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 1-14 were originally filed June 15, 2023.
Claims 1-14 are currently pending and under consideration.
Election/Restrictions
Upon further consideration, the restriction requirement is hereby withdrawn.
Priority
The present application claims status as 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 field 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.
Please note: the present application is a CON of 17/394,431 filed August 5, 2021 since the restriction requirement was withdrawn in the Notice of Allowance mailed May 1, 2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 15, 2023 and January 30, 2025 are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: the first line should include U.S. Patent 11,753,453.
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 lines 12-13 of page 22.
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.
Claim Objections
Claim 2 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. providing). Appropriate correction is required.
Claim 7 is objected to because of the following informalities: all acronyms should be spelled out with the first recitation of the acronym in the claims. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administering). Appropriate correction is required.
Claim 10 is objected to because of the following informalities: all method steps should be recited as active, positive steps (i.e. administering). Appropriate correction is required.
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.
Claims 1-14 are 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 claims. For example, it is unclear what the metes and bounds of “set forth as” are (see independent claims 1, 12, 13, and 14; i.e. open, closed, etc.). In addition, the combination of “comprising” language with “set forth as” in unclear. See the “Sequence Interpretation” section above.
Claim 2 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 claims. For example, it is unclear under what conditions the nucleic acid would be “capable of” expressing SEQ ID NO: 11 or SEQ ID NO: 12. Furthermore, it is unclear how the disease or condition could be treated if SEQ ID NO: 11 or SEQ ID NO: 12 were not actually expressed.
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, 2, and 9-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rubenfield et al. U.S. Patent 6,551,795 issued April 22, 2003.
For present claims 1, 2, and 9-14, Rubenfield et al. teach methods of administering SEQ ID NO: 22774 to humans directly or via gene therapy wherein administration is systemically, via injection, or orally and administration is daily (please refer to the entire specification).
Therefore, the teachings of Rubenfield et al. anticipate the presently claimed methods.
Allowable Subject Matter
Claims directed to a method of administering a composition comprising the amino acid sequence of SEQ ID NO: 11 or SEQ ID NO: 12 are free of the prior art.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang et al., 2009, Improved spatial learning in aged rats by genetic activation of protein kinase C in small groups of hippocampal neurons, Hippocampus, 19(5): 413-423.
Sun et al., 2009, Protein Kinase C Activators and Synaptogenic and Memory Therapeutics, Arch Pharm Chem Life Sci, 342: 689-698.
Sun et al., 2010, Pharmacology of protein kinase C activators: Cognition-enhancing and antidementic therapeutics, Pharmacology & Therapeutics, 127, 66-77.
Kodavanti, 2011, Cell Signaling and Neurotoxicity: Protein Kinase C In Vitro and In Vivo, Methods in Molecular Biology (Costa, Giordano, and Guizzetti editors), Chapter 21, pages 307-319.
Sun et al., 2015, Towards universal therapeutics for memory disorders, Trends in Pharmacological Sciences, 36(6): 384-394.
Yoshii et al., 2011, TfkB and Protein Kinase M z Regulate Synaptic Localization of PSD-95 in Developing Cortex, The Journal of Neuroscience, 31(33): 11894-11904.
Ciccocioppo et al., 2008, Expression and Phosphorylation of Protein Kinase C Isoforms in Ab1-42, Activated T Lymphocytes from Alzheimer’s Disease, International Journal of Immunopathology and Pharmacology, 21(1): 23-33.
Talman et al., 2016, Protein Kinase C Activation as a Potential Therapeutic Strategy in Alzheimer’s Disease: Is there a Role for Embryonic Lethal Abnormal Vision-like Proteins?, Basic & Clinical Pharmacology & Toxicology, 119: 149-160.
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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