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 .
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14 is recited twice in the claim, although one has been canceled it is improper for Claim 14 to both have the identifier of being canceled and active. Claim 14 should instead be entirely canceled while a new claim with a new number takes the dependent claim position.
Appropriate correction is required.
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 1-20, are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims 1-9 & 16-20 recites A computer-implemented method for generating and presenting a display of a visualization of joint parameters, the method comprising: extracting, by one or more processors, gap parameter information of a joint of a patient, the gap parameter information including at least a first gap measurement and a second gap measurement, calculating, based on the gap parameter information, delta parameter information, wherein the delta parameter information is calculated at least in part based on a difference between the first gap measurement and the second gap measurement; generating, by the one or more processors, a graphical user interface (GUI) based on the delta parameter information, wherein the GUI includes a three-dimensional element configured to represent the delta parameter information; and displaying, by the one or more processors, the generated GUI on an electronic display;
Claims 10-15 recites a system for generating and presenting a display of a visualization of joint parameters, comprising: a computer-readable storage medium storing instructions for generating and presenting a display of guidance for performing a medical procedure; and one or more processors configured to execute the instructions to perform a method including: receiving acquiring imaging data of a joint generated by a medical imaging system; determining gap parameter information based on the imaging data, the gap parameter information including at least a first gap measurement and a second gap measurement, calculating, based on the gap parameter information, delta parameter information, wherein the delta parameter information is calculated at least in part based on a difference between the first gap measurement and the second gap measurement; generating a graphical user interface (GUI) configured to display a three-dimensional element comprising a plurality of sub-elements; determining which of the plurality of sub-elements correspond to the determined gap delta parameter information; and generating a display of the GUI, wherein at least one sub-element is associated with the determined gap delta parameter information.
Which as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but presumable recitation of generic computer components.
That is, other than presumably reciting “one or more processors”, “graphical user interface (GUI)”, and an “electronic display”, nothing in the claim element precludes the step from practically being performed in the mind. For example “extracting, by one or more processors, gap parameter information of a joint of a patient, the gap parameter information including at least a first gap measurement and a second gap measurement,” in the context of this claim encompasses a data gathering step which can be done by the user. The user could manually also “calculating, based on the gap parameter information, delta parameter information, wherein the delta parameter information is calculated at least in part based on a difference between the first gap measurement and the second gap measurement” by using pen and paper with the data provided from the previous step as well as “generating, by the one or more processors, a graphical user interface (GUI) based on the delta parameter information, wherein the GUI includes a three-dimensional element configured to represent the delta parameter information.”
If a claim limitation, under its broadest reasonable interpretation, covers performance of the imitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. The judicial exception is not integrated into a practical application. In particular, the claim only recites three additional element – using a processor, graphical user interface (GUI), and an electronic display to perform the above noted steps. The processor is recited at a high-level of generality (i.e., as a generic processor conducting basic processing functions) such that it amounts no more than mere instructions to apply the exception using a processor. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly
more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using an electronic display to perform the displaying steps amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
The claims are not patent eligible.
As for the depending claim(s), they are also rejected under 35 USC 101 at least for the similar
reasons noted above as they are directed to abstract ideas and does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Therefore, the claims are not patent eligible.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 10-13, & 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Merette et al (US20220183774A1;hereinafter referred to as Merette) in view of Branch et al (US20200289064A1; hereinafter referred to as Branch).
Regarding Claim 1, Merette discloses a computer-implemented method for generating and presenting a display of a visualization of joint parameters (“A system may include a display device and a computing device including a memory device with instructions. The instructions can cause the system to access surgical data, calculate medial and lateral gap data, calculate a recommended component set, and generate a graphical user interface.” [Abstract]), the method comprising:
extracting, by one or more processors, gap parameter information of a joint of a patient, the gap parameter information including at least a first gap measurement and a second gap measurement (“the technique 1200 can include operations such as accessing surgical data at 1202, calculating gaps at 1204, determining components at 1206, generating the GUI at 1208… The soft-tissue data can include actual measurements of tension in a medial and a lateral side of joint. The soft-tissue data can also (or alternatively) include gap distance measurements taken” [0070]),
calculating, based on the gap parameter information, delta parameter information, wherein the delta parameter information is calculated at least in part based on a difference between the first gap measurement and the second gap measurement (“FIG. 11E illustrates another example soft-tissue section including a variation on the trapezoidal graphic. In this example, trapezoidal graphic 430E can include balance angle indicator 431E, joint gap indicator 432E, resection angle indicator 433E, lateral overlap indicator 438E and medial overlap indicator 439E, The lateral overlap indicator 438E and the medial overlap indicator 439E in this example are angled to coincide with the resection angle indicator 433D and a graphical representation of the posterior portions of the medial and lateral condyles is also included in the distal femur graphic 426. Also in this example, the medial laxity indicator 434E and the lateral laxity indicator 435E include Loose/Neutral/Tight indicators as well as total laxity measurements and measures of tightness or looseness.” [0069];
generating, by the one or more processors, a graphical user interface (GUI) based on the delta parameter information (“the technique 1200 can include operations such as accessing surgical data at 1202, calculating gaps at 1204, determining components at 1206, generating the GUI at 1208” [0070]);
and displaying, by the one or more processors, the generated GUI on an electronic display (“the method can include operations such as accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface, and outputting the graphical user interface to the display device.“ [0086]).
Merette does not specifically teach that the GUI includes a three-dimensional element configured to represent the delta parameter information.
However, in a similar field of endeavor, Branch teaches A method of evaluating a joint includes generating visualization data for a three-dimensional representation of the joint to be rendered via a display [Abstract].
Branch also teaches that the GUI includes a three-dimensional element configured to represent the delta parameter information (“The modeling instructions 228 may also cause the processor 220 to incorporate one or more planes into the three-dimensional representations. In those cases, the processor 220 is further configured through the execution of the modeling instructions 228 to generate plane data for a representation of each plane to be rendered via the display with the three-dimensional representation of the joint. Each plane has a position and an orientation fixed relative to a bone of the joint. The plane moves with the bone movement. The orientation of the plane also changes as the bone reorients. The plane(s) may thus facilitate observation of the joint movement, which may be relatively small in scale. In this way, the depiction of the plane(s) allows the movement to be depicted in scale.” [0048], “The depiction of the planes may facilitate other aspects of the three-dimensional representation of the movement. For instance, the color (or other characteristic) of the plane(s) may be modified to indicate a certain circumstance or condition… Alternatively or additionally, the color or other characteristic of a plane may be modified to indicate that the position of the bone has exceeded a range, such as a normative range.” [0049])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Merette as outlined above with the GUI includes a three-dimensional element configured to represent the delta parameter information as taught by Branch, because it may improve the visualization, interpretation, and evaluation of the test data, as well as the evaluation of the joint [0019].
Regarding Claim 2, Merette discloses that the gap parameter information includes a first gap parameter value, a second gap parameter value, a third gap parameter value, and a fourth gap parameter value (“The laxity scales will be different in flexion and extension. The laxity scales could be provided throughout all angles of flexion.” [0054], “In this example, the soft-tissue section 425B includes trapezoidal graphic 430B, medial laxity indicator 434B, lateral laxity indicator 435B, medial gap data 436B, and lateral gap data 437B. In this example, the trapezoidal graphic 430B includes joint gap indicator 432B, balance angle indicator 4318 and resection angle indicator 433B as well as a textual display indicating the common gap distance across both medial and lateral side of the joint (19.0 mm in this example). The medial gap data 436 and lateral gap data 437B both include information such as Total Gap and Cut measurements. The medial laxity indicator 434B and the lateral laxity indicator 435B both include readouts indicating actual laxity measurement in addition to the Loose, Normal, or Tight indictors,” [0066]).
Regarding Claim 3, Lang discloses that the delta parameter information includes a first delta parameter value, a second delta parameter value, and a third delta parameter value (“the trapezoidal graphic 430C can include a joint gap indicator 432C, medial overlap indicator 439C and lateral overlap indicator 438C. The medial overlap indicator 439C provides a linear graphical display of the medial condyle overlap into the projected posterior femoral resection. In this example, the angle of the resection is not depicted, but rather a bar-graph type view of the overlaps of the condyles is shown instead. The lateral overlap indicator 438C depicts the lateral condyle overlap. The hashed portion of the medial overlap indicator 439C and lateral overlap indicator 438C illustrate the amount of laxity on each side of the joint illustrated in conjunction with the condyle overlap to assist in putting the laxity measurements into perspective in view of the planned resections.” [0067]).
Regarding Claim 4, Lang discloses that the three-dimensional element comprises a plurality of sub-elements, each of the plurality of sub-elements corresponding to a pre-determined first delta parameter value, a pre-determined second delta parameter value, and a pre-determined third delta parameter value (“the trapezoidal graphic 430C can include a joint gap indicator 432C, medial overlap indicator 439C and lateral overlap indicator 438C. The medial overlap indicator 439C provides a linear graphical display of the medial condyle overlap into the projected posterior femoral resection. In this example, the angle of the resection is not depicted, but rather a bar-graph type view of the overlaps of the condyles is shown instead. The lateral overlap indicator 438C depicts the lateral condyle overlap. The hashed portion of the medial overlap indicator 439C and lateral overlap indicator 438C illustrate the amount of laxity on each side of the joint illustrated in conjunction with the condyle overlap to assist in putting the laxity measurements into perspective in view of the planned resections.” [0067]).
Regarding Claim 5, Lang discloses that calculating the delta parameter information comprises: calculating a first difference between the first gap parameter value and the second gap parameter value; calculating a second difference between the first gap parameter value and the third gap parameter value; and calculating a third difference between the first gap parameter value and the fourth gap parameter value (“The operations performed by the computing device can include accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface, and outputting the graphical user interface to the display device. In this example, the surgical data can include soft tissue data indicative of at least, tension in soft tissues surrounding a surgical location. Calculating a medial total gap and a lateral total gap is based at least in part on the soft tissue data. The component set is recommended based at least in part on the medial total gap and lateral total gap. The graphical user interface includes an interactive trapezoidal graphic overlaid onto a graphical representation of a distal femur and a proximal tibia. The interactive trapezoidal graphic can include a graphical representation of the medial total gap, the lateral total gap, and at least a portion of the recommended component set.” [0075]).
Regarding Claim 6, Lang discloses that calculating the delta parameter information further comprises: determining the first delta parameter value based on the first difference; determining the second delta parameter value based on the second difference; and determining the third delta parameter value based on the third difference (“The operations performed by the computing device can include accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface, and outputting the graphical user interface to the display device. In this example, the surgical data can include soft tissue data indicative of at least, tension in soft tissues surrounding a surgical location. Calculating a medial total gap and a lateral total gap is based at least in part on the soft tissue data. The component set is recommended based at least in part on the medial total gap and lateral total gap. The graphical user interface includes an interactive trapezoidal graphic overlaid onto a graphical representation of a distal femur and a proximal tibia. The interactive trapezoidal graphic can include a graphical representation of the medial total gap, the lateral total gap, and at least a portion of the recommended component set.” [0075]).
Regarding Claim 7, Lang discloses that the first gap parameter value is a measure of a medial extension gap in a knee joint of a patient; the second gap parameter value is a measure of a lateral extension gap in the knee joint of the patient; the third gap parameter value is a measure of a medial flexion gap in the knee joint of the patient; and the fourth gap parameter value is a measure of a lateral flexion gap in the knee joint of the patient (“the soft-tissue section 425B includes trapezoidal graphic 430B, medial laxity indicator 434B, lateral laxity indicator 435B, medial gap data 436B, and lateral gap data 437B. In this example, the trapezoidal graphic 430B includes joint gap indicator 432B, balance angle indicator 4318 and resection angle indicator 433B as well as a textual display indicating the common gap distance across both medial and lateral side of the joint (19.0 mm in this example). The medial gap data 436 and lateral gap data 437B both include information such as Total Gap and Cut measurements. The medial laxity indicator 434B and the lateral laxity indicator 435B both include readouts indicating actual laxity measurement in addition to the Loose, Normal, or Tight indictors.” [0066]).
Regarding Claim 10, Merette discloses system for generating and presenting a display of a visualization of joint parameters, comprising: a computer-readable storage medium storing instructions for generating and presenting a display of guidance for performing a medical procedure; and one or more processors configured to execute the instructions (“A system may include a display device and a computing device including a memory device with instructions. The instructions can cause the system to access surgical data, calculate medial and lateral gap data, calculate a recommended component set, and generate a graphical user interface.” [Abstract], “The computing device can also include a processor coupled to a memory device, with the memory device including instructions that, when executed by the processor, cause the computing device to perform operations. The operations performed by the computing device can include accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface” [0075]) to perform a method including:
acquiring imaging data of a joint generated by a medical imaging system; determining gap parameter information based on the imaging data, the gap parameter information including at least a first gap measurement and a second gap measurement (“the implant assessment 54 may include the bone models B from pre-operative imaging (e.g., MRI, CT-scans, 2D X-ray to 3D), whether in 3D or in multiple 2D views.” [0028], “the technique 1200 can include operations such as accessing surgical data at 1202, calculating gaps at 1204, determining components at 1206, generating the GUI at 1208… The soft-tissue data can include actual measurements of tension in a medial and a lateral side of joint. The soft-tissue data can also (or alternatively) include gap distance measurements taken” [0070]),
calculating, based on the gap parameter information, delta parameter information, wherein the delta parameter information is calculated at least in part based on a difference between the first gap measurement and the second gap measurement (“FIG. 11E illustrates another example soft-tissue section including a variation on the trapezoidal graphic. In this example, trapezoidal graphic 430E can include balance angle indicator 431E, joint gap indicator 432E, resection angle indicator 433E, lateral overlap indicator 438E and medial overlap indicator 439E, The lateral overlap indicator 438E and the medial overlap indicator 439E in this example are angled to coincide with the resection angle indicator 433D and a graphical representation of the posterior portions of the medial and lateral condyles is also included in the distal femur graphic 426. Also in this example, the medial laxity indicator 434E and the lateral laxity indicator 435E include Loose/Neutral/Tight indicators as well as total laxity measurements and measures of tightness or looseness.” [0069];
generating a graphical user interface (GUI) configured to display a three-dimensional element comprising a plurality of sub-elements; determining which of the plurality of sub-elements correspond to the determined delta parameter information; and generating a display of the GUI, wherein at least one sub-element is associated with the determined delta parameter information (““the trapezoidal graphic 430C can include a joint gap indicator 432C, medial overlap indicator 439C and lateral overlap indicator 438C. The medial overlap indicator 439C provides a linear graphical display of the medial condyle overlap into the projected posterior femoral resection. In this example, the angle of the resection is not depicted, but rather a bar-graph type view of the overlaps of the condyles is shown instead. The lateral overlap indicator 438C depicts the lateral condyle overlap. The hashed portion of the medial overlap indicator 439C and lateral overlap indicator 438C illustrate the amount of laxity on each side of the joint illustrated in conjunction with the condyle overlap to assist in putting the laxity measurements into perspective in view of the planned resections.” [0067], “the technique 1200 can include operations such as accessing surgical data at 1202, calculating gaps at 1204, determining components at 1206, generating the GUI at 1208” [0070], “the method can include operations such as accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface, and outputting the graphical user interface to the display device.“ [0086]).
Merette does not specifically teach that the GUI includes a three-dimensional element configured to represent the delta parameter information.
However, in a similar field of endeavor, Branch teaches A method of evaluating a joint includes generating visualization data for a three-dimensional representation of the joint to be rendered via a display [Abstract].
Branch also teaches that the GUI includes a three-dimensional element configured to represent the delta parameter information (“The modeling instructions 228 may also cause the processor 220 to incorporate one or more planes into the three-dimensional representations. In those cases, the processor 220 is further configured through the execution of the modeling instructions 228 to generate plane data for a representation of each plane to be rendered via the display with the three-dimensional representation of the joint. Each plane has a position and an orientation fixed relative to a bone of the joint. The plane moves with the bone movement. The orientation of the plane also changes as the bone reorients. The plane(s) may thus facilitate observation of the joint movement, which may be relatively small in scale. In this way, the depiction of the plane(s) allows the movement to be depicted in scale.” [0048], “The depiction of the planes may facilitate other aspects of the three-dimensional representation of the movement. For instance, the color (or other characteristic) of the plane(s) may be modified to indicate a certain circumstance or condition… Alternatively or additionally, the color or other characteristic of a plane may be modified to indicate that the position of the bone has exceeded a range, such as a normative range.” [0049])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Merette as outlined above with the GUI includes a three-dimensional element configured to represent the delta parameter information as taught by Branch, because it may improve the visualization, interpretation, and evaluation of the test data, as well as the evaluation of the joint [0019].
Regarding Claim 11, Lang discloses that the three-dimensional element comprises a plurality of sub-elements, each of the plurality of sub-elements corresponding to a first delta parameter value, a second delta parameter value, and a third delta parameter value (“the trapezoidal graphic 430C can include a joint gap indicator 432C, medial overlap indicator 439C and lateral overlap indicator 438C. The medial overlap indicator 439C provides a linear graphical display of the medial condyle overlap into the projected posterior femoral resection. In this example, the angle of the resection is not depicted, but rather a bar-graph type view of the overlaps of the condyles is shown instead. The lateral overlap indicator 438C depicts the lateral condyle overlap. The hashed portion of the medial overlap indicator 439C and lateral overlap indicator 438C illustrate the amount of laxity on each side of the joint illustrated in conjunction with the condyle overlap to assist in putting the laxity measurements into perspective in view of the planned resections.” [0067]).
Regarding Claim 12, Lang discloses that the first delta parameter value is based on a first difference between a first gap parameter value and a second gap parameter value; the second delta parameter value is based on a second difference between the first gap parameter value and a third gap parameter value; and the third delta parameter value is based on a third difference between the first gap parameter value and a fourth gap parameter value (“The operations performed by the computing device can include accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface, and outputting the graphical user interface to the display device. In this example, the surgical data can include soft tissue data indicative of at least, tension in soft tissues surrounding a surgical location. Calculating a medial total gap and a lateral total gap is based at least in part on the soft tissue data. The component set is recommended based at least in part on the medial total gap and lateral total gap. The graphical user interface includes an interactive trapezoidal graphic overlaid onto a graphical representation of a distal femur and a proximal tibia. The interactive trapezoidal graphic can include a graphical representation of the medial total gap, the lateral total gap, and at least a portion of the recommended component set.” [0075]).
Regarding Claim 13, Lang discloses that the first gap parameter value is a measure of a medial extension gap in a knee joint of a patient; the second gap parameter value is a measure of a lateral extension gap in the knee joint of the patient; the third gap parameter value is a measure of a medial flexion gap in the knee joint of the patient; and the fourth gap parameter value is a measure of a lateral flexion gap in the knee joint of the patient (“the soft-tissue section 425B includes trapezoidal graphic 430B, medial laxity indicator 434B, lateral laxity indicator 435B, medial gap data 436B, and lateral gap data 437B. In this example, the trapezoidal graphic 430B includes joint gap indicator 432B, balance angle indicator 4318 and resection angle indicator 433B as well as a textual display indicating the common gap distance across both medial and lateral side of the joint (19.0 mm in this example). The medial gap data 436 and lateral gap data 437B both include information such as Total Gap and Cut measurements. The medial laxity indicator 434B and the lateral laxity indicator 435B both include readouts indicating actual laxity measurement in addition to the Loose, Normal, or Tight indictors.” [0066]).
Regarding Claim 16, Merette discloses a computer-implemented method for generating and presenting a display of a visualization of joint parameters (“A system may include a display device and a computing device including a memory device with instructions. The instructions can cause the system to access surgical data, calculate medial and lateral gap data, calculate a recommended component set, and generate a graphical user interface.” [Abstract]), the method comprising:
extracting, by one or more processors, gap parameter information of a joint of a patient, the gap parameter information including at least a first gap measurement and a second gap measurement (“the technique 1200 can include operations such as accessing surgical data at 1202, calculating gaps at 1204, determining components at 1206, generating the GUI at 1208… The soft-tissue data can include actual measurements of tension in a medial and a lateral side of joint. The soft-tissue data can also (or alternatively) include gap distance measurements taken” [0070]),
calculating, based on the gap parameter information, delta parameter information, wherein the delta parameter information is calculated at least in part based on a difference between the first gap measurement and the second gap measurement (“FIG. 11E illustrates another example soft-tissue section including a variation on the trapezoidal graphic. In this example, trapezoidal graphic 430E can include balance angle indicator 431E, joint gap indicator 432E, resection angle indicator 433E, lateral overlap indicator 438E and medial overlap indicator 439E, The lateral overlap indicator 438E and the medial overlap indicator 439E in this example are angled to coincide with the resection angle indicator 433D and a graphical representation of the posterior portions of the medial and lateral condyles is also included in the distal femur graphic 426. Also in this example, the medial laxity indicator 434E and the lateral laxity indicator 435E include Loose/Neutral/Tight indicators as well as total laxity measurements and measures of tightness or looseness.” [0069];
generating, by the one or more processors, a graphical user interface (GUI) based on the delta parameter information (“the technique 1200 can include operations such as accessing surgical data at 1202, calculating gaps at 1204, determining components at 1206, generating the GUI at 1208” [0070]);
and displaying, by the one or more processors, the generated GUI on an electronic display (“the method can include operations such as accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface, and outputting the graphical user interface to the display device.“ [0086]).
Merette does not specifically teach that the GUI includes a three-dimensional element configured to represent the delta parameter information.
However, in a similar field of endeavor, Branch teaches A method of evaluating a joint includes generating visualization data for a three-dimensional representation of the joint to be rendered via a display [Abstract].
Branch also teaches that the GUI includes a three-dimensional element configured to represent the delta parameter information (“The modeling instructions 228 may also cause the processor 220 to incorporate one or more planes into the three-dimensional representations. In those cases, the processor 220 is further configured through the execution of the modeling instructions 228 to generate plane data for a representation of each plane to be rendered via the display with the three-dimensional representation of the joint. Each plane has a position and an orientation fixed relative to a bone of the joint. The plane moves with the bone movement. The orientation of the plane also changes as the bone reorients. The plane(s) may thus facilitate observation of the joint movement, which may be relatively small in scale. In this way, the depiction of the plane(s) allows the movement to be depicted in scale.” [0048], “The depiction of the planes may facilitate other aspects of the three-dimensional representation of the movement. For instance, the color (or other characteristic) of the plane(s) may be modified to indicate a certain circumstance or condition… Alternatively or additionally, the color or other characteristic of a plane may be modified to indicate that the position of the bone has exceeded a range, such as a normative range.” [0049])
It would have been obvious to an ordinary skilled person in the art before the effective filing
date of the claimed invention to modify the system of Merette as outlined above with the GUI includes a three-dimensional element configured to represent the delta parameter information as taught by Branch, because it may improve the visualization, interpretation, and evaluation of the test data, as well as the evaluation of the joint [0019].
Regarding Claim 17, Merette discloses that the gap parameter information includes a first gap parameter value, a second gap parameter value, a third gap parameter value, and a fourth gap parameter value (“The laxity scales will be different in flexion and extension. The laxity scales could be provided throughout all angles of flexion.” [0054], “In this example, the soft-tissue section 425B includes trapezoidal graphic 430B, medial laxity indicator 434B, lateral laxity indicator 435B, medial gap data 436B, and lateral gap data 437B. In this example, the trapezoidal graphic 430B includes joint gap indicator 432B, balance angle indicator 4318 and resection angle indicator 433B as well as a textual display indicating the common gap distance across both medial and lateral side of the joint (19.0 mm in this example). The medial gap data 436 and lateral gap data 437B both include information such as Total Gap and Cut measurements. The medial laxity indicator 434B and the lateral laxity indicator 435B both include readouts indicating actual laxity measurement in addition to the Loose, Normal, or Tight indictors,” [0066]).
Regarding Claim 18, Lang discloses that the first delta parameter value is based on a first difference between a first gap parameter value and a second gap parameter value; the second delta parameter value is based on a second difference between the first gap parameter value and a third gap parameter value; and the third delta parameter value is based on a third difference between the first gap parameter value and a fourth gap parameter value (“The operations performed by the computing device can include accessing surgical data, calculating a medial total gap and a lateral total gap, calculating a recommended component set, generating a trapezoidal graphic within a graphical user interface, and outputting the graphical user interface to the display device. In this example, the surgical data can include soft tissue data indicative of at least, tension in soft tissues surrounding a surgical location. Calculating a medial total gap and a lateral total gap is based at least in part on the soft tissue data. The component set is recommended based at least in part on the medial total gap and lateral total gap. The graphical user interface includes an interactive trapezoidal graphic overlaid onto a graphical representation of a distal femur and a proximal tibia. The interactive trapezoidal graphic can include a graphical representation of the medial total gap, the lateral total gap, and at least a portion of the recommended component set.” [0075]).
Regarding Claim 19, Lang discloses that the first gap parameter value is a measure of a medial extension gap in a knee joint of a patient; the second gap parameter value is a measure of a lateral extension gap in the knee joint of the patient; the third gap parameter value is a measure of a medial flexion gap in the knee joint of the patient; and the fourth gap parameter value is a measure of a lateral flexion gap in the knee joint of the patient (“the soft-tissue section 425B includes trapezoidal graphic 430B, medial laxity indicator 434B, lateral laxity indicator 435B, medial gap data 436B, and lateral gap data 437B. In this example, the trapezoidal graphic 430B includes joint gap indicator 432B, balance angle indicator 4318 and resection angle indicator 433B as well as a textual display indicating the common gap distance across both medial and lateral side of the joint (19.0 mm in this example). The medial gap data 436 and lateral gap data 437B both include information such as Total Gap and Cut measurements. The medial laxity indicator 434B and the lateral laxity indicator 435B both include readouts indicating actual laxity measurement in addition to the Loose, Normal, or Tight indictors.” [0066]).
Allowable Subject Matter
Claims 8-9, 14-15, & 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 03/13/2026 have been fully considered but they are not persuasive.
Regarding the U.S.C. 101 rejection of Claims 1-20 the applicant argues the following:
The steps recited in each independent claim, when viewed as a whole, do not recite mental processes. The claim recitation directed to extracting, by the one or more processors, gap parameter information of a joint of a patient, the gap parameter information including at least a first gap measurement and a second gap measurement is not directed to a mental process because the claimed activity cannot be performed in the human mind or with pen and paper. The Specification discloses that the gap parameter information is acquired from a medical imaging system that may be one of, for example, a “computed tomography (CT) scanner, a magnetic resonance imaging (MRI) machine, an x-ray machine, a radiography system, an ultrasound system,” etc. (Spec. at para. [0032]). These systems generate the recited gap parameter information by emitting signals or energy into the body, detecting responsive signals, and generating raw measurement data based on physical interactions with tissue. A human mind cannot generate such signals, detect sub-surface reflections or resonance responses, or transform those physical measurements into imaging data.
For at least these reasons, independent claims 1, 10, and 16 as amended herein do not recite methods of organizing human activity. Additionally, independent claims 1, 10, and 16 do not recite limitations that fall within the other two abstract idea groupings (e.g., certain methods of organizing human behavior or mathematical concepts).
Therefore, Applicant respectfully submits that claims 1-20 do not recite an abstract idea and therefore requests reconsideration and withdrawal of the rejection of claims 1-20 under 35 U.S.C. § 101.
The above-recited elements of independent claim 1 describe a method that optimizes processing of imaging data to generate a three-dimensional element configured to represent the delta parameter information. This provides a significant technical advantage over traditional approaches to providing bone laxity information to practitioners. For example, in conventional systems:
methods, and devices for processing patient image data and ligament laxity information are difficult to visualize in relation to a patient's joint, time consuming for a physician to understand, and difficult to effectively use in a procedure that includes joint balancing.
(Specification at [0003].) Furthermore, as emphasized in the August 2025 Memo, improvements to a technical field, even if data-driven, constitute practical application, and close cases should not be rejected unless ineligibility is “more likely than not.” See August 2025 Memo at p. 5. When the claim here is viewed as a whole, it clearly integrates any alleged abstract idea into a specific, practical medical solution. Accordingly, Applicant respectfully submits that claims 1-20 are not directed to an abstract idea and therefore requests reconsideration and withdrawal of the rejection of claims 1-20 under 35 U.S.C. § 101.
However, it is noted that following the amendments to independent claims 1,10 & 16; the claims still fail at overcoming a U.S.C. 101 rejection.
In Step 2A Prong One (Judicial Exception), it is noted that the current amended claims continue to recite a mathematical concept of calculating “delta parameter information” which is a mere difference computation. These calculations are still viewed as being a mental process that can be conducted by a user who conducts a generic data gathering step of acquiring “gap parameter information of the joint” and uses pen and paper to conduct the basic delta parameter calculations.
As for the Step 2A Prong Two (integration into a practical application), it is still noted that the current amended claims continue to not materially integrate the mental process into a practical application. Under the amended claims the delta parameter information is displayed by using generic displays and a generic “three dimensional element”. As seen in MPEP 2106.04(d) Examples of 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 v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016).
In Step 2B (inventive concept) it is noted, that the idea of acquiring measurements, conducting basic calculations, and displaying the calculations using generic display elements and a generic display does not sufficiently cover an inventive concept.
Applicant’s arguments with respect to the U.S.C. 103 rejection of claim(s) 1-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure (US 20240008925 A1, US 20220183767 A1, US 20230181326 A1, US 20230149090 A1, US 20220031473 A1).
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 STEVEN MALDONADO whose telephone number is 703-756-1421. The examiner can normally be reached 8:00 am-4:00 pm PST M-Th Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
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/Steven Maldonado/
Patent Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/Supervisory Patent Examiner, Art Unit 3797
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