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
This Office Action is responsive to the application filed July 11, 2025.
Claims 23 and 36 have been amended.
Claims 23-42 are currently pending and have been fully examined.
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 23-42 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.
The term “more prominently” in claims 23 and 36 is a relative term which renders the claim indefinite. The term “more prominently” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Though the specification contemplates various manners in which to distinguish patients, the specification does not provide a way to ascertain what is “more prominent”. For example, is the use of a different color, size, animation, etc. considered to be “more prominent” or is the lack or absence of color, animation, etc. considered to be “more prominent”?
Further, claim 36 also recites a step where graphical representations are moved where patients with new higher risk score requiring monitoring ‘to be displayed above and more prominently than’ graphical representations representing new lower risk score patients requiring monitoring. It is unclear whether the relative location of the graphical representation (e.g., above or below) is what “more prominently” refers to, or if “more prominently” refers to something else. “Different” does not inherently equate to “more prominent”. For purposes of examination “more prominently” is interpreted as referring to the location within the display, as a higher risk score patient will be displayed “above” or “before” a lower risk score in a ranked order.
Claims 24-35 and 37-42 ultimately depend on claims 23 and 36 without resolving the issue of “more prominently” and thus are also rejected.
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 23-42 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claims 23-35 are not directed towards a statutory category of invention. Per MPEP 2106.03, a machine (e.g., apparatus) is a “concrete thing, consisting of parts, or of certain devices and combination of devices.” Digitech, 758 F.3d at 1348-49, 111 USPQ2d at 1719 (quoting Burr v. Duryee, 68 U.S. 531, 570, 17 L. Ed. 650, 657 (1863)). This category “includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result.” Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 (quoting Corning v. Burden, 56 U.S. 252, 267, 14 L. Ed. 683, 690 (1854)).
Claim 23 recites “a plurality of hospitals” as an element of the claimed system. A hospital is a building or location and is not a (mechanical) device. Examiner suggests amending claim 23 to remove “a plurality of hospitals” as an element of the claimed system, and utilize language similar to that of claim 36, where the “plurality of hospitals” is referenced as the location of the monitoring equipment from which data streams are received rather than a positively recited element or limitation of the claim. For the purposes of compact prosecution, claim 23 will be further evaluated as an apparatus claim for subject matter eligibility.
Step 1
The claim(s) recite(s) subject matter within a statutory category as a machine (claim 23) and a process (claim 36) which are recited as systems and methods that perform the following limitations:
receive a data stream associated with each of the patients requiring monitoring from the network of each of the plurality of hospitals in real time, wherein the data stream comprises the at least one vital sign for each of the patients requiring monitoring;
determine a risk score associated with each of the patients requiring monitoring based on the data stream at a given time;
categorize the risk scores for each of the patients requiring monitoring based on acuity at the given time; and
[claim 23] alter the graphical representations corresponding to each of the patients requiring monitoring …to more prominently display the graphical representation of each of the patients requiring monitoring having the most acute risk scores at the given time, wherein the GUI is continuously refreshed based on the data stream.
[claim 36] display the graphical representations corresponding to each of the patients requiring monitoring … to more prominently display the graphical representation of each of the patients requiring monitoring having the most acute risk scores at the given time
Step 2A: Prong 1
When taken individually and as a whole, the steps correspond to concepts identified as abstract ideas by the courts, such as “mathematical concepts”, which are concepts mathematical relationships, mathematical formulas or equations, mathematical calculations.
The claim is directed to a system configured to perform the process of calculating patient risk scores and categorizing patients based on the risk scores, which is performed by the system performing the above underlined limitations of the claimed invention. Determining a risk score is performing a mathematical calculation (see specification, par. [0048], which describes the risk score as possibly being a sum of three individual components. Performing a sum is performing a mathematical calculation; see also par. [0050], which gives examples of mathematical calculations that could be performed). Categorizing the risk scores is determining a mathematical relationship between the numbers and grouping them accordingly (e.g., setting up threshold levels for low, medium, and high risk, and then assigning the patients to the proper category based on the relationship between the risk score value and the threshold values for the categories is identifying mathematical relationships).
Further, these steps correspond to “certain methods of organizing human activity”. Multiple patients are monitored in order to determine a risk score which is displayed, to the patient and/or medical provider. These steps amount to the rules or instructions followed to generate medical alerts for the caretaking of patients.
Step 2A: Prong 2
Independent claims 23 and 36 contain the following additional elements:
A plurality of hospitals, each having at least one patient requiring monitoring
At least one piece of monitoring equipment connected to each of the patients requiring monitoring, wherein at least two of the plurality of hospitals use monitoring equipment from different manufacturers
A network connected to each of the at least one piece of monitoring equipment;
A remote monitoring center configured to monitor each of the patients requiring monitoring at each of the plurality of hospitals and connected to the network of each of the plurality of hospitals
At least one graphical user interface (GUI) configured to display graphical representations corresponding to each of the patients requiring monitoring;
A computing device linked to the GUI
A memory storing computer executable instructions and configured to execute the computer executable instructions
The claims do not include additional elements that are sufficient to be considered a practical application because the additional elements amount to: insignificant extra-solution activity (MPEP 2106.05(g)), mere instructions to apply it with a computer (MPEP 2106.05(f)), or generally linking the application of the abstract idea to a particular field of use or technological environment (2106.05(h)), as discussed below.
Insignificant Extra-Solution Activity
The limitations that describe the specific type of information to be received and accessed (e.g., the data stream being “associated with each of the patients requiring monitoring from the network of each of the plurality of hospitals in real time, wherein the data stream comprises the at least one vital sign for each of the patients requiring monitoring”). Selecting by type or source the information to be manipulated has been determined to be an insignificant extra-solution activity (MPEP 2106.05(g)).
The step of receiving a data stream associated with a non-critically ill hospitalized patient is mere data gathering by retrieving data over a network. Mere data gathering has been determined to be an insignificant extra-solution activity (MPEP 2106.05(g)). The information contained within the data stream (e.g., the at least one vital sign for each of the patients requiring monitoring) does not impact this finding. The step of displaying a plurality of graphical representations, each displaying a clinical status corresponding to a unique non-critically ill hospitalized patient describes necessary outputting of data, which is also an insignificant extra-solution activity (MPEP 2106.05(g)).
The steps of altering the display are examples of necessary data outputting because they recite displaying the results of the abstract idea (i.e., the patients and their associated risk category) at a high degree of generality. (MPEP 2106.05(g)) Necessary data outputting is an example of an insignificant extra-solution activities that is not sufficient to integrate the abstract idea into a practical application or cause the claim to amount to significantly more than the abstract idea (MPEP 2106.05(g)). Claim 23 does not specify any methodology or way in which the graphical representations are “altered”. Claim 36 moves graphical representations representing patients with a higher risk score requiring monitoring is displayed above and more prominently than graphical representation representing lower risk score patients requiring monitoring. In view of the interpretation explained above (in the 112B rejection), this is deemed to simply output the results of ranking the patients by their risk score in sequential order.
Mere Instructions to Apply
The steps reciting the use of computer components in performing the steps only serve as mere instructions to apply the abstract idea using a computer (MPEP 2106.05(f)). Mere instructions to apply the abstract idea using a computer are not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(f)).
Generally Linking the Application of the Abstract Idea to a Particular Field of Use or Technological Environment
Claims 23 and 35 specify that there are a plurality of hospitals, network, monitoring centers in which the claimed invention is implemented, which only serves to establish a general link to a physical environment. Similarly, claims 23 and 35 both specify that at least two of the hospitals use monitoring equipment from different manufacturers. As explained by the Supreme Court, a claim directed to a judicial exception cannot be made eligible “simply by having the applicant acquiesce to limiting the reach of the patent for the formula to a particular technological use.” Diamond v. Diehr, 450 U.S. 175, 192 n.14, 209 USPQ 1, 10 n. 14 (1981). Thus, limitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application. (MPEP 2106.05(h)).
Step 2B
The claims also do not include additional elements that are sufficient to be considered a significantly more than the abstract idea because the additional elements amount to: insignificant extra-solution activity (MPEP 2106.05(g)), mere instructions to apply it with a computer (MPEP 2106.05(f)), generally linking the application of the abstract idea to a particular field of use or technological environment (MPEP 2106.05(h)), or a well-understood, routine, and conventional limitation (MPEP 2106.05(d)), as discussed below.
