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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11, in the reply filed on 6/2/2026 is acknowledged.
Claims 12-17, 19-21, 24, and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/2/2026.
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In response to the species election as shown follows, applicant merely elects “a linear peptide having the amino acid sequence of QQ(pY)F” is very general without following the restriction requirement to further limit the claim scope of claim 1.
For compact prosecution purposes, the examiner selects SEQ ID NO: 64 (RQQ(pY)FKQN) in the specification [00117, Table 1] on the merit for examination because applicant failed to do proper species election by “electing a single and completely defined linear peptide sequence with SEQ ID NO”. Other peptide sequences not comprising SEQ ID NO: 64 are withdrawn. SEQ ID NO: 64 does not contain non-naturally occurring amino acids or D-amino acids; thus claims 2, 7-8 are further withdrawn. Since SEQ ID NO: 64 is examined on the merit, any subsequent claim amendment conflicts with SEQ ID NO: 61 in response to this office action would be considered non-compliance amendment during the entire prosecution of this application.
Claim Status
Claims 1-17, 19-21, 24, and 26 are pending.
Claims 18. 22-23, 25, and 29-30 are cancelled.
Claims 2-5, 7-8, 12-17, 19-21, 24, and 26 are withdrawn, the election having been made on 6/2/2026.
Claims 1, 6, and 9-11 have been examined.
Priority
This application is a 371 of PCT/US2022/022559 03/30/2022
PCT/US2022/022559 has PRO 63/168,901 03/31/2021
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 9/29/2023 and 10/26/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Sequence Compliance
Specification
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR 1.821 through 1.825 for the reason(s) set forth below or on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Sequence ID numbers are required amino acid sequence of 4 or more amino acids. At least the peptide sequence of QQpYF found at para [0065-0066, 00252, 00255-00256, 002787-00279] in the specification requires a SEQ ID NO.
Applicant is given THREE MONTH to comply with the requirements of sequence compliance together with response to this office action, from the mailing date of this letter within which to comply with the sequence rules, 37 CFR 1.821 - 1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 CFR 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 CFR 1.136(a). In no case may an applicant extend the period for reply beyond the SIX MONTH statutory period. Direct the reply to the undersigned. Applicant is requested to return a copy of the attached Notice to comply with the reply.
Claim Objections
Claims 1 and are is objected to because of the following informalities:
Claim 1 contains a peptide sequence of QQ(pY)F, but missing a peptide sequence ID number for the peptide.
Claim 9 references to Table 1. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). See MPEP 2173.05(s).
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Haan et al. (J Biol Chem. 1999 Jan 15;274(3):1342-8, cited in IDS).
Claim 1 is drawn to an isolated peptide of 4-50 amino acids comprising the sequence QQ(pY)F.
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Haan et al. show a phosphorylated peptide pY814 comprising QQ(pY)F (p1346, Table IV) and reading on various peptide sequences including the peptide sequence of SEQ IDS NO: 64 examined on merit and other peptide sequences listed in Table 1 as shown follows, reading on claims 1 and 9.
With respect to claim 10, Haan et al. teach a pharmaceutical composition comprising the phosphorylated peptide pY814 and phosphate-buffered saline (p1343, col 1, Peptide binding Assay).
Claims 1 and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hornbeck et al. (US 2009/0258436 A1).
Claim 1 is drawn to an isolated peptide of 4-50 amino acids comprising the sequence QQ(pY)F.
Hornbeck et al. show a phosphorylated peptide of SEQ ID NO: 120 comprising QQ(pY)F as shown follows, reading on claim 1.
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With respect to claim 10, Hornbeck et al. teach injection of a pharmaceutical composition comprising an antigen, for example phosphorylated peptide of SEQ ID NO: 120, in a solution as a pharmaceutically acceptable carrier into a mouse or other species to raise monoclonal antibodies [0132].
Claim Rejections - 35 USC § 103
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.
1. Claims 1, 6, and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Haan et al. as applied to claims 1, 9-10 and further in view of Linse (https://www.biosyn.com/tew/cell-penetrating-peptide-delivers-proteins-into-cells.aspx).
Claim 6 is drawn to the peptide further comprising a cell penetrating peptide (CPP or PTD) sequence.
Haan et al. teach pY814 comprising QQ(pY)F (p1346, Table IV), a phosphorylated peptide from gp130 (p1347, col 1, para 2; Fig 7A), able to bind the SH2 domain of STAT1 and STAT3 to modulate cellular signal transduction pathways (p1342, col 1, last para to col 2, para 1-3).
Haan et al. did not teach how to deliver the phosphorylated peptide into cells using a cell penetrating peptide as a delivery vector.
Linse teaches cell-penetrating peptides, or CPPs, are short peptides that can facilitate cellular uptake of a variety of molecular cargo. Linse teaches CPP peptides can penetrate cell membranes either alone or along with cargo molecules of peptides and proteins (p1, para 1). Because Linse suggests cell-penetrating peptide (e.g., Tat) can facilitate cellular uptake a peptide (e.g., Haan et al. teach pY814 peptide), one of ordinary skill in the art would have found it obvious to beneficially combine Linse’s cell-penetrating peptide and Haan’s pY814 peptide to enhance cellular uptake the conjugated peptide.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Haan’s pY814 peptide with Linse’s cell-penetrating peptide because (a) Haan et al. suggest, a phosphorylated peptide pY814 comprising QQ(pY)F (p1346, Table IV) able to bind the SH2 domain of STAT1 and STAT3 to modulate cellular signal transduction pathways inside cells (p1342, col 1, last para to col 2, para 1-3) and (b) Linse teaches CPPs can beneficially facilitate cellular uptake of a variety of molecular cargo of peptides and proteins (p1, para 1). The combination would have reasonable expectation of success because Linse teaches CPPs can beneficially facilitate cellular uptake of peptides and proteins (p1, para 1).
Claims 1 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Haan et al. as applied to claims 1, 9-10 and further in view of Evseenko (WO 2019/169135 A1).
Claim 11 s drawn to the pharmaceutical composition further comprising a compound of
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Haan et al. suggest a phosphorylated peptide pY814 comprising QQ(pY)F (p1346, Table IV) able to bind the SH2 domain of STAT1 and STAT3 to modulate cellular signal transduction pathways inside cells (p1342, col 1, last para to col 2, para 1-3).
Haan et al. did not explicitly teach a pharmaceutical composition further comprising the claimed compound.
Evseenko teaches methods and compositions for treating disease and disorders associated
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with gp130 activity (Abstract). Evseenko teaches the administered compound to modulate STAT3 signaling [0008, 0040]. Evseenko shows the administered compound B805 to modulate STAT3 signaling with the structure as shown follows [0035, claim 6, Fig 26]. Because both Haan’s phosphorylated peptide pY814 comprising QQ(pY)F (p1346, Table IV) and Evseenko’s compound of B805 are able to modulate STAT3 signaling [0035, claim 6, Fig 26], one of ordinary skill in the art would have found it obvious to combine both compounds for the same purpose of modulating STAT3 signaling, reading on claim 11.
One of ordinary skill in the art before the effective filing date of this invention would have found it obvious to combine Haan’s phosphorylated peptide pY814 comprising QQ(pY)F and Evseenko’s compound of B805 because (a) Haan et al. suggest a phosphorylated peptide pY814 comprising QQ(pY)F (p1346, Table IV) able to bind the SH2 domain of STAT1 and STAT3 to modulate cellular signal transduction pathways inside cells (p1342, col 1, last para to col 2, para 1-3) and (b) Evseenko teaches administration of a compound (e.g., B805) for the same purpose to modulate STAT3 signaling [0008]. The combination would have reasonable expectation of success because both Haan’s phosphorylated peptide pY814 comprising QQ(pY)F (p1346, Table IV) and Evseenko’s B805 able to modulate STAT3 signaling.
Statutory Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 6, and 9-11 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 6, and 9-11 of copending Application No. PCT/US22/22559.
This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Non-Statutory Double Patenting
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11/420,964 B2 (the ‘964 patent) in view of Haan et al. (J Biol Chem. 1999 Jan 15;274(3):1342-8, cited in IDS) and Evseenko (WO 2019/169135 A1).
Claim 1 of the ‘964 patent disclosed a compound 805 structure.
Claim 1 of the ‘964 patent did not disclose a composition comprising the compound 805 and a phosphorylated peptide pY814 comprising QQ(pY)F.
The relevancy of Haan et al. in view of Evseenko described above not repeated here.
Because Haan et al. in view of Evseenko teach beneficial combination of the compound 805 and a phosphorylated peptide pY814 comprising QQ(pY)F for the same purpose of modulating STAT3 signaling, one of ordinary skill in the art would have found it obvious to combine the compound 805 taught by claim 1 of the ‘964 patent with Haan’s phosphorylated peptide pY814 comprising QQ(pY)F.
Thus, claim 1 of the ‘964 patent in view of Haan et al. and Evseenko are obvious to the instant claims 1 and 9-11.
Claims 1 and 9-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12/577,238 B2 (the ‘238 patent) in view of Haan et al. (J Biol Chem. 1999 Jan 15;274(3):1342-8, cited in IDS) and Evseenko (WO 2019/169135 A1).
Claim 1 of the ‘238 patent disclosed a compound 805 structure.
Claim 1 of the ‘238 patent did not disclose a composition comprising the compound 805 and a phosphorylated peptide pY814 comprising QQ(pY)F.
The relevancy of Haan et al. in view of Evseenko described above not repeated here.
Because Haan et al. in view of Evseenko teach beneficial combination of the compound 805 and a phosphorylated peptide pY814 comprising QQ(pY)F for the same purpose of modulating STAT3 signaling, one of ordinary skill in the art would have found it obvious to combine the compound 805 taught by claim 1 of the ‘238 patent with Haan’s phosphorylated peptide pY814 comprising QQ(pY)F.
Thus, claim 1 of the ‘238 patent in view of Haan et al. and Evseenko are obvious to the instant claims 1 and 9-11.
Claims 1 and 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6 of copending Application No. PCT/US19/20058 (the ‘058 application, 8/17/2022) in view of Haan et al. and Evseenko.
Claims 1 and 6 of the ‘058 application disclosed a compound 805 structure.
Claims 1 and 6 of the ‘058 application did not disclose a composition comprising the compound 805 and a phosphorylated peptide pY814 comprising QQ(pY)F.
The relevancy of Haan et al. in view of Evseenko described above not repeated here.
Because Haan et al. in view of Evseenko teach beneficial combination of the compound 805 and a phosphorylated peptide pY814 comprising QQ(pY)F for the same purpose of modulating STAT3 signaling, one of ordinary skill in the art would have found it obvious to combine the compound 805 taught by claims 1 and 6 of the ‘058 application with Haan’s phosphorylated peptide pY814 comprising QQ(pY)F.
Thus, claims 1 and 6 of the ‘058 application in view of Haan et al. and Evseenko are obvious to the instant claims 1 and 9-11.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/J.L/Examiner, Art Unit 1658
08-August-2026
/Melissa L Fisher/ Supervisory Patent Examiner, Art Unit 1658
Prosecution Insights