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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of group I, claims 1-9 and Figs. 4, 9-13 and 15-18 in the reply filed on 12/19/2025 is acknowledged. Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Thus, claims 1-9 are presently pending in this application.
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.
Claims 1-7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Felix et al. (2017/0181830) “Felix” in view of Euteneuer et al. (2011/0004221) “Euteneuer”
Regarding claims 1-6, Felix discloses an implant 34 (Fig. 1) delivery system 50 (Fig. 4), the implant delivery system comprising: a delivery shaft 54 including a proximal portion and a distal portion (top and bottom portions of delivery shaft 54; Fig. 4); and a detachable frame 52 (Fig. 4 and Fig. 6A discloses the frame 52 is detachable from shaft 54) coupled to the distal portion of the delivery shaft (Fig. 4), wherein the detachable frame includes a body portion 52; except for the detachable frame includes a plurality of attachment arms extending away from the body portion; wherein the body portion further includes a first support strut positioned adjacent to a second support strut, and wherein the first support strut converges with the second support strut at a first convergence region, and wherein a first attachment arm of the plurality of attachment arms extends away from the first convergence region; wherein the first support strut and the second support strut are arranged in a substantially triangular geometry; wherein the body portion further includes a third support strut positioned adjacent to a fourth support strut, and wherein the third support strut converges with the fourth support strut at a second convergence region, and wherein a second attachment arm of the plurality of attachment arms extends away from the second convergence region; wherein the second support strut converges with the fourth support strut; wherein the first attachment arm and the second attachment arm extend away from one another; and wherein the plurality of attachment arms are configured to be attached to an implant.
However, Euteneuer teaches a similar implant 50 delivery system 60 (Fig. 9) comprising a frame 120 (Fig. 7) including a plurality of attachment arms extending away from the body portion (the body of the frame 120); wherein the body portion further includes a first support strut positioned adjacent to a second support strut, and wherein the first support strut converges with the second support strut at a first convergence region, and wherein a first attachment arm of the plurality of attachment arms extends away from the first convergence region; wherein the first support strut and the second support strut are arranged in a substantially triangular geometry; wherein the body portion further includes a third support strut positioned adjacent to a fourth support strut, and wherein the third support strut converges with the fourth support strut at a second convergence region, and wherein a second attachment arm of the plurality of attachment arms extends away from the second convergence region; wherein the second support strut converges with the fourth support strut; wherein the first attachment arm and the second attachment arm extend away from one another and wherein the plurality of attachment arms are configured to be attached to an implant 50 (Fig. 10C; see annotated Fig. 11 below).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the frame in Felix to include a plurality of attachment arms extending away from the body portion; wherein the body portion further includes a first support strut positioned adjacent to a second support strut, and wherein the first support strut converges with the second support strut at a first convergence region, and wherein a first attachment arm of the plurality of attachment arms extends away from the first convergence region; wherein the first support strut and the second support strut are arranged in a substantially triangular geometry; wherein the body portion further includes a third support strut positioned adjacent to a fourth support strut, and wherein the third support strut converges with the fourth support strut at a second convergence region, and wherein a second attachment arm of the plurality of attachment arms extends away from the second convergence region; wherein the second support strut converges with the fourth support strut; wherein the first attachment arm and the second attachment arm extend away from one another; and wherein the plurality of attachment arms are configured to be attached to an implant, as taught and suggested by Euteneuer, for sufficiently expanding and holding the implant at the surface of the target tissue (par. 0058).
Regarding claim 7, Felix further discloses a connection assembly coupled to the delivery shaft (Fig. 6A), the connection assembly including: a tack member 80 attached to a tack disk 88, wherein the tack disk is further attached to a collar 84; and wherein the collar is configured to extend into and engage the distal portion of the delivery shaft (Fig. 6B).
Regarding claim 9, Felix discloses the claimed invention of claim 1; except for a handle attached to the proximal portion of the delivery shaft; and a tether secured to the frame and extending proximally through a lumen of the delivery shaft to the handle; wherein the handle further includes a tether clamp configured to lock the tether to the handle. However, Euteneuer teaches a similar implant delivery system 60 (Fig. 9) comprising a handle 104 attached to the proximal portion of a delivery shaft 102; and a tether 130 secured to a frame 120and extending proximally through a lumen of the delivery shaft to the handle; wherein the handle further includes a tether clamp 134 configured to lock the tether to the handle (Fig. 9, the structure of the delivery system if fully capable of performing this intended use).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the implant delivery system in Felix to include a handle attached to the proximal portion of the delivery shaft; and a tether secured to the frame and extending proximally through a lumen of the delivery shaft to the handle; wherein the handle further includes a tether clamp configured to lock the tether to the handle, as taught and suggested by Euteneuer, for facilitating the ease of implantation of the sheet implant at the target tissue.
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Allowable Subject Matter
Claim 8 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the subject matter is allowable due to the limitations of “wherein the detachable frame includes a plurality of connector legs, wherein at least one the plurality of connector legs is disposed between the tack disk and the collar” as set forth in claim 8, which has not been found anticipated by or obvious over prior art. The closest prior art of record fails to disclose connector legs disposed in between the tack disk and the collar.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASHITA SHARMA whose telephone number is (571)270-5417. The examiner can normally be reached on 8am-5pm M-Th; 8am-4pm Fri (MT).
If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Jerrah 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.
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/YASHITA SHARMA/
Primary Examiner, Art Unit 3774