DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure (IDS) submitted on 02/02/2022 has been considered by the examiner.
Claim Status
A complete action on the merits of claims 58-77 follows below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "88" and "18" have both been used to designate “heat exchanger”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “88” has been used to designate both “ram” and “heat exchanger.”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
In paragraph [0045] “heat exchanger 32” should recite –extracorporeal heat exchanger 32” .
Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim 69 is rejected on the grounds of non-statutory double patenting as being unpatentable over claims 1 of U.S Patent No. 11,253,392 and in further view of Brian (Pub. No. 2007/0043409).
Regarding claim 69, claim 1 of Patent ‘392 teaches all the limitations expect that it does not teach a first sensor configured to sense a body temperature of the subject and configured to be disposed in or on the subject the controller configured to receive one or more signals from the first sensor indicating the body temperature of the subject
However, Brian teaches [0040] [0044] body temperature measuring apparatus 17; (e.g., a catheter or wire having a temperature sensor that is advanceable out of the distal tip of the catheter 12 or shaft 21 and useable for sensing the temperature of the subject's flowing blood. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to for a sensor that senses a body temperature of the subject wherein the controller receives signals from the first sensor , for the purposes of adjusting cooling based on body temperature.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 58-60, 63-64, 67, 69-72, and 74-77 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brian (Pub. No. 2007/0043409) in view of Rozenberg (Pub. No. 2009/0234325), and in further view of Kasza (Pub. No. 2007/0056313).
Regarding claim 58, Brian teaches a system for cooling a subject to a target temperature (heat exchange catheter system 10) comprising:
a heat exchange catheter including an inflow lumen (12, Fig. 1, inflow tube 43), a heat exchanger configured to exchange heat with blood flowing through a blood vessel (intracorporeal heat exchanger 28), and an outflow lumen (outflow tube 45), the heat exchange catheter configured to receive a heat exchange medium through the inflow lumen, the heat exchanger, and the outflow lumen ([0044] Thermal exchange fluid is thus pumped from the inner tube 32 of the extracorporeal heat exchanger 14, through the second (inflow) thermal exchange lumen 26), wherein the heat exchange medium includes liquid phase matter (infusion of fluids (e.g., saline solution, therapeutic or diagnostic substances, radiographic contrast medium, etc.)); and
an extracorporeal temperature management system operatively coupled to the heat exchange catheter (extracorporeal heat exchanger 14 connected to catheter , Fig. 1), the extracorporeal temperature management system comprising:
a cooling device configured to cool the heat exchange medium to a predetermined temperature for flowing through the heat exchange via the inflow and outflow lumens of the heat exchange catheter ([0044]);
a first sensor configured to sense a body temperature of the subject and configured to be disposed in or on the subject ([0040] [0044] body temperature measuring apparatus 17; (e.g., a catheter or wire having a temperature sensor that is advanceable out of the distal tip of the catheter 12 or shaft 21 and useable for sensing the temperature of the subject's flowing blood);
a controller configured to:
receive one or more signals from the first sensor indicating the body temperature of the subject ([0040]).
Brian does not teach a chemical substance that alters a phase of the heat exchange medium; and
the cooling device configured to form solid phase matter thereby creating a heat exchange slurry for flowing through the heat exchanger via the inflow and outflow lumens of the heat exchange catheter;
controller to determine a required amount of the solid phase matter in the heat exchange slurry based on the body temperature of the subject and the target temperature and control an amount of the chemical substance in the heat exchange medium such that the heat exchange slurry contains the required amount of the solid phase matter.
However, Rozenberg teaches a device within the same field of invention (cooler 724) creating a heat exchange slurry (An ice slurry/two phase slurry comprising between 5-80% ice crystals is infused through a lumen [0011]. Cooler 724 and pump 722 infuse and/or recirculate the ice slurry, super-cooled gel or slush through lumens 716 and 721 and the chamber of flexible balloon 254 [0184]) and whereby the slurry can comprise a phase change liquid and a chemical substance (water and sodium chloride [0180] or water and a carrier liquid such as perfluorocarbon [0181].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was to modify the heat exchange medium such that it is a heat exchange slurry since Rozenberg teaches the small size of the ice particles provides a greater heat transfer area further improving the cooling efficiency [0227]. Furthermore, Brian is also concerned with inducing therapeutic hypothermia faster than heat exchange systems of the prior art [0008]. Furthermore, it would have been obvious to provide for a chemical substance in addition to the liquid phase matter since Rozenberg teaches this ensures that a portion of the liquid will remain a liquid as it is cooled to the freezing point [0179] and improves the fluidity of ice particles [0180].
Rozenberg generally provides for controlling slurry amount based on the body temperature of the subject and target temperature (The flow rate of the gas and liquid can be altered during the process according to the amount of cooling achieved. Feedback can be provided in the form of nose temperature, body temperature, brain temperature, rectal temperature, etc. For example, an alarm could be triggered when the body temperature falls below 35.degree. C. and delivery of the fluids and gas could be stopped [0113]), but it is silent about specifically teaching determining a required amount of the solid phase based on a target temperature.
However, Kasza ‘313 teaches a device within the same field of invention (medical ice slurry production device) whereby [0022][0015] A target temperature may be established corresponding to a desired loading concentration. The slurry production process may be considered "finished" when the slurry temperature drops to the target value, indicating that the desired loading concentration has been reached.
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the controller to determine a required amount of solid phase based on the body temperature and target temperature for the purpose of providing for the desired cooling.
With respect to controlling an amount of the chemical substance, Rozenberg provides ice concentration to be a result effective variable [0180] and provides the amount of chemical substance (e.g. freezing depressant) can be added to the liquid to ensure that portion of the liquid will remain a liquid as it is cooled to the freezing point [0179]. Rozenberg provides that the saline ice slurry can have various amounts of ice crystals and teaches depending on the ice concentration in the slurry, the ice slurry can have 5-7 times the cooling capacity of an equal volume of cooled liquid [0222].
Therefore, it would be obvious or one of ordinary skill in the art to have modified the controller such that it is capable of controlling an amount of the chemical substance to achieve a desired slurry concentration and ensure that portion of the liquid will remain a liquid as it is cooled to the freezing point [0179]
Regarding claim 59, Brian in view of Rozenberg and Kasza teaches the limitations of claim 58 as previously rejected above. The combination provides wherein the controller is configured to control a rate of flow of the heat exchange slurry circulating through the heat exchange catheter based on the body temperature of the subject and the target temperature to effect the target temperature of the subject (Rozenberg [0113] discusses controlling flow rate of the slurry based on body temperature).
Regarding claim 60, Brian in view of Rozenberg and Kasza teaches the limitations of claim 58 as previously rejected above. Rozenberg teaches wherein the chemical substance is a lubricious composition (sodium chloride or perfluorocarbon improves fluidity of ice particles [0180]).
Regarding claim 63, Brian in view of Rozenberg and Kasza teaches the limitations of claim 58 as previously rejected above. Kasza teaches wherein the controller is configured to control a rate of solid phase matter formation ([0020]).
Regarding claim 64 Brian in view of Rozenberg and Kasza teaches the limitations of claim 58 as previously rejected above. Brian does not teach a second sensor for sensing an amount of the solid phase matter in the heat exchange slurry.
Kasza teaches a sensor for sensing an amount of the solid phase matter in the heat exchange slurry, the controller configured to determine the required amount of the solid phase matter based on the amount of the solid phase matter in the heat exchange slurry ([0022] a thermocouple 52 may be provided within the slurry production reservoir 12 to monitor the temperature of the solution. [0015][0022] The temperature of the solution may be used as an indication of the amount of ice that has formed in the reservoir, providing an accurate estimate of the ice loading concentration of the slurry…. The slurry production process may be considered "finished" when the slurry temperature drops to the target value, indicating that the desired loading concentration has been reached).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include a sensor configured to sense an amount of the solid phase matter in order to adjust an amount of solid phase matter added to the heat exchange medium for the purposes of arriving at a desired loading concentration.
