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, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on December 23rd 2025, has been entered.
Response to Amendment
The claims filed on December 23rd, 2025, have been entered. Claims 1-6, 8-11, and 13-22 remain pending in the Application. Claims 1-6, 8-11, 13-14 and 21 were previously withdrawn by the Applicant. Claims 7 and 12 have been canceled by the Applicant.
Response to Arguments
The 103 rejection of claims 15-20 and 22 over Rule et al. (Pub. No. 2005/0197619) in view of Syed et al. (Pub. No. 2019/0298182) and Dixon et al. (Pub. No. 2015/0272601) has been withdrawn in light of Applicant’s amendment made December 23rd, 2025; specifically, none of the cited references teaches automatically activating in accordance with logic of the medical system the one or more ultrasound transducers upon identification of the intraluminal clot to decompose the intraluminal clot with ultrasound.
Applicant’s arguments with respect to claim(s) 15-20 and 22 have been 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. It is noted that Applicant argues that the newly added claim limitations are not taught by the cited references; however, as discussed below, the newly added reference Davies et al. (Pub. No. 2024/0350193) teaches said limitation.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (Pub. No. 2021/0128869) in view of Rule et al. (Pub. No. 2005/0197619) and Davies (Pub. No. 2024/0350193).
Regarding claim 15, Davis et al. discloses a method of ultrasonic decomposition of intraluminal clots ([0044]; FIGs. 5C-6), comprising: inserting a stylet (112) into a lumen (22) of a catheter (5) including a fluid ([0034] 112 is inserted into 22, and introduces fluid into 5, which may already have fluid from being inserted into the vasculature of the patient as described in [0032]), the stylet including: one or more ultrasound transducers (180; FIG. 6); and a plurality of electrical impedance sensors (192, 194) disposed along a distal portion of the stylet (FIG. 5C: 192 and 194 are positioned along the distal portion of 112), wherein the plurality of electrical impedance sensors and the one or more ultrasound transducers are coupled with a medical system (100; [0045] 192 and 194 send signals to 100, and [0047] 100 directs 180 to introduce ultrasound to the clot); identifying an intraluminal clot in the catheter by detecting changes in impedance between two or more of the electrical impedance sensors ([0045] 192 and 194 send information to a processor to determine if a change in impedance indicates a partial occlusion of 22 by occlusion 50); activating in accordance with logic of the medical system the one or more ultrasound transducers upon identification of the intraluminal clot to decompose the intraluminal clot with ultrasound ([0052] after 50 has been identified, ultrasound energy is sent to break up 50).
Davis et al. does not disclose the ultrasound transducer is positioned at a distal end of the stylet, and that the plurality of electrical impedance sensors are disposed proximal to the one or more ultrasound transducers.
Rule et al. teaches in the same field of endeavor of ultrasound devices for clot removal (Abstract), and discloses ultrasound transducers (165; FIG. 4; [0033] 165 may comprise multiple ultrasound members) positioned at a distal end of a stylet (100).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the ultrasound transducer of Davis et al. (external system) for the ultrasound transducers of Rule et al. (distal tip array) because both transducers are equivalent structures for delivering ultrasonic energy from the distal tip of the stylet, and the substitution of one for the other would have the predictable result of allowing for clot removal through the delivery of ultrasound energy. This substitution would place the ultrasound transducers at the distal tip of 112, which would make the plurality of electrical impedance sensors 192 and 194 proximal to the ultrasound transducers.
Davis et al. as modified by Rule et al. does not disclose the activation of the ultrasound transducers is automatic.
Davies discloses an electrical system (400; FIG. 4; [0062]) which receives a signal ([0062] ECG signal from ECG electrodes), measures the signal ([0062] ECG measurement device 402), and delivers energy automatically in response to the signal ([0062] perforation is automatically done by energy source 406 in response to the ECG signal reaching certain levels) for the purpose of obviating the need for user intervention ([0062]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the ultrasound system of Davis et al. to be automatically activating in response to clot detection, in view of Davies, for the purpose of obviating the need for user intervention.
Regarding claim 16, Davis et al. as modified by Rule et al. and Davies further discloses decomposing the intraluminal clot further includes decomposing the intraluminal clot by ultrasonic cavitation of the fluid proximate of the intraluminal clot (Davis et al. [0050] the ultrasound energy is introduced to pressurized fluid passing through 122 to cause the occlusion 50 to be broken up).
Regarding claim 17, Davis et al. as modified by Rule et al. and Davies further discloses decomposing the intraluminal clot further includes decomposing the intraluminal clot by ultrasonic agitation of a thrombolytic drug in the fluid proximate the intraluminal clot (Davis et al. [0034] a plasminogen activator (tPA) can be introduced in the pressurized fluid to aid in the dissolution of 50).
Regarding claim 18, Davis et al. as modified by Rule et al. and Davies further discloses injecting the thrombolytic drug into the lumen of the catheter before ultrasonic agitation of the thrombolytic drug in the fluid proximate the intraluminal clot (Davis et al. [0034] the fluid being injected into 22, which includes tPA, is done prior to the ultrasound being activated).
Regarding claim 19, Davis et al. as modified by Rule et al. and Davies further discloses decomposing the intraluminal clot further includes decomposing the intraluminal clot with the stylet while one-or-more ultrasound transducers are in operation ([0048] 180 is active in sending out ultrasound energy to break the clot).
Regarding claim 20, Davis et al. as modified by Rule et al. and Davies further discloses decomposing the intraluminal clot with ultrasound includes using ultrasound provided by the one-or-more ultrasound transducers formed into an array of ultrasound transducers embedded in the distal portion of the stylet (Rule et al. [0033] 165 can comprise multiple ultrasound radiating members, which would form an array at the distal end of the stylet).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. in view of Rule et al. and Davies, and in further view of Syed et al. (Pub. No. 2019/0298182).
Regarding claim 22, Davis et al. as modified by Rule et al. and Davies discloses the invention as claimed in claim 15, as discussed above. The modified invention does not disclose the one or more electrical impedance sensors include at least two ring electrodes separated longitudinally along the stylet.
Syed et al. discloses a stylet (12) with one or more electrical impedance sensors (20a-20d), where the electrical impedance sensors are ring electrodes separated longitudinally along the stylet ([0031] 20a-20b can be complete ring electrodes, which are spaced longitudinally; FIG. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date to have substituted the electrical impedance sensors of Davis et al. (flat; FIG. 5C) for the electrical impedance sensors of Syed et al. (rings) because both sensors are equivalent structures for determining impedance, and the substitution of one for the other would have the predictable result of detecting changes in the levels of impedance.
Conclusion
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/JRM/Examiner, Art Unit 3771
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771