DETAILED ACTION
Terminal Disclaimer
The terminal disclaimer filed on August 3, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,156,819 has been reviewed and is accepted. The terminal disclaimer has been recorded, and the double patenting rejection has been withdrawn.
Claim Rejections - 35 USC § 103
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 18-22 and 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2004/0193158 (Lim) U.S. Patent Application Publication No. 2015/0018951 (Loebl).
Regarding claim 18, Lim discloses an expandable interbody fusion device (10) adapted to be implanted into an intervertebral disc space in a patient’s body (see Abstract), comprising; a first base plate (upper plate 50, see Figs. 1 and 2) having a first outer bearing surface (52) configured to interface with a first vertebra of the intervertebral disc space (see Abstract and paragraph [0028]); a second base plate (lower plate 50, see Figs. 1 and 2) having a second outer bearing surface (52) configured to interface with a second vertebra of the intervertebral disc space (see Abstract and paragraph [0028]); only two arm assemblies (each arm assembly comprises a pair of linkages 40, and “[i]n another embodiment (not illustrated), spacer 10 includes only two pairs of linkages 40, or four total linkages”, see paragraph [0025]), wherein a first of the two arm assemblies is arranged on a first side of the device and a second of the two arm assemblies is arranged on a second side of the device (see paragraph [0025], “[i]n another embodiment (not illustrated), spacer 10 includes only two pairs of linkages 40, or four total linkages”; in a device with only two arm assemblies, it would be obvious for the two arm assemblies to be arranged on opposite first and second sides of the device to allow for even distribution of load and symmetrical movement of the plates relative to each other), wherein each of the only two arm assemblies comprises only a first rigid member (one of linkages 40 in a pair; see paragraph [0025]) and a second rigid member (another of linkages 40 in a pair; see paragraph [0025]) that pivot with respect to one or more of the first base plate and the second base plate (see paragraph [0032] and Figs. 1 and 2; pivoting about a pin 61 or 62, e.g.); and wherein movement of the arm assemblies causes the first outer bearing surface and the second outer bearing surface to separate (see Figs. 1 and 2 and paragraphs [0038] and [0039]).
Further regarding claim 18, Lim is silent on the device 10 having movement of the arm assemblies causing the first outer bearing surface and the second outer bearing surface be angled relative to one another. However, Loebl discloses an intervertebral spinal device (10) wherein an expansion of an arm assembly (26) causes first and second base plates (12/20) and their respective bearing surfaces to be angled relative to one another (see Figs. 4A-4C). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the device of Lim to have angled bearing surfaces upon expansion of the arm assemblies as suggested by Loebl in order to facilitate restoration of a desirable degree of lordosis (see paragraph [0062], e.g.).
Regarding claim 19, Lim discloses wherein when the arm assemblies are in a contracted configuration the first outer bearing surface and the second outer bearing surface are parallel with each other (see paragraph [0033]).
Regarding claim 20, Lim discloses further comprising a first block (34) disposed between the first base plate and the second base plate.
Regarding claims 21 and 22, Lim as modified by Loebl in claim 18 above suggests wherein movement of the arm assemblies causes the first and second base plates to pivot with respect to the first block (see paragraph [0047] of Lim, movement of arm assemblies cause first and second base plates to move outwardly with respect to the first block; see Figs. 4A-4C of Loebl, expansion of an arm assembly causes first and second base plates to pivot and be angled during outward movement of the plates).
Regarding claim 24, Lim discloses further comprising a second block (elongated body 32, see paragraph [0031] and Figs. 1-3) disposed between the first base plate and the second base plate.
Regarding claim 25, Loebl suggests wherein the first member (20) and the second member (12) each have an opening defined therein configured to allow bone growth into an open space defined by the device (see paragraph [0067] and Figs. 1A-3B). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide the first and second plate members with openings in order to facilitate permanent positioning of the device between adjacent vertebrae via spinal fusion.
Regarding claims 26 and 27, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to make the maximum separation of the outer bearing surface define an angle of greater than 20 degrees and an angle of 23 degrees because Loebl discloses that establishing an optimal lordotic angle is a result effective variable (see paragraph [0062]), and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 28, Lim is silent regarding the outer bearing surfaces comprising textured surfaces. However, Loebl discloses a spinal device (10) wherein outer bearing surfaces (12/22) of first and second base plates (12/20) are textured (see paragraph [0065]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the outer bearing surfaces to comprise textured surfaces in order to anchoring of the device against adjacent tissue surfaces (see Loebl, paragraph [0065]).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Loebl, and further in view of U.S. Patent Application Publication No. 2013/0197642 (Ernst).
