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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-10 and 13-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20050033363 (Bojarski).
1. Bojarski discloses a system (FIG. 3) for intracorporeal delivery of a fastener assembly (Abstract; FIG. 19A-19D and 28-30). The system comprising a needle assembly (sheath 200 and needle 100 of FIG. 3), a first T-fastener (fixation member 16), a second T-fastener (fixation member 18), a suture (suture 10), and a plunger (push rod 170). The needle assembly including a hub (handle 180) for single-handed operation by a clinician and a cannula (sheath 200) coupled at a proximal section to the hub (FIG. 3; P0209). The cannula having a distal section for minimally invasive delivery to a treatment site (FIG. 3; P0205). The cannula defining a lumen (lumen 202 of sheath or combination of lumen 202 of sheath and lumen 104 of needle 100) extending from the proximal section to the distal section (FIG. 3; P0205). The first T-fastener having a first elongate body (FIG. 2I and 4). The first T-fastener disposed within the lumen and having a first longitudinal axis aligned to an axis of the lumen (FIG. 3; P0205). The second T-fastener having a second elongate body (FIG. 2I and 4). The second T-fastener disposed within the lumen and having a second longitudinal axis aligned to the axis of the lumen and the first longitudinal axis of the first T-fastener (FIG. 3; P0205). The second T-fastener closer to the hub than the first T-fastener along the axis of the lumen (FIG. 3). The first T-fastener and the second T-fastener are formed of a bioabsorbable material (P0384; also see P0325 and P0336). The suture having a first end portion (e.g., end of suture 10 near handle 180 in FIG. 3), a second end portion (e.g., end of suture 10 near fixation member 16 in FIG. 3), and a length therebetween (FIG. 2I). At least a portion of the length is disposed in the lumen and extending through a first plurality of openings (holes 16A, 16B) in the first T-fastener and a second plurality of openings (holes 18A, 18B) in the second T-fastener (FIG. 2I and 3-4; P0203 and P0205). Tension applied to the suture causes the first T-fastener and the second T-fastener to pivot toward coaxial alignment with one another (FIG. 19A-19D; P0249-P0251), whereby the first T-fastener and the second T-fastener are positionable (or at least capable of being positioned) relative to one another with the suture to secure two layers of biological tissue in apposition therebetween (e.g., see FIG. 28-30 with two layers of tissue in apposition between retainers 1813, 1814 where the fixation members 16, 18 are fully capable of use in this manner). The plunger operable from the hub to separately and sequentially deploy the first T-fastener and the second T-fastener beyond the distal section of the cannula at the treatment site (FIG. 19A-19D; P0223 and P0249-P0251). The first plurality of openings in the first T-fastener define a first plane (e.g., transverse plane in FIG. 19A) substantially perpendicular to the first longitudinal axis of the first T-fastener (FIG. 19A) to permit the first T-fastener to pivot after deployment to the treatment site from a first alignment with the lumen of the cannula (FIG. 19A) to a second alignment self-aligned to biological tissue at the treatment site (FIG. 19B). The plurality of second openings in the second T-fastener define a second plane (e.g., transverse plane in FIG. 19A) substantially perpendicular to the second longitudinal axis of the second T-fastener (FIG. 19A) to permit the second T-fastener to pivot after deployment from the cannula to an alignment with the first T-fastener (FIG. 19D or 30).
2. Bojarski discloses a fastener assembly (FIG. 3) for intracorporeal tissue apposition (Abstract; FIG. 19A-19D and 28-30). The fastener assembly comprising a first T-fastener (fixation member 16), a second T-fastener (fixation member 18), and a suture (suture 10). The first T-fastener having a first longitudinal axis along a first elongate body (FIG. 2I and 4). The first elongate body defining a plurality of first openings (holes 16A, 16B). The second T-fastener having a second elongate body (FIG. 2I and 4) defining a plurality of second openings (holes 18A, 18B). The first T-fastener and the second T-fastener are formed of a bioabsorbable material (P0384; also see P0325 and P0336). The suture having a first end portion (e.g., end of suture 10 near handle 180 in FIG. 3), a second end portion (e.g., end of suture 10 near fixation member 16 in FIG. 3), and a length therebetween (FIG. 2I). The length extending through the first plurality of openings and the second plurality of openings (FIG. 2I and 3-4; P0203 and P0205) with the second T-fastener, along the length of the suture, between the first T-fastener and each of the first end portion and the second end portion of the suture (FIG. 2I and 3-4). The plurality of first openings in the first T-fastener define a first plane (e.g., transverse plane in FIG. 19A) substantially perpendicular to the first longitudinal axis of the first elongate body of the first T-fastener (FIG. 19A) to permit the first T-fastener to pivot after deployment to a treatment site from a first alignment for passing through a biological tissue at the treatment site (FIG. 19A) to a second alignment self-aligned to a surface of the biological tissue at the treatment site (FIG. 19B). Tension applied to the suture causes the first T-fastener and the second T-fastener to pivot toward coaxial alignment with one another (FIG. 19A-19D; P0249-P0251), whereby the first T-fastener and the second T-fastener are positionable (or at least capable of being positioned) relative to one another with the suture to secure two layers of biological tissue in apposition therebetween (e.g., see FIG. 28-30 with two layers of tissue in apposition between retainers 1813, 1814 where the fixation members 16, 18 are fully capable of use in this manner).
3. The second T-fastener is movable along the length of the suture in a direction toward the first T-fastener (FIG. 19B-19D and 28-30; P0250-P0251 and P0274 and P0278).
4. The first T-fastener is secured in a fixed position along the length of the suture (e.g., after slip knots are secured)(FIG. 19B-19D and 28-30; P0250-P0251 and P0274 and P0278).
5. The suture is bioabsorbable (P0384).
6. Each first opening of the plurality of first openings defines a respective first center axis, each second opening of the plurality of second openings defines a respective second center axis (FIG. 19A). With tension in the length of the suture, each first center axis associated with the plurality of first openings of the first T-fastener is movable into substantial coaxial alignment with a respective second center axis associated with the plurality of second openings of the second T-fastener (FIG. 30; P0274 and P0278).
7. Each first center axis defined by the plurality of first openings are substantially parallel to one another and spaced relative to one another by a first distance (FIG. 19A; P0203). Each second center axis defined by the plurality of second openings are substantially parallel to one another and spaced relative to one another by a second distance about equal to the first distance (FIG. 19A; P0203).
8. The plurality of second openings in the second T-fastener define a second plane (e.g., transverse plane in FIG. 19A) substantially perpendicular to a second longitudinal axis of the second elongate body of the second T-fastener to permit the second T-fastener to pivot after deployment to an alignment with the first T-fastener (FIG. 19D and 30).
9. The first T-fastener can pivot under a tension in the length of the suture about a point of intersection between alignment with the first longitudinal axis of the first elongate body and the first plane substantially perpendicular to the first longitudinal axis (FIG. 19D and 30; P0274 and P0278).
10. The second elongate body of the second T-fastener has a maximum radial dimension along the second plane and, in each direction away from the second plane along the second longitudinal axis, the second elongate body of the second T-fastener has a decreasing radial dimension (FIG. 19A and 15A).
13. Bojarski discloses a system (FIG. 3) for intracorporeal delivery of a fastener assembly (Abstract; FIG. 19A-19D and 28-30). The system comprising a first T-fastener (fixation member 16), a second T-fastener (fixation member 18), a suture (suture 10), and a needle assembly (sheath 200 and needle 100 of FIG. 3). The first T-fastener having a first elongate body defining a first longitudinal axis (FIG. 2I and 4). The second T-fastener having a second elongate body (FIG. 2I and 4). The first T-fastener and the second T-fastener are formed of a bioabsorbable material (P0384; also see P0325 and P0336). The suture having a first end portion (e.g., end of suture 10 near handle 180 in FIG. 3), a second end portion (e.g., end of suture 10 near fixation member 16 in FIG. 3), and a length therebetween (FIG. 2I). The length extending through a plurality of first openings (holes 16A, 16B) defined by the first elongate body and through a plurality of second openings (holes 18A, 18B) defined by the second elongate body (FIG. 2I and 3-4; P0203 and P0205). Tension applied to the suture causes the first T-fastener and the second T-fastener to pivot toward coaxial alignment with one another (FIG. 19A-19D; P0249-P0251), whereby the first T-fastener and the second T-fastener are positionable (or at least capable of being positioned) relative to one another with the suture to secure two layers of biological tissue in apposition therebetween (e.g., see FIG. 28-30 with two layers of tissue in apposition between retainers 1813, 1814 where the fixation members 16, 18 are fully capable of use in this manner). The needle assembly including a hub (handle 180) and a cannula (sheath 200; combination of sheath 200 and needle 100) (FIG. 3; P0209). The cannula having a proximal section and a distal section (FIG. 3; P0205). The hub coupled to proximal section of the cannula (FIG. 3; P0209). The cannula defining a lumen (lumen 202 of sheath or combination of lumen 202 of sheath and lumen 104 of needle 100) extending from the proximal section to the distal section (FIG. 3; P0205). Each of the first T-fastener, the second T-fastener, and at least a portion of the length of the suture disposed in the lumen (FIG. 3). The plurality of first openings in the first T-fastener define a first plane (e.g., transverse plane in FIG. 19A) substantially perpendicular to the first longitudinal axis of the first elongate body of the first T-fastener (FIG. 19A) to permit the first T-fastener to pivot after deployment to a treatment site from a first alignment for passing through a biological tissue at the treatment site (FIG. 19A) to a second alignment self-aligned to a surface of the biological tissue at the treatment site (FIG. 19B).
