Prosecution Insights
Last updated: August 14, 2026
Application No. 17/422,051

MULTIPLEXED ASSAY AND METHODS OF USE THEREOF

Final Rejection §101§103
Filed
Jul 09, 2021
Priority
Jan 09, 2019 — provisional 62/790,290 +1 more
Examiner
DUNN, MCKENZIE A
Art Unit
1678
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Washington University
OA Round
2 (Final)
54%
Grant Probability
Moderate
3-4
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 54% of resolved cases
54%
Career Allowance Rate
42 granted / 78 resolved
-6.2% vs TC avg
Strong +55% interview lift
Without
With
+55.3%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
36 currently pending
Career history
117
Total Applications
across all art units

Statute-Specific Performance

§101
13.7%
-26.3% vs TC avg
§103
39.5%
-0.5% vs TC avg
§102
19.7%
-20.3% vs TC avg
§112
20.6%
-19.4% vs TC avg
Black line = Tech Center average estimate • Based on career data from 78 resolved cases

Office Action

§101 §103
DETAILED ACTION Claims 18, 21-23, and 38-49 are pending. Election/Restrictions Applicant’s election of group I, claims 18, 21-23, and 38-41 in the reply filed on 01/20/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 42-49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/20/2026. The species election for claim 18 filed on 10/20/2025 has been withdrawn. Claims 18, 21-23, and 38-41 are under examination. Status of Claims Claims 18 and 21-22 have been amended. Claims 38-41 have been newly added. Claims 18, 21-23, and 38-41 are under examination. Withdrawn Claim Objections and/or Rejections The arguments filed on 07/10/2025 have been considered by the examiner. The objection of claims 18-29 for informalities as set forth on p. 2 of the previous office action (mailed on 02/11/2025) has been withdrawn in view of the amended and cancelled claims (filed on 01/20/2026). The rejection of claim 22 under 35 USC 112(a) for failing to comply with written description as set forth on pp. 3-4 of the previous office action (mailed on 02/11/2025) has been withdrawn in view of the amended claim (filed on 01/20/2026). The rejection of claims 18-21 and 23-29 under 35 USC 103 as being unpatentable over Eyk, Korolev, and Bateman et al., as set forth on pp. 8-15 of the previous office action (mailed on 02/11/2025) has been withdrawn in view of the amended and cancelled claims (filed on 01/20/2026). The rejection of claim 22 under 35 USC 103 as being unpatentable over Eyk, Korolev, Bateman, and Tarawneh et al., as set forth on p. 15-16 of the previous office action (mailed on 02/11/2025) has been withdrawn in view of the amended claim (filed on 01/20/2026). The rejection of claims 18-21 and 23 for nonstatutory double patenting over U.S. Patent No. 12066444 as set forth on pp. 17-18 of the previous office action (mailed on 02/11/2025) has been withdrawn in view of the amended and cancelled claims (filed on 01/20/2026). 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 18, 21-23, and 38-41 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 18, 21-23, and 38-41, 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 18, 21-23, and 38-41. 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 18, 21-23, and 38-41 are directed to a statutory method that measures ApoE ε4, Aβ42/Aβ40, and optionally a marker of neurodegeneration in a blood sample and correlates the levels of naturally occurring markers with a subject who is a candidate for further testing (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 18, 21-23, and 38-41, 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 18, 21-23, and 38-41 recites “measuring concentration levels” of proteins and correlating those measurements to identify a candidate for further diagnostics testing, which described a naturally occurring relationship between the protein biomarker and further diagnostic testing, and thus is considered a law of nature. Further, instant claims 18, 21-23, and 38-41 recite “determining/identifying the subject as a candidate for further testing” by comparing age and the measurement of proteins, 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. Instant claims 18, 21-23, and 38-41 recite “calculating” a value. The recitation of “calculating” 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. Consequently, claims 18, 21-23, and 38-41 recite the judicial exception of applying and using a law of nature and an abstract idea. Accordingly, instant claims 18, 21-23, and 38-41 recite a judicial exception (a law of nature and an abstract idea that falls within the mental process grouping and mathematical concept 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 18, 21-23, and 38-41, 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 18, 21-23, and 38-41 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 18, 21-23, and 38-41 do not recite any additional elements other than the law of nature and the abstract idea. 