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 claim amendments filed on 22 October 2025. As directed by the amendment: claims 1, 8, and 10 have been amended, claims 11-15 stand withdrawn, claims 6 and 7 are cancelled, and claims 16-20 are newly added. Claims 1-5 and 8-20 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to the claims are sufficient to overcome the claim objections listed in the previous action, which are accordingly withdrawn. However, further claim objections as necessitated by the current amendments are presented below.
Response to Arguments
Applicant’s arguments with respect to the rejections 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.
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). As to Fard (US 2006/0089621), Applicant contends that the first rough and second smooth milling operations are both constrained and guided by the same physical template and not performed up to a first determined distance and a second determined distance from the final cut plane. As to claim 8, Examiner respectfully submits that Fard was relied upon as a teaching of using different burr heads with different cutting geometries to achieve coarse or fine cutting; Maier discloses the second fine bone removal operation removes bone closer to the intended final cut plane, and Otto teaches different/adjustable virtual boundaries.
Claim Objections
Claims 1-5, 8-10, and 16-20 are objected to because of the following informalities: improper antecedence. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 8: “the second plurality of settings includes”
Claim 1 / line 16: “the second determined distance”
Claim 8 / line 17: “the second determined distance”
Claim 17 / line 1: “wherein the adjusting of the first plurality of settings”
Claim 19 / line 3: “the second plurality of settings includes”
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 1-5 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. US 9,974,557 to Maier et al. (hereinafter, “Maier”) in view of U.S. Patent Application Publication No. US 2019/0008525 to Jaramaz et al. (hereinafter, “Jaramaz”), U.S. Patent Application Publication No. US 2006/0089621 to Fard, U.S. Patent Application Publication No. US 2014/0180290 to Otto et al. (hereinafter, “Otto”), and U.S. Patent No. US 9,707,043 to Bozung.
As to claim 1, Maier discloses a method of preparing a bone for a joint implant, the method comprising: performing a first bone removal operation (initial free-form milling into the bone surface, col. 8 / lines 62-65) using a device with a first plurality of settings (manual settings, including higher removal rate based on rotation speed and blade exposure, col. 5 / line 58 – col. 6 / line 20, col. 8 / line 60 – col. 9 / line 14); based on a distance between a current bone surface and an intended final cut plane (work space boundary, col. 9 / lines 10-14), adjusting the first plurality of settings to a second plurality of settings (reduced removal rate based on slightly reduced rotation speed and reduced blade exposure, col. 5 / line 58 – col. 6 / line 20, col. 8 / line 60 – col. 9 / line 14); and performing a second bone removal operation (removal of bone closer to the work space boundary to achieve a high surface finish, using the reduced removal rate) using the device with the second plurality of settings; wherein the intended final cut plane comprises a facet of the joint implant, wherein the first bone removal operation comprises bulk removal of bone (larger volume of bone removed by the greater removal rate) up to a first determined distance (determined at least upon completion) from the intended final cut plane; wherein the second bone removal operation comprises fine removal of bone (finer more exact removal of bone accomplished with the reduced removal rate) up to a second determined distance (determined at least upon completion) from the intended final cut plane; wherein the second determined difference is less than the first determined distance (since the second bone removal operation removes bone closer to the work space boundary/intended final cut plane to achieve a high surface finish); wherein the bulk removal of bone removes bone more rapidly than the fine removal of bone (reduced removal rate in the second bone removal operation).
As to claim 2, Maier discloses the method of claim 1, wherein the first plurality of settings includes a first rotational velocity and the second plurality of settings includes a second rotational velocity (the second rotational speed is slightly reduced, col. 5 / lines 66-67, as is therefore the second rotational velocity which can be calculated from the speed), wherein the first rotational velocity differs from the second rotational velocity.
As to claim 3, Maier discloses the method of claim 1, wherein the first plurality of settings includes a first exposure and the second plurality of settings includes a second exposure (as adjusted by the position of cutting edges or a cutting edge cover, the second exposure for the reduced removal rate being less than the first exposure, col. 8 / line 67 – col. 9 / line 3), wherein the first exposure differs from the second exposure.
