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 .
Election/Restrictions
Applicant's election with traverse of Group 4 in the reply filed on 05/05/2026 is acknowledged. The traversal is on the ground(s) that it would not be unduly burdensome to perform a search on all of the claims together in the present application. This is not found persuasive because the issue of search burden is a restriction-related issues addressed in applications filed under 35 USC 111(a) whereas a lack of unity was presented in this application. The analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371 (unity of invention analysis) as compared to national applications filed under 35 U.S.C. 111(a).
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-24 are currently pending.
Claims 1, and 8-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 2-7, and 21-24 are currently pending and under consideration.
Claim Objections
Claim 2 objected to under 37 CFR 1.75 as being a substantial duplicate of claim 23. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 2 is also objected to for reciting “binds to the target dimerization with” as the word “domain” appears to be missing between “dimerization” and “with”.
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 21-24 and 2-7 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.
The term “binds with a low affinity” in claim 21 is a relative term which renders the claim indefinite. “Binds with a low affinity” is not defined by the claim (or dependent claims thereof). To what extent would one define the metes and bounds of low in terms of binding? The specification teaches [0063] that in many cases the relative degree of affinity will depend on the type of dimerization domain employed and, to an extent, the various types of modifications to those domains. However, such examples do not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 states “wherein the first dimerization domain binds to the target dimerization [domain] with a low affinity”. However, claim 2 is directly dependent from claim 21 which already states that the first dimerization domain binds to the target dimerization domain with a low affinity. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 21-24, and 2-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (WO2019118518, published June 2019, IDS).
Regarding claims 21-22, and 24, Lee et al. teach a method for inducing degradation of a target protein, comprising introducing a first cell to a second cell, wherein the first cell comprises a fusion protein (a multi-chain CAR with an OFF or ON switch) comprising an extracellular domain comprising a binding moiety that is capable of specifically binding to a cell marker [0022], a transmembrane domain [0023] and an intracellular domain comprising a dimerization domain (also referred to as a “recruitment domain”; see para 0109 of Lee et al.) that specifically binds to a corresponding “target” dimerization domain in a target protein. Lee et al. teach [0129] that these recruitment domains are protein domains that bind to each other and thus, can bring together two different polypeptides. Lee et al. teach that non-limiting examples of pairs of recruitment domains include (a) FK506 binding protein (FKBP) and FKBP; (b) FKBP and calcineurin catalytic subunit A (CnA); (c) FKBP and cyclophilin; (d) FKBP and FKBP-rapamycin associated protein (FRB); (e) gyrase B (GyrB) and GyrB; (f) dihydrofolate reductase (DHFR) and DHFR; g) DmrB and DmrB; (g) PYL and ABI; (h) Cry2 and CIP; and (i) GAI and GID1. Some of these recruitment domains are identical to the exemplary “dimerization” domains detailed in the current application. For example, the specification teaches [0090] that examples of pairs of protein domains that conditionally dimerize with one another include: FKBP and FKBP (which dimerize in the presence of rapamycin), FKBP and CnA (which dimerize in the presence of rapamycin), FKBP and cyclophilin (which dimerize in the presence of rapamycin), FKBP and FRG (which dimerize in the presence of rapamycin), or GyrB and GyrB (which dimerize in the presence of coumermycin), DHFR and DHFR (which dimerize in the presence of methotrexate). Lee et al. further teach [0139, 0115] that the fusion construct can contain a degradation domain wherein the degradation domain is a degron or E3-ligase recruiting domain.
Lee further teaches [0026, 0086, 0129-0130] a “target protein” within the same cell wherein the target protein is a chimeric antigen receptor that comprises an extracellular binding domain comprising a second binding moiety that is capable of specifically binding to a second cell surface maker, a transmembrane domain, and an intracellular domain that comprises a target dimerization domain to which the first dimerization domain of the fusion protein binds with a low affinity. Regarding the “second cell”, Lee et al. teaches [0194] that the present disclosure provides a type of cell therapy where immune cells are genetically modified to express an inducible cell receptor provided herein and the modified immune cells are administered to a subject in need thereof. Thus, when administered to a subject, the genetically modified immune cells would naturally contact the second cell in vivo which could be a non-cancerous cell.
Regarding Claims 23 and 3, Lee et al. teach [0180] that the first and second dimerization domains can be synthetic leucine zipper domains.
Regarding claim 2, due to the indefiniteness of “binds with a low affinity” and because the prior art teaches the same dimerization domains as that which is claimed (e.g., synthetic leucine zipper domains) the low affinity interactions/binding would be inherent.
Regarding claim 4, the specification teaches [0063] that synZIPs are around 30 amino acids in length and are composed of eight α-helical turns. Lee teaches that SYNZIP1 to SYNZIP 48 can be used as recruitment domains. Thus, the SYNZIPs of the prior art would have up to seven α-helical turns.
Regarding Claims 5 and 6, Lee et al. teach [0139] that the degradation domains can be degrons or an E3 ligase recruiting domain.
Regarding Claim 7, Lee et al. teach that the extracellular domain of the fusion protein can comprise a scFv [0168].
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
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/GARY B NICKOL/Primary Examiner, Art Unit 1643
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