Prosecution Insights
Last updated: October 23, 2026
Application No. 17/806,430

HYBRID ANNULOPLASTY RING FOR TRICUSPID OR MITRAL VALVE REPAIR

Final Rejection §103§112
Filed
Jun 10, 2022
Priority
Dec 12, 2019 — provisional 62/947,454 +1 more
Examiner
WOLF, MEGAN YARNALL
Art Unit
3774
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Edwards Lifesciences Corporation
OA Round
4 (Final)
61%
Grant Probability
Moderate
5-6
OA Rounds
0m
Est. Remaining
99%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allowance Rate
379 granted / 621 resolved
-9.0% vs TC avg
Strong +39% interview lift
Without
With
+39.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
25 currently pending
Career history
658
Total Applications
across all art units

Statute-Specific Performance

§101
1.4%
-38.6% vs TC avg
§103
40.4%
+0.4% vs TC avg
§102
22.1%
-17.9% vs TC avg
§112
29.5%
-10.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 621 resolved cases

Office Action

§103 §112
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 6/22/2026 have been fully considered. Regarding the rejection of claims 1-6, 16, 17, 26, 27, and 30 under 35 U.S.C. 103 as being unpatentable over Gabby in view of Lim and Feins applicant argues Lim’s sewing cuff, which was relied upon for teaching the folded or rolled lip structure, is formed by squeezing or pinching the free edges together and securing them with sutures. Applicant argues this produces a sharply creased, pinched structure, not a smoothly convex, rolled portion as now recited in amended claim 1. While it’s true that Lim does not disclose “a smoothly convex, rolled portion”, this new limitation is directed to new matter and is indefinite as discussed in detail below. Applicant did not point out support for the new limitation. Fig.1D is the only figure that relates to the folded or rolled edges but does not show a smoothly convex, rolled portion as claimed. For examination, a configuration exactly like that of fig.1D is assumed for “a smoothly convex, rolled portion”. This new limitation is now taught by a different reference (Carpentier et al. US 6,231,602 which was cited by applicant in an IDS) as discussed in detail below. Because many of the previously relied upon references are still being used, arguments with respect to the other references are addressed herein. Applicant argues Feins teaches adhesive merely as an alternative to suture for holding a flat sheet closed around an inner core and does not disclose applying adhesive to a rolled portion of the bioprosthetic tissue sheet. This is not persuasive because Feins was relied upon to teach that sutures and adhesive are obvious equivalent means for securing a cover around an inner core. Par.100 of applicant’s own specification states “the first edge 131 and the second edge 132 can be sewn, glued, or otherwise joined together to form a seam 136”. Therefore, a person of ordinary skill in the art would have found it obvious to substitute glue for suture since this amounts to a simple substitution of one known element for another to obtain predictable results (see MPEP 2143B). Regarding the rejection of claims 1 and 16-25 under 35 U.C.S. 103 as being unpatentable over Lim in view of Matheny, applicant argues Lim does not disclose a smoothly convex, rolled portion. As discussed above, a new reference is now applied to teach this limitation as best understood. Applicant further argues that Matheny teaches glue as an alternative to suturing for securing opposing edges of a sheet in a tubular configuration but does not teach gluing rolled edges of a bioprosthetic tissue sheet to form a smoothly convex lip. This is not persuasive because Matheny was not relied upon for folded/rolled edges. Matheny was relied upon for teaching gluing or suturing edges of a bioprosthetic tissue sheet to form a tubular structure which clearly teaches glue and suture are obvious equivalents for securing edges of a sheet. Regarding the rejection of claims 1-6, 26, 27, and 30 under 35 U.C.S. 103 as being unpatentable over Feins in view of Gabbay and Lim, applicant argues none of the references disclose forming a smoothly convex, rolled lip from glued bioprosthetic tissue edges. As discussed above, a new reference is applied to teach the smoothly convex, rolled portion. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claims 1-13 and 16-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 requires “wherein the first edge and the second edge of the sheet roll upon each other at the seam inward to the outer surface of the frame to form a lip which comprises a smoothly convex, rolled portion of the sheet extending along the seam”. The specification does not use the term “smoothly convex” and fig.1D, which is the only figure that shows the edges rolled upon each other, does not appear to clearly show a smoothly convex, rolled portion. See the annotated fig.1D below. Since the specification does not disclose “smoothly convex” and the drawings do not clearly show a smoothly convex, rolled portion, the limitation is directed to new matter. PNG media_image1.png 420 898 media_image1.png Greyscale 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. Claims 1-13 and 16-31 are 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 1 recites “a smoothly convex, rolled portion”. The term “smoothly” in claim 1 is a relative term which renders the claim indefinite. The term “smoothly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. What is the scope of smoothly convex? Fig.1D shows a seam that has two rounded portions and a somewhat concave portion in the middle. How is this “smoothly convex”? The specification does not use this phrase and therefore does not provide a standard for determining the meaning or scope of the term. Also, the material of the cover in fig. 1D appears to be somewhat rough and not smooth (based on the dots and shading and par.116 and fig.5A which relate the shading to a rougher surface 504). Please clarify how the roughened sheet comprises a “smoothly convex, rolled portion”. 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 Carpentier et al. US 6,231,602 (hereafter referred to as Carpentier ‘602; cited in IDS) 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 roll upon each other at the seam, inward to the outer surface of the frame to form a lip which comprises a smoothly convex, rolled portion of the sheet extending Carpentier ‘602 teaches an annuloplasty ring having a frame 50 and a cover 44 (figs. 7 and 10), in the same field of endeavor, wherein the cover 44 is formed as a sheet having a first edge 44a and a second edge 44b (fig.10), the first edge and the second edge of the sheet roll upon each other at the seam, inward to the outer surface of the frame 50 to form a lip which comprises a smoothly convex, rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame (fig.10) for the purpose of providing a sheath for suturing the frame in place without obstructing blood flow (col.8, line 59-col.9, line 6). The examiner notes that “smoothly convex” is indefinite as discussed above, but since Carpentier ‘602 fig.10 shows a rounded lip identical to the lip of fig.1D of the application, Carpentier ‘602 is considered to teach a “smoothly convex, rolled portion” as best understood. 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 rolled upon each other at the seam inward to the outer surface of the frame to form a lip which comprises a smoothly, convex 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 Carpentier ‘602 in order to provide sufficient material for suturing the frame in place. Gabbay and Carpentier ‘602 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 Carpentier ‘602 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). Finally, Applicant’s own specification discloses in par.100 that “the first edge 131 and the second edge 132 can be sewn, glued, or otherwise joined together to form a seam 136”, therefore it is clear that suturing and gluing are both equally suitable for securing the edges and selecting glue instead of sutures would have been obvious. 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 Carpentier ‘602 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 ‘557). Gabbay in view of Carpentier ‘602 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 Carpentier ‘602 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 ‘557 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 ‘557 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 Carpentier ‘602 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 ‘557 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 Carpentier ‘602 and Feins to be plasticized with glycerol as taught by Carpentier ‘557 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 et al. US 2005/0256567 (hereafter referred to as Lim) in view of Matheny US 2016/0166730 (hereafter referred to as Matheny) in further view of Carpentier ‘602. 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. Lim in view of Matheny discloses the invention substantially as claimed, but the lip of Lim does not comprise a smoothly convex, rolled portion of the sheet. Carpentier ‘602 teaches an annuloplasty ring having a frame 50 and a cover 44 (figs. 7 and 10), in the same field of endeavor, wherein the cover 44 is formed as a sheet having a first edge 44a and a second edge 44b (fig.10), the first edge and the second edge of the sheet roll upon each other at the seam, inward to the outer surface of the frame 50 to form a lip which comprises a smoothly convex, rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame (fig.10) for the purpose of providing a sheath for suturing the frame in place without obstructing blood flow (col.8, line 59-col.9, line 6). The examiner notes that “smoothly convex” is indefinite as discussed above, but since Carpentier ‘602 fig.10 shows a rounded lip identical to the lip of fig.1D of the application, Carpentier ‘602 is considered to teach a “smoothly convex, rolled portion” as best understood. 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 lip of Lim to include a smoothly, convex 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 Carpentier ‘602 in order to provide sufficient material for suturing the frame in place. Further, a person of ordinary skill in the art would have been motivated to substitute the rounded lip taught by Carpentier ‘602 for the lip of Lim since it would have been a simple substitution of one known element for another to obtain predictable results (see MPEP 2143B). Finally, applicant has not disclosed that the “smoothly convex” configuration provides an advantage, is used for a particular purpose, or solves a stated problem (“a smoothly convex, rolled portion” is not discussed in applicant’s specification), therefore, the “smoothly convex, rolled portion” is an obvious matter of design choice which a person of ordinary skill in the art would have found obvious before the effective filing date of the claimed invention. 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 and Carpentier ‘602 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 in view of Gabbay in further view of Carpentier ‘602. 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 the first edge and the second edge of the sheet roll upon each other at the seam, inward to the outer surface of the frame to form a lip which comprises a smoothly convex, rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame. Carpentier ‘602 teaches an annuloplasty ring having a frame 50 and a cover 44 (figs. 7 and 10), in the same field of endeavor, wherein the cover 44 is formed as a sheet having a first edge 44a and a second edge 44b (fig.10), the first edge and the second edge of the sheet roll upon each other at the seam, inward to the outer surface of the frame 50 to form a lip which comprises a smoothly convex, rolled portion of the sheet extending along the seam and protruding outward from the seam and the outer surface of the frame (fig.10) for the purpose of providing a sheath for suturing the frame in place without obstructing blood flow (col.8, line 59-col.9, line 6). The examiner notes that “smoothly convex” is indefinite as discussed above, but since Carpentier ‘602 fig.10 shows a rounded lip identical to the lip of fig.1D of the application, Carpentier ‘602 is considered to teach a “smoothly convex, rolled portion” as best understood. 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 in view of Gabbay to include the first edge and the second edge of the sheet rolled upon each other at the seam inward to the outer surface of the frame to form a lip which comprises a smoothly, convex 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 Carpentier ‘602 in order to provide sufficient material for suturing the frame in place. 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 Carpentier ‘602 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 Carpentier ‘602 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 Carpentier ‘602 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 Carpentier ‘602 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 The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ryan et al. US 2007/0191939 discloses various configurations of a cover formed as a sheet, wherein the sheet edges are rolled inward and secured together to form a rounded outer portion. 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 EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /MEGAN Y WOLF/Primary Examiner, Art Unit 3774
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Prosecution Timeline

Show 1 earlier event
Apr 08, 2025
Non-Final Rejection mailed — §103, §112
Jul 07, 2025
Response Filed
Oct 10, 2025
Final Rejection mailed — §103, §112
Jan 08, 2026
Request for Continued Examination
Feb 06, 2026
Response after Non-Final Action
Mar 20, 2026
Non-Final Rejection mailed — §103, §112
Jun 22, 2026
Response Filed
Sep 14, 2026
Final Rejection mailed — §103, §112 (current)

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Prosecution Projections

5-6
Expected OA Rounds
61%
Grant Probability
99%
With Interview (+39.1%)
3y 6m (~0m remaining)
Median Time to Grant
High
PTA Risk
Based on 621 resolved cases by this examiner. Grant probability derived from career allowance rate.

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