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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/3/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 11 and 21 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, Grace is no longer relied upon to disclose the amended limitations pertaining to the outer layer of the balloon.
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) 1-2, 5-7, 9-10, 21 and 39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan (US 7691119 B2)( previously of record) in view of Rudakov (US 2007/0100426 A1)(previously of record), further in view of Davies (US 2015/0151092 A1).
Regarding claim 1, Farnan discloses:
A medical apparatus (see Fig. 1 for reference, relying on the stent arrangement shown in the embodiment of Fig. 10), comprising:
a balloon (balloon 1, see Fig. 1) including a central portion and first and second tapered portions connected to the central portion (see Examiner’s Diagram of Farnan Fig. 10 below showing a central portion and two adjacent tapered portions), the balloon including a longitudinal axis (axis passing through the center of the device); and
a single continuous fiber (wires 5 which are all interconnected together to form a single, continuous wire with no breaks; see Fig. 1 for reference, relying on the embodiment of Fig. 10 for the desired configuration of the wire stent) extending longitudinally along the balloon (see Fig. 10), the single continuous fiber having a first turnaround point, a second turnaround point, and a third turnaround point (see Examiner’s Diagram of Farnan Fig. 10 below showing a first, second and third turnaround point);
wherein at each of the first, second, and third turnaround points, the fiber is not wrapped around the balloon (at each of the three turnaround points, the fiber only extends along a portion of the circumference of the balloon rather than the entire circumference thereof, seen to be similar to Fig. 2 of the claimed invention wherein, at the turnaround points, the wire changes direction over a portion of the circumference); and
wherein an entirety of the single continuous fiber is attached to an outer surface of the balloon (see Fig. 10 showing wherein the wires are attached to the outer surface of the balloon, see also Col. 3, Lines 1-7 mentioning wherein an adhesive is used to tack the struts to the balloon, thus ensuring the entirety of the stent is attached to the balloon as the adhesive prevents removal therefrom).
However, Farnan does not expressly disclose:
an outer layer wrapped around the balloon and covering the single continuous fiber; and
wherein the first turnaround point is located in the first tapered region, wherein the second turnaround point is located in the second tapered portion and wherein the third turnaround point is located in the first tapered portion. Rather, the first and third turnaround points are adjacent the first tapered portion and the second turnaround is adjacent the second tapered portion.
In the same field of endeavor, namely balloon catheters comprising cutting/scoring elements disposed along an outer surface thereof configured to cut or score tissue, Davies teaches a cutting/scoring balloon catheter (see Fig. 21 and Para. [0118], [126]-[0128]) comprising a balloon (balloon 10, see Fig. 1A and 21) having a plurality of scoring elements disposed along the surface thereof (rods 124, see Fig. 21 and Para. [0118], [0126]-[0128]) configured to cut or score tissue and/or plaque (see Para. [0126]-[0127]); wherein an outer polymeric film layer is applied over the outer surface of the balloon and cutting/scoring elements (see Para. [0117]) which provides superior burst strength and abrasion and puncture resistance (see Para. [0081]).
Since the stent frame of Farnan is non-deployable and affixed to the outer surface of the balloon while being configured to cut tissue in atherectomy procedures, the balloon of Farnan is understood to reasonably constitute an angioplasty cutting balloon and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the outer surface of the balloon, including the stent wires disposed thereon, to be coated with an outer polymeric film layer as taught and suggested by Davies to, in this case, provide superior burst strength and abrasion and puncture resistance (see Davies Para. [0081]).
In the same field of endeavor, namely stent delivery balloon devices, Rudakov teaches a balloon catheter (see Fig. 4) configured to carry a stent overtop of a balloon (see Fig. 4 showing wherein stent 112 lies over top of the balloon), wherein the stent comprises turnaround points in the tapered portions on either side of the balloon (see Examiner’s Diagram of Rudakov Fig. 4 below showing wherein the stent comprises turnaround points in the tapered region of the balloon where the stent changes direction).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known stent arrangement for another (see KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of having the turnaround points of the stent of Farnan be in the tapered portions of the balloon device as disclosed by Rudakov, since Rudakov illustrates that it is known in the art to configure the turnaround points of a stent to lie over the tapered portions of the delivery balloon. As none of Farnan or Rudakov provide any criticality to the location of the turnaround points, one of ordinary skill in the art would have expected the stent to operate equally well with turnaround points in either the central portion of the balloon, or in the tapered portions of the balloon, since both configurations have been shown to have been present in the art before the effective filing date of the claimed invention without criticality to either configuration that would render the balloon catheter of Farnan non-functional should the turnaround points be located in a location other than the central body as shown in the disclosed figures.
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Examiner’s Diagram of Farnan Fig. 10
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Examiner’s Diagram of Rudakov Fig.4
Regarding claim 2, the combination of Farnan, Davies and Rudakov disclose the invention of claim 1, Farnan, as modified by Rudakov, further discloses wherein the single continuous fiber comprises:
a first pass running substantially parallel to the longitudinal axis along the central portion to the first turnaround point in the first tapered portion (see Examiner’s Diagram of Farnan Fig. 10_Turnaround below showing a first pass running substantially parallel to the longitudinal axis and connecting to the previously-identified first turnaround point);
a second pass running substantially parallel to the longitudinal axis along the central portion to the second turnaround point in the second tapered portion (see Examiner’s Diagram of Farnan Fig. 10_Turnaround below showing a second pass running substantially parallel to the longitudinal axis and connecting to the previously-identified second turnaround point – since the wires are all connected together, forming a single, continuous wire, all of the “passes” connect to all “turnaround points” via at least an indirect connection since all of the wires form a single structure).
a third pass running substantially parallel to the longitudinal axis along the central portion to the third turnaround point in the first tapered portion (see Examiner’s Diagram of Farnan Fig. 10_Turnaround below showing a third pass running substantially parallel to the longitudinal axis and connecting to the previously-identified third turnaround point - the “third pass” is understood to be on the opposing side of the device not shown in Fig. 10_Turnaround but understood to be present unless otherwise stated since anywhere between 3-12 wires are present over the length of the balloon – see Farnan Col. 2, Lines 42-45).
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Examiner’s Diagram of Farnan Fig. 10_Turnaround
Regarding claim 5, the combination of Farnan, Davies and Rudakov disclose the invention of claim 1, Farnan, as modified by Rudakov, further discloses wherein the first turnaround point is adjacent an end of the first tapered portion (the first turnaround point of Farnan, as modified by Rudakov to be located within the first tapered portion, is adjacent to an end of the first tapered portion due to the location of the first turnaround point within the first tapered portion and adjacent to both ends thereof– see Rudakov Fig. 4 above for reference in terms of location once incorporated into the device of Farnan).
Regarding claim 6, the combination of Farnan, Davies and Rudakov disclose the invention of claim 1, Farnan, as modified by Rudakov, further discloses wherein the first turnaround point is adjacent a transition from the central portion to the first tapered portion (the first turnaround point of Farnan, as modified by Rudakov to be located within the first tapered portion, is adjacent to the transition from the central portion to the first tapered portion due to the location of the first turnaround point within the first tapered portion, which itself is adjacent to the transition from the central portion).
Regarding claim 7, the combination of Farnan, Davies and Rudakov disclose the invention of claim 1, Farnan further discloses an adhesive adhering the single continuous fiber to an outer surface of the balloon. (see Col. 3, Lines 1-7).
Regarding claim 9, the combination of Farnan, Davies and Rudakov disclose the invention of claim 1, Farnan further discloses wherein the first and third turnaround points are aligned in a circumferential direction (since the first and third turnaround points are both troughs (i.e., closer to the center of the balloon than the peaks which are further from the center of the balloon) along the undulating wire disposed circumferentially at the first tapered portion, both turnaround points are understood to be circumferentially aligned with one-another (i.e., not staggered)).
Regarding claim 10, the combination of Farnan, Davies and Rudakov disclose the invention of claim 1, Farnan further discloses wherein the first and second turnaround points are offset in a circumferential direction (see Examiner’s Diagram of Farnan Fig. 10_Turnaround above showing wherein the first turnaround point and second turnaround points offset from one-another since the second turnaround point is offset from the “first pass” which runs parallel along the longitudinal axis from the first turnaround point).
