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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/30/2025 has been entered.
Allowable Subject Matter
Claims 19 and 20 are allowed.
The following is an examiner’s statement of reasons for allowance: Regarding claims 19 and 20, the prior art of record fails to teach or render obvious a second tube as claimed, in combination with the limitations of the first tube, and further in claim 20, the limitations of the third tube. In particular, the prior art does not teach or render obvious the use of separate tube structures in between the plurality of retrieval devices capable of engaging the proximal and distal collars thereof, ultimately contributing to the expansion via elongate wire.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant's arguments filed 10/22/2025 with respect to claim 1 have been fully considered but they are not persuasive. Applicant argues on pages 12-14 that the claimed features of "the first tube having a distal facing surface that faces the proximal facing surface of the proximal collar of the first retrieval device" and "the first retrieval device being configured to transition towards or to a fully expanded state at least partially by withdrawing the elongate wire proximally to cause a proximal end of the proximal collar to push against the distal end of the first tube" are not found in the device as modified by Brady. However, Applicant does not argue that these claimed features are not taught by Brady. Rather, applicant argues that Brady fails to meet other limitations of the claim (namely "a plurality of elongate clot capturing elements that each has a proximal end directly attached to the proximal collar and a distal end directly attached to the distal collar, there being no other collar in the first retrieval device located between the proximal and distal collars". Applicant argues that because Brady fails to teach the claimed arrangement of the collars and the elongate clot capturing elements, that is cannot be used to teach the limitations regarding the first tube. Examiner does not agree with this position. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). As such, Brady is not required to teach each and every claim limitation in order to be applied as a teaching reference. Regardless of the fact that Brady teaches an additional collar in between the proximal and distal collars, it still would have been obvious to one of ordinary skill in the art at the time of filing to employ the deployment mechanism including the first tube taught by Brady in order to assist with the deployment of the first retrieval device taught by Clark. Therefore, applicants’ argument is not persuasive.
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.
Claim(s) 1, 3-4, 9-13, 15-18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Clark (US 2020/0323547) in view of Brady et al. (US 2022/0071646).
Regarding claim 1, Clark discloses a clot retrieval assembly (FIG 1A) comprising: an elongate wire (10) having a proximal end (Proximal end shown in FIG 1A), a distal end (Distal end towards the retrieval device shown in FIG 1A), and a longitudinal axis (Extending along the longitudinal axis of the device as shown in FIGs 2A-3); a first retrieval device (20) comprising: a distal collar (21, FIG 1C) attached to the elongate wire ([0069]; “collar 21 fixed stationary to the elongate wire 10”); a proximal collar (22) mounted on the elongate wire (by being positioned on and around the wire, [0069]) and having a longitudinal through opening through which the elongate wire passes (FIG 1C, [0069] discloses that 22 is slidable on the elongate wire 10, therefore there is understood to be a through opening for the wire to pass through the collar), the proximal collar having a proximal facing surface (Proximal facing surface 22a, FIG 1B); a plurality of elongate clot capturing elements (62, 82, 92, 102, 122, 152, 162, 172, or 202) that each has a proximal end (62a) directly attached to the proximal collar (FIG 8A-8C, 8E) and a distal end (62b) directly attached to the distal collar (FIG 8A-8C and 8E, also demonstrated in the alternative embodiments of unitary construction), there being no other collar located in the first retrieval device between the proximal and distal collars (see FIGs 8A-8C and exemplary embodiments FIGs 10-18 where only elongate clot capturing elements exist between the proximal and distal collars), each of the plurality of elongate capturing elements having a proximal end section and a distal end section (Each of the clot capturing elements have a respective proximal end section closest to the proximal collar and a respective distal end section closest to the distal collar), each pair of neighboring elongate clot capturing elements is circumferentially separated from one another by an elongate slot that extends continuously between the proximal and distal collars (61, [0094-0096]; or equivalent slots shown in alternative embodiments), the proximal collar, distal collar, and the plurality of elongate clot capturing elements are made from a single piece of material (FIG 8A, [0094] discloses the proximal/distal collar and capturing elements are formed of a single nitinol tube which is laser cut to form the slots 61); the first retrieval device being configured to transition from an unexpanded state (FIG 8A) to a fully expanded state (FIG 8C), in the unexpanded state no portion of the plurality of elongate clot capturing elements is located over the proximal collar (FIG 8A), in the fully expanded state at least some of the proximal portions of the plurality of elongate clot capturing elements are inverted and residing over the proximal collar (FIG 8C). Clark further discloses that transitioning from the unexpanded state to the expanded state is accomplished by self-expansion after removing a radially constraining force of delivery catheter 30 ([0083-0086]).
