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 .
Drawings
The drawings filed on 09/29/2023 are accepted.
Specification
The specification filed on 09/29/2023 is accepted.
Information Disclosure Statement
The examiner has considered the information disclosure statements (IDS) submitted on 04/05/2024 and 03/21/2025.
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 4-6, 8 and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 recites the limitation “the extraction filter” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 4 recites the limitation “the first set of characteristics” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claims 5-6 and 8 are rejected for being dependent on a rejected base claim, namely claim 4.
Claim 26 recites the limitation “the applying” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-6, 8, 11-13, 15-16, 20, 22-24, 26, 31, 37-39 and 42-43 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.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “generating a plurality of labeling functions for the medical condition, wherein each respective labeling function in the plurality of labeling functions comprises a corresponding set of one or more criterion that, when satisfied, indicate a presence of the medical condition”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “generating” in the context of this claim encompasses the user/expert generates a set of medical rules to determine a medical condition of a patient, a rule can be if a patient has a symptom A then the patient is diagnosed with a disease B.
The limitation of “assigning, to each respective subject in a first plurality of subjects, a corresponding label indicating a status of the medical condition by evaluating first information from a corresponding medical record for the respective subject using an ensemble model”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. That is, other than reciting “an ensemble model” nothing in the claim element precludes the step from practically being performed in the mind. For example, “assigning” in the context of this claim encompasses the user/expert determines that the patient is diagnosed with a certain disease based on the lab results or symptoms of the patient.
If a claim, under the broadest reasonable interpretation covers concepts that can be performed in the human mind, or by a human using a pen and paper, including observation, evaluation, judgment, or opinion, it will be considered as falling within the "mental process” grouping of abstract ideas.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. In particular, the claim recites the additional elements of “a computer system”, “one or more processors” and “memory”. The additional elements are recited at a high-level of generality (i.e., as a generic device performing the generic computer functions) such that they amount no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim recites the additional element of “evaluating first information … using an ensemble model comprising the plurality of labeling functions to obtain as output from the ensemble model a prediction for the status of the medical condition”. This limitation is recited at a high-level of generality (i.e., as a generic device performing the generic computer functions) such that it amounts to no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The additional element of “wherein the evaluating comprises natural language processing of at least a portion of the respective medical record” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 elements of “a computer system”, “one or more processors” and “memory” to perform the generic computer functions amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The additional element of “evaluating first information … using an ensemble model comprising the plurality of labeling functions to obtain as output from the ensemble model a prediction for the status of the medical condition” amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The additional element of “wherein the evaluating comprises natural language processing of at least a portion of the respective medical record” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 2 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “filtering a second plurality of subjects in accordance with a first set of characteristics for the medical condition”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “filtering” in the context of this claim encompasses the user/expert determines a group of patients who are diagnosed with a same disease.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the filtering comprises applying an extraction filter to medical records corresponding to the second plurality of subjects, to obtain the first plurality of subjects, wherein the first plurality of subjects is a subset of the second plurality of subjects” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the filtering comprises applying an extraction filter to medical records corresponding to the second plurality of subjects, to obtain the first plurality of subjects, wherein the first plurality of subjects is a subset of the second plurality of subjects” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The claim recites the additional element of “training a classification model for phenotyping subjects with respect to the medical condition using, for each respective subject in the first plurality of subjects, (i) the corresponding label as a dependent variable and (ii) second information from the corresponding medical record as independent variables”. This limitation is recited at a high-level of generality (i.e., as a generic device performing the generic computer functions) such that it amounts to no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claim does 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 “training a classification model for phenotyping subjects with respect to the medical condition using, for each respective subject in the first plurality of subjects, (i) the corresponding label as a dependent variable and (ii) second information from the corresponding medical record as independent variables” amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 4 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional elements of “the extraction filter comprises a plurality of criteria related to the first set of characteristics for the medical condition” and “applying the extraction filter to the plurality of medical records comprises, for each respective medical record in a second plurality of medical records, evaluating the respective medical record for respective criterion in the plurality of criteria, wherein satisfaction of a single respective criterion is sufficient for inclusion or exclusion of the respective medical record in a first plurality of medical records” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 elements of “the extraction filter comprises a plurality of criteria related to the first set of characteristics for the medical condition” and “applying the extraction filter to the plurality of medical records comprises, for each respective medical record in a second plurality of medical records, evaluating the respective medical record for respective criterion in the plurality of criteria, wherein satisfaction of a single respective criterion is sufficient for inclusion or exclusion of the respective medical record in a first plurality of medical records” amount to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 5 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “evaluating, for one or more respective subjects in the second plurality of subjects excluded from the first plurality of subjects, whether the corresponding medical record indicates the presence of the medical condition independent of the evaluation of the respective medical record during application of the extraction filter”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “evaluating” in the context of this claim encompasses the user/expert determines a group of patients who are diagnosed with a disease.
The limitation of “upon a determination that the respective medical record indicates the presence of the medical condition, revising the plurality of criteria related to the first set of characteristics to be more inclusive when applying the extraction filter”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “revising” in the context of this claim encompasses the user/expert updates the generated medical rules to include a newly pair of symptom-disease, or to link some medical results/measurements to a disease.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Indeed, the claim does not recite any additional element beside the limitation that can be performed in a human mind. The claim is not patent eligible.
Step 2B:
The claim does 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 claim does not recite any additional element beside the limitation that can be performed in a human mind. The claim is not patent eligible.
