DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Amendment after Non-final office action filed on 7/20/2026 is acknowledged.
3. Claim filed on 7/20/2026 is acknowledged.
4. Claim 2-7 and 18-33 have been cancelled.
5. New claims 34 and 35 have been added.
6. Claims 1, 8-17, 34 and 35 are pending in this application.
7. Claims 8-17 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 9/8/2025.
8. Applicant elected with traverse of Group 1 (claims 1-3) and elected a composition comprising SEQ ID NO: 13 as species of composition in the reply filed on 9/8/2025.
Restriction requirement was deemed proper and made FINAL in the previous office actions. Group 1 is drawn to a composition comprising a surfactant protein A (SP-A) peptide, wherein the SP-A peptide is selected from the group consisting of SEQ ID NOs: 3 and 7-15; a composition comprising a surfactant protein A (SP-A) peptide, wherein the SP-A peptide is SEQ ID NO: 13; and a composition comprising a surfactant protein A (SP-A) peptide, wherein the SP-A peptide is SEQ ID NO: 15. A search was conducted on the elected species; and this appears to be free of prior art. A search was extended to the genus in claims 1, 34 and 35; and the genus of claims 34 and 35 appear to be free of prior art. However, prior art was found for the genus in claim 1. Claims 1, 34 and 35 are examined on the merits in this office action.
Withdrawn Objections and Rejections
9. Objection to claims 1-3 is hereby withdrawn in view of Applicant's amendment to the claim.
10. Rejection to claim 1 under 35 U.S.C. 103 as being unpatentable over Ledford et al (WO 2017/180546 A1, filed with IDS) in view of Peers et al (US 5837218 A, cited and enclosed in the previous office action) is hereby withdrawn in view of Applicant's amendment to the claim.
11. Rejection to claim 1 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of US patent 11110152 B2 in view of Peers et al (US 5837218 A, cited and enclosed in the previous office action) is hereby withdrawn in view of Applicant's amendment to the claim.
Maintained/Revised Objections
12. (Revised due to Applicant’s amendment to the specification) The specification remains objected to for the following minor informality: Applicant is suggested to amend the amino acid sequence of instant SEQ ID NO: 6 recited on page 25, Table 1 of instant specification as “HKEQCVEMYTD-acid”.
Please note: The specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification (see MPEP § 608.01).
Response to Applicant's Arguments
13. Applicant fails to address all the minor issues in the specification. Therefore, the objection is deemed proper and is hereby maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 103
14. 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 of this title, 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.
15. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
16. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Awasthi (US 2014/0256613 A1, filed with IDS) in view of Peers et al (US 5837218 A, cited and enclosed in the previous office actions).
The instant claim 1 is drawn to a composition comprising a surfactant protein A (SP-A) peptide, wherein the SP-A peptide is selected from the group consisting of SEQ ID NOs: 3 and 7-15.
Awasthi teaches peptide of SEQ ID NO: 3 consisting of the amino acid sequence GDFRYSDGTPVNYTNWYRGE (identical to the amino acid sequence of instant SEQ ID NO: 11) that binds to Toll-like receptor-4 (TLR4)-MD2 protein, inhibits expression of TLR4 and reduces the release of TNF-α in response to the most potent TLR4-ligand; and a method of decreasing the occurrence and/or severity of inflammation associated with a disease condition, wherein TLR4 signaling is involved in the inflammation associated with the disease condition, wherein the method comprises administering an effective amount of a composition comprising such peptide, for example, Figure 20; page 21, paragraph [0158]; pages 21-26, Example 2; page 45, SEQ ID NO: 3; and claim 1.
The difference between the reference and instant claim 1 is that the reference does not explicilty teach the peptide of SEQ ID NO: 3 has N-terminal acetylation and C-terminal amidation.
However, Peers et al teach that N-terminal modification such as protecting the N-terminal end of peptide with an acetyl group and the C-terminal modification such as amidation are common practice in the art of preparation of peptides having greater stability, particularly for in vivo use, for example, column 3, lines 8-40.
Therefore, it would have been obvious to one of ordinary skilled in the art to combine the teachings of Awasthi and Peers et al to develop a composition comprising the peptide of SEQ ID NO: 3 in Awasthi with the N-terminal acetylation and C-terminal amidation (identical to the SP-A peptide of instant SEQ ID NO: 11).
One of ordinary skilled in the art would have been motivated to combine the teachings of Awasthi and Peers et al to develop a composition comprising the peptide of SEQ ID NO: 3 in Awasthi with the N-terminal acetylation and C-terminal amidation (identical to the SP-A peptide of instant SEQ ID NO: 11), because Peers et al teach that N-terminal modification such as protecting the N-terminal end of peptide with an acetyl group and the C-terminal modification such as amidation are common practice in the art of preparation of peptides having greater stability, particularly for in vivo use.
A person of ordinary skilled in the art would have reasonable expectation of success in combining the teachings of Awasthi and Peers et al to develop a composition comprising the peptide of SEQ ID NO: 3 in Awasthi with the N-terminal acetylation and C-terminal amidation (identical to the SP-A peptide of instant SEQ ID NO: 11).
Allowable Subject Matters
17. The compositions recited in instant claims 34 and 35 are free of prior art. The closest prior arts are Awasthi (US 2014/0256613 A1, filed with IDS) and Peers et al (US 5837218 A, cited and enclosed in the previous office actions); and the teachings of such prior art references have been set forth in Section 16 above. However, there is no teaching, motivation, or other type of suggestion to modify the SP-A peptide in Awasthi and arrive at the compositions recited in instant claims 34 and 35. Therefore, the compositions recited in instant claims 34 and 35 are both novel and unobvious over the prior arts of record. And the claimed compositions are markedly different from what exist in nature.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Claim 1 is rejected. Claims 8-17 are withdrawn. Claims 34 and 35 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI N KOMATSU whose telephone number is (571)270-3534. The examiner can normally be reached Mon-Fri 8am-4pm EST.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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