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 .
Claim Objections
Claims 12 and 20 are objected to because of the following informalities:
The preamble of claim 12 should read “The intravascular device of [[any]] claim 1”
Claim 20, line 2 should read “to [[a]] the core of the intravascular device…” since claim 20 depends from claim 1 which introduces “a core [of the intravascular device]” in line 2 and as best understood from the specification and figures, the intravascular device has only one core.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 19 recites the limitation “a wire mesh” in line 6 which renders the scope of the claim indefinite because it is unclear if the recited wire mesh introduces a new element to the intravascular device of claim 1 or is intended to refer back to the wire mesh recited in claim 1, line 6. As best understood from the specification and figures, there is only one wire mesh. Therefore, for examination purposes, each recitation of “a wire mesh” has been interpreted as referring to the same wire mesh.
It is recommended that applicant amends claim 19, line 6 so that it reads “expanding [[a]] the wire mesh…” to alleviate the clarity issues.
Claim 20 is similarly rejected by virtue of its dependency from claim 19.
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.
Claims 1-6, 10-17 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Galdonik et al. (US 2018/0303498 A1) in view of Dubrul et al. (US 2004/0260333 A1).
Regarding claim 1, Galdonik discloses an intravascular device (100, see Fig. 1A) comprising: a core (106) having a proximal section and a distal section; a tube structure coupled to the distal section of the core (resilient members 110 and 112 form a tube structure and the distal end of the tube structure formed by resilient member 112 is coupled to core wire 106 at welded tip 118, see Fig. 1A and [0062]), wherein the tube structure comprises a first section (112) and a second section (110), the second section being disposed proximal of the first section (resilient member 110 is proximal of resilient member 112, see Fig. 1A); and an expandable element (104) disposed in a gapped region of the tube structure, wherein the gapped region is disposed between the first section and the second section (see Fig. 1A), wherein the core is coupled to the first section of the tube structure (core wire 106 is coupled to resilient member 112 at welded tip 118, see [0062]) and is free to longitudinally translate relative to the second section of the tube structure such that when the core is moved proximally relative to the second section of the tube structure, the gapped region is collapsed, and the expandable element is radially expanded (core wire 106 is capable of translating relative to resilient member 110 such that proximal movement of the core wire causes radial expansion of the fiber cartridge 104 similarly as described in [0088] and shown in Fig. 8A-8B).
Galdonik fails to teach the expandable element is a wire mesh. It is noted that the expandable element of Galdonik is used for thrombus removal by dragging the thrombus into a retrieval catheter (see [0046] and [0059]).
Dubrul, in the same field of art, teaches a related intravascular device (10, see Fig. 1-2) comprising a core wire 14, a tube structure having a first section (22) and a second section (12), an expandable element in the form of a wire mesh (16) disposed between the first section and the section, wherein the core is coupled to the first section such that when the core is moved proximally relative to the second section of the tube structure, the wire mesh is radially expanded (see [0093]). The expandable element of Dubrul is similarly used for thrombus removal and is capable of forcing a thrombus into a retrieval catheter (see [0096], [0101] and Fig. 18).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the expandable element of Galdonik (the fiber cartridge) with the expandable element of Dubrul (the braided wire mesh) since doing so would have yielded nothing more than predictable results to one of ordinary skill in the art, namely, the wire mesh of Dubrul in the intravascular device of Galdonik would similarly have been capable of removing thrombus.
Regarding claim 2, Galdonik discloses a radiopaque marker longitudinally coincident with an expandable element (radiopaque markers 158 and 160 mark the proximal and distal ends of the fiber cartridge 104, see [0025],[0086], and Fig. 5; the radiopaque markers are longitudinally coincident with the fiber cartridge since they are along the longitudinal direction of the cartridge). As discussed above, with respect to claim 1, Dubrul teaches the expandable element may comprise a wire mesh.
Regarding claim 3, Galdonik further discloses the tube structure is coupled to the core at only the distal section of the core (corewire 106 is secured at its distal end to resilient member 112, see [0062]).
Regarding claim 4, Galdonik further discloses the first section and/or second section of the tube structure includes a cut pattern comprising a plurality of circumferentially extending rings connected by axially extending beams (the tube structure formed by resilient members 110 and 112 can comprise cut tubing that is made of circumferentially extending rings disposed between pairs of cut slots 146 and connected by axially extending rails 148, see [0066] and Fig. 2B).
Regarding claim 5, Galdonik further discloses a distal end of the expandable element is connected to the first section of the tube structure and a proximal end of the expandable element is connected to the second section of the tube structure, thereby bridging the gapped region between the first and second sections (fiber cartridge 104 is connected at its distal end to resilient member 112 and at its proximal end to resilient member 110, see [0062], [0065] and Fig. 1A). As discussed above, with respect to claim 1, Dubrul teaches the expandable element may comprise a wire mesh.
Regarding claim 6, the combination of Galdonik and Dubrul teaches the intravascular device of claim 5. Galdonik further discloses wherein the expandable element (104) is connected to the first and second sections (fiber cartridge 104 is connected at its distal end to resilient member 112 and at its proximal end to resilient member 110, see [0062], [0065] and Fig. 1A). As discussed above, with respect to claim 1, Dubrul teaches the expandable element may comprise a wire mesh.
Galdonik fails to expressly teach the expandable element is connected to the first and second sections by an adhesive. However, Galdonik teaches that adhesive is a suitable way of securing components of the intravascular device together (see [0062] and [0083]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the wire mesh of Galdonik and Dubrul so that is connected to the first and second sections by an adhesive since Galdonik teaches an adhesive is suitable method of securing components of an intravascular device together.
Regarding claim 10, Galdonik further discloses the first section comprises a first cut pattern and a different, second cut pattern (resilient member 112 can comprise a cut tube pattern formed of a first cut pattern shown in Fig. 2B and a second, different cut pattern shown in Fig. 2C, see [0065] and [0066]).
Regarding claim 11, Galdonik further discloses the second section comprises a first cut pattern and a different, second cut pattern (resilient member 110 can comprise a cut tube pattern formed of a first cut pattern shown in Fig. 2B and a second, different cut pattern show in Fig. 2C, see [0065] and [0066]).
Regarding claim 12, the combination Galdonik and Dubrul teaches the intravascular device of claim 1, further comprising a radiopaque marker disposed at or near a distal tip of the device (Gladonik teaches a radiopaque marker on either side of the wire mesh as discussed with reference to claim 2 and since the wire mesh would be near the distal tip of the device, the radiopaque markers would also be near the distal tip of the device).
Regarding claim 13, Galdonik further discloses an actuation tube (108, see Fig. 1A) attached to a proximal end of the tube structure and extending proximally therefrom (overtube 108 is attached to the proximal end of resilient member 110 and extends proximally therefrom, see [0062]).
Regarding claim 14, Galdonik further discloses the actuation tube is a hypotube (overtube 108 may be a hypotube, see [0069]; reference to “overtube 104” in [0069] is understood to refer to overtube 108, consistent with [0062] and Fig. 1A).
Regarding claim 15, Galdonik further discloses the actuation tube omits a cut pattern and omits rings and beams (overtube 108 does not include any cut pattern rings or beams, see Fig. 1A).
Regarding claim 16, Galdonik further discloses the core translates with the first section and is longitudinally translatable relative to the second section and the actuation tube (core wire 106 translates relative to the resilient members 110 and overtube 108 similarly as described in [0088] and shown in Fig. 8A-8B).
Regarding claim 17, Galdonik discloses an intravascular device (100, see Fig. 1A) comprising a core (106) having a proximal section and a distal section; a tube structure coupled to the distal section of the core (resilient members 110 and 112 form a tube structure and the distal end of the tube structure formed by resilient member 112 is coupled to core wire 106 at welded 118, see Fig. 1A and [0062]), wherein the tube structure comprises a first section (112) and a second section (110), the second section being disposed proximal of the first section (resilient member 110 is proximal of resilient member 112, see Fig. 1A); and an expandable element (104) disposed in a gapped region of the tube structure, wherein the gapped region is disposed between the first section and the second section (see Fig. 1A); a first radiopaque marker disposed at or near a distal tip of the device and longitudinally coincident with the first section of the tube structure; a second radiopaque marker longitudinally coincident with the expandable element (radiopaque markers 158, 160 are each disposed near the distal end tip of the device since they are located on either side of fiber cartridge 104 which is near the distal tip of the device and they are longitudinally coincident with the first tube structure and the expandable element, see Fig. 1A, 5 and [0086]); and an actuation tube (108) attached to a proximal end of the tube structure and extending proximally therefrom (overtube 108 is attached to the proximal end of resilient element 110 and extends proximally therefrom, see [0062]), wherein the core is coupled to the first section of the tube structure and is free to longitudinally translate relative to the second section of the tube structure and relative to the actuation tube such that when the core is moved proximally relative to the second section of the tube structure and relative to the actuation tube, the gapped region is collapsed, and the expandable element is radially expanded (core wire 106 translates relative to the resilient members 110 and overtube 108 to move the fiber cartridge to the expanded position similarly as described in [0088] and shown in Fig. 8A-8B).
