DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claim 13 is objected to because of the following informalities:
in claim 13, line 25: “the sensor module” should be “the sensor array”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, 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.
Claim 1 recites “a substantially planar upper surface” in lines 8-9 and “a substantially planar bottom surface” in line 20, which contain the relative terms “substantially planar” that renders the claim indefinite. The term “substantially planar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how one is to judge whether a surface is substantially planar. What metrics are used and how are those metrics judged? These issues render claim 1 indefinite.
Claims 2-12 are rejected by virtue of their dependence from claim 1.
Claim 13 recites “a substantially planar upper surface” in lines 6-7, which contains the relative term “substantially planar” that renders the claim indefinite. The term “substantially planar” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear how one is to judge whether a surface is substantially planar. What metrics are used and how are those metrics judged? These issues render claim 13 indefinite.
Claims 14-19 are rejected by virtue of their dependence from claim 13.
Claim 17 recites “the relative positions of the patient’s tibia and femur” in line 2 in which there is insufficient antecedent basis for this recitation in the claim.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-9 and 11-12 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 7,575,602 (Amirouche)(previously cited), in view of U.S. Patent Application Publication No. 2005/0177170 (Fisher)(previously cited).
Amirouche teaches a method for performing an orthopaedic surgical procedure on a knee joint of a patient, the method comprising: resecting a proximal end of a patient’s tibia to create a resected surface of the patient’s tibia (see FIG. 3 of Amirouche) and positioning a surgical instrument assembly between the resected proximal end of the patient’s tibia and a distal end of the patient’s femur, the surgical instrument assembly including curved surfaces shaped to engage corresponding curved surfaces of a femoral component (the femoral component 32 of Amirouche) attached to the distal end of the patient’s femur, and a plurality of imbedded sensors 35 attached to the underside of the spacer 34 (FIGS. 4-5 of Amirouche). Amirouche discloses that the sensors 35 are contained within the elevated surface 72 and that the elevated surface 72 may be fitted between the spacer 34 and the tibial tray 58 (col. 4, lines 40-55 of Amirouche). Amirouche also discloses that the interaction between the spacer 34 and the tibial tray 58 may vary to other known design variations (col. 4, lines 45-55 of Amirouche).
Amirouche teaches the use of a spacer 34 with the plurality of imbedded sensors 35 positioned below it and the recesses 66 and 68 positioned on its upper surface (FIGS. 4-5 of Amirouche). Fisher discloses splitting such a spacer into two parts 414 and 416 (FIG. 6 of Fisher). It would have been obvious to one of ordinary skill in the art at the time of invention to split the spacer 34 of Amirouche into two parts 414 and 416 since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it permits more flexibility in the use of the device.
Fisher discloses a handle protruding from the sensor plate 412 with a pair of displays so as to provide pressure on a lateral side and a medial side of the knee (paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher). It would have been obvious to one of ordinary skill in the art at the time of invention to include a handle on one of the pieces of the two-piece spacer of Amirouche on which the sensor array 35 of Amirouche is placed, the handle having a pair of displays showing pressure on a lateral side and a medial side of the knee, so as to provide feedback about the medial-lateral joint force balance of the knee while looking at the knee itself and to provide an easy method of manipulating the spacer(s).
With respect to claim 1, the combination teaches or suggests a method for performing an orthopaedic surgical procedure on a knee joint of a patient, the method comprising:
resecting a proximal end of the patient’s tibia to create a resected surface of the patient’s tibia (see FIG. 3 of Amirouche),
performing a balancing procedure on the patient’s knee joint to achieve a target joint force balance between the patient’s tibia and the patient’s femur (the initial procedure which leads to adjustments and improvements that are later made based on the force balance displays; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher);
positioning a tibial paddle of a sensor module on the resected surface of the patient’s tibia, the tibial paddle having an upper housing (the adaptor plate 414 suggested by Fisher) with a substantially planar upper surface and a lower housing (the tibial tray 58 of Amirouche) opposite from and coupled to the upper housing, wherein the tibial paddle includes a sensor array (the plurality of imbedded sensors 35 of Amirouche) located between a portion of the lower housing and a corresponding portion of the upper housing and configured to detect joint forces in the patent’s knee joint and transmit joint force data indicative of the joint forces to a display instrument,
placing a tibial trial bearing (the upper plate 416 suggested by Fisher) on the substantially planar upper surface of the upper housing (the adaptor plate 414 suggested by Fisher) of the tibial paddle of the sensor module while the tibial paddle is positioned on the resected surface of the patient’s tibia, the tibial trial bearing having curved surfaces (the condyle recesses 66 and 68 of Amirouche) shaped to engage corresponding curved surfaces of a femoral component (the femoral component 32 of Amirouche) attached to a distal end of the patient’s femur and a substantially planar bottom surface that confronts the substantially planar upper surface of the tibial paddle when the tibial trial bearing is placed on the tibial paddle of the sensor module;
moving the patient’s knee joint through a range of flexion with the tibial paddle of the sensor module positioned between the resected proximal end of the patient’s tibia and the distal end of the patient’s femur while the sensor module transmits the joint force data to the display instrument (the measurements are taken during the full range of motion; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; the wireless transmission; abstract, col. 5, line 25 to col. 6, line 3, and claim 1 of Amirouche),
monitoring a display of the display instrument to determine whether a present joint force balance indicated by the joint force data matches the target joint force balance, the display providing a visual indication of an anatomical performance of the patient’s knee joint based on the joint force data received from the sensor array (observing the display during the movements; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher), and
performing another balancing procedure on the patient’s knee joint to improve the matching of the present joint force balance to the target joint force balance as indicated by the display of the display instrument (adjustments and improvements are made based on the display of force balance data during the movements; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher).
With respect to claim 2, the combination teaches or suggests that the joint force data includes medial-lateral force data (the force data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher).
With respect to claim 3, the combination teaches or suggests that the joint force data includes data indicative of relative locations of the patient’s tibia and femur (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 4, the combination teaches or suggests that the joint force data includes flexion angle data (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 5, the combination teaches or suggests that the joint force data includes relative positions of the patient’s tibia and femur (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 6, the combination teaches or suggests that the joint force data includes flexion angle data (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 7, the combination teaches or suggests that the sensor array includes a first plurality of pressure sensors that are positioned below a first curved surface of the curved surfaces of the tibial trial bearing, and the sensor array includes a second plurality of pressure sensors that are positioned below a second curved surface of the curved surfaces of the tibial trial bearing (FIGS. 3-5 of Amirouche; the plurality of imbedded sensors 35 below the recesses 66 and 68 of Amirouche).
With respect to claim 8, the combination teaches or suggests that the visual indication comprises a graph of one of the joint forces in the patient’s knee joint versus flexion angle of the patient’s knee joint (the joint force versus position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 9, the combination teaches or suggests that the joint force data includes a medial joint force value and a lateral joint force value of the patient’s knee joint (the handle of Fisher protruding from the spacer 34 of Amirouche with a pair of displays of Fisher displaying an indication of the medial-lateral joint force balance by displaying the pressure on a lateral side and a medial side of the knee).
With respect to claim 11, the combination teaches or suggests that the anatomical performance of the patient’s knee joint includes a pressure of the patient’s knee joint (the handle of Fisher protruding from the spacer 34 of Amirouche with a pair of displays of Fisher displaying an indication of the medial-lateral joint force balance by displaying the pressure on a lateral side and a medial side of the knee).
With respect to claim 12, the combination teaches or suggests that the positioning the tibial paddle of the sensor module comprises positioning the tibial paddle between the resected proximal end of the patient’s tibia and the distal end of the patient’s femur (FIG. 3 of Amirouche) using a handle of the tibial paddle (using the handle of Fisher to manipulate the plurality of imbedded sensors 35 of Amirouche).
Claim 10 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 7,575,602 (Amirouche)(previously cited), in view of U.S. Patent Application Publication No. 2005/0177170 (Fisher)(previously cited), and further in view of U.S. Patent Application Publication No. 2010/0191068 (Bewernitz)(previously cited).
Amirouche teaches that the visual indication comprises a graph of the joint forces in the patient’s knee joint versus flexion angle of the patient’s knee joint (the joint force versus position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche). Bewernitz teaches that the average of the joint forces is also a useful parameter (paragraph 0030 of Bewernitz). It would have been obvious to one of ordinary skill in the art at the time of invention to calculate and display a graph of the average joint forces versus flexion angle since it provides a more complete picture of the joint forces at the knee.
With respect to claim 10, the combination teaches or suggests that the joint force data includes an average joint force value based on the medial joint force value and the lateral joint force value (the medial joint force and lateral joint force values of Amirouche and the average joint force suggested by Bewernitz are determined).
Claims 13-19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 7,575,602 (Amirouche)(previously cited), in view of U.S. Patent Application Publication No. 2005/0177170 (Fisher)(previously cited), and further in view of U.S. Patent Application Publication No. 2009/0005708 (Johanson)(previously cited), and further in view of U.S. Patent No. 7,892,236 (Bonutti)(previously cited).
Amirouche teaches a method for performing an orthopaedic surgical procedure on a knee joint of a patient, the method comprising: resecting a proximal end of a patient’s tibia to create a resected surface of the patient’s tibia (see FIG. 3 of Amirouche) and positioning a surgical instrument assembly between the resected proximal end of the patient’s tibia and a distal end of the patient’s femur, the surgical instrument assembly including curved surfaces shaped to engage corresponding curved surfaces of a femoral component (the femoral component 32 of Amirouche) attached to the distal end of the patient’s femur, and a plurality of imbedded sensors 35 attached to the underside of the spacer 34 (FIGS. 4-5 of Amirouche). Amirouche discloses that the sensors 35 are contained within the elevated surface 72 and that the elevated surface 72 may be fitted between the spacer 34 and the tibial tray 58 (col. 4, lines 40-55 of Amirouche). Amirouche also discloses that the interaction between the spacer 34 and the tibial tray 58 may vary to other known design variations (col. 4, lines 45-55 of Amirouche).
Amirouche teaches the use of a spacer 34 with the plurality of imbedded sensors 35 positioned below it and the recesses 66 and 68 positioned on its upper surface (FIGS. 4-5 of Amirouche). Fisher discloses splitting such a spacer into two parts 414 and 416 (FIG. 6 of Fisher). It would have been obvious to one of ordinary skill in the art at the time of invention to split the spacer 34 of Amirouche into two parts 414 and 416 since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it permits more flexibility in the use of the device.
Fisher discloses a handle protruding from the sensor plate 412 with a pair of displays so as to provide pressure on a lateral side and a medial side of the knee (paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher). It would have been obvious to one of ordinary skill in the art at the time of invention to include a handle on one of the pieces of the two-piece spacer of Amirouche on which the sensor array 35 of Amirouche is placed, the handle having a pair of displays showing pressure on a lateral side and a medial side of the knee, so as to provide feedback about the medial-lateral joint force balance of the knee while looking at the knee itself and to provide an easy method of manipulating the spacer(s).
Johanson teaches that assessment of knee alignment or stability using such pressure sensors can be used in conjunction with joint distraction (paragraph 0059 of Johanson). Bonutti teaches that a distraction device may be used on the media and lateral sides of the knee portion (col. 67, lines 40-51 of Bonutti). It would have been obvious to one of ordinary skill in the art at the time of invention to perform joint distraction using the distraction device of Bonutti during the assessment of knee alignment or stability as disclosed by Amirouche since it provides a method of achieving optimal fit for the prosthesis.
With respect to claim 13, the combination teaches or suggests a method for performing an orthopaedic surgical procedure on a knee joint of a patient, the method comprising:
resecting a proximal end of the patient’s tibia to create a resected surface of the patient’s tibia (see FIG. 3 of Amirouche),
positioning a tibial paddle of a sensor module on the resected surface of the patient’s tibia, the tibial paddle including an upper housing (the adaptor plate 414 suggested by Fisher) having a substantially planar upper surface and a lower housing (the tibial tray 58 of Amirouche) opposite from and coupled to the upper housing, wherein the tibial paddle includes a sensor array (the plurality of imbedded sensors 35 of Amirouche) located between the lower housing and the upper housing and configured to detect joint forces in the patent’s knee joint and transmit joint force data indicative of the joint forces to a display instrument,
positioning a joint distractor in the patient’s knee joint such that a medial tibial paddle and a lateral tibial paddle of the joint distractor contact the upper housing of the tibial paddle (positioning the joint distractor of Bonutti for joint distraction during the assessment of knee alignment or stability),
distracting the patient’s knee joint while the patient’s knee joint is in extension using the joint distractor (the joint distractor of Bonutti being used for joint distraction during the assessment of knee alignment or stability),
performing a balancing procedure on the patient’s knee joint while the patient’s knee joint is in extension and distracted (the assessment of knee alignment or stability of the combination),
removing the joint distractor from the patent’s knee joint (the eventual removal of the joint distractor of Bonutti after the assessment of knee alignment or stability of the combination),
placing a tibial trial bearing (the upper plate 416 suggested by Fisher) on the substantially planar upper surface of the upper housing (the adaptor plate 414 suggested by Fisher) of the tibial paddle while the tibial paddle is positioned on the resected surface of the patient’s tibia;
moving the patient’s knee joint through a range of flexion with the sensor module positioned between the resected proximal end of the patient’s tibia and a distal end of the patient’s femur while the sensor module transmits the joint force data to the display instrument (the measurements are taken during the full range of motion during the assessment of knee alignment or stability of the combination; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; the wireless transmission; abstract, col. 5, line 25 to col. 6, line 3, and claim 1 of Amirouche),
monitoring a display of the display instrument, the display providing a visual indication of the joint force balance of the patient’s knee joint based on the joint force data received from the sensor array (observing the display during the movements during the assessment of knee alignment or stability of the combination; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher).
With respect to claim 14, the combination teaches or suggests that the joint force data includes medial-lateral force data (the force data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher).
With respect to claim 15, the combination teaches or suggests that the joint force data includes data indicative of relative locations of the patient’s tibia and femur (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 16, the combination teaches or suggests that the joint force data includes flexion angle data (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 17, the combination teaches or suggests that the joint force data includes the relative positions of the patient’s tibia and femur (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 18, the combination teaches or suggests that the joint force data includes flexion angle data (the position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
With respect to claim 19, the combination teaches or suggests that the visual indication comprises a graph of one of the joint forces in the patient’s knee joint versus flexion angle of the patient’s knee joint (the joint force versus position/angle data are displayed; col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche).
Response to Arguments
The Applicant’s arguments filed on 12/7/2025 have been fully considered.
Claim objections
In view of the claim amendments filed on 12/7/2025, the previous claim objections are withdrawn.
There are new grounds of claim objections that were necessitated by the claim amendments filed on 12/7/2025.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 12/7/2025, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn with the exception of the rejections based on “substantially planar” in claims 1 and 13.
The Applicant asserts:
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This argument is not persuasive. The specification only uses the term “substantially” once in connection with planar surfaces. Paragraph 0060 of the specification merely states, “The tibial paddle 34 is substantially planar and has a shape generally corresponding to the shape of the orthopaedic prosthesis to be implanted in the patient.” This passage does not describe, explain, or elaborate on which is meant by “substantially”. The figures only show surfaces of the tibial paddle as being planar such that the figures do not describe, explain, or elaborate on what is meant to be “substantially planar” as opposed to simply “planar”. The Applicant’s suggestion that “substantially planar” describes an item that is flat within manufacturing tolerances is not supported explicitly in the specification. It is also not supported implicitly either. For example, other uses for the term “substantial” are used in the specification as follows:
in paragraph 0008 (“the method may include establishing a substantially rectangular gap between the patient’s proximal tibia and a distal femur.”);
in paragraph 0010 (“distracting the patient’s knee joint to establish a substantially rectangular gap between the patient’s proximal tibia and distal femur”);
in paragraph 0013 (“distracting the patient’s knee joint to establish a substantially rectangular gap between the patient’s proximal tibia and distal femur.”);
in paragraph 0063 (“the handle 32 and tibial paddle 34 are substantially monolithic in structure.”); and
in paragraph 0092 (“the paddle 272 has a substantially curricular shape”1).
