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 amendment filed 08/04/2025 has been entered. Claims 4-11, 13-17 & 56 remain pending in the application. Claims 1-3, 18-52 & 55 are cancelled. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed 04/03/2025.
Response to Arguments
Applicant's arguments with respect to claims 4-11, 13-17 & 56 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The claim amendments changed the scope of the claimed invention. See new grounds for rejection below.
Claim Interpretation
The use “for” in the claim is seen as intended use and therefore is given limited patentable weight and the prior art used below would be capable of performing the “for” function based on structure.
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.
Claim 56 is 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 56 recites the limitation "the third seal" in line 27. There is insufficient antecedent basis for this limitation in the claim since there is no prior mention of a third seal. Appropriate correction is required.
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.
Claim 8 is rejected under 35 U.S.C 103 as being unpatentable over Khanna (US 20190083302) herein referred to as Khanna, in view of Dobak, III (US 20050076924) herein referred to as Dobak.
Regarding Claim 8, Khanna discloses a detachable cooling apparatus for use in a focal hypothermia- inducing fluidics system for use in a brain of a patient comprising (Figure 27B): a distal running catheter forming a distal lumen that provides liquid as an input (See annotated Figure 2 below); and a proximal running catheter forming a proximal lumen that receives the liquid as an output (See annotated Figure 2 below), wherein the proximal running catheter is fluidly coupled to the distal running catheter along a closed-circuit flow path (Figure 2, 5); wherein the distal running catheter and the proximal running catheter define a catheter body having a proximal end region (Figure 27b, 73), a distal end region (Figure 27b; wherein where drainage ports 70 are located is seen as the distal end) and a flexible intermediate region between the proximal end region and the distal end region (Figure 27B, 69; Paragraph [0093]; wherein 69 is flexible), wherein the flexible intermediate region is configured to navigate through two 90 degree turns without kinking (Figure 21; wherein the structure allows for the flexible intermediate region to navigate a 90 degree turn without kinking therefore it would be capable or navigating a second 90 degree turn such as the one in Figure 7 without kinking); a connector at the proximal end region (See annotated Figure 27B below), the connector being configured for attachment, detachment, and alignment of the distal running catheter and the proximal running catheter to line up to one or more catheters associated with a fluidics pump and thermal-regulating mechanism that is configured to deliver the liquid to the detachable cooling apparatus (Paragraph [0093] wherein the proximal portion connects to the coolant and flow regulator as well as the drain lumen to a fluid removal device therefore acting as a connector), the proximal end region being formed of a stiffer material compared to both the flexible intermediate region and the distal end region and being configured to engage the one or more catheters associated with the fluidics pump and thermal-regulating mechanism in a sealed manner (Paragraph [0093]; wherein proximal end region contains stylet 74 which provides stiffness for the drain lumen); a heat-exchanger region located in the distal end region (Figure 2, 2) and defined by the distal running catheter that extends linearly (See annotated Figure 2 below) adjacent to the proximal running catheter and cools surrounding tissue with the liquid (Paragraph [0075]; wherein heat exchange portion 2 facilitates heat exchange and Paragraph [0078] discloses wherein by circulating the liquid through the catheters distal ends allows for cooling of the surrounding area) However, Khanna does not explicitly disclose a heat-exchanger region defined the proximal running catheter which has a high conductivity coiled form that wraps around the linearly extending distal running catheter.
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Dobak discloses cooling apparatus (Figure 1) comprising a heat-exchanger region (Figure 5, 14) defined the proximal running catheter which has a high conductivity coiled form that wraps around the linearly extending distal running catheter (Figure 5; wherein proximal running catheter 20 is seen as a part of the heat transfer element therefore is seen as high conductive which is disclosed in paragraph [0107], is coiled around distal running catheter 22). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the proximal running catheter taught by Khanna to be coiled as taught by Dobak. The motivation being the helical shape presents a cylindrical obstacle, in cross-section, to the flow of blood. Such obstacles tend to create turbulence in the free stream of blood. In particular, the form of turbulence is the creation of von Karman vortices in the wake of the flow of blood, downstream of the cylindrical obstacles (Dobak, Paragraph [0109]).
Claim 9 is rejected under 35 U.S.C 103 as being unpatentable over Khanna in view of Tzeng et al. (US 6716236) herein referred to as Tzeng.
