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. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the cited rejections will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
3. Response to Election/Restriction filed on 6/5/2026 is acknowledged.
4. Claim filed on 6/5/2026 is acknowledged.
5. Claims 14-35 have been cancelled.
6. New claim 36 has been added.
7. Claims 1-13 and 36 are pending in this application.
8. Claims 4-10, 12 and 13 are withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim.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 6/5/2026. Claim 11 is withdrawn from consideration as being drawn to non-elected species.
Please note: During the search for the elected species of dosing regimen, prior art was found for the non-elected species of dosing regimen recited in instant claim 3. Therefore, for the purpose of compact prosecution, claim 3 is examined in the current office action.
9. Claims 1-3 and 36 are under examination.
Election/Restrictions
10. Applicant’s election with traverse of Group 1 (claims 1-3, 11 and 36) and election with traverse of wherein the treatment cycle comprises administering an effective amount of the EPO-derived peptide daily for 7-14 days recited in claim 2 as species of dose regimen; and the EPO-derived peptide GCAEHCSLNENITVPDTKV (SEQ ID NO: 1) as species of EPO-derived peptide in the reply filed on 6/5/2026 is acknowledged. The traverse is on the ground that the Examiner has not shown that there is a serious burden. This is not found to be persuasive. For US 371 of PCT application, burden is not a reason for traverse. Therefore, Applicant’s arguments are moot. And the requirement is deemed proper and is thereof made FINAL in this office action.
Group 1 is drawn to a dosing regimen comprising at least one treatment cycle followed by a rest phase, wherein the treatment cycle comprises administering an effective amount of an erythropoietin (EPO)-derived peptide to allow for a sustained therapeutic effect after withdrawal of the EPO-derived peptide, wherein the EPO-derived peptide is not administered during the rest phase. A search was conducted on the elected species; and prior art was found. Claim 11 is withdrawn from consideration as being drawn to non-elected species. Claims 1-3 and 36 are examined on the merits in this office action.
Specification
11. 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).
Objections
12. Claim 1 is objected to for the following minor informality: Applicant is suggested to amend claim 1 as “…wherein the treatment cycle comprises administering an effective amount of an erythropoietin (EPO)-derived peptide to allow for a sustained therapeutic effect after withdrawal of the EPO-derived peptide, and wherein the EPO-derived peptide is not administered during the rest phase”.
13. Claim 2 is objected to for the following minor informality: Applicant is suggested to amend claim 2 as “The dosing regimen of claim 1, wherein in the treatment cycle, the EPO-derived peptide is administered daily for 7-14 days”.
14. Claim 3 is objected to for the following minor informality: Applicant is suggested to amend claim 3 as “…wherein the dosing regimen further comprises a second treatment cycle after the rest phase”.
Rejections
Claim Rejections - 35 U.S.C. § 112 paragraph (b)
15. 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.
16. Claim 36 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.
17. Claim 36, which depends on claim 1, recites the limitation “The method of claim 1…”. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not mention a method. It is not clear to what the said phrase is referring.
Claim Rejections - 35 U.S.C. § 102(a)(1)
18. 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.
19. Claims 1-3 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yuan et al (Neurotherapeutics, 2015, 12, pages 850-861, filed with IDS).
The instant claims 1-3 and 36 are drawn to a dosing regimen comprising at least one treatment cycle followed by a rest phase, wherein the treatment cycle comprises administering an effective amount of an erythropoietin (EPO)-derived peptide to allow for a sustained therapeutic effect after withdrawal of the EPO-derived peptide, wherein the EPO-derived peptide is not administered during the rest phase.
Yuan et al, throughout the literature, teach EPO plays an important role as a renal hormone that regulates hematopoiesis by binding and stimulating erythroid progenitor cell proliferation in the bone marrow; also possesses other diverse biological functions, including antiinflammatory, antiapoptotic, and tissue protective effects; and is protective in several animal models of neurologic injury, including experimental autoimmune encephalomyelitis (EAE), traumatic brain injury and stroke; and JM-4 (an EPO-derived peptide) shows promise for treatment of a broad spectrum of neural and non-neural conditions associated with inflammation, for example, Abstract; and Introduction. Yuan et al further teach a dosing regimen comprising one treatment cycle followed by a rest phase, wherein the treatment cycle comprises administering an effective amount of JM-4 peptide daily for 7 days to allow for a sustained therapeutic effect after withdrawal of the JM-4 peptide, wherein the JM-4 is not administered during the rest phase, wherein the dosing regimen further comprises a second treatment cycle after the rest phase, and wherein the JM-4 peptide consists of the amino acid sequence GCAEHCSLNENITVPDTKV (identical to the EPO-derived peptide of instant SEQ ID NO: 1), for example, page 851, left column, Section “EPO and Peptides”; and page 855, Figure 3. It reads on wherein the treatment cycle comprises administering an effective amount of the EPO-derived peptide daily for 7-14 days recited in claim 2 as the elected species of dose regimen; and the EPO-derived peptide GCAEHCSLNENITVPDTKV (SEQ ID NO: 1) as the elected species of EPO-derived peptide. And it meets the limitations of instant claims 1-3 and 36.
Since the reference teaches all the limitations of instant claims 1-3 and 36; the reference anticipates instant claims 1-3 and 36.
Obviousness Double Patenting
20. 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.
21. Claims 1-3 and 36 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4 of US patent 8653028 B2 and in view of Yuan et al (Neurotherapeutics, 2015, 12, pages 850-861, filed with IDS).
22. Instant claims 1-3 and 36 are drawn to a dosing regimen comprising at least one treatment cycle followed by a rest phase, wherein the treatment cycle comprises administering an effective amount of an erythropoietin (EPO)-derived peptide to allow for a sustained therapeutic effect after withdrawal of the EPO-derived peptide, wherein the EPO-derived peptide is not administered during the rest phase.
23. Claims 1-4 of US patent 8653028 B2 are drawn to an isolated peptide consisting of the amino acid sequence of SEQ ID NO: 7; and pharmaceutical compositions comprising such isolated peptide.
The isolated peptide of SEQ ID NO: 7 recited in claims 1-4 of US patent 8653028 B2 is identical to the EPO-derived peptide of instant SEQ ID NO: 1.
24. The difference between instant claims 1-3 and 36 and claims 1-4 of US patent 8653028 B2 is that claims 1-4 of US patent 8653028 B2 do not teach apply the isolated peptide and/or the pharmaceutical composition recited in claims 1-4 of US patent 8653028 B2 in the dosage regimen recited in instant claims.
However, in view of the teachings of Yuan et al as set forth in Section 19 above, it would have been obvious to one of ordinary skilled in the art to apply the isolated peptide and/or the pharmaceutical composition recited in claims 1-4 of US patent 8653028 B2 and develop the dosage regimen recited in instant claims 1-3 and 36.
25. For the same and/or similar reasoning/rational as the rejection set forth in Sections 21-24 above, instant claims 1-3 and 36 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US patent 9345745 B2, claims 1 and 2 of US patent 9585932 B2, claims 1-18 of US patent 9765128 B2, claims 1-17 of US patent 10010583 B2, and claims 1-12 of US patent 10047132 B2; and in view of the teachings of Yuan et al (Neurotherapeutics, 2015, 12, pages 850-861, filed with IDS) as set forth in Section 19 above.
26. For the same and/or similar reasoning/rational as the rejection set forth in Sections 21-24 above, instant claims 1-3 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-7 of US patent 11559565 B2; and in view of the teachings of Yuan et al (Neurotherapeutics, 2015, 12, pages 850-861, filed with IDS) as set forth in Section 19 above.
Conclusion
No claim is allowed.
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/LI N KOMATSU/Primary Examiner, Art Unit 1658
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