DETAILED ACTION
This Office Action is responsive to the Amendment filed 15 October 2025. Claims 1 - 16 are now pending. The Examiner acknowledges the amendments to claims 10 and 12.
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 .
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.
Claims 1 – 7, 9, 13 and 15 - 16 are rejected under 35 U.S.C. 103 as being unpatentable over Teodorescu et al (WO 2018014003 A1, hereinafter Teodorescu) in view of Cheatham et al (US 20160331461 A1, hereinafter Cheatham) in further view of Forsell (WO 2013012368 A1).
Regarding claim 1, Teodorescu teaches an enclosure system ( “a portable surgical system”, abstract, page 2, lines 37 - 40) comprising:
one or more enclosure walls comprising flexible walls and at least one transparent section (“transparent and flexible plastic enclosure”, abstract; “transparent soft plastic enclosure”, page 2, line 39; Figures 1 - 2), the one or more enclosure walls being walls of an enclosure (“enclosure 1”, page 6, line 158; Figures 1 - 2);
an air vent having a variable pneumatic resistance (“The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329); and
a control system (“air supply system”, page 4, line 110, page 11, lines 320 – 324, Figure 11) configured to control an environment within the enclosure (1) (“The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 - 329), the control system (“air supply system”, page 4, line 110, page 11, lines 320 – 324, Figure 11) comprising:
an air source (“fan (blower with motor) 21”, page 11, line 322, Figure 11) configured to provide air within the enclosure (1) (“The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Figure 11; Examiner interprets since the “fan (blower with motor 21)” is part of the air supply system, the “fan (blower with motor 21” is configured to provide air within the enclosure. Figures 1 - 2 );
one or more sensors comprising at least one of pressure sensors, differential pressure sensors, airflow sensors, or wall straightness sensors, the one or more sensors coupled to the one or more enclosure walls and (“The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Figure 11; ; Examiner interprets the ”inlet, valve, and manifold system integrated into the enclosure” reads on parts of a wall. The state of the wall is either releasing air or retaining air. When air is released, the pressure inside is a predetermined amount higher than the pressure outside, hence this constitutes a measurement.)
configured to obtain wall state data indicative of a straightness level of the one or more enclosure walls and (“This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation.”, page 18, lines 522 – 526; Examiner interprets if no air is released, hence the tube valve or sensor is obtaining data about the valve wall state.)
an inflation level of the enclosure (“This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation.”, page 18, lines 522 – 526; “Inlet tube valve inflation is utilized as the indicator of adequate airflow through the environmental system. The first inflation is thus also an initial purge of any contamination introduced during that step. When the system is adequately inflated, or an indicator is activated, the environmental system is switched to maintenance mode 55.”page 18, line 544 – page 19, lines 545 – 547; Examiner interprets the inflation level is directly dependent on the pressure maintained by the tubevalve.),
a processor (processor in the “air supply system”, page 18, line 518) configured to:
receive pressure data, differential pressure data, and the wall state data from the one or more sensors (“This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation.”, page 18, lines 522 – 526; “Inlet tube valve inflation is utilized as the indicator of adequate airflow through the environmental system. The first inflation is thus also an initial purge of any contamination introduced during that step. When the system is adequately inflated, or an indicator is activated, the environmental system is switched to maintenance mode 55.”page 18, line 544 – page 19, lines 545 – 547);
determine the inflation level of the enclosure based on the wall state data (“This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation.”, page 18, lines 522 – 526; “Inlet tube valve inflation is utilized as the indicator of adequate airflow through the environmental system. The first inflation is thus also an initial purge of any contamination introduced during that step. When the system is adequately inflated, or an indicator is activated, the environmental system is switched to maintenance mode 55.”page 18, line 544 – page 19, lines 545 – 547 );
control an airflow provided by the air source into the enclosure (fan (blower with motor) 21”, page 11, line 322, Figure 11 ) and through the air vent (“The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329 ) (page 2, lines 47 – 48; page 18, lines 518 – 527; page 11, line 326 – 329);
control a pressure inside the enclosure and the airflow into the enclosure, wherein a state of the inside the enclosure is maintained by continuous flow of air provided by the air source (“The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329).
Teodorescu does not teach the straightness level of the one or more enclosure walls satisfies a straightness threshold of the enclosure.
However, Cheatham discloses “an interactive surgical drape and system including at least one sensor and at least one controller that operates indicating sensing feedback from the at least one sensor to cause display of information on a dynamic display integrated with the interactive surgical drape” (abstract) and teaches a straightness level of the one or more enclosure walls satisfies a straightness threshold of an enclosure ([0030], [0036] – [0037], [0056] – [0060], Figures 3 – 5; Examiner interprets the straightness of a surgical enclosure wall is automatically measured, displayed and fed back to the control system.). 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 enclosure system of Teodorescu such that the straightness level of the one or more enclosure walls satisfies a straightness threshold of the enclosure, as taught by Cheatham, for the benefit of maintaining a “sterile field particular to a given procedure” (Teodorescu: page 2, line 46) and ensuring the enclosure walls maintain turgidity.
The modified invention of Teodorescu and Cheatham does not teach determining the differential pressure data, wherein the differential pressure data reflects a differential pressure between inside the enclosure and outside the enclosure.
However, Forsell discloses an invention relating “to the field of endoscopic and/or open surgery” ([0001]) and teaches determining the differential pressure data, wherein the differential pressure data reflects a differential pressure between inside the enclosure and outside the enclosure (“adjusting the pressure in the pressure sealing member as a response to: the pressure in the chamber and the pressure in the pressure sealing member”, [000331]; Examiner interprets the Forsell’s processor would determine the differential pressure between the chamber and sealing member in order to adjust the pressure). 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 enclosure system of Teodorescu and Cheatham to incorporate determining the differential pressure data, wherein the differential pressure data reflects a differential pressure between inside the enclosure and outside the enclosure, as taught by Forsell, for the benefit of maintaining a “sterile field particular to a given procedure” (Teodorescu: page 2, line 46) and ensuring the enclosure walls maintain turgidity.
Regarding claim 2, Teodorescu, Cheatham and Forsell teach all limitations of claim 1. The modified invention of Teodorescu, Cheatham and Forsell teaches the processor is further configured to:
analyze and predict a change of the differential pressure data over a set time, and a change of the wall state data over a set time (Forsell: [000331]); and
control the pressure inside the enclosure and the airflow into the enclosure such that the pressure inside the enclosure remains in a predetermined pressure range (Forsell: [000331]) and the straightness level of the one or more enclosure walls is above a minimum straightness threshold ([0030], [0036] – [0037], [0056] – [0060], Figures 3 – 5; Examiner interprets the straightness of a surgical enclosure wall is automatically measured, displayed and fed back to the control system.).
The modified invention of Teodorescu, Cheatham and Forsell does not explicitly teach a maximum value of the pressure inside the enclosure is less than a pressure level associated with a patient safety threshold limit.
However, Forsell discloses and teaches teach a maximum value of the pressure inside the enclosure is less than a pressure level associated with a patient safety threshold limit (Forsell: [000331] – [000332]). 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 enclosure system of Teodorescu, Cheatham and Forsell to incorporate a maximum value of the pressure inside the enclosure is less than a pressure level associated with a patient safety threshold limit, as taught by Forsell, for the benefit of protecting user/patient from being harmed.
Regarding claim 3, Teodorescu, Cheatham and Forsell teach all limitations of claim 2. The modified invention of Teodorescu, Cheatham and Forsell teaches at least one of the differential pressure sensors (i) (Teodorescu: “The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Figure 11; Examiner interprets the ”inlet, valve, and manifold system integrated into the enclosure” reads on parts of a wall. ).
The modified invention of Teodorescu, Cheatham and Forsell does not teach the at least one of the differential pressure sensors (i) is attached to one or more enclosure walls and is coupled to a first measuring surface disposed inside the enclosure and a second measuring surface disposed outside the enclosure to measure a difference between an ambient pressure and an internal pressure; and/or
(ii) is placed external to the said enclosure and is coupled to pressure tubes penetrating the one or more enclosure walls such that a differential pressure measurement is made possible.
