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 preliminary Amendments filed May 30, 2024 has been entered. Currently, claims 3, 9-10, 19, and 25 have been amended, and claims 1-25 are pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9, 16-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation “TTM system” in line 6. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this TTM system are different from the TTM system already recited in claim 1, or if they are all the same system. For examination purposes, Examiner will treat all TTM systems as being the same system.
Claim 16 recites the limitation "providing a TTM system" in line 3, and “TTM system” in line 15 of page 9. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether these TTM systems are different from the TTM system previously recited in the same claim, or if they are all the same system. For examination purposes, Examiner will treat all TTM systems as being the same system. Claims 17-24 are also rejected because they are dependent on claim 16.
Claim 16 recites the limitation "delivering TTM fluid" in line 12 of page 9. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this TTM fluid is different from the TTM fluid previously recited in the same claim, or if they are the same system. For examination purposes, Examiner will treat both TTM fluids as being the same fluid. Claims 17-24 are also rejected because they are dependent on claim 16.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 6-7, 9-10, 13-14, 16-19, 22-23, and 25 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mazzone (U.S. Application No. 20160287433 A1).
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 (15) (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), 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).
Regarding claim 2, Mazzone discloses wherein the temperature sensing medical instrument includes a thermistor (pa. 0017 & Fig. 2).
Regarding claim 3, Mazzone discloses wherein the temperature sensing medical instrument includes a housing (34) and an elongate portion (32) extending distally from the housing, wherein the thermistor is disposed along or at a distal tip of the elongate portion (pa. 0017 & Figs. 2-3).
Regarding claim 6, Mazzone 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) (pa. 0019).
Regarding claim 7, Mazzone 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 (pa. 0019).
Regarding claim 9, 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 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) (pa. 0016).
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;
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 disposed along or at a distal tip of the elongate portion (pa. 0017), 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).
Regarding claim 13, Mazzone 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) (pa. 0019).
Regarding claim 14, Mazzone 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 (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 (15) (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), 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 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 TTM system based on the temperature data, wherein the TTM procedure includes providing the TTM fluid (pa. 0016).
Regarding claim 17, 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 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) (pa. 0016).
Regarding claim 18, Mazzone discloses wherein the temperature sensing medical instrument includes a thermistor (pa. 0017 & Fig. 2).
Regarding claim 19, Mazzone discloses wherein the temperature sensing medical instrument includes a housing (34) and an elongate portion (32) extending distally from the housing, wherein the thermistor is disposed along or at a distal tip of the elongate portion (pa. 0017 & Figs. 2-3).
Regarding claim 22, Mazzone 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) (pa. 0019).
Regarding claim 23, Mazzone 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 (pa. 0019).
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 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) (pa. 0016).
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 4, 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone as applied to claims 1, 10, and 16 above, and further in view of Hirsch (U.S. Patent No. 5542916 A).
Regarding claim 4, Mazzone discloses the invention substantially as claimed in claims 1, and 3 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 a medical device comprising 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 11 and 20, Mazzone discloses the invention substantially as claimed in claim 10 and 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 a medical device comprising 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 20, Mazzone discloses the invention substantially as claimed in claims 16 and 19 and 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 a medical device comprising 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.
Claims 5, 12, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Mazzone 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 discloses wherein the thermistor is configured to be disposed within blood vessel of the patient upon insertion (pa. 0005).
However, Mazzone does 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 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 does 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/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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Callister (US 20150025411 A1) teaches analyzing an efficacy a TTM procedure being performed by TTM system based on the temperature data, wherein the TTM procedure includes providing the TTM fluid, and altering the TTM procedure based on the analyzing (pa. 0046).
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794