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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/26/2026 has been entered.
Claims 1, 4-6, 8, 12, 17, and 27 have been amended. Claims 3, 7, 11, 20, 26, and 29 have been cancelled. Claims 30-34 have been newly added. Claims 1-2, 4-6, 8-10, 12-15, 17-19, 21-25, 27-28, and 30-34 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 9, filed 05/26/2026, with respect to the rejection of claim 29 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The amendment to cancel claim 29 renders the objection moot. Therefore, the rejection of claim 29 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see pg. 9-14, filed 05/26/2026, with respect to the rejections of the claims under 35 U.S.C. 103 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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 27 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 27 recites “the expandable element distal portion defines a second axial length…the second axial length measured from a proximalmost end to a distalmost end of the expandable element” which renders the scope of the claim indefinite because it is unclear how the expandable element distal portion can define (i.e., mark the limits of) a length extending from the proximalmost end to a distalmost end of the expandable element if there is also a proximal portion. It is unclear if the second length is intended to refer to the length of the of the expandable element or the length of the expandable element distal portion. For examination purposes, this limitation has been interpreted as the expandable element has a second length measured from a proximalmost end to a distalmost end of the expandable element.
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.
Claims 1- 2, 4-6, 9-10, 12-15, 18-19, 21-25, 27-28, and 30-33 are rejected under 35 U.S.C. 103 as being unpatentable over Razack et al. (US 20090292307 A1) in view of Marchand et al. (US 20170112514).
Regarding Claims 1 and 12, Razack discloses a method (see Fig. 1-6) comprising: positioning an expandable element (12) of a medical device (10) within a blood vessel (50) distally of a thrombus (54), the medical device comprising: an elongated support member (18); and the expandable element disposed on the elongated support member (retrieval portion 12 may be formed from or attached to elongated shaft 18, see [0028]), the expandable element comprising an expandable element proximal portion (22) and an expandable element distal portion (26), wherein the expandable element is configured to expand radially outward from a delivery configuration to a deployed configuration (see Fig. 4-5), and in the deployed configuration, the expandable element tapers in a distal direction along a majority of a length of at least the expandable element distal portion (the retrieval net 26 is tapered along its entire length, see Fig. 3), wherein in the deployed configuration, the expandable element proximal portion defines a proximal mouth configured to receive the thrombus and the expandable element distal portion defines an elongated tapered basket configured to receive at least part of the thrombus (see Fig. 6), and wherein the expandable element proximal portion defines a plurality of arms (22) extending to the elongated support member (spring arms extend towards elongated shaft 18, see Fig. 3); and proximally withdrawing the medical device through the thrombus (see Fig. 6) such that the plurality of arms segments the thrombus into smaller pieces that are captured in the basket as the expandable element is moved proximally through the thrombus and as the thrombus moves through the proximal mouth and into the basket, wherein the plurality of arms are rigid such that the plurality of arms cuts through the thrombus to segment the thrombus into smaller pieces as the expandable element is moved proximally through the thrombus.
It is noted that the claim language “the plurality of arms are rigid such that the plurality of arms cuts” implies that the rigidity of the arms is what causes the plurality of arms to cut. It is further noted that Applicant discloses that the expandable element (and therefore, the plurality of arms) may be made of a variety of metals or plastic (see [0120] and [0121] of the Specification of the instant application). It is the Examiner’s position that the arms of Razack are rigid and therefore cut through thrombus in the same way as the device of the application since the arms of Razack meet all of the structural limitations of the claim and are made of the same rigid material disclosed by Applicant (i.e., metal or plastic, see [0030] of Razack).
It follows that when the expandable element is moved proximally through the thrombus as disclosed by Razack (see Fig. 6), the arms cut through the thrombus to segment the thrombus into smaller pieces that are captured in the basket as claimed.
Razack fails to disclose positioning a retrieval catheter including a funnel at a distal end of the retrieval catheter within a blood vessel proximally of a thrombus, the retrieval catheter defining a retrieval catheter inner lumen; expanding the funnel of the retrieval catheter within the blood vessel proximally of the thrombus; while the expandable element proximal portion is in the deployed configuration and maintains apposition with a vessel wall of the blood vessel and while the funnel remains proximal of the thrombus, proximally withdrawing the medical device through the thrombus and towards the funnel and after the smaller pieces of thrombus have been captured in the basket, proximally withdrawing the medical device including the thrombus into the retrieval catheter inner lumen.
Marchand, in the same field of art, teaches a related method including the steps of positioning a retrieval catheter (106, see Fig. 23A-25H) including a funnel (1708) at a distal end of the retrieval catheter within a blood vessel (2202) proximally of a thrombus (2200, see Fig. 23C), the retrieval catheter defining a retrieval catheter inner lumen, expanding the funnel of the retrieval catheter within the blood vessel proximally of the thrombus (see Fig. 23B-23C), and proximally withdrawing an expandable element (202) through the thrombus and into the retrieval catheter after the clot has been captured in the basket (208, see Fig. 25E-25H). Marchand further teaches the expandable element proximal portion maintains apposition with a vessel wall of the blood vessel as it is withdrawn to ensure separation of the thrombus from the vessel wall (see [0016]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Razack to include the step of positioning a retrieval catheter proximally of the thrombus and withdrawing the medical device proximally through a thrombus and into the retrieval catheter, as taught by Marchand, since doing so would allow for the capture of any remaining uncollected fragments of thrombus which may be extruded as the device is collapsed and withdrawn (see Marchand [0180]).
It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method of Razack so that expandable element proximal portion maintains apposition with the vessel wall as it is withdrawn since doing so would enhance the ability separate thrombus from the vessel wall (see Marchand [0016]).
Regarding Claim 2, Razack further discloses each arm of the plurality of arms includes a first section (32, see Fig. 3) and a second section (34) that meet at a joint (30), and wherein the first section and second section of each arm are angled relative to each other such that the first section and the second section of each arm are not parallel to each other (see Fig. 3).
Regarding Claims 4 and 13, Marchand further teaches wherein the expandable element compresses the at least part of the thrombus received in the basket to reduce a volume of the at least part of the thrombus as the expandable element is withdrawn proximally into the retrieval catheter (extraction device 202 is collapsed as it is proximally withdrawn to compress the thrombus within the device, see [0012]).
Regarding Claims 5 and 14, the combination of Razack and Marchand teaches the method of claims 1 and 12, but fails to expressly teach the expandable element dehydrates the at least part of the thrombus received in the basket by expelling water from the at least part of the thrombus as the expandable element is withdrawn proximally into the retrieval catheter.
It is noted however that Marchand discloses the expandable element is collapsed and the thrombus compressed as the expandable element is proximally withdrawn into the retrieval catheter (see [0012]).
It is examiner’s position that compressing the expandable element necessarily removes excess water. Alternatively, It would have been obvious to one of ordinary skill in the art to dehydrate at least part of the thrombus through collapsing the expandable element as it is withdrawn into the retrieval catheter since doing so would make it easier to remove the thrombus for extraction.
Regarding Claims 6 and 15, Marchand further teaches the expandable element distributes the at least part of the thrombus distally within the basket as the expandable element is withdrawn proximally into the retrieval catheter (as extraction device 202 is proximally withdrawn thrombus material is distributed distally into the basket, see Fig. 25A-25H).
Regarding Claims 9 and 18, Razack further discloses moving the expandable element distally through the thrombus while the expandable element is in the delivery configuration; and deploying the expandable element to the deployed configuration distally of the thrombus (see Fig. 4-5).
Regarding Claims 10 and 19, the combination of Razack and Marchand teaches the method of claim 1. Razack fails to teach delivering a therapeutic agent distally to the thrombus to at least partially break down the thrombus.
Marchand teaches delivering a therapeutic agent distally to the thrombus to at least partially break down the thrombus (a thrombolytic agent can be delivered before, during, or after thrombus extraction, see [0014]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Razack to include the step of delivering a therapeutic agent distally of a thrombus, as taught by Marchand, since doing so would reduce the size of the embolic material.
Regarding Claim 21, Razack further discloses wherein the plurality of arms (22) includes at least three arms (see Fig. 3).
Regarding Claim 22, Razack further discloses the expandable element defines a central longitudinal axis, and wherein the plurality of arms is evenly distributed around the central longitudinal axis (see Fig. 3).
Regarding Claim 23, the combination of Razack and Marchand teaches as the expandable element is moved proximally through the thrombus, a proximal end of each arm stays centered within the blood vessel (Marchand teaches that the expandable element maintains apposition on the vessel wall as is moved proximally through the thrombus, see [0016], which would therefore cause the arms to stay centered within the vessel). It is noted that this is consistent with Applicant's disclosure that apposition of the device against the vessel wall helps center the expandable element in the vessel (see [0139]).
Regarding Claim 24, Razack further discloses wherein the elongated support member extends through a radial center of the expandable element (although not shown in the figures, Razack discloses that penetrating portion 40 can be a part of the elongated shaft 18, see [0031], and in this configuration, the elongated support member 18 would extend through a radial center of the expandable element).
Regarding Claim 25, Razack further discloses as the expandable element proximal portion moves through the thrombus, the smaller pieces of thrombus pass through spaces between adjacent arms of the plurality of arms (as discussed with respect to claim 1, the plurality of arms 22 segment thrombus into smaller pieces that are captured by the net 26, therefore, pieces of thrombus must pass through the spaces between the arms to enter the basket, see Fig. 6).
