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 .
Response to Amendment
This Office action is responsive to the amendment filed 12/03/2025. Claims 1 and 9 have been amended. Claims 1-20 are currently pending in the application with claims 5 and 14-20 being withdrawn from further consideration.
Response to Arguments
Applicant’s arguments, see pg. 5-6, filed 12/03/2025, with respect to the rejections of the claims under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Gustus et al. (US 2010/0076299) and Dong et al. (US 2018/0228537).
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.
Claims 1-4, 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al. (US 2018/0304053) in view of Gustus et al. (US 2010/0076299).
Regarding claims 1 and 4, Eggert discloses a method for breaking down an intravascular lesion (see Fig. 1-4), the method comprising: advancing a catheter (10) through a vasculature system to a target location (see Fig. 3-4 and [0047]), the catheter comprising: a catheter shaft (12) comprising an outer tubular member (14) and an inner tubular member (16); an inflatable balloon (18) secured to a distal portion of the catheter shaft (see Fig. 1); and one or more ultrasound transducers (force transferring members 26 can be ultrasound transducers, see [0016]); and activating the one or more ultrasound transducers to emit an ultrasound field, the ultrasound field directed towards the target location (see Fig. 4 and [0044]).
Eggert fails to expressly teach ultrasound transducers are driven at one or more frequencies in a range of 20 kilohertz to 50 megahertz.
Gustus, in the same field of art, teaches a related method for breaking down an intravascular lesion (see [0070] and Fig. 4) using ultrasound transducers driven at a frequency within the range of 150 kHz to 5 MHz (see [0092]), which is within the claimed range.
Gustus discloses the frequency is a result effective variable in that changing the frequency of changes the effectiveness of the treatment on target tissue at different depths (see Gustus [0092]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Eggert by causing the ultrasound transducers to be driven at a frequency in the range of 150 kHz to 5 MHz, as taught by Gustus, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 2, Eggert further discloses wherein at least one of the one or more ultrasound transducers are coupled to the inflatable balloon (force transferring members 26 are coupled to balloon 18 via inner member 16, see Fig. 1).
Regarding claim 3, Eggert further discloses wherein at least one of the one or more ultrasound transducers are coupled to the inner tubular member (force transferring members 26 are coupled to inner member 16, see Fig. 1).
Regarding claim 6, Eggert further discloses wherein the one or more ultrasound transducers are arranged in one or more arrays (see Fig. 1).
Regarding claim 7, Eggert further discloses wherein the ultrasound field is emitted radially from the catheter (see Fig. 4).
Claims 8 is rejected under 35 U.S.C. 103 as being unpatentable over Eggert and Gustus, as applied to claim 1 above, and further in view of Hingston et al. (US 2016/0287223).
Regarding claim 8, the combination of Eggert and Gustus teaches the method of claim 1, but fails to teach wherein the ultrasound field is emitted in a direction parallel to a longitudinal axis of the catheter shaft.
Hingston, in the same field of art, an ultrasound transducer (108, see Fig. 3) at the distal end of a catheter for allowing a user to properly orient the device, navigate to and image a target location (see [0140]). The ultrasound transducer emits an ultrasound field in a direction parallel to a longitudinal axis of the catheter shaft (see Fig. 4C).
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 and Gustus so that an ultrasound transducer is coupled to a distal end of the inner tubular member and an ultrasound field is emitted in a direction parallel to the longitudinal axis of the catheter shaft, as taught by Hingston, since doing so would allow a user to properly orient the device, navigate to and image a target location.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al. (US 2018/0304053) in view of Dong et al. (US 2018/0228537).
Regarding claim 9, Eggert discloses a method for breaking down an intravascular lesion (see Fig. 1-4), the method comprising: advancing a catheter (10) through a vasculature system to a target location (see Fig. 3-4 and [0047]), the catheter comprising: a catheter shaft (12) comprising an outer tubular member (14) and an inner tubular member (16); an inflatable balloon (18) secured to a distal portion of the catheter shaft (see Fig. 1); and one or more ultrasound transducers (force transferring members 26 can be ultrasound transducers, see [0016]); and activating the one or more ultrasound transducers to emit an ultrasound field, the ultrasound field directed towards the target location (see Fig. 4 and [0044]).
Eggert fails to teach the catheter further comprising a stent.
Dong, in the same field of art, teaches a related method for treating a blood vessel using a balloon catheter comprising a stent (see abstract and Fig. 1) for ensuring the vessel remains open after the vessel is treated (see [0006]).
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 Egger so that the catheter additionally included a stent, as taught by Dong, since doing so would allow for stent placement within the same procedure thereby ensuring the vessel remains open after treatment.
Regarding claim 10, Eggert further discloses wherein at least one of the one or more ultrasound transducers are coupled to the inflatable balloon (force transferring members 26 are coupled to balloon 18 via inner member 16, see Fig. 1).
Regarding claim 11, Eggert further discloses wherein at least one of the one or more ultrasound transducers are coupled to the inner tubular member (force transferring members 26 are coupled to inner member 16, see Fig. 1).
Regarding claim12, Eggert further discloses wherein the ultrasound field is emitted radially from the catheter (see Fig. 4).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Eggert and Dong, as applied to claim 9 above, and further in view of Hingston et al. (US 2016/0287223).
Regarding claim 13, the combination of Eggert and Dong teaches the method of claim 9, but fails to teach wherein the ultrasound field is emitted in a direction parallel to a longitudinal axis of the catheter shaft.
Hingston, in the same field of art, an ultrasound transducer (108, see Fig. 3) at the distal end of a catheter for allowing a user to properly orient the device, navigate to and image a target location (see [0140]). The ultrasound transducer emits an ultrasound field in a direction parallel to a longitudinal axis of the catheter shaft (see Fig. 4C).
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 and Dong so that an ultrasound transducer is coupled to a distal end of the inner tubular member and an ultrasound field is emitted in a direction parallel to the longitudinal axis of the catheter shaft, as taught by Hingston, since doing so would allow a user to properly orient the device, navigate to and image a target location.
Conclusion
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.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771