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 .
Status of Claims
Claims 1-20, as originally filed on February 26, 2024, were previously pending and subject to a non-final office action filed on February 24, 2026 (the “February 24, 2026 Non-Final Office Action”), with claims 12-14, 16, 18, and 20 being withdrawn. Following the February 24, 2026 Non-Final Office Action, Applicant amended claims 1, 4, 11, 17, and 19, in an amendment filed on May 19, 2026 (the “May 19, 2026 Amendment”), see Applicant’s amended claims (pp. 2-9 of the May 19, 2026 Amendment). As such, claims 1-20, as recited in the May 19, 2026 Amendment, are currently pending and subject to the final office action below, with claims 12-14, 16, 18, and 20 being withdrawn.
Response to Applicant’s Remarks
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. § 101
Applicant’s arguments, see Applicant’s Remarks, pp. 14-18, Claim Rejections - 35 U.S.C. §101 Section, filed May 19, 2026, with respect to rejections of claims 1-11, 15, 17, and 19 under 35 U.S.C. § 101 have been fully considered, but they are not persuasive. Further, in light of the 2019 Revised Patent Subject Matter Eligibility Guidance (available at MPEP § 2106) (the “2019 Revised PEG”), the § 101 rejections of claims 1-11, 15, 17, and 19 are maintained.
Specifically, Applicant argues that the claims are directed to specific technological improvements in displaying patient information, rather than to merely abstract ideas implemented on a generic computer. See Applicant’s Remarks, at pp. 14 and 15. Examiner respectfully disagrees. When evaluating whether claims recite an improvement to the functioning of a computer or a technical field, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. MPEP § 2106.05(a). The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Id. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art.
For example, in the Core Wireless Licensing S.A.R.L. v. LG Electronics, Inc. case, the Federal Circuit determined that the asserted claims were directed to an improved user interface for computing devices, because the claims were directed to a particular manner of summarizing and presenting information in electronic devices. See MPEP § 2106.05(a)(I). The claims in the Core Wireless patent required “an application summary that can be reached directly from the menu,” specifying a particular manner by which the summary window must be accessed. Core Wireless, 800 F.3d 1356, 1362 (Fed. Cir. 2018). The claims further required the application summary window to list a limited set of data, “each of the data in the list being selectable to launch the respective application and enable the selected data to be seen within the respective application.” Id. This claim limitation restrains the type of data that can be displayed in the summary window. Id. at 1362-63. Finally, the claim recites that the summary window “is displayed while the one or more applications are in an un-launched state,” a requirement that the device applications exist in a particular state. Id. at 1363. The Federal Circuit held that these limitations disclosed a specific manner of displaying a limited set of information to the user, rather than using conventional user interface methods to display a generic index on a computer.
Conversely, in the present case, Appellant’s claims do not recite an improved graphical user interface. The limitation directed to “causing a display to display information indicating at least one of the plurality of pieces of vital data or an index associated with the plurality of pieces of vital data, and information indicating the content and the time of the treatment” is recited at a high level of generality and is well-understood, routine, and conventional (i.e., displaying certain information related to a plurality of vital data and the treatment duration). Further, the limitation directed to “causing a display to display information indicating at least one of the plurality of pieces of vital data or an index associated with the plurality of pieces of vital data, and information indicating the content and the time of the treatment” described in the claims 1, 17, and 19, is very generic and does not include any specific features for displaying information of the graphical user interface in a particular manner. Therefore, the claimed features fail to describe an improved graphical user interface for electronic devices, particularly those with small screens. For these reasons, this argument is not persuasive
Next, Applicant generally argues that the claims provide the specific implementation of a solution to a problem in the software arts, by improving a medical worker’s visual recognition of patient conditions. See Applicant’s Remarks, at p. 15. Examiner respectfully disagrees. This argument is not persuasive, because Applicant has not identified which limitation(s) in their claims provide this improvement and Applicant has not identified a problem that arises out of the technological field of computer networks. Therefore, the claimed features fail to describe an improved graphical user interface for electronic devices.
Therefore, the § 101 rejections of claims 1-11, 15, 17, and 19 are updated in this office action. Please see the amended rejections under the Claim Rejections – 35 U.S.C. § 101 Section below, for further clarification and complete analysis.
Response to Applicant’s Remarks Concerning Rejections under 35 U.S.C. §§ 102 & 103
Applicant’s arguments, see Applicant’s Remarks, pp. 10-14, Claim Rejections - 35 U.S.C. §§ 102 & 103 Section, filed May 19, 2026, with respect to rejections of claim 1-4, 7, 15, 17, and 19 under 35 U.S.C. § 102 and rejections of claims 5, 6, and 8-11 under 35 U.S.C. § 103, have been fully considered, but they are moot in light of Applicant’s amendments to independent claims 1, 17, and 19. Examiner notes that Applicant’s arguments for withdrawing the § 102 rejections are solely based on the new limitations added in the May 19, 2026 Amendment. Therefore, the combination of the references previously cited in the February 24, 2026 Non-Final Office Action, are not relied upon to teach the newly amended claim limitations in claims 1, 17, and 19. Consequently, any arguments pertaining to the newly amended claim limitations are moot. Please see the amended rejections under the Claim Rejections – 35 U.S.C. § 103 Section below, for further clarification and complete analysis.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 1-11, 15, 17, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. See MPEP § 2106 (hereinafter referred to as the “2019 Revised PEG”).
Step 1 of the Alice/Mayo Test
Following Step 1 of the 2019 Revised PEG, claims 1-11 are directed to a patient information processing method, which is within one of the four statutory categories (i.e., a process). See MPEP § 2106.03. Claim 15 is directed to a non-transitory computer readable storage medium, which is also within one of the four statutory categories (i.e., a manufacture). See Id. Claim 17 is directed to a patient information processing device, which is also within one of the four statutory categories (i.e., a machine or apparatus). See Id. Claim 19 is directed to a patient information processing system, which is also within one of the four statutory categories (i.e., a machine or apparatus). See Id.
Step 2A of the 2019 Revised PEG - Prong One
Following Prong One of Step 2A of the 2019 PEG, the claim limitations are to be analyzed to determine whether they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. See MPEP §2106.04. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: (1) Mathematical Concepts; (2) Certain Methods of Organizing Human Activity, and (3) Mental Processes. See MPEP § 2106.04(a).
Claims 1-11, 15, 17, and 19 are rejected under 35 U.S.C. § 101, because the claimed invention is directed to an abstract idea without significantly more. Representative independent claims 1, 15, 17, and 19 include limitations that recite an abstract idea. Note that independent claim 19 is directed to a patient information processing system, while claim 1 covers the matching patient information processing method, claim 15 covers the matching non-transitory computer readable storage medium, and claim 17 covers the matching patient information processing device. Specifically, independent claim 19 recites the following limitations:
A patient information processing system comprising:
a server; and
a display terminal communicably connected to the server,
wherein the patient information processing system is configured to:
obtain a plurality of pieces of vital data of a patient;
obtain information indicating a content and a time of a treatment performed on the patient; and
cause a display to display information indicating at least one of the plurality of pieces of vital data or an index associated with the plurality of pieces of vital data, and information indicating the content and the time of the treatment, wherein the time of the treatment is a value of a time duration.
However, the Examiner submits that the foregoing underlined limitations constitute a process that, under its broadest reasonable interpretation, falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. The Mental Processes category covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, or opinion) (i.e., a patient information processing method, comprising: obtaining a plurality of pieces of vital data of a patient; obtaining information indicating a content and a time of a treatment performed on the patient; and displaying information related to the obtained data/information, wherein the time of the treatment is a value of a time duration). See MPEP § 2106.04(a)(2)(III). That is, other than reciting some computer components and functions (the foregoing limitations in claims 19 which are not underlined), the context of claims 1, 15, 17, and 19 encompass concepts that are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper (including an observation, evaluation, judgment, and/or opinion) (i.e., a patient information processing method, comprising: obtaining a plurality of pieces of vital data of a patient; obtaining information indicating a content and a time of a treatment performed on the patient; and displaying information related to the obtained data/information, wherein the time of the treatment is a value of a time duration).
The aforementioned claim limitations described in claims 1, 15, 17, and 19 are analogous to claim limitations directed toward concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, because they merely recite limitations which encompass a person mentally and/or manually: (1) obtaining a plurality of pieces of vital data of a patient (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually obtain vital sign data such as by visually reviewing it); (2) obtaining information indicating a content and a time of a treatment performed on the patient (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could mentally and/or manually obtain information related to a content and time of a treatment performed on a patient such as by visually reviewing it); and (3) displaying information related to the obtained data/information, wherein the time of the treatment is a value of a time duration (i.e., a type of observation, evaluation, judgment, and/or opinion where a person could manually displaying the obtained information by writing it down on a piece of paper and holding it up for viewing by others).
Further, Applicant’s claims are similar to claims which have been held to recite an abstract mental process. For example, the Federal Circuit held the a claim directed to “collecting information, analyzing it, and displaying certain results of the collection and analysis”, where the data analysis steps are recited at a high level of generality amounted to steps that could practically be performed in the human mind. See MPEP § 2106.04(a)(2)(III)(A) (citing Electric Power Group g. Alstom, S.A.). Similarly, Applicant’s claims recite steps for collecting information (e.g., in this case, obtaining the vital data and the information indicating a content and time of a treatment performed on a patient); analyzing the data (not applicable for the independent claims in this case, because there are not any steps directed to analyzing the obtained information); and displaying certain results about the collection and analysis (i.e., in this case, displaying at least one of the plurality of pieces of vital data or an index associated with the plurality of pieces of vital data, and the information indicating the content and the time of the treatment, wherein the time of the treatment is a value of a time duration), at a high level of generality. Therefore, the aforementioned underlined claim limitations may reasonably be interpreted as mental/manual observations, evaluations, judgments, and/or opinions made by a person, such as a healthcare professional. If a claim limitation, under its broadest reasonable interpretation, covers concepts which are capable of being performed in the human mind or encompasses a human performing the step(s) mentally with the aid of a pen and paper, then it falls within the “Mental Processes” grouping of abstract ideas. See 2019 Revised PEG. Accordingly, claims 1, 15, 17, and 19 recite an abstract idea that falls within the Mental Processes category.
Furthermore, Examiner notes that dependent claims 4 and 6-11 further define the at least one abstract idea (and thus fail to make the abstract idea any less abstract) as set forth below. For example, claim 4 recites the additional mental step of obtaining information indicating a hospitalization time of the patient, and displaying the information indicating the hospitalization time of the patient; and claim 6 recites, in part, further details for narrowing down the time of vital data that is obtained in claim 1. Moreover, claims 7-11 merely recite further steps for calculating various scores related to the obtained information and changing thresholds/reference ranges for the vital data (i.e., these steps are deemed to be reasonably performed mentally, because they add additional steps that could be observations, evaluations, judgments, and/or opinions made by a person, such as a healthcare professional).
Step 2A of the 2019 Revised PEG – Prong Two
Regarding Prong Two of Step 2A of the 2019 Revised PEG, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. As noted in the 2019 Revised PEG, it must be determined whether any additional elements in the claims are indicative of integrating the abstract idea into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exception into a “practical application.” See MPEP §§ 2106.05 (f)-(h).
In the present case, for independent claim 19, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A patient information processing system (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) comprising:
a server (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)); and
a display terminal communicably connected to the server (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)),
wherein the patient information processing system is configured to (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)):
obtain a plurality of pieces of vital data of a patient;
obtain information indicating a content and a time of a treatment performed on the patient; and
cause a display (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) to display information indicating at least one of the plurality of pieces of vital data or an index associated with the plurality of pieces of vital data, and information indicating the content and the time of the treatment, wherein the time of the treatment is a value of a time duration.
However, the recitation of these generic computer components and functions in , such that it amounts to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
- The following is an example of court decisions that demonstrate merely applying instructions by reciting the computer structure as a tool to implement the claimed limitations (e.g., see MPEP § 2106.05(f)):
- Invoking computers or other machinery merely as a tool to perform an existing process, e.g. see, Affinity Labs v. DirecTV – similarly, the current invention invokes computers (i.e., the patient information processing device; non-transitory computer readable storage medium; patient information processing system; one or more processors; one or more memories; a server; and display terminal) to perform the existing processes of: obtaining a plurality of pieces of vital data of a patient; and obtaining information indicating a content and a time of a treatment performed on the patient.
- Using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data), e.g. see, TLI Communications LLC v. AV Auto, LLC – similarly, the current invention invokes the patient information processing device; non-transitory computer readable storage medium; patient information processing system; one or more processors; one or more memories; a server; and display terminal, in their ordinary capacity to obtain information (i.e., collect data) and display the information.
- Requiring the use of software to tailor information and provide it to the user on a generic computer, e.g., see Intellectual Ventures I LLC v. Capital One Bank (USA) – similarly, the current invention requires configuring the computing system (i.e., where the one or more non-transitory computer readable storage medium and one or more memories configured to store computer-readable instructions are deemed to be the equivalent of implementing generic software) to tailor information and provide it to the user on a generic computer (e.g., cause a display to display information indicating at least one of the plurality of pieces of vital data or an index associated with the plurality of pieces of vital data, and information indicating the content and the time of the treatment).
Thus, the additional elements in independent claims 1, 15, 17, and 19 are not indicative of integrating the judicial exception into a practical application. Examiner notes that dependent claims 2-6 recite the following additional elements identified in bold font below (with limitations deemed to be part of the above identified abstract idea identified in underlined font):
further comprising: a step of setting a visual mode of the information indicating the content and the time of the treatment, in accordance with the content and/or the time of the treatment (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 2);
further comprising: a step of setting a visual mode of the information indicating the plurality of pieces of vital data, in accordance with a comparison between a value of each of the plurality of pieces of vital data and a threshold set for each of the plurality of pieces of vital data (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 3);
further comprising: a step of obtaining information indicating a hospitalization time of the patient; and a step of causing the display to (the Examiner submits that this additional element amounts to adding insignificant extra-solution activity as noted below, see MPEP § 2106.05(g); and the Examiner further submits that such steps are not unconventional as they merely consist of receiving data over a network, as evidenced by the Intellectual Ventures v. Symantec case, as noted below in the Step 2B Analysis Section, see MPEP § 2106.05(d)) further display the information indicating the hospitalization time of the patient, the hospitalization time is a value indicating a number of hospitalization days (as described in claim 4);
further comprising: a step of setting a visual mode of the information indicating the hospitalization time of the patient, in accordance with a comparison between the hospitalization time and a threshold set for the hospitalization time (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 5); and
wherein the plurality of pieces of vital data includes first vital data related to a specific treatment, and the step of setting a visual mode of information indicating the first vital data includes: a step of changing a first threshold set for the first vital data, in a case where the specific treatment is performed on the patient; and a step of setting a visual mode of the information indicating the first vital data, in accordance with a comparison between a value of the first vital data and the changed first threshold (the Examiner submits that this additional element amounts to adding the words “apply it” (or an equivalent), or mere instructions to implement the abstract idea on a computer, see MPEP § 2106.05(f)) (as described in claim 6).
As such, the additional elements in claims 1-6, 15, 17, and 19 are not indicative of integrating the judicial exception into a practical application. Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, unlike the claims that have been held as a whole to be directed to an improvement or otherwise directed to something more than the abstract idea, claims 1-11, 15, 17, and 19: (1) are not directed to improvements to the functioning of a computer, or to any other technology or technical field similar to the Enfish, LLC v. Microsoft Corp. case (see MPEP § 2106.05(a)); (2) do not apply or use a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (see MPEP § 2106.04(d)(2)); (3) do not apply the judicial exception with, or by use of, a particular machine (see MPEP § 2106.05(b)); (4) do not effect a transformation or reduction of a particular article to a different state or thing (see MPEP § 2106.05(c)); nor do they (5) apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as whole is more than a drafting effort designed to monopolize the exception (see MPEP § 2106.05(e) and MPEP § 2106.04(d)(2)). For these reasons, claims 1-11, 15, 17, and 19 do not recite additional elements that integrate the judicial exception into a practical application.
Step 2B of the 2019 Revised PEG
Regarding Step 2B of the 2019 Revised PEG, claims 1-11, 15, 17, and 19 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 abstract idea into a practical application, the additional elements of claims 1-6, 15, 17, and 19 amount to no more than: (1) adding the words “apply it” (or is the equivalent of) with the judicial exception; mere instructions to implement an abstract idea on a computer; or merely uses a computer as a tool to perform an abstract idea; (2) adding insignificant extra-solution activity to the judicial exception; and (3) generally linking the use of a judicial exception to a particular technological environment or field of use. See MPEP §§ 2106.05(f)-(h). Further the additional elements, other than the abstract idea per se, when considered both individually and as an ordered combination, amount to no more than limitations consistent with what the courts recognize, or those having ordinary skill in the art would recognize, to be well-understood, routine, and conventional computer components. See MPEP § 2106.05 (d).
Specifically, the Examiner submits that the additional elements of claims 1-6, 15, 17, and 19, as recited, the non-transitory computer readable storage medium storing a program comprising instructions; computer; patient information processing device; patient information processing system; one or more processors; one or more memories configured to store a computer-readable instruction; server; display terminal communicably connected to the server; and the steps of: “cause a display to”; “a step of setting a visual mode of the information indicating the content and the time of the treatment, in accordance with the content and/or the time of the treatment”; “a step of setting a visual mode of the information indicating the plurality of pieces of vital data, in accordance with a comparison between a value of each of the plurality of pieces of vital data and a threshold set for each of the plurality of pieces of vital data”; “a step of causing the display to”; “a step of setting a visual mode of the information indicating the hospitalization time of the patient, in accordance with a comparison between the hospitalization time and a threshold set for the hospitalization time”; and “a step of setting a visual mode of the information indicating the first vital data, in accordance with a comparison between a value of the first vital data and the changed first threshold”, are well-understood, routine, and conventional functions. See MPEP § 2106.05(d)(II).
- In regard to the non-transitory computer readable storage medium storing a program comprising instructions; computer; patient information processing device; patient information processing system; one or more processors; one or more memories configured to store a computer-readable instruction; server; display terminal communicably connected to the server; and the steps of: “a step of setting a visual mode of the information indicating the content and the time of the treatment, in accordance with the content and/or the time of the treatment”; “a step of setting a visual mode of the information indicating the plurality of pieces of vital data, in accordance with a comparison between a value of each of the plurality of pieces of vital data and a threshold set for each of the plurality of pieces of vital data”; “a step of setting a visual mode of the information indicating the hospitalization time of the patient, in accordance with a comparison between the hospitalization time and a threshold set for the hospitalization time”; and “a step of setting a visual mode of the information indicating the first vital data, in accordance with a comparison between a value of the first vital data and the changed first threshold”, these additional elements or combination of elements in the claims, other than the abstract idea per se, amount to no more than well-understood, routine, and conventional activities previously known to the industry, because:
- Applicant’s disclosure supports this assertion. For example, Applicant discloses that: (1) the device may be a CO2 sensor or a pacemaker (see Applicant’s original specification, as filed on February 26, 2024, paragraph [0032]); (2) the server 2 can include an in-hospital information database (see Applicant’s original specification, as filed on February 26, 2024, paragraph [0017]); (3) the memory may include a read only memory (ROM) in which various programs are stored, and a random access memory (RAM) having a plurality of work areas in which various programs executed by the one or more processors are stored (see Applicant’s original specification, as filed on February 26, 2024, paragraph [0020]); (4) each processor may include at least one of, […] a central processing unit (CPU), micro processing unit (MPU), and a graphics processing unit (GPU). These passages in Applicant’s specification indicate that the system, device, and other computer components and functions are conventional in nature (i.e., well-understood, routine, and conventional computer devices and software), such as storing programs on a ROM/RAM and a generic central processing unit (CPU). Therefore, the Examiner submits that these devices and computer components represent well-understood, routine, and conventional computer devices which are known in the medical industry.