However, Forsell discloses a “surgical method to be performed on the body of a patient using an interconnectable port” (abstract) and teaches pressure sensors (“pressure sensor”, [000489]) (i) is attached to one or more enclosure walls (“monitoring probe 1973 comprises a pressure sensor adapted to detect change in the pressure in the sealing 1905", [000489], Figure 209a) and is coupled to a first measuring surface disposed inside the enclosure and a second measuring surface disposed outside the enclosure to measure a difference between an ambient pressure and an internal pressure; and/or
(ii) is placed external to the said enclosure ([000488 - 000494], Figures 209a – 209c) and is coupled to pressure tubes penetrating the one or more enclosure walls such that a differential pressure measurement is made possible.
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 enclosure system of Teodorescu, Cheatham and Forsell such that the at least one of the differential pressure sensors (i) is attached to one or more enclosure walls and is coupled to a first measuring surface disposed inside the enclosure and a second measuring surface disposed outside the enclosure to measure a difference between an ambient pressure and an internal pressure; and/or (ii) is placed external to the said enclosure and is coupled to pressure tubes penetrating the one or more enclosure walls such that a differential pressure measurement is made possible, as taught by Forsell 368’, for the benefit of “reduc[ing] the risk of contaminating the incision sites, as the constant overpressure will make it close to impossible for any particles to enter the sealed chamber”/enclosure (Forsell 368’: [000509]).
Regarding claim 4, Teodorescu, Cheatham and Forsell teach all limitations of claim 2. The modified invention of Teodorescu, Cheatham and Forsell teaches the airflow sensors (Teodorescu: “The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Figure 11; Examiner interprets the ”inlet, valve, and manifold system integrated into the enclosure” reads on parts of a wall.) are configured to detect airflow through one or more portions of the enclosure (Teodorescu: “The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Figure 11; ; Examiner interprets the ”inlet, valve, and manifold system integrated into the enclosure” reads on parts of a wall. The state of the wall is either releasing air or retaining air. When air is released, the pressure inside is a predetermined amount higher than the pressure outside, hence this constitutes a measurement.); and
the processor is configured to control the pressure inside the enclosure and the airflow into the enclosure such that the pressure inside the enclosure is in the predetermined pressure range (Teodorescu: “The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Figure 11; ; Examiner interprets the ”inlet, valve, and manifold system integrated into the enclosure” reads on parts of a wall. The state of the wall is either releasing air or retaining air. When air is released, the pressure inside is a predetermined amount higher than the pressure outside, hence this constitutes a measurement.), and the airflow into the enclosure is within a particular airflow range (Teodorescu: page 2, lines 47 – 48; page 18, lines 518 – 527; page 11, line 326 – 329, Figure 11).
The modified invention of Teodorescu, Cheatham and Forsell does not teach the processor is configured to control the straightness level of the one or more enclosure walls is above the minimum straightness threshold.
However, Cheatham discloses “an interactive surgical drape and system including at least one sensor and at least one controller that operates indicating sensing feedback from the at least one sensor to cause display of information on a dynamic display integrated with the interactive surgical drape” (abstract) and teaches a processor is configured to control a straightness level of the one or more enclosure walls is above the minimum straightness threshold ([0030], [0036] – [0037], [0056] – [0060], Figures 3 – 5; Examiner interprets the straightness of a surgical enclosure wall is automatically measured, displayed and fed back to the control system.). 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 enclosure system of Teodorescu, Cheatham and Forsell such that the processor is configured to control the straightness level of the one or more enclosure walls is above the minimum straightness threshold, as taught by Cheatham, for the benefit of maintaining a “sterile field particular to a given procedure” (Teodorescu: page 2, line 46) and ensuring the enclosure walls maintain turgidity.
