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
Claim(s) 23, 32-33 is/are objected to because of the following informalities:
In regard to claim 23, “fist” should be spelled “first”.
In regard to claim 32, “each hood” in line one of the claim should be “each of the hoods” or “each of the first and the second hoods” for consistent antecedent basis throughout.
In regard to claim 33, “wherein when an inflation balloon is inflated at each distal end of each distal limb of the Y-shaped flow diversion device” appears to either be missing language at the end of the claim or need the term “when” deleted from the claim.
Appropriate correction is required.
Claim Interpretation
In regard to claim 28, PVA is interpreted as “polyvinyl alcohol” as noted in the instant disclosure.
In regard to claim 29, PTFE is interpreted as “polytetrafluoroethylene” as noted in the instant disclosure.
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) 22-25, 29-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaknovich (5669924A) in view of Ohri (2009/0259286A1).
In regard to claim 22, Shaknovich teaches a system for deploying an expandable Y-shaped flow diversion device (stent, 6) comprising:
a guide catheter 14 with a distal end (toward Y branch in figure 14A) and a proximal end (toward surgeon/exit point), wherein the distal end (toward y branch) of the guide catheter 14 is configured to be advanced to a branch point aneurysm (intended use, capable of since the stent is configured to be deployed in a y-shaped vessel; see figure 14A);
a first internal catheter 7a and a second internal catheter 7b disposed within the guide catheter 14 (figures 14-17);
an expandable (abstract: expandable, see fig 14) Y-shaped flow diversion device (stent, 6) disposed within the guide catheter 14 in a constrained configuration, the Y-shaped flow diversion device 6 comprising:
a wire stent frame (fig 14-17, stent 6 is made of wires) comprising a plurality (defined as two or more) of wire elements (see wire pattern of 6 in figure 14A), the wire stent comprising a proximal limb 8, a first distal limb (left branch of stent 6, fig 14A), and a second distal limb (right branch of stent 6, fig 14A) wherein the proximal limb 8 and the first and second distal limbs (right and left arms of 6 in figure 14A) converge at a crotch of the wire stent frame (intersection of the Y point of the stent 6 in figure 14A),
wherein the first internal catheter 7a and the second internal catheter (7b) are each disposed within the proximal limb 8 (fig 14A) and the first internal catheter 7a is disposed within the first distal limb (left branch of stent 6, see fig 14A) and the second internal catheter 7b is disposed within the second distal limb (right branch of stent 6, see figure 14A)
wherein the two distal limbs (branched arms of stent 6) are closer to the distal end of the guide catheter 14 than the proximal limb 8 when the expandable Y-shaped flow division device (stent 6) is disposed within the guide catheter 14. (see fig 14A) This is interpreted to mean the branched end of the stent is released from the guide catheter first. See figure 14A.
However, Shaknovich does not teach a first hood and a second hood.
Ohri teaches a hood 700 [0029: sheath disposed at or near the distal end 211 of the catheter] wherein the first hood 700 is disposed around a distal tip of the first distal limb (around distal tips of stent as shown in figures 8-9 for example) to constrain the first distal limb of the Y-shaped flow diversion device (fig 8-9). When the hood is applied to the distal limbs of Shaknocich, the distal limbs are surrounded by the guide catheter and therefore the hood also will be. (fig 2A)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the catheter of Shaknovich to include a hood at each of the distal ends of the Y-shaped diversion device as taught by Ohri in order to protect the distal ends from snagging on any portion of the delivery system or the patient’s vasculature.
In regard to claim 23, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, but does not teach the hood as claimed.
Ohri further teaches the first hood 700 is coupled to a distal end of the fist internal catheter. Since Ohri teaches the hood 700 is coupled to a distal end of the diversion device (stent) as shown in figures 8-9, when combined with the invention of Shaknovich and to the distal stent of Shaknovich, the hood will also be coupled to the distal end of the first internal catheter 7a since the catheter of Shaknovich is within the stent of Shaknocich 6. The hood will be coupled by fitting within.
In regard to claim 24, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, but does not teach the hood as claimed.
Ohri further teaches the second hood 700 is coupled to a distal end of the second internal catheter. Since Ohri teaches the hood 700 is coupled to a distal end of the diversion device (stent) as shown in figures 8-9, when combined with the invention of Shaknovich and to the distal stent of Shaknovich, the hood will also be coupled to the distal end of the second internal catheter 7a since the catheter of Shaknovich is within the stent of Shaknocich 6. The hood will be coupled by fitting within.
In regard to claim 25, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, but does not teach the hood as claimed.
As discussed in the rejection of claim 22, Ohri teaches the hood 700 is applied to a distal end of each of the arms of the flow diversion device.
Since Ohri teaches the hood 700 is coupled to a distal ends of the diversion device (stent) as shown in figures 8-9, when combined with the invention of Shaknovich and to the distal stent of Shaknovich, the hood will also be coupled to the distal end of each of the internal catheters 7a,b since the catheter of Shaknovich is within the stent arms of Shaknocich 6. The hoods will be coupled by fitting within.
In regard to claim 29, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, but does not teach the first or second hood as claimed.