- The Examiner submits that these limitations amount to merely using a computer or other machinery as tools for performing their typical functionality in conjunction with performing the above-noted at least one abstract idea (see MPEP § 2106.05(f) and analysis of these limitations under Step 2A, Prong Two above).
Therefore, these limitations are also deemed to be well-understood, routine, and conventional under Step 2B for similar reasons since they are claimed in a generic manner.
- Regarding the steps and features directed to: “cause a display to” and “a step of causing the display to” - The following represents examples that courts have identified to be well-understood, routine, and conventional activities (e.g., see MPEP § 2106.05(d)):
- Receiving or transmitting data over a network, e.g., see Intellectual Ventures v. Symantec – similarly the limitations directed to: “cause a display to” and “a step of causing the display to”, are similarly deemed to be well-understood, routine, and conventional activity in the medical field, because they also represent mere collection and transmission of data over a network (i.e., causing a display to (i) display the vital sign data, the information indicating the content and the time of the treatment; and (ii) the information indicating the hospitalization time of the patient, are each the equivalent of receiving and transmitting data to a display device over a network).
Therefore, the additional elements described in claims 1-6, 15, 17, and 19 are deemed to be additional elements which do not amount to significantly more than the abstract idea identified above.
Thus, taken alone, the additional elements of claims 1-6, 15, 17, and 19 do not amount to significantly more than the above-identified judicial exception (the abstract idea). Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functionality of a computer or improves any other technology, and their collective functions merely provide conventional computer implementation. Therefore, whether taken individually or as an ordered combination, claims 1-6, 15, 17, and 19 are nonetheless rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
Additionally, dependent claims 7-11 (which individually depend on claim 1 due to their respective chains of dependency), do not include additional elements that are sufficient to amount to significantly more than the judicial exception. Examiner notes that dependent claims 7-11 do not include any additional elements beyond those identified as well-understood, routine, and conventional components as described above in the subject matter eligibility rejections of independent claims 1, 15, 17, and 19. Dependent claims 7-11 merely add limitations that further narrow the abstract idea described in independent claims 1, 15, 17, and 19. Therefore, claims 1-11, 15, 17, and 19 are rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 1-3, 7, 15, 17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over:
- Noro et al. (Pub. No. US 2019/0189282), in view of:
- George et al. (Pub. No. US 2022/0392621).
Regarding claims 1, 17, and 19,
- Noro et al. (Pub. No. US 2019/0189282) discloses:
- a patient information processing method executed by one or more processors (Noro, paragraphs [0035] and [0046]; Paragraph [0035] discloses a medical information processing method. Paragraph [0046] discloses that the apparatus and method are executed by processing circuitry, which is realized by using a processor.), the patient information processing method comprising (as described in claim 1):
- a patient information processing device (Noro, paragraph [0040]; Paragraph [0040] discloses a computer device, such as a workstation, a personal computer, a tablet terminal device, or the like.) comprising: one or more processors (Noro, paragraph [0046]; Paragraph [0046] discloses that the apparatus and method are executed by processing circuitry, which is realized by using a processor.); and one or more memories configured to store a computer-readable instruction, wherein , in a case where the computer-readable instruction is executed by the one or more processors (Noro, paragraph [0138]; Paragraph [0138] discloses that the programs may be provided as being recorded on a computer-readable storage medium such as a Compact Disk Read-Only Memory (CD-ROM), a Flexible Disk (FD), a Compact Disk Recordable (CD-R), a Digital Versatile Disk (DVD), or the like, in a file in such a format that is either installable or executable for the devices (i.e., examples of non-transitory computer readable storage media that store a program comprising instructions).), the patient information processing device is configured to (as described in claim 17):
- a patient information processing system (Noro, paragraph [0042]; Paragraph [0042] discloses a medical information processing apparatus 100 and the systems.) comprising: a server (Noro, paragraph [0136]; Paragraph [0136] discloses that the medical information processing apparatus includes an obtaining unit (i.e., a server).); and a display terminal communicably connected to the server (Noro, paragraphs [0034] and [0136]; Paragraph [0034] discloses that the medical information processing apparatus includes a display controlling unit (i.e., a display terminal). Paragraph [0136] discloses that the display controlling unit is in communication with the obtaining unit (i.e., the display terminal is connected to the server).), wherein the patient information processing system is configured to (as described in claim 19):
- a step of obtaining a plurality of pieces of vital data of a patient (as described in claims 1, 17, and 19) (Noro, paragraph [0049]; Paragraph [0049] discloses that vital sign data is diagnosis and treatment data related to vital signs and obtained from the radiation department system (i.e., obtaining a plurality of pieces of vital data of a patient).);
- a step of obtaining information indicating a content and a time of a treatment performed on the patient (as described in claims 1, 17, and 19) (Noro, paragraph [0054]; Paragraph [0055] discloses the display controlling function 151 receives, from the operator, an operation to designate a point in time or a time period within the display period displayed in the timeline display region 11 and further arranges detailed information indicating the specifics of the diagnosis and treatment data (i.e., obtaining information indicating a time of a treatment performed on the patient).) to be displayed in the diagnosis and treatment data display region 12, with respect to one or more events of diagnosis and treatment actions performed either at the designated point in time or during the designated time period (i.e., obtaining information indicating a time of the treatment performed on the patient).); and
- a step of causing a display to display information indicating at least one of the plurality of pieces of vital data or an index associated with the plurality of pieces of vital data (Noro, paragraph [0056]; Paragraph [0056] discloses that the display controlling function 151 refers to the vital sign data included in the integrated diagnosis and treatment DB and displays, in the diagnosis and treatment data display region 12, a graph 15 indicating changes in measured values related to vital signs taken either at the designated point in time or during the designated time period (i.e., displaying information indicating at least one of the plurality of pieces of vital data).), and to display information indicating the content and the time of the treatment (as described in claims 1, 17, and 19) (Noro, paragraphs [0054] and [0055]; Paragraph [0054] discloses that the display controlling function 151 displays icons corresponding to specifics of the events of the diagnosis and treatment actions performed on the subject during the display period (i.e., displaying information indicating the content of the treatment), in such a manner that at least one icon is arranged for each of the tally units obtained by dividing the display period into sections arranged in a time series (i.e., displaying information indicating the time of the treatment). Paragraph [0055] discloses that the displaying controlling unit displays the detailed information indicating the specifics of the obtained diagnosis and treatment data in the diagnosis and treatment data display region 12 (i.e., displaying information indicating the content and time of the treatment).).
…
- However, Noro does not explicitly teach, however, in analogous art of medical treatment systems and methods, George et al. (Pub. No. US 2022/0392621) teaches a method, device, and system, wherein:
- the time of the treatment is a value of a time duration (as described in claims 1, 17, and 19) (George, paragraph [0084]; Paragraph [0084] teaches the virtual assistant service may be configured to output, for display, at a display of one or more output devices 246, a graphical user interface (GUI) that includes graphical representations of real-time information associated with the medical treatment provided by the one or more medical devices as the one or more medical devices provides the medical treatment to patient 150, such as real-time values of parameters such as the current treatment duration (i.e., the time of the treatment is a value of a time duration). Paragraph [0084] teaches that this feature is beneficial for displaying graphical representations of real-time information associated with the medical treatment.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical systems and methods at the time of the effective filing date of the claimed invention to modify the medical information processing method taught by Noro, to incorporate a step and feature directed to including the treatment duration on the display, as taught by George, in order to display graphical representations of real-time information associated with the medical treatment. See George, paragraph [0084]; see also MPEP § 2143 G.
Regarding claim 2,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 1 (which claim 2 depends on), as described above.
- Noro discloses a method, further comprising:
- a step of setting a visual mode of the information indicating the content and the time of the treatment, in accordance with the content and/or the time of the treatment (Noro, paragraph [0058]; Paragraph [0058] discloses that the display controlling function 151is configured to display icons expressing the specifics of the events (i.e., a setting of a visual mode) and being arranged in the corresponding sections of the panel 16, on the basis of the diagnosis and treatment data related to the events of the diagnosis and treatment actions performed either at the designated point in time or during the designated time period (i.e., the visual mode shows information indicating the content and time of the treatment). For example, paragraph [0058] further discloses that the display controlling function 151 displays the events with respect to either the entire time period containing the diagnosis and treatment data or a time period from the current date/time up to two weeks earlier (i.e., examples of different settings for the visual mode).).
The motivations and rationales for modifying the medical information processing method taught by Noro, in view of George, described in the analysis of the obviousness rejection of claim 1 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claim 3,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 1 (which claim 3 depends on), as described above.
- Noro discloses a method, further comprising:
- step of setting a visual mode of the information indicating the plurality of pieces of vital data, in accordance with a comparison between a value of each of the plurality of pieces of vital data and a threshold set for each of the plurality of pieces of vital data (Noro, paragraph [0106] and FIG. 23; Paragraph [0106] discloses that as illustrated in FIG. 23, by receiving an operation performed by the operator on any of radio buttons 18 corresponding to the colors and being displayed together with the panel 16, the calculating function 155 may display a color only in such sections to which the selected color is assigned. Alternatively, by receiving an operation performed by the operator on a slide bar 19 displayed together with the panel 16, the calculating function 155 may display a color only in such sections of which the tallied value is equal to or larger than a threshold value (i.e., a setting of the visual mode that indicates the plurality of vital data in comparison with a threshold value set for each of the plurality of vital data). With any of these arrangements, it is possible to display the information while placing an emphasis on a specific piece of information.).
The motivations and rationales for modifying the medical information processing method taught by Noro, in view of George, described in the analysis of the obviousness rejection of claim 1 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claim 7,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 1 (which claim 7 depends on), as described above.
- Noro discloses a method, further comprising:
- a step of calculating a vital score indicating a condition of the patient, at least based on the plurality of pieces of vital data (Noro, paragraphs [0071] and [0072]; Paragraph [0071] discloses that the tallying function 154 tallies, as the index value, abnormality values (i.e., calculating a vital score) each indicating an abnormality in either the diagnosis and treatment actions or the state of the subject (i.e., the vital score indicates a condition of the patient). In this situation, the abnormality values are numerical values each of which indicates a certain abnormality related to either the diagnosis and treatment actions or the state of the subject (i.e., the abnormality values are interpreted to be the equivalent of the vital score, because they are numerical values that indicate the state of the subject patient) and which are defined in correspondence with the types of events of the diagnosis and treatment actions. For example, with respect to the vital signs, the tallying function 154 tallies the number of times when a measured value fell outside a reference range as an abnormality value (i.e., the vital score is at least based on the plurality of pieces of vital data).), wherein the index associated with the plurality of pieces of vital data is the vital score (Noro, paragraph [0071]; Paragraph [0071] discloses that the tallies are explained with respect to vital signs (i.e., the index values from the tallies are associated with the plurality of pieces of vital data where the vital score is derived from).).
The motivations and rationales for modifying the medical information processing method taught by Noro, in view of George, described in the analysis of the obviousness rejection of claim 1 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Regarding claim 15,
- Noro discloses:
- a non-transitory computer readable storage medium storing a program comprising instructions which, when executed by a computer (Noro, paragraph [0138]; Paragraph [0138] discloses that the programs may be provided as being recorded on a computer-readable storage medium such as a Compact Disk Read-Only Memory (CD-ROM), a Flexible Disk (FD), a Compact Disk Recordable (CD-R), a Digital Versatile Disk (DVD), or the like, in a file in such a format that is either installable or executable for the devices (i.e., examples of non-transitory computer readable storage media that store a program comprising instructions).), cause the computer to execute the patient information processing method according to claim 1 (The mapping of the paragraphs in Noro relied upon for disclosing the limitations of claim 1 are also relied upon for this claim and are incorporated herein by reference.).
The motivations and rationales for modifying the medical information processing method taught by Noro, in view of George, described in the analysis of the obviousness rejection of claim 1 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Noro et al. (Pub. No. US 2019/0189282), as modified in view of George et al. (Pub. No. US 2022/0392621), as applied to claim 1 above, and further in view of:
- Okada (Pub. No. US 2022/0344048).
Regarding claim 4,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 1 (which claim 4 depends on), as described above.
- Noro discloses a method, further comprising:
- a step of obtaining information indicating a hospitalization time of the patient; and a step of causing the display to further display the information indicating the hospitalization time of the patient (Noro, paragraphs [0120] and [0121] and FIG. 27; Paragraph [0120] and [0121] discloses that as FIG. 27 illustrates, critical event data is generated by the operator. Paragraph [0121] further discloses that as the specifics of the events, pieces of information indicating specifics of the critical events (e.g., hospitalization (i.e., obtaining information indicating a hospitalization of the patient), a sudden change in the subject's condition, stabilization of the subject's condition) are set. FIG. 27 illustrates that the display may show a date and time for the specific event of a hospitalization, along with the patient’s ID (i.e., obtaining and displaying the information indicating a hospitalization time of the patient).).
