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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2026 has been entered.
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) 1-11 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0038267 (Allen) in view of US 2016/0242761 (Lore).
1. Allen discloses a system (tool 200) for intracorporeal delivery of a fastener assembly (P0002 and P0011). The system comprising a needle assembly (e.g., combination of needle portion 204 and handle portion 202), a first T-fastener (anchor 16), a second T-fastener (anchor 14), a suture (member 30), and a plunger (e.g., “wire, rod or like member” at P0080).
The needle assembly including a hub (handle portion 202) for single-handed operation by a clinician and a cannula (needle portion 204) coupled at a proximal section to the hub (FIG. 27-30; P0079). The cannula having a distal section for minimally invasive delivery to a treatment site (FIG. 29; P0010). The cannula defining a lumen (lumen needle portion 204) extending from the proximal section to the distal section (FIG. 31-33; P0079-P0080). The first T-fastener having a first elongate body (FIG. 4). The first T-fastener disposed within the lumen and having a first longitudinal axis aligned to an axis of the lumen (FIG. 31-33; P0079-P0080). The second T-fastener having a second elongate body (FIG. 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. 31-33; P0079-P0080)(also see “The suture or like extension member is adapted to string or thread through the respective apertures of a series or array of such anchors. The array of anchors can be inserted within and along the interior lumen of a needle, cannula or like inserter or delivery tool for deployment.” at P0018). The second T-fastener closer to the hub than the first T-fastener along the axis of the lumen (FIG. 31-33; P0018). The suture having a first end portion (length 38a), a second end portion (length 38b), and a length therebetween (loops 30a, 30b)(FIG. 4; P0047 and P0056). At least a portion of the length is disposed in the lumen and extending through a first plurality of openings (apertures 16c) in the first T-fastener and a second plurality of openings (apertures 15a, 15b) in the second T-fastener (FIG. 4-7; P0057 and P0072). The suture is threaded through the first plurality of openings and the second plurality of openings such that the second T-fastener, along the length of the suture, is between the first T-fastener and each of the first end portion and the second end portion (FIG. 4-7; P0057 and P0072). Tension applied to the suture causes the first T-fastener and the second T-fastener to pivot toward coaxial alignment with one another (FIG. 31-33; P0085-P0089), 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 (FIG. 31-33; P0085-P0089). 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. 31-33; P0085-P0089). The first plurality of openings in the first T-fastener define a first plane (e.g., transverse plane in FIG. 4-5) substantially perpendicular to the first longitudinal axis of the first T-fastener (FIG. 4-5) 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. 31-33; P0018 and P0085-P0089) to a second alignment self-aligned to biological tissue at the treatment site (FIG. 4-5; P0085-P0089). The plurality of second openings in the second T-fastener define a second plane (e.g., transverse plane in FIG. 4-5) substantially perpendicular to the second longitudinal axis of the second T-fastener (FIG. 31-33; P0018 and P0085-P0089) to permit the second T-fastener to pivot after deployment from the cannula to an alignment with the first T-fastener (FIG. 4-5; P0018 and P0085-P0089).
Allen discloses the invention substantially as claimed as discussed above and further discloses the first and second T-fasteners and suture being PEEK, nylon, polycarbonate or polypropylene (P0076). Examiner notes that various polycarbonate materials exist that are bioabsorbable. However, Allen does not explicitly recite the T-fasteners and suture being a bioabsorbable material. Lore teaches a system in the same field of endeavor having T-fasteners and suture that are bioabsorbable (P0062 and P0094) in order to provide non-permanent materials (P0062 and P0094) and as an equivalent of non-bioabsorbable materials (P0062 and P0094). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the bioabsorbable T-fasteners and suture as taught by Lore in place of the non-bioabsorbable materials in order to provide non-permanent materials and since Lore teaches the materials as being equivalents such that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results to one of ordinary skill in the art (MPEP 2143).
2. Allen discloses a fastener assembly (tool 200) for intracorporeal tissue apposition (P0002 and P0011). The fastener assembly comprising a first T-fastener (anchor 16), a second T-fastener (anchor 14), and a suture (member 30).
The first T-fastener having a first longitudinal axis along a first elongate body (FIG. 4). The first T-fastener having a first longitudinal axis along a first elongate body (FIG. 4). The first elongate body defining a plurality of first openings (apertures 16c)(FIG. 4-7; P0057 and P0072). The second T-fastener having a second elongate body (FIG. 4) defining a plurality of second openings (apertures 15a, 15b)(FIG. 4-7; P0057 and P0072). The suture having a first end portion (length 38a), a second end portion (length 38b), and a length therebetween (loops 30a, 30b)(FIG. 4; P0047 and P0056). The length extending through the first plurality of openings and the second plurality of openings (FIG. 4; P0047 and P0056) 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. 4-7; P0057 and P0072). The plurality of first openings in the first T-fastener define a first plane (e.g., transverse plane in FIG. 4-5) substantially perpendicular to the first longitudinal axis of the first T-fastener (FIG. 4-5) 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. 31-33; P0018 and P0085-P0089) to a second alignment self-aligned to a surface of the biological tissue at the treatment site (FIG. 4-5; P0085-P0089). Tension applied to the suture causes the first T-fastener and the second T-fastener to pivot toward coaxial alignment with one another (FIG. 31-33; P0085-P0089), 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 (FIG. 31-33; P0085-P0089).
Allen discloses the invention substantially as claimed as discussed above and further discloses the first and second T-fasteners and suture being PEEK, nylon, polycarbonate or polypropylene (P0076). Examiner notes that various polycarbonate materials exist that are bioabsorbable. However, Allen does not explicitly recite the T-fasteners and suture being a bioabsorbable material. Lore teaches a system in the same field of endeavor having T-fasteners and suture that are bioabsorbable (P0062 and P0094) in order to provide non-permanent materials (P0062 and P0094) and as an equivalent of non-bioabsorbable materials (P0062 and P0094). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the bioabsorbable T-fasteners and suture as taught by Lore in place of the non-bioabsorbable materials in order to provide non-permanent materials and since Lore teaches the materials as being equivalents such that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results to one of ordinary skill in the art (MPEP 2143).
3. The second T-fastener is movable along the length of the suture in a direction toward the first T-fastener (FIG. 31-33; P0085-P0089).
4. The first T-fastener is secured in a fixed position along the length of the suture (e.g., “self-locking” at P0056).
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. 4-7; P0056-P0057 and P0072). 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. 4-7; P0056-P0057 and P0072).
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. 4-7; P0057 and P0072). 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 (e.g., relative term as shown in FIG. 4-7) to the first distance (FIG. 4-7; P0057 and P0072).
8. The plurality of second openings in the second T-fastener define a second plane (e.g., transverse plane in FIG. 4-5) 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. 31-33; P0018 and P0085-P0089).
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. 31-33; P0085-P0089).
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. 4-5).
11. Allen 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 Allen to have grooves as taught by Lore in order to fix the suture relative to the T-fastener within the grooves.
13. Allen discloses a system (tool 200) for intracorporeal delivery of a fastener assembly (P0002 and P0011). The system comprising a needle assembly (e.g., combination of needle portion 204 and handle portion 202), a first T-fastener (anchor 16), a second T-fastener (anchor 14), and a suture (member 30).
The needle assembly including a hub (handle portion 202) and a cannula (needle portion 204) coupled at a proximal section to the hub (FIG. 27-30; P0079). The cannula having a distal section for minimally invasive delivery to a treatment site (FIG. 29; P0010). The cannula defining a lumen (lumen needle portion 204) extending from the proximal section to the distal section (FIG. 31-33; P0079-P0080). The first T-fastener having a first elongate body (FIG. 4). The first T-fastener disposed within the lumen and having a first longitudinal axis aligned to an axis of the lumen (FIG. 31-33; P0079-P0080). The second T-fastener having a second elongate body (FIG. 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. 31-33; P0079-P0080)(also see “The suture or like extension member is adapted to string or thread through the respective apertures of a series or array of such anchors. The array of anchors can be inserted within and along the interior lumen of a needle, cannula or like inserter or delivery tool for deployment.” at P0018). 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. 31-33; P0018 and P0085-P0089). The suture having a first end portion (length 38a), a second end portion (length 38b), and a length therebetween (loops 30a, 30b)(FIG. 4; P0047 and P0056). At least a portion of the length is disposed in the lumen and extending through a first plurality of openings (apertures 16c) in the first T-fastener and a second plurality of openings (apertures 15a, 15b) in the second T-fastener (FIG. 4-7; P0057 and P0072). The suture is threaded through the first plurality of openings and the second plurality of openings such that the second T-fastener, along the length of the suture, is between the first T-fastener and each of the first end portion and the second end portion (FIG. 4-7; P0057 and P0072). Tension applied to the suture causes the first T-fastener and the second T-fastener to pivot toward coaxial alignment with one another (FIG. 31-33; P0085-P0089), 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 (FIG. 31-33; P0085-P0089). 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. 31-33; P0085-P0089). The first plurality of openings in the first T-fastener define a first plane (e.g., transverse plane in FIG. 4-5) substantially perpendicular to the first longitudinal axis of the first T-fastener (FIG. 4-5) 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. 31-33; P0018 and P0085-P0089) to a second alignment self-aligned to biological tissue at the treatment site (FIG. 4-5; P0085-P0089).
Allen discloses the invention substantially as claimed as discussed above and further discloses the first and second T-fasteners and suture being PEEK, nylon, polycarbonate or polypropylene (P0076). Examiner notes that various polycarbonate materials exist that are bioabsorbable. However, Allen does not explicitly recite the T-fasteners and suture being a bioabsorbable material. Lore teaches a system in the same field of endeavor having T-fasteners and suture that are bioabsorbable (P0062 and P0094) in order to provide non-permanent materials (P0062 and P0094) and as an equivalent of non-bioabsorbable materials (P0062 and P0094). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the bioabsorbable T-fasteners and suture as taught by Lore in place of the non-bioabsorbable materials in order to provide non-permanent materials and since Lore teaches the materials as being equivalents such that one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yields nothing more than predictable results to one of ordinary skill in the art (MPEP 2143).
14. The second elongate body defines a second longitudinal axis (FIG. 4-5). The cannula defines a cannula center axis substantially aligned with the first longitudinal axis and the second longitudinal axis (FIG. 31-33; P0018 and P0085-P0089).
15. With the second longitudinal axis of the second T-fastener substantially aligned with the cannula center axis in the lumen (FIG. 31-33; P0018 and P0085-P0089), 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. 31-33; P0018 and P0085-P0089).
16. The first end portion and the second end portion of the suture are disposed outside of the needle assembly (FIG. 31-33).
17. The cannula defines a slit (slot 110) extending from the proximal section to the distal section (FIG. 31-33; P0079-P0080). The slit has a cross-sectional dimension larger than a radial dimension of the suture (FIG. 31-33; P0079-P0080). 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. 31-33; P0079-P0080).
18. The system has a plunger (e.g., “wire, rod or like member” at P0080) in contact with the second T-fastener (FIG. 31-P0033; P0018 and P0085-P0089). 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. 31-P0033; P0018 and P0085-P0089).
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. 31-P0033; P0018 and P0085-P0089). The second discrete movement of the plunger in the distal direction delivering the second T-fastener from the distal section of the cannula (FIG. 31-P0033; P0018 and P0085-P0089).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 2016/0038267 (Allen) in view of US 2016/0242761 (Lore), as applied above, and further in view of US 9,414,824 (Fortson).
Allen 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 Allen 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 2016/0038267 (Allen) in view of US 2016/0242761 (Lore), as applied above, and further in view of US 2015/0223803 (Trawick).
Allen 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 Allen 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
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.
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.
TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights