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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/31/2025 has been entered.
Response to Amendment
The Amendments filed December 31, 2025 have been entered. Currently, claims 1, 4, 11-12 have been amended, claim 3 has been cancelled, and claims 1-2, 4, 7-12 are pending in the application.
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 1-2, 7-12 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 following limitations: “the tip” in line 17, “the electrical impedance” in line 21, “the type of biological tissue” in line 24, "the temporal change" in line 25, and “the measured value” in lines 4-5 of page 3. There is insufficient antecedent basis for these limitations in the claim. Claims 2, 7-10 are also rejected because they are dependent on claim 1. Appropriate correction is required.
Claim 1 recites the limitation "the amount of change in the electrical impedance" in line 2 of page 3. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this amount of change is different from the temporal change in the repeatedly measured electrical impedance cited previously in line 25 of the claim, or if they are the same change in impedance. For examination purposes, Examiner will treat both changes as being the same. Claims 2, 7-10 are also rejected because they are dependent on claim 1. Appropriate correction is required.
Claim 11 recites the following limitations: “the electrical impedance” in line 3, “the type of biological tissue” in line 6, "the temporal change" in line 6, “the tip” in line 22, and “the measured value” in lines 3-4 of page 5. There is insufficient antecedent basis for these limitations in the claim. Appropriate correction is required.
Claim 11 recites the limitation "the amount of change in the electrical impedance" in line 2 of page 5. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this amount of change is different from the temporal change in the repeatedly measured electrical impedance cited previously in lines 6-7 of the claim, or if they are the same change in impedance. For examination purposes, Examiner will treat both changes as being the same. Appropriate correction is required.
Claim 12 recites the following limitations: “the electrical impedance” in line 4, “the type of biological tissue” in line 7, "the temporal change" in line 7, “the tip” in line 2 of page 6, and “the measured value” in lines 6-7 of page 6. There is insufficient antecedent basis for these limitations in the claim. Appropriate correction is required.
Claim 12 recites the limitation "the amount of change in the electrical impedance" in line 5 of page 6. The recitation renders the scope of the claim as indefinite because it is unclear to Examiner whether this amount of change is different from the temporal change in the repeatedly measured electrical impedance cited previously in lines 7-8 of the claim, or if they are the same change in impedance. For examination purposes, Examiner will treat both changes as being the same. 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.
Claims 1-2, 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey (W.O. Application No. 2001087154 A1), in view of Wong (U.S. Application No. 20020068931 A1), in view of Schmulewitz (E.P. Application No. 1440665 B1), and further in view of Paassilta (U.S. Application No. 20100286507 A1).
Regarding independent claims 1 and 11, as best understood, Hoey discloses a paracentesis assistance system (10) (page 9, lines 6-8 & Fig. 1), comprising:
an electrode needle (22) configured to be inserted into a biological tissue (page 4, lines 1-2; page 9, lines 16-19), the electrode needle comprising:
a measurement device (20) (page 9, lines 8-9) configured to apply high-frequency waves to at least two electrodes of the electrode needle when the electrode needle is inserted into a biological tissue (page 10, lines 16-20), and repeatedly measure the electrical impedance of the biological tissue where the electrodes are located (page 11, lines 4-9); and
an identification device (i.e., CPU 14) configured to identify the type of biological tissue based on the temporal change in the repeatedly measured electrical impedance (page 5, lines 2-4; page 11, lines 4-18); and
wherein the identification device is configured to calculate the amount of change in the electrical impedance within a predetermined period of time (page 3, lines 14-16); and
the identification device is configured to identify that the type of biological tissue changes when the calculated amount of change is within a predetermined value range (page 13, lines 8-11).
However, Hoey does not teach calculating the amount of change in the electrical impedance within a predetermined period of time based on ׀EI2-EI1/ EI1 or ׀EI2-EI1׀/EI2, wherein EI1 is the measured value of the electrical impedance of a first tissue, and EI2 is the measured value of the electrical impedance of a second tissue, when the type of biological tissue located at the tip of the electrode needle changes from the first tissue to the second tissue.
Wong, in the same field of endeavor, teaches a method and apparatus for monitoring and controlling the treatment of tissue by providing real time measurements of the impedance of tissue (pa. 0012). Moreover, Wong teaches calculating the amount of change in the electrical impedance within a predetermined period of time based on
(
Z
i
-
Z
f
)
Z
i
where
Z
i
is the initial impedance and
Z
f
is the final impedance (pa. 0072).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the function of the identification device of Hoey to allow for such calculations described by Wong for the purpose of gathering more accurate feedback necessary to control the application of ablation therapy to the tissue.
However, Hoey/Wong combination do not teach the electrode needle comprising a cylindrical internal electrode needle, a cylindrical external electrode needle covering an outer surface of the internal electrode needle, a first insulation layer located between the internal electrode needle and the external electrode needle, and a second insulation layer covering an outer surface of the external electrode needle, wherein the internal electrode needle comprises a pointed end part that is exposed from the external electrode needle, the external electrode needle comprises an end face that is exposed from the first insulation layer and the second insulation layer, and the pointed end part of the internal electrode needle and the end face of the external electrode needle are arranged in a longitudinal direction at the tip of the electrode needle and function as at least two electrodes.
Schmulewitz, in the same field of endeavor, teaches an electrode needle (21) comprising two or more electrodes disposed on a needle, and operable in a bipolar mode for cauterizing specified volumes of tissue when activated (pa. 0038 & Fig. 1), wherein a distal region (2) of the electrode needle comprises:
a cylindrical internal electrode needle (29);
a cylindrical external electrode needle (28) covering an outer surface of the internal electrode needle (pa. 0042 & Figs. 3-4);
a first insulation layer (42) located between the internal electrode needle and the external electrode needle (pa. 0042); and
a second insulation layer (44) covering an outer surface of the external electrode needle (pa. 0043);
wherein:
the internal electrode needle comprises a pointed end (41) part that is exposed from the external electrode needle (pa. 0045);
the external electrode needle comprises an end face (measured by length LPE as seen in Fig. 3) that is exposed from the first insulation layer and the second insulation layer (pa. 0043), and
the pointed end part of the internal electrode needle and the end face of the external electrode needle are arranged in a longitudinal direction at the tip of the electrode needle and function as at least two electrodes (pa. 0042).
Furthermore, the electrode needle includes a handle comprising a control device (22) with a control circuit (39) (pa. 0048 & Fig. 2A). During the application of energy to the tissue, current flows between the two electrodes on the electrode needle in accordance with Ohm's law (i.e., as the product of (current)2 x (tissue impedance)) (pa. 0061). The impedance is continuously monitored since impedance of tissue increases when it is cauterized, leading to a decrease in the sensed current detected by the control circuit (pa. 0063), helping indicate to a clinician when a treatment is complete. Examiner highlights that while the electrode needle of Schmulewitz is mainly purposed for cauterizing tissue, the electrodes disposed on the device can be in electrical communication with the circuitry that continuously monitors tissue impedance, albeit for purposes only relating to the application of treatment energy to the tissue instead of for identifying tissue type. Nevertheless, the electrodes in the electrode needle of Schmulewitz are still capable of being inserted into living tissue and being connected to a measuring circuitry (such as for example, the measurement device of Hoey) for monitoring/detecting the tissue impedance between the electrodes in order to help the operator identify tissue types.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle electrode of Hoey with the needle electrode of Schmulewitz since they are both known equivalents in the art and they would both yield the predictable results of being inserted into living tissue and allowing for the measurement of tissue impedance between two adjacent electrodes on the distal tip of the needle electrode device.
However, Hoey/Wong/Schmulewitz combination do not teach a notification unit configured to give notification depending on an identification result by the identification device.
