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 .
Information Disclosure Statement
The information disclosure statement (IDS) was submitted on 11/26/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim 16 is 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.
Claim 16 recites the limitation "the shockwave generating techniques" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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, 10, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli et al. (U.S. Pub. No. 20140257144) hereinafter Capelli, in view of Theuer (DE 44 14 239 A1) hereinafter Theuer ‘239 (see attached combined English translation for citations).
Regarding claim 1, primary reference Capelli teaches:
A method for selective destruction of malignant cells in a target volume of a living organism (abstract), comprising
activating at least one shockwave generator of a treatment device for enabling shockwaves to be emitted from at least one applicator of the treatment device ([0022], pulse-generation of shock waves using one or more EH tips; [0023], shockwave therapies; [0024]-[0026]; [0038]-[0040]; [0070]-[0075], describe apparatus 10 with spark head 22 which produces the impulses from the pulse generation system 26 as shock waves to a patient; [0077]-[0091], describe the shock wave generator in greater detail; [0106], cancer treatment; [0116], EH generated shock waves to a patient; [0118], “cancer cells”; [0129], cancerous tumor; [0130]; [0134], “Some embodiments of the present methods of treating tumors or other maladies include multiple applications of shockwaves to targeted tissue (e.g., a tumor”)),
Primary reference Capelli fails to teach:
wherein said activating includes setting a prescribed delay time between temporally successive shockwaves, wherein the prescribed delay time is determined as a function of an extension characteristic of said malignant cells and healthy cells within the target volume, and wherein the prescribed delay time precludes said healthy cells within the target volume from achieving a lethal level of extension in response to exposure to said shockwaves prior to said malignant cells reaching a lethal level of extension; and
applying, via the at least one shockwave applicator, a plurality of shockwaves into the target volume, wherein said applying in accordance with the prescribed delay time causes a current one of said shockwaves to be applied to the target volume while said malignant cells therein remain in a state of extension caused by an immediately prior one of said shockwaves applied to the target volume thereby enabling said malignant cells to reach the lethal level of extension through extension build-up caused by successive impulse fields
However, the analogous art of Theuer ‘239 of a device for treatment of diseased cells and malignant tissue within the body (abstract) teaches:
wherein said activating includes setting a prescribed delay time between temporally successive shockwaves, wherein the prescribed delay time is determined as a function of an extension characteristic of said malignant cells and healthy cells within the target volume, and wherein the prescribed delay time precludes said healthy cells within the target volume from achieving a lethal level of extension in response to exposure to said shockwaves prior to said malignant cells reaching a lethal level of extension ([0013], selective destruction of cells with a certain pathological condition appearance and generated targeted treatment for the respective cell type; [0014], teaches to information related to mechanical attributes of malignant cells; [0015], teaches to cancer cell specific destruction which provides for malignant cells of a tumor; [0016], vibration properties of pathologically altered cells forms reception of information characterizing mechanical attributes; [0017]-[0022] describe frequency configuration and pulse configuration (impulse shape and/or sequences) for optimal destruction of selected cells; [0021]-[0022], pause durations form the delay time between successive tumor destructive impulses and is adjusted based upon the selected cells (see citation above regarding patient-individual treatment parameters); [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; [0043]-[0050]; [0053], cell dependent frequency spectrum; [0054]-[0055], pause durations of pulse trains selected based upon the targeted treatment tissue and surrounding healthy tissue, form adjusting of a delay time between pulses. Avoiding damage to healthy tissue forms a precluding of healthy cells from achieving a lethal level of extension in response to the exposure to the treatment); and
applying, via the at least one shockwave applicator, a plurality of shockwaves into the target volume, wherein said applying in accordance with the prescribed delay time causes a current one of said shockwaves to be applied to the target volume while said malignant cells therein remain in a state of extension caused by an immediately prior one of said shockwaves applied to the target volume thereby enabling said malignant cells to reach the lethal level of extension through extension build-up caused by successive impulse fields ([0013], selective destruction of cells with a certain pathological condition appearance and generated targeted treatment for the respective cell type; [0014], teaches to information related to mechanical attributes of malignant cells; [0015], teaches to cancer cell specific destruction which provides for malignant cells of a tumor; [0016], vibration properties of pathologically altered cells forms reception of information characterizing mechanical attributes; [0017]-[0022] describe frequency configuration and pulse configuration (impulse shape and/or sequences) for optimal destruction of selected cells; [0021]-[0022], pause durations form the delay time between successive tumor destructive impulses and is adjusted based upon the selected cells (see citation above regarding patient-individual treatment parameters); [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; [0043]-[0050]; [0053], cell dependent frequency spectrum; [0054]-[0055], pause durations of pulse trains selected based upon the targeted treatment tissue and surrounding healthy tissue, form adjusting of a delay time between pulses. Avoiding damage to healthy tissue while achieving a lethal level of extension to the diseased cells in response to the exposure to the treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli to incorporate the selective cancer cell targeted treatment pulses including pause time adjustment based upon measured cell information as taught by Theuer ‘239 because it provides for the specific type of targeted energy to destroy the targeted cells of interest based upon the known physical properties (Theuer ‘239, [0013]) while avoiding damaging healthy surrounding tissues (Theuer ‘239, [0017]).
Regarding claim 2, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 1. Primary reference Capelli further teaches:
wherein each of said shockwaves has a peak pressure amplitude from 0.01 MPa to 300 MPa and a rise time from 2 ns to 4000 ns ([0097], pulse amplitude at several MPa is within the claimed range and rise time in the nanosecond range up to 30 nanoseconds is also within claimed range; [0117]).
Regarding claim 10, primary reference Capelli teaches:
A treatment device for selective destruction of malignant cells in a target volume of a living organism, comprising
at least one applicator ([0022], pulse-generation of shock waves using one or more EH tips; [0023], shockwave therapies; [0024]-[0026]; [0038]-[0040]; [0070]-[0075], describe apparatus 10 with spark head 22 (shock wave applicator)which produces the impulses from the pulse generation system 26 as shock waves to a patient; [0077]-[0091], describe the EH generator in greater detail; [0106], cancer treatment; [0116], EH generated shock waves to a patient; [0118], “cancer cells”; [0129], cancerous tumor; [0130]; [0134], “Some embodiments of the present methods of treating tumors or other maladies include multiple applications of shockwaves to targeted tissue (e.g., a tumor”));
at least one shockwave generator connected to the at least one applicator for enabling shockwaves to be emitted therefrom ([0022], pulse-generation of shock waves using one or more EH tips; [0023], shockwave therapies; [0024]-[0026]; [0038]-[0040]; [0070]-[0075], describe apparatus 10 with spark head 22 which produces the impulses from the pulse generation system 26 (shock wave generator) as shock waves to a patient; [0077]-[0091], describe the EH generator in greater detail; [0106], cancer treatment; [0116], EH generated shock waves to a patient; [0118], “cancer cells”; [0129], cancerous tumor; [0130]; [0134], “Some embodiments of the present methods of treating tumors or other maladies include multiple applications of shockwaves to targeted tissue (e.g., a tumor”);); and
at least one control unit connected to the at least one shockwave generator for enabling operative control of the at least one shockwave generator and the at least one applicator connected thereto ([0070], separator controller or pulse generation system for providing the shockwave generation to the generator; [0099], controller), wherein said operative control includes:
Primary reference Capelli further fails to teach:
activating the at least one shockwave generator, wherein said activating includes setting a prescribed delay time between temporally successive shockwaves, wherein the prescribed delay time is determined as a function of an extension characteristic of said malignant cells and healthy cells within the target volume, and wherein the prescribed delay time precludes said healthy cells within the target volume from achieving a lethal level of extension in response to exposure to said shockwaves prior to said malignant cells achieving a lethal level of extension; and
outputting, via the at least one shockwave applicator, a plurality of shockwaves into the target volume, wherein said outputting in accordance with the prescribed delay time causes a current one of said shockwaves to be applied to the target volume while said malignant cells therein remain in a state of extension caused by an immediately prior one of said shockwaves applied to the target volume thereby enabling said malignant cells to reach the lethal level of extension through extension build-up caused by successive impulse fields
However, the analogous art of Theuer ‘239 of a device for treatment of diseased cells and malignant tissue within the body (abstract) teaches:
activating the at least one shockwave generator, wherein said activating includes setting a prescribed delay time between temporally successive shockwaves, wherein the prescribed delay time is determined as a function of an extension characteristic of said malignant cells and healthy cells within the target volume, and wherein the prescribed delay time precludes said healthy cells within the target volume from achieving a lethal level of extension in response to exposure to said shockwaves prior to said malignant cells achieving a lethal level of extension ([0013], selective destruction of cells with a certain pathological condition appearance and generated targeted treatment for the respective cell type; [0014], teaches to information related to mechanical attributes of malignant cells; [0015], teaches to cancer cell specific destruction which provides for malignant cells of a tumor; [0016], vibration properties of pathologically altered cells forms reception of information characterizing mechanical attributes; [0017]-[0022] describe frequency configuration and pulse configuration (impulse shape and/or sequences) for optimal destruction of selected cells; [0021]-[0022], pause durations form the delay time between successive tumor destructive impulses and is adjusted based upon the selected cells (see citation above regarding patient-individual treatment parameters); [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; [0043]-[0050]; [0053], cell dependent frequency spectrum; [0054]-[0055], pause durations of pulse trains selected based upon the targeted treatment tissue and surrounding healthy tissue, form adjusting of a delay time between pulses. Avoiding damage to healthy tissue forms a precluding of healthy cells from achieving a lethal level of extension in response to the exposure to the treatment); and
outputting, via the at least one shockwave applicator, a plurality of shockwaves into the target volume, wherein said outputting in accordance with the prescribed delay time causes a current one of said shockwaves to be applied to the target volume while said malignant cells therein remain in a state of extension caused by an immediately prior one of said shockwaves applied to the target volume thereby enabling said malignant cells to reach the lethal level of extension through extension build-up caused by successive impulse fields ([0013], selective destruction of cells with a certain pathological condition appearance and generated targeted treatment for the respective cell type; [0014], teaches to information related to mechanical attributes of malignant cells; [0015], teaches to cancer cell specific destruction which provides for malignant cells of a tumor; [0016], vibration properties of pathologically altered cells forms reception of information characterizing mechanical attributes; [0017]-[0022] describe frequency configuration and pulse configuration (impulse shape and/or sequences) for optimal destruction of selected cells; [0021]-[0022], pause durations form the delay time between successive tumor destructive impulses and is adjusted based upon the selected cells (see citation above regarding patient-individual treatment parameters); [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; [0043]-[0050]; [0053], cell dependent frequency spectrum; [0054]-[0055], pause durations of pulse trains selected based upon the targeted treatment tissue and surrounding healthy tissue, form adjusting of a delay time between pulses. Avoiding damage to healthy tissue while achieving a lethal level of extension to the diseased cells in response to the exposure to the treatment).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli to incorporate the selective cancer cell targeted treatment pulses including pause time adjustment based upon measured cell information as taught by Theuer ‘239 because it provides for the specific type of targeted energy to destroy the targeted cells of interest based upon the known physical properties (Theuer ‘239, [0013]) while avoiding damaging healthy surrounding tissues (Theuer ‘239, [0017]).
