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 .
Specification
The disclosure is objected to because of the following informalities: Paragraphs [0017] and [0018] use #110 to refer to both the three moveable leaves and the stent.
Appropriate correction is required.
Claim Objections
Claim 15 is objected to under 37 CFR 1.75(c) as being in improper form because it improperly depends on claim 14 by attempting to incorporate limitations from claim 11, which is not a direct or indirect parent of claim 14 . See MPEP § 608.01(n). Accordingly, the claim will be treated as best understood.
Claims 1, 2, 4-7, 9, 18, and 19 are objected to because of the following informalities:
Claim 1 recites the limitation "the apex of the stent" in line 12. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “tip of the at least one” in line 15, “the” is unnecessary.
Claim 6 recites “piercing stent of claims 5” in line 1, “claims” should be “claim”.
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 1-10, 12, and 14-20 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 1 is directed to a side-branch, piercing stent (a product), but also includes method-like language, specifically reciting that “the apical piercing tip is positioned to pierce an element positioned adjacent to the apex of the stent” in lines 11-12. This language introduces ambiguity as to whether the claim is directed to the structural configuration of the stent or the act of piercing the element (MPEP 2173.05(p)). Claims 2-10, which are dependent on claim 1, are likewise rejected.
Claim 1 recites the limitation "an element positioned adjacent to the apex " in line 13. It is unclear if this is the same “an element positioned adjacent to the apex” in line 11, or a different one. For purposes of examination, the Examiner considers them to be the same element. Claims 2-10, which are dependent on claim 1, are likewise rejected.
Claim 2 is directed to a side-branch, piercing stent (a product), but also includes method-like language, specifically reciting that “to anchor the leaves within the element and connect the side-branch, piercing stent to the element” in lines 5-6. This language introduces ambiguity as to whether the claim is directed to the structural configuration of the stent or the act of anchoring the leaves within the element and connecting the stent to the element (MPEP 2173.05(p)).
Claim 3 recites “an aneurism and/or a main stent graft introduced into the aneurism”. Using “and/or” is unclear since the element cannot be both an aneurism and a main stent graft introduced into the aneurism. For purposes of examination, the Examiner considers the element to be an aneurism or a main stent graft introduced into the aneurism.
Claim 12 recites “a rotation and/or a reversible rotation”. Using “and/or” is unclear since the movements cannot occur simultaneously. For purposes of examination, the Examiner considers the movement to be a rotation or a reversible rotation.
Claim 14 recites the limitation "at least one of the leaves" in line 3. There is insufficient antecedent basis for this limitation in the claim. Claims 15-20, which are dependent on claim 14, are likewise rejected.
Claim 15 recites, “using the side-branch stent configured according to the method of claim 11.” Attempts to claim a process without setting forth any steps involved in the process raise an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph (see MPEP 2173.05(q). The claim does not set forth any steps for how the “use” of the side branch stent is performed.
Claim 17 recites “an aneurism and/or a main stent graft introduced into the aneurism”. Using “and/or” is unclear since the element cannot be both an aneurism and a main stent graft introduced into the aneurism. For purposes of examination, the Examiner considers the element to be an aneurism or a main stent graft introduced into the aneurism.
Claim 18 recites the limitation "at least one controlling member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites the limitation "at least one controlling member" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. Claims 20, which is dependent on claim 19, is likewise rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 3 and 17 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claims 3 and 17 recite “wherein the element positioned adjacent to the apex of the stent comprises an aneurism”. Since an aneurism is a naturally occurring condition of the human vascular system, the claim is interpreted as encompassing a human organism.
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.
(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 1-5, 11-12, and 14-17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Frenklach et al. (WO 2015063780 A2).
