DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments, see page 6, filed 27FEB2026, with respect to the rejection(s) of claim(s) 6 and 17 under 35 U.S.C. § 102 have been fully considered and are moot in view of new grounds of rejection prompted by Applicant’s amendment to claims. A new ground(s) of rejection is made in view of Niezgoda in view of Eckstein. While Niezgoda teaches a system which is separated into different housings, Eckstein teaches a portable negative pressure wound therapy system which is integrated into a single housing for providing continuous therapy to a patient. Incorporating this design with the teachings of Niezgoda is considered to fulfill the amended claim limitations.
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.
Claim 6, 8, 10, 17, 19, 27, and 28 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 20100030132 A1 (Niezgoda et al.) in view of US 8540688 B2 (Eckstein et al.).
Regarding Claim 6, Niezgoda teaches a negative pressure wound treatment system (10) (Fig. 4) comprising:
a pressure source (70) configured to be fluidically connected to a wound dressing (100) placed over a wound via a fluid flow path (at least 66 and 90) and provide a negative pressure therapy to the wound [Abstract];
a pressure sensor configured to monitor a pressure in the fluid flow path ([0117] describing the possible sensors and their locations, including a sensor for fluid pressure);
at least one first processor (40) programmed to control the pressure source based on the pressure (the first processor controlling the dispensing pump and coordinating the activity of the dispensing pump and suction pump, thereby operating the suction pump [0124]);
a user interface (interface portions of remote computer system 50) configured to receive information regarding at least one of characteristics of the wound or the negative pressure therapy from a user (the user providing input for therapy control [0019], sample parameters for interaction via the graphical user interface detailed in [0164]);
a memory device configured to store the information (the remote computer system necessarily possessing memory 50); and
at least one second processor (the processor of remote computer system 50) programmed to:
instruct the at least one first processor to cause the pressure source to provide a continuous negative pressure therapy or an intermittent negative pressure therapy to the wound [0091], the continuous negative pressure therapy or the intermittent negative pressure therapy being provided in accordance with the information (the remote computer system sending instructions to control the therapy [0127]).
Eckstein teaches a negative pressure wound treatment system (2) (Figs. 1-6) comprising:
a pressure source (90) configured to be fluidically connected to a wound dressing (80) placed over a wound via a fluid flow path and to provide a negative pressure therapy to the wound (the flow path seen in Fig. 6 from the pressure source, through the vessel (10) and to the dressing);
a pressure sensor (94) configured to monitor a pressure in the fluid flow path (Fig. 6 showing the sensor in the described path);
at least one first processor (control unit (100) being considered to consist of at least one first processor) programmed to control the pressure source based on the pressure in the fluid flow path (Col. 8: ll. 60-65 describing the closed-loop control of the suction pump based on pressure sensor output);
a user interface (42);
a memory device configured to store the information (the device necessarily having memory for storing programming and setpoints);
at least one second processor (a touch screen being considered to necessarily possess a processor) programmed to:
control the user interface (Col. 8: ll. 60-65); and
instruct the at least one first processor to cause the pressure source to provide the negative pressure therapy to the wound continuously or intermittently (Col. 2: ll. 3-8); and
a housing (4) at least partially enclosing the pressure source, the at least one first processor, and the at least one second processor (seen in Fig. 6 schematically and physically in Figs. 1a-1e), wherein the user interface is at least partially positioned on an exterior surface of the housing (as seen in Fig. 1e).
While Eckstein teaches that the device is programmable and that different programs may be selected for operation, as well as that the device may be totally controlled through the display (Col. 8: ll. 63-65), the reference fails to explicitly state that the user interface is configured to receive information regarding at least one of characteristics of the wound or characteristics of the negative pressure therapy from a user, or the negative pressure therapy being provided in accordance with the information.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Niezgoda which allows for input of information, and the application of therapy based on said input to optimize conditions for wound healing [Niezgoda 0019] with the portable unit taught by Eckstein to allow the patient to be constantly treated, even while mobile (Eckstein Col. 1: ll. 30-33).
Regarding Claim 8, Niezgoda teaches the remote computer system (50) allows a user to control therapy [0019] and the ability to provide intermittent or continuous therapy [0091] and is therefore considered to teach the at least one second processor is programmed to: receive from a remote computing device an instruction to adjust a setting of the negative pressure therapy; and based on the setting, adjust provision of the negative pressure therapy to the wound.
Regarding Claim 10, the combined device, as taught in Claim 1 includes the touch-screen of Eckstein as a user interface.
Regarding Claim 17, Niezgoda teaches a method of operating a negative pressure wound treatment system (10) (Fig. 4), the method comprising:
by a user interface (interface portions of remote computer system 50), receiving information regarding at least one of characteristics of a wound or characteristic of a negative pressure therapy from a user (the user providing input for therapy control [0019], sample parameters for interaction via the graphical user interface detailed in [0164]);
by at least one first processor (40), controlling a pressure source (70) configured to be fluidically connected to a wound dressing (100) placed over the wound via a fluid flow path (at least 66 and 90) and provide the negative pressure therapy to the wound [Abstract]; and
by at least one second processor (the processor of remote computer system 50):
controlling the user interface (said processor necessarily controlling the display of the remote computer system)
instruct the at least one first processor to cause the pressure source to provide the negative pressure therapy to the wound continuously or intermittently [0091], the negative pressure therapy being provided in accordance with the information (the remote computer system sending instructions to control the therapy [0127]).
Niezgoda fails to teach a housing at least partially enclosing the claimed components.
Eckstein teaches a negative pressure wound treatment system (2) (Figs. 1-6) comprising:
a pressure source (90) configured to be fluidically connected to a wound dressing (80) placed over a wound via a fluid flow path and to provide a negative pressure therapy to the wound (the flow path seen in Fig. 6 from the pressure source, through the vessel (10) and to the dressing);
a pressure sensor (94) configured to monitor a pressure in the fluid flow path (Fig. 6 showing the sensor in the described path);
at least one first processor (control unit (100) being considered to consist of at least one first processor) programmed to control the pressure source based on the pressure in the fluid flow path (Col. 8: ll. 60-65 describing the closed-loop control of the suction pump based on pressure sensor output);
a user interface (42);
a memory device configured to store the information (the device necessarily having memory for storing programming and setpoints);
at least one second processor (a touch screen being considered to necessarily possess a processor) programmed to:
control the user interface (Col. 8: ll. 60-65); and
instruct the at least one first processor to cause the pressure source to provide the negative pressure therapy to the wound continuously or intermittently (Col. 2: ll. 3-8); and
a housing (4) at least partially enclosing the pressure source, the at least one first processor, and the at least one second processor (seen in Fig. 6 schematically and physically in Figs. 1a-1e), wherein the user interface is at least partially positioned on an exterior surface of the housing (as seen in Fig. 1e).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Niezgoda which allows for input of information, and the application of therapy based on said input to optimize conditions for wound healing [Niezgoda 0019] with the portable unit taught by Eckstein to allow the patient to be constantly treated, even while mobile (Eckstein Col. 1: ll. 30-33).
Regarding Claim 19, use of the device of Claim 8 is considered to fulfill the method of Claim 19.
Regarding Claim 27, Niezgoda in view of Eckstein, as taught in Claim 6 is considered to teach the at least one first processor is configured to control the pressure source with a first level of responsiveness that is higher than a second level of responsiveness with which the at least one second processor is configured to control the user interface as the first processor provides direct control of the pressure source, and would therefore necessarily have a higher responsiveness than the control through the user interface.
Regarding Claim 28, use of the device of Claim 27 is considered to fulfill the method of Claim 28.
Claim 7 and 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Niezgoda in view of US 10173008 B2 (Simpson et al.).
Regarding Claim 7, Niezgoda describes communication between the device and remote computer systems [0126], but fails to explicitly teach a network of remote computing device. Niezgoda therefore fails to teach the at least one second processor is programmed to cause transmission of at least some of the information to a remote computing device.
Simpson teaches a system for operation of medical device over a network [Abstract] wherein local devices communicate with different servers and databases (Fig. 1) (Col 6: l. 60 – Col. 7: l. 7).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Niezgoda to incorporate the server system of Simpson to allow care-givers to monitor status and provide care with a typical workflow (Simpson Col. 7: ll. 8-18).
The combined device is therefore considered to fulfill the requirement wherein the at least one second processor is programmed to cause transmission of at least some of the information to a remote computing device.
Regarding Claim 18, use of the device of claim 7 is considered to fulfill the method of claim 18.
Claim 11-16 and 20-24 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Niezgoda in view of Eckstein and further in view of US 8333744 B2 (Hartwell et al.).
Regarding Claims 11-14, Niezgoda fails to teach alarms.
Hartwell teaches a negative pressure wound treatment system which generates an alarm based on the pressure, namely of a leak (Col. 9: ll. 19-23); and provide the alarm to the user via the user interface (Col. 9: ll. 19-23 describes displaying a message to the user). Hartwell further teaches generation of a blockage alarm responsive to a detection of a blockage in the fluid flow path (Col. 9: ll. 27-29), as well as an alarm for a full canister (Col. 9: ll. 27-29).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Niezgoda to incorporate the alarms of Hartwell to alert the user of an abnormal condition (Hartwell claim 11).
The combined device is considered to fulfill the claim requirement of claims 11-14 as the processor is considered to control the alarm functions.
Regarding Claims 15 and 16, Niezgoda further teaches a canister (60) configured to store fluid aspirated from the wound [0094], but fails to teach a fluid sensor configured to monitor a level of fluid in the canister and generate a canister fluid level signal indicating the level of fluid in the canister or the at least one first processor is programmed to control the pressure source based on the canister fluid level signal.
Hartwell teaches a negative pressure wound treatment system wherein a fluid sensor configured to monitor a level of fluid in the canister and generate a canister fluid level signal indicating the level of fluid in the canister (by indicating a full container (Col. 5: ll. 2-4) and further teaches control of the pressure source based on the canister fluid level signal (cessation of aspiration, Col. 5: ll. 2-4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Niezgoda to incorporate the alarms and automatic operation control of Hartwell to allow the user to replace the container by automatically stopping the pump (Hartwell Col. 2: ll. 17-31).
.
Regarding Claim 20, use of the device of Claim 11 is considered to fulfill the method of Claim 20.
Regarding Claim 21, use of the device of Claim 12 is considered to fulfill the method of Claim 21.
Regarding Claim 22, use of the device of Claim 13 is considered to fulfill the method of Claim 22.
Regarding Claim 23, use of the device of Claim 14 is considered to fulfill the method of Claim 23.
Regarding Claim 24, use of the device of Claim 15 is considered to fulfill the method of Claim 24.
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 HANS KALIHER whose telephone number is (303)297-4453. The examiner can normally be reached Monday-Friday 08:00-05:00 MT.
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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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/HANS KALIHER/Examiner, Art Unit 3781
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781
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