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 amendment filed 05/26/2026 has been entered. Claims 1-25 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed 02/24/2026.
Response to Arguments
Applicant's arguments with respect to claims 1-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Rejections - 35 USC § 103
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 1-2, 4-6, 9, 14-15 & 18-21 are rejected under 35 U.S.C 103 as being unpatentable over LIANG et al. (US 20200246180) herein referred to as LIANG in view of Collins et al. (US 11547601) herein referred to as Collins.
Regarding Claim 1, LIANG discloses A targeted temperature management (TTM) system (Figure 21B), comprising: a TTM module configured to provide a TTM fluid (Figure 21B, 2150); a thermal pad configured to receive the TTM fluid from the TTM module to facilitate thermal energy transfer between the TTM fluid and a patient (Figure 14); a multi-conduit fluid delivery line extending between the TTM module and the thermal pad (Figure 21B, 2140 & Fig 22), the fluid delivery line configured to provide TTM fluid flow from the TTM module to the thermal pad (Paragraph [0134]; wherein the delivery line is configured to deliver fluid delivery to the pad); and a connection system configured to provide a connectivity indication to a user (Paragraph [0097]; wherein the connection system provides electrical connectivity to a device controller through sensor feedback indicating connectivity to a user), the connection system comprising: a first connector attached to the fluid delivery line (Figure 14, 1414), a corresponding second connector attached to the thermal pad (Paragraph [0097]; wherein the connector can be connected to the thermal pad), and a connectivity sensor configured to determine if the first connector is connected to the second connector (Paragraph [0097]; wherein the connection system uses a sensor feedback for connectivity therefore contains a sensor).. However, Liang does not explicitly disclose a first connectivity sensor attached to the first connector, and a second connectivity sensor attached to the second connector, wherein: the first connectivity sensor and the second connectivity sensor are configured to determine if the first connector is connected to the second connector, and the connectivity indication is only provided when the first connectivity sensor and the second connectivity sensor are interactively coupled.
Collins discloses a targeted temperature management system (Figure 1) comprising a First connectivity sensor attached to a first connector (Figure 5, 228; Claim 10; wherein a contact sensor in a fitting of the connector) and a second connectivity sensor attached to the second connector (Figure 5, 226; Claim 10; wherein a contact sensor in a fitting of the connector), wherein: the connectivity sensor is configured to determine if the first connector is connected to the second connector (Claim 10; wherein the connectivity sensor is configured to generate a signal indicating that the connector is connecting the at least one catheter connector to the first working fluid loop) and the connectivity indication is only provided when the first connectivity sensor and the second connectivity sensor are interactively coupled (Claim 10; wherein the connectivity sensor is configured to generate a signal indicating that the connector is connecting the connector to the first working fluid loop and second working fluid loop). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified connection system taught by LIANG to include the connectivity sensors as taught by Collins The motivation being based on the sensor feedback to change one or more control parameters for controlling a pump or a valve for changing fluid flow (Collins, Claim 10).
Regarding claim 2, LIANG in view of Collins discloses the system of claim 1. Liang also discloses wherein the connectivity indication is a confirming indication that the first connector is completely connected to the second connector (Paragraph [0097]; wherein the connection is based on electrical connectivity therefore if there is no electrical power being transferred it would confirm the first and second connectors are not connected).
Regarding claim 4, LIANG in view of Collins discloses the system of claim 1. LIANG also discloses wherein the connectivity system comprises one or more indicia indicating proper orientation of the first connector with respect to the second connector (Paragraph [0141]; wherein a connector may comprise physical latching features to allow the connector and parts to be connected or disconnected. In some embodiments, the connector may comprise visual locating features to assist in orientation and/or implementation/removal of the air-tight/water-tight connection between controller, cable, and/or sleeve)
Regarding claim 5, LIANG in view of Collins discloses the system of claim 1. LIANG also discloses wherein the connection system further comprises a connection controller coupled to the connectivity sensor, the connection controller including controller logic (Paragraph [0097]; wherein the connection system provides electrical connectivity to a device controller through sensor feedback indicating connectivity to a user)
Regarding claim 6, LIANG in view of Collins discloses the system of claim 5. LIANG also discloses wherein the first connector comprises the connection controller (Paragraph [0097]; wherein either connector end can comprise the controller)
Regarding claim 9, LIANG in view of Collins discloses the system of claim 5. LIANG also discloses wherein the connection system further comprises a connector lock configured to selectively allow and prevent separation of the first connector from the second connector (Paragraph [0095]; wherein electrical connector may be further configured to maintain a hermetic seal, which may be achieved through mechanical interference, one or more O-rings, gaskets, adhesives, sealants, grease, and plugs, or the like)
Regarding claim 14, LIANG in view of Collins discloses the system of claim 5. LIANG also discloses wherein: the connection controller is coupled to the TTM module (Paragraph [0131]; wherein the TTM module is apart of the controller therefore are coupled); the controller logic provides the connectivity indication to the TTM module (Paragraph [0097]; wherein the connection system provides electrical connectivity to a device controller through sensor feedback indicating connectivity); the TTM module comprises a TTM module console including TTM Module logic (Paragraph [0131]; wherein temperature control of the warming therapy may be open-loop or closed-loop (e.g., automatically controlled to maintain the desired temperature profile, such as in response to a sensor feedback); and wherein TTM module logic is configured to selectively allow and prevent TTM fluid flow to the pad in accordance with the connectivity indication (Paragraph [0131]; wherein fluid can delivered based on sensor feedback such as the connectivity feedback taught in Paragraph [0097]).
Regarding claim 15, LIANG in view of Collins discloses the system of claim 14. LIANG also discloses wherein the controller logic is configured to provide one or more signals to the TTM module in accordance with signals received from the connection system, temperature sensor, and/or the flow sensor (Paragraph [0087]; wherein temperature sensors may be utilized to help regulate the temperature of the pad below a maximum temperature and/or above a minimum temperature such that it may be maintained such that the temperature remains within a temperature range and/or oscillates between a maximum and minimum temperature at a predetermined period or frequency)
Regarding claim 18, LIANG in view of Collins discloses the system of claim 1. LIANG also discloses wherein the fluid delivery line comprises a first conduit and a second conduit (Figure 22, 2202 & 2204), and wherein the first conduit is disposed within second conduit along a length of the fluid delivery line (Figure 22, 2202 & 2204)
Regarding claim 19, LIANG in view of Collins discloses the system of claim 18. LIANG also discloses wherein, in use, a direction fluid flow through the first conduit is from the TTM module toward the thermal pad (Paragraph [0134]).
Regarding claim 20, LIANG in view of Collins discloses the system of claim 18. LIANG also discloses wherein the first conduit is concentrically positioned within the second conduit (Figure 22, 2202 & 2204).
Regarding claim 21, LIANG in view of Collins discloses the system of claim 20. LIANG also discloses wherein, the first conduit is attached to the second conduit along the length of the fluid delivery line (Figure 22, 2202 & 2204; wherein the first conduit is attached to the second conduit at the connector end).
Claims 3, 7-8, 13 & 16 is rejected under 35 U.S.C 103 as being unpatentable over LIANG and Collins in further view of Badawi et al. (US 20210022914) herein referred to as Badawi.
Regarding Claim 3, LIANG in view of Collins discloses the system of claim 1. However, LIANG in view of Collins does not explicitly disclose wherein the connectivity indication comprises an illuminating indicium.
Badawi discloses a TTM system (Figure 3) wherein the connectivity indication comprises an illuminating indicium (Figure 5A & 5B, 58). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the indication taught by LIANG in view of Collins to be an illuminating indicium. The motivation being to provide a visual indication to a user when connected to another source (Badawi, Paragraph [0081]).
Regarding Claim 7, LIANG in view of Collins discloses the system of claim 5. However, LIANG in view of Collins does not explicitly disclose wherein the connection system comprises a display coupled to the connection controller, and wherein the controller logic is configured to render the connectivity indication on the display.
Badawi discloses a TTM system (Figure 3) wherein the connection system comprises a display coupled to the connection controller (Figure 4, 58, 62, 64, 66), and wherein the controller logic is configured to render the connectivity indication on the display (Paragraph [0083]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection system taught by LIANG in view of Collins to include a display as taught by Badawi. The motivation being to provide a visual indication to a user when connected to another source (Badawi, Paragraph [0081]).
Regarding Claim 8, LIANG and Collins in view of Badawi discloses the system of claim 7. Badawi also discloses wherein the connection controller and the display are disposed within a controller housing (Figure 4, 52) Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG in view of Collins to include the controller structure as taught by Badawi. The motivation being the controller housing allows for the other elements to be incorporated into the design such as visual indication, connection elements and charging elements (Badawi, Paragraph [0081]).
Regarding Claim 13, LIANG and Collins in view of Badawi discloses the system of claim 7. LIANG also discloses wherein: the connection system further comprises a temperature sensor configured to measure a TTM fluid temperature (Paragraph [0097]; wherein the connector can comprise a temperature sensor); the temperature sensor is coupled to the connection controller (Paragraph [0126]; wherein fluid temperature may be monitored and/or controlled using a temperature residing in the controller and/or the sleeve, temperature regulation may be manually controlled by a user and/or automatically via an external temperature input); Badawi also discloses wherein the controller logic is configured render a TTM fluid temperature indication on the display (Figure 4, 64). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the connection system as taught by LIANG in view of Badawi to allow for the temperature indication to be displayed on the display. The motivation being to provide a visual indication to a user (Badawi, Paragraph [0081]).
Regarding Claim 16, LIANG in view of Collins discloses the system of claim 14. However, LIANG in view of Collins does not explicitly disclose wherein controller logic is configured to render a visualization on the display indicating that separation of the first connector from the second connector is allowed in accordance with a signal received from the TTM module controller.
Badawi discloses a TTM system (Figure 3) wherein controller logic is configured to render a visualization on the display indicating that separation of the first connector from the second connector is allowed in accordance with a signal received from the TTM module controller (Figure 5A &5B; wherein the indicators in 5A & 5B, illuminate only when there is a connector plugged in and when connectors are disconnected and separated no longer illuminate therefore render a visualization on the display). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG to include a visual representation of connection and disconnection taught by Badawi. The motivation being to provide a visual indication to a user when connected to another source (Badawi, Paragraph [0081]).
Claim 10 & 17 are rejected under 35 U.S.C 103 as being unpatentable over LIANG and Collins in further view of Hopper et al. (US 20210060230) herein referred to as Hopper.
Regarding Claim 10, LIANG discloses the system of claim 9. However, LIANG in view of Collins does not explicitly disclose wherein the connection system further comprises an actuator coupled to the connection controller and the connector lock, and wherein the controller logic is configured to selectively 1) activate the connector lock preventing separation of the first connector from the second connector, and 2) deactivate the connector lock allowing separation of the first connector from the second connector.
Hopper discloses a TTM system (Figure 5) wherein the connection system further comprises an actuator coupled to the connection controller and the connector lock (Figure 5, 136), and wherein the controller logic is configured to selectively 1) activate the connector lock preventing separation of the first connector from the second connector (Paragraph [0093]; wherein valves or restrictors control the amount of fluid that is output such that when the valve/restrictors are opened, the first connector and second connector should not disconnect), and 2) deactivate the connector lock allowing separation of the first connector from the second connector (Paragraph [0093]; wherein valves or restrictors control the amount of fluid that is output such that when the valve/restrictors are closed, the first connector and second connector can disconnect). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG in view of Collins to include an actuator as taught by Hopper. The motivation being to control the fluid being output (Hopper, Paragraph [0093]).
Regarding Claim 17, LIANG in view of Collins discloses the system of claim 14. However, LIANG in view of Collins does not explicitly disclose wherein the controller logic is configured to activate and/or deactivate the lock in accordance with a signal from the TTM module.
Hopper discloses a TTM system (Figure 5) wherein the controller logic is configured to activate and/or deactivate the lock in accordance with a signal from the TTM module (Paragraph [0093]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG to include the controller logic taught by Hopper. The motivation being to control the fluid being output (Hopper, Paragraph [0093]).
Claim 11 & 12 are rejected under 35 U.S.C 103 as being unpatentable over LIANG, Collins and Badawi in further view of Hopper.
Regarding Claim 11, LIANG and Collins in view of Badawi disclose the system according to claim 7. However, LIANG and Collins in view of Badawi does not explicitly disclose wherein: the connection system further comprises a flow sensor configured to measure a TTM fluid flow rate; the flow sensor is coupled to the connection controller; and the controller logic is configured to render a TTM fluid flow rate indication on the display.
Hopper discloses a TTM system (Figure 5 wherein: the connection system further comprises a flow sensor configured to measure a TTM fluid flow rate (Figure 5, 142); the flow sensor is coupled to the connection controller (Paragraph [0095]; wherein the flow meter measures the flow rate of the fluid returning from a corresponding thermal pad and reports to the measured flow rate to controller); and the controller logic is configured to render a TTM fluid flow rate indication on the display (Paragraph [0071]). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG and Collins in view of Badawi to include a flow sensor as taught by Hopper. The motivation being to be able to adjust flow rates or use them to calculate other values (Hopper, Paragraph [0095]).
Regarding claim 12, LIANG, Collins and Badawi in further view of Hopper disclose the system of claim 11. Hopper also discloses wherein the controller logic is configured to activate and/or deactivate the lock in accordance with a signal from the flow sensor (Paragraph [0095]; wherein for feedback purposes e.g. flow meters may be used as closed loop feedback for controlling restrictors). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG in view of Badawi to include a flow sensor as taught by Hopper. The motivation being to be able to adjust flow rates or use them to calculate other values (Hopper, Paragraph [0095]).
Claims 22-25 are rejected under 35 U.S.C 103 as being unpatentable over LIANG and Collins in view of Steele et al. (US 11285039) herein referred to as Steele.
Regarding Claim 22, LIANG discloses the system according to claim 1. However, LIANG in view of Collins does not explicitly disclose further comprising a filter disposed in line with a TTM fluid flow path.
Steele discloses TTM system (Figure 1) comprising a filter disposed in line with a TTM fluid flow path (Figure 1, 30). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG in view of Collins to include a filter as taught by Steele. The motivation being to remove organic compounds from the feed water that are capable of forming an adherent layer on the porous surface (Steele, Column 1 lines 66-67 & Column 2 lines 1-2)
Regarding Claim 23, LIANG and Collins in view of Steele disclose the system according to claim 22. Steele also discloses wherein the filter comprises a porous wall disposed parallel to a flow direction of TTM fluid along the TTM fluid flow path (Figure 3, 44; wherein Figure 3 is the porous wall of the filter). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system taught by LIANG in view of Collins to include a filter as taught by Steele. The motivation being to remove organic compounds from the feed water that are capable of forming an adherent layer on the porous surface (Steele, Column 1 lines 66-67 & Column 2 lines 1-2)
Claims 24-25 are rejected under 35 U.S.C 103 as being unpatentable over LIANG and Collins and Steele in further view of Sinha et al. (US 20200129325) herein referred to as Sinha.
Regarding Claim 24, LIANG and Collins in view of Steele disclose the system according to claim 22. However, LIANG and Collins in view of Steele does not explicitly disclose wherein the filter is attached to the thermal pad.
Sinha discloses a TTM system (Figure 1) wherein the filter is attached to the thermal pad (Figure 3, 64; Figure 1; wherein filter is not labeled in Figure 1 but it is connected to the thermal pad 32). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as taught by LIANG and Collins in view of Steele to allow for the filter to be connected to the thermal. The motivation being to filter out the fluid as entering the pad (Sinha, Paragraph [0039]).
Regarding Claim 25, LIANG and Collins in view of Steele disclose the system according to claim 22. However, LIANG and Collins in view of Steele does not explicitly disclose wherein the filter is disposed within a fluid containing layer of the thermal pad.
Sinha discloses a TTM system (Figure 1) wherein the filter is disposed within a fluid containing layer of the thermal pad (Figure 3, 64; Figure 1; wherein filter is not labeled in Figure 1 but it is inside of the thermal pad 32). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the system as taught by LIANG and Collins in view of Steele to allow for the filter to be connected to the thermal. The motivation being to filter out the fluid as entering the pad (Sinha, Paragraph [0039]).
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 ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights