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 were previously pending and subject to a non-final Office Action having a notification date of December 16, 2025 (“non-final Office Action”). Following the non-final Office Action, Applicant filed an amendment on June 16, 2026 (the “Amendment”), amending claims 1, 2, 14, 15, and 20.
The present Final Office Action addresses pending claims 1-20 in the Amendment.
Response to Arguments
Response to Applicant’s Arguments Regarding Claim Rejections Under 35 USC §112
These rejections are withdrawn in view of the Amendment. However, new rejections are presented herein in view of the Amendment.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 5 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.
It is unclear if the "proprietary data warehouse" recited in claim 4 is the same as that recited in claim 1. The Examiner will assume they are the same for purposes of examination. The Examiner recommends amending claim 4 to recite --the proprietary data warehouse-- if Applicant agrees with the Examiner's assumption.
Claim 5 is rejected based on its dependency from rejected claim 4.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-7, 9-12, 14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0314960 to Martinez Hernandez Magro et al (hereinafter Martinez) in view of US 2018/0268937 to Spetzler et al. (hereinafter Spetzler), US 2018/0089215 to Moon (hereinafter Moon), and U.S. Patent App. Pub. No. 2010/0049546 to Neville (hereinafter Neville):
Regarding claim 1, Martinez discloses a system, comprising:
a memory that stores instructions; and
a processor that executes the instructions to perform operations ([0024] discloses a system including a processor and memory for executing instructions to perform operations), the operations comprising:
receiving, via an interface, individual search criteria associated with an individual (Fig. 8 & [0074] disclose receiving symptom description from a patient, i.e., an individual, as freeform text input (individual search criteria); Figs. 1 & 10 and [0096] & [0099] disclose that the user computer includes an input interface devices such as a keyboard)…;
generating a digital file including the individual search criteria associated with the individual ([0049] discloses that the received inputted symptoms are converted into structured data by the disease diagnosing module and [0051] discloses that the structured data is formatted in such a way that it may be compared to prior cases stored in memory, which is interpreted as generating a digital file of the individual patient’s symptoms);
formatting the digital file including the individual search criteria into a formatted digital file suitable for communication, storage, synthesis, analysis, or a combination thereof, by components of the system ([0049] discloses organizing/normalizing inputted symptoms into different categories and then transforming into structured data; also, [0051] discloses that the structured data is formatted enabling the data to be compared by the reasoning module to cases stored in memory, interpreted as being suitable for analysis by components of the system);
comparing the individual search criteria from the formatted digital file to information from a reference database ([0075]-[0078] discloses comparing the symptom description (formatted per [0051] as noted above) to data structures in one or more knowledge bases/case memory (one of which is a reference database));
identifying, based on the comparing, a potential relationship between the individual search criteria and a disease, condition, or a combination thereof, identified in the information from the reference database ([0075]-[0078] discloses how a disease identifier program identifies substantially similar data structures/solution hypotheses/cases based on the comparing (identifying potential relationships between the individual search criteria and a disease/condition/etc. in the reference database));
determining a degree of certainty of the potential relationship based on comparing the individual search criteria to aggregated information contained in a [database] ([0079]-[0082] discusses determining a numerical representation of a similarity between the symptom description and data structures (aggregated data) in one or more knowledge bases/case memory (another of which is a database/data warehouse), comparing to a threshold, and determining the hypotheses with the highest weights (greatest probabilities/degrees of certainty); also, [0083] discusses determining a confidence interval (degree of certainty) indicating degree of confidence that a diagnosis is correct based on cases stored in case memory (aggregated information contained in a data warehouse/database);
generating, by utilizing an electronic visualization tool, an interactable digital image that visualizes the potential relationship between the individual search criteria and the disease, the condition, or a combination thereof, (Fig. 8 and [0082] disclose providing/displaying the potential disease diagnosis to the user, described above as being the patient/individual, which includes a digital representation, i.e., a visualization, on a client device including a display as described in Fig. 10 & [0099] by utilizing a driver 1030, Fig. 7C and [0082] disclose the presented visualization may include a generated graph tree as depicted in Fig. 7C and discussed further in [0073]. The presented visualization is interactable because at a minimum the user views it, further [0035] & [0039]-[0040] disclose that the disease identifier tool is interactive. The DI tool in combination with the driver is interpreted as being the visualization tool in line with Applicant’s Specification [0037])…
presenting the potential relationship… via the interactable digital image on a visualization interface on a device associated with the individual (as noted above, the potential relationship is presented on a visualization interface on a device associated with the user);
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However, Martinez appears to be silent regarding the individual search criteria including a genomic signature associated with the individual, biochemical information associated with the individual, or a combination thereof; the interactable digital image including at least one first interactable digital block; and the operations further including
digitally layering, as part of a simulation for simulating the disease, the condition, or a combination thereof, associated with the potential relationship, the at least one first interactable digital block outwards from a center of the interactable digital image such that each successive interactable digital block extending outwards beyond the at least one first interactable digital block has progressively more specific characteristics associated with the potential relationship between the individual search criteria and the disease, the condition, or a combination thereof;
processing a selection of the at least one first interactable digital block of the interactable digital image, wherein the selection is performed based on an interaction conducted with the at least one first interactable digital block of the interactable digital image;
adjusting the interactable digital image and the at least one first interactable digital block in real-time as the individual search criteria changes and based on the interaction conducted with the interactable digital image; and
generating, based on the interactable digital image and automatically in response to the selection of the at least one first interactable digital block of the interactable digital image, a sub-interactable digital image having at least one second interactable digital block, wherein the sub-interactable digital image is digitally layered outwards such that each successive interactable block of the sub-interactable digital image extending outwards beyond the at least one second interactable digital block has progressively more specific characteristics than the characteristics associated with the at least one first interactable digital block of the interactable image corresponding to the selection, wherein the sub-interactable digital image, digital layering of the sub-interactable digital image, and the at least one second interactable digital block are adjusted as the individual search criteria changes and based on interaction conducted with the interactable digital image, the sub-interactable digital image, or a combination thereof.
Nevertheless, Spetzler teaches that it was known in the healthcare informatics art to identify relationships between a biological sample/biomarker/individual search criteria (e.g., using gene expression analysis per [0028], [0092]) of a patient and a disease/condition ([0089]), and display a GUI including GUI objects associated with the patient data and relationships that provide a visualization for analyzing biological data ([0107]), where a first “sunburst” GUI/interactable digital image (Figure 4N and [0137]) includes digital objects/blocks 406H/408H/etc. that are digitally layered outwards from a center of the interactable digital image such that each successive interactable digital block extending outwards beyond a first interactable digital block has progressively more specific characteristics associated with the potential relationship between the individual search criteria (e.g., the biological sample/biomarker) and the disease/condition.
Spetzler also discloses how a user can manipulate/interact with the GUI image and the objects/blocks to visually compare the target patient against reference patients to increase the likelihood of a positive outcome and/or patient status ([0109]), such that the GUI image would “adjust” based on the interaction with the GUI image (which is interpreted to be in substantially “real-time” because the system is computer-implemented). Automatically updating/adjusting the digitally layered objects/blocks is considered to be a simulation for simulating the disease/condition consistent with [0042] of Applicant’s specification which discusses updating the sunburst as part of a real-time simulation.
