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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 31 August 2026 has been entered.
Status of the Claims
Claim set entered 31 August 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Claims 16-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06 January 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 101
The instant rejection is maintained for reason for record in the Office Action mailed 02 June 2026 and modified in view of the amendments filed 31 August 2026.
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 acquired 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)(I)(A)(iv). Thus, because judicial exception of the claims, alone, is not eligible subject matter and the claims do not encompass any additional elements other than of extra-solution activities (i.e., NMR spectrophotometer for acquiring NMR data) and tangential computer elements (i.e., programmatically), the claims do not construct a practical application and/or improvement to technology as enumerated below. See MPEP 2106.04(d). Thus, the claims, under Step 2A Prong II of the 101 analyses, are not patent ineligible.
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 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 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.
This judicial exception is not integrated into a practical application because the claims do not meet any of the following criteria:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
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 31 August 2026 have been fully considered but the rejection is maintained.
The Applicant provides the limitations of claim 1 [remarks, page 6]. The Applicant states the human mind cannot acquire an NMR spectrum from NMR spectrophotometer using the human mind. The Applicant states that acquiring NMR spectrum is a physical process [remarks, page 6].
It is noted, under Step 2A Prong II and Step 2B acquiring NMR spectrum data using an NMR spectrophotometer reads on an additional element that provides data that is subsequently processed by the abstract ideas (i.e., determining a concentration for calculating a score) in a computing environment [Spec [0032] The term "programmatically" means carried out using computer program and/or software, processor or ASIC directed operations. Here, " ’programmatically’ determining concentration…” refers to using a computer for determining concentrations using NMR spectrum which reads on abstract ideas (i.e., determining concentration) performed in the computing environment. See MPEP 2106.04(a)(2)(III)(C)(1-3).
The Applicant states the Examiner is incorrect in that claim 1 does not recite any additional elements that integrate the judicial exception into a practical application [remarks, page 6]. The Applicant states the Examiner is incorrect that claims are drawn to determining biomarkers in blood by any means. The Applicant states claim 1 plainly recites acquiring an NMR spectrum from an NMR spectrophotometer of a bio sample obtained from a subject and using the acquired NMR spectrum to determine concentrations of LP-Zand the total apoB-containing lipoproteins in the bio sample. The Applicant states an NMR spectrum cannot be obtained using the human mind. Acquiring an NMR spectrum is a physical process that requires the use of an NMR spectrophotometer and immersing the sample in a magnetic field and bombarding the sample with radio waves remarks [remarks, pages 6-7].
In response, and as noted in Step 2A Prong II and Step 2B of the 101 analyses above, acquiring data using an NMR spectrometer is deemed an extra-solution activity (2A Prong II) and is also deemed a routine and conventional extra-solution activity (2B) for gathering NMR spectrum data. Furthermore, using the acquired NMR spectrum for programmatically determining concentrations of LP-Z and the total apoB-containing lipoproteins, as noted above in Step 2A Prong I of the above 101 analyses, reads on abstract ideas (i.e., observing, evaluating, and organizing data (i.e., NMR spectrum data of a bio sample)) for determining a concentration of LP-Z and a concentration of total apoB-containing lipoproteins). Also, and as noted in the Specification [0032], the “determining concentrations” reads on abstract ideas performed in a computing environment. See Specification [0032] and MPEP 2106.04(a)(2)(III)(C)(1-3).
The Applicant states the Examiner overlooked the improvement the Z-index score provides to the care of alcoholic patient [remarks, page 7]. The Applicant points to the Figures 5-6 for guidance. The Applicant states the claim incorporates the use of an NMR spectrophotometer that can be used to practically monitor treatment of AH patients, thereby integrating the judicial exception into a practical application [remarks, pages 7-8]. The Applicant states the Examiner deemed the step of acquiring to be an extra-solution. The Applicant points to the MPEP 2106.05(g) and In re Grams for guidance. The Applicant states with respect to In re Grams, the Applicant states the Specification describes the method for NMR analysis of LP-Z and does not extend the analysis to other complex systems [remarks, page 8].
In response, as noted in Step 2A Prong I of the 101 analyses above, and with respect to the Z-score providing an improvement to technology, the argument is not persuasive because the Z-score reads on abstract ideas. Here, the judicial exception (i.e., Z-score for indicating mortality rate) is quantitative data which is abstract. As such, and as noted in Step 2A Prong II of the above 101 analyses, because judicial exception of the claims, alone, is not eligible subject matter and the claims do not encompass any additional elements other than of extra-solution activities (i.e., NMR spectrophotometer for acquiring NMR data) and tangential computer elements (i.e., programmatically), the claims do not construct a practical application and/or provide an improvement to technology as enumerated MPEP 2106.05(I)(A). Therefore, the claims, under Step 2A Prong II of the 101 analyses, are not patent ineligible.
The Applicant disagrees with the Examiners analysis under 2B [remarks, page 9]. The Applicant points to the Examiner’s conventionality references Connelly, Freeman, and Kramer for guidance. The Applicant states claim 1 is drawn to calculating a Z-score based on biomarker concentrations (i.e., LP-Z and the concentration of total apoB-containing lipoproteins), not merely the determination of lipoproteins. The Applicant points to the specification and MPEP 2106.05(d) for further guidance. The Applicant states the claimed method can be used to practically monitor treatment of AH patients and aid in identifying AH patients that would be candidates for organ transplantation [remarks, page 9].
In response, as noted above in Step 2B of the 101 analyses, the additional elements of the claims are conventional and extra-solution activities. Additionally, claim 1 does not recite limitations for monitoring AH treatments for patients and/or identifying patients for organ transplantation. It is noted that practical applicability is not evaluated under Step 2B of the 101 analyses, and as explained above, because the judicial exception, alone, is not eligible subject matter and the lack of additional elements in claim 1, claim 1 is drawn to mere data analysis which is abstract and insufficient to be patent eligible.
The Applicant states claim 1 satisfies 35 U.S.C § 101. The Applicants states claim 1 does not contain a judicial exception and should not proceed past Step 2A Prong I of the 101 analyses [remarks, page 9]. The Applicant states under Step 2A Prong II, the claims encompass a practical application (i.e., applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception)/improvement to technology [remarks, page 10].
The Applicant states the claims, as a whole, effects the improvements to a technological field. The Applicant states that the combination of the acquiring NMR for determining biomarker concentrations (i.e., LP-Z and total apoB-containing lipoproteins) using an NMR spectrophotometer and computer elements for programmatically for determining biomarker concentrations (i.e., LP-Z and total apoB-containing lipoproteins) using the previous acquired NMR spectrum data to calculate a Z-sore for indicating a patient mortality results in a method that is other than what was well-understood, routine and conventional in the field of the present application at its priority date- the "inventive concept" referred to in MPEP 2106.05 that additionally aids providers in predicting outcome among AH patients with liver failure and identifying AH patients that would be candidates for organ transplantation [remarks, page 10].
In response, and as explained above, under Step 2A Prong I, claim 1 is drawn to processing NMR spectrum data for calcualting a Z-score indicating patient mortality rate which reads on data analysis/abstract ideas.
Under Step 2A Prong II of the 101 analysis, and with respect to the claims providing an improvement to technology and applying the judicial exception in a meaningful way beyond generally linking the use of the judicial exception to a particular technology environment, the argument is not persuasive because the claims are drawn to abstract ideas alone without any additional elements, (i.e., indication of patient mortality) “data analysis” which does not provide a practical application of the judicial exception, provide an improvement to technology, or apply the exception in a meaningful way because the claims are drawn to abstract data analysis alone without any additional elements other than extra solution data gathering activities and tangential computer elements which is insufficient to provide a practical application and/or an improvement to technology.
Under Step 2B of the 101 analyses, the claims do not provide an unconventional combination of additional elements resulting in a method that is other than what was well-understood, routine and conventional in the art at the time of filing because the claims do not utilize any additional elements other than conventional data gathering elements, computer elements, and bio samples. Claim 1 is drawn to abstract data analysis that utilizes a conventional and well-known order of steps for processing biomarker (i.e., LP-Z and total apoB-containing lipoproteins) for obtaining input for an equation. See MPEP 2106.05(g). 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). 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.
Conclusion
Claim 1-15 are rejected.
No claims are allowed.
Finality
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this 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.
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, Karlheinz Skowronek can be reached at (571) 272-9047. 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.
/J.C.P./ Examiner, Art Unit 1687
/Anna Skibinsky/
Primary Examiner, AU 1635
