DETAILED ACTION
Claims 1-2, 4-7, 11, and 25 are pending.
Election/Restrictions
Applicant’s election of group I, claims 1-2, 4-7, 11, and 25 in the reply filed on 07/08/2026 is acknowledged. Because applicant 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 § 818.01(a)).
Claims 1-2, 4-7, 11, and 25 are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 05/25/2026, 06/28/2023, and 07/08/2026 have been considered by the examiner.
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 1-2, 4, 6-7, 11, and 25 are rejected under 35 U.S.C. 101 because the claimed method is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The judicial exception is not integrated into a practical application and the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Step 1
This part of the eligibility analysis evaluates whether the claim falls within any statutory category per MPEP 2106.03.
Regarding instant claims 1-2, 4, 6-7, 11, and 25, Example 43 of “2019 PEG” is particularly enlightening because the fact pattern of claim 1 of 43 is most similar to the instant application claims 1-2, 4, 6-7, 11, and 25.
Regarding claim 1 of example 43 of the “2019 PEG” and per Step 1, the claim is directed to a process, which is one of the statutory categories of invention as the claim recites “A treatment method comprising: (a) calculating a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder phenotype; (b) administering a treatment to the patient having a non-responder phenotype.” (Step 1: YES).
Similarly, instant claims 1-2, 4, 6-7, 11, and 25 are directed to a statutory method that measures active substances in tumor cells and correlating the measurement with the efficacy of a drug treatment (STEP 1: YES).
Step 2A, Prong 1: Does the claim recite a judicial exception?
This part of the eligibility analysis evaluates whether the claim recites a judicial
exception. As explained in MPEP 2106.04(II) and the October 2019 Update, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim.
Regarding instant claims 1-2, 4, 6-7, 11, and 25, Example 43 of the “2019 PEG” shows a similar fact pattern.
Regarding claim 1 in Example 43 of the “2019 PEG” and per Step 2A, prong 1, the
claim recites the judicial exception of “calculating a ratio of C11 to C13 levels measured in a
blood sample from a patient diagnosed with Nephritic Autoimmune Syndrome Type 3 (NAS-3)
to identify the patient as having a non-responder phenotype,” and according to broadest
reasonable interpretation (BRI), an arithmetic calculation of a division is required to obtain the
ratio of C11 to C13 that can be used to identify whether the patient has the non-respondent
phenotype.
Specifically, limitation (a) in claim 1 of Example 43 of the “2019 PEG” recites “calculating
a ratio of C11 to C13 levels measured in a blood sample from a patient diagnosed with Nephritic
Autoimmune Syndrome Type 3 (NAS-3) to identify the patient as having a non-responder
phenotype,” which has a BRI that requires performing an arithmetic calculation (division) in
order to obtain the ratio of C11 to C13 levels, and then using this ratio to identify whether the
patient has the non-responder phenotype (i.e., the patient has a calculated ratio of 3:1 or
greater and thus is not responding, or will not respond, to glucocorticoids). This limitation
therefore, recites a mathematical calculation. The grouping of “mathematical concepts” in the
2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. 2019 PEG
Section I, 84 Fed. Reg. at 52. Thus, limitation (a) falls into the “mathematical concept” grouping
of abstract ideas. In addition, this type of simple arithmetic calculation (division) can be
practically performed in the human mind, and is in fact performed in the human mind on a daily
basis, for instance by school-aged children studying mathematics. Note that even if most
humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them
complete the recited calculation, the use of such physical aid does not negate the mental nature
of this limitation. Thus, limitation (a) also falls into the “mental process” groupings of abstract ideas.
In addition, limitation (a) describes a naturally occurring relationship between the ratio
of C11 to C13 and the non-responder phenotype, and thus may also be considered to recite a
law of nature. Accordingly, limitation (a) recites a judicial exception (an abstract idea that falls
within the mathematical concept and mental process groupings in the “2019 PEG”, and a law of
nature), and the analysis must therefore proceed to Step 2A Prong Two.
