DETAILED ACTION
Claims 1-2, 7, and 15-24 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/20/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 04/20/2026 has been considered by the examiner.
Status of Claims
Claims 1-2, 7, and 15-24 are pending. Claims 1-2 have been amended. Claims 1-2, 7, and 15-24 are under examination.
Withdrawn Claim Objections and/or Rejections
The arguments filed on 04/20/2026 have been considered by the examiner.
The rejection of claims 1-7 and 4-14 under 35 USC 112(a) for failing to comply with written description as set forth on pp. 3-8 of the previous office action (mailed on 12/19/2025) has been withdrawn in view of the amended claims (filed on 04/20/2026).
The rejection of claims 1-7, 147, and 17-19 under 35 USC 103 as being unpatentable over Ebrahimi and Albright et al., as set forth on pp. 15-23 of the previous office action (mailed on 12/19/2025) has been withdrawn in view of the amended claims (filed on 04/20/2026).
The rejection of claims 15-16 under 35 USC 103 as being unpatentable over Ebrahimi, Albright, and Trumpie et al., as set forth on pp. 23-25 of the previous office action (mailed on 12/19/2025) has been withdrawn in view of the amended claims (filed on 04/20/2026).
The rejection of claims 1-7, 14, and 16-19 for double patenting over copending application 17802500 as set forth on pp. 25-28 of the previous office action (mailed on 12/19/2025) has been withdrawn in view of copending application 17802500 being abandoned.
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, 7, and 15-24 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, 7, and 15-24, Example 43 of “2019 PEG” is particularly enlightening because the fact pattern of claim 1 of example 43 is most similar to the instant application claims 1-2, 7, and 15-24.
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, 7, and 15-24 are directed to a statutory method that measures naturally occurring nucleoproteins and correlates the levels of the naturally occurring nucleoproteins to the presence and progression of an infection (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, 7, and 15-24, 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, 7, and 15-24 recites measuring nucleoproteins and correlates the levels of the nucleoproteins to the presence and progression of an infection, which describes a naturally occurring relationship between a nucleoprotein biomarker (cell free nucleosomes comprising histone H3.1) and a disease, and thus is considered a law of nature. Consequently, instant claims 1-2, 7, and 15-24 recite the judicial exception of applying and using a law of nature.
Accordingly, instant claims 1-2, 7, and 15-24 recite a judicial exception (a law of nature) 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, 7, and 15-24, 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, 7, and 15-24 do not have additional elements that would integrate the judicial exception cited above into a practical application. Instant claim 2 recites “wherein a subject identified with a high likelihood of an adverse outcome is assigned for medical intervention”. Like example 43 where the general treatment was found lacking any
significance and at best was equivalent to adding the words “apply it” to the judicial exception,
the instant claim of assigning a subject for medical intervention also fails to add significantly more and is equivalent to just “applying” a treatment. In comparison to claim 43, Example 43 did not pass step 2A prong 2 with step of general treatment, instant claims 1-2, 7, and 15-24 do not recite any additional elements other than the law of nature and the abstract idea. Example 43 failed with the step of a general treatment, instant claims 1-2, 7, and 15-24 do not even recite a further active step, let alone a step for treatment.
Therefore, instant claims 1-2, 7, and 15-24 do not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding instant claims 1-2, 7, and 15-24, 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
claims do not recite any active steps. While instant claim 2 recites “wherein a subject identified with a high likelihood of an adverse outcome is assigned for medical intervention”, does not add significantly more and is equivalent to just “applying” a treatment. Accordingly, instant claims 1-2, 7, and 15-24 are not eligible (Step 2B: NO).
Thus, instant claims 1-2, 7, and 15-24 are rejected under 35 USC 101.
Response to Arguments
The arguments filed on 04/20/2026 have been considered by the examiner.
On pp. 8-9 applicant argues that detecting H3.1-nucleosome levels using serial sampling to monitor the progress of an infection has not been previously disclosed or suggested in the art and thus, provides a practical application with significantly more than the judicial exception.
However, while detecting H3.1-nucleosome levels using serial sampling to monitor the progress of an infection has not been disclosed or suggested in the art, the instant claims are still directed to a judicial exception without significantly more. Regardless of the art, the claims are directed to statutory method that measures naturally occurring nucleoproteins and correlates the levels of the naturally occurring nucleoproteins to the presence and progression of an infection. The instant claims recite applying and using the judicial exception (a law of nature).
On p. 9 applicant argues that the amendments to the claims to recite using a two-site immunoassay employing an anti-nucleosome binding agent in combination with an anti-histone H3.1 antibody is not an insignificant extra-solution activity.
However, using a two-site immunoassay employing an anti-nucleosome binding agent in combination with an anti-histone H3.1 antibody is an insignificant extra-solution activity because it is merely confirming the judicial exception. Performing a two-site immunoassay does not take the naturally occurring nucleoproteins and integrate them into a practical application.
On p. 9 applicant argues that results presented in the application filed provide evidence that the level of cell free nucleosomes comprising histone H3.1 provides a distinct result over methods of detecting the total level of cell free nucleosomes. While the benefits are understood by the examiner, the instant claims still recite the judicial exception of a law of nature as it correlates naturally occurring nucleoproteins to a disease (sepsis or septic shock).
Conclusion
No claim is allowed.
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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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