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 Rejections - 35 USC § 103
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.
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.
Claim(s) 1-2 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor (US Pub No.: 2020/0121441) in view of Jacob (US Pub No.: 2020/0113720), Fiebig (US Pub No.: 2020/0188080), and Belcheva (US Pub No.: 2011/0015684).
Regarding claim 1, Taylor (US Pub No.: 2020/0121441) teaches A bioabsorbable scaffold (absorbable device in the abstract, scaffold per se in [0110]), comprising: a matrix comprising (in [0060] with a polymeric matrix. Filaments that are woven together in [0077] also constitute a matrix despite not being explicitly disclosed as one. Biodegrading in [0060], [0077], managed degradation in [0220]): a first bioabsorbable filament; and a second bioabsorbable filament (a first and second filament are present in [0096]).
Taylor does not teach wherein the matrix is configured to be disposed at least partially around a body portion or a sphincter of a patient.
Jacob (US Pub No.: 2020/0113720) teaches wherein the matrix is configured to be disposed at least partially around a body portion or a sphincter of a patient (in [0069], closure mechanism 15 is placed proximately to an organ, being the stomach part 4, while the device at least partially encircles an esophagus in [0069]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the material of Taylor into the sphincter treatment device of Jacob for the purpose of providing an absorbable filament to an absorbable gastroesophageal reflux preventer in the abstract of Jacobs.
Taylor does not teach wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter.
Instead, Fiebig (US Pub No.: 2020/0188080) wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter. (promote growth of scar tissue in [0048], tissue growth in [0063], where scar tissue contains collagen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the tissue ingrowth, with the coatings to provide said ingrowth presented in [0048] of Fiebig into Jacobs for the purpose of providing a way to grow tissue to repair an atrophy or degradation of a sphincter, as per the abstract and [0003] of Fiebig).
Taylor does not teach wherein the first bioabsorbable filament has a first bioabsorption rate and the second bioabsorbable filament has a second bioabsorption rate that is different from the first bioabsorption rate.
Belcheva (US Pub No.: 2011/0015684) teaches wherein the first bioabsorbable filament has a first bioabsorption rate and the second bioabsorbable filament has a second bioabsorption rate that is different from the first bioabsorption rate (in [0026], two biodegradable materials with different degradation rates disclosed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the two collagen biomaterials with different degradation rates as doing so would allow for the user to “alter the degradation time of the original material” as per [0026].
Regarding claim 2, Taylor in view of Jacob, Fiebig, and Belcheva teach the bioabsorbable scaffold of Claim 1, wherein Taylor teaches the second bioabsorbable filament is wound about the first bioabsorbable filament (in [0096] of Taylor).
Regarding claim 4, Taylor in view of Jacob, Fiebig, and Belcheva teach the bioabsorbable scaffold of Claim 1, wherein Taylor discloses the first bioabsorbable filament and the second bioabsorbable filament are woven together (disclosed in [0077] of Taylor)..
Regarding claim 5, Taylor in view of Jacob, Fiebig, and Belcheva teach the bioabsorbable scaffold of Claim 4, Taylor discloses wherein the matrix comprises a shape selected from the group consisting of a cylindrical shape, a hollow tubular shape, and combinations thereof (as Taylor teaches that the device includes stents and shunts in [0020], which are known in the art as having a hollow tubular shape. The Sphincter interfacing part of part 6 of Jacobs is also a hollow tubular shape).
Regarding claim 6, Taylor in view of Jacob, Fiebig, and Belcheva teach the bioabsorbable scaffold of Claim 4, wherein Taylor discloses the matrix comprises a flat woven shape (woven shape in [0077] of Taylor, where it stands to reason that the tighter or looser woven structure of [0077] can be arranged to be flat).
Regarding claim 7, Taylor in view of Jacob, Fiebig, and Belcheva teach the bioabsorbable scaffold of Claim 1, wherein Taylor discloses the matrix consists of 100% bioabsorbable material (as the device is disclosed as a bioabsorbable implant in [0003] of Taylor, the implant is disclosed as being fully bioabsorbable).
Regarding claim 8, Taylor in view of Jacob, Fiebig, and Belcheva teach the bioabsorbable scaffold of Claim 1, wherein Taylor discloses the matrix further comprises a third bioabsorbable filament (multiple filaments disclosed in [0096] of Taylor. As such, a third filament is present here).
Taylor does not teach that the third bioabsorbable filament is having a third bioabsorption rate that is different from each of the first bioabsorption rate and the second bioabsorption rate.
