DETAILED ACTION
This action is pursuant to the claims filed on 11/13/2024. Claims 1-3, 6-7, 9-14, 17-18, 20, 22, 29, 31-32, and 90-91 are pending. A first action on the merits of claims 1-3, 6-7, 9-14, 17-18, 20, 22, 29, 31-32, and 90-91 is as follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/23/2025, 01/30/2025, 08/30/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 6-7, 9-10, 12-14, 17-18, 20, 22, and 91 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson (U.S. PGPub No. 2009/0099629) in view of Dabrowiak (U.S. PGPub No. 2019/0151143).
Regarding claim 1, Carson teaches a temperature management system for controlling a temperature of a body of a patient (see Fig 1-2), the system comprising: a heat exchange device configured to deliver a temperature management treatment to the patient (Fig 1 thermal exchanger 30 and thermal exchange medium 40), the temperature management treatment based on circulation of a coolant (Fig 1 thermal exchange medium 40); an extracorporeal control console coupled to the heat exchange device and configured to circulate coolant and generate coolant temperature data representing a temperature of the coolant during the temperature management treatment (Fig 1 user interface 10 and control module 20; Fig 3B showing water temperature); at least one sensor coupled to the extracorporeal control console and configured to generate a patient temperature data indicative of a temperature of the body of the patient (Fig 1-2, temp sensor 60 and 50); a processor, a memory storing instructions, and associated circuitry communicatively coupled to the sensor (Fig 1 and [0012] disclosing processing of module 20, storage capabilities, and circuitry for sensor 60 and module 20/interface 10 to communicate), wherein the processor is configured to: receive the patient temperature data from the sensor (Fig 1 at lest signals 64, 14, 12); receive the coolant temperature data from the extracorporeal control console (Fig 1 at lest signals 64, 14, 12); determine a power value representing cooling or warming power delivered to the patient based on a relationship between the patient temperature data and the coolant temperature data (Fig 3B and [0054], “the system is operating at pre-set maximum rate”, such that the power value is implicitly determined representing a maximum cooling power based on patient and coolant temperature data as shown in at least Fig 3D showing patient temperature plot 252 and coolant temperature plot 262).
Carson fails to teach wherein the relationship comprises a ratio representing a fraction of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient; and generate and display the power value as a percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient.
In related prior art, Dabrowiak teaches wherein the relationship comprises a ratio representing a fraction of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient (Fig 17, “warming effort” and “cooling effort” widget showing the power as a fraction of a maximum cooling or warming power); and generate and display the power value as a percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient (Fig 17 shows display with power value as a percentage of the maximum cooling or warming power capability). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Carosn in view of Dabrowiak to incorporate the generating and display of the power value as a ratio representing a fraction of the maximum cooling or warming power and displaying the power value as a percentage to arrive at claim 1. Doing so would advantageously enable the system to display “the percentage of the system’s maximum warming or cooling capability” to inform the user(s) of the treatment protocol in progress (Dabrowiak [0193]).
Regarding claim 6, in view of the combination of claim 1 above, Dabrowiak further teaches wherein when a working fluid pump of the extracorporeal control console is on, a value of the ratio is based on the coolant temperature data and the patient temperature data (Fig 17 showing a rate of cooling which is based on the patient temp and target temp and [0082-0087] disclosing a power calculation including flow rate and coolant temperature).
Carson/Dabrowiak discloses substantially all the limitations of the claim(s) except the value of the ratio being based solely on the coolant temperature data and patient temperature data. 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 value of the ratio based solely on the coolant temperature data and patient temperature data, since applicant has not disclosed that the value of the ratio being solely based on the coolant temperature data and patient temperature data solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with the power value ratio being based on further parameters such as coolant flow rate as disclosed by Dabrowiak.
Regarding claim 7, in view of the combination of claim 1 above, Dabrowiak further teaches wherein the ratio is further based on a speed of a working fluid pump of the extracorporeal control console ([0082]-[0087], power is based at least in part on pump rotational speed; for example, a working fluid pump with a speed of 0 (i.e., turned off) would yield a power value ratio of 0).
Regarding claim 9, in view of the combination of claim 1 above, Dabrowiak further teaches wherein the ratio is further based on a power consumption of the extracorporeal control console (Fig 17 warming or cooling effort ratio is necessarily based at least in part on a power consumption of the extracorporeal control console 14 to pump warming/cooling thermal exchange fluid).
Regarding claim 10, in view of the combination of claim 1 above, Dabrowiak further teaches a user interface configured to display a visual representation of the data representing the percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient (See Fig 17).
Regarding claim 12, in view of the combination of claim 1 above, Dabrowiak further teaches wherein a visual representation of the data representing the percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient comprises a linear meter (see Fig 17).
Regarding claim 13, in view of the combination of claim 1 above, Carson further teaches wherein the a user interface is further configured to display a representation of operational data for one or more periods of the temperature management treatment of the patient, the operational data representing operation of at least a portion of the heat exchange device or the extracorporeal control console (Figs 3B-D shows display of multiple phases of the treatment representing operation of the heat exchange device).