Paassilta, in the same field of endeavor, teaches a system (1) for determining the position of a needle in an organ, comprising a needle (2) with a distal tip (3), a measurement circuit (4) for measuring the bioimpedance of tissues, a detection means (10) connected to the measurement circuit for measuring bioimpedance and arranged to detect the progress of the distal tip (3) of the needle at a real-time basis from the bioimpedance measured from tissues (abstract & Fig. 1). The system further includes a notification unit/signaling device (12) which produces a visible and/or audible signal when the distal tip of the needle reaches a tissue of a specific type (pa. 0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the notification unit of Paassilta to be in electrical communication with the identification device of Hoey for the purpose of providing a visual/auditory signal to the user to further confirm the location of the needle electrode.
Regarding claim 2, Hoey/Wong/Schmulewitz/Paassilta combination discloses wherein the identification device is configured to calculate a time average of the electrical impedance within a predetermined period of time (Hoey, page 6, lines 19-25), and compare the calculated time average with a database that associates the type of biological tissue with a reference value of the time average, thereby identifying the type of biological tissue (Hoey, page 12, lines 21-25 – page 13, lines 1-4).
Regarding claim 7, Hoey/Wong/Schmulewitz/Paassilta combination discloses wherein the identification device is configured to identify whether the electrodes are located in a nerve tissue (Hoey, page 4, lines 24-25 – page 5, lines 1).
Regarding claim 8, Hoey/Wong/Schmulewitz/Paassilta combination wherein the identification device is configured to identify whether the electrodes are located in a biological tissue between muscles (Hoey, page 16, line 25 – Page 17, lines 1-4). Specifically, the system of Hoey is capable of using impedance measurements to determine whether the distal tip of the electrode needle is adjacent to nerve tissue or prostate gland tissue, wherein the prostate gland tissue consists of smooth muscle tissue.
Regarding claim 9, Hoey/Wong/Schmulewitz/Paassilta combination discloses further comprising an electrical stimulus generator configured to apply an electrical pulse to the electrodes to stimulate the biological tissue (Hoey, page 13, line 25 – Page 14, lines 1-2 & Fig. 2). Examiner notes that an electrical stimulus generator must be present in the system of Hoey since ablating energy is provided to the electrodes of the electrode needle.
Regarding claim 10, Hoey/Wong combination discloses the invention substantially as claimed in claims 1 and 7 discussed above.
Schmulewitz teaches a method wherein the electrode needle is used in tandem with a local anesthetic (pa. 0034).
However, they do not teach wherein the electrode needle is hollow, and is configured to inject an anesthetic through the electrode needle into the biological tissue where the electrodes are located.
Paassilta, in the same field of endeavor, teaches a first embodiment where the needle (50) is hollow (pa. 0030) and configured to inject an anesthetic through the needle into the biological tissue where the electrodes are located (pa. 0046), or a second embodiment where the needle is not hollow (pa. 0031).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the internal electrode needle to be a hollow structure that is fluid communication with an analgesic, as taught by Paassilta, for the purpose of aiding in patient’s physical comfort.
Regarding independent claim 12, as best understood, Hoey discloses a non-transitory computer-readable medium storing a program (e.g., ROMs) (page 17, lines 17-22) that when executed by a processor (20) (page 9, lines 8-9), causes a computer (page 6, lines 13-16) to perform a method comprising:
applying high-frequency waves to at least two electrodes of an electrode needle (22) when the electrode needle is inserted into a biological tissue (page 4, lines 1-2; page 9, lines 16-19), and repeatedly measure the electrical impedance of the biological tissue where the electrodes are located (page 11, lines 4-9); and
identifying the type of biological tissue based on the temporal change in the repeatedly measured electrical impedance (page 5, lines 2-4; page 11, lines 4-18); and
wherein the identification step comprises:
calculating the amount of change in the electrical impedance within a predetermined period of time (page 3, lines 14-16); and
identifying that the type of biological tissue changes when the calculated amount of change is within a predetermined value range (page 13, lines 8-11).
However, Hoey does not disclose calculating the amount of change in the electrical impedance within a predetermined period of time based on ׀EI2-EI1/ EI1 or ׀EI2-EI1׀/EI2, wherein EI1 is the measured value of the electrical impedance of a first tissue, and EI2 is the measured value of the electrical impedance of a second tissue, when the type of biological tissue located at the tip of the electrode needle changes from the first tissue to the second tissue.
Wong, in the same field of endeavor, teaches a method and apparatus for monitoring and controlling the treatment of tissue by providing real time measurements of the impedance of tissue (pa. 0012). Moreover, Wong teaches calculating the amount of change in the electrical impedance within a predetermined period of time based on
(
Z
i
-
Z
f
)
Z
i
where
Z
i
is the initial impedance and
Z
f
is the final impedance (pa. 0072).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the function of the identification device of Hoey to allow for such calculations described by Wong for the purpose of gathering more accurate feedback necessary to control the application of ablation therapy to the tissue.
However, Hoey/Wong combination do not teach the electrode needle comprising a cylindrical internal electrode needle, a cylindrical external electrode needle covering an outer surface of the internal electrode needle, a first insulation layer located between the internal electrode needle and the external electrode needle, and a second insulation layer covering an outer surface of the external electrode needle, wherein the internal electrode needle comprises a pointed end part that is exposed from the external electrode needle, the external electrode needle comprises an end face that is exposed from the first insulation layer and the second insulation layer, and the pointed end part of the internal electrode needle and the end face of the external electrode needle are arranged in a longitudinal direction at the tip of the electrode needle and function as at least two electrodes.
Schmulewitz, in the same field of endeavor, teaches an electrode needle (21) comprising two or more electrodes disposed on a needle, and operable in a bipolar mode for cauterizing specified volumes of tissue when activated (pa. 0038 & Fig. 1), wherein a distal region (2) of the electrode needle comprises:
a cylindrical internal electrode needle (29);
a cylindrical external electrode needle (28) covering an outer surface of the internal electrode needle (pa. 0042 & Figs. 3-4);
a first insulation layer (42) located between the internal electrode needle and the external electrode needle (pa. 0042); and
a second insulation layer (44) covering an outer surface of the external electrode needle (pa. 0043);
wherein:
the internal electrode needle comprises a pointed end (41) part that is exposed from the external electrode needle (pa. 0045);
the external electrode needle comprises an end face (measured by length LPE as seen in Fig. 3) that is exposed from the first insulation layer and the second insulation layer (pa. 0043), and
the pointed end part of the internal electrode needle and the end face of the external electrode needle are arranged in a longitudinal direction at the tip of the electrode needle and function as at least two electrodes (pa. 0042).
Furthermore, the electrode needle includes a handle comprising a control device (22) with a control circuit (39) (pa. 0048 & Fig. 2A). During the application of energy to the tissue, current flows between the two electrodes on the electrode needle in accordance with Ohm's law (i.e., as the product of (current)2 x (tissue impedance)) (pa. 0061). The impedance is continuously monitored since impedance of tissue increases when it is cauterized, leading to a decrease in the sensed current detected by the control circuit (pa. 0063), helping indicate to a clinician when a treatment is complete. Examiner highlights that while the electrode needle of Schmulewitz is mainly purposed for cauterizing tissue, the electrodes disposed on the device can be in electrical communication with the circuitry that continuously monitors tissue impedance, albeit for purposes only relating to the application of treatment energy to the tissue instead of for identifying tissue type. Nevertheless, the electrodes in the electrode needle of Schmulewitz are still capable of being inserted into living tissue and being connected to a measuring circuitry (such as for example, the measurement device of Hoey) for monitoring/detecting the tissue impedance between the electrodes in order to help the operator identify tissue types.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the needle electrode of Hoey with the needle electrode of Schmulewitz since they are both known equivalents in the art and they would both yield the predictable results of being inserted into living tissue and allowing for the measurement of tissue impedance between two adjacent electrodes on the distal tip of the needle electrode device.