Regarding Claim 9, Khanna discloses a detachable cooling apparatus for use in a focal hypothermia- inducing fluidics system for use in a brain of a patient comprising (Figure 27B): a distal running catheter forming a distal lumen that provides liquid as an input (See annotated Figure 2 below); and a proximal running catheter forming a proximal lumen that receives the liquid as an output (See annotated Figure 2 below), wherein the proximal running catheter is fluidly coupled to the distal running catheter along a closed-circuit flow path (Figure 2, 5); wherein the distal running catheter and the proximal running catheter define a catheter body having a proximal end region (Figure 27b, 73), a distal end region (Figure 27b; wherein where drainage ports 70 are located is seen as the distal end) and a flexible intermediate region between the proximal end region and the distal end region (Figure 27B, 69; Paragraph [0093]; wherein 69 is flexible), wherein the flexible intermediate region is configured to navigate through two 90 degree turns without kinking (Figure 21; wherein the structure allows for the flexible intermediate region to navigate a 90 degree turn without kinking therefore it would be capable or navigating a second 90 degree turn such as the one in Figure 7 without kinking); a connector at the proximal end region (See annotated Figure 27B below), the connector being configured for attachment, detachment, and alignment of the distal running catheter and the proximal running catheter to line up to one or more catheters associated with a fluidics pump and thermal-regulating mechanism that is configured to deliver the liquid to the detachable cooling apparatus (Paragraph [0093] wherein the proximal portion connects to the coolant and flow regulator as well as the drain lumen to a fluid removal device therefore acting as a connector), the proximal end region being formed of a stiffer material compared to both the flexible intermediate region and the distal end region and being configured to engage the one or more catheters associated with the fluidics pump and thermal-regulating mechanism in a sealed manner (Paragraph [0093]; wherein proximal end region contains stylet 74 which provides stiffness for the drain lumen); a heat-exchanger region located in the distal end region comprising a high conductivity inflatable bag that receives the liquid from the distal running catheter as the input to a distal region of the inflatable bag (Figure 7, 18; Paragraph [0078]; wherein distal portion 18 acts as a balloon by expanding when fluid is received from the distal running catheter and is a part of the heat exchange region therefore is seen as highly conductive) and wherein the proximal lumen receives the liquid from the inflatable bag as the output at a proximal region of the inflatable bag that connects the distal running catheter to the proximal running catheter and cools surrounding tissue with the liquid (Figure 7; wherein 18 connects the distal running catheter to the proximal running catheter and the flow would go through proximal running catheter). However, Khanna does not explicitly disclose wherein the inflatable bag is separate and distinct from the distal running catheter and surrounds the distal running catheter with each of the distal running catheter and the proximal running catheter extending distal to a distal end of the inflatable bag, wherein the distal running catheter includes a fluid input for delivering the liquid into the inflatable bag and the proximal running catheter includes a fluid output for removing the liquid from the inflatable bag, wherein the fluid input is located closer to distal end of the inflatable bag than the fluid output.
Tzeng discloses a cooling apparatus (Figure 1) wherein the inflatable bag is separate and distinct from the distal running catheter and surrounds the distal running catheter with each of the distal running catheter and the proximal running catheter extending distal to a distal end of the inflatable bag (Figure 3, 271), wherein the distal running catheter includes a fluid input for delivering the liquid into the inflatable bag (Figure 3, 270) and the proximal running catheter includes a fluid output for removing the liquid from the inflatable bag (Figure 3, 260), wherein the fluid input is located closer to distal end of the inflatable bag than the fluid output (Figure 3, 260 & 270; wherein 280 is seen as the distal end). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the inflatable bag taught by Khanna to incorporate the teaching of Tzeng inflatable bag. The motivation being the use of an inflation lumen allows the inflation fluid flow to be controlled independently of the heat exchange fluid flow. (Tzeng, Column 9, lines 54-56).
Claims 10-11 are rejected under 35 U.S.C 103 as being unpatentable over Khanna and Tzeng in further view of Dabrowiak (US 20190151143) herein referred to as Dabrowiak.
Regarding Claim 10, Khanna in view of Tzeng discloses the detachable cooling apparatus of claim 9. However, Khanna in view of Tzeng does not explicitly disclose wherein the flexible intermediate region comprises a fluidics midsection that thermally insulates the liquid that is input into the distal running catheter until it reaches the heat-exchanger region, and wherein each of the proximal running catheter and the distal running catheter extends beyond a distal end of the inflatable bag.
Dabrowiak discloses a detachable cooling apparatus (Figure 5) wherein the flexible intermediate region comprises a fluidics midsection that thermally insulates the liquid that is input into the distal running catheter until it reaches the heat-exchanger region (Paragraph [0064]; wherein heat exchange tubes are made of polyurethane therefore is seen as thermally insulating the fluid before it reaches 17, which is seen as the heat exchange region), and wherein each of the proximal running catheter and the distal running catheter extends beyond a distal end of the inflatable bag (Figure 9; wherein distal end extend beyond 17). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat exchanger region taught by in view of Tzeng to include the heat exchanger regions taught by Dabrowiak. The motivation being a simple substitution of one known heat exchanger design, the heat exchanger taught by Khanna in view of Tzeng for another, the heat exchanger region taught by Dabrowiak to obtain predictable results of heat exchange to the surrounding tissue (MPEP 2143 (B)).
Regarding Claim 11, Khanna and Tzeng in further view of Dabrowiak discloses the detachable cooling apparatus of claim 10. Dabrowiak also discloses wherein the fluidics midsection includes a polyurethane section that thermally insulates the liquid (Paragraph [0064]; wherein heat exchange tubes are made of polyurethane therefore is seen as thermally insulating). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the heat exchanger taught by Khanna and Tzeng in view of Dabrowiak to be made out of polyurethane. The motivation being its advantageously to be formed of a noncompliant polymeric material (Dabrowiak, Paragraph [0064]).
Claim 56, 4-7 & 13-14 are rejected under 35 U.S.C 103 as being unpatentable over Khanna in view of Yang et al. (US 20170239447) herein referred to as Yang.
Regarding Claim 56, Khanna discloses a detachable cooling apparatus for use in a focal hypothermia- inducing fluidics system for use in a brain of a patient comprising (Figure 27B): a distal running catheter forming a distal lumen that provides liquid as an input (See annotated Figure 2 below); and a proximal running catheter forming a proximal lumen that receives the liquid as an output (See annotated Figure 2 below), wherein the proximal running catheter is fluidly coupled to the distal running catheter along a closed-circuit flow path (Figure 2, 5); wherein the distal running catheter and the proximal running catheter define a catheter body having a proximal end region (Figure 27b, 73), a distal end region (Figure 27b; wherein where drainage ports 70 are located is seen as the distal end) and a flexible intermediate region between the proximal end region and the distal end region (Figure 27B, 69; Paragraph [0093]; wherein 69 is flexible), wherein the flexible intermediate region is configured to navigate through two 90 degree turns without kinking (Figure 21; wherein the structure allows for the flexible intermediate region to navigate a 90 degree turn without kinking therefore it would be capable or navigating a second 90 degree turn such as the one in Figure 7 without kinking); a connector at the proximal end region (See annotated Figure 27B below), the connector being configured for attachment, detachment, and alignment of the distal running catheter and the proximal running catheter to line up to one or more catheters associated with a fluidics pump and thermal-regulating mechanism that is configured to deliver the liquid to the detachable cooling apparatus (Paragraph [0093] wherein the proximal portion connects to the coolant and flow regulator as well as the drain lumen to a fluid removal device therefore acting as a connector), the proximal end region being formed of a stiffer material compared to both the flexible intermediate region and the distal end region and being configured to engage the one or more catheters associated with the fluidics pump and thermal-regulating mechanism in a sealed manner (Paragraph [0093]; wherein proximal end region contains stylet 74 which provides stiffness for the drain lumen). However, Khanna does not explicitly disclose and a removable first seal that is removably coupled to the proximal end region and a second seal that is coupled to the proximal end region, the first seal including an inlet port that is in fluid communication with the distal lumen of the distal running catheter, the second seal including a side outflow port that is in fluid communication with an outflow port of the proximal running catheter to direct fluid from the proximal running catheter into the side outflow port; wherein the first seal includes a first rotatable knob, the second seal including a second rotatable knob and a third rotatable knob spaced from the second rotatable knob, the side outflow port being between the second and third knobs to allow isolation of the side outflow port by the second and third knobs; wherein each of the first seal, the second seal, and the third seal has a through hole to permit the proximal end region to pass through each of the first seal, the second seal and the third seal.