Instead, Belcheva does teach having third bioabsorbable filament is having a third bioabsorption rate that is different from each of the first bioabsorption rate and the second bioabsorption rate (a third material is implied in [0019] as “at least two different biodegradable materials” are disclosed. [0019] also discloses that the materials all “degrade at different rates of time upon implantation”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a third biomaterial with different degradation rates as doing so would allow for the user to “alter the degradation time of the original material” as per [0026].
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Taylor (US Pub No.: 2020/0121441) in view of Jacob (US Pub No.: 2020/0113720), Fiebig (US Pub No.: 2020/0188080), and Fiebig (US Pub No.: 2020/0188080) in further view of Parsonage (US Patent No.: 7,758,635).
Regarding claim 3, Taylor in view of Jacob, Fiebig, and Belcheva teach the bioabsorbable scaffold of Claim 2. Taylor in view of Jacob, Fiebig, and Belcheva do not teach wherein the first bioabsorbable filament comprises a shape selected from the group consisting of a cylindrical shape, a hollow tubular shape, and combinations thereof.
Instead, Parsonage (US Patent No.: 7,758,635) does teach the first bioabsorbable filament comprises a shape selected from the group consisting of a cylindrical shape, a hollow tubular shape, and combinations thereof (as per column 4 lines 52-65).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filament composition of Parsonage into the combination involving Taylor, as the filaments with the micelles “may be loaded with a therapeutic agent” as per column 2 lines 9-22, which would allow for the device of Taylor to deliver a medication into the body.
Claim(s) 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacob (US Pub No.: 2020/0113720) in view of Fiebig (US Pub No.: 2020/0188080).
Regarding claim 9, Jacob discloses a bioabsorbable scaffold, comprising: a matrix comprising: a first end; a second end opposite the first end (being the left and right parts of part 6 in figure 1B and 1C. absorbable material in the abstract, where part 6 acts as a scaffold to a sphincter in the abstract); and a bioabsorbable filament extending from the first end to the second end (the monofilament that is part of the absorbable material in [0065]), wherein the matrix is configured to be disposed at least partially around a body portion or a sphincter of a patient (in figures 1B and 1C of Jacob), wherein the first end and the second end remain in non-touching relation to one another (in figures 1B and 1C of Jacob).
Jacob does not teach wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter,
Instead, Fiebig (US Pub No.: 2020/0188080) teaches wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter (promote growth of scar tissue in [0048], tissue growth in [0063], where scar tissue contains collagen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the tissue ingrowth, with the coatings to provide said ingrowth presented in [0048] of Fiebig into Jacobs for the purpose of providing a way to grow tissue to repair an atrophy or degradation of a sphincter, as per the abstract and [0003] of Fiebig).
Regarding claim 10, Jacob in view of Fiebig teach the bioabsorbable scaffold of Claim 9, wherein the matrix is configured to be disposed around portions of the sphincter in a manner selected from the group consisting of partially circumferentially, a piecemeal fashion, and combinations thereof (partially circumferentially in figures 1B and 1C of Jacob).
Regarding claim 11, Jacob in view of Fiebig teach the bioabsorbable scaffold of Claim 9, wherein the matrix is configured to be disposed fully circumferentially around the sphincter (fully circumferentially in figures 1A of Jacob).
Regarding claim 12, Jacob in view of Fiebig teach the bioabsorbable scaffold of Claim 9, wherein the matrix is configured to expand in response to a natural expansion of the sphincter (As the device of Jacobs is “semi-rigid” in [0064], the device will accommodate for an expansion or a deformation of a sphincter as per [0064]).
Claim(s) 13-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacob (US Pub No.: 2020/0113720) in view of Fiebig (US Pub No.: 2020/0188080) in further view of Taylor (US Pub No.: 2020/0121441).
Regarding claim 13, Jacob in view of Fiebig teach the bioabsorbable scaffold of Claim 9. Jacob in view of Fiebig does not teach wherein the bioabsorbable filament comprises a constant filament density along a length of the matrix.
Taylor teaches the bioabsorbable filament comprises a constant filament density along a length of the at least partially bioabsorbable matrix (in some embodiments, like in [0214], a constant coil density is present in [0214], where the coils are comprised of a monofilament fiber also in [0214]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Regarding claim 14, Jacobs teach a bioabsorbable scaffold, comprising: a matrix comprising a bioabsorbable filament (being the left and right parts of part 6 in figure 1B and 1C. absorbable material in the abstract, where part 6 acts as a scaffold to a sphincter in the abstract), wherein the matrix is configured to be disposed at least partially around a body portion or a sphincter of a patient (in figures 1A-1C of Jacob),
Jacob does not teach wherein the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter, and wherein the matrix is configured to be disposed helically about the sphincter.