Regarding claim 21, Farnan discloses:
A medical apparatus (see Fig. 1 for reference, relying on the stent arrangement shown in the embodiment of Fig. 10), comprising:
a balloon (balloon 1, see Fig. 1) including a central portion, first and second tapered portions connected to the central portion, and end portions (see Examiner’s Diagram of Farnan Fig. 10 below showing a central portion and two adjacent tapered portions), the balloon having a longitudinal axis (axis passing through the center of the device);
a single continuous fiber (wires 5 which are all interconnected together to form a single, continuous wire with no breaks, see Fig. 1 for reference, relying on the embodiment of Fig. 10 for the desired configuration of the wire stent) extending longitudinally along the balloon (see Fig. 10), the single continuous fiber having a first turnaround point, a second turnaround point and a third turnaround point (see Examiner’s Diagram of Farnan Fig. 10 below showing a first, second and third turnaround points);
wherein the first and third turnaround points are staggered along the longitudinal axis (see Examiner’s Diagram of Farnan Fig. 10 below showing wherein the exemplary first and third turnaround points are staggered along the longitudinal axis since the first turnaround point is a trough (i.e., closer to the center of the balloon) and the third turnaround point is a peak (i.e., further from the center of the balloon) along the undulation section of wire encircling the circumference of the balloon at the first tapered portion); and
wherein an entirety of the single continuous fiber is attached to an outer surface of the balloon (see Fig. 10 showing wherein the wires are attached to the outer surface of the balloon, see also Col. 3, Lines 1-7 mentioning wherein an adhesive is used to tack the struts to the balloon, thus ensuring the entirety of the stent is attached to the balloon as the adhesive prevents removal therefrom).
However, Farnan does not expressly disclose:
wherein the apparatus further includes an outer layer comprising a panel of film wrapped around the balloon and covering the single continuous fiber; and
wherein the first turnaround point is located in the first tapered region, wherein the second turnaround point is located in the second tapered portion and wherein the third turnaround point is located in the first tapered portion. Rather, the first and third turnaround points are adjacent the first tapered portion and the second turnaround is adjacent the second tapered portion.
In the same field of endeavor, namely balloon catheters comprising cutting/scoring elements disposed along an outer surface thereof configured to cut or score tissue, Davies teaches a cutting/scoring balloon catheter (see Fig. 21 and Para. [0118], [126]-[0128]) comprising a balloon (balloon 10, see Fig. 1A and 21) having a plurality of scoring elements disposed along the surface thereof (rods 124, see Fig. 21 and Para. [0118], [0126]-[0128]) configured to cut or score tissue and/or plaque (see Para. [0126]-[0127]); wherein an outer polymeric film layer is applied over the outer surface of the balloon and cutting/scoring elements (see Para. [0117]) which provides superior burst strength and abrasion and puncture resistance (see Para. [0081]).
Since the stent frame of Farnan is non-deployable and affixed to the outer surface of the balloon while being configured to cut tissue in atherectomy procedures, the balloon of Farnan is understood to reasonably constitute an angioplasty cutting balloon and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the outer surface of the balloon, including the stent wires disposed thereon, to be coated with an outer polymeric film layer as taught and suggested by Davies to, in this case, provide superior burst strength and abrasion and puncture resistance (see Davies Para. [0081]).
In the same field of endeavor, namely stent delivery balloon devices, Rudakov teaches wherein a balloon catheter (see Fig. 4) configured to carry a stent overtop of a balloon (see Fig. 4 showing wherein stent 112 lies over top of the balloon), wherein the stent comprises turnaround points in the tapered portions on either side of the balloon (see Examiner’s Diagram of Rudakov Fig. 4 below showing wherein the stent comprises turnaround points in the tapered region of the balloon).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of having the turnaround points of the stent of Farnan be in the tapered portions of the balloon device as disclosed by Rudakov, since Rudakov illustrates that it is known in the art to configure the turnaround points of a stent to lie over the tapered portions of the delivery balloon. As none of Farnan or Rudakov provide any criticality to the location of the turnaround points, one of ordinary skill in the art would have expected the stent to operate equally well with turnaround points in either the central portion of the balloon, or in the tapered portions of the balloon, since both configurations have been shown to have been present in the art before the effective filing date of the claimed invention without criticality to either configuration that would render the balloon catheter of Farnan non-functional should the turnaround points be located in a location other than the central body as shown in the disclosed figures.
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Examiner’s Diagram of Farnan Fig. 10
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Examiner’s Diagram of Rudakov Fig.4
Regarding claim 39, the combination of Farnan, Davies and Rudakov disclose the invention of claim 1, Farnan further discloses wherein the balloon comprises first and second reduced diameter necks adjacent to the first and second tapered portions, respectively (see Examiner’s Diagram of Farnan Fig. 10_Necks below showing wherein the balloon comprises a first and second reduced diameter neck portion at terminal ends of the respective first and second tapered portions), the first and second the reduced diameter necks being free of fiber (no wires extend into the terminal ends of the balloon since the wires only extend into the tapered portions, as modified by Rudakov, and thus no wires are present at the terminal neck portions of the balloon).
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Examiner’s Diagram of Farnan Fig. 10_Necks
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan (US 7691119 B2)(previously of record), in view of Rudakov (US 2007/0100426 A1)(previously of record), further in view of Davies (US 2015/0151092 A1), further in view of Fischell (US 2003/0050688 A1)(previously of record).
Regarding claim 3 the combination of Farnan, Davies and Rudakov disclose all of the limitations of the invention of claim 1.
However, Farnan does not expressly disclose wherein the third turnaround point is spaced from the first turnaround point along the longitudinal axis (i.e., in a staggered configuration).
However, in the same field of endeavor, namely stent devices configured to fit over a balloon, Fischell teaches wherein a stent configured to fit over a balloon (see Fig. 3B) may comprise turnaround points at opposing ends of the stent (see Fig. 3B), wherein adjacent turnaround points are offset from one-another along the longitudinal axis (see Fig. 3B) to allow a user to more easily align and place the stent in a branch vessel that is at an angle to the main delivery vessel (see Para. [0008], see also Fig. 5B).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified adjacent turnaround points from the device of Farnan to be offset from one-another along the longitudinal axis so that, when the stent is utilized to be placed or inserted within a branch vessel, the stent will more easily align with the offset angle of the branch vessel relative to the main delivery vessel during a follow-up procedure (see Fischell Para. [0008]).
Regarding claim 4, the combination of Farnan, Davies, Rudakov and Fischell disclose the invention of claim 3, Farnan further discloses a fourth turnaround point in the second tapered portion and spaced from the first turnaround point along the longitudinal axis (see Examiner’s Diagram of Farnan Fig. 10_Fourth below showing a fourth turnaround point located in the second tapered portion and offset from the first turnaround point along the longitudinal axis).
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Examiner’s Diagram of Farnan Fig. 10_Fourth
Claim(s) 11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan (US 7691119 B2)(previously of record) in view of Hanson (US 2006/0248698 A1)(previously of record), further in view of Davies (US 2015/0151092 A1).
Regarding claim 11, Farnan discloses:
A medical apparatus (see Fig. 1 for reference, relying on the stent arrangement shown in the embodiment of Fig. 10), comprising:
a balloon (balloon 1, see Fig. 1) including a balloon wall (outer surface of the balloon, see Fig. 1) forming a central portion, first and second tapered portions connected to the central portion (see Examiner’s Diagram of Farnan Fig. 10 below showing a central portion and two adjacent tapered portions as part of the outer surface of the balloon), and a reduced diameter end portion connected to each of the first and second tapered portions (see Examiner’s Diagram of Farnan Fig. 10 below showing wherein a reduced diameter portion is present on the terminal ends of the balloon adjacent the respective first and second tapered portions), the balloon having a longitudinal axis (axis passing through the center of the device); and
wherein the balloon wall comprises a single continuous fiber (wires 5 which are all interconnected together to form a single, continuous wire with no breaks, see Fig. 1 for reference, relying on the embodiment of Fig. 10 for the desired configuration of the wire stent attached to the outer surface of the balloon as recited in Col. 3, Lines 1-7) extending longitudinally along the central portion (see Fig. 10) and the first and second tapered portions in a repeating manner (see Fig. 10), but not extending along or around the reduced diameter end portions of the balloon (see Fig. 10 showing wherein the wires do not extend beyond the central portion of the balloon).
However, Farnan does not expressly disclose:
wherein the balloon wall further comprises an outer layer comprising a film covering the balloon and the single continuous fiber; and
wherein the single continuous fiber does not wrap fully around the balloon.
In the same field of endeavor, namely balloon catheters comprising cutting/scoring elements disposed along an outer surface thereof configured to cut or score tissue, Davies teaches a cutting/scoring balloon catheter (see Fig. 21 and Para. [0118], [126]-[0128]) comprising a balloon (balloon 10, see Fig. 1A and 21) having a plurality of scoring elements disposed along the surface thereof (rods 124, see Fig. 21 and Para. [0118], [0126]-[0128]) configured to cut or score tissue and/or plaque (see Para. [0126]-[0127]); wherein an outer polymeric film layer is applied over the outer surface of the balloon and cutting/scoring elements (see Para. [0117]) which provides superior burst strength and abrasion and puncture resistance (see Para. [0081]).