Claim 6 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitations of “evaluating a first data type … and evaluating a second data type”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “evaluating” in the context of this claim encompasses the user/expert monitors the sugar level and blood pressure of the patient from the lab results.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein applying the extraction filter comprises, for each respective subject in the second plurality of subjects, evaluating …” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein applying the extraction filter comprises, for each respective subject in the second plurality of subjects, evaluating …” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 8 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein applying the extraction filter comprises evaluating at least three data types selected from: structured electronic health record (EHR) data; unstructured EHR data; laboratory results; prescribed medications; and performed medical procedures” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein applying the extraction filter comprises evaluating at least three data types selected from: structured electronic health record (EHR) data; unstructured EHR data; laboratory results; prescribed medications; and performed medical procedures” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the plurality of labeling functions comprises a respective labeling function for each respective subgroup in a plurality subgroups of subjects with the medical condition” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the plurality of labeling functions comprises a respective labeling function for each respective subgroup in a plurality subgroups of subjects with the medical condition” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the plurality of labeling functions comprises a first respective labeling function comprising a corresponding set of one or more criterion that, when satisfied, indicate a presence of the medical condition” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the plurality of labeling functions comprises a first respective labeling function comprising a corresponding set of one or more criterion that, when satisfied, indicate a presence of the medical condition” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 13 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites a method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitation of “defining a first set of one or more criterion that, when satisfied, indicate the presence of the medical condition”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “defining” in the context of this claim encompasses the user/expert determines a set of rules such as if a patient has high blood sugar level then the patient is diagnosed with diabetes.
The limitation of “determining, for each respective subject in a first subset of the first plurality of subjects, whether the corresponding medical record for the respective subject satisfies the first set of one or more criterion”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “determining” in the context of this claim encompasses the user/expert determines if the blood sugar level of the patient is high.
The limitation of “evaluating, for a respective subject in the first subset of the first plurality of subjects determined to satisfy the first set of one or more criteria whether the corresponding medical record indicates the absence of the medical condition, independent of the determination of whether the corresponding medical record satisfies the first set of one or more criterion”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “evaluating” in the context of this claim encompasses the user/expert views lab results or health data record that do not contain data relating to diabetes.
The limitation of “upon a determination that the corresponding medical record indicates the absence of the medical condition, revising the first set of one or more criteria to be less inclusive”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “revising” in the context of this claim encompasses the user/expert changing the rules to not include those data/symptoms when determining if the patient is diagnosed with diabetes.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Indeed, the claim does not recite any additional element beside the limitation that can be performed in a human mind. The claim is not patent eligible.
Step 2B:
The claim does 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 claim does not recite any additional element beside the limitation that can be performed in a human mind. The claim is not patent eligible.
Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the plurality of labeling functions comprises a second respective labeling function comprising a corresponding set of one or more criterion that, when satisfied, indicate an absence of the medical condition” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the plurality of labeling functions comprises a second respective labeling function comprising a corresponding set of one or more criterion that, when satisfied, indicate an absence of the medical condition” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 16 is rejected by the same reason as of claim 13, since these claims recite the similar limitations.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the ensemble model comprises an aggregate voting model based on the evaluation of each respective labeling function” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the ensemble model comprises an aggregate voting model based on the evaluation of each respective labeling function” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 22 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the ensemble model comprises a probabilistic graphical model” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the ensemble model comprises a probabilistic graphical model” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 1):
The limitations of “evaluating a first data type … and evaluating a second data type”, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. For example, “evaluating” in the context of this claim encompasses the user/expert monitors the sugar level and blood pressure of the patient from the lab results.
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein, for each respective subject in the first plurality of subjects, evaluating the ensemble model comprising the plurality of labeling functions comprises evaluating …” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein, for each respective subject in the first plurality of subjects, evaluating the ensemble model comprising the plurality of labeling functions comprises evaluating …” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 24 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the first data type is structured data in an electronic health record (EHR) and the second type of data is unstructured data in the EHR” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the first data type is structured data in an electronic health record (EHR) and the second type of data is unstructured data in the EHR” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 26 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein, for a respective subject in the plurality of subjects, the applying comprises natural language processing of unstructured clinical notes from the EHR” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein, for a respective subject in the plurality of subjects, the applying comprises natural language processing of unstructured clinical notes from the EHR” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 31 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the second information comprises at least two data types” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the second information comprises at least two data types” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 37 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the medical condition is pulmonary hypertension” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the medical condition is pulmonary hypertension” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 38 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The additional element of “wherein the medical condition is pulmonary hypertension and the second information comprises electrocardiogram results” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not integrate into a practical application (see MPEP 2106.05(h)).
Step 2B:
The claim does 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 “wherein the medical condition is pulmonary hypertension and the second information comprises electrocardiogram results” amounts to no more than generally linking the use of a judicial exception to a particular technological environment or field of use. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible "simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use." Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitation that amounts to merely indicating a field of use or technological environment in which to apply a judicial exception does not amount to significantly more than the judicial exception (see MPEP 2106.05(h)).
Claim 39 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
The claim recites the method which falls within at least one of the four statutory categories of patent eligible subject matter.
Step 2:
Step 2A (prong 2):
This judicial exception is not integrated into a practical application. The claim recites the additional element of “identifying, from a plurality of previously undiagnosed subjects, one or more respective subjects having the medical condition by inputting, for each respective subject in the plurality of subjects, corresponding second information for the respective subject into the classification model to receive as output a corresponding indication of whether the respective subject has the medical condition”. This limitation is recited at a high-level of generality (i.e., as a generic device performing the generic computer functions) such that it amounts to no more than mere instructions to apply the exception using the generic computer components (MPEP 2106.05(f)). Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
Step 2B:
The claim does 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 “identifying, from a plurality of previously undiagnosed subjects, one or more respective subjects having the medical condition by inputting, for each respective subject in the plurality of subjects, corresponding second information for the respective subject into the classification model to receive as output a corresponding indication of whether the respective subject has the medical condition” amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
Claim 42 is rejected by the same reason as of claim 1, since these claims recite the similar limitations.
