Most 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 .
Election/Restrictions
The applicant’s election of Species 5 directed toward figures 9A-C without traverse is acknowledged.
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) 1-12, 18, 21-22, 24-26, 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Longo (2019/0247209A1).
In regard to claim 1, Longo teaches an implant (fig 6) configured to be positioned within a vessel of a patient [0012], the implant (fig 6) comprising:
a first zone 14 including first zone structures (stent wires) each configured to (i) provide a first radial force (high radial force segment 14 [0051]) and (ii) maintain a first cross-sectional shape
a second zone 18 distal to the first zone [0080: increased flexibility distally; fig 6], the second zone 18 including second zone structures (stent wires) each configured to
provide a second radial force different than the first radial force (highly flexibly segment, therefore different radial force; 0070)
transition structures 22 positioned between the first zone structures 14 and the second zone structures 18 (see fig 6), wherein each of the transition structures is configured to provide a transition radial force between the first radial force and the second radial force [0058; see fig 6];
a first coupler (flex bridges figs 6, 8) extending from and coupling one of the first zone structures 14 to a first one of the transition structures (stent wires);
and a second coupler (flex bridges fig 6, 8) extending from and coupling a second one of the transition structures (stent wires of 18) to one of the second zone structures 18.
However, the embodiment of figure 6 of Longo does not teach that the second cross sectional shape is different than the first cross sectional shape.
In the embodiment of figure 15, Longo teaches (ii) maintain a second cross-sectional shape different than the first cross-sectional shape (see figures 15, different cross sectional shape at 326 from the cross section shown at 322).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent shape of figure 15 in the stent of figure 6 of Longo because the shape assists in anchoring and maintaining patency to encourage blood flow [0082-0083].
In regard to claim 2, Longo meets the claim limitations as discussed in the rejection of claim 1, but does not each the cross sectional shapes of the zones as claimed in the embodiment of figure 6.
In the embodiment of figure 15 Longo further teaches (i) the first zone structures (wires at 322) comprise a structural element (ring of wire) having a first cross-sectional area (see figure 15 at 322),
(ii) the second zone structures (wires at 326) comprise a structural element (ring of wire) having a second cross-sectional area different than the first cross-sectional area (see 326 in figure 15),
and (iii) the transition structures (wires at 324) comprise a structural element (ring of wire) having a transition cross-sectional area between the first cross-sectional area and the second cross-sectional area (see 324 in figure 15). [0082]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent shape of figure 15 in the stent of figure 6 of Longo because the shape assists in anchoring and maintaining patency to encourage blood flow [0082-0083].
In regard to claim 3, Longo meets the claim limitations as discussed in the rejection of claim 2, but does not teach the stent shape as claimed in the embodiment of figure 6.
In the embodiment of figure 15, Longo further teaches a cross-sectional dimension (interpreted as the interior diameter which is a part of a cross section) of the first zone structures, the second zone structures, and the transition structures are equal. [0082: interior diameter is constant]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent shape of figure 15 in the stent of figure 6 of Longo because the shape assists in anchoring and maintaining patency to encourage blood flow [0082-0083].
In regard to claim 4, Longo meets the claim limitations as discussed in the rejection of claim 1, but does not teach the zone shapes as claimed in the embodiment of figure 6.
In the embodiment of figure 15 of Longo, Longo further teaches (i) the first zone structures (wires of 322) comprise a structural element (ring of wire) having a first cross-sectional area,
the second zone structures (wires of 326) comprise a structural element (ring of wire) having a second cross-sectional area less than the first cross-sectional area (see cross section in figure 15),
and (iii) the transition structures (at 324) comprise a structural element (ring of wire) having a transition cross-sectional area between the first cross-sectional area 322 and the second cross-sectional area 326 (see fig 15).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent shape of figure 15 in the stent of figure 6 of Longo because the shape assists in anchoring and maintaining patency to encourage blood flow [0082-0083].
In regard to claim 5, Longo meets the claim limitations as discussed in the rejection of claim 1,
wherein (i) the first zone structures (wires of 14) comprise a structural element (ring of wire) having a first thickness configured to provide the first radial force [0015: first thickness is greater than a third thickness],
the second zone structures (wires of 18) comprise a structural element (ring of wire) having a second thickness less than the first thickness and configured to provide the second radial force, [0014: reduction of wall thickness in the distal direction; 0015: firs thickness is greater than a first thickness] and
(iii) the transition structures (wires of 22) comprise a structural element (ring of wire) having a transition thickness between the first thickness and the second thickness and configured to provide the transition radial force. [0014: reduction of wall thickness in the distal direction; 0015: second thickness is less than a first thickness but greater than the third thickness]
In regard to claim 6, Longo meets the claim limitations as discussed in the rejection of claim 1, but does not teach the cross-sectional shape in the embodiment of figure 6.
