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 .
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Following is an analysis of subject matter eligibility according to MPEP 2106:
Step 1:
Independent claims 1 and 11 recite at least one step or act of accessing data, and thus the claim is directed to a process, which is one of the statutory categories of invention.
Step 2A Prong 1:
Claim 1 recites the following limitations:
receiving (120), from a patient database, demographic information about the patient;
receiving (130), at the sepsis analysis system, observation data from a patient monitoring device;
receiving (140) one or more patient responses, wherein the one or more patient responses are provided by the patient in response to one or more queries or commands posed to the patient by the sepsis analysis system, and wherein the one or more queries or commands are configured to elicit, in the one or more patient responses, information relevant to the patient's sepsis status;
analyzing (150), by a trained patient sepsis status model of the sepsis analysis system, the received demographic information, the received observation data, and the one or more patient responses to predict a sepsis status for the patient; and
This limitation, under the broadest reasonable interpretation, cover concepts that can be practically performed in the human mind (or by using pen and paper). With generating a sepsis status for a patient based on data received from a database, received observation data from an analysis system, and one or more patient responses, a human could reasonably collect or receive data and information to analyze a sepsis status. This concept aligns with MPEP 2106.04(a)(2). Mental process where claims reciting: “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 such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)”, were determined to comprise “a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.” Thus, the present claims recite limitations which fall within the 'mental processes’ grouping of abstract ideas.
Claim 11 recites the following limitations:
a trained patient sepsis status model (265) configured to generate a sepsis status for the patient based on received demographic information, received observation data, and one or more patient responses;
and a user interface (240) configured to provide the predicted sepsis status for the patient.
This limitation, under the broadest reasonable interpretation, cover concepts that can be practically performed in the human mind (or by using pen and paper). With generating a sepsis status for a patient based on received demographic information, received observation data, and one or more patient responses, a human could reasonably collect or receive data and information to generate a sepsis status. This concept aligns with MPEP 2106.04(a)(2). Mental process where claims reciting: “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 such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)”, were determined to comprise “a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.” Thus, the present claims recite limitations which fall within the 'mental processes’ grouping of abstract ideas.
Furthermore, under the broadest reasonable interpretation, a user interface configured to provide information cover concepts that can be practically performed in the human mind (or by using pen and paper).
With providing “the predicted sepsis status for the patient”, a human could reasonably convey information for the patient. This concept aligns with MPEP 2106.04(a)(2). Mental process where claims reciting: “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 such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016)”, were determined to comprise “a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions.” Thus, the present claims recite limitations which fall within the 'mental processes’ grouping of abstract ideas.
Step 2A Prong 2:
Claim 1 recites the following additional elements:
receiving (130), at the sepsis analysis system, observation data from a patient monitoring device;
reporting (170), via a user interface of the sepsis analysis system, the predicted sepsis status for the patient.
The limitations and associated elements are mere data gathering and output recited at a high level of generality and thus amount to insignificant extra-solution activity. See MPEP 2106.05(g). In addition, all users of the recited judicial exceptions require such data gathering and output, an as such, these limitations do not impose any meaningful limits of the claim. These limitations amount to necessary data gathering and outputting. See MPEP 2106.05. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application. Accordingly, even in combination, the additional element noted above, do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Claim 11 recite the following additional element:
a processor (220) configured to: (i) receive, from a patient database, demographic information about the patient; (ii) receive, at the sepsis analysis system, observation data from a patient monitoring device; (iii) receive one or more patient responses, wherein the one or more patient responses are provided by the patient in response to one or more queries or commands posed to the patient by the sepsis analysis system, and wherein the one or more queries or commands are configured to elicit, in the one or more patient responses, information relevant to the patient's sepsis status; (iv) analyze, by the trained patient sepsis status model, the received demographic information, the received observation data, and the one or more patient responses to predict a sepsis status for the patient;
The limitations to “receive” and “analyze” information and data, by a processor, are
merely insignificant extra-solution activity since the limitation amounts to necessary data gathering and outputting, (i.e., all uses of the recited judicial exception require such data gathering or data output). See Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; OIP Techs., Inc. v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1092-93 (Fed. Cir. 2015) (presenting offers and gathering statistics amounted to mere data gathering). In addition to data gathering, the limitations to “receive” and “analyze” data to make an assessment or prediction based on the data comprise method steps that are merely implementation of a method on a generic system, such as a processor.
The implementation of a mental process on a generic computer (in this case, once the mental process cited above is performed, one can readily ascertain how the mentally calculated data may be entered in a generic processor for receiving and analyzing data for making a prediction based on the data) provide no improvement to the functioning of a computer system as known in the medical art, thus as noted in MPEP 2106.05(a) the limitations do not amount to an improvement in the functioning of a computer. Similarly, these limitations comprises well-understood, routine and conventional activity with a processor, where it is common to have computer devices receive, evaluate and make “recommendations” or “implement” a change based on the data. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application. Accordingly, even in combination, the additional element noted above (processor) do not integrate the abstract idea into a practical application. The claim is directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. There is no recitation of an additional element (or combination of elements) that integrate the abstract idea of a mental process into a practical application. The claimed limitations merely “receive” and “analyze” information to determine the predicted sepsis status for the patient to “provide” for “reporting”. There is no improvement in the functioning of a computer, or an improvement to other technology or technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); Or applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2). Thus, the limitations to receive and analyze data, by a processor is considered executing a mental process by using a generic computer component (processor). As discussed with respect to Step 2A Prong Two, the additional element in the claim are mere instructions to apply the exception using a generic computer component (processor). The same analysis applies here in 2B and does not provide an inventive concept.
