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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yang (US 20090171293 A1; cited by applicant).
With respect to claim 1, Yang discloses a medical device (see Fig. 1 and paragraph 0021, self-expanding guide wire system #100), comprising:
an expandable tool configured to extend from a distal end of the medical device (see Fig. 1 and paragraph 0021, expandable anchoring portion #104 of elongate member #101 which extends from a distal end of #100), the expandable tool comprising:
a plurality of wires extending from a proximal end of the expandable tool to a distal end of the expandable tool (see Fig. 1 and paragraph 0024, expandable anchoring portion #104 comprises a plurality of expandable members #112 which extend from proximal to distal end of #104),
a plurality of fins extending outwardly from each of the wires of the plurality of wires (see Fig. 9 and paragraph 0034, expandable members #112 may comprise any number of hooks #900), and
a plurality of projections extending outwardly from each of the fins of the plurality of fins (see Fig. 9 and paragraph 0034, hooks #900 may comprise bards #906 that outwardly project from the hooks #900).
With respect to claim 2, all limitations of claim 1 apply in which Yang further discloses wherein the plurality of wires defines a plurality of legs (see Fig. 1, #112 defines a plurality of legs as there are multiple wires), and wherein each of the legs of the plurality of legs branch out from a central trunk disposed at the proximal end of the expandable tool (see Fig. 1 and paragraph 0027, #112 helically extends between proximal #120 and distal cannulas #121 to form braided structure where Fig. 7 shows that #112 branch out from #120 at the proximal end).
With respect to claim 3, all limitations of claim 2 apply in which Yang further discloses wherein the plurality of legs are joined together at the distal end of the expandable tool (see Fig. 7, #112 join together at anchoring device #168 at distal end of expandable anchoring portion #104).
With respect to claim 4, all limitations of claim 1 apply in which Yang further discloses wherein the expandable tool is configured to be transitioned from a collapsed configuration to an expanded configuration (see paragraph 0004, expandable anchoring portion #104 self-expands from a collapsed configuration to an expanded configuration).
With respect to claim 5, all limitations of claim 4 apply in which Yang further discloses wherein, in the collapsed configuration, each of the fins of the plurality of fins is configured to collapse inward toward the plurality of wires (see Fig. 9 and paragraph 0034, expandable members #112 may comprise any number of hooks #900; and see paragraph 0026, in the collapsed state the expandable anchoring portion #104 with the expandable member #112 and its hooks #900 are collapsed inward to be parallel to the axis of elongate member #101 and constrained by a sheathing member #107).
With respect to claim 6, all limitations of claim 4 apply in which Yang further discloses wherein, in the expanded configuration, each of the wires of the plurality of wires is configured to bow outward such that each of the wires has a concave profile (see paragraph 0025, in the expanded configuration that expandable members #112 radially bows outwards as see in Fig. 1).
With respect to claim 7, all limitations of claim 4 apply in which Yang further discloses wherein, in the collapsed configuration, an outer diameter of the expandable tool is no greater than 1.5 mm (see paragraph 0030 and Fig. 1, the diameter of distal tip #125 may range from about 0.2 inches to about 0.05 inches which is about 5mm to 1.27 mm which is the region at which the distal end of the expandable members #112 taper down and converge when the expandable anchoring member #104 is collapsed; 1 inch = 25.4 mm).
With respect to claim 8, all limitations of claim 4 apply in which Yang further discloses wherein, in the expanded configuration, a width of the expandable tool is in a range of 1 mm to 15 mm (see paragraph 0028, the expandable anchoring portion #104 in its expanded configuration has an expanded diameter between 3mm to about 40mm).
With respect to claim 9, all limitations of claim 1 apply in which Yang further discloses wherein the wires of the plurality of wires comprise a first material (see paragraph 0029, expandable members #112 are formed from a shape memory material such as nitinol), and wherein the fins of the plurality of fins comprise a second material (see paragraph 0022, structures part of the elongate member #101 including the hooks #900 need only be biocompatible with each other and includes nitinol).
With respect to claim 10, all limitations of claim 9 apply in which Yang further discloses wherein the first material is the same as the second material (see paragraph 0022 and 0029, both first material and second material are nitinol).
With respect to claim 11, all limitations of claim 9 apply in which Yang further discloses wherein the projections of the plurality of projections comprise a third material (see paragraph 0022, structures part of the elongate member #101 including the bards #906 need only be biocompatible with each other and includes nitinol)
With respect to claim 12, all limitations of claim 11 apply in which Yang further discloses wherein the third material is the same as the second material (see paragraph 0022 and 0029, both the third material and second material are nitinol).
With respect to claim 13, all limitations of claim 1 apply in which Yang further discloses wherein the fins of the plurality of fins are integrally formed with the wires of the plurality of wires (see Fig. 9 and paragraph 0034, hooks #900 are integrally formed with #112 as they engage with body lumen).
