DETAILED ACTION Claims 21-40 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 appl icant regards as his invention. Claim s 32 , 35, and 3 8 -40 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. Regarding claim 32 , it is unclear if the inner conductor and outer conductor are the same as the “at least two conductors” recited in claim 21 or two more conductors, for a total of four conductors. For examination purposes, the claim will be interpreted such that the inner and outer conductors are the same as the “at least two conductors”. Regarding claim 35 , it is unclear what the second output is, how it is calculated or measured, and/or what the system does with the second output. Does the optical fiber also measure impedance, or some other value? For examination purposes, any measurement made by an optical fiber will meet the limitation of the claim. Regarding claim 38, it is unclear if “a detector” is the same as the “at least one detector” of claim 37, or if the claim requires an additional detector with a coupler . For examination purposes, only one detector will be required. Regarding claim 39 , it is unclear as to what or where the “providing” step is providing the needle. What is the needle being “provided” to ? For examination purposes, “providing” will be interpreted to mean “inserting”. Claim 40 is also rejected due to its dependence on claim 39. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. Claims 21-26, 30-31, 34, 36-37, and 39-40 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Green (US 20020183582 – cited by Applicant). Regarding claim 2 1 , 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 ”) . Regarding claim 22 , Green further teaches 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 , Green further teaches 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 , Green further teaches 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 , Green further teaches 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 , Green further teaches 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 30 , Green further teaches the needle having an inner wall, wherein the at least two conductors are insulated from the inner wall and attached thereto or integrated therein ( FIG. 4B , Needle 30 contains conductive traces 32A and 32B with non-conductive insulating material 48 ). Regarding claim 31, Green further teaches wherein the at least two conductors extend along the inner wall of the needle forming a conducting path from the distal end to the proximal end, and further wherein the conducting path connects to a computing device (Fig. 5 and paragraph 0036, “ Needle 30 contains conductive traces 32A and 32B (see FIG. 4B) along its outer circumference ” , wherein the traces connect to impedance measurement circuit 42). Regarding claim 34, Green further teaches 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 37 , Green teaches 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 ”) . Regarding claim 39 , Green teaches a method of measuring tissue impedance in real-time comprising the steps of: providing 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; inserting the needle into the biological tissue; 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 ”) . Regarding claim 40 , Green further teaches 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). 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 27-28 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Green as applied to claim 25 above, and further in view of Hulvershorn (US 20200016373 – cited by Applicant) . Regarding claims 27 -2 8 and 35 , Green discloses wherein the two conductors are on opposing sides of the needle ( Figs. 4b-5, conductive traces 32a/b ). Green fails to disclose an optical fiber disposed within the fluid channel and wherein a second output is based on the optical signal. However, Hulvershorn teaches a medical device comprising a needle with an optical fiber that extends therethrough for measurement (Fig. 5A, needle 20 with sensing elements 300; Paragraph 0111, wherein the sensing elements may comprise one or more optical fibers; Paragraph 0103, wherein the sensing elements measure signals or substances within the needle). Hulvershorn discusses this is useful to measure electrical, biological, or chemic al signals (Paragraph 0111) beyond the probe’s tip within the patient’s body (Paragraph 0103). Green is concerned with measuring the location of the anatomical site the needle is in, and the optical fiber of Hulvershorn measures more signals of the anatomical site the needle is in. 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 optical fiber of Hulvershorn to measure other signals to determine a location of the needle. Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Green and Hulvershorn 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 , Green as modified by Hulvershorn disclose the system of claim 28. The combination fails to disclose the optical fiber having an iron detection coating. However, 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). Green as modified by Hulvershorn disclose the optical fiber within a needle, and Zhou teaches the iron ion sensitive coating applied to an optical fiber. 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 Hulvershorn to incorporate the iron ion coating taught by Zhou would yield the predictable results of measuring iron in the blood for needle location detection. Claims 33 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Green as applied to claim s 21 and 37 above, respectively, and further in view of Ooi (US 20210001042 – cited by Applicant). 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 couple r. However, 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 to incorporate the adapter taught by Ooi to separate the electrode traces from another attachment. 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. However, 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 to incorporate the adapter taught by Ooi to separate the electrode traces from another attachment. Claims 32 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Green as applied to claim 21 above, and further in view of Ting (US 20200289021 – cited by Applicant) . Regarding claim 32, Green further discloses wherein the needle has outer conductors (Figs 5-6, conductive traces 32A-B ). Green fails to disclose an inner conductor. However, Ting teaches a tissue detection device to locate where the apparatus is (Abstract), wherein the needle comprises an inner electrode 120 and an outer electrode 110 separated by an insulative coating 115 (Fig. 1A) such that the electrodes are isolated from each other (Paragraph 0070) and only be exposed at the tip (Paragraph 0073). 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 of Green to incorporate the inner and outer electrodes of Ting such that the electrodes can be isolated from each other except at the tip to detect when the needle enters the tissue. Regarding claim 36, Green further teaches wherein the at least one detector comprises a circuit board ( Fig. 3, impedance measurement circuit 42; Paragraph 0052, “m icroprocessor 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. However, 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 . Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT NOAH MICHAEL HEALY whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-5534 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday - Friday 8:30am - 5:30pm ET . 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, FILLIN "SPE Name?" \* MERGEFORMAT Jason Sims can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-7540 . 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. /NOAH M HEALY/ Examiner, Art Unit 3791 /JASON M SIMS/ Supervisory Patent Examiner, Art Unit 3791