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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 and 15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Status
The 35 U.S.C. 112(a) rejection and the drawing objections for grayscale and no mention of figures 6A, figure 6B and figure 6C have been overcome.
Claims 1-5, 8-18 and 21-27 are examined below.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: 1 (repair device). 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. 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 a plunger and a guiding suture. However, Bonutti teaches a delivery device for an anchor that includes a plunger (82, pusher, fig. 5) and a guiding suture (50, suture, fig. 5) configured to pull and position the suture and the implantable material into the repair site (col 5 lines 14-55).
The phrase “configured to a) insert the suture through the implantable material” 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. Murray as modified above by Bonutti is considered to be capable of inserting the suture through the implantable material.
The phrase “configured to . . . b) position the implantable material 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. Murray as modified above by Bonutti is considered to be capable of positioning the implantable material between the ruptured end of the ligament and the bone.
In light of Bonutti’s teachings, one of ordinary skill in the art would have found it obvious to configure the delivery device of Murray to includes a plunger and a guiding suture in order to manipulate the anchor (col 5, lines 14-18, Bonutti).
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]); and
an elongated delivery member having a channel that extends from a proximal end to a distal end (¶ [0073], arthroscopic equipment), the suture and scaffold contained within the channel such that the scaffold is positionable along the suture. The phrase “the suture and scaffold contained within the channel such that the scaffold is positionable along the suture” 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 standard arthroscopic equipment is considered to be capable of containing the suture and the scaffold within the channel such that the scaffold is positionable along the suture.
Murray fails to teach a plunger and a guiding suture. However, Bonutti further teaches a plunger (82, pusher, fig. 5) configured to push the suture and the scaffold into the repair site (col 5, liens 14-18); and a guiding suture (50, suture, fig. 5) that extends out of the distal end of the elongated delivery member (58, suture proximal end, fig. 5), the guiding suture configured to pull and position the suture and the scaffold into the repair site (col 5 lines 14-55). In light of Bonutti’s teachings, one of ordinary skill in the art would have found it obvious to configure the system of Murray to includes a plunger and a guiding suture in order to manipulate the anchor (col 5, lines 14-18, Bonutti).
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.
PNG
media_image1.png
293
196
media_image1.png
Greyscale
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
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 TERESA M DUDDEN whose telephone number is (571)272-0435. The examiner can normally be reached Monday - Friday 7:30 am - 5:00 pm EST.
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, THOMAS BARRETT can be reached at (571) 272-4746. 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.
/T.M.D./Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799