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 .
Priority
The priority date is 13 June 2022.
Claim Objections
Claims 1-20 are objected to because of the following informalities: improper antecedence and grammar. Appropriate correction is required. The following amendments are suggested:
Claim 1 / line 5: “and a slot”
Claim 1 / line 8: “a third indicia configured to indicate”
Claim 11 / lines 1-2: “and [[can]] travels”
Claim 13 / line 5: “and a slot”
Claim 13 / line 11: “the post assembly”
Claim 18 / line 3: “a third indicia configured to indicate”
Claim 19 / line 5: “and a slot”
Claim 19 / line 9: “a third indicia configured to indicate”
Claim 20 / line 1: “includes a cap”
Claim 20 / line 2: “the ball of the ball and spring assembly,”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3, 4, 8-11 and 13 are rejected under 35 U.S.C. 102(a)(1)/(2) as anticipated by U.S. Patent No. US 9,050,197 to Lorio et al. (hereinafter, “Lorio”).
As to claim 1, Lorio discloses an orthopedic instrument for a knee arthroplasty, FIGS. 1-8, the instrument comprising: a base (201) having one or more paddles (210M, 210L) configured to seat against and reference one or both of a medial condyle and a lateral condyle of a femur (col. 6 / lines 21-24), FIGS. 7-8; a body (120 and 110A) linked to the base for rotation relative thereto (col. 4 / lines 33-34), FIG. 1, wherein the body includes a recess (180) and slot (slot that opens into 180 on the first face of 120) therein and a first indicia (184) along a first face of the body adjacent the slot (col. 4 / lines 59-61; col. 6 / lines 44-48), FIG. 3; a post (136, 138) received in the recess and moveable relative to the body (col. 4 / lines 62-65), wherein the post has a second indicia (set screw shown in the exploded view of FIG. 3 that passes through the slot to enter the hole at the base of 138) used with the first indicia to determine a posterior size of the femur (col. 4 / line 65 – col. 5 / line 2), shown in another embodiment in FIGS. 9 and 16; and an adjustment mechanism (260 and 270) having a third indicia (286) to indicate a rotation of the femur (col. 5 / line 36 – col. 6 / line 15), wherein the adjustment mechanism is configured to rotate the body relative to the base (the body and the base rotate relative to each other, col. 4 / lines 33-34) to a desired orientation based upon the rotation of the femur.
As to claim 3, Lorio discloses the instrument of claim 1, wherein the adjustment mechanism comprises a dial (272) with a handle (274) configured for hand adjustment of the dial by a surgeon (col. 5 / lines 42-45), FIGS. 1 and 3.
As to claim 4, Lorio discloses the instrument of claim 1, wherein the post comprises an assembly including an outer sleeve (138), an inner shaft (136) and a cap (head of 136), wherein the outer sleeve translates but is rotationally fixed relative to the body (due to the set screw that slides in the slot of the body at 120) but the inner shaft is configured for rotation relative to the outer sleeve and the body (col. 4 / lines 63-65).
As to claim 8, Lorio discloses the instrument of claim 4, wherein the outer sleeve is rotationally fixed relative to the body by a projection (set screw) that defines the second indicia, wherein the projection is captured in the slot, shown in the exploded view in FIG. 3.
As to claim 9, Lorio discloses the instrument of claim 1, wherein the body (120 and 110A) includes a plurality of guide apertures (holes through 142s on 110A) therein (col. 6 / lines 37-39), FIGS. 1-3, and the base (201) includes a second plurality of guide apertures (207) therein (col. 6 / lines 19-21), FIGS. 1-3.
As to claim 10, Lorio discloses the instrument of claim 1, wherein the base includes a recess (circular recess in 220), a pawl (226) and a slot (230) (col. 5 / lines 52-61), FIG. 6, wherein the adjustment mechanism is a dial (272) that is rotatably inserted in the recess and configured to selectively engage the pawl with a ratchet (278) (col. 5 / lines 48-58), and wherein the slot (230) is configured to receive an arm (264) that links the base to the body (col. 5 / line 59 – col. 6 / line 3), FIGS. 3 and 5.
