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 .
Response to Arguments
Applicant's arguments filed 02/20/26 have been fully considered but they are not persuasive.
On page 23 Applicant argues amendments to the specification overcome drawing objections.
The Examiner respectfully agrees many drawing objections have been overcome, but notes not all were overcome. These are accordingly maintained.
On pages 23-24 regarding prior art rejections Applicant argues amendments overcome the rejection of record.
The Examiner respectfully refers to the rejection below regarding amended claims.
Drawings
The drawings are objected to because:
-item 14 stands for “helical threads”, “helix”
-item 44 stands for “screw thread”, “exterior thread”
-item 102 is used to represent “central screw”, “main body”
-item 112 is used to represent “shaft”, “screw shank”
-in figure 6a, item 166 appears to be pointing to two distinct items, 2 graft windows in section 160, and something else in section 158
-item 140 is used to represent “implant”, and “sacroiliac joint screw”
-item 176 is used to represent both “expandable collar” and “screw head”
-item 254 is used to represent “screw”, “shaft”, “inner driving screw”, and “internal screw”
-item “270” and “254” are both used to represent shaft
-item 366 is used to represent “latticed areas”, “lattice structure”, “lattice”, and “latticed flute areas”
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 19-20 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 pre-AIA the applicant regards as the invention.
Claims 19-20 are indefinite for referring to there being a “helical or spiral sweep” but it is unclear what a “sweep” is. Merriam-Webster appears to define “sweep” as “something that sweeps or works with a sweeping motion; an instance of sweeping; a movement of great range and force”. None of these definitions appear to relate to anything shown in the figures or described by the specification, particularly in relation to something being spiral.
Claim 20 is further indefinite for referring to “the helical or spiral sweep” since it is unclear what this is referring to, since claims 16, 15, and 12, from which this depends, has nothing with a spiral sweep.
Remaining claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 7, 12-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lindsey et al. (US 20190298528 A1) hereinafter known as Lindsey.
Regarding claim 1 Lindsey discloses a method for stabilizing a sacroiliac joint ([0003]-[0004]) comprising:
providing an implant having an outer cage (Figure 15 item 362) with a polygonal cross-section (Figure 17; triangular cross-section) and an internal screw aligned along a central longitudinal axis (Figure 16 item 350, which shows axis along cannulation 366), wherein the outer cage is free to rotate about the axis relative to the screw to allow for minimal displacement of patient tissue ([0069]);
accessing an ilium of a patient ([0005], [0086]), and
inserting the implant across the joint such that once the implant is fully seated, the outer cage acts as a stop to prevent rotational motion of the implant ([0069]),
wherein the internal screw has a plurality of threaded sections (Annotated Figure 14) and a plurality of narrowed sections (Annotated Figure 14),
each of the narrowed sections separating two of the plurality of threaded sections (Annotated Figure 14).
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Regarding claim 2 Lindsey discloses the method of claim 1 substantially as is claimed,
wherein Lindsey further discloses inserting multiple implants across the joint to better stabilize and prevent movement of the joint ([0005] multiple implants; see also Figures 8-9).
Regarding claim 7 Lindsey discloses the method of claim 1 substantially as is claimed,
wherein Lindsey further discloses the three faces are planar (Figure 17 shows cage 362 with three planar faces).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindsey as is applied above in view of Crawford et al. (US 10675094 B2) hereinafter known as Crawford.
Regarding claim 3 Lindsey discloses the method of claim 1 substantially as is claimed,
but is silent with regards to whether the joint is accessed with a robotic and navigational system.
However, regarding claim 3 Crawford teaches that orthopedic surgeries can occur with a robotic and navigational system (Abstract). Lindsey and Crawford are involved in the same field of endeavor, namely orthopedic surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Lindsey by utilizing a robotic and navigational system as is taught by Crawford in order to aid the surgeon implanting the implant so they have the safety and convenience of an image-guided implantation.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindsey as is applied above in view of Appenzeller et al. (KR 20150126633 A) hereinafter known as Appenzeller.
Regarding claim 12 Lindsey discloses a method for stabilizing a sacroiliac joint ([0003]-[0004]) comprising:
providing an implant comprising an outer cage (Figure 15 item 362) and an internal screw aligned along a central longitudinal axis (Figure 16 item 350, which shows axis along cannulation 366), the outer cage having a polygonal outer shape (Figure 15 item 362) and is configured to limit rotational motion ([0069]), wherein the screw is sized and dimensioned to fit through the outer cage (Figures 14, 16), and has an enlarged head (Figure 15 item 358) and shaft (Figure 15) with a plurality of threaded sections (Figure 15 item 360 and 358), wherein the cage is free to rotate relative to the screw ([0069]),
positioning the implant in the joint ([0003], [0005]),
but is silent with regards to the internal screw having a plurality of narrowed shaft portions, each of the plurality of narrowed shaft portions being disposed between two of the plurality of threaded sections.
However, regarding claim 12 Appenzeller teaches a bone screw that includes a plurality of narrowed shaft portions, each of the plurality of narrowed shaft portions being disposed between two of the plurality of threaded sections (Annotated Figure 1). Lindsey and Appenzeller are involved in the same field of endeavor, namely bone screws. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of Lindsey so that the internal screw has both a plurality of narrowed shaft portions separating threaded sections as is taught by Appenzeller in order to allow for cutting the screw at various spots and giving an adjustable length bone screw, thus allowing the surgeon more flexibility in use of the screw for different patients.
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Regarding claim 13 the Lindsey Appenzeller Combination teaches the method of claim 12 substantially as is claimed,
wherein Lindsey further discloses the cage has a triangular cross-section (Figure 17).
Regarding claim 14 the Lindsey Appenzeller Combination teaches the method of claim 12 substantially as is claimed,
wherein Lindsey further discloses the cage includes three faces and three vertices (Figure 17 shows cage 362 with three flat faces and three vertices in the corners).
Regarding claim 15 the Lindsey Appenzeller Combination teaches the method of claim 12 substantially as is claimed,
wherein Lindsey further discloses the cage defines corresponding narrowed sections (Figure 16 shows cage 362 with corresponding portions that are narrower than its outer cross-section where it engages with the shaft) configured to mate with one of the narrowed shaft portions (Figure 16), wherein the narrowed shaft portions act as stops to prevent the cage from translating along the axis ([0069], Figure 16 shows how the narrowed portions prevent the cage from translating proximally).
Regarding claim 16 the Lindsey Appenzeller Combination teaches the method of claim 15 substantially as is claimed,
wherein Lindsey further discloses the narrowed shaft portions are non-threaded and have a reduced diameter relative to the threaded sections (Figures 15-16).
Claim 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindsey and Appenzeller as is applied above, further in view of Schifano et al. (US 20230076180 A1) hereinafter known as Schifano.
Regarding claim 18 the Lindsey Appenzeller Combination teaches the method of claim 12 substantially as is claimed,
but is silent with regards to the cage including one or more prongs extending distally.
However, regarding claim 18 Schifano teaches a bone cage that includes one or more prongs extending distally from the cage (Figures 56-57 items 503-504). Lindsey and Schifano are involved in the same field of endeavor, namely orthopedic surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Lindsey Appenzeller Combination by including prongs on the cage as taught by Schifano in order to enable the cage to penetrate bone tissue which will further act as an anchor during implantation, thus increasing stability.
Claim 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindsey and Appenzeller as is applied above, further in view of Gladieux et al. (US 20230389970 A1) hereinafter known as Gladieux.
Regarding claim 19 the Lindsey Appenzeller Combination teaches the method of claim 12 substantially as is claimed,
but is silent with regards to the implant including a helical or spiral sweep interrupting the threaded sections.
However, regarding claim 19 Gladieux teaches a bone screw can include a helical or spiral sweep which interrupts the threaded sections (Figure 1 item 30 ). Lindsey and Gladieux are involved in the same field of endeavor, namely orthopedic surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Lindsey Appenzeller Combination by including a helical or spiral sweep as is taught by Gladieux in order to act as a location where bone material that has been removed/displaced can accumulate during implantation of the implant.
Claim 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lindsey and Appenzeller as is applied above, further in view of Huffman et al. (US 20240115296 A1) hereinafter known as Huffman.
Regarding claim 20 Lindsey discloses the method of claim 16 substantially as is claimed,
but is silent with regards to a helical or spiral sweep including a lattice structure.
However, regarding claim 20, Huffman teaches a bone screw can include a helical or spiral sweep with a lattice structure (Figure 5 item 280). Lindsey and Huffman are involved in the same field of endeavor, namely orthopedic surgery. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the method of the Lindsey Appenzeller Combination by including a spiral sweep with lattice structure as is taught by Huffman in order to encourage bone growth therethrough, thus encouraging fixation and ingrowth after implantation.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 03/02/26