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 Amendment
An amendment was filed on 10/14/2025. Claims 1, 16, and 21 have been amended. Currently, claims 1, 3-12, and 14-21 are pending and are being examined on the merits.
Allowable Subject Matter
Allowable subject matter was proposed with respect to claims 1, 3-12, and 14-21 on 10/14/2025. However, upon further consideration, the amendment to overcome the proposed 112(a) rejection has the claim rejectable under Freedman as described below.
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 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.
Claim 1, 3, 6, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman (US 20140066868) in view of McCarthy (US 20050147656), and further in view of Russo (US 4261363), Cartmell (US 5674523), and Pratt (US 20200139024).
Regarding claim 1, Freedman discloses a wound management system for monitoring and controlling environmental conditions of a skin exit site of a medical appliance crossing a skin barrier of a patient (fig. 14, apparatus utilizing a pressure sensor for a wound, shown as element 1307 in fig. 13B, paragraph 0153) comprising:
a skin protecting layer having an outer surface and an opposite skin side surface (fig. 14, irrigation tubing web above accessory tube 1401, said layer shown as element 115), the skin side surface configured to contact the skin barrier of the patient outside of the skin exit site and surround the skin exit site of the medical appliance (paragraph 0158, “irrigation tubing system may be configured to lie proximate of the wound surface (e.g., within 1 mm, or within 1 layer of netting”), the skin protecting layer defining a through hole therein through which the medical appliance is configured to pass (),a wound dressing configured to be positioned over the skin exit site of the medical appliance () and over the skin protection layer, said wound dressing defining a wound environment (see annotated fig. 14 below);
at least one of a humidity sensor, a pressure sensor, a temperature sensor, and a chemical sensor integrated into the wound dressing to provide physiologic parameters that correlate to a degree of wound healing (fig. 14, pressure sensor, shown as element 119 in fig. 1C, is integrated into the wound dressing via a cable and an interface below the wound dressing);
a pump in fluid communication with said wound environment (paragraph 0170 describes the accessory tube 1401 conveying vacuum, thus implying a vacuum pump), said wound environment defining a volume above the outer surface of the skin protection layer, the volume consisting of a portion of the medical appliance proximal to the exit site, wound exudate, and air (fig. 14, with irrigation tubing adjacent the wound, and accessory tube configured to be placed within the depths of the wound, paragraph 0171. Thus, the wound environment is defined by a volume comprising the accessory tube portion inside the body, the wound exudate in the wound, see annotated fig. 14 below).
PNG
media_image1.png
781
833
media_image1.png
Greyscale
Freedman in fig. 14 is silent to wherein the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, a strain relieving fixture in said wound dressing configured to stabilize passage of the medical appliance through the wound dressing, an observation window in said wound dressing providing a direct view of the exit site of the medical appliance without removing any portion of said wound dressing, wherein the air in the wound environment has an intentional leak into the volume, and a controller configured to control operation of said pump, said controller configured to receive input from the at least one of said humidity sensor, said pressure sensor, said temperature sensor, and said chemical sensor integrated into the wound dressing and to control operation of said pump.
However, McCarthy teaches a tissue dressing assembly (abstract) covering a skin exit site of a medical appliance (88) crossing a skin barrier of a patient (fig. 40 shows indwelling catheter 88 crossing through gasket assembly 82), comprising a strain relieving fixture in said wound dressing configured to stabilize passage of the medical appliance (88) through the wound dressing (fig. 40, gasket formed to stabilize the catheter 88 and is thus capable of relieving strain, paragraph 0047, also see paragraph 0257, “to provide a tight, sealed fit”).
Therefore, 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 device disclosed in Freeman such that the wound management system monitors and controls environmental conditions of a skin exit site of a medical appliance crossing a skin barrier of a patient, with the wound dressing positioned over the skin exit site, a strain relieving fixture in said wound dressing configured to stabilize passage of the medical appliance through the wound dressing, as taught and suggested by McCarthy, for the purpose of providing a suitable structure that allows the wound dressing to accommodate an indwelling catheter (see McCarthy, paragraph 0257), thus allowing the assembly to apply negative pressure wound therapy to a specific area of an exit site.
Freedman, as modified by McCarthy, fails to teach wherein the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, and an observation window in said wound dressing providing a direct view of the exit site of the medical appliance without removing any portion of said wound dressing.
