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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 16 May 2026 is acknowledged. The traversal is on the ground(s) that Hirt US 20020010486 does not teach the through-opening in the vibratory excitatory element. This is not found persuasive because ¶14 of Hirt expressly teaches that “axial through-bore 18 is axially aligned with the hollow of the metallic probe or sonotrode 8. Bore 18 is dimensioned so that it accommodates impact probe 20 which is passed through the hollow of sonotrode 8”.
The requirement is still deemed proper and is therefore made FINAL.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 16 May 2026.
Priority
The application is a National Stage Application filed under 35 USC 371 of PCT/EP2022/083659 (29 November 2022) that claims foreign priority to DE 102021131669.3 (1 December 2021).
A copy of the foreign priority document, in the German language, has been received. No English language translation has been provided to date.
Formal Matters
Claims 1-16 are pending. Claim 15 is withdrawn with traverse. Claims 1-13 and 16 are currently amended. Claims 1-14 and 16 are under examination.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is 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 13 recites the limitation "the lithotripsy system" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 13 was originally written as an independent claim drawn to a lithotripsy system with an internal dependency on the device of claim 1. However, the amendment filed 16 May 2026 amended the leading English language article “A” to a “The” rendering the claim dependent on claim 1, which does not recite a lithotripsy system, but rather is directed to a lithotripsy device.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hirt et al., US 20020010486 (24 January 2002).
Regarding claim 1, Hirt teaches a lithotripsy device for fragmenting body stones (FIGs 1, 2), the lithotripsy device comprising:
a hand-held device (FIG 1);
an ultrasonic vibration exciter with an ultrasonic vibration exciter outer diameter (FIG 1, mass body 21);
a sonotrode (8) with a longitudinal central axis and a sonotrode outer diameter, which can be connected to the hand-held device on the distal side (FIG 1),
wherein the sonotrode can be excited to a first vibration by means of the ultrasonic vibration exciter (¶14); and
a vibration excitation element with a through-opening (FIG 2, impact probe 20; ¶15),
wherein the vibration excitation element (20) with the through-opening (18) is arranged around the sonotrode (8) outer diameter and/or around the ultrasonic vibration exciter outer diameter (FIG 1), wherein the through-opening (18) of the vibration excitation element (20) has a larger diameter than the sonotrode outer diameter (FIG 1) and/or than the ultrasonic vibration exciter outer diameter (FIG 1) so that the vibration excitation element (20) is freely movable (FIG 1, flexible ¶14; claim 2), and the vibration excitation element (20) has an imbalance (impact member or projectile 22) so that, in the event of a rotation of the vibration excitation element (20) about the sonotrode (8) and/or the ultrasonic vibration exciter (20; claim 2), the sonotrode (8) can be excited to a second vibration by means of the imbalance (¶15, reversible drive).
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 1-7, 10-13, and 16 are rejected under 35 U.S.C. 103 as being obvious over Bond et al., US 20140371636 (18 December 2014).
Regarding currently amended claim 1, Bond teaches a lithotripsy device (claim 1) for fragmenting body stones (¶¶1, 98), the lithotripsy device (reference figures encompass device of FIGs 12A-B through embodiments of FIGs 13-16G) comprising:
a hand-held device (FIGs 1, 12A, housing 18e);
an ultrasonic vibration exciter (transducer 10f, ¶101) with an ultrasonic vibration exciter outer diameter (FIGs 16A-G; ¶101);
a sonotrode (waveguide tube 32f), with a longitudinal central axis (FIG 13, central axis 58f) and a sonotrode (waveguide tube 32f) outer diameter (FIGs 16A-G; ¶101), which can be connected to the hand-held device on the distal side (FIGs 12A-B), wherein the sonotrode (32f) can be excited to a first vibration (¶101) by means of the ultrasonic vibration exciter (10f); and
a vibration excitation element with a through-opening (shock pulsing mass 48f; ¶100),
wherein the vibration excitation element with the through-opening (48f) is arranged around the sonotrode outer diameter and/or around the ultrasonic vibration exciter outer diameter (FIGs 16A-G; ¶101),
wherein the through-opening of the vibration excitation element (48f) has a larger diameter than the sonotrode outer diameter and/or than the ultrasonic vibration exciter outer diameter (FIGs 16A-G; ¶101) so that the vibration excitation element (48f) is freely movable, and
the vibration excitation element (48f) has an imbalance (FIGs 15A-B, 16A-G, divot 67f, ¶99; wobble ¶101; wagging ¶102) so that, in the event of a rotation of the vibration excitation element (48f) about the sonotrode (32f) and/or the ultrasonic vibration exciter (10f), the sonotrode (32f) can be excited to a second vibration (oscillation, wobble ¶101; wagging ¶102) by means of the imbalance (67f).
