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
Claims 6 and 7 is objected to because of the following informalities: the claims recite “radioplaque” which based on the description in the specification appears to be a misspelling of radiopaque. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: line 1 recites “both balloons” which should be “both the first and second balloons”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: line 2 recites “either balloon” which should be “either the first and second balloons”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: line 3-4 recites “to remove the implanted stents or other implanted material inside the arteries or vein the radioplaque material comprises platinum” which should be “to remove the implanted stents or other implanted material inside the arteries or vein, the radioplaque material comprises platinum”. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: line 2 recites “the scoring wires” which should be “the one or more scoring wires”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: line 2 recites “the scoring wires” which should be “the one or more scoring wires”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: line 1 recites “the scoring wire” which should be “the one or more scoring wires”. Appropriate correction is required.
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 11, 12, 15, 19, and 20 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.
Claim 11 recites “the distal balloon is maintained in an inflated state to occlude blood flow while the scoring wires of the proximal balloon engage and cut through and loosen material adhering to the vein or artery to block the material from flowing past the distal balloon” which reads as a method claim but the claim is an apparatus claim rendering the scope unclear. For examination purposes, the claim is being interpreted as “the distal balloon is configured to be maintained in an inflated state to occlude blood flow while the scoring wires of the proximal balloon engage and cut through and loosen material adhering to the vein or artery to block the material from flowing past the distal balloon”.
Claim 12 recites “the proximal balloon is maintained in an inflated state to occlude blood flow while the scoring wires of the distal balloon engage and cut through and loosen material adhering to the vein or artery to block the material from flowing past the proximal balloon” which reads as a method claim but the claim is an apparatus claim rendering the scope unclear. For examination purposes, the claim is being interpreted as “the proximal balloon is configured to be maintained in an inflated state to occlude blood flow while the scoring wires of the distal balloon engage and cut through and loosen material adhering to the vein or artery to block the material from flowing past the proximal balloon”.
Claim 15 recites “the inner inflation shaft to carry the gas, liquid or solution that enters the distal balloon inflation port and flows from the output port to the distal balloon to inflate the distal balloon and the outer inflation shaft to carry the gas, liquid or solution, that enters the proximal balloon inflation port and flows from the output port to the proximal balloon to inflate the proximal balloon at concurrent, overlapping, or non-overlapping time periods” which reads as a method claim but the claim is an apparatus claim rendering the scope unclear. For examination purposes, the claim is being interpreted as “the device is configured such that the inner inflation shaft to carry the gas, liquid or solution that enters the distal balloon inflation port and flows from the output port to the distal balloon to inflate the distal balloon and the outer inflation shaft to carry the gas, liquid or solution, that enters the proximal balloon inflation port and flows from the output port to the proximal balloon to inflate the proximal balloon at concurrent, overlapping, or non-overlapping time periods”.
Claim 19 recites “the distal balloon and proximal balloon are inflated independent of each other” which reads as a method claim but the claim is an apparatus claim rendering the scope unclear. For examination purposes, the claim is being interpreted as “the distal balloon and proximal balloon are configured to be inflated independent of each other”.
Claim 20 recites “the distal balloon and the proximal balloon are inflated at one of simultaneous, concurrent, overlapping, and non-overlapping time periods” which reads as a method claim but the claim is an apparatus claim rendering the scope unclear. For examination purposes, the claim is being interpreted as “the distal balloon and the proximal balloon are configured to be inflated at one of simultaneous, concurrent, overlapping, and non-overlapping time periods”.
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.
Claims 1-3, 9, 15, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Imran (US 5,833,650) in view of Zadno-Azizi (US 20020052638 A1).
Regarding claim 1 Imran discloses (fig. 1-4) a medical device, comprising:
a distal balloon inflation port 62 (see fig. 1 and col. 4 ln. 51-65), and a proximal balloon inflation port 24 (see fig. 1 and col. 3 ln. 54-65);
a distal balloon 58;
a flexible inner inflation shaft 51 (see col. 4 ln. 44-50) having a first length (see fig. 1), a proximal end coupled to the distal balloon inflation port 62 (see col. 4 ln. 51-65), and a distal end coupled to the distal balloon 58 (see fig. 1 and col. 4 ln. 51-65), the inner inflation shaft 51 to carry a gas, liquid or solution that enters the distal balloon inflation port to the distal balloon to inflate the distal balloon 58 (see col. 4 ln. 51-65);
a proximal balloon 19; and
a flexible outer inflation shaft 16 (see col. 3 ln. 34-53) surrounding and coaxially aligned with the inner inflation shaft 51 (see fig. 1 and 4) and having a second length shorter than the first length (see fig. 1), a proximal end coupled to the proximal balloon inflation port 24 (see col. 3 ln. 54-65), and a distal end coupled to the proximal balloon 19 (see fig. 1 and col. 3 ln. 54-65), the outer inflation shaft 16 to carry a gas, liquid or solution that enters the proximal balloon inflation port to the proximal balloon to inflate the proximal balloon (see col. 3 ln. 54-65).
Imran is silent regarding a hub having an output port; the inner inflation shaft to carry a gas, liquid or solution through the output port; the outer inflation shaft to carry a gas, liquid or solution from the output port.
However Zadno-Azizi, in the same field of endeavor, teaches (fig. 1) a hub 19 having an output port 11; an inner inflation shaft 30 to carry a gas, liquid or solution through the output port 11 (see [0083] and [0085]); the outer inflation shaft 32 to carry a gas, liquid or solution from the output port 11 (see [0083] and [0085]), the inner inflation shaft 30 coupled with a port 22 on the hub and the outer inflation shaft 32 coupled with a port 18 on the hub (see [0085]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran to have a hub having an output port ; the inner inflation shaft to carry a gas, liquid or solution through the output port; the outer inflation shaft to carry a gas, liquid or solution from the output port as taught by Zadno-Azizi, for the purpose of having all of the access points on one hub to make access for the user easier and having a strain relieving connector to reduce strain (see Zadno-Azizi [0087]).
Regarding claim 2, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran further discloses (fig. 1-4) the distal balloon 58 is positioned a third distance from the proximal balloon 19 owing to the second length of the flexible outer inflation shaft 16 being shorter than the first length of the flexible inner inflation shaft 51 (see fig. 1), wherein a segment of the flexible inner inflation shaft along a length of the third distance, or a portion thereof, allows for the flexible inner inflation shaft to bend or transition with respect to a position of the proximal balloon in a curved, U- or S-shaped configuration as the distal balloon, the flexible inner inflation shaft to which the distal balloon is coupled, and the proximal balloon traverse a vein or artery. The language “a segment of the flexible inner inflation shaft along a length of the third distance, or a portion thereof, allows for the flexible inner inflation shaft to bend or transition with respect to a position of the proximal balloon in a curved, U- or S-shaped configuration as the distal balloon, the flexible inner inflation shaft to which the distal balloon is coupled, and the proximal balloon traverse a vein or artery” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Imran as modified meets the structural limitations of the claim, and the segment of the flexible inner inflation shaft along a length of the third distance, or a portion thereof, is capable of allowing for the flexible inner inflation shaft to bend or transition with respect to a position of the proximal balloon in a curved, U- or S-shaped configuration as the distal balloon, the flexible inner inflation shaft to which the distal balloon is coupled, and the proximal balloon traverse a vein or artery. The segment of the flexible inner inflation shaft is flexible as the whole shaft is flexible therefore it is capable of bending.
Regarding claim 3, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran further discloses (fig. 1-4) the third distance is a fixed distance or a configurable distance (see fig. 1).
Regarding claim 9, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran as modified further teaches the hub further comprises a guidewire port 47, through which a guidewire 46 can be inserted to pass through the hub and output port and extend inside along the length of flexible inner inflation shaft (see Imran fig. 1). Imran is modified to have the ports on a hub such that the shafts pass through an output port.
Regarding claim 15, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran further discloses (fig. 1-4) the inner inflation shaft to carry the gas, liquid or solution that enters the distal balloon inflation port and flows from the output port to the distal balloon to inflate the distal balloon and the outer inflation shaft to carry the gas, liquid or solution, that enters the proximal balloon inflation port and flows from the output port to the proximal balloon (see claim 1 above) to inflate the proximal balloon at concurrent, overlapping, or non-overlapping time periods. The language “to inflate the distal balloon …to inflate the proximal balloon at concurrent, overlapping, or non-overlapping time periods” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Imran as modified meets the structural limitations of the claim, and the device is capable of inflating the distal and proximal balloons at concurrent, overlapping, or non-overlapping time periods. The distal and proximal balloons are inflated through separate inflation lumens therefore they are capable of inflating at concurrent, overlapping, or non-overlapping time periods.
Regarding claim 19, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran further discloses (fig. 1-4) the distal balloon and proximal balloon are inflated independent of each other (the distal and proximal balloons are inflated through separate inflation lumens, see fig. 1, col. 3 ln. 54-65 and col. 4 ln. 51-65).
Regarding claim 20, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran further discloses (fig. 1-4) the distal balloon and the proximal balloon are inflated at one of simultaneous, concurrent, overlapping, and non-overlapping time periods. The language “the distal balloon and the proximal balloon are inflated at one of simultaneous, concurrent, overlapping, and non-overlapping time periods” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Imran as modified meets the structural limitations of the claim, and the distal balloon and the proximal balloon are capable of being inflated at one of simultaneous, concurrent, overlapping, and non-overlapping time periods. The distal and proximal balloons are inflated through separate inflation lumens therefore they are capable of inflating at concurrent, overlapping, or non-overlapping time periods.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Zadno-Azizi as applied to claim 3 above, further in view of Cope et al. (US 20200129742 A1).
Regarding claim 4, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 3. Imran as modified is silent regarding the segment comprises one or more markers affixed to the inner inflation shaft to indicate a location of the segment while inserted in a vein or artery of a body.
However Cope, in the same filed of endeavor, teaches that a segment between the proximal and distal balloon comprises one or more markers affixed to the inner inflation shaft to indicate a location of the segment while inserted in a vein or artery of a body (see [0062]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran as modified to have the segment comprises one or more markers affixed to the inner inflation shaft to indicate a location of the segment while inserted in a vein or artery of a body as taught by Cope, for the purpose of being able to determine the location of the balloons and space therebetween (see Cope [0062]).
Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Zadno-Azizi as applied to claim 1 above, further in view of Berger et al. (US 20130345628 A1).
Regarding claims 5 and 8, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 3. Imran further discloses (fig. 1-4) an innermost shaft 31 coaxially aligned with and inside the inner inflation shaft 51, extending along the length of inner inflation shaft (see fig. 1).
Imran as modified is silent regarding a coil coaxially aligned with and inside the flexible inner inflation shaft; the innermost shaft houses the coil.
However Berger, in the same field of endeavor, teaches (fig. 14 and 16) an innermost shaft 31 housing a coil 8 which is coaxially aligned with and inside a inflation shaft 30 (see fig. 14 and [0122]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran as modified to have a coil coaxially aligned with and inside the flexible inner inflation shaft; the innermost shaft houses the coil as taught by Berger, for the purpose of being able to reduce deformation of the wall when fluid is delivered through the inflation lumen (see Berger [0122]).
Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Zadno-Azizi and Berger as applied to claim 5 above, and further in view of Eder (US 20050234427 A1).
Regarding claims 6 and 7, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 5. Imran further discloses (fig. 1-4) both balloons can be independently inflated and deflated and either balloon can be interchangeably serves as occlusion balloon to block blood flow and to remove the implanted stents or other implanted material inside the arteries or vein. The language “both balloons can be independently inflated and deflated and either balloon can be interchangeably serves as occlusion balloon to block blood flow and to remove the implanted stents or other implanted material inside the arteries or vein” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Imran as modified meets the structural limitations of the claim, and the both balloons are capable of being independently inflated and deflated and either balloon can be interchangeably serves as occlusion balloon to block blood flow and to remove the implanted stents or other implanted material inside the arteries or vein. The distal and proximal balloons are inflated through separate inflation lumens therefore they are capable of performing the claimed function.
Imran is silent regarding the coil comprises a radiopaque material, the radiopaque material comprises platinum.
However Eder, in the same filed of endeavor, teaches embedded coils in catheters can be made from radiopaque materials (see [0030]), the radiopaque material comprises platinum (see [0030]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran as modified to have the coil comprises a radiopaque material, the radiopaque material comprises platinum as taught by Eder, for the purpose of being able to visualize the coil under imaging (see Eder [0030]).
Claims 10 and 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Zadno-Azizi as applied to claim 1 above, further in view of Uflacker et al. (US 20060173487 A1).
Regarding claims 10, 13, and 14, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran as modified is silent regarding one or more scoring wires affixed to an outer surface of one or both of the distal balloon and the proximal balloon so that when the gas, liquid or solution inflates one or both of the distal balloon and the proximal balloon, the one or more scoring wires engages and cuts through material in a vein or artery in which the distal balloon and proximal balloon is situated; the scoring wire is selected from a group consisting of: an alloy of nickel titanium material, a metallic material, a composite material, and a polymer material; one or more scoring wires affixed to an outer surface of a portion of the flexible inner inflation shaft between the distal balloon and the proximal balloon.
However Uflacker, in the same filed of endeavor, teaches (fig. 1-3) one or more scoring wires 30 affixed to an outer surface of a balloon 16 (see fig. 2) so that when the gas, liquid or solution inflates the balloon, the one or more scoring wires engages and cuts through material in a vein or artery in which the balloon is situated (see fig. 2 and [0034]); the scoring wire 30 is selected from a group consisting of: an alloy of nickel titanium material, a metallic material, and a polymer material (see [0035]); one or more scoring wires 30 affixed to an outer surface of a portion of an inflation shaft 14 (via 24, see fig. 1-3 and [0030]-[0031]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran as modified to have one or more scoring wires affixed to an outer surface of the treatment balloon (distal balloon) so that when the gas, liquid or solution inflates the distal balloon, the one or more scoring wires engages and cuts through material in a vein or artery in which the distal balloon is situated; the scoring wire is selected from a group consisting of: an alloy of nickel titanium material, a metallic material, a composite material, and a polymer material; one or more scoring wires affixed to an outer surface of a portion of the inflation shaft of the distal balloon as taught by Uflacker, for the purpose of having a more effective treatment of stenosis by being able to cut through the plaque (see Uflacker [0034]).
Imran as modified teaches the one or more scoring wires affixed to an outer surface of a portion of the flexible inner inflation shaft between the distal balloon and the proximal balloon. Imran is modified to have one or more scoring wires affixed to an outer surface of a portion of the flexible inner inflation shaft and that portion is between the distal balloon and the proximal balloon.
Regarding claim 12, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Imran as modified further teaches the proximal balloon (19 of Imran) is maintained in an inflated state to occlude blood flow while the scoring wires of the distal balloon (modified balloon 58 of Imran to have the scoring wires) engage and cut through and loosen material adhering to the vein or artery to block the material from flowing past the proximal balloon (see Imran fig. 1 and Uflacker [0034]).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Zadno-Azizi as applied to claim 1 above, further in view of Bagaoisan et al. (US 20150174379 A1).
Regarding claim 16, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran further discloses (fig. 1-4) the guidewire input port 47 functions as a dialysis output port. The language “functions as a dialysis output port” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Imran as modified meets the structural limitations of the claim, and the guidewire input port is capable of functioning as a dialysis output port. The guidewire input port is an open port extending all the way to an open distal end of the device.
Imran as modified is silent regarding the hub further comprising a dialysis input port, and a return blood flow shaft coupled to the dialysis input port and affixed to an outer surface of the flexible outer inflation shaft, having a third length shorter than the second length and an return blood flow shaft output port via which blood flows in a vein.
However Bagaoisan, in the same filed of endeavor, teaches (fig. 1A) a hub further comprising a dialysis input port 107, and a return blood flow shaft 102 coupled to the dialysis input port 107 (see [0097]) and affixed to an outer surface of an inflation shaft 103 (see fig. 1A and [0097], having a third length shorter than a second length of 103 (see fig. 1A) and an return blood flow shaft output port 105 via which blood flows in a vein (see fig. 1A and [0094]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran as modified to have the hub further comprising a dialysis input port, and a return blood flow shaft coupled to the dialysis input port and affixed to an outer surface of the flexible outer inflation shaft, having a third length shorter than the second length and an return blood flow shaft output port via which blood flows in a vein as taught by Bagaoisan, for the purpose of being able to deliver fluid into the body to provide additional treatment to the body (see Bagaoisan abstract).
Claims 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Zadno-Azizi as applied to claim 1 above, further in view of Forman et al. (US 20030036726 A1).
Regarding claims 17 and 18, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran as modified is silent regarding the distal balloon comprises a distal end and a proximal end that coincides with a respective pair of markers affixed to the inner inflation shaft to indicate a location of the distal balloon while inserted in a vein or artery of a body; the proximal balloon comprises a distal end and a proximal end that coincides with a respective pair of proximal balloon markers affixed to the outer inflation shaft to indication a location of the proximal balloon while inserted in a vein or artery of a body.
However Forman, in the same filed of endeavor, teaches (fig. 2) a distal balloon 20 comprises a distal end and a proximal end that coincides with a respective pair of markers 54 affixed to an inner inflation shaft 12 to indicate a location of the distal balloon 20 while inserted in a vein or artery of a body (see fig. 2 and [0075]); a proximal balloon 24 comprises a distal end and a proximal end that coincides with a respective pair of proximal balloon markers 54 affixed to an outer inflation shaft 14 to indication a location of the proximal balloon 24 while inserted in a vein or artery of a body (see fig. 2 and [0075]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran as modified to have the distal balloon comprises a distal end and a proximal end that coincides with a respective pair of markers affixed to the inner inflation shaft to indicate a location of the distal balloon while inserted in a vein or artery of a body; the proximal balloon comprises a distal end and a proximal end that coincides with a respective pair of proximal balloon markers affixed to the outer inflation shaft to indication a location of the proximal balloon while inserted in a vein or artery of a body as taught by Forman, for the purpose of being able to being able to detect the position of the balloons and shafts during treatment (see Forman [0075]).
