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 amendments requiring a transitional cut pattern comprising a progression in laser cut pattern configured to provide a gradual change in flexibility between the first segment and the second segment overcoming the previously presented 35 USC 103 rejections over Galdonik ‘476 in view of Galdonik ‘047 and Sepetka are persuasive. However, in view of the amendments, the prior art of Voeller et al. (US 2011/0245808) has been added to the rejections as presented below.
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, 9-12, 15 and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galdonik et al. (US 2010/0010476) in view of Galdonik et al. (US 2006/0200047), Voeller et al. (US 2011/0245808) and Sepetka (US 4,955,862). Galdonik ‘476 discloses an embolic protection device with a flexible fiber-based filter element comprising a core wire (106) having a proximal section with a first diameter, a distal section (130) having a diameter less than the first diameter (noting taper described in par. [0062]), and a tip section (132) having a non-circular section over at least a portion of its length ([0062]), a hypotube (108/150, 170 in fig. 8A) with a proximal section free of laser cuts and a distal section having laser cuts through the wall of the hypotube (see fig. 2a,b), the laser cut section comprising a first segment (segment comprising proximal half of 142; fig. 2a) having a first consistent cut pattern, a second segment (segment comprising distal half of 144) having a second consistent cut pattern, and a transition segment (segment comprising distal half of 142 and proximal half of 144) therebetween having a transitional cut pattern (i.e., it transitions along its length from the first consistent cut pattern to the second consistent cut pattern). The core wire extends through the hypotube with the proximal end and the distal end of the core wire extending from respective ends of the hypotube (fig. 1A), a torque coupler (114) restricting rotation of the core wire and the hypotube at the torque coupler while allowing at least some sliding of the core wire within the hypotube ([0075], [0076]), a fiber bundle (152; fig. 5) comprising a bundle of fibers each having a first end and a second end, a first attachment element (158/184), and a second attachment element (160/186), wherein the first attachment element secures the first ends of the fibers and the second attachment element secures the second ends of the fibers, wherein the first attachment element is secured to the distal section of the hypotube (similar to 174/184 in fig. 8A), wherein the fiber bundle has an initial undeployed configuration with the fibers aligned (fig. 6/8a) and a deployed configuration (fig. 7/8b) with the fibers bent and the core wire in a proximal position relative to the hypotube in the undeployed configuration. A distal tip (e.g., 112; fig. 1a) is secured with the second attachment element and/or to the corewire.
Although Galdonik ‘476 does not illustrate an uncut distal segment as claimed, Galdonik ‘476 incorporates by reference Galdonik ’047 in paragraph [0067] and states that “further detail on resilient members are disclosed in published US patent application 2006/0200047A…”. Galdonik ‘047 discloses that the resilient overtube may include an uncut distal segment (“unslotted portion”) distal to the slotted portion if useful for use with an associated medical device ([0108]). Thus, it would have been obvious to one of ordinary skill in the art to include an uncut distal segment distal of the claimed laser cut distal section (142/144) disclosed by Galdonik ‘476 in view of Galdonik’ 047 (which is incorporated by reference into Galdonik ‘476), which teaches that this can be useful for use with an associated medical device ([0108]).
Galdonik ‘476 also fails to disclose that the transition segment has a transitional cut pattern comprising a progression in laser cut pattern configured to provide a gradual change in flexibility between the first segment and the second segment.
Voeller discloses another hypotube (20) through which a corewire (24) extends, and further discloses that the hypotube comprises a laser cut first segment (56; fig. 6) having a first consistent cut pattern, a second segment (50; fig. 6) having a second consistent cut pattern, and a transition segment (54) therebetween having a transitional cut pattern comprising a progression in laser cut pattern configured to provide a gradual change in flexibility between the first segment and the second segment ([0046]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Galdonik ‘476 to include a transitional cut pattern comprising a progression in laser cut pattern configured to provide a gradual change in flexibility between the first segment and the second segment as taught by Voeller in order to ensure a device that has flexibility characteristics that allow the device to traverse the vasculature and navigate coronary artery take-offs, yet be sufficiently resistant to buckling ([0040]) by providing a smooth variation in flexibility rather than an abrupt change.
Galdonik ‘476 discloses that the use of a friction reducing layer between the core wire and at least a portion of the hypotube distal section ([0071]) to facilitate longitudinal motion of the corewire relative to the hypotube (note: longitudinal motion of the corewire is understood to be the same as lateral translation along a central axis of the hypotube), but does not expressly disclose that the friction reducing layer comprises a friction reducing coil.
Sepetka discloses another intravascular catheter. Sepetka discloses that a friction reducing layer (38; fig. 2) between a core wire (14) and a tube (16) surrounding the core wire may take the form of a friction reducing coil (abstract; col. 5, ll. 32-55; col. 10, ll. 25-32). The coil surfaces in contact with the core wire provide a series of hard, relatively nondeformable surface regions which substantially reduces friction between the wire and the lumen of tubular element (16) as the wire and tubular element move axially relative to each other (col. 10, ll. 25-32), and thus reduces a coefficient of friction between the core wire and the tube when the corewire translates laterally along a central axis of the tube. The coil is considered mechanically discrete from the core wire and the tube as it is a distinct structure from the core wire and the tube.
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Galdonik ‘476 to substitute a friction reducing coil as taught by Sepetka for the friction reducing layer (e.g., PTFE layer disclosed by Galdonik ‘476) positioned between the core wire and the hypotube since such a modification can be considered a substitution of one known friction reducing element positioned between two coaxial elements of a catheter device for lowering the coefficient of friction between the two coaxial elements when the inner element (corewire) translates laterally along the central axis of the outer element (hypotube) for another wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Regarding claim 9, Galdonik ‘476 discloses that the distal section (142; fig. 2b) of the hypotube, which extends to the distal end of the hypotube, is laser cut and discloses that this distal section may be “many inches long” ([0065]), but does not expressly disclose that the distal section is 4.5 inches (i.e., 90% of 5 inches). Applicant does not disclose any particular purpose served, problem solved, or advantage gained by the claimed length over any other length, disclosing only that “generally, in the laser cut segment of the hypotube, at least about 90% of the length is laser cut” ([0122] of the instant application’s publication US 2024/0415628). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Galdonik ‘476 to construct the distal section of the hypotube to be 4.5 inches since Galdonik ‘476 discloses that the laser cut distal section may be “many inches long”, and such a modification appears to be a mere design choice as there is no criticality disclosed for the claimed dimension.
Regarding claim 10, the corewire comprises an intermediate section between the proximal section and the distal section, the intermediate section having a third diameter intermediate between the first and second diameter, wherein transition sections smoothly connect the proximal, intermediate, and distal sections of the corewire (see fig. 1B, noting intermediate section may be within tapered portions 130 or 132; [0062]). The hypotube comprises an intermediate section between the proximal and distal sections of the hypotube.
Regarding claim 11, the fiber bundle comprises at least about 100 surface capillary fibers distributed around the circumference of the corewire ([0081], [0088] of Galdonik ‘476) with a twist of the distal end relative to the proximal end of at least about 90 degrees ([0096]) and wherein the distal tip (112) comprises a distal coil and a blunt tip (fig. 1A/1B and [0064]).
Regarding claim 12, the fiber bundle of Galdonik ‘476 comprises radiopaque metal elements ([0008]; see [0121], wherein radio-opacity can be achieved using platinum-iridium).
Regarding claim 15, the limitation “wherein the distal end has been mechanically stretched to increase flexibility” is considered a product-by-process limitation that is limiting only in so far as the final structure necessitated by the process. Since the process of stretching a distal end of a hypotube can result in myriad different final products depending on the material, wall thickness, and diameter of the hypotube that is stretched, the only final structure this product-by-process limitation is considered to necessitate is a hypotube.
Regarding claim 21, as taught by Voeller, the transition segment comprises laser cuts having parameters (axial spacing between cuts; location of uncut portions between circumferentially adjacent cuts) that gradually change from the first consistent cut pattern to the second consistent cut pattern along an axial length of the hypotube (fig. 6, [0043], [0046]).
Regarding claim 22, as taught by Voeller, the transition segment (54) includes a change in at least one of cut pitch, cuts-per-revolution, cut angle, or uncut angle between the first (56) and second (50) segments. In particular, the transition segment includes a change in pitch (space between axially adjacent cuts) between the first and second segments. (fig. 6 of Voeller)
Regarding claim 23, as taught by Voeller, the transition segment is configured to provide a progressive change in flexibility between the first and second segments (fig. 6, [0043], [0046]).
Claim(s) 13, 14, and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galdonik ‘476 in view of Galdonik ‘047, Voeller, and Sepetka as applied to claim 1 above, and further in view of Fahey et al. (US 2006/0100687). Galdonik ‘476 in view of Galdonik ‘047, Voeller, and Sepetka discloses the invention substantially as stated above including a hypotube (which may be metal; [0069]) which is laser cut and includes intermittent cuts (see fig. 2b), but does not expressly disclose that the hypotube has a spiral intermittent cut, or that the fraction of metal cut at a section near the distal end is greater than a section at a proximal end of the hypotube.
Fahey discloses another catheter having laser cuts to increase flexibility of the catheter. Fahey disclose a spiral intermittent cut (figs. 10-12) as an alternative to a circumferential intermittent cut (figs. 13, 14) used to enhance flexibility. Fahey further discloses that the pitch (i.e., axial distance between adjacent turns of the spiral cut) may be smaller at the distal end of the cut than at its proximal end in order to provide increasing flexibility along the length of the cut ([0019]). Thus, the fraction of metal cut at a section near the distal end is greater than a section at a proximal end of the laser cut hypotube to introduce greater flexibility at the distal end. It would have been obvious to one of ordinary skill in the art to have modified the prior art of Galdonik ‘476 to include a spiral intermittent cut having a fraction of metal cut at a section near the distal end greater than a section at the proximal end as taught by Fahey since an intermittent spiral intermittent cut is a known alternative to a circumferential intermittent cut and the decreasing pitch facilitates greater flexibility at the distal end where it is most desirable.
Regarding claim 16, as a result of the intermittent spiral cut in the hypotube of Galdonik ‘476 as modified by Fahey, pushing the corewire of Galdonik ‘476 in a distal direction from an undeployed filter configuration (i.e., undeployed configuration of fiber bundle) results in bending of the device along the length of the laser cut hypotube in the same manner as the instant invention. (Note: instant application states that, when a significate portion of the hypotube is laser cut with an intermittent spiral cut, extending the corewire in a distal direction when the filter is not deployed results in a curvature of the integrated guide structure along the laser cut segment of the hypotube (see [0100] of US 2024/0415628). Because the structure disclosed by Galdonik ‘476 in view of Galdonik ‘047, Voeller, Sepetka and Fahey is the same as the claimed structure, the examiner maintains that the hypotube of modified Galdonik ‘476 will bend in the same manner as that of the instant invention)
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galdonik ‘476 in view of Galdonik ‘047, Voeller, and Sepetka as applied to claim 1 above, and further in view of Strauss et al. (US 2012/0116350). Galdonik ‘476 in view of Galdonik ‘047, Voeller, and Sepetka discloses the invention substantially as stated above but fails to disclose a reflowed thermoplastic elastomer over at least a portion of the laser cut hypotube as claimed.
Strauss discloses another laser cut hypotube (104) that forms part of an intravascular catheter system. Strauss discloses reflowed thermoplastic elastomer (102) over at least a portion of the laser cut hypotube, wherein the reflowed thermoplastic elastomer extends into the laser cuts (see 35 USC 112b rejection above) in order to bind the elastomer to an inner layer (106) of the catheter system ([0019], [0043]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Galdonik ‘476 to include reflowed thermoplastic elastomer over at least a portion of the laser cut hypotube, wherein the reflowed thermoplastic elastomer extends into the laser cuts, as taught by Strauss in order to provide a smooth outer surface to the hypotube and facilitate bonding of the outer layer with an inner layer, thus minimizing tissue trauma as the device is advanced through vasculature and enhancing the bond between different layers of the hypotube.
Claim(s) 2 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galdonik ‘476 in view of Galdonik ‘047, Voeller, and Sepetka as applied to claim 1 above, and further in view of Galdonik et al. (US 7,988,705: “Galdonik ‘705”). Galdonik ‘476 in view of Galdonik ‘047, Voeller, and Sepetka discloses the invention substantially as stated above including a torque coupler, but does not disclose a stake as part of the torque coupler.
Galdonik ‘705 discloses a similar embolic protection device with a torque coupler. As an alternative to a torque coupler in which the core wire and hypotube have asymmetric cross sections along a portion of their lengths, Galdonik ‘705 discloses a stake (132/134, which may be formed from a different material from the tube as per col.10, ll. 45-59 and thus stake 132/134 is considered a distinct element from the hypotube) attached to the hypotube. The stake has a channel (noting space between portions 132/134 of the stake) with an asymmetry (noting flat surfaces 136,138) of a cross section of a surface of the channel (wherein rest of channel surface is formed by rounded wall of hypotube 130) around an axis of the corewire, and wherein the corewire comprises a segment with an asymmetric key structure that interfaces with the channel of the stake to form the torque coupler restricting relative rotation of the corewire and the hypotube without restricting sliding of the corewire within the hypotube over the segment of the corewire (col. 11, ll. 16-32). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Galdonik ‘476 to include a torque coupler having the stake structure of claim 2 as taught by Galdonik ‘705 since such a modification can be considered a substitution of one known torque coupler configuration (stake attached to hypotube, the stake having asymmetry that interfaces with key structure of core wire as taught by Galdonik ‘705) for another (hypotube itself has asymmetry that interfaces with key structure of core wire as disclosed by Galdonik ‘476) wherein the results are predictable and one skilled in the art would have had a reasonable expectation of success.
Regarding claim 5, the orientation of the first and second attachment elements provide a twist to the fiber bundle ([0096] of Galdonik ‘476) which is maintained by the torque coupler since the torque coupler prevents relative rotation between the core wire and the hypotube.
Allowable Subject Matter
Claims 3, 4, 7, and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 17-20 are allowed. The closest prior art of Galdonik ‘476 in view of Galdonik ‘0747, Voeller, Sepetka and Galdonik ‘705 (see discussions above) fails to disclose or fairly suggest, in combination with the remaining claim limitations, attaching the stake to the hypotube distal to the friction reducing coil.
Conclusion
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.
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KSH 4/22/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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