As to claim 11, Lorio discloses the instrument of claim 10, wherein the arm (264) is engaged by the dial (272) and can travel within an arcuate groove (276) within the dial (col. 5 / line 62 – col. 6 / line 3), FIG. 5.
As to claim 13, Lorio discloses an orthopedic instrument for a knee arthroplasty, FIGS. 1-8, the instrument comprising: a base (201) having one or more paddles (210M, 210L) configured to seat against and reference one or both of a medial condyle and a lateral condyle of a femur (col. 6 / lines 21-24), FIGS. 7-8; a body (120 and 110A) linked to the base for rotation relative thereto (col. 4 / lines 33-34), FIG. 1, wherein the body includes a recess (180) and slot (slot that opens into 180 on the first face of 120) therein and a first indicia (184) along a first face of the body adjacent the slot (col. 4 / lines 59-61; col. 6 / lines 44-48), FIG. 3; a post assembly (136, 138) received in the recess and moveable relative to the body (col. 4 / lines 62-65), wherein the post assembly includes an outer sleeve (138), an inner shaft (136) and a cap (head of 136), wherein the outer sleeve translates but is rotationally fixed relative to the body (due to the set screw that slides in the slot of the body at 120) but the inner shaft is configured for rotation relative to the outer sleeve and the body (col. 4 / lines 63-65), and wherein the post has a second indicia (set screw shown in the exploded view of FIG. 3 that passes through the slot to enter the hole at the base of 138) used with the first indicia to determine a posterior size of the femur (col. 4 / line 65 – col. 5 / line 2), shown in another embodiment in FIGS. 9 and 16; and a stylus (130) coupled to the post by the cap, FIG. 1, and moveable relative thereto (at least for insertion).
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Lorio.
Lorio is silent as to wherein the body via the adjustment mechanism is capable of eighteen degrees of rotation, inclusive, relative to the base.
Lorio contemplates that the actual rotation angle of the dial (272) is “x” and the relative rotation between the body (at 110A) and the base (201) is “y”, then a rotation transmission ratio is equal to "x" divided by "y" where a rotation transmission ratio of about 5 to about 20 can be used (col. 6 / lines 4-15). As shown in FIG. 7, the actual rotation angle of the dial is about 140 degrees (“x”=140, where the third indicia 286 spans about 140 degrees for equivalent rotation of the dial).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide a rotation transmission ratio of about 7.77, since this falls within the range of the rotation transmission ratio disclosed by Lorio, and since discovering an optimum value of a result effective variable involves only routine skill in the art. Then, solving for “y” where x/y=7.77 and “x”=140 results in y=18 degrees. Therefore, the relative rotation between the body (at 110A) and the base (201) is 18 degrees.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Lorio in view of U.S. Patent No. 5,275,603 to Ferrante et al. (hereinafter, “Ferrante”), U.S. Patent No. US 7,175,630 to Farling et al. (hereinafter, “Farling”), and U.S. Patent No. US 8,734,453 to Tuttle et al. (hereinafter, “Tuttle”).
As to claim 2, Lorio is silent as to further comprising a plurality of retention mechanisms each comprising a ball and spring assembly, wherein the plurality of retention mechanisms are positioned between various components including at least the base and the body, the post and the body and the post and a stylus.
Ferrante teaches an orthopedic instrument comprising a base (14) and a body (guide means including flange 49) linked to the base for rotation relative thereto (col. 3 / lines 29-31), FIG. 2, further comprising a retention mechanism comprising a ball and spring assembly (38; a ball plunger is a spring loaded ball) positioned between the base and the body (col. 3 / lines 44-53) to releasably lock the base and the body relative to each other in a particular angular 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 a retention mechanism comprising a ball and spring assembly (a spring loaded ball, which comprises a ball and spring element) positioned between the base and the body in Lorio to releasably lock the base and the body relative to each other in a particular angular position, so that a certain amount of excess force is required to overcome the pressure exerted by the ball and spring assembly to prevent unintended and undesired relative movement of the base and body, as taught by Ferrante. Lorio’s base would be provided with a ball and spring assembly protruding out of a face facing the body (at 110A), and the body would be provided with indents as taught by Ferrante in a face facing the base, so that the ball and spring assembly engages one of the indents to releasably lock the base and the body in that particular rotational/angular position.
