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 the Claims
Claims 1-15 are currently pending. Claims 14-15 are added in the Claims filed on October 31, 2025.
Priority
Applicant states that this application is a continuation or divisional application of the prior-filed application. A continuation or divisional application cannot include new matter. Applicant is required to delete the benefit claim or change the relationship (continuation or divisional application) to continuation-in-part because this application contains the following matter not disclosed in the prior-filed application: Claim 1 recites “[receiving] a confirmation input not from the user identifying that the patient monitoring device is located to be associated with the patient.”
[0073] of the as-filed Specification of Application 18/189646 (“the parent application”) discloses the following:
“The caregiver 22 may simply select among those devices per process block 118 or use other entry methods to confirm the particular patient monitoring device 12, for example, using scanning of barcodes or the reading of an RFID tag and the like affixed to the patient monitoring device 12. Generally these near field techniques will be limited to operation at less than 3m and ideally less than 1m.
Hence, the parent application discloses that the patient monitoring device may be confirmed according to a location (specifically distance from the patient) of the device. However, the parent application does not disclose that the confirmation is performed by and/or received from an entity other than the user.
Additionally, Claim 1 recites “maintenance data providing a measure related to degradation of patient monitoring device operation over time,” but there is no disclosure of any sort of degradation of equipment in either the as-filed Specification of the present application or the parent application. At most, [0035] and [0082]-[0083] of the as-filed Specification discloses that the maintenance data may include measures of calibration including potential calibration errors, but the aforementioned citations do not disclose any type of degradation of the patient monitoring device.
Furthermore, the as-filed Specification does not disclose the features of “the maintenance data is passed to the electronically stored and accessed maintenance database in response to receiving the user input confirming the physiological parameters” claimed in Claim 14, and the language pertaining to the passing of the physiological parameters and an indication of whether the physiological parameters were received from the patient monitoring device or manually entered by the user to the maintenance database claimed in Claim 15.
Therefore, Claims 1-15 of the present application will be afforded the effective filing date of August 11, 2025.
Claim Objections
Claim 1 is objected to for the following informalities: Claim 1 recites a step (e) and a step (g) without reciting a step (f). This appears to be a typographical error, and in the interest of compact prosecution, Examiner will interpret step (g) as functionally step (f) in that it occurs immediately after step (e).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 15 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 15, Claim 15 recites “receive a user input confirming the physiological parameters and in response passing the physiological parameters and an indication of whether the physiological parameters were received from the patient monitoring device or manually entered by the user is passed to the electronically stored and accessed maintenance database in response to receiving the user input confirming the physiological parameters.” It is unclear whether the “is passed language” refers to another passing operation, or if this is duplicative of the already recited “is passed” language. In the interest of compact prosecution, Examiner will interpret this language as “receive a user input confirming the physiological parameters and in response passing the physiological parameters and an indication of whether the physiological parameters were received from the patient monitoring device or manually entered by the user
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 1-15 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.
Step 1
Claims 1-15 are within the four statutory categories. Claims 1-15 are drawn to a device for clinical data, which is within the four statutory categories (i.e. machine).
Prong 1 of Step 2A
Claim 1 recites: A clinical data interface device adapted for relocation among different locations by a user and comprising:
a graphic interface having an electronic display and electronic sensor responsive to user commands and adapted to output a display of data to a user and receive input of data from a user;
a data input being a wireless or wired circuit adapted to communicate electronically with an electronic patient monitoring device monitoring physiological parameters of the patient to receive physiological parameters as electronic signals from the patient monitoring device;
a wireless transceiver being an electronic circuit adapted to communicate via electronic signals with a remote electronic medical record database system (EMR) holding multiple records associated with patients and stored as digital records; and
at least one electronic processor and associated memory, the memory holding at least one non-transitory program executed by the at least one electronic processor to:
(a) receive input from a user identifying a patient monitoring device associated with the patient;
(b) receive a confirmation input not from the user identifying that the patient monitoring device is located to be associated with the patient;
(c) receive electronic signal data identifying the patient;
(d) receive wireless signals as electronic signals from the patient monitoring device providing physiological parameters of the patient and display the physiological parameters on the graphic interface;
(e) receive wireless signals as electronic signals from the patient monitoring device providing maintenance data on the patient monitoring device, the maintenance data providing a measure related to degradation of patient monitoring device operation over time;
(g) pass the maintenance data to an electronically stored and accessed maintenance database.
The underlined limitations as shown above, given the broadest reasonable interpretation, cover the abstract idea of a mental process and/or a certain method of organizing human activity because they recite a process that could be practically performed in the human mind (i.e. observations, evaluations, judgments, and/or opinions – in this case, the steps of receiving user commands and input, displaying data, monitoring physiological parameters of a patient, communicating data regarding patient records, receiving confirmation input regarding a location of a device, receiving patient identifying data, receiving physiological parameters of the patient, displaying the physiological parameters, receiving maintenance data providing a measure related to degradation of patient monitoring device operation over time, and passing the maintenance data recite observations, evaluations, and/or collecting data, analyzing it, and displaying certain results of the collection and analysis) or using a pen and paper, but for the recitation of generic computer components (i.e. the graphic interface, the data input, the electronic patient monitoring device, the electronic processor and memory, and the maintenance database), and/or managing personal behavior or relationships or interactions between people (i.e. social activities, teaching, and following rules or instructions – in this case, the steps of receiving user commands and input, displaying data, monitoring physiological parameters of a patient, communicating data regarding patient records, receiving confirmation input regarding a location of a device, receiving patient identifying data, receiving physiological parameters of the patient, displaying the physiological parameters, receiving maintenance data providing a measure related to degradation of patient monitoring device operation over time, and passing the maintenance data recite as at least following rules or instructions to monitor patient parameters and an interaction between a person and a computer), e.g. see MPEP 2106.04(a)(2). Any limitations not identified above as part of the abstract idea are deemed “additional elements,” and will be discussed in further detail below.
Dependent Claims 2-15 include other limitations, for example Claim 2 recites selecting a personality file that controls the format of the data, Claim 3 recites generating maintenance reports for clinical monitors, Claim 4 recites transmitting a warning message based on the maintenance data, Claim 5 recites predicting service requirements from the maintenance data, Claims 6-10 recite specific types of maintenance data, Claim 11 recites enabling a user to search a records database, accessing a record, confirming an association between a patient and a monitoring device, formatting physiological data, transmitting the formatted data to a database, and displaying physiological data, and Claims 12-13 recite receiving various data, recording data, and displaying a report regarding the data and the handling of the data, Claim 14 recites displaying the physiological parameters and receiving user input confirming the physiological parameters, and Claim 15 recites receiving physiological parameters from a user manually, recording whether the physiological parameters were received manually, displaying the physiological parameters, and receiving input confirming the physiological parameters, but these only serve to further narrow the abstract idea, and a claim may not preempt abstract ideas, even if the judicial exception is narrow, e.g. see MPEP 2106.04. Additionally, any limitations in dependent Claims 2-15 not addressed above are deemed additional elements to the abstract idea, and will be further addressed below. Hence dependent Claims 2-15 are nonetheless directed towards fundamentally the same abstract idea as independent Claim 1.
Prong 2 of Step 2A
Claim 1 is not integrated into a practical application because the additional elements (i.e. the non-underlined limitations above – in this case, the structural limitations of the graphic interface, the data input, the electronic patient monitoring device, the electronic processor and memory, and the maintenance database, as well as the language specifying that the data is electronic data) amount to no more than limitations which:
amount to mere instructions to apply an exception – for example, the recitation of the structural limitations of the graphic interface, the data input, the electronic patient monitoring device, the electronic processor and memory, and the maintenance database, which amounts to merely invoking a computer as a tool to perform the abstract idea, e.g. see paragraphs [0049] and [0056]-[0059] of the present Specification, see MPEP 2106.05(f); and/or
generally link the abstract idea to a particular technological environment or field of use – for example, the claim language dictating that the database be a medical records database holding records of multiple patients, and the claim language specifying that the data be electronic data, which amounts to limiting the abstract idea to the field of digital healthcare, see MPEP 2106.05(h).
Additionally, dependent Claims 2-15 include other limitations, but these limitations do not include any additional elements beyond those already recited in independent Claim 1, and hence also do not integrate the aforementioned abstract idea into a practical application.
