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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 15 and 18 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.
Regarding claim 1, none of either Krolik (US 2010/0286593 A1) (previously of record), Erpen (US 2017/0056048 A1)(previously of record) or Chang (US 2019/0314620 A1) (previously of record) are relied upon to disclose or suggest the amended limitations of “a braid extending over and radially outward of at least part of the base portion”.
Regarding claim 15, none of either Krolik (US 2010/0286593 A1) (previously of record), Erpen (US 2017/0056048 A1) (previously of record) or Madej (US 2017/0056048 A1) (previously of record) are relied upon to disclose or suggest the amended limitations of “a braid extending over the outer surface” and “a blade including a base portion secured within the polymeric pad, the braid extending over and radially outward of at least part of the polymeric pad and/or at least part of the base portion”.
Regarding claim 18, none of either Krolik (US 2010/0286593 A1) (previously of record), Madej (US 2017/0056048 A1) (previously of record) or Chang (US 2019/0314620 A1) (previously of record) are relied upon to disclose or suggest the amended limitations of “a braid extending over the outer surface” and “a blade secured within the polymeric pad, the braid extending over and radially outward of at least part of the base portion”.
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 18-20 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 18 recites the limitation "the base portion" in the newly-amended claim language. There is insufficient antecedent basis for this limitation in the claim a no “base portion” has been previously defined, rendering the cited limitation indefinite. For the purposes of examination, “the base portion” is interpreted to recite “a base portion” until otherwise amended.
Claims 19-20 are additionally rendered indefinite due to their dependency from and further modification of claim 18.
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) 1-3 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Erpen (US 2017/0056048 A1)(previously of record), further in view of Bucino (US 2013/0116655 A1).
Regarding claim 1, Krolik discloses:
A medical device (apparatus 10; see Fig. 1), comprising:
a catheter shaft (catheter 20; see Fig. 1) including a distal region (portion of the catheter 20 upon which balloon 30 is disposed; see Fig. 1);
an inflatable balloon (balloon 30; see Fig. 1; see also Para. [0025]) secured to the distal region of the catheter shaft (see Fig. 1), the inflatable balloon having an outer surface (see Figs. 1 and 2), the inflatable balloon defining a centerline when inflated (centerline of the inflated balloon shown in Figs. 1-2); and
a blade extending over and secured to the outer surface (cutting features 40; see Figs. 1-3; see also Para. [0029]; see also Para. [0012] mentioning wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components), the blade including a base portion (proximal portion(s) of cutting features 40 in direct abutment with the outer surface of the balloon 30; see Figs. 2-3) and a blade portion extending outwardly from the base portion (distal pointed tips of cutting features 40; see Figs. 2-3); and
wherein the blade has a cutting edge extending from a distal end of the blade to a proximal end of the blade (see Figs. 1-3; see also Para. [0029]-[0031]).
However, while Krolik discloses wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), Krolik does not expressly disclose:
wherein, when the inflatable balloon is inflated, the cutting edge tapers from a maximum distance measured relative to a centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade; and additionally,
a braid extending over and radially outward of at least part of the base portion.
In the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Erpen teaches a balloon catheter (see Fig. 1) for use within the vasculature (see Para. [0005] and [0018]) comprising a plurality of cutting elements (cutting elements 3; see Figs. 1 and 4) disposed along the outer surface of the balloon (see Figs. 1 and 4), wherein the cutting elements comprise a height that tapers from a maximum distance measured relative to a centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade (see Figs. 1 and 4; see also Para. [0030]) to enable the cutting elements to gradually dig into the inner wall of the vessel to produce a less painful treatment (see Para. [0032] mentioning wherein the axially variably shape of the cutting elements is responsible for “gradually digging into the inner wall of the vein like a plough such that an abrupt mechanical effect is thus avoided so that a less painful treatment is possible which, in some circumstances, can even be carried out without local anesthetic in the form of a tumescent anesthetic”).
Since Krolik provides express disclosure of wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), 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 shape of the cutting features of Krolik to comprise a tapered profile in which the height of the cutting features decreases from a maximum distance measured relative to a centerline of the balloon at the distal end of the cutting feature to a minimum distance measured relative to the centerline of the balloon at the proximal end of the cutting feature as taught and suggested by Erpen to, in this case, provide a known alternative variable-height cutting feature/element shape that enables the cutting features/elements to gradually dig into the target occlusion within the vasculature while providing a less painful treatment (see Erpen Para. [0032]).
Additionally, in the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Bucino teaches a balloon catheter (balloon assembly 200; see Figs. 2B(1)-2B(3)) for use within the vasculature (see Para. [0005]-[0006], [0037] and [0078]; balloon assembly 200 is configured for use within the vasculature) comprising a plurality of cutting elements (protrusions 212; see Fig. 2B(4); see also Para. [0094]) disposed along the outer surface of the balloon (see Figs. 2B(1)-2B(4)); wherein the cutting elements include a base portion (proximal portion of protrusions 212 that are along the same axis as the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below) and a blade portion extending outwardly from the base portion (distal protruding portions of protrusions 212 that extend radially-outward from the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below); wherein the balloon catheter further comprises a braid extending over and radially outward of at least part of the base portion (braided template 220; see Fig. 2B(4); see also Para. [0088] and [0094]) which may be applied to the outer surface of the balloon to provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Para. [0012]-[0015] and [0124]).
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 inflatable balloon of Krolik to comprise a braided template layer disposed along the outer surface thereof and covering all elements directly attached thereto, leaving gaps for the tips of the cutting features, as taught and suggested by Bucino to, in this case, provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Bucino Para. [0012]-[0015] and [0124]).
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Examiner’s Diagram of Fig. 2B(4)
Regarding claim 2, the combination of Krolik, Erpen and Bucino disclose the invention of claim 1, Krolik further discloses wherein the cutting edge of the blade comprises a straight line (see Para. [0007] and [0030] mentioning wherein the cutting features extend axially along the balloon surface and are substantially parallel to the longitudinal axis of the device).
Regarding claim 3, the combination of Krolik, Erpen and Bucino disclose all of the limitations of the invention of claim 1.
However, while Krolik, as modified by the teachings of Erpen to comprise tapered cutting features, discloses wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Krolik Para. [0029]), none of either Krolik or Erpen expressly disclose wherein the minimum distance is in a range of 1 to 2 millimeters and the maximum distance is in a range of 2 to 4 millimeters.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the tapered cutting features of Krolik, as modified by Erpen, to have a minimum distance from the centerline be within a range of 1 to 2 millimeters and a maximum distance from the centerline be within a range of 2 to 4 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, since the cutting features of Krolik are already tapered along the lengths thereof (due to modification from the teachings of Erpen), the device of Krolik et al. would not operate differently with the claimed distance(s) from the centerline so long as the tapered profile is maintained. Additionally, since both the claimed invention and the devices of Krolik and Erpen are intended and configured to be sized to allow for insertion into the vasculature, the claimed invention and the devices of Krolik and Erpen would comprise similar workable dimensions for their shared operation site. Further, applicant places no criticality on the range claimed, indicating simply that the distances “may” be within the claimed ranges (see Specification Para. [0023], [0080], [0093] and [0098]).
Regarding claim 14, the combination of Krolik, Erpen and Bucino disclose the invention of claim 1, Krolik, as modified by Erpen, further discloses one or more additional blades (see Krolik Figs 1-2 showing a plurality of cutting features 40 disposed along the outer surface of the balloon; see also Krolik Para. [0029]), each of the one or more additional blades extending over and secured to the outer surface (see Krolik Fig. 1), each of the one or more additional blades having a cutting edge extending from a distal end of the blade to a proximal end of the blade (see Krolik Fig. 1; see also Krolik Para. [0029]), the cutting edge extending, when the inflatable balloon is inflated, from a maximum distance measured relative to a centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade (cutting features 40 of Krolik, as modified by the teachings of Erpen, have been modified such that the height of each cutting feature tapers from a maximum distance from the centerline of the balloon at the distal end thereof to a minimum distance from the centerline of the balloon at the proximal end thereof).
Claim(s) 1-2 and 10-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Chang (US 2019/0314620 A1) (previously of record), further in view of Bucino (US 2013/0116655 A1).
Regarding claim 1, Krolik discloses:
A medical device (apparatus 10; see Fig. 1), comprising:
a catheter shaft (catheter 20; see Fig. 1) including a distal region (portion of the catheter 20 upon which balloon 30 is disposed; see Fig. 1);
an inflatable balloon (balloon 30; see Fig. 1) secured to the distal region of the catheter shaft (see Fig. 1), the inflatable balloon having an outer surface (see Figs. 1 and 2), the inflatable balloon defining a centerline when inflated (centerline of the inflated balloon shown in Figs. 1-2); and
a blade extending over and secured to the outer surface (cutting features 40; see Figs. 1-3; see also Para. [0029]; see also Para. [0012] mentioning wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components), the blade including a base portion (proximal portion(s) of cutting features 40 in direct abutment with the outer surface of the balloon 30; see Figs. 2-3) and a blade portion extending outwardly from the base portion (distal pointed tips of cutting features 40; see Figs. 2-3); and
wherein the blade having a cutting edge extending from a distal end of the blade to a proximal end of the blade (see Figs. 1-3 and Para. [0029]-[0031]).
However, while Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), Krolik does not expressly disclose:
when the inflatable balloon is inflated, the cutting edge tapers from a maximum distance measured relative to a centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade, and additionally,
a braid extending over and radially outward of at least part of the base portion;
In the same field of endeavor, namely cutting balloon catheters configured to be inserted within a bodily space to cut and remove debris (e.g., lesions, polyps, enlarged or abnormal tissue, etc.) therefrom, Chang teaches a cutting balloon catheter (see Fig. 5P) comprising an inflatable balloon (balloon 510; see Fig. 5P) having a plurality of cutting features disposed along the outer surface thereof (cutter blades 512; see Fig. 5P; see also Para. [0134]); wherein the cutting balloon catheter is configured to be inserted within a bodily cavity for the purposes of cutting and removing material therefrom (e.g., lesions, polyps, enlarged or abnormal tissue, etc.) (see Para. [0024], [0121]-[0122] and [0134]); wherein the inflatable balloon may comprise a variety of different shapes (see Figs. 5A-5N; see also Para. [0130] and [0134] mentioning wherein “the balloons in this invention” may comprise a variety of surface features, such as cutter blades thereon to make cuts in the desired tissue) including a balloon that, when inflated, tapers from maximum distance measured relative to a centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade (see Fig. 5K).
Since Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), 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 cutting balloon shape for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the balloon of Krolik such that, when inflated, the outer surface of the balloon is a varying distance relative to the centerline of the balloon such that the outer surface is at a maximum distance from the centerline at the distal end thereof and a minimum distance from the centerline at the proximal end thereof. As Krolik discloses wherein the shape of the cutting balloon can be varied without impacting the functionality of the device (see Krolik Para. [0028]), combined with the disclosure of Chang in which any of “the balloons in this invention” may comprise cutting features thereon to cut and remove undesired material from a tubular bodily cavity (see Chang Fig. 5P; see also Para. [0130] and [0134]) without impacting the functionality of the device, one of ordinary skill in the art would have expected the device of Krolik to function appropriately with a balloon having an outer surface shape that, when inflated, varies along the longitudinal axis thereof as a known alternative cutting balloon shape as disclosed by Chang. In the resulting combination, the cutting features of Krolik, secured to the outer surface of the tapered balloon, would be at a maximum distance from the centerline at the larger diameter distal end of the balloon and a minimum distance from the centerline at the smaller diameter proximal end of the balloon.
Additionally, in the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Bucino teaches a balloon catheter (balloon assembly 200; see Figs. 2B(1)-2B(3)) for use within the vasculature (see Para. [0005]-[0006], [0037] and [0078]; balloon assembly 200 is configured for use within the vasculature) comprising a plurality of cutting elements (protrusions 212; see Fig. 2B(4); see also Para. [0094]) disposed along the outer surface of the balloon (see Figs. 2B(1)-2B(4)); wherein the cutting elements include a base portion (proximal portion of protrusions 212 that are along the same axis as the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below) and a blade portion extending outwardly from the base portion (distal protruding portions of protrusions 212 that extend radially-outward from the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below); wherein the balloon catheter further comprises a braid extending over and radially outward of at least part of the base portion (braided template 220; see Fig. 2B(4); see also Para. [0088] and [0094]) which may be applied to the outer surface of the balloon to provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Para. [0012]-[0015] and [0124]).
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 inflatable balloon of Krolik to comprise a braided template layer disposed along the outer surface thereof and covering all elements directly attached thereto, leaving gaps for the tips of the cutting features, as taught and suggested by Bucino to, in this case, provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Bucino Para. [0012]-[0015] and [0124]).
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Examiner’s Diagram of Fig. 2B(4)
Regarding claim 2, the combination of Krolik, Chang and Bucino disclose the invention of claim 1, Krolik further discloses wherein the cutting edge of the blade comprises a straight line (see Para. [0007] and [0030] mentioning wherein the cutting features extend axially along the balloon and substantially parallel to the longitudinal axis of the device).
Regarding claim 10, the combination of Krolik, Chang and Bucino disclose the invention of claim 1, Krolik, as modified by Chang, further discloses wherein when inflated, the outer surface of the inflatable balloon is a varying distance relative to the centerline of the balloon (see Chang Fig. 5K showing wherein the tapered balloon, as incorporated into the device of Krolik, comprises a shape having a varying distance relative to the centerline of the balloon).
Regarding claim 11, the combination of Krolik, Chang and Bucino disclose the invention of claim 10, Krolik, as modified by Chang, further discloses wherein the distance between the outer surface of the inflatable balloon and the longitudinal axis is at a maximum at a distal region of the inflatable balloon and is at a minimum distance at a proximal region of the inflatable balloon (see Chang Fig. 5K showing wherein the tapered balloon, as incorporated into the device of Krolik, has a shape such that the outer surface of the balloon at distal end is further from the longitudinal centerline and the outer surface of the balloon at the proximal end is closer to the longitudinal centerline).
Regarding claim 12, the combination of Krolik, Chang and Bucino disclose the invention of claim 11, Krolik, as modified by Chang, further discloses wherein the cutting edge of the blade has a constant height relative to the outer surface of the inflatable balloon (see Krolik Para. [0029] mentioning wherein the cutting features may have either a uniform height or variable height along the lengths thereof).
Regarding claim 13, the combination of Krolik, Chang and Bucino disclose the invention of claim 11, Krolik, as modified by Chang, further discloses wherein the cutting edge of the blade has a varying height relative to the outer surface of the inflatable balloon (see Krolik Para. [0029] mentioning wherein the cutting features may have either a uniform height or variable height along the lengths thereof).
Regarding claim 14, the combination of Krolik, Chang and Bucino disclose the invention of claim 1, Krolik, as modified by Chang, further discloses one or more additional blades (see Krolik Figs 1-2 showing a plurality of cutting features disposed along the outer surface of the balloon; see also Krolik Para. [0029]), each of the one or more additional blades extending over and secured to the outer surface (see Krolik Fig. 1), each of the one or more additional blades having a cutting edge extending from a distal end of the blade to a proximal end of the blade (see Krolik Fig. 1; see also Krolik and Para. [0029]), the cutting edge extending when the inflatable balloon is inflated from a maximum distance measured relative to a centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade (cutting features of Krolik are attached to the balloon, as modified by the teachings of Chang, that comprises a shape having an enlarged diameter at the distal end and a smaller diameter at the proximal end (see Chang Fig. 5k) such that the height of each cutting feature would thereby taper from a maximum height from the centerline of the balloon at the larger-diameter distal end thereof to a minimum height from the centerline of the balloon at the smaller-diameter proximal end thereof).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Chang (US 2019/0314620 A1) (previously of record), further in view of Bucino (US 2013/0116655 A1), as applied to claim 1, further in view of Madej (US 2021/0153891 A1) (previously of record).
Regarding claim 4, the combination of Krolik, Chang and Bucino disclose all of the limitations of the invention of claim 1.
However, none of the combination expressly discloses wherein the braid is disposed within a polymeric layer that extends over and radially outward of at least part of the base portion of the blade.
In the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Madej teaches a balloon catheter (catheter 10; see Fig. 2) for use within the vasculature (see Para. [0042]) comprising a plurality of cutting elements (cutting members 20; see Figs. 2-5) disposed along the outer surface of the balloon (see Figs. 2-5); wherein the cutting elements include a base portion (base portion 36; see Fig. 4) and a blade portion extending outwardly from the base portion (cutting edge 38; see Fig. 4); wherein the balloon catheter further comprises a polymeric layer that extends over and radially outward of the entirety of the balloon catheter and cutting elements (covering 146; see Fig. 5; see also Para. [0069]-[0070]) to substantially prevent the cutting members from delaminating from the balloon (see Para. [0069]).
