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
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.
Claim(s) 1 and 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hojeibane (JP 2002035136 A) “Hojeibane” in view of Parodi (US 6827726 B2) “Parodi”.
Regarding Claim 1, Hojeibane teaches a deployment system (deployment system 100, par. [0023], Fig. 4) for deployment of a device to a branching implant site having a trunk (blood vessel backbone 50, par. [0027], Fig. 4), a first branch (branch portion M, par. [0027], Fig. 4), and a second branch (branch portion S, par. [0027], Fig. 4), the deployment system comprising:
an expandable branching stent prosthesis having a trunk portion (stent 10, par. [0029], Fig. 5), a first branching portion (member 12, par. [0029], Fig. 5), and a second branching portion (member 15, par. [0029], Fig. 7a);
a first balloon (balloon 102, par. [0023], Fig. 7a) disposed within the first branching portion and the trunk portion, the first balloon being configured to inflate to deploy the first branching portion and the trunk portion of the expandable branching stent prosthesis (par. [0024]);
a second balloon (balloon 104, par. [0023], Fig. 7a) disposed within the second branching portion and configured to inflate to deploy the second branching portion of the expandable branching stent prosthesis (par. [0024]), but does not teach first and second catheters coupled to the first and second balloons.
However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), comprising a first catheter (catheters 133 and 135, par. (6) Description, Fig. 7) coupled to the first balloon (balloons 34 and 35, par. (6) Description, Fig. 7) and having a first inflation lumen (branch lumen 208, par. (10), Fig. 8A), and the first catheter configured to selectively inflate the first balloon (par. (6) Description);
and a second catheter (catheter 136, par. (6) Description, Fig. 7) coupled to the second balloon (balloon 36, par. (6) Description, Fig. 7) and having a second inflation lumen (branch lumen 208, par. (10), Fig. 8A), the second catheter configured to selectively inflate the second balloon (par. (6) Description). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include first and second catheters coupled to the first and second balloons, as disclosed by Parodi, in order to properly implant the prosthesis (Parodi, pars. (4) and (5) Background).
Regarding Claim 3, Hojeibane does not teach the second catheter disposed outside the first balloon. However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), wherein the second catheter is disposed outside the first balloon (par. (6) Description, Fig. 7). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include the second catheter disposed outside the first balloon, as disclosed by Parodi, in order to help implant the respective parts of the prosthesis as desired and in the correct position (Parodi, par. (6) Description).
Regarding Claim 4, Hojeibane does not teach the second catheter with a second inflation lumen and a wire lumen having floss wire. However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), wherein the second catheter includes:
the second inflation lumen (branch lumen 208, par. (10), Fig. 8A) and an additional inflation lumen (main lumen 206, par. (10) Description, Fig. 8A) in fluid communication with the second balloon (balloon 36 or balloon 218, pars. (6) and (11) Description, Figs. 7 and 8A) and configured to selectively inflate the second balloon;
and a wire lumen (branch lumen 208, par. (10), Fig. 8A) having the floss wire (guidewire 212, par. (10) Description, Fig. 8A, guidewire travels through deployment catheter 216) extending therethrough. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include the second catheter with a second inflation lumen and a wire lumen having floss wire, as disclosed by Parodi, in order to help implant the respective parts of the prosthesis as desired and in the correct position (Parodi, par. (6) Description).
Regarding Claim 5, Hojeibane further teaches the deployment system of claim 1, wherein the floss wire (guide wire 108, par. [0024], Fig. 7a) extends through the second balloon (balloon 104).
Regarding Claim 6, Hojeibane does not teach the distal end of the floss wire terminating in a catch. However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), wherein the distal end of the floss wire (guide wires 29 and 30, par. (8) Description, Fig. 7) terminates in a catch (nosecone 14, par. (8) Description, Fig. 7). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include the distal end of the floss wire terminating in a catch, as disclosed by Parodi, in order to provide communication in the lumen and act as a conduit for the first guidewire to ensure better movement (Parodi, pars. (12) and (14) Background).
Regarding Claim 7, Hojeibane further teaches the deployment system of claim 1, wherein, when inflated, the first balloon includes:
a first balloon portion having a first diameter or a first lateral width and disposed in the first branching portion (par. [0024], balloons completely over inside of branching portion);
and a trunk balloon portion having a trunk diameter or a trunk lateral width greater than the first diameter or the first lateral width of first balloon portion, with the trunk balloon portion being disposed in the trunk portion of the expandable branching stent prosthesis (pars. [0020] and [0024], base of branches at the trunk portion has a larger diameter than the branches).