Regarding claim 16, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further teaches:
wherein the shockwave generating techniques are selected from a group consisting of ballistic shockwave generation, piezoelectric shockwave generation, electromechanical shockwave generation, and electrohydraulic shockwave generation ([0022], pulse-generation of shock waves using electrohydraulic shockwave generation; [0023], shockwave therapies; [0024]-[0026]; [0038]-[0040]; [0070]-[0075], describe apparatus 10 with spark head 22 which produces the impulses from the pulse generation system 26 as shock waves to a patient; [0077]-[0091], describe the shock wave generator in greater detail; [0106], cancer treatment; [0116], EH generated shock waves to a patient; [0118], “cancer cells”; [0129], cancerous tumor; [0130]; [0134], “Some embodiments of the present methods of treating tumors or other maladies include multiple applications of shockwaves to targeted tissue (e.g., a tumor”)).
Regarding claim 17, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further teaches:
wherein each of said shockwaves has a peak pressure amplitude from 0.01 MPa to 300 MPa and a rise time from 2 ns to 4000 ns ([0097], pulse amplitude at several MPa is within the claimed range and rise time in the nanosecond range up to 30 nanoseconds is also within claimed range; [0117]).
Claims 3-4 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239 as applied to claims 1 or 10 above, and further in view of Cioanta (U.S. Pub. No. 20160310766) hereinafter Cioanta.
Regarding claim 3, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 1. Primary reference Capelli further fails to teach:
wherein said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz
However, the analogous art of Cioanta of an acoustic pressure shock wave treatment system (abstract) teaches:
wherein said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz ([0080], repetition frequency; [0082], repetition frequency rate overlaps the claimed range with a teaching of 1 to 20 Hz; [0103]; [0107]; [0114]; [1020]-[0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shock wave tumor treatment device of Capelli and Theuer ‘239 to incorporate the shock repetition frequency as taught by Cioanta because it provides for sufficient depth of energy penetration within the target tissues of interest and cavitation formation, without damaging the healthy tissue structures within the overall treatment region (Cioanta, [0081]-[0082]; [0106]-[0107]). This provides for enhanced treatment, while reducing unwanted side effects.
Regarding claim 4, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 1. Primary reference Capelli further teaches:
wherein at least one of: each of said shockwaves has a peak pressure amplitude from 0.01 MPa to 300 MPa and a rise time from 2 ns to 4000 ns ([0097], pulse amplitude at several MPa is within the claimed range and rise time in the nanosecond range up to 30 nanoseconds is also within claimed range; [0117]); and
Primary reference Capelli further fails to teach:
said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz
However, the analogous art of Cioanta of an acoustic pressure shock wave treatment system (abstract) teaches:
said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz ([0080], repetition frequency; [0082], repetition frequency rate overlaps the claimed range with a teaching of 1 to 20 Hz; [0103]; [0107]; [0114]; [1020]-[0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shock wave tumor treatment device of Capelli and Theuer ‘239 to incorporate the shock repetition frequency as taught by Cioanta because it provides for sufficient depth of energy penetration within the target tissues of interest and cavitation formation, without damaging the healthy tissue structures within the overall treatment region (Cioanta, [0081]-[0082]; [0106]-[0107]). This provides for enhanced treatment, while reducing unwanted side effects.
Regarding claim 18, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further fails to teach:
wherein said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz
However, the analogous art of Cioanta of an acoustic pressure shock wave treatment system (abstract) teaches:
wherein said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz ([0080], repetition frequency; [0082], repetition frequency rate overlaps the claimed range with a teaching of 1 to 20 Hz; [0103]; [0107]; [0114]; [1020]-[0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shock wave tumor treatment device of Capelli and Theuer ‘239 to incorporate the shock repetition frequency as taught by Cioanta because it provides for sufficient depth of energy penetration within the target tissues of interest and cavitation formation, without damaging the healthy tissue structures within the overall treatment region (Cioanta, [0081]-[0082]; [0106]-[0107]). This provides for enhanced treatment, while reducing unwanted side effects.
