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 .
Response to Amendment
This office action is in reply to Applicant’s Response dated 12/09/2025. Claims 3 and 15 are amended. Claims 21-23 are new. Claims 1-23 remain pending in the application.
Response to Arguments
In response to the Applicant’s arguments, with respect to the rejection of claims 3 and 15 under 35 U.S.C. 112(b), the rejection of claims 3 and 15 under 35 U.S.C. 112(b) has been withdrawn in view of the amendment to claims 3 and 15.
The Applicant argues (see page 10) that McCurdy fails to disclose an input interface ( of a digital communication module) configured for communicative coupling to a medical device and an output interface ( of the digital communication module) configured for communicative coupling to (i) at least one other digital communication module via a wireless proprietary network, and (ii) a clinician device via the wireless proprietary network or a direct wireless link. Instead of providing a wireless proprietary network or a direct wireless link between a digital communication module and a clinician device, McCurdy provides communications through a control server. As such, McCurdy does not contemplate providing communication directly between digital communication modules and clinician devices.
In response to the Applicant’s arguments, first the claims do not recite limitations prohibiting the use of a server. Second, the claims fail to provide limitations that explain what a wireless proprietary network is. McCurdy teaches that communication media includes wired media such as a wired network or direct-wired connection, and wireless media such as acoustic, RF, infrared and other wireless media and network, such as a private network, serves as a communications link from clinical notification management application 305 (McCurdy, see figs. 1 and 4; see paragraphs 38, 41, 44 and 57). McCurdy further teaches that an organization enters commands and information into the control server 102 or convey the commands and information to the control server 102 via one or more of the remote computers 108 through input devices and input devices comprise satellite dishes, which are wireless devices. Additionally, paragraph 0052 clarifies that smart phone and smart watch can be used which further indicates that McCurdy uses a wireless network. It is clear that McCurdy utilizes a private network (proprietary network) and wireless media and system (wireless network) including satellite dishes, smart phones and smart watches for communication. Thus, McCurdy teaches “an input interface (of a digital communication module) configured for communicative coupling to a medical device and an output interface (of the digital communication module) configured for communicative coupling to (i) at least one other digital communication module via a wireless proprietary network, and (ii) a clinician device via the wireless proprietary network or a direct wireless link”. Accordingly, McCurdy and Handler teaches all of the features of claims 1 and 13.
Allowable Subject Matter
Claims 21-23 allowed.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “data manager” in claims 1-4, 10 and 21-23; “plurality of digital communication modules” in claim 21; and “file configuration manager” in claim 23.
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation: "the DCM receives medical treatment data and/or medical event data” and “instructions…executed by a processor of the DCM” (see paragraphs 0073 and 00150 of the specification as filed).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-2, 7-11, 13-14 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy et al. (U.S. PGPub 2019/0206577) in view of Handler (U.S. PGPub 2017/0043089).
Regarding claims 1 and 13, McCurdy teaches A digital communication module comprising: an input interface configured for communicative coupling to a medical device, (McCurdy, see figs. 1 and 4; see paragraph 0057 where If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices... the notification is provided to the device; see paragraph 0044 where private network, serves as a communications link from clinical notification management application 305...; see paragraph 0038 where communication media includes... wireless media such as acoustic, RF, infrared and other wireless media; see also paragraph 0040 where local area networks (LANs) )
an output interface configured for communicative coupling to (i) at least one other digital communication module via a wireless proprietary network, and (McCurdy, see figs. 1 and 4; see paragraph 0057 where If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices... the notification is provided to the device; see paragraph 0044 where private network, serves as a communications link from clinical notification management application 305...; see paragraph 0038 where communication media includes... wireless media such as acoustic, RF, infrared and other wireless media; see also paragraph 0040 where local area networks (LANs); see also paragraphs 41 and 52)
(ii) a clinician device via the wireless proprietary network or a direct wireless link, (McCurdy, see figs. 1 and 4; see paragraph 0057 where If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices... the notification is provided to the device; see paragraph 0044 where private network, serves as a communications link from clinical notification management application 305...; see paragraph 0038 where communication media includes... wireless media such as acoustic, RF, infrared and other wireless media; see also paragraph 0040 where local area networks (LANs); see also paragraphs 41 and 52)
a memory device configured to store criteria for transmitting a notification to the clinician device; and (McCurdy, see fig. 4; see paragraph 0057 where the clinician user preferences are stored in a local database of the clinical notification management application. The user preferences can be specific to the user and to the individual(s) the user clinician is treating. At step 430, clinical data, such as test results for an individual are received and evaluated to see if they satisfy user notification preference.)
