DETAILED ACTION
Notice of 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 Arguments
Applicant's arguments filed 09/03/2026 have been fully considered but they are moot in view of the new grounds of rejection.
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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) 1-3, 6-12, 15, 16, 19, 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brouillette (US 20200383692).
Regarding claims 1, 9, 10, 12, 15, 19, 21, Brouillette discloses a system and method, comprising: an ultrasound transducer ([0001]: “using mechanical waves, such as ultrasound”, [0002], Fig. 2: “mechanical wave source”); a catheter for insertion into a body lumen of a patient, the catheter including a distal end ([0072]); a reflective surface connected to the catheter near the distal end, the reflective surface formed from a material having an acoustic impedance mismatch with an adjacent material ([0075]: “acoustic impedance being greater than that of surroundings”; [0084]: “reflective external surface” of the attached inflatable balloon); and an inflatable element connected to the distal end of the catheter, wherein the reflective surface is positioned outside of an internal volume of the inflatable element, and wherein the inflatable element is inflatable within said body lumen (Figs. 1 and 2; [0084]: “a reflective external surface, such as an inflatable balloon”). Brouillette discloses that the acoustic energy source is positioned such that the target is between the acoustic energy source and the reflective surface (Figs. 1 and 2). Brouillette does not explicitly disclose that the inflatable element is used to move the reflective surface toward a target location within said body lumen. However, Brouillette does teach an inflatable balloon with a reflective external surface and when such a balloon is inflated against internal structures, the balloon would naturally move towards those structures. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the balloon to brace a reflective surface against a target as taught by Brouillette, as to provide a reflective surface near a target structure. Brouillette does not explicitly disclose targeting a “plaque deposit”, however Brouillette does teach a system where the mechanical waves introduced into the body are for the purpose of breaking up a target ([0068]: “cracks…ablate…cleaves or breaks”). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the mechanical waves to a plaque deposit, as to provide a therapeutic effect against plaque.
Regarding claim 2, Brouillette discloses that the ultrasound transducer is separate from the catheter (Fig. 2).
Regarding claim 3, Brouillette discloses that the ultrasound transducer is configured to be operated outside of said body lumen (Fig. 2).
Regarding claims 6, 11, 16, Brouillette discloses that the reflective surface is an outside surface of the inflatable element [0084]: “reflective external surface” of the attached inflatable balloon).
Regarding claim 7, Brouillette does not explicitly disclose a reflector connected to the distal end of the catheter, wherein the reflector is a different component from the inflatable element and wherein the reflector includes the reflective surface. However, Brouillette teaches that a reflective material may be a coating ([0032]). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply a separate component in the form of a coating, as to provide a separation of elements in a system.
Regarding claim 8, Brouillette does not explicitly disclose that the reflective surface is formed from a steel alloy. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply a steel allow because steel is a well-known acoustically reflective surface.
Claim(s) 4, 5, 13, 14, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brouillette (US 2020/0383692), as applied to claims 1, 10, 15 above, in view of Zhou (US 20060241572, of record).
Regarding claim 4, Brouillette does not explicitly disclose an optical energy source connected to the catheter, an emission end of the optical energy source located at the distal end of the catheter. However, Zhou teaches an optical energy source located at the distal end of a catheter (Fig. 4A, [0051]: “fiber 41” transmits laser light for ablation). Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the laser of Zhou to the catheter of Brouillette, as to provide additional means of breaking down plaque deposits.
Regarding claim 5, Brouillette does not explicitly disclose that the emission end is at least partially embedded in a reflector which includes the reflective surface. However, Zhou teaches an optical energy source located at the distal end of a catheter (Fig. 4A, [0051]: “fiber 41” transmits laser light for ablation). The structure of Zhou’s distal end and the reflective material of Emery would be readily combined since the material covers the entirety of the distal end. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the laser of Zhou to the catheter of Brouillette, as to provide additional means of breaking down plaque deposits.
Regarding claims 13, 14, and 18, Brouillette does not explicitly disclose providing a sequence of laser pulses through an optical conduit to said plaque, simultaneous with the transmitting of ultrasound energy. However, Zhou teaches an optical energy source located at the distal end of a catheter (Fig. 4A, [0051]: “fiber 41” transmits laser light for ablation). Since the ultrasound and laser devices are separate devices, it would have been obvious that they may both be operated at the same time, to enhance the breakdown of the target structure. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the present invention to apply the laser of Zhou to the catheter of Brouillette, as to provide additional means of breaking down plaque deposits.
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 extension fee 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 date of this final action.
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/JASON M IP/Primary Examiner, Art Unit 3793
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