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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/12/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/12/2026 have been fully considered but they are not persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
The combination does not require reconfiguring the implant of Murray. Bonutti is intended to teach an arthroscopic delivery device. It is not the intention of the Examiner to reconfigure the implant of Murray, but simply offer a known delivery device. Murray is silent with respect to details of the delivery device but points to the use of arthroscopic equipment (¶ [0072]). It would be obvious to use the Bonutti delivery device to deliver the implantable material of Murray as it is intended to be used for controlled arthroscopic delivery of a small implant.
Claim Status
The drawing objection has been overcome.
Claims 1-5, 8-18 and 21-27 are examined below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the guiding suture must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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) 1-5, 8-18 and 21-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Murray (US 2009/0306776 A1) in view of Bonutti (US 5,403,348 A).
Regarding claim 1, Murray teaches an arthroscopic repair system, comprising:
a tissue healing device (fig. 1B) configured to repair a ligament at a repair site (¶ [0001]), the tissue healing device having:
an implantable material (14, scaffold, fig. 1B) configured to be positioned between a ruptured end of the ligament and a bone (4, femur, fig. 1C),
at least one fixation device (8, anchor, fig. 1B) configured to be secured to the bone (¶ [0038]), wherein the at least one fixation device comprises an eyelet at a first end of the fixation device (10, eyelet, fig. 1B), and
at least one suture (12, suture, fig. 1B) configured to be threaded through or along the implantable material to position the implantable material between to the ruptured end of the ligament and the bone (¶ [0050], figs. 1B-1C), the at least one suture being attached to the at least one fixation device through the eyelet (¶ [0038], fig. 1B); and
arthroscopic equipment sized and shaped to contain the at least one suture and the implantable material (¶ [0073]).
Murray fails to teach an elongated delivery member and a plunger. However, Bonutti teaches an arthroscopic delivery device for the delivery of an implant that is slidably attached to a suture that includes arthroscopic equipment comprising an elongated delivery member (84, guide, fig. 5) and a plunger (82, pusher, fig. 5), the arthroscopic equipment further comprising a guiding suture (50, suture, fig. 5) extending from a distal end of the elongated delivery member of the plunger (fig. 7, the suture extends from the flanged distal end portion 94).
The phrase “a plunger configured to push the suture and the implantable material through the elongated delivery member and into the repair site such that the implantable material is positioned along the suture between the ruptured end of the ligament and the bone” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the pusher (82) is considered to be capable of pushing the suture and the implantable material through the elongated delivery member and into the repair site such that the implantable material is positioned along the suture between the ruptured end of the ligament and the bone. In this combination the suture would go through the drilled hole (20) of Murray as is typical of ligament repairs.
The phrase “a guiding suture . . . configured to pull and position the suture and the implantable material into the repair site” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the suture (50) is considered to be capable of pulling and positioning the suture and the implantable material into the repair site. In this combination the suture would go through the drilled hole (20) of Murray as is typical of ligament repairs.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the arthroscopic equipment of Murray to include an elongated delivery member and a plunger as taught by Bonutti in order to manipulate the implant (col 5, liens 14-18, Bonutti) and deliver the implant non-invasively. Further, Murray teaches the use of arthroscopic equipment (¶ [0072]), the delivery device of Bonutti is a known arthroscopic delivery device for bone and soft tissue and would be contemplated by someone of ordinary skill in the art.
Regarding claim 15, Murray teaches a system for repair of an anterior cruciate ligament comprising:
a fixation device (8, anchor, fig. 1B)comprising an eyelet at a first end of the fixation device (10, eyelet, fig. 1B), wherein the fixation device is capable of forming a stable attachment to a first bone at a repair site (4, femur, fig. 1C, ¶ [0038]);
a suture (12, suture, fig. 1B) having a first end (16, first end, fig. 2A) and a second end (18, second end, fig. 2A),wherein the suture is attachable to the fixation device through the eyelet (¶ [0047]), the second end being attachable to a ruptured end of the ligament at the repair site (¶ [0055]), wherein the ligament is configured to be connected to a second bone (6, tibia, fig. 1C);
a scaffold (14, scaffold, fig. 1B), wherein the scaffold consists essentially of a porous sponge scaffold (¶ [0045]), wherein the scaffold is threaded onto the suture (¶ [0050]).
Murray fails to teach an elongated delivery member and a plunger. However, Bonutti teaches an arthroscopic delivery device for the delivery of an implant that is slidably attached to a suture that includes an elongated delivery member (84, guide, fig. 5) having a channel (96, central channel, fig. 5) that extends from a proximal end (92, proximal end, fig. 5) to a distal end (94, distal end, fig. 5), the suture and scaffold contained within the channel such that the scaffold is positionable along the suture (fig. 5);
a plunger (82, pusher, fig. 5); and
a guiding suture (50, suture, fig. 5) extending from the distal end of the elongated delivery member (fig. 7).
The phrase “a plunger configured to push the suture and the scaffold through the channel of the elongated delivery member and into the repair site such that the scaffold is positioned along the suture between the ruptured end of the ligament and the first bone” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the pusher (82) is considered to be capable of pushing the suture and the scaffold through the channel of the elongated delivery member and into the repair site such that the scaffold is positioned along the suture between the ruptured end of the ligament and the first bone. In this combination the suture would go through the drilled hole (20) of Murray as is typical of ligament repairs.
The phrase “a guiding suture . . . configured to cooperate with the plunger to pull and position the suture and the scaffold into the repair site” is a functional recitation (see MPEP 2114.II). The prior art is not required to explicitly disclose the recited function, but merely have the capability of performing [or being manipulated to] the recited function in order to meet the claim requirements. In this case, the suture (50) is considered to be capable of cooperating with the plunger to pull and position the suture and the scaffold into the repair site (figs. 5-8). In this combination the suture would go through the drilled hole (20) of Murray as is typical of ligament repairs.
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filling date of the claimed invention to have modified the system of Murray to include an elongated delivery member, a plunger and guiding suture as taught by Bonutti in order to manipulate the implant (col 5, liens 14-18, Bonutti) and deliver the implant non-invasively. Further, Murray teaches the use of arthroscopic equipment (¶ [0072]), the delivery device of Bonutti is a known arthroscopic delivery device for bone and soft tissue and would be contemplated by someone of ordinary skill in the art.
Regarding claim 2, Murray further teaches the implantable material is a scaffold (14, scaffold, fig. 1B).
Regarding claim 3, Murray further teaches the ligament is an ACL (¶ [0012]) and wherein the implantable material allows cell ingrowth (¶ [0031] and ¶ [0044]).
Regarding claims 4 and 17, Murray further teaches the at least one fixation device is conical in shape (¶ [0047], fig. 1B).
Regarding claims 5 and 18, Murray further teaches the at least one fixation device includes a first end (see annotated fig. 1B, below) and a second end (see annotated fig. 1B, below) opposite the first end of the fixation device.
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Regarding claims 8 and 21, Murray further teaches the at least one fixation device includes a sharpened tip at the second end of the fixation device (¶ [0047]).
Regarding claims 9 and 22, Murray further teaches the sharpened tip is threaded (¶ [0047], grooves suitable for screwing).
Regarding claims 10 and 23, Murray further teaches the at least one fixation device is selected from the group consisting of a screw, a barb, a helical fixation device, a staple, a clip, a snap. and a rivet (¶ [0048]).
Regarding claims 11 and 24, Murray further teaches the implantable material further comprises a repair material (¶ [0065]).
Regarding claims 12 and 25, Murray further teaches the repair material is a platelet or plasma (¶ [0065]).
Regarding claims 13 and 26, Murray further teaches one or more growth factors configured to be disposed within or on the implantable material (¶ [0043]).
Regarding claims 14 and 27, Murray further teaches the implantable material consists essentially of a porous collagen sponge (¶ [0044] - ¶ [0045]).
Regarding claim 16, Murray further teaches the implantable material allows cell ingrowth (¶ [0044]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Clark (US 2005/0159748) teaches a syringe style delivery device.
Mayr (US 2009/0222090 A1) teaches a syringe style delivery device.
Stone (US 7,850,711 B1) teaches a syringe style delivery device.
Bonutti (US 5,948,002) teaches a syringe style delivery device.
Bolton (US 5,906,6332) teaches a syringe style delivery device.
Brown (US 2013/0123810 A1) teaches a syringe style delivery device.
Schmieding (US 2017/0027684 A1 teaches and elongated delivery member.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Tuesday and Thursday - Friday 7:30 am - 6:00 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JERRAH C 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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/T.M.D./Examiner, Art Unit 3774
/JERRAH EDWARDS/Supervisory Patent Examiner, Art Unit 3774
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