DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claim set entered 17 March 2026 has been entered into the application.
Claims 1 is amended.
Claim 8 is cancelled.
Claim(s) 1-7 and 9-15 are pending.
Restrictions
Applicant’s election without traverse of Group I, claims 1-15, drawn to a method to predict mortality to alcoholic hepatitis, in the reply filed on 14 October 2024 is acknowledged.
Claims 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 14 October 2024.
Claim 1-7 and 9-15 are pending examination.
Priority
Acknowledgment is made of applicant’s claim for priority to PCT/US2019/060290 filed 07 November 2019 which claims priority to U.S Provisional Application 62/757.505 filed 08 November 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on was filed 03 March 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 101
The instant rejection is maintained for reason of record in the Office Action mailed 17 December 2025 and modified in view of the amendments filed 17 March 2026.
The rejection of claim 8 under 35 U.S.C § 101 in the Office Action mailed 17 December 2025 is withdrawn in view of the amendments received 17 March 2026 because the claim was cancelled.
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 1-7 and 9-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim Analysis
Under broadest reasonable interpretation (BRI), claim 1 is directed towards a method of predicting patient mortality to alcoholic hepatitis that requires acquiring NMR spectrum data (i.e., LP-X and LP-Z and ApoB concentrations) from an NMR spectrometer and using a computer to determine LP-Z and ApoB concentrations from the NMR spectrum data, and calculating a Z-index score for indicating a patient mortality rate.
Following the Flowchart of the MPEP 2106
Step I - Process, Machine, Manufacture or Composition
Claims 1-7 and 9-15 are directed towards a method, so a process.
2A Prong I - Identification of an Abstract Idea
Claim 1 recites:
Using the NMR spectrum, programmatically determining a concentration of LP-Z and a concentration of total apoB-containing lipoproteins in the bio sample based on the NMR spectrum of the bio sample
This step can be performed in the human mind by observing, evaluating, and organizing data (i.e., NMR spectrum data of a bio sample) to determine a concentration of LP-Z and a concentration of total apoB-containing lipoproteins and is therefore an abstract idea.
wherein the NMR spectrum of the bio sample includes LP-X and LP- Z
This step describes the NMR spectrum of the bio sample as including LP-X and LP- Z.
calculating a Z index score based on the concentration of the LP-Z and the concentration of the total apoB-containing lipoproteins in the bio sample.
This step can be performed in the human mind by organizing data (i.e., concentration of the LP-Z and the concentration of the total apoB-containing lipoproteins) to calculate a Z index score and is therefore an abstract idea. This step encompasses performing calculations to calculate a Z index score which reads on mathematical and is therefore an abstract idea.
wherein the Z index is a ratio of LP-Z concentration to total apoB-containing lipoproteins concentration
This step encompasses a ratio of LP-Z concentration and total apoB-containing lipoprotein concentration which encompasses mathematical concepts (i.e., ratios) which reads on abstract ideas.
indicating a patient mortality rate based on the Z index score
This step can be performed in the human mind by observing and evaluating the Z index score for indicating and/or to indicate a patient mortality rate and is therefore an abstract idea.
Dependent claims 2-7 and 9-13
Claim 2 recites producing a measured lipid signal lineshape for an NMR spectrum of the bio sample obtained from a subject.
This step can be performed in the human mind by organizing data (i.e., NMR spectrum) to produce a measured lipid signal lineshape and is therefore an abstract idea.
Claim 2 recites generating a calculated lineshape for the bio sample.
This step can be further performed in the human mind by following instructions to generate a calculated lineshape for the bio sample and is therefore an abstract idea. This step encompasses performing calculations to generate a calculated lineshape for the bio sample which encompasses performing mathematical calculations for generating a lineshape which reads on abstract ideas. Here, the term “generate” is interpreted as an alternative term for “calcualting”. See MPEP 2106.04(a)(2)(I)(C).
Claim 3 recites wherein the calculated lineshape is based on derived concentrations of lipoprotein components comprising LP-X and LP-Z.
This step describes the lineshape as based on the based on derived concentrations of lipoprotein components comprising LP-X and LP-Z. This step encompasses mathematical relationships of using calculated line shapes that are based on calculated “derived” concentrations of lipoproteins components comprising LP-X and LP-Z which reads on abstract ideas. Here, the term “derived” is interpreted as an alternative term for “calcualting”. See MPEP 2106.04(a)(2)(I)(C).
