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 .
Election/Restriction
Applicant’s election without traverse of Group I (claims 1-10) in the reply filed on 5/26/2026 is acknowledged.
Claims 11-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/26/2026.
Claim Objections
Claim 7 is objected to because of the following informalities: line 1: “according to aclaim 1” should be “according to claim 1”. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-2, 7 are rejected under 35 U.S.C. 103 as being unpatentable over US 4920954 Alliger et al. (hereinafter Alliger) in view of US 20050049475 Gregersen.
Regarding claim 1, Alliger discloses an ultrasonic catheter system (10, Fig. 1, abstract), comprising:
an ultrasonic transducer (19, Fig. 4) configured to deliver ultrasonic vibrational energy when activated (abstract, col. 7 line 1-6); and
an ultrasonic catheter (17, Fig. 1-2, 4-5) coupled to the ultrasonic transducer to receive the ultrasonic vibrational energy (col. 6 line 63-65, Fig. 1-2, 4-5), the ultrasonic catheter including an elongate flexible catheter sheath (as seen in Fig. 1-2, catheter 17 has a flexible outer sheath surrounding wire 16) and a distal end portion having a longitudinal axis (distal portion of catheter 17 as seen in Fig. 1-2, 4-5), the distal end portion including a distal tip element (48, Fig. 1, 4-5).
Alliger is silent on the distal end portion including a longitudinal pressure sensor and the longitudinal pressure sensor configured to generate a catheter longitudinal pressure signal corresponding to a sensed longitudinal pressure encountered by the ultrasonic catheter along the longitudinal axis of the distal end portion.
However, Gregersen teaches an apparatus for measuring physical reactions in a body (abstract, paragraph 1) that comprises a catheter (1, Fig. 1-2) with a distal end portion (3) having pressure sensors (strain gauges 9, Fig. 2, paragraph 25, 30, 45) that are configured to sense a longitudinal pressure exerted on the catheter along a longitudinal axis of the catheter and produce a pressure signal (paragraph 25, 30, 45).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Alliger with the teachings of Gregersen in order to measure the degree of longitudinal pressure applied to the catheter.
Regarding claim 2, the combination of Alliger and Gregersen teaches the limitations of claim 1, and the combination further discloses wherein the elongate flexible catheter sheath is proximal to the distal tip element (as seen in Fig. 1, 4-5), and wherein the longitudinal pressure sensor is configured to longitudinally extend between the elongate flexible catheter sheath and the distal tip element (Gregersen: as seen in Fig. 1-2, paragraph 45, the longitudinal pressure sensors 9 are placed between a proximal end 2 and a distal end 3 of the catheter 1, and the catheter 1 is inferred to have a flexible catheter sheath in order to flex within the body as seen in Fig. 1).
Regarding claim 7, the combination of Alliger and Gregersen teaches the limitations of claim 1, and Alliger further discloses comprising a handpiece (18, Fig. 1, 4) that contains the ultrasonic transducer (col. 4 line 47-51, col. 7 line 1-6), and wherein the elongate flexible catheter sheath of the ultrasonic catheter is coupled to the handpiece (as seen in Fig. 1, 4).
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Alliger in view of Gregersen as applied to claim 1 above, and further in view of US 4722348 Ligtenberg et al. (hereinafter Ligtenberg) and further in view of US 20120232549 Willyard et al. (hereinafter Willyard).
Regarding claim 3, the combination of Alliger and Gregersen teaches the limitations of claim 1, and Alliger further discloses further comprising a control circuit (Alliger: 22, Fig. 1, 4) electrically coupled to the ultrasonic transducer (Alliger: col. 8 line 58 – col. 9 line 9)
The combination is silent on the control circuit electrically coupled to the longitudinal pressure sensor, and the control circuit configured to activate the ultrasonic transducer when the sensed longitudinal pressure from the longitudinal pressure sensor of the ultrasonic catheter is equal to or greater than a threshold longitudinal resistance pressure.
However, Ligtenberg teaches a device for measuring pressure within a patient body (abstract, col. 1 line 5-17) having a pressure transducer (12, Fig. 1-2) that is electrically coupled to a control circuit (18) (col. 3 line 4-25, line 44 – col. 4 line 42, Fig. 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Alliger with Gregersen with the teachings of Ligtenberg in order to control and measure the electrical signal output from the pressure sensor.
Furthermore, Willyard teaches an electrosurgical system having an electrosurgical probe (abstract) wherein a control circuit (processor unit 82, Fig. 1) receives pressure level data from a pressure transducer (70) and in response to the pressure level below a predetermined threshold will stop energy delivery between an electrosurgical power generating source (28) to the probe (100) and in response to the pressure level above the predetermined threshold will enable energy delivery between the electrosurgical power generating source (28) to the probe (100) (paragraph 51-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the modification of Alliger with Gregerson and Ligtenberg with the teachings of Willyard to ensure energy is delivered only when adequate tissue engagement is detected to improve procedural effectiveness and safety.
Regarding claim 4, the combination of Alliger, Gregerson, Ligtenberg and Willyard teaches the limitations of claim 3, and Brannan teaches wherein the control circuit includes an electronic memory (8, Fig. 2) that stores a threshold longitudinal resistance pressure value corresponding to the threshold longitudinal resistance pressure (in order for the processor 82 to computationally compare the pressure level from the pressure transducer 70 with the threshold, the threshold value must be stored in memory for the processor to read and process),
the control circuit is configured to execute program instructions to compare a value of the catheter longitudinal pressure signal generated by the longitudinal pressure sensor to the threshold longitudinal resistance pressure value (paragraph 79, instructions are stored in memory 8 and executed by the processor 82 to perform the computational logic to compare the pressure level from the pressure transducer 70 with the predetermined threshold), and
the control circuit is configured to execute program instructions to activate the ultrasonic transducer to generate the ultrasonic vibrational energy when the value of the catheter longitudinal pressure signal is equal to or greater than the threshold longitudinal resistance pressure value (paragraph 51-52, 79, program instructions are executed by the processor 82 to perform computational logic to compare the pressure level from the pressure transducer 70 with the predetermined threshold and if the pressure level is above the threshold will enable energy delivery between the electrosurgical power generating source 28 to the probe 100).
Regarding claim 5, the combination of Alliger, Gregerson, Ligtenberg and Willyard teaches the limitations of claim 3, and Ligtenberg teaches a set of electrical conductors (74, Fig. 2) coupled in electrical communication with each of the longitudinal pressure sensor and the control circuit (col. 4 line 38-42, Figs. 1-2).
Regarding claim 6, the combination of Alliger, Gregerson, Ligtenberg and Willyard teaches the limitations of claim 5, and Ligtenberg teaches wherein the set of electrical conductors extends proximally from the longitudinal pressure sensor along a length of the elongate flexible catheter sheath (col. 4 line 38-42, Figs. 1-2).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Alliger in view of Gregersen as applied to claim 1 above, and further in view of Ligtenberg.
Regarding claim 8, the combination of Alliger and Gregersen teaches the limitations of claim 1.
The combination is silent on wherein the longitudinal pressure sensor is a pressure transducer configured to convert pressure into an electrical signal by a physical deformation of a portion of the pressure transducer, which then produces the catheter longitudinal pressure signal, wherein the catheter longitudinal pressure signal is proportional to the pressure that causes the physical deformation.
However, Ligtenberg teaches a device for measuring pressure within a patient body (abstract, col. 1 line 5-17) having a pressure transducer (12, Fig. 1-2) that converts pressure into an electrical signal by a physical deformation of a portion of the pressure transducer (col. 1 line 65 – col. 2 line 24, col. 3 line 4-25) wherein the pressure signal is proportional to the pressure that causes the physical deformation (inherent in strain-gauge measurements).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Alliger with Gregersen with the teachings of Ligtenberg in order to provide sufficient pressure responsiveness and meaningful electrical output signals as disclosed by Ligtenberg (col. 1 line 45-50, col. 6 line 37-43).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Alliger in view of Gregersen as applied to claim 1 above, and further in view of US 20100305448 Dagonneau et al. (hereinafter Dagonneau).
Regarding claim 9, the combination of Alliger and Gregersen teaches the limitations of claim 1.
The combination is silent on comprising an activation indicator LED that is configured to provide a visual indication to a user of an activation of the ultrasonic transducer.
However, Dagonneau teaches an ultrasound probe (132, Fig. 2, abstract) having a transducer (104, Fig. 1, paragraph 23) and an LED (133, Fig. 2), wherein the LED is configured to illuminate when the probe is active (abstract, paragraph 2, 4, 35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Alliger with Gregersen with the teachings of Dagonneau in order to allow the operator to know when the device is activated.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Alliger in view of Gregersen as applied to claim 1 above, and further in view of US 20150305708 Stigall et al. (hereinafter Stigall).
Regarding claim 10, the combination of Alliger and Gregersen teaches the limitations of claim 1.
The combination is silent on comprising a guidewire, and wherein the ultrasonic catheter includes a guidewire lumen that is configured to receive the guidewire.
However, Stigall teaches a device for imaging and pressure sensing a target region of a patient (abstract, paragraph 2) comprising a catheter (700, Fig. 9), the catheter further comprising a guidewire (702) and a guidewire lumen that is configured to receive the guidewire (paragraph 14, 64-65, as seen in Fig. 9, a lumen for the guidewire 702 to pass through).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modification of Alliger with Gregersen with the teachings of Stigall in order to accurately position the catheter to a target location within a patient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHOA TAN LE whose telephone number is (703)756-1252. The examiner can normally be reached Monday - Friday 8am - 4:30pm.
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/KHOA TAN LE/Examiner, Art Unit 3771 /MOHAMED G GABR/Primary Examiner, Art Unit 3771
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