Similarly, instant claims 1-2, 4, 6-7, 11, and 25 recite a method that measures active substances in tumor cells and correlating the measurement with the efficacy of a drug treatment, which describes observing a natural phenomenon, and is thus considered a law of nature. Further, instant claims 1-2, 4, 6-7, 11, and 25 recite “i. 0.01 * Cmax in vivo ≤ Cin vitro ≤ 3 * Cmax in vivo”; and “((0.2 * AUCin vivo) / Cin vitro) ≤ tex ≤ ((3 * AUC in vivo) / Cin vitro))” which recites a mathematical calculation. The grouping of “mathematical concepts” in the 2019 PEG includes “mathematical calculations” as an exemplar of an abstract idea. In addition, this type of arithmetic calculation can be practically performed in the human mind, and is in fact performed in the human mind on a daily basis, for instance by school-aged children studying mathematics. Further, note that even if most humans would use a physical aid (e.g., pen and paper, a slide rule, or a calculator) to help them complete the recited calculation, the use of such physical aid does not negate the mental nature of this limitation.
Further, Instant claim 25 recites a computer-implemented method for selecting in vitro culture parameters for a method that comprises the steps of:
(a) selecting a drug treatment regimen to be evaluate” which is directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). Comparing or looking at collected information, which is an act of evaluating information that can be practically performed in the human mind.
(b) selecting a total in vitro assay time, is directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). Comparing or looking at collected information, which is an act of evaluating information that can be practically performed in the human mind.
(c-g) identifying a sequence and time, identifying the active substances, identifying clinical halftime for each active substance, identifying clinical time for each active substances, and identifying clinical time of presence for each active substance are directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). “Identifying” can be done by merely looking at data and developing an opinion. Comparing or looking at collected information, which is an act of evaluating information that can be practically performed in the human mind.
(h) determining whether there is simultaneous presence of each identified active substance and any of the active substance(s) of the preceding administration(s) and current administration using the following rules:
i. if Ti a in vivo – Txa in vivo ≥ Txpy[y] then the substances are considered not to be present simultaneously in the body;
ii. if Ti a in vivo – Txa in vivo < Txpy[y] than the substances are considered to be present simultaneously in the body is directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). The BRI of (h) is merely looking at the data and comparing it to the following rules and making a judgement based on the comparison. Comparing or looking at collected information, which is an act of evaluating information that can be practically performed in the human mind.
(i-j) identifying an in vivo area under the curve and identifying an in vivo maximal concentration are directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). “Identifying” can be done by merely looking at data and developing an opinion. Comparing or looking at collected information, which is an act of evaluating information that can be practically performed in the human mind.
(k) for each identified active substance, selecting at least one combination of duration Tiex[k][n] of exposure for in vitro assay and in vitro concentration Ciin vitro [k][n] for assay, to satisfy the following rules:
i. 0.01 * Cmax in vivo[k] ≤ Cin vitro[k][n] ≤ 3 * Cmax in vivo[k];
ii. ((0.2 * AUCi in vivo[k]) / Ci in vitro[k][1]) ≤ tiex[k][1] ≤ ((3 * AUC in vivo[k]) / Cin vitro[k][1])) is directed towards an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). The BRI of (k) is merely looking at the data and comparing it to the following rules and making a judgement based on the comparison. Comparing or looking at collected information, which is an act of evaluating information that can be practically performed in the human mind.
Limitations (l) – (o) do not have additional elements that would integrate the judicial exception cited above into a practical application.
Accordingly, instant claims 1-2, 4, 6-7, 11, and 25 recite a judicial exception (a law of nature and an abstract that falls within the mental process grouping) and the analysis must therefore proceed to Step 2A Prong Two.
Step 2A Prong 2: Does the claim recite additional elements that integrate the
exception into a practical application?
Regarding instant claims 1-2, 4, 6-7, 11, and 25, Example 43 of “2019 PEG” shows a similar fact pattern.
