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 .
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 1-7 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.
Claim 1 recites the limitation "an electrode layer" in lines 4-5 and then introduces another “an electrode layer” in line 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the claimed invention requires two separate and distinct electrode layers or if the intention is for line 8 to reference the electrode layer of lines 4-5.
It is additionally noted that the claim states, “an electrode layer including a second electrode” (line 8) whereas the first electrode of line 7 has no association to an electrode layer. Given the numbering provided in the specification and claims, it appears electrode layer 122 should comprise first electrode 122a and second electrode 122b (“electrode layer 122 may be composed of two electrodes extending parallel to each other on the base layer” [0031], [0038] of the published application), but the claims do not currently recite this.
Claim 3 recites the limitation “in the other region between the first electrode and the second electrode” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. The area of “the other region” has not yet been defined in the claims.
Claim 5 recites the limitation “a common line… and configured to apply a voltage to the first electrode”. This limitation is indefinite because the specification states, “The common line 127 may apply a voltage to current sensor units 128a to 128h.” ([0051] of the published application) and does not disclose the common line applying voltage to any electrode.
Claims 2-7 are rejected to for being dependent on and for failing to remedy the deficiencies of claim 1.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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(s) 1 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (KR 102296026 B1) in view of Willard et al. (US 9,925,001) and Sorajja et al. (US 2022/0151711).
Regarding claim 1, Jeong et al. discloses an electrode apparatus for nerve denervation or modulation in vivo, comprising: a main body 110 including a shaft (fig. 1); and an electrode unit 120 (fig. 7) formed to protrude from one end of the shaft, configured to denervate or modulate at least a part of nerves on a tube in a body, and including a base layer 121 and an electrode layer 122 disposed on the base layer (“the electrode unit 120 includes a base layer 121 and an electrode layer 122 disposed on the base layer 121”), wherein the electrode unit 120 includes: a first electrode 122 disposed along a longitudinal direction of one side of the base layer 121; an electrode layer including a second electrode 122 disposed along a longitudinal direction of the other side of the base layer 121 (fig. 7; “the electrode layer 122 may include two electrodes extending parallel to each other on the base layer 121).
Jeong et al. does not expressly disclose a plurality of temperature sensor units spaced apart from each other at a predetermined interval between the first electrode and the second electrode and configured to measure a temperature. Willard et al. teaches it is known in the art for a plurality of temperature sensors 426 to be positioned between two electrodes 410, 412 disposed along a longitudinal direction on a device (fig. 9), in order to measure the temperature of target tissue or the electrodes at a plurality of locations along the length of the device (col. 25, lines 6-16). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jeong et al. to include a plurality of temperature sensor units spaced apart from each other at a predetermined interval between the first electrode and the second electrode and configured to measure a temperature as taught by Willard et al. in order to provide monitoring of temperature at the target tissue and at the electrodes (col. 25, lines 6-16), the results of such a modification being reasonably predictable in the art.
Jeong et al. does not expressly disclose a current sensor unit formed in a region between the first electrode and the second electrode and configured to measure a current generated from the first electrode or the second electrode; and a controller configured to calculate the resistance based on the current measured by the current sensor unit and calculate a diameter of the tube in the body based on the calculated resistance. Sorajja et al. teaches it is known in the art to detect the resistance of an applied current between two or more locations on a device ([0031]) via current sensors ([0077]), this measured current then used by a controller 601 ([0085]) to calculate a resistance that is then used to calculate a diameter of a tube in the body ([0031], [0077-0078]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jeong et al. to include a current sensor unit configured to measure a current generated from the first electrode or the second electrode and a controller configured to calculate a resistance based on the current measured by the current sensor unit and calculate a diameter of the tube in the body based on the calculated resistance as taught by Sorajja et al. as it is a known technique in the art, and would be useful in determining the amount of stimulation appropriate for different diameters of tubes within the body, the results of such a modification being reasonably predictable. The design choice of forming the current sensor unit between the first electrode and the second electrode would have been obvious to one of ordinary skill in the art since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 3, the limitation of, “a reference current sensor unit formed in the other region (35 U.S.C. 112 rejection) between the first electrode and the second electrode and configured to measure currents generated from the first electrode and the second electrode in order to calculate a reference resistance” is regarded as an additional current sensor or a duplication of parts, as the claim currently has not provided any structural differences between the claimed reference current sensor unit and the current sensor unit of claim 1. The calculated reference resistance from the reference current sensor unit is simply another current sensor unit that measures current and is used in a manner where a reference resistance is calculated. It would have been obvious to one of ordinary skill in the art to modify Jeong et al. and include an additional current sensor unit, used to calculate a reference resistance, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (KR 102296026 B1) in view of Willard et al. (US 9,925,001) and Sorajja et al. (US 2022/0151711) and further in view of Page et al. (US 2023/0079507).
Regarding claim 2, Jeong et al. does not expressly disclose wherein the controller regulates a period of time of applying a voltage to the first electrode and the second electrode based on the calculated diameter of the tube in the body. Page et al. teaches adjusting stimulation waveform parameters based on diameters of nerve structures in the body ([0215]), the stimulation waveform parameters including a predefined duration of applying stimulation ([0034], [0074]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jeong et al. to have the controller regulate a period of time of applying voltage to the electrodes based on a calculated diameter of the tube in the body as taught by Page et al. in order to provide stimulation parameters suited for different determined diameters of tubes in the body, the results of such a modification being reasonably predictable.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (KR 102296026 B1) in view of Willard et al. (US 9,925,001) and Sorajja et al. (US 2022/0151711) and further in view of Koblish et al. (US 2019/0038349).
Regarding claim 6, Jeong et al. does not expressly disclose the controller determines a contact state between the base layer and the tube in the body based on a plurality of temperature values sensed by the temperature sensor units. Koblish et al. teaches it is known in the art to use a plurality of temperature values sensed by temperature sensor units to determine the percentage of surface area of a device in contact with tissue ([0282]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jeong et al. and use a plurality of temperature values sensed by the temperature sensor units to determine a contact state between the base layer and the tube in the body as taught by Koblish et al. as it is a known technique for determining contact between a device and tissue of a body, the results of such a modification being reasonably predictable.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jeong et al. (KR 102296026 B1) in view of Willard et al. (US 9,925,001) and Sorajja et al. (US 2022/0151711) and further in view of Watanabe et al. (US 5,056,929).
Regarding claim 7, Jeong et al. in view of Willard et al. disclose wherein each of the temperature sensor units is configured as a thermocouple (col. 24, lines 61-63) but does not expressly disclose the thermocouple includes a temperature chip in a cold junction. Watanabe et al. discloses it is known in the art for a thermocouple to include a temperature chip 14 in a cold junction 14b (fig. 1; col. 1, lines 24-39). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Jeong et al. to use a thermocouple that comprised a temperature chip in a cold junction as taught by Watanabe et al. as the temperature sensor units as it is a known structure in the art, the results of such a modification being reasonably predictable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ERICA S LEE whose telephone number is (571)270-1480. The examiner can normally be reached M-F 8-7pm, flex.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ERICA S LEE/Primary Examiner, Art Unit 3796
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