DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 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.
Claim 1 [and dependent claims 2-10] and claim 11 [and dependent claims 12-20] 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 recites: “an elongated shaft having a proximal end a distal end.” This phrase is indefinite because it is missing the conjunction “and” between “proximal end” and “a distal end,” rendering the metes and bounds of the claimed element unclear.
Additionally, claim 1 recites: “a sheath configured to retain the stent and the cover is a radially collapsed state.” This phrase contains a typographical error in which “is” should read “in,” making the intended meaning of the claim unclear.
Claim 11 recites: “an elongated shaft having a proximal end a distal end.” This phrase is indefinite because it is missing the conjunction “and” between “proximal end” and “a distal end,” rendering the metes and bounds of the claimed element unclear.
Additionally, claim 11 recites: “a sheath configured to retain the stent and the cover is a radially collapsed state.” This phrase contains a typographical error in which “is” should read “in,” making the intended meaning of the claim unclear.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-7 and 9-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kluck (US 2012/0101560A1) in view of Solem (US 6,395,212B1).
Independent claim 1 recites a medical assembly comprising:
a perfusion device comprising:
a self-expandable stent comprising a generally cylindrical distal end portion and a tapered, conical proximal end portion extending from the distal end portion, wherein the proximal end portion has a first diameter where it is connected to the distal end portion of the stent and tapers in a proximal direction to a second, smaller diameter at a proximal end of the stent;
a blood-impermeable cover extending at least partially over the distal end portion and the proximal end portion of the stent; and
an elongated shaft having a proximal end [and] a distal end, wherein the distal end of the shaft is fixedly secured to the proximal end of the stent; and
a sheath configured to retain the stent and the cover in a radially collapsed state for insertion into a vessel of a patient, wherein the stent and the cover are expandable from the radially collapsed state to a radially expanded, deployed state within the vessel when deployed from the sheath.
In relation to independent claim 1, Kluck discloses a retractable flow maintaining stent wire comprising a self-expanding stent (14) having a cylindrical, fully expandable section (26) and a conical partially expandable section (24). As stated in paragraph [0037]: “The micro-stent 14 is constructed in two sections; a cylindrical, fully expandable section 26 and a conical partially expandable section 24.” The proximal end (18) of the stent is configured as an expanding conical section (24) emanating forward from the connection point (22) with the guide wire to the fully expanding section (26) that extends along the remainder of the stent to its distal end (20), as disclosed in paragraph [0034]: “The micro-stent 14 has a proximal end 18 and a distal end portion 20. The proximal end of the stent 14 is configured as an expanding conical section 24 emanating forward from the connection point 22 with the guide wire 12 to the fully expanding section 26 that extends along the remainder of the stent 14 to its distal end 20.” The conical section (24) tapers from a first diameter at its distal end (where it connects to the cylindrical section 26) to a second, smaller diameter at the proximal end (18) of the stent. Kluck further discloses an elongated shaft (hollow shaft 16) having a proximal end and a distal end, wherein the distal end of the shaft is connected to the proximal end of the stent via the guide wire (12), as disclosed in paragraph [0032]: “Mounted through the main port 32 is a guide wire 12 that exits through the manifold 30 and through the hollow shaft 16. At the distal end of the shaft 16 the guide wire 12 can exit the shaft 16. Mounted to the distal end of the stent wire 12 is a self-expanding stent 14.” Kluck further discloses a sheath (16) configured to retain the stent in a radially collapsed state for insertion into a vessel of a patient, as disclosed in paragraph [0036]: “The sheath 16 maintains the constrained micro-stent 14 in its retracted, collapsed state at or near its distal end.” The stent is expandable from the radially collapsed state to a radially expanded, deployed state within the vessel when deployed from the sheath, as disclosed in paragraph [0037].
Kluck does not explicitly disclose a blood-impermeable cover extending at least partially over the distal end portion and the proximal end portion of the stent. However, Solem discloses a covered stent comprising a stent (1) and a tube (2) of a film material (e.g., PTFE or FEP) that is blood-impermeable and extends over the stent. As stated in the specification, col. 2, lines 39-41: “Fluorinated ethylene-propylene (FEP) and polytetrafluoroethylene (PTFE) have the characteristic that they will shrink when they are exposed to high temperatures.” The tube is introduced over the stent and shrunk to affix the stent within the tube, providing a blood-impermeable cover extending over the stent.
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the stent of Kluck to include a blood-impermeable cover as
taught by Solem. The motivation to combine is provided by Solem, which teaches that covering a stent with a blood-impermeable material serves to close holes or cover damage of the inner layer of the vessel, as stated in the specification, col. 1, lines 16-18: “In these cases of vessel lesions and perforations a cover on the metal stents may close the hole or cover the damage of the inner layer of the vessel, called intima.” One of ordinary skill in the art would have been motivated to combine the teachings of Kluck and Solem to provide a covered stent with the conical/cylindrical geometry of Kluck and the blood impermeable cover of Solem, with a reasonable expectation of success.
Independent claim 11 recites a medical assembly comprising:
a perfusion device comprising:
a self-expandable stent comprising a proximal end portion and a distal end portion extending from a distal end of the proximal end portion, wherein the proximal end portion tapers from the distal end of the proximal end portion to a proximal end of the proximal end portion;
a blood-impermeable cover extending at least partially over the distal end portion and the proximal end portion of the stent; and
an elongated shaft having a proximal end [and] a distal end, wherein the distal end of the shaft is fixedly secured to the proximal end of the proximal end portion of the stent; and
a sheath configured to retain the stent and the cover in a radially collapsed state for insertion into a vessel of a patient, wherein the stent and the cover are expandable from the radially collapsed state to a radially expanded, deployed state within the vessel when deployed from the sheath.
In relation to independent claim 11, as discussed above, Kluck discloses a medical assembly comprising: a perfusion device comprising: a self-expandable stent (14) comprising a proximal end portion (conical section 24) and a distal end portion (cylindrical section 26) extending from a distal end of the proximal end portion, wherein the proximal end portion tapers from the distal end of the proximal end portion to a proximal end of the proximal end portion (see paragraphs [0033], [0034], [0037]). Kluck further discloses an elongated shaft (hollow shaft 16) having a proximal end and a distal end, wherein the distal end of the shaft is connected to the proximal end of the proximal end portion of the stent via the guide wire (12), as disclosed in paragraph [0034]: “The guide wire 12 is manipulable within the shaft 16 and connects the stent 14 upward through the hollow shaft 16 to the control apparatus 28.” The connection point (22) is at the proximal end (18) of the stent, as disclosed in paragraph [0037]: “The guide wire 12 is connected at the proximal end 18 of the stent 14 at the connection point 22.” Kluck further discloses a sheath (16) configured to retain the stent in a radially collapsed state for insertion into a vessel of a patient, as disclosed in paragraph [0036]: “The sheath 16 maintains the constrained micro-stent 14 in its retracted, collapsed state at or near its distal end.”
Kluck does not explicitly disclose a blood-impermeable cover extending at least partially over the distal end portion and the proximal end portion of the stent. However, Solem discloses a covered stent comprising a stent (1) and a tube (2) of a film material (e.g., PTFE or FEP) that is blood-impermeable and extends over the stent. As stated in the specification, col. 2, lines 39-41: “Fluorinated ethylene-propylene (FEP) and polytetrafluoroethylene (PTFE) have the characteristic that they will shrink when they are exposed to high temperatures.” The tube is introduced over the stent and shrunk to affix the stent within the tube, providing a blood-impermeable cover extending over the stent.
Based on the above comments, it would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the stent of Kluck to include a blood-impermeable cover as taught by Solem. The motivation to combine is provided by Solem, which teaches that covering a stent with a blood-impermeable material serves to close holes or cover damage of the inner layer of the vessel, as stated in the specification, col. 1, lines 16-18: “In these cases of vessel lesions and perforations a cover on the metal stents may close the hole or cover the damage of the inner layer of the vessel, called intima.” One of ordinary skill in the art would have been motivated to combine the teachings of Kluck and Solem to provide a covered stent with the conical/cylindrical geometry of Kluck and the blood impermeable cover of Solem, with a reasonable expectation of success.
In relation to claim 2, the combination of Kluck in view of Solem discloses all the elements of this this claim. Kluck discloses a hand-manipulable control apparatus (28) connected to the proximal end of the shaft (hollow shaft 16), as disclosed in paragraph [0032]: “Mounted to the distal end of the stent wire 12 is a self-expanding stent 14 of the present invention that can be delivered, using the apparatus described, to the affected site within the human body. The stent 14 is manipulable into and out of the shaft 16 with the use of the guide wire 12 and hand-manipulable control apparatus 28 located above the main port 32.” This corresponds to a handle connected to the proximal end of the shaft. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 3, the combination of Kluck in view of Solem discloses all the elements of this claim. Solem discloses that the tube (2) of film material extends over the stent (1) along the
entire length of the stent, as disclosed in the specification, col. 3, lines 24-27: “As illustrated in FIG. 3, the stent 1 is introduced into the tube 2 and, when fully positioned within the tube 2, as shown in FIG. 4, the temperature of the tube 2 is elevated such that shrinkage thereof is initiated.” Accordingly, it would have been obvious to apply the cover of Solem over the entire length of the conical proximal end portion of the stent of Kluck to ensure complete coverage of the vessel defect, as taught by Solem.
In relation to claim 4, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the stent (14) is composed of an interlaced wire mesh material, as disclosed in paragraph [0037]: “The micro-stent 14 is composed of a metallic or polymeric mesh material to allow flow of the bodily fluids through the expanded stent 14 without substantial blockage or interference in fluid flow.” Additionally, paragraph [0037] states: “Both sections 24, 26 are constructed of an interlaced wire mesh reinforced along the longitudinal direction for strength.” This corresponds to a plurality of wires forming a plurality of longitudinally extending loops arranged in a
circumferential direction of the stent. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 5, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses an interlaced wire mesh in which the wires are interconnected, as disclosed in paragraph [0037]: “Both sections 24, 26 are constructed of an interlaced wire mesh reinforced along the longitudinal direction for strength.” The interlaced nature of the mesh implies that each loop is connected to adjacent loops at adjacent sides. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 6, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the stent (14) is composed of a metallic mesh material, as disclosed in paragraph [0037]: “The micro-stent 14 is composed of a metallic or polymeric mesh material.” Nitinol is a well-known self-expanding metallic stent material. Solem further confirms that Nitinol (memory metal) is a standard self-expanding stent material, as disclosed in the specification, col. 2, lines 52-54: “The covered stent may also be supplied with internal stents, preferably made of a memory metal (e.g. Nitinol) self-expanding material.” Accordingly, it would have been obvious to one of ordinary skill in the art to use Nitinol for the wires of Kluck, as Nitinol is a standard material for self-expanding stents.
In relation to claim 7, the combination of Kluck in view of Solem discloses all the elements of this claim. As discussed above, Solem discloses that the cover (tube 2) is made of a film material such as PTFE or FEP, which is a type of fabric/film material used in stent grafts. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 9, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the conical proximal section (24) of the stent is shaped to allow the stent to be recaptured back into the sheath after deployment, as disclosed in paragraph [0038]: “The first to contact the sheath 16 upon retracting is the conical section 24 that is caused to collapse as it is pulled into the sheath 16. As the conical section 24 is reduced in its overall diameter with such diametric reduction extending to and along the joint with the cylindrical section 26, the cylindrical section 26 follows the contraction of the conical section 24 and contracts to its original restrained dimensions for fitting within the sheath 16.” Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 10, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the proximal end portion of the stent has a substantially conical form, as disclosed in paragraph [0033]: “The stent portion or micro-stent 14 has the particular geometry and cross-wire configuration dependent upon the area of use within the human body, that is capable of full expansion only along a pre-determined length of its body with the remainder of the overall length tapering in substantially conical form to a fixed connection point 22 to connect with the guide wire 12.” A substantially conical form implies a constant taper from the first diameter to the second diameter. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 12, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses a hand-manipulable control apparatus (28) connected to the proximal
end of the shaft (hollow shaft 16), as disclosed in paragraph [0032]: “The stent 14 is manipulable into and out of the shaft 16 with the use of the guide wire 12 and hand manipulable control apparatus 28 located above the main port 32.” This corresponds to a handle connected to the proximal end of the shaft. Accordingly, in view of the demonstrated conventionality of this enhancement, its
implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 13, the combination of Kluck in view of Solem discloses all the elements of this claim. Solem discloses that the tube (2) of film material extends over the stent (1) along the
entire length of the stent, as disclosed in the specification, col. 3, lines 24-27: “As illustrated in FIG. 3, the stent 1 is introduced into the tube 2 and, when fully positioned within the tube 2, as shown in FIG. 4, the temperature of the tube 2 is elevated such that shrinkage thereof is initiated.” Accordingly, it would have been obvious to apply the cover of Solem over the entire length of the proximal end portion of the stent of Kluck to ensure complete coverage of the vessel defect.
In relation to claim 14, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the stent (14) is composed of an interlaced wire mesh material, as
disclosed in paragraph [0037]: “Both sections 24, 26 are constructed of an interlaced wire mesh reinforced along the longitudinal direction for strength.” This corresponds to a plurality of wires forming a plurality of longitudinally extending loops arranged in a circumferential direction of the stent.
Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 15, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses an interlaced wire mesh in which the wires are interconnected, as disclosed in paragraph [0037]: “Both sections 24, 26 are constructed of an interlaced wire mesh reinforced along the longitudinal direction for strength.” The interlaced nature of the mesh implies that each loop is connected to adjacent loops at adjacent sides. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 16, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the stent (14) is composed of a metallic mesh material, as disclosed in paragraph [0037]: “The micro-stent 14 is composed of a metallic or polymeric mesh material.” Solem confirms that Nitinol (memory metal) is a standard self-expanding stent material, as disclosed in the specification, col. 2, lines 52-54: “The covered stent may also be supplied with internal stents, preferably made of a memory metal (e.g. Nitinol) self-expanding material.” Accordingly, it would have been obvious to one of ordinary skill in the art to use Nitinol for the wires of Kluck, as Nitinol is a standard material for self-expanding stents.
In relation to claim 17, the combination of Kluck in view of Solem discloses all the elements of this claim. Solem discloses that the cover (tube 2) is made of a film material such as PTFE or FEP,
which is a type of fabric/film material used in stent grafts. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 18, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the proximal end portion (conical section 24) of the stent has a conical shape that tapers from a first diameter at the distal end of the proximal end portion (where it connects to the cylindrical section 26) to a second, smaller diameter at the proximal end (18) of the stent, as disclosed in paragraph [0033]: “The stent portion or micro-stent 14 has the particular geometry and cross-wire configuration dependent upon the area of use within the human body, that is capable of full expansion only along a pre-determined length of its body with the remainder of the overall length tapering in substantially conical form to a fixed connection point 22 to connect with the guide wire 12.” The connection point (22) is at the proximal end (18) of the stent, which has a smaller diameter than the distal end of the conical section. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 19, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the conical proximal section (24) of the stent is shaped to allow
the stent to be recaptured back into the sheath after deployment, as disclosed in paragraph [0038]: “The first to contact the sheath 16 upon retracting is the conical section 24 that is caused to collapse as it is pulled into the sheath 16. As the conical section 24 is reduced in its overall diameter with such diametric reduction extending to and along the joint with the cylindrical section 26, the cylindrical section 26 follows the contraction of the conical section 24 and contracts to its original restrained
dimensions for fitting within the sheath 16.” Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
In relation to claim 20, the combination of Kluck in view of Solem discloses all the elements of this claim. Kluck discloses that the proximal end portion of the stent has a substantially conical form, as disclosed in paragraph [0033]: “…with the remainder of the overall length tapering in substantially conical form to a fixed connection point 22 to connect with the guide wire 12.” A substantially conical form implies a constant taper from the first diameter to the second diameter. Accordingly, in view of the demonstrated conventionality of this enhancement, its implementation in the invention would have been considered an obvious alternative in the design of the medical assembly.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kluck (US 2012/0101560A1) in view of Solem (US 6,395,212B1), as discussed above, and in further view of Banas (US 2006/0052865A1).
In relation to claim 8, Kluck and Solem do not explicitly disclose a cover comprising a metal film. However, Banas discloses stents with metallic covers, as disclosed in paragraph [0008]: “It is, therefore, a principal objective of the present invention to provide a stent-graft type device fabricated entirely of biocompatible metals and/or pseudometallic materials.” Banas further discloses: “The structural support component and the covering component are preferably fabricated entirely of self-supporting films made of biocompatible metals or biocompatible pseudometals.” (paragraph [0033]).
Based on the above comments, it would have been obvious to one of ordinary skill in the art to use a metal film as the cover material, as taught by Banas, to provide a device fabricated entirely of biocompatible metals to improve endothelialization and healing response, as stated in paragraph [0020] of Banas: “The inventive stent-graft type device of the present invention is formed entirely of metal or pseudometallic material that exhibits improved endothelialization and healing response as compared to that associated with using conventional synthetic polymeric graft materials.”
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783