Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/23/2025 has been entered.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 32 – 35, 49, 51, 60, 67-69, 77-79, 81-85 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Stark (US 2009/0024174 A1) in view of Lins (US 2015/0088200 A1).
Regarding claim 32, Stark discloses a method for repairing a sacroiliac joint of a patient (Abstract), comprising:
a. creating a first incision proximal to the patient's sacroiliac joint (paragraph [0073]);
b. inserting a surgical tool into said incision (paragraph [0073] discloses the use of a cannula);
c. creating a void in said sacroiliac joint (paragraph [0075] discloses the use of a drill or reamer, which would create a void);
d. inserting a single fusion implant (ref. 232, Fig. 17) into said void along a path that is substantially parallel to articular surfaces of the sacroiliac joint (Figs. 16 – 17), and no further fusion implants are introduced into the sacroiliac joint after the insertion of the single fusion implant (Fig. 17), said fusion implant having at least one bone-piercing protrusion for engagement with bone tissue in an articular surface of at least one of the sacrum and the ilium of said sacroiliac joint (Figs. 1 – 11 show different embodiments of the fusion implant, each having bone piercing protrusions in the form of threads) and at least one passage therethrough for holding a fusion promoting material and allowing growth of bone through said at least one passage (paragraphs [0004, 34] disclose that the implant may be porous, fenestrated, hollow and/or cannulated to receive material); and
e. rotating the fusion implant within the void, wherein said rotation drives the at least one bone-piercing element into said bone tissue such that said at least on bone-piercing element and embeds penetrates into the bone tissue in an articular surface of at least one of an ilium and a sacrum in said sacroiliac joint as the fusion implant is rotated such that the implant spans a joint space between the ilium and sacrum and articular surfaces of the sacrum and ilium, thereby fixing the ilium and sacrum in relative lateral positions (paragraph [0076] discloses screwing the implant into the void, thus rotating, such that the threads of the implant are penetrated into the bone, see Fig. 17, to immobilize the joint).
Stark is silent that the surgical tool has at least one tang on a distal end, said surgical tool having a tapered edge adjacent to said at least one tang.
Lins teaches a surgical tool (Fig. 12, ref. 36) having a tapered edge (Fig. 14) adjacent to at least one tang (refs. 46, 44). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical tool of Stark such that the surgical tool has a tapered edge adjacent to said at least one tang, as taught by Lins, for the purpose of easier insertion into the target surgical site.
Regarding claim 33, Stark in view of Lins discloses the method of claim 32, further comprising removing cortical tissue from said articular surfaces of said sacrum and said ilium prior to inserting said fusion implant into said void (Stark discloses drilling a bore through the SI joint which passes through and removes cortical and cancellous bone tissue to prepare the joint for the implant).
Regarding claim 34, Stark in view of Lins discloses the method of claim 32, wherein said at least one bone piercing protrusion penetrates and embeds in the cancellous bone tissue of articular surfaces of said sacrum and said ilium as the single fusion implant is rotated, thereby fixing the sacroiliac joint and securing the single fusion implant in the sacroiliac joint (Stark, the threads of the implant are configured to embed into the bone of the SI joint, see Fig. 17, as the implant is rotated or screwed into the void).
Regarding claim 35, Stark in view of Lins discloses the method of claim 32, further comprising driving said fusion implant into said void (paragraph [0037]), wherein driving said fusion implant engages said at least one bone- piercing protrusion (the threads of the implant are considered the bone-piercing protrusions) with said bone tissue, wherein said at least one bone-piercing protrusion includes a first bone-piercing protrusion having a first cutting edge at a distal end thereof (see remarked Fig. 1 below) and said fusion implant includes a second bone-piercing protrusion having a second cutting edge at a distal end thereof (see remarked Fig. 1 below), wherein said step of driving said single fusion implant into the void includes positioning said first cutting edge in proximity to an articular surface of said ilium and positioning said second cutting edge in proximity to an articular surface of said sacrum and said step of rotating the single fusion implant or a portion thereof embeds the first and second bone- piercing elements in the articular surfaces of the sacroiliac joint and secure the fusion implant in the sacroiliac joint (when the implant is initially positioned, see Fig. 16, a first cutting edge may be aligned with the ilium and the second cutting edge may be aligned with the sacrum then rotated to further embed the threads into the bony surfaces of the SI joint).
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Regarding claim 49, Stark discloses a method for repairing a sacroiliac joint of a patient (Abstract), comprising:
a. creating an incision proximal to the patient's sacroiliac joint (paragraph [0073]);
b. inserting a surgical instrument into said incision from the posterior of the patient (paragraph [0073] discloses the use of a cannula which is considered to be the surgical instrument and Fig. 14 shows a posterior approach);
c. creating a void between an articular surface of an ilium and an articular surface of a sacrum in said sacroiliac joint (paragraphs [0075 - 76] discloses the use of a drill or reamer, which would create a void, ref. 240);
d. inserting a fusion implant (ref. 232) into said void at an access point and along a path that is substantially parallel to said articular surfaces (Figs. 16 - 17) and no further fusion implants are introduced into the sacroiliac joint after the insertion of the single fusion implant (Figs. 16 – 17), said fusion implant having at least one helical bone-piercing anchor for penetrating engagement with bone tissue in an articular surface of at least one of the sacrum and the ilium of said sacroiliac joint (Figs. 1 – 11 show different embodiments of the implant, all having a helical thread configured to pierce bone tissue) and at least one passage therethrough for holding a fusion promoting material and allowing growth of bone through said at least one passage (paragraphs [0004, 34] disclose that the implant may be porous, fenestrated, hollow and/or cannulated to receive material); and
e. rotating said fusion implant to drive said fusion implant into said void and continuing to rotate at least portions of said fusion implant while within said void such that said at least one bone-piercing anchor penetrates engages with said bone tissue such that the implant spans a joint space between the ilium and sacrum and said articular surfaces of said sacrum and ilium, and said fusion implant fixes relative positions of said sacrum and said ilium (paragraph [0076] discloses screwing the implant into the void, thus rotating, such that the threads of the implant are penetrated into the bone, see Fig. 17, to immobilize the joint).
Stark is silent that the surgical instrument has a distal tang.
Lins teaches a surgical tool (Fig. 12, ref. 36) having a tapered edge (Fig. 14) adjacent to at least one distal tang (refs. 46, 44). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical tool of Stark such that the surgical tool has a tapered edge adjacent to said at least one tang, as taught by Lins, for the purpose of easier insertion into the target surgical site.
Regarding claim 51, Stark in view of Lins discloses the method of claim 49, wherein said at least one helical bone- piercing anchor comprises a sharp end for piercing said bone tissue in an articular surface of at least one of said sacrum and said ilium (Stark, the sharp end may be considered the distal most point ref. 132 as seen in Fig. 1, or any of the distal threads).
Regarding claim 60, Stark in view of Lins discloses the method of claim 51, wherein said fusion implant is operable to connect said sacrum to said ilium in fixed relative positions in the sacroiliac joint by said at least one helical bone-piercing anchor piercing and embedding in the cancellous bone tissue of said sacrum and ilium (Stark, the threaded implant is configured to immobilize the joint, paragraph [0001], via the exterior threads which are considered to be the helical anchor).
Regarding claim 58, Stark in view of Lins discloses the method of claim 49, wherein driving said fusion implant into said void comprises rotating said fusion implant having said at least one helical bone-piercing anchor that penetrates and embeds in the bone tissue in an articular surface of at least one of an ilium and a sacrum in the sacroiliac joint as the fusion implant or a portion thereof is rotated thereby fixing the ilium and sacrum in relative lateral positions and the fusion implant in the sacroiliac joint (Stark, paragraph [0037] discloses screwing the implant and thus rotating the implant so that bone-piercing elements such as the threads, embed into the bones of the SI joint to immobilize the joint).
Regarding claim 67, Stark in view of Lins discloses the method of claim 49, wherein the inserting the fusion implant comprises:
attaching said fusion implant to an inserter tool, wherein the inserter tool has a proximal end configured to attach to the implant (Stark, paragraph [0049] discloses a driving tool configured to engaged with the proximal end ref. 110 of the implant);
but is silent regarding the step of
b. inserting the inserter tool through said surgical instrument and advancing the inserter tool until an insertion control protrusion is arrested by an insertion control mechanism at a pre-determined point in a hollow barrel, and said inserter tool is prevented from moving the fusion implant further into said sacroiliac joint.
Lins teaches an analogous surgical method of fusion of spinal joints (Abstract) comprising the components of a surgical instrument (paragraph [0038], ref. 36, Fig. 4) having an insertion control mechanism (“one or more recesses” as recited in paragraph [0038]), a surgical tool (ref. 34) having an insertion control protrusion (ref. 46) which is configured to be arrested by the insertion control mechanism at a pre-determined point (paragraph [0038]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical instrument and inserter tool of Stak in view of Lins to include the insertion control protrusion and mechanism to control and guide the depth of penetration of the inserter tool within the surgical instrument (paragraph [ 0038]). It is noted that the combination of Stak and Lins results in a method in which the inserter tool (Stark, paragraph [0049]) is prevented from moving the fusion implant further into the sacroiliac joint due to the insertion control mechanism and protrusion (as taught by Lins).
Regarding claim 69, Stark in view of Lins discloses the method of claim 49, wherein driving the at least one helical bone- piercing anchor includes a first bone-piercing anchor having a first cutting edge at a distal end thereof (see remarked Fig. 1 below of Stark) and said fusion implant includes a second helical bone-piercing anchor having a second cutting edge at a distal end thereof (see remarked Fig. 1 below), wherein said step of inserting said single fusion implant into the void includes positioning said first cutting edge in proximity to an articular surface of said ilium and positioning said second cutting edge in proximity to an articular surface of said sacrum and rotating the single fusion implant fixes the articular surfaces of the sacroiliac joint together and secures the fusion implant in the sacroiliac joint (when the implant is initially positioned, see Fig. 16, a first cutting edge may be aligned with the ilium and the second cutting edge may be aligned with the sacrum then rotated to further embed the threads into the bony surfaces of the SI joint).
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Regarding claim 77, Stark discloses a method for repairing a sacroiliac joint of a patient (Abstract), comprising:
a. creating an incision proximal to the patient's sacroiliac joint to allow access to a portion of the sacroiliac joint (paragraph [0073], Fig. 14);
b. inserting a surgical instrument into said incision from the posterior of the patient (paragraph [0073] discloses a cannula which is considered the surgical instrument);
c. using an inserter tool to insert a fusion implant into said sacroiliac joint on a path that is substantially parallel to articular surfaces of the sacroiliac joint, said fusion implant having at least one bone-piercing protrusion (Figs. 1 – 11 show different embodiment of the fusion implant and paragraph [0049] discloses a driving tool/insertion tool for inserting the implant into the SI joint parallel to the articular surfaces, Figs. 16 – 17);
d. advancing the inserter tool until the fusion implant passes through said surgical instrument into said sacroiliac joint at an access point and along a path that is substantially parallel to articular surfaces of the sacroiliac joint (Stark discloses the use of a cannula through which the implant and thus inserter tool pass through to perform the surgical procedure, Figs. 16 – 17 show the path to be substantially parallel to the articular surfaces of the joint); and
e. driving said fusion implant into said sacroiliac joint and continuing to rotate portions of said fusion implant while within said void such that said at least one bone-piercing protrusion penetrates and embeds in cancellous bone tissue of articular surfaces of the ilium and sacrum such that the fusion implant spans a joint space between the ilium and sacrum and the articular surfaces of the sacrum and ilium and no further fusion implants are introduced into the sacroiliac joint after the insertion of the single fusion implant (the implant is in the form of a threaded screw which is configured to be “screwed” into the joint and thus rotated, the implant will be rotated even after a distal end is inserted into the joint).
Stark is silent regarding the distal end of the surgical instrument having a plurality of tangs.
Lins teaches a surgical tool (Fig. 12, ref. 36) having a plurality of distal tangs (refs. 46, 44, Fig. 5). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical instrument of Stark such that the distal end has a plurality of tangs, as taught by Lins, for the purpose of easier insertion and anchoring into the target surgical site.
Regarding claim 78, Stark in view of Lins discloses the method of claim 77, wherein said at least one bone-piercing protrusion comprises a helical anchor (Stark, Fig. 1).
Regarding claim 79, Stark in view of Lins discloses the method of claim 78, wherein said at least one bone piercing protrusion having a sharp end for piercing said bone tissue, and said helical anchor first penetrates said articular surface of said at least one of said sacrum and said ilium (the sharp ends of the threading are configured to pierce and embed into the bony surfaces of the joint).
Regarding claim 81, Stark in view of Lins discloses the method of Claim 77, further comprising creating a void in the sacroiliac joint having a complementary shape to the fusion implant, wherein said fusion implant is inserted into said void (Stark, paragraph [0075]).
Regarding claim 82, Stark in view of Lins discloses the method of claim 32, wherein said at least one bone piercing protrusion comprises a helical anchor having a sharp end for piercing said bone tissue in an articular surface of at least one of said sacrum and said ilium (Stark, Fig. 1).
Regarding claim 83, Stark in view of Lins discloses the method of claim 32, wherein said surgical tool includes two tangs and said step of inserting said at least one tang on said distal end of said surgical tool into said incision comprises inserting said two tangs on said distal end of said surgical tool into said sacroiliac joint with the two tangs positioned between the articular surfaces of said sacroiliac joint.
Regarding claim 84, Stark in view of Lins discloses the method of claim 49, wherein said surgical instrument includes two distal tangs and said step of inserting said distal tang of the surgical instrument into said incision comprises said two distal tangs into said sacroiliac joint with the two distal tangs positioned between the articular surfaces of said sacroiliac joint (Stark as modified by Lins discloses two distal tangs, see Fig. 5 of Lins).
Regarding claim 85, Stark in view of Lins discloses method of claim 32, except wherein said surgical tool includes a hollow barrel that includes an interior guidance slot in an interior diameter thereof that is operable to engage and align a slot-engagement protrusion of one or more surgical tools to be inserted into said hollow barrel, wherein engagement of said slot-engagement protrusion with said guidance slot controls the depth of advancement of surgical tools through said hollow barrel and maintains said one or more surgical tools in proper orientation for insertion into said incision.
Lins teaches an analogous surgical method of fusion of spinal joints (Abstract) comprising the components of a surgical instrument (paragraph [0038], ref. 36, Fig. 4) having an insertion control mechanism (“one or more recesses” as recited in paragraph [0038]), a surgical tool (ref. 34) having an insertion control protrusion (ref. 46) which is configured to be arrested by the insertion control mechanism at a pre-determined point (paragraph [0038]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical instrument and inserter tool of Stark in view of Lins to include the insertion control protrusion and mechanism to control and guide the depth of penetration of the inserter tool within the surgical instrument (paragraph [ 0038]). It is noted that the combination of Stark and Lins results in a method in which the inserter tool is prevented from moving the fusion implant further into the sacroiliac joint due to the insertion control mechanism and protrusion, as taught by Lins.
Response to Arguments
Applicant’s arguments with respect to claim(s) 12/15/2025 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.
Allowable Subject Matter
Claims 40 and 41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892.
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/TESSA M MATTHEWS/Examiner, Art Unit 3773