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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/11/2026 has been entered.
Response to Amendment
This action is in response to the amendment filed on 06/11/2026. Claims 1 and 19-22 are amended, and claim 2 was previously canceled. Claims 1 and 3-22 are examined below.
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 and 3-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claim 1 recites (additional limitations crossed out):
A medical information processing apparatus comprising:
acquire examination data including examination values of a plurality of types of biological examinations performed on the same subject at a plurality of time points;
determine, for each type of biological examination, a relationship between an examination value and a risk level, including whether the risk level increases or decreases relative to the examination value;
convert the examination values of the plurality of types of biological examinations into normalized risk values within a predetermined numerical range based on the determined relationships, so that the normalized risk values represent risk levels on a common scale regardless of differences in the relationships;
create a map based on the normalized risk values, the map including a plurality of time-series element groups in which a plurality of elements corresponding to the biological examinations performed at the plurality of time points and having a visual representation according to the normalized risk values are arranged in a time-series order along a first direction; and
wherein, in the map, the plurality of time-series element groups corresponding to the plurality of types of biological examinations are arranged along a second direction different from the first direction.
The above limitations, as drafted, are processes that, under their broadest reasonable interpretation, is a process that, under its broadest reasonable interpretation covers managing personal behavior or relationships or interactions between people, as well as functions that may be performed mentally or with pen and paper. That is, other than reciting the claims as being performed by “processing circuitry”, nothing in the claims precludes the steps as being described as managing personal behavior or relationships or interactions between people, and functions that may be performed mentally or with pen and paper. The claims, as written describe receiving examination data, determining a relationship between an examination value and a risk level, converting examination values into normalized risk values, and creating a map based on the normalized risk values (i.e., drawing a graph), and displaying the map. If a claim limitation, under its broadest reasonable interpretation, describes managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activities” grouping of abstract ideas. Further, if a claim limitation, under its broadest reasonable interpretation, describes functions that may be performed mentally or with pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of “processing circuitry” to perform the steps. However, these additional elements are recited at a high level of generality (see at least Para. [0019]) such that they amount to no more than mere instructions to apply the exception using generic computing components. The claims also feature the limitation “control a display unit to display the map”. However, this is merely insignificant extra-solution activity. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are therefore still directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of “processing circuitry” to perform the claimed steps amounts to no more mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept. Further, the limitation “control a display unit to display the map” does not amount to significantly more than the judicial exception because it is a well-understood, routine and conventional function. The Examiner takes Official Notice that the display of data via a user interface is a well-understood, routine, and conventional function since it has been prevalent in the art for decades (i.e., since the advent of computers with monitors). The performance of conventional functions by generic computers does not provide an inventive concept. Therefore, the claims are not found to be patent eligible.
Claims 21 and 22 feature limitations similar to those of claim 1, and are also found to be directed to an abstract idea without significantly more.
Claims 3-20 are dependent on claim 1, and include all the limitations of claim 1. Claims 3, 6-8, 10, 11, 16, and 18 feature “control the display to display…” particular data. However, again, this is merely extra-solution activity, and the display of data is a conventional function as evidenced by the reasoning previously stated. The remaining limitations of the dependent claims have not been found to integrate the judicial exception into a practical application, or provide significantly more than the abstract idea since they merely further narrow the abstract idea (e.g., type of data displayed). Therefore, the dependent claims are found to be directed to an abstract idea without significantly more.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 6-8, 12, and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Individual health-disease phase diagrams for disease prevention based on machine learning” by Kazuki Nakamura, available online on July 17, 2023, hereinafter referred to as Nakamura1, in view of Jacobs (US 11,324,469) and “Functional Heatmap: an automated and interactive pattern recognition tool to integrate time with multi-omics assays” by Joshua Williams, available February 15, 2019, hereinafter referred to as Williams2.
Regarding claim 1, Nakamura partially discloses A medical information processing apparatus comprising: processing circuitry configured to
acquire examination data including examination values of biological examinations performed on the same subject at a plurality of time points;
determine, for each type of biological examination, a relationship between an examination value and a risk level, including whether the risk level increases or decreases relative to the examination value;
convert the examination values of the plurality of types of biological examinations into normalized … values within a predetermined numerical range based on the determined relationships, so that the normalized … values represent … levels on a common scale regardless of differences in the relationships;
create a map … the map including a time-series element group in which a plurality of elements corresponding to the biological examinations performed at the plurality of time points and having a visual representation according to a degree of risk are arranged in a time-series order along a first direction; and
(See page 2 – “In this study, we propose a health-disease phase diagram (HDPD) that represents an individual’s health status at each time point by visualizing the boundary values of multiple biomarkers that fluctuate early in the progression process of NCDs.”, page 4 – “For biomarkers for which a lower value is a risk factor, the upper limit that induced onset prediction in the HDPDs was analyzed to investigate whether even high values could induce disease-onset prediction. First, we determined the upper limit of the biomarker value that induces disease-onset prediction for each value of another biomarker in HDPD. When all biomarker values induced a non-onset prediction, the minimum value in the HDPD was acquired as the upper limit. Subsequently, the range of the upper limit values was retrieved for each record. For biomarkers for which a high value is a risk factor, the lower limit was analyzed by the same procedure.”, page 5 – “Higher immunoglobulin A (IgA) levels were associated with a higher risk in the HDPDs of IgA and total cholesterol (Fig. 3a–b). High serum IgA levels may reflect the involvement of IgA nephropathy, which is a common cause of CKD [35]. Some HDPDs exhibited no personal boundaries, whereas others displayed non-linear personal boundaries. Additionally, there were cases in which the known knowledge and risk value were reversed up and down, such as total cholesterol (Fig. 3a). Even for the same participant, the personal boundaries in the HDPDs changed over time (Fig. 3c). In this example, a clinically valid combination of decreased eGFR and increased blood glucose level forms a boundary in the direction of onset. Before and after the baseline year (X + 2), when the participant entered the future-onset area, the actual measured values of eGFR and blood glucose showed fluctuations in the surrounding area. The personal boundaries also changed annually, depending on the state of the other parameters, indicating changes in the target values in the intervention.”. Also see legend of Fig. 3 which indicates that the color pink is associated with Onset, while the color blue is associated with Non-onset. The Examiner asserts that said Onset and Non-onset equates to normalized risk values. However, while heavily implied due to the use of machine learning, Nakamura does not explicitly disclose “a medical information processing apparatus comprising: processing circuitry” See at least Jacobs, Claim 10 – “processing device configured with processor executable instructions to perform operation comprising”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura to utilize the teachings of Jacobs since it may allow data of Nakamura to be processed faster.
Nakamura does not explicitly disclose converting the examination values of the plurality of types of biological examinations into normalized risk values within a predetermined numerical range. Nakamura instead converts the examination values as either Onset (pink) or Non-onset (blue). The Examiner asserts that the risk values being numerical is simply a label for the risk values and adds little, if anything, to the claimed acts or steps and thus does not serve to distinguish over the prior art. Any differences related merely to the meaning and information conveyed through labels (i.e., the type of values) which does not explicitly alter or impact the steps of the method (i.e., converting examination values to normalized risk values) does not patentably distinguish the claimed invention from the prior art in terms of patentability. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of invention to have the onset/non-onset values (i.e., risk values) of Nakamura be numerical because the format of the risk value does not functionally alter or relate to the steps of the method and merely labeling the risk value differently from that of the prior art does not patentably distinguish the claimed invention.
Nakamura does not explicitly disclose control a display unit to display the map. (While Nakamura features several figures displaying the certain biomarker measurements and their associated risk of disease (see at least Figs. 3-5), Nakamura does not explicitly disclose the display of said figures on a display unit. See Jacobs, Col. 2, Lines 22-23 – “The heatmap can also be outputted to a graphical user interface.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura to utilize the teachings of Jacob since it would allow for the digital display of the determined information of Nakamura.)
Nakamura does not fully disclose wherein, in the map, the plurality of time-series element groups corresponding to the plurality of types of biological examinations are arranged along a second direction different from the first direction. Nakamura features clinical results (i.e., biological examinations) on a separate axis from time periods (see at least Fig. 3c which features Blood Glucose vs Year X, X+1, etc., or Fig. 4c). However, Nakamura does not feature a plurality of types of biological examinations. See Williams page 1 – “Functional Heatmap offers time-series data visualization through a Master Panel page, and Combined page to answer each of the three time-series questions. It dissects the complex multi-omics time-series readouts into patterned clusters with associated biological functions.”, page 3 – “Users may notice that there are many miscellaneous applications for Functional Heatmap besides genetics. These include multi-dimensional continuous time-series data from biological analytes (protein, metabolite, microbiome, etc.), financial data, or engineering data.”, and Fig2c – “Shows the gene expression heatmaps split out by tissue”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura to utilize the teachings of Williams since it would allow users to identify a cascade of functional changes over a time variable (Page 1).
Regarding claim 6, Nakamura discloses The medical information processing apparatus according to claim 1, wherein the processing circuitry is further configured to
extract a type of biological examination associated with a designated subtype or drug, (See at least Page 7 – “Hierarchically clustered heatmap for feature contribution to HDPDs among records. The feature contribution to HDPDs was calculated as the proportion of the HDPDs where the variable contributed to the personal boundary.”, Page 8 – “Additionally, the biomarker values defining personal boundaries were analyzed for the dominant biomarkers in the onset prediction models. For the biomarkers with the highest feature importance in each disease prediction model, the value that yielded disease-onset prediction at the furthest value from the abnormal values was extracted based on the HDPD for each record (Fig. 5b).”, and Fig. 3.)
Nakamura does not explicitly disclose control the display to display the extracted type of biological examination. (While Nakamura features several figures displaying the graphical relationships, Nakamura does not explicitly disclose the display of said figures on a display unit. See Jacobs, Col. 2, Lines 22-23 – “The heatmap can also be outputted to a graphical user interface.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura to utilize the teachings of Jacob since it would allow for the digital display of the determined information of Nakamura.)
Regarding claim 7, Nakamura discloses The medical information processing apparatus according to claim 6, wherein the processing circuitry is further configured to
rearrange the plurality of time-series element groups so that time-series element groups corresponding to the extracted biological examination are grouped, (See at least Page 7 – “Hierarchically clustered heatmap for feature contribution to HDPDs among records. The feature contribution to HDPDs was calculated as the proportion of the HDPDs where the variable contributed to the personal boundary.”, and Fig. 3e.)
Nakamura does not explicitly disclose control the display to display the map including the plurality of rearranged time-series element groups. (While Nakamura features several figures displaying the graphical relationships, Nakamura does not explicitly disclose the display of said figures on a display unit. See Jacobs, Col. 2, Lines 22-23 – “The heatmap can also be outputted to a graphical user interface.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura to utilize the teachings of Jacob since it would allow for the digital display of the determined information of Nakamura.)
Regarding claim 8, Nakamura does not explicitly disclose The medical information processing apparatus according to claim 1, wherein the processing circuitry is further configured to control the display to display medical-related information related to one or a plurality of elements selected among the plurality of elements constituting the map. (While Nakamura features several figures displaying the graphical relationships (see at least Fig. 4), Nakamura does not explicitly disclose the display of said figures on a display unit. See Jacobs, Col. 2, Lines 22-23 – “The heatmap can also be outputted to a graphical user interface.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura to utilize the teachings of Jacob since it would allow for the digital display of the determined information of Nakamura. The Examiner asserts that “medical-related information related to one or a plurality of elements” may be interpreted as any data related to the elements as information related to “biological examination” is “medical-related”.)