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 limitation of performing/administering further diagnostic testing, wherein the further diagnostic testing is an MRI, CT, fMRI, PDG-PET, PIB-PET, florbetaben-PET, florbetapir-PET, or flutemetamol-PET does not integrate the recited judicial exception into a practical application and the claim is therefore directed to a judicial exception. Further, instant claims 18, 21-23, and 38-41 do not even recite a general treatment. Example 43 failed with the step of a general treatment, instant claims 18, 21-23, and 38-41 do not even recite a further active step, let alone a step for treatment. Therefore, instant claims 18, 21-23, and 38-41 do not integrate the judicial exception into a practical application. Step 2B: Does the claim recite significantly more? Regarding instant claims 18, 21-23, and 38-41 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 claims 18, 21-23, and 38-41 recite “administering further diagnostic testing”, the diagnostic testing is not applying the judicial exception into a practical application, the further diagnostic testing is just confirming the results of the judicial exception. The recitation of “administering further diagnostic testing” is equivalent to adding the words “apply it” to the judicial exception. Thus, claims 18, 21-23, and 38-41 do not recite any active steps. Accordingly, instant claims 18, 21-23, and 38-41 are not eligible (STEP 2B: NO). Thus, instant claims 18, 21-23, and 38-41 are rejected under 35 USC 101. Claim Rejections - 35 USC § 101-Response to Arguments The arguments filed on 07/10/2025 have been considered by the examiner. On pp. 10-11 applicant argues that the instant claims integrate the purported judicial exception into a claimed process that amounts to more than merely identifying a subject as a candidate for further diagnostic testing based on natural law. However, the instant application is still directed towards a judicial exception. The instant application recites measuring biomarkers (naturally occurring) and correlating the measurement of those naturally occurring markers to a subject who needs further diagnostic testing, which is directed towards a law of nature. Further, the instant application recites “determining” and “identifying” which are 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). The instant claim also recites “calculating” a value, which is directed toward an abstract idea that falls into the “mathematical concept” grouping. The instant application recites “administering a further diagnostic test”, which at best is equivalent to adding the words “apply it” to the judicial exception. On p. 11 applicant directs the examiner to Example 2. While it is understood the instant methods are beneficial for diagnostics, the instant application still recites several judicial exceptions and does not amount to significantly more than the judicial exception itself. 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 18, 21, 23, 38, and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al. Aging and APOE-ε4 are determinative factors of plasma Aβ42 levels. Annals of Clinical and Translational Neurology. 2018 Oct;5(10):1184-1191. DOI: 10.1002/acn3.635. PMID: 30349853; PMCID: PMC6186936, in view of Fandos, Noelia et al. “Plasma amyloid β 42/40 ratios as biomarkers for amyloid β cerebral deposition in cognitively normal individuals.” Alzheimer's & dementia (Amsterdam, Netherlands) vol. 8 179-187. 12 Sep. 2017, doi:10.1016/j.dadm.2017.07.004. Instant claim 18 recites “A method for identifying a subject as a candidate for further diagnostic testing, the method comprising: determining the age and apolipoprotein E (ApoE) ε4 status of the subject; and measuring the concentration of amyloid beta (Aβ)42 and Aβ40 in a blood sample obtained from the subject and calculating an Aβ42/Aβ40 value; and(a) identifying the subject as a candidate for further diagnostic testing when the subject is ApoE ε4 positive, and(i) the subject is at least 55 years old and the blood sample has an Aβ42/Aβ40 value of 0.1032 or less;(ii) the subject is at least 60 years old and the blood sample has an Aβ42/Aβ40 value of 0.1094 or less;(iii) the subject is at least 65 years old and the blood sample has an Aβ42/Aβ40 value of 0.1156 or less;(iv) the subject is at least 70 years old and the blood sample has an Aβ42/Aβ40 value of 0.1218 or less;(v) the subject is at least 75 years old and the blood sample has an Aβ42/Aβ40 value of 0.128 or less;(vi) the subject is at least 80 years old and the blood sample has an Aβ42/Aβ40 value of 0.1342 or less; or (vii) the subject is at least 85 years old and the blood sample has an Aβ42/Aβ40 value of 0.1404 or less, or (b) identifying the subject as a candidate for further diagnostic testing when the subject is ApoE ε4 negative, and(i) the subject is at least 60 years old and the blood sample has an Aβ42/Aβ40 value of 0.1032 or less;(ii) the subject is at least 65 years old and the blood sample has an Aβ42/Aβ40 value of 0.1094 or less;(iii) the subject is at least 70 years old and the blood sample has an Aβ42/Aβ40 value of 0.1156 or less;(iv) the subject is at least 75 years old and the blood sample has an Aβ42/Aβ40 value of 0.1218 or less;(v) the subject is at least 80 years old and the blood sample has an Aβ42/Aβ40 value of 0.128 or less; or (vi) the subject is at least 85 years old and the blood sample has an Aβ42/Aβ40 value of 0.1342 or less, and administering a further diagnostic test to the subject identified as candidate for further diagnostic testing, wherein the further diagnostic test is a cerebral spinal fluid (CSF) test that measures the concentration of one or more biomolecules in the CSF, wherein the one or more biomolecules are selected from A3 peptide, tau, phospho-tau, neurofilament light chain, visinin-like protein one, or ApoE;a structural imaging test selected from magnetic resonance imaging (MRI) or computed tomography (CT);a functional imaging test selected from positron emission tomography (PET), functional magnetic resonance imaging (fMRI), or fluorodeoxyglucose (FDG)-PET; or a molecular imaging test selected from Pittsburgh compound B (PIB)- PET, florbetaben-PET, florbetapir-PET, or flutemetamol-PET.”. Nakamura teaches a method for identifying a subject as a candidate for further diagnostic testing (see abstract “The aim of this study was to confirm determinative factors for plasma Ab and its association with cognitive function. Methods: Fasting plasma Aβ40 and Aβ42 levels were measured by ELISA in 1019 participants in the Iwaki Health Promotion Project. The relationships between plasma Ab and health-related items, including physical characteristics, cognitive function tests, blood chemistry, and APOE-4 genotype were analyzed.”), the method comprising: determining the age and apolipoprotein E (ApoE) ε4 status of the subject (see abstract “Age and APOE-e4 are major determinative factors of plasma levels of Ab42 and the Ab40/42 ratio. These factors are critical adjustment factors for the usage of plasma Ab as a biomarker of central nervous system amyloidosis”); and measuring the concentration of amyloid beta (Aβ)42 and Aβ40 in a blood sample obtained from the subject and calculating an Aβ42/Aβ40 value (see table 1, see abstract “Fasting plasma Ab40 and Ab42 levels were measured by ELISA in 1019 participants in the Iwaki Health Promotion Project. The relationships between plasma Ab and health-related items, including physical characteristics, cognitive function tests, blood chemistry, and APOE-e4 genotype were analyzed”); and identifying the subject as a candidate for further diagnostic testing when the subject is ApoE ε4 positive (see page 1186 under “Plasma Aβ levels and relationship with APOE genotype”); and identifying the subject as a candidate for further diagnostic testing, and administering a further diagnostic test to the subject identified as candidate for further diagnostic testing, wherein the further diagnostic test is a functional imaging test selected from positron emission tomography (PET) (see page 1184 “The Alzheimer’s Disease Neuroimaging Initiative (ADNI) and the Dominantly Inherited Alzheimer Network (DIAN) have confirmed the efficacy of neuropsychiatric tests and neuroimaging using cerebrospinal fluid (CSF) biomarkers, including amyloid PET, demonstrating that signatures of brain Aβ amyloidosis can be found approximately 30 years before the onset of dementia.”) (instant claims 18 and 40). Nakamura teaches determining the concentration of one or more markers of neurodegeneration (see abstract “Age and APOE-e4 are major determinative factors of plasma levels of Aβ42 and the Aβ40/42 ratio. These factors are critical adjustment factors for the usage of plasma Ab as a biomarker of central nervous system amyloidosis.”) (instant claim 21). Nakamura teaches the subject is a potential participant in a clinical trial for a disease associated with Aβ amyloidosis (see page 1189 “For this reason, adjustments of the plasma Aβ42 level and Aβ40/42 ratio for age, and APOE-e4 allele at any age are essential for evaluating plasma Aβ levels as biomarkers of the progress of brain Aβ amyloidosis or clinical trials of disease modifying drugs.”) (instant claim 23). Nakamura does not teach the subject is at least 65 years old and the blood sample has an Aβ42/Aβ40 value of 0.1156 or less. Nakamura does not teach measuring Aβ peptide in CSF, nor does Nakamura teach using Pittsburgh compound B (PIB)-PET or flutemetamol-PET. Fandos teaches the subject being at least 65 years old and the blood sample has Aβ42/Aβ40 value of 0.1156 or less (see table 1 showing ages from 72-78.9 years old with TP 42/40, BP 42/40, and FP 42/40 all being below 0.1156. See page 180 “Moreover, we have taken a comprehensive approach for the evaluation of Aβ42/40 plasma ratio, differentiating the peptide fractions