DETAILED ACTION
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 1-7 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2017/0112630 (Kuyler) in view of U.S. Patent Application Publication No. 2008/0140207 (Olmos).
Regarding claim 1, Kuyler discloses an expandable interbody (212) comprising: a superior shell (214); an inferior shell (216); and a control assembly (246/244) situated between the superior and inferior shells, the control assembly comprising proximal (244) and distal (320) cages and an adjustment screw (321) defining an axis (X8), the adjustment screw configured to engage the proximal and distal cages (see Figs. 13 and 15 and paragraphs [0091] and [0092]) and to adjust their position relative to each other along the axis when the adjustment screw is rotated (see Figs. 12-15 and paragraphs [0092]-[0094]); wherein the proximal ends of the superior and inferior shells are configured to pivotally engage respective portions of the proximal cage (via hinge points, see marked-up Figs. 10 and 11 below); wherein translation of the distal cage along the axis (see paragraphs [0092] and [0093] and Figs. 12-15) causes the respective distal ends of the superior and inferior shells to move apart from an unexpanded state to an expanded state (see paragraphs [0092] and [0093] and Figs. 12-15).
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Further regarding claim 1, Kuyler fails to disclose the proximal and distal cages interlocked such that the proximal and distal cages are configured to slidingly engage each other and provide stability to each other as they are adjusted by the adjustment screw. However, Olmos discloses an expandable interbody (10) comprising: a superior shell (14); an inferior shell (16); and a control assembly (30) situated between the superior and inferior shells, the control assembly comprising interlocking proximal (34) and distal (32) cages (see Figs. 1-8) and an adjustment screw (50) defining an axis (along the length of screw 50), the proximal and distal cages are configured to slidingly engage each other and provide stability to each other as they are adjusted by the adjustment screw (see Figs. 1-8 and paragraphs [0082] and [0083]).
Regarding claim 2, Olmos suggests wherein the proximal and distal cages each comprise a plurality of respective planar surfaces (63/64), wherein at least some of the planar surfaces of the proximal cage or configured to slidingly engage at least some of the planar surfaces of the distal cage (see paragraph [0099]).
Regarding claim 3, Olmos suggests wherein the proximal cage comprises a pair of lateral walls (63), and the distal cage comprises a pair of lateral walls (64);and wherein at least a portion of the proximal cage lateral walls is configured to slidingly engage or support at least a portion of the distal cage lateral walls (see paragraph [0099]). Alternatively, Figs. 3-8 show that the cages 32/34 slidingly engage each other along their respective side walls.
Regarding claim 4, Olmos suggests wherein the proximal and distal cages provide stability to each other irrespective of whether the interbody is in the unexpanded state or the expanded state (in the unexpanded and expanded states, cages 32/34 are stably mated to each other and can provide rotational stability relative to each other; see paragraphs [0082], [0083], and [0099]).
Regarding claim 5, Olmos suggests wherein the proximal and distal cages are configured to slidingly engage at least a portion of respective side walls of the superior and inferior shells so as to provide stability to the shells irrespective of whether they are in the unexpanded state or the expanded state (see paragraphs [0105] and [0111], sides of cages slidingly engage portions 18/20 and 70/72 of shells; see also Figs. 1-4, lateral side walls of each shell 14/16 keep the cages laterally contained inside the superior and inferior shells in the expanded and unexpanded states).
Regarding claim 6, Olmos suggests wherein the proximal and distal cages each comprise at least a pair of side walls (sides of each cage 32/34); wherein each side wall of the proximal cage is coplanar with a respective side wall of the distal cage (see Figs. 3-9F; at least parallel sides of cages 32/34 are coplanar with each other).
Regarding claim 7, Olmos suggests wherein the respective pairs of side walls are configured to slidingly engage interior planar surfaces of the superior and inferior shells, respectively (see paragraphs [0105] and [0111], sides of cages slidingly engage interior planar surfaces 18/20 and 70/72 of shells; see also Figs. 1-4, interior planar side walls of each shell 14/16 slidingly engage lateral sides of each cage).
Further regarding claim 1-7, 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 have the proximal and distal cages of Kuyler slidingly engaged and interlocked to each other as suggested by Olmos in order to allow for movement of the cages relative to each other, and thus expansion of the interbody, to be controlled and set as desired by the user (see paragraphs [0082] and [0083] and of Olmos).
Regarding claim 12, Kuyler discloses wherein the distal cage further comprises distal ramped surfaces (rounded ends of arms 250/252 and 300 in contact with curved surfaces of members 214 and 216, respectively) configured to slidingly engage respective ramp surfaces on the superior and inferior shells (see Figs. 7, 9, 12, 13, 15, and 16-18).
Regarding claim 13, Kuyler discloses wherein the distal cage further comprises a superior rounded surface (rounded ends of arms 250/252 in contact with member 214) and an inferior rounded surface (rounded ends of linkage 300 in contact with member 216) each configured to slidingly engage respective interior surfaces of the superior and inferior shells (see Figs. 7, 9, 12, 13, 15, and 16-18).
Regarding claims 14 and 15, Kuyler discloses wherein the pivotal engagement between the proximal cage and the superior and inferior shells, respectively, is achieved with a pair of superior extensions on the proximal cage configured to engage a portion of the superior shell and a pair of inferior extensions on the proximal cage configured to engage a portion of the inferior shell (see marked-up Fig. 16 below); wherein each of the respective portions of the superior and inferior shells comprises a pair of curved projections that extend proximally from the superior and inferior shells (see marked-up Fig. 16 below).
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Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kuyler in view of Olmos, and further in view of U.S. Patent Application Publication No. 2016/0120660 (Melkent).
Regarding claim 8, Kuyler discloses wherein respective distal ends of the superior and inferior shells, in the unexpanded state, partially enclose a distal end of the distal cage (see Figs 7, 9, and 17; distal ends of each shell are curved partially enclose the distal end of the distal cage; see also Figs. 1, 2, and 5 regarding similar interbody 12). Kuyler fails to disclose the shells fully enclosing a distal end of the distal cage. However, Melkent discloses an expandable interbody implant (20) wherein superior and inferior shells (26/32) fully enclose a distal end of a distal cage (80) when in an unexpanded state (see Figs. 1 and 3). 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 shells of Kuyler to fully enclose a distal end of the distal cage when in an unexpanded state as suggested by Melkent in order to provide more structural integrity to the implant in the unexpanded state by having the shells engaged with each other over the length of the implant.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kuyler in view of Olmos, and further in view of U.S. Patent Application Publication No. 2016/0166396 (McClintock).
Regarding claim 11, Kuyler appears to disclose wherein the distal cage further comprises a retention pin (see marked-up Fig. 9) configured to hold the adjustment screw in place relative to the distal cage (see paragraph [0092]).
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Alternatively, McClintock discloses an expandable interbody (100) comprising an adjustment screw (172) and a distal cage (176), wherein the distal cage comprises a retention pin (171) configured to hold the adjustment screw in place relative to the distal cage (see paragraph [0071]). 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 distal cage of Kuyler to have a retention pin configured to hold the adjustment screw is place relative to the distal cage in order to facilitate expansion of the interbody by using longitudinal movement of the screw to cause longitudinal movement of the distal cage (see Kuyler, paragraph [0092] and McClintock, paragraph [0077]).
Allowable Subject Matter
Claims 9 and 10 are 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.
Claims 16-20 are allowed.
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 (1) there is no reason to combine the teachings of Kuyler and Olmos as outlined in the rejections above; and (2) the combined teachings of Kuyler and Olmos would not have achieved a predictable result.
Reason to modify Kuyler and Olmos
Applicant argues on page 7 of the Remarks that Olmos does not provide expansion in a controlled manner in a way different or advantageous over Kuyler’s expansion mechanism. The examiner disagrees. Paragraphs [0082] and [0083] of Olmos disclose that overlapping cages 32/34 can be controlled and set as desired by the user via engaged structures 40/44 on the cages that allow for incremental adjustment of expansion of the interbody, and resistance to movement once the device is set to protect against unintentional collapsing of the device. Kuyler fails to disclose such features.
Modifying Kuyler with Olmos achieves a predictable result
Applicant argues on pages 7-8 of the Remarks that it is not apparent how the sliding inner and outer sleeves of Olmos could be incorporated in Kuyler’s screw-based design. 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 modification does not seek to modify how the cages are moved relative to each other. Modifying the cages of Kuyler to be overlapping and selectively controlled relative to each other (via structures 40/44, e.g.) as suggested by Olmos can be done regardless of how relative movement of the cages is achieved.
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.
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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.
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
