DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. The Applicant’s submission filed on 4/30/2026 has been entered.
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 1 is objected to because of the following informalities:
in claim 1, lines 26-27: “of the upper housing” should be inserted after “the planar upper surface”.
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.
Claim 20 is 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 20 recites “a tibial paddle” in lines 1-2, but it is not clear if this recitation is the same as, related to, or different from “a tibial paddle” of claim 13, line 6. If they are the same, “a tibial paddle” in claim 20 should be “the tibial paddle”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
Claim 20 recites “a sensor module” in line 2, but it is not clear if this recitation is the same as, related to, or different from “a sensor module” of claim 13, line 6. If they are the same, “a sensor module” in claim 20 should be “the sensor module”. If they are different, their relationship should be made clear and they should be clearly distinguished from each other (e.g., when multiple elements have similar or the same labels, distinct identifiers such as “first” and “second” should be used to clearly differentiate the elements).
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 within the elevated surface 72 on the bottom side and the recesses 66 and 68 positioned on its upper surface (FIGS. 4-5 of Amirouche). Fisher discloses that a sensor plate 412 and an adaptor 414 may be separate or integral with each other and/or the combined sensor plate/adapter may be separate or integral with a tibial insert 416 (paragraphs 0069-0070 of Fisher). The combination of the sensor plate 412 and the adaptor 414 of Fisher are comparable to the elevated portion 72 of Amirouche with the embedded sensors 35 of Amirouche. The tibial insert 416 of Fisher is comparable to the components 60, 64, 66, 68, and 70 of the spacer 34 of Amirouche. It would have been obvious to one of ordinary skill in the art at the time of invention to split the elevated portion 72 of Amirouche (comparable to the sensor plate 412 and adaptor 414 of Fisher) from the rest of the spacer 34 (the components 60, 64, 66, 68, and 70 of Amirouche) and to split the elevated portion 72 of Amirouche into a sensor plate portion and an adaptor portion with the sensors located therebetween since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it permits multiple, differently-sized inserts to be tried during a surgical procedure (paragraph 0070 of Fisher).
Fisher discloses a handle protruding from the sensor plate 412 with a pair of displays so as to provide pressures 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 the elevated portion 72 of Amirouche, the handle having a pair of displays showing pressures 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 (the resection is shown in 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 (the separated elevated portion 72 of Amirouche) on the resected surface of the patient’s tibia, the tibial paddle having an upper housing (the adaptor portion of the separated elevated portion 72 of Amirouche) with a planar upper surface and a lower housing (the sensor plate portion of the separated elevated portion 72 of Amirouche) opposite from and coupled to the upper housing, wherein the tibial paddle includes a sensor array (the plurality of sensors 35 contained between the sensor plate and adaptor portions of the separate portion 72 of Amirouche) located between a portion of the lower housing and a corresponding portion of the upper housing that is spaced apart from the portion of the lower housing such that the sensor array is compressed therebetween, the sensor array 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 (the display; 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), wherein positioning includes moving the upper housing, the lower housing, and the sensor array simultaneously into the patient’s knee joint (paragraphs 0069-0070 of Fisher teaches that the sensor plate and adaptor portions can be integral or attached by adhesive or welding (which connotes or suggests a pre-assembly of the sensor plate portion, the adaptor portion, and the sensor array before installation). Also, the installation in the patient includes two alternatives (simultaneous installation of the pre-assembled components or sequential installation of the separated components). It would have been obvious for one of ordinary skill in the art to pursue the known potential solutions with a reasonable expectation of success and/or it would have been obvious for one of ordinary skill in the art to pre-assemble the sensor plate portion, the adaptor portion, and the sensor array before installation since it provides a better view of the assembly to ensure proper assembly before testing and/or simplifies the installation process),
separate from positioning the tibial paddle of the sensor module, placing a tibial trial bearing (the components 60, 64, 66, 68, and 70 of the spacer 34 of Amirouche) on the planar upper surface of the upper housing (the adaptor portion of the separated elevated portion 72 of Amirouche) 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 planar bottom surface that confronts and contacts the 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 sensors 35 below the recesses 66 and 68 of Amirouche).
With respect to claim 8, the combination teaches or suggests 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 pressures 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 pressures 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 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 13-20 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), and further in view of U.S. Patent Application Publication No. 2008/0161815 (Schoenefeld).
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 within the elevated surface 72 on the bottom side and the recesses 66 and 68 positioned on its upper surface (FIGS. 4-5 of Amirouche). Fisher discloses that a sensor plate 412 and an adaptor 414 may be separate or integral with each other and/or the combined sensor plate/adapter may be separate or integral with the tibial insert 416 (paragraphs 0069-0070 of Fisher). The combination of the sensor plate 412 and the adaptor 414 of Fisher are comparable to the elevated portion 72 of Amirouche with the embedded sensors 35 of Amirouche. The tibial insert 416 of Fisher is comparable to the components 60, 64, 66, 68, and 70 of the spacer 34 of Amirouche. It would have been obvious to one of ordinary skill in the art at the time of invention to split the elevated portion 72 (comparable to the sensor plate 412 and adaptor 414 of Fisher) from the rest of the spacer 34 (the components 60, 64, 66, 68, and 70 of Amirouche) and to split the elevated portion 72 of Amirouche into a sensor plate portion and an adaptor portion with the sensors located therebetween since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it permits multiple, differently-sized inserts to be tried during a surgical procedure (paragraph 0070 of Fisher).
Fisher discloses a handle protruding from the sensor plate 412 with a pair of displays so as to provide pressures 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 the elevated portion 72 of Amirouche, the handle having a pair of displays showing pressures 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.
As to placement of the joint distractor, there are two alternatives (the placement between the separated elevated portion 72 and the tibial tray 58 or the placement between the adaptor portion of the separated elevated portion 72 of Amirouche and the rest of the spacer 34 (components 60, 64, 66, 68, and 70) of Amirouche). The reasons are the placement of the joint distractor between the adaptor and sensor plate portions of the separate elevated portion would interfere with the housing of the sensors contained therebetween and the placement of the joint distractor on top of the spacer 34 would interfere with the interactions between the condyle recesses 66 and 68 and the femoral component 32 of Amirouche. Also, Schoenefeld teaches that placing adjustment paddles under the femoral engagement components and above the tibial tray 1308 reduces the need to align the device relative to the mechanical axis (paragraphs 0077-0078 and 0108-0111 of Schoenefeld and FIGS. 26-28 Schoenefeld). It would have been obvious for one of ordinary skill in the art to pursue the known potential solutions, using the teachings of Schoenefeld as a guide, with a reasonable expectation of success and/or it would have been obvious for one of ordinary skill in the art to place the joint distractor toward the middle of the joint under the femoral engagement components and above the tibial tray to inhibit skewing of the joint during distraction (i.e., maintaining alignment with the mechanical axis) since the center of the joint is a more stable location relative to off center.
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 (the resection is shown in FIG. 3 of Amirouche),
positioning a tibial paddle of a sensor module (the separated elevated portion 72 of Amirouche) on the resected surface of the patient’s tibia, the tibial paddle including an upper housing (the adaptor portion of the separated elevated portion 72 of Amirouche) having a planar upper surface and a lower housing (the sensor plate portion of the separated elevated portion 72 of Amirouche) opposite from and coupled to the upper housing, wherein the tibial paddle includes a sensor array (the plurality of sensors 35 contained between the sensor plate and adaptor portions of the separate portion 72 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 directly contact the planar upper surface of the upper housing of the tibial paddle (positioning the joint distractor of Bonutti for joint distraction during the assessment of knee alignment or stability; See the 103 rejection regarding the placement of the joint distractor),
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 on the planar upper surface of the upper housing (the adaptor portion of the separated elevated portion 72 of Amirouche) 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 array 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 a 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 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).
With respect to claim 20, paragraphs 0069-0070 of Fisher teaches that the sensor plate and adaptor portions can be integral or attached by adhesive or welding (which connotes or suggests a pre-assembly of the sensor plate portion, the adaptor portion, and the sensor array before installation). Also, the installation in the patient includes two alternatives (simultaneous installation of the pre-assembled components or sequential installation of the separated components). It would have been obvious for one of ordinary skill in the art to pursue the known potential solutions with a reasonable expectation of success and/or it would have been obvious for one of ordinary skill in the art to pre-assemble the sensor plate portion, the adaptor portion, and the sensor array before installation since it provides a better view of the assembly to ensure proper assembly before testing and/or simplifies the installation process. Thus, the combination teaches or suggests that positioning a tibial paddle of a sensor module on the resected surface of the patient’s tibia includes moving the upper housing, the lower housing, and the sensor array simultaneously into the patient’s knee joint.
