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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 1, 11, and 13 are objected to because of the following informalities: syntax and punctuation/mechanic clarifications.
Regarding Claim 1, the limitation "a probe comprising, a probe tip adapted to fit through a laparoscopic port, within the probe tip, the probe comprising" recited in lines 3-4 of the claims are written in a way that causes confusion and doesn't make sense. The current recitation makes it sound like "a probe comprising a probe tip is within a probe tip". It is suggested that the limitation take on a format more similarly to that of the following: "a probe comprising: a probe tip..., the probe tip comprising:.."
Furthermore, it is clearer to separate limitations with a semicolon versus a comma whenever the limitations involve additional parameters/structure. It is recommended that limitations such as those seen between lines 7-8 and 9-10, should be separated by a semicolon instead of the current comma.
Regarding Claim 11, there is an extra space between the terms "plurality" and "of" recited in line 3 of the claim. It is advised that one of these spaces are removed.
Regarding Claim 13, the limitation “where the electrode array comprises” recited in the last line of the claim would be better suited to be written as “tissue; wherein the electrode array”.
Appropriate correction is required.
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.
Claims 1-6, 8-9, 11, 13-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Jersey-Willuhn et. al.'630 (U.S. Patent Publication 20030216630), in view of Davies'764 (U.S. Patent Publication 20080009764), and further in view of Holder et. al.’560 (U.S. Patent Publication 20180092560) as evidenced by Gao et. al.'817 (U.S. Patent Publication 20090325817).
Regarding Claim 1, Jersey-Willuhn et. al.'630 discloses an apparatus for performing bioimpedance measurements on intraoperative boundaries of surgical cavities (Paragraph [0029] - Using the illustrative frame around a site enables a surgeon to map the end of the lesion for discriminating good tissue and cancerous tissue), comprising:
a probe comprising, a probe tip adapted to fit through a laparoscopic port (Paragraph [0117] - biological material by surface measurement of the electrical impedance of the material where the device utilizes a probe with a plurality of measuring electrodes separated by a control electrode), wherein the probe tip comprises:
an array of electrodes, the array of electrodes comprising a plurality of pick-up electrodes and driving electrodes (Paragraph [0120] - The electrode array sensor 500 is useful for sensing techniques including impedance, bio-potential, or electromagnetic field tomography imaging of tissue… The illustrative electrode array 510 has an equal-space geometry of multiple nodes that are capable of functioning as sense and reference electrodes. In a typical tomography application the electrodes are equally-spaced in a circular configuration. Alternatively, the electrodes can have non-equal spacing and/or can be in rectangular or other configurations in one circuit or multiple circuits);
the array of electrodes adapted to couple electrically to an electronics module via a connector (Paragraph [0125] - Individual electrodes in the electrode array 510 are coupled to a signal conditioner/processor including preamplifiers 512 for high gain amplification at high input impedance, low current loading, and low noise);
a force sensor positioned between the electrode array and the electronics module (Paragraph [0140] - Other suitable sensors include, for example, a flow sensor that senses infusion fluid flow, a pressure sensor, a thermistor, thermometer or other temperature sensing device);
the electronics module comprising signaling circuitry including a voltage controlled current source (Paragraph [0089] - The control unit applies a voltage across a first pair of electrodes to induce a signal in a second pair of electrodes and measures impedance at the second pair of electrodes), multiplexing for the driving electrodes (Paragraph [0125] - Band pass filtered signals are applied to a multiplexer 516 that can be part of the signal conditioner/processor to sequentially sample amplified and filtered analog signals from individual electrodes in the electrode array 510), and voltage buffers (Paragraph [0135] - The process involves positioning a three-dimensional electrode array 616 about the object, applying selected voltages to a selected first set of electrodes and measuring currents through a selected second set of electrodes, which may include some or all of the first set);
the electronics module coupled to a data acquisition system; the data acquisition system coupled to a processor (Paragraph [0130] - The electric signal tomogram scanner 600 comprises a signal generator 610, a plurality of boundary condition modules 612, a plurality of data acquisition modules 614, and an electrode array 616. The electric signal tomogram scanner 600 receives control signals from a processor via an interface 618); and
the processor being configured to use the electronics module and the array of electrodes to perform bioimpedance mapping of tissue contacting the electrode array, and to display the bioimpedance mapping tissue contacting the electrode array on a display coupled to the processor (Paragraph [0075] - The processor 220 combines the bio-impedance and optical information and forwards information on tissue condition by a wireless interface card, for example, to one or more display screens; Paragraph [0185] - The system can interrogate at multiple frequencies to map impedance).
Jersey-Willuhn et. al.'630 fails to disclose a plurality of pick-up electrodes surrounded by a plurality of driving electrodes as well as each of the driving electrodes having greater area than each of the pick-up electrodes. Davies'764 teaches driving electrodes that surround pick-up electrodes (Paragraph [0214] - In this configuration there are four current passing electrodes 453 each positioned radially 90.degree. apart. This permits current to be passed and the voltage response to be measured in perpendicular fields; Figure 3). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Jersey-Willuhn et. al.’630 to include driving electrodes that surround an array of pick-up electrodes in order to measure voltages in perpendicular fields as seen in Davies’764. Furthermore, it is noted by the examiner that Davies’764 discloses (Paragraph [0095] - The electrodes in the described methods and apparatus can be used in contact with, in proximity to, over, or inserted into the tissues being examined; Paragraph [0103] - This can be accomplished with an electrode placed in the lumen of an epithelial lined organ (stomach, colon, prostate, bronchus or breast) and with the reference electrode placed outside the lumen of the organ under study).
Holder et. al.’560 teaches some electrodes being larger in area than others (Paragraph [0018] - Some or all of the electrodes may be elongate along an axis of the peripheral nerve, and this can provide increased contact area, lower electrode contact impedance, and improved signal to noise ratio especially given the small size of the nerves to be monitored) as evidence by Gao et. al.'817 that teaches driving electrodes are larger in area than pick-up electrodes (Paragraph [0060] - Drive electrodes 32 are typically larger in surface area than the micron or sub-micron scale sensing and reference electrodes 30; Paragraph [0067] - Since the drive electrode capacitance is in series with the sense electrode interface+probe/target through the solution, preferably the driving electrode area is larger than sensing electrode area to reduce parasitic effects). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Jersey-Willuhn et. al.’630 in view of Davies’764 to include driving electrodes that are larger in area than pick-up electrodes in order to reduce lower contact impedance as well as lower parasitic effects that occur in circuitry as seen in Holder et. al.’560 as evidence by Gao et. al.’817.
Regarding Claim 2, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 1. Jersey-Willuhn et. al.'630 further discloses the array of electrodes couples to the electronics module through a connector (Paragraph [0121] - the electrode array 510 is configured to function as one or more measurement channels. An individual channel includes one or more electrodes that supply current to the tissue at a selected frequency and selected waveform morphology. Another electrode in the channel is a sensing electrode that senses the voltage generated; Paragraph [0125] - Individual electrodes in the electrode array 510 are coupled to a signal conditioner/processor including preamplifiers 512 for high gain amplification at high input impedance, low current loading, and low noise).
Regarding Claim 3, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 1. Jersey-Willuhn et. al.'630 further discloses there are at least 4 driving electrodes (Paragraph [0187] - Four electrodes 1310 are used to apply current to the tissue 1302).
Regarding Claim 4, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 3. Jersey-Willuhn et. al.'630 further discloses there are at least 8 driving electrodes (Paragraph [0187] - Any number of electrodes may be used… a suitable sensor can use 32 or any other number of electrodes).
Regarding Claim 5, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 3. Jersey-Willuhn et. al.'630 further discloses there are at least 25 pick-up electrodes (Paragraph [0187] - Any number of electrodes may be used… a suitable sensor can use 32 or any other number of electrodes).
Regarding Claim 6, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 1. Jersey-Willuhn et. al.'630 further discloses the force sensor configured to measure a force with which the electrode array is pressed against the tissue contacting the electrode array (Paragraph [0140] - Other suitable sensors include, for example, a flow sensor that senses infusion fluid flow, a pressure sensor).
Regarding Claim 8, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 1. Jersey-Willuhn et. al.'630 further discloses a tracker attached to the probe, and a second tracker attachable to a patient within whom the surgical cavity is formed (Paragraph [0055] - In some examples, the sensors 120 contain one or more elements capable of sending and receiving signals from tissue in one or more body locations; Paragraph [0062] - The processor may include a communication program for communicating information to a remote location, enabling remote surveillance of tissue measurements and characteristics).
Regarding Claim 9, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 8. Jersey-Willuhn et. al.'630 further discloses the processor is configured to register a tracked location of the patient to an image obtained from a medical imaging system, to determine a location of the probe tip from the tracked location of the probe module, and to display, on the display coupled to the processor, a superposition of the bioimpedance mapping on the medical image (Paragraph [0104] - In some embodiments, the electrical impedance sensor 400 comprises a plurality of transducers to generate one or more sensor pathways utilizing depth-selective sensing of tissue bio-impedance in a desired frequency range. The bio-impedance sensor 400 generates cross-sectional surface measurements and subcutaneous measurements at one or more selected tissue depths by controlling the field extension of the sensor pathway. Interrogation of various depths occurs by sampling at electrodes positioned at multiple locations; Paragraph [0119] - With multiple groups of electrodes and a capability to measure at a plurality of depths, the sensor has a capability of tomographic imaging or measurement, and/or object recognition).
Regarding Claim 11, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 9. Jersey-Willuhn et. al.'630 further discloses the electronics module is coupled to the processor through a data acquisition system (DAQ) configured to conduct electrical impedance imaging with alternating current at a plurality of frequencies between 100 and 1000000 hertz (Paragraph [0097] - The current source 412 typically injects radio frequency (RF) energy in a suitable range of frequencies, for example from one kilohertz to about one megahertz; Paragraph [0126] - Analog signals from the multiplexer 516 are digitized by an A/D converter 518 that sequentially samples signals from the individual electrodes of the electrode array 510; Paragraph [0156] - For many sensors, a suitable sample frequency may be in a range from 1 to 100 Hertz, although lower or higher sample frequencies may be used).
Regarding Claim 13, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 1. Jersey-Willuhn et. al.'630 further discloses contacting the tissue with an electrode array of the probe of claim 1 (Paragraph [0120] - The electrode array sensor 500 is useful for sensing techniques including impedance, bio-potential, or electromagnetic field tomography imaging of tissue);
sequentially driving at least one of the plurality of the driving electrodes with an alternating current at a plurality of frequencies between 100 and 1000000 hertz while reading the plurality of sense electrodes through analog to digital converters of an electronics module into a processor (Paragraph [0097] - The current source 412 typically injects radio frequency (RF) energy in a suitable range of frequencies, for example from one kilohertz to about one megahertz; Paragraph [0126] - Analog signals from the multiplexer 516 are digitized by an A/D converter 518 that sequentially samples signals from the individual electrodes of the electrode array 510; Paragraph [0127] - Digital signals from the A/D converter 518 can be applied to a processor 520 for analysis, storage 522, and/or display 524; Paragraph [0156] - For many sensors, a suitable sample frequency may be in a range from 1 to 100 Hertz, although lower or higher sample frequencies may be used);
using readings of the sense electrodes to generate a bioimpedance map of the tissue (Paragraph [0075] - The processor 220 combines the bio-impedance and optical information and forwards information on tissue condition by a wireless interface card, for example, to one or more display screens; Paragraph [0185] - The system can interrogate at multiple frequencies to map impedance); wherein
the electrode array comprises at least four driving electrodes (Paragraph [0187] - Four electrodes 1310 are used to apply current to the tissue 1302).
Regarding Claim 14, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the method of Claim 13. Jersey-Willuhn et. al.'630 further discloses there are at least 4 driving electrodes (Paragraph [0187] - Four electrodes 1310 are used to apply current to the tissue 1302).
Regarding Claim 15, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the method of Claim 14. Jersey-Willuhn et. al.'630 further discloses there are at least 8 driving electrodes (Paragraph [0187] - Any number of electrodes may be used… a suitable sensor can use 32 or any other number of electrodes).
Regarding Claim 16, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the method of Claim 13. Jersey-Willuhn et. al.'630 further discloses there are at least 25 pick-up electrodes (Paragraph [0187] - Any number of electrodes may be used… a suitable sensor can use 32 or any other number of electrodes).
Regarding Claim 17, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the method of Claim 16. Jersey-Willuhn et. al.'630 further discloses the tissue is an inner surface of a surgical cavity (Paragraph [0104] - The bio-impedance sensor 400 generates cross-sectional surface measurements and subcutaneous measurements at one or more selected tissue depths by controlling the field extension of the sensor pathway).
Regarding Claim 19, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the method of Claim 16. Jersey-Willuhn et. al.'630 further discloses the tissue is freshly removed from a patient (Paragraph [0074] - The current generator 232 sends current through the hydrogel conductive sensor pathway to the tissue while an ampere meter 234 records data using an analog to digital converter (ADC) and sends the information to the processor 220).
Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Jersey-Willuhn et. al.'630 (U.S. Patent Publication 20030216630), in view of Davies'764 (U.S. Patent Publication 20080009764), and further in view of Holder et. al.’560 (U.S. Patent Publication 20180092560) as evidenced by Gao et. al.'817 (U.S. Patent Publication 20090325817), as applied to Claims 6 and 9 above, and further in view of Yu et. al.'768 (U.S. Patent Publication 20150141768).
Regarding Claim 7, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 1, but fails to disclose a processor is further configured to compare the force with which the electrode array is pressed against the tissue against optimum force limits. Yu et. al.'768 teaches comparing force between an electrode array and a target location of a subject to optimal ranges (Paragraph [0030] - The fiber-optic pressure sensor channel 130 may comprise an interferometric pressure sensor, which may provide real-time pressure data at the interface of the probe tip 144 and the specimen 148, such that an operator or technician can manually control the pressure applied by the tip 144 of the robotic surgical system at the interface within an optimal minimal range. It should be appreciated that the robotic surgical system may be configured to take corrective action automatically based on the pressure detected by the pressure sensor channel 130. This ensures optimal specimen coupling between the probe tip 144 and the specimen 146, so that the surgical robot does not apply unnecessary levels of pressure on the sensor tip 144 that could affect the physiology of the biological tissue specimen 146). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the apparatus of Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 to include comparing force between an electrode array and a target location of a subject to optimal ranges in order to better control guidance and placement of the device as seen in Yu et. al.’768.
Regarding Claim 20, the sections of Yu et. al.’768 cited above disclose an apparatus comprising the elements set forth in the claim.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Jersey-Willuhn et. al.'630 (U.S. Patent Publication 20030216630), in view of Davies'764 (U.S. Patent Publication 20080009764), further in view of Holder et. al.’560 (U.S. Patent Publication 20180092560) as evidenced by Gao et. al.'817 (U.S. Patent Publication 20090325817), further in view of Yu et. al.'768 (U.S. Patent Publication 20150141768), as applied to Claim 7 above, and further in view of Aljuri et. al.'505 (U.S. Patent Publication 20190240505).
Regarding Claim 10, Jersey-Willuhn et. al.'630 in view of Davies'764, further in view of Holder et. al.’560 as evidence by Gao et. al.'817, and further in view of Yu et. al.’768 discloses the apparatus of Claim 7. Jersey-Willuhn et. al.'630 further discloses the electronics module and electrode array form a probe configured to fit through a twelve millimeter diameter laparoscopic port (Paragraph [0089] - In an example of a tissue impedance measuring operation, a caretaker affixes the film barrier dressing 300 so that the electrodes 330 enclose the tip of the needle or catheter; Paragraph [0090] - introducing a cannula or needle into the patient's vascular system), but fails to explicitly disclose a probe of twelve millimeters or less. Aljuri et. al.'505 teaches a probe with a diameter between one and ten millimeters (Paragraph [0078] - Referring to FIG. 1, an exemplary prostatic tissue debulking device 10 constructed in accordance with the principles of the present invention comprises a catheter assembly generally including a shaft 12 having a distal end 14 and a proximal end 16. The shaft 12 will typically be a polymeric extrusion including one, two, three, four, or more axial lumens extending from a hub 18 at the proximal end 16 to locations near the distal end 14. The shaft 12 will generally have a length in the range from 15 cm to 25 cm and a diameter in the range from 1 mm to 10 mm, usually from 2 mm to 6 mm. The shaft will have sufficient column strength so that it may be introduced upwardly through the male urethra, as described in more detail below). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Jersey-Willuhn et. al.'630 in view of Davies'764, further in view of Holder et. al.’560 as evidence by Gao et. al.'817, and further in view of Yu et. al.’768 to include a probe with a diameter of less than twelve millimeters in order to fit inside a user’s urethra and enter a subject’s prostate as seen in Aliuri et. al.’505. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the probe device to be of a diameter less than twelve millimeters, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of the probe is able to access a location such as a prostate of a subject during a minimally invasive procedure. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jersey-Willuhn et. al.'630 (U.S. Patent Publication 20030216630), in view of Davies'764 (U.S. Patent Publication 20080009764), and further in view of Holder et. al.’560 (U.S. Patent Publication 20180092560) as evidenced by Gao et. al.'817 (U.S. Patent Publication 20090325817), as applied to Claim 9 above, and further in view of Aljuri et. al.'505 (U.S. Patent Publication 20190240505).
Regarding Claim 12, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the apparatus of Claim 9. Jersey-Willuhn et. al.'630 further discloses an eight driving electrodes device configured to fit in a small cavity of a subject (Paragraph [0089] - In an example of a tissue impedance measuring operation, a caretaker affixes the film barrier dressing 300 so that the electrodes 330 enclose the tip of the needle or catheter; Paragraph [0090] - introducing a cannula or needle into the patient's vascular system), but fails to disclose where the electrode array is one-third inch in diameter. Aljuri et. al.'505 teaches a catheter-like device that has a diameter between one and ten millimeters (Paragraph [0078] - Referring to FIG. 1, an exemplary prostatic tissue debulking device 10 constructed in accordance with the principles of the present invention comprises a catheter assembly generally including a shaft 12 having a distal end 14 and a proximal end 16. The shaft 12 will typically be a polymeric extrusion including one, two, three, four, or more axial lumens extending from a hub 18 at the proximal end 16 to locations near the distal end 14. The shaft 12 will generally have a length in the range from 15 cm to 25 cm and a diameter in the range from 1 mm to 10 mm, usually from 2 mm to 6 mm. The shaft will have sufficient column strength so that it may be introduced upwardly through the male urethra, as described in more detail below). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 to include an electrode array of one-third inch – around 8.5 millimeters – in order to fit inside a user’s urethra and enter a subject’s prostate as seen in Aliuri et. al.’505. In addition, it would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the probe device to be of a diameter around one-third inches, since applicant has not disclosed that such solves any stated problem or is anything more than one of numerous shapes or configurations, a person of ordinary skill in the art would find obvious for the purpose of the probe is able to access a location such as a prostate of a subject. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Jersey-Willuhn et. al.'630 (U.S. Patent Publication 20030216630), in view of Davies'764 (U.S. Patent Publication 20080009764), and further in view of Holder et. al.’560 (U.S. Patent Publication 20180092560) as evidenced by Gao et. al.'817 (U.S. Patent Publication 20090325817), as applied to Claim 17 above, and further in view of Anderson'561 (U.S. Patent Publication 20100168561).
Regarding Claim 18, Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 discloses the method of Claim 17. Jersey-Willuhn et. al.'630 further discloses a device such as a needle, probe, or catheter configured to enter a subject’s body (Paragraph [0089] - In an example of a tissue impedance measuring operation, a caretaker affixes the film barrier dressing 300 so that the electrodes 330 enclose the tip of the needle or catheter; Paragraph [0090] - introducing a cannula or needle into the patient's vascular system), but fails to explicitly state a device used for a radical prostatectomy procedure. Anderson'561 teaches examples of surgical procedures, such as a prostatectomy, that use probe, needle, and/or catheter devices (Paragraph [0059] - FIG. 1 illustrates an anatomical structure, like the prostate 10, surrounded by other anatomical features that might be damaged during a procedure, such as a radical prostatectomy, because of the proximity to other structures. Procedures include, for example, surgical procedures, minimally invasive procedures, endoscopic procedures, laparoscopic procedures, etc. In the area of the prostate 10, the urethra 20, the neurovascular bundles 30, dorsal vein 40, and bladder 50 can all hamper the ability to surgically access a target surgical site, such as a tumor, during a procedure). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Jersey-Willuhn et. al.'630 in view of Davies'764 and further in view of Holder et. al.’560 as evidence by Gao et. al.'817 to include being used for a prostatectomy in order to observe a subject’s prostate as seen in Anderson’561.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Egorov et. al.'777 (U.S. Patent 8016777) discloses a visualization device used for examining a subject's prostate including pressure sensors.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791