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 .
DETAILED ACTION
Response to Amendment
In the Amendment dated 21 January 2026, the following occurred:
Claims 1, 5-9, 15, and 16 were amended.
Claims 14, 18, and 19 were canceled.
Claims 20-23 were added.
Claims 1-13, 15-17, and 20-23 are pending.
Claim Objections
Claim 5 is objected to because of the following informalities:
In claim 5, line 1-4, “wherein each of the one or more reference patients in the reference dataset has a prior history of renal disease based on determining an estimated Glomerular Filtration Rate value (eGFR) or creatinine value,” should read “determining one or more reference patients have a prior history of renal disease based on an estimated Glomerular Filtration Rate value (eGFR) or creatinine value.”
Appropriate corrections are required.
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 1-13, 15-17, and 20-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1, 15, and 16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite a method, computer-readable medium, and computing device for determining a risk, probability, and/or likelihood of a major adverse cardiovascular event (MACE) in a patient, and therefore meet step 1.
Step 2A1
The limitations of (Claim 1 being representative) (a) receiving… subject value data for the patient, the subject value data including (i) at least one troponin value, (ii) at least one demographic value, and (iii) a value for prior history of cardiac disease; (b) determining a reference dataset based on the subject value data for the patient, wherein the reference dataset comprises reference subject values associated with one or more reference patients, wherein the reference subject values include, for each one of the one or more reference patients: (i) at least one troponin value, (ii) at least one demographic value, and (iii) a value for prior history of cardiac disease; (c) evaluating… the received subject value data of the patient based on the reference dataset; and (d) determining the risk of MACE based on the evaluation from step (c), as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions).
That is, other than reciting a method implemented by a general-purpose computing device, the claimed invention amounts to managing personal behavior or interaction between people (i.e., a series of rules or instructions for a person or persons to follow). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of (Claims 1 and 16) a computing device and (Claim 15) a computer-readable medium that implements the identified abstract idea. The computing elements are not exclusively described by the applicant and are recited at a high-level of generality (i.e., the computing device may include one or more processors and at least one data storage, see, e.g., Para. 0130, 0134) such that it amounts to no more than mere instructions to apply the exception using generic computer components. See MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Further, receiving subject value data is considered insignificant extra solution activity such as pre-solution activity e.g., data gathering (performed by receiving/ transmitting/ etc.) See MPEP 2106.05(g).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computing device and a computer-readable medium to perform the noted steps amounts to no more than mere instructions to apply the exception using generic computer components and cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Claims 2-13, 17, and 20-23 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide an inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claims 2, 3, 10, and 17 merely describe the subject value data and the reference subject values, which further defines the abstract idea.
Claim 4 merely describes the reference dataset, which further defines the abstract idea.
Claim 5 merely describes determining one or more reference patients have a prior history of renal disease, which further defines the abstract idea.
Claim 6 merely describes processing historic patient data and determining the patient has a prior history of renal disease, which further defines the abstract idea.
Claims 7 and 8 merely describe a threshold, which further defines the abstract idea.
Claim 9 merely describes processing historic patient data and determining the patient has a prior history of cardiac disease, which further defines the abstract idea.
Claim 11 merely describes the at least one demographic value, which further defines the abstract idea.
Claim 12 merely describes determining a gender, classifying the patient, and selecting the reference dataset, which further defines the abstract idea.
Claim 13 merely describes receiving further subject value data and evaluating the further subject value data, which further defines the abstract idea.
Claim 20 merely describes determining the reference dataset and evaluating the received subject value data, which further defines the abstract idea.
Claim 20 also includes the additional element of “an evaluation algorithm from a plurality of algorithms” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim 21 merely describes the plurality of reference datasets, the plurality of algorithms, and the algorithm selection instructions, which further defines the abstract idea.
Claim 21 also includes the additional element of “the plurality of algorithms comprises a first algorithm and a second algorithm” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim 22 merely describes the evaluation algorithm, which further defines the abstract idea.
Claim 22 also includes the additional element of “the evaluation algorithm comprises a trained gradient boosting artificial intelligence algorithm” which generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) and MPEP 2106.05(A) indicate that merely “generally linking” the abstract idea to a particular technological environment or field of use cannot provide a practical application or significantly more.
Claim 23 merely describes the value for prior history of cardiac disease, the at least one troponin value, the circumstances under which the patient is evaluated, and determining the risk of MACE, which further defines the abstract idea.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 10-12, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Body (WO 2014/199119) in view of Alaupovic et al. (U.S. 2014/0303902) and Harley et al. (U.S. 2021/0319907), referred to hereinafter as Alaupovic and Harley, respectively.
REGARDING CLAIM 1
Body teaches the claimed computer-implemented method of determining a risk of a major adverse cardiovascular event, MACE, in a patient, the method comprising: [Page 2, Line 3-4 teaches a method of determining a likelihood of a MACE of a subject.]
(a) receiving, with a computing device, subject value data for the patient, the subject value data including [Claim 17 teaches storing, with a computing device, values from the subject.]
(i) at least one troponin value, [Claim 17 teaches values indicative of quantities of troponin.]
[…]
[…]
(i) at least one troponin value, [Claim 17 teaches values indicative of quantities of troponin.]
(d) determining the risk of MACE based on the evaluation from step (c). [Col. 25, Line 2-3 teaches determining the likelihood of the subject experiencing a MACE based on differences in levels.]
Body may not explicitly teach
(ii) at least one demographic value, and
(iii) a value for prior history of cardiac disease;
(c) evaluating, with the computing device, the received subject value data of the patient based on the reference dataset;
However, Alaupovic teaches the following:
(ii) at least one demographic value, and [Para. 0075 teaches age, gender, and race.]
(iii) a value for prior history of cardiac disease; [Para. 0075 teaches previous history of disease.]
(c) evaluating, with the computing device, the received subject value data of the patient based on the reference dataset; [The level of at least one marker of the first dataset is compared with the threshold level of the at least one marker of the second dataset.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body to include demographic and disease history values in the subject data and evaluate the subject data based on reference data as taught by Alaupovic, with the motivation of improving treatment of subjects with cardiovascular disease (see Alaupovic at Para. 0008).
Body in view of Alaupovic may not explicitly teach
(b) determining a reference dataset based on the subject value data for the patient, wherein the reference dataset comprises reference subject values associated with one or more reference patients, wherein the reference subject values include, for each of the one or more reference patients:
However, Harley teaches the following:
(b) determining a reference dataset based on the subject value data for the patient, wherein the reference dataset comprises reference subject values associated with one or more reference patients, wherein the reference subject values include, for each of the one or more reference patients: [TABLE 1 teaches aligning subject data with clinical (reference) data. Para. 0114 teaches sample-to-sample comparison and sample to cohort comparison.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic to determine a reference dataset based on subject data as taught by Harley, with the motivation of providing clinical insights and actionability for patients (see Harley at Para. 0002).
REGARDING CLAIM 2
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
wherein each of the subject value data and the reference subject values further comprise
(iv) at least one of an erythrocyte mean corpuscular hemoglobin value and an electrolyte value. [Para. 0072 teaches comparing analyte values in a receipt of data to analyte levels in other subjects. Para. 0070 teaches “analyte” encompasses electrolytes.]
REGARDING CLAIM 3
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
wherein each of the subject value data and the reference subject values further comprise (v) a value for prior history of renal disease. [Para. 0075 teaches previous history of disease. Para. 0118 teaches diseases include cardiovascular diseases. Cardiovascular diseases include renal disease.]
REGARDING CLAIM 4
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
wherein the reference dataset is indicative of one or more threshold values for one or more of the reference subject values. [Claim 1 teaches a second dataset comprising data indicating a predetermined threshold level of at least one marker. The threshold level is determined from a database comprising data associated with a plurality of (reference) subjects.]
REGARDING CLAIM 10
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
wherein each of the subject value data and the reference subject values further comprise an electrolyte value; [Para. 0072 teaches comparing analyte values in a receipt of data to analyte levels in other subjects. Para. 0070 teaches “analyte” encompasses electrolytes.]
