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 .
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 3-7,10, and 13-16 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 3, lines 1-3 recite “wherein the TDR waveforms are generated in response to an impedance change through the one or more conductive waveguides created by a conductive element”. It is unclear if (1) the conductive element creates the impedance change, or (2) if the conductive element creates the conductive waveguides. For examination purposes, the first interpretation shall be used.
Regarding claim 10, line 2 recites “wavelength range of between about ten and fifteen megahertz”. It is unclear how a wavelength can have a unit of frequency. For examination purposes, it shall be considered as “frequency range of between about ten and fifteen megahertz”.
Further, the term “about” in claim 10 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For examination purposes, any frequency range will be sufficient as being about 10-15 MHz.
Claim 13 recites “based on the one or more longitudinal distance measurements. There is insufficient antecedent basis for this limitation. For examination purposes, it shall be considered as “based on the one or more distance measurements”.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
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 , 8-12, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan et al., (US20150257732A1) in view of Samuelson et al., (US5361776A) and in further view Lavy et al., (US20150216442A1).
Regarding claim 1, Ryan teaches a method of ultrasound measuring, the method comprising ([0009] method for using ultrasound to approximate dimension)
longitudinally actuating an ultrasound probe between a plurality of positions ([0055]-[0056] the device 10 is moved back and forth; [0025] the medical device 10 can be a catheter such as an IVUS)
while the ultrasound probe is at each of the plurality of positions:
transmitting ultrasound signals from at least one ultrasound transducer of the ultrasound probe toward a structure ([0051] the transducer is aimed at a desired structure and send the ultrasound waves)
obtaining signals responsive to the transmitted ultrasound signals ([0051] the ultrasound signals are received) and calculate distance measurements between the ultrasound probe and the structure based on each of the responsive signals ([0052] the distance is calculated from the transducer to the nearest structure using the signals);
transmitting electrical pulses through one or more conductive waveguides extending between a proximate end of the ultrasound probe and a portion of the probe distal to the proximate (fig. 1 the electrical conductors 32 in certain embodiments run from the transducers 18 to the proximal connector 26 and may run within the material of the body member 12 or along its outer surface 40 or along or within the central lumen 38 to conduct the electrical excitation provided to the proximal connector 26 to the transducer 18 and return the signal from the transducer 18 thereafter to the proximal connector 26, the electrical conductors 32 may be wires including twisted pair wire, coaxial cable, fiber optics, wave guides and other wire media as is well understood in the art. [0041]).
However, Ryan fails to explicitly disclose obtaining reflective signals responsive to the electrical pulses, the reflective signals representing a change in characteristics of the transmitted electrical pulses as they transmit through a particular longitudinal position of the one or more conductive waveguide.
In the same catheter field of endeavor, Samuelson teaches obtaining reflective signals responsive to the electrical pulses (col. 8 lines 10-12 the impedance sensor circuit applies a voltage to the lead toward the tip electrode; col. 8 lines 58-61 the blood vessels and heart chambers act as an extension of the lead 11 and their impedance variations are reflected back along the lead 11), the reflective signals representing a change in characteristics of the transmitted electrical pulses as they transmit through a particular longitudinal position of the one or more conductive waveguide (col. 4 lines 23-26 The shape of the Sensed voltage waveform arising in response to the leading edge of the interrogating pulse is related to the impedance as a function of distance down the lead; col. 4 lines 28-30These impedance changes determine the amplitude and phase of the reflections.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
However, the combination of references are still silent regarding calculating one or more longitudinal position measurements of the ultrasound probe based on the reflective signals responsive to the electrical pulses.
In the same medical probe field of endeavor, Lavy teaches calculating one or more longitudinal position measurements of the ultrasound probe based on the signals responsive to the electrical pulses ([0107]-[0109] the spatial measurements of the probe can be calculated using the reflected signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the positional measurements of Lavy, as this would assist the positioning of the device and allow for accurate insertion of the instrument (see Lavy [0075]).
Regarding claim 2, modified Ryan teaches the method of claim 1, but fails to explicitly disclose calculating the longitudinal measurements is based on analyzing time domain reflectometry (TDR) waveforms within the reflective signals.
In the same catheter field of endeavor, Samuelson teaches calculating the longitudinal measurements is based on analyzing time domain reflectometry (TDR) waveforms within the reflective signals (col. 12 lines 42-55 electrical signal measuring means 66 acquires a sample TDR wave form of the reflected electrical signal and are indicative of the location of the pacing lead).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
Regarding claim 8, modified Ryan teaches the method of claim 2, but fails to explicitly disclose wherein calculating the longitudinal position measurements is based on electrical pulses transmitted through one conductive waveguide.
