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 .
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
The abstract of the disclosure is objected to because it contains greater than the 150 word limit. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 24 objected to because of the following informalities:
Claim 24 line 2 should remove the comma “,” after “wherein”.
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 19-22, 25-26, and 28-31 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 19 lines 6-7 recite “a first joint coordinate system” and “a second joint coordinate system”. This creates confusion as to the relationship to “a first joint coordinate system” and “a second joint coordinate system” from claim 15 lines 14-15. If they are the same, the examiner recommends amending claim 19 to recite “the first joint coordinate system” and “the second joint coordinate system”. If they are different, the examiner recommends changing the language to distinguish from “a first joint coordinate system” and “a second joint coordinate system” from claim 15. Claims 20-22 are rejected due to their dependence upon rejected claim 19.
Claim 25 lines 6-7 recite a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)). Claim 26 is rejected due to its dependence upon claim 25.
Claim 28 lines 18-19 recites “standardizing the progression of the kinematics angles through adjustment of the first joint coordinate system and the second joint coordinate system by the first rotation vector and the second rotation vector, respectively”, which creates confusion as “the second rotation vector” is previously recited as an optional component by the use of “and/or” [see claim 28 line 12]. Thus, the claim is indefinite as it is unclear whether the intention is for the second rotation vector is intended to be optionally included or not. For purposes of compact prosecution, the examiner is interpreting the “second rotation vector” to not be optional. Claims 29-31 are rejected due to their dependence upon rejected claim 28.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 15-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 15 recites:
A standard kinematics evaluation system for acquiring, standardizing and evaluating biomechanical kinematics data of a joint of a patient, the standard kinematics evaluation system comprising:
at least one acquisition device adapted to acquire a biomechanical kinematics of the joint with a sensor system and to provide the biomechanical kinematics of the joint in a computer- readable manner;
a visual display device for visual output to a user;
a control unit;
a standardization unit; and
an evaluation unit, the control unit adapted to:
process the biomechanical kinematics of the joint and calculate at least one progression of at least one kinematics angle and/or of at least one kinematics translation of the joint with respect to a first joint element having a first joint coordinate system and with respect to a second joint element having a second joint coordinate system,
determine, via the standardization unit, a rotation vector or a rotation matrix for adjusting an orientation of the first joint coordinate system, and/or determine a rotation vector or a rotation matrix for adjusting an orientation of the second joint coordinate system via a predetermined target optimization in order to perform a standardization, and/or determine a translation vector for adjustment of a position of the first joint coordinate system and/or determine a translation vector for adjustment of a position of the second joint coordinate system via a predetermined target optimization in order to perform a standardization, and
perform, via the evaluation unit, an evaluation with regard to the joint for at least one predefined evaluation parameter based on a standardized kinematics angle and/or a standardized kinematics translation as motion data, and output the evaluation via the visual display device.
Independent claim 28 recites:
A standard kinematics evaluation method for acquiring, standardizing and evaluating biomechanical kinematics data of a joint of a patient, the standard kinematics evaluation method comprising the steps of:
acquiring biomechanical kinematics of the joint of the patient with a sensor system of an acquisition device;
determining, by a control unit, based on the biomechanical kinematics of the joint, a progression of kinematics angles and/or kinematics translations of the joint relative to a first joint element with a first joint coordinate system, and a second joint element with a second joint coordinate system;
determining, by a standardization unit of the control unit, via a predetermined target optimization, a first rotation vector or a first rotation matrix for adjustment of an orientation of the first joint coordinate system and/or a second rotation vector or a second rotation matrix for adjustment of an orientation of the second joint coordinate system, and/or determining, via the predetermined target optimization, a first translation vector for adjustment of a position of the first joint coordinate system and/or determining a second translation vector for adjustment of a position of the second joint coordinate system;
standardizing the progression of the kinematics angles through adjustment of the first joint coordinate system and the second joint coordinate system by the first rotation vector and the second rotation vector, respectively, or the first rotation matrix and the second rotation matrix, respectively, and/or of the progression of the kinematics translations through adjustment of the first joint coordinate system and the second joint coordinate system by the first rotation vector and the second rotation vector, respectively;
performing an evaluation of the joint with respect to a predefined evaluation parameter based on standardized kinematics angles and/or standardized kinematics translations; and
outputting the evaluation with a display device.
Step 1:
The examiner finds claim 15 drawn to a machine and 28 drawn to a method.
