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 (i.e., claims 1-6 and 97 drawn to an engineered peptide comprising a p110beta targeting peptide and a delivery moiety that is coupled to the p110beta targeting peptide) in the reply filed on December 18, 2025, is acknowledged. Additionally, Applicant’s election without traverse of Species A (i.e., a single and specific engineered peptide as SEQ ID NO: 3 as a single and specific p110beta targeting peptide and SEQ ID NO: 6 as a single and specific delivery moiety where the engineered peptide does not include any ester-linked groups) in the reply filed on December 18, 2025, is acknowledged.
Please note that Species A is expanded to include where the engineered peptide include one or more ester-linked groups. Thus, claim 6 is hereby rejoined and examined on the merits.
Status of Claims
Claims 1-87 were originally filed on April 4, 2023.
The amendment received on October 17, 2023, canceled claims 7-87; and added claims 88-101. The amendment received on April 27, 2026, canceled claim 3; amended claims 1, 88-89, 92-94, and 97-98; and added new claim 102.
Claims 1-2, 4-6 and 88-101 are currently pending and claims 1-2, 4-6, and 97 are under consideration as claims 88-96 and 98-102 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 December 18, 2025.
Priority
The present application claims status as a 371 (National Stage) of PCT/US2021/054331 filed October 9, 2021, and claims priority under 119(e) to U.S. Provisional Application Nos. 63/090,121 filed on October 9, 2020, and 63/090,140 filed on October 9, 2020.
Sequence Interpretation
For claim 1, please note that the Examiner is interpreting the scope of the engineered peptide as open-ended requiring two components, i.e., a p110beta targeting peptide and a delivery moiety. However, the Examiner is interpreting the scope of the p110beta targeting peptide as closed-ended requiring 100% identity and the same length to SEQ ID NO: 3.
For claim 5, please note that the Examiner is interpreting the scope as open-ended requiring 100% identity to one of the recited sequences with any N- and/or C-terminal additions.
Claim Interpretation
For purposes of applying prior art, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation set forth below, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
For claims 1 and 4, with respect to where the delivery moiety is a cell penetrating peptide, it is noted that the instant specification does not define what constitutes a cell penetrating peptide as a delivery moiety. Thus, the plain and ordinary meaning of the term applies. Borrelli et al. defines cell penetrating peptides as a large class of short amino acid sequences (5-30 residues) that are able to traverse biological membranes and to deliver numerous compounds including small molecules, nucleic acids, proteins, viruses, imaging agents, and drugs inside cells (See Borrelli et al., Molecules 23:1-28 pages (2018) at pg. 1, 1st paragraph) (cited in the IDS received on 11/17/23). According to their origins, CPPs are classified as: (1) protein-derived CPPs such as the Tat protein and Penetratin, (2) chimeric CPPs such as Transportan derived from the binding of the neuropeptide galanin N-terminus to the Mastoparan toxin, and (3) synthetic CPPs comprising oligoarginines and numerous nucleic acids (PNAs) formed by synthetic nucleic acid analogues bound to pseudopeptide backbone (See Borrelli, pg. 2, 3rd paragraph). Borrelli et al. lists in Table 1, a number of synthetic CPPs that have been generated with chemical modifications that improve cellular uptake and provide cellular and sub-cellular specific targeting (Borrelli, pg. 4, 4th paragraph). As depicted in Table 1, there is a large list of CPP-derived molecules (See Borrelli, Table 1) (See also: Streiker et al. US Publication No. 2015/0297742 A1 published on October 22, 2015: teaching CPP(s) that comprise or consist of the amino acid sequence selected from SEQ ID NOs: 1 to 760 (See Streiker, [0067]) where SEQ ID NOs: 9 to 77 are preferred as depicted in Table 1 (see Streiker, [0080])). As such, given the disclosure of SEQ ID NOs: 4, 6 and 110-222 combined with the pre-existing knowledge in the art regarding CPPs, an ordinary skilled artisan would have put one in possession of the genus of CPPs as a delivery moiety in the engineered peptide. Thus, an ordinary skilled artisan would conclude that the applicant was in possession of the claimed genus of CPPs before the effective filing date of the instant application.
Response to Arguments
Applicant’s arguments, see Response, filed 4/27/26, with respect to the objections to the specification have been fully considered and are persuasive. The objections of the specification have been withdrawn.
Applicant’s arguments, see Response, filed 4/27/26, with respect to the claim objection have been fully considered and are persuasive. The objection of claim 97 has been withdrawn.
Applicant’s arguments, see Response, filed 4/27/26, with respect to the 112(a), written description, rejection have been fully considered and are persuasive. The rejection of claims 1-5 and 97 as failing to comply with the written description requirement have been withdrawn.
Applicant’s arguments, see Response, filed 4/27/26, with respect to the 102(a)(1) rejection have been fully considered and are persuasive. The rejection of claims 1-3 and 97 as being anticipated by Hirsch et al. US Patent No. 8,105,796 B2 issued on January 31, 2012, alone or as evidenced by Sjodin et al., Israel J. Chem. 63:e202300070 (2023) and/or Namiki et al., Biochem. Biophys. Res. Commun. 305:592-597 (2003) have been withdrawn.
Applicant’s arguments, see Response, filed 4/27/26, with respect to the 103(a) rejection have been fully considered and are persuasive. The rejection of claims 1 and 4-5 as being unpatentable over Hirsch et al. US Patent No. 8,105,796 B2 issued on January 31, 2012, alone or as evidenced by, Sjodin et al., Israel J. Chem. 63:e202300070 (2023) and/or Namiki et al., Biochem. Biophys. Res. Commun. 305:592-597 (2003), and further in view of Streiker et al. US Publication No. 2015/0297742 A1 published on October 22, 2015, alone or as evidenced by, Derossi et al., J. Biol. Chem. 30:18188-18193 (1996), and Guo et al., Biomedical Rep. 4:528-534 (2016) have been withdrawn.
New Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 6 recites where one or more amino acids of the engineered peptide comprises one or more ester linked groups. However, claim 6 is dependent upon or encompass the engineered peptide of claim 1. Although the engineered peptide comprises a p110beta targeting peptide and a delivery moiety, as discussed in the “Sequence Interpretation” section supra, the scope with respect to the p110beta targeting peptide is limited to SEQ ID NO: 3. Since the scope of claim 6 does not specify that the one or more ester linked groups (note: broadly encompasses any ester linked groups including amino acids) of the engineered peptide are linked to the delivery moiety alone or an unrecited component of the engineered peptide alone, the scope of claim 6 broadens the scope of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 1-2, 4-5, and 97 are allowed. It is noted that an engineered peptide comprising a p110beta targeting peptide consisting of (i.e., 100% identity and same length) SEQ ID NO: 3 is novel and nonobvious because there is no teaching or suggestion in the art to utilize a peptide sequence that is limited to SEQ ID NO: 3 (i.e., excludes the natural full length PI3Kβ protein sequence or a larger fragment). The closest prior art is Hirsch et al. US Patent No. 8,105,796 B2 issued on January 31, 2012 (cited in the Action mailed on 1/27/26). Hirsch et al. teaches a purified PI3Kβ protein comprising a gluthionine-S-transferase (GST) protein where the PI3Kβ protein comprises an amino acid sequence of SEQ ID NOs: 3 or 4 (See Hirsch, col. 11, 2nd paragraph). When comparing instant SEQ ID NO: 3 with Hirsch’s SEQ ID NO: 4, there is 100% identity with residues 413-430 of Hirsch’s SEQ ID NO: 4. However, Hirsch’s SEQ ID NO: 4 is now excluded from being encompassed given the transitional phrase “consisting of”. Therefore, the claimed engineered peptide is novel and nonobvious.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEA D' AMBROSIO whose telephone number is (571)270-1216. The examiner can normally be reached M-F 11:00 to 8:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THEA D' AMBROSIO/Primary Examiner, Art Unit 1654
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