In the same catheter field of endeavor, Samuelson teaches wherein calculating the longitudinal position measurements is based on electrical pulses transmitted through one conductive waveguide (col. 8 lines 10-25 the lead takes the voltage toward the electrode 10; The TOR impedance sensor circuit 14 measures spatial impedance by determining the potential difference between the pacemaker case 30 and the pacemaker input connection to the conductor within lead 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
Regarding claim 9, modified Ryan teaches the method of claim 2, but fails to explicitly disclose calculating the longitudinal position measurements is based on analyzing time domain reflectometry (TDR) waveforms.
In the same catheter field of endeavor, Samuelson teaches calculating the longitudinal position measurements is based on analyzing time domain reflectometry (TDR) waveforms (col. 12 lines 42-55 a sample TDR waveform is acquired of an electrical signal reflected in response to an applied electrical stimulus, and the location can be determined from the round trip time of flight of reflected echoes, and variations in their signal level).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
However, the combination of references fails to explicitly disclose radio frequency waves.
In the same catheter field of endeavor, Lavy teaches a radio frequency wave ([0004] The impedance spectrum of a particular tissue layer may be obtained by sweeping over the electromagnetic frequency of the input signal. The spectrum may be obtained, for example, by sweeping over a frequency range, or by time-domain reflectometry (TDR) or other suitable time-domain methods; [0127] the frequency of the signal can be 0.1 to 1 GHz )
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the radio frequency waves of Lavy, as this would assist the positioning of the device and allow for enhanced sensitivity (see Lavy [0127]).
Regarding claim 10, modified Ryan teaches the method of claim 1, but fails to explicitly disclose wherein the electrical pulses comprise a wavelength range of between about ten and fifteen megahertz.
In the same catheter field of endeavor, Lavy teaches wherein the electrical pulses comprise a wavelength range of between about ten and fifteen megahertz ([0127] the frequency of the signal can be 1 MHz to 10 GHz)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the radio frequency waves of Lavy, as this would assist the positioning of the device and allow for enhanced sensitivity (see Lavy [0127]).
Regarding claim 11, modified Ryan teaches the method of claim 2, but fails to explicitly disclose wherein a single waveguide is used and reflected energy is analyzed.
In the same catheter field of endeavor, Samuelson teaches wherein a single waveguide is used and reflected energy is analyzed (col. 8 lines 10-25 the lead takes the voltage toward the electrode 10; The TOR impedance sensor circuit 14 measures spatial impedance by determining the potential difference between the pacemaker case 30 and the pacemaker input connection to the conductor within lead 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
Regarding claim 12, modified Ryan teaches the method of claim 1, wherein Ryan further teaches wherein multiple waveguides are used and transmitted energy is analyzed ([0041] the electrical conductors 32 may be waveguides; [0040] the computer controls the electrical pulses and processes the data).
Regarding claim 17, Ryan teaches an ultrasound system for measuring dimension of a structure, the system comprising ([0009] ultrasound is used to approximate dimension):
a flexible body elongated along a longitudinal axis and assembled for insertion into the structure (fig. 7 body member 12 is made of a flexible body member [0029]);
at least one ultrasound transducer arranged on the flexible body (fig. 7 transducers 18);
one or more conductive waveguides extending between a proximate end of the flexible body and a portion of the flexible body distal to the proximate end ((fig. 1 the electrical conductors 32 in certain embodiments run from the transducers 18 to the proximal connector 26 and may run within the material of the body member 12 or along its outer surface 40 or along or within the central lumen 38 to conduct the electrical excitation provided to the proximal connector 26 to the transducer 18 and return the signal from the transducer 18 thereafter to the proximal connector 26);
one or more processors programmed and configured to ([0040] computer 36):
transmit ultrasound signals from at least one ultrasound transducer ([0051] the transducer is aimed at a desired structure and send the ultrasound waves)
obtain signals responsive to the transmitted ultrasound signals ([0051] the ultrasound signals are received) and calculating distance measurements between the ultrasound probe and the structure based on each of the responsive signals ([0052] the distance is calculated from the transducer to the nearest structure using the signals);
transmit electrical pulses through the one or more conductive waveguides extending between a proximate end of the ultrasound probe and a portion of the probe distal to the proximate (fig. 1 the electrical conductors 32 in certain embodiments run from the transducers 18 to the proximal connector 26 and may run within the material of the body member 12 or along its outer surface 40 or along or within the central lumen 38 to conduct the electrical excitation provided to the proximal connector 26 to the transducer 18 and return the signal from the transducer 18 thereafter to the proximal connector 26, the electrical conductors 32 may be wires including twisted pair wire, coaxial cable, fiber optics, wave guides and other wire media as is well understood in the art. [0041]).
