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 .
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed 5/06/2026 is acknowledged.
Claims 1-10 and 18-20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/06/2026.
Information Disclosure Statement
The information disclosure statements (IDS) were submitted on 1/15/2025 and 6/02/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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 14 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 14, the claim recites the limitation “operate as the faulty medical device prior to a fault” in lines 2-3. It is unclear as to how the replacement medical device is operating as the faulty medical device even prior to the faulty medical device being in a fault state. Furthermore, the language renders it unclear as to whether the “prior to a fault” should be interpreted as prior to the fault of the faulty medical device, or prior to a fault of the new replacement medical device. If the applicant intends to claim that the replacement medical device is configured with the configuration that the faulty medical device had prior to the faulty medical device entering a fault state, the language should more particularly claim this interpretation. For these reasons, the claim is rejected for indefiniteness.
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 11-15 are rejected under 35 U.S.C. 103 as being unpatentable over Falk (U.S. Pub. No. 20210297415) hereinafter Falk, in view of Amthor et al. (U.S. Pub. No. 20220310240) hereinafter Amthor.
Regarding claim 11, primary reference Falk teaches:
A method for servicing a faulty device (abstract), the method comprising:
separating a system identification module from a housing of the faulty device ([0006]-[0010], configuration module forms a system identification module on a housing of a first device; [0011]-[0012]; [0016], configuration module can be attached to a second device; [0017]-[0018], disconnecting the configuration module from the device; [0019]; [0032]-[0033], disconnection from a first device; [0034]-[0037], configuration module; [0041]-[0045], connected detachably to the first device; [0048], disconnected from a first device to provide connection to a second device; [0059], “A replacement device does not have to be configured explicitly, but rather it is sufficient to withdraw the configuration module from the defective device and to insert it into the new device”; [0070]-[0075], configuration module CM1 is switched from a first device to a second device, which forms a separating from the housing of the first device; [0079]; [0084]; see [0003], [0035], [0059] for exchange of defective devices with a replacement device);
connecting the system identification module to a housing of a replacement device ([0006]-[0010], configuration module forms a system identification module on a housing of a first device; [0011]-[0012]; [0016], configuration module can be attached to a second device for configuring the device; [0017]-[0019]; [0034]-[0037], configuration module for configuring a second device (replacement device); [0041]-[0045], connected detachably to the first device and provided with configuration specific data to an additional device; [0048], disconnected from a first device to provide connection to a second device for configuring; [0059], “A replacement device does not have to be configured explicitly, but rather it is sufficient to withdraw the configuration module from the defective device and to insert it into the new device” which enables simplified configuring; [0070]-[0075], configuration module CM1 is switched from a first device to a second device, which forms a separating from the housing of the first device; [0079]; [0084]; see [0003], [0035], [0059] for exchange of defective devices with a replacement device and use of configuration module for configuring); and
configuring the replacement device based on data from the system identification module ([0006]-[0010], configuration module forms a system identification module on a housing of a first device; [0011]-[0012]; [0016], configuration module can be attached to a second device for configuring the device; [0017]-[0019]; [0034]-[0037], configuration module for configuring a second device (replacement device); [0041]-[0045], connected detachably to the first device and provided with configuration specific data to an additional device; [0048], disconnected from a first device to provide connection to a second device for configuring; [0059], “A replacement device does not have to be configured explicitly, but rather it is sufficient to withdraw the configuration module from the defective device and to insert it into the new device” which enables simplified configuring; [0070]-[0075], configuration module CM1 is switched from a first device to a second device, which forms a separating from the housing of the first device; [0079]; [0084]; see [0003], [0035], [0059] for exchange of defective devices with a replacement device and use of configuration module for configuring).
