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 .
Claims 2-23 are pending per amendment.
Response to Arguments
103 Arguments
Applicant’s arguments with respect to claims 2-9 and 12-21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The specification does not define “medical regard system”.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 2-9 and 12-21 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 20140277227), in view of Bongberg (US 20140266718), in view of Kim (USP 7793217), in view of Olson (USP 5645571), in view of Semen (US 20150199479).
For claim 2, Peterson discloses:
A system for remotely managing a medical device, the system comprising:
a medical device that is deployed at a location, the medical device comprising:
electronics configured to deliver a therapeutic shock to a patient (par. 0122: defibrillator 410 disclosed)
a first memory (par. 0050),
a clinical component that is configured to generate clinical event information, wherein the clinical event information includes information generated while the medical device is used during a clinical event (par. 0122: defibrillator system 410 disclosed; par. 0124: “Network 1214 may also provide event patient reports and data. Any report or data transaction that occurs during a patient monitoring or therapy event may be transmitted by the defibrillator to the net server 1210. The patient event data may assist qualified medical personnel in making accurate diagnosis, disposition, and therapy decisions.”); and
one or more servers in communication with the medical device (par. 0124 & Fig. 12: net server 1210 communicates with defibrillator 410), the one or more servers comprising:
a second memory (Fig 12, netserver 1210),
a server communication component configured to receive, from the medical device, via the network connection, the clinical event information (par. 0124 & Fig. 0122: defibrillator sends patient data to netserver 1210 via network), and
one or more processors configured to
store the clinical event information in a first database (par. 0125: “The net server may also enable reports to be generated from the data taken from the patient event and transmitted as needed after the event.”; par. 0127: “…the server event service that enables scheduled downloading of data communications from the defibrillator resides on the data processor module as a client.”),
Peterson fails to explicitly disclose “…receive, from the medical device…the device readiness information”, “store the device readiness information in a second database”.
However, in a related field, Bongberg discloses a defibrillator generating messages based on its operational status/state that are periodically sent to a central server for display on “a dashboard view”. Moreover, the central server “may automatically maintain an audit trail of defibrillators (i.e., “storage” of records in a database) to maintain regulatory compliance based on the dashboard view” (par. 0006, 0019, 0045).
It would have been obvious to one of ordinary skill before effective filing date of instant claimed invention to have introduced Bongberg’s teachings of defibrillators providing operational status updates to a central server alongside Peterson. The motivation to combine would have been to provide administrators will notification of defibrillators in an adverse state that may require a technician dispatch or other servicing (Bongberg, par. 0047 and 0048).
Peterson-Bongberg fails to explicitly disclose “cause display of a user interface configured to receive a user query for one or more of a (a) at least a portion of the clinical event information stored in the first database or (b) at least a portion of the device readiness information stored in the second database; receive, from the first database and/or the second database, query result data that is responsive to the user query, and cause the user interface to display at least a portion of the query result data”.
However, in a related field, Kim discloses a system that includes a patient and examination database 20, a patient and exam search module 21, an image display module (col. 4, ll 61-64). Furthermore, a patient and exam search module allows physicians to search for specific studies and patient records via various search queries (col 5, ll 25-50).
It would have been obvious to one of ordinary skill before effective filing date of instant claimed invention to have introduced Kim’s medical records search query teachings alongside the combination. The motivation to combine would have been to provide medical staff with desired records responsive to patient/procedure search queries (Kim, col 6, ll 17-22).
While Bongberg discloses a central server processing operational status messages periodically transmitted from deployed defibrillators (par. 0019, 0022), Peterson-Bongberg-Kim fails to explicitly disclose “at least one processor configured to (a) execute a self-test that verifies that the electronics are capable of charging and discharging sufficiently to deliver the therapeutic shock to the patient, and (b) generate device readiness information indicative of a result of the self-test; a medical device communication component configured to transmit the device readiness information via a network connection after execution of the self-test”
However, in a related field, Olson teaches a defibrillator performs weekly self-test and generates alarms/indicators as warranted. Additionally, the weekly self-test results are stored in event memory 78 and are retrieved via a communication port 22 (col. 7, ll 33-46 and col 8, ll 6-17).
It would have been obvious to one of ordinary skill before effective filing date of instant claimed invention to have introduced Olson’s teachings of defibrillator weekly self-testing and recording of defibrillator status in device memory, alongside the combination’s (Bongberg’s) teachings of defibrillator periodic status message generation and subsequent transmission to a central server The motivation to combine would have been to alert operator/monitor to identified defibrillator faults (Olson, abstract).