Body in view of Alaupovic and Harley may not explicitly teach
and wherein the at least one electrolyte value of the subject value data includes at least one of a magnesium value and a potassium value.
However, the limitation claims information that do not result in a manipulative difference between the information of the prior art and the functionally of the claimed method. The function taught by the prior art would be performed the same regardless of whether the information was substituted with nothing. Because Alaupovic teaches an electrolyte value, substituting the information of the claimed invention for the information of the prior art would be an obvious substitution of one known element for another, producing predictable results. Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention (time of filing) to have substituted the information applied to the electrolyte value of the prior art with any other information because the results would have been predictable. The Examiner notes that “a magnesium value and a potassium value” are not functionally utilized in the claim indicating that the information is non-functional.
REGARDING CLAIM 11
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
wherein the at least one demographic value includes at least one of a gender value, a racial value, and an age value. [Para. 0075 teaches age, gender, and race.]
REGARDING CLAIM 12
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
further comprising one or more of: determining a gender of the patient based on the demographic value; classifying the patient into an age group of a plurality of predefined age groups based on the demographic value; classifying the patient into a race group of a plurality of predefined race groups based on the demographic value; and selecting the reference dataset based on the at least one demographic value. [Para. 0088 teaches selecting the desired condition associated with a population of subjects based on age group, gender, and ethnicity. As stated above, the demographic value that is determined includes age, gender, and race (ethnicity). The Examiner notes that only one limitation is required to occur for the claim to be met.]
REGARDING CLAIM 15
Body teaches a non-transitory computer-readable medium storing instructions operable to configure a computer to perform steps of: [Claim 21 teaches a computer readable medium.]
(a) receiving subject value data for the patient, the subject value data including [Claim 17 teaches storing values from the subject.]
(i) at least one troponin value, [Claim 17 teaches values indicative of quantities of troponin.]
[…]
[…]
(i) at least one troponin value, [Claim 17 teaches values indicative of quantities of troponin.]
(d) determining the risk of MACE based on the evaluation from step (c). [Col. 25, Line 2-3 teaches determining the likelihood of the subject experiencing a MACE based on differences in levels.]
Body may not explicitly teach
(ii) at least one demographic value, and
(iii) a value for prior history of cardiac disease;
(c) evaluating the received subject value data of the patient based on the reference dataset;
However, Alaupovic teaches the following:
(ii) at least one demographic value, and [Para. 0075 teaches age, gender, and race.]
(iii) a value for prior history of cardiac disease; [Para. 0075 teaches previous history of disease.]
(c) evaluating the received subject value data of the patient based on the reference dataset; [The level of at least one marker of the first dataset is compared with the threshold level of the at least one marker of the second dataset.]
Motivation to combine the teaching of Alaupovic with the teaching of Body is the same as that used with respect to claim 1 and is therefore reiterated here.
Body in view of Alaupovic may not explicitly teach
(b) determining a reference dataset based on the subject value data for the patient, wherein the reference dataset comprises reference subject values associated with one or more reference patients, wherein the reference subject values include, for each of the one or more reference patients:
However, Harley teaches the following:
(b) determining a reference dataset based on the subject value data for the patient, wherein the reference dataset comprises reference subject values associated with one or more reference patients, wherein the reference subject values include, for each of the one or more reference patients: [TABLE 1 teaches aligning subject data with clinical (reference) data. Para. 0114 teaches sample-to-sample comparison and sample to cohort comparison.]
Motivation to combine the teaching of Harley with the teachings of Body and Alaupovic is the same as that used with respect to claim 1 and is therefore reiterated here.
REGARDING CLAIM 16
Body teaches a computing device configured to perform steps of: [Claim 17 teaches a computing device for determining a likelihood of a major adverse cardiac event.]
(a) receiving subject value data for the patient, the subject value data including [Claim 17 teaches storing values from the subject.]
(i) at least one troponin value, [Claim 17 teaches values indicative of quantities of troponin.]
[…]
[…]
(i) at least one troponin value, [Claim 17 teaches values indicative of quantities of troponin.]
(d) determining the risk of MACE based on the evaluation from step (c). [Col. 25, Line 2-3 teaches determining the likelihood of the subject experiencing a MACE based on differences in levels.]