Claim 43 is rejected by the same reason as of claim 1, since these claims recite the similar limitations.
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 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 1-6, 8, 11-13, 15-16, 20, 22-24, 26, 31, 39 and 42-43 are rejected under 35 U.S.C. 103 as being unpatentable over Shankar et al. (US Pub. 2017/0277841) in view of Sanae et al. (US Pub. 2023/0110360).
As per claim 1, Shankar teaches a method for training a model for phenotyping subjects with respect to a medical condition [paragraph 0007, “A computer-implemented method for medical analysis”], comprising:
at a computer system that includes one or more processors and memory [paragraph 0007, “computer system for medical analysis comprising: a memory which stores instructions; one or more processors attached to the memory”]:
generating a plurality of labeling functions for the medical condition [paragraph 0048, “The rules engine 310 takes a structured and consistent knowledge representation 314 of all available medical knowledge information and best practices. Natural language processing 312 can be used to process the knowledge representation 314 into medical rules through the rule engine 310. The rules from rules engine 310 are ordered into nodes and edges using one or more graph algorithms 320. The resulting graph is a medical probabilistic rule graph … The graph algorithms can order the medical knowledge data rules into a directed acyclic graph (DAG) … The customized graph enables providing clinical delivery 334 of diagnoses and/or treatments”; Fig. 5, paragraph 0059 discloses a medical probabilistic rule graph comprises a plurality of nodes, medical knowledge information and a set of medical rules (not shown), wherein, “Node 1, for example, could indicate a symptom of fainting … Node 3, for example, could be the metric of high blood pressure, and Node 4, for example, could be the metric of low blood pressure … Node 5, for example, could be the diagnosis of the heart disease”; Fig. 5 shows the connections in order between nodes 1, 3, 4 and 5; Examiner interprets the medical rules comprising nodes and edges as labeling functions for the medical condition. Based on the reciting above, it can be seen that one of the medical rules including in the rule graph can be if a patient has a symptom of fainting (node 1), high blood pressure (node 3), or low blood pressure (node 4) then the patient is diagnosed with heart disease (node 5)], wherein each respective labeling function in the plurality of labeling functions comprises a corresponding set of one or more criterion [paragraph 0082, “FIG. 17 illustrates natural language processing for application of criteria to patient data … The NL statement can be received where the NL statement can be related to a variety of medical conditions, diagnoses, treatments etc. Various criteria can be applied 1720 to the biological information from the individual in order to diagnose an ailment, to recommend a treatment, etc.,” Fig. 17 shows an example of a criterion “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”]; and
assigning, to each respective subject in a first plurality of subjects, a corresponding label indicating a status of the medical condition by evaluating first information from a corresponding medical record for the respective subject using an ensemble model comprising the plurality of labeling functions to obtain as output from the ensemble model a prediction for the status of the medical condition [abstract, “Biological information and medical knowledge information are used for self-learning clinical intelligence. Medical knowledge information is assembled. Medical rules are generated based on the medical knowledge. The medical rules can be generated probabilistically. A plurality of risk models can be learned. The plurality of risk models are associated with a given disease based on patient attributes. A medical probabilistic rule graph is built based on the medical rules and the plurality of risk models. The building of the medical probabilistic rule graph is based on ordering the medical rules”; Fig. 5 shows a process of evaluating the medical knowledge information 510 (for example node 1, symptom of fainting) and medical metrics 520 of the patients (for example node 3, high blood pressure), and certain diseases (nodes 5, 6, ... 1011, 1012, heart disease (node 5)) are assigned/labeled based on the evaluating; paragraph 0062, “The self-learning clinical intelligence system can be based on biological information and medical knowledge information. The self-learning clinical intelligence system can include obtaining medical metrics, receiving biological information and other information from an individual, and applying the medical metrics to the biological information from the individual. The medical metrics can be applied to the biological information from the individual to diagnose an ailment, recommend a treatment, and so on. The medical data analysis sources can include electronic medical records (EMR), clinical records, and so on”; examiner interprets the medical probabilistic rule graph which is built based on the medical rules and the plurality of risk models as the ensemble model comprising the plurality of labeling functions], wherein the evaluating comprises natural language processing of at least a portion of the respective medical record [paragraph 0065, “FIG. 7 illustrates natural language processing of patient data. Natural language processing of patient data 700 can be performed as part of a self-learning clinical intelligence system. The self-learning clinical intelligence system can be based on biological information and medical knowledge information … The medical metrics can be applied to the biological information from the individual to diagnose an ailment, recommend a treatment, and so on. Natural language (NL) text 710 can be obtained from a file, from digital medical records”].
Shankar does not explicitly teach
one or more criterion that, when satisfied, indicate a presence of the medical condition;
Sanae teaches
one or more criterion that, when satisfied, indicate a presence of the medical condition [abstract, “A computer-implemented method for cloud-based genomic, phenotype, or diagnostic data access among a plurality of digital computers”; paragraph 0006, “the method further comprises administering a diagnostic test to said subject based at least in part on said genomic, phenotype, or diagnostic data, to detect a presence or absence of a disease or disorder in said subject”; Since Sanae teaches a diagnostic test is applied to the medical data of a patient to detect a presence or absence of a disease in the patient, while Shankar in Fig. 5 teaches if a patient has a symptom of fainting, and the blood pressure is high (criterion is satisfied), then the patient is diagnosed with a heart disease, and in Fig. 17, Shankar shows an example of a criterion “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia, therefore, the combination of Shankar and Sanae teaches the above claim limitation];
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include one or more criterion that, when satisfied, indicate a presence of the medical condition of Sanae. Doing so would help generating a treatment for the patient (Shankar, abstract).
As per claim 2, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
prior to generating the plurality of labeling functions:
filtering a second plurality of subjects in accordance with a first set of characteristics for the medical condition, wherein the filtering comprises applying an extraction filter to medical records corresponding to the second plurality of subjects, to obtain the first plurality of subjects, wherein the first plurality of subjects is a subset of the second plurality of subjects [abstract, “Medical rules are generated based on the medical knowledge”; Fig. 17 shows patients/individuals are grouped based on the medical knowledge information such as group of patients with LDL-C >= 190 mg/dL, group of patients with triglycerides >=500mg/dL, each group includes the first plurality of patients which is a subset of all patients (second plurality of subjects), and the medical rule is generated after the grouping “Individuals with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”; Since the claim does not define an extraction filter, and how the extraction filter is operated to filter the second plurality of subjects, the examiner interprets an extraction filter as a module that groups the patients based on their medical information/records].
As per claim 3, Shankar and Sanae teach the method of claim 1.
Sanae further teaches
training a classification model for phenotyping subjects with respect to the medical condition using, for each respective subject in the first plurality of subjects, (i) the corresponding label as a dependent variable and (ii) second information from the corresponding medical record as independent variables [paragraph 0006, “the method further comprises computer processing said at least said subset of said set of genomic, phenotype, or diagnostic data to detect a disease of said subject”; paragraphs 0188 and 0192, “data analytics platform may comprise one or more analytic dashboards. Different dashboards may be provided as described below, each analyzing different types of user data … advanced dashboard analyzes, predicts, and visualizes data by applying various algorithms (e.g., classification algorithms, machine learning, and pattern recognition) to a user's data. The advanced dashboard uses phenotype and genotype data to create models and predict specific features or a probability of a result, based on training data … The advanced dashboard may include one or more of … classification models as desired based on a user's data … the phenotype data comprises Electronic Health Record (EHR) data of one or more subjects (e.g., patients)”; It can be seen that the system of Sanae comprises a classification model which uses medical data (phenotype and genotype data as input (independent variables)) to predict a probability of an output (dependent variable), resulting in detecting a disease in the patient”; paragraph 0035, “An output from applying the attributes to the medical probabilistic rule graph can be accomplished using a probabilistic graph inference”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include training a classification model for phenotyping subjects with respect to the medical condition using, for each respective subject in the first plurality of subjects, (i) the corresponding label as a dependent variable and (ii) second information from the corresponding medical record as independent variables of Sanae. Doing so would help detecting a presence or absence of a disease in the patient and recommending a treatment for the patient (Sanae, 0006).
As per claim 4, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
the extraction filter comprises a plurality of criteria related to the first set of characteristics for the medical condition [Fig. 5 shows a medical probabilistic rule graph comprises nodes representing medical condition, the connecting between different nodes resulting in a certain disease. For example, one of the criteria is a patient has a symptom of fainting (node 1), high blood pressure (node 3) then the patient is diagnosed with heart disease (node 5), wherein, node 6 … 1011 and 1012 indicating different diseases]; and
applying the extraction filter to the plurality of medical records comprises, for each respective medical record in a second plurality of medical records, evaluating the respective medical record for respective criterion in the plurality of criteria, wherein satisfaction of a single respective criterion is sufficient for inclusion or exclusion of the respective medical record in a first plurality of medical records [Fig. 5, paragraphs 0059-0061 discloses a medical probabilistic rule graph has a plurality of nodes comprising medical knowledge information, medical metrics, diseases, etc., wherein, the connecting between different nodes resulting in a certain disease (one of the criteria). For example, a patient has a symptom of fainting (node 1), high blood pressure (node 3) then the patient is diagnosed with heart disease (node 5), or a patient has a symptom of fainting (node 1), low blood pressure (node 4) then the patient is diagnosed with heart disease (node 5); It can be seen that both of the examples above satisfy a single criterion, thus is sufficient for inclusion of the respective medical record in a first plurality of medical records (heart disease, for example); Fig. 17, paragraph 0082, “FIG. 17 illustrates natural language processing for application of criteria to patient data … The NL statement can be received where the NL statement can be related to a variety of medical conditions, diagnoses, treatments etc. Various criteria can be applied 1720 to the biological information from the individual in order to diagnose an ailment, to recommend a treatment, etc.,” Fig. 17 shows an example of a criterion “Individuals with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”; It can be seen that a medical record of a patient that either has LDL-C >= 190mg/dL or triglycerides >= 500mg/dL is included in a first plurality of medical records which the patient with that medical record should be evaluated for secondary causes of hyperlipidemia].
As per claim 5, Shankar and Sanae teach the method of claim 4.
Shankar further teaches
evaluating, for one or more respective subjects in the second plurality of subjects excluded from the first plurality of subjects, whether the corresponding medical record indicates the presence of the medical condition independent of the evaluation of the respective medical record during application of the extraction filter [Fig. 5, paragraphs 0059-0061 discloses a medical probabilistic rule graph has a plurality of nodes comprising medical knowledge information, medical metrics, diseases, etc., wherein, the connecting between different nodes resulting in a certain disease (one of the criteria). For example, if a patient that has medical knowledge information associated with node 1008, medical metrics associated with node 1010, then that patient is diagnosed with a disease associated with node 1012]; and
upon a determination that the respective medical record indicates the presence of the medical condition [Fig. 17 discloses patient_data.labs = {'LDL-C: (300, 'mg/dl'), and 'triglycerides': (500, 'mg/dl'), wherein, the patient with either one of the measurements should be evaluated for secondary causes of hyperlipidemia], revising the plurality of criteria related to the first set of characteristics to be more inclusive when applying the extraction filter [Fig. 17 shows an example of a criterion that including both measurements above “Individuals with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”].
