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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 6th, 2026 has been entered.
Response to Amendment
The amendment filed February 6th, 2026 has been entered. Claims 1-13 and 23-24 remain pending in the application. Claims 14, 16, 18, and 21-22 remain withdrawn from consideration.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 claims 1-13 and 23-24 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 the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Regarding claim 23, which recites “wherein determining the tissue type of the tissue comprises determining a frequency, of the two or more different frequencies, of the impedance of the two or more impedances that is the greatest”, however the specification discloses in Paragraph [0040], “the processor can determine a Cole relaxation frequency of the portion of tissue based on the impedance measurements 508, and can compare the Cole relaxation frequency to one or more characteristic Cole relaxation frequencies of one or more tissue types. The Cole relaxation frequency corresponds to a frequency associated with a greatest impedance measurement 508 included in the one or more impedance measurements 508”. It does not appear to support if the frequency can contain the two or more different frequencies as mentioned in Claim 23 and is the same as the Cole relaxation frequency as mentioned in Paragraph [0040] of the specification. The examiner suggests modifying the claim language to reflect the language as described in the specification to ensure there is support for the claim language.
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.
Claim 24 is 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 “a needle, and two or more electrodes disposed on the needle; .. wherein the processor is configured to (i) use the impedance bridge to measure two or more impedances, at respective two or more different frequencies, of tissue, and (ii) based on the two or more impedances, determine a tissue type of the tissue”. Claim 24 recites “wherein the instrument head further comprises a sheath and an actuator, and wherein the processor is further configured to, responsive to determining that the tissue type of the tissue matches an expected tissue type, operate the actuator to retract the sheath, thereby exposing the needle”, however it is unclear as to how the needle device of claim 1 can record impedances of the tissue if the needle is not deployed from the sheath of the device until the tissue type is determined. Is the needle deployed to a certain depth for measuring the impedances of the tissue and then deployed further once the tissue type is determined? Further clarification is needed within the claims to determine as to how the device performs these functions.
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 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Tu et al. (U.S. PGPub. No. 20030088189) herein referred to as “Tu” in view of Richardson et al. (U.S. PGPub. No. 20130123778) herein referred to as “Richardson”.
Regarding claim 1, Tu discloses a medical device (medical probe 11, Paragraph [0048], Figures 1-3), comprising:
an instrument head (distal end 12 of medical probe 11, Figure 1, Paragraph [0048]) that includes:
a needle (needle probe, Paragraph [0019], Figures 1-3),
and two or more electrodes disposed on the needle (electrodes 31, 32, 33, Paragraph [0053]-[0055], Figures 1-3);
an impedance bridge coupled to the two or more electrodes (impedance bridge between two electrodes 31, 32, Paragraphs [0052] and [0050]);
and a processor coupled to the impedance bridge (the measured impedance is fed to an external monitor 19 (seen as a processor), Figure 1, Paragraphs [0053] and [0059]).
However Tu does not explicitly disclose wherein the processor is configured to (i) use the impedance bridge to measure two or more impedances, at respective two or more different frequencies, of tissue, and (ii) based on the two or more impedances, determine a tissue type of the tissue.
Richardson discloses wherein the processor is configured to (i) use the impedance bridge to measure two or more impedances, at respective two or more different frequencies, of tissue, and (ii) based on the two or more impedances, determine a tissue type of the tissue (the sensing electrodes 214, 216 may be used to monitor the impedance of the tissue separating them, various frequencies may be used to determine on or more impedance values, the impedance measurements may be used to determine which tissues are in the local ablation region, the use of various frequencies may allow for better discrimination between tissue types, Paragraph [0046]).
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 Tu to incorporate
the teachings of Richardson by including wherein the processor is configured to (i) use the impedance bridge to measure two or more impedances, at respective two or more different frequencies, of tissue, and (ii) based on the two or more impedances, determine a tissue type of the tissue. The motivation to do so being to use the impedance measurements to determine which tissues are in the location ablation region (Richardson, Paragraph [0046]).
Regarding claim 2, Tu in view of Richardson discloses the medical device of claim 1.
Tu further discloses wherein each of the two or more electrodes is located at a respective location along a length of the needle (each of the electrodes 31, 32, 33 are disposed at a respective location along the length of the needle, Figures 1-3).
Regarding claim 3, Tu in view of Richardson discloses the medical device of claim 1.
Tu further discloses wherein at least one of the two or more electrodes is located on a first side of the needle (first electrode 31 is located on a first side of the needle, see modified Figure 2 below), and at least another one of the two or more electrodes is located on a second side of the needle (second electrode 32 is located on a second side of the needle, see modified Figure 2 below, wherein the impedance measuring electrodes are spaced apart circumferentially, Paragraph [0049]).
PNG
media_image1.png
643
664
media_image1.png
Greyscale
Claims 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richardson further in view of Miesel et al. (U.S. PGPub No. 20140276573) herein referred to as “Miesel”.
Regarding claim 4, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein at least one of the two or more electrodes encircles the needle.
Miesel discloses a medical device (apparatus 200, Figure 2A), wherein at least one of the two or more electrodes (electrodes 261, 262, 263, Figure 2B) encircles the needle (electrode 261 encircles the needle 260 (annular electrode), Paragraph [0061], claim 4, Figure 2B).
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 Tu in view of Richardson to incorporate the teachings of Miesel by including wherein at least one of the two or more electrodes encircles the needle. The motivation to do so being to ensure the electrodes extend around the perimeter of the shaft (Miesel, Paragraphs [0061]-[0062]).
Regarding claim 5, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein at least one of the two or more electrodes is located on a tip of the needle.
Miesel discloses wherein at least one of the two or more electrodes is located on a tip of the needle (electrode 261 is located on the distal tip, Paragraph [0035], claim 4).
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 Tu in view of Richardson to incorporate the teachings of Miesel by including wherein at least one of the two or more electrodes is located on a tip of the needle. The motivation to do so being to place the electrodes in the distal most subcutaneous tissue (Miesel, Paragraph [0039]).
Regarding claim 6, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein the needle includes an electrically insulating material that is located between at least two of the two or more electrodes.
Miesel discloses wherein the needle includes an electrically insulating material that is located between at least two of the two or more electrodes (at least one nonconductive layer overlaying the conductive wall, the second 262 and third electrodes 263 being formed on the at least one nonconductive layer(seen as insulating material between at least two of the two or more electrodes), claim 4),
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 Tu in view of Richardson to incorporate the teachings of Miesel by including wherein the needle includes an electrically insulating material that is located between at least two of the two or more electrodes. The motivation to do so being to electrically isolate the electrodes from one another to prevent interference (Miesel, Paragraph [0043]).
Regarding claim 7, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein the needle includes an electrically insulating material, and each of the two or more electrodes is disposed on top of the electrically insulating material.
Miesel discloses wherein the needle includes an electrically insulating material, and each of the two or more electrodes is disposed on top of the electrically insulating material (at least one nonconductive layer overlaying the conductive wall, the second 262 and third electrodes 263 being formed on the at least one nonconductive layer (i.e., the electrodes are disposed on top of the electrically insulating material), claim 4, Paragraph [0036], Figure 2B).
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 Tu in view of Richardson to incorporate the teachings of Miesel by including wherein the needle includes an electrically insulating material, and each of the two or more electrodes is disposed on top of the electrically insulating material. The motivation to do so being to electrically isolate the electrodes from one another to prevent interference (Miesel, Paragraph [0043]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richardson in view of Long et al. (U.S. PGPub No. 20110190659) herein referred to as “Long”.
Regarding claim 8, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein the needle includes an electrically insulating material, and each of the two or more electrodes is disposed within a different carve-out within the electrically insulating material.
Long discloses a medical device (surgical instrument , Figure 4, Paragraph [0060]), wherein the needle includes an electrically insulating material (biopsy punch 200, wherein the shaft of the punch includes one or more electrically insulating materials, Figure 4, Paragraphs [0060] and [0064]), and each of the two or more electrodes (electrodes 224a, 224b, Figure 5) is disposed within a different carve-out within the electrically insulating material (the electrodes are formed within the grooves 244a, 244b of the shaft, Paragraph [0063]-[0064], Figure 5).
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 Tu in view of Richardson to incorporate the teachings of Long by including wherein the needle includes an electrically insulating material, and each of the two or more electrodes is disposed within a different carve-out within the electrically insulating material. The motivation to do so being to ensure that there is no relative movement between the electrodes and the shaft (Long, Paragraphs [0061]-[0062]).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richardson in view of Kenan et al. (WO 2009019707) herein referred to as “Kenan”.
Regarding claim 9, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein one or more of the two or more electrodes is disposed on an interior surface of a cannula of the needle.
Kenan teaches a medical device (device 100, Figure 1) wherein one or more of the two or more electrodes (electrodes E1, E2, Figure 4A) is disposed on an interior surface (electrodes E1, and E2 extends along the needle inside the needles lumen, Page 17, lines 5-8) of a cannula of the needle (needle 109 defines a cannula, Figure 4A).
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 Tu in view of Richardson to incorporate the teachings of Kenan by including wherein one or more of the two or more electrodes is disposed on an interior surface of a cannula of the needle. The motivation to do so being to provide more accurate impedance measurements (Kenan, Page 17, lines 24-25).
Regarding claim 10, Tu in view of Richardson discloses the medical device of claim 1.
Tu in view of Richardson discloses a first cannula wherein the two or more electrodes are disposed on the first cannula (opening 39 defines a cannula of the needle, wherein electrodes 31 and 32 are disposed on the cannula, Figure 2, Paragraph [0056]).
However Tu in view of Richardson does not explicitly disclose wherein the needle includes a second cannula that resides within the first cannula, and the two or more electrodes are disposed on the second cannula.
Kenan discloses wherein the needle includes a first cannula (first cannula is needle 109, Figure 4A) and a second cannula that resides within the first cannula (catheter 112 resides within the first cannula 109, Figure 4A), and the two or more electrodes are disposed on the first cannula or the second cannula (the electrodes are carried by the needle or the catheter, Page 17, lines 5-6).
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 Tu in view of Richardson to incorporate the teachings of Kenan by including wherein the needle includes a second cannula that resides within the first cannula, and the two or more electrodes are disposed on the second cannula. The motivation to do so being to provide more accurate impedance measurements (Kenan, Page 17, lines 24-25).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richardson in view of Toth et al. (U.S. PGPub No. 20150289929) herein referred to as “Toth”.
Regarding claim 11, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein the instrument head includes a sheath, and the needle selectably extends by an adjustable amount relative to the sheath.
Toth discloses a medical device (probe 1512, Figure 15A) wherein the instrument head includes a sheath (probe 1512 defines an instrument head surrounded by sheath 1516, Figure 15A), and the needle selectably extends by an adjustable amount relative to the sheath (needle shaft 1515 is deployed from sheath 1516, Paragraph [0332], Figure 15A).
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 Tu in view of Richardson to incorporate the teachings of Toth by including disclose wherein the instrument head includes a sheath, and the needle selectably extends by an adjustable amount relative to the sheath. The motivation to do so being to provide a stable base from which the probe shaft may protrude out into the wall of the lumen (Toth, Paragraph [0332]).
Regarding claim 12, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein the instrument head includes a sheath that selectably extends by an adjustable amount relative to the needle.
Toth discloses wherein the instrument head includes a sheath that selectably extends by an adjustable amount relative to the needle (needle shaft 1515 is deployed from sheath 1516 (i.e., in order for the shaft 1515 to be deployed the sheath 1516 must selectably extend by an adjustable amount relative to the needle shaft 1515), Paragraph [0332], Figure 15A).
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 Tu in view of Richardson to incorporate the teachings of Toth by including disclose wherein the instrument head includes a sheath that selectably extends by an adjustable amount relative to the needle. The motivation to do so being to provide a stable base from which the probe shaft may protrude out into the wall of the lumen (Toth, Paragraph [0332]).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richardson in view of Bek et al. (U.S. PGPub No. 20140324065) herein referred to as “Bek”.
Regarding claim 13, Tu in view of Richardson discloses the medical device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein the instrument head includes a sheath that has one or more carve-outs, and the sheath selectably rotates between a first rotational position, in which the one or more carve-outs exposes at least one of the two or more electrodes, and a second rotational position, in which the sheath covers the at least one of the two or more electrodes.
Bek discloses a medical device (probe 700, Figures 16B-16C and 20B, Paragraphs [0082] and [0089]) wherein the instrument head includes a sheath that has one or more carve-outs (outer sleeve 705 comprises window 712 (seen as a carve out), Figures 16B-16C, Paragraph [0082]), and the sheath selectably rotates between a first rotational position, in which the one or more carve-outs exposes at least one of the two or more electrodes (sleeve 715 is rotated in two different rotational positions with respect to the outer sleeve 705 and window 712, Paragraph [0082], Figures 16B-16C, wherein the inner sleeve 715 rotates to the window to expose electrode 725, Figure 16B), and a second rotational position, in which the sheath covers the at least one of the two or more electrodes (second rotational position, sheath 705 covers at least one of the electrodes, Figures 16C and 20B, Paragraph [0082] and [0089]).
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 Tu in view of Richardson to incorporate the teachings of Bek by including disclose wherein the instrument head includes a sheath that selectably extends by an adjustable amount relative to the needle. The motivation to do so being to operate the electrode in a specific mode when the electrode is exposed in the window and when the window is closed (Bek, Paragraph [0089])
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richardson in view of Gregory et al. (U.S. PGPub No. 20190216358) herein referred to as “Gregory”.
Regarding claim 23, Tu in view of Richardson discloses the device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein determining the tissue type of the tissue comprises determining a frequency, of the two or more different frequencies, of the impedance of the two or more impedances that is the greatest.
Gregory discloses wherein determining the tissue type of the tissue comprises determining a frequency, of the two or more different frequencies, of the impedance of the two or more impedances that is the greatest (analyzer 121 computes the Cole relaxation frequency 414 by generating the negative of the reactive component of the impedance spectrum 412 and determining the frequency corresponding to the peak of the curve, the analyzer 121 compares the Cole relaxation frequency with cancer presence threshold 416, Paragraph [0061], analyzer 121 could determine that the section of the excised tissue sample likely contains malignant cells because Cole relaxation frequency 414 exceeds cancer presence threshold 416, tissue sample does not contain any malignant cancer cells, Paragraph [0062]).
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 Tu in view of Richardson to incorporate the teachings of Gregory by including wherein determining the tissue type of the tissue comprises determining a frequency, of the two or more different frequencies, of the impedance of the two or more impedances that is the greatest. The motivation to do so being to determine if tissue in contact with the device comprises cancer cells (Gregory, Paragraphs [0060]-[0064]).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richardson in view of Lichtenstein et al. (U.S. PGPub No. 20180153467) herein referred to as “Lichtenstein”.
Regarding claim 24, Tu in view of Richardson discloses the device of claim 1.
However Tu in view of Richardson does not explicitly disclose wherein the instrument head further comprises a sheath and an actuator, and wherein the processor is further configured to, responsive to determining that the tissue type of the tissue matches an expected tissue type, operate the actuator to retract the sheath, thereby exposing the needle.
Lichtenstein discloses wherein the instrument head further comprises a sheath and an actuator, and wherein the processor is further configured to, responsive to determining that the tissue type of the tissue matches an expected tissue type, operate the actuator to retract the sheath, thereby exposing the needle (there is a depth sensing mechanism, for example, to determine a depth of tip 204 in the tissue and/or to ensure that tip 204 does not penetrate into, for example, a lumen or tissue which is not target tissue, the heart it may be desirable to avoid penetrating to a pericardial space, in some embodiments, impedance sensing (e.g., between electrodes 206) is used to identify the tissue at the tip 204, Paragraph [0218], tube surrounding the helix can be selectively advanced to control insertion depth of the helix, Paragraph [0134]).
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 Tu in view of Richardson to incorporate the teachings of Lichtenstein by including wherein the instrument head further comprises a sheath and an actuator, and wherein the processor is further configured to, responsive to determining that the tissue type of the tissue matches an expected tissue type, operate the actuator to retract the sheath, thereby exposing the needle. The motivation to do so being to avoid penetrating into a lumen or tissue that is not the target tissue (Lichtenstein, Paragraph [0218]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794