DETAILED ACTION
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 .
Election/Restrictions
Applicant’s election without traverse of Group 3 (claims 11,12,14,15,19, 22 and 23) and linker of SEQ ID NO: 30, and sequence in the reply filed on 12/12/2025 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1,2,4-9, 11,12 and 14-23 are pending.
Claims 1,2,4-9,16-18, and 20-21 are withdrawn for being drawn to non-elected inventions (i.e., Groups 1-2 and 4). Claim 14 is withdrawn for reciting a non-elected species.
Claims 11, 12, 15, 19, 22 and 23 are under examination to the extent they read on the elected species.
It is noted that ELC of 12/12/2025 includes 12 pages that includes Election, amended claims and Remarks.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) filed on 1/18/2023, 3/19/2024,11/13/2024 and 2/24/2025 have been considered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The disclosure is objected to because of the following informalities: ( i) it is noted to applicants that the specification at pg.10, paragraph [0075], line 1 discloses that “the aspartic acid at position 21of insulin A-chain is substituted by glycine” but the position 21 of natural amino acid is asparagine (see SEQ ID NO: 1); (ii) pg. 8, paragraph [0060], line 3, the term “SS302-Results for 014M” should be “SS302-14M”; and (iii) pg. 11, paragraph [0076], line 2 the term “a 14-carbon free fatty acid” should be “a 14-carbon fatty acid” to be proper and consistent as recited in paragraph [0077].
Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 11,12,19 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Lancaster et al. (US Pub. No. 20200231646, also published as US Pat. No. 10,870,68) in view of JP 2016-512255A (IDS, 3/19/2024).
The instantly claimed invention is broadly drawn to an insulin-Fc fusion protein with a structure Ins-L-Fc, wherein Ins is an insulin moiety providing insulin activity and comprises A and B-chains of insulin linked by a disulfide bond, L is a linker between Ins and Fc, wherein L is X2APPPX1LP (SEQ ID NO: 126), wherein X2 is P or K, and X1 is any amino acid (claim 11), wherein the insulin is selected from human insulin, bovine insulin or porcine insulin (claim 12). A pharmaceutic composition of claim 11, wherein the Fc region is an Fc derived from IgG2.
Lancaster et al. teach a fusion protein comprising an insulin linked with an Fc (insulin-Fc), wherein the insulin is linked via a linker (L), wherein in the linker is a peptide (see abstract, paragraph [0007]. They teach that the insulin-Fc can be a dimer. Regarding claim 19, they teach a pharmaceutical composition the insulin-Fc (abstract, paragraph [0017-0018], [0153-0160]). They teach that the peptide linker comprises amino acid sequence of SEQ ID NO: 14 (GGGGGQGGGGQGGGGQGGGGG). Lancaster et al do not teach that the linker comprises an amino acid sequence of SEQ ID NO: 126 (X2APPPX1LP), wherein X2 is P or K and X1 can be any amino acid.
JP 2016-512255A teaches a conjugate of insulin agonist/incretin comprising a glucagon-related peptide and an insulin peptide, wherein the glucagon-related peptide is linked to the insulin peptide through a linker. Regarding claim 11, the linker of SEQ ID NO: 126, JP 2016-512255A teaches a linker of SEQ ID NO: 52 which comprises amino acid sequence KAPPPS. They teach a linker of SEQ ID NO: 52 having amino acid sequence of SSSSKAPPPSLPSPSRLPGPSDTPILPQR.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use a linker that comprises amino acids KAPPPSLP as taught by JP 2016-512255A to make an insulin and an Fc fusion for a longer half-life as taught Lancaster et al. Additionally, one would have been motivated to do so because JP 2016-512255A teaches that a linker comprising KAPPPSLP to link an insulin with a glucagon-like peptide. Further, one would have a reasonable expectation of success in using a peptide linker that comprises amino acids KAPPPSLP to link two peptides as taught by JP2016-512255A and it is routine in the art to make a conjugate with a linker. Therefore, the instantly claimed invention would have been obvious to one ordinary skill in the art over the combined teachings of the prior art.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Lancaster et al. (US Pub. No. 20200231646, also published as US Pat. No. 10,870,68) in view of JP 2016-512255A (IDS, 3/19/2024) as applied to claims 11, 12, 19 and 22 above, and further in view of Su et al. (US Pub. No. 20220323590).
The instantly claimed invention is broadly drawn to an insulin-Fc fusion protein with a structure Ins-L-Fc, wherein Ins is an insulin moiety providing insulin activity and comprises A and B-chains of insulin linked by a disulfide bond, L is a linker between Ins and Fc, wherein L comprises amino acid sequence of SEQ ID NO: 30.
The teachings of Lancaster et al. and JP 2016-512255A are set forth supra. Neither Lancaster et al. nor JP 2016-512255A teaches that the linker comprises amino acid sequence of SEQ ID NO:3 which is 100% identical to the instantly claimed linker sequence. They teach to conjugate an Fc with coagulation factor using either a flexible marker or a rigid peptide, wherein the rigid peptide comprises amino acid sequence of SEQ ID NO:3 (VAPPPALPAPVRLPGPA) (see paragraph [0009]).
Therefore, it would have been prima facie obvious to one ordinary skill in the art at the time the invention was made to use a linker that comprises amino acids of SEQ ID NO: 3 as taught by Su et al which is 100% identical to the instantly claimed linker of SEQ ID NO: 3 to make an insulin and an Fc fusion for a longer half-life as taught Lancaster et al. in view of JP 2016-512255A. Additionally, one would have been motivated to do so because Su et al teach using a rigid peptide linker to make a conjugate with an Fc. Further, one would have a reasonable expectation of success in using a peptide linker that comprises amino acids of SEQ ID NO: 30 to link two peptides as taught by Su et al. and it is routine in the art to conjugate two peptides with a linker. Therefore, the instantly claimed invention would have been obvious to one ordinary skill in the art over the combined teachings of the prior art.
Conclusion
Claims 11, 12, 15, 19 and 22 are rejected.
Claim 23 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. The amino acid sequence of SEQ ID NO: 87 (insulin B-chain) and the amino acid sequence of SEQ ID NO: 88 (insulin A-chain, L and Fc) are free of prior art.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674