Step 2B
Claim 1 does not include additional elements that are sufficient to amount to “significantly more” than the judicial exception because the additional elements (i.e. the non-underlined limitations above – in this case the structural limitations of the portable unit, the graphic interface, electronic display, electronic sensor, the graphic interface, the data input, the patient monitoring device, the wireless transceiver, the remote electronic medical record database system, and the electronic processor and memory configured to display physiological parameters), as stated above, are directed towards no more than limitations that amount to mere instructions to apply the exception, and/or generally link the abstract idea to a particular technological environment or field of use, wherein the additional elements comprise limitations which:
amount to elements that have been recognized as well-understood, routine, and conventional activity in particular fields, as demonstrated by:
The present Specification expressly disclosing that the structural additional elements are well-understood, routine, and conventional in nature:
[0049] and [0056]-[0059] of the as-filed Specification discloses that the additional elements (i.e. the structural limitations of the graphic interface, the data input, the electronic patient monitoring device, the electronic processor and memory, and the maintenance database) comprise a plurality of different types of generic computing systems;
Relevant court decisions: The following are examples of court decisions demonstrating well-understood, routine and conventional activities, e.g. see MPEP 2106.05(d)(II):
Receiving or transmitting data over a network, e.g. see Intellectual Ventures v. Symantec – similarly, the current invention receives and responds to user commands, receives and communicates with a remote electronic medical record database system via a wireless transceiver over a network;
Electronic recordkeeping, e.g. see Alice Corp v. CLS Bank – similarly, the current invention merely recites the storing of patient medical records in a remote electronic medical record database system;
Dependent Claims 2-15 include other limitations, but none of these limitations are deemed significantly more than the abstract idea because, as stated above, the aforementioned dependent claims do not recite any additional elements not already recited in independent Claim 1, and hence do not amount to “significantly more” than the abstract idea.
Hence, Claims 1-15 do not include any additional elements that amount to “significantly more” than the judicial exception.
Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning 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 1-15 are nonetheless 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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Maus (2003/0211007) in view of Bergstrom (US 2010/0069730), further in view of Vanslyke (US 2014/0278189), and Collins (US 2009/0112630).
Regarding Claim 1, Maus teaches the following: A clinical data interface device adapted for relocation among different locations by a user (The system includes a computer station, wherein the computer station may be embodied as a laptop, e.g. see Maus [0094] and [0153], Fig. 2.) and comprising:
a graphic interface having an electronic display and electronic sensor responsive to user commands and adapted to output a display of data to a user and receive input of data from a user (The computer station includes a screen that is capable of displaying data and receiving user input of data, e.g. see Maus [0160] and [0174].);
a data input being a wireless or wired circuit adapted to communicate electronically with an electronic patient monitoring device monitoring physiological parameters of the patient to receive physiological parameters as electronic signals from the patient monitoring device (The computer station is in communications with a health monitoring and diagnostic device (i.e. an electronic patient monitoring device) that measures various patient parameters, e.g. see Maus [0076], Fig. 1, wherein the health monitoring and diagnostic device may be connected to the computer station via a removable chip inserted from the device into the computer, a wire-line data port, and/or a wireless communication device, e.g. see Maus [0090], Fig. 2.);
a wireless transceiver being an electronic circuit adapted to communicate via electronic signals with a remote electronic medical record database system (EMR) holding multiple records associated with patients and stored as digital records (The computer station is in wireless communications with a health report server (i.e. an EMR database system), e.g. see Maus [0095], wherein the health report server stores patient reports (i.e. digital records) for a plurality of patients, e.g. see Maus [0093], [0095], and [0098].); and
at least one electronic processor and associated memory (The computer station is a computer (i.e. a computer is understood to include at least a processor) that includes an installed (i.e. on a memory) software module, e.g. see Maus [0153] and [0155].), the memory holding at least one non-transitory program executed by the at least one electronic processor to:
(a) receive input from a user identifying a patient monitoring device associated with the patient (The system includes a health monitoring diagnostic device meter, e.g. see Maus [0076], wherein the meter includes a serial number (i.e. identifying data) that is saved onto a smartcard, wherein the smartcard is then loaded into a computer station and the serial number is read, e.g. see Maus [0109] and [0130].);
(c) receive electronic signal data identifying the patient (The health monitoring and diagnostic device obtains patient medical data including patient identification information, e.g. see Maus [0094], and passes this information to the computer station, e.g. see Maus [0094]-[0095].);
(d) receive wireless signals as electronic signals from the patient monitoring device providing physiological parameters of the patient and display the physiological parameters on the graphic interface (The health monitoring and diagnostic device may wirelessly transmit and display patient medical data on the computer station, e.g. see Maus [0090] and [0094]-[0095].);
But Maus does not teach and Bergstrom teaches the following: wherein the at least one electronic processor is further configured to
(e) receive wireless signals as electronic signals from the patient monitoring device providing maintenance data on the patient monitoring device (The patient monitoring device may wirelessly transmit calibration data (i.e. maintenance data) to the portable device, e.g. see Bergstrom [0069]-[0071], [0077], and [0099].); and
(g) pass the maintenance data to an electronically stored and accessed maintenance database (The patient monitoring device calibration data (i.e. the maintenance data) is transmitted to the repository (i.e. a maintenance database), e.g. see Bergstrom [0069]-[0071], [0077], and [0099].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of patient monitoring to modify Maus to incorporate the device identifying and calibration data as taught by Bergstrom in order to enable stakeholders to determine how the monitoring device has been used and the accuracy of the patient data, e.g. see Bergstrom [0099], [0102], and [0108].
Additionally, the combination of Maus and Bergstrom does not teach but Vanslyke teaches the following:
the maintenance data providing a measure related to degradation of patient monitoring device operation over time (The system includes a sensor (i.e. a clinical monitor), wherein the sensor may show signs of use and/or wear such that the accuracy of the sensor may change or drift as a function of time, and wherein the calibration of the sensor may become less accurate as the life of the sensor progresses, e.g. see Vanslyke [0008], [0096], and [0178]-[0179]. That is, the calibration data of the sensor is indicative of the accuracy of the sensor (i.e. the degradation of the clinical monitor over time).).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of patient monitoring to modify the combination of Maus and Bergstrom to incorporate tracking calibration data, wherein the calibration data is indicative of degradation of the sensor over time as taught by Vanslyke in order to ensure that the sensor obtains data that is of high levels of accuracy, e.g. see Vanslyke [0066].
Furthermore, the combination of Maus, Bergstrom, and Vanslyke does not teach but Collins teaches the following:
(b) receive a confirmation input not from the user identifying that the patient monitoring device is located to be associated with the patient (The system includes a plurality of caregivers (i.e. any of which may be interpreted as “the user” and “not the user”), e.g. see Collins [0005], wherein the system may use distance data (i.e. location) as a basis for determining whether a device should be associated with a patient and collect patient data, and may further prompt a caregiver to provide confirmation of the association, e.g. see Collins [0023], [0030], and [0134].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of healthcare to modify the combination of Maus, Bergstrom, and Vanslyke to incorporate the confirmation of the association of the device with the patient based on the location of the device as taught by Collins in order to ensure that the device is operating properly and that the patient is properly hooked up to the device, e.g. see Collins [0115].
Regarding Claim 10, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, and Maus further teaches the following:
The clinical data interface device of claim 1 wherein the maintenance data identifies a serial number of the clinical data interface (The system stores a record of the serial number for the health monitoring and diagnostic device, wherein the health monitoring and diagnostic device data may subsequently be transmitted to the computer station and the health report server, e.g. see Maus [0129]-[0131] and [0135]-[0136].).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maus, Bergstrom, Vanslyke, and Collins in view of Dubois (US 2016/0179849).
Regarding Claim 2, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, but does not teach and Dubois teaches the following:
The clinical data interface device of claim 1 wherein the at least one non-transitory program further uses an identification of the patient monitoring device to select a personality file for that monitor interpreting maintenance data into a common format for storage in the maintenance database (The system includes a schema repository that stores a plurality of schema (i.e. personality files), e.g. see Dubois [0017], wherein system identifies a schema based on one or more criteria including a device associated with received data, and wherein the schema is utilized in order to convert received data into a common data format for storage in common format data storage, e.g. see Dubois [0078].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of patient monitoring to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate selecting a particular schema to convert the data into a common format as taught by Dubois in order to enable subsequent processing, for example statistical analysis in a particular field of use, of the initially disparate types of data, e.g. see Dubois [0018] and [0027].
Claims 3-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maus, Bergstrom, Vanslyke, and Collins in view of Sehgal (US 2014/0266713).
Regarding Claim 3, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, but does not teach and Sehgal teaches the following:
The clinical data interface device of claim 1 wherein the at least one non-transitory program further operates to generate reports indicating at least one of required scheduled maintenance based on the maintenance database and a need for calibration of particular patient monitoring devices using data of the maintenance database (The system includes one or more data storage systems (i.e. a maintenance database) that store medical device data including an alert log for the medical devices, e.g. see Sehgal [0032] and [0049], wherein the stored alert log may be used to determine a frequency for which maintenance is required for a medical device, and wherein the system may subsequently generate analytics (i.e. a report) for viewing by healthcare provider to inform the healthcare provider about the performance of devices and plan their equipment inventory, e.g. see Sehgal [0050].).
Therefore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of patient monitoring to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate utilizing the maintenance database to generate analytics as taught by Sehgal in order to inform the healthcare provider about the performance of devices and plan their equipment inventory, e.g. see Sehgal [0050].
Regarding Claim 4, the combination of Maus, Bergstrom, Vanslyke, Collins, and Sehgal teaches the limitations of Claim 3, and Sehgal further teaches the following:
The clinical data interface device of claim 3 wherein the at least one non-transitory program further operates to transmit an automatic warning message triggered by a service limit and the maintenance data (The system generates analytics and alerts (i.e. any of which may be interpreted as “an automatic warning message”) based on the usage data of the device, e.g. see Sehgal [0042]-[0050].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of patient monitoring to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate the analytics and alerts as taught by Sehgal in order to inform the healthcare provider about the performance of devices and plan their equipment inventory, e.g. see Sehgal [0050].
Regarding Claim 5, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, but does not teach and Sehgal teaches the following:
The clinical data interface device of claim 1 wherein the at least one non-transitory program further operates to predict service requirements from the maintenance data (The system determines that an alert should be generated based on comparing usage data for a medical device to a maintenance threshold, wherein the alert may be issued before a specific maintenance threshold is reached, e.g. see Sehgal [0042]-[0050] – that is, the system predicts that the device should be maintained soon and/or an estimate for when maintenance will be required.).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of patient monitoring to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate generating the maintenance prediction as taught by Sehgal in order to inform the healthcare provider about the performance of devices and plan their equipment inventory, e.g. see Sehgal [0050].
Regarding Claim 8, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, but does not teach and Seghal teaches the following:
The clinical data interface device of claim 1 wherein the maintenance data is selected from the group consisting of total operating hours and total operating cycles (The system collects data for a device, wherein the data includes hours of use for the device, wherein the hours of usage for the device are compared to a threshold in order to determine whether or not the device requires maintenance and/or how much time remains for the lifespan of the device, e.g. see Seghal [0039], [0044], and [0051]-[0055].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of equipment maintenance to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate tracking the operating hours of the device as taught by Seghal in order to determine whether or not the device requires maintenance and/or how much time remains for the lifespan of the device, e.g. see Seghal [0039] and [0044].
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maus, Bergstrom, Vanslyke, and Collins in view of Woods (US 2003/0177380).
Regarding Claim 6, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, but does not teach and Woods teaches the following: The clinical data interface device of claim 1 wherein the at least one non-transitory program further operates to:
receive data identifying an individual performing maintenance (The system receives calibration data for an external apparatus, wherein the calibration data includes an identification of the operator who performed the calibration (i.e. maintenance), e.g. see Woods [0088].); and
wherein the maintenance data includes the data identifying the individual performing the maintenance and a date of the performed maintenance by the individual (The calibration data further includes a date and/or time of calibration (i.e. maintenance), as well as an identification of the operator who performed the calibration, e.g. see Woods [0088].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of equipment maintenance to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate tracking the calibration data as taught by Woods in order to enable the evaluation of the performance of equipment, such as for quality control purposes, e.g. see Woods [0006] and [0042].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maus, Bergstrom, Vanslyke, and Collins in view of Zivelin (US 2014/0278713).
Regarding Claim 7, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, but does not teach and Zivelin teaches the following:
The clinical data interface device of claim 1 wherein the at least one non-transitory program further operates to collect service information from multiple portable units to identify trending of calibration issues based on the collected service information (The system collects data for a plurality of assets (i.e. multiple portable units), wherein the data includes patterns (i.e. trends) pertinent to maintenance events (i.e. calibration issues), the pattern data used to train a predictor that predicts various likelihoods pertaining to the maintenance of assets such as a chance that a particular type of event happens, e.g. see Zivelin [0094] and [0102].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of equipment maintenance to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate tracking the patterns of maintenance data as taught by Zivelin in order to accurately forecast needs for assets, e.g. see Zivelin [0007] and [0094].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maus, Bergstrom, Vanslyke, and Collins in view of Lamego (US 2015/0073241).
Regarding Claim 9, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, but does not teach and Lamego teaches the following:
The clinical data interface device of claim 1 wherein the maintenance data includes program error codes (The system includes a medical device, a host computing device in direct communication with the medical device, and a device management system, wherein the medical device may send data to the device management system via the host computing device e.g. see Lamego [0025], Fig. 1. Additionally, the data sent from the medical device to the device management system may include calibration data including error codes, e.g. see Lamego [0060].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of equipment maintenance to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate the error codes as taught by Lamego in order to ensure accuracy of the medical device, e.g. see Lamego [0039] and [0063].
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Maus, Bergstrom, Vanslyke, and Collins in view of Dubois, further in view of McDonald (US 2004/0153443).
Regarding Claim 11, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1, and Maus further teaches the following: The clinical data interface device of claim 1 wherein the at least one non-transitory program further operates to:
receive the data identifying the patient from the accessed record of the electronic medical record database related to the patient (The health monitoring and diagnostic device obtains patient medical data including patient identification information, e.g. see Maus [0094], and passes this information to the computer station, e.g. see Maus [0094]-[0095].); and
display the physiological parameters on the graphic interface (The health monitoring and diagnostic device may wirelessly transmit and display patient medical data on the computer station, e.g. see Maus [0090] and [0094]-[0095].).
But the combination of Maus, Bergstrom, Vanslyke, and Collins does not teach and Dubois teaches the following:
identify a personality file from among multiple personality files according to the physically associated patient monitoring device (The system includes a schema repository that stores a plurality of schema (i.e. personality files), e.g. see Dubois [0017], wherein system identifies a schema based on one or more criteria including a device associated with received data, and wherein the schema is utilized in order to convert received data into a common data format for storage in common format data storage, e.g. see Dubois [0078].);
receive physiological parameters having a first electronic communication format (The data received may be in a first format and converted into a common format via the selected schema, e.g. see Dubois [0078].); and
use the identified personality file to determine that the physiological parameters should be formatted to a second electronic communication format (The system utilizes the selected schema to convert the data to a common data format, e.g. see Dubois [0078].);
format the physiological parameters to the second electronic communication format (The system utilizes the selected schema to convert the data to a common data format, e.g. see Dubois [0078].);
transmit the physiological parameters to the accessed record of the electronic medical record database in the second electronic communication format through the wireless transceiver (The data that has been formatted into the common data format is transmitted to common format data storage, e.g. see Dubois [0078].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of patient monitoring to modify the combination of Maus, Bergstrom, Vanslyke, and Collins to incorporate selecting a particular schema to convert the data into a common format as taught by Dubois in order to enable subsequent processing, for example statistical analysis in a particular field of use, of the initially disparate types of data, e.g. see Dubois [0018] and [0027].
But the combination of Maus, Bergstrom, Vanslyke, Collins, and Dubois does not teach and McDonald teaches the following:
present the user with an EMR search screen for accessing a record of the remote electronic medical record database system associated with a patient at the patient location (The system includes a database that stores a plurality of patient records containing data obtained from a plurality of patient monitoring devices, e.g. see McDonald [0017]-[0019] and [0022]-[0024], Figs. 1 and 2A. Additionally, the system enables a client computer to perform a search of the patient records via a search engine, e.g. see McDonald [0032]-[0035].);
provide the user with access to the record of the remote electronic medical record database system (The system retrieves and outputs (i.e. provides access to) the data from the patient records responsive to the search, e.g. see McDonald [0032]-[0035].).
Furthermore, before the effective filing date, it would have been obvious to one ordinarily skilled in the art of equipment maintenance to modify the combination of Maus, Bergstrom, Vanslyke, Collins, and Dubois to incorporate the EMR search function as taught by McDonald in order to enable users to more effectively handle future situations by facilitating learning and searching through patient records, e.g. see McDonald [0022], [0029], and [0037].