However, Russo teaches a retention clip for a body fluid drain (abstract) that allows for the medical appliance (14) to be held parallel to the clip, both inside the skin and outside (fig. 2, drain 14 is held parallel below body surface 20 and above body surface 20, col. 3, lines 5-15, “the clip turns drain 14 from a direction extending substantially perpendicular to the outer surface 20 to a direction substantially parallel to outer surface 20.”). The retention clip is substantially pertinent to the strain relieving structure taught in McCarthy.
Therefore, 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 device disclosed in Patel in view of McCarthy such that the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, as suggested by Russo, for the purpose of providing a suitable structure that allows the drain to prevent movement of the drain and provide for patient comfort (see Russo, col. 3, lines 5-15), as well as prevent crimping of the drain (see Russo, col. 1, lines 49-61).
Freeman fails to teach an observation window in said wound dressing providing a direct view of the exit site of the medical appliance without removing any portion of said wound dressing.
However, Cartmell teaches a wound dressing (abstract) comprising an observation window (28) in combination with a see-through packing hydrogel layer (14) providing a direct view of a wound in the wound area without removing any portion of said wound dressing (col. 4, lines 41, 47, “the use of a transparent film 28 over the open area 26 in the barrier layer allows medical personnel to monitor healing of the wound visually without removing the wound dressing”, also see col. 2, lines 40-46).
Therefore, 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 device disclosed in Freedman to comprise an observation window in combination with a see through packing hydrogel providing a direct view of a wound in the wound area without removing any portion of said wound dressing, as taught by Cartmell, for the purpose of providing a suitable structure that allows personnel to monitor the healing of the wound dressing visually without removing the wound dressing (see Cartmell, col. 4, lines 33-40).
Freedman is silent to a controller configured to receive input from the pressure sensor and to control operation of said pump, and does not teach wherein the volume consists of, among other claimed elements, air with an intentional leak into the volume.
However, Pratt teaches a negative pressure wound therapy system (abstract) comprising a controller to control the operation of a pump (paragraph 0084 describes negative pressure pump 120 controlled by controller 118) and defines an intentional leak (113a) (fig. 6B, vent 113a). Pratt also shows a pressure sensor that is integrated into the wound dressing while being outside of the defined volume (fig. 2, pressure sensor 115b and 115a in communication with drape layer 117), such that the volume does not comprise the pressure sensor.
Therefore, 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 device disclosed in Freedman such that the volume comprises air with an intentional leak into the volume, as taught by Pratt, for the purpose of providing a suitable structure that vents the wound dressing to the atmosphere after reaching a desired negative pressure (see Pratt, paragraph 0067).
Moreover, 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 device disclosed in Freedman such that a controller is configured to receive input from the pressure sensor and to control the operation of said pump, as taught by Pratt, for the purpose of providing a suitable structure that can stop application of negative pressure once a desired negative pressure is reached (see Pratt, paragraph 0067).
Regarding claim 3, Freeman discloses the system further comprising an extrudate reservoir (fig. 1A, collection canister 106 utilized in multiple embodiments).
Regarding claim 6, Freedman discloses wherein said medical appliance is a catheter (), but is silent to wherein said wound dressing is compliant, said wound dressing configured to accommodate a variety of catheter diameters.
However, McCarthy teaches wherein the pad assembly is made of compliant material (paragraph 0192).
Therefore, 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 device disclosed in Freedman such that the wound dressing is compliant, as taught by McCarthy, for the purpose of providing a suitable material that allows the dressing to conform to the patient’s anatomy.
Freedman, as modified by McCarthy, is silent to wherein the wound dressing is configured to accommodate a variety of catheter diameters.
However, the tissue dressing (10) of McCarthy is compliant (paragraph 0192), and an embodiment in FIG. 42 has a pass-through hole (90) that accommodates passage (paragraph 0258). Because the dressing (10) is compliant, the pass-through hole (90) can accommodate a variety of catheter diameters.
Therefore, 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 device disclosed in Freedman in view of McCarthy such that the wound dressing is configured to accommodate a variety of catheter diameters, as suggested by FIG. 42 of McCarthy, for the purpose of providing a suitable structure that lets the dressing to be configured proportionate to the area of the access site (see McCarthy, paragraph 0258).
Regarding claim 16, Freedman discloses a method for measuring and monitoring wound conditions of a patient (abstract) comprising:
placing a skin protection layer (see annotated fig. 14 below, pointing to a feature noted as irrigation tubing layer 115 in fig. 1C shown in various embodiments) having an outer surface and an opposite skin side surface in contact with a skin barrier of the patient outside of the skin exit site and surrounding a skin exit site of a medical appliance (fig. 14 shows a surface below and a surface above as a skin side surface and outer surface respectively, paragraph 0157 describes the irrigation tubing system lying proximate the wound surface, within 1 mm.)
passing the medical appliance (1401) through a through hole defined in the skin protection layer (fig. 14, accessory tube 1401 goes through hole in skin protection layer as defined)
placing a wound dressing on over the wound over the exit site of the medical appliance crossing the skin barrier of the patient, said wound defining a wound environment (see annotated fig. 14 below, the wound dressing configured to be placed over accessory tube 1401 and to be placed over a wound environment),
placing one or more sensors for measuring parameters that correlate to a degree of wound healing at the skin barrier of the patient (fig. 14 shows a pressure sensor denoted as element 119 in fig. 1C);
providing a pump in fluid communication with said wound environment, said wound environment defining a volume above the outer surface of the skin protection layer (paragraph 0170 describes the accessory tube 1401 conveying vacuum, thus implying a vacuum pump),, the volume consisting of a portion of the medical appliance proximal to the exit site, wound exudate, and air with an intentional leak into the volume (fig. 14, with irrigation tubing adjacent the wound, and accessory tube configured to be placed within the depths of the wound, paragraph 0171. Thus, the wound environment is defined by a volume comprising the accessory tube portion inside the body, the wound exudate in the wound, see annotated fig. 14 below)
wherein said one or more sensors are incorporated into the wound dressing positioned to cover the wound (fig. 14, pressure sensor, shown as element 119 in fig. 1C, is integrated into the wound dressing via a cable and an interface below the wound dressing) .
PNG
media_image2.png
781
833
media_image2.png
Greyscale
Freedman fails to teach the method wherein the medial appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, wherein the wound dressing has an observation window that provides a direct view of the exit site of the medical appliance without removing any portion of said wound dressing, wherein the method comprises stabilizing passage of the medical appliance through the wound dressing using a strain relieving fixture in said wound dressing, wherein the volume of the wound environment consists of, among other claimed elements, air with an intentional leak into the volume, and providing a controller configured to receive input from at least one sensor comprising a humidity sensor, a pressure sensor, a temperature sensor, and a chemical sensor and to control operation of said pump.
However, McCarthy teaches a wound dressing over an exit site of a medical appliance crossing a skin barrier of a patient (abstract), which involves the method of stabilizing passage of the medical appliance through the wound dressing using a strain relieving fixture in said wound dressing (fig. 40 shows indwelling catheter 88 crossing through gasket assembly 82 using a strain relieving fixture 12 to stabilize the catheter 88).
Therefore, 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 method disclosed in Smith such that it involves stabilizing passage of the medical appliance through the wound dressing using a strain relieving fixture in said wound dressing, as taught and suggested by McCarthy, for the purpose of providing a suitable structure that allows the wound dressing to accommodate an indwelling catheter (see McCarthy, paragraph 0257), thus allowing the assembly to apply negative pressure wound therapy to a specific area of an exit site.
Freedman, as modified by McCarthy, fails to teach wherein the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, wherein the wound dressing has an observation window that provides a direct view of the exit site of the medical appliance without removing any portion of said wound dressing.
However, Russo teaches a retention clip for a body fluid drain (abstract) that allows for the medical appliance (14) to be held parallel to the clip, both inside the skin and outside (fig. 2, drain 14 is held parallel below body surface 20 and above body surface 20, col. 3, lines 5-15, “the clip turns drain 14 from a direction extending substantially perpendicular to the outer surface 20 to a direction substantially parallel to outer surface 20.”). The retention clip is substantially pertinent to the strain relieving structure taught in McCarthy.
Therefore, 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 method disclosed in Freedman in view of McCarthy such that the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, as suggested by Russo, for the purpose of providing a suitable structure that allows the drain to prevent movement of the drain and provide for patient comfort (see Russo, col. 3, lines 5-15), as well as prevent crimping of the drain (see Russo, col. 1, lines 49-61).
Freedman fails to teach wherein the wound dressing has an observation window that provides a direct view of the exit site of the medical appliance without removing any portion of said wound dressing.
Cartmell teaches a wound dressing (abstract) comprising an observation window (28) in combination with a see through packing hydrogel layer (14) providing a direct view of a wound in the wound area without removing any portion of said wound dressing (col. 4, lines 41, 47, “the use of a transparent film 28 over the open area 26 in the barrier layer allows medical personnel to monitor healing of the wound visually without removing the wound dressing”, also see col. 2, lines 40-46).
Therefore, 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 method disclosed in Smith such that the wound dressing has an observation window in combination with see through packing material that provides a direct view of the exit site of the medical appliance without removing any portion of said wound dressing, as taught by Cartmell, for the purpose of providing a suitable structure that allows personnel to monitor the healing of the wound dressing visually without removing the wound dressing (see Cartmell, col. 4, lines 33-40).
Freedman is silent to a controller configured to receive input from the pressure sensor and to control operation of said pump, and does not teach wherein the volume consists of, among other claimed elements, air with an intentional leak into the volume.
However, Pratt teaches a negative pressure wound therapy system (abstract) comprising a controller to control the operation of a pump (paragraph 0084 describes negative pressure pump 120 controlled by controller 118) and defines an intentional leak (113a) (fig. 6B, vent 113a). Pratt also shows a pressure sensor that is integrated into the wound dressing while being outside of the defined volume (fig. 2, pressure sensor 115b and 115a in communication with drape layer 117), such that the volume does not comprise the pressure sensor.
Therefore, 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 method disclosed in Freedman such that the volume comprises air with an intentional leak into the volume, as taught by Pratt, for the purpose of providing a suitable structure that vents the wound dressing to the atmosphere after reaching a desired negative pressure (see Pratt, paragraph 0067).
Moreover, 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 method disclosed in Freedman such that a controller is configured to receive input from the pressure sensor and to control the operation of said pump, as taught by Pratt, for the purpose of providing a suitable structure that can stop application of negative pressure once a desired negative pressure is reached (see Pratt, paragraph 0067).
Claim 4 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Levy (20180289556).
Regarding claim 4, Freedman does not teach an air quality sensor integrated into the wound dressing to provide physiologic parameters indicative of infection.
However, Levy teaches a wound covering apparatus (abstract) comprising an air quality sensor (1510E/1520E) integrated into the wound dressing to provide physiologic parameters indicative of infection (fig. 15, sensor 1510E or 1520E may be air quality sensors, paragraph 0122).
Therefore, 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 device disclosed in Freedman such that the system further comprises an air quality sensor integrated into the wound dressing to provide physiologic parameters indicative of infection, as taught by Levy, for the purpose of providing a suitable structure that determines if the air surrounding the wound contains harmful bacteria (see Levy, paragraph 0122).
Regarding claim 21, Freedman discloses a wound management system for monitoring and controlling environmental conditions of a skin exit site of a medical appliance crossing a skin barrier of a patient (fig. 14, apparatus utilizing a pressure sensor for a wound, shown as element 1307 in fig. 13B, paragraph 0153) comprising:
a skin protecting layer having an outer surface and an opposite skin side surface (fig. 14, irrigation tubing web above accessory tube 1401, said layer shown as element 115), the skin side surface configured to contact the skin barrier of the patient outside of the skin exit site and surround the skin exit site of the medical appliance (paragraph 0158, “irrigation tubing system may be configured to lie proximate of the wound surface (e.g., within 1 mm, or within 1 layer of netting”), the skin protecting layer defining a through hole therein through which the medical appliance is configured to pass (),a wound dressing configured to be positioned over the skin exit site of the medical appliance () and over the skin protection layer, said wound dressing defining a wound environment (see annotated fig. 14 below);
at least one of a humidity sensor, a pressure sensor, a temperature sensor, and a chemical sensor integrated into the wound dressing to provide physiologic parameters that correlate to a degree of wound healing (fig. 14, pressure sensor, shown as element 119 in fig. 1C, is integrated into the wound dressing via a cable and an interface below the wound dressing);
a pump in fluid communication with said wound environment (paragraph 0170 describes the accessory tube 1401 conveying vacuum, thus implying a vacuum pump), said wound environment defining a volume above the outer surface of the skin protection layer, the volume consisting of a portion of the medical appliance proximal to the exit site, wound exudate, and air (fig. 14, with irrigation tubing adjacent the wound, and accessory tube configured to be placed within the depths of the wound, paragraph 0171. Thus, the wound environment is defined by a volume comprising the accessory tube portion inside the body, the wound exudate in the wound, see annotated fig. 14 below).
PNG
media_image1.png
781
833
media_image1.png
Greyscale
Freedman in fig. 14 is silent to wherein the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, a strain relieving fixture in said wound dressing configured to stabilize passage of the medical appliance through the wound dressing, an observation window in said wound dressing providing a direct view of the exit site of the medical appliance without removing any portion of said wound dressing, an air quality sensor integrated into the wound dressing to provide physiologic parameters indicative of infection, wherein the air in the wound environment has an intentional leak into the volume, and a controller configured receive input from the at least one of said humidity sensor, said pressure sensor, said temperature sensor, and said chemical sensor integrated into the wound dressing and to control operation of said pump.