Still further, [0143]-[0146] of Spetzler discloses how in response to receipt of updated patient data, the updated patient data can be mapped, staged, combined, and transformed to prepare the data for querying/searching and analysis by a clinician using the computing device 502, while [0142] notes how the device 502 can be user device 100A, and [0083], [0084], and [0107] notes how the user device 100A includes the user interface for displaying GUI images for visualizing and analyzing patient data as noted above. Accordingly, in response to a search for updated data (changing individual search criteria) being received and processed as noted above, the clinician can visualize and analyze the updated patient data via the GUI images (e.g., of Figures 4N-4O) which would involve an adjustment of such GUI images to incorporate the updated patient data. Therefore, in conjunction with both a search for updated patient data (changing individual search criteria) and user interaction with the GUI image as noted above (e.g., for comparing target patients to reference patients), the GUI image adjusts (which is interpreted to be in substantially “real-time” because the system is computer-implemented). Furthermore, updating of the GUI image based on the changing search criteria would include updating the GUI object/blocks based on such changing search criteria (e.g., including the first interactable digital block).
Spetzler also discloses how in response to a selection of a particular object/block in the GUI image (e.g., of block 408H in Figure 4N, based on an interaction with/a manipulation of the block), an intermediate sunburst GUI image including a second interactable object/block is generated (Figure 4O and [0140] showing block 410H (second interactable object/block), where each successive interactable object/block (e.g., block 412H) of the intermediate GUI image extending outwards past the second interactable object/block (e.g., block 410H) has progressively more specific characteristics than characteristics associated with the first interactable digital block of the GUI image corresponding to the selection (e.g., because third block 412H has specific characteristics of second block 410H which in turn has specific characteristics of first block 408H, then third block 412H (and blocks therebeyond) has progressively more specific characteristics associated with the first interactable digital block).
Furthermore, and similar to as discussed in relation to the GUI image of Figure 4N in the preceding paragraph, the intermediate GUI image of Figure 4O (e.g., including the digital layering and second interactive digital object block thereof) adjusts (which is interpreted to be in substantially “real-time” because the system is computer-implemented) in conjunction with both a search for updated patient data (changing individual search criteria) and user interaction with the GUI image and/or intermediate GUI image (e.g., for comparing target patients to reference patients) as noted above. This arrangement advantageously allows healthcare practitioners to assess patient diseases/conditions and potential treatment options in an efficient/intuitive manner to increase the likelihood of a positive outcome and/or patient status ([0109]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the individual search criteria to include a genomic signature and/or biochemical information associated with the individual, and for the operations to further include i) digitally layering, as part of a simulation for simulating the disease/condition associated with the potential relationship, interactable digital blocks of the interactable digital image outward from a center of the image such that each successive interactable digital block extending outwards beyond a first interactable digital block has progressively more specific characteristics associated with the potential relationship between the individual search criteria and the disease/condition; ii) processing a selection of the first interactable digital block based on an interaction conducted with the first interactable digital block; iii) adjusting the interactable digital image and the at least one first interactable digital block in real-time as the individual search criteria changes and based on the interaction conducted with the interactable digital image; and iv) generating, based on the interactable digital image and automatically in response to the selection of the first interactable digital block, a sub-interactable digital image having at least one second interactable digital block, wherein the sub-interactable digital image is digitally layered outwards; wherein the sub-interactable digital image, digital layering of the sub-interactable digital image, and the at least one second interactable digital block are adjusted as the individual search criteria changes and based on interaction conducted with the interactable digital image, the sub-interactable digital image, or a combination thereof in the system of Martinez as taught by Spetzler to advantageously allow healthcare practitioners to assess patient diseases/conditions and potential treatment options in an efficient/intuitive manner to increase the likelihood of a positive outcome and/or patient status. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
While Spetzler discloses how third block 412H extending outward past the second block 410H has more specific characteristics of the first block 408H as discussed above, Spetzler might not specifically disclose each successive interactable block of the sub-interactable digital image extending outwards beyond the at least one second interactable digital block has progressively more specific characteristics associated with the at least one first interactable digital block of the interactable image corresponding to the selection. In other words, to the extent that “each successive interactable block of the sub-interactable digital image extending outwards beyond the at least one second interactable digital block” connotes a plurality of blocks extending outward past the second block, Spetzler might be silent.
