DETAILED ACTION
Note: The present application is being examined under the pre-AIA first to invent provisions.
This Office action is in response to preliminary claim amendments filed June 13, 2023.
Status of Claims
1. Claims 22-41 are pending and currently under consideration for patentability.
Claims 1-21 are canceled as of the June 13, 2023 preliminary claim amendment.
Priority
2. Acknowledgment is made of applicant's claim for foreign priority under 35 U.S.C. 119(a)-(d). The certified copy has been filed in the instant application.
Information Disclosure Statement
3. The information disclosure statement (IDS) submitted on June 12, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
4. Claims 22 and 33 are objected to because of the following informalities:
In the third to last line of claims 22 and 33, “…responsive to determining that the least one of the negative pressure…” appears to include a typographical error, and should read as ---…responsive to determining that [[at least one of the negative pressure…---.
Appropriate correction is required.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
5. Claims 22-41 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Risk, JR et al. (US PGPUB 2002/0198504 A1) in view of Manica (US 5,679,245).
6. With regard to claim 22, Risk discloses a negative pressure wound therapy apparatus (wound treatment apparatus, 2; abstract; Figs. 1, 2, 27, 30) comprising: a negative pressure source (vacuum source, 110; see Fig. 6) configured to provide reduced pressure via a fluid flow path (through evacuating tube, 20) to a wound covered by a wound dressing (bandage, 14; [0054]; [0070]); a pressure sensor (124) configured to monitor a pressure in the fluid flow path (Fig. 27; [0099]; [0102-0103]); a power source (power supply, 56) configured to provide power to the negative pressure source (110; [0059]; [0061]; [0076]); and a controller (50 or control unit, 803; see Figs. 2, 30; [0058]; [0070-0071]; [0147]) programmed to: responsive to receiving a request to initialize provision of negative pressure (pressing of any buttons 1014, 1016, 1018…1028 during power-saving mode; [0120]), test operation of at least one of the negative pressure source (110), pressure sensor (124), or power source (56; Power On Self-Test (POST); [0039]; [0121]); and responsive to verifying that at least one of the negative pressure source (110), pressure sensor (124), or power source (56) operates correctly, permit activation of the negative pressure source (110) to reduce pressure at the wound ([0136-0137]; [0071]).
While Risk discloses that the controller (50) monitors the status of all various sensors and motors ([0058]); that the controller (50) prevents system from operating if connections are improper ([0063]); and that absence of any vacuum in the system will cause the system to shut down ([0070]), Risk fails to explicitly disclose that the controller is programmed to: responsive to determining that the at least one of the negative pressure source, pressure sensor, or power source does not operate correctly, disable activation of the negative pressure source.
However, within the same field of endeavor of monitoring and controlling medical systems, Manica discloses a retention device for extracorporeal treatment apparatus (abstract; Figs. 1-4) comprising pumps (52, 62, 84, 68, 66), a pressure sensor (83), and a controller (control computer, 102 or control processor, 122 or 140) programmed to perform self-tests to determine the operational integrity operational components (col. 3, lines 33-35; col. 11, lines 23-31); and in response to determining that the at least one of the pumps (52, 62, 66, 68, 84) or pressure sensor (83) does not operate correctly, disable activation of the pumps (“safe-state”; col. 19, lines 41-51; col. 20, lines 33-42; col. 22, lines 32-37).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the controller programming disclosed by Risk to disable activation of the negative pressure source in response to determining that at least one of the negative pressure source, pressure sensor, or power source does not operate correctly, similar to that disclosed by Manica, in order to prevent the start of therapy until the user alleviates the malfunction/failure of system components such as the pressure sensor, ensuring proper treatment, as suggested by Manica in column 20, lines 32-42; and further to prevent the system from operating if connections are improper or vacuum is absent, as suggested by Risk in paragraphs [0063] and [0070], respectively.