Primary reference Falk fails to teach:
Wherein the faulty device is a faulty medical device
However, the analogous art of Amthor of a system for hospital assets logistics optimization (abstract) teaches:
Wherein the faulty device is a faulty medical device ([0062]-[0063], faulty conditions of medical devices and providing replacement items in conjunction with the broken devices; claim 12)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the faulty device system identification and replacement device configuration method of Falk to incorporate the use with faulty medical device replacement as taught by Amthor because hospitals and medical facilities often utilize personnel with little or no medical training to locate and dispatch medical devices (Amthor, [0003]). By utilizing optimized asset logistics software, higher accuracy can be obtained in positioning and operating large quantities of devices across a clinical environment, leading to reduced down-time and improved patient care.
Regarding claim 12, the combined references of Falk and Amthor teaches all of the limitations of claim 11. Primary reference Falk further teaches:
wherein separating comprises unplugging an electrical connector, and wherein connecting comprises plugging the electrical connector ([0006]-[0010], configuration module forms a system identification module on a housing of a first device; [0011]-[0012]; [0016], configuration module can be attached to a second device; [0017]-[0018], disconnecting the configuration module from the device; [0019]; [0032]-[0033], disconnection from a first device; [0034]-[0037], configuration module; [0041]-[0045], connected detachably to the first device; [0048], disconnected from a first device to provide connection to a second device; [0059], “A replacement device does not have to be configured explicitly, but rather it is sufficient to withdraw the configuration module from the defective device and to insert it into the new device”; [0060], plugged into first device forms an electrical connector for unplugging and plugging; [0070]-[0075], configuration module CM1 is switched from a first device to a second device, which forms a separating from the housing of the first device; [0079]; [0082], configuration module connected by being plugged in; [0084], unplugged and plugged in to a second device; see [0003], [0035], [0059] for exchange of defective devices with a replacement device).
Regarding claim 13, the combined references of Falk and Amthor teaches all of the limitations of claim 11. Primary reference Falk further teaches:
wherein configuring comprises connecting to a local network, configuring the replacement medical device, setting presets of the replacement medical device, and/or establishing user account access ([0013], transmission to a transmission network and credentials form a user account access for using the device; [0059], communication network for configuration; [0078], network interface; see also [0006]-[0018], module-specific credential; [0021]-[0030]; [0034]-[0039]; [0060]-[0064]; [0070]-[0075]; [0081]; [0083]-[0084]).
Regarding claim 14, the combined references of Falk and Amthor teaches all of the limitations of claim 11. Primary reference Falk further teaches:
wherein configuring the replacement medical device comprises configuring to operate as the faulty medical device prior to a fault (Configuration of a second device to the configuration of the initial first device, forms an operating as the faulty medical device prior to that device being in a fault state. See also 112(b) rejection above. [0006]-[0010], configuration module forms a system identification module on a housing of a first device; [0011]-[0012]; [0016], configuration module can be attached to a second device for configuring the device; [0017]-[0019]; [0034]-[0037], configuration module for configuring a second device (replacement device); [0041]-[0045], connected detachably to the first device and provided with configuration specific data to an additional device; [0048], disconnected from a first device to provide connection to a second device for configuring; [0059], “A replacement device does not have to be configured explicitly, but rather it is sufficient to withdraw the configuration module from the defective device and to insert it into the new device” which enables simplified configuring; [0070]-[0075], configuration module CM1 is switched from a first device to a second device, which forms a separating from the housing of the first device; [0079]; [0084]; see [0003], [0035], [0059] for exchange of defective devices with a replacement device and use of configuration module for configuring).
Regarding claim 15, the combined references of Falk and Amthor teaches all of the limitations of claim 11. Primary reference Falk further teaches:
further comprising receiving the replacement medical device prior to separating the system identification model, and shipping the faulty medical device without the system identification module after the separating (Unplugging a configuration module from a first device and then attaching to the second device, forms a receiving of the replacement device prior to detachment of the configuration module. The faulty device removed from use, forms a shipping of the device without the configuration module as only one module is utilized between two devices and remains connected to the second device after installation. [0006]-[0010], configuration module forms a system identification module on a housing of a first device; [0011]-[0012]; [0016], configuration module can be attached to a second device for configuring the device; [0017]-[0019]; [0034]-[0037], configuration module for configuring a second device (replacement device); [0041]-[0045], connected detachably to the first device and provided with configuration specific data to an additional device; [0048], disconnected from a first device to provide connection to a second device for configuring; [0059], “A replacement device does not have to be configured explicitly, but rather it is sufficient to withdraw the configuration module from the defective device and to insert it into the new device” which enables simplified configuring; [0070]-[0075], configuration module CM1 is switched from a first device to a second device, which forms a separating from the housing of the first device; [0079]; [0084]; see [0003], [0035], [0059] for exchange of defective devices with a replacement device and use of configuration module for configuring).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Falk, in view of Amthor as applied to claim 11 above, and further in view of Hartman et al. (U.S. Pub. No. 20070170239) hereinafter Hartman.
Regarding claim 16, the combined references of Falk and Amthor teaches all of the limitations of claim 11. Primary reference Falk further fails to teach:
further comprising storing patient information on the system identification module and not any memory of the faulty medical device, and wherein configuring comprises providing access to the patient information
However, the analogous art of Hartman of a portable device for storing medical information (abstract) teaches:
further comprising storing patient information on the system identification module and not any memory of the faulty medical device, and wherein configuring comprises providing access to the patient information ([0028]-[0030], portable device 210 forms a patient identification storage system that teaches towards the configuration module of primary reference Falk, as the portable device 210 also includes interoperability between devices and/or peripherals with the stored data ([0031]); [0038], patient data is stored on the flash drive; [0039], data stored on portable device 210; [0040], connected via USB port; [0043]; [0045], portable device 210 with a USB interface; [0046]-[0047]; [0050], configuration files; [0053], additional data may be stored on the device; [0058]; [0062], portable device 210; [0064]; [0073]; [0076], USB or other portable port-based device).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the faulty device system identification and replacement device configuration method of Falk and Amthor to incorporate the storing of patient information on the removeable storage device as taught by Hartman because placing data directly on a portable device from medical organization originated sources, risks associated with improper keying of data is reduced or eliminated (Hartman, [0062]). This leads to higher quality data management with electronic medical records, leading to improved clinical outcomes.
Regarding claim 17, the combined references of Falk and Amthor teaches all of the limitations of claim 11. Primary reference Falk further fails to teach:
further comprising displaying a label on the system identification module, the label identifying the faulty medical device
However, the analogous art of Hartman of a portable device for storing medical information (abstract) teaches:
further comprising displaying a label on the system identification module, the label identifying the corresponding medical device ([0038], “The scanner and bar code labeling device is configured to mark each portable device 210 shipped to ensure proper replacement in the event of loss and to update the portable device 210 either via remote application or by company based update. This device bar code numbers is configured to be includes with the patient record stored in the account database. It is noted that other unique identifiers to associate patient records with their respective portable device 210 also can be used, for example, chip etched identification numbers, secured radio frequency tags, and serial numbers.” This unique labeling system of the attachable drive would provide identification of the faulty medical device in the combined prior art invention with Falk and Amthor, in which the detachable data storage system is used in conjunction with the faulty medical device replacement as taught by Falk).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the faulty device system identification and replacement device configuration method of Falk and Amthor to incorporate the storing of patient information on the removeable storage device with a corresponding label as taught by Hartman because labeling associated portable devices provides users with direct documentation of associated portable storage systems, which reduces risks associated with improper keying of data or supplying an improper portable storage system (Hartman, [0038]; [0062]). This leads to higher quality data management with electronic medical records, leading to improved clinical outcomes.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Lo et al. (U.S. Pub. No. 20200387635) teaches to a file analysis tool that utilizes machine learning to determine medical patient data. The reference further teaches to stored medical records on a remote flash drive for access.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at 571-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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