that are found free in plasma (FP42/40) from the total Aβ peptides in plasma (TP42/40) and the amount of Aβ that is bound to other plasma components (BP42/40), by means of validated enzyme-linked immunosorbent assays (ELISAs)”) (instant claim 18). Fandos teaches measuring an Aβ peptide in CSF (see page 185 “In line with this, recent studies in CSF have reported better diagnostic performance for the Aβ42/40 ratio than for Aβ42 alone” see page 180 “Aβ peptides are most frequently measured in the cerebrospinal fluid (CSF)”) (instant claim 38). Fandos further teaches the diagnostic test is a molecular imaging test selected from Pittsburgh compound B (PIB)-PET or flutemetamol-PET (see page 180 “At each of these time points, cortical Aβ burden was assessed using PET with either 11C-Pittsburgh Compound-B (PiB) or 18F-flutemetamol. The PET methodology for each tracer has been previously described [34,35] (see Supplementary material, Imaging Methods for detailed description).”) (instant claim 41). 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 Aβ42/40 in an individual taught by Nakamura with the methods of detection of Aβ42/40 taught by Fandos. Fandos provides motivation by teaching measuring Aβ in CSF and/or through Aβ-pet scans have both demonstrated high diagnostic and prognostic value (see page 180). Fandos further provides motivation by teaching that Aβ 42/40 ratio has a better diagnostic performance in CSF than just Aβ42 alone (see page 185). The artisan would have had reasonable expectation of success at the time of the instant application based on the cumulative disclosures of these prior art references Claims 22 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura and Fandos as applied to claims 18, 21, 23, 38, and 40-41 above, in view of Fossati et al. “Plasma tau complements CSF tau and P-tau in the diagnosis of Alzheimer's disease.” Alzheimer's & dementia (Amsterdam, Netherlands) vol. 11 483-492. 28 Jun. 2019, doi:10.1016/j.dadm.2019.05.001. The teachings of Nakamura and Fandos as it pertains to claims 18, 21, 23, 38, and 40-41 is discussed in the 35 USC 103 above. Nakamura and Fandos do not teach the marker of degeneration being p-tau nor the diagnostic test being an MRI. Fossati teaches measuring p-tau in CSF (see page 484 “explore the diagnostic value of plasma tau and its usefulness in comparison to or in combination with CSF tau and P-tau, we measured plasma and CSF tau in 97 subjects including patients with AD and nondemented controls recruited at the Center for Brain Health of NYU Langone Medical Center.”) (instant claim 22) and using an MRI as a diagnostics test (see page 484 “we validated the agreement of the different assays by comparing CSF samples run with SIMOA and gold-standard ELISA assays and we examined the relationships of plasma tau with cognitive and structural magnetic resonance imaging (MRI) measures…The examinations included history, physical and neurological assessments, psychiatric screens, clinical laboratories, MRI…”, see page 485 under 2.5 Magnetic resonance imaging and processing) (instant claim 39). 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 Aβ42/40 in an individual taught by Nakamura with the methods of using CSF p-Tau to diagnose Alzheimer’s disease (AD) taught by Fossati. Fossati provides motivation by teaching that phosphorylated forms of tau (p-Tau) aggregate in neurofibrillary tangles, contributing to cognitive impairment, and elevated p-Tau is an established marker for a neurodegenerative disease such as AD (see page 484). Fossati provides motivation by teaching that clinical laboratories and MRI images are standard examinations consistent with NIH- National Alzheimer Coordinating Center (NACC) guidelines (see page 484), thus teaching it is routine in the art. Fossati provides further motivation by teaching that measuring CSF P-tau is the current gold standard for diagnostics of a neurodegenerative disease such as AD (see page 488). The artisan would have had reasonable expectation of success at the time of the instant application 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gregory Emch can be reached at (571)272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MCKENZIE A DUNN/ Examiner, Art Unit 1678 /GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678
Read full office action

Prosecution Timeline

Jul 09, 2021
Application Filed
Oct 10, 2022
Response after Non-Final Action
Feb 11, 2025
Non-Final Rejection mailed — §101, §103
Jul 10, 2025
Response Filed
Apr 21, 2026
Final Rejection mailed — §101, §103 (current)

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Prosecution Projections

3-4
Expected OA Rounds
54%
Grant Probability
99%
With Interview (+55.3%)
3y 11m (~0m remaining)
Median Time to Grant
Moderate
PTA Risk
Based on 78 resolved cases by this examiner. Grant probability derived from career allowance rate.

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