Instead, Fiebig (US Pub No.: 2020/0188080) teaches the matrix is configured to induce a formation of collagen tissue about a portion of the sphincter (promote growth of scar tissue in [0048], tissue growth in [0063], where scar tissue contains collagen).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the tissue ingrowth, with the coatings to provide said ingrowth presented in [0048] of Fiebig into Jacobs for the purpose of providing a way to grow tissue to repair an atrophy or degradation of a sphincter, as per the abstract and [0003] of Fiebig).
Instead, Taylor teaches wherein the at least partially bioabsorbable matrix is configured to be disposed helically about the sphincter (helical orientation of filaments that form a matrix in [0096] of Taylor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Regarding claim 15, Jacob in view of Fiebig and Taylor teach the bioabsorbable scaffold of claim 14. Jacob does not teach wherein the matrix comprises a first matrix, the bioabsorbable scaffold further comprising: a second matrix comprising a bioabsorbable filament, wherein the second matrix is configured to be disposed on or adjacent to the body portion or the sphincter of the patient, and wherein the second matrix is configured to be disposed helically about the sphincter.
Instead, Taylor teaches wherein the matrix comprises a first matrix (being the first portion of the plurality of filaments in [0096]), the bioabsorbable scaffold further comprising: a second matrix comprising a bioabsorbable filament (second portion of the plurality of filaments in [0096]), wherein the second matrix is configured to be disposed on or adjacent to the body portion or the sphincter of the patient (sphincter placement in [0181] of Taylor. As the filaments of Taylor are implemented into the device of Jacobs, the filaments are disposed about the sphincter in Jacobs), and wherein the second matrix is configured to be disposed helically about the sphincter (helical orientation of filaments that form a matrix in [0096] of Taylor).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Regarding claim 16, Jacob in view of Fiebig and Taylor teach the bioabsorbable scaffold of claim 15. Jacob does not teach wherein the second matrix is disposed concentrically within the first matrix.
Taylor teaches wherein the second matrix is disposed concentrically within the first matrix (as the filaments are layered in [0096] of Taylor, the filaments and the matrix they comprise are disposed concentrically).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Regarding claim 17, Jacob in view of Fiebig and Taylor teach the bioabsorbable scaffold of claim 15. Jacob does not teach wherein the first matrix and the second matrix are stacked with respect to one another.
Taylor teaches wherein the first matrix and the second matrix are stacked with respect to one another (as the filaments are layered in [0096] of Taylor, the filaments and the matrix they comprise are stacked).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Regarding claim 18, Jacob in view of Fiebig and Taylor teach the bioabsorbable scaffold of claim 14. Jacob does not teach wherein the matrix is configured to be disposed about the sphincter in a non-overlapping manner.
Taylor teaches wherein the matrix is configured to be disposed about the sphincter in a non-overlapping manner (in figures 1A-1C of Jacobs, part 6 is not depicted as overlapping itself).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Regarding claim 19, Jacob in view of Fiebig and Taylor teach the bioabsorbable scaffold of claim 14. Jacob does not teach wherein the matrix is configured to be disposed about the sphincter in an overlapping manner.
Taylor teaches wherein the matrix is configured to be disposed about the sphincter in an overlapping manner. In the case of a helical orientation of the filaments presented in Taylor with respect to claim 9, the filaments will be overlapping in order to provide said helical orientation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Regarding claim 20, Jacob in view of Fiebig and Taylor teach the bioabsorbable scaffold of claim 14. Jacob does not teach wherein the matrix is configured to be completely absorbed into a space exterior the body portion or the sphincter, the space selected from the group consisting of contiguous with the body portion or the sphincter, adjacent to the body portion or the sphincter, and combinations thereof.
Taylor teaches wherein the matrix is configured to be completely absorbed into a space exterior the body portion or the sphincter (placement exterior to a body portion, shown in figure 1A-1B with part 6. As the device is disclosed as a bioabsorbable implant in [0003] of Taylor, the implant is disclosed as being fully bioabsorbable), the space selected from the group consisting of contiguous with the body portion or the sphincter, adjacent to the body portion or the sphincter, and combinations thereof (part 6 is adjacent to a sphincter in figure 1A-1C and, as a sphincter is being tightened in the abstract, a placement by a sphincter is required).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the filaments of Taylor into Bangera for the purpose of providing a filament that can provide a therapeutic agent to a body and is able to be placed a sphincter as per [0096], where a GI stent is disclosed, with an additional position-retaining end provided for in [0093].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nakayama (US Pub No.: 2022/0257362) discloses a stent in [0008] with details of a collagen prediction in [0079]. Koul (US Pub No.: 2022/0339324) teaches a biopolymer in the abstract that comprises a scaffold in [0001].
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/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