Nevertheless, Moon teaches ([0013]-[0014], claim 7, and Figure 3) that it was known in the interactive user interface art to present a sunburst chart that displays hierarchically arranged information including layered concentric arc elements that extend outwardly from a root, whereby selection of one of the elements generates a new sunburst chart whereby the selected element is a new root and each layered concentric arc radiating from the root includes child elements of the new root. For instance, as the sunburst chart of Figure 3 illustrates about 10 radiating concentric arcs, then selection of the third concentric arc from the center would generate another sunburst chart including the fourth concentric arc and a plurality of radiating/successive blocks extending outwardly from the fourth concentric arc. This arrangement advantageously allows a user to drill a desired object/block to receive more detailed information specific to the desired object/block to thereby improve analytical decision-making and the like.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for each successive interactable block of the sub-interactable digital image extending outwards beyond the at least one second interactable digital block to have progressively more specific characteristics than characteristics associated with the at least one first interactable digital block of the interactable image corresponding to the selection in the system of the Martinez/Spetzler as taught by Moon to advantageously allow a user to drill a desired object/block to receive more detailed information specific to the desired object/block to thereby improve analytical decision-making and the like and because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Finally, while Martinez already discloses presenting/displaying the potential relationship/potential disease to a user and also determining the degree of certainty of the potential relationship/potential disease as discussed above, Martinez might be silent regarding the data warehouse used to determine the degree of certainty to be a proprietary data warehouse and specifically presenting the degree of certainty of the potential relationship via the digital image on the interface of the device.
Nevertheless, Neville teaches ([0096]-[0103], [0237], [0233]) that it was known in the healthcare informatics art to determine probabilities of a plurality of diseases of a patient based on information in a private internal/proprietary database and display the probabilities which advantageously supports accurate diagnosis of the patient and facilitates initiation of appropriate courses of medical treatment ([0259]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the data warehouse used to determine the degree of certainty to be a proprietary data warehouse and to present the degree of certainty of the potential relationship via the digital image on the interface of the device in the system of Martinez as taught by Neville to advantageously support accurate diagnosis of the patient and facilitate initiation of appropriate courses of medical treatment. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 2, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including wherein the aggregated information in the proprietary warehouse comprises information corresponding to a plurality of individuals, a plurality of conditions, a plurality of scientific research data, a plurality of medical data, any type of data, or a combination thereof (Martinez - [0078]-[0083] discloses how the probabilities/weights/confidence levels are determined based on data structures/cases/etc. ("aggregated data," which is "any type of data") in the data warehouse (proprietary per the combination with Neville)).
Regarding claim 3, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including periodically querying the reference database and downloading relevant health data for future analyses to be conducted based on the individual search criteria, future individual search criteria, or a combination thereof (Martinez - [0040] & [0042] disclose users may submit queries, i.e., periodically, that reference the database as discussed above in claim 1 and further disclose storing (downloading) the determined disease diagnosis for future diagnostic case use, i.e., future analyses based on future search criteria).
Regarding claim 4, the Martinez/Spetzler/Moon combination discloses the system of claim 1, further including updating [the] proprietary data warehouse by aggregating the individual search criteria, information associated with the potential relationship, information associated with an analysis conducted by the system on the potential relationship, metadata associated with the individual search criteria, or a combination thereof, with existing information in the proprietary data warehouse to generate updated data (Martinez - [0057]-[0058] discloses updating the knowledge bases/case memory (one of which is the "data warehouse" as noted above in relation to claim 1, and which is "proprietary" per the above combination with Neville) by adding new descriptive symptom elements (information associated with potential relationship and/or metadata associated with the individual search criteria) and/or latest scientific/empirical data (information associated with potential relationship) to information already in the database/knowledge base/case memory (existing information) to generate "updated data").
Regarding claim 5, the Martinez/Spetzler/Moon combination discloses the system of claim 4, further including wherein the operations further comprise formatting the updated data for future re-use in additional system data analysis by-products (while Martinez might not specifically disclose the updated data (from [0057]-[0058]) to be formatted, Martinez already discloses ([0049], [0051]) that the input symptom data is formatted enabling the data to be compared by the reasoning module to cases stored in memory; therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have also formatted the updated data of Martinez similar to as already taught by Martinez to advantageously allow the updated data to be analyzed in view of inputted symptom data to determine potential diagnoses, degrees of certainty, etc., thereby supporting medical diagnoses by medical professionals).
Regarding claim 6, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including wherein the individual search criteria comprises a keyword, a search term, any type of criteria, a filter, or a combination thereof (Martinez - [0074] discloses that the search criteria is a symptom, interpreted as “any type of criteria”).
Regarding claim 7, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including detecting [an issue] associated with the individual based on comparing the individual search criteria from the formatted digital file to the information from the reference database (Martinez - Fig. 8, [0051] & [0078]-[0082] discloses detecting an issue, e.g., a disease, associated with the individual based on comparing the individual search criteria from the formatted digital file to the information from the reference database; furthermore, Spetzler discloses ([0015], [0040], [0091]) how it was known in the healthcare informatics art to identify DNA biomarkers such as mutations/variants (genetic anomalies) to advantageously assist in the detection of a disease/condition and determination of appropriate treatment options ([0002]); therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the issue of Martinez to have been a genetic anomaly as taught by Spetzler to advantageously assist in the detection of a disease/condition and determination of appropriate treatment options; A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Regarding claim 9, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including wherein the operations further comprise determining a preventive action for mitigating or preventing the disease, the condition, or a combination thereof, associated with the potential relationship (claims 34, 37, and 38 and [0109] of Spetzler disclose determining a therapeutic regime (preventative action) for providing patient care (mitigating/preventing the disease/condition) based on the relationships; similar to as discussed previously, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have determined a preventive action for mitigating or preventing the disease, the condition, or a combination thereof, associated with the potential relationship in the system of Martinez as taught by Spetzler to advantageously allow healthcare practitioners to assess patient diseases/conditions and potential treatment options in an efficient/intuitive manner to increase the likelihood of a positive outcome and/or patient status. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 10, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including conducting the simulation for simulating the disease, the condition, or a combination thereof, associated with the potential relationship ([0109] of Spetzler discloses how a user can manipulate/interact with the GUI image and the objects/blocks to visually compare the target patient against reference patients to increase the likelihood of a positive outcome and/or patient status ([0109]), such that the GUI image would “adjust” based on the interaction with the GUI image (which is interpreted to be in substantially “real-time” because the system is computer-implemented); automatically updating/adjusting the digitally layered objects/blocks is considered to be a simulation for simulating the disease/condition consistent with [0042] of Applicant’s specification which discusses updating the sunburst as part of a real-time simulation; similar to as discussed previously, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have conducted the simulation for simulating the disease, the condition, or a combination thereof, associated with the potential relationship in the system of Martinez as taught by Spetzler to advantageously allow healthcare practitioners to assess patient diseases/conditions and potential treatment options in an efficient/intuitive manner to increase the likelihood of a positive outcome and/or patient status. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 11, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 10, further including visually presenting the simulation to the individual via the visualization interface ([0109] of Spetzler discloses how a user can manipulate/interact with the GUI image and the objects/blocks to visually compare the target patient against reference patients to increase the likelihood of a positive outcome and/or patient status ([0109]), such that the GUI image would “adjust” based on the interaction with the GUI image (which is interpreted to be in substantially “real-time” because the system is computer-implemented); automatically updating/adjusting the digitally layered objects/blocks is considered to be a simulation for simulating the disease/condition consistent with [0042] of Applicant’s specification which discusses updating the sunburst as part of a real-time simulation; similar to as discussed previously, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have visually presented the simulation to the individual via the visualization interface in the system of Martinez as taught by Spetzler to advantageously allow healthcare practitioners to assess patient diseases/conditions and potential treatment options in an efficient/intuitive manner to increase the likelihood of a positive outcome and/or patient status. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Regarding claim 12, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including wherein the operations further comprise providing the potential relationship, an analysis of the potential relationship, the individual search criteria, metadata associated with the search criteria, or a combination thereof, to a device associated with a health professional for further analysis (Martinez - [0037] & [0040] discloses that results of disease identifications are validated by subject matter experts, interpreted as providing at least the potential relationship, Martinez - [0047] discloses that the subject matter expert is a doctor, i.e., a health professional).
Claim 14 is rejected in view of the Martinez/Spetzler/Moon/Neville combination as discussed above in relation to claim 1.
Regarding claim 18, the Martinez/Spetzler/Moon/Neville combination discloses the method of claim 14, further including enhancing a search algorithm, an analytics algorithm, or a combination thereof, utilized by the system based on the potential relationship, the individual search criteria, metadata associated with the potential relationship, metadata associated with the individual search criteria, or a combination thereof (Martinez - Fig. 9 and [0040] disclose using the diagnosis hypothesis, i.e., the potential relationship, in updating and improving performance of future diagnosis by presenting the diagnosis hypothesis to a subject matter expert who marks it as a success/failure which is then used to update the medical artificial intelligence analytics application, interpreted as an analytics algorithm).
Regarding claim 19, the Martinez/Spetzler/Moon/Neville combination discloses the method of claim 14, further including predicting an outcome associated with the individual based on the potential relationship identified ([0019] of Spetzler discloses providing a prognosis (predicted outcome) based on the one or more interrelationships to assist in providing care; similar to as discussed previously, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have predicted an outcome associated with the individual based on the potential relationship identified in the system of Martinez as taught by Spetzler to advantageously allow healthcare practitioners to assess patient diseases/conditions and potential treatment options in an efficient/intuitive manner to increase the likelihood of a positive outcome and/or patient status. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
Claim 20 is rejected in view of the Martinez/Spetzler/Moon/Neville combination as discussed above in relation to claim 1.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0314960 to Martinez Hernandez Magro et al (hereinafter Martinez) in view of US 2018/0268937 to Spetzler et al. (hereinafter Spetzler), U.S. Patent App. Pub. No. 2018/0089215 to Moon (hereinafter Moon), and US 2010/0049546 to Neville (hereinafter Neville), and further in view of US 2021/0043326 to Janssen (hereinafter Janssen):
Regarding claim 8, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including initiating … monitoring of the individual based on the potential relationship identified ([0012] and [0025] of Spetzler discuss processing patient data that tracks patient status (e.g., condition/disease) over time, where the condition/disease is based on the identified relationships per [0089]; therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have initiated monitoring of the individual based on the potential relationship identified in the system of Martinez as taught by Spetzler to advantageously allow healthcare practitioners to assess patient diseases/conditions and potential treatment options in an efficient/intuitive manner to increase the likelihood of a positive outcome and/or patient status. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.).
However, the Martinez/Spetzler/Moon/Neville combination appears to be silent regarding the monitoring being performed in real-time.
Nevertheless, Janssen teaches that it was known in the healthcare informatics art to initiate real-time monitoring of an individual based on a potential relationship identified ([0058] teaches that based upon a diagnosis, lab result, etc, i.e., an identified relationship, that monitoring of the patient is initiated; [0090] teaches that the monitoring is done continuously, interpreted as in real-time).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the monitoring of the Martinez/Spetzler/Moon/Neville combination to be in real-time as taught by Janssen in order to appropriately allocate monitoring devices to patients in need, e.g., see Janssen [0020]. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0314960 to Martinez Hernandez Magro et al (hereinafter Martinez) in view of US 2018/0268937 to Spetzler et al. (hereinafter Spetzler), U.S. Patent App. Pub. No. 2018/0089215 to Moon (hereinafter Moon), and US 2010/0049546 to Neville (hereinafter Neville), and further in view of US 2008/0194928 to Bandic et al (hereinafter Bandic):
Regarding claim 13, the Martinez/Spetzler/Moon/Neville combination discloses the system of claim 1, further including conducting disease/condition simulations ([0109] of Spetzler discloses how a user can manipulate/interact with the GUI image and the objects/blocks to visually compare the target patient against reference patients to increase the likelihood of a positive outcome and/or patient status, such that the GUI image would “adjust” based on the interaction with the GUI image (which is interpreted to be in substantially “real-time” because the system is computer-implemented). Automatically updating/adjusting the digitally layered objects/blocks is considered to be a simulation for simulating the disease/condition consistent with [0042] of Applicant’s specification which discusses updating the sunburst as part of a real-time simulation).
However, the Martinez/Spetzler/Moon/Neville combination appears to be silent regarding specifically conducting a simulation of an outbreak, a population shift in health, an age progression, a disease progression, a condition progression, or a combination thereof.
Nevertheless, Bandic teaches (Figure 6 and [0081]) that it was known in the healthcare informatics art to generate and output a simulation of a progression of a condition to the user via a user interface (condition/disease progression) in order to enable visualization of the effect of a condition progression with and without treatment.
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare systems before the effective filing date of the claimed invention to conduct a condition/disease progression simulation in the system of the Martinez/Spetzler/Moon/Neville combination as taught by Bandic to advantageously enable visualization of the effect of a condition progression with and without treatment thereby improving patient health outcomes. A person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. Id.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0314960 to Martinez Hernandez Magro et al (hereinafter Martinez) in view of US 2018/0268937 to Spetzler et al. (hereinafter Spetzler), U.S. Patent App. Pub. No. 2018/0089215 to Moon (hereinafter Moon), and US 2010/0049546 to Neville (hereinafter Neville), and further in view of US 2019/0295696 to Yang et al (hereinafter Yang):
Regarding claim 15, the Martinez/Spetzler/Moon/Neville combination discloses the method of claim 14, further including updating the database of an artificial intelligence system of the system based on the potential relationship, the individual search criteria, metadata associated with the potential relationship, metadata associated with the individual search criteria, or a combination thereof (Martinez - [0040] discloses updating the database of the artificial intelligence system with the determined diagnosis hypothesis, i.e., the potential relationship, data that has been validated).
However, the Martinez/Spetzler/Moon/Neville combination might be silent regarding updating the database of the artificial intelligence system to include training an artificial intelligence system of the system, a machine learning system of the system, or a combination thereof.
Nevertheless, Yang teaches ([0053]) that it was known in the healthcare informatics art for updating a database to include training a classifier of a machine learning system in order to improve the accuracy of recommendations ([0004]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention for the updating of the AI system in the Martinez/Spetzler/Moon/Neville combination to include training an artificial intelligence system of the system, a machine learning system of the system, or a combination thereof as taught by Yang in order to improve the accuracy of recommendations and because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0314960 to Martinez Hernandez Magro et al (hereinafter Martinez) in view of US 2018/0268937 to Spetzler et al. (hereinafter Spetzler), U.S. Patent App. Pub. No. 2018/0089215 to Moon (hereinafter Moon), and US 2010/0049546 to Neville (hereinafter Neville), and further in view of US 2019/0295696 to Yang et al (hereinafter Yang) and US 2010/0179827 to McCallie, Jr et al (hereinafter McCallie):
Regarding claim 16, the Martinez/Spetzler/Moon/Neville combination discloses the method of claim 14, further including using the individual search criteria to generate a feedback loop into the system to update the artificial intelligence system of the system (Martinez - [0040] discloses updating the database of the artificial intelligence system with the diagnosis hypothesis determined from the individual search criteria of inputted symptoms, i.e., information, updating a database with results of search criteria is interpreted as generating a feedback loop into the AI system).
