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 .
Election/Restrictions
Applicant’s election without traverse of species 35 in the reply filed on 12/8/2025 is acknowledged.
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.
Claim(s) 1-5, 7-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Alleyne et al. (US pub 2005/0049590).
With respect to claim 1, Alleyne discloses an expandable, conforming implant (see figures 5B, 6B and 6G below show two embodiments that read on the claims) comprises: a frame (fig 5B, 30 or fig 6B, 60); a first plurality of bone-contacting segments (fig 5B, 38s on the left or fig 6, 67 and 68) that are each coupled to the frame and that are each configured to be independently vertically movable by a variable amount (independently moved by individual wedges) in at least one of: (i) a superior direction and (ii) an inferior direction (move into or out of the frame in both directions) with respect to the frame; and a locking mechanism (fig 5, 31 OR fig 6, 76) configured to selectively lock each of the first plurality of bone-contacting segments at a vertical position with respect to the frame such that a first bone-contacting segment and a second bone-contacting segment of the first plurality of bone-contacting segments can each be locked in a different vertical position with respect to the frame (threaded member locks the positioning). With respect to claim 2, Alleyne discloses further comprising a second plurality of bone-contacting segments (fig 5, 38s on the right or fig 6, 69, 70) that are each coupled to the frame and that are each configured to be independently movable in at least one of: (i) the superior direction and (ii) the inferior direction (in or out of the frame) with respect to the frame such that individual segments of the first plurality of bone-contacting segments are configured to conformingly contact and be locked in place to conform to an inferior endplate of a first vertebral body and such that individual segments of the second plurality of bone-contacting segments are configured to conformingly contact and be locked to conform to a superior endplate of a second vertebral body (fig 1). With respect to claim 3, Alleyne discloses wherein the frame defines an opening that is configured to receive an expansion mechanism (fig 5, 32and 33 or fig 6, 64 and 66) that is configured to apply at least one of: (i) an inferior-directed force and (ii) a superior-directed force to the first plurality of bone-contacting segments (wedge in both directions). With respect to claim 4, Alleyne discloses wherein the first plurality of bone-contacting segments comprises a coil pack construction (in figure 5 the segments are shown packed by coil springs). With respect to claim 5, Alleyne discloses wherein the locking mechanism is configured to selectively apply a compressive force to each of the first plurality of bone-contacting segments to lock the first plurality of bone-contacting segments in place with respect to the frame (threaded member translates into the frame causing the expansion members to apply a compressive force). With respect to claim 7, Alleyne discloses further comprising a cross web (fig 6, 72) that is disposed in the frame and that supports the first bone-contacting segment. With respect to claim 8, Alleyne discloses wherein the cross web comprises a projection (see fig 6G below) that extends into a corresponding elongated slot (See fig 6G below) defined by the frame.
9. The implant of claim 7, wherein the cross web defines an opening at its center and comprises bosses (fig 6D shows the openings formed with bosses) to receive and stabilize at least some of the first plurality of bone-contacting segments.
With respect to claim 10, Alleyne discloses an expandable, conforming interbody implant, comprising: a frame (fig 5, 30 or fig 6, 60); a first plurality of endplate-contacting segments (fig 5, 38s on the left fig 6, 67 and 68) that are configured to be vertically movable relative to one another and relative to the frame, wherein the first plurality of endplate-contacting segments are each configured to contact an inferior endplate of a first vertebral body (fig 1); a second plurality of endplate-contacting segments (fig 5, 38s on the right or fig 6, 69 and 70) that are configured to be vertically movable relative to one another and relative to the frame, wherein the second plurality of endplate-contacting segments are each configured to contact a superior endplate of a second vertebral body (fig 1) ; and a locking mechanism (see figs 5 or 6 below) that is configured to selectively lock each of the first plurality of endplate-contacting segments and the second plurality of endplate-contacting segments at respective vertical positions. With respect to claim 11, Alleyne discloses further comprising multiple cross webs (fig 6, 72s) that are each coupled to, and are configured when the locking mechanism is engaged to maintain a height of, a corresponding endplate-contacting segment. With respect to claim 12, Alleyne discloses further comprising a plate (see fig 5 below) configured to selectively move between a release position and a lock position, wherein when the plate is in the lock position, the plate sandwiches and locks the first plurality and second plurality of endplate- contacting segments in position, between the plate and a portion of the frame. With respect to claim 13, Alleyne discloses wherein the first plurality and the second plurality of endplate-contacting segments each comprise a coil pack construction (fig 5 the segments re packed inside of coil springs). With respect to claim 14, Alleyne discloses wherein when the first plurality and the second plurality of endplate-contacting segments are locked in place, the first plurality and the second plurality of endplate-contacting segments are configured to approximate an effective stiffness comparable to vertebral bone (paragraph 34 provide stable fixation). With respect to claim 15, Alleyne discloses wherein the locking mechanism is selectively releasable to permit repositioning of at least one of the first plurality of endplate-contacting segments (can be unthread). With respect to claim 16, Alleyne discloses wherein the locking mechanism comprises a threaded locking mechanism (fig 5, 31) that is configured compress the first plurality of endplate-contacting segments together to lock them in place.
With respect to claim 17, Alleyne discloses a method for using an expandable, conforming implant (fig 1), the method comprising: placing an expandable, conforming implant in a patient between a first bony surface (Fig 1, 14) and a second bony surface (fig 1, 15), wherein the expandable, conforming implant (see figures 5B, 6B and 6G below show two embodiments that read on the claims) comprises: a frame (fig 5B, 30 or fig 6B, 60); a first plurality of bone-contacting segments (fig 5B, 38s on the left or fig 6, 67 and 68) that are each coupled to the frame and that are each configured to be independently vertically movable by a variable amount (independently moved by individual wedges) in at least one of: (i) a superior direction and (ii) an inferior direction (move into or out of the frame in both directions) with respect to the frame; and a locking mechanism (fig 5, 31 OR fig 6, 76) configured to selectively lock each of the first plurality of bone-contacting segments at a vertical position with respect to the frame such that a first bone-contacting segment and a second bone-contacting segment of the first plurality of bone-contacting segments can each be locked in a different vertical position with respect to the frame (threaded member locks the positioning); supplying a force (fig 5B to 5C or fig 6E to 6F) to cause at least some of the first plurality of bone-contacting segments to conform to the first bony surface; and engaging the locking mechanism (threaded member) to lock the first plurality of bone-contacting segments in place. With respect to claim 19, Alleyne discloses wherein the expandable, conforming implant further comprises a second plurality of bone-contacting segments (fig 5B, 38 right or fig 6G, 69 and 70) that are each coupled to the frame and that are each configured to be independently vertically movable by in the at least one of: (i) the superior direction and (ii) the inferior direction with respect to the frame (in and out of the frame), and wherein the method further comprises causing at least some of the second plurality of bone-contacting segments to conform to the second bony surface (fig 1 With respect to claim 20, Alleyne discloses wherein the engaging the locking mechanism comprises tightening a threaded member into the frame to compress the first plurality of bone-contacting segments together (fig 5B, 31 and paragraph 34).
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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.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alleyne et al. (US pub 2005/0049590) in view of Reo et al. (US Pub 2007/0050033).
With respect to claim 18, Alleyne discloses the method of expanding the segments with a spacer (fig 5, 33) and discloses other means can be used to expand the segments (paragraph 33) to cause expansion of the segments (paragraph 33) but does not disclose inserting an inflatable bladder into the expandable, conforming implant to supply the force to cause the at least some of the first plurality of bone-contacting segments to conform to the first bony surface.
Reo discloses both using a spacer to expand the segments (paragraph 159) and discloses inserting an inflatable bladder (paragraph 159) into the expandable, conforming implant to supply the force (paragraph 159. Expansion balloon) to cause the at least some of the first plurality of bone-contacting segments (expanded to cause retractable fins (segments) to be deployed) to conform to the first bony surface to cause expansion of the segment (paragraph 159).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to substitute spacer of Alleyne with the inserting an inflatable bladder into the expandable, conforming implant to supply the force to cause the at least some of the first plurality of bone-contacting segments to conform to the first bony surface in view of Reo because a spacer and the inserting an inflatable bladder into the expandable, conforming implant to supply the force to cause the at least some of the first plurality of bone-contacting segments to conform to the first bony surface are mere functional equivalents, and because such a substitution of one for the other would have achieved the same predicable result of causing expansion of the segment.
Allowable Subject Matter
Claim 6 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 20130197647 A1 discloses an implant with expandable segments
US 20120046748 A1 discloses an implant with expandable segments
US 20130304211 A1 discloses an implant with expandable segments
US 20060095136 A1 discloses an implant with expandable segments
US 20120303124 A1 discloses an implant with expandable segments
US 9414934 B2 discloses an implant with expandable segments
US 9532883 B2 discloses an implant with expandable segments
US 5123926 A discloses an implant with expandable segments
US 9937050 B2 discloses an implant with expandable segments
US 10219914 B2 discloses an implant with expandable segments
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/S.J.C/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773