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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The term “optimally” used in claim 1 is generic and lacks definition/boundaries.
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 1-10 and 13-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to
abstract idea without significantly more.
Step 1
Claims 1-10 and 13-21 are within the four statutory categories. However, as will be shown below, claims 1-10 and 13-21 are nonetheless unpatentable under 35 U.S.C. 101.
Claim 1 is representative of the inventive concept and recites:
A surgical system, comprising: at least one computing device, comprising:
processing circuitry;
and a memory coupled to the processing circuitry, the memory storing data associated with a patient, and an implant model comprising an interface element, the memory comprising instructions that, when executed by the processing circuitry, may cause the processing circuitry to:
generate, based on at least the data associated with the patient, a three-dimensional (3D) virtual anatomical model comprising an interface region, the 3D virtual anatomical model being associated with a portion of the patient's anatomy;
generate a constraint model, by mapping a 3D volume of the interface region to define a 3D constraint space within the interface region of the 3D virtual anatomical model, the 3D constraint space being operative to confine a movement of the interface element, associated with the implant model, within the interface region of the 3D virtual anatomical model, in accordance to at least one valid configuration for optimally fitting the interface element of the implant model within the interface region of the 3D virtual anatomical model;
generate a surgical planning graphical user interface (GUI) comprising a model user interface (UI), the model UI comprising: a visual representation of the implant model with the interface element a visual representation of the 3D virtual anatomical model with the interface region for engaging the interface element of the implant model, the interface region comprising: a visual representation of the 3D constraint space, rendered within the interface region: and one or more validity indicators as dynamic graphical objects overlaying one or more portions of the 3D constraint space.
Step 2A Prong One
The broadest reasonable interpretation of these steps includes mental processes because the
highlighted components can practically be performed by the human mind (in this case, the process of
generating) or using pen and paper. Other than reciting generic computer components/functions such as “system”, “computing device”, “processing circuitry”, and “memory coupled to the processing circuitry”, nothing in the claims precludes the highlighted portions from practically being performed in the mind. For example, in claim 1, but for the generic computer language, the claim encompasses the user determining a plan and following the plan for a medical procedure. If a claim limitation, under its broadest reasonable interpretation, cover performance of the limitation in the mind but for the recitation of generic computer components/functions, then it falls within “Mental Processes” grouping of abstract ideas. Additionally, the mere nominal recitation of a generic computer does not take the claim limitation out of the mental process grouping. Thus, the claim recites a mental process. The highlighted portion, specifically the model, under its broadest reasonable interpretation can also fall under “Mathematical concepts” because the model relates to mathematical relationships, mathematical formulas or equations, mathematical calculations. MPEP § 2106.04(a)(2)(I). The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes.
Step 2A Prong Two
This judicial exception is no integrated into a practical application. In particular, the claims recite the
following additional limitations:
Claim 1 recites: “system”, “computing device”, “processing circuitry”, “memory coupled to the processing circuitry”, “virtual”, and “graphical user interface (GUI)” and “user interface (UI)”
In particular, the additional elements do no integrate the abstract idea into a practical application, other
than the abstract idea per se, because the additional elements amount to no more than limitations which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations
are recited as being performed by a “system”, “computing device”, “processing circuitry”, “memory coupled to the processing circuitry”, and “model”. A computer is recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer.
Add insignificant extra-solution activity (MPEP 2106.05(g)) to the abstract idea such as the
recitation of “virtual”, “graphical user interface (GUI)” and “user interface (UI)”.
Dependent claims 4-10 and 13-20 recite model
Dependent claims 9 and 10 recite device
Dependent claim 19 recites GUI
Dependent claim 21 recites transmitted and stored
In particular, the additional elements do no integrate the abstract idea into a practical application, other
than the abstract idea per se, because the additional elements amount to no more than limitations which:
Amount to mere instructions to apply an exception (MPEP 2106.05(f)). The limitations
are recited as being performed by a “device” and “model”. A computer is recited at a high level of generality and amounts to no more than mere instructions to apply the exception using a generic computer.
Add insignificant extra-solution activity (MPEP 2106.05(g)) to the abstract idea such as the
recitation of “GUI”, “transmitted”, and “stored”.
Dependent claims 2 and 3 do not include any additional elements beyond those already recited in independent claim 1 or dependent claims 4-10 and 13-21, hence do not integrate the aforementioned abstract idea into a practical application. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or any other technology. Their collective function merely provides conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
Step 2B
Claim 1 does not include additional elements that are sufficient to amount to significantly
more than the judicial exception. As discussed above with respect to discussion of integration of the
abstract idea into a practical application, the additional elements: A system in claim 1; amount to no
more than mere instructions to apply an exception to the abstract idea. Additionally, the additional
limitations, other than the abstract idea per se amount to no more than limitations which amount to
elements that have been recognized as well-understood, routine, and conventional activity in particular
fields as demonstrated by the recitation of an additional element such as:
Virtual, which expressly means to be carried out, accessed, or stored by means of a computer (Para 0071, Levendowski(US-20180333558-A1) discloses: “Such methods may include augmented reality (e.g., overlaying any of the visual elements described herein over a real-time image of the user's physical environment), virtual reality (e.g., providing a virtual universe in which the user can move and with which the user can interact using conventional virtual reality gear, such as a headset, hand paddles, etc.), and/or the like.”) in a manner that is well-understood, routine, and conventional.
Graphical user interface (GUI)/UI, which refers to a visual way of interacting with a computer (Para 0040, Mann(US 20180357914 A1) discloses: “A conventional GUI display includes a desktop metaphor upon which one or more icons, application windows, or other graphical objects are displayed.”) in a manner that is well-understood, routine, and conventional.
Transmitted, which refers to the process of sending digital information between devices over a communication channel using a signal (TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 614, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016)) in a manner that is well-understood, routine, and conventional.
Storing, which refers to the process of recording digital information on physical or virtual media (Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015) in a manner that is well-understood, routine, and conventional.
Dependent claims 2 and 3 do not include any additional elements beyond those already
addressed above for independent claim 1 or dependent claims 4-10 and 13-21. Therefore, they are not deemed to be significantly more than the abstract idea because, as stated above, the limitations of the aforementioned dependent claims amount to no more than generally linking the abstract idea to a particular technological environment or field of use, and/or do not recite and additional elements not already recited in independent claim 1, hence does not amount to “significantly more” than the abstract idea. Thus, taken alone, the additional elements do not amount to significantly more than the abstract idea identified above. Furthermore, looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually, and there is no indication that the combination of elements improves the functioning of a computer or improves any other technology, and their collective function merely provide conventional computer implementation.
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 1-6, 8-10 and 13-19 are rejected under 35 U.S.C. 103 as being unpatentable over Otto(WO2010068212A1) in view of Metzger(US20100087829A1) and Bellettre(US20190117311A1).
Claim 1
Otto discloses:
A surgical system, comprising:
at least one computing device, comprising: processing circuitry(Para 0046, Otto discloses a processor based system); and a memory coupled to the processing circuitry(Para 0046, Otto discloses memory), the memory storing data associated with a patient,
generate, based on at least the data associated with the patient, a three-dimensional (3D) virtual(Para 00119, Otto discloses a virtual environment)
generate a constraint model(Figure 4A, Para 0060, Otto discloses constraints in the constraint model represent limits), by mapping a 3D volume of the interface region to define a 3D constraint space(Para 0052, Otto discloses: “Constraints can be associated with points, axes, lines, volumes[VOLUME- CAN BE CONSIDERED CONSTRAINT SPACE-VOLUME IS ALSO INHERENTLY 3-DIMENSIONAL], and/or other constraints.”) within the interface region of the 3D virtual anatomical model, the 3D constraint space being operative to confine a movement of the (Para 0011, Otto discloses the generation of a display representing bone and a representation of an implant meant for a specific patient), (Para 0060, Otto discloses: “If the system 100 determines the positioning does not violate the positioning constraint, the system 100 allows (214) the new positioning.”) the
Otto does not explicitly disclose:
interface element
interface region
the 3D virtual anatomical model being associated with a portion of the patient's anatomy
generate a surgical planning graphical user interface (GUI) comprising a model user interface (UI), the model UI comprising: a visual representation of the implant model with the interface element a visual representation of the 3D virtual anatomical model with the interface region for engaging the interface element of the implant model, the interface region comprising: a visual representation of the 3D constraint space, rendered within the interface region: and one or more validity indicators as dynamic graphical objects overlaying one or more portions of the 3D constraint space
Metzger discloses:
anatomical model comprising an interface region(Figure 8, Metzger discloses a 3D model comprising an interface region where prosthesis is attached (602a))
the 3D virtual anatomical model being associated with a portion of the patient's anatomy(Figure 8, Metzger discloses a 3D model of a portion of the patient anatomy)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add anatomical model comprising and interface region, and 3D virtual anatomical model being associated with a portion of the patient's anatomy, as taught by Metzger. One of ordinary skill would have been so motivated to define a region where an implant and the patient anatomy interact, to better enable patient outcomes for surgical procedures, but in this case, for a patient-specific knee alignment guide (Para 0002, Metzger discloses: “Proper alignment of prosthetic components in knee arthroscopy is an important factor in the longevity and function of the implant. Misalignment can cause increased wear of the implant, patient discomfort, and functional limitation.”).
Metzger does not explicitly disclose:
interface element
generate a surgical planning graphical user interface (GUI) comprising a model user interface (UI), the model UI comