DETAILED ACTION
Claims 159, 164, ands 169-207 are pending.
Status of Claims
Claims 159, 164, ands 169-207 are pending.
Applicant's election with traverse of group II, claims 159 and 164 in the reply filed on 06/08/2026 is acknowledged. The traversal is on the ground(s) that group I and II share common technical features. This is not found persuasive because group II requires the additional feature of quantifying Aβ 42/40. The requirement is still deemed proper and is therefore made FINAL.
Applicant cancelled all claims not directed to the elected invention (claims 1-158). Claims 169-207 have been newly added.
Claims 159, 164, and 169-207 are under examination.
Priority
Claims 159, 164, and 169-207 do not qualify for the earlier priority date of the provisional application 63/169,193 because ‘193 does not teach or reference a method for discriminating a tauopathy.
Due to claims 159, 164, and 169-207 of the instant application not being supported by ‘193, claims 159, 164, and 169-207 of the instant application do not qualify for the earlier filing date of the provisional application 63/169,193.
The earliest priority date for claims 159, 164, and 169-207 is the 371 date 03/31/2022.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 07/23/2026 has been considered by the examiner.
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 159 and 169-187 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 159 and 169-187, 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.
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 159 and 169-187 are directed to a statutory method that measures one or more phospho-tau and Aβ species in a blood sample from a subject, then using that measurement to discriminate a tauopathy from a healthy state (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), 2019 Revised Patent Subject Matter Eligibility Guidance, PEG 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 159 and 169-187, Example 43 of the “2019 PEG” shows a similar fact pattern.
Regarding claim 1 of Example 43, Limitation (a) in the claim recites several nature- based product limitations including C11, C13, and the blood sample, which raises the question of whether the markedly different characteristics analysis should be used to determine if the
nature-based product limitations are product of nature exceptions. For a process claim, the
general rule is that the claim is not subject to the markedly different analysis for nature-based
products used in the process. MPEP 2106.04(c)(I)(C). While there is an exception to this
general rule for process claims that are drafted in such a way that they are no different in
substance than a product claim, claim 1 does not invoke this exception because review of this
claim indicates that it is focused on a process of determining how much C11 and C13 is present
in the blood sample and then treating a patient in accordance with that determination, and is not
focused on the products per se. Thus, the general rule expressed in the MPEP applies,
meaning that the markedly different characteristics analysis is not performed on the recited
nature-based product limitations, and the claim is not considered to “recite” any products of
nature for purposes of further eligibility analysis.
Similarly, instant claims 159 and 169-187 recite several nature-based product limitations including CSF, blood samples, one or more phospho-tau and Aβ species. While there is an exception to this general rule for process claims that are drafted in such a way that they are no different in substance than a product claim, instant claim 159 does not invoke an exception because review of this claim indicates that it is focused on a process of determining the presence/levels of phosphor-tau and Aβ species is present in a CSF or blood sample and then using those values to discriminate a tauopathy from a healthy state. Thus, the general rule expressed in the MPEP applies, meaning that the markedly different characteristics analysis is not performed on the recited nature-based product limitations, and the claim is not considered to “recite” any products of nature for purposes of further eligibility analysis. However, like claim 1 in Example 43, the instant claims 159 and 169-187, must then be further reviewed for any other type of judicial exception.
Example 43 of “2019 PEG” continues the analysis to determine whether it recites any
other type of judicial exception, 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.
Instant claim 159 recites “(c) calculating a composite value, wherein the calculation is pT217/T217 x Ap 42/40, wherein an increased composite value relative to a healthy control population indicates the subject as having or at an increased risk for Alzheimer's disease (AD)”, which describes a naturally occurring relationship between the one or more phosphor-tau and Aβ 42/40 and correlating it to a tauopathy, and thus is considered to recite a law of nature. Further, instant claim 159 recites “calculating a composite value, wherein the calculation is pT217/T217 x Ap 42/40”, which has a BRI that requires performing an arithmetic calculation (multiplication) in order to obtain a value relative to a healthy control in order to indicate the subject as being at risk for AD or a non-AD tauopathy. 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 (c) 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.
Further, instant claim 159 recites using the obtained phosphor-tau and Aβ 42/40 values to discriminate between a tauopathy and a healthy control, 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 collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind. Consequently, like example 43, instant claim 159 recites the judicial exception of applying and using a law of nature and an abstract idea.
Dependent instant claims 169-187 contain limitations that fall under a judicial exception. The dependent claims recite measurements of biomarkers and/or natural correlations of the presence and levels of biomarkers with a disease. Further, 169-187 recite “relative to” which has a BRI that requires a comparison between a subject’s biomarker levels to a healthy subject’s biomarker level, 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 collected information to a predetermined threshold, which is an act of evaluating information that can be practically performed in the human mind.
