DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/17/2025 has been entered.
Response to Amendment
This action is in response to the remarks filed on 10/07/2025. The amendments filed on 10/07/2025 are entered.
The previous rejections of claims 9, 18-20, 24, and 33 under 35 U.S.C. 112(b) have been withdrawn in light of the applicant’s remarks/amendments.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“an impulse generator” in claim 1.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Capelli et al. (U.S. Pub. No. 20140257144) hereinafter Capelli, in view of Klopotek et al. (U.S. Pub. No. 20080027328) hereinafter Klopotek, in view of Cioanta (U.S. Pub. No. 20160310766) hereinafter Cioanta, in further view of Reichenberger (U.S. Pat. No. 4664111) hereinafter Reichenberger ‘111.
Regarding claim 1, primary reference Capelli teaches:
A device for the treatment of malignant diseases (abstract; [0134], treating tumors or other maladies), the device comprising:
an impulse generator for generating tumor-destructive impulses ([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 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”); The limitation of “impulse generator” has been interpreted under 35 U.S.C. 112(f) to correspond to the structure of an impulse generator types as disclosed in [0136]-[0137], [0150], of the applicant’s specification, and includes electrohydraulic pulse generation. This corresponds to the pulse generation system 26 and spark head module 22 as taught by Capelli in [0071], which corresponds to an electrohydraulic (EH) pulse generator), and
Primary reference Capelli fails to teach:
Wherein each tumor-destructive impulse exhibits a plurality of frequency bands
However, the analogous art of Klopotek of a method and apparatus for delivering treatment energy to a tissue region of interest (abstract) teaches:
Wherein each tumor-destructive impulse exhibits a plurality of frequency bands ([0163], shock wave generators that generate pulses with a broad frequency domain forms a teaching to a “plurality of frequency bands” because a broad set of frequencies covers the broadest reasonable interpretation of a plurality of individual bands within the overall set; see also [0130]-[0131])
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 to incorporate the broad frequency domain for shock wave pulse as taught by Klopotek because pulsed broad frequency shock waves provide for powerful mechanical tissue responses leading to enough energy to tear apart tissues and stimulate a biological response (Klopotek, [0130]-[0131]; [0163]). This leads to better treatment efficiency, leading to improved clinical outcomes.
Primary reference Capelli further fails to teach:
a control unit configured to control said generating to cause said tumor-destructive impulses to exhibit a pressure shock repetition frequency of 0.2-30 Hz and an energy flux density of 0.1 to 10 mJ/mm2
However, the analogous art of Cioanta of an acoustic pressure shock wave treatment system (abstract) teaches:
a control unit configured to control said generating to cause said tumor-destructive impulses to exhibit a pressure shock repetition frequency of 0.2-30 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]) and
an energy flux density of 0.1 to 10 mJ/mm2 ([0106], flux density of 0.1 to 1 mJ/mm2 overlaps the claimed range; [0114], flux density; [0120]-[0129], flux density overlaps the claimed range).
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 Klopotek to incorporate the shock repetition frequency and flux density 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.
Primary reference Capelli further fails to teach:
wherein the control unit being configured to control said generating includes the control unit being configured to cause the tumor-destructive impulses to be generated in a sequential manner and to cause a temporal interval between adjacent ones of the tumor-destructive impulses to be smaller than a duration of each of the tumor-destructive impulse such that an impulse field exhibiting a plurality of overlapping tumor-destructive impulses is produced
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:
wherein the control unit being configured to control said generating includes the control unit being configured to cause the destructive impulses to be generated in a sequential manner and to cause a temporal interval between adjacent ones of the destructive impulses to be smaller than a duration of each of the destructive impulse such that an impulse field exhibiting a plurality of overlapping destructive impulses is produced (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; 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, Klopotek, and Cioanta to incorporate the overlapping destructive impulses at the target region of interest by keeping a temporal interval between wave arrivals at a small enough period 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.
Claims 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Klopotek, in view of Cioanta, in further view of Reichenberger ‘111 as applied to claim 1 above, and further in view of Theuer (DE 44 14 239 A1) hereinafter Theuer ‘239 (see attached combined English translation of the office action of 6/18/2025 for citations).
Regarding claim 2, the combined references of Capelli, Klopotek, Cioanta, and Reichenberger ‘111 teach all of the limitations of claim 1. Primary reference Capelli further fails to teach:
wherein:
the control unit is further configured to receive information characterizing mechanical attributes of malignant cells of a tumor associated with the disease; and
the control unit being configured to control said generating includes the control unit being configured to cause the impulse generator to generate said tumor-destructive impulses as a function of said information characterizing mechanical attributes of malignant cells
However, the analogous art of Theuer ‘239 of a device for treatment of diseased cells and malignant tissue within the body (abstract) teaches:
wherein:
the control unit is further configured to receive information characterizing mechanical attributes of malignant cells of a tumor associated with the disease ([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; [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; see also [0043]-[0050]; [0053], cell dependent treatment configurations; [0054]); and
the control unit being configured to control said generating includes the control unit being configured to cause the impulse generator to generate said tumor-destructive impulses as a function of said information characterizing mechanical attributes of malignant cells ([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; [0027]; [0035]-[0039] further describe the cellular biology based parameters utilized to determine optimal stimulation to provide destruction of tumor cells; see also [0043]-[0050]; [0053], cell dependent treatment configurations; [0054])
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, Klopotek, Cioanta, and Reichenberger ‘111 to incorporate the selective cancer cell targeted treatment pulses 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 14, the combined references of Capelli, Klopotek, Cioanta, and Reichenberger ‘111 teach all of the limitations of claim 1. Primary reference Capelli further fails to teach:
wherein said information characterizing mechanical attributes of malignant cells includes information characterizing viscoelasticity of said malignant cells
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 information characterizing mechanical attributes of malignant cells includes information characterizing viscoelasticity of said malignant cells ([0016], viscoelastic behavior of the cell is taken into account; [0031], visco-elastic deformation behavior of a cell; [0036]-[0037], viscosity of the malignant cells; [0044]-[0046]; [0047], visco-elastic behavior; [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, Klopotek, Cioanta, and Reichenberger ‘111 to incorporate the selective cancer cell targeted treatment pulses based upon measured cell information of viscoelasticity 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 different viscoelastic physical properties (Theuer ‘239, [0013]) while avoiding damaging healthy surrounding tissues (Theuer ‘239, [0017]).
Claims 4-13 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Klopotek, in view of Cioanta, in further view of Reichenberger ‘111 as applied to claim 1 above, and further in view of Theuer (U.S. Pub. No. 20120109024) hereinafter Theuer ‘024.
Regarding claim 4, the combined references of Capelli, Klopotek, Cioanta, and Reichenberger ‘111 teach all of the limitations of claim 1. Primary reference Capelli further fails to teach:
further comprising
a plurality of tumor-destructive impulse applicators connected to the impulse generator, wherein the tumor-destructive impulse applicators are in a spaced-apart arrangement relative to each other and are positioned to direct tumor-destructive impulses emitted respectively therefrom to a common target location;
wherein the control unit being configured to control said generating includes the control unit being configured to cause at least two of the tumor-destructive impulse applicators to emit said tumor-destructive impulses respectively therefrom in a successive sequence
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
further comprising
a plurality of tumor-destructive impulse applicators connected to the impulse generator wherein the tumor-destructive impulse applicators are in a spaced-apart arrangement relative to each other and are positioned to direct tumor-destructive impulses emitted respectively therefrom to a common target location ([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);
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, Klopotek, Cioanta, and Reichenberger ‘111 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:
wherein the control unit being configured to control said generating includes the control unit being configured to cause at least two of the tumor-destructive impulse applicators to emit respective instances of said tumor-destructive impulses therefrom in a time-staggered manner with respect to each adjacent one of the tumor-destructive impulse applicators
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:
wherein the control unit being configured to control said generating includes the control unit being configured to cause at least two of the destructive impulse applicators to emit respective instances of said destructive impulses therefrom in a time-staggered manner with respect to each adjacent one of the destructive impulse applicators (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, Klopotek, Cioanta, and Reichenberger ‘111 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 5, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 4. Primary reference Capelli further fails to teach:
further comprising:
an applicator holder having each of the tumor-destructive impulse applicators attached thereto
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
further comprising:
an applicator holder having each of the tumor-destructive impulse applicators attached thereto ([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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 to incorporate the positioning within an applicator holder 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 (Theuer ‘024, [0032]).
Regarding claim 6, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 5. Primary reference Capelli further fails to teach:
wherein the applicator holder is arcuate shaped
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein the applicator holder is arcuate shaped (In the following citations, the treatment bell 10 is arcuate shaped; [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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 to incorporate the arcuate applicator holder 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 7, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 6. Primary reference Capelli further fails to teach:
wherein at least two of the tumor-destructive impulse applicators are in opposing arrangement relative to each other
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein at least two of the tumor-destructive impulse applicators are in opposing arrangement relative to each other (In the following citations, the treatment bell 10 is constructed with at least two of the applicators in opposing arrangement relative to each other; [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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 to incorporate the arcuate applicator holder with opposing applicators to each other 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 8, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 5. Primary reference Capelli further fails to teach:
further comprising:
a plurality of positioning mechanisms each attached to a respective one of the tumor- destructive impulse applicators to enable each of the tumor-destructive impulse applicators to be adjustably arranged relative to a common target location
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 each attached to a respective one of the tumor- destructive impulse applicators to enable each of the tumor-destructive impulse applicators to be adjustably arranged relative to a common target location ([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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 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 9, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 5. Primary reference Capelli further fails to teach:
wherein:
the applicator holder is anatomically shaped;
the applicator holder being anatomically shaped includes the applicator holder having an interior space; and
the interior space being shaped to receive therein a portion of a breast or a portion of a skull
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein:
the applicator holder is anatomically shaped (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);
the applicator holder being anatomically shaped includes the applicator holder having an interior space (In the following citations, the treatment bell 10 is anatomically shaped with an interior space 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); and
the interior space being shaped to receive therein a portion of a breast or a portion of a skull (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, Klopotek, Cioanta, Reichenberger ‘111 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]).
Regarding claim 10, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 4. Primary reference Capelli further fails to teach:
wherein the plurality of tumor-destructive impulse applicators includes at least one pair of tumor-destructive impulse applicators in opposing arrangement relative to each other
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein the plurality of tumor-destructive impulse applicators includes at least one pair of tumor-destructive impulse applicators in opposing arrangement relative to each other (In the following citations, the treatment bell 10 is constructed with at least two of the applicators in opposing arrangement relative to each other; [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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 to incorporate the arcuate applicator holder with opposing applicators to each other 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 11, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 10. Primary reference Capelli further fails to teach:
wherein a common target location of each of the tumor- destructive impulse applicators of the pair is centrally located between the at least one pair of tumor-destructive impulse applicators
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein a common target location of each of the tumor- destructive impulse applicators of the pair is centrally located between the at least one pair of tumor-destructive impulse applicators (In the following citations, the treatment bell 10 is anatomically shaped for a breast tissue region centrally located between the applicators; [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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 to incorporate the arcuate applicator holder with centrally located target region 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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 10. Primary reference Capelli further fails to teach:
wherein: the plurality of tumor-destructive impulse applicators includes at least two sets of opposing tumor-destructive impulse applicators
each of the tumor-destructive impulse applicators is uniformly spaced away from each adjacent one of the tumor-destructive impulse applicators
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein: the plurality of tumor-destructive impulse applicators includes at least two sets of opposing tumor-destructive impulse applicators (In the following citations, the treatment bell 10 is constructed with at least two of the applicators in opposing arrangement relative to each other; [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); and
each of the tumor-destructive impulse applicators is uniformly spaced away from each adjacent one of the tumor-destructive impulse applicators (In the following citations, the treatment bell 10 is constructed with at least two of the applicators in opposing arrangement relative to each other and equally spaced around the treatment bell 10; [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 C Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 to incorporate the arcuate applicator holder with uniformly spaced, opposing applicators to each other 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 13, the combined references of Capelli, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 teach all of the limitations of claim 4. Primary reference Capelli further fails to teach:
wherein at least one of: a common target location of each of the tumor-destructive impulse applicators is centrally located between the tumor-destructive impulse applicators
each of the tumor-destructive impulse applicators is uniformly spaced away from each adjacent one of the tumor-destructive impulse applicators
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
wherein at least one of: a common target location of each of the tumor-destructive impulse applicators is centrally located between the tumor-destructive impulse applicators (In the following citations, the treatment bell 10 is anatomically shaped for a breast tissue region centrally located between the applicators; [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); and
each of the tumor-destructive impulse applicators is uniformly spaced away from each adjacent one of the tumor-destructive impulse applicators (In the following citations, the treatment bell 10 is constructed with at least two of the applicators in opposing arrangement relative to each other and equally spaced around the treatment bell 10; [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, Klopotek, Cioanta, Reichenberger ‘111 and Theuer ‘024 to incorporate the arcuate applicator holder with uniformly spaced, opposing applicators relative to the centrally located target region 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]).
Claims 15-23, 26, 29-33, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Capelli, in view of Theuer ‘024, in further view of Reichenberger ‘111.
Regarding claim 15, primary reference Capelli teaches:
A device for the treatment of diseases (abstract), comprising
at least one shock wave generator ([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”););
a shock wave 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”);)
Primary reference Capelli further fails to teach:
a plurality of shock wave applicators in a spaced-apart arrangement relative to each other and positioned to direct shock waves emitted respectively therefrom to a common target location; and
However, the analogous art of Theuer ‘024 of a tumor cell destruction system using high frequency impulses (abstract) teaches:
a plurality of pulse applicators in a spaced-apart arrangement relative to each other and positioned to direct pulse waves emitted respectively therefrom to a common target location ([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);
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 positioning of a plurality of applicators spaced apart relative to one another 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:
a control unit configured to activate the at least one shock wave generator and wherein the control unit being configured to activate the at least one shock wave generator includes the control unit being configured to cause at least two of the shock wave applicators to emit respective instances of said shock waves therefrom in a time-staggered manner and to cause a temporal interval between adjacent ones of the shock waves to be smaller than a duration of each of the shock waves such that an impulse field exhibiting a plurality of overlapping shock waves is produced
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:
a control unit configured to activate the at least one shock wave generator and wherein the control unit being configured to activate the at least one shock wave generator includes the control unit being configured to cause at least two of the shock wave applicators to emit respective instances of said shock waves therefrom in a time-staggered manner and to cause a temporal interval between adjacent ones of the shock waves to be smaller than a duration of each of the shock waves such that an impulse field exhibiting a plurality of overlapping shock waves is produced (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 and Theuer ‘024 to incorporate the overlapping destructive impulses at the target region of interest by keeping a temporal interval between wave arrivals at a small enough period 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 16, the combined references of Capelli, Theuer ‘024, and Reichenberger ‘111 teach all of the limitations of claim 15. Primary reference Capelli further fails to teach:
further comprising: an applicator holder having each of the sh