DETAILED ACTION
Status of Application
The amendments and response filed 23 April 2026 are acknowledged and have been considered in their entireties. Claims 2-4 and 7 are cancelled; claims 10-12 are new and commensurate in scope with the previously examine claims 6-9. Thus, claims 1, 5-6 and 8-12 are pending; Claims 1 and 5 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 6 and 8-12 are subject to examination on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 21 April 2026 has been considered by the examiner. See initialed and signed PTO/SB/08.
Withdrawal of Previous Rejection(s)
The rejection of claims 6-7 under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al. (Acta Pharmcologica Sinica, 2018 – cited previously) is withdrawn in view of the amendments to claim 6 requiring the foreign substance being a nucleic acid or a drug. Ma et al. teaches the attachment to a dye.
The rejection of claim 6 under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Reed et al. (US 20030175819 – cited previously) is withdrawn in view of the amendments to claim 6 requiring the foreign substance being a nucleic acid or a drug. Reed et al. teaches the attachment to the polypeptide GFP.
Maintained Rejection – Modified in View of Amendments
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 6 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Nanotech., Biology, and Medicine - 2020 – cited on PTO-892 11/06/2025).
Li et al. teach:
Li et al. teach fusion proteins of humanin comprising the amino acid sequence MAPRGFSCLLLLTSEIDLPVKRRA (SEQ ID NO: 1) fused to an elastin-like polypeptide (See ELP gene and construction, and ELP expression and purification, Methods, p. 2), wherein said construct is transported into retinal epithelial cells (RPE) – See Cellular update assay pp. 3-4; also See Table 1 and Methods on p. 2, and Figure 1a.
Given the specification is void of any kind specific definition of what constitutes a “drug”, the fusion with ELP and its potential therapeutic effects on retinal cells meets the limitations of “a drug”. It is further noted, however, that in instant paragraph 0068 (PG-Pub) it is acknowledged that “peptide drugs” do exist.
With regard to claims 8-11, it is noted the last limitation of claim 10 recites “at least one amino acid residue of the foreign substance introduction construct is converted to an amide” is an inherent feature of every single peptide and protein because amide groups containing a nitrogen atom bonded directly to a carbonyl group is the principal building block of protein. Every single peptide and protein comprise amides once two or more amino acids are linked together. As such, inherently the teachings of CN101144080A meets this limitation
Claim(s) 6 and 8-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN101144080A, published 2008; cited on PTO-892 of 01/29/2026 – Chinese and English language versions both provided.
CN101144080A teaches at in section 1 under “Contents of the invention”:
“According to the primary structure of human VIP and HN, a tandem co-expression fusion protein was designed. The N-terminus of the VIP position, the C-terminus of the HN position, the middle is a self-designed connecting small peptide, the length is 13 amino acids, and the two ends are double basic amino acids. In consideration of the need for maturation of the fusion protein, an enterokinase recognition sequence (-DDDDK-) was added before VIP.”
Claim 5 specifically describes the fusion protein, including the DDDDK, VIP (underlined), 13 amino acid intervening peptide; and humanin comprising MAPRGFSCLLLLTSEIDLPVKRRA (bold), going from N-terminus to C-terminus:
DDDDKHSDAVFTDNYTRIRKQMAVKKYLNSILNRRGGAGIVGGSRKMAPR GFSCLLLLTSEIDLPVKRRA
Thus, the CN101144080A reference teaches a precursor comprising the peptide drug VIP construct fused to the N-terminus of humanin comprising instant SEQ ID NO: 1. However, as noted it is a precursor construct and once treated with enterokinase, which happens after enterokinase treatment in Section 4.1, then the construct inherently comprises a fusion polypeptide having a mature polypeptide located N-terminally to the humanin sequence of SEQ ID NO: 1.
Given the specification is void of any kind specific definition of what constitutes a “drug”, the fusion with VIP and its potential therapeutic effects for Alzheimer’s treatment (See Section 1.1) meets the limitations of “a drug”. It is further noted, however, that in instant paragraph 0068 (PG-Pub) it is acknowledged that “peptide drugs” do exist. The VIP peptide as taught is deemed a peptide drug.
While silent as to intended use of introducing a foreign substance, here a polypeptide both mature and precursor, from the outside to the inside of a eukaryotic cell, said CN101144080A is intended for treatment of Alzheimer’s disease in human patients – See Abstract and 3rd paragraph under “Description”. In addition, as described above, “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). M.P.E.P. § 2112(I).
With regard to claims 8-11, it is noted the last limitation of claim 10 recites “at least one amino acid residue of the foreign substance introduction construct is converted to an amide” is an inherent feature of every single peptide and protein because amide groups containing a nitrogen atom bonded directly to a carbonyl group is the principal building block of protein. Every single peptide and protein comprise amides once two or more amino acids are linked together. As such, inherently the teachings of CN101144080A meets this limitation.
Applicant’s Response and Examiner’s Rebuttal:
Applicants contend CN101144080A and Li et al. do not anticipate claim 6 because it does not teach the peptide attached to a nucleic acid or a drug.
This is not convincing because as noted above, the specification is void of any kind specific definition of what constitutes a “drug”, the fusion with VIP and its potential therapeutic effects for Alzheimer’s treatment (See Section 1.1) meets the limitations of “a drug”. It is further noted, however, that in instant paragraph 0068 (PG-Pub) it is acknowledged that “peptide drugs” do exist. The VIP peptide as taught is deemed a peptide drug.
Claim(s) 8-12 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Reed et al. (US 20030175819 – cited previous PTO-892 01/29/2026) as evidenced by Tsien (Ann. Rev. Biochem, 1998 – cited herein).
Reed et al. teach:
Regarding claims 8-11, wild-type humanin (SEQ ID NO: 2 - MAPRGFSCLLLLTSEIDLPVKRRA) fused on its N-terminus to a Green Fluorescent Protein (GFP)– See paragraph 0044, Figure 3B, Figures 4A and 4B, Example 5.
Regarding claim 12, Tsien evidences GFP is a 238 amino acid protein (See p. 512-513).
Regarding the intended use of the instant claims, e.g. foreign substance introduction construct, while silent to this aspect, it is noted: “The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not impart novelty to the claimed product – In re Best 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). M.P.E.P. § 2112(I).
With regard to claim 10 and the last limitation of said claim which recites “at least one amino acid residue of the foreign substance introduction construct is converted to an amide”, this is an inherent feature of every single peptide and protein because amide groups containing a nitrogen atom bonded directly to a carbonyl group is the principal building block of protein. Every single peptide and protein comprise amides once two or more amino acids are linked together. As such, inherently the teachings of Reed et al. meet this limitation.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 30 June 2026
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