Claim 4 recites wherein the derived concentration of each of the lipoprotein components is a function of a reference spectrum for that component and a calculated reference coefficient.
This step describes the derived concentration of each lipoprotein components is a function of a reference spectrum and a calculated reference coefficient. This step encompasses mathematical concepts such as functions and calculated reference coefficients which reads on mathematical concepts.
Claim 5 recites wherein generating step comprises calculating the reference coefficients for the calculated lineshape based on a linear least squares fit technique.’
This step can be performed in the human mind by organizing data to generate the reference coefficients for the calculated lineshape based on linear least squares fit technique. This step encompasses performing mathematical computations for generating by calcualting the reference coefficients for the lineshape based on the linear least squares fit techniques which reads on mathematical concepts.
Claim 6 recites determining a degree of correlation between the initial calculated lineshape of the bio sample and a measured lineshape of the bio sample.
This step encompasses organizing data to determine a degree of correlation between the initial calculated lineshape and the measured lineshape and is therefore an abstract idea. This step encompasses performing mathematical/statistical calculations to determine a degree of correlation between lineshape of the biological samples which reads on abstract ideas/mathematical concepts. Here, the term “determining” is interpreted as an alternative term for “calcualting”. See MPEP 2106.04(a)(2)(I)(C).
Claim 6 recites determining the presence of LP-Z based on the calculated lineshape if the degree of correlation between the calculated lineshape and the measured lineshape of the bio sample is above a predetermined threshold.
This step can be performed in the human mind by observing, comparing, and judging whether the degree of correlations between the calculated and the measured lineshape of the bio sample is above a threshold and is therefore an abstract idea. This step encompasses using the mathematical concepts of equalities and inequalities for determining whether determining the presence of LP-Z based on the calculated lineshape is above a threshold which reads on mathematical concepts.
Claim 7 recites wherein the Z index score comprises a concentration of lipoprotein LP-Z, LDL, and VLDL.
This step describes the Z-index score as a concentration of the lipoprotein LP-Z, LDL, and VLDL.
Claim 9 wherein the Z index score is calculated by the following equation: Z index=([LP-Z] )/ ( [VLDL] + [LDL] + [LP -Z]).
This step describes the Z index score as calculated by the following equation: Z index=( [LP-Z] )/ ( [VLDL] + [LDL] + [LP -Z]). This step encompasses the mathematical concepts of using formulas which reads on abstract ideas.
Claim 10 recites wherein a Z index score of greater than 0.6 predicts patient mortality will occur in 90 days or less.
This step describes a Z index score of greater than 0.6 predicts patient mortality will occur in 90 days or less.
Claim 11 recites wherein the method predicts a likelihood of patient mortality within 90 days.
This step describes the method as predicting a likelihood of patient mortality with 90 days.
Claim 12 recites wherein the method predicts a likelihood of survival or patient response to treatment.
This step describes the method as a predictor of a likelihood of survival or patient response to treatment.
Claim 13 recites deconvolving the NMR spectrum.
This step can be performed in the human mind by following instructions to deconvolve the NMR spectrum data and is therefore an abstract idea before programmatic determination.
Claim 13 recites calculating NMR derived measurements of a plurality of selected lipoprotein parameters based on the deconvolved NMR spectrum.
This step can be performed in the human mind by organizing data to perform mathematical calculations for calculating NMR derived measurements of a plurality of selected lipoprotein parameters based on the deconvolved NMR spectrum and is therefore an abstract idea. This is encompasses performing mathematical calculations to calculate NMR derived measurements of a plurality of selected lipoprotein parameters based on the deconvolved NMR spectrum which reads on abstract ideas.
