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 .
Status of the Claims
Claims 1-20 are pending in the application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 7, 10-12, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gunderson et al. (US 2016/0081711 A1) (“Gunderson”).
Regarding claim 1, Gunderson discloses (Figures 1-12) a medical device, comprising: a catheter shaft (24, 26) having a distal region; an inflatable balloon (16) secured to the distal region; and a blade and pad assembly extending longitudinally relative to the inflatable balloon (Figure 2), the blade and pad assembly comprising a polymeric pad (38) adapted to be adhesively secured to an outer surface of the inflatable balloon (paragraph 0044) and a blade member (20) partially embedded within the polymeric pad (Figures 3A and 3B; paragraphs 0044-0046, 0049, 0052, 0058, 0059, 0066, 0072, 0076, 0079); the blade member comprising: a base portion (42) extending from a first end of the blade member to a second end of the blade member; a blade portion (44, 46/48) extending outwardly from the base portion (42), the blade portion including: a first blade flex point; a second blade flex point; a first blade segment extending from the first end of the blade member to the first blade flex point; a second blade segment extending from the second end of the blade member to the second blade flex point; and an intermediate blade segment extending between the first blade flex point and the second blade flex point (Figures 4-12 depict various blade portions with flex points and segments as claimed); and the polymeric pad comprising: a first pad flex point aligned with the first blade flex point; and a second pad flex point aligned with the second blade flex point (paragraphs 0049, 0052, 0058, 0059, 0066, 0072, 0076, 0079).
Regarding claim 2, Gunderson discloses (Figure 7) the first blade flex point (464) comprises a first gap in the blade portion (444); and the second blade flex point comprises a second gap (464) in the blade portion, with the base portion (442) extending without any gap (NOTE: Gunderson discloses that slots 450 and tabs 460 are embedded in the polymeric pad).
Regarding claim 7, Gunderson discloses (Figures 3A and 3B) that the polymeric pad (38) tapers from a maximum thickness where the blade member is embedded in the polymeric pad (at 42) to a minimum thickness along either edge of the polymeric pad parallel with the blade member (see Figure 3B annotated below).
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Regarding claim 10, Gunderson discloses (Figure 1) one or more additional blade and pad assemblies extending longitudinally relative to the inflatable balloon, each of the one or more additional blade and pad assemblies comprising: a blade member (20) comprising: a base portion (36) extending from a first end of the blade member to a second end of the blade member; a blade portion (44, 46/48) extending outwardly from the base portion, the blade portion including: a first blade flex point; a second blade flex point; a first blade segment extending from the first end of the blade member to the first blade flex point; a second blade segment extending from the second end of the blade member to the second blade flex point; and an intermediate blade segment extending between the first blade flex point and the second blade flex point (Figures 4-12 depict blade portions with flex points and segments as claimed); and a polymeric pad (38) adapted to be adhesively secured to the outer surface of the inflatable balloon (paragraph 0044) with the blade member partially embedded within the polymeric pad (Figures 3A and 3B; paragraphs 0044-0046, 0049, 0052, 0058, 0059, 0066, 0072, 0076, 0079), the polymeric pad comprising: a first pad flex point aligned with the first blade flex point; and a second pad flex point aligned with the second blade flex point (paragraphs 0049, 0052, 0058, 0059, 0066, 0072, 0076, 0079).
Regarding claim 11, Gunderson discloses (Figures 1-12) a medical device, comprising: an inflatable balloon (16) secured to a distal region of a catheter shaft (24, 26) having a longitudinal axis; a plurality of blade (20) and pad assemblies (38) secured to the inflatable balloon and extending longitudinally with respect to the inflatable balloon, each of the plurality of blade and pad assemblies having a longitudinal axis and comprising: a polymeric pad (38) adapted to be secured to the inflatable balloon (paragraphs 0044-0046); and two or more blade segments secured within the polymeric pad (Figures 3A and 3B), the two or more blade segments separated by one or more blade flex points (Figures 4-12 depict multiple configurations with two or more blade segments separated by one or more blade flex points); the polymeric pad comprising one or more pad flex points aligned with the one or more blade flex points (paragraphs 0049, 0052, 0058, 0059, 0066, 0072, 0076, 0079).
Regarding claim 12, the one or more pad flex points disclosed by Gunderson are adapted to facilitate side bending of the corresponding polymeric pads (paragraphs 0044-0046, 0081).
Regarding claim 15, each of the one or more pad flex points disclosed by Gunderson are adapted to allow adjacent polymeric pads to nest together when the inflatable balloon is deflated and folded (paragraph 0038).
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.
Claims 3-6, 13, 14, 16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2016/0081711 A1) (“Gunderson”) in view of Haverkost et al. (US 2019/0307992 A1) (“Haverkost”).
Regarding claims 3-6, Gunderson discloses the invention substantially as claimed. However, Gunderson fails to disclose the first pad flex point comprises a first region of the polymeric pad having a reduced pad width, wherein the first region of the polymeric pad has a width that is reduced 30 to 70 percent relative to a width of the polymeric pad outside of the first region; and the second pad flex point comprises a second region of the polymeric pad having a reduced pad width, wherein the second region of the polymeric pad has a width that is reduced 30 to 70 percent relative to a width of the polymeric pad outside of the second region.
In the same field of endeavor, Haverkost teaches (Figure 11) a polymeric frame (208) for attaching a blade member to the outer surface of a balloon (202). Haverkost teaches that the frame includes flex points (252) that comprise regions of the frame that have a reduced width (262). Haverkost teaches that the regions of reduced width have a width (262) that is reduced 30 to 70 percent relative to a width (260) of the frame (238) outside the reduced width (paragraph 0141). Haverkost teaches that the reduced width portions flex/bend/pivot relative to the blade mounting modules (238) so the expandable frame may move between a collapsed generally linear configuration and an expanded configuration generally conforming to an outer shape of the balloon (paragraph 0141).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first pad flex point to comprise a first region of the polymeric pad having a reduced pad width, wherein the first region of the polymeric pad has a width that is reduced 30 to 70 percent relative to a width of the polymeric pad outside of the first region, as taught by Haverkost; and to modify the second pad flex point comprises a second region of the polymeric pad having a reduced pad width, wherein the second region of the polymeric pad has a width that is reduced 30 to 70 percent relative to a width of the polymeric pad outside of the second region, as taught by Haverkost. Haverkost teaches that a reduction in width results in a more flexible flex point that can bend/flex/pivot to conform to the outer shape of the balloon (Haverkost, paragraph 0141).
Regarding claims 13 and 14, Gunderson discloses the invention substantially as claimed. However, Gunderson fails to disclose the one or more pad flex points comprise an increased-flexibility portion of the corresponding polymeric pad and each of the one or more pad flex points comprise a narrowed portion of the corresponding polymeric pad.
In the same field of endeavor, Haverkost teaches (Figure 11) a polymeric frame (208) for attaching a blade member to the outer surface of a balloon (202). Haverkost teaches that the frame includes flex points (252) with an increased flexibility that comprise regions of the frame that comprise a narrowed portion with a reduced width (262).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify each of the one or more pad flex points to comprise an increased-flexibility portion of the corresponding polymeric pad and each of the one or more pad flex points comprise a narrowed portion of the corresponding polymeric pad, as taught by Haverkost. Haverkost teaches that a narrowed portion with a reduction in width results in a more flexible flex point that can bend/flex/pivot to conform to the outer shape of the balloon (Haverkost, paragraph 0141). These modifications would result in a polymeric pad that better conforms to the outer shape of the balloon.
Regarding claim 16, Gunderson discloses the invention substantially as claimed. However, Gunderson fails to disclose that each of the one or more pad flex points comprise a scalloped portion of the polymeric pad. NOTE: “scalloped” is defined as “having an edge consisting of a row of curves” (Cambridge Dictionary).
In the same field of endeavor, Haverkost teaches (Figure 11) a polymeric frame (208) for attaching a blade member to the outer surface of a balloon (202). Haverkost teaches that the frame includes alternating blade mounting modules (238) and reduced width (262) flex points (252) with an increased flexibility forming a scalloped portion of the frame.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify each of the one or more pad flex points to comprise a scalloped portion of the polymeric pad, as taught by Haverkost. This modification would provide reduced width flex points with an increased flexibility that can bend/flex/pivot to conform to the outer shape of the balloon (Haverkost, paragraph 0141).
Regarding claim 20, Gunderson teaches the invention substantially as claimed. However, Gunderson fails to teach that each of the one or more pad flex points comprise a region of the polymeric pad having a width that is reduced 30 to 70 percent relative to a width of the polymeric pad away from the pad flex point.
In the same field of endeavor, Haverkost teaches (Figure 11) a polymeric frame (208) for attaching a blade member to the outer surface of a balloon (202). Haverkost teaches that the frame includes flex points (252) that comprise regions of the frame that have a reduced width (262). Haverkost teaches that the regions of reduced width have a width (262) that is reduced 30 to 70 percent relative to a width (260) of the frame (238) outside the reduced width (paragraph 0141). Haverkost teaches that the reduced width portions flex/bend/pivot relative to the blade mounting modules (238) so the expandable frame may move between a collapsed generally linear configuration and an expanded configuration generally conforming to an outer shape of the balloon (paragraph 0141).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify each of the one or more pad flex points to comprise a region of the polymeric pad having a width that is reduced 30 to 70 percent relative to a width of the polymeric pad away from the pad flex point, as taught by Haverkost. Haverkost teaches that a reduction in width results in a more flexible flex point that can bend/flex/pivot to conform to the outer shape of the balloon (Haverkost, paragraph 0141).
Claims 8, 9, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2016/0081711 A1) (“Gunderson”).
Regarding claim 8, Gunderson discloses that the outer surface of the balloon, when the balloon is inflated, has a balloon radius of curvature. Gunderson discloses that the polymeric pad (38) has a mounting surface that closely conforms to the expansion characteristics of the balloon. Figures 3A and 3B disclose an outer surface of the balloon with a radius of curvature and the polymeric pad closely conforming to the curvature of the outer surface of the balloon. However, Gunderson fails to explicitly disclose that the outer surface of the balloon has a radius of curvature in a range of 1 millimeter to 4 millimeters and the mounting surface has a pad radius of curvature in a range of 1 millimeter to 10 millimeters.
Gunderson discloses the general conditions of the claim, in that the balloon has an outer surface with a radius of curvature and the mounting surface as a pad radius of curvature to provide a balloon with cutting members that more closely conform to the expansion characteristics of the balloon. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer surface of the balloon to have a radius of curvature in a range of 1 millimeter to 4 millimeters and the mounting surface to have a pad radius of curvature in a range of 1 millimeter to 10 millimeters as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine optimization.” In re Aller, 22 F.2d 454, 456, 105 USPQ 233, 235 (CCPA).
Regarding claim 9, Gunderson teaches an adhesive layer disposed between the outer surface of the inflatable balloon and the mounting surface of the polymeric pad (paragraph 0044).
Regarding claim 17, Gunderson discloses (Figure 1-12) a medical device, comprising: an inflatable balloon (16) secured to a distal region of a catheter shaft (24, 26) having a longitudinal axis, the inflatable balloon having an outer surface with, when inflated, a balloon radius of curvature; a polymeric pad (38) having a mounting surface adapted to be secured to the inflatable balloon (paragraphs 0044-0046), the mounting surface having a pad radius of curvature (Figures 3A and 3B); an adhesive layer securing the polymeric pad to the outer surface of the inflatable balloon (paragraph 0044); and a blade member (20) embedded within the polymeric pad (paragraphs 0044-0046), the blade member including two or more blade segments separated by one or more blade flex points (Figures 4-12 depict blade segments with flex points and as claimed); the polymeric pad comprising one or more pad flex points aligned with the one or more blade flex points (paragraphs 0049, 0052, 0058, 0059, 0066, 0072, 0076, 0079). Figures 3A and 3B disclose an outer surface of the balloon with a radius of curvature and the polymeric pad closely conforming to the curvature of the outer surface of the balloon. However, Gunderson fails to explicitly disclose that the outer surface of the balloon has a radius of curvature in a range of 1 millimeter to 4 millimeters and the mounting surface has a pad radius of curvature in a range of 1 millimeter to 10 millimeters.
Gunderson discloses the general conditions of the claim, in that the balloon has an outer surface with a radius of curvature and the mounting surface as a pad radius of curvature to provide a balloon with cutting members that more closely conform to the expansion characteristics of the balloon. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the outer surface of the balloon to have a radius of curvature in a range of 1 millimeter to 4 millimeters and the mounting surface to have a pad radius of curvature in a range of 1 millimeter to 10 millimeters as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine optimization.” In re Aller, 22 F.2d 454, 456, 105 USPQ 233, 235 (CCPA).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2016/0081711 A1) (“Gunderson”) in view of Giasolli et al. (US 2022/0211983 A1) (“Giasolli”).
Regarding claim 18, Gunderson discloses the invention substantially as claimed. However, Gunderson fails to explicitly disclose that the adhesive layer has a uniform thickness.
In the same field of endeavor, Giasolli teaches (Figure 34) that it is known in the art to apply adhesive layers with uniform thickness when assembling a balloon catheter (paragraphs 0244-0259).
It would have been obvious to one having skill in the art before the effective filing date of the claimed invention to modify the adhesive layer to have a uniform thickness, as taught by Giasolli. This modification would apply longitudinal dispersion of adhesive to attach the polymeric pad longitudinally to the balloon (Giasolli, paragraphs 0244-0259).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Gunderson et al. (US 2016/0081711 A1) (“Gunderson”) in view of Manderfeld et al. (US 2012/0172901 A1) (“Manderfeld”).
Regarding claim 19, Gunderson teaches the invention substantially as claimed. However, Gunderson fails to disclose the polymeric pad further comprises a tapered surface opposite the mounting surface.
In the same field of endeavor, Manderfeld teaches (Figure 3) a polymeric pad (40) having a mounting surface (54) adapted to be secured to the inflatable balloon. Manderfeld teaches the polymeric pad further comprises a tapered surface (engaging first side surface 52 and second side surface 53 of the cutting member),
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the polymeric pad taught by Gunderson to comprise a tapered surface opposite the mounting surface, as taught by Manderfeld. This modification would result in increased embedded engagement between the first and second side surfaces of the cutting member and the polymeric base pad, which would provide further mechanical interlock between the cutting member and the polymeric pad, resulting in a more secure attachment between the cutting member and the balloon (Manderfeld, paragraph 0045).
Response to Arguments
Applicant's arguments filed 6/15/26 have been fully considered but they are not persuasive.
Regarding the rejections under 35 U.S.C § 102, the Applicant has argued that the Gunderson reference fails to discuss separate pad flex structures (i.e., pad flex points). The Applicant argues that the mounting pad 38 of Gunderson is disclosed as a structure that encases/embeds the blade base to secure the blade to the balloon. The Applicant argues that the claim requires blade flex points in the blade member and separate pad flex points in the polymeric pad and anticipation requires disclosure of the claimed polymeric pad comprising pad flex points, not merely a pad that deforms because a different embedded component flexes. The Examiner respectfully disagrees with these arguments.
Claim 1 requires a polymeric pad comprising a first pad flex point and a second pad flex point (Claim 11 recites “comprising one or more pad flex points…”). The claim is broader than how the Applicant has argued the rejections. There is no requirement in any of the independent claims that a “flex point” is a separate structure from the rest of the pad. A point is defined as “a location, spot, or position” (Dictionary.com definition). Claim 1 requires a polymeric pad comprising a first flex location/spot/position aligned the first blade flex point and a second flex location/spot/position aligned with the second blade flex point. Gunderson discloses that the purpose of the invention is to improve cutting elements, such as cutting blades, and methods of mounting cutting elements onto an inflatable angioplasty balloon of an angioplasty balloon catheter which enhance the flexibility of the construct (paragraph 0006), i.e., both the structure of the cutting elements and the method of mounting the cutting elements to the balloons (polymeric adhesive material, paragraph 0044) result in an angioplasty balloon with enhanced flexibility. Further, Gunderson discloses a resulting balloon that is more flexible for navigating tortuous anatomy (paragraph 0081). Gunderson discloses various blade structures with discrete regions of enhanced flexibility (375, 475, 575, 675, 775, 875). Regions of the polymeric pad are aligned with the discrete regions of enhanced flexibility, to both secure the blade to the balloon and allow the cutting members to closely conform to the expansion characteristics of the balloon without fracturing under normal usage. The features of the polymeric pad are broadly recited, and the Examiner maintains the Gunderson reference anticipates claims 1, 2, 7, 10-12, and 15 as currently written.
Regarding the rejections under 35 U.S.C § 103, the Applicant has argued that the Office Action’s characterization of the expandable frame 208 of Haverkost as polymeric is factually unsupported and is inconsistent with the disclosure of Haverkost. The Applicant cites paragraphs 0133-0134 of Haverkost, which disclose the frame is metallic. The Examiner respectfully disagrees with these arguments.
Paragraphs 0133-0134 of Haverkost do disclose that metallic material is one of the materials that the expandable frame can be made of. However, paragraph 0133 discloses that other materials may be used, as desired. In paragraph 0162, Haverkost discloses the catheter 10, the balloon 16, the expandable frame 36, the expandable frame 100, the expandable frame 208, the expandable frame 300, and/or components thereof, etc., and/or portions thereof, may be made from or include a polymer or other suitable material. Thus, the Office Action’s characterization of the expandable frame as polymeric is factually supported and consistent with the disclosure of Haverkost.
For these reasons, the Examiner maintains that the claims as currently written do not distinguish over the prior art of record.
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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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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