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 5, 6, 8, 9, 17, 18, and 19 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 5, the claim limitation recites between “between approximately 0.05 MPa and 8.0 MPa” in lines 2-3. It is unclear what the scope of “approximately” is. The term “approximately” 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, the limitation shall be considered as “between 0.05 MPa and 8.0 MPa”.
Regarding claim 6, the claim limitation recites between “between approximately .3Hz and 15Hz” in lines 2-3. It is unclear what the scope of “approximately” is. The term “approximately” 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, the limitation shall be considered as “between .3 Hz and 15 Hz”.
Regarding claim 8, line 3 recites “(i)…(ii)”. However, it is unclear if the (i) and (ii) here replace the (i) and (ii) recited in the claim 1 of which claim 8 ultimately depends or if it is in addition to the (i) and (ii) of claim 1. For examination purposes, it shall be considered as in addition to.
Regarding claim 9, line 3 recites “(i)…(ii)”. However, it is unclear if the (i) and (ii) here replace the (i) and (ii) recited in the claim 1 of which claim 9 ultimately depends or if it is in addition to the (i) and (ii) of claim 1. For examination purposes, it shall be considered as in addition to.
Regarding claim 17, the claim limitation recites between “between approximately 10 seconds and 60 seconds” in line 2. It is unclear what the scope of “approximately” is. The term “approximately” 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, the limitation shall be considered as “between 10 seconds and 60 seconds”).
Regarding claim 18, line 3 recites “(i)…(ii)”. However, it is unclear if the (i) and (ii) here replace the (i) and (ii) recited in the claim 14 of which claim 18 ultimately depends or if it is in addition to the (i) and (ii) of claim 14. For examination purposes, it shall be considered as in addition to.
Regarding claim 19, line 3 recites “(i)…(ii)”. However, it is unclear if the (i) and (ii) here replace the (i) and (ii) recited in the claim 14 of which claim 19 ultimately depends or if it is in addition to the (i) and (ii) of claim 14. For examination purposes, it shall be considered as in addition to.
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, 4, 5, 6, 11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Milner et al., (US20220183756A1) in view of Chisena et al., (US20220287730A1) and in further view of Furomoto et al., (WO 8606269 A1).
Regarding claim 1, Milner teaches a catheter system for treating a treatment site within or adjacent to a vessel wall of a blood vessel, or within or adjacent to a heart valve, the catheter system comprising (Fig. 3 the device is used in an artery [0054]):
an energy source that generates a plurality of energy pulses (fig. 2 laser source 130 generates pulses [0053]);
an energy guide that receives the plurality of energy pulses from the energy source, the energy guide guiding the plurality of energy pulses from a guide proximal end to a guide distal end of the energy guide (fig. 2 optical fiber transfers the energy [0076]);
a balloon (fig. 3 expandable member 110 [0053]) including a balloon wall that defines a balloon interior (fig. 3 expandable member 110 has a wall), the balloon being configured to retain a catheter fluid within the balloon interior (fig. 3 fluid 115 [0054]), the guide distal end of the energy guide being positioned within the balloon interior (fig. 3 optical fiber 120 is within the balloon); and
a system controller including a processor that controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) a pulse frequency of the plurality of energy pulses ([0053] the control system controls the frequency), and (ii) an energy level for each of the plurality of energy pulses that are generated by the energy source ([0053] the control system controls operation of the laser light source; [0087] the system generates pressures around 50 bars of pressure);
However, Milner is silent regarding the system controller being configured to implement an energy control algorithm
In the same lithotripsy field of endeavor, Chisena teaches the system controller being configured to implement an energy control algorithm ([0105] algorithms can be used to control therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
However, the combination of reference fails to teach wherein as the pulse frequency of the plurality of energy pulses increases, the energy level for each of the plurality of energy pulses decreases.
In the same lithotripsy field of endeavor, Furomoto teaches wherein as the pulse frequency of the plurality of energy pulses increases, the energy level for each of the plurality of energy pulses decreases (fig. 5 teaches the negative relationship between energy and pulse repetition rate pg. 7 lines 6-15).
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 lithotripsy system of modified Tulip to incorporate the negative relationship between frequency and energy level for each of the pulses, as this would allow for the system to break down a variety of different stones (see Furomoto pg. 7 lines 21-22).
Regarding claim 2, modified Milner teaches the system of claim 1, wherein Milner further teaches control both of (i) a pulse frequency of the plurality of energy pulses, ([0053] the control system controls the frequency), and (ii) an energy level for each of the plurality of energy pulses that are generated by the energy source ([0053] the control system controls operation of the laser light source such as amplitude).
However, modified Milner is silent regarding wherein implementation of the energy control algorithm enables the system controller to automatically control.
In the same lithotripsy field of endeavor, Chisena teaches implementation of the energy control algorithm enables the system controller to automatically control ([0105] algorithms can be used to automatically adjust therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
Regarding claim 4, modified Milner teaches the system of claim 1, but fails to explicitly disclose wherein there is a negative non-linear relationship between the energy level for each of the plurality of energy pulses and the pulse frequency of the pulse frequency of the plurality of energy pulses.
In the same lithotripsy field of endeavor, Furomoto wherein there is a negative non-linear relationship between the energy level for each of the plurality of energy pulses and the pulse frequency of the pulse frequency of the plurality of energy pulses (fig. 5 teaches the negative relationship between energy and pulse repetition rate pg. 7 lines 6-15).
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 lithotripsy system of modified Tulip to incorporate the negative relationship between frequency and energy level for each of the pulses, as this would allow for the system to break down a variety of different stones (see Furomoto pg. 7 lines 21-22).
Regarding claim 5, modified Milner teaches the system of claim 1, wherein Milner further teaches wherein the energy level of each of the plurality of energy pulses that are generated by the energy source are between approximately 0.05 MPa and 8.0 MPa ([0057] the system can achieve pressures of 50 bars).
Regarding claim 6, modified Milner teaches the system of claim 1, but fails to explicitly disclose wherein the pulse frequency of the plurality of energy pulses that are generated by the energy source are between approximately 0.3 Hz and 15.0 Hz.
However in the same lithotripsy field of endeavor, Chisena teaches wherein the pulse frequency of the plurality of energy pulses that are generated by the energy source are between approximately 0.3 Hz and 15.0 Hz ([0043] the frequency of the pulsatile frequency ranges from 0-25 hz).
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 frequency of modified Milner with the frequency of Chisena, as this would impart sufficient energy to treat the tissue (see Chisena [0043]).
Regarding claim 11, modified Milner teaches the system of claim 1, wherein Milner further teaches a catheter shaft (fig. 10 expandable member 110 is coupled to a catheter 114 [0059]), the balloon being coupled to the catheter shaft (fig. 10 expandable member 110 is coupled to a catheter 114 [0059]); and wherein the balloon is selectively inflated with the catheter fluid to expand to an inflated state (fig. 3 the expandable member 110 is filled with fluid 115), the balloon wall being positionable adjacent to the treatment site when the balloon is in the inflated state (fig. 3 the expandable member 110 is adjacent to artery 250).
Regarding claim 13, modified Milner teaches the system of claim 1, wherein Milner further teaches the energy source is a light source that generates a plurality of light energy pulses (fig. 2 laser light source 130 [0053]); and wherein the energy guide is an optical fiber. (fig. 2 optical fiber 20 [0053])
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena and Furomoto as applied to claim 1 above, and further in view of Stolz et al., (US 20050035097 A1).
Regarding claim 3, modified Milner teaches the system of claim 1, but fails to teach a negative linear relationship between the energy level for each of the plurality of energy pulses and the pulse frequency of the plurality of energy pulses.
In the same laser field of endeavor, Stolz teaches a negative linear relationship between the energy level for each of the plurality of energy pulses and the pulse frequency of the plurality of energy pulses ([0029] at higher repetition rates, there is a linear decrease in pulse energy).
