DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the AIA first to file provisions because at least one claim contains subject matter only disclosed on or after March 16, 2013.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 18/208,963, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The limitation “wherein at least one of the first lateral superior stabilizer surface, the second lateral superior stabilizer surface, the first lateral inferior stabilizer surface, and the second lateral inferior stabilizer surface comprise at least one outwardly-extending tab” (last six lines of claim 1, also see fig. 24) are not supported by Application No. 18/208,963. The effective filing date of the invention is the date of filing: 6/10/2024.
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) 1-10, 12, 16 and 17 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Donner (US 20140336763) as cited in the IDS.
With respect to claim 1, Donner discloses a stabilization implant (25) (see fig. 62-63 below, note that fig. 64-71 are also applicable) comprising: an elongated body (45) having a distal end (insertion end 47), a proximal end (45) and a longitudinal axis (see fig. 62-63 below) extending between the distal end and the proximal end, the elongated body being characterized by a superior body surface (upper surface) and an inferior body surface (lower surface) (see fig. 62-63 below); a superior stabilizer extending outwardly from the superior body surface (see fig. 62-63 below), the superior stabilizer being characterized by a first lateral superior stabilizer surface and a second lateral superior stabilizer surface (see fig. 62-63 below); and an inferior stabilizer (see fig. 62-63 below) extending outwardly from the inferior body surface, the inferior stabilizer being characterized by a first lateral inferior stabilizer surface and a second lateral inferior stabilizer surface (see fig. 62-63 below); wherein at least one of the first lateral superior stabilizer surface, the second lateral superior stabilizer surface, the first lateral inferior stabilizer surface, and the second lateral inferior stabilizer surface comprise at least one outwardly-extending tab (355) (see para. 215).
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As for claim 2, Donner further discloses a stabilization implant according to claim 1 wherein the at least one outwardly-extending tab comprises an angled distal surface (tip) and a proximal surface (attached to the respective stabilizer) which is disposed generally perpendicular to the first lateral superior stabilizer surface, the second lateral superior stabilizer surface, the first lateral inferior stabilizer surface, and/or the second lateral inferior stabilizer surface out of which the at least one outwardly-extending tab extends (see fig. 62-63 above, also fig. 64-71).
As for claim 3, Donner further discloses the stabilization implant according to claim 1 wherein the first lateral superior stabilizer surface, the second lateral superior stabilizer surface, the first lateral inferior stabilizer surface, and the second lateral inferior stabilizer surface comprise at least two outwardly-extending tabs (see fig. 62-63 above).
As for claim 4, Donner further discloses a stabilization implant according to claim 3 wherein a first tab (e.g., distal-most tab) of the at least two outwardly-extending tabs extends outward a first distance (e.g., from the upper surface of the stabilizer), a second tab (e.g., proximal-most tab) of the at least two outwardly-extending tabs extends outward a second distance (e.g.,, from the upper surface of the stabilizer) and further wherein the first distance is greater than the second distance (see fig. 62-63 above).
As for claim 5, Donner further discloses a stabilization implant according to claim 1 wherein the elongated body comprises at least one window (40) formed in the elongated body for promoting bony in-growth (see para. 215).
As for claim 6, Donner further discloses a stabilization implant according to claim 5 wherein the at least one window comprises a bone growth promoter (see para. 460 and note that the window can contain either an anchor or bone growth material).
As for claim 7, Donner further discloses a stabilization implant according to claim 5 wherein the at least one window passes through the elongated body so as to open on the superior body surface and the inferior body surface (see para. 215).
As for claim 8, Donner further discloses a stabilization implant according to claim 5 wherein the at least one window passes through the elongated body so as to open on the first lateral surface and the second lateral surface (see para. 215, fig. 4).
As for claim 9, Donner further discloses a stabilization implant according to claim 1 wherein the distal end of the elongated body terminates in a distal mouth (e.g., 42), and further wherein the distal mouth extends proximally into the elongated body (see fig. 43).
As for claim 10, Donner further discloses a stabilization implant according to claim 9 wherein the distal mouth comprises a distalmost circumferentially-extending distal end cutting surface (see para. 223).
As for claim 12, Donner further discloses a stabilization implant according to claim 1 wherein the elongated body is symmetrical about the longitudinal axis of the elongated body (see fig. 62-63 above).
As for claim 16, Donner further discloses a stabilization implant according to claim 1 wherein the elongated body comprises a proximal end surface (at 45), the superior stabilizer comprises a proximal end surface and the inferior stabilizer comprises a proximal end surface (at 45), and further wherein the proximal end surface of the elongated body, the proximal end surface of the superior stabilizer and the proximal end surface of the inferior stabilizer are all coplanar (see fig. 63 above).
