DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group II, claims 6-9 in the reply filed on 06 January 2026 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-9 are pending; Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim.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 6-9 are subject to examination on the merits.
Priority
The instant application is a 371 of PCT/JP2021/037981 filed 14 October 2021 which claims benefit of foreign priority document JP 2020-177944 filed 23 October 2020 is acknowledged. Said document has been received.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04 December 2025, 18 September 2025, 28 December 2023 and 21 April 2023 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
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) 6-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma et al. (Acta Pharmcologica Sinica, 2018 – cited herein).
Ma et al. teach:
A construct comprising SEQ ID NO: 1 (MAPRGFSCLLLLTSEIDLPVKRRA) linked to a dye on the 21st lysine of the peptide – See p. 1016, 2nd col., 1st full paragraph:
“HN binds to Bax and cBid in solution and in the membrane
Previous fluorescence polarization (FP) assays showed that
HN binds Bax or Bid in solution [14, 15]. To verify the interactions
by using the FRET technique, we labelled HN with Cy3
dye. The amino acid sequence of HN is MAPRGFSCLLLLTSEIDLPVKRRA.”
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).
Claim(s) 6-8 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.
Claim(s) 6-9 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Reed et al. (US 20030175819 – cited herein).
Reed et al. teach:
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 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).
Claim(s) 6-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN101144080A, published 2008; cited herein – 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 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.
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).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 22 January 2026