Since the stent frame of Farnan is non-deployable and affixed to the outer surface of the balloon while being configured to cut tissue in atherectomy procedures, the balloon of Farnan is understood to reasonably constitute an angioplasty cutting balloon and it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the outer surface of the balloon, including the stent wires disposed thereon, to be coated with an outer polymeric film layer as taught and suggested by Davies to, in this case, provide superior burst strength and abrasion and puncture resistance (see Davies Para. [0081]).
In the same field of endeavor, namely stent devices configured to be expanded and contracted, Hanson teaches wherein forming a stent in a “C-shaped” manner (see Fig. 7) with a cut-out along the long axis of the stent, forming a radially-discontinuous shape (see Fig. 7) allows the stent to be more easily readily expanded within a lumen before returning to a collapsed configuration (see Para. [0043]).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the stent of Farnan to comprise a “C-Shape” having a longitudinally extending cut along the length thereof, as taught and suggested by Hanson, since this shape is disclosed to provide an easier transition between an expanded and collapsed state (see Hanson Para. [0043]).
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Examiner’s Diagram of Farnan Fig. 10
Regarding claim 17, the combination of Farnan, Davies and Hanson disclose the invention of claim 11, Farnan further discloses an adhesive adhering the single continuous fiber to an outer surface of the balloon. (see Col. 3, Lines 1-7).
Claim(s) 12, 15-16, 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan (US 7691119 B2)(previously of record) in view of Hanson (US 2006/0248698 A1)(previously of record), further in view of Davies (US 2015/0151092 A1), further in view of Rudakov (US 2007/0100426 A1)(previously of record).
Regarding claim 12, the combination of Farnan, Davies and Hanson disclose the invention of claim 11, Farnan further discloses:
wherein the single continuous fiber comprises a first turnaround point, a second turnaround point and a third turnaround point (see Examiner’s Diagram of Fig. 10_Turnaround below defining a first turnaround point adjacent the first tapered portion, a second turnaround point adjacent the second tapered portion and a third turnaround point adjacent the first tapered portion);
wherein the single continuous fiber comprises:
a first pass running substantially parallel to the longitudinal axis along the central portion to the first turnaround point (see Examiner’s Diagram of Farnan Fig. 10_Turnaround below showing a first pass running substantially parallel to the longitudinal axis and connecting to the defined first turnaround point);
a second pass running substantially parallel to the longitudinal axis along the central portion to a second turnaround point (see Examiner’s Diagram of Farnan Fig. 10_Turnaround below showing a second pass running substantially parallel to the longitudinal axis and connecting to the defined second turnaround point – since the wires are all connected together, forming a single, continuous wire, all of the “passes” connect to all “turnaround points” via at least an indirect connection since all of the wires form a single structure); and
a third pass running substantially parallel to the longitudinal axis along the central portion to a third turnaround point (see Examiner’s Diagram of Farnan Fig. 10_Turnaround below showing a third pass running substantially parallel to the longitudinal axis and connecting to the previously-identified third turnaround point - the “third pass” is understood to be on the opposing side of the device not shown in Fig. 10_Turnaround but understood to be present unless otherwise stated since anywhere between 3-12 wires are present along the length of the balloon– see Farnan Col. 2, Lines 42-45).
However, Farnan does not expressly disclose wherein the first and third turnaround points are located in the tapered portion and wherein the second turnaround point is located in the second tapered portion.
However, in the same field of endeavor, namely stent delivery balloon devices, Rudakov teaches wherein a balloon catheter (see Fig. 4) configured to carry a stent overtop of a balloon (see Fig. 4 showing wherein stent 112 lies over top of the balloon), wherein the stent comprises turnaround points in the tapered portions on either side of the balloon (see Examiner’s Diagram of Rudakov Fig. 4 below showing wherein the stent comprises turnaround points in the tapered region of the balloon).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known stent arrangement for another (see KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 398, 82 USPQ2d 1385 (2007)) to have obtained the predictable result of having the turnaround points of the stent of Farnan be in the tapered portions of the balloon device as disclosed by Rudakov, since Rudakov illustrates that it is known in the art to configure the turnaround points of a stent to lie over the tapered portions of the delivery balloon. As none of Farnan or Rudakov provide any criticality to the location of the turnaround points, one of ordinary skill in the art would have expected the stent to operate equally well with turnaround points in either the central portion of the balloon, or in the tapered portions of the balloon, since both configurations have been shown to have been present in the art before the effective filing date of the claimed invention without criticality to either configuration that would render the balloon catheter of Farnan non-functional should the turnaround points be located in a location other than the central body as shown in the disclosed figures.
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Examiner’s Diagram of Fig. 10_Turnaround
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Examiner’s Diagram of Rudakov Fig.4
Regarding claim 15, the combination of Farnan, Davies, Hanson and Rudakov disclose the invention of claim 12, Farnan, as modified by Rudakov, further discloses wherein the first turnaround point is adjacent an end of the first tapered portion (the first turnaround point of Farnan, as modified by Rudakov to be located within the first tapered portion, is adjacent to an end of the first tapered portion due to the location of the first turnaround point within the first tapered portion and adjacent to both ends thereof– see Rudakov Fig. 4 above for reference in terms of location).
Regarding claim 16, the combination of Farnan, Davies, Hanson and Rudakov disclose the invention of claim 12, Farnan, as modified by Rudakov, further discloses wherein the first turnaround point is adjacent a transition from the central portion to the first tapered portion (the first turnaround point of Farnan, as modified by Rudakov to be located within the first tapered portion, is adjacent to the transition from the central portion to the first tapered portion due to the location of the first turnaround point within the first tapered portion, which itself is adjacent to the transition from the central portion).
Regarding claim 19, the combination of Farnan, Davies, Hanson and Rudakov disclose the invention of claim 12, Farnan further discloses wherein the first and third turnaround points are aligned in a circumferential direction (since the first and third turnaround points are both troughs (i.e., closer to the center of the balloon than the peaks which are further from the center of the balloon) along the undulating wire disposed circumferentially at the first tapered portion, both turnaround points are understood to be circumferentially aligned with one-another (i.e., not staggered)).
Regarding claim 20, the combination of Farnan, Davies, Hanson and Rudakov disclose the invention of claim 12, Farnan further discloses wherein the first and second turnaround points are offset in a circumferential direction (see Examiner’s Diagram of Farnan Fig. 10_Turnaround above showing wherein the first turnaround point and second turnaround points offset from one-another since the second turnaround point is offset from the “first pass” which runs parallel along the longitudinal axis from the first turnaround point).
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Farnan (US 7691119 B2)( previously of record), in view of Hanson (US 2006/0248698 A1)( previously of record), further in view of Davies (US 2015/0151092 A1), further in view of Rudakov (US 2007/0100426 A1)(previously of record), further in view of Fischell (US 2003/0050688 A1)( previously of record).
Regarding claim 13 the combination of Farnan, Davies, Hanson and Rudakov disclose all of the limitations of the invention of claim 12.
However, Farnan does not expressly disclose herein the third turnaround point is spaced from the first turnaround point along the longitudinal axis (i.e., in a staggered configuration).
However, in the same field of endeavor, namely stent devices configured to fit over a balloon, Fischell teaches wherein a stent configured to fit over a balloon (see Fig. 3B) may comprise turnaround points at opposing ends of the stent (see Fig. 3B), wherein adjacent turnaround points are offset from one-another along the longitudinal axis (see Fig. 3B) to allow a user to more easily align and place the stent in a branch vessel that is at an angle to the main delivery vessel (see Para. [0008], see also Fig. 5B).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified adjacent turnaround points from the device of Farnan to be offset from one-another along the longitudinal axis so that, when the stent is utilized to be placed or inserted within a branch vessel, the stent will more easily align with the offset angle of the branch vessel relative to the main delivery vessel during a follow-up procedure (see Fischell Para. [0008]).
Regarding claim 14, the combination of Farnan, Davies, Hanson, Rudakov and Fischell disclose the invention of claim 13, Farnan further discloses a fourth turnaround point in the second tapered portion and spaced from the first turnaround point along the longitudinal axis (see Examiner’s Diagram of Farnan Fig. 10_Fourth below showing a fourth turnaround point located in the second tapered portion and offset from the first turnaround point along the longitudinal axis).
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Examiner’s Diagram of Farnan Fig. 10_Fourth
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 11812987 B2 to Madej, US 2015/0297281 A1 to Sutermeister, US 2003/0163148 A1 to Wang and US 2007/0060863 A1 all disclose cutting balloon catheters that may comprise an exterior coating along the outside surface of the balloon and/or cutting elements.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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