DETAILED ACTION
Status of Application, Amendments and/or Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are pending.
Election/Restrictions
Applicants’ election of Group I, claims 1-11, in the reply filed on 1/14/26 is acknowledged. There is no indication of whether the election is with or without traverse, but because the response did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
The following elections of species made in the reply are also acknowledged:
(1) CD22 as the species of first antigen;
(2) T-cell as the species of immune cell;
(3) cytokine secretion as the species of cellular activity; and
(4) cell culture plate as the species of support;
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-4 and 6-11 are under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claims 10 and 11 are objected to because of the following informalities:
In claim 10, line 3, “that has been…” should be “which has been…”
In claim 11, line 2, “wherein the activity which level is determined” should be “wherein the activity level which is determined”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-4 and 6-11 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 pre-AIA the applicant regards as the invention.
In claim 1, there is no conjunction joining steps (i)-(iii); as such it is unclear whether this should be “and” or “or”, and thus whether the method requires that all of the steps are performed, only requires that one of the steps is performed.
In claim 2, the phrase "disease states like a cancer or viral infection" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by disease states that are “like” the specified examples), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d). Specifically, it is unclear whether the disease state is limited to cancer or viral infection, or encompasses other unspecified disease states that are in some way “like” the specified disease states.
The remaining claim(s) included in the rejection are dependent claims that depend from one of the claims rejected above, and encompass the same indefinite subject matter.
Note on Prior Art Rejection(s)
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.
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 1-4 and 6-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bedoya et al, U.S. Patent Application Publication 2017137783, published 5/18/17 (cited on the 12/16/22 IDS). The earliest date to which the instant application claims priority is 7/3/20.
In claim 1, the recitation in the preamble that the method is for “characterizing the potency of an immune cell expressing a chimeric antigen receptor (CAR)” has been considered in the context of the entire claim, and is interpreted as an intended use for the method because it does not result in a manipulative difference between the method as defined by the steps and a prior art method teaching the same steps. See MPEP 2111.02. As such, this intended use does not distinguish the claimed method from a prior art method comprising the same step(s). Thus, claim 1 encompasses an in vitro method comprising the steps of (1) providing an immune cell expressing a CAR targeting an antigen; (2) stimulating said cell by incubating it on a ligand-coated support that is not a cell or a bead, wherein the ligand comprises the antigen targeted by the CAR, and (3) determining the level of activity of the stimulated cell.
Bedoya teaches methods for “activation of immune cells by transiently expressing a Chimeric Antigen Receptor (CAR) molecule”, which “can be activated via ligand of the CAR molecule, e.g., a ligand of the CAR antigen binding domain (e.g., a cognate antigen molecule” (¶ 6). Bedoya further teaches that “[i]n embodiments, the ligand of the CAR molecule is present in/on (e.g., immobilized or attached to) a substrate, e.g., a non-naturally occurring substrate (¶ 7), and further where the substrate is “a solid support” chose from a group including a plate (¶ 23). Bedoya further teaches that “[p]otency of the immune effector cells can be defined”, for example, “by various T cell functions”, for example, “cytokine production”, which “show at least a one, two, three, four, five, ten fold or more increase in pg/ml of proinflammatory cytokine production” (¶ 64). Thus, Bedoya teaches a method comprising (i) providing an immune cell expressing a CAR targeting an antigen; (i) stimulating (e.g., activating as taught by Bedoya) the cell by incubating the cell on a ligand-coated support that is not a cell or bead (e.g. a plate as taught by Bedoya), wherein the ligand is that of the CAR; and (3) determining the level of activity of the stimulated immune cell (e.g., an increase in the level of cytokine production as taught by Bedoya). As such, the teachings of Bedoya anticipate claim 1.
Claims 2-4 each encompass the method of claim 1 wherein the CAR comprises an extracellular antigen-binding domain (ABD) binding specifically to a target antigen associated with cancer (claim 2), wherein the antigen is a tumor antigen (claim 3) or wherein the antigen is CD22 (claim 4), which is a tumor antigen. Bedoya further teaches that CAR can be an anti-CD22 CAR (¶ 34). As such, the teachings of Bedoya also anticipate claims 2-4.
Claim 6 encompasses a method of claim 1 wherein the cell expresses two or more CARs binding specifically to different target antigens associated with cancer. Bedoya further teaches that the cells can comprising a first and second CAR (e.g., ¶ 68-69) and further where each “targets a different cancer associated antigen” (¶ 83). As such, the teachings of Bedoya also anticipate claim 6.
Claim 7 encompasses a method of claim 6 wherein steps (i) to (iii) are performed with one ligand-coated support comprising a polypeptide comprising any one of the antigens targeted by said CARs. Such is met by the same teachings that meet the limitations of claims 1-4 and 6, where the one target antigen is CD22 as taught by Bedoya. As such, the teachings of Bedoya also anticipate claim 7.
Claims 8 and 9 encompass a method of claim 1 wherein the cell is a T-cell. Bedoya further teaches that the cells are T-cells (e.g., see Abstract, ¶ 13). As such, the teachings of Bedoya also anticipate claims 8 and 9.
Claim 10 encompasses a method of claim 1 wherein said immune cell of step (i) is an immune cell obtained from a patient that has been engineered ex vivo to express said CAR. Bedoya further teaches that the methods of the invention can be performed ex vivo (¶ 11). Bedoya also further teaches that the cells which are acquired and in which the CAR will be transiently expressed are “autologous to the subject who the cells will be administered to” (¶ 51), which indicates the method is performed ex vivo. As such, the teachings of Bedoya also anticipate claim 10.
Claim 11 encompasses a method of claim 1 wherein the activity level that is determined in step (iii) is cytokine secretion. As set forth above for claim, Bedoya teaches defining the potency of cytokine production, which is encompassed by determining the level of cytokine secretion. As such, the teachings of Bedoya also anticipate claim 11.
Conclusion
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY C HOWARD whose telephone number is (571)272-2877. The examiner can normally be reached on Monday to Friday from 9 AM to 5 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford, can be reached at telephone number (571) 272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY C HOWARD/Primary Examiner, Art Unit 1674