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 .
Claim Status
Claims 1-10 are currently pending and under examination herein.
Claims 1-10 are rejected.
Claim 5 is objected to.
Priority
The instant application claims no priority. Therefore, the effective filing date is 10 October 2023 for claims 1-10.
Information Disclosure Statement
No information disclosure statement (IDS) is found amongst the submitted documents.
Drawings
The drawing filed 10 October 2023 are accepted.
Claim Objections
Claim 5 is objected to because it recites B and β to refer to the numbered coefficients. Please select one style for naming the coefficients.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
Claim 1 is rejected under 35 U.S.C. 112(b) as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim (see MPEP 2173.05(r)).
Claim 2 recites the limitation "the levels" and “as determined from a sample of a patient” after “assign a patient to a group”. It is unclear if there is 1 or more than 1 patient being tested. If there is only one patient, the second use should be “the patient”, which would be consistent with “the levels”. If there are multiple patients, they need different designations. Claims 3-10 depend on Claim 2, and thus contain the above issues due to said dependence.
Claim 5 recites “the subject”. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the subject is the same as the patient. The metes and bounds are therefore unclear rendering the claim indefinite. Claim 7 depends on Claim 5, and thus contain the above issues due to said dependence.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 5 recites broad recitation ranges of “comprised between” (for B0, B1, B2, B3, and B5) and the claim also recites “in particular” (for B0, B1, B2, B3, and B5) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Claim 7 depends on Claim 5, and thus contain the above issues due to said dependence.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 1 recites an “invention” as part of an omnibus claim (See 35 USC 112(b) rejection above). It is not clear which of the statutory categories the term invention corresponds to.
Claim 2-8 does not fall within at least one of the four categories of patent eligible subject matter because it recites a computer program executed by a processor. Products that do not have a physical or tangible form, such as information (often referred to as "data per se") or a computer program per se (often referred to as "software per se") when claimed as a product without any structural recitations are not directed to any of the statutory categories (MPEP 2106.03). This rejection can be overcome by having the program code stored on memory and executed by the processor (although then it could repeat claim 9).
Claim 9 recites “A computer readable medium” executed by a processor. The claims and specification does not explicitly define the computer readable medium as non-transitory. Transitory forms of signal transmission (often referred to as "signals per se"). The interpretation for transitory computer-readable medium encompasses signals per se (see MPEP 2106.03). Therefore, the claim is not directed to a statutory category. This rejection can be overcome by specifying the CRM is non-transitory.
Claims 2-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea and a natural law without significantly more. In accordance with MPEP § 2106, claims found to recite statutory subject matter (Step 1: YES) are then analyzed to determine if the claims recite any concepts that equate to an abstract idea or natural law (Step 2A, Prong 1). Claim 10 is directed to a system. While claims 2-9 are not directed to a statutory category of invention (see above), they are included in the subject matter eligibility analysis to facilitate compact prosecution. In the instant application, the claims recite the following limitations that equate to an abstract idea or natural law:
Claim 2 recites the limitation - analyze the levels of the markers, the age and the gender of the patient; and based on said analysis, assign the patient to a group of MASH patients eligible to liver biopsy or to a group of patients not eligible to liver biopsy. Based on the broadest reasonable interpretation, analyzing the values and information and assigning a group based on the analysis encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea. Additionally, assigning the patient to a group based on said analysis is interpreted as identifying if a patient has a disease based on biomarkers. This draws the limitation to a natural correlation, which classifies the limitation as a law of nature.
Claim 3 recites the limitation - calculating a first score from the levels of ALAT, ASAT, Platelets and the age; calculating a second score from the levels of hsa-miR-34a-5p and YKL-40 and the gender; comparing the calculated first score to a first cutoff value; and comparing the calculated second score to a second cutoff value. Based on the broadest reasonable interpretation, calculating and comparing values encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 4 recites the limitation - wherein the first score (S1) is calculated with the following mathematical function: S1=age (years)×ASAT (U/L)/platelet (×109/L)/√ALAT (U/L). Based on the broadest reasonable interpretation, calculating values encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 5 recites the limitation - wherein the second score (S2) is calculated with the following logistic function (S2), wherein equation for y, wherein Gender is 0 if the subject is a female, or 1 if the subject is a male; B0 is comprised between −3 and 3, in particular between −2 and 2; B1 is comprised between 1 and 5, in particular between 2 and 4; B2 is comprised between 0 and 4.5, in particular between 0.5 and 3; B3 is comprised between −2 and 2, in particular between −1 and 1; and B4 is comprised between −1 and 2, in particular between 0 and 2. Based on the broadest reasonable interpretation, calculating values encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 6 recites the limitation - wherein the first cutoff is comprised between 2 and 3. This limitation specifies the values compared in the judicial exception of claim 3. The refined limitation indicated still represents a judicial expectation.
Claim 7 recites the limitation - wherein the second cutoff is comprised between 0.4 and 0.8. This limitation specifies the values compared in the judicial exception of claim 3. The refined limitation indicated still represents a judicial expectation.
Claim 8 recites the limitation - assign the patient to a group of patients eligible to liver biopsy if the first score is lower than the first cutoff value and the second score is higher than the second cutoff value; or assign the patient to a group of patients not eligible to liver biopsy if the first score is higher than the first cutoff value or the second score is lower than the second cutoff value. Based on the broadest reasonable interpretation, assigning a group by comparing values encompasses equations and could practically be done by the human mind. This draws the limitation to a mathematical concept and a mental process, which classifies the limitation as an abstract idea.
Claim 9 recites the limitation - the computer program according to claim 2. This recites the judicial exceptions of claim 2 (see above).
Claim 10 recites the limitation - the computer program according to claim 2. This recites the judicial exceptions of claim 2 (see above).
These limitations recite concepts of calculating and determining information and values that are so generically recited that they can be practically performed in the human mind as claimed, which falls under the “Mental processes” and “Mathematical concepts” grouping of abstract ideas. A mathematical concept need not be expressed in mathematical symbols, because words used in a claim operating on data to solve a problem can serve the same purpose as a formula (MPEP 2106.04(a)(2)). Additionally, both product claims and process claims may recite mental processes, which can include a claim that requires a computer (MPEP 2106.04(a)(2)). Therefore, these limitations fall under the “Mental process” and “Mathematical concepts” groupings of abstract ideas. Additionally, the limitations describe natural correlations between biomarkers and a disease, which fall under natural laws. This is similar to a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk (Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017)) that the courts have identified as a law of nature. As such, claims 2-10 recite an abstract idea and law of nature (Step 2A, Prong 1: YES).
Claims found to recite a judicial exception under Step 2A, Prong 1 are then further analyzed to determine if the claims as a whole integrate the recited judicial exception into a practical application or not (Step 2A, Prong 2). These judicial exceptions are not integrated into a practical application because the claims do not recite an additional element that reflects an improvement to technology (MPEP 2106.04(d)(1)) or particular treatment (MPEP 2106.04(d)(2)). Rather, the claims provide insignificant extra-solution activity (MPEP § 2106.05(g)) and provide mere instructions to apply a judicial exception (MPEP § 2106.05(f)). Specifically, the claims recite the following additional elements:
Claim 1 recites computer program comprising instructions executed by a central processing unit (CPU); obtain the levels of ALAT, ASAT, platelets, hsa-miR-34a-5p and YKL-40, as determined from a sample of a patient; and obtain the age and the gender of the patient.
Claim 9 recites computer readable medium.
Claim 10 recites a digital computer; a database; at least one central processing unit; and a memory.
There are no limitations that indicate that the claimed calculating and determining information and values require anything other than generic computing systems. As such, these limitations equate to mere instructions to implement the abstract idea on a generic computer that the courts have stated does not render an abstract idea eligible. There is no indication that these steps are affected by the judicial exception in any way and thus do not integrate the recited judicial exception into a practical application. As such, claims 2-10 are directed to an abstract idea and natural law (Step 2A, Prong 2: NO).
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself (Step 2B). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite conventional additional elements that equate to mere instructions to apply the recited exception in a generic way or in a generic computing environment. The claims also recite conventional additional elements that represent insignificant extra-solution activities.
As discussed above, there are no additional limitations to indicate that the claimed calculating and determining information and values require anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea or natural law using a generic computer do not render an abstract idea or natural law eligible. MPEP 2106.05(f) discloses that mere instructions to apply the judicial exception cannot provide an inventive concept to the claims. As specified in MPEP 2106.05(g), extra-solution activities can be understood as incidental to the primary process or product that are merely a nominal or tangential addition to the claim. Insignificant extra-solution activities include mere data gathering, selecting a particular data source or type of data to be manipulated, and displaying information. Additionally, Heyens et al. (2021, Frontiers in Medicine, Vol. 8: 1-20) indicate the collection and use of data, including levels of ALAT, ASAT, platelets, hsa-miR-34a-5p, YKL-40, patient age, and gender, are well understood routine and conventional (Page 10, Column 1, Paragraph 1: This index is composed of routinely available laboratory data (AST, alanine aminotransferase (ALT) and platelets); Page 10, Column 2, Paragraph 1: The NIS4 panel comprised of the following NASH-associated biomarkers: miR-34a-5p, YKL-40. NIS4 algorithm experiences no influence of age, sex, BMI, or liver enzyme concentrations).
The additional elements do not comprise an inventive concept when considered individually or as an ordered combination that transforms the claimed judicial exception into a patent-eligible application of the judicial exception. Therefore, the claims do not amount to significantly more than the judicial exception itself (Step 2B: No). As such, Claims 2-10 are not patent eligible in relation to subject matter eligibility.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Hanf et al. (WO 2019038456 A1), in view of Brozek (WO 2020182952 A1). Italicized text from reference art.
Applicable Claims Include:
Claim 2. A computer program comprising instructions that, when executed by a central processing unit (CPU), cause the central processing unit to assign a patient to a group of MASH patients eligible or not eligible to liver biopsy, wherein the program cause the CPU to: (Claim 2.i) obtain the levels of ALAT, ASAT, platelets, hsa-miR-34a-5p and YKL-40, as determined from a sample of a patient; (Claim 2.ii) obtain the age and the gender of the patient; (Claim 2.iii) analyze the levels of the markers, the age and the gender of the patient; and (Claim 2.iv) based on said analysis, assign the patient to a group of MASH patients eligible to liver biopsy or to a group of patients not eligible to liver biopsy.
Claim 9. A computer readable medium comprising the computer program according to claim 2.
Claim 10. A system for patient classification, for use in determining whether said patient is eligible to liver biopsy with the aid of a digital computer, said system comprising: a database; at least one central processing unit; and a memory comprising the computer program according to claim 2.
Regarding Claims 2, 9, and 10, Hanf et al. teach (Claim 2.i) obtain the levels of ALAT, ASAT, platelets, hsa-miR-34a-5p and YKL-40, as determined from a sample of a patient (Page 8, Line 15: the method comprising determining the level of miR-193 and of at least one marker selected in the group consisting of YKL-40; Page 57, Line 13: HEMATOLOGY includes platelet count; Page 57, Line 17: BIOCHEMISTRY Panel I includes aspartate aminotransferase (AST), alanine aminotransferase (ALT); Page 60, Line 30, table: hsa-miR-193b-5p). Hanf et al. also teach using miR-34a biomarkers (Page 34, Line 19: illustrative additional microRNAs that may be useful in the practice of the present invention include: miR-34a). Hanf et al. teach (Claim 2.ii) obtain the age and the gender of the patient (Page 62, Line 9: demographic (age, sex). Hanf et al. teach (Claim 2.iii) analyze the levels of the markers, the age and the gender of the patient (Page 32, Line 7: NAFLD, NASH or liver fibrosis subject, and/or for the classification of a subject as a potential responder or non-responder to a medical treatment, and/or for the prediction of disease outcome for a subject, the measure of miR-193 level can be introduced in mathematical models (algorithms) for combination with other variables such as sex, age, body mass index, weight, medical status, arterial pressure or other body fluid markers such as blood, serum or plasma circulating markers, notably those mentioned in the following table (see the table on page 32, Line 15)). Hanf et al. teach (Claim 2.iv) based on said analysis, assign the patient to a group of MASH patients eligible to liver biopsy or to a group of patients not eligible to liver biopsy (Page 32, Line 4: diagnosing NASH). This limitation is interpreted as equivalent diagnosing NASH (i.e. a patient would only need a biopsy if the analysis determined they were suspected of having MASH/NASH) (Page 55, Line 37: Liver biopsy was performed to confirm the diagnosis of NASH). Additionally, Hanf et al. teach the methods are carried out by a computer, which inherently contains program code, memory, including computer readable storage, and at least one processor, to execute the steps of the method (Page 60, Line 7: Limma, an R/Bioconductor software package, powered differential analyses for HTG Edge sequencing analyses). Additionally, the use of stored values within a computer system is interpreted and the inclusion of a database within the system. Claims 9 and 10 recites the limitations of claim 2 directed a computer readable medium and computer to perform the functions of claim 2.
Hanf et al. does not explicitly teach hsa-miR-34a-5p (Claims 2, and 9, and 10).
Regarding Claim 2, 9, and 10, Brozek teaches (Claim 2.i) measuring (Page 22, Line 34: Quantitative RTqPCR of miR-34a-5p in Serum) and its use in calculations (Page 7, Line 5: A is the serum level of hsa-miR-34a-5p).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine Brozek with Hanf et al. Brozek teach their novel methods resulted in improved NASH detection (Page 26, Line 24: Combination of FIBROSCAN® and NIS4 individual variables to improve advanced NASH detection. A new step wise modeling by logistic regression was performed using hsa-miR-34a-5p), which is a major focus of Hanf et al. and the instant application. Furthermore, one of ordinary skill in the art would predict that the methods could be readily combined with a reasonable expectation of success because both are within the same technical field – using calculations of biomarkers and patient information to assess NASH/MASH.
Claims 2-10 are rejected under 35 U.S.C. 103 as being unpatentable over Hanf et al., as applied to Claims 2, 9 and 10 above, in view of Brozek, as applied to Claims 2, 9 and 10 above, and in further view of Powell et al. (2021, Lancet, Vol. 397: 2212-2224). Italicized text from reference art.
Applicable Claims Include:
Claim 2, 9, and 10 are presented above.
Claim 3. The computer program according to claim 2, wherein the analysis made by the central processing unit comprises: (Claim 3.i) calculating a first score from the levels of ALAT, ASAT, Platelets and the age; (Claim 3.ii) calculating a second score from the levels of hsa-miR-34a-5p and YKL-40 and the gender; (Claim 3.iii) comparing the calculated first score to a first cutoff value; and (Claim 3.iv) comparing the calculated second score to a second cutoff value.
Claim 4. The computer program according to claim 3, wherein the first score (S1) is calculated with the following mathematical function: S1=age (years)×ASAT (U/L)/platelet (×109/L)/√ALAT (U/L).
Claim 5. The computer program according to claim 3, wherein the second score (S2) is calculated with the following logistic function:
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Wherein Gender is 0 if the subject is a female, or 1 if the subject is a male; B0 is comprised between −3 and 3, in particular between −2 and 2; B1 is comprised between 1 and 5, in particular between 2 and 4; B2 is comprised between 0 and 4.5, in particular between 0.5 and 3; B3 is comprised between −2 and 2, in particular between −1 and 1; and B4 is comprised between −1 and 2, in particular between 0 and 2.
Claim 6. The computer program according to claim 4, wherein the first cutoff is comprised between 2 and 3.
Claim 7. The computer program according to claim 5, wherein the second cutoff is comprised between 0.4 and 0.8.
Claim 8. The computer program according to claim 3, wherein the computer program causes the central processing unit to: assign the patient to a group of patients eligible to liver biopsy if the first score is lower than the first cutoff value and the second score is higher than the second cutoff value; or assign the patient to a group of patients not eligible to liver biopsy if the first score is higher than the first cutoff value or the second score is lower than the second cutoff value.
Regarding Claims 2, 9 and 10, these limitations are taught by Hanf et al. and Brozek as indicated above.
Regarding Claim 3, Hanf et al. teach (Claim 3.i) calculating a first score from the levels of ALAT, ASAT, Platelets and the age (Page 34, Line 4: the FIB4 index). Hanf et al. teach (Claim 3.ii) calculating a second score from the levels of hsa-miR-34a-5p and YKL-40 and the gender (Page 35, Line 28: the NASH score S1 is defined as a logistic function. A is the level of hsa-miR-193b-3p. C is the level of YKL-40; Page 32, Line 9: the measure of miR-193 level can be introduced in mathematical models (algorithms) for combination with other variables such as sex; Page 62, Line 6: explicative variables encompassed a wide range of biomarkers measured in blood as long as demographic (sex)). Hanf et al. suggest swapping hsa-miR-193b-3p with other biomarkers (Page 35, Line 25: the method of the invention may be used to calculate a score, or NASH-score, from the levels of the biomarkers whose levels have been measured). Hanf et al. teach (Claim 3.iv) comparing the calculated second score to a second cutoff value (Page 8, Line 31: comparing the score to a cut-off value in order to determine the risk of NASH progression in the subject).
Regarding Claim 5, the second score (S2) is calculated with the logistic function (Page 35, Line 28: the NASH score S1 is defined as a logistic function). The equations are equivalent because e^-y = 1/e^y ( and multiplied by e^y/e^y). See above for teachings and obviousness of including the biomarker and gender parameters within the logistic equation.
