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 .
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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 March 2026 has been entered.
Response to Arguments
Applicant's arguments filed 05 February 2026 have been fully considered but they are not persuasive.
Applicant argues that Richardson cannot read on claims 1 and 16 as the claimed distal manifold hub cannot read on Richardson’s flow divider 143 in one instance, and in the next instance, its proximal and distal FDL hub connectors on ends of the flow divider 143 and the primary fluid line 110 or the primary return line 112. However, this is not found to be persuasive. As stated in the rejection of claim 21 in the Office Action dated 05 December 2025, it is an end of 143 that connects to 112 or 110 as in Fig. 6 that reads on a proximal hub connector and an end of 112 or 110 that connects to 143 in Fig. 6 that reads on a distal FDL connector. Stated another way, it is the points/location of the connections themselves (and not the entire hub or FDL) that read on the connectors of claim 21 (which has been incorporated into claims 1 and 16). Applicant has not claimed that these connections be connectable and disconnectable from each other only that they are configured to connect which Richardson shows in Fig. 6.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1 and 6-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2011/0152982 A1 to Richardson (Richardson) in view of US 5,494,074 to Ramacier, Jr. et al. (Ramacier) and US 2014/0094881 A1 to Dabrowiak et al. (Dabrowiak).
Regarding claim 1, Richardson teaches a fluid delivery line (FDL) for use in transporting a targeted temperature management (TTM) fluid between a TTM module and a plurality of thermal-contact pads applied to a patient (Fig. 6), the FDL comprising a proximal FDL connector (Fig. 6 where 110 and 112 of 108 are connected to 104a) at a proximal point of the FDL configured to connect with the TTM module (Fig. 6), an FDL conduit (108) including a fluid delivery lumen (110), a fluid return lumen (112) in a side- by-side arrangement with the fluid delivery lumen (Fig. 4/Fig. 6) and a bifurcation in the FDL defining a pair of FDL conduit legs (Fig. 6) and a pair of distal manifold hubs (143) respectively coupled to the pair of FDL legs at a distal end of the FDL (Fig. 6), each distal manifold hub of the pair of distal manifold hubs includes a proximal hub connector (end of 143 that connects to 112 or 110 as in Fig. 6) configured to connect to a distal FDL connector (end of 112 or 110 that connects to 143 as in Fig. 6) at the distal end of the FDL (Fig. 6), each distal manifold hub configured for respectively connecting to a plurality of pad connectors of the a plurality of thermal contact pads (Fig. 6).
However, Richardson in Fig.6 is silent with respect to each of the distal hub connectors of the plurality of distal hub connectors including a displaceable member configured to engage or disengage a pad to hub latching mechanism to respectively secure or release a corresponding pad connector of the plurality of pad connectors from the distal hub connector.
Richardson in Fig. 3 teaches a manifold hub (114) that includes quick connect couplings (144) that include an internal lock, that when the quick connect couplings are properly situated over and pressed down on the complimentary ports, the couplings are locked into fluid communication with the fluid supply/return. The quick connect couplings are removed by actuating a release (146) and when removed from a complementary port, a check valve in the quick connect coupling is closed to prevent fluid from leaking, and that although the invention is described using the particular quick connect coupling described, those of ordinary skill in the art will recognize that other quick connect couplings, which produce the same or similar results, may be used in additional embodiments ([0037]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the quick connect couplings in Fig. 3 of Richardson so as to allow for connection to the manifold and leak free disconnection as taught by Richardson ([0037)).
However, Richardson is silent with respect to the displaceable member being a button.
Ramacier teaches an analogous quick connect coupling valve assembly (title) to that of Richardson including wherein the displacement member is a button (81). It would have been obvious to one having ordinary skill in the art to have selected a button as taught by Ramacier as an obvious selection of one known actuating mechanism as an obvious matter of engineering design choice. This is especially true as Richardson teaches although the invention is described using the particular quick connect coupling described, those of ordinary skill in the art will recognize that other quick connect couplings, which produce the same or similar results, may be used in additional embodiments ([0037)).
However, Richardson is silent with respect to an authentication tag incorporated into the FDL.
Dabrowiak teaches an analogous device (Fig. 1) to that of Richardson including a fluid delivery line (supply and return lines 16, 18) for transporting a targeted temperature management (TTM) fluid between a TTM module (system 12) and a treatment device (catheter 10). The device of Dabrowiak includes a near field communication (NFC) member associated with the heat exchange system and an NFC element associated with the heat exchange catheter line assembly to provide the processor with a signal representative of whether the NFC member detects the NFC element (abstract). The NFC member is configured to cause the NFC reader to determine that the line assembly is an assembly approved for use with the heat exchange system ([0008]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Richardson to include the NFC of Dabrowiak in order to allow for the communication of relevant use information at the time of connection as taught by Dabrowiak ([abstract and [0008, 0019-0021]).
Regarding claim 6, the combination teaches the FDL of claim 1, as well as Ramacier teaching wherein the button is configured to disengage the latching mechanism when pressed, thereby allowing the corresponding connector to be released from a corresponding connector (Col. 6, lines 3-5 which states “To release the female and male coupling members 42, 44, the tab portion 81...is simply depressed.”). It would have been obvious to one having ordinary skill in the art to have selected a button as taught by Ramacier as an obvious selection of one known actuating mechanism as an obvious matter of engineering design choice. This is especially true as Richardson teaches although the invention is described using the particular quick connect coupling described, those of ordinary skill in the art will recognize that other quick connect couplings, which produce the same or similar results, may be used in additional embodiments ([0037]).
Regarding claim 7, the combination teaches the FDL of claim 1, as well as Ramacier teaching wherein the button is configured to disengaged the latching mechanism when pressed, thereby allowing the corresponding connector to be secured to a corresponding connector(Col. 6, lines 3-5 which states “To release the female and male coupling members 42, 44, the tab portion 81...is simply depressed.” Therefore, when the tab is depressed it allows the connector to slide on and off of the corresponding connector.). It would have been obvious to one having ordinary skill in the art to have selected a button as taught by Ramacier as an obvious selection of one known actuating mechanism as an obvious matter of engineering design choice. This is especially true as Richardson teaches although the invention is described using the particular quick connect coupling described, those of ordinary skill in the art will recognize that other quick connect couplings, which produce the same or similar results, may be used in additional embodiments ([0037]).
Regarding claim 8, the combination teaches the FDL of claim 1 as well as Ramacier teaching wherein each connector including a sealing member configured to define a seal with a valve of the corresponding connector when secured together (abstract which states in part “A quick connection coupling valve assembly having a poppet member in both a male coupling member and a female coupling member, a fluid passageway defined therethrough is opened by engaging the poppet members of the male and female coupling members with each other, the fluid passageway is closed by releasing a spring member to disengage the poppet members from each other.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the sealing member of Ramacier so as to quickly lock and release the connection coupling valve without any fluid leakage which is a stated goal of Ramacier (Col. 1, lines 22-25).
Regarding claim 9, the combination teaches the FDL of claim 8 as well as Ramacier teaching wherein the valve is biased toward a closed state such that the valve of the corresponding connector automatically closes when the corresponding connector is disconnected (Col. 5, lines 22-42 which states in part “Therefore, the spring members 72,74 will bias the poppet members 62,64 forward when the tip ends 68,70 are disengaged from each other as is the case when the male coupling member 44 is disconnected from the female coupling member 46. Upon being biased forward, the poppet members 62,64 will close and seal the fluid passageways through the female and male coupling members 42,44, respectively.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have biased the valve to be closed so as to seal the fluid passageways once disengaged and prevent leakage of fluid which is a stated goal of Ramacier (Col. 1, lines 22-25).
