DETAILED ACTION
Applicant’s arguments, filed 06/04/2026, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Applicant has amended their claims, filed 06/04/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant has canceled claims 27 and 30-32 and added claims 41 and 42. Claims 21-26, 28-29, and 33-42 are pending and hereby under examination.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 42 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.
Regarding claim 42, it is unclear if “a detector being structure and configured to receive an optical signal from the optical fiber” is the same as the “at least one detector” of claim 37 or an additional detector. For examination purposes, only one detector will be required to meet the claim. However, Applicant should clarify the relationship between the at least one detector of claim 37 and “a detector” of claim 42.
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.
Claims 21-26, 28, 34, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Green (US 20020183582) in view of Hashimshony (US 20030138378).
Regarding claim 21, Green teaches a real-time impedance measuring needle system comprising:
a needle having a distal end, a proximal end, and a fluid channel disposed therethrough, wherein the proximal end and the distal end each include an opening (Figs. 3-5, needle 30 with lumen 31 that extends proximal and distal ends);
at least two conductors disposed near the opening of the distal end of the needle (Figs. 4b-5, conductive traces 32a/b); and
at least one detector configured to sense an electrical current running through a biological tissue disposed between the at least two conductors (Fig. 3, impedance measurement circuitry 42; Paragraph 0041, “conductive trace 32A is electrically coupled to wire 36, and conductive trace 32B is electrically coupled to wire 38. Wires 36 and 38 are coupled to circuitry 43. Voltage source 41 is applied between wires 36 and 38. Impedance measurement circuit 42 continuously measures the impedance between wires 36 and 38. The impedance between wires 36 and 38 indicates how much current is flowing from wire 36 to wire 38. Because wires 36 and 38 are electrically insulated from each other and the tissue except in the tip region, current flows between conductive traces 32A and 32B only at the tip region at the distal end of needle 30”).
Green fails to disclose an optical fiber disposed within the fluid channel including an insulated coating and at least two conductive metallizations, wherein each conductive metallization is individually in electrical communication with a single conductor of the at least two conductors, the at least two conductive metallizations disposed within the insulated coating.
Green and Hashimshony are in the same field of impedance measurement. Hashimshony teaches a tissue impedance measurement device comprising a needle (Figs. 13a/b, biopsy device 300/400 with a probe 320. The probe contains optical fiber 24 with inner coaxial conductors 22 and outer coaxial conductors 21 (Figs. 6a/b). The length of the optical fiber 24 is coated with a silver layer to define the inner conductors 22, and it is then covered with a thick dielectric layer, preferably Teflon (Paragraph 0098; Applicant defines a metallization as a conductor (see Applicant’s specification at page 11, line 10. Thus, Examiner interprets the conductors within the dielectric Teflon layer to read on the “two conductive metallizations … disposed within the insulated coating of the optical fiber”). The inclusion of the optical fiber with the impedance measurement system is useful to produce a more precise indication of the extent of target cells present in the examined tissue (Paragraph 0137). As Green is concerned with obtaining tissue for biopsy, the incorporation of the optical fiber would help Green indicate the amount of target cells present in the tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Green to incorporate the optical fiber as taught by Hashimshony to indicate the amount of target cells present in the tissue being examined.
Regarding claim 22, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses wherein an impedance measurement is derived from the electrical current of the biological tissue disposed between the at least two conductors (Paragraph 0041, “Impedance measurement circuit 42 continuously measures the impedance between wires 36 and 38. The impedance between wires 36 and 38 indicates how much current is flowing from wire 36 to wire 38”).
Regarding claim 23, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses wherein the electrical current between the at least two conductors are one of constant current or alternating current (Paragraph 0041, “Because wires 36 and 38 are electrically insulated from each other and the tissue except in the tip region, current flows between conductive traces 32A and 32B only at the tip region at the distal end of needle 30”; Examiner notes that while constant current or alternating current is not explicitly taught, constant and alternating are the only two types of current. Thus, Green reads on the claim).
Regarding claim 24, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses wherein an indication of a location of the needle is an output of the detector (Paragraph 0042, “This impedance measuring of the present invention assists a clinician's detection of when the distal end of elongated needle 30 projects into the patient's bladder”).
Regarding claim 25, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses wherein the output varies on a resistivity of the biological tissue (Paragraph 0042, “When elongated needle 30 is inserted into the prostate, only a small amount of current flows between conductive traces 32A and 32B through tissue in the prostate, which has a relatively high impedance. The impedance measurement circuit 42 continuously measures a high impedance value while the distal end of elongated needle 30 is advanced through the prostate”).
Regarding claim 26, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses wherein the output further comprises a numerical representation based on the resistance of the biological tissue “Microprocessor 101 preferably causes an indicator to display a metric corresponding to a sensed value of the tissue impedance”).
Regarding claim 28, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses wherein the at least two conductors are on opposing sides of the needle (Fig. 5B – Fig. 6, leads 32A/B on opposite sides of the needle 30).
Regarding claim 34, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses wherein the hollow needle has a flange for contacting the conductor (Paragraph 0041, “Because wires 36 and 38 are electrically insulated from each other and the tissue except in the tip region, current flows between conductive traces 32A and 32B only at the tip region at the distal end of needle 30; Fig. 5, wherein the insulation 44A/B with conductive traces 32A/B forms a “flange”).
Regarding claim 35, the combination of Green and Hashimshony discloses the system according to claim 21. The combination of Green and Hashimshony fail to disclose the optical fiber configured to detect a biomarker of the biological tissue.
However, Hashimshony further discloses wherein a second output is based on an optical signal received by a second detector via the optical fiber, wherein the second detector is configured to detect a biomarker of the biological tissue (Paragraph 0085, “the central optical fiber 24 applies optical pulses from the laser 40 to the central region of the probe area. The voltage pulses produce voltage reflections, and the optical pulses produce optical reflections, both of which are detected by the probe 20”; Paragraph 0128, wherein the light reflections indicate an extent cancerous cell are present). The inclusion of the optical fiber with the impedance measurement system is useful to produce a more precise indication of the extent of target cells present in the examined tissue (Paragraph 0137). As Green is concerned with obtaining tissue for biopsy, the incorporation of the optical fiber would help Green indicate the amount of target cells present in the tissue and if any are cancerous. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Green and Hashimshony to incorporate the optical fiber detecting a biomarker as taught by Hashimshony to indicate the amount of target cells, especially cancerous cells, present in the tissue being examined.
Regarding claim 39, Green discloses a method of measuring tissue impedance in real-time comprising the steps of:
Inserting into a biological tissue a needle having a distal end, a proximal end, and a fluid channel disposed therethrough, wherein the proximal end and the distal end each include an opening (Figs. 3-5, needle 30 with lumen 31 that extends proximal and distal ends);
at least two conductors disposed near the opening of the distal end of the needle (Figs. 4b-5, conductive traces 32a/b); and
at least one detector configured to sense an electrical current running through the biological tissue disposed between the at least two conductors; sensing with the at least one detector an electrical current running through the biological tissue disposed between the at least two conductors (Fig. 3, impedance measurement circuitry 42; Paragraph 0041, “conductive trace 32A is electrically coupled to wire 36, and conductive trace 32B is electrically coupled to wire 38. Wires 36 and 38 are coupled to circuitry 43. Voltage source 41 is applied between wires 36 and 38. Impedance measurement circuit 42 continuously measures the impedance between wires 36 and 38. The impedance between wires 36 and 38 indicates how much current is flowing from wire 36 to wire 38. Because wires 36 and 38 are electrically insulated from each other and the tissue except in the tip region, current flows between conductive traces 32A and 32B only at the tip region at the distal end of needle 30”); and
generating an output based on the electrical current (Paragraph 0052, “Microprocessor 101 preferably causes an indicator to display a metric corresponding to a sensed value of the tissue impedance”).
Green fails to disclose an optical fiber disposed within the fluid channel including an insulated coating and at least two conductive metallizations, wherein each conductive metallization is individually in electrical communication with a single conductor of the at least two conductors, the at least two conductive metallizations disposed within the insulated coating.
Green and Hashimshony are in the same field of impedance measurement. Hashimshony teaches a tissue impedance measurement device comprising a needle (Figs. 13a/b, biopsy device 300/400 with a probe 320. The probe contains optical fiber 24 with inner coaxial conductors 22 and outer coaxial conductors 21 (Figs. 6a/b). The length of the optical fiber 24 is coated with a silver layer to define the inner conductors 22, and it is then covered with a thick dielectric layer, preferably Teflon (Paragraph 0098; Applicant defines a metallization as a conductor (see Applicant’s specification at page 11, line 10. Thus, Examiner interprets the conductors within the dielectric Teflon layer to read on the “two conductive metallizations … disposed within the insulated coating of the optical fiber”). The inclusion of the optical fiber with the impedance measurement system is useful to produce a more precise indication of the extent of target cells present in the examined tissue (Paragraph 0137). As Green is concerned with obtaining tissue for biopsy, the incorporation of the optical fiber would help Green indicate the amount of target cells present in the tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Green to incorporate the optical fiber as taught by Hashimshony to indicate the amount of target cells present in the tissue being examined.
Regarding claim 40, the combination of Green and Hashimshony discloses the system according to claim 21. Green further discloses the step of reposition the needle in response to the output until a desired output is generated (Paragraph 0022, wherein the impedance changes upon the needle penetrating the mucosal lining of the bladder. Thus, the needle would be repositioned until the impedance changes to ensure the needle is in the correct position, i.e., in the bladder).
Regarding claim 41, the combination of Green and Hashimshony disclose the system according to claim 21. Green further discloses a series of conductive arms disposed between the at least two conductors and the at least two conductive metallizations, wherein the series of conductive arms is structured and configured to provide the electrical communication between the at least two conductors and the at least two conductive metallizations (Per Applicant’s specification on Page 11, lines 24-32, the “conductive arm” appears to be the connection between the conductor and the processor or computing device. Green discloses wires 36/38 connected to the conductive traces 32A/B and to the impedance measurement circuitry 42, see Fig. 3. Likewise, Hashimshony also discloses that the conductors 21/22 of the probe 20 are connected to the voltage source 30 and impedance measuring sub-system 60 via connector 26 and a transmission line 28, see Fig. 3. Thus, in combination, Green and Hashimshony read on the claim language as they both disclose connectors between the conductors and processor/computer. In combination, the connectors would necessarily link to the same processing/computing system to provide electrical communication between each other. ).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Green (US 20020183582) and Hashimshony (US 20030138378) as applied to claim 28 above, and further in view of Zhou et. al. (“Ratiometric fluorescence sensor for Fe3+ ions detection based on quantum dot-doped hydrogel optical fiber”), hereinafter Zhou.
Regarding claim 29, the combination of Green and Hashimshony disclose the system of claim 28. The combination fails to disclose the optical fiber having an iron detection coating.
Zhou is pertinent art to the instant application as Zhou is concerned with a coating for detecting iron ions. Zhou teaches a system comprising an optical fiber for the detection of iron ions with a coating sensitive to iron ions (Page 2, paragraph 2). The combination of Green and Hashimshony disclose the optical fiber within a needle, and Zhou teaches the iron ion sensitive coating applied to an optical fiber. The combination would benefit from the iron ion sensitive coating to measure iron in the blood for needle location detection. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Green and Hashimshony to incorporate the iron ion coating taught by Zhou would yield the predictable results of measuring iron in the blood for needle location detection.
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Green (US 20020183582) and Hashimshony (US 20030138378) as applied to claim 21 above and further in view of Ooi (US 20210001042).
Regarding claim 33, Green further discloses wherein the detectors contains at least one processor (Paragraphs 0051-0052). While Green discloses that the needle is preferably attached to a plunger (Paragraph 0038), Green fails to disclose a coupler.
Green, Hashimshony, and Ooi are in the same field of impedance measurement. Ooi teaches a catheter system concerned with determining when a tip of the needle has been inserted into a blood vessel, wherein the system includes a coupler (Figs. 1A-B, adapter 16) which is useful to connect a fluid infusion device to the catheter. The device of Green is concerned with determining when a needle has entered a bladder to deposit seeds and an adapter would be useful to separate the infusion device and the electrode traces measuring the impedance at the tip. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle system of Green, Hashimshony, and Ting to incorporate the adapter taught by Ooi to separate the electrode traces from another attachment.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Green (US 20020183582) and Hashimshony (US 20030138378) as applied to claim 21 above, and further in view of Ting (US 20200289021).
Regarding claim 36, the combination of Green and Hashimshony disclose the system according to claim 21. Green further discloses wherein the at least one detector comprises a circuit board (Fig. 3, impedance measurement circuit 42; Paragraph 0052, “microprocessor 101 preferably causes an indicator to display a metric corresponding to a sensed value of the tissue impedance”). Green fails to explicitly disclose wherein the display is wireless.
Green, Hashimshony, and Ting are in the same field of impedance measurement. Ting teaches a tissue detection device to locate where the apparatus is (Abstract), wherein a communication device can transmit the signals to a processing device wirelessly to determine the impedance (Paragraph 0023) and output wirelessly (Paragraph 0107). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Green to incorporate the wireless transmission of data taught by Ting to process and output data to provide real-time data on a separate device.
Claims 37 and 42 are rejected under 35 U.S.C. 103 as being unpatentable over Green (US 20020183582), Hashimshony (US 20030138378), and Ting (US 20200289021).
Regarding claim 37, Green discloses a real-time impedance measuring needle system comprising:
a needle having a bore, a proximal end, and a lumen disposed therethrough (Figs. 3-5, needle 30 with lumen 31 that extends proximal and distal ends);
at least two conductors disposed at the bore (Figs. 4b-5, conductive traces 32a/b); and
at least one detector, wherein each detector includes at least one processor (Paragraphs 0051-0052, wherein the signals are applied to the microprocessor), and further wherein the at least one detector is configured to sense an electrical current within a biological tissue disposed between the at least two conductors (Fig. 3, impedance measurement circuitry 42; Paragraph 0041, “conductive trace 32A is electrically coupled to wire 36, and conductive trace 32B is electrically coupled to wire 38. Wires 36 and 38 are coupled to circuitry 43. Voltage source 41 is applied between wires 36 and 38. Impedance measurement circuit 42 continuously measures the impedance between wires 36 and 38. The impedance between wires 36 and 38 indicates how much current is flowing from wire 36 to wire 38. Because wires 36 and 38 are electrically insulated from each other and the tissue except in the tip region, current flows between conductive traces 32A and 32B only at the tip region at the distal end of needle 30”).
Green fails to disclose an optical fiber disposed within the fluid channel including an insulated coating and at least two conductive metallizations, wherein each conductive metallization is individually in electrical communication with a single conductor of the at least two conductors, the at least two conductive metallizations disposed within the insulated coating.
Green and Hashimshony are in the same field of impedance measurement. Hashimshony teaches a tissue impedance measurement device comprising a needle (Figs. 13a/b, biopsy device 300/400 with a probe 320. The probe contains optical fiber 24 with inner coaxial conductors 22 and outer coaxial conductors 21 (Figs. 6a/b). The length of the optical fiber 24 is coated with a silver layer to define the inner conductors 22, and it is then covered with a thick dielectric layer, preferably Teflon (Paragraph 0098; Applicant defines a metallization as a conductor (see Applicant’s specification at page 11, line 10. Thus, Examiner interprets the conductors within the dielectric Teflon layer to read on the “two conductive metallizations … disposed within the insulated coating of the optical fiber”). The inclusion of the optical fiber with the impedance measurement system is useful to produce a more precise indication of the extent of target cells present in the examined tissue (Paragraph 0137). As Green is concerned with obtaining tissue for biopsy, the incorporation of the optical fiber would help Green indicate the amount of target cells present in the tissue. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Green to incorporate the optical fiber as taught by Hashimshony to indicate the amount of target cells present in the tissue being examined.
The combination of Green and Hashimshony fail to disclose at least four conductors and at least four conductive metallizations.
Green, Hashimshony, and Ting are in the same field of impedance measurement. Ting teaches a tissue detection and location identification apparatus (Abstract). The device includes two or more electrodes 110’ for measurement (Fig. 1B, wherein four electrodes 110’ are explicitly depicted on the outside of the needle and with electrode 120 shown on the inside). The substitution of two conductors as disclosed by both Green and Hashimshony for the two or more electrodes, with five electrodes explicitly depicted, as taught by Ting would have yielded the predictable results of measuring impedance. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Green and Hashimshony to incorporate four or more electrodes as taught by Ting, and the result of measuring impedance would have been predictable to one of ordinary skill in the art.
Regarding claim 42, the combination of Green, Hashimshony, and Ting disclose the system according to claim 37 above. As discussed above, Green discloses at least one detector and Hashimshony discloses the optical fiber. In combination, the detector would necessarily be configured to measure an optical signal from the optical fiber.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Green (US 20020183582), Hashimshony (US 20030138378), and Ting (US 20200289021) as applied to claim 37 above and further in view of Ooi (US 20210001042).
Regarding claim 38, Green further discloses a detector (Fig. 3, impedance measurement circuitry 42). While Green discloses that the needle is preferably attached to a plunger (Paragraph 0038), Green fails to disclose a coupler.
Green, Hashimshony, Ting, and Ooi are in the same field of impedance measurement. Ooi teaches a catheter system concerned with determining when a tip of the needle has been inserted into a blood vessel, wherein the system includes a coupler (Figs. 1A-B, adapter 16) which is useful to connect a fluid infusion device to the catheter. The device of Green is concerned with determining when a needle has entered a bladder to deposit seeds and an adapter would be useful to separate the infusion device and the electrode traces measuring the impedance at the tip. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the needle system of Green, Hashimshony, and Ting to incorporate the adapter taught by Ooi to separate the electrode traces from another attachment.
Response to Arguments
Applicant’s arguments, see page 6, filed 06/04/2026, with respect to the 35 U.S.C. §112(b) rejections have been fully considered and are persuasive.
Applicant has canceled claim 32; thus, the rejection is withdrawn. Regarding claim 35, Applicant has clarified the language regarding the second output, a second detector, and that the second detector detects a biomarker of the biological tissue. Regarding claim 38, Applicant has amended the claim to provide proper antecedent basis for the “at least one detector”. Lastly, regarding claims 39-40, Applicant has clarified that the “providing” step is the step of inserting the needle. The rejection of the claims has been withdrawn.
Applicant’s arguments, see pages 6-10, filed 06/04/2026, with respect to the rejection(s) of claim(s) 21-40 under 35 U.S.C. §102(a)(1) and 35 U.S.C. §103 have been fully considered and are persuasive. Examiner agrees that Green or Hulvershorn does not teach or suggest “two conductive metallizations” disposed on the inside of the insulative coating of the optical fiber. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Green and Hashimshony described above.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH MICHAEL HEALY whose telephone number is (703)756-5534. The examiner can normally be reached Monday - Friday 8:30am - 5:30pm ET.
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/NOAH M HEALY/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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