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 the prior art of Schaeffer in view of Zhu, Lee, and Giasolli, have been fully considered and are not found persuasive. Noting that Schaefer desires to treat the lesion only and not healthy tissue adjacent the lesion, applicant asserts that rotating the modified device of Schaeffer 30 to 75 degrees as required by the claims and then reinflating could easily place one of the blades (claimed “traction elements”) against healthy tissue, and thus it would not have been obvious to further modify the method of Schaeffer to rotate the balloon by 30 to 75 degrees as taught by Giasolli. This argument is not found persuasive. Schaefer discloses rotating the balloon prior to re-inflation to directly engage additional segments of the lesion ([0059]). Additionally, Schaefer discloses that the procedure may be viewed using an endoscope or other direct visualization techniques ([0073]) and thus the user is able to determine when the traction elements are aligned with the lesion. Whether or not a rotation of 45 degrees as taught by Giasolli would result in the traction elements engaging healthy tissue is entirely dependent on the circumferential extent of the lesion and the starting location of the traction elements relative to the lesion. Because the eccentric lesion may extend the majority of the circumference of the blood vessel, or just under 180 degrees in the case of claims 7 and 21-23, and Schaeffer discloses viewing the procedure using an endoscope or other direct visualization technique, one skilled in the art would have found it obvious to modify Schaeffer to rotate the device 45 degrees as taught by Giasolli whenever the lesion has a circumferential extent large enough to allow for such a rotation while still engaging lesion tissue with the traction elements for the predictable result of applying pressure to additional segments of the lesion to crack the lesion at multiple positions. Applicant also asserts that, because Giasolli discloses micro fissures forming at the location of the wedge dissectors (corresponding to claimed traction elements) as opposed to cracks between the wedge dissectors, one skilled in the art would not have looked to Giasolli to modify the method of Schaeffer. This is not found persuasive since both methods involve applying pressure to a lesion in order to cause cracks to form in the lesion, and one skilled in the art would have reasonably expected that rotation of the blades prior to forming the additional crack(s) results in a corresponding rotation of the location of the additional crack(s) whether the crack(s) occurs at a blade or between blades.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-3, 7, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schaeffer (US 2012/0316589) in view of Zhu et al. (Zhu X, Umezu M, Iwasaki K (2021) Finite element analysis of cutting balloon expansion in a calcified artery model of circular angle 180°: Effects of balloon-to-diameter ration and number of blades facing calcification on potential calcification fracturing and perforation reduction. Plos ONE 16(5): e0251404), Lee et al. (US 6,697,667) and Giasolli et al. (US 2018/0200491).
Regarding claim 1, Schaeffer discloses a method of treating a lesion within a blood vessel (see [0002], [0027], [0068], [0069]), the method comprising advancing a catheter through the vessel to a treatment site proximate the lesion (see fig. 6A, noting bodily passage may be a blood vessel), the catheter including a torqueable shaft (20; as understood in view of arrows in fig. 6C, rotation of shaft at exposed proximal end is transmitted to distal end; [0074]) extending from a hub (see enlarged end 27 that includes side port: figs. 6a-c) fixedly secured to a proximal end region of the shaft to an inflatable balloon (40) fixedly secured to a distal end region of the shaft, the catheter including a plurality of traction elements (50; see [0045], [0051]) disposed about the inflatable balloon, wherein the inflatable balloon is adapted to urge the plurality of traction elements outwardly when the inflatable balloon is inflated; thereafter inflating the inflatable balloon to urge one or more of the traction elements radially outwardly into contact with the lesion ([0059]), thereafter deflating the inflatable balloon ([0059]), thereafter rotating the hub of the catheter to achieve a corresponding rotation of the balloon of the catheter relative to the treatment site ([0059] and note arrows in fig. 6C: it would have been obvious to rotate the catheter and balloon via the hub as the hub is positioned external to the body as is known in the art and provides a handle), and thereafter, re-inflating the balloon to urge one or more of the plurality of traction elements radially outwardly into contact with the lesion ([0059]).
