Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Response to Amendment
In the Office Action dated 17 July 2026, the following occurred:
Claims 1-3, 7-15, 18-20, 25-32, 36, and 38 are amended.
Claims 1-40 are pending.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(I). The following figures are unsatisfactory for reproduction because they are blurry:
Fig. 1, 4, 4A, 4B, 4C, 4D
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 36 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 36 is rejected because it is unclear and thus indefinite. Claim 36 recites “the first client computing device and the second client computing device comprise a single computing device.” It is unclear how two different devices (distinguished by “first” and “second”) can comprise only a single device between the two of them.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 36 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The combining of the first and second client computing devices broadens the claim rather than narrowing it. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 1 and 18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claims recite systems and methods for displaying patient data relating to chronic diseases, and therefore meet step 1.
Step 2A1
The limitations of (Claim 18 being representative) maintaining a framework for categorizing time series patient data into one of a plurality of possible categories useful for managing patients with one or more chronic health conditions; receiving… time series patient data spanning over a total time period, the time series patient data comprising a plurality of patient variables over time, and the total time period covering an entire patient history; dividing the total time period into a plurality of time intervals; for each patient variable for each time interval of the plurality of time intervals, analyzing the time series patient data of the time interval using the framework to produce a category of the plurality of possible categories; generating graphic data… to display, for each patient variable for each time interval, a visual indication of the category for the time interval, wherein the visual indication comprises a discretized representation generated from the patient variable for the time interval; wherein the visual indications for a patient variable across the plurality of time intervals are displayed simultaneously to permit visualization of a progression of the patient variable across the entire patient history; wherein selection of a visual indication corresponding to a patient variable and a time interval causes display of underlying patient data associated with the patient variable and the time interval; wherein each respective visual indication is selectable… to cause display of underlying patient data used to produce the category represented by the respective visual indication; and transmitting… the graphic data…, as drafted, is a process that, under the broadest reasonable interpretation, falls in the grouping of certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. The claims encompass a series of rules or instructions for a person or persons to follow, with or without the aid of a computer, to display patient data (see Spec. Para. 0004 describing managing complex patients as a human activity) in the manner described in the identified abstract idea, supra. The rules or instructions are the claimed steps of “maintaining… dividing… analyzing… and generating…” as indicated supra.
Other than reciting generic computer components (discussed infra), i.e., a method for execution by a server (computer), the claimed invention amounts to managing personal behavior or interaction between people (i.e., a person or persons following rules or instructions to collect, display and transmit data). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people (i.e., rules or instructions for a person or persons to follow) but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A2
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements of a server, a first client computing device, and a second client computing device that implement the identified abstract idea. The computing devices are not described by the applicant and are recited at a high-level of generality (i.e., any appropriate client computing device, many possibilities for the server) such that they amount to no more than mere instructions to apply the exception using generic computer components. See MPEP 2106.05(f). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
The claim further recites the additional elements of (1) receiving time series patient data and (2) transmitting the graphic data. Each of these steps are recited at a high level of generality and amounts to the mere transmission of data, which is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
The claim further recites the additional element of a graphical user interface. The graphical user interface merely generally links the abstract idea to a particular technological environment or field of use. MPEP 2106.04(d)(I) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide a practical application.
Step 2B
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a server and client computing devices to perform the noted steps amounts to no more than 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 (“significantly more”).
As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (1) receiving time series patient data and (2) transmitting the graphic data were considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field. MPEP 2016.05(d)(II) indicates that receiving and/or transmitting data over a network has been held by the courts to be well-understood, routine, conventional activity (citing Symantec, TLI Communications, OIP Techs., and buySAFE). Well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). As such the claim is not patent eligible.
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional element of a graphical user interface was determined to generally link the abstract idea to a particular technological environment or field of use. This has been re-evaluated under the “significantly more” analysis and has also been found insufficient to provide significantly more. MPEP 2106.05(A) indicates that generally linking an abstract idea to a particular technological environment or field of use cannot provide significantly more. As such the claim is not patent eligible.
Claims 2-17 and 19-40 are similarly rejected because they either further define/narrow the abstract idea and/or do not further limit the claim to a practical application or provide as inventive concept such that the claims are subject matter eligible even when considered individually or as an ordered combination.
Claims 2 and 19 merely describe the plurality of possible categories, which further defines the abstract idea.
Claims 3 and 20 merely describe the first and second modalities of the bimodal representation, which further defines the abstract idea.
Claims 4 and 21 merely describe the bimodal representation, which further defines the abstract idea.
Claims 5 and 22 merely describe the first and second colors, which further defines the abstract idea.
Claims 6 and 23 merely describe providing a visual representation, which further defines the abstract idea.
Claims 7-15 merely describe the patient variables, which further defines the abstract idea.
Claims 16, 17, 33, and 34 merely describe each time variable, which further defines the abstract idea.
Claims 24-32 merely describe the one or more chronic health conditions, which further defines the abstract idea.
Claims 35 and 36 merely describe the first client computing device, which further defines the abstract idea.
Claim 37 merely describes implementing claim 18, which further defines the abstract idea.
Claim 37 also includes the additional elements of “a non-transitory computer readable medium” and “a processor” which are analyzed the same as the “server” and do not provide a practical application or significantly more for the same reasons.
Claims 38-40 merely describe the server, which further defines the abstract idea.
Claim 38 also includes the additional elements of “a network adapter,” “a network,” and “variable categorization circuitry” which are analyzed the same as the “server” and do not provide a practical application or significantly more for the same reasons.
Claim 38 further recites the additional element of “one or more client computing devices” which are analyzed the same as the first and second client computing devices and do not provide a practical application or significantly more for the same reasons.
Claim 39 also includes the additional elements of “variable categorization circuitry,” “a processor,” and “a non-transitory computer readable medium” which are analyzed the same as the “server” and do not provide a practical application or significantly more for the same reasons.
Claim 40 also includes the additional element of a “non-transitory computer readable medium” which is analyzed the same as the “server” and does not provide a practical application or significantly more for the same reasons.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 19-23 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (U.S. 2019/0034589) in view of Ginsburg et al. (U.S. 2023/0073347) and Linthicum et al. (U.S. 2010/0131293), referred to hereinafter as Chen, Ginsburg, and Linthicum, respectively.
REGARDING CLAIM 1
Chen teaches the method comprising:
maintaining a framework for categorizing time series patient data into one of a plurality of possible categories for managing patients with one or more chronic health conditions; [Para. 0076 teaches a framework. The various types of data collected by health systems were converted into time-sequenced (Para. 0058) resources (categories).]
receiving time series patient data spanning over a total time period, the time series patient data comprising a plurality of patient variables over time, and the total time period covering an entire patient history; [Para. 0063 teaches aggregating electronic health records (EHR). Para. 0055 teaches using all data recorded about patients, including variables. Para. 0119 teaches the data covers all historical time periods of the patient.]
dividing the total time period into a plurality of time intervals; [Fig. 4 teaches dividing the total time period into 4-hour increments.]
for each patient variable for each time interval of the plurality of time intervals, analyzing the time series patient data of the time interval using the framework to produce a category of the plurality of possible categories… [Para. 0069 teaches converting the data into a standardized format, a collection of resources (categories), and for each patient there is a “bundle” or set of such resources. These resources are then placed in time sequence order to create a timeline or chronological order of all the data in the EHR.]
generating graphic data for a GUI (Graphic User Interface) to display, for each patient variable for each time interval, a visual indication of the category for the time interval… and generating the GUI or transmitting the graphic data. [Para. 0148 teaches generating data from a health record and providing the data to an electronic device for rendering on an interface. Para. 0150 teaches a graphical display.]
Chen may not explicitly teach
…wherein analyzing the time series patient data comprises determining an average value of the patient variable over the time interval and comparing the average value to a threshold value or target range to produce the category for the patient variable in the time interval;
wherein the visual indications for a patient variable across the plurality of time intervals are displayed simultaneously to permit visualization of a progression of the patient variable across the entire patient history;
However, Ginsburg teaches the following:
…wherein analyzing the time series patient data comprises determining an average value of the patient variable over the time interval and comparing the average value to a threshold value or target range to produce the category for the patient variable in the time interval; [Para. 0222 teaches data can be highlighted by color to draw attention to or otherwise emphasize data exceeding a threshold. Para. 0369 teaches displaying an average value of a measured parameter for the time increment.]
wherein the visual indications for a patient variable across the plurality of time intervals are displayed simultaneously to permit visualization of a progression of the patient variable across the entire patient history; [Para. 0489 teaches the user can expand the entire history of the patient.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the method of Chen to determine an average value of a measured parameter over a time interval, compare the value to a threshold, and display the entire patient history as taught by Ginsburg, with the motivation of improving patient care (see Ginsburg at Para. 0240).
Chen in view of Ginsburg may not explicitly teach
…wherein the visual indication comprises a discretized representation generated from the patient variable for the time interval;
wherein the GUI comprises a timeline divided into a plurality of blocks corresponding to the plurality of time intervals and concurrently displays, for the plurality of patient variables, respective visual indications aligned with the plurality of blocks of the timeline;
wherein selection of a visual indication corresponding to a patient variable and a time interval causes display of underlying patient data associated with the patient variable and the time interval;
However, Linthicum teaches the following:
…wherein the visual indication comprises a discretized representation generated from the patient variable for the time interval; [Para. 0170 teaches displaying discrete data elements across the continuum of a patient record.]
wherein the GUI comprises a timeline divided into a plurality of blocks corresponding to the plurality of time intervals and concurrently displays, for the plurality of patient variables, respective visual indications aligned with the plurality of blocks of the timeline; [FIG. 7 teaches a timeline divided into a plurality of decades that displays data points via rectangles.]
wherein selection of a visual indication corresponding to a patient variable and a time interval causes display of underlying patient data associated with the patient variable and the time interval; [Para. 0010 teaches selecting a clinical data element in the representation provides additional information related to the clinical data element to the user.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the method of Chen in view of Ginsburg to display discrete data in an interactive timeline as taught by Linthicum, with the motivation of allowing the user to gain a greater understanding of comprehensive longitudinal data for a patient (see Linthicum at Para. 0170).
REGARDING CLAIM 2
Chen in view of Ginsburg and Linthicum teaches the method of claim 1.
Ginsburg further teaches
wherein the plurality of possible categories consists of two categories and wherein the discretized representation comprises a bimodal representation. [Para. 0222 teaches data can be highlighted by color to draw attention to or otherwise emphasize data exceeding a threshold. The two categories are “below threshold” (within target range) and “above threshold” (outside target range), i.e., bimodal.]
REGARDING CLAIM 3
Chen in view of Ginsburg and Linthicum teaches the method of claim 2.
Ginsburg further teaches
a first modality of the bimodal representation indicates that the average value is within the target range, and a second modality of the bimodal representation indicates that the average value is outside the target range. [Para. 0222 teaches data can be highlighted by color to draw attention to or otherwise emphasize data exceeding a threshold. The two categories are “below threshold” (within target range) and “above threshold” (outside target range), i.e., bimodal.]
REGARDING CLAIM 4
Chen in view of Ginsburg and Linthicum teaches the method of claim 3.
Ginsburg further teaches
wherein the bimodal representation for each patient variable comprises a first color for acceptable value of the patient variable and a second color for unacceptable value of the patient variable. [Para. 0222 teaches data can be highlighted by color to draw attention to or otherwise emphasize data exceeding a threshold. The first color is “no highlight” (acceptable) and the second color is “highlight” (unacceptable).]
REGARDING CLAIM 5
Chen in view of Ginsburg and Linthicum teaches the method of claim 4.
Ginsburg further teaches
wherein the first color is blue and a second color is red. [Para. 0222 teaches data can be highlighted by color and is thus interpreted to include blue and red (the color represents non-functional descriptive information in any event).]
REGARDING CLAIM 6
Chen in view of Ginsburg and Linthicum teaches the method of claim 4.
Ginsburg further teaches
providing a visual representation in a third color for any time interval for which there is no data for the patient variable. [Para. 0211 teaches columns and/or rows having no value present can be highlighted. Para. 0222 teaches data can be highlighted by color and is thus interpreted to include a third color (the color represents non-functional descriptive information in any event).]
REGARDING CLAIMS 16, 17, 33, AND 34
Chen in view of Ginsburg and Linthicum teaches the method(s) of claim 1/18.
