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 03 November 2025. As directed by the amendment: claims 1, 5, 9, and 13 have been amended, claims 2-4, 10-12, and 21 are cancelled, and claims 23-28 are newly added. Claims 1, 5-9, 13-20, and 22-28 currently stand pending in the application.
The amendments to the claims are not sufficient to overcome the drawing objections listed in the previous action, which are repeated below in relevant part.
The amendments to the claims are not sufficient to overcome the rejections under 35 U.S.C. 112(a) listed in the previous action, which are repeated below in relevant part, in addition to further rejections under 35 U.S.C. 112(a), resulting from the current amendments.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b) listed in the previous action, which are accordingly withdrawn. However, further rejections under 35 U.S.C. 112(b), resulting from the current amendments, are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections of claim 1 under 35 U.S.C. 103 have been fully considered but they are not persuasive. As to Ono (US 10,085,784), Applicant contends that the fitting section 1 does not extend across openings defined by edges of the reverse-engineering surface approximation. Applicant contends that there is no other structure in Ono having edges that define opposing openings for Ono’s fitting section 1 to extend across, nor do any end walls extend across openings defined by edges of Ono’s fitting section 1. Examiner respectfully submits that these claimed limitations comprise new matter, and are not disclosed in the instant application. The instant specification does not describe edges of the reverse-engineering surface approximation of the interior surface, nor openings at opposite ends of the drill guide device, and does not describe end walls extending across the openings. The only embodiment that references end walls is FIG. 8, which does not show or describe edges defining openings at opposite ends of the drill guide device, nor that the end walls extend across those openings. Therefore, Ono discloses the claimed limitations at least as much as the instant application, as best understood. Ono’s end walls (in the perspective of FIG. 1, the walls forming the left and right sides/downwardly extending ends of the cap/hooded portion of 1 that face each other and extend down along 2’s) extend across openings (openings or concavities that are recessed into the interior surface on the ends of 1, on the interior of the convex protruding ends of 1) at opposite ends of the drill guide device because the end walls extend across or from one side to the other of the openings since each end wall extends across or along the side of one of the openings to form another side of the opening and thus enclose the protruding boney structure.
As to Frey ‘678 (US 9,198,678), Frey ‘105 (US 2020/0360105), and Bono (US 2020/0138592), Applicant contends that they do not disclose any end walls extending across opposing openings defined by edges. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). These references are not relied upon to teach this feature.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the following must be shown or the feature(s) canceled from the claim(s):
the parallel links and the adjacent boney structure protector (claim 5, shown in FIG. 9B) in the same embodiment as end walls (claim 1, shown in FIG. 8);
a robotic effector interface (claim 22, FIG. 11B) in the same embodiment as end walls (claim 1, shown in FIG. 8);
forming at least one adjacent boney structure protector (claim 13, shown in FIG. 9B) in the same embodiment as forming end walls (claim 9, shown in FIG. 8)
No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 9, 13-16, and 26-28 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 9 / line 11: “reverse-engineering
Claim 9 / line 16: “across the openings at the opposite ends”
Claim 26 / line 1: “wherein the forming of the end walls”
Claim 26 / line 2: “forming the end walls”
Claim 27 / line 1: “wherein the forming of the end walls”
Claim 27 / line 2: “forming the end walls”
Claim 28 / line 1: “wherein the forming of the end walls”
Claim 28 / line 2: “forming the end walls”
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 5-9, 13-20, and 22-28 are rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 1 and 9, the specification is silent as to “edges of the reverse-engineering surface approximation of the interior surface define openings at opposite ends of the drill guide device; wherein the end walls extend across the openings to enclose the protruding boney structure”. The specification does not describe edges of the reverse-engineering surface approximation of the interior surface, nor openings at opposite ends of the drill guide device, and does not describe end walls extending across the openings. The only embodiment that references end walls is FIG. 8, which does not show or describe edges defining openings at opposite ends of the drill guide device, nor that the end walls extend across those openings.
As to claim 5, the specification is silent as to parallel links extending to at least one adjacent boney structure protector (FIG. 9B) in the same embodiment as end walls, as previously recited in claim 1 and shown in FIG. 8.
As to claim 13, the specification is silent as to forming at least one adjacent boney structure protector (FIG. 9B), in the same embodiment as end walls, as previously recited in claim 9 and shown in FIG. 8.
As to claim 22, the specification is silent as to a robotic effector interface extending from the outer surface of the body (FIG. 11B) in the same embodiment as end walls, as previously recited in claim 1 and shown in FIG. 8.
As to claim 23 and 26, the specification is silent as to the edges of the end walls conform to the protruding boney structure. The only embodiment that references end walls is FIG. 8, which does not show or describe edges of the end walls conforming to the protruding boney structure.
As to claims 24 and 27, the specification is silent as to the end walls are substantially planar. The only embodiment that references end walls is FIG. 8, which does not show or describe the end walls being substantially planar.
As to claims 25 and 28, the specification is silent as to the end walls are substantially parallel to each other. The only embodiment that references end walls is FIG. 8, which does not show or describe the end walls being substantially parallel to each other, since only one end wall 820 is shown.
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.
Claims 1, 5-9, 13-20, and 22-28 are 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 claims 1 and 9, the limitations “edges of the reverse-engineering surface approximation of the interior surface define openings at opposite ends of the drill guide device; wherein the end walls extend across the openings to enclose the protruding boney structure” render the claims indefinite because it is unclear how an edge can define an opening (is the opening through the edge or is the edge around the opening), and how end walls can extend across the openings, where the term across implies that the end walls cut across or traverse the openings. Since the limitations are also not supported by the specification, understanding of the limitations is limited.
As to claim 23 and 26, the limitation “the edges of the end walls” render the claims indefinite because they lack proper antecedent basis. The edges previously recited in claims 1 and 9 are of the reverse-engineering surface approximation of the interior surface, not of the end walls. For examination purposes, the limitation will be interpreted as edges of the end walls. However, this interpretation does not remedy the relevant rejection under 35 U.S.C. 112(a) presented above; amendment is required.
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, 7, 8, and 23-25 are rejected under 35 U.S.C. 102(a)(1)/(2) as being anticipated by U.S. Patent No. US 10,085,784 to Ono et al. (hereinafter, “Ono”).
As to claim 1, Ono discloses a surgical bone-protecting drill guide device, comprising: a body (A) formed of biocompatible material forming a shell (col. 7 / lines 3-9), FIGS. 1-2, the body including: an outer surface (outwardly facing surfaces away from bone), an interior surface (inwardly facing surfaces of 1 and 2 facing toward bone) being a reverse-engineering surface approximation of a protruding boney structure of one or more bones in an image of a patient (col. 16 / lines 11-27), FIGS. 1-4 and 8, and end walls (in the perspective of FIG. 1, the walls forming the left and right sides/downwardly extending ends of the cap/hooded portion of 1 that face each other and extend down along 2’s) configured to enclose the protruding boney structure; body material between the outer surface and the interior surface (col. 16 / lines 23-24), and a plurality of holes (cannulation through 2’s) (col. 8 / lines 36-44) extending through a thickness of the body material from the outer surface to the interior surface, wherein each of the plurality of holes is configured to provide a window to a pre-planned implant location for implanting a respective one implant (screw) relative to the protruding boney structure of the patient (col. 1 / lines 29-36; col. 16 / lines 24-27), wherein the reverse-engineering surface approximation of the interior surface is configured to conform to the protruding boney structure along a continuous path from a first hole of the plurality of holes to a second hole of the plurality of holes (since the reverse-engineering surface approximation extends along a continuous path from one 2 to the other 2, shown in FIGS. 1-2), such that edges (in the perspective of FIG. 1, the edges are along and form the ends of 1 adjacent the 2’s, behind the downwardly extending end walls) of the reverse-engineering surface approximation of the interior surface define openings (openings or concavities that are recessed into the interior surface on the ends of 1, on the interior of the convex protruding ends of 1) at opposite ends of the drill guide device; wherein the end walls extend across the openings to enclose the protruding boney structure (the end walls extend across or from one side to the other of the openings since each end wall extends across or along the side of one of the openings to form another side of the opening and thus enclose the protruding boney structure); and wherein the window has a size and shape pre-calculated as a function of a size of a pre-determined tool (e.g. drill, screwdriver) to be inserted through the window (col. 10 / lines 39-44; col. 15 / line 65 – col. 16 / line 3).
As to claim 7, Ono discloses the device of claim 1, wherein the body is configured to be slipped over the protruding boney structure, FIGS. 3-4, and snapped into place onto the protruding boney structure (fully capable of snapping into place since the body fits snugly against the boney structure and wraps around it; additionally, due to the undulations of the boney structure against which the body is fit, at least part of the body would snap past and over protruding parts of the boney structure).
As to claim 8, Ono discloses the device of claim 1, wherein: the protruding boney structure comprises at least one of: a spinous process, FIGS. 3-4, a transverse process, an articular process, an inferior articular process, and a superior articular process; and the protruding boney structure is adjacent to at least one boney structure including a vertebra lamina.
As to claim 23, Ono discloses the device of claim 1, wherein the edges of the end walls conform to the protruding boney structure (since the edges of the end walls comprise an edge adjacent to and extending along the reverse-engineering surface approximation, so that the edges also conform to the protruding boney structure along with the surface approximation).
As to claim 24, Ono discloses the device of claim 1, wherein the end walls are substantially planar (at least substantially planar, in a downward direction).
As to claim 25, Ono discloses the device of claim 24, wherein the end walls are substantially parallel to each other, FIG. 1.
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 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 10,085,784 to Ono et al. (hereinafter, “Ono”) in view of U.S. Patent No. US 9,198,678 to Frey et al. (hereinafter, “Frey ‘678”).
As to claim 5, Ono discloses wherein: a boney structure to which the implant is configured to be implanted is adjacent to the protruding boney structure, FIG. 3.
Ono is silent as to the body further comprises: parallel links extending to at least one adjacent boney structure protector, the at least one adjacent boney structure protector includes: an outer surface, an interior surface, body material between the outer surface and the interior surface of the adjacent boney structure protector, and a plurality of holes extending through a thickness of the body material of the adjacent boney structure protector from the outer surface to the interior surface of the adjacent boney structure protector (claim 5); wherein the protruding boney structure comprises boney structures of a plurality of vertebrae (claim 6).
Frey ‘678 teaches a bone-protecting drill guide device for multi-level surgery, where the body comprises a plurality of boney structure protectors coupled to each other by a link (12) (col. 15 / line 66 – col. 16 / line 9), FIG. 8, where each protector includes an outer surface, an interior surface (col. 14 / lines 40-51), body material between the outer surface and the interior surface, and a plurality of holes (16) extending through a thickness of the body material (claim 5); wherein the protruding boney structure comprises boney structures of a plurality of vertebrae (claim 6).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Ono’s device body with at least one adjacent boney structure protector that is coupled by a link to the other boney structure protector, so that each protector can be mounted to and protect a respective vertebra of adjacent vertebrae in a multi-level surgery, as taught by Frey ‘678. Then a multi-level surgery can be completed while ensuring that the adjacent vertebrae remain properly spaced and that implants inserted into them are properly oriented, with the multi-level device also stabilizing the vertebrae relative to each other particularly during insertion of tools through the holes.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide two parallel links connecting the adjacent protectors, since the mere duplication of the essential working parts of a device involves only routine skill in the art and provided two links along a length of the body would provide torsional stability to the device body so that the protectors do not torque relative to each other and lose their proper placement, particularly during insertion of tools through the holes.
Claims 17, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Ono in view of U.S. Patent Application Publication No. US 2020/0360105 to Frey et al. (hereinafter, “Frey ‘105”).
As to claim 17, Ono discloses a method, comprising: providing the surgical bone-protecting drill guide device of claim 1 for the protruding boney structure of the patient (as above); installing the surgical bone-protecting drill guide device on the protruding boney structure of the patient, FIGS. 3-4; mounting a surgical instrument (drill) to the installed surgical bone-protecting drill guide device (Ono, col. 8 / lines 17-18); and drilling a hole for a bone construct (screw) through the one of the plurality of holes (using the surgical instrument mounted through the hole).
As to claim 18, Ono discloses the method of claim 17, further comprising: installing the bone construct in the drilled hole (Ono, col. 8 / lines 20-22).
