A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/7/2026 has been entered.
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 Final office action filed on 4/7/2026 is acknowledged.
3. Please do NOT enter the amendment to the specification filed on 4/7/2026.
4. Claim filed on 4/7/2026 is acknowledged.
5. Claim 4-7 and 18-33 have been cancelled.
6. Claims 1-3 and 8-17 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 Claims 8-17 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.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 a group consisting of SEQ ID NOs: 2, 3 and 7-15. 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 claim 1; and prior art was found. Claims 1-3 are examined on the merits in this office action.
Non-Compliant Amendment
9. The claim filed on 4/7/2026 is a non-compliant amendment. In the claim filed on 4/7/2026, claim 3 has the status identifier of “(Currently amendment)”. However, claim 3 is also cancelled. Applicant is required to correct this error (see MPEP § 714).
Terminal Disclaimer
10. The terminal disclaimer filed on 4/7/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of co-pending Application No. 17/409642 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Withdrawn Rejections
11. Rejection to claim 1 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is hereby withdrawn in view of Applicant's amendment to the claim.
12. Rejection to claims 1-3 under 35 U.S.C. 101 is hereby withdrawn in view of Applicant's amendment to the claim.
13. Rejection to claims 1-3 under 35 U.S.C. 102(a)(1) as being anticipated by Ledford et al (WO 2017/180546 A1, filed with IDS) is hereby withdrawn in view of Applicant's amendment to the claim.
14. Rejection to claims 1-3 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 2, 16 and 17 of co-pending Application No. 17/409642 and in view of Peers et al (US 5837218 A) is hereby withdrawn in view of Applicant's filing of terminal disclaimer on 4/7/2026.
Maintained/Revised Objections
15. (Revised) The specification remains objected to for the following minor informality: The peptides of SEQ ID NOs: 4 and 6 recited throughout the specification are inconsistent with the peptides of SEQ ID NOs: 4 and 6 in the sequence listing filed on 1/13/2026. As an example, in the sequence listing filed on 1/13/2026, the peptide of instant SEQ ID NO: 6 is 10 amino acids in length with His being the 1st amino acid.
Furthermore, Applicant is suggested to amend the amino acid sequence of instant SEQ ID NO: 6 as “HKEQCVEMYTD-acid (SEQ ID NO: 6)” throughout the specification.
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).
16. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: Applicant is suggested to amend claim 1 as “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: 2, 3 and 7-15”.
17. (Revised due to Applicant’s amendment to the claim) Claims 2 and 3 remain 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.
Response to Applicant's Arguments
18. The instant specification does not contain any paragraph number. Therefore, the amendment to the specification filed on 4/7/2026 is not entered, and the specification remains objected. Furthermore, Applicant’s amendment to the claim introduces additional minor issues into these claims. Taken all these together, these objections are deemed proper and are hereby maintained.
Maintained/Revised Rejections
Obviousness Double Patenting
19. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
20. (Revised due to Applicant’s amendment to the claim) Claim 1 remains rejected 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).
21. Instant claim 1 is drawn to a composition comprising a surfactant protein A (SP-A) peptide, wherein the SP-A peptide is selected from a group consisting of SEQ ID NOs: 2, 3 and 7-15.
22. Claims 1-4 of US patent 11110152 B2 are drawn to a method, comprising: delivering a composition comprising a peptide consisting of KEQCVEMYTD (SEQ ID
NO: 4) to a lung cell in a subject, wherein said delivering results in one or more of enhancing SP-A activity in the cell, and treating asthma in the subject.
The peptide of SEQ ID NO: 4 recited in claims 1-4 of US patent 11110152 B2 is identical to the amin acid sequence of instant SEQ ID NO: 2.
23. The difference between the peptide of SEQ ID NO: 4 recited in claims 1-4 of US patent 11110152 B2 and the composition recited in instant claim 1 is the peptide of SEQ ID NO: 4 recited in claims 1-4 of US patent 11110152 B2 does not have the 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, in view of the teachings of Peers et al, it would have been obvious to one of ordinary skilled in the art to modify the peptide of SEQ ID NO: 4 recited in claims 1-4 of US patent 11110152 B2 and develop a composition comprising the peptide of instant SEQ ID NO: 2 recited in instant claim 1.
Response to Applicant's Arguments
24. Applicant argues that “As amended, claims 1-3 no longer recite SEQ ID NO: 5 and, therefore, do not encompass or read on SEQ ID NO: 4 of the '152 patent. Accordingly, the presently pending claims are patentably distinct from claims 1-4 of the '152 patent.”
25. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about the ODP rejection over claims 1-4 of US patent 11110152 B2, the Examiner understands that instant claim 1 does not recite SEQ ID NO: 5. However, in the instant case, as stated in Section 23 above, in view of the teachings of Peers et al, it would have been obvious to one of ordinary skilled in the art to modify the peptide of SEQ ID NO: 4 recited in claims 1-4 of US patent 11110152 B2 and develop a composition comprising the peptide of instant SEQ ID NO: 2 recited in instant claim 1.
Therefore, until a proper terminal disclaimer is filed and approved by the Office, the double patenting rejection is hereby maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 103
26. 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.
27. 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.
28. Claim 1 is rejected 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).
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 a group consisting of SEQ ID NOs: 2, 3 and 7-15.
Ledford et al teach a composition comprising a peptide consisting of the amino acid sequence KEQCVEMYTD (SEQ ID NO: 4, identical to the amino acid sequence of instant SEQ ID NO: 2) that can be used in the treatment and prevention of lung disease, for example, Abstract; page 4, lines 31-40; and page 10, lines 30-35.
The difference between the reference and instant claim 1 is that the reference does not explicilty teach the peptide of SEQ ID NO: 4 has N-terminal acetylation and C-terminal amidation.
However, Ledford et al teach such peptide can be modified with modifications including N-terminal modification and C-terminal modification to protect the peptide from proteolytic degradation, for example, page 11, lines 14-19.
Furthermore, 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 Ledford et al and Peers et al to develop a composition comprising the peptide of SEQ ID NO: 4 in Ledford et al with the N-terminal acetylation and C-terminal amidation (identical to the SP-A peptide of instant SEQ ID NO: 2).
One of ordinary skilled in the art would have been motivated to combine the teachings of Ledford et al and Peers et al to develop a composition comprising the peptide of SEQ ID NO: 4 in Ledford et al with the N-terminal acetylation and C-terminal amidation (identical to the SP-A peptide of instant SEQ ID NO: 2), because Ledford et al teach such peptide can be modified with modifications including N-terminal modification and C-terminal modification to protect the peptide from proteolytic degradation. And 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 Ledford et al and Peers et al to develop a composition comprising the peptide of SEQ ID NO: 4 in Ledford et al with the N-terminal acetylation and C-terminal amidation (identical to the SP-A peptide of instant SEQ ID NO: 2).
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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