Peterson-Bongberg-Kim-Olson combination fails to teach “wherein the device readiness information includes a device identifier for the medical device; wherein the user query received via the user interface includes the device identifier for the medical device; wherein the query result data includes one or more of (a) records for clinical events during which the medical device was used, or (b) device readiness information records for the medical device”.
However, in a related field, Semen discloses a patient records management system 100 (par. 0260) that includes patient records 234 comprising patient information 130 (par. 0263) and HME device information 330 (par. 0263). The HME device information includes HME device identifier (par. 0265). The patent records management system also includes an online portal 242 for physician terminal 140 to access and search patient and device records (par. 0266, 0267). Lastly, system discloses HME device detecting fault conditions and logging of these incidents and subsequent upload of records (par. 0248, 0258).
It would have been obvious to one of ordinary skill before effective filing date of instant claimed invention to have introduced Semen’s teachings alongside the combination. The motivation to combine would have been to provide physicians with ability to search patient reports for data regarding usage of specifically assigned medical device for diagnosis and treatment (Semen, par. 0287).
For claim 3, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein the server communication component is configured to receive additional device readiness information that is stored on a data storage medium (Olson, col. 7, ll 33-46 and col 8, ll 6-17).
For claim 4, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein the medical device communication component is configured to transmit the device readiness information to the one or more servers via the network connection without receiving a request from the one or more servers (Bongberg, par. 0044 and 0045: Communication module 102 connects to central server on periodic basis, i.e., twice per day, to transmit operational status).
For claim 5, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein:
the first memory has stored therein a schedule; and the medical device communication component is configured to transmit the device readiness information to the one or more servers according to the schedule (Bongberg, par. 0044 and 0045: Communication module 102 connects to central server on periodic basis, i.e., twice per day, to transmit operational status; Olson, col. 7, ll 33-46 and col 8, ll 6-17).
For Claim 6, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein the medical device communication component is configured to transmit the device readiness information in response to an event (Bongberg, par. 0044: Communication module 102 sends transmissions on occurrence of “event” opening the defibrillator).
For Claim 7, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 6, wherein the event is execution of the self-test (Bongberg, par. 0044 and 0045: Communication module 102 connects to central server on periodic basis, i.e., twice per day, to transmit operational status; Olson, col. 7, ll 33-46 and col 8, ll 6-17).
For Claim 8, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein themedical device communication component provides bidirectional communication between the medical device and the one or more servers (Bongberg, par. 0049: Central server sends firmware patches to defibrillator; Bongberg, par. 0045: The defibrillator 104 may send the operational state 114 of the defibrillator 104 to the central server 100 for analysis).
For Claim 9, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein:
the medical device further comprises a battery (Peterson, par. 0053: Defibrillator battery); and
the device readiness information includes information corresponding to a remaining life of the battery (Bongberg, par. 0047: Operational status/readiness data includes low battery condition).
For Claim 12, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein the one or more processors are further configured to provide at least one of a configuration file or a software update to the medical device (Bongberg, par. 0049: Central server send firmware patches to defibrillator).
For Claim 13, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein:
the medical device further comprises a cardiopulmonary resuscitation chest compression sensor (Peterson, par. 0057: Defibrillator 300 can optionally include other components….data can be communicated from the defibrillator 300 to external devices, such as patient data, incident information, therapy attempted, CPR performance); and
the clinical event information comprises cardiopulmonary resuscitation performance data generated by the cardiopulmonary resuscitation compression chest sensor (Peterson, par. 0057).
For Claim 14, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 13.
While Peterson (see par. 0057) explicitly discloses a system that captures CPR performance, it fails to explicitly disclose “wherein the at least one processor is further configured to generate one or more of cardiopulmonary resuscitation analysis or cardiopulmonary resuscitation quality prompts from the cardiopulmonary resuscitation performance data.”
However, it would have been obvious to one of ordinary skill, apprised of the cited references and the general state of the art, to have contemplated “analyzing” CPR performance data. The motivation would have been to achieve a predictable goal of deriving medical insights, trends and diagnosis from patient data to inform further treatment.
For Claim 15, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein the query result data includes the at least a portion of the clinical event information and the at least a portion of the device readiness information (Kim col 5, ll 25-50; Peterson, par. 0121 Additionally, tablet and team display 1174 disclosed for displaying event data; Bongberg, par. 0006, 0019, 0045: a defibrillator generates messages based on its operational status/state that are periodically sent to a central server for display on “a dashboard view”).
For Claim 16, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 15, further comprising a user device located remotely from the one or more servers, wherein the one or more processors are further configured to provide the user interface to the user device (Peterson, par. 0087 external patient monitor 760 disclosed).
For Claim 17, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 16, wherein the at least a portion of the clinical event information and the at least a portion of the device readiness information are provided in a medical device dashboard (Peterson, par. 0124: “Network 1214 may also provide event patient reports and data. Any report or data transaction that occurs during a patient monitoring or therapy event may be transmitted by the defibrillator to the net server 1210; Bongberg, par. 0006, 0019, 0045)
While Peterson-Bongberg combination discloses presenting clinical event and readiness information, the combination fails to explicitly disclose that is accessible via a web-based application implemented at the user device” (emphasis added).
However, it would have been obvious to one of ordinary skill, apprised of the cited references and the general state of the art, to have contemplated a web-based application for viewing event data. The motivation would have been to provide access to device/patient metrics and events utilizing well-known methods of web-based delivery of user interface and data.
For Claim 18, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 16, wherein:
the medical device further comprises audio and/or visual equipment (Peterson, par. 0075: video, audio capture disclosed); and
the one or more servers enable the user device to remotely access the audio and/or video equipment (Peterson, par. 0095, 0096).
For Claim 19, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein the clinical event information comprises waveform data comprising one or more of electrocardiogram data, blood oxygen level data, or end tidal carbon dioxide data (Peterson, par.0091, 0092: vitals data and waveform data disclosed).
For Claim 20, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2 but fails to explicitly disclose “wherein the one or more processors are further configured to obscure personally identifiable information in the clinical event information.”
However, Examiner takes official notice that techniques for obfuscating PII in healthcare devices and processes are well-known by those of ordinary skill the art. It would, therefore, have been obvious to have incorporated such techniques a medical device or platform that handles such confidential, privileged information.
For Claim 21, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein:
the medical device is a defibrillator (Peterson, par. 0122: defibrillator system 410 disclosed).
While Peterson discloses an operator sets charge level to be applied to a patient & event patient reports generated for defibrillator use (par. 0016, 0124, 0125), the combination fails to explicitly disclose “the clinical event information comprises one or more of a number of times a the therapeutic shock was applied during the clinical event or an energy level of the applied therapeutic shock”.
However, it would have been obvious to one of ordinary skill, apprised of references’ teaching & general state of the relevant art, to have contemplated, clinical event information captured for therapeutic shock sessions including such data. The motivation would have been to provide a medical clinician with relevant data in order to acquire medical insights and further inform diagnosis and treatment.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 20140277227), in view of Bongberg (US 20140266718), in view of Kim (USP 7793217), in view of Olson (USP 5645571), in view of Semen (US 20150199479), in view of Covey (US 20050277991).
For Claim 10, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, wherein:
the medical device further comprises a patient interface component (Peterson, par. 0056: user interface 370 of defibrillator).
Peterson-Bonberg-Kim-Olson-Semen fails to teach “the device readiness information includes information corresponding to a remaining life of the patient interface component.”
However, in a related field, Covey discloses an AED testing electrodes on a predetermined schedule. AED uses visual display 38 to alert person of status of electrodes or may transmit a status message to a central station (par. 0045).
It would have been obvious to one of ordinary skill before effective filing date of instant claimed invention to have introduced Covey’s teachings alongside the combination. The motivation to combine would have been to ensure timely replacement of defibrillator electrodes to ensure they perform as designed when used (Covey, par. 0004).
For Claim 11, Peterson-Bongberg-Kim-Olson-Semen-Covey discloses:
The system of Claim 10, wherein the patient interface component is a defibrillation electrode (Covey, par. 0045: user presented with electrode status warning on defibrillator display).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Peterson (US 20140277227), in view of Bongberg (US 20140266718), in view of Kim (USP 7793217), in view of Olson (USP 5645571), in view of Semen (US 20150199479), in view of Nichol (US 20130087609).
For Claim 23, Peterson-Bongberg-Kim-Olson-Semen discloses:
The system of Claim 2, but fails to explicitly disclose “wherein: the device readiness information indicates an expiration date associated with a component of the medical device; and the displayed query result data indicates the expiration date associated with the component of the medical device.”
However, in a related field, Nichol teaches a server receiving medical device/AED status data including expiration information (par. 0055 and 0056). Furthermore, server 200 provides asset monitoring and tracking of managed medical device assets. It would have been obvious to one of ordinary skill before effective filing date of instant claimed invention to have introduced Covey’s teachings alongside the combination. The motivation to combine would have been to provide management platform for alerting user/administration about required maintenance and replacement schedule of medical device components (Nichol, par. 0056, 0057, 0072).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CLAYTON R WILLIAMS whose telephone number is (571)270-3801. The examiner can normally be reached M-F 10:00am - 6:00pm.
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/CLAYTON R WILLIAMS/Primary Examiner, Art Unit 2443