Regarding Claim 12, the combination of Maus, Bergstrom, Vanslyke, Collins, Dubois, and McDonald teaches the limitations of Claim 11, and Maus further teaches the following: The clinical data interface device of claim 11 wherein the at least one non-transitory program further operates to:
receive data identifying the user (The system receives identifying information for a physician and/or a patient, e.g. see Maus [0177]-[0178] and [0181]-[0182].); and
display a report indicating usage of the clinical data interface according to particular users (The user interface generates a report that includes data from the data fields that were automatically filled in (i.e. parameters received in an electronic communication) as well as fields that received manual input of data, e.g. see Maus [0183]-[0186], Figs. 26-29.).
Regarding Claim 13, the combination of Maus, Bergstrom, Vanslyke, Collins, Dubois, and McDonald teaches the limitations of Claim 11, and Maus further teaches the following: The clinical data interface device of claim 11 wherein the at least one non-transitory program further operates to:
receive data identifying the user (The system receives identifying information for a physician and/or a patient, e.g. see Maus [0177]-[0178] and [0181]-[0182].);
receive physiological parameters via a manual input (The system may receive patient physiological data, for example test results, manually, e.g. see Maus [0140] and [0183].).
record whether physiological parameters are received from the patient monitoring device or manually entered by the user (The system constructs (i.e. records) a user interface that includes patient data manually entered by a user and patient data automatically filled in with data from the health monitoring and diagnostic device, e.g. see Maus [0183].); and
display a report indicating usage of the clinical data interface according to particular users indicating relative amounts of physiological parameters received in an electronic communication and received via the manual input (The user interface generates a report that includes data from the data fields that were automatically filled in (i.e. parameters received in an electronic communication) as well as fields that received manual input of data, e.g. see Maus [0183]-[0186], Figs. 26-29.).
Subject Matter Free From Prior Art
Claims 14-15 are not presently rejected under 35 U.S.C. 102, or 103, and hence would be in condition for allowance if amended to overcome the rejections presented under 35 U.S.C. 101. The following represents Examiner’s characterization of the most relevant prior art references and the differences between the present claim language and the prior art references in view of 35 U.S.C. 102 and/or 103:
With regards to 35 U.S.C. 102 and/or 103, the following represents the closest prior art to the claimed invention, as well as the differences between the prior art and the limitations of the presently claimed invention.
Maus (US 2003/0211007) teaches a patient monitoring device in communications with a plurality of other computing devices, wherein the patient monitoring device obtains various patient physiological data including cholesterol data.
Bergstrom (US 2010/0069730) teaches tracking calibration data for patient devices including blood glucose meters, wherein the calibration data may be wirelessly sent to a database.
Vanslyke (US 2014/0278189) teaches that calibration data may be indicative of wear and tear and/or sensitivity to analyte concentration in the form of reduced accuracy as the life of a sensor progresses.
Collins (US 2009/0112630) teaches receiving a confirmation from a physician, wherein the confirmation confirms that a device should be associated with a patient, and wherein the confirmation is based on a location of the device.
Additionally, for the reasons disclosed above, the combination of Maus, Bergstrom, Vanslyke, and Collins teaches the limitations of Claim 1. However, none of the aforementioned references teach passing the maintenance data to the maintenance database in response to receiving the user input confirming the physiological parameters, as is claimed in Claim 14. Additionally, none of the aforementioned references teaches passing the physiological parameters and an indication of whether the physiological parameters were received from the patient monitoring device or manually entered to the maintenance database in response to receiving the user input confirming the physiological parameter, as is claimed in Claim 15.
The aforementioned references are understood to be the closest prior art. Various aspects of the claimed invention are known individually, but for the reasons disclosed above, the particular manner in which the elements of the present invention are claimed, when considered as an ordered combination, distinguishes from the aforementioned references and hence the invention recited in Claims 14-15 is not considered to be disclosed by and/or obvious in view of the inventions of the closest prior art references.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
Myers (US 2008/0046292) – teaches a system that receives an approval signal from a health care provider for health care data, and then forwarding the health care data to a central storage system only after it has received the approval.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN P GO whose telephone number is (703)756-1965. The examiner can normally be reached Monday-Friday 9am-6pm Pacific.
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/JOHN P GO/Primary Examiner, Art Unit 3681
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