Body may not explicitly teach
(ii) at least one demographic value, and
(iii) a value for prior history of cardiac disease;
(c) evaluating the received subject value data of the patient based on the reference dataset;
However, Alaupovic teaches the following:
(ii) at least one demographic value, and [Para. 0075 teaches age, gender, and race.]
(iii) a value for prior history of cardiac disease; [Para. 0075 teaches previous history of disease.]
(c) evaluating the received subject value data of the patient based on the reference dataset; [The level of at least one marker of the first dataset is compared with the threshold level of the at least one marker of the second dataset.]
Motivation to combine the teaching of Alaupovic with the teaching of Body is the same as that used with respect to claim 1 and is therefore reiterated here.
Body in view of Alaupovic may not explicitly teach
(b) determining a reference dataset based on the subject value data for the patient, wherein the reference dataset comprises reference subject values associated with one or more reference patients, wherein the reference subject values include, for each of the one or more reference patients:
However, Harley teaches the following:
(b) determining a reference dataset based on the subject value data for the patient, wherein the reference dataset comprises reference subject values associated with one or more reference patients, wherein the reference subject values include, for each of the one or more reference patients: [TABLE 1 teaches aligning subject data with clinical (reference) data. Para. 0114 teaches sample-to-sample comparison and sample to cohort comparison.]
Motivation to combine the teaching of Harley with the teachings of Body and Alaupovic is the same as that used with respect to claim 1 and is therefore reiterated here.
REGARDING CLAIM 17
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
wherein each of the subject value data and the reference subject values further comprises:
at least one of an erythrocyte mean corpuscular hemoglobin value and an electrolyte value; [Para. 0072 teaches comparing analyte values in a receipt of data to analyte levels in other subjects. Para. 0070 teaches “analyte” encompasses electrolytes.]
and a value for prior history of renal disease. [Para. 0075 teaches previous history of disease. Para. 0118 teaches diseases include cardiovascular diseases. Cardiovascular diseases include renal disease.]
Claims 5, 6, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Body in view of Alaupovic, Harley, and Snider et al. (U.S. 2009/0264779), referred to hereinafter as Snider.
REGARDING CLAIM 5
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Body in view of Alaupovic and Harley may not explicitly teach
wherein each of the one or more reference patients in the reference dataset has a prior history of renal disease based on determining an estimated Glomerular Filtration Rate value (eGFR) or creatinine value.
However, Snider teaches the following:
wherein each of the one or more reference patients in the reference dataset has a prior history of renal disease based on determining an estimated Glomerular Filtration Rate value (eGFR) or creatinine value. [Para. 0016 teaches determining the level of an adjunct biomarker, e.g., measures of renal function, e.g., creatinine or glomerular filtration rate, in the sample. The level of the adjunct biomarker in the sample indicates whether the subject has a disease.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic and Harley to determine a patient has renal disease as taught by Snider, with the motivation of improving patient care and reducing overall healthcare costs (see Snider at Para. 0003).
REGARDING CLAIM 6
Body in view of Alaupovic, Harley, and Snider teaches the claimed method according to claim 5.
Snider further teaches
processing historic patient data indicative of a medical disease history of the patient; [Para. 0016 teaches the level of the adjunct biomarker in the sample indicates whether the subject has a disease. The method includes determining a change in levels over time.]
and determining the patient has a prior history of renal disease based on determining an estimated Glomerular Filtration Rate value (eGFR) or creatinine value. [Para. 0016 teaches determining the level of an adjunct biomarker, e.g., measures of renal function, e.g., creatinine or glomerular filtration rate, in the sample. The level of the adjunct biomarker in the sample indicates whether the subject has a disease.]
REGARDING CLAIM 9
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Body in view of Alaupovic and Harley may not explicitly teach
processing historic patient data indicative of a medical disease history of the patient;
and determining the patient has a prior history of cardiac disease based on determining whether the patient was previously diagnosed with a cardiac disease.