Chen in view of Ginsburg and Linthicum may not explicitly disclose each time interval is at least six weeks or each time interval is eight weeks; however, this feature would have been prima facie obvious to one having skill in the art at the time of filing (time of the invention) based on the overlap of ranges obviousness rationale. MPEP 2144.05 states that "[a] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." Citing In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). Chen at Fig. 10 teaches a time interval of 4 years. As such, it would have been obvious to select a time interval of at least six weeks or a time interval of eight weeks, thus rendering the claimed invention obvious in view of the cited reference(s).
REGARDING CLAIMS 18-23
Claims 18-23 are analogous to Claims 1-6, thus Claims 18-23 are similarly analyzed and rejected in a manner consistent with the rejections of Claims 1-6.
REGARDING CLAIM 35
Chen in view of Ginsburg and Linthicum teaches the method of claim 18.
Chen further teaches
wherein the first client computing device is different from the second client computing device. [Para. 0058 teaches raw health records are transmitted (from a first client computing device) over computer networks. Para. 0148 teaches providing the data to an electronic/computing device (second client computing device).]
REGARDING CLAIM 36
Chen in view of Ginsburg and Linthicum teaches the method of claim 18.
Chen further teaches
wherein the first client computing device is same as the second client computing device. [Para. 0058 teaches raw health records are transmitted (from a first client computing device) over computer networks. Para. 0148 teaches providing the data to an electronic/computing device (second client computing device).]
The Examiner notes that a claim may be rendered obvious where the limiting function is that of making a set of prior-known elements contiguous, i.e., bringing them together. In this case, the limiting function is that of bringing together prior-known elements (a first client computing device and a second client computing device) together. As such, this claim would additionally have been prima facie obvious to one of ordinary skill in the art at the time of the invention. MPEP 2144.04.
Chen in view of Ginsburg and Linthicum fails to explicitly disclose that the computer used for input is the same as the electronic/computing device used for output. However, it would be obvious to one of ordinary skill in the art at the time of the invention to integrate the computing devices of Chen into a single structure, without undue experimentation or risk of unexpected results. See In re Larsen, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) “use of a one piece construction instead of the structure disclosed [in the prior art] would be merely a matter of obvious engineering choice.” See MPEP 2144.04.
REGARDING CLAIM 37
Chen in view of Ginsburg and Linthicum teaches the method of claim 18.
Chen further teaches
a non-transitory computer readable medium having recorded thereon statements and instructions that, when executed by a processor of a server, configure the server to implement the method of claim 18. [Para. 0008 teaches a computer memory.]
REGARDING CLAIM 38
Chen in view of Ginsburg and Linthicum teaches the method of claim 18.
Chen further teaches
a server, comprising: a network adapter configured to communicate with one or more client computing devices over a network; and variable categorization circuitry coupled to the network adapter and configured to implement the method of claim 18. [Para. 0058 teaches raw health records are transmitted (from a first client computing device) over computer networks. The Examiner notes that a person having skill in the art would understand transmitting data via computing devices necessarily includes variable categorization circuitry (a processor) coupled to a network adapter.]
REGARDING CLAIM 39
Chen in view of Ginsburg and Linthicum teaches the server of claim 38.
Chen further teaches
wherein: the variable categorization circuitry comprises a processor; and the server further comprises a non-transitory computer readable medium having recorded thereon statements and instructions that, when executed by the processor, configures the processor as the variable categorization circuitry. [Para. 0008 teaches a computer memory. Para. 0058 teaches raw health records are transmitted (from a first client computing device) over computer networks. The Examiner notes that a person having skill in the art would understand transmitting data via computing devices necessarily includes variable categorization circuitry (a processor).]
Claims 7 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Ginsburg, Linthicum, and Pangan et al. (U.S. 2022/0273651), referred to hereinafter as Pangan.
REGARDING CLAIM 7
Chen in view of Ginsburg and Linthicum teaches the method of claim 1.
Chen in view of Ginsburg and Linthicum may not explicitly teach
wherein the one or more chronic health conditions include IBD (Inflammatory Bowel Disease), and wherein the patient variables comprise CDIFF (Clostridium Difficile), CRP (C-Reactive Protein), FCP (Fecal Calprotectin), HB (Hemoglobin), WBC (White Blood Cell) count, and liver enzymes.
However, Pangan teaches the following:
wherein the one or more chronic health conditions include IBD (Inflammatory Bowel Disease), and wherein the patient variables comprise CDIFF (Clostridium Difficile), CRP (C-Reactive Protein), FCP (Fecal Calprotectin), HB (Hemoglobin), WBC (White Blood Cell) count, and liver enzymes. [Para. 0003 teaches IBD. Para. 1281 teaches Clostridium difficile. TABLE 44 teaches C-reactive protein, Fecal calprotectin, Hemoglobin, and white blood cell. Para. 1225 teaches liver enzymes.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the method of Chen in view of Ginsburg and Linthicum to include IBD, CDIFF (Clostridium Difficile), CRP (C-Reactive Protein), FCP (Fecal Calprotectin), HB (Hemoglobin), WBC (White Blood Cell) count, and liver enzymes as taught by Pangan, with the motivation of improving quality of life (see Pangan at Para. 0013).
REGARDING CLAIM 24
Claim 24 is analogous to Claim 7, thus Claim 24 is similarly analyzed and rejected in a manner consistent with the rejection of Claim 7.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Chen in view of Ginsburg, Linthicum, and Raduchel et al. (U.S. 2026/0039490), referred to hereinafter as Raduchel.
REGARDING CLAIM 40
Chen in view of Ginsburg and Linthicum teaches the server of claim 38.
Chen in view of Ginsburg and Linthicum may not explicitly teach
wherein the non-transitory computer readable medium stores the framework for categorizing time series patient data.
However, Raduchel teaches the following:
wherein the non-transitory computer readable medium stores the framework for categorizing time series patient data. [Para. 0148 teaches the memory stores frameworks.]
Therefore, it would have been prima facie obvious to one of ordinary skill in the art of computerized healthcare, before the effective filling date of the invention, to modify the method of Chen in view of Ginsburg and Linthicum to store the framework in the memory as taught by Raduchel, with the motivation of improving the quality of healthcare (see Raduchel at Para. 0125).
Response to Arguments
Drawings
Regarding the drawing objection(s), the Applicant has submitted replacement drawings which have alleviated several drawing issues; however, additional issues remain. As such, the objection is maintained.
Rejection under 35 U.S.C. § 112
Regarding the indefiniteness rejection of Claim 36, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
…there is nothing in claim 18 that requires that the first client computing device and the second client computing device are two separate devices.
Regarding (a), the Examiner respectfully disagrees. Labeling the computing devices as “first” and “second” distinguishes the computing devices.
Rejection under 35 U.S.C. § 101
Regarding the rejection of Claims 1-40, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Any arguments inadvertently not addressed are unpersuasive for at least the following reasons. Applicant argues:
These elements of the claims are computer-implemented operations for transforming time series patient data into a structured graphical representation and cannot reasonably be characterized as merely managing personal behavior or following rules.
Regarding (a), the Examiner respectfully disagrees. MPEP 2106. 04(a)(2)(II) states that a claimed invention is directed to certain methods of organizing human activity if the identified claim elements contain limitations that encompass fundamental economic principles or practices, commercial or legal interactions, or managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). The Examiner submits that, given the broadest reasonable interpretation in light of the Specification, the identified claim elements represent a series of rules or instructions for a person or persons, with the aid of a computer, to follow to collect, analyze, and display patient information. The Examiner notes that Applicant’s Background describes monitoring multiple patient variables over time (see Spec. Para. 0004) as a human task. Furthermore, the Examiner submits that healthcare itself inherently represents the organization of human activity. Applicant has not pointed to anything in the claims that fall outside of this characterization. Because the claim elements fall under a series of rules or instructions for a person or persons to follow to collect, analyze, and display patient information, the claimed invention is directed to an abstract idea.
…chronic disease management may require review of extensive information accumulated over time and that conventional displays may become visually overwhelming when attempting to present numerous variables simultaneously.
Regarding (b), the Examiner respectfully disagrees. MPEP 2106.04(d)(1) and MPEP 2106.05(a) indicates that a practical application may be present where the claimed invention provides a technical solution to a technical problem. See, e.g., DDR Holdings, LLC. v. Hotels.com, L.P., 773 F.3d 1245, 1259 (Fed. Cir. 2014) (finding that claiming a website that retained the “look and feel” of a host webpage provided a technological solution to the problem of retention of website visitors by utilizing a website descriptor that emulated the “look and feel” of the host webpage, where the problem arose out of the internet and was thus a technical problem). Here, the Applicant’s argued problem is not a technological problem caused by the computing device/GUI. The problem of extensive information accumulating over time causing conventional methods of display to produce visually overwhelming results was not a problem caused by the computer/GUI, it is a problem that existed and/or exists regardless of whether a computer/GUI is involved in the process. At best, Applicant’s identified problem is a healthcare information problem. Because no technological problem is present, the claims do not provide a practical application.
These claim elements define both the structure and operation of the graphical user interface.
Regarding (c), the Examiner respectfully disagrees. The claims describe a way of structuring information for display. Nothing in the claims describes a physical structure or operation that goes beyond using a generic GUI.
The question is not whether individual computer components are generic, but whether the claim elements, considered as an ordered combination, amount to significantly more than the judicial exception.
Regarding (d), the Examiner respectfully submits that whether the claim elements amount to significantly more than the judicial exception should be considered. As stated in the 101 analysis, the claim elements do not. Applicant has pointed to nothing in the “ordered combination” that would cause the claims to provide a practical application or significantly more by any measure in MPEP 2106.
The Office Action does not identify evidence demonstrating that this specific ordered combination was well-understood, routine, or conventional.
Regarding (e), the Examiner respectfully disagrees. MPEP 2106.05(d) states: “Another consideration when determining whether a claim recites significantly more than a judicial exception is whether the additional element(s) are well-understood, routine, conventional activities previously known to the industry (emphasis added).” Further, MPEP 2106.05(I) states: “As made clear by the courts, the novelty of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter (internal quotations omitted, emphasis original).” As such, it is only the additional elements identified by the Examiner to not be part of the abstract idea that are analyzed to determine whether they represent well-understood, routine, conventional activities in the field of the invention.
In that regard, the additional elements of the claims do not provide significantly more based on this inquiry.
Taking these in turn, whether the additional elements of the claim provide an improvement was analyzed/addressed in the 2A2 analysis. The technological environment to which the claims are confined (a general-purpose computer performing generic computer functions) is recited at a high level of generality and has been found by the courts to be insufficient to provide a practical application (see MPEP 2106.05(d)(II); Alice Corp.).
The additional elements of (1) receiving time series patient data and (2) transmitting the graphic data that were found to represent extra-solution activity were analyzed and determined to represent well-understood, routine, conventional activities in the field. As such, when viewed either individually or as an ordered combination, the additional elements do not provide significantly more to the abstract idea and the claims are not subject matter eligible.
Rejection under 35 U.S.C. § 102/103
Regarding the rejection of Claims 1-40, the Examiner has considered the Applicant’s arguments; however, the arguments are not persuasive. Applicant argues:
The FHIR resources remain representations of clinical data and do not constitute categories assigned to patient variables for discrete time intervals as required by the amended claims.
Regarding (a), the Examiner respectfully disagrees. Chen discloses that the clinical data are represented as features having an associated real value and a time component, therefore preserving the temporal relationship between a patient variable and its corresponding value.
Moreover, Chen discloses a “discretized value of a particular lab test” as a representation of clinical information. The fact that the representations are implemented using FHIR resources does not mean these representations are not discretized values or not associated with particular times in the patient’s chronological record.
A chronological arrangement of events is fundamentally different from dividing an entire patient history into a plurality of intervals and assigning a category to each patient variable for each interval.
Regarding (a), the Examiner respectfully disagrees. Chen organizes patient information according to temporal information associated with the clinical data and processes the patient information as time-sequenced features. The amended claim does not require that the underlying patient data itself originally comprise predefined intervals. Rather, the claim requires a representation of patient variables with respect to a plurality of time intervals. A person having ordinary skill in the art would have understood that temporally associated patient data may be organized into selected time intervals and that the data within each interval may be represented by a corresponding discretized value or category. This is a predictable application of Chen’s time-sequenced clinical data and discretized patient-variable representations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Harley et al. (U.S. 2022/0157436) which discloses a method and system for distributed management of transdiagnostic behavior therapy.
McNammee et al. (U.S. 2025/0342627) which discloses systems and methods for timeline visualization.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/CAMRYN B LEWIS/
Examiner, Art Unit 3683
/JASON S TIEDEMAN/Primary Examiner, Art Unit 3683
