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 .
Formal Matters
Applicant’s Response filed 30 March 2026 is acknowledged. Claims 16, 18-22 are cancelled. Claims 1, 25, and 27 are currently amended. Claims 1-15, 17, and 23-27 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 March 2026 has been considered by the examiner. A signed copy is attached.
Response to Arguments
Applicant argues that the cited references do not teach or suggest the claims as currently amended (Remarks, numbered p.6). Applicant argues that Bonutti does not disclose a device sized and shaped for deployment into a renal pelvis via a ureteroscope, but rather describes medical device 12 as being “surgically positioned at a treatment site (para. [0037]) (Remarks, numbered p. 6). Applicant argues that the single mention of the kidney at paragraph [0061] “is [a] bare statement of contemplated use with no disclosure of how the device would be sized, shaped, or configured for placement within a renal pelvis” (Remarks, numbered p. 6). Applicant argues that the examiner maps Bonutti’s piezoelectric device 30 (ferromagnetic plate 32, ceramic disk 34) to the claimed “atraumatic turbulence generator”, but that Bonutti’s piezoelectric device 30 is an energy focusing device configured to receive externally transmitted energy and create convergent point shockwaves (para. [0041]) and it is not described as a turbulence generator” (Remarks, numbered p. 6). Applicant argues that Yurek does not disclose an implantable element that resides within the renal pelvis (Remarks, numbered p. 7). Applicant argues that the ranges Bonutti teaches are orders of magnitude above the 150-350 Hz range recited in claim 1 (Response, numbered p. 7). Applicant argues that one of ordinary skill in the art would not have been motivated to select the 150-350 Hz range for the purpose of fragmenting or dislodging renal calculi since the prior art teaches that this range lacks the energy to do so (Remarks, numbered p. 8). Applicant argues that the claimed invention involves generating turbulence in the renal pelvis fluid medium to circulate fluid and reduce stagnation, thereby mitigating stone formation (Remarks, numbered p. 8). Applicant argues that this differs from the therapeutic mechanism from shockwave fragmentation taught in the prior art (Remarks, numbered p. 8). Applicant argues that the frequency range of 150 Hz and 350 Hz is an affirmative recitation that the element generates acoustic waves at this frequency and does not recite that the element passes through this range while ramping to a different frequency (Remarks, numbered p. 8). Applicant argues that dependent claim 17 recite separate and concurrent or additional capabilities, not a transient ramp-up to the “frequencies greater than 20,000 Hz range). Applicant argues that the Office Action’s characterization of the 150-350 Hz range as “merely exemplary” and lacking “criticality” does not negate the fact that neither reference discloses this range for acoustic wave generation by an implanted element (Remarks, numbered p. 8). Applicant traverses the rejections over claims 2, 3, and 9-10, as depending from claim 1 “because no prima facie case of obviousness exists” (Remarks, numbered p. 9).
Applicant’s arguments have been fully considered, but they are not persuasive. Applicant’s amendments to claim 1 are drawn to functional recitations and method steps when the claims are apparatus claims, drawn to a “medical apparatus”. The ability of the atraumatic turbulence generator component of the apparatus to be deployed through a ureteroscope is a functional recitation that is broadly interpreted as a function that the apparatus is capable of performing. Applicant is reminded that the recitation of an element is “capable of” performing a function is not a positive limitation, but only requires the ability to so perform. It does not constitute a limitation in any patentable sense. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed (e.g. “deployable though a ureteroscope”) does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See also, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).
Similarly, the amendments to claim 1 where the atraumatic turbulence generator is “configured to reside within a renal pelvis of a human kidney during a specific period of time” is a functional limitation. The specification does not disclose the criticality of any specific period of time. It is also noted that there is no ipsa verba support for the language “configured to reside within” or “during a specified period of time” in the specification or originally filed claims. The examiner recognizes that mere rephrasing of a passage does not constitute new matter (MPEP 2163.07 and 608.01(o)). The examiner has given Applicant consideration for being their own lexicographer in the amended claims. However, there must still be originally filed support even if alternative comparable language (synonyms) are used. Accordingly, page 8 of the disclosure has been considered in terms of the implantation of the device and the predetermined amount of time for the device to remain within the kidney before removal.
It is the examiner’s position that the capability statement where the device is “deployable through a ureteroscope”, “configured to reside within”, “during a specified period of time”, and “into a naturally occurring fluid within the renal pelvis” does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure taught by Bonutti in view of Yurek, which is capable of performing the intended use of the medical device being “a medical apparatus” and an “atraumatic turbulence generator”, as explained of record and as set forth below.