2A Prong II - Consideration of Practical Application
Claim 1 does not recite any additional elements that integrate the recited judicial exception into a practical application. Here, in the instant case, the claims merely set for a method of data analysis for determining a concentration of LP-Z and a concentration of total apoB-containing lipoproteins in the bio sample using NMR spectrum for subsequently calculating a Z index score for indicating a patient mortality rate. Such a result only produces information (i.e., Z index score indicating patient mortality rate) and does not provide for a practical application in the physical-realm of physical things and acts, i.e., the claims do not utilize the data generated by the judicial exception to affect any type of change. See MPEP 2106.04(a)(2)(A)(iv). Therefore, the claims do not use the acquired NMR spectrum data, the determined concentration of LP-Z and concentration of total apoB-containing lipoproteins, and the calculated Z index score, and the patient mortality rate, and the abstract ideas to construct a practical application such as treating a subject, transformation of matter, or improving upon an existing technology.
The recited additional element of using computer processes, components, and equipment of claim 1 does not integrate the recited judicial into a practical application because using computers for programmatically [Spec page 60para 0032] determining biomarker concentrations from NMR spectrum data is tangential to the instructions performed. See MPEP 2106.05(b), 2106.05(d), and 2106.05(g).
The additional element of data gathering by acquiring NMR spectrum data from an NMR spectrometer of claim 1 does not does not integrate the recited judicial into a practical application because acquiring NMR data from an NMR spectrometer that is subsequently analyzed by the abstract idea is deemed an extra-solution activity. See MPEP 2106.05(g).
The recited additional element of using NMR spectrometer of claim 13 does not integrate the recited judicial into a practical application because performing clinical test using NMR spectrometer to gather LP-Z biomarker data that is subsequently analyzed by the abstract idea is deemed an extra-solution activity. See MPEP 2106.05(g).
Claim 13 recites placing the bio sample of the subject in an NMR spectrometer. The claimed step is merely an act of placing a sample into a machine (i.e., physical step). Although this step is a physical step, the step does not construct a practical application as placing a sample into a machine is an inherent physical step for gathering NMR spectrum data and analyzing the placed bio sample. See MPEP 2106.05(d)(I) and 2106.05(g).
The additional element of data outputting by producing a report of 14 does not does not integrate the recited judicial into a practical application because outputting data or a report or analysis is an extra-solution activity. See MPEP 2106.05(g).
The additional element of using different samples of claim 15 does not integrate the recited judicial into a practical application because bio samples (i.e., blood, serum, plasma cerebral spinal fluid, and urine are utilized) are utilized as a source of biomarkers (i.e., LP-Z and total apoB-containing lipo-proteins, cell-free nucleic acids) that is subsequently analyzed by a NMR spectrometer.
2B Analysis - Consideration of Additional Elements and Significantly More
The claimed method also recites "additional elements" that are not limitations drawn to an abstract idea.
The recited additional element of using computer processes, components, and equipment of claim 1 does not add significantly more than the recited judicial exception because using computer elements are merely tangential to programmatically determining biomarker concentrations from NMR spectrum data and are deemed well-known and conventional. See MPEP 2106.05(b) and 2106.05(d).
The additional element of data gathering by acquiring NMR spectrum data of claim 1 does not add significantly more than the recited judicial exception because acquiring NMR data from NMR spectrometer that is subsequently analyzed by the abstract by the is deemed a well-known and conventional an extra-solution activity. See MPEP 2106.05(a)(II)(ii), 2106.05(d)(II)(i), and 2106.05(g). To provide evidence of conventionality, Connelly et al. (Connelly) teaches the quantification of abnormal lipoproteins associated with liver disease using nuclear magnetic resonance spectroscopy [title]. Connelly teaches using NMR data in an NMR LipoProfile test for deconvolving LP-X, LP-Y, and LP-Z [II Methods middle col, III Results] (LabCorp Poster: Efficient quantification of abnormal lipoproteins associated with liver disease by nuclear magnetic resonance spectroscopy 2017).
To provide further evidence of conventionality, Freeman et al. (Freeman), teaches deconvolving NMR data [Results C] (Freeman Poster: The Effects of MEDl6012 on Lipoproteins in Familial LCAT Deficiency Patients and a New NMR Method for Quantifying Lipoprotein-X (2017)).
To provide further evidence of conventionality, Kremer et al. (Kremer) disclose a method for determining lipoproteins in body fluid [title]. Kramer discloses using NMR spectra of plasma [Kramer, claims 1-2] (US Patent Application: US 2008/0038829, Patent Pub Date: 14 February 2008).
The recited additional element of using NMR spectrometer of claim 13 does not add significantly more than the recited judicial exception because using NMR spectrometer to gather LP-Z biomarker data that is subsequently analyzed by the abstract is deemed well-known and conventional. See MPEP 2106.05(d)(II)(i) and 2106.05(g). To provide evidence of conventionality, Connelly teaches the quantification of abnormal lipoproteins associated with liver disease using nuclear magnetic resonance spectroscopy [title]. Connelly teaches NMR LipoProfile Test [II. Methods].
To provide further evidence of conventionality, Freeman et al. (Freeman), teaches using NMR spectroscopy for analyzing LP-X and LP-Z using Vantera NMR clinical analyzer [methods].
To provide further evidence of conventionality, Kremer discloses a device comprising NMR spectrometer [Kramer, claim 18].
The additional element of data outputting by producing a report of claim 14 does not add significantly more than the recited judicial exception because outputting data/providing clinical analysis report is a well-known and conventional extra-solution activity. See MPEP 2106.05(g). To provide evidence of conventionality, LabCorp teaches understanding the NMR LipoProfile Test report (LabCorp: understanding the NMR LipoProfile Test (2016)).
The additional element of using different samples of claim 15 does not add significantly more to the recited judicial exception because using bio samples (i.e., blood, serum, plasma cerebral spinal fluid, and urine) to obtain biomarker data that is subsequently analyzed by an abstract idea is deemed well-known, routine and conventional. See MPEP 2106.05(a)(II)(ii), 2106.05(d)(II)(i), and 2106.05(g). To provide evidence of conventionality, Connelly teaches analyzing plasma sample [II Methods].
To provide further evidence of conventionality, Freeman teaches using plasma sample [method].
To provide further evidence of conventionality, Kremer discloses using plasma and serum samples [Kramer, claim 9].
In conclusion and when viewed as a whole, these additional claim element(s) do not provide meaningful limitation(s) to transform the abstract idea recited in the instantly presented claims into a patent eligible application of the abstract idea such that the claim(s) amounts to significantly more than the abstract idea itself. Therefore, the claim(s) are rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 17 March 2026 have been fully considered but the rejection is maintained.
The Applicant traverses the rejection under 35 USC 101. The Applicant points to the steps of the 101 analyses. The Applicant states the amended claims now contains four active steps: "acquiring an NMR spectrum from an NMR spectrophotometer of a bio sample obtained from a subject," "using the NMR spectrum, programmatically determining a concentration of LP-Z and a concentration of total apoB-containing lipoproteins in the bio sample,", "calculating a Z index score based on the concentration of LP-Z and the concentration of total apoB-containing lipoproteins” and “indicating a patient mortality rate based on the Z index score.” The Applicant states the steps of "obtaining" and" determining" recited in currently amended claim 1 involves using an NMR and an NMR spectrum, respectively [remarks, page 6]. The Applicant states acquiring NMR spectrum is not an abstract idea and measuring lipoprotein concentration in a sample with NMR spectrometer and indicating a patient mortality rate using lipoprotein are physical steps, not abstract ideas [remarks, page 7]. The Applicant states the application applies a patient mortality rate from concentrations lipoproteins, which comprises unconventional steps in the field of predicting the risk of AH. The Applicant states the present application improves accuracy and efficiency of the prediction risk. The Applicant disagrees with the Examiners assertion that claim 1 using step can be performed in the human mind. The Applicant further states that acquiring NMR data cannot be performed in the human mind. The Applicant states claim 1 is not directed to any judicial exceptions [remarks, page 7].
In response, the acquiring an NMR spectrum step of claim 1, as noted above in Step 2A Prong II and Step 2B of the 101 analyses, is an additional element (i.e., data gathering element). However, the using the NMR spectrum step reads on abstract idea performed in a computing environment and performed using a computer a tool “programmatically [Spec page 6 para 0032]” to process the abstract ideas. Here, the acquiring the NMR spectrum data encompasses measuring/acquiring NMR spectrum from an NMR spectrophotometer while the subsequent step (i.e., using the NMR spectrum step) processes the acquired data from the NMR spectrophotometer to determine concentrations of lipoproteins. Therefore, the using the NMR spectrum step reads on abstract ideas (i.e., observing, evaluating, and organizing data to determine lipoprotein concentrations). With respect to the claims using unconventional steps and providing improved accuracy and efficiency, improvements to technology are evaluated under Step 2A Prong II of 35 U.S.C § 101 analysis while conventionality is evaluated under Step 2B of the 35 U.S.C § 101 analysis. Therefore, the claims are not patent eligible under Step 2A Prong I of the 35 U.S.C § analysis.
