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 .
Response to Amendment
This Office Action is in response to the amendment filed September 22, 2025. Claims 1-5 and 17 are amended. Claims 7, 15-16, and 18-20 are canceled. Claims 8-11 stand withdrawn. Claims 1-6 and 12-14 and 17 are pending and addressed below.
Response to Arguments
Applicant’s amendments to the specification have overcome all of the previously presented specification objections cited in the Non-Final Office Action dated May 14, 2025.
Applicant’s amendments to the claims have overcome each and every claim objection and 35 U.S.C. 112(b) rejection previously set forth in the Non-Final Office Action dated May 14, 2025.
Applicant's arguments filed September 22, 2025have been fully considered but are not persuasive.
Applicant argues that the strut element “linear bodies 5” taught by Inoue (U.S. Patent No. 9492262) do not meet the claimed limitation of the struts in claim 1 because they do not operate in the same manner as recited in claim 1. Applicant supports this argument by citing to a section of Inoue in which the function of linear bodies 4 and 5 are not discussed as well as a section discussing the material of the linear bodies, alleging the taught material and structure could not perform the claimed function.
However, there are several instances in which Inoue discusses linear bodies 5 imposing a force on ring-shaped structure 31. The following passages are cited as such examples (emphasis added) (note: the first passage was cited by Examiner in the Non-Final Office Action dated May 14, 2025):
“(62) Further, in the spread state, the filter member 3 is kept by the linear bodies 4 and second linear bodies 5 in a posture where an opening face thereof is substantially orthogonal to the wire 22, i.e., substantially orthogonal to a blood flow direction. Note that the wire 22 in this embodiment is configured to slidably penetrate through the bottom part of the filter 32 and make a fore end thereof protrude from the filter 32 by a predetermined length. In addition, in order to make the wire 22 slidable, the wire 22 may be made to penetrate through a mesh in the bottom part of the filter 32, or an unillustrated tube into which the wire 22 is inserted may be provided and attached to the bottom part of the filter 32.”
“(69) Then, without moving the wire 22, the filter conveyance tube 12 is pulled out, and the filter member 3 is taken out of the fore end of the filter conveyance tube 12. In doing so, the ringlike elastic wire rod 31 is annularly spread in the blood vessel B, and the opening of the filter member 3 is also spread. On the other hand, a posture binding force caused by the linear bodies 4 and second linear bodies 5 acts on the ringlike elastic wire rod 31, and finally, as illustrated in FIG. 1, the filter 32 is annularly spread so as to make the opening thereof orthogonal to the blood flow direction, and the opening comes into close contact with an inner circumferential wall of the blood vessel B.”
Applying a force such that the open shape of structure 31 is maintained during use anticipates the claimed functional limitation “struts which place expanding or restraining force on the ring-shaped structure to maintain the opening in an expanded and open position,” as recited in claim 1. Therefore, Applicant’s arguments are unpersuasive.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “struts” in line 13 and again in line 19. It is clear from the specification that these recitations are referring to the same struts. Examiner suggests the second recitation in line 19 be “the struts” for consistency throughout the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inoue (U.S. Patent No. 9492262) in view of Fifer, et. al. (U.S. Publication No. 2019/0091005), hereinafter, “Fifer.”
Regarding claim 1, Inoue teaches an intravascular thrombus retraction device (100; Fig. 1) comprises wires (321; Fig. 2) that are compressible into a compact cylindrical form (see Fig. 5) within a first catheter (12; Fig. 5) and which are self-expandable (Col. 11, lines 27-32) into a wire mesh web (32; Fig. 1) with at least some parallel wires (see Fig. 2 showing wires 321 extending parallel in two directions forming openings) forming openings in the wire mesh (32) sufficient to allow fluid passage,
a base of the wire mesh web (32) connected to radially ring-shaped structure (31; Fig. 1) supporting and maintaining an opening in the base of the wire mesh (32) and forming a thrombus capture volume,
the ring-shaped structure (31) being compressible into the first catheter (see Fig. 5) and being self-expandable when free of compressive forces (Col. 11, lines 27-32) within the first catheter (12) to open up into an open, expanded ring-shaped structure (see Fig. 1), maintaining the opening in the base of the wire mesh (32),
the ring-shaped structure (31) attached to struts (5; Fig. 1) which place expanding or restraining force on the ring-shaped structure (31) to maintain the opening in an expanded and open position (Col. 10, lines 28-32),
multiple intermediate guide wires (4; Fig. 1) are connected to and spaced about the ring-shaped structure (31), the multiple intermediate guide wires (4) are connected to withdrawal guidewires (6; Fig. 1) extending into the first catheter (12; see Fig. 5),
wherein the ring-shaped structure (31) comprises or is attached to struts (5) which place expanding or restraining force on the ring-shaped structure (31) to maintain the opening in an expanded and open position allowing capture of a thrombus during a retraction step (Col. 10, lines 28-32 and Col. 11, lines 32-34).
However, Inoue does not explicitly teach openings in the wire mesh small enough to filter particles of at least 0.001mm.
Fifer teaches openings in a filter small enough to filter particles of at least 0.001mm (“filter holes 27 are between about 1 micron and 1000 microns.” Pp. [0076]).
Fifer is considered to be analogous to the claimed invention because it is in the same field of intraluminal filters. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inoue to incorporate the teachings of Fifer by providing an opening in the filter having a size of 1 micron. Doing so would be a simple substitution of one known filter size opening with another to provide the predictable results of providing a device for filtering blood with a reasonable expectation of success. (note – applicant claims the filter to filter particles “at least” the size of 0.001mm.”, i.e., particles larger than that 0.001mm; as currently worded, the filter must only be capable of filtering out a particle falling within the range of at least 0.001mm).
Regarding claim 5, Inoue further teaches the struts (5) which place expanding or restraining force on the ring-shaped structure (31) to maintain the opening in an expanded and open position extend from the first catheter (12) to the ring structure (31; see Fig. 5)
Claim(s) 2-3 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inoue in view of Fifer, and further in view of Consigny (U.S. Pub. No. 2014/0364896).
Regarding claim 2, Inoue further teaches the wire (321) comprises a non-thrombogenic metal (“on a surface of the resin thread 321, a special coating to which blood components are unlikely to attach is applied.” Col. 9, lines 36-39).
However, Inoue also does not explicitly disclose the wire having protrusions as claimed.
Consigny teaches wires (230; Fig. 2) in a wire mesh (110; Fig. 2) having protrusions (250; Fig. 2) having a height of less than 0.001mm, (“the roughened struts 230 may have an Arithmetic Mean Roughness (R.sub.a) in one or more of the following ranges: between about 0.8 .mu.m and 2 .mu.m,” pp. [0053]).
Consigny is considered to be analogous to the claimed invention because it is in the same field of thrombectomy devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inoue to incorporate the teachings of Consigny by providing protrusions along the wires of the wire mesh. Doing so would improve the wire’s ability to engage a thrombus and retain it in a capturing portion of the device as taught by Consigny (pp. [0086]-[0087]). This will increase the likelihood of removing all the thrombus from the body.
It is further noted that Inoue teaches the wires are made of resin (Col. 9, lines 36-37) which by extension means the protrusions would also be made of resin.
Regarding claim 3, Inoue further teaches at least some of the wires (321) in the wire mesh comprise the non-thrombogenic metal (Col. 9, lines 36-39), and
Consigny teaches the protrusions (250) extend inwardly into the thrombus capture volume (pp. [0055]),
at least some of the protrusions (250) having a height less than a distance between the at least some parallel wires (see Fig. 2); and
the protrusions (250) are elements (pp. 0052]) extending from surfaces of the wires and the protrusions are concave, convex, flat, or curvilinear (see flat sides of the protrusions in Fig. 2).
Regarding claim 17, Consigny further teaches the protrusions have convex, flat, or curvilinear tips (see Fig. 2 of Consigny; convex tips).
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inoue in view of Fifer, and further in view of Cooper, et. at. (U.S. Publication No. 2015/0265299) hereinafter, “Cooper.”
Regarding claim 4, Inoue further teaches two catheters, the first catheter (12; Figs. 1, 5) containing the wire mesh (32; Fig. 1) and ring-shaped structure (32; Fig. 1) in a compressed, non-expanded state (see Fig. 1), and a second catheter (1; Figs. 1, 5).
However, Inoue does not explicitly disclose the second catheter containing a compressed and expandable collection receptacle as claimed.
Cooper teaches a second catheter (60; Fig. 6) containing a compressed and expandable collection receptacle (18; Fig. 6), the collection receptacle (18) positioned within the second catheter (60) such that upon release from the catheter (60), the collection receptacle (18) expands to provide an opening in an opposed position with respect to the opening in the base of the wire mesh (see Fig. 7) of a released and expanded wire mesh (16; Fig. 6) and ring-shaped structure.
Cooper is considered to be analogous to the claimed invention because it is in the same field of thrombectomy devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inoue to incorporate the teachings of Cooper by providing a collection receptacle in the second catheter. Doing so would be combining prior art elements according to known methods to yield predictable results of providing a thrombectomy device with additional means for securing a thrombus with a reasonable expectation of success.
Regarding claims 6, Inoue further teaches the collection receptacle is attached to the struts (4) which place expanding or restraining force on the opening in the opposed position to maintain the opening in the opposed position in an expanded and open position (it is noted, the collection receptable would be attached to the struts by nature of the device being unitary).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inoue in view of Fifer, and further in view of Kucharczyk, et. al. (U.S. Patent No. 6626902) hereinafter, “Kucharczyk.”
Regarding claim 12, Inoue does not explicitly disclose a multi-lumen, multi-functional catheter system as claimed.
Kucharczyk teaches a multi-lumen, multi-functional catheter system (Col. 9, lines 10-56) comprising a plurality of axial lumens (Col. 9, lines 10-56), wherein at least one physiological measuring device is present within at least one lumen(Col. 9, lines 10-56), and wherein said physiological measuring device is in communication to a host computer (Col. 9, lines 10-56) configured to receive information to be evaluated by the host computer to provide procedures for various treatment plans (Col. 9, lines 10-56), wherein the host computer stores multiple treatment planning and therapy procedures to be executed by the individual patients (Col. 9, lines 10-56), and in response to data from the physiological measuring device the host computer provides an operator of the device specific procedures to actively modify an existing treatment plan for the treatment plans as therapy progresses (Col. 9, lines 10-56).
Kucharczyk is considered to be analogous to the claimed invention because it is in the same field of intraluminal catheters. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inoue to incorporate the teachings of Kucharczyk by providing a multi-lumen, multi-functional catheter system for use with a clot retraction catheter to provide procedures and treatment plans for deep vein thrombosis and/or pulmonary embolism specifically because that what the base reference Inoue is used for. Doing so would be combining prior art elements according to known methods to yield predictable results of providing a thrombectomy device with a means for obtaining and tracking patient data with a reasonable expectation of success.
Claim(s) 13 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Inoue in view of Fifer, and further in view of Panian (U.S. Publication No. 2019/0307985).
Regarding claim 13, Inoue further teaches an elongate flexible catheter body (1; Fig. 1) having a proximal end (not shown, but a catheter innately has a proximal end), a distal end (see Fig. 1) and a central lumen (see Fig. 1) extending longitudinally through the catheter body (1), and the protrusions comprise deposited metal, ceramic composite or polymeric elements (it is noted that the wires of Inoue are taught as being make of resin (Col. 9, lines 36-37) which by extension means the protrusions would also be made of resin).
However, Inoue does not explicitly disclose the catheter with a variable durometer outer jacket, wherein the catheter wall thickness ratio of the inner diameter to the outer diameter is 0.80 or higher, wherein the tensile strength of the catheter is higher than 2 lbs.
Panian teaches a catheter (800; Fig. 8) with a variable durometer outer jacket (pp. [0118]), wherein the catheter wall thickness ratio of the inner diameter to the outer diameter is 0.80 or higher (pp. [0060]), wherein the tensile strength of the catheter is higher than 2 lbs. (pp. [0129]).
Panian is considered to be analogous to the claimed invention because it is in the same field of thrombectomy devices. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inoue to incorporate the teachings of Panian by providing a catheter with a variable durometer outer jacket, a wall thickness ratio of the inner diameter to the outer diameter of 0.80 or higher, and a tensile strength of higher than 2 lbs. Doing so would be a simple substitution of one known catheter with another to provide the predictable results of providing catheter to deliver a thrombectomy filter to a target site with a reasonable expectation of success.
Regarding claim 14, Inoue further teaches an intravascular catheter (1; Fig. 1) having a distal end (see Fig. 1) and a proximal end (not shown, but a catheter innately has a proximal end), the catheter having an inner lumen (see Fig. 5; the inner lumen being the area within catheter 12) and an outer lumen (see Fig. 5; the outer lumen being the area around catheter 12).
However, Inoue does not explicitly disclose an aspiration pump and rotating motor as claimed.
Panian teaches an aspiration pump (1004; Fig. 4) attached to a proximal end (1003; Fig. 10) of a catheter (1001; Fig. 10), and a mechanically actuated positive displacement powered by a rotating motor (pp. [0135]), wherein the motor (pp. [0135]) rotates at a speed below 2000 RPM (pp. [0135]) when driving the aspiration pump and wherein the speed of the motor is cycled at a frequency below 10 Hz (pp. [0135]).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Inoue to incorporate the teachings of Panian by providing an aspiration pump at the end of a catheter. Doing so would be combining prior art elements according to known methods to yield predictable results of providing a thrombectomy device with aspiration which increases the device’s ability to secure a thrombus with a reasonable expectation of success.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL A. ICET whose telephone number is (571)272-0488. The examiner can normally be reached M-F: 8:00-5:00 CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL ICET/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771