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 July 13, 2026 has been entered. Claims 1 and 3-6 remain pending in the application. Claim 2 has been cancelled. Applicant’s amendments to the drawings, specification and claims have overcome the objections and rejections under 35 USC 112 and 35 USC 101 previously set forth in the Non-Final Office Action mailed January 13, 2026, except for those noted below.
Claim Objections
Claim 1 is objected to because there is a lack of antecedent basis for “the bending structure of the fluid transfer part” in line 30. Appropriate correction is required.
Claim 6 is objected to because there is a lack of antecedent basis for “the RF electrode unit” in line 1-2 and “the RF electrode” in line 3 as opposed to “the RF electrode part”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tsamir et al. (US 20150342635).
Regarding claim 1, Tsamir discloses a multifunctional epidural catheter (device 100) comprising:
a main body (hub 111 and expanding system 150; Figure 2);
a catheter insertion part (cannula 110) configured to be connected to the main body and configured to be inserted in a patient's body, wherein the catheter has a combined balloon (balloon 140) attached to one side of the catheter insertion part (“Cannula 110 comprises an expandable element 140 attached laterally at a distal end 109 of cannula 110” [0052]; Figure 2) that is configured to be inflated to expand an empty space within the patient's body (Figures 7A-C);
a syringe connection part (connector 164, see Figure 3D) for the combined balloon formed on one side of the main body to protrude outside (Figure 2) and configured to be connected to a syringe (fluid container 152; “container 152 (e.g. a syringe)” [0090]) to supply a fluid into the combined balloon (“Pump 151 may be arranged to controllably pump fluid such as gas (e.g., air) or liquid (e.g., saline or water) into and out of balloon 140. Pump 151 is preferably a peristaltic pump that pumps fluid into and out of balloon 140, e.g., by squeezing pump tubing 161 in a sterile manner, without having the fluid being in contact with pump 151. Container 152 may be used to hold fluid and is connected to pump tubing 161.” [0056]);
a fluid transfer part (pump tubing 161 and fluid delivery lumen 122) formed inside the main body (Figure 2), having one end connected to the syringe connection part for the combined balloon (Figure 2), and configured to transfer the fluid supplied from the syringe to the combined balloon (“expandable element 140 may be a sensing balloon 140 or 140A, which is internally in fluid communication with a fluid-delivery lumen 122 and is expandable by introduction of a fluid through fluid-delivery lumen 122.” [0053]; “Pump tubing 161 connects to side port 160 to supply fluid or gas from expanding system 150 to balloon 140” [0078]);
a pressure sensor (sensor 155) formed inside the main body (Figure 2), configured to contact the fluid transfer part (Figure 2, “sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130” [0058]; contact via cannula 110/needle 130), and configured to measure a pressure of the fluid according to an expansion or contraction of the combined balloon (“Sensor 155 is arranged to measure physical parameters associated with balloon 140. In certain embodiments, sensor 155 may be placed inside housing 157 that contains pump 151 and micro-processor 153. In certain embodiments, sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130, or in the vicinity of them. Such sensors 155 may be pressure sensors…The data collected by sensor 155 is sensed while balloon 140 exerts pressure onto portions of the mammalian tissue. The sensed data is of physical parameters associated with expandable device 140, and reflects mechanical properties of the tissue in which balloon 140 is disposed while obtaining the sensed data.” [0058]);
a display unit (indication device 156; [0061]) formed on an external side of the main body (Figure 2), configured to receive a measurement value detected by the pressure sensor, and configured to numerically display the received value (“Micro-processor 153 receives data from sensor 155 and controls pump 151. Micro-processor 153 may record, store and analyze the data received from sensor 155 in real-time or near real-time…The output of micro-processor 153 may be indicated to the operator in real-time through an indication device 156.” [0060]; “pressure sensor 155 measures the rapid changes in pressure inside the sensing balloon 140. The measured data is stored in microcontroller 153 and analyzed to detect the frequency of the pulsation…The analyzed data may be shown to the user by visual or acoustic means in the indication device 156 (For example the frequency of the pulsation may be shown on a small LCD screen).” [0114]); and