The Applicant points to Step 2A Prong II of the 101 analyses. The Applicant points to the MPEP 2106.04(d) for guidance. The Applicant states claim 1 integrates the recited judicial exception into a practical application. The Applicant further points to the MPEP 2106.04(d)(I) for guidance. The Applicant states the claims provide an improve in the functioning of a computer or an improvement to other technology and applying or using the judicial in a meaningful way beyond generally linking the use of judicial exception to a particular environment. The Applicant states claim 1, as a whole, provides an improvement in a technological field by indicating a patient mortality rate to alcoholic hepatitis (AH). The Applicant points to MPEP 2106.04(d)(I). The Applicant states the claim requires using NMR spectrum data from an NMR spectrophotometer. The Applicant states that claim 1, as a whole, is more than drafting effort design to monopolize the biomolecules recited in the claims. The Applicant states claim 1 should be patent eligible [remarks, page 8].
In response, as noted in Step 2A Prong II of the 101 analyses above, claim 1 does not contain any additional elements that integrate the judicial into a practical application because the acquiring data step is a data gathering element used to acquire NMR spectrum while the additional element of using computer elements to process the additional elements is merely tangential to the claimed method. See MPEP 2106.05(d)(I) and 2106.05(g).
Furthermore, the claims are not drawn to an improvement in a technological field because claim 1 is drawn to gathering and analyzing information (i.e., LP-Z and apoB-containing lipoproteins concentration in a bio sample) using conventional techniques (i.e., well-known laboratory techniques to detect enzymes levels in a bodily sample such as plasma and/or NMR spectrum/spectrum data) and displaying the results (i.e., Z-score based on LP-Z and apoB-containing lipoproteins concentration, producing a report (claim 14) that indicates patient mortality). See MPEP 2106.05(a)(II)(ii-iii). Here, the claims, as a whole, do not integrate the recited judicial exception into a practical application because, as noted in Step 2A Prong II of the 101 analysis above, the claims are entirely drawn to data analysis (i.e., calcualting a Z-score for indicating patient mortality rate using LP-Z and apoB containing lipoproteins concentrations from a bio sample) which can be performed by the human mind or with math, and/or with the aid of a generic computer merely for programming efficiency. The abstract idea (i.e., Z index score for indicating patient mortality rate) and law of nature/natural phenomenon are not applied to any additional elements so as to result in a practical application or an improvement to technology. Additionally, the results of the abstract idea (i.e., Z index score) and the correlation to alcoholic hepatitis are not integrated with any additional elements such that to construct a practical application or provide an improvement to an existing technology. Moreover, the specification does not set forth evidence that the claimed process causes a computer to operate differently than it ordinarily would. Additionally, the claimed elements do not provide a meaningful way beyond generally linking judicial exception to a technological environment because using a machine to collect data (i.e., NMR) and using a computer to process the measured/acquired lipoprotein concentration data (i.e., NMR spectrum data) to output a quantitative/numerical value (i.e., Z index score for indicating patient mortality rate) is just determining biomarker concentrations in a sample to provide input for an equation for indicating patient mortality rate. See MPEP 2106.05(d)(II)(i) and 2106.05(g). Here, the specification discloses the invention can provide am improved prognostic method [page 2 para 0007] and accurately detect and quantify LP-Z [page 2 para 0007-0008, page 5 para 0025]. However, the evidence disclosed in the specification regarding providing an efficient and accurate predict risk is conclusory (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art). See MPEP 2106.04(d)(I) (second paragraph). Also, it appears that claim 1 is drawn to a process of using a computer “programmatically [Spec page 6 para 0032]” for calculating Z-index score for indicating patient mortality. However, the computer is also not improved by way to the claimed process. Thus, under Step 2A Prong II of the 101 analyses, the claims do not provide a practical application or an improvement to an existing technology. Therefore, the claims are not patent eligible.