Yang discloses a detachable cooling apparatus (Figure 1) disclose a removable first seal that is removably coupled to the proximal end region and a second seal that is coupled to the proximal end region (Figure 27A, 2626 & Figure 27B, 2608), the first seal including an inlet port that is in fluid communication with the distal lumen of the distal running catheter (Figure 27B, 2608), the second seal including a side outflow port that is in fluid communication with an outflow port of the proximal running catheter to direct fluid from the proximal running catheter into the side outflow port (Figure 27A, 2626; wherein when the seal is closed fluid will go out side outflow port 2620) wherein the first seal includes a first rotatable knob (Figure 27B, 2604; Paragraph [0174]; wherein knob 2604 rotates), the second seal including a second rotatable knob (Figure 27A, 2628; Paragraph [0173]; wherein knob 2628 rotates) and a third rotatable knob spaced from the second rotatable knob (Figure 27A, 2630; Paragraph [0172]; wherein 2630 is a part of the rotating valve therefore is seen as rotatable), the side outflow port being between the second and third knobs to allow isolation of the side outflow port by the second and third knobs (Figure 27A, 2620) wherein each of the first seal (Figure 27A, 2626), the second seal (Figure 27B, 2608), and a third seal (Figure 27A, 2620; Paragraph [0172]; wherein 2630 is a part of the rotating valve 2620 which a valve can act as a seal) has a through hole to permit the proximal end region to pass through each of the first seal (See annotated Figure 27B below; wherein the through hole is sized to permit the proximal end region to pass through which can be seen since the end region lines up perfectly with the seal), the second seal (See annotated Figure 27A below) and the third seal (Figure 27A; 2620; wherein a valve will have a hole to permit the proximal end region to pass through when seal is open). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the detachable cooling apparatus taught by Khanna in view of Yang to include the rotatable knobs and seals as taught by Yang. The motivation being to rotatably control fluid communication (Yang, Paragraph [0172]-[0174]).
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Regarding claim 4, Khanna in view of Yang discloses the detachable cooling apparatus of claim 56. Khanna also discloses further comprising: a sensor array that is operable to determine at least one of a temperature of the liquid or surrounding tissue, a pressure of the liquid or surrounding tissue, a flow rate of the liquid or surrounding tissue, and biological properties of the liquid or surrounding tissue(Figure 2, 4; Paragraph [0075]; wherein one or more sensors is seen as a sensor array since multiple sensors make up a sensor array and sensors can provide temperature regarding the patient therefore the tissue temperature since 4 would be in contact with tissue as well as pressure of the surrounding tissue); and an external controller operable to modify the at least one of the temperature, the pressure, and the flow rate (Paragraph [0036]; coolant and flow regulator controls the temperature and flow rate of the coolant).
Regarding claim 5, Khanna in view of Yang discloses the detachable cooling apparatus of claim 4. Khanna also discloses wherein the sensor array is located at a distal end section of the distal running catheter (Figure 2, 4).
Regarding claim 6, Khanna in view of Yang discloses the detachable cooling apparatus of claim 56. Khanna also discloses further comprising: a heat-exchanger region located in the distal end region and comprising a high conductivity loop that cools surrounding tissue with the liquid, the loop directly flow from the distal running catheter to the proximal running catheter (Figure 1 & Figure 2, 2).
Regarding claim 7, Khanna in view of Yang discloses the detachable cooling apparatus of claim 6. Khanna also discloses wherein the distal running catheter and the proximal running catheter are parallel to one another and the high conductivity loop is configured to change a flow direction of the liquid by a 180-degree angle (See annotated figure 2; wherein the distal and proximal catheters are parallel and the flow would change by 180 degrees after going through portion 5)
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Regarding claim 13, Khanna in view of Yang discloses the detachable cooling apparatus of claim 56. Khanna further discloses comprising: a connection that attaches the proximal end region of the detachable cooling apparatus to a fluidics cooling and pump system an additional set of lumens and ports for receiving at least one of a drug, a lavage, ventricular drain, or sensor wires (Paragraph [0078]; wherein there is an addition lumen acting as ventricular drain); and wherein the additional set of lumens and portions includes at least one lumen that introduces the drug, lavage, drain or sensor through a distal port located anywhere between the connection and a distal-most end of the detachable cooling apparatus (Figure 8; 22).
