DETAILED ACTION
Claims 1-20 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 06/06/2024 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 1-14 and 16-20 are rejected under 35 U.S.C. 101 because the claimed product and method are 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 1-12, and 14-20, 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 1-12, and 14-20.
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 1-12, and 14-20 are directed to a statutory method of measuring naturally occurring proteins and correlating the measurements with the effectiveness of a treatment with lanifibranor in a patient with liver disease (STEP 1: YES).
B. In the instant application, claim 13 recites a combination of biomarkers consisting of adiponectin, ferritin, MMP9, and transferrin, which are proteins. Because proteins are composed of matter, adiponectin, ferritin, MMP9, and transferrin biomarkers are a composition of matter, which is a statutory category of invention. As explained in the MPEP, it is not necessary to identify single category into which a claim falls, so long as it is clear that the claim falls into at least one category. MPEP 2106.03(I). Here, because the adiponectin, ferritin, MMP9, and transferrin biomarkers are a composition of matter, the claim is to at least one category of invention (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.
A. Regarding instant claims 1-12 and 14-20, 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 1 recites measuring naturally occurring biomarkers adiponectin, ferritin, MMP9, and transferrin, and correlating the measurement to the effectiveness of a treatment with lanifibranor which is considered a law of nature. Further instant claim 1 recites “b) assessing the effectiveness of the treatment with lanifibranor…”, 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, instant claim 1 recites the judicial exception of applying and using a law of nature and an abstract idea.
Instant claim 12 recites a system for measuring naturally occurring biomarkers adiponectin, ferritin, MMP9, and transferrin, and correlating the measurement to the effectiveness of a treatment with lanifibranor which is considered a law of nature. Further, instant claim 12 recites “a) a means for measuring or receiving measurement data of levels of a combination of biomarkers consisting of adiponectin, ferritin, MMP9 and transferrin in a biological sample from the patient” 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, instant claim 12 recites the judicial exception of applying and using a law of nature and an abstract idea.
Instant claim 15 recites measuring naturally occurring biomarkers adiponectin, ferritin, MMP9, and transferrin, and correlating the measurement to the effectiveness of a treatment with lanifibranor which is considered a law of nature. Further, instant claim 15 recites “assessing” and “predicting” which are 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, instant claim 15 recites the judicial exception of applying and using a law of nature and an abstract idea.
B. Regarding instant claim 13, Example 44 of the “2019 PEG” shows a similar fact
pattern. Claim 1 in example 44 is drawn to denveric acid. The markedly different characteristics
analysis is used to determine if the nature-based product limitation is a product of nature
exception. MPEP 2106.04(c)(I). Although the claim also recites a non-nature based product
limitation (the container), the markedly different characteristics analysis should be applied only
to the nature- based product limitation. MPEP 2106.04(c)(I)(A). The markedly different
characteristics analysis is performed by comparing the nature-based product limitation in the
claim to its naturally occurring counterpart to determine if it has markedly different
characteristics from the counterpart. MPEP 2106.04(c)(II). Here, the closest natural counterpart
is naturally occurring denveric acid. When the claimed denveric acid is compared to this
counterpart, the comparison indicates that there are no differences in structure, function, or
other characteristics. Therefore, the claimed denveric acid is a product of nature exception.
Association for Molecular Pathology v. Myriad Genetics Inc., 569 U.S. 576, 589-90 (2013)
(naturally occurring things are “products of nature” which cannot be patented).”
Similarly, instant claim 13 recites the use of adiponectin, ferritin, MMP9, and transferrin. The closest natural counterpart to adiponectin, ferritin, MMP9, and transferrin are naturally occurring adiponectin, ferritin, MMP9, and transferrin. When the claimed markers are compared to this counterpart, the comparison indicates that there are not differences in structure, function, or other characteristics.
Accordingly, instant claims 1-20 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?
A. 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 1 does 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 a step of general treatment. Instant claim 1 doesn’t recite a treatment step. Instant claim 1 recites looking at the levels of specific biomarkers in response to a treatment and thus is not considered a treatment step. Example 43 failed with a step of a general treatment, instant claim 1 does not recite a further active step, let alone a treatment.
Instant claim 12 does 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 a step of general treatment. Instant claim 12 doesn’t recite a treatment step. Instant claim 12 recites looking at the levels of specific biomarkers in response to a treatment and thus is not considered a treatment step. Example 43 failed with a step of a general treatment, instant claim 12 does not recite a further active step, let alone a treatment.
Instant claim 15 does 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 a step of general treatment. Like Example 43, instant claim 15 recites a general treatment. Claim 1 of Example 43, even with a general treatment, fails to have additional elements that would integrate the judicial exception into a practical application. Instant claim 15 further recites various timing of the administration of a treatment, however, that does not change the fact that instant claim 15 is directed to a law of nature that does not integrate the judicial exception into a practical application.
Dependent claims 2-11, 14, and 16-20 do not have additional elements that would integrate the judicial exception into a practical application.
B. Regarding instant claim 13, Example 44 of the “2019 PEG” shows a similar fact
pattern. In claim 1 of example 44 of the “2019 PEG” and per Step2A, Prong two, the 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. 2019 PEG Section III(A)(2), 84 Fed. Reg. at 54-55. Claim 1 recites an additional
element (the container). Although this limitation indicates that the denveric acid is held in the
container, it does not provide any information as to how the denveric acid is contained, or what
the container is, but instead covers any possible container that a doctor or pharmacist decides
to use. Because denveric acid must be placed in a container in order to store and use it, merely
reciting a generic “container” thus fails to meaningfully limit the claim because it is at best the
equivalent of merely adding the words “apply it” to the judicial exception. Accordingly, the container does not integrate the recited judicial exception into a practical application and the
claim is therefore directed to the judicial exception (Step 2A: YES)”.
While example 44 recites a container which was still was not deemed sufficient, instant claim 13 does not recite any container and contains no more than adiponectin, ferritin, MMP9, and transferrin biomarkers (the natural products). Example 44 did not pass Step 2A prong 2 with the additional element (the container). Accordingly, instant claim 13 does not have additional elements that would integrate the judicial exception cited above into a practical application.
Therefore, instant claims 1-20 do not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
A. Regarding claim 1 of example 43 of the “2019 PEG” and per Step 2B, 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 recites a single additional element in limitation (b), which 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. Mere instructions to apply an
exception cannot provide an inventive concept (Step 2B: NO). The claim is not eligible.
Similarly, instant claim 1 recites “in vitro measuring levels of a combination of biomarkers consisting of adiponectin, ferritin, MMP9 and transferrin in a biological sample from the patient”, which recites mere instructions of obtaining a judicial exception, and cannot be considered an inventive concept. Instant claim 1 further recites “assessing the effectiveness of the treatment with lanifibranor as a function of the levels measured in step a)” which recites simply observing the naturally occurring proteins, which does not amount to significantly more (STEP 2B: NO).
Instant claim 12 recites the additional limitation of “a) a means for measuring or receiving measurement data of levels of a combination of biomarkers consisting of adiponectin, ferritin, MMP9 and transferrin in a biological sample from the patient; and b) a means for processing the data configured to assess the effectiveness of the treatment with lanifibranor in the patient as a function of the levels measured for the combination of biomarkers”. The additional elements of a-b do not amount to significantly more than the judicial exception because the limitations are merely data gathering steps that are directed towards the judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Accordingly instant claim 12 is not eligible (STEP 2B: NO).
Instant claim 15 recites the additional elements of “b) daily administering an effective amount of lanifibranor to the subject for at least 3 months; c) in vitro measuring levels of MMP9 and transferrin in a biological sample of the subject after at least 3 months of treatment; d) assessing the effectiveness of the treatment with lanifibranor as a function of the levels measured in steps a) and c), whereby a response or a non-response to the lanifibranor treatment can be predicted; and e) continuing administering an effective amount of lanifibranor to the subject for at least another 3 months provided the assessment made in step d) is predictive of a response to the lanifibranor treatment, or that no diagnostic can be made”. The additional elements of b-e do not amount to significantly more than the judicial exception because the limitations are merely data gathering steps that are directed towards the judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Accordingly, instant claim 15 is not eligible (STEP 2B: NO).
Dependent claims 2-11, 14, and 16-20 do not amount to significantly more than the judicial exception. The limitations are merely data gathering steps that are directed towards the judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Accordingly, instant claims 2-11, 14, and 16-20 are not eligible (STEP 2B: NO).
B. Regarding instant claim 13, 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 discussed with respect to Step 2A Prong Two, the claims do not even
recite a container or any additional elements. (Step 2B: NO). The claims are not eligible.
Thus, instant claims 1-20 are rejected under 35 USC 101.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art does not teach or suggest the claimed invention of measuring the levels of a combination of biomarkers consisting of adiponectin, ferritin, MMP9 and transferrin in a biological sample from a patient in order to assess the effectiveness of the treatment with lanifibranor.
The closest prior art is Wlazlo et al., “Iron metabolism is associated with adipocyte insulin resistance and plasma adiponectin: the Cohort on Diabetes and Atherosclerosis Maastricht (CODAM) study.” Diabetes care vol. 36,2 (2013): 309-15. doi:10.2337/dc12-0505.
Wlazlo teaches measuring adiponectin, ferritin, and transferrin in a biological sample from a subject who has a history of liver disease.
Wlazlo does not teach the use of lanifibranor.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MCKENZIE A DUNN whose telephone number is (571)270-0490. The examiner can normally be reached Monday-Tuesday 730 am -530pm, Wednesday-Friday 730 am-430 pm.
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/MCKENZIE A DUNN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
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