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 balloon of Krolik, as modified by Bucino, to comprise a polymeric layer substantially covering the entire surface of the balloon, cutting features and braided template as taught and suggested by Madej to, in this case, substantially prevent the cutting members from delaminating from the balloon (see Madej Para. [0069]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Erpen (US 2017/0056048 A1)(previously of record), further in view of Bucino (US 2013/0116655 A1), as applied to claim 1, further in view of Madej (US 2021/0153891 A1) (previously of record).
Regarding claim 4, the combination of Krolik, Erpen and Bucino disclose all of the limitations of the invention of claim 1.
However, none of the combination expressly discloses wherein the braid is disposed within a polymeric layer that extends over and radially outward of at least part of the base portion of the blade.
In the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Madej teaches a balloon catheter (catheter 10; see Fig. 2) for use within the vasculature (see Para. [0042]) comprising a plurality of cutting elements (cutting members 20; see Figs. 2-5) disposed along the outer surface of the balloon (see Figs. 2-5); wherein the cutting elements include a base portion (base portion 36; see Fig. 4) and a blade portion extending outwardly from the base portion (cutting edge 38; see Fig. 4); wherein the balloon catheter further comprises a polymeric layer that extends over and radially outward of the entirety of the balloon catheter and cutting elements (covering 146; see Fig. 5; see also Para. [0069]-[0070]) to substantially prevent the cutting members from delaminating from the balloon (see Para. [0069]).
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 balloon of Krolik, as modified by Bucino, to comprise a polymeric layer substantially covering the entire surface of the balloon, cutting features and braided template as taught and suggested by Madej to, in this case, substantially prevent the cutting members from delaminating from the balloon (see Madej Para. [0069]).
Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Erpen (US 2017/0056048 A1)(previously of record), further in view of Bucino (US 2013/0116655 A1) as applied to claim 1, further in view of Nakamura (US 2024/0108867 A1)(previously of record).
Regarding claim 5, the combination of Krolik, Erpen and Bucino disclose all of the limitations of the invention of claim 1.
However, while Krolik discloses wherein the balloon may comprise a variety of sizes and/or shapes (see Para. [0028]), Krolik does not expressly disclose wherein, when inflated, the outer surface of the inflatable balloon is a constant distance from the centerline of the balloon.
In the same field of endeavor, namely cutting balloon catheters for use within the vasculature to break apart legions or other occlusions, Nakamura teaches a balloon catheter (balloon catheter 10; see Fig. 1) having a plurality of tapered cutting elements (linear protrusions 30; see Fig. 2; see also Para. [0051]) disposed an outer surface of the expandable balloon (see Fig. 2; see also Para. [0051]); wherein the surface of the balloon upon which the cutting elements are disposed is a “straight tube portion” (see Fig. 2; see also Para. [0007] and [0051]).
Since Krolik discloses wherein the balloon may comprise a variety of sizes and/or shapes (see Para. [0028]), 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 cutting balloon shape for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the cutting surface of the balloon of Krolik be a constant distance from the centerline of the balloon (i.e., formed as a “straight tube portion”), when inflated, as disclosed as a known alternative cutting balloon shape by Nakamura. Since Krolik does not disclose any criticality to the shape of the balloon, indicating that a variety of shapes/sizes are possible (see Para. [0028]), one of ordinary skill in the art would have expected the device of Krolik, as modified by Erpen, to function appropriately should the surface of the balloon, when inflated, be a constant distance from the centerline of the balloon as disclosed as a known alternative balloon shape by Nakamura.
Regarding claim 6, the combination of Krolik, Erpen, Bucino and Nakamura disclose the invention of claim 5, Krolik, as modified by Erpen, further discloses wherein the cutting edge of the blade tapers from the distal end of the blade to the proximal end of the blade (see Erpen Figs. 1 and 4 showing wherein the tapered blade shape, as incorporated into the device of Krolik, tapers from a maximum blade height at the distal end of the blade to a minimum blade height at the proximal end of the blade; see also Erpen Para. [0030] and [0032] mentioning wherein this tapered shape is responsible for providing the benefit of gradually digging into the inner wall of the target area like a plough such that an abrupt mechanical effect is thus avoided so that a less painful treatment is possible).
Regarding claim 7, the combination of Krolik, Erpen, Bucino and Nakamura disclose the invention of claim 6, Krolik, as modified by Erpen, further discloses wherein the cutting edge of the blade defines a blade height above the outer surface of the inflatable balloon (see Erpen Figs. 1 and 4), and the blade height tapers from a maximum blade height at the distal end of the blade to a minimum blade height at the proximal end of the blade (see Erpen Figs. 1 and 4 showing wherein the tapered blade shape, as incorporated into the device of Krolik, tapers from a maximum blade height at the distal end of the blade to a minimum blade height at the proximal end of the blade; see also Erpen Para. [0030] and [0032] mentioning wherein this tapered shape is responsible for providing the benefit of gradually digging into the inner wall of the target area like a plough such that an abrupt mechanical effect is thus avoided so that a less painful treatment is possible).
Regarding claim 8, the combination of Krolik, Erpen, Bucino and Nakamura disclose all of the limitations of the invention of claim 7.
However, the combination, as presently combined, does not expressly disclose wherein the maximum blade height is in a range of 1 to 2 millimeters.
Erpen provides a further teaching of wherein the tapered cutting features (cutting elements 3; see Figs. 1 and 4) of the cutting balloon catheter (see Figs. 1 and 4) may have a maximum height within a range of 0.5 to 1.5mm (see Para. [0030]).
Since Krolik expressly mentions wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the tapered cutting features of Krolik, as previously modified by Erpen, to have a maximum blade height within the range of 1 to 2 millimeters, as further disclosed by Erpen, as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0017], [0028] and [0037] indicating wherein the maximum blade height “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 9, the combination of Krolik, Erpen, Bucino and Nakamura disclose all of the limitations of the invention of claim 8.
However, while the tapered blades of Erpen, as incorporated into the device of Krolik, appear to taper proximally so as to become flush with the balloon surface at the proximal end thereof (see Erpen Fig. 4), and while Krolik discloses wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), none of the combination expressly discloses wherein the minimum blade height is in a range of 0 to 0.5 millimeters.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the tapered cutting features of Krolik, as modified by Erpen, to have a minimum blade height of between 0mm and 0.5mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Krolik et al. would not operate differently with the claimed minimum blade height since Krolik expressly discloses wherein the cutting feature may have “any variable shape” (see Krolik Para. [0029]) without impacting the functionality of the device. Since the cutting features of Krolik have been modified be Erpen to comprise a tapered shape having a maximum height at the distal end and a minimum height at the proximal end thereof, the cutting features are seen to be fully functional should the minimum blade height be within a range of between 0 to 0.5mm. Further, applicant places no criticality on the range claimed, indicating simply that the minimum blade height “may” be within the claimed ranges (see Specification Para. [0018], [0029], [0037], [0080] and [0098]).
Claim(s) 10-11 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Erpen (US 2017/0056048 A1)(previously of record), further in view of Bucino (US 2013/0116655 A1), as applied to claim 1, further in view of Chang (US 2019/0314620 A1) (previously of record).
Regarding claim 10, the combination of Krolik, Erpen and Bucino disclose all of the limitations of the invention of claim 1.
However, while Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), Krolik does not expressly disclose wherein, when inflated, the outer surface of the inflatable balloon is a varying distance relative to the centerline of the balloon.
In the same field of endeavor, namely cutting balloon catheters configured to be inserted within a bodily space to cut and remove debris (e.g., lesions, polyps, enlarged or abnormal tissue, etc.) therefrom, Chang teaches a cutting balloon catheter (see Fig. 5P) comprising an inflatable balloon (balloon 510; see Fig. 5P) having a plurality of cutting features disposed along the outer surface thereof (cutter blades 512; see Fig. 5P; see also Para. [0134]); wherein the cutting balloon catheter is configured to be inserted within a bodily cavity for the purposes of cutting and removing material therefrom (e.g., lesions, polyps, enlarged or abnormal tissue, etc.) (see Para. [0024], [0121]-[0122] and [0134]); wherein the inflatable balloon may comprise a variety of different shapes (see Figs. 5A-5N; see also Para. [0130] and [0134] mentioning wherein “the balloons in this invention” may comprise a variety of surface features, such as cutter blades thereon to make cuts in the desired tissue) including a balloon that, when inflated, comprises an outer surface that varies in radial height along the longitudinal centerline thereof (see Fig. 5K).
Since Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), 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 cutting balloon shape for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the balloon of Krolik such that, when inflated, the outer surface of the balloon is a varying distance relative to the centerline of the balloon. As Krolik discloses wherein the shape of the cutting balloon can be varied without impacting the functionality of the device (see Krolik Para. [0028]), combined with the disclosure of Chang in which any of “the balloons in this invention” may comprise cutting features thereon to cut and remove undesired material from a tubular bodily cavity (see Chang Fig. 5P; see also Para. [0130] and [0134]) without impacting the functionality of the device, one of ordinary skill in the art would have expected the device of Krolik to function appropriately with a balloon having an outer surface shape that, when inflated, varies along the longitudinal axis thereof as a known alternative cutting balloon shape as disclosed by Chang.
Regarding claim 11, the combination of Krolik, Erpen, Bucino and Chang disclose the invention of claim 10, Krolik, as modified by Chang, further discloses wherein the distance between the outer surface of the inflatable balloon and the longitudinal axis is at a maximum at a distal region of the inflatable balloon and is at a minimum at a proximal region of the inflatable balloon (see Chang Fig. 5K showing wherein the tapered balloon, as incorporated into the device of Krolik, comprises a shape in which the outer surface thereof is at a maximum distance from the longitudinal axis at the distal thereof, and a minimum distance from the longitudinal axis at the proximal end thereof).
Regarding claim 13, the combination of Krolik, Erpen, Bucino and Chang disclose the invention of claim 11, Krolik, as modified by Erpen and Chang, further discloses wherein the cutting edge of the blade has a varying height relative to the outer surface of the inflatable balloon (the tapered blade of Krolik, as modified from the disclosure of Erpen, has a varied height relative to the outer surface of the tapered balloon of Krolik, as modified by the disclosure of Chang).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Bucino (US 2013/0116655 A1), further in view of Madej (US 2021/0153891 A1) (previously of record).
Regarding claim 15, Krolik discloses:
A medical device (apparatus 10; see Fig. 1), comprising:
a catheter shaft (catheter 20; see Fig. 1) including a distal region (portion of the catheter 20 upon which balloon 30 is disposed; see Fig. 1);
an inflatable balloon (balloon 30; see Fig. 1) secured to the distal region of the catheter shaft (see Fig. 1), the inflatable balloon including:
a blade, including a base portion (proximal portion(s) of cutting features 40 in direct abutment with the outer surface of the balloon 30; see Figs. 2-3) secured to the inflatable balloon surface (cutting features 40; see Figs. 1-3; see also Para. [0029]; see also Para. [0012] mentioning wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components).
However, while Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), in addition to wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), and wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components (see Para. [0012]), Krolik does not expressly disclose:
wherein the balloon comprises a constant diameter middle section corresponding to where a polymeric pad is secured to the outer surface of the inflatable balloon, a distal region that tapers to a distal waist and a proximal region that tapers to a proximal waist;
wherein the polymeric pad secured to the constant diameter middle section of the inflatable balloon;
wherein the blade is secured within the polymeric pad; and
a braid extending over the outer surface, the braid extending over and radially outward of at least part of the polymeric pad and/or at least part of the base portion.
In the same field of endeavor, namely cutting balloon catheters for use in cutting and removing targeting lesions from the vasculature, Madej teaches a cutting balloon catheter (cutting balloon 10; see Fig. 1) comprising a balloon (balloon 16; see Fig. 1) having a constant diameter middle section (see Fig. 2 showing wherein the middle portion of the balloon, to which cutting members 20 are disposed, is a constant diameter) corresponding to where a polymeric pad (mounting pad 40; see Fig. 2; see also Para [0063] mentioning wherein the mounting pads are formed from thermoplastic polyurethane) is secured to the outer surface of the inflatable balloon (see Fig. 2); the balloon further comprising a distal region that tapers to a distal waist (see Fig. 2) and a proximal region that tapers to a proximal waist (see Fig. 2); wherein a cutting blade (cutting members 20; see Fig. 2) is secured to the balloon surface within the polymeric pad (see Fig. 2; see also Para. [0052] mentioning wherein the cutting members are mounted “in” the mounting pad).
Since Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), 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 vascular cutting balloon shape for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the balloon of Krolik be formed such that the balloon has a constant-diameter middle section, along which the cutting features are disposed, in addition to having tapered proximal and distal portions on opposing terminal ends thereof as disclosed as an alternative balloon shape for vasculature-focused cutting balloons by Madej. As Krolik does not disclose any criticality to the balloon shape, mentioning wherein the balloon may take a variety of different shape (see Para. [0028]) while maintaining overall functionality, one of ordinary skill in the art would have expected the device of Krolik to function appropriately should the balloon be formed having a constant diameter middle portion and tapering terminal proximal and distal ends, especially since both balloons share an intended-use area and are both configured to perform a similar function in cutting and removing lesions or debris from within the vasculature.
Additionally, since Krolik discloses wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components (see Para. [0012]), it would have also 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 cutting feature securement mechanism for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the cutting features of Krolik be secured to the middle portion of the cutting balloon surface via a polymeric pad, as disclosed as an known alternative means of securing cutting features to the surface of a cutting balloon by Madej. Since Krolik expressly discloses wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components (see Para. [0012]), one of ordinary skill in the art would have expected the device of Krolik to function equally well should the cutting feature be either integrally formed with the outer surface of the balloon, or secured thereto within polymeric mounting pads, as disclosed by Madej, since Krolik discloses wherein the two mechanisms are interchangeable without impacting the functionality of the device.
Additionally, in the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Bucino teaches a balloon catheter (balloon assembly 200; see Figs. 2B(1)-2B(3)) for use within the vasculature (see Para. [0005]-[0006], [0037] and [0078]; balloon assembly 200 is configured for use within the vasculature) comprising a plurality of cutting elements (protrusions 212; see Fig. 2B(4); see also Para. [0094]) disposed along the outer surface of the balloon (see Figs. 2B(1)-2B(4)); wherein the cutting elements include a base portion (proximal portion of protrusions 212 that are along the same axis as the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below) and a blade portion extending outwardly from the base portion (distal protruding portions of protrusions 212 that extend radially-outward from the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below); wherein the balloon catheter further comprises a braid extending over and radially outward of at least part of the base portion (braided template 220; see Fig. 2B(4); see also Para. [0088] and [0094] which may be applied to the outer surface of the balloon to provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Para. [0012]-[0015] and [0124]).
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 inflatable balloon of Krolik to comprise a braided template layer disposed along the outer surface thereof and covering all elements directly attached thereto, leaving gaps for the tips of the cutting features, as taught and suggested by Bucino to, in this case, provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Bucino Para. [0012]-[0015] and [0124]).
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Examiner’s Diagram of Fig. 2B(4)
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Bucino (US 2013/0116655 A1), further in view of Madej (US 2021/0153891 A1) (previously of record), as applied to claim 15, further in view of St. Martin (US 2007/0016232 A1) (previously of record).
Regarding claim 16, the combination of Krolik, Bucino and Madej disclose all of the limitations of the invention of claim 15.
However, none of the combination expressly disclose a maximum diameter for the balloon, when inflated, and thus do not expressly disclose wherein the constant diameter middle section has a diameter when inflated in a range of 1.5 to 2.5 millimeters.
In the same field of endeavor, namely cutting balloon catheters for use within the vasculature, St. Martin teaches a cutting balloon catheter (balloon catheter 20; see Fig. 1) comprising a balloon (balloon 24; see Fig. 1) having a constant diameter middle section (see Figs. 1 and 3B) and two tapered portions on the terminal ends thereof (see Figs. 1 and 3B); wherein the constant diameter middle section may be inflated to “at least two millimeters” (see Para. [0029]).
Since Krolik expressly discloses wherein the balloon may comprise a variety of sizes and/or shapes (see Para. [0028]), 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 balloon of Krolik, as modified by Madej, to comprise a maximum inflation diameter of two millimeters as disclosed by St. Martin. Since the devices of both Krolik and St. Martin are configured for use within the vasculature (see also St. Martin Para. [0032]-[0033]), the dimensions of the balloon of St. Martin are understood to be applicable to the device Krolik and provide a known value in light of the absence of a disclosed inflation size within the disclosure of Krolik. Further, applicant appears to have placed no criticality on the claimed range (see Specification Para. [0017], [0036], [0079], [0093] and [0096] indicating the diameter “may” be within the claimed range) and it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Bucino (US 2013/0116655 A1), further in view of Madej (US 2021/0153891 A1) (previously of record), as applied to claim 15, further in view of Erpen (US 2017/0056048 A1)(previously of record).
Regarding claim 17, the combination of Krolik, Bucino and Madej disclose the invention of claim 15.
However, while Krolik discloses wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), Krolik does not expressly disclose:
wherein the blade defines a tapered cutting edge extending from a distal end of the blade to a proximal end of the blade, the tapered cutting edge having a maximum blade height relative to the polymeric pad at the distal end of the blade and a minimum blade height relative to the polymeric pad at the proximal end of the blade;
the minimum blade height is in a range of 0 to 0.5 millimeters; and
the maximum blade height is in a range of 1 to 2 millimeters.
In the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Erpen teaches a balloon catheter (see Fig. 1) for use within the vasculature (see Para. [0005] and [0018]) comprising a plurality of cutting elements (cutting elements 3; see Figs. 1 and 4) disposed along the outer surface of the balloon (see Figs. 1 and 4), wherein the cutting elements comprise a height that tapers from a maximum distance measured relative to a centerline of the balloon at the distal end of the blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade (see Figs. 1 and 4; see also Para. [0030]) to enable the cutting elements to gradually dig into the inner wall of the vessel to produce a less painful treatment (see Para. [0032] mentioning wherein the axially variably shape of the cutting elements is responsible for “gradually digging into the inner wall of the vein like a plough such that an abrupt mechanical effect is thus avoided so that a less painful treatment is possible which, in some circumstances, can even be carried out without local anesthetic in the form of a tumescent anesthetic”).
Since Krolik provides express disclosure of wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), 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 shape of the cutting features of Krolik to comprise a tapered profile in which the height of the cutting features decreases from a maximum distance measured relative to a centerline of the balloon at the distal end of the cutting feature to a minimum distance measured relative to the centerline of the balloon at the proximal end of the cutting feature as taught and suggested by Erpen to, in this case, provide a known alternative variable-height cutting feature/element shape that enables the cutting features/elements to gradually dig into the target occlusion within the vasculature while providing a less painful treatment (see Erpen Para. [0032]).
However, while the tapered blades of Erpen, as incorporated into the device of Krolik, appear to taper proximally so as to become flush with the balloon surface at the proximal end thereof (see Erpen Fig. 4), the combination, as presently combined, does not expressly disclose wherein the maximum blade height is in a range of 1 to 2 millimeters and wherein the minimum blade height is in a range of 0 to 0.5 millimeters.
Erpen provides a further teaching of wherein the tapered cutting features (cutting elements 3, see Figs. 1 and 4) of the cutting balloon catheter (see Figs. 1 and 4) may have a maximum height within a range of 0.5 to 1.5mm (see Para. [0030]).
Since Krolik expressly mentions wherein the cutting features “may have variable height along the pointed edge between the ends of the cutting feature to enhance penetration into tissue” (see Para. [0029]), it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have further modified the cutting features of Krolik, as previously modified by Erpen, to have a maximum blade height within the range of 1 to 2 millimeters, as further disclosed by Erpen, as applicant appears to have placed no criticality on the claimed range (see Specification Para. [0017], [0028] and [0037] indicating wherein the maximum blade height “may” be within the claimed range) and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It would additionally have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the tapered cutting features of Krolik, as modified by Erpen, to have a minimum blade height of between 0mm and 0.5mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Krolik et al. would not operate differently with the claimed minimum blade height and since Krolik expressly discloses wherein the cutting feature may have “any variable shape” (see Krolik Para. [0029]) without impacting the functionality of the device. Since the cutting features of Krolik have been modified be Erpen to comprise a tapered shape having a maximum height at the distal end and a minimum height at the proximal end thereof, the cutting features are seen to be fully functional should the minimum blade height be within a range of between 0 to 0.5mm. Further, applicant places no criticality on the range claimed, indicating simply that the minimum blade height “may” be within the claimed ranges (see Specification Para. [0018], [0029], [0037], [0080] and [0098]).
Claim(s) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) (previously of record) in view of Madej (US 2021/0153891 A1) (previously of record), further in view of Chang (US 2019/0314620 A1) (previously of record), further in view of Bucino (US 2013/0116655 A1).
Regarding claim 18 (see 112(b) rejection above), Krolik discloses:
A medical device (apparatus 10; see Fig. 1), comprising:
a catheter shaft (catheter 20; see Fig. 1) including a distal region (portion of the catheter 20 upon which balloon 30 is disposed; see Fig. 1);
an inflatable balloon (balloon 30; see Fig. 1) secured to the distal region of the catheter shaft (see Fig. 1); and
a blade including a base portion (proximal portion(s) of cutting features 40 in direct abutment with the outer surface of the balloon 30; see Figs. 2-3) secured to the outer surface of the inflatable balloon (cutting features 40; see Figs. 1-3; see also Para. [0029]; see also Para. [0012] mentioning wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components), the blade defining a cutting edge extending from a distal end of the blade to a proximal end of the blade (see Figs. 1-3; see also Para. [0029]-[0031]).
However, while Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), in addition to wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components (see Para. [0012]), Krolik does not expressly disclose:
wherein the inflatable balloon includes a tapered middle section corresponding to where a polymeric pad is secured to an outer surface of the inflatable balloon, the tapered middle section tapering from a maximum diameter near a distal region to a minimum diameter near a proximal region;
wherein the polymeric pad secured to the tapered middle section of the inflatable balloon;
wherein the blade is secured within the polymeric pad; and
a braid extending over the outer surface, the braid extending over and radially outward of at least part of the base portion.
In the same field of endeavor, namely cutting balloon catheters configured to be inserted within a bodily space to cut and remove debris (e.g., lesions, polyps, enlarged or abnormal tissue, etc.) therefrom, Chang teaches a cutting balloon catheter (see Fig. 5P) comprising an inflatable balloon (balloon 510; see Fig. 5P) having a plurality of cutting features disposed along the outer surface thereof (cutter blades 512; see Fig. 5P; see also Para. [0134]); wherein the cutting balloon catheter is configured to be inserted within a bodily cavity for the purposes of cutting and removing material therefrom (e.g., lesions, polyps, enlarged or abnormal tissue, etc.) (see Para. [0024], [0121]-[0122] and [0134]); wherein the inflatable balloon may comprise a variety of different shapes (see Figs. 5A-5N; see also Para. [0130] and [0134] mentioning wherein “the balloons in this invention” may comprise a variety of surface features, such as cutter blades thereon to make cuts in the desired tissue) including a balloon that, when inflated, comprises an outer surface that tapers in radial diameter along the longitudinal axis thereof from a maximum diameter at the distal region of the balloon to a minimum diameter at the proximal region of the balloon (see Fig. 5K).
Since Krolik expressly discloses the balloon may be expanded to variety of sizes and/or shapes (see Para. [0028]), 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 cutting balloon shape for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of forming the balloon of Krolik such that, when inflated, the outer surface of the balloon is tapered along the length therefrom from a maximum diameter at the distal end to a minimum diameter at the proximal end thereof. As Krolik discloses wherein the shape of the cutting balloon can be varied without impacting the functionality of the device (see Krolik Para. [0028]), combined with the disclosure of Chang in which any of “the balloons in this invention” may comprise cutting features thereon to cut and remove undesired material from a tubular bodily cavity (see Chang Fig. 5P; see also Chang Para. [0130] and [0134]) without impacting the functionality of the device, one of ordinary skill in the art would have expected the device of Krolik to function appropriately with a balloon having an outer surface shape that, when inflated, tapers varies along the longitudinal axis thereof as a known alternative cutting balloon shape as disclosed by Chang.
In the same field of endeavor, namely cutting balloon catheters for use in cutting and removing targeting lesions from the vasculature, Madej teaches a cutting balloon catheter (cutting balloon 10; see Fig. 1) comprising a balloon (balloon 16; see Fig. 1) having a middle section (see Fig. 2) corresponding to where a polymeric pad (mounting pad 40; see Fig. 2; see also Para [0063] mentioning wherein the mounting pads are formed from thermoplastic polyurethane) is secured to the outer surface of the inflatable balloon (see Fig. 2); wherein a cutting blade (cutting members 20; see Fig. 2) is secured to the balloon surface within the polymeric pad (see Fig. 2; see also Para. [0052]).
Since Krolik discloses wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components (see Para. [0012]), it would have also 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 cutting feature securement mechanism for another (see KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)) to have obtained the predictable result of having the cutting features of Krolik be secured to the middle portion of the cutting balloon surface via a polymeric pad, as disclosed as an known alternative means of securing cutting features to the surface of a cutting balloon by Madej. Since Krolik expressly discloses wherein the raised structures (i.e., cutting features 40) may be either integrally molded with the outer surface of the balloon or attached thereto as separate components (see Para. [0012]), one of ordinary skill in the art would have had expected the device of Krolik to function equally well should the cutting feature be either integrally formed with the outer surface of the balloon, or secured thereto within polymeric mounting pads, as disclosed by Madej, since Krolik discloses wherein the two mechanisms are interchangeable without impacting the functionality of the device.
Additionally, in the same field of endeavor, namely cutting balloon catheters for use in the vasculature, Bucino teaches a balloon catheter (balloon assembly 200; see Figs. 2B(1)-2B(3)) for use within the vasculature (see Para. [0005]-[0006], [0037] and [0078]; balloon assembly 200 is configured for use within the vasculature) comprising a plurality of cutting elements (protrusions 212; see Fig. 2B(4); see also Para. [0094]) disposed along the outer surface of the balloon (see Figs. 2B(1)-2B(4)); wherein the cutting elements include a base portion (proximal portion of protrusions 212 that are along the same axis as the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below) and a blade portion extending outwardly from the base portion (distal protruding portions of protrusions 212 that extend radially-outward from the flat outer surface of the balloon; see Examiner’s Diagram of Fig. 2B(4) below); wherein the balloon catheter further comprises a braid extending over and radially outward of at least part of the base portion (braided template 220; see Fig. 2B(4); see also Para. [0088] and [0094] which may be applied to the outer surface of the balloon to provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Para. [0012]-[0015] and [0124]).
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 inflatable balloon of Krolik to comprise a braided template layer disposed along the outer surface thereof and covering all elements directly attached thereto, leaving gaps for the tips of the cutting features, as taught and suggested by Bucino to, in this case, provide additional strength/reinforcement, promote tissue ingrowth and/or deliver therapeutic agents (see Bucino Para. [0012]-[0015] and [0124]).
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Examiner’s Diagram of Fig. 2B(4)
Regarding claim 19, the combination of Krolik, Madej, Bucino and Chang disclose the limitations of the invention of claim 18, Krolik, as modified by Madej, further discloses wherein the cutting edge has a uniform height measured relative to the polymeric pad (see Krolik Para. [0029] mentioning wherein the cutting features may have either a uniform height or variable height along the lengths thereof).
Regarding claim 20, the combination of Krolik, Madej, Bucino and Chang disclose the limitations of the invention of claim 18, Krolik, as modified by Madej, further discloses wherein the cutting edge has a varying height measured relative to the polymeric pad (see Krolik Para. [0029] mentioning wherein the cutting features may have either a uniform height or variable height along the lengths thereof).
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 2011/0213403 A1 to Aboytes, US 20230363786 A1 to Anderson, US 20040260333 A1 to Debrul, US 20200114130 A1 to Davies, US 20020010489 A1 to Grayzel, US 20040034384 A1 to Fukaya, US 5713913 A to Lary and US 9327102 B2 to Aggerholm all disclose cutting balloon catheters having either a braided top layer and/or a polymeric top layer coving at least a portion of a base portion of a cutting element.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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