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 .
Response to Arguments
Applicant's arguments filed February 17, 2026, have been fully considered but they are not persuasive. On page 8 of Remarks, in the last paragraph bridging to page 9, Applicant asserts that the McIver (US 2022/0370203 A1) is improperly applied in the rejection of independent claims 1, 11 and 21 under 35 U.S.C. 103 as unpatentable over McIver in view of Gilbride (US 2019/0000638 A1). In particular, Applicant notes that the previous Office Action (mailed November 17, 2025) identifies the claimed “curved partial-tubular shank” as McIver’s curved elongate shank 112 forming at least a partial U-shape in cross-section, and argues that that Examiner has improperly relied “on a conceptual separation of the curved elongate shank 112 from the elongate fin 114 contrary to McIver’s disclosure of the shank 112 and fin 114, always together, providing maximized strength and rigidity.
Examiner respectfully disagrees with Applicant’s characterization of the “curved partial-tubular shank” described in the Office Action. For reference, Figures 1, 7 and 8 of McIver are provided below, showing anchor 104 which includes “a head portion 110 with an elongate shank and elongate fin 114 extending from the head portion” (para. 0050).
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Claim 1 requires an anchor and interbody for interbody fusion, comprising an interbody comprising “an interbody cage comprising a plurality of anchor receptacles, each anchor receptacle configured to receive an anchor to secure the interbody to a vertebra” and the anchor comprising “a head” and “a curved partial-tubular shank connected to or integral with the head at a proximal end of the curved partial-tubular shank, extending from the head”. Remaining independent claims 11 and 21 recite a similar structure. In the rejection addressing these limitations in at least claim 1, the previously Office Action on page 3 identified McIver’s components as follows (with emphasis added by Examiner):
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The Office Action did not recite – or even suggest – that McIver’s elongate fin 114 would have to be separated from the shank 112, or omitted from anchor 104 in any manner, in order to satisfy the structural requirements of an anchor comprising a head and a curved partial-tubular shank extending therefrom. One of ordinary skill in the art would reasonably understand that McIver’s elongate shank 112 of anchor 104 defines a curved partial-tubular shank, regardless of the inclusion of the reinforcing fin 114 positioned on the concave surface of the shank 112, as shown in the Figures provided above and described in at least para. 0050, 0057-0058 of McIver. Thus, the rejections set forth in the previous Office Action are maintained, as seen below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 4-5, 10-12, 14-15, 20-22, 24-25 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over McIver (US 2022/0370203 A1) in view of Gilbride (US 2019/0000638 A1).
Regarding claim 1, McIver teaches an anchor and interbody for interbody fusion (surgical implant 100 in Fig. 1; para. 0048), comprising:
an interbody (spacer 102; Fig. 1) for insertion between vertebrae of a human spine (as described in para. 0048), comprising:
an interbody cage comprising a plurality of anchor receptacles (eyelets 106; Fig. 1; para. 0048), each anchor receptacle configured to receive an anchor to secure the interbody to a vertebra (each receptacle 106 for receiving an anchor 104; Fig. 1); and
the anchor (104; Fig. 1) comprising:
a head (110; Figs. 7-9; para. 0050) configured to engage one of the plurality of anchor receptacles (106, as shown; Fig. 1);
a curved partial-tubular shank (curved elongate shank 112, where elongate shape forms a ‘curved T-shaped cross section” as recited in para. 0059, the curved cross section of elongate shank 112, i.e. in at least a partial U-shape, defines a partial-tubular shank; Figs. 7-9; para. 0057-0061) connected to or integral with the head at a proximal end of the curved partial-tubular shank, extending from the head (shown extending from head 110; Figs. 7-9); and
a straight tapered tip portion (defined by sharpened tip end 802; Fig. 8; para. 0060) at a distal end of the curved partial-tubular shank and extending from the curved partial-tubular shank (as shown at distal tip end of shank 112; Fig. 8).
McIver does not disclose the anchor shank comprising a plurality of concentric grooves on an exterior surface of the curved partial-tubular shank.
Gilbride, in analogous art, teaches an anchor (130; Figs. 1-2; para. 0055) for an interbody fusion cage (110; Fig. 1) and teaches the anchor comprising a curved shank (264; Fig. 2; para. 0072) comprising a plurality of concentric grooves on an exterior surface of the curved shank (shank 264 comprises engagement fins 278 distributed on an exterior surface thereof, the fins defining concentric grooves therebetween; Fig. 2; para. 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s anchor to include Gilbride’s engagement fins provided on interior and exterior surfaces thereof, the fins defining a plurality of concentric grooves therebetween on McIver’s curved partial tubular shank, because Gilbride teaches that the engagement fins aid in preventing the anchors from pulling out of the bone (see Gilbride, para. 0074).
Regarding claim 2, McIver and Gilbride, in combination, teach the anchor and interbody of claim 1, and McIver teaches wherein the anchor further comprises a plurality of teeth disposed on an edge of the curved partial-tubular shank (as described in para. 0061, with reference to Fig. 9, McIver teaches that the anchor 104 may include “sharpened serrations 900 proximate the tip portion 700”, the serrations defining a plurality of teeth on the shank 112).
Regarding claim 4, McIver and Gilbride, in combination, disclose the anchor and interbody of claim 1, wherein the anchor further comprises a plurality of protrusions on an interior surface the curved partial-tubular shank (McIver’s curved shank modified to include Gilbride’s engagement fins protruding from interior and exterior surfaces thereof, as described above with respect to claim 1, comprises a plurality of protrusions, i.e. fins, on an interior surface of the modified curved partial-tubular shank 112 of McIver).
Regarding claim 5, McIver and Gilbride, in combination, disclose the anchor and interbody of claim 1, wherein the anchor further comprises a plurality of grooves in an interior surface the curved partial-tubular shank (McIver’s curved shank modified to include Gilbride’s engagement fins protruding from interior and exterior surfaces thereof, as described above with respect to claim 1, comprises a plurality grooves, i.e. between the engagement fins, on an interior surface of the modified curved partial-tubular shank 112 of McIver).
Regarding claim 10, McIver and Gilbride, in combination, teach the anchor and interbody of claim 1, and McIver discloses wherein the straight tapered tip portion comprises one or more reliefs (McIver, in para. 0060 and Fig. 8, discloses the straight tapered tip 802 as having a “double beveled profile” to effectively penetrate the vertebral body, the bevels defining a relief).
Regarding claim 11, McIver teaches an anchor and interbody kit for interbody fusion (surgical implant 100 in Fig. 1; para. 0048), comprising:
an interbody (spacer 102; Fig. 1) for insertion between vertebrae of a human spine (as described in para. 0048), comprising:
an interbody cage comprising a plurality of anchor receptacles (eyelets 106; Fig. 1; para. 0048), each anchor receptacle configured to receive an anchor to secure the interbody to a vertebra (each receptacle 106 for receiving an anchor 104; Fig. 1); and
the anchor (104; Fig. 1) comprising:
a head (110; Figs. 7-9; para. 0050) configured to engage one of the plurality of anchor receptacles (106, as shown; Fig. 1);
a curved partial-tubular shank (curved elongate shank 112, where elongate shape forms a ‘curved T-shaped cross section” as recited in para. 0059, the curved cross section of elongate shank 112, i.e. in at least a partial U-shape, defines a partial-tubular shank; Figs. 7-9; para. 0057-0061) connected to or integral with the head at a proximal end of the curved partial-tubular shank, extending from the head (shown extending from head 110; Figs. 7-9); and
a straight tapered tip portion (defined by sharpened tip end 802; Fig. 8; para. 0060) at a distal end of the curved partial-tubular shank and extending from the curved partial-tubular shank (as shown at distal tip end of shank 112; Fig. 8).
McIver does not disclose the anchor shank comprising a plurality of concentric grooves on an exterior surface of the curved partial-tubular shank.
Gilbride, in analogous art, teaches an anchor (130; Figs. 1-2; para. 0055) for an interbody fusion cage (110; Fig. 1) and teaches the anchor comprising a curved shank (264; Fig. 2; para. 0072) comprising a plurality of concentric grooves on an exterior surface of the curved shank (shank 264 comprises engagement fins 278 distributed on an exterior surface thereof, the fins defining concentric grooves therebetween; Fig. 2; para. 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s anchor to include Gilbride’s engagement fins on interior and exterior surfaces thereof, the fins defining a plurality of concentric grooves therebetween on McIver’s curved partial tubular shank, because Gilbride teaches that the engagement fins aid in preventing the anchors from pulling out of the bone (see Gilbride, para. 0074).
Regarding claim 12, McIver and Gilbride, in combination, teach the anchor and interbody kit of claim 11, and McIver teaches wherein the anchor further comprises a plurality of teeth disposed on an edge of the curved partial-tubular shank (as described in para. 0061, with reference to Fig. 9, McIver teaches that the anchor 104 may include “sharpened serrations 900 proximate the tip portion 700”, the serrations defining a plurality of teeth on the shank 112).
Regarding claim 14, McIver and Gilbride, in combination, disclose the anchor and interbody kit of claim 11, wherein the anchor further comprises a plurality of protrusions on an interior surface the curved partial-tubular shank (as described above with respect to claim 1, McIver’s curved shank modified to include Gilbride’s engagement fins protruding from interior and exterior surfaces thereof comprises a plurality of protrusions, i.e. fins, on an interior surface of the modified curved partial-tubular shank 112 of McIver).
Regarding claim 15, McIver and Gilbride, in combination, disclose the anchor and interbody kit of claim 11, wherein the anchor further comprises a plurality of grooves in an interior surface the curved partial-tubular shank (McIver’s curved shank modified to include Gilbride’s engagement fins protruding from interior and exterior surfaces thereof, as described above with respect to claim 1, comprises a plurality grooves, i.e. between the engagement fins, on an interior surface of the modified curved partial-tubular shank 112 of McIver).
Regarding claim 20, McIver and Gilbride, in combination, teach the anchor and interbody of kit claim 11, and McIver discloses wherein the straight tapered tip portion comprises one or more reliefs (McIver, in para. 0060 and Fig. 8, discloses the straight tapered tip 802 as having a “double beveled profile” to effectively penetrate the vertebral body, the bevels defining a relief).
Regarding claim 21, McIver teaches a method for using an anchor and interbody for interbody fusion, comprising:
providing a patient in need of an interbody fusion (para. 0002 and 0048 describe providing surgical implant 100 to a patient for spinal fusion);
providing an anchor and interbody for interbody fusion (providing anchor 104 and interbody spacer 102; Fig. 1), comprising:
an interbody cage (102; Fig. 1) comprising a plurality of anchor receptacles (eyelets 106; Fig. 1; para. 0048), each anchor receptacle configured to receive an anchor to secure the interbody to a vertebra (each receptacle 106 for receiving an anchor 104; Fig. 1); and
the anchor (104; Fig. 1) comprising:
a head (110; Figs. 7-9; para. 0050) configured to engage one of the plurality of anchor receptacles (106, as shown; Fig. 1);
a curved partial-tubular shank (curved elongate shank 112, where elongate shape forms a ‘curved T-shaped cross section” as recited in para. 0059, the curved cross section of elongate shank 112, i.e. in at least a partial U-shape, defines a partial-tubular shank; Figs. 7-9; para. 0057-0061) connected to or integral with the head at a proximal end of the curved partial-tubular shank, extending from the head (shown extending from head 110; Figs. 7-9); and
a straight tapered tip portion (defined by sharpened tip end 802; Fig. 8; para. 0060) at a distal end of the curved partial-tubular shank and extending from the curved partial-tubular shank (as shown at distal tip end of shank 112; Fig. 8).
inserting the interbody between two vertebrae of the patient (para. 0053 describes inserting interbody spacer 102 between adjacent vertebral bodies; Fig. 1); and
inserting the anchor into one of the plurality of anchor receptacles (shown in Figs. 1 and 33-38, described in para. 0092-0097, anchor 104 is inserted into one of anchor receptacle eyelets 106).
McIver does not disclose the anchor shank comprising a plurality of concentric grooves on an exterior surface of the curved partial-tubular shank.
Gilbride, in analogous art, teaches an anchor (130; Figs. 1-2; para. 0055) for an interbody fusion cage (110; Fig. 1) and teaches the anchor comprising a curved shank (264; Fig. 2; para. 0072) comprising a plurality of concentric grooves on an exterior surface of the curved shank (shank 264 comprises engagement fins 278 distributed on an exterior surface thereof, the fins defining concentric grooves therebetween; Fig. 2; para. 0074).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s anchor to include Gilbride’s engagement fins on an exterior surface thereof, the fins defining a plurality of concentric grooves therebetween on McIver’s curved partial tubular shank, because Gilbride teaches that the engagement fins aid in preventing the anchors from pulling out of the bone (see Gilbride, para. 0074).
Regarding claim 22, McIver and Gilbride, in combination, teach the method of claim 21, and McIver teaches wherein the anchor further comprises a plurality of teeth disposed on an edge of the curved partial-tubular shank (as described in para. 0061, with reference to Fig. 9, McIver teaches that the anchor 104 may include “sharpened serrations 900 proximate the tip portion 700”, the serrations defining a plurality of teeth on the shank 112).
Regarding claim 24, McIver and Gilbride, in combination, disclose the method of claim 21, wherein the anchor further comprises a plurality of protrusions on an interior surface the curved partial-tubular shank (as described above with respect to claim 1, McIver’s curved shank modified to include Gilbride’s engagement fins protruding from interior and exterior surfaces thereof comprises a plurality of protrusions, i.e. fins, on an interior surface of the modified curved partial-tubular shank 112 of McIver).
Regarding claim 25, McIver and Gilbride, in combination, disclose the method of claim 21, wherein the anchor further comprises a plurality of grooves in an interior surface the curved partial-tubular shank (McIver’s curved shank modified to include Gilbride’s engagement fins protruding from interior and exterior surfaces thereof, as described above with respect to claim 1, comprises a plurality grooves, i.e. between the engagement fins, on an interior surface of the modified curved partial-tubular shank 112 of McIver).
Regarding claim 30, McIver and Gilbride, in combination, disclose the method of claim 21, and McIver teaches wherein the straight tapered tip portion comprises one or more reliefs (McIver, in para. 0060 and Fig. 8, discloses the straight tapered tip 802 as having a “double beveled profile” to effectively penetrate the vertebral body, the bevels defining a relief).
Claims 3, 6, 13, 16, 23 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over McIver (US 2022/0370203 A1) in view of Gilbride (US 2019/0000638 A1), as applied to claims 1, 11 and 21 above, respectively, further in view of Chataigner (US 2015/0209089 A1).
Regarding claim 3, McIver and Gilbride, in combination, disclose the anchor and interbody of claim 1.
In the combination described above, neither McIver nor Gilbride disclose wherein the anchor further comprises a plurality of indentations in an exterior surface of the curved partial-tubular shank.
Chataigner, in analogous art, teaches an anchor (1; Fig. 2A) for use with an interbody fusion cage (2; Fig. 2A; para. 0100), wherein the anchor comprises a plurality of indnetations in an exterior surface of a curved shank of the anchor (see catches 16, i.e. indentations, on external surface of anchor 1; Figs. 2A, 2C; para. 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved partial-tubular shank to include indentations on the exterior surface thereof, as taught by Chataigner, because Chataigner teaches that such features advantageously oppose withdrawal of the anchor once implanted in the vertebrae (see Chataigner, para. 0123).
Regarding claim 6, McIver and Gilbride, in combination, disclose the anchor and interbody of claim 1.
In the combination described above, neither McIver nor Gilbride disclose wherein the anchor further comprises porosity in an external surface, an internal surface, or both, of the curved partial-tubular shank.
Chataigner, in analogous art, teaches an anchor (1; Figs. 9A-D) for use with an interbody fusion cage (2; Figs. 9A-9B; para. 0121), wherein the anchor comprises porosity in a surface of the curved shank of the anchor (see Figs. 9C-9D, where holes 19 form a porosity in the surface of the curved shank of anchor 1; para. 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved partial-tubular shank to comprise Chataigner’s porosity in an exterior/interior surface of the curved partial-tubular shank, as claimed, because Chataigner discloses that providing such pores/holes allows bone growth through the anchoring device (see Chataigner, para. 0123).
Regarding claim 13, McIver and Gilbride, in combination, disclose the anchor and interbody kit of claim 11.
In the combination described above, neither McIver nor Gilbride disclose wherein the anchor further comprises a plurality of indentations in an exterior surface of the curved partial-tubular shank.
Chataigner, in analogous art, teaches an anchor (1; Fig. 2A) for use with an interbody fusion cage (2; Fig. 2A; para. 0100), wherein the anchor comprises a plurality of indnetations in an exterior surface of a curved shank of the anchor (see catches 16, i.e. indentations, on external surface of anchor 1; Figs. 2A, 2C; para. 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved partial-tubular shank to include indentations on the exterior surface thereof, as taught by Chataigner, because Chataigner teaches that such features advantageously oppose withdrawal of the anchor once implanted in the vertebrae (see Chataigner, para. 0123).
Regarding claim 16, McIver and Gilbride, in combination, disclose the anchor and interbody kitof claim 11.
In the combination described above, neither McIver nor Gilbride disclose wherein the anchor further comprises porosity in an external surface, an internal surface, or both, of the curved partial-tubular shank.
Chataigner, in analogous art, teaches an anchor (1; Figs. 9A-D) for use with an interbody fusion cage (2; Figs. 9A-9B; para. 0121), wherein the anchor comprises porosity in a surface of the curved shank of the anchor (see Figs. 9C-9D, where holes 19 form a porosity in the surface of the curved shank of anchor 1; para. 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved partial-tubular shank to comprise Chataigner’s porosity in an exterior/interior surface of the curved partial-tubular shank, as claimed, because Chataigner discloses that providing such pores/holes allows bone growth through the anchoring device (see Chataigner, para. 0123).
Regarding claim 23, McIver and Gilbride, in combination, disclose the method of claim 1.
In the combination described above, neither McIver nor Gilbride disclose wherein the anchor further comprises a plurality of indentations in an exterior surface of the curved partial-tubular shank.
Chataigner, in analogous art, teaches an anchor (1; Fig. 2A) for use with an interbody fusion cage (2; Fig. 2A; para. 0100), wherein the anchor comprises a plurality of indnetations in an exterior surface of a curved shank of the anchor (see catches 16, i.e. indentations, on external surface of anchor 1; Figs. 2A, 2C; para. 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved partial-tubular shank to include indentations on the exterior surface thereof, as taught by Chataigner, because Chataigner teaches that such features advantageously oppose withdrawal of the anchor once implanted in the vertebrae (see Chataigner, para. 0123).
Regarding claim 26, McIver and Gilbride, in combination, disclose the method of claim 21.
In the combination described above, neither McIver nor Gilbride disclose wherein the anchor further comprises porosity in an external surface, an internal surface, or both, of the curved partial-tubular shank.
Chataigner, in analogous art, teaches an anchor (1; Figs. 9A-D) for use with an interbody fusion cage (2; Figs. 9A-9B; para. 0121), wherein the anchor comprises porosity in a surface of the curved shank of the anchor (see Figs. 9C-9D, where holes 19 form a porosity in the surface of the curved shank of anchor 1; para. 0123).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved partial-tubular shank to comprise Chataigner’s porosity in an exterior/interior surface of the curved partial-tubular shank, as claimed, because Chataigner discloses that providing such pores/holes allows bone growth through the anchoring device (see Chataigner, para. 0123).
Claims 7, 17 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over McIver (US 2022/0370203 A1) in view of Gilbride (US 2019/0000638 A1), as applied to claims 1, 11 and 21 above, respectively, further in view of Lee (US 2022/0087821 A1).