Step 2A Prong 1:
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018).
The claimed steps of determining, evaluating, and standardizing recite a mental processes capable of being performed in the human mind and/or mathematical concepts.
The steps of “determining” rotation vectors and progression of kinematic angles in independent Claims 15 and 28 are mental processes capable of being performed in the human mind. For example, the human mind is capable of providing a general determination of angles, such as by recognizing that angles that are formed by approximately perpendicular lines are approximately 90 degrees. The steps of “evaluating” a joint in claims 15 and 28 are mental processes capable of being performed in the human mind. For example, the human mind can determine if bones have been dislocated outside of their normal joint location without the use of any external tool. The step of “standardizing” is a mathematical concept that is a transformation that re-expresses data in a uniform, comparable form—most commonly by converting to z-scores—so that differences in scale or units no longer hinder analysis or comparison.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind,
Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind,
University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding the dependent claims 16-27 and 29-31, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 15-31 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for determining, evaluating, and standardizing merely invoke a computer as a tool.
• The data-gathering step (acquiring, measuring) and the data-output step (displaying, outputting) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
• There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computing device that is used as a tool for generating, detecting, assigning, receiving, and informing.
• The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to estimate bio-information.
• The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computing device for generating, detecting, assigning, receiving, and informing. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: control unit, visual display device, standardization unit, evaluation unit, acceleration sensor, gyro sensor, optical recording unit.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
• Applicant’s disclosure regarding the various units fails to .
• Donaldson (US 20130133424 A1) which discloses the use of accelerometers as conventional to acquiring kinematic data [0006];
• Sager (US 20060071934 A1) which discloses the conventional use of optical systems to capture joint rotation [0043];
• Applicant’s Background in the specification; and
• The non-patent literature of record in the application.
The examiner notes that the various “units” disclosed lack specificity that would distinguish the “units” from being or being performed on a general computing device. Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 15-16, 19-20, 27-28, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stein (US 20220022774 A1).
Regarding claim 15, Stein teaches a standard kinematics evaluation system for acquiring, standardizing and evaluating biomechanical kinematics data of a joint of a patient, the standard kinematics evaluation system comprising:
at least one acquisition device [0090 “a sensor system”] adapted to acquire a biomechanical kinematics of the joint with a sensor system and to provide the biomechanical kinematics of the joint in a computer- readable manner [0090 “The kinetic system includes a sensor system that provides quantitative data and feedback that is displayed visually and/or audibly and/or haptically to a surgeon. The kinetic system provides the surgeon real time dynamic data regarding loads in each compartment of the knee, tibio-femoral implant contact and congruency through a full range of motion, and information regarding angular bony cuts and leg alignment”, see also 0095 “A computer, processor, digital signal process coupled to screen 105 can run software programs that use the quantitative measurements from the sensors to visualize the on-going procedure, review measurement data, positions of the muscular-skeletal system…”];
a visual display device for visual output to a user [Fig. 1C Item 105];
a control unit [0095 “processor”];
a standardization unit [Fig. 1C Item 100, see also 0127 “…GUI 100 can indicate a predetermined area range and compare the actual contact points to the predetermined area range”]; and
an evaluation unit [0092 “Parameters can be evaluated relative to orientation, alignment, direction, displacement, or position as well as movement, rotation, or acceleration along an axis or combination of axes by wireless sensing modules or devices positioned on or within a body, instrument, appliance, vehicle, equipment, or other physical system”],
the control unit adapted to:
process the biomechanical kinematics of the joint and calculate at least one progression of at least one kinematics angle [0177 “…positioning a joint to a target flexion value (e.g. a chosen knee bent) as measured by a sensored module…”] and/or of at least one kinematics translation of the joint with respect to a first joint element having a first joint coordinate system and with respect to a second joint element having a second joint coordinate system [0177 “…rotating the joint 5220 between a first point and a second point where the first and second points are on opposing sides of the joint 5220”, see also Fig. 1A],
determine, via the standardization unit, a rotation vector or a rotation matrix for adjusting an orientation of the first joint coordinate system, and/or determine a rotation vector or a rotation matrix for adjusting an orientation of the second joint coordinate system via a predetermined target optimization in order to perform a standardization, and/or determine a translation vector for adjustment of a position of the first joint coordinate system [0112 “…the difference in the leg alignment when compared to the mechanical axis is calculated by subtracting the medial-lateral bone tilt of the distal end of the femur from the medial-lateral bone tilt of the proximal end of the tibia. This difference is listed on the GUI underlying Mech. Axis (e.g. mechanical axis) based on the tibia and femur quantitative measurements”] and/or determine a translation vector for adjustment of a position of the second joint coordinate system via a predetermined target optimization in order to perform a standardization, and
perform, via the evaluation unit, an evaluation with regard to the joint for at least one predefined evaluation parameter based on a standardized kinematics angle and/or a standardized kinematics translation as motion data [0116 “…the measurement can be used to verify that the leg measures within a predetermined range of the mechanical axis”], and output the evaluation via the visual display device [see Fig. 1C].