6. With regard to claim 33, Risk discloses a method of operating a negative pressure wound therapy apparatus (wound treatment apparatus, 2; abstract; Figs. 1, 2, 27, 30), the method comprising: by a controller (50 or control unit, 803; see Figs. 2, 30; [0058]; [0070-0071]; [0147]) of the apparatus (2): responsive to receiving a request to initialize provision of negative pressure (pressing of any buttons 1014, 1016, 1018…1028 during power-saving mode; [0120]), test operation of at least one of a negative pressure source (110) of the apparatus (2), a pressure sensor (124) of the apparatus (2), or a power source (56) of the apparatus (2; Power On Self-Test (POST); [0039]; [0121]); and responsive to verifying that at least one of the negative pressure source (110), pressure sensor (124), or power source (56) operates correctly, permit activation of the negative pressure source (110) to reduce pressure at the wound ([0136-0137]; [0071]).
While Risk discloses that the controller (50) monitors the status of all various sensors and motors ([0058]); that the controller (50) prevents system from operating if connections are improper ([0063]); and that absence of any vacuum in the system will cause the system to shut down ([0070]), Risk fails to explicitly disclose that the controller is programmed to: responsive to determining that the at least one of the negative pressure source, pressure sensor, or power source does not operate correctly, disable activation of the negative pressure source.
However, within the same field of endeavor of monitoring and controlling medical systems, Manica discloses a retention device for extracorporeal treatment apparatus (abstract; Figs. 1-4) comprising pumps (52, 62, 84, 68, 66), a pressure sensor (83), and a controller (control computer, 102 or control processor, 122 or 140) programmed to perform self-tests to determine the operational integrity operational components (col. 3, lines 33-35; col. 11, lines 23-31); and in response to determining that the at least one of the pumps (52, 62, 66, 68, 84) or pressure sensor (83) does not operate correctly, disable activation of the pumps (“safe-state”; col. 19, lines 41-51; col. 20, lines 33-42; col. 22, lines 32-37).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the controller programming disclosed by Risk to disable activation of the negative pressure source in response to determining that at least one of the negative pressure source, pressure sensor, or power source does not operate correctly, similar to that disclosed by Manica, in order to prevent the start of therapy until the user services or alleviates the malfunction/failure of system components such as the pressure sensor, ensuring proper treatment, as suggested by Manica in column 20, lines 32-42; and further to prevent the system from operating if connections are improper or vacuum is absent, as suggested by Risk in paragraphs [0063] and [0070], respectively.
7. With regard to claims 23 and 34, Risk fails to explicitly disclose that the testing operation of the at least one of the negative pressure source, pressure sensor, or power source comprises at least one of: reading the pressure sensor to verify that the pressure is in a range of expected pressure values; or determining a remaining capacity of the power source and verifying that the remaining capacity is in a range of expected power source capacity values.
However, Manica discloses that the testing operation (“self-test”) of the at least one of the pumps (52, 62, 84, 68, 66), pressure sensor (83), or power source (“detect power loss”) comprises at least one of: reading the pressure sensor (83) to verify that the pressure is in a range of expected pressure values (col. 20, lines 33-42); or determining a remaining capacity of the power source and verifying that the remaining capacity is in a range of expected power source capacity values (col. 22, lines 32-47).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the controller testing operation disclosed by Risk in view of Manica to verify whether pressure sensor is in an expected range or determine a remaining power capacity, similar to that disclosed by Manica, in order to test for periodic preventive maintenance conducted to assure reliability while performing treatments, as suggested by Manica in column 22, lines 38-47; and further ensure that every component of the system is operational during the Power On Self-Test (POST), as suggested by Risk in paragraph [0121].
8. With regard to claims 24-25 and 35-36, while Risk discloses a memory ([0132]) as well as a Power On Self-Test (POST) ([0039]; [0121]), Risk fails to explicitly disclose that the controller is further programmed to: responsive to receiving the request to initialize provision of negative pressure, test operation of the memory; responsive to verifying that memory operates correctly, permit activation of the negative pressure source to reduce pressure at the wound; and responsive to determining that the memory does not operate correctly, disable activation of the negative pressure source; wherein testing operation of memory comprises verifying integrity of data stored in the memory, the data comprising instructions executable by the controller.
However, Manical discloses a memory (110, 123, 142), wherein the controller (122, 140) is further programmed to: responsive to receiving the request to initialize provision of therapy, test operation of the memory (110, 123, 142); responsive to verifying that memory operates correctly, permit activation of the pumps to reduce pressure at the wound (col. 3, lines 33-35; col. 11, lines 23-31); and responsive to determining that the memory does not operate correctly, disable activation of the pumps (col. 20, lines 43-55); wherein testing operation of memory (110, 123, 142) comprises verifying integrity of data stored in the memory (col. 3, lines 30-35; col. 20, lines 43-55), the data comprising instructions executable by the controller (122, 140; col. 7, lines 42-65).
