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 .
Application Status
Claims 1-12 are pending and examined on the merits herein.
Claim Objections
Claim 9 is objected to because of the following informalities:
Line 2 recites “a vector of comprising”, please delete the “of”
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 9 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the statement “use of” or “for use” of an invention without any meaningful steps for that use does not qualify as a process, machine, manufacture or composition of matter.
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.
Claim 9 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.
Claim 9 is drawn to use of the ECAR of claim 1, a nucleic acid encoding the ECAR, a vector encoding the nucleic acid, a host cell comprising the vector or a pharmaceutical composition comprising the ECAR for the preparation of a drug formulation for (a) selective killing of a cell and/ or (b) treating a disease. As the claim does not set forth any steps involved in the method/ process, it is unclear what method/ process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
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.
(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 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maus (WO 2018/132513 A1; PTO-892)
Regarding claims 1-2, Maus teaches a chimeric antigen receptor (CAR) polypeptide comprising: a) one or more extracellular domains comprising a portion of Tumor Necrosis Factor (TNF) superfamily receptor ligand; b) a hinge and transmembrane domain; c) a co- stimulatory domain; and d) an intracellular signaling domain (claim 1), wherein the TNF superfamily receptor ligand is A Proliferation-Inducing Ligand (APRIL) (claim 2).
Regarding claim 3, Maus teaches further comprising a CD8 leader sequence (claim 4), wherein the hinge and transmembrane domain comprises the hinge and transmembrane domain of CD8 or 4- IBB (claim 8), wherein the intracellular signaling domain comprises the signaling domain of CD3ζ, CD3s, or CD36 (claim 11), wherein the co- stimulatory domain is the intracellular domain selected from the group consisting of 4-1BB ICD, CD28 ICD, CD27 ICD, ICOS ICD, and OX40 ICD.(claim 14), yielding a an ECAR with a formula CD8 leader-TNFR ligand- CD8 hinge-CD8 transmembrane domain- 4-1BB costimulatory domain- CD3ζ intracellular signaling domain which corresponds to the instantly claimed formula L-Z1-Z2-TM-C- CD3ζ.
Regarding claims 4-6 and 12, Maus teaches a mammalian cell comprising; a) a CAR polypeptide of claim 1 ; b) a nucleic acid encoding a CAR polypeptide of claim 1 ; or c) a polypeptide complex comprising two or more of the CAR polypeptides of claim 1 (claim 24). Maus further teaches that a nucleic acid encoding a polypeptide as described herein (e.g. a CAR polypeptide) is comprised by a vector (para 0060).
Regarding claims 7 and 11, Maus teaches wherein the cell is a T cell (claim 25). Maus further teaches that Human primary T cells were lentivirally transduced with the CAR constructs (para 00224).
Regarding claims 8-9, Maus teaches a composition comprising the CAR polypeptide of claim 1 formulated for the treatment of cancer (claim 35), further comprising a pharmaceutically acceptable carrier (claim 36), a method of treating cancer, a plasma cell disorder, or an autoimmune disease in a subject, the method comprising administering a cell of claim 24 to the subject (claim 29).
Regarding claim 10, Maus teaches APRIL-CAR expressing T cells demonstrated specific killing of cells expressing BCMA and TACI (Fig. 12) and activation was similarly specific (Fig. 13). All of the components of a kit would be necessary to complete the method and therefore there is no patentable difference in supplying the materials in a container for a kit.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER K FAUST whose telephone number is (703)756-1661. The examiner can normally be reached Monday - Thursday 9:00am-6:00pm EST.
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/AMBER K FAUST/Examiner, Art Unit 1643
/JULIE WU/Supervisory Patent Examiner, Art Unit 1643
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