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over an alternate interpretation of Imran in view of Zadno-Azizi.
Regarding claim 1 Imran discloses (fig. 1-4) a medical device, comprising:
a distal balloon inflation port 42 (see col. 4 ln. 20-38), and a proximal balloon inflation port 62 (see fig. 1 and col. 4 ln. 51-65);
a distal balloon 36;
a flexible inner inflation shaft 31 (see col. 4 ln. 7-19) having a first length (see fig. 1), a proximal end coupled to the distal balloon inflation port 42 (see col. 4 ln. 20-38), and a distal end coupled to the distal balloon 36 (see fig. 1 and col. 4 ln. 20-38), the inner inflation shaft 31 to carry a gas, liquid or solution that enters the distal balloon inflation port to the distal balloon to inflate the distal balloon 36 (see col. 4 ln. 20-38);
a proximal balloon 58; and
a flexible outer inflation shaft 51 (see col. 4 ln. 44-50) surrounding and coaxially aligned with the inner inflation shaft 31 (see fig. 1 and 4) and having a second length shorter than the first length (see fig. 1), a proximal end coupled to the proximal balloon inflation port 62 (see col. 4 ln. 51-65), and a distal end coupled to the proximal balloon 58 (see fig. 1 and col. 4 ln. 51-65), the outer inflation shaft 16 to carry a gas, liquid or solution that enters the proximal balloon inflation port to the proximal balloon to inflate the proximal balloon 58 (see col. 4 ln. 51-65).
Imran is silent regarding a hub having an output port; the inner inflation shaft to carry a gas, liquid or solution through the output port; the outer inflation shaft to carry a gas, liquid or solution from the output port.
However Zadno-Azizi, in the same field of endeavor, teaches (fig. 1) a hub 19 having an output port 11; an inner inflation shaft 30 to carry a gas, liquid or solution through the output port 11 (see [0083] and [0085]); the outer inflation shaft 32 to carry a gas, liquid or solution from the output port 11 (see [0083] and [0085]), the inner inflation shaft 30 coupled with a port 22 on the hub and the outer inflation shaft 32 coupled with a port 18 on the hub (see [0085]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran to have a hub having an output port; the inner inflation shaft to carry a gas, liquid or solution through the output port; the outer inflation shaft to carry a gas, liquid or solution from the output port as taught by Zadno-Azizi, for the purpose of having all of the access points on one hub to make access for the user easier and having a strain relieving connector to reduce strain (see Zadno-Azizi [0087]).
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Imran in view of Zadno-Azizi as applied to the alternate interpretation of claim 1 above, further in view of Uflacker.
Regarding claim 10, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Imran as modified is silent regarding one or more scoring wires affixed to an outer surface of one or both of the distal balloon and the proximal balloon so that when the gas, liquid or solution inflates one or both of the distal balloon and the proximal balloon, the one or more scoring wires engages and cuts through material in a vein or artery in which the distal balloon and proximal balloon is situated.
However Uflacker, in the same filed of endeavor, teaches (fig. 1-3) one or more scoring wires 30 affixed to an outer surface of a balloon 16 (see fig. 2) so that when the gas, liquid or solution inflates the balloon, the one or more scoring wires engages and cuts through material in a vein or artery in which the balloon is situated (see fig. 2 and [0034]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Imran as modified to have one or more scoring wires affixed to an outer surface of the treatment balloon (proximal balloon) so that when the gas, liquid or solution inflates the proximal balloon, the one or more scoring wires engages and cuts through material in a vein or artery in which the proximal balloon is situated as taught by Uflacker, for the purpose of having a more effective treatment of stenosis by being able to cut through the plaque (see Uflacker [0034]).
Regarding claim 11, Imran as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Imran as modified further teaches the distal balloon (36 of Imran) is maintained in an inflated state to occlude blood flow while the scoring wires of the proximal balloon (modified balloon 58 of Imran to have the scoring wires) engage and cut through and loosen material adhering to the vein or artery to block the material from flowing past the proximal balloon (see Imran fig. 1 and Uflacker [0034]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771