Clark is silent regarding a first tube mounted on the elongate wire and having a longitudinal through opening through which the elongate wire passes, the first tube having a distal facing surface that faces the proximal facing surface of the proximal collar of the first retrieval device, none of the plurality of elongate clot capturing elements being directly attached to the first tube; and the first retrieval device being configured to transition towards or to a fully expanded state at least partially by withdrawing the elongate wire proximally to cause a proximal end of the proximal collar to push against the distal end of the first tube.
However, Brady et al. teaches a clot retrieval assembly (FIG 37, [0575]) having an elongate wire (971) with a stop on the distal end thereof (973), a distal collar (978), a proximal collar (979), a plurality of elongate clot capturing elements (974) and a first tube (977) mounted on the elongate wire (See proximal end of 971 extending through the back end of tube 977, therefore it is understood that the tube is mounted on the elongate wire) and having a longitudinal through opening through which the elongate wire passes (In order for wire 971 to pass therethrough, it is understood that a longitudinal opening exists through the tube), none of the plurality of elongate clot capturing elements being directly attached to the first tube (Because clot capturing elements 974 are directly attached to proximal collar 979, not tube 977), the first tube having a distal facing surface that faces a proximal facing surface of the proximal collar of the first retrieval device (FIG 37 shows an interface of contact between the distal end of 977 and the proximal end of 979) wherein transition form an unexpanded state (not shown) to a fully expanded state (FIG 37) is achieved at least partially by withdrawing the elongate wire proximally to cause a proximal end of the proximal collar to push against the distal end of the first tube ([0564-0567] wherein [0570] discloses “this principle of operation is applicable to all the actuatable designs disclosed herein and is intended to be combined with all of the elsewhere disclosed engaging basket features, such as inlet mouths, scaffolding regions, reception spaces, stepped diameters, variable radial force, inner tubular members, and capture nets”, therefore it is understood to apply to the device of FIG 37 as well). Brady further discloses that this mechanism of actuation can be used in conjunction with or alternatively to self-expansion of the plurality of elongate clot capturing elements ([0567]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Clark to comprise a first tube mounted on the elongate wire and having a longitudinal through opening through which the elongate wire passes, the first tube having a distal facing surface that faces the proximal facing surface of the proximal collar of the first retrieval device and the first retrieval device being configured to transition towards or to a fully expanded state at least partially by withdrawing the elongate wire proximally to cause a proximal end of the proximal collar to push against the distal end of the first tube, as taught by Brady, for the purpose of achieving the predictable result of reliably transitioning the first retrieval device form the unexpanded state to the fully expanded state using a deployment technique commonly known in the art for being used in substitution or in conjunction with the technique taught by Clark. In the device as modified, none of the plurality of elongate clot capturing elements are directly attached to the first tube because they remain directly attached to the proximal collar only.
Regarding claim 3, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified by Brady further discloses the proximal collar is not attached to a distal end of the first tube (Because the distal end of the tube is movable relative to the proximal collar. The elements can come into contact with one another but they are not attached i.e. they are still independently movable).
Regarding claim 4, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. The device as modified by Brady further discloses the first retrieval device is configured to transition towards or to a fully expanded state at least partially by withdrawing the elongate wire proximally while the first tube is held stationary ([0564 and 0567] of Brady. [0570] discloses the operation of the embodiment of FIG 37 is understood to be the same as what is disclosed for the previously discussed embodiment).
Regarding claim 9, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses the plurality of elongate clot capturing elements are laser cut from a tubular member ([0094]).
Regarding claim 10, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses one or more of the plurality of elongate clot capturing elements has a varying width and/or a varying thickness (Embodiment of FIG 8E, [0099]).
Regarding claim 11, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses the distal end section of one or more of the plurality of elongate clot capturing elements has a cross-sectional area greater than the cross-sectional area of the respective one or more proximal end section of the one or more of the plurality of elongate clot capturing elements (Embodiment of FIG 8E, [0099] shows a greater width at distal end 62b and therefore a greater cross sectional area).
Regarding claim 12, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses the distal end section of one or more of the plurality of elongate clot capturing elements has a thickness greater than a thickness of the respective one or more proximal end section of the one or more of the plurality of elongate clot capturing elements (Embodiment of FIG 9A-9B shows a greater thickness at the distal ends relative to a more proximal section 69, [0100-0103]).
Regarding claim 13, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses the distal end section of one or more of the plurality of elongate clot capturing elements has a width greater than a width of the respective one or more proximal end section of the one or more of the plurality of elongate clot capturing elements (Embodiment of FIG 8E, [0099] shows a greater width at distal end 62b).
Regarding claim 15, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses the proximal end section of each of the plurality of elongate clot capturing elements is arranged helically with respect to a longitudinal axis of the first retrieval device (Embodiment of FIG 15A, [0127-0128]).