Ohri further teaches the first hood and the second hood are PTFE. [0035]
In regard to claim 30, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, and further teaches the expandable Y-shaped flow diversion device 6 is balloon expandable. (abstract: stents may be deployed in both branches of the vessel simultaneously by expanding the deployment segment by an ancillary means such as one or more balloon catheters; fig 16-17)
In regard to claim 31, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, and further teaches the expandable Y-shaped flow diversion 6 device is self-expandable. (may be Nitinol; Nitinol is inherently self-expanding; Col 13, lines 60-68; may be self-expanding: Col 16, lines 35-42; where a stent is a self-expanding stent: Col 17, line 63; Col 3, lines 54-58)
In regard to claim 32, Shankovich meets the claim limitations as discussed in the rejection of claim 22, but does not teach each hood as claimed.
Ohri further teaches each hood 700 comprises a longitudinal line of perforations 204 that extend only a portion of a length of the hood from a proximal end of each hood toward a distal end of each hood, (figure 8, 0053: slit 708 does not extend all the way to the edge of the sheath)
and wherein the longitudinal line of perforations 204 are configured to split and release the distal tip of the distal limb. (figure 5: entire sheath ruptures to release stent, including the distal tip of the limb).
As discussed in the rejection of claim 22, the hood of Ohri is applied to each of the ends of the flow diversion device of Shakovich, resulting in a first hood and second hood and releasing both the first distal limb and second distal limb.
However, the combination of Shakovich in view of Ohri does not teach multiple lines of perforations.
It has been held that a mere duplication of the working parts of an invention, yielding a predictable result, requires no more than routine skill in the art. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a plurality (two or more) of lines of perforations instead of just one in order to reduce the amount of force necessary to expand the stent. Absent a teaching of criticality (new or unexpected results), this arrangement is deemed to have been known by those skilled in the art at the time the invention was filed. MPEP 2144.04
In regard to claim 33, Shaknovich meets the claim limitations as discussed in the rejection of claim 32, and further teaches when an inflation balloon (1b, 1a) is inflated at each distal end of each distal limb of the Y-shaped flow diversion device 6. (fig 16-17; inflated across an entire length of the diversion device, including at each distal end)
In regard to claim 34, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, but does not teach the first hood and second hood as claimed.
Ohri further teaches the first hood and the second hood each comprises flaps. (partially torn hood 700 has flaps as shown in figure 9)
As discussed in the rejection of claim 22, when applied to the invention of Shaknovich the hood of Ohri will be applied to each of the branches of the stent of Shaknovich which result in a first and second hood as claimed.
In regard to claim 35, Shakovich meets the claim limitations as discussed in the rejection of claim 34, but does not teach the first or second hood.
Ohri teaches the flaps of the first hood (sides of the sheath around 704) are disposed around the distal tip of the first distal limb (around distal stent within as shown in figures 7-9).
As discussed in the rejection of claim 22, when applied to the flow diversion device of Shakovich, the hood and therefore flaps will be around the distal end of each arm of the flow diversion device.
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaknovich (5669924A) in view of Ohri (2009/0259286A1) and further in view of Campbell (WO2013/074185A1).
In regard to claim 28, Shaknovich meets the claim limitations as discussed in the rejection of claim 22, but does not teach the hood as claimed.
While Ohri teaches the hoods as discussed in the rejection of claim 22 but does not teach the hood is PVA.
Campbell teaches the first hood and the second hood are PVA. [0085: the wetting agent on said outer sheath comprises polyvinyl alcohol]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the PVA coating of Campbell on the hoods of Shaknovich in view of Ohri because the coating will allow the sheath to instantaneously wet out when contacted by bodily fluids [0098; 00158] since the coating will reduce friction upon application of fluid and reduce infection incidence.
Claim(s) 37-38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shaknovich (5669924A) in view of Ohri (2009/0259286A1) and further in view of Eker (2019/0380852).
In regard to claims 37-38, Shaknovich meets the claim limitations as discussed in the rejection of claim 22 but does not teach a pusher catheter as claimed.
Eker teaches a pusher catheter 500 that is disposed within the guide catheter (delivery catheter 110), wherein proximal ends of the two internal catheters are coupled to the pusher catheter (couples to guide catheter and therefore will be coupled to the internal catheters of Shaknovich when combined in order to function properly; paragraph 14);
a distal end of the pusher catheter 500 comprises a cuff 250 that is disposed around a proximal end of the proximal limb of the Y-shaped flow diversion device. (fig 8)
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the pusher catheter of Eker in the invention of Shaknovich because the pusher catheter will aid in releasing the stent into the body.
Allowable Subject Matter
Claim(s) 26-27, 36 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
In regard to claim 26, Shaknovich (5669924A) in view of Ohri (2009/0259286A1) meets all of the claimed limitations except “the first hood remains coupled to the distal end of the first internal catheter when the first hood is released from the distal tip of the first distal limb and the second hood remains coupled to the distal end of the second internal catheter when the second hood is released from the second distal limb.”
In regard to claim 27, Shaknovich (5669924A) in view of Ohri (2009/0259286A1) meets all of the claimed limitations except “wherein the first hood remains coupled to the distal end of the first internal catheter when the first distal limb expands and releases the first hood from the distal tip of the first distal limb
and the second hood remains coupled to the distal end of the second internal catheter when the second distal limb expands and releases the second hood from the distal tip of the second distal limb.”
In regard to claim 36, Shaknovich (5669924A) in view of Ohri (2009/0259286A1) meets all of the claimed limitations except “the flaps of the first hood and the flaps of the second hood flip distally to release the first distal limb from the first hood and the second distal limb from the second hood” in combination with the other claimed limitations.
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774
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