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 without traverse of claims 1-17 in the reply filed on 2/10/26 is acknowledged.
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 7 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 7 recites “about 20 kHz to about 150 kHz,” however the specification does not provide guidance as to the tolerance of the range.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-6, 8-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hare et al. [US 2005/0267488 A1, hereinafter “Hare”] in view of Pikus et al. [US 2015/0105715 A1, hereinafter “Pikus”].
Re. claim 1, Hare discloses a lithotripsy device [11, Fig. 1] comprising:
a longitudinal shaft [63] extending between a proximal portion [31] and distal portion [24];
a basket [struts/tines 65, taken together] extending along the distal portion of the longitudinal shaft [Fig. 1], the basket configured to catch a target calculus [Par. 0013]; wherein at least one of the longitudinal shaft and the basket is configured to vibrate in response to an acoustic energy input [“a transverse ultrasonic vibration is created along the longitudinal axis of the ultrasonic probe 15. In a preferred embodiment of the present invention, the ultrasonic probe 15 including the wire body 63 and the plurality of tines 65 vibrate,” Par. 0085].
Hare discloses rotating the probe to surround the stone within the tines [see claim 42] but fails to explicitly teach a rotational driver operably coupled to the longitudinal shaft and the basket, the rotational driver actuatable for rotating the longitudinal shaft and the basket. However, Pikus teaches in a medical device with a shaft and basket, a rotational driver [drive shaft, Par. 0055] operably coupled to the longitudinal shaft and the basket, the rotational driver actuatable for rotating the longitudinal shaft and the basket [Par. 0055]. Adding a rotational driver which rotates the shaft and basket would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, because this allows the basket to be readily rotated either automatically or by some actuator, allowing for easier and more controlled rotation which allows the basket to be positioned as desired and as taught by Hare.
Re. claim 2, Hare discloses at least one acoustic transducer that is acoustically coupled to at least one of the longitudinal shaft or the basket [“transducer within the handle 88… transmits the ultrasonic energy to the ultrasonic probe 15,” Par. 0054].
Re. claim 3, Hare discloses acoustic generator [99] operably coupled to the acoustic transducer, the acoustic generator actuatable for producing an acoustic waveform [Par. 0067].
Re. claim 4, Hare discloses the basket is acoustically-transmissive [the tines vibrate in response to the acoustic waves, Par. 0085].
Re. claim 5, Hare discloses the basket comprises nitinol or titanium [titanium, Par. 0062].
Re. claim 6, Hare is silent regarding a plurality of acoustic transducers located on the basket. However, Pikus teaches a basket comprising a plurality of acoustic transducers thereon [“the expandable basket 212 may include one or more…transducers disposed along the struts,” Par. 0047]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hare to include transducers located on the basket as taught by Pikus in order to cause further vibration in the basket.
Re. claim 8, Hare discloses the longitudinal shaft comprises nitinol or titanium [titanium, Par. 0062].
Re. claim 9, selecting the above-modified rotational driver to be manual would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this allows a user greater control over the rotation.
Re. claim 10, selecting the above-modified rotational driver to be automatic would have been obvious to one of ordinary skill in the art before the effective filing date of the invention because this amounts to automating a manual activity.
Re. claim 11, Hare discloses the basket comprises a proximal end configured to vibrate according to a waveform [Par. 0085, where the waveform is that transmitted by the transducer].
Re. claim 12, Hare discloses the basket is configured to vibrate with a waveform [Par. 0085, where the waveform is that transmitted by the transducer].
Re. claim 13, Hare discloses the longitudinal shaft is configured to vibrate with a waveform [Par. 0085, where the waveform is that transmitted by the transducer].
Re. claim 14, Hare discloses an ultrasonic probe [11, Fig. 1] comprising:
a longitudinal shaft [63] extending between a proximal portion [31] and distal portion [24];
a basket [struts/tines 65, taken together] extending along the distal portion of the longitudinal shaft [Fig. 1], the basket configured to catch a target calculus [Par. 0013];
a transducer [Par. 0054] acoustically coupled to the shaft and the basket [Par. 0085, the transducer configured to produce an ultrasonic waveform [Par. 0054, 0084-0085]
wherein the basket is configured to vibrate in response to an acoustic energy input [“a transverse ultrasonic vibration is created along the longitudinal axis of the ultrasonic probe 15. In a preferred embodiment of the present invention, the ultrasonic probe 15 including the wire body 63 and the plurality of tines 65 vibrate,” Par. 0085].
Hare discloses rotating the probe to surround the stone within the tines [see claim 42] but fails to explicitly teach a rotational driver operably coupled to the longitudinal shaft and the basket, the rotational driver actuatable for rotating the longitudinal shaft and the basket. However, Pikus teaches in a medical device with a shaft and basket, a rotational driver [drive shaft, Par. 0055] operably coupled to the longitudinal shaft and the basket, the rotational driver actuatable for rotating the longitudinal shaft and the basket [Par. 0055]. Adding a rotational driver which rotates the shaft and basket would have been obvious to one of ordinary skill in the art before the effective filing date of the invention, because this allows the basket to be readily rotated either automatically or by some actuator, allowing for easier and more controlled rotation which allows the basket to be positioned as desired and as taught by Hare.
Re. claim 15, Hare discloses the transducer is in the handle. However, Pikus teaches the transducer is on the shaft [Par. 0040]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the apparatus of the modified Hare such that the transducer is on the shaft as taught by Pikus because this amounts to a simple rearrangement of parts which does not affect the function of the device [the transducer located in the handle or on the shaft will cause the shaft/basket to vibrate].
Re. claim 16, Hare discloses the invention substantially as set forth with respect to claim 13 above.
Re. claim 17, Hare-Pikus discloses the invention substantially as set forth with respect to claim 6 above.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hare view of Pikus, as applied to claim 1, and further in view of St. George [US 2014/0121673 A1]
Re. claim 7, Hare-Pikus discloses the invention as set forth above, including the acoustic transducer is configured to propagate a waveform down the longitudinal shaft [Hare Par. 0085] but Hare is silent regarding the frequency range of the ultrasonic waveform. However, St George teaches, in a lithotripsy device, the acoustic transducer is configured to propagate a waveform of greater than 20 kHz down the longitudinal shaft [“In the case of ultrasonic driving power, the frequency of operation would be greater than 20 kHz,” Par. 0054]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the invention of the modified Hare such that the transducer propagates a wave with a frequency of greater than 20 kHz in order to “reduce the discomfort from excessive audible noise,” St. George Par. 0054. In the case of overlapping ranges, a prima facie case of obviousness exists. See MPEP 2144.05.I.
Conclusion
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/ERIN MCGRATH/ Primary Examiner, Art Unit 3771