Regarding Claim 27, Razack further discloses in the deployed configuration, the expandable element proximal portion of the expandable element including the plurality of arms defines a first axial length along a central longitudinal axis of the medical device, the first axial length measured from a proximalmost end to a distalmost end of the plurality of arms (the arms define a length from proximalmost end near 18 to the distalmost end 30, see Fig. 3), wherein in the deployed configuration, the expandable element distal portion defines a second axial length along a central longitudinal axis of the medical device, the second axial length measured from a proximalmost end to a distalmost end of the expandable element (as discussed above with respect to the rejection of the claim under 35 U.S.C. 112b, this limitation has been interpreted as the expandable element has a second length measured from a proximalmost end to a distalmost end of the expandable element), and wherein the first axial length is less than the second axial length (the length of the proximal portion defined by the arms is less than the length of the entire retrieval portion 12, see Fig. 3).
Regarding Claim 28, Razack further discloses proximally withdrawing the medical device through the thrombus such that the plurality of arms segments the thrombus into smaller pieces that are captured in the basket as the expandable element is moved proximally through the thrombus and as the thrombus moves through the proximal mouth and into the basket includes: proximally withdrawing the medical device through the thrombus such that the plurality of arms segments the thrombus into smaller pieces that are symmetrical around a longitudinal axis of the medical device, the smaller pieces being captured in the basket as the expandable element is moved proximally through the thrombus and as the thrombus moves through the proximal mouth and into the basket (as discussed with respect to claim 1, the plurality of arms 22 segment thrombus into smaller pieces that are captured by the net 26, and since the arms are located symmetrically about the longitudinal axis of the medical device, pieces of thrombus that enter through the spaces between the arms would also be symmetrical about the longitudinal axis of the medical device, see Fig. 6).
Regarding Claim 30, Razack further discloses the plurality of arms have radial spacing between adjacent arms of the plurality of arms to enable the smaller pieces of thrombus to move distally into the basket rather than being retained between the adjacent arms as the medical device is proximally withdrawn through the thrombus (arms 22 have radial spacing between them which allows smaller pieces of thrombus to move into distally into net 26 as shown in Fig. 6).
Regarding Claim 31, Razack further discloses the plurality of arms form a plurality of pie-shaped channels into the expandable element distal portion through which the smaller pieces of thrombus pass as the medical device is proximally withdrawn through the thrombus (the spaces between the arms 22 form a plurality of pie-shaped channels and the thrombus material enters the net 26 through these channels, see Fig. 3 and 6).
Regarding Claim 32, Razack further discloses each respective arm of the plurality of arms is straight between a proximalmost end of the respective arm and a distalmost end of the respective arm (arms 22 are straight between the proximalmost end near 18 and the distalmost end 30, see Fig. 3).
Regarding Claim 33, Razack further discloses a distalmost end of the elongated support member terminates proximally of the expandable element (elongated shaft 18 terminates proximally of the retrieval portion 12, see Fig. 3).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Razack in view of Marchand, as applied to claims 1 and 12 above, and further in view of Lowinger (US 2017/0215900).
Regarding claims 8 and 17, the combination of Razack and Marchand teaches the method of claims 1 and 12, but fails to teach wherein the funnel defines a variable taper that applies a variable force to the expandable element as the expandable element is withdrawn proximally through the funnel of the retrieval catheter.
Lowinger, in the same field of art, discloses a funnel (118, see Fig. 2) with a variable taper which allows for better engagement with the inside of an anatomical passageway (see [0019]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the funnel of Razack and Marchand so that it has a funnel shape, as taught by Lowinger, since doing so would allow the funnel to better engage the inside of an anatomical passageway.
Regarding the taper applying "a variable force to the expandable element as the expandable element is withdrawn proximally through the funnel of the retrieval catheter". The variable taper of Lowinger in the funnel of Razack and Marchand would meet this limitation since the change in diameter would cause a different amount of force to be applied to the expandable element as it is withdrawn. It is noted that this is consistent with how Applicant discloses the function of the variable taper (see Specification [0214])
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Razack in view of Marchand, as applied to claim 1 above, and further in view of Tsugita (US 6,142,987).
Regarding Claim 34, the combination of Razack and Marchand teaches the method of claim 1, but fails to teach positioning a guidewire distally of the thrombus, wherein positioning the expandable element within the blood vessel distally of the thrombus includes advancing the expandable element over the guidewire after the guidewire is positioned distally of the thrombus.
Tsugita teaches a related method of deploying a expandable element (22, see Fig. 1H) distal of a clot (100) including positioning a guidewire (30) distally of the thrombus and then advancing the expandable element over the guidewire after the guidewire is positioned distally of the thrombus (see col. 5, line 63 – col. 6, line 8)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the method of Razack and Marchand to include the step of positioning a guidewire distally of the thrombus and advancing the expandable element over the guidewire after the guidewire is positioned distally of the thrombus, as taught by Tsugita, since using a guidewire would aid in tracking the device to the target site.
Conclusion
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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