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 .
Applicant’s response filed on 4/21/2026 is acknowledged and fully considered.
Status of Application, Amendments, And/Or Claims
The amendments of claims 1 and 4 have been made of record.
Claims 1-7 and 9-20 are pending.
Claims 2-5, 7 and 10-20 remain withdrawn for the reasons of record at pg.2 of the office action of 1/21/2026.
Claims 1,6 and 9 are under examination.
Response to Arguments
Claim Rejections - 35 USC § 103-maintained
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, 6 and 9 remain rejected under 35 U.S.C. 103 as being unpatentable over KR 10-1967630 B1 (IDS, 2019-04-11, also published as KR20180100944) over KR-10-1306643 B1(IDS, Helix Biomedix Inc) and as discussed below.
The instantly claimed invention is broadly drawn to a composition comprising a peptide having the amino acid sequence of SEQ ID NO: 2, wherein the peptide a C-terminal amino group (claims 1,9) and a pharmaceutical composition comprising the same.
KR 10-1967630 B1 teaches a composition comprising a peptide selected from amino acid sequences of SEQ ID Nos: 1-21, wherein the peptide of SEQ ID NO: 16 is 100% identical to the instantly claimed peptide of SEQ ID NO: 2 (GLYYF). The reference teaches to use the peptide in a composition for treating a skin disease (see an English translation of the abstract). Regarding claim 9, the claimed pharmaceutical composition comprises the same limitation as a composition taught by KR 10-1967630 B1, and therefore, meets the limitations. The reference does not teach that the C-terminal of the peptide is amidated.
KR-10-1306643 B1 teaches that the amidation of the C-terminal of a peptide results in increased activity and stability, wherein the peptide is a hexapeptide. (see paragraphs [0004], [0085-0086], and [0154], and claims 1, 10 and 15).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to amidate the C-terminal of peptide as taught by KR-10-1306643 B1 for the peptide having amino acid sequence of SEQ ID NO: 2 as taught by KR 10-1967630 B1. Additionally, one would have been motivated to do so because KR-10-1306643 B1 teaches that the amidation of the C-terminal of a peptide results in more stable and increased the activity of the peptide. Further, one would have a reasonable expectation of success for the peptide GLYYF (SEQ ID NO: 16) because KR-10-1306643 B1 teaches C-terminal amidation of a peptide and it is routine in the art. Therefore, the instant invention would have been obvious over the combined teachings of the prior art.
Applicants argue that it is difficult for one skill in the art to be motivated to apply amidation to the peptide of amino acid sequence of SEQ ID NO: 2. They argue that KR-10-1306643 describes amidation to a hexapeptide but the instant peptide is a pentapeptide. They argue that the instantly claimed peptide is aimed to increase stability and solubility as presented in Example 1, Table 3, phosphorylation of AMPK, and ability to inhibit hepatocyte accumulation (Fig. 5) with no induction in cytotoxicity. They argue that the statement “it is routine” to apply amidation at the C-terminus does not provide a reasonable expectation of success. They argue that amidation to the peptide of SEQ ID NO: 1 produced no improvement to AMPK phosphorylation. They argue that amidation to the peptide of SEQ ID NO: 2 provides better phosphorylation (presented in Fig. 4) and the peptide of SEQ ID NO: 2 with amidation has improved solubility (Table 3). They argue that the peptide of SEQ ID NO: 2 when amidated results in increased expression of adiponectin (Fig. 5-7).
Applicants’ arguments have been fully considered but they are not persuasive because it is routine to make modification of peptides results in more stable peptide as they are less accessible to exopeptidases (see Nuijens et al. Tetrahedron Letters 53:3777-3779, 2012). Nuijens et a. is applied to support the state of the art and not as a prior art. Regarding applicants’ arguments that the amidated peptide of SEQ ID NO: 2 results in improved characteristic that enhances phosphorylation of AMPK, increased expression of adiponectin, better stability and solubility, these characteristics are amidated peptides’ inherent feature. "[T]he 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 necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
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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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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