As understood in view of at least [0025] and [0082], which discloses “aligning the one or more raised elements with the portion of the bodily passage intended to be treated by the catheter”, and paragraph [0004], which discloses the desire to specifically direct the traction elements to the area of an eccentric lesion that needs to be cut while avoiding healthy tissue, it would have been obvious to concurrently engage the lesion with at least two of the traction elements during the step of inflating the inflatable balloon and/or during the step of re-inflating the inflatable balloon for the predictable result of concurrently providing multiple score/cut lines in the lesion while avoiding scoring/cutting adjacent healthy tissue. See also paragraph [0051], which includes that more rows of traction elements may be provided and each row may have a plurality of discrete traction elements as opposed to a single elongated traction element.
Schaeffer discloses that urging the at least two traction elements radially outwardly into contact with the lesion causes the lesion to crack (lesion is cut or scored as per [0028] and [0059], which is considered to read on “crack”), but Schaeffer does not expressly disclose that urging the at least two traction elements radially outward into contact with the lesion causes at least a portion of the lesion between the plurality of traction elements to crack.
Zhu discloses that the calcification expansion ability of a cutting balloon is higher when two blades face the calcification than when only one blade does (abstract). Zhu further discloses that such an arrangement lowers the stress on parts of the vessel wall circumferentially adjacent the eccentric calcification (i.e., the healthy tissue on either side of the eccentric calcification; see “Discussion”; page 10, 11). Zhu further discloses that the maximum principle tensile stress experienced by the lesion falls between the two blades as shown in fig. 7 (page 10), and maximum principle tensile stress is associated with plaque rupture (see “results” section on page 5). Thus, it would have been obvious to one ordinary skill in the art to have positioned two cutting blades of the balloon of Schaeffer such that they both face the calcification in a manner that the maximum principle tensile stress experienced by the lesion falls between the two blades, thus causing cracking of the lesion between the two blades, particularly in cases where the lesion is radially thinner at a location between the two blades, in view of the prior art of Zhu since such an arrangement increases the expansion ability of the cutting balloon while simultaneously lowering stress on parts of the vessel wall adjacent the calcification as compared to when a single blade faces the lesion.
Schaeffer in view of Zhu makes obvious the invention substantially as stated above including rotating the hub in order to achieve a corresponding rotation of the balloon of the catheter via a torqueable shaft extending between the hub and the proximal waist of the balloon (see figs. 6A-C and [0059]), but does not expressly disclose that the torqueable shaft includes a braid or coil extending from the hub to a proximal waist of a balloon, and that, for a given angle of rotation of the hub of the catheter, the balloon of the catheter rotates in the same direction an angle of rotation that is within 20 or 10 percent of the given angle of rotation.
Lee discloses another balloon catheter comprising a torqueable shaft (106) having a hub (112; fig. 2) fixedly secured to a proximal end region of the shaft and a balloon (106) having a proximal waist (at 116) fixedly secured to a distal end region of the shaft (col. 5, ll. 54-6 and col. 6, ll. 1-65). Lee discloses that the shaft includes a braid or coil extending from the hub to the proximal waist of the balloon (106 is a braided member as per claim 14, 15 of Lee, and extends from hub to proximal waist of balloon; fig. 2). Lee further discloses that the braided torqueable shaft (106) is configured to transmit a 1:1 torque ratio to a distal tip of the catheter when a steering force is applied from an adapter (hub 112) coupled to a proximal end of the elongated shaft. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Schaeffer to construct the torqueable shaft as a braided member extending from the hub to a proximal waist of the ballon and configured to transmit a 1:1 torque ratio from the hub to the balloon in view of Lee in order to allow the user to accurately control the corresponding amount of rotation of the distal end of the device based on rotation at the proximal end that is accessible to the user. Regarding claims 2 and 3, since the shaft transmits a 1:1 torque ratio from the hub to the balloon, a given angle of rotation of the hub of the catheter of Schaeffer as modified by Lee will result in an angle of rotation of the balloon that is the same as the given angle of rotation, and thus within 10 percent of the given angle of rotation.
Schaeffer in view of Zhu and Lee makes obvious rotating the hub in order to achieve a corresponding rotation of the balloon, but does not expressly disclose rotating the hub and balloon through a given angle of rotation of between 30 degrees to 75 degrees.
Giasolli discloses another method for treating lesions within a blood vessel, the method including inflating an inflatable balloon (20; fig. 1a) having a plurality of traction elements (16/26; fig. 9a) used to crack the lesion (figs. 23F.1). Giasolli discloses rotating the balloon through an angle of rotation of between 30 degrees to 75 degrees (45 degrees; [0007]) and reinflating the balloon in order to create new serrations along the vessel wall where there were none previously. It would have been obvious to one ordinary skill in the art to have rotated the hub and balloon of Schaeffer (noting 1:1 torque ration from hub to balloon as taught by Lee) a given angle of rotation of between 30 degrees to 75 degrees in view of Giasolli’s teaching that such rotation is known in the art and merely leads to the predictable result of applying new cracks in the lesion where there were none previously, thus ensuring complete opening of the blood vessel.
Regarding claim 7, the lesion is an eccentric lesion as shown in fig. 6A-6C, and appears to extend less than 180 degrees around the vessel wall, but the exact circumferential extent of the lesion is unclear. See also paragraph [0004], which discusses treatment of eccentric lesions. It would have been obvious to one of ordinary skill in the art to have treated an eccentric lesion extending less than 180 degrees around the vessel wall using the device and method of Schaeffer since Schaeffer discloses using the device to treat eccentric lesions (figs. 6A-6C) and treatment of a lesion having the claimed circumferential extent would merely lead to the predictable result of scoring the lesion to facilitate dilation in the same manner as a lesion extending more than 180 degrees around the vessel .
Regarding claim 21, Schaeffer discloses a method of treating an eccentric lesion within a blood vessel (see [0002], [0004], [0027]; figs. 6A-6C), the method comprising advancing a catheter through the vessel to a treatment site proximate the eccentric lesion (see fig. 6A, noting bodily passage may be a blood vessel), the catheter including a torqueable shaft (20; as understood in view of arrows in fig. 6C, rotation of shaft results in rotation of balloon; [0074]) extending from a hub (see enlarged end 27 that includes side port: figs. 6a-c) fixedly secured to a proximal end region of the shaft to an inflatable balloon (40) fixedly secured to a distal end region of the shaft, the catheter including a plurality of cutting blades (50; see [0045], [0051], [0056] – has sharp cutting edge) mounted on an exterior of the inflatable balloon, wherein the inflatable balloon is adapted to urge the plurality of cutting blades outwardly when the inflatable balloon is inflated; thereafter inflating the inflatable balloon to urge one or more of the cutting blades radially outwardly into contact with the eccentric lesion ([0059]), thereafter deflating the inflatable balloon ([0059]), thereafter rotating the hub of the catheter to achieve a corresponding rotation of the balloon of the catheter relative to the treatment site (see [0059] and note arrows in fig. 6C; it would have been obvious to rotate the catheter and balloon via the hub as the hub is external to the body and provides a handle), and thereafter, re-inflating the balloon to urge one or more of the plurality of cutting blades radially outwardly into contact with the lesion ([0059]).
As understood in view of at least [0025] and [0082], which discloses “aligning the one or more raised elements with the portion of the bodily passage intended to be treated by the catheter”, and paragraph [0004], which discloses the desire to direct the traction elements to the area of an eccentric lesion that needs to be cut while avoiding healthy tissue, it would have been obvious to concurrently engage the lesion with at least two of the traction elements during the step of inflating the inflatable balloon and/or during the step of re-inflating the inflatable balloon for the predictable result of providing multiple score/cut lines in the lesion while avoiding scoring/cutting adjacent healthy tissue. See also paragraph [0051], which includes that more rows of traction elements may be provided and each row may a plurality of discrete traction elements as opposed to a single elongated traction element. The lesion is an eccentric lesion as shown in fig. 6A-6C, and appears to extend less than 180 degrees around the vessel wall, but the exact circumferential extent of the lesion is unclear. It would have been obvious to one of ordinary skill in the art to treat an eccentric lesion extending less than 180 degrees around the vessel using the device and method of Schaeffer since Schaeffer discloses using the device to treat eccentric lesions and treatment of a lesion having the claimed circumferential extent would merely lead to the predictable result of scoring the lesion to facilitate dilation in the same manner as a lesion extending more than 180 degrees around the vessel.
Schaeffer discloses that urging the first and second cutting blades radially outwardly into contact with the eccentric lesion causes the lesion to crack (lesion is cut or scored as per [0028] and [0059], which is considered to read on “crack”), but Schaeffer does not expressly disclose that urging the first and second cutting blades radially outward into contact with the lesion causes the eccentric lesion to crack at a location between the first and second cutting blades.
Zhu discloses that the calcification expansion ability of a cutting balloon is higher when two blades face the calcification than when only one blade does (abstract). Zhu further discloses that such an arrangement lowers the stress on parts of the vessel wall circumferentially adjacent the eccentric calcification (i.e., the healthy tissue on either side of the eccentric calcification; see “Discussion”; page 10, 11). Zhu further discloses that the maximum principle tensile stress experienced by the lesion falls between the two blades as shown in fig. 7 (page 10), and maximum principle tensile stress is associated with plaque rupture (see “results” section on page 5). Thus, it would have been obvious to one ordinary skill in the art to have positioned first and second cutting blades of the balloon of Schaeffer such that they both face the calcification in a manner that the maximum principle tensile stress experienced by the lesion falls between the first and second blades, thus causing cracking of the lesion between the first and second blades, particularly in cases where the lesion is radially thinner at a location between the two blades, in view of the prior art of Zhu since such an arrangement increases the expansion ability of the cutting balloon while simultaneously lowering stress on parts of the vessel wall adjacent the calcification as compared to when a single blade faces the lesion.
Schaeffer in view of Zhu makes obvious the invention substantially as stated above including rotating the hub in order to achieve a corresponding rotation of the balloon of the catheter via a torqueable shaft extending between the hub and the proximal waist of the balloon (see figs. 6A-C and [0059]), but does not expressly disclose that the torqueable shaft includes a braid or coil extending from the hub to a proximal waist of a balloon, and that, for a given angle of rotation of the hub of the catheter, the balloon of the catheter rotates in the same direction an angle of rotation that is within 20 or 10 percent of the given angle of rotation.
Lee discloses another balloon catheter comprising a torqueable shaft (106) having a hub (112; fig. 2) fixedly secured to a proximal end region of the shaft and a balloon (106) having a proximal waist (at 116) fixedly secured to a distal end region of the shaft (col. 5, ll. 54-6 and col. 6, ll. 1-65). Lee discloses that the shaft includes a braid or coil extending from the hub to the proximal waist of the balloon (106 is a braided member as per claim 14, 15 of Lee, and extends from hub to proximal waist of balloon; fig. 2). Lee further discloses that the braided torqueable shaft (106) is configured to transmit a 1:1 torque ratio to a distal tip of the catheter when a steering force is applied from an adapter (hub 112) coupled to a proximal end of the elongated shaft. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Schaeffer to construct the torqueable shaft as a braided member extending from the hub to a proximal waist of the ballon and configured to transmit a 1:1 torque ratio from the hub to the balloon in view of Lee in order to allow the user to accurately control the corresponding amount of rotation of the distal end of the device based on rotation at the proximal end that is accessible to the user. Regarding claims 22 and 23, since the shaft transmits a 1:1 torque ratio from the hub to the balloon, a given angle of rotation of the hub of the catheter of Schaeffer as modified by Lee will result in an angle of rotation of the balloon that is the same as the given angle of rotation, and thus within 10 percent of the given angle of rotation.
Schaeffer in view of Zhu and Lee makes obvious rotating the hub in order to achieve a corresponding rotation of the balloon, but does not expressly disclose rotating the hub and balloon through a given angle of rotation of between 30 degrees to 75 degrees.
Giasolli discloses another method for treating lesions within a blood vessel, the method including inflating an inflatable balloon (20; fig. 1a) having a plurality of traction elements (16/26; fig. 9a) used to crack the lesion (figs. 23F.1). Giasolli discloses rotating the balloon through an angle of rotation of between 30 degrees to 75 degrees (45 degrees; [0007]) and reinflating the balloon in order to create new serrations along the vessel wall where there were none previously. It would have been obvious to one ordinary skill in the art to have rotated the hub and balloon of Schaeffer (noting 1:1 torque ration from hub to balloon as taught by Lee) a given angle of rotation of between 30 degrees to 75 degrees in view of Giasolli’s teaching that such rotation is known in the art and merely leads to the predictable result of applying new cracks in the lesion where there were none previously, thus ensuring complete opening of the blood vessel.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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KSH 7/27/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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