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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 4th, 2026 has been entered.
Response to Amendment
The amendment filed February 4th, 2026 has been entered. Claims 1-20 remain pending in the application. Applicant’s amendments to the claims have overcome the objections and rejections previously set forth in the Final Office Action mailed September 23rd, 2025.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding applicant’s arguments about the rejection of claims 10-20 under 35 U.S.C. 101, the examiner respectfully disagrees. The amendment to claim 10 does not further incorporate a practical application into the claims. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the receiving, generating, and outputting steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Therefore claims 10-20 are not patent eligible. The examiner suggests incorporating a practical application into the claims (see for example applicant’s specification Paragraph [0050]).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 10-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claims 10-20 recite a process (methods).
Claim 10 recites:
A computer-implemented method for determining one or more tissue types at a location of a distal portion of a urethral catheter, the computer- implemented method comprising:
recording, at one or more frequencies, one or more impedance measurements (evaluation), using an impedance bridge coupled to two or more electrodes disposed on the distal portion of the urethral catheter;
comparing the two or more impedance measurements to two or more characteristic impedances (evaluation) associated with one or more tissue types;
and determining, based on the two or more impedance measurements and the two or more characteristic impedances, the one or more tissue types at the location associated with the distal portion (evaluation).
The limitation of recording data, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a computer-implemented method nothing in the claim element precludes the step from practically being performed in the mind. For example, “recording” in the context of this claim encompasses the user manually gathering data.
Similarly, the limitation of comparing the one or more impedance measurements, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, “comparing” in the context of this claim encompasses the user looking at the impedance values and comparing them to a chart of known impedance values to determine how similar or different they are. Further math calculations could be used for these comparisons.
Similarly, the limitation of determining one or more tissue types at a location associated with the distal portion, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. For example, “determining” in the context of this claim encompasses the user simply making a decision, based on the comparison of the impedance values to a chart or table, what type of tissue is in contact with the distal portion.
Claim 16 recites: The computer-implemented method of claim 10, further comprising measuring one or more dimensions of tissue (evaluation) residing at the location of the distal portion of the urethral catheter.
The limitation of measuring one or more dimensions of tissue, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a computer-implemented method nothing in the claim element precludes the step from practically being performed in the mind. For example, “measuring” in the context of this claim encompasses the user manually measuring the tissue dimensions and gathering data.
Claim 17 recites: The computer-implemented method of claim 10, further comprising outputting at least one of a visual indication or an audio indication (opinion) of the one or more tissue types at the location of the distal portion of the urethral catheter.
The limitation of outputting, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a computer-implemented method nothing in the claim element precludes the step from practically being performed in the mind. For example, “outputting” in the context of this claim encompasses the user calculating using a mental process or math, a result based on the data and showing it to the physician.
Claim 18 recites: The computer-implemented method of claim 10, further comprising determining a confidence score associated with the one or more tissue types (evaluation) at the location of the distal portion of the urethral catheter.
The limitation of determining a confidence score associated with the one or more tissue types, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a computer-implemented method nothing in the claim element precludes the step from practically being performed in the mind. For example, “determining” in the context of this claim encompasses the user calculating using a mental process or math, a confidence score based on the data.
Claim 19 recites: The computer-implemented method of claim 10, further comprising transmitting, via a wireless transmitter, a wireless signal indicating the one or more tissue types (opinion) at the location of the distal portion of the urethral catheter.
The limitation of transmitting a signal indicating the one or more tissue types, as drafted, is a process, that under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting a computer-implemented method nothing in the claim element precludes the step from practically being performed in the mind. For example, “transmitting” in the context of this claim encompasses the user calculating using a mental process or math, a result of what the tissue type is based on the data and showing it to the physician.
If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” and “Math” grouping of abstract ideas. Accordingly, the claims recite abstract ideas. See MPEP 2106.4(a).
This judicial exception is not integrated into a practical application. In particular, the claim only recites one additional element – using a computer to perform the steps of recording the impedance measurements, comparing the impedance measurements, determining the tissue type, measuring dimensions of the tissue, outputting a visual or audio indication, determining a confidence score, and transmitting the data regarding the tissue type. The computer in all three steps is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function of receiving data and generating an output based on a predicted level of success) such that it amount no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform the receiving, generating, and outputting steps amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Therefore claims 10-20 are not patent eligible. Dependent claims 11-20 fail to provide additional elements that are sufficient to amount to more than the judicial exception. Therefore dependent claims 11-20 are rejected for the same reasons as stated in the rejection for independent claim 10 from which they depend.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kasevich et al. (U.S. PGPub. No. 20060004301) herein referred to as “Kasevich” in view of Richardson et al. (U.S. PGPub. No. 20130123778) herein referred to as “Richardson”.
Regarding claim 1, Kasevich discloses a medical device, comprising:
a urethral catheter (the catheter would be inserted into the body and advanced to the desired area through an appropriate entry point such as the urethra (i.e., urethral catheter), Paragraph [0035]) including, a distal portion (distal portion is at the end of tube 11, Figure 3), and two or more electrodes disposed on the distal portion (two or more electrodes 13 and 17, Paragraph [0033], Figures 3 and 4); an impedance bridge coupled to the two or more electrodes (the present invention is a system and method for using electrical impedance tomography to characterize tissue in the human body, any such system requires at least two sets of electrodes, one of current injection electrodes and one of current return electrodes, voltages and currents may be applied to the electrode arrays, which creates a current from one to the other that runs through the intervening tissue, the system permits a measurement of the resistivity of the intervening tissue, which measurements are then used to create an image of the tissue which can be used to diagnose and/or treat disease or other conditions, Paragraph [0019]); wherein the two or more electrodes includes a first electrode and a second electrode that are adjacent to each other (two or more electrodes 13 and 17 are adjacent to each other in the center of the catheter, Figure 3) and a processor coupled to the impedance bridge (a generator, such as a computer running appropriate software, measures the resistivities of the targeted tissue 20 and creates an image of that tissue, Paragraph [0031]).
However Kasevich does not explicitly disclose wherein the processor is configured to (i) use the impedance bridge to measure two or more impedances, at respective two or more different frequencies, of tissue between the first electrode and the second electrode when the first electrode and second electrode are in contact with the tissue, and (ii) based on the two or more impedances, determining a tissue type of the tissue between the first electrode and the second electrode.
Richardson discloses wherein the processor is configured to (i) use the impedance bridge to measure two or more impedances, at respective two or more different frequencies, of tissue between the first electrode and the second electrode when the first electrode and second electrode are in contact with the tissue, and (ii) based on the two or more impedances, determining a tissue type of the tissue between the first electrode and the second electrode (the sensing electrodes 214, 216 may be used to monitor the impedance of the tissue separating them, various frequencies may be used to determine on or more impedance values, the impedance measurements may be used to determine which tissues are in the local ablation region, the use of various frequencies may allow for better discrimination between tissue types, Paragraph [0046]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich to incorporate the teachings of Richardson by including wherein the processor is configured to (i) use the impedance bridge to measure two or more impedances, at respective two or more different frequencies, of tissue between the first electrode and the second electrode when the first electrode and second electrode are in contact with the tissue, and (ii) based on the two or more impedances, determining a tissue type of the tissue between the first electrode and the second electrode. The motivation to do so being to use the impedance measurements to determine which tissues are in the location ablation region (Richardson, Paragraph [0046]).
Regarding claim 2, Kasevich in view of Richardson discloses the medical device of claim 1.
Kasevich further discloses wherein each of the two or more electrodes is located at a respective location along a length of the distal portion (electrode arrays 13 and 17 are located at respective locations along the length of the distal portion 12, Paragraph [0031]-[0032], Figures 3 and 4).
Regarding claim 3, Kasevich in view of Richardson discloses the medical device of claim 1.
Kasevich further discloses wherein at least one electrode of the two or more electrodes is located on a first side of the distal portion (electrode array 13 is located at the distal end of the distal portion 12, Figure 3), and at least another one electrode of the two or more electrodes is located on a second side of the distal portion (electrode array 17 is located at the proximal end of the distal portion 12, Figure 3).
Regarding claim 5, Kasevich in view of Richardson discloses the medical device of claim 1.
Kasevich discloses wherein the device further comprises a display coupled to the processor (The user then would use a current generator, such as a direct current generator or alternating current generator, which was attached to the electrodes to inject current into the targeted area, the user then would use an imaging device to calculate the resistivities of the tissues in the targeted area, and use algorithms to reconstruct the image of the targeted tissue and display or print it for the use of the user (seen as a display coupled to the processor)).
Regarding claim 7, Kasevich in view of Richardson discloses the medical device of claim 1.
Kasevich further discloses wherein the processor selectively couples the impedance bridge to at least two electrodes of the two or more electrodes (After expandable balloon 12 is inflated, a current generator, which is attached to the electrode arrays 13 and 17, is used to generate a current 30 that runs between the electrodes 13 and the electrodes 17 (seen as selectively coupling to at least two electrodes of the arrays of 13 and 17) and runs through the targeted tissue 20, Paragraph [0031]).
Regarding claim 8, Kasevich in view of Richardson discloses the medical device of claim 1.
Kasevich further discloses wherein the distal portion includes at least one of a balloon or a urinary cannula (distal portion is an expandable balloon 12, Paragraph [0021], Figure 3).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kasevich in view of Richardson further in view of Prakash et al. (U.S. PGPub. No. 20200237435) herein referred to as “Prakash”.
Regarding claim 4, Kasevich in view of Richardson discloses the medical device of claim 1.
However Kasevich in view of Richardson does not explicitly disclose wherein the device comprises an activation button coupled to the processor.
Prakash discloses a method for identifying and treating tissue includes providing an electrosurgical treatment device including an electrode assembly wherein one or more electrical property values of target tissue are measured (Abstract). Prakash further discloses wherein the device comprises an activation button coupled to the processor (processing unit 20 may be configured to continuously produce a signal, or instead bipolar forceps 100 may include a button or lever 122, 124 mounted on housing 120 (FIG. 1A) and/or processing unit 20 (FIG. 2) for activating processing unit 20, Paragraph [0052]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich in view of Richardson to incorporate the teachings of Prakash by including wherein the device comprises an activation button coupled to the processor. The motivation to do so being to selectively activate the processing unit (Prakash, Paragraph [0052]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kasevich in view of Richardson further in view of Stone et al. (U.S. PGPub. No. 20080125772) herein referred to as “Stone”.
Regarding claim 6, Kasevich in view of Richardson discloses the medical device of claim 1.
However Kasevich in view of Richardson does not explicitly disclose wherein the device further comprises a wireless transmitter coupled to the processor.
Stone discloses an atherosclerotic material detector system may measure and/or characterize the atherosclerotic material and its location, optionally using impedance monitoring (Abstract). Stone further discloses wherein the device further comprises a wireless transmitter coupled to the processor (the code and/or associated data and signals may also be transmitted to and/or from the processor via a network connection (such as a wireless network, Paragraph [0102]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich in view of Richardson to incorporate the teachings of Stone by including wherein the device further comprises a wireless transmitter coupled to the processor. The motivation to do so being to transfer code and/or data and signals to and from the processor (Stone, Paragraph [0102]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kasevich in view of Richardson further in view of Sharma et al. (U.S. PGPub. No. 20150126990) herein referred to as “Sharma”.
Regarding claim 9, Kasevich in view of Richardson discloses the medical device of claim 1.
However Kasevich in view of Richardson does not explicitly disclose wherein one or more insertion depth markings are disposed along a length of the urethral catheter.
Sharma discloses an ablation catheter (Abstract) wherein one or more insertion depth markings are disposed along a length of the urethral catheter (catheter inserted into urethra, Paragraph [0068], the depth of insertion is measured using the measurement markers on the internal catheter at step 708, Paragraph [0418]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich in view of Richardson to incorporate the teachings of Sharma by including wherein one or more insertion depth markings are disposed along a length of the urethral catheter. The motivation to do so being to measure the insertion depth of the catheter within the body (Sharma, Paragraph [0418]).
Claims 10-11, 13-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Kasevich in view of Richardson further in view of Shen et al. (U.S. PGPub. No. 20200253504) herein referred to as “Shen”.
Regarding claim 10, Kasevich discloses a computer-implemented method for determining one or more tissue types at a location associated with a distal portion of a urethral catheter, the computer- implemented method comprising:
recording, one or more impedance measurements, wherein each impedance measurement is associated with an impedance bridge coupled to two or more electrodes disposed on the distal portion of the urethral catheter (the present invention is a system and method for using electrical impedance tomography to characterize tissue in the human body, any such system requires at least two sets of electrodes, one of current injection electrodes and one of current return electrodes, voltages and currents may be applied to the electrode arrays, which creates a current from one to the other that runs through the intervening tissue, the system permits a measurement of the resistivity of the intervening tissue, which measurements are then used to create an image of the tissue which can be used to diagnose and/or treat disease or other conditions, Paragraph [0019]).
However Kasevich does not explicitly disclose recording, at two or more frequencies, respective two or more impedance measurements.
Richardson discloses wherein the processor is configured to record, at two or more frequencies, respective two or more impedance measurements (the sensing electrodes 214, 216 may be used to monitor the impedance of the tissue separating them, various frequencies may be used to determine on or more impedance values, the impedance measurements may be used to determine which tissues are in the local ablation region, the use of various frequencies may allow for better discrimination between tissue types, Paragraph [0046]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich to incorporate the teachings of Richardson by including wherein the processor is configured to record, at two or more frequencies, respective two or more impedance measurements. The motivation to do so being to use the impedance measurements to determine which tissues are in the location ablation region (Richardson, Paragraph [0046]).
Further, Kasevich does not explicitly disclose wherein the computer-implemented method comprises comparing the two or more impedance measurements to two or more characteristic impedances associated with one or more tissue types; and determining, based on the two or more impedance measurements and the two or more characteristic impedances, the one or more tissue types at the location of the distal portion of the urethral catheter.
Shen discloses a system for characterizing tissue (Abstract). Shen further discloses wherein the method comprises wherein the computer-implemented method comprises comparing the two or more impedance measurements to two or more characteristic impedances associated with one or more tissue types; and determining, based on the two or more impedance measurements and the two or more characteristic impedances, the one or more tissue types at the location of the distal portion of the urethral catheter (probe electrodes 151 can be selected to provide recorded signals 402 representing localized tissue characterization, and can vary depending on the type of tissue being characterized, Paragraph [0092], these recorded signal 402 properties are dependent upon the reflective, absorptive, conductive, reactive, and/or transmissive properties of the neighboring tissue, and thus can be used to characterize the neighboring tissue (e.g. when compared to similar data for known tissue types), a feedback indicator or other user interface can be included to provide information about the determined tissue characteristics of the neighboring tissue (e.g. tissue at the tip of the probe) to an operator of the system (e.g. a surgeon or other clinician), such as for use in making decisions during the performance of the clinical procedure, Paragraph [0083], The signal resulting from transmission of the drive signals 401 through neighboring tissue can be measured in terms of a state and/or change (relative change) in one or more of voltage, power, energy, current, phase and/or frequency, system 10 and controller 220 can use one or more of these measurements, and/or a calculated quantity such as electrical impedance or resistance of the tissue to produce TCI 400, Paragraph [0195]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich to incorporate the teachings of Shen by including wherein the method comprises wherein the computer-implemented method comprises comparing the two or more impedance measurements to two or more characteristic impedances associated with one or more tissue types; and determining, based on the two or more impedance measurements and the two or more characteristic impedances, the one or more tissue types at the location of the distal portion of the urethral catheter. The motivation to do so being to allow for the surgeon or clinician to make safer and faster decisions about how to treat the tissue during the procedure (Shen, Paragraph [0195]).
Regarding claim 11, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 10.
However Kasevich in view of Richardson does not explicitly disclose wherein the one or more tissue types include at least one of a cancer tissue type, a non-cancer tissue type, a prostate tissue type, or a non-prostate tissue type.
Shen discloses wherein the one or more tissue types include at least one of a cancer tissue type, a non-cancer tissue type, a prostate tissue type, or a non-prostate tissue type (determination of the of tumor versus normal, healthy tissues, as well as the margins of tumor tissue, all using system 10, will allow an operator to improve both accuracy of treatment (e.g. correlating to improved outcomes), and speed of surgery, Paragraph [0163]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich in view of Richardson to incorporate the teachings of Shen by including wherein the method comprises comparing the one or more impedance measurements to one or more characteristic impedances associated with one or more tissue types; and determining, based on the one or more impedance measurements and the one or more characteristic impedances, one or more tissue types at a location associated with the distal portion. The motivation to do so being to allow an operator to improve both accuracy of treatment (e.g. correlating to improved outcomes), and speed of surgery (Shen, Paragraph [0163]).
Regarding claim 13, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 10.
Kasevich further discloses wherein the two or more impedance measurements include a first impedance measurement made using a first subset of the two or more electrodes (first subset of the two or more electrodes, see modified Figure 3 below), and a second impedance measurement made using a second subset of the two or more electrodes (second subset of the two or more electrodes, see modified Figure 3 below).
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Regarding claim 14, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 13.
Kasevich further discloses wherein the first subset of the two or more electrodes is located at a first location along the distal portion of the urethral catheter (first subset is associated with a center location along the distal portion, see modified Figure 3), and the second subset of the two or more electrodes is located at a second location along the distal portion of the urethral catheter (second subset is associated with a second location around the center location along the distal portion, see modified Figure 3).
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Regarding claim 15, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 13.
Kasevich further discloses wherein the first subset of the two or more electrodes is located on a first side of the distal portion of the urethral catheter (see modified Figure 3), and the second subset of the two or more electrodes is located on a second side of the distal portion of the urethral catheter(see modified Figure 3).
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Regarding claim 16, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 10.
However Kasevich in view of Richardson does not explicitly disclose wherein the computer-implemented method further comprises measuring one or more dimensions of tissue residing at the location of the distal portion of the urethral catheter.
Shen discloses wherein the computer-implemented method further comprises measuring one or more dimensions of tissue residing at the location of the distal portion of the urethral catheter (Determination of the of tumor versus normal, healthy tissues, as well as the margins of tumor tissue (seen as measuring a dimension of the tissue, i.e., the size, or where the tumor tissue starts and ends), all using system 10, will allow an operator to improve both accuracy of treatment (e.g. correlating to improved outcomes), and speed of surgery, Paragraph [0163]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich in view of Richardson to incorporate the teachings of Shen by including wherein the computer-implemented method further comprises measuring one or more dimensions of tissue residing at the location of the distal portion of the urethral catheter. The motivation to do so being to allow an operator to improve both accuracy of treatment (e.g. correlating to improved outcomes), and speed of surgery (Shen, Paragraph [0163]).
Regarding claim 17, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 10.
However Kasevich does not explicitly disclose wherein the computer-implemented method further comprises outputting at least one of a visual indication or an audio indication of the one or more tissue types at the location of the distal portion of the urethral catheter.
Shen discloses wherein the computer-implemented method further comprises outputting at least one of a visual indication or an audio indication of the one or more tissue types at the location of the distal portion of the urethral catheter (system 10 can be configured to trigger an output signal to the operator under certain conditions, the output signal provided by user interface 250 and including: an audible signal; a visible signal such as a displayed icon or a light (e.g. a flashing light); a sensory notification, such as a vibration; a text or numerical value related to tissue in proximity to probe electrodes 151 (e.g. a value related to the distance to the tissue; a value representative of the tissue type; and/or a value related to the tissue characteristics), user interface 250 can display numerical values, text, and/or graphical representations (e.g. icons, charts, and/or figures), which can be interpreted by the operator of system 10, the output provided by user interface 250 can specifically identify types of tissue and/or provide other TCI 400, Paragraph [0192]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich in view of Richardson to incorporate the teachings of Shen by including wherein the computer-implemented method further comprises outputting at least one of a visual indication or an audio indication of the one or more tissue types at the location of the distal portion of the urethral catheter. The motivation to do so being to provide information regarding the tissue type and other information related to a change in tissue type, a change in a tissue characteristic, and/or another change, such as to alert the operator that one or more tissue characteristics are changing (Shen, Paragraph [0192]).
Regarding claim 18, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 10.
However Kasevich in view of Richardson does not explicitly disclose wherein the computer-implemented method comprises determining a confidence score associated with the one or more tissue types at the location of the distal portion of the urethral catheter.
Shen further discloses wherein the computer-implemented method comprises determining a confidence score associated with the one or more tissue types at the location of the distal portion of the urethral catheter (system 10 can primarily use one tissue model to make a prediction (for example, the tissue model with the highest validation score (seen as a confidence score) and additionally use other tissue models to compare the predicted tissue probabilities output of the primary tissue model, for example as a safety check or other confirmatory step, Paragraph [0130]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich to incorporate the teachings of Shen by including wherein the computer-implemented method comprises determining a confidence score associated with the one or more tissue types at the location of the distal portion of the urethral catheter. The motivation to do so being to ensure the system is detecting the correct tissue type based on the measurements and data provided to train the system (Shen, Paragraphs [0129] and [0130]).
Regarding claim 20, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 10.
Kasevich further discloses wherein the computer-implemented method comprises causing a balloon included in the distal portion of the urethral catheter to inflate (the expandable balloon 12 is removably attached to flexible tube 11 (i.e., urethral catheter), which is used to insert the balloon and electrode array inside the body in proximity to the targeted tissue 20, after expandable balloon 12 is inflated, a current generator, which is attached to the electrode arrays 13 and 17, is used to generate a current 30 that runs between the electrodes 13 and the electrodes 17 and runs through the targeted tissue 20, Paragraph [0031]).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Kasevich in view of Richardson and Shen further in view of Prakash.
Regarding claim 12, Kasevich in view of Shen discloses the computer-implemented method of claim 10.
However Kasevich in view of Richardson and Shen does not explicitly disclose wherein the one or more impedance measurements are recorded in response to an activation associated with an activation button.
Prakash further discloses wherein the two or more impedance measurements are recorded in response to an activation associated with an activation button (processing unit 20 may be configured to continuously produce a signal, or instead bipolar forceps 100 may include a button or lever 122, 124 mounted on housing 120 (FIG. 1A) and/or processing unit 20 (FIG. 2) for activating processing unit 20, Paragraph [0052], these portions of tissue produce characteristic tissue responses based on the signals delivered to electrodes 51, 52, 53, 54 by processing unit 20, the resulting tissue response is acquired by inner electrodes 52, 53, as discussed above, the measurements of the tissue response may be used to calculate the tissue impedance (seen as activating the processing unit to provide the energy which in turn also activates the impedance recording function), Paragraph [0052]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich in view of Richardson and Shen to incorporate the teachings of Prakash by including wherein the device comprises an activation button coupled to the processor. The motivation to do so being to selectively activate the processing unit (Prakash, Paragraph [0052]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Kasevich in view of Richardson and Shen further in view of Stone.
Regarding claim 19, Kasevich in view of Richardson and Shen discloses the computer-implemented method of claim 10.
However Kasevich in view of Richardson and Shen does not explicitly disclose wherein the computer implemented method further comprises transmitting, via a wireless transmitter, a wireless signal indicating the one or more tissue types at the location of the distal portion of the urethral catheter.
Stone further discloses wherein the device further comprises a wireless transmitter coupled to the processor (the code and/or associated data and signals may also be transmitted to and/or from the processor via a network connection (such as a wireless network, Paragraph [0102], impedance data, Paragraph [0144]).
It would have been prima facie obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to have modified Kasevich to incorporate the teachings of Stone by including wherein the device further comprises a wireless transmitter coupled to the processor. The motivation to do so being to transfer code and/or data and signals to and from the processor (Stone, Paragraph [0102]).
Conclusion
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/D.S./Examiner, Art Unit 3794 /JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794