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 .
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, line 7 “the longitudinal axis” is believed to be in error for --a longitudinal axis--. Appropriate correction is required.
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.
Claim 10 is 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. Claim 10, lines 3-4 recite “wherein the base layer is not coupled to the frame”. Claim 1, line 8 recites “a base layer disposed between the cushioning layer and the frame”. It is unclear how the base layer can be disposed between the cushioning layer and the frame (claim 1) and the cushioning layer is coupled to the frame at first and second locations (claim 10), while the base layer is not coupled to the frame. All of the figures of the application show the base layer either directly or indirectly coupled to the frame. Please clarify what is meant by “the base layer is not coupled to the frame”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 7, 13, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by 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).
Regarding claim 1, Levi discloses an implantable prosthetic device 10 (fig. 1), comprising: a frame 12 movable between a radially compressed and a radially expanded configuration (par.64), the frame comprising an inflow end portion 16, an outflow end portion 18, and a plurality of struts 26; and a sealing member 30 disposed around the frame, the sealing member comprising: a cushioning layer 48A-C comprising a plurality of texturized yarns 44 extending along a longitudinal axis of the frame (figs. 1-3; par.79 discloses the warp and weft yarns 50, 52 can comprise texturized yarns; par.75 discloses yarns 44 are formed by weft yarns 52 therefore Levi discloses texturized longitudinal yarns 44), and a base layer 38 disposed between the cushioning layer and the frame (fig.1).
Regarding claim 3, see base layer 38 in figs.1-3 which show a plain weave fabric including perpendicular warp 50 and weft 52 yarns.
Regarding claim 7, see fig.1 which shows the outflow end portion of base layer 38 being directly coupled to the frame with sutures 41 and an inflow end portion of the cushioning layer being coupled to the frame at least indirectly through the cushioning layer’s connection to the base layer.
Regarding claims 13-14, see the cross hatch marks (near the inflow edge) on base layer 38 in fig.1 for the base layer 38 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.
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 1-9 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). Note: this rejection is based on a different embodiment of Levi from the rejection under 35 U.S.C. 102 above.
Regarding claim 1, 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), the sealing member comprising: a cushioning layer 212, 300, 1000 comprising a plurality of texturized yarns 220, 306, 1010 extending 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 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 claim 1.
Regarding claim 2, see Levi par.129 for the sealing member being resiliently stretchable.
Regarding claim 3, see base layer 211 in fig. 9 of Levi which shows a plain weave fabric including perpendicular warp and weft yarns.
Regarding claim 4, 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.
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, Levi fig.9 shows the claimed portions either directly or indirectly coupled to the frame.
Regarding claims 8 and 9, 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 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, 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 1, 2, 5-7, 15-18, and 20 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.
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 disposed around the frame, 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 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 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.
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).
Regarding claims 18 and 20, see Haivatov par.105 for the sealing member being folded and sutured into a cylindrical shape. Claim 20 only requires that the edges “can be” coupled together via a chain stitch. The edges of the sealing member of Haivatov in view of Levi are capable of being coupled together via a chain stitch.
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi 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 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 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 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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi as applied to claim 18 above, and further in view of Tayeb et al. US 2017/0056163 (hereafter referred to as Tayeb). Haivatov in view of Levi discloses the implantable prosthetic device of claim 18, but Haivatov in view of Levi does not disclose that the sealing member comprises one or more 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.
Tayeb teaches an implantable prosthetic device, in the same field of endeavor, wherein a sealing member 200 comprises one or more circumferentially extending yarns 220 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) 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.
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Haivatov in view of Levi as applied to claim 20 above, and further in view of Eblacas et al. US 2013/0123900. Haivatov in view of Levi discloses the implantable prosthetic device of claim 20 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, wherein the chain stitch passes one or more times over a joint where the first and second edges abut (the examiner interprets claims 21-22 as positively reciting a chain stitch based on “is disposed” and “passes”).
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.
Conclusion
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/MEGAN Y WOLF/
Primary Examiner, Art Unit 3774