Regarding claim 67 Brian in view of Rozenberg, and Kasza teaches the limitations of claim 58 as previously rejected above. Kasza teaches wherein the controller is configured to control freezing of the liquid phase matter ([0015] Temperature controls 30 on the refrigeration unit 28 allow a technician to select the temperature of the coolant supplied to the copper cooling tank 18. Preferably a cooling temperature of about -27.degree. C. or other cooling temperature below the freezing point of the saline solution 36 is maintained).
Regarding claim 69, Brian teaches a system for cooling a subject to a target temperature (heat exchange catheter system 10) comprising:
a heat exchange catheter including an inflow lumen (12, Fig. 1, inflow tube 43), a heat exchanger configured to exchange heat with blood flowing through a blood vessel (intracorporeal heat exchanger 28), and an outflow lumen (outflow tube 45), the heat exchange catheter configured to receive a heat exchange medium through the inflow lumen, the heat exchanger, and the outflow lumen in a closed loop ([0044] Thermal exchange fluid is thus pumped from the inner tube 32 of the extracorporeal heat exchanger 14, through the second (inflow) thermal exchange lumen 26), wherein the heat exchange medium includes liquid phase matter (infusion of fluids (e.g., saline solution, therapeutic or diagnostic substances, radiographic contrast medium, etc.)); and
an extracorporeal temperature management system operatively coupled to the heat exchange catheter (extracorporeal heat exchanger 14 connected to catheter , Fig. 1), the extracorporeal temperature management system comprising:
a first sensor configured to sense a body temperature of the subject and configured to be disposed in or on the subject ([0040] [0044] body temperature measuring apparatus 17; (e.g., a catheter or wire having a temperature sensor that is advanceable out of the distal tip of the catheter 12 or shaft 21 and useable for sensing the temperature of the subject's flowing blood);
a controller configured to:
receive one or more signals from the first sensor indicating the body temperature of the subject ([0040]).
Brian does not teach a solid phase matter in the heat exchange medium and the controller to create a heat exchange slurry based on the body temperature of the subject and the target temperature.
However, Rozenberg teaches a device within the same field of invention (cooler 724) creating a solid phase matter in the heat exchange medium (An ice slurry/two phase slurry comprising between 5-80% ice crystals is infused through a lumen [0011]. Cooler 724 and pump 722 infuse and/or recirculate the ice slurry, super-cooled gel or slush through lumens 716 and 721 and the chamber of flexible balloon 254 [0184]) and controlling slurry amount based on the body temperature of the subject and target temperature (The flow rate of the gas and liquid can be altered during the process according to the amount of cooling achieved. Feedback can be provided in the form of nose temperature, body temperature, brain temperature, rectal temperature, etc. For example, an alarm could be triggered when the body temperature falls below 35.degree. C. and delivery of the fluids and gas could be stopped [0113]), but it is silent about specifically teaching determining a required amount of the solid phase based on a target temperature.
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide for solid phase matter in the heat exchange medium and control the heat exchange slurry based on body temperature since Rozenberg teaches the small size of the ice particles provides a greater heat transfer area further improving the cooling efficiency [0227].
The combination does not teach a second sensor configured to sense an amount of solid phase matter in the heat exchange medium; and determine a required amount of solid phase matter for the heat exchange medium; receive one or more signals from the second sensor indicating the amount of solid phase matter in the heat exchange slurry; and control the amount of the solid phase matter in the heat exchange slurry based on the required amount of the solid phase matter and the one or more signals from the second sensor.