Regarding claim 16, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses the plurality of elongate clot capturing elements are configured to self-expand to place the first retrieval device in at least a partially expanded state (Clark teaches the plurality of elongate clot capturing elements are self expandable, [0071, 0097]. The device as modified retains the self expanding characteristics because Brady teaches the use of the pull wire and self expanding properties in order to deploy the retrieval device).
Regarding claim 17, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 1. Clark further discloses none of the plurality of elongate clot capturing elements overlap with one another when the first retrieval device is in the unexpanded state (Each embodiment of the unexpanded state shows the capturing elements do not overlap on another).
Regarding claim 18, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 17. Clark further discloses at least some of the plurality of elongate clot capturing elements overlap with one another when the first retrieval device is in the fully expanded state (FIGs 8D and 10E shows overlap of the capturing elements in the fully expanded state).
Regarding claim 21, Clark discloses a clot retrieval assembly (FIG 1A) comprising: an elongate wire (10) having a proximal end (Proximal end shown in FIG 1A), a distal end (Distal end towards the retrieval device shown in FIG 1A), and a longitudinal axis (Extending along the longitudinal axis of the device as shown in FIGs 2A-3); a first retrieval device (20) comprising: a distal collar (21, FIG 1C); a proximal collar (22) mounted on the elongate wire (by being positioned on and around the wire, [0069]) and having a longitudinal through opening through which the elongate wire passes (FIG 1C, [0069] discloses that 22 is slidable on the elongate wire 10, therefore there is understood to be a through opening for the wire to pass through the collar), the proximal collar having a proximal facing surface (Proximal facing surface 22a, FIG 1B); a plurality of elongate clot capturing elements (62, 82, 92, 102, 122, 152, 162, 172, or 202) that each has a proximal end (62a) directly attached to the proximal collar (FIG 8A-8C, 8E) and a distal end (62b) directly attached to the distal collar (FIG 8A-8C and 8E, also demonstrated in the alternative embodiments of unitary construction), there being no other collar located in the first retrieval device between the proximal and distal collars (see FIGs 8A-8C and exemplary embodiments FIGs 10-18 where only elongate clot capturing elements exist between the proximal and distal collars), each of the plurality of elongate capturing elements having a proximal end section and a distal end section (Each of the clot capturing elements have a respective proximal end section closest to the proximal collar and a respective distal end section closest to the distal collar), each pair of neighboring elongate clot capturing elements is circumferentially separated from one another by an elongate slot that extends continuously between the proximal and distal collars (61, [0094-0096]; or equivalent slots shown in alternative embodiments), the proximal collar, distal collar, and the plurality of elongate clot capturing elements are made from a single piece of material (FIG 8A, [0094] discloses the proximal/distal collar and capturing elements are formed of a single nitinol tube which is laser cut to form the slots 61); the first retrieval device being configured to transition from an unexpanded state (FIG 8A) to a fully expanded state (FIG 8C), in the unexpanded state no portion of the plurality of elongate clot capturing elements is located over the proximal collar (FIG 8A), in the fully expanded state at least some of the proximal portions of the plurality of elongate clot capturing elements are inverted and residing over the proximal collar (FIG 8C). Clark further discloses that transitioning from the unexpanded state to the expanded state is accomplished by self-expansion after removing a radially constraining force of delivery catheter 30 ([0083-0086]).
Clark is silent regarding the distal collar is not attached to the elongate wire and a stop on the distal end or distal end portion of the elongate wire, the stop including a proximal facing surface that faces a distal facing surface of the distal collar, the proximal facing surface of the stop being configured to press against the distal facing surface of the distal collar upon the elongate wire being withdrawn proximally to cause or assist in causing the first retrieval device to transition to or towards the fully expanded state.
However, Brady teaches the distal collar can be attached to the wire or it can be detached from the wire and utilize a distal stop to engage with the distal collar when the wire is pulled ([0573]), the stop including a proximal facing surface that faces a distal facing surface of the distal collar (Proximal end of stop 973 shown in FIG 37 which abuts the distal surface of distal collar 978), the proximal facing surface of the stop being configured to press against the distal facing surface of the distal collar upon the elongate wire being withdrawn proximally to cause or assist in causing the first retrieval device to transition to or towards the fully expanded state (FIGs 35a and 35c, [0564, 0567, 0573] describe the actuation with respect to FIG 35. [0570 and 0575] disclose actuation of the device of FIG 37 would be substantially the same)).
