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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/8/2026 has been entered.
Response to Arguments
Applicant's arguments filed 1/8/2026 have been fully considered, but they are moot in view of the new grounds of rejection necessitated by the amendments.
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 1-6, 16, 17, 26, 27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Gabbay US 6,368,348 (hereafter referred to as Gabbay) in view of Lim et al. US 2005/0256567 (hereafter referred to as Lim) in further view of Feins et al. WO 2017/143075 (hereafter referred to as Feins).
Regarding claim 1, Gabbay discloses an annuloplasty ring prosthesis 10 comprising a frame 12 comprising an outer surface 30, and a cover 20 surrounding the outer surface of the frame (figs. 1 and 1b), wherein the cover comprises a bioprosthetic tissue (col.3, lines 41-50 disclose the cover 20 is fixed pericardium that is cross-linked with glutaraldehyde), wherein the cover is formed as a sheet having a first edge 26 and a second edge 28, wherein the sheet covers the outer surface of the frame and the first edge and the second edge are joined together to form a seam 32 adjacent the outer surface of the frame, wherein the seam extends along the first edge and the second edge and along the length of the frame (figs.1 and 1b). Gabbay discloses the invention substantially as claimed but does not disclose that the first edge and the second edge of the sheet fold or roll upon each other at the seam, inward to the outer surface of the frame to form a lip which comprises a folded or rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame.
Lim teaches an annuloplasty ring having a frame 20 and a cover 40, in the same field of endeavor, wherein the cover 40 is formed as a sheet having a first edge 48a and a second edge 48b (fig.5), the first edge and the second edge of the sheet fold or roll upon each other at the seam, inward to the outer surface of the frame 20 to form a lip 50 which comprises a folded or rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame (fig.5) for the purpose of creating a thicker cuff that provides more cushioning (par.24).
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 joining of the edges of the cover of Gabbay to include the first edge and the second edge of the sheet folded upon each other at the seam inward to the outer surface of the frame to form a lip which comprises a folded or rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame as taught by Lim in order to create a thicker cuff that provides more cushioning (Lim par.24). Note that Lim teaches the seam of fig. 5 is an alternative to the seam of fig. 4 which is identical to the seam of Gabbay. Gabbay and Lim both disclose sutures for joining the edges of the cover together and do not disclose that the edges are glued together to form the seam.
Feins teaches an annuloplasty ring prosthesis, in the same field of endeavor, wherein a cover can begin as a flat sheet that is wrapped around the inner core and held closed by an adhesive or suture (pg.15, lines 18-24).
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 annuloplasty ring of Gabbay in view of Lim by substituting glue for suture for joining edges of the cover as taught by Feins in order to hold the cover around the frame. A person of ordinary skill in the art would have been motivated to substitute glue for suture since it would have been a simple substitution of one known element for another to obtain predictable results (see MPEP 2143B).
Regarding claims 2-6, see Gabbay col.3, lines 41-50 which disclose pericardium that is cross-linked with glutaraldehyde.
Regarding claims 16 and 17, see Gabbay col.3, lines 26-29 for at least stainless steel.
Regarding claims 26, 27, and 30, Gabbay discloses the frame may be a plastic-like material like a polymer or a metal (col.3, lines 23-29), but does not disclose that the frame is a bioabsorbable metal or polymer.
Feins teaches an annuloplasty ring prosthesis, in the same field of endeavor, wherein the inner core/frame can be erodible metal (pg.12 lines 25-28) or biodegradable polymer including PGS which is a polyester (pg.9, line 29-pg.10, line 3) for the purpose of allowing for the device to grow with surrounding tissue (abstract).
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 frame material of Gabbay to include a bioabsorbable metal or polymer such as PGS as taught by Feins in order to allow for the frame to degrade over time to allow the device to grow with surrounding tissue. It would have been further obvious to select the bioabsorbable frame materials taught by Feins for the frame of Gabbay since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Claims 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Gabbay in view of Lim and Feins as applied to claims 2 and 5 above, and further in view of Carpentier et al. US 2012/0123557 (hereafter referred to as Carpentier). Gabbay in view of Lim and Feins discloses the annuloplasty ring of claims 2 and 5 as discussed above including that the fixed non-regenerative bioprosthetic tissue is pericardium that is cross-linked with glutaraldehyde (Gabbay col.3, lines 41-50). However, Gabbay in view of Lim and Feins does not disclose that the pericardium is subjected to a capping treatment comprising a capping agent, wherein the capping agent comprises an amine and the capping treatment further comprises borohydride as a reducing agent, or that the bioprosthetic tissue is plasticized with a polyol.
Carpentier teaches bioprosthetic tissue, in the same field of endeavor, wherein pericardium that is fixed with glutaraldehyde is subjected to a capping treatment comprising a capping agent, wherein the capping agent comprises an amine and the capping treatment further comprises borohydride as a reducing agent (par.46-48) for the purpose of enhancing post-implantation durability (par.5). Carpentier further teaches wherein the bioprosthetic tissue is plasticized with a glycerol for the purpose of storing the bioprosthetic tissue in a dry state (par.12).
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 pericardium that is fixed with glutaraldehyde of Gabbay in view of Lim and Feins to further be subjected to a capping treatment comprising a capping agent, wherein the capping agent comprises an amine and the capping treatment further comprises borohydride as a reducing agent as taught by Carpentier in order to enhance post implantation durability of the prosthesis. It would have been further obvious to modify the pericardium that is fixed with glutaraldehyde of Gabbay in view of Lim and Feins to be plasticized with glycerol as taught by Carpentier in order to allow for storage of the prosthesis in a dry state.
Claims 1 and 16-25 are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Matheny US 2016/0166730 (hereafter referred to as Matheny).
Regarding claims 1 and 18, Lim discloses an annuloplasty ring prosthesis 10 comprising a frame 20 comprising an outer surface (fig.5) and a cover 40 surrounding the outer surface of the frame (fig.5), wherein the cover is formed as a sheet having a first edge 48a and a second edge 48b, wherein the sheet covers the outer surface of the frame and the first edge and the second edge are joined together to form a seam adjacent the outer surface of the frame (fig.5 shows the edges joined by suture 60), wherein the seam extends along the first edge and the second edge and along the length of the frame (figs. 5 and 7), wherein the first edge and the second edge of the sheet fold/roll upon each other at the seam inward to the outer surface of the frame to form a lip 50 which comprises a folded or rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame (fig.5). Lim discloses the invention substantially as claimed but does not disclose that the cover comprises a bioprosthetic tissue, or that the edges are glued together to form the seam.
Matheny teaches an annuloplasty prosthesis, in the same field of endeavor wherein an outer ring cover is formed of a regenerative bioprosthetic tissue (pars. 40, 47, 83-84) for the purpose of providing a material that reduces or eliminates harsh biological responses and the formation of inflammation and infection after deployment, treats damaged or diseased cardiovascular tissue, induces host tissue and/or cell proliferation, bioremodeling and regeneration of new tissue, and delivers active agents to tissue to produce a desired biological and/or therapeutic effect (pars. 25-29). Matheny further teaches that the cover is formed by securing opposing edges of a sheet together by glue or suturing (pars.128-129; fig.7A) for the purpose of securing the sheet in a tubular configuration (par.129).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the cover of Lim from the regenerative bioprosthetic tissue taught by Matheny in order to provide a material that reduces or eliminates harsh biological responses and the formation of inflammation and infection after deployment, treats damaged or diseased cardiovascular tissue, induces host tissue and/or cell proliferation, bioremodeling and regeneration of new tissue, and delivers active agents to tissue to produce a desired biological and/or therapeutic effect. It also would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify Lim by substituting glue for the suture for forming the seam since Matheny teaches glue and sutures are obvious equivalents for securing edges of a cover together.
Regarding claims 16 and 17, Lim discloses the frame/core 20 comprises stainless steel and/or Elgiloy (par.26).
Regarding claims 19-25, Lim in view of Matheny discloses the annuloplasty ring of claim 18 as discussed above. Matheny further teaches the bioprosthetic tissue comprises decellularized ECM from at least SIS, bladder, liver, or heart (pars. 83-84) or the bioprosthetic tissue comprises an artificial polymer scaffold comprising PGA (par.40) wherein the artificial scaffold further comprises collagen I-V (par.47) for the purpose of providing a material that reduces or eliminates harsh biological responses and the formation of inflammation and infection after deployment, treats damaged or diseased cardiovascular tissue, induces host tissue and/or cell proliferation, bioremodeling and regeneration of new tissue, and delivers active agents to tissue to produce a desired biological and/or therapeutic effect (pars. 25-29). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select the bioprosthetic tissue materials taught by Matheny for the cover material of Lim in order to improve biocompatibility and enhance tissue ingrowth. It would have further obvious to select the known materials as taught by Matheny for the material forming the cover of the prosthesis of Lim since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Claims 1-6, 26, 27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Feins et al. WO 2017/143075 (hereafter referred to as Feins) in view of Gabbay in further view of Lim.
Regarding claims 1-6, Feins discloses an annuloplasty ring prosthesis 1 (figs. 3A-4B) comprising a frame 10 comprising an outer surface, and a cover 30 surrounding the outer surface of the frame (figs. 3A-3B), wherein the cover is formed as a sheet having a first edge and a second edge, wherein the sheet covers the outer surface of the frame and the first edge and second edge are glued together to form a seam adjacent the outer surface of the frame, wherein the seam extends along the first edge and the second edge and along the length of the frame (pg.15, lines 18-24 discloses the cover can begin as a flat sheet that is wrapped around the inner core and held closed by an adhesive or suture). Feins discloses the inner core can be erodible metal (pg.12, lines 25-28) or biodegradable polymer (pg.9, line 29-pg.10, line 3) and the cover can be made of any suitable material including UHMWPE, PTFE, ECTFE, or nitinol (pg.15, lines 11-14). Feins discloses the invention substantially as claimed but does not disclose that the cover comprises a bioprosthetic tissue, wherein the bioprosthetic tissue is a fixed, non-regenerative bioprosthetic tissue comprising pericardium fixed with glutaraldehyde.
Gabbay teaches an annuloplasty ring, in the same field of endeavor, wherein the annuloplasty ring comprises a cover made from pericardium fixed with glutaraldehyde for the purpose of improving biocompatibility and mitigating calcification and thrombus formation (col.3, lines 41-50).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select pericardium fixed with glutaraldehyde as taught by Gabbay for the material of the cover of Feins in order to provide an annuloplasty device with improved biocompatibility that mitigates calcification and thrombus formation. It would have been further obvious to select the known material of pericardium fixed with glutaraldehyde as taught by Gabbay for the material forming the cover of Feins since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07). Feins in view of Gabbay discloses the invention substantially as claimed but does not disclose that the first edge and the second edge of the sheet fold or roll upon each other at the seam inward to the outer surface of the frame to form a lip which comprises a folded or rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame.
Lim teaches an annuloplasty ring having a frame 20 and a cover 40, in the same field of endeavor, wherein the cover 40 is formed as a sheet having a first edge 48a and a second edge 48b (fig.5), the first edge and the second edge of the sheet fold or roll upon each other at the seam, inward to the outer surface of the frame 20 to form a lip 50 which comprises a folded or rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame (fig.5) for the purpose of creating a thicker cuff that provides more cushioning (par.24).
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 joining of the edges of the cover of Feins to include the first edge and the second edge of the sheet folded upon each other at the seam, inward to the outer surface of the frame to form a lip which comprises a folded or rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame as taught by Lim in order to create a thicker cuff that provides more cushioning (Lim par.24). Since Feins teaches glue or sutures can be used to secure edges of the sheet, it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select glue for joining the edges to create the seam taught by Lim since Feins discloses glue and sutures are obvious functional equivalents for securing cover edges together.
Regarding claims 26, 27, and 30, Feins discloses the inner core/frame can be erodible metal (pg.12 lines 25-28) or biodegradable polymer including PGS which is a polyester (pg.9, line 29-pg.10, line 3).
Claims 28, 29, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Feins in view of Gabbay and Lim as applied to claims 26 and 27 above, and further in view of Papirov et al. US 2012/0215301 (hereafter referred to as Papirov). Feins in view of Gabbay and Lim discloses the annuloplasty ring of claims 26 and 27 as discussed above, but Feins does not specifically disclose that the biodegradable metal is magnesium or a magnesium alloy having an UTS of about 30 MPa to about 400 MPa and an elongation of about 0.3% to about 170%.
Papirov teaches an endoprosthesis, in the same field of endeavor, wherein the endoprosthesis comprises a biodegradable magnesium alloy having an UTS of 175 MPa and an elongation of 23% (par.126) for the purpose of providing a material having an optimal combination of strength, plasticity, and corrosion resistance in vivo thereby preventing premature mechanical failure (pars.14-15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to select a magnesium or a magnesium alloy having an UTS of about 30 MPa to about 400 MPa and an elongation of about 0.3% to about 170% as taught by Papirov as the biodegradable metal frame material of Feins in view of Gabbay and Lim in order to provide a frame that has optimal strength, plasticity, and corrosion properties. It would have been further obvious to select the known magnesium material taught by Papirov for the frame material of Feins in view of Gabbay and Lim since it has been held that selection of a known material based on its suitability for an intended use is an obvious extension of prior art teaching (In re Leshin 227 F.2d 197, 125 USPQ 416 (CCPA 1960) MPEP 2144.07).
Conclusion
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/MEGAN Y WOLF/Primary Examiner, Art Unit 3774