As per claim 6, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
applying the extraction filter comprises, for each respective subject in the second plurality of subjects, evaluating a first data type for a first respective criterion in the plurality of criteria and evaluating a second data type for a second respective criterion in the plurality of criteria [paragraph 0062, “The self-learning clinical intelligence system can be based on biological information and medical knowledge information. The self-learning clinical intelligence system can include obtaining medical metrics, receiving biological information and other information from an individual, and applying the medical metrics to the biological information from the individual. The medical metrics can be applied to the biological information from the individual to diagnose an ailment, recommend a treatment”; paragraph 0041, “collecting biological information 142 from an individual. The individual can be a patient, and the biological information can include current biological information such as vital signs, notes from a previous visit to a medical practitioner, and other data. The biological information can include electronic medical records; paragraph 0059, “The medical knowledge information is structured and made consistent in a set of medical rules”; According to paragraph 0119 in the specification of the current Application that recite “the first data type is structured data (e.g., structured clinical data 42) in an electronic health record (EHR) and the second type of data is unstructured data in the HER … unstructured data is a clinical note in the EHR.”, examiner interprets the first data type as the structure data and the second data type as the unstructured data such as notes from a previous visit to a medical practitioner].
As per claim 8, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
applying the extraction filter comprises evaluating at least three data types selected from:
structured electronic health record (EHR) data;
unstructured EHR data;
laboratory results;
prescribed medications; and
performed medical procedures.
[paragraph 0062, “The self-learning clinical intelligence system can be based on biological information and medical knowledge information. The self-learning clinical intelligence system can include obtaining medical metrics, receiving biological information and other information from an individual, and applying the medical metrics to the biological information from the individual. The medical metrics can be applied to the biological information from the individual to diagnose an ailment, recommend a treatment”; paragraph 0041, “collecting biological information 142 from an individual. The individual can be a patient, and the biological information can include current biological information such as vital signs, notes from a previous visit to a medical practitioner, and other data. The biological information can include electronic medical records; paragraph 0059, “The medical knowledge information is structured and made consistent in a set of medical rules”; According to paragraph 0119 in the specification of the current Application that recite “the first data type is structured data (e.g., structured clinical data 42) in an electronic health record (EHR) and the second type of data is unstructured data in the HER … unstructured data is a clinical note in the EHR.”, examiner interprets the first data type as the structure data and the second data type as the unstructured data such as notes from a previous visit to a medical practitioner; Also, Fig. 17 shows an example of a lab result is evaluated “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”].
As per claim 11, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
the plurality of labeling functions comprises a respective labeling function for each respective subgroup in a plurality subgroups of subjects with the medical condition [Fig. 17 shows one of the medical rules for a certain group of patients “Individuals (subgroup in a plurality subgroups of subjects) with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”].
As per claim 12, Shankar and Sanae teach the method of claim 1.
Sanae further teaches
a first respective labeling function comprising a corresponding set of one or more criterion that, when satisfied, indicate a presence of the medical condition [abstract, “A computer-implemented method for cloud-based genomic, phenotype, or diagnostic data access among a plurality of digital computers”; paragraph 0006, “the method further comprises administering a diagnostic test to said subject based at least in part on said genomic, phenotype, or diagnostic data, to detect a presence or absence of a disease or disorder in said subject”; Since Sanae teaches a diagnostic test is applied to the medical data of a patient to detect a presence or absence of a disease in the patient, while Shankar in Fig. 5 teaches if a patient has a symptom of fainting, and the blood pressure is high (criterion is satisfied), then the patient is diagnosed with a heart disease, and in Fig. 17, Shankar shows an example of a criterion “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia, therefore, the combination of Shankar and Sanae teaches the above claim limitation];
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include a first respective labeling function comprising a corresponding set of one or more criterion that, when satisfied, indicate a presence of the medical condition of Sanae. Doing so would help generating a treatment for the patient (Shankar, abstract).
As per claim 13, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
the generating the plurality of labeling functions comprises, for the first respective labeling function:
i) defining a first set of one or more criterion that, when satisfied, indicate the presence of the medical condition [Fig. 5, paragraph 0059 discloses a medical probabilistic rule graph comprises a plurality of nodes, medical knowledge information and a set of medical rules (not shown), wherein, “Node 1, for example, could indicate a symptom of fainting … Node 3, for example, could be the metric of high blood pressure, and Node 4, for example, could be the metric of low blood pressure … Node 5, for example, could be the diagnosis of the heart disease”; Fig. 5 shows the connections in order between nodes 1, 3, 4 and 5; Examiner interprets the medical rules comprising nodes and edges as first set of one or more criterion. Based on the reciting above, it can be seen that one of the medical rules including in the rule graph can be if a patient has a symptom of fainting (node 1), high blood pressure (node 3), or low blood pressure (node 4) then the patient is diagnosed with heart disease (node 5); Fig. 17 shows an example of a criterion “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia],
ii) determining, for each respective subject in a first subset of the first plurality of subjects, whether the corresponding medical record for the respective subject satisfies the first set of one or more criterion [Fig. 5, paragraphs 0059-0061, discloses a medical probabilistic rule graph has a plurality of nodes comprising medical knowledge information, medical metrics, diseases, etc., wherein, the connecting between different nodes resulting in a certain disease (one of the criteria). For example, if a patient that has medical knowledge information associated with node 1008, medical metrics associated with node 1010, then that patient is diagnosed with a disease associated with node 1012],
iii) evaluating, for a respective subject in the first subset of the first plurality of subjects determined to satisfy the first set of one or more criteria whether the corresponding medical record indicates the absence of the medical condition, independent of the determination of whether the corresponding medical record satisfies the first set of one or more criterion [Figs. 5 and 17 shows patients/individuals are evaluated based on the medical knowledge information to determine, for example if the patient or group of patients with LDL-C >= 190 mg/dL, or with triglycerides >=500mg/dL, Fig. 17 also shows data of one patient as
PNG
media_image1.png
24
776
media_image1.png
Greyscale
, which indicating an absence of hyperlipidemia], and
iv) upon a determination that the corresponding medical record indicates the absence of the medical condition, revising the first set of one or more criteria to be less inclusive [Fig. 17 shows an example of a criterion “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”; It can be seen that patients with LDL-C < 190 mg/dL, or with triglycerides <500mg/dL are excluded from the statement/rule above].