…
- The combination of: Noro, as modified in view of George, does not explicitly teach, however, in analogous art of medical systems and methods, Okada (Pub. No. US 2022/0344048) teaches a method, wherein:
- the hospitalization time is a value indicating a number of hospitalization days (Okada, paragraph [0032]; Paragraph [0032] teaches that the number of days required for hospitalization may be displayed on the display device 15 (i.e., the hospitalization time is a value indicating a number of hospitalization days) such as a display unit. Paragraph [0032] teaches that this feature is beneficial for displaying the severity of the patient’s condition., thus an emergency physician can instantly know the comprehensive severity of the patient.).
Therefore, it would have been obvious to one of ordinary skill in the art of medical systems and methods at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of George, to incorporate a step and feature directed to including the number of hospitalization days on the display, as taught by Okada, in order to display the severity of the patient’s condition., thus an emergency physician can instantly know the comprehensive severity of the patient. See Okada, paragraph [0032]; see also MPEP § 2143 G.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Noro et al. (Pub. No. US 2019/0189282), as modified in view of George et al. (Pub. No. US 2022/0392621), as applied to claim 4 above, and further in view of:
- Ruano et al. (Pub. No. US 2011/0098186).
Regarding claim 5,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 4 (which claim 5 depends on), as described above.
- The combination of: Noro, as modified in view of George, does not explicitly teach, however, in analogous art of systems and methods for monitoring treatments of a patient, Ruano et al. (Pub. No. US 2011/0098186) teaches a method, wherein:
- a step of setting a visual mode of the information indicating the hospitalization time of the patient, in accordance with a comparison between the hospitalization time and a threshold set for the hospitalization time (Ruano, paragraphs [0056] and [0080], and Table 5; Paragraph [0080] teaches that Table 5 shows comparisons of lengths of patient hospitalization with Drug Metabolism Reserve Physiotype indices (i.e., setting a visual mode of the information indicating a hospitalization time of the patient). Paragraph [0080] also teaches that individuals with an metabolic alteration index of 1.5 or less had an average length of hospitalization of 6.1 days, compared to 7.0 days for patients with an index greater than 1.5 (p=0.14). (i.e., the information indicates a comparison between the hospitalization time and a threshold set for the hospitalization time). Paragraph [0056] teaches that this feature is beneficial for customizing a drug regimen for the patient to reduce a length of hospitalization or reduce a risk of re-hospitalization.).
Therefore, it would have been obvious to one of ordinary skill in the art of methods for monitoring treatments of a patient at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of George, to incorporate a step and feature directed to setting a visual mode of the information to indicate a comparison between the hospitalization of the patient and a threshold set for the hospitalization time, as taught by Ruano, in order to customize a drug regimen for the patient to reduce a length of hospitalization or reduce a risk of re-hospitalization. See Ruano, paragraph [0056]; see also MPEP § 2143 G.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Noro et al. (Pub. No. US 2019/0189282), as modified in view of George et al. (Pub. No. US 2022/0392621), as applied to claim 3 above, and further in view of:
- Mazar et al. (Pub. No. US 2015/03025393).
Regarding claim 6,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 3 (which claim 6 depends on), as described above.
- Noro further discloses a method, wherein:
- the plurality of pieces of vital data includes first vital data related to a specific treatment (Noro, paragraph [0072]; Paragraph [0072] discloses that the tallying function 154 tallies the number of times when a measured value fell outside the reference range, by referring to the vital sign data included in the integrated diagnosis and treatment DB (i.e., the vital data includes first vital data related to a specific treatment) and the reference range table stored in the storage 120.).
…
…
- Noro does not explicitly teach, however, in analogous art of systems and methods for monitoring patient data, Mazar et al. (Pub. No. US 2015/0302539) teaches a method, wherein the step of setting a visual mode of information indicating the firs vital data includes:
- a step of changing a first threshold set for the first vital data, in a case
where the specific treatment is performed on the patient (Mazar, paragraphs [0045]; Paragraph [0045] teaches the caregiver can use the bedside monitor 108 to log a therapy activity for the patient and make notes about physical therapy progress for the patient (i.e., a case where a specific treatment is performed on the patient). Paragraph [0045] teaches the caregiver 110 can use the bedside monitor 108 to adjust ranges for what is considered a “normal” or “safe” range for one or more vital signs for the patient 104 (i.e., changing a first threshold set for the first vital data, in a case where the specific treatment is performed).); and
- a step of setting a visual mode of the information indicating the first vital data, in accordance with a comparison between a value of the first vital data and the changed first threshold (Mazar, paragraph [0141]; Paragraph [0141] teaches the user interface 385 can also include indications of recorded vital sign information or other information that is outside of a specified normal range for the patient (i.e., a visual mode of the information indicating the first vital data with a comparison between a value of the first vital data and the changed vital threshold). This can include vital signs that deviate enough from indicate normal ranges to rise to the level of an alarm state as well as slight deviations from a normal level (i.e., a visual mode with a comparison between a value of the first vital data and the changed vital threshold). Paragraph [0141] teaches that this feature is beneficial for helping a caregiver to quickly identify problems for the patient to better determine a course of care for the patient.).
Therefore, it would have been obvious to one of ordinary skill in the art of methods for monitoring patient data at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of George, to incorporate steps and features directed to (i) changing a first threshold set for the first vital data, in a case where the specific treatment is performed, and (ii) setting a visual mode of the information indicating the first vital data with a comparison between a value of the first vital data and the changed vital threshold, as taught by Mazar, in order to help a caregiver to quickly identify problems for the patient to better determine a course of care for the patient. See Mazar, paragraph [0141]; see also MPEP § 2143 G.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Noro et al. (Pub. No. US 2019/0189282), as modified in view of George et al. (Pub. No. US 2022/0392621), as applied to claim 7 above, and further in view of:
- Maeta (Pub. No. US 2023/0119139); and
- Mazar et al. (Pub. No. US 2015/03025393).
Regarding claim 8,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 7 (which claim 8 depends on), as described above.
- Noro further discloses a method, wherein the step of calculating a vital score includes:
- a step of calculating a sub score of each of the plurality of pieces of vital data, in accordance with a comparison between each of the pieces of plurality of vital data and a reference range set for each of the plurality of pieces of vital data (Noro, paragraph [0072]; Paragraph [0072] discloses that the tallying function 154 tallies the number of times when a measured value fell outside the reference range, by referring to the vital sign data included in the integrated diagnosis and treatment DB (i.e., the vital data includes first vital data related to a specific treatment) and the reference range table stored in the storage 120.).
…
…
…
- Noro does not explicitly teach, however, in analogous art of systems and methods for monitoring patient data, Maeta (Pub. No. US 2023/0119139) teaches a method, wherein the step of calculating a vital score includes:
- a step of calculating the vital score, based on each calculated sub score,
the plurality of pieces of vital data include first vital data related to a specific treatment (Maeta, paragraphs [0023] and [0270]; Paragraph [0023] teaches the EWS [early warning score] is a technique for calculating a score according to a measurement result or an evaluation result of vital signs (i.e., calculating sub scores for the plurality of pieces of vital data included in the first vital data), based on the measurement of the subject's six major signs: respiratory rate (rpm), oxygen saturation (SpO2) (%), body temperature (° C.), blood pressure (mmHg), heart rate (bpm), and consciousness level (AVPU response: A: alert (normal), V: voice (responsive to voice), P: pain (responsive to pain), U: unresponsive), and determining the degree of disease by the total score of the score (refer, e.g., non-patent literature 1) (i.e., the step of calculating the vital score is based on each calculated sub score). Paragraph [0270] teaches that this feature is beneficial for determining whether vital sign data is abnormal with respect to the total score of score valuation information of all types of vital signs.).
Therefore, it would have been obvious to one of ordinary skill in the art of methods for monitoring patient data at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of George, to incorporate a step and feature directed to calculating a vital score based on calculated sub scores for a plurality of pieces of vital data related to a specific treatment, as taught by Maeta, in order to determine whether vital sign data is abnormal with respect to the total score of score valuation information of all types of vital signs. See Maeta, paragraph [0270]; see also MPEP § 2143 G.
- The combination of: Noro, as modified in view of: George and Maeta, does not explicitly teach, however, in analogous art of systems and methods for monitoring patient data, monitoring patient data, Mazar et al. (Pub. No. US 2015/0302539) teaches a method, wherein the step of calculating a first sub score of the first vital data includes:
- the step of calculating a first sub score of the first vital data includes:
- a step of changing a first reference range set for the first vital data, in a case where the specific treatment is performed on the patient (Mazar, paragraphs [0045]; Paragraph [0045] teaches the caregiver can use the bedside monitor 108 to log a therapy activity for the patient and make notes about physical therapy progress for the patient (i.e., a case where a specific treatment is performed on the patient). Paragraph [0045] teaches the caregiver 110 can use the bedside monitor 108 to adjust ranges for what is considered a “normal” or “safe” range for one or more vital signs for the patient 104 (i.e., changing a first reference range set for the first vital data, in a case where the specific treatment is performed on the patient).); and
- a step of calculating the first sub score, in accordance with a comparison between a value of the first vital data and the changed first reference range (Mazar, paragraph [0141]; Paragraph [0141] teaches the user interface 385 can also include indications of recorded vital sign information or other information that is outside of a specified normal range for the patient (i.e., a comparison between a value of the first vital data and the changed vital threshold). This can include vital signs that deviate enough from indicate normal ranges to rise to the level of an alarm state as well as slight deviations from a normal level (i.e., a comparison between a value of the first vital data and the changed vital threshold). Paragraph [0141] teaches that these features are beneficial for helping a caregiver to quickly identify problems for the patient to better determine a course of care for the patient.).
Therefore, it would have been obvious to one of ordinary skill in the art of methods for monitoring patient data at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of: George and Maeta, to incorporate steps and features directed to (i) changing a first reference range set for the first vital data, in a case where the specific treatment is performed, and (ii) calculating a first sub score in accordance with a comparison between a value of the first vital data and the changed first reference range, as taught by Mazar, in order to help a caregiver to quickly identify problems for the patient to better determine a course of care for the patient. See Mazar, paragraph [0141]; see also MPEP § 2143 G.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Noro et al. (Pub. No. US 2019/0189282), as modified in view of George et al. (Pub. No. US 2022/0392621), as applied to claim 7 above, and further in view of:
- Fujisawa et al. (Pub. No. US 2023/0076824); and
- Maeta (Pub. No. US 2023/01191393).
Regarding claim 9,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 7 (which claim 9 depends on), as described above.
- Noro further discloses a method, wherein the step of calculating a vital score includes:
- a step of calculating a sub score of each of the plurality of pieces of vital data, based on a comparison between each of the plurality of pieces of vital data and a reference range set for each of the plurality of pieces of vital data (Noro, paragraph [0072]; Paragraph [0072] discloses that the tallying function 154 tallies the number of times when a measured value fell outside the reference range, by referring to the vital sign data included in the integrated diagnosis and treatment DB and the reference range table stored in the storage 120 (i.e., the sub score for the plurality of pieces of vital data is based on a comparison between each of the plurality of pieces of vital data and a reference range set for each of the plurality of pieces of vital data).).
…
…
- Noro does not explicitly teach, however, in analogous art of systems and methods for monitoring and processing patient data, Fujisawa et al. (Pub. No. US 2023/0076824) teaches a method, wherein the step of calculating a vital score includes:
- a step of calculating a sub score related to a treatment performed on the patient, based on information related to the treatment (Fujisawa, paragraphs [0022] and [0074]; Paragraph [0074] teaches that the disease QI is an index value for measuring a treatment effect of how much a disease of each patient in the population has been treated when the patient in the population is treated according to a certain treatment method (i.e., calculating a sub score related to a treatment performed on the patient). For example, when the disease of the patient is cancer, the disease QI may be a 5-year survival rate, the number of days of postoperative hospital stay, a recurrence rate, cancer survival rate, a percentage of breast conserving surgery (i.e., the sub score is based on information related to the treatment), and the like. Paragraph [0022] teaches that this feature is beneficial for selecting a treatment method that is suitable for an intention of a patient or his or her family.).
Therefore, it would have been obvious to one of ordinary skill in the art of methods for monitoring and processing patient data at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of George, to incorporate a step and feature directed to calculating a sub score related to a treatment performed on the patient that is based on information related to the treatment, as taught by Fujisawa, in order to select a treatment method that is suitable for an intention of a patient or his or her family. See Fujisawa, paragraph [0022]; see also MPEP § 2143 G.
