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
The amendments under 37 CFR 1.132 filed 04/24/2026 is sufficient to overcome the rejection of independent claim 1 based upon being rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and further in view of Aguayo (US 5283943 A).
Acknowledgement is made to newly added claim 70. Currently claims 1-3, 9-19, 21-22, 32-33, 35, and 70 are pending in the application.
Response to Arguments
Applicant’s arguments, see Remarks, filed 04/24/2026, with respect to the rejection(s) of claim(s) 1-3, 10-12, 19, 33, 35, and 38 rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and further in view of Aguayo (US 5283943 A) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made further in view of Seaman (US 20090198365 A1).
Applicant further argues that Bonczar's user interfaces (See Bonczar at FIGS. 4, 5, 6, 7, cited by the Examiner during the interview), merely show "information that may appear on a user interface screen of an extracorporeal life support system during preparation and pre-testing of the system," (Bonczar at para. 0078; see also paras. 0079-0086), not "a series of instructions for interfacing portions of the heat exchange fluid loop with corresponding portions of the control console," as recited by amended claim 1. Nor does Bonczar describe "a corresponding indicator of a set of indicators located on the heat exchange fluid loop in the order, the matching being at positions for guiding the setting of the heat exchange fluid loop in the control console in accordance with the order instructed in the series of instructions," as recited in amended claim 1. Examiner agrees that Bonczar fails to teach the amended portion of claim 1 and therefore withdraws the rejection.
However, Bonczar teaches a series of preparation tests displayed on the user interface screen. The tests are in preparation for the system to run as intended ([0077] FIGS. 4 through 9 are screen shots showing examples of information that may appear on the screen of the user interface 24 during preparation and pre-testing of the ECLS device 12).
Dabrowiak teaches a graphical interface comprising a series of instructions for interfacing portions of the heat exchange fluid loop ([0046] the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system) ([0044] the controller 36 may prompt the user to select, via user interface 104) with corresponding portions of the control console and set up the heat exchange fluid loop ([0046] the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system) ([0044] the controller 36 may prompt the user to select, via user interface 104).
Aguayo teaches set up in an order by matching indicators that specify the order and are represented in each instruction of the series of instructions of setup steps with a corresponding indicator of a set of indicators located on the heat exchange fluid loop in the order, the matching indicators being at positions for guiding the setting of the heat exchange fluid loop in the control console ([6] The position indicator 102 may be any indication that informs the machine operator of the correct location of identified components. The indication may be visible, audible or detectable by any human or artificial means. In a simple configuration, the position indicator 102 may inform the machine operator of a symbol (number, letter or otherwise) that is indicative of a location. For example, FIG. 1 shows locations 107 labeled as A, B, C and D. If an identified device belongs in location D, the position indicator 102 points to letter D. A more useful configuration employs a visual indication at the site of the location. For example, if after identification the invention determines that components belong in location D, then a blinking light adjacent location D would guide the machine operator to properly place the components).
Further, Seaman teaches set up in an order by matching indicators that specify the order ([0037] the assembly manager 102 may require the human assembler 106 to complete required assembly steps 105 in the proper manner and order before proceeding to a subsequent assembly step. The assembly sequence 104, in some embodiments, may require proper orientation of a single component rather than attachment to another component to complete the assembly sequence 104).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 10-12, 19, 33, 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and further in view of Aguayo (US 5283943 A) and Seaman (US 20090198365 A1).
Regarding claim 1, Dabrowiak teaches an improved temperature management system for ease and timing of setup by a user comprising: a heat exchange fluid loop (Fig 7; console 92 capable of controlling a body surface heat exchange device 46); a control console (Fig 7; console 92) comprising: a heat exchange bath (Fig 7; In the console 92 depicted in this example, the circulating heat exchange fluid is warmed or cooled by a circulation coil 98 or other heat exchanger that is submersed within a well 96 that contains warmed or cooled fluid) configured to receive at least a portion of the heat exchange fluid loop (Fig 7; console 92 capable of controlling a body surface heat exchange device 46) in a heat exchange cavity (Fig 7; circulation coil 98 or other heat exchanger that is submersed within a well 96) and couple with a bath cap to close off the heat exchange cavity (Fig 7; heat exchange bath 96 located within console 92 which is covered as shown in Fig 1); a pump (Fig 7; a pump 110) comprising: a rotor; a set of rollers that extend from the rotor ([0050] the raceway and tubing embodiments described above may be used with a pump having one or more rotors with rollers, and having symmetrical or nonsymmetrical rollers); an arcuate raceway that extends around the set of rollers ([0050] The raceway and tubing embodiments described above may be used with a pump having one or more rotors with rollers), wherein the raceway is configured to receive a pump tube of the heat exchange fluid loop ([0049] In FIG. 8C, two tubes, tubing 78 and 79, are positioned within a single raceway); an air trap (Fig 7; air trap 108) coupled to the heat exchange fluid loop (Fig 7; air-trap 108 connected to fluid lines) and configured to couple with the control console ([0046] the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system. Alternately the system may self-prime during the normal course of use. If the optional air-trap 108 is used) and a graphical interface comprising a series of instructions for interfacing portions of the heat exchange fluid loop ([0046] the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system) ([0044] the controller 36 may prompt the user to select, via user interface 104) with corresponding portions of the control console and set up the heat exchange fluid loop ([0046] the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system) ([0044] the controller 36 may prompt the user to select, via user interface 104); installation of the at least a portion of the heat exchange fluid loop (Fig 7; console 92 capable of controlling a body surface heat exchange device 46) in the heat exchange cavity of the heat exchange bath (Fig 7; In the console 92 depicted in this example, the circulating heat exchange fluid is warmed or cooled by a circulation coil 98 or other heat exchanger that is submersed within a well 96 that contains warmed or cooled fluid) and closing of the heat exchange cavity (Fig 7; heat exchange bath 96 located within console 92 which is covered as shown in Fig 1), placement of the air trap into the air trap holder in the first orientation that is ready for priming the heat exchange fluid loop ([0046] In some embodiments, before commencing the selected mode of heat exchange, the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system. Alternately the system may self-prime during the normal course of use. If the optional air-trap 108 is used, this is unlikely to be feasible), and installation of the pump tube loop ([0049] In FIG. 8C, two tubes, tubing 78 and 79, are positioned within a single raceway) by operation of the pump knob.
Dabrowiak fails to fully teach a pump knob configured to be receivable in a user's hand and allow for ease of grip and rotation of the pump knob by the user, the pump knob configured to orient the rollers to enable loading and unloading of the tube; an air trap coupled to the fluid loop and configured to couple with the control console via an air trap holder in a first orientation during priming of the heat exchange fluid loop and couple with the control console via an air trap receptacle in a second orientation during operation of the temperature management system; in an order by matching indicators that specify the order and are represented in each instruction of the series of instructions of setup steps with a corresponding indicator of a set of indicators located on the heat exchange fluid loop in the order, the matching being at positions for guiding the setting of the heat exchange fluid loop in the control console in accordance with the series of instructions, and installation of the pump tube loop by operation of the pump knob to advance the pump tube into the pump in a direction indicated by an instruction of the series of instructions.
However, Hendricks teaches a pump knob configured to be receivable in a user's hand and allow for ease of grip and rotation of the pump knob by the user (Fig 6; handle 70), the pump knob configured to orient the rollers to enable loading and unloading of the tube ([0030] A handle 70 is coupled at a hinge mechanism 72 to the push rod 64. The handle can be moved by hand to a substantially perpendicular orientation relative to the push rod 64 (FIGS. 6 and 9) to pull the push rod and thus to move the motor mount 56 (and hence rotor 34) toward the inner surface of the raceway 32, thereby moving the rotor 34 to the pump position) and installation of the pump tube loop by operation of the pump knob ([0030]) to advance the pump tube into the pump in a direction indicated by an instruction of the series of instructions ([0030] The handle can also be moved by hand down from the perpendicular orientation to the non-perpendicular orientation shown in FIGS. 7 and 8. This pushes the push rod 64 and thus moves the motor mount 56/rotor 34 away from the pump position to the tube load position) ([0030] A positioning mechanism is coupled to the motor mount 56 and is manipulable by a person to move the motor mount 56 to thereby move the rotor 34 between the pump position and the tube load position). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include a pump knob configured to be receivable in a user's hand and allow for ease of grip and rotation of the pump knob by the user, the pump knob configured to orient the rollers to enable loading and unloading of the tube, and installation of the pump tube loop by operation of the pump knob to advance the pump tube into the pump in a direction indicated by an instruction of the series of instructions. Doing so allows for the rollers of the pump to be controlled by the pump handle for a specific outcome.
Further, Fangrow teaches an air trap coupled to the fluid loop and configured to couple with the control console ([0096] the fluid transfer module 45 can include a bubble trap 15 and a destination container 44 in fluid communication with a source container 39) via an air trap holder in a first orientation during priming of the heat exchange fluid loop (Fig 7; [0106] The bubble trap 15 illustrated in FIG. 6A can have the same or nearly the same capacity, for example, when it is rotated 90 degrees along any axis or combination axes, and/or when it is rotated any number of degrees along any combination of axes (e.g., one, two, and/or three axes). And in other embodiments, the bubble trap 15 illustrated in FIG. 6A can have one or more different capacities, for example, when it is rotated 90 degrees along any axis or combination axes, and/or when it is rotated any number of degrees along any combination of axes (e.g., one, two, and/or three axes)) and couple with the control console via an air trap receptacle in a second orientation during operation of the temperature management system ([0106] Various trap capacities as a function of a bubble trap's orientation are illustrated in FIGS. 7A-7H); placement of the air trap into the air trap holder in the first orientation ([0096] the fluid transfer module 45 can include a bubble trap 15 and a destination container 44 in fluid communication with a source container 39) ([0106] , the bubble trap 15 illustrated in FIG. 6A can have one or more different capacities, for example, when it is rotated 90 degrees along any axis or combination axes, and/or when it is rotated any number of degrees along any combination of axes (e.g., one, two, and/or three axes)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include an air trap coupled to the fluid loop and configured to couple with the control console via an air trap holder in a first orientation during priming of the heat exchange fluid loop and couple with the control console via an air trap receptacle in a second orientation during operation of the temperature management system; placement of the air trap into the air trap holder in the first orientation. Doing so allows the air trap to be effective during priming and have another function during use by changing the orientation.
Further, Bonczar teaches a graphical interface comprising a series of instructions for setting up the heat exchange fluid loop wherein the series of instructions instruct the user on performing at least the following setup steps (Fig 4-7; System preparation steps); in accordance with the series of instructions (Fig 4-7; System preparation steps). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include a series of instructions for setting up the heat exchange fluid loop wherein the series of instructions instruct the user on setting up the system. It is well-known in the art to incorporate setup instructions on a graphical interface to yield the predictable result of enabling a user to setup the system for safe and effective operation of said system.
Furthermore, Aguayo teaches set up in an order by matching indicators that specify the order and are represented in each instruction of the series of instructions of setup steps with a corresponding indicator of a set of indicators located on the heat exchange fluid loop in the order, the matching indicators being at positions for guiding the setting of the heat exchange fluid loop in the control console ([6] The position indicator 102 may be any indication that informs the machine operator of the correct location of identified components. The indication may be visible, audible or detectable by any human or artificial means. In a simple configuration, the position indicator 102 may inform the machine operator of a symbol (number, letter or otherwise) that is indicative of a location. For example, FIG. 1 shows locations 107 labeled as A, B, C and D. If an identified device belongs in location D, the position indicator 102 points to letter D. A more useful configuration employs a visual indication at the site of the location. For example, if after identification the invention determines that components belong in location D, then a blinking light adjacent location D would guide the machine operator to properly place the components). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include associating the setup steps with indicators located on the heat exchange fluid loop at positions for guiding the setting of the fluid loop in the control console in accordance with the series of instructions. Doing so would make connection of the individual parts clear and ensure proper set up.
Further, Seaman teaches set up in an order by matching indicators that specify the order ([0037] the assembly manager 102 may require the human assembler 106 to complete required assembly steps 105 in the proper manner and order before proceeding to a subsequent assembly step. The assembly sequence 104, in some embodiments, may require proper orientation of a single component rather than attachment to another component to complete the assembly sequence 104). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include set up instructions in an order by matching indicators that specify the order. Doing so allows for proper connection of the components.
Regrading claim 10, Dabrowiak teaches the system of claim 1, wherein the fluid loop is coupled to a spike ([0040] Also optionally, the kit may include an air separator (not shown) to prevent air from entering the pump 110 or a dual lumen IV spike), and the series of instructions instruct the user on performing the following additional setup step: inserting the spike into a fluid bag to fluidly couple the fluid loop to the fluid bag ([0040] Also optionally, the kit may include an air separator (not shown) to prevent air from entering the pump 110 or a dual lumen IV spike). Dabrowiak fails to fully teach the series of instructions instruct the user on performing the following additional setup step.
However, Bonczar teaches the series of instructions for set up (Fig 4-7; System preparation steps). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include a series of instructions for setting up the heat exchange fluid loop wherein the series of instructions instruct the user on setting up the system. It is well-known in the art to incorporate setup instructions on a graphical interface to yield the predictable result of enabling a user to setup the system for safe and effective operation of said system.
Regarding claim 11, Dabrowiak teaches the system of claim 1, but fails to teach wherein the series of instructions instruct the user on performing the following additional setup step: placing the air trap into the air trap receptacle in the second orientation.
However, Bonczar teaches the series of instructions for set up (Fig 4-7; System preparation steps). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include a series of instructions for setting up the heat exchange fluid loop wherein the series of instructions instruct the user on setting up the system. It is well-known in the art to incorporate setup instructions on a graphical interface to yield the predictable result of enabling a user to setup the system for safe and effective operation of said system.
Further, Fangrow teaches wherein the series of instructions instruct the user on performing the following additional setup step: placing the air trap into the air trap receptacle in the second orientation (Fig 7; [0106] The bubble trap 15 illustrated in FIG. 6A can have the same or nearly the same capacity, for example, when it is rotated 90 degrees along any axis or combination axes, and/or when it is rotated any number of degrees along any combination of axes (e.g., one, two, and/or three axes). And in other embodiments, the bubble trap 15 illustrated in FIG. 6A can have one or more different capacities, for example, when it is rotated 90 degrees along any axis or combination axes, and/or when it is rotated any number of degrees along any combination of axes (e.g., one, two, and/or three axes)). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include the series of instructions instruct the user on performing the following additional setup step: placing the air trap into the air trap receptacle in the second orientation. Doing so allows the air trap to be effective during priming in the first orientation and have another function during use by changing the orientation.
Regarding claim 12, Dabrowiak teaches a first step of installing the heat exchange fluid loop (Fig 7; In the console 92 depicted in this example, the circulating heat exchange fluid is warmed or cooled by a circulation coil 98 or other heat exchanger that is submersed within a well 96 that contains warmed or cooled fluid) and closing off the heat exchange bath (Fig 7; circulation coil 98 or other heat exchanger that is submersed within a well 96) (Fig 7; heat exchange bath 96 located within console 92 which is covered as shown in Fig 1); a third step of installing the pump tube ([0049] In FIG. 8C, two tubes, tubing 78 and 79, are positioned within a single raceway); a fourth step of inserting the spike into a fluid bag to fluidly couple the fluid loop to the fluid bag ([0040] Also optionally, the kit may include an air separator (not shown) to prevent air from entering the pump 110 or a dual lumen IV spike); a fifth step of pressing and releasing a priming actuator to activate a priming sequence in response to actuation ([0046] before commencing the selected mode of heat exchange, the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system. Alternately the system may self-prime during the normal course of use), wherein the priming sequence terminates after a predetermined amount of time (the priming mode occurs during an initial set up time can is completed [0046]).
Dabrowiak fails to teach wherein the series of instructions instruct the user on performing the setup steps in the following order; a second step of placing the air trap into the air trap holder in the first orientation; a third step of installing the pump tube by operation of the pump knob; and a sixth step of placing the air trap into the air trap receptacle in the second orientation.
However, Bonczar teaches wherein the series of instructions instruct the user on performing the setup steps in the following order (Fig 4-7; System preparation steps). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include a series of instructions for setting up the heat exchange fluid loop wherein the series of instructions instruct the user on setting up the system. It is well-known in the art to incorporate setup instructions on a graphical interface to yield the predictable result of enabling a user to setup the system for safe and effective operation of said system.
Further, Fangrow teaches a second step of placing the air trap into the air trap holder in the first orientation (Fig 7; [0106] The bubble trap 15 illustrated in FIG. 6A can have the same or nearly the same capacity, for example, when it is rotated 90 degrees along any axis or combination axes, and/or when it is rotated any number of degrees along any combination of axes (e.g., one, two, and/or three axes). And in other embodiments, the bubble trap 15 illustrated in FIG. 6A can have one or more different capacities, for example, when it is rotated 90 degrees along any axis or combination axes, and/or when it is rotated any number of degrees along any combination of axes (e.g., one, two, and/or three axes)); and a sixth step of placing the air trap into the air trap receptacle in the second orientation ([0106] Various trap capacities as a function of a bubble trap's orientation are illustrated in FIGS. 7A-7H). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include a second step of placing the air trap into the air trap holder in the first orientation and a sixth step of placing the air trap into the air trap receptacle in the second orientation. Doing so allows the air trap to be effective during priming in the first orientation and have another function during use by changing the orientation.
Further, Hendricks teaches a third step of installing the pump tube by operation of the pump knob ([0030] A handle 70 is coupled at a hinge mechanism 72 to the push rod 64. The handle can be moved by hand to a substantially perpendicular orientation relative to the push rod 64 (FIGS. 6 and 9) to pull the push rod and thus to move the motor mount 56 (and hence rotor 34) toward the inner surface of the raceway 32, thereby moving the rotor 34 to the pump position). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include a third step of installing the pump tube by operation of the pump knob. Doing so connects the pump tube to operation of the knob/handle.
Regrading claim 19, Danrowiak teaches the system of claim 1, further comprising a priming actuator configured to prime the fluid loop by causing the pump to circulate fluid through the fluid loop ([0046] before commencing the selected mode of heat exchange, the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system. Once the system is primed with heat exchange fluid).
Regarding claim 33, Dabrowiak teaches the system of claim 1, but fails to teach wherein the pump knob circumference edge with multiple indentations is configured to assist a grip for torquing the pump knob.
However, Hendricks teaches wherein the pump knob circumference edge with multiple indentations is configured to assist a grip for torquing the pump knob (Fig 6; grip handle 70). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein the pump knob circumference edge with multiple indentations is configured to assist a grip for torquing the pump knob. Doing so creates a grip to effectively operate the handle.
Regarding claim 35, Dabrowiak teaches the system of claim 1, but fails to teach wherein the pump knob requires less than 2 in- lbs. of torque to rotate the knob. However, Hendricks teaches the pump knob (Fig 6; grip handle 70). It would have been an obvious matter of engineering design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the pump knob to require less than 2 in-lbs of torque to rotate , since applicant has not disclosed that less than 2 in-lbs of torque solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a minimum torque requirement being larger than 2 in-lbs. Furthermore, providing a relatively small required torque force to rotate the pump knob would be obvious to one ordinary skill in the art to yield the predictable result of enabling a user to easily rotate the knob by hand as needed.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and further in view of Aguayo (US 5283943 A) and Seaman (US 20090198365 A1), further in view of Hall (US 20120095537 A1).
Regarding claim 2, Dabrowiak and the combination teaches the system of claim 1, but fails to fully teach the control console further comprising a set of indicators each indicative of an order for interacting with the fluid loop to set up the fluid loop for operation, the set of indicators comprising: a first indicator on the bath cap; a second indicator on the air trap holder; a third indicator on a pump input; a fourth indicator on a pump output; a fifth indicator on the priming actuator; and a sixth indicator on the air trap receptacle.
However, Hall teaches the control console further comprising a set of indicators each indicative of an order for interacting with the fluid loop to set up the fluid loop for operation ([0217] The display 44 may also provide indicators when the unit components are being connected) ([0217] The display 44 may also provide indicators when the unit components are being connected. First, a picture of the system with status indicators (green solid light, red flashing light, etc) can show what components have been installed and what components are missing. Indicators can include the waste container being attached, pressure sensor connections, patient temperature connections, infusate temperature sensor connections, pump heads being closed, infusate reservoirs being attached, AC power being connected, tubing placed in pinch valves, refrigerator door closed, etc. A similar pictorial approach is used to remind the user of how to reconnect the system after a transport mode. Video tutorials can be played by the user to assist with the assembly of the LAS to the machine).
It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the display of Dabrowiak to include the control console further comprising a set of indicators each indicative of an order for interacting with the fluid loop to set up the fluid loop for operation. Doing so allows for the proper order of setting up the machine.
Further, Aguayo teaches the set of indicators on separate components comprising: a first indicator on the bath cap; a second indicator on the air trap holder; a third indicator on a pump input; a fourth indicator on a pump output; a fifth indicator on the priming actuator; and a sixth indicator on the air trap receptacle ([6] The position indicator 102 may be any indication that informs the machine operator of the correct location of identified components. The indication may be visible, audible or detectable by any human or artificial means. In a simple configuration, the position indicator 102 may inform the machine operator of a symbol (number, letter or otherwise) that is indicative of a location. For example, FIG. 1 shows locations 107 labeled as A, B, C and D. If an identified device belongs in location D, the position indicator 102 points to letter D. A more useful configuration employs a visual indication at the site of the location. For example, if after identification the invention determines that components belong in location D, then a blinking light adjacent location D would guide the machine operator to properly place the components). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include the set of indicators separate components. Doing so would make connection of the individual parts clear and ensure proper set up.
Regarding claim 3, the combination fails to fully teach wherein each indicator of the set of indicators corresponds to the series of instructions including depictions of each of the indicators.
However, Aguayo teaches wherein each indicator of the set of indicators corresponds to the series of instructions including depictions of each of the indicators ([6] The position indicator 102 may be any indication that informs the machine operator of the correct location of identified components. The indication may be visible, audible or detectable by any human or artificial means. In a simple configuration, the position indicator 102 may inform the machine operator of a symbol (number, letter or otherwise) that is indicative of a location. For example, FIG. 1 shows locations 107 labeled as A, B, C and D. If an identified device belongs in location D, the position indicator 102 points to letter D. A more useful configuration employs a visual indication at the site of the location. For example, if after identification the invention determines that components belong in location D, then a blinking light adjacent location D would guide the machine operator to properly place the components). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein each indicator of the set of indicators corresponds to the series of instructions including depictions of each of the indicators. Doing so would make connection of the individual parts clear and ensure proper set up.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and in view of Aguayo (US 5283943 A) and Seaman (US 20090198365 A1), further in view of Machold (US 8246669 B2).
Regarding claim 13, the combination teaches the system of claim 1, but fails to fully wherein the air trap holder is keyed to orient the air trap in the first orientation. However, Machold teaches wherein the air trap holder is keyed to orient the air trap in the first orientation ([93] The valve is biased into the up position, that is the position that seals the filling channel 88, and opens the inflow channel 86. In a preferred embodiment the pump would continue to run for a period of time after the level sensor indicated that the system was full to ensure that any air bubbles in the catheter or the external heat exchanger or the bulkhead would be expelled into the reservoir 58 where they could vent to the atmosphere). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein the air trap holder is keyed to orient the air trap in the first orientation. Doing so uses the valve of Machold which could be used as an air trap to be biased in a position for the release of air bubbles.
Claim(s) 14-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and Aguayo (US 5283943 A) further in view of Dabrowiak (2) (US 20180325725 A1).
Regarding claim 14, the combination teaches the system of claim 1, but fails to fully teach further comprising a pump lid, the pump lid configured to prevent manipulation of the pump rotor during operation of the pump, the pump lid comprising a marking indicating a handle to open the pump lid from the pump.
However, Dabrowiak (2) teaches further comprising a pump lid (Fig 1; openable/closable access cover 42), the pump lid configured to prevent manipulation of the pump rotor during operation of the pump ([0055] FIGS. 3 and 4, the cassette 64 of the tubing/cassette/sensor module assembly 60 is inserted through an openable/closable access cover 42 of the control console 14 and into a cassette receiving space 66 positioned between thermal exchange plates 80 and the pump tubing 65 is insertable into a tubing raceway 72 of pump 70), the pump lid comprising a marking indicating a handle to open the pump lid from the pump. It would have been an obvious matter of design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to include the pump lid comprising a marking indicating a handle to open the pump lid from the pump, since applicant has not disclosed that a marking indicating a handle to open the pump lid from the pump solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with an openable/closeable access cover.
Regarding claim 15, the combination teaches the system of claim 1, but fails to fully teach the pump further comprising a pump latch, wherein a first portion of the latch is coupled to a pump body and a corresponding second portion of the latch is coupled to the pump lid, wherein the first portion and the second portion connect to hold the lid closed, and wherein less than 5 lbs of force is required to separate the first portion from the second portion to open the lid.
However, Dabrowiak teaches the pump further comprising a pump latch, wherein a first portion of the latch is coupled to a pump body and a corresponding second portion of the latch is coupled to the pump lid (Fig 1), wherein the first portion and the second portion connect to hold the lid closed ([0055] inserted through an openable/closable access cover 42), and wherein less than 5 lbs of force is required to separate the first portion from the second portion to open the lid. It would have been an obvious matter of engineering design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified wherein less than 5 lbs of force is required to separate the first portion from the second portion to open the lid, since applicant has not disclosed that less than 5 lbs of force solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with a minimum force requirement being larger than 5 lbs Furthermore, providing a relatively small required force to open the lid would be obvious to one ordinary skill in the art to yield the predictable result of enabling a user to easily open the lid as needed.
Regarding claim 16, the combination teaches the system of claim 1, but fails to fully teach wherein the bath cap is coupled to the heat exchange bath by a retaining device.
However, Dabrowiak teaches wherein the bath cap is coupled to the heat exchange bath by a retaining device ([0055] inserted through an openable/closable access cover 42). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein the bath cap is coupled to the heat exchange bath by a retaining device. Doing so creates a place for the exchange bath to be held in the main console with a cover.
Regarding claim 17, the combination teaches the system of claim 14, but fails to fully teach wherein the retaining device is a strap that prevents the bath cap from being separated from the heat exchange bath.
However, Dabrowiak teaches wherein the retaining device is a cover that prevents the bath cap from being separated from the heat exchange bath ([0055] inserted through an openable/closable access cover 42). It would have been an obvious matter of engineering design choice to one having ordinary skill in the art at before the effective filing date of the claimed invention to have modified the retaining device to include a strap, since applicant has not disclosed that a strap solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with an openable/closable access cover. Furthermore, providing a cover that prevents the bath cap from being separated from the heat exchange bath would be obvious to one ordinary skill in the art to yield the predictable result of enabling a user to easily open and close the bath as needed.
Regarding claim 18, the combination teaches the system of claim 1, but fails to fully teach wherein the bath cap is physically coupled to the control console when the bath cap is not closing off the heat exchange cavity.
However, Dabrowiak teaches wherein the bath cap is physically coupled to the control console when the bath cap is not closing off the heat exchange cavity ([0055] FIGS. 3 and 4, the cassette 64 of the tubing/cassette/sensor module assembly 60 is inserted through an openable/closable access cover 42 of the control console 14). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein the bath cap is physically coupled to the control console when the bath cap is not closing off the heat exchange cavity. Doing so allows for the cap to be attached to the console so that it is not misplaced when taken off.
Claim(s) 9, 21, 22, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and Aguayo (US 5283943 A) and Seaman (US 20090198365 A1), further in view of Machold (US 6695874 B2).
Regarding claim 9, Dabrowiak teaches the system of claim 1, wherein the control console further comprises a priming actuator and the series of instructions instruct the user on performing the following additional setup step ([0046] before commencing the selected mode of heat exchange, the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system. Alternately the system may self-prime during the normal course of use). Dabrowiak fails to fully teach pressing and releasing a priming actuator to activate a priming sequence in response to actuation, wherein the priming sequence terminates after a predetermined amount of time.
However, Machold teaches pressing and releasing a priming actuator to activate a priming sequence in response to actuation ([131] When the disposable heat exchange cassette 400b of the invention is first put into operation, the unit is initially filled with heat exchange fluid from an external fluid source such as an IV bag of saline attached to the fill port 632 leading to the fill channel 634. In addition, the linear actuator 418 of the valve actuation system 416 is activated, to place the priming valve 670 in its first position (FIG. 14E) with the valve member 676 depressed sufficiently to allow fluid to flow from the IV bag into the valve chamber 636), wherein the priming sequence terminates after a predetermined amount of time ([132] when the fluid level in the reservoir section 550 rises to a sufficient level, a signal is sent to the reusable master control unit to deactivate the linear actuator 416 so that it moves to a released position, thus withdrawing the push rod 420, resulting in the valve member 676 being biased back to its second position (FIG. 14D)) ([133] In a preferred embodiment the pump would continue to run for a period of time after the level sensor indicated that the system was full to ensure that any air bubbles in the catheter or the external heat exchanger or the bulkhead would be expelled into the reservoir section 550 where they could vent to the atmosphere). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include pressing and releasing a priming actuator to activate a priming sequence in response to actuation, wherein the priming sequence terminates after a predetermined amount of time. Doing so initiates a priming sequence by pressing a button and having it run for a determined time as it primes the system.
Regarding claim 21, Dabrowiak teaches the system of claim 19, wherein the priming actuator is configured to activate a priming sequence in response to actuation ([0046] before commencing the selected mode of heat exchange, the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system), but fails to teach and wherein the priming sequence terminates after a predetermined amount of time.
However, Machold teaches and wherein the priming sequence terminates after a predetermined amount of time ([132] when the fluid level in the reservoir section 550 rises to a sufficient level, a signal is sent to the reusable master control unit to deactivate the linear actuator 416 so that it moves to a released position, thus withdrawing the push rod 420, resulting in the valve member 676 being biased back to its second position (FIG. 14D)) ([133] In a preferred embodiment the pump would continue to run for a period of time after the level sensor indicated that the system was full to ensure that any air bubbles in the catheter or the external heat exchanger or the bulkhead would be expelled into the reservoir section 550 where they could vent to the atmosphere). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein the priming sequence terminates after a predetermined amount of time. Doing so has it run for a determined time as it primes the system.
Regarding claim 22, Dabrowiak teaches the system of claim 21, wherein the priming actuator is configured to activate the priming sequence ([0046] before commencing the selected mode of heat exchange, the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system), but fails to fully teach in response to a single press and release of the priming actuator. However, Machold teaches wherein the priming actuator is configured to activate the priming sequence in response to a single press and release of the priming actuator ([131] he linear actuator 418 of the valve actuation system 416 is activated, to place the priming valve 670 in its first position (FIG. 14E)).
Regarding claim 32, the Dabrowiak teaches the system of claim 1, but fails to fully teach wherein the pump knob extends from an axis of the rotor and rotates around the axis of the rotor, the axis of the rotor being normal to the flat surface, and wherein the flat surface extends over at least one roller of the set of rollers.
However, Hendricks teaches wherein the pump knob extends from an axis of the rotor ([0030] A handle 70 is coupled at a hinge mechanism 72 to the push rod 64. The handle can be moved by hand to a substantially perpendicular orientation relative to the push rod 64 (FIGS. 6 and 9) to pull the push rod and thus to move the motor mount 56 (and hence rotor 34) toward the inner surface of the raceway 32, thereby moving the rotor 34 to the pump position. The handle can also be moved by hand down from the perpendicular orientation to the non-perpendicular orientation shown in FIGS. 7 and 8. This pushes the push rod 64 and thus moves the motor mount 56/rotor 34 away from the pump position to the tube load position), the axis of the rotor being normal to the flat surface, and wherein the flat surface extends over at least one roller of the set of rollers (Fig 6; rollers 48 and 46).
Further, Machold teaches and rotates around the axis of the rotor (Fig 6; The pump section 100 has a quasi-cardioid shaped cavity 104, into which is positioned a pump head 140 that comprises a rotor 106). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein the pump knob extends from an axis of the rotor, the axis of the rotor being normal to the flat surface, and wherein the flat surface extends over at least one roller of the set of rollers, and rotates around the axis of the rotor. Doing so allows for control of the rotor and rollers by the pump knob/handle and is set in relation to the axis of the rollers.
Claim(s) 70 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dabrowiak (US 20180207024 A1) in view of Hendricks (US 20160131127 A1), Fangrow (US 20190151569 A1), and Bonczar (US 20190365979 A1), and Aguayo (US 5283943 A) and Seaman (US 20090198365 A1), further in view of Norris (US 20160101278 A1).
Regarding claim 70, Dabrowiak teaches the system of claim 1, wherein the series of instructions includes one or more instructions for priming the heat exchange fluid loop ([0046] the controller 36 may prompt a user to initialize a primary or initial set up mode for priming and removal of air from the system. Alternately the system may self-prime during the normal course of use. If the optional air-trap 108 is used), but fails to teach wherein the set of indicators located on the heat exchange fluid loop comprise at least one indicator for reconfiguring a portion of the heat exchange fluid loop after priming is initiated.
However, Aguayo teaches the set of indicators located on the heat exchange fluid loop ([6] The position indicator 102 may be any indication that informs the machine operator of the correct location of identified components. The indication may be visible, audible or detectable by any human or artificial means. In a simple configuration, the position indicator 102 may inform the machine operator of a symbol (number, letter or otherwise) that is indicative of a location. For example, FIG. 1 shows locations 107 labeled as A, B, C and D. If an identified device belongs in location D, the position indicator 102 points to letter D. A more useful configuration employs a visual indication at the site of the location. For example, if after identification the invention determines that components belong in location D, then a blinking light adjacent location D would guide the machine operator to properly place the components). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include the set of indicators located on the heat exchange fluid loop. Doing so would make connection of the individual parts clear and ensure proper set up.
Further, Norris teaches wherein the set of indicators comprise at least one indicator for reconfiguring a portion of the heat exchange fluid loop after priming is initiated ([0337]) The controller may then proceed to direct the priming of line 34, to direct termination of priming once line 34 is primed, and then to instruct the user to disengage the distal end of line 34 from the patient line state detector 1000 and connect it to the user's peritoneal dialysis catheter). It would have been obvious to one of ordinary skill in the art before the effective filling date to have modified the invention of Dabrowiak to include wherein the set of indicators comprise at least one indicator for reconfiguring a portion of the heat exchange fluid loop after priming is initiated. Doing so allows for instructions to connect the fluid lines before and after priming.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEIGH LAUREN KERN whose telephone number is (703)756-4577. The examiner can normally be reached 7:30 am - 4:30 pm.
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/ASHLEIGH LAUREN KERN/Examiner, Art Unit 3794
/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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