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 I (claims 1-4 and 18-20) and amino acid sequence of SEQ ID NO: 11 in the reply filed on 8/6/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-20 are pending.
Claims 5-17 are withdrawn for being drawn to non-elected inventions (i.e., Groups II-IV).
Claims 1-4 and 18-20 are under examination to the extent they read on the elected sequences.
Applicants are suggested to cancel claims drawn to non-elected inventions.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 5/15/2024 has been considered.
Claim Objections
Claims 1, 4 and 19 are objected to because of the following informalities: claims 1,4 and 19 are objected for reciting a non-elected sequence. Applicants are suggested to delete non-elected sequences from the claims.
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) 1-4 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Larsen et al. (US Pat. No. 6,528,486) and O’Donoghue et al. (BR PI0208851) and Tran et al. (IDS, J. Am. Chem.Soc. 124: 5222-5230, 2002).
The instantly claimed invention is broadly drawn to a peptide comprising amino acid sequence of SEQ ID NO: 11, a salt or solvate thereof (claim 1), wherein the C-terminus is amidated (claim 2), a pharmaceutical composition comprising the peptide of claim 1 and a pharmaceutically carrier for treating a disease (claim 3), wherein the disease is diabetes or obesity (claim 4). A kit comprising any thioamide-modified peptide and instructional material for treating a disease (claim 18), wherein the peptide comprises amino acid sequence of SEQ ID NO: 11 (claim 19), and wherein the disease is selected from diabetes, obesity, hypertension and congestive heart failure (claim 20).
Larsen et al teach a peptide having 100% identity from amino acid 3-38 of SEQ ID NO:11 (see sequence alignment). The instantly claimed amino acid sequence at position 1 and 2 are X1X2, wherein X1 is H or P, and Larsen et al teach histidine at position X1 (see amino acid sequence of SEQ ID NO: 101). They teach that X2 is susceptible for Dipeptidyl peptidase IV cleavage (col.1, lines 55+) and therefore, they suggest modifying X2 position for a resistant analog. The prior art has used Aib to substitute at position X2 (including in Semaglutide). They do not teach to use a thioamide bond at X2.
O’Donoghue et al. teach incorporating non-natural amino acid to make polypeptide peptidomimetic composition to make a stable polypeptide and they suggest using thioamide or ester for peptide bonding (pg. 197, [00474]). They teach a kit and instruction material for using the same (pg. 207).
Tran et al. teach using thioamide amino acids in a peptide or protein for drug design because substitution of an amino acid with thioamide amino acid makes the peptide or protein resistance to enzymatic degradation and are predicted to be more rigid (abstract). They teach substituting alanine with thioalanine or polyalanine with polythioalanine (Methods).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to substitute alanine at position 8 of exedin-4 (a GLP-1 agonist) with a thioamide alanine as taught by Tran et al to make a protease resistant peptide for increasing the half-life without affecting the affinity of exendin to GLP-1R as suggested by O’Donoghue et al for treating diabetes using exendin-4 analog as taught by Larsen et al. One of ordinary skill of the art would have been motivated to do so because Tran et al teach making many substitutions at positions 8 (Alanine) to make the peptide more stable and peptidase DPP IV resistant by including thioamide alanine and to make a peptide structurally stable for therapeutic purposes. Additionally, One would have a reasonable expectation of success in substituting amino acid at position 8 of polypeptide of SEQ ID NO: 11 with thioamide alanine because Tran teach substituting alanine with a thioamide alanine. Therefore, the instantly claimed invention would have been obvious over the combined teachings of the prior art.
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Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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