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 .
Status of the Claims
This Office Action is responsive to the amendment filed July 24, 2026. As directed by the amendment: Claims 20-25, 28, 30, and 33-36 have been amended. Claims 1-19, 27, 29, and 32 have been cancelled. Claim 39 is newly added. Claims 20-26, 28, 30, 31, and 33-39 are presently pending in this application.
Examiner’s Note
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.
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) 20-25, 28, 30, 31, and 33-39 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stark (US 2009/0024174) in view of Fruh et al. (US 2003/0009222), herein referred to as Fruh, and further in view of Greenhalgh et al. (US 2016/0296344), herein referred to as Greenhalgh.
Regarding claim 20, Stark discloses a method (figures 15-17) for post-filling a bone graft material (240) (¶76-¶79) into a sacroiliac joint implant (e.g. screw, element 100 or 232) (figures 16 and 17), the method comprising implanting a sacroiliac joint implant (e.g. screw, element 100 or 232) (figures 15-17), the sacroiliac joint implant comprising a sacroiliac screw having a body (figures 1 and 15-17) and a plurality of threads (106) extending radially outward from the body (figures 1 and 15-17) and a cannula (104) configured to (i.e. capable of) receive the bone graft material (240) and one or more openings (126) in communication with the cannula (104) (¶51), and wherein the one or more openings (126) are configured to (i.e. capable of) dispense the bone graft material (¶51).
Yet, Stark lacks wherein at least one of the one or more openings extends across two or more threads.
However, Fruh teaches one or more openings (elements 30A) (¶66) extends across two or more threads (26) (figure 2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Stark’s implant with one or more openings extends across two or more threads as taught by Fruh, since such a modification would provide an alternative implant opening shape.
Next, Stark further lacks removably coupling a bone graft delivery device to the sacroiliac joint implant after the sacroiliac joint implant is implanted, the bone graft delivery device comprising a handle and a tube coupled to the handle.
However, Greenhalgh teaches removably coupling a bone graft delivery device (100) (¶53) and to an implant (400) after the implant (400) is implanted (¶114), the bone graft delivery device (100) comprising a handle (102) (figures 10A, 10B) and a tube (120) coupled to the handle (102) (figures 10A, 10B).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide Stark’s method with removably coupling a bone graft delivery device to the implant after the implant is implanted, the bone graft delivery device comprising a handle and a tube coupled to the handle as taught by Greenhalgh, since such a modification would provide the user with a tool to deliver bone graft material to a desired surgical location (¶96).
Thus, the modified Stark’s method has providing the bone graft material (¶51 of Stark) to the sacroiliac joint implant (e.g. screw of Stark) via the bone graft delivery device (100 of Greenhalgh) to stabilize the sacroiliac joint (222 of Stark) after removably coupling the bone graft delivery device (100 of Greenhalgh) to the sacroiliac joint implant (e.g. screw of Stark).
Regarding claim 21, the modified Stark’s method has wherein removably coupling the bone graft delivery device (100 of Greenhalgh) to the sacroiliac joint implant (e.g. screw of Stark) comprises removably coupling (¶114 of Greenhalgh) a distal end of the tube (120 of Greenhalgh) to the sacroiliac joint implant (e.g. screw of Stark).
Regarding claim 22, the modified Stark’s method has wherein removably coupling the distal end of the tube (120 of Greenhalgh) to the sacroiliac joint implant (e.g. screw of Stark) comprises coupling external threads of the tube (120 of Greenhalgh) with internal threads of the sacroiliac joint implant (¶114 of Greenhalgh).
Regarding claim 23, the modified Stark’s method has wherein removably coupling the bone graft delivery device (100 of Greenhalgh) to the sacroiliac joint implant (e.g. screw of Stark) comprises coupling an adapter (800 of Greenhalgh) (¶113 and figure 14 of Greenhalgh) to a distal end of the tube (120 of Greenhalgh) and coupling the adapter (800 of Greenhalgh) to the sacroiliac joint implant (e.g. screw of Stark).
Regarding claim 24, the modified Stark’s method has wherein the bone graft delivery device (100 of Greenhalgh) comprises a plunger (112 of Greenhalgh), wherein providing the bone graft material to the sacroiliac joint implant (e.g. screw of Stark) comprises advancing the plunger (112 of Greenhalgh) (figure 2A of Greenhalgh) at least partially into the tube (120 of Greenhalgh) to advance the bone graft material through the tube (120 of Greenhalgh).
Regarding claim 25, the modified Stark’s method has wherein the handle (102 of Greenhalgh) comprises a trigger (110 of Greenhalgh), wherein providing the bone graft material to the sacroiliac joint implant (e.g. screw of Stark) comprises actuating the trigger (110 of Greenhalgh) to advance the plunger (112 of Greenhalgh) at least partially into the tube (120 of Greenhalgh).
Regarding claim 28, the modified Stark’s method has wherein a distal end of the sacroiliac screw (element 100 or 232 of Stark) is flat (figures 16 and 17 of Stark).
Regarding claim 30, the modified Stark’s method has wherein the sacroiliac screw (element 100 or 232 of Stark) is fully cannulated (¶51 of Stark) from a proximal end (¶51 of Stark) to a distal end (¶51 of Stark).
Regarding claim 31, the modified Stark’s method has wherein the body comprises a uniform internal diameter (¶50 and figure 3 of Stark) between the proximal end (¶50 and figure 3 of Stark) and the distal end (¶50 and figure 3 of Stark).
Regarding claim 33, the modified Stark’s method has wherein at least some of the one or more openings (elements 30A of Fruh) (¶66 of Fruh) extend across multiple threads (figure 2 of Fruh).
Regarding claim 34, the modified Stark’s method has wherein the one or more openings (elements 30A of Fruh) are oblong (figure 2 of Fruh).
Regarding claim 35, the modified Stark’s method has wherein the sacroiliac screw is formed of metal (¶67 of Stark).
Regarding claim 36, the modified Stark’s method has wherein the sacroiliac screw is formed of a resorbable material (¶67 of Stark).
Regarding claim 37, the modified Stark’s method has wherein the bone graft material comprises one or more of demineralized bone matrix (¶77 of Stark), synthetic bone matrix, BMP2 (¶78 of Stark), BMP7, peptide graft, and autograft material.
Regarding claim 38, the modified Stark’s method has wherein the sacroiliac joint implant (element 100 or 232 of Stark) comprises a coating comprising hydroxyapatite (¶77 of Stark) or tricalcium phosphate.
Regarding claim 39, the modified Stark’s method has further comprising a tip (800 of Greenhalgh) removably couplable (figure 14 of Greenhalgh) to a distal end of the bone graft delivery device (100 of Greenhalgh) and configured to (i.e. capable of) be inserted through the cannula (104 of Stark) of the sacroiliac joint implant (e.g. screw of Stark).
Claim(s) 26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stark, Fruh, Greenhalgh as applied to claims 20 and 24 above, and further in view of Kleiner et al. (US 8,685,031), herein referred to as Kleiner.
Regarding claim 26, the modified Stark’s method discloses all the features/elements as claimed but lacks wherein advancing the plunger comprises malleting the plunger using a mallet.
However, Kleiner teaches wherein advancing a plunger (12) comprises malleting the plunger (12) using a mallet (col. 33, ll. 40-50).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the modified Stark’s method with wherein advancing the plunger comprises malleting the plunger using a mallet as taught by Kleiner, since such a modification would deliver a control strike.
Response to Arguments
Applicant's arguments filed July 24, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments on pages 5-7, under 35 U.S.C. 103, of the Remarks are directed to the amended claim 20 and the combination of references (Stark in view of Greenhalgh). Applicant argues that Stark does not teach “the one or more openings extends across two or more threads”. Thus, the Examiner has relied upon the reference Fruh to teach applicant’s amended features, see Office Action above.
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.
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/SI MING KU/Primary Examiner, Art Unit 3775
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