/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771 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 .
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 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.
Response to Amendment
The Response filed April 13, 2026 has been entered. Claims 1-15, 17-18, 21, 23-27, and 29-33 are pending in the application with claims 11-15, 17-18, 21, and 23-27 being withdrawn from further consideration. Response to applicant's arguments can be found at the end of this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 13, 2026 was filed after the mailing date of the Non-final Office Action on January 13, 2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-10 and 29-33 are rejected under 35 U.S.C. 103 as being unpatentable over Marchand et al. (U.S. Patent Application Publication No. 20170112513; hereinafter “Marchand”) in view of Brady et al. (U.S. Patent No. 8852205; hereinafter “Brady”).
Regarding claim 1, Marchand discloses a coring element for coring a vascular thrombus within a blood vessel of a patient (Figs. 2-5; paras. [0095]-[0109]), the coring element comprising:
a unitary structure (400; annotated Figs. 4 and 5 below; para. [0103]) extending along a longitudinal axis, wherein the unitary structure comprises
a first region (406) adjacent to a proximal portion of the unitary structure, wherein the first region includes a pair of curved struts (410-A, 410-B) extending from a common proximal junction to a distal junction to define a first mouth (414) configured to core the vascular thrombus as the unitary structure is retracted proximally against the vascular thrombus (para. [0108]), wherein the proximal junction is radially offset from the longitudinal axis (Fig. 4);
a second region distal of the first region, wherein the second region is generally tubular and includes a first plurality of interconnected struts (402) forming first cells;
a third region distal of the second region; and
a fourth region distal of the third region, wherein the fourth region is generally tubular and includes a second plurality of interconnected struts forming second cells, and wherein the first mouth is larger than each of the first cells and the second cells (Fig. 4); and
a connection feature (415) coupled to the proximal junction, wherein the connection feature is configured to be coupled to a shaft (para. [0111]) for proximally retracting the unitary structure against the vascular thrombus (para. [0105]).
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The device of Marchand is not explicitly disclosed with the third region including a second mouth. However, Marchand teaches providing the coring device with an additional mouth (420) to receive tissue (para. [0105]) and configuring a mouth to core a vascular thrombus (para. [0108]).
Brady, a reference in the thrombus extraction device field of endeavor, teaches configuring a structure to include a third region with a second mouth (inlet mouths (3405); Fig. 60a) defined by four interconnected struts, wherein each of the four interconnected struts extends continuously through an entirety of the third region(annotated Fig. 60a below); such that the second mouth is larger than each of first cells in a second region of the structure and second cells in a fourth region of the structure (Fig. 60a) in order to facilitate urging a clot into the structure for removal (col. 70, ll. 38-41).
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to provide the third region with a second mouth, wherein the second mouth is defined by four interconnected struts, and wherein each of the four interconnected struts extends continuously through an entirety of the third region, wherein the second mouth is larger than each of the first cells and the second cells, in view of Brady, in order to provide additional openings that receive thrombotic material to facilitate collecting thrombotic material within the coring device.
Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the second mouth, to core the vascular thrombosis, in view of Marchand, in order to allow cutting material for easier entry into the coring device to facilitate capture and removal of thrombus material.
Regarding claim 2, Brady discloses wherein the first mouth is radially offset from the second mouth (e.g., the mouth defined by arms (3413) opens at a first, non-perpendicular radial angle relative to the longitudinal axis of the device while the mouths (3405) open at a perpendicular radial angle relative to the longitudinal axis of the device, thus the first and second mouths are radially offset from each other; Fig. 60a).
Regarding claim 3, Marchand discloses wherein the pair of curved struts curve in opposite directions around the longitudinal axis (Fig. 5).
Regarding claim 4, Brady discloses wherein the four interconnected struts include (a) a pair of upper curved struts that curve around the longitudinal axis and intersect each other at an upper junction positioned at a center of the second mouth and (b) a pair of lower curved struts that curve around the longitudinal axis and intersect each other at a lower junction positioned at the center of the second mouth (annotated Fig. 60a below).
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Regarding claim 5, Brady discloses wherein the lower and upper curved struts define (a) a first mouth portion opening in a first direction generally orthogonal to the longitudinal axis and (b) a second mouth portion opening in a second direction generally orthogonal to the longitudinal axis, and wherein the first and second mouth portions define the second mouth (annotated Fig. 60a below).
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Regarding claim 6, Brady discloses wherein the first direction is generally opposite to the second direction (Fig. 60a).
Regarding claim 7, Marchand discloses wherein the coring element is expandable from a compressed delivery configuration to an expanded deployed configuration (Figs. 23-F – 23-H; para. [0345]).
Regarding claim 8, Marchand discloses wherein the coring element is configured to self-expand (paras. [0101]-[0102]).
Regarding claim 9, Marchand discloses wherein the coring element is made from a shape memory material (paras. [0101]-[0102]).
Regarding claim 10, Marchand discloses wherein the fourth region of the unitary structure is configured to be connected to a braided filament mesh structure (Figs. 7-11; paras. [0115]-[0128]).
Regarding claim 29, the modified device discloses wherein the first mouth comprises a closed cell defined by the pair of curved struts (Marchand Fig. 5), and wherein the second mouth comprises a closed cell defined by the four interconnected struts (Brady Fig. 60a).
Regarding claim 30, Marchand discloses wherein the first mouth extends substantially along a first plane, and wherein the first plane is angled at a non-parallel angle relative to the longitudinal axis (Figs. 4 and 5).
Regarding claim 31, the modified device discloses the invention substantially as claimed, except for the upper curved struts and the lower curved struts including leading edges configured to core a vascular thrombus.
However, Marchand teaches configuring leading edges of struts to include leading edges configured to core a vascular thrombus (para. [0108]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to configure the upper curved struts and the lower curved struts to include leading edges configured to core a vascular thrombus, in view of Marchand, in order to allow the upper curved struts and lower curved struts to cut thrombus material for easier entry into the coring device to facilitate capture and removal of the material.
Regarding claim 32, Marchand discloses wherein the coring element is configured to flex at the third region (third region flexes between a compressed configuration (Fig. 32-G) and an expanded configuration(Fig. 23-H)).
Regarding claim 33, Brady discloses wherein the second mouth is rotationally offset about the longitudinal axis relative to the first mouth (e.g., the mouth defined by arms (3413) opens at a first, non-perpendicular radial angle relative to the longitudinal axis of the device while the mouths (3405) open at a perpendicular radial angle relative to the longitudinal axis of the device, thus the first and second mouths are radially offset from each other; Fig. 60a).
Response to Arguments
Applicant’s arguments with respect to claims 1-10 and 29-33 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.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan A Hollm whose telephone number is (703)756-1514. The examiner can normally be reached Mon - Fri 8:30-5:30.
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/J.A.H./Jonathan HollmExaminer, Art Unit 3771
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