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 filed 3/30/2026 with respect to the amendments overcoming the previously presented rejections over Kovach ‘807 in view of Goepfrich have been fully considered but they are not persuasive. Applicant asserts that Kovach ‘807 does not disclose an expanded nominal diameter of the balloon being larger than a nominal device diameter of the implantable device, as is now required by amended claim 1. This is not found persuasive as the nominal diameter of the balloon may be 8mm according to Kovach ‘807, while the nominal diameter of the implantable device, considered the diameter at which the stent resists further expansion, is 7mm. See [0061]-[0064]. Applicant notes that Kovach ‘807 does not expressly disclose the diameter of the balloon when the device is expanded to 7mm. However, the expansion of the stent is caused by expansion of the balloon on which the stent is mounted. When the stent is expanded to 7mm (its nominal diameter defined by its stop point), the balloon underneath the stent is understood to be expanded to about 7mm. As disclosed by Kovach ‘807, the stent is designed to resist expansion beyond its stop point, i.e., its nominal device diameter. The balloon, with the stent thereon, cannot be expanded to a greater diameter than that of the stent mounted thereon (at least along the portion of the balloon on which the stent is mounted).
Applicant also asserts that Goepfrich discloses balloons that are smaller than the implantable device and thus does not address oversizing the balloon compared to the medical device in the claimed manner. The examiner respectfully disagrees with this assertion, noting that the citation quoted by applicant refers to a balloon that has a high amount of expansion such that the delivery diameter of the balloon is much smaller than the nominal balloon diameter in order to provide a reduced delivery profile. This citation is not considered to teach away from any particular sizing of a balloon relative to the implantable device used with the balloon, including a balloon having a nominal diameter larger than that of an implantable device used with the balloon. It is further noted that Goepfrich was not relied upon for any teaching of a particular sizing of the nominal device diameter or expanded nominal balloon diameter.
Claim Objections
Claims 31 and 35 are objected to because of the following informalities.
Claim 31, line 3: “inflation” should read “expansion” for consistency with claim 1.
Claim 35, line 2: “nominal diameter of the device” should read “nominal device diameter
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, 5-6, 8-10, 23-24, 30-32, and 34-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovach (US 2013/0184807) in view of Goepfrich (US 2014/0172066).
Kovach ‘807 discloses a system for delivery of an implantable medical device, the system comprising an implantable medical device (covered stent; abstract) having a delivery diameter and a nominal device diameter, the implantable medical device capable of expanding from the delivery diameter to the nominal device diameter sized for implantation (expanded diameter at which stent is highly resistant to further distension is considered the claimed nominal device diameter, which may be 7, 8, 9, or 10 mm; [0040]; [0064] specifically discloses a stop point of 7mm), wherein the implantable medical device resists expansion beyond the nominal device diameter ([0040]), wherein the nominal device diameter (expanded diameter discussed above) is larger than the delivery diameter (unexpanded diameter), a delivery catheter (balloon catheter of par. [0051]) comprising a balloon expandable from a delivery balloon diameter to an expanded nominal balloon diameter (8mm; [0062]) larger than the delivery balloon diameter (deflated diameter of balloon is considered the delivery ballon diameter, noting inflation of balloon causes expansion of stent mounted thereon in [0051]-[0053] and thus balloon diameter expands during inflation), wherein the expanded nominal balloon diameter is less than a maximum expanded balloon diameter (i.e., balloon diameter just before bursting), wherein the implantable medical device is mounted on the balloon ([0051]). The implantable medical device is configured to maintain the nominal device diameter (7mm; [0064]) while mounted on the balloon and the balloon is maintained at the nominal device diameter (stent’s stop point diameter of 7mm; balloon can’t expand greater than 7mm if stent mounted thereon is maintained at 7mm), which is smaller than the expanded nominal balloon diameter (8mm), at a nominal inflation pressure. Noting that the implantable medical device is highly resistant to further distension once nominal device diameter is achieved according to Kovach ‘807 ([0040]), the implantable device, which stops expanding at 7mm according to [0064], will prevent the balloon from continuing expansion to its expanded nominal balloon diameter.
Kovach ‘807 does not expressly disclose a cover disposed over at least a portion of the balloon as claimed.