As to claim 4, Maier discloses the method of claim 1, wherein the first plurality of settings includes a first torque value and the second plurality of settings includes a second torque value (since the second plurality of settings includes a slightly reduced rotation speed and torque can be calculated from rotation speed, the second torque value will also be slightly different compared to the first), wherein the first torque value differs from the second torque value.
As to claim 17, Maier discloses the method of claim 1, wherein adjusting the first plurality of settings to the second plurality of settings is controlled by a computer aided surgical system (col. 7 / lines 1-22).
Maier is silent as to the joint implant having a plurality of facets, wherein the intended final cut plane comprises a plurality of planes, each plane corresponding to a facet of the plurality of facets of the joint implant.
Jaramaz teaches a knee joint implant has a plurality of facets (110A-110D), FIG. 1, wherein an intended final cut plane on the bone comprises a plurality of planes, each plane corresponding to a facet of the joint implant (par. [0041]).
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 Maier’s method to prepare a bone for a knee joint implant having a plurality of facets, wherein the intended final cut plane comprises a plurality of planes, each plane corresponding to a facet of the joint implant, since Maier contemplates performing bone removal operations to prepare the bone for a knee implant (Maier, col. 8 / lines 62-64) but does not specify the type of implant, and Jaramaz teaches that a knee joint implant having a plurality of facets is typical for a knee replacement surgery, and using such an implant would have been “obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Then, for the underlying bone to be complementarily shaped to fit the faceted knee joint implant as taught by Jaramaz, the intended final cut plane would comprise a plurality of planes, each plane corresponding to a facet of the joint implant, as also taught by Jaramaz, so that the implant fits securely on the bone.
Maier is silent as to the device being a burring device.
Fard teaches that preparing a bone to receive a knee replacement implant can be performed by a burring device that removes bone (par. [0038]).
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 burring device for Maier’s bone removal operations, since Fard teaches that a burring device is appropriate for preparing a bone to receive a knee replacement implant and it would have been “obvious to try” – choosing from a finite number of identified, predictable solutions (type of device, e.g. burr or drill), with a reasonable expectation of success (bone removal).
Maier is silent as to wherein the first plurality of settings includes a first virtual boundary; wherein the second plurality of settings include a second virtual boundary, the second virtual boundary being different from the first virtual boundary.
Otto teaches that a haptic object that maintains a cutting device within a desired planned area can be adjustable as new information is gathered during the surgical procedure to allow real-time updating of the surgical plan (par. [0057]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to control the burring device of Maier using haptic boundaries that provide feedback to the operator, therefore guiding or limiting movement of the burring device and preventing inadvertent movement of the burring device outside of the desired cutting area, as taught by Otto. As applied to Maier, the first plurality of settings which controls the first bulk bone removal operation would include a first virtual or haptic boundary as taught by Otto to ensure that the burring device under the first plurality of settings remains a distance away from the intended final cut plane so that the coarse/higher removal rate first cutting operation is maintained a distance away from the intended final cut plane which requires more precision. Then, when the distance between the current bone surface and the intended final cut plane is achieved and the settings are adjusted to the second plurality of settings for more precise/fine/lower removal rate cutting, the haptic boundary can be adjusted based on this information gathered during the surgical procedure as taught by Otto, such as the amount of bone already resected and the amount of bone left to be resected, to provide a second virtual or haptic boundary that allows the burring device under the second plurality of settings to achieve the final cuts of the intended final cut plane.
Maier is silent as to wherein outside of the first virtual boundary, the burring device is retracted or inactivated during the first bone removal operation, and wherein outside of the second virtual boundary, the burring device is retracted or inactivated during the second bone removal operation.
Bozung teaches a method of preparing a bone, the method comprising performing a bone removal operation using a device within a virtual boundary (col. 3 / lines 1-21), where a navigation system determines a position of the device relative to the virtual boundary to maintain a desired relationship to the virtual boundary during cutting to remove a defined volume of bone. If the device strays outside of the virtual boundary, the device is stopped (col. 2 / lines 3-12) to prevent cutting of bone outside of the defined volume which would lead to damage and undesirable bone loss.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to stop or inactivate Maier’s burring device during each bone removal operation if the device strays outside of the respective virtual boundary, to prevent cutting of bone outside of the desired volume to be removed, which would result in bone damage and undesirable bone loss. Accordingly, outside of the first virtual boundary, the burring device would be inactivated during the first bone removal operation, and outside of the second virtual boundary, the burring device would be inactivated during the second bone removal operation.
As to claim 5, Maier is silent as to wherein the first plurality of settings includes a first burr head having a first cutting geometry and the second plurality of settings includes a second burr head having a second cutting geometry, wherein the first cutting geometry differs from the second cutting geometry.
Fard teaches performing a first bone removal operation using a first burr head having a first cutting geometry (coarse, par. [0046]) and, once closer to the intended final cut plane, performing a second bone removal operation using a second burr head having a second cutting geometry (fine), wherein the first cutting geometry differs from the second cutting geometry, to smooth the surface and sides of the cavity formed in the bone.
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 coarse first burr head with a coarse first cutting geometry to quickly remove most of the bone, followed by using a fine second burr head having a fine second cutting geometry to smooth the surface and sides of the cavity (the planes corresponding to the facets as modified above) formed in the bone once the cutting has approached the intended final cut plane. This would save time as compared to using only a fine burr, which would not remove the bulk of the bone very quickly, while also maintaining the precision required at the intended final cut plane in order to properly fit the implant facets, which could not be achieved by using only a coarse burr.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Maier in view of Jaramaz, Fard, Otto, and Bozung (hereinafter, “Maier/Jaramaz/Fard/Otto/Bozung”), as applied to claims 1-5 and 17 above, and further in view of U.S. Patent Application Publication No. US 2014/0188240 to Lang et al. (hereinafter, “Lang”).
Maier/Jaramaz/Fard/Otto/Bozung are silent as to the joint implant being cementless.
Lang teaches that an orthopedic fixation type can be cementless (Table 1).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to prepare the bone for a cementless joint implant since Lang teaches that cementless fixation is utilized in orthopedic applications and it would have been “obvious to try” – choosing from a finite number of identified, predictable solutions (cement or cementless), with a reasonable expectation of success (fixation).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Maier in view of Jaramaz, Fard, and U.S. Patent Application Publication No. US 2012/0059378 to Farrell.
As to claim 8, Maier discloses a method of preparing a bone for a joint implant, the method comprising: performing a first bone removal operation (initial free-form milling into the bone surface, col. 8 / lines 62-65) using a first plurality of settings (manual settings, including higher removal rate based on rotation speed and blade exposure, col. 5 / line 58 – col. 6 / line 20, col. 8 / line 60 – col. 9 / line 14) that includes a device; based on a distance between a current bone surface and an intended final cut plane (work space boundary, col. 9 / lines 10-14), performing a second bone removal operation (removal of bone closer to the work space boundary to achieve a high surface finish, using a reduced removal rate) using a second plurality of settings (reduced removal rate based on slightly reduced rotation speed and reduced blade exposure, col. 5 / line 58 – col. 6 / line 20, col. 8 / line 60 – col. 9 / line 14) wherein the intended final cut plane comprises a facet of the joint implant; wherein the first bone removal operation comprises bulk removal of bone (larger volume of bone removed by the greater removal rate) up to a first determined distance (determined at least upon completion) from the intended final cut plane; wherein the second bone removal operation comprises fine removal of bone (finer more exact removal of bone accomplished with the reduced removal rate) up to a second determined distance (determined at least upon completion) from the intended final cut plane; wherein the second determined difference is less than the first determined distance (since the second bone removal operation removes bone closer to the work space boundary/intended final cut plane to achieve a high surface finish); and wherein the bulk removal of bone removes bone more rapidly than the fine removal of bone (reduced removal rate in the second bone removal operation).
Maier is silent as to the joint implant having a plurality of facets, wherein the intended final cut plane comprises a plurality of planes, each plane corresponding to a facet of the joint implant.
Jaramaz teaches a knee joint implant has a plurality of facets (110A-110D), FIG. 1, wherein an intended final cut plane on the bone comprises a plurality of planes, each plane corresponding to a facet of the plurality of facets of the joint implant (par. [0041]).
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 Maier’s method to prepare a bone for a knee joint implant having a plurality of facets, wherein the intended final cut plane comprises a plurality of planes, each plane corresponding to a facet of the joint implant, since Maier contemplates performing bone removal operations to prepare the bone for a knee implant (Maier, col. 8 / lines 62-64) but does not specify the type of implant, and Jaramaz teaches that a knee joint implant having a plurality of facets is typical for a knee replacement surgery, and using such an implant would have been “obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success. Then, for the underlying bone to be complementarily shaped to fit the faceted knee joint implant as taught by Jaramaz, the intended final cut plane would comprise a plurality of planes, each plane corresponding to a facet of the joint implant, as also taught by Jaramaz, so that the implant fits securely on the bone.
Maier is silent as to the device being a burring device.
Fard teaches that preparing a bone to receive a knee replacement implant can be performed by a burring device that removes bone (par. [0038]).
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 burring device for Maier’s bone removal operations, since Fard teaches that a burring device is appropriate for preparing a bone to receive a knee replacement implant and it would have been “obvious to try” – choosing from a finite number of identified, predictable solutions (type of device, e.g. burr or drill), with a reasonable expectation of success (bone removal).
Maier is silent as to the burring device comprising a first burr head having a first cutting geometry; a second burr head having a second cutting geometry different from the first cutting geometry; and performing a second bone removal operation using the second burr head (claim 8); wherein the first cutting geometry is coarse, and wherein the second cutting geometry is fine (claim 9).
Fard teaches performing a first bone removal operation using a first burr head having a first cutting geometry (coarse, par. [0046]) and, once closer to the intended final cut plane, performing a second bone removal operation using a second burr head having a second cutting geometry (fine) different from the first cutting geometry, to smooth the surface and sides of the cavity formed in the bone.
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 coarse first burr head with a coarse first cutting geometry to quickly remove most of the bone, followed by using a fine second burr head having a fine second cutting geometry to smooth the surface and sides of the cavity (the planes corresponding to the facets as modified above) formed in the bone once the cutting has approached the intended final cut plane. This would save time as compared to using only a fine burr, which would not remove the bulk of the bone very quickly, while also maintaining the precision required at the intended final cut plane in order to properly fit the implant facets, which could not be achieved by using only a coarse burr.
Maier is silent as to removing the first burr head from the burring device; affixing to the burring device the second burr head.
Farrell teaches preparing a bone using a burring device with different burr heads of varying size, shape, and surface abrasiveness to achieve coarse bone removal early in the resection procedure and precise resection closer to the final cut plane (par. [0017]), with a burr holder for holding the particular burr head during use (par. [0046]), FIG. 2.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to attach a first burr head to the burring device, the first burr head having the coarse cutting geometry as taught by both Fard and Farrell, to perform the first coarse bone removal operation, and to then remove the first burr head from the burring device and affix the second burr head to the burring device, the second burr head having the fine cutting geometry for more precise finishing as also taught by both Fard and Farrell, since it is well known in the art to have removable burr heads attached to a handle, so that the same handle can be used throughout the procedure, therefore reducing costs associated with multiple handles (and the internal power structures that may reside therein) and/or reducing surgical time by allowing the handle to remain coupled to a robot for maneuvering the burring device handle therefore maintaining the established position of the burring device handle relative to the robot and the bone within the surgical field. Even though the handle would not be replaced for each bone removal operation, the ability to attach and remove different burr heads with different characteristics such as coarse and fine would allow the practitioner to achieve different modes of cutting (coarse bulk cutting and fine finishing cutting) using the same handle.
As to claim 10, Maier/Jaramaz/Fard/Farrell are silent as to wherein the distance between the current bone surface and the intended final cut plane ranges from about 1mm to about 5mm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to make the distance between the current bone surface and the intended final cut plan from about 1mm to about 5mm, since where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Since the second burr head with fine geometry would be used close to the intended final cut plane in order to make finishing smooth cuts, it would have been obvious to make the distance within a small range such as claimed, to save time with the coarse first burr head cutting away the bulk of the bone while also preserving the precision of the final intended cuts once the second burr head is attached and utilized.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Maier in view of Jaramaz, Fard, and Farrell (hereinafter, “Maier/Jaramaz/Fard/Farrell”), as applied to claims 8-10 above, and further in view of Lang.
Maier/Jaramaz/Fard/Farrell are silent as to the joint implant being cementless.
Lang teaches that an orthopedic fixation type can be cementless (Table 1).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to prepare the bone for a cementless joint implant since Lang teaches that cementless fixation is utilized in orthopedic applications and it would have been “obvious to try” – choosing from a finite number of identified, predictable solutions (cement or cementless), with a reasonable expectation of success (fixation).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Maier/Jaramaz/Fard/Farrell, as applied to claims 8-10 above, and further in view of Otto.
Maier/Jaramaz/Fard/Farrell are silent as to wherein the first plurality of settings includes a first virtual boundary wherein the second plurality of settings include a second virtual boundary, the second virtual boundary being different from the first virtual boundary wherein at least one of the first virtual boundary or the second virtual boundary are determined by a computer aided surgical system.
Otto teaches that a haptic object that maintains a cutting device within a desired planned area can be adjustable by a computer aided surgical system as new information is gathered during the surgical procedure to allow real-time updating of the surgical plan (par. [0057]).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to control the burring device of Maier/Jaramaz/Fard/Farrell using haptic boundaries that provide feedback to the operator, therefore guiding or limiting movement of the burring device and preventing inadvertent movement of the burring device outside of the desired cutting area, as taught by Otto. As applied to Maier/Jaramaz/Fard/Farrell, the first plurality of settings which controls the first bulk bone removal operation would include a first virtual or haptic boundary as taught by Otto to ensure that the burring device under the first plurality of settings remains a distance away from the intended final cut plane so that the coarse/higher removal rate first cutting operation is maintained a distance away from the intended final cut plane which requires more precision. Then, when the distance between the current bone surface and the intended final cut plane is achieved and the settings are adjusted to the second plurality of settings for more precise/fine/lower removal rate cutting, the haptic boundary can be adjusted based on this information gathered during the surgical procedure as taught by Otto, such as the amount of bone already resected and the amount of bone left to be resected, to provide a second virtual or haptic boundary that allows the burring device under the second plurality of settings to achieve the final cuts of the intended final cut plane. The virtual boundaries are determined and adjusted by a computer aided surgical system as taught by Otto based on this information gathered during the surgical procedure.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Maier/Jaramaz/Fard/Farrell in view of Otto (hereinafter, “Maier/Jaramaz/Fard/Farrell/Otto”), as applied to claim 19 above, and further in view of Bozung.
Maier/Jaramaz/Fard/Farrell/Otto are silent as to wherein outside of the first virtual boundary, the burring device is retracted or inactivated during the first bone removal operation, or wherein outside of the second virtual boundary, the burring device is retracted or inactivated during the second bone removal operation.
Bozung teaches a method of preparing a bone, the method comprising performing a bone removal operation using a device within a virtual boundary (col. 3 / lines 1-21), where a navigation system determines a position of the device relative to the virtual boundary to maintain a desired relationship to the virtual boundary during cutting to remove a defined volume of bone. If the device strays outside of the virtual boundary, the device is stopped (col. 2 / lines 3-12) to prevent cutting of bone outside of the defined volume which would lead to damage and undesirable bone loss.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to stop or inactivate Maier’s burring device during each bone removal operation if the device strays outside of the respective virtual boundary, to prevent cutting of bone outside of the desired volume to be removed, which would result in bone damage and undesirable bone loss. Accordingly, outside of the first virtual boundary, the burring device would be inactivated during the first bone removal operation, and outside of the second virtual boundary, the burring device would be inactivated during the second bone removal operation.
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