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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description:
121, 123, 124 in Figure 1
113-1 and 113-2 in Figure 3
123, 124, and 200 in Figure 5
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains more than 150 words and uses phrase which can be implied (“The present disclosure relates to”, “provided herein”). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the limitation “a multifunctional epidural catheter being equipped with a sensor for detecting a pressure” in lines 1-2 and “a pressure sensor” in line 15 renders the claim indefinite. It is unclear if “a sensor for detecting a pressure” and “a pressure sensor” are the same structures, or if the catheter comprises two, separate pressure sensors. For examination purposes, “a sensor for detecting a pressure” and “a pressure sensor” have been interpreted to be the same pressure sensor structure.
Claims 2-6 are rejected for being dependent upon claim 1.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-6 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 1, the limitation “a catheter insertion part being connected to the main body and inserted in a patient's body, wherein the catheter has a combined balloon attached to one side of the catheter insertion part that is inflated when the catheter is inserted in the patient's body so as to expand an empty space within the patient's body” in lines 3-7 positive recites and claims a human organism (“a patient’s body”, “the patient’s body”, “an empty space within the patient’s body”). It is suggested to amend this limitation to “a catheter insertion part being connected to the main body and configured to be inserted in a patient's body, wherein the catheter has a combined balloon attached to one side of the catheter insertion part that is inflated when the catheter is inserted in the patient's body so as to expand an empty space within the patient's body”, or similar.
Claims 2-6 are rejected for being dependent upon claim 1.
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 1-3 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) being equipped with a sensor (sensor 155) for detecting a pressure applied to a combined balloon (“Pressure and volume inside the balloon 140 are measured using sensors 155, such as pressure sensor” [0093]), wherein the catheter comprises a main body (hub 111 and expanding system 150; Figure 2), and a catheter insertion part (cannula 110) being connected to the main body and 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 inflated when the catheter is inserted in the patient's body so as to expand an empty space within the patient's body (Figures 7A-C), the multifunctional epidural catheter comprising:
a syringe connection part (connector 164, see Figure 3D) for a balloon formed on one side of the main body to protrude outside (Figure 2) and having a syringe for the balloon (fluid container 152; “container 152 (e.g. a syringe)” [0090]) connected thereto so as to supply fluid into the 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) being formed inside the main body (Figure 2), having one end connected to the syringe connection part for a balloon (Figure 2), and transferring the fluid supplied from the syringe to be supplied to the 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) being formed inside the main body (Figure 2), contacting the fluid transfer part (Figure 2, contact via housing 157), and measuring a pressure of the fluid according to an expansion or contraction of the 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]) being formed on an external side of the main body (Figure 2), receiving a measurement value detected by the pressure sensor, and numerically displaying 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 generating 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]).
Regarding claim 2, Tsamir discloses the multifunctional epidural catheter of claim 1, wherein the fluid transfer unit extends from the syringe connection part for the balloon so as to contact the pressure sensor by turning upward or downward along a direction of the pressure sensor that is fixed to an upper part or lower part of the fluid transfer unit, and progresses towards the catheter insertion part (Figure 2; “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.” [0058], contact via the housing 157).
Regarding claim 3, Tsamir disclose the multifunctional epidural catheter of claim 2, 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. 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.” [0058], contact via the housing 157).
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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: McCullagh et al. (US 20070260234) discloses a catheter (RF ablation device 100 including cannula 102; Figure 1) comprising an electrode (electrodes 112) comprising a conductive coating layer being conductively coated by a diamond like carbon (DLC) (“a thermally and electrically conductive coating of Diamond-like Carbon (DLC) is applied principally to the surface of the device's electrodes 112 as well as to other components of the RF ablation device 100” [0018]) having a thickness less than 0.1 mm (“The standard thickness of these layers is situated between 0.002 and 0.004 mm” [0019]).
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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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783