Farling teaches an orthopedic instrument comprising a body (100) that includes a recess (130), FIG. 1; a post (202) received in the recess and moveable relative to the body; further comprising a retention mechanism comprising a ball and spring assembly (138, biased ball detent, which comprises a ball and spring element) positioned between the post and the body to create a frictional force to help maintain the post in a user selected position while permitting easy readjustment (col. 2 / lines 31-38).
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 a retention mechanism comprising a ball and spring assembly (a biased ball detent, which comprises a ball and spring element) positioned between the post and the body in Lorio to create a frictional force to help maintain the post in a user selected position while permitting easy readjustment, as taught by Farling. Lorio’s body (at 120) would be provided with a ball and spring assembly protruding into the recess that receives the post, to be biased against a side of the post when inserted therein to create the frictional force to help maintain the post in a user selected position while permitting easy readjustment.
Tuttle teaches an orthopedic instrument comprising a post (101) and a stylus (100), and a retention mechanism comprising a ball and spring assembly (a ball plunger is a spring loaded ball) positioned between the post and the stylus (col. 29 / lines 2-5), FIG. 3P, to selectively engage the stylus to releasably lock the stylus in position with respect to the post.
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 a retention mechanism comprising a ball and spring assembly (a spring loaded ball, which comprises a ball and spring element) positioned between the post and the stylus in Lorio to releasably lock the stylus in position with respect to the post, so that a certain amount of excess force is required to overcome the pressure exerted by the ball and spring assembly to prevent unintended and undesired relative movement of the stylus, as taught by Tuttle. Lorio’s cap on the top of the post would be provided with an aperture that receives the spring loaded ball which protrudes out of the aperture, and Lorio’s stylus would be provided with a plurality of detents on the inferior face of the stylus facing the spring loaded ball in the aperture of the cap, so that the spring loaded ball engages one of the detents to releasably lock the stylus in the particular longitudinal position with respect to the cap and post.
Claims 5-7, 14-17, 19, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lorio in view of Tuttle.
As to claim 5, Lorio discloses further comprising a stylus (130) coupled to the post by the cap, FIG. 1, and moveable relative thereto (at least for insertion).
As to claim 6, Lorio discloses wherein the cap includes one or more grooves (recesses under projections on either side of/forming the dovetail groove) and one or more projections (projections on either side of/forming the dovetail groove), and wherein the stylus includes one or more lateral projections (longitudinally extending edges) each configured to be received in one of the one or more grooves, FIGS. 1-3.
Lorio is silent as to wherein the cap includes an aperture that receives a ball, and wherein the stylus includes a plurality of detents each configured to be engaged by the ball (claim 5); wherein the inner shaft is configured to retain a spring that engages the ball, wherein the ball is biased by the spring against the stylus (claim 7).
Tuttle teaches an orthopedic instrument comprising a post (101) and a stylus (100), and a retention mechanism comprising a ball and spring assembly (a ball plunger is a spring loaded ball) positioned between the post and the stylus (col. 29 / lines 2-5), FIG. 3P, to selectively engage the stylus to releasably lock the stylus in position with respect to the post. Tuttle teaches the stylus includes a plurality of detents each configured to be engaged by the ball, FIG. 3P, wherein the ball is biased against the stylus.
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 a retention mechanism comprising a ball and spring assembly (a spring loaded ball, which comprises a ball and spring element) positioned between the post and the stylus in Lorio to releasably lock the stylus in position with respect to the post, so that a certain amount of excess force is required to overcome the pressure exerted by the ball and spring assembly to prevent unintended and undesired relative movement of the stylus, as taught by Tuttle. Lorio’s cap on the top of the post would be provided with an aperture that receives the spring loaded ball which protrudes out of the aperture, and Lorio’s stylus would be provided with a plurality of detents on the inferior face of the stylus facing the spring loaded ball in the aperture of the cap, so that the spring loaded ball engages one of the detents to releasably lock the stylus in the particular longitudinal position with respect to the cap and post. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the spring element retained in the inner shaft, since the cap comprises the head of the inner shaft and the ball protrudes, by spring force, out of the aperture in the cap, so that the spring element would be proximal to the ball, inside the inner shaft, to bias the ball outward from the inner shaft/cap on the head of the inner shaft.
