Patent Application 17885790 - SYSTEMS AND METHODS FOR REMOVAL OF BLOOD AND

Title: SYSTEMS AND METHODS FOR REMOVAL OF BLOOD AND THROMBOTIC MATERIAL
Application Information

Invention Title: SYSTEMS AND METHODS FOR REMOVAL OF BLOOD AND THROMBOTIC MATERIAL
Application Number: 17885790
Submission Date: 2025-05-15T00:00:00.000Z
Effective Filing Date: 2022-08-11T00:00:00.000Z
Filing Date: 2022-08-11T00:00:00.000Z
National Class: 604
National Sub-Class: 533000
Examiner Employee Number: 90608
Art Unit: 3783
Tech Center: 3700
Rejection Summary

102 Rejections: 0
103 Rejections: 1
Cited Patents

The following patents were cited in the rejection:
US 0165574🔗
US 0282821🔗
Office Action Text


    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 § 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.

Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Look et al. (USPGPub 2015/0282821) in view of Ressemann et al. (USPGPub 2002/0165574). 

Re Claim 1, Look teaches a method for aspirating thrombus in a subject (Look Fig. 31; ¶ 0116-0117), comprising: providing an aspiration catheter (4) comprising a supply lumen (370), an aspiration lumen (330) (Look Figs. 32 and 43), and a first connector (22) hydraulically coupled to the proximal end of the aspiration lumen (330) (Look Fig. 43; ¶ 0126); providing a pressure sensor (12) having an internal passageway (42) and comprising a distal connector (46) configured to hydraulically couple to the first connector (22) (Look Fig. 44C; ¶ 0127-0128), a proximal connector (38) configured to couple to a vacuum source (6) (Look ¶ 0126-0127), and a valve (8) disposed between the distal connector (46) and the proximal connector (38) of the pressure sensor (12), the valve (8) having an open state and a closed state (Look Fig. 43; ¶ 0126-0127); coupling the pressure sensor (12) to the aspiration catheter (4) and the vacuum source (6) (Look Fig. 43; ¶ 0126); coupling the supply lumen (370) of the aspiration catheter (4) to a pump (Look ¶ 0126 describing a pump) having control circuitry (64, 66), the control circuitry (64, 66) capable of receiving a signal from the pressure sensor (12) (Look ¶ 0132-0145); and following positioning the aspiration catheter (4) in relation to a thrombus, changing the valve (8) from one of the open state and the closed state to the other of the open state and the closed state such that a change in pressure may be detected by the control circuitry (Look ¶ 0132-0145).
	However, Look fails to teach the pressure sensor configured to connect through the first connector through an intermediate connector connected to the first connector, and an elongate vacuum line extending from the proximal connector to the vacuum source, with the valve distal a connection of the vacuum line to the proximal connector of the pressure sensor. Ressemann teaches a method for aspiration in a subject comprising an aspiration catheter (100) (Ressemann Annotated Fig. 5A below), a first connector (184), a proximal connector (188-1), and an intermediate connector (192-1), wherein a pressure sensor (192) is configured to connect through the first connector (184) through the intermediate connector (192-1) connected to the first connector (184), and an elongate vacuum line (188-2) extending from the proximal connector (188-1) to a vacuum source (188), with a valve (189-1) distal a connection of the vacuum line to the proximal connector (188-1) of the pressure sensor (192), the configuration for having dedicated connection paths for aspiration and irrigation (Ressemann Annotated Fig. 5A below; ¶ 0142).
	Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pressure sensor, valve and first connector of Look such that the pressure sensor is configured to connect through the first connector through an intermediate connector connected to the first connector, and an elongate vacuum line extending from the proximal connector to the vacuum source, with the valve distal a connection of the vacuum line to the proximal connector of the pressure sensor, the similar embodiment as disclosed by Ressemann for having dedicated connection paths for aspiration and irrigation (Ressemann Annotated Fig. 5A below; ¶ 0142).


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Re Claims 2 and 3, Look in view of Ressemann teach all of the limitations of Claim 1. Look further teaches wherein the step of changing comprises changing the valve from the closed state to the open state; and the method further comprising the step of changing the valve from the open state to the closed state (Look ¶ 0134).

Re Claim 4, Look in view of Ressemann teach all of the limitations of Claim 1. Look teaches wherein the step of changing comprises changing the valve from the open state to the closed state (Look ¶ 0134).

Re Claim 5, Look in view of Ressemann teach all of the limitations of Claim 1. Look teaches wherein the control circuitry causes the pump to change from a non-operating condition to an operating condition (Look ¶ 0134).

Re Claim 6, Look in view of Ressemann teach all of the limitations of Claim 1. Look teaches wherein the control circuitry causes the pump to change from an operating condition to a non-operating condition (Look ¶ 0134).

