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 Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites the limitation “the exterior surface” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction is required.
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 1-3, 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Ressemann et al. (US 2003/0050600 A1) in view of Mische (US 5,360,403).
Regarding claims 1 and 2, Ressemann discloses a guide catheter extension (entire device shown in figure 2C except for element 260), comprising:
a push member 210, 220 having a proximal end (end of element 210 coupled to element 205) and a distal end (end of element 220 coupled to element 232);
a tube frame 232 coupled to the distal end of the push member 210, 220, the tube frame 232 defining a lumen 240 having a diameter sufficient to receive an interventional vascular device therethrough and comprising a flange (see “F” in figure 2C below); and
an inflatable element 233, 234, 236 coupled to the tube frame but is silent regarding wherein the inflatable element is expandable into the lumen wherein the inflatable element is expandable to occupy between 10% and 90% of a cross-sectional area of the lumen.
However, Mische teaches a design of a balloon catheter (figure 10) with lumen occluder wherein the inflatable element 110 is expandable into the lumen 106 wherein the inflatable element 110 is expandable to occupy between 10% and 90% (since element 110 is completely occupying the lumen 106 upon full inflation, element 110 is capable to occupy a cross-sectional area of the lumen between 10% and 90% if element 110 is expanded to certain level) of a cross-sectional area of the lumen 106 for the purpose of occluding the open lumen when inflating the balloon in a single operation (column 2, lines 15-19) as required by the medical procedure involving delivery of the fluid to the target site (column 3, lines 41-52).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the inflatable element of Ressemann to incorporate wherein the inflatable element is expandable into the lumen wherein the inflatable element is expandable to occupy between 10% and 90% of a cross-sectional area of the lumen as taught by Mische for the purpose of occluding the open lumen when inflating the balloon in a single operation (column 2, lines 15-19) as required by the medical procedure involving delivery of the fluid to the target site (column 3, lines 41-52).
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Regarding claim 3, Ressemann discloses wherein the inflatable element 233, 234 is expandable outward beyond an exterior surface (exterior surface of element 232) of the tube frame 232 into a space (space between element 232 and element 260) between the guide catheter extension and a surrounding guide catheter 260.
Regarding claim 5, Ressemann discloses wherein the push member 210, 220 includes an inflation lumen 242 (paragraph 0131, lines 4-10) in fluid communication with an interior of the inflatable element 233, 234, 236.
Regarding claim 6, Ressemann is silent regarding wherein at least a portion of the inflation lumen defines an arcuate cross-section having a radius of curvature equal to a radius of the lumen of the tube frame.
However, Mische teaches wherein at least a portion of the inflation lumen defines an arcuate cross-section (see “AC” in figure 10 below) having a radius of curvature (radius of curvature of “AC” in figure 10 below) equal to a radius (radius of element 106) of the lumen of the tube frame for the purpose of occluding the open lumen when inflating the balloon in a single operation (column 2, lines 15-19) as required by the medical procedure involving delivery of the fluid to the target site (column 3, lines 41-52).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the inflatable element of Ressemann to incorporate wherein at least a portion of the inflation lumen defines an arcuate cross-section having a radius of curvature equal to a radius of the lumen of the tube frame as taught by Mische for the purpose of occluding the open lumen when inflating the balloon in a single operation (column 2, lines 15-19) as required by the medical procedure involving delivery of the fluid to the target site (column 3, lines 41-52).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ressemann et al. (US 2003/0050600 A1) in view of Mische (US 5,360,403) and further in view of Taricco (US 3,833,003).
Regarding claim 4, Ressemann/Mische (hereinafter referred as “modified Ressemann”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Ressemann is silent regarding wherein the tube frame defines a window therein through which the inflatable element is expandable outward beyond the exterior surface of the tube frame.
However, Taricco teaches a design of a catheter with a balloon (figure 1) wherein the tube frame 60 defines a window 15 (a gap formed between elements 18 and 17 that allows element 16 to expand outward) therein through which the inflatable element 16 is expandable outward beyond the exterior surface of the tube frame 60 for the purpose of using a well-known configuration to attach the balloon to the tube frame (column 3, lines 43-60).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing of the claimed invention to modify the tube frame of modified Ressemann to incorporate wherein the tube frame defines a window therein through which the inflatable element is expandable outward beyond the exterior surface of the tube frame as taught by Taricco for the purpose of using a well-known configuration to attach the balloon to the tube frame (column 3, lines 43-60).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ressemann et al. (US 2003/0050600 A1) in view of Mische (US 5,360,403) and further in view of Patel (US 4,447,228).
Regarding claim 7, modified Ressemann discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Ressemann is silent regarding further comprising a tongue element extending from a proximal segment of the tube frame, wherein the tongue element is directly coupled to the distal end.
However, Patel teaches a design of a catheter (figure 2) comprising a tongue element 48 extending from a proximal segment (segment of element 30 comprising element 48) of the tube frame 30, wherein the tongue element 30 is directly coupled to the distal end (end of element 12 comprising element 40) for the purpose of connecting two structures together using a well-known bonding technique (column 3, lines 1-11).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the connection between the tube frame and the push member of modified Ressemann to incorporate further comprising a tongue element extending from a proximal segment of the tube frame, wherein the tongue element is directly coupled to the distal end as taught by Patel for the purpose of connecting two structures together to achieve relatively continuous inner surface when using a bonding technique (column 3, lines 1-11).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Ressemann et al. (US 5,466,222): discloses a guide catheter extension comprising a push member and a tube frame.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783