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
The amendments to claims 1, 14, and 20 filed 04/22/2026 are acknowledged and the previous claim objections are withdrawn.
The amendments to claims 1, 14, and 20 filed 04/22/2026 are acknowledged and the previous 112(b) rejections are withdrawn.
Response to Arguments
Applicant's arguments filed 04/22/2026 have been fully considered but they are not persuasive.
Applicant argues that Ewers fails to teach or suggest “wherein the plurality of longitudinal tines are between the inner funnel surface and the outer funnel surface” as required in claim 1. Applicant explains that Ewers rather teaches a mesh umbrella being laid over or attached to the upper surfaces of a strutted anchor and because the ends (130 and 132) of the mesh sleeve 120 in Ewers et al. are fused to form a fused end 122, this would seem to prevent the positioning of any tines within the inverted sleeve of Ewers.
The examiner respectfully disagrees. In response to applicant's argument that the mesh umbrella of Ewers being laid over and fused to form a fused end 122 would prevent the positioning of any tines within the inverted sleeve of Ewers, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In this case, it is the examiner’s position that Ewers does teach a mesh 128 inverted over itself to form an expandable funnel such that a first portion of the mesh forms an inner funnel surface and a second portion of the mesh forms an outer funnel surface. Para. 0065 of Ewers describes the formation of the expandable funnel 128 in Fig. 9C, stating “The sleeve is inverted, and the second end 132 is fed back through the sleeve until it is located radially inward of the first end 130. Therefore, para. 0070 of Ewers further stating that “a mesh umbrella 128 (such as those described above in relation to FIGS. 8B, 9C, and 11B) is laid over …the upper surfaces of a strutted anchor 50” supports that the mesh shown in Fig. 13 is inverted over a plurality of longitudinal tines of the strutted anchor such that the second end of the mesh is fed through the sleeve to lay over the upper surface of the longitudinal tines of the strutted anchor until it is located radially inward of the first end. This results in the plurality of longitudinal tines being between the inner funnel surface and the outer funnel surface as claimed.
Applicant argues that Ewers et al. relates to a tissue anchor, and does not appear to relate to a funnel at a distal end of an elongate body of an inversion support. Applicants respectfully submit that one of ordinary skill in the art would not be motivated to look to the tissue anchors of Ewers to modify the funnel of Wallace.
The examiner respectfully disagrees. In response to applicant's argument that the device of Ewers is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Ewers is in the same field of endeavor of expandable funnels such that both Wallace and Ewers include funnel shaped structures comprising a plurality of longitudinal tines used to support the expansion of the funnel (para. 0070 of Ewers). As stated in the prior art rejection, Ewers teaches that it is advantageous for an expandable funnel with longitudinal tines to have a mesh inverted over the longitudinal tines to protect the ends of the tines from direct abrasion (para. 0065: “the tissue anchor 50 embodiment includes a transition line 86 that is non-fraying because it is formed of a continuous layer of mesh that has been doubled over” which is desired by Wallace’s (para. 0220: “As the large clot 4413 is brought into the distal end opening, the distal end opening may expand and open along the slots or slits 4403, as shown in FIG. 44C, so that the distal end opening flares out. In some variations an elastic sleeve, gasket, ring or cover (not shown in FIG. 44A-44C) may be included at least partially covering the distal end to prevent the edge from catching the tractor”). Therefore, the rejection is maintained.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 8-9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace (US 20170303948) in view of Ewers et al. (US 20080009888) [hereinafter Ewers], Graber (US 5190561), and Gartner et al. (US 20070027456) [hereinafter Gartner].
Note: The examiner notes that the embodiment of the inversion catheter system shown in Figs. 44A-C is relied upon in the rejection. However, the embodiment of Figs. 1A-H are relied upon to refer to shared elements that are not shown in Figs. 44A-C.
