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 .
Response to Amendment
In the amendment filed on March 3, 2026, the following has occurred: claim(s) 16, 22 have been amended. Now, claim(s) 1-22 are pending.
Notice to Applicant
The Examiner has withdrawn the 35 U.S.C. 101 rejection(s) for the current claims 1-22 because of the claimed portions of “robotically assisting a surgical tool to cut a bone of the joint according to the updated surgical plan, wherein robotically assisting a surgical tool comprises at least one of automatically navigating a guide associated with the surgical tool, providing tactile feedback to the surgical tool, automatically controlling a motor associated with the surgical tool, and actuating a robotic arm affixed to the surgical tool” in independent claim 1, “robotically assist a surgical tool to cut a bone of the joint according to the updated surgical plan by at least one of: automatically navigating a guide associated with the surgical tool, providing tactile feedback to the surgical tool, automatically controlling a motor associated with the surgical tool, and actuating a robotic arm affixed to the surgical tool” in independent claim 16, and “robotically assist a surgical tool to cut a bone of the joint according to the updated surgical plan by at least one of: automatically navigating a guide associated with the surgical tool, providing tactile feedback to the surgical tool, automatically controlling a motor associated with the surgical tool, and actuating a robotic arm affixed to the surgical tool” in independent claim 22. The newly amended claims overcome the 35 U.S.C. 101 rejection(s) as the surgical tool is required to carry out the physical tasks that are based on an updated surgical plan. These functions could not be reasonably viewed as generally linking the abstract idea to a particular technological environment, and the additional elements amount to significantly more, and integrate the abstract idea into a practical application.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-22 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5-7, 9, 15 of U.S. Patent No. 12,127,791 in view of Otto et al. (U.S. Patent Pre-Grant Publication No. 2010/0076563). The subject matter of each limitation of the present application is present in the ‘791 application with the exception of claims 2-8, 11, 14, 17-20. The cited prior art of record teaches the missing features of the ‘466 application as described below in the basis of rejection. A person having skill in the art would have been motivated to combine the ‘466 application with the cited prior art in order to provide alternative preoperative and intra-operative “templating” method steps (See Background of the Invention of Otto in Paragraph [0008]).
Claim Rejections - 35 USC § 103
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 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 1-22 are rejected under 35 U.S.C. 103 as being unpatentable over Otto et al. (U.S. Patent Pre-Grant Publication No. 2010/0076563) in view of McKinnon et al. (U.S. Patent Pre-Grant Publication No. 2013/0203031) in further view of Saget et al. (U.S. Patent Pre-Grant Publication No. 2019/0122330).
As per independent claim 1, Otto discloses a computer-implemented method of performing a surgical plan on a joint of a patient, the computer-implemented method comprising:
obtaining the surgical plan comprising an implant model, an implant size, and an initial value for each of a plurality of placement parameters, wherein each placement parameter relates to one of a position and an orientation for one of a pair of implant components (See Paragraph [0088]: A preoperative planning tools for determining optimal alignment and positioning of all types of prosthetic components, running a body simulation of a patient's knee (or other joint) with slightly different sizes and/or spatial orientations of a particular orthopedic implant during each iteration and after determining which spatial orientation(s) and/or sizes of said orthopedic implant provides the best overall prosthesis performance value, which the Examiner is interpreting the preoperative planning tools to encompass obtaining the surgical plan comprising an implant model, an implant size, and an initial value for each of a plurality of placement parameters, wherein each placement parameter relates to one of a position and an orientation for one of a pair of implant components);
selecting a single target condition for the joint from the group consisting of joint stability, joint pain, implant longevity, and joint balance (See [0072], [0111]: The user-defined thresholds may include minimum acceptable requirements for at least one performance characteristic, which the Examiner is interpreting the user-defined thresholds to encompass a single target condition for the joint, interpreting joint laxity to encompass joint stability, interpreting fatigue life to encompass joint pain, interpreting implant longevity to encompass implant longevity, and interpreting biomechanics to encompass joint balance);