Response to Arguments
The Applicant’s arguments filed on 4/30/2026 have been fully considered.
Claim objections
In view of the claim amendments filed on 4/30/2026, the previous claim objections are withdrawn. There are new grounds of claim objections.
35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
In view of the claim amendments filed on 4/30/2026, the previous claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, are withdrawn. There are new grounds of claim rejections under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph.
Prior art Rejections
The rejection based on Amirouche and Fisher has been changed to such an extent that it constitutes new grounds of rejection, thus rendering the Applicant’s arguments moot. However, the Examiner makes the following comments.
With respect to the rejection of claim 1, the Applicant asserts:
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These arguments are not persuasive since the grounds of rejection have changed. Fisher discloses that the sensor plate 412 and the adaptor 414 may be separate or integral with each other and/or the combined sensor plate/adapter may be separate or integral with the tibial insert 416 (paragraphs 0069-0070 of Fisher). The combination of the sensor plate 412 and the adaptor 414 of Fisher are comparable to the elevated portion 72 of Amirouche with the embedded sensors 35 of Amirouche. The tibial insert 416 of Fisher is comparable to the components 60, 64, 66, 68, and 70 of the spacer 34 of Amirouche. It would have been obvious to one of ordinary skill in the art at the time of invention to split the elevated portion 72 (comparable to the sensor plate 412 and adaptor 414 of Fisher) from the rest of the spacer 34 (the components 60, 64, 66, 68, and 70 of Amirouche) and to split the elevated portion 72 of Amirouche into a sensor plate portion and an adaptor portion with the sensors located therebetween since (1) it is a simple substitution of one known element for another to obtain predictable results and/or (2) it permits multiple, differently-sized inserts to be tried during a surgical procedure (paragraph 0070 of Fisher).
Thus, the combination teaches or suggests a tibial paddle of a sensor module (the separated elevated portion 72 of Amirouche) on the resected surface of the patient’s tibia, the tibial paddle having an upper housing (the adaptor portion of the separated elevated portion 72 of Amirouche) with a planar upper surface and a lower housing (the sensor plate portion of the separated elevated portion 72 of Amirouche) opposite from and coupled to the upper housing, wherein the tibial paddle includes a sensor array (the plurality of sensors 35 contained between the sensor plate and adaptor portions of the separate portion 72 of Amirouche) located between a portion of the lower housing and a corresponding portion of the upper housing that is spaced apart from the portion of the lower housing such that the sensor array is compressed therebetween.
The Applicant asserts:
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649
1038
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This argument is not persuasive. Paragraphs 0069-0070 of Fisher teaches that the sensor plate and adaptor portions can be integral or attached by adhesive or welding (which connotes or suggests a pre-assembly of the sensor plate portion, the adaptor portion, and the sensor array before installation). Also, the installation in the patient includes two alternatives (simultaneous installation of the pre-assembled components or sequential installation of the separated components). It would have been obvious for one of ordinary skill in the art to pursue the known potential solutions with a reasonable expectation of success and/or it would have been obvious for one of ordinary skill in the art to pre-assemble the sensor plate portion, the adaptor portion, and the sensor array before installation since it provides a better view of the assembly to ensure proper assembly before testing and/or simplifies the installation process. Thus, the combination teaches or suggests that positioning includes moving the upper housing, the lower housing, and the sensor array simultaneously into the patient’s knee joint.
For at least the above reasons, the rejection of claim 1 is proper. Claims 2-12 are proper because the rejection of claim 1 is proper and the prior art teaches or suggests the features of these claims.
With respect to the rejection of claim 13, the combination of Amirouche and Fisher teaches the upper housing, lower housing, and sensor array in the same manner as the combination of Amirouche and Fisher teaches the upper housing, lower housing, and sensor array of claim 1.
The Applicant asserts:
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418
1032
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533
1012
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These arguments are not persuasive since they do not address the combination of these two references. 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).
The Applicant asserts:
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765
1033
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117
1024
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This argument is not persuasive since there are new grounds of rejection.
The Applicant asserts:
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237
1024
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This argument is not persuasive since Amirouche teaches balancing with extensions and Bonutti teaches the joint distractor used for distraction.
In view of the above, Amirouche, Fisher, Johanson, and Bonutti teach or suggest every feature of claim 13.
Claims 14-20 are properly rejected since claim 13 is properly rejected and the prior art teaches or suggests all the features of these claims.
Conclusion
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JACQUELINE CHENG can be reached at (571) 272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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