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 § 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.
Claim 24 is 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 24 recites the limitation "wherein insertion of the support member" in line 1. It is unclear as to where “insertion of the support member” is taking place (i.e. within the expandable frame, within the collapsed configuration, the expanded configuration, etc.).
Appropriate corrections are required.
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 21-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Glerum et al. (U.S. Publication No.2014/0094916 A1; hereinafter “Glerum”) .
Regarding claim 21, Glerum discloses an intervertebral implant (see the embodiment disclosed in Figure 58) comprising: an expandable frame (upper and lower endplates 480, 485) movable from a collapsed configuration (Figure 64A) to an expanded configuration (Figure 64B); a support member (actuator assembly 445 comprising a front sloped height actuator 450, a rear sloped height actuator 455, and a linear actuator 460) receivable within the expandable frame (Figure 58); and an expansion-control member (endplate pins 515) coupled to the expandable frame and configured to establish a maximum expanded condition of the expandable frame independently of the support member (para.0176).
Regarding claim 22, Glerum further discloses wherein the expansion-control member (pins 515) is flexible (pins 515 allow for alterations of fusion device as they provide for even and simultaneous movement of endplate portions, see para.0167).
Regarding claim 23, Glerum further discloses wherein the expansion-control member (515) extends between opposite sides of the expandable frame (Figure 58).
Regarding claim 24, Glerum further discloses wherein insertion of the support member (445) does not alter a maximum expansion dimension established by the expansion-control member (the linear actuator 460 functions to pull the front sloped actuator 450 and the rear sloped actuator 455 together, which forces apart the upper endplate 480 and lower endplate 485, but does not affect the maximum expansion dimension defined by pins 515, see para.0160).
Regarding claim 25, Glerum further discloses wherein the expandable frame is configured to expand laterally and vertically (Figures 64A, 64B).
Regarding claim 26, Glerum further discloses wherein the expandable frame defines a first footprint in a delivery configuration (Figure 64A) and a second footprint in an implanted configuration (Figure 64B), the second footprint being larger than the first footprint (see Figures 64A, 64B).
Regarding claim 27, Glerum further discloses wherein the support member (445) defines one or more passages configured to receive graft material (see the space between extension 475 which coincides with bone graft hole 520, as shown in Figure 60).
Regarding claim 28, Glerum further discloses wherein the expansion-control member (515) is configured to limit expansion of the expandable frame before insertion of the support member (para.0167).
Regarding claim 29, Glerum discloses an intervertebral implant (see the embodiment disclosed in Figure 58) comprising: an expandable frame (upper and lower endplates 480, 485) movable from a collapsed configuration (Figure 64A) to an expanded configuration (Figure 64B); a stabilizer (endplate pins 515) coupled to a first portion (480) and a second portion (485) of the expandable frame and configured to limit expansion of the expandable frame beyond the expanded configuration (para.0176); and a support member (actuator assembly 445 comprising a front sloped height actuator 450, a rear sloped height actuator 455, and a linear actuator 460) receivable within the expandable frame (Figure 58); wherein the stabilizer is separate from the support member (Figure 58).
Regarding claim 30, Glerum further discloses wherein the stabilizer (515) extends across an interior region of the expandable frame (Figure 58).
Regarding claim 31, Glerum further discloses wherein the stabilizer (515) is coupled to opposing distal regions of the expandable frame (Figure 58).
Regarding claim 32, Glerum further discloses wherein the stabilizer (515) is configured to become tensioned during expansion of the expandable frame (para.0167).
Regarding claim 33, Glerum further discloses wherein the support member (445) is insertable after the expandable frame has reached the expanded configuration (“As the linear actuator 460 is rotated in a first direction, the actuator assembly 445 pulls the front sloped actuator 450 towards the rear sloped actuator 455 and consequently also towards the head portion 465 of the linear actuator 460 in a linear direction. As the front sloped actuator 450 is pulled towards the rear sloped actuator 455, the sloped surfaces 454, 459 respectively, of the front sloped actuator 450 and the rear sloped 455 actuator push the upper 480 and lower 485 endplates outwardly into the expanded position”, see end of para.0161).
Regarding claim 34, Glerum further discloses wherein the support member (445) increases rigidity of the expandable frame without defining a maximum expansion dimension of the expandable frame (actuator assembly 445 keeps endplates aligned, “As the linear actuator 460 is rotated in a first direction, the actuator assembly 445 pulls the front sloped actuator 450 towards the rear sloped actuator 455 and consequently also towards the head portion 465 of the linear actuator 460 in a linear direction. As the front sloped actuator 450 is pulled towards the rear sloped actuator 455, the sloped surfaces 454, 459 respectively, of the front sloped actuator 450 and the rear sloped 455 actuator push the upper 480 and lower 485 endplates outwardly into the expanded position”, see end of para.0161).
Regarding claim 35, Glerum further discloses wherein expansion of the expandable frame creates at least one graft-receiving opening (see the space between extension 475 which coincides with bone graft hole 520, as shown in Figure 60).
Regarding claim 36, Glerum discloses a method of implanting an intervertebral device (see the embodiment disclosed in Figure 58), comprising: inserting an expandable frame (upper and lower endplates 480, 485) into an intervertebral disc space in a collapsed configuration (Figure 64A); expanding the expandable frame within the intervertebral disc space (Figure 64B); limiting expansion of the expandable frame with a stabilizer (endplate pins 515) coupled to the expandable frame (Figure 58); and inserting a support member (actuator assembly 445 comprising a front sloped height actuator 450, a rear sloped height actuator 455, and a linear actuator 460) into the expandable frame after expansion (see method disclosed in para.0169-170); wherein the stabilizer is separate from the support member (Figure 58).
Regarding claim 37, Glerum further discloses wherein the stabilizer (515) becomes tensioned during expansion of the expandable frame (para.0167).
Regarding claim 38, Glerum further discloses wherein limiting expansion of the expandable frame occurs before insertion of the support member (para.0169-0170).
Regarding claim 39, Glerum further discloses inserting graft material through one or more openings defined by the support member (see bone graft hole 520 in Figure 60).
Regarding claim 40, Glerum further discloses wherein the expandable frame (480, 485) expands to a footprint (Figure 64B) larger than an insertion footprint (Figure 64A) used to introduce the expandable frame into the intervertebral disc space (Figures 64A, 64B).
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Conclusion
The prior art made of record and not relied upon but considered pertinent to applicant's disclosure is listed in the PTO-892 Notice of References Cited.
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
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