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 . Claims 1-15 are pending examination below.
Claim Rejections - 35 USC § 102
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 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 1-7, 9-11 and 12 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by US 10,603,197 B2 (hereinafter, "Marmur").
In regards to claim 1, Marmur discloses a system for delivery of an endoluminal prosthesis (Fig. 1, deployment system, 10, col. 28 lines 7-15, described as being used to deliver a stent to the lumen of a human body),
the system comprising: a delivery catheter (see below, annotated Fig. 1, DS1, col. 28 lines 12-15)
and a prosthesis (Fig. 6C, stent-graft, 40, col. 28 lines 21-29) to be delivered,
the delivery catheter comprising a catheter tip (Fig. 2, distal tip, 32, col. 28 lines 33-37),
a catheter shaft (Fig. 2, delivery shaft, 30, col. 28, lines 12-21) or,
and a handle (see below, annotated Fig. 1, H1; col. 28 lines 12-15; see also Fig. 14B, control handle, 20 and col. 46, lines 47-49)
for deployment of the prosthesis, the prosthesis comprising a hollow-cylindrical main body (see below, annotated Fig. 7C, CB1, col. 37 lines 56-62)
having a side wall (see below, annotated Fig. 7C, SW1, col. 37 lines 56-62),
a proximal opening (see below, annotated Fig. 13I, PO1)
and a distal opening (see below, annotated Fig. 13I, DO1)
and a main lumen extending there between (Fig. 13J, second longitudinal portion, 570, col. 42 lines 20-42),
the system further comprising a wire (Fig. 1, guidewire, 100, col. 35 lines 64 - col. 36 line 4)
extending through at least a portion of the main lumen of the prosthesis in a preloaded configuration (Fig. 13J, second longitudinal portion, 570, col. 42 lines 20-42),
the wire extending in distal direction (see below, annotated Fig. 13I, DW1, inner shaft and inner cannula containing guidewires are shown in figure)
to a position in proximity to the distal opening of the prosthesis and the wire extending in proximal direction proximal (see below, annotated Fig. 13I, directional markers) of the proximal opening of the prosthesis along the catheter shaft (Fig. 2, delivery shaft, 30, col. 28, lines 12-21)
up to the handle (Fig. 14B, control handle, 20, col. 46 lines 47-49),
wherein the handle comprises at least one spool (Fig. 15B, spool, 820, col. 48 lines 14-21)
to receive the proximal end of the preloaded wire (Fig. 15A, restraining wire, 460, col. 48 lines 14-26)
with a proximal portion of the preloaded wire being coiled onto the spool (Fig. 15B, spool, 820, in combination with restraining wire, 460, col. 48 lines 14-26).
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In regards to claim 2, Marmur further disclose wherein the prosthesis (Fig. 14, prosthesis, 100, para 0085)
is a stent, a graft, a stent graft (Fig. 6C, stent-graft, 40, col. 28 lines 21-29; see also, stent graft, 140, col. 7 lines 46-51) or any combination thereof.
In regards to claim 3, Marmur further discloses wherein the prosthesis (Fig. 14, prosthesis, 100, para 0085)
comprises at least one fenestration (Fig. 7A-7C, fenestrations, 180 and 182, col. 37, lines 56-62) in the side wall (see above, annotated Fig. 7C, SW1, col. 37 lines 56-62)
of the hollow-cylindrical main body (see above, annotated Fig. 7C, CB1, col. 37 lines 56-62).
In regards to claim 4, Marmur further discloses wherein the prosthesis comprises at least one side branch (Fig. 13I, branching stent grafts, 690A-C, col. 46 lines 23-28),
the side branch comprising a hollow-cylindrical side branch body (see below, annotated Fig. 13J, SB1, see also branching stent grafts, 690A-C, col. 46 lines 35-40)
having a side wall (see below, annotated Fig. 13J, SBW1, col. 37 lines 56-62),
a proximal opening (see below, annotated Fig. 13J, PO1)
and a distal opening (see below, annotated Fig. 13J, DO1)
and a side branch lumen extending there between (Fig. 13I, branch stent grafts, 690A-C, col. 46 lines 23-28, where lumen is defined as an opening),
wherein the side branch lumen (Fig. 13I, branch stent grafts, 690A-C, col. 46 lines 22-30, where lumen is defined as an opening)
is in fluid communication (Fig. 13J, branch stent grafts, 690A-C, connected to second longitudinal portion, 570, col. 43 lines 15-47)
with the main lumen (Fig. 13J, second longitudinal portion, 570, col. 42 lines 20-42).
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In regards to claim 5, Marmur further discloses wherein the preloaded wire (Fig. 15B, restraining wire, 460, col. 47 lines 46-55)
extends from the spool (Fig, 15B, spool, 820, col. 48 lines 14-21)
at the proximal end of the catheter (Fig. 1 and Fig. 15B, control handle, 20, in combination with spool, 820, and restraining wire, 460, col. 46 lines 47-54)
to a position outside the main lumen (Fig. 13J, second longitudinal portion, 570, col. 41 lines 24-37)
of the prosthesis in a proximal region of the prosthesis (Fig.6C, stent-graft, 40, col. 28 lines 21-29),
extending through the fenestration (Fig. 7A-7C, fenestrations, 180 and 182, col. 37, lines 56-62) in the side wall of the hollow-cylindrical main body (Fig. 13I, longitudinal portion, 570, col. 41 lines 24-37)
into the lumen of the prosthesis (Fig. 13I, first longitudinal portion, 470, col. 42 lines 20-42),
and extending further inside the lumen of the main body (Fig. 13I, first longitudinal portion, 470, col. 41 lines 24-37)
to a position in proximity to the distal end (see below, annotated Fig. 13I, DO1 and DW1, col. 3 lines 44-51), extending from the distal portion) of the prosthesis.
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In regards to claim 6, Marmur further discloses wherein the preloaded wire (Fig. 15B, restraining wire, 460, col. 47 lines 46-55)
extends from the spool (Fig. 15B, restraining wire, 460, in combination with spool, 820, col. 48 lines 14-21)
at the proximal end of the catheter (see below, annotated Fig. 1, DS1 and directional markers, col.28 lines 7-15, see also col. 49 lines 27-35 )
to a position outside the main lumen (Fig. 13J, first longitudinal portion, 470, col. 41 lines 24-37) of the prosthesis
in a proximal region of the prosthesis (Fig. 6C, stent-graft, 40, col. 28 lines 21-29)
and further extending into the side branch lumen (Fig. 13I, branch stent grafts, 690A-C, in combination with guidewires, 680A-C, col. 46 lines 22-30, where lumen is defined as an opening).
In regards to claim 7, Marmur further discloses wherein the preloaded wire (Fig. 12A-C, restraining wire, 460, col. 47 lines 46-55)
extends from the spool (Fig. 15B, spool, 820, col. 48 lines 14-21)
at the proximal end of the catheter (see below, annotated Fig. 1, directional markers, DS1 in combination with control handle, 20, col. 46 lines 47-49)
to a position outside the main lumen of the prosthesis (Fig. 13I, first longitudinal portion, 470, col. 41 lines 24-37)
in a proximal region of the prosthesis (Fig. 6C, stent-graft, 40, col. 28 lines 21-29),
extending into the side branch lumen (Fig. 13I, branch stent grafts, 690A-C, where lumen is defined as an opening),
and extending further inside the side branch lumen (Fig. 12A, first conduit, 450A-B, col. 42 lines 11-19)
into the main lumen (Fig. 13J, second longitudinal portion, 570, col. 41 lines 24-37) of the prosthesis to a position in proximity to the distal end of the prosthesis (see above, annotated Fig. 13I, DO1).
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In regards to claim 9, Marmur further discloses wherein the delivery catheter (see below, annotated Fig. 1, DS1, col. 28 lines 12-15)
further comprises a guidewire lumen (Fig . 4A, inner shaft, 36, in combination with guidewire bore, 102, col. 36 lines 2-13)
to receive a guidewire (Fig. 4A, guidewire, 100, col. 36 lines 2-13).
In regards to claim 10, Marmur further discloses wherein the spool (spool, 820, col. 48 lines 14-21)
is attached to the handle (see above, annotated Fig. 1, H1, col. 28 lines 12-15 see also Fig. 14B, control handle, 20, col. 46 lines 47-49)
via a retainer (Fig. 15B, proximal portion, 472A, col. 43 lines 59-66).
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 8 is rejected under 35 U.S.C. 103 as being unpatentable over US 10,603,197 B2 (hereinafter, "Marmur") in view of US 9,149,382 B2 (hereinafter, "Greenberg") .
In regards to claim 8, Marmur discloses the system according to claim 1 (Fig. 1, deployment system, 10, col. 28 lines 7-15, described as being used to deliver a stent to the lumen of a human body), wherein the prosthesis (Fig. 6C, stent-graft, 40, col. 28 lines 21-29)
comprises side branches (Fig. 13E, lateral fenestrations, 180, 182, and 184, col. 45 lines 37-42),
each side branch having a side branch lumen (Fig. 13I, branch stent grafts, 690A-C, where lumen is defined as an opening),
each side branch lumen being in fluid communication (Fig. 13J, branch stent grafts, 690A-C, connected to second longitudinal portion, 570, col. 43 lines 15-47)
with the main lumen (Fig. 13J, second longitudinal portion, 570, col. 42 lines 20-42)
and each side branch lumen receiving a preloaded wire (Fig. 13I, guidewires, 680A-C, col. 46 lines 22-30).
However, Marmur does not explicitly disclose the prosthesis has four side branches. Greenberg teaches an endoluminal prosthesis (Fig. 8, prosthesis, 210, col. 12 lines 16-25) comprising four side branches (Fig. 8, branches, 240, 250, 260, and 270, col. 12 lines 16-54).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the prosthesis of Marmur to include the four side branches of Greenberg since doing so merely involves combining prior art elements according to know methods to yield predictable results (see MPEP 2143).
Claims 11-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,603,197 B2 (hereinafter, "Marmur") in view of US 2025/0099716 A1 (hereinafter, "Parikh") .
