DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10 September 2026 has been entered.
Formal Matters
Claims 16, 18-22 are cancelled. Claims 1, 7, and 24 are currently amended. Claims 1-15, 17, and 23-27 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10 September 2026 has been considered by the examiner. A signed copy is attached. Applicant is advised that only the English language portions have been considered.
Objections/Rejections Withdrawn
The rejection of claims 1-15, 17, and 23-27 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a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, are withdrawn in light of Applicant’s amendments.
Response to Arguments
Regarding the rejection under 35 USC 103, Applicant argues that the cited references do not teach or suggest the claims as currently amended in claim 1 (Remarks, numbered p. 7). Applicant’s arguments have been fully considered, but they are not persuasive. A modified rejection, based on Applicant’s amendments is set forth below.
Applicant argues that the rejection relies on “unlike, incompatible physical variables without explaining why a person of ordinary skill in the art would treat them as interchangeable” (Remarks, numbered p. 7). Applicant argues that Yurek’s irrigation pulse rate cannot be substituted for the frequency of an acoustic wave merely because both may be expressed in hertz (Remarks, numbered p. 7). Applicant’s arguments have been fully considered, but they are not persuasive. The frequency pulse-rate of Yurek is disclosed as an oscillatory frequency designed to generate laminar and fluidic flow in the calyx of a renal pelvis of a kidney in order to “dislocate a kidney stone” (¶119). Yurek’s oscillatory flow pulses are mechanical energy with a defined frequency range which has an effect on the surrounding tissue. Bonutti’s piezoelectric device 30 also generates mechanical energy pulses that are oscillatory in frequency (¶41). Both of Yurek’s and Bonutti’s mechanical vibrations are oscillatory waves designated by frequency.
Although Yurek utilizes an external flow, with an irrigation flow pressure, to create a vortex effect within the renal pelvis (Yurek, ¶162), one of ordinary skill in the art would recognize that the vortex effect created within the renal pelvis is the mechanism by which the fragments were dislodged. Bonutti expressly teaches the implanted atraumatic turbulence generator for the same purpose, to create intra-organ oscillations which “direct therapeutic energy to the treatment site to fragment the particulate material” (Bonutti, ¶7). Because Yurek teaches directed therapeutic energy to the treatment site, using laminar and turbulent flows, in the calyx and renal pelvis of human kidneys, a person of ordinary skill in the art, seeking to treat the same anatomical area in human patients using laminar and turbulent (atraumatic) flows, would reasonably consult Yurek’s vortex solution. Yurek’s fluidic irrigation (laminar and turbulent flows) can be performed with a number of different devices and incorporated along with Bonutti’s base devices (same location, flow, and frequency interaction) using known treatment methods without redesigning Bonutti’s core device. Yurek provides the motivating solution with the express recognition of repeated fluidic flow as the basis for the resulting effect of dislodging calculi in the calyx and renal pelvis of the kidney.
A person of ordinary skill in the art attempting to utilize naturally occurring fluid within the human kidney as a way to dislodge or fragment renal calculi within a kidney would look for established fluidic laminar and turbulent flow designs to avoid creating a novel fluidic interface. Yurek’s flow pressures and frequencies are expressly taught as being oscillated (e.g. via sinusoidal waveform), providing a pulsed pressure effect, variable, and having differential pressure in order to affect movement (Yurek, ¶119). Yurek’s teachings of flow variation are adaptable and can be modified to on a use-case and individual patient basis (Yurek, ¶119) using Bonutti’s base device to enable extracorporeal oscillation while utilizing the naturally occurring fluid within the kidney and more specially the calyx and the renal pelvis.
Applicant argues that the functional limitations of the claims are not met by the references where Bonutti fails to provide dimensions or other structural information demonstrating that its piezoelectric device 30 can traverse a uteroscope or remain in the renal pelvis for the claimed duration (Remarks, numbered p. 7). Applicant’s argument has been fully considered, but is not persuasive. FIGs 13A of Bonutti exemplifies energy focusing device 28 (¶82), which Bonutti expressly describes as “a piezoelectric device 30, which includes a ferromagnetic plate 32 attached to a ceramic disk 34, that is positioned on stent 112”, which is designed to be implanted and positionable in a vessel of a patient (¶82). Given the dimensions of a typical vessel-indwelling stent, one of ordinary skill in the art would reasonably understand that the size and shape of Bonutti’s device would meet the claim limitations of being of sized and shaped to be deployable through a uteroscope. Applicant’s attention is also directed to MPEP 2144.04. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Applicant argues that the piezoelectric transducer driven at 20kHz does not necessarily pass through every intervening frequency and that there is no evidence of Bonutti’s device performing such a sweep (Remarks, numbered p. 8). Applicant’s argument has been fully considered, but it is not persuasive. The prior Office Action did not state that Bonutti’s device performed a frequency sweep. Instead, the prior Office Action broadly interpreted the claims as written while interpreting the dependency of claim 17 on claim 1 in light of physical frequencies as a matter of classical physics and what is disclosed in the specification as to the claimed frequency ranges. The frequency of 150 Hz to 350 Hz in claim 1 has been amended to recite that this is an “operating frequency” (which is a sonic range), while the recitation in claim 17 remains that “the acoustic wave generating element further produces ultrasonic waves at frequencies greater than 20,000Hz” (e.g. 20kHz in the ultrasonic range). Accordingly, the broadest reasonable interpretation of claim 1 is that the device is operated within a frequency range of 150Hz to 350Hz (e.g. sonic range), as expressly written, but that the device is also “capable of” producing ultrasonic waves in the ultrasonic frequency range, at frequencies greater than 20,000Hz. Claim 17, which is dependent on claim 1, is not required to “operate” in an ultrasonic range, but the device merely needs to be able to produce ultrasonic waves at frequencies greater than 20,000Hz. This distinction is broadly interpreted as a continued comparison to the device of Bonutti, which is also able to produce waves at frequencies greater than 20,000Hz, as well as the frequences of Yurek, which are operated to produce laminar and turbulent flow.
Applicant is reminded that the subject matter of dependent claims is required to be subsumed within independent claims, even if the independent claims are silent as to the level of detail of the dependent claims. The dependency must still have antecedent basis. Accordingly, Applicant cannot disclaim the frequency range of independent claim 1 while continuing to hold to the importance of the frequency range of claim 17. It is for this reason, among others, that the interpretation is made regarding the capability of the device meeting the ultrasonic frequency requirements of claim 17, which operating (as amended) at the frequency of claim 1. Accordingly, the operation of the device for turbulent flow at a lower frequency (“150Hz to 350 Hz”) range and ability to produce waves at a higher frequency range (“greater than 20,000 Hz”) is a result-effective variable where the device itself must be capable of reaching both ranges as a matter of physical requirements. Frequency selection depends on the application. Lower frequencies of 150Hz-300Hz offer resonance-based control and acoustic flow manipulation. Yurek expressly teaches this frequency for laminar and turbulent flow in order to dislodge calcifications in the kidney. However, the device of Bonutti also offers ultrasonic frequencies which can also be used for precise fluidic flow determinations as well as to fragment renal calculi.
A user of the device may select a frequency range at a lower or higher end for any given use-case, but the device itself is still required by the express functional recitations of the claims to be capable of producing acoustic waves in a range from 150Hz to frequencies greater than 20,000 Hz. Accordingly, the basis of the examiner’s rationale for the “pass through” 150Hz to 350Hz is that in order to achieve the frequencies of dependent claim 17, the device must pass through the frequency range of independent claim 1 from a ground state of zero (0 Hz) even if an operator does not perceive the spread or the sweep occurring because of the real-time transit of the frequencies. Simply put, the expressly claimed ranges are considered a physically functional aspect of the device. The selectability or tunability of any particular frequency is a user-based function that is a results-effective variable. As explained of record, a results-effective variable can be optimized. One of skill in the art would clearly recognize that frequencies can be optimized depending on the end effect desired for the use case. As such, adjusting the frequencies of the device would amount to nothing more than routine experimentation that can be optimized on an individual use case basis. See, In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977) and In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980)).
Regarding Applicant’s argument in response to the statement in the prior Office Action regarding a lack of criticality in the specification for the recited ranges, the point is important because the lack of a statement of criticality for the ranges means that there would be no unexpected result by the medical apparatus operating in that range because the device is innately physically capable of having the frequency adjusted. Moreover, overlapping frequences in the recites ranges are expressly taught by Yurek, which teaches that the shape, spread, flow rate and/or type of flow may be oscillating or otherwise varying along with differential pressure where pulses of irrigation fluid are at more than 100 Hz (¶119) and Bonutti teaches that frequencies in the ultrasonic (20KHz) are used for human therapeutic purposes (¶46). Accordingly, the rejections are maintained.
Claim Rejections - 35 USC § 103
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 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 1, 4-8, 11-15, 17, and 23-27 remain rejected under 35 U.S.C. 103 as being unpatentable over Bonutti, US 20060064082 (23 March 2006) in view of Yurek, US 20210121188 (29 April 2021, benefit to 31 July 2020), for the reasons of record and the reasons set forth herein.
Regarding independent claim 1, Bonutti teaches a medical apparatus (FIG 1, implanted medical device 12; ¶7) for mitigating formation of kidney stones in a human patient (¶61), the medical apparatus (12) comprising:
an atraumatic turbulence generator (FIGs 2, 4; ¶41, piezoelectric device 30 ferromagnetic plate 32, ceramic disk 34) that is sized and shaped to be deployable (FIGs 2, 4, 13A; ¶¶37, 82) and to be left behind after a deployment procedure (“medical implant is surgically or percutaneously position at a treatment site”, ¶7) to reside in a human kidney (¶61),
the atraumatic turbulence generator (FIGs 2, 4; ¶41, piezoelectric device 30 ferromagnetic plate 32, ceramic disk 34) comprising an acoustic wave generating element for generating, after having been left behind after a deployment procedure (¶7) to reside within a human kidney (¶61), an acoustic wave (FIG 4; ¶46) into a naturally occurring fluid (¶40) within the kidney (¶61) to dislodge or fragment renal calculi within the human kidney (¶61); and
an actuator (56) operatively connected to the atraumatic turbulence generator to control the atraumatic turbulence generator to produce the acoustic wave (¶46); and
a source of electrical or electromagnetic energy, arranged to drive the atraumatic turbulence generator to produce the acoustic wave (FIG 4, energy system 56; ¶46)
Bonutti does not expressly teach a frequency within a range of 150 Hz and 350 Hz, the specific placement location within the renal pelvis of the kidney, or the function of dislodging or fragmenting renal calculi occurring within the specific location of a calyx of the kidney. Additionally, Bonutti does not expressly teach that the atraumatic turbulence generator is deployable through a ureteroscope.
However, Bonutti, teaches the use of an acoustic wave generator in the kidney to aid in the breaking-up or fragmenting of kidney stones (¶61) and FIG 13A of Bonutti exemplifies energy focusing device 28 (¶82), which Bonutti expressly describes as “a piezoelectric device 30, which includes a ferromagnetic plate 32 attached to a ceramic disk 34, that is positioned on stent 112”, which is designed to be implanted and positionable in a vessel of a patient (¶82). Yurek teaches the removal of kidney stones (¶135) using removal device 100 to move kidney stones from a calyx into a renal pelvis (FIGs 2A, B; ¶135). Shockwave lithotripsy is taught at ¶3. Laminar flow and turbulent flow for stone removal in kidneys are taught at ¶119. Yurek teaches the flow rate is taught as oscillating or otherwise varying along with differential pressure at “more than 100 Hz” (¶119). Yurek teaches that dynamic irrigation streams may be configured to optimize removal of kidney stones, including in a calyx (¶119). Yurek also teaches a flow generator (catheter 102, ¶83) is configured to reside in the renal pelvis of a human kidney (“the ureteroscope may be used repeatedly until clinically significant kidney stones and kidney stone fragments are broken up and removed from the body”, ¶6).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Bonutti and Yurek, given that the prior art included each element claimed, although not necessarily in a single reference. Bonutti and Yurek teach in the same field of endeavor, that of devices and methods of kidney stone removal.
Bonutti discloses the claimed base apparatus comprising an atraumatic turbulence generator sized and shaped to be injected or implanted into a renal pelvis of a human kidney. FIG 13A of Bonutti exemplifies energy focusing device 28 (¶82), which Bonutti expressly describes as “a piezoelectric device 30, which includes a ferromagnetic plate 32 attached to a ceramic disk 34, that is positioned on stent 112”, which is designed to be implanted and positionable in a vessel of a patient (¶82). Given the dimensions of a typical vessel-indwelling stent, one of ordinary skill in the art would reasonably understand that the size and shape of Bonutti’s device would meet the claim limitations of being of sized and shaped to be deployable through a uteroscope.
Bonutti does not expressly teach that a frequency within a range of 150 Hz and 350 Hz, that the specific location within the kidney (¶61) is within the renal pelvis, or to dislodge or fragment renal calculi within a calyx. Yurek specifically addresses dislodging stones from a renal calyx and renal pelvis in a frequency range above 100 Hz (¶¶119, 135).
With regard to a frequency within a range of 150 Hz and 350 Hz, Bonutti teaches that “[t]he frequency of the acoustic waves may be in any suitable range” (¶46). Yurek teaches a range of “more than 100 Hz” (¶119), which overlaps with the claimed range of operating frequency. On one hand, Bonutti teaches frequencies in the ultrasonic (20KHz), sonar, medical ultrasonic, and microwave acoustic ranges at ¶46. However, it is also understood that merely initializing the field and driving it into the ultrasonic range of more than 20000 Hz (e.g. specification and claim 17) would permit the device to pass through the range of 150 Hz and 350 Hz.
As taught by Yurek, sonic frequency ranges of 150 Hz and 350 Hz are generally regarded as providing a fluidic or laminar flow within the naturally occurring fluid of a human kidney (¶119). It is well known in the art that fragmenting renal calculi requires more energy than what is available in the sonic Hz range (Bonutti, ¶46). However, the claimed range of 150 Hz and 350 Hz is broadly interpreted as being a sufficient frequency at which to create laminar and fluidic flow in order to dislodge, according to Yurek (¶119), but alone are not sufficiently energetic to “fragment renal calculi”, without more. Accordingly, given that claim 17 is also dependent on claim 1, the range of 150 Hz and 350 Hz is broadly reasonably interpreted as both a base range and also as a pass-through range where the device is also capable of reaching ultrasonic frequencies (above 20 KHz), which is the well-studied and well-accepted range at which renal calculi are able to be fragmented (Bonutti, ¶46; Yurek, ¶3).
Additionally, the specification does not teach the criticality of the 150 Hz and 350 Hz range “to dislodge or fragment renal calculi”. Instead, the Specification discloses that “oscillation element 108 can produce acoustics waves at frequencies between about 150 Hz and about 350 Hz” (¶25). At ¶5, the Specification discloses that “the medical apparatus optionally be configured such that the element can produce acoustic waves at frequencies between about 150 Hz and about 350 Hz”. Those are the only two recitations in the disclosure of the range of 150 Hz and 350 Hz. Accordingly, the range is understood to be merely exemplary. There is no discussion in the disclosure about the claimed range of 150 Hz and 350 Hz being critical to the function of the device such that the range is so limited in order to carry out the function “to dislodge or fragment renal calculi”. There is no teaching in the disclosure or the prior art regarding a physically known benefit for the medical apparatus to operate in that range other than to engage in the turbulent or laminar flow as disclosed by Yurek. There is no criticality or unexpected result provided in the disclosure for the apparatus to operate in that range, other than the turbulent or laminar flow as disclosed by Yurek.
Although Yurek utilizes an external flow with an irrigation flow pressure to create a vortex effect within the renal pelvis (Yurek, ¶162), one of ordinary skill in the art would recognize that the vortex effect created within the renal pelvis is the mechanism by which the fragments were dislodged, rather than the manner in which the flow was initiated. Bonutti expressly teaches the implanted atraumatic turbulence generator for the same purpose, to create intra-organ oscillations which “direct therapeutic energy to the treatment site to fragment the particulate material” (Bonutti, ¶7). Because Yurek teaches directed therapeutic energy to the treatment site, using laminar and turbulent flows, in the calyx and renal pelvis of human kidneys, a person of ordinary skill in the art, seeking to treat the same anatomical area in human patients using laminar and turbulent (atraumatic) flows, would reasonably consult Yurek’s vortex solution. Yurek’s fluidic irrigation (laminar and turbulent flows) can be performed with a number of different devices and incorporated along with Bonutti’s base devices (same location, flow, and frequency interaction) using known treatment methods without redesigning Bonutti’s core device. Yurek provides the motivating solution with the express recognition of repeated fluidic flow as the basis for the resulting effect of dislodging calculi in the calyx and renal pelvis of the kidney.
A person of ordinary skill in the art attempting to utilize naturally occurring fluid within the human kidney as a way to dislodge or fragment renal calculi within a kidney would look for established fluidic laminar and turbulent flow designs to avoid creating a novel fluidic interface. Yurek’s flow pressures and frequencies are expressly taught as being oscillated (e.g. via sinusoidal waveform), providing a pulsed pressure effect, variable, and having differential pressure in order to affect movement (Yurek, ¶119). Yurek’s teachings of flow variation are adaptable and can be modified to on a use-case and individual patient basis (Yurek, ¶119) using Bonutti’s base device to enable extracorporeal oscillation while utilizing the naturally occurring fluid within the kidney and more specially the calyx and the renal pelvis.
Because the references address the same engineering problem (using acoustic wave devices to dislodge and fragment renal calculi in a human kidney) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adjusting the frequency and location of the fluidic devices within the renal pelvis and calyces of human kidneys), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 4, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element includes an acoustic transducer (¶¶14, 46, emitter 60 includes a piezoelectric transducer or any other acoustic source capable of emitting acoustic waves receivable by the implanted medical device 12).
Regarding claim 5, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element comprises an electromagnetic coil (¶49).
Regarding claim 6, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element includes a piezoelectric vibrator (30, ¶45).
Regarding claim 7, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the actuator and the source of energy are located within a manipulator housing (FIG 4, external energy unit 56);
wherein the source of energy includes a plurality of magnetic drives (¶70) and
a controller configured to selectively actuate the plurality of magnetic drives (claim 24) in accordance with a specified actuation sequence (claim 26);
wherein the source of energy and the acoustic wave generating element are configured such that, when arranged proximate to each other, the plurality of magnetic drives magnetically manipulate the acoustic wave generating to agitate the naturally occurring fluid within the renal pelvis (¶37).
Regarding claim 8, Bonutti modified by Yurek teaches the medical apparatus of claim 7, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the manipulator housing is configured to be located outside of a human body to actuate the acoustic wave generating element disposed within the renal pelvis of the human kidney (¶37).
Regarding claim 11, Bonutti modified by Yurek teaches the medical apparatus of claim 7, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element includes a magnetic stir element (FIG 4; ¶41) configured to move in response to the plurality of magnetic drives within the manipulator housing (¶70).
Regarding claim 12, Bonutti modified by Yurek teaches the medical apparatus of claim 8, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element is coin-shaped (FIG 6, energy focusing device 28).
Regarding claim 13, Bonutti modified by Yurek teaches the medical apparatus of claim 8, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element is pill-shaped (FIG 6, 28).
Regarding claim 14, Bonutti modified by Yurek teaches the medical apparatus of claim 8, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element comprises a non-symmetrical shape (FIG 5, 68).
Regarding claim 15, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches further comprising a binding configured to anchor the atraumatic turbulence generator (¶69) to a specified location within the human kidney (¶61).
Regarding claim 17, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element further produces ultrasonic waves at frequencies greater than 20,000 Hz (¶46).
Regarding claim 23, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches the device comprising a stent (112) for securing the atraumatic turbulence generator to at least one of a calyx of the human kidney or a urethra (FIGs 13A-B; ¶23).
Regarding claim 24, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the atraumatic turbulence generator includes at least one tether to facilitate travel of the acoustic wave generating element within the naturally occurring fluid (¶54).
Regarding claim 25, Bonutti modified by Yurek teaches the medical apparatus of claim 24, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the at least one tether includes a signal-communicative coupling for transmitting at least one of a power signal or a data signal to the acoustic wave generating element (¶70).
Regarding claim 26, Bonutti modified by Yurek teaches the medical apparatus of claim 25, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element is arranged within a diaphragm, the diaphragm configured to collectively expand and contract to produce the acoustic wave (¶41).
Regarding claim 27, Bonutti modified by Yurek teaches the medical apparatus of claim 25, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element is arranged as an arm extending from a central hub of the turbulence generator (¶54).
Claim 2 remains rejected under 35 U.S.C. 103 as being unpatentable over Bonutti, US 20060064082 (23 March 2006) (incorporating by reference: Rattner et al., US Patent 4,947,830 (14 August 1990)), in view of Yurek, US 20210121188 (29 April 2021, benefit to 31 July 2020), and further in view of Uber et al., US 20080228104 (18 September 2008) (incorporating by reference: Metcalf et al., US 5,299,354 (5 April 1994)), for the reasons of record and the reasons set forth herein.
Regarding claim 2, Bonutti modified by Yurek teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the acoustic wave generating element comprises:
a chassis (FIG 4, external energy unit 56; ¶49, exemplary shockwave generators, incorporating Rattner by reference, housing, claim 1);
an electric motor (¶49, exemplary shockwave generators, incorporating Rattner by reference, electric motor 12, electric motor 20, column 2, line 43; claim 6).
Bonutti modified by Yurek does not teach an eccentric weight disposed on a drive shaft of the electric motor; wherein rotation of the eccentric weight by the drive shaft causes the element to oscillate.
Uber teaches energy assisted medical devices and systems where the power or energy is controlled through a controller and mechanical actions or motion can be created from electrical power by any of many electromechanical elements, including motors, piezoelectric elements, and ultrasound transducers (¶70). Uber teaches that motion can be created using eccentric weights on a motor (¶70, incorporating by reference, Metcalf).
Metcalf teaches an eccentric element carried on the motor shaft where the eccentric element is rotated by the motor when the switch is on to provide an oscillating vibration signal (column 2, lines 14 and 17-19).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Bonutti, Bonutti incorporating Rattner, Yurek, Uber, and Uber incorporating Metcalf, given that the prior art included each element claimed, although not necessarily in a single reference. Bonutti, Bonutti incorporating Rattner, Yurek, Uber, and Uber incorporating Metcalf teach in the same field of endeavor, that of devices and methods of kidney stone removal.
Although, Bonutti and Bonutti incorporating Rattner by reference, modified by Yurek, discloses the claimed base apparatus comprising a chassis and electric motor, Bonutti modified by Yurek does not expressly teach an eccentric weight disposed on a drive shaft of the electric motor; wherein rotation of the eccentric weight by the drive shaft causes the element to oscillate.
Uber, and Uber incorporating Metcalf by reference, specifically teaches energy assisted medical devices and systems where the power or energy is controlled through a controller and mechanical actions or motion can be created from electrical power by any of many electromechanical elements, including motors, piezoelectric elements, and ultrasound transducers (¶¶70, 102) where the motion can be created using eccentric weights on a motor (Uber: ¶70, incorporating Metcalf, column 2, lines 14 and 17-19). Uber also teaches ultrasonic medical devices (¶¶7, 103) and the removal of kidney stones at ¶17.
Because Uber and Uber incorporating Metcalf teaches the same power or energy generating devices taught by Bonutti, where the motion can be created using eccentric weights on a motor, a person of ordinary skill in the art, seeking to control the motion of oscillation of the acoustic wave generating element, would reasonably consult Uber/Metcalf’s control solution. Uber/Metcalf’s control solution may be readily incorporated along with Bonutti’s base devices (same type of acoustic wave generating elements as taught by Uber/Metcalf) using known treatment devices and methods without redesigning Bonutti’s core delivery path. Because the references address the same engineering problem (using ultrasonic energy devices and controllers for medical treatment) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (generating motion using eccentric weights on a motor), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claim 3 remains rejected under 35 U.S.C. 103 as being unpatentable over Bonutti, US 20060064082 (23 March 2006) (incorporating by reference: Rattner et al., US Patent 4,947,830 (14 August 1990), in view of Yurek, US 20210121188 (29 April 2021, benefit to 31 July 2020), further in view of Uber et al., US 20080228104 (18 September 2008) (incorporating by reference: Metcalf et al., US 5,299,354 (5 April 1994)) and Hoffman et al., WO 2005023121 A1 (17 March 2005) (previously cited of record), for the reasons of record and the reasons set forth herein.
Regarding claim 3, Bonutti modified by Yurek, teaches the medical apparatus of claim 1, as set forth above, for the reasons set forth above.
Bonutti teaches wherein the element comprises:
a chassis (FIG 4, external energy unit 56; ¶49 of Bonutti, incorporating by reference to Rattner, exemplary shockwave generators, housing, claim 1).
Bonutti modified by Yurek does not teach a linear actuator and a weight configured to be oscillated along a linear path by the linear actuator.
Uber teaches energy assisted medical devices and systems where the power or energy is controlled through a controller and mechanical actions or motion can be created from electrical power by any of many electromechanical elements, including motors, piezoelectric elements, and ultrasound transducers (¶¶70, 102). Linear actuators are taught by Uber at ¶101, “linear actuators of various types can be used”. Uber also teaches that motion can be created using eccentric weights on a motor (Uber: ¶70, incorporating by reference, Metcalf et al). Metcalf teaches an eccentric element carried on the motor shaft where the eccentric element is rotated by the motor when the switch is on to provide an oscillating vibration signal (column 2, lines 14 and 17-19).
Hoffman teaches systems for medical treatments comprising low frequency vibrations (Abstract). Hoffman teaches the use of a lower stroke length enabled linear stepper motor with a smaller stator tube that achieve the same level of vibrational control that are generally less expensive to use (p. 81, lines 13-17). Ceramic servo motors coupled to a linear stage and provide virtually unlimited motion control (p. 81, lines 27-30). Hoffman also teaches that any known vibration source operable to generate vibration within the 1 - 1000 Hz range (so long as the therapeutic vibration wave form does not disable or interfere with the necessary ultrasonic imaging wave form) may be used, regardless of the level of provided vibratory emission control. Such vibration sources may for example comprise but not be limited to; linear stepper motors, linear stepper motors with displacement amplification, linear (non- stepper) motors, rotary motors with a rotary to linear conversion element such as a cam or crank, eccentrically spinning weights, and ceramic servo motors coupled to either a rotary (with cam) or linear stage (p. 59, line 32 to p. 60, line 8).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Bonutti, Bonutti incorporating Rattner, Yurek, Uber, and Uber incorporating Metcalf, and Hoffman , given that the prior art included each element claimed, although not necessarily in a single reference. Bonutti, Bonutti incorporating Rattner, Yurek, Uber, and Uber incorporating Metcalf, and Hoffman teach in the same field of endeavor, energy assisted medical devices. Bonutti and Uber teach exemplary embodiments of structural components of their energy-assisted medical devices. Both teach specific embodiments of energy assisted medical devices comprising electric motors. Metcalf further defines an eccentric element (weight) on the shaft of an electric motor that provides an oscillating vibration signal. Hoffman provides a rationale and motivation for using low frequency vibrations (in the 1-1000Hz range) in using of linear motors in energy assisted medical devices, including linear motors comprising eccentrically spinning weights.
Because Uber and Metcalf teaches the same power or energy generating devices taught by Bonutti, where the motion can be created using eccentric weights on a motor, a person of ordinary skill in the art, seeking to control the motion of oscillation of the acoustic wave generating element, would reasonably consult Uber/Metcalf’s control solution. Uber/Metcalf’s weighted control solution may be readily incorporated along with Bonutti’s base devices (same type of energy generating medical treatment elements as taught by Uber/Metcalf) using known treatment devices and methods without redesigning Bonutti’s core delivery path. Additionally, Uber and Hoffman’s linear actuators are also readily incorporated along with Bonutti’s base devises as they also relate to the same kind of energy generating medical treatment elements. Because the references address the same engineering problem (using ultrasonic energy devices and controllers for medical treatment) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (generating motion using eccentric weights on a motor), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Claims 9 and 10 remain rejected under 35 U.S.C. 103 as being unpatentable over Bonutti, US 20060064082 (23 March 2006), in view of Yurek, US 20210121188 (29 April 2021, benefit to 31 July 2020), and further in view of Hoffman et al., WO 2005023121 (17 March 2005), for the reasons of record and the reasons set forth herein.
Regarding claim 9, Bonutti modified by Yurek teaches the medical apparatus of claim 8, as set forth above, for the reasons set forth above.
Bonutti teaches that “[t]he external energy unit is positioned on a skin portion of the body of a patient or adjacent thereto, proximal to the treatment site. The energy signal is non-invasively transmitted through the body of the patient to the medical implant” (¶9).
However, Bonutti modified by Yurek does not expressly teach wherein the manipulator is wearable by a human patient during actuation.
Hoffman teaches energy assisted oscillatory (vibrating) medical devices (Abstract) as well as various wearables for the external vibratory devices including belt 130 and central panel 132 (p. 64, lines 20-30; FIG 12). Hoffman also teaches that the variation of engagement means for belt 130 and all variants thereof can be utilized and adapted for any body part and may also be adapted to provide support for other suitable vibrators or other percussion instruments by other names (p. 67, 21-25).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Bonutti, Yurek, and Hoffman , given that the prior art included each element claimed, although not necessarily in a single reference. Bonutti, Yurek, and Hoffman teach in the same field of endeavor, energy assisted oscillatory/vibrating medical devices.
Bonutti teaches positioning the external energy unit on a skin portion of the body of a patient or adjacent thereto (¶9), but does not expressly teach wherein the manipulator is wearable by a human patient during actuation. Hoffman teaches energy assisted oscillatory (vibrating) medical devices as wearables, including belt 130 and central panel 132 (p. 64, lines 20-30; FIG 12). Hoffman also teaches that the variation of engagement means for belt 130 and all variants thereof can be utilized and adapted for any body part and may also be adapted to provide support for other suitable vibrators or other percussion instruments by other names (p. 67, 21-25). Hoffman’s wearable solution may be readily incorporated along with Bonutti’s base devices (providing a way to position an external energy unit on a skin portion of the body of a patient or adjacent thereto) without redesigning Bonutti’s core delivery path. Because the references address the same engineering problem (providing a way to position an external energy unit on or adjacent to a skin portion of the body of a patient) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (relative placement of an external energy unit on a skin portion of the body of a patient or adjacent thereto), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 10, Bonutti modified by Yurek and Hoffman teaches the medical apparatus of claim 9, as set forth above, for the reasons set forth above.
Bonutti teaches that “[t]he external energy unit is positioned on a skin portion of the body of a patient or adjacent thereto, proximal to the treatment site. The energy signal is non-invasively transmitted through the body of the patient to the medical implant” (¶9).
Bonutti does not expressly teach wherein the manipulator comprises a belt configured for fastening to a human patient.
Hoffman teaches various wearables for the external vibratory devices including belt 130 and central panel 132 (p. 64, lines 20-30; FIG 12). Hoffman also teaches that the variation of engagement means for belt 130 and all variants thereof can be utilized and adapted for any body part and may also be adapted to provide support for other suitable vibrators or other percussion instruments by other names (p. 67, 21-25).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHERIE M POLAND whose telephone number is (703)756-1341. The examiner can normally be reached M-F 9am-6pm (CST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHERIE M POLAND/Examiner, Art Unit 3771
