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 .
Drawings
The drawings were received on 01/27/2026. These drawings are acceptable.
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, 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Freedman et al. (US Publication NO. 2019/0231551 A1).
Regarding Claim 1, Freedman discloses an expandable implant (1010, Fig. 22) movable between a contracted position and an expanded position [0190], comprising:
a body extending from a proximal end to a distal end in a proximal-to-distal direction and extending from a first lateral side to a second lateral side in a widthwise direction (Note the proximal direction can be considered towards the far side as shown in Fig. 22 since this is merely an orientation description. A user can be on the far side shown in Fig. 22 below making that proximal to said user, or the far side in Fig 22 can be closer to the center of the patient, thereby also making this a ‘proximal’ side.)
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the body being defined by a superior endplate and an inferior endplate that are pivotally connected (see figure below); wherein the superior endplate includes an inside surface that comprises an inclined ramp (shown below); wherein the inferior endplate comprises a support frame, an inside superior-facing surface including a channel (1132),
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wherein the support frame includes a frame portion having a proximal surface and a distal surface, wherein an aperture extends through the proximal surface and the distal surface (see below);
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a wedge (1080) disposed between the superior endplate and the inferior endplate [0183], the wedge including: a bearing surface (1035) on an upper end thereof configured to slide across the inclined ramp and a tang (1131) positioned opposite the bearing surface on a lower end thereof configured for disposal within the channel (Fig. 24) [0183]; and
an expansion screw (1084) extending through the aperture and being operatively coupled to a threaded portion of the wedge [0183, 0190], wherein the expansion screw is configured to rotate and thereby linearly translate the wedge in a longitudinal direction [0190]; wherein proximal movement (note that proximal direction is to the hinged end as shown in the figure above) of the wedge causes the superior endplate to rotate away from the inferior endplate [0190].
Regarding Claim 12, Freedman discloses the superior endplate comprises a first bone screw aperture (1040) configured to orient a first bone screw in a cephalad direction; and the inferior endplate comprises a second bone screw aperture (1061) configured to orient a second bone screw in a caudal direction (fig. 24) [0188]. The contour shown in the figure below can be considered bone screw relief cutouts because they act to provide additional clearance to the opposing bone screws during an installation process.
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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) 1, 3-4, 7, 10-11, 13-14 and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McLuen et al. (US Publication No. 2021/0068973 A1) in view of Ibarra et al. (US Patent No. 9603717 B2).
Regarding Claim 1, McLuen discloses an expandable implant (100’, Fig. 2C, [0066]) movable between a contracted position (shown in Fig. 2C) and an expanded position (described in figure below) [0066], comprising:
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a body (102+104) extending from a proximal end to a distal end in a proximal-to-distal direction (shown above) and extending from a first lateral side to a second lateral side in a widthwise direction (see figure below),
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the body being defined by a superior endplate (104) and an inferior endplate (102) that are pivotally connected (pivot connection 106, Fig. 2c) [0066];
wherein the superior endplate (104) includes an inside surface that comprises an inclined ramp (114) [0062] (see figure below);
wherein the inferior endplate (102) comprises a support frame (proximal part shown below where screw 108 extends through), an inside superior-facing surface (shown below), wherein the support frame includes a frame portion having a proximal surface and a distal surface (shown below), wherein an aperture extends through the proximal surface and the distal surface (aperture accommodates screw 108, see Fig. 1A as an example);
a wedge (112) disposed between the superior endplate (102) and the inferior endplate (104) (Fig. 2C), the wedge including: a bearing surface on an upper end thereof (shown below) configured to slide across the inclined ramp [0062] and a surface opposite the bearing surface on a lower end thereof (shown below); and
an expansion screw (108) extending through the aperture (see for example Fig. 3A) and being operatively coupled to a threaded portion of the wedge (112) [0066], wherein the expansion screw is configured to rotate and thereby linearly translate the wedge in a longitudinal direction[0066]; wherein proximal movement of the wedge causes the superior endplate to rotate away from the inferior endplate (see figure above).
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The wedge slides along the superior facing surface of the inferior endplate; however, McLuen is silent to the inside superior-facing surface including a channel and the wedge having a tang positioned on the opposite surface for disposal within the channel.
Ibarra discloses an expandable implant in the same field of endeavor. Ibarra discloses a wedge which slides proximally along a superior facing surface of an inferior endplate (shown below), wherein the wedge has a tang configured to slide within a complementary shaped channel (235 in the superior facing surface) as the wedge is pulled proximally by a screw (Fig. 15A, col. 11; ln. 29-33).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the inferior surface of the wedge and the superior surface of the inferior endplate which it slides along of McLuen to have a tang on the wedge and complementary shaped channel on the endplate surface as taught by Ibarra in order to provide a known sliding connection between wedge and endplate components which would predictably allow for relative movement of the wedge along the surface of the endplate when pulled by the screw mechanism.
Regarding Claim 3, McLuen discloses a recess formed within the support frame portion, and wherein a head portion of the expansion screw resides within the recess (see below).
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Regarding Claim 4, McLuen discloses a retaining clip (110) seated within the recess (see Fig. 1E), the retaining clip being coupled to a groove portion of the expansion screw (shown below); wherein the retaining clip is configured to prevent the expansion screw from linearly translating while permitting the expansion screw to rotate; andwherein the retaining clip is configured to provide friction on the expansion screw to prevent the expansion screw from inadvertently rotating after insertion and expansion of the expandable implant [0060, 0067].
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Regarding Claim 7, McLuen discloses the frame portion further comprises a first gripping groove (116) and a second gripping groove (116) (see Fig. 1A) [0059], wherein: the first gripping groove comprises a notch on one lateral side of the frame portion; and the second gripping groove comprises a notch on an opposite lateral side of the frame portion (shown in Fig. 1A below).
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Regarding Claim 10, as modified by Ibarra, the channel extends in the proximal-to-distal direction and has a size and shape generally corresponding to a size and shape of the tang to couple the wedge within the channel (taught by Ibarra to have complementary tang/channel in proximal/distal direction (along length of screw)).
Regarding Claim 21, as modified by Ibarra, the channel is positioned behind the support frame (the area where the wedge slides) and extends along a medial portion of the inside lower surface in a proximal-to- distal direction such that the tang linearly slides within the channel thereby linearly translating the wedge in the longitudinal direction (Ibarra teaches the wedge/groove is in the middle of the wedge and in the middle of the endplate surface in the longitudinal direction).
Regarding Claim 11, McLuen discloses the expansion screw comprises a threaded portion at a distal end, a drive feature portion at proximal end, and a groove portion connecting the threaded portion and the drive feature portion, and a retaining clip is coupled to the groove portion (see figure below).
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Regarding Claim 13, McLuen discloses a system including the expandable implant (100’) as recited in the rejection of claim 1 above and a tool (400, Fig. 4A-D).
McLuen discloses a surgical tool (400) (Fig. 4A-D) for moving the expandable implant from the contracted position to the expanded position; wherein rotation of a driver (412) of the surgical tool causes the wedge to move proximally (the implant 100’ shown in Fig. 2C) and causes the superior endplate to rotate away from the inferior endplate [0077].
The wedge of McLuen slides along the superior facing surface of the inferior endplate; however, McLuen is silent to the inside superior-facing surface including a channel and the wedge having a tang positioned on the opposite surface for disposal within the channel.
Ibarra discloses an expandable implant in the same field of endeavor. Ibarra discloses a wedge which slides proximally along a superior facing surface of an inferior endplate (shown below), wherein the wedge has a tang configured to slide within a complementary shaped channel (235 in the superior facing surface) as the wedge is pulled proximally by a screw (Fig. 15A, col. 11; ln. 29-33).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the inferior surface of the wedge and the superior surface of the inferior endplate which it slides along of McLuen to have a tang on the wedge and complementary shaped channel on the endplate surface as taught by Ibarra in order to provide a known sliding connection between wedge and endplate components which would predictably allow for relative movement of the wedge along the surface of the endplate when pulled by the screw mechanism.
Regarding Claim 14, McLuen also discloses that the frame portion further comprises a first gripping groove (116) and a second gripping groove (116) (see Fig. 1A) [0059], wherein: the first gripping groove comprises a notch on one lateral side of the frame portion; and the second gripping groove comprises a notch on an opposite lateral side of the frame portion (shown in Fig. 1A below).
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McLuen also discloses the surgical tool (400) comprises a mounting jaw (406) configured to engage with the first gripping groove and the second gripping groove (116, Fig. 4D); and wherein in an insertion configuration, the first gripping groove and the second gripping groove of the expandable implant are engaged by the mounting jaw of the surgical tool (shown in Fig. 4D) [0077, McLuen].
Claim(s) 1-4, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Jazaeri et al. (US Patent No. 10426634 B1) in view of Ibarra et al. (US Patent No. 9603717 B2).
Regarding Claim 1, Al-Jazaeri discloses an expandable implant (100, Fig. 1A) movable between a contracted position (shown in Fig. 3A) and an expanded position (shown in Fig. 3C), comprising:
a body (10+30) extending from a proximal end (see below) to a distal end (see below) in a proximal-to-distal direction (longitudinally) and extending from a first lateral side to a second lateral side in a widthwise direction (see figure below),
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the body being defined by a superior endplate (30) and an inferior endplate (10) that are pivotally connected (pivot connection via pins 14, 34, Fig. 3A) [col. 3; ln. 22-36];
wherein the superior endplate (30) includes an inside surface that comprises an inclined ramp (lower surface of flange 46, Fig. 2) [col. 4; ln. 7-14];
wherein the inferior endplate (10) comprises a support frame (proximal part shown below), an inside superior-facing surface (shown below), wherein the support frame includes a frame portion having a proximal surface and a distal surface (shown below), wherein an aperture extends through the proximal surface and the distal surface (aperture accommodates screw 41, see below);
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a wedge (42) disposed between the superior endplate (30) and the inferior endplate (10) (Fig. 2), the wedge (42) including: a bearing surface on an upper end thereof (“opposing sides of an upper surface of the nut 42”, col. 4; ln. 7-8) configured to slide across the inclined ramp and a surface opposite the bearing surface on a lower end thereof (shown contacting the inside superior facing surface in the figure above); and
an expansion screw (41) extending through the aperture (Fig. 2) and being operatively coupled to a threaded portion of the wedge (42) [col. 4; ln. 7-23], wherein the expansion screw is configured to rotate and thereby linearly translate the wedge in a longitudinal direction (Fig. 3A-C)[col. 4; ln. 7-23]; wherein proximal movement of the wedge causes the superior endplate to rotate away from the inferior endplate (Fig. 3A-C shows increase in superior endplate angle as wedge is moved proximally).
The wedge slides along the superior facing surface of the inferior endplate; however, Al-Jazaeri is silent to the inside superior-facing surface including a channel and the wedge having a tang positioned on the opposite surface for disposal within the channel.
Ibarra discloses an expandable implant in the same field of endeavor. Ibarra discloses a wedge which slides proximally along a superior facing surface of an inferior endplate (shown below), wherein the wedge has a tang configured to slide within a complementary shaped channel (235 in the superior facing surface) as the wedge is pulled proximally by a screw (Fig. 15A, col. 11; ln. 29-33).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the connection between the inferior surface of the wedge and the superior surface of the inferior endplate which it slides along of Al-Jazaeri to have a tang on the wedge and complementary shaped channel on the endplate surface as taught by Ibarra in order to provide a known sliding connection between wedge and endplate components which would predictably allow for relative movement of the wedge along the surface of the endplate when pulled by the screw mechanism.
Regarding Claim 2, Al-Jazaeri discloses a groove (44) disposed on an interior sidewall of the superior endplate (Fig. 2)[col. 4; ln. 1-6]; and a pin (45) extending from the wedge (42) and being configured to slide within the groove upon linear movement of the wedge (fig. 2) [col. 4; ln. 18-23], wherein the pin (45) and the wedge (42) are fully capable of preventing an overexpansion of the implant and to maintain an angular position of the superior endplate relative to the inferior endplate.
Regarding Claim 3, Al-Jazaeri discloses a recess formed within the support frame portion (recess shown in Fig. 2 as retaining anchoring pins 43), and wherein a head portion of the expansion screw resides within the recess (see below).
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Regarding Claim 4, Al-Jazaeri discloses a retaining clip (43) seated within the recess (see Fig. 2), the retaining clip being coupled to a groove portion of the expansion screw (shown below); wherein the retaining clip is configured to prevent the expansion screw from linearly translating while permitting the expansion screw to rotate; andwherein the retaining clip is configured to provide friction on the expansion screw to prevent the expansion screw from inadvertently rotating after insertion and expansion of the expandable implant [col. 3; ln. 1-21].
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Regarding Claim 9, Al-Jazaeri discloses the superior endplate comprises a first plurality of engagement features that are angled about 20 degrees to about 40 degrees with respect to a proximal end of the superior endplate; and the inferior endplate comprises a second plurality of engagement features that are angled about 20 degrees to about 40 degrees with respect to a proximal end of the inferior endplate (shown below).
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Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Freedman et al. (US Publication NO. 2019/0231551 A1) in view of Lauf et al. (US Publication No. 2019/0298524 A1) in further view of Robinson et al. (US Publication No.
2022/0087819 A1).
Freedman discloses the implant of claim 1 as described in the rejection above. Freedman discloses that the superior endplate has bone screw apertures (1038, 1040) and the inferior endplate has bone screw apertures (1059, 1061) extending therethrough for attaching screws into the superior and inferior vertebrae respectively [0188]. However, Freedman is silent to these bone screw apertures having the specific features of:
(claim 5) at least one retention tab having a hook portion and an anchor portion; wherein the at least one retention tab is configured to automatically deflect away from the at least one bone screw aperture during installation of a corresponding bone screw and return to a retaining position upon full seating of the bone screw within the at least one bone screw aperture; or
(claim 6) a first retention tab having a first hook portion and a first anchor portion, the first retention tab being configured to: (a) cover at least a portion of the first bone screw aperture in a neutral position, and (b) deflect away from the neutral position upon driving of a first bone screw into the first bone screw aperture when a head portion of the first bone screw contacts an inclined surface of the first hook portion; and a second retention tab having a second hook portion and a second anchor portion, the second retention tab being configured to: (a) cover at least a portion of the second bone screw aperture in a neutral position, and (b) deflect away from the neutral position upon driving of a second bone screw into the second bone screw aperture when a head portion of the second bone screw contacts an inclined surface of the second hook portion.
Lauf teaches an expandable wedge implant in the same field of endeavor which includes bone screw apertures (67, 66, 46) in both the superior and inferior endplates (Fig. 10) for the purpose of attaching bone screws 100 to further secure the implant to the bone. It would have been obvious to one having ordinary skill in the art to include bone screw apertures with countersunk holes for the heads of the bone screws as taught by Lauf to enhance securement of the implant of Freedman into the bone.
Freedman and Lauf are silent to the bone screw apertures having a first retention tab having a first hook portion and a first anchor portion, the first retention tab being configured to: (a) cover at least a portion of the first bone screw aperture in a neutral position, and (b) deflect away from the neutral position upon driving of a first bone screw into the first bone screw aperture when a head portion of the first bone screw contacts an inclined surface of the first hook portion; and a second retention tab having a second hook portion and a second anchor portion, the second retention tab being configured to: (a) cover at least a portion of the second bone screw aperture in a neutral position, and (b) deflect away from the neutral position upon driving of a second bone screw into the second bone screw aperture when a head portion of the second bone screw contacts an inclined surface of the second hook portion.
Robinson discloses a wedge implant in the analogous art of bone implants which comprises bone screw retention tabs (95) for each of the bone screw receiving apertures (73/75). Robinson discloses the retention tabs (95) prevent the screws from backing out [0077] and have a configuration of a hook portion (98) and an anchor portion (93) (fig. 13). The tabs are configured to: (a) cover at least a portion of the bone screw aperture in a neutral position, and (b) deflect away from the neutral position upon driving of a bone screw into the bone screw aperture when a head portion of the bone screw contacts an inclined surface of the first hook portion [0077-0078].
It would have been obvious to one having ordinary skill in the art before the effective filing date to include screw retention tabs such as those taught by Robinson for the screw holes of the device of Freedman in view of Lauf in order to prevent screw backout thereby enhancing security of the implant.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot in view of new grounds of rejection necessitated by amendment.
Allowable Subject Matter
Claims 15-20 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JACQUELINE T JOHANAS whose telephone number is (571)270-5085. The examiner can normally be reached Mon. - Fri. 9:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert can be reached 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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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773