The Applicant points to MPEP 2106.04(d) and 2106.05(II) for further guidance. The Applicant points to Step B of the 101 analyses. The Applicant states claim 1 was found to be free of the art and submits claim 1 results in a method that is not well-understood, not routine, and unconventional. The Applicant points to the conventionality references and states the methods of the conventionality references do not teach or discloses using a Z-score to predict patient immortality is not conventional [remarks, pages 9-10].
In response, and as noted above, the additional elements contained in the claim set are well-known and conventional. With respect to the references not disclosing or teaching abstract ideas (i.e., indicating patient mortality, suggesting a Z index), abstract ideas are evaluated in Step 2A Prong I of the 101 analysis. Thus, although the references do not teach/disclose a Z index score with respect to alcoholic hepatitis (AH), the references do teach/disclose the conventionality of the additional elements of the claimed invention.
Furthermore, with respect to the claimed steps being free of the art, the argument is not persuasive because as described in the MPEP 2106.05(I) states “Although the courts often evaluate considerations such as the conventionality of an additional element in the eligibility analysis, the search for an inventive concept should not be confused with a novelty or non-obviousness determination. See Mayo, 566 U.S. at 91, 101 USPQ2d at 1973. As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp.,” The MPEP further states “the search for a 101 inventive concept is thus distinct from demonstrating § 102 novelty."). In addition, the search for an inventive concept is different from an obviousness analysis under 35 U.S.C § 103”. Specifically, lack of novelty under 35 U.S.C § 102 or obviousness under 35 U.S.C § 103 of a claimed invention does not necessarily indicate that additional elements are well-understood, routine, conventional elements. Because they are separate and distinct requirements from eligibility, patentability of the claimed invention under 35 U.S.C § 102 and 103 with respect to the prior art is neither required for, nor a guarantee of, patent eligibility under 35 U.S.C § 101. The distinction between eligibility (under 35 U.S.C § 101) and patentability over the art (under 35 U.S.C § 102 or 103) is further discussed in MPEP § 2106.05 (d).
Thus, although claim 1 is free of the art, claim 1 encompasses using conventional data gathering element(s) for obtaining data (i.e., acquiring NMR spectrum data) and analyzing the NMR spectrum data for determining concentrations of biomarkers (i.e., LP-Z and apoB-containing lipoproteins concentration in a bio sample) for subsequently performing computations/solving equations (i.e., calculating a Z-score for indicating patient mortality rate) which is conventional. See MPEP 2106.05(g). Here, claim 1 is drawn to performing clinical testing (i.e., NMR spectrometer) on patient provided bio sample(s) to obtain input (i.e., NMR spectrum data containing LP-Z and apoB-containing lipoproteins levels/concentrations) for an equation (i.e., Z-score for indicating a patient mortality rate). Additionally, the claims are drawn to determining a level of biomarker in the blood by any means (i.e., using NMR spectrometer) which is well-understood, routine, and conventional. See MPEP 2106.05(II)(ii) and 2106.05(d)(II)(i). Furthermore, as described by the MPEP 2106.05(g), performing clinical tests (i.e., using NMR spectrometer) to obtained data to calculate a Z-index score based on the concentration of LP-Z and the concentration of total apoB-containing lipoproteins in the bio-sample is an insignificant extra-solution activity. Additionally, the claims are drawn to gathering and analyzing information (i.e., lipoprotein concentrations) using conventional techniques (i.e., NMR spectrometer) and displaying the result (i.e., an indication indicating patient mortality rate to alcoholic hepatitis) which does not provide significantly more. See MPEP 2106.05(a)(II) (ii-iii). Thus, under the 2B Analysis, the claims, as a whole, do not add significantly more than the recited judicial exception. Therefore, the claims are not patent eligible under 35 U.S.C § 101.
Double Patenting
The rejection of claims 1-7, 9, 13, and 15 on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent No. Otvos et al. (U.S Patent 11,467,171) in the Office Action mailed 17 December 2025 is withdrawn in view of the amendments received 17 March 2026.
Conclusion
Claim 1-15 are rejected.
No claims are allowed.
Finality
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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH C PULLIAM whose telephone number is (571)272-8696. The examiner can normally be reached 0730-1700 M-F.
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/J.C.P./ Examiner, Art Unit 1687
/Anna Skibinsky/
Primary Examiner, AU 1635
Prosecution Insights