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 a negative linear relationship between energy and frequency as taught by Stolz to the base system of modified Milner, as both inventions relate to laser systems and would yield the predictable result of a lithotripsy system wherein the energy would decrease linearly when compared with frequency to one of ordinary skill in the art. One of ordinary skill would be able to apply such a technique, and the results of modified Milner having a negative linear relationship between energy levels and frequency are reasonably predictable. This would lead to an improvement in treatment consistency and simpler control algorithms.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena and Furomoto as applied to claim 1 above, and further in view of Chia et al., (US20180303549A1).
Regarding claim 7, modified Milner teaches the system of claim 1, wherein Milner further teaches wherein a treatment cycle is defined by a specified number of energy pulses being generated by the energy source over a specified period of time ([0053] operational parameters include pulse duration and frequency, which means the number of energy pulses and time are known) but fails to explicitly disclose wherein the energy level of a final energy pulse at an end of the treatment cycle is greater than the energy level of a first energy pulse at a beginning of the treatment cycle.
In the same lithotripsy field of endeavor, Chia teaches wherein the energy level of a final energy pulse at an end of the treatment cycle is greater than the energy level of a first energy pulse at a beginning of the treatment cycle ([0019] a first laser energy with a first power level is used on a stone, and then a second laser with a power level higher than the first is used).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of Tulip with the laser system of Chia, as both inventions relate to endoscopic lasers for lithotripsy, and yield the predictable result of a laser of a lithotripsy system wherein the final energy level is greater than the first energy level to one of ordinary skill. One of ordinary skill would be able to perform such a combination, and the results of Tulip having a system wherein the final energy level is greater than the first energy level. are reasonably predictable.
Regarding claim 8, modified Milner teaches the system of claim 7, wherein Milner further teaches the control system controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) the pulse width of each of the plurality of energy pulses, (iii) overall acoustic energy per treatment cycle, and (iv) the number of pulses per treatment cycle ([0053] the control system 135 controls operational parameters such as laser duration (width), frequency, and amplitude. The overall acoustic energy would be controlled with the control of frequency and amplitude, and the control of the duration and frequency would result in the control of the number of pulses per treatment cycle),but is silent regarding the system controller being configured to implement an energy control algorithm
In the same lithotripsy field of endeavor, Chisena teaches the system controller being configured to implement an energy control algorithm ([0105] algorithms can be used to control therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena, Furomoto, and Chia as applied to claim 8 above, and further in view of Hiereth et al., (US20150100048A1).
Regarding claim 9, modified Milner teaches the system of claim 8, wherein Milner further teaches the control system controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) the pulse width of each of the plurality of energy pulses, (iii) overall acoustic energy per treatment cycle, and (iv) the number of pulses per treatment cycle ([0053] the control system 135 controls operational parameters such as laser duration (width), frequency, and amplitude. The overall acoustic energy would be controlled with the control of frequency and amplitude, and the control of the duration and frequency would result in the control of the number of pulses per treatment cycle),but is silent regarding the system controller being configured to implement an energy control algorithm
In the same lithotripsy field of endeavor, Chisena teaches the system controller being configured to implement an energy control algorithm ([0105] algorithms can be used to control therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
However, Milner is silent regarding control of rise time of each of the plurality of energy pulses.
In the same lithotripsy field of endeavor, Hiereth teaches control of rise time of each of the plurality of energy pulses ([0032] the rise time can be modified).
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 modifying the rise time as taught by Hiereth to the base lithotripsy system of modified Milner, as both inventions relate to lithotripsy system and would yield the predictable result of a lithotripsy system that is able to modify its rise time to one of ordinary skill. One of ordinary skill would be able to apply such a technique, and the results of modified Milner being able to control the rise time are reasonably predictable. This would allow for improved control of the cavitation formations and more controlled energy transfer to the stone.
Claims 12 is rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena and Furomoto as applied to claim 1 above, and further in view of Cook et al., (US20220354578A1).
Regarding claim 12, modified Milner teaches the system of claim 11, but fails to explicitly teach a plasma generator that is positioned near the guide distal end of the energy guide, the plurality of energy pulses that are received by the energy guide being emitted from the guide distal end and contacting the plasma generator so that plasma is generated in the catheter fluid retained within the balloon interior; and wherein the plasma generation causes bubble formation that generates a pressure wave that imparts pressure adjacent to the treatment site.
In the same lithotripsy field of endeavor, Cook teaches a plasma generator that is positioned near the guide distal end of the energy guide (fig. 1 plasma generator 133 is located near the guide distal end 122d [0073]), the plurality of energy pulses that are received by the energy guide being emitted from the guide distal end and contacting the plasma generator so that plasma is generated in the catheter fluid retained within the balloon interior ([0073] pulses of light are directed along the light guides to induce plasma formation); and wherein the plasma generation causes bubble formation that generates a pressure wave that imparts pressure adjacent to the treatment site ([0073] this plasma formation imparts pressure waves upon the treatment site 106).
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 Milner with the plasma generator of Cook, as this would allow for accurate measurement of the energy output which allows the determination of the conversion efficiency, which can then be used to assess the condition of the plasma generator and the guide to determine if the catheter is operating normally (see Cook [0175]).
Claims 14, 15, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena and in further view of Chia.
Regarding claim 14, Milner teaches a catheter system for treating a treatment site within or adjacent to a vessel wall of a blood vessel, or within or adjacent to a heart valve, the catheter system comprising (Fig. 3 the device is used in an artery [0054]):
an energy source that generates a plurality of energy pulses (fig. 2 laser source 130 generates pulses [0053]);
an energy guide that receives the plurality of energy pulses from the energy source, the energy guide guiding the plurality of energy pulses from a guide proximal end to a guide distal end of the energy guide (fig. 2 optical fiber transfers the energy [0076]);
a balloon (fig. 3 expandable member 110 [0053]) including a balloon wall that defines a balloon interior (fig. 3 expandable member 110 has a wall), the balloon being configured to retain a catheter fluid within the balloon interior (fig. 3 fluid 115 [0054]), the guide distal end of the energy guide being positioned within the balloon interior (fig. 3 optical fiber 120 is within the balloon); and
a system controller including a processor that controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) a pulse frequency of the plurality of energy pulses ([0053] the control system controls the frequency), and (ii) an energy level for each of the plurality of energy pulses that are generated by the energy source ([0053] the control system controls operation of the laser light source; [0087] the system generates pressures around 50 bars of pressure);
a treatment cycle is defined by a specified number of energy pulses being generated by the energy source over a specified period of time ([0053] operational parameters include pulse duration and frequency, which means the number of energy pulses and time are known).
However, Milner is silent regarding the system controller being configured to implement an energy control algorithm
In the same lithotripsy field of endeavor, Chisena teaches the system controller being configured to implement an energy control algorithm ([0105] algorithms can be used to control therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
However, the combination of references fails to explicitly disclose wherein the energy level of a final energy pulse at an end of the treatment cycle is greater than the energy level of a first energy pulse at a beginning of the treatment cycle.
In the same lithotripsy field of endeavor, Chia teaches wherein the energy level of a final energy pulse at an end of the treatment cycle is greater than the energy level of a first energy pulse at a beginning of the treatment cycle ([0019] a first laser energy with a first power level is used on a stone, and then a second laser with a power level higher than the first is used).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of Milner with the laser system of Chia, as both inventions relate to endoscopic lasers for lithotripsy, and yield the predictable result of a laser of a lithotripsy system wherein the final energy level is greater than the first energy level to one of ordinary skill. One of ordinary skill would be able to perform such a combination, and the results of Milner having a system wherein the final energy level is greater than the first energy level. are reasonably predictable.
Regarding claim 15, modified Milner teaches the system of claim 14, wherein Milner further teaches control both of (i) a pulse frequency of the plurality of energy pulses, ([0053] the control system controls the frequency), and (ii) an energy level for each of the plurality of energy pulses that are generated by the energy source ([0053] the control system controls operation of the laser light source such as amplitude).
However, modified Milner is silent regarding wherein implementation of the energy control algorithm enables the system controller to automatically control.
In the same lithotripsy field of endeavor, Chisena teaches implementation of the energy control algorithm enables the system controller to automatically control ([0105] algorithms can be used to automatically adjust therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
Regarding claim 18, modified Milner teaches the system of claim 14, wherein Milner further teaches the control system controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) the pulse width of each of the plurality of energy pulses, (iii) overall acoustic energy per treatment cycle, and (iv) the number of pulses per treatment cycle ([0053] the control system 135 controls operational parameters such as laser duration (width), frequency, and amplitude. The overall acoustic energy would be controlled with the control of frequency and amplitude, and the control of the duration and frequency would result in the control of the number of pulses per treatment cycle),but is silent regarding the system controller being configured to implement an energy control algorithm
In the same lithotripsy field of endeavor, Chisena teaches the system controller being configured to implement an energy control algorithm ([0105] algorithms can be used to control therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena, and Chia as applied to claim 14 above, and further in view of Hiereth
Regarding claim 16, modified Milner teaches the system of claim 14, but fails to teach wherein the energy level of the plurality energy pulses increases in one of a stepped manner, a linear manner, and a non-linear manner from the first energy pulse to the last energy pulse of the treatment cycle.
In the same lithotripsy field of endeavor, Hiereth teaches wherein the energy level of the plurality energy pulses increases in one of a stepped manner, a linear manner, and a non-linear manner from the first energy pulse to the last energy pulse of the treatment cycle ([0019] the laser intensity can increase exponentially or linearly).
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 energy level of modified Milner with the increasing energy level of Hiereth, as this would reduce the duration of treatment (see Hiereth [0022]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena, and Chia as applied to claim 14 above, and further in view of Massimini (US20200405391A1).
Regarding claim 17, modified Milner teaches the system of claim 14, but is silent wherein the treatment cycle lasts between approximately 10 seconds and 60 seconds.
In the same lithotripsy field of endeavor, Massimini teaches wherein the treatment cycle lasts between approximately 10 seconds and 60 seconds ([0087] the treatment time can vary from 5 to 20 seconds).
It would to modify the system of modified Milner to have treatment cycles with a duration as taught by Massimini, as this would allow for specific treatment sites and sizes of vascular lesion (see Massimini [0087]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Milner in view of Chisena and Chia as applied to claim 18 above, and further in view of Hiereth.
Regarding claim 19, modified Milner teaches the system of claim 18, wherein Milner further teaches the control system controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) the pulse width of each of the plurality of energy pulses, (iii) overall acoustic energy per treatment cycle, and (iv) the number of pulses per treatment cycle ([0053] the control system 135 controls operational parameters such as laser duration (width), frequency, and amplitude. The overall acoustic energy would be controlled with the control of frequency and amplitude, and the control of the duration and frequency would result in the control of the number of pulses per treatment cycle),but is silent regarding the system controller being configured to implement an energy control algorithm
In the same lithotripsy field of endeavor, Chisena teaches the system controller being configured to implement an energy control algorithm ([0105] algorithms can be used to control therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
However, Milner is silent regarding control of rise time of each of the plurality of energy pulses.
In the same lithotripsy field of endeavor, Hiereth teaches control of rise time of each of the plurality of energy pulses ([0032] the rise time can be modified).
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 modifying the rise time as taught by Hiereth to the base lithotripsy system of modified Milner, as both inventions relate to lithotripsy system and would yield the predictable result of a lithotripsy system that is able to modify its rise time to one of ordinary skill. One of ordinary skill would be able to apply such a technique, and the results of modified Milner being able to control the rise time are reasonably predictable. This would allow for improved control of the cavitation formations and more controlled energy transfer to the stone.
Claims 20 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Milner view of Chisena, and in further view of Furomoto, Chia, and Hiereth.
Regarding claim 20, Milner teaches a catheter system for treating a treatment site within or adjacent to a vessel wall of a blood vessel, or within or adjacent to a heart valve, the catheter system comprising (Fig. 3 the device is used in an artery [0054]):
an energy source that generates a plurality of energy pulses (fig. 2 laser source 130 generates pulses [0053]);
an energy guide that receives the plurality of energy pulses from the energy source, the energy guide guiding the plurality of energy pulses from a guide proximal end to a guide distal end of the energy guide (fig. 2 optical fiber transfers the energy [0076]);
a system controller including a processor that controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) a pulse frequency of the plurality of energy pulses ([0053] the control system controls the frequency), and (ii) an energy level for each of the plurality of energy pulses that are generated by the energy source ([0053] the control system controls operation of the laser light source; [0087] the system generates pressures around 50 bars of pressure);
a treatment cycle is defined by a specified number of energy pulses being generated by the energy source over a specified period of time ([0053] operational parameters include pulse duration and frequency, which means the number of energy pulses and time are known); and
the control system controls the energy source ([0053] control system 135 controls the operational parameters of the apparatus 100), the system controller being configured to control both of (i) the pulse width of each of the plurality of energy pulses, (iii) overall acoustic energy per treatment cycle, and (iv) the number of pulses per treatment cycle ([0053] the control system 135 controls operational parameters such as laser duration (width), frequency, and amplitude. The overall acoustic energy would be controlled with the control of frequency and amplitude, and the control of the duration and frequency would result in the control of the number of pulses per treatment cycle),
However, Milner is silent regarding the system controller being configured to implement an energy control algorithm
In the same lithotripsy field of endeavor, Chisena teaches the system controller being configured to implement an energy control algorithm ([0105] algorithms can be used to control therapeutic parameters).
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 Milner with the algorithms of Chisena, as it would reduce the time necessary for treatment and more accurately predict the energy required prior to administering therapy (see Chisena [0105]).
However, the combination of reference fails to teach wherein as the pulse frequency of the plurality of energy pulses increases, the energy level for each of the plurality of energy pulses decreases.
In the same lithotripsy field of endeavor, Furomoto teaches wherein as the pulse frequency of the plurality of energy pulses increases, the energy level for each of the plurality of energy pulses decreases (fig. 5 teaches the negative relationship between energy and pulse repetition rate pg. 7 lines 6-15).
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 lithotripsy system of modified Tulip to incorporate the negative relationship between frequency and energy level for each of the pulses, as this would allow for the system to break down a variety of different stones (see Furomoto pg. 7 lines 21-22).
However, the combination of references fails to explicitly disclose wherein the energy level of a final energy pulse at an end of the treatment cycle is greater than the energy level of a first energy pulse at a beginning of the treatment cycle.
In the same lithotripsy field of endeavor, Chia teaches wherein the energy level of a final energy pulse at an end of the treatment cycle is greater than the energy level of a first energy pulse at a beginning of the treatment cycle ([0019] a first laser energy with a first power level is used on a stone, and then a second laser with a power level higher than the first is used).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to combine the system of Milner with the laser system of Chia, as both inventions relate to endoscopic lasers for lithotripsy, and yield the predictable result of a laser of a lithotripsy system wherein the final energy level is greater than the first energy level to one of ordinary skill. One of ordinary skill would be able to perform such a combination, and the results of Milner having a system wherein the final energy level is greater than the first energy level. are reasonably predictable.
However the combination of references are silent regarding control of rise time of each of the plurality of energy pulses.
In the same lithotripsy field of endeavor, Hiereth teaches control of rise time of each of the plurality of energy pulses ([0032] the rise time can be modified).
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 modifying the rise time as taught by Hiereth to the base lithotripsy system of modified Milner, as both inventions relate to lithotripsy system and would yield the predictable result of a lithotripsy system that is able to modify its rise time to one of ordinary skill. One of ordinary skill would be able to apply such a technique, and the results of modified Milner being able to control the rise time are reasonably predictable. This would allow for improved control of the cavitation formations and more controlled energy transfer to the stone.
Regarding 21 modified Milner teaches the system of claim 20, wherein Milner further teaches a balloon (fig. 3 expandable member 110 [0053]) including a balloon wall that defines a balloon interior (fig. 3 expandable member 110 has a wall), the balloon being configured to retain a catheter fluid within the balloon interior (fig. 3 fluid 115 [0054]), the guide distal end of the energy guide being positioned within the balloon interior (fig. 3 optical fiber 120 is within the balloon).
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