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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 May 2025 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 05 May 2025. As directed by the amendment: claims 1, 3-5, 9, 11-13, and 21 have been amended, and claims 2 and 10 are cancelled. Claims 1, 3-9, and 11-22 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the claim objections listed in the previous action, which are correspondingly withdrawn.
The amendments to the claims are not sufficient to overcome the rejections under 35 U.S.C. 112(b) listed in the previous action, which are repeated below in relevant part, in addition to further rejections under 35 U.S.C. 112(b), resulting from the current amendments.
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 Frey ‘678 (US 9,198,678), Applicant contends that Frey ‘678 discloses cutting guides that do not conform to a protruding boney structure along a substantial path. 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). Frey ‘678 is not relied upon to teach this feature.
Further, Applicant contends that Frey ‘678’s disclosure regarding hinges discloses a patient-specific guide calibration model. Examiner respectfully submits that Frey ‘678 recites that modeling is used to assist in the orientation and placement of patient-matched surfaces, and the model is used to create a guide that is adjustable and reusable, where an example of a surgical guide is one with hinges (col. 31 / line 57 – col. 32 / line 4), i.e. the created guide has hinges. Therefore, the recitation regarding hinges is in reference to the guide itself and not to the model that is used to create the guide.
Applicant further contends that Frey ‘678 discloses hinges in relation to a non-patient-specific device, and does not disclose the patient-specific cutting guides requiring such adjustments, and therefore Frey ‘678 does not contemplate the patient-specific cutting guides needing or having adjustment means such as hinges. Examiner respectfully submits that, when describing the modeling that creates the guide with hinges, Frey ‘678 discloses that modeling assists in the orientation and placement of patient-matched surfaces (col. 31 / lines 62-65). Elsewhere, Frey ‘678 contemplates that an adjustable guide comprising first and second portions that are connected together by screws to join them into a rigid assembly about the bone, can have patient-specific surfaces (col. 30 / lines 58-62). Frey ‘678 therefore does contemplate that patient-specific cutting guides can have adjustability.
Applicant further contends that Frey ‘678 discloses an interference fit or one or more pins/screws to join the first and second sections of FIGS. 53A-E into a rigid assembly, and does not disclose how hinges could be included while achieving the required rigid assembly. Thus, Applicant contends that one would not have been motivated to modify Frey ‘678’s patient-specific cutting guides to include a first portion and a second portion coupled by a hinge member. Examiner respectfully submits that Frey ‘678 discloses a hinged guide that can be locked once the user has finished their adjustments (col. 32 / lines 1-4). As above, Frey ‘678 does contemplate that patient-specific cutting guides can have adjustability, and providing this adjustability with hinges as disclosed by Frey ‘678 would still allow achievement of a rigid assembly since Frey ‘678 also discloses that the hinged guide can be locked into place.
Applicant’s arguments with respect to the rejections of claim 9 under 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.
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 a hinge member (claim 1, shown in FIG. 12A);
the body configured to be snapped into place (claim 7, shown in FIGS. 8 or 9A) in the same embodiment as a hinge member (claim 1, shown in FIG. 12A);
the body comprising end walls configured to enclose the protruding boney structure (claim 21, shown in FIG. 8) in the same embodiment as a hinge member (claim 1, shown in FIG. 12A);
a robotic effector interface (claim 22, FIG. 11B) in the same embodiment as a hinge member (claim 1, shown in FIG. 12A);
first and second body portions connected together by connectors (claim 11, shown in FIGS. 10 or 12A) in the same embodiment as a threaded robotic effector interface (claim 9, shown in FIG. 11B);
forming a hole in each of the first connector and the second connector, the holes adapted to receive a fastener (claim 12, shown in FIG. 12A) in the same embodiment as a threaded robotic effector interface (claim 9, shown in FIG. 11B);
forming at least one adjacent boney structure protector (claim 13, shown in FIG. 9B) in the same embodiment as a threaded robotic effector interface (claim 9, shown in FIG. 11B)
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 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 5-7, 11-14, 21, and 22 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 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 first and second portions coupled by a hinge member, as previously recited in claim 1 and shown in FIG. 12A.
As to claim 7, the specification is silent as to the body configured to be snapped into place (FIGS. 8 or 9A) in the same embodiment as first and second portions coupled by a hinge member, as previously recited in claim 1 and shown in FIG. 12A.
As to claim 11, the specification is silent as to forming a first portion and a second portion of the body that are connected together by first and second connectors (FIGS. 10 or 12A), in the same embodiment as a threaded robotic effector interface, as previously recited in claim 9 and shown in FIG. 11B.
As to claim 12, the specification is silent as to forming a hole in each of the first connector and the second connector, the holes adapted to receive a fastener (FIG. 12A), in the same embodiment as a threaded robotic effector interface, as previously recited in claim 9 and shown in FIG. 11B.
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 a threaded robotic effector interface, as previously recited in claim 9 and shown in FIG. 11B.
As to claim 21, the specification is silent as to the body further comprising end walls configured to enclose the protruding boney structure (FIG. 8) in the same embodiment as first and second portions coupled by a hinge member, as previously recited in claim 1 and shown in FIG. 12A.
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 first and second portions coupled by a hinge member, as previously recited in claim 1 and shown in FIG. 12A.
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 5, 6, 13, 14, and 19 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 claim 5, the limitation “the outer surface of the adjacent boney structure protector” (lines 7-8) lacks proper antecedent basis in the claims. Amendment is suggested to “the outer surface”. Further as to claim 5, the limitations “from the outer surface to the interior surface” (lines 15-16) render the claims indefinite because it is unclear if they refer to the outer surface and the interior surface of the body in claim 1, or to the relevant features of the adjacent boney structure protector in claim 5. For examination purposes, the limitations will be interpreted as referring to the relevant features of the adjacent boney structure protector in claim 5, i.e. “from the outer surface portion to the interior surface portion”.
As to claim 13, the limitations “from the outer surface to the interior surface” (line 15) render the claims indefinite because it is unclear if they refer to the outer surface and the interior surface of the body in claim 9, or to the relevant features of the adjacent boney structure protector in claim 13. For examination purposes, the limitations will be interpreted as referring to the relevant features of the adjacent boney structure protector in claim 13, i.e. “from the outer surface portion to the interior surface portion”.
As to claim 19, the limitations “a first portion” and “a second portion” render the claim indefinite because it is unclear if these refer back to the first portion and the second portion previously recited in claim 1 (claim 19 depends on claim 17 which depends on claim 1 and requires the surgical bone-protecting drill guide device of claim 1), or to different first and second portions. For examination purposes, the limitations will be interpreted in the first instance.
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 1, 3-8, and 21 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 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; 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 the body comprises a first portion and a second portion (lateral halves of the body), 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); 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 21, Ono discloses the device of claim 1, wherein the body further comprises end walls (in the perspective of FIG. 2, the walls forming the left and right sides/downwardly extending ends of the cap/hooded portion of 1) configured to enclose the protruding boney structure, FIGS. 3-4.
Ono is silent as to the first portion and the second portion coupled by a hinge member (claim 1); the first portion and the second portion are separate body members; and further comprising: a first connector coupled to a top side of the first portion, and a second connector coupled to a top side of the second portion (claim 3); wherein the body further comprises holes in the first connector and the second connector; and further comprising: a fastener coupled to the first connector and the second connector via the holes in the first connector and the second connector, the fastener configured to lock the first portion and the second portion about the protruding boney structure (claim 4).
As to claim 1, 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) and a second portion (lateral portion of 527 at the implant guide of 527) (col. 30 / lines 32-66), wherein the first connector and the second connector are configured to connect together, FIGS. 53B-53D.
As to claim 3, Frey ‘678 teaches the first portion and the second portion are separate body members, FIG. 53B; and further comprising: a first connector (portion of 525 where it connects to 527) coupled to a top side of the first portion (the first connector is integrally coupled to a top or superior side of the implant guide of the first portion, FIG. 53D), and a second connector (portion of 527 where it connects to 525) coupled to a top side of the second portion (the second connector is integrally coupled to a top or superior side of the implant guide of the second portion, FIG. 53D).
As to claim 4, Frey ‘678 teaches the device of claim 3, wherein the body further comprises holes in the first connector and the second connector (to receive a pin or screw, col. 30 / lines 53-55); and further comprising: a fastener (pin or screw) coupled to the first connector and the second connector via the holes in the first connector and the second connector, the fastener configured to lock the first portion and the second portion about the protruding boney structure.
Frey ‘678 contemplates that coupling of parts of a guide can be adjustably connected to each other with hinges and then locked into place (col. 31 / line 67 – col. 32 / line 4).
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’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 which discloses the reverse-engineering surface approximation. As taught by Frey ‘678, the first and second portions would be provided with respective connectors. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to couple the first connector and the second connector to a hinge member that allows the connectors and the portions of the body to be adjusted relative to each other for ease of mounting on the boney structure, while preventing their complete disconnection which would make the installation process more difficult. Then, as contemplated by Frey ‘678, the connectors/portions of the body can be locked into place when they have reached their final positions on the boney structure, using the pin or screw disclosed in Frey ‘678 to lock the first connector to the second connector and thus the first portion and the second portion about the protruding boney structure. Combining prior art elements (pin/screw and hinge) according to known methods to yield predictable results is within the ordinary skill in the art.
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 portion of the outer surface of the adjacent boney structure protector, an interior surface portion of the interior surface, the interior surface portion is a reverse-engineering surface approximation of at least one adjacent boney structure of the patient, body material between the outer surface portion and the interior surface portion 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, wherein each of the plurality of holes of the adjacent boney structure protector extends through the outer surface portion of the adjacent boney structure protector and the interior surface portion 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 portion, an interior surface portion that is a reverse-engineering surface approximation of at least one adjacent boney structure of the patient (col. 14 / lines 40-51), body material between the outer surface portion and the interior surface portion, and a plurality of holes (16), wherein each of the holes of the adjacent boney structure protector extends through the outer surface portion of the adjacent boney structure protector and the interior surface portion of the adjacent boney structure protector (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 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ono in view of Frey ‘678 (hereinafter, “Ono/Frey ‘678”), as applied to claims 1, 3-8, and 21 above, and further in view of U.S. Patent Application Publication No. US 2020/0360105 to Frey et al. (hereinafter, “Frey ‘105”).
As to claim 17, Ono/Frey ‘678 disclose a method, comprising: providing the surgical bone-protecting drill guide device of claim 1 for a 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/Frey ‘678 disclose the method of claim 17, further comprising: installing the bone construct in the drilled hole (Ono, col. 8 / lines 20-22).
As to claim 19, Ono/Frey ‘678 disclose the method of claim 17, wherein the surgical bone-protecting drill guide device comprises: a first portion, a second portion, and 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 (see modification in view of Frey ‘678, as described with respect to claims 3 and 4 above; the connector of claim 19 is met by either the first or second connector of Frey ‘678 described with respect to claim 3).
As to claim 20, Ono/Frey ‘678 disclose 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/Frey ‘678 are 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/Frey ‘678, 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 22 is rejected under 35 U.S.C. 103 as being unpatentable over Ono/Frey ‘678 as applied to claims 1, 3-8, and 21 above, and further in view of U.S. Patent Application Publication No. US 2020/0138592 to Bono et al. (hereinafter, “Bono”).
Ono/Frey ‘678 are 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/Frey ‘678’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 and 11-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ono in view of Frey ‘678, Bono, and U.S. Patent Application Publication No. US 2020/0289050 to Moctezuma de la Barrera et al. (hereinafter, “Moctezuma”).
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 the protruding boney structure of the patient (col. 16 / lines 11-27), FIGS. 1-4 and 8, forming an outer surface (outwardly facing surfaces away from bone) at a predetermined distance from the interior surface (col. 16 / lines 23-24); 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.
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.
Ono is silent as to forming a threaded robotic effector interface extending from the outer surface (claim 9).
Bono teaches a device (101) comprising a body including an outer surface, and forming a robotic effector interface (168) extending from the outer surface (par. [0033]), FIG. 3, for connection to a robotic arm so that the robot comprising the robotic arm can pick up, hold, and orient the device for insertion into place on the bone.
Moctezuma teaches that a robotic arm can be secured via various connection means including threaded connectors (par. [0032]).
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, forming a robotic effector interface extending from the outer surface of the body, for connection to a robotic arm so that the robot comprising the robotic arm 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, thereby ensuring robotic accuracy and sterility. In view of Moctezuma, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the connection with the robotic arm as a threaded robotic effector interface extending from the outer surface as part of a threaded connector, since this would provide secure connection without inadvertent disconnection and dropping of the device, and since the simple substitution of one known element for another (replacing a post with a threaded connector) to obtain predictable results (connection) is within the ordinary skill in the art. Alternatively, as taught by Moctezuma, the robotic arm is threadedly connected to an interface tool that engages the robotic effector interface taught by Bono. When connected to the robotic effector interface, this interface tool would be included as part of the robotic effector interface (interfaces with the robotic arm), and since it is threaded, results in a threaded robotic effector interface extending from the outer surface. The step of forming the threaded robotic effector interface extending from the outer surface would be included in the modeling step taught by Frey ‘678 to pre-operatively assess the interconnection of the parts.
As to claims 11 and 12, Ono is silent as to wherein the generating, by the computing system, the model of the body of the three-dimensional bone-protecting drill guide device, further comprises modeling by: determining an apex of the reverse-engineering approximation of the protruding boney structure of the patient; forming a first portion and a second portion of the body along a plane of the protruding boney structure, the first portion and the second portion are separate body members; forming a first connector coupled to a top side of the first portion; and forming a second connector coupled to a top side of the second portion, wherein the first connector and the second connector are configured to connect together (claim 11); wherein 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 a hole in each of the first connector and the second connector, the holes in the first connector and the second connector adapted to receive a fastener to lock the first portion and the second portion about the protruding boney structure (claim 12).
As to claim 11, Frey ‘678 teaches the method of claim 9, wherein the generating, by the computing system, the model of the body of the three-dimensional bone-protecting drill guide device, further comprises modeling by: determining an apex of the reverse-engineering approximation of the protruding boney structure of the patient (since the joint between the body portions is formed at the apex); forming a first portion (525) and a second portion (527) of the body along a plane of the protruding boney structure (col. 30 / lines 32-66), the first portion and the second portion are separate body members, FIG. 53B; forming a first connector (wing or extension of 525) coupled to a top side of the first portion (the top side is the superior end of the hole of the first portion, FIG. 53D); and forming a second connector (wing or extension of 527) coupled to a top side of the second portion (the top side is the superior end of the hole of the second portion, FIG. 53D), wherein the first connector and the second connector are configured to connect together, FIGS. 53B-53D.
As to claim 12, Frey ‘678 teaches the method of claim 11, wherein 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 a hole in each of the first connector and the second connector (to receive a pin or screw, col. 30 / lines 53-55), the holes adapted to receive a fastener (pin or screw) to lock the first portion and the second portion about the protruding boney structure.
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’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 which discloses the reverse-engineering surface approximation. In the method, then, the model would also comprise these first and second portions which are divided at the apex of the reverse-engineering surface approximation so that the portions can be placed on either side of the boney structure. As taught by Frey ‘678, the first and second portions would be provided with respective connectors. Then, as contemplated by Frey ‘678, the connectors/portions of the body can be locked into place when they have reached their final positions on the boney structure, using the pin or screw disclosed in Frey ‘678 to lock the first connector to the second connector and thus the first portion and the second portion about the protruding boney structure.
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 portion of the interior surface, the interior surface portion being a reverse-engineering surface approximation of the at least one adjacent boney structure of the patient, and forming an outer surface portion of the outer surface, the outer surface portion at a distance from the interior surface portion of the adjacent boney structure protector; forming a plurality of holes extending through a thickness of the body from the outer surface to the interior surface of the adjacent boney structure protector; and each of the plurality of holes of the adjacent boney structure protector extends through the outer surface portion of the adjacent boney structure protector and the interior surface portion 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 portion, an interior surface portion that is a reverse-engineering surface approximation of the at least one adjacent boney structure of the patient (col. 14 / lines 40-51), body material between the outer surface portion and the interior surface portion, and a plurality of holes (16), wherein each hole of the adjacent boney structure protector extends through the outer surface portion of the adjacent boney structure protector and the interior surface portion 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
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775