With regard to Applicant’s argument that Bonutti does not disclosure how the device would be sized, shaped, or configured for placement within a renal pelvis” (Remarks, numbered p. 6), Applicant’s attention is directed to 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). In Gardner, 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.
As explained of record, Bonutti teaches an atraumatic turbulence generator (FIGs 2, 4; ¶41, piezoelectric device 30 ferromagnetic plate 32, ceramic disk 34) sized and shaped to be deployed (FIGs 2, 4; ¶37) into a human kidney (¶61), the atraumatic turbulence generator comprising an acoustic wave generating element for generating an acoustic wave (FIG 4; ¶46) into a medium (¶40). One of ordinary skill in the art would be motivated to utilize the piezoelectric device 30 of Bonutti for treatment of the kidney related to kidney stones (¶61). This express teaching, suggestion, and motivation, is combinable with the express disclosures of Yurek, which teaches devices for minimally invasive kidney stone removal (100) and shockwave lithotripsy, uroscopy, and percutaneous nephrolithotomy as other treatment modalities (¶3) and would motivate a person of ordinary skill in the art to seek devices that can utilize laminar flow and turbulent flow for stone removal in human (FIGs 2A-B; ¶¶160-161) kidneys (¶119). Additionally, Yurek teaches that dynamic irrigation streams may be configured to optimize removal of kidney stones, including in a calyx (¶119). Yurek teaches that the shape, spread, flow rate and/or type of flow is taught as oscillating or otherwise varying along with differential pressure (¶119).
Regarding Applicant’s argument that Bonutti’s piezoelectric device 30 is an energy focusing device configured to receive externally transmitted energy and create convergent point shockwaves and it is not described as a turbulence generator, the name of a device or what one may or may not call a thing, is not a patentable limitation. The structure and associated function of the device is what is considered for patentability. In the instant situation, device 30 of Bonutti is taught as being in-dwelling (residing in the body) and able to be externally activated for therapeutic purposes. Accordingly, although Applicant argues that Yurek does not disclose an implantable element that resides within the renal pelvis (Remarks, numbered p. 7), Yurek need not teach what is taught by Bonutti.
Device 30 of Bonutti is sized, shaped, and configured to be placed into the human kidney. Although this is one of several embodiments taught by Bonutti, the fact that it is affirmatively taught is strongly considered as part of the requirements for the prior art teaching, suggestion, and motivation tests. Additionally, Applicant is advised that the manner of deployment, as recited in amended claim 1, is applicable to a method of use claim, but not to a claim drawn to the device itself (in an apparatus claim), so long as the device it capable of performing the function claimed. Although Bonutti teaches that the device is capable of being “surgically or percutaneously position at a treatment site” (¶7), Yurek teaches use of a ureteroscope (via ureteroscopy) for the fracture and removal of the stones using an endoscope that is introduced through the bladder (¶3). Additionally, Yurek teaches that “traditionally, smaller kidney stones have been treated using other, less invasive techniques including through ureteroscopy” (¶6).
As explained of record, 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 delivered into a renal pelvis of a human kidney. Yurek teaches therapy 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 formation of kidney stones in human patients using laminar and turbulent (atraumatic) flows, would reasonably consult Yurek’s therapeutic minimally invasive solution. Yurek’s fluidic irrigation can be performed with a number of different irrigation devices and incorporated along with Bonutti’s base devices (same location, flow, and frequency interaction) using known treatment devices and methods without redesigning Bonutti’s core device. Because the references address the same engineering problem (using acoustic wave devices to dislodge 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.
With regard to Applicant’s argument that the ranges Bonutti teaches are orders of magnitude above the 150-350 Hz range recited in claim 1 (Response, numbered p. 7) and that one of ordinary skill in the art would not have been motivated to select the 150-350 Hz range for the purpose of fragmenting or dislodging renal calculi since the prior art teaches that this range lacks the energy to do so (Remarks, numbered p. 8), Applicant’s argument is recognized, but it is not persuasive because Yurek expressly teaches therapy 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 formation of kidney stones in human patients using laminar and turbulent (atraumatic) flows, would reasonably consult Yurek’s therapeutic minimally invasive solution. Specifically, as explained of record, Yurek 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). This range overlaps with the claimed ranges of 150Hz to 350Hz and provides evidence that the prior art considered pulsed turbulent flows within this frequency range as being therapeutically beneficial.
Regarding Applicant’s argument that dependent claim 17 recites separate and concurrent or additional capabilities, not a transient ramp-up to the “frequencies greater than 20,000 Hz range), Applicant’s argument has been fully considered, but it is not persuasive. 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 may be an additional range in claim 17, but the claimed device (apparatus claim) still must be capable of performing the frequency ranges as claimed, both in the independent recitation of claim 1 and the dependent “further produces” frequency range of claim 17. Accordingly, the “use” of the device for turbulent flow at a lower frequency (“150Hz to 350 Hz”) range or “use” 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. 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). 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 which 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 – Maintained and New - Necessitated by Amendment
New Claim Rejections – Necessitated by Amendment
Claim Rejections - 35 USC § 112
Claims 1-15, 17, and 23-27 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.
Claim 1 has been amended to recite that the atraumatic turbulence generator is sized and shaped to be “deployable through a ureteroscope configured to reside within a renal pelvis of a human kidney during a specified period of time.” The amendment renders the claim unclear and confusing. The claim, as written, reads on the ureteroscope being configured to reside within a renal pelvis of a human kidney during a specified period of time”. There is no punctuation or other textual separation between the two devices of lines 3-4 of claim 1, such that it is unclear whether it is the atraumatic turbulence generator or the ureteroscope which is configured to reside within a renal pelvis of a human kidney during a specified period of time. Yurek et al., cited of record teaches that 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 is unclear and confusing whether Applicant’s amendments apply to an undisclosed specific period of time it takes to remove kidney stones and fragments from the body using the ureteroscope or whether the deployment of an atraumatic turbulence generator (e.g. a flow generator, such as that taught by Yurek at ¶83) is configured to reside in the renal pelvis of a human kidney during a specified period of time.
Applicant is referred to Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (2008). A five member expanded panel of the Board held that "if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 USC 112, second paragraph, as indefinite." Applicant is also referred to Nautilus Inc., v. Biosig Instruments, Inc., 572 U.S. 898, 908-909 (2014) in which the Court held that a claim is indefinite if the specification and prosecution history fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention. The Court also held that a patent must be precise enough to afford clear notice of what is claimed thereby "appris[ing] the public of what is still open to them (citing Markman v. Westview Instruments, Inc., 517 U.S. 370, 373 (1996)), in a manner that avoids "[a] zone of uncertainty which enterprise and experimentation may enter only at the risk of infringement claims," (citing United Carbon Co., v. Binney & Smith Co., 317 U.S. 228, 236 (1942)) (Nautilus 909). Claims 2-15, 17, and 23-27 are rejected as depending from a rejected claim.
Claim Rejections 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) (previously cited of record), 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) sized and shaped to be deployable (FIGs 2, 4; ¶37) into a human kidney (¶61), the atraumatic turbulence generator comprising an acoustic wave generating element for generating an acoustic wave (FIG 4; ¶46) into a medium (¶40) 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 that a frequency within a range of 150 Hz and 350 Hz, specific location within the kidney (¶61) is within the renal pelvis, or to dislodge or fragment renal calculi within a calyx.
Bonutti does not expressly teach that the atraumatic turbulence generator is deployable through a ureteroscope configured to reside within a renal pelvis of a human kidney during a specified period of time.
Bonutti does not expressly teach that the acoustic wave generator creates turbulence in a naturally occurring fluid within the renal pelvis, but does teach the use of an acoustic wave generator in the kidney to aid in the breaking-up or fragmenting of kidney stones (¶61). Yurek teaches devices for minimally invasive kidney stone removal (100). Removal device 100 is taught as removing a kidney stone from a calyx into a renal pelvis (¶135; FIG 2B) using irrigation and suctioning. Shockwave lithotripsy (using ultrasound waves to fracture stones), uroscopy (fracture and removal of stones using an endoscope), and percutaneous nephrolithotomy are taught as other treatment modalities at ¶3. Laminar flow and turbulent flow for stone removal in human (FIGs 2A-B; ¶¶160-161) kidneys are taught at ¶119. The shape, spread, flow rate and/or type of flow is taught as oscillating or otherwise varying along with differential pressure where pulses of irrigation fluid are 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 during a specified period of time (“the ureteroscope may be used repeatedly until clinically significant kidney stones and kidney stone fragments are broken up and removed from the body”, ¶6).
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). Bonutti also 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. Additionally, the specification does not teach the criticality of the 150 Hz and 350 Hz range.
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 important. There is no benefit for the medical apparatus to operate in that range. There is no criticality for the medical apparatus to operate in that range. There is no unexpected result by the medical apparatus operating in that range.
As taught by Yurek sonic frequency ranges of 150 Hz and 350 Hz are generally regarded as providing a fluidic or laminar flow within a medium of a human kidney. 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). In this regard, Applicant’s recitation of 150 Hz and 350 Hz is broadly interpreted as being sufficient to create laminar and fluidic flow, but alone are not sufficiently energetic to fragment renal calculi. Accordingly, given that claim 17 is also dependent on claim 1, the range of 150 Hz and 350 Hz is broadly interpreted as a pass-through range where the ultimate goal is to reach 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).
Bonutti and Yurek teach in the same field of endeavor, that of devices and methods of kidney stone removal. Although, 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, 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). Because Yurek teaches the same therapy 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 formation of kidney stones in human patients using laminar and turbulent (atraumatic) flows, would reasonably consult Yurek’s therapeutic minimally invasive solution. Yurek’s fluidic irrigation can be performed with a number of different irrigation devices and incorporated along with Bonutti’s base devices (same location, flow, and frequency interaction) using known treatment devices and methods without redesigning Bonutti’s core delivery path. 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.
Applicant is also advised that MPEP 2114 applies to the recitation in claim 1 “to dislodge or fragment renal calculi within a calyx of the human kidney”. This phrase is interpreted as intended use language indicating that the structure merely be “capable of” being used in this manner. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed (e.g. “deployable through a ureteroscope”, “configured to reside within a renal pelvis of a human kidney during a specified period of time”, or “to dislodge or fragment renal calculi within a calyx of the human kidney”) does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). See also, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). It is the examiner’s position that the capability statement where the device is “to dislodge or fragment renal calculi within a calyx of the human kidney” does not result in a structural difference between the presently claimed invention and the prior art. Using the device in the specific areas of the kidney do not differentiate from the prior art apparatus when the prior art otherwise teaches all the structural elements of the claim.
Similarly, the amended recitation of generating an acoustic wave “in a naturally occurring fluid within the renal pelvis” is a recitation of a functional element that only requires that the device have the ability to so perform. It does not constitute a limitation in any patentable sense. See In re Hutchison, 69 USPQ 138, 33 CCPA 879 (1946). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed (e.g. “generating an acoustic wave into a naturally occurring fluid within the renal pelvis”) does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original).
It is the examiner’s position that the capability statement where the device is “deployable through a ureteroscope”, “configured to reside within”, “during a specified period of time”, and “into a naturally occurring fluid within the renal pelvis” does not result in a structural difference between the presently claimed invention and the prior art and further that the prior art structure taught by Bonutti in view of Yurek, which is capable of performing the intended use of the medical device being “a medical apparatus” and an “atraumatic turbulence generator”, as explained of record and as set forth below.
With regard to Applicant’s argument that Bonutti does not disclosure how the device would be sized, shaped, or configured for placement within a renal pelvis” (Remarks, numbered p. 6), Applicant’s attention is directed to 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). In Gardner, 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.
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 medium 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 medium (¶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)) (previously cited of record), 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)) (previously cited of record), 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, wherein the acoustic wave generating element comprises:
a chassis (Bonutti: FIG 4, external energy unit 56; ¶49 of Bonutti, exemplary shockwave generators, incorporated by reference to Rattner, claim 1, housing);
an electric motor (Bonutti: ¶49, exemplary shockwave generators, incorporated by reference to Rattner (column 2, line 43), electric motor 12, electric motor 20; Rattner claim 6).
Bonutti 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 (Uber: ¶70). Uber 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).
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) (previously cited of record), 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)) (previously cited of record) and also in view of 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, wherein the element comprises:
A chassis (Bonutti: FIG 4, external energy unit 56; ¶49 of Bonutti, exemplary shockwave generators, incorporated by reference to Rattner, claim 1, housing);
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).
Bonutti, Yurek, Uber, and Hoffman teach in the same field of endeavor, energy assisted medical devices. Bonutti and Yurek teach as set forth above. Bonutti and Uber, incorporate by reference, 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) (previously cited of record), 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) (previously cited of record), 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. 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 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).
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.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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).
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/CHERIE M POLAND/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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