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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/20/2026 has been entered.
Response to Amendment
The amendment filed 02/20/2026 has been entered. Claims 1-10 & 12-16 remain pending in the application.
Response to Arguments
Applicant's arguments with respect to claims 1-10 & 12-16 have been considered but are not seen as persuasive, see reasoning below.
Regarding claim 1, applicant argues Chou does not explicitly disclose “one or more electrical emitters mounted on the intracardiac device and configures to emit an impulse of electrical energy into a first portion of a tissue within a patient heart”. While examiner acknowledges the Wikipedia definitions. Examiner still stands by the rejection, such that, Chou disclosed transducers 12b emit an ultrasound signal and receive ultra sound reflection to determine a point on the surface of a heart chamber which is disclosed in Paragraph [0112]. An ultrasound signal functions by converting electrical energy into mechanical/acoustic energy to transmit a signal and then back into electrical energy when receiving the mechanical/acoustic energy. This is a known phenomena in the art. Therefore, this electrical energy is still being emitted but is also being converted into mechanical/acoustic energy. Such that with the definition provided for electrical energy from Wikipedia, “electrical energy is the energy transferred as electric charges move between points with different electric potential”, the electric energy from the transmitter is transmitted as mechanical/acoustic energy and when received by a receiver is converted back into electrical energy, therefore still reads on the definition of taught by Wikipedia. Applicant also argues that Chou does not explicitly disclose wherein the device can detect different tissues based on difference between the emitted and received electrical pulses. Examiner disagrees, as disclosed above, the ultrasound signal functions by converting electrical energy into mechanical/acoustic energy to transmit a signal and then back into electrical energy when receiving the mechanical/acoustic energy, therefore, the signal is converted back into electrical energy when received by the electrode to record, measure and/or sense a bio-potential such as a voltage level. It would also be obvious to one of the ordinary skill in the art that if the transducers and electrodes are in communication (e.g. receiving and sending signals) that there would have to be a conversion of sorts for them to be able to receive and send signals on the same medium. In regards to the determining an impedance of the tissue, the LOC module can be impedance based, such that the impedance of the tissue has to be determined to be able to use it to calculate in the LOC. While it is stated the LOC can utilize ultrasound, RF, and/or fluoroscopy, as taught above ultrasound is still electrical energy. With that being saif RF also consist of electrical energy such that RF energy is electromagnetic wave such that it is alternating electric current or voltage. Applicant also argues that Chou does not disclose “comparing a voltage of the input pulse with a voltage of the corresponding pulse.” Examiner disagrees, in paragraph [0190] of Chou it is stated “mapping data 110 comprises both dipole density data calculated from non-contact recordings and voltage measurements recorded from contact recordings (e.g. from electrodes in contact with the cardiac wall)… and compare the calculated dipole density data to the voltage measurements,” such that the calculated dipole density data is the input pulse, which as taught above is from the transmitters and the voltage measurements are the corresponding pulse received by the electrodes. In regards to the LOC module, as taught above, it is one method of finding impedance such that the processor shown in figure 1, takes the data from all different aspects of the device to process it. In paragraph [0088] of Chou it is stated that processing algorithm 551 can analyze mapping data 110 and classify portions of the tissue based on electrical impedance, therefore the mapping data as well is able to determine impedance based on the data as well. Therefore, Examiner stands by the rejection of claim 1 as taught above and in the reasonings in the final rejection.
Regarding claim 5 & 14, applicant argues that none of the reference suggest placing emitters and detectors on an intracardiac device, emitting an electrical pulse from the emitters and detecting that pulse using detectors and the change of impedance indicating the tissue type. While neither claim 5 or 14 claim any of this, Examiner assumes the arguments are in regards to the subject matter of claim 1 which is argued above.
Regarding claims 9 & 16, applicant argues Ruben does not explicitly disclose an intracardiac blood pump. Examiner agrees, such that Ruben in Column 12, lines 56-64 and Column 13, lines 9-20 it is disclosed a blood pump not an intracardiac blood pump. Based on applicants’ arguments, Examiner provided new rejections for these claims below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1-4, 6-8, 10-13 & 15 are rejected under 35 U.S.C 102(a)(2) as being anticipated by CHOU et al. (US 20210169394) herein referred to as CHOU.
Regarding claim 1, CHOU discloses a system for sensing tissue characteristics (Figure 1, 1000), comprising: an intracardiac device configured to be inserted into a patient's heart (Figure 1, 10; Paragraph [0068]; wherein the intracardiac device is inserted into a patient to record cardiac activity therefore is inserted within the heart); one or more electrical emitters mounted on the intracardiac device (Figure 2, 12b) and configured to emit an input pulse of electrical energy into a first portion of a tissue within the patient's heart (Paragraph [0112]; wherein transducers 12b emit an ultrasound signal and receive ultra sound reflection to determine a point on the surface of a heart chamber therefore electrical energy is being emitted into a first portion of a tissue within the patient’s heart); one or more electrical sensors mounted on the intracardiac device and configured to sense a corresponding pulse of electrical energy at a second portion of the tissue within the patient's heart (Figure 2, 12a), the corresponding pulse of electrical energy resulting from the conduction of the input pulse through the tissue (Paragraph [0102]; wherein electrode 12a can be configured to record, measure and/or sense a bio-potential such as a voltage level at a location on or within the heart chamber); and one or more processors (Figure 1, 120 & 550) configured to: compare a voltage of the input pulse with a voltage of the corresponding pulse (Paragraph [0069]; wherein the dipole density data is calculated from the voltage recordings of the input pulse; Paragraph [0190]; wherein data processing algorithm 120 & 551 is configured to compare the calculated dipole density data to the voltage measurements of the corresponding pulse from the electrode); determine an impedance value of the tissue based on the comparison (Paragraph [0080]; wherein LOC module is impedance based therefore the impedance value is being determined based on the comparison); and determine a tissue type of the tissue based at least in part on the impedance value (Paragraph [0088]; wherein tissue types can be classified as healthy tissue, fibrotic tissue, scar tissue or any other indicators of condition of the particular tissue and evaluation data can include classifying a tissue characteristic by electrical impedance value).
Regarding claim 2, CHOU discloses the system of claim 1, wherein the one or more electrical emitters comprises a first emitter mounted at a first location on the intracardiac device (Figure 2, 12b; wherein there are multiple emitters mounted on the intracardiac device therefore for example, transducer 12b is seen as first location), and the one or more electrical sensors comprises a first sensor mounted at a second location on the intracardiac device (Figure 2, 12a; wherein there are multiple electrical sensors mounted on the intracardiac device therefore for example, transducer 12a is seen as first location).
Regarding claim 3, CHOU discloses the system of claim 3, wherein the first sensor is further configured to emit pulses of electrical energy (Paragraph [0138]; wherein bio-potential processor processes the bio-potentials from the electrodes therefore, they are emitting a pulse of electrical energy to the bio-potential processor), and the first emitter is further configured to sense pulses of electrical energy (Paragraph [0141]; wherein transducer can be put into receiver mode to receive ultrasound signals therefore being capable of sensing pulses of electrical energy wherein the ultrasound signals are pulses of electrical energy).
Regarding claim 4, CHOU discloses the system of claim 1, wherein the one or more processors being configured to determine a tissue type of the tissue based at least in part on the impedance value comprises being configured to compare the impedance value to a reference impedance value (Paragraph [0088]; wherein evaluation data can include classifying portions of tissue based on electrical impedance therefore there would have to be a reference impedance value for each classification of tissue to be able to accurately classify tissue).
Regarding claim 6, CHOU discloses the system of claim 1, further comprising: a controller configured to cause the one or more electrical emitters to emit the input pulse (Figure 2, 20; Paragraph [0130]; wherein US isolation MUX of controller 20 can turn on/off transducers as well as multiplexes one transmit/receive circuit to one or multiple transducers therefore acting as a controller to cause the electrical emitters to emit a pulse)
Regarding claim 7, CHOU discloses the system of claim 1, wherein the controller is further configured to receive the corresponding pulse from the one or more electrical sensors (Figure 2, 36; Paragraph [0138]; wherein bio-processor 36 receives the corresponding pulse from electrode 12a for processing).
Regarding claim 8, CHOU discloses the system of claim 7, wherein the controller comprises the one or more processors (Figure 1, 20; wherein controller 20 contains data processing algorithm 120)
Regarding claim 10, CHOU discloses a method for sensing tissue characteristics (Paragraph [0034]; wherein the method is the algorithm used in the system to sense tissue characteristics and predict them), comprising: inserting an intracardiac device into a patient's heart (Figure 1, 10; Paragraph [0068]; wherein the intracardiac device is inserted into a patient to record cardiac activity therefore can be inserted within the heart), the intracardiac device having one or more electrical emitters and one or more electrical sensors (Figure 2, 12a & 12b; wherein the electrodes 12a act as electrical sensors and the transducers 12b act as electrical emitters); emitting an input pulse of electrical energy into a first portion of a tissue within the patient's heart using the one or more electrical emitters (Paragraph [0112]; wherein transducers 12b emit an ultrasound signal and receive ultra sound reflection to determine a point on the surface of a heart chamber therefore electrical energy is being emitted into a first portion of a tissue within the patient’s heart); sensing a corresponding pulse of electrical energy at a second portion of the tissue within the patient's heart using the one or more electrical sensors (Paragraph [0102]; wherein electrode 12a can be configured to record, measure and/or sense a bio-potential such as a voltage level at a location on or within the heart chamber), the corresponding pulse of electrical energy resulting from the conduction of the input pulse through the tissue (Paragraph [0102]; wherein electrode 12a can be configured to record, measure and/or sense a bio-potential such as a voltage level at a location on or within the heart chamber); comparing, using one or more processors of a processing system (Figure 1, 120 & 550), a voltage of the input pulse from one or more electrical emitters with a voltage of the corresponding pulse sensed by the one or more electrical sensors (Paragraph [0069]; wherein the dipole density data is calculated from the voltage recordings of the input pulse such that the input pulse can be from the emitter as taught in Paragraph [0071]; wherein the system can be configured to operate in a pulse-echo mode where the transmitting elements, are located in a location different than the receiving elements for a given transmission event. ; Paragraph [0190]; wherein data processing algorithm 120 & 551 is configured to compare the calculated dipole density data to the voltage measurements of the corresponding pulse from the electrode); determining, using the one or more processors, an impedance value of the tissue based on the comparison (Paragraph [0080]; wherein LOC module is impedance based therefore the impedance value is being determined based on the comparison); and determining, using the one or more processors, a tissue type of the tissue based at least in part on the impedance value (Paragraph [0088]; wherein tissue types can be classified as healthy tissue, fibrotic tissue, scar tissue or any other indicators of condition of the particular tissue and evaluation data can include classifying a tissue characteristic by electrical impedance value); wherein the one or more electrical emitters comprises a first emitter mounted at a first location on the intracardiac device (Figure 2, 12b; wherein there are multiple emitters mounted on the intracardiac device therefore for example, transducer 12b is seen as first location), and the one or more electrical sensors comprises a first sensor mounted at a second location on the intracardiac device (Figure 2, 12a; wherein there are multiple electrical sensors mounted on the intracardiac device therefore for example, transducer 12a is seen as first location).
Regarding claim 12, CHOU discloses the method of claim 10, wherein the first sensor is further configured to emit pulses of electrical energy (Paragraph [0138]; wherein bio-potential processor processes the bio-potentials from the electrodes therefore, they are emitting a pulse of electrical energy to the bio-potential processor), and the first emitter is further configured to sense pulses of electrical energy (Paragraph [0141]; wherein transducer can be put into receiver mode therefore receiving/sensing pulses of electrical energy).
Regarding claim 13, CHOU discloses the method of claim 10, wherein determining a tissue type of the tissue based at least in part on the impedance value comprises comparing the impedance value to a reference impedance value (Paragraph [0088]; wherein evaluation data can include classifying portions of tissue based on electrical impedance therefore there would have to be a reference impedance value for each classification of tissue to be able to accurately classify tissue).
Regarding claim 15, CHOU discloses the method of claim 13, wherein the reference impedance value is generated by (Figure 1, 520; Paragraph [0096]; wherein training data is the reference data collected from the system in the same manner that evaluation data is collected): emitting an input pulse of electrical energy into a first portion of a reference tissue within the patient's heart using the one or more electrical emitters (Paragraph [0112]; wherein transducers 12b emit an ultrasound signal and receive ultra sound reflection to determine a point on the surface of a heart chamber therefore electrical energy is being emitted into a first portion of a tissue within the patient’s heart); sensing a corresponding pulse of electrical energy at a second portion of the reference tissue within the patient's heart using the one or more electrical sensors (Paragraph [0102]; wherein electrode 12a can be configured to record, measure and/or sense a bio-potential such as a voltage level at a location on or within the heart chamber), the corresponding pulse of electrical energy resulting from the conduction of the input pulse through the reference tissue (Paragraph [0102]; wherein electrode 12a can be configured to record, measure and/or sense a bio-potential such as a voltage level at a location on or within the heart chamber); comparing, using the one or more processors (Figure 1, 120 & 550), a voltage of the input pulse with a voltage of the corresponding pulse (Paragraph [0069]; wherein the dipole density data is calculated from the voltage recordings of the input pulse; Paragraph [0190]; wherein data processing algorithm 120 & 551 is configured to compare the calculated dipole density data to the voltage measurements of the corresponding pulse from the electrode); and determining, using the one or more processors, the reference impedance value of the tissue based on the comparison (Paragraph [0088]; wherein tissue types can be classified as healthy tissue, fibrotic tissue, scar tissue or any other indicators of condition of the particular tissue and evaluation data can include classifying a tissue characteristic by electrical impedance value).
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 5 & 14 are rejected under 35 U.S.C 103 as being unpatentable over CHOU in view of Grinberg et al. (US 20210077022) herein referred to as Grinberg.
Regarding Claim 5, CHOU discloses the system of claim 4 wherein one or more processors compare impedance values to determine a tissue type (Paragraph [0088]; wherein evaluation data can include classifying portions of tissue based on electrical impedance wherein it is obvious that to classify the tissue, there would have to be some sort of comparison of impedance values to properly classify the tissue). However, CHOU does not explicitly disclose wherein the one or more processors being configured to compare the impedance value to a reference impedance value further comprises being configured to determine whether the impedance value differs from the reference impedance value by a predetermined amount or percentage.
Grinberg discloses an intracardiac device (Figure 1, 100) wherein the one or more processors being configured to compare the impedance value to a reference impedance value further comprises being configured to determine whether the impedance value differs from the reference impedance value by a predetermined amount or percentage (Paragraph [0133]-[0134]; wherein a processor compares a reference impedance to a impedance value being measure to see if there is a 10% increase in impedance). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor taught by CHOU to include the teachings of the processor taught by Grinberg. The motivation being to allow for confirmation that the device is in an acceptable position before moving forward (Grinberg, Paragraph [0133]).
Regarding Claim 14, CHOU discloses the method of claim 13. However, CHOU does not explicitly disclose wherein comparing the impedance value to a reference impedance value further comprises determining whether the impedance value differs from the reference impedance value by a predetermined amount or percentage.
Grinberg discloses an intracardiac device (Figure 1, 100) wherein the one or more processors being configured to compare the impedance value to a reference impedance value further comprises being configured to determine whether the impedance value differs from the reference impedance value by a predetermined amount or percentage (Paragraph [0133]-[0134]; wherein a processor compares a reference impedance to a impedance value being measure to see if there is a 10% increase in impedance). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor taught by CHOU to include the teachings of the processor taught by Grinberg. The motivation being to allow for confirmation that the device is in an acceptable position before moving forward (Grinberg, Paragraph [0133]).
Claims 9 & 16 are rejected under 35 U.S.C 103 as being unpatentable over CHOU in view of Siess et al. (US 20080086027) herein referred to as Siess.
Regarding Claim 9, CHOU discloses the system of claim 1. However, CHOU does not explicitly disclose wherein the intracardiac device comprises an intracardiac blood pump.
Siess discloses an intracardiac device (Figure 1) comprising an intracardiac blood pump (Figure 1, 11). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by CHOU to comprises an intracardiac blood pump as taught by Siess. The motivation being to deliver blood from the heart into an artery (Siess, Paragraph [0002]).
Regarding Claim 16, CHOU discloses the method of claim 10. However, CHOU does not explicitly disclose wherein the intracardiac device comprises an intracardiac blood pump.
Siess discloses an intracardiac device (Figure 1) comprising an intracardiac blood pump (Figure 1, 11). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the device taught by CHOU to comprises an intracardiac blood pump as taught by Siess. The motivation being to deliver blood from the heart into an artery (Siess, Paragraph [0002]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M PAPE whose telephone number is (703)756-5947. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 303-297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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