With respect to claim 14, all limitations of claim 1 apply in which Yang further discloses wherein the projections of the plurality of projections extend radially outward relative to a longitudinal axis of each of the fins of the plurality of fins (see Fig. 9 and paragraph 0034, bards #906 extend radially outward relative to hooks #900)
With respect to claim 15, all limitations of claim 1 apply in which Yang further discloses wherein the wires of the plurality of wires extend approximately parallel to a longitudinal axis of the expandable tool in a collapsed configuration of the expandable tool (see paragraph 0026, in the collapsed state the expandable anchoring portion #104 with the expandable member #112 and its hooks #900 are collapsed inward to be parallel to the axis of elongate member #101 and constrained by a sheathing member #107).
With respect to claim 16, all limitations of claim 16 apply in which Yang discloses a medical device (see Fig. 1 and paragraph 0021, self-expanding guide wire system #100), comprising:
an expandable tool configured to extend from a distal end of the medical device (see Fig. 1 and paragraph 0021, expandable anchoring portion #104 of elongate member #101 which extends from a distal end of #100), the expandable tool comprising:
a plurality of wires extending from a proximal end of the expandable tool to a distal end of the expandable tool (see Fig. 1 and paragraph 0024, expandable anchoring portion #104 comprises a plurality of expandable members #112 which extend from proximal to distal end of #104),
wherein, in an expanded configuration of the expandable tool, each of the wires of the plurality of wires is configured to be curved outward to form a basket (see paragraph 0025-0026, in the expanded configuration that expandable members #112 radially bows outwards as see in Fig. 1 to create a basket like structure),
wherein each of the wires of the plurality of wires includes a first portion configured to extend inwardly relative to a profile of the wire (see Fig. 1, expandable members #112 has a first section that extends inward towards a longitudinal axis of elongate member #101 as see in Fig. 1), and a second portion configured to extend outwardly relative to the profile of the wire (see Fig. 1, expandable members #112 has a second section that extends outwards away from a longitudinal axis of elongate member #101 as see in Fig. 1), and
wherein the wires of the plurality of wires are configured to be joined together at the distal end of the expandable tool (see Fig. 7, #112 join together at anchoring device #168 at distal end of expandable anchoring portion #104).
With respect to claim 17, all limitations of claim 16 apply in which Yang further discloses wherein the wires of the plurality of wires include sharpened wires (see paragraph 0033 and Fig. 8, expandable members #112 have serrated edges #801 therefore making them sharp).
With respect to claim 18, all limitations of claim 16 apply in which Yang further discloses wherein the wires of the plurality of wires include textured wires (see paragraph 0036 and Fig. 13, expandable members #112 have bards #1201 that angle outwardly which therefore makes the wires textured).
With respect to claim 19, Yang discloses a method for collecting a tissue sample using a medical device (see paragraph 0040, method of using wire guide system #100; and see Fig. 1 and paragraph 0021, self-expanding guide wire system #100), the method comprising:
navigating an expandable tool to a target site within a lumen of a patient (see paragraph 0040-0043, navigating an endoscope #201 until it reaches a target site within a lumen of a patient and loading the sheathing member #107 into the working channel of the endoscope and further loading the wire guide #108 into the sheathing member which includes #104; and see Fig. 1 and paragraph 0021, expandable anchoring portion #104 of elongate member #101 which extends from a distal end of #100), the expandable tool comprising:
a plurality of wires extending from a proximal end of the expandable tool to a distal end of the expandable tool (see Fig. 1 and paragraph 0024, expandable anchoring portion #104 comprises a plurality of expandable members #112 which extend from proximal to distal end of #104),
a plurality of fins extending outwardly from each of the wires of the plurality of wires (see Fig. 9 and paragraph 0034, expandable members #112 may comprise any number of hooks #900), and
a plurality of projections extending outwardly from each of the fins of the plurality of fins (see Fig. 9 and paragraph 0034, hooks #900 may comprise bards #906 that outwardly project from the hooks #900).
transitioning the expandable tool from a collapsed configuration to an expanded configuration (see paragraph 0043, after the sheathing member #107 has reached target site, the proximal end is retracted to unconstraint a portion of the expandable anchoring portion #104 and therefore allow self-expansion of the expandable anchoring portion #104 to transition from collapsed to expanded); and
contacting a wall of the lumen with the plurality of projections such that the tissue sample is collected on the projections (see paragraph 0043, the expandable anchoring portion #104 is fully radially expanded and thus engages the walls of body lumen such that tissue sample is collected within the bards #906).
With respect to claim 20, all limitations of claim 19 apply in which Yang further discloses further comprising, after contacting the wall of the lumen, transitioning the expandable tool from the expanded configuration to the collapsed configuration (see paragraph 0046, after a procedure the sheathing member #107 is introduced to re-sheath the expanded expandable anchoring portion #104 to transition it from expanded to collapsed).
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791