Therefore, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the controller testing operation disclosed by Risk in view of Manica to verify whether memory is operating correctly and disable activation of negative pressure if operating incorrectly, similar to that disclosed by Manica, in order to test for periodic preventive maintenance conducted to assure reliability while performing treatments, as suggested by Manica in column 22, lines 38-47; to avoid memory malfunctions during therapy, as suggested by Manica in column 20, lines 43-55; and further ensure that every component of the system is operational during the Power On Self-Test (POST), as suggested by Risk in paragraph [0121].
9. With regard to claims 26-28 and 37-39, Risk discloses that the request to initialize provision of negative pressure comprises at least one of: insertion of one or more batteries ([0059]; [0107]; [0155]); or triggering of a switch (“momentary switch”) configured to activate the negative pressure source (110; [0088]; [0119]); wherein the apparatus (2) comprises a housing (4) enclosing at least the negative pressure source (110; Fig. 1; [0054]), the housing (4) comprising an exterior surface and the switch (“momentary switch”) comprising a sole button (possibly pause button, 1026 or enter button, 1022) supported by the exterior surface (at control panel, 10) of the housing (4) and configured to activate the negative pressure source (110; [0141]; [0117]).
10. With regard to claims 29 and 40, Risk, as modified by Manica in claims 22 and 33 above, discloses that the controller (50, 803) is further programmed to, responsive to verifying that the at least one of the negative pressure source (110), pressure sensor (124), or power source (56) operates correctly ([0136-0137]; [0071]): monitor a duration of time (using time meter, 1052; [0132]) subsequent to verification that the at least one of the negative pressure source (110), pressure sensor (124), or power source (56) operates correctly; and responsive to the duration of time (“value indicative of how long vacuum source 110 has operated”) satisfying a threshold indicative of reaching a therapy lifetime, disable activation of the negative pressure source (110; [0058]; [0070]).
11. With regard to claims 30 and 41, Risk, as modified by Manica in claims 22 and 33 above, discloses one or more indicators, wherein the controller (50, 803) is programmed to cause the one or more indicators to: provide a first indication (testing countdown, 1033; Fig. 30) responsive to testing operation of the at least one of the negative pressure source (110), pressure sensor (124), or power source (56; [0121]); provide a second indication (power LED, 1030) responsive to activating the negative pressure source (110) to reduce pressure at the wound ([0119]; [0137]); and provide a third indication (power LED, 1030 in off state; or information on control panel 10) responsive to disabling activation of the negative pressure source (110; [0070]), wherein the first, second, and third indications are different from one another ([0118-0119]; [0121]).
12. With regard to claim 31, Risk discloses a canister (26; Figs. 1, 6) configured to be positioned in the fluid flow path and store fluid removed from the wound ([0054]; [0069-0070]).
13. With regard to claim 32, Risk discloses a portable unit (see Fig. 8; [0054]) comprising the apparatus (2) of claim 22 (see rejection to claim 22 above, as modified by Manica) and the wound dressing (14; [0057]; [0089]).
While Risk and Manica fail to explicitly disclose that the portable unit is a kit, it would have been obvious to one having ordinary skill in the art before the invention was made to have modified the portable unit disclosed by Risk in view of Manica to be a kit, similar to that disclosed by Risk, in order to allows a caregiver to position it near the patient in preparation for treatment wherever the patient is located, as suggested by Risk in paragraph [0057]; and packaging a portable unit into a kit is well-known in the art of negative pressure wound dressing therapy, and would allow for ease of transport and storage of the portable unit, with a reasonable expectation of success.
Conclusion
14. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Paukovitz et al. (US PGPUB 2001/0051788 A1) discloses methods and apparatus for delivering fluids.
Bryant et al. (US PGPUB 2005/0100450 A1) discloses methods and systems for pulsed delivery of fluids from a pump.
15. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW J MENSH whose telephone number is (571)270-1594. The examiner can normally be reached M-F 9 a.m. - 6 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sarah Al-Hashimi can be reached at (571)272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW J MENSH/ Primary Examiner, Art Unit 3781