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 .
Claims 1-19 and 22 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 28, 2025 has been considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-3, 5-6, 8-9, 11-12, 14-19 and 22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims are drawn to An adeno-associated virus (AAV) targeting peptide comprising an amino acid sequence that comprises at least 4 contiguous amino acids from a sequence selected from the group consisting of PHEGSSR (SEQ ID NO: 169), LNNTKTT (SEQ ID NO: 237), SNLARNV (SEQ ID NO: 274) and TNINTKIPL (SEQ ID NO: 390).
Claims are rejected because they recite partial structure regarding the amino acid sequences of SEQ ID NO: 169, 237, 274 and 390. The peptides of SEQ ID NO: 169, 237, 274 and 390 are 7 amino acids in length and the claims require that the peptides comprising only 4, 5 or 6 contiguous amino acids of SEQ ID NO: 169, 237, 274 and 390 have a function of targeting the central nervous system (CSN). The claims lack structure and function correlation and are therefore rejected for lack of written description. Applicant’s specification fails to demonstrate that peptide having only 4, 5 or 6 amino acids of SEQ ID NO: 169, 237, 274 and 390 have a function of targeting the central nervous system (CSN). Claims 4, 7, 10 and 13 requiring the entire SEQ ID NO: 169, 237, 274 and 390 are not rejected.
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
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 1-19 and 22 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 pre-AIA the applicant regards as the invention.
Claim 1 is drawn to An adeno-associated virus (AAV) targeting peptide comprising an amino acid sequence that comprises at least 4 contiguous amino acids from a sequence selected from the group consisting of PHEGSSR (SEQ ID NO: 169), LNNTKTT (SEQ ID NO: 237), SNLARNV (SEQ ID NO: 274) and TNINTKIPL (SEQ ID NO: 390).
It is not clear what is the relationship between the adeno-associated virus (AAV) and PHEGSSR (SEQ ID NO: 169), LNNTKTT (SEQ ID NO: 237), SNLARNV (SEQ ID NO: 274) and TNINTKIPL (SEQ ID NO: 390)? Are the peptides derived from AAV?
Claim 15 recites The AAV targeting peptide wherein the targeting AAVF peptide is part of an AAV. It is not clear what does it mean that the peptides of PHEGSSR (SEQ ID NO: 169), LNNTKTT (SEQ ID NO: 237), SNLARNV (SEQ ID NO: 274) and TNINTKIPL (SEQ ID NO: 390) are parts of AAV. Are the peptides exogenous and incorporated within the AAV or are they derived from AAV?
Clarification and/or correction is required.
Claim 22 is drawn to A recombinant adeno-associated virus (rAAV), comprising an AAV targeting peptide of claim 1 any one of claims 1-17, or an AAV capsid protein of any one of claims 18-20.
The claim is multiple dependent from claims 18-20. Applicant may amend the claim to a single dependent claim or amend the claim in proper dependent form.
Correction is required.
Pertinent references
Esteves et al. (US Application Publication US 2020/0354714) teach AAV comprising the capsid selectively targeting the CNS tissue (see paragraphs [0011], [0123], and Example 2). Esteves et al. does not teach present PHEGSSR (SEQ ID NO: 169), LNNTKTT (SEQ ID NO: 237), SNLARNV (SEQ ID NO: 274) and TNINTKIPL (SEQ ID NO: 390).
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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