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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 March 6th, 2026 has been entered.
Response to Amendment
The amendment filed March 6th, 2026 has been entered. Claims 10-20 remain pending in the application. Claims 1-9 remain withdrawn from consideration. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed October 8th, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 10-20 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 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 15, 16, 17, and 18 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.
Claims 15-18 recite the limitation "the one or more operations". There is insufficient antecedent basis for this limitation in the claims.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 10-11 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. (U.S. PGPub. No. 2020/0253504) herein referred to as “Shen” further in view of Waldstreicher et al. (U.S. PGPub. No. 2013/0317339) herein referred to as “Waldstreicher”.
Regarding claim 10, Shen discloses a method for controlling a medical device (system for characterizing tissue and controlling a medical probe 100 to deliver treatment such as cutting or coagulating tissue, Paragraph [0037]),
the method comprising: recording, at one or more frequencies, one or more impedance measurements associated with one or more electrode pairs included in an instrument head of the medical device (probe 100 (medical instrument) includes an electrode assembly 150 comprising one or more probe electrodes 151, wherein the probe 100 is connected to the console 200 for receiving the recorded signals 402, Paragraph [0085], signal generator 210 can be configured to generate one or more specific frequencies or sets of frequencies that can result in enhanced records signals 402, such as frequencies that result in increased differentiation in characteristics of TCI 400, Paragraph [0111], one or more different tissue types are associated with predetermined range of each of a plurality of classification parameters including impedance, Paragraph [0180], system 10 and controller 220 can use one or more of these measurements, and/or calculated quantity such as electrical impedance or resistance of the tissue to produce TCI 400, Paragraph [0195]);
determining, based on the one or more impedance measurements, a tissue type of a portion of tissue contacting the one or more electrode pairs (providing an indication of tissue type and/or other tissue characterization information based on tissue impedance determined by delivering the drive signal, Paragraph [0040], once stored in memory 260, a tissue model can use recorded signals 402 from probe 100 to make real-time predictions of the tissue type, Paragraph [0136], via the tissue characterization information provided by system 10, TCI 400, the system 10 is set to provide a warning as the operator approaches or contacts non-target tissue (e.g. any type of tissue that is not desired to be treated), Paragraphs [0156-0166], system 10 is calibrated by placing the probe electrodes 151 of probe 100 in contact with and/or in known proximity to a first known tissue type and recording the results (e.g. tissue impedance or other characteristic for the same tissue type), and then placing the electrodes 151 in contact with a second tissue type and recording the results, these recordings are then used as a baseline reference value for the particular patient and the tissue characterization for that particular patient can be adjusted based on the results of the calibration, Paragraph [0176]);
However Shen does not explicitly disclose responsive to determining that the determined tissue type of the portion of tissue is a tissue type of a target location, retracting the at least one electrode pair from an extended position to a retracted position such that the medical device tool is prevented from contacting the at least one electrode pair.
Waldstreicher discloses an endobronchial probe (Abstract) wherein the device comprises a retractable biopsy needle (Paragraph [0013]) and a medical device tool (ablation needle, Paragraph [0013]), wherein responsive to determining that the determined tissue type of the portion of tissue is a tissue type of a target location (biopsy needle 50 may be deployed into the target tissue 60, wherein assuming that the evaluation shows that the target 60 is cancerous, the biopsy needle is retracted, Paragraph [0056]), retracting the at least one electrode pair from an extended position to a retracted position such that the medical device tool is prevented from contacting the at least one electrode pair (wherein assuming that the evaluation shows that the target 60 is cancerous, the biopsy needle is retracted, and the ablation needle 52 is deployed to contact the target 60 (i.e., the two needles are prevented from contacting one another), Figure 2 and 5, Paragraph [0056]).
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 Shen to incorporate
the teachings of Waldstreicher by including wherein responsive to determining that the determined tissue type of the portion of tissue is a tissue type of a target location, retracting the at least one electrode pair from an extended position to a retracted position such that the medical device tool is prevented from contacting the at least one electrode pair. The motivation to do so being to identify the target tissue before selectively advancing the ablation needle for treatment (Waldstreicher, Paragraph [0056]).
Regarding claim 11, Shen in view of Waldstreicher discloses the method of claim 10.
Shen further discloses wherein determining the tissue type comprises comparing the one or more impedance measurements to one or more characteristic impedance measurements associated with one or more tissue types (providing an indication of tissue type and/or other tissue characterization information based on tissue impedance determined by delivering the drive signal, Paragraph [0040], via the tissue characterization information provided by system 10, TCI 400, the system 10 is set to provide a warning as the operator approaches or contacts non-target tissue (seen as comparing the one or more impedance values to the TCI 400 comprising the one or more characteristic impedance values associated with one or more tissue types obtained through the calibration described below), Paragraphs [0156-0166], system 10 is calibrated by placing the probe electrodes 151 of probe 100 in contact with and/or in known proximity to a first known tissue type and recording the results (e.g. tissue impedance or other characteristic for the same tissue type), and then placing the electrodes 151 in contact with a second tissue type and recording the results, these recordings are then used as a baseline reference value for the particular patient and the tissue characterization for that particular patient can be adjusted based on the results of the calibration, Paragraph [0176]).
Regarding claim 15, Shen in view of Waldstreicher discloses the method of claim 10.
Shen further discloses wherein the medical device tool comprises a therapeutic drug delivery tool (treatment device 300 and/or a treatment portion of probe 100 (e.g., a functional element 199 configured as a treatment assembly, Paragraph [0123], in some embodiments functional element 99, 199, and/or 399 comprise an element configured to perform a medical treatment including a drug or other agent delivery element, Paragraphs [0145] and [0150]), and performing the one or more operations to control the medical device tool comprises activating the therapeutic drug delivery tool to deliver one or more therapeutic drugs to the portion of tissue (controller 220 provides control signals to control treatment device 300 and/or a treatment portion of probe 100 (e.g., functional element 199 configured as a treatment assembly), for example controller 220 can provide control signals to adjust drug or other agent delivery, Paragraph [0123]).
Regarding claim 16, Shen in view of Waldstreicher discloses the method of claim 10.
Shen further discloses wherein the medical device tool comprises an energy delivery tool (in some embodiments, one or more electrodes 151 of probe 100 are further configured to deliver energy (e.g. configured to deliver drive signals 401 and/or deliver therapeutic energy), Paragraphs [0090] and [0096]) and performing the one or more operations to control the medical device tool comprises activating the energy delivery tool to deliver energy to the portion of tissue (controller 220 provides control signals to control treatment device 300 and/or a treatment portion of probe 100 (e.g., functional element 199 configured as a treatment assembly), for example controller 220 can provide control signals to adjust energy delivery (e.g. adjust the position of one or more portions of probe 100, and/or treatment device 300 delivering treatment energy 300), Paragraphs [0123], [0145], [0148], [0150]).
Regarding claim 17, Shen in view of Waldstreicher discloses the method of claim 10.
Shen further discloses wherein the medical device tool is a tissue sample extraction tool (functional element 99, 199 (of probe 100), and/or 399 comprise an element configured to perform a medical treatment such as a tissue removal element, Paragraph [0145]), and performing the one or more operations to control the medical device tool comprises activating the tissue sample extraction tool to extract a tissue sample from the portion of tissue (calcification occurs in arteries occurs in arteries, tendons, and other structures, and is sometimes removed during a surgical or other clinical procedure, identification of calcification by system 10 (e.g., TCI 400 includes characterization of a tissue as being calcified), can optimize the associated clinical procedures, Paragraph [0162], controller 220 provides control signals to control treatment device 300 and/or a treatment portion of probe 100 (e.g., functional element 199 configured as a treatment assembly, (i.e. tissue removal tool)), for example controller 220 can provide control signals to adjust mechanical cutting parameters, Paragraph [0123]).
Regarding claim 18, Shen in view of Waldstreicher discloses the method of claim 10.
However, Shen does not explicitly disclose wherein the one or more operations further comprise: responsive to determining that the determined tissue type of the portion of tissue is a tissue type of a target location, causing the medical device tool to extend from the retracted position to the extended position.
Waldstreicher discloses wherein the one or more operations further comprise: responsive to determining that the determined tissue type of the portion of tissue is a tissue type of a target location, causing the medical device tool to extend from the retracted position to the extended position (wherein assuming that the evaluation shows that the target 60 is cancerous, the biopsy needle is retracted, and the ablation needle 52 is deployed to contact the target 60 (i.e., medical device tool, ablation needle, is deployed from a retracted position to an extended position once the tissue type is determined to be the target cancerous tissue), Figure 2 and 5, Paragraph [0056]).
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 Shen to incorporate
the teachings of Waldstreicher by including wherein the one or more operations further comprise: responsive to determining that the determined tissue type of the portion of tissue is a tissue type of a target location, causing the medical device tool to extend from the retracted position to the extended position. The motivation to do so being to identify the target tissue before selectively advancing the ablation needle for treatment (Waldstreicher, Paragraph [0056]).
Regarding claim 19, Shen in view of Waldstreicher discloses the method of claim 10.
Shen further discloses wherein the method further comprising outputting at least one of a visual indication or an audio indication of the tissue type of the portion of tissue (providing an indication of tissue type and/or other tissue characterization information based on tissue impedance determined by delivering the drive signal, Paragraph [0040], via the tissue characterization information provided by system 10, TCI 400, the system 10 is set to provide a warning as the operator approaches or contacts non-target tissue ((e.g. via user interface 250 , visual indication)), Paragraphs [0156], system 20 can be configured to provide an alert (e.g. a warning or other notification) as particular types of tissue are identified, Paragraph [0192]).
Regarding claim 20, Shen in view of Waldstreicher discloses the method of claim 10.
Shen further discloses wherein the method comprises outputting at least one of a visual indication or an audio indication that the tissue type of the portion of tissue matches the tissue type of tissue at a target location (system 20 can be configured to provide an alert (e.g. a warning or other notification) as particular types of tissue are identified, for example, a positive feedback (e.g. a green light) can be provided when target tissue is identified (visual indication), Paragraph [0192]).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Shen in view of Waldstreicher further in view of Gregory et al. (U.S. Pat. No. 10,758,151) herein referred to as “Gregory”.
Regarding claim 12, Shen in view of Waldstreicher discloses the method of claim 10.
However Shen in view of Waldstreicher does not explicitly disclose wherein determining the tissue type comprises: determining a Cole relaxation frequency of the portion of tissue based on the one or more impedance measurements, and comparing the Cole relaxation frequency of the portion of tissue to one or more characteristic Cole relaxation frequencies of one or more tissue types.
Gregory discloses a method for detecting cancerous cells in a sample of excised tissue based on impedance detection and Cole relaxation frequencies (Gregory, Abstract). Gregory further discloses wherein determining the tissue type comprises: determining a Cole relaxation frequency of the portion of tissue based on the one or more impedance measurements (computing the Cole relaxation frequency of the target tissue based on impedance measurements, Abstract, Figure 1, Col. 3, lines 17-57), and comparing the Cole relaxation frequency of the portion of tissue to one or more characteristic Cole relaxation frequencies of one or more tissue types (comparing the Cole frequency to that of known cancerous tissue, Col. 3, lines 1-57, Col. 5, lines 12-67).
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 Shen in view of Waldstreicher to incorporate the teachings of Gregory by including wherein determining the tissue type comprises: determining a Cole relaxation frequency of the portion of tissue based on the one or more impedance measurements, and comparing the Cole relaxation frequency of the portion of tissue to one or more characteristic Cole relaxation frequencies of one or more tissue types. The motivation to do so being to determine whether cancerous cells are present in the corresponding section of the excised tissue sample (Gregory, Col. 3, lines 5-10).
Regarding claim 13, Shen in view of Waldstreicher and Gregory discloses the method of claim 12.
However Shen in view of Waldstreicher does not explicitly disclose wherein the Cole relaxation frequency corresponds to a frequency associated with a greatest impedance measurement included in the one or more impedance measurements.
Gregory discloses wherein the Cole relaxation frequency corresponds to a frequency associated with a greatest impedance measurement included in the one or more impedance measurements (the Cole relaxation frequency corresponds to a frequency associated with peak impedance included in the impedance spectrum, Col. 10, lines 37-51).
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 Shen in view of Waldstreicher to incorporate the teachings of Gregory by including wherein the Cole relaxation frequency corresponds to a frequency associated with a greatest impedance measurement included in the one or more impedance measurements. The motivation to do so being to determine the presence or absence of cancerous cells based on the Cole relaxation frequency by comparing the Cole relaxation frequency of the excised tissue to the cancer-detection threshold (Gregory, Col. 10, lines 52-67).
Regarding claim 14, Shen in view of Waldstreicher and Gregory discloses the method of claim 12.
However Shen in view of Waldstreicher does not explicitly disclose wherein determining the tissue type comprises: determining a tumor tissue type based on the Cole relaxation frequency of the portion of tissue being above a threshold frequency, or determining a non-tumor tissue type based on the Cole relaxation frequency of the portion of tissue being below the threshold frequency.
Gregory discloses wherein determining the tissue type comprises: determining a tumor tissue type based on the Cole relaxation frequency of the portion of tissue being above a threshold frequency (computing tissue type of the excised sample based on the Cole relaxation frequency of the target tissue being above a cancer-detection threshold, Col. 5, lines 1-10, Col. 10, lines 37-67),
or determining a non-tumor tissue type based on the Cole relaxation frequency of the portion of tissue being below the threshold frequency (determining a non-cancerous tumor cell group based on the Cole relaxation frequency of the target tissue being below the threshold, Col. 5, lines 1-10).
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 modified Shen in view of Waldstreicher to incorporate the teachings of Gregory by including wherein determining the tissue type comprises: determining a tumor tissue type based on the Cole relaxation frequency of the portion of tissue being above a threshold frequency, or determining a non-tumor tissue type based on the Cole relaxation frequency of the portion of tissue being below the threshold frequency. The motivation to do so being to determine the presence or absence of cancerous cells based on the Cole relaxation frequency by comparing the Cole relaxation frequency of the excised tissue to the cancer-detection threshold (Gregory, Col. 10, lines 52-67).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dana Stumpfoll whose telephone number is (703)756-4669. The examiner can normally be reached 9-5 pm (CT), M-F.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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