Regarding claim 12, Nakamura discloses The medical information processing apparatus according to claim 8, wherein the medical-related information is a graph of an examination value of a biological examination corresponding to one or the plurality of selected elements. (See at least Page 7 – “Hierarchically clustered heatmap for feature contribution to HDPDs among records. The feature contribution to HDPDs was calculated as the proportion of the HDPDs where the variable contributed to the personal boundary.”, and Fig. 3e.)
Regarding claim 19, Nakamura discloses The medical information processing apparatus according to claim 1, wherein the map is a heat map, and the visual representation is color. (See at least Page 7 – “Hierarchically clustered heatmap for feature contribution to HDPDs among records. The feature contribution to HDPDs was calculated as the proportion of the HDPDs where the variable contributed to the personal boundary.”, and Fig. 3e.)
Regarding claim 20, Nakamura discloses The medical information processing apparatus according to claim 1, wherein the visual representation is mark or pattern. (See at least Page 7 – “Hierarchically clustered heatmap for feature contribution to HDPDs among records. The feature contribution to HDPDs was calculated as the proportion of the HDPDs where the variable contributed to the personal boundary.”, and Fig. 3e.)
Claims 21-22 feature limitations similar to those of claim 1, and are therefore rejected using the same rationale.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Individual health-disease phase diagrams for disease prevention based on machine learning” by Kazuki Nakamura, available online on July 17, 2023, hereinafter referred to as Nakamura, in view of Jacobs (US 11,324,469) and “Functional Heatmap: an automated and interactive pattern recognition tool to integrate time with multi-omics assays” by Joshua Williams, available February 15, 2019, hereinafter referred to as Williams, and in further view of “How to Create a Heatmap” by James Mott, available January 28, 2023, hereinafter referred to as Mott3
Regarding claim 3, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 1, wherein the processing circuitry is further configured to:
rearrange the plurality of time-series element groups based on a sorting index, and
control the display to display the map including the plurality of rearranged time-series element groups.
(See Mott – “Select how you would like to sort the data in the table by selecting Sort by averages (ascending) or Sort by averages (descending). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Nakamura, Jacobs, and Williams to utilize the teachings of Mott it provides options in how data may be presented.”)
Regarding claim 4, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 3, wherein the sorting index is risk order, by subtype, or by drug. (See Mott – “Select how you would like to sort the data in the table by selecting Sort by averages (ascending) or Sort by averages (descending). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Nakamura, Jacobs, and Williams to utilize the teachings of Mott it provides options in how data may be presented. The Examiner asserts that the sorting index being by risk order, by subtype, or by drug is simply a label for the sorting and adds little, if anything, to the claimed acts or steps and thus does not serve to distinguish over the prior art. Any differences related merely to the meaning and information conveyed through labels (i.e., the particular manner in which data is sorted) which does not explicitly alter or impact the steps of the method (i.e., sorting data) does not patentably distinguish the claimed invention from the prior art in terms of patentability. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of invention to have the system of Nakamura, Jacobs, and Mott sort data by risk order, by subtype, or by drug because the manner in which the data is sorted does not functionally alter or relate to the steps of the method and merely labeling the sorting index differently from that of the prior art does not patentably distinguish the claimed invention.)
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Individual health-disease phase diagrams for disease prevention based on machine learning” by Kazuki Nakamura, available online on July 17, 2023, hereinafter referred to as Nakamura, in view of Jacobs (US 11,324,469), “Functional Heatmap: an automated and interactive pattern recognition tool to integrate time with multi-omics assays” by Joshua Williams, available February 15, 2019, hereinafter referred to as Williams and “How to Create a Heatmap” by James Mott, available January 28, 2023, hereinafter referred to as Mott, and in further view of “Excel Charts – three methods for filtering Chart Data” by Chris Menard, available February 25, 2021, hereinafter referred to as Menard4.
Regarding claim 5, Nakamura, Jacobs, Williams, and Mott do not explicitly disclose The medical information processing apparatus according to claim 4, wherein in a case in which the sorting index is risk order, the processing circuitry is further configured to rearrange the plurality of time-series element groups in an order of risk determined from examination values at a reference time point, the reference time point being either (i) a latest examination time point in the examination data, or (ii) a user-designated examination time pointe (While Mott teaches sorting data; see Mott – “Select how you would like to sort the data in the table by selecting Sort by averages (ascending) or Sort by averages (descending).”, Mott does not explicitly disclose the data being associated with a particular time point (i.e., latest time point or designated time point). Menard teaches the filtering of displayed data associated with particular dates. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the system of Nakamura, Jacobs, Williams, and Mott to utilize the teachings of Menard since it provides even further options in how data may be presented.)
Claim(s) 9-11, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Individual health-disease phase diagrams for disease prevention based on machine learning” by Kazuki Nakamura, available online on July 17, 2023, hereinafter referred to as Nakamura, in view of Jacobs (US 11,324,469) and “Functional Heatmap: an automated and interactive pattern recognition tool to integrate time with multi-omics assays” by Joshua Williams, available February 15, 2019, hereinafter referred to as Williams, and in further view of Miller (US 2004/0066957).
Regarding claim 9, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 8, wherein the medical-related information is a medical image captured at the same time point as the biological examination of the selected element. (See Miller, Para. [0007] – “The graphical user interface further displays graphs or curves providing data related to the ultrasound images. Each data point on the curves represents one ultrasound image frame of the ultrasound image sequence. When the user selects, e.g., by clicking using a mouse, a particular data point on a curve of a graph, the corresponding ultrasound image is displayed by the graphical user interface.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Miller are in the same field of endeavor (i.e., presentation of medical data), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 10, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 9, wherein the processing circuitry is further configured to cause the display unit to display an enlarged image of a region of interest indicated by output data of a learned model or by user annotation in the medical image and/or an image finding based on the medical image. (See Miller, Para. [0117] – “With reference to FIG. 2, there is shown an exemplary screen 50 of the graphical user interface 20. The screen 50 includes time, patient and other data 52 on a top portion, a large frozen or paused playback image 54 of the myocardium, a vertical scale 56 along the right side of the image 54, a bits per minute (BPM) signal 58 below the image 54, a CINELOOP.TM. thumbnail display 60, image review control soft buttons 62 (e.g., reverse, forward and play/pause, speed control, jump to first frame, frame step forward, jump to image of interest forward, jump to last frame, frame step backward, jump back to image of interest), a graph 63 displaying time intensity and one-minus-exponential curves 64a, 64b below the CINELOOP.TM. image 60, a first group of soft buttons 66 for at least adjusting the contrast of the image 54, selecting at least one region of interest (ROI) on the image 54, enlarging the image 54, moving the image 54, and zooming in and out with respect to the image 54, and a second group of soft buttons 68 for at least adjusting the position of the graph 63 displaying the curves 64a, 64b, and zooming in and out with respect to the graph 63 displaying the curves 64a, 64b.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Miller are in the same field of endeavor (i.e., presentation of medical data), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 11, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 9, wherein the processing circuitry is further configured to control the display to perform display for each examination time point, of an indicator of a presence or an absence of a corresponding medical image. (See Miller, Para. [0007] – “The graphical user interface further displays graphs or curves providing data related to the ultrasound images. Each data point on the curves represents one ultrasound image frame of the ultrasound image sequence. When the user selects, e.g., by clicking using a mouse, a particular data point on a curve of a graph, the corresponding ultrasound image is displayed by the graphical user interface.” The displaying of the image equates to “an indicator of a presence or absence of a corresponding medical image”. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Miller are in the same field of endeavor (i.e., presentation of medical data), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 16, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 1, wherein the processing circuitry is further configured to control the display to display a medical image captured at a time point selected from the plurality of time points. (See Miller, Para. [0007] – “The graphical user interface further displays graphs or curves providing data related to the ultrasound images. Each data point on the curves represents one ultrasound image frame of the ultrasound image sequence. When the user selects, e.g., by clicking using a mouse, a particular data point on a curve of a graph, the corresponding ultrasound image is displayed by the graphical user interface.