Accordingly, instant claims 159 and 169-187 recite a judicial exception (a law of nature and an abstract idea that falls within the mental process groupings) 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 159, 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 159 does not have additional elements that would integrate the
judicial exception cited above into a practical application. In comparison, claim 1 of Example 43
did not pass step 2A prong 2 with step of general treatment, instant claim 159 does not even recite any steps of treatment. Example 43 failed with the step of general treatment, instant
claim 169 does not even recite a further active step, let alone a step for treatment.
Therefore, instant claim 159 does not integrate the judicial exception into a practical application.
Step 2B: Does the claim recite significantly more?
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 159 recites the additional limitation of (a) providing a processed
CSF or blood sample obtained from a subject that is enriched for one or more phosphor-tau and
Aβ species which recites measuring naturally occurring biomarkers in a sample from a subject
which are mere instructions of obtaining a judicial exception and cannot be considered an
inventive concept. Accordingly, instant claim 159 is not eligible (STEP 2B: NO).
Instant claim 159 and the dependent claims 169-187 are rejected as ineligible under 35 USC 101.
Response to Arguments
A new 35 USC 101 was necessitated by the amendments.
Applicants’ arguments were aimed at the previously now moot rejections. However, where relevant, applicant’s arguments are addressed in light of the new 101 rejections.
Applicant's arguments filed on 03/17/2026 have been fully considered but they are not persuasive.
On p. 11-12 applicant argues that the instant claim set is not directed towards a judicial exception as it requires physically processing and enriching a CSF or blood sample and quantifying site-specific phosphorylation occupancy and an Aβ 42/40 value using laboratory techniques, and thus passes under step 2A.
However, while it is understood that there are physical steps that need to be carried out, the claims are still directed to a natural correlation (measuring biomarkers and correlating the levels to a disease). The physical steps do not overcome the 36 USC 101 rejection as they are merely done in order to correlate the levels to a disease (tauopathy), i.e., they are routine data gathering steps that must be undertaken to reveal the natural correlation.
Claim Rejections - 35 USC § 103: New, Necessitated by Amendments.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 159, 164, and 169-207 rejected under 35 U.S.C. 103 as being unpatentable over Barthelemy et al., (WO 2019213612A1) (IDS filed on 03/28/2024), in view of Sato, Chihiro et al. “MAPT R406W increases tau T217 phosphorylation in absence of amyloid pathology.” Annals of clinical and translational neurology vol. 8,9 (2021): 1817-1830. doi:10.1002/acn3.51435.
Barthelemy teaches a method of discriminating a tauopathy, the method comprising
(a) providing a processed CSF or blood sample obtained from a subject (see [0060] “An isolated tau sample, as used herein, refers to a composition comprising tau, wherein tau has been purified from blood or cerebrospinal fluid (CSF) obtained from a subject.”) (instant claims 173-174), wherein the CSF or blood sample is enriched for one or more phospho-tau and Aβ species (see [0139] “Our results demonstrate that several phosphorylated residues are significantly enriched in the CSF compared to brain extracts, such as T217, T231, T153 and T111. All are proline-directed sites, are potential substrates of GSK-3P protein kinase, and may be subject to kinase-dependent regulation. Unlike pT217, pS214 was not elevated in the CSF compared to the brain. This extracellular enrichment of pT217 over pS214 agreed with kinetic differences we previously identified within cells for these isoforms (Sato et al., 2018), with pT217 having a shorter turnover rate than”);
(b) quantifying, in the processed sample, a phospho-tau value and an Aβ 42/40 value,
wherein a significantly different phospho-tau value and/or Aβ 42/40 value discriminates a
tauopathy from a healthy state (see [0010] “In another aspect, the present disclosure
encompasses a method to stage a subject after onset of Alzheimer’s disease (AD) symptoms.
The method comprises (a) providing an isolated tau sample obtained from a subject and
measuring, in the isolated tau sample, tau phosphorylation at one or more amino acid residue
chosen from T181 , T205 and T217 and optionally measuring total tau; and (b) diagnosing the
subject as being a certain number of years after onset of MCI due to AD when the measured
phosphorylation level(s) significantly deviate from the mean in a control population without brain
amyloid plaques as measured by PET imaging and/or Ab42/40 measurement in CSF.
Alternatively, or in addition to, using a measurement of tau phosphorylation at T181, T205
and/or T217, optionally with a measurement of total tau, a ratio calculated from the measured
phosphorylation level(s), or a ratio calculated from the measured phosphorylation level(s) and
total tau, may be used. A ratio calculated from the measured phosphorylation level(s) may be a
ratio between p-T181 and p-T205, p-T217 and p-T205, or p-T181 and p-T217. A ratio calculated
from the measured phosphorylation level(s) and total tau may be a ratio between p-T181 and
total tau, p-T205 and total tau, or p-T217 and total tau. Mathematical operations other than a
ratio may also be used.”, see [0271] “This profile allows the discrimination of AD versus non-AD pathologies and the detection of AD process many years prior to cognitive symptoms or
complaint.”) (instant claim 159). Barthelemy teaches tau therapy or Aβ therapy is administered when subjects have a certain tau phosphorylation level (see [0090], see [0102], see claims 131-132 of Barthelemy) (instant claims 164 and 188-191). Barthelemy teaches the non- AD tauopathy population comprises of one or more subjects having FTD. PSP, or CBD (see [0143]) (instant claim 172).
Barthelemy teaches the processed sample is enriched for phospho-tau species prior to quantifying the phospho-tau value (see [0147]) (instant claim 175) and the value is determined using mass spectrometry (see [0147]) (instant claim 176). Barthelemy teaches the phospho-tau is normalized to a corresponding total tau value (see [0151]) (instant claim 177). Barthelemy teaches assigning percentile rank relative to a healthy control (see [0206] teaching the % risk of having AD) (instant claim 184-185). Barthelemy teaches the increased value is at least 1 standard deviation above a mean value of the healthy control population (see claim 1, see [0080]) (instant claim 186).
Barthelemy teaches the treatment being a tau targeting therapy that alters tau phosphorylation patterns, and/or antagonize tau aggregation (see [0089]) (instant claims 193-195), the treatment increases clearance of pathological tau isoforms and/or tau aggregates (see [0089]) (instant claim 196), and the use of anti-tau antibodies (see [0098]) (instant claims 197-198). Barthelemy teaches the use of tau protein aggregation inhibitor TRx0237 (see [0098]) (instant claims 199-200). Barthelemy teaches the use of kinase inhibitors TAOK, CDK, MARK, CDK5, and/or Fyn (see [0099]) (instant claims 201-202). Barthelemy teaches the use of a phosphatase activator that increases protein phosphatase 2A (see [0100]) (instant claims 203-204). Barthelemy teaches the use of anti-Aβ antibodies (see [0098]) (instant claim 205), and the use of beta-secretase inhibitors and gamma-secretase inhibitors (see [0098], see [0114]) (instant claims 206-207). Barthelemy teaches quantifying one or more additional p-tau values selected from pT181/T181 and/or pT205/T205 (see claim 1) (instant claim 187). While Barthelemy does not explicitly state obtaining a subsequent sample from the subject following the administration of the therapy, Barthelemy does teach determining the efficacy of the therapeutic agents and determining if the therapeutic agent is effective or not (see [0090]). It would have been obvious to one of ordinary skill to routinely optimize the frequency in which a sample is measured after therapy in order to determine if the therapy is effective. Absent evidence of the contrary, the frequency in which a subject is tested (before and after a therapy) would be an obvious matter of choice (instant claim 192).
Barthelemy does not teach (c) calculating a composite value, wherein the calculation is pT217/T217 x Aβ 42/40, wherein an increased composite value relative to a healthy control population indicates the subject as having or at an increased risk for Alzheimer's disease (AD), nor does Barthelemy teach a reference composite.
Sato teaches that detection of pT217 in cerebrospinal fluid (CSF) has been linked to AD (see abstract). Sato teaches calculating a composite value, wherein the calculation is pT217/T217 x Aβ 42/40 (see abstract), wherein an increased composite value relative to a healthy control population indicates the subject as having or at an increased risk for Alzheimer's disease (AD) and/or diagnosing AD (see abstract “Individuals with AD had high CSF pT217/T217 and low Ab42/40. In contrast, cognitively normal individuals and the majority of those with 4R tauopathies had low CSF pT217/T217 and normal Ab 42/40.”, see page 1826 “We evaluated diagnostic values of CSF pT217/T217 and CSF Ab 42/40 alone and in combination. CSF pT217/T217 levels were increased in MAPT R406W mutation carriers”) (instant claims 159, 169-171, 178, and 184-186). Sato teaches wherein the subject is diagnosed with having AD when a composite value exceeds the reference composite value (see table 1, see page 1823 under “Diagnostic values…”, where the reference composite value is referred to as the “control”) (instant claims 179 and 181). Sato teaches the reference value (control) is compared to a composite value determined from non-AD tauopathy populations (see page 1818 under “introduction”, see table 1, see page 1822 under “Association between IP/MS CSF Aβ 42/40 and CSF pT217/T217”) (instant claim 180). Sato teaches that the composite value is compared to a predetermined threshold (see table 2 showing a cutoff and page 1823 under “MAPT R406W carriers…” for an explanation of table 2, see figure 2) (instant claim 182). Sato teaches wherein the subject is diagnosed or is at risk for having AD when the composite value exceeds the predetermined threshold value (see figure 2, see page 1823 under “Diagnostic values of IP/MS CSF…”) (instant claim 183).
It would have been obvious to one of ordinary skill in the art at the time of the instant application to combine the methods of measuring Aβ 42/40 and pT217/T217 to discriminate a tauopathy taught by Barthelemy with the method of calculating a composite value taught by Sato. Sato teaches that using a composite value is beneficial because pT217/T217 x Aβ 42/40 is a sensitive composite biomarker that can separate MAPT R406W carriers form cognitively normal individuals and those with other tauopathies (see abstract). The artisan would have reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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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