Regarding Claim 14, Khanna in view of Yang discloses the detachable cooling apparatus of claim 13. Yang also discloses wherein the connection connector is one of a screw lock and a luer lock (Paragraph [0126]; wherein solenoid valve is connected to a luer connector on the catheter). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the connector taught by Khanna to be a luer lock as taught by Yang. The motivation being to releasably connect the catheter to a chamber or collection canister (Yang, Paragraph [0126]).
Claims 15 are rejected under 35 U.S.C 103 as being unpatentable over Khanna and Yang in further view of Dabrowiak.
Regarding Claim 15, Khanna in view of Yang discloses the detachable cooling apparatus of claim 1. However, Khanna in view of Yangdoes not explicitly disclose wherein a diameter of the detachable cooling apparatus is less than 4.7 mm.
Dabrowiak discloses a detachable cooling apparatus (Figure 5) wherein a diameter of the detachable cooling apparatus is less than 4.7 mm (Paragraph [0064]; wherein heat exchange tubes which are the widest part of the cooling apparatus have a diameter between 2mm and 19mm therefore the cooling apparatus has a diameter less than 4.7mm).Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the diameter of Khanna and Yang to be within the diameter range taught by Dabrowiak. The motivation being so it can fit within all or a part of the human body (Dabrowiak, Abstract).
Claim 16 is rejected under 35 U.S.C 103 as being unpatentable over Khanna and Yang in further view of Khanna (US 200201998579) herein referred to as Khanna2002.
Regarding Claim 16, Khanna in view of Yang discloses the detachable cooling apparatus of claim 2 comprising an external temperature sensor for measuring a temperature of the surrounding tissue (Figure 2, 4; Paragraph [0075]; wherein one or more sensors is seen as a sensor array since multiple sensors make up a sensor array and sensors can provide temperature regarding the patient therefore the tissue temperature since 4 would be in contact with tissue). However, Khanna in view of Yang does not explicitly disclose an internal temperature sensor within the heat-exchanger region for measuring a temperature of the liquid.
Khanna2002 discloses a cooling apparatus (Figure 1) including an internal temperature sensor within the heat-exchanger region for measuring a temperature of the liquid and an external temperature sensor for measuring a temperature of the surrounding tissue (Claim 1-2; wherein device can contain more than one temperature sensors and temperature sensors are adjacent to the distal end of the catheter which is seen as the heat exchange region in claim 1, so that it senses the temperature of the cerebrospinal fluid and/or the central nervous system). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the cooling apparatus taught by Khanna in view of Yang to include a second temperature sensor within the head exchange region for measuring the temperature of a liquid as taught by Khanna2002. The motivation being achieving a desired temperature of the central nervous system by controlling the amount of heat transferred between the heat exchanger and the cerebrospinal fluid through regulation of the heat exchange fluid temperature and flow rate (Khanna2002, Claim 2).
Claim 17 is rejected under 35 U.S.C 103 as being unpatentable over Khanna, Yang and Khanna2002 in further view of Callister et al. (US 20060122673) herein referred to as Callister.
Regarding Claim 17, Khanna and Yang in view of Khanna2002 disclose the detachable cooling apparatus of claim 16. However, Khanna and Yang in view of Khanna2002 does not explicitly disclose wherein the external temperature sensor is located along the flexible intermediate region and is located up to 3 cm from the internal temperature sensor.
Callister discloses a cooling apparatus (Figure 5) wherein the external temperature sensor is located along the flexible intermediate region and is located up to 3 cm from the distal tip (Paragraph [0183]; wherein temperature sensor is located at least 3cm from the distal tip). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the detachable cooling apparatus taught by Khanna and Yang in view of Khanna2002 to position the external temperature sensor 3 cm from the internal temperature sensor which was taught to be in the distal tip. The motivation being to filter out fluctuating temperatures (Callister, Paragraph [0184]).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794