Regarding claim 19, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further teaches:
wherein at least one of: each of said shockwaves has a peak pressure amplitude from 0.01 MPa to 300 MPa and a rise time from 2 ns to 4000 ns ([0097], pulse amplitude at several MPa is within the claimed range and rise time in the nanosecond range up to 30 nanoseconds is also within claimed range; [0117]); and
Primary reference Capelli further fails to teach:
said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz
However, the analogous art of Cioanta of an acoustic pressure shock wave treatment system (abstract) teaches:
said shockwaves are outputted at a repetition rate of 0.5 Hz to 600 Hz ([0080], repetition frequency; [0082], repetition frequency rate overlaps the claimed range with a teaching of 1 to 20 Hz; [0103]; [0107]; [0114]; [1020]-[0129]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shock wave tumor treatment device of Capelli and Theuer ‘239 to incorporate the shock repetition frequency as taught by Cioanta because it provides for sufficient depth of energy penetration within the target tissues of interest and cavitation formation, without damaging the healthy tissue structures within the overall treatment region (Cioanta, [0081]-[0082]; [0106]-[0107]). This provides for enhanced treatment, while reducing unwanted side effects.
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239, in further view of Cioanta as applied to claims 4 or 19 above, and further in view of Theuer (U.S. Pub. No. 20120109024) hereinafter Theuer ‘024, in further view of Reichenberger (U.S. Pat. No. 4664111) hereinafter Reichenberger ‘111.
Regarding claim 5, the combined references of Capelli, Theuer ‘239, and Cioanta teach all of the limitations of claim 4. Primary reference Capelli further fails to teach:
the treatment device includes a plurality of shockwave generators and a plurality of applicators;
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators; and
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
the treatment device includes a plurality of shockwave generators and a plurality of applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder);
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, and Cioanta to incorporate the positioning of a plurality of applicators relative to one another with pulsed output as taught by Theuer ‘024 because it enables alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space (Theuer ‘024, [0032]).
Primary reference Capelli further fails to teach:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves
However, the analogous art of Reichenberger ‘111 of a shock wave generator for delivering first and second time-staggered waves to a target of interest (abstract) teaches:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves (col 1, lines 32-37, “the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the concrement.”; col 1, lines 65-68, “If the appropriate dimensions are suitably chosen, two secondary shock waves can impinge on the concrement staggered in time in such a way that their actions overlap”; col 2, lines 31-65, right hand part 5a and left wave 5b form the sequentially generated impulses that are configured to have a temporal interval between arrival of the waves at the impulse field that is smaller than the duration of the first arriving impulse. This forms an impulse field with two (a plurality) of overlapping impulses as claimed; As shown in figure 1, reflectors 11 and 13 form at least two of the impulse applicators applying first and second waves to emit the waves in a time-staggered manner to the target location; col 2, line 66 through col 3, line 21 further discuss the time delay of 10 microseconds as an example in which the impulse arrivals are sequential, with the temporal interval between impulses small enough to enable superposition of the wave action at the target tissue region of interest)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, Cioanta, and Theuer ‘024 to incorporate the overlapping destructive impulses at the target region of interest in a time-staggered manner by adjacent applicators as taught by Reichenberger ‘111 because the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the treatment site (Reichenberger ‘111, col 1, lines 32-37). This leads to improved treatment efficiency, leading to better results at a reduced cost.
Regarding claim 20, the combined references of Capelli, Theuer ‘239, and Cioanta teach all of the limitations of claim 19. Primary reference Capelli further fails to teach:
the treatment device includes a plurality of shockwave generators and a plurality of applicators;
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
the treatment device includes a plurality of shockwave generators and a plurality of applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder);
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, and Cioanta to incorporate the positioning of a plurality of applicators relative to one another with pulsed output as taught by Theuer ‘024 because it enables alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space (Theuer ‘024, [0032]).
Primary reference Capelli further fails to teach:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves
However, the analogous art of Reichenberger ‘111 of a shock wave generator for delivering first and second time-staggered waves to a target of interest (abstract) teaches:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves (col 1, lines 32-37, “the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the concrement.”; col 1, lines 65-68, “If the appropriate dimensions are suitably chosen, two secondary shock waves can impinge on the concrement staggered in time in such a way that their actions overlap”; col 2, lines 31-65, right hand part 5a and left wave 5b form the sequentially generated impulses that are configured to have a temporal interval between arrival of the waves at the impulse field that is smaller than the duration of the first arriving impulse. This forms an impulse field with two (a plurality) of overlapping impulses as claimed; As shown in figure 1, reflectors 11 and 13 form at least two of the impulse applicators applying first and second waves to emit the waves in a time-staggered manner to the target location; col 2, line 66 through col 3, line 21 further discuss the time delay of 10 microseconds as an example in which the impulse arrivals are sequential, with the temporal interval between impulses small enough to enable superposition of the wave action at the target tissue region of interest)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, Cioanta, and Theuer ‘024 to incorporate the overlapping destructive impulses at the target region of interest in a time-staggered manner by adjacent applicators as taught by Reichenberger ‘111 because the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the treatment site (Reichenberger ‘111, col 1, lines 32-37). This leads to improved treatment efficiency, leading to better results at a reduced cost.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239, in view of Cioanta, in view of Theuer ‘024, in further view of Reichenberger ‘111 as applied to claim 5 above, and further in view of Theuer (DE 103 02 438 A1) hereinafter Theuer ‘438 (see attached English translation for citations).
Regarding claim 6, the combined references of Capelli, Theuer ‘239, Cioanta, Theuer ‘024, and Reichenberger ‘111 teach all of the limitations of claim 5. Primary reference Capelli further fails to teach:
the target volume is pre-heated to between about 39 °C and about 41 °C before application of said shockwaves to increase sensitivity of said malignant cells to said shockwaves; and
However, the analogous art of Theuer ‘438 of an ultrasonic device used for selective destruction of diseased body cells such as tumors ([0001]; [0004]) teaches:
the target volume is pre-heated to between about 39 °C and about 41 °C before application of said shockwaves to increase sensitivity of said malignant cells to said shockwaves ([0041], pre-sonication; [0050]-[0051], the range of 15 °C to 42 °C is within the claimed range. As this is the operable range for treatment, application of shockwaves also occurs after the volume is heated to operable temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, Cioanta, Theuer ‘024, and Reichenberger ‘111 to incorporate the treatment temperature range as taught by Theuer ‘438 because healthy tissue can withstand high levels of sonication without damage which enables selective treatment of targeted cells within the target tissue region (Theuer ‘438, [0012]).
Primary reference Capelli further fails to teach:
the prescribed delay time between at least one instance of said temporally successive shockwaves can be adjusted during said applying
However, the analogous art of Theuer ‘239 of a device for treatment of diseased cells and malignant tissue within the body (abstract) teaches:
the prescribed delay time between at least one instance of said temporally successive shockwaves can be adjusted during said applying ([0013], selective destruction of cells with a certain pathological condition appearance and generated targeted treatment for the respective cell type; [0014], teaches to information related to mechanical attributes of malignant cells; [0015], teaches to cancer cell specific destruction which provides for malignant cells of a tumor; [0016], vibration properties of pathologically altered cells forms reception of information characterizing mechanical attributes; [0017]-[0022] describe frequency configuration and pulse configuration (impulse shape and/or sequences) for optimal destruction of selected cells; [0021]-[0022], pause durations form the delay time between successive tumor destructive impulses and is adjusted based upon the selected cells (see citation above regarding patient-individual treatment parameters); [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; [0043]-[0050]; [0053], cell dependent frequency spectrum; [0054]-[0055], pause durations of pulse trains selected based upon the targeted treatment tissue and surrounding healthy tissue, form adjusting of a delay time between pulses. Avoiding damage to healthy tissue provides for adjustment of delay time during application).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, Cioanta, Theuer ‘024, Reichenberger ‘111, and Theuer ‘438 to incorporate the selective cancer cell targeted treatment pulses including pause time adjustment based upon measured cell information as taught by Theuer ‘239 because it provides for the specific type of targeted energy to destroy the targeted cells of interest based upon the known physical properties (Theuer ‘239, [0013]) while avoiding damaging healthy surrounding tissues (Theuer ‘239, [0017]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239, in further view of Cioanta as applied to claim 4 above, and further in view of Theuer ‘438.
Regarding claim 7, the combined references of Capelli, Theuer ‘239, and Cioanta teach all of the limitations of claim 4. Primary reference Capelli further fails to teach:
the target volume is pre-heated to between about 39 °C and about 41 °C before application of said shockwaves to increase sensitivity of said malignant cells to said shockwaves; and
However, the analogous art of Theuer ‘438 of an ultrasonic device used for selective destruction of diseased body cells such as tumors ([0001]; [0004]) teaches:
the target volume is pre-heated to between about 39 °C and about 41 °C before application of said shockwaves to increase sensitivity of said malignant cells to said shockwaves ([0041], pre-sonication; [0050]-[0051], the range of 15 °C to 42 °C is within the claimed range. As this is the operable range for treatment, application of shockwaves also occurs after the volume is heated to operable temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, and Cioanta to incorporate the treatment temperature range as taught by Theuer ‘438 because healthy tissue can withstand high levels of sonication without damage which enables selective treatment of targeted cells within the target tissue region (Theuer ‘438, [0012]).
Primary reference Capelli further fails to teach:
the prescribed delay time between at least one instance of said temporally successive shockwaves can be adjusted during said applying
However, the analogous art of Theuer ‘239 of a device for treatment of diseased cells and malignant tissue within the body (abstract) teaches:
the prescribed delay time between at least one instance of said temporally successive shockwaves can be adjusted during said applying ([0013], selective destruction of cells with a certain pathological condition appearance and generated targeted treatment for the respective cell type; [0014], teaches to information related to mechanical attributes of malignant cells; [0015], teaches to cancer cell specific destruction which provides for malignant cells of a tumor; [0016], vibration properties of pathologically altered cells forms reception of information characterizing mechanical attributes; [0017]-[0022] describe frequency configuration and pulse configuration (impulse shape and/or sequences) for optimal destruction of selected cells; [0021]-[0022], pause durations form the delay time between successive tumor destructive impulses and is adjusted based upon the selected cells (see citation above regarding patient-individual treatment parameters); [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; [0043]-[0050]; [0053], cell dependent frequency spectrum; [0054]-[0055], pause durations of pulse trains selected based upon the targeted treatment tissue and surrounding healthy tissue, form adjusting of a delay time between pulses. Avoiding damage to healthy tissue provides for adjustment of delay time during application).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, Cioanta, and Theuer ‘438 to incorporate the selective cancer cell targeted treatment pulses including pause time adjustment based upon measured cell information as taught by Theuer ‘239 because it provides for the specific type of targeted energy to destroy the targeted cells of interest based upon the known physical properties (Theuer ‘239, [0013]) while avoiding damaging healthy surrounding tissues (Theuer ‘239, [0017]).
Claims 8 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239 as applied to claims 1 or 10 above, and further in view of Theuer ‘024, in further view of Reichenberger ‘111
Regarding claim 8, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 1. Primary reference Capelli further fails to teach:
the treatment device includes a plurality of shockwave generators and a plurality of applicators;
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators; and
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
the treatment device includes a plurality of shockwave generators and a plurality of applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder);
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli and Theuer ‘239 to incorporate the positioning of a plurality of applicators relative to one another with pulsed output as taught by Theuer ‘024 because it enables alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space (Theuer ‘024, [0032]).
Primary reference Capelli further fails to teach:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves
However, the analogous art of Reichenberger ‘111 of a shock wave generator for delivering first and second time-staggered waves to a target of interest (abstract) teaches:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves (col 1, lines 32-37, “the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the concrement.”; col 1, lines 65-68, “If the appropriate dimensions are suitably chosen, two secondary shock waves can impinge on the concrement staggered in time in such a way that their actions overlap”; col 2, lines 31-65, right hand part 5a and left wave 5b form the sequentially generated impulses that are configured to have a temporal interval between arrival of the waves at the impulse field that is smaller than the duration of the first arriving impulse. This forms an impulse field with two (a plurality) of overlapping impulses as claimed; As shown in figure 1, reflectors 11 and 13 form at least two of the impulse applicators applying first and second waves to emit the waves in a time-staggered manner to the target location; col 2, line 66 through col 3, line 21 further discuss the time delay of 10 microseconds as an example in which the impulse arrivals are sequential, with the temporal interval between impulses small enough to enable superposition of the wave action at the target tissue region of interest)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, and Theuer ‘024 to incorporate the overlapping destructive impulses at the target region of interest in a time-staggered manner by adjacent applicators as taught by Reichenberger ‘111 because the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the treatment site (Reichenberger ‘111, col 1, lines 32-37). This leads to improved treatment efficiency, leading to better results at a reduced cost.
Regarding claim 21, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further fails to teach:
the treatment device includes a plurality of shockwave generators and a plurality of applicators;
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
the treatment device includes a plurality of shockwave generators and a plurality of applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder);
each one of said shockwave generators has a respective one of said applicators attached thereto for enabling temporally successive ones of said shockwaves to be emitted from different ones of said applicators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli and Theuer ‘239 to incorporate the positioning of a plurality of applicators relative to one another with pulsed output as taught by Theuer ‘024 because it enables alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space (Theuer ‘024, [0032]).
Primary reference Capelli further fails to teach:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves
However, the analogous art of Reichenberger ‘111 of a shock wave generator for delivering first and second time-staggered waves to a target of interest (abstract) teaches:
the current one of said shockwaves is applied by one of said applicators and the immediately prior-applied one of said shockwaves is applied by a different one of said applicators than applied the current one of said shockwaves (col 1, lines 32-37, “the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the concrement.”; col 1, lines 65-68, “If the appropriate dimensions are suitably chosen, two secondary shock waves can impinge on the concrement staggered in time in such a way that their actions overlap”; col 2, lines 31-65, right hand part 5a and left wave 5b form the sequentially generated impulses that are configured to have a temporal interval between arrival of the waves at the impulse field that is smaller than the duration of the first arriving impulse. This forms an impulse field with two (a plurality) of overlapping impulses as claimed; As shown in figure 1, reflectors 11 and 13 form at least two of the impulse applicators applying first and second waves to emit the waves in a time-staggered manner to the target location; col 2, line 66 through col 3, line 21 further discuss the time delay of 10 microseconds as an example in which the impulse arrivals are sequential, with the temporal interval between impulses small enough to enable superposition of the wave action at the target tissue region of interest)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239 and Theuer ‘024 to incorporate the overlapping destructive impulses at the target region of interest in a time-staggered manner by adjacent applicators as taught by Reichenberger ‘111 because the effect of the shock waves can be improved if they are so closely spaced in time that they overlap in their action on the treatment site (Reichenberger ‘111, col 1, lines 32-37). This leads to improved treatment efficiency, leading to better results at a reduced cost.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239, in view of Theuer ‘024, in further view of Reichenberger ‘111 as applied to claim 8 above, and further in view of Theuer ‘438.
Regarding claim 9, the combined references of Capelli, Theuer ‘239, Theuer ‘024, and Reichenberger ‘111 teach all of the limitations of claim 8. Primary reference Capelli further fails to teach:
wherein at least one of: the target volume is pre-heated to between about 39 °C and about 41 °C before application of said shockwaves to increase sensitivity of said malignant cells to said shockwaves; and
However, the analogous art of Theuer ‘438 of an ultrasonic device used for selective destruction of diseased body cells such as tumors ([0001]; [0004]) teaches:
wherein at least one of: the target volume is pre-heated to between about 39 °C and about 41 °C before application of said shockwaves to increase sensitivity of said malignant cells to said shockwaves ([0041], pre-sonication; [0050]-[0051], the range of 15 °C to 42 °C is within the claimed range. As this is the operable range for treatment, application of shockwaves also occurs after the volume is heated to operable temperature).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, Theuer ‘024, and Reichenberger ‘111 to incorporate the treatment temperature range as taught by Theuer ‘438 because healthy tissue can withstand high levels of sonication without damage which enables selective treatment of targeted cells within the target tissue region (Theuer ‘438, [0012]).
Primary reference Capelli further fails to teach:
the prescribed delay time between at least one instance of said temporally successive shockwaves can be adjusted during said applying
However, the analogous art of Theuer ‘239 of a device for treatment of diseased cells and malignant tissue within the body (abstract) teaches:
the prescribed delay time between at least one instance of said temporally successive shockwaves can be adjusted during said applying ([0013], selective destruction of cells with a certain pathological condition appearance and generated targeted treatment for the respective cell type; [0014], teaches to information related to mechanical attributes of malignant cells; [0015], teaches to cancer cell specific destruction which provides for malignant cells of a tumor; [0016], vibration properties of pathologically altered cells forms reception of information characterizing mechanical attributes; [0017]-[0022] describe frequency configuration and pulse configuration (impulse shape and/or sequences) for optimal destruction of selected cells; [0021]-[0022], pause durations form the delay time between successive tumor destructive impulses and is adjusted based upon the selected cells (see citation above regarding patient-individual treatment parameters); [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; [0043]-[0050]; [0053], cell dependent frequency spectrum; [0054]-[0055], pause durations of pulse trains selected based upon the targeted treatment tissue and surrounding healthy tissue, form adjusting of a delay time between pulses. Avoiding damage to healthy tissue provides for adjustment of delay time during application).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, Theuer ‘024, Reichenberger ‘111, and Theuer ‘438 to incorporate the selective cancer cell targeted treatment pulses including pause time adjustment based upon measured cell information as taught by Theuer ‘239 because it provides for the specific type of targeted energy to destroy the targeted cells of interest based upon the known physical properties (Theuer ‘239, [0013]) while avoiding damaging healthy surrounding tissues (Theuer ‘239, [0017]).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239 as applied to claim 10 above, and further in view of Theuer ‘024.
Regarding claim 11, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further fails to teach:
further comprising: a plurality of positioning mechanisms, wherein the treatment device comprises a plurality of applicators and wherein each of the applicators is attached to a respective one of the positioning mechanisms
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
further comprising: a plurality of positioning mechanisms, wherein the treatment device comprises a plurality of applicators and wherein each of the applicators is attached to a respective one of the positioning mechanisms ([0014], positioning ability of generators; [0021]-[0022], positioning and pivoting of ultrasound generators; [0034], mechanically moveable; [0035], aligned in any position; [0044]-[0045]; figure 1 and figure 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli and Theuer ‘239 to incorporate the mechanically moveable positioning of applicators as taught by Theuer ‘024 because it enables efficient alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space such as a breast tissue region (Theuer ‘024, [0032]; [0044]-[0045]).
Regarding claim 12, the combined references of Capelli, Theuer ‘239, and Theuer ‘024 teach all of the limitations of claim 11. Primary reference Capelli further fails to teach:
further comprising: at least one diagnostic unit having each of the applicators attached thereto, wherein the at least one diagnostic unit provides for at least one of monitoring of treatment parameters and control of the positioning mechanisms
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
further comprising: at least one diagnostic unit having each of the applicators attached thereto, wherein the at least one diagnostic unit provides for at least one of monitoring of treatment parameters and control of the positioning mechanisms ([0014]; [0020]-[0022], control system and positioning system provides for a diagnostic unit with monitoring of treatment parameters and control of positioning mechanisms; [0034]-[0035]; [0039], control system; [0042], activation based upon determined position; [0042], automatic alignment based upon determined position; [0044]-[0045]; figures 1 and 3; see also [0046]-[0050]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, and Theuer ‘024 to incorporate the treatment parameter monitoring and mechanically moveable positioning/monitoring of applicators as taught by Theuer ‘024 because it enables efficient alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space such as a breast tissue region (Theuer ‘024, [0032]; [0044]-[0045]). This improves efficiency of treatment across a treatment session.
Regarding claim 13, the combined references of Capelli, Theuer ‘239, and Theuer ‘024 teach all of the limitations of claim 11. Primary reference Capelli further fails to teach:
wherein each of the applicators is coupled to an anatomically-shaped holding device via a respective one of the positioning mechanisms
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein each of the applicators is coupled to an anatomically-shaped holding device via a respective one of the positioning mechanisms (In the following citations, the treatment bell 10 is anatomically shaped for a breast tissue region; [0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs form successive sequence of impulses; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, and Theuer ‘024 to incorporate the anatomically shaped holder for a portion of a breast as taught by Theuer ‘024 because it enables efficient alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space such as a breast tissue region (Theuer ‘024, [0032]; [0044]-[0045]).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239, in further view of Theuer ‘024 as applied to claim 13 above, and further in view of Quistgaard et al. (U.S. Pub. No. 20050154431) hereinafter Quistgaard.
Regarding claim 14, the combined references of Capelli, Theuer ‘239, and Theuer ‘024 teach all of the limitations of claim 13. Primary reference Capelli further fails to teach:
further comprising: at least one diagnostic unit having each of the applicators attached thereto, wherein the at least one diagnostic unit provides for control of the positioning mechanisms
However, the analogous art of Quistgaard of a therapeutic treatment device for use with an applicator (abstract) teaches:
further comprising: at least one diagnostic unit having each of the applicators attached thereto, wherein the at least one diagnostic unit provides for control of the positioning mechanisms ([0143], position of the energy applicator is provided using micro motor assembly and actuators and controlled by processor units based upon position sensors and desired positions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli, Theuer ‘239, and Theuer ‘024 to incorporate the diagnostic unit for control of positioning mechanism as taught by Quistgaard because it provides for precise placement of the device at regions of interest, leading to improved treatment quality and reduced side effects (Quistgaard, [0143]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239 as applied to claim 10 above, and further in view of Theuer ‘024, in further view of Zhong et al. (U.S. Pub. No. 20030093013) hereinafter Zhong.
Regarding claim 15, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further fails to teach:
the treatment device includes a least two shockwave generators; and
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
the treatment device includes a least two shockwave generators ([0014], holder includes a plurality of the generators and the probes for treatment; [0015]; [0021]-[0022]; [0024], pulsed outputs; [0031]-[0035], treatment bell 10 of figure 1 provides a plurality of applicators spaced apart relative to one another for directing treatment pulses to a common target location; [0039]-[0040]; [0044]-[0045], figure 3, individual probes 30a form spaced-apart impulse applicators within the holder); and
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli and Theuer ‘239 to incorporate the positioning of a plurality of applicators relative to one another with pulsed output as taught by Theuer ‘024 because it enables alignment of treatment beams such that the maximum power of the treatment is focused within the target area of the treatment space (Theuer ‘024, [0032]).
Primary reference Capelli further fails to teach:
each of the shockwave generators generates shockwaves respectively using a different one of a plurality of shockwave generating techniques than each other one of the shockwave generators
However, the analogous art of Zhong of a shockwave generation treatment method and system (abstract) teaches:
each of the shockwave generators generates shockwaves respectively using a different one of a plurality of shockwave generating techniques than each other one of the shockwave generators ([0020], combinations of electrohydraulic, electromagnetic, piezoelectric are utilized in generation of shock waves which teaches to generation of multiple techniques over other shockwave generators).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli and Theuer ‘239 to incorporate the multiple types of shockwave generating techniques as taught by Zhong because it provides it provides interchangeable shock wave generating techniques which provides for greater adaptability in device construction without being reliant on a particular shockwave generation technique (Zhong, [0020]). This provides for more flexibility in both manufacturing and maintenance of devices over time.
Claims 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘239 as applied to claims 1 or 10 above, and further in view of Klopotek et al. (U.S. Pub. No. 20080027328) hereinafter Klopotek.
Regarding claim 22, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 1. Primary reference Capelli further fails to teach:
wherein a first impulse of adjacently-applied ones of said shockwaves predominantly contains a negative-pressure component of said shockwaves for maximizing shear forces applied to a cell membrane of said malignant cells by said shockwaves
However, the analogous art of Klopotek of an acoustic tissue treatment device and method (abstract) teaches:
wherein a first impulse of adjacently-applied ones of said shockwaves predominantly contains a negative-pressure component of said shockwaves for maximizing shear forces applied to a cell membrane of said malignant cells by said shockwaves ([0017]-[0019], negative pressure within the treatment wave which applies strong mechanical tissue disrupting pressure waves (maximizing of shear forces equivalency); [0112]-[0113], negative pressure wave; [0132], maximum the application of negative pressure to the target tissue; [0133], high degree of tensile force and stress on the target tissue of interest).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli and Theuer ‘239 to incorporate the negative pressure shockwaves for maximizing stress on the target tissue as taught by Klopotek because enhancing negative pressure or "cavitation" effects, whereby a high degree of tensile force is experienced by the target tissue leads to improved treatment efficacy (Klopotek, [0133]).
Regarding claim 23, the combined references of Capelli and Theuer ‘239 teach all of the limitations of claim 10. Primary reference Capelli further fails to teach:
wherein a first impulse of adjacently-applied ones of said shockwaves predominantly contains a negative-pressure component of said shockwaves for maximizing shear forces applied to a cell membrane of said malignant cells by said shockwaves
wherein a first impulse of adjacently-applied ones of said shockwaves predominantly contains a negative-pressure component of said shockwaves for maximizing shear forces applied to a cell membrane of said malignant cells by said shockwaves ([0017]-[0019], negative pressure within the treatment wave which applies strong mechanical tissue disrupting pressure waves (maximizing of shear forces equivalency); [0112]-[0113], negative pressure wave; [0132], maximum the application of negative pressure to the target tissue; [0133], high degree of tensile force and stress on the target tissue of interest).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the impulse tumor treatment device of Capelli and Theuer ‘239 to incorporate the negative pressure shockwaves for maximizing stress on the target tissue as taught by Klopotek because enhancing negative pressure or "cavitation" effects, whereby a high degree of tensile force is experienced by the target tissue leads to improved treatment efficacy (Klopotek, [0133]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Slayton et al. (U.S. Pub. No. 20110178444) teaches to a method and system for generating thermal energy at target regions of interest for ultrasound imaging and therapy. The reference teaches to customization of parameters for treatment of a particular region of interest.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN A FRITH whose telephone number is (571)272-1292. The examiner can normally be reached M-Th 8:00-5:30 Second Fri 8:00-4:30.
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/SEAN A FRITH/Primary Examiner, Art Unit 3798
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