Regarding claim 1, Frenklach discloses a side-branch, piercing stent (Fig. 9A: side branch vessel device 900) comprising: a stent body (Fig. 9A: side branch vessel device 900) having apically at least three movable leaves (Fig. 9: fingers 901; at least 2 fingers, but may be 3 or more [0075]), the leaves configured to be controllably moveable (closed configuration (Fig. 9A) [0076] and open configuration [0077] by means of fixing element 920) in a medial direction between at least two leaf states comprising (i) a closed state in which an apical stent opening is smaller than a cross section of the stent (Fig. 9A; closed configuration [0076]; when the fingers (leaves) are in a closed state, they converge such that the apical opening is smaller than the cross section of the stent), and (ii) an open state in which the apical stent opening is larger than the cross section of the stent (opened configuration [0077]; as seen in Fig. 3, when the fingers (leaves) move to the open state, they expand outwardly such that the apical opening is larger than the cross section of the stent), and at least one controlling member (Fig. 9A: fixing element 920) configured to control, mechanically and upon actuation, the movement of the leaves (Fixing element is removed which causes fingers to move to the opened configuration [0077]); wherein at least one of the leaves (Fig. 9A: fingers 901) is configured to have an apical piercing tip (Fig. 9A: sharp edges 902) that is controllably moveable (closed configuration (Fig. 9A) [0076] and open configuration [0077] by means of fixing element 920) between at least two piercing states comprising (a) an extended state in which the apical piercing tip is positioned to pierce an element positioned adjacent to the apex of the stent (Fig. 9B, when the fixing element 920 is removed, the fingers open and the sharp edges pierce the element), and (b) a contracted state in which the apical piercing tip is positioned not to pierce an element positioned adjacent to the apex of the stent (Fig. 9A; closed configuration [0076]), and wherein the at least one controlling member (Fig. 9A: fixing element 920) is further configured to control, mechanically and upon actuation, the movement (Fixing element is removed which causes fingers to move to the opened configuration [0077], thus the sharp edges also move to the open configuration) of the apical piercing tip (Fig. 9A: sharp edges 902) of the at least one of the leaves (Fig. 9A: fingers 901).
Regarding claim 2, Frenklach discloses wherein the at least one controlling member (Fig. 9A: fixing element 920) is further configured to coordinate the movement of the leaves (Fig. 9A: fingers 901) and the movement of the apical piercing tip (Fig. 9A: sharp edges 902) to enter tips of the leaves in the closed state into a hole pierced by the apical piercing tip (Sharp point (Fig. 9A: 922) is designed such that when stent graft is deployed, a fenestration is created by the sharp point (see the right hand side of Figure 9B) [0078]) and spread the tips to reach the open state of the leaves within the element positioned adjacent to the apex of the stent (Fig. 9B, when the fixing element 920 is removed, the fingers open) —to anchor the leaves within the element and connect the side-branch, piercing stent to the element (Fig. 9B, when the fixing element 920 is removed, the fingers open and the sharp edges pierce the element)—providing fluid communication therebetween (by the fingers being in an open configuration, this will provide fluid communication between the element and the side branch).
Regarding claim 3, Frenklach discloses wherein the element positioned adjacent to the apex of the stent (Fig. 9B) comprises an aneurism (to treat an aneurysm [0053]) and/or a main stent graft introduced into the aneurism (Fig. 9B: stent graft 210).
Regarding claim 4, Frenklach discloses wherein the at least one controlling member (Fig. 9A: fixing element 920) comprises at least one string (a fixing element, such as a wire, twine, string, tube, or any other appropriate means [0065]) that is associated with the leaves and the apical piercing tip to control their movement (Fig. 9A; fixing element is removed which causes fingers to move to the opened configuration [0077]).
Regarding claim 5, Frenklach discloses wherein the at least one controlling member (Fig. 9A: fixing element 920) is configured to rotate the apical piercing tip from the contracted state to the extended state thereof (Fig. 9A; fixing element is removed which causes fingers (which have sharp edges 902) to move to the opened configuration [0077]).