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 the multiple embodiments of Bond given that the prior art reference as a whole included each element claimed, although not necessarily in a single embodiment. The multiple embodiments in Bond provide a teaching, suggestion, or motivation in the reference itself, as a whole, and in the knowledge generally available to one of ordinary skill in the art, to combine reference teachings with a reasonable expectation of success. The claimed invention would have been obvious because a person of ordinary skill in the art would have been motivated to combine teachings within the four corners of a reference to achieve the claimed invention with a reasonable expectation of success. Bond teaches different embodiments each solving known problems in the art, including ultrasonic transducers (10), ultrasonic wave guides (24), shock-pulsing masses with through-openings in single and multiple forms (48). One of ordinary skill in the art would be motivated to select among the various embodiments of Bond given that Bond does not show every embodiment in the Figures, but provides a reference device embodiment comprising a handle at FIGs 12A-B and component parts more specifically represented by FIGs 13-16G. One would have a reasonable expectation of success in selecting from the finite embodiments taught by Bond given that Bond expressly teaches that the various embodiments represent ways to maximize the performance of ultrasonic transducers by manipulating the locations of various components to take advantage of the vibrations of the ultrasonic waveguide (¶82). Bond also expressly discloses that some reference numerals are used to designate the same or corresponding parts through several of the embodiments and that corresponding parts are denoted with the addition of lowercase letters (¶67). Bond expressly discloses that “[i]t will be understood that variations in the embodiment can generally be interchanged without deviating from the invention.” (¶67).
The phrase “can be” in lines 5, 6, and 15 is broadly interpreted as “capable of” language.
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).
Regarding currently amended claim 2, Bond teaches the lithotripsy device according to claim 1, as set forth above , for the reasons set forth above.
Bond teaches wherein the vibration excitation element (48f) is disc-shaped, annular, hollow-cylinder-shaped, and/or toroidal (FIGs 15A-B, 16A-G).
Regarding currently amended claim 3, Bond teaches the lithotripsy device according to claim 1, as set forth above, for the reasons set forth above.
Bond teaches wherein the vibration excitation element (48f) has an axis of rotation deviating from the longitudinal central axis (FIG 12A) and/or deviating from a main axis of inertia (FIGs 16A-G).
Regarding currently amended claim 4, Bond teaches the lithotripsy device according to claim 1, as set forth above, for the reasons set forth above.
Bond teaches wherein the vibration excitation element (48f) comprises an imbalance element (FIGs 15A-B, 16A-G, divot 67f, ¶99; wobble ¶101; wagging ¶102) in a vibration excitation element interior and/or on a vibration excitation element outer surface (FIGs 15A-B, 16A-G; ¶99).
Regarding currently amended claim 5, Bond teaches the lithotripsy device according to claim 1, as set forth above, for the reasons set forth above.
Bond teaches wherein the vibration excitation element (48f) has a recess (FIGs 15A-B, 16A-G, divot 67f, ¶99).
Regarding currently amended claim 6, Bond teaches the lithotripsy device according to claim 4, as set forth above, for the reasons set forth above.
Bond teaches wherein the imbalance element (FIGs 15A-B, 16A-G, divot 67f, ¶99; wobble ¶101; wagging ¶102) is arranged on a distal side and/or a proximal side of the vibration excitation element (48f).
Regarding currently amended claim 7, Bond teaches the lithotripsy device according to claim 1, as set forth above, for the reasons set forth above.
Bond teaches further comprising a drive apparatus (actuator 12e; ¶97) for driving the rotation of the vibration excitation element (48f).
Regarding currently amended claim 10, Bond teaches the lithotripsy device according to claim 1, as set forth above, for the reasons set forth above.
Bond teaches the device further comprising an attachable holder housing (FIGs 12A-B, nosecone 50e; ¶97), wherein the attachable holder housing (50e) surrounds the vibration excitation element (48f), a proximal end of the sonotrode (32f) and/or the ultrasonic vibration exciter (10f).
Regarding currently amended claim 11, Bond teaches the lithotripsy device according to claim 10, as set forth above, for the reasons set forth above.
Bond teaches wherein the attachable holder housing (50e; ¶97) internally has a proximal stop and/or a distal stop (FIGs 12A-B, stop 42e; ¶¶71, 97) for limiting a movement path of the vibration excitation element (48f) along the longitudinal central axis (FIG 12A) of the sonotrode (32f) and/or an inlet opening and an outlet opening for the compressed gas flow.
Regarding currently amended claim 12, Bond teaches the lithotripsy device according to claim 11, as set forth above, for the reasons set forth above.
Bond teaches wherein a spacer element (waveguide fitting 28e) is arranged between the proximal stop (¶97) and the vibration excitation element (48f) and/or between the vibration excitation element (48f) and the distal stop (¶97).
