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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after appeal to the Patent Trial and Appeal Board, but prior to a decision on the appeal. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 08/24/2026 has been entered.
Claims 1-3 and 7-13 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 Claims 1-20 are currently pending in the application with claims 5 and 14-20 being withdrawn from further consideration.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. 6-9, filed 08/24/2026, with respect to the rejections of the claims under 35 U.S.C.103 have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Tran et al. (US 2019/0282249).
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. Eggert is also silent about whether the emitted ultrasound field is unfocused.
Eggert discloses a prior art method of breaking down an intravascular lesion upon which the claimed invention (ultrasound transducers driven at one or more frequencies in a range of 20 kilohertz to 50 megahertz and emitting an unfocused ultrasound field) can be seen as an “improvement” (Eggert is silent about frequency range of the ultrasonic transducers and whether the emitted ultrasound field is unfocused).
Tran, in the same field of art, teaches a related method for breaking down an intravascular lesion (see [0018]) comprising advancing a similarly constructed catheter (see catheter 10 in Fig. 1; catheter 10 can include an expandable member similarly as shown in Fig. 5, see [0047]) having one or more transducers (14, see [0046]) which emit an unfocused ultrasound field and are driven at a frequency within the range of 20 kHz to 50 MHz (see [0045] and [0046]).
Thus, the manner of enhancing a particular method for breaking down an intravascular lesion was made part of the ordinary capabilities of one skilled in the art based upon the teachings of Tran.
Accordingly, 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 ultrasound transducers to emit an unfocused ultrasound field and be driven at a frequency in the range of 20 kHz to 50 MHz, as taught by Tran, since one of ordinary skill would have been capable of applying this known “improvement” technique in the same manner to the prior method of Eggert and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have recognized that applying energy in the way taught by Tran in the method of Eggert would have been effective for fracturing vascular lesions. KSR, 550 U.S. at 401.
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 Tran, as applied to claim 1 above, and further in view of Brisken et al. (US 6,296,619 B1).
Regarding claim 8, the combination of Eggert and Tran 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.
Brisken, in the same field of art, teaches an ultrasonic transducer (20, see Fig. 1A) that emits energy in both a radial direction and a direction parallel to a longitudinal axis of the catheter shaft (see col. 9, lines 40-46) for a more uniform dosage of ultrasonic energy (see col. 2, lines 23-35).
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 Tran so that the ultrasound field is emitted in both a parallel and radial direction, as taught by Brisken, since doing so would have allowed for more uniform application of ultrasound energy.
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert in view of Tran, and further 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 expressly teach ultrasound transducers are driven at one or more frequencies in a range of 20 kilohertz to 50 megahertz and is silent about whether the emitted ultrasound field is unfocused. Eggert also fails to teach the catheter further comprising a stent.
Eggert discloses a prior art method of breaking down an intravascular lesion upon which the claimed invention (ultrasound transducers driven at one or more frequencies in a range of 20 kilohertz to 50 megahertz and emitting an unfocused ultrasound field) can be seen as an “improvement” (Eggert is silent about frequency range of the ultrasonic transducers and whether the emitted ultrasound field is unfocused).
Tran, in the same field of art, teaches a related method for breaking down an intravascular lesion (see [0018]) comprising advancing a similarly constructed catheter (see catheter 10 in Fig. 1; catheter 10 can include an expandable member similarly as shown in Fig. 5, see [0047]) having one or more transducers (14, see [0046]) which emit an unfocused ultrasound field and are driven at a frequency within the range of 20 kHz to 50 MHz (see [0045] and [0046]).
Thus, the manner of enhancing a particular method for breaking down an intravascular lesion was made part of the ordinary capabilities of one skilled in the art based upon the teachings of Tran.
Accordingly, 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 ultrasound transducers to emit an unfocused ultrasound field and be driven at a frequency in the range of 20 kHz to 50 MHz, as taught by Tran, since one of ordinary skill would have been capable of applying this known “improvement” technique in the same manner to the prior method of Tran and the results would have been predictable to one of ordinary skill in the art, namely, one skilled in the art would have recognized that applying energy in the way taught by Tran in the method of Eggert would have been effective for fracturing vascular lesions. KSR, 550 U.S. at 401.
The combination of Eggert and Tran 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 Eggert 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, Tran, and Dong, as applied to claim 9 above, and further in view of Brisken.
Regarding claim 13, the combination of Eggert, Tran, 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.
Brisken, in the same field of art, teaches an ultrasonic transducer (20, see Fig. 1A) that emits energy in both a radial direction and a direction parallel to a longitudinal axis of the catheter shaft (see col. 9, lines 40-46) for a more uniform dosage of ultrasonic energy (see col. 2, lines 23-35).
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 Tran so that the ultrasound field is emitted in both a parallel and radial direction, as taught by Brisken, since doing so would have allowed for more uniform application of ultrasound energy.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tran et al. (US 20190282250 A1) and Geva et al. (US 20180104455 A1) teach related catheters and methods for breaking down a lesion.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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