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 .
Benefit
Applicant claims benefit to US Provisional US 63/610,567 (15 December 2023).
Formal Matters
Claims 1-20 are pending and under examination.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim Rejections - 35 USC § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 7-9, and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Deville US 20200093503 (26 March 2020).
Regarding independent claim 1, Deville teaches a control (FIG 22, volume change controller 300; ¶219) configured for use in a system for aspirating thrombus (aspiration thrombectomy system, ¶¶171, 221), the control (300) having an open position and a closed position (¶219; claims 1, 15), the control comprising:
a control body (barrel body 310; ¶219) having an inlet (FIG 22, input orifice 314) and an outlet (FIG 22, purge conduit 322, ¶219) connected by an aspiration passage (FIG 22, interior 311; ¶219);
a valve (FIG 22, pump orifice 316 (vacuum valve), purge orifice 318 (vent valve [see annotated FIG 22]; claims 1, 5) disposed at least partially within the aspiration passage (311; ¶219),
an occlusion member (FIG 22, plunger body [see annotated FIG 22]; ¶219) disposed at least partially within the control body (310), the occlusion member (FIG 22, plunger body; ¶219) being configured to enter the valve (316/318) and obstruct flow of a fluid through the aspiration passage (FIG 22; ¶¶219, 220);
a control interface (FIG 22, plunger handle [see annotated FIG 22], ¶220) configured to be manipulated by a user (¶21) to move the control between the open and closed positions (¶¶219, 220; claims 1, 18, 19); and
a return mechanism (¶221) configured to facilitate movement of the occlusion member (FIG 22, plunger body; ¶219) into the valve (¶220).
An “occlusion member” is broadly interpreted, consistent with the specification. The specification discloses “the occlusion member may comprise a piston structure having a plunger, a sliding component, one or more anvils of a pinch valve, or a rotary valve” (¶44). “Occlusion member 444 may comprise a piston structure 445 formed by a plunger 446 carried by a piston body 448. The occlusion member 444 may also comprise a plug, a rigid slider, a swinging separator, a rotary valve, or other structure configured to obstruct the passage 438” (¶64).
A “return mechanism” is broadly interpreted, consistent with the specification. The specification discloses that a “return mechanism” may be defined by function. At ¶8, a “return mechanism” is disclosed as configured to facilitate movement of the occlusion member into the valve.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed, although not necessarily in a single embodiment.
Although, embodiment 300 of Deville discloses the claimed control comprising the recited components, Deville does not use the same terminology of the claims and some of Deville’s components shown in the figures do not have corresponding text references or element numbers. Accordingly, the broadest reasonable interpretation standard was used to determine the correlative structures and functions between Deville and the claims of the application.
Deville specifically addresses different aspects of the claim in different embodiments. For example, the term “orifice” is used in embodiment 300 to describe the purge orifice 318 and the vacuum pump orifice 316. However, in other embodiments these two configurations are termed a vent valve 650 and vacuum valve 620 and the terms vent valve and vacuum valve are also used in the claims (1, 3-5, 7, 9-11, and 15-21). In spite of the mixed terminology used in the various embodiments of Deville, embodiment 300 reasonably comports with the broadest reasonable interpretation standard for the control device, as recited in claim 1 of the application. The structures of Deville also comport with the required functions in the “configured to” clauses of the claim because Deville’s control is expressly configured for use in a system for aspirating thrombus and Deville expressly teaches that the disclosed controllable vacuum solves the problem of incomplete clot removal where a thrombus may get stuck at the distal end of a catheter.
The controller is configured to open and close the vent and vacuum valves in a repeated cycle that allows clots to be dislodged (¶¶21-22) under the control of a surgeon (¶21). A person of ordinary skill in the art, seeking to better control thrombus clogs in aspiration catheters would reasonably consult Deville’s various embodiments as solutions to be adapted to the individual use-case or anatomic area of interest. Deville’s embodiments comprising various species of generic “controls”, “control body”, “occlusion members”, “control interfaces” and “return mechanisms” that can be incorporated alongside Deville’s other device and system components (same general location and interaction within the aspiration thrombectomy system, ¶171) using known assembly methods without redesigning Deville’s core device (aspiration thrombectomy systems). Because Deville’s different embodiments address the same engineering problem (aspiration thrombectomy systems and their components) and the proposed modifications or substitutions between embodiment components are mechanically compatible and implemented by routine engineering practices (as set forth by Deville), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings, notwithstanding the differences in terminology within the same reference.