However, McCarthy teaches a tissue dressing assembly (abstract) covering a skin exit site of a medical appliance (88) crossing a skin barrier of a patient (fig. 40 shows indwelling catheter 88 crossing through gasket assembly 82), comprising a strain relieving fixture in said wound dressing configured to stabilize passage of the medical appliance (88) through the wound dressing (fig. 40, gasket formed to stabilize the catheter 88 and is thus capable of relieving strain, paragraph 0047, also see paragraph 0257, “to provide a tight, sealed fit”).
Therefore, 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 device disclosed in Freeman such that the wound management system monitors and controls environmental conditions of a skin exit site of a medical appliance crossing a skin barrier of a patient, with the wound dressing positioned over the skin exit site, a strain relieving fixture in said wound dressing configured to stabilize passage of the medical appliance through the wound dressing, as taught and suggested by McCarthy, for the purpose of providing a suitable structure that allows the wound dressing to accommodate an indwelling catheter (see McCarthy, paragraph 0257), thus allowing the assembly to apply negative pressure wound therapy to a specific area of an exit site.
Freedman, as modified by McCarthy, fails to teach wherein the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, and an observation window in said wound dressing providing a direct view of the exit site of the medical appliance without removing any portion of said wound dressing.
However, Russo teaches a retention clip for a body fluid drain (abstract) that allows for the medical appliance (14) to be held parallel to the clip, both inside the skin and outside (fig. 2, drain 14 is held parallel below body surface 20 and above body surface 20, col. 3, lines 5-15, “the clip turns drain 14 from a direction extending substantially perpendicular to the outer surface 20 to a direction substantially parallel to outer surface 20.”). The retention clip is substantially pertinent to the strain relieving structure taught in McCarthy.
Therefore, 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 device disclosed in Patel in view of McCarthy such that the medical appliance is parallel to the skin protection layer on both the outer surface and the skin side surface, as suggested by Russo, for the purpose of providing a suitable structure that allows the drain to prevent movement of the drain and provide for patient comfort (see Russo, col. 3, lines 5-15), as well as prevent crimping of the drain (see Russo, col. 1, lines 49-61).
Freeman fails to teach an observation window in said wound dressing providing a direct view of the exit site of the medical appliance without removing any portion of said wound dressing.
However, Cartmell teaches a wound dressing (abstract) comprising an observation window (28) in combination with a see-through packing hydrogel layer (14) providing a direct view of a wound in the wound area without removing any portion of said wound dressing (col. 4, lines 41, 47, “the use of a transparent film 28 over the open area 26 in the barrier layer allows medical personnel to monitor healing of the wound visually without removing the wound dressing”, also see col. 2, lines 40-46).
Therefore, 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 device disclosed in Freedman to comprise an observation window in combination with a see through packing hydrogel providing a direct view of a wound in the wound area without removing any portion of said wound dressing, as taught by Cartmell, for the purpose of providing a suitable structure that allows personnel to monitor the healing of the wound dressing visually without removing the wound dressing (see Cartmell, col. 4, lines 33-40).
Freedman is silent to a controller configured to receive input from the pressure sensor and to control operation of said pump, and does not teach wherein the volume consists of, among other claimed elements, air with an intentional leak into the volume.
However, Pratt teaches a negative pressure wound therapy system (abstract) comprising a controller to control the operation of a pump (paragraph 0084 describes negative pressure pump 120 controlled by controller 118) and defines an intentional leak (113a) (fig. 6B, vent 113a). Pratt also shows a pressure sensor that is integrated into the wound dressing while being outside of the defined volume (fig. 2, pressure sensor 115b and 115a in communication with drape layer 117), such that the volume does not comprise the pressure sensor.
Therefore, 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 device disclosed in Freedman such that the volume comprises air with an intentional leak into the volume, as taught by Pratt, for the purpose of providing a suitable structure that vents the wound dressing to the atmosphere after reaching a desired negative pressure (see Pratt, paragraph 0067).
Moreover, 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 device disclosed in Freedman such that a controller is configured to receive input from the pressure sensor and to control the operation of said pump, as taught by Pratt, for the purpose of providing a suitable structure that can stop application of negative pressure once a desired negative pressure is reached (see Pratt, paragraph 0067).
Freedman does not teach an air quality sensor integrated into the wound dressing to provide physiologic parameters indicative of infection.
However, Levy teaches a wound covering apparatus (abstract) comprising an air quality sensor (1510E/1520E) integrated into the wound dressing to provide physiologic parameters indicative of infection (fig. 15, sensor 1510E or 1520E may be air quality sensors, paragraph 0122).
Therefore, 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 device disclosed in Freedman such that the system further comprises an air quality sensor integrated into the wound dressing to provide physiologic parameters indicative of infection, as taught by Levy, for the purpose of providing a suitable structure that determines if the air surrounding the wound contains harmful bacteria (see Levy, paragraph 0122).
Claims 5, 12, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Smith (US 20070118096).
Regarding claim 5, Freedman does not teach wherein said wound dressing includes at least one port for introducing moisture or an anti-infection treatment into the wound environment.
However, Smith teaches wherein the wound dressing comprises at least one port means for introducing moisture or an anti-infection treatment into the wound environment (fig. 5, fluid source 14 and humidification device 38, paragraph 0065, “The humidification device 38 may be connected to the supply line 20 to add moisture to fluid being supplied to the wound 12”, also paragraph 0075, “The humidification device 38 may also act as a drug delivery device”, thus making the humidification device 38 and the port thereof suitable for introducing anti-infection treatment).
Therefore, 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 device disclosed n Freedman such that wound dressing includes at least one port for introducing moisture or an anti-infection treatment into the wound environment, as taught by Smith, for the purpose of providing a suitable structure that allows moisture to fluid being supplied to the wound, such as oxygen (see Smith, paragraph 0074), or alternatively for allowing drugs to be delivered to the wound (see Smith, paragraph 0075).
Regarding claim 12, Freedman is silent to wherein said physiologic parameters are employed for local closed-loop control of a vacuum supply to said wound dressing.
However, Smith teaches wherein said physiologic parameters are employed for local closed-loop control of a vacuum supply to said wound dressing (paragraph 0069, “The pressure sensor 44 may be operatively connected to the controller 22 and the controller 22 may be configured to adjust the negative pressure therapy or the hyperbaric fluid therapy in response to information received from the pressure sensor 44.”. The closed loop in this scenario is the pressure sensor prompting the control means to adjust negative pressure.).
Therefore, 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 device disclosed in Freedman such that said physiologic parameters are employed for local closed-loop control of a vacuum supply to said wound dressing, as taught by Smith, for the purpose of providing a suitable structure that can adjust negative pressure therapy in response to information received from the pressure sensor (see Smith, paragraph 0069).
Regarding claim 20, Freeman is silent to wherein said sensor parameters are employed for local closed-loop control of a vacuum supply to said wound dressing.
However, Smith teaches wherein said physiologic parameters are employed for local closed-loop control of a vacuum supply to said wound dressing (paragraph 0069, “The pressure sensor 44 may be operatively connected to the controller 22 and the controller 22 may be configured to adjust the negative pressure therapy or the hyperbaric fluid therapy in response to information received from the pressure sensor 44.”. The closed loop in this scenario is the pressure sensor prompting the control means to adjust negative pressure.).
Therefore, 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 method disclosed in Freedman such that said physiologic parameters are employed for local closed-loop control of a vacuum supply to said wound dressing, as taught by Smith, for the purpose of providing a suitable structure that can adjust negative pressure therapy in response to information received from the pressure sensor (see Smith, paragraph 0069).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Long (US 20200353137, filed 01/15/2019).
Regarding claim 7, Freedman does not teach wherein the at least one humidity sensor, pressure sensor, or temperature senor determine a degree of wound hermeticity via measurements of humidity in a vacuum line.
However, Long teaches wherein the blockage/leak detection algorithm determines that if humidity data increases above a high rate, a leak alarm is sounded (paragraph 0103). The humidity sensor (418) provides a reading indicative of the humidity of the vacuum line (fig. 4, humidity sensor 418 in the path of fluid pathway 445)
Therefore, 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 device disclosed in Freedman to include a humidity sensor such that a degree of wound hermeticity is determined via measurements of humidity in a vacuum line, as suggested by Long, for the purpose of providing a suitable structure alongside a detection algorithm to determine blockages or leaks (see Long, paragraph 0103) alongside the pressure sensor in the even the pressure sensor fails to detect hermeticity.
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Robinson (US 20110245682).
Regarding claim 8, Freedman fails to teach an air sensor configured to determine a degree of wound hermeticity via measurements of local tissue oxygenation in the immediate vicinity of said wound in a patient’s skin.
However, Robinson teaches a method for locating fluid leaks (abstract) that uses a coating to detect pressure by reacting/measuring oxygen in order to detect leaks (paragraph 0048). This coating is applied on the drape (paragraph 0011), thus measuring local tissue oxygenation in the immediate vicinity of said wound in a patient’s skin. This coating is interpreted
Therefore, 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 device disclosed in Patel such that a degree of wound hermeticity is determined by measurements of local tissue oxygenation in the immediate vicinity of said wound in a patient’s skin, as taught and suggested by Robinson, for the purpose of providing a suitable structure that grants a clinician a color coded indication on leak locations (see Robinson, paragraph 0048, “In operation, the dressing coated with a pressure or temperature sensitive coating may be exposed to either oxygen rich or oxygen depleted gas to enhance the color change of the coating and locate the fluid leak source.”).
Regarding claim 18, Freedman fails to teach wherein said one or more sensors determine a degree of wound hermeticity via measurements of local tissue oxygenation in the immediate vicinity of the exit site on the patient's skin.
However, Robinson teaches a method for locating fluid leaks (abstract) that uses a coating to detect pressure by reacting/measuring oxygen in order to detect leaks (paragraph 0048). This coating is applied on the drape (paragraph 0011), thus measuring local tissue oxygenation in the immediate vicinity of said wound in a patient’s skin.
Therefore, 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 method disclosed in Freedman such that a degree of wound hermeticity is determined by measurements of local tissue oxygenation in the immediate vicinity of said wound in a patient’s skin, as taught and suggested by Robinson, for the purpose of providing a suitable structure that grants a clinician a color coded indication on leak locations (see Robinson, paragraph 0048, “In operation, the dressing coated with a pressure or temperature sensitive coating may be exposed to either oxygen rich or oxygen depleted gas to enhance the color change of the coating and locate the fluid leak source.”).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Duesterhoft (US 9084530).
Regarding claim 9, Freedman is silent to wherein said environmental conditions are communicated by wired or wireless connection to a computing or a communication device for immediate or remote monitoring.
However, Duesterhoft teaches a wound dressing in communication with a remote device, providing information associated with a wound and/or adjacent the wound dressing (col. 6, lines 29-35)
Therefore, 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 device disclosed in Freedman such that said environmental conditions are communicated by wired or wireless connection to a computing or a communication device for immediate or remote monitoring, as taught by Duesterhoft, for the purpose of providing a suitable structure that allows a caregiver to monitor a wound without directly disturbing the patient (see Duesterhoft, col. 6, lines 29-35).
Regarding claim 19, Freedman fails to teach wherein said wound conditions are communicated by wired or wireless connection to a controller, computing, or a communication device for immediate or remote monitoring.
However, Duesterhoft teaches a wound dressing in communication with a remote device, providing information associated with a wound and/or adjacent the wound dressing (col. 6, lines 29-35)
Therefore, 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 device disclosed in Freedman such that said wound conditions are communicated by wireless connection to a communication device for remote monitoring, as taught by Duesterhoft, for the purpose of providing a suitable structure that allows a caregiver to monitor a wound without directly disturbing the patient (see Duesterhoft, col. 6, lines 29-35).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Patel (US 20070055209).
Regarding claim 10, Freedman is silent to wherein the at least one sensors require an external power source.
However, Patel discloses wherein said at least one sensors require an external power source (fig. 2, pressure sensor 124 communicating with control means 126 powered by battery 122, paragraph 0031. Fig. 1 also shows the sensor 124 in wired connection), and said external power source is a battery used to supply a vacuum source (paragraph 0009, “The vacuum pump preferably includes a self-contained battery”).
Therefore, 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 device disclosed in Freedman such that the at least one sensors require an external power source, as taught by Patel, for the purpose of providing a suitable means of providing power to the sensors.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Bodecker (US 20070118038).
Regarding claim 11, Freedman fails to teach wherein said at least one sensors are passive elements which do not require an external power source.
However, Bodecker teaches a device used in a surgical procedure (abstract) that uses a passive pressure sensor absent of a battery (paragraph 0028)
Therefore, 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 device disclosed in Freedman such that the at least one sensors are passive elements which do not require an external power source, as suggested by Bodecker, for the purpose of providing a suitable structure that simplifies the assembly by removing or at least reducing the need for additional wiring for connecting to a battery.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Smith and Gadde (US 20200078499)
Regarding claim 14, Freedman, does not teach wherein the controller has a microprocessor that receives input from said at least one sensors to adjust the vacuum levels.