The steps addressed above in Step 2A: Prong 2, when considered again under Step 2B are not considered to make the claims amount to significantly more than the abstract idea because those steps, when considered additionally with regards to Step 2B, are still considered to be either insignificant extra-solution activity, mere instructions to apply an abstract idea with a computer, or generally linking the application of the abstract idea to a particular field of use or technological environment, which are types of limitations that are not sufficient to make the claims amount to significantly more than the abstract idea (MPEP 2106.05.I.A).
The recited computer components (e.g., the graphical user interface, non-transitory memory storing computer executable instructions, and processor coupled to the memory and configured to execute the computer executable instructions) are all generically recited components (see specification, par. [0048]). Generic computer components or specially-programmed computer components performing the functions of a generic computer are not considered to be/amount to significantly more than the abstract idea (MPEP 2106.05(b)). Similarly, the monitoring equipment recited in the claims is not disclosed as being particular or specific, beyond that they could be manufactured by different vendors. In fact, paragraph 49 of the specification states that the receiver can be vendor agnostic and capable of receiving a data stream from any one of a number of vendors of monitoring equipment. Thus, these are also considered to be generic in nature and are not considered to amount to significantly more than the abstract idea.
When considered as a whole, the components do not provide anything that is not present when the component parts are considered individually. Using the broadest reasonable interpretation, the system as a whole is a processor, which can be a generic computing device (see specification par. [0048]), coupled to a memory that executes instructions to receive data over a network. The data received by the system is then evaluated perform the mathematical calculation (i.e., determine the risk score) based on the data that was received. The system then outputs the data as part of a graphical user interface, where the outputting and ordering of the interface are insignificant extra-solution activities (MPEP 2106.05(g)).
Accessing data over a network is a well-understood, routine, and conventional function of a generic computer (MPEP 2106.05(d)(II). This is a system configured to receive data over a network in order to implement the abstract idea and insignificant extra-solution activity. Therefore, the system is an ordered combination of generic computer components performing well-understood, routine, and conventional functions of a computer to implement an abstract idea, which is not significantly more than the abstract idea.
Dependent Claim Analysis
Claims 24-35 are ultimately dependent from Claim(s) 23 and includes all the limitations of Claim(s) 23. Therefore, claim(s) 24-35 are directed towards the same abstract idea as claim 23.
Claims 24 and 32 recite limitations that amount to necessary data outputting because they describe outputting the results of the analysis performed to either members of the care team or to an electronic health record of the patient. Necessary data outputting is an insignificant extra-solution activity that is not sufficient to integrate the abstract idea into a practical application or amount to significantly more (MPEP 2106.05(g)).
Claims 25 and 34 recite limitations that serve to further describe the abstract idea by describing additional mathematical concepts to be performed by the claimed invention (e.g., claim 25 defines the categories for the risk scores and claim 34 describes the mathematical concepts used to generate the risk scores). Limitations that are part of the abstract idea or additional elements that also recite abstract ideas are not sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.04.II.A.2).
Claims 27, 29-31, 33, and 35 all recite limitations that amount to selecting by type the data to be manipulated by describing specific types of information that are to be used for the analysis performed. Selecting by type the data to be manipulated is an insignificant extra-solution activity that is not sufficient to integrate the abstract idea into a practical application or amount to significantly more (MPEP 2106.05(g)).
Claim 28 recites limitations that amount to instructions to apply the abstract idea using a computer because it describes using the computer system to perform elements of the abstract idea. Mere instructions to apply are not considered sufficient to integrate the abstract idea into a practical application or amount to significantly more than the abstract idea (MPEP 2106.05(f)).
Claims 37-42 are ultimately dependent from Claim(s) 36 and includes all the limitations of Claim(s) 36. Therefore, claim(s) 37-42 are directed towards the same abstract idea as claim 36.
Claims 37-42 recite limitations that are the same or substantially similar to the limitations of claims 24, 33-34, and 30-32, respectively. Claims 38-42 are rejected for the same reasons as claims 24, 33-34, and 30-32.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 23, 25-36 and 38-42 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 3-5, and 9-10 of U.S. Patent No. 11,557,383 (hereafter the ‘383 Patent) in view of Muhsin (US PGPub 20110169644) in view of Wolgin (US PGPub 20170165040).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the present application obvious in view of the claims of the ‘383 Patent.
With few exceptions, the limitations of the independent claim 23 are the same or substantially similar to limitations of claim 1 of the ‘383 Patent. Claim 23 further recites “a plurality of hospitals, each having at least one patient requiring monitoring and each comprising at least one piece of monitoring equipment connected to each of the patients requiring monitoring, wherein at least two of the plurality of hospitals use monitoring equipment from different manufacturers; and a network connected to each of the at least one piece of monitoring equipment”.
Muhsin teaches a system comprising:
a plurality of hospitals, each having at least one patient requiring monitoring ([0021] - the various devices 120, 130, 140, and 150 of the clinical network environment 100 may be geographically distributed (e.g., among multiple hospitals));
at least one piece of monitoring equipment connected to each of the patients requiring monitoring ([0022] - The patient monitors 140 may be point-of-care (POC) instruments or the like that monitor physiological signals detected by sensors coupled with medical patients. The patient monitors 140 may process the signals to determine any of a variety of physiological parameters.), and
a network connected to each of the at least one piece of monitoring equipment ([0020] - The clinical network environment 100 includes a multi-patient monitoring system (MMS) 120 in communication with one or more patient monitors 140, nurses' station systems 130, and clinician devices 150 over a network 110);
Wolgin teaches at least two of the plurality of hospitals use monitoring equipment from different manufacturers ([0018] - many hospitals carry various vacuum machines of many different manufacturer types, which may also be suitable for use with the present invention).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the ‘383 patent to incorporate multiple hospitals, monitoring equipment connected to a network, as taught by Muhsin and using monitoring equipment from different manufacturers, as taught by Wolgin, because doing so is essentially a duplication in parts, which has no patentable significance without a new and unexpected result. In reHarza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960)
Claim 25 reads on the limitation of claim 1 of the ‘383 patent that reads, “categorize the risk score associated with the one of the plurality of non- critically ill hospitalized patients as one of high, medium, or low, wherein the risk score is categorized by comparing the risk score to at least two thresholds set by the remote monitoring center”.
Claim 26 reads on the limitation of claim 1 of the ‘383 patent that reads, “A system comprising: a graphical user interface in a remote monitoring center comprising a display of a plurality of graphical representations”.
Claim 27 reads on the limitation of claim 1 of the ‘383 Patent that reads, “each of the plurality of graphical representations displaying a clinical status corresponding to a unique non-critically ill hospitalized patient”.
Claim 28 reads on the limitation of claim 1 of the ‘383 Patent that reads, “wherein each of the plurality of graphical representations is expandable to a detailed view comprising parameters corresponding to the clinical status corresponding to the unique non-critically ill hospitalized patient”. This shows that the patients are selectable within the GUI and will alter the GUI to display data related to that patient.
Claim 29 reads on the limitation of claim 2 of the ‘383 Patent that reads, “wherein the detailed view comprises real-time ECG waveform data, stored alarmed ECG data, bedside monitoring vendor alarms history, trended vitals data, and a communication link to a bedside clinical provider”
Claim 30 is anticipated by the limitation of claim 1 of the ‘383 Patent that reads, “wherein each of the plurality of graphical representations is expandable to a detailed view comprising parameters corresponding to the clinical status corresponding to the unique non-critically ill hospitalized patient”.
Claim 31 reads on the limitation of claim 2 of the ‘383 Patent that reads, “wherein the processor quantifies a responsiveness of the monitoring technician based on a time to view the detailed view of the parameters triggering the risk score.”
Claim 32 reads on the limitation of claim 4 of the ‘383 Patent that reads, “wherein each graphical representation is linked to an electronic medical record (EMR) of the corresponding unique non-critically ill hospitalized patient”.
Claim 33 reads on the limitation of claim 1 of the ‘383 Patent that reads, “wherein the data stream comprises at least two vital signs associated with the one of the plurality of non-critically ill hospitalized patients and an alarm notification associated with the one of the plurality of non-critically ill hospitalized patients”.
Claim 34 is anticipated by the limitation of claim 7 of the ‘383 Patent that reads, “wherein the trends are determined based on summing scaled differences between the at least two vital signs and moving averages of the at least two vital signs over a time period scaled” and the limitation of claim 1 that reads, “wherein the priority of the triggered alarm is based on a vendor and an assigned weighted value derived based on historical clinical outcomes data of the triggered alarm”.
Claim 35 reads on the limitation of claim 1 of the ‘383 Patent that reads, “wherein the risk score indicates whether an alarm associated with the alarm notification is actionable or not actionable based on a likelihood of the non-critically ill hospitalized patient developing an actionable clinical event”.
Claim 36 is a method claim that recites limitations that are the same or substantially similar to the limitations of claim 23 as they pertain to the limitations of the method claim 15 of the ‘383 Patent.
Claims 38-42 of the present application recite limitations that are the same or substantially similar to the limitations of claims 33-34 and 30-32 of the present application, respectively. Claims 38-42 are anticipated by the ‘383 Patent for the same reasons as claims 33-34 and 30-32.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 23- 33, 37-38, 40-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Muhsin (US PGPub 20110169644) in view of Wolgin (US PGPub 20170165040).
As per claim 23, Muhsin teaches a system comprising:
a plurality of hospitals, each having at least one patient requiring monitoring ([0021] - the various devices 120, 130, 140, and 150 of the clinical network environment 100 may be geographically distributed (e.g., among multiple hospitals));
at least one piece of monitoring equipment connected to each of the patients requiring monitoring ([0022] - The patient monitors 140 may be point-of-care (POC) instruments or the like that monitor physiological signals detected by sensors coupled with medical patients. The patient monitors 140 may process the signals to determine any of a variety of physiological parameters.), and
a network connected to each of the at least one piece of monitoring equipment ([0020] - The clinical network environment 100 includes a multi-patient monitoring system (MMS) 120 in communication with one or more patient monitors 140, nurses' station systems 130, and clinician devices 150 over a network 110);
a remote monitoring center configured to monitor each of the patients requiring monitoring at each of the plurality of hospitals and connected to the network of each of the plurality of hospitals ([0003] - Alarms and other physiological information are often transmitted to a central nurses' station or the like, where nurses or other clinicians can monitor several patients at once; [0021] - the various devices 120, 130, 140, and 150 of the clinical network environment 100 may be geographically distributed (e.g., among multiple hospitals); [0028] - The MMS 120 in certain embodiments includes one or more physical computing devices, such as servers, having hardware and/or software for managing network traffic in the network 110; [0030] - Upon connecting to a patient monitor 140, the MMS 120 may receive physiological information and medical events from the patient monitors 140. The MMS 120 may provide at least a portion of the physiological information and events to the nurses' station systems 130 and/or clinician devices 150. For example, the MMS 120 may provide physiological data and alarms for a plurality of patient monitors 140 to a nurses' station system 130, where nurses can evaluate the data and/or alarms to determine how to treat patients);
at least one graphical user interface (GUI) configured to display graphical representations corresponding to each of the patients requiring monitoring ([0025] - the nurses' station computers 130 can receive and display physiological information and alarm data received from the MMS 120 (or monitors 140). In certain embodiments, the nurses' station computers 130 use a graphical user interface (GUI) that provides a streamlined, at-a-glance view of physiological and medical information]); and
a computing device linked to the GUI ([0025] - the nurses' station computers 130 can receive and display physiological information and alarm data received from the MMS 120 (or monitors 140). In certain embodiments, the nurses' station computers 130 use a graphical user interface (GUI) that provides a streamlined, at-a-glance view of physiological and medical information) comprising:
a memory storing computer executable instructions; and a processor coupled to the memory and configured to execute the computer executable instructions ([0025] - The nurses' station systems 130 can be desktop computers, laptops, work stations, or the like that are located at a nurses' station; [0132-0133] - The various illustrative logical blocks, modules, and circuits described in connection with the embodiments disclosed herein may be implemented or performed with a general purpose processor…. A general purpose processor may be a microprocessor, but in the alternative, the processor may be any conventional processor, controller, microcontroller, or state machine. A processor may also be implemented as a combination of computing devices, e.g., a combination of a DSP and a microprocessor, a plurality of microprocessors, one or more microprocessors in conjunction with a DSP core, or any other such configuration…. The steps of a method or algorithm described in connection with the embodiments disclosed herein may be embodied directly in hardware, in a software module executed by a processor, or in a combination of the two. A software module may reside in RAM memory, flash memory, ROM memory, EPROM memory, EEPROM memory, registers, hard disk, a removable disk, a CD-ROM, or any other form of storage medium known in the art) to at least:
receive a data stream associated with each of the patients requiring monitoring from the network of each of the plurality of hospitals in real time, wherein the data stream comprises the at least one vital sign for each of the patients requiring monitoring ([0063] - Stream-based data can be obtained from one or more physiological monitors (including patient monitors 140, 240) configured to provide continuous data, or waveforms, indicative of a physiological condition of a medical patient. Different physiological monitors may provide the continuous data at different data rates or frequencies; [0110] - The patient monitor view area 720 is currently receiving physiological information from a patient. The patient monitor view area 720 displays the real-time values of various physiological parameters that are being monitored for a selected patient.);
determine a risk score associated with each of the patients requiring monitoring based on the data stream at a given time ([0120] - Overall health or wellness may be determined based upon the combined effect of each of the monitored physiological parameters. The patient's overall health may be represented as a risk value between 0-10, where 0 is low risk of an adverse event and where 10 is high risk of an adverse event);
categorize the risk scores for each of the patients requiring monitoring based on acuity at the given time ([0120] - Different colors may be used to graphically illustrate when the risk value exceeds certain threshold levels); and
alter the graphical representations corresponding to each of the patients requiring monitoring on the GUI to more prominently display the graphical representation of each of the patients requiring monitoring having the most acute risk scores at the given time, wherein the GUI is continuously refreshed based on the data stream ([0108] – Currently available graphical user interfaces for nurses' station computers tend to show a plurality of wave forms or changing physiological parameter numbers for each patient. This method of displaying patient information can be cluttered, confusing, and even hypnotic in some situations. Nurses working on a night shift, for instance, may find it difficult to concentrate on an alarm when several other patients' indicators on the display have changing numbers, changing waveforms, or the like. In contrast, in the graphical interface herein described, when the graphical status indicator 714 indicates an alarm condition, this alarm condition can stand out and be immediately recognized by the clinician; [0120] - Different colors may be used to graphically illustrate when the risk value exceeds certain threshold levels. For example, the waveform shown in the lower portion 745 may be filled blue for values less than 1, but red for values greater than 7, with different colors for different bands in between. Such coloring is illustrated by the different fill patterns within the waveform shown in the lower portion 745 of the analysis panel 730 of FIG. 11.).
Muhsin does not explicitly teach wherein at least two of the plurality of hospitals use monitoring equipment from different manufacturers. However, this is taught by Wolgin ([0018] - many hospitals carry various vacuum machines of many different manufacturer types, which may also be suitable for use with the present invention). It is further noted that, despite the manufacturer being different, there is no change in the functioning of the monitoring equipment or the data obtained or collected by the equipment, and is more of a description of the operating environment rather than a limitation that imparts functional or patentable weight that limits the scope of the claim.
Both Muhsin and Wolgin teach the use of collecting patient information using monitoring equipment with multiple patients geographically dispersed among multiple hospitals and using the collected information to treat a patient condition; thus they are deemed to be analogous references as they are directed to the same field of endeavor. It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the teachings of Muhsin to incorporate or integrate the data obtained from monitoring equipment from different manufacturers, as taught by Wolgin, because doing so broadens the usability of Muhsin to allow it to be utilized across hospitals regardless of the maker of the monitoring equipment used or installed at each hospital, as acknowledged by Wolgin ([0018]).
As per claim 24, Muhsin teaches the system of claim 23, wherein when the processor is further configured to send an alert to one or more members of a bedside care team associated with each of the patients requiring monitoring having the most acute risk scores ([0023-0025] - The patient monitors 140 can also provide information on medical events, such as alarms, to the MMS 120. Alarms can be triggered, for example, in response to a physiological parameter falling outside of a normal range…. The nurses' station computers 130 can receive and display physiological information and alarm data received from the MMS 120 (or monitors 140).).
As per claim 25, Muhsin teaches the system of claim 23, wherein the processor is further configured to categorize the risk scores into a high category, a medium category, or a low category based on the acuity ([0120] - Overall health or wellness may be determined based upon the combined effect of each of the monitored physiological parameters. The patient's overall health may be represented as a risk value between 0-10, where 0 is low risk of an adverse event and where 10 is high risk of an adverse event) {medium risk falling between low risk and high risk}.
As per claim 26, Muhsin teaches the system of claim 23, wherein the GUI is a part of a central monitoring station at the remote monitoring center ([0003] - Alarms and other physiological information are often transmitted to a central nurses' station or the like, where nurses or other clinicians can monitor several patients at once; [0025] - One or more nurses' station computers 130 can be located at a single nurses' station. The nurses' station computers 130 can receive and display physiological information and alarm data received from the MMS 120 (or monitors 140). In certain embodiments, the nurses' station computers 130 use a graphical user interface (GUI) that provides a streamlined, at-a-glance view of physiological and medical information; [0103] - The GUI 700 can be provided on any display. For example, the GUI 700 can be provided over the Internet to a remote user).
As per claim 27, Muhsin teaches the system of claim 23, wherein the graphical representations of each of the patients requiring monitoring comprise a display of a clinical status for each of the patients requiring monitoring ([0104] - he GUI 700 includes a patient status display area 710, sometimes referred to as the patient dashboard, or just dashboard. The patient status display area 710 shows the status of multiple patients in a hospital or other clinical location. In an embodiment, patient status display area 710 depicts patient status for patients in a hospital department. Advantageously, in certain embodiments, the patient status display area 710 provides an “at-a-glance” view of multiple patients' health status).
As per claim 28, Muhsin teaches the system of claim 23, wherein the graphical representations of each of the patients requiring monitoring is selectable, wherein when one of the graphical representations is selected the processor is further configured to alter the GUI to display detailed data related to that patient of the one of the graphical representations ([0110] - the patient status modules 712 can be selected by a single mouse click, touching a screen or monitor displaying the GUI 700, or the like. Selecting a patient status module 712 in one embodiment can bring up a patient monitor view area 720).
As per claim 29, Muhsin teaches the system of claim 28, wherein the detailed data related that patient comprises at least one of: one or more parameters triggering the risk score for that patient, real-time ECG waveform data, stored alarmed ECG data, bedside monitoring vendor alarms history, trended vitals data, or a communication link to a bedside clinical provider ([0041-0042] - The monitoring module 242 can monitor physiological signals generated by one or more sensors coupled with a patient. The monitoring module 242 may process the signals to determine any of a variety of physiological parameters. For example, the monitoring module 242 can determine physiological parameters such as pulse rate, plethysmograph waveform data, perfusion index, and values of blood constituents in body tissue, including for example, arterial carbon monoxide saturation (“HbCO”), methemoglobin saturation (“HbMet”), total hemoglobin (“HbT” or “SpHb”), arterial oxygen saturation (“SpO2”), fractional arterial oxygen saturation (“SpaO2”), oxygen content (“CaO2”), or the like.. the monitoring module 242 may obtain physiological information from acoustic sensors in order to determine respiratory rate, inspiratory time, expiratory time, inspiration-to-expiration ratio, inspiratory flow, expiratory flow, tidal volume, minute volume, apnea duration, breath sounds, rales, rhonchi, stridor, and changes in breath sounds such as decreased volume or change in airflow. In addition, in some cases the monitoring module 242 monitors other physiological sounds, such as heart rate (e.g., to help with probe-off detection), heart sounds (e.g., S1, S2, S3, S4, and murmurs), and changes in heart sounds such as normal to murmur or split heart sounds indicating fluid overload. Moreover, the monitoring module 242 may monitor a patient's electrical heart activity via electrocardiography (ECG) and numerous other physiological parameters; [0111] - A history view area 730 (sometimes referred to as the analysis panel 730) in certain implementations can show medical event data corresponding to a selected patient monitor status module 712…. The history view area 730 can also be configured to show historical trend, waveform, or patient wellness data obtained from an RRDB over a desired time period instead of, or in addition to, the journaled medical event data).
As per claim 30, Muhsin teaches the system of claim 29, wherein the detailed data is shown in a detailed view of the graphical representation that is displayed upon selection of the graphical representation ([0110] - the patient status modules 712 can be selected by a single mouse click, touching a screen or monitor displaying the GUI 700, or the like. Selecting a patient status module 712 in one embodiment can bring up a patient monitor view area 720).
As per claim 31, Muhsin teaches the system of claim 28, wherein the processor quantifies a responsiveness of the monitoring technician based on a time to view the detailed data of the graphical representation corresponding to each of the patients requiring monitoring having the most acute risk scores at the given time ([0037] - the MMS 120 is programmed to periodically review response time by a particular healthcare practitioner. If the response time exceeds a particular threshold, the MMS 130 modifies a device's alarm setting by increasing its volume level, changing its tone, or by raising (or lowering) the alarm's threshold level).
As per claim 32, Muhsin teaches the system of claim 23, wherein the processor links each graphical representation corresponding to each patient requiring monitoring to an electronic health record associated with each of the patients requiring monitoring ([0038] - administrative devices may also allow IT staff to interface third-party systems with the MMS 120, such as electronic medical record (EMR) systems; [0069] - data from the RRDB (including patient record (See FIG. 4) and waveform data) is written to the patient's electronic medical record (“EMR”) (not shown)… the MMS 120, 220 could be configured to send or store such data to the patient's EMR only when the quality of the data and/or the confidence in its accuracy exceeds a predetermined threshold level; [0112] - FIG. 8 illustrates another embodiment of the GUI 700 in which the history view area (or analysis panel) 730 is configured to display trend data associated with a selected medical patient over a selected time period. The trend data can be retrieved from a round-robin database, as discussed above).
As per claim 33, Muhsin teaches the system of claim 23, wherein the data stream comprises at least two vital signs ([0063] - Stream-based data can be obtained from one or more physiological monitors (including patient monitors 140, 240) configured to provide continuous data, or waveforms, indicative of a physiological condition of a medical patient. Different physiological monitors may provide the continuous data at different data rates or frequencies; [0110] - The patient monitor view area 720 is currently receiving physiological information from a patient. The patient monitor view area 720 displays the real-time values of various physiological parameters that are being monitored for a selected patient) and an alarm from one of the at least one piece of monitoring equipment connected to each patient requiring monitoring ([0003] - Alarms and other physiological information are often transmitted to a central nurses' station or the like; [0023-0025] - The patient monitors 140 can also provide information on medical events, such as alarms, to the MMS 120. Alarms can be triggered, for example, in response to a physiological parameter falling outside of a normal range…. The nurses' station computers 130 can receive and display physiological information and alarm data received from the MMS 120 (or monitors 140)).
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Muhsin (US PGPub 20110169644) in view of Wolgin (US PGPub 20170165040) in further view of Hebler (US PGPub 20130027411) and Swedlow (US PGPub 2002/0095077).
As per claim 34, Mushin and Wolgin teaches the system of claim 33, but does not explicitly teach wherein the risk scores of each of the patients requiring monitoring are determined by summing at least a vitals trending risk score determined based on values associated with the at least two vital signs and an alarm input risk score determined based on a value a vendor of the at least one piece of monitoring equipment connected to each patient requiring monitoring assigned to the alarm.
However, Hebler teaches the risk scores of each of the patients requiring monitoring are determined by summing at least a vitals trending risk score determined based on values associated with the at least two vital signs ([0032-0034] - The patient EWS score is thus determined by summing the sub-scores of each of the measured values in the physiological data, or using the worst case of the individual sub-scores or other rule definitions defined by the scoring schema (e.g., aggregated MEWS and single parameter score)), and Swedlow teaches an alarm input risk score determined based on a value a vendor of the at least one piece of monitoring equipment connected to each patient requiring monitoring assigned to the alarm ([0028-0032] - The oximeter monitor instrument may also write the alarm limits used with a particular patient into memory chip 56. Alarm limits are values that represent maximum or minimum values of patient trending data tracked by the oximeter (such as blood oxygen saturation, pulse rate, pulse amplitude, etc.) that will trigger an alarm, because they are considered to be dangerous levels. The alarm limit values may be encoded in memory 56 by the manufacturer or by a clinician through the oximeter monitor prior to operation).
Like Muhsin, Hebler teaches collecting and analyzing physiologic data indicative of a patient’s health, generating a risk score and displaying said risk score of each o