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 .
Response to Amendment
The amendment filed January 9, 2026 has been entered.
Claims 32-43 are newly added and are pending and examined in the application. Claims 1-31 are canceled.
Applicant’s amendments to the Claims have overcome each and every objection, 112(b) rejection, 101 rejection, 102 rejection, and 103 rejection previously set forth in the Non-Final Office Action mailed August 11, 2025. However, new 101 rejections have been made on the new claims, as shown below in the Claim Rejections-35 USC 101 section of the instant Office Action. Applicant’s amendments necessitated the new grounds of rejection.
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.
Claims 32-43 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The subject matter eligibility test for the claims is shown below:
Subject Matter Eligibility Test, Step 1
Independent claim 32 is drawn to a method, which is a statutory category.
Subject Matter Eligibility Test, Step 2A Prong One
In Step 2A Prong One, it is determined if the claims recite an abstract idea, law of nature, or natural phenomenon. Independent claim 32 recites a method comprising “selecting at least one subset of microwells comprising at least one effector cell and at least one tumor cell at time t0”, “subdividing the microwells of the at least one subset of microwells based one the number of effector cells per well…and by the number of tumor cells per well…to thereby select at least one second subset of microwells having a determined number of the effector cells per well at time t0 and a determined number of the tumor cells per well at time t0”, and “measuring tumor cell mortality, cell viability, cell apoptosis, and/or cell proliferation in the at least one second subset of microwells at a later time t1”. The acts of selecting a first subset of microwells based on having at least one effector cell and at least one tumor cell, and further subdividing the selected first subset based on the number of effector cells and number of tumor cells in each well to obtain a second subset of microwells, are evaluation/determination-type mental processes which can be performed in the human mind. Further, the act of measuring mortality, viability, apoptosis, and/or cell proliferation in the second subset of microwells is a mathematical calculation-type abstract idea that can also be performed in the human mind. Additionally, independent claim 32 recites, “wherein the measured tumor cell mortality, cell viability, cell apoptosis, and/or cell proliferation in the at least one second subset of microwells at a later time t1 is indicative of the efficacy of said effector cell as an immunotherapy agent”. However, this is not a positively recited method step, and merely describes what the previously recited measuring step is indicative of. Further, even if this wherein clause were to be considered a positively recited method step, it would be an evaluation/determination-type mental process to determine whether the measured property correlates to an effector cell being an effective immunotherapy agent, and is therefore an abstract idea. Independent claim 32 therefore recites an abstract idea.
Subject Matter Eligibility Test, Step 2A Prong Two
In step 2A Prong Two, it is determined if the claims recite additional elements that integrate the judicial exception into a practical application. Independent claim 32 further recites: “providing a substrate comprising a plurality of microwells”, and “seeding the plurality of microwells with a mixture of cells comprising immune effector cells and tumor cells”. These limitations are pre-solution activity, and are necessary to be able to perform the acts of selecting a first subset of microwells based on having at least one effector cell and at least one tumor cell, subdividing the first subset into a second subset of microwells based on the number of effector cells per well and the number of tumor cells per well, and measuring cell properties of the second subset of microwells, which have been established as an abstract idea in Step 2A Prong One. Therefore, these additional limitations would not be considered a practical application. Accordingly, the additional elements recited do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Subject Matter Eligibility Test, Step 2B
In step 2B, it is determined if the claim recites additional elements that amount to significantly more than the judicial exception. In this case, independent claim 32 additionally recites “a substrate comprising a plurality of microwells”, and “a mixture of cells comprising immune effector cells and tumor cells”. These elements are well-known and conventional within the art. Further, the application of these mental processes into a method for detecting immunotherapy efficacy is nothing more than generally linking the abstract idea judicial exception to a particular technological environment or field of use. See MPEP 2106.05(d) and 2106.05(e). Still further, the acts of “providing a substrate comprising a plurality of microwells”, and “seeding the plurality of microwells with a mixture of cells comprising immune effector cells and tumor cells” are insignificant pre-solution activity, and are necessary to be able to perform the acts of selecting a first subset of microwells based on having at least one effector cell and at least one tumor cell, subdividing the first subset into a second subset of microwells based on the number of effector cells per well and the number of tumor cells per well, and measuring cell properties of the second subset of microwells. See MPEP 2106.05(f).
Further, with regards to the generically recited substrate comprising a plurality of microwells and mixture of cells comprising immune effector cells and tumor cells being nothing more than well-understood, routine, and conventional components that are well-known in the art, the following prior art is relied upon to show that the above elements are well-understood, routine, and conventional:
Bocchi et al. (US Pub. No. 2013/0252258; hereinafter Bocchi ‘258) teaches a substrate comprising a plurality of microwells ([0088]). A mixture of cells comprising immune effector cells and tumor cells ([0088], [0114]-[0116]).
Bocchi et al. (WO Pub. No. 2017/216739; hereinafter Bocchi ‘739; already of record) teaches a substrate comprising a plurality of microwells ([0078]-[0079], see Fig. 1 at substrate having open microwells 2, see also Claim 9).
Claims 33-43 are rejected under 35 U.S.C. 101 as depending on a rejected claim.
Response to Arguments
Applicant's arguments filed January 9, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 5-7 of their Remarks that the newly added claims in the claim set filed 1/9/2026 perform manipulations and operations using a physical entity, and therefore the claims are not directed to an abstract idea, and even if the claims do include an abstract idea, the abstract idea is integrated into a practical application, i.e. the detection of immunotherapy efficacy. The Examiner respectfully disagrees. The fact that the claims perform manipulations and operations using a physical entity do not preclude the claims from reciting an abstract idea. In fact, the claims still recite an abstract idea, and the recited abstract idea is not sufficiently integrated into a practical application to render the claimed subject matter patent eligible. For a more detailed explanation, please see the Claim Rejections-35 USC 101 section of this instant Office Action.
Applicant further argues on Pgs. 7-11 of their Remarks that the newly added claims overcome the prior art of record. While the Examiner agrees that the newly added claims do overcome the prior art of record, the claims are still rejected under 35 USC 101, and are not in condition for allowance.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JOHN MCGUIRK/Examiner, Art Unit 1798