Galdonik fails to teach the expandable element is a wire mesh. It is noted that the expandable element of Galdonik is used for thrombus removal by dragging the thrombus into a retrieval catheter (see [0046] and [0059]).
Dubrul, in the same field of art, teaches a related intravascular device (10, see Fig. 1-2) comprising a core wire 14, a tube structure having a first section (22) and a second section (12), an expandable element in the form of a wire mesh (16) disposed between the first section and the section, wherein the core is coupled to the first section such that when the core is moved proximally relative to the second section of the tube structure, the wire mesh is radially expanded (see [0093]). The expandable element of Dubrul is similarly used for thrombus removal and is capable of forcing a thrombus into a retrieval catheter (see [0096], [0101] and Fig. 18).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the expandable element of Galdonik (the fiber cartridge) with the expandable element of Dubrul (the braided wire mesh) since doing so would have yielded nothing more than predictable results to one of ordinary skill in the art, namely, the wire mesh of Dubrul in the intravascular device of Galdonik would similarly have been capable of removing thrombus.
Regarding claims 19 and 20, the combination of Galdonik and Dubrul teaches the intravascular device of claim 1. Galdonik further teaches a method of removing a thrombus from a patient (see [0046]), the method comprising navigating an intravascular device through vasculature of the patient toward the thrombus; expanding an expandable element (104) of the intravascular device (fiber cartridge 104 has a collapsed delivery configuration shown in Fig. 1A and an expanded deployed configuration shown in Fig. 8B and [0088]); retracting the intravascular device and contacting the expanded expandable element to the thrombus; dislodging at least a portion of the thrombus (the fiber cartridge can be used in an embolectomy procedure to dislodge a thrombus and pull it into an aspiration catheter, see [0059]) and applying a proximal pulling force to the core of the intravascular device to contract the tube structure and expand the wire mesh (a proximal force is applied to the core wire 106 to transition the expandable element from the collapsed delivery configuration to the expanded configuration, see [0088] and Fig. 8A-8B). As discussed above, with respect to claim 1, Dubrul teaches the expandable element may comprise a wire mesh.
Claims 7-9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Galdonik and Dubrul, as applied to claims 1 and 17 above, and further in view of Lippert et al. (US 2018/0193607 A1).
Regarding claims 7, 8, 9 and 18, the combination of Galdonik and Dubrul teaches the intravascular device of claims 1 and 17, but fails to expressly teach one or more coils disposed within the tube structure so as to be positioned between an outer surface of the distal section of the core and an inner surface of the tube structure, wherein the one or more coils comprise a distal coil and a separate proximal coil, and wherein the wire mesh is longitudinally coincident with the proximal coil and the distal coil.
However, it is noted that Galdonik discloses resilient members 110,112 can be made of a combination of cut tubing and one or more coils (see [0065]). Galdonik is silent about the relative spatial arrangement of the cut tubing, coils and core wire.
Lippert, in the same field of art, teaches a related intravascular device (see Fig. 1-2) comprising a core wire (102) and a tube structure (104) which comprises a cut tube (see [0034]) and one or more coils (114, see [0039]) positioned between an outer surface of the distal section (112) of the core and an inner surface of the tube structure (see Fig. 2), wherein the one or more coils comprise a distal coil and a separate proximal coil (the coil 114 can be formed of a plurality of separate sections positioned adjacent to one another, thereby forming a proximal and distal coil, see [0039]). Lippert teaches that this particular arrangement improves centering of the distal section of the core wire inside the tube structure (see [0039]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the intravascular device of Galdonik and Dubrul to arrange the one or more coils between the distal section of the core and the tube structure, as taught by Lippert, since doing so would aid in centering the core wire within the tube structure.
The combination of Galdonik, Dubrul and Lippert teaches the wire mesh is longitudinally coincident with at least a portion of the proximal coil and at least a portion of the distal coil since modified Galdonik teaches the wire mesh is longitudinally coincident with resilient members 110, 112 (see Fig. 1A of Galdonik) and Lippert teaches the resilient members including coils comprising coils between the cut tube and the core wire 106.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the cited documents on the attached PTO-892 teach related intravascular devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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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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/SERENITY A MILLER/Examiner, Art Unit 3771
/SHAUN L DAVID/Primary Examiner, Art Unit 3771
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