Regarding claims 10-12, the combination teaches the FDL of claim 1, but not specifically wherein the authentication tag is incorporated into the proximal FDL connector, the FDL conduit, a distal manifold hub of the pair of distal manifold hubs or a distal hub connector of the one-or-more distal hub connectors. However, given the teaching of Dabrowiak that it is advantageous to include an NFC member on the fluid delivery parts being connected to the heat exchange system to allow for the communication of relevant use information at the time of connection as taught by Dabrowiak ([abstract and [0008, 0019-0021]), it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have located the NFC as claimed to provide the relevant use information at the time of connection as an obvious matter of engineering design choice due to a lack of disclosed criticality or unexpected results. The motivation to do so can be found in Dabrowiak which discusses how the identification of connected parts benefits the use of the system ([abstract and [0008, 0019-0021]).
Regarding claim 13, the combination teaches the FDL of claim 1 as well as Dabrowiak teaching wherein the authentication tag stores information in memory thereof, the identification information selected from a manufacturer’s identification ([0031, 0040]); product specific information including FDL model indication, an FDL part number, or a combination thereof; and manufacturing information including manufacturing date, lot number, or a combination thereof. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the identification information as taught by Dabrowiak so as to allow for the proper functioning of the device as taught by Dabrowiak such as preventing abnormal, unauthorized or unapproved connection to the system ([0027]).
Claim(s) 2-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richardson, Ramacier and Dabrowiak as applied to claim 1 above, and further in view of US 2016/0022477 A1 to Schaefer et al. (Schaefer).
Regarding claims 2-4, Richardson in view of Ramacier and Dabrowiak teaches the FDL of claim 1, but not further comprising wiring extending along a length of the FDL, wherein the proximal FDL connector is configured to fluidly, mechanically, and electrically connect with the TTM module, or wherein the one-or-more distal hub connectors are configured to fluidly, mechanically, and electrically connect with the one-or-more pad connectors respectively. Schaefer teaches an analogous FDL to that of Richardson including a quick release cord (900) for providing fluid and data communication between a thermal contrast therapy device and a treatment pad. Quick-release buttons (902, 904) on opposite ends of the extension cord respectively release prongs within the device-side fitting and the pad-side fitting, which snap into place over corresponding notches on the device interface fitting (210, 212 in FIG. 10) and the pad interface (1104, 1106 in FIG. 11). A data cable (906) runs between a data plug (908) configured to mate with a data fitting (214), and a pad ID reader (182 in FIGS. 9B-9C) embedded within the pad-side fitting (178). The data cable transmits data to a thermal contrast therapy device ((0117-0118]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Richardson to including the data cable of Schaefer in order to allow for the transmission of data to a thermal contrast therapy device ((0117-0118)]).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richardson, Ramacier and Dabrowiak as applied to claim 1 above, and further in view of US 2017/0135855 A1 to Stefan et al. (Stefan).
Regarding claim 14, , Richardson in view of Ramacier and Dabrowiak teaches the FDL of claim 1, but not wherein the authentication tag is configured to receive and store therapy information in memory thereof, the therapy information selected from date, time, duration, number of connections, number of thermal pads, TTM temperature and TTM flow rate. Stefan teaches an analogous device (title “Patient Warming System”) to that of Richardson including an authentication tag (RFID tag, [0052]) that may be time dated for a certain time period after which the tag will no longer be compatible with the reader to help ensure that the device comprising the tag will only be used for its intended lifetime ([0052]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the time dated information of the RFID to help ensure that the device will only be used for its intended lifetime.
Regarding claim 15, the combination teaches the FDL of claim 14 as well as Stefan teaching wherein the therapy information alters operation of the TTM module when received from the authentication tag ([0052] which states in part “the tag may be dated for a certain time period, for example, two year, and after two years the tag will no longer be compatible with the RFID reader.). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the time dated information of the RFID to help ensure that the device will only be used for its intended lifetime.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richardson in view of Ramacier, Dabrowiak and Schaefer.
Regarding claim 16, Richardson teaches a fluid delivery line (FDL) comprising a proximal FDL connector (Fig. 6 where 110 and 112 of 108 are connected to 104a) at a proximal point of the FDL configured to fluidly and mechanically connect with a targeted temperature management (TTM) module (Fig. 6), an FDL conduit (108) including a fluid delivery lumen (110) for transporting TTM fluid between the TTM module and a plurality of thermal-contact pads (Fig. 6), a fluid return lumen (112) in a side- by-side arrangement with the fluid delivery lumen (Fig. 4/Fig. 6) and a bifurcation in the FDL defining a pair of FDL conduit legs (Fig. 6) and a pair of distal manifold hubs (143) respectively coupled to the pair of FDL legs at a distal end of the FDL (Fig. 6), each distal manifold hub of the pair of distal manifold hubs includes a proximal hub connector (end of 143 that connects to 112 or 110 as in Fig. 6) configured to connect to a distal FDL connector (end of 112 or 110 that connects to 143 as in Fig. 6) at the distal end of the FDL (Fig. 6), each distal manifold hub configured for respectively connecting fluidly and mechanically to a plurality of pad connectors of the plurality thermal contact pads (Fig. 6).
However, Richardson in Fig.6 is silent with respect to each of the distal hub connector of the plurality of distal hub connectors including a displaceable member configured to engage or disengage a pad to hub latching mechanism to respectively secure or release a corresponding pad connector of the plurality pad connectors from the distal hub connector.
Richardson in Fig. 3 teaches a manifold hub (114) that includes quick connect couplings (144) that include an internal lock, that when the quick connect couplings are properly situated over and pressed down on the complimentary ports, the couplings are locked into fluid communication with the fluid supply/return. The quick connect couplings are removed by actuating a release (146) and when removed from a complementary port, a check valve in the quick connect coupling is closed to prevent fluid from leaking, and that although the invention is described using the particular quick connect coupling described, those of ordinary skill in the art will recognize that other quick connect couplings, which produce the same or similar results, may be used in additional embodiments ([0037]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the quick connect couplings in Fig. 3 of Richardson so as to allow for connection to the manifold and leak free disconnection as taught by Richardson ([0037)).
However, Richardson is silent with respect to the displaceable member being a button.
Ramacier teaches an analogous quick connect coupling valve assembly (title) to that of Richardson including wherein the displacement member is a button (81). It would have been obvious to one having ordinary skill in the art to have selected a button as taught by Ramacier as an obvious selection of one known actuating mechanism as an obvious matter of engineering design choice. This is especially true as Richardson teaches although the invention is described using the particular quick connect coupling described, those of ordinary skill in the art will recognize that other quick connect couplings, which produce the same or similar results, may be used in additional embodiments ([0037)).
However, Richardson is silent with respect to an authentication tag incorporated into the FDL, the authentication card including memory having stored thereon identification information, therapy information, or a combination thereof.
Dabrowiak teaches an analogous device (Fig. 1) to that of Richardson including a fluid delivery line (supply and return lines 16, 18) for transporting a targeted temperature management (TTM) fluid between a TTM module (system 12) and a treatment device (catheter 10). The device of Dabrowiak includes a near field communication (NFC) member associated with the heat exchange system and an NFC element associated with the heat exchange catheter line assembly to provide the processor with a signal representative of whether the NFC member detects the NFC element (abstract). The NFC member is configured to cause the NFC reader to determine that the line assembly is an assembly approved for use with the heat exchange system ([0008]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Richardson to include the NFC of Dabrowiak in order to allow for the communication of relevant use information at the time of connection as taught by Dabrowiak ([abstract and [0008, 0019-0021]).
However, Dabrowiak is silent with respect to the authentication tag specifically incorporated into the proximal FDL connector, the FDL conduit, a distal manifold hub of the pair of distal manifold hub connectors or a distal hub connector of the one-or-more distal hub connectors.
Given the teaching of Dabrowiak that it is advantageous to include an NFC member on the fluid delivery parts being connected to the heat exchange system to allow for the communication of relevant use information at the time of connection as taught by Dabrowiak ([abstract and [0008, 0019-0021]), it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have located the NFC as claimed to provide the relevant use information at the time of connection as an obvious matter of engineering design choice due to a lack of disclosed criticality or unexpected results. The motivation to do so can be found in Dabrowiak which discusses how the identification of connected parts benefits the use of the system ([abstract and [0008, 0019-0021]).
However, Richardson is silent with respect to the wherein the proximal FDL connector is configured to fluidly, mechanically, and electrically connect with the TTM module, or wherein the one-or-more distal hub connectors are configured to fluidly, mechanically, and electrically connect with the one-or-more pad connectors respectively.
Schaefer teaches an analogous FDL to that of Richardson including a quick release cord (900) for providing fluid and data communication between a thermal contrast therapy device and a treatment pad. Quick-release buttons (902, 904) on opposite ends of the extension cord respectively release prongs within the device-side fitting and the pad-side fitting, which snap into place over corresponding notches on the device interface fitting (210, 212 in FIG. 10) and the pad interface (1104, 1106 in FIG. 11). A data cable (906) runs between a data plug (908) configured to mate with a data fitting (214), and a pad ID reader (182 in FIGS. 9B-9C) embedded within the pad-side fitting (178). The data cable transmits data to a thermal contrast therapy device ((0117-0118]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Richardson to including the data cable of Schaefer in order to allow for the transmission of data to a thermal contrast therapy device ((0117-0118)]).
Regarding claim 17, the combination teaches the FDL of claim 16 as well as each connector including a sealing member configured to define a seal with a valve of the corresponding connector when secured together (abstract which states in part “A quick connection coupling valve assembly having a poppet member in both a male coupling member and a female coupling member, a fluid passageway defined therethrough is opened by engaging the poppet members of the male and female coupling members with each other, the fluid passageway is closed by releasing a spring member to disengage the poppet members from each other.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the sealing member of Ramacier so as to quickly lock and release the connection coupling valve without any fluid leakage which is a stated goal of Ramacier (Col. 1, lines 22-25).
Regarding claim 18, the combination teaches the FDL of claim 17 as well as Ramacier teaching wherein the valve is biased toward a closed state such that the valve of the corresponding connector automatically closes when the corresponding connector is disconnected (Col. 5, lines 22-42 which states in part “Therefore, the spring members 72,74 will bias the poppet members 62,64 forward when the tip ends 68,70 are disengaged from each other as is the case when the male coupling member 44 is disconnected from the female coupling member 46. Upon being biased forward, the poppet members 62,64 will close and seal the fluid passageways through the female and male coupling members 42,44, respectively.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have biased the valve to be closed so as to seal the fluid passageways once disengaged and prevent leakage of fluid which is a stated goal of Ramacier (Col. 1, lines 22-25).
Regarding claim 19, the combination teaches the FDL of claim 16 as well as Dabrowiak teaching wherein the authentication tag stores information in memory thereof, the identification information selected from a manufacturer’s identification ([0031, 0040]); product specific information including FDL model indication, an FDL part number, or a combination thereof; and manufacturing information including manufacturing date, lot number, or a combination thereof. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the identification information as taught by Dabrowiak so as to allow for the proper functioning of the device as taught by Dabrowiak such as preventing abnormal, unauthorized or unapproved connection to the system ([0027]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Richardson in view of Ramacier, Dabrowiak and Schaefer as applied to claim 1, and further in view of Stefan.
Regarding claim 20, Richardson in view of Ramacier, Dabrowiak and Schaefer teaches the FDL of claim 16, but not wherein the therapy information is selected from date, time, therapy duration, number of connections, number of thermal pads, TTM temperature and TTM flow rate. Stefan teaches an analogous device (title “Patient Warming System”) to that of Richardson including an authentication tag (RFID tag, [0052]) that may be time dated for a certain time period after which the tag will no longer be compatible with the reader to help ensure that the device comprising the tag will only be used for its intended lifetime ([0052]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have included the time dated information of the RFID to help ensure that the device will only be used for its intended lifetime.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794