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 12/24/2025 is acknowledged.
3. Claim filed on 12/24/2025 is acknowledged.
4. Claim 4-7 and 18-33 have been cancelled.
5. Claims 1-3 and 8-17 are pending in this application.
6. Claims 8-17 remain withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.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.
7. 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 action. Group 1 is drawn to a composition comprising a surfactant protein A (SP-A) peptide comprising an amino acid that is at least 90% identical to the amino acid sequence selected from the group consisting of Ac-KEQCVEMYTD-NH2 (SEQ ID NO: 2), Ac-WGKEQCVEMYTD-NH2 (SEQ ID NO: 3), (Ac-KEQCVEMYTD-NH2)2 (SEQ ID NO: 4), Ac-KEQCVEMYTD-acid (SEQ ID NO: 5), H-KEQCVEMYTD-acid (SEQ ID NO: 6), Ac-KEQCVE-Nle-YTD-NH2 (SEQ ID NO: 7), Ac-KEQSVEMYTD-NH2 (SEQ ID NO: 8), Ac-KEQAVEMYTD-NH2 (SEQ ID NO: 9), Ac-SDGTPVNYTNWYRGEPAGRGKEQ-NH2 (SEQ ID NO: 10), Ac-GDFRYSDGTPVNYTNWYRGE-NH2 (SEQ ID NO: 11), Ac-WGKEQAVE-Nle-YTD-NH2 (SEQ ID NO : 12), Ac-WGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 13), Ac-RGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 14), and Ac-wGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 15). A search was conducted on the elected species; 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.
Claim Interpretations
8. With regards to the peptide recited in instant claims 1-3, as stated in the previous office action, for a peptide comprising the amino acid sequence of any one of the recited SEQ ID NOs that have N- and/or C-terminal modification, the claimed peptide in the composition is not required to have such modification. As an example, AKEQAVEMYTDA is a peptide comprising the amino acid sequence of instant SEQ ID NO: 9.
Furthermore, with regards to the amino acid sequence of instant SEQ ID NO: 6, in the instant case, in view of Applicant’s arguments and the disclosure of instant specification, for the purpose of compact prosecution, the Examiner is interpretating instant SEQ ID NO: 6 as “HKEQCVEMYTD-acid (SEQ ID NO: 6)” with H being the N-terminal amino acid histidine and being 11 amino acids in length.
Such interpretations apply to all rejections set forth below.
Maintained/Revised Objections
9. (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).
10. (Revised due to Applicant’s amendment to the claim) Claim 1 remains objected to for the following minor informality: “A composition comprising a peptide comprising the amino acid sequence that is at least 90% identical to the amino acid sequence selected from the group consisting of Ac-KEQCVEMYTD-NH2 (SEQ ID NO: 2), Ac-WGKEQCVEMYTD-NH2 (SEQ ID NO: 3), (Ac-KEQCVEMYTD-NH2)2 (SEQ ID NO: 4), Ac-KEQCVEMY TD-acid (SEQ ID NO: 5), HKEQCVEMYTD-acid (SEQ ID NO: 6), Ac-KEQCVE-Nle-YTD-NH2 (SEQ ID NO: 7)…Ac-RGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 14), and Ac-wGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 15)”.
11. (Revised due to Applicant’s amendment to the claim) Claim 2 remains objected to for the following minor informality: Applicant is suggested to amend claim 2 as “…wherein the peptide comprises the amino acid sequence that is at least 95% identical to the amino acid sequence…Ac-WGKEQCVEMYTD-NH2 (SEQ ID NO: 3), (Ac-KEQCVEMYTD-NH2)2 (SEQ ID NO: 4), Ac-KEQCVEMYTD-acid (SEQ ID NO: 5), HKEQCVEMYTD-acid (SEQ ID NO: 6)…Ac-RGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 14), and Ac-wGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 15)”.
12. (Revised due to Applicant’s amendment to the claim) Claim 3 remains objected to for the following minor informality: Applicant is suggested to amend claim 3 as “The composition of claim 1, wherein the peptide comprises the amino acid sequence selected from the group consisting of Ac-KEQCVEMYTD-NH2 (SEQ ID NO: 2), Ac-WGKEQCVEMYTD-NH2 (SEQ ID NO: 3), (Ac-KEQCVEMYTD-NH2)2 (SEQ ID NO: 4), Ac-KEQCVEMYTD-acid (SEQ ID NO: 5), HKEQCVEMYTD-acid (SEQ ID NO: 6)…Ac-RGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 14), and Ac-wGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 15)”.
Furthermore, the peptides of SEQ ID NOs: 4 and 6 recited in instant claims 1-3 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.
Response to Applicant's Arguments
13. As stated in Section 8 above, with regards to the amino acid sequence of instant SEQ ID NO: 6, for the purpose of compact prosecution, the Examiner is interpretating instant SEQ ID NO: 6 as “HKEQCVEMYTD-acid (SEQ ID NO: 6)” with H being the N-terminal amino acid histidine. Furthermore, the term “an amino acid sequence” broadly includes both fragment and full length of each of the recited SEQ ID NOs. Therefore, in the instant case, Applicant either fails to address all the minor issues in the specification and these claims or Applicant’s amendment introduces additional minor issues into the specification and these claims. Taken all these together, these objections are deemed proper and are hereby maintained.
New Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
14. The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
15. Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
16. Claim 1 recites “…a surfactant protein A (SP-A) peptide comprising an amino acid that is at least 90% identical to the amino acid sequence selected from the group consisting of…”. It is unclear to the Examiner what the recited “an amino acid that is at least 90% identical to the amino acid sequence selected from the group consisting of…” is. Therefore, the metes and bounds of instant claim 1 is vague and indefinite.
Furthermore, for the purpose of the examination, the Examiner is interpretating such the recited “…a surfactant protein A (SP-A) peptide comprising an amino acid that is at least 90% identical to the amino acid sequence selected from the group consisting of…” as “…a surfactant protein A (SP-A) peptide comprising the amino acid sequence that is at least 90% identical to the amino acid sequence selected from the group consisting of…”. Such interpretation applies to all the rejections set forth below.
Maintained/Revised Rejections
Claim Rejections - 35 U.S.C. § 101
17. 35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
18. (Revised due to Applicant’s amendment to the claim) Claims 1-3 remain rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-3 are directed to a composition comprising natural product. As evidenced by the GENBANK: AAA36520.1, “Pulmonary Surfactant-Associated Protein [Homo Sapiens]" document (Retrieved on December 20, 2024, 2 pages, Online Available at: <https://www.ncbi.nlm.nih.gov/protein/AAA36520.1>, filed with IDS), the natural occurring pulmonary surfactant-associated protein from human is a peptide comprising the amino acid sequence of instant SEQ ID NO: 2 or 5.
The claims 1-3 do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed composition in instant claims 1-3 does not recite features or steps demonstrating a marked difference from what exists in nature; and the claimed composition in instant claims 1-3 does not recite meaningful limitations that add something of significance to the judicial exception. Therefore, the claimed composition in instant claims 1-3 is not significantly different than a judicial exception (natural product).
Response to Applicant's Arguments
19. Applicant argues that “As confirmed in the Replacement Sequence Listing, each of the presently claimed peptides includes specific N- and/or C-terminal modifications (and, where applicable, amino acid substitutions), rendering them structurally and functionally distinct from any naturally occurring peptide.”
20. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner would like to point out that in view of the claim interpretations as set forth in Section 8 above, the natural occurring pulmonary surfactant-associated protein from human is a peptide comprising the amino acid sequence of instant SEQ ID NO: 2 or 5.
Taken all these together, the rejection is deemed proper and is hereby maintained.
Claim Rejections - 35 U.S.C. § 102(a)(1)
21. 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.
22. (Revised due to Applicant’s amendment to the claim) Claims 1-3 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ledford et al (WO 2017/180546 A1, filed with IDS).
The instant claims 1-3 are drawn to a composition comprising a surfactant protein A (SP-A) peptide comprising an amino acid that is at least 90% identical to the amino acid sequence selected from the group consisting of Ac-KEQCVEMYTD-NH2 (SEQ ID NO: 2), Ac-WGKEQCVEMYTD-NH2 (SEQ ID NO: 3), (Ac-KEQCVEMYTD-NH2)2 (SEQ ID NO: 4), Ac-KEQCVEMYTD-acid (SEQ ID NO: 5), H-KEQCVEMYTD-acid (SEQ ID NO: 6), Ac-KEQCVE-Nle-YTD-NH2 (SEQ ID NO: 7), Ac-KEQSVEMYTD-NH2 (SEQ ID NO: 8), Ac-KEQAVEMYTD-NH2 (SEQ ID NO: 9), Ac-SDGTPVNYTNWYRG EPAGRGKEQ-NH2 (SEQ ID NO: 10), Ac-GDFRYSDGTPVNYTNWYRGE-NH2 (SEQ ID NO: 11), Ac-WGKEQAVE-Nle-YTD-NH2 (SEQ ID NO : 12), Ac-WGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 13), Ac-RGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 14), and Ac-wGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 15).