With respect to claim 17, Donner discloses a method of positioning an implant (25) in a sacroiliac joint (see abstract), the method comprising: providing a stabilization implant (see fig. 62-63, note that fig. 64-71 also apply) comprising: an elongated body having a distal end (47), a proximal end (45) and a longitudinal axis extending between the distal end and the proximal end (see fig. 62-63 above), the elongated body being characterized by a superior body surface and an inferior body surface (e.g., upper and lower surfaces); a superior stabilizer extending outwardly from the superior body surface (see fig. 62-63 above), the superior stabilizer being characterized by a first lateral superior stabilizer surface and a second lateral superior stabilizer surface (see fig. 62-63 above); and an inferior stabilizer extending outwardly from the inferior body surface, the inferior stabilizer being characterized by a first lateral inferior stabilizer surface and a second lateral inferior stabilizer surface (see fig. 62-63 above); wherein at least one of the first lateral superior stabilizer surface, the second lateral superior stabilizer surface, the first lateral inferior stabilizer surface, and the second lateral inferior stabilizer surface comprise at least one outwardly-extending tab (355); forming an implant cavity for receiving the elongated body of the stabilization implant, wherein forming the implant cavity comprises forming a first cavity in an ilium of the sacroiliac joint and forming a second cavity in a sacrum of the sacroiliac joint, with the implant cavity spanning the sacroiliac joint (see fig. 99g-99j); and inserting the elongated body of the stabilization implant into the implant cavity (see fig. 99j).
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(s) 11 and 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Donner (US 20140336763), as applied to claim 1 above, as cited in the IDS.
As for claims 11 and 13-15, Donner (the relied upon embodiment fig. 62-71) does not appear to teach wherein the stabilization implant is asymmetric about the longitudinal axis of the elongated body; wherein the superior stabilizer and the inferior stabilizer have differing profiles in side view; wherein the distal end of the elongated body terminates in a distal end surface, wherein the elongated body comprises a beveled surface extending between the superior body surface and the distal end surface, and wherein the elongated body comprises a beveled surface extending between the inferior body surface and the distal end surface; wherein the beveled surface extending between the superior body surface and the distal end surface extends at a first angle to the longitudinal axis of the elongated body, and the beveled surface extending between the inferior body surface and the distal end surface extends at a second angle to the longitudinal axis of the elongated body, and further wherein the first angle and the second angle are the same.
Donner teaches another embodiment (figs. 119a-11d) wherein the stabilization implant is asymmetric about the longitudinal axis of the elongated body (see fig. 119b, para. 348, 373 and note tapered shape); wherein the superior stabilizer and the inferior stabilizer have differing profiles in side view (see fig. 119d); wherein the distal end of the elongated body terminates in a distal end surface (tip/end/nose), wherein the elongated body comprises a beveled surface (see para. 199) extending between the superior body surface and the distal end surface, and wherein the elongated body comprises a beveled surface extending between the inferior body surface and the distal end surface (see fig. 119a); and wherein the beveled surface extending between the superior body surface and the distal end surface extends at a first angle to the longitudinal axis of the elongated body (see fig. 119 a), and the beveled surface extending between the inferior body surface and the distal end surface extends at a second angle to the longitudinal axis of the elongated body, and further wherein the first angle and the second angle are the same (see fig. 119a) in order to allow easy insertion of the implant into the bone (see para. 348).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify Donner (embodiment of fig. 62-71) wherein the stabilization implant is asymmetric about the longitudinal axis of the elongated body; wherein the superior stabilizer and the inferior stabilizer have differing profiles in side view; wherein the distal end of the elongated body terminates in a distal end surface, wherein the elongated body comprises a beveled surface extending between the superior body surface and the distal end surface, and wherein the elongated body comprises a beveled surface extending between the inferior body surface and the distal end surface; wherein the beveled surface extending between the superior body surface and the distal end surface extends at a first angle to the longitudinal axis of the elongated body, and the beveled surface extending between the inferior body surface and the distal end surface extends at a second angle to the longitudinal axis of the elongated body, and further wherein the first angle and the second angle are the same, in view of Donner (embodiment of fig. 119a-119d), in order to allow easy insertion of the implant into the bone.
Conclusion
Applicant's submission of an information disclosure statement under 37 CFR 1.97(c) with the timing fee set forth in 37 CFR 1.17(p) on 12/16/2025 prompted the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609.04(b). 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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/TARA ROSE E CARTER/ Examiner, Art Unit 3773
/JACQUELINE T JOHANAS/ Primary Patent Examiner, Art Unit 3773