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 .
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 4-7, 9-11, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lin (U.S. Patent No.5,702,391).
Regarding claim 1, Lin discloses an expandable implant comprising: a hollow dowel (10) extending along a central longitudinal axis (Figure 1), the dowel defining a center channel (where elements 31, 32, 33 and 40 reside therethrough) in fluid communication with a plurality of openings (where elements 20 reside therethrough); a plurality of moveable pins (20), each pin having an inner end (21) receivable in the center channel and an outer end configured to eject from a corresponding opening of the plurality of openings in the dowel (see portion of element 20 that extends out of tubular body 10 in Figure 5); and a central expansion key (31, 32, 33, 40) sized and dimensioned to fit within the center channel (Figures 1, 4 and 5), wherein movement of the central expansion key causes the pins to slidably and non-rotatably extend radially outward from the dowel (see the transition of the fusion device from Figure 4 to Figure 5).
Regarding claim 4, Lin further discloses where each pin (20) has a cylindrical body, and the outer end of each pin is conically shaped (see Figures 1, 4 and 5).
Regarding claim 5, Lin further discloses wherein the inner end of each pin (20) includes an enlarged rim to help retain the pin in the corresponding opening of the plurality of openings (holding means 21).
Regarding claim 6, Lin further discloses wherein the pins (20) are positioned perpendicular to the central longitudinal axis of the dowel (see Figures 1, 4 and 5).
Regarding claim 7, Lin further discloses wherein the pins (20) are arranged in a pattern around a periphery of the dowel (see Figures 2 and 3).
Regarding claim 9, Lin further discloses wherein in a retracted position, the pins (20) are retracted fully inside the dowel (Figure 4), and when the expansion key is translated distally, the pins are deployed radially outward and away from one another (Figure 5).
Regarding claim 10, Lin discloses an expandable implant comprising: an outer sleeve (10) extending along a central longitudinal axis (Figure 1), the outer sleeve defining a center channel (where elements 31, 32, 33 and 40 reside therethrough) in fluid communication with a plurality of openings (where elements 20 reside therethrough); a plurality of moveable teeth (20), each tooth having an inner end (21) receivable in the center channel and an outer end configured to eject from a corresponding opening of the plurality of openings in the outer sleeve (see portion of element 20 that extends out of tubular body 10 in Figure 5); and an inner shaft (31, 32, 33 and 40) sized and dimensioned to fit within the center channel (Figures 1, 4 and 5), wherein movement of the inner shaft along the center channel causes the teeth to slide along the center channel and extend radially outward from the outer sleeve (see the transition of the fusion device from Figure 4 to Figure 5).
Regarding claim 11, Lin further discloses wherein the outer sleeve is a polygonal pin (tubular body 10 has a hollow interior with a polygonal cross-section, see col.2, ll.1-6).
Regarding claim 14, Lin further discloses wherein the inner end of the teeth are attached to the inner shaft (conical ends of elements 20 contact elements 31, 32, 33 and 40, as shown in Figures 4 and 5).
Regarding claim 16, Lin further discloses wherein each tooth (20) includes a tapered section along an upper face of the tooth (see conical ends of elements 20 in Figures 4 and 5).
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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.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Lin, as applied to claim 1 above, in view of Trudeau (U.S. Publication No.2013/0053902 A1).
Regarding claim 2, Lin discloses the claimed invention as disclosed above, except for
wherein the distal end of the dowel has a conically narrowed distal tip to facilitate insertion into bone. However, Trudeau discloses a dowel (see element 600 as shown in Figures 19-23) having a distal end (602) to facilitate insertion into bone (para.0078). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lin’s element to have a conically narrowed distal tip, as taught by Trudeau, in order to facilitate insertion of the dowel into bone (see para.0078 of Trudeau).
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Regarding claim 3, Lin further discloses wherein the central expansion key (31, 32, 33, 40) has a cylindrical body (40) and extends from a proximal end to a distal end, the proximal end of the expansion key having an enlarged flange (threaded portion of element 40) configured to abut the proximal end of the dowel (threaded portion of element 40 engages threads of element 10 at the proximal end).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Lin, as applied to claim 1 above, in view of Champagne et al. (U.S. Publication No.2015/0094777 A1; hereinafter “Champagne”).
Regarding claim 8, Lin discloses the claimed invention as discussed above, except for wherein the pins are arranged in a pattern of six rows equidistantly positioned about an outer surface of the dowel. However, Champagne discloses a bone screw 400 having six blades 402- 412 attached to a shaft in order to facilitate cutting into bone (para.0027). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lin’s elements 20 to be arranged in a pattern of six rows equidistantly positioned about an outer surface of the dowel, as taught by Champagne (see blades 402-412 in Figure 4 of Champagne), in order to facilitate cutting into bone (see para.0027 of Champagne).
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Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Lin as applied to claim 10 above, in view of Koogle, Jr. (U.S. Patent No.8,870,877 B2; hereinafter "Koogle").
Regarding claims 12-13, Lin discloses the claimed invention as discussed above, except for wherein the polygonal pin is a hexahedron with six planar faces, and wherein the plurality of openings includes a single opening defined in each planar face for receiving the respective teeth. However, Koogle discloses a graft fixation device 1 comprising a sheath 2 that could have a hexagonal cross-section (col.12, 11.46-49). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Lin’s element 20 to be a hexahedron with six planar faces with an opening on each planar face, as taught by Koogle (see Figures 9a-9c of Koogle), in order to facilitate graft fixation (see col. 12, 11.46-49 of Koogle).
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Allowable Subject Matter
Claims 17-20 are allowed.
Claims 17-20 in the instant application have not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 17. In particular, none of the cited references teach or suggest a method of stabilizing a sacroiliac joint, including inserting an expandable anchor into the sacroiliac joint, inserting an expansion key through the body of the anchor to create a strong press-fit between the pins and the sacroiliac join, wherein the pins non-rotatably move from a first undeployed position to a second deployed position, as required by claim 17.
Claim 15 is 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.
Claim 15 in the instant application has not been rejected using prior art because no references, or reasonable combination thereof, could be found which disclose, or suggest, the claimed combination of limitations recited in independent claim 10 and claim 14 from which claim 15 depends from. In particular, none of the cited references teach or suggest, wherein when the inner shaft translates axially, the teeth flex or bend relative to the inner shaft, thereby causing the teeth to extend distally and radially outward, as required by claim 15.
Response to Arguments
Applicant’s arguments with respect to claims 1-14 and 16 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.
Conclusion
The prior art made of record and not relied upon, but considered pertinent to applicant's disclosure has been cited in the PTO-892 Notice of References Cited.
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 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 Christina Negrelli whose telephone number is 571-270-7389. The examiner can normally be reached on Monday-Friday, between 8:00am to 4:00pm. If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Eduardo Robert, at (571) 272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTINA NEGRELLI/
Examiner, Art Unit 3773
/EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773