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, 3-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (US Pub No.: 2020/0113720) in view of Taylor (US Pub No.: 2020/0121441).
Regarding claim 1, Jacobs (US Pub No.: 2020/0113720) discloses a device (gastrointestinal device in the abstract), comprising an at least partially bioabsorbable (degradable material in the abstract comprising monofilaments in [0065]) configured to be disposed at least partially around a body portion comprising a sphincter of a patient (shown in figure 1A-1B with device part 6), and wherein the at least partially bioabsorbable matrix is configured to couple the body portion comprising the sphincter of the patient to an adjacent body portion (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]).
With respect to a matrix, Taylor (US Pub No.: 2020/0121441) does teach a matrix (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]).
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 matrix of Taylor into Jacobs for the purpose of providing a polymeric matrix that can deliver drugs to a patient body in [0058]-[0060], where the drugs can treat inflammation as per [0054].
Regarding claim 3, Jacobs in view of Taylor teach the device of Claim 1, wherein Jacobs discloses the at least partially bioabsorbable 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]).
Regarding claim 4, Jacobs discloses the device of claim 1. Jacobs does not disclose that the at least partially bioabsorbable matrix comprising a bioabsorbable filament.
Instead, Taylor (US Pub No.: 2020/0121441) teaches at least partially bioabsorbable matrix comprising a bioabsorbable filament (filaments in [0077], filaments with bioabosbable materials in [0096]).
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 5, Jacobs in view of Taylor teach the device of claim 4. Jacobs does not disclose the bioabsorbable filament comprises a constant filament density along a length of the at least partially bioabsorbable 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 6, Jacobs in view of Taylor teach the device of claim 4, wherein Jacobs discloses the at least partially bioabsorbable matrix is configured to be completely absorbed into a space exterior the body portion comprising the sphincter (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 comprising the sphincter, adjacent to the body portion comprising the sphincter, and combinations thereof (part 6 is viewed as being adjacent to a sphincter in figure 1A-1B and, as a sphincter is being tightened in the abstract, a placement by a sphincter is required).
Regarding claim 7, Jacobs in view of Taylor teach the device of claim 4. Jacobs does not teach the at least partially bioabsorbable matrix comprising a first end and a second end opposite the first end, wherein the bioabsorbable filament extends from the first end to the second end, and wherein the first end and the second end remain in non-touching relation to one another.
Taylor teaches that the at least partially bioabsorbable matrix comprising a first end and a second end opposite the first end (it stands to reason that the medical implant of the abstract of Taylor has two ends) , wherein the bioabsorbable filament extends from the first end to the second end (as the filaments of [0088]-[0090] are incorporated into Jacobs, the filaments that form a coil and yarn comprise the medical device, and extend from both ends of Taylor), and wherein the first end and the second end remain in non-touching relation to one another (in the configurations of 1B and 1C of Jacobs, as the left and right ends of part 6 do not touch, the fibers of Taylor when incorporated into Jacobs do not touch).
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 8, Jacobs in view of Taylor teach the device of claim wherein Jacobs discloses the at least partially bioabsorbable 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 fully circumferentially around the sphincter (fully circumferentially in figure 1A of Jacobs, partially circumferentially in figures 1B and 1C).
Regarding claim 9, Jacobs in view of Taylor teach the device of claim 4. Jacobs does not teach wherein the at least partially bioabsorbable matrix is configured to be disposed helically about the sphincter.
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 10, Jacobs in view of Taylor teach the device of claim 9, wherein Jacob teaches the at least partially bioabsorbable matrix comprises a first at least partially bioabsorbable matrix (Jacobs teaches degradable material in the abstract comprising monofilaments in [0065]),
However, Jacobs does not teach that the device further comprising: a second at least partially bioabsorbable matrix comprising a bioabsorbable filament, wherein the second at least partially bioabsorbable matrix is configured to be disposed at least partially around to the body portion comprising the sphincter of the patient, and wherein the second at least partially bioabsorbable matrix is configured to be disposed helically about the sphincter.
Instead, Taylor teaches the device further comprising: a second at least partially bioabsorbable matrix comprising a bioabsorbable filament (second portion of the plurality of filaments in [0096]), wherein the second at least partially bioabsorbable matrix is configured to be disposed at least partially around to the body portion comprising the sphincter of the patient (in [0096], where a second plurality of filaments is wound about a first plurality of filaments), and wherein the second at least partially bioabsorbable matrix is configured to be disposed helically about the sphincter (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).
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 11, Jacobs in view of Taylor teach the device of claim 10. Jacobs does not teach wherein the second at least partially bioabsorbable matrix is disposed concentrically within the first at least partially bioabsorbable matrix.
Instead, Taylor teaches wherein the second at least partially bioabsorbable matrix is disposed concentrically within the first at least partially bioabsorbable 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 12, Jacobs in view of Taylor teach the device of claim 10. Jacobs does not teach wherein the first at least partially bioabsorbable matrix and the second at least partially bioabsorbable matrix are stacked with respect to one another.
Instead, Taylor teaches wherein the first at least partially bioabsorbable matrix and the second at least partially bioabsorbable 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 13, Jacobs in view of Taylor teach the device of claim 9, wherein Jacobs the at least partially bioabsorbable matrix is configured to be disposed about the sphincter in a manner selected from the group consisting of a non-overlapping manner and an overlapping manner (in figures 1A-1C of Jacobs, part 6 is not depicted as overlapping itself. 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].
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (US Pub No.: 2020/0113720) in view of Taylor (US Pub No.: 2020/0121441) in further view of Fiebig (US Pub No.: 2020/0188080).
Regarding claim 2, Jacobs in view of Taylor teach the device of claim 1. However, Jacobs does not teach wherein the at least partially bioabsorbable 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 at least partially bioabsorbable 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).
Claim(s) 14-15, 17, and 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (US Pub No.: 2020/0113720) in view of Taylor (US Pub No.: 2020/0121441) in further view Belcheva (US Pub No.: 2011/0015684).
Regarding claim 14, Jacobs in view of Taylor teach the device of claim 4. Jacobs does not teach wherein the bioabsorbable filament comprises a first bioabsorbable filament (a first and second filament are present in [0096]).
Taylor teaches wherein the bioabsorbable filament comprises a first bioabsorbable filament (a first and second filament are present in [0096]), the at least partially bioabsorbable matrix comprising a second bioabsorbable filament (in [0096]).
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].
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 15, Jacobs in view of Taylor and Belcheva teach the device of claim 14. However, Jacobs does not teach wherein the second bioabsorbable filament is wound about the first bioabsorbable filament.
Instead, Taylor teaches wherein the second bioabsorbable filament is wound about the first bioabsorbable filament (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 17, Jacobs in view of Taylor and Belcheva teach the device of claim 14. Jacobs does not teach wherein the first bioabsorbable filament and the second bioabsorbable filament are woven together. Instead, Taylor teaches that the first bioabsorbable filament and the second bioabsorbable filament are woven together (disclosed in [0077] 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 19, Jacobs in view of Taylor and Belcheva teach the device of claim 14. However, Jacobs does not teach wherein the at least partially bioabsorbable matrix further comprises a third bioabsorbable filament having a third bioabsorption rate that is different from each of the first bioabsorption rate and the second bioabsorption rate.
Taylor teaches the matrix further comprises a third bioabsorbable filament (multiple filaments disclosed in [0096] of Taylor. As such, a third filament is present here).
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].
However, Taylor does not teach a 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 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].
Regarding claim 20, Jacobs in view of Taylor and Belcheva teach the device of claim 14, wherein Jacobs discloses the at least partially bioabsorbable 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 (fully circumferentially in figure 1A of Jacobs, partially circumferentially in figures 1B and 1C).
Claim(s) 16 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jacobs (US Pub No.: 2020/0113720) in view of Taylor (US Pub No.: 2020/0121441) in further view Belcheva (US Pub No.: 2011/0015684) and Parsonage (US Patent No.: 7,758,635).
Regarding claim 16, Jacobs in view of Taylor and Belcheva teach the device of claim 15,
However, said combination does not teach an instance wherein the first bioabsorbable filament comprises 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 an instance wherein the first bioabsorbable filament comprises 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.
Regarding claim 18, Jacobs in view of Taylor and Belcheva teach the device of claim 17. However, said combination does not teach wherein the at least partially bioabsorbable matrix comprises a shape selected from the group consisting of a cylindrical shape, a hollow tubular shape, and a flat woven shape.
Instead, Parsonage (US Patent No.: 7,758,635) does teach an instance wherein the first bioabsorbable filament comprises a shape selected from the group consisting of a cylindrical shape, a hollow tubular shape, and a flat woven shape (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.
Conclusion
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].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AREN PATEL whose telephone number is (571)272-0144. The examiner can normally be reached 7:00 - 4:30 M-Th.
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, Jerrah C. Edwards can be reached at (408) 918-7557. 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.
/AREN PATEL/Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
