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 .
Claim Status
To expedite the compact prosecution, the Examiner is pursuing the amended claims dated 20 September 2024, in which applicant canceled claims 1-12; and added claims 13-27.
Therefore, claims 13-27 are pending in the application.
Priority
This application was filed 04/15/2024 and is a 371 application of PCT/EP2022/078470 filed on 10/13/2022, which claims benefit to the foreign application EP21202832.8 filed on 10/15/2021 and a certified translated copy filed 04/15/2024 is acknowledged.
Thus, the earliest possible priority for the instant application is 10/15/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/06/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, and the signed and initial PTO Forms 1449 are mailed with this action.
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.
Claims 13-23 and 26-27 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rezvani et al., (WO2021108671A1; cited in IDS filed 08/06/2024; hereinafter “Rezvani”).
Regarding claims 13, 15-18, 26, Rezvani discloses a method of producing engineered NK cells, wherein one of the options is that the method comprises expanding the NK cells with APC and IL-2, electroporating the expanded NK cells with Cas9 and one or more guide RNAs, thereby producing gene edited NK cells; and then transducing the gene edited NK cells with one or more lentiviral vectors each encoding one or more heterologous antigen receptors to produce gene edited modified NK cells; finally expanding the NK cells ([0061]-[0065] and claims 1-5), The obtained population of genetically modified NK cells are tested for their anti-tumor activity [0055], [00217].
Regarding claims 14 and 19, Rezvani envisages both options, i.e. wherein the electroporation follows or precedes the transduction step, and the time windows recited in [0063] and [0064] fall into the scope of instant claim, directed to specific time windows between the electroporation and the transduction.
Regarding claims 20-23, Rezvani teaches that the NK cells are genetically engineered to express one or more heterologous antigen receptors, such as one or more engineered TCRs, one or more CARs, one or more chimeric cytokine receptors, ([0076], claim 24), wherein the heterologous antigen receptor targets an antigen selected from the group consisting of CD33. Therefore, antigen that is normally expressed by NK cells is (CD33 [0019], [0087], [00107], claim 26).
Regarding claim 27, Rezvani FACS plot of Fig. 10B teaches that the population of genetically engineered NK cells express at least 10% more CD16, compared with a reference population of genetically engineered NK cells obtained by introducing the genetic modifier 2 into the NK cells before introducing the genetic modifier l into the NK cells [0035], [057], [0068], [00219].
Accordingly, Rezvani anticipates the instant claims 13-23 and 26-27.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13-23, 24-25 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Rezvani et al., (WO2021108671A1; cited in IDS filed 08/06/2024; hereinafter “Rezvani”), in view of Abujoub et al. (US20210220404A1; Pub. Date: Jul. 22, 2021; cited in PTO892; hereinafter “Abujoub”).
As discussed previously, Rezvani discloses a method of producing engineered NK cells, wherein one of the options is that the method comprises expanding the NK cells with APC and IL-2, electroporating the expanded NK cells with Cas9 and one or more guide RNAs, thereby producing gene edited NK cells; and then transducing the gene edited NK cells with one or more lentiviral vectors each encoding one or more heterologous antigen receptors to produce gene edited modified NK cells; finally expanding the NK cells ([0061]-[0065] and claims 1-5), The obtained population of genetically modified NK cells are tested for their anti-tumor activity [0055], [00217].
Although regarding claim 24, Rezvani teach the expanded NK cells produced from the process comprise a clinically relevant dose [0075] encompassed a pharmaceutically acceptable carrier [00180]. Although Rezvani does not specifically teach the method is performed in a closed system. However, such was known in the prior art.
Regarding claims 24-25, Abujoub teachs immune effector cells (for example, T cells, NK cells) that express a chimeric antigen receptor (CAR), and compositions manufacturing process, including cell separation, activation, transduction, incubation, and purification may be performed in a closed and automated system (abstract, [0166], [0617]-[0619], [0622]-[0624] of Abujoub).
MPEP 2143 (A) states that combining prior art elements according to known methods to yield predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Accordingly, it would have been obvious to a person of ordinary skill in the art at the time of filling to performed the genetically modified immune-cell of Rezvani in a closed and including the automated manufacturing system as taught by Abujoub, in order to provide a controlled cell manufacturing process and reduce open handling of the cellular product to reduce risk of contamination ([0839] of Abujoub) with a reasonable expectation of successfully producing the genetically modified cells.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is 571-272-0196. The examiner can normally be reached M-F 8-5 (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic, can be reached on (571) 272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684
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