a data manager communicatively coupled to the input interface, the output interface, and the memory device, the data manager being configured to: receive medical device data from the medical device, (McCurdy, see fig. 3; see paragraph 0044 where a clinical notification system 300 includes a client server 310, such as Cerner Millennium, with active relational database files is located in a location such as a pharmacy, hospital system servers in a cloud-computing environment. Clinical notification management application 305 resides on a control server and is in communication with multiple clinician devices 315, 320 and 325 to provide notifications to the clinician according to the clinician's subscription preferences via a network (not shown). A network, such as the internet or other public or private network...)
determine at least some of the medical device data satisfies the criteria, and (McCurdy, see fig. 4; see paragraph 0057 where clinical data, such as test results for an individual are received and evaluated to see if they satisfy user notification preference…)
transmit a notification message to the clinician device via the proprietary network or the direct wireless link, (McCurdy, see fig. 4; see paragraph 0057 where If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices... the notification is provided to the device; see paragraph 0044 where private network, serves as a communications link from clinical notification management application 305...; see also paragraph 0041)
the notification message being indicative of the at least some of the medical device data satisfying the criteria. (McCurdy, see fig. 4; see paragraph 0057 where clinical data may be subsequent medical data received after the clinician user preferences are received. The clinical data could be information specific to an individual patient, a department or information related to charting patient information... If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices...)
However, McCurdy does not explicitly teach the input interface including at least one of a serial input port, an Ethernet input port, and a wireless input port;
the output interface including at least one of an Ethernet output port or a wireless output port;
at least one configuration file with a network address or identifier of the clinician device and
Handler teaches the input interface including at least one of a serial input port, an Ethernet input port, and a wireless input port; (Handler, see figs. 1 and 5; see paragraph 0038 where an infusion gateway 112, a RFT gateway 114, and a monitor gateway 116a wireless connection (e.g., an Ethernet network, LAN, WLAN, etc.)…; see paragraph 0059 where The RFT gateway 114 is configured to provide bi-directional communication with the machine 104 for the wired/wireless secure transfer...)
the output interface including at least one of an Ethernet output port or a wireless output port; (Handler, see figs. 1 and 5; see paragraph 0038 where an infusion gateway 112, a RFT gateway 114, and a monitor gateway 116a wireless connection (e.g., an Ethernet network, LAN, WLAN, etc.)…; see paragraph 0059 where The RFT gateway 114 is configured to provide bi-directional communication with the machine 104 for the wired/wireless secure transfer...)
at least one configuration file with a network address or identifier of the clinician device and (Handler, see paragraph 0074 where transmit the identifier in addition to an IP address or MAC address of the monitor 106 to the gateway...the patient identifier…; see paragraph 0097 where To receive the data...provide a patient identifier as well as a MAC address or IP address. The IP or MAC address is used by the integration engine 160 as a destination address...; see also paragraph 0125 an IP address or other address/identifier/port interface number )
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to combine McCurdy and Handler to provide the technique of the input interface including at least one of a serial input port, an Ethernet input port, and a wireless input port, the output interface including at least one of an Ethernet output port or a wireless output port and at least one configuration file with a network address or identifier of the clinician device of Handler in the system of McCurdy in order to provide compatibility and make it easier to share and integrate data (Handler, see paragraph 0004).
Regarding claims 2 and 14, McCurdy-Handler teaches wherein the data manager is further configured to: allow an authorized connection from the clinician device; (McCurdy, see fig. 4; see paragraph 0057 where clinical data may be subsequent medical data received after the clinician user preferences are received. The clinical data could be information specific to an individual patient, a department or information related to charting patient information... If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices...)
provide a template form requesting data as to which notifications are desired, including setting thresholds and/or conditions as to when the notifications are to be generated, in particular the template form requesting priorities for alarms, event or alerts; and (McCurdy, see figs. 4 and 7; see paragraph 0052 where a medical summary for an individual being treated by the clinician or order entry screen for the individual are provided to a clinician…; see paragraph 0053 where he clinical notification management application receives selection of the clinician of criteria to notify the clinician. Other information that may be selected by the user clinician includes what user device to notify. The user selectable options can include the relationship between the clinician and individual being medically treated (e.g., doctor patient relationship). The subscriptions can also be based on location of the individual...; see paragraph 0057)
use template form data to set the criteria. (McCurdy, see fig. 4; see paragraph 0052 where a medical summary for an individual being treated by the clinician or order entry screen for the individual are provided to a clinician…; see paragraph 0053 where he clinical notification management application receives selection of the clinician of criteria to notify the clinician. Other information that may be selected by the user clinician includes what user device to notify. The user selectable options can include the relationship between the clinician and individual being medically treated (e.g., doctor patient relationship). The subscriptions can also be based on location of the individual...; see paragraph 0057)
Regarding claim 7, McCurdy-Handler teaches wherein the direct wireless link is included as part of the wireless proprietary network. (McCurdy, see fig. 4; see paragraph 0057 where If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices... the notification is provided to the device; see paragraph 0044 where private network, serves as a communications link from clinical notification management application 305...; see paragraph 0038 where communication media includes... wireless media such as acoustic, RF, infrared and other wireless media)
Regarding claims 8 and 19, McCurdy-Handler teaches wherein the criteria for the notification corresponds to at least one of an alarm, an alert, or an event. (McCurdy, see fig. 4; see paragraph 0057 where clinical data may be subsequent medical data received after the clinician user preferences are received. The clinical data could be information specific to an individual patient, a department or information related to charting patient information... If step 435 is satisfied, then the control server may proceed to step 440. At step 440, the control server determines a notification route to provide the alert to the clinician selected medical devices...)
Regarding claims 9 and 20, McCurdy-Handler teaches wherein the criteria or the notification specify parameters related to a medical treatment that are to be transmitted to the clinician device. (McCurdy, see figs. 4 and 7; see paragraph 0052 where a medical summary for an individual being treated by the clinician or order entry screen for the individual are provided to a clinician…; see paragraph 0053 where he clinical notification management application receives selection of the clinician of criteria to notify the clinician. Other information that may be selected by the user clinician includes what user device to notify. The user selectable options can include the relationship between the clinician and individual being medically treated (e.g., doctor patient relationship). The subscriptions can also be based on location of the individual...; see paragraph 0057)
Regarding claim 10, McCurdy-Handler teaches wherein the data manager is further configured to receive a configuration message via the output interface, the configuration message including the at least one configuration file. (Handler, see paragraph 0074 where transmit the identifier in addition to an IP address or MAC address of the monitor 106 to the gateway...the patient identifier…; see paragraph 0097 where To receive the data...provide a patient identifier as well as a MAC address or IP address. The IP or MAC address is used by the integration engine 160 as a destination address...; see also paragraph 0125) The motivation regarding to the obviousness to claims 1 and 13 is also applied to claim 10.
Regarding claim 11, McCurdy-Handler teaches wherein the medical device data includes at least one of event information related to a treatment performed by the medical device, a log from the medical device, and treatment programming information related to the medical device. (McCurdy, see paragraphs 0015-0016 where efficiently notifying a clinician of clinical information even when a user is not logged into an individual's electronic medical record... receive notification when entering an order into an individual's electronic medical record...; see also paragraph 0053)
Claims 3-4 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy et al. (U.S. PGPub 2019/0206577) in view of Handler (U.S. PGPub 2017/0043089) further in view of Peterson et a. (U.S. PGPub 2020/0258363).
Regarding claims 3 and 15, McCurdy-Handler teaches all of the features of claims 1 and 13. However, McCurdy-Handler does not explicitly teach wherein the data manager is configured to broadcast and rebroadcast the notification message to ensure the message reaches the clinician device.
Paterson teaches wherein the data manager is configured to broadcast and rebroadcast the notification message to ensure the message reaches the clinician device. (Peterson, see paragraphs 0068 and 0069 where the message server 140 may repeatedly resend the alert/warning to the responsible personnel at every predetermined period for a period sufficiently long enough to take care of the detection...resend the alert/warning every time after a predetermined period has passed without receiving a response text message, email, or any communication from the responsible person. After receiving the response, the message server 140 may stop resending the alert/warning...)
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to combine McCurdy-Handler and Paterson to provide the technique of wherein the data manager is configured to broadcast and rebroadcast the notification messages to ensure the message reaches the clinician device of Paterson in the system of McCurdy-Handler in order to prevent hazardous effects (Peterson, see paragraph 0003).
Regarding claims 4 and 16, McCurdy-Handler-Paterson teaches wherein the data manager is configured to rebroadcast the notification message until either a maximum broadcasting time is reached, a maximum number of broadcastings has been made, or an acknowledgement message is received from the clinician device. (Peterson, see paragraphs 0068 and 0069 where the message server 140 may repeatedly resend the alert/warning to the responsible personnel at every predetermined period for a period sufficiently long enough to take care of the detection...resend the alert/warning every time after a predetermined period has passed without receiving a response text message, email, or any communication from the responsible person. After receiving the response, the message server 140 may stop resending the alert/warning...) The motivation regarding to the obviousness to claim 3 is also applied to claim 4.
Claims 5-6, 12 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over McCurdy et al. (U.S. PGPub 2019/0206577) in view of Handler (U.S. PGPub 2017/0043089) further in view of Kaipu Narahari et al. (U.S. PGPub 2020/0341529).
Regarding claims 5 and 17, McCurdy-Handler teaches all of the features of claims 1 and 13. However, McCurdy-Handler does not explicitly teach wherein the wireless proprietary network includes at least one of a Zigbee® wireless protocol, a Z-Wave® wireless protocol, a WeMo® wireless protocol, or a low-power wide-area network (“LPWAN”) wireless protocol.
Kaipu Narahari teaches wherein the wireless proprietary network includes at least one of a Zigbee® wireless protocol, a Z-Wave® wireless protocol, a WeMo® wireless protocol, or a low-power wide-area network (“LPWAN”) wireless protocol. (Kaipu Narahari, see paragraphs 0042-0043 where include one or more of the following wireless communication technologies: Bluetooth Low Energy (BLE), BLE mesh, ZigBee...including the Bluetooth 4.0 Specification and the Bluetooth 5.0…)
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to combine McCurdy-Handler and Kaipu Narahari to provide the technique of the wireless proprietary network includes at least one of a Zigbee® wireless protocol, a Z-Wave® wireless protocol, a WeMo® wireless protocol, or a low-power wide-area network (“LPWAN”) wireless protocol of Kaipu Narahari in the system of McCurdy-Handler in order to perform functions faster, more efficiently or more reliably (Kaipu Narahari, see paragraph 0003).
Regarding claims 6 and 18, McCurdy-Handler teaches all of the features of claims 1 and 13. However, McCurdy-Handler does not explicitly teach wherein the direct wireless link is provided using at least one of a Bluetooth® wireless protocol, a Bluetooth® mesh wireless protocol, or a Bluetooth® 5.0 wireless protocol.
Kaipu Narahari teaches wherein the direct wireless link is provided using at least one of a Bluetooth® wireless protocol, a Bluetooth® mesh wireless protocol, or a Bluetooth® 5.0 wireless protocol. (Kaipu Narahari, see paragraphs 0042-0043 where include one or more of the following wireless communication technologies: Bluetooth Low Energy (BLE), BLE mesh, ZigBee...including the Bluetooth 4.0 Specification and the Bluetooth 5.0…)
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to combine McCurdy-Handler and Kaipu Narahari to provide the technique of the direct wireless link is provided using at least one of a Bluetooth® wireless protocol, a Bluetooth® mesh wireless protocol, or a Bluetooth® 5.0 wireless protocol of Kaipu Narahari in the system of McCurdy-Handler in order to perform functions faster, more efficiently or more reliably (Kaipu Narahari, see paragraph 0003).
Regarding claim 12, McCurdy-Handler teaches all of the features of claims 1 and 13. However, McCurdy-Handler does not explicitly teach wherein the digital communication module is configured as an Internet of Things (“IoT”) gateway.
Kaipu Narahari teaches wherein the digital communication module is configured as an Internet of Things (“IoT”) gateway. (Kaipu Narahari, see figs. 1 and 9; see paragraph 0039 where using a wireless connection...an Internet of Things (IoT) network...using a wireless connection may serve as a gateway; see paragraph 0041 where an Internet of Things (IoT) device; see paragraph 0062 where a router 610 (also known as a gateway) may provide network connectivity between electronic devices and a network...)
It would have been obvious to one of ordinary skill in the art, at the time the invention was filed, to combine McCurdy-Handler and Kaipu Narahari to provide the technique of the digital communication module is configured as an Internet of Things (“IoT”) gateway of Kaipu Narahari in the system of McCurdy-Handler in order to perform functions faster, more efficiently or more reliably (Kaipu Narahari, see paragraph 0003).
Conclusion
THIS ACTION IS MADE FINAL. 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 MENG VANG whose telephone number is (571)270-7023. The examiner can normally be reached M-F 8AM-2PM, 3PM-5PM.
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/MENG VANG/Primary Examiner, Art Unit 2443