However, Snider teaches the following:
processing historic patient data indicative of a medical disease history of the patient; [Para. 0016 teaches the level of the adjunct biomarker in the sample indicates whether the subject has a disease. The method includes determining a change in levels over time.]
and determining the patient has a prior history of cardiac disease based on determining whether the patient was previously diagnosed with a cardiac disease. [Para. 0062 teaches measuring biomarkers indicative of cardiac disease. Para. 0016 teaches determining the level of a biomarker in the sample. The level of the biomarker in the sample indicates whether the subject has a disease.]
Motivation to combine the teaching of Snider with the teachings of Body, Alaupovic, and Harley is the same as that used with respect to claim 5 and is therefore reiterated here.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Body in view of Alaupovic, Harley, Snider, and Ouyang et al. (U.S. 2024/0212857), referred to hereinafter as Ouyang.
REGARDING CLAIM 7
Body in view of Alaupovic, Harley, and Snider teaches the claimed method according to claim 6.
Body in view of Alaupovic, Harley, and Snider may not explicitly teach
wherein a threshold indicative of renal disease is a creatinine value above 1.3 mg/dL.
However, Ouyang teaches the following:
wherein a threshold indicative of renal disease is a creatinine value above 1.3 mg/dL. [Para. 0005 teaches calculating a cardiac risk index based on risk factors including creatinine greater than 2mg/dL (about 1.3 mg/dL).]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic, Harley, and Snider to create a creatinine value-based threshold as taught by Ouyang, with the motivation of improving the decision-making process for surgery (see Ouyang at Para. 0012).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Body in view of Alaupovic, Harley, Snider, and Datwyler et al. (U.S. 8658384), referred to hereinafter as Datwyler.
REGARDING CLAIM 8
Body in view of Alaupovic, Harley, and Snider teaches the claimed method according to claim 6.
Body in view of Alaupovic, Harley, and Snider may not explicitly teach
wherein a threshold indicative of renal disease is an eGFR value of about 60 mL/min/1.73 m2.
However, Datwyler teaches the following:
wherein a threshold indicative of renal disease is an eGFR value of about 60 mL/min/1.73 m2. [Col. 4, Line 21-23 teaches an eGFR level less than or equal to approximately 68 mL/min/1.73 m2 (about 60 mL/min/1.73 m2) indicates the patient has a moderate risk of experiencing a MACE.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic, Harley, and Snider to create an eGFR value-based threshold as taught by Datwyler, with the motivation of saving lives (see Datwyler at Col. 3, Line 24).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Body in view of Alaupovic, Harley, and Lewis (U.S. 2018/0166174).
REGARDING CLAIM 13
Body in view of Alaupovic and Harley teaches the claimed method according to claim 1.
Alaupovic further teaches
…evaluating the further subject value data based on one or more further reference subject values indicated by the reference dataset… [Claim 1 teaches a second dataset comprising data indicating a predetermined threshold level of at least one marker. The threshold level is determined from a database comprising data associated with a plurality of (reference) subjects. The level of at least one marker of the first dataset is compared with the threshold level of the at least one marker of the second dataset.]
Body in view of Alaupovic and Harley may not explicitly teach
receiving further subject value data for the patient, the further subject value data including one or more of a ratio of oxyhemoglobin to hemoglobin, a ratio of neutrophils per leukocytes, a ratio of nucleated erythrocytes to leukocyte, and a ratio of eosinophils to leukocytes;
and […] the one or more reference subject values being indicative of one or more of a ratio of oxyhemoglobin to hemoglobin, a ratio of neutrophils per leukocytes, a ratio of nucleated erythrocytes to leukocyte, and a ratio of eosinophils to leukocytes.
However, Lewis teaches the following:
receiving further subject value data for the patient, the further subject value data including one or more of a ratio of oxyhemoglobin to hemoglobin, a ratio of neutrophils per leukocytes, a ratio of nucleated erythrocytes to leukocyte, and a ratio of eosinophils to leukocytes; [Para. 0143 teaches receiving subject biomarker data. Para. 0144 teaches biomarkers include a neutrophil-to-leukocyte ratio.]
and […] the one or more reference subject values being indicative of one or more of a ratio of oxyhemoglobin to hemoglobin, a ratio of neutrophils per leukocytes, a ratio of nucleated erythrocytes to leukocyte, and a ratio of eosinophils to leukocytes. [Para. 0143 teaches receiving subject biomarker data. Para. 0144 teaches biomarkers include a neutrophil-to-leukocyte ratio.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic and Harley to receive a neutrophil-to-leukocyte ratio as taught by Lewis, with the motivation of improving outcomes (see Lewis at Para. 0115).
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Body in view of Alaupovic, Harley, and Lipscher et al. (U.S. 2013/0066648), referred to hereinafter as Lipscher.
REGARDING CLAIM 20
Body in view of Alaupovic and Harley teaches the method of claim 1.
Harley further teaches
determining the reference dataset based on the subject value data for the patient comprises selecting the reference dataset from a plurality of reference datasets; and [TABLE 1 teaches aligning subject data with clinical (reference) data. Para. 0114 teaches sample-to-sample comparison and sample to cohort comparison.]
Harley may not explicitly teach
(b) evaluating the received subject value data based on the reference dataset comprises executing algorithm selection instructions, wherein the algorithm selection instructions comprise instructions operable to selectively invoke an evaluation algorithm from a plurality of algorithms based on the subject value data when executed.
However, Lipscher teaches the following:
(b) evaluating the received subject value data based on the reference dataset comprises executing algorithm selection instructions, wherein the algorithm selection instructions comprise instructions operable to selectively invoke an evaluation algorithm from a plurality of algorithms based on the subject value data when executed. [Para. 0079 teaches selecting an algorithm by matching algorithm conditions against findings about the patient.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic and Harley to use algorithm selection to evaluate received data as taught by Lipscher, with the motivation of improving quality of care (see Lipscher at Para. 0138).
REGARDING CLAIM 21
Body in view of Alaupovic, Harley, and Lipscher teaches the method of claim 20.
Alaupovic further teaches
the plurality of reference datasets comprises a first reference dataset and a second reference dataset; [Para. 0009 teaches comparing the first sample dataset to a second (reference) dataset. Para. 0034 teaches comparing the first sample dataset to a third (reference) dataset.]
Lipscher further teaches
(b) the plurality of algorithms comprises a first algorithm and a second algorithm, wherein the first algorithm includes the first reference dataset and the second algorithm includes the second reference dataset; and (c) the algorithm selection instructions comprise instructions to: [Para. 0079 teaches selecting an algorithm by matching algorithm conditions against findings about the patient.]
Alaupovic further teaches
(i) when the patient has a prior history of cardiac disease, invoke the first algorithm; and [Para. 0118 teaches cardiac disease.]
(ii) when the patient has a prior history of renal disease, invoke the second algorithm. [Para. 0118 teaches renal disease.]
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Body in view of Alaupovic, Harley, Lipscher and Ouyang.
REGARDING CLAIM 22
Body in view of Alaupovic, Harley, and Lipscher teaches the method of claim 20.
Body further teaches
at least one troponin value, [Claim 17 teaches values indicative of quantities of troponin.]
Alaupovic further teaches
at least one demographic value, and [Para. 0075 teaches age, gender, and race.]
a value for prior history of cardiac disease. [Para. 0118 teaches cardiac disease.]
Body in view of Alaupovic, Harley, and Lipscher may not explicitly teach
wherein the evaluation algorithm comprises a trained gradient boosting artificial intelligence algorithm includes a plurality of parameters of the reference dataset with values trained based on a raw reference dataset of reference patients filtered based on
However, Ouyang teaches the following:
wherein the evaluation algorithm comprises a trained gradient boosting artificial intelligence algorithm includes a plurality of parameters of the reference dataset with values trained based on a raw reference dataset of reference patients filtered based on [Para. 0142 teaches a gradient boost.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic, Harley, and Lipscher to use a gradient boost algorithm as taught by Ouyang, with the motivation of improving the decision-making process for surgery (see Ouyang at Para. 0012).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Body in view of Alaupovic, Harley, and Snider et al. (U.S. 2013/0244236), referred to hereinafter as Snider ‘236.
REGARDING CLAIM 23
Body in view of Alaupovic and Harley teaches the method of claim 1.
Alaupovic further teaches
the value for prior history of cardiac disease in the subject value data for the patient indicates a prior history of cardiac disease; [Para. 0118 teaches cardiac disease.]
Body further teaches
(b) the at least one troponin value in the subject value data for the patient falls into an indeterminate range of troponin values; [Claim 17 teaches values indicative of quantities of troponin.]
Body in view of Alaupovic and Harley may not explicitly teach
(c) the patient is evaluated at an emergency department with suspicion of a cardiac event; and
(d) determining the risk of MACE comprises predicting a risk of another cardiac event within thirty days.
However, Snider ‘263 teaches the following:
(c) the patient is evaluated at an emergency department with suspicion of a cardiac event; and [Para. 0076 teaches an emergency department (ED).]
(d) determining the risk of MACE comprises predicting a risk of another cardiac event within thirty days. [Para. 0004 teaches predicting the likelihood of MACE within a specific time period, e.g., 30 days.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the computer-implemented method of Body in view of Alaupovic, and Harley to determine the risk of MACE within thirty days as taught by Snider ‘263, with the motivation of improving patient care (see Snider ‘263 at Para. 0003).
Response to Arguments
Claim Objections
Regarding the objection(s) to Claims 6, 7, and 9, the Applicant has amended the claims to overcome the basis/bases of objection.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-13, 15-17, and 20-23, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
…an improvement to clinical decision support systems is provided… claim 1 provides an improvement to clinical decision support technology.
Regarding (a), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) states “the word ‘improvements’ in the context of this consideration is limited to improvements to the functioning of a computer or any other technology/technical field, whether in Step 2A Prong Two or in Step 2B.” Here, there is no improvement to the computer nor is there an improvement to another technology. Because neither type of improvement is present in the claims, an improvement to technology is not present and there is no practical application.
Applicant’s argument that the field of clinical decision support is a technology and the claimed invention improves this field is not reflected in the claimed invention. The claims are confined to a general-purpose computer and do not claim clinical decision support. Moreover, the entire field of clinical decision support is not reasonably understood to be a problem arising in technology, as it is instead a problem arising in healthcare. The claimed invention is using a computer as a tool and any improvement present is an improvement to the abstract idea of, to paraphrase, assessing for risk of a major adverse cardiac event. Finally, if Applicant’s line of reasoning were correct, the invention in Alice Corp. would have been subject matter eligible because it was an improvement to the technology of settlement risk mitigation.
…a claim which recites specific implementation features which improve an abstract idea can amount to an improvement in computers and therefore be sufficient to establish eligibility. This can be seen from the case of Finjan, Inc. v. Blue Coat Systems, Inc… Similarly… claim 1 does more than simply reciting a result. Instead, it recites specific steps… that accomplish the result.
Regarding (b), the Examiner respectfully disagrees. As per Finjan, the claims in that case employ a new kind of file that enables a computer security system to do things it could not do before. The security profile approach allows access to be tailored for different users and ensures that threats are identified before a file reaches a user’s computer. The fact that the security profile “identifies suspicious code” allows the system to accumulate and utilize newly available, behavior-based information about potential threats. The asserted claims are therefore directed to a non-abstract improvement in computer functionality, rather than the abstract idea of computer security writ large. As shown in the analysis in the above rejection, the present claims are directed toward an abstract idea and do not address a technological problem similar to the argued case.
Rejection under 35 U.S.C. § 112
Regarding the indefiniteness rejection of Claims 15 and 16, the Applicant has amended the claims to overcome the basis/bases of rejection.
Rejection under 35 U.S.C. § 102/103
Regarding the rejection of Claims 1-13, 15-17, and 20-23, the Examiner has considered the Applicant’s arguments; however, these arguments are moot given the new grounds of rejection as necessitated by amendment.
Conclusion
Prior art made of record though not relied upon in the present basis of rejection are noted in the attached PTO 892 and include:
Klein et al. (U.S. 2022/0031218) which discloses using machine-learning algorithms to assess cardiac function.
Sullivan et al. (U.S. 2016/0135706) which discloses a system and method for premonitory event estimation.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683