DETAILED ACTION
Claim 1 is amended. Claim 26 is a newly added claim. A complete action on the merits of pending claims 1-3, 5-21, and 26 appears below.
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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Response to Amendment
Acknowledgment is made to Applicant's amendments filed on 09/17/2026 which are entered. With regards to the claim objection documented in the Non-Final Office Action sent on 06/26/2026, it is overcome through Applicant's amendment and is withdrawn.
Claim Rejections - 35 USC § 102
Claim(s) 1-3, 6-8, and 26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cassell (US 5,827,324 A).
Regarding claim 1, Cassell discloses, an apparatus (Figures 6 and 11, distal protection device (42)) for engaging a thrombus (Figures 6 and 11, stenosis (60)) in a vessel (Figures 6 and 11, blood vessel (62)) (Col. 4, line 28-Col. 5, line 4), comprising:
a catheter (Figure 6, hollow guidewire (44); Col. 4, line 30-36) having a first expandable element (Figures 6-9, inflatable member (52); Col. 4, line 33-40), the catheter further including a plurality of scrapers (Figures 6-1, struts (56); Col. 4, line 40-46; struts (56) (similar to struts (20) in an earlier embodiment, Col. 3, line 7-17, “Upon being inflated, inflatable member 28 preferably drives struts 20 to assume a deployed position in which ends 24 are pivotally or otherwise moved radially away from hollow guidewire 18 to a diameter which approximates the inner diameter of lumen 12. In this way, capturing assembly or filter 17 is deployed distally of stenosis 14 so that stenosis 14 can be severed and fragmented, and the fragments from stenosis 14 are carried by blood flow (indicated by arrow 16) into the basket or chamber formed by the deployed filter 17. Filter 17 is then collapsed and removed from vessel 12 with the fragments contained therein.”) are capable of performing the function of “scraper” as required in the claim when the surgeon/user expands the balloon/inflatable member and moves the balloon/inflatable member backward and forward) attached at a distal end portion to the catheter and extending proximally at least partially alongside the first expandable element (As clearly seen in Figures 6-7 and 11, the struts (56) are indeed attached at a distal end portion to the hollow guidewire/tube/shaft (44) as detailed in Col. 5, line 39-48, and extend proximally alongside inflatable member (52)), the plurality of scrapers each being longer than the first expandable element such that a proximal end portion of the plurality of scrapers extends proximally beyond a proximal end of the first expandable element (As clearly seen in Figures 6-7 and 11, struts (56) are indeed longer than the inflatable member (52) such that a proximal end portion of struts (56) extends proximally beyond a proximal end of inflatable member (52)), the proximal end portion of the plurality of scrapers being unattached to the catheter (Figures 6-7 and 11; Col. 4, line 47-60, detailing deployment of filter (54) which includes struts (56) indeed supports that the proximal end portion of struts (56) is unattached to the catheter) and adapted to be inserted between the thrombus and the vessel (As previously stated, Col. 3, line 7-12, “Upon being inflated, inflatable member 28 preferably drives struts 20 (equivalent to struts (56)) to assume a deployed position in which ends 24 are pivotally or otherwise moved radially away from hollow guidewire 18 to a diameter which approximates the inner diameter of lumen 12.” Thus, struts (56) are capable of performing the function of being inserted between the stenosis (60) and blood vessel (62) as required in the claim when the surgeon/user expands the balloon/inflatable member and moves the balloon/inflatable member backward and forward).
Regarding claim 2, Cassell further discloses, wherein the first expandable element (inflatable member (52)) comprises an inflatable balloon (Col. 5, line 24-27).
Regarding claim 3, Cassell further discloses, wherein the plurality of scrapers (struts (56)) each comprise a shape memory material (Col. 3, line 26-27).
Regarding claim 6, Cassell further discloses, wherein each of the plurality of scrapers (struts (56)) has a width greater than a thickness (Col. 6, line 16-18).
Regarding claim 7, Cassell further discloses, further including a web (Figure 6, mesh or netting portions (58)) interconnecting the plurality of scrapers (struts (56)) (Col. 4, line 44-46).
Regarding claim 8, Cassell further discloses, wherein each of the plurality of scrapers (struts (56)) is adapted to pass into a space between the thrombus (stenosis (60)) and the vessel (blood vessel (62)) without buckling (As previously stated, Cassell explicitly discloses that the struts (56) (equivalent to struts (20) in the first embodiment) are formed of resilient material having shape memory properties (Col. 3, line 26-27). The struts are ribbon-like in cross-section (0.005 inch by 0.020 inch stainless steel ribbon, where width is substantially greater than thickness) and are designed to pivotally deploy radially outward upon inflation of the inflatable member (52) such that their proximal ends (24) move to a diameter which approximates the inner diameter of the vessel lumen (Col. 3, line 7-12, Col. 4, line 47-60, and Col. 6, line 16-18). Cassell further discloses that the struts reliably collapse back against the guidewire shaft upon deflation of the inflatable member without permanent deformation or failure (Col. 3, line 18-25 and Col. 4, line 61-Col. 5, line 4), demonstrating inherent columnar and bending resilience. Because the struts are biased to expand fully to the vessel wall and are formed with a flat, wide ribbon profile that imparts columnar strength in the longitudinal direction while allowing controlled radial movement, they are structurally capable of advancing or sliding their free proximal ends into any available interstitial space or interface between the stenosis/thrombus material and the vessel wall without buckling when the deployed device is moved axially (proximally or back-and-forth) or rotated within the vessel. This capability is inherent to the disclosed structure and materials, as the struts must maintain integrity and controllably contact/approximate the vessel wall under deployment forces and during subsequent manipulation and retrieval in the blood vessel environment).
Regarding claim 26, Cassell further discloses, wherein, with the first expandable element (inflatable member (52)) in an expanded condition (Figures 6-8 and 11; Col. 4, line 47-60 and Col. 5, line 23-27, detailing inflation of inflatable member (52) to the deployed position), the proximal end portion of the plurality of scrapers (struts (56); equivalent to struts (20) in the earlier embodiment) is spaced radially outward from the catheter (hollow guidewire (44)) and extends substantially parallel to a longitudinal axis of the catheter (As clearly seen in Figures 6-8 and 11, and as detailed in Col. 3, line 7-17, “Upon being inflated, inflatable member 28 preferably drives struts 20 to assume a deployed position in which ends 24 are pivotally or otherwise moved radially away from hollow guidewire 18 to a diameter which approximates the inner diameter of lumen 12.” The free proximal ends of struts (56) are thereby spaced radially outward from hollow guidewire (44) to approximate the vessel diameter, while the elongated intermediate portions of the ribbon-like struts (56) necessarily extend along and substantially parallel to the longitudinal axis of the catheter/guidewire between the distal attachment point and the radially expanded proximal ends. This parallel orientation of the intermediate/proximal portions while the expandable element is expanded is inherent to the disclosed deployed basket/filter structure and is capable of performing the function required by the claim).
Claim Rejections - 35 USC § 103
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cassell, in view of Lucas (US 2006/0253145 A1).
Regarding claim 5, Cassell teaches, the first expandable element (inflatable member (52)).
Cassell fails to teach, further including a second expandable element distal of the first expandable element.
Lucas discloses, a device for percutaneous thrombectomy. Lucas teaches, a second expandable element distal of a first expandable element (Figure 4, balloon-tipped catheter (170) with reversibly inflatable balloon member (175) positioned proximal to the thrombus/clot and tines; Paragraph [0038], “…a second reversibly expandable balloon member located on the opposite side of the tines 185, for further vascular containment of clot debris 29.”).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the device of Cassell to add Lucas’s second (distal) balloon/expandable element distal of the first expandable element, as both references and the claimed invention are directed to endovascular thrombus/emboli treatment. 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 device of Cassell to add Lucas’s second (distal) balloon/expandable element distal of the first expandable element, as such a modification would have been predictable, namely, to provide enhanced distal occlusion and protection beyond the filter alone, reducing the risk of emboli traveling downstream (Paragraphs [0038]-[0039] of Lucas).
Claim(s) 16-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pannek (US 5,176,693 A), in view of Berrada (US 2003/0176884 A1).
Regarding claim 16, Pannek discloses, an atherectomy device. Pannek teaches, an apparatus (Figures 1-4B, atherectomy system; Col. 4, line 12-15) for engaging a thrombus (Figures 2A-2B, plaque (10)) in a vessel (Figures 2A-2B, blood vessel (24)) (Col. 4, line 15-20), comprising:
a catheter (Figures 1-4B, hollow guide wire (26); Col. 4, line 25-27) including a distal end portion (Figures 1-4B, cutter (14)) having an expandable element (Figures 2A-4B, balloon (22)) (Col. 4, line 18-27), the catheter including a plurality of scrapers (Figures 3-4B, cutting blades (30)) attached at one end portion to the distal end portion of the catheter (Figures 3-4B, end at grommet (32); Col. 4, line 41-51) and extending at least partially alongside the expandable element (As seen in Figures 3-4B, blades (30) are clearly extending alongside balloon (22)), a second opposite end portion of the plurality of scrapers being attached to the catheter proximal of the expandable element (As seen in Figures 3-4B and discussed in Col. 4, line 41-51, the cutting blades (30) at their proximal end are attached/coupled to end plate (46) on guide wire (26), which is indeed proximal of balloon (22)), wherein the catheter includes a longitudinal space separating the expandable element from the member securing the second opposite end of the plurality of scrapers along the catheter (As best seen in Figure 4B, there is indeed a longitudinal space separating the balloon (22) from end plate (46) along the hollow guide wire (26)).
Pannek fails to teach, that the attachment of the second opposite end portion of the plurality of scrapers to the catheter proximal of the expandable element is occurring through an elastomeric collar connected to the catheter proximal of the expandable element.
Berrada discloses, thrombus capture and embolic protection devices. Berrada teaches, the use of collars/rings/bands (Figures 1-8C, proximal ring (66), (110), (126), or (212); distal ring (64) or (214); & collar (122)) for attaching the ends of flexible filter/scraper-like structures (Figures 1-3, mesh/filter body (70) with strands) to catheter shafts (Paragraphs [0068], [0074], [0087], [0092], [0097], [0108], & [0113]) . Berrada further teaches, elastomeric materials for components and strands in such vascular devices (elastomeric polymers such as polyurethanes, silicone, latex, etc., for flexible attachment and performance) (Paragraph [0148]).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the proximal attachment of the blades/scrapers in Pannek (end plate (46)) by substituting or incorporating an elastomeric collar as taught by Berrada, as both references and the claimed invention are directed to endovascular thrombus/emboli treatment. 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 proximal attachment of the blades/scrapers in Pannek (end plate (46)) by substituting or incorporating an elastomeric collar as taught by Berrada, as such a modification would have been predictable, namely, to provide a flexible, compliant attachment that facilitates deployment, rotation, and collapse around captured material while reducing vessel trauma (Paragraphs [0072]-[0074]). The modification is a simple substitution of one known attachment means (rigid end plate) for another known equivalent attachment means (elastomeric collar/ring) yielding predictable results.
Regarding claim 17, Pannek further teaches, wherein each of the plurality of scrapers (blades (30)) has a width greater than a thickness (Given Figures 3 and 4A-4B, which clearly illustrate the width and thickness of blades (30), it is clear that width is greater than thickness. Further, Col. 4, line 43-44, discloses, “Each pair of opposed blades 30 defines a plane…” Knowing that a plane indeed always has a width greater than a thickness).
Regarding claim 18, Pannek further teaches, wherein the expandable element (balloon (22)) comprises an inflatable balloon (Col. 5, line 10-19).
Regarding claim 19, Pannek does not explicitly teach, “wherein the plurality of scrapers comprise a shape memory material.” It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to form the plurality of scrapers from a shape memory material, since it has been held to within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. This’s further supported by the disclosure of Col. 4, line 59-63 of Panneks, “The cutting blades 30 in an unstressed shape form a first cutting diameter D1 as shown in FIG. 4A. The cutting blades 30 are formed however, to flex under pressure from the balloon 22 to an increased cutting diameter D2 which is shown in FIG. 4B.” In re Leshin.
Regarding claim 20, Pannek further teaches, wherein each of the plurality of scrapers (blades (30)) is longer than the expandable element (balloon (22)) (As seen in Figure 4B, blades (30) are clearly longer than balloon (22) to attach at the proximal end to end plate (46)).
Regarding claim 21, Pannek further teaches, wherein each of the plurality of scrapers (blades (30)) is adapted to pass into a space between the thrombus (plaque (10)) and the vessel (blood vessel (24)) without buckling (Figures 2A-2B and 4A-4B; The blades are advanced through the stenotic segment (arrow (27)) and then retracted/pulled back through the stenotic segment after balloon expansion (arrow (28)) while rotating, with the advancing cutter segment (36) and withdrawing cutter segment (40) specifically formed at angles “a” and “b” to facilitate reliable passage through the plaque and along the vessel wall (Col. 4, line 59-Col. 5, line 8; the blades maintain a structurally predictable configuration and reliable transition between compressed and expanded states under axial and rotational loads without collapsing or failing in their intended cutting and material-removal function).
Allowable Subject Matter
Claims 9-15 are allowed. The following is a statement of reasons for the indication of allowable subject matter: Independent claim 9 recites, an apparatus for engaging a thrombus in a vessel, comprising: a catheter including a distal end portion having a first expandable element, the catheter including a plurality of scrapers extending at least partially alongside the first expandable element, a proximal end portion of the plurality of scrapers extending at least partially alongside a second expandable element proximal of the distal end portion, the plurality of scrapers forming a cage lacking any expandable element therein and adapted to capture the thrombus, the first and second expandable elements adapted to cause the plurality of scrapers to compress around and capture the thrombus upon deflation of the first and second expandable elements for removal from the vessel; and at least one expandable collar attaching to at least one of the proximal end portion of the plurality of scrapers or the distal end portion of the plurality of scrapers, said at least one expandable collar at least partially surrounding at least one of the first expandable element or the second expandable element.
The claim is allowable because the specific combination of structural and functional limitations, when considered as a whole, is neither disclosed nor rendered obvious by the prior art. Piccagli (US 2017/0105758 A1) teaches, a scoring balloon catheter having proximal and distal control balloons with scoring elements attached at their ends. The scoring elements are placed under tension when the control balloons inflate and are forced outward by a central scoring balloon. While Piccagli has two control balloons and scoring elements spanning them, it does not teach or suggest: 1.) Scrapers forming an empty cage lacking any expandable element therein (Piccagli’s central scoring balloon occupies the interior space); 2.) The dual expandable elements being adapted to compress the scrapers around captured material upon deflation of both elements; and 3.) Use of expandable collars that attach to scraper ends and at least partially surround one of the expandable elements. Giasolli (US 2020/0155815 A1) teaches balloon cages comprising strips with wedge dissectors secured by rings/collars (some expandable/heat-shrink) for vessel preparation and serration. While Giasolli discloses rings/collar-like structures securing strips over a balloon, it does not disclose or suggest the full claimed combination: a catheter with two distinct expandable elements (distal first + proximal second), scrapers forming an empty internal cage between them, and the specific functional adaptation where deflation of both expandable elements actively compresses the cage around thrombus, aided by expandable collars surrounding the elements.
No other reference (or reasonable combination) of record teaches or suggests the integrated structure recited in claim 9 as a whole: dual expandable elements positioned with scrapers extending alongside each, forming an empty capture cage, with expandable collar(s) at the scraper ends that surround at least one expandable element, where the system is specifically adapted so that deflation of both expandable elements compresses the cage to capture and retain thrombus for removal. The prior art of record, taken individually or in combination, does not provide the requisite motivation or reasonable expectation of success to arrive at this precise arrangement for the purpose of atraumatic peripheral thrombus engagement and capture with reduced embolization risk.
Claims 10-15 are allowed by virtue of their dependency on claim 9.
Response to Arguments
Applicant's arguments filed on 09/17/2026 have been fully considered but they are not persuasive.
Rejection of Claims 1-3, 6-8, and 26 under 35 U.S.C. 102(a)(1) over Cassell:
Applicant argues that Cassell discloses only a passive distal-protection filter whose struts do not themselves dislodge or scrape a stenosis, that the phrase “adapted to” requires a structure specifically designed for the recited function rather than mere capability, and that Cassell therefore fails to disclose scrapers adapted to be inserted between the thrombus and the vessel (or to pass into that space without buckling). These arguments are not persuasive.
Under the broadest reasonable interpretation consistent with the specification (MPEP 2111), the claim language is not limited to Applicant’s preferred method of use. Apparatus claims cover what a device is, not merely what a device does (MPEP 2114; In re Schreiber, 128 F.3d 1473, 1478 (Fed. Cir. 1997)). Where a prior-art structure is capable of performing the recited function, the functional limitation is met. Cassell expressly discloses elongated struts attached distally, extending proximally alongside and beyond an expandable member, free at their proximal ends, formed of shape-memory material, and having a width greater than thickness. Upon expansion the free ends move radially outward to approximate the vessel diameter. The identical structure is capable of axial or rotational movement while expanded so that the free proximal ends enter any available interstitial space between stenosis/thrombus material and the vessel wall. The Office Action’s reliance on structural capability is therefore proper under MPEP 2114; the inherency standard of In re Oelrich is not implicated when the structure itself is expressly disclosed and is capable of the function.
Applicant’s characterization of Cassell as requiring a separate instrument to perform all fragmentation while the filter remains stationary is incomplete. Cassell contemplates use during thrombectomy and atherectomy procedures and discloses manipulation of the expanded assembly. Even if a separate dilatation device is also employed, the structural identity of the struts remains and satisfies the claim language.
The same structural disclosure anticipates new claim 26. With the expandable member expanded, the free proximal ends of the struts are spaced radially outward while the elongated intermediate portions of the ribbon-like struts extend substantially parallel to the longitudinal axis of the catheter between the distal attachment and the expanded proximal ends. The claim does not require perfect cylindrical parallelism of the entire length of each scraper.
Consequently, claims 1-3, 6-8, and 26 remain/are anticipated by Cassell.
Rejection of Claim 5 under 35 U.S.C. 103 over Cassell in view of Lucas:
Applicant has not traversed the combination of Cassell and Lucas. The previously articulated motivation - providing an additional distal occlusive element for enhanced containment of emboli - remains valid.
Claim 5 remains rejected.
Rejection of Claims 16-21 under 35 U.S.C. 103 over Pannek in view of Berrada:
Applicant argues that neither reference teaches an elastomeric collar, that the stated motivation is unsupported by the cited passages of Berrada, that substitution of an elastomeric collar would change Pannek’s principle of operation, that the design-choice rationale for claim 19 is insufficient, and that claim 21’s “without buckling” limitation is not met. These arguments are not persuasive.
Pannek discloses the basic structure of claim 16, including elongated blades attached distally and extending alongside an expandable element with proximal attachment and a longitudinal space therebetween. Berrada teaches collars/rings/bands for attaching the ends of flexible filter or scraper-like structures to catheter shafts and further teaches elastomeric polymers for flexible components of such vascular devices. Substituting an elastomeric collar for Pannek’s proximal attachment is a simple substitution of one known attachment means for another known equivalent means that yields the predictable result of a more compliant proximal connection (MPEP 2143(I)(B); KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007)). The modification does not render Pannek inoperable for its intended purpose; a person of ordinary skill would have recognized that a compliant proximal collar remains compatible with radial expansion and subsequent collapse of the blades.
The design-choice rationale for claim 19 is proper. Selection of a known material (shape-memory alloy) on the basis of its suitability for the intended flexure between compressed and expanded states is within the ordinary skill in the art (MPEP 2144.07; In re Leshin). No unexpected result is shown.
Claim 21’s functional language is likewise met by the structure of Pannek’s blades, which are disclosed as maintaining a predictable configuration under axial and rotational loads without collapsing. The same structural-capability analysis applied to claims 1 and 8 applies here (MPEP 2114).
Accordingly, claims 16–21 remain unpatentable over the combination of Pannek and Berrada.
Conclusion:
For the foregoing reasons, Applicant’s arguments are not persuasive. The rejections of claims 1-3, 5-8, 16-21, and 26 are maintained. Claims 9-15 remain allowed.
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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/O.N./Examiner, Art Unit 3771 /TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
