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 .
Claim Status
Claims 1 – 3, 6, 11, 30, 34, 51, 74, 76, 80, 84, 85, 90, 97, 111, 119 and 124 are pending in this application.
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 (i.e., changing from AIA to pre-AIA ) 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)(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 – 3, 6, 11, 30, 34, 51, 74, 76, 80, 84, 85, 90, 97, 111, 119 and 124 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Tareen et al. (W.O. Patent Application No. 2017/068419, cited on IDS), hereinafter Tareen.
Regarding claims 1, 3, 30 and 124, Tareen teaches a method of on-column transduction [paragraph 0357] of T cells [paragraphs [0045 and 0046] that includes:
Contacting a plurality of target cells [paragraph [0005], in some embodiments, the target cells are T cells [paragraphs [0045 and 0046]; claim 123, pg. 252] simultaneously [paragraph [0010] with a T cell stimulatory reagent and a viral vector [Examples 21 – 23, paragraphs [0607 – 0623]].
A nucleic acid sequence encoding a recombinant protein [paragraph 612, a nucleic acid encoding a heterologous molecule (in this case an exemplary chimeric antigen receptor (CAR)].
T cells are immobilized on a stationary phase comprised in an internal cavity of a chromatography column [claims 159, pg. 258; claims 184 and 185, pg. 262].
Incubating the plurality of the T cells in the presence of the T cell stimulatory reagent and the viral vector [Examples 21 – 23, paragraphs [0607 – 0623]]; and
within 24 hours of contacting [claim 29, pg. 239], collecting the plurality of T cells from the chromatography column, thereby producing a composition comprising T cells transduced with the recombinant protein [claim 168, pg. 260].
Regarding claim 2, Tareen teaches the method of claim 1, wherein the stationary phase comprises a selection agent that specifically binds to a selection marker expressed on the surface of the plurality of T cells, wherein specific binding of the selection agent to the selection marker effects the immobilization of the plurality of T cells on the stationary phase [Embodiment 129 – 131, pg. 183 - 184].
Regarding claim 6, Tareen teaches the method of claim 1 further comprising:
Preparing a mixture comprising a T cell stimulatory reagent [Examples 21 – 23, paragraphs [0607 – 0623] and a viral vector preparation, wherein the contacting comprises contacting the plurality of T cells with the mixture [Embodiment 129, pg. 183].
Regarding claim 11, Tareen teaches the method of claim 1, wherein at least a portion of the incubating is carried out at about 37°C, which lies within the range of the claim [paragraphs [0417] and [0612]].
Regarding claim 34, Tareen teaches the method of claim 1, wherein the collecting comprises adding a wash buffer to the column [paragraph [0062]] to collect cells released from immobilization to the stationary phase during incubation.
Regarding claim 51, Tareen teaches the method of claim 1, wherein the T cell stimulatory reagent comprises a first stimulatory agent that specifically binds CD3, and a second stimulatory agent that specifically binds CD28 [paragraphs [0056 – 0059]].
Regarding claim 74, Tareen teaches the method of claim 2, wherein the selection agent [Embodiment 206, pg. 193 – 194] comprises an agent selected from the group consisting of antibodies, antibody fragments, proteinaceous binding molecules with immunoglobulin-like functions, molecules containing Ig domains, cytokines, chemokines, aptamers, MHC molecules, MHC-peptide complexes; receptor ligands; and binding fragments of any of the foregoing.
Regarding claim 76, Tareen teaches the method of claim 2, wherein the selection marker is selected from the group consisting of CD3, CD4, CD8, CD45RA, CD27, CD28, and CCR7 [paragraph [0046]; claims 48 – 50, pg. 242 – 243].
Regarding claim 80, Tareen teaches the method of claim 1, wherein the stationary phase comprises a chromatography matrix [paragraph [0099]].
Regarding claim 84, Tareen teaches the method of claim 1, wherein the T cells comprise CD3+ T cells or comprise CD4+ T cells and/or CD8+ T cells [paragraph [0051]; claims 44 – 49, pg. 242 – 243].
Regarding claim 85, Tareen teaches the method of claim 1, wherein the T cells are primary T cells from a human subject [paragraph [0370]].
Regarding claim 90, Tareen teaches the method of claim 1, wherein the recombinant protein is a chimeric antigen receptor (CAR) [paragraph [0066]].
Regarding claim 97, Tareen teaches the method of claim 1, wherein the viral vector is a retroviral vector [paragraph [0069]].
Regarding claims 111 [claims 181 – 190, pg. 262 – 263] and 119 [claims 186 – 190, pg. 262 – 263], Tareen teaches an article of manufacture and an apparatus that embody the elements and limitations of the two claims, such as:
A composition comprising a first stimulatory agent and a second stimulatory agent capable of specifically binding to first and second molecule on the surface of a T cell to stimulate the T cell
A viral vector.
A stationary phase comprising a selection agent.
An apparatus comprising the article of manufacture.
Conclusion
The invention as claim is anticipated by Tareen. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached Monday - Friday 9:00A - 5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638