DETAILED ACTION
Claim 39 is pending.
Claim Rejections - 35 USC § 101-Maintained.
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
Claim 39 is 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 claim 39, 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 claim 39.
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 claim 39 is directed to a statutory method that measures naturally
occurring proteins and correlating the levels of the naturally occurring proteins with liver cancer
(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 claim 39, 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 claim 39 recites a method for detecting or quantifying free apoptosis
inhibitor of macrophage (AIM) in a biological sample and correlating the measurement of free
AIM with liver cancer, which describes a naturally occurring relationship between the protein
biomarkers and a disease, and thus is considered a law of nature.
Accordingly, instant claim 39 recites 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 claim 39, 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 claim 39 does 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 claim 39 doesn’t even recite a general treatment. Example 43 failed with a general, instant claim 39 doesn’t recite a
further active step, let alone a treatment.
Therefore, instant claim 39 does not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
Regarding instant claim 39, 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 39 recites “contacting the biological sample with an anti-AIM antibody
under non-reducing or non-denaturing conditions and performing an immunoassay that detects
the free AIM while the complex of the AIM and binding partner remains undissociated, and
determining the amount of free AIM based on the immunoassay signal”. However, changing the
conditions of the immunoassay does not change that the claim recites a naturally occurring
correlation. Further, preparing the biological sample which comprises the free AIM, the complex
AIM, and a complex of AIM and a binding partner, without exposing the biological sample to a
protein denaturing condition or to a reductive condition such that the complex of AIM and the
binding partner is not decomposed in the biological sample; and contacting the biologicals
sample with an anti-AIM antibody under non-reducing or non-denaturing conditions does not
amount to significantly more. The instant application teaches that a sample buffer that does not
comprise SDS and mercaptoethanol is considered a non-reductive condition (see [0091]). Non-
reducing and non-denaturing conditions have been used in the art before the instant
applications earliest filing date.
Morrison et al., (2001). Affinity purification and partial characterisation of systemic
immunoglobulin of the snapper (Pagrus auratus). University of Tasmania. Journal contribution.
https://hdl.handle.net/102.100.100/596152 teaches the use of non-reducing or non-denaturing
conditions (see abstract, see page 2, see page 4) was a technique that was known and used
in the art at the time of the instant application.
Accordingly, instant claim 39 is not eligible (STEP 2B: NO).
Thus, instant claim 39 is rejected under 35 USC 101.
Claim Rejections - 35 USC § 101-Response to Arguments
The arguments filed on 07/28/2026 have been fully considered but they are not persuasive.
On p. 3-4 and 6-7 applicant argues that Morrison, which is cited in the 35 USC 101, does not teach detection of free AIM.
However, Morrison teaches that contacting a biological sample under non-reducing or non-denaturing conditions then performing an immunoassay was known and used in the art at the time of the instant application. Changing the conditions of the immunoassay does not change the natural correlation. Morrison explicitly teaches that contacting a biological sample under non-reducing or non-denaturing conditions was known at the time of the instant application.
On p. 4 applicant argues that the instant application is eligible under step 2A, prong one because it is not merely directed to a natural relationship between free AIM and liver cancer, as it focuses on sample-preparation and selective-detection protocols.
However, the instant claims are still directed to a natural product. The preparation step only changes the conditions of the assay, not the natural product itself. Further, the claims are still directed to measuring a natural product and then correlating that measurement to a subject having liver cancer, which is a natural correlation.
On p. 5 applicant argues that the instant application is eligible under step 2A, prong 2 because example 2 demonstrates the technical importance of the claimed protocol. Applicant further argues that the recited conditions produce a meaningful technical effect. However, the recited conditions (contacting the biological sample under non-reducing or non-denaturing conditions) was a technique used in the art at the time of the instant application. The preparation step only changes the conditions of the assay, not the natural product or the natural correlation itself.
On p. 5 applicants argue that the instant claim is a laboratory process for preparing and analyzing a biological sample and does not merely instruct a practitioner to observe or apply a natural relationship, but how a sample should be physically handled and how the immunoassay should be conducted to obtain the claimed selective measurement.
However, the instant claim recites “a method for detecting or quantifying free apoptosis inhibitor of macrophage (AIM) in a biological sample derived from a test subject for examining liver cancer”. Thus, the measurement of free AIM is directly correlated to liver cancer, resulting in a natural correlation.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/MCKENZIE A DUNN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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