selecting one or more joint performance equations from a library stored on a computer-readable memory, wherein the selecting is based on one or more of the implant model, the implant size, and patient demographic information, wherein each joint performance equation defines an output response that is dependent on the plurality of placement parameters and relates to the single target condition (See [0063]-[0064]: Each database may include any one or more of an image dataset, an imageless, dataset, an equation, a tolerance, a geometric model, patient anatomical data, or a parameter relative to the anatomy, and the computer modeling software may reference the characterization charts, lookup tables, or databases in order to quickly determine which implant configurations to start with for a particular patient, which the Examiner is interpreting the database may include any one or more of an image dataset, an imageless, dataset, an equation, a tolerance, a geometric model, patient anatomical data, or a parameter relative to the anatomy to encompass selecting one or more joint performance equation from a library of joint performance equations based on one or more of the implant model, the implant size, and patient demographic information and the computer modeling software may reference the characterization charts, lookup tables, or databases in order quickly determine which implant configurations to start with for a particular patient to encompass wherein each of the one or more joint performance equation defines an output response that is dependent on the plurality of placement parameters and relates to the single target condition);
receiving a selected value from the range of values for each placement parameter of the subset (See [0082]: The surgeon may define one or more ranges, thresholds, variables, limits, or parameters to set a size and spatial orientation envelope for the one or more virtual implants which represent the one or more implants to be implanted into the patient, and prompts can include maximum or minimum limits for implant size, changes in position, and changes in angular position, which the Examiner is interpreting the ranges and prompts to encompass a selected value from the range of values for each placement parameter of the subset);
updating the surgical plan based on the selected value for each placement parameter of the subset (See [0088]: The preoperative planning tools is able to iteratively run a body simulation of a patient's knee with slightly different parameters, which the Examiner is interpreting iteratively run a body simulation of a patient's knee with slightly different parameters to encompass updating the surgical plan based on the selected value.)
While Otto discloses the method of selecting one or more joint performance equations from a library stored on a computer-readable memory, wherein the selecting is based on one or more of the implant model, the implant size, and patient demographic information, wherein each joint performance equation defines an output response that is dependent on the plurality of placement parameters and relates to the single target condition, Otto may not explicitly teach identifying a subset of placement parameters from among the plurality of placement parameters and locking a value of each remaining placement parameter at the corresponding initial value, wherein the subset comprises at least one and no more than three placement parameters to which the output responses of the one or more joint performance equations are most sensitive; and
calculating, for each of the one or more joint performance equations, the output response across a range of values for each placement parameter of the subset based on the locked value of each remaining placement parameter.
McKinnon teaches a computer-implemented method of performing a surgical plan on a joint of a patient, the computer-implemented method comprising:
identifying a subset of placement parameters from among the plurality of placement parameters and locking a value of each remaining placement parameter at the corresponding initial value, wherein the subset comprises at least one and no more than three placement parameters to which the output responses of the one or more joint performance equations are most sensitive (See [0104]-[0105], [0137]: The biomechanic and anatomic fit optimization steps may result in a different general size group option for the orthopedic implant being specified than what was originally determined in the initial general size group optimization steps, the biomechanic fit optimization steps may identify an optimal biomechanic size option for the particular patient that does not correspond to the general size group option originally identified, which the Examiner is interpreting identify an optimal biomechanic size option for the particular patient to encompass the claimed portion when combined with Otto as Otto discloses in Paragraph [0111] that identifies a performance characteristic that can be a natural postoperative feeling (no pain and good proprioception); and
calculating, for each of the one or more joint performance equations, the output response across a range of values for each placement parameter of the subset based on the locked value of each remaining placement parameter (See [0131]-[0132]: Some orthopedic factors may impact the various orthopedic responses in different ways and the orthopedic responses may be associated with weighted values such that the optimization process accords greater weight to certain responses than others, which the Examiner is interpreting to encompass the claimed portion as the Examiner is interpreting known values to encompass the locked value of each remaining placement parameter.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Otto to include identifying a subset of placement parameters from among the plurality of placement parameters and locking a value of each remaining placement parameter at the corresponding initial value, wherein the subset comprises at least one and no more than three placement parameters to which the output responses of the one or more joint performance equations are most sensitive; and calculating, for each of the one or more joint performance equations, the output response across a range of values for each placement parameter of the subset based on the locked value of each remaining placement parameter as taught by McKinnon. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Otto with McKinnon with the motivation of optimizing an orthopedic procedure for a particular patient (See Background of McKinnon in Paragraph [0003]).
