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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Arguments
Applicant's arguments filed 6/25/26 have been fully considered but they are not persuasive. The Applicant argued that Lenker’s sutures are not embedded in the liner, and that it would not be obvious to combine Reich with Lenker because Reich already discloses a mechanism by which controlled expansion takes place. However, Lenker teaches sutures directly connected to and within the liner in Fig. 6, and it would be obvious to modify Reich as taught by Lenker in order to provide both the liner with controlled expansion and avoid issues of material “creep” or fistulas (Lenker col 2 line 54). Further, Lenker’s FIG 6 illustrates sutures 118 remain embedded within liner 114 after breaking.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-3, 5, 7-11, 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reich (20220287834) in view of Lenker (5843158).
With regards to claim 1, Reich discloses a skirt (70) for an implantable prosthetic device (700), comprising: an annular fabric matrix (outer skirt 70; [0065], [0147]) radially expandable from a radially compressed configuration to a first diameter upon application of a radially outwardly directed force via the implantable prosthetic device ([0046]); and a plurality of frangible restriction filaments (704, 734), and each restriction filament having a selected maximum diameter different from that of at least one of the other restriction filaments ([0011]; [0157-0158]). Reich fails to disclose that the plurality of frangible restriction filaments are embedded in the fabric matrix, that each restriction filament being configured to break when a radially outwardly directed force applied to the restriction filament exceeds a predetermined threshold, and wherein the frangible restriction filaments remain embedded within the fabric matrix after breaking.
In an alternative embodiment, Reich teaches restriction filaments (322) being configured to break when a radially outwardly directed force applied to the restriction filament exceeds a predetermined threshold ([104]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Reich’s frangible restriction filaments (704, 734) being configured to break when a radially outwardly directed force is applied to the restriction filaments, as taught by the alternative embodiment, in order to allow the force exerted by the prosthetic implant on the native anatomy to be calculated ([0045]).
Reich as modified fails to disclose that the plurality of frangible restriction filaments are embedded in the annular fabric matrix. Lenker also discloses an outer fabric matrix (114) for an implantable prosthetic device (110), and teaches incorporating the frangible reinforcing element (118) in the liner (Fig. 6), wherein the frangible restriction filaments remain embedded within the fabric matrix after breaking (FIG 6 illustrates 118 remains embedded within 114 after breaking). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Reich’s skirt to have the plurality of frangible restriction filaments embedded in the fabric matrix, as taught by Lenker, in order to provide both the liner with controlled expansion and avoid issues of material “creep” or fistulas (col 2, line 54).
With regards to claim 2, Reich as modified by Lenker discloses the skirt of claim 1, wherein a first frangible restriction filament of the plurality of frangible restriction filaments (704, 734) is configured to break when the radially outwardly directed force exceeds a first predetermined threshold to allow radial expansion of the annular fabric matrix to a second diameter ([102, 103], [151], [0158]).
With regards to claim 3, Reich as modified by Lenker discloses the skirt of claim 2, wherein a second frangible restriction filament of the plurality of restriction filaments (704, 734) is configured to break when the radially outwardly directed force exceeds a second predetermined threshold to allow radial expansion of the annular fabric matrix to a third diameter ([102, 103], [151], [0158]).
With regards to claim 5, Reich as modified by Lenker discloses the skirt of claim 1, wherein the annular fabric matrix comprises woven polyethylene (PE) fabric ([0065]).
With regards to claim 7, Reich as modified by Lenker discloses the skirt of claim 1, wherein the frangible restriction filaments are woven into the fabric matrix in an in-and-out pattern ([0156, 103]; since they are woven in and out of the frame and the fabric matrix is disposed on the outer surface of the frame).
With regards to claim 8, Reich as modified by Lenker discloses the skirt of claim 1, wherein the predetermined threshold of force of each restriction filament of the plurality of frangible restriction filaments is the same ([0104]).
With regards to claim 9, Reich as modified by Lenker discloses the skirt of claim 1, wherein the plurality of frangible restriction filaments are woven in the fabric matrix such that each frangible restriction filament is in a slackened state when a diameter of the fabric matrix is less than the maximum diameter of the frangible restriction filament (FIG 18, 19, [0098]).
With regards to claim 10, Reich discloses a skirt (70) for an implantable prosthetic device (700), comprising: an annular body (outer skirt 70; [0065], [0147]) configured to extend around a circumference of the prosthetic device (700); one or more sets of frangible restriction filaments (704, 734) coupled to the annular body (70 covers 704, 734, thereby coupled); wherein the annular body (70) is radially expandable from a radially compressed configuration to a first diameter upon application of a radially outwardly directed force via the implantable prosthetic device ([0151]); and wherein the first set of frangible restriction filaments (704, 734) comprises a plurality of frangible restriction filaments (734a, 734b, 734c), each having the same diameter (FIG 19). Reich fails to disclose that the first set of frangible restriction filaments of the one or more sets of frangible restriction filaments is configured to break when the radially outwardly directed force exceeds a first predetermined threshold to allow radial expansion of the annular body to a second diameter, and that the one or more set of frangible restriction filaments remain embedded within the annular body when broken.
In an alternative embodiment, Reich teaches restriction filaments (322) being configured to break when a radially outwardly directed force applied to the restriction filament exceeds a predetermined threshold ([104]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Reich’s frangible restriction filaments being configured to break when a radially outwardly directed force is applied to the restriction filaments, as taught by the alternative embodiment, in order to allow the force exerted by the prosthetic implant on the native anatomy to be calculated ([0045]).
Reich as modified fails to disclose the one or more set of frangible restriction filaments remain embedded within the annular body when broken. Lenker also discloses an annular body (114) for an implantable prosthetic device (110), and teaches incorporating the frangible reinforcing element (118) in the liner (Fig. 6) and that the one or more set of frangible restriction filaments remain embedded within the annular body when broken (FIG 6 illustrates 118 remains embedded within 114 after breaking). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Reich’s annular body to have the plurality of frangible restriction filaments embedded therein such that they remain embedded within the annular body when broken, as taught by Lenker, in order to provide both the liner with controlled expansion and avoid issues of material “creep” or fistulas (col 2, line 54).
With regards to claim 11, Reich as modified by Lenker discloses the skirt of claim 10, wherein a second set of frangible restriction filaments of the one or more sets of restriction filaments (704, 734) is configured to break when the radially outwardly directed force exceeds a second predetermined threshold to allow radial expansion of the annular body to a third diameter ([0102], [0151], [0158]).
With regards to claim 13, Reich as modified by Lenker discloses the skirt of claim 10, wherein the annular body comprises woven polyethylene (PE) fabric ([0065]).
With regards to claim 14, Reich as modified by Lenker discloses the skirt of claim 10, wherein the sets of frangible restriction filaments are coupled to the annular body by weaving the sets of frangible restriction filaments into a weave of the annular body ([0156], [0103]; since they are woven in and out of the frame and the annular body is disposed on the outer surface of the frame).
With regards to claim 15, Reich as modified by Lenker the skirt of claim 10, wherein the sets of frangible restriction filaments (704, 734) are coupled to the annular body using one or more sutures ([0155]).
With regards to claim 16, Reich as modified by Lenker discloses the skirt of claim 10, wherein each set of frangible restriction filaments (704, 734) has a selected maximum diameter different from the selected maximum diameters of the other sets of frangible restriction filaments ([0104], [0151], [0157]).
With regards to claim 17, Reich as modified by Lenker discloses the skirt of claim 10, wherein the skirt comprises first, second, and third sets of frangible restriction filaments ([0102], [0151], [0157-0158], “The process of expansion and breakage can continue until the prosthetic valve has reached a selected size").
With regards to claim 18, Reich as modified by Lenker discloses the skirt of claim 17, wherein the first set of frangible restriction filaments has a maximum diameter less than a maximum diameter of the second set of frangible restriction filaments, and wherein the third set of restriction filaments has a maximum diameter greater than the maximum diameters of the first and second sets ([0151], [0158]).
With regards to claim 19, Reich as modified by Lenker discloses the skirt of claim 10, wherein the sets of frangible restriction filaments (704, 734) are disposed such that the filaments define a repeating pattern (FIGs 18-19).
With regards to claim 20, Reich as modified by Lenker discloses the skirt of claim 1, wherein the plurality of frangible restriction filaments comprise one or more sets of filaments (704, 734), each set comprising a plurality of filaments (734a, 734b, 734c) each having the same diameter such that multiple restriction filaments must break to expand to a larger diameter (FIG 19).
Claim(s) 4, 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Reich (20220287834) and Lenker (5843158) as applied to claims 1 and 10 above, and further in view of Nordstrom (5895413).
With regards to claim 4, Reich as modified by Lenker discloses the skirt of claim 1, but fails to disclose wherein the plurality of frangible restriction filaments comprise at least one of polyurethane (PU) and silicon. However, Reich as modified by Lenker does disclose the plurality of frangible restriction filaments may be sutures ([0105], [0106], [0172]). Nordstrom also discloses a medical suture (16; col 2 line 2) and teaches that it is formed of silicone (col 1 line 67). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Reich’s plurality of frangible restriction filaments to comprise silicon, as taught by Nordstrom, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended us as a matter of obvious design choice. In re Leshin, 125 USPQ 416 (note that the prior art does not need to disclose the limitation “polyurethane” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “at least one of”).
With regards to claim 12, Reich as modified by Lenker discloses the skirt of claim 10, but fails to disclose wherein the one or more sets of frangible restriction filaments comprise at least one of polyurethane (PU) and silicon. However, Reich as modified by Lenker does disclose the one or more sets of frangible restriction filaments may be sutures ([0105], [0106], [0172]). Nordstrom also discloses a medical suture (16; col 2 line 2) and teaches that it is formed of silicone (col 1 line 67). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Reich’s one or more sets of frangible restriction filaments to comprise silicon, as taught by Nordstrom, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended us as a matter of obvious design choice. In re Leshin, 125 USPQ 416 (note that the prior art does not need to disclose the limitation “polyurethane” to meet the claimed invention since the claim recites the limitations in the alternative only using the term “at least one of”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE FLORENCIA NERENBERG whose telephone number is (571)272-9599. The examiner can normally be reached M-F 7:30-5.
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/R.F.N./Patent Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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