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 Application/Election/Restrictions
Applicant’s election with traverse of Group II (Claims 18-20) in the reply filed on 2/4/2026 is acknowledged. Applicant’s traversal is on the grounds that there is not a serious search burden to examine both the method and composition as claimed. This is not found persuasive because even though the inventions of these groups require the technical feature of a molecule circuit comprising a nucleic acid encoding a target protein, inactivating protein and actuating protein, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Silverman who discloses a molecular circuit within a cell comprising a target protein that compresses a regulatory motif that is not native to the target protein, an inactivating protein and an activating protein (Silverman, para 11, 13). As the common technical feature was known in the art at the time of the invention, this cannot be considered a common special technical feature that would otherwise unify the groups. Accordingly, unity of invention is lacking. Furthermore, it is emphasized that the search and examination of methods (Group 1, claims 1-17) is not coextensive with the search for compositions (Group II, claims 18-20), since the methods have manipulative steps that the compositions don’t have, and are evaluated differently under certain statues (i.e. 35 U.S.C 101 and 112 in particular). Accordingly, there is a search and examination burden to search these inventions in the same application. The requirement is still deemed proper and is therefore made FINAL.
Claims 1-20 are pending. Claims 1-17 are currently withdrawn from further consideration pursuant to 37 CFR 1.142 (b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 18-20 are the subject of the present Official action.
Priority
Applicant’s claim for the benefit of a prior-filed application PRO 63/136,560 and PCT/US2022/012033 filed on 1/12/2021 and 1/11/2022, respectively, under 35 U.S.C 119(e) or under 35 U.S.C 120, 121 or 365(c) is acknowledged.
Accordingly, the effective priority date of the instant application is granted as 1/12/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/26/2023 were received. The submissions were in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements were considered by the examiner.
Claim Objections
Claim 18 is objected to for depending on withdrawn claim 1. Amending claim 18 to incorporate the limitations of claim 1 would be remedial.
Claim Interpretation
Although claim 18 depends on withdrawn claim 1 is improper, the limitations from claim 1 are nonetheless considered in the claim interpretation of claims 18-20.
Furthermore, a nucleic acid encoding a target protein that comprises a regulatory motif that is not native to the target protein is interpreted as reading on not part of the protein in its wild type if the protein is otherwise naturally occurring such as a transgene (Spec, detailed description of the invention).
Claim Rejections - 35 USC § 112a, 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 18-20 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. This rejection is supported by Silverman et al. US 2014/0128287, published 5/8/2014, priority date 3/30/2012 (hereinafter Silverman).
The genus of “target protein”, “inactivating protein”, “actuating protein” and “controller protein” refers to genera that are considered extraordinarily broad. It is thought to encompass any protein both known and yet to be discovered. It encompasses all transcriptional regulators, metabolic regulators, signal transduction proteins, maintenance proteins, and therapeutic proteins.
For each claim drawn to a genus, the written description requirement may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in procession of the claimed genius. If a representative number of adequately descried species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The instant specification exemplifies specific types of target proteins, inactivating proteins, actuating proteins and controller proteins. For example, the specification describes inactivating proteins which may be a protease that cleaves at the protease cleavage site and activates a degron, which causes the degradation of a target protein (Spec, detailed description of the invention). This is not considered a representative number of samples to support the claim to all types of target proteins, inactivating proteins, actuating proteins and controller proteins because of the expansive nature of the genus which encompasses virtually all proteins that accomplish the broad functional objectives.
Given the breadth of the genera in contrast to the exemplified and prophetic proportions of the specification, which are largely drawn to specific classes of protease and degrons, the instant specification does not adequately disclose a sufficient number of adequately described species to support the claimed genera.
Furthermore, the prior art does not support the breadth of applicants claim to all types of target proteins, inactivating proteins, actuating proteins and controller proteins. In particular, the prior art reveals that specific proteins and regulatory motifs work in conjunction and are frequently inoperable. This is supported by Silverman where in specific protease and degron systems are explored to regulate gene circuits. Silverman shows that there is a great deal of unpredictability in the art, wherein only specific inactivating proteins, regulatory motifs and external stimuli are compatible with one another (Silverman, para 61-80).
Thus, although the specification prophetically considers and discloses specific target proteins, inactivating proteins, actuating proteins and controller proteins, the instant specification does not disclose a sufficient number of adequately described species to support the claim to all imagined target proteins, inactivating proteins, actuating proteins and controller proteins.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Silverman et al. US 2014/0128287, published 5/8/2014, priority date 3/30/2012 (hereinafter Silverman).
Claim 18: Silverman describes a method comprising exposing a eukaryotic cell to a first external stimulus comprising a hormone which activates the expression of a target protein and an inactivating protein in a molecular circuit (Silverman, para 13, 77). Silverman describes a nucleic acid encoding a target protein that comprises a regulatory motif that is not native to the target protein, with preferred embodiments to a modified degron hormone binding domain sequence at the initiator codon of the open reading frame (Silverman, para 12, 13, 19 and 25). Silverman describes a nucleic acid encoding an inactivating protein, wherein the inactivating protein binds to the regulatory motif and inactivates the target protein with preferred embodiments to a protease-encoding gene that expresses a protease that is capable of hydrolyzing the target protein to yield a protein having an N-end rule destabilizing amino acid at the amino terminus (Silverman, para 13). The protease cleaves the dormant N-degron to initiate N-end rule degradation of the target protein (Silverman, para 11). Silverman further describes an actuating protein that, in response to a first external stimulus, independently activates expression the target protein and the inactivating protein, with preferred embodiments to a transcriptional activator comprising a DNA-binding domain and a hormone-binding domain (Silverman, para 13).
Claim 19: Silverman describes the use of a chimeric hormone transcription factor called GEV which contains a DNA binding domain, a hormone binding domain and a highly electronegative portion of herpes simplex virus protein VP16 which confers strong transcriptional activity (Silverman, para 9). GEV controls both the protease (inactivating protein) and the target protein (Silverman, para 61). Silverman describes the use of various promoters used to control the expression of GEV (Silverman, para 69-70). Silverman describes the use of a second external stimulus which modulates the controller protein, with preferred embodiments to β-estradiol (Silverman, para 9, 166, 179 and claim 3).
Claim 20: Silverman describes expression in vitro, ex vivo and in vitro (Silverman, para 60).
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. ALEXANDER NICOL whose telephone number is (571)272-6383. The examiner can normally be reached on M-F 8-5 EST.
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Alexander Nicol
Patent Examiner
Art Unit 1633
/ALEXANDER W NICOL/Examiner, Art Unit 1634