However, the Martinez/Spetzler/Moon/Neville combination appears to be silent regarding resetting the individual search criteria to generate a feedback loop into the system so as to train an artificial intelligence system of the system, a machine learning system of the system, or a combination thereof.
Nevertheless, Yang teaches ([0053]) that it was known in the healthcare informatics art to collect information into the system so as to train an artificial intelligence system of the system, a machine learning system of the system, or a combination thereof ([0053] teaches training the machine learning system based on newly collected information, e.g., when a threshold number of new records has been collected) in order to improve the accuracy of recommendations ([0004]).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare before the effective filing date of the claimed invention collect information into the system so as to train an artificial intelligence system of the system, a machine learning system of the system, or a combination thereof in the system of the Martinez/Spetzler/Moon/Neville combination as taught by Yang in order to improve the accuracy of recommendations and because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Furthermore, McCallie teaches that it was old and well known in the art of healthcare systems, before the effective filing date of the claimed invention, to collect additional information by resetting the individual search criteria ([0081] teaches that the result interface includes a query reset button to allow a new query, including new individual search criteria, to be submitted, i.e., so additional information can be collected by the system).
Therefore, it would have been obvious to one of ordinary skill in the art of healthcare systems before the effective filing date of the claimed invention to modify the query system disclosed by the Martinez/Spetzler/Moon/Neville/Yang combination to incorporate collecting additional information by resetting the individual search criteria as taught by McCallie in order to enable a new search to be performed by a user(s) and because a person of ordinary skill in the art would have been motivated to combine the prior art to achieve the claimed invention and there would have been a reasonable expectation of success in doing so." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007). The courts have made clear that the teaching, suggestion, or motivation test is flexible and an explicit suggestion to combine the prior art is not necessary. The motivation to combine may be implicit and may be found in the knowledge of one of ordinary skill in the art, or, in some cases, from the nature of the problem to be solved. DyStar Textilfarben GmbH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1360, 80 USPQ2d 1641, 1645 (Fed. Cir. 2006). Furthermore, all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0314960 to Martinez Hernandez Magro et al (hereinafter Martinez) in view of US 2018/0268937 to Spetzler et al. (hereinafter Spetzler), U.S. Patent App. Pub. No. 2018/0089215 to Moon (hereinafter Moon), and US 2010/0049546 to Neville (hereinafter Neville), and further in view of US 2020/0357526 to Odiz et al (hereinafter Odiz):
Regarding claim 17, the Martinez/Spetzler/Moon/Neville combination discloses the method of claim 14, further including using machine learning and artificial intelligence to analyze and determine the disease diagnosis using the disease identifier program which compares the individual search criteria to the information from the reference database (e.g., see Martinez - [0039] & [0074] and as discussed above in claim 1).
However, the Martinez/Spetzler/Moon combination might not specifically disclose executing the machine learning and artificial intelligence system to perform the comparison to utilize a mathematical algorithm.
Nevertheless, Odiz teaches ([0045]) that it was old and well known in the art of healthcare diagnosis artificial intelligence systems, before the effective filing date of the claimed invention, to use an artificial intelligence based algorithm, i.e., at least one mathematical algorithm to make a comparison between received data and a database to determine a disease category.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art at the time of the invention was made for the machine learning and artificial intelligence system of the Martinez/Spetzler/Moon/Neville combination to specifically be an artificial intelligence based algorithm, i.e., a mathematical algorithm as taught by Odiz because the combination of the two references is merely simple substitution of one known element for another producing a predictable result (KSR rationale B). Because each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself—that is, in the substitution of the artificial intelligence based algorithm, i.e., a mathematical algorithm, of the secondary reference Odiz for the artificial intelligence of the primary reference, Martinez. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/JONATHON A. SZUMNY/Primary Examiner, Art Unit 3686
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