However, Hoey/Wong/Schmulewitz combination do not teach giving notification depending on an identification result.
Paassilta, in the same field of endeavor, teaches a system (1) for determining the position of a needle in an organ, comprising a needle (2) with a distal tip (3), a measurement circuit (4) for measuring the bioimpedance of tissues, a detection means (10) connected to the measurement circuit for measuring bioimpedance and arranged to detect the progress of the distal tip (3) of the needle at a real-time basis from the bioimpedance measured from tissues (abstract & Fig. 1). The system further includes a notification unit/signaling device (12) which produces a visible and/or audible signal when the distal tip of the needle reaches a tissue of a specific type (pa. 0044).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added the notification unit of Paassilta to be in electrical communication with the identification device of Hoey for the purpose of providing a visual/auditory signal to the user to further confirm the location of the needle electrode.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey, Wong, Schmulewitz, and Paassilta as applied to claim 1 above, and further in view of Ko (K.R. Application No. 20190035663 A).
Regarding claim 4, Hoey/Wong/Schmulewitz/Paassilta combination discloses the invention substantially as claimed in claims 1-2 discussed above.
However, they do not teach identifying when the calculated time average is outside a predetermined value range including the reference value.
Ko, in the same field of endeavor, teaches an RF treatment device, a control method of the RF treatment device and a skin treatment method using RF energy (abstract), wherein a controller (5) is able to determine changes in the impedance for a predetermined period, and determine when a parameter value exceeds a threshold value (page 2, line 8, bottom-up; page 5, lines 21-28), and if the parameter value excess the threshold, then the delivery of energy is blocked (page 3, lines 8-10).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included the controller of Ko which identifies whether or not a specific value of interest is outside a predetermined value range, for the purpose of prevent excessive RF energy from being delivered to the tissue (Ko, page 5, lines 1-3).
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 12/31/2025, with respect to the 103 rejection of claims 1, 11, and 12 under Kubodera, Hoey, and Wong have been fully considered and are persuasive. Specifically, Applicant’s amendments to the independent claims to further require the electrode needle to include a cylindrical internal electrode needle, a cylindrical external electrode needle covering an outer surface of the internal electrode needle, a first insulation layer located between the internal electrode needle and the external electrode needle, and a second insulation layer covering an outer surface of the external electrode needle, wherein the internal electrode needle comprises a pointed end part that is exposed from the external electrode needle, the external electrode needle comprises an end face that is exposed from the first insulation layer and the second insulation layer, and the pointed end part of the internal electrode needle and the end face of the external electrode needle are arranged in a longitudinal direction at the tip of the electrode needle and function as at least two electrodes is defined over Kubodera, Hoey, and Wong given that they do not contemplate this claimed structure. Furthermore, Examiner finds the arguments of claims 1, 11-12 regarding the notification unit to be persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, the following new grounds of rejection have been set forth in the action above:
Claims 1-2, 7-12 are rejected under 35 U.S.C. 103 as being unpatentable over Hoey (W.O. Application No. 2001087154 A1), in view of Wong (U.S. Application No. 20020068931 A1), in view of Schmulewitz (E.P. Application No. 1440665 B1), and further in view of Paassilta (U.S. Application No. 20100286507 A1).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hoey, Wong, Schmulewitz, and Paassilta as applied to claim 1 above, and further in view of Ko (K.R. Application No. 20190035663 A).
It is the Examiner’s position that the newly filed rejections based on the combination of references are tenable for at least the reasoning set forth in the action above.
Conclusion
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/A.V.G./Examiner, Art Unit 3794
/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794