Regarding claim 23, Lim discloses further comprising an actuation member (30), but fails to disclose the actuation member configured to be rotated to cause movement of the arm assemblies, wherein the actuation member is configured to be threadedly coupled to internal threading of the first block. However, Lim does disclose that other actuation members may be used (see paragraphs [0008], [0035], [0036], [0040], and [0041]). Additionally, Ernst discloses an expandable implant (10A) having upper and lower base plates (20A/20B), wherein an actuation member (40) is configured to rotate to cause movement of arm assemblies (50) , wherein the actuation member is configured to be threadedly coupled to internal thread (42A) of a first block (30A) (see paragraphs [0029] and [0030]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to substitute the actuation member of Ernst for the actuation member of Lim as such a modification merely involves substituting one known actuation member from a known spinal implant for another known actuation member from another known spinal implant without any unpredictable results.
Claims 29, 30, 33, 35-37, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Loebl and U.S. Patent Application Publication No. 2011/0160861 (Jimenez).
Regarding claim 29, Lim discloses a method, comprising: providing an expandable interbody fusion device (10), comprising; a first base plate (upper plate 50, see Figs. 1 and 2) having a first outer bearing surface (52); a second base plate (lower plate 50, see Figs. 1 and 2) having a second outer bearing surface (52); and only two arm assemblies (each arm assembly comprises a pair of linkages 40, and “[i]n another embodiment (not illustrated), spacer 10 includes only two pairs of linkages 40, or four total linkages”, see paragraph [0025]), wherein a first of the two arm assemblies is arranged on a first side of the device and a second of the two arm assemblies is arranged on a second side of the device (see paragraph [0025], “[i]n another embodiment (not illustrated), spacer 10 includes only two pairs of linkages 40, or four total linkages”; in a device with only two arm assemblies, it would be obvious for the two arm assemblies to be arranged on opposite first and second sides of the device to allow for even distribution of load and symmetrical movement of the plates relative to each other), wherein each of the only two arm assemblies comprises only a first rigid member (one of linkages 40 in a pair; see paragraph [0025]) and a second rigid member (another of linkages 40 in a pair; see paragraph [0025]) that pivot with respect to one or more of the first base plate and the second base plate (see paragraph [0032] and Figs. 1 and 2; pivoting about a pin 61 or 62, e.g.); and performing an intervertebral body fusion and distraction procedure with the expandable interbody fusion device (see Abstract), comprising: inserting the expandable interbody fusion device into an intervertebral disc space of a patient defined between adjacent vertebrae such that the first bearing surface interfaces with an end plate of a superior vertebra of the intervertebral disc space and the second bearing surface interfaces with an end plate of an inferior vertebra of the intervertebral disc space (see Abstract and paragraphs [0024], [0028], and [0038]); causing the arm assemblies to move such that the first outer bearing surface and the second outer bearing surface separate relative to one another (see paragraph [0038]); and leaving the device within the intervertebral disc space (see paragraph [0037] and Abstract).
Further regarding claim 29, Lim is silent on the device 10 having movement of the arm assemblies causing the first outer bearing surface and the second outer bearing surface be angled relative to one another. However, Loebl discloses an intervertebral spinal device (10) wherein an expansion of an arm assembly (26) causes first and second base plates (12/20) and their respective bearing surfaces to be angled relative to one another (see Figs. 4A-4C). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Lim to have angled bearing surfaces upon expansion of the arm assemblies as suggested by Loebl in order to facilitate restoration of a desirable degree of lordosis (see paragraph [0062], e.g.).
Regarding claim 30, Lim discloses wherein causing the arm assemblies to move includes actuating an actuation member (30) of the expandable interbody fusion device (see paragraphs [0037]-[0040]).
Regarding claim 33, Lim discloses wherein inserting the expandable interbody fusion device into the intervertebral disc space includes inserting the expandable interbody fusion device with the first base plate and the second base plate parallel with one another (see paragraph [0033]).
Regarding claims 35 and 36, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to make the maximum separation of the outer bearing surface define an angle of greater than 20 degrees and an angle of 23 degrees because Loebl discloses that establishing an optimal lordotic angle is a result effective variable (see paragraph [0062]), and it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 37, Lim discloses wherein inserting the expandable interbody fusion device into an intervertebral disc space include inserting the expandable interbody fusion device into an intervertebral disc space of a lumbar spine (see paragraph [0066]).
Regarding claim 39, Lim is silent regarding wherein the procedure further comprise removing a lumbar disc from the intervertebral disc space. However, Jimenez discloses that a procedure for inserting an intervertebral implant in a disc space can comprise removing a lumbar disc from the intervertebral disc space (see paragraphs [0003]-[0005]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Lim to remove a lumbar disc from the disc space in order to allow implantation and access to the inner disc space for implantation of the device (see Jimenez, paragraphs [0003]-[0005]).
Further regarding claims 29, 30, 33, 35-37, and 39, Lim is silent on providing instructions for performing the intervertebral body fusion and distraction procedure. However, Jimenez discloses that a method can comprise providing an expandable interbody fusion device and providing instructions for implanting the device (see claim 19). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Lim to provide instructions for performing the intervertebral body fusion and distraction procedure in order to guide a user in how to properly implant the device in a patient.
Claims 31, 32, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Loebl and Jimenez, and further in view of Ernst.
Regarding claims 31 and 32, Lim discloses further comprising an actuation member (30), but fails to disclose the actuation member comprising a screw and actuating the actuation member includes rotating the screw. However, Lim does disclose that other actuation members may be used (see paragraphs [0008], [0035], [0036], [0040], and [0041]). Additionally, Ernst discloses an expandable implant (10A) having upper and lower base plates (20A/20B), wherein an actuation member screw (40) rotates to cause movement of arm assemblies (50) , wherein the screw is threadedly (42A) coupled with a first block (30A) disposed between the base plates (see paragraphs [0029] and [0030]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method by substituting the actuation member of Ernst for the actuation member of Lim as such a modification merely involves substituting one known actuation member from a known spinal implant for another known actuation member from another known spinal implant without any unpredictable results.
Regarding claim 34, Lim is silent regarding wherein the procedure further comprises inserting a bone growth material into an open area within the device. However, Ernst discloses an expandable intervertebral device (10A) wherein a method of implanting the device includes inserting a bone growth material into an open area within the device (see paragraph [0044]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Lim to insert a bone growth material into an open area within the device in order to facilitate fusion of the device with adjacent bone (see Ernst, paragraph [0044]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Lim in view of Loebl and Jimenez, and further in view of U.S. Patent Application Publication No. 2007/0282449 (de Villers).
Regarding claim 38, Lim is silent regarding wherein inserting the expandable interbody fusion device into an intervertebral disc space of the lumbar spine includes inserting the expandable interbody fusion device through a minimally invasive port that goes through a muscle of the lumbar spine. However, Lim does suggest using a minimally invasive technique for inserting the device (see Abstract), and de Villers discloses a method of inserting an intervertebral device into an intervertebral disc space includes inserting the device through a minimally invasive portion that goes through a muscle of the lumbar spine (see de Villers, paragraphs [0004] and [0140]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Lim to insert the device through a minimally invasive portion that goes through a muscle of the lumbar spine, as de Villers suggests such an approach is appropriate for a minimally invasive insertion of an implant into the lumbar spine (see de Villers, paragraphs [0004] and [0140]).
Response to Arguments
Applicant's arguments filed August 3, 2026 have been fully considered but they are not persuasive.
Applicant argues on pages 6-8 of the Remarks that the combination of Lim and Leobl fails to suggest side-mounted arm assemblies that cause the bearing surfaces of the device to become angled relative to one another. Applicant argues on page 7 of the Remarks that Loebl suggests using a linking segment positioned at an end of the device to cause separation and angling of bearing surfaces relative to each other; thus, incorporating an end-mounted linking segment at an end of the device of Lim would fail to yield the claimed invention, which requires side-mounted arm assemblies to cause angling of the bearing surfaces. Applicant argues on pages 7-8 of the Remarks that Leobl can only be relied on for suggesting the general desirability of angled bearing surfaces, and absent a teaching from Leobl on how two side-mounted arm assemblies would achieve angled bearing surfaces, the combination fails to suggest the claimed invention. The examiner disagrees.
The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). The examiner’s rejection is not based on removing the side-arm assemblies of the device of Lim or adding the end-mounted linkage member of Leobl to the device of Lim. Rather, the rejection is based on modifying the device to have angled bearing surfaces upon expansion of the side-mounted arm assemblies as suggested by Loebl in order to facilitate restoration of a desirable degree of lordosis (see paragraph [0062], e.g.).
In response to Applicant’s argument that Loebl does not teach a specific mechanism for using side-mounted arm assemblies to achieve angled bearing surfaces, “[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton.” See KSR, 550 U.S. at 421, 82 USPQ2d at 1397. It would be obvious to one of ordinary skill in the art that mounting the side arm assemblies towards one end of the device would lead to uneven expansion of the device at one end versus the other, thus resulting in angled bearing surfaces. This would be true even while keeping the arms side-mounted instead of end-mounted, so long as the expansion of the device is biased toward one end of the device. While Loebl uses a different separation and expansion mechanism, Loebl demonstrates that uneven expansion of the device results in angled bearing surfaces.
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 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 NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert, can be reached on 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
Prosecution Insights