Regarding claim 11, Frenklach discloses a method of configuring a side-branch stent (Fig. 9A: side branch vessel device 900) for attachment to an element positioned adjacent to the apex of the side-branch stent (Fig. 9b: stent graft 210), the method comprising: configuring the side-branch stent body (Fig. 9A: side branch vessel device 900) to have apically at least three movable leaves (Fig. 9: fingers 901; at least 2 fingers, but may be 3 or more [0075]), the leaves configured to be controllably moveable (closed configuration (Fig. 9A) [0076] and open configuration [0077] by means of fixing element 920) in a medial direction between at least two leaf states comprising (i) a closed state in which an apical stent opening is smaller than a cross section of the stent (Fig. 9A; closed configuration [0076]; when the fingers (leaves) are in a closed state, they converge such that the apical opening is smaller than the cross section of the stent), and (ii) an open state in which the apical stent opening is larger than the cross section of the stent (opened configuration [0077]; as seen in Fig. 3, when the fingers (leaves) move to the open state, they expand outwardly such that the apical opening is larger than the cross section of the stent), configuring at least one of the leaves (Fig. 9A: fingers 901) to have an apical piercing tip (Fig. 9A: sharp edges 902) that is controllably moveable (closed configuration (Fig. 9A) [0076] and open configuration [0077] by means of fixing element 920) between at least two piercing states comprising (a) an extended state in which the apical piercing tip is positioned to pierce the element positioned adjacent to the apex of the stent (Fig. 9B, when the fixing element 920 is removed, the fingers open and the sharp edges pierce the element), and (b) a contracted state in which the apical piercing tip is positioned not to pierce the element positioned adjacent to the apex of the stent (Fig. 9A; closed configuration [0076]), and associating with the leaves (Fig. 9A: fingers 901) at least one controlling member (Fig. 9A: fixing element 920) configured to control, mechanically and upon actuation, the movement of the leaves and the movement of the apical piercing tip of the at least one of the leaves (Fixing element is removed which causes fingers to move to the opened configuration [0077], thus the sharp edges also move to the open configuration).
Regarding claim 12, Frenklach discloses further comprising coordinating the movement of the leaves (Fig. 9A: fingers 901) and the movement of the apical piercing tip (Fig. 9A: sharp edges 902) to enter tips of the leaves in the closed state into a hole pierced by the apical piercing tip (Sharp point (Fig. 9A: 922) is designed such that when stent graft is deployed, a fenestration is created by the sharp point (see the right hand side of Figure 9B) [0078]) and spread the tips to reach the open state of the leaves within the element positioned adjacent to the apex of the stent (Fig. 9B, when the fixing element 920 is removed, the fingers open)—to anchor the leaves within the element and connect the side-branch, piercing stent to the element (Fig. 9B, when the fixing element 920 is removed, the fingers open and the sharp edges pierce the element)—providing fluid communication therebetween (by the fingers being in an open configuration, this will provide fluid communication between the element and the side branch).
Regarding claim 14, Frenklach discloses a method of attaching a side-branch stent (Fig. 9A: side branch vessel device 900) to an element positioned adjacent to the apex of the side-branch stent (Fig. 9b: stent graft 210), the method comprising: moving, controllably, an apical piercing tip (Fig. 9A: sharp edges 902) of at least one of the leaves into (a) an extended state in which the apical piercing tip is positioned to pierce the element positioned adjacent to the apex of the stent (Fig. 9B, when the fixing element 920 is removed, the fingers open and the sharp edges pierce the element), and moving, controllably, at least three apical movable leaves (Fig. 9: fingers 901; at least 2 fingers, but may be 3 or more [0075]) in a medial direction from (i) a closed state in which an apical stent opening is smaller than a cross section of the stent (Fig. 9A; closed configuration [0076]; when the fingers (leaves) are in a closed state, they converge such that the apical opening is smaller than the cross section of the stent) into (ii) an open state in which the apical stent opening is larger than the cross section of the stent (opened configuration [0077]; as seen in Fig. 3, when the fingers (leaves) move to the open state, they expand outwardly such that the apical opening is larger than the cross section of the stent).
Regarding claim 15, as best understood, Frenklach discloses further comprising using the side-branch stent (Fig. 9A: side branch vessel device 900) configured according to the method of claim 11 (abstract).
Regarding claim 16, Frenklach discloses further comprising coordinating the movement of the leaves (Fig. 9A: fingers 901) and the movement of the apical piercing tip (Fig. 9A: sharp edges 902) to enter tips of the leaves in the closed state into a hole pierced by the apical piercing tip (Sharp point (Fig. 9A: 922) is designed such that when stent graft is deployed, a fenestration is created by the sharp point (see the right hand side of Figure 9B) [0078])and spread the tips to reach the open state of the leaves within the element positioned adjacent to the apex of the stent (Fig. 9B, when the fixing element 920 is removed, the fingers open)—to anchor the leaves within the element and connect the side-branch, piercing stent to the element (Fig. 9B, when the fixing element 920 is removed, the fingers open and the sharp edges pierce the element)—providing fluid communication therebetween (by the fingers being in an open configuration, this will provide fluid communication between the element and the side branch).
Regarding claim 17, Frenklach discloses wherein the element positioned adjacent to the apex of the stent (Fig. 9B) comprises an aneurism (to treat an aneurysm [0053]) and/or a main stent graft introduced into the aneurism (Fig. 9B: stent graft 210).
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.
Claims 6, 9-10, 13, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Frenklach et al. (WO 2015063780 A2) in view of Haug et al. (US 20050283231 A1).
Regarding claim 6, Frenklach does not expressly disclose wherein the at least one controlling member is configured to carry out the rotation in a reversible manner.
Haug teaches a heart replacement valve and wherein the at least one controlling member (Fig. 17A: release wires 314B) is configured to carry out the rotation in a reversible manner (user may pull on release wires (314B), thereby reversing orientation of tabs [0104]).
Haug teaches that this will allow for repositioning of the device [0104].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent disclosed by Frenklach to incorporate the at least one controlling member is configured to carry out the rotation in a reversible manner, as taught by Haug. Doing so would allow for repositioning of the device, as taught by Haug.
Regarding claim 9, Frenklach does not expressly disclose wherein the at least one controlling member comprises two strings comprising a first string configured to rotate the apical piercing tip from the contracted state to the extended state thereof, and a second string configured to move the leaves from the closed state to the open state thereof
Haug teaches a heart replacement valve with a control mechanism and wherein the at least one controlling member (Fig. 3B: delivery system 100) comprises two strings (Fig. 3b: control wires 50, 62) comprising a first string (Fig. 3B: control wire 50) configured to rotate the apical piercing tip (Fig. 3B: lip region 32; [0124] states that the lip region engages the patient’s native valve leaflets to achieve positive registration, so it can be expanded first to seat and secure the anchor, functioning like a piercing tip that toggles into position to grip tissue ) from the contracted state to the extended state thereof (expansion and contraction of the lip region [0075]), and a second string (Fig. 3B: control wire 62) configured to move the leaves (Fig. 3B: skirt region 34; [0122] states that the skirt region is expanded or locked in a second step to further stabilize and seal the device, functioning like leaves that open from a smaller, closed arrangement into a fully deployed state) from the closed state to the open state thereof (expansion and contraction of the skirt region [0075]).
Haug teaches that by having two control wires, the expansion and contraction of the regions may be independently controlled [0075].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent disclosed by Frenklach to incorporate two control wires, as taught by Haug. Doing so would allow the expansion and contraction of the regions to be independently controlled, as taught by Haug.
Regarding claim 10, Frenklach does not expressly disclose wherein both strings are manipulated by pulling out and releasing the respective strings.
Haug teaches a heart replacement valve with a control mechanism and wherein both strings (Fig. 3B: control wires 50, 62) are manipulated by pulling out and releasing the respective strings (wires 50 and 62 may be removed from apparatus [0074]).
Haug teaches that by removing the wires, this separates the delivery system from the apparatus [0074].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent disclosed by Frenklach to incorporate where both strings are manipulated by pulling out and releasing the strings, as taught by Haug. Doing so would remove the delivery system from the apparatus, as taught by Haug.
Regarding claim 13, Frenklach discloses wherein the movement of the apical piercing tip (Fig. 9A: sharp edges 902) comprises a rotation (Fig. 9B, when the fixing element 920 is removed, the fingers open and the sharp edges pierce the element).
However, Frenklach does not expressly disclose the movement comprises a reversible rotation thereof.
Haug teaches a heart replacement valve with release wires and a reversible rotation thereof (user may pull on release wires (314B), thereby reversing orientation of tabs [0104]).
Haug teaches that this will allow for repositioning of the device [0104].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent disclosed by Frenklach to incorporate the at least one controlling member is configured to carry out the rotation in a reversible manner, as taught by Haug. Doing so would allow for repositioning of the device, as taught by Haug.
Regarding claim 19, Frenklach does not expressly disclose wherein the at least one controlling member comprises two strings, and wherein the method further comprises using a first string to rotate the apical piercing tip from the contracted state to the extended state thereof, and using a second string to move the leaves from the closed state to the open state thereof
Haug teaches a heart replacement valve with a control mechanism and wherein the at least one controlling member (Fig. 3B: delivery system 100) comprises two strings (Fig. 3b: control wires 50, 62), and wherein the method further comprises using a first string (Fig. 3B: control wire 50) to rotate the apical piercing tip (Fig. 3B: lip region 32; [0124] states that the lip region engages the patient’s native valve leaflets to achieve positive registration, so it can be expanded first to seat and secure the anchor, functioning like a piercing tip that toggles into position to grip tissue) from the contracted state to the extended state (expansion and contraction of the lip region [0075]) thereof, and using a second string (Fig. 3B: control wire 62) to move the leaves (Fig. 3B: skirt region 34; [0122] states that the skirt region is expanded or locked in a second step to further stabilize and seal the device, functioning like leaves that open from a smaller, closed arrangement into a fully deployed state) from the closed state to the open state thereof (expansion and contraction of the skirt region [0075]).
Haug teaches that by having two control wires, the expansion and contraction of the regions may be independently controlled [0075].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent disclosed by Frenklach to incorporate two control wires, as taught by Haug. Doing so would allow the expansion and contraction of the regions to be independently controlled, as taught by Haug.
Regarding claim 20, Frenklach does not expressly disclose wherein both strings are manipulated by pulling out and releasing the respective strings.
Haug teaches a heart replacement valve with a control mechanism and wherein both strings (Fig. 3B: control wires 50, 62) are manipulated by pulling out and releasing the respective strings (wires 50 and 62 may be removed from apparatus [0074]).
Haug teaches that by removing the wires, this separates the delivery system from the apparatus [0074].
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the stent disclosed by Frenklach to incorporate where both strings are manipulated by pulling out and releasing the strings, as taught by Haug. Doing so would remove the delivery system from the apparatus, as taught by Haug.
Claims 7-8, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Frenklach et al. (WO 2015063780 A2) in view of Pelton (US 6468298 B1).
Regarding claim 7, Frenklach discloses wherein the at least one controlling member (Fig. 9A: fixing element 920) comprises a single string (a fixing element, such as a wire, twine, string, tube, or any other appropriate means [0065]).
However, Frenklach does not expressly disclose that the single string is configured to rotate the apical piercing tip from the contracted state to the extended state thereof upon initial manipulation, and to move the leaves from the closed state to the open state thereof upon consecutive manipulation of the string.
Pelton teaches a gripping delivery system for self-expanding stents with a method of decoupling and wherein the at least one controlling member (Fig. 3: control wires 64) comprises a single string (Fig. 3: control wire 64; even though it uses plural control wire, they can become a single control wire as Col. 6, lines 54-57 states that the control wires (64) may be twisted together to project proximally through a control wire lumen) configured to rotate the apical piercing tip (Fig. 3: hooks 56; the hooks engage the stent struts to hold or release them (Col. 6, lines 59-65), functioning like a piercing tip that toggles between a contracted and extended state) from the contracted state to the extended state thereof upon initial manipulation (pushing the control wires distally to rotate the free extremity of the grippers counter clockwise to help release the hooks from the struts of the stent (Col. 8, lines 54-57)), and to move the leaves (Fig. 3: grippers 26; the grippers pivot from a closed, contracted position to an outwardly open position (Col. 8, lines 28-36, 41-45), functioning like the leaves that expand to secure or free the stent) from the closed state to the open state (shiftable between the respective radially outwardly deployed position (shown in FIG. 3) and a contracted position (Col. 5, lines 3-9)) thereof upon consecutive manipulation of the string (push and pull the sliding actuating rails to deploy and contract the grippers (Col 6. lines 62-65).
