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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-7, 11-15, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munsinger et al. US 20130110223 A1, herein referred to as Munsinger, in view of Adams et al. US 8574219 B2, herein referred to as Adams, as evidenced by Nargatti K, Ahankari S. Advances in enhancing structural and functional fatigue resistance of superelastic NiTi shape memory alloy: A Review. Journal of Intelligent Material Systems and Structures. 2021;33(4):503-531. doi:10.1177/1045389X211023582, herein referred to as Nargatti (furnished with previous non-final office action), and further in view of Vrba et al. WO 0027309 A1, herein referred to as Vrba.
Regarding claim 1, Munsinger discloses a stent delivery system (Annotated Fig. 1, stent delivery system 10 below) adapted to deliver and release a self-expanding stent (Annotated Fig. 3, stent 34 below, [0004], lines 1-4) with reduced energy loss within the stent delivery system ([0041], lines 11-14, Munsinger teaches using lubrication in system), the stent delivery system, comprising: an inner member (Annotated Fig. 3, inner shaft 20 below) including a stent receiving region (Annotated Fig. 3, below) adapted to accommodate a self-expanding stent therein [0034]; a proximal member (Fig. 5, outer member 50) extending coaxially about the inner member ([0041]), the proximal member having a distal end terminating near the stent receiving region (Annotated Fig. 1 below, [0026]); a deployment sheath (Fig. 4, deployment sheath 16) extending coaxially about the inner member and the proximal member ([0041], “Thus, along at least a portion of the length of system 10, system 10 may include four tubular structures that may be coaxially arranged--namely outer member 50, deployment sheath 16, intermediate tube 36, and inner member 20”, Annotated Fig 1 below, elements share the same axis), the deployment sheath movable between a distal position in which the deployment sheath constrains the self-expanding stent (Fig. 4) and a proximal position ([0041], [0042], abstract, [26], [36] slidable deployment sheath which moves from a distal position to a proximal position) in which the self-expanding stent is no longer constrained by the deployment sheath ([0026]), the deployment sheath including a stretch-reducing braided member forming part of the deployment sheath and adapted to resist an increase in length of the deployment sheath in response to a tensile force applied to the deployment sheath during deployment of the self-expanding stent (Fig. 5, reinforcement 51; [0041] teaches braiding of member [0041]);
wherein [a] buckle-reducing […] member (48) and the stretch-reducing […] member (Fig 5, 51) respectively reduce compression of the proximal member and elongation of the deployment sheath in order to reduce energy loss within the stent delivery system ([0057] & [0064], Munsinger uses superelastic material. As evidenced by Nargatti, see page 505 ¶ 0002 & page 521 ¶0001, superelastic materials have reduced stretchability, collapsibility and energy loss by lowering strain in system when compared to non-superelastic materials).
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Munsinger et al. Annotated Figure 1.
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Munsinger et al. Annotated Figure 3.
Munsinger fails to disclose the proximal member including a buckle-reducing member that is adapted to reduce collapsibility within the proximal member
But Adams discloses a similar stent delivery system (Fig 1, catheter 10). Adams teaches the proximal member (Fig 2, strain relief member 32) including a buckle-reducing […] member forming part of the proximal member and adapted to resist a decrease in length of the proximal member in response to a compressive force applied to the proximal member during deployment of the self- expanding stent (Fig 1, metallic tubular member 40; Col 4, lines 23-42, Adams teaches flexibility in member, member would be capable of reducing collapsibility).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify Munsinger to incorporate the proximal member including a buckle-reducing member that is adapted to reduce collapsibility within the proximal member as taught and suggested by Adams in order to provide flexibility (Adams Col 4, lines 23-42).
However, the combination of Munsinger and Adams fails to explicitly disclose wherein the buckle-reducing member is braided.
Yet, in the same field of endeavor, Vrba discloses a similar stent delivery system (Fig 1a, 110). Vrba teaches wherein the buckle-reducing member (Fig 1a, 114) is braided (pg 7, lines 17-27).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the buckle-reducing member of the buckling-reducing member as made of the combination of Munsinger and Adams to incorporate wherein the buckle-reducing member is braided, as taught and suggested by Vrba in order to maintain catheter integrity (Vrba pg 7, lines 17-27).
Regarding claim 2, the combination of of Munsinger, Adams, and Vrba as discussed above with regards to claim 1 teaches a gear rack assembly (Munsinger Fig. 6, gear rack assembly 52) coupled to the deployment sheath (Munsinger Fig. 4, deployment sheath 16, [0042]); and a handle (Munsinger Fig. 1, handle 14) coupled to the inner member and to the deployment sheath [0006]; wherein the handle includes an actuation member (Munsinger Fig 1, actuation member 18), the actuation member being coupled to the gear rack assembly so that actuation of the actuation member shifts the longitudinal position of the gear rack assembly and the deployment sheath relative to the stent receiving region (Munsinger Annotated Fig. 3 above, [0026], retraction caused by the thumb actuator longitudinal shift as claimed).
Regarding claim 3, the combination of Munsinger, Adams, and Vrba as discussed above with regards to claim 1 teaches wherein the deployment sheath (Munsinger Fig. 4, deployment sheath 16) comprises: an inner polymeric layer (Adams Fig 3B, metallic tubular member 40, Col. 4, lines 6-22, alloys described meet the polymeric definition) and an outer polymeric layer (Adams Fig 3B, polymeric member 50), with the stretch-reducing member braid (Munsinger Fig. 5, reinforcement 51) disposed between the inner polymeric layer and the outer polymeric layer (Munsinger [0040]).
Regarding claim 4, the combination of Munsinger, Adams, and Vrba as discussed above with regards to claim 3 teaches wherein the stretch-reducing member (Munsinger Fig. 5, reinforcement 51) comprises a stainless steel (Munsinger [0058], [0056]) braid (Vrba pg 7, lines 17-27; Vrba also explicitly teaches wherein the braided member is comprised of stainless steel).
Regarding claim 5, the combination of Munsinger, Adams, and Vrba as discussed above with regards to claim 4 teaches wherein the stretch-reducing braided member includes axially aligned wires extending within a braid pattern of the stretch-reducing braided member (Munsinger Fig. 5, reinforcement 51 [0038] & [0026]; Munsinger teaches using an elongation member coupled to the deployment sheath to deliver stent, device cause elongation via tensile force as claimed; Vrba pg 7, lines 17-27; Vrba also explicitly teaches braiding the member).
Regarding claim 6, the combination of Munsinger, Adams, and Vrba as discussed above with regards to claim 3 teaches wherein the buckle-reducing member braided (Adams Fig 3B, metallic tubular member 40; Vrba pg 7, lines 17-27) but does explicitly disclose wherein the buckle-reducing braided member is encapsulated within a polymeric layer.
However, Adams in another embodiments discloses a similar stent delivery system. Adams teaches wherein the buckle-reducing braided member is encapsulated within a polymeric layer (Adams Fig 3B, polymeric member 50).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the combination of Munsinger and Adams to incorporate wherein the buckle-reducing member is encapsulated within a polymeric layer as taught and suggested by Adams in order to tightly fit around the buckle-reducing member (Col 5, lines 32-49)
Regarding claim 7, the combination of of Munsinger, Adams, and Vrba s as discussed above with regards to claim 6 teaches wherein the buckle-reducing braided member (Adams Fig 3B, metallic tubular member 40; Vrba pg 7) extends a substantial fraction of a length of the proximal member (Munsinger Fig 2, strain relief member 32, meets claimed limitation coverage).
Regarding claim 10, the combination of Munsinger, Adams, and Vrba as discussed above with regards to claim 1 teaches wherein the stent delivery system is adapted for delivering self-expanding stents (Munsinger Fig 3, stent 34 above, [0033]).