However, Kasza teaches a device within the same field of invention (medical ice slurry production device) comprising at least one sensor configured to sense an amount of the solid phase matter ([0022] a thermocouple 52 may be provided within the slurry production reservoir 12 to monitor the temperature of the solution. [0015][0022] The temperature of the solution may be used as an indication of the amount of ice that has formed in the reservoir, providing an accurate estimate of the ice loading concentration of the slurry) and a controller (Fig. 1 temperature control 30) that receives sensor signals from said sensor , the controller to determine a required amount of solid phase matter based on a target temperature, receive one or more signals from the second sensor indicating amount of solid phase matter in the heat exchange slurry, and control the amount of solid phase matter (0022] a thermocouple 52 may be provided within the slurry production reservoir 12 to monitor the temperature of the solution. [0015][0022] The temperature of the solution may be used as an indication of the amount of ice that has formed in the reservoir, providing an accurate estimate of the ice loading concentration of the slurry [0022][0015] A target temperature may be established corresponding to a desired loading concentration. The slurry production process may be considered "finished" when the slurry temperature drops to the target value, indicating that the desired loading concentration has been reached ).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include a sensor configured to sense an amount of the solid phase matter that remains and have modified the controller such that it receives sensor signals and is configured to cause the controller to adjust an amount of solid phase matter added to the heat exchange medium for the purposes of arriving at a desired loading concentration and cooling.
Regarding claim 70, Brian in view of Rozenberg and Kasza teaches the limitations of claim 69 as previously rejected above. Rozenberg teaches wherein the heat exchange slurry upstream of the heat exchanger of the heat exchange catheter has a first amount of the solid phase matter and the heat exchange slurry downstream of the heat exchanger of the heat exchange catheter has a second amount of the solid phase matter less than the first amount (The cooler 724 of the apparatus for creating or adding particles of solid phase matter Fig. 29 in Rozenberg is a freezer device since it teaches melted slurry can be pumped back into cooler for further cooling to recreate the two-phase ice slurry, and then pumped back into chamber 703 through lumens [0185]).
Regarding claim 71, Brian in view of Rozenberg and Kasza teaches the limitations of claim 69 as previously rejected above. Brian teaches wherein the first sensor is configured to sense a body temperature of the subject downstream of the heat exchanger of the heat exchange catheter (temperature measuring apparatus 17; useable for sensing the temperature of the subject's flowing blood).
Regarding claim 72, Brian in view of Rozenberg and Kasza teaches the limitations of claim 69 as previously rejected above. Kasza teaches wherein the controller controls a rate of formation of the solid phase matter (see claim rejection 64).
Regarding claim 74, Brian in view of Rozenberg and Kasza teaches the limitations of claim 69 as previously rejected above. Brian teaches further comprising a cooling or warming device configured to cool or warm the heat exchange slurry downstream of the heat exchanger of the heat exchange catheter (cooler 14 cooler and heaters 16 18 can cool or warm the blood, Fig. 1 ).
Regarding claim 75, Brian in view of Rozenberg and Kasza teaches the limitations of claim 69 as previously rejected above. Rozenberg teaches wherein the heat exchange slurry has concentration of solid phase matter from about 18% by weight to about 50% by weight ([0180] the saline ice slurry can have a concentration of between 5-80% ice crystals, alternatively greater than 20% ice crystals, alternatively greater than 30% ice crystals, alternatively greater than 40% ice crystals).
Regarding claim 76, Brian in view of Rozenberg and Kasza teaches the limitations of claim 69 as previously rejected above. Rozenberg teaches wherein the controller is configured to control flow of the heat exchange slurry through the heat exchange catheter to effect the target temperature of the subject ( [0113] controlling flow rate of the slurry based on body temperature).
Regarding claim 77, Brian in view of Rozenberg and Kasza teaches the limitations of claim 69 as previously rejected above. While Kasza teaches the second sensor it is silent about specifically teaching wherein the second is disposed downstream of the heat exchanger of the heat exchange catheter. However, it would have been obvious to one of ordinary skill in the art at the time of the invention to rearrange the second sensor such that it is located downstream of the heat exchanger of the heat exchange catheter for the purposes of detecting the amount of ice that remains after the slurry is circulated through the heat exchanger and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (MPEP 2144.04 (VI-C)).
