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 Arguments
Applicant's arguments filed 15 April 2026 have been fully considered but they are not persuasive.
Regarding the argument that “Pratt's alarm is based on the morphological comparison of a single pressure decay curve, belonging to an event-triggered type, whereas the present application's alarm is based on the duration of deviation from the preset range, belonging to a cumulative, lag-triggered type”, it is noted that the features upon which applicant relies (i.e., cumulative, lag-triggered type) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Specifically, the time duration and the preset alarm time is not specified or claimed. Pratt compares pressure decay curves (¶ [0095], [0096], [0097], [0098]). This implies an alarm time or some comparison of time periods. Furthermore, Pratt discloses the claimed features as clarified below.
Applicant argues that Pratt has a different judgment logic than the present invention (remarks p. 7). However, none of the claims describe a cumulative duration exceedance, and at most call for a duration of pressure data deviation.
Status of Claims
As directed by the amendment filed on 15 April 2026: claim(s) 1, 5, 8, and 10 have been amended, claim(s) 3-4 & 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 8-10 is/are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Karpowicz et al. (US 20100022990 A1) in view of Pratt et al. (US 20220001100 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 the terminal controls the alarm apparatus to give an alarm when a time duration for which the pressure data deviates from the preset pressure range exceeds a preset alarm time. However, Pratt teaches a negative pressure wound therapy system ([0005]) wherein the negative pressure drainage system further comprises an alarm apparatus ("alert generator 156" [0059]; FIG. 4), the alarm apparatus is electrically connected with the terminal ([0058-0059]), and the terminal controls the alarm apparatus to give an alarm when a time duration for which the pressure data deviates from the preset pressure range exceeds a preset alarm time ("leak alarm is generated in response to a determination at step 1008 that the dynamic pressure response observed at step 1008 is not substantially the same as the dynamic pressure response observed at step 908 … a negative pressure circuit having a higher (i.e. more negative) initial target pressure will require more time to achieve a threshold pressure that would a negative pressure circuit of the same volume having a lower (i.e. less negative) initial target pressure, the dynamic pressure response within the negative pressure observed following the opening of the valve 132 in a situation in which a predetermined period of time was allowed to pass between the attainment of the target pressure and the purging of the negative pressure circuit will vary from the dynamic pressure response within the negative pressure observed following the opening of the valve 132 in a situation in which the purging of the negative pressure circuit occurred immediately after (or in less time than the predetermined time) following the attainment of the target pressure" [0096-0099]).
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 8, Karpowicz 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 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]).
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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Cheng Fong "Ted" Yang whose telephone number is (571)272-8846. The examiner can normally be reached 10am - 6pm (EST) M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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
Prosecution Insights