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Annotated FIG 22
Regarding claim 2, Deville teaches the control of claim 1, as set forth above, wherein the return mechanism (¶221) is: disposed between the occlusion member (FIG 22, plunger body; ¶219) and the control body (FIG 22, 310); or adjacent a first end of the occlusion member (FIG 22, plunger body; ¶219) opposite a second end of the occlusion member (FIG 22, plunger body; ¶219) that enters the valve (FIG 22, pump orifice 316 (vacuum valve), purge orifice 318 (vent valve [see annotated FIG 22]; claims 1, 5)).
Regarding claim 3, Deville teaches the control of claim 1, as set forth above.
Deville does not teach wherein the return mechanism comprises a return spring in embodiment 300.
Deville teaches a return spring as an example of a bias device 12 in the embodiment of controller 10 (¶181). As set forth above in claim 1, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed in aspiration thrombectomy systems, although not necessarily in a single embodiment.
Deville teaches aspiration thrombectomy systems comprising multiple biasing devices, including bias device 12 (FIGs 1, 2, 4, 8; ¶181) and bias device 130 (FIGs 16, 17; ¶196). Biasing device 130 operates along with plunger 120 (¶196). At ¶181, Deville teaches that “this configuration for the bias device 12 is merely exemplary and any return spring or similar mechanical device can be placed and used”. In ¶196, Deville uses the word “spring” synonymously with biasing device 130, as springs are generally understood by one of ordinary skill in the art to be biasing devices “the bias device 130 (e.g., in the form of a spring that is stretched)” (¶196). Accordingly, Deville’s multiple embodiments of bias devices contain comparable devices that were improved the same way as the claimed invention.
One of ordinary skill in the art could have applied the known improvement of the addition of a biasing device, such as bias device 12 (FIG 2) or alternatively bias device 130 (FIG 16) in the same way to the base controller device in the aspiration thrombectomy system and the results would have been predictable based on the teachings, suggestions, and motivations of Deville as a whole.
Regarding claim 7, Deville teaches the control of claim 1, as set forth above, wherein the return mechanism comprises a pneumatic connection (pneumatically actuated vacuum booster 100, ¶197).
As set forth above in claim 1, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed in aspiration thrombectomy systems, although not necessarily in a single embodiment.
Regarding claim 8, Deville teaches the control of claim 7, as set forth above, wherein the control body (FIG 16, handle 20/compression-actuator 40 (compare FIGs 1, 2, 7, 8)) comprises a pressure chamber (pressure chamber 118; ¶196), wherein the pressure chamber (118) is adjacent a first end of the occlusion member (plunger body 130) opposite a second end of the occlusion member (130) that is configured to enter the valve (FIG 16, connection 140).
Regarding claim 9, Deville teaches the control of claim 7, as set forth above, wherein the control interface comprises a venting actuator (“the control carried out by the motor controller assembly 550 has a selection of user-actuated buttons … one button causes both vacuum and venting to be shut off”, ¶246).
As set forth above in claim 1, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed in aspiration thrombectomy systems, although not necessarily in a single embodiment.
Regarding claim 11, Deville teaches the control of claim 1, as set forth above, wherein the control interface comprises a slider (“remote control 678 is a mechanical slide switch”, ¶287) or a button (“controller 560 is a microcontroller that has a user interface (UI) comprising user inputs that include, for example, control buttons to operate the aspiration thrombectomy system 400” (¶232).
As set forth above in claim 1, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed in aspiration thrombectomy systems, although not necessarily in a single embodiment.
One of ordinary skill in the art could have applied the known improvement of the addition of a switch as taught in multiple embodiments of Deville, such as an on/off switch for a vacuum (¶282), a mechanical slide switch (¶287), a two-position switch with a button (¶287), “a passive switch (simple mechanical switch) or an active switch (e.g. capacitive, pressure, magnetic)” (¶287) in the same way to the base controller device in the aspiration thrombectomy system and the results would have been predictable based on the teachings, suggestions, and motivations of Deville as a whole.
Regarding claim 12, Deville teaches the control of claim 1, as set forth above, further comprising an electrical switch (“an active switch (e.g. capacitive, pressure, magnetic). In such a case, the switch is powered by wires through the extension line 674” (¶287) configured to be activated by the occlusion member when the occlusion member is moved to the open position (“an active switch (e.g. capacitive, pressure, magnetic)” (¶287).
One of ordinary skill in the art could have applied the known improvement of the addition of a switch as taught in multiple embodiments of Deville, such as an on/off switch for a vacuum (¶282), a mechanical slide switch (¶287), a two-position switch with a button (¶287), “a passive switch (simple mechanical switch) or an active switch (e.g. capacitive, pressure, magnetic) … the switch is powered by wires through the extension line 674” (¶287), instead of or in addition to a manual switch configuration, in the base controller device as set forth in the aspiration thrombectomy system and the results would have been predictable based on the teachings, suggestions, and motivations of Deville.
An “occlusion member” is broadly interpreted, consistent with the specification. The specification discloses “the occlusion member may comprise a piston structure having a plunger, a sliding component, one or more anvils of a pinch valve, or a rotary valve” (¶44). “Occlusion member 444 may comprise a piston structure 445 formed by a plunger 446 carried by a piston body 448. The occlusion member 444 may also comprise a plug, a rigid slider, a swinging separator, a rotary valve, or other structure configured to obstruct the passage 438” (¶64).
Regarding claim 13, Deville teaches the control of claim 12, as set forth above, wherein the electrical switch (¶¶282, 284) is configured to activate a vacuum source (“controls include turning on and off the vacuum motor 614 … (e.g. on/off switch for a vacuum)”, ¶282).
As set forth above in claim 1, it would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed in aspiration thrombectomy systems, although not necessarily in a single embodiment.
Regarding independent claim 14, Deville teaches a control (FIG 22, volume change controller 300; ¶219) configured for use in a system for aspirating thrombus (aspiration thrombectomy system, ¶¶171, 221), the control (300) having an open position and a closed position (¶219; claims 1, 15), the control comprising:
a control body (barrel body 310; ¶219) having an longitudinal axis (FIG 22, ¶219) and configured to be moved between an open position and a closed position (¶¶219, 220); and having an aspiration passage (FIG 22, interior 311; ¶219);
a handle having a longitudinal axis transverse to the longitudinal axis of the control body (FIG 22, plunger handle [see annotated FIG 22]);
a control interface (FIG 22, plunger handle [see annotated FIG 22], ¶220) configured to be manipulated by a user (¶21) to move the control between the open and closed positions (¶220; claims 1, 18, 19);
a valve (FIG 22, pump orifice 316 (vacuum valve), purge orifice 318 (vent valve [see annotated FIG 22]; claims 1, 5) disposed at least partially within the aspiration passage (311; ¶219);
wherein the valve is configured to obstruct flow of a fluid through the aspiration passage when the control is in the closed position (¶¶219, 220); and
wherein the valve is configured to allow flow through the aspiration passage when the control is in the open position (¶¶219, 220).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed, although not necessarily in a single embodiment.
Although, embodiment 300 of Deville discloses the claimed control comprising the recited components, Deville does not use the same terminology of the claims and some of Deville’s components shown in the figures do not have corresponding text references or element numbers. Accordingly, the broadest reasonable interpretation standard was used to determine the correlative structures and functions between Deville and the claims of the application.
Deville specifically addresses different aspects of the claim in different embodiments. For example, the term “orifice” is used in embodiment 300 to describe the purge orifice 318 and the vacuum pump orifice 316. However, in other embodiments these two configurations are termed a vent valve 650 and vacuum valve 620 and the terms vent valve and vacuum valve are also used in the claims (1, 3-5, 7, 9-11, and 15-21). In spite of the mixed terminology used in the various embodiments of Deville, embodiment 300 reasonably comports with the broadest reasonable interpretation standard for the control device, as recited in claim 14 of the application. The structures of Deville also comport with the required functions in the “configured to” clauses of the claim because Deville’s control is expressly configured for use in a system for aspirating thrombus and Deville expressly teaches that the disclosed controllable vacuum solves the problem of incomplete clot removal where a thrombus may get stuck at the distal end of a catheter.