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Miller are in the same field of endeavor (i.e., presentation of medical data), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 17, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 16, wherein the medical image is a mammography image, an ultrasound image, a CT image, or an MRI image. (See Miller, Para. [0007] – “The graphical user interface further displays graphs or curves providing data related to the ultrasound images. Each data point on the curves represents one ultrasound image frame of the ultrasound image sequence. When the user selects, e.g., by clicking using a mouse, a particular data point on a curve of a graph, the corresponding ultrasound image is displayed by the graphical user interface.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Miller are in the same field of endeavor (i.e., presentation of medical data), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 18, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 16, wherein the processing circuitry is further configured to control the display unit to display an enlarged image of a region of interest indicated by output data of a learned model or by user annotation in the medical image and/or an image finding based on the medical image. (See Miller, Para. [0117] – “With reference to FIG. 2, there is shown an exemplary screen 50 of the graphical user interface 20. The screen 50 includes time, patient and other data 52 on a top portion, a large frozen or paused playback image 54 of the myocardium, a vertical scale 56 along the right side of the image 54, a bits per minute (BPM) signal 58 below the image 54, a CINELOOP.TM. thumbnail display 60, image review control soft buttons 62 (e.g., reverse, forward and play/pause, speed control, jump to first frame, frame step forward, jump to image of interest forward, jump to last frame, frame step backward, jump back to image of interest), a graph 63 displaying time intensity and one-minus-exponential curves 64a, 64b below the CINELOOP.TM. image 60, a first group of soft buttons 66 for at least adjusting the contrast of the image 54, selecting at least one region of interest (ROI) on the image 54, enlarging the image 54, moving the image 54, and zooming in and out with respect to the image 54, and a second group of soft buttons 68 for at least adjusting the position of the graph 63 displaying the curves 64a, 64b, and zooming in and out with respect to the graph 63 displaying the curves 64a, 64b.” It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Miller are in the same field of endeavor (i.e., presentation of medical data), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Individual health-disease phase diagrams for disease prevention based on machine learning” by Kazuki Nakamura, available online on July 17, 2023, hereinafter referred to as Nakamura, in view of Jacobs (US 11,324,469) and “Functional Heatmap: an automated and interactive pattern recognition tool to integrate time with multi-omics assays” by Joshua Williams, available February 15, 2019, hereinafter referred to as Williams, and in further view of Axtell (US 2025/0189541).
Regarding claim 13, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 8, wherein the medical-related information is a fluorescence microscopic image or a co-localization Venn diagram of a biological examination corresponding to one or the plurality of selected elements. (See Axtell, Para. [0018] – “FIGS. 6A to 6D show that a panel of serum proteins classifies MS relapse with higher accuracy than NFL alone. (FIG. 6A) Venn diagram comparing significantly abundant proteins between MS relapse and remission from OMRF and Stanford cohort. (FIG. 6B).”, and Fig. 6A. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Axtell since Nakamura, Jacobs, and Axtell are in the same field of endeavor (i.e., presentation of medical data), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The Examiner further asserts that the “medical-related information” being a fluorescence microscopic image or a co-localization Venn diagram of a biological examination corresponding to one or the plurality of selected elements. is simply a label for the medical-related information and adds little, if anything, to the claimed acts or steps and thus does not serve to distinguish over the prior art. Any differences related merely to the meaning and information conveyed through labels (i.e., the particular medical-related information) which does not explicitly alter or impact the steps of the method (i.e., displaying medical-related information) does not patentably distinguish the claimed invention from the prior art in terms of patentability. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of invention to have the system of Nakamura, Jacobs, and Axtell display fluorescence microscopic image or a co-localization Venn diagram of a biological examination corresponding to one or the plurality of selected elements because the particular type of data displayed does not functionally alter or relate to the steps of the method and displaying data different from that of the prior art does not patentably distinguish the claimed invention.
Claim(s) 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over “Individual health-disease phase diagrams for disease prevention based on machine learning” by Kazuki Nakamura, available online on July 17, 2023, hereinafter referred to as Nakamura, in view of Jacobs (US 11,324,469) and “Functional Heatmap: an automated and interactive pattern recognition tool to integrate time with multi-omics assays” by Joshua Williams, available February 15, 2019, hereinafter referred to as Williams, and in further view of Hall (US 11,205,265).
Regarding claim 14, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 8, wherein the medical-related information is a score calculated based on examination data of a biological examination corresponding to one or the plurality of selected elements. (See Hall, Col. 4, Lines 54-67 and Col. 5, Lines 1-2 – “As shown, in step 162, the procedure 160 inputs one or more types of mammography imagery 172 from the patient; for example, 2D FFDM images, 3D tomosynthesis volumes, and/or 2D synthetic images. The system uses this image data to compute a range of CAD features (numerical values as described below) 174. The system (for example, via interface 152) can input optional data 176 related to the patient, including, but not limited to, (a) the age of patient, (b) lifestyle familial factors, (c) polygenic (DNA based) risk factors/scores ( e.g. as described in the above-referenced Karolinska study), and/or (d) breast density. In step 164 of the overall procedure 160, the system and method herein computes accurate short term, and long-term risks scores 178 ( as also described further below) using the input information from step 162.,” and Fig. 1B. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Hall are in the same field of endeavor (i.e., determination of health risk), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The Examiner further asserts that the “medical-related information” being a score calculated based on examination data of a biological examination corresponding to one or the plurality of selected elements. is simply a label for the medical-related information and adds little, if anything, to the claimed acts or steps and thus does not serve to distinguish over the prior art. Any differences related merely to the meaning and information conveyed through labels (i.e., the particular medical-related information) which does not explicitly alter or impact the steps of the method (i.e., displaying medical-related information) does not patentably distinguish the claimed invention from the prior art in terms of patentability. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of invention to have the system of Nakamura, Jacobs, and Axtell display a score calculated based on examination data of a biological examination corresponding to one or the plurality of selected elements because the particular type of data displayed does not functionally alter or relate to the steps of the method and displaying data different from that of the prior art does not patentably distinguish the claimed invention.
Regarding claim 15, Nakamura, Jacobs, and Williams do not explicitly disclose The medical information processing apparatus according to claim 8, wherein the medical-related information is an integrated score calculated based on examination data of a biological examination corresponding to one or the plurality of selected elements and a medical image captured at a same time point as the biological examination. (See Hall, Col. 4, Lines 54-67 and Col. 5, Lines 1-2 – “As shown, in step 162, the procedure 160 inputs one or more types of mammography imagery 172 from the patient; for example, 2D FFDM images, 3D tomosynthesis volumes, and/or 2D synthetic images. The system uses this image data to compute a range of CAD features (numerical values as described below) 174. The system (for example, via interface 152) can input optional data 176 related to the patient, including, but not limited to, (a) the age of patient, (b) lifestyle familial factors, (c) polygenic (DNA based) risk factors/scores ( e.g. as described in the above-referenced Karolinska study), and/or (d) breast density. In step 164 of the overall procedure 160, the system and method herein computes accurate short term, and long-term risks scores 178 ( as also described further below) using the input information from step 162.,” and Fig. 1B. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Nakamura, Jacobs, and Williams to utilize the teachings of Miller since Nakamura, Jacobs, and Hall are in the same field of endeavor (i.e., determination of health risk), and all of 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 would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The Examiner further asserts that the “medical-related information” being an integrated score calculated based on examination data of a biological examination corresponding to one or the plurality of selected elements and a medical image captured at the same time point as the biological examination. is simply a label for the medical-related information and adds little, if anything, to the claimed acts or steps and thus does not serve to distinguish over the prior art. Any differences related merely to the meaning and information conveyed through labels (i.e., the particular medical-related information) which does not explicitly alter or impact the steps of the method (i.e., displaying medical-related information) does not patentably distinguish the claimed invention from the prior art in terms of patentability. Therefore, it would have been obvious to a person of ordinary skill in the art at the time of invention to have the system of Nakamura, Jacobs, and Axtell display an integrated score calculated based on examination data of a biological examination corresponding to one or the plurality of selected elements and a medical image captured at the same time point as the biological examination because the particular type of data displayed does not functionally alter or relate to the steps of the method and displaying data different from that of the prior art does not patentably distinguish the claimed invention.
