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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 20, 2025 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Claims 1-15, 17-18, 21, 23-27, and 29-33 are pending in the application with claims 11-15, 17, 18, 21, and 23-27 being withdrawn from further consideration. The previous objections to the drawings are withdrawn in light of Applicant’s amendments to the claims. 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 November 20, 2025 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 Ulm, III (U.S. Patent Application Publication No. 20170172591; hereinafter “Ulm”).
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]).
Ulm, a reference in the thrombus extraction device field of endeavor, teaches providing a third region of a device with a second mouth (262; annotated Figs. 14A-14C below), wherein the second mouth is defined by four interconnected struts extending continuously through an entirety of the third region (annotated Fig. 14A below) to facilitate navigation of an extraction device through vasculature and facilitate entry of material into the extraction device (para. [0328]).
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Ulm further teaches the second mouth being larger than other cells of the extraction device (Figs. 14B, 14C) to allow material to enter into the extraction device (para. [0328]).
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 extending 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 Ulm, 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, Ulm discloses wherein the first mouth is radially offset from the second mouth (crowns (258) and respective openings (262) are radially offset relative to each other; para. [0328]).
Regarding claim 3, Marchand discloses wherein the pair of curved struts curve in opposite directions around the longitudinal axis (Fig. 5).
Regarding claim 4, Ulm discloses wherein the four interconnected struts include (a) a pair of upper curved struts (annotated Fig. 14A-14C below) that curve around a 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 (in Fig. 14C, the lower junction overlaps the upper junction in the perspective of Fig. 14C).
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Regarding claim 5, Ulm discloses wherein the lower and upper curved struts define (a) a first mouth portion opening (262A; Figs. 14B-14C) in a first direction generally orthogonal to the longitudinal axis and (b) a second mouth portion (262B; Figs. 14B-14C) opening in a second direction generally orthogonal to the longitudinal axis, and wherein the first and second mouth portions define the second mouth.
Regarding claim 6, Ulm teaches wherein the first direction is generally opposite to the second direction (Figs. 14B).
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 (Ulm Figs. 14B and 14C).
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, Ulm discloses wherein the second mouth is rotationally offset about the longitudinal axis relative to the first mouth (Fig. 14C).
Response to Arguments
Applicant's arguments filed November 20, 2025 have been fully considered but they are not persuasive.
On pages 10-11 of the Response, Applicant argues that Ulm does not disclose or suggest the second mouth being defined by “four interconnected struts extending continuously through an entirety of the third region,” as recited in claim 1 (Response pg. 10). This argument is not persuasive.
As explained above in this Office Action, Ulm teaches providing a third region of a device with a second mouth (262; annotated Figs. 14A-14C below) defined by four interconnected struts extending continuously through an entirety of the third region. Of particular note, Fig. 14A depicts branching, Y-shaped struts extending through an entirety of the third region.
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On pages 11-12 of the Response, Applicant argues that Ulm does not disclose or suggest the four interconnected curved struts intersecting each other at an upper or lower junction. This argument is not persuasive.
As explained above in this Office Action, Ulm teaches the four interconnected struts including a pair of upper curved struts intersecting at an upper junction positioned at a center of the second mouth and a pair of lower junction at the center of the positioning.
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Conclusion
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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/JONATHAN A HOLLM/Examiner, Art Unit 㝱