In claim 1 of example 43 of the “2019 PEG” and per Step 2A, prong 2, the claim as a whole does not integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claim beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Besides the abstract idea, the claim 1 of example 43 of the “2019 PEG” recites the additional element of “(b) administering a treatment to the patient having a non-responder phenotype”. Although this limitation indicates that a treatment is to be administered, it does not provide any information as to how the patient is to be treated, or what the treatment is, but instead covers any possible treatment that a doctor decides to administer to the patient. In fact, this limitation is recited at such a high level of generality that it does not even require a doctor to take the calculation step’s outcome (the patient’s phenotype) into account when deciding which treatment to administer, making the limitation’s inclusion in this claim at best nominal. Thus, limitation (b) of example 43 of the “2019 PEG” fails to meaningfully limit the claim because it does not require any particular application of the recited calculation, and is at best the equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, limitation (b) of example 43 of the “2019 PEG” does not integrate the recited judicial exception into a practical application and the claim is therefore directed to the judicial exception.
Similarly, instant claims 1-2, 4, 6-7, 11, and 25 do not have additional elements that would integrate the judicial exception cited above into a practical application. In comparison to claim 1, Example 43 did not pass step 2A prong 2 with step of general treatment. Instant claims 1-2, 4, 6-7, and 25 recite the use of a “clinical drug treatment” and instant claim 11 recites the use of “chemotherapy, targeted therapy, immunotherapy or their combination drug treatment regimen”, which amounts to nothing more than identifying a correlation and then “applying a treatment” since the treatment step is recited at a high level of generality. Thus, like claim 1 of example 43, instant claims 1-2, 4, 6-7, 11, and 25 do not pass step 2A prong 2.
Therefore, instant claims 1-2, 4, 6-7, 11, and 25 do not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding instant claims 1-2, 4, 6-7, 11, and 25, this part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. MPEP 2106.05. As explained with respect to Step 2A Prong Two, the claim does not recite any active steps. Instant claim 2 recites “identification of the active substance(s)” which has a BRI of merely evaluating the data and making a judgement or opinion based on the data, which is directed towards the judicial exception as it is an abstract idea that falls under the mental process grouping (i.e., concepts performed in the human mind (including an observation, evaluation, judgement, opinion). Comparing/observing collected information, which is an act of evaluating information that can be practically performed in the human mind. Further, instant claim 11 recites a naturally occurring relationship between tumor cells and their reaction to general drug treatments, and thus is considered to recite a law of nature. Accordingly, instant claims 1-2, 4, 6-7, 11, and 25 are not eligible (STEP 2B: NO).
Thus, instant claims 1-2, 4, 6-7, 11, and 25 are rejected under 35 USC 101.
Allowable Subject Matter
Claim 5 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ooft et al., Patient-derived organoids can predict response to chemotherapy in metastatic colorectal cancer patients. Sci Transl Med. 2019 Oct 9;11(513):eaay2574. doi: 10.1126/scitranslmed.aay2574. PMID: 31597751 (IDS filed on 06/28/2023).
Ooft teaches evaluating a clinical drug treatment, noting the sequence and timing of drug administration in the drug regimen and identifying the one or more active substances relevant for each noted administration; selecting in vitro culture parameters comprising concentrations for incubation, duration of exposure for incubation, and selecting time points; selecting in vitro culture parameters corresponding to each noted drug administration; providing a culture of tumor cells for an in vitro assay; culturing the tumor cells in vitro with addition of each identified active substance(s) at the selected time point(s) of addition in accordance with the sequence and incubating in the presence of the selected concentration(s) of said active substance(s) for the selected duration(s); determining the phenotypical changes of the tumor cells due to effect of the active substance(s); and evaluating the efficacy of the drug treatment regimen based on the observed phenotypical changes.
Ooft does not teach or suggest the use of the equation ((0.2 * AUCin vivo) / Cin vitro) ≤ tex ≤ ((3 * AUC in vivo) / Cin vitro)).
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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