However, Ryan fails to explicitly disclose obtain reflective signals responsive to the electrical pulses, the reflective signals representing a change in characteristics of the transmitted electrical pulses as they transmit through a particular longitudinal position of the one or more conductive waveguide.
In the same catheter field of endeavor, Samuelson teaches obtain reflective signals responsive to the electrical pulses (col. 8 lines 10-12 the impedance sensor circuit applies a voltage to the lead toward the tip electrode; col. 8 lines 58-61 the blood vessels and heart chambers act as an extension of the lead 11 and their impedance variations are reflected back along the lead 11), the reflective signals representing a change in characteristics of the transmitted electrical pulses as they transmit through a particular longitudinal position of the one or more conductive waveguide (col. 4 lines 23-26 The shape of the Sensed voltage waveform arising in response to the leading edge of the interrogating pulse is related to the impedance as a function of distance down the lead; col. 4 lines 28-30These impedance changes determine the amplitude and phase of the reflections.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
However, the combination of references are still silent regarding calculate one or more longitudinal position measurements of the ultrasound probe based on the reflective signals responsive to the electrical pulses.
In the same medical probe field of endeavor, Lavy teaches calculate one or more longitudinal position measurements of the ultrasound probe based on the signals responsive to the electrical pulses ([0107]-[0109] the spatial measurements of the probe can be calculated using the reflected signals).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the positional measurements of Lavy, as this would assist the positioning of the device and allow for accurate insertion of the instrument (see Lavy [0075]).
Regarding claim 18, modified Ryan teaches the system of claim 17, but fails to explicitly disclose calculating the longitudinal measurements is based on analyzing time domain reflectometry (TDR) waveforms within the reflective signals.
In the same catheter field of endeavor, Samuelson teaches calculating the longitudinal measurements is based on analyzing time domain reflectometry (TDR) waveforms within the reflective signals (col. 12 lines 42-55 electrical signal measuring means 66 acquires a sample TDR wave form of the reflected electrical signal and are indicative of the location of the pacing lead).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
Claims 3 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Samuelson and Lavy as applied to claim 2 and 18, respectively above, and further in view of Marshall et al., (US20170164925A1)
Regarding claim 3, modified Ryan teaches the method of claim 2, but fails to explicitly disclose wherein the TDR waveforms are generated in response to an impedance change through the one or more conductive waveguides created by a conductive element
In the same catheter field of endeavor, Samuelson teaches wherein the TDR waveforms are generated in response to an impedance change through the one or more conductive waveguides created by a conductive element (col. 4 lines 23-26 The shape of the Sensed voltage waveform arising in response to the leading edge of the interrogating pulse is related to the impedance as a function of distance down the lead; col. 4 lines 28-30These impedance changes determine the amplitude and phase of the reflections; col. 15 lines 39-40 the circuit employs the tip electrode for applying a voltage step and for measuring voltage reflections returning via lead 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
However, the combination of references are silent regarding a conductive element positioned along the ultrasound probe, wherein the conductive element is arranged to remain stationary as the ultrasound probe is longitudinally actuated.
In the same catheter field of endeavor, Marshall teaches a conductive element positioned along the ultrasound probe, wherein the conductive element is arranged to remain stationary as the ultrasound probe is longitudinally actuated (fig. 1 The distal section 110 includes the rotating imaging core and a portion of the rotating driveshaft surrounded by a stationary distal sheath[0048]; [0066] inductive sensor 136 includes a coil 186 around the distal sheath, the inductance of coil 186 would vary as the magnetic material 188 is slid in or out of the sheath 158. The coil is stationary as the magnetic material moves in and out of the sheath).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the conductive sheath of Marshall, as this would allow for accurate pullback position information (Marshall [0052]).
Regarding claim 19, modified Ryan teaches the system of claim 18, but fails to explicitly disclose wherein the TDR waveforms are generated in response to an impedance change through the one or more conductive waveguides created by a conductive element
In the same catheter field of endeavor, Samuelson teaches wherein the TDR waveforms are generated in response to an impedance change through the one or more conductive waveguides created by a conductive element (col. 4 lines 23-26 The shape of the Sensed voltage waveform arising in response to the leading edge of the interrogating pulse is related to the impedance as a function of distance down the lead; col. 4 lines 28-30These impedance changes determine the amplitude and phase of the reflections; col. 15 lines 39-40 the circuit employs the tip electrode for applying a voltage step and for measuring voltage reflections returning via lead 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of Ryan with the sensor of Samuelson, as this would accomplish substantial improvements in distinguishing impedance signals arising from diverse physiological origins such as respiration and heart motion, and improving physiological signal fidelity by reducing signals arising from the electrode-electrolyte interface (see Samuelson col. 18 lines 51-58).
However, the combination of references are silent regarding a conductive element positioned along the ultrasound probe, wherein the conductive element is arranged to remain stationary as the ultrasound probe is longitudinally actuated.
In the same catheter field of endeavor, Marshall teaches a conductive element positioned along the ultrasound probe, wherein the conductive element is arranged to remain stationary as the ultrasound probe is longitudinally actuated (fig. 1 The distal section 110 includes the rotating imaging core and a portion of the rotating driveshaft surrounded by a stationary distal sheath[0048]; [0066] inductive sensor 136 includes a coil 186 around the distal sheath, the inductance of coil 186 would vary as the magnetic material 188 is slid in or out of the sheath 158. The coil is stationary as the magnetic material moves in and out of the sheath).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Ryan with the conductive sheath of Marshall, as this would allow for accurate pullback position information (Marshall [0052]).
Claims 4 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Samuelson and Lavy as applied to claim 3 and 19, respectively, above, and further in view of Morgan et al., (US6245066B1).
Regarding claim 4, modified Ryan teaches the method of claim 3, but fails to explicitly disclose wherein the conductive element comprises a movably slidable ring arranged about the ultrasound probe.
In the same catheter field of endeavor, Morgan teaches wherein the conductive element comprises a movably slidable ring arranged about the probe (col. 1 lines 48-52 tubular electrode 3 is axially slidable to the catheter 1; col. 2 lines 8-9 the material of the electrode 3 is an electrically conducting metal or alloy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the conductive element of the ultrasound probe of modified Ryan with the electrode of Morgan, as this both inventions relate to catheters, and would yield the predictable result of a method of ultrasound measuring with a tubular electrode that is slidable along the catheter to one of ordinary skill. One of ordinary skill would be able to perform such a substitution, and the results of modified Ryan having an tubular electrode that is slidable along the prong are reasonably predictable.
Regarding claim 20, modified Ryan teaches the system of claim 3, but fails to explicitly disclose wherein the conductive element comprises a movably slidable ring arranged about the ultrasound probe.
In the same catheter field of endeavor, Morgan teaches wherein the conductive element comprises a movably slidable ring arranged about the probe (col. 1 lines 48-52 tubular electrode 3 is axially slidable to the catheter 1; col. 2 lines 8-9 the material of the electrode 3 is an electrically conducting metal or alloy).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to substitute the conductive element of the ultrasound probe of modified Ryan with the electrode of Morgan, as this both inventions relate to catheters, and would yield the predictable result of a method of ultrasound measuring with a tubular electrode that is slidable along the catheter to one of ordinary skill. One of ordinary skill would be able to perform such a substitution, and the results of modified Ryan having an tubular electrode that is slidable along the prong are reasonably predictable.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Samuelson and Lavy as applied to claim 3, respectively, above, and further in view of Razavi et al., (US20120220848A1) and Sharma (US20160354140A1).
Regarding claim 5, modified Ryan teaches the method of claim 1, but fails to explicitly disclose wherein the conductive element is integrated within a trocar through which the ultrasound probe is arranged to pass.
In the same catheter field of endeavor, Razavi teaches wherein the conductive element is integrated within a tubular structure through which the ultrasound probe is arranged to pass ([0024] introducer 10 is used to insert a catheter into a blood vessel;[0030] the electrode is provided on the outer surface of the sheath).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of the electrode integrated withing the sheath as taught by Razavi to the conductive element of modified Ryan, as both inventions relate to catheters and would yield the predictable result of an ultrasound measuring system with conductive elements embedded in a tubular structure to one of ordinary skill. One of ordinary skill would be able to perform such an application, and the results of the conductive elements of modified Ryan being embedded in a tubular structure are reasonably predictable.
However, the combination references are still silent regarding a trocar through which the ultrasound probe is arranged to pass, the trocar configured with a mechanism for locking the trocar in place to the probe.
In the same catheter field of endeavor, Sharma teaches a trocar through which the ultrasound probe is arranged to pass, the trocar configured with a mechanism for locking the trocar in place to the probe (fig. 10K trocar 1056 allows catheter 1050 to pass, and locks with the catheter 1050[0557]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the tubular structure of modified Ryan with the trocar of Sharma, as this would allow for easy placement of the catheter (see Sharma [0557]).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Samuelson and Lavy as applied to claim 3 above, and further in view of Vollkron et al., (US20120078342A1)
Regarding claim 6, modified Ryan teaches the method of claim 3, but fails to explicitly disclose the conductive element comprises a fluid media in the structure within which the ultrasound probe is longitudinal actuated.
In the same catheter field of endeavor, Vollkron teaches the conductive element comprises a fluid media in the structure within which the ultrasound probe is longitudinal actuated ([0009] the electrodes on the advancing catheter are brought into electrically conductive contact with the surrounding blood).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan to use the surrounding blood as taught by Vollkron, as this would allow for quick and exact determination of the position of the catheter (see Vollkron [0006]).
Regarding claim 7, modified Ryan teaches the method of claim 6, but fails to explicitly disclose the fluid media comprises blood.
In the same catheter field of endeavor, Vollkron teaches the fluid media comprises blood ([0009] the electrodes on the advancing catheter are brought into electrically conductive contact with the surrounding blood).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan to use the surrounding blood as taught by Vollkron, as this would allow for quick and exact determination of the position of the catheter (see Vollkron [0006]).
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Samuelson and Lavy as applied to claim 2 above, and further in view of Burgess et al., (US20120130242A1).
Regarding claim 13, modified Ryan teaches the method of claim 1, wherein Ryan further teaches wherein, based on the calculated distance measurements between the ultrasound probe and the structure, determining a plurality of cross- sectional shapes of the structure ([0053] a cross-section can be determined of the structure when the distances between the transducer and the structure are calculated) but fails to explicitly disclose based on the one or more longitudinal distance measurements, determining a longitudinal distance between the distances.
In the same intravascular field of endeavor, Burgess teaches based on the one or more longitudinal distance measurements, determining a longitudinal distance between the cross sectional shapes (fig. 5 The display 500 additionally shows a measurement 523 of the distance 524 between the cross-sectional images 504 and 506[0063]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the distance measuring of Burgess, as this would facilitate stent sizing (see Burgess [0063]).
Regarding claim 16, modified Ryan teaches the method of claim 13, but fails to explicitly disclose wherein the plurality of cross-sectional shapes are registered in computer memory as relative longitudinal positions within the structure based on the one or more longitudinal measurements.
In the same intravascular field of endeavor, Burgess teaches wherein the plurality of cross-sectional shapes are registered in computer memory as relative longitudinal positions within the structure based on the one or more longitudinal measurements ([0048] the longitudinal view can include markers 422 and 424 that indicate the first and second cross sectional images 404 and 406, which means the cross section images would be registered in the computer memory; [0049] the markers 422 and 424 are show indicating the relative positioning of the cross sectional images).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the distance measuring of Burgess, as this would facilitate stent sizing (see Burgess [0063]).
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ryan in view of Samuelson, Lavy, and Burgess applied to claim 13 above, and further in view of Schmitt et al., (US20110071404A1).
Regarding claim 14, modified Ryan teaches the method of claim 13, but fails to explicitly disclose determining one or more longitudinal shapes of the structure based on the plurality of cross-sectional shapes and one or more longitudinal distances.
In the same intravascular field of endeavor Schmitt teaches determining one or more longitudinal shapes of the structure based on the plurality of cross-sectional shapes and one or more longitudinal distances ([0060]-[0061] lumen contours are determined respective cross sectional image frames, and a mean diameter is calculated for each cross section; [0076] an area vs longitudinal position graph is constructed from the individually calculated cross section areas; [0114] the image process system generates a data set showing the mean diameter for each cross section along the catheter axis, calculates the diameter from the cross section area at each longitudinal position, and there by generates a longitudinal vessel profile).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the method of modified Ryan with the cross section processing of Schmitt, as this would optimize stent sizing and positioning (see Schmitt [0013]).
Regarding claim 15, modified Ryan teaches the method of claim 14, wherein Ryan further teaches determining a three-dimensional shape of the structure based on the determined longitudinal shapes and the plurality of cross-sectional shapes ([0054]-[0056] the transducers generate 2D cross sections and are used, along with the distance measurements, to produce a 3D structure).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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, Pascal Bui-Pho can be reached at 5712722714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
Prosecution Insights