an alarm unit configured to generate a visual or auditory alarm (“Alert user by acoustic and visual means: Visual and acoustic means indicate the physician that cannula 110 has migrated outside epidural Space 70.” [0117]) when the pressure measured by the pressure sensor reaches a threshold value (“Upon crossing ligamentum flavum 60 with needle tip 135 and entrance into epidural space 70, a sudden drop in pressure occurs in sensing balloon 140…anchoring balloon 140B is automatically and controllably expanded upon detection of epidural space 70, in order to engage with the surrounding tissue, e.g., ligamentum flavum 60, and to exert pressure onto it in a manner that locks cannula 110 and, consequently, needle 130 in place, and prevent inadvertent puncture of Dura mater 80. In addition, an alert such as an acoustic or visual indication is given to the physician.” [0093]),
wherein an entire portion of the fluid transfer part (proximal end portion of pump tubing 161 and/or fluid-delivery lumen 122, noted that the limitation “an entire portion of the fluid transfer part” is broader than “an entirety of the fluid transfer part”, for example) is formed inside the main body (wherein an entirety of the proximal end portion of tubing 161 is formed within expanding system 150 and an entirety of the fluid-delivery lumen 122 is formed within hub 111; Figures 2 and 3A),
wherein the pressure sensor (sensor 155) is located above the fluid transfer part (in arrangement where sensor 155 is mounted to a proximal end of the cannula 108, the sensor 155 is located at least above tubing 161: “sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130” [0058]),
wherein the fluid transfer part extends from the syringe connection part (“Pump tubing 161 connects to side port 160 to supply fluid or gas from expanding system 150 to balloon 140” [0078]), bends upward toward the pressure sensor (tubing 161 extends upward from the expanding system 150 toward the proximal end of cannula 110 which includes sensor 155: “sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130” [0058]; Figure 2), horizontally extends while being in contact with the pressure sensor, and progresses toward the catheter insertion part (“expandable element 140 may be a sensing balloon 140 or 140A, which is internally in fluid communication with a fluid-delivery lumen 122 and is expandable by introduction of a fluid through fluid-delivery lumen 122.” [0053]; Figure 2) so that the bending structure of the fluid transfer part reduces a speed of the fluid due to friction to act as a buffer and preemptively delivers an instantaneous excessive pressure from the syringe connection part to the pressure sensor before the fluid reaches the combined balloon (Figure 2 and “sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130” [0058], wherein velocity of the fluid would be reduced by the passage from expanding system 150 through tubing 161 and when the sensor 155 is mounted on a proximal end of cannula 110, any instantaneous excessive pressure from container 152 would reach the sensor 155 before reaching balloon 140).
Regarding claim 3, Tsamir disclose the multifunctional epidural catheter of claim 1, wherein a part of the fluid transfer unit contacting the pressure sensor is the fluid transfer unit contacting an entire length of a pressure sensor surface (Figure 2; “Sensor 155 is arranged to measure physical parameters associated with balloon 140…sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130” [0058], contact via cannula 110 or needle 130).
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 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Tsamir et al. (US 20150342635) in view of Kim et al. (US 20210030466) further in view of Organ et al. (US 20120089123) in further view of Benscoter et al. (US 20140052120).
Regarding claim 4, Tsamir discloses the multifunctional epidural catheter of claim 1.
Tsamir fails to explicitly disclose the catheter comprises: a radio frequency (RF) electrode part being formed on an end of the catheter insertion part, a wire being connected to the RF electrode part, a power supply part being connected to the wire so as to supply power to the wire, and a thermocouple being configured to measure a temperature detected by a pulsed radio frequency (RF) generated from the RF electrode part, wherein the thermocouple comprises a conductive coating layer being conductively coated by a diamond like carbon (DLC).
Kim teaches a multifunctional epidural catheter (Figure 1; “an epidural catheter with a radio frequency (RF) generation function” [0002]), the catheter comprises: a radio frequency (RF) electrode part (RF electrodes 130, 140) being formed on an end of the catheter insertion part (“RF electrodes (130, 140) are separately provided at an end of the catheter inserting part (100)” [0034]; Figure 4), a wire (steering wires 110, 120) being connected to the RF electrode part (Figure 4), a power supply part being connected to the wire so as to supply power to the wire (“the main body (102) is connected to an external power source, or equipped with an RF generator having it own internal power source, such as a battery, and so on, and the two steering wires (110, 120) are connected to each of a cathode end and an anode end of the RF generator.” [0035]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the multifunctional epidural catheter of Tsamir to include a radio frequency electrode part, a wire, and a power supply part based on the teachings of Kim to maximize spinal pain relief by combining RF treatment with medication injection using a single multifunctional epidural catheter (Kim [0006], [0015]).
Modified Tsamir in view of Kim fails to explicitly disclose a thermocouple being configured to measure a temperature detected by a pulsed radio frequency (RF) generated from the RF electrode part, wherein the thermocouple comprises a conductive coating layer being conductively coated by a diamond like carbon (DLC).
Organ discloses a multifunctional epidural catheter (multi-purpose catheter probe CP1) comprising a radio frequency electrode part (“the catheter distal end 4 acts as an electrode” [0058]) and a thermocouple being configured to measure a temperature detected by a pulsed radio frequency (RF) generated from the RF electrode part (“A fifth function of the multi-purpose catheter probe CP1 is a means for monitoring tissue temperature. A very small diameter tubular thermocouple probe, described in association with FIGS. 2 and 3, is positioned within the lumen of the tubular catheter body 3 and the catheter distal end 4. A thermocouple member, inside the thermocouple probe, is positioned at a predetermined location within the length of the catheter distal end 4 to measure a change in tissue temperature related to the application of, for example, pulsed RF stimulation or RF ablation energy. The thermocouple probe is connected to a temperature measuring instrument via two leads within the flexible multi-lead cable 8” [0059]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the multifunctional epidural catheter of Tsamir to include a thermocouple being configured to measure a temperature detected by a pulsed radio frequency (RF) generated from the RF electrode part based on the teachings of Organ to allow for monitoring of the temperature of the targeted epidural tissue during treatment (Organ [0032, [0059]])
Modified Tsamir fails to explicitly disclose the thermocouple comprises a conductive coating layer being conductively coated by a diamond like carbon (DLC).
Benscoter discloses a catheter (catheter 12) comprising an electrode (electrode 30) comprising a conductive coating layer being conductively coated by a diamond like carbon (DLC) (“FIGS. 10C-10H show close-up views of carrier arm 90 portions wherein the electrodes 30 are partially conductive…The remaining portions 100 of the electrodes 30 may be selectively conductive (for example, composed of gold with a thin film outer layer of tantalum that has been oxidized to form tantalum pentoxide) or electrically insulated but thermally conductive (for example, having an outer layer of diamond-like carbon)” [0058]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the thermocouple of the multifunctional epidural catheter of Tsamir in view of Organ to comprises a conductive coating layer being conductively coated by a diamond like carbon based on the teachings of Benscoter to dissipate heat while also preventing energy loss (Benscoter [0058]).
Regarding claim 5, modified Tsamir discloses the multifunctional epidural catheter of claim 4.
Modified Tsamir fails to explicitly disclose the conductive coating layer is within a range of 0.03 to 0.1 mm.
Benscoter discloses a catheter (catheter 12) comprising an electrode (electrode 30) comprising a conductive coating layer being conductively coated by a diamond like carbon (DLC) (“The remaining portions 100 of the electrodes 30 may be selectively conductive (for example, composed of gold with a thin film outer layer of tantalum that has been oxidized to form tantalum pentoxide) or electrically insulated but thermally conductive (for example, having an outer layer of diamond-like carbon)” [0058]) within a range of 0.03 to 0.1 mm (“this layer may be between approximately 10 nm and approximately 5000 nm.” [0058], “each of the electrodes 30 and portions of the carrier arm 90 between the electrodes 30 may be approximately 3 mm wide.” [0055]; Figures 10C-10H showing that the coated portions 100 of the electrodes are along the full length of each electrode 30, and therefore cover at least 0.1 mm).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the thermocouple of the multifunctional epidural catheter of Tsamir in view of Organ to comprises a conductive coating layer within a range of 0.03 to 0.1 mm based on the teachings of Benscoter to dissipate heat while also preventing energy loss (Benscoter [0058]).
Regarding claim 6, modified Tsamir discloses the multifunctional epidural catheter of claim 4.
Modified Tsamir fails to explicitly disclose the RF electrode unit is connected to an end of the catheter insertion part, and wherein the RF electrode is used for a direction change of the catheter insertion part along with the wire.
Kim teaches a multifunctional epidural catheter (Figure 1; “an epidural catheter with a radio frequency (RF) generation function” [0002]), the catheter comprises: an RF electrode unit (RF electrodes 130, 140) connected to an end of the catheter insertion part (“RF electrodes (130, 140) are separately provided at an end of the catheter inserting part (100)” [0034]; Figure 4), and wherein the RF electrode is used for a direction change of the catheter insertion part along with the wire (“the steering wires (130, 140) for moving the inserting part (100) of the epidural catheter from left-to-right (or right-to-left) inside the physical body have been mutually used for forming RF electrodes (130, 140).” [0045])
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the multifunctional epidural catheter of Tsamir to include the RF electrode unit is connected to an end of the catheter insertion part, and wherein the RF electrode is used for a direction change of the catheter insertion part along with the wire based on the teachings of Kim to maximize spinal pain relief by combining RF treatment with medication injection using a single multifunctional epidural catheter without necessitating increasing the diameter of the catheter insertion part which could lead to critical side effects (Kim [0006], [0015], [0044-0045]).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 4-6 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.
Regarding the argument that Tsamir does not disclose “an entire portion of the fluid transfer part is formed inside the main body” as required by amended claim 1 (Remarks, page 7-8), the examiner respectfully disagrees. Tsamir discloses a multifunctional epidural catheter (100) comprising: a main body (111, 150; Figure 2); and a fluid transfer part (161, 122), wherein an entire portion of the fluid transfer part (proximal end portion of pump tubing 161 and/or fluid-delivery lumen 122) is formed inside the main body (wherein an entirety of the proximal end portion of tubing 161 is formed within expanding system 150 and an entirety of the fluid-delivery lumen 122 is formed within hub 111; Figures 2 and 3A). It is noted that the limitation “an entire portion of the fluid transfer part” is broader than “an entirety of the fluid transfer part”, for example.
Regarding the argument that Tsamir does not disclose “wherein the pressure sensor is located above the fluid transfer part” as required by amended claim 1 (Remarks, page 7-8), the examiner respectfully disagrees. Tsamir discloses that the pressure sensor (155) is located above the fluid transfer part (in arrangement where sensor 155 is mounted to a proximal end of the cannula 108, the sensor 155 is located at least above tubing 161: “sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130” [0058]).
Regarding the argument that Tsamir “fails to teach that the pump tubing 161 shown in FIG. 2 of Tsamir bends upward toward the sensor 155 and horizontally extends while being in contact with the sensor 155” as required by amended claim 1 (Remarks, page 8), the examiner respectfully disagrees. Tsamir discloses the fluid transfer part (161, 122) extends from the syringe connection part (“Pump tubing 161 connects to side port 160 to supply fluid or gas from expanding system 150 to balloon 140” [0078]), bends upward toward the pressure sensor (tubing 161 extends upward from the expanding system 150 toward the proximal end of cannula 110 which includes sensor 155: “sensor 155 may be mounted on a proximal end 108 of cannula 110 or needle 130F” [0058]; Figure 2), horizontally extends while being in contact with the pressure sensor, and progresses toward the catheter insertion part (“expandable element 140 may be a sensing balloon 140 or 140A, which is internally in fluid communication with a fluid-delivery lumen 122 and is expandable by introduction of a fluid through fluid-delivery lumen 122.” [0053]; Figure 2).
Regarding the argument that “Benscoter fails to teach the DLC coating layer claimed in claims 4-5” (Remarks, page 9), the examiner respectfully disagrees. As detailed in the rejection of claims 4-5 above, Benscoter discloses a catheter (12) comprising an electrode (30) comprising a conductive coating layer being conductively coated by a diamond like carbon (“The remaining portions 100 of the electrodes 30 may be…electrically insulated but thermally conductive (for example, having an outer layer of diamond-like carbon)” [0058]) within a range of 0.03 to 0.1 mm (“each of the electrodes 30 and portions of the carrier arm 90 between the electrodes 30 may be approximately 3 mm wide.” [0055]; Figures 10C-10H showing that the coated portions 100 of the electrodes are along the full length of each electrode 30, and therefore cover at least 0.1 mm). Applicant presents the argument that “claim 4 recites a conductive coating layer…which provides an insulating function”; however the claims are currently presented do not require “an insulation function”. However, Benscoter does disclose a DLC coating providing at least electrical insulation (Benscoter [0058]). Therefore, it is maintained that it would have been obvious to one having ordinary skill in the art to further modify the thermocouple of the multifunctional epidural catheter of Tsamir in view of Organ to comprises a conductive coating layer within a range of 0.03 to 0.1 mm based on the teachings of Benscoter to dissipate heat while also preventing energy loss (Benscoter [0058]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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