While Otto/McKinnon discloses the method as described above, Otto/McKinnon may not explicitly teach robotically assisting a surgical tool to cut a bone of the joint according to the updated surgical plan, wherein robotically assisting a surgical tool comprises at least one of automatically navigating a guide associated with the surgical tool, providing tactile.
Saget teaches a method for robotically assisting a surgical tool to cut a bone of the joint according to the updated surgical plan (See [0083], [0131]-[0132]: The computing platform is configured to synchronize with surgical facilitator such as a robot or a haptic feedback device to provide the same predictive guidance as described throughout as an enabler for robotic surgery, and the data layer is made of a collection of data from various networks, the data layer includes information on bone cut guidance), wherein robotically assisting a surgical tool comprises at least one of automatically navigating a guide associated with the surgical tool (See [0153]: The use of multivariate relationship datasets and outcomes prediction modules can provide the user with impaired healing predictions such as in the case of which implant to use, and provide guidance for a robot or a predictive output of an optimal implant position or normal healing/abnormal healing expectation and probability of success, which the Examiner is interpreting guidance for a robot to encompass automatically navigating a guide associated with the surgical tool), providing tactile feedback to the surgical tool, automatically controlling a motor associated with the surgical tool, and actuating a robotic arm affixed to the surgical tool.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the method of Otto/McKinnon to include robotically assisting a surgical tool to cut a bone of the joint according to the updated surgical plan, wherein robotically assisting a surgical tool comprises at least one of automatically navigating a guide associated with the surgical tool, providing tactile as taught by Saget. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Otto/McKinnon with Saget with the motivation of provide intraoperative automated intelligence guided surgical and medical situational awareness support and guidance (See Background of the Invention of Saget in Paragraph [0008]).
Claims 16 and 22 mirror claim 1 only within different statutory categories, and are rejected for the same reason as claim 1.
The additions of “a processor in operable communication with the surgical tool;”, “a non-transitory processor-readable storage medium comprising one or more instructions that, when executed, cause the processor to:…” in independent claim 16 are encompassed by Otto in Paragraph [0052]: "For instance, a patient may be measured and digitized utilizing any one or more of gait lab equipment, fluoroscopy equipment, cameras, position markers, lower extremity motion capture, anthropometrics, radiological scans (e.g., CT, MRI), accelerometers, strain gauges, electromyography (EMG), piezoelectric devices, transducers, force sensors, position sensors, infrared, magnetic fields, signal triangulation, RFID, biodex balance characterization, radio waves, computer-assisted-Surgery (CAS) devices, 3D imaging systems, radiostereometric analysis (RSA) devices, and force plates, in order to characterize the biomechanics within a patient's knee during said activities" and Otto in Paragraph [0100]: "The computing device generally converts small electric voltage potential changes caused by deflections in said transducers, strain gauges, and accelerometers to quantifiable stresses, loads, or accelerations that can be displayed to a surgeon during trial reduction."
The additions of “a display device;”, “a processor in operable communication with the surgical tool and the display device, wherein the processor is configured to:” in independent claim 22 are encompassed in Otto in Paragraph [0052]: "For instance, a patient may be measured and digitized utilizing any one or more of gait lab equipment, fluoroscopy equipment, cameras, position markers, lower extremity motion capture, anthropometrics, radiological scans (e.g., CT, MRI), accelerometers, strain gauges, electromyography (EMG), piezoelectric devices, transducers, force sensors, position sensors, infrared, magnetic fields, signal triangulation, RFID, biodex balance characterization, radio waves, computer-assisted-Surgery (CAS) devices, 3D imaging systems, radiostereometric analysis (RSA) devices, and force plates, in order to characterize the biomechanics within a patient's knee during said activities" and Otto in Paragraph [0094]: “After simulations are run, results including one or more performance characteristics are outputted, and recommendations are made based on the performance analysis.”