It would have been prima facie obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modified the stent disclosed by Frenklach to incorporate a single string for the movement, as taught by Pelton, as use of a known technique of using a single string for movement and decoupling to improve a similar devices in the same way (MPEP 2143). The modified Frenklach and Pelton combination has the same function as the claimed invention and is a known technique that can improve a similar device in the same way.
Regarding claim 8, Frenklach does not expressly disclose wherein the initial manipulation comprises pulling and releasing the string and the consecutive manipulation comprises pulling and removing the string.
Pelton teaches a gripping delivery system for self-expanding stents with a method of decoupling and wherein the initial manipulation comprises pulling and releasing the string (the control wire can be pushed and pulled (Col. 6, lines 62-64)) and the consecutive manipulation comprises pulling and removing the string (the control wire can be pushed and pulled (Col. 6, lines 62-64); after the stent has been adjusted, the entire stent delivery system may be then withdrawn from the patient's vasculature (Col 8, lines 65-67)).
Pelton teaches that the radially outwardly deployment of the grippers from their contracted position around the compressed stent allows the stent to gradually expand within the vessel lumen with the radially outwardly rotation of the grippers can be achieved at a carefully controlled rate (Col. 8, lines 41-46), which inherently means the control wires enable a controlled, gradual expansion of the stent.
It would have been prima facie obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modified the stent disclosed by Frenklach to incorporate the manipulation of the string, as taught by Pelton. Doing so would allow for a controlled, gradual expansion of the stent, as taught by Pelton.
Regarding claim 18, Frenklach discloses wherein the at least one controlling member (Fig. 9A: fixing element 920) comprises a single string (a fixing element, such as a wire, twine, string, tube, or any other appropriate means [0065]).
However, Frenklach does not expressly disclose wherein the method further comprises using the single string to rotate the apical piercing tip from the contracted state to the extended state thereof by pulling and releasing the string, and to move the leaves from the closed state to the open state thereof by pulling and removing the string.
Pelton teaches a gripping delivery system for self-expanding stents with a method of decoupling and wherein the method further comprises using the single string (Fig. 3: control wire 64; even though it uses plural control wire, they can become a single control wire as Col. 6, lines 54-57 states that the control wires (64) may be twisted together to project proximally through a control wire lumen) to rotate the apical piercing tip (Fig. 3: hooks 56; the hooks engage the stent struts to hold or release them (Col. 6, lines 59-65), functioning like a piercing tip that toggles between a contracted and extended state) from the contracted state to the extended state thereof by pulling and releasing the string (the control wire can be pushed and pulled (Col. 6, lines 62-64); pushing the control wires distally to rotate the free extremity of the grippers counter clockwise to help release the hooks from the struts of the stent (Col. 8, lines 54-57)), and to move the leaves (Fig. 3: grippers 26; the grippers pivot from a closed, contracted position to an outwardly open position (Col. 8, lines 28-36, 41-45), functioning like the leaves that expand to secure or free the stent) from the closed state to the open state (shiftable between the respective radially outwardly deployed position (shown in FIG. 3) and a contracted position (Col. 5, lines 3-9) thereof by pulling and removing the string (the control wire can be pushed and pulled (Col. 6, lines 62-64); after the stent has been adjusted, the entire stent delivery system may be then withdrawn from the patient's vasculature (Col 8, lines 65-67)).
It would have been prima facie obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modified the stent disclosed by Frenklach to incorporate a single string and the manipulation of the string, as taught by Pelton, as use of a known technique of using a single string for movement and decoupling to improve a similar devices in the same way (MPEP 2143). The modified Frenklach and Pelton combination has the same function as the claimed invention and is a known technique that can improve a similar device in the same way.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Savannah J. Herring whose telephone number is (571)272-1559. The examiner can normally be reached Monday-Friday 8:00-4:00 EST.
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/Savannah J. Herring/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774