However, Smith teach wherein the controller receives input from said at least one sensors to adjust the vacuum levels (see Smith, paragraph 0069, “The pressure sensor 44 may be operatively connected to the controller 22 and the controller 22 may be configured to adjust the negative pressure therapy or the hyperbaric fluid therapy in response to information received from the pressure sensor 44.”),
Therefore, 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 device disclosed in Freedman such that the controller receives input from said at least one sensors to adjust the vacuum levels, as taught by Smith, for the purpose of providing a suitable structure that can adjust negative pressure therapy in response to information received from the pressure sensor (see Smith, paragraph 0069).
Freedman, as modified by Smith, is silent to wherein the controller has microprocessor.
However, Gadde teaches a negative pressure wound therapy system (abstract) that uses at least two pressure sensors (i.e., a regular sensor and a separate controller sensor), wherein the computing devices may include a conventional or proprietary microprocessor (paragraph 0282).
Therefore, 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 device disclosed in Freedman in view of Smith such that the processor is a microprocessor that receives input from said at least one sensors, as taught by Gadde, for the purpose of providing a suitable structure known in the art for processing data from sensors.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Smith, Patel, and Long.
Regarding claim 15, Freedman discloses wherein the controller controls a display screen (paragraph 0238), but fails to teach wherein the controller controls a diaphragm pump/motor assembly, a pressure sensor, and a slow-leak flow restrictor.
However, Smith teaches wherein the controller controls discloses wherein the controller (22) controls pressure sensor and the negative pressure source (paragraph 0069, wherein the controller being operatively connected to the pressure sensor is interpreted as the controller controlling the pressure sensor).
Therefore, 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 device disclosed in Freedman such that the controller controls the pressure sensor and the negative pressure source, as taught by Smith, for the purpose of providing a suitable structure that can adjust negative pressure therapy in response to information received from the pressure sensor (see Smith, paragraph 0069).
Freedman, as modified by Smith, fails to teach wherein the controller controls a motor associated with the negative pressure source.
However, Patel teaches wherein the controller controls a motor associated with the negative pressure source (paragraph 0031).
Therefore, 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 device disclosed in Freedman in view of Smith such that the controller controls a motor assembly, as taught by Patel, for the purpose of providing a known way to control the negative pressure source.
Freedman fails to teach wherein the controller controls a slow-leak flow restrictor.
However, Long teaches an air flow regulator comprising a valve controlled by a controller that allows for venting (paragraph 0092) acting as a slow-leak flow restrictor.
Therefore, 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 device disclosed in Patel such that the controller controls a slow-leak flow restrictor, as taught by Long, for the purpose of providing a suitable structure that allows airflow venting (see Long, paragraph 0092).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Freedman in view of McCarthy, Russo, Cartmell, and Pratt, and further in view of Long and Levy.
Regarding claim 17, Freedman discloses wherein one or more sensors determine said degree of wound healing via measurements of pressure (paragraph 0064 describes a wound pressure sensor providing measurement of therapeutic negative pressure reaching the wound surface), but fails to teach wherein said one or more sensor determine said degree of wound healing via measurements of humidity, temperature, air quality, and pressure in a vacuum line to said wound dressing.
However, Patel teaches wherein one or more sensor determine a degree of wound healing via measurements of temperature (paragraph 0039, “The presence of an elevated temperature may be indicative of an infection”).
Therefore, 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 device disclosed in Freedman by adding a temperature sensor such that a degree of wound healing is determined via measurements of temperature, as taught by Patel, for the purpose of providing a suitable structure that can detect potential infection (see Patel, paragraph 0039).
Freedman fails to teach wherein the wound healing is determined via measurements of temperature, humidity and air quality in a vacuum line to said wound dressing.
However, Long teaches wherein the blockage/leak detection algorithm determines that if humidity data increases above a high rate, a leak alarm is sounded (paragraph 0103). The humidity sensor (418) provides a reading indicative of the humidify of the vacuum line (fig. 4, humidity sensor 418 in the path of fluid pathway 445).
Moreover, Levy teaches a wound covering apparatus (abstract) comprising an air quality sensor (1510E/1520E) integrated into the wound dressing to provide physiologic parameters indicative of infection (fig. 15, sensor 1510E or 1520E may be air quality sensors, paragraph 0122).
Therefore, 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 method disclosed in Freedman such that a degree of wound healing is additionally determined by measurements of humidity (taught by Long) and air quality (taught by Levy), for the purpose of providing a suitable method that grants additional and alternative ways to determine a leak or blockage (see Long, paragraph 0103) and infection (see Levy, paragraph 0122) in the event that the pressure and temperature sensors do not detect these conditions, thus improving the accuracy of the system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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 Eisenberg can be reached on 5712705879. 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.
/Brandon W. Levy/Examiner, Art Unit 3781