Claims 61-62 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brian (Pub. No. 2007/0043409) in view of Rozenberg (Pub. No. 2009/0234325), Kasza (Pub. No. 2007/0056313), and in further view of Roberts (4,958, 635).
Regarding claim 61, Brian in view of Rozenberg and Kasza teaches the limitations of claim 60 as previously rejected above. While Rozenberg teaches a freezing point depressant, such as sodium chloride, various alcohols, sugar or any other biologically Suitable freezing point depressant can be added to the liquid to ensure that a portion of the liquid will remain a liquid as it is cooled to the freezing point [0179], it does not teach glycol.
However, Roberts teaches a device within the same field of invention (thermal therapy) comprising glycol (Liquid medium 30 contained within layer 12 suitably comprises about 80 parts of water to 25 parts of propylene glycol, and forms a thick slush of ice crystals at 0.degree. F. which readily yields under hand pressure to become pliable; Col 3 lines 5-10).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provide for glycol for the chemical substance since it is a well-known freezing point depressant that would prevent the liquid from freezing when the temperature is below freezing temperature.
Regarding claim 62, Brian in view of Rozenberg, Kasza, and Roberts teaches the limitations of claim 60 as previously rejected above. Roberts teaches wherein the lubricious composition is a propylene glycol (Col 3 lines 5-10).
Claims 65 and 73 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brian (Pub. No. 2007/0043409) in view of Rozenberg (Pub. No. 2009/0234325), Kasza (Pub. No. 2007/0056313), and in further view of Kasza (Pub. No 2009/0255276).
Regarding claim 65, Brian in view of Rozenberg, and Kasza ‘313 teaches the limitations of claim 58 as previously rejected above. Brian does not teach an air separator to remove air from the heat exchange slurry.
However, Kasza’276 teaches a device within the same field of invention (medical ice slurry generator) comprising air separator ([0131]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to include an air separator in the combination since Kasza ‘276 provides it reduces air entrainment and more uniform mixing.
Claim 73 teaches the same limitations of claim 65 as previously rejected above.
Claim 66 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brian (Pub. No. 2007/0043409) in view of Rozenberg (Pub. No. 2009/0234325), Kasza (Pub. No. 2007/0056313), and in further view of Makino (Pub. No. 2005/0107006).
Regarding claim 66, Brian in view of Rozenberg and Kasza teaches the limitations of claim 58 as previously rejected above. Brian does not teach further comprising a third sensor configured to sense consistency of the heat exchange slurry, the controller configured to determine the required amount of the solid phase matter based on the consistency of the heat exchange slurry.
However, Makino teaches a similar device (an icemaking device). Makino teaches the ice mixing tank includes an ice slurry concentration sensor to measure the concentrations of ice slurry inside the ice mixing tank at all times for maintaining a predetermined concentration [0015].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the device to include an ice slurry concentration sensor since Rozenberg provides cooling capacity depends on ice concentration [0222] and it would be advantageous to maintain an appropriate ice slurry concentration to achieve the desired cooling.
Claim 68 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Brian (Pub. No. 2007/0043409) in view of Rozenberg (Pub. No. 2009/0234325), Kasza (Pub. No. 2007/0056313), and in further view of Oh (Pub. No 2008/0193653).
Regarding claim 68, Brian in view of Rozenberg and Kasza teaches the limitations of claim 58 as previously rejected above. Brian does not teach wherein the heat exchange medium includes phase change material capsules.
However, Oh teaches it would be advantageous to prepare phase change material in microcapsules since the microcapsule has a compact structure such that it has high thermal conductivity leading to high thermoresponsivity [Abstract].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have included phase change material microcapsules in the heat exchange medium since Oh teaches it would provide for an increase in thermoresponsivity.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASAMIN EKRAMI whose telephone number is (571)272-9803. The examiner can normally be reached 9:00-5:00.
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/Y.E/ Examiner, Art Unit 3794
/KAITLYN E SMITH/ Primary Examiner, Art Unit 3794
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