Regarding claim 1, Wallace discloses a system (Figs. 44A-C, para. 0220), the system comprising:
an inversion support catheter (not labeled, but discussed in para. 0220) having an elongate body (see catheter 100 of Fig. 1A for example, para. 0120), the inversion support catheter having an expandable funnel (interpreted as expandable distal end 4401) at a distal end of the elongate body, (Fig. 44A-C, para. 0220) the expandable funnel including a plurality of longitudinal tines (interpreted as the arms formed by slots/slits 4403; para. 0221 further discloses that the distal end “may be configured with strands or rods extending in the proximal-to-distal axis that have a high compressive load strength, but which may separate from each other to enlarge the distal end opening”) extending from the distal end of the elongate body (Figs. 44A-C, para. 0220-0221);
a flexible tube 140 (best shown in Fig. 1C, para. 0123, 0220) having a first end region (see annotated Fig. 44B below) within the inversion support catheter (Figs. 1E-F, para. 0123-0126) and a second end region (see annotated Fig. 44B below, para. 0126) extending over an outer surface of the elongate body (Fig. 1E-F, 44A-C, para. 0123-0126, 0220), wherein the flexible tube inverts over the distal end of the expandable funnel (Figs. 44A-C, para. 0220), further wherein the flexible tube is configured to be pulled proximally into the inversion support catheter by pulling the first end region proximally so that the second end region rolls and inverts over the distal end of the expandable funnel as it is pulled into the inversion support catheter (Figs. 44A-C, para. 0126, 0220).
However, Wallace fails to disclose wherein the expandable funnel comprises a mesh inverted over itself at the distal end of the expandable funnel such that a first portion of the mesh forms an inner funnel surface and a second portion of the mesh forms an outer funnel surface, and wherein the plurality of longitudinal tines are between the inner funnel surface and the outer funnel surface.
Ewers in the same field of endeavor teaches an expandable funnel 150 (Fig. 13, para. 0070) comprising a mesh 128 inverted over itself at a distal end of the funnel (para. 0070 states “a mesh umbrella 128 (such as those described above in relation to FIGS. 8B, 9C, and 11B) is laid over or attached to the upper surfaces of a strutted anchor 50 (such as those described above in relation to any of FIGS. 3C-D, 4A-B, 5A-B, and/or 6C)”. Figs. 9A-C, para. 0065 illustrate and describe a mesh inverted over itself at a distal end of the funnel) such that a first portion of the mesh forms an inner funnel surface (interpreted as portion defined by second end 132 that is fed through the mesh sleeve to form the inner funnel surface, Figs. 9A-C, para. 0065) and a second portion of the mesh forms an outer funnel surface (interpreted as portion defined by first end 130 that is located radially outward from the second end 132, forming the outer funnel surface, Figs. 9A-C, para. 0065), wherein a plurality of longitudinal tines 90 (Figs. 3C, 13, para. 0056, 0070) are between the inner funnel surface and the outer funnel surface (para. 0065, 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the expandable funnel in Wallace to include the mesh of Ewers in order to protect the ends of the longitudinal tines from direct abrasion from use (para. 0065 of Ewers) and provide additional surface contact with the flexible tube (para. 0070 of Ewers), thereby improving the efficiency of the device during use.
Modified Wallace further discloses that the longitudinal tines may be connected by a distal ring, thereby the distal ring extends through and connects distal end regions of each of the plurality of longitudinal tines in order to provide elastic support (para. 0021 of Wallace). However, modified Wallace fails to disclose a suture threaded through.
Graber in the same field of endeavor teaches a catheter 26 having an elongated body 66 and comprising an expandable funnel 28 used for capturing tissue (Figs. 5-6, col. 5 lines 4-14), the expandable funnel 28 including a plurality of longitudinal tines 74, 76, 78, 80 extending from a distal end of the elongate body 66 (Figs. 1-2, col. 4 lines 24-27), and a distal ring (interpreted as cable 82) radially connecting the plurality of longitudinal tines (Figs. 1-2, col. 4 lines 24-27 and 45-46). The reference teaches that it is known in the art to have the plurality of longitudinal tines comprise eye ends 86, 88, 90, 92 to define distal ends of the plurality of longitudinal tines and hold the suture (Fig. 2, col. 4 lines 24-27 and 45-46).
Gartner in the same field of endeavor teaches that it is known in the art that suture material is a known flexible material used to thread through a distal end of a plurality of longitudinal tines 140 to form a loop (Figs. 13-14, para. 0047).
In light of these teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal ends of the longitudinal tines in modified Wallace to include the eye ends of Graber and the modify the distal ring in Wallace to include the suture material of Gartner in order to assist in distributing the forces applied to the longitudinal tines during expansion, as taught by Gartner (para. 0049 of Gartner).
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Annotated Fig. 44B of Wallace
Regarding claim 2, modified Wallace discloses wherein the plurality of longitudinal tines include distal ends (see Figs. 44A-C, para. 0220-0221 of Wallace), and the suture radially connects the plurality of longitudinal tines at or adjacent the distal ends of the plurality of longitudinal tines (Fig. 2, col. 4 lines 24-27 and 45-46 of Graber).
Regarding claim 8, modified Wallace discloses wherein the expandable funnel 4401 has a collapsed configuration and an expanded configuration (Figs. 44A-C, para. 0220-0221 of Wallace).
Regarding claim 9, modified Wallace discloses further including a puller 146 within a lumen of the inversion support catheter (Figs. 1E-F, para. 0126, 0220 of Wallace), and the first end region of the flexible tube is attached to the puller within the inversion support catheter (see annotated Fig. 44B above, para. 0126 of Wallace), wherein the flexible tube is configured to be pulled proximally into the inversion support catheter by pulling the puller proximally (para. 0126, 0220 of Wallace).
Regarding claim 11, modified Wallace discloses wherein the plurality of longitudinal tines are continuous with the elongate body (see Figs. 44A-C of Wallace which illustrates the proximal ends of longitudinal tines being continuous with the elongated body, para. 0220-0221 of Wallace).
Regarding claim 12, modified Wallace discloses wherein the elongate body is a metallic hypotube (para. 0013 of Wallace) that includes cuts to define the plurality of longitudinal tines (Figs. 44A-C, para. 0220-0221 of Wallace).
Regarding claim 13, modified Wallace discloses wherein the flexible tube is knitted (para. 0015 of Wallace).
Claim(s) 3-7, 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over Wallace (US 20170303948) in view of Ewers et al. (US 20080009888) [hereinafter Ewers], Graber (US 5190561), and Gartner et al. (US 20070027456) [hereinafter Gartner] as applied to claim 1 above, and further in view of Avneri et al. (US 20140296889) [hereinafter Avneri].
Regarding claim 3, modified Wallace discloses all of the limitation set forth above in claim 1. Modified Wallace discloses wherein the plurality of longitudinal tines include distal ends (see Figs. 44A-C, para. 0220-0221 of Wallace). However, modified Wallace fails to disclose wherein the plurality of longitudinal tines are folded back on themselves to define the distal ends, and each incudes a main tine portion and a folded back portion on each of the plurality of longitudinal tines.
Avneri, in the same field of endeavor, teaches a dissection tool 180 having an elongated body (shown in Fig. 18B) and comprising an expandable funnel 181 used for capturing plaque 12 (Fig. 18B, best described in para. 0133), the expandable funnel 181 including a plurality of longitudinal tines 183 (Note: having eye ends (interpreted as folded and rolled, distal ends of the longitudinal tines 183 having a central opening, see Fig. 18A). This reference teaches that it is known in the art to form eye ends by folding the tines back on themselves to define the distal ends (Figs. 18A-C, para. 0133-0134), and each incudes a main tine portion and a folded back portion on each of the plurality of longitudinal tines (see annotate Fig. 18C of Avneri below).
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The substitution of one known eye end (folded/rolled eye end as shown in Avneri) for another (eye end as shown in modified Wallace) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the folded/rolled eye ends shown in Avneri would have yielded predictable results, namely, an alternative way to hold and retain the suture (Figs. 18A-C, para. 0133-0134 of Avneri). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
Regarding claim 4, modified Wallace discloses wherein the distal ends of the plurality of longitudinal tines are blunted or rounded (Fig. 18A of Avneri).
Regarding claim 5, The combination of modified Wallace in view of Avneri discloses wherein the suture radially connecting the plurality of longitudinal tines of Wallace (para. 0221 of Wallace) extends between the main tine portion and the folded back portion on each of the plurality of longitudinal tines as taught by Graber and Avneri (Graber teaches that the suture is retained within an eye end of the longitudinal tines, Fig. 2, col. 4 lines 24-27 and 45-46 of Graber; Avneri teaches that an eye end can be formed from folding the distal end such that the suture is capable of extending between the main tine portion and the folded back portion, Fig. 18A and annotated Fig. 18C of Avneri, para. 0132-0133).
Regarding claim 6, The combination of modified Wallace in view of Avneri discloses wherein the suture radially connecting the plurality of longitudinal tines of Wallace (para. 0221 of Wallace) is crimped between the main tine portion and the folded back portion on each of the plurality of longitudinal tines as taught by Graber and Avneri (Graber teaches that the suture is retained within an eye end of the longitudinal tines, Fig. 2, col. 4 lines 24-27 and 45-46 of Graber; Avneri teaches that an eye end can be formed from folding the distal end such that the suture is capable of being crimped between the main tine portion and the folded back portion, Fig. 18A and annotated Fig. 18C of Avneri, para. 0132-0133).
Regarding claim 7, modified Wallace discloses all of the limitation set forth above in claim 1. However, modified Wallace fails to disclose wherein the plurality of longitudinal tines include portions that are folded back on themselves to define a main tine portion and a folded back portion on each of the plurality of longitudinal tines, and the suture radially connecting the plurality of longitudinal tines extends between the main tine portion and the folded back portion on each of the plurality of longitudinal tines.
Avneri, in the same field of endeavor, teaches a dissection tool 180 having an elongated body (shown in Fig. 18B) and comprising an expandable funnel 181 used for capturing plaque 12 (Fig. 18B, best described in para. 0133), the expandable funnel 181 including a plurality of longitudinal tines 183 (Note: having eye ends (interpreted as folded and rolled, distal ends of the longitudinal tines 183 having a central opening, see Fig. 18A). This reference teaches that it is known in the art to form eye ends by folding portions of the tines back on themselves (Figs. 18A-C, para. 0133-0134) to define a main tine portion and a folded back portion on each of the plurality of longitudinal tines (Fig. 18A, see annotated Fig. 18C above, para. 0133-0134).
The substitution of one known eye end (folded/rolled eye end as shown in Avneri) for another (eye end as shown in modified Wallace) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the folded/rolled eye ends shown in Avneri would have yielded predictable results, namely, an alternative way to hold and retain the suture (Figs. 18A-C, para. 0133-0134 of Avneri). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
The combination of modified Wallace in view of Avneri discloses wherein the suture radially connecting the plurality of longitudinal tines of Wallace (para. 0221 of Wallace) extends between the main tine portion and the folded back portion on each of the plurality of longitudinal tines as taught by Graber and Avneri (Graber teaches that the suture is retained within an eye end of the longitudinal tines, Fig. 2, col. 4 lines 24-27 and 45-46 of Graber; Avneri teaches that an eye end can be formed from folding the distal end such that the suture is capable of extending between the main tine portion and the folded back portion, Fig. 18A and annotated Fig. 18C of Avneri, para. 0132-0133).
Regarding claim 14, Wallace discloses a system (Figs. 44A-C, para. 0220), the system comprising:
an inversion support catheter (not labeled, but discussed in para. 0220) having an elongate body (see catheter 100 of Fig. 1A for example, para. 0120), the inversion support catheter having an expandable funnel (interpreted as expandable distal end 4401) at a distal end of the elongate body, (Fig. 44A-C, para. 0220) the expandable funnel including a plurality of longitudinal tines (interpreted as the arms formed by slots/slits 4403; para. 0221 further discloses that the distal end “may be configured with strands or rods extending in the proximal-to-distal axis that have a high compressive load strength, but which may separate from each other to enlarge the distal end opening”) extending from the distal end of the elongate body (Figs. 44A-C, para. 0220-0221); and
a flexible tube 140 (best shown in Fig. 1C, para. 0123, 0220) having a first end region (see annotated Fig. 44B above) within the inversion support catheter (Figs. 1E-F, para. 0123-0126) and a second end region (see annotated Fig. 44B above, para. 0126) extending over an outer surface of the elongate body (Fig. 1E-F, 44A-C, para. 0123-0126, 0220), wherein the flexible tube inverts over the distal end of the expandable funnel (Figs. 44A-C, para. 0220), further wherein the flexible tube inverts over a distal end of the expandable funnel (Figs. 44A-C, para. 0126, 0220).
However, Wallace fails to disclose wherein the expandable funnel comprises a mesh inverted over itself at a distal end of the expandable funnel such that a first portion of the mesh forms an inner funnel surface and a second portion of the mesh forms an outer funnel surface, and wherein the plurality of longitudinal tines are between the inner funnel surface and the outer funnel surface.
Ewers in the same field of endeavor teaches an expandable funnel 150 (Fig. 13, para. 0070) comprising a mesh 128 inverted over itself at a distal end of the funnel (para. 0070 states “a mesh umbrella 128 (such as those described above in relation to FIGS. 8B, 9C, and 11B) is laid over or attached to the upper surfaces of a strutted anchor 50 (such as those described above in relation to any of FIGS. 3C-D, 4A-B, 5A-B, and/or 6C)”. Figs. 9A-C, para. 0065 illustrate and describe a mesh inverted over itself at a distal end of the funnel) such that a first portion of the mesh forms an inner funnel surface (interpreted as portion defined by second end 132 that is fed through the mesh sleeve to form the inner funnel surface, Figs. 9A-C, para. 0065) and a second portion of the mesh forms an outer funnel surface (interpreted as portion defined by first end 130 that is located radially outward from the second end 132, forming the outer funnel surface, Figs. 9A-C, para. 0065), wherein a plurality of longitudinal tines 90 (Figs. 3C, 13, para. 0056, 0070) are between the inner funnel surface and the outer funnel surface (para. 0065, 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the expandable funnel in Wallace to include the mesh of Ewers in order to protect the ends of the longitudinal tines from direct abrasion from use (para. 0065 of Ewers) and provide additional surface contact with the flexible tube (para. 0070 of Ewers), thereby improving the efficiency of the device during use.
Modified Wallace further discloses that the longitudinal tines may be connected by a distal ring, thereby the distal ring extends through and connects distal end regions of each of the plurality of longitudinal tines in order to provide elastic support (para. 0021 of Wallace). However, modified Wallace fails to disclose a suture threaded through.
Graber in the same field of endeavor teaches a catheter 26 having an elongated body 66 and comprising an expandable funnel 28 used for capturing tissue (Figs. 5-6, col. 5 lines 4-14), the expandable funnel 28 including a plurality of longitudinal tines 74, 76, 78, 80 extending from a distal end of the elongate body 66 (Figs. 1-2, col. 4 lines 24-27), and a distal ring (interpreted as cable 82) radially connecting the plurality of longitudinal tines (Figs. 1-2, col. 4 lines 24-27 and 45-46). The reference teaches that it is known in the art to have the plurality of longitudinal tines comprise eye ends 86, 88, 90, 92 to define distal ends of the plurality of longitudinal tines and hold the suture (Fig. 2, col. 4 lines 24-27 and 45-46).
Gartner in the same field of endeavor teaches that it is known in the art that suture material is a known flexible material used to thread through a distal end of a plurality of longitudinal tines 140 to form a loop (Figs. 13-14, para. 0047).
In light of these teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal ends of the longitudinal tines in modified Wallace to include the eye ends of Graber and the modify the distal ring in Wallace to include the suture material of Gartner in order to assist in distributing the forces applied to the longitudinal tines during expansion, as taught by Gartner (para. 0049 of Gartner).
However, modified Wallace fails to disclose wherein the plurality of longitudinal tines include portions that are folded back on themselves to define a main tine portion and a folded back portion on each of the plurality of longitudinal tines, and the suture threaded with each of the plurality of longitudinal tines that extends between the main tine portion and the folded back portion on each of the plurality of longitudinal tines.
Avneri, in the same field of endeavor, teaches a dissection tool 180 having an elongated body (shown in Fig. 18B) and comprising an expandable funnel 181 used for capturing plaque 12 (Fig. 18B, best described in para. 0133), the expandable funnel 181 including a plurality of longitudinal tines 183 (Note: having eye ends (interpreted as folded and rolled, distal ends of the longitudinal tines 183 having a central opening, see Fig. 18A). This reference teaches that it is known in the art to form eye ends by folding portions of the tines back on themselves (Figs. 18A-C, para. 0133-0134) to define a main tine portion and a folded back portion on each of the plurality of longitudinal tines (Fig. 18A, see annotated Fig. 18C above, para. 0133-0134).
The substitution of one known eye end (folded/rolled eye end as shown in Averni) for another (eye end as shown in modified Wallace) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the folded/rolled eye ends shown in Averni would have yielded predictable results, namely, an alternative way to hold and retain the suture (Figs. 18A-C, para. 0133-0134 of Averni). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
The combination of modified Wallace in view Avneri discloses wherein the suture of Gartner (Figs. 13-14, para. 0047 of Gartner) threaded with each of the plurality of longitudinal tines of Wallace (para. 0221 of Wallace) extends between the main tine portion and the folded back portion on each of the plurality of longitudinal tines as taught by Graber and Avneri (Graber teaches that the suture is retained within an eye end of the longitudinal tines, Fig. 2, col. 4 lines 24-27 and 45-46 of Graber; Avneri teaches that an eye end can be formed from folding the distal end such that the suture is capable of extending between the main tine portion and the folded back portion, Fig. 18A and annotated Fig. 18C of Avneri, para. 0132-0133).
Regarding claim 15, The combination of Wallace in view of Ewers, Graber, Avneri, and Gartner discloses wherein the suture radially connecting the plurality of longitudinal tines of Wallace (para. 0221 of Wallace) is crimped between the main tine portion and the folded back portion on each of the plurality of longitudinal tines as taught by Graber and Avneri (Graber teaches that the suture is retained within an eye end of the longitudinal tines, Fig. 2, col. 4 lines 24-27 and 45-46 of Graber; Avneri teaches that an eye end can be formed from folding the distal end such that the suture is capable of being crimped between the main tine portion and the folded back portion, Fig. 18A and annotated Fig. 18C of Avneri, para. 0132-0133).
Regarding claim 16, modified Wallace discloses a puller 146 within a lumen of the inversion support catheter (Figs. 1E-F, para. 0126, 0220 of Wallace), and the first end region of the flexible tube is attached to the puller within the inversion support catheter (see annotated Fig. 44B above, para. 0126 of Wallace), wherein the flexible tube is configured to be pulled proximally into the inversion support catheter by pulling the puller proximally (para. 0126, 0220 of Wallace).
Regarding claim 17, modified Wallace discloses wherein the plurality of longitudinal tines are continuous with the elongate body (see Figs. 44A-C of Wallace which illustrates the proximal ends of longitudinal tines being continuous with the elongated body, para. 0220-0221 of Wallace).
Regarding claim 18, modified Wallace discloses wherein the elongate body is a metallic hypotube (para. 0013 of Wallace) that includes cuts to define the plurality of longitudinal tines (Figs. 44A-C, para. 0220-0221 of Wallace).
Regarding claim 19, modified Wallace discloses wherein the plurality of longitudinal tines each define distal ends that are blunted or rounded (Fig. 18A of Avneri).
Regarding claim 20, Wallace an inversion support catheter (not labeled, but discussed in para. 0220) having an elongate body (see catheter 100 of Fig. 1A for example, para. 0120), the inversion support catheter having an expandable funnel (interpreted as expandable distal end 4401) at a distal end of the elongate body, (Fig. 44A-C, para. 0220) the expandable funnel including a plurality of longitudinal tines (interpreted as the arms formed by slots/slits 4403; para. 0221 further discloses that the distal end “may be configured with strands or rods extending in the proximal-to-distal axis that have a high compressive load strength, but which may separate from each other to enlarge the distal end opening”) extending from the distal end of the elongate body (Figs. 44A-C, para. 0220-0221); and
a flexible tube 140 (best shown in Fig. 1C, para. 0123, 0220) having a first end region (see annotated Fig. 44B above) within the inversion support catheter (Figs. 1E-F, para. 0123-0126) and a second end region (see annotated Fig. 44B above, para. 0126) extending over an outer surface of the elongate body (Fig. 1E-F, 44A-C, para. 0123-0126, 0220), wherein the flexible tube inverts over a distal end of the expandable funnel (Figs. 44A-C, para. 0220), further wherein the flexible tube is configured to be pulled proximally into the inversion support catheter by pulling the first end region proximally so that the second end region rolls and inverts over the distal end of the expandable funnel as it is pulled into the inversion support catheter (Figs. 44A-C, para. 0126, 0220);
a puller 146 within a lumen of the inversion support catheter (Figs. 1E-F, para. 0126, 0220), and the first end region of the flexible tube is attached to the puller within the inversion support catheter (see annotated Fig. 44B above, para. 0126), wherein the flexible tube is configured to be pulled proximally into the inversion support catheter by pulling the puller proximally (para. 0126, 0220).
However, Wallace fails to disclose wherein the expandable funnel comprises a mesh inverted over itself at a distal end of the expandable funnel such that a first portion of the mesh forms an inner funnel surface and a second portion of the mesh forms an outer funnel surface, and wherein the plurality of longitudinal tines are between the inner funnel surface and the outer funnel surface.
Ewers in the same field of endeavor teaches an expandable funnel 150 (Fig. 13, para. 0070) comprising a mesh 128 inverted over itself at a distal end of the funnel (para. 0070 states “a mesh umbrella 128 (such as those described above in relation to FIGS. 8B, 9C, and 11B) is laid over or attached to the upper surfaces of a strutted anchor 50 (such as those described above in relation to any of FIGS. 3C-D, 4A-B, 5A-B, and/or 6C)”. Figs. 9A-C, para. 0065 illustrate and describe a mesh inverted over itself at a distal end of the funnel) such that a first portion of the mesh forms an inner funnel surface (interpreted as portion defined by second end 132 that is fed through the mesh sleeve to form the inner funnel surface, Figs. 9A-C, para. 0065) and a second portion of the mesh forms an outer funnel surface (interpreted as portion defined by first end 130 that is located radially outward from the second end 132, forming the outer funnel surface, Figs. 9A-C, para. 0065), wherein a plurality of longitudinal tines 90 (Figs. 3C, 13, para. 0056, 0070) are between the inner funnel surface and the outer funnel surface (para. 0065, 0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the expandable funnel in Wallace to include the mesh of Ewers in order to protect the ends of the longitudinal tines from direct abrasion from use (para. 0065 of Ewers) and provide additional surface contact with the flexible tube (para. 0070 of Ewers), thereby improving the efficiency of the device during use.
Modified Wallace further discloses that the longitudinal tines may be connected by a distal ring, thereby the distal ring extends through and connects distal end regions of each of the plurality of longitudinal tines in order to provide elastic support (para. 0021 of Wallace). However, modified Wallace fails to disclose a suture threaded through.
Graber in the same field of endeavor teaches a catheter 26 having an elongated body 66 and comprising an expandable funnel 28 used for capturing tissue (Figs. 5-6, col. 5 lines 4-14), the expandable funnel 28 including a plurality of longitudinal tines 74, 76, 78, 80 extending from a distal end of the elongate body 66 (Figs. 1-2, col. 4 lines 24-27), and a distal ring (interpreted as cable 82) radially connecting the plurality of longitudinal tines (Figs. 1-2, col. 4 lines 24-27 and 45-46). The reference teaches that it is known in the art to have the plurality of longitudinal tines comprise eye ends 86, 88, 90, 92 to define distal ends of the plurality of longitudinal tines and hold the suture (Fig. 2, col. 4 lines 24-27 and 45-46).
Gartner in the same field of endeavor teaches that it is known in the art that suture material is a known flexible material used to thread through a distal end of a plurality of longitudinal tines 140 to form a loop (Figs. 13-14, para. 0047).
In light of these teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal ends of the longitudinal tines in Wallace to include the eye ends of Graber and the modify the distal ring in modified Wallace to include the suture material of Gartner in order to assist in distributing the forces applied to the longitudinal tines during expansion, as taught by Gartner (para. 0049 of Gartner). However, modified Wallace fails to disclose each of the plurality of longitudinal tines including portions that are folded back on themselves to define a main tine portion and a folded back portion, and the suture threaded with and radially connecting the plurality of longitudinal tines and extending between the main tine portion and the folded back portion on each of the plurality of longitudinal tines.
Avneri, in the same field of endeavor, teaches a dissection tool 180 having an elongated body (shown in Fig. 18B) and comprising an expandable funnel 181 used for capturing plaque 12 (Fig. 18B, best described in para. 0133), the expandable funnel 181 including a plurality of longitudinal tines 183 (Note: having eye ends (interpreted as folded and rolled, distal ends of the longitudinal tines 183 having a central opening, see Fig. 18A). This reference teaches that it is known in the art to form eye ends by folding portions of the tines back on themselves (Figs. 18A-C, para. 0133-0134) to define a main tine portion and a folded back portion on each of the plurality of longitudinal tines (Fig. 18A, see annotated Fig. 18C above, para. 0133-0134).
The substitution of one known eye end (folded/rolled eye end as shown in Averni) for another (eye end as shown in modified Wallace) would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention since the substitution of the folded/rolled eye ends shown in Averni would have yielded predictable results, namely, an alternative way to hold and retain the suture (Figs. 18A-C, para. 0133-0134 of Averni). KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007)
The combination of Wallace in view of Ewers, Graber, Gartner, and Avneri discloses wherein the suture of Gartner (Figs. 13-14, para. 0047 of Gartner) threaded with and radially connecting the plurality of longitudinal tines of Wallace (para. 0221 of Wallace) and extending between the main tine portion and the folded back portion on each of the plurality of longitudinal tines as taught by Graber and Avneri (Graber teaches that the suture is retained within an eye end of the longitudinal tines, Fig. 2, col. 4 lines 24-27 and 45-46 of Graber; Avneri teaches that an eye end can be formed from folding the distal end such that the suture is capable of extending between the main tine portion and the folded back portion, Fig. 18A and annotated Fig. 18C of Avneri, para. 0132-0133).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Wallace (US 20170303948) in view of Ewers et al. (US 20080009888) [hereinafter Ewers], Graber (US 5190561), and Gartner et al. (US 20070027456) [hereinafter Gartner]as applied to claim 1 above, and further in view of Adams (US 20070213765).
Regarding claim 10, modified Wallace discloses all of the limitations set forth above in claim 1. However, modified Wallace fails to disclose wherein a base region of the expandable funnel adjacent to the distal end of the elongate body is porous.
Adams in the same field of endeavor teaches a thrombectomy device comprising an expandable funnel 50a (Fig. 5A, para. 0071), wherein a base region of the expandable funnel adjacent to a distal end of an elongated body is porous via. openings 56a (Fig. 5A, para. 0071).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to modify the base region of the expandable funnel in Wallace to include the plurality of openings of Adams in order to allow fluid flow during the procedure, thereby preventing any back up of fluid flow (para. 0071 of Adams).
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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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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