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
Applicant's arguments filed 4/20/2026 have been fully considered but they are not persuasive. Claim 1 was amended to incorporate limitations from previous claims 18 and 19 which are now canceled, and to add the limitation “one or more yarns extending circumferentially along an entire length of the cushioning layer”. Applicant traverses the rejection of claim 19, now incorporated into claim 1, under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi and Tayeb. Applicant argues the office does not point to anything in Tayeb that discloses, teaches, or suggests yarns “extending circumferentially along an entire length of the cushioning layer and each having a first extending portion and a second extending portion, wherein the first and second extending portions can be tied together to couple the first and second edges of the sealing member”. Besides saying the Office does not point out the new limitation, Applicant does not explain how this new limitation overcomes the teachings of Tayeb. The argument is not persuasive because Tayeb shows two yarns 220 extending circumferentially along an entire length of a sealing member with each yarn having first and second extending portions extending beyond the sealing member (fig.6). These circumferentially extending yarns were discussed in the previous rejection of claim 19. It is unclear why adding “along an entire length of the cushioning member” would overcome the teachings of Tayeb and applicant does not explain this. Fig. 6 of Tayeb clearly shows each yarn 220 extends for the entire circumferential length of the sealing member. Par. 50 of Tayeb says the one or more threads 220 extend out of the ends, therefore each yarn extends for the entire circumferential length of the sealing member. As such, the rejection of claim 19, now incorporated into claim 1, is maintained.
Regarding claim 20, applicant argues the Office has not pointed to anything in the proposed combination of Haivatov and Levi that discloses, teaches, or suggests “first and second edges are coupled together via a chain stitch”, wherein the claim has been amended to positively recite a chain stitch. While it’s true that the rejection of claim 20 did not address this feature because the chain stitch was not positively claimed, claims 21 and 22 were rejected under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi in further view of Eblacas. The examiner explained that claims 21 and 22 were interpreted as positively reciting the chain stitch and Eblacas was applied to specifically teach a chain stitch for coupling edges together. Applicant did not address the rejection of claims 21 and 22 with any substantive argument. Accordingly, claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi in further view of Eblacas.
The examiner notes that the combination of claim 19 with each of claims 2-17 was not previously claimed, therefore there is a new ground of rejection (necessitated by the amendments) for claims 2-9 and 13-17.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 2, 5-7, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Haivatov et al. US 2018/0206982 (hereafter referred to as Haivatov) in view of Levi et al. US 2019/0046314 (hereafter referred to as Levi; published more than one year before the effective filing date of the claimed invention) in further view of Tayeb et al. US 2017/0056163 (hereafter referred to as Tayeb).
Regarding claim 1, Haivatov discloses an implantable prosthetic device 100 (fig.8), comprising: a frame 102 movable between a radially compressed and a radially expanded configuration (at least par.3 discloses an expandable prosthetic device), the frame comprising an inflow end portion 106, an outflow end portion 108, and a plurality of struts 104; and a sealing member 112 disposed around the frame and having a first edge and a second edge which are coupled together such that the sealing member forms a cylinder (par.105), the sealing member 112 (fig.12) comprising: a cushioning layer 116 comprising a plurality of texturized yarns (par.100), and a base layer 114 disposed between the cushioning layer and the frame (figs. 8 and 13). Haivatov discloses the implantable prosthetic device substantially as claimed but does not disclose that yarns of the cushioning layer extend in a linear configuration along a longitudinal axis of the frame.
Levi teaches an implantable prosthetic device, in the same field of endeavor, wherein a cushioning layer 212, 300, 1000 comprises yarns 220, 306, 1006 extending in a linear configuration in a longitudinal direction of the frame (figs. 9-20 and 32-37) for the purpose of providing a floating yarn portion that promotes sealing by obstructing blood flow past the sealing member and increasing the dwell time of blood in the vicinity of the yarns (par.90) and that can occupy voids or space in the anatomy and/or promote tissue growth into the floating yarn portions (par.131).
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 cushioning layer of Haivatov to include longitudinally extending yarns as taught by Levi in order to provide a floating yarn portion that provides improved sealing through filling spaces and promoting tissue ingrowth. Haivatov in view of Levi discloses the invention substantially as claimed, but does not disclose that the cushioning layer further comprises one or more yarns extending circumferentially along an entire length of the cushioning layer and each having a first extending portion and a second extending portion, and wherein the first and second extending portions can be tied together to couple the first and second edges of the sealing member.
Tayeb teaches an implantable prosthetic device, in the same field of endeavor, wherein a sealing member 200 comprises one or more yarns 220 each extending circumferentially along an entire length of the sealing member and each having a first extending portion and a second extending portion (fig.6 shows each yarn 220 extending from both sides of the sealing member), and wherein the first and second extending portions can be tied together to couple the first and second edges of the sealing member (fig.7 shows the yarn ends tied together to couple the edges) for the purpose of providing a separate accessory that can be easily attached to an existing prosthetic valve (par.52).
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 sealing member of Haivatov in view of Levi to include circumferentially extending yarns each having a first extending portion and a second extending portion, and wherein the first and second extending portions can be tied together to couple the first and second edges of the sealing member as taught by Tayeb in order to more easily attach the sealing member to the valve. The sealing member of Haivatov as modified to include the circumferentially extending yarns taught by Tayeb has yarns that extend along the entire circumferential length of the cushioning layer since the sealing member of Haivatov includes the cushioning layer, and each of the yarns, the sealing member, and cushioning layer extend around the entire circumference of the device.
Regarding claim 2, see Levi par.129 for the sealing member being resiliently stretchable.
Regarding claim 5, see Levi fig.9 and par.91 for the cushioning layer comprising first woven portion 216 at an outflow edge of the longitudinal yarns 220 and a second woven portion 214 at the inflow edge of the longitudinal yarns 220.
Regarding claim 6, see at least fig.9 of Levi which shows the longitudinal yarns 220 floating radially outward from/over the portions 214 and 216 of the cushioning layer.
Regarding claim 7, both Haivatov (fig.8) and Levi (fig.9) show the claimed portions either directly or indirectly coupled to the frame.
Regarding claim 15, Levi teaches the floating yarn portions can be elastic in par.116. Therefore, since the yarns can be both elastic and texturized, the cushioning layer taught by Levi comprises a plurality of elastic (and texturized) yarns extending along the longitudinal axis of the fame and interspersed with the texturized (and elastic) yarns.
Regarding claims 16 and 17, see Levi figs.34 and 39A-39J for leno weave portions, wherein the leno weave portion extends circumferentially around at least a portion of the cushioning layer (fig.34), wherein the leno weave portion comprises first and second leno yarns configured to trap one or more texturized longitudinally extending yarns between them (par.122; figs. 39C-J).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi and Tayeb as applied to claim 1 above, and further in view of Janardhan et al. US 8,715,314 (hereafter referred to as Janardhan). Haivatov in view of Levi and Tayeb discloses the implantable prosthetic device of claim 1. Haivatov further discloses that the base layer may be a woven fabric (par.97) but does not disclose that the base layer comprises a first set of yarns extending in a first direction and a second set of yarns extending in a second direction, and wherein the first and second sets of yarns are oriented at a non-perpendicular angle relative to one another, wherein the non-perpendicular angle is a 45 degree angle.
Janardhan teaches an implantable prosthetic device, in the same field of endeavor, wherein yarns form an angle relative to one another in a range of 0-180 degrees or 0-90 degrees (col.52, lines 4-10) wherein the angle influences the overall radial force and porosity of the prosthetic device (col.52, lines 21-28).
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 angle between the first and second yarns of the base layer of Haivatov in view of Levi and Tayeb such that they are non-perpendicular and 45 degrees depending on a desired strength and porosity of the base layer since Janardhan teaches tailoring the strength and porosity of a fabric by optimizing the angle between the yarns. Regarding the specific angle of 45 degrees claimed, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), MPEP 2144.05 II A), therefore since Janardhan teaches the general conditions of the claim, it would have been obvious to optimize the angle to 45 degrees as doing so would involve only routine skill in the art based on the teachings of Janardhan.
Claims 2-9 and 13-17 are rejected under 35 U.S.C. 103 as being unpatentable over Levi in view of Braido US 2015/0073545 (hereafter referred to as Braido) in further view of Tayeb.
Regarding claim 2, Levi discloses an implantable prosthetic device 200 (fig. 9), comprising: a frame 202 movable between a radially compressed and a radially expanded configuration (par.89), the frame comprising an inflow end portion 206, an outflow end portion 208, and a plurality of struts 204; and a sealing member 211 and 212, 300, or 1000 (par.116 says member 1000 can be incorporated into any of the outer coverings) disposed around the frame (fig.9), wherein the sealing member is resiliently stretchable between a first state corresponding to the radially expanded configuration of the frame and a second state corresponding to the radially collapsed configuration of the frame (par. 129), the sealing member comprising: a cushioning layer 212, 300, 1000 comprising a plurality of texturized yarns 220, 306, 1010 extending in a linear configuration along a longitudinal axis of the frame (figs.9, 17, and 32-37; pars.63 and 120), and a base layer 211 (fig.9). The embodiment of fig.9 comprises the base layer 211 secured to the interior surface of the frame and therefore Levi does not disclose that the base layer is disposed between the cushioning layer and the frame.
Braido teaches an implantable prosthetic device, in the same field of endeavor, wherein a cuff 106 can be disposed on an inner surface of the stent (fig.1), an outer surface of stent, or both an inner and outer surface of the stent (par.48).
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 implantable prosthetic device of Levi and move the base layer from the inner surface of the stent to the outer surface of the stent since Braido teaches both arrangements are suitable and since it has been held that rearrangement of parts without modifying the operation of the device would be an obvious extension of prior art teachings (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) MPEP 2144.04 VI C). In the instant case, moving the base layer 211 of Levi to the outer surface as taught by Braido does not modify the operation of the device and is an obvious extension of the prior art teachings. The implantable prosthetic device of Levi as modified to have the base layer 211 on the outer surface of the frame includes the base layer being located between the cushioning layer and the frame as required by the claim. Levi in view of Braido discloses the invention substantially as claimed but Levi in view of Braido does not disclose that the sealing member has a first edge and a second edge which are coupled together such that the sealing member forms a cylinder, or that the cushioning layer further comprises one or more yarns extending circumferentially along an entire length of the cushioning layer and each having a first extending portion and a second extending portion, and wherein the first and second extending portions can be tied together to couple the first and second edges of the sealing member.
Tayeb teaches an implantable prosthetic device, in the same field of endeavor, wherein a sealing member 200 has a first edge (edge near reference number 210 in fig.6) and a second edge (edge opposite the first edge in fig.6) which are coupled together such that the sealing member forms a cylinder (fig.7), wherein the sealing member comprises one or more yarns 220 each extending circumferentially along an entire length of the sealing member and each having a first extending portion and a second extending portion (fig.6 shows each yarn 220 extending from both edges of the sealing member), and wherein the first and second extending portions can be tied together to couple the first and second edges of the sealing member (fig.7 shows the yarn ends tied together) for the purpose of providing a separate accessory that can be easily attached to an existing prosthetic valve (par.52).
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 sealing member of Levi in view of Braido to include first and second edges that can be coupled together such that the sealing member forms a cylinder as well as circumferentially extending yarns each having a first extending portion and a second extending portion, and wherein the first and second extending portions can be tied together to couple the first and second edges of the sealing member as taught by Tayeb in order to more easily attach the sealing member to the valve. The sealing member of Levi as modified to include the circumferentially extending yarns taught by Tayeb has yarns that extend along the entire circumferential length of the cushioning layer since the circumferentially extending yarns taught by Tayeb and the cushioning layer of Levi extend for the entire circumference of the sealing member.
Regarding claim 3, see the rejection of claim 2 above and base layer 211 in fig. 9 of Levi which shows a plain weave fabric including perpendicular warp and weft yarns.
Regarding claim 4, see the rejection of claim 2 above and see fig.9 of Levi for the outflow end portion of base layer 211 comprising projections corresponding to the shape of the struts as evidenced by the top row of the sutures. Also see projections 308 in the embodiment of figs. 17-19 of Levi.
Regarding claim 5, see the rejection of claim 2 above and see Levi fig.9 and par.91 for the cushioning layer comprising first woven portion 216 at an outflow edge of the longitudinal yarns 220 and a second woven portion 214 at the inflow edge of the longitudinal yarns 220.
Regarding claim 6, see the rejection of claim 2 above and see at least fig.9 of Levi which shows the longitudinal yarns 220 floating radially outward from/over the portions 214 and 216 of the cushioning layer.
Regarding claim 7, see the rejection of claim 2 above and Levi fig.9 which shows the claimed portions either directly or indirectly coupled to the frame.
Regarding claims 8 and 9, see the rejection of claim 2 above and see the sealing member 300 of Levi figs. 17-19 and par.105 which discloses yarns 306 are located distally of the inflow end portion of the frame.
Regarding claims 13-14, see the rejection of claim 2 above and see the cross hatch marks on base layer 211 in fig.9 of Levi for the base layer 211 comprising first and second sets of yarns oriented at non-perpendicular angles relative to an inflow edge of the base layer, wherein the non-perpendicular angle is a 45 degree angle.
Regarding claim 15, see the rejection of claim 2 above. Levi further teaches the floating yarn portions can be elastic in par.116. Therefore, since the yarns can be both elastic and texturized, the cushioning layer taught by Levi comprises a plurality of elastic (and texturized) yarns extending along the longitudinal axis of the frame and interspersed with the texturized (and elastic) yarns.
Regarding claims 16 and 17, see the rejection of claim 2 above and see Levi figs.34 and 39A-39J for leno weave portions, wherein the leno weave portion extends circumferentially around at least a portion of the cushioning layer (fig.34), wherein the leno weave portion comprises first and second leno yarns configured to trap one or more texturized longitudinally extending yarns between them (par.122; figs. 39C-J).
Claims 20-22 are rejected under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi, and further in view of Eblacas et al. US 2013/0123900.
Regarding claims 20-22, Haivatov discloses an implantable prosthetic device 100 (fig.8), comprising: a frame 102 movable between a radially compressed and a radially expanded configuration (at least par.3 discloses an expandable prosthetic device), the frame comprising an inflow end portion 106, an outflow end portion 108, and a plurality of struts 104; and a sealing member disposed around the frame and having a first edge and a second edge which are coupled together such that the sealing member forms a cylinder (par.105), the sealing member 112 (fig.12) comprising: a cushioning layer 116 comprising a plurality of texturized yarns (par.100), and a base layer 114 disposed between the cushioning layer and the frame (figs. 8 and 13). Haivatov discloses the implantable prosthetic device substantially as claimed but does not disclose that the yarns of the cushioning layer extend in a linear configuration along a longitudinal axis of the frame.
Levi teaches an implantable prosthetic device, in the same field of endeavor, wherein a cushioning layer 212, 300, 1000 comprises yarns 220, 306, 1006 extending in a linear configuration in a longitudinal direction of the frame (figs. 9-20 and 32-37) for the purpose of providing a floating yarn portion that promotes sealing by obstructing blood flow past the sealing member and increasing the dwell time of blood in the vicinity of the yarns (par.90) and that can occupy voids or space in the anatomy and/or promote tissue growth into the floating yarn portions (par.131).
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 cushioning layer of Haivatov to include linearly and longitudinally extending yarns as taught by Levi in order to provide a floating yarn portion that provides improved sealing through filling spaces and promoting tissue ingrowth. Haivatov in view of Levi discloses the implantable prosthetic device as discussed above, including that the sealing member has edges that are sutured together to form a cylinder (Haivatov par.105), but, Haivatov in view of Levi does not disclose that the first and second edges are coupled together via a chain stitch, wherein the chain stitch is disposed in a sinusoidal pattern, and wherein the chain stitch passes one or more times over a joint where the first and second edges abut.
Eblacas teaches an implantable prosthetic device, in the same field of endeavor, wherein first and second edges 212 of a sleeve 210 can be coupled together via a chain stitch 204, wherein the chain stitch is disposed in a sinusoidal pattern (fig.2 shows the chain stitch crossing over and back across the joined edges), wherein the chain stitch passes one or more times over a joint where the first and second edges abut (figs. 2-3), for the purpose of holding a seam together (par.53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a chain stitch applied in a sinusoidal pattern across the edges of the sealing member of Haivatov in view of Levi as taught by Eblacas in order to hold the edges of the sealing device together since Eblacas teaches a chain stitch is a well-known technique for suturing ends of a sleeve together in the art of prosthetic devices.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 10 requires “wherein an inflow edge of the cushioning layer is coupled to the frame at a first location, wherein an outflow edge of the cushioning layer is coupled to the frame at a second location, and wherein the base layer is not directly coupled to the frame”. This limitation is understood by the examiner to mean that the base layer is attached only to the cushioning layer such that it floats over the frame as discussed in par.128 of the specification. Both Levi and Haivatov disclose a base layer sutured directly to the frame and therefore do not disclose a base layer that is not directly coupled to the frame.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sperling US 2017/0086964 discloses purse string sutures that can be woven into a sealing member (figs. 9A-9E).
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 MEGAN Y WOLF whose telephone number is (571)270-3071. The examiner can normally be reached Mon-Fri 8am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGAN Y WOLF/
Primary Examiner, Art Unit 3774
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