DETAILED ACTION
Claims 7-13 and 16-19 remain withdrawn. Claims 1 and 20 are amended. A complete action on the merits of pending claims 1-6, 14-15, and 20 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 07/24/2026 which are entered. With regards to the drawing, specification, and claim objections documented in the Non-Final Office Action sent on 04/28/2026, they are all overcome through Applicant’s amendments filed on 07/24/2026 and are withdrawn.
Claim Rejections - 35 USC § 102
Claim(s) 1-5, 14-15, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osborne (US 2010/0211087 A1).
Regarding claim 1, Osborne discloses, a mechanical thrombectomy system (Figure 4, delivery system (200); Paragraph [0040]), the system comprising:
an outer catheter (Figure 4, outer retention sheath (160); Paragraph [0041]) extending from a proximal end (Figures 5a-5c; Paragraph [0045] discloses in part, “A proximal end of the outer retention sheath 160 is fixedly attached to the handle 191”) to a distal end (Figure 4, distal end (162); Paragraph [0041]) and defining a first lumen extending therethrough (Figure 4 clearly shows a lumen of outer retention sheath (160) through which inner sheath (150) passes through);
an inner sheath (Figure 4, inner sheath (150); Paragraph [0040]) extending from a proximal end (Figures 5a-5c; Paragraph [0047] discloses in part, “Preferably, the proximal ends of the inner and outer sheaths 150, 160 terminate in luer lock type fittings 197.”) to a distal end (Figure 4, distal portion (152); Paragraph [0041]) and defining a second lumen extending therethrough (Figure 4 clearly shows a lumen of inner sheath (150) that receives thrombectomy device (100)), the inner sheath slidably disposed within the first lumen of the outer catheter (Figures 4 & 6; Paragraphs [0040]-[0044] and [0047]; The inner sheath (150) is slidably disposed within the lumen of the outer retention sheath (160));
an inner shaft (Figures 1, 4, & 7-8, torque shaft (140) & elongate torsion member (110); Paragraphs [0032]-[0039]) extending from a proximal end to a distal end region (Figures 4-5c; The torque shaft (140) is attached to the proximal end of the elongate torsion member (110) and extends proximally through the handle and inner sheath lumen (Paragraphs [0039] & [0050]-[0051])), the inner shaft slidably disposed within the second lumen of the inner sheath (Figures 4 and 7-8; Paragraph [0040]);
an expandable anchor mechanism (Figures 1-4 and 6-8, plurality of engagement members (120); Paragraph [0032]) coupled to the distal end region of the inner shaft (As seen in the figures, the plurality of engagement members (120) are coupled to the distal end region of the elongate torsion member (110)), the expandable anchor mechanism configured to move between a collapsed delivery configuration and an expanded configuration (Figures 1-4 and 6-8; Paragraphs [0032], [0036], and [0051]), wherein, in the expanded configuration, the expandable anchor mechanism (plurality of engagement members (120)) is configured to engage and anchor to a vessel wall (Figures 7-8; Paragraph [0051], explicitly discloses that engagement members (120) (Examiner notes there are clear drafting errors in paragraph [0051] of Osborne, where the engagement members (120) are assigned different reference numbers that correspond with other components disclosed earlier in Osborne’s disclosure) self-expand radially outward until they contact the vessel/cavity wall (10), specifically, “As the thrombectomy device 100 is advanced, the engagement members 120 automatically begin to flex in a radially outward direction… and assume the fully expanded configuration such that the engagement members 120 contact the vessel/cavity wall 10… Because the portions of the engagement members 120 that come in contact with the vessel/cavity wall 10 are atraumatic and present a smooth curve, the engagement members 120 can be safely expanded against the vessel/cavity wall 10 and rotatably or slidably advanced therealong… Moreover, by expanding the engagement members 120 against the vessel/cavity wall 10, gaps between the thrombectomy device and the vessel/cavity wall 10 are eliminated and any portions of the thrombus 20 that may break off during thrombectomy are more likely to be captured in the helical arrangement of engagement members 120.” Thus, a structure that expands into contact with and is advanced along the vessel wall while capturing thrombus is configured to “engage and anchor to a vessel wall.”); and
a handle (Figures 5a-5c, control handle (190) – handle (191), knob (196), & shaft (194)) coupled to the proximal end of the outer catheter (Paragraph [0045]).
Regarding claim 2, Osborne further discloses, wherein the anchor mechanism (plurality of engagement members (120)) comprises a torsion spring (The plurality of engagement members (120) couple to the distal end region of the elongate member (110). These engagement members (120) are formed from a continuous length of Nitinol wire that is “wound or otherwise incorporated into the braid structure” of the torsion member (110), creating a helically arranged structure that functions as a torsion spring: the members are torsionally biased to expand radially outward when unconstrained and are compressed radially inward by the inner sheath (Paragraphs [0035]-[0037] and [0040]). The torsion member (110) itself is explicitly a torsion cable, and the engagement members (120) are helically disposed around it, collectively forming the torsion-spring anchor mechanism).
Regarding claim 3, Osborne further discloses, wherein the torsion spring (engagement members (120) incorporated into the torsion member (110)) comprises a helically wound portion and one or more free ends (the torsion spring (engagement members (120) incorporated into the torsion member (110)) comprises a helically wound portion formed by the continuous Nitinol wire that is “wound … into the braid structure” and arranged in a helical pattern around the elongate torsion member (110) (Paragraphs [0035] & [0037]). The radially outward portions of each engagement member (120) (the smooth, arcing loop segments) function as the free ends that extend radially from the helically wound portion and are capable of radial deflection (Figures 1-3; Paragraph [0035]). The helical winding of the wire and the spaced helical arrangement of the loops provide the helically wound portion with free ends that pivot/rotate radially).
Regarding claim 4, Osborne further discloses, wherein the helically wound portion biases the one or more free ends into an expanded configuration (The helically wound Nitinol wire portion (incorporated into the braid of torsion member (110)) biases the free-end portions of the engagement members (120) into the expanded configuration. The pseudoelastic Nitinol wire is formed so that, when unconstrained by the inner sheath (150), the helically wound structure and the material’s spring-like properties cause the free ends (the radial loops) to move radially outward into the expanded state in which they contact the vessel wall (Paragraphs [0036], [0040], and [0051]). The helical arrangement and winding inherently store and release biasing energy to drive expansion).
Regarding claim 5, Osborne further discloses, wherein a biasing force is configured to radially deflect the one or more free ends radially inwards (The biasing force of the helically wound Nitinol torsion-spring structure (engagement members (120) incorporated into the torsion member (110)) is configured to radially deflect the free ends. When the inner sheath (150) is disposed over the anchor (engagement members (120)), the sheath applies a radial compressive force that deflects the free-end loops radially inwards into the collapsed configuration; the underlying torsional bias of the helically wound wire resists this deflection and returns the free ends outward upon release (Paragraphs [0036] & [0040]). The Nitinol pseudoelasticity combined with the helical winding provides the biasing force that acts on the free ends to allow controlled inward radial deflection under sheath constraint).
Regarding claim 14, Osborne further discloses, wherein when the inner sheath (inner sheath (150)) is disposed over the anchor mechanism (plurality of engagement members (120)), the anchor mechanism is biased into the collapsed configuration and when the inner sheath is proximally retracted relative to the anchor mechanism, the anchor mechanism expands into the expanded configuration (When the inner sheath (150) is disposed over the engagement members (120), they are flexed/folded down into the collapsed state. Proximal retraction of the inner sheath (150) (or distal advancement of the device out of the sheath) allows the Nitinol engagement members (120) to self-expand radially outward (Figures 6-7; Paragraphs [0040] and [0050]-[0051])).
Regarding claim 15, Osborne further discloses, wherein when the anchor mechanism (plurality of engagement members (120)) is in the expanded configuration, distal advancement of the inner sheath (inner sheath (150)) biases the anchor mechanism to the collapsed configuration (After expansion, the thrombectomy device (100) (with expanded engagement members (120)) is withdrawn back into the inner sheath (150); distal advancement of the inner sheath (150) (or relative proximal movement of the device) forces the engagement members to gradually flex back to the collapsed from inside the sheath. The expandable distal portion (152) (funnel shape) aids this resheathing (Figure 8; Paragraph [0053])).
Regarding claim 20, Osborne discloses, a method for removing a clot (Figures 6-8, thrombus (20); Paragraphs [0017] and [0048]), the method comprising:
advancing a mechanical thrombectomy system (Figure 4, delivery system (200); Paragraph [0040]) through a vasculature to a target location (Paragraph [0048]), the mechanical thrombectomy system comprising:
an outer catheter (Figure 4, outer retention sheath (160); Paragraph [0041]) extending from a proximal end (Figures 5a-5c; Paragraph [0045] discloses in part, “A proximal end of the outer retention sheath 160 is fixedly attached to the handle 191”) to a distal end (Figure 4, distal end (162); Paragraph [0041]) and defining a first lumen extending therethrough (Figure 4 clearly shows a lumen of outer retention sheath (160) through which inner sheath (150) passes through);
an inner sheath (Figure 4, inner sheath (150); Paragraph [0040]) extending from a proximal end (Figures 5a-5c; Paragraph [0047] discloses in part, “Preferably, the proximal ends of the inner and outer sheaths 150, 160 terminate in luer lock type fittings 197.”) to a distal end (Figure 4, distal portion (152); Paragraph [0041]) and defining a second lumen extending therethrough (Figure 4 clearly shows a lumen of inner sheath (150) that receives thrombectomy device (100)), the inner sheath slidably disposed within the first lumen of the outer catheter (Figures 4 & 6; Paragraphs [0040]-[0044] and [0047]; The inner sheath (150) is slidably disposed within the lumen of the outer retention sheath (160));
an inner shaft (Figures 1, 4, & 7-8, torque shaft (140) & elongate torsion member (110); Paragraphs [0032]-[0039]) extending from a proximal end to a distal end region (Figures 4-5c; The torque shaft (140) is attached to the proximal end of the elongate torsion member (110) and extends proximally through the handle and inner sheath lumen (Paragraphs [0039] & [0050]-[0051])), the inner shaft slidably disposed within the second lumen of the inner sheath (Figures 4 and 7-8; Paragraph [0040]);
an expandable anchor mechanism (Figures 1-4 and 6-8, plurality of engagement members (120); Paragraph [0032]) coupled to the distal end region of the inner shaft (As seen in the figures, the plurality of engagement members (120) are coupled to the distal end region of the elongate torsion member (110)), the expandable anchor mechanism configured to move between a collapsed delivery configuration and an expanded configuration (Figures 1-4 and 6-8; Paragraphs [0032], [0036], and [0051]), wherein, in the expanded configuration, the expandable anchor mechanism (plurality of engagement members (120)) is configured to engage and anchor to a vessel wall (Figures 7-8; Paragraph [0051], explicitly discloses that engagement members (120) (Examiner notes there are clear drafting errors in paragraph [0051] of Osborne, where the engagement members (120) are assigned different reference numbers that correspond with other components disclosed earlier in Osborne’s disclosure) self-expand radially outward until they contact the vessel/cavity wall (10), specifically, “As the thrombectomy device 100 is advanced, the engagement members 120 automatically begin to flex in a radially outward direction… and assume the fully expanded configuration such that the engagement members 120 contact the vessel/cavity wall 10… Because the portions of the engagement members 120 that come in contact with the vessel/cavity wall 10 are atraumatic and present a smooth curve, the engagement members 120 can be safely expanded against the vessel/cavity wall 10 and rotatably or slidably advanced therealong… Moreover, by expanding the engagement members 120 against the vessel/cavity wall 10, gaps between the thrombectomy device and the vessel/cavity wall 10 are eliminated and any portions of the thrombus 20 that may break off during thrombectomy are more likely to be captured in the helical arrangement of engagement members 120.” Thus, a structure that expands into contact with and is advanced along the vessel wall while capturing thrombus is configured to “engage and anchor to a vessel wall.”);
distally advancing the inner sheath and the inner shaft through a clot in the vasculature (Paragraph [0054] discloses that in the alternative embodiment of deploying delivery system (200), the entire delivery system (200) (including outer retention sheath (160), inner sheath (150), and restrained inner shaft/anchor) is “partially inserted into the thrombus (20)” with the anchor still collapsed, after which the anchor is deployed. This places the inner sheath and inner shaft at least partially into the clot);
proximally retracting the inner sheath to expand the anchor mechanism (After positioning, the thrombectomy device (inner shaft + engagement members (120)) is advanced distally out of the inner sheath (150), allowing the Nitinol engagement members (120) to self-expand radially outward into contact with the vessel wall (Figures 6-7; Paragraph [0050]-[0051]). Because the system is coaxial and slidable, proximally retracting the inner sheath (150) while holding the inner shat stationary produces the identical result: release of radial compression on the anchor, causing expansion from collapsed to expanded configuration. The disclosure of Osborne expressly recognizes relative sliding between the inner sheath and the inner shaft (Paragraphs [0040] & [0050]). The anchor expands after the device reaches the clot are. This step is performed);
distally advancing the outer catheter through the clot (Again, Paragraph [0054] discloses that in the alternative embodiment of deploying delivery system (200), the entire delivery system (200) (including outer retention sheath (160), inner sheath (150), and restrained inner shaft/anchor) is “partially inserted into the thrombus (20)” with the anchor still collapsed, after which the anchor is deployed. This places the outer catheter at least partially through the clot); and
distally advancing the inner sheath to recapture the anchor mechanism (After the thrombus is captured, the thrombectomy device (inner shaft + expanded engagement member (120)) is withdrawn back into the inner sheath (150), which forces the engagement members to gradually flex/collapse back to the delivery configuration. This is accomplished by distal advancement of the inner sheath (150) relative to the inner shaft (or proximal withdrawal of the device into the sheath) (Figure 8; Paragraph [0053]). The funnel-shaped expandable distal portion (152) of the inner sheath aids gradual resheathing and capture of any dislodged fragments).