Goepfrich discloses another balloon catheter that can be used to deliver a stent (160; fig. 4e), the balloon catheter having a cover (130) that restricts expansion of the balloon (120) beyond the nominal balloon diameter, the cover disposed over at least a portion of the balloon (abstract; figs. 4a,4b, 7a,7b; claim 39). The cover is radially distensible up to a stop point (50) that restricts expansion of the balloon past the expanded nominal balloon diameter when inflated at a relatively constant inflation pressure (abstract; [0058]; figs. 7a,7b; claim 39), noting that the balloon has a maximum expanded balloon diameter larger than the nominal balloon diameter if the force is markedly increased ([0009]; fig. 7b). The cover comprises serpentine fibrils (fig. 1, 2; [0020], [0051]), such that the cover is configured to stretch longitudinally and radially during substantially continuous expansion from the delivery balloon diameter to the expanded nominal balloon diameter ([0001], [0017]), [0047], [0054]), which allows for high elongation upon application of a force in a direction opposite to the compressed direction ([0065]). The cover prevents over expansion of the balloon, thereby preventing vessel damage ([0058]), and facilitates achieving a more uniform or even inflation ([0052]). It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kovach ‘807 to include a cover on the balloon, the cover configured to stretch during substantially continuous expansion from the delivery balloon diameter to the expanded nominal balloon diameter as taught by Goepfrich in order to facilitate more uniform, even inflation and to prevent unintended over-extension of the balloon beyond its expanded nominal balloon diameter ([0058], [0052]).
Regarding claim 2, the expanded nominal balloon diameter is at the nominal inflation pressure of less than about 8 atm when the implantable medical device is mounted on the balloon (see fig. 4 of Kovach ‘807, noting pressure at stop point 70 is less than 8 atm).
Regarding claim 3, the expanded nominal balloon diameter is larger than the nominal device diameter (expanded nominal balloon diameter may be 8mm, while nominal device diameter may be according to Kovach ‘807), but does not expressly disclose that the expanded nominal balloon diameter is from 3.5 to 10% larger that the nominal device diameter. However, it would have been obvious to modify the prior art of Kovach to construct the balloon and stent such that the expanded nominal balloon diameter is from 3.5 to 10% larger than the nominal device diameter .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 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, 468 U.S. 830, 225,SPQ 232 (1984). In the instant case, the prior art of Kovach ‘807 as modified by Goepfrich would not perform differently as both the dimension disclosed by Kovach ‘807 and the claimed dimension provide the benefits associated with having an expanded nominal balloon diameter larger than the nominal device diameter, further noting applicant does disclose any criticality for the claimed range.
Regarding claims 5 and 6, the expanded nominal balloon diameter is considered about 7.5 mm as understood in view of fig. 4 of Kovach ‘807, noting the diameter at the stop point appears to be just over 7mm, and Kovach ‘807 also discloses that the balloon may be an 8mm balloon, which is considered to read on about 7.5mm.
Regarding claims 8-10, as taught by Goepfrich, the cover comprises an elastomer having serpentile fibrils (fig. 1, 2; abstract; [0020], [0051]) and is distensible in a radial and axial direction ([0001], [0018], [0047], [0054]).
Regarding claims 23 and 30, the cover taught by Goepfrich is disposed over at least a portion of the balloon and is configured to longitudinally stretch during expansion as noted above ([0017], [0019], [0025] of Goepfrich). The cover of the system of Kovach ‘807 as modified by Goepfrich is configured to impart a longitudinal lengthening force onto the implantable medical device during expansion and substantially continuous inflation of the balloon since the stent is mounted directly on the longitudinally lengthening cover.
Regarding claim 24, the expanded nominal balloon diameter is at least 3.5% larger than the nominal device diameter (8mm versus 7mm as disclosed by Kovach ‘807).
Regarding claim 31, the implantable medical device resists expansion beyond the nominal device diameter during the substantially continuous inflation as disclosed by Kovach ‘807 ([0040], [0041]).
Regarding claim 32, Goepfrich further teaches that the cover is taut at a diameter less than the expanded nominal balloon diameter and the cover continues to stretch toward the expanded nominal balloon diameter when taut (wherein a wrinkle free cover is considered “taut”; [0003], [0068]; see [0056], [0072], [0073]– cover is constructed at the delivery diameter, or less than the delivery diameter, with no folding/pleating, and thus taut when at a diameter less than the nominal balloon diameter). It is further noted that the instant specification discloses that the material of the claimed cover may be that disclosed in Goepfrich (see [0061] of the printed publication of the instant application: US 2021/0236314).
Regarding claim 34, the cover taught by Goepfrich is configured to expand with the balloon and facilitate uniform expansion of the balloon during inflation (see [0021], [0052]).
Regarding claim 36, the implantable medical device includes a stent and a graft coupled to a surface of the stent (“covered stent” according to Kovach ‘807, noting par. [0009]; see also [0018]).
Regarding claim 35, as noted above, the nominal diameter of the stent is 7mm according to Kovach ‘807 (see fig. 4 and [0061]-[0064], noting stop point of 7mm in [0064]). As taught by Goepfrich, the term “nominal diameter” refers to the diameter of the balloon when it has been circumferentially distended up to its stop point, and the nominal diameter is typically the labelled diameter ([0009]). Thus, one skilled in the art would understand Kovach ‘807’s description of “an 8 mm balloon” ([0062]) to be its labelled diameter, which corresponds to its nominal diameter (i.e., stop point). The diameter of the balloon at its stop point (8mm) is greater than the nominal diameter of the device (stent: 7mm) and less than a maximum expanded balloon diameter (noting balloon, with its cover as taught by Goepfrich, can be expanded beyond its stop point diameter with a large increase in pressure as understood in view of fig. 7B of Goepfrich).
Claim(s) 12, 26-29 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kovach ‘807 in view of Goepfrich and Bei et al. (US 2008/0140051).
Kovach ‘807 discloses a balloon catheter comprising a catheter and balloon mounted on the catheter (balloon catheter mentioned in [0051]), the balloon expandable from a delivery balloon diameter (deflated diameter) to an expanded nominal diameter (e.g., 8mm; [0062]) larger than the delivery balloon diameter and less than a maximum expanded balloon diameter (i.e., diameter right before bursting) and having a nominal inflation pressure when the balloon is at the expanded nominal balloon diameter, and a medical device (covered stent; [0064]) mounted on the balloon and having a nominal device diameter (7mm; [0064]), wherein the medical device resists expansion beyond the nominal device diameter ([0064; abstract). The medical device is configured to maintain the nominal device diameter while mounted on the balloon, and the balloon is maintained at the nominal device diameter at the nominal inflation pressure. In other words, the stent resists expansion past its nominal device diameter. Since the stent is mounted on balloon, the balloon cannot expand past the nominal device diameter. Kovach ‘807 discloses that the expanded nominal balloon diameter of the balloon (8mm balloon as per [0062]) is at least about 5% greater than the nominal device diameter (7mm; [0064]). Kovach ‘807 does not expressly disclose a cover disposed over at least a portion of the balloon as claimed.
Goepfrich discloses another balloon catheter that can be used to deliver a stent (160; fig. 4e), the balloon catheter having a cover (130) disposed over at least a portion of the balloon that restricts expansion of the balloon (120) beyond the nominal balloon diameter during substantially continuous inflation from the delivery balloon diameter to the expanded nominal balloon diameter (abstract; figs. 4a,4b; claim 39). The cover is radially distensible up to a stop point that restricts expansion of the balloon past the expanded nominal balloon diameter when inflated at a relatively constant inflation pressure (abstract; [0058]; figs. 7a,7b; claim 39). Regarding claims 27 and 28, the cover comprises ePTFE (see at least [0001], [0048]) and is configured to stretch in at least one of a radial dimension and a longitudinal dimension ([0020]). The cover prevents over expansion of the balloon, thereby preventing vessel damage ([0058]), and facilitates achieving a more uniform or even inflation of the balloon ([0052]).
It would have been obvious to one of ordinary skill in the art to have modified the prior art of Kovach ‘807 to include a cover configured to stretch during substantially continuous expansion from the delivery balloon diameter to the expanded nominal balloon diameter, the cover radially distensible up to a stop point that restricts expansion of the balloon past the expanded nominal balloon diameter when inflated at a relatively constant inflation pressure as taught by Goepfrich, in order to facilitate more uniform, even inflation of the balloon and to prevent unintended over-extension of the balloon beyond its expanded nominal balloon diameter ([0058]).
Kovach ’807 does not expressly disclose that the nominal inflation pressure of the balloon is about 6 atm when the medical device is mounted on the balloon, and instead discloses a pressure of about 7atm (fig. 4) or about 9atm ([0064]). However, Bei discloses that, for a balloon having an inflated working diameter between 2 and 10mm ([0052]), which encompasses the nominal inflation diameter of the balloon of Kovach ‘807 (8mm), a nominal inflation pressure of 6 atm is sufficient to expand a stent thereon without rupturing ([0040]). It would have been obvious to have constructed the balloon of Kovach ‘807 such that the nominal inflation pressure is 6 atm since, according to Bei, a balloon having a 6 atm nominal inflation pressure provides sufficient pressure to radially expand a stent having an inflated working diameter between 2 and 10mm mounted thereon without rupturing.
Regarding claim 26, the medical implant of Kovach ‘807 exhibits foreshortening less than 20% when it remains in its unexpanded configuration or is only slightly expanded for example, noting that the claim does not include any parameters for when the claimed range must occur. However, it is noted that Kovach ‘807 expressly discloses that the medical device exhibits minimal foreshortening during the expansion process prior to over-distension ([0041]).
Regarding claim 29, Goepfrich teaches that the balloon is folded in a non-expanded state ([0095]) and the cover is substantially free of folds in the non-expanded cover state (see [0065] of Goepfrich – cover made of ePTFE with serpentile fibrils has no visible pleating or folding).
Regarding claim 33, Goepfrich further teaches that the cover is taut at a diameter less than the expanded nominal balloon diameter and the cover continues to stretch toward the nominal balloon diameter when taut (wherein a wrinkle free cover is considered “taut”; [0003], [0069]; see [0056], [0072], [0073]– cover is constructed at the delivery diameter, or less than the delivery diameter, with no folding/pleating, and thus taut when at a diameter less than the nominal balloon diameter).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 5/28/2026
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771
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