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 filed May 29, 2026 has been entered. Applicant’s amendments have overcome the 112(b) rejections previously set-forth in the Non-Final Rejection mailed on 03/04/2026. Currently, claims 1-2, 4-5, 9-10, 15-16, 18, 20-21, and 25 have been amended, claims 3 and 19 have been cancelled, and claims 1-2, 4-18, 20-25 are pending in the application.
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, 6-7, 10-11, 13-14, 16-18, 20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone (U.S. Application No. 20160287433 A1), and further in view of Hirsch (U.S. Patent No. 5542916 A).
Regarding independent claim 1, Mazzone discloses a targeted temperature management (TTM) system (10) (pa. 0001 & Fig. 1), comprising:
a TTM module (14) configured to provide a TTM fluid (via pump ‘P’) (pa. 0014-0015);
a thermal pad (18) configured to receive the TTM fluid from the TTM module to facilitate thermal energy transfer between the TTM fluid and a patient (16) (pa. 0015);
a fluid delivery line (FDL) (L3) extending between the TTM module and the thermal pad, the FDL configured to provide TTM fluid flow between the TTM module and the thermal pad (pa. 0015); and
a temperature sensing medical instrument (12) configured to be inserted into the patient and obtain temperature data indicating a temperature of blood of the patient (pa. 0005, 0020-0021), the temperature sensing medical instrument comprising:
a housing (34) configured to remain external the patient (see Fig. 2);
an elongate portion (32) extending distally from the housing configured to be inserted into the patient (pa. 0017, 0021 & Figs. 2-3); and
a temperature sensing unit (30) (pa. 0021-0022);
wherein the temperature sensing medical instrument is further configured to communicatively couple to the TTM module (via temperature connector 40) and provide the TTM module with temperature feedback including the temperature of the blood of the patient (pa. 0019).
However, Mazzone does not disclose the temperature sensing unit being disposed at a distal tip of the elongate portion.
Hirsch, in the same field of endeavor, teaches a flexible catheter (10) attached to a control unit (12) by means of a connector (14) (Col. 3, lines 43-47 & Fig. 1). The flexible catheter includes a distal tip (16) comprising a temperature sensor (42) mounted near tapered tip (30) (Col. 3, lines 66-67 – Col. 4, lines 1-2 & Fig. 2).
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 location of the temperature sensing unit of Mazzone to be disposed at the distal tip of the elongate portion, as taught by Hirsch, since applicant has not disclosed that the specific location of the temperature sensing unit solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the temperature sensing unit being located either proximal to/at a distal location of the tip of the elongate portion given that in both designs choices would yield the same predictable results of measuring temperature.
Regarding claim 2, Mazzone/Hirsch combination discloses wherein the temperature sensing unit comprises a thermistor (Mazzone, pa. 0023).
Regarding claims 4, 11, and 20, Mazzone discloses the invention substantially as claimed in claim 1 discussed above.
However, Mazzone does not disclose wherein the housing is configured to receive a catheter such that the elongate portion extends through the catheter.
Hirsch, in the same field of endeavor, teaches an elongate portion (10), a housing (12), and a catheter (14), wherein the housing is configured to receive a catheter such that the elongate portion extends through the catheter (Col. 3, lines 43-45 & Fig. 1).
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 incorporated the catheter to the medical instrument of Mazzone since applicant has not disclosed that the catheter structure solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with or without the catheter component.
Regarding claim 6, Mazzone/Hirsch combination discloses wherein communicative coupling is established through establishing a connection between the TTM module and the temperature sensing medical instrument via one or more electrical wires (40) (Mazzone, pa. 0019).
Regarding claim 7, Mazzone/Hirsch combination discloses wherein the communicative coupling is established through establishing a wireless connection between the TTM module and the temperature sensing medical instrument in accordance with a short-range wireless technology standard (Mazzone, pa. 0019).
Regarding independent claim 10, Mazzone discloses a temperature sensing medical instrument (12) configured to be inserted into a patient (16) and obtain temperature data indicating a temperature of blood of the patient (pa. 0005, 0020-0021 & Fig. 1), the temperature sensing medical instrument comprising:
a housing (34) configured to remain external the patient (see Fig. 2);
an elongate portion (32) extending distally from the housing and configured to be inserted into the patient (pa. 0017 & Figs. 2-3); and
a thermistor (30) (pa. 0017, 0023), wherein the temperature sensing medical instrument is configured to communicatively couple with a targeted temperature management (TTM) module (14) of a TTM system (14) and provide the TTM module with the temperature data (pa. 0001, 0014-0015).
However, Mazzone does not disclose the thermistor being disposed at a distal tip of the elongate portion.
Hirsch, in the same field of endeavor, teaches a flexible catheter (10) attached to a control unit (12) by means of a connector (14) (Col. 3, lines 43-47 & Fig. 1). The flexible catheter includes a distal tip (16) comprising a temperature sensor (42) mounted near tapered tip (30) (Col. 3, lines 66-67 – Col. 4, lines 1-2 & Fig. 2).
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 location of the thermistor of Mazzone to be disposed at the distal tip of the elongate portion, as taught by Hirsch, since applicant has not disclosed that the specific location of the thermistor solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the thermistor being located either proximal to/at a distal location of the tip of the elongate portion given that in both designs choices would yield the same predictable results of measuring temperature.
Regarding claim 13, Mazzone/Hirsch combination discloses wherein communicative coupling is established through a physical connection between the TTM module and the temperature sensing medical instrument via one or more electrical wires (40) (Mazzone, pa. 0019).
Regarding claim 14, Mazzone/Hirsch combination discloses wherein communicative coupling is established through a wireless connection between the TTM module and the temperature sensing medical instrument in accordance with a short-range wireless technology standard (Mazzone, pa. 0019).
Regarding independent claim 16, Mazzone discloses a method of using a targeted temperature management (TTM) system (10) (pa. 0005, 0014-0015 & Fig. 1), comprising:
providing a TTM system comprising:
a TTM module (14) configured to provide a TTM fluid (via pump ‘P’) (pa. 0001, 0014-0015),
a thermal pad (18) configured to receive the TTM fluid from the TTM module to facilitate thermal energy transfer between the TTM fluid and a patient (16) (pa. 0015),
a fluid delivery line (FDL) (13) extending between the TTM module and the thermal pad, the FDL configured to provide TTM fluid flow between the TTM module and the thermal pad (pa. 0015), and
a temperature sensing medical instrument (12) configured to be inserted into the patient and obtain temperature data indicating a temperature of blood of the patient (pa. 0017, 0020-0021 & Fig. 2), the temperature sensing medical instrument comprising:
a housing (34) configured to remain external the patient (see Fig. 2);
an elongate portion (32) extending distally from the housing and configured to be inserted into the patient (pa. 0017, 0021 & Figs. 2-3); and
a temperature sensing unit (30) (pa. 0021-0022), wherein the temperature sensing medical instrument is further configured to communicatively couple to the TTM module (via temperature connector 40) and provide the TTM module with temperature feedback including the temperature of the blood of the patient (pa. 0019);
applying the thermal pad to the patient (pa. 0015);
inserting the temperature sensing medical instrument into the patient (pa. 0020-0021);
delivering the TTM fluid from the TTM module to the thermal pad (pa. 0015);
receiving, by the TTM module, the temperature data (via temperature connector 40) from the temperature sensing medical instrument (pa. 0019); and
analyzing an efficacy a TTM procedure being performed by the TTM system based on the temperature data, wherein the TTM procedure includes providing the TTM fluid (pa. 0016).
However, Mazzone does not disclose the temperature sensing unit being disposed at a distal tip of the elongate portion.
Hirsch, in the same field of endeavor, teaches a flexible catheter (10) attached to a control unit (12) by means of a connector (14) (Col. 3, lines 43-47 & Fig. 1). The flexible catheter includes a distal tip (16) comprising a temperature sensor (42) mounted near tapered tip (30) (Col. 3, lines 66-67 – Col. 4, lines 1-2 & Fig. 2).
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 location of the temperature sensing unit of Mazzone to be disposed at the distal tip of the elongate portion, as taught by Hirsch, since applicant has not disclosed that the specific location of the temperature sensing unit solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the temperature sensing unit being located either proximal to/at a distal location of the tip of the elongate portion given that in both designs choices would yield the same predictable results of measuring temperature.
Regarding claim 17, Mazzone/Hirsch combination discloses wherein the TTM module includes a processor (20) and a non-transitory, computer-readable medium (26) having stored thereon logic (Mazzone, pa. 0016) that, when executed by the processor, is configured to cause performance of operations including:
receiving the temperature data (Mazzone, pa. 0016),
analyzing an efficacy a TTM procedure being performed by TTM system based on the temperature data (by making a comparison between the received patient temperature data to instructions on the computer-readable medium), wherein the TTM procedure includes providing the TTM fluid, and
altering the TTM procedure based on the analyzing (by controlling the pump, refrigerant compressor 22, and/or bypass valve 24) (Mazzone, pa. 0016).
Regarding claim 18, Mazzone/Hirsch combination discloses wherein the temperature sensing unit comprises a thermistor (Mazzone, pa. 0017, 0023).
Regarding claim 22, Mazzone/Hirsch combination discloses wherein communicative coupling is established through establishing a connection between the TTM module and the temperature sensing medical instrument via one or more electrical wires (40) (Mazzone, pa. 0019).
Regarding claim 23, Mazzone/Hirsch combination discloses wherein the communicative coupling is established through establishing a wireless connection between the TTM module and the temperature sensing medical instrument in accordance with a short-range wireless technology standard (Mazzone, pa. 0019).
Claims 5, 12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone and Hirsch as applied to claims 1, 10, and 16 above, and further in view of Allers (W.O. Application No. 03066137 A1).
Regarding claims 5, 12, and 21, Mazzone/Hirsch combination discloses wherein the thermistor is configured to be disposed within blood vessel of the patient upon insertion (pa. 0005).
However, they do not explicitly disclose disposing the thermistor within an internal jugular (IJ) vein, wherein the temperature data obtained when the thermistor is within the IJ vein is indicative of a temperature of a brain of the patient.
Allers, in the same field of endeavor, teaches a method and a catheter device for monitoring, controlling, and maintaining the temperature of the brain (page 10, last paragraph), wherein the catheter device comprises a thermistor introduced to an internal jugular vein (step 1208) in order to more accurately reflect the temperature of the brain (page 16, lines 16-24; page 17, lines 8-14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have disposed the thermistor of Mazzone in the IJ vein, as taught by Allers, for the purpose of accurately reflecting the temperature of the brain in order to closely monitor cerebral health.
Claims 8, 15, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone and Hirsch as applied to claims 1, 10, and 16 above, in view of Carson (W.O. Application No. 2003030790 A1), and further in view of Calderon (U.S. Application No. 20170071783 A1).
Regarding claims 8, 15, and 24, Mazzone discloses wherein the temperature sensing medical instrument includes a processor (20) (pa. 0016).
Examiner is interpreting the “includes” language as being mechanically and/or electrically attached to. The claim language is broad and does not specify the processor, the A/D converter, nor the battery need to be physically disposed inside of the temperature sensing medical instrument.
However, Mazzone/Hirsch combination do not disclose the temperature sensing medical instrument includes an analog-to-digital converter.
Carson, in the same field of endeavor, teaches a temperature control system (10) comprising a controller, or microprocessor (130), operably interconnected to the various noted sensors via a signal-conditioning interface (140), wherein the microprocessor includes an analog to digital converter to convert the conditioned signals into digital signals for processing (page 21, lines 1-8).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated the signal-conditioning interface of Carson into the TTM system of Mazzone in order to cleanly translate signals from the thermistor into a standardized format suitable for processing, and it would have been obvious to have incorporated the analog-to-digital converter into the processor of Mazzone in order to convert the sensed signals into digital format that can be stored, manipulated, and transmitted.
However, Mazzone/Hirsch/Carson combination do not teach the temperature sensing medical instrument including a battery.
Calderon, in the same field of endeavor, teaches a system for local thermal treatment that provides heating or cooling to a part of the body of a subject (pa. 0009), wherein the system includes a rechargeable battery (215) that provides power to system and improves the portability of system (pa. 0016).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the battery of Calderon into the TTM system of Mazzone in order to provide remote usage to the user.
Claims 9 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone and Hirsch as applied to claims 1 and 16 above, and further in view of Carson (W.O. Application No. 2003030790 A1).
Regarding claim 9, Mazzone/Hirsch combination discloses wherein the TTM module includes a processor (20) and a non-transitory, computer-readable medium (26) having stored thereon logic (Mazzone, pa. 0016) that, when executed by the processor, is configured to cause performance of operations including:
receiving the temperature data (pa. 0016),
analyzing an efficacy of a TTM procedure based on the temperature data (by making a comparison between the received patient temperature data to instructions on the computer-readable medium), wherein the TTM procedure includes providing the TTM fluid, and altering the TTM procedure based on the analyzing (by controlling the pump, refrigerant compressor 22, and/or bypass valve 24) (Mazzone, pa. 0016).
However, they do not disclose wherein altering the TTM procedure comprises providing the TTM fluid at a temperature determined by a trained machine learning model, wherein the trained machine learning model is configured to provide an output indicating the temperature based on the temperature data and one or more of patient information, a desired temperature of the patient, or a desired time for the TTM procedure.
Calderon, in the same field of endeavor, teaches a temperature control system (10) (page 15, lines 25-27) comprising a microprocessor (130), operably interconnected to a temperature sensor (70) (page 24, lines 26-30). The microprocessor utilizes control algorithms/trained machine learning models and associated preset/user- defined control limits/ranges stored in a memory (132) to maintain a particular patient temperature set point (page 21, lines 10-13). As seen in Figure 4, the temperature control algorithm employed determines the power to be applied to the circulating fluid such that the fluid temperature rapidly approaches and then remains close to the desired set point temperature. The temperature control algorithm is further configured to reduce significant temperature oscillations around the selected patient temperature set point and is capable of changing the fluid temperature in a rapid manner when one or more of the monitored temperatures of the system are outside a preset range (page 27, lines 7-14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the trained machine learning model of Calderon which provides an output indicating a temperature based on the temperature data from the temperature sensor and a desired temperature of the patient to the TTM system of Mazzone for the purpose of providing a closed feedback system that is more accurate given that it uses multiple parameters to confirm the desired TTM fluid temperature that is appropriate for a case-by-case basis.
Regarding claim 25, Mazzone discloses wherein the TTM module includes a processor (20) and a non-transitory, computer-readable medium (26) having stored thereon logic (pa. 0016) that, when executed by the processor, is configured to cause performance of operations including:
receiving the temperature data (pa. 0016),
analyzing an efficacy of a TTM procedure being performed by the TTM system based on the temperature data (by making a comparison between the received patient temperature data to instructions on the computer-readable medium), wherein the TTM procedure includes providing the TTM fluid, and altering the TTM procedure based on the analyzing (by controlling the pump, refrigerant compressor 22, and/or bypass valve 24) (pa. 0016).
However, they do not disclose wherein altering the TTM procedure comprises providing the TTM fluid at a temperature determined by a trained machine learning model, wherein the trained machine learning model is configured to provide an output indicating the temperature based on the temperature data and one or more of patient information, a desired temperature of the patient, or a desired time for the TTM procedure.
Calderon, in the same field of endeavor, teaches a temperature control system (10) (page 15, lines 25-27) comprising a microprocessor (130), operably interconnected to a temperature sensor (70) (page 24, lines 26-30). The microprocessor utilizes control algorithms/trained machine learning models and associated preset/user- defined control limits/ranges stored in a memory (132) to maintain a particular patient temperature set point (page 21, lines 10-13). As seen in Figure 4, the temperature control algorithm employed determines the power to be applied to the circulating fluid such that the fluid temperature rapidly approaches and then remains close to the desired set point temperature. The temperature control algorithm is further configured to reduce significant temperature oscillations around the selected patient temperature set point and is capable of changing the fluid temperature in a rapid manner when one or more of the monitored temperatures of the system are outside a preset range (page 27, lines 7-14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the trained machine learning model of Calderon which provides an output indicating a temperature based on the temperature data from the temperature sensor and a desired temperature of the patient to the TTM system of Mazzone for the purpose of providing a closed feedback system that is more accurate given that it uses multiple parameters to confirm the desired TTM fluid temperature that is appropriate for a case-by-case basis.
Response to Arguments
Applicant’s arguments, see pages 8-12, filed 05/29/2026, with respect to the 102 rejection of claims 1, 10, and 16 under Mazzone have been fully considered and are persuasive. Specifically, Applicant’s amendments to claims 1, 10, and 16 to further require the temperature sensing unit/thermistor to be disposed at a distal tip of the elongate portion is defined over Mazzone given that it does not contemplate this claimed structure. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-2, 4, 6-7, 10-11, 13-14, 16-18, 20, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone (U.S. Application No. 20160287433 A1), and further in view of Hirsch (U.S. Patent No. 5542916 A).
Claims 5, 12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone and Hirsch as applied to claims 1, 10, and 16 above, and further in view of Allers (W.O. Application No. 03066137 A1).
Claims 8, 15, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone and Hirsch as applied to claims 1, 10, and 16 above, in view of Carson (W.O. Application No. 2003030790 A1), and further in view of Calderon (U.S. Application No. 20170071783 A1).
Claims 9 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone and Hirsch as applied to claims 1 and 16 above, and further in view of Carson (W.O. Application No. 2003030790 A1).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
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.
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/A.V.G./Examiner, Art Unit 3794 /Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
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