Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/23/2024 has been considered by the examiner.
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: “frequency control unit” in claim 2, “pulse control unit” in claim 7, “focus control unit” in claim 10, “control arrangement” and “pulse frequency control unit” in claim 13, and “processor unit” in claim 16.
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. The control device 11 may comprise a frequency control unit, a pulse control unit, a pulse frequency control unit, a focus control unit and/or a control arrangement (Fig. 1; see para. 0206).
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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22 and 37-41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 22, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the purpose of advancing prosecution, the examiner assumes “patient-specific data (e.g., CT or MRI data)” should be “patient-specific data of CT or MRI data”, and “measurement data (e.g., blood measurements)” should be “measurement data of blood measurements” for clarity.
Claims 37-41 recites the limitation "the electrohydraulic shock wave generator". There is insufficient antecedent basis for this limitation in the claim. For the purpose of advancing prosecution, the examiner assumes claims 37-41 should be dependent of claim 31, which recites “an electrohydraulic shock wave generator”.
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 1-3, 6-9, 13-14, 16-18, 22-23, 25-30, 32, and 42-44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Konofagou et al. (US 20180140871 A1, published May 24, 2018), hereinafter referred to as Konofagou.
Regarding claim 1, and similarly for claims 7 and 9, Konofagou teaches a device for extracorporeal shock wave therapy (Fig. 2), comprising:
at least one shock wave generator (Fig. 2, function generator as shock wave generator);
at least one shock wave applicator (3) connected to the at least one shock wave generator (Fig. 2, ultrasound transducer 112 (shock wave applicator) connected to function generator (shock wave generator)); and
a capacitor discharge resonant circuit having a discharge frequency distribution that has a maximum which is below 350 kHz (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art [including rise time of shockwave leaving shock wave applicator]…”; see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz [discharge frequency distribution].”).
Furthermore, regarding claim 2, and similarly for claim 8, Konofagou further teaches a frequency control unit (11) configured to adjust the shock wave generator (12) so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 350kHz (see para. 0037 – “… the neuronavigation system 120 [frequency control unit] can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”).
Furthermore, regarding claim 3, Konofagou further teaches wherein the frequency control unit (11) is configured to adjust the discharge frequency distribution by changing an inductance of the discharge circuit, including determining a length of a cable between the shock wave generator (12) and the shock wave applicator (3) (see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…” where determining inductance of a cable by using the length of the cable as a parameter is a known equation in the art).
Furthermore, regarding claim 6, Konofagou further teaches wherein a shock wave that has left the shock wave applicator (3) 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. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”).
Furthermore, regarding claim 13, Konofagou further teaches a control arrangement that is configured to adopt an operating mode for the treatment of Alzheimer's disease and in said operating mode to specify predetermined setting parameters for at least one of a frequency control unit, a pulse control unit, or a pulse frequency control unit (see para. 0072 – “For example, the present disclosure can be used in the treatment of a Central Nervous System (CNS) disease, such as Alzheimer's Disease.”; Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”).
Furthermore, regarding claim 14, Konofagou further teaches wherein the device includes auto-ignition (see par. 0008 – “The method can further include modulating the acoustic pressure in real time [auto-ignition] based on the cavitation signal magnitude.”).
Furthermore, regarding claim 16, Konofagou further teaches a system for treating brain tissue or areas of a body, the system comprising
the device (10; 20; 80; 90) for extracorporeal shock wave therapy according to claim 1 (see claim 1 above), and
a processor unit configured thereto, to receive diagnostic data from at least one of a data memory or a diagnostic device (Fig. 1; see para. 0037 – “For example, information from the neuronavigation system 120 can be used to control the ultrasound transducer 112 and/or one or more trackers 114.”),
determine setting parameters for the device (10; 20; 80; 90) for extracorporeal shock wave therapy depending on the diagnostic data, and send the setting parameters to the device (10; 20; 80; 90) for extracorporeal shock wave therapy (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”).
Furthermore, regarding claim 17, Konofagou 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 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 (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”).
Furthermore, regarding claim 18, Konofagou further teaches wherein the diagnostic device is an imaging device for 3D representations of a head and the processor unit 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 (see para. 0075 – “For comparison, 3D numerical simulation of the acoustic pressure field was performed prior to and after opening of the blood-brain barrier using focused ultrasound.”).
Furthermore, regarding claim 22, Konofagou further teaches a method for providing setting parameters for a treatment of Alzheimer's disease with the system (100) according to claim 16 (see claim 16 above), the method comprising the steps of:
providing data from a data memory or a diagnostic device (Fig. 1; see para. 0037 – “For example, information from the neuronavigation system 120 can be used to control the ultrasound transducer 112 and/or one or more trackers 114.”), and
determining setting parameters for the device (10; 20; 80; 90) for extracorporeal shock wave 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 (e.g., CT or MRI data) before and after one or more treatments, simulation calculation data, measurement data (e.g., blood measurements) or data on established treatment courses and successes (see para. 0036 – “For example, and not limitation, a neuronavigation system 120 can be used to map at least a portion of the subject's brain tissue before or during treatment with focused ultrasound.”; see para. 0038 – “For purpose of illustration and not limitation, and as embodied herein, the neuronavigation system 120 can include one or more imaging devices (e.g., cameras) 125 for mapping the brain tissue. The imaging devices can use a variety of techniques, such as CT scanning, MRI, or positron emission tomography (PET).”).
Furthermore, regarding claim 23, Konofagou 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 (157) (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”).
Furthermore, regarding claim 25, Konofagou 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 unit (see claim 22 above; see para. 0047 – “As embodied herein, field-programmable gate arrays (FPGAs) can be used in an application-specific integrated circuit (ASIC) for the wearable ultrasound assembly to limit the amount of external computing resources required.”).
Furthermore, regarding claim 26, Konofagou further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 300 kHz (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”; see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
Furthermore, regarding claim 27, Konofagou further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 250 kHz (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”; see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
Furthermore, regarding claim 28, Konofagou further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 200 kHz (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”; see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
Furthermore, regarding claim 29, Konofagou further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 150 kHz (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”; see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
Furthermore, regarding claim 30, Konofagou further teaches wherein the capacitor discharge resonant circuit has the discharge frequency distribution with the maximum being below 100 kHz (Fig. 1; see para. 0037 – “… the neuronavigation system 120 can be used during treatment to monitor and adjust the course of treatment, such as, and without limitation, the placement of the ultrasound transducer 112, the ultrasound frequency, duty cycle, a pulse length, a pulse repetition frequency, a burst length, a burst repetition frequency, burst count, a pressure range, a duration, and any other suitable parameters as known in the art…”; see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
Furthermore, regarding claim 32, Konofagou further teaches method for the treatment of Alzheimer's disease, comprising:
providing the device for extracorporeal shock wave therapy according to claim 1 (see claim 1 above),
placing the at least one shock wave applicator (3) on a patient’s head (see para .0058 – “As illustrated in FIG. 9, the method 900 can include securing the housing of the ultrasound assembly [shock wave applicator] to the head of a subject 901.”), and
operating the shock wave generator (12) to apply shock or pressure waves to the patient's head (see para. 0064 – “As embodied herein, the method 900 can further include providing focused ultrasound to the targeted region to induce cavitation 903.”).
Furthermore, regarding claim 42, Konofagou further teaches wherein the shock wave that has left the shock wave applicator (3) has frequency bands whose dominant maxima are in the range between 80kHz and 850kHz (see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
Furthermore, regarding claim 43, Konofagou further teaches wherein the shock wave that has left the shock wave applicator (3) has frequency bands whose dominant maxima are in a range between 80kHz and 450kHz (see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
Furthermore, regarding claim 44, Konofagou further teaches wherein the shock wave that has left the shock wave applicator (3) has frequency bands whose dominant maxima are in a range between 80kHz and 350kHz (see para. 0064 – “As such, the focused ultrasound for use in the presently disclosed subject matter can have a frequency greater than about 16 kHz, and as embodied herein, can be within a range from about 50 kHz to about 20 MHz.”).
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 4-5, 10, 19, and 33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou in view of Schaden et al. (US 20070239080 A1, published October 11, 2007), hereinafter referred to as Schaden.
Regarding claim 4, Konofagou teaches all of the elements disclosed in claim 1 above.
Konofagou teaches communication between the shock wave generator and the shock wave applicator, and it would be inherent to connect a generator and an applicator via a cable, but does not explicitly teach a coaxial high-voltage cable between the shock wave generator (12) and the shock wave applicator (3), wherein the coaxial high-voltage cable is longer than 1.5 m.
Whereas, Schaden, in the same field of endeavor, teaches a coaxial high-voltage cable between the shock wave generator (12) and the shock wave applicator (3), wherein the coaxial high-voltage cable is longer than 1.5 m (see para. 0145 – “FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shock wave generator (43) (shock wave head) and a control and power supply unit (41) for the shock wave head (43) connected via electrical cables (42) [coaxial cable] which may also include water hoses that can be used in the context of the present invention [which can be longer than 1.5 m]. However, as the person skilled in the art will appreciate, other set-ups are possible and within the scope of the present invention.”).
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 communication between the shock wave generator and the shock wave applicator, as disclosed in Konofagou, by having a coaxial cable between the shock wave generator and the shock wave applicator, as disclosed in Schaden. One of ordinary skill in the art would have been motivated to make this modification in order to have a reliable signal between the generator and the applicator.
Furthermore, regarding claim 5, Schaden further teaches a toroidal or ring core coil arranged between the shock wave applicator (3) and the shock wave generator (12) 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 shock wave 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/shock wave generator (shock wave head) having an electromagnetic flat coil 50 as the generating element.”).
Furthermore, regarding claim 10, Schaden further teaches at least one applicator (3) with a reflector (241) and a pair of electrodes (242, 242'), and a focus control unit configured to focus and defocus delivered shock waves by shifting a position of at least one of the electrodes (242, 242') in the reflector (241) (see para. 0149 – “FIG. 9 is a simplified depiction of the pressure pulse/shock wave generator (shock wave head) comprising a cylindrical electromagnet as a generating element 53 and a first reflector having a triangular shape to generate nearly plane waves 54 and 51.”).
Furthermore, regarding claim 19, Schaden further teaches an ultrasound device and a combination control arrangement adapted to apply ultrasound and shock waves to a same treatment area (see para. 0122 – “After identifying a risk prone candidate providing one or a series of two or more exposure treatments with focused or unfocused, divergent, planar or near planar shock waves or convergent far-sighted focused shock waves or diffused shock waves to the treatment site, in this example the region surrounding or in proximity to an occurrence risk location. Then after treatments the physician can optionally ultrasound visually or otherwise determine the increase in regeneration or vascularization in the treated tissue after a period of time.”).
Furthermore, regarding claim 33, Schaden further teaches wherein the coaxial high-voltage cable is longer than 2.0 m (see para. 0145 – “FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shock wave generator (43) (shock wave head) and a control and power supply unit (41) for the shock wave head (43) connected via electrical cables (42) [coaxial cable] which may also include water hoses that can be used in the context of the present invention [which can be longer than 2.0 m]. However, as the person skilled in the art will appreciate, other set-ups are possible and within the scope of the present invention.”).
Furthermore, regarding claim 34, Schaden further teaches wherein the coaxial high-voltage cable is longer than 3.0 m (see para. 0145 – “FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shock wave generator (43) (shock wave head) and a control and power supply unit (41) for the shock wave head (43) connected via electrical cables (42) [coaxial cable] which may also include water hoses that can be used in the context of the present invention [which can be longer than 3.0 m]. However, as the person skilled in the art will appreciate, other set-ups are possible and within the scope of the present invention.”).
Furthermore, regarding claim 35, Schaden further teaches wherein the coaxial high-voltage cable is longer than 5.0 m (see para. 0145 – “FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shock wave generator (43) (shock wave head) and a control and power supply unit (41) for the shock wave head (43) connected via electrical cables (42) [coaxial cable] which may also include water hoses that can be used in the context of the present invention [which can be longer than 5.0 m]. However, as the person skilled in the art will appreciate, other set-ups are possible and within the scope of the present invention.”).
Furthermore, regarding claim 36, Schaden further teaches wherein the coaxial high-voltage cable is longer than 10.0 m (see para. 0145 – “FIG. 5 is a simplified depiction of a set-up of the pressure pulse/shock wave generator (43) (shock wave head) and a control and power supply unit (41) for the shock wave head (43) connected via electrical cables (42) [coaxial cable] which may also include water hoses that can be used in the context of the present invention [which can be longer than 10.0 m]. However, as the person skilled in the art will appreciate, other set-ups are possible and within the scope of the present invention.”).
The motivation for claims 5, 10, 19, and 33-36 was shown previously in 4.
Claims 11-12, 24, 31, and 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou in view of Theuer (US 20200038694 A1, published February 6, 2020), hereinafter referred to as Theuer.
Regarding claim 11, Konofagou teaches all of the elements disclosed in claim 1 above, and
Konofagou further teaches wherein the at least one shock wave applicator comprises two or more shock wave applicators (3) each having a pair of electrodes (242, 242') (see para. 0051 – “Thus, the top metal pads of the ASIC chips can be used as the bottom electrodes for the piezoelectric transducer. The top electrode, which can also serve as an etch mask for the piezoelectric material, can be deposited and patterned lithographically.”).
Konofagou teaches a shock wave applicator, but does not explicitly teach the shock wave applicator having at least one discharge capacitor.
Whereas, Theuer, in the same field of endeavor, teaches wherein the at least one shock wave applicator comprises two or more shock wave applicators (3) each having a pair of electrodes (242, 242'), and at least one discharge capacitor (see para. 0131 – “Pressure shocks can be induced via capacitive discharges in piezoelectric or electromagnetic applicators or be applied via focused, pulsed sine oscillations (p-HIFU) in the tumor region.”).
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 shock wave applicator, as disclosed in Konofagou, by having the shock wave applicator with at least one discharge capacitor, as disclosed in Theuer. One of ordinary skill in the art would have been motivated to make this modification in order to have selective, non-thermal treatment of the mammary carcinoma, as taught in Theuer (see para. 0131).
Furthermore, regarding claim 12, Konofagou further teaches wherein the two or more shock wave applicators (3) are adapted to be at least one of a) directed at a brain region from different directions, or b) ignited in a time-delayed manner relative to one another (see para. 0045 – “For example, the arrays or patches can be driven at different phases with different time delays to achieve constructive superposition of the pressure fields in the target region.”).
Furthermore, regarding claim 24, Theuer further teaches implementing the artificial intelligence in an analysis module which receives the data, the analysis module conducting an 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 (10; 20; 80; 90) for extracorporeal shock wave therapy (see para. 0082 – “According to the invention, the physical characteristics of patient-individual metastasis cells are determined via AFM (atomic force microscopy) before the TMI treatment of bone metastases, are integrated into FEM simulation models of non-linear pressure propagation through the tumor region and treatment parameters which lead to the lethal damage of malignant cells in the tumor region are determined with the help of comparative comparisons of the simulation results.”).
Furthermore, regarding claim 31, Theuer further teaches wherein the at least one shock wave generator (12) is an electrohydraulic shock wave generator (see para. 0022 – “The device can comprise at least one ballistic and/or at least one electrohydraulic or piezoelectric shockwave generator or corresponding treatment applicators, in particular for producing positive shockwave impulses.”).
Furthermore, regarding claim 37, Theuer further teaches wherein the frequency control unit (11) is configured to adjust the electrohydraulic shock wave generator (12) so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 300kHz (see para. 0022 – “The device can comprise at least one ballistic and/or at least one electrohydraulic or piezoelectric shockwave generator or corresponding treatment applicators, in particular for producing positive shockwave impulses.”; see para. 0035 – “It is advantageous if the components of the treatment applicators…comprise low-frequency (20-30 kHz) plane impulse generators…”).
Furthermore, regarding claim 38, Theuer further teaches wherein the frequency control unit (11) is configured to adjust the electrohydraulic shock wave generator (12) so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 250kHz (see para. 0022 – “The device can comprise at least one ballistic and/or at least one electrohydraulic or piezoelectric shockwave generator or corresponding treatment applicators, in particular for producing positive shockwave impulses.”; see para. 0035 – “It is advantageous if the components of the treatment applicators…comprise low-frequency (20-30 kHz) plane impulse generators…”).
Furthermore, regarding claim 39, Theuer further teaches wherein the frequency control unit (11) is configured to adjust the electrohydraulic shock wave generator (12) so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 200kHz (see para. 0022 – “The device can comprise at least one ballistic and/or at least one electrohydraulic or piezoelectric shockwave generator or corresponding treatment applicators, in particular for producing positive shockwave impulses.”; see para. 0035 – “It is advantageous if the components of the treatment applicators…comprise low-frequency (20-30 kHz) plane impulse generators…”).
Furthermore, regarding claim 40, Theuer further teaches wherein the frequency control unit (11) is configured to adjust the electrohydraulic shock wave generator (12) so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 150kHz (see para. 0022 – “The device can comprise at least one ballistic and/or at least one electrohydraulic or piezoelectric shockwave generator or corresponding treatment applicators, in particular for producing positive shockwave impulses.”; see para. 0035 – “It is advantageous if the components of the treatment applicators…comprise low-frequency (20-30 kHz) plane impulse generators…”).
Furthermore, regarding claim 41, Theuer further teaches wherein the frequency control unit (11) is configured to adjust the electrohydraulic shock wave generator (12) so that the capacitor discharge resonant circuit has the discharge frequency distribution that has the maximum below 100kHz (see para. 0022 – “The device can comprise at least one ballistic and/or at least one electrohydraulic or piezoelectric shockwave generator or corresponding treatment applicators, in particular for producing positive shockwave impulses.”; see para. 0035 – “It is advantageous if the components of the treatment applicators…comprise low-frequency (20-30 kHz) plane impulse generators…”).
The motivation for claims 24, 31, and 37-41 was shown previously in claim 11.
Claims 15 and 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over Konofagou in view of Moses et al. (US 20120053449 A1, published March 1, 2012), hereinafter referred to as Moses.
Regarding claim 15, Konofagou teaches all of the elements disclosed in claim 1 above.
Konofagou teaches a circuit, but does not explicitly teach where the device includes a capacitor with specific parameters.
Whereas, Moses, in an analogous field of endeavor, teaches wherein at least one of: A) the discharge resonant circuit has a capacitor with a capacitance of 50 nF - 400 nF, B) the discharge resonant circuit has a capacitor with a charging voltage of between 1kV and 20 kV, C) the 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 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. 0133 – “In one embodiment, the voltage load V on the capacitor ranges between 0 V and 5 kV.”).
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 device, as disclosed in Konofagou, by having the device include a capacitor with a charging voltage of between 1kV and 20 kV, as disclosed in Moses. One of ordinary skill in the art would have been motivated to make this modification in order to have effective interaction of the magnetic pulse on the brain for the application of transcranial magnetic stimulation, as taught in Moses (see para. 0069).
Furthermore, regarding claim 45, Moses further teaches wherein the discharge resonant circuit has a capacitor with a charging voltage of between 1kV and 7.5 kV (see para. 0133 – “In one embodiment, the voltage load V on the capacitor ranges between 0 V and 5 kV.”).
Furthermore, regarding claim 46, Moses further teaches wherein the 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. 0133 – “In one embodiment, the voltage load V on the capacitor ranges between 0 V and 5 kV…In one embodiment, the capacitor capacitance is 109 μF.” Capacitor energy E = ½* capacitor capacitance C* voltage V2 = ½ * 109 μF * (250 V)2 = 3.4 J, which is between 0.5 J and 5 J).
The motivation for claims 45-46 was shown previously in claim 15.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Konofagou in view of Cain et al. (US 20080319356 A1, published December 25, 2008), hereinafter referred to as Cain.
Regarding claim 20, Konofagou teaches all of the elements disclosed in claim 16 above.
Konofagou teaches determining setting parameters for the device for extracorporeal shock wave therapy depending on the diagnostic data, but does not explicitly teach determining dispensing parameters for the medicine delivery device depending on the diagnostic data.
Whereas, Cain, in the same field of endeavor, teaches a medicine delivery device and the processor unit 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 (see para. 0113 – “Moreover, the nature of the feedback received can be used to adjust acoustic parameters (and associated system parameters) to optimize the drug delivery and/or tissue erosion process.”).
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 determining setting parameters for the device for extracorporeal shock wave therapy depending on the diagnostic data, as disclosed in Konofagou, by also determining dispensing parameters for the medicine delivery device depending on the diagnostic data, as disclosed in Cain. One of ordinary skill in the art would have been motivated to make this modification in order to continuously monitor drug delivery in real time, as taught in Cain (see para. 0113).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Konofagou in view of Theuer (WO 2010049176 A1, published May 6, 2010), hereinafter referred to as Theuer ‘176.
Regarding claim 21, Konofagou teaches all of the elements disclosed in claim 16 above.
Konofagou teaches determining setting parameters for the device for extracorporeal shock wave therapy depending on the diagnostic data, but does not explicitly teach determining temperature control parameters for the temperature control device (157) as a function of the diagnostic data.
Whereas, Theuer ‘176, in the same field of endeavor, teaches a temperature control device (157) for a patient's head and the processor unit is further configured thereto, to determine temperature control parameters for the temperature control device (157) as a function of the diagnostic data, and to transfer the temperature control parameters to the temperature control device (157) (see pg. 7, para. 5 – “Preferably, the temperature and / or acceleration sensor are connected to a controller, which is further coupled to the tempering device and the vibration element or the frequency generator, so that the treatment parameters with respect to the ultrasonic frequency, the ultrasound intensity, the pulse duration and the tissue temperature in dependence of the measured values of the temperature - And / or acceleration sensor are controllable.”).
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 determining setting parameters for the device for extracorporeal shock wave therapy depending on the diagnostic data, as disclosed in Konofagou, by also determining temperature control parameters for the temperature control device (157) as a function of the diagnostic data, as disclosed in Theuer ‘176. One of ordinary skill in the art would have been motivated to make this modification in order to provide further improve selective treatment to the tumor tissue and avoid damage to the healthy tissue, as taught in Theuer ‘176 (see pg. 5, para. 1).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Marlinghaus et al. (US 20140114326 A1, published April 24, 2014) discloses treating the human or animal brain with shock waves has a shockwave transducer coupled to a position sensor for detecting the position of the shockwave transducer.
Schultheiss et al. (US 20060100550 A1, published May 11, 2006) discloses activating an acoustic shock wave generator or source to emit acoustic shock waves; and subjecting the substance to the acoustic shock waves stimulating said substance wherein the substance is positioned within a path of the emitted shock waves and away from a geometric focal volume or point of the emitted shock waves.
Reitter (US 4782821 A, published November 8, 1988) discloses a shock wave generator for an installation for non-contacting disintegration of calculi in the body of a life form has a coil with spirally arranged turns and a mem brane formed of an electrically conductive material lying opposite said coil and terminating a space filled with a fluid, the coil being connectable to a high-voltage supply.
Peters et al. (US 20240316369 A1, published September 24, 2024 with a priority date of July 12, 2022) discloses generating extracorporeal shock waves in a thoracic region of a user includes a shock wave transducer unit to generate extracorporeal shock waves and configured to be placed on the skin of the user to apply shock wave therapy.
Xiao et al. (US 20170245928 A1, published August 31, 2014) discloses where a controller receives feedback signals representing a value of a characteristic of or a result of the pulses and generates at least one of the power supply control signal and the pulse generator control signal based on the received feedback signals.
Khokhlova et al. (US 20190117243 A1, published April 25, 2019) discloses directing ultrasound waveforms toward the target tissue of a patient; generating ultrasound shock fronts at the target tissue of a patient; generating a cavitation inside the target tissue of a patient by the ultrasound shock front; and delivering the treatment composition to the patient.
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/Nyrobi Celestine/Examiner, Art Unit 3798