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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 07 April 2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 07 April 2026. As directed by the amendment: claims 1, 8, 12, 17, and 19 have been amended. Claims 1-20 currently stand pending in the application.
The amendments to the claims are sufficient to overcome the previous rejections under 35 U.S.C. 112(a), which are accordingly withdrawn.
Response to Arguments
Applicant's arguments filed 07 April 2026, as to the rejections under 35 U.S.C. 102 and 103 have been fully considered but they are not persuasive. Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
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). Any deficiencies in Matsubara (JP-5412334) are resolved by modification in view of Wilson (US 5,919,195).
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 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by U.S. Patent No. US 8,961,521 to Keefer et al. (hereinafter, “Keefer”).
As to claim 19, Keefer discloses a kit for an acetabular wedge augment reaming tool, comprising: a scoop assembly including a scoop (276) configured to be received within an acetabulum, FIG. 51, the scoop having a diameter corresponding to a diameter of an acetabular cup implant (interpreted as language of intended use; the scoop is fully capable of having a diameter corresponding to a diameter of an acetabular cup implant which can take the place of the scoop in the bone); an acetabular reamer assembly having a reamer head (258), the reamer head having a diameter corresponding to a diameter of an acetabular augment (interpreted as language of intended use; the reamer head is fully capable of having a diameter corresponding to a diameter of an acetabular augment which can be implanted after reaming); a tool guide comprising a reamer guide housing (274) having an enclosure (forming interior of 274; where an enclosure may be partially enclosed)
defined by opposing sidewalls (opposing walls of 584) and opposing end walls (opposing upper portions of sidewalls of 274 with generally parallel edges, FIG. 50, that form the proximal end of the housing) of the reamer guide housing, the opposing end walls separating the opposing sidewalls (the end walls separate the sidewalls from the surface 262), FIG. 50,
and a reamer guide (578) configured to be positioned within the enclosure of the reamer guide housing (col. 24 / lines 4-15), FIG. 52; and a plurality of shims (550, 578, where the shim includes the reamer guide; in addition or alternatively, the shim can include one 550/578 of one shim used at the same time as another shim, where the another shim comprises the reamer guide; col. 24 / lines 28-32), each shim being configured to be positioned within the enclosure of the reamer guide housing, FIG. 52, and each shim being configured to limit movement of the reamer guide within the reamer guide housing (the shim limits movement of the reamer guide to only within the reamer guide housing), wherein the scoop assembly and the acetabular reamer assembly are adapted for operative connection to the tool guide (integrally or as parts of the operative whole) along with a first shim of the plurality of shims such that the first shim is disposed between the scoop assembly and the acetabular reamer assembly, FIG. 52.
As to claim 20, Keefer discloses the kit of claim 19, wherein the reamer guide is slidable within the reamer guide housing such that a second shim of the plurality of shims having a different size than the first shim is disposable between the scoop assembly and the acetabular reamer assembly (where a different shim of the numerous different thicknesses is chosen and comprises the reamer guide, or the reamer guide of the first shim is slid out of the reamer guide housing to allow the second shim to be inserted between the scoop assembly and the acetabular reamer assembly; col. 24 / lines 28-32).
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, 4, 6-8, 10, 14, 17, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over JP-5412334 to Matsubara (see previously provided Machine Translation, “MT”) in view of U.S. Patent No. 5,919,195 to Wilson et al. (hereinafter, “Wilson”).
As to claim 1, Matsubara discloses an acetabular wedge augment reaming tool (interpreted as language of intended use), comprising: a scoop assembly having a scoop (20; due to its concave end), FIG. 7, configured to be received within an acetabulum (interpreted as language of intended use; the scoop is fully capable of being received within an acetabulum since its smaller relative size means that it can be tilted into/at least partially fit in the acetabulum) and a scoop shaft (41) extending from the scoop, FIG. 7; an acetabular reamer assembly having a reamer head (52) and a reamer shaft (shaft portion connected to reamer head 52) extending from the reamer head, FIG. 7; and a tool guide comprising a reamer guide housing (55) including sidewalls (55A, 55B) that at least partially define a cavity (space between 55A and 55B), and a reamer guide (enlarged portion of reamer shaft disposed between 55A and 55B) positioned within the cavity of the reamer guide housing and moveable along a first axis (in direction along 55A/55B) relative to the reamer guide housing (“MT,” par. [0052]), wherein, the scoop shaft of the scoop assembly is connected to the reamer guide housing (par. [0053]), wherein, moving the reamer guide along the first axis moves the reamer assembly closer to or further away from the scoop assembly (par. [0052]).
As to claim 3, Matsubara discloses the acetabular wedge augment reaming tool of claim 1, wherein the scoop further includes a semi-spherical exterior that defines an outer diameter and a semi-spherical cavity that defines an inner diameter, FIG. 7.
As to claim 4, Matsubara discloses the acetabular wedge augment reaming tool of claim 1, wherein the scoop includes a rim (edge of curved part of 20) defining a perimeter (perimeter at straight sides) of the scoop that is interrupted by a cutout (cutout that results in the curved part of 20 not being a full circle) and the scoop shaft is modularly connected to a first side (on the right in FIG. 7) of the scoop and the cutout is positioned at a second side (on the left in FIG. 7) of the scoop opposite the first side.
As to claim 6, Matsubara discloses the acetabular wedge augment reaming tool of claim 1, further comprising a handle assembly having a handle (56) and a handle shaft (smaller diameter portion between 56 and 51) connected to the reamer guide housing (via the reamer guide), wherein the handle assembly extends proximally from the reamer guide housing at an angled offset, FIGS. 7-8.
As to claim 7, Matsubara discloses the acetabular wedge augment reaming tool of claim 1, wherein the reamer shaft includes a mechanical stop (enlarged portion of the shaft distal to 55A,55B) positioned along a length thereof and configured to limit sliding movement thereof (at least proximally).
As to claim 8, Matsubara discloses the acetabular wedge augment reaming tool of claim 1, wherein the reamer guide is further configured to engage the sidewalls from within the cavity of the reamer guide housing (par. [0052]), FIG. 7.
As to claim 10, Matsubara discloses the acetabular wedge augment reaming tool of claim 1, wherein the scoop has a convex exterior (on the right in FIG. 7) having a first diameter configured to correspond to a reamed diameter of the acetabulum (interpreted as language of intended use; a diameter of the convex exterior is fully capable of corresponding to a reamed diameter of an acetabulum since the term correspond means to be in agreement or similar to, and the diameter of the convex exterior can be in agreement/complementary or similar to a reamed diameter of any acetabulum of the same size, or the diameter of the convex exterior corresponds to/is similar to/is the same as a diameter of a portion of the acetabulum).
As to claim 14, Matsubara discloses the acetabular wedge augment reaming tool of claim 1, wherein the reamer head is spherical, FIG. 7, or planar.
Matsubara is silent as to the cavity having a fully enclosed perimeter, the reamer shaft of the acetabular reamer assembly is slidably connected to the reamer guide such that it is moveable along a second axis relative to the reamer guide, and wherein the first axis is different than the second axis (claim 1); the mechanical stop configured to limit sliding movement relative to the reamer guide (claim 7).
Wilson teaches a scoop assembly having a scoop (113) configured to be received within an acetabulum, FIG. 4A, and a scoop shaft (108) extending from the scoop; an acetabular reamer assembly having a reamer head (106) and a reamer shaft (104) extending from the reamer head; and a tool guide comprising a reamer guide housing (110) and a reamer guide (132), wherein, the reamer shaft of the acetabular reamer assembly is slidably connected to the reamer guide such that it is moveable along a second axis (of the reamer shaft) relative to the reamer guide (col. 5 / lines 51-57, col. 8 / lines 53-56), FIGS. 4A-4B, and the scoop shaft of the scoop assembly is connected to the reamer guide housing. Wilson teaches the reamer shaft includes a mechanical stop (144) positioned along a length thereof and configured to limit sliding movement thereof (at least distally) relative to the reamer guide (col. 8 / lines 58-60).
