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 .
Status of Claims
Claims 10-17 are pending in this application. Claims 1-9 are cancelled, Claim 17 is newly added, and Claims 10-17 have been examined on the merits.
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 10-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 10 recites determine patella information based on the tracking information, and generate a patella model configured as a virtual representation of the patella. The limitation of determine patella information based on the tracking information, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind i.e., visually observing information regarding the patella. Further, (although it is not required) if these processes are performed by an “inherent” processor, these claimed steps could easily be performed by a generic computer component as the claimed limitations do not require any specialized processor. Similarly, to generate a patella model configured as a virtual representation of the patella, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind i.e., using the mind or pen and paper to create a model image of the patella upon viewing the image. Further, limitations to “receive tracking information”, is considered an extra solution activity recited at a high level of generality with no specific machine or device disclosed that is not generic or known to perform the limitations solution activity recited at a high level of generality with no specific machine or device disclosed that is not generic or known to perform the limitations. If a Claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only
recites one additional element — using one or more generic processors for execution. The processors are recited at a high-level of generality (i.e., at least one computing device, a display device, processing circuitry, a memory) such that it amounts no more than mere instructions to apply the exception using processors. Accordingly, this additional element does 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 processors to perform the identifying and determining steps amounts to no more than mere instructions to apply the exception using generic processors. Mere instructions to apply an exception using generic processors cannot provide an inventive concept. The claim is not patent eligible.
The dependent claims 11-16 are also directed to an abstract idea as the depending claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The elements in those claims 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. Therefore, the depending claims, are, also not patent eligible.
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.
Claims 10, 15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Amanatullah ‘729 (US20200383729A1) in view of Amanatullah ‘398 (US20200405398A1).
Regarding Claim 10,
Amanatullah ‘729 teaches a computer-assisted surgical system, comprising: at least one computing device, comprising: a display device (corresponding disclosure in at least [0075], where there is a display device “such as in the form of surgical options presented on a standalone display (e.g., a monitor)”);
processing circuitry; and a memory coupled to the processing circuitry, the memory comprising instructions that, when executed by the processing circuitry (corresponding disclosure in at least [0096], where there is a memory for executing instructions “the computer-readable medium can be stored on any suitable computer readable media such as RAMs, ROMs, flash memory, EEPROMs, optical devices (CD or DVD), hard drives, floppy drives, or any suitable device. The computer-executable component can be a processor but any suitable dedicated hardware device can (alternatively or additionally) execute the instructions”), cause the processing circuitry to:
receive tracking information associated with a patella detected by at least one tracking element
determine patella information based on the tracking information (corresponding disclosure in at least [0041], where there is a tracking device that determines patella information “The surgeon may attach an IMU or other tracking device to the patella during surgery such that the system can detect the trajectory of the patella relative to the trochlea upon articulation of the patient's knee joint”),
the patella information indicating at least one characteristic of the patella (corresponding disclosure in at least [0041], where a characteristic of the patella is included (trajectory) “The surgeon may attach an IMU or other tracking device to the patella during surgery such that the system can detect the trajectory of the patella relative to the trochlea upon articulation of the patient's knee joint”),
generate a patella model configured as a virtual representation of the patella configured based on the patella information (corresponding disclosure in at least [0029], where there is a patella model generated “the system can generate a postoperative patient-specific model of a patient's knee joint region further including a femoral component model, a tibial component model, and/or a patellar component model”), and
present a graphical user interface (GUI) object visually depicting the patella model on a GUI screen via the display device (corresponding disclosure in at least [0015], where there is a patella model generated “the system can receive an implant selection from a surgeon via a surgeon portal (e.g., a graphical user interface). After the implant has been designated, the system can access a 3D model of the femoral, tibial, and/or patellar components of the implant”), wherein the patella model is configured to be used in a surgical operation involving the patella (corresponding disclosure in at least [0027], where the model is used in surgical operation “to align a generic tissue model to patient scan data; to locate one or more implant models, surgical tools, surgical guides, surgical fasteners, etc. relative to the patient's scan data or relative to an object in a patient-specific tissue model; and/or to define a cut plane or a cutting tool trajectory for an upcoming surgery”).
Amanatullah ‘729 does not teach information including dimensions of the patella.
Amanatullah ‘398 in a similar field of endeavor, teaches a similar concept (tracking of patella) of information including dimensions of the patella (corresponding disclosure in at least [0034], where the information of the dimensions of the patella are determined “ the computer system transforms pre-operative scan data (e.g., MRI scans, orthogonal X-rays images, and/or CT scans) of a hard tissue of interest into a virtual patient model representing the hard tissue of interest. For example, the computer system can access an MRI scan of a patient's left leg, including dimensionally-accurate details of bones (e.g., a femur and a tibia), tendons (e.g., a patellar tendon)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated information regarding the dimensions of the patella as taught by Amanatullah ‘398. One of the ordinary skill in the art would have been motivated to incorporate this because keeping track of the dimensions of the patella is beneficial in planning accurate surgical procedures.
Regarding Claim 15, Amanatullah ‘729 and Amanatullah ‘398 teach the limitations of Claim 10, and Amanatullah ‘729 further teaches wherein the tracking information comprises a cutting plane associated with the patella (corresponding disclosure in at least [0056], where the system tracks the cutting plane (cutting tool trajectory) of the patella “The system can similarly define cutting tool trajectories (e.g., “cut paths”) relative to the femur and tibia in the patient-specific knee joint model that, when executed with a real surgical saw, yield bone removal sufficient to achieve the foregoing target femoral, tibial, and patellar component positions”).
Regarding Claim 17,
Amanatullah ’729 teaches a method comprising: receiving tracking information associated with a patella detected by at least one tracking element (corresponding disclosure in at least [0041], where there is a tracking device that determines patella information “The surgeon may attach an IMU or other tracking device to the patella during surgery such that the system can detect the trajectory of the patella relative to the trochlea upon articulation of the patient's knee joint”);
determining patella information based on the tracking information, the patella information indicating at least one characteristic of the patella (corresponding disclosure in at least [0041], where a characteristic of the patella is included (trajectory) “The surgeon may attach an IMU or other tracking device to the patella during surgery such that the system can detect the trajectory of the patella relative to the trochlea upon articulation of the patient's knee joint”),
generating a patella model configured as a virtual representation of the patella configured based on the patella information (corresponding disclosure in at least [0029], where there is a patella model generated “the system can generate a postoperative patient-specific model of a patient's knee joint region further including a femoral component model, a tibial component model, and/or a patellar component model”); and
presenting a graphical user interface (GUI) object visually depicting the patella model on a GUI screen via the display device (corresponding disclosure in at least [0015], where there is a patella model generated “the system can receive an implant selection from a surgeon via a surgeon portal (e.g., a graphical user interface). After the implant has been designated, the system can access a 3D model of the femoral, tibial, and/or patellar components of the implant”), wherein the patella model is configured to be used in a surgical operation involving the patella (corresponding disclosure in at least [0027], where the model is used in surgical operation “to align a generic tissue model to patient scan data; to locate one or more implant models, surgical tools, surgical guides, surgical fasteners, etc. relative to the patient's scan data or relative to an object in a patient-specific tissue model; and/or to define a cut plane or a cutting tool trajectory for an upcoming surgery”).
Amanatullah ‘729 does not teach information including dimensions of the patella.
Amanatullah ‘398 in a similar field of endeavor, teaches a similar concept (tracking of patella) of information including dimensions of the patella (corresponding disclosure in at least [0034], where the information of the dimensions of the patella are determined “ the computer system transforms pre-operative scan data (e.g., MRI scans, orthogonal X-rays images, and/or CT scans) of a hard tissue of interest into a virtual patient model representing the hard tissue of interest. For example, the computer system can access an MRI scan of a patient's left leg, including dimensionally-accurate details of bones (e.g., a femur and a tibia), tendons (e.g., a patellar tendon)”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated information regarding the dimensions of the patella as taught by Amanatullah ‘398. One of the ordinary skill in the art would have been motivated to incorporate this because keeping track of the dimensions of the patella is beneficial in planning accurate surgical procedures.
Claims 11-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Amanatullah ‘729 (US20200383729A1) and Amanatullah ‘398 (US20200405398A1) as applied in claim 10 and in further view of Hampp (US20190209187A1).
Regarding Claim 11, Amanatullah ‘729 and Amanatullah ‘398 teach the limitations of Claim 10 and the processing circuitry ([0098] of Amanatullah ‘729), but does not teach to receive instrument tracking information corresponding to a surgical instrument associated with a tracking patella clamp, the instrument tracking information detected by the at least one tracking element.
Hampp, in a similar field of endeavor, teaches a similar concept (tracking in regard to the patella) of receiving instrument tracking information corresponding to a surgical instrument associated with a tracking patella clamp, the instrument tracking information detected by the at least one tracking element (corresponding disclosure in at least [0009], where the tracking of the instrument is associated with the tracking patella clamp “There is a correlation between the patella clamp and the registration tracker instrument. During preoperative planning, the positioning of the patella clamp must be determined to ensure its placement is below the resection plane or level” and further in [0010], where there is a tracking element that detects the information “Once the patella is registered, the system knows the position of the patella relative to the tracker housed on the patella clamp”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated receiving tracking information of an instrument associated with the clamp through a tracking element as taught by Hampp. One of the ordinary skill in the art would have been motivated to incorporate this because the tracking of the instrument alongside the clamp provides proper orientation and location information of the tools prior to resectioning of the patella.
Regarding Claim 12, Amanatullah ‘729 and Amanatullah ‘398 teach the limitations of Claim 11 and the processing circuitry ([0098]), but does not teach to determine instrument information of the surgical instrument based on the instrument tracking information, the instrument information comprising at least one of a position or an orientation of the surgical instrument.
Hampp, in a similar field of endeavor, teaches (corresponding disclosure in at least [0048], where the position/orientation of the instrument is determined, which is completed based on the multiple trackers in place on the clamp “Tracker 460 may be engaged to tracker post in at least four positions with respect to a longitudinal axis L3 of tracker post 440. Each of the four positions are separated preferably 90° about the longitudinal axis of tracker post 440”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated determining information of the surgical instrument based on the tracking information as taught by Hampp. One of the ordinary skill in the art would have been motivated to incorporate this because understanding the position or orientation of the surgical instrument provides proper orientation and location information of the tools prior to resectioning of the patella.
Regarding Claim 13, the combined references noted above teach the limitations of Claim 12 and Amanatullah ‘729 further teaches the instructions, when executed by the processing circuitry, to cause the processing circuitry to present a GUI model of the surgical instrument on the GUI screen based on the instrument information (corresponding disclosure in at least [0056], where there is a model of the surgical instrument displayed (cutting tool animated) “The system can thus serve the patient-specific knee joint model—with the cut planes and/or with a cutting tool animated along the cutting tool trajectories in the patient-specific knee joint model—to the surgeon through the surgeon portal”).
Regarding Claim 16, Amanatullah ‘729 and Amanatullah ‘398 teach the limitations of Claim 10, but does not teach the at least one tracking element is coupled to a tracking patella clamp engaging the patella.
Hampp, in a similar field of endeavor, teaches wherein the at least one tracking element is coupled to a tracking patella clamp engaging the patella (corresponding disclosure in at least [0011], where the tracker is coupled to the clamp “The surgical system may include a tracking system communicatively coupled to at least one tracker coupled to the tracking patella clamp”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated coupling the tracking element to the patella clamp engaging the patella as taught by Hampp. One of the ordinary skill in the art would have been motivated to incorporate this because the clamp engaging the patella can then be tracked for the surgeon to reposition as necessary during surgical procedures.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Amanatullah ‘729 (US20200383729A1), Amanatullah ‘398 (US20200405398A1) and Hampp (US20190209187A1) as applied in Claim 11 and in further view of Odermatt (US20180199995A1).
Regarding Claim 14, the combined references above teach the limitations of Claim 11, and the surgical instrument ([0027] of Amanatullah ’729) but do not teach wherein the surgical instrument comprises a reamer tool.
Odermatt, in a similar field of endeavor, teaches a similar concept (surgical planning) of a reamer tool (corresponding disclosure in at least [0061], where the surgical tool is a reamer “the surgeon resurfaces the acetabulum 22 using a reamer and replaces the natural surface with a prosthetic acetabular component”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a reamer tool as taught by Odermatt. One of the ordinary skill in the art would have been motivated to incorporate this because reamer tools are commonly used during surgical procedures for precise cutting and creating holes.
Response to Arguments
Applicant's arguments filed 04/14/2026 regarding the 35 U.S.C. 101 rejection have been fully considered but they are not persuasive. The addition of “wherein the patella model is configured to be used in a surgical operation involving the patella” does not further limit the claim by adding limitations for the “treatment”. Merely reciting that the patella model is being used in a surgical operation does not remove the claim from being a nonabstract idea (see office action above and MPEP § 2106.05(h)). Dependent claims 14 and 16 may be considered overcome with additional structural limitations added to the claims. However, the current functional capabilities do not place the claims as overcoming the current 35 U.S.C. 101 rejections.
Applicant's arguments filed 04/14/2026 regarding the 35 U.S.C. 112b rejection have been fully considered and are withdrawn in light of the amendments.
Applicant’s arguments regarding the 35 U.S.C 102 and 103 rejections 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
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.
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/K.E.K./ Examiner, Art Unit 3797
/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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