DETAILED ACTION
Claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, and 54-60 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/02/2026 has been entered.
Status of Claims
Claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, and 54-60 are pending. Claims 1, 11, 21, 24, and 41 have been amended. Claims 54-60 have been newly added.
Claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, and 54-60 are under examination.
Claim Rejections - 35 USC § 101 New-Necessitated by Amendments.
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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58, 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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58.
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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 are directed to a statutory method that measures naturally occurring proteins and correlates the levels of the naturally occurring proteins with an unruptured brain aneurysm (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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58, 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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 recites measuring protein analyte expressions and correlating the measurements to the detection of an unruptured brain aneurysm, which describes a naturally occurring relationship between the protein biomarkers and a disease, and thus is considered a law of nature. Further, claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 recite “determining, using the protein analyte expression measures for each signature protein analyte in the set of signature protein analytes, a presence of an unruptured intracranial aneurysm in the test subject”, which is directed toward 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 collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind. Consequently, claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 recite the judicial exception of applying and using a law of nature and an abstract idea.
Dependent instant claim 11 contains limitations that fall under the judicial exception. Instant claim 11 recites “determining the presence of the unruptured intracranial aneurysm comprises a probability that the subject has an intracranial aneurysm and a prediction of the size of the intracranial aneurysm”. The language “determining” and “predict” are directed to a 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 collected information to a predetermined threshold is an act of evaluating information that can be practically performed in the human mind. Further, instant claim 11 describes a naturally occurring relationship between nature-based products and correlating it to the probability that a subject has an unruptured intracranial aneurysm, and thus is considered to recite a law of nature.
Accordingly, instant claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 recite a judicial exception (a law of nature and an abstract idea 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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58, 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, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 do not have additional elements that would integrate the judicial exception cited above into a practical application. In comparison to claim 43, Example 43 did not pass step 2A prong 2 with step of general treatment. Instant claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 recite “performing angiographic imaging of the cerebral vasculature to confirm and localize the aneurysm”. 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 performing angiographic imaging merely to confirm and localize the aneurysm also fails to add significantly more and is equivalent to apply a confirmation. Accordingly, the limitation “performing angiographic imaging…” does not integrate the recited judicial exception into a practical application and the claim is therefore directed to a judicial exception. Further, instant claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 do not even recite a general treatment. Example 43 failed with a step of a general treatment, instant claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 do not recite a further active step, let alone a step for treatment.
Therefore, instant claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 do not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding instant claims 1-2, 5-6, 11-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 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. While instant claim 1 recites “performing angiographic imaging”, the imaging is not applying the judicial exception into a practical application, the imaging step is just confirming the results of the judicial exception. Thus, claims 1-2, 5-6, 12-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 do not recite any active steps. Instant claim 11 recites “predicting” however, that language is still directed to a 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 collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind. Further, claim 11 recites a naturally occurring relationship between a nature-based product and correlating it to the probability that a subject has an unruptured intracranial aneurysm, and thus is considered a law of nature. Accordingly, instant claims 1-2, 5-6, 12-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 are not eligible (STEP 2B: NO).
Thus, instant claims 1-2, 5-6, 12-13, 15, 19, 21, 24, 27-28, 32, 34, 41, 54, and 58 are rejected under 35 USC 101.
Claim Rejections - 35 USC § 101-Response to Arguments
The arguments filed on 03/02/2026 have been considered by the examiner.
On pp. 12-13 applicant argues that measuring CXCL6, VASP-8, CD40, CXCL5, CXCL1, ST1A1, EN-RAFE, and Flt3L is incorrectly characterized as a product of nature judicial exception. Applicant argues that the instant application does not recite products of nature, but a method or process that includes obtaining measurements of expression for protein analytes, and the instant claims do not implicate the preemption considerations underlying the products of nature category described in Myraid and Ambry Genetics, because the claims do not seek to tie up the use of any naturally occurring things.
However, the instant application does recite a natural correlation. The instant application recites measuring CXCL6, VASP-8, CD40, CXCL5, CXCL1, ST1A1, EN-RAFE, and Flt3L (naturally occurring proteins) and correlating those naturally occurring proteins to an unruptured intracranial aneurysm. The instant application recites a natural correlation which is a judicial exception.
On pp. 13-14 applicant argues that the instant application integrates the judicial exception into a practical application, such as technical improvements. Applicant argues that claim 1 clearly provides an improvement to the technical field by (i) using a set of signature protein analytes to predict the presence of an unruptured IA in a subject and (ii) integrating the detection into a concrete diagnostic workflow that includes confirmatory and localizing angiographic imaging.
However, the use of angiographic imaging does not integrate the judicial exception into a practical application because the angiographic imaging is confirming the results of the biomarker measurements. Performing angiographic imaging does take the naturally occurring proteins and integrate them into a practical application.
On p. 15 applicant argues that like Cardionet, LLC v. Infobionic, Inc, the instant application does not stop at detection of correlation, but instead integrate that detection into a specifical technological process. However, Cardionet did not include an interventive concept sufficient to transform the claims into patent-eligible applications.
On pp. 16-17 applicant argues that claim 27 integrates the judicial exception into a practical application. Applicant argues the use of a classifier integrates the judicial exception into a practical application. However, the use of a classifier does not integrate the judicial exception into a practical application because a classifier makes a series of data evaluations and makes a judgement based on those evaluations.
Allowable Subject Matter
Claims 55-57 and 59 are 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.
Claims 55-57 and 59 are allowable because it is not found or suggested in the prior art measuring CXCL6, VASP-8, CD40, CXCL5, CXCL1, ST1A1, EN-RAFE, and Flt3L to diagnose an unruptured intracranial aneurysm.
The closest prior art of record is Vlachogiannis et al., “Temporal patterns of inflammatory biomarkers measured in the cerebrospinal fluid of patients with aneurysmal subarachnoid hemorrhage using multiplex Proximity Extension Assay technology” (2020).
Vlachogiannis teaches measuring CXCL6, CASP-8, CD40, CXCL5, CXCL1, ST1A1, EN-RAGE, and Flt3L in a panel for detection of neuroinflammation.
Vlachogiannis teaches measuring these biomarkers in a panel for ruptured intracranial aneurysms. Vlachogiannis does not teach or suggest measuring these biomarkers in an unruptured intracranial aneurysm.
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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