mDetailed 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) submitted on 08/20/2026 has been considered by the examiner.
Response to Amendment
The amendment filed 08/20/2026 has been entered. Claims 1-47 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 05/28/2026.
Response to Arguments
Applicant's arguments filed 08/20/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “The recited "discharge frequency distribution" is the spectral content of a single capacitor discharge, being "the frequency distribution in the Fourier-transformed pressure curve of the shock wave that has left the applicator."” (see pg. 12, para. 1 of applicant’s remarks) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For claim 7, the applicant argues “An "energy rise time" is not a pressure-front rise time…” (see pg. 13, para. 1), and the examiner disagrees. Under broadest reasonable interpretation, energy rise time is the same as pressure-front rise time. Therefore, Herekar teaches claim 7.
For claim 10, the applicant argues “Herekar's fixed reflector does not disclose focusing and defocusing "by shifting a position of at least one of the electrodes in the reflector" as recited by claim 10.” (see pg. 14, para. 2), and the examiner disagrees. Herekar teaches focusing and defocusing by shifting electrodes in the reflector (see para. 0379 – “Alternatively, or in combination, one or more reflectors may be coupled to an internal surface of the fluid-filled chamber 106 in order to focus the shockwaves. The one or more reflectors may, for example, comprise an electronically variable acoustic lens 7304, which may enable variable or adjustable focusing of the shockwaves along the z-plane on the crystalline lens 2302 (or IOL) and/or the macular of the retina 2208.”).
For claim 12, the applicant argues “Sequential energizing does not disclose applicators "directed at a brain region from different directions." Herekar is directed to eye treatment and does not teach directing applicators at a brain region.” (see pg. 14, para. 3), and the examiner disagrees. Herekar teaches directing applicators at a brain region (see para. 0148 – “The present disclosure is described in relation to deployment of systems, devices, or methods for treatment of an eye of a patient. However, one of skill in the art will appreciate that this is not intended to be limiting and the devices and methods disclosed herein may be used in other anatomical areas and in other surgical procedures.”).
For claim 14, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “The specification describes auto ignition as a switch-less ignition mechanism in which "the electrode gap is set so that discharge is possible without switching from a certain capacitor voltage."” (see pg. 14, para. 4)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For claim 19, the applicant argues “Herekar's ultrasound imaging system is a diagnostic imaging device, not a therapeutic arrangement "adapted to apply ultrasound and shock waves to a same treatment area" as recited by claim 19.” (see pg. 14, para. 5), and the examiner disagrees. Herekar teaches imaging and treating the same area (see para. 0365 – “The imaging system 6706 may be used to capture one or more images of the eye before, during, or after treatment as described herein. A processor or controller may be coupled to the energy source and the imaging system and be configured with instructions to deliver energy to the shockwave generators and image the tissue during treatment.").
For claim 21, the applicant argues “Herekar's temperature sensors sense chamber fluid temperature for intraoperative shockwave amplitude and focusing adjustment; they do not constitute "a temperature control device for a patient's head" as recited by claim 21.” (see pg. 15, para. 1), and the examiner disagrees. Herekar teaches a temperature control device for a patient’s head (see para. 0148 – “The present disclosure is described in relation to deployment of systems, devices, or methods for treatment of an eye of a patient. However, one of skill in the art will appreciate that this is not intended to be limiting and the devices and methods disclosed herein may be used in other anatomical areas and in other surgical procedures.”; see para. 0175 – “Temperature, sono-cavitational (i.e., bubble-making) efficiency, and/or fluid pressure sensors may be disposed within the shockwave-generating flow chamber (also referred to herein as a fluid-filled chamber) and may be used for intraoperative shockwave amplitude and focusing adjustment. The one or more sensors may be employed to provide for uniform, stable delivery of the shockwaves during treatment.”).
For claims 3-4 and 33-36, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “The specification teaches that to significantly reduce the discharge frequency, "this inductance of the discharge circuit must be massively increased, e.g. to about twice, preferably about three times, even more preferably about four times, even more preferably about five times this inductance."” (see pg. 16, para. 2)) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 7-12, 14-17, 19-21, 26-31, 37-41, and 45-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herekar et al. (US 20220287878 A1, published September 15, 2022), hereinafter referred to as Herekar.