Regarding claim 5, Teodorescu, Cheatham and Forsell teach all limitations of claim 1. The modified invention of Teodorescu, Cheatham and Forsell teaches at least one of the sensors (Teodorescu: “The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48; “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Figure 11; ; Examiner interprets the ”inlet, valve, and manifold system integrated into the enclosure” reads on parts of a wall. The state of the wall is either releasing air or retaining air. When air is released, the pressure inside is a predetermined amount higher than the pressure outside, hence this constitutes a measurement.) is coupled to a portion of the one or more enclosure walls (Teodorescu: Figure 11) and comprises:
a flexible foil (Teodorescu: “flexible plastic enclosure 1”, abstract, page 6, line 158 and “walls of flexible, collapsible plastic such as polyethylene”, page 6, lines 163 - 164, Figures 1 - 2) mechanically connected to a portion of an enclosure wall of the one or more enclosure walls (Teodorescu: Figures 1 - 2); and
a pressure sensing device (Teodorescu: “The flexible tube may be a collapsible tube that opens when air is blown into the enclosure and closes when air moves out of the enclosure such that transmural pressure from the enclosure favors tube collapse.”, page 12, lines 355 - 358) disposed between the portion of the enclosure wall and the flexible foil (Teodorescu: 602) (Teodorescu: Figure 1),
wherein the flexible foil (Teodorescu: “flexible plastic enclosure 1”, abstract, page 6, line 158 and “walls of flexible, collapsible plastic such as polyethylene”, page 6, lines 163 - 164) is configured to apply a compression force on the pressure sensing device when the enclosure wall is straightened (Teodorescu: Figure 11); and
wherein the pressure sensing device (Teodorescu: page 12, lines 355 – 358) is configured to measure a pressure between a surface of the enclosure and a surface of the flexible foil (Teodorescu: “flexible plastic enclosure 1”, abstract, page 6, line 158 and “walls of flexible, collapsible plastic such as polyethylene”, page 6, lines 163 - 164) (“The flexible tube may be a collapsible tube that opens when air is blown into the enclosure and closes when air moves out of the enclosure such that transmural pressure from the enclosure favors tube collapse.”, page 12, lines 355 - 358);
wherein the processor (processor in the “air supply system”, page 18, line 518) is configured to receive the wall state data from the pressure sensing device (“flexible tube”, page 12, lines 355 - 358) and to determine the inflation level of the enclosure based on the wall state data (Teodorescu: “The flexible tube 2 may include a plurality of perforations 3 acting as manifold. The flexible tube may run side to side or along the enclosure. The flexible tube may be formed by sealing a fold of the enclosure into a tubular structure. The flexible tube may be a collapsible tube that opens when air is blown into the enclosure and closes when air moves out of the enclosure such that transmural pressure from the enclosure favors tube collapse.” page 12, lines 355 – 358; page 18, lines 522 – 526; page 18, line 544 – page 19, lines 545 – 547 ).
The modified invention of Teodorescu, Cheatham and Forsell does not teach a straightness wall sensor.
However, Cheatham discloses “an interactive surgical drape and system including at least one sensor and at least one controller that operates indicating sensing feedback from the at least one sensor to cause display of information on a dynamic display integrated with the interactive surgical drape” (abstract) and teaches a straightness wall sensor ([0030], [0036] – [0037], [0056] – [0060], Figures 3 – 5). 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 enclosure system of Teodorescu, Cheatham and Forsell to incorporate a straightness sensor, as taught by Cheatham, for the benefit of maintaining a “sterile field particular to a given procedure” (Teodorescu: page 2, line 46) and ensuring the enclosure walls maintain turgidity.
Regarding claim 6, Teodorescu, Cheatham and Forsell teach all limitations of claim 5. The modified invention of Teodorescu, Cheatham and Forsell teaches at least one of the wall straightness sensors (Cheatham: [0030], [0036] – [0037], [0056] – [0060], Figures 3 – 5) comprises one or more of:
a piezoelectric device (Cheatham: “piezoelectric sensor”, [0036], Examiner interprets the displacement of the drape, i.e. the flexible wall, piezoelectric sensors or strain gauge sensors can be used.); or
a capacitive sensor (Cheatham: “capacitive sensor”, [0036]) configured to determine a pressure force applied to the pressure sensing device based on a change in a spacing between capacitor plates of the capacitive sensor (Cheatham: “capacitive sensor”, [0036]).
