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 .
Election/Restrictions
Claims 15 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/25.
Claim Objections
Claims 6 and 11 are objected to because of the following informalities:
Claims 6 recite “radiopaque market” should be changed to read “radiopaque marker”. Appropriate correction is required.
Claims 11 recite “radiopaque market” should be changed to read “radiopaque markers”. Appropriate correction is required.
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 of this title, 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 1, 2, 4-6, 8, 9, 11-14, 16, 17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Cunningham (US2017/0209268) in view of Rowe (US2009/0319037) and Salahieh (US2007/0118214).
Regarding claim 1, Cunningham discloses a delivery assembly, comprising:
a prosthetic valve (202) movable between a radially compressed configuration and a radially expanded configuration (valve 202 is configured to be repositioned by being compressed and radially expanded, [0063]); and
a delivery apparatus (snare device 330) comprising:
a delivery shaft (390) extending distally from the user (see Fig. 9); and
a re-compression assembly comprising:
a re-compression shaft (380) extending through a lumen of the delivery shaft (see Fig. 10A); and
a re-compression member (370/376/220A) extending through a lumen of the re-compression shaft (see Figs. 10B) and having a loop portion (220A) configured to circumscribe the prosthetic valve (see Fig. 9),
wherein relative movement between the re-compression member and the re-compression shaft is configured to tighten the loop portion around the prosthetic valve ([0063]), thereby radially compressing the prosthetic valve ([0063]).
Cunningham does not explicitly disclose a handle for the delivery apparatus. Salahieh teaches a control assembly 400 (interpreted as the claimed handle) for delivering a valve. When ratchet element 405 is moved in the proximal direction, it transmits force through spring 412 to inner shaft 210 (re-compression shaft) to move the inner shaft proximal relative to outer shaft 220 (delivery shaft) ([0060]). The load or force necessary to sustain foreshortening of the braid and expansion of the apparatus 10 is supported by the spring element 412 which stretches ([0061]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the handle of Salahieh for the manipulator of Cunningham, since the substitution would have yielded the same predictable result of moving one shaft relative to another, while providing the added benefit of loading-sensing and displacement sensing capabilities ([0060])
Cunningham does not disclose the loop portion comprising at least one radiopaque marker. Rowe teaches an assembly for delivery of a heart valve, where the assembly has a component of a pusher tube 462 (interpreted as the re-compression shaft), locking member 460, and loop portion (interpreted as the loop portion) to allow for proper positioning of a support band 441 with the loop portion relative to valve leaflets ([0103], see Figs. 23-26). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the loop portion to include at least one radiopaque marker as taught by Rowe, in order to allow for proper positioning of the structures with the native structures of the heart when expanding and contracting the loop portion ([0103]).
Regarding claim 2, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1; yet, does not explicitly disclose wherein the at least one radiopaque marker comprises a plurality of radiopaque markers, spaced from each other along at least a portion of the loop portion. It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the invention of Cunningham/Rowe/Salahieh to comprise a plurality of radiopaque markers, since it has been held that mere duplication of essential working parts of a device involve only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further, Applicant has not disclosed that a plurality of radiopaque markers provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either designs as stated in paragraph [0195] of application specification. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify invention of Cunningham/Rowe/Salahieh to have the radiopaque markers spaced from each other along a portion of the loop portion as an obvious matter of design choice within the level of skill in the art.
Furthermore, absent a teaching as to criticality that having a plurality of radiopaque markers provides a benefit, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Regarding claim 4, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1; yet, does not explicitly disclose wherein the at least one radiopaque marker comprises a plurality of radiopaque markers spanning along a portion of the loop portion that is at least as long as half of the perimeter of the prosthetic valve when the prosthetic valve is in the radially expanded configuration. It would have been obvious to one having ordinary skill in the art at the effective filing date of the claimed invention to have modified the invention of Cunningham/Rowe/Salahieh to comprise a plurality of radiopaque markers, since it has been held that mere duplication of essential working parts of a device involve only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8. Further, Applicant has not disclosed that a plurality of radiopaque markers provides an advantage, solves any stated problem, or is used for any particular purpose and it appears that the device would perform equally well with either designs as stated in paragraph [0195] of application specification. Furthermore, absent a teaching as to criticality that having a plurality of radiopaque markers provides a benefit, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement. In re Kuhle, 526 F.2d 553,555,188 USPQ 7, 9 (CCPA 1975).
Applicant has not disclosed that the radiopaque markers spanning along a portion of the loop portion that is at least as long as half of the perimeter of the prosthetic valve when the prosthetic valve is in the radially expanded configuration provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0195] of the specification. One of ordinary skill in the art would have expected the invention of Cunningham/Rowe/Salahieh and Applicant’s invention to perform equally well with the radiopaque marker on the loop portion or the claimed radiopaque markers spanning along a portion of the loop portion that is at least as long as half of the perimeter of the prosthetic valve. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify invention of Cunningham/Rowe/Salahieh to have the radiopaque markers spanning along a portion of the loop portion that is at least as long as half of the perimeter of the prosthetic valve as an obvious matter of design choice within the level of skill in the art.
Regarding claim 5, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1, the modified invention discloses wherein the at least one radiopaque marker is disposed on the loop portion at a position corresponding to a contact region between the loop portion and the perimeter of the prosthetic valve (the radiopaque marker is disposed on the loop portion and would therefore contact the perimeter of the prosthetic valve).
Regarding claim 6, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 5, the modified invention discloses wherein the at least one radiopaque marker is disposed along a minimal marking length of the loop portion (the minimal marking length is interpreted as the length of the marker on the loop portion). However, the modified invention does not explicitly disclose wherein the minimal marking length is at least as great as the perimeter of the prosthetic valve in the radially expanded configuration. Applicant has not disclosed that the minimal marking length being as great as the perimeter of the prosthetic heart valve in the expanded configuration provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [0200] of the specification. One of ordinary skill in the art would have expected the invention of Cunningham/Rowe/Salahieh and Applicant’s invention to perform equally well with the minimal marking length of the modified invention or the claimed minimal marking length being as great as the perimeter of the prosthetic heart valve in the expanded configuration to perform the same determining a position of and repositioning the heart valve equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify invention of Cunningham/Rowe/Salahieh to have the minimal marking length being as great as the perimeter of the prosthetic heart valve in the expanded configuration as an obvious matter of design choice within the level of skill in the art.
Regarding claim 8, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1, Cunningham further discloses wherein the re-compression member further comprises a releasable connector (226A/276), wherein the releasable connector comprises a proximal connector (276) element and a distal connector (226A) element releasably attached to each other ([0062]), wherein the re-compression member comprises a proximal segment (segment defined by shaft 370) coupled to the proximal connector element, and wherein the loop portion is coupled to the distal connector element (see Fig. 9).
Regarding claim 9, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1, Cunningham further discloses wherein the prosthetic valve comprises a guide member (lumen of valve 202, see Fig. 9), and wherein at least a portion of the re-compression member extends through a lumen of the guide member (see Fig. 9).
Regarding claim 11, Cunningham discloses a delivery assembly, comprising:
a prosthetic valve (202) movable between a radially compressed configuration and a radially expanded configuration (valve 202 is configured to be repositioned by being compressed and radially expanded, [0063]); and
a delivery apparatus (snare device 330) comprising:
a delivery shaft (390) extending distally from the user (see Fig. 9); and
a re-compression assembly; comprising:
a re-compression shaft (380) extending through a lumen of the delivery shaft (see Fig. 10A), a re-compression member (376), a proximal segment (segment defined by shaft 370), and a loop portion (220A);
wherein the re-compression member extends through a lumen of the re-compression shaft (see Fig. 10A);
wherein the loop portion extends distally from the re-compression shaft (see Fig. 9);
wherein relative movement between the re-compression member and the re-compression shaft is configured to tighten the loop portion around the prosthetic valve ([0063]), thereby radially compressing the prosthetic valve ([0063]).
Cunningham does not explicitly disclose a handle for the delivery apparatus. Cunningham however discloses manipulation of the delivery shaft and re-compression shaft ([0062]). Salahieh teaches a control assembly 400 (interpreted as the claimed handle) for delivering a valve. When ratchet element 405 is moved in the proximal direction, it transmits force through spring 412 to inner shaft 210 (re-compression shaft) to move the inner shaft proximal relative to outer shaft 220 (delivery shaft) ([0060]). The load or force necessary to sustain foreshortening of the braid and expansion of the apparatus 10 is supported by the spring element 412 which stretches ([0061]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the handle of Salahieh for the manipulator of Cunningham, since the substitution would have yielded the same predictable result of moving one shaft relative to another, while providing the added benefit of loading-sensing and displacement sensing capabilities ([0060])
Cunningham does not disclose the re-compression shaft comprising at least one reference radiopaque marker, and the re-compression member comprising at least one indicator radiopaque marker; wherein the position of the at least one indicator radiopaque marker, relative to that of the at least one reference radiopaque marker, is indicative of the diameter of the prosthetic valve. Rowe teaches an assembly for delivery of a heart valve, where the assembly has a component of a pusher tube 462 (interpreted as the re-compression shaft), locking member 460, and loop portion (interpreted as the re-compression member) to allow for proper positioning of a support band 441 with the loop portion relative to valve leaflets ([0103], see Figs. 23-26). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the re-compression shaft to include at least one reference radiopaque marker, and the re-compression member to include at least one indicator radiopaque marker as taught by Rowe, in order to allow for proper positioning of the structures with the native structures of the heart when expanding and contracting the loop portion ([0103]). Where the modified invention of the re-compression shaft having at least one reference radiopaque marker and the re-compression member having at least one radiopaque marker would indicate the diameter of the prosthetic valve by determining the relative positions of the radiopaque markers. Where the at least one reference radiopaque marker includes the radiopaque markers of locking member 460 and pusher tube 462 which would be at two locations of the re-compression shaft.
Regarding claim 12, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 11, the modified invention further discloses wherein the at least one reference radiopaque marker comprises a plurality of reference radiopaque markers (Cunningham as modified by Salahieh teaches two reference radiopaque markers at different locations along the re-compression shaft, [0103] of Salahieh), wherein each reference radiopaque marker of the plurality of reference radiopaque markets is associated with a different diameter of the prosthetic valve (the modified invention is capable of having the radiopaque markers associated with the different diameters of the prosthetic valve as shown in Fig. 9 of Cunningham by moving the loop re-compression shaft to different locations on the body of the valve), and wherein alignment of a given indicator radiopaque marker with any one of the plurality of reference radiopaque markers is indicative of the diameter associated with a reference radiopaque aligned with the given indicator radiopaque marker.
Regarding claim 13, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 11; yet, does not explicitly disclose the modified invention discloses wherein the proximal segment comprises the at least one indicator radiopaque marker. Applicant has not disclosed that the proximal segment comprising at least one indicator radiopaque marker provides an advantage, is used for a particular purpose, or solves a stated problem. See paragraph [021] of the specification. One of ordinary skill in the art would have expected the invention of Cunningham/Rowe/Salahieh and Applicant’s invention to perform equally well with the radiopaque marker on the loop portion or the claimed proximal segment because both radiopaque marker locations would perform the same determining a position of and repositioning the heart valve equally well. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify invention of Cunningham/Rowe/Salahieh to have the proximal segment comprise at least one indicator radiopaque maker as an obvious matter of design choice within the level of skill in the art.
Regarding claim 14, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 11, Cunningham further discloses wherein the re-compression member further comprises a connector (226A/276) coupled to the proximal segment and the loop portion (see Fig. 9).
Regarding claim 16, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 14, Cunningham further discloses wherein the connector is a releasable connector (226A/276), wherein the connector comprises a proximal connector (276) element and a distal connector (226A) element releasably attached to each other ([0062]), wherein the proximal segment is coupled to the proximal connector element, and wherein the loop portion is coupled to the distal connector element (see Fig. 9).
Regarding claim 17, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 11, Cunningham further discloses wherein the prosthetic valve comprises a guide member (lumen of valve 202, see Fig. 9), and wherein at least a portion of the re-compression member extends through a lumen of the guide member (see Fig. 9).
Regarding claim 19, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 11, Cunningham further discloses further comprising a plurality of actuation arm assemblies (380/arm of hook 386) coupled to the prosthetic valve, wherein the plurality of actuation arm assemblies is configured to move the prosthetic valve between the radially compressed and the radially expanded configurations, wherein the plurality of actuation arm assemblies comprises a plurality of loop attachment members (hook of 386/226B), and wherein the loop portion is coupled to, and extends between, the plurality of loop attachment members (see Fig. 9).
Regarding claim 20, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 11, the modified invention further discloses wherein the handle further comprises a spring (412 of Salahieh) connected to the proximal segment (the spring 412 would be connected to the proximal segment by its connection to the shafts), wherein the handle is configured to apply an axially oriented pull-force on the proximal segment, and wherein the pull-force is sufficient to apply a minimal tension magnitude to the loop portion (Salahieh teaches the handle is configured to pull the inner shaft 210 proximal to the outer shaft 220, [0060]; where this pulling movement would be applied to the shafts of Cunningham in the same manner).
Claims 3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Cunningham (US2017/0209268) in view of Rowe (US2009/0319037) and Salahieh (US2007/0118214) as applied to claim 1; and further in view of Bashiri (US2010/0234935).
Regarding claim 3, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1; yet, does not explicitly disclose wherein the at least one radiopaque marker comprises radiopaque bands. Bashiri teaches a stent 40 that has one or more radiopaque markers 52 engaged thereto. Markers 52 comprise a coating of radiopaque material, a radiopaque band or fastener engaged to the backbone 45 or any other radiopaque mechanism suitable for use in a stent delivery system ([0059]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the radiopaque marker of Cunningham/Rowe/Salahieh to be radiopaque bands as taught by Bashiri, since the substitution of one radiopaque marker for another would have yielded the same predictable result of providing visualization of the implantable device.
Regarding claim 7, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1; yet, does not explicitly disclose wherein the at least one radiopaque marker comprises radiopaque coating. Bashiri teaches a stent 40 that has one or more radiopaque markers 52 engaged thereto. Markers 52 comprise a coating of radiopaque material, a radiopaque band or fastener engaged to the backbone 45 or any other radiopaque mechanism suitable for use in a stent delivery system ([0059]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the radiopaque marker of Cunningham/Rowe/Salahieh to be a coating as taught by Bashiri, since the substitution of one radiopaque marker for another would have yielded the same predictable result of providing visualization of the implantable device.
Claims 10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Cunningham (US2017/0209268) in view of Rowe (US2009/0319037) and Salahieh (US2007/0118214) as applied to claims 1 and 11 above, respectively; and further in view of Jensen (US2011/0125249).
Regarding claim 10, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 1; yet, is silent regarding wherein the prosthetic valve further comprises a sleeve disposed around at least a portion of the circumference of the prosthetic valve, and wherein at least a portion of the loop portion extends through the sleeve. Jensen teaches a stent-graft for repairing a valve ([0045]) that has a graft 42 (sleeve) disposed around the stent 46, 48, 50, and a loop 58 that extends through the graft by stitching in and out of the graft ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the frame of the prosthetic valve that is collapsed by the loop portion extending around it of Cunningham/Rowe/Salahieh for the frame with the sleeve with the loop portion that extends through the sleeve as taught by Jensen, since the substitution would have yielded the same predictable result of collapsing the implant for repositioning and providing the added benefit of providing a sealing graft material at the junction with tissue ([0068] of Jensen).
Regarding claim 18, Cunningham/Rowe/Salahieh makes obvious the delivery assembly of claim 11; yet, is silent regarding wherein the prosthetic valve further comprises a sleeve disposed around at least a portion of the circumference of the prosthetic valve, wherein at least a portion of the loop portion extends through the sleeve. Jensen teaches a stent-graft for repairing a valve ([0045]) that has a graft 42 (sleeve) disposed around the stent 46, 48, 50, and a loop 58 that extends through the graft by stitching in and out of the graft ([0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have substituted the frame of the prosthetic valve that is collapsed by the loop portion extending around it of Cunningham/Rowe/Salahieh for the frame with the sleeve with the loop portion that extends through the sleeve as taught by Jensen, since the substitution would have yielded the same predictable result of collapsing the implant for repositioning and providing the added benefit of providing a sealing graft material at the junction with tissue ([0068] of Jensen).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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/MIKAIL A MANNAN/Examiner, Art Unit 3774
/SARAH W ALEMAN/Primary Examiner, Art Unit 3774