Regarding claim 1, Herekar teaches a device for extracorporeal shock wave therapy, comprising:
at least one shock wave generator (Fig. 1; see para. 0174 "The gap114 between the first and second electrodes 110, 112 [generator] may be sufficient to generate a shockwave using a current of about 50 amperes.");
at least one shock wave applicator connected to the at least one shock wave generator (Fig. 1; see para. 0153 "The shockwave generator 100 may comprise a first electrode 110 and a second electrode 112 [generator] disposed within [connected to] housing 102 [applicator]."); and
a capacitor discharge resonant circuit having a discharge frequency distribution that has a maximum which is below 350 kHz (see para. 0188 "In some embodiments, the shockwave generator100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50Hz, 100 Hz, 200Hz, 300Hz,400 Hz, 500Hz,600 Hz, 700Hz,800 Hz, 900 Hz, 1kHz, 10kHz, 20kHz, 30kHz, 40kHz, or 50kHz [max distribution frequency below350kHz]."; Fig. 72, treatment system 7200 as capacitor discharge resonant circuit; see para. 0378 "The HVPS unit may, for example, be configured to deliver around 125 Watts to the capacitor. The capacitor may be rapidly (about 1 μsec) discharged by the high voltage switch HVSW into a saline container. ").
Furthermore, regarding claim 2, Herekar further teaches a frequency controller configured to adjust the shock wave generator so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 350kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200Hz, 300 Hz, 400 Hz, 500 Hz, 600 Hz, 700 Hz, 800Hz, 900Hz, 1kHz, 10kHz, 20kHz, 30kHz, 40kHz, or 50kHz[max frequency distribution below 350 kHz].").
Regarding claim 7, Herekar teaches a device for extracorporeal shock wave therapy, comprising:
at least one shock wave generator (Fig. 1; see para. 0174 "The gap114 between the first and second electrodes 110, 112 [generator] may be sufficient to generate a shockwave using a current of about 50 amperes.");
at least one shock wave applicator (Fig. 1; see para. 0153 "The shockwave generator100may comprise a first electrode 110 and a second electrode 112 [generator] disposed within [connected to] housing 102 [applicator].");
a capacitor discharge resonant circuit having a discharge frequency distribution that has a maximum which is below 350 kHz (see para. 0188 "In some embodiments, the shockwave generator100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50Hz, 100 Hz, 200Hz, 300Hz,400 Hz, 500Hz,600 Hz, 700Hz,800 Hz, 900 Hz, 1kHz, 10kHz, 20kHz, 30kHz, 40kHz, or 50kHz [max distribution frequency below350kHz]."; Fig. 72, treatment system7200ascapacitordischarge resonant circuit; see para. 0378 "The HVPS unit may, for example, be configured to deliver around 125 Watts to the capacitor. The capacitor may be rapidly (about 1 μsec) discharged by the high voltage switch HVSW into a saline container. ").; and
a pulse controller configured to adjust the shock wave generator such that a shock wave leaving the shock wave applicator has a rise time of 6-40ns, the rise time being a period in which a pressure amplitude of the shock wave rises from 10% of a maximum pressure value to 90% of the maximum pressure value (see para. 0186 "In some embodiments, the shockwave generator 100 may be configured to deliver shockwaves with an energy rise time within a range of about 10 nsec to about 100 μsec.").
Furthermore, regarding claim 8, Herekar further teaches wherein the pulse controller is designed to adjust the rise time by at least one of a) changing an inductance of a capacitor discharge resonant circuit or b) changing a setting of a discharge voltage (Fig. 18; see para. 0231 "The power source 1802 may comprise a high voltage pulse generator. In some embodiments, the power source 1802 may comprise a high voltage capacitor charging power supply. Gated high voltage electronics drivers maybe coupled to the shockwave generator(s) 100 and may be able to control the driving voltage of the electrodes responsive to safety feedback mechanisms such as maximum current (e.g., as sensed with a current sensor as described herein), dwell time to current start, temperature rise (e.g., of the electrodes, of the fluid, or at the surface of the eye), peak pressure, and/or elasticity changes.").
Regarding claim 9, Herekar teaches adevice for extracorporeal shock wave therapy, comprising:
at least one electrohydraulic shock wave generator see para. 0044 "In some embodiments, the plurality of shockwave generators may comprise a plurality of electrohydraulic… shockwave generators."; Fig. 1; see para. 0174 "The gap114 between the first and second electrodes 110, 112 [generator] may be sufficient to generate a shockwave using a current of about 50 amperes.");
at least one shock wave applicator (Fig. 1; see para. 0153 "The shockwave generator100may comprise a first electrode 110 and a second electrode 112 [generator] disposed within [connected to] housing 102 [applicator].");
a capacitor discharge resonant circuit having a discharge frequency distribution that has a maximum which is below 350 kHz (see para. 0188 "In some embodiments, the shockwave generator100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50Hz, 100 Hz, 200Hz, 300Hz,400 Hz, 500Hz,600 Hz, 700Hz,800 Hz, 900 Hz, 1kHz, 10kHz, 20kHz, 30kHz, 40kHz, or 50kHz [max distribution frequency below350kHz]."; Fig. 72, treatment system7200ascapacitordischarge resonant circuit; see para. 0378 "The HVPS unit may, for example, be configured to deliver around 125 Watts to the capacitor. The capacitor may be rapidly (about 1 μsec) discharged by the high voltage switch HVSW into a saline container. "); and
a pulse frequency controller that is configured to adjust the at least one electrohydraulic shock wave generator to deliver shock waves with a pulse frequency greater than or equal to 15 Hz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range of about 1 Hz to about 50 KHz...").
Furthermore, regarding claim 10, Herekar further teaches at least one applicator with a reflector and a pair of electrodes, and a controller configured to focus and defocus delivered shock waves by shifting a position of at least one of the electrodes in the reflector (see para. 0223 "Each shockwave generator 100 may comprise a pair of coaxially-aligned electrodes and a reflector as described herein. The reflector may be configured to help focus the shockwave towards a pre-determined location on or under the surface of the eye as described herein.").
Furthermore, regarding claim 11, Herekar further teaches wherein the at least one shock wave applicator comprises two or more shock wave applicators each having a pair of electrodes, and at least one discharge capacitor (Fig. 3; see para. 0195 "In some embodiments, the array300 may comprise eight shockwave generators 100 [more than two shockwave applicators]..."; see para. 0223 "Each shockwave generator 100 may comprise a pair of coaxially-aligned electrodes and a reflector as described herein."; Fig. 72, system 7200 includes a discharge capacitor; see para. 0378 "The HVPS [high voltage power supply] unit may, for example, be configured to deliver around 125 Watts to the capacitor. The capacitor may be rapidly (about 1 μsec) discharged by the high voltage switch HVSW into a saline container.").
Furthermore, regarding claim 12, Herekar further teaches wherein the two or more shock wave applicators are adapted to be directed at a brain region from different directions (Fig. 1, electrodes 110, 112 (two shockwave applicators) directed at region form different directions; see para. 0148 – “The present disclosure is described in relation to deployment of systems, devices, or methods for treatment of an eye of a patient. However, one of skill in the art will appreciate that this is not intended to be limiting and the devices and methods disclosed herein may be used in other anatomical areas and in other surgical procedures.”).
Furthermore, regarding claim 14, Herekar further teaches wherein the device includes auto-ignition (Fig. 81; see para 0409- "Any of the shockwave generators described herein may comprise a passive cavitation detector 8104. During pulsing, the passive cavitation detector8104 may be configured to detect shockwave generation (e.g., "main bang delay" 8108) by a shockwave generator 8102 and cavitation formation and collapse 8110 within the tissue 200.").
Furthermore, regarding claim 15, Herekar further teaches wherein at least one of: A) the capacitor discharge resonant circuit has a capacitor with a capacitance of 50 nF - 400 nF, B) the capacitor discharge resonant circuit has a capacitor with a charging voltage of between 1kV and 20 kV, Application No.: 18/892,777 C) the capacitor discharge resonant circuit has a capacitor and an energy of the shock wave device stored in the capacitor is 0.5J to 25 J, D) the capacitor discharge resonant circuit has an inductance of at least fives times 417 nH, or E) different coaxial high-voltage cables are switchable between the shock wave generator and the shock wave applicator (see para. 0232 "The power supply 1802 may be on the order of about 1 kV to about 10 kV.").
Furthermore, regarding claim 16, Herekar further teaches a system for treating brain tissue or areas of a body, the system comprising the device for extracorporeal shock wave therapy according to claim 1 (see claim 1 above), and
a processor configured thereto, to receive diagnostic data from at least one of a data memory or a diagnostic device (see para. 0234 "The processor may comprise one or more instructions of a treatment program embodied on a tangible medium such as a computer memory or a gate array in order to execute one or more steps of a treatment method as disclosed herein. "),
determine setting parameters for the device for extracorporeal shock wave therapy depending on the diagnostic data, and send the setting parameters to the device for extracorporeal shock wave therapy (see para. 0235 "The processor maybe operatively coupled to the energy source and configured with instructions to deliver energy to the shockwave generator(s) with the treatment parameters described herein. For example, the processor may be configured with instructions to provide a plurality of shockwaves to a pre-determined location on or below a surface of the eye with a desired treatment pattern and parameters.").
Furthermore, regarding claim 17, Herekar further teaches wherein the setting parameters are selected from the group consisting of: a number, position and/or orientation of the at least one shock wave applicator, a discharge frequency of the capacitor discharge resonant circuit, a rise time of the shock wave, a power level or charging voltage of a capacitor of the capacitor discharge resonant circuit, a degree of focus, a pulse frequency, a number of shock waves to be applied, sequences of individual shock waves, and a repetition rate of pulse sequences (see para. 0235 "The processor may be operatively coupled to the energy source and configured with instructions to deliver energy to the shockwave generator(s) with the treatment parameters described herein.").
Furthermore, regarding claim 19, Herekar further teaches an ultrasound device and a combination control arrangement adapted to apply ultrasound and shock waves to a same treatment area (Fig. 67; see para. 0365 "The imaging system 6706 may comprise an ultrasound biomicroscopy (UBM), ultrasound (US) imaging.. The imaging system 6706 may be used to capture one or more images of the eye before, during, or after treatment as described herein. A processor or controller may be coupled to the energy source and the imaging system and be configured with instructions to deliver energy to the shockwave generators and image the tissue during treatment.").
Furthermore, regarding claim 20, Herekar further teaches a medicine delivery device and the processor is further configured thereto, to determine dispensing parameters for the medicine delivery device depending on the diagnostic data, and to transfer the dispensing parameters to the medicine delivery device (Fig. 79; see para. 0393 "In some embodiments, a reservoir 7904 of oxygen and/or one or more therapeutic substances may disposed be on or under the eye-contacting surface 104 for drug delivery to the cornea 2206. The reservoir 7904 may be coupled to the eye 200 with a vacuum sealed fixation ring 1202. Shockwaves generated by the shockwave generator may enhance drug delivery to the cornea 2206 (e.g., to the epithelium) by causing surface fragmentation and/or micro-poration of the corneal tissue of interest to improve drug permeability.").
Furthermore, regarding claim 21, Herekar further teaches wherein the apparatus comprises a temperature control device for a patient's head and the processor is further configured thereto, to determine temperature control parameters for the temperature control device as a function of the diagnostic data, and to transfer the temperature control parameters to the temperature control device (see para. 0175 "Temperature, sono-cavitational (i.e., bubble-making) efficiency, and/or fluid pressure sensors may be disposed within the shockwave-generating flow chamber (also referred to herein as a fluid-filled chamber) and may be used for intraoperative shockwave amplitude and focusing adjustment.").
Furthermore, regarding claim 26, Herekar further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 300 kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200 Hz, 300 Hz,400Hz, 500 Hz, 600 Hz, 700 Hz, 800Hz, 900 Hz, 1kHz, 10 kHz, 20 kHz, 30 kHz, 40kHz, or 50 kHz [max distribution frequency below 300 kHz].").
Furthermore, regarding claim 27, Herekar further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 250 kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200 Hz, 300 Hz, 400Hz, 500 Hz, 600Hz, 700 Hz, 800Hz, 900 Hz, 1kHz, 10 kHz, 20 kHz, 30 kHz, 40kHz, or 50 kHz [max distribution frequency below 250 kHz].").
Furthermore, regarding claim 28, Herekar further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 200 kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200Hz, 300 Hz, 400Hz, 500 Hz, 600Hz, 700 Hz, 800 Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz, 40 kHz, or 50 kHz [max distribution frequency below 200 kHz].").
Furthermore, regarding claim 29, Herekar further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 150 kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200Hz, 300 Hz,400Hz, 500 Hz, 600Hz, 700 Hz, 800Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz,40kHz, or 50 kHz [max distribution frequency below 150 kHz].").
Furthermore, regarding claim 30, Herekar further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 100 kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200Hz, 300 Hz, 400Hz, 500 Hz, 600Hz, 700 Hz, 800 Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz, 40kHz, or 50 kHz [max distribution frequency below 100 kHz].").
Furthermore, regarding claim 31, Herekar further teaches wherein the at least one shock wave generator is an electrohydraulic shock wave generator (see para. 0044 "In some embodiments, the plurality of shockwave generators may comprise a plurality of electrohydraulic shockwave generators.").
Furthermore, regarding claim 37, Herekar further teaches wherein the frequency controller is configured to adjust the electrohydraulic shock wave generator so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 300kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500 Hz, 600 Hz, 700 Hz, 800Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz, 40 kHz, or 50 kHz [max distribution frequency below 300 kHz].").
Furthermore, regarding claim 38, Herekar further teaches wherein the frequency controller is configured to adjust the electrohydraulic shock wave generator so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 250 kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500 Hz, 600 Hz, 700 Hz, 800Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz, 40 kHz, or 50 kHz [max distribution frequency below 250 kHz].").
Furthermore, regarding claim 39, Herekar further teaches wherein the frequency controller is configured to adjust the electrohydraulic shock wave generator so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 200kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500Hz, 600 Hz, 700 Hz, 800Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz, 40 kHz, or 50 kHz [max distribution frequency below 200 kHz].").
Furthermore, regarding claim 40, Herekar further teaches wherein the frequency controller is configured to adjust the electrohydraulic shock wave generator so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 150kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500Hz, 600 Hz, 700 Hz, 800Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz, 40 kHz, or 50 kHz [max distribution frequency below 150 kHz].").
Furthermore, regarding claim 41, Herekar further teaches wherein the frequency controller is configured to adjust the electrohydraulic shock wave generator so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 100kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200 Hz, 300 Hz, 400 Hz, 500Hz, 600 Hz, 700 Hz, 800Hz, 900 Hz, 1 kHz, 10 kHz, 20 kHz, 30 kHz, 40 kHz, or 50 kHz [max distribution frequency below 100 kHz].").
Furthermore, regarding claim 45, Herekar further teaches wherein the capacitor discharge resonant circuit has a capacitor with a charging voltage of between 1kV and 7.5 kV (Fig. 1; see para. 0173 "The gap114 between the first and second electrodes 110, 112 may be sufficient to generate a shockwave using voltage pulses within a range of about 3 kilovolts (kV) to about 4 kV.").
Furthermore, regarding claim 46, Herekar further teaches wherein the capacitor discharge resonant circuit has a capacitor and an energy of the shock wave device stored in the capacitor is 0.5J to 5 J (see para. 0378 "A programmable 0-2 kV high voltage power supply module HVPS may be configured to deliver power to a capacitor. The HVPS unit may, for example, be configured to deliver around 125 Watts to the capacitor." Where a capacitor inherently has stored energy).
Furthermore, regarding claim 47, Herekar further teaches a frequency controller configured to adjust the shock wave generator so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 350kHz (see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range bounded by any two of the following values: 1 Hz, 5 Hz, 10 Hz, 50 Hz, 100 Hz, 200Hz, 300 Hz, 400 Hz, 500 Hz, 600Hz, 700 Hz, 800Hz, 900Hz, 1kHz, 10kHz, 20kHz, 30 kHz,40kHz, or 50kHz [max distribution frequency below 300 kHz].").
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar in view of Liao et al. (CN 218384600 U, published January 24, 2023), hereinafter referred to as Liao.
Regarding claim 3, Herekar teaches all of the elements disclosed in claim 2 above.
Herekar teaches changing frequency, but does not explicitly teach changing frequency by changing inductance determined by the length of the cable.
Whereas, Liao, in an analogous field of endeavor, teaches wherein the frequency controller is configured to adjust the discharge frequency distribution by changing an inductance of the capacitor discharge resonant circuit, including determining a length of a cable between the shock wave generator and the shock wave applicator (see pg. 6, para. 8 high frequency high voltage power supply to charge the high voltage capacitor, high voltage capacitor is charged by the cable for pulse discharge to the treatment head."; see pg. 5, para-2-3 "The cable of this time is designed by means of coaxial cable, the calculation method of the coaxial cable inductance quantity is as follows: formula (1-1):… wherein I represents the coaxial cable length..." change discharge frequency by changing inductance by changing length of cable).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified changing frequency, as disclosed in Herekar, by changing frequency by changing inductance determined by the length of the cable, as disclosed in Liao. One of ordinary skill in the art would have been motivated to make this modification in order to ensure the inductance of the cable reaches the minimum value, so as to reduce the electric energy loss of the cable, as taught in Liao (see pg. 3, para. 10).
Furthermore, regarding claim 4, Liao further teaches a coaxial high-voltage cable between the shock wave generator and the shock wave applicator, wherein the coaxial high-voltage cable is longer than 1.5 m (see pg. 6, para. 2 "...1.8 m coaxial line..." longer than 1.5 m; see pg. 6, para. 8 " high frequency high voltage power supply to charge the high voltage capacitor, high voltage capacitor is charged by the cable for pulse discharge to the treatment head.").
The motivation for claim 4 was shown previously in claim 3.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Herekar in view of Liao, as applied to claim 4 above, and in further view of Schaden.
Regarding claim 5, Herekar in view of Liao teaches all of the elements disclosed in claim 4 above.
Herekar in view of Liao teaches a cable between the shock wave applicator and the shockwave generator, but does not explicitly teach a coil between the applicator and the generator.
Whereas, Schaden, in an analogous field of endeavor, teaches a toroidal or ring core coil arranged between the shock wave applicator and the shock wave generator to realize an additional inductance, in which a current-carrying conductor of the coaxial high-voltage cable is guided once or several times through an interior of the toroidal ring core coil (Fig. 5 and 6, coil 50 between applicator (exit window 17 of shockwave head 43) and generator (control and power supply 41 of the shock wave heads); see para. 0146 "FIG. 6 is a simplified depiction of the pressure pulse/shockwave generator (shockwave head) having an electromagnetic flat coil 50 as the generating element.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a cable between the shock wave applicator and the shockwave generator, as disclosed in Herekar in view of Liao, by also having a coil between the applicator and the generator, as disclosed in Schaden. One of ordinary skill in the art would have been motivated to make this modification in order generate nearly plane waves, as taught in Schaden (see para. 0057).
Claims 6 and 42-44 are rejected under35 U.S.C. 103asbeingunpatentableover Herekar in view of Capelli et al. (US 20200222068 A1, published July 17, 2020) and Matsumotoet al. (WO 2005094701 A1, published October 13, 2005), hereinafter referred to as Capelli and Matsumoto, respectively.
Regarding claim 6, Herekar teaches all of the elements disclosed in claim 1 above.
Herekar teaches transmitting shockwaves, but does not explicitly teach transmitting shockwaves in a range between 80kHz and 850kHz.
Whereas, Capelli, in an analogous field of endeavor, teaches wherein a shock wave that has left the shock wave applicator has frequency bands in a range between 80kHz and 850kHz, and said frequency bands relate to a frequency distribution in a Fourier transform of a pressure curve of the shock wave (see para. 0090 "In one embodiment, the present shockwave generating systems and apparatuses incorporate the probes depicted in FIGS. 10-12C...is configured to be coupled to a pulse generation system (300) configured to apply voltage pulses to the electrodes at a rate of between 10 Hz and 5 MHz [within 80 kHz and 850 kHz].").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified transmitting shockwaves, as disclosed in Herekar, by transmitting shockwaves in a range between 80kHz and 850kHz, as disclosed in Capelli. One of ordinary skill in the art would have been motivated to make this modification in order to generate high-frequency shock waves while having an improved electrode lifetime, as taught in Capelli (see para. 0059).
Herekar in view of Capelli teaches transmitting shockwaves, but does not explicitly teach generating a pressure curve of the shockwaves vs frequency.
Whereas, Matsumoto, in an analogous field of endeavor, teaches said frequency bands relate to a frequency distribution in a Fourier transform of a pressure curve of the shock wave (see para. 0042 "…analyzes the sound pressure signal (frequency component extraction by frequency filter, Fourier transform such as FFT) Frequency analysis)...").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified transmitting shockwaves, as disclosed in Herekar in view of Capelli, by also generating a pressure curve of the shockwaves vs frequency, as disclosed in Matsumoto. One of ordinary skill in the art would have been motivated to make this modification in order to use the pressure amplitude of the sound pressure signal, the magnitude of Z or pressure, and the frequency component of the sound pressure signal as parameters in the feedback loop, as taught in Matsumoto (see para. 0042).
Furthermore, regarding claim 42, Capelli further teaches wherein the shockwave that has left the shock wave applicator has frequency bands whose dominant maxima are in the range between 80kHz and 850kHz (see para. 0090 "In one embodiment, the present shockwave generating systems and apparatuses incorporate the probes depicted in FIGS. 10-12C. is configured to be coupled to a pulse generation system(300) configured to apply voltage pulses to the electrodes at a rate of between 10 Hz and 5 MHz [within 80 kHz and 850 kHz].").
Furthermore, regarding claim 43, Capelli further teaches wherein the shockwave that has left the shock wave applicator has frequency bands whose dominant maxima are in a range between 80kHz and 450kHz (see para. 0090 "In one embodiment, the present shockwave generating systems and apparatuses incorporate the probes depicted in FIGS. 10-12C is configured to be coupled to a pulse generation system(300) configured to apply voltage pulses to the electrodes at a rate of between 10 Hz and 5 MHz [within 80 kHz and 450 kHz].").
Furthermore, regarding claim 44, Capelli further teaches wherein the shock wave that has left the shock wave applicator has frequency bands whose dominant maxima are in a range between 80kHz and 350kHz (see para. 0090 "In one embodiment, the present shockwave generating systems and apparatuses incorporate the probes depicted in FIGS. 10-12C.. is configured to be coupled to a pulse generation system (300) configured to apply voltage pulses tothe electrodes at a rate of between 10 Hz and 5 MHz [within 80 kHz and 450 kHz]."). The motivation for claims 42-44 was shown previously in claim 6.
Claims 13 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar in view of Schaden et al. (US 20070239080A1, published October 11, 2007), hereinafter referred to as Schaden.
Regarding claim 13, Herekar teaches all of the elements disclosed in claim 1 above, and
Herekar further teaches an arrangement of controllers specifying predetermined setting parameters for at least one of a frequency controller, a pulse controller, or a pulse frequency controller (see para. 0235 "The processor may be operatively coupled to the energy source and configured with instructions to deliver energy to the shockwave generator(s) with the treatment parameters described herein. For example, the processor may be configured with instructions to provide a plurality of shockwaves to a pre-determined location on or below a surface of the eye with a desired treatment pattern and parameters."; see para. 0188 "In some embodiments, the shockwave generator 100 may deliver shockwaves with a repetition rate within a range of about 1 Hz to about 50 KHz...").
Herekar teaches extracorporeal shockwave therapy, but does not explicitly teach shockwave treatment of Alzheimer’s disease.
Whereas, Schaden, in an analogous field of endeavor, teaches adopting an operating mode for the treatment of Alzheimer’s disease (see para. 0030 "The inventive method may include enhancing the stimulation of neuronal cell growth or regeneration by administering an effective exposure of pressure pulses or acoustic shock waves in a pulse or wave pattern to stimulate neuronal cell growth or regeneration for the treatment of neurological disorders related to neurodegeneration, including Parkinson's disease, Alzheimer's disease..."; see para. 0145 "FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shockwave generator (43) (shock wave head) and a control and power supply unit (41) for the shock wave head (43)...").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified extracorporeal shockwave therapy, as disclosed in Herekar, by performing shockwave treatment of Alzheimer’s disease, as disclosed in Schaden. One of ordinary skill in the art would have been motivated to make this modification in order to enhance the stimulation of neuronal cell growth or regeneration after a degenerative condition due to any neurological infections or any other pathological condition, as taught in Schaden (see para. 0030).
Regarding claim 32, Herekar teaches providing the device for extracorporeal shockwave therapy according to claim 1 (see claim 1 above), placing the at least one shock wave applicator on a patient's head, and operating the shockwave generator to apply shock or pressure waves to the patient's head (see para. 0148 – “The present disclosure is described in relation to deployment of systems, devices, or methods for treatment of an eye of a patient. However, one of skill in the art will appreciate that this is not intended to be limiting and the devices and methods disclosed herein may be used in other anatomical areas and in other surgical procedures.”);
and Schaden further teaches treatment of Alzheimer’s disease (see para. 0030 "The inventive method may include enhancing the stimulation of neuronal cell growth or regeneration by administering an effective exposure of pressure pulses or acoustic shock waves in a pulse or wave pattern to stimulate neuronal cell growth or regeneration for the treatment of neurological disorders related to neurodegeneration, including Parkinson's disease, Alzheimer's disease...").
The motivation for claim 32 was shown previously in claim 13.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Herekar in view of Schwarze et al. (US 20080033287 A1, published February 7, 2008), hereinafter referred to as Schwarze.
Regarding claim 18, Herekar teaches all of the elements disclosed in claim 17 above.
Herekar teaches shockwave therapy, but does not explicitly teach simulating propagations of the shock waves.
Whereas, Schwarze, in an analogous field of endeavor, teaches wherein the diagnostic device is an imaging device for 3D representations of a head and the processor is configured to simulate propagations of the shock waves in the head based on the image data and to determine optimized setting parameters as a function of the simulation (Fig. 2; see para. 0026 "The system can also display a simulated treatment if so desired prior to initiating actual treatment. The simulated treatment will display the actual therapeutic volume being displayed with a superimposed representation of the shock wave profile simultaneously displayed. In this way the clinician can readjust any of the treatment parameters prior to actually applying the treatment."; see para. 0031 "In other procedures the treatment volume 100 can be any volume of tissue or bone mass [including head] wherein a treatment is to be viewed and treated, by way of example fractured bones, non unions or any part or whole portion of a body tissue or organ in need of treatment.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified shockwave therapy, as disclosed in Herekar, by also simulating propagations of the shock waves, as disclosed in Schwarze. One of ordinary skill in the art would have been motivated to make this modification in order to have the patient receive a shock wave treatment that is satisfactorily certain of the desired results and is not over treated so as to avoid any unnecessary surrounding tissue hemorrhaging, ensuring a more efficient and therefore better use of such shock wave devices that can non-invasively provide the clinician with a real time prognosis of his patient's condition, as taught in Schwarze (see para. 0026).
Claims 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Herekarin view of Schmitt et al. (US 20260090840A1, publishedApril2, 2026with a priority dateofNovember18, 2022), hereinafter referred to as Schmitt.
Regarding claim 22, Herekar teaches a method for providing setting parameters for a treatment of Alzheimer's disease with the system according to claim 16 (see claim 16 above), and
Herekar further teaches the method comprising the steps of: providing data from a data memory or a diagnostic device (see para. 0234 "The processor may comprise one or more instructions of a treatment program embodied on a tangible medium such as a computer memory or a gate array in order to execute one or more steps of a treatment method as disclosed herein. The processor may comprise instructions to treat a patient in accordance with embodiments described herein.").
Herekar teaches setting parameters for shockwave therapy, but does not explicitly teach using artificial intelligence to set therapy parameters.
Whereas, Schmitt, in an analogous field of endeavor, teaches determining setting parameters for the device or extracorporeal shockwave therapy depending on the data by using artificial intelligence to evaluate said data at least one of before or after one or more treatments, wherein said data comprises at least one of diagnostic data, patient-specific data before and after one or more treatments, simulation calculation data, measurement data or data on established treatment courses and successes (see para. 0098 "In another example, a neural network [artificial intelligence] is used to determine the value(s) of the parameter(s) of the intravascular treatment device 180 from the plaque data 110. In this example, the neural network is trained to predict the value(s) of the parameter(s) from the plaque data 110. The neural network is trained to predict the value(s) of the parameter(s) using training data from historic intravascular plaque procedures. The training data includes plaque data 110 for the historic intravascular plaque procedures, and corresponding value(s) for the parameter(s) of the intravascular treatment device 180 that were used in procedures with successful outcomes.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified setting parameters for shockwave therapy, as disclosed in Herekar, by using artificial intelligence to set therapy parameters, as disclosed in Schmitt. One of ordinary skill in the art would have been motivated to make this modification in order to provide improved techniques for planning and guiding vascular plaque treatment procedures, as taught in Schmitt (see para. 0005).
Furthermore, regarding claim 23, Schmitt further teaches determining setting parameters for at least one of a) an ultrasonic device, b) delivery parameters for a medicine delivery device, or c) temperature control parameters for a temperature control device (see para. 0103 "Instead of using a biomechanical model to determine the number of shock wave pulses to deliver to the vessel 130, a neural network may be used. In this case, the neural network may be trained to predict the number of shock wave pulses to deliver to the vessel 130 from plaque data...").
Furthermore, regarding claim 24, Herekar further teaches implementing the artificial intelligence in an analysis module which receives the data, the analysis module conducting a finite element (FEM) analysis to simulate an influence of the shock waves at a cellular level, and outputting an effective treatment based for the setting parameters of the device for extracorporeal shock wave therapy (see para. 0152 "The shockwaves used in ESWT has been shown to have mechanical and cellular effects on the treated tissues. For example, shockwave treatment can have an analgesic effect on treated tissues. Shockwave treatment has also been shown to stimulate production of growth factors, including eNOS, nNOS, and VEGF, which promote neovascularization and cellular regeneration. Shockwave treatment can also be used to generate free radicals, which can promote cell destruction when desired.").
Furthermore, regarding claim 25, Herekar further teaches a computer program fixed in a tangible medium comprising program code for performing the steps of the method according to claim 22 for execution by the processor (see claim 22 above; see para. 0234 "The processor may comprise one or more instructions of a treatment program embodied on a tangible medium such as a computer memory or a gate array in order to execute one or more steps of a treatment method as disclosed herein.").
The motivation for claim 23 was shown previously in claim 22.
Claims 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Herekar in view of Liao, as applied to claim 4 above, and in further view of Chernenko et al. (US 20030176873 A1, published September 18, 2003), hereinafter referred to as Chernenko.
Regarding claim 33, Herekar in view of Liao teaches all of the elements disclosed in claim 4above.
Herekar in view of Liao teaches a coaxial high voltage cable, but does not explicitly teach the cable is longer than 2 meters.
Whereas, Chernenko, in an analogous field of endeavor, teaches the coaxial high-voltage cable is longer than 2.0 m (see para. 0068 "In practice a coaxial cable was used... If the cable has length 50 m [longer than 2 m] then the pulse duration on the load is about 250 nanoseconds at a capacity Cp=5 nanofarads.").
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a coaxial high voltage cable, as disclosed in Herekar in view of Liao, by having the cable longer than 2 meters, as disclosed in Chernenko. One of ordinary skill in the art would have been motivated to make this modification in order to create a positive wave of voltage and then to discharge this voltage, as taught in Chernenko (see para. 0064).
Furthermore, regarding claim 34, Chernenko further teaches wherein the coaxial high-voltage cable is longer than 3.0 m (see para. 0068 "In practice a coaxial cable was used... If the cable has length 50 m [longer than 3 m] then the pulse duration on the load is about 250 nanoseconds at a capacity Cp=5 nanofarads.").
Furthermore, regarding claim 35, Chernenko further teaches wherein the coaxial high-voltage cable is longer than 5.0 m (see para. 0068 "In practice a coaxial cable was used.. If the cable has length 50 m [longer than 5 m] then the pulse duration on the load is about 250 nanoseconds at a capacity Cp=5 nanofarads.").
Furthermore, regarding claim 36, Chernenko further teaches wherein the coaxial high-voltage cable is longer than 10.0 m (see para. 0068 "In practice a coaxial cable was used.. If the cable has length 50 m [longer than 10 m] then the pulse duration on the load is about 250 nanoseconds at a capacity Cp=5 nanofarads.").
The motivation for claims 34-36 was shown previously in claim 33.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Maxwell et al. (US 20170072225 A1, published March 16, 2017) discloses multiple capacitor sizes in parallel are used to supply energy to the amplifier over different time periods between ˜50 ns to 10 ms. Tuned damping resistors are included in series with each capacitor to prevent resonances from the self-inductance and capacitance between different capacitors. When modeled and designed correctly, the array acts as an energy storage reservoir with an effective impedance less than 0.1 Ω between 100 Hz to greater than 10 MHz frequency.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/N.C./Examiner, Art Unit 3798
/PASCAL M BUI PHO/Supervisory Patent Examiner, Art Unit 3798
