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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 16 September 2026 has been entered.
Response to Arguments
Applicant’s arguments filed 16 September 2026 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Status of Claims
As directed by the amendment filed on 16 September 2026: claim(s) 1 have been amended, claim(s) 3-4 and 6-7 have been cancelled.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 5, and 10 is/are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Karpowicz et al. (US 20100022990 A1) in view of Askem et al. (US 20190358372 A1).
Regarding Claim 1, Karpowicz discloses a negative pressure drainage system ("wound therapy system" [0008]; FIG. 4), comprising:
a dressing ("dressing" [0008]) for being applied to a wound surface of a patient ("applied to a wound of a patient" [0008]);
a collecting device ("wound sensor array 3" [0038]), buried in the dressing ("placed into the wound space" [0038]) for collecting a pressure at the dressing in real time to obtain pressure data ("real time monitoring" [0017]); and
a receiving device ("wound therapy controller 5" [0038]), wirelessly connected with the collecting device, wherein the collecting device wirelessly is configured for transmitting the pressure data to the receiving device ("wound sensor array 3 is a disc shaped device that has internal power source, select sensor technologies and is wired or has a wireless transmitter for communication capability for conveying key information back to the wound therapy controller 5" [0038]);
wherein the negative pressure drainage system further comprises a terminal ("server 427" [0054]; FIG. 4), the receiving device is wirelessly connected with the terminal ("wound therapy controller 5 communicates with a server 427 via therapy unit wireless communications 437" [0054]), the receiving device wirelessly transmits the pressure data to the terminal, and the terminal is configured for processing the pressure data ([0024-0025]);
wherein the negative pressure drainage system further comprises a negative pressure device (comprising at least of "pump 35 and motor 36" [0047], "suction delivery tube 432" [0051], and "packing 2" [0037]; FIGs. 3-4), the negative pressure device is at least partially buried in the dressing ("Suction created from this pump is applied to the patient wound bed W via suction delivery tube 432 which penetrates the wound cover 4 through tube attachment device 431" [0051]; FIG. 4), the negative pressure device is configured for providing a negative pressure at the dressing ("Pump 35 is preferably a positive displacement type of pump employing a diaphragm and inlet and outlet valves to reliably supply negative pressure to the collection circuit" [0047]), the negative pressure device is electrically connected with the terminal ([0047-0049]; FIG. 3), and the terminal is configured for adjusting a pressure provided by the negative pressure device according to the pressure data ([0014-0015] & [0024-0025]);
wherein the terminal is configured for adjusting the negative pressure device to enable the pressure data to be within a preset pressure range ("controller may include a receiver to receive downloaded information from the central server, wherein the information is information such as updated operating software, clinical operating protocols, and user defined settings" [0014]; "downloading information from a central server to the controller, such as updated operating software, clinical operating protocols, and user defined settings" [0024]; "control algorithm maintains this pressure within prescribed limits" [0044]).
Karpowicz fails to specify the negative pressure drainage system further comprises an alarm apparatus, the alarm apparatus is electrically connected with the terminal, and wherein the terminal is provided with a preset alarm time and a pressure adjustment range for the negative pressure device and is configured to: (a) monitor a time duration for which the pressure data continuously deviates from the preset pressure range, and in response to the time duration exceeding the preset alarm time, control the alarm apparatus to give an alarm; and (b) monitor whether a pressure adjustment of the negative pressure device by the terminal reaches an end value of the pressure adjustment range, and in response to the pressure data still remaining outside the preset pressure range after the pressure adjustment reaches the end value, control the alarm apparatus to give an alarm; wherein the preset pressure range is a pressure numerical range set on the terminal according to a healing condition of the wound surface of the patient. However, Askem teaches “a pump system or assembly for providing negative pressure to a wound site” ([0005]) wherein the negative pressure drainage system further comprises an alarm apparatus ("pump assembly 150 can include visual, audible, tactile, and other types of indicators or alarms configured to signal to the user various operating conditions" [0128]), the alarm apparatus is electrically connected with the terminal ([0127-0128; FIG. 3A]), and
wherein the terminal is provided with a preset alarm time ("alarms configured to signal to the user various operating conditions" [0128]) and a pressure adjustment range for the negative pressure device ("error between the target level of negative pressure and actual negative pressure at the wound" [0240]) and is configured to: (a) monitor a time duration for which the pressure data continuously deviates from the preset pressure range ("negative pressure at the wound falls below the target level of negative pressure (for example, below an threshold level in relation to the target level of negative pressure)" [0241]), and in response to the time duration exceeding the preset alarm time, control the alarm apparatus to give an alarm ("alarm indicator 116A can glow red or flash to indicate a malfunction in the operation of the pump assembly 150A" [0144]); and (b) monitor whether a pressure adjustment of the negative pressure device by the terminal reaches an end value of the pressure adjustment range, and in response to the pressure data still remaining outside the preset pressure range after the pressure adjustment reaches the end value, control the alarm apparatus to give an alarm ("leakage can be detected when a target negative pressure has not been reached over a duration of time" [0244]); wherein the preset pressure range is a pressure numerical range set on the terminal according to a healing condition of the wound surface of the patient ("target level of negative pressure may be set to a particular value" [0239]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Karpowicz to incorporate the teachings of Askem to suitably detect leaks in the negative pressure system ([0025]) and “signal to the user various operating conditions” ([0128]).
Regarding Claim 2, Karpowicz discloses the collecting device comprises a first wireless module ("sensor wireless transmitter 415" [0049]; FIG. 4), the receiving device comprises a second wireless module ("therapy unit local antenna 424" [0049]), the first wireless module is wirelessly connected with the second wireless module for realizing wireless communication between the collecting device and the receiving device ("sensor array 3 communicates with the wound therapy controller 5 either via sensor wireless transmitter 415 facilitating sensor array wireless communications 434" [0049]).
Regarding Claim 5, Karpowicz discloses the negative pressure device comprises a conduction pipe ("suction delivery tube 432" [0051]; FIG. 4), the conduction pipe extends into the dressing ("penetrates the wound cover 4" [0051]), the conduction pipe is configured for conveying waste liquid at the dressing ("exudate removed from patient wound bed W through suction delivery tube 432" [0051]), and the collecting device is configured for collecting a pressure of the conduction pipe in the dressing ([0049]; FIG. 4).
Regarding Claim 10, Karpowicz discloses receiving device further comprises a storage ("memory card" [0047]; FIG. 3), the storage is configured for storing the pressure data ("data record can be downloaded to an external memory drive" [0076]), the storage is electrically connected with the terminal ([0056]; FIG. 3), and the terminal is configured for reading the pressure data of the storage ([0047]; FIG. 3).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Karpowicz et al. (US 20100022990 A1) in view of Askem et al. (US 20190358372 A1) and further in view of Pratt et al. (US 20220001100 A1).
Regarding Claim 8, Karpowicz/Askem fails to specify the receiving device further comprises a display, and the display is configured for displaying the pressure data in real time. However, Pratt teaches the receiving device further comprises a display, and the display is configured for displaying the pressure data in real time ("User interface 148 may also include one or more display devices (e.g., LEDs. LCD displays, etc.), speakers, tactile feedback devices, or other output devices configured to provide information to a user. In some embodiments, the pressure measurements recorded by pressure sensor 130 are presented to a user via user interface 148" [0059]; FIG. 4).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the device of Karpowicz/Askem to incorporate the teachings of Pratt to suitably “alert a user to such anomalous operation of the wound therapy system and/or identify and alert a user to an underlying cause (e.g, blockage and/or leak, etc.) that is responsible for the anomalous readings” (Abstract).
Regarding Claim 9, Karpowicz discloses the negative pressure drainage system comprises a plurality of collecting devices and a plurality of receiving devices, the collecting devices correspond to the receiving devices one by one, the terminal is electrically connected with the plurality of receiving devices ([0024]-[0025]; NOTE: it is implied by the term "central server" that a plurality of collecting devices & receiving devices may be electrically connected with the terminal), and the display is further configured for displaying attribute information of each of the receiving devices ("displayed as a colored indicator to the patient" [0079]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca E. Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Adam Marcetich/Primary Examiner, Art Unit 3781
Cheng Fong "Ted" Yang
Examiner
Art Unit 3781
