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 I claims 15 – 23 in the reply filed on 07/12/2026 is acknowledged. Claims 24 – 27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention II, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement filed 09/20/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Specifically, there is no copy of CN 104225770 (only a translation is included).
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 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 15 – 17 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104225770 (Pan) (of record) (references are given according to English translation) in view of US 20110092958 (Jacobs).
Regarding claim 15, Pan teaches “A method for monitoring a plurality of negative pressure wound therapy devices via a wireless network (Shown in FIG 4 and described in par. 0042: the control center 100 is a mobile communication terminal (shown as a smartphone in FIG 4) connected to the first negative pressure therapy device 200 and the second negative pressure therapy device 300 (representing “a plurality of negative pressure wound therapy devices”) through a wireless network, specifically through infrared, Bluetooth, WiFi, the Internet or a telecommunication network to achieve data communication), the method comprising:
receiving, via a wireless radio, information regarding the plurality of negative pressure wound therapy devices (paragraph 0055: the first negative pressure therapy device 200 and the second negative pressure therapy device 200 [read 300] send therapy data to the control center 100 [in the embodiment of FIG 4, the control center 100 is a mobile communication terminal] when receiving the acquisition instruction sent by the control center 100, or at a preset time. Wherein, the treatment data includes one or more of the following parameters: the negative pressure provided by the negative pressure therapy device in each period, the volume of wound exudate pumped by the negative pressure therapy device, and the wound exudate pumped by the negative pressure therapy device, the change curve of the volume and time of the exudate and the color and/or transparency of the volume of the wound exudate pumped by the negative pressure therapy device.); and
displaying, via a user interface (presence of user interface and display is inherent in the smartphone shown in FIG 4)…”
“…wherein the information regarding the plurality of negative pressure wound therapy devices comprises at least one of:
an operational status of each of the plurality of negative pressure wound therapy devices (paragraph 0055: the first negative pressure therapy device 200 and the second negative pressure therapy device 200 [read 300] send therapy data to the control center 100 when receiving the acquisition instruction sent by the control center 100. Wherein, the treatment data includes: the negative pressure provided in each period, the volume of wound exudate pumped by the device, the change curve of the volume and time of the exudate and the color and/or transparency of the volume of the wound exudate pumped by the device, all representing broadly claimed “an operational status of each of the plurality of negative pressure wound therapy devices”.);
a remaining energy level of an energy storage device of each of the plurality of negative pressure wound therapy devices;
an alert regarding at least one of a low remaining energy level of the energy storage device and a malfunction of each of the plurality of negative pressure wound therapy devices;
a device identification value of each of the plurality of negative pressure wound therapy devices (paragraphs 0047 – 0048: after the control center 100 sends the communication request information to the negative pressure therapy devices 200 and 300, the negative pressure therapy devices 200 and 300 verify the received communication request information, and return confirmation information to the control center 100 after the verification is successful. The confirmation information returned by the negative pressure therapy devices 200 and 300 carry respective serial number information (“a device identification value”).);
a log of operational information of each of the plurality of negative pressure wound therapy devices over a previous time period (paragraph 0055 describing various information transmitted to the control center 100 by the devices 200 and 300. For example, transmission of the negative pressure provided in each period represents “a log of operational information”); and
a signal strength between a second wireless network and each of the plurality of negative pressure wound therapy devices (Since the claim is written in the alternative form (“at least one of A, B, C, D, E and F”), it is sufficient to meet at least one of the limitations “A” or “B” or “C” or “D” or “E” or “F”. In this case the limitations “A”, “D” and “E” are met.).”
Pan does not disclose that “the information regarding the plurality of negative pressure wound therapy devices” is displayed via the user interface.
In similar art, Jacobs also teaches apparatus and method of using negative pressure therapy to treat a wound (see paragraph 0001). Paragraph 0026: FIG. 2 illustrates the wound treatment apparatus 10 coupled to a communication network 34. The controller 14 of wound treatment apparatus 10 can send data and receive data from a caregiver's computer 36. Paragraph 0027: data such as oxygen saturation level from sensor 26, pH level from sensor 28, temperature from temperature sensor 29, carbon dioxide data from sensor 30, wound images from 3-D camera 32, or other data may be sent to a caregiver's computer 36 at remote a location (corresponding to Pan’s control center 100 being a mobile communication terminal). The caregiver may then review the data related to the particular wound being treated and adjust the therapy from the remote caregiver's computer 36. This means that there must be a user interface capable of “displaying, via a user interface, the information regarding the … negative pressure wound therapy device” to the user.
Therefore, it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application to utilize disclosed by Jacobs transmission of operational information for subsequent presentation to the caregiver at a remote location, in the system of Pan, and also apply this capability to Pan’s plurality of negative pressure wound therapy devices. Doing so would have allowed the user (e.g. caregiver, nurse, etc.) of Pan’s control center 100, such as a smartphone, to have most up-to-date information transmitted from other devices connected within the network so that the therapy may be monitored and/or adjusted from the remote location as needed.
While listing various parameters to be sent to the caregiver’s computer in paragraph 0027, Jacobs does not seem to limit the parameters to only those explicitly disclosed by stating that other data may be sent to caregiver as well. Therefore, it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application to allow displaying of all other information collected from the plurality of negative pressure wound therapy devices, including the information recited by the claim simply as design choice with predictable results having no patentable significance.
Regarding claim 16, Pan teaches “further comprising exporting the information regarding the plurality of negative pressure wound therapy devices to an external device (paragraph 0055: the first negative pressure therapy device 200 and the second negative pressure therapy device 200 [read 300] send therapy data to the control center 100, which is, in the embodiment of FIG 4, a mobile communication terminal (“external device”). Wherein, the treatment data includes: the negative pressure provided by the negative pressure therapy device in each period, the volume of wound exudate pumped by the negative pressure therapy device, and the wound exudate pumped by the negative pressure therapy device, the change curve of the volume and time of the exudate and the color and/or transparency of the volume of the wound exudate pumped by the negative pressure therapy device. Since the control center 100 is shown in FIG 4 as a smartphone, which is a device different from the negative pressure therapy devices 200 and 300, this acquisition of information by the smartphone corresponds to the recited “exporting”) through at least one of a serial communications interface and the wireless radio (par. 0042: the control center 100 is a mobile communication terminal (shown as a smartphone in FIG 4) connected to the negative pressure therapy devices 200 and 300 through a wireless network, specifically through infrared, Bluetooth, WiFi).”
Regarding claim 17, Pan teaches “wherein the external device comprises a personal computer device comprising a wireless radio configured to communicate with the plurality of negative pressure wound therapy devices (in FIG 4, the external device is shown as a smartphone which is also “a personal computer device comprising a wireless radio”. Paragraph 0042: the control center 100 is a mobile communication terminal connected to the negative pressure therapy devices 200 and 300 through a wireless network, specifically through infrared, Bluetooth, WiFi).”
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over CN 104225770 (Pan) in view of US 20110092958 (Jacobs) as applied to claim 17 above, and further in view of US 20170270763 (Hastings).
Regarding claim 18, Pan teaches “wherein the personal computer device comprises a smartphone configured to communicate wirelessly with the plurality of negative pressure wound therapy devices (in FIG 4, the external device (“the personal computer device”) is shown as a smartphone comprising a wireless radio communicating with the negative pressure therapy devices 200 and 300. Paragraph 0042: the control center 100 is a mobile communication terminal connected to the negative pressure therapy devices 200 and 300 through a wireless network, specifically through infrared, Bluetooth, WiFi)…”
Pan does not disclose that the communication is “through an application configured to cause the wireless radio of the smartphone to communicate with the wireless radio of the plurality of negative pressure wound therapy devices.”
In similar art, Hastings in paragraph 0004 teaches an NPWT unit capable of sending wireless notifications to an online dashboard application accessible in remote locations, via a wireless network. Alerts which appear on the NPWT unit will be transmitted out to the corresponding dashboard application which may be accessed on a remote computing device, such as a laptop or smartphone. Upon logging into the dashboard application, users will be able to diagnose the alert and figure out the proper course of action. The dashboard application will give full remote access to the NPWT unit, allowing users to troubleshoot and track any potential problems which may occur from a far.
In other words, Hastings teaches communication with negative pressure wound therapy device “through an application configured to cause the wireless radio of the smartphone to communicate with the wireless radio of the … of negative pressure wound therapy device.”
Therefore, it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application to utilize disclosed by Hastings usage of an application on the smartphone to communicate and control Pan’s plurality of negative pressure wound therapy devices. Doing so would have allowed the users to diagnose any alert given by the devices and figure out the proper course of action as well as give full remote access to the NPWT unit, allowing users to troubleshoot and track any potential problems which may occur from a far (see Hastings, paragraph 0004).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104225770 (Pan) in view of US 20110092958 (Jacobs) as applied to claim 16 above, and further in view of US 20180104391 (Luxon).
Regarding claim 19, while teaching “the external device (shown in FIG 4 control center 100, which is, in this embodiment, a mobile communication terminal, shown as a smartphone.)”, Pan does not teach that it “is further configured to send the information regarding the plurality of negative pressure wound therapy devices to at least one of a remote database, and a hospital infrastructure network.”
Luxon also teaches application of negative pressure to the wound (see FIG 1 and paragraph 0083). FIG 7 with corresponding description in paragraph 0114 teaches a data processing system 700 which may be used as part of a controller/monitor. Network computers, handheld computers, mobile devices, tablets, cell phones and other data processing systems may also be used. This would correspond to the mobile communication terminal serving as a control center 100 in the system of Pan. Paragraph 0162 further states that the controller is connected to a network, either wired or wireless, in order to transmit data to and/or from the patient's electronic medical record (EMR). The controller may also provide notifications of patient status on the controller/monitor itself and/or by transmitting notifications and/or safety alarms to the EMR. Paragraph 0139 further states that the volume and/or flow rate of the drained fluid may be measured and monitored over time or to monitor wound healing. Any of these measurements may be measurements made over time. These data may be integrated with the hospital's electronic medical record system (i.e. data may be communicated to) and/or displayed on a screen on the device or on a connected monitor, which may be connected either by wire or wirelessly.
Thus, Luxon teaches “send the information regarding the plurality of negative pressure wound therapy devices to … a remote database.”
Therefore, it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application to include disclosed by Luxon capability of transmitting information regarding the plurality of negative pressure wound therapy devices to the hospital's electronic medical record system, in the system of Pan. Doing so would have allowed to utilize centralized data depository that can be updated and accessed for the patient records.
Regarding claim 20, Pan in combination with Luxon teaches “wherein the remote database comprises an electronic medical records system (Luxon, paragraph 0162: the controller is connected to a network, either wired or wireless, in order to transmit data to and/or from the patient's electronic medical record (EMR). The controller may also provide notifications of patient status on the controller/monitor itself and/or by transmitting notifications and/or safety alarms to the EMR. Paragraph 0139: the volume and/or flow rate of the drained fluid may be measured and monitored over time or to monitor wound healing. These data may be integrated with the hospital's electronic medical record system (i.e. data may be communicated to) and/or displayed on a screen on the device or on a connected monitor, which may be connected either by wire or wirelessly.).”
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over CN 104225770 (Pan) in view of US 20110092958 (Jacobs) as applied to claim 15 above, and further in view of US 20210187171 (Collinson) (of record).
Regarding claim 21, Pan does not teach “further comprising exporting the information to an external network via at least one of a cellular dongle and a wired connection, wherein the external network comprises at least one of an external wireless network, a remote database, and a hospital infrastructure network.”
Collinson in FIG 1 – 2 with corresponding description also teaches negative pressure wound therapy device. The internal structure of the device is disclosed in FIG 3 with corresponding description. Further, paragraph 0058 teaches that a communications processor 330 can provide wired connectivity. Connectivity can be used for various activities, such as uploading of logs, alarms, and other operational data. Paragraph 0061: the following information can be uploaded to a remote computer or server through the communication processor 330: activity log(s), which includes therapy delivery information, such as therapy duration, alarm log(s), which includes alarm type and time of occurrence; error log. All this represents “exporting the information to an external network via … a wired connection”. Although not explicitly disclosed, it is either implicit, or it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application, that all this information being exported needs to be stored somewhere, thus arriving at “a remote database”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application to utilize disclosed by Collinson wired connection functionality with the capability of exporting various information pertaining to the negative pressure wound therapy devices, in the system of Pan. Doing so would have provided additional functionality to the system thus increasing its usefulness.
Regarding claim 22, Pan teaches “further comprising sending a command to one or more of the plurality of negative pressure wound therapy devices (paragraph 0053: to reduce the negative pressure of the negative pressure therapy device 200 connected to the control center 100, the operator can operate on the control center 100. The corresponding first negative pressure therapy device 200 is selected as the operation target. After receiving the operation instruction for the negative pressure therapy device 200, the control center 100 sends control information (“sending a command”) to the negative pressure therapy device 200.)…”
Pan does not teach “wherein the command comprises a directive to transition therapies of the plurality of negative pressure wound therapy devices between an active therapy state and an inactive therapy state.”
Collinson in FIG 1 – 2 with corresponding description also teaches negative pressure wound therapy device. Further, Collinson in paragraph 0051 teaches issuing a command to transition “between an active therapy state and an inactive therapy state (Button 212a can be configured as a power button to turn on/off the pump assembly 230. Button 212b can be configured as a play/pause button for the delivery of negative pressure therapy. For example, pressing the button 212b can cause therapy to start, and pressing the button 212b afterward can cause therapy to pause or end.)”.
Therefore, it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application to further combine the capability of remotely controlling negative pressure wound therapy devices, disclosed by Pan, with additional commands disclosed by Collinson of turning the pump assembly on/off or a play/pause operation of delivering the therapy. Doing so would have further expanded the capability of the system to additional commands.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over CN 104225770 (Pan) in view of US 20110092958 (Jacobs) and US 20210187171 (Collinson) as applied to claim 22 above, and further in view of US 20160287745 (Grinstaff).
Regarding claim 23, Pan in combination with Collinson teaches “wherein the active therapy state comprises at least one of negative pressure wound therapy and instillation therapy (Collinson discloses negative pressure wound therapy; paragraph 0051: Button 212a can be configured as a power button to turn on/off the pump assembly 230. Button 212b can be configured as a play/pause button for the delivery of negative pressure therapy. For example, pressing the button 212b can cause therapy to start (“the active therapy state” which is “negative pressure wound therapy”).)…”
Pan in combination with Collinson do not teach that “the inactive therapy state comprises changing an associated wound dressing.”
Grinstaff in paragraph 0183 teaches that when it is desired to remove the dissolvable hydrogel composition from the wound (e.g., when it is time to change the wound dressing or bandage), the vacuum or sub-atmospheric pressure applied to the wound can be turned off.
In other words, Grinstaff teaches “the inactive therapy state comprises changing an associated wound dressing.”
Therefore, it would have been obvious to a person of ordinary skill in the art at the effective filing date of the application to utilize transition to “the inactive therapy state” when it is time to change the wound dressing or bandage, in the system of combined Pan and Collinson’s disclosures. Doing so would have prevented possible malfunctioning of the device if the negative pressure is not turned off while changing the dressing.
Conclusion
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/GENNADIY TSVEY/ Primary Examiner, Art Unit 2648
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