Regarding claim 7, Teodorescu, Cheatham and Forsell teach all limitations of claim 1. The modified invention of Teodorescu, Cheatham and Forsell teaches at least one of the wall straightness sensors (Cheatham: [0030], [0036] – [0037], [0056] – [0060], Figures 3 – 5) comprises one or more of the following:
a strain gauge connected to an inner surface or an outer surface of the enclosure and configured to deform together with the one or more enclosure walls;
an interdigital capacitor coupled to the one or more enclosure walls, the interdigital capacitor being configured to deform together with the one or more enclosure walls, the deformation of the interdigital capacitor corresponding to a change in a capacitance of the interdigital capacitor; and
a camera configured to obtain an image of an enclosure wall of the one or more enclosure walls, to provide the image to the processor for determining the straightness level based on the image (Cheatham: “sensing means includes at least one remote sensor, such as a camera or other imaging sensor. For example, a camera capable of imaging the disposition of the interactive surgical drape device itself can provide information to the processor and controller”, [0030]).
Regarding claim 9, Teodorescu, Cheatham and Forsell teach all limitations of claim 4. The modified invention of Teodorescu, Cheatham and Forsell teaches the air source (Teodorescu: “fan (blower with motor) 21”, page 11, line 322, Figure 11) further comprises:
an air source case (Teodorescu: 21 casing in Figure 11) comprising:
an air pump configured to generate the airflow (Teodorescu: “blower with motor 21”, page 11, line 322); and
a filter coupled to the air pump (Teodorescu: “HEPA filter 19”, page 11, line 322) and configured to filter the airflow generated by the air pump (Teodorescu: “filtered air”, page 6, line 162); and
an air duct (Teodorescu: see annotated Teodorescu’s Figure 11) connecting the air source case (Teodorescu: 21 casing in Figure 11) to the enclosure (“enclosure 1”, page 6, line 158; Figures 1 – 2) and configured to provide filtered air from the air source (Teodorescu: Figure 11) to the enclosure (Teodorescu: [00167], Figure 12A), the air duct (Teodorescu: 1208) comprising one or more of:
at least one end detachable from the enclosure or from the air source case (Teodorescu: ” turn off the environmental control system, remove the air supply tubing from the air handling inlet, pull the enclosure off of the frame as well as off of the patient, and dispose of the enclosure.”, Examiner interprets the parts of the “air supply” system is detachable, considering Teodorescu is a “portable surgical system” (Teodorescu: page 11, line 320) and “The HEPA filter immediately downstream of air inflow may be changeable and 330 customizable such that it provides one or more other controls based on procedural need, such as humidity modulator filter, gas content with supply of medical gases, or temperature modulator with heat/cold sinks.” (Teodorescu: page 11, lines 329 - 332). .);
a pressure sampling tube configured to detect a pressure level in the air duct (Teodorescu: “an inflow tube valve 2”, page 18, line 518) (Teodorescu: “This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation.”, page 18, lines 518 - 525);
a section extending outside the enclosure (Teodorescu: see annotated Teodorescu’s Figure 11);
one or more sections inside the enclosure (Teodorescu: see annotated Teodorescu’s Figure 11); and
one or more valves for preventing backflow into the air source case (Teodorescu: 21 casing in Figure 11) (Teodorescu: “If the environmental control system 5 is shut off, the flexible overhead tube 2 is pinched shut, thus sealing the enclosure 1 and preventing backflow into the fan and filter 5.”, page 6, lines 177 – 180; “This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation.”, page 18, lines 518 – 525).
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Regarding claim 13, Teodorescu, Cheatham and Forsell teach all limitations of claim 1. The modified invention of Teodorescu, Cheatham and Forsell teaches the air vent (Teodorescu: “The enclosure may be filled with air from the environmental control system through an inlet, valve, and manifold system integrated into the enclosure.”, page 2, lines 47 – 48) is partially open to permit the air to be continually circulated throughout the enclosure (Teodorescu: “When there is net positive airflow through the tube toward the manifold in this configuration, the transmural 520 pressure is positive relative to the enclosure, and the tube is forced open. When there is no airflow or reversed airflow, the transmural pressure drops relative to the enclosure, causing longitudinal collapse of the tube. This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation. The airflow then proceeds to a manifold 3, implemented as above in the horizontal manifold system.”, page 18, lines 518 – 527; “The air supply system may be connected to the flexible overhead tube 2 of the surgical enclosure with flexible tubing so that the inlet height of the overhead airflow tube 2 can adjust based on the level of inflation of the enclosure 1.”, page 11, line 326 – 329, Examiner interprets net positive airflow allows continuous airflow.).
Regarding claim 15, Teodorescu, Cheatham and Forsell teach all limitations of claim 1. The modified invention of Teodorescu, Cheatham and Forsell teaches the processor (Teodorescu: processor in the “air supply system”, page 18, line 518) is configured to determine a status of the enclosure system (Teodorescu: “This tube valve reduces further flow in the setting of enclosure excess pressurization as the enclosure positive pressure produces transmural pressure favoring valve collapses; prevents flow reversal as enclosure positive pressure seals off air outflow 525 through the valve; and also serves as an indicator of adequate airflow indicator by virtue of its inflation.”, page 18, lines 518 - 525).
The modified invention of Teodorescu, Cheatham and Forsell does not teach generating an alarm signal in response to determining that the status of the enclosure system is indicative of:
a contamination threat to the enclosure,
an abnormal pressure through the enclosure, or
an abnormal airflow through the enclosure.
However, Cheatham discloses “an interactive surgical drape and system including at least one sensor and at least one controller that operates indicating sensing feedback from the at least one sensor to cause display of information on a dynamic display integrated with the interactive surgical drape” (abstract) and teaches generating an alarm signal in response to determining that the status of the enclosure system is indicative of a contamination threat to the enclosure (Cheatham: “detected by the sensor assembly, such as vital signs, ECG tracings, blood oxygenation levels, blood chemistries, blood loss, and the like. For example, the dynamic display can display an alert regarding at least one physiological characteristic of a specific body part, e.g., detected edema in a limb, apnea while under anesthesia, heart afibrillar beating, blood pressure changes”, [0035], Examiner interprets an alert is triggered depending on physiological characteristics of a body part, e.g. blood loss in which is an contamination event; “… to provide at least one of an auditory alert, a visual alert, or a tactile alert based on the at least one sensed signal indicative of detection of … a change in the disposition of the interactive surgical drape”, [0101]), an abnormal pressure through the enclosure, or an abnormal airflow through the enclosure. 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 enclosure system of Teodorescu, Cheatham and Forsell to incorporate generating an alarm signal in response to determining that the status of the enclosure system is indicative of a contamination threat to the enclosure, as taught by Cheatham, for the benefit of “improv[ing] the efficiency and/or effectiveness of the surgical team” (Cheatham: abstract).
Regarding claim 16, Teodorescu, Cheatham and Forsell teach all limitations of claim 1. The modified invention of Teodorescu, Cheatham and Forsell teaches the enclosure system (Teodorescu: “a portable surgical system”, abstract, page 2, lines 37 - 40).
The modified invention of Teodorescu, Cheatham and Forsell does not teach the enclosure system further comprising one or more strip antennas, wherein the one or more strip antennas are configured to wirelessly transmit or receive data from the one or more strip antennas to the processor.
However, Cheatham discloses “an interactive surgical drape and system including at least one sensor and at least one controller that operates indicating sensing feedback from the at least one sensor to cause display of information on a dynamic display integrated with the interactive surgical drape” (abstract) and an enclosure system (“interactive surgical drape device and system”, [0006], [0017]) further comprising one or more strip antennas (Cheatham: ”In an embodiment, the interactive surgical drape device or system includes at least one sensor in the form of a sensor assembly; and at least one transmitter; receiver; transceiver; Bluetooth™; GPS (global positioning system); or output or input components.”, [0007]; [0027]; “the interactive surgical drape includes at least one of a wired or wireless avenue for communication between the sensor assembly”, [0048], [0074], ” a processor of the system 200 is operably coupled, via wire or wirelessly, to the interactive surgical drape 205”, [0107]; Examiner interprets the Bluetooth and wifi- receiver/wireless communication includes at least one strip antenna.) disposed on the one or more enclosure walls (Cheatham: “the interactive surgical drape includes at least one of a wired or wireless avenue for communication between the sensor assembly”, [0048]; “the sensor assembly, circuitry, or dynamic display includes electronics embedded in or in contact with the surgical drape”, [0032], Figure 7),
wherein the one or more strip antennas are configured to wirelessly transmit or receive data from the one or more strip antennas to the processor (Cheatham: “information is communicated from the at least one sensor to the processor, the controller, and optionally subsequently to the dynamic display by way of a wireless device.”, [0028]).
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 enclosure system of Teodorescu, Cheatham and Forsell such that teach the enclosure system further comprising one or more strip antennas, wherein the one or more strip antennas are configured to wirelessly transmit or receive data from the one or more strip antennas to the processor, as taught by Cheatham, for the benefit of “display[ing] […] for more efficient, safer, and more effective surgical procedures” (Cheatham: [0026]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Teodorescu, Cheatham and Forsell, as applied in claim 1, in view of Laby (US 20180085559 A1).
Regarding claim 8, Teodorescu, Cheatham and Forsell teach all limitations of claim 1. The modified invention of Teodorescu, Cheatham and Forsell teaches “the sensor assembly, circuitry, or dynamic display includes electronics embedded in or in contact with the surgical drape” (Cheatham: [0027], Examiner interprets the optical fiber is part of the sensor and thus, reads on the limitation “the optical fiber is attached to the one or more enclosure walls”.) but does not teach at least one of the wall straightness sensors comprises an optical fiber, a light source, and a fiber detector, wherein the optical fiber is configured to deform together with the one or more enclosure walls, the deformation of the optical fiber corresponding to a change in a signal detected by the fiber detector.
However, Laby discloses “[a]rticulation devices, systems, methods for articulation, and methods for fabricating articulation structures” (abstract) and teaches at least one of the wall straightness sensors comprises an optical fiber, a light source, and a fiber detector (“optical fiber shape sensors (such as those using fiber Bragg gratings)”, [0243]),
and configured to deform together with the one or more enclosure walls (“catheter bend monitoring techniques (such as optical fiber systems or the like)”, [0057]), the deformation of the optical fiber corresponding to a change in a signal detected by the fiber detector (“from known catheter bend monitoring techniques (such as optical fiber systems or the like). Processors of some embodiments may employ any of these or other sensors for feedback on the actual location, orientation, movement and/or pose and for determining further valve actuation signals”, [0057]; Examiner interprets an optical fiber system includes fiber detector). 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 enclosure system of Teodorescu, Cheatham and Forsell to incorporate at least one of the wall straightness sensors comprises an optical fiber, a light source, and a fiber detector, wherein the optical fiber is configured to deform together with the one or more enclosure walls, the deformation of the optical fiber corresponding to a change in a signal detected by the fiber detector, as taught by Laby, for the benefit of determining the enclosure’s straightness and provide enough space for users during operation.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Teodorescu, Cheatham and Forsell, as applied in claim 9, in view of Right et al (US 20050030172 A1, hereinafter Right).
Regarding claim 10, Teodorescu, Cheatham and Forsell teach all limitations of claim 9. The modified invention of Teodorescu, Cheatham and Forsell teaches an airflow (Teodorescu: “filtered air”, page 6, line 162) generated by an air pump (Teodorescu: “blower with motor 21”, page 11, line 322) but does not teach the air source case further comprises:
one or more airflow separators disposed in proximity of the filter and configured to separate the airflow generated by the air pump;
one or more filter sensors configured to detect at least one of an airflow, a pressure, or both over individual filter areas; and
differences between the airflow, the pressure, or both over adjacent filter areas,
wherein the processor is configured to receive filter sensor data from the one or more filter sensors, to determine a filter status, and to generate a message indicative of the filter status, and display a message indicative of the filter status.
However, Right discloses “a device and method for detecting changes in ambient air conditions” (abstract) and teaches an air source case (“A device for monitoring changes in airflow rates through detector dust filters”, abstract) further comprises:
one or more airflow separators disposed in proximity of a filter (“filter 30”, [002