DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 13, 18, 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-14 of U.S. Patent No. 11672574B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 13 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-12 of U.S. Patent No. 11672574B2. Pat. No. ‘574 recites a method for fusing a sacroiliac joint by providing an implant with a body and two stabilizers [Claim 11 col. 12 line 54 to col. 13 line 2 ], providing a drill guide having a tube, a central guide hole, and a non-centered guide hole [Claim 11 col. 12 lines 19-32], inserting said drill guide into the sacroiliac joint such that the non-centered guide hole is aligned with one of the ilium and sacrum [Claim 11 col. 12 lines 33-37], inserting a drill into said central/ guide hole of said drill guide and drilling a hole and inserting a drill into the non-centered guide hole and drilling [Claim 11 col. 12 lines 38-43], removing the drill guide from the joint and rotating 180 degrees an reinserting into the joint and inserting a drill into the non-centered guide hole [Claim 11 col. 12 lines 44-51], the holes that are drilled into the sacrum and ilium combine to form a cavity sized to receive said body of said implant [claim12]; inserting the implant into said cavity [claim 11 col 13 line 3-21].
Claims 21-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-14 of U.S. Patent No. 11672574B2 because they recite substantially similar limitations.
Claim Objections
Claim 1 objected to because of the following informalities: the limitation recites in line 21-22 “said central guide hole sized to receive a drill bit” which is believed should recite “said non-centered guide hole sized to receive a drill bit”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 7, 9, 13-19, 21-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 is rejected as indefinite for the recitation of “a drill bit” in lines 17 and 22 and “a drill” in lines 29 and 36. It is unclear if these recitations are meant to be referring to the same drill bit and drill or to a new drill bit and drill. In the interest in compact prosecution the limitation will be interpreted as a further clarification of the same drill bit and drill.
Claims 3, 7, 9, 14-19, and 21-27 are rejected as indefinite for depending upon an indefinite claim.
Claim Rejections - 35 USC § 103
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 of this title, 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 negatived by the manner in which the invention was made.
Claim 3, 7, 9, 13-19 and 21-27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Vestgaarden (US Patent Pub. 20090036927A1) in view of Stark (Patent Pub. 2009/0216238 A1) and Michelson (US Patent Pub. 20010010002A1).
Vestgaarden recites a method. Specifically in regards to claim 13, Vestgaarden recites providing an implant (5) comprising: a body (10) having a distal end, a proximal end, and top and bottom surfaces (surfaces with 15); a first stabilizer (15) extending outwardly from said top surface of said body (10), and a second stabilizer (15) extending outwardly from said bottom surface of said body (10), said first and second stabilizers (15) being diametrically opposed from one another (Fig. 1; and Para. [0054]-[0056] and claim 29). Vestgaarden recites providing a drill guide (115) comprising: a tube having a distal end and a proximal end; a non-centered guide hole ( hole shown in Fig. 9) extending between said proximal end of said tube of said drill guide (115) and said distal end of said tube of said drill guide (115), and said non-central guide hole being sized to receive a drill bit (135, Fig. 20); inserting said drill guide (115) into the joint such that said non-centered guide hole is aligned with one of the first and second bones (Vestgaarden recites that the implant 5 may be used to stabilize and fuse any joint having anatomy similar to the facet joint, i.e., a pair of opposing bony surfaces defining a gap therebetween.) (Fig. 9, 19-20; and Para. [0073],[0099]). Inserting a drill (135) into said non-centered guide hole of said drill guide (115) and drilling a hole into one of the first and second bones; removing said drill guide (115) from said joint, rotating said drill guide (115) 180°, and inserting said rotated drill guide (115) into said joint such that said non-centered guide hole is aligned with the other of the first and second bones; and inserting a drill (135) into said non-centered guide hole of said drill guide (115) and drilling a hole into the other of the first and second bones (Fig. 9 and 19-20; and Para. [0073]). Vestgaarden recites wherein the holes that are drilled into the joint combine to form a cavity (45) sized to receive said body of said implant (5); and inserting said implant (5) into said cavity (45) such that a portion of said body (10) of said implant (5) contacts the first bone and a portion of the said body (10) contacts the second bone, and said first and second stabilizers (15) of said implant (5) are disposed in the space between the bones, such that the first and second stabilizers (15) extend parallel to the joint line (Fig. 4-5; and Para. [0060]-[0063]). However, the reference is silent as to the method being performed on a sacroiliac joint, or providing a drill guide with a central hole.
Stark recites a method for fusing a sacroiliac joint (tools for performing less invasive orthopedic procedures). Specifically in regards to claim 13, Stark recites forming an opening in the sacroiliac joint (104) such that a portion of the opening is formed in the iliac bone (102) and a portion of the opening is formed in the sacrum (100); and inserting an implant into said opening such that a portion of said body of said implant contacts both the iliac and sacrum bones and the implant is divided by a joint line (Stark recites that the joint is exposed then portions of both the ilium and sacrum are drilled and/or cut away to create a recess for the immobilization device to be placed as seen in Fig. 3 which spans the ilium and sacrum bones. Stark recites that the cannulae used engage the joint in a shifted configuration so that the surgeon can control how much is drilled into the ilium and sacrum.) (Fig.1-2 and 21-26; and Page 2 Para. [0040], Page 4 Para. [0054], Page 9 Para. [0100], Page 10 Para. [0101] and [0105]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Vestgaarden to have the implant used in a sacroiliac joint as taught in Stark since it has been contemplated that the implant may be used to stabilize and fuse any joint having anatomy similar to the facet joint, i.e., a pair of opposing bony surfaces defining a gap therebetween, with the stabilizer of the fusion implant being sized to be positioned within the gap (Vestgaarden Para. [0099]). However, the references are still silent as to the providing of a drill guide with a central hole.
Michelson recites a method. Specifically in regards to claim 13, Michelson recites providing a drill guide comprising a tube (196) having a distal end and a proximal end (end with 200), said tube (196) being sized to be received in said lumen of said directional cannula (170); a central guide hole (192) extending between said proximal end of said tube (196) of said drill guide (190) and said distal end of said tube (196) of said drill guide (190), said central guide hole (192) being sized to receive a drill bit (210); an non-centered guide hole (194) extending between said proximal end of said tube (196) of said drill guide (190) and said distal end of said tube (196) of said drill guide (190), said non-centered guide hole (194) extending parallel to said central guide hole (192) and said non-central guide hole (194) being sized to receive a drill bit (230); inserting said drill guide (190) into said directional cannula (170) such that said central guide hole (192) of said drill guide (190) is aligned with the surgical site, and such that said non-centered guide hole (194) is aligned with one of the first and second bones; inserting a drill (210) into said central guide hole (192) of said drill guide (190) and drilling a hole into a portion of the first and second bones; inserting a drill (230) into said non-centered guide hole (194) of said drill guide (190) and drilling a hole into one of the first and second bones; removing said drill guide (190) from said directional cannula (170), rotating said drill guide 180°, and inserting said rotated drill guide (190) into said directional cannula (170) such that said non-centered guide hole (194) is aligned with the other of the first and second bones; and inserting a drill (230) into said non-centered guide hole (194) of said drill guide (190) and drilling a hole into the other of the first and second bones (Fig. 14-18; and Para. [0100]-[0105]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the combination by modifying the drill guide (115) of Vestgaarden to have both the centered and non-centered holes as taught in Michelson in order to have a guide that forms first and second hole patterns (Para. [0013]).
