Obviousness

Obviousness Analysis under 35 U.S.C. § 103

A claimed invention is considered obvious under 35 U.S.C. § 103 if the differences between the claimed invention and the prior art would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention. This analysis often involves combining elements from multiple prior art references. The examiner must demonstrate a motivation to combine these references to achieve the claimed invention.

Unfortunately, the full claims of US12156669B2 were not provided in the prompt, which are essential for a detailed obviousness analysis. However, based on the provided patent summary and the disclosed prior art, a preliminary analysis can be conducted.

Disclosed Prior Art in US12156669B2:

The patent itself references U.S. Pat. No. 9,526,864, filed June 9, 2015, and titled "RETRACTION AND ASPIRATION DEVICE FOR TREATING EMBOLISM AND ASSOCIATED METHODS." This patent is incorporated by reference in its entirety within US12156669B2. This means that the teachings of US 9,526,864 are considered part of the prior art for US12156669B2.

Additionally, 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, is also incorporated by reference.

General Teachings of US 9,526,864 (Based on description in US12156669B2):

The description within US12156669B2 states that its "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." This indicates that US 9,526,864 likely describes a retraction and aspiration device, a catheter system for embolism treatment, and a tubing system for aspirating material. Key features mentioned in relation to the RA device 100 and catheter system 200 (which are similar to those in US 9,526,864) include:

• A retraction and aspiration (RA) device that is coupleable to a catheter system and operable to simultaneously retract a portion of the catheter system and aspirate through it.
• A catheter system comprising an outer guide catheter, a delivery sheath slidably received within the guide catheter, and an elongated pull (and/or push) member slidably received within the delivery sheath.
• An interventional device coupled to the push member, housed within the delivery sheath, and configured for clot removal.
• A tubing system fluidly coupled to the RA device and catheter system for directing aspirated material (blood and clot).
• A clot reservoir in the tubing system to capture clot material while allowing blood to flow through.
• One-way valves to control fluid flow and prevent backflow.
• A mechanism to generate negative pressure for aspiration.

General Teachings of US 62/554,931 (Based on description in US12156669B2):

The description in US12156669B2 explicitly states that "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." This indicates that US 62/554,931 describes a hemostasis valve that can be used as an attachment/valve member in a catheter system. Specific features mentioned include:

• A housing with a proximal and distal opening, defining a first lumen.
• A branch portion defining a second lumen branching from the first lumen.
• A compliant tubular member extending through the first lumen, defining a central lumen.
• An actuation mechanism (e.g., buttons, filaments) to collapse and seal the tubular member to maintain hemostasis around devices inserted through it.
• The ability for the tubular member to move between a collapsed/sealed state (minimum diameter) and an expanded/unsealed state (maximum diameter).
• The ability to provide a continuous lumen of generally constant diameter when open to prevent clot material from getting stuck.

Potential Obviousness Combinations (Illustrative, pending full claims):

Given the descriptions, a person having ordinary skill in the art (POSA) in intravascular medical devices would likely have been motivated to combine the teachings of US 9,526,864 and US 62/554,931.

Combination 1: US 9,526,864 + US 62/554,931

• Motivation to Combine: US 9,526,864 describes a comprehensive retraction and aspiration system for embolism treatment, including a catheter system and aspiration capabilities. However, a common challenge in such systems, particularly during multiple passes of an interventional device, is the risk of clot material being stripped and remaining in the guide catheter's proximal components, leading to reintroduction of contaminants. A POSA would be motivated to improve the hemostasis and clot retention prevention at the proximal end of the guide catheter in the system of US 9,526,864 to facilitate smoother, cleaner, and safer multiple passes of the interventional device.
• Obviousness Argument: The hemostasis valve described in US 62/554,931 specifically addresses the problems of maintaining hemostasis around varying diameter devices and providing a smooth, consistent lumen to prevent clot stripping during withdrawal. A POSA would recognize that integrating the garrote valve of US 62/554,931 as the attachment/valve member (e.g., attachment member 208, 408, or 1108) in the catheter system of US 9,526,864 would directly address the problem of preventing clot retention and reintroduction during repeated device deployment and withdrawal.
  • The attachment member 1108 in US12156669B2, directly linked to US 62/554,931, provides a "continuous lumen of generally constant diameter" when open to prevent clot material from getting stuck and minimizing the risk of reintroducing clot material. This directly maps to the problem identified in the background of US12156669B2, which US 9,526,864 alone may not fully resolve.
  • The ability to unseal and reseal the attachment member, as taught by US 62/554,931, would allow for the easy withdrawal and re-insertion of the interventional device (as described in US 9,526,864) without requiring the complete removal of the guide catheter, thereby enabling the "single insertion delivery system" claimed by US12156669B2.
  • The "large diameter" of the second lumen in the attachment members (e.g., 442, 1381), which helps inhibit clogging, is a predictable design choice for fluid aspiration systems and would be obvious to a POSA when improving an aspiration system like that in US 9,526,864.

Combination 2: US 9,526,864 + General Knowledge of Medical Device Valves/Inserts

• Motivation to Combine: Even without explicit mention of US 62/554,931, a POSA would understand the need to manage fluid flow and device passage at the proximal end of a guide catheter in a multi-pass thrombectomy system. The problems of maintaining hemostasis, preventing clot stripping, and facilitating device exchange are well-known in interventional cardiology and radiology.
• Obviousness Argument: The use of various valve inserts (like the first valve insert 650 and second valve insert 860 in US12156669B2) within an attachment member (like 408) to either create a continuous lumen or to better seal around a guidewire during aspiration would be an obvious design choice for a POSA aiming to refine the system of US 9,526,864.
  • The first valve insert 650, creating a constant diameter lumen to shield the interventional device from the main valve and prevent clot stripping (as described in US12156669B2), is a logical solution to the problem of clot retention at the attachment point, which would be apparent to a POSA familiar with existing hemostasis valve designs and their limitations.
  • Similarly, the second valve insert 860, described as a Tuohy Borst Adapter for sealing against a guidewire to improve aspiration efficiency, is a known type of medical connector that a POSA would readily incorporate into an aspiration system like that of US 9,526,864 to enhance its performance.

Conclusion (Pending Full Claims Review):

Without the full text of the claims, this analysis is limited. However, based on the provided summary and the detailed descriptions of the prior art incorporated by reference, there is a strong prima facie case for obviousness of certain aspects of US12156669B2. The core inventive concept of a "single insertion delivery system" that allows for multiple passes without full guide catheter removal appears to be achieved through the synergistic combination of a retraction/aspiration system (taught by US 9,526,864) and an improved hemostasis/access valve that minimizes clot stripping and facilitates device exchange (taught by US 62/554,931 or through general knowledge of such devices). A POSA would have been motivated to combine these known elements to address the well-understood problems of clot reintroduction and procedural efficiency in multi-pass thrombectomy procedures.