DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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- 13 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.
The term “significant portion” in claim 1 is a relative term which renders the claim indefinite. The term “significant portion” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2- 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 1.
The term “close proximity” in claim 1 is a relative term which renders the claim indefinite. The term “close proximity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 2- 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being dependent off claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 3- 4 and 7- 13 is/are rejected under pre-AIA 35 U.S.C. 102 (b) as being anticipated by Perez et al. (US Pat. No. 7,553,323 B1).
Regarding claim 1 in view of the rejection under 35 U.S.C. 112, second paragraph, Perez discloses a catheter assembly comprising:
a catheter having a leading end (224) (Figs. 4- 5, 7) and a trailing end (222) (Fig. 4) and comprising a main lumen extending between the leading end (224) and the trailing end (222) (See Fig. 6) (Col. 9, l. 54- 59 - - The sheath assembly 240 … is coaxially disposed over inner member 220, outer member 270 and a portion of the steering mechanism 260 at the superior portion 224 of the inner member 220; it is noted that the main lumen is considered the space over which sheath assembly 240 is disposed);
an expandable medical device (90) (Figs. 4- 5, 7) positioned at the leading end of the catheter (224);
a plurality of steering lines (260) (Fig. 4) configured to selectively bend the expandable medical device (90), the plurality of steering lines (260) positioned to traverse a surface of the expandable medical device (90) such that, across a significant portion of the expandable medical device (90), the plurality of steering lines (260) are parallel to and in close proximity with each other (Col. 9, l. 65- Col. 10, l. 11 - - The steering mechanism 260 consists of a steering ring 262, steering wires 264 and a control mechanism 266. The steering ring 262 is fixed to the superior portion 224 of the inner member 220 distal the aortic frame stop ring 226 and has eyelets 268 (See FIG. 6) spaced at equidistant locations about its circumference. The steering wires 264 are attached to the eyelets 268 and extend distally between the inner member 220 and outer member 270, exiting the wall of the inferior portion 272 of the outer member distal the inferior end 242 of the jacket assembly 240 where they are attached to the control mechanism 266. Manipulating the steering wires 264 with the control mechanism 266 causes the superior portion 224 of the flexible inner member 220 to bend, thereby allowing the repair device to be positioned properly prior to deployment; it is noted that the steering ring 262 portion of the steering mechanism 260 indirectly transverses, via outer member 270, an inner surface of the expandable medical device 90).
Regarding claim 3, Perez further discloses wherein at least a portion of the plurality of steering lines (260) extends through a portion of the main lumen (Col. 9, l. 54- 59 - - The sheath assembly 240 is similar to that described previously for the delivery system 10 illustrated in FIG. 1. The sheath assembly 240 has an inferior end 242 and superior end 244 and is coaxially disposed over inner member 220, outer member 270 and a portion of the steering mechanism 260 at the superior portion 224 of the inner member 220; it is noted that the main lumen is considered the space over which sheath assembly 240 is disposed).
Regarding claim 4, Perez further discloses wherein the plurality of steering lines (260) exit the catheter (See Fig. 4 - - showing plurality of steering lines (260) exiting at the inferior portion 272 ) and are engaged with the expandable medical device (90) near a proximal end of the expandable medical device (90) (Col. 10, l. 3- 8 - - The steering mechanism 260 consists of a steering ring 262, steering wires 264 and a control mechanism 266. The steering ring 262 is fixed to the superior portion 224 of the inner member 220 distal the aortic frame stop ring 226 and has eyelets 268 (See FIG. 6) spaced at equidistant locations about its circumference. The steering wires 264 are attached to the eyelets 268 and extend distally between the inner member 220 and outer member 270, exiting the wall of the inferior portion 272 of the outer member distal the inferior end 242 of the jacket assembly 240 where they are attached to the control mechanism 266).
Regarding claim 7, Perez further discloses wherein the plurality of steering lines (260) are operable to cause bending of at least a segment of the expandable medical device (90) when tension is applied thereto (Col. 9, l. 65- Col. 10, l. 11 - - The steering mechanism 260 consists of a steering ring 262, steering wires 264 and a control mechanism 266. The steering ring 262 is fixed to the superior portion 224 of the inner member 220 distal the aortic frame stop ring 226 and has eyelets 268 (See FIG. 6) spaced at equidistant locations about its circumference. The steering wires 264 are attached to the eyelets 268 and extend distally between the inner member 220 and outer member 270, exiting the wall of the inferior portion 272 of the outer member distal the inferior end 242 of the jacket assembly 240 where they are attached to the control mechanism 266. Manipulating the steering wires 264 with the control mechanism 266 causes the superior portion 224 of the flexible inner member 220 to bend, thereby allowing the repair device to be positioned properly prior to deployment; it is noted that the repair device is identified by reference number 90).
Regarding claim 8, Perez further discloses wherein the plurality of steering lines (260) are configured to enable selective and controllable bending of the expandable medical device (Col. 10, l. 8- 11 - - Manipulating the steering wires 264 with the control mechanism 266 causes the superior portion 224 of the flexible inner member 220 to bend, thereby allowing the repair device to be positioned properly prior to deployment; it is noted that the repair device is identified by reference number 90).
Regarding claim 9, Perez further discloses wherein the plurality of steering lines (260) engage the expandable medical device (90) in a temporary engagement of the expandable medical device (90) in relation to the catheter (Col. 10, l. 8- 11 - - Manipulating the steering wires 264 with the control mechanism 266 causes the superior portion 224 of the flexible inner member 220 to bend, thereby allowing the repair device to be positioned properly prior to deployment; it is noted that the repair device is identified by reference number 90; it is further noted that the plurality of steering lines (260) indirectly engage, via outer member 270, the expandable medical device (90) while the superior portion 224 of the flexible inner member 220 is bending).
Regarding claim 10, Perez further discloses wherein a portion of an inner surface of the expandable medical device (90) is temporarily engaged distal to the catheter (Col. 10, l. 8- 11 - - Manipulating the steering wires 264 with the control mechanism 266 causes the superior portion 224 of the flexible inner member 220 to bend, thereby allowing the repair device to be positioned properly prior to deployment; it is noted that the repair device is identified by reference number 90; it is noted that during an intermediate step of deployment, expandable medical device (90) is capable of being temporarily engaged, indirectly via outer member 270, distal to the catheter).
Regarding claim 11, Perez further discloses wherein the portion of the inner surface of the expandable medical device (90) includes a longest radius of curvature during selective and controllable bending of the expandable medical device (90) (Col. 4, l. 56- 60 - - The steering wires are attached to the most proximal steering ring and pass through holes in each of the distal steering rings. Manipulating the steering wires causes the steering rings to move in unison such that the flexible superior portion of the inner member bends smoothly along its length; it is noted that when the expandable medical device (90) is bending along it’s length it includes a longest radius of curvature).
Regarding claim 12, Perez further discloses wherein the plurality of steering lines (260) engage the expandable medical device (90) at distal and proximal ends of the expandable medical device (90) respectively along an edge of the expandable medical device (90) which is configured to exhibit the longest radius of curvature during selective and controllable bending (Col. 4, l. 56- 60 - - The steering wires are attached to the most proximal steering ring and pass through holes in each of the distal steering rings. Manipulating the steering wires causes the steering rings to move in unison such that the flexible superior portion of the inner member bends smoothly along its length; it is noted that when the expandable medical device (90) is bending along its length it is capable of exhibiting the longest radius of curvature during selective and controllable bending).
Regarding claim 13, Perez further discloses wherein, between the distal and proximal ends of the expandable medical device (90), the plurality of steering lines (260) transition toward and along an edge of the expandable medical device (90) which is configured to exhibit a shortest radius of curvature during selective and controllable bending (Col. 4, l. 56- 60 - - The steering wires are attached to the most proximal steering ring and pass through holes in each of the distal steering rings. Manipulating the steering wires causes the steering rings to move in unison such that the flexible superior portion of the inner member bends smoothly along its length; it is noted that when the expandable medical device (90) is bending along its length it is capable of exhibiting the shortest radius of curvature during selective and controllable bending).
Allowable Subject Matter
Claims 2 and 5 - 6 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claim 2, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the plurality of steering lines are woven through the surface of the expandable medical device.
Regarding claim 5, the prior art does not teach or suggest, alone or in combination with the remainder of the claim limitations, wherein the plurality of steering lines may extend across and remain substantially in contact with the surface of the expandable medical device from the proximal end to a distal end of the expandable medical device.
The closest cited prior art reference Perez et al. (US Pat. No. 7,553,323 B1) teaches a plurality of steering lines (260) (Fig. 4) configured to selectively bend the expandable medical device (90), the plurality of steering lines (260) positioned to traverse a surface of the expandable medical device (90) such that, across a significant portion of the expandable medical device (90), the plurality of steering lines (260) are parallel to and in close proximity with each other (Col. 9, l. 65- Col. 10, l. 11). Since Perez teaches shielding the expandable medical device (90) from the plurality of steering lines (260) (Col. 10, l. 47- 52), Perez does not teach or suggest, alone or in combination, wherein the plurality of steering lines are woven through the surface of the expandable medical device nor does Perez teach or suggest, alone or in combination, , wherein the plurality of steering lines may extend across and remain substantially in contact with the surface of the expandable medical device from the proximal end to a distal end of the expandable medical device.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KANKINDI RWEGO whose telephone number is (303)297-4759. The examiner can normally be reached Monday- Friday: 10:00- 5:00 MT.
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/KANKINDI RWEGO/ Primary Examiner, Art Unit 3771