Detailed Notice
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-20 and 23-29 are currently pending.
Claims 1-20 and 23-29 are rejected.
Claims 1-8, 11, 13-14, 17-18, 20, 23, and 25-27 are amended.
Claims 21-22 are canceled.
Claim 29 is new.
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 1-20 and 23-29 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.
Step 1:
In the instant case, claims 1-6 and 23-29 are directed toward a method (i.e. process) and claims 7-12 are directed toward a non-transitory media (i.e., manufacture), and claim 13-20 is directed toward a system (i.e., machine). Thus, each of the claims falls within one of the four statutory categories. Nevertheless, the claims fall within the judicial exception of an abstract idea.
Step 2A—Prong 1:
Independent claims 1, 7, and 13 recites steps that, under their broadest reasonable interpretations, cover performance of the limitations of a certain method of organizing human activity and/or mental process but for the recitation of generic computer components.
Claim 1 recites: “A method-performed by one or more hardware processors (OOMHPs), the method comprising: receiving, via the OOMHPs and at a medical records computer system associated with an electronic memory, a first set of physiological variables associated with an individual as input data from a first electronic health record system of a plurality of disparate electronic health record systems having different ontologies; mapping, via the OOMHPs, the first set of physiological variables to a second set of physiological variables corresponding to a second electronic health record system of the plurality of disparate electronic health record systems; determining, via (the OOMHPs a multi-variable (MV) biomarker based at least on a the second set of physiological variables, wherein determining the MV biomarker comprises transforming values of the second set of physiological variables into intermediate values and creating a composite variable based on the intermediate values; generating, via the OOMHPs, a machine-learning electronic model, wherein generating the machine-learning electronic model comprises reducing a dimensionality of a set of candidate input variables by: (a) utilizing training data, comprising MV biomarker instances and one or more decision elements associated with the MV biomarker instances, to condition coefficients of a support vector machine until a training output is within a predetermined error threshold; and (b) selecting from the set of candidate input variables a subset of the set of candidate input variables that is statistically significantly associated with a clinically significant glycogen storage (CSGS) disease, wherein the subset comprises a plurality of myalgia, comorbidity, creatine kinase, red blood cell size distribution width, aminotransferases, alanine aminotransferase to aspartate aminotransferase ratio, erythrocyte microcytosis, anion gap, or hypothyroidism; accepting a classifier generated by the support vector machine as a candidate for logistic regression in response to a receiver operating characteristic of the classifier satisfying a first threshold, and otherwise repeating the reducing with an adjusted selection of the set of candidate input variables; determining, at the OOMHPs, a probability of (the CSGS) disease for the individual by applying the machine- learning electronic model to the MV biomarker to generate information indicating the probability of the CSGS disease; electronically writing, via the OOMHPs, electronic encoded data to the electronic memory at the medical records computer system, wherein the electronic encoded data indicates the probability of the CSGS disease; and based on the probability of the CSGS disease satisfying a second threshold, automatically initiating via the OOMHPs an intervention action, wherein the intervention action comprises automatically initiating, via the OOMHPs, an electronic health record transaction at the medical records computer system concerning the probability of the CSGS disease”.
The limitations of receiving, a first set of physiological variables associated with an individual as input data… having different ontologies; mapping, the first set of physiological variables to a second set of physiological variables; determining, a multi-variable (MV) biomarker based at least on a the second set of physiological variables, wherein determining the MV biomarker comprises transforming values of the second set of physiological variables into intermediate values and creating a composite variable based on the intermediate values; generating, by: (a) utilizing training data, comprising MV biomarker instances… associated with the MV biomarker instances, to condition coefficients… until a training output is within a predetermined error threshold; and (b) selecting from the set of candidate input variables a subset of the set of candidate input variables that is statistically significantly associated with a clinically significant glycogen storage (CSGS) disease, wherein the subset comprises a plurality of myalgia, comorbidity, creatine kinase, red blood cell size distribution width, aminotransferases, alanine aminotransferase to aspartate aminotransferase ratio, erythrocyte microcytosis, anion gap, or hypothyroidism; accepting a classifier… as a candidate for logistic regression in response to a receiver operating characteristic of the classifier satisfying a first threshold, and otherwise repeating the reducing with an adjusted selection of the set of candidate input variables; determining, a probability of (the CSGS) disease for the individual by… generate information indicating the probability of the CSGS disease; indicates the probability of the CSGS disease; and based on the probability of the CSGS disease satisfying a second threshold, automatically initiating an intervention action, wherein the intervention action comprises automatically initiating, an electronic health record transaction… concerning the probability of the CSGS disease, given the broadest reasonable interpretation, cover the abstract idea of a certain method of organizing human activity because they recite managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions—in this case the aforementioned steps recite a process of receiving, generating, mapping, determining, selecting, utilizing, satisfy, generating, and initiating, which is properly interpreted as a “personal behavior”), and/or a mental process that a doctor/nurse/clinician/person would perform to diagnose or treat a person with CSGS disease via mentally/in the mind or with a pen and paper, but instead automates the process via a computer model, e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements”, and will be discussed in further detail below.
