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 present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Regarding the previous claim objection, the amendment to claim 1 is acknowledged and the claim objection is withdrawn.
Regarding the previous 112(b) rejection, the amendments to claims 1, 14, and 20 are acknowledged and the 112(b) rejections are withdrawn.
Applicant’s arguments, see page 2, filed 03/06/2025, with respect to the rejection(s) of claim(s) 1, 14, and 20 under Wallace and Wallace in view of Graber and Avneri have been fully considered and are persuasive. The examiner agrees that Wallace nor Graber and Avneri disclose or suggest “a suture threaded through”. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Wallace in view of Graber and Gartner et al. (US 20070027456) [hereinafter Gartner] for claim 1 and Wallace in view of Graber, Avneri, and Gartner et al. (US 20070027456) [hereinafter Gartner] for claims 14 and 20.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 5-7, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 2, 5-7, and 15, recite the limitation "the filament". There is insufficient antecedent basis for this limitation in the claim. Para. 0047 of the specification of the instant application describes the suture, as recited in claims 1 and 14, as the filament. For examination purposes, “the filament” is interpreted as “the suture” as recited in claims 1 and 14.
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 Gartner et al. (US 20070027456) [hereinafter Gartner] and Graber (US 5190561).
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); and
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 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).
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). However, 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 filament (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 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 filament (interpreted as the suture of claim 1, see 112(b) rejection above) 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 Gartner et al. (US 20070027456) [hereinafter Gartner] and Graber (US 5190561) 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 filament (interpreted as the suture of claim 1, see 112(b) rejection above) 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 filament 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 filament 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 filament (interpreted as the suture of claim 1, see 112(b) rejection above) 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 filament 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 filament 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 filament 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 filament (interpreted as the suture of claim 1, see 112(b) rejection above) 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 filament 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 filament 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 a 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).
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). However, 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 filament (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 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 Graber, Avneri, and Gartner discloses wherein the filament (interpreted as the suture of claim 14; see 112b rejection above) 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 filament 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 filament 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).
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). However, 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 filament (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 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 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 filament 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 filament 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 Gartner et al. (US 20070027456) [hereinafter Gartner] and Graber (US 5190561) 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 abov ein 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Thursday 7:30am-5:30 pm.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771