- Further, the combination of Noro, as modified in view of: George and Fujisawa, does not explicitly teach, however, in analogous art of systems and methods for monitoring patient data, Maeta (Pub. No. US 2023/0119139) teaches a method, wherein the step of calculating a vital score includes:
- a step of calculating the vital score, at least based on the sub score of each
of the plurality of pieces of vital data and the sub score related to the treatment (Maeta, paragraphs [0023] and [0270]; Paragraph [0023] teaches the EWS [early warning score] is a technique for calculating a score according to a measurement result or an evaluation result of vital signs (i.e., calculating sub scores for each of the plurality of pieces of vital data), based on the measurement of the subject's six major signs: respiratory rate (rpm), oxygen saturation (SpO2) (%), body temperature (° C.), blood pressure (mmHg), heart rate (bpm), and consciousness level (AVPU response: A: alert (normal), V: voice (responsive to voice), P: pain (responsive to pain), U: unresponsive), and determining the degree of disease by the total score of the score (refer, e.g., non-patent literature 1) (i.e., the step of calculating the vital score is based on each calculated sub score). Paragraph [0104] teaches that the predetermined scoring condition includes determining a state in which a subject takes drugs that act on blood pressure or pulse or has been given a prescription or treatment that acts on changes in other vital signs (i.e., the step of calculating the vital score is based on calculating a sub score related to the treatment of the patient). Paragraph [0270] teaches that this feature is beneficial for determining whether vital sign data is abnormal with respect to the total score of score valuation information of all types of vital signs.).
Therefore, it would have been obvious to one of ordinary skill in the art of methods for monitoring patient data at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of: George and Fujisawa, to incorporate a step and feature directed to calculating a vital score based on calculated sub scores for a plurality of pieces of vital data and a sub score related to the specific treatment of the patient, as taught by Maeta, in order to determine whether vital sign data is abnormal with respect to the total score of score valuation information of all types of vital signs. See Maeta, paragraph [0270]; see also MPEP § 2143 G.
Regarding claim 10,
- The combination of: Noro, as modified in view of: George; Fujisawa; and Maeta, teaches the limitations of claim 9 (which claim 10 depends on), as described above.
- Fujisawa further teaches a method, wherein the step of calculating a vital score includes:
- a step of calculating a sub score related to the hospitalization time, based on information indicating a hospitalization time of the patient (Fujisawa, paragraph [0073]; Paragraph [0073] teaches that the hospital PI is an index value (i.e., the step of calculating a vital score includes calculating a sub score) regarding a temporal or economic cost spent by each patient in the population, such as the number of hospitalization days (i.e., the sub score is related to information including a hospitalization time of the patient) or a treatment cost.); and
- a step of calculating the vital score, based on a sub score of each of the plurality of pieces of vital data (Fujisawa, paragraph [0067]; Paragraph [0067] teaches that FIG. 7 is a diagram illustrating an example attribute distribution [to a quantitative value of the target patient (i.e., the vital score)]. Paragraph [0067] further teaches that in area (b), for example, the quantitative value of a vital sign at a current point in time is plotted (i.e., the step of calculating the vital score is based on a sub score of each of the plurality of pieces of vital data).), a sub score related to the treatment (Fujisawa, paragraph [0074]; Paragraph [0074] teaches that the disease QI is an index value (i.e., the step of calculating a vital score includes calculating a sub score) for measuring a treatment effect of how much a disease of each patient in the population has been treated when the patient in the population is treated according to a certain treatment method (i.e., the sub score is related to the treatment of the patient).), and a sub score related to the hospitalization time (Fujisawa, paragraph [0073]; Paragraph [0073] teaches that the hospital PI is an index value (i.e., the step of calculating a vital score includes calculating a sub score) regarding a temporal or economic cost spent by each patient in the population, such as the number of hospitalization days (i.e., the sub score is related to information including a hospitalization time of the patient) or a treatment cost.).
The motivations and rationales for modifying the medical information processing method taught by Noro, in view of: George; Fujisawa; and Maeta, described in the analysis of the obviousness rejection of claim 9 similarly apply to this obviousness rejection, and are incorporated herein by reference.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over:
- The combination of: Noro et al. (Pub. No. US 2019/0189282), as modified in view of George et al. (Pub. No. US 2022/0392621), as applied to claim 1 above, and further in view of:
- Gross et al. (Pub. No. US 2016/0117813); and
- Bockelman et al. (Pub. No. US 2014/0330572).
Regarding claim 11,
- The combination of: Noro, as modified in view of George, teaches the limitations of claim 1 (which claim 11 depends on), as described above.
- The combination of: Noro, as modified in view of George, does not explicitly teach, however, in analogous art of systems and methods for monitoring vital signs of a patient, Gross et al. (Pub. No. US 2016/0117813) teaches a method, wherein:
- the information indicating the content and the time of the treatment performed on the patient includes information indicating a type and a connection time of a medical device connected to the patient (Gross, paragraphs [0154], [0155], and [0208]; Paragraph [0154] teaches that the bridge is able to report and determine the following: group and sort devices by manufacture, device model, revisions information and display devices serial numbers, unique device ID, asset number, revisions, etc. (i.e., information indicating a type of medical device connected to the patient). Paragraph [0155] also teaches that the bridge is able to report and determine the last time a specific unit connected to the EMR capture system (i.e., information indicating the connection time of a medical device connected to the patient). Paragraph [0208] teaches that this feature is beneficial for managing and storing multiple record readings for multiple patients and presenting the information to an operator in an understandable and consistent manner.).
Therefore, it would have been obvious to one of ordinary skill in the art of methods for monitoring vital signs of a patient at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of George, to incorporate a step and feature directed to indicting a type and a connection time of a medical device connected to the patient, as taught by Gross, in order to (i) manage and store multiple record readings for multiple patients and (ii) present the information to an operator in an understandable and consistent manner. See Gross, paragraph [0208]; see also MPEP § 2143 G.
- Further, the combination of: Noro, as modified in view of: George and Gross, does not explicitly teach, however, in analogous art of systems and methods for monitoring patient treatments, Bockelman et al. (Pub. No. US 2014/0330572) teaches a method, wherein:
- the time of the treatment is a value of a number of connection days of the medical device (Bockelman, paragraphs [0023] and [0043]; Paragraph [0043] teaches that the treatment length 310 is the time duration during which test product 305 is tested (e.g., time during which a subject receives the medicinal drug or uses the medical device), which can be specified in days, weeks, or months (i.e., the time of the treatment is a value of a number of connection days of the medical device). Paragraph [0023] teaches that this feature is beneficial for collecting statistically meaningful result data.).
Therefore, it would have been obvious to one of ordinary skill in the art of systems and methods for monitoring patient treatments at the time of the effective filing date of the claimed invention to further modify the medical information processing method taught by Noro, as modified in view of: George and Gross, to incorporate a step and feature directed to indicting a time duration that the subject uses the medical device specified in days, as taught by Bockelman, in order to collect statistically meaningful result data. See Bockelman, paragraph [0023]; see also MPEP § 2143 G.
Conclusion
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).
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/N.A.A./Examiner, Art Unit 3686
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