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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “guide wire releasably coupled to the proximal wire attachment of the flow diverter device” of claim 23 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: Claim 23 recites “a guide wire releasably coupled to the proximal wire attachment of the flow diverter device” which is not discussed in the instant specification.
Claim Objections
Claims 1, 4, 11 and 12 are objected to because of the following informalities:
In claim 1: “comprises;” should recite - - comprises: - -.
In claim 4: “aneurism” in line 4 should recite - - aneurysm - -.
In claims 11 and 12: “radioopaque” should recite - - radiopaque - -.
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 8-11, 13-20, 23 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 8 recites “"the high-density distal cap, the low-density section, and the stent section are comprised of braided wire.” It is unclear if these elements are all comprised of one same braided wire (as the term “wire” is singular and not plural), if each of these elements are comprised of a braided wire (and therefore three different braided wire due to the presence of three different sections), or if the three elements together are comprised of a plurality of braided wires. The specification of the instant application refers to the wires in plurality in some instances ([0046] of the published application refers to “braided wires 308”), but then in other instances refer to the wire in its singular form ([0051] of the published application refers to “braided wire 608” in some instances but then “braided wires 608” in other instances). Therefore, the scope of this claim cannot be ascertained in light of the specification and renders the claim unclear.
Claim 9 recites “the braided wires from the stent section”. However, claim 8 had only previously introduced “braided wire”. Therefore, it is unclear how many wires are required by the claim (singular or plurality).
Claims 10 and 13 recite the limitation in “the braided wire”. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation in “the distal wire attachment”. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites “a guide wire releasably coupled to the proximal wire attachment of the flow diverter device”. It is unclear how the guide wire is releasably coupled to the proximal wire attachment of the flow diver device as this feature is neither shown nor discussed in the instant specification and figures.
Claim(s) 11, 14, 15, 17-20 is/are rejected as being dependent on, and failing to cure the deficiencies of, their rejected respective parent claims.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 8-11, 13, 14, 16-24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levy (US 2007/0198075).
Levy discloses the following limitations:
Claim 1. A flow diverter device (20+50), comprising:
a linear device body having a undeployed configuration and a deployed configuration (Fig. 3; [0038]), and, when in the deployed configuration, the linear device body further comprises:
a high-density distal cap (50) having an outer convex shape structurally configured to engage an aneurysm ostium (60) on a blood vessel side at a blood vessel bifurcation (Fig. 4A), such that the high-density distal cap restricts blood flow into the aneurysm from the blood vessel bifurcation ([0036], [0039]);
a low-density section (see annotated figure below) adjacent the high-density distal cap to allow blood flow through the blood vessel bifurcation (Fig. 4A; [0035], [0039]; via cell openings 42);
a stent section (see annotated figure below) adjacent the low-density section and structurally configured to stabilize the linear device body in a lumen of the blood vessel bifurcation (Fig. 4A; [0039]); and
a proximal wire attachment (30+36) at a lateral edge of the stent section (Fig. 1 illustrates a lateral right edge), wherein the stent section terminally couples to a distal end of the proximal wire attachment (at junctions 32; [0035], [0040]).
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Claim 2. The device of claim 1, wherein the low-density section includes a plurality of transverse openings (42) ([0035], [0039]).
Claim 3. The device of claim 1, wherein the high-density distal cap has a lower porosity (54) compared to the stent section and the low-density section has a higher porosity (42) compared to the stent section (Fig. 1; [0035], [0036], [0039]).
Claim 4. The device of claim 3, wherein the high-density distal cap (50) has a porosity (54) that allows sufficient blood flow into the aneurysm to inhibit thrombosis from forming on the aneurysm side of the high-density distal cap (the drip chamber 50 has a porosity that allows cell sized openings (sufficient) of blood flow into the aneurysm 62 while coated with an embolic agent 88 to inhibit thrombosis from forming on the aneurysm side of the drip chamber 50; [0036], [0039], [0043]) and that restricts sufficient blood flow into the aneurysm to facilitate endothelialization on the high-density distal cap (the blocking (restriction) of all but cell sized openings of blood flow into the aneurysm 62 thus allows for the capacity of endothelialization on the drip chamber 50; paras [0036], [0039]).
Claim 8. The device of claim 1, wherein the high-density distal cap, the low-density section, and the stent section are comprised of braided wire ([0035], [0036]; e.g. woven metallic fibers).
Claim 9. The flow diverter device of claim 8, wherein the proximal wire attachment is positioned lateral to a central axis of the linear device body when in the deployed configuration (Fig. 1) and the braided wires from the stent section converge at the proximal wire attachment (at least two braided wires converge at each of junction 32 in Fig. 1).
Claim 10. The flow diverter device of claim 1, further comprising a distal wire attachment (52) coupled to distal ends of the braided wire of the low-density section and aligned along a central axis of the linear device body when in the undeployed configuration (Fig. 1).
Claim 11. The flow diverter device of claim 10, wherein the distal wire attachment (52) includes a radiopaque material as a radiopaque distal marker ([0036]).
Claim 13. The flow diverter device of claim 1, wherein the braided wire is a shape memory braided wire ([0037]).
Claim 14. The flow diverter device of claim 10, wherein the shape memory braided wire includes a nickel alloy ([0037]).
Claim 16. The flow diverter device of claim 8, wherein the braided wire comprises a plurality of braided wire segments each extending from the proximal wire attachment (30+36) to the distal wire attachment (52) (Figs. 1-2).
Claim 17. The flow diverter device of claim 16, wherein each braided wire segment of the plurality of braided wire segments is the same length (in light of the 35 U.S.C. 112 rejection above, it is unclear the scope of the “braided wire” and therefore subsequently the scope of “a plurality of braided wire segments”. Figs. 1-3 the wires extending from the proximal wire attachment (30+36) to the distal wire attachment (52) to be about the same length as the device is symmetrical over a longitudinal axis) .
Claim 18. A different interpretation of the distal wire attachment is used for this claim. The distal wire attachment is first introduced in this claim dependency in claim 16, and therefore the limitations of claim 16 will be re-rejected here as well:
The flow diverter device of claim 8, wherein the braided wire comprises a plurality of braided wire segments each extending from the proximal wire attachment (30+36) to the distal wire attachment (distal apex of drip chamber 50; wherein the term “attachment” does not require a specific structure, and therefore any portion the distal wire intersects can be considered an attachment (point)) (Figs. 1-2); wherein the braided wire increases in density from the periphery of the high-density distal cap (from the wider base portion of drip chamber 50) to the distal wire attachment (the density increases as seen in Fig. 1; where it is the most dense at the apex of drip chamber 50).
Claim 19. The flow diverter device of claim 16, wherein the distal wire attachment (52) is aligned along a central axis of the linear device body when in the undeployed configuration (Fig. 1).
Claim 20. A different interpretation of the distal wire attachment is used for this claim. The distal wire attachment is first introduced in this claim dependency in claim 16, and therefore the limitations of claim 16 will be re-rejected here as well:
The flow diverter device of claim 8, wherein the braided wire comprises a plurality of braided wire segments each extending from the proximal wire attachment (30+36) to the distal wire attachment (see annotated below; wherein the term “attachment” does not require a specific structure, and therefore any portion the distal wire intersects can be considered an attachment (point);, wherein the distal wire attachment is offset from a central axis of the linear device body when in the undeployed configuration (see annotated figure below).
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Claim 21. A method for diverting blood flow from an aneurysm through a blood vessel bifurcation, comprising:
positioning a delivery catheter (74) containing the flow diverter device of claim 1 at an aneurysm (62) of the blood vessel bifurcation (Fig. 7; [0040]);
removing the catheter from the flow diverter device to transition the flow diverter device from the undeployed configuration to the deployed configuration, such that the high-density distal cap of the flow diverter device is positioned against an ostium (60) of the aneurysm to divert blood flow from the aneurysm to secondary blood vessels of the blood vessel bifurcation (Fig. 8; [0035], [0039], [0040]).
Claim 22. The method of claim 21, wherein the flow diverter device is repositioned to align the high-density distal cap with the ostium of the aneurysm (the stent device 20 is allowed repositioned to be aligned via guidewire 72 the drip chamber 50 with the neck 60 of the aneurysm 62; [0039]-[0040]), either during the transition from the undeployed configuration to the deployed configuration (during the expansion and transition from the undeployed configuration to the deployed configuration; [0039]-[0040]), following the transition from the undeployed configuration to the deployed configuration, or following at least partial retraction of the flow diverter device into the delivery catheter.
Claim 23. A system for diverting blood flow from an aneurysm to secondary blood vessels of a blood vessel bifurcation, comprising:
a delivery device (74) configured to move through a system of blood vessels to a blood vessel bifurcation (Fig. 7; [0040]);
the flow diverter device of claim 1 positioned in a lumen of the delivery device (Fig. 7; [0040]);
a guide wire (72) releasably coupled to the proximal wire attachment of the flow diverter device and positioned in the lumen of the delivery device, the guide wire configured to maintain a position of the flow diverter device as the delivery device is removed from the flow diverter device ([0040], i.e. the guide wire is considered coupled to the proximal wire attachment when the guide wire is positioned in the lumen of delivery catheter 74 as this couples all elements of the system together).
Claim 24. The system of claim 21, wherein the delivery device is a delivery catheter (74) ([0040]).
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.
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.
Claim(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Hayashi et al (US 2007/0173917).
Claims 5 and 6. Levy disclose the invention substantially as claimed above but fails to disclose the high-density distal cap has a porosity of from about 15% to about 55% (as per claim 5) or the high-density distal cap has a porosity of from about 30% to about 40% (as per claim 6).
However, in a field of similar endeavor, Hayashi discloses the high-density distal cap has a porosity of about 40% (a blood vessel prosthetic device that has a porosity of about 40%; [0057]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the high-density distal cap of Levy to have a porosity of in the claimed range, as taught by Hayashi et al, in order to gain the advantages of setting the desired value of expansion ratio and expansion conditions while providing flexibility and decreasing the outer diameter ([0057]).
Furthermore, Applicant has not provided evidence of the criticality of the claimed porosity in the instant specification. In paragraph [0054] of the instant specification publication, Applicant discloses exemplary porosities of the device in order to divert blood flow (“One skilled in the art can readily ascertain a proper porosity/density of the high-density distal cap to achieve such a result, once in possession of the present disclosure. In one example, however, the density of the high-density distal cap can be from about 40% to about 85% or from about 50% to about 70%. In some examples the porosity of the high-density distal cap can be from about 15% to about 55% or from about 25% to about 45%”). However, Applicant has not provided evidence, such as how the specific claimed porosities have unexpected results in diverting flow. It appears that applicant places no criticality on the range claimed, indicating simply that the porosities “can” be within the claimed ranges. Therefore, the claimed range is merely a range discoverable by routine skill in the art and fails to patentably distinct the claimed invention of claims 5 and 6 from the prior art.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Nageswaran et al (US 2021/0259866).
Claim 7. Levy discloses the invention substantially as claimed above, including the the high-density distal cap and the low-density section are comprised of braided wire ([0035], [0036]) but fails to disclose the stent support is a laser cut stent support. Instead, Levy also discloses the stent support is made of braided wires ([0035]).
However, in a similar field of endeavor, Nageswaran et al teaches when a stent support is used as a flow diverter in a blood vessel, the stent support may be made from a woven stent (akin to the stent of Levy), or alternatively be made of a laser cut stent ([0123]). Therefore, since both the stent support of Levy and Nageswaran et al are used as a support stent in a flow diverter, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute one known stent (woven/braided stent of Levy) with another (laser cut stent of Nageswaran et al) to provide the predictable result of a stent structure capable of providing support in the blood vessel during use as a flow diverter.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Hannes et al (US 2014/0058420).
Claim 12. Levy discloses the invention substantially as claimed above, but fails to disclose the proximal wire attachment includes a radiopaque material as a proximal marker.
However, in the same field of endeavor, Hannes et al teaches a device (1) for treating an aneurysm (A) at a bifurcation (Fig. 2), wherein the device comprises a stent section (3) having a radiopaque material as a proximal marker (7) at the proximal wire attachment (9) (Fig. 4; [0056]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Levy to have the proximal wire attachment include a radiopaque material as a proximal marker as taught by Hannes et al so the user can visually see and identify the point of connection of where the flow diverter device will be released.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Levy in view of Cox et al (WO 2014/159746).
Claim 15. Levy discloses the invention substantially as claimed above, but fails to disclose the braided wire is a drawn filled tubing wire.
However, in a similar field of endeavor of treating aneurysms, Cox teaches he braided wires of the device can be tubular braids of metal wires as Nitinol (akin to the device of Levy), or they may be drawn filled tubing wires made of Nitinol ([0093]). Therefore, since both the devices of Levy and Cox et al are used as a flow diverter in treating an aneurysm, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to substitute one structure (woven/braided wires of Levy) with another (drawn filled tubing wire of Cox et al) to provide the predictable result of a structure capable of providing support in the blood vessel during use as a flow diverter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE M SHI whose telephone number is (571)270-5620. The examiner can normally be reached Mon-Thurs, 8-5 EST.
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/KATHERINE M SHI/Primary Examiner, Art Unit 3771