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 amended claim set was received on 07/24/2026. This claim set is accepted and overcomes the USC 112 rejections set forth prior.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over McAtamney et al. (US 20150305887 A1) (hereon referred to as McAtamney) in view of Mclver et al. (US 11413151 B1) (hereon referred to as Mclver).
McAtamney teaches a bone anchor (510) for securing an intervertebral implant (see Fig. 1) comprising:
a spherical head (530, see Para. [0079]) and a curved blade (520) extending therefrom, the spherical head defining a non-threaded opening (540 and 550) including a vertical slot (540) in communication with an internal spherical pocket (550) defined within the spherical head (see Para. [0077]),
the vertical slot (540) has a narrow width defined between opposing flat sides with an elongated length longer than the width (see Fig. 13), the vertical slot being aligned with a longitudinal axis of the anchor (see labelled diagram of Fig. 14 below) (claim 1),
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wherein the vertical slot (540) has an obround shape (see Para. [0077]) (claim 2),
wherein the vertical slot (540) is offset toward a top of the spherical head such that a top end of the vertical slot (540) cuts deeper into the spherical head relative to a bottom end of the vertical slot (see labelled diagram of Fig. 15 below) (claim 3),
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wherein the internal spherical pocket (550) has a diameter greater than the width of the vertical slot, thereby forming an overhang beneath the sides of the vertical slot (see labelled diagram of Fig. 15 below) (claim 4),
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wherein each side of the vertical slot (540) defines symmetric lips (note that the slot has a constant width, formed by parallel lips; see Para. [0078]) (claim 5),
wherein an apex of each lip is truncated with a flat surface (see labelled diagram of Fig. 11 below) (claim 6),
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wherein the curved blade (520) includes an elongate fin that ends away from a concave surface of the blade such that the elongate fin is generally orthogonal to the blade (see labelled diagram of Fig. 13 below) (claim 7),
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However fails to teach the spherical head including a raised bump located beneath and adjacent to the vertical slot creating a thickened wall area, the raised bump having a radius smaller than the radius of the spherical head and a width greater than the width of the vertical slot, wherein the raised bump is configured to engage a socket of an implant to limit rotation of the anchor (claim 1),
Mclver teaches a bone anchor (104) for securing an intervertebral implant (see Fig. 1) comprising:
a spherical head (110) and a curved blade (112) extending therefrom, the spherical head including a pocket (1100) defined within the spherical head (see Fig. 11),
further including a raised bump (formed in between features 1200, see labelled diagram of Fig. 12 below) located beneath and adjacent to the vertical slot creating a thickened wall area (see labelled diagram of Fig. 12 below),
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the raised bump having a radius smaller than the radius of the spherical head and a width greater than the width of the vertical slot (see labelled diagram of Fig. 12 below), wherein the raised bump is configured to engage a socket of an implant to limit rotation of the anchor (see Col. 6, ll. 59-65).
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It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spherical head of McAtamney to include the raised bump of Mclver, wherein the raised bump is located beneath and adjacent to the vertical slot creating a thickened wall area, the raised bump having a radius smaller than the radius of the spherical head and a width greater than the width of the vertical slot, wherein the raised bump is configured to engage a socket of an implant to limit rotation of the anchor (claim 1), as this would prevent unwanted rotation of the head within its corresponding socket (see Col. 6, ll. 59-65).
Claims 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Seifert et al. (US 20160242927 A1) (hereon referred to as Seifert) in view of McAtamney and further in view of Mclver.
Seifert teaches a spine stabilization system (see Figs. 57-61C) comprising:
an expandable implant having an upper endplate (502), a lower endplate (504), and an actuator assembly (456, 452) including a moveable anterior actuator (470), a moveable posterior actuator (489), and a stationary posterior actuator (452) positioned between the upper (502) and lower (504) endplates to independently control anterior and posterior heights of the implant (see Para. [0164]; note that embodiments may be combined, see Para. [0163]);
a bone anchor (506) insertable through the upper (502) or lower (504) endplate and into adjacent bone, the bone anchor (506) having a spherical head (516) and a curved blade (see Fig. 61A) extending therefrom (see Para. [0167]) (claim 8), wherein the upper and/or lower endplates define a socket (421) configured to receive the spherical head of the bone anchor (506), which guides the anchor into the adjacent bone (see Para. [0154]) (claim 9), wherein the socket (421) has a partial spherical cut (see Fig. 54A), which provides a congruent surface for the spherical head (516) of the anchor (506, see Para. [0167]) to permit rotation of the anchor within the socket (see Para. [0154]) (claim 10), wherein the socket (421) defines a stop (420 and 419), which engages with a raised bump to limit rotation of the anchor (note that the stop portions 420 and 419 are configured to engage with any bump or protrusion that makes contact thereto) (claim 11), wherein the stop allows for up to 20 degrees of rotation for the anchor within the socket (see Para. [0104]) (claim 12), wherein the expandable implant includes a blocking screw (419), which when rotated, covers a portion of the spherical head of the anchor (see Para. [0154]), thereby preventing the anchor from backing out after insertion, wherein a raised bump may prevent the non-threaded opening of the anchor from aligning with the blocking screw (note that a raised bump is capable of enabling said lack of alignment) (claim 13), a method of implanting an orthopedic implant (500) comprising:
inserting an orthopedic implant between adjacent vertebrae (see Para. [0165]), the orthopedic implant (500) comprising a first endplate (502) defining a first socket (see labelled diagram of Fig. 57 below), a second endplate (504) defining a second socket (see labelled diagram of Fig. 57 below), and an actuator assembly (456, 452) including a moveable anterior actuator (470), a moveable posterior actuator (489), and a stationary posterior actuator (452) positioned between the upper (502) and lower (504) endplates to independently control anterior and posterior heights of the implant (see Para. [0164]; note that embodiments may be combined, see Para. [0163]);
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expanding the implant to adjust height and/or lordosis (see Para. [0165]); inserting the first anchor into the first socket of the first endplate to engage an upper vertebra (see Para. [0163]) (claim 14),
however fails to teach the spherical head defining a non-threaded opening including a vertical slot in communication with an internal spherical pocket defined within the spherical head, the vertical slot has a narrow width defined between opposing flat sides with an elongated length longer than the width, the vertical slot being aligned with a longitudinal axis of the anchor,
the spherical head includes a raised bump located beneath and adjacent to the vertical slot creating a thickened wall area,
the raised bump having a radius smaller than the radius of the spherical head and a width greater than the width of the slot, wherein the raised bump is configured to engage a socket of an implant to limit rotation of the anchor (claim 8),
attaching a first anchor to a single anchor impactor instrument having a non-threaded distal tip configured to mate with a non-threaded opening in the anchor, the instrument includes an inner shaft positioned through an outer sleeve, the inner shaft includes an elongated tip having curved sides with at least one flat side configured to mate with a corresponding flat side within a vertical slot of the anchor, the outer sleeve includes a distal end with a protruding rim, wherein the first anchor is attached to the instrument by rotating the inner shaft, which rotates the anchor such that the protruding rim of the outer sleeve fits under an overhang along sides of the vertical slot, thereby securing the first anchor to the instrument;
pivoting the first anchor along an axis of the vertical slot to accommodate a straight or angled trajectory for the first anchor,
wherein the anchor comprises a raised bump adjacent to the vertical slot that is configured to engage one of the first socket or the second socket of the orthopedic implant to limit rotation of the anchor (claim 14),
wherein the inner shaft includes a ball detent configured to engage with divots within a housing of the outer sleeve such that the inner shaft is held in one of two relative positions defined by the divots when the inner shaft is rotated with respect to the outer sleeve (claim 15), wherein the inner shaft rotates 90 degrees relative to the stationary outer sleeve (claim 16), further comprising a length of the vertical slot permits the anchor to pivot based on limits imposed by ends of the vertical slot (claim 17), further comprising attaching a second anchor to the single anchor impactor instrument by rotating the inner shaft and the anchor such that the protruding rim of the outer sleeve fits under the overhang along the sides of the vertical slot, thereby securing the second anchor to the instrument (claim 18), further comprising inserting the second anchor into the second socket of the second endplate to engage a lower vertebra (claim 19).
McAtamney teaches a bone anchor (510) for securing an intervertebral implant (see Fig. 1) comprising: a spherical head (530, see Para. [0079]) and a curved blade (520) extending therefrom, the spherical head defining a non-threaded opening (540 and 550) including a vertical slot (540) in communication with an internal spherical pocket (550) defined within the spherical head (see Para. [0077]), the vertical slot (540) has a narrow width defined between opposing flat sides with an elongated length longer than the width (see Fig. 13), the vertical slot being aligned with a longitudinal axis of the anchor (see labelled diagram of Fig. 14 above).
