N-terminal residues 1-258) fused/conjugated to the fluorescent protein ECFP or EYFP (p. 8, under Cloning of a1WT and C-a1 fused with fluorescent proteins for determination of fluorescence lifetime; p. 9, under Exchange of ECFP and EYFP). The GC1 polypeptides comprise SEQ ID 3 (RKINVSPTTYR) (Fig. S1).
Regarding the recitation that "the polypeptide is further derivatized", the term "derivatized" is not expressly defined in the specification and is given its broadest reasonable interpretation consistent with the specification (see MPEP 2111). The term "derivatized" is construed herein to include conjugation (claim 2 recites "wherein the derivatization of the polypeptide comprises conjugation to a fluorophore"). Moreover, such conjugation is construed as including N-terminal and/or C-terminal polypeptide fusion (claim 6 recites that the CPP can be conjugated at the N-terminus or C-terminus, and that the linkage can be an amide bond). Kraehling teaches a GC1 polypeptide comprising SEQ ID 3 fused to a fluorophore (ECFP) and thus meets the limitations of the claim.
Regarding claim 3, Kraehling teaches that the GC1 polypeptides comprise residues 581-635 of GC1 (recited in claim 1) and all fragments thereof (Fig. S1).
Regarding claim 4, the transitional phrase "consisting essentially thereof" limits the scope of a claim to the specified materials or steps and those that do not materially affect the basic and novel characteristic(s) of the claimed invention (MPEP 2111.03, III.). The instant specification states that the compositions of the invention are "useful for inhibiting the interaction and/or complex formation of GC1 and Trx1" (Published Spec. US20240301386, [0006]) and such functionality is considered as comprising the basic and novel characteristic(s) of the claimed invention. The specification further states that full-length GC1 has the ability of binding to and forming a complex with Trx1 (Spec., [0005]). Thus, the constructs of Kraehling would be capable of forming such complexes and competing with native GC1 to inhibit the interaction and/or complex formation of GC1 and Trx1.
Regarding claims 5-6, the claims further limit the CPP aspect of claim 1 (element (a) in claim 1), which is optional (claim 1 states that at least one of (a) or (b) applies, and Kraehling teaches element (b)).
Regarding claim 7, the specification states that the “pharmaceutically acceptable carrier” can include a pharmaceutically acceptable salt or water (Spec., [0042]). Kraehling teaches cell culture compositions comprising the GC1-fluorophores constructs, which would include at least water and various physiological salts (p. 10, under Fluorescence Lifetime Imaging (FLIM) using a confocal laser scanning microscope).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657