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 § 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.
Claim 1, 5, 8, 13, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayer (Pat. No. US 9566103 B2) in view of Winslow (Pat. No. US 6063088) and further in view of Donner (Pub. No. US 2012/0296428 A1).
Regarding claims 1, 5, 8, 13, and 14, Mayer discloses a system (figures 1 and 5A-5H) for stabilizing a dysfunctional sacroiliac (SI) joint comprising: a tool assembly 20/21/22/23/24/25/26 (figures 5A-5H), a SI joint prosthesis (figure 1) and a prosthesis deployment assembly 27 (figure 5H), said tool assembly adapted to create said pilot SI joint opening in said dysfunctional SI joint, said tool assembly comprising a drill guide 21, a drill guide insert 22, a bone dislodging member 23, and a temporary fixation pin “K-wire” (col 10, lines 5-10), said drill guide 21 configured and adapted to be advanced to and be disposed proximate said dysfunctional SI joint in a posterior trajectory, said bone dislodging member 23 adapted to dislodge bone and create said pilot SI joint opening in said dysfunctional SI joint (col. 10, lines 40-57), said drill guide 21 comprising a proximal end and a distal end, said drill guide 21 further comprising a prosthesis internal access opening 32 sized and configured to receive said drill guide insert 22 and said SI joint prosthesis therein (col. 10, lines 40-50, col. 12, lines 40-45; figures 5A-5H), said drill guide insert 22 comprising a first drill guide lumen 35 and a second drill guide lumen 35 (figure 5C), each of said first drill guide lumen and said second drill guide lumen 35 of said drill guide insert 22 sized and configured to receive said bone dislodging member 23 and said temporary fixation pin therein (figure 5C), said drill guide 21 further adapted to be stabilized by said temporary fixation pin “K-wire” during said creation of said pilot SI joint opening in said dysfunctional SI joint by said bone dislodging member when said temporary fixation pin “K-wire” is said received in and advanced through said drill guide insert and into a portion of said pilot SI joint opening in said dysfunctional joint prior created by said bone dislodging member (the K-wire can be used as claimed because it can be placed into the drill guide lumens to stabilize the drill guide if one so desires), said SI joint prosthesis 1/2 comprising a monolithic member (col. 5, lines 28-38; col. 7, lines 40-45) configured and adapted to be inserted into and through said prosthesis internal access opening 32 of said drill guide 21 and into said pilot SI joint opening in said dysfunctional SI joint in said posterior trajectory (col. 12, lines 40-45), said prosthesis deployment assembly 27 configured and adapted to engage said SI joint prosthesis and guide said SI joint prosthesis into and through said prosthesis internal access opening 32 of said drill guide and into said pilot SI joint opening in said dysfunctional SI joint (col. 12, lines 40-45). Said bone dislodging member 23 comprises a drill bit (col. 9, line 56; figure 5D). Said SI joint prosthesis comprises a first elongated section 1, a second elongated section 1 and a bridge section 2 disposed between and connected to said first and second elongated sections (figure 10), said first elongated section comprising a first open proximal end, a first closed distal end and a first internal lumen that extends from said first open proximal end to said first closed distal end (figure 10), said first internal lumen adapted to receive an osteogenic composition therein (figure 10- the lumen can receive an osteogenic composition if one so desires), said second elongated section comprising a second open proximal end, a second closed distal end and a second internal lumen that extends from said second open proximal end to said second closed distal end, said second internal lumen adapted to receive said osteogenic composition therein (figure 10- the lumen can receive an osteogenic composition if one so desires), said bridge section 2 comprising a bridge section proximal end and a bridge section distal end, said bridge section distal end comprising a first tapered region configured and adapted to disrupt at least articular cartilage and cortical bone (figure 8C). Said SI joint prosthesis is adapted to transfix said dysfunctional SI join, when said SI joint prosthesis is said advanced into said dysfunctional SI joint (this is a functionally recited limitation. The SI joint prosthesis of figure 10 is configured to transfix an SI joint if one so desires). Said SI joint prosthesis comprises a porous structure (figure 10).
Mayer discloses the claimed invention except wherein said drill guide further comprising a plurality of K-wire lumens extending from said proximal end of said drill guide to said distal end of said drill guide, each of said plurality of K-wire lumens adapted to receive a K-wire therein and guide said K- wire to said dysfunctional SI joint when said drill guide is said disposed proximate said dysfunctional SI joint, said drill guide adapted to be fixed to said dysfunctional SI joint when said drill guide is said disposed proximate said dysfunctional SI joint and each of said plurality of K-wire lumens in said drill guide receives said K-wire therein and said K-wire is advanced to and driven into said dysfunctional SI joint. Mayer also fails to disclose wherein the drill guide insert comprises a guide pin lumen, said guide pin lumen configured to receive a guide pin therein.
Winslow teaches wherein a drill guide comprises a plurality of K-wire lumens 108 extending from said proximal end of said drill guide 102 to said distal end of said drill guide, each of said plurality of K-wire lumens 108 adapted to receive a K-wire 110 therein and guide said K- wire 110 to said dysfunctional joint when said drill guide 102 is said disposed proximate said dysfunctional joint (figure 2), said drill guide 102 adapted to be fixed to said dysfunctional SI joint when said drill guide 102 is said disposed proximate said dysfunctional SI joint and each of said plurality of K-wire lumens 108 in said drill guide receives said K-wire 110 therein and said K-wire 110 is advanced to and driven into said dysfunctional SI joint, for the purpose of positively fixing the drill guide to the joint (col. 5, line 56-col. 6, line 24).
Donner teaches wherein a drill guide insert 1067 comprises a guide pin lumen 1069 configured to receive a guide pin therein (figure 101B), for the purpose of receiving guide pins which can be positioned between the articular surfaces 1016 of the sacroiliac joint 1000 to demarcate the zone of desired treatment or safe working zones while using (paragraph 0302).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the drill guide disclosed by Mayer such that it comprises a plurality of K-wire lumens extending from said proximal end of said drill guide to said distal end of said drill guide, each of said plurality of K-wire lumens adapted to receive a K-wire therein and guide said K- wire to said dysfunctional SI joint when said drill guide is said disposed proximate said dysfunctional SI joint, said drill guide adapted to be fixed to said dysfunctional SI joint when said drill guide is said disposed proximate said dysfunctional SI joint and each of said plurality of K-wire lumens in said drill guide receives said K-wire therein and said K-wire is advanced to and driven into said dysfunctional SI joint, as taught by Winslow, in order to provide a mechanism for positively fixing the drill guide to the SI joint, reducing the chances of the drill guide shifting during use thereof.
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the drill guide insert to comprise a guide pin lumen configured to receive a guide pin therein, as taught by Donner, for the purpose of receiving guide pins which can be positioned between the articular surfaces of the sacroiliac joint to demarcate the zone of desired treatment or safe working zones while using (paragraph 0302).
Claim 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayer (Pat. No. US 9566103 B2) in view of Winslow (Pat. No. US 6063088) in view of Donner (Pub. No. US 2012/0296428) and further in view of Cavallazzi et al. (Pat. No. US 8,496,665 B2).
Regarding claim 6, Mayer as modified by Winslow and Donner discloses the claimed invention except wherein said drill bit comprises a plurality of graduated markings representing depth of said drill bit into said dysfunctional SI joint during said creation of said pilot joint opening.
Cavallazzi et al. teaches wherein said drill bit 910 comprises a plurality of graduated markings 920 representing depth of said drill bit into said dysfunctional SI joint during said creation of said pilot opening (figure 30 and 31).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the drill bit disclosed by Mayer such that it comprises a plurality of graduated markings representing depth of said drill bit into said dysfunctional SI joint during said creation of said pilot joint opening, as taught by Cavallazzi et al., in order to provide the user with a visual indicia of how deep the bone has been drilled.
Claims 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayer (Pat. No. US 9566103 B2) in view of Winslow (Pat. No. US 6063088) in view of Donner (Pub. No. US 2012/0296428) and further in view of Arnett et al. (Pat. No. US 9,615,856 B2).
Regarding claims 11 and 12, Mayer as modified by Winslow and Donner discloses the claimed invention except wherein said bridge section of said SI joint prosthesis comprises a plurality of apertures/ comprises a plurality of slots.
Arnett et al. teaches wherein the bridge section of an SI joint prosthesis comprises a plurality of apertures/slots 4008, for the purpose of carrying bone graft material or other therapeutic agents (figure 26; col. 9, lines 45-53).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the bridge section of the SI joint prosthesis to comprise a plurality of apertures/slots, as taught by Arnett et al., for the purpose of carrying bone graft material or other therapeutic agents to assist in fixation of the implant.
Claim 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayer (Pat. No. US 9566103 B2) in view of Winslow (Pat. No. US 6063088) in view of Donner (Pub. No. US 2012/0296428) and further in view of Black et al. (Pub. No. US 2016/0310197 A1).
Regarding claim 15, Mayer as modified by Winslow and Donner discloses the claimed invention except wherein said tool assembly further comprises a bone harvester assembly adapted to extract and collect dislodged bone material from said bone dislodging member during creation of said pilot SI joint opening in said dysfunctional SI joint.
Black et al. teaches wherein a tool assembly comprises a bone harvester assembly 900 adapted to extract and collect dislodged bone material from said bone dislodging member during creation of said pilot SI joint opening in said dysfunctional SI joint (paragraph 0071).
It would have been obvious to a person having ordinary skill in the art at the time the invention was effectively filed to modify the tool assembly disclosed by Mayer and Winslow to comprise a bone harvester assembly adapted to extract and collect dislodged bone material from said bone dislodging member during creation of said pilot SI joint opening in said dysfunctional SI joint, as taught by Black et al., in order to clear the joint space from debris and collect autograft bone for use in implantation.
Response to Arguments
Applicant’s amendments have overcome the 35 U.S.C. 101 and 35 U.S.C. 112 first paragraph rejections.
In response the Applicant’s argument that Mayer fails to disclose a temporary fixation pin, the office respectfully disagrees. The K-wire disclosed by Mayer meets the limitations of the claimed temporary fixation pin. The claims do not require actual placement of the temporary fixation pin in the drill guide insert. Rather, they functionally recite the limitation. The K-wire disclosed by Mayer is capable of being placed in the lumens of the drill guide insert and can therefore function as claimed.
In response the Applicant’s argument that the prosthesis of Mayer is not monolithic, it is noted that Mayer teaches an embodiment in figure 1 which is monolithic (col. 7, lines 40-45).
In response to Applicant’s argument regarding the combination of Mayer with Winslow, it appears as though Applicant does not argue the merits of Winslow, but rather relies upon the argument that Mayer does not disclose a temporary fixation pin. However, as noted above, the K-wire of Mayer meets the claimed limitations of a temporary fixation pin.
In response to Applicant’s argument regarding the combination of Mayer with Winslow and Cavalazzi, it appears as though Applicant does not argue the merits of Cavalazzi, but rather relies upon the argument that Mayer does not disclose a temporary fixation pin. However, as noted above, the K-wire of Mayer meets the claimed limitations of a temporary fixation pin.
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 Lynnsy Summitt whose telephone number is (571)270-7856. The examiner can normally be reached on Monday through Thursday from 9am until 3pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. 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.
/LYNNSY M SUMMITT/Primary Examiner, Art Unit 3773
Prosecution Insights