Claim Rejections - 35 USC § 103
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osborne, in view of Ogle (US 2017/0056061 A1).
Regarding claim 6, Osborne teaches, the one or more free ends (the radial loops of engagement members (120)). Osborne further teaches, that the wire forming engagement members (120) may be doped with platinum, or other radiopaque elements (Paragraph [0038]).
Osborne fails to teach, further comprising a polymer jacket disposed over at least a portion of the one or more free ends.
Ogle discloses, treatment systems and component devices designed for the engagement and removal of thrombus. Ogle teaches, a stent retriever (Figures 16-19; Paragraphs [0096]-[0103]) comprising an open metal frame (255) that extends into a generally cylindrical shape and a polymer cover (259) extending around and adhered to the exterior of the open metal frame (Paragraphs [0005], [0070], & [0099]); the polymer cover is applied over the metal frame/struts (the radially outward portions that engage the vessel wall) to provide additional cushion against the vessel wall and soften the metal elements to reduce risk of damage to the vessel wall; suitable polymer covers include thin sheets of expanded polytetrafluoroethylene (ePTFE), electrospun PTFE web (e.g., BioWeb™ coating), or other biocompatible polymers, adhered via adhesive, heat bonding, or lamination (thickness about 2-100 microns, preferably 4-50 microns).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Osborne’s engagement members (120) (anchor mechanism) by adding the polymer cover/jacket taught in Ogle over at least a portion of the free-end/loop portions, as both references and the claimed invention are directed to treatment systems and component devices designed for the engagement and removal of thrombus. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Osborne’s engagement members (120) (anchor mechanism) by adding the polymer cover/jacket taught in Ogle over at least a portion of the free-end/loop portions, as such a modification would have been predictable, namely, provide softer vessel contact without loss of anchoring or clot engagement.
Response to Arguments
Applicant's arguments filed on 07/24/2026 with respect to the rejection of claims 1-5, 14-15, and 20 under 35 U.S.C. 102(a)(1) as anticipated by Osborne (US 2010/0211087 A1) and the rejection of claim 6 under 35 U.S.C. 103 as unpatentable over Osborne, in view of Ogle (US 2017/0056061 A1) have been fully considered but they are not persuasive.
With regards to Independent Claims 1 and 20:
Applicant argues that Osborne fails to disclose an expandable anchor mechanism configured, in the expanded configuration, to engage and anchor to a vessel wall, contending that mere wall contact is not anchoring and that Osborne’s engagement members function as a movable thrombectomy element that is rotated and advanced through the thrombus (thereby allegedly teaching away from anchoring).
This argument is unpersuasive. Anticipation under 35 U.S.C. 102 requires that the identical invention be shown in as complete detail as is contained in the claim (MPEP 2131; Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236 (Fed. Cir. 1989)). Functional claim language is anticipated by prior art that is capable of performing the recited function (MPEP 2114).
Osborne expressly discloses that the plurality of engagement members (120) expand radially outward into contact with the vessel/cavity wall (10) (Figures 7-8; Paragraph [0051]). The members present atraumatic surfaces that engage the wall so that the device can be rotatably or slidably advanced along the wall while capturing thrombus, eliminating gaps between the device and the wall (Paragraph [0051]). Expansion into firm contact with the wall while the device is held or advanced relative to the clot provides the structural and functional capability of engaging and anchoring to the vessel wall as claimed. The claim does not require any particular degree, duration, or mechanism of anchoring beyond the recited configuration, nor does it preclude subsequent distal advancement or rotation of the shaft after expansion.
Applicant’s characterization that Osborne “teaches away” is inapposite to a 102 rejection. Teaching away is relevant primarily to obviousness under 103 (MPEP 2145). Because Osborne discloses a structure capable of the recited function in the same arrangement of elements, the claims are anticipated. Therefore the same analysis applies, to claim 20.
The amendments adding the “engage and anchor to a vessel wall” language therefore do not patentably distinguish the claims over Osborne. The rejections of claims 1 and 20, and the claims depending therefrom under 102(a)(1) are maintained and updated as above.
With regards to Dependent Claim 2:
Applicant argues that Osborne does not disclose an anchor mechanism comprising a torsion spring, asserting that the engagement members (120) are discrete loop structures arranged helically rather than a torsion spring having a helically wound portion, and that the Office improperly combined elements of the torsion member and the engagement members.
his argument is not persuasive. As set forth in the rejection, Osborne discloses that the engagement members (120) are formed from a continuous length of Nitinol wire that is “wound or otherwise incorporated into the braid structure” of the elongate torsion member (110), creating a helically arranged structure (Paragraphs [0035]-[0037]). The Nitinol wire is in the pseudoelastic state at body temperature and is torsionally biased to expand radially outward when unconstrained (and compressed radially inward by the inner sheath)) (Paragraphs [0036] and [0040]). This continuous, helically arranged, resilient wire structure that stores and releases energy to bias the members radially outward meets the broadest reasonable interpretation of a “torsion spring.” The claim does not require a classical discrete coiled spring, any particular number or localization of coils, or exclusion of incorporation into a supporting shaft. The torsion member (110) being a torsion cable further supports the collective structure functioning as the claimed torsion-spring anchor mechanism. No improper hindsight is involved; the disclosure is explicit. The rejection of claim 2 under 35 U.S.C. 102(a)(1) is maintained.
With regards to Dependent Claim 3:
Applicant argues that Osborne does not disclose a torsion spring comprising a helically wound portion and one or more free ends, contending that the engagement members are closed loops and that radially outward portions of the loops are not free ends.
This argument is not persuasive. As set forth in the rejection, the continuous Nitinol wire that is wound into the braid structure and arranged in a helical pattern around the elongate torsion member (110) constitutes the helically wound portion (Paragraphs [0035] and [0037]). The radially outward portions of each engagement member (120) (the smooth, arcing loop segments) function as the free ends that extend radially from the helically wound portion and are capable of radial deflection between the compressed and expanded states (Figures 1-3; Paragraph [0035]). Under the broadest reasonable interpretation (BRI) consistent with the specification, “free ends” encompasses these portion that are free to flex and pivot radially; the claim does not require the free ends to be terminal, open, or non-looped. The rejection of claim 3 35 U.S.C. 102(a)(1) is maintained.
With regards to Dependent Claims 4-5 and 14-15:
Because the independent claim 1 remains anticipated, and Applicant has not separately argued patentability of these claims beyond their dependence, the rejections under 35 U.S.C. 102(a)(1) are maintained for the reasons of record and those set forth above.
With regards to the 35 U.S.C. 103 rejection of Claim 6:
Applicant traverses the rejection of claim 6 over Osborne in view of Ogle on the grounds that Osborne fails to teach every element of claim 1 and that there is no motivation to combine.
This argument is unpersuasive. As set forth above, Osborne anticipates claim 1. Ogle is relied upon solely for the additional limitation of claim 6 (polymer jacket over at least a portion of the free ends). One of ordinary skill in the art would have been motivated to provide a polymer covering on the engagement members of Osborne for the conventional reasons of atraumaticity, lubricity, or biocompatibility, as taught by Ogle, with a reasonable expectation of success. The combination is therefore proper under 35 U.S.C. 103 (MPEP 2143). The rejection of claim 6 is maintained.
Conclusion:
Applicant’s arguments have been considered but are not persuasive for the reasons set forth above. The rejections of record stand. See updated rejections above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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
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