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Matsubara such that the reamer shaft is slidably connected to the reamer guide as taught by Wilson in order for the reamer head to move distally into contact with the bone, as required by both Matsubara and Wilson, instead of the reamer guide housing moving distally relative to the scoop shaft, by attaching the reamer guide housing to the scoop shaft and separating the reamer shaft from the reamer guide such that the reamer shaft is slidable within the reamer guide, since separating the reamer shaft from the reamer guide comprises constructing a formerly integral structure in various elements which involves only routine skill in the art, and causing the reamer shaft to slide instead of the reamer guide housing is a reversal of function of the essential working parts of a device which involves only routine skill in the art, and since Wilson teaches that distal movement of the reamer shaft can be used to advance the reamer head into a reaming position against the bone. The reamer guide would still slide along the first axis relative to the reamer guide housing as required by Matsubara. The first axis along 55A/55B is different than the second axis of the reamer shaft. It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include a mechanical stop on the reamer shaft proximal to the reamer guide to limit sliding of the reamer shaft therein in a distal direction, in order to form a cavity with a precise depth and to prevent the reamer shaft and reamer head from being pushed too far distally and over-reaming the bone.
It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to enclose the cavity in the housing on all four sides to have a fully enclosed perimeter, to prevent the reamer guide from fully sliding out of the cavity. As taught by Wilson, the reaming assembly may be assembled so as to be positioned through a circumferentially enclosed reamer guide, while allowing sliding of the reamer shaft along the second axis, and similarly the reamer guide can be assembled so as to be positioned through a circumferentially enclosed housing in Matsubara, while allowing sliding of the reamer guide toward and away from the indexing assembly along the first axis within the fully enclosed cavity.
As to claim 17, Matsubara discloses a reaming tool, FIG. 7, comprising: a guide assembly having a housing (55) and a reamer guide (enlarged portion of reamer shaft disposed between 55A and 55B), the housing having a first end (at 55C), a second end (at open end), and a channel (space between 55A and 55B) located between the first and second ends, the channel being enclosed by the first end, the second end (since the channel is negative space defined by the limits of the housing, which ends at the second end/ends of 55A,B and thus the channel also ends at the second end/ends of 55A,B), and opposing sidewalls (55A, 55B), a first axis (in direction along and between 55A/55B) passing through the first end and the second end, the reamer guide being disposed within the channel and moveable therein along the first axis (in direction along 55A/55B) (par. [0052]); a reaming assembly having a reamer head (52) and a reamer shaft (shaft portion connected to reamer head 52) extending from the reamer head, an elongate dimension of the reamer shaft extending along a second axis (axis of the reamer shaft) and being coupled to the reamer guide (at least integrally); and an indexing assembly having an indexing head (20) configured to be received within a bone void (interpreted as language of intended use; fully capable of being received within a bone void such as the void adjacent the acetabular rim) and an indexing shaft (41) extending from the indexing head, an elongate dimension of the indexing shaft extending along a third axis (axis of 41) and being coupled to the housing (par. [0054]), wherein moving the reamer guide along the first axis from a first position to a second position (toward or away from 55C) moves the reaming assembly relative to the indexing assembly, and wherein the second and third axes are parallel in the first and second positions, FIGS. 7-8.
As to claim 18, Matsubara discloses the reaming tool of claim 17, wherein the first axis is perpendicular to the second and third axes, FIGS. 7-8.
Assuming arguendo, Matsubara is silent as to the channel being enclosed by the first end, the second end, and opposing sidewalls.
Wilson teaches a guide assembly, FIG. 4A, having a housing (110) and a reamer guide (132); a reaming assembly having a reamer head (106) and a reamer shaft (104) extending from the reamer head, an elongate dimension of the reamer shaft extending along a second axis and being coupled to the reamer guide (col. 5 / lines 51-57, col. 8 / lines 53-56), FIGS. 4A-4B; and an indexing assembly having an indexing head (113) configured to be received within a bone void and an indexing shaft (108) extending from the indexing head, an elongate dimension of the indexing shaft extending along a third axis and being coupled to the housing.
Accordingly, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Matsubara such that the reamer shaft is slidably connected to the reamer guide as taught by Wilson in order for the reamer head to move distally into contact with the bone, as required by both Matsubara and Wilson, instead of the reamer guide housing moving distally relative to the scoop shaft, by attaching the reamer guide housing to the scoop shaft and separating the reamer shaft from the reamer guide such that the reamer shaft is slidable within the reamer guide, since separating the reamer shaft from the reamer guide comprises constructing a formerly integral structure in various elements which involves only routine skill in the art, and causing the reamer shaft to slide instead of the reamer guide housing is a reversal of function of the essential working parts of a device which involves only routine skill in the art, and since Wilson teaches that distal movement of the reamer shaft can be used to advance the reamer head into a reaming position against the bone. The reamer guide would still slide along the first axis relative to the reamer guide housing as required by Matsubara. It also would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to enclose the channel in the housing on all four sides, by providing a housing end opposite the first end, to prevent the reamer guide from fully sliding out of the channel. As taught by Wilson, the reaming assembly may be assembled so as to be positioned through a circumferentially enclosed reamer guide, while allowing sliding of the reamer shaft along the second axis, and similarly the reamer guide can be assembled so as to be positioned through a circumferentially enclosed housing in Matsubara, while allowing sliding of the reamer guide toward and away from the indexing assembly along the first axis within the enclosed channel. Then, the channel would be enclosed by the first end (at 55C), a second end of the housing provided by a wall opposite 55C, and the sidewalls (55A, 55B). The first axis, which extends in a direction along and between the sidewalls (55A, 55B), would then pass through the first end and the second end of the housing on the ends of the channel.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over JP-5412334 to Matsubara in view of Wilson (hereinafter, “Matsubara/Wilson”), as applied to claims 1, 3, 4, 6-8, 10, 14, 17, and 18 above, and further in view of U.S. Patent No. 2,697,433 to Zehnder.
Matsubara/Wilson are silent as to wherein a locking pin is configured on a first side of the reamer guide housing and prevents the reamer guide from falling out of the cavity (claim 12); wherein a reamer guide knob is positioned on a second side of the reamer guide housing and is moveable from a first position in which the reamer guide is moveable relative to the reamer guide housing to a second position in which the reamer guide knob locks the reamer guide in a desired reaming position (claim 13).
Zehnder teaches a guide housing (55) and a guide (44) that is movable relative to the guide housing; wherein a locking pin (70; a pin because it pins the guide in place) is configured on a first side of the guide housing, FIG. 2, and locks the guide in a desired position (col. 3 / lines 17-28); wherein a guide knob (69) is positioned on a second side of the guide housing and is moveable from a first position in which the guide is moveable relative to the guide housing to a second position (tightened) in which the guide knob locks the guide in a desired position.
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 Matsubara/Wilson a locking pin above the reamer guide housing and a guide knob below the reamer guide housing, with both threaded onto opposite ends of the reamer guide, as taught by Zehnder, so that the guide knob and locking pin can be tightened against the guide housing when the reamer guide has reached the desired position along the first axis to lock the reamer guide firmly in the desired position for subsequent reaming without accidentally dislodging the position of the reamer guide (and reamer shaft therein) which could result in reaming in an undesired area. The locking pin prevents the reamer guide from falling out of the cavity because it is enlarged relative to the housing so that the reamer guide and locking pin threaded to it would not pass through the cavity, and, when the locking pin and the guide knob are tightened, they lock the reamer guide to the guide housing so that the reamer guide would not fall out of the cavity.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over JP-5412334 to Matsubara in view of Wilson (hereinafter, “Matsubara/Wilson”), as applied to claims 1, 3, 4, 6-8, 10, 14, 17, and 18 above, and further in view of U.S. Patent No. US 8,048,166 to Brown et al. (hereinafter, “Brown”).
Matsubara/Wilson are silent as to further comprising an adjustment knob and a threaded shaft extending from the adjustment knob into the cavity of the reamer guide housing and engaging the reamer guide such that rotation of the adjustment knob slides the reamer guide along the housing rails and along the first axis.
Brown teaches an adjustment knob (head of 124) and a threaded shaft (shaft of 124) extending from the adjustment knob into a cavity (negative space between 104 and 120) of a housing, FIG. 14, and engaging a guide (126) such that rotation of the adjustment knob slides the guide along a first axis (col. 6 / line 62 – col. 7 / line 24).
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 Matsubara/Wilson an adjustment knob and a threaded shaft extending from the adjustment knob, as taught by Brown, into the cavity of the reamer guide housing and engaging the reamer guide such that rotation of the adjustment knob slides the reamer guide along the housing rails and along the first axis, since Brown teaches that such a worm drive allows for incrementally adjustable sliding of one part within another part, which would enable the reamer guide in Matsubara/Wilson to be moved with precision into a highly accurate reaming position relative to the reamer guide housing along the first axis. The threaded shaft would extend through, for example, the side 55C of the reamer guide housing and into a side of the reamer guide to pull or push the reamer guide relative to the side 55C, therefore also positioning the reamer shaft and reamer head relative to the scoop assembly.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over JP-5412334 to Matsubara in view of Wilson (hereinafter, “Matsubara/Wilson”), as applied to claims 1, 3, 4, 6-8, 10, 14, 17, and 18 above, and further in view of U.S. Patent No. US 9,760,172 to Ray et al. (hereinafter, “Ray”).
Matsubara/Wilson are silent as to further comprising a shim positioned within the cavity of the reamer guide housing, the shim being configured to limit movement of the reamer guide along the first axis (claim 15); wherein the shim is sized such that when the shim is positioned within the cavity of the reamer guide housing to define a spacing between the scoop assembly and the acetabular reamer assembly, operation of the scoop assembly and the acetabular reamer assembly on a bone surface is configured to produce surfaces sized to receive an acetabular wedge augment having a first predetermined size and an acetabular cup having a second predetermined size (claim 16).
Ray teaches inserting a shim into a track in which a slide travels to define travel limits (col. 9 / lines 28-32).
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 Matsubara/Wilson a shim positioned within the cavity of the reamer guide housing, the shim configured to limit movement of the reamer guide along the first axis, since Ray teaches that a shim inserted into a track in which a slide travels can define travel limits of the slide. The shim would be sized to provide a desired, limited range of movement of the reamer guide along the first axis, for example to maintain the reamer at a certain distance from the scoop (further apart when the shim is between the reamer and scoop or closer together when the reamer is between the shim and the scoop), based on the patient bone morphology and the target bone to ream. The shim is sized such that when the shim is positioned within the cavity of the reamer guide housing to define a spacing between the scoop assembly and the acetabular reamer assembly (defined by the shim-limited range of movement of the reamer assembly as it moves relative to the scoop assembly), operation of the scoop assembly and the acetabular reamer assembly on a bone surface is fully capable of producing surfaces sized to receive an acetabular wedge augment having a first predetermined size and an acetabular cup having a second predetermined size (interpreted as language of intended use).
Allowable Subject Matter
Claims 2, 5, and 11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance: None of the searched, pertinent prior art clearly shows by itself, or in combination with each other, an acetabular wedge augment reaming tool as recited in claim 2 or claim 11. The closest prior art to Matsubara (JP-5412334) discloses a scoop assembly having a scoop (20) and a scoop shaft (41), FIG. 7, wherein the scoop is modularly connected to a distal end of the scoop shaft of the scoop assembly but does not disclose the scoop assembly includes a housing shaft connected to and extending from the reamer guide housing, the scoop shaft being received within the housing shaft so that the distal end of the scoop shaft extends from a distal end of the housing shaft, as required by claim 2. Matsubara discloses a reamer head (52) and a scoop (20) but does not disclose the reamer head has a second diameter equal to a first diameter of a convex exterior of the scoop, as required by claim 11.
It would not have been obvious in view of the cited art to make modifications to resolve the above deficiencies and arrive at the claimed invention.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong, can be reached at 571-272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights