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 Amendment
This Office Action is responsive to the amendment filed on 02 March 2026. As directed by the amendment: claims 1, 5, 6, 10, 11, 16, 17, 24, 27, 29, and 31 have been amended and claim 32 is newly added. Claims 1-32 currently stand pending in the application.
Although the previous claim objection is withdrawn, further claim objections and a rejection under 35 U.S.C. 112(b) as necessitated by the claim amendments are presented below.
Response to Arguments
Examiner notes that the amendments to claims 1 and 17 have resulted in claim 17 no longer being commensurate with the subject matter previously objected to.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102(a)(1)/(2) and 35 U.S.C. 103 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.
Claim Objections
Claims 17 and 24-28 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 17 / line 2: “received in [[a]] the retaining channel”
Claim 24 / line 5: “the proximal end of the cage”
Claim 25 / line 2: “and the cage”
Claim 27 / line 2: “secured to [[the]] opposite lateral sidewalls”
Claim 28 / line 4: “and the cage”
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 20 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As to claim 20, the limitation “opposite lateral sidewalls of the vertebra” renders the claim indefinite because it is unclear if the lateral sidewalls refer back to the proximal and distal sidewalls of the vertebral body previously recited in claim 1, or to different lateral sidewalls. For examination purposes, the limitation will be interpreted as referring back to the proximal and distal sidewalls of the vertebral body.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-20 and 32 are rejected under 35 U.S.C. 102(a)(1) as anticipated by U.S. Patent No. US 6,287,308 to Betz et al. (hereinafter, “Betz”).
As to claim 1, Betz discloses an orthopedic implant device, FIG. 18, comprising: a cage (81; where a cage is an enclosure with some openwork); a staple (82 and 84) comprising a staple head (82) and a staple shaft (84) (col. 15 / lines 19-37); a coupling element (86) (col. 15 / lines 38-40); the staple shaft configured to rotate the staple head relative to the cage (interpreted as language of intended use; since the staple shaft and the staple head are welded together, rotating the staple shaft would rotate the staple head; the staple shaft is fully capable of rotating the staple head relative to the cage since the cage is loosely fit on the staple shaft); the staple shaft configured to rotate the staple head to a deployed position (interpreted as language of intended use; the staple shaft is fully capable of rotating the staple head to a deployed position since, as above, they are welded together; the shaft is fully capable of rotating the head for at least minute adjustments relative to the cage or bone); the staple shaft further configured to mate with the coupling element (col. 15 / lines 38-40), FIG. 18, whereby when the coupling element is rotated, the coupling element engages the staple shaft and the staple head is moved relative to the cage (col. 16 / lines 10-17; the coupling element is threadedly/rotationally advanced along the staple shaft to move the staple head and the cage and their respective prongs closer together); the cage is configured to extend across a portion of a vertebral body of a vertebra, shown for example in FIG. 19A; the portion of the vertebral body comprising an area between a proximal sidewall of the vertebral body and a distal sidewall of the vertebral body (where the proximal and distal locations are relative to a point of insertion); and the coupling element is received in a retaining channel (94) of the cage whereby a longitudinal position of the coupling element relative to the cage is constrained by the retaining channel, FIG. 18.
As to claim 2, Betz discloses the orthopedic implant device of claim 1 wherein the staple head is moved a distance relative to the cage without a rotation of the staple shaft (col. 16 / lines 10-17; the staple head is moved a distance relative to the cage without a rotation of the staple shaft because the coupling element rotates about/along the threads of the shaft to move the staple head and the cage and their respective prongs closer together).
As to claim 3, Betz discloses the orthopedic implant device of claim 1 wherein: a longitudinal axis of the cage (an axis along a prong of the cage 81 or through a middle of the retaining channel of the cage) is configured to extend laterally across the portion of the vertebral body of the vertebra, FIG. 19A.
As to claim 4, Betz discloses the orthopedic implant device of claim 3 wherein the orthopedic implant device is configured to be implanted from one of a lateral (FIG. 19A), an anterior or an oblique direction relative to the vertebral body (interpreted as language of intended use).
As to claim 5, Betz discloses the orthopedic implant device of claim 1 wherein: the staple shaft is configured to rotate the staple head from an extended position extended from the cage to the deployed position (interpreted as language of intended use; because the staple shaft is welded to the staple head, the shaft is fully capable of rotating the head from an extended position extended from the cage, e.g. FIG. 18 in which the head is extended distally relative to the cage, to the deployed position, e.g. minutely rotated relative to the cage, since the cage is loosely fit on the shaft); the extended position comprises a neutral alignment of the staple head (neutral or generally aligned with the cage in FIG. 18) and an extended location of the staple head extended a distance away from the cage (the head is in an extended position located distal relative to the cage, FIG. 18); and the deployed position comprises a non-neutral alignment of the staple head (at least minutely not aligned with the cage) and an extended location of the staple head away from the cage (as above, as in FIG. 18).
As to claim 6, Betz discloses the orthopedic implant device of claim 1 wherein the staple shaft is further configured to move the staple head from an insertion position to an extended position (interpreted as language of intended use; because the staple shaft is welded to the staple head, the shaft is fully capable of moving the staple head from an insertion position, e.g. the staple head closer to the cage with the shaft and coupling element further proximal to the cage, to an extended position, e.g. FIG. 18 in which the head is extended distally relative to the cage).
As to claim 7, Betz discloses the orthopedic implant device of claim 6 wherein: the insertion position comprises a neutral alignment of the staple head (neutral or generally aligned with the cage in FIG. 18) and a non-extended location relative to the cage (closer to the cage); and the extended position comprises a neutral alignment of the staple head and an extended location of the staple head away from the cage (the head is in an extended position located distal relative to the cage, FIG. 18).
As to claim 8, Betz discloses the orthopedic implant device of claim 1 wherein the staple shaft is further configured to move the staple head from the deployed position to a stabilization position (interpreted as language of intended use; because the staple shaft is welded to the staple head, the shaft is fully capable of moving the head from the deployed position, e.g. minutely rotated relative to the cage, since the cage is loosely fit on the shaft, to a stabilization position, e.g. the coupling element threaded toward the staple head to move the staple head and the cage and their respective prongs closer together).
As to claim 9, Betz discloses the orthopedic implant device of claim 8 wherein: the deployed position comprises a non-neutral alignment of the staple head and an extended location of the staple head away from the cage (as above); and the stabilization position comprises a non-neutral alignment of the staple head (at least minutely not aligned with the cage) and a retracted location of the staple head retracted towards the cage (col. 16 / lines 10-17).
As to claim 10, Betz discloses the orthopedic implant device of claim 1 wherein: the staple shaft is received in a through bore (93) of the cage; and the staple shaft is rotatable within the through bore of the cage (since the cage is loosely fit on the shaft), FIG. 18, whereby the staple shaft is configured to move the staple head to the deployed position relative to the cage (interpreted as language of intended use; fully capable since they are welded together).
As to claim 11, Betz discloses the orthopedic implant device of claim 1 wherein: the staple shaft is received in a through bore (93) of the cage; and the staple shaft is longitudinally slidable within the through bore of the cage (since the cage is loosely fit on the shaft), FIG. 18, whereby the staple shaft is configured to slidably move the staple head from an insertion position to an extended position extended away from the cage (interpreted as language of intended use; fully capable since they are welded together).
As to claim 12, Betz discloses the orthopedic implant device of claim 1 wherein: the staple shaft is received in a through bore (93) of the cage; and the staple shaft is longitudinally slidable within the through bore of the cage (since the cage is loosely fit on the shaft), FIG. 18, whereby the staple shaft is configured to slidably move the staple head from the deployed position to a stabilization position retracted towards the cage (interpreted as language of intended use; fully capable since they are welded together).
As to claim 13, Betz discloses the orthopedic implant device of claim 1 wherein the coupling element comprises a threaded nut (86) (col. 15 / lines 38-40).
As to claim 14, Betz discloses the orthopedic implant device of claim 13 wherein: the staple shaft having a threaded portion (91); and the threaded nut configured to mate with the threaded portion of the staple shaft (col. 15 / lines 38-40) whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is moved away from the cage (interpreted as language of intended use; when the threaded nut is rotated in one direction, and the prongs of the staple head and the cage are already inserted in bone, the staple head is fully capable of being moved away from the cage as the staple shaft threads out of the threaded nut and pushes the staple head further distal away from the cage).
As to claim 15, Betz discloses the orthopedic implant device of claim 13 wherein: the staple shaft having a threaded portion (91); and the threaded nut configured to mate with the threaded portion of the staple shaft (col. 15 / lines 38-40) whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is retracted towards the cage (col. 16 / lines 10-17).
As to claim 16, Betz discloses the orthopedic implant device of claim 13 wherein: the staple shaft having a threaded portion (91) and an engagement portion (92), FIG. 18; the engagement portion of the staple shaft configured to be engaged by a shaft engagement portion of an engagement tool (interpreted as language of intended use; fully capable of being engaged and rotated by an engagement tool of complementary shape and size) whereby the shaft engagement portion of the engagement tool is configured to rotate the staple shaft and move the staple head to the deployed position (interpreted as language of intended use); the threaded nut is configured to be engaged by a nut engagement portion of an engagement tool to rotate the threaded nut (interpreted as language of intended use; fully capable of being engaged by an engagement tool); the threaded nut is configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated in a first direction, the threaded nut engages the threaded portion of the staple shaft and the staple head is extended away from the cage (interpreted as language of intended use; when the threaded nut is rotated in one direction, and the prongs of the staple head and the cage are already inserted in bone, the staple head is fully capable of being extended away from the cage as the staple shaft threads out of the threaded nut and pushes the staple head further distal away from the cage); and the threaded nut is configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated in a second direction, the threaded nut engages the threaded portion of the staple shaft and the staple head is retracted towards the cage (col. 16 / lines 10-17).
As to claim 17, Betz discloses the orthopedic implant device of claim 13 wherein: the threaded nut is received in a retaining channel (94) of the cage whereby the longitudinal position of the threaded nut relative to the cage is constrained by the retaining channel (the threaded nut is constrained from moving further distally in the longitudinal direction once it abuts the retaining channel); and the staple is configured to secure the orthopedic implant device to the distal sidewall of the vertebral body (interpreted as language of intended use), FIG. 19A.
As to claim 18, Betz discloses the orthopedic implant device of claim 1 further comprising an anchor frame (prongs at the ends of the cage), FIG. 18.
As to claim 19, Betz discloses the orthopedic implant device of claim 18 wherein the anchor frame is (integrally) coupled to the cage.
As to claim 20, Betz discloses the orthopedic implant device of claim 18 wherein the staple head and the anchor frame are configured to be secured to opposite lateral sidewalls of the vertebra by a compressive force (col. 16 / lines 10-17), FIG. 19A.
As to claim 32, Betz discloses an orthopedic implant device, FIG. 18, comprising: a cage (81; where a cage is an enclosure with some openwork) having a proximal end and a distal end; a staple (82 and 84) comprising a staple head (82) and a staple shaft (84) (col. 15 / lines 19-37); a coupling element (86) (col. 15 / lines 38-40); the cage is configured to extend across a portion of a vertebral body of a vertebra, shown for example in FIG. 19A; the portion of the vertebral body comprising an area between a proximal sidewall of the vertebral body and a distal sidewall of the vertebral body (where the proximal and distal locations are relative to a point of insertion); the staple shaft is configured to rotate the staple head relative to the cage (interpreted as language of intended use; since the staple shaft and the staple head are welded together, rotating the staple shaft would rotate the staple head; the staple shaft is fully capable of rotating the staple head relative to the cage since the cage is loosely fit on the staple shaft); the staple shaft is configured to rotate the staple head to a deployed position (interpreted as language of intended use; the staple shaft is fully capable of rotating the staple head to a deployed position since, as above, they are welded together; the shaft is fully capable of rotating the head for at least minute adjustments relative to the cage or bone); the coupling element is configured to be manipulated from the proximal end of the cage, FIG. 18; and the coupling element comprises a nut (86) configured to engage the staple shaft at a location between the proximal end of the cage and the distal end of the cage, FIG. 18, whereby when the coupling element is rotated, the coupling element engages the staple shaft and the staple head is moved relative to the cage (col. 16 / lines 10-17; the coupling element is threadedly/rotationally advanced along the staple shaft to move the staple head and the cage and their respective prongs closer together).
Claims 29-31 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,283,084 to O’Hara.
As to claim 29, O’Hara discloses a method to secure a first bone portion to a second bone portion (adjacent vertebrae 11), FIGS. 1A-1D, the method comprising: providing an orthopedic implant device comprising: a cage (10), a staple (35 and 41) (col. 5 / line 42 – col. 6 / line 25), a coupling element (53) (col. 6 / lines 38-43) and an anchor frame (43), FIG. 1C; the cage coupled to the anchor frame and the staple (at least as part of the functional whole, and also frictionally in FIGS. 1A-1B), the staple comprising a staple head (41) and a staple shaft (35), the staple head rigidly coupled to the staple shaft (the staple head 41 is rigidly coupled to the staple shaft 35 so that rotation of the shaft effects rotation of the staple head, col. 6 / lines 20-25; the staple head and shaft are also rigidly coupled upon complete fixation of the staple and the anchor frame on the bone portions since the entire device is rigidly coupled) whereby the staple head extends at a fixed angle to a longitudinal axis of the staple shaft (since the head and shaft are keyed together, and also upon complete fixation of the staple and the anchor frame on the bone portions) and the staple head is in a fixed rotational position about the longitudinal axis of the staple shaft relative to the staple shaft when the staple head and the staple shaft are rotated (since the head and shaft are keyed together), the coupling element coupled to the staple shaft, FIG. 1C, and configured to engage the staple shaft and operably couple the staple to the cage (as part of the functional whole that is operably coupled all together), FIG. 1C, whereby the coupling element adjusts a positional relationship of the staple head and the anchor frame (col. 6 / lines 40-43), and the anchor frame is coupled to the cage in a fixed rotational position relative to the longitudinal axis of the cage whereby the anchor frame does not rotate about the longitudinal axis of the cage (upon complete fixation of the staple and the anchor frame on the bone portions, the anchor frame does not further rotate); inserting the cage and the staple into an opening between the first bone portion and the second bone portion, FIG. 1A; and securing the anchor frame to the first bone portion and the second bone portion by retracting the staple head towards the cage and/or the anchor frame (col. 6 / lines 40-43; the staple head and the anchor frame move toward each other).
As to claim 30, O’Hara discloses the method of claim 29 further comprising positioning the staple in a stabilized position (relative to the anchor frame, when the staple head and the anchor frame have moved toward each other) to secure the staple to the first bone portion and the second bone portion whereby the staple further secures the cage to the first and the second bone portions, FIG. 1C.
As to claim 31, O’Hara discloses an orthopedic implant device, FIGS. 1A-1D, comprising: a cage (10); a staple (35 and 41) (col. 5 / line 42 – col. 6 / line 25) comprising a staple head (41) rigidly fixed to a staple shaft (35) (the staple head 41 is rigidly fixed to the staple shaft 35 so that rotation of the shaft effects rotation of the staple head, col. 6 / lines 20-25; the staple head and shaft are also rigidly fixed upon complete fixation of the staple and the anchor frame on the bone portions since the entire device is rigidly coupled); the staple head rigidly extending at a fixed angle to a longitudinal axis of the staple shaft (since the head and shaft are keyed together, and also upon complete fixation of the staple and the anchor frame on the bone portions); the staple head rigidly extending in a fixed rotational position about the longitudinal axis of the staple shaft (since the head and shaft are keyed together); an anchor frame (43) coupled to the cage in a fixed rotational position relative to the longitudinal axis of the staple shaft whereby the anchor frame does not rotate about the longitudinal axis of the staple shaft (upon complete fixation of the staple and the anchor frame on the bone portions, the anchor frame does not further rotate); a coupling element (53) (col. 6 / lines 38-43); the staple shaft configured to rotate the staple head relative to the cage (col. 6 / lines 20-25); the staple shaft configured to rotate the staple head from an extended position extended from the cage (extended out from indentations 55 in the cage, and/or in an extended position distal relative to the cage) to a deployed position (rotated to engage the vertebrae) (col. 6 / lines 49-56); and the staple shaft is further configured to mate with the coupling element whereby when the coupling element is engaged, the coupling element engages the staple shaft and the staple head is moved a distance relative to the cage (the staple head and the anchor frame move closer together and compress against the cage).
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.
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 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2016/0331544 to Braddock, JR. et al. (hereinafter, “Braddock”) in view of U.S. Patent No. US 6,287,308 to Betz et al. (hereinafter, “Betz”).
As to claim 24, Braddock discloses an orthopedic implant device, FIGS. 10-15, comprising: a cage (114) (par. [0058]) having a proximal end and a distal end; the cage having a longitudinal axis generally extending from the proximal end of the cage to the distal end of the cage; an anchor frame (160) positioned closer to the proximal end of cage than the distal end of the cage; a staple (140 and 158) comprising a staple head (140) and a staple shaft (158) (par. [0061]-[0063]); the staple head positioned closer to the distal end of the cage than the proximal end of the cage; a coupling element (170) (par. [0066]) is configured to be manipulated from the proximal end of the cage; the coupling element configured to engage the staple shaft (threadedly) and operably couple the staple to the cage (as part of the operable whole; the coupling element prevents the staple from disengaging from the cage) whereby the coupling element adjusts a positional relationship of the staple head and the cage (by compressing the components towards each other, par. [0066]); and the anchor frame, the staple, the coupling element and the cage operably coupled (as part of the functional whole, FIG. 15).
As to claim 25, Braddock discloses the orthopedic implant device of claim 24 wherein the coupling element adjusts the positional relationship of the staple head and the anchor frame (by compressing them together) without a rotation of the staple shaft (since the coupling element is rotating).
As to claim 26, Braddock discloses the orthopedic implant device of claim 24 wherein: the cage comprises a through bore extending longitudinally through the cage; the staple shaft received in the through bore to operably couple the cage and the staple (as parts of the functional whole); and the anchor frame operably coupled to the cage, FIG. 15, whereby the anchor frame, the staple and the cage are operably coupled, FIG. 15.
As to claim 27, Braddock discloses the orthopedic implant device of claim 24 wherein the staple head and the anchor frame are configured to be secured to the opposite lateral sidewalls of a portion of a vertebral body by a compressive force (par. [0066]).
As to claim 28, Braddock discloses the orthopedic implant device of claim 24 wherein: the coupling element comprises a threaded nut configured to engage a threaded portion of the staple shaft whereby the coupling element adjusts the positional relationship of the staple head and the anchor frame (in compression, par. [0066]).
Braddock is silent as to the anchor frame pivots about an axis about ninety degrees to the longitudinal axis of the cage.
Betz teaches an orthopedic implant device, FIG. 18, comprising: an anchor frame (81) that pivots about an axis about ninety degrees to a longitudinal axis of a threaded staple shaft (84), so that an outer face of the anchor frame need not be in a plane perpendicular to the longitudinal axis while still allowing good anchorage in the bone (col. 15 / lines 52-64), by providing play between a coupling element (86) that threads along the threaded staple shaft and an aperture through the anchor frame into which the coupling element is disposed. In order to tilt the anchor frame so that its outer face is not in a plane perpendicular to the longitudinal axis, the anchor frame would pivot about an axis passing through and about ninety degrees to the longitudinal axis, since the anchor frame pivots about the staple shaft.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Braddock’s anchor frame, staple shaft, and coupling element in view of Betz so that there is play between the coupling element, which would be modified to have a distal portion that extends through the anchor frame, and the aperture through the anchor frame, so that the anchor frame can pivot about an axis about ninety degrees to the longitudinal axis of the staple shaft and cage (which are collinear) as may be needed for the prongs on the anchor frame to obtain purchase on uneven bone surfaces, while still allowing a shoulder on the coupling element to engage a chamfer in the anchor frame aperture to fully seat the device and compress the anchor frame and staple head together to compress the underlying bone portions. As required by both Braddock and Betz, the coupling element would still thread along the threaded staple shaft to compress the components of the device together.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. US 2016/0331544 to Braddock, JR. et al. (hereinafter, “Braddock”) in view of U.S. Patent Application Publication No. US 2013/0073045 to Vestgaarden and U.S. Patent No. US 6,287,308 to Betz et al. (hereinafter, “Betz”).
As to claim 1, Braddock discloses an orthopedic implant device, FIGS. 10-15, comprising: a cage (114) (par. [0058]); a staple (140 and 158) comprising a staple head (140) and a staple shaft (158) (par. [0061]-[0063]); a coupling element (170) (par. [0066]); the staple shaft configured to rotate the staple head relative to the cage, FIGS. 11-12; the staple shaft configured to rotate the staple head to a deployed position, FIG. 12; the staple shaft further configured to mate with the coupling element whereby when the coupling element is rotated, the coupling element engages the staple shaft (threadedly) and the staple head is moved relative to the cage (staple head is compressed toward cage, par. [0066]), FIG. 15; the cage is configured to extend across a portion of a vertebral body of a vertebra, shown for example in FIG. 9; the portion of the vertebral body comprising an area between a proximal sidewall of the vertebral body and a distal sidewall of the vertebral body.
As to claim 2, Braddock discloses the orthopedic implant device of claim 1 wherein the staple head is moved a distance relative to the cage without a rotation of the staple shaft (movement of the staple head from the position of FIG. 10 to the position of FIG. 11 or from FIG. 12 to FIG. 13 relative to the cage requires only translation of the staple shaft and the connected staple head; additionally, torqueing and tightening of the coupling element 170 compresses the staple head toward the vertebrae and the cage, without rotating the staple shaft, par. [0066]).
As to claim 3, Braddock discloses the orthopedic implant device of claim 1 wherein: a longitudinal axis of the cage is configured to extend laterally across the portion of the vertebral body of the vertebra.
As to claim 4, Braddock discloses the orthopedic implant device of claim 3 wherein the orthopedic implant device is configured to be implanted from one of a lateral, an anterior or an oblique direction relative to the vertebral body (lateral direction shown in FIG. 9).
As to claim 5, Braddock discloses the orthopedic implant device of claim 1 wherein: the staple shaft is configured to rotate the staple head from an extended position extended from the cage to the deployed position; the extended position, FIG. 11, comprises a neutral alignment of the staple head and an extended location of the staple head extended a distance away from the cage; and the deployed position, FIG. 12, comprises a non-neutral alignment of the staple head and an extended location of the staple head away from the cage.
As to claim 6, Braddock discloses the orthopedic implant device of claim 1 wherein the staple shaft is further configured to move the staple head from an insertion position, FIG. 10, to an extended position, FIG. 11.
As to claim 7, Braddock discloses the orthopedic implant device of claim 6 wherein: the insertion position, FIG. 10, comprises a neutral alignment of the staple head and a non-extended location relative to the cage; and the extended position, FIG. 11, comprises a neutral alignment of the staple head and an extended location of the staple head away from the cage.
As to claim 8, Braddock discloses the orthopedic implant device of claim 1 wherein the staple shaft is further configured to move the staple head from the deployed position, FIG. 12, to a stabilization position, FIG. 13.
As to claim 9, Braddock discloses the orthopedic implant device of claim 8 wherein: the deployed position, FIG. 12, comprises a non-neutral alignment of the staple head and an extended location of the staple head away from the cage; and the stabilization position, FIG. 13, comprises a non-neutral alignment of the staple head and a retracted location of the staple head retracted towards the cage.
As to claim 10, Braddock discloses the orthopedic implant device of claim 1 wherein: the staple shaft is received in a through bore of the cage; and the staple shaft is rotatable within the through bore of the cage whereby the staple shaft is configured to move the staple head to the deployed position relative to the cage, FIGS. 11-12.
As to claim 11, Braddock discloses the orthopedic implant device of claim 1 wherein: the staple shaft is received in a through bore of the cage; and the staple shaft is longitudinally slidable within the through bore of the cage whereby the staple shaft is configured to slidably move the staple head from an insertion position, FIG. 10, to an extended position, FIG. 11, extended away from the cage.
As to claim 12, Braddock discloses the orthopedic implant device of claim 1 wherein: the staple shaft is received in a through bore of the cage; and the staple shaft is longitudinally slidable within the through bore of the cage whereby the staple shaft is configured to slidably move the staple head from the deployed position, FIG. 12, to a stabilization position, FIG. 13, retracted towards the cage.
As to claim 13, Braddock discloses the orthopedic implant device of claim 1 wherein the coupling element (170) comprises a threaded nut.
As to claim 14, Braddock discloses the orthopedic implant device of claim 13 wherein: the staple shaft (158) having a threaded portion; and the threaded nut configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is moved away from the cage (threading the threaded nut along the threaded portion of the staple shaft away from the cage provides space for the staple head to be moved away from the cage, e.g. FIGS. 10-11; additionally or alternatively, rotating the threaded nut in a certain direction against the anchor frame would cause the threaded staple shaft to thread out of the nut to move the staple head away from the other end of the cage).
As to claim 15, Braddock discloses the orthopedic implant device of claim 13 wherein: the staple shaft having a threaded portion; and the threaded nut configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated, the threaded nut engages the threaded portion of the staple shaft and the staple head is retracted towards the cage (into compression, par. [0066]).
As to claim 16, Braddock discloses the orthopedic implant device of claim 13 wherein: the staple shaft having a threaded portion and an engagement portion (proximal end); the engagement portion of the staple shaft configured to be engaged by a shaft engagement portion of an engagement tool (interpreted as language of intended use; fully capable of being engaged and rotated by an engagement tool of complementary shape and size) whereby the shaft engagement portion of the engagement tool is configured to rotate the staple shaft and move the staple head to the deployed position (interpreted as language of intended use); the threaded nut is configured to be engaged by a nut engagement portion of an engagement tool to rotate the threaded nut (interpreted as language of intended use; fully capable of being engaged by an engagement tool); the threaded nut is configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated in a first direction, the threaded nut engages the threaded portion of the staple shaft and the staple head is extended away from the cage (threading the threaded nut along the threaded portion of the staple shaft away from the cage provides space for the staple head to be extended away from the cage; if the threaded nut and the cage remain at a fixed distance relative to each other, such as by being held between the vertebrae, rotating the threaded nut in the first direction would cause the staple shaft to thread out of the cage and the staple head at the end of the staple shaft to extend away from the cage); and the threaded nut is configured to mate with the threaded portion of the staple shaft whereby when the threaded nut is rotated in a second direction, the threaded nut engages the threaded portion of the staple shaft and the staple head is retracted towards the cage (threading the threaded nut toward the cage in the second direction along the staple shaft retracts the staple head into compression).
As to claim 17, Braddock discloses the orthopedic implant device of claim 13 wherein: the staple is configured to secure the orthopedic implant device to the distal sidewall of the vertebral body, e.g. FIG. 9.
As to claim 18, Braddock discloses the orthopedic implant device of claim 1 further comprising an anchor frame (160).
As to claim 19, Braddock discloses the orthopedic implant device of claim 18 wherein the anchor frame is coupled to the cage (functionally and frictionally, in FIG. 15).
As to claim 20, Braddock discloses the orthopedic implant device of claim 18 wherein the staple head and the anchor frame are configured to be secured to opposite lateral sidewalls of the vertebra by a compressive force (par. [0066]).
As to claim 21, Braddock discloses the orthopedic implant device of claim 1 further comprising an anchor frame (160) pivotally coupled to the cage (pivots about axis of 158), FIGS. 13-14.
As to claim 23, Braddock discloses the orthopedic implant device of claim 1 wherein: the cage further comprising at least one cage stop (128); the staple shaft coupled to a key (protruding tips on staple head 140 which extend into the cage stop and which are coupled to the staple shaft since the staple head is coupled to the staple shaft); and the at least one cage stop configured to engage the key (par. [0063]), FIG. 10, to influence a movement of the staple head relative to the cage (since the staple head is prevented from moving further proximally relative to the cage when the cage stop and key are engaged).
Assuming arguendo, Braddock is silent as to the staple shaft configured to rotate the staple head relative to the cage (claim 1).
Vestgaarden teaches an orthopedic implant device, FIGS. 12-13, comprising: a cage (10); a staple comprising a staple head (35) and a staple shaft (55); the staple shaft configured to rotate the staple head relative to the cage (par. [0078]-[0079]); the staple shaft configured to rotate the staple head to a deployed position (misaligned to cage) (par. [0078]); the cage is configured to extend across a portion of a vertebral body of a vertebra; the portion of the vertebral body comprising an area between a proximal sidewall of the vertebral body and a distal sidewall of the vertebral body.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have Braddock’s staple shaft engaged to the staple head such that manipulation of the staple shaft applies the rotational force to the staple head, so that the staple head can be rotated and deployed into position by manipulation of the staple shaft at the proximal end of the device, therefore requiring only one incision on the proximal side of the spine and resulting in greater minimal invasiveness to the patient. Any friction between the staple shaft and the staple head would achieve this rotation, and would also prevent the staple head from falling under gravitational force back from the deployed position to the extended position. The staple shaft would thus be configured to rotate the staple head in Braddock from the extended position to the deployed position, thus improving the minimal invasiveness of the procedure since a tool need not be applied to both sides of the vertebral body.
Braddock is silent as to the coupling element is received in a retaining channel of the cage whereby a longitudinal position of the coupling element relative to the cage is constrained by the retaining channel (claim 1); the threaded nut is received in a retaining channel of the cage whereby the longitudinal position of the threaded nut relative to the cage is constrained by the retaining channel (claim 17); wherein the anchor frame pivots about an axis about ninety degrees to a longitudinal axis of the cage (claim 22).
Betz teaches an orthopedic implant device, FIG. 18, comprising: an anchor frame (81) that pivots about an axis about ninety degrees to a longitudinal axis of a threaded staple shaft (84), so that an outer face of the anchor frame need not be in a plane perpendicular to the longitudinal axis while still allowing good anchorage in the bone (col. 15 / lines 52-64), by providing play between a coupling element (86) that threads along the threaded staple shaft and an aperture through the anchor frame into which the coupling element is disposed. In order to tilt the anchor frame so that its outer face is not in a plane perpendicular to the longitudinal axis, the anchor frame would pivot about an axis passing through and about ninety degrees to the longitudinal axis, since the anchor frame pivots about the staple shaft.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Braddock’s anchor frame, staple shaft, and coupling element in view of Betz so that there is play between the coupling element, which would be modified to have a distal portion that extends through the anchor frame, and the aperture through the anchor frame, so that the anchor frame is pivotally coupled to the cage and can pivot about an axis about ninety degrees to the longitudinal axis of the staple shaft and cage (which are collinear) as may be needed for the prongs on the anchor frame to obtain purchase on uneven bone surfaces, while still allowing a shoulder on the coupling element to engage a chamfer in the anchor frame aperture to fully seat the device and compress the anchor frame and staple head together to compress the underlying bone portions. As required by both Braddock and Betz, the coupling element would still thread along the threaded staple shaft to compress the components of the device together. Since Braddock’s anchor frame abuts the cage in the compressed stabilization position, and Betz teaches that the distal portion of the coupling element extends through the anchor frame and distally out of the aperture in the anchor frame, it would have been further obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Braddock’s cage with a retaining channel that receives the distal portion of the coupling element/threaded nut at least in the compressed stabilization position when the distal portion of the coupling element extends through the anchor frame and distally out of the aperture in the anchor frame, so that the anchor frame can abut against the cage. The retaining channel would thus constrain a longitudinal position of the coupling element relative to the cage since it would at least prevent further longitudinal movement of the coupling element into the cage.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
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