Regarding claim 16, Stein teaches the standard kinematics evaluation system according to claim 15, wherein the sensor system comprises at least one acceleration sensor [0099 “The measurement device further includes at least one three-axis accelerometer”] and/or one gyro sensor, the at least one acquisition device being attachable to the patient in a region of the joint [0099 “The sensing system can be integrated into a prosthetic component. In the example, the sensored device is an intra-operative trial insert”].
Regarding claim 19, Stein teaches the standard kinematics evaluation system according to claim 15, wherein:
the at least one kinematics angle comprises a kinematics angle of a flexion [0095], a kinematics angle of an adduction [see Fig. 1B], and a kinematics angle of an internal rotation [Fig. 2 Item 230]; and
the standard kinematics evaluation system is adapted to acquire a knee joint with a tibia coordinate system as a first joint coordinate system [see Figs. 2-3] and a femur coordinate system as a second joint coordinate system [see Figs. 2-3] and to determine a progression of the kinematics angle of the flexion [0177 “…positioning a joint to a target flexion value (e.g. a chosen knee bent) as measured by a sensored module…”], the kinematics angle of the adduction see Fig. 1B], and the kinematics angle of the internal rotation [Fig. 2 Item 230].
Regarding claim 20, Stein teaches the standard kinematics evaluation system according to claim 19, wherein the control unit is adapted to output, as an evaluation, a determination of a gait type and/or a selection of a size of a knee endoprosthesis and/or an orientation of a knee endoprosthesis as an evaluation parameter [0101 “The GUI displays the angle of insert 425 relative to vertical and the angle of tibial crest 427”].
Regarding claim 27, Stein teaches the standard kinematics evaluation system according to claim 15, wherein the control unit is adapted to determine kinematics angles based on the biomechanical kinematics of the patient [0112 “…the difference in the leg alignment when compared to the mechanical axis is calculated by subtracting the medial-lateral bone tilt of the distal end of the femur from the medial-lateral bone tilt of the proximal end of the tibia”] and/or calculate kinematics translations.
Regarding claim 28, Stein teaches a standard kinematics evaluation method for acquiring, standardizing and evaluating biomechanical kinematics data of a joint of a patient, the standard kinematics evaluation method comprising the steps of:
acquiring biomechanical kinematics of the joint of the patient [0090 “The kinetic system includes a sensor system that provides quantitative data and feedback that is displayed visually and/or audibly and/or haptically to a surgeon. The kinetic system provides the surgeon real time dynamic data regarding loads in each compartment of the knee, tibio-femoral implant contact and congruency through a full range of motion, and information regarding angular bony cuts and leg alignment”] with a sensor system of an acquisition device [0090 “a sensor system”];
determining, by a control unit [0095 “processor”], based on the biomechanical kinematics of the joint, a progression of kinematics angles and/or kinematics translations of the joint relative to a first joint element with a first joint coordinate system, and a second joint element with a second joint coordinate system [0177 “…rotating the joint 5220 between a first point and a second point where the first and second points are on opposing sides of the joint 5220”, see also Fig. 1A];
determining, by a standardization unit of the control unit, via a predetermined target optimization, a first rotation vector [Fig. 2 Item 230] or a first rotation matrix for adjustment of an orientation of the first joint coordinate system [see Fig. 2] and/or a second rotation vector or a second rotation matrix for adjustment of an orientation of the second joint coordinate system, and/or determining, via the predetermined target optimization, a first translation vector for adjustment of a position of the first joint coordinate system and/or determining a second translation vector for adjustment of a position of the second joint coordinate system;
standardizing the progression of the kinematics angles through adjustment of the first joint coordinate system and the second joint coordinate system by the first rotation vector and the second rotation vector [0013 “The leg in extension 620 is lifted until the sensored insert in the knee joint is at a 45 degree angle or an optimized angle as depicted on the GUI to the surface of the operating table”, see also 0115 “The tilt of the distal end of the femur is incorporated with the previously measured tilt of the measured proximal end of the tibia to output an offset relative to the mechanical axis as depicted in the GUI in 151A and 151B”], respectively, or the first rotation matrix and the second rotation matrix, respectively, and/or of the progression of the kinematics translations through adjustment of the first joint coordinate system and the second joint coordinate system by the first rotation vector and the second rotation vector, respectively;
performing an evaluation of the joint with respect to a predefined evaluation parameter based on standardized kinematics angles and/or standardized kinematics translations [0116 “…the measurement can be used to verify that the leg measures within a predetermined range of the mechanical axis”]; and
outputting the evaluation with a display device [Fig. 1C Item 105].
Regarding claim 31, Stein teaches a computer-readable storage medium comprising instructions [0189 “…a memory (e.g., RAM, hard drive, USB removable memory), and one or more processors (e.g., single processor, RISC, multiply linked processors such as dual processors) to execute one or more programs (e.g., the software system controlling the feedback display) stored in the memory…”] that, when executed by a computer, cause the computer to carry out the standard kinematics evaluation method according to claim 28 [see claim 28 rejection above].
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Stein as applied to claim 15 above, and further in view of Abbot (US 20200035122 A1).
Regarding claim 17, Stein teaches the standard kinematics evaluation system according to claim 15, wherein Stein teaches the “sensors used in the sensor system are not limited to any particular type of sensor” [0163], but fails to explicitly teach the at least one acquisition device includes at least one optical recording unit as the sensor system, the at least one optical recording unit configured to acquire the biomechanical kinematics of the joint of the patient.
Abott teaches the at least one acquisition device includes at least one optical recording unit as the sensor system [0050 “…a kinematic linkage comprising joint sensors, such as potentiometers or optical encoders…”], the at least one optical recording unit configured to acquire the biomechanical kinematics of the joint of the patient [0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and incorporate the teachings of Abbot to include the at least one acquisition device includes at least one optical recording unit as the sensor system, the at least one optical recording unit configured to acquire the biomechanical kinematics of the joint of the patient. Doing so configures the system to use non-invasive sensors that provide improved patient comfort, high precision in 3D motion analysis, and potential for lower-cost and portable designs.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Stein as applied to claim 15 above, and further in view of Wagner (US 20160262685 A1).
Regarding claim 18, Stein teaches the standard kinematics evaluation system according to claim 15, wherein Stein teaches adjusting the angle to a predetermined target [0116], but fails to explicitly teach a minimization of a variance, a standard deviation, a square error and/or a statistical error of a regression of the at least one kinematics angle is determined as a predetermined target optimization.
Wagner teaches using a standard deviation of the at least one kinematics angle is determined [0130 “…body position and/or joint angle (and/or their acceleration, velocity, position, power, and/or other derived metrics (such as average, median, and/or standard deviation of these metrics))…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and incorporate the teachings of Wagner to include using a standard deviation of the at least one kinematics angle is determined. Doing so provides a metric to the system that determines the accuracy of the angle of the joint in relation to the predetermined target.
Claims 21 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Stein as applied to claim 19 and 28 above, and further in view of Harbison (US 20170340390 A1).
Regarding claim 21, Stein teaches the standard kinematics evaluation system according to claim 19, wherein Stein further teaches determining a kinematics angle defined by a predetermined target [0116], but fails to explicitly teach a minimization of a root-mean-square error of the kinematics angle of the adduction and/or of the kinematics angle of the internal rotation is defined as a predetermined target optimization.
Harbison teaches a minimization of a root-mean-square error of rotation is defined as a predetermined target optimization [0072 “Computing system 100 may estimate the combination of rotation and translation using a root mean square point-to-point distance metric minimization technique to align each source point to its match found in the previous matching step…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and incorporate the teachings of Harbison to include a minimization of a root-mean-square error of rotation is defined as a predetermined target optimization. Doing so provides a metric to the system that determines the accuracy of the angle of the joint in relation to the predetermined target.
Regarding claim 29, Stein teaches the standard kinematics evaluation method according to claim 28, wherein:
the joint of the patient is a knee joint [0090 “The kinetic system provides the surgeon real time dynamic data regarding loads in each compartment of the knee…”],
the standard kinematics evaluation method acquires, standardizes and evaluates the knee joint [0091 “The kinetic system is designed to take quantitative measurements of at least the load, position of load, and alignment with the forces being applied to the joint similar to that of a final joint installation”],
determining a kinematic angle of internal rotation of a femur [0112 “…the difference in the leg alignment when compared to the mechanical axis is calculated by subtracting the medial-lateral bone tilt of the distal end of the femur from the medial-lateral bone tilt of the proximal end of the tibia”], and
determine an adjustment of the orientation and/or position [0092 “…several measured parameters or different measurements are used to make a quantitative assessment. Parameters can be evaluated relative to orientation, alignment, direction, displacement, or position as well as movement, rotation, or acceleration along an axis or combination of axes”], but fails to teach a minimization of a root mean square error of a kinematics angle of adduction, and/or of a kinematics angle of internal rotation of a femur is defined.
Harbison teaches a minimization of a root-mean-square error of rotation is defined as a predetermined target optimization [0072 “Computing system 100 may estimate the combination of rotation and translation using a root mean square point-to-point distance metric minimization technique to align each source point to its match found in the previous matching step…”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and incorporate the teachings of Harbison to include a minimization of a root-mean-square error of rotation is defined as a predetermined target optimization. Doing so provides a metric to the system that determines the accuracy of the angle of the joint in relation to the predetermined target.
Claims 22 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Stein as applied to claim 19 and 28 above, and further in view of Cinquin (US 20050113720 A1).
Regarding claim 22, Stein teaches the standard kinematics evaluation system according to claim 19, wherein Stein further teaches determining a kinematics angle defined by a predetermined target [0116], but fails to explicitly teach a minimization of a variance of the kinematics angle of the adduction and/or of the kinematics angle of the internal rotation is defined as a predetermined target optimization.
Cinquin teaches a minimization of a variance of the kinematics angle of the internal rotation is defined as a predetermined target optimization [0062 “Using the variance to characterize the dispersion of the cluster of points, it is possible to apply a minimization method to this variance to obtain the position of the center of rotation”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of eh claimed invention to take the teachings of Stein and incorporate the teachings of Cinquin to include a minimization of a variance of the kinematics angle of the internal rotation is defined as a predetermined target optimization. Doing so provides a metric to the system that determines the accuracy of the angle of the joint in relation to the predetermined target.
Regarding claim 30, Stein teaches the standard kinematics evaluation method according to claim 28, wherein:
the joint of the patient is a knee joint [0090 “The kinetic system provides the surgeon real time dynamic data regarding loads in each compartment of the knee…”],
the standard kinematics evaluation method acquires, standardizes and evaluates the knee joint [0091 “The kinetic system is designed to take quantitative measurements of at least the load, position of load, and alignment with the forces being applied to the joint similar to that of a final joint installation”],
determining a kinematic angle of internal rotation of a femur [0112 “…the difference in the leg alignment when compared to the mechanical axis is calculated by subtracting the medial-lateral bone tilt of the distal end of the femur from the medial-lateral bone tilt of the proximal end of the tibia”], and
determine an adjustment of the orientation and/or position [0092 “…several measured parameters or different measurements are used to make a quantitative assessment. Parameters can be evaluated relative to orientation, alignment, direction, displacement, or position as well as movement, rotation, or acceleration along an axis or combination of axes”], but fails to teach a minimization of a variance of a kinematics angle of adduction, and/or of a kinematics angle of internal rotation of a femur is defined, as the predetermined target optimization.
Cinquin teaches a minimization of a variance of the kinematics angle of the internal rotation is defined as a predetermined target optimization [0062 “Using the variance to characterize the dispersion of the cluster of points, it is possible to apply a minimization method to this variance to obtain the position of the center of rotation”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of eh claimed invention to take the teachings of Stein and incorporate the teachings of Cinquin to include a minimization of a variance of the kinematics angle of the internal rotation is defined as a predetermined target optimization. Doing so provides a metric to the system that determines the accuracy of the angle of the joint in relation to the predetermined target.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Stein as applied to claim 15 above, and further in view of Sankai (US 20120029399 A1).
