DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/18/25 has been entered.
Response to Arguments
Applicant's arguments filed 11/18/25 have been fully considered but they are not persuasive. Examiner cannot find support for the amendment in the Applicant’s Specification nor is it mentioned in the Arguments. Even so, Fojtik discloses the surface disruption facilitates the direction of the suction—not that it does the aspiration (see par. 46).
Furthermore, Applicant argues it would not have been obvious to add Trosper’s closed tip to Fojtik as it would prevent Fojtik’s reliance on the guide wire. However, Trosper does teach the use of the atraumatic tip with a guide wire (see par. 56). In fact, Trosper’s guide wire also runs through the length of the catheter right up to the atraumatic tip (see Fig. 5 and 6a; par. 59). Therefore, modifying Fojtik’s distal end with Trosper’s closed tip would not change Fojtik’s operation as the guide wire would still be able to provide the support and maneuverability needed for proper placement (see Trosper; par. 56) while still preventing any tissue damage (see Trosper; par. 49).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The amended limitation of “the surface disruption is configured not to aspirate” in line 14 of Claim 1 is not supported by the as-filed specification.
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.
Claim(s) 1, 3-12, 15, 17-19, and 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik (PG Pub. 2022/0039814) in view of Trosper et al. (PG Pub. 2020/0170666).
Regarding Claim 1, Fojtik discloses a medical system comprising: an aspiration catheter (see catheter 40) defining a catheter lumen (see par. 32); and an inner member (see disruptor 12) configured to be received in the catheter lumen and extend distally outward from a distal opening of the catheter (see par. 45), wherein the inner member comprises: an elongated support member (see elongated element 20) configured to move axially within the catheter lumen (see par. 32), the elongated support member defining a longitudinal axis (see Fig. 1); and a distal member (see bulbous tip 30) at a distal portion of the elongated support member (see Fig. 1), wherein the distal member defines a larger cross-sectional dimension than the elongated support member in a direction orthogonal to the longitudinal axis (see Fig. 1-2), wherein a proximal-facing surface of the distal member defines a proximal taper (see par. 5, 42, and 49), and wherein the distal member defines a surface disruption (see slant 37) configured to aid disruption of a thrombus (see par. 46), wherein the surface disruption is configured not to aspirate (see par. 46). Fojtik discloses the surface disruption facilitates the direction of the suction—not that it does the aspiration. Fojtik does not disclose that the entire distal end of the distal member defines a closed surface. Trosper discloses a similar aspiration device wherein the distal member defines a surface disruption to aid in the disruption of a thrombus (see aperture 202 and thrombus 201; par. 50, Fig. 2), wherein the entirety of a distal end of the distal member defines a closed surface (see atraumatic tip 101/207/307; par. 19, 49, 56). It would have been obvious to one of ordinary skill in the art at the time of the invention to include a tip with a closed surface because Trosper teaches it is useful in “rapid exchange” introduction (see par. 75) while maintaining structure and flexibility to enter passageways of the body without causing damage to the patient (see par. 56).
Regarding Claim 3, Fojtik discloses wherein the distal member comprises a bulb including an atraumatic convex distal surface profile (see embodiment where maximum outer diameter is at the distal portion; par. 6).
Regarding Claim 4, Fojtik discloses wherein the inner member terminates at a distal end (see distal end 26) of the distal member (see par. 35 and Fig. 1).
Regarding Claim 5, Fojtik discloses wherein the proximal taper of the distal member has an angle with reference to the longitudinal axis of 10 degrees to 30 degrees (see par. 42), wherein the proximal taper of the distal member comprises:
a first taper portion having a first taper angle relative to the longitudinal axis; and
a second taper portion proximal to the first taper portion, wherein the second taper portion has a second taper angle relative to the longitudinal axis, the second taper angle being less than the first taper angle (see par. 5 and 42; Fig. 9).
Regarding Claim 6, Fojtik discloses wherein the surface disruption comprises at least one of a notch or a protrusion (see par. 9 and 47) and wherein the surface disruption extends along a circumference of the distal member (see Fig. 13B). Slant 37 extends along a circumference, or boundary, of bulbous tip 30. The claim, as written, does not require “entire” or “whole” circumference.
Regarding Claim 7, Fojtik discloses wherein the elongated support member comprises a retention member configured to aid attachment between the elongated support member and the distal member (see par. 38).
Regarding Claim 8, Fojtik discloses wherein the retention member is configured to increase a surface area of a part of the elongated support member that attaches to the distal member. The examiner considers slots, flanges, and protrusions would increase surface area because they are extending in space either outwardly or inwardly.
Regarding Claim 9, Fojtik discloses wherein the retention member comprises at least one of a coil, a coil anchor, a profiled wire, helix, a spiral, a spade-shape in cross-section, a slotted wire, or a T-weld (see par. 54).
Regarding Claim 10, Fojtik discloses wherein the distal member comprises a polymer configured to surround and attach to the retention member (see par. 33 and 55-56).
Regarding Claim 11, the examiner considers a coextrusion or molding together of the distal member and elongated support member using a polymer layer would necessarily increase adhesion because both processes include combining or joining together.
Regarding Claim 12, Fojtik discloses wherein the inner member is configured to travel a fixed distance out of the distal opening of the aspiration catheter (see par. 65-66). The examiner considers that if element 20 is connected to actuator 62 and actuator 62 is fixed relative to a length of the catheter, then element 20 is also configured to travel a fixed distance out of the distal opening of the catheter.
Regarding Claim 15, Fojtik discloses wherein the proximal-facing surface of the distal member defines one or more openings (see opening 38) configured to deliver a fluid into vasculature of a patient to dilute or displace a volume of blood aspirated from the vasculature of the patient and through the catheter lumen (see par. 78-79).
Regarding Claim 17, see rejection of similarly worded Claim 1 above. Fojtik further discloses deploying the distal member to contact a thrombus and moving it proximally or distally through the thrombus (see par. 15 and 78).
Regarding Claim 18, Fojtik discloses causing a suction source to apply a suction force to the catheter lumen to aspirate at least part of the thrombus through the catheter lumen (see par. 15, 43, and 46).
Regarding Claim 19, Fojtik discloses wherein moving the distal member at least one of proximally or distally through the thrombus comprises moving the distal member while the suction force is being applied to the catheter lumen (see par. 15).
Regarding Claim 21, see rejection of similarly worded Claim 1 above.
Regarding Claim 22, see rejection of similarly worded Claim 9 above.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik (PG Pub. 2022/0039814) and Trosper et al. (PG Pub. 2020/0170666), in view of Nguyen et al. (PG Pub. 2020/0390458).
Regarding Claim 2, Fojtik discloses the distal tip (see tip 46) of the catheter (see catheter 40) defines a taper (see par. 49 and Fig. 7B), but does not disclose the elongate support member defining a distal taper. Nguyen discloses a similar aspiration device wherein the elongated support member (elongated member 120) defines a distal taper (see par. 590). It would have been obvious to one of ordinary skill in the art at the time of the invention to narrow the elongated member in a distal direction to provide flexibility and advancement through tortuous passages in the body (see par. 589).
Claim(s) 13-14, 16, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fojtik (PG Pub. 2022/0039814) and Trosper et al. (PG Pub. 2020/0170666), in view of Chou et al. (PG Pub. 2022/0111177).
Regarding Claim 13, Fojtik does not disclose the inner member is biased at an angle. Chou discloses a similar aspiration system wherein the inner member is biased at an angle greater than or equal to 10 degrees and less than or equal to 30 degrees relative to longitudinal axis of a proximal portion of the aspiration catheter (see par. 132). It would have been obvious to one of ordinary skill in the art at the time of the invention to bias the inner member at an optimal angle relative to the longitudinal axis of the catheter because Chou teaches it helps the catheter system pass through tortuous loops while maintaining the natural curves of the anatomy therein decreasing the risk of vessel straightening (see par. 78).
Regarding Claim 14, Chou further discloses providing a tactile response along the elongated support member when the proximal taper engages with the aspiration catheter (see par. 171). It would have been obvious to one of ordinary skill in the art at the time of the invention to provide a tactile response because Chou teaches it helps inform the user of a stopping point and to prevent buckling from advancing pressure (see par. 171).
Regarding Claim 16, Fojtik generally discloses an aspiration pump (see par. 60), but does not elaborate on the other back-end components of the aspiration system. Chou discloses an aspiration pump fluidically coupled to the catheter lumen (see par. 86-88);
a fluid source fluidically coupled to the support member lumen and configured to store the fluid (see syringe; par. 86);
a valve (see RHV 434) fluidically coupled between the aspiration pump and the distal opening of the aspiration catheter (see par. 86);
control circuitry (see flow controller; par. 86) configured to control an opening and a closing of the valve to synchronize an aspiration force from the aspiration pump with a supply of the fluid from the fluid source; and an actuator switch coupled to the valve (see flow control switch par. 87), wherein the control circuitry is configured to control the opening and the closing of the valve via the actuator switch. It would have been obvious to one of ordinary skill in the art at the time of the invention to include these components because Chou teaches it can help manage flow rate to optimize emboli aspiration while limiting the amount of blood aspirated (see par. 88).
Regarding Claim 20, Chou further discloses distally moving the distal member, based on determining that the position of the distal member is proximate the distal end of the catheter, to increase a suction force applied to the thrombus via the catheter lumen (see par. 71). It would have been obvious to one of ordinary skill in the art at the time of the invention to push the distal member to increase suction force because Chou teaches the benefit of catheter advancement to safely find the true proximal face of the embolus for optimized suction (see par. 71 and 159).
Conclusion
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/N.P/Examiner, Art Unit 3792
/UNSU JUNG/Supervisory Patent Examiner, Art Unit 3792