As to claim 20, Ono discloses the method of claim 17, wherein: the protruding boney structure comprises at least one of: a spinous process, FIGS. 3-4; a transverse process; an articular process; an inferior articular process; and a superior articular process.
Ono is silent as to registering a location of one of the plurality of holes (claim 17); and using a robotic surgical system to install the bone construct (claim 18).
Frey ‘105 teaches a method comprising providing a patient-specific bone-protecting drill guide device (110), FIG. 17, comprising implant guides (118) and a marker (M) that conveys registration and instructions to a robotic device so that it can be located by the robotic device without having to rescan the patient throughout the surgery. The robotic device may view the patient through the marker and align instrumentation controlled by the robotic device (par. [0103], [0108]-[0109]). Frey ‘105 teaches using the robotic device to install a bone construct (screw) through the guide device to provide accurate placement (par. [0105]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to utilize a robotic surgical system as taught by Frey ‘105 in the method of Ono, by providing a marker on the drill guide device that conveys registration and instructions to the robotic system so that the device can be located by the robotic system without having to rescan the patient throughout the surgery. Since the device is patient-specific and is positioned on the bone in one precise position using the interior surface, locating the device also locates the precise location on the bone to which the device is attached. The robotic system may view the patient through the marker and align instrumentation controlled by the robotic system, including the instrumentation that installs the screws through the holes, to ensure accurate placement of the screws based on the registered location of the patient-specific guide device on the bone.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Ono in view of Frey ‘105 (hereinafter, “Ono/Frey ‘105”), as applied to claims 17, 18, and 20 above, and further in view of U.S. Patent No. US 9,198,678 to Frey et al. (hereinafter, “Frey ‘678”).
Ono/Frey ‘105 discloses wherein the surgical bone-protecting drill guide device comprises: a first portion and a second portion (lateral halves of the body), but are silent as to a connector; and the method further comprising: installing the first portion on the protruding boney structure of the patient, and connecting the second portion to the first portion, via the connector.
Frey ‘678 teaches a surgical bone-protecting drill guide device, FIGS. 53B-54C, comprising: a body comprising a first portion (lateral portion of 525 at the implant guide of 525), a second portion (lateral portion of 527 at the implant guide of 527) (col. 30 / lines 32-66), and a connector (adjacent ends of 525/527 where they connect to each other); installing the first portion on the protruding boney structure of the patient, and connecting the second portion to the first portion, via the connector, FIGS. 53B-53D.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to comprise Ono/Frey ‘105’s device body of separate first and second portions (lateral halves) since constructing a formerly integral structure in various elements involves only routine skill in the art, and providing two separate portions that are then locked together about the protruding boney structure would reduce the size of the incision needed and reduce tissue damage and recovery time. Assembling the device about the bone in situ would also allow the device to snugly surround the protruding boney structure without damaging boney protrusions during sliding over the bone. Frey ‘678 contemplates the separate first and second portions that are coupled together and locked rigidly about the bone are applicable to portions having patient-specific surfaces (col. 30 / lines 58-62), and is therefore applicable to Ono/Frey ‘105 which discloses the reverse-engineering surface approximation. As taught by Frey ‘678, the first and second portions would be provided with a connector (adjacent ends with complementary connection parts) that connects them together.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ono in view of U.S. Patent Application Publication No. US 2020/0138592 to Bono et al. (hereinafter, “Bono”).
Ono is silent as to a robotic arm comprising a robotic end effector, and a robotic effector interface extending from the outer surface of the body of the surgical bone-protecting drill guide device, the robotic effector interface configured to connect to the robotic end effector.
Bono teaches a device (101) comprising a body including an outer surface, and a robotic effector interface (168) extending from the outer surface (par. [0033]), FIG. 3, and a robotic arm comprising a robotic end effector (par. [0008]), the robotic effector interface configured to connect to the robotic end effector (par. [0033]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Ono’s device a robotic effector interface extending from the outer surface of the body of the surgical bone-protecting drill guide device, for connection to a robotic end effector of a robotic arm so that the robot comprising the robotic arm and end effector can pick up, hold, and orient the device for insertion into place on the bone, as directed by the computing system which can direct the robot based on the pre-planned implant location data so that the device is accurately installed on the portion of bone to which it is reverse-engineered.
Claims 9, 13-16, and 26-28 are rejected under 35 U.S.C. 103 as being unpatentable over Ono in view of Frey ‘678.
As to claim 9, Ono discloses a method, comprising: receiving, by a computing system, pre-operative image data of at least one bone with a protruding boney structure of a patient (col. 5 / lines 22-25; col. 16 / lines 19-23); receiving, by the computing system, pre-planned implant location data of preplanned implant locations at which implants (screws) are to be implanted relative to the protruding boney structure of the at least one bone (col. 2 / line 66 – col. 3 / line 6; col. 5 / lines 21-36); and generating a body (A) of a three-dimensional bone-protecting drill guide device by: forming an interior surface (inwardly facing surfaces of 1 and 2 facing toward bone) as a reverse-engineering approximation of a surface of the protruding boney structure of the patient (col. 16 / lines 11-27), FIGS. 1-4 and 8, such that edges (in the perspective of FIG. 1, the edges are along and form the ends of 1 adjacent the 2’s, behind the downwardly extending end walls) of the reverse-engineering surface approximation of the interior surface define openings (openings or concavities that are recessed into the interior surface on the ends of 1, on the interior of the convex protruding ends of 1) at opposite ends of the drill guide device; forming an outer surface (outwardly facing surfaces away from bone) at a predetermined distance from the interior surface (col. 16 / lines 23-24); forming end walls (in the perspective of FIG. 1, the walls forming the left and right sides/downwardly extending ends of the cap/hooded portion of 1 that face each other and extend down along 2’s) configured to enclose the protruding boney structure, wherein the end walls extend across the openings at opposite ends of the drill guide device to enclose the protruding boney structure (the end walls extend across or from one side to the other of the openings since each end wall extends across or along the side of one of the openings to form another side of the opening and thus enclose the protruding boney structure); and forming a plurality of holes (cannulation through 2’s) (col. 8 / lines 36-44), extending through a thickness of the body from the outer surface to the interior surface, wherein each of the plurality of holes is configured to provide a window to the pre-planned implant location for implanting a respective one implant (screw) relative to the protruding boney structure of the patient (col. 1 / lines 29-36; col. 16 / lines 24-27), wherein the reverse-engineering approximation of the interior surface is configured to conform to the protruding boney structure along a continuous path from a first hole of the plurality of holes to a second hole of the plurality of holes (since the reverse-engineering surface approximation extends along a continuous path from one 2 to the other 2, shown in FIGS. 1-2); wherein the window has a size and shape pre-calculated as a function of a size of a pre-determined tool (e.g. drill, screwdriver) to be inserted through the window (col. 10 / lines 39-44; col. 15 / line 65 – col. 16 / line 3); and causing a 3D printer to manufacture the three-dimensional bone-protecting drill guide device (col. 2 / line 64 – col. 3 / line 6; col. 7 / lines 21-38; col. 13 / line 33 – col. 14 / line 4).
As to claim 15, Ono discloses the method of claim 9, wherein the body is configured to be slipped over the protruding boney structure of the patient, FIGS. 3-4.
As to claim 16, Ono discloses the method of claim 9, wherein: the protruding boney structure comprises at least one of: a spinous process, FIGS. 3-4, a transverse process, an articular process, an inferior articular process, and a superior articular process.
As to claim 26, Ono discloses the method of claim 9, wherein forming end walls configured to enclose the protruding boney structure comprises forming end walls such that the edges of the end walls conform to the protruding boney structure (since the edges of the end walls comprise an edge adjacent to and extending along the reverse-engineering surface approximation, so that the edges also conform to the protruding boney structure along with the surface approximation).
As to claim 27, Ono discloses the method of claim 9, wherein forming end walls configured to enclose the protruding boney structure comprises forming end walls that are substantially planar (at least substantially planar, in a downward direction).
As to claim 28, Ono discloses the method of claim 27, wherein forming end walls configured to enclose the protruding boney structure comprises forming end walls that are substantially parallel to each other, FIG. 1.
Ono is silent as to generating, by the computing system, a model of the body; and providing the generated model to the 3D printer (claim 9).
Frey ‘678 teaches a method, comprising: receiving, by a computing system, pre-operative image data of at least one bone with a protruding boney structure of a patient (col. 1 / line 54 – col. 2 / line 7, col. 12 / lines 26-27); receiving, by the computing system, pre-planned implant location data of pre-planned implant locations at which implants are to be implanted relative to the protruding boney structure of the at least one bone (col. 12 / lines 30-32, col. 15 / lines 42-51); and generating, by the computing system, a model of a body of a three-dimensional bone-protecting drill guide device (col. 12 / lines 33-35), FIGS. 53B-54C, by: forming an interior surface (cross-hatched surfaces in FIG. 54A) as a reverse-engineering surface approximation of the protruding boney structure of the patient (col. 1 / line 54 – col. 2 / line 7, col. 14 / lines 40-51, col. 30 / line 63 – col. 31 / line 2), forming an outer surface (all surfaces facing away from bone) at a predetermined distance from the interior surface, and forming a plurality of holes (holes at ends of wings), wherein each hole is configured to extend from the outer surface and through the body and the interior surface and provide a window (aperture) to the pre-planned implant location for implanting a respective one implant (pedicle screw) relative to the protruding boney structure of the patient (col. 15 / line 66 – col. 16 / line 9), and wherein the window has a size and shape pre-calculated as a function of a size of a pre-determined tool to be inserted through the window (col. 16 / lines 30-50), FIG. 10; and providing the generated model to a 3D printer (e.g. powder bed printing machine, selective laser sintering machine), causing the 3D printer to manufacture the three-dimensional bone-protecting drill guide device (col. 5 / lines 11-15, col. 6 / lines 27-37, col. 12 / lines 33-39, col. 13 / lines 26-40 and 50-54).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include in Ono’s method the step of generating, by the computing system, a model of the body of the three-dimensional bone-protecting drill guide device before manufacturing the device as taught by Frey ‘678, in order to pre-operatively assess the fit of the body against the boney structure, also avoiding delicate structures, so that any necessary changes can be made before manufacture and before the surgery is begun, thereby reducing surgical time and cost. Since Ono also requires a patient-specific interior surface that precisely fits the boney structure, a model of the body can ensure that the fit is achieved to a tight tolerance. Once confirmed, the generated model is provided to the 3D printer so that the device can be manufactured by precisely reproducing the image data used to create the model to ensure the manufactured device accurately fits the boney structure as modeled.
As to claim 13, Ono discloses wherein: the pre-operative image data of the at least one bone further comprises at least one boney structure adjacent to the protruding boney structure (where the adjacent structure may be a lamina that would be visible in the image data).
Ono is silent as to the generating, by the computing system, the model of the body of the three-dimensional bone-protecting drill guide device, further comprises modeling by: forming at least one adjacent boney structure protector, the at least one adjacent boney structure protector being formed by: forming an interior surface, and forming an outer surface; forming a plurality of holes extending from the outer surface of the adjacent boney structure protector to the interior surface of the adjacent boney structure protector (claim 13); wherein the protruding boney structure comprises a boney structure of a plurality of vertebrae (claim 14).
Frey ‘678 teaches a bone-protecting drill guide device for multi-level surgery, where the body comprises a plurality of boney structure protectors coupled to each other by a link (12) (col. 15 / line 66 – col. 16 / line 9), FIG. 8, where each protector includes an outer surface, an interior surface (col. 14 / lines 40-51), body material between the outer surface portion and the interior surface portion, and a plurality of holes (16) extending from the outer surface of the adjacent boney structure protector to the interior surface of the adjacent boney structure protector (claim 13); wherein the protruding boney structure comprises a boney structure of a plurality of vertebrae (claim 14).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Ono’s device body with at least one adjacent boney structure protector that is coupled by a link to the other boney structure protector, so that each protector can be mounted to and protect a respective vertebra of adjacent vertebrae in a multi-level surgery, as taught by Frey ‘678. Then a multi-level surgery can be completed while ensuring that the adjacent vertebrae remain properly spaced and that implants inserted into them are properly oriented, with the multi-level device also stabilizing the vertebrae relative to each other particularly during insertion of tools through the holes. In the method, then, the model would also comprise forming the adjacent boney structure protector.
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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