14. The second elongate body defines a second longitudinal axis (FIG. 19A). The cannula defines a cannula center axis substantially aligned with the first longitudinal axis and the second longitudinal axis (FIG. 19A).
15. With the second longitudinal axis of the second T-fastener substantially aligned with the cannula center axis in the lumen (FIG. 19A), the first T-fastener is positionable beyond the distal section of the cannula with the first longitudinal axis of the first T-fastener intersecting the second longitudinal axis of the second T-fastener (FIG. 19B; P0250).
16. The first end portion and the second end portion of the suture are disposed outside of the needle assembly (FIG. 3).
17. The cannula (at least needle 100) defines a slit (slot 110) extending from the proximal section to the distal section (FIG. 4; P0205). The slit has a cross-sectional dimension larger than a radial dimension of the suture (FIG. 4; P0205). The length of the suture extends through the slit with the first end portion and the second end portion of the suture outside of the cannula (FIG. 3).
18. The system has a plunger (push rod 170) in contact with the second T-fastener (FIG. 3; P0209). The plunger is depressible in a first discrete movement in a distal direction in the cannula, and the first discrete movement of the plunger in the distal direction moves the first T-fastener, the second T-fastener, and at least a portion of the length of the suture in the distal direction along the lumen (FIG. 3 and 19A-19B; P0209).
19. The plunger is depressible in a second discrete movement in the distal direction in the cannula, the first discrete movement of the plunger in the distal direction delivering the first T-fastener from the distal section of the cannula (FIG. 3 and 19C; P0209). The second discrete movement of the plunger in the distal direction delivering the second T-fastener from the distal section of the cannula (FIG. 3 and 19C; P0209).
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.
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) 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 20050033363 (Bojarski), as applied above, and further in view of US 2016/0242761 (Lore).
Bojarski discloses the invention substantially as claimed as discussed above but does not disclose the first T-fastener having a pair of grooves. Lore teaches a fastener assembly in the same field of endeavor having a first T-fastener with a pair of grooves (recesses 50) for the purpose of fixing the suture relative to the T-fastener within the recesses (FIG. 3A-3C; P0094). The grooves extending longitudinally along a longitudinal dimension of the first elongate body (FIG. 3A; P0094). A portion of the length of the suture is positionable in the pair of elongate grooves (FIG. 3A; P0094). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first T-fastener of Bojarski to have grooves as taught by Lore in order to fix the suture relative to the T-fastener within the grooves.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 20050033363 (Bojarski), as applied above, and further in view of US 9,414,824 (Fortson).
Bojarski discloses the invention substantially as claimed as discussed above but does not disclose the suture having a plurality of barbs. Fortson teaches a fastener assembly in the same field of endeavor having a suture with a plurality of barbs (FIG. 1; col. 5, lns. 23-43) for the purpose of allowing one-way movement of the second T-fastener along the suture (FIG. 1; col. 5, lns. 23-43). Each barb of the plurality of barbs extends radially from the length of the suture, and at least one of the first end portion of the suture or the second end portion of the suture is movable through the plurality of second openings of the second T-fastener in a first direction to move at least one barb of the plurality of barbs through at least one opening of the plurality of second openings (FIG. 1; col. 5, lns. 23-43). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the suture of Bojarski to include barbs as taught by Fortson in order to allow one-way movement of the second T-fastener along the suture.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over US 20050033363 (Bojarski), as applied above, and further in view of US 2015/0223803 (Trawick).
Bojarski discloses the invention substantially as claimed as discussed above but does not disclose the plunger being movable in a proximal direction in the cannula between the first discrete movement and the second discrete movement. Trawick teaches a system in the same field of endeavor having a plunger (first push rod 168) that is moveable in a proximal direction in the cannula between the first discrete movement and the second discrete movement (FIG. 3A-3D; P0061) for the purpose of deploying the first fastener with the first discrete movement and loading the second fastener for deployment after the plunger has been moved out of the way with the proximal direction movement (FIG. 3A-3D; P0061). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the plunger of Bojarski to be movable in the proximal direction as taught by Trawick in order to load the second fastener for deployment after the plunger has been moved out of the way with the proximal direction movement.
Response to Arguments
Applicant’s arguments regarding the new limitations have been considered but are moot because the arguments do not apply to the rejection in the previous office action (e.g., do not apply to claim limitations previously rejected). All arguments directed to new limitations in the amended claims are addressed in the rejection above.
Conclusion
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 TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights