Obviousness

Obviousness Analysis of US Patent 12016580 Under 35 U.S.C. § 103

This analysis identifies combinations of prior art references that would render the claims of US Patent 12016580 obvious to a person having ordinary skill in the art (POSA) at the time of the invention. The core innovation of US12016580 is enabling multiple passes of an interventional device for clot removal without fully withdrawing the guide catheter, by employing an attachment member that can be unsealed to prevent clot stripping and by aspirating the guide catheter between passes.

Identified Prior Art References:

1. US Patent No. 9,526,864 ("the '864 patent"): Titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS," this patent is explicitly incorporated by reference into US12016580. US12016580 states that its retraction and aspiration (RA) device 100, catheter system 200, and tubing system 300 "can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864". [cite: The RA device 100, the catheter system 200, and the tubing system 300 can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled “RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.] This reference teaches the fundamental aspects of a system and method for simultaneously retracting an interventional device and aspirating through a guide catheter to remove emboli.
2. U.S. Provisional Patent Application No. 62/554,931 ("the '931 provisional"): Titled "HEMOSTASIS VALVES AND METHODS OF USE," this provisional application is also incorporated by reference into US12016580. US12016580 specifically identifies its attachment member 1108 as being, for example, a "garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931". [cite: The attachment member 1108 can be, for example, a garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled “HEMOSTASIS VALVES AND METHODS OF USE,” which is reproduced in Appendix D to this application, and which is incorporated herein by reference in its entirety.] This reference therefore teaches an actuatable hemostasis valve designed to address fluid flow and device passage.

Both the '864 patent (filed June 9, 2015) and the '931 provisional (filed September 6, 2017) predate the priority date of US12016580 (January 26, 2018), making them valid prior art.

Problem Addressed by US12016580:

US12016580 explicitly identifies a problem in existing thrombectomy systems: the difficulty or impossibility of making repeated attempts (multiple "passes") to remove clot material. If a first pass is incomplete, conventional systems require the entire catheter system, including the guide catheter, to be fully removed from the patient, cleaned, and then reinserted for a second pass. This process is time-consuming, traumatic for the patient, and carries a significant risk of stripping clot material from the interventional device as it is withdrawn through the hemostasis valve, potentially reintroducing it into the patient. [cite: Moreover, with many devices, it is difficult or not possible to make repeated attempts at removing clot material (e.g., to make multiple passes with a device). In particular, if a first pass with a device does not completely capture and/or collect all of the clot material, the device and an accompanying catheter system must be removed from the patient, cleaned, and subsequently reinserted into the patient in order to make a second pass and remove additional material. This can be time consuming and traumatic for the patient. Thus, there exists a need for an improved embolic extraction device.] The patent specifically notes that a conventional valve in the attachment member "may strip (e.g., break off, shear, etc.) clot material PE that held by the interventional device ID," leading to clot remaining in the attachment member and the risk of reintroduction. [cite: The valve 445 may strip (e.g., break off, shear, etc.) clot material PE that held by the interventional device ID. This can cause clot material PE to remain in the attachment member 408 after the interventional device ID is fully withdrawn from the patient, which presents a significant risk that remaining clot material PE will be reintroduced into the blood vessel BV of the patient if a second pass is made with the interventional device ID without fully removing the guide catheter 206 from the patient to enable cleaning of the guide catheter 206 and the attachment member 408.]

Obviousness Combination and Motivation:

A person of ordinary skill in the art (POSA) in the field of intravascular clot retrieval would be well aware of the limitations described in the background of US12016580 regarding multi-pass procedures and the issue of clot stripping at the hemostasis valve.

Combination of US 9,526,864 and US 62/554,931 (or similar known actuatable hemostasis valves):

• US 9,526,864 provides the core technology of a retraction and aspiration system (RA device, catheter system, tubing system) capable of simultaneously retracting an interventional device and aspirating through a guide catheter to remove clot material from a blood vessel. [cite: The RA device 100, the catheter system 200, and the tubing system 300 can be the same as or similar to one or more of the retraction and aspiration devices, catheter systems, and tubing systems disclosed in U.S. Pat. No. 9,526,864, filed Jun. 9, 2015, and titled “RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS,” which is incorporated herein by reference in its entirety.] This reference provides the fundamental means for engaging, retracting, and aspirating clot material.
• US 62/554,931 (the garrote valve described therein, which is US12016580's attachment member 1108) teaches an actuatable hemostasis valve designed to be moved between a sealed configuration and an unsealed (open/expanded) configuration. Crucially, in its unsealed configuration, this valve can create a "continuous lumen of generally constant diameter" when a device is passed through it. [cite: The attachment member 1108 can be, for example, a garrote valve (e.g., a hemostasis valve) as disclosed in provisional U.S. Patent Application No. 62/554,931, filed Sep. 6, 2017, and titled “HEMOSTASIS VALVES AND METHODS OF USE,” which is reproduced in Appendix D to this application, and which is incorporated herein by reference in its entirety.] [cite: The actuation mechanism 1375 can be a manual actuator such as one or more buttons 1378. Depression or release of the buttons can, in some embodiments, facilitate sealing of the tubular member 1372 around tools or instruments of a wide range of sizes and/or diameters that fit through the tubular member 1372.] [cite: The central lumen 1374 of the tubular member 1372 and the first lumen 1371 of the housing 1370 can together provide a continuous lumen of generally constant diameter.] US12016580 explicitly states that this "constant diameter can prevent clot material PE associated with the interventional device ID from getting stuck in (e.g., remaining in) the attachment member 1108 as the interventional device ID is retracted through the attachment member 1108 —thus minimizing the risk of reintroducing clot material to the patient upon a second pass using the interventional device ID (or another interventional device)." [cite: Such a constant diameter can prevent clot material PE associated with the interventional device ID from getting stuck in (e.g., remaining in) the attachment member 1108 as the interventional device ID is retracted through the attachment member 1108 —thus minimizing the risk of reintroducing clot material to the patient upon a second pass using the interventional device ID (or another interventional device).]

Motivation for Combination:

A POSA, recognizing the problem of clot stripping and the inefficiencies of fully removing and reinserting the guide catheter for multiple passes in the system taught by the '864 patent, would be highly motivated to incorporate a hemostasis valve that mitigates these issues. The '931 provisional explicitly describes a garrote valve designed for such purposes, particularly its ability to create a continuous, constant-diameter lumen to facilitate device passage and prevent material retention.

Combining the effective clot removal and aspiration system of the '864 patent with the specialized hemostasis valve of the '931 provisional would be an obvious design choice for a POSA seeking to improve multi-pass thrombectomy procedures. The resulting system would allow for:

• Unsealing the attachment member: By actuating the garrote valve (or using an insert like the first valve insert 650 described in US12016580), the lumen through the attachment member could be expanded to match the guide catheter's lumen, allowing the clot-laden interventional device to pass without stripping clot material. This directly solves the problem identified by US12016580. [cite: The first valve insert 650 helps create a lumen of constant diameter through the attachment member 408 such that a diameter of the interventional device ID does not substantially change (e.g., expand and/or contract) as the interventional device ID is withdrawn proximally through the attachment member 408.] [cite: The first valve insert 650 of the present technology inhibits clot material PE engaged with the interventional device ID from being stripped by the valve 445 within the attachment member 408 and, therefore, enables a second pass with the interventional device ID to be made without removing the guide catheter 206 from the patient.]
• Resealing the attachment member: After withdrawal, the actuatable valve could be resealed to maintain hemostasis for subsequent steps. This is an inherent function of such a valve.
• Aspirating the guide catheter: The aspiration capability already taught by the '864 patent would then be employed to clear any residual blood or small clot fragments from the guide catheter before the next pass, further reducing contamination risk. [cite: Aspirating the guide catheter 206 removes any residual clot material PE remaining in the guide catheter 206.]

The combination directly addresses the stated "need for an improved embolic extraction device" that allows for "repeated attempts at removing clot material" without the need to "fully remov[e] the guide catheter 206 from the patient." [cite: Moreover, with many devices, it is difficult or not possible to make repeated attempts at removing clot material (e.g., to make multiple passes with a device). In particular, if a first pass with a device does not completely capture and/or collect all of the clot material, the device and an accompanying catheter system must be removed from the patient, cleaned, and subsequently reinserted into the patient in order to make a second pass and remove additional material. This can be time consuming and traumatic for the patient. Thus, there exists a need for an improved embolic extraction device.] [cite: The first valve insert 650 of the present technology inhibits clot material PE engaged with the interventional device ID from being stripped by the valve 445 within the attachment member 408 and, therefore, enables a second pass with the interventional device ID to be made without removing the guide catheter 206 from the patient.]

Therefore, the methods and system claimed in US12016580, specifically the features enabling multiple passes through an actuatable attachment member that prevents clot stripping, followed by resealing and aspiration, would be obvious to a POSA when combining the teachings of US 9,526,864 and US 62/554,931.