McAtamney further teaches attaching a first anchor to a single anchor impactor instrument (500) having a non-threaded distal tip configured to mate with a non-threaded opening in the anchor (see Fig. 12), the instrument includes an inner shaft (570) positioned through an outer sleeve (560), the inner shaft (570) includes an elongated tip (580) having curved sides with at least one flat side configured to mate with a corresponding flat side within a vertical slot of the anchor (see Fig. 12), the outer sleeve includes a distal end with a protruding rim (see Fig. 15), wherein the first anchor (510) is attached to the instrument by rotating the inner shaft (see Para. [0078]), which rotates the anchor such that the protruding rim of the outer sleeve fits under an overhang along sides of the vertical slot (see Fig. 15), thereby securing the first anchor to the instrument (see Para. [0079]); pivoting the first anchor along an axis of the vertical slot to accommodate a straight or angled trajectory for the first anchor (see Para. [0079]), wherein the inner shaft (570) includes a ball detent (see Fig. 11) configured to engage with divots (600) within a housing of the outer sleeve such that the inner shaft is held in one of two relative positions defined by the divots when the inner shaft is rotated with respect to the outer sleeve (see Para. [0080]), wherein the inner shaft (570) rotates 90 degrees relative to the stationary outer sleeve (see Figs. 12-13), further comprising a length of the vertical slot (540) permits the anchor to pivot based on limits imposed by ends of the vertical slot (see Para. [0078]), further comprising attaching a second anchor to the single anchor impactor instrument (see Para. [0011]) by rotating the inner shaft and the anchor such that the protruding rim of the outer sleeve fits under the overhang along the sides of the vertical slot (see Para. [0078]), thereby securing the second anchor to the instrument (see Paras. [0011] and [0081]), further comprising inserting the second anchor into the second socket of the second endplate to engage a lower vertebra (see Paras. [0011] and [0078]).
Mclver teaches a bone anchor (104) for securing an intervertebral implant (see Fig. 1) comprising:
a spherical head (110) and a curved blade (112) extending therefrom, the spherical head including a pocket (1100) defined within the spherical head (see Fig. 11),
further including a raised bump (formed in between features 1200, see labelled diagram of Fig. 12 above) located beneath and adjacent to the vertical slot creating a thickened wall area (see labelled diagram of Fig. 12 above),
the raised bump having a radius smaller than the radius of the spherical head and a width greater than the width of the vertical slot (see labelled diagram of Fig. 12 above), wherein the raised bump is configured to engage a socket of an implant to limit rotation of the anchor (see Col. 6, ll. 59-65).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spine stabilization system of Seifert to have the spherical head configuration (claim 8) of McAtamney, as this would enable polyaxial rotation of the spherical head prior to implantation (see Para. [0082]), and further to modify the method of Seifert such that there is an anchor impacting instrument (claim 14) as taught by McAtamney, further comprising a ball detent and corresponding divots (claim 15), wherein the inner shaft rotates 90 degrees relative to the outer sleeve (claim 16), comprising a length of the vertical slot permits the anchor to pivot based on limits imposed by ends of the vertical slot (claim 17), attaching a second anchor to the single anchor impactor instrument by rotating the inner shaft and the anchor such that the protruding rim of the outer sleeve fits under the overhang along the sides of the vertical slot (claim 18), and inserting the second anchor into the second socket of the second endplate to engage a lower vertebra (claim 19) as taught by McAtamney, as such instrument medications would improve implantation methods for a correlating non-threaded anchor instrument (see Para. [0023]); it would furthermore be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the spherical head of Seifert in view of McAtamney to have a raised bump located beneath and adjacent to the vertical slot creating a thickened wall area, the raised bump having a radius smaller than the radius of the spherical head and a width greater than the width of the slot, wherein the raised bump is configured to engage a socket of an implant to limit rotation of the anchor, as this would prevent unwanted rotation of the anchor (see Col. 6, ll. 59-65).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Seifert in view of McAtamney and Mclver as applied to claim 14 above, and further in view of Glaser et al. (US 20240180592 A1) (hereon referred to as Glaser).
Seifer teaches a method of implanting an orthopedic implant as outlined in the rejection of claim 14 above, McAtamney teaches a bone anchor with a spherical head and a corresponding anchor impactor instrument as outlined in the rejection of claim 14 above, and Mclver teaches a raised bump configuration as outlined in the rejection of claim 14 above, however the combination of the three fails to teach the step of disassembling the inner shaft from the outer sleeve by depressing a release button within the outer sleeve to disengage from the inner shaft.
Glaser teaches a tool (12) for implantation of a bone fixation device (see Para. [0112]), wherein the tool has an inner shaft (14) and an outer sleeve (58), further comprising a button (84) configured to be pressed to enable disengagement of the inner shaft (see Para. [0119]).
It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the anchor impactor of McAtamney to disassemble the inner shaft from the outer sleeve by depressing a release button within the outer sleeve to disengage from the inner shaft, as such a release mechanism would be necessary in order to allow for the release of the bone fastener and corresponding tool (see Para. [0115]).
Response to Arguments
Applicant’s arguments with respect to claims 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 HOLLY J LANE whose telephone number is (703)756-4702. The examiner can normally be reached Monday-Friday 9:00am-5:00pm.
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/H.J.L./Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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