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 .
Priority Claim
The instant application, filed on 14 August 2023, claims domestic benefit to US provisional application no. 63/398,113, filed on 15 August 2025.
Status of Application, Amendments, and/or Claims
The response filed on 14 August, 2023 has been entered in full. No amendments or withdrawals have been made. Therefore, claims 1-20 are pending and are the subject of this Office Action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 20, September, 2024 has been considered by the examiner.
Claim Rejections - 35 USC § 112(a) – Written Description
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.
Claim 1-20 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
Claims 1, 2, 8, 9, 15, and 16 recite claim to a picobody which comprises an N-terminal truncation of an alpha synuclein nanobody which binds alpha synuclein. This lays claim to any nanobody which binds to alpha synuclein which has been N-terminal truncated.
The instant disclosure, however, does not describe a representative number of species performing the claimed function, nor does the disclosure identify a structure function relationship that could be used to predictably identify which alpha synuclein binding nanobodies with a N-terminal truncation could be used in order to arrive at a picobody with the claimed function. The instant disclosure only supports possession of the studied picobody derived from the truncation of the NbM01 nanobody (paragraph 0016-0018). For the purpose of further examination, the claims will be interpreted to only claim the studied picobody derived from truncation of the NbM01.
The state of the art around the effective filling date of the claimed invention also does not provide a representative number or species or a predictable structure-function relationship to support the full scope of the claim and further teaches the involvement of N terminal residues in binding to alpha synuclein.
For example, Genst et al. (2010) Structure and Properties of a Complex of α-Synuclein and a Single-Domain Camelid Antibody J. Mol. Biol. (402) 326-343 (hereafter Genst) teaches the NMR characterization of the NbSyn2 (a nanobody which binds to alpha synuclein) binding to alpha synuclein (pg.332, col 2). Genst finds that a variety of resides take part in binding to alpha synuclein, including to some extent, residues in the framework region of the immunoglobulin fold, such as Gly2-Gly10 (pg.334, col 1, lines 18-21) which fall within the N-terminus including the 8 amino acid truncation claimed in claims 2, 9, and 16 of the instant application. Thus, removal of these residues would have unpredictable results on the binding affinity of the nanobody to alpha synuclein.
Turk et al. (2018) Exploring the role of post-translational modifications in regulating α-synuclein interactions by studying the effects of phosphorylation on nanobody binding Protein Science (27) 1262-1274 (hereafter Turk) teaches that NbSyn87 (a nanobody which binds to alpha synuclein) has a binding domain which is near the N-terminal region of the domain, and further that the N terminal of the nanobody undergoes resonance broadening when measured with HSQC (Figure 1). Thus, removal of these N-terminal would have unpredictable results on the binding affinity of the nanobody.
Overall, it is not evident from the instant disclosure or the prior art that the inventor was in possession of a representative number of picobodies comprising a nanobody which can bind to alpha synuclein with an N-terminal truncation. Therefore, a picobody comprising any N-terminal truncated nanobody which binds to alpha synuclein claimed in the instant claims does not meet the written description requirement.
Claims 3-7 are rejected due to their dependency on claim 1.
Claims 10-14 are rejected due to their dependency on claim 8.
Claims 17-20 are rejected due to their dependency on claim 15.
Claim Rejections - 35 USC § 112(a) – Written Description
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 1-20 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claims contain 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, at the time the application was filed, had possession of the claimed invention.
Claims 1, 2, 8, 9, 15, and 16 recite claim to a picobody which comprises an N-terminal truncation of an alpha synuclein nanobody which binds alpha synuclein. These claims are only enabled for the NbM01 derived picobody as outlined above. The claims and specification fail to provide a sequence and/or structure for nanobody NbM01 (of the specification) which would reasonably allow a person of ordinary skill in the art in possession of the invention to produce the NbM01 nanobody and subsequently the picobody of the claims. Therefore, the picobody claimed in the instant claims does not meet the written description requirement.
Claims 3-7 are rejected due to their dependency on claim 1.
Claims 10-14 are rejected due to their dependency on claim 8.
Claims 17-20 are rejected due to their dependency on claim 15.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DASIA A ALDARONDO whose telephone number is (571)272-1977. The examiner can normally be reached on Monday - Thursday from 7am to 4pm and Friday 7am to 11am.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Hama, can be reached at telephone number (571)272-2911. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/D.A.A/Examiner, Art Unit 1647
/JOANNE HAMA/ Supervisory Patent Examiner, Art Unit 1647