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, see “Remarks”, filed 1/16/2026, with respect to the rejection(s) of claim(s) 1 under Nakamura (US 2024/0108867 A1), in view of Erpen (US 2017/0056048 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Krolik (US 2010/0286593 A1).
Specifically, Applicant correctly points out that Nakamura discloses inherent criticality pertaining to the tapered cutting members in providing for increased insertability into a lesion site due to the tapered profile (see Nakamura Para. [0012], [0070] and [0077]). The Examiner agrees that this benefit is only achieved and possible by arranging the tapered blades of Nakamura such that they taper from a maximum distance from the balloon surface at the proximal end to a minimum distance from the balloon surface at the distal end. This is the opposite of the claimed invention’s tapered blade arrangement. Due to this criticality and disclosed benefit, the Examiner agrees that it would not have been obvious to one of ordinary skill in the art to have modified the tapered blades of Nakamura to be arranged in the claimed manner as doing so would destroy the functional benefit the current arrangement provides. The rejection of claim 1 under Nakamura has been overcome. However, a new rejection of claim 1 is provided below in view of Krolik (US 2010/0286593 A1) and a new non-final rejection is furnished herein.
Applicant’s arguments with respect to claim(s) 1 under St. Martin (US 2007/0016232 A1) in view of Chang (US 2019/0314620 A1) have been considered but are moot because the new ground of rejection does not rely on St. Martin as the primary reference in the new rejection furnished below.
However, as several of Applicant’s arguments pertain to a more broad interpretation of the prior art, relevant arguments will be addressed below as they pertain to the updated rejection furnished herein.
Regarding claim 1, Applicant contends that the claim language of “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” does not merely require a tapered balloon, but a blade configuration where the cutting edge itself has a specific geometric relationship to the balloon centerline that varies from distal to proximal (see Pg. 10/18 of submitted arguments). The Examiner respectfully disagrees. As the claim language only requires the blade be tapered relative to a “centerline of the balloon”, this taper does not necessarily need to come from a tapering of the blade itself, but may instead be met by having a blade disposed along the surface of a tapered balloon. For example, in Chang Fig. 5K (see annotated diagram below), should a blade be disposed along the outer surface of Chang, the portion of the blade at “Point A” located at the distal end of the tapered balloon in which the diameter of the balloon is greatest would be further away from the centerline than the portion of the blade located at “Point B”, located at the proximal end of the tapered balloon wherein the diameter is smallest. The resulting tapered balloon configuration, would have an ordinary straight blade be further away from the centerline of the balloon at the distal end, while being closest to the centerline of the balloon at the proximal end. As the claim language recites the “balloon centerline” as the reference point, rather than the surface of the balloon, this interpretation is seen to read on the current claim language.
PNG
media_image1.png
200
776
media_image1.png
Greyscale
Chang Fig. 5K
Applicant contends that one of ordinary skill in the art would not have combined the devices of St. Martin and Chang on the grounds that the two cutting balloon catheters are configured for use in entirely difference areas of the body. Specifically, Chang is configured for use within the paranasal sinuses and other structures in the ear, nose or throat, whereas St. Martin is configured for use within the vasculature. Due to the different fields, one of ordinary skill in the art would not have been motivated to combine the two references. The Examiner respectfully disagrees with the scope of the applied interpretation. While the devices of St. Martin and Chang may be specifically configured for use in different areas of the body, both are classified as cutting balloon catheters and overlap in scope in many aspects. Specifically, the generic components of a cutting balloon (e.g., delivery catheter, expandable balloon and cutting members) are shared amongst all cutting balloon catheters, regardless of intended use area and are thus seen to be analogous art in most instances. While different use areas may have target-specific aspects, such as size constraints in different parts of the body, the generic components of cutting balloon catheters are viewed to be analogous across a wide array of intended use areas. The Examiner therefore contends that it would have been obvious to one of ordinary skill in the art to have looked at alternative balloon shapes for cutting balloon catheters in different intended use areas and it would have thus been obvious to have modified the balloon shape of St. Martin to comprise one of the listed alternative shapes disclosed by Chang. As Chang does not appear to disclose wherein the alternative balloon shapes are sinus-specific (i.e., the balloon shapes do not appear to be shaped such that their use is only applicable within the sinus or throat), the balloon shapes are thus seen to be generic to cutting balloon catheters.
Applicant’s arguments pertaining the tapered cutting blades being beneficial in a method of pulling the blade proximally through a lesion with the inflatable balloon inflated (see Arguments, Pg. 13/18) are not seen to be persuasive in overcoming the prior art as the disclosed beneficial use/method steps are not currently recited in the claims. The Examiner notes that, as the claims are currently classified as “apparatus claims”, so long as the prior art is reasonably capable of performing any recited function language, that functional language is not patentable over the prior art.
Applicant's arguments filed 1/16/2026 with respect to the rejection of claim 15 over St. Martin (US 2007/0016232 A1) (previously of record) in view of Erpen (US 2017/0056048 A1)(previously of record) have been fully considered but they are not persuasive.
As St. Martin is no longer relied upon to disclose limitations specifically challenged in Applicant’s arguments, arguments pertaining to St. Martin’s teaching of limitations of claim 15 are considered moot.
However, as Erpen remains relied upon to disclose limitations challenged in the submitted arguments, pertaining to Erpen will be addressed below.
Applicant contends that Erpen does not expressly or adequately disclose the limitations of “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” on the grounds that Erpen discloses the opposite configuration. Applicant cites to Para. [0030] of Erpen which recites that the blade runs at a height which decreases in the direction towards the distal end section 1b and the distal end 3b of the cutting element 3 is therefore located closer to the center of the axis A than the proximal end 3a. The examiner respectfully disagrees. As noted in the non-final office action, dated 10/16/2025, Erpen’s recitation of “proximal” and “distal” is opposite to conventional interpretations. As shown in Fig. 1 below, the disclosed “distal end section 1b” is located at the handle end of the device and comprises fluid connection “5” used to connect and transfer inflation media to the balloon located at the “proximal end section 1a”. Correspondingly, the “proximal end 1a” comprises the tip of the device which is configured to be inserted into the vasculature, leaving the connection means “5” outside the body to allow a user to transfer inflation media to the balloon (see Para. [0018]). The Examiner’s cited “reinterpretation” was intended to re-orient the device using conventional directional guidance in which the insertion end is considered the “distal end” wherein the handle is considered the “proximal end”. Noting this difference, the blade of Erpen does in fact taper from the insertion end towards the handle end, which would conventionally be interpreted to mean the blade tapers from a maximum height at the “distal end” end to a minimum height at the “proximal end” if rewritten to align with the claimed invention’s terminology.
PNG
media_image2.png
355
1005
media_image2.png
Greyscale
Erpen Fig. 1
Lastly, Applicant contends that St. Martin does not disclose or suggest any need for a tapered blade as claimed, whereas the claimed invention discloses numerous benefits provided by the tapered blade. It would thus not have been obvious to have incorporated the tapered blade of Erpen into the device of St. Martin due to this lack of disclosed “need” combined with the myriad of benefit provided thereby as disclosed in the claimed invention. The Examiner respectfully notes that, while the tapered blade of the claimed invention may have many functional benefits, limitations cannot be read into the claims impermissibly from the specification. Additionally, due to the classification of the claims as “apparatus claims”, the prior art need only be reasonable capable of performing any claimed functional language to read on the claims.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see “Remarks”, filed 1/16/2026, with respect to 35 USC 112(b) rejection of claim 15 for reciting “corresponding to where the polymeric pad is secured to the outer surface” followed by a recitation of “…a polymeric pad secured to the constant diameter middle section”, which resulted in a lack of antecedent basis for the initial recitation of “the polymeric pad” due a prior recitation to define said polymeric pad, have been fully considered and are persuasive in light of Applicant’s amendment to have the cited limitations recite, “corresponding to where a polymeric pad is secured to the outer surface” followed by a recitation of “…the polymeric pad secured to the constant diameter middle section” which establish proper antecedent basis for the polymeric pad limitations. The 35 USC 112(b) rejection of claims 15-17 have been withdrawn.
Applicant’s arguments, see “Remarks”, filed 1/16/2026, with respect to 35 USC 112(b) rejection of claim 18 for reciting “corresponding to where the polymeric pad is secured to the outer surface” followed by a recitation of “…a polymeric pad secured to the constant diameter middle section”, which resulted in a lack of antecedent basis for the initial recitation of “the polymeric pad” due a prior recitation to define said polymeric pad, have been fully considered and are persuasive in light of Applicant’s amendment to have the cited limitations recite, “corresponding to where a polymeric pad is secured to the outer surface” followed by a recitation of “…the polymeric pad secured to the constant diameter middle section” which establish proper antecedent basis for the polymeric pad limitations. The 35 USC 112(b) rejection of claims 18-20 have been withdrawn.
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) in view of Erpen (US 2017/0056048 A1)(previously of record).
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 upon which balloon 30 is disposed, see Fig. 1);
an inflatable balloon (balloon 30, see Fig. 1 and 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 and 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 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 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.
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 and 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 dig 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 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 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 blade to a minimum distance measured relative to the centerline of the balloon at the proximal end of the blade as taught and suggested by Erpen to, in this case, provide a known alternative variable-height blade shape that enables the cutting elements to gradually dig into the target occlusion within the vasculature while providing a less painful treatment (see Erpen Para. [0032]).
Regarding claim 2, the combination of Krolik and Erpen 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 and Erpen 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 and Erpen 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 disposed along the outer surface of the balloon; see also 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 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, 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) in view of Chang (US 2019/0314620 A1) (previously of record).
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 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 and 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 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.
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 and 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 and 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 and 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.
Regarding claim 2, the combination of Krolik and Chang 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 and Chang 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 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 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 and Chang 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 and Chang 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 and Chang 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 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 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) in view of Chang (US 2019/0314620 A1) (previously of record), as applied to claim 1, further in view of Jamous (US 2022/0287737 A1)(previously of record).
Regarding claim 4, the combination of Krolik and Chang disclose all of the limitations of the invention of claim 1.
However, none of either Krolik or Chang expressly discloses a braid extending through at least a portion of the elongate shaft and/or the inflatable balloon.
In the same field of endeavor, namely cutting balloon catheters, Jamous teaches wherein a braid layer may be disposed within the elongate catheter body of a cutting balloon catheter to provide increased rigidity and strength thereto (see Para. [0042]).
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 catheter shaft of Krolik to include a braided stainless steel layer therein as taught and suggested by Jamous to, in this case, provide increased rigidity and strength thereto (see Jamous Para. [0042]).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) in view of Erpen (US 2017/0056048 A1)(previously of record), as applied to claim 1, further in view of Jamous (US 2022/0287737 A1)(previously of record).
Regarding claim 4, the combination of Krolik and Erpen disclose all of the limitations of the invention of claim 1.
However, none of either Krolik or Erpen expressly discloses a braid extending through at least a portion of the elongate shaft and/or the inflatable balloon.
In the same field of endeavor, namely cutting balloon catheters, Jamous teaches wherein a braid layer may be disposed within the elongate catheter body of a cutting balloon catheter to provide increased rigidity and strength thereto (see Para. [0042]).
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 catheter shaft of Krolik to include a braided stainless steel layer therein as taught and suggested by Jamous to, in this case, provide increased rigidity and strength thereto (see Jamous Para. [0042]).
Claim(s) 5-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) in view of Erpen (US 2017/0056048 A1)(previously of record), as applied to claim 1, further in view of Nakamura (US 2024/0108867 A1)(previously of record).
Regarding claim 5, the combination of Krolik and Erpen 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 and Para. [0051]) disposed an outer surface of the expandable balloon (see Fig. 2 and Para. [0051]); wherein the surface of the balloon upon which the cutting elements are disposed is a “straight tube portion” (see Fig. 2 and 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 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 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 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 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 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.
However, 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 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) in view of Erpen (US 2017/0056048 A1)(previously of record), as applied to claim 1, further in view of Chang (US 2019/0314620 A1) (previously of record).
Regarding claim 10, the combination of Krolik and Erpen 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 and 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 and 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 and 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 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 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 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) in view of Erpen (US 2017/0056048 A1)(previously of record), further in view of Madej (US 2021/0153891 A1).
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 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 secured to the inflatable balloon surface (cutting features 40, see Figs. 1-3 and 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
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.
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 and 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 and 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.
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 the balloon surface at the distal end of the blade to a minimum distance measured relative to balloon surface at the proximal end of the blade (see Figs. 1 and 4 and 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 dig 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 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 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 tapers, relative to the balloon surface, from a maximum distance at the distal end of the blade to a minimum distance at the proximal end of the blade as taught and suggested by Erpen to, in this case, provide a known alternative blade shape that enables the cutting elements to gradually dig into the target occlusion within the vasculature while providing a less painful treatment (see Erpen Para. [0032]).
Regarding claim 17, the combination of Krolik, Erpen and Madej disclose the invention of claim 15.
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.
However, 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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) in view of Erpen (US 2017/0056048 A1)(previously of record), further in view of Madej (US 2021/0153891 A1), 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, Erpen 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) 18-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krolik (US 2010/0286593 A1) in view of Madej (US 2021/0153891 A1), further in view of Chang (US 2019/0314620 A1) (previously of record).
Regarding claim 18, 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 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 secured to the outer surface of the inflatable balloon (cutting features 40, see Figs. 1-3 and 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 and 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 the 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; and
wherein the blade is secured within the polymeric pad.
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 and 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 and 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 and 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 and 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 and 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.
Regarding claim 19, the combination of Krolik, Madej 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 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 20150202089 A1 to Campbell, US 2005/0149082 A1 to Yee, US 2005/0059965 A1 to Eberl and US 20110160645 A1 to Sutermeister all disclose cutting ballons having either various balloon shapes known in the art and/or polymeric pads upon which cutting elements are mounted.
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
Prosecution Insights