In the embodiment of figure 15, Longo further teaches each of the transition structures (324) is configured to maintain a transition cross-sectional shape different than the first cross-sectional shape (at 322) and the second cross-sectional shape (at 326). The cross sections are shown in a cross-sectional view in figure 15.
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent shape of figure 15 in the stent of figure 6 of Longo because the shape assists in anchoring and maintaining patency to encourage blood flow [0082-0083].
In regard to claim 7, Longo meets the claim limitations as discussed in the rejection of claim 1, wherein the second radial force (radial force of 18: flexible segment) is less than the first radial force (radial force of 14: high radial force segment). [0055]
In regard to claim 8, Longo meets the claim limitations as discussed in the rejection of claim 1, wherein the transition structures (wires of 22) include a first transition structure and a second transition structure distal to the first transition structure (at least two rows of wires in the transition segment 22 of figure 6),
wherein the first transition structure (distal ring of wires of 22) is configured to provide a first transition radial force and the second transition structure (proximal ring of wires of 22) is configured to provide a second transition radial force less than the first transition radial force. (figure 6, 22 is gradual transition segment; 0058: flexibility of transition segment varies across the length; 0080: increased flexibility extending distally down the stent]
In regard to claim 9, Longo meets the claim limitations as discussed in the rejection of claim 1, wherein the transition radial force provided by each of the transition structures (wires of 22) decreases in a distal direction toward the second zone 18 such that a flexibility of the implant increases in the distal direction toward the second zone 18. [0014:reduction of wall thickness in the distal direction; 0015; 0058: flexibility over 22 may vary over the length of the segment]
In regard to claim 10, Longo meets the claim limitations as discussed in the rejection of claim 1, and further teaches (i) the first radial force (of 14) is a first radially outward force, (ii) the second radial force (of 18) is a second radially outward force, and (iii) the transition radial force (of 22) is a transition radially outward force. (see figure 5, the radial force resists compression and is therefore outwards [0033])
In regard to claim 11, Longo meets the claim limitations as discussed in the rejection of claim 1, and further teaches the first zone 14 includes a first flexibility along a length of the first zone and the second zone 18 includes a second flexibility greater than the first flexibility along a length of the second zone. [0055; 0057; fig 6]
In regard to claim 12, Longo meets the claim limitations as discussed in the rejection of claim 11, but does not teach the cross sections of the zones in the embodiment of figure 6.
In the embodiment of figure 15, Longo further teaches wherein a cross-sectional dimension (interpreted as the inner diameter) of the first zone structures (322) in the first zone is equivalent to a cross-sectional dimension of the second zone structures (326) in the second zone. [0082: inner diameter remains constant]
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent shape of figure 15 in the stent of figure 6 of Longo because the shape assists in anchoring and maintaining patency to encourage blood flow [0082-0083].
In regard to claim 18, Longo meets the claim limitations as discussed in the rejection of claim 1, wherein in an unconstrained state, each of the first zone structures, the second zone structures, and the transition structures have a cross-sectional dimension between 0.5 millimeters and 10 millimeters. [0060: 3-4mm]
In regard to claim 21, Longo meets the claim limitations as discussed in the rejection of claim 1, and further teaches the first radial force (of 14) is between 0.05 and 1.3 Newtons per millimeter of a cross-sectional dimension of the first zone. [0055: 0.75 to 1.0N/mm]
In regard to claim 22, Longo meets the claim limitations as discussed in the rejection of claim 1, and further teaches the second radial force (of section 18) is between 0.01 and 1 Newton per millimeter of a cross-sectional dimension of the second zone. [0057: radial force of 18 is .5-.7N/mm]
In regard to claim 24, Longo meets the claim limitations as discussed in the rejection of claim 1, wherein each of the first zone structures (wires of 14) and the transition structures (wires of 22) includes a peak and a valley (see close up in figure 7 of wavy pattern), and wherein the first coupler (flex bridges) extends from and couples the peak of one of the first zone structures to the valley of one of the transition structures or the valley of one of the first zone structures to the peak of one of the transition structures. (see fig 6-7)
In regard to claim 25, Longo meets the claim limitations as discussed in the rejection of claim 24, and further teaches each of the second zone structures (wires of 18) includes a peak and a valley (see fig 6-7), and wherein the second coupler (flex bridge) extends from and couples the peak of one of the transition structures to the valley of one of the second zone structures or the valley of one of the transition structures to the peak of one of the second zone structures. (fig 6-7)
In regard to claim 26, Longo meets the claim limitations as discussed in the rejection of claim 1, and further teaches (i) a third coupler (flex bridge) extending from and coupling one of the first zone structures (wires making up 14) to another one of the first zone structures (wires of 14), and (ii) a fourth coupler (flex bridge) extending from and coupling one of the second zone structures (wires of 18) to another one of the second zone structures (wires of 18). See the numerus flex bridges connecting rings in figures 6-8)
In regard to claim 30, Longo meets the claim limitations as discussed in the rejection of claim 27, but does not teach the cross-sectional shapes of each zone as claimed in the embodiment of figure 6.
In the embodiment of figure 15, Longo teaches the second zone structure (at 326) is configured to maintain a second cross-sectional shape different than the first cross-sectional shape (of 322), and the transition structure (at 324) is configured to maintain a transition cross-sectional shape different than each of the first cross-sectional shape and the second cross-sectional shape. (see figure 15, the view is cross sections of each area).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the stent shape of figure 15 in the stent of figure 6 of Longo because the shape assists in anchoring and maintaining patency to encourage blood flow [0082-0083].
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) 27-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Longo (2019/0247209A1).
In regard to claim 27, Longo discloses an implant (fig 6) configured to be positioned within venous sinuses of a patient (capable of since the venous sinus is also a blood vessel), the implant (Fig 6) comprising:
a first zone 14 including a first zone structure (wires making up stent in 14) configured to provide a first radial force to a venous sinus narrowing of the patient;
a second zone 18 distal to the first zone 14 (see fig 6), the second zone 18 including a second zone structure (wires, fig 6) configured to provide a second radial force, less than the first radial force, to the venous sinuses of the patient [0057-0058];
a transition structure 22 distal to the first zone structure 14 and proximal to the second zone structure 18, wherein the transition structure 22 is configured to provide a transition radial force less than the first radial force and greater than the second radial force [0058];
a first coupler (flex bridge) extending from and coupling the first zone structure 14 to the transition structure 22 (see flex bridges in fig 6-7);
and a second coupler (flex bridge) extending from and coupling the transition structure 22 to the second zone structure 18 (see fig 6-7).
In regard to claim 28, Longo discloses the implant of claim 27, and further discloses the first zone 14 has a first flexibility (high radial force segment, fig 6) along a length of the first zone and the second zone 18 has a second flexibility greater (high flexibility segment, fig 6) than the first flexibility along a length of the second zone,
and wherein the first flexibility is configured to maintain a patency of the venous sinus narrowing of the patient and the second flexibility is configured to maintain a patency of the venous sinuses of the patient. [0055; 0057-0058]
The flexibilities are capable of maintaining a patency of the venous sinus narrowing as the purpose of a stent is to maintain patency of a blood vessel.
In regard to claim 29, Longo discloses the implant of claim 27, and further discloses a cross-sectional dimension of the first zone structure 14, the second zone structure 18, and the transition structure 22 are equivalent [0017: inside diameter is constant; therefore cross sectional dimension of the inside of each zone will be equivalent],
and wherein (i) the first zone structure 14 comprises a structural element (wires) having a first thickness, (ii) the second zone structure 18 comprises a structural element (wires) having a second thickness less than the first thickness, and (iii) the transition structure 22 comprises a structural element (wires) having a transition thickness less than the first thickness and greater than the second thickness. [0014-0016]
Allowable Subject Matter
Claim(s) 13-15, 23 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 13, Longo meets all of the claim limitations except “the first cross-sectional shape is a circular shape and the second cross-sectional shape is a non-circular shape and/or a rounded triangular shape.”
In regard to claim 14, Longo meets all of the claim limitations except “the second transition structure is configured to maintain a second transition cross-sectional shape less circular than the first transition cross-sectional shape.”
In regard to claim 15, Longo meets all of the claim limitations except “wherein the transition cross-sectional shape maintained by each transition structure is increasingly non-circular and/or triangular in a distal direction toward the second zone”.
In regard to claim 23, Longo meets all of the claim limitations except “when in the constrained state, the implant has a circular or rounded square shape, and when in the unconstrained state, at least a portion of the implant has a non-circular and/or rounded triangular shape.”
Conclusion
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/CHRISTIE BAHENA/Primary Examiner, Art Unit 3774