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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “38” has been used in the specification and in the figures (See Figs. 2A-2B) to designate both the outer shaft of the driver tool and the proximal ends of the flexible member. Additionally, reference character “46” has been used in the specification and in the figures (See Figs. 3A & 4) to designate both the inserter tool and the fibular plate. 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 § 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.
Claim(s) 1, 5-7, & 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Martins et al. (US Patent No. 5,306,290).
Regarding Claim 1, Martins et al. discloses a method of joint repair (Fig. 1, Col. 3, Line 37 – Col. 5, Line 29) comprising: drilling a bone hole (105) through a first bone (110) and at least partially (130) into a second bone (115) adjacent the first bone (Col. 4, Lines 35-56); inserting a first anchor (135) into the bone hole in the second bone such that the first anchor does not project from a surface of the second bone (Fig. 1, Col. 4, Lines 57-68), the first anchor slidably attached to a flexible member (suture 147, Col. 4, Lines 57-68); coupling the flexible member to a second anchor (button 5, Col. 5, Lines 1-14); inserting the second anchor into the bone hole in the first bone such that the second anchor does not project from a surface of the first bone (“In this way button 5 can be completely received in counterbore 117 and make a flush fit with the walls of the counterbore”); and tensioning the flexible member to reduce a distance between the first anchor and the second anchor, thereby stabilizing and reducing the first bone relative to the second bone (Col. 5, Lines 8-29).
Regarding Claim 5, Martins et al. discloses wherein drilling the bone hole through the first bone and at least partially into the second bone comprises drilling the bone hole having a first diameter (dc in 105) in the first bone (110) and a second diameter (db in 130) in the second bone (115), the first diameter selected to be larger than the second diameter (Fig. 1).
Regarding Claim 6, Martins et al. discloses wherein inserting the first anchor into the bone hole (130) in the second bone (115) comprises inserting the first anchor (135) in the bone hole such that ends (140 & 145, at knot 155, Fig. 1, Col. 5, Lines 15-21) of the flexible member extend freely from the bone hole (105) in the first bone (110).
Regarding Claim 7, Martins et al. discloses wherein coupling the flexible member to the second anchor comprises passing the flexible member through an eyelet (through holes 35 & 40, Figs. 2-4) of the second anchor (5)(Col. 5, Lines 1-29).
Regarding Claim 16, Martins et al. discloses wherein the second anchor is a knotless anchor (button 5 is a suture receiving button, Figs. 1-4, Col. 4, Lines 32-34).
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.
Claim(s) 2-4 & 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. (US Patent No. 5,306,290) in view of Benderev et al. (US Patent No. 5,766,221).
Regarding Claims 2-4 & 18, Martins et al. discloses the claimed invention as stated above in claim 1, except wherein drilling the bone hole through the first bone and at least partially into the second bone comprises drilling the bone hole with a drill passed through a guide, wherein inserting the first anchor into the bone hole in the second bone comprising inserting the first anchor through the guide, wherein the first anchor is secured to a distal end of a driver tool configured for insertion through the guide and into the bone hole, and wherein the guide comprises a spring configured to provide pressure between the first bone and the second bone.
Benderev et al. discloses bone anchor implantation devices for installing a bone anchor in a bone (Abstract), comprising a multi-probe bone locator and drill guide centering device for locating a desired site on a bone, guiding a drill bit to the located site, retaining access to the site following drilling, and installation of a bone anchor for anchoring sutures (Col. 5, Line 65 – Col. 6, Line 4), wherein the drill guide/bone anchor implantation device (10, Figs. 1-24) is first pressed firmly against tissue in the area to be drill providing pressure on the bone and probed via spring-loaded proximally biased (65, Fig. 1, Col. 7, Lines 57-65) knobs (46) in order to identify the location of the bone, and once contact has been established, a drill bit is inserted through a guide shaft (30) formed through the device and guided to create the necessary hole in the bones (Col. 7, Line 66 – Col. 9, Line 16), and subsequently a bone anchor is advanced through the guide shaft (30) and into the drilled hole (Col. 9, Lines 27-42) via “an installation tool which facilitates holding the anchor body by means of an interference fit at the gripping point and guiding said anchor through the guide hole and compressed tissue into the bone hole is preferably utilized. (Col. 9, Lines 36-42). Benderev et al. teaches that “installation of the anchor is greatly simplified using the drill guide of the present invention because the axis of drill guide shaft 30 remains directed at the drill hole.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Martins et al. with the steps of drilling the bone hole with a drill passed through a guide, inserting the first anchor through the guide, wherein the first anchor is secured to a distal end of a driver tool configured for insertion through the guide and into the bone hole, and wherein the guide comprises a spring configured to provide pressure between the first bone and the second bone as taught by Benderev et al. in order to provide a surgeon with a means for guiding both the drill bit and the anchor into the surgical site which simplifies the installation without the need for additional surgical tools.
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. (US Patent No. 5,306,290) in view of Moore et al. (US PG Pub No. 2014/0277128).
Regarding Claims 8-9, Martins et al. discloses the claimed invention as stated above in claim 1, except wherein the second anchor is secured to an inserter tool configured for insertion into the bone hole, and wherein tensioning the flexible member comprises rotating a tensioning knob on the inserter tool.
Moore et al. discloses an inserter device for a suture anchor (Abstract), wherein the inserter device comprising an elongate outer shaft (26, Fig. 3, Paragraph [0033]), a handle portion (32), a knob (38) at a proximal end of the handle portion for controlling an inner shaft (38), wherein the inner shaft is configured to couple to a portion (112) of the anchor (22), and wherein “Suture threads that are disposed in the suture anchor 22 are threaded through the elongate apertures 92, 96 of the outer sleeve 80 and through the radially oriented aperture 120 of the anchor inner core 110. The suture threads are wound up or spooled about the outer face area 122 of the anchor inner core 110 shown in FIG. 14 by the rotation of the anchor inner core 110 relative to the anchor outer sleeve 80. The spooling of suture threads about the anchor inner core 110 causes portions of threads disposed away from the suture anchor 22 and bone to be drawn into the suture anchor 22, such as through the eyelet 84, to increase tension of the suture threads, which typically are connected to a tendon or other tissue that is intended to contact a surface of the bone. The spooling of the suture threads also creates pressure between the suture threads and the anchor outer sleeve 80 which may serve to compress the suture threads and expand the anchor outer sleeve 80 thereby increasing fixation strength.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Martins et al. with an inserter tool for the second anchor which comprises a tensioning knob for tensioning the flexible member as taught by Moore et al. in order to provide the surgeon with a means for insertion and tensioning the anchor during the procedure which prevents manual placement and tensioning by hand.
Claim(s) 10, 14 & 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. (US Patent No. 5,306,290) in view of Brown et al. (US PG Pub No. 2013/0123810).
Regarding Claim 10, Martins et al. discloses the claimed invention as stated above in claim 1, except, after tensioning the flexible member to reduce a distance between the first anchor and the second anchor, trimming an excess of the flexible member.
Brown et al. discloses methods and devices for anchoring an implant into bone (Abstract), comprising various embodiments of anchoring implants (Figs. 1-14) which comprise flexible members/sutures (120), and wherein an inserter (tube 310) is used to insert the anchoring implant into a surgical site (Paragraph [0121]) and once the implant is in place, “The suture 120 may then be trimmed to complete repair.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Martins et al. with the step of trimming the flexible member after the anchor is placed as taught by Brown et al. as an obvious and well-known step which allows a surgeon to remove any excess suture from the surgical site before completing the procedure.
Regarding Claims 14-15, Martins et al. discloses the claimed invention as stated above in claim 1, except wherein the first anchor is an all-textile anchor, and wherein the flexible member is tensionable to change a body of the first anchor from a first configuration, whereby the body is elongate, to a second configuration, whereby the body is compressed axially and extended radially to form an interference fit with the bone hole.
Brown et al. discloses various embodiments of soft/textile anchoring implants, wherein in Figs. 14-16, one specific embodiment of the implant comprises a textile braided material (Paragraphs [0088-0091]) capable of being inserted through an insertion tool in an elongated and compressed state as shown in Fig. 15 and transition to another width upon final implantation, which may better anchor itself into a surgical site by virtue of the fact that it would have more surface area contact with the surrounding tissue or bone (Paragraph [0093]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to replace the first anchor used in the method of Martins et al. with a textile/braided soft anchoring implant as taught by Brown et al. in order to provide the method with an anchor which can be easily inserted through an insertion tool in a first elongate configuration and after radially expanding, better anchor itself into a surgical site by virtue of the fact that it would have more surface area contact with the surrounding bone.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. (US Patent No. 5,306,290) in view of Denham et al. (US PG Pub No. 2011/0270306).
Regarding Claim 11, Martins et al. discloses the claimed invention as stated above in Claim 1, except wherein, after tensioning the flexible member to reduce a distance between the first anchor and the second anchor, attaching the flexible member to a third anchor in the second bone.
Denham et al. discloses a method and apparatus for coupling tissue to bone (Abstract), wherein in one embodiment, first and second anchors are used with a flexible suture member and inserted into first and second bones (Figs. 12A-12E), and in another embodiment, a plurality of anchors coupled to flexible suture members are each inserted into a bone hole formed in the bone such that multiple bone holes are formed within the bone for accepting a respective anchor (Fig. 14A, Paragraph [0043]) and wherein adjoining anchors are coupled together using loops from an adjacent flexible suture member (Paragraphs [0043-0046]). Denham et al. teaches using multiple bone holes for multiple adjacent anchors for the purpose of fixating the tissue along an elongated area.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Martins et al. with the step of attaching the flexible member to a third anchor inserted within a third bone hole in the second bone as taught by Denham et al. in order to allow a larger length of bone to be used for a more robust fixation based on a patient’s anatomy and particular needs.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. (US Patent No. 5,306,290) in view of O’Connor et al. (US PG Pub. No. 2018/0280066).
Regarding Claims 12-13, Martins et al. discloses the claimed invention as stated above in Claim 1, except after tensioning the flexible member to reduce a distance between the first anchor and the second anchor, attaching the flexible member to a brace, and wherein the method is performed through or underneath a fibular plate.
O’Connor et al. discloses apparatus and methods for joint repair using anchors and flexible members (Abstract, Fig. 9), wherein a bone plate (154) can be secured to an exterior surface of a bone (128a) through insertion of one or more screws (196)(Figs. 10A-B, Paragraph [0066]) through apertures in the bone plate, and wherein the anchoring system (100), including first and second anchor members (104”, 108) and flexible member (suture 110) can be received within an aperture through the bone plate (Paragraph [0066]) anchored to the fibula (Fig. 12, Paragraph [0053]) to provide tension on a fibula and tibia bone (128a, 128b, Figs. 12 & 15B, Paragraph [0037]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the method of Martins et al. with the step of attaching the flexible member to fibula plate, and performing the method through or underneath a fibular plate as taught by O’Connor et al. in order to provide an additional well-known and commonly used structural component along the fibula to help tension/secure the bones during stabilization and reduction at the surgical site.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Martins et al. (US Patent No. 5,306,290) in view of Dreyfuss (US PG Pub No. 2016/0074030).
Regarding Claim 17, Martins et al. discloses the claimed invention as stated above in Claim 1, except wherein the flexible member comprises suture tape.
Dreyfuss et al. discloses anchor assemblies comprising soft anchors and flexible strands for insertion into bone sockets (Paragraph [0032]), wherein one particular embodiment depicted in Fig. 1 comprises an anchor (12) and a flexible strand (14), and wherein the flexible strand is a suture, wherein “suitable sutures include FiberWire®, TigerWire®, or FiberChain® suture, although any type of suture may be utilized, including cored or coreless sutures. In another embodiment, the flexible strand 14 is suture tape, such as FiberTape®. The flexible strand 14 could include any soft, flexible strand of material.”
It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the flexible member used in the method of Martins et al. to be suture tape as taught by Dreyfuss et al. as an alternate and functionally equivalent flexible member used with anchors to stabilize bones which provides the added benefit of increased knot security and resistance to tearing.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WEISS whose telephone number is (571) 270-5597. The examiner can normally be reached Monday through Friday, 8:00 am to 4:00 pm EST. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, KEVIN T. TRUONG, at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JESSICA WEISS/Primary Examiner, Art Unit 3775