Regarding claim 23, Stein teaches the standard kinematics evaluation system according to claim 15, wherein Stein teaches the control unit and a storage [0189 “memory”], but fails to explicitly teach the storage unit includes a database with an assignment of standardized kinematics angles to evaluation parameters.
Sankai teaches the storage unit includes a database with an assignment of standardized kinematics angles to evaluation parameters [0227 “…comparing the joint angles detected by the angle sensor 96 and the joint angles stored in the calibration database 400”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and incorporate the teachings of Sankai to include the storage unit includes a database with an assignment of standardized kinematics angles to evaluation parameters. Doing so configures the system to identify “a phase(s) corresponding to the pattern of the calibration movement”, as recognized by Sankai par. 0227.
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Stein and Sankai as applied to claim 23 above, and further in view of de la Barrera (US 20060095047 A1).
Regarding claim 24, Stein and Sankai teach the standard kinematics evaluation system according to claim 23, wherein Sankai teaches the storage unit includes a database with an assignment of standardized kinematics angles to evaluation parameters [Sankai 0227] and Stein teaches a knee endoprosthesis, but fail to explicitly teach the standardized kinematics angles are assigned to a size and an alignment of a knee endoprosthesis.
De la Barrera teaches the standardized kinematics angles are assigned to a size and an alignment of a knee endoprosthesis [0034 “The algorithm used by the system 100 uses the database 143 with all of the implants components and optimizes the above parameters by choosing an appropriate combination of components and respective alignments (e.g., head offset, neck angle, cup orientation) therefor. The implant components in the database 143 can be complete sets of implants of varying sizes as well as modular implants that can be combined by the surgeon to produce a more customizable implant”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and Sankai and incorporate the teachings of de la Barrera to include the standardized kinematics angles are assigned to a size and an alignment of a knee endoprosthesis. Doing so configures the system to allow the surgeon to “produce a more customizable implant”, as recognized by par. 0034, which maximized the effectiveness of the endoprosthesis.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Stein as applied to claim 15 above, and further in view of Morris (US 20210059565 A1).
Regarding claim 25, Stein teaches the standard kinematics evaluation system according to claim 15, wherein Stein teaches using standardized kinematics angles and/or standardized kinematics translations, and an output regarding an endoprosthesis of the joint of the patient, so that the control unit is adapted to output an evaluation for the endoprosthesis when a new biomechanical kinematics of a patient is acquired through standardized kinematics angles and/or standardized kinematics translations [0101], but fails to teach using an artificial intelligence system trained with standardized kinematic angles as inputs and outputs an evaluation when a new biomechanical kinematics of a patient is acquired.
Morris teaches using an artificial intelligence system trained with standardized kinematic angles as inputs and outputs an evaluation when a new biomechanical kinematics of a patient is acquired [0073 “…operating a machine-learning model on the video data of the patient walking to determine three-dimensional joint positions, the machine-learning model having been trained on video training data correlated with ground-truth three-dimensional joint positions; calculating joint angles from the three-dimensional joint positions; and processing the joint angles to derive one or more gait metrics collectively constituting the gait signature”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and incorporate the teachings of Morris to include using an artificial intelligence system trained with standardized kinematic angles as inputs. Doing so configures the system to automate the evaluation process, which provides for a rapid and efficient means of feedback to the user.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Stein and Morris as applied to claim 25 above, and further in view of de la Barrera.
Regarding claim 26, Stein and Morris teach the standard kinematics evaluation system according to claim 25, wherein Stein teaches an evaluation of alignment of an endoprosthesis, but fails to explicitly teach the evaluation comprises a size for the endoprosthesis.
De la Barrera teaches the evaluation comprises a size for the endoprosthesis [0034 “The algorithm used by the system 100 uses the database 143 with all of the implants components and optimizes the above parameters by choosing an appropriate combination of components and respective alignments (e.g., head offset, neck angle, cup orientation) therefor. The implant components in the database 143 can be complete sets of implants of varying sizes as well as modular implants that can be combined by the surgeon to produce a more customizable implant”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of Stein and Morris and incorporate the teachings of de la Barrera to include the evaluation comprises a size for the endoprosthesis. Doing so configures the system to allow the surgeon to “produce a more customizable implant”, as recognized by par. 0034, which maximized the effectiveness of the endoprosthesis.
Conclusion
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/JONATHAN M HANEY/ Examiner, Art Unit 3791
/ALEX M VALVIS/ Supervisory Patent Examiner, Art Unit 3791
