PROSECUTION IS HEREBY REOPENED
A technology Center Director has approved of reopening prosecution by signing below.
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 .
DETAILED ACTION
This action is in response to the board decision mailed 6/26/2025 entering a new grounds of rejection for claims 1,13 and 14, see p. 7 of decision mailed 6/26/2025, and leaving patentability determination of claims 2-12 to the examiner, see p. 9-10 of decision mailed 6/26/2025. Claims 1-14 are currently pending and under examination.
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 1, 6-11 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0135588 to Al-Ali et al. (Ali) in view of US 2001/0031071 to Nichols et al. (Nichols), US 2008/0140160 to Goetz et al. (Goetz) and US 2011/0169644 to Muhsin et al. (Muhsin) (all previously cited).
In reference to at least claims 1 and 13-14
Ali teaches a medical monitoring system which discloses a patient monitoring system (e.g. Figs. 1-2) comprising: a patient monitoring device comprising a measuring unit and at least one sensor configured to monitor a patient (e.g. patient monitoring devices, 110, include a measuring unit and at least one sensor 102, para. [0074]-[0076]) , thereby generating patient monitoring data (e.g. patient monitoring devices, 110, include one or more sensors to monitor physiological data, para. [0074]-[0076]), an output device comprising mobile device which is separated from the patient monitoring device (e.g. clinical token may be a cell phone, notebook computer, PDA device, headset, etc., para. [0221]) and configured to provide a user control interface to the user (e.g. clinical token may be a cell phone, notebook computer, PDA device, headset, etc., para. [0221]) which is configured to allow the user to control the patient monitoring device (e.g. clinical token may be a cell phone, notebook computer, PDA device, headset, etc., para. [0221], input module to control patient monitoring device, para. [0220], [0224]-[0226]). Ali discloses a non-transitory computer readable medium having stored thereon instructions that when executed by a processor cause the processor to carry out a patient monitoring method as disclosed above (e.g. embodiments disclosed herein may be implemented as electronic hardware, computer software or combinations of both, para. [0448]; steps of a method or algorithm described in connection with the embodiments…can be embodied directly in hardware, in a software module executed by a processor or in combination of the two, para. [0451]-[0452]).
Ali further discloses that particular features can be enabled and disable based upon detection of the clinical token (e.g. can enable or disable particular features based upon detection of clinical token and the particular clinician present, authorize some actions or features that are typically restricted absent the presence of a clinician, para. [0241], [0249]-[0252], modify interface based on particular clinician, para. [0255]-[0256]) and allowing the user to interact with the patient monitoring device using an input module, i.e. interface, (e.g. input module to control patient monitoring device, para. [0220], [0224]-[0226]) and that the clinical token may include a communication module similar to the patient monitoring device having the ability to initiate communication with the patient monitoring device (e.g. para. [0217]-[0218], [0234]).
However, Ali does not explicitly teach the output device, i.e. clinical token, providing a user-specific control interface to the user, which is configured to allow the user to control the patient monitoring device, in accordance with provided user-specific control rules, wherein the provided user-specific control rules comprise an identification of which of a plurality of settings of the patient monitoring device that are modifiable by the user and provides the user-specific control interface including the settings of the patient monitoring device that are identified as being modifiable by the user to the user for controlling the patient monitoring device in accordance with the provided user-specific control rules or the output device comprising a detector with a detection region configured to detect an identity indication of the patient monitoring device indicative of the identity of the patient monitoring device, if the identity indication is within the detection region, wherein the output device provides the identity indication so that the user can select the patient monitoring device to control.
Nichols teaches user authentication in a medical device system which discloses an instrument or programming unit such as a portable computer (e.g. 20, Figs. 1-3) that interacts with a medical device such as an implanted device (e.g. Figs. 1-3). The programming unit includes a user-specific control interface, which is configured to allow the user to control the medical device, in accordance with provided user-specific control rules (e.g. user identification and authorization to determine type of access and level under the authorization scheme for the specific user, para. [0028], [0030]), wherein the provided user-specific control rules comprise an identification of which of a plurality of settings of the medical device that are modifiable by the user (e.g. access granted based on authorization level to access specific tools and features of the programmer, IMD or ETP, para. [0028], [0030]) and provides the user-specific control interface including the settings of the medical device that are identified as being modifiable by the user to the user for controlling the medical device in accordance with the provided user-specific control rules (e.g. access granted based on authorization level to access specific tools and features of the programmer, IMD or ETP, para. [0028], [0030]).
Goetz teaches intelligent discovery of a medical device by a programming system which discloses a patient monitoring system (e.g. 2, Fig. 1) that includes a patient monitoring device(s) configured to monitor a patient, thereby generating patient monitoring data (e.g. telemetry devices 6, IMD 8) and providing an identity indication (e.g. discovery/detect medical devices with which the programming system can communicate, para. [0044]-[0049]) and an output device (e.g. programming system(s) 4, Figs. 1-2) comprising a mobile device which is separated from the patient monitoring device (e.g. programming system may include personal computer, laptop computers, handheld computers etc., para. [0016]), the output device comprising a detector with a detection region configured to detect an identity indication of the patient monitoring device if the identity indication is within the detection region (e.g. discovery/detect medical devices with which the programming system can communicate, para. [0044]-[0049]) wherein the output device provides the identity indication so that the user can select the patient monitoring device to control (e.g. programming system may interact with user interface to select one of the discovered devices, para. [0060], [0066], [0072], programming system uses the device interaction applications to interact with selected medical device, para. [0040], [0072]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Ali to include providing within the output device, i.e. clinical token device, a user-specific control interface which is configured to allow the user to control the patient monitoring device, in accordance with provided user-specific control rules, wherein the provided user-specific control rules comprise an identification of which of a plurality of settings of the patient monitoring device that are modifiable by the user and provides the user-specific control interface including the settings of the patient monitoring device that are identified as being modifiable by the user for controlling the patient monitoring device in accordance with the provided user-specific control rules, as taught by Nichols, in order to yield the predictable result of providing layered and hierarchal access that reducing tampering, manipulation and error and provides patients with a high level of security to maintain medical data privacy.
As for providing an identity indication of the patient monitoring device indicative of the identity of the patient monitoring device, as stated within the decision (see p. 7 of decision mailed 6/26/2025) providing such an identity indication on Al-Ali’s patient monitoring system would have been obvious to a person of ordinary skill in the art for the following reasons. First, there is no dispute that the use of barcodes to convey identification information was known at the time the claimed invention was made. Providing identification information regarding a medical device such as a patient monitor when communicating with such devices was known in the art as evidence by Muhsin (e.g. identification information is received from a patient monitor, para. [0083]). The use of a physical element, such as a barcode, as the identity indication in the modified version of Al-Ali would have been nothing more than a combination of known elements having a predictable result. “‘The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.’” Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161 (Fed. Cir. 2007) (quoting KSR, 550 U.S. 398, 416 (2007)). Second, Al-Ali explicitly discloses that WiFi-enabled RFID tags and barcodes may be usable to transmit information such as a clinician ID (para. [0219]-[0221[). Accordingly, it would have been obvious to further modify the combination of Al-Ali, Nichols, and Goetz as proposed to substitute a barcode readable by a detector for the telemetry disclosed by Goetz, based on Al-Ali’s teachings of the interchangeability of these modes of information transfer. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the device of Ali with the teachings of Goetz to include providing within the clinical token “output device” such as within the communication module of Ali a detector with a detection region configured to detect an identity indication of the patient monitoring device and providing the identity indication indicative of the identity of the device so that the user can select the patient monitoring device to control in order to yield the predictable result of providing a technique that reduces the amount of user intervention needed for communicating by automatically identifying patient monitoring device(s) within range of the output device.
In reference to at least claim 6
Ali modified by Nichols and Goetz discloses wherein the output device and the patient monitoring device are configured to establish a data connection by using at least one of visible light communication (VLC) and near field communication (NFC) (e.g. ‘588, near field communication, para. [0201]).
In reference to at least claim 7
Ali modified by Nichols and Goetz discloses wherein the output device and the patient monitoring device are configured to establish a two-way data connection (e.g. ‘588, communication modules for establishing a direct data connection between monitoring device and clinical token which may include a transmitter, a receiver or a transceiver, para. [0216]-[0218]).
In reference to at least claim 8
Ali modified by Nichols and Goetz discloses wherein the output device and the patient monitoring device are adapted to establish a data connection via a data network (e.g. ‘588, hospital wlan, hospital network, internet, network, Figs. 1,2,6, para. [0073], [0075], [0095]-[0097], [0141]).
In reference to at least claim 9
Ali modified by Nichols and Goetz discloses wherein the output device is configured to provide a user interface for allowing the user to input user specific data that identified the user (e.g. ‘588, input module, para. [0220]).
In reference to at least claim 10
Ali modified by Nichols and Goetz discloses wherein the mobile device is a tablet computer (e.g. ‘588, clinical devices such as pagers, cell phones, smart phones, PDA, laptops, tablet PCs, personal computers and the like, para. [0147]; clinical token is a cell phone, notebook computer, PDA device, headset, etc. para. [0221]).
In reference to at least claim 11
Ali modified by Nichols and Goetz discloses wherein visualization rules, which define a provision of a visualization of the patient monitoring data depending on the identification of the user (e.g. ‘588, predefined user class or customized for particular individuals or groups of individuals, para. [0201], enable and disable features based on the credentials of the detected user, para. [0249]-[0252], modify interface based on particular clinician, para. [0255]-[0256], location based rules, para. [0277]-[0279]), wherein the output device is configured to provide the visualization of the patient monitoring data in accordance with the provided visualization rules (e.g. ‘588, predefined user class or customized for particular individuals or groups of individuals, para. [0201], enable and disable features based on the credentials of the detected user, para. [0249]-[0252], modify interface based on particular clinician, para. [0255]-[0256], location based rules, para. [0277]-[0279]).
Claim 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0135588 to Al-Ali et al. (Ali) in view of US 2001/0031072 to Nichols et al. (Nichols), US 2008/0140160 to Goetz et al. (Goetz) and US 2011/0169644 to Muhsin et al. (Muhsin) as applied to claim 1 further in view of US 2016/0085922 to Sweeney (Sweeny) (previously cited).
In reference to at least claim 5
Ali modified by Nichols and Goetz as evidence by Muhsin teaches a patient monitoring system according to claim 1 but does not explicitly teach the detector is an optical detector having a field of view defining the detection region and wherein the identity indication is a visual indication.
Sweeney teaches a system and method for identifying a medical device which discloses a detection device that includes an optical recognition device (e.g. para. [0007], [0025], [0051], [0111]).
It would have obvious to one having ordinary skill in the art before the effective filing date to further modify the system of Ali modified by Nichols and Goetz with the teachings of Sweeney to include the detector being an optical detector having a field of view defining the detection region and the identity indication and the another identity indication are visual indications in order to yield the predictable result of an alternative technique for identifying devices within range for communicating data to the clinician.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0135588 to Al-Ali et al. (Ali) in view of US 2001/0031071 to Nichols et al. (Nichols), US 2008/0140160 to Goetz et al. (Goetz) and US 2011/0169644 to Muhsin et al. (Muhsin) as applied to claim 1 further in view of US 2017/0155427 to Hasan et al. (Hasan) (previously cited).
In reference to at least claim 12
Ali modified by Nichols and Goetz as evidence by Muhsin teaches the patient monitoring system as defined in claim 1 (see rejection of claim 1 above) but does not explicitly teach the output device being configured to establish a data connection by using visible light communication.
Hasan discloses wireless network transfer which discloses a way to transfer data between medical monitoring devices (e.g. abstract, para. [0002],[0006], [0019]) which discloses using visible light communication which overcomes the interference problems associated with radio-frequency RF communication technology (e.g. para. [0013], [0026],[0042]).
It would have obvious to one having ordinary skill in the art before the effective filing date of the invention to further modify the patient monitoring system of Ali modified by Nichols and Goetz with the teachings of Hasan to include the output device being configured to establish a data connection by using visible light communication in order to yield the predictable result of an improved technique for providing connection between the devices that is fast and reliable and reduces potential interference problems associated with RF communication technology.
Allowable Subject Matter
Claims 2-4 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: In view of the art that is relevant to the claimed invention the prior art does not teach or reasonably suggests a patient monitoring system that includes a patient monitoring device comprising a measuring unit and at least one sensor configured to monitor a patient, thereby generating patient monitoring data and an output device comprising a mobile device which is separated from the patient monitoring device, the output device comprising a detector with a detection region and configured to provide a user-specific control interface to the user, which is configured to allow the user to control the patient monitoring device in accordance with provided user-specific control rules, wherein the output device and the patient monitoring device are configured to establish a direct data connection and wherein the patient monitoring device comprises a display configured to show either a standby screen or the patient monitoring data, wherein the patient monitoring data is only displayed when the user is in a vicinity of the patient monitoring device, respectively in combination with the other claim elements. The closest prior art includes US 2014/0135588 to Al-Ali et al. which discloses a patient monitoring device that provides a user control interface and US 2015/0269318 to Neff which discloses showing a screen with obscured demographic data when an authorized user is not present. However, the prior art does not teach or reasonably suggest the combination of elements configured as recited within the patient monitoring system of claim 2 including a display configured to show either a standby screen or the patient monitoring data, wherein the patient monitoring data is only displayed when the user is in a vicinity of the patient monitoring device.
Conclusion
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/JENNIFER L GHAND/Examiner, Art Unit 3796
/Jennifer Pitrak McDonald/Supervisory Patent Examiner, Art Unit 3796
/JONATHAN C TEIXEIRA MOFFAT/Group Director TC 3700