In regards to claim 11, the system according to claim 1 (Fig. 1, deployment system, 10, col. 28 lines 7-15, described as being used to deliver a stent to the lumen of a human body), wherein the spool (Fig. 15B, spool, 820, col. 48 lines 14-26)
and/or the retainer (Fig. 15B, proximal portion, 472A, col. 43 lines 59-66)
However, Marmur does not explicitly disclose that the spool and retainer is detachable from the handle. Parikh which teaches a guide catheter (Fig. 1, guide catheter, 100, para 0040) discloses a spool (Fig. 32A-B, spool, 4208, para 0107) which is detachable (Fig. 32A, spool, 4208, para 0107, states the spool can be disposable and there includes that the spool can be dethatched and removed) from the handle (Fig. 13-16, handle, teaches that the illustrated handles can be used with any of the guide catheters disclosed, see also Fig. 18A-H, catheter control system, 1800, para 0083). Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the spool of Marmur to be detachable from the spool and/or retainer to so that the spool can be replaced or reused (Parikh, para 0107).
In regards to claim 12, Marmur further discloses wherein the spool (Fig. 15B, spool, 820, col. 48 lines 14-21)
is attached to the retainer (Fig. 15B, proximal portion, 472A, col. 43 lines 59-66).
However, Marmur does not explicitly state that the retainer is connected to the spool by a releasable connector. Parikh furthers teaches that the spool (Fig. 32A, spool, 4208, para 0107) is attached to a retainer (Fig. 36A, ratchet, 4506, in combination with ratchet wheel, 4514, para 0111) by a releasable connector ( Fig. 36B, release button, 4510, para 0111).
Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the spool of Marmur to be releasable connector of Parikh in order to disengage the spool, adjust wire wrapping or replace the spool as needed (Parikh, para 0111).
In regards to claim 15, Marmur further discloses wherein the handle (Fig. 14B, control handle, 20, col. 46 lines 47-49)
and a preloaded wire accommodated in the system (Fig. 1, deployment system, 10, col. 28 lines 7-15, described as being used to deliver a stent to the lumen of a human bod).
However, Marmur does not explicitly disclose wherein the handle comprises at least one seal per preloaded wire. Parikh further discloses that the spool mechanism (Fig. 8C-D, spool mechanism, 802, in combination with wire, 804, para 0068) comprises at least one seal. Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the spool of Marmur to include the seal of Parikh to prevent fluid from entering the spool mechanism (Parikh, para 0068).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,603,197 B2 (hereinafter, "Marmur"), as applied to claim 1 above, further in view of US 9,149,382 B2 (hereinafter, "Greenberg") and US 2025/0099716 A1 (hereinafter, "Parikh").
In regards to claim 13, Marmur discloses the system (Fig. 1, deployment system, 10, col. 28 lines 7-15, described as being used to deliver a stent to the lumen of a human body) wherein the endoluminal prosthesis (Fig. 6C, stent-graft, 40, col. 28 lines 21-29, see also stent graft, 140, col. 7 lines 46-51)
comprises side branches (Fig. 13I, branching stent grafts, 690A-C, col. 46 lines 23-28),
each side branch receiving a preloaded wire (Fig. 15B, restraining wire, 460, col. 47 lines 46-55) and wherein the handle comprises spools (Fig. 15B, spool, 820, in combination with control handle, 20, col. 48 lines 14-21),
each spool (Fig. 15B, spool, 820, col. 48 lines 14-26)
receiving one preloaded wire (Fig. 15B, restraining wire, 460, col. 47 lines 46-55).
However, Marmur does not explicitly disclose the prosthesis has four side branches, wherein the handle comprises four spools. Greenberg teaches an endoluminal prosthesis (Fig. 8, prosthesis, 210, col. 12 lines 16-25)
comprising four side branches (Fig. 8, branches, 240, 250, 260, and 270, col. 12 lines 16-54). Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the prosthesis of Marmur to include the four side branches of Greenberg since doing so merely involves combining prior art elements according to know methods to yield predictable results (see MPEP 2143).
However, Marmur in view of Greenberg does not explicitly disclose four spools with each receiving one preloaded wire. Parikh teaches a guide extensions catheter (Fig. 2A, guide extension catheter, 212, para 0045) that comprises four spools (Fig. 33, spool mechanisms, 4200, in combination with spool 4208, para 0108) receiving one preloaded wire (Fig. 32, wire, 4202, para 0107). Therefore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify the prosthesis of Marmur in view of Greenberg to include the four spools of Parikh to combine multiple spool mechanisms since doing so merely involves combining prior art elements according to know methods to yield predictable results (see MPEP 2143).
In regards to claim 14, Marmur further discloses wherein two spools (Fig. 15B, spools, 820 and 840, col. 48 lines 14-26)
at a time are coupled (Fig. 15B, proximal portion, 472B, col. 43 lines 59-66)
to the handle via one retainer (Fig. 15B, proximal portion, 472A, col. 43 lines 59-66),
while each spool can be operated separately (col. 48 lines 26- 31).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JICHELE MONIQUE SANDERS whose telephone number is (571)272-2240. The examiner can normally be reached M-Thu 6:30-5:15.
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/J.M.S./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774