As to claim 15, Lorio discloses the instrument of claim 14, wherein the cap includes one or more grooves (recesses under projections on either side of/forming the dovetail groove) and one or more projections (projections on either side of/forming the dovetail groove), and wherein the stylus includes one or more lateral projections (longitudinally extending edges) each configured to be received in one of the one or more grooves, FIGS. 1-3.
As to claim 17, Lorio discloses the instrument of claim 16, wherein the outer sleeve is rotationally fixed relative to the body by a projection (set screw) that defines the second indicia, wherein the projection is captured in the slot, shown in the exploded view in FIG. 3.
Lorio is silent as to wherein the cap includes an aperture that receives a ball, and wherein the stylus includes a plurality of detents each configured to be engaged by the ball (claim 14); wherein the inner shaft is configured to retain a spring that engages the ball, wherein the ball is biased by the spring against the stylus (claim 16).
Tuttle teaches an orthopedic instrument comprising a post (101) and a stylus (100), and a retention mechanism comprising a ball and spring assembly (a ball plunger is a spring loaded ball) positioned between the post and the stylus (col. 29 / lines 2-5), FIG. 3P, to selectively engage the stylus to releasably lock the stylus in position with respect to the post. Tuttle teaches the stylus includes a plurality of detents each configured to be engaged by the ball, FIG. 3P, wherein the ball is biased against the stylus.
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 a retention mechanism comprising a ball and spring assembly (a spring loaded ball, which comprises a ball and spring element) positioned between the post and the stylus in Lorio to releasably lock the stylus in position with respect to the post, so that a certain amount of excess force is required to overcome the pressure exerted by the ball and spring assembly to prevent unintended and undesired relative movement of the stylus, as taught by Tuttle. Lorio’s cap on the top of the post would be provided with an aperture that receives the spring loaded ball which protrudes out of the aperture, and Lorio’s stylus would be provided with a plurality of detents on the inferior face of the stylus facing the spring loaded ball in the aperture of the cap, so that the spring loaded ball engages one of the detents to releasably lock the stylus in the particular longitudinal position with respect to the cap and post. It further would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the spring element retained in the inner shaft, since the cap comprises the head of the inner shaft and the ball protrudes, by spring force, out of the aperture in the cap, so that the spring element would be proximal to the ball, inside the inner shaft, to bias the ball outward from the inner shaft/cap on the head of the inner shaft.
As to claim 19, Lorio discloses an orthopedic instrument for a knee arthroplasty, FIGS. 1-8, the instrument comprising: a base (201) having one or more paddles (210M, 210L) configured to seat against and reference one or both of a medial condyle and a lateral condyle of a femur (col. 6 / lines 21-24), FIGS. 7-8; a body (120 and 110A) linked to the base for rotation relative thereto (col. 4 / lines 33-34), FIG. 1, wherein the body includes a recess (180) and slot (slot that opens into 180 on the first face of 120) therein and a first indicia (184) along a first face of the body adjacent the slot (col. 4 / lines 59-61; col. 6 / lines 44-48), FIG. 3; a post (136, 138) received in the recess and moveable relative to the body (col. 4 / lines 62-65), wherein the post has a second indicia (set screw shown in the exploded view of FIG. 3 that passes through the slot to enter the hole at the base of 138) used with the first indicia to determine a posterior size of the femur (col. 4 / line 65 – col. 5 / line 2), shown in another embodiment in FIGS. 9 and 16; a stylus (130) coupled to the post and moveable relative thereto (at least for insertion); an adjustment mechanism (260 and 270) having a third indicia (286) to indicate a rotation of the femur (col. 5 / line 36 – col. 6 / line 15), wherein the adjustment mechanism is configured to rotate the body relative to the base (the body and the base rotate relative to each other, col. 4 / lines 33-34) to a desired orientation based upon the rotation of the femur.
As to claim 20, Lorio discloses the instrument of claim 19, wherein the post includes cap (head of 136), wherein the cap includes one or more grooves (recesses under projections on either side of/forming the dovetail groove) and one or more projections (projections on either side of/forming the dovetail groove), and wherein the stylus includes one or more lateral projections (longitudinally extending edges) each configured to be received in one of the one or more grooves, FIGS. 1-3.
Lorio is silent as to a ball and spring assembly configured to retain the stylus with the post (claim 19); wherein the cap has an aperture that receives the ball, wherein the stylus includes a plurality of detents each configured to be engaged by the ball (claim 20).
Tuttle teaches an orthopedic instrument comprising a post (101) and a stylus (100), and a ball and spring assembly (a ball plunger is a spring loaded ball) positioned between the post and the stylus (col. 29 / lines 2-5), FIG. 3P, to selectively engage the stylus to releasably lock the stylus in position with respect to the post. Tuttle teaches the stylus includes a plurality of detents each configured to be engaged by the ball, FIG. 3P, wherein the ball is biased against the stylus.
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 a retention mechanism comprising a ball and spring assembly (a spring loaded ball, which comprises a ball and spring element) positioned between the post and the stylus in Lorio to releasably lock the stylus in position with respect to the post, so that a certain amount of excess force is required to overcome the pressure exerted by the ball and spring assembly to prevent unintended and undesired relative movement of the stylus, as taught by Tuttle. Lorio’s cap on the top of the post would be provided with an aperture that receives the spring loaded ball which protrudes out of the aperture, and Lorio’s stylus would be provided with a plurality of detents on the inferior face of the stylus facing the spring loaded ball in the aperture of the cap, so that the spring loaded ball engages one of the detents to releasably lock the stylus in the particular longitudinal position with respect to the cap and post.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Lorio in view of Tuttle (hereinafter, “Lorio/Tuttle”), as applied to claims 5-7, 14-17, 19, and 20 above, and further in view of Ferrante and Farling.
As to claim 18, Lorio/Tuttle disclose further comprising: an adjustment mechanism (260 and 270) having a third indicia (286) to indicate a rotation of the femur (col. 5 / line 36 – col. 6 / line 15), wherein the adjustment mechanism is configured to rotate the body relative to the base (the body and the base rotate relative to each other, col. 4 / lines 33-34) to a desired orientation based upon the rotation of the femur.
Lorio/Tuttle are silent as to a plurality of retention mechanisms each comprising a ball and spring assembly, wherein the plurality of retention mechanisms are positioned between various components including at least the base and the body and the post assembly and the body.
Ferrante teaches an orthopedic instrument comprising a base (14) and a body (guide means including flange 49) linked to the base for rotation relative thereto (col. 3 / lines 29-31), FIG. 2, further comprising a retention mechanism comprising a ball and spring assembly (38; a ball plunger is a spring loaded ball) positioned between the base and the body (col. 3 / lines 44-53) to releasably lock the base and the body relative to each other in a particular angular 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 a retention mechanism comprising a ball and spring assembly (a spring loaded ball, which comprises a ball and spring element) positioned between the base and the body in Lorio to releasably lock the base and the body relative to each other in a particular angular position, so that a certain amount of excess force is required to overcome the pressure exerted by the ball and spring assembly to prevent unintended and undesired relative movement of the base and body, as taught by Ferrante. Lorio’s base would be provided with a ball and spring assembly protruding out of a face facing the body (at 110A), and the body would be provided with indents as taught by Ferrante in a face facing the base, so that the ball and spring assembly engages one of the indents to releasably lock the base and the body in that particular rotational/angular position.
Farling teaches an orthopedic instrument comprising a body (100) that includes a recess (130), FIG. 1; a post assembly (202) received in the recess and moveable relative to the body; further comprising a retention mechanism comprising a ball and spring assembly (138, biased ball detent, which comprises a ball and spring element) positioned between the post assembly and the body to create a frictional force to help maintain the post assembly in a user selected position while permitting easy readjustment (col. 2 / lines 31-38).
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 a retention mechanism comprising a ball and spring assembly (a biased ball detent, which comprises a ball and spring element) positioned between the post assembly and the body in Lorio to create a frictional force to help maintain the post assembly in a user selected position while permitting easy readjustment, as taught by Farling. Lorio’s body (at 120) would be provided with a ball and spring assembly protruding into the recess that receives the post assembly, to be biased against a side of the post assembly when inserted therein to create the frictional force to help maintain the post assembly in a user selected position while permitting easy readjustment.
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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/TRACY L KAMIKAWA/Examiner, Art Unit 3775