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 of Group I, claims 1, 3-4, and 6-11 in the reply filed on 5/11/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s species election is as shown follows.
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Claim Status
Claims 1, 3-4, and 6-11 are pending.
Claims 2, 5, and 12-28 are cancelled.
Claim 3 and 10 are withdrawn as being directed to a non-elected species, the election having been made on 5/11/2026.
Claims 1, 4, 6-9, and 11 have been examined.
Priority
This application is a 371 of PCT/US2022/025764 04/21/2022
PCT/US2022/025764 has PRO 63/178,083 04/22/2021
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/19/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 6-9 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a polypeptide comprising the Cα peptide able to treat a patient with type-2 diabetics (e.g., hyperglycemia), does not reasonably provide enablement for a peptide consisting of the Cα peptide able to treat hyperglycemia in a patient with type-2 diabetics. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. Wands factors to assess Enablement are shown as follows.
The breadth of the claims is much broader than support of the enabled examples.
The nature of the invention is the use of an insulin Cα peptide derived from an isoform of insulin to inhibit amyloidosis in a subject with diabetes or Alzheimer’s disease.
The state of the prior art of Kim et al. (US 2016/0184402 A1) recognizes administration of a C-peptide partially deleted mutant of monomeric proinsulin comprising the Cα peptides of SEQ ID NOs: 7-8 [0013, claim 20], NOT a peptide consisting of the Cα peptides of SEQ ID NOs: 7-8, for improving immunity of a diabetic patient [0014].
(D) The level of one of ordinary skill is low because there is no evidence of a peptide consisting of an insulin Cα peptide (e.g., SEQ ID NOs: 7-8) able to treat all symptoms in a patient with type-2 diabetes, such as hyperglycemia of type-2 diabetics.
(E) The level of predictability in the art is low because there is no evidence to use a peptide consisting of an insulin Cα peptide (e.g., SEQ ID NOs: 7-8) to treat all symptoms in a patient with type-2 diabetes, such as hyperglycemia of type-2 diabetics.
(F) The amount of direction provided by the inventor is limited because Example 9 only supports inhibition of amyloidosis in vivo by a Cα peptide, not sufficient to support treatment of all symptoms in a patient with type-2 diabetes, such as hyperglycemia of type-2 diabetics.
(G) The existence of working examples. Example 9 only supports inhibition of amyloidosis in vivo by Cα peptide, not sufficient to support treatment of all symptoms in a patient with type-2 diabetics, such as hyperglycemia of type-2 diabetes.
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure is unknown because there is no evidence of a peptide consisting of an insulin Cα peptide (e.g., SEQ ID NOs: 7-8) able to treat all symptoms in a patient with type-2 diabetes, such as hyperglycemia.
Claims 4, 6-9, and 11 are further rejected as depending on claim 1.
The rejection may be overcome by explicitly claiming the Cα peptide sequences and treated diseases supported by the original specification without NEW MATTER.
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, 4, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 2016/0184402 A1).
Claim 1 is drawn to a method of treating a subject with diabetes, or Alzheimer’s disease or inhibiting amyloidosis in a subject, comprising administering to the subject a composition comprising an insulin Cα peptide to a subject in need thereof.
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Kim et al. teach the use of proinsulin for immune system modulation (Title). Kim et al. teach a preferred peptide as SEQ ID NO: 5 [0013, claim 20] comprising the elected insulin Cα peptide of underlined SEQ ID NO: 7 as shown follows. Kim et al. teach administration of a composition comprising SEQ ID NO: 5 (a C-peptide partially deleted mutant of monomeric proinsulin) for improving immunity of a diabetic patient [0014], at once envisage treating patients with either type I or type II diabetes [0004], reading on claims 1, 4, and 8.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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.
Claims 1, 4, 6-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. as applied to claims 1, 4, 8 and further in view of Menting et al. (US 2019/0241640 A1).
The broadest interpretation of claim 6 is drawn to the Cα-containing peptide further comprising one or more modifications.
The examiner Kim et al. teach administration of a composition comprising SEQ ID NO: 5 (a C-peptide partially deleted mutant of monomeric proinsulin) for improving immunity of a diabetic patient [0014], with type I or type II diabetes [0004].
Kim et al. did not teach modification of the therapeutic peptide.
Menting et al. teach insulin analogs (Abstract). Menting et al. teach the use of an insulin analog to treat hyperglycemia in patients with type 1 diabetes or type 21 diabetes [0038].
With respect to claim 6-7, Menting et al. teach C-terminal amidation for a therapeutic peptide [0105] to increase the stability and/or bioactivity of the peptide [0114, last 3 line].
With respect to claim 9, Menting et al. teach treatment of diabetes often involves administration of a combination of rapid acting, pre - prandial insulin as well as a longer - acting insulin to maintain basal levels of the hormone [0005]. Menting et al. further teach more than one therapeutic agent is used in combination [0125, 0326]. Thus, one of ordinary skill in the art would have been taught and/or suggested to beneficially combine Kim’s therapeutic peptide and Menting’s insulin analog for the same purpose to treat a patient with type-1 or type-2 diabetes.
With respect to claim 11, Menting et al. teach a pharmaceutical composition comprising an insulin analog can be administered by any route known in the art including a preferred parenteral route or oral administration [0321].
Examiner Note:
The examiner did not find a prior art teaching the peptide sequences consisting of SEQ ID Nos: SEQ ID NOs: 7-8. The closest prior art reference, Barrack et al. (US 2012/0220542 A1, cited in IDS), teaches various PEGylated C-peptides, but the peptides do not read on the peptide sequences of SEQ ID NOs: 7-8. The other reference, Kim et al. (US 2016/0184402 A1), teaches a peptide comprising SEQ ID Nos: SEQ ID NOs: 7-8, but not a peptide sequence consisting of SEQ ID Nos: SEQ ID NOs: 7-8.
Conclusion
No claim is allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.L/Examiner, Art Unit 1658
7/17/2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
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