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 .
Response to Amendment
The amendment filed February 4th, 2026 has been entered. Claims 1-15, and 18-26 remain pending in the application. Claims 13-15 and 18-25 remain withdrawn from consideration. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Non-Final Office Action mailed January 2nd, 2024.
Response to Arguments
Applicant’s arguments with respect to claims 1-12 and 26 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.
Claims 1-12 and 26 are 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 1, which recites “configured to: use the impedance bridge and a first pair of electrodes of the two or more electrodes to measure at least one impedance of first tissue at a first location relative to the trocar; based on the measured at least one impedance of first tissue, determine a tissue type of the first tissue; use the impedance bridge and a second pair of electrodes of the two or more electrodes to measure at least one impedance of second tissue at a second location relative to the trocar, wherein the first location and second location differ; and based on the measured at least one impedance of second tissue, determine a tissue type of the second tissue.”, there is insufficient support within the specification to support the claim recitation. The specification recites “each of the two or more electrodes 210 is disposed on an outer surface of the distal portion 206 of the awl 202. More specifically, each of the two or more electrodes 210 is disposed at a respective location along a length of the distal portion 206 of the awl 202. While not shown, the two or more electrodes 210 disposed on the distal portion 206 of the awl are coupled to external electrical components 106 by wires. In various embodiments, at least a portion of the wires are imprinted on an outer surface of the awl 202. The external electrical components 106 can generate current at one or more frequencies that is conducted between at least two of the two or more electrodes 210. The external electrical components 106 can record impedance measurements while the current is conducted between at least two of the two or more electrodes 210, the external electrical components 106 (not shown) record impedance measurements between different pairs of the two or more electrodes 210, such as a first impedance measurement of current conducted between a first electrode 210 and a second electrode 210 of the two or more electrodes 210 and a second impedance measurement of current conducted between the second electrode 210 and a third electrode 210 of the two or more electrodes 210. Recording impedance measurements for different pairs of the electrodes 210 while the awl 202 is inserted into a body of a patient can indicate different tissue types of tissue at different portions the location associated with the distal portion 206 of the awl 202, such as tissue types at different depths of the location 102 associated with the distal portion 206 of the awl 202” in Paragraphs[0024]- [0025]. It appears that the processor generates current between a first pair of the two or more electrodes at one or more frequencies to record impedance measurements and then the processor can select a second different pair of electrodes to generate current between and record another, second impedance measurement to indicate different types of tissue at different portions of the tissue at a location associated with the distal portion of the awl. The locations of the first and second measurements appear to be at different depths rather than at different locations (Paragraphs [0024]-[0025]). Further, it is unclear how the processor is configured to “use the impedance bridge” to measure an impedance if the impedance bridge is a load that the processor measures (Paragraph [0045]). The examiner suggests modifying the claim language to recite as such and remove “use the impedance bridge” language to avoid further 112(a) issues. Claims 2-12 and 26 are rejected by virtue of dependency on claim 1.
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 1-7, 9, 11-12, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Halter et al. (US 20160081585 A1) herein referred to as “Halter”.
Regarding claim 1, Halter embodiment 1 discloses a medical device (biopsy sampling device 201, Figure 3), comprising: a trocar including an awl and a cannula (cannula 204, and awl 202, Figure 3, Paragraph [0050]); two or more electrodes disposed on a distal portion of the trocar (electrodes 206, 208, 210, and 212 are formed on a distal end of the trocar cannula 204, Figure 3, Paragraph [0051]); an impedance bridge coupled to the two or more electrodes (impedance measurement apparatus 250 includes at least one measurement unit 256 that couples through cable 226 to at least one different pair of the conductors and associated electrodes 206, 208, 210, 212, Paragraph [0053], Figure 3); and a processor (microprocessor 258 controls measurement unit 256, Paragraph [0053], Figure 3) coupled to the impedance bridge and configured to: use the impedance bridge and a first pair of electrodes of the two or more electrodes to measure at least one impedance of first tissue at a first location relative to the trocar (the impedance measurements are derived by driving a pair of electrodes, such as electrodes 206, 208, while measuring voltages at a different pair of electrodes, such as electrodes 210, 212, Paragraph [0053], Figure 3); based on the measured at least one impedance of first tissue, determine a tissue type of the first tissue (Once 310 all desired samples have been taken, the measured pattern of conductivity, permittivity, and spectral parameters, measured within the organ is compared 312 to patterns of conductivity, permittivity, and spectral parameters of both normal and diseased organs. Pathological examination of samples is also performed 314. Both information from the pattern of impedance and spectral parameters, and from the pathological examinations are used to establish 316 a diagnosis and treatment plan. In this method, the impedance and spectral parameter measurements give additional information about tissue characteristics surrounding an analyzed sample that is useful for diagnosis 316, and in particular useful for estimating tumor size and aggressiveness, Paragraph [0062]).
However Halter embodiment 1 does not explicitly disclose using the impedance bridge and a second pair of electrodes of the two or more electrodes to measure at least one impedance of second tissue at a second location relative to the trocar, wherein the first location and second location differ; and based on the measured at least one impedance of second tissue, determine a tissue type of the second tissue.
Halter embodiment 2 discloses using the impedance bridge and a second pair of electrodes of the two or more electrodes to measure at least one impedance of second tissue at a second location relative to the trocar (in an eight-electrode embodiment electrodes are scanned, by altering a configuration of switching unit 252 under control of processor 258 according to the following table, Figure 4, Paragraph [0055], (i.e., the scanning of the electrode would allow the impedance to be measured at a second location different from the first location, for example first is electrodes 206, and 208, and second is electrodes 270 and 274, Figure 4), wherein the first location and second location differ (first and second location differ based on the scanning of the electrodes, Figure 4, Paragraph [0055]); and based on the measured at least one impedance of second tissue, determine a tissue type of the second tissue ((Once 310 all desired samples have been taken, the measured pattern of conductivity, permittivity, and spectral parameters, measured within the organ is compared 312 to patterns of conductivity, permittivity, and spectral parameters of both normal and diseased organs. Pathological examination of samples is also performed 314. Both information from the pattern of impedance and spectral parameters, and from the pathological examinations are used to establish 316 a diagnosis and treatment plan. In this method, the impedance and spectral parameter measurements give additional information about tissue characteristics surrounding an analyzed sample that is useful for diagnosis 316, and in particular useful for estimating tumor size and aggressiveness, 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 Halter embodiment 1 to incorporate the teachings of Halter embodiment 2 by including using the impedance bridge and a second pair of electrodes of the two or more electrodes to measure at least one impedance of second tissue at a second location relative to the trocar, wherein the first location and second location differ; and based on the measured at least one impedance of second tissue, determine a tissue type of the second tissue. The motivation to do so being to compare the pattern of impedance to that of diseased and normal organs to determine tissue characteristics such as estimating tumor size and aggressiveness for developing a diagnosis and treatment plan (Halter, Paragraph [0062]).
Regarding claim 2, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
However Halter embodiment 1 in view of Halter embodiment 2 does not explicitly disclose wherein the two or more electrodes are disposed on an outer surface of the awl.
Halter embodiment 3 discloses wherein the two or more electrodes are disposed on an outer surface of the awl (multiple electrodes 702, Figure 14).
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 Halter embodiment 1 in view of Halter embodiment 2 to incorporate the teachings of Halter embodiment 3 by including wherein the two or more electrodes are disposed on an outer surface of the awl. The motivation to do so being to use multiple electrodes to compare the pattern of impedance to that of diseased and normal organs to determine tissue characteristics such as estimating tumor size and aggressiveness for developing a diagnosis and treatment plan (Halter, Paragraph [0062]).
Regarding claim 3, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
Halter embodiment 1 further discloses wherein the two or more electrodes are disposed on an outer surface of the cannula (electrodes 206, 208, 210, and 212 are formed on a distal end of the trocar cannula 204, Figure 3, Paragraph [0051]).
Regarding claim 4, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
However Halter embodiment 1 in view of Halter embodiment 2 does not explicitly disclose wherein the two or more electrodes are disposed on an inner surface of the cannula.
Halter embodiment 4 discloses a biopsy sampling device has a trocar with a sampling opening (Abstract) wherein the two or more electrodes are disposed on an inner surface of the cannula (having twisted metal strips that become the electrodes of the biopsy device, the strips shown inside a narrow catheter with an opening, Paragraph [0028], Figure 16).
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 Halter embodiment 1 in view of Halter embodiment 2 to incorporate the teachings of Halter embodiment 4 by including wherein the two or more electrodes are disposed on an inner surface of the cannula. The motivation to do so being to allow for the inner conductors to communicate with tissue surrounding the needle/catheter assembly (Halter, Paragraph [0075]).
Regarding claim 5, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
However Halter embodiment 1 in view of Halter embodiment 2 does not explicitly disclose wherein at least one of the two or more electrodes is disposed on a surface of the awl, and at least another one of the two or more electrodes is disposed on a surface of the cannula.
Halter embodiment 3 discloses wherein at least one of the two or more electrodes is disposed on a surface of the awl (electrodes 702 disposed on a surface of the awl, Figure 14), and at least another one of the two or more electrodes is disposed on a surface of the cannula (electrodes 708 disposed on the surface of the cannula, Figure 14)
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 Halter embodiment 1 in view of Halter embodiment 2 to incorporate the teachings of Halter embodiment 3 by including wherein at least one of the two or more electrodes is disposed on a surface of the awl, and at least another one of the two or more electrodes is disposed on a surface of the cannula. The motivation to do so being to use multiple electrodes to compare the pattern of impedance to that of diseased and normal organs to determine tissue characteristics such as estimating tumor size and aggressiveness for developing a diagnosis and treatment plan (Halter, Paragraph [0062]).
Regarding claim 6, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
Halter embodiment 1 further discloses wherein each of the two or more electrodes is located at a respective location along a length of the trocar (electrodes 206, 208, 210, and 212 are disposed along a length of the trocar, Figures 2 and 3).
Regarding claim 7, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
Halter embodiment 1 further discloses wherein at least one of the two or more electrodes is located on a first side of the trocar, and at least another one of the two or more electrodes is located on a second side of the trocar (see modified Figure 4 below).
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Regarding claim 9, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
Halter embodiment 1 further discloses wherein the device further comprises a display coupled to the processor (microprocessor 258 also drives display 262 with information derived from impedance measurements, Paragraph [0053], Figure 3).
Regarding claim 11, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
However Halter embodiment 1 further discloses wherein the processor selectively couples the impedance bridge to at least two electrodes of the two or more electrodes (microprocessor 258 controls current driver 254 and measurement unit 256, the impedance measurements are derived by driving a pair of electrodes, such as electrodes 206, 208, while measuring voltages at a different pair of electrodes, such as electrodes 210, 212, Paragraph [0053], Figure 3).
Regarding claim 12, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
Halter embodiment 1 further discloses wherein the device comprises a component coupled to the cannula (handle section 203, Figure 3), wherein the component includes at least one of a therapeutic drug delivery tool, an energy delivery tool, a tissue sample extraction tool (handle section 203 slidably controls tissue sampling trocar 202, Paragraph [0050], Figure 3), a pump, or a camera.
Regarding claim 26, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
Halter embodiment 1 further discloses wherein the processor is further configured to, based on the tissue type of the first tissue and the tissue type of the second tissue, determine a size of a tumor or cyst (Once 310 all desired samples have been taken, the measured pattern of conductivity, permittivity, and spectral parameters, measured within the organ is compared 312 to patterns of conductivity, permittivity, and spectral parameters of both normal and diseased organs. Pathological examination of samples is also performed 314. Both information from the pattern of impedance and spectral parameters, and from the pathological examinations are used to establish 316 a diagnosis and treatment plan. In this method, the impedance and spectral parameter measurements give additional information about tissue characteristics surrounding an analyzed sample that is useful for diagnosis 316, and in particular useful for estimating tumor size and aggressiveness, Paragraph [0062]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Halter embodiment 1 in view of Halter embodiment 2 further in view of Honour et al. (US 20070219551) herein referred to as “Honour”.
Regarding claim 8, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
Halter embodiment 1 discloses wherein the device further comprises one or more wires couple the two or more electrodes to the impedance bridge (Impedance measurement apparatus 250 has at least one high frequency alternating-current driver 254 that couple through cable 226 of at least one pair of the electrodes 206, 208, 210, 212, and at least one measurement unit 256 that couples through cable 226 to at least one different pair of the conductors and associated electrodes 206, 208, 210, 212, Paragraph [0053], Figure 3)
However Halter embodiment 1 in view of Halter embodiment 2 does not explicitly disclose wherein at least a portion of the one or more wires is imprinted on a surface of the trocar.
Honour discloses a catheter for conveying signals and/or energy (Abstract) wherein at least a portion of the one or more wires is imprinted on a surface of the trocar (the flexible substrate further defining at least one first conductive trace being arranged generally angularly to the at least one second trace, Paragraph [0031-0033] and [0104]).
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 Halter embodiment 1 in view of Halter embodiment 2 to incorporate the teachings of Honour by including wherein at least a portion of the one or more wires is imprinted on a surface of the trocar. The motivation to do so being to convey the signals from the electrodes through a flexible printed circuit that acts as a wire harness (Honour, Paragraphs [0059]-[0060]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Halter embodiment 1 in view of Halter embodiment 2 further in view of Gerber et al. (US 20070100387) herein referred to as “Gerber”.
Regarding claim 10, Halter embodiment 1 in view of Halter embodiment 2 discloses the medical device of claim 1.
However Halter embodiment 1 in view of Halter embodiment 2 does not explicitly disclose wherein the device further comprises a wireless transmitter coupled to the processor.
Gerber discloses an impedance-based bladder sensing device (Abstract) wherein the device further comprises a wireless transmitter coupled to the processor (processor 81 may receive information related to detected impedance from IMD 18 or module 17 via telemetry interface 87, telemetry interface 87 may be substantially similar to telemetry interface 78 described above, providing wireless communication via an RF or proximal inductive medium, Paragraph [0092]).
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 Halter embodiment 1 in view of Halter embodiment 2 to incorporate the teachings of Gerber by including wherein the device further comprises a wireless transmitter coupled to the processor. The motivation to do so being to wirelessly communicate information related to detected impedance and adjust therapy based on the detected impedance (Gerber, Paragraph [0092]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Shen et al. (US 20200253504) discloses a system for characterizing tissue based on impedance, Ting et al. (US 20200289021) discloses a tissue detection and location identification needle probe, Turer et al. (US 20220273188) discloses a sensing cannula for measuring electrical impedance of tissue to determine the type of tissue in contact with the distal tip, and Kobayashi et al. (US 20220313102) discloses a paracentesis assistance system for identifying the type of biological tissue through measuring the impedance of two electrodes.
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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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.
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/D.S./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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