Dependent claims:
Claims 2-10 and 12-15 are dependent claims that further limit the method into steps relating to monitoring and revising the data through a mental process. Accordingly, these claims do not integrate the abstract idea into a practical application for similar reason to claims 1 and 11. These limitations comprise well-understood, routine and conventional activity in the medical diagnostic and treatment devices, where it is common to have computer devices evaluate and “recommend or implement” changes to treatment based on the sensed data. Thus by MPEP 2106.05(d) these steps do not comprises integration of the mental process into practical application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 11-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 11 recites “a processor configured to: … receive, at the sepsis analysis system, observation data from a patient monitoring device”. It is unclear if the “sepsis analysis system” is part of the processor or is a separate component in communication with the processor. Further clarification is requested.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Barkol et al. (US 20190355447 A1) in view of Goetz (US 20050060008 A1).
As to claims 1 and 11, Barkol et al. discloses predicting a sepsis status of a patient using a sepsis analysis system (collaborative space server system, depicted as 102 in Figure 1; [0027, 0031, 0034]) comprising: receiving, from a patient database (EMR database, depicted as 122 in Figure 1; [0034]), demographic information about the patient ([0029]; Figure 1); receiving, at the sepsis analysis system (collaborative space server system, depicted as 102 in Figure 1; [0025, 0027]), observation data ([0025]; “The monitoring devices 120 may include traditional medical devices monitoring respective patients, such as pulse oximeters, heart rate monitors, blood glucose monitors, ECGs, and medical imaging modalities (e.g., ultrasound, CAT, MRI), as well as microphones, cameras, and other devices”) from a patient monitoring device (depicted as 120 in Figure 1; [0036]); analyzing, by a trained patient sepsis status model (VHA; [0041]) of the sepsis analysis system, the received demographic information, the received observation data, and the one or more patient responses to predict a sepsis status for the patient ([0034, 0037, 0041]); and reporting, via a user interface of the sepsis analysis system ([0099]), the predicted sepsis status for the patient ([0041, 0097]).
Barkol et al. discloses the invention substantially as claimed with receiving patient responses ([0035-0036]) by the sepsis analysis system information relevant to the patient's sepsis status ([0035-0037]) but does not explicitly disclose the patient responses are provided “in response to one or more queries or commands posed to the patient” with “the one or more queries or commands are configured to elicit, in the one or more patient responses, information relevant to the patient's sepsis status”. Goetz discloses one or more queries or commands posed to the patient regarding the efficacy of treatment, collecting patient input and utilizing the patient responses to optimize treatment ([0078]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the user interface of the sepsis analysis system of Barkol et al. to include providing prompts or quires to the patient to elicit one or more patient responses as disclosed by Goetz in order to provide the predictable results of collecting patient input as to their current state or well-being for enhanced diagnostics to meet specific patient therapeutic needs and requirements.
As to claim 2 and 12, the modified Barkol et al. discloses the invention substantially as claimed with received observation data and the one or more patient responses to predict a sepsis status for the patient but does not explicitly disclose the observation data and patient responses “are received from a post-discharge patient”. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the data collection from a patient in modified Barkol et al. to also include a discharged patient (post-discharge) in order to provide the predictable results of continuing patient observation post-discharge to ensure the patient continues to maintain their health and well-being.
As to claim 3, the modified Barkol et al. discloses the patient monitoring device (depicted as 120 in Figure 1; [0025]) is a wearable device ([0025]; traditional medical devices for monitoring the patient are external to the patient and thus considered to be “wearable” by the patient).
As to claim 4, the modified Barkol et al. discloses the demographic information comprises one or more of: (i) dietary information, (ii) diagnosis information, and (iii) electronic medical record information ([0029]; EMR information), and wherein the observation data comprises one or more of the patient's heart rate, an ECG, blood pressure, respiration rate, PPG, and temperature ([0025]).
As to claim 5, as stated above, the modified Barkol et al. discloses “collecting patient input as to their current state or well-being for enhanced diagnostics to meet specific patient therapeutic needs and requirements”. Therefore, the modified Barkol et al. discloses “the one or more queries or commands comprise a request for symptom information from the patient”.
As to claims 6 and 13, the modified Barkol et al. discloses the step of analyzing the received observation data to identify any data that may indicate possible patient sepsis (Figure 1; [0033-0034, 0041]).
As to claims 7 and 14, the modified Barkol et al. discloses the step of generating one or more queries or commands to pose to the patient, wherein the one or more queries or commands are generated based at least in part on the received observation data (Goetz, [0010, 0078, 0082-0086]).
As to claim 8, the modified Barkol et al. discloses the one or more patient responses are received from the patient monitoring device or from a patient smartphone (Goertz, [0078, 0087]; Figure 1).
As to claim 9, as stated above, the modified Barkol et al. discloses “collecting patient input as to their current state or well-being for enhanced diagnostics to meet specific patient therapeutic needs and requirements”. Therefore, the modified Barkol et al. discloses “the one or more patient responses are analysed for patient sentiment”. Additionally, Goetz discloses “efficacy ratings can be obtained by verbal feedback from the patient concerning therapeutic benefit and side effects, marking of a pain/parasthesia map, objective measurement using pain rating scales, quantification of side effects, a combination of the forgoing, or other observation techniques”. As such the modified Barkol et al. discloses “the one or more patient responses are analysed for patient sentiment”.
As to claims 10 and 15, the modified Barkol et al. discloses the step of storing in a patient profile and/or patient database, some or all of the received observation data and the one or more patient responses(Barkol et al., [0051, 0098-0099]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796