Response to Arguments
Applicant's arguments regarding claims rejected under 35 U.S.C. 101 have been fully considered but they are not persuasive:
Applicant argues again that acquiring information is not an abstract idea. The Examiner points to MPEP 2106.04(a)(2)(III) – “In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. Examples of claims that recite mental processes include: …a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011);”
Applicant argues that the creating step cannot be performed in the mind and that “the human mind is not equipped to process such large amounts of data and generate the map shown”. This is not persuasive. The claims make no mention of particular amounts of data. Further, the generation of the map may be performed with pen and paper.
Applicant argues that the reference that the processing circuitry is recited at a “high level of generality” is improper. This is not persuasive. Per the Applicant’s own specification, the processing circuitry is a generic computing component (Para. [0019]) that is used to perform the abstract functions.
Applicant repeated argument that the claims are analogous to Ex parte Desjardins, and that the claims provide significantly more than the abstract idea are not persuasive as the claims do not provide a technical improvement As previously stated, the claims merely present data in a particular format and this has no impact on the functioning capabilities of the medical information processing apparatus.
Applicant’s argument concerning the patentability of the Jacobs reference is not persuasive as the reference featured a different fact pattern.
Based on at least the above, the 101 rejection is maintained.
Applicant's arguments regarding claims rejected under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant argues with substance:
Applicant argues that Nakamura does not disclose the determining and converting steps recited in claim 1. This is not persuasive, as these limitations are addressed in the updated rejection above.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the motivation for combining was provided in the body of the rejection above.
Applicant’s arguments concerning the invention yielding unpredictable technical results is not persuasive, as this is not a consideration in the novelty of the invention.
Based on at least the above, the 103 rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
“Global patterns of prognostic biomarkers across disease space” by Neha Murad5
“Heat map visualization of complex environmental and biomarker measurements” by Joachim Pleil6
Thadhani (US 2007/0111245)
All of the above demonstrate the use of heatmaps in displaying biomarker data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE G ROBINSON whose telephone number is (571)272-9261. The examiner can normally be reached Monday - Thursday, 7:00 - 4:30 EST; Friday 7:00-11:00 EST.
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, Kambiz Abdi can be reached at 571-272-6702. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE G ROBINSON/Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685
1 Available at https://www.sciencedirect.com/science/article/pii/S1532046423001697?via%3Dihub#s0125
2 Available at https://pmc.ncbi.nlm.nih.gov/articles/PMC6377781/
3 Available at https://web.archive.org/web/20230128201028/https://help.qresearchsoftware.com/hc/en-us/articles/4407140054543-How-to-Create-a-Heatmap
4 Available at https://www.youtube.com/watch?v=SEBTzu5b1NE
5 Available at https://www.nature.com/articles/s41598-022-25209-y
6 Available at https://www.sciencedirect.com/science/article/pii/S0045653511002864
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