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 .
Response to Amendment
This Office action is responsive to the amendments filed 11/19/2025, Claim 22 has been amended and claims 26-29 have been newly added. Claims 1-29 are currently pending in the application.
Response to Arguments
Applicant’s arguments, see pg. 9, filed 11/19/2025, with respect to the objection to claim 22 have been fully considered and are persuasive. The objection has been withdrawn.
Applicant’s arguments, see pg. 9-15, filed 04/29/2025, with respect to the rejection of the claims under 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant first argues, that it would not have been obvious to one of ordinary skill in the art to have modified the method of Adams in view of the teachings of Marchand to include the step of “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” because doing so would have changed a principle of operation of the device and method of Adams and required a substantial reconstruction and redesign of the method of Adams.
The Examiner disagrees. It is first noted that principle of operation of the device and method of Adams is capturing and removing thrombus material. In the method of Adams, the medical device (10, see Fig. 1) is intended to be positioned downstream of a thrombus (64), withdrawn proximally when resheathed (see [0048], [0050] and [0054]) and is designed to capture segments of thrombus within the basket (see [0053]). Adams simply does not teach withdrawing the medical device through the thrombus to segment the thrombus into smaller pieces. However, modifying the method of Adams to include this step, as taught by Marchand, would result in an enhancement in the ability to capture and remove thrombus material. Therefore, the combination would not render the device of Adams unsuitable for it intended purpose nor would it fundamentally change the principle of operation.
Applicant further argues, see pg. 12-14, that it would not have been obvious to modify the arms of Adams to be sharp in view of the teachings of Marchand and that even if it were, the resulting method would not have resulted in the features recited in claim 1.
The Examiner disagrees. 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).
In this case, Marchand teaches the proximal end (206, see Fig. 4-5) of a thrombus removal device (202) including sharp arms (410A, 410B) and defining a mouth (414) for enhancing the device’s ability to detach thrombus from a vessel wall (see Marchand [0007] and [0108]). Marchand teaches this feature in combination with the step of withdrawing the device proximally through a thrombus to segment the thrombus into smaller pieces (see Marchand [0175]).
The Examiner maintains that 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 Adams to include the step of withdrawing the medical device proximally through the thrombus such that the plurality of arms segment the thrombus into smaller pieces since doing so would have enhanced the device’s ability to capture and remove thrombus from a blood vessel.
Claim Rejections - 35 USC § 112
Claim 29 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 29 recites the limitation “the plurality of arms define a cross-sectional area less than 10 percent of a cross-sectional area of the proximal mouth” which renders the scope of the claim indefinite since it is unclear if each arm of the plurality of arms has a cross-sectional area that is less than 10 percent of the cross-sectional area of the proximal mouth or if the plurality of arms collectively define a cross-sectional area that is less than 10 percent of the cross-sectional area of the proximal mouth. It is further unclear from the specification (see [0145] and Fig. 2B) how Applicant intended the plurality of arms defining a cross-sectional area to be construed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-7, 9-16 and 18-29 are rejected under 35 U.S.C. 103 as being unpatentable over Adams et al. (US 2002/0004667) in view of Marchand et al. (US 2017/0112514).
Regarding Claims 1, 3, 7, 12, and 16, Adams discloses a method comprising: positioning an expandable element (12, see Fig. 1) of a medical device (10) within a blood vessel distally of a thrombus (the device is deployed downstream of a thrombus 64, see Fig. 1 and [0052]), the medical device comprising: an elongated support member (16); and the expandable element disposed on the elongated support member (see Fig. 1), the expandable element comprising an expandable element proximal portion (22) and an expandable element distal portion (20), wherein the expandable element is configured to expand radially outward from a delivery configuration to a deployed configuration (see [0036] and Fig. 1-2), 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 (frame 22 has openings capable of receiving emboli that are captured in filter 20, see Fig. 1 and [0053]), and wherein the expandable element proximal portion defines a plurality of arms (34) extending to the elongated support member (see Fig. 1).
Adams fails to teach positioning a retrieval catheter defining a retrieval catheter inner lumen proximally of the thrombus; proximally withdrawing the medical device through the thrombus and into the retrieval catheter 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 wherein the retrieval catheter defines a funnel at its distal end.
Marchand, in the same field of art, teaches a related method including the steps of positioning a retrieval catheter (106, see Fig. 25E-25H) defining a retrieval catheter inner lumen proximally of a thrombus (2200) and proximally withdrawing a medical device (202) through the thrombus and into the retrieval catheter (see Fig. 25E-25H), wherein the retrieval catheter defines a funnel (1708) at its distal end. Marchand further discloses that the arms (410A, 410B, see Fig. 5) are sharp to enhance the device’s ability to detach thrombus from the vessel wall (see [0007] and [0108]).
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 Adams 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 a practitioner to use the device to detach thrombus from a vessel wall and capture 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 Adams so that the plurality of arms are sharp, as taught by Marchand, since doing so would enhance the devices capability of detaching thrombus from a vessel wall (see [0007]).
Regarding the limitation “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”, the combination of Adams and Marchand teach this limitation because the plurality of arms in the device of Adams would be sharp and therefore segment a thrombus into smaller pieces which would then be captured within the basket.
Regarding Claim 2, Adams further discloses wherein each arm of the plurality of arms (34, see Fig. 1) includes a first section and a second section that meet at a joint, 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 (each strut 34 has a first portion that is angled upward and a second portion that is angle downward in Fig. 1 such that the two sections are not parallel to each other and meet at a joint, i.e., a bend). This interpretation of a joint appears to be consistent with Applicant’s use of the term in the specification and figures (see Specification [0174]-[0176] and Fig. 9C).
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 Adams and Marchand teaches the method of claim 3, but fails to expressly teach wherein 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 would have been obvious to one of ordinary skill in the art to cause the expandable element to dehydrate at least part of the thrombus as it is collapsed and withdrawn into the retrieval catheter since doing so would make it easier to compress and 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 the extraction device 202 is proximally withdrawn thrombus material is distributed distally into the basket, see Fig. 25A-25H).
Regarding Claims 9 and 18, Adams 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 (the device is deployed downstream of a thrombus 64, see Fig. 1-2 and [0052]).
Regarding Claims 10 and 19, Adams further discloses delivering a therapeutic agent distally to the thrombus to at least partially break down the thrombus (a lysing agent can be delivered to reduce the size of the emboli within the filter 20 or struts 34, see [0053]).
Regarding Claims 11 and 20, Marchand further teaches the expandable element proximal portion maintains apposition with a vessel wall of the blood vessel as the expandable element is moved proximally through the thrombus (when the extraction device is proximally retracted, the proximal portion “maintains sufficient radial force on the venous vessel wall to core and separate the vascular thrombus portion at full expansion”, see [0016]).
Regarding Claim 21, Adams further discloses the plurality of arms includes at least three arms (there appears to be 6 struts 34, see Fig. 1).
Regarding Claim 22, Adams 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. 1).
Regarding Claim 23, the combination of Adams 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, Adams further discloses the elongated support member extends through a radial center of the expandable element (see Fig. 1).
Regarding Claim 25, the combination of Adams and Marchand teaches 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 (since Marchand teaches proximally withdrawing the expandable element through thrombus and the proximal portion segmenting the thrombus, it follows that the smaller pieces of thrombus would pass through the spaces between struts 34 in the device of Adams).
Regarding claim 26, Marchand further teaches wherein proximally withdrawing the medical device through the thrombus includes: while the expandable element is in the deployed configuration and while the expandable element maintains apposition with a vessel wall of the blood vessel, proximally withdrawing the medical device through the thrombus (when the extraction device is proximally retracted, the proximal portion “maintains sufficient radial force on the venous vessel wall to core and separate the vascular thrombus portion at full expansion”, see [0016]).
Regarding claim 27, Adams further discloses wherein 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, wherein in deployed configuration, the expandable element distal portion defines a second axial length along a central longitudinal axis of the medical device, and wherein the first axial length is less than the second axial length (a first axial length and a second axial length can arbitrarily be chosen along the proximal portion 22 and distal portion 20 such that the first length is less than the second length, see Fig. 1).
Regarding claim 28, the combination of Adams and Marchand teaches the method of claim 1, wherein 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 (the plurality of arms of Adams are symmetric about the longitudinal axis of the device, see Fig. 1 of Adams, and as modified by Marchand, the sharp arms of Adams would cause the thrombus to break into smaller pieces that are symmetrical around a longitudinal axis of the device).
Regarding claim 29, the combination of Adams and Marchand teaches the method of claim 1. Adams further teaches wherein the plurality of arms (34, see Fig. 1), collectively and individually, define a cross-sectional area that is less than a cross-sectional area of the proximal mouth taken orthogonal to a central longitudinal axis of the medical device when the expandable element is in the deployed configuration.
Adams fails to expressly teach the cross-sectional area defined by the arms is less than 10 percent of a cross-sectional area of the proximal mouth.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the plurality of arms of Adams and Marchand to define a cross-sectional area that is less than 10 percent of a cross-sectional area of the proximal mouth since it has been 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” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Adams and Marchand would not operate differently with the claimed dimensions and since the plurality of arms are designed to have a cross-sectional area, individually and collectively, that is less than a cross-sectional area of the proximal mouth, the device would function appropriately having the claimed dimensions. Further, applicant places no criticality on the range claimed, indicating simply that the plurality of arms “may” be configured to be within the claimed ranges (specification pp. [0145]).
Claims 8 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Adams in view of Marchand, as applied to claims 7 and 16 above, and further in view of Lowinger (US 2017/0215900).
Regarding claims 8 and 17, the combination of Adams and Marchand teaches the method of claims 7 and 16, 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 Adams 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 tapper 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 Adams 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])
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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