Therefore, it would have been obvious to modify the device of Clark such that the distal collar is not attached to the elongate wire and to have a stop on the distal end or distal end portion of the elongate wire, the stop including a proximal facing surface that faces a distal facing surface of the distal collar, the proximal facing surface of the stop being configured to press against the distal facing surface of the distal collar upon the elongate wire being withdrawn proximally to cause or assist in causing the first retrieval device to transition to or towards the fully expanded state, as taught by Brady, for the purpose of achieving the predictable result of providing an operable attachment between the distal collar and the wire which is disclosed as being interchangeable with a fixed connection, and further providing the benefit such that the wire which used with a distal stop may be used as a guidewire/re-access wire ([0573]).
Clark is further silent regarding a first tube mounted on the elongate wire and having a longitudinal through opening through which the elongate wire passes, the first tube having a distal facing surface that faces the proximal facing surface of the proximal collar of the first retrieval device, none of the plurality of elongate clot capturing elements being directly attached to the first tube; and the first retrieval device being configured to transition towards or to a fully expanded state at least partially by withdrawing the elongate wire proximally to cause a proximal end of the proximal collar to push against the distal end of the first tube.
However, Brady et al. teaches a clot retrieval assembly (FIG 37, [0575]) having an elongate wire (971) with a stop on the distal end thereof (973), a distal collar (978), a proximal collar (979), a plurality of elongate clot capturing elements (974) and a first tube (977) mounted on the elongate wire (See proximal end of 971 extending through the back end of tube 977, therefore it is understood that the tube is mounted on the elongate wire) and having a longitudinal through opening through which the elongate wire passes (In order for wire 971 to pass therethrough, it is understood that a longitudinal opening exists through the tube), none of the plurality of elongate clot capturing elements being directly attached to the first tube (Because clot capturing elements 974 are directly attached to proximal collar 979, not tube 977), the first tube having a distal facing surface that faces a proximal facing surface of the proximal collar of the first retrieval device (FIG 37 shows an interface of contact between the distal end of 977 and the proximal end of 979) wherein transition form an unexpanded state (not shown) to a fully expanded state (FIG 37) is achieved at least partially by withdrawing the elongate wire proximally to cause a proximal end of the proximal collar to push against the distal end of the first tube ([0564-0567] wherein [0570] discloses “this principle of operation is applicable to all the actuatable designs disclosed herein and is intended to be combined with all of the elsewhere disclosed engaging basket features, such as inlet mouths, scaffolding regions, reception spaces, stepped diameters, variable radial force, inner tubular members, and capture nets”, therefore it is understood to apply to the device of FIG 37 as well). Brady further discloses that this mechanism of actuation can be used in conjunction with or alternatively to self-expansion of the plurality of elongate clot capturing elements ([0567]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Clark to comprise a first tube mounted on the elongate wire and having a longitudinal through opening through which the elongate wire passes, the first tube having a distal facing surface that faces the proximal facing surface of the proximal collar of the first retrieval device and the first retrieval device being configured to transition towards or to a fully expanded state at least partially by withdrawing the elongate wire proximally to cause a proximal end of the proximal collar to push against the distal end of the first tube, as taught by Brady, for the purpose of achieving the predictable result of reliably transitioning the first retrieval device form the unexpanded state to the fully expanded state using a deployment technique commonly known in the art for being used in substitution or in conjunction with the technique taught by Clark. In the device as modified, none of the plurality of elongate clot capturing elements are directly attached to the first tube because they remain directly attached to the proximal collar only.
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Clark (US 2020/0323547) in view of Brady et al. (US 2022/0071646), further in view of Mathews (US 2009/0209987).
Regarding claim 14, Clark/Brady disclose the invention substantially as claimed, as set forth above for claim 4.
The deice of Clark/Brady is silent regarding the handle mechanism used to actuate the elongate wire relative to the first tube, specifically regarding an actuation device having a moveable first part to which a proximal end or proximal end section of the elongate wire is coupled, the actuation device having a stationary second part to which a proximal end or a proximal end section of the first tube is coupled.
However, Mathews teaches an actuation device (24, FIG 1-3) having a moveable first part (27, [0045]) to which a proximal end or proximal end section of an elongate wire (26) is coupled ([0045]), the actuation device having a stationary second part (Stationary housing of the actuator) to which a proximal end or a proximal end section of a first tube (12) is coupled (At proximal end 16, [0032]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the device of Clark/Brady to comprise an actuation device having a moveable first part to which a proximal end or proximal end section of the elongate wire is coupled, the actuation device having a stationary second part to which a proximal end or a proximal end section of the first tube is coupled, as taught by Mathews, for the purpose of providing a handle member which can be manipulated by a user to apply tension to the wire and therefore deploy the retrieval device to the expanded state.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE N LABRANCHE whose telephone number is (571)272-9775. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 5712727134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LABRANCHE/Primary Examiner, Art Unit 3771