Further, the abstract idea of claims 7 and 13 are identical as the abstract idea of claim 1. This limitation, given the broadest reasonable interpretation, also falls under the abstract idea of a certain method of organizing human activity because it recites managing personal behavior or relationships or interactions between people. Additionally, the limitations may also fall under the abstract idea of a mental process because a doctor would perform to diagnose or treat a person with CSGS disease via mentally/in the mind or with a pen and paper.
Dependent claims 2-6, 8-12, 14-20. And 23-29 include other limitations, as well as specific step of data to be processed, received, and applied, but these only serve to further limit the abstract idea and do not add and additional elements, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claims 1, 7, and 13. However, recitation of an abstract idea is not the end of the 35 U.S.C. 101 analysis. Each of the claims must be analyzed for additional elements that indicate the abstract idea is integrated into a practical application to determine whether the claim is considered to be “directed to” an abstract idea.
Step 2A—Prong 2:
Claims 1-20 and 23-29 are not integrated into a practical application because the additional elements (i.e. any limitations that are not identified as part of the abstract idea) amount to no more than limitations which:
Amount to mere instructions to apply an exception—for example, the recitation of “hardware processors (OOMHPs)”, “electronic health record system”, “machine-learning electronic model”, “decision elements”, “support vector machine”, “electronic memory”, “medical records computer system”, “electronic encoded data”, and “non-transitory media”, which amount to merely invoking a computer as a tool to perform the abstract idea, e.g. see FIG. 1A, FIG. 1B, [0013]-[0017] of the present specification, and see further MPEP 2106.05(f);
Generally linking the abstract idea to a particular technological environment or field of use, for example, “via the OOMHPs and at a medical records computer system associated with an electronic memory”, “from a first electronic health record system of a plurality of disparate electronic health record systems”, “via the OOMHPs”, “corresponding to a second electronic health record system of the plurality of disparate electronic health record systems”, “via the OOMHPs”, “via the OOMHPs, a machine-learning electronic model, wherein generating the machine-learning electronic model comprises reducing a dimensionality of a set of candidate input variables by”, “and one or more decision elements”, “of a support vector machine”, “generated by the support vector machine”, “at the OOMHPs”, “applying the machine-learning electronic model to the MV biomarker to”, “electronically writing, via the OOMHPs, electronic encoded data to the electronic memory at the medical records computer system, wherein the electronic encoded data”, “via the OOMHPs,” “via the OOMHPs”, “at the medical records computer system”, and “One or more non-transitory media having computer-readable instructions that, when executed by one or more hardware processors (OOMHPs), cause the OOMHPs to facilitate a plurality of operations, the operations comprising”, which amounts to limiting the abstract idea to the field of technology/the environment of computers, see MPEP 2106.05(h); and/or
Merely acquiring information for further analysis by the system and the particular manner of acquisition is not described or shown to be important, for example, “receiving, via the OOMHPs and at a medical records computer system associated with an electronic memory, a first set of physiological variables associated with an individual as input data from a first electronic health record system of a plurality of disparate electronic health record systems having different ontologies”, which amounts to insignificant extra-solution activity in the form of mere data gathering because it merely functions tangentially to the main idea of the invention and serves only to bring in the data necessary for the inventions main analysis, see MPEP 2106.05(g).
Additionally, dependent claims 2-6, 8-12, 14-20 and 23-29 include other limitations, but as stated above, the limitations recited by these claims do not include any additional elements beyond those already recited in independent claims 1, 7, and 13, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B:
The claims do not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the elements other than the abstract idea), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, which even when reevaluated under the considerations of Step 2B of the analysis, do not amount to “significantly more” than the abstract idea.