The controller is configured to open and close the vent and vacuum valves in a repeated cycle that allows clots to be dislodged (¶¶21-22) under the control of a surgeon (¶21). A person of ordinary skill in the art, seeking to better control thrombus clogs in aspiration catheters would reasonably consult Deville’s various embodiments as solutions to be adapted to the individual use-case or anatomic area of interest. Deville’s embodiments comprising various species of generic “controls”, “control body”, and “control interfaces” that can be incorporated alongside Deville’s other device and system components (same general location and interaction within the aspiration thrombectomy system, ¶171) using known assembly methods without redesigning Deville’s core device (aspiration thrombectomy systems). Because Deville’s different embodiments address the same engineering problem (aspiration thrombectomy systems and their components) and the proposed modifications or substitutions between embodiment components are mechanically compatible and implemented by routine engineering practices (as set forth by Deville), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings, notwithstanding the differences in terminology within the same reference.
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Annotated FIG 22
Regarding claim 15, Deville teaches the control of claim 14, as set forth above, wherein an angle between the longitudinal axis of the handle and the longitudinal axis of the control body is within a range of approximately 45° to approximately 170°, or approximately 70° to approximately 150°, or approximately 90° to approximately 135°, or a range with any two of the foregoing as endpoints (FIG 22).
Figure 22 of Deville shows a plunger handle at about a 90 degree angle transverse/perpendicular to the longitudinal axis of the control body 300.
Applicant’s attention is also drawn to MPEP 2144.04. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 16, Deville teaches the control of claim 14, as set forth above, wherein the control body comprises a notch adjacent the handle configured to receive a purlicue of a hand of a user (FIG 22; “the surgeon presses the plunger 320 inwards” ¶219). A “purlicue” is interpreted in the broadest reasonable interpretation based on the context, as there are several definitions, as being the space or distance between the extended forefinger and thumb.
Figure 22 of Deville shows a plunger handle comprising notches adjacent the handle configured to receive the fingers within the notch so that the thumb of a human hand may be used to depress the plunger, as is typically, routinely, and commonly used in plunger operation. See also, ¶219.
Regarding independent claim 17, Deville teaches a control (FIG 22, volume change controller 300; ¶219) configured for use in a system for aspirating thrombus (aspiration thrombectomy system, ¶¶171, 221), the control comprising:
a control body (barrel body 310; ¶219) having an inlet (FIG 22, input orifice 314) and an outlet (FIG 22, purge conduit 322, ¶219) connected by an aspiration passage (FIG 22, interior 311; ¶219) configured to direct a fluid through the control (¶219);
a sliding component (FIG 22, plunger 320; ¶219) configured to control a flow of fluid through the aspiration passage and configured for direct communication with a hand of a user (“the surgeon presses the plunger 320 inwards” ¶219);
wherein the control may be placed in a first position by moving the sliding component in a first direction (FIG 22, “[i]n a first portion of the inwards motion, a surface of the plunger 320 seals off the pump orifice 316 to stop the application of vacuum to the vacuum channel 3”, ¶219); and
wherein the control may be placed in a second position by moving the sliding component in a second direction opposite the first direction (“[r]eversal of the plunger reverses the column shift and reapplies vacuum to the vacuum channel 3”, ¶219).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed, although not necessarily in a single embodiment.
Although, embodiment 300 of Deville discloses the claimed control comprising the recited components, Deville does not use the same terminology of the claims and some of Deville’s components shown in the figures do not have corresponding text references or element numbers. Accordingly, the broadest reasonable interpretation standard was used to determine the correlative structures and functions between Deville and the claims of the application.
Deville specifically addresses different aspects of the claim in different embodiments. For example, the term “orifice” is used in embodiment 300 to describe the purge orifice 318 and the vacuum pump orifice 316. However, in other embodiments these two configurations are termed a vent valve 650 and vacuum valve 620 and the terms vent valve and vacuum valve are also used in the claims (1, 3-5, 7, 9-11, and 15-21). In spite of the mixed terminology used in the various embodiments of Deville, embodiment 300 reasonably comports with the broadest reasonable interpretation standard for the control device, as recited in claim 17 of the application. The structures of Deville also comport with the required functions in the “configured to” clauses of the claim because Deville’s control is expressly configured for use in a system for aspirating thrombus and Deville expressly teaches that the disclosed controllable vacuum solves the problem of incomplete clot removal where a thrombus may get stuck at the distal end of a catheter.