In these cases, the use of the term “substantially” to mean “within manufacturing tolerances” appears to not have been intended or likely. As such, “substantially” clearly means something more than that.2 If “substantially” means something other than just within manufacturing tolerances, the metes and bounds of the term “substantially planar” cannot be ascertained, thus rendering the expression indefinite.
There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, that were necessitated by the claim amendments filed on 12/7/2025.
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph
In view of the claim amendments filed on 12/7/2025, the previous claim rejections under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, are withdrawn.
Prior art Rejections
With respect to the rejection of claim 1, the Applicant asserts:
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This argument is not persuasive. The combination teaches or suggests the steps of performing a balancing procedure on the patient’s knee joint to achieve a target joint force balance between the patient’s tibia and the patient’s femur in the form of the initial procedure of balancing which results in a joint force balance. The joint force balance of this initial procedure is considered the initial target (col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher). The combination also teaches the step of performing another balancing procedure on the patient’s knee joint to improve the matching of the present joint force balance to the target joint force balance as indicated by the display of the display instrument in the form of the later iterations of balancing that lead to the adjustments and improvements that are made based on the display of force balance data during the movements (col. 6, line 40 to col.8, line 46; FIGS. 8-12 of Amirouche; paragraphs 0020, 0028, and 0074 of Fisher; FIG. 8 of Fisher). The claimed balancing procedures are not limited to any particular steps of movements, but merely require iterations of balancing actions: both initial balancing actions and subsequent ones after adjustments and improvements.
In view of the above, Amirouche and Fisher teach or suggest every feature of claim 1.
With respect to the rejection of claim 13, the Applicant asserts:
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This argument is not persuasive. First, claim 13 does not require that the paddles of the joint distractor contact the planar upper surface of the upper housing.3 Claim 13 only requires that “the joint distractor contact[s] the upper housing of the tibial paddle”. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, the combination teaches or suggests a tibial paddle including an upper housing (the adaptor plate 414 suggested by Fisher) having a substantially planar upper surface and a lower housing (the tibial tray 58 of Amirouche). Merely relying on the teachings of Amirouche is not commensurate with the rejection which is a combination of Amirouche, Fisher, Johanson, and Bonutti. In response to the 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).
Third, the combination teaches or suggests the step of positioning a joint distractor in the patient’s knee joint such that a medial tibial paddle and a lateral tibial paddle of the joint distractor contact the upper housing of the tibial paddle in the form of positioning the joint distractor of Bonutti for joint distraction directly or indirectly in contact with the adaptor plate 414 suggested by Fisher during the assessment of knee alignment or stability.
In view of the above, Amirouche, Fisher, Johanson, and Bonutti teach or suggest every feature of claim 13.
Claims 2-12 are properly rejected since claim 1 is properly rejected and the prior art teaches or suggests all the features of these claims.
Claims 14-19 are properly rejected since claim 13 is properly rejected and the prior art teaches or suggests all the features of these claims.
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 MATTHEW KREMER whose telephone number is (571)270-3394. The examiner can normally be reached Monday - Friday 8 am to 6 pm; every other Friday off.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
1 The Examiner is presuming “curricular” is meant to be “circular”.
2 It is noted that “substantially” is used elsewhere in the specification including “a substantially circular pattern” in paragraph 0071, “substantially ‘cup’-shaped” in paragraph 0090, “a substantial oval shape” in paragraph 0093, “a substantially circular shape” in paragraph 0115, “a substantially parallel orientation” in paragraph 0116, “substantially parallel to each other” in paragraph 0116, and “substantially parallel to the tibial cut” in paragraph 0135. However, these shapes and orientations are not shown to deviate from a circular pattern in paragraph 0071, “cup”-shaped in paragraph 0090, an oval shape in paragraph 0093, a circular shape in paragraph 0115, a parallel orientation in paragraph 0116, parallel to each other in paragraph 0116, and parallel to the tibial cut in paragraph 0135 so as to inform one of ordinary skill in the art what is meant by the term “substantial”.
3 The Applicant’s arguments use the phrase “as recited in independent claim 1”, but the overall paragraph is clearly referring to claim 13.