As per claim 2, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein each placement parameter is selected from the group consisting of: medial-lateral position of one of the pair of implant components, anterior-posterior position of one of the pair of implant components, superior-inferior position of one of the pair of implant components, rotation of one of the pair of implant components, slope of one of the pair of implant components, offset of one of the pair of implant components, and orientation of one of the pair of implant components (See [0057]-[0058]: Input variables that are changed or added within the computer simulation models during each modeling iteration may include, for instance, the size of each component of the desired implant, the anterior-posterior positioning of each component of the desired implant (Examiner is interpreting to encompass anterior-posterior position of one of the pair of implant components), the medial-lateral positioning of each component of the desired implant (Examiner is interpreting to encompass medial-lateral position of one of the pair of implant components), the superior-inferior positioning of each component of the desired implant (Examiner is interpreting to encompass superior-inferior position of one of the pair of implant components), the internal-external rotation positioning of each component of the desired implant (Examiner is interpreting to encompass rotation of one of the pair of implant components), and the computer simulation software may indicate the best A-P slope angles, and the best M-L orientations, which the Examiner is interpreting to encompass slope of one of the pair of implant components, offset of one of the pair of implant components, and orientation of one of the pair of implant components.)
Claim 17 mirrors claim 2 only within a different statutory category, and is rejected for the same reason as claim 2.
As per claim 3, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a knee joint (See [0055]: The prosthesis product can be a knee prosthesis product) and each placement parameter is selected from the group consisting of: femoral component medial-lateral position, femoral component anterior-posterior position, femoral component superior-inferior position, femoral component varus/valgus rotation, femoral component internal/external rotation, tibial component medial-lateral position, tibial component anterior-posterior position, tibial component superior inferior position, tibial component varus/valgus rotation, tibial component internal/external rotation, and tibial component slope (See [0111]: The user-defined thresholds may include minimum acceptable requirements for at least one performance characteristics, which the Examiner is interpreting the performance characteristics to encompass placement parameter as the performance characteristics include kinematics (tibiofemoral and patellofemoral interactions, anterior-posterior translation, flexion, internal/external tibial or femoral rotation, patella flexion, patella tilt, patella spin, femoral rollback).)
Claim 18 mirrors claim 3 only within a different statutory category, and is rejected for the same reason as claim 3.
As per claim 4, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a hip joint (See [0090]-[0091]: Similar models may be created for a hip) and each placement parameter is selected from the group consisting of: medial-lateral position of one of the pair of implant components, anterior-posterior position of one of the pair of implant components, superior-inferior position of one of the pair of implant components, rotation of one of the pair of implant components, slope of one of the pair of implant components, cup inclination angle, cup anteversion angle, cup depth, femoral offset, leg length, and femoral version (See [0111]: The user-defined thresholds may include minimum acceptable requirements for at least one performance characteristics, which the Examiner is interpreting the performance characteristics to encompass placement parameter as the performance characteristics include kinematics (tibiofemoral and patellofemoral interactions, anterior-posterior translation, flexion, internal/external tibial or femoral rotation, patella flexion, patella tilt, patella spin, femoral rollback), biomechanics, kinetics, anatomic bone fit.)
Claim 19 mirrors claim 4 only within a different statutory category, and is rejected for the same reason as claim 4.
As per claim 5, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a shoulder joint (See [0090]: Similar models may be similarly created for a shoulder) and each placement parameter is selected from the group consisting of: medial-lateral position of one of the pair of implant components, anterior-posterior position of one of the pair of implant components, superior-inferior position of one of the pair of implant components, rotation of one of the pair of implant components, slope of one of the pair of implant components, humeral stem version, humeral offset, glenoid version, glenoid inclination, glenoid tilt, glenosphere orientation, glenosphere offset, and offset direction (See [0111]: The user-defined thresholds may include minimum acceptable requirements for at least one performance characteristics, which the Examiner is interpreting the performance characteristics to encompass placement parameter as the performance characteristics include kinematics (tibiofemoral and patellofemoral interactions, anterior-posterior translation, flexion, internal/external tibial or femoral rotation, patella flexion, patella tilt, patella spin, femoral rollback), biomechanics, kinetics, anatomic bone fit.)
Claim 20 mirrors claim 5 only within a different statutory category, and is rejected for the same reason as claim 5.
As per claim 6, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint stability comprises mid-flexion stability (See [0111]: Performance characteristics can include stability and kinetics (e.g., flexion moments)); or
the joint pain comprises anterior knee pain (See [0111]: Performance characteristics can include anterior-posterior forces, and natural postoperative feeling ([0113]: Reduce post-operative anterior knee pain).)
As per claim 7, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein each range of values includes the corresponding initial value for the placement parameter (See [0082]: The surgeon may define one or more ranges, thresholds, variables, limits, or parameters to set a size and spatial orientation envelope for the one or more virtual implants which represent the one or more implants to be implanted into the patient, and prompts can include maximum or minimum limits for implant size, changes in position, and changes in angular position, which the Examiner is interpreting a size and spatial orientation envelope to encompass each range of values includes the corresponding initial value for the placement parameter.)
As per claim 8, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein each output response is selected from the group consisting of: a joint rotation response, joint rollback response, a soft tissue strain response, a soft tissue force response, a soft tissue angle response, and a contact force response (See [0051]-[0053]: Best possible performance characteristics can include range of motion, kinematics, soft-tissue impingent, and anatomic fit, which the Examiner is interpreting the performance characteristics to encompass the claimed portion.)
As per claim 9, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a knee joint (See [0055]: The prosthesis product can be a knee prosthesis product) and each output response is selected from the group consisting of: internal-external rotation, medial rollback, lateral rollback, anterior MCL strain, posterior MCL strain, anterior LCL strain, posterior LCL strain, q-angle, quadriceps force, patellofemoral contact force, tibial implant force, and tibiofemoral joint contact force (See [0053]: The performance characteristics can include range of motion, kinematics, kinetics, Q-angle, which the Examiner is interpreting the performance characteristics to encompass the claimed portion.)
As per claim 10, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a knee joint (See [0055]: The prosthesis product can be a knee prosthesis product), the single target condition is mid-flexion stability (See [0111]: Performance characteristics can include stability and kinetics (e.g., flexion moments)), and the one or more joint performance equations consist of:
a first joint performance equation having a first output response comprising anterior MCL strain (See [0059]: The computer simulation models may take into consideration stresses in the medical and lateral collateral ligaments (MCL, PCL), anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), quadriceps muscle, patellar tendon, medical and lateral retinaculae, and other soft tissues during iterative simulation, and the most stability and lowest forces at the implant-bone interfaces determined, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in [0126]);
a second joint performance equation having a second output response comprising posterior MCL strain (See [0059]: The computer simulation models may take into consideration stresses in the medical and lateral collateral ligaments (MCL, PCL), anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), quadriceps muscle, patellar tendon, medical and lateral retinaculae, and other soft tissues during iterative simulation, and the most stability and lowest forces at the implant-bone interfaces determined, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in [0126]);
a third joint performance equation having a third output response comprising anterior LCL strain ([0059]: The computer simulation models may take into consideration stresses in the medical and lateral collateral ligaments (MCL, PCL), anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), quadriceps muscle, patellar tendon, medical and lateral retinaculae, and other soft tissues during iterative simulation, and the most stability and lowest forces at the implant-bone interfaces determined, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in [0126]); and
a fourth joint performance equation having a fourth output response comprising posterior LCL strain (See [0059]: The computer simulation models may take into consideration stresses in the medical and lateral collateral ligaments (MCL, PCL), anterior cruciate ligament (ACL), posterior cruciate ligament (PCL), quadriceps muscle, patellar tendon, medical and lateral retinaculae, and other soft tissues during iterative simulation, and the most stability and lowest forces at the implant-bone interfaces determined, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in [0126].)
As per claim 11, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a knee joint (See [0055]: The prosthesis product can be a knee prosthesis product), the single target condition is anterior knee pain (See [0111]: Performance characteristics can include anterior-posterior forces, and natural postoperative feeling ([0113]: Reduce post-operative anterior knee pain)), and the one or more joint performance equations consist of:
a first joint performance equation having a first output response comprising q-angle (See [0105]: Expected quadriceps force or Q-angle can be determined, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in [0126]);
a second joint performance equation having a second output response comprising quadriceps force (See [0105]: Expected quadriceps force or Q-angle can be determined, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in [0126]); and
a third joint performance equation having a third output response comprising patellofemoral contact force (See [0111]: The performance characteristics can include patellofemoral interactions, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in [0126].)
As per claim 12, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a knee joint (See [0055]: The prosthesis product can be a knee prosthesis product), the single target condition is implant longevity (See [0111]: Performance characteristics can include implant longevity), and the one or more joint performance equations consist of a joint performance equation wherein the output response comprises tibial implant force (See Paragraph [0104]: The transducers, strain gauges, accelerometers and/or position markers may be located in various areas of the femoral component trial including anterior or posterior cams to measure tibial post impact forces, which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in Paragraph [0126].)
As per claim 13, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches wherein the joint is a knee joint (See [0055]: The prosthesis product can be a knee prosthesis product), the single target condition is joint balance (See [0080]: Optimizing biomechanic performance is one of the functions of the patient computer models, which the Examiner is interpreting biomechanic performance to encompass joint balance), and the one or more joint performance equations consist of a joint performance equation wherein the output response comprises tibiofemoral contact force (See Paragraph [0111]: A computer simulation model can utilize performance characteristics may relate to kinematics (e.g., tibiofemoral and patellofemoral interactions), which the Examiner is interpreting to encompass the claimed portion when combined with McKinnon's teachings of equations and orthopedic responses in Paragraph [0126].)
As per claim 14, Otto/McKinnon/Saget discloses the method of claim 1 as described above. Otto further teaches further comprising displaying, on a display, a graphical representation of the output response for the single target condition across the range of values (See [0107]: The model is run for 1-N simulation iterations, during which time, the relative sizes, geometric relationships, and relative spatial orientations of each implant component are changed within a predefined parameter range, which the Examiner is interpreting the model to encompass displaying, on a display, a graphical representation of the output response as the surgeon can interact with the model.)
Claim 21 mirrors claim 14 only within a different statutory category, and is rejected for the same reason as claim 14.
As per claim 15, Otto/McKinnon/Saget discloses the method of claims 1 and 14 as described above. Otto further teaches wherein the subset consists of three placement parameters and wherein the graphical representation comprises a surface response map of each output response as a function of the three placement parameters (See [0088]: The B-spline 3D surface portion or the at least three strategically positioned contact points spatially orient the block in all six degrees of freedom relative to the patient's bony anatomy in such a way that the bony resections facilitated by said patient-specific cutting guide devices will effectively position one or more implants in the same optimal spatial orientation (relative to said patient's bony anatomy) suggested by the modeling software, which the Examiner is interpreting the B-spline 3D surface portion to encompass a surface response map of each output response as a function of the three placement parameters.)
Response to Arguments
In the Remarks filed on March 3, 2026, the Applicant argues that the newly amended and/or added claims overcome the Claim Objection(s), Double Patenting rejection(s), and 35 U.S.C. 103 rejection(s). The Examiner acknowledges that the newly added and/or amended claims overcome the Claim Objection(s). However, the Examiner does not acknowledge that the newly added and/or amended claims overcome the Double Patenting rejection(s) and 35 U.S.C. 103 rejection(s).
The Applicant argues that:
(1) claims 1-22 stand rejected on the grounds of non-statutory double patenting as being unpatentable over claims 1-3, 5-7, 9 and 15 of U.S. Patent No. 12,127,791 in view of U.S. Publication No. 2010/0076563 (hereinafter "Otto"). Applicant respectfully declines to address the current rejection at this time because there are other pending rejections that may impact claim scopes, and will address the current rejection when the application is in condition of allowance;
(2) claims 1-22 stand rejected under 35 U.S.C. § 103 as being unpatentable over Otto in view of U.S. Publication No. 2013/0203031 (hereinafter "McKinnon") and further in view of U.S. Publication No. 2019/0122330 (hereinafter "Saget"). Whether taken alone or in combination, the cited references do not show or render obvious "selecting a single target condition for the joint from the group consisting of joint stability, joint pain, implant longevity, and joint balance," as recited in independent claims 1, 16, and 22. The Office Action alleges that Otto teaches the "selecting a single target condition" limitation, relying on paragraphs [0072] and [0111] of Otto. See Office Action, pg. 8. Specifically, the Office Action interprets "user-defined thresholds" that "may include minimum acceptable requirements for at least one performance characteristic" as encompassing a single target condition for the joint. See Office Action, pg. 8. Applicant respectfully disagrees. Otto discloses that "[t]he user-defined thresholds may include minimum acceptable requirements for at least one performance characteristic." See Otto, para. [0111]. However, the Office has not shown that this disclosure amounts to selecting a single target condition toward which the optimization is directed. Rather, Otto's user-defined thresholds appear to serve as filters to exclude simulation results that do not meet minimum requirements across various performance characteristics. The optimization itself continues to address multiple performance objectives simultaneously. This is fundamentally different from the subject matter at issue, which requires selecting a single target condition such that the joint performance equations relate to that single selected condition. Indeed, Otto expressly describes its optimization approach as multi-objective. Otto states: "[i]t is therefore a goal of the present invention to help a surgeon determine how to implant one or more prosthetic components of a prosthesis in order to get the best overall anatomic fit (802), intra-operative ligament balance (804), and postoperative biomechanic performance (806) simultaneously (emphasis added)." See Otto, para. [0024]. Thus, Otto's methodology appears to be directed to optimizing multiple performance characteristics at the same time-not selecting a single target condition from among them. The Office has not explained how the ability to set minimum thresholds changes the fundamental multi-objective nature of Otto's optimization approach. It should also be noted that setting a threshold is not the same as selecting a target. A threshold establishes a minimum acceptable value that results must satisfy; it does not direct the optimization toward achieving a particular goal. In contrast, Applicant's independent claims require that a single target condition be selected and that the joint performance equations relate to that single target condition-meaning the optimization is focused on that selected condition rather than on multiple objectives simultaneously. The Office has not pointed to any disclosure in Otto suggesting that a user can select a single target condition and have the system optimized specifically for that condition (e.g., disregarding or deprioritizing other performance characteristics). As best understood, Otto's system optimizes for the best overall anatomic fit, ligament balance, and biomechanic performance together;
(3) the Office Action maps Otto's performance characteristics to the claimed target conditions as follows: "joint laxity" [Wingdings font/0xE0] joint stability, "fatigue life" [Wingdings font/0xE0] joint pain, "implant longevity" [Wingdings font/0xE0] implant longevity, "biomechanics" [Wingdings font/0xE0] joint balance. See Office Action, pg. 8. Even assuming arguendo that some of these mappings are reasonable, the mapping of "fatigue life" to "joint pain" does not appear to be supported. In Otto, "fatigue life" refers to the durability of the implant-i.e., how long the implant will last before failing due to mechanical fatigue. See Otto, para. [0111]. This appears to be a measure of implant longevity, not joint pain. Accordingly, the Office has not shown that the group of listed characteristics in Otto corresponds to the claimed group of target conditions. For at least these reasons, the Office has not demonstrated that Otto teaches or suggests the subject matter at issue. Nor has the Office shown that McKinnon or Saget supplies the missing limitation. McKinnon teaches using weighted values so that optimization accords greater weight to certain orthopedic responses than others. See McKinnon, para. [0056]. However, the Office has not shown that weighting constitutes selecting a single target condition. McKinnon's approach appears to remain multi-objective; it allows some objectives to be prioritized over others through weighting, but this is different from selecting a single target condition as claimed. Saget teaches AI-based outcome prediction for surgical guidance but does not address selecting a single target condition from among joint stability, joint pain, implant longevity, and joint balance. Accordingly, the Office has not demonstrated that the combination of Otto, McKinnon, and Saget teaches or suggests every element of Applicant's independent claims. Applicant respectfully requests withdrawal of this rejection.
In response to argument (1), the Applicant has not addressed the Double Patenting Rejection(s), and so the Double Patenting rejection(s) stand.
In response to argument (2), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains that the combination of Otto/McKinnon/Saget teaches the claims 1-22 as described above in the 35 U.S.C. 103 rejection(s). Otto teaches “selecting a single target condition for the joint from the group consisting of joint stability, joint pain, implant longevity, and joint balance” as Otto describes in Paragraph [0111]: “FIG. 16 illustrates a computer simulation model (1000) according to some embodiments. The model (1000) may be, for instance, part of a submodel (920). During each iteration, the model (1000) records magnitudes and directions of forces (1002, 1004, 1006) in order to characterize an iteration force environment. Iteration force environments can be uploaded to a database that applies user-defined thresholds set by a surgeon or engineer. The user-defined thresholds may include minimum acceptable requirements for at least one performance characteristic. Performance characteristics may relate to, without limitation, wear (mm.sup.3 per million cycles), stress, range of motion (ROM), kinematics (e.g., tibiofemoral and patellofemoral interactions, anterior-posterior translation, flexion, internal/external tibial or femoral rotation, patella flexion, patella tilt, patella spin, femoral rollback), kinetics (e.g., compressive forces, forces contributing to shear, torque, anterior-posterior forces, medial-lateral forces, and flexion moments acting on implant components), biomechanics, implant robustness, fatigue life, fixation strength, shear loading at cement or ingrowth interface, bony impingement, soft-tissue impingement, joint laxity, subluxation, subsidence, ligament balancing, ligament force, quadriceps force, knee efficiency, patellar femoral impingement, Q-angle, stability, anatomic bone fit, implant longevity, and natural postoperative feeling (no pain and good proprioception).” The surgeon’s ability to set user-defined thresholds may include minimum acceptable requirements for at least one performance characteristic teaches “selecting a single target condition” as the “performance characteristics” encompass “target condition”. The Applicant’s Specification does not explicitly describe the “target condition”, the Specification describes “In some embodiments, the surgeon may provide input related to a target influence. For example, the surgeon may identify a post-operative condition of concern (e.g., any of the target influences described in Table 2). In some embodiments, the surgeon provides input to the computing device to indicate the selected target influence. Accordingly, the computing device may select a subset of the KPEs having output responses pertinent to the selected target influence. For example, where mid-flexion stability is a concern, KPEs related to anterior MCL strain, posterior MCL strain, anterior LCL strain, and posterior LCL strain may be pertinent (as described in Table 2) while additional KPEs may be less relevant. Accordingly, the system may provide visual informatics displays as described herein specifically with respect to the pertinent output responses.” in Paragraph [0212] the “target influence” are described in Table 1 of the Applicant’s Specification. The Examiner maintains that Otto’s description of “the surgeon may define one or more ranges, thresholds, variables, limits, or parameters to set a size and spatial orientation envelope for the one or more virtual implants which represent the one or more implants to be implanted into the patient” (Paragraph [0082]) teaches the ability to select a single target condition, and “Optimization parameters may include, but are not limited to: minimizing bone-implant interface stresses, reducing stress-shielding and/or implant subsidence, minimizing quadriceps and hamstring co-contraction, minimizing quadriceps forces required for various activities, achieving a natural screw-home position as shown in FIG. 2a, reducing stress on posterior knee tissues, reducing shear loads and stresses on the patella-bone interface, matching EMG patterns of individuals with normal joint function and normal biomechanic function, achieving normal kinematics, and achieving proper ligament tension and constraint for one or more of the ACL, PCL, MCL, and LCL.” (Paragraph [0086]) teaches the “optimization”. Otto describes a possibility for multiple performance characteristics to be selected, however Otto states “minimum acceptable requirements for at least one performance characteristic” which the Examiner is interpreting under broadest reasonable interpretation to encompass minimum acceptable requirements for one performance characteristic. Further, Otto describes in Paragraph [0086]: “The benefit of the present invention is that a surgeon can perform hundreds of virtual surgeries by means of iterative analysis, in order to determine the optimal size, optimal placement, optimal spatial orientation, optimal alignment, and/or the best performance compromise between anatomic fit (802) and biomechanic function (806), all while taking into consideration intra-operative soft tissue constraints such as ligament balance (804).” This disclosure of Otto does not require all of “optimal size, optimal placement, optimal spatial orientation, optimal alignment, and/or the best performance compromise between anatomic fit (802) and biomechanic function (806)” to be taken into account, there is a possibility to only allow one to be taken into account. The 35 U.S.C. 103 rejection(s) stand.
In response to argument (3), the Examiner does not find the Applicant’s argument(s) persuasive. The Examiner maintains the mapping of “joint laxity” (joint looseness) to “joint stability” as a loose joint would not be stable. The Examiner maintains the mapping of “fatigue life” to “joint pain” as the fatigue of the joint/implant over time can cause pain, further Paragraph [0052] describes inquiring a patient for pain levels. The Examiner maintains the mapping of “implant longevity” to “implant longevity”. The Examiner maintains the mapping of “biomechanics” to “joint balance” as biomechanics encompasses “joint balance” as biomechanics is related to the analyzing how forces affect motion, stability, and performance in humans. The Examiner maintains that the combination of Otto/McKinnon/Saget teaches the claims 1-22 as described above. The 35 U.S.C. 103 rejection(s) stand.
Conclusion
THIS ACTION IS MADE FINAL. 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 Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683
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