Dependent claims 2-6, 8-12, 14-20 and 23-29 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent claims 1, 7, and 13, and hence do not amount to “significantly more” than the abstract idea.
Additionally, the additional elements (i.e., “receiving, via the OOMHPs and at a medical records computer system associated with an electronic memory, a first set of physiological variables associated with an individual as input data from a first electronic health record system of a plurality of disparate electronic health record systems having different ontologies”), add extra solution activity, which comprises limitations which amount to elements that have been recognized as well-understood, routine, and conventional activity in a particular field as demonstrated by:
Relevant court decisions (See MPEP 2106.05(d)(II)):
Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) (“Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink.” (emphasis added)).
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation.
Therefore, whether taken individually or as an ordered combination, claims 1-20 and 23-29 are nonetheless rejected under 35 U.S.C. 101 as being directed to non-statutory subject matter.
Response to Arguments
Applicant's arguments filed 07/30/2026 have been fully considered. Regarding the 35 U.S.C. 112(a) rejection, the amendments to the claims resolve the new matter issues. Therefore, the 112(a) rejection is withdrawn.
Regarding the 35 U.S.C. 101 rejection, Applicant argues the claims do not recite an abstract idea, more specifically that there is no basis for a certain method of organizing human activity abstract idea grouping. Applicant also argues that there is now inclusion of similar limitations from the parent application which was allowed. Applicant also argues that the claims must recite, define, and describe an influencing of human activity, however the claims recite microprocessor activity and automation via machines.
Examiner respectfully disagrees. The claims as a whole are directed to an activity of a person and computer tools (see MPEP 2106.04(a)(2) states “the sub-groupings encompass both activity of a single person (for example, a person following a set of instructions or a person signing a contract online) and activity that involves multiple people (such as a commercial interaction), and thus, certain activity between a person and a computer (for example a method of anonymous loan shopping that a person conducts using a mobile phone) may fall within the “certain methods of organizing human activity” grouping”). It is also noted, the claims could also recite the abstract idea of a mental process, as shown in MPEP 2106.04(a)(2), which states “Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures “can be carried out in existing computers long in use, no new machinery being necessary.” 409 U.S at 67, 175 USPQ at 675. See also Mortgage Grader, 811 F.3d at 1324, 117 USPQ2d at 1699 (concluding that concept of “anonymous loan shopping” recited in a computer system claim is an abstract idea because it could be “performed by humans without a computer”)”. The claims recite initiating an intervention of ordering a diagnostic test which under broadest reasonable interpretation recite, define, and describe an influencing of human activity. Additionally, the automation using microprocessors or other such computer tools is not part of the abstract idea, but additional elements, which was addressed in prong 2. Furthermore, the inclusion of elements from the parent case to present application, although encouraging, does not make the application 101 eligible by default, as the analysis of 101 has evolved since the admittance of the parent applications.
Applicant argues the claims recite an improvement in a technical field. Applicant also argues the claims recite an improvement similar to CardioNet in reducing a patient’s risk, reducing underdiagnosis, applying an electronic predictive model to patient information to determined risk level, etc.
Examiner respectfully disagrees. The improvements the Applicant described are not technical improvements to the additional elements, but improvements to the abstract idea (see MPEP 2106.05(f): “Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, “claiming the improved speed or efficiency inherent with applying the abstract idea on a computer” does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015)” and MPEP 2106.05(a) states “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018))”).
Applicant argues the claims are directed to a practical application by building a unique data structure and similar to Example #47, claim 3.
Examiner respectfully disagrees. Claim 3 of Example #47 was eligible because the claims reflected an improvement in the technical field of network intrusion detection. Limitations (d)-(f) provide an improved network security using the information from the detection to enhance security. The current application does not recite similar improvements of network intrusion detection, nor is it similar in concept.
Applicant argues in Step 2B the office did not recite or provide citation that the claims are well-known, routine, or conventional.
Examiner respectfully disagrees. As stated above, the additional elements are recited at a high level such that they amount to computer tools that merely apply or link the abstract idea to (see MPEP 2106.05(f)). Furthermore, the Office Action has clear citations to court cases and to areas of the MPEP as needed per Berkheimer in the Step 2B analysis. Therefore, the 35 U.S.C. 101 Rejection is maintained.
Conclusion
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/R.S.S./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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