Regarding claim 14, in view of the combination of claim 13 above, Carson further teaches wherein the representation of operational data for one or more periods of the temperature management treatment of the patient comprises a treatment log representing operational data for multiple periods of the temperature management treatment of the patient (Figs 3B-D shows display of multiple phases of the treatment representing operation of the heat exchange device).
Regarding claim 17, in view of the combination of claim 13 above, Carson further teaches wherein the representation of operational data for one or more periods of the temperature management treatment of the patient comprises a sequence of symbols, each symbol of the sequence representing a log entry (Fig 3B-D, phases 1-3 define sequence of symbols on bottom half of interface; furthermore, each dashed line of graph 214 represent a sequence of symbols for the treatment)
Regarding claim 18, in view of the combination of claim 14 above, Carson further teaches wherein a log entry of the treatment log includes data representing one or more of a cooling or warming rate applied during a treatment period, a target patient temperature value (Fig 3D patient target 232), a patient temperature value (Figs 3B-D patient temperature value on display), a system mode during a treatment period, a time period associated with a treatment period (Figs 3B-D remaining time widget as well as x-axis of graph 214), whether the temperature management system is operating to lower, raise or maintain the temperature of the body of the patient during a treatment period (slope of graph 214 conveys this information), and a position of a treatment period relative to one or more other treatment periods for the temperature management treatment of the patient.
Regarding claim 20, Carson teaches a temperature management system for controlling a temperature of a body of a patient (see Fig 1-2), the system comprising: a heat exchange device configured to deliver a temperature management treatment to the patient (Fig 1 thermal exchanger 30 and thermal exchange medium 40), the temperature management treatment based on circulation of a coolant (Fig 1 thermal exchange medium 40); an extracorporeal control console coupled to the heat exchange device and configured to generate operational data, the operational data comprising coolant temperature data representing a coolant temperature of the coolant during the temperature management treatment (Fig 1 user interface 10 and control module 20; Fig 3B showing water temperature); one or more sensors coupled to the extracorporeal control console and configured to generate patient temperature data indicative of a temperature of the body of the patient (Fig 1-2, temp sensor 60); a user interface that is coupled to the extracorporeal control console (Fig 1 user interface 10); and a processor, a memory storing instructions, and associated circuitry communicatively coupled to the user interface and the one or more sensors (Fig 1 and [0012] disclosing processing of module 20, storage capabilities, and circuitry for sensor 60 and module 20/interface 10 to communicate), wherein the processor is configured to: receive the patient temperature data from the one or more sensors (Fig 1 at lest signals 64, 14, 12); receive coolant temperature data representing a coolant temperature (Fig 1 at lest signals 64, 14, 12); determine a power value representing cooling or warming power delivered to the patient based on a relationship between the patient temperature data and the coolant temperature data ((Fig 3B and [0054], “the system is operating at pre-set maximum rate”, such that the power value is implicitly determined representing a maximum cooling power based on patient and coolant temperature data as shown in at least Fig 3D showing patient temperature plot 252 and coolant temperature plot 262); generate at least one treatment log based on the operational data and the patient temperature data (Figs 3B-F, graphic display region 214 shows treatment log of patient temperature data 252 and coolant temperature data 262); wherein the treatment log includes multiple log entries associated with respective periods of the temperature management treatment (Fig 3B-F graphic display region 214 comprises multiple log entries associated with respective periods of the treatment). Examiner further notes the user interface of Carson involves the simultaneous presentation of different types of data (Figs 3B-F, 4B-C each presenting multiple types of data simultaneously).
Carson fails to teach wherein the relationship comprises a ratio representing a fraction of maximum cooling or warming power capability of the temperature management system to cool or warm the patient; and cause the user interface to simultaneously present the power value and the treatment log.
In related prior art, Dabrowiak teaches wherein the relationship comprises a ratio representing a fraction of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient (Fig 17, “warming effort” and “cooling effort” widget showing the power as a fraction of a maximum cooling or warming power); and cause the user interface to simultaneously present the power value and the treatment log (Fig 17 shows display with power value as a ratio of the maximum cooling or warming power capability simultaneously with a treatment log below). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Carosn in view of Dabrowiak to incorporate the generating and display of the power value as a ratio representing a fraction of the maximum cooling or warming power and displaying the power value simultaneously with the treatment log to arrive at claim 20. Doing so would advantageously enable the system to display “the percentage of the system’s maximum warming or cooling capability” to inform the user(s) of the treatment protocol in progress (Dabrowiak [0193]).
Regarding claim 22, in view of the combination of claim 20 above, Carson further teaches wherein the operational data comprises one or more of a target patient temperature, a system mode (Figs 3B-D shows system mode by which phase is active), a pump speed, and a cooling or warming rate, and wherein the log entries or treatment periods of the treatment log are ranked in order of occurrence (Figs 3B-D graph 214 display treatment periods in order of occurrence based on the x-axis).
Regarding claim 91, in view of the combination of claim 1 above, Carson further teaches wherein the patient temperature data represents a measured or current temperature of the body of the patient (Fig 3C patient temperature plot 252 as well as “Patient Temperature” display on left side of graph).
Carson fails to teach the power value is the percentage of the maximum cooling or warming power capability of the temperature management system at the measured or current temperature.
Dabrowiak further teaches the power value is the percentage of the maximum cooling or warming power capability of the temperature management system at the measured or current temperature (See Fig 17 showing power value at measured patient temperature). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Carosn in view of Dabrowiak to incorporate the generating and display of the power value as a ratio representing a fraction of the maximum cooling or warming power and displaying the power value as a percentage to arrive at claim 91. Doing so would advantageously enable the system to display “the percentage of the system’s maximum warming or cooling capability” to inform the user(s) of the treatment protocol in progress (Dabrowiak [0193]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Dabrowiak, and in further view of Rajagopalan (U.S. PGPub No. 2015/0138205).
Regarding claim 11, in view of the combination of claim 1 above, Dabrowiak further teaches wherein a visual representation of the data representing the percentage of the maximum cooling or warming power capability of the temperature management system to cool or warm the patient comprises an arcuate meter (see Fig 17).
Dabrowiak fails to teach the meter as arcuate.
In related prior art, Rajagopalan discloses a system with various graphical displays of physiological parameters including an arcuate meter (see Fig 3, 5, 7-8, 11-12, 15, 17).
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 Carson in view of Dabrowiak and Rajagopalan to incorporate an arcuate meter, since applicant has not disclosed that meter specifically being arcuate solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with any form of meter that represents the percentage of maximum cooling or warming capability of the system to warm or cool the patient.
Claim(s) 29, 31-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Dabrowiak, and in further view of Dabrowiak-2 (U.S. PGPub No. 2014/0172050).
Regarding claim 29, in view of the combination of claim 20 above.
Carson fails to teach the processor further configured to generate digital output data including a predefined format that enables the digital output data to be streamed to a remote device.
In related prior art, Dabrowiak-2 teaches the processor further configured to generate digital output data including a predefined format that enables the digital output data to be streamed to a remote device ([0026]). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Carson in view of Dabrowiak and Dabrowiak-2 to incorporate the processor configured to generate the digital output data with a predefined format to be streamed to a remote device to arrive at claim 29. Doing so would advantageously enable the temperature management treatment to be monitored from a remote system and location ([0026]).
Regarding claims 31-32, in view of the combination of claim 29 above.
Carson fails to teach wherein the processor is configured to cause the digital output data to be streamed to the remote device in real time or in near real time during the temperature management treatment; wherein the predefined format is configured to enable the remote device to parse the digital output data for displaying the patient data and/or the operational data upon receiving the digital output data.
Dabrowiak-2 further teaches wherein the processor is configured to cause the digital output data to be streamed to the remote device in real time or in near real time during the temperature management treatment ([0026] discloses streaming digital output data in at least near real time relating to the sensed temperature data); wherein the predefined format is configured to enable the remote device to parse the digital output data for displaying the patient data and/or the operational data upon receiving the digital output data ([0026] disclosing parsing digital data to display sensed temperature information and operation of the system information to a remote display). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Carson in view of Dabrowiak and Dabrowiak-2 to incorporate the processor configured to generate the digital output data with a predefined format to be streamed to a remote device to arrive at claims 31-32. Doing so would advantageously enable the temperature management treatment to be monitored from a remote system and location ([0026]).
Claim(s) 90 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson in view of Dabrowiak, and in further view of Zarins (U.S. PGPub No. 2008/0255642).
Regarding claim 90, in view of the combination of claim 1 above. Carson teaches the use of alarms and setting alarm condition data ([0064]).
Carson fails to teach wherein the processor is configured to provide an alert or prompt in response to the system exceeding a power value threshold.
In related prior art, Zarins teaches a similar system wherein a is configured to provide an alert or prompt in response to the system exceeding a power value threshold ([0168] and claim 135 of PGPub “issuing an alarm when the maximum power threshold is reached or an interlock condition has been satisfied.”). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor of Carson in view of Dabrowiak and Zarins to incorporate the alert in response to the system exceeding a power value threshold to arrive at claim 90. Doing so would advantageously enable the system to police itself to ensure the power level does not exceed a maximum threshold to ensure safety of the patient ([0168]).
Allowable Subject Matter
Claims 2-3 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claims 2-3, the Carson, Dabrowiak, Dabrowiak-2, Zarins, Rajagopalan references fail to teach the determination of the ratio of the power value as respectively claimed in claims 2-3. Dabrowiak discloses a warming and cooling effort meter based on a percentage but fails to explicitly disclose how said value is calculated. Paragraph [0082] discloses an equation for determining a power that is based on the coolant temperature and flow rate, but does not read upon the instant claims. The Carson reference similarly fails to contemplate a cooling or warming effort ratio calculation. Likewise, the remaining references of record fail to disclose or contemplate the formula as claimed. Therefore, any combination of the references of record to arrive at claims 2 or 3 would necessarily rely upon impermissible hindsight benefit using information solely gleaned from the applicant’s specification. No other pertinent prior art reference were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claim(s) 2-3.
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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