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 .
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.
Claims 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al. (US 2018/0304053) in view of Brisken et al. (US 6,296,619) and further in view of Rabiner et al. (US 2004/0097996).
Regarding claim 1, Eggert discloses an ultrasound medical device (see Fig. 1-5), comprising: an elongate shaft (16) having a distal end region; a first ultrasound transducer coupled to the shaft; and a second ultrasound transducer coupled to the shaft (there are a plurality of force transmitting member 26 ); wherein the first ultrasound transducer is configured to generate a first ultrasound wave; wherein the second ultrasound transducer is configured to generate a second ultrasound wave (the transducers can be activated to produce ultrasonic waves directed towards the target region, see [0043] and [0044]).
Eggert fails to teach the first ultrasound wave constructively interferes with the second ultrasound wave to generate a localized pressure wave in order to transmit energy to a target region and a housing coupled to the elongate shaft.
Brisken, in the same field of art, teaches a related ultrasound medical device (see Fig. 23), including first and second ultrasound transducers (20) which are arranged to constructively interfere with one another, which enhances the effectiveness of the ultrasound delivery (see col. 6, lines 24-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Eggert by causing the first ultrasound wave to constructively interfere with the second ultrasound wave, as taught by Brisken, since doing so would have enhanced the effectiveness of the ultrasound delivery.
The combination of Eggert and Brisken fails to teach a housing coupled to the elongate shaft.
Rabiner, in the same field of art, teaches a related ultrasound medical device (see Fig. 10A-10B and [0029]) including an elongate shaft (22) and a sheath (121, see Fig. Fig. 121) coupled to the elongate shaft for modulating the energy applied to the target tissue (see [0010]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Eggert and Brisken to include a housing, as taught by Rabiner, since doing so would have provided a means for modulating the energy applied to target tissue.
In the device of Eggert as modified by Rabiner, the housing would be coupled to both the elongate shaft and the transducers by virtue of each component being a part of the same device.
Regarding claim 2, the combination of Eggert, Brisken and Rabiner teaches the ultrasound device of claim 1, wherein the first ultrasound transducer and the second ultrasound transducer are positioned within the housing (Rabiner teaches enclosing the energy transmitting portion of a medical device in a sheath, see [0010] and Fig. 10A).
Regarding claim 3, the combination of Eggert, Brisken and Rabiner teaches the ultrasound device of claim 2, wherein the housing includes a first housing member and a second housing member, and wherein the first housing member is configured to attach to the second housing member in a clamshell configuration (Rabiner discloses the sheath 121 may have the configuration shown in Fig. 3E, which shows the sheath 121 being formed of two halves attached to each other in a clamshell configuration).
Regarding claim 4, the combination of Eggert, Brisken and Rabiner teaches the ultrasound device of claim 3, wherein the housing member includes a first aperture, and wherein the aperture is positioned between the first ultrasound transducer and the second ultrasound transducer (sheath 121 may has apertures between the first and second halves of the sheath, see Fig. 3E of Rabiner, and the sheath of Rabiner in the device of Eggert would have an aperture positioned between at least one pair of the transducers extending along the distal end of the device).
Regarding claim 5, the combination of Eggert, Brisken and Rabiner teaches the ultrasound device of claim 4, wherein the transmitted energy is configured to pass through the aperture (openings in sheath 121 are configured to allow the passage of cavitation energy, see [0021] of Rabiner).
Regarding claim 6, Eggert further teaches a third ultrasound transducer and a fourth ultrasound transducer, and wherein the first ultrasound transducer and the second ultrasound transducer form a first pair of ultrasound transducers, wherein the third ultrasound transducer and the fourth ultrasound transducer form a second pair of ultrasound transducers (there are six transmitting members 26 shown in Fig. 1).
Regarding claim 7, Eggert further teaches the first pair of ultrasound transducers are longitudinally aligned with the second pair of ultrasound transducers (see Fig. 1).
Regarding claim 8, the combination of Eggert, Brisken and Rabiner teaches the ultrasound medical device of claim 1. Eggert further teaches a balloon (18) coupled to the elongate shaft (see Fig. 1), and wherein the balloon is designed to shift between a first unexpanded configuration (see Fig. 3) and an expanded configuration (see Fig. 4) wherein the balloon is in contact with the target region. The combination of Eggert, Brisken and Rabiner teaches wherein the housing is positioned underneath the balloon since Rabiner teaches providing the sheath around the energy transmitting portion of the device (see Rabiner [0010] and Fig. 10A).
Regarding claim 9, Eggert further teaches the balloon is configured to be expanded by an inflation media, and wherein the generation of the pressure wave further includes the generation of a bubble within the inflation media (the balloon is necessarily inflated by some inflation media to move to the expanded configuration and the activation of the force transmitting members causes cavitation within the balloon, see [0017] and [0050]).
Regarding claim 10, Eggert further teaches the pressure wave is generated within the balloon (see [0017] and [0050]).
Regarding claim 11, Eggert further teaches a third ultrasound transducer and a fourth ultrasound transducer positioned in the housing, and wherein the first ultrasound transducer and the second ultrasound transducer form a first pair of ultrasound transducers, wherein the third ultrasound transducer and the fourth ultrasound transducer form a second pair of ultrasound transducers (there are six transmitting members 26 shown in Fig. 1).
Regarding claim 12, Eggert further teaches the first pair of ultrasound transducers are configured to generate a first pressure wave within the balloon, and wherein the second pair of transducers are configured to generate a second pressure wave within the balloon, and wherein the generation of the first pressure wave occurs substantially simultaneously with generation of the second pressure wave (the transducers can be activated to produce ultrasonic waves directed towards the target region, see [0043] and [0044]).
Regarding claim 13, Eggert further teaches the first pair of ultrasound transducers are configured to generate a first cavitation event within the balloon, and wherein the second pair of transducers are configured to generate a second cavitation event within the balloon, and wherein the first cavitation event occurs substantially simultaneously with the second cavitation event (the activation of the force transmitting members causes cavitation within the balloon, see [0017] and [0050]).
Regarding claim 14, the combination of Eggert, Brisken and Rabiner teaches the ultrasound medical device of claim 1, wherein the first ultrasound transducer, the second ultrasound transducer or both the first and the second ultrasound transducers are designed to transmit an ultrasound wavelength at a first frequency, and wherein the first ultrasound transducer is longitudinally spaced away from the second ultrasound transducer between a distance of 0.5 to 3.5 times the first frequency wavelength (Brisken teaches spacing the transducers at a distance of at least 0.5 times the frequency wavelength in order to cause the transducers to constructively interfere with one another, see col. 6, lines 24-30).
Claims 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al. (US 2018/0304053) in view of Brisken et al. (US 6,296,619).
Regarding claim 15, Eggert discloses an ultrasound system (see Fig. 1-5), comprising: a generator (see [0011]); an elongate shaft (16) having a distal end region and a proximal region coupled to the generator; a balloon (18) coupled to the distal end region of the elongate shaft; and a set of ultrasound transducers coupled to the generator and positioned under the balloon (force transmitting member 26 can be ultrasound transducers, see [0016]); wherein the set of ultrasound transducers are configured to generate a first ultrasound wave and a second ultrasound wave (the transducers can be activated to produce ultrasonic waves directed towards the target region, see [0043] and [0044]).
Eggert fails to expressly teach the first ultrasound wave constructively interferes with the second ultrasound wave to generate a localized cavitation event within the balloon in order to transmit energy to a target region.
Brisken, in the same field of art, teaches a related system (see Fig. 23), including first and second ultrasound transducers (20) which are arranged to constructively interfere with one another, which enhances the effectiveness of the ultrasound delivery (see col. 6, lines 24-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Eggert by causing the first ultrasound wave to constructively interfere with the second ultrasound wave, as taught by Brisken, since doing so would have enhanced the effectiveness of the ultrasound delivery.
Regarding claim 16, Eggert further teaches the cavitation event further includes the generation of a pressure wave within the balloon (activation of the force transmitting members causes the production of ultrasonic waves within the balloon, see [0043]).
Regarding claim 17, Eggert discloses a method for treating a blood vessel (see Fig. 1-5), the method comprising: disposing a medical device within the blood vessel at a position adjacent to a lesion (medical device 10 is positioned within a blood vessel adjacent lesion 30, see Fig. 3), the medical device comprising: an elongate shaft (16) having a distal end region; a balloon (18) coupled to the distal end region; a first ultrasound transducer coupled to the shaft and positioned under the balloon; and a second ultrasound transducer coupled to the shaft and positioned under the balloon (there are a plurality of force transmitting member 26 coupled to inner member 16, which can be ultrasound transducers, see [0016]), generating a first ultrasound wave with the first ultrasound transducer; and generating a second ultrasound wave with the second ultrasound transducer (the transducers can be activated to produce ultrasonic waves directed towards the target region, see [0043] and [0044]).
Eggert fails to expressly teach the first ultrasound wave constructively interferes with the second ultrasound wave to generate a force to at least partially break apart the lesion.
Brisken, in the same field of art, teaches a related method and device (see Fig. 23), including first and second ultrasound transducers (20) which are arranged to constructively interfere with one another, which enhances the effectiveness of the ultrasound delivery (see col. 6, lines 24-30).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Eggert by causing the first ultrasound wave to constructively interfere with the second ultrasound wave, as taught by Brisken, since doing so would have enhanced the effectiveness of the ultrasound delivery.
Regarding claim 18, Eggert further teaches the balloon is designed to shift between a first unexpanded configuration (see unexpanded configuration in Fig. 3) and an expanded configuration wherein the balloon is in contact with the lesion (see expanded configuration in Fig. 4).
Regarding claim 19, Eggert further teaches the balloon is configured to be expanded by an inflation media, and wherein the generation of the force further includes the generation of a bubble within the inflation media (the balloon is necessarily inflated by some inflation media to move to the expanded configuration and the activation of the force transmitting members causes cavitation within the balloon, see [0017] and [0050]).
Regarding claim 20, Eggert further teaches the generation of the force further includes the generation of a pressure wave within the balloon (activation of the force transmitting members causes the production of ultrasonic waves within the balloon, see [0043]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related devices and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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