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 § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Naglreiter et al. US Patent Application Publication 2022/0168000.
As to claim 1, Naglreiter teaches a thrombus removal system, for use in performing thrombectomy procedures (Abstract)comprising:
an elongate catheter 20 having proximal 52 and distal 50 ends, a length (Fig. 1) and an inner diameter 90 (Fig. 1; Para. 0039-0040);
an aspiration pump 30 having a housing 110, 412, 414 (Fig. 1, 7, 8), a user interface 126, 130, 132, 134, and 136, 406 – where Naglreiter teaches the controller may be programmed to provide visual and audible feedback to the user (para. 0043, 0063), a microprocessor controller 418 (para. 0043, 0063-0064), a pump assembly 114, 416 having a rotor assembly including a motor 444 (para. 0044, 0064), an aspiration container 112,404 (Fig. 1 and 8), a pump sensor 116, 428 and a data storage module 118, 418 (para. 0005-0006, 0010; 0043, 0063, 0064-0066);
a flexible pump extension tube 70, 408 having first and second ends and a length extending there between (Fig. 1, 8, 9; para. 0007, 0064), the extension tube first end being connected to the aspiration pump and the second end being connected to a coupler, wherein the coupler is coupled to the proximal end of the catheter (Fig. 1; para. 0044, 0062).
a safety circuit coupled to the aspiration pump, the aspiration pump having an operable mode that generates a cyclic pressure waveform such that when the aspiration pump is coupled to the catheter positioned within a vessel adjacent a thrombus and operated, the pump controllably cycles supplying negative and positive pressure to the catheter to aspirate the thrombus through the catheter to the pump aspiration container - where Naglreiter teaches alternative sensors and or multiple pressure sensors (not shown) can be utilized on connector tubing 408 to provide feedback information verifying accurate readings and or providing a safety back up are also suitable (para. 0043-0044, 0065). Thus, the examiner interprets the ‘safety circuit’ as components such as controllers and sensors that prevent misoperation of the system.
As to claim 2, the safety circuit has a first configuration that allows normal pump operation and a second configuration that alters pump operation when the pump sensor is above or below a predetermined limit - where Naglreiter teaches when the pump is connected to the aspiration catheter, and initially placed in the ‘on’ position, and if the in-line pressure sensor indicates that fluid in the line is ‘free flowing’, the pump will provide a steady full vacuum pressure ramp up until the pressure sensor indicates fluid in the line is ‘restricted’. Otherwise, the pump will shut off after 30 seconds to mitigate blood loss (para. 0046, 0078).
As to claim 3, the safety circuit monitors the rotational position and direction of the motor such that when the motor rotation exceeds a predetermined rotational position and direction, the safety circuit alters rotational movement of the motor- where Naglreiter teaches a motor with an encoder for controlling rotation, speed, and position (para. 0064). Naglreiter further teaches the controller board sends signals to the motor 444 to operate speed, position, and direction (in conjunction with the connected rotor) to provide a positive pressure cyclic waveform with the motor operating in a second opposite rotational direction (Fig. 11 and 12; para. 0067-0068).
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As to claim 4, the safety circuit monitors the rotational position and direction of the motor such that when the motor rotation is below a predetermined rotational position and direction, the safety circuit alters rotational movement of the motor – where Naglreiter teaches a motor with an encoder for controlling rotation, speed, and position (para. 0064). Naglreiter further teaches the controller board sends signals to the motor 444 to operate speed, position, and direction (in conjunction with the connected rotor) to provide a positive pressure cyclic waveform with the motor operating in a second opposite rotational direction (Fig. 11 and 12; para. 0067-0068).
As to claim 5, a thrombus removal system as in claim 2, wherein the pump sensor takes the form of a pressure sensor – where Naglreiter teaches the pump can measure the pressure of the fluid in the line immediately distal to the pump outlet but proximal to the pump extension tubing (para. 0044-0045, 0049).
As to claim 6, a thrombus removal system as in claim 2 wherein the pump sensor takes the form of a flow meter – where Naglreiter teaches once the pump pressure sensor indicates the fluid in the line is ‘restricted’, the embedded software will instruct the pump to run thru a series of cyclic pressure varying waveforms…During each variation, the embedded software will utilize sensors to sense, simultaneously, fluid in the line and the state of fluid movement. If the sensor detects the fluid in the line is ‘moving’, the pump will maintain the current cyclic pressure waveform until the sensor detects the fluid in the line is in a ‘free flowing’ state (para. 0047, 0049).
As to claim 7, the extension tubing 408 includes a pressure relief valve that is activated by the safety circuit - where Naglreiter teaches the aspiration pump can provide fast positive pressures waveforms above blood pressure (to an attached and paired catheter restricted with thrombus) in conjunction with the in-line sensor 428 to dislodge the thrombus but prevent expelling the thrombus from the catheter. As a safety measure, the connector tubing 408 connecting the pump to the catheter may include an inline pressure release valve which can activate to release pressure prior to entering the catheter (para. 0077).
As to claim 8, the safety circuit incudes a mechanical rotor limiter that prevents positive fluid flow supplied to the catheter from the aspiration pump from exceeding a predetermined limit – where Naglreiter teaches when paired with an appropriate catheter the pump can alternate between supplying negative pressure (Fig. 11) and a fast positive pressure waveform (Fig. 12) to the catheter. Naglreiter teaches the operation of the pump utilizing the configurations (rotor rotation directions supplying negative pressure Fig. 11 and positive pressure Fig. 12) are controlled by the controller board which sends signals to the motor 444 to operate speed, position, and direction. Naglreiter further teaches the use of inline sensors coupled to the pump can be utilized by the controller board to aid in verification that a particular algorithm or program is being effective at producing a desired pressure waveform (para. 0068).
As to claim 9, a thrombus removal system 10 as in claim 3, wherein the motor is a stepper motor (para. 0044, 0064).
As to claim 10, a thrombus removal system 10 as in claim 4, wherein the motor is a stepper motor (para. 0044, 0064).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Daniel et al. USPN 10772644, Naglreiter et al. US Patent Application Publication 20220168002, and Culbert et al. US Patent Application Publication 20190381223 are cited to show systems and methods for removal of thrombotic material.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JACQUELINE F STEPHENS whose telephone number is (571)272-4937. The examiner can normally be reached 8:30-5:00.
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/JACQUELINE F STEPHENS/ Primary Examiner, Art Unit 3781