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, see applicant's arguments and remarks, filed 04/03/2026, with respect to the rejection(s) of claim(s) 190-194, 196-201, 204-210, and 212-215 under St. Germain (US Pub No.: 2022/0000599) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Valimaa (US Patent No.: 6,709,452).
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: Regarding newly amended independent claim 214, prior art such as Taylor (US Pub No.: 2020/0121441), Fiebig (US Pub No.: 2020/0188080), Belcheva (US Pub No.: 2011/0015684), St. Germain (US Pub No.: 2022/0000599), Mauney (US Patent No.: 10,912,862) and Shank (US Pub No.: 2005/0113904), as well as the relevant prior art cited below (Nakayama (US Pub No.: 2022/0257362) and, Koul (US Pub No.: 2022/0339324)) are considered to be the best prior art to teach the presented limitations. However, as discussed in the interview dated 05/15/2024 for application 18/404,655, wherein the matrix is configured to couple the body portion or the sphincter of the patient to an adjacent body portion. As discussed in the interview between the present examiners, attorneys, and inventors, while the prior art did teach a placement of a scaffold like device by an esophagus was present, a coupling of that sphincter to an adjacent body position was not present. It is understood that this is present in pending application paragraph [0064] and figures 2E-2F, wherein the device is coupling the esophagus to the diaphragm. From here, prior art such as Shelton, IV (US Pub No.: 2020/0197015) and Aye (US Pub No.: 2018/0353278) were considered. However, Shelton IV, while teaching a coupling of secure bodies to an esophagus in [0042] did not specifically teach coupling of a body part to the esophagus. Aye did teach an attachment of a mesh to both an esophagus and diaphragm in the abstract and [0006] but, while the device itself is coupled to both parts, a coupling of the esophagus to a diaphragm was not disclosed here. As such, independent claim 204 with dependent claims 205-209 are allowable over prior art.
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) 190-191, 194, 197-198, 200, 213, and 215 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiebig (US Pub No.: 2020/0188080) in view of Valimaa (US Patent No.: 6,709,452).
Regarding claim 190, Fiebig (US Pub No.: 2020/0188080) teaches a scaffold (scaffold for a sphincter assistance device in figure 15-17B as per [0066]) for inducing an inflammatory response (promotion of a growth of scar tissue in [0048]), the scaffold comprising: a matrix comprising a plurality of bioabsorbable filaments (PGA threads in a bioabsorbable scaffold in [0072] and [0063]) wherein the matrix is configured to be disposed adjacent a sphincter within a patient (as the device is for a sphincter assistance with a placement by an exterior wall of an esophagus as per the abstract), and wherein the matrix is configured to fully bioabsorb adjacent to the sphincter (the device integrates absorbable materials as per [0063]. As the device is disclosed as being a sphincter assistance device that surrounds an esophagus in the abstract, absorption into the sphincter is implied), Wherein the matrix is configured to independently reinforce the sphincter (reinforcement buttress in [0070] that is placed around the LES in [0071]. As per [0068] and figures 15 and 16A, part 426 reinforces the sphincter, where part 426 is part of part 416 that is part of a matrix (426 being in 416 in [0068])).
However, Fiebig does not teach wherein the bioabsorbable filaments are configured to independently reinforce the sphincter.
Instead Valimaa (US Patent No.: 6,709,452) teaches wherein the bioabsorbable filaments (in column 6 lines 9-40) are configured to independently reinforce the sphincter (fibers for reinforcement in column 6 lines 9-40, reinforcing of a sphincter in column 3 lines 12-29. While a urethra is disclosed in column 3 lines 12-29, a disclosure to supporting, connecting, or separating elongated organs is present in column 1 lines 14-21 makes this art analogous to Fiebig).
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 support fibers of Valimaa for the purpose of providing a rigid support filament into Fiebig that reinforces the sphincter to be treated in Fiebig (reinforcement in column 6 lines 9-40) and allows for the device to degrade and leave the body (as per column 1 lines 14-21) while the fibers of Valimaa have multiple rates of degredation as per the abstract of Valimaa.
Regarding claim 191, Fiebig in view of Valimaa teach the scaffold of claim 190, wherein Fiebig discloses the matrix is configured to be disposed circumferentially around the sphincter (This is shown visually in figures 15 and 16A).
Regarding claim 194, Fiebig in view of Valimaa teach the scaffold of claim 190, wherein Fiebig discloses the scaffold is configured to induce the formation of a tissue collar adjacent the sphincter (placement of the device around a sphincter is shown in figure 15, and a promotion of scar tissue with the device is disclosed in [0068]. While a tissue collar is not explicitly disclosed here, as a scar tissue is being formed by the device in [0068], with the device wrapping around a sphincter in figure 15, scar tissue would form a collar).
Regarding claim 197, Fiebig in view of Valimaa teach the scaffold of claim 190, wherein Fiebig discloses the matrix comprises synthetic bioabsorbable filaments (PGA, disclosed in [0063], is a synthetic material that is in the threads of the scaffold).
Regarding claim 198, Fiebig in view of Valimaa teach the scaffold of claim 197, with Fiebig further comprising one or more nonbioabsorbable materials (non-absorbable materials in [0073]).
Regarding claim 200, Fiebig in view of Valimaa teach the scaffold of claim 190, wherein Fiebig discloses the matrix comprises polymeric bioabsorbable filaments (PGA fiber, disclosed in [0063] is a bioabsorbable polymer).
Regarding claim 213, Fiebig in view of Valimaa teach the scaffold of Claim 190, wherein Fiebig discloses the scaffold comprises a flat woven shape or a tubular shape (in Fiebig, the shape of the device is shown to be tubular in figures 2-3).
Regarding claim 215, Fiebig in view of Valimaa teach the scaffold of Claim 190, wherein Fiebig discloses the scaffold comprises a first end and a second end, and wherein the first end is configured to couple directly to the second end so as to secure the scaffold about the sphincter (in the embodiment shown in figure 3, two ends of part 30 are connected to each other via part 50, which is a fastener in [0043]. The first and second ends will be the two parts 30 to which part 50 joins).
Claim(s) 192-193 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiebig (US Pub No.: 2020/0188080) in view of Valimaa (US Patent No.: 6,709,452) in further view of Germain (US Pub No.: 2022/0000599).
Regarding claim 192, Fiebig in view of Valimaa teach the scaffold of claim 190. However, Fiebig does not teach an instance wherein the matrix is configured to be disposed hemi-circumferentially or partially circumferentially around the sphincter.
Instead, Germain (US Pub No.: 2022/0000599) does teach an instance wherein the matrix is configured to be disposed partially circumferentially around the sphincter (in the abstract, St. Germain discloses a sphincter reinforcement device to be placed at least partially around a body passage. A placement at least partially around a bodily passage is taken to be equivalent to a partially circumferential placement). 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 placement details of Germain into Fiebig as St. Germain teaches a placement of a medical device that is not present in Fiebig that allows for a specific treatment of various esophageal disorders, as per [0002] of Germain.
Regarding claim 193, Fiebig in view of Valimaa teach the scaffold of claim 190. However, Fiebig does not teach an instance wherein the matrix is configured to be disposed around portions of the sphincter in piecemeal fashion.
Instead, Germain (US Pub No.: 2022/0000599) does teach an instance wherein the matrix is configured to be disposed around portions of the sphincter in a piecemeal fashion (in the abstract, Germain discloses a sphincter reinforcement device to be placed at least partially around a body passage). 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 placement details of St. Germain into Fiebig as Germain teaches a placement of a medical device that is not present in Fiebig that allows for a treatment of various esophageal disorders, as per [0002] of St. Germain.
Claim(s) 196 and 201 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiebig (US Pub No.: 2020/0188080) in view of Valimaa (US Patent No.: 6,709,452) in further view of Folan (US Pub No.: 2020/0261205).
Regarding claim 196, Fiebig in view of Valimaa teach the scaffold of claim 190. However, Fiebig does not teach an instance wherein the matrix comprises a constant filament density along the length of the scaffold.
Instead, Folan (US Pub No.: 2020/0261205) teaches an instance wherein the matrix comprises a constant filament density along the length of the scaffold (part 12, disclosed as filaments in [0064], are depicted as having a constant density in figure 1).
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 arrangement of Folan into the device of Fiebig for the purpose of providing a braided structure of a stent device (in [0064]) not found in Fiebig, where said structure is known in the art to provide a structural stability to the device in a patient body.
Regarding claim 201, Fiebig in view of Valimaa teach the scaffold of claim 200. However, Fiebig does not further comprise gold particles disposed in or on a portion of the scaffold.
Instead, Folan (US Pub No.: 2020/0261205) does teach gold particles disposed in or on a portion of the scaffold (in [0128]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate gold particles found in Folan into Fiebig for the purpose of providing radiopaque materials that show up during an imaging, as per [0128]. This allows for the device of Folan to be able to be imaged during a medical procedure to determine the location of the device in the body, also in [0128].
Claim(s) 199 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiebig (US Pub No.: 2020/0188080) in view of Valimaa (US Patent No.: 6,709,452) in further view of Bluecher (US Pub No.: 2020/0030124).
Regarding claim 199, Fiebig in view of Valimaa teach the scaffold of claim 190, wherein Fiebig teaches that the matrix comprises polymeric bioabsorbable filaments (PGA fiber, disclosed in [0063] is a bioabsorbable polymer). However, Fiebig does not teach that the filaments are at least partially coated with at least one the following: a metal material, a ceramic material, a composite material, or a glass material (PEEK is disclosed in [0073], where PEEK is a carbon fiber composite material).
Instead, Bluecher (US Pub No.: 2020/0030124) discloses an instance wherein filaments are at least partially coated with at least one the following: a metal material, a ceramic material, a composite material, or a glass (a polymer stent coating is in the abstract, wherein the polymer is a composite material as per [0121]).
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 coating of Bluecher that comprises a composite into Fiebig for the purpose of providing “a solution for maintaining liminal patency while inducing potential for removability and reducing migration” as per [0014]. As such, the coating is taken to aid in keeping a stent in an expanded state in the body while preventing the stent from moving after it is set in place.
Claim(s) 210, 212 and 214 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fiebig (US Pub No.: 2020/0188080) in view Mauney (US Patent No.: 10,912,862) and Valimaa (US Patent No.: 6,709,452).
Regarding claim 210, Fiebig discloses a scaffold (scaffold for a sphincter assistance device in figure 15-17B as per [0066]) for inducing an inflammatory response (promotion of a growth of scar tissue in [0048]), the scaffold comprising: a matrix comprising a plurality of bioabsorbable filaments (PGA threads in a bioabsorbable scaffold in [0072] and [0063]), wherein the matrix is configured to independently reinforce the sphincter (reinforcement buttress in [0070] that is placed around the LES in [0071]. As per [0068] and figures 15 and 16A, part 426 reinforces the sphincter, where part 426 is part of part 416 that is part of a matrix (426 being in 416 in [0068])), wherein the matrix is configured to be disposed adjacent a sphincter within a patient, wherein the matrix is configured to fully bioabsorb adjacent to the sphincter patient (as the device is for a sphincter assistance with a placement by an exterior wall of an esophagus as per the abstract),
However, Fiebig does not disclose an instance wherein the matrix is composed a first plurality of filaments comprising a first material and a second plurality of filaments comprising a second material.
Instead, Mauney (US Patent No.: 10,912,862) teaches an instance wherein the matrix is composed a first plurality of filaments (in column 1 line 45 to column 2 line 2, a first and second layer of a matrix are present, where the matrix comprises filaments as per column 5 lines 32-47 as electrospun fibers and woven materials are disclosed here) comprising a first material and a second plurality of filaments comprising a second material (differing materials in column 1 line 45 to column 2 line 2). 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 Mauney into the device of Taylor and Fiebig for the purpose of providing a matrices that improve on a wound healing, as per column 1 lines 28-35.
However, Fiebig does not teach wherein the bioabsorbable filaments are configured to independently reinforce the sphincter or wherein an expected time for the first material to be bioabsorbed differs from an expected time for the second material to be bioabsorbed.
Instead Valimaa (US Patent No.: 6,709,452) teaches wherein the bioabsorbable filaments (in column 6 lines 9-40) are configured to independently reinforce the sphincter (fibers for reinforcement in column 6 lines 9-40, reinforcing of a sphincter in column 3 lines 12-29. While a urethra is disclosed in column 3 lines 12-29, a disclosure to supporting, connecting, or separating elongated organs is present in column 1 lines 14-21 makes this art analogous to Fiebig) or wherein an expected time for the first material to be bioabsorbed differs from an expected time for the second material to be bioabsorbed (disclosed in the abstract of Valimaa).
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 support fibers of Valimaa for the purpose of providing a rigid support filament into Fiebig that reinforces the sphincter to be treated in Fiebig (reinforcement in column 6 lines 9-40) and allows for the device to degrade and leave the body (as per column 1 lines 14-21) while the fibers of Valimaa have multiple rates of degradation as per the abstract of Valimaa.
Regarding claim 212, Fiebig in view of Mauney, Valimaa and Belcheva teach the scaffold of Claim 210, wherein Fiebig discloses the matrix is configured to induce an inflammatory response in the sphincter (second material 416 promotes scar tissue formation in [0068]).
Regarding claim 214, Fiebig in view of Mauney, Valimaa and Belcheva teach the scaffold of Claim 210, wherein the scaffold comprises a flat woven shape or a tubular shape (in Fiebig, the shape of the device is shown to be tubular in figures 2-3).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tarabien (US Pub No.: 2020/0138559) for a stent with multiple biodegradable materials as per the abstract. Jandrall (US Pub No.: 2007/0142699) for a device to treat GERD (in [0002]) with a placement by an esophageal sphincter in [0029].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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