Regarding Claim 11, Munsinger discloses: A stent delivery system (Annotated Fig. 1, stent delivery system 10 above) adapted to deliver and release a self-expanding stent (Annotated Fig. 3, stent 34 above, [0004], lines 1-4) with improved force transmission efficiency within the stent delivery system ([0041], lines 11-14, Munsinger teaches using lubrication in system), the stent delivery system, comprising: an inner member (Annotated Fig. 3, inner shaft 20 above) including a stent receiving region (Annotated Fig. 3, above) adapted to accommodate a self- expanding stent therein [0034]; a proximal member extending coaxially about the inner member [0041], the proximal member (Fig. 5, outer member 50) extending proximally from near the stent receiving region (Annotated Fig. 1 above); a deployment sheath (Fig. 4, deployment sheath 16) extending coaxially about the inner member and the proximal member ([0041], “Thus, along at least a portion of the length of system 10, system 10 may include four tubular structures that may be coaxially arranged--namely outer member 50, deployment sheath 16, intermediate tube 36, and inner member 20”, Annotated Fig 1 above, elements share the same axis), the deployment sheath movable between a distal position in which the deployment sheath constrains the self-expanding stent and a proximal position in which the self-expanding stent is no longer constrained by the deployment sheath ([0041], [0042], abstract, [26], [36] slidable deployment sheath which moves from a distal position to a proximal position) the deployment sheath including a stretch-reducing braided member forming part of the deployment sheath and adapted to resist an increase in length of the deployment sheath in response to a tensile force applied to the deployment sheath during deployment of the self-expanding stent (Fig. 5, reinforcement 51; [0041]; wherein [a] buckle-reducing […] member (48) and the stretch-reducing […] member (Fig 5, 51) respectively reduce compression of the proximal member and elongation of the deployment sheath in order to improve force transmission efficiency within the stent delivery system ([0057] & [0064],Munsinger teaches using superelastic materials, as evidenced by Nargatti, see page 505 ¶ 0002 & page 521 ¶0001, superelastic materials have reduced stretchability, collapsibility and energy loss by lowering strain in system when compared to non-superelastic materials).
But Munsinger fails to disclose wherein the proximal member including buckle-reducing braided member forming part of the proximal member and adapted to resist a decrease in length of the proximal member in response to a compressive force applied to the proximal member during deployment of the self- expanding stent.
But Adams discloses a similar stent delivery system (Fig 1, catheter 10). Adams teaches wherein the proximal member (Fig 2, strain relief member 32) including buckle-reducing […] member forming part of the proximal member and adapted to resist a decrease in length of the proximal member in response to a compressive force applied to the proximal member during deployment of the self- expanding stent (Fig 1, metallic tubular member 40; Col 4, lines 23-42, Adams teaches flexibility in member, member would be capable of reducing collapsibility).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the combination of Munsinger and Adams to incorporate the proximal member including a buckle-reducing member that is adapted to reduce collapsibility within the proximal by Adams in order to provide flexibility (Adams Col 4, lines 23-42)
However, the combination of Munsinger and Adams fails to explicitly disclose wherein the buckle-reducing member is braided.
Yet, in the same field of endeavor, Vrba discloses a similar stent delivery system (Fig 1a, 110). Vrba teaches wherein the buckle-reducing member (Fig 1a, 114) is braided (pg 7, lines 17-27).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the buckle-reducing member of the buckling-reducing member as made of the combination of Munsinger and Adams to incorporate wherein the buckle-reducing member is braided, as taught and suggested by Vrba in order to maintain catheter integrity (Vrba pg 7, lines 17-27).
Regarding claim 12, the combination of Munsinger, Adam, and Vrba as discussed above with regards to claim 11, but fails to disclose an outer polymeric layer; with the stretch-reducing braided member disposed between the inner polymeric layer and the outer polymeric layer.
However, in another embodiment Adams discloses a similar stent delivery system. Adams teaches an outer polymeric layer (Adams Fig 3B, polymeric member 50) with the stretch-reducing braided member (Munsinger Fig. 5, reinforcement 51) disposed between the inner polymeric layer and the outer polymeric layer [0040].
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the combination of Munsinger, Adams and Vrba to incorporate an outer polymeric layer within the stretch-reducing member disposed between the inner polymeric layer and the outer polymeric layer as taught and suggested by Munsinger in order to provide reinforcement [0040].
Regarding claim 13, the combination of Munsinger, Adam, and Vrba as discussed above with regards to claim 12 teaches wherein the stretch-reducing braided member comprises a stainless steel (Munsinger [0058], [0056]) braid (Vrba pg 7, lines 17-27; Vrba also explicitly teaches wherein a braided member is comprised of stainless steel).
Regarding claim 14, the combination of Munsinger and Adams as discussed above with regards to claim 11 teaches wherein the buckle-reducing member (Adams Fig 3B, metallic tubular member 40) is encapsulated within a polymeric layer (Fig 3B, polymeric member 50).
Regarding claim 15, the combination of Munsinger and Adams as discussed above with regards to claim 14 teaches wherein the buckle-reducing braided (Vbra pg 7) member (Adams Fig 3B, metallic tubular member 40) extends a substantial fraction of a length of the proximal member (Adams Fig 2, strain relief member 32, meets claimed limitation coverage).
Regarding 20, the combination of Munsinger and Adams as discussed above with regards to claim 17 teaches wherein the stent delivery (Munsinger Fig 1, stent delivery system 10) is adapted for delivering peripheral stents (Munsinger [0026]; stent delivery device is capable of delivering stents in the peripheral vasculature).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munsinger in view of Tran et al. US 20180098848 A1, herein referred to as Tran, and in further view of Vrba,
Regarding claim 17, Munsinger discloses: A stent delivery system adapted to deliver and release a self-expanding stent, the stent delivery system, comprising: an inner member (Annotated Fig. 3, inner shaft 20 above) including a stent receiving region (Annotated Fig. 3, above) adapted to accommodate a self- expanding stent therein; a proximal bumper (Fig. 3, bumper 38) extending coaxially about the inner member (Fig 3, Bumper is proximal and coaxial to inner member as claimed), the proximal bumper including a buckle-reducing […] member (Fig 5, 51) encapsulated within a polymeric layer (Figs 3 and 5); and a deployment sheath (Fig. 4, deployment sheath 16) extending coaxially about the inner member and the proximal member ([0041], “Thus, along at least a portion of the length of system 10, system 10 may include four tubular structures that may be coaxially arranged--namely outer member 50, deployment sheath 16, intermediate tube 36, and inner member 20”, Annotated Fig 1 below, elements share axis, the deployment sheath including a stretch-reducing braided member (Fig. 5, reinforcement 51, [41]) disposed between an inner polymeric layer and an outer polymeric layer ([0056]), the stretch-reducing braided member (Fig. 5, reinforcement 51; [0041] teaches braiding of member [0041]) being adapted to resist an increase in length of the deployment sheath in response to a tensile force applied to the deployment sheath during deployment of the self-expanding stent the deployment sheath movable between a distal position in which the deployment sheath constrains the self-expanding stent and a proximal position ([0041], [0042], abstract, [26], [36] slidable deployment sheath which moves from a distal position to a proximal position) in which the self-expanding stent is no longer constrained by the deployment sheath ([0033], stent is biased to outwardly expand, when sheath is retracted as described from the stent receiving region stent would expand as claimed).
But Munsinger does not disclose the buckle-reducing […] member being adapted to resist a decrease in length of the proximal bumper in response to a compressive force applied to the proximal bumper during deployment of the self-expanding stent.
However, Tran discloses a similar stent delivery system (Fig 4a, 110). Tran teaches the buckle-reducing […] member (Fig 4a, 114) being adapted to resist a decrease in length of the proximal bumper (140) in response to a compressive force applied to the proximal bumper during deployment of the self-expanding stent ([0024]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify Munsinger to incorporate the buckle-reducing braided member being adapted to resist a decrease in length of the proximal bumper in response to a compressive force applied to the proximal bumper during deployment of the self-expanding stent, as taught and suggested by Adams in order to provide flexibility (Adams Col 4, lines 23-42).
However, the combination of Munsinger and Adams fails to explicitly disclose wherein the buckle-reducing member is braided.
Yet, in the same field of endeavor, Vrba discloses a similar stent delivery system (Fig 1a, 110). Vrba teaches wherein the buckle-reducing member (Fig 1a, 114) is braided (pg 7, lines 17-27).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the buckle-reducing member of the buckling-reducing member as made of the combination of Munsinger and Adams to incorporate wherein the buckle-reducing member is braided, as taught and suggested by Vrba in order to maintain catheter integrity (Vrba pg 7, lines 17-27).
Claim(s) 8-9, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munsinger in view of Adams as evidenced by Nargatti, and in further view of Vrba, and further in view of Jimenez et al WO 2007084370 A1, herein referred to as Jimenez.
Regarding claim 8, the combination of Munsinger, Adams, and Vrba as discussed above with regards to claim 6, does not explicitly disclose wherein the buckle-reducing braided (Vrba pg 7) member (Adams Fig 3B, metallic tubular member 40) is formed from a flat wire or ribbon wire.
However, in the same field of endeavor, Jimenez discloses a similar stent delivery system (Fig 1, 104). Jimenez teaches wherein the buckle-reducing braided member (Fig 1, 124) is formed from a flat wire ([0052]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the buckle-reducing braided member of Adams to incorporate where the buckle-reducing braided member is formed from a flat wire, as taught and suggested by Jimenez in order to manufacturing a layer member (Jimenez [0052]).
Regarding claim 9, the combination of Munsinger, Adams, Vrba, and Jimenez as discussed above with regards to claim 8 fails to disclose wherein the second braided member is adapted to resist buckling in response to an applied compressive force.
However, Munsinger in another embodiment discloses a similar stent delivery system including a braided member. Munsinger also teaches wherein the buckle-reducing braided member is adapted to resist buckling (Fig 4, reinforcement member 42; in response to an applied compressive force (Fig 4, reinforcement member 42, [0038], Reinforcement member 42 supports deployment sheath in applied to constrained force, i.e., compressive).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed in invention to modify the configuration of buckle- reducing braid of the combination described above to incorporate wherein the second braided member is adapted to resist buckling in response to an applied compressive force as taught and suggested by Munsinger in order to provide reinforcement [0040].
Regarding claim 16, the combination of Munsinger, Adams, and Vrba as discussed above with regards to claim 15, does not disclose wherein the buckle-reducing braided member is formed from a from flat wire or ribbon wire.
However, in the same field of endeavor, Jimenez discloses a similar stent delivery system (Fig 1, 104). Jimenez teaches wherein the buckle-reducing braided member (Fig 1, 124) is formed from a flat wire ([0052]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the buckle-reducing braided member of Adams to incorporate where the buckle-reducing braided member is formed from a flat wire, as taught and suggested by Jimenez in order to manufacture a layered member (Jimenez [0052]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Munsinger in view of Tran and Vrba, and further in view of Jimenez.
Regarding claim 18, the combination of Munsinger Tran, and Vrba as discussed above with regards to claim 17 does not disclose wherein the buckle-reducing braided member is formed from flat wire or ribbon wire.
However, in the same field of endeavor, Jimenez discloses a similar stent delivery system (Fig 1, 104). Jimenez teaches wherein the buckle-reducing braided member (Fig 1, 124) is formed from a flat wire ([0052]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the buckle-reducing braided member of Adams to incorporate where the buckle-reducing braided member is formed from a flat wire, as taught and suggested by Jimenez in order to manufacture a layered member (Jimenez [0052]).
Regarding claim 19, the combination of Munsinger, Tran, and Vrba as discussed above with regards to claim 17 does not teach wherein the stretch-reducing braided member includes axially aligned wires extending within a braid pattern of the stretch-reducing braided member.
However, in the same field of endeavor, Jimenez discloses a similar stent delivery system (Fig 1, 104). Jimenez teaches wherein the stretch-reducing braided member includes axially aligned wires extending within a braid pattern of the stretch-reducing braided member (Fig 1, 124) is formed from a flat wire ([0052]).
Therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the claimed invention to modify the stretch-reducing braided member of Adams to incorporate wherein the stretch-reducing braided member includes axially aligned wires extending within a braid pattern of the stretch-reducing braided member, as taught and suggested by Jimenez in order to manufacture a layered member (Jimenez [0052]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/A.F./Patent Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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