Regarding currently amended claim 13, Bond teaches the lithotripsy system [sic] for fragmenting body stones, the lithotripsy system comprising a lithotripsy device according to claim 1, as set forth above, for the reasons set forth above.
Bond teaches a plurality (¶6; claim 13) of vibration excitation elements (48f) with a relevant imbalance (FIGs 15A-B, 16A-G, divot 67f, ¶99; wobble ¶101; wagging ¶102), and/or a plurality of sonotrodes (32f).
Regarding currently amended claim 16, Bond teaches the lithotripsy device according to claim 5, as set forth above, for the reasons set forth above.
Bond teaches wherein the recess is arranged on a distal side and/or a proximal side of the vibration excitation element (48f).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Bond et al., US 20140371636 (18 December 2014) in view of Hirt et al., US 20020010486 (24 January 2002).
Regarding currently amended claim 8, Bond teaches the lithotripsy device according to claim 7, as set forth above, for the reasons set forth above.
Bond teaches wherein the drive apparatus (actuator 12e; ¶97).
Bond does not teach a nozzle for effecting a compressed gas flow on the vibration excitation element.
Hirt teaches a lithotripter device comprising a sonotrode 8, as set forth above, driven by a pneumatic design (¶15) comprising pressure chamber 27 and a nozzle (inlet duct 28) for compressed air (¶16; claim 13).
Hirt also teaches that impact member 22 may be driven pneumatically, hydraulically or electromagnetically (¶15).
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 Bond and Hirt, given that the prior art included each element claimed, although not necessarily in a single reference.
Bond and Hirt teach in the same field of endeavor comprising lithotripter medical-technical devices.
Although, Bond discloses the claimed base device comprising an actuator drive, Bond does not disclose that the drive is pneumatic.
Hirt specifically addresses different drive systems and expressly states that may be driven by a piezoelectric drive system, or pneumatically, hydraulically or electromagnetically (¶15).
Both Hirt’s and Bond’s primary drive system is a piezoelectric drive (Hirt, ¶14; Bond, ¶97). Hirt teaches a reversible drive of the impact member or projective or projectile 22 is preferably of a pneumatic design, but may also be driven hydraulically or electromagnetically (¶15). A person of ordinary skill in the art, seeking differential device control through drive mechanisms would reasonably consult Hirt’s additional pneumatic drive solution using known assembly methods without redesigning Bond’s waveguide. A person of ordinary skill in the art attempting to render Bond’s piezoelectric drive lithotripter device compatible with different or additional drive systems, including a reversible drive system, would look for established drive systems and designs to avoid creating a novel drive system. Hirt’s drive system is a modular component and can be adapted to the waveguide of Bond’s device.
Because the references address the same engineering problem (drive actuation in lithotripter devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting a known drive system for another known drive system in the same type of device), 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 currently amended claim 9, Bond teaches the lithotripsy device according to claim 8, as set forth above, for the reasons set forth above.
Bond teaches wherein the vibration excitation element has a groove in a lateral surface (FIGs 15A-B, 16A-G, divot 67f, ¶99).
Bond does not teach the groove is for effecting the compressed gas flow.
Hirt teaches a lithotripter device comprising a sonotrode 8, as set forth above, and comprising a driven by a pneumatic design (¶15) comprising pressure chamber 27 and a nozzle (inlet duct 28) for compressed air (¶16; claim 13).
Hirt also teaches that impact member 22 may be driven pneumatically, hydraulically or electromagnetically (¶15) and is axially adjustable relative to the sonotrobe (claim 2).
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 Bond and Hirt, given that the prior art included each element claimed, although not necessarily in a single reference.
Bond and Hirt teach in the same field of endeavor comprising lithotripter medical-technical devices.
Although, Bond discloses the claimed base device comprising an actuator drive, Bond does not disclose that the drive is pneumatic.
Hirt specifically addresses different drive systems and expressly states that may be driven by a piezoelectric drive system, or pneumatically, hydraulically or electromagnetically (¶15).
Both Hirt’s and Bond’s primary drive system is a piezoelectric drive (Hirt, ¶14; Bond, ¶97). Hirt teaches a reversible drive of the impact member or projective or projectile 22 is preferably of a pneumatic design, but may also be driven hydraulically or electromagnetically (¶15). A person of ordinary skill in the art, seeking differential device control through drive mechanisms would reasonably consult Hirt’s additional pneumatic drive solution using known assembly methods without redesigning Bond’s waveguide. A person of ordinary skill in the art attempting to render Bond’s piezoelectric drive lithotripter device compatible with different or additional drive systems, including a reversible drive system, would look for established drive systems and designs to avoid creating a novel drive system. Hirt’s drive system is a modular component and can be adapted to the waveguide of Bond’s device.
Because the references address the same engineering problem (drive actuation in lithotripter devices) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (substituting a known drive system for another known drive system in the same type of device), 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 14 is rejected under 35 U.S.C. 103 as being unpatentable over Bond et al., US 20140371636 (18 December 2014) in view of Wolfgang et al., US 30030097229 (22 May 2003).
Regarding independent claim 14, Bond teaches a lithotripsy device (claim 1; reference figures encompass device of FIGs 12A-B through embodiments of FIGs 13-16G), wherein the lithotripsy device has a sonotrode (32f)and an ultrasonic vibration exciter (transducer 10f), comprising:
at least one vibration excitation element (48f) with an imbalance (FIGs 16A-G, wobble ¶101) and with a through-opening (FIGs 15A-B, 48f) for sliding onto the sonotrode (32f);
a drive apparatus (actuator 12e; ¶98) for effecting a rotation of the vibration excitation element (48f), and/or an attachable holder housing for surrounding the vibration excitation element (FIGs 12A-B, nosecone 50e, ¶97), a proximal end of the sonotrode (32f) and/or the ultrasonic vibration exciter (transducer 10f), to form a lithotripsy device comprising the ultrasonic vibration exciter (10f) with an ultrasonic vibration exciter outer diameter (FIGs 16A-G; ¶101); and
the sonotrode (waveguide tube 32f), with a longitudinal central axis (FIG 12A) and a sonotrode outer diameter (FIGs 16A-G; ¶101),
wherein the sonotrode (32f) can be excited to a first vibration by means of the ultrasonic vibration exciter (10f),
wherein the vibration excitation element has a through-opening (48f) and wherein the vibration excitation element with the through-opening (48f) is arranged around the sonotrode outer diameter and/or around the ultrasonic vibration exciter outer diameter (FIGs 16A-G; ¶101),
wherein the through-opening of the vibration excitation element (48f) has a larger diameter than the sonotrode outer diameter and/or than the ultrasonic vibration exciter outer diameter (FIGs 16A-G; ¶101) so that the vibration excitation element (48f) is freely movable (FIGs 16A-G; ¶101), and
the vibration excitation element (48f) has an imbalance (FIGs 15A-B, 16A-G, divot 67f, ¶99; wobble ¶101; wagging ¶102) so that, in the event of a rotation of the vibration excitation element (48f) about the sonotrode (32f) and/or the ultrasonic vibration exciter (10), the sonotrode (32f) can be excited to a second vibration (oscillation, wobble ¶101; wagging ¶102). by means of the imbalance (67f).
Bond does not teach a retrofitting kit for retrofitting a medical device.
Wolfgang teaches replacement parts and retrofits for medical-technical devices (¶9). The medical-technical device as lithotripters are taught at ¶17.
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 Bond and Wolfgang, given that the prior art included each element claimed, although not necessarily in a single reference.
Bond and Wolfgang teach in the same field of endeavor comprising lithotripter medical-technical devices.
Although, Bond discloses the claimed base lithotripter device, Bond does not teach retrofitting kit for retrofitting a medical device. Wolfgang expressly discloses using replacement parts and retrofits for medical-technical devices (¶9) and calibration thereof. The medical-technical device as lithotripters are taught at ¶17. Because Bond’s device includes modular components that are known to wear over time (¶137), a person of ordinary skill in the art seeking to address problems with worn lithotripter devices would look to Wolfgang’s retrofit solution. Wolfgang’s retrofit solution is modular and can be incorporated alongside Bond’s device using known assembly methods and the same or suitable replacement parts without redesigning Bond’s device. A person of ordinary skill in the art attempting to provide solutions for the known problems of device wear in the art, as expressly taught by Bond (¶¶137-139) would look for established solutions to avoid creating a novel device. Wolfgang’s solution and calibration procedures are modular and can be adapted to the lithotripter device of Bond to enable device repair and retrofitting.
Because the references address the same engineering problem (lithotripter device wear and replacement or retrofitting) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (replacing parts or retrofitting and calibrating the device), 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.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Gloggler et al., US 20240197344 (20 June 2024) teaches holding deice for a lithotripsy device, and lithotripsy device for fragmenting calculi.
Huber et al., US 20250017607 (16 January 2025) teaches lithotripsy device, in particular intracorporeal lithotripsy device, for breaking up calculi, impact element, retrofitting set for retrofitting an existing lithotripsy deice, and method for operating a lithotripsy device.
Hinding, US 20240197343 (20 June 2024) teaches ultrasonic generator for supplying an electrical power, lithotripsy device for fragmenting calculi, and method for operating and/or controlling a lithotripsy device.
Huber et al., US 20250268616 (28 August 2025) teaches lithotripsy device for breaking up calculi with an axially moveable acceleration tube, and method for accelerating a projectile of a lithotripsy device.
Hinding et al., US 20230293194 (21 September 2023) teaches method for determining an optimal frequency of an oscillating movement of a force-accelerated projectile of an intracorporeal lithotripsy apparatus.
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
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