As per claim 15, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
the plurality of labeling functions comprises a second respective labeling function comprising a corresponding set of one or more criterion that, when satisfied, indicate an absence of the medical condition [Fig. 5, paragraph 0059 discloses a medical probabilistic rule graph comprises a plurality of nodes, medical knowledge information and a set of medical rules (not shown), wherein, “Node 1, for example, could indicate a symptom of fainting … Node 3, for example, could be the metric of high blood pressure, and Node 4, for example, could be the metric of low blood pressure … Node 5, for example, could be the diagnosis of the heart disease”; Fig. 5 shows the connections in order between nodes 1, 3, 4 and 5; Examiner interprets the medical rules comprising nodes and edges as labeling functions for the medical condition. Based on the reciting above, it can be seen that one of the medical rules including in the rule graph can be if a patient has a symptom of fainting (node 1), high blood pressure (node 3), or low blood pressure (node 4) then the patient is diagnosed with heart disease (node 5), but if the medical information of the patient is node 1008, medical metric is 1010, then the patient is not diagnosed with heart disease since there is no connection from those nodes to node 5; Fig. 17 shows an example of a criterion “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”, Fig. 17 also shows
PNG
media_image1.png
24
776
media_image1.png
Greyscale
based on the medial information above, it can be seen that the patient is not diagnosed with hyperlipidemia];
As per claim 16, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
the generating the plurality of labeling functions comprises, for the second respective labeling function:
i) defining a second set of one or more criterion that, when satisfied, indicate the absence of the medical condition [Fig. 5, paragraph 0059 discloses a medical probabilistic rule graph comprises a plurality of nodes, medical knowledge information and a set of medical rules (not shown), wherein, “Node 1, for example, could indicate a symptom of fainting … Node 3, for example, could be the metric of high blood pressure, and Node 4, for example, could be the metric of low blood pressure … Node 5, for example, could be the diagnosis of the heart disease”; Fig. 5 shows the connections in order between nodes 1, 3, 4 and 5; Fig. 5 also shows a patient that has medical knowledge information associated with node 1008, medical metrics associated with node 1010, then that patient is not diagnosed with the heart disease (absence of the medical condition)] ,
ii) determining, for each respective subject in a second subset of the first plurality of subjects, whether the corresponding medical record satisfies the second set of one or more criterion Fig. 5, paragraphs 0059-0061, discloses a medical probabilistic rule graph has a plurality of nodes comprising medical knowledge information, medical metrics, diseases, etc., wherein, the connecting between different nodes resulting in a certain disease (one of the criteria). For example, if a patient that has medical knowledge information associated with node 1008, medical metrics associated with node 1010, then that patient is diagnosed with a disease associated with node 1012],
iii) evaluating, for a respective subject in the second subset of the first plurality of subjects determined to satisfy the second set of one or more criteria whether the corresponding medical record indicates the presence of the medical condition, independent of the determination of whether the respective medical record satisfies the second set of one or more criterion [Fig. 5, paragraph 0059 discloses a medical probabilistic rule graph comprises a plurality of nodes, medical knowledge information and a set of medical rules (not shown), wherein, “Node 1, for example, could indicate a symptom of fainting … Node 3, for example, could be the metric of high blood pressure, and Node 4, for example, could be the metric of low blood pressure … Node 5, for example, could be the diagnosis of the heart disease”; Fig. 5 shows the patient medical information is evaluated to determine if the patient is diagnosed with heart disease, if a patient has a symptom of fainting (node 1), high blood pressure (node 3), or low blood pressure (node 4) then the patient is diagnosed with heart disease (node 5); Fig. 17 shows patients/individuals are evaluated based on the medical knowledge information to determine, for example if the patient or group of patients with LDL-C >= 190 mg/dL, or with triglycerides >=500mg/dL], and
iv) upon a determination that the respective medical record indicates the presence of the medical condition, revising the second set of one or more criteria to be more inclusive [Fig. 5, paragraph 0059, “Node 1, for example, could indicate a symptom of fainting … Node 3, for example, could be the metric of high blood pressure, and Node 4, for example, could be the metric of low blood pressure … Node 5, for example, could be the diagnosis of the heart disease”; Fig. 17 shows an example of a criterion “Individual with LDL-C >= 190mg/dL or triglycerides >= 500mg/dL should be evaluated for secondary causes of hyperlipidemia”].
As per claim 20, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
wherein the ensemble model comprises an aggregate voting model based on the evaluation of each respective labeling function [Fig. 1, paragraph 0039, “The flow 100 includes building a medical probabilistic rule graph 130”; paragraph 0007, “building a medical probabilistic rule graph based on the medical rules and the plurality of risk models wherein the building is based on ordering the medical rules”].
