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 .
Status of the Claims
Claims 1-18 were originally filed September 11, 2023.
The amendment received May 5, 2026 amended claim 1 and canceled claim 2.
Claims 1 and 3- 18 are currently pending.
Claims 1, 3, and 5 are currently under consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1-7 and 10) in the reply filed on May 5, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8, 9, and 11-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected product and a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 5, 2026.
Applicant’s election of SEQ ID NO: 36 and myristoyl as the species in the reply filed on May 5, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 4, 6, 7, and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 5, 2026.
Potential Rejoinder
Applicant elected claims directed to a product. If a product claim is subsequently found allowable, withdrawn process claims that depend from or otherwise include all the limitations of the allowable product claim will be rejoined in accordance with the provisions of MPEP § 821.04. Process claims that depend from or otherwise include all the limitations of the patentable product will be entered as a matter of right if the amendment is presented prior to final rejection or allowance, whichever is earlier. Amendments submitted after final rejection are governed by 37 CFR 1.116; amendments submitted after allowance are governed by 37 CFR 1.312.
In the event of rejoinder, the requirement for restriction between the product claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all the criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103, and 112. Until an elected product claim is found allowable, an otherwise proper restriction requirement between product claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowed product claim will not be rejoined. See “Guidance on Treatment of Product and Process Claims in light of In re Ochiai, In re Brouwer and 35 U.S.C. § 103(b),” 1184 O.G. 86 (March 26, 1996). Additionally, in order to retain the right to rejoinder in accordance with the above policy, applicant is advised that the process claims should be amended during prosecution either to maintain dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to a rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Priority
The present application is a CIP of 17/394,431 filed August 5, 2021 (now U.S. Patent 11,753,453) which is a CON of 16/486,832 filed August 18, 2019 which is a 371 (National Stage) of PCT/IL2018/050182 filed February 19, 2018 which claims the benefit of 62/460,810 filed February 19, 2017.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/394,431, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 17/394,431 only discloses 35 sequences (i.e. presently claimed SEQ ID NOs: 36 and 37 do not have support in application No. 17/394,431). In addition, an alanine at position 8 (i.e. present SEQ ID NO: 36) is not disclosed in application No. 17/394,431. Therefore, the present claims have a priority date of the filing date of the present application (i.e. September 11, 2023).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on September 11, 2023 and May 16, 2024 are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: U.S. Patent 11,753,453 should be added to the first line of the specification.
Appropriate correction is required.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See page 21, lines 9 and 10.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Claim Rejections - 35 USC § 112
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.
Claim 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. One of skill in the art would not be able to determine the scope of the present claim. For example, it is unclear what the scope of “is” is (e.g. open, closed, etc.). Utilization of comprising, consisting of, or a specific percent identity is suggested.
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, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jayaram et al., 2021, Unraveling the hidden role of a uORF-encoded peptide as a kinase inhibitor of PKCs, PNAS, 118(40): 11 pages (provided by applicants in the IDS).
For present claims 1, 3, and 5, Jayaram et al. teach MASRGALRRCLSPGLPRLLHLSRGLA (i.e. present SEQ ID NO: 36 with arginine at residue 8 instead of alanine; 96% identity) which is myristoylated (i.e. Myr) (please refer to the entire reference particularly Figure 1A; “Peptides” section).
Therefore, the teachings of Jayaram et al. anticipate the presently claimed peptide.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Livneh et al. WO 2018/150430 published August 23, 2018.
For present claims 1, 3, and 5, Livneh et al. teach SEQ ID NOs: 1 and 2 comprising MASRGALRRCLSPGLPRLLHLSRGLA (i.e. present SEQ ID NO: 36 with arginine at residue 8 instead of alanine; 96.2% identity) which is myristoylated (i.e. Myr) (please refer to the specification particularly pages 4, 8, 9, 12, 15 – lines 11-12; claims).
Therefore, the teachings of Livneh et al. anticipate the presently claimed peptide.
Claims 1, 3, and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Livneh et al. U.S. Patent Application Publication 2020/0231642 published July 23, 2020.
For present claims 1, 3, and 5, Livneh et al. teach SEQ ID NOs: 1 and 2 comprising MASRGALRRCLSPGLPRLLHLSRGLA (i.e. present SEQ ID NO: 36 with arginine at residue 8 instead of alanine; 96.2% identity) which is myristoylated (i.e. Myr) (please refer to the entire specification particularly Figures 1A and 1B; paragraphs 21, 22, 63, 78, 101; claims).
Therefore, the teachings of Livneh et al. anticipate the presently claimed peptide.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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