In regards to claim 3, Vestgaarden in view of Stark and Michelson disclose a method of fusing a sacroiliac joint. Stark further recites retracting soft tissue to expose the sacroiliac joint (Para. [0075]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Vestgaarden to have the implant used in a sacroiliac joint as taught in Stark since it has been contemplated that the implant may be used to stabilize and fuse any joint having anatomy similar to the facet joint, i.e., a pair of opposing bony surfaces defining a gap therebetween, with the stabilizer of the fusion implant being sized to be positioned within the gap (Vestgaarden Para. [0099]).
In regards to claim 7, Vestgaarden recites wherein the implant (5) comprises a bone growth promoter (Para. [0089],[0099]).
In regards to claim 9, Vestgaarden in view of Stark and Michelson disclose a method of fusing a sacroiliac joint. Stark further recites inserting a joint locator (sharp pin 510) into the sacroiliac joint (104) until a distal end of said joint locator (sharp pin 510) engages the sacroiliac joint (104) so that a joint locator blade (tip 512) distally located on said joint locator (sharp pin 510) aligns in the sacroiliac joint (104) (Page 10 Para. [0103], and Page 3 Para. [0047]); abrading sacroiliac joint (104) surfaces using said joint locator blade (tip 512) (Stark recites that once the blunt pin is used to determine the location of the SI joint then it can be replaced by a sharp pin which due to its sharp distal tip will inherently cause some scrapping, or abrasions, to the joint surface as it enters into its final position.). Stark also recites sliding a directional cannula over said joint locator (sharp pin 510) until a distal end of said directional cannula engages the sacroiliac joint (104) so that alignment teeth distally located on said directional cannula align in the sacroiliac joint (104) (Page 2 Para. [0040], Page 3 Para. [0045] and [0047]), and removing said joint finder (sharp pin 510) from a lumen of said directional cannula (Page 3 Para. [0047]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Vestgaarden to utilize a joint locator as taught in Stark in order to ensure proper placement of the series of cannulated instruments (Para. [0047]).
In regards to claim 14, Vestgaarden recites wherein said body (10) of said implant (5) comprises a non-circular cross-section (Fig. 1).
In regards to claim 15, Vestgaarden recites wherein said body (10) of said implant (5) comprises an ovoid cross-section (Fig. 1).
In regards to claim 16, Vestgaarden recites wherein said first stabilizer (15) comprises a distal end and a proximal end, said second stabilizer (15) comprises a distal end (20) and a proximal end, and further wherein at least one of said distal end (20) of said first and second stabilizers is chamfered (Fig. 1).
In regards to claim 17, Vestgaarden recites wherein said distal end (20) of said body (10) of said implant (5) is chamfered, and further wherein said chamfered distal end (20) of said body (10) of said implant (5) is aligned coincident with said chamfered distal end (20) of at least one of said first and second stabilizers (15) (Fig. 1; and Para. [0055]).
In regards to claim 18, Vestgaarden recites providing a directional cannula (110) for receiving the drill guide, the directional cannula comprising: a tube having a distal end (end with teeth), a proximal end, and a lumen extending therebetween; a pair of alignment teeth disposed at said distal end of said tube of said directional cannula (110); and inserting said alignment teeth of said directional cannula into the joint until said distal end of said tube of said directional cannula engages the ilium and the sacrum (If the method of Vestgaarden were to be modified by the Stark reference then the joint into which the cannula 110 is inserted would be the sacroiliac joint.) (Fig. 8 and 16; and Para. [0069],[0072]-[0073]).
In regards to claim 19, Vestgaarden in view of Stark recite a method as recited above. Michelson further recites wherein said drill guide (190) is inserted into said directional cannula (170) such that said central guide hole (192) of said drill guide (190) is aligned with the surgical site, and such that said non-centered guide hole (194) is aligned with one of the first and second bones (Fig. 14-18; and Para. [0100]-[0105]). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the combination by modifying the drill guide (115) of Vestgaarden to have both the centered and non-centered holes as taught in Michelson in order to have a guide that forms first and second hole patterns (Para. [0013]).
In regards to claim 21, Vestgaarden recites wherein said body (10) of said implant (5) is sized to be slightly larger than said cavity (5) formed in the bones, such that said body (10) of said implant (5) makes a press fit with the bones when said implant (5) is inserted into said cavity (45) (If the method of Vestgaarden were to be modified by the Stark reference then the joint into which the cannula 110 is inserted would be the sacroiliac joint.) (Fig. 4-5; and Para. [0056],[0063]).
In regards to claim 22, Vestgaarden recites wherein said implant (5) is countersunk in said cavity (45) (Fig. 4-5; and Para. [0075]).
In regards to claim 23, Vestgaarden recites wherein said body (10) of said implant (5) comprises a cross-sectional profile characterized by a primary axis and a secondary axis, and further wherein said first and second stabilizers (15) extend outwardly from said top and bottom surface of said body (10), respectively, parallel to said secondary axis (Fig. 1; and Para. [0040]).
In regards to claim 24, Vestgaarden recites wherein the width of said first and second stabilizers (15) measured along said primary axis is sized to make a press fit into the gap between the bones (If the method of Vestgaarden were to be modified by the Stark reference then the joint into which the cannula 110 is inserted would be the sacroiliac joint.) (Fig. 1; and Para. [0014],[0056],[0063]).
In regards to claim 25, Vestgaarden recites wherein said opening (45) formed in the joint is formed using a posterior approach, and further wherein said implant (5) is inserted into said opening using a posterior approach (Fig. 4-5; and Para. [0059]).
In regards to claim 26, Vestgaarden recites wherein said portion of said cavity (45) formed in the first bone is substantially one half of said cavity (45), and said portion of said cavity (45) formed in the second bone is substantially one half of said cavity (45) (If the method of Vestgaarden were to be modified by the Stark reference then the joint into which the cannula 110 is inserted would be the sacroiliac joint.) (Fig. 4-5).
In regards to claim 27, Vestgaarden in view of Stark and Michelson disclose a method of fusing a sacroiliac joint. Stark further recites sliding a cannulate reamer (420) over said joint locator (510) until a distal end of said reamer (420) engages the sacroiliac joint and creating a horizontal graft site (Fig. 25; and Para. [0079],[0081],[0106]).
Response to Arguments
Applicant's arguments filed 11/12/25 have been fully considered but they are not persuasive. Applicant argues that the Stark reference only teaches that it is known in the art that to prepare a seat in the sacroiliac joint and does not teach drilling holes into each of the sacrum and iliac to form a cavity to accept an implant therein with diametrically opposed stabilizers and Vestgaarden teaches stabilizing a facet joint not a sacroiliac joint (Remarks Pg. 10-13). To begin applicant’s interpretation of Vestgaarden is incorrect. In Vestgaarden in the specification at paragraph [0099] it is recited that “[w]hile fusion implant 5 has been discussed above in the context of fusing a facet joint, it should also be appreciated that fusion implant 5 may be used to stabilize and fuse any joint having anatomy similar to the facet joint, i.e., a pair of opposing bony surfaces defining a gap therebetween, with the stabilizer of the fusion implant being sized to be positioned within the gap.” This would lead a person of ordinary skill in the art to look to the use of the implant in other joints whose gaps are created by two bony surfaces face each other such as the sacroiliac joint. Therefore, the method described in Vestgaarden can be used to fuse other joint such as the fusion of the sacroiliac joint as recited in the Stark reference. Therefore, the Stark reference was brought in to show that it was known at the time that it could be fused to fill in the missing gaps of the Vestgaarden reference.
As to the drill guide not having a central hole as now required in the claim (Remarks Pg. 13-14), the Michelson reference was brought in to demonstrate that this was also well known at the time of the invention. The Michelson reference does not need to disclose a fusion of the sacroiliac joint since the combination of the Vestgaarden and Stark references as disclosed above render those limitations obvious.
Therefore, the continued rejections of the claims is proper.
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 MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775