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
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.
Claims 1-7, 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2017/0189164 to Zenz-Olson.
As to claim 1, Zenz-Olson discloses an implant delivery device (40), comprising a handle (“handle”, paragraph 67) disposed at a proximal end of the implant delivery device and configured to be grasped by a user, a first shaft (44) extending distally from the handle, and an implant holder (46, figure 6, paragraph 69; 146, figure 7, 8, paragraph 102) coupled to the first shaft, the implant holder being configured to retain a sheet-like implant (12; 112) adjacent two or more corners of the sheet-like implant during implantation of the sheet-like implant into a patient at a surgical site (figure 9a-c, 10). Either of the two frame body embodiments 46, 146 would be able to read on the implant holder as claimed deployable by the handle.
As to claim 2, Zenz-Olson discloses a second shaft (shaft extending from 90, figure 6, 12, paragraph 95-97) actuated by an actuator of the handle (paragraph 96, the means by which the user operates the device) to be movable along a cannula of the first shaft (paragraph 68, 140, 95-7, figure 6, 12, 18), wherein the second shaft is selectively engageable with and disengagement from the sheet-like implant (figure 18, paragraph 140). The shaft 44 has a lumen where the shaft extending from 90 will extend from, and will be actuated from the handle.
As to claim 3, Zenz-Olson discloses the implant holder includes a plurality of windows (60, 74, 70, 76) exposing portions of the sheet-like implant for implantation of suture anchors into the sheet-like implant (figure 4b, 5a-c). The scope of the claim is to an implant delivery device, not the system. Therefore the sheet-like implant and/or the suture anchor would be not be able to be positively claimed. The windows/holes/apertures will be able to expose portions of the implant to suture anchors.
As to claim 4, Zenz-Olson discloses the plurality of windows comprise at least two windows (70, 70, and/or 72, 72 figure 5a) including a first window adjacent to and inward of a first of the first two or more sheet corners and a second window adjacent to and inward of a second of the two or more corners. Of note, the implant is not interpreted to be positively claimed. The windows are capable of being adjacent to corners of the implant.
As to claim 5, Zenz-Olson discloses the two or more corners include at least a first distal corner and a second distal corner of the sheet like implant (figure 5a). Of note, the implant is not interpreted to be positively claimed. The corners are capable of being distal corners.
As to claim 6, Zenz-Olson discloses the implant holder is configured as sheet-like deformable card along portions thereof (figure 5a, paragraph 75, 76).
As to claim 7, Zenz-Olson discloses the portions include a plurality of outer edge portions of the card that define at least part of the plurality of windows and the portions of the card that define at least parts of the plurality of windows and the portions of the implant holder being configured to retain the sheet-like implant adjacent the two or more corners (figure 5a).
As to claim 9, Zenz-Olson discloses the implant holder is configured to capture the sheet-like implant with a plurality of slots (170, 170, paragraph 109-110) which receive the sheet-like implant therein adjacent the two or more corners of the sheet-like implant. The channels are configured to receive the implant and/or an extension from the implant. Since the implant is not positively claimed, the channels can read on the slots.
As to claim 10, Zenz-Olson discloses the implant holder is configured to pinch a first major side and a second major side of the sheet-like implant during capture of the sheet-like implant with the plurality of slots (paragraph 72, figure 9a). The frame can fold the implant and the slots can engage first and second major sides.
As to claim 11, Zenz-Olson discloses the plurality of slots are configured to facilitate disengagement of the sheet-like implant from the implant holder upon withdrawal of the implant holder generally proximally from the surgical site (figure 18, paragraph 103, 104, 109, 117). The frame is detachable from the implant and proximally withdrawn. The slots allow the attachment and detachment to the implant. Therefore the channels of Zenz-Olson can read on the claims of record.
As to claim 12, Zenz-Olson discloses the implant holder includes holes (the hole of 198 and/or detent 1763, figure 9b, or the channel ends in a hole-like element) at an end of each of the plurality of slots.
As to claim 13, Zenz-Olson discloses the implant holder is configured to maintain the sheet-like implant in a substantially flat position (figure 12, 14) adjacent a target tissue of the patient at the surgical site.
As to claim 14, Zenz-Olson discloses an implant delivery device (using a similar delivery system 40 to deliver the embodiment of 146), comprising a handle (“handle”, paragraph 67) disposed at a proximal end of the implant delivery device and configured to be grasped by a user, a first shaft (44) extending distally from the handle, and an implant holder (146, figure 7, 8, paragraph 102) coupled to the first shaft, the implant holder being configured to retain a sheet-like implant (12; 112) using a plurality of slots (170,170, figure 8, 9a-c, paragraph 109-111) which receive the sheet-like implant therein adjacent at least a first distal corner and a second distal corner of the sheet-like implant during implantation of the sheet-like implant during implantation of the sheet-like implant into a patient at a surgical site (figure 9a-c, 10). The scope of the claim is a delivery device and therefore the implant is not interpreted to be positively claimed. The channels engage with implant and/or at least with extensions of the implant. The channels can read on the slots since they do have a slot like structure and are able to engage an implant.
As to claim 15, Zenz-Olson discloses the implant holder is configured to pinch a first major side and a second major side of the sheet-like implant to retain the sheet-like implant with the plurality of slots paragraph 72, figure 9a). The frame can fold the implant and the slots can engage first and second major sides.
As to claim 16, Zenz-Olson discloses the plurality of slots are configured to facilitate disengagement of the sheet-like implant from the implant holder upon withdrawal of the implant holder generally proximally from the surgical site (figure 18, paragraph 103, 104, 109, 117). The frame is detachable from the implant and proximally withdrawn. The slots allow the attachment and detachment to the implant. Therefore the channels of Zenz-Olson can read on the claims of record.
As to claim 17, Zenz-Olson discloses the implant holder includes holes (the hole of 198 and/or detent 1763, figure 9b, or the channel ends in a hole-like element) at an end of each of the plurality of slots.
As to claim 18, Zenz-Olson discloses the implant holder is configured to maintain the sheet-like implant in a substantially flat position (figure 12, 14) adjacent a target tissue of the patient at the surgical site.
As to claim 19, Zenz-Olson discloses a second shaft (shaft extending from 190, in figure 10, similar to the shaft extending from 90 as seen in figure 6, 12, paragraph 95-97) actuated by an actuator of the handle (paragraph 96, the means by which the user operates the device) to be movable along a cannula of the first shaft (paragraph 68, 140, 95-7, figure 6, 12, 18), where the second shaft is selectively engageable with and disengagement from the sheet-like implant (figure 18, paragraph 140). The shaft 44 has a lumen where the shaft extending from 90 will extend from, and will be actuated from the handle.
As to claim 20, Zenz-Olson discloses the implant holder includes a plurality of windows (174, 174) exposing portions of the sheet-like implant for implantation of suture anchors into the sheet-like implant (figure 9a), wherein the plurality of windows comprise at least a first window adjacent to and inward of a first of the first two or more sheet corners and a second window adjacent to and inward of a second of the two or more corners (figure 9a, the apertures 174 can be adjacent and inward to sheet corners), wherein the implant holder is configured as a sheet-like deformable card along portions thereof (figure 9a, paragraph 75, 76), wherein the portions include a plurality of outer edge portions of the card that define at least part of the plurality of windows and the portions of the implant holder being configured to retain the sheet-like implant adjacent the first distal corner and the second distal corner (figure 5a). The scope of the claim is to an implant delivery device, not the system. Therefore the sheet-like implant and/or the suture anchor would be not be able to be positively claimed. The windows/holes/apertures will be able to expose portions of the implant to suture anchors.
Claims 1-7, 9-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 11,779,371 to Levy.
As to claim 1, Levy discloses an implant delivery device (100, figure 1), comprising a handle (102) disposed at a proximal end of the implant delivery device and configured to be grasped by a user, a first shaft (103) extending distally from the handle, and an implant holder (104, col. 12 ll. 61-63, figure 14-16) coupled to the first shaft, the implant holder being configured to retain a sheet-like implant (101) adjacent two or more corners of the sheet-like implant during implantation of the sheet-like implant into a patient at a surgical site (figure 16).
As to claim 2, Levy discloses a second shaft (1802, or the wire 303) actuated by an actuator of the handle (col. 13 ll. 2-24, col. 15 ll. 47-65, col. 20 ll. 67-col. 21 ll. 21 the actuation of the movement will be ultimately from the handle, figure 27-32) to be movable along a cannula of the first shaft (figure 5, 27-32), wherein the second shaft is selectively engageable with and disengagement from the sheet-like implant (figure 19, 20). The first shaft has a lumen and a second shaft, either 1802 or 303 will extend therethrough and can be actuated by the handle, similar to the backbone embodiment of figure 37-41, col. 31 ll. 46-51.
As to claim 3, Levy discloses the implant holder includes a plurality of windows (106, 106, figure 3) exposing portions of the sheet-like implant for implantation of suture anchors into the sheet-like implant (col. 14 ll. 29-38). The scope of the claim is to an implant delivery device, not the system. Therefore the sheet-like implant and/or the suture anchor would be not be able to be positively claimed. The windows/holes/apertures will be able to expose portions of the implant to suture anchors.
As to claim 4, Levy discloses the plurality of windows comprise at least two windows (106, 106, figure 2, 3) including a first window adjacent to and inward of a first of the first two or more sheet corners and a second window adjacent to and inward of a second of the two or more corners. Of note, the implant is not interpreted to be positively claimed. The windows are capable of being adjacent to corners of the implant.
As to claim 5, Levy discloses the two or more corners include at least a first distal corner and a second distal corner of the sheet like implant (figure 2, 3). Of note, the implant is not interpreted to be positively claimed. The corners are capable of being distal corners.
As to claim 6, Levy discloses the implant holder is configured as a sheet-like deformable card along portions thereof (figure 3, col. 13 ll. 2-24).
As to claim 7, Levy discloses the portions include a plurality of outer edge portions of the card that define at least part of the plurality of windows and the portions of the card that define at least parts of the plurality of windows and the portions of the implant holder being configured to retain the sheet-like implant adjacent the two or more corners (figure 6).
As to claim 9, Levy discloses the implant holder is configured to capture the sheet-like implant with a plurality of slots (105, 105, figure 1, 14, col. 13 ll. 5-10, the retainer can define the slots) which receive the sheet-like implant therein adjacent the two or more corners of the sheet-like implant. The retainers are configured to receive the implant. Since the implant is not positively claimed, the channels can read on the slots.
As to claim 10, Levy discloses the implant holder is configured to pinch a first major side and a second major side of the sheet-like implant during capture of the sheet-like implant with the plurality of slots (figure 7, 8). The plate can pinch the sides to assume the configuration as seen in figure 7.
As to claim 11, Levy discloses the plurality of slots are configured to facilitate disengagement of the sheet-like implant from the implant holder upon withdrawal of the implant holder generally proximally from the surgical site (figure 21-26). The plate is detachable from the implant and proximally withdrawn. The slots allow the attachment and detachment to the implant. Therefore the retainers of Levy can read on the claims of record.
As to claim 12, Levy discloses the implant holder includes holes (figure 6, 14) at an end of each of the plurality of slots. Without further limitations with respect to the holes, the plate has holes at which can read on the holes at ends of the slots.
As to claim 13, Levy discloses the implant holder is configured to maintain the sheet-like implant in a substantially flat position (figure 25) adjacent a target tissue of the patient at the surgical site.
As to claim 14, Levy discloses an implant delivery device (100), comprising a handle 102) disposed at a proximal end of the implant delivery device and configured to be grasped by a user, a first shaft (103) extending distally from the handle, and an implant holder (104) coupled to the first shaft, the implant holder being configured to retain a sheet-like implant (101) using a plurality of slots (105,105, figure 1, 14, col. 13 ll. 5-10 the retainers define the slots) which receive the sheet-like implant therein adjacent at least a first distal corner and a second distal corner of the sheet-like implant during implantation of the sheet-like implant during implantation of the sheet-like implant into a patient at a surgical site (figure 22-26). The scope of the claim is a delivery device and therefore the implant is not interpreted to be positively claimed.
As to claim 15, Levy discloses the implant holder is configured to pinch a first major side and a second major side of the sheet-like implant to retain the sheet-like implant with the plurality of slots (figure 7). The retainers are configured to pinch the implant to assume at least the shape of figure 7, and/or other configurations.
As to claim 16, Levy discloses the plurality of slots are configured to facilitate disengagement of the sheet-like implant from the implant holder upon withdrawal of the implant holder generally proximally from the surgical site (figure 21-26). The plate is detachable from the implant and proximally withdrawn. The slots allow the attachment and detachment to the implant. Therefore the retainers of Levy can read on the claims of record.
As to claim 17, Levy discloses the implant holder includes holes (figure 6, 14) at an end of each of the plurality of slots. Without further limitations with respect to the holes, the plate has holes at which can read on the holes at ends of the slots.
As to claim 18, Levy discloses the implant holder is configured to maintain the sheet-like implant in a substantially flat position (figure 25) adjacent a target tissue of the patient at the surgical site.
As to claim 19, Levy discloses a second shaft (1802, or the wire 303) actuated by an actuator of the handle (col. 13 ll. 2-24, col. 15 ll. 47-65, col. 20 ll. 67-col. 21 ll. 21 the actuation of the movement will be ultimately from the handle, figure 27-32) to be movable along a cannula of the first shaft (figure 5, 27-32), wherein the second shaft is selectively engageable with and disengagement from the sheet-like implant (figure 19, 20). The first shaft has a lumen and a second shaft, either 1802 or 303 will extend therethrough and can be actuated by the handle, similar to the backbone embodiment of figure 37-41, col. 31 ll. 46-51.
As to claim 20, Levy discloses the implant holder includes a plurality of windows (106, 106) exposing portions of the sheet-like implant for implantation of suture anchors into the sheet-like implant (figure 3), wherein the plurality of windows comprise at least a first window adjacent to and inward of a first of the first two or more sheet corners and a second window adjacent to and inward of a second of the two or more corners (figure 3, the holes 106 can be adjacent and inward to sheet corners), wherein the implant holder is configured as a sheet-like deformable card along portions thereof (figure 3), wherein the portions include a plurality of outer edge portions of the card that define at least part of the plurality of windows and the portions of the implant holder being configured to retain the sheet-like implant adjacent the first distal corner and the second distal corner (figure 3, 6, 16). The scope of the claim is to an implant delivery device, not the system. Therefore the sheet-like implant and/or the suture anchor would be not be able to be positively claimed. The holes will be able to expose portions of the implant to suture anchors.
Claim Rejections - 35 USC § 103
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2017/0189164 to Zenz-Olson in view of U.S. Patent Publication 2004/0019360 to Farnsworth.
As to claim 8, Zenz-Olson discloses the device above but is silent about the implant holder is made of thermoplastic polyester elastomer. Zenz-Olson does disclose the device can made from a variety of polymeric materials (paragraph 76). Farnsworth teaches a similar device (implantable tissue repair, abstract) that a support member can be made from a thermoplastic polyester elastomer (paragraph 41) for the purpose of using suitable materials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the implant holder of Zenz-Olson be made of thermoplastic polyester elastomer since it has been to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 11,779,371 to Levy in view of U.S. Patent Publication 2004/0019360 to Farnsworth.
As to claim 8, Levy discloses the device above but is silent about the implant holder is made of thermoplastic polyester elastomer. Levy does disclose the device can made from a plastic material that has a bias (col. 12 ll. 24-25). Farnsworth teaches a similar device (implantable tissue repair, abstract) that a support member can be made from a thermoplastic polyester elastomer (paragraph 41) for the purpose of using suitable materials. It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have the implant holder of Levy be made of thermoplastic polyester elastomer since it has been to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 3,422,817 to Mishkin, U.S. Patent 5,370,650 to Tovey, U.S. Patent 5,656,012 to Sienkiewicz, U.S. Patent Publication 2007/0088189 to Levy, U.S. Patent Publication 2009/0012521 to Axelson, U.S. Patent Publication 2010/0318121 to Levin, U.S. Patent Publication 2011/0040310 to Levin, U.S. Patent Publication 2012/0259347 to Abuzaina, U.S. Patent Publication 2013/0035704 to Dudai, U.S. Patent Publication 2017/0172720 to Schwartz, U.S. Patent Publication 2018/0221126 to Igov, and U.S. Patent Publication 2018/0221127 to Richard all disclose similar devices capable of disclosing, rendering obvious, and/or providing evidence on the claims of record.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771
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