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 § 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.
Claims 1-11 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens at al. (US 5,584,803) in view of Greenberg (US 2008/0039881).
Regarding claim 1 and 20, Stevens discloses a valve leaflet resection device comprising: a catheter (fig.5; catheter 10); an electrode assembly (tissue cutter 65) slidably disposed within the catheter and deployable from the catheter and configured to remove a portion of a leaflet of a heart valve [0052]; a leaflet retainer (forceps 71) slidably disposed within the catheter and deployable from the catheter (fig.5, see also col. 25, line 52 – col.26, line 24), the leaflet retainer configured to grasp a leaflet of a heart valve (col. 25, line 52 – col.26, line 24), However, Stevens does not disclose a capture basket configured to capture a resected portion of the leaflet of the heart valve upon retraction of the leaflet retainer.
Greenberg discloses a valve leaflet resection device comprising: a catheter (an apparatus 104); cutting means (216) slidably disposed within the catheter and deployable from the catheter and configured to remove a portion of a leaflet of a heart valve [0052]; a leaflet retainer (strut members 232) slidably disposed within the catheter and deployable from the catheter [0036], the leaflet retainer (one or more retainers coupled with a catheter slidably within first catheter assembly 210) configured to grasp a leaflet of a heart valve [0062]; and a capture basket (filter basket 224) configured to capture a resected portion of the leaflet of the heart valve upon retraction of the leaflet retainer [0067]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Stevens with a capture basket configured to capture a resected portion of the leaflet of the heart valve upon retraction of the leaflet retainer as taught by Greenberg for the purpose of removing the waste safely from the body.
Regarding claim 2, Stevens/Greenberg teaches the valve leaflet resection device of claim 1, wherein the capture basket includes a radially compressed configuration and a radially expanded configuration ([0057] of Greenberg).
Regarding claim 3, Stevens/Greenberg teaches the valve leaflet resection device of claim 1, wherein the capture basket is disposed co-axially around the leaflet retainer (fig.2 of Greenberg).
Regarding claim 4, Greenberg discloses the valve leaflet resection device of claim 2, wherein the capture basket is a tapered mesh tube having a distal end with a first dimension in the radially expanded configuration transverse to a central longitudinal axis of the catheter and a proximal end with a second dimension in the radially expanded configuration transverse to the central longitudinal axis, wherein the second dimension is smaller than the first dimension (fig.2 of Greenberg).
Regarding claim 5, Stevens/Greenberg teaches the valve leaflet resection device of claim1, wherein the capture basket further includes a wire or tube extending proximally to an actuator to translate the capture basked proximally and distally in and out of the catheter (fig.2 of Greenberg).
Regarding claim 6, Stevens/Greenberg teaches the valve leaflet resection device of any one of claim 1, wherein the capture basket is attached to a distal end of the catheter (fig.2 of Greenberg).
Regarding claim 7, Stevens/Greenberg teaches the valve leaflet resection device of claim1, wherein the leaflet retainer comprises a wire (strut members 232) including a hook (fig.5; cusp hook 538) at a distal end thereof, wherein the wire is shape set to form the hook as the wire is distally advanced out of the catheter [0062].
Regarding claim 8, Stevens/Greenberg teaches wherein the leaflet retainer further includes an electrode at the distal end thereof configured to pierce the leaflet to be resected ([0065]: ‘The strut members 232 may also or instead be made of spring steel” of Greenberg).
Regarding claim 9, In this embodiment, Stevens/Greenberg does not teach wherein the leaflet retainer comprises a tube and a balloon slidably disposed within the tube, wherein the tube is configured to be advanced adjacent to a first side of the leaflet to be resected, the balloon in an uninflated state is configured to exit the tube and advance through the leaflet to a second side of the leaflet, and wherein the balloon is further configured to be inflated to an inflated state wherein the leaflet is captured between the balloon in the inflated state and the tube.
In another embodiment (fig. 22-23), Greenberg teaches a tube and a balloon (balloon flap 742) slidably disposed within the tube, wherein the tube is configured to be advanced adjacent to a first side of the leaflet to be resected (fig.22 and 23), the balloon in an uninflated state is configured to exit the tube and advance through the leaflet to a second side of the leaflet, and wherein the balloon is further configured to be inflated to an inflated state wherein the leaflet is captured between the balloon in the inflated state and the tube (fig.22-23, see also [0093]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to further modify the device as taught by Stevens/Greenberg with a tub and balloon as taught by Greenberg (fig.22-23) for the purpose holding the target tissue in a desired place.
Regarding claim 10, Stevens teaches that wherein the leaflet resection device comprises a tube (fig.5, the tube coupled to forceps 71). However, Stevens does not discloses a wire having a shape set tip slidably disposed within the tube, wherein the tube is configured to be advanced adjacent to a first side of the leaflet to be resected, the wire in a straightened configuration is configured to exit the tube and advance through the leaflet to a second side of the leaflet, and wherein the shape set tip is configured to bend to its shape set to capture the leaflet between the shape set tip and the tube.
Greenberg discloses a valve leaflet resection device comprising: a catheter (an apparatus 104); cutting means (216) slidably disposed within the catheter and deployable from the catheter and configured to remove a portion of a leaflet of a heart valve [0052]; wherein the leaflet resection device comprises a tube (tube coupled to strut members 232) and a wire (strut members 232) having a shape set tip slidably disposed within the tube (fig.5, see also [0065]), wherein the tube is configured to be advanced adjacent to a first side of the leaflet to be resected, the wire in a straightened configuration is configured to exit the tube and advance through the leaflet to a second side of the leaflet, and wherein the shape set tip is configured to bend to its shape set to capture the leaflet between the shape set tip and the tube [0065]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Stevens with leaflet resection device including tube and a wire having a shape set tip as taught by Greenberg for the purpose of having flexibility of capturing the desired tissue from a different angle.
Regarding claim 11, In this embodiment, Stevens/Greenberg does not disclose wherein the leaflet retainer comprises a proximal balloon and a distal balloon, wherein the proximal balloon and the distal balloon are configured to be advanced adjacent to first side of the leaflet to be resected in an uninflated state, the distal balloon in the uninflated state is configured to exit be advanced through the leaflet to a second side of the leaflet, and wherein the proximal and distal balloons are further configured to be inflated to an inflated state such that the leaflet is captured between the proximal balloon and the distal balloon.
In another embodiment (fig. 22-23), Greenberg teaches the leaflet retainer comprises a proximal balloon and a distal balloon, wherein the proximal balloon and the distal balloon are configured to be advanced adjacent to first side of the leaflet to be resected in an uninflated state, the distal balloon in the uninflated state is configured to exit be advanced through the leaflet to a second side of the leaflet, and wherein the proximal and distal balloons are further configured to be inflated to an inflated state such that the leaflet is captured between the proximal balloon and the distal balloon (fig.22-23, see also [0093]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to further modify the device as taught by Stevens/Greenberg with a tub and balloon as taught by Greenberg (fig.22-23) for the purpose holding the target tissue in a desired place.
Regarding claim 14, Stevens/Greenberg teaches the valve leaflet resection device of claim 1,wherein the leaflet retainer includes a shaft with a proximal retainer and a distal retainer disposed on the shaft, wherein the proximal and distal retainers include a radially compressed configuration when disposed within the catheter, wherein the catheter is configured to the advanced to a first side of the leaflet to be resected, the leaflet retainer is configured to be advanced from the catheter through the leaflet such that the distal retainer is on a second side of the leaflet and the proximal retainer is on the first side of the leaflet, and wherein the distal and proximal retainers are configured to radially expand to a radially expanded configuration when exiting the catheter such that the leaflet is captured between the proximal leaflet and the distal leaflet with each in the radially expanded configuration.
In another embodiment (fig. 9), Greenberg teaches wherein the leaflet retainer includes a shaft with a proximal retainer (filter basket 224) and a distal retainer (filter basket 224’) disposed on the shaft, wherein the proximal and distal retainers include a radially compressed configuration when disposed within the catheter (fig.9), wherein the catheter is configured to the advanced to a first side of the leaflet to be resected (fig.9), the leaflet retainer is configured to be advanced from the catheter through the leaflet such that the distal retainer is on a second side of the leaflet and the proximal retainer is on the first side of the leaflet (fig.9), and wherein the distal and proximal retainers are configured to radially expand to a radially expanded configuration when exiting the catheter such that the leaflet is captured between the proximal leaflet and the distal leaflet with each in the radially expanded configuration (fig.9, see also [0074]-[0075]). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to further modify the device as taught by Stevens/Greenberg with proximal and distal retainer as taught by Greenberg (fig.9) for the purpose of capturing waste tissues from both ends.
Regarding claim 15, Stevens/Greenberg teaches the valve leaflet resection device of claim 1, wherein the electrode assembly includes a first arm (first arm of cutter 65 of Stevens) and a second arm (second arm of cutter 65 of Stevens), wherein the first and second arms include a straightened configuration wherein the first and second arm are adjacent to each other (when it is in a closed position) and a splayed configuration wherein the first and second arm are separated from each other (in open position), each of the first arm and the second arm including an electrode configured to resect a portion of the leaflet to be resected (col.26, line 22-24: “Instead of or in addition to mechanical cutting means, laser, electrosurgery, or other cutting methods may be employed in the valve removal procedure”).
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens at al. (US 5,584,803) in view of Greenberg (US 2008/0039881) in further view of Goldfarb et al. (US 2002/0013571).
Regarding claim 12-13, Stevens/Greenberg does not teach the valve leaflet resection device of claim 1,wherein the leaflet retainer comprises a shape set wire configured to form a proximal radial bump and a distal radial bump in a shape set configuration, wherein the shape set wire is configured to be advanced adjacent to first side of the leaflet to be resected in a straightened configuration, the wire in the straightened configuration is configured to exit the tube and advance through the leaflet to a second side of the leaflet, and wherein the wire is configured to return to shape set configuration to capture the leaflet between the proximal radial bump on the first side of the leaflet and the distal radial bump on the second side of the leaflet and wherein the leaflet retainer includes a shaft having an auger or helical coil at a distal end of the shaft, wherein the shaft is configured to be advanced through the leaflet to be resected such that a first portion of the auger or helical coil is on a first side of the leaflet and a second portion of the auger or helical coil is on a second side of the leaflet to grasp the leaflet.
Goldfarb teaches devices for grasping, and optional repositioning and fixation of the valve leaflets to treat cardiac valve regurgitation (abstract). Goldfarb teaches wherein the leaflet retainer comprises a shape set wire configured to form a proximal radial bump (17A-D) and a distal radial bump in a shape set configuration (fig.17A-D), wherein the shape set wire is configured to be advanced adjacent to first side of the leaflet to be resected in a straightened configuration (fig.17B), the wire in the straightened configuration is configured to exit the tube and advance through the leaflet to a second side of the leaflet (fig.17C), and wherein the wire is configured to return to shape set configuration to capture the leaflet between the proximal radial bump on the first side of the leaflet and the distal radial bump on the second side of the leaflet (fig.17A-D, see also [0028]) and wherein the leaflet retainer includes a shaft having an auger or helical coil at a distal end of the shaft, wherein the shaft is configured to be advanced through the leaflet to be resected such that a first portion of the auger or helical coil is on a first side of the leaflet and a second portion of the auger or helical coil is on a second side of the leaflet to grasp the leaflet (fig.20A-B). Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Stevens/Greenberg with proximal and distal shape set wire and a shaft having an auger or helical coil at a distal end of the shaft, wherein the shaft is configured to be advanced through the leaflet to be resected as taught by Goldfarb for the purpose of having leaflet retainer with a plurality of shape set wires that allows to have different configurations to achieve the desired treatment.
Claims 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Stevens at al. (US 5,584,803) in view of Greenberg (US 2008/0039881) in further view of Engelman et al. (US 2014/0018788).
Regarding claim 16-19, Stevens/Greenberg does not teach wherein the first and second arms are formed of shape memory material and are shape set to the splayed configuration; a balloon nested between the first and second arms of the electrode assembly, wherein the balloon is configured to be inflated to separate the first and second arms into the splayed configuration; further comprising a shaft including an enlarged distal end, wherein the shaft is slidable relative to the electrode assembly, and wherein the shaft is configured to be advanced to drive the enlarged distal end between the first and second arms to splay the first and second arms to the splayed configuration and further comprising a puncture electrode disposed at a distal end of the electrode assembly with the first and second arms in the straightened configuration.
Engelman teaches a system with catheters for assessing, and treating patients. The system includes the first (fig.19A. one of 386) and second arms (the other of 386) are formed of shape memory material and are shape set to the splayed configuration [0172]; a balloon (balloon 387) nested between the first and second arms of the electrode assembly (fig.19A), wherein the balloon is configured to be inflated to separate the first and second arms into the splayed configuration (fig.19A, see also [0172]); further comprising a shaft including an enlarged distal end (the distal end of the shaft that is coupled to the balloon 387), wherein the shaft is slidable relative to the electrode assembly (fig.19A), and wherein the shaft is configured to be advanced to drive the enlarged distal end between the first and second arms to splay the first and second arms to the splayed configuration and further comprising a puncture electrode disposed at a distal end of the electrode assembly with the first and second arms in the straightened configuration [0172]. Therefore, it would have been obvious to one of ordinary skill in the art at the time the Application was effectively filed to modify the device as taught by Stevens/Greenberg with first and second arms are formed of shape memory material and are and a balloon nested between the first and second that is configured to be inflated to separate the first and second arms into the splayed configuration as taught by Engelman for accurate manipulation of the first and second arms.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGIST S DEMIE whose telephone number is (571)270-5345. The examiner can normally be reached Monday-Friday 8am-5Pm.
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/TIGIST S DEMIE/Primary Examiner, Art Unit 3794