Ledford et al teach a composition comprising a peptide consisting of the amino acid sequence PAGRGKEQCVEMYTDGQWND(SEQ ID NO: 8, comprising the amino acid sequence of instant SEQ ID NO: 2 or 5, underlined), for example, page 4, lines 31-40. It meets the limitations of instant claims 1-3.
Furthermore, the MPEP states the following: A genus does not always anticipate a claim to a species within the genus. However, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. See Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (See MPEP § 2131.02).
Since the reference teaches all the limitations of instant claims 1-3; the reference anticipates instant claims 1-3.
Response to Applicant's Arguments
23. Applicant argues that “the Ledford prior art does not teach all the elements in each of these claims. For example, the Ledford prior art does not disclose the peptides as currently claimed. As reflected in the Replacement Sequence Listing, each claimed peptide includes defined N- and/or C-terminal modifications and/or amino acid substitutions that are absent from the peptides taught in the Ledford prior art.”
24. Applicant's arguments have been fully considered but have not been found persuasive.
In response to Applicant’s arguments about instant rejection, the Examiner would like to point out that in view of the claim interpretations as set forth in Section 8 above, Ledford et al teach a composition comprising a peptide comprising the amino acid sequence of instant SEQ ID NO: 2 or 5.
Taken all these together, the rejection is deemed proper and is hereby maintained.
Obviousness Double Patenting
25. 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.
26. (Revised due to Applicant’s amendment to the claim) Claims 1-3 remain 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).
27. Instant claims 1-3 are drawn to a composition comprising a surfactant protein A (SP-A) peptide comprising an amino acid that is at least 90% identical to the amino acid sequence selected from the group consisting of Ac-KEQCVEMYTD-NH2 (SEQ ID NO: 2), Ac-WGKEQCVEMYTD-NH2 (SEQ ID NO: 3), (Ac-KEQCVEMYTD-NH2)2 (SEQ ID NO: 4), Ac-KEQCVEMYTD-acid (SEQ ID NO: 5), H-KEQCVEMYTD-acid (SEQ ID NO: 6), Ac-KEQCVE-Nle-YTD-NH2 (SEQ ID NO: 7), Ac-KEQSVEMYTD-NH2 (SEQ ID NO: 8), Ac-KEQAVEMYTD-NH2 (SEQ ID NO: 9), Ac-SDGTPVNYTNWYRGEPAGRGKEQ-NH2 (SEQ ID NO: 10), Ac-GDFRYSDGTPVNYTNWYRGE-NH2 (SEQ ID NO: 11), Ac-WGKEQAVE-Nle-YTD-NH2 (SEQ ID NO : 12), Ac-WGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 13), Ac-RGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 14), and Ac-wGKEQCVE-Nle-YTD-NH2 (SEQ ID NO: 15).
28. 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: 5.
29. 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 claims 1-3 is the peptide of SEQ ID NO: 4 recited in claims 1-4 of US patent 11110152 B2 does not have N-terminal acetylation.
However, Peers et al teach that N-terminal modification such as protecting the N-terminal end of peptide with an acetyl group is common practice in the art of preparation of peptides having greater stability, particularly for in vivo use, for example, column 3, lines 8-26.
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: 5 recited in instant claims 1-3.
30. (Revised due to Applicant’s amendment to the claim) For the same/similar reasoning/rational as the rejection set forth in Sections 26-29 above, instant claims 1-3 remain provisionally rejected 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 (Notice of allowance mailed on 12/4/2025) and in view of Peers et al (US 5837218 A).
This is a provisional obviousness-type double patenting rejections because the conflicting claims have not in fact been patented.
Response to Applicant's Arguments
31. Applicant argues that “The presently claimed peptide now expressly includes a histidine N-terminal modification and a C-terminal acid group, which are not present in the peptide disclosed in the '152 patent.”
32. Applicant's arguments have been fully considered but have not been found persuasive.
Please note: in view of Applicant’s amendment to the claim and the claim interpretation as set forth in Section 8 above, Peers et al (US 5837218 A) is cited as a prior art reference in these ODP rejections.
In response to Applicant’s arguments about the ODP rejection over claims 1-4 of US patent 11110152 B2, in the instant case, as stated in Section 29 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: 5 recited in instant claims 1-3.
Furthermore, Applicant fails to address the ODP rejection over claims of co-pending Application No. 17/409642.
Taken all these together, until a proper terminal disclaimer is filed and approved by the Office, these double patenting rejections are hereby maintained.
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.
No claim is 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