The controller is configured to open and close the vent and vacuum valves in a repeated cycle that allows clots to be dislodged (¶¶21-22) under the control of a surgeon (¶21). A person of ordinary skill in the art, seeking to better control thrombus clogs in aspiration catheters would reasonably consult Deville’s various embodiments as solutions to be adapted to the individual use-case or anatomic area of interest. Deville’s embodiments comprising various species of generic “controls”, “control body”, and “control interfaces” that can be incorporated alongside Deville’s other device and system components (same general location and interaction within the aspiration thrombectomy system, ¶171) using known assembly methods without redesigning Deville’s core device (aspiration thrombectomy systems). Because Deville’s different embodiments address the same engineering problem (aspiration thrombectomy systems and their components) and the proposed modifications or substitutions between embodiment components are mechanically compatible and implemented by routine engineering practices (as set forth by Deville), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings, notwithstanding the differences in terminology within the same reference.
Regarding claim 18, Deville teaches the control of claim 17, as set forth above.
Embodiment 300 of Deville does not expressly teach wherein the inlet comprises a first luer fitting and the outlet includes a second luer fitting.
Deville teaches aspiration thrombectomy system 600 (FIG 47, ¶280) wherein the inlet comprises a first luer fitting (“the proximal manifold connector assembly 670 comprises a male luer lock fitting 672 connected to manifold 630” ¶281; see also ¶287) and the outlet includes a second luer fitting (“the distal end of the proximal manifold connector assembly 670 that connected to the ROAR catheter 660 comprises a luer lock part that connects to another luer lock part on the ROAR catheter 660”, ¶287).
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed, although not necessarily in a single embodiment.
Although, embodiment 300 of Deville discloses the claimed control comprising the recited components, Deville does not use the same terminology of the claims and some of Deville’s components shown in the figures do not have corresponding text references or element numbers. Accordingly, the broadest reasonable interpretation standard was used to determine the correlative structures and functions between Deville and the claims of the application.
Deville specifically addresses different aspects of the claim in different embodiments. For example, the term “orifice” is used in embodiment 300 to describe the purge orifice 318 and the vacuum pump orifice 316. However, in other embodiments these two configurations are termed a vent valve 650 and vacuum valve 620 and the terms vent valve and vacuum valve are also used in the claims (1, 3-5, 7, 9-11, and 15-21). The structures of Deville also comport with the required functions in the “configured to” clauses of the claim because Deville’s control is expressly configured for use in a system for aspirating thrombus and Deville expressly teaches that the disclosed controllable vacuum solves the problem of incomplete clot removal where a thrombus may get stuck at the distal end of a catheter.
Deville teaches aspiration thrombectomy system 600 comprising controller 700 (¶256) operatively connected to each of vacuum valve 620 and vent valve 650 where the controller selectively opens and closes the vacuum and vent valves 620, 650 as set forth in ¶256. Deville teaches that configurations for the valves include spool valves, pinch valves, rotary valves, and rotary valve having a pintel design (¶256). Deville teaches that vacuum valve 620 is connected to a vacuum input 632 of manifold 630 (¶253). Deville teaches that this connection can be direct or through a conduit such as silicone tubing (¶253).
One of ordinary skill in the art would be aware that a plunger apparatus such as those taught in other embodiments of Deville, such as plunger 120 (¶206) or plunger 320 (¶219) could be connected to manifold 630 by direct connection, as in aspiration thrombectomy system 300, or through a conduit such as silicone tubing (¶253) in order to generate suction within a locally communicating lumen when activated (¶¶206, 219). Deville teaches that vacuum tube 2 (comprising vacuum channel 3) in the embodiment of aspiration thrombectomy system 1 “can be of many materials, including silicone” (¶172).
Deville generally teaches that a controller is configured to open and close the vent and vacuum valves in a repeated cycle that allows clots to be dislodged (¶¶21-22) under the control of a surgeon (¶21). A person of ordinary skill in the art, seeking to better control thrombus clogs in aspiration catheters would reasonably consult Deville’s various embodiments as solutions to be adapted to the individual use-case or anatomic area of interest.
In embodiment 600, Deville is silent on the specific manner of connection of the vacuum valve 620 and the vacuum input 632 of manifold 630, but does expressly teach that the connection can be direct or through a conduit (¶253). Given that aspiration thrombectomy system 300 teaches a direct connection between vacuum valve 316 and the structure responsible for generating suction (plunger 320) and aspiration thrombectomy system 600 teaches a connection through a conduit, such as a silicone tube, including one comprising a luer lock, as taught at ¶¶281, 287, one of ordinary skill in the art would be reasonably apprised of Deville’s teaching, suggestion, and motivation to permit obvious variant configurations of connections between the controller and vacuum systems in the aspiration thrombectomy systems. Accordingly, one of ordinary skill in the art would reasonably understand that the embodiments of Deville can be incorporated alongside Deville’s other device and system components (same general location and interaction within the overall aspiration thrombectomy system) using known assembly methods without redesigning Deville’s core device (aspiration thrombectomy systems). Because Deville’s different embodiments address the same engineering problem (aspiration thrombectomy systems and their components) and the proposed modifications or substitutions between embodiment components are mechanically compatible and implemented by routine engineering practices (as set forth by Deville), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings, notwithstanding the various embodiments or differences in terminology within the same reference.
Regarding claim 19, Deville teaches the control of claim 17, as set forth above, wherein the sliding component comprises a tactile surface for engaging the hand of a user (FIG 22; “the surgeon presses the plunger 320 inwards” ¶219). Figure 22 of Deville shows a plunger handle comprising notches adjacent the handle configured to receive the fingers within the notch so that the thumb of a human hand may be used to depress the plunger, as is typically, routinely, and commonly used in plunger operation. See also, ¶219.
Regarding claim 20, Deville teaches the control of claim 19, as set forth above, wherein the tactile surface comprises one or more ridges protruding from the surface of the sliding component (FIG 22).
Figure 22 of Deville shows a plunger handle comprising notches adjacent the handle configured to receive the fingers within the notch so that the thumb of a human hand may be used to depress the plunger, as is typically, routinely, and commonly used in plunger operation. See also, ¶219. The phrases “tactile surface” and “one or more ridges protruding from the surface of the sliding component” is not expressly defined in the specification and there is no disclosure of criticality of the limitations. Accordingly, the terms have been interpreted under the Broadest Reasonable Interpretation Standard (BRI) to included a surface that is connected with a sense of touch (tactile) and the plunger handle notches interpreted as ridges which protrude from the surface of the sliding component, as the plunger 320 is configured in FIG 22. These notches/ridges are structurally distinct from the portion of the sliding component of plunger 320 that is associated with and movably slidable within input orifice 314 (FIG 22, ¶219).
Claims 4-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Deville US 20200093503 (26 March 2020) in view of Vale et al., US 20240277914 (22 August 2024, benefit to 22 February 2023).
Regarding claim 4, Deville teaches the control of claim 3, as set forth above.
Deville does not expressly state that the return spring comprises a compression spring, an extension spring, a torsion spring, a wave disk spring, a volute spring, a spiral spring, or leaf spring.
Deville teaches a return spring as an example of a bias device 12 in the embodiment of controller 10 (¶181).
Vales teaches a cyclic aspiration system (Abstract) for removal of occlusions or clots in a vessel (¶2). Vale teaches a reciprocating plunger 940 is spring-loaded 915 (FIG 9, spring 915; ¶54)
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed, although not necessarily in a single embodiment, as set forth above in the rationale applicable to claims 1 and 3.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Deville and Vale, given that the prior art included each element claimed, although not necessarily in a single reference. Deville and Vale teach in the same field of endeavor, aspiration thrombectomy systems.
Although Deville discloses the claimed base aspiration thrombectomy system (control, control body, valve, occlusion member, control interface, and return mechanism), Deville does not expressly disclose that the return spring comprises a compression spring, an extension spring, a torsion spring, a wave disk spring, a volute spring, a spiral spring, or leaf spring.
Vale specifically addresses a reciprocating plunger 940 that is spring-loaded 915 (FIG 9, spring 915; ¶54). Because the embodiments in Deville include a return spring as an example of a bias device 12 in the embodiment of controller 10 (¶181), a person of ordinary skill in the art, seeking to provide reciprocating control of the plunger would reasonably consult Vale’s spring-loaded reciprocating plunger solution (¶54). Vale’s spring-loaded reciprocating plunger solution can be incorporated alongside Deville’s embodiments (same general location along vacuum tubing 2, comprising vacuum channel 3) using known assembly methods without redesigning Deville’s core delivery path.
Because the references address the same engineering problem (optimizing control of vacuum aspiration in thrombectomies) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a return spring compatible with a reciprocating plunger), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 5, Deville teaches the control of claim 1, as set forth above.
Deville does not expressly teach wherein the return mechanism comprises a solenoid and an engagement pin disposed within the solenoid, wherein the engagement pin is configured to push the occlusion member into the valve upon activation of the solenoid.
Deville teaches that the return mechanism can comprise solenoid-driven pinch valves (¶244).
Vales teaches a cyclic aspiration system (Abstract) for removal of occlusions or clots in a vessel (¶2). Vale teaches appositive pressure pulse mechanism comprising a solenoid as a first linear displacement mechanism 788 and a solenoid as a second linear displacement mechanism 786 with a gating mechanism comprising a pin 790 and plunger 740 (FIGs 7A, 7B; ¶52) where the first solenoid 788 controls the extent of the compressive force imposed on the flexible inlet tubing 110 by varying the extent of the advancement of the plunger 740 such that pin 790 “acts as a valve (e.g. pinch valve) controlling passage of vacuum pressure” (¶52).
Accordingly, Vale teaches wherein the return mechanism (FIGs 7A, 7B) comprises a solenoid 788 and an engagement pin 790 disposed within the solenoid (second linear displacement mechanism 786), wherein the engagement pin 790 is configured to push the occlusion member (plunger 740) into the valve upon activation of the solenoid (FIGs 7A, 7B, ¶52).
An “occlusion member” is broadly interpreted, consistent with the specification. The specification discloses “the occlusion member may comprise a piston structure having a plunger, a sliding component, one or more anvils of a pinch valve, or a rotary valve” (¶44). “Occlusion member 444 may comprise a piston structure 445 formed by a plunger 446 carried by a piston body 448. The occlusion member 444 may also comprise a plug, a rigid slider, a swinging separator, a rotary valve, or other structure configured to obstruct the passage 438” (¶64).
A “return mechanism” is broadly interpreted, consistent with the specification. The specification discloses that a “return mechanism” may be defined by function. At ¶8, a “return mechanism” is disclosed as configured to facilitate movement of the occlusion member into the valve.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the multiple embodiments of Deville, given that the reference as a whole teaches each element claimed, although not necessarily in a single embodiment, as set forth above in the rationale applicable to claim 1.
It would have been obvious to one having ordinary skill in the art as of the effective filing date of the invention to combine the teachings of Deville and Vale, given that the prior art included each element claimed, although not necessarily in a single reference. Deville and Vale teach in the same field of endeavor, aspiration thrombectomy systems.
Although Deville discloses the claimed base aspiration thrombectomy system (control, control body, valve, occlusion member, control interface, and return mechanism), Deville does not disclose wherein the return mechanism comprises a solenoid and an engagement pin disposed within the solenoid, wherein the engagement pin is configured to push the occlusion member into the valve upon activation of the solenoid.
Vale specifically addresses wherein the return mechanism (FIGs 7A, 7B) comprises a solenoid 788 and an engagement pin 790 disposed within the solenoid (second linear displacement mechanism 786), wherein the engagement pin 790 is configured to push the occlusion member (plunger 740) into the valve upon activation of the solenoid (FIGs 7A, 7B, ¶52). Because the embodiments in Deville include a return mechanism comprising a solenoid-driven pinch valves (¶244), a person of ordinary skill in the art, seeking to control or gate the solenoid-driven displacement mechanism in Deville’s architecture would reasonably consult Vale’s displaceable gating mechanism solution. Vale’s linear displacement mechanisms 788/786 can be incorporated alongside Deville’s embodiments (same general location along vacuum tubing 2, comprising vacuum channel 3) using known assembly methods without redesigning Deville’s core delivery path.
Because the references address the same engineering problem (optimizing control of vacuum aspiration in thrombectomies) and the proposed modifications are mechanically compatible and implemented by routine engineering practices (adding a solenoid and a pin to act as a displaceable gating mechanism), a person of ordinary skill in the art before the effective filing date of the claimed invention would have had a reasonable expectation of success in combining these teachings.
Regarding claim 6, Deville modified by Vale teaches the control of claim 5, as set forth above.
Vales teaches wherein the solenoid or the engagement pin is affixed to the occlusion member (FIGs 7A, 7B; ¶52).
Regarding claim 10, Deville modified by Vale teaches the control of claim 5, as set forth above.
Vale teaches the control further comprising a spring configured to move the occlusion member out of the valve (FIGs 8A, 8B, spring-loaded pin head 890; ¶ 53).
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Buck et al., US 11,457,936 (4 October 2022) teaches a catheter system for treating thromboembolic disease.
Buck et al., US 20210315596 (14 October 2021) teaches a catheter system for treating thromboembolic disease.
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/CHERIE M POLAND/Examiner, Art Unit 3771
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