Re Claim 7, Look in view of Ressemann teach all of the limitations of Claim 1. Look teaches the method further comprising moving the aspiration catheter while the valve is in the open state (Look ¶ 0141).

Re Claim 8, Look teaches a method for aspirating thrombus in a subject (Look Fig. 31; ¶ 0116-0117), comprising: providing an aspiration catheter (4) comprising a supply lumen (370), an aspiration lumen (330) (Look Figs. 32 and 43), and a first connector (22) hydraulically coupled to the proximal end of the aspiration lumen (330) (Look Fig. 43; ¶ 0126); providing a pressure sensor (12) having an internal passageway (42) and comprising a distal connector (46) configured to hydraulically couple to the first connector (22) (Look Fig. 44C; ¶ 0127-0128), a proximal connector (38) configured to couple to a vacuum source (6) (Look ¶ 0126-0127), and a valve (8) disposed between the distal connector (46) and the proximal connector (38) of the pressure sensor, the valve (8) having an open state and a closed state (Look Fig. 43; ¶ 0126-0127); coupling the pressure sensor (12) to the first connector of the aspiration catheter (4) (Look Fig. 43; ¶ 0126); coupling the pressure sensor (12) to the vacuum source (6) (Look Fig. 43; ¶ 0126); coupling the supply lumen (370) of the aspiration catheter (4) to a pump (Look ¶ 0126 describing a pump) having control circuitry (64, 66), the control circuitry (64, 66) capable of receiving a signal from the pressure sensor (12) (Look ¶ 0132-0145); inserting at least a distal portion of the aspiration catheter (4) into the vasculature of a subject near or adjacent a thrombus (Look Figs. 45A-D); and changing the valve (8) from one of the open state and closed state to the other of the open state and closed state such that a change in pressure may be detected by the control circuitry (Look ¶ 0132-0145).
	However, Look fails to teach the pressure sensor configured to connect through the first connector through an intermediate connector connected to the first connector, and an elongate vacuum line extending from the proximal connector to the vacuum source, with the valve distal a connection of the vacuum line to the proximal connector of the pressure sensor. Ressemann teaches a method for aspiration in a subject comprising an aspiration catheter (100) (Ressemann Annotated Fig. 5A above), a first connector (184), a proximal connector (188-1), and an intermediate connector (192-1), wherein a pressure sensor (192) is configured to connect through the first connector (184) through the intermediate connector (192-1) connected to the first connector (184), and an elongate vacuum line (188-2) extending from the proximal connector (188-1) to a vacuum source (188), with a valve (189-1) distal a connection of the vacuum line to the proximal connector (188-1) of the pressure sensor (192), the configuration for having dedicated connection paths for aspiration and irrigation (Ressemann Annotated Fig. 5A above; ¶ 0142).
	Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pressure sensor, valve and first connector of Look such that the pressure sensor is configured to connect through the first connector through an intermediate connector connected to the first connector, and an elongate vacuum line extending from the proximal connector to the vacuum source, with the valve distal a connection of the vacuum line to the proximal connector of the pressure sensor, the similar embodiment as disclosed by Ressemann for having dedicated connection paths for aspiration and irrigation (Ressemann Annotated Fig. 5A below; ¶ 0142).

Re Claims 9 and 10, Look in view of Ressemann teach all of the limitations of Claim 8. Look teaches wherein the step of changing comprises changing the valve from the closed state to the open state; and the method further comprising the step of changing the valve from the open state to the closed state (Look ¶ 0134).

Re Claim 11, Look in view of Ressemann teach all of the limitations of Claim 8. Look teaches wherein the step of changing comprises changing the valve from the open state to the closed state (Look ¶ 0134).

Re Claim 12, Look in view of Ressemann teach all of the limitations of Claim 8. Look teaches wherein the control circuitry causes the pump to change from a non-operating condition to an operating condition (Look ¶ 0134).

Re Claim 13, Look in view of Ressemann teach all of the limitations of Claim 8. Look teaches wherein the control circuitry causes the pump to change from an operating condition to a non-operating condition (Look ¶ 0134).

Re Claim 14, Look in view of Ressemann teach all of the limitations of Claim 8. Look teaches the method further comprising moving the aspiration catheter while the valve is in the open state (Look ¶ 0141).

Re Claim 15, Look teaches a method for aspirating thrombus in a subject (Look Fig. 31; ¶ 0116-0117), comprising: providing an aspiration catheter (4) comprising: a supply lumen (370) and an aspiration lumen (330) (Look Figs. 32 and 43), the supply lumen (370) having a proximal end, a distal end and a wall (394) (as seen in Look Fig. 31), the aspiration lumen (330) having a proximal end and an open distal end (412) (as seen in Look Fig. 32); an orifice (390) at or adjacent the distal end of the supply lumen (370), in fluid communication with an interior of the aspiration lumen (330), the orifice (390) located proximally of the open distal end of the aspiration lumen (330), wherein the orifice (390) is configured to create a jet when pressurized fluid is pumped through the supply lumen (370) when a distal end of the aspiration catheter (4) is immersed within an aqueous environment (Look ¶ 0117); and a first connector (22) hydraulically coupled to the proximal end of the aspiration lumen (330) (Look Fig. 43; ¶ 0126); providing a pressure sensor (12) having an internal passageway (42) and comprising a distal connector (46) configured to hydraulically couple to the first connector (22) (Look Fig. 44C; ¶ 0127-0128), a proximal connector (38) configured to couple to a vacuum source (6) (Look ¶ 0126-0127), and a valve (8) disposed between the distal connector (46) and the proximal connector (38) of the vacuum source (6), the valve (8) having an open state and a closed state (Look Fig. 43; ¶ 0126-0127).
	Look further teaches coupling the distal connector (46) of the pressure sensor (12) to the first connector (22) of the aspiration catheter (4) (Look Fig. 43; ¶ 0126); coupling the proximal connector (38) of the pressure sensor (12) to the vacuum source (6) (Look Fig. 43; ¶ 0126); coupling the supply lumen (370) of the aspiration catheter (4) to a pump (Look ¶ 0126 describing a pump) having control circuitry (64, 66), the control circuitry (64, 66) capable of receiving a signal from the pressure sensor (12) (Look ¶ 0132-0145); inserting at least a distal portion of the aspiration catheter (4) into the vasculature of a subject near or adjacent a thrombus (Look Figs. 45A-D); and changing the valve (8) from one of the open state and closed state to the other of the open state and closed state such that a change in pressure may be detected by the control circuitry (Look ¶ 0132-0145).
	However, Look fails to teach the pressure sensor configured to connect through the first connector through an intermediate connector connected to the first connector, and an elongate vacuum line extending from the proximal connector to the vacuum source, with the valve distal a connection of the vacuum line to the proximal connector of the pressure sensor. Ressemann teaches a method for aspiration in a subject comprising an aspiration catheter (100) (Ressemann Annotated Fig. 5A above), a first connector (184), a proximal connector (188-1), and an intermediate connector (192-1), wherein a pressure sensor (192) is configured to connect through the first connector (184) through the intermediate connector (192-1) connected to the first connector (184), and an elongate vacuum line (188-2) extending from the proximal connector (188-1) to a vacuum source (188), with a valve (189-1) distal a connection of the vacuum line to the proximal connector (188-1) of the pressure sensor (192), the configuration for having dedicated connection paths for aspiration and irrigation (Ressemann Annotated Fig. 5A above; ¶ 0142).
	Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the pressure sensor, valve and first connector of Look such that the pressure sensor is configured to connect through the first connector through an intermediate connector connected to the first connector, and an elongate vacuum line extending from the proximal connector to the vacuum source, with the valve distal a connection of the vacuum line to the proximal connector of the pressure sensor, the similar embodiment as disclosed by Ressemann for having dedicated connection paths for aspiration and irrigation (Ressemann Annotated Fig. 5A below; ¶ 0142).

Re Claim 16, Look in view of Ressemann teach all of the limitations of Claim 15. Look teaches wherein the step of changing comprises changing the valve from the closed state to the open state (Look ¶ 0134).

Re Claim 17, Look in view of Ressemann teach all of the limitations of Claim 15. Look teaches the method further comprising the step of changing the valve from the open state to the closed state (Look ¶ 0134).

Re Claim 18, Look in view of Ressemann teach all of the limitations of Claim 15. Look teaches wherein the control circuitry causes the pump to change from a non-operating condition to an operating condition (Look ¶ 0134).

Re Claim 19, Look in view of Ressemann teach all of the limitations of Claim 15. Look teaches wherein the control circuitry causes the pump to change from an operating condition to a non-operating condition (Look ¶ 0134).

Re Claim 20, Look in view of Ressemann teach all of the limitations of Claim 15. Look teaches the method further comprising moving the aspiration catheter while the valve is in the open state (Look ¶ 0141).

Response to Arguments
Applicant’s arguments filed 02/10/2025 with respect to claim objections have been fully considered and are persuasive. Due to clarifying amendments, claim objections of Claims 1, 8 and 15 are hereinafter withdrawn. 

Applicant’s arguments with respect to Claims 1-20 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.

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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.

Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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/WILLIAM R FREHE/Examiner, Art Unit 3783               
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783