As per claim 22, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
the ensemble model comprises a probabilistic graphical model [abstract, “A medical probabilistic rule graph is built based on the medical rules and the plurality of risk models. The building of the medical probabilistic rule graph is based on ordering the medical rules. Attributes from an individual patient are applied to the medical probabilistic rule graph. A diagnosis for the individual is generated from the attributes applied to the medical probabilistic rule graph”].
As per claim 23, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
for each respective subject in the first plurality of subjects, evaluating the ensemble model comprising the plurality of labeling functions comprises evaluating a first data type for a first respective criterion in the plurality of criteria and evaluating a second data type for a second respective criterion in the plurality of criteria [Fig. 5, paragraph 0059 discloses a medical probabilistic rule graph comprises a plurality of nodes representing the medical knowledge information 510, medical metrics 520 of the patients and a set of medical rules. Fig. 5 shows multiple node connecting paths/rules, each associated with different medical information, for example, the connections in order between nodes 1, 3, 4 and 5, wherein, “Node 1, for example, could indicate a symptom of fainting … Node 3, for example, could be the metric of high blood pressure, and Node 4, for example, could be the metric of low blood pressure … Node 5, for example, could be the diagnosis of the heart disease”; paragraph 0062, “The self-learning clinical intelligence system can be based on biological information and medical knowledge information. The self-learning clinical intelligence system can include obtaining medical metrics, receiving biological information and other information from an individual, and applying the medical metrics to the biological information from the individual. The medical metrics can be applied to the biological information from the individual to diagnose an ailment, recommend a treatment”; paragraph 0041, “collecting biological information 142 from an individual. The individual can be a patient, and the biological information can include current biological information such as vital signs, notes from a previous visit to a medical practitioner, and other data. The biological information can include electronic medical records; paragraph 0059, “The medical knowledge information is structured and made consistent in a set of medical rules”; According to paragraph 0119 in the specification of the current Application that recite “the first data type is structured data (e.g., structured clinical data 42) in an electronic health record (EHR) and the second type of data is unstructured data in the EHR … unstructured data is a clinical note in the EHR.”, examiner interprets the first data type as the structure data and the second data type as the unstructured data such as notes from a previous visit to a medical practitioner].
As per claim 24, Shankar and Sanae teach the method of claim 1.
Sanae further teaches
the first data type is structured data in an electronic health record (EHR) and the second type of data is unstructured data in the EHR [paragraph 0117, “The user's health data is collected and structured into static health data and dynamic health data, as shown in FIG. 6 … Dynamic health data refers to … electronic health record (EHR) or electronic medical record (EMR) data (e.g., medications, temporary health conditions, ongoing treatments, text notes from doctors, nurses”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include the first data type is structured data in an electronic health record (EHR) and the second type of data is unstructured data in the EHR of Sanae. Doing so would help detecting a presence or absence of a disease in a patient (Sanae, 0006).
As per claim 26, Shankar and Sanae teach the method of claim 1.
Shankar teaches
natural language processing of unstructured clinical notes [paragraph 0065, “FIG. 7 illustrates natural language processing of patient data”; paragraph 0062, “The self-learning clinical intelligence system can be based on biological information and medical knowledge information. The self-learning clinical intelligence system can include obtaining medical metrics, receiving biological information and other information from an individual, and applying the medical metrics to the biological information from the individual. The medical metrics can be applied to the biological information from the individual to diagnose an ailment, recommend a treatment”; paragraph 0041, “collecting biological information 142 from an individual. The individual can be a patient, and the biological information can include current biological information such as vital signs, notes from a previous visit to a medical practitioner];
Sanae further teaches
natural language processing of unstructured clinical notes from the EHR [paragraph 0117, “The user's health data is collected and structured into static health data and dynamic health data, as shown in FIG. 6 … Dynamic health data refers to … electronic health record (EHR) or electronic medical record (EMR) data (e.g., medications, temporary health conditions, ongoing treatments, text notes from doctors, nurses”; Since Shankar teaches natural language processing of unstructured clinical notes, and Sanae teaches processing of unstructured clinical notes from the HER, therefore, the combination of Shankar and Sanae teaches the above claim limitation].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include processing of unstructured clinical notes from the EHR of Sanae. Doing so would help detecting a presence or absence of a disease in a patient (Sanae, 0006).
As per claim 31, Shankar and Sanae teach the method of claim 1.
Sanae teaches
the second information comprises at least two data types [paragraph 0006, “the method further comprises computer processing said at least said subset of said set of genomic, phenotype, or diagnostic data to detect a disease of said subject”; paragraphs 0188 and 0192, “data analytics platform may comprise one or more analytic dashboards. Different dashboards may be provided as described below, each analyzing different types of user data … advanced dashboard analyzes, predicts, and visualizes data by applying various algorithms (e.g., classification algorithms, machine learning, and pattern recognition) to a user's data. The advanced dashboard uses phenotype and genotype data to create models and predict specific features or a probability of a result, based on training data … The advanced dashboard may include one or more of … classification models as desired based on a user's data … the phenotype data comprises Electronic Health Record (EHR) data of one or more subjects (e.g., patients)”; It can be seen that the system of Sanae comprises a classification model which uses medical data that comprises at least two data types (phenotype and genotype data as input (independent variables/second information)) to predict a probability of an output (dependent variable), resulting in detecting a disease if the patient].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include the second information comprises at least two data types of Sanae. Doing so would help detecting a presence or absence of a disease in the patient and recommending a treatment for the patient (Sanae, 0006).
As per claim 39, Shankar and Sanae teach the method of claim 1.
Shankar further teaches
identifying, from a plurality of previously undiagnosed subjects, one or more respective subjects having the medical condition [paragraph 0043, “applying attributes to the medical probabilistic rule graph to generate a treatment 150 for the individual. The treatment can be recommended to a medical practitioner through a first application programming interface (not shown) and wherein the recommending of the treatment is based on machine learning factoring in previous diagnosing and recommending to other individuals of treatments with information on results of effectiveness of the treatments wherein the other individuals are associated with specific characteristics of the individual”; It can be seen that the patient who is diagnosed with a disease was a previously undiagnosed patient, since the treatments that recommending to other patients who previously diagnosing with the disease are used to recommend to the patient].
Sanae further teach
identifying, one or more respective subjects having the medical condition by inputting, for each respective subject in the plurality of subjects, corresponding second information for the respective subject into the classification model to receive as output a corresponding indication of whether the respective subject has the medical condition [paragraph 0006, “the method further comprises computer processing said at least said subset of said set of genomic, phenotype, or diagnostic data to detect a disease of said subject”; paragraphs 0188 and 0192, “data analytics platform may comprise one or more analytic dashboards. Different dashboards may be provided as described below, each analyzing different types of user data … advanced dashboard analyzes, predicts, and visualizes data by applying various algorithms (e.g., classification algorithms, machine learning, and pattern recognition) to a user's data. The advanced dashboard uses phenotype and genotype data to create models and predict specific features or a probability of a result, based on training data … The advanced dashboard may include one or more of … classification models as desired based on a user's data … the phenotype data comprises Electronic Health Record (EHR) data of one or more subjects (e.g., patients)”; It can be seen that the system of Sanae comprises a classification model which uses medical data (phenotype and genotype data as input to predict a probability of an output, to detect a disease in the patient].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include identifying, one or more respective subjects having the medical condition by inputting, for each respective subject in the plurality of subjects, corresponding second information for the respective subject into the classification model to receive as output a corresponding indication of whether the respective subject has the medical condition of Sanae. Doing so would help detecting a presence or absence of a disease in the patient and recommending a treatment for the patient (Sanae, 0006).
Claim 42 is rejected by the same reason as of claim 1, since these claims recite the similar limitations.
Shankar further teaches
A computer system [paragraph 0007, “a computer system for medical analysis”], comprising:
one or more processors [paragraph 0083, “one or more processors”]; and
a non-transitory computer-readable medium including computer-executable instructions that, when executed by the one or more processors, cause the processors to perform the method according to claim 1 [paragraph 0083, “a memory which stores instructions; one or more processors attached to the memory wherein the one or more processors, when executing the instructions which are stored, are configured to:”].
Claim 43 is rejected by the same reason as of claim 1, since these claims recite the similar limitations.
Shankar further teaches
A non-transitory computer-readable storage medium having stored thereon program code instructions that, when executed by a processor, cause the processor to perform the method according to claim 1 [paragraph 0083, “a memory which stores instructions; one or more processors attached to the memory wherein the one or more processors, when executing the instructions which are stored, are configured to:”].
Claims 37-38 are rejected under 35 U.S.C. 103 as being unpatentable over Shankar et al. in view of Sanae et al. and further in view of Moerman et al. (US Pub. 2014/0329251).
As per claim 37, Shankar and Sanae teach the method of claim 1.
Shankar and Sanae do not teach
the medical condition is pulmonary hypertension.
Moerman teaches
the medical condition is pulmonary hypertension [abstract, “methods for the diagnosis, prediction, prognosis and/or monitoring of said pulmonary injury”; paragraph 0018, “pulmonary injury with reversible damage which can lead to complications”; paragraph 0131, “The complications related to pulmonary injury may encompass pulmonary hypertension”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include the medical condition is pulmonary hypertension of Moerman. Doing so would help monitoring of diseases and conditions to recommend the treatments (Moerman, 0002).
As per claim 38, Shankar and Sanae teach the method of claim 1.
Shankar and Sanae do not teach
the medical condition is pulmonary hypertension and the second information comprises electrocardiogram results.
Moerman teaches
the medical condition is pulmonary hypertension abstract, “methods for the diagnosis, prediction, prognosis and/or monitoring of said pulmonary injury”; paragraph 0018, “pulmonary injury with reversible damage which can lead to complications”; paragraph 0131, “The complications related to pulmonary injury may encompass pulmonary hypertension” and the second information comprises electrocardiogram results [paragraph 0008, “identified LTBP2 as a new biomarker advantageous for evaluating pulmonary dysfunction, especially of predicting unfavourable lung related complications”; paragraph 0025, “the LTBP2 biomarker can be used in combination with determining clinical history, physical examination, electrocardiogram”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method for medical analysis of Shankar to include the medical condition is pulmonary hypertension and the second information comprises electrocardiogram results of Moerman. Doing so would help monitoring of diseases and conditions to recommend the treatments (Moerman, 0002).
Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Iliff (US Patent 8,337,409) describes a method for providing knowledge-based medical diagnostic advice.
Gnanasambandam et al. (US Pub. 2022/0300832) describes a method for generating cognitive data based on the structural similarity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TRI T NGUYEN whose telephone number is 571-272-0103. The examiner can normally be reached M-F, 8 AM-5 PM, (CT).
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, OMAR FERNANDEZ can be reached at 571-272-2589. 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.
/TRI T NGUYEN/Examiner, Art Unit 2128
/OMAR F FERNANDEZ RIVAS/Supervisory Patent Examiner, Art Unit 2128
Prosecution Insights