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 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.
Claims 1-20 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 1, the phrase “the probe tip” in line 12 lacks proper antecedent basis. This limitation is being interpreted as “a tip of the probe”.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
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 1-4, 6, 8-9, 11, 13-14, and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson'561 (U.S. Patent Publication 20100168561 – previously cited), in view of Gao et. al.'817 (U.S. Patent Publication 20090325817 – previously cited), and further in view of Ogata et. al.'547 (U.S. Patent Publication 20210251547).
Regarding Claim 1, Anderson'561 discloses an apparatus for performing bioimpedance measurements on intraoperative boundaries of surgical cavities (Paragraph [0084] - For example, a probe comprising an electrode array combined with an ink-jet print head marks the tissue in response to the impedance), comprising:
a probe (Paragraph [0060] - The sensing element can be placed on the probe, at any suitable location within the system, or at some other location of the body, if desired) comprising:
an electronics module (Paragraph [0090] - interrogation element 522… interrogation element can be a stimulator),
an array of electrodes, the array of electrodes comprising a plurality of pick-up electrodes surrounded by a plurality of driving electrodes (Paragraph [0084] - a probe comprising an electrode array; Paragraph [0087] - a mapping array may, for example, comprise a primary electrode 511, and a plurality of secondary electrodes 513 arranged in a plane around the primary electrode 511; Paragraph [0087] - The primary electrode can, for example, be one or more excitation elements while the secondary electrode can be one or more sensing electrodes);
the array of electrodes adapted to couple electrically to the electronics module via a connector (Paragraph [0090] - interrogation element can be a stimulator such as a vibration source used to stimulate a sensory nerve that is monitored using the interrogation element 523; Figures 10a-10b);
a force sensor positioned between the electrode array and the electronics module (Paragraph [0094] - This can be accomplished using a sensing element that is an accelerometer, pressure sensor, stress sensor, or optical sensor); wherein
the probe tip is adapted to fit through a laparoscopic port (Paragraph [0011] – In some configurations, the device can be adapted and configured for use in, for example, laparoscopic or minimally invasive surgery and by comprising a catheter for deploying the reference element; Paragraph [0059] - 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; Figure 9b);
the electronics module comprising signaling circuitry including a voltage controlled current source, multiplexing for the driving electrodes, and voltage buffers (Paragraph [0091] - an alternating voltage signal can be provided to an electrode pair while monitoring the passage of the electrical current between the electrodes);
the electronics module coupled to a data acquisition system (Paragraph [0090] - A remote interrogation element 522 is in communication with the mapping system controller 501; Paragraph [0091] - The mapping system herein maps an area of tissue during a surgical procedure by detecting the properties of adjacent tissue as evaluated by analyzing the characteristics of an electrical signal generated between the excitation element and the sensing element);
the data acquisition system coupled to a processor (Paragraph [0071] - The marking can also include, for example, projected light such as scanned laser images or projected images from a projector or Digital mirror display (DMD), or on a computer monitor or other appropriate display of the TUT where the marking comprises a digital record of marked TUT locations in a data base);
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 [0015] - Furthermore, in some aspects, the location of the detectable mark might be stored in a computer, projected on a digital display, or used with a computerized surgical system; Paragraph [0071] - The marking can also include, for example, projected light such as scanned laser images or projected images from a projector or Digital mirror display (DMD), or on a computer monitor or other appropriate display of the TUT where the marking comprises a digital record of marked TUT locations in a data base; Paragraph [0084] - For example, a probe comprising an electrode array combined with an ink-jet print head marks the tissue in response to the impedance).
Anderson'561 fails to disclose each of the driving electrodes having greater area than each of the pick-up electrodes. Gao et. al.'817 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 Anderson'561 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 Gao et. al.’817.
Anderson'561 fails to disclose wherein the electronics module, the array of electrodes, and the force sensor are located within the probe tip. Ogata et. al.'547 teaches a processor (an electronics module) positioned within a probe (Paragraph [0119] - The probe 20 is formed in a substantially rod-like shape and connects the sensor 10 and the grip 30. The biosensor 11 is arranged in the sensor 10. The pressing force detection component 12 is arranged in the sensor 10. The processor 21 is arranged in the probe 20. Such configuration facilitates the detection of the pressing force P produced when the biosensor 11 makes contact with a part to be measured. This further improves the measurement accuracy. Furthermore, by arranging the processor 21 in the probe 20, the occurrence of noise in the processor 21 can be suppressed). 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 Anderson'561 to include a processor (electronics module) alongside the array of electrodes and the force sensor to be located within the probe tip in order to improve measurement accuracy and reduce occurrence of noise as seen in Ogata et. al.'547.
Regarding Claim 2, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 1 above. Anderson'561 further discloses the array of electrodes couples to the electronics module through a connector (Paragraph [0088] - An electrical interface 515, as shown in FIG. 9B provides communication between the marking system controller and the mapping array 510; Figure 9b).
Regarding Claim 3, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 1 above. Anderson'561 further discloses there are at least 4 driving electrodes (Figure 9a; Paragraph [0087] - the primary 511 and secondary electrodes 513 are located around the dispensing aperture 153…the secondary electrodes can be one or more excitation electrodes).
Regarding Claim 4, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 3 above. Anderson'561 further discloses there are at least 8 driving electrodes (Figure 9a; Paragraph [0087] - the primary 511 and secondary electrodes 513 are located around the dispensing aperture 153…the secondary electrodes can be one or more excitation electrodes).
Regarding Claim 6, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 1 above. Anderson'561 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 [0094] - The mapping system can also be configured to map the TUT by measuring other tissue characteristics besides electrical impedance. The excitation element provides an electrical stimulus to the target tissue. The sensing element can then measure the, e.g., mechanical displacement of the tissue, such as a contraction of muscle fibers in response to the excitation element stimulus. This can be accomplished using a sensing element that is an accelerometer, pressure sensor, stress sensor, or optical sensor).
Regarding Claim 8, Anderson'561 in view of Gao et. al.'817, further in view of Ogata et. al.'547 discloses the apparatus of Claim 1 above. Anderson’561 further discloses a tracker attached to the probe, and a second tracker attachable to a patient within whom the surgical cavity is formed (Paragraph [0093] - The electrical impedance of the TUT can then be measured between the excitation element and the remote interrogation element. The excitation electrode is a moveable electrode. A mapping system with a monopolar format may comprise of a plurality of excitation electrodes. Additionally, the plurality of excitation electrodes can be adapted and configured such that the electrodes are moveable).
Regarding Claim 9, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 8 above. Anderson'561 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 [0071] - The marking can also include, for example, projected light such as scanned laser images or projected images from a projector or Digital mirror display (DMD), or on a computer monitor or other appropriate display of the TUT where the marking comprises a digital record of marked TUT locations in a data base).
Regarding Claim 11, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 9 above. Anderson'561 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 [0092] - The frequency of the voltage used with the excitation element can be more than about 10 Hz, more than about 30 Hz, more than about 50 Hz, more than about 100 Hz, more than 500 Hz, more than 1000 Hz, more than about 5 kHz, more than about 10 kHz, more than about 50 kHz, more than about 100 kHz, more than about 500 kHz, or more than about 800 kHz. In other cases, the voltage between the excitation element and the sensing element can be less than about 1000 kHz).
Regarding Claim 13, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 1 above. Anderson'561 further discloses contacting the tissue with an electrode array of the probe of claim 1 (Paragraph [0084] - a probe comprising an electrode array; Paragraph [0087] - a mapping array may, for example, comprise a primary electrode 511, and a plurality of secondary electrodes 513 arranged in a plane around the primary electrode 511);
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 [0092] - The frequency of the voltage used with the excitation element can be more than about 10 Hz, more than about 30 Hz, more than about 50 Hz, more than about 100 Hz, more than 500 Hz, more than 1000 Hz, more than about 5 kHz, more than about 10 kHz, more than about 50 kHz, more than about 100 kHz, more than about 500 kHz, or more than about 800 kHz. In other cases, the voltage between the excitation element and the sensing element can be less than about 1000 kHz);
using readings of the sense electrodes to generate a bioimpedance map of the tissue (Paragraph [0060] - The excitation element can be adapted and configured to, for example, create a signal that is detected by a sensing element for mapping a location of target tissues or vessels. The sensing element can include, for example, a device that is adapted and configured to detect a signal); wherein
the electrode array comprises at least four driving electrodes (Figure 9a; Paragraph [0087] - the primary 511 and secondary electrodes 513 are located around the dispensing aperture 153…the secondary electrodes can be one or more excitation electrodes).
Regarding Claim 14, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the method of Claim 13 above. Anderson'561 further discloses there are at least 8 driving electrodes (Figure 9a; Paragraph [0087] - the primary 511 and secondary electrodes 513 are located around the dispensing aperture 153…the secondary electrodes can be one or more excitation electrodes).
Regarding Claim 16, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the method of Claim 13 above. Anderson'561 further discloses comprising using the bioimpedance map of tissue to classify the tissue (Paragraph [0020] - The marking element can be further adapted and configured to create multiple detectable marks on the tissue of interest. Each of the multiple detectable marks can further identify multiple different types of tissues. Furthermore, different types of marking elements can be used to mark each of the discrete tissue types such that the sensory signal enables the user to distinguish between the different tissue types; Paragraph [0084] - For example, a probe comprising an electrode array combined with an ink-jet print head marks the tissue in response to the impedance).
Regarding Claim 17, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the method of Claim 16 above. Anderson'561 further discloses wherein the tissue is an inner surface of a surgical cavity (Paragraph [0011] - In some configurations, the device can be adapted and configured for use in, for example, laparoscopic or minimally invasive surgery and by comprising a catheter for deploying the reference element; Paragraph [0097] - Also provided herein is a system for mapping an area of tissue during a surgical procedure).
Regarding Claim 18, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the method of Claim 17 above. Anderson'561 further discloses the surgical cavity is created during a radical prostatectomy procedure (Paragraph [0117] - Another proximity system could be used to target a dissection of an interface between the neurovascular bundles 30 and the prostate 10 FIG. 3, during radical prostatectomy).
Regarding Claim 19, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the method of Claim 16 above. Anderson'561 further discloses the tissue is freshly removed from a patient (Paragraph [0075] - FIG. 4B illustrates a generalized surgical site where a selective-dissection probe 195 of a selective-dissection system is used to remove tissue 5 while preserving target structures 2 at the TUT 1 site. The purpose of the selective-dissection-system is to enable tissue dissection by the surgeon, while protecting the target structures of the surgical site; Paragraph [0114] - Alternatively, tissue can be selectively removed by, for example, marking a tissue of interest with a detectable mark using a marking element).
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson'561 (U.S. Patent Publication 20100168561 - previously cited), in view of Gao et. al.'817 (U.S. Patent Publication 20090325817 - previously cited), further in view of Ogata et. al.'547 (U.S. Patent Publication 20210251547), as applied to Claims 3 and 14 above respectively, and further in view of Jersey-Willuhn et. al.'630 (U.S. Patent Publication 20030216630 - previously cited).
Regarding Claim 5, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 3 above. Anderson'561 further discloses multiple pick-up electrodes (Paragraph [0102] - the primary 511… The primary electrode can also be one or more sensing electrodes), but fails to explicitly disclose at least 25 pick-up electrodes. Jersey-Willuhn et. al.'630 teaches utilizing 32 electrodes (Paragraph [0187] - Any number of electrodes may be used… a suitable sensor can use 32 or any other number of electrodes). 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 Anderson'561 in view of Gao et. al.'817, further in view of Ogata et. al.'547 to include at least 25 sensing electrodes as seen in Jersey-Willuhn et. al.'630. It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the number of sensing electrodes. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal number of sensing electrodes. "Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 15, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the method of Claim 14 above. Anderson'561 further discloses multiple pick-up electrodes (Paragraph [0102] - the primary 511… The primary electrode can also be one or more sensing electrodes), but fails to explicitly disclose at least 25 pick-up electrodes. Jersey-Willuhn et. al.'630 teaches at utilizing 32 electrodes (Paragraph [0187] - Any number of electrodes may be used… a suitable sensor can use 32 or any other number of electrodes). 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 Anderson'561 in view of Gao et. al.'817, further in view of Ogata et. al.'547 to include at least 25 sensing electrodes as seen in Jersey-Willuhn et. al.'630. It is noted that the applicant has failed to provide details of criticality or unexpected results in the specification with regard to the number of sensing electrodes. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine an optimal number of sensing electrodes. "Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson'561 (U.S. Patent Publication 20100168561 - previously cited), in view of Gao et. al.'817 (U.S. Patent Publication 20090325817 - previously cited), further in view of Ogata et. al.'547 (U.S. Patent Publication 20210251547), as applied to Claims 6 and 9 respectively above, and further in view of Egorov et. al.'777 (U.S. Patent 8016777 - previously cited).
Regarding Claim 7, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 6 above, 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. Egorov et. al.'777 teaches comparing force between an electrode array and a target location of a subject to optimal ranges (Paragraph [0010] - The transrectal probe of the invention is equipped with a pressure sensor array which is shaped and configured to fit into a rectum and acquire stress patterns of the prostate gland and surrounding tissues. Readings from the sensor array are continuously analyzed by the device and decisions are made as to whether the readings are likely to be that of a prostate or not. A test progression indicator is provided and configured to inform the operator whether the probe is positioned over the prostate properly and the data accumulated by pressing the probe against the prostate is of acceptable quality for further processing. Is the data is accepted by the device, a degree of completion information may also be communicated to the operator. Acceptance of the data is decided upon by the device using at least one of several data quality thresholds). 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 Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 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 Egorov et. al.'777.
Regarding Claim 20, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 9 above. Anderson'561 further discloses a pressure and stress sensor (Paragraph [0094] - This can be accomplished using a sensing element that is an accelerometer, pressure sensor, stress sensor, or optical sensor), but fails to disclose wherein the processor is further configured to compare the force with which the electrode array is pressed against the tissue against optimum force limits. Egorov et. al.'777 teaches comparing force between an electrode array and a target location of a subject to optimal ranges (Paragraph [0010] - The transrectal probe of the invention is equipped with a pressure sensor array which is shaped and configured to fit into a rectum and acquire stress patterns of the prostate gland and surrounding tissues. Readings from the sensor array are continuously analyzed by the device and decisions are made as to whether the readings are likely to be that of a prostate or not. A test progression indicator is provided and configured to inform the operator whether the probe is positioned over the prostate properly and the data accumulated by pressing the probe against the prostate is of acceptable quality for further processing. Is the data is accepted by the device, a degree of completion information may also be communicated to the operator. Acceptance of the data is decided upon by the device using at least one of several data quality thresholds). 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 Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 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 Egorov et. al.'777.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson'561 (U.S. Patent Publication 20100168561 - previously cited), in view of Gao et. al.'817 (U.S. Patent Publication 20090325817 - previously cited), further in view of Ogata et. al.'547 (U.S. Patent Publication 20210251547), further in view of Egorov et. al.'777 (U.S. Patent 8016777 - previously cited), as applied to Claim 7 above, and further in view of Aljuri et. al.'505 (U.S. Patent Publication 20190240505 - previously cited).
Regarding Claim 10, Anderson'561 in view of Gao et. al.'817, further in view of Ogata et. al.'547, and further in view of Egorov et. al.'777 discloses the apparatus of Claim 7 above. Anderson'561 further discloses the electronics module and electrode array form a probe configured to fit through a laparoscopic port (Paragraph [0059] - 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), but fails to disclose configured to fit through a twelve millimeter diameter laparoscopic port. Aljuri et. al.’505 teaches a probe with a diameter between one and ten millimeters ([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 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 twelve millimeter, 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 12 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson'561 (U.S. Patent Publication 20100168561 - previously cited), in view of Gao et. al.'817 (U.S. Patent Publication 20090325817 - previously cited), and further in view of Ogata et. al.'547 (U.S. Patent Publication 20210251547), as applied to Claim 9 above, and further in view of Aljuri et. al.'505 (U.S. Patent Publication 20190240505 - previously cited).
Regarding Claim 12, Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 discloses the apparatus of Claim 9 above, but fails to disclose there are eight driving electrodes and 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 Anderson'561 in view of Gao et. al.'817, and further in view of Ogata et. al.'547 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).
Response to Arguments
Applicant's arguments filed 03 June 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior claim objections.
Claims 1-20 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 3-7 above.
The examiner has considered the applicant’s arguments regarding their concern for the prior art of record Jersey-Willuhn et. al.’630 failing to disclose a device similar to that of the instant application. Without the examiner agreeing with or conceding to the concerns addressed by the applicant, the examiner has cited a new prior art of record, Anderson'561 (U.S. Patent Publication 20100168561 - previously cited), in Paragraphs 3-7 above based on the amendments submitted by the applicant. Anderson'561 discloses a bioimpedance measurement device configured to enter laparoscopic ports in a similar manner intended by the instant application. It is the understanding of the examiner that the sections of Anderson'561 cited above teach on each of the elements claimed within the instant application or can be modified by other prior art (as cited above) in obvious manners.
With that being said, the examiner has also considered the applicant’s argument pertaining to the prior art of record, Jersey-Willuhn et. al.’630, failing to disclose an “invasive” device capable of being able “to fit within a laparoscopic port”, but these arguments were found to be not persuasive. The examiner notes that Claim 1 of the instant application is a system claim. This means that the system would merely have to be capable of performing functions recited within the limitation. Therefore the examiner makes an additional note of the prior art of record Jersey-Willuhn et. al.’630 that discloses a probe of their device capable of being inserted into a patient’s vascular system (Paragraph [0049] - The conduit 112 comprises a flexible tubing 114 that couples to the infusion device 110 and a cannula 116, such as a needle or catheter, that is capable of inserting into the patient's vascular system). This discloses that the device of Jersey-Willuhn et. al.’630 was not limited to non-invasive applications.
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 SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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, 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
Prosecution Insights