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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07/07/2025 has been entered.
Response to Amendment
The amendment filed 07/07/2025 has been entered. Claims 17, 46 and 61 have been amended. Claims 1-16, 30-45, 53 and 73 are cancelled. Claims 17-29, 46-52, 54-72, 74-77 remain pending in this application. Claims 46-52, 54-72, 74-77 are withdrawn.
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) 17-20, 22-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Robinson et al. (Pub. No.: US 2016/0015873 A1) in view of Locke et al. (Pub. No.: US 2022/0226559 A1)
Regarding claim 17, Robinson discloses (fig. 1, 3, annotated fig. 3) a mechanical wound therapy system (therapy system 100, ¶ 0018) comprising:
A dressing (102) comprising a top layer (cover 108) and a bottom layer (tissue interface 110), wherein:
The dressing is configured to be positioned adjacent to a wound (¶ 0028),
The bottom layer is configured to be positioned to face the wound (¶ 0028) and includes a set of perforations (¶ 0029);
A vacuum source (pump 146) configured to generate a vacuum pressure that produces a negative pressure differential nearby the wound (¶ 0060);
A regulator device (annotated fig. 3) configured to be directly coupled by suction tubing to the vacuum source (see pump inlet 145 and pump outlet 145 which fluidly connect to selector valve 148, ¶ 0060, components may be fluidly coupled through tubing ¶ 0020) and fluidly coupled by suction tubing between the dressing and the vacuum source to define a fluid pathway between the dressing and the vacuum source through the regulator device (fig. 1, 3, ¶ 0076), wherein the regulator device is configured to:
Regulate, using a pressure regulator (selector valve 148) of the regulator device, the vacuum pressure generated by the vacuum source and applied to the wound by limiting a magnitude of vacuum pressure to maintain a set value or range (¶ 0063), and
Monitor a set of parameters associated with the regulated vacuum pressure applied to the wound by the vacuum source (¶ 0077); and
An exudate canister (113) fluidly coupled by suction tubing between the regulator device and the dressing such that the fluid pathway extends from the dressing to the exudate canister and from the exudate canister to the regulator device (fig. 1, 3, ¶ 0019-¶ 0020).
PNG
media_image1.png
546
964
media_image1.png
Greyscale
Robinson annotated fig. 3
Robinson fails to disclose the dressing comprising a vacuum interface, wherein: the vacuum interface is positioned below the top layer of the dressing and accessible through the top layer of the dressing.
Locke teaches (fig. 1, 4) a mechanical wound therapy system (therapy system 100, abstract) and thus in the same field of endeavor, comprising:
a dressing (102) comprising a top layer (drape ring 413), a bottom layer (tissue interface 108/408) (¶ 0089) and a vacuum interface (dressing interface 107/400), wherein:
the vacuum interface is positioned below the top layer of the dressing (fig. 4) and accessible through the top layer of the dressing (fig. 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the dressing of Robinson such that it comprises a vacuum interface, wherein: the vacuum interface is positioned below the top layer of the dressing and accessible through the top layer of the dressing, as taught by Locke, in order to fluidly couple the dressing to the vacuum source (Locke ¶ 0054).
Further, such modification of Robinson in view of Locke results in: the regulator device fluidly coupled by suction tubing between the vacuum interface of the dressing and the vacuum source to define a fluid pathway between the vacuum interface and the vacuum source through the regulator device; and the exudate canister fluidly coupled by suction tubing between the regulator device and the vacuum interface of the dressing such that the fluid pathway extends form the vacuum interface of the dressing to the exudate canister.
Regarding claim 18, Robinson discloses wherein the regulator device comprises:
A processor that is configured to instruct the pressure regulator of the regulator device to regulate the vacuum pressure generated by the vacuum source and monitors the set of parameters associated with the regulated vacuum pressure (¶ 0069-¶ 0070, ¶ 0063).
Robinson in view of Locke fail to disclose wherein the processor is a microprocessor; and the regulator device comprising a communication module configured to transmit, for output, data representing the set of parameters monitored by the processor
Locke teaches (fig. 1) a regulator device (controller 110) comprising a microprocessor (¶ 0073).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor of Robinson in view of Thomson such that it is a microprocessor, as taught by Locke, as a microprocessor is suitable for operating a therapy system (Locke ¶ 0073) and in order to provide a more compact device.
Locke further teaches the regulator device comprising a communication module configured to transmit, for output, data representing the set of parameters monitored by the processor (¶ 0090).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the regulator device of Robinson in view of Locke such that it comprises a communication module configured to transmit, for output, data representing the set of parameters monitored by the processor, as taught by Locke, in order to allow the data to be displayed (Locke ¶ 0090).
Regarding claim 19, Robinson in view of Locke disclose (Locke fig. 24, 27) wherein:
the communication module comprises a near-field communication module (Locke ¶ 0091); and
the near-field communication module is configured to:
establish a short-range connection with a computing device (Locke, remote monitor 2420) that is within a proximity to the regulator device (Locke ¶ 162), and
transmit, over the short-range connection, the data representing the parameters to the computing device (Locke ¶ 0163).
Regarding claim 20, Robinson in view of Locke disclose (Locke fig. 24, 27) wherein the communication module comprises a Wi-Fi module (Locke ¶ 0148).
Regarding claim 22, Robinson in view of Locke disclose wherein the Wi-Fi module is configured to:
connect to a local area network; and
transmit, over the local area network, the data representing the parameters to a computing device connected to the local area network (Locke, ¶ 0163).
Regarding claim 23, Robinson in view of Locke disclose wherein the Wi-Fi module is configured to:
connect to a wide area network; and
transmit, over the wide area network, the data representing the parameters to a server that is remote from the regulator device (Locke ¶ 0158).
Regarding claim 24, Robinson discloses wherein regulation of the vacuum pressure applied by the vacuum source is programmable by a user (¶ 0069-¶ 0070).
Regarding claim 25, Robinson in view of Locke fail to disclose wherein the dressing, the vacuum source, and the regulator device each comprise circuitry configured to be in data communication with a remote monitoring system.
Locke teaches (fig. 4) the system further comprising a vacuum source (negative-pressure source 104) and a regulator device (controller 110); wherein the dressing, the vacuum source, and the regulator device each comprise circuitry configured to be in data communication with a remote monitoring system (¶ 0090).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Robinson in view of Locke such that the dressing, the vacuum source, and the regulator device each comprise circuitry configured to be in data communication with a remote monitoring system, as taught by Locke, in order to allow for an operator to control the system from a remote location (Locke ¶ 0090).
Regarding claim 26, Robinson in view of Locke discloses (Locke, fig. 28) wherein the circuitry of each of the dressing, the vacuum source and the regulator device is configured to receive error data via a wireless signal to the remote monitoring system (Locke, ¶ 0173-¶ 0177).
Regarding claim 27, Robinson discloses (fig. 3) wherein the regulator device comprises at least one sensor (therapy pressure sensor 158, ¶ 0059).
Robinson in view of Locke fail to disclose wherein the dressing and the vacuum source each comprise at least one sensor.
Locke teaches (fig. 4) the system further comprising a vacuum source (negative-pressure source 104), wherein the dressing (¶ 0088) and the vacuum source (electric sensor 124, ¶ 0056) each comprise at least one sensor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Robinson in view of Locke such that the dressing and the vacuum source each comprise at least one sensor, as taught by Locke, in order to detect a wound pressure (Locke ¶ 0088) and a pump pressure (Locke ¶ 0056).
Regarding claim 28, Robinson discloses wherein the bottom layer of the dressing is composed of plastic (polyvinyl alcohol ¶ 0031).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Locke, as applied to claim 18 above, and further in view of Askem et al. (Pub. No.: US 2022/0288298 A1).
Regarding claim 21, Robinson in view of Locke fail to disclose wherein the communication module encrypts or otherwise secures information being transmitted.
Askem teaches (fig. 1) a mechanical wound therapy system (reduced pressure wound treatment system 100) and thus in the same field of endeavor, comprising a communication module configured to transmit data (¶ 0006), wherein the communication module encrypts or otherwise secures the data being transmitted (¶ 0167).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to program the communication module of Robinson in view of Locke such that it encrypts or otherwise secures information being transmitted, as taught by Askem, in order to protect the data of the user.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Robinson in view of Locke, as applied to claim 17 above, in view of Locke et al. (Pub. No.: US 2020/0323692 A1), hereinafter Locke ‘692.
Regarding claim 29, Robinson in view of Locke fail to disclose wherein the bottom layer of the dressing is composed of a thermoplastic elastomer.
Locke ‘692 teaches (fig. 1) a mechanical wound therapy system (system 100, ¶ 0022) and thus in the same field of endeavor, comprising: a dressing (102) comprising a top layer (cover 106) and a bottom layer (manifold 120), wherein the bottom layer of the dressing is composed of a thermoplastic elastomer (¶ 0038).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the bottom layer of Robinson in view of Locke such that it is composed of a thermoplastic elastomer, as taught by Locke ‘692, as such materials allow fluid to pass (Locke ‘692 ¶ 0038).
Response to Arguments
Applicants arguments with respect to the restriction of claims 46-77 have been considered and are moot as claims 46-77 have been withdrawn.
Applicant’s arguments with respect to claim(s) 17 have been considered but are moot because the new ground of rejection relies newly cited Robinson in view of Locke for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Greener (Pub. No.: US 2019/0240381 A1) discloses a mechanical wound therapy device comprising a regulator device.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEAGAN NGO whose telephone number is (571)270-1586. The examiner can normally be reached M - TH 8:00 - 4:00 PT.
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, Sarah Al-Hashimi can be reached on (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MEAGAN NGO/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781