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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/5/2026 has been entered.
Response to Amendment
The amendment filed June 5, 2026 has been entered.
Claims 32-43 remain pending in the application. Claims 1-31 are canceled.
Based on Applicant’s amendments and remarks, the previous 101 rejection has been modified to address the claim amendments.
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.
Claims 32-43 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 32, 4th to Last Ln.-Last Ln. recite, “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 indicates that the effector cell is functional”. However, this limitation appears to indicate that regardless of the measured value of any of these values, that the effector cell will be indicated as functional. Are there any scenarios where the effector cell will not be considered functional based on the measured value? Further clarification is needed. For purposes of compact prosecution, the above limitation has been examined as, “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 indicates whether the effector cell is functional”.
Claims 33-43 are rejected as depending on a rejected claim.
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 on 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 indicates that the effector cell is functional”. 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 functional, 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; already of record) 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 June 5, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 6-7 of their Remarks that the recited limitation “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 indicates that the effector cell is functional” is unconventional at the effective filing date of the invention. While the Examiner agrees that the recited claim is free of the prior art, the claim as a whole, included the recited limitation above, is drawn to an abstract idea, and is patent eligible as rejected under 35 U.S.C. 101. Further, the above limitation is not a positively recited method step, and merely describes what the previously recited measuring step is indicative of, and even if it were considered to be positively recited, it would be an evaluation/determination-type mental process to determine whether the measured property correlates to an effector cell being functional, and is therefore an abstract idea.
Applicant further argues on Pg. 7 of their Remarks that the claimed methods reflect the improvements identified in the instant Specification, and that the answer two Step 2A Prong Two should be yes, making the claims subject matter eligible. However, it is unclear precisely which improvements in the Specification the Applicant is referring to, and further it is unclear whether the claims reflect this improvement. Further evidence is needed to determine whether any improvements reflected in the claim render the claims subject matter eligible.
Applicant further argues on Pg. 8 of their Remarks that the claimed subject matter amounts to significantly more than the alleged judicial exception, because the claims include the positively recited step “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 indicates that the effector cell is functional”. However, as previously addressed, this is not a positively recited method step, and even if it were considered to be positively recited, it would itself be an abstract idea-type judicial exception. Fore a more detailed explanation, please see the Claim Rejections-35 USC 101 section of this instant Office Action.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
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/JOHN MCGUIRK/Examiner, Art Unit 1798
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