Regarding Claim 8, Hojeibane does not teach the first and second balloon configured to inflate or deflate simultaneously. However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), wherein the first inflation lumen and the second inflation lumen are fluidly coupled such that the first balloon and the second balloon are configured to inflate and/or deflate substantially simultaneously (par. (7) Description). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include the first and second balloon configured to inflate or deflate simultaneously, as disclosed by Parodi, in order to implant the parts of the prosthesis simultaneously, thus providing a smoother and more time efficient implantation (Parodi, par. (7) Description).
Regarding Claim 9, Hojeibane does not teach the first and second balloon configured to inflate or deflate simultaneously or at different times. However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), wherein the first inflation lumen and the second inflation lumen are not fluidly coupled such that the first balloon and the second balloon are configured to selectively inflate and/or deflate substantially simultaneously or at different times (par. (7) Description). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include the first and second balloon configured to inflate or deflate simultaneously or at different times, as disclosed by Parodi, in order to implant the parts of the prosthesis in the most efficient order based on vessel space or patient vasculature, thus providing a smoother and more time efficient implantation (Parodi, par. (7) Description).
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hojeibane (JP 2002035136 A) “Hojeibane” in view of McDonald (US 5676697 A) “McDonald”.
Regarding Claim 2, Hojeibane does not teach a floss wire passing through the first branching portion and out the second branching portion. However, McDonald, in the same field of art, teaches an intraluminal graft for deployment in a trunk and branch vessels (Abstract), further comprising a floss wire (guidewire 180, par. (20) Description, Fig. 7) passing through the first branching portion (right leg 116, par. (6) Description, Fig. 7) and out the second branching portion (left leg 118, par. (6), Fig. 7) of the expandable branching stent prosthesis (graft prosthesis 110, par. (6) Description, Fig. 7), the floss wire having a distal end disposed outside of the second branching portion of the expandable branching stent prosthesis (Fig. 7). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include a floss wire passing through the first branching portion and out the second branching portion, as disclosed by McDonald, in order to help advance the assembly of the prosthesis (McDonald, par. (20) Description).
Claim(s) 10-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hojeibane (JP 2002035136 A) “Hojeibane” in view of McDonald (US 5676697 A) “McDonald”, and further in view of Fleming (US 20140180379 A1) “Fleming”.
Regarding Claim 10, Hojeibane teaches a method comprising:
delivering, to a branching implant site comprising a trunk (blood vessel backbone 50, par. [0027], Fig. 4), a first branch (branch portion M, par. [0027], Fig. 4), and a second branch (branch portion S, par. [0027], Fig. 4), a deployment system (deployment system 100, par. [0023], Fig. 4) via the first branch, the deployment system comprising:
an expandable branching stent prosthesis having a trunk portion (stent 10, par. [0029], Fig. 5), a first branching portion (member 12, par. [0029], Fig. 5), and a second branching portion (member 15, par. [0029], Fig. 7a);
a first balloon (balloon 102, par. [0023], Fig. 7a) disposed within the first branching portion and the trunk portion of the expandable branching stent prosthesis;
a second balloon (balloon 104, par. [0023], Fig. 7a) disposed within the second branching portion;
inflating the first balloon (balloon 102) to expand the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis for deployment (pars. [0024] and [0029], Fig. 7a);
and inflating the second balloon (balloon 104) to expand the second branching portion of the expandable branching stent prosthesis for deployment (par. [0030], Fig. 7a), but does not teach a floss wire passing through the first branching portion and out the second branching portion and the floss wire connected to the snare wire.
However, McDonald, in the same field of art, teaches an intraluminal graft for deployment in a trunk and branch vessels (Abstract), comprising a floss wire (guidewire 180, par. (20) Description, Fig. 7) passing through the first branching portion (right leg 116, par. (6) Description, Fig. 7) and out the second branching portion (left leg 118, par. (6), Fig. 7) of the expandable branching stent prosthesis (graft prosthesis 110, par. (6) Description, Fig. 7), the floss wire having a distal end disposed outside of the second branching portion of the expandable branching stent prosthesis (Fig. 7);
Fleming, in the same field of art, teaches an intraluminal guiding device for a bifurcated stent graft (Abstract) with a method of delivering a distal end of a snare wire (pre-loaded wire 121, par. [0060], Fig. 12) to the branching implant site via the second branch (iliac artery 102, par. [0060], Fig. 12), the snare wire extending back through the second branch;
connecting the distal end of the floss wire (first guidewire 122, par. [0060], Fig. 12) and the distal end of the snare wire together at the branching implant site (Fig. 12);
using one or more of the floss wire and the snare wire to seat the first branching portion of the expandable branching stent prosthesis along the first branch of the branching implant site and the second branching portion of the expandable branching stent prosthesis along the second branch of the branching implant site (first guidewire 122, par. [0060], Fig. 12). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane to include a floss wire passing through the first branching portion and out the second branching portion, as disclosed by McDonald, in order to help advance the assembly of the prosthesis (McDonald, par. (20) Description). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane in view of McDonald to include the floss wire connected to the snare wire, as disclosed by Fleming, in order to help connect the delivery systems and advance the intraluminal device through the arteries (Fleming, par. [0060]).
Regarding Claim 11, Hojeibane in view of McDonald does not teach pulling the snare wire to bring the distal end of the floss wire through the second branch and out of an access incision of the second branch. However, Fleming, in the same field of art, teaches an intraluminal guiding device for a bifurcated stent graft (Abstract), further comprising, after inflating the first balloon and the second balloon, pulling the snare wire to bring the distal end of the floss wire through the second branch and out of an access incision of the second branch (pars. [0042] and [0051], Figs. 8b and 12, balloon coves inner member 202, which is connected to both snare and floss wires). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane in view of McDonald to include pulling the snare wire to bring the distal end of the floss wire through the second branch and out of an access incision of the second branch, as disclosed by Fleming, in order to help connect the delivery systems and advance the intraluminal device through the arteries (Fleming, par. [0060]).
Regarding Claim 18, Hojeibane in view of McDonald does not teach connecting the distal ends of the floss wire and snare wire. However, Fleming, in the same field of art, teaches an intraluminal guiding device for a bifurcated stent graft (Abstract), wherein connecting the distal end of the floss wire (first guidewire 122, par. [0060], Fig. 12) and the distal end of the snare wire (pre-loaded wire 121, par. [0060], Fig. 12) together at the branching implant site includes connecting the distal end of the snare wire to a catch (snare 131, par. [0060], Fig. 12) at the distal end of the floss wire. It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane in view of McDonald to include connecting the distal ends of the floss wire and snare wire, as disclosed by Fleming, in order to help connect the delivery systems and advance the intraluminal device through the arteries (Fleming, par. [0060]).
Regarding Claim 19, Hojeibane further teaches the method of claim 10, wherein inflating the first balloon (balloon 102) to expand the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis for deployment (pars. [0024] and [0029], Fig. 7a) includes:
inflating a first balloon portion of the first balloon to a first diameter or a first lateral width to expand the first branching portion of the expandable branch stent prosthesis (par. [0024], balloons completely over inside of branching portion);
and inflating a trunk balloon portion of the first balloon to a trunk diameter or the trunk lateral width that is greater than the first diameter or the first lateral width of the first balloon portion to expand the trunk portion of the expandable branching stent prosthesis (pars. [0020] and [0024], base of branches at the trunk portion has a larger diameter than the branches).
Regarding Claim 20, Hojeibane further teaches the method of claim 19, wherein inflating the second balloon (balloon 104) to expand the second branching portion of the expandable branching stent prosthesis for deployment (par. [0030], Fig. 7a) includes:
inflating the second balloon to a second diameter or second lateral width that is less than the trunk diameter or the trunk lateral width of the trunk balloon portion (Fig. 7a).
Claim(s) 12-17 are rejected under 35 U.S.C. 103 as being unpatentable over Hojeibane (JP 2002035136 A) “Hojeibane”, McDonald (US 5676697 A) “McDonald”, and Fleming (US 20140180379 A1) “Fleming”, as applied to claim 10 above, and further in view of Parodi (US 6827726 B2) “Parodi”.
Regarding Claim 12, Hojeibane, McDonald, and Fleming teach the method of claim 10, wherein: inflating the first balloon (balloon 102) to expand the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis for deployment (pars. [0024] and [0029], Fig. 7a) includes:
inflating the second balloon (balloon 104) to expand the second branching portion of the expandable branching stent prosthesis for deployment (par. [0030], Fig. 7a), but does not teach inflating the first and second balloons coupled to their respective catheters and having inflation lumens.
However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background) with a method of inflating the first balloon (balloons 34 and 35, par. (6) Description, Fig. 7) with a first catheter (catheters 133 and 135, par. (6) Description, Fig. 7) coupled to the first balloon and having a first inflation lumen (branch lumen 208, par. (10), Fig. 8A) in fluid communication with the first balloon to expand the trunk portion of the expandable branching stent prosthesis and the first branching portion of the expandable branching stent prosthesis for deployment (par. (6) Description, Fig. 7);
inflating the second balloon (balloon 36, par. (6) Description, Fig. 7) with a second catheter (catheter 136, par. (6) Description, Fig. 7) coupled to the second balloon and having a second inflation lumen (branch lumen 208, par. (10), Fig. 8A) to expand the second branching portion of the expandable branching stent prosthesis for deployment (par. (6) Description, Fig. 7). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the combination of Hojeibane, McDonald, and Fleming to include inflating the first and second balloons coupled to their respective catheters and having inflation lumens, as disclosed by Parodi, in order to implant the parts of the prosthesis simultaneously, thus providing a smoother and more time efficient implantation (Parodi, par. (7) Description).
Regarding Claim 13, Hojeibane in view of McDonald does not teach the second catheter including the second inflation lumen and an additional inflation lumen and a wire lumen with the floss wire extending therethrough. However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), wherein the second catheter (catheter 136, par. (6) Description, Fig. 7) includes: the second inflation lumen (branch lumen 208, par. (10), Fig. 8A) and an additional inflation lumen (main lumen 206, par. (10) Description, Fig. 8A) in fluid communication with the second balloon and configured to selectively inflate the second balloon (Figs. 7 and 8A);
Fleming, in the same field of art, teaches an intraluminal guiding device for a bifurcated stent graft (Abstract) comprising a wire lumen (distal lumen 112, par. [0060], Fig. 12) having the floss wire (first guidewire 122, par. [0060], Fig. 12) extending therethrough until the floss wire is pulled through the second branch and out of the access incision of the second branch (Fig. 12). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane in view of McDonald to include the second catheter including the second inflation lumen and an additional inflation lumen, as disclosed by Parodi, in order to implant the parts of the prosthesis simultaneously, thus providing a smoother and more time efficient implantation (Parodi, par. (7) Description). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by Hojeibane in view of McDonald to include a wire lumen with the floss wire extending therethrough, as disclosed by Fleming, in order to help connect the delivery systems and advance the intraluminal device through the arteries (Fleming, par. [0060]).
Regarding Claim 14, Hojeibane, McDonald, and Fleming do not teach the floss wire extending through the second balloon until the floss wire is pulled through the second branch and out of the access incision. However, Fleming, in the same field of art, teaches an intraluminal guiding device for a bifurcated stent graft (Abstract), wherein the floss wire (first guidewire 122, par. [0060], Fig. 12) extends through the second balloon until the floss wire is pulled through the second branch and out of the access incision of the second branch (Fig. 12). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the combination of Hojeibane in view of McDonald to include floss wire extending through the second balloon until the floss wire is pulled through the second branch and out of the access incision, as disclosed by Fleming, in order to help connect the delivery systems and advance the intraluminal device through the arteries (Fleming, par. [0060]).
Regarding Claim 15, Hojeibane in view of McDonald teaches the method claim 13, further comprising:
deflating the first balloon and the second balloon (par. [0007], but does not teach pulling the snare wire to bring the distal end of the floss wire through the second branch.
However, Fleming, in the same field of art, teaches an intraluminal guiding device for a bifurcated stent graft (Abstract) with a method of pulling the snare wire (pre-loaded wire 121, par. [0060], Fig. 12) to bring the distal end of the floss wire through the second branch, removing the deployment system from the branching implant site by pulling the first catheter and/or the second catheter such that the second balloon is pulled from the second branch, over a bifurcation between the second branch and the first branch, and through the first branch (par. [0056], first catheter as part of first delivery system may decouple from second delivery system). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the combination of Hojeibane in view of McDonald to include pulling the snare wire to bring the distal end of the floss wire through the second branch, as disclosed by Fleming, in order to remove the delivery systems as needed and, in a way, to not disarrange the prosthesis (Fleming, par. [0056]).
Regarding Claim 16, Hojeibane, McDonald, and Fleming do not teach selectively disconnecting the first catheter from the second catheter before removing the deployment system. However, Parodi, in the same field of art, teaches a branched deployment catheter for a branches prothesis (Abstract, par. (12) Background), further comprising selectively disconnecting the first catheter from the second catheter before removing the deployment system from the branching implant site, wherein removing the deployment system from the branching implant site by pulling the first catheter and/or the second catheter includes pulling the first catheter to remove the first balloon and pulling the second catheter separate from the first catheter to remove the second balloon (Claims 16 and 18). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the structure disclosed by the combination of Hojeibane, McDonald, and Fleming to include selectively disconnecting the first catheter from the second catheter before removing the deployment system, as disclosed by Parodi, in order to implant the parts of the prosthesis in a way that provides a smoother and more efficient implantation (Parodi, par. (7) Description).
Regarding Claim 17, Hojeibane further teaches the method of claim 15, wherein the first catheter is selectively or fixedly connected to the second catheter such that removing the deployment system from the branching implant site by pulling the first catheter and/or the second catheter includes removing the deployment system from the branching implant site by pulling either one of the first catheter or the second catheter to pull the first balloon from the first branch and pull the second balloon from the second branch, over the bifurcation between the second branch and the first branch, and through the first branch (pars. [0004] and [0024], first catheter and second catheter can be connected through consideration of catheter 200 as a whole, which covers balloons 102 and 104 that will be pulled from the branches).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE NICOLE THOMAS whose telephone number is (571)272-0004. The examiner can normally be reached Monday - Friday 8:30am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached at (408)918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NATALIE N THOMAS/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
Prosecution Insights