Regarding claim 7, McIver and Gilbride, in combination, teach the anchor and interbody of claim 1.
In the combination, neither McIver nor Gilbride explicitly teach wherein an inner diameter and an outer diameter of the curved partial-tubular shank are not concentric, such that the curved partial-tubular shank varies in thickness.
Lee, in analogous art, teaches an anchor (100; Figs. 1A-1G; para. 0021) comprising a curved partial-tubular shank (shown as elongate body portion 104 between Figs. 1A-1G; para. 0022), wherein the inner diameter and outer diameter of the curved shank are not concentric, such that the curved shank varies in thickness (as best viewed in Figs. 1E-1G, the curved, partial-tubular shank varies in thickness, i.e. the inner diameter at the concave surface of shank 104 and the outer diameter at the convex surface of shank 104 are not concentric; also see Figs. 1A-D; para. 0025-0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed McIver’s curved partial tubular shank to have a varying thickness, decreasing towards the distal tip, as taught by Lee, because Lee recognizes that having a curved partial-tubular anchor shank configured in the claimed manner is a suitable shape for a curved partial-tubular shank intended to follow a trajectory into bony structure (see Lee, Abstract, Figs. 1A-1H).
Regarding claim 17, McIver and Gilbride, in combination, teach the anchor and interbody kit of claim 11.
In the combination, neither McIver nor Gilbride explicitly teach wherein an inner diameter and an outer diameter of the curved partial-tubular shank are not concentric, such that the curved partial-tubular shank varies in thickness.
Lee, in analogous art, teaches an anchor (100; Figs. 1A-1G; para. 0021) comprising a curved partial-tubular shank (shown as elongate body portion 104 between Figs. 1A-1G; para. 0022), wherein the inner diameter and outer diameter of the curved shank are not concentric, such that the curved shank varies in thickness (as best viewed in Figs. 1E-1G, the curved, partial-tubular shank varies in thickness, i.e. the inner diameter at the concave surface of shank 104 and the outer diameter at the convex surface of shank 104 are not concentric; also see Figs. 1A-D; para. 0025-0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed McIver’s curved partial tubular shank to have a varying thickness, decreasing towards the distal tip, as taught by Lee, because Lee recognizes that having a curved partial-tubular anchor shank configured in the claimed manner is a suitable shape for a curved partial-tubular shank intended to follow a trajectory into bony structure (see Lee, Abstract, Figs. 1A-1H).
Regarding claim 27, McIver and Gilbride, in combination, teach the method of claim 21.
In the combination, neither McIver nor Gilbride explicitly teach wherein an inner diameter and an outer diameter of the curved partial-tubular shank are not concentric, such that the curved partial-tubular shank varies in thickness.
Lee, in analogous art, teaches an anchor (100; Figs. 1A-1G; para. 0021) comprising a curved partial-tubular shank (shown as elongate body portion 104 between Figs. 1A-1G; para. 0022), wherein the inner diameter and outer diameter of the curved shank are not concentric, such that the curved shank varies in thickness (as best viewed in Figs. 1E-1G, the curved, partial-tubular shank varies in thickness, i.e. the inner diameter at the concave surface of shank 104 and the outer diameter at the convex surface of shank 104 are not concentric; also see Figs. 1A-D; para. 0025-0027).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed McIver’s curved partial tubular shank to have a varying thickness, decreasing towards the distal tip, as taught by Lee, because Lee recognizes that having a curved partial-tubular anchor shank configured in the claimed manner is a suitable shape for a curved partial-tubular shank intended to follow a trajectory into bony structure (see Lee, Abstract, Figs. 1A-1H).
Claims 8, 18 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over McIver (US 2022/0370203 A1) in view of Gilbride (US 2019/0000638 A1), as applied to claims 1, 11 and 21 above, respectively, further in view of Ameil (US 2017/0056198 A1).
Regarding claim 8, McIver and Gilbride, in combination, teach the anchor and interbody of claim 1.
In the combination, neither McIver nor Gilbride teach wherein the anchor further comprises an anchor locking tab configured to be depressed inward toward the head as the anchor is inserted into the interbody and the interbody further comprises a pocket configured to engage with the anchor locking tab when it springs outward once the anchor is inserted fully into the interbody.
Ameil, in analogous art, teaches a curved anchor (1; Figs. 3C-3F) for use with an interbody (2; Figs. 3A-3F), wherein the anchor comprises an anchor locking tab (defined by flexible tab abutment 12 on anchor 1, with slot 11; Fig. 3C; para. 0108) configured to be depressed inward toward the head as the anchor is inserted into the interbody, and the interbody further comprises a pocket configured to engage with the anchor locking tab when it springs outward once the anchor is inserted fully into the interbody (flexible tab abutment 12 is depressed inward as anchor 1 is inserted into interbody 2, where Fig. 3E shows interbody 2 comprising a pocket access 212 for engaging locking tab 12 once anchor 1 is fully inserted; para. 0108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved anchor to further include Ameil’s anchor locking tab proximate the head end thereof, configured in the claimed manner for engaging a pocket of the interbody once the anchor is fully inserted, because Ameil recognizes that such a configuration aids in immobilizing the anchor at the end of its deployment and preventing backout of the anchor (see Ameil, para. 0108, Figs. 3A-3F).
Regarding claim 18, McIver and Gilbride, in combination, teach the anchor and interbody kit of claim 11.
In the combination, neither McIver nor Gilbride teach wherein the anchor further comprises an anchor locking tab configured to be depressed inward toward the head as the anchor is inserted into the interbody and the interbody further comprises a pocket configured to engage with the anchor locking tab when it springs outward once the anchor is inserted fully into the interbody.
Ameil, in analogous art, teaches a curved anchor (1; Figs. 3C-3F) for use with an interbody (2; Figs. 3A-3F), wherein the anchor comprises an anchor locking tab (defined by flexible tab abutment 12 on anchor 1, with slot 11; Fig. 3C; para. 0108) configured to be depressed inward toward the head as the anchor is inserted into the interbody, and the interbody further comprises a pocket configured to engage with the anchor locking tab when it springs outward once the anchor is inserted fully into the interbody (flexible tab abutment 12 is depressed inward as anchor 1 is inserted into interbody 2, where Fig. 3E shows interbody 2 comprising a pocket access 212 for engaging locking tab 12 once anchor 1 is fully inserted; para. 0108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved anchor to further include Ameil’s anchor locking tab proximate the head end thereof, configured in the claimed manner for engaging a pocket of the interbody once the anchor is fully inserted, because Ameil recognizes that such a configuration aids in immobilizing the anchor at the end of its deployment and preventing backout of the anchor (see Ameil, para. 0108, Figs. 3A-3F).
Regarding claim 28, McIver and Gilbride, in combination, teach the method of claim 21.
In the combination, neither McIver nor Gilbride teach wherein the anchor further comprises an anchor locking tab configured to be depressed inward toward the head as the anchor is inserted into the interbody and the interbody further comprises a pocket configured to engage with the anchor locking tab when it springs outward once the anchor is inserted fully into the interbody.
Ameil, in analogous art, teaches a curved anchor (1; Figs. 3C-3F) for use with an interbody (2; Figs. 3A-3F), wherein the anchor comprises an anchor locking tab (defined by flexible tab abutment 12 on anchor 1, with slot 11; Fig. 3C; para. 0108) configured to be depressed inward toward the head as the anchor is inserted into the interbody, and the interbody further comprises a pocket configured to engage with the anchor locking tab when it springs outward once the anchor is inserted fully into the interbody (flexible tab abutment 12 is depressed inward as anchor 1 is inserted into interbody 2, where Fig. 3E shows interbody 2 comprising a pocket access 212 for engaging locking tab 12 once anchor 1 is fully inserted; para. 0108).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s curved anchor to further include Ameil’s anchor locking tab proximate the head end thereof, configured in the claimed manner for engaging a pocket of the interbody once the anchor is fully inserted, because Ameil recognizes that such a configuration aids in immobilizing the anchor at the end of its deployment and preventing backout of the anchor (see Ameil, para. 0108, Figs. 3A-3F).
Claims 9, 19 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over McIver (US 2022/0370203 A1) in view of Gilbride (US 2019/0000638 A1), as applied to claims 1, 11 and 21 above, respectively, further in view of Kirschman (US 2014/0277456 A1).
Regarding claim 9, McIver and Gilbride, in combination, disclose the anchor and interbody of claim 1.
In the combination, neither McIver nor Gilbride teach wherein the interbody further comprises an interbody locking tab configured to be moved outward while the head is being inserted into the interbody and to spring inward once the head is fully inserted into the interbody, engaging the head.
Kirschman, in analogous art, teaches an interbody (10; Figs. 1-12; para. 0034) and an anchor (50/52; Figs. 1-2; para. 0038), wherein the interbody comprises an interbody locking tab (arm 70/72; Figs. 1-2; para. 0042) configured to be moved outward while the head is being inserted into the interbody (as shown in the direction of arrow A in Fig. 5, described in para. 0050) and to spring inward once the head is fully inserted into the interbody, engaging the head (as shown in the direction of arrow B in Fig. 6, described in para. 0051-0053, engaging the head of the anchor as shown in Fig. 6A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s interbody to include a locking tab configured in the claimed manner, as taught by Kirschman, because Kirschman recognizes that such a configuration aids in preventing the anchors from withdrawing from the interbody and also facilitates preventing the anchors from splaying away from their respective axes/trajectories (see Kirschman, para. 0054).
Regarding claim 19, McIver and Gilbride, in combination, disclose the anchor and interbody kit of claim 11.
In the combination, neither McIver nor Gilbride teach wherein the interbody further comprises an interbody locking tab configured to be moved outward while the head is being inserted into the interbody and to spring inward once the head is fully inserted into the interbody, engaging the head.
Kirschman, in analogous art, teaches an interbody (10; Figs. 1-12; para. 0034) and an anchor (50/52; Figs. 1-2; para. 0038), wherein the interbody comprises an interbody locking tab (arm 70/72; Figs. 1-2; para. 0042) configured to be moved outward while the head is being inserted into the interbody (as shown in the direction of arrow A in Fig. 5, described in para. 0050) and to spring inward once the head is fully inserted into the interbody, engaging the head (as shown in the direction of arrow B in Fig. 6, described in para. 0051-0053, engaging the head of the anchor as shown in Fig. 6A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s interbody to include a locking tab configured in the claimed manner, as taught by Kirschman, because Kirschman recognizes that such a configuration aids in preventing the anchors from withdrawing from the interbody and also facilitates preventing the anchors from splaying away from their respective axes/trajectories (see Kirschman, para. 0054).
Regarding claim 29, McIver and Gilbride, in combination, disclose the method of claim 21.
In the combination, neither McIver nor Gilbride teach wherein the interbody further comprises an interbody locking tab configured to be moved outward while the head is being inserted into the interbody and to spring inward once the head is fully inserted into the interbody, engaging the head.
Kirschman, in analogous art, teaches an interbody (10; Figs. 1-12; para. 0034) and an anchor (50/52; Figs. 1-2; para. 0038), wherein the interbody comprises an interbody locking tab (arm 70/72; Figs. 1-2; para. 0042) configured to be moved outward while the head is being inserted into the interbody (as shown in the direction of arrow A in Fig. 5, described in para. 0050) and to spring inward once the head is fully inserted into the interbody, engaging the head (as shown in the direction of arrow B in Fig. 6, described in para. 0051-0053, engaging the head of the anchor as shown in Fig. 6A).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified McIver’s interbody to include a locking tab configured in the claimed manner, as taught by Kirschman, because Kirschman recognizes that such a configuration aids in preventing the anchors from withdrawing from the interbody and also facilitates preventing the anchors from splaying away from their respective axes/trajectories (see Kirschman, para. 0054).
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.
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/ANNA V. LITTLE/Examiner, Art Unit 3773 /EDUARDO C ROBERT/Supervisory Patent Examiner, Art Unit 3773
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