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 Status
Applicant’s Remarks and Amendments filed 12 March 2026 have been entered. Claims 1-4, 6-8, 10, and 21-32 are pending.
Response to Arguments
Applicant’s arguments, see pg. 7 of remarks, filed 12 March 2026, with respect to the drawings have been fully considered and are persuasive. The objection of the drawings has been withdrawn.
Applicant’s arguments, see pg. 7 of remarks, filed 12 March 2026, with respect to the specification have been fully considered and are persuasive. The objection of the specification has been withdrawn.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any combination of references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Claims 1-10 and 21-32 are rejected under 35 U.S.C. 103 as being unpatentable over Lavigne et al. (US 2016/0100870 A1), “Lavigne” in view of Tsai et al. (US Pat. No. 11141262 B2), “Tsai”.
Regarding claim 1, Lavigne teaches a sacroiliac joint implant system, comprising: a primary implant (Fig. 1A, implant 1) configured to be received in a sacroiliac joint of a patient (Fig. 1A, bone implant 1 adapted for a sacro-iliac joint [0040]), the primary implant (Fig. 1A, implant 1) comprising: a body (Fig. 1A, body 10) extending from a proximal end (Fig. 1B, top portion of body 10) to a distal end (Fig. 1B, bottom portion of body 10), the body (Fig 1A, body 10) comprising a head on the proximal end (Fig. 1B, head 18 near top portion of body 10) and an elongate member extending distally from the head (Fig. 1B, body 10 extends from head 18 to comprise a bottom portion (i.e., distal end); and a plurality of engagement features extending from the elongate member of the body (Fig. 1A, turns 12 of the threading of the body 10 [0057]), the plurality of engagement features configured to provide fixation of the primary implant within the sacroiliac joint (Fig. 1A, turns 12 promote retention of the implant in the bone tissue [0057]); and a secondary implant configured to couple with the primary implant (Fig. 1A, stabilizing element 2 connected to implant 1), the secondary implant (Fig. 1 A, stabilizing element 2) comprising: a central body configured to receive the head of the primary implant (Fig. 1B, stabilizing element 2 comprises a central region under locking means 3 which engages head 18 [0061]); a plurality of extensions extending laterally from the central body (Fig. 1B, plates 20 extend from central region of stabilizing element 2); and a plurality of anchors (Fig. 1B, rods 21), the plurality of anchors (Fig 1B, rods 21) comprising: a first anchor (Fig. 1B, left rod 21) extending from one of the plurality of arms (Fig. 1B, plates 20) and configured to anchor within a sacrum of the patient (Fig. 1A, rods 21 are positioned in ideal positions relative to the treated bone structures (i.e., in adjacent bone structures such as the sacrum and ilium) [0061]); and a second anchor (Fig. 1B, right rod 21) extending from one of the plurality of arms (Fig. 1B, plates 20) and configured to anchor within an ilium of the patient (Fig. 1A, rods 21 are positioned in ideal positions relative to the treated bone structures (i.e., in adjacent bone structures such as the sacrum and ilium) [0061]), wherein each of the first and second anchor comprises: a leading edge shaped to cut bone (Fig. 3D, rods 21 comprise pointed free ends able to penetrate bone tissue [0060]); a first face aligned with the leading edge (Fig. 3A, inside edge of beveled tip of rod 21); a second face offset from the leading edge (Fig. 3A, outer edge of beveled tip of rod 21); a tapered portion extending from the second face to the leading edge (Fig. 3A, rod 21 comprises beveled edge which tapers to be able to penetrate bone tissue [0060]), but fails to teach one or more openings extending between the first face and the second face and configured to facilitate bony ingrowth.
Tsai teaches a bone implant comprising one or more openings extending between the first and face and the second face and configured to facilitate bony ingrowth (Fig. 8, helix body 311 comprises a plurality of holes 31a which allow for bone growth within (col. 6, lines 27-35)). Tsai discloses that the ingrowth of bone within the holes improves bonding strength between the implantation site and the implant (col. 6, lines 27-35). Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to combine the leading edge comprising a first and second face as taught by Lavigne with the helix body edge comprising holes for bone ingrowth in order to prevent dislodging of the implant.
Regarding claim 2, Lavigne teaches wherein the primary implant (Fig. 1A, implant 1) comprises a plurality of tabs (Fig. 2A, extensions formed by notches 14) defining a plurality of recesses (Fig. 2A, notches 14), wherein the plurality of recesses are configured to receive the secondary implant (Fig. 1A, notches receive rods 21 of stabilizing element 2 [0061]).
Regarding claim 3, Lavigne teaches wherein the central body of the secondary implant (Fig. 1B, stabilizing element 2 comprises a central region under locking means 3 which engages head 18 [0061]) comprises a ring configured to receive the head of the primary implant (Fig. 2C, stabilizing element 2 comprises a ring which is slipped onto head 18 [0060]).
Regarding claim 4, Lavigne teaches wherein the ring is configured to couple with the head of the primary implant (Fig. 2C, stabilizing element 2 comprises a ring which is slipped onto head 18 [0060]) to facilitate polyaxial movement of the primary implant relative to the secondary implant (Fig. 1A, stabilizing element 2 (i.e., bell) allows for polyaxial movement [0064])).
Regarding claim 6, Lavigne teaches further comprising a fastener configured to couple the primary implant and the secondary implant (Fig. 1D, locking means 3 attaches heads of both implant 1 and stabilizing element 2 [0060]).
Regarding claim 7, Lavigne teaches wherein the primary implant (Fig. 1A, implant 1) comprises a channel configured to receive bone graft material (Fig. 1D, longitudinal internal conduit 11 is filled with exogenous bone tissue during implantation [0049]).
Regarding claim 8, Lavigne teaches wherein the primary implant (Fig. 1A, implant 1) comprises one or more openings between the channel (Fig. 1D, longitudinal internal conduit 11) and an exterior of the primary implant (Fig. 1D, windows 15 are flared from inside to outside of body 10 [0048]).
Regarding claim 10, Lavigne teaches wherein each of the plurality of anchors (Fig. 1A, rods 21) comprises a leading edge configured to cut bone (Fig. 3D, rods 21 comprise pointed free ends able to penetrate bone tissue [0060]).
Regarding claim 21, Lavigne teaches wherein the head of the primary implant (Fig. 1B, head 18 of implant 1) is configured to be advanced distally through the central body of the secondary implant (Fig. 2C, stabilizing element 2 comprises a ring which is slipped onto head 18 [0060]).
Regarding claim 22, Lavigne teaches wherein each of the plurality of anchors (Fig. 1A, rods 21) extend distally from one of the plurality of arms (Fig. 3D, rods 21 extend distally from plates 20 of stabilizing element 2).
Regarding claim 23, Lavigne teaches wherein the head of the primary implant (Fig. 1B, head 18 of implant 1) is shaped to restrict proximal movement of at least a portion of the central body when positioned within an opening defined by the central body (Fig. 6D, ring 23 of stabilizing element 2 is slipped onto high portion 13 which juts out from head 18 of implant 1 [0060] (i.e., head is shaped to secure stabilizing element)).
Regarding claim 24, Lavigne teaches wherein the elongate member (Fig. 1A, body 10) of the primary implant (Fig. 1A, implant 1) comprises a smooth shank section proximal to the plurality of engagement features (Fig. 1B, head 18 of body 10 is proximal to turns 12 and does not comprise turns 12).
Regarding claim 25, Lavigne teaches wherein the body of the primary implant (Fig. 1A, body 10 of implant 1) comprises a tapered distal end (Fig. 26B, implant 1 comprises a pointed free end [0054]).
Regarding claim 26, Lavigne teaches wherein the first anchor and the second anchor are integrally formed with one another (Fig. 1A, rods 21 are both comprised within stabilizing element 2).
Regarding claim 27, Lavigne teaches wherein the central body (Fig. 3D, ring 23), the plurality of arms (Fig. 3D, plates 20), the first anchor (Fig. 1A, left rods 21), and the second anchor (Fig. 1A, right rod 21) are integrally formed (Fig. 3D, ring 23, plates 20, and rods 21 are all comprised within stabilizing element 2).
Regarding claim 28, Lavigne teaches wherein the leading edge tapers to a sharp distal point (Fig. 3D, rods 21 comprise pointed free ends able to penetrate bone tissue [0060]).
Regarding claim 29, Lavigne teaches wherein the secondary implant (Fig. 1A, stabilizing element 2) tapers from a proximal end to a distal end to compress the sacroiliac joint when the first anchor is driven into the sacrum and the second anchor is driven into the ilium (Fig. 3D, rods 21 comprise pointed free ends (i.e., tapered) able to penetrate bone tissue [0060]).
Regarding claim 30, Lavigne teaches wherein each of the first anchor and the second anchor (Fig. 1A, rods 21) comprises a curved wedge (Fig. 3D, rods 21 comprise pointed free ends (i.e., wedge) within stabilizing element 2 which may be curved [0066]).
Regarding claim 31, Lavigne teaches wherein the curved wedge of each of the first anchor and the second anchor (Fig. 3D, rods 21 comprise pointed free ends (i.e., wedge) within stabilizing element 2 which may be curved [0066]) comprises a beveled distal end (Fig. 3D, distal ends of rods 21 are tapered (i.e., beveled)).
Regarding claim 32, Lavigne teaches wherein each of the first anchor and the second anchor (Fig. 1A, rods 21) comprises one or more truss elements forming the one or more openings (Fig. 1B, longitudinal internal conduit 11 and turns 12 comprised on body 10 form windows 15 [0042-0043]).
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 GABRIELLA GISELLE B RIOS whose telephone number is (703)756-5958. The examiner can normally be reached M-Th 7:30-6:00 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.
/G.G.R./ Examiner, Art Unit 3774
/THOMAS C BARRETT/ SPE, Art Unit 3799
Prosecution Insights