Regarding Claim 7, Hanf et al. teach the second cutoff is comprised between 0.4 and 0.8 (Page 36, Line 15: The NASH score is thus the probability of having a moderate to high NASH activity or a severe NASH; Page 36, Line 34: wherein the threshold value is comprised between 0.3050 and 0.6518).
Regarding Claim 8, Hanf et al. teach assign the patient to a group of patients eligible to liver biopsy if the first score is lower than the first cutoff value and the second score is higher than the second cutoff value; or assign the patient to a group of patients not eligible to liver biopsy if the first score is higher than the first cutoff value or the second score is lower than the second cutoff value. Each limitation is considered a contingent limitation which indicates the broadest reasonable interpretation of a method (or process) claim requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04). Additionally, this is obvious over the teachings of Powell et al. and Hanf et al. in regard to the thresholds above because a patient would only be biopsied for NASH if the result of the calculations indicated low fibrosis and high NASH.
Hanf et al. do not explicitly teach comparing the calculated first score to a first cutoff value (Claim 3.iii). Hanf et al. do not explicitly teach the equation of the first score (Claim 4). Hanf et al. do not explicitly teach the values of the first cutoff (Claim 6).
Regarding Claim 3, Powell et al. teach the FIB4 index is a score of the levels of ALAT, ASAT, Platelets and the age as evidenced by (Page 2216, Panel: Fibrosis-4 Index for liver fibrosis). Powell et al. teach (Claim 3.iii) comparing the calculated first score to a first cutoff value (Page 2216, Panel: Patients at low risk of advanced fibrosis have an index of less than 1·3 (age <65 years) or less than 2·0 (age ≥65 years); a score greater than 3·25 is suggestive of advanced fibrosis).
Regarding Claim 4, Powell et al. teach the first score (S1) is calculated with the following mathematical function: S1=age (years)×ASAT (U/L)/platelet (×109/L)/√ALAT (U/L) (Page 2216, Panel: Fibrosis-4 Index for liver fibrosis (the equations are equivalent)).
Regarding Claim 6, Powell et al. teach the first cutoff is comprised between 2 and 3 (Page 2216, Panel: Patients at low risk of advanced fibrosis have an index of less than 1·3 (age <65 years) or less than 2·0 (age ≥65 years); a score greater than 3·25 is suggestive of advanced fibrosis).
Regarding Claim 8, Powell et al. teach assign the patient to a group of patients eligible to liver biopsy if the first score is lower than the first cutoff value and the second score is higher than the second cutoff value; or assign the patient to a group of patients not eligible to liver biopsy if the first score is higher than the first cutoff value or the second score is lower than the second cutoff value. Each limitation is considered a contingent limitation which indicates the broadest reasonable interpretation of a method (or process) claim requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met (MPEP 2111.04). Additionally, this is obvious over the teachings of Powell et al. and Hanf et al. in regard to the thresholds above because a patient would only be biopsied for NASH if the result of the calculations indicated low fibrosis and high NASH.
Regarding Claim 3, Brozek teaches (Claim 3.ii) calculating the score with miR-34a-5p (Page 7, Line 5: A is the serum level of hsa-miR-34a-5p), which is also obvious given the teaching of Hanf et al. in claim 2.
Regarding Claim 5, Brozek teaches the same equation and similar use of parameters as Hanf et al. (page 9, line 36).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine Powell et al. with Brozek and Hanf et al. Powell et al. teach specific and important calculations and analysis techniques to be applied to assessing NASH (Page 2, Column 2, Paragraph 1: As understanding the pathogenesis of NAFLD and NAFLD related fibrosis is vital in the development of biomarkers for its diagnosis and in finding targets for its treatment, we first review the most important aspects of NAFLD-related fibrogenesis), which is a major focus of Hanf et al., Brozek, and the instant application. Furthermore, one of ordinary skill in the art would predict that the methods could be readily combined with a reasonable expectation of success because all are within the same technical field – using calculations of biomarkers and patient information to assess NASH/MASH.
Double Patenting
No double patenting issues.
Conclusion
No Claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BLAKE H ELKINS whose telephone number is (571)272-2649. The examiner can normally be reached Monday-Friday 8-5PM.
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/B.H.E./Examiner, Art Unit 1687
/Karlheinz R. Skowronek/Supervisory Patent Examiner, Art Unit 1687
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