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 . Claims 1-4, 6-9, 11-14, and 16-17 are pending and examined below.
Response to Arguments
Applicant's arguments filed 09/10/2025 have been fully considered but they are not persuasive. Applicant argues that the amendments to the independent claim overcome the rejections of record (pages 7-8) and that the dependent claims rise and fall with the same arguments (pages 7-8). Applicant's arguments are moot due to the additional reference applied to the newly added limitations, as detailed in the rejection below.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-4, 6, 11-14, & 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Soletti (US 20160302911 A1).
Regarding claim 1, Soletti teaches a cardiovascular medical implant (100, Fig. 1, ¶0071), comprising:
(a) a first electrospun component (110a, Fig. 3B) having a type of biodegradable (¶0105) electrospun polymers (110a, Fig. 3B, ¶0107);
(b) a second electrospun component (110b, Fig. 3B) having the same type of biodegradable (¶0105) electrospun polymers as in the first electrospun component (110a, Fig. 3B, ¶0117); and
(c) a support structure (210, Figs. 1 & 3B) for supporting the cardiovascular medical implant, wherein the support structure is a stent, a frame, a braided structure or a mesh structure (spine 210, ¶0080), wherein
the first electrospun component and the second electrospun component are assembled or joint together by the same type biodegradable electrospun polymers as in the first electrospun component and the second electrospun component (¶0117 & 0147), wherein
the support structure (210, Fig. 3B) is sandwiched in a space in between the first electrospun component (110a, Fig. 3B) and the second electrospun component (110b, Fig. 3B) such that the support structure (210, Fig. 3B) is laminated in between the assembled and joint together first electrospun component and the second electrospun component (210 is positioned between one or more layers of fiber matrix, Fig. 2B, ¶0111), and wherein
the assembled cardiovascular medical implant (100, Fig. 1, ¶0071) is a porous (¶0130), biodegradable (¶0105) surgical (¶0073) non-endoluminal and non-expandable implant (kink resistance, ¶0071-0072) capable of being replaced by naturally ingrown tissue over time upon implantation (¶0070).
Regarding claim 2, Soletti teaches
wherein the assembly or joint assembling the first electrospun component and the second electrospun component together is an ultrasonic weld or is a glued weld (adhesive, ¶0122).
Regarding claim 3, Soletti teaches
wherein the first electrospun component and the second electrospun component are components of a tissue engineered heart valve, a tissue engineered vascular graft, or a tissue engineered vessel (¶0071).
Regarding claim 4, Soletti teaches
wherein the first electrospun component and the second electrospun component are not sewn or stitched together, or the first electrospun component and the second electrospun component do not have any sewn areas or stitches (Soletti teaches adhesive therefore he would teach to not sew or stitch together the components, ¶0147).
Regarding claim 6, Soletti teaches
wherein the second electrospun component is separately manufactured from the first electrospun component (¶0147).
Regarding claim 11, Soletti teaches a method of assembling two separately manufactured electrospun components to form a cardiovascular medical implant (¶0074), comprising:
(a) electrospinning a first component (110a, Fig. 3B) using a type of biodegradable electrospun polymers (¶0105 & 0107);
(b) electrospinning a second component (110b, Fig. 3B) using the same type of biodegradable (¶0105) electrospun polymers as in the first component (¶0105 & 0107);
(c) having a support structure (210, Figs. 1 & 3B) for supporting the cardiovascular medical implant, wherein the support structure is a stent, a frame, a braided structure or a mesh structure (spine 210, ¶0080); and
(d) assembling the first electrospun component and the second electrospun component by the same type biodegradable electrospun polymers as used in the first electrospun component and the second electrospun component (¶0117 & 0147), wherein
during the assembling the support structure is sandwiched in a space in between the first electrospun component and the second electrospun component such that the support structure becomes laminated in between the assembled and joint together first electrospun component and the second electrospun component (210 is positioned between one or more layers of fiber matrix, Fig. 2B, ¶0111), wherein
the assembled cardiovascular surgical non-endoluminal (100, ¶0071) and non- expandable (kink resistance, ¶0071-0072) implant (100, Fig. 1, ¶0071) is a porous (¶0130), biodegradable (¶0105) medical implant capable of being replaced by naturally ingrown tissue over time upon implantation (¶0070).
Regarding claim 12, Soletti teaches
wherein the assembling is ultrasonic welding, gluing or glue welding (adhesive, ¶0122).
Regarding claim 13, Soletti teaches
wherein the first electrospun component and the second electrospun component are components of a tissue engineered heart valve, a tissue engineered vascular graft, or a tissue engineered vessel (¶0071).
Regarding claim 14, Soletti teaches
wherein the first electrospun component and the second electrospun component are not sewn or stitched together, or the first electrospun component and the second electrospun component do not have any sewn areas or stitches (Soletti teaches adhesive therefore he would teach to not sew or stitch together the components, ¶0147).
Regarding claim 16, Soletti teaches
wherein the assembling step further comprises applying an assembling or bonding pattern to an area where the first electrospun component and the second electrospun component are assembled or joint together (pattern of fiber matrix 110, ¶0150).
Regarding claim 17, Soletti teaches
wherein the second component is electrospun separately from the first component (¶0147).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Soletti in view of Vidlund et al. (US 20140214159 A1) hereinafter, Vidlund.
Regarding claim 7, Soletti teaches
two separately manufactured electrospun components (110a & 110b, Fig. 3, ¶0117 & 0147, Soletti), each manufactured with the same type of biodegradable electrospun polymers (¶0105, Soletti), wherein
the two separately manufactured electrospun components are assembled or joint together by the same type biodegradable electrospun polymers (¶0117 & 0147, Soletti), wherein
the assembled tissue is a porous (¶0130, Soletti), biodegradable (¶0105, Soletti) surgical (¶0073, Soletti) non-endoluminal and non-expandable implant (kink resistance, ¶0071-0072, Soletti) capable of being replaced by naturally ingrown tissue over time upon implantation (¶0070, Soletti), wherein
the two separately manufactured electrospun components have in between them a support structure (210, Fig. 3B, Soletti) for supporting the tissue, wherein
the support structure is a stent, a frame, a braided structure or a mesh structure (spine 210, Fig. 1, ¶0080, Soletti), wherein
the support structure is sandwiched in a space in between the two separately manufactured electrospun components (110a & 110b, Fig. 3B, Soletti) such that the support structure is laminated in between the assembled and joint together two separately manufactured electrospun components (210 is positioned between one or more layers of fiber matrix, Fig. 2B, ¶0111, Soletti).
Soletti does not teach a tissue engineered heart valve. However, Vidlund teaches a multi-layer cover for a prosthetic heart valve (¶0017, Vidlund) wherein
a tissue engineered heart valve (110, Fig. 2, Vidlund), comprising:
two separately manufactured electrospun heart valve components (134 and another 134, Figs. 2A & 3B, ¶0399-0400, Vidlund),
each manufactured with the same type of biodegradable electrospun polymers (¶0399-0400, Vidlund), wherein
the assembled tissue engineered heart valve is a porous (¶0284, Vidlund), biodegradable surgical non-endoluminal (¶0288, Vidlund) implant capable of being replaced by naturally ingrown tissue over time upon implantation (¶0284, Vidlund), wherein
the two separately manufactured electrospun heart valve components have in between them a support structure (132, Figs. 2A & 3B, ¶0399-0400, Vidlund) for supporting the tissue engineered heart valve (110, Fig. 2, Vidlund), wherein
the support structure is a stent structure (132, Fig. 2A), a frame, a braided structure or a mesh structure, wherein the support structure is sandwiched in a space in between the two separately manufactured electrospun heart valve components such that the support structure is laminated in between the assembled and joint together two separately manufactured electrospun heart valve components (132, ¶0399-0400, Vidlund).
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 teachings of Soletti by incorporating a tissue engineered heart valve as taught by Vidlund in order to provide improved stability, in-growth of the prosthetic, maintain structural integrity over large cycles, addresses biocompatibility issues, address commissural regurgitation, and address hemocompatibility issues (of the heart implant) (¶0016, Vidlund).
Regarding claim 8, Soletti teaches
wherein the assembly or joint assembling the two separately manufactured electrospun heart valve components together is an ultrasonic weld or a glued weld (adhesive, ¶0122, Soletti).
Regarding claim 9, Soletti teaches
wherein the two separately manufactured electrospun heart valve components are not sewn or stitched together, or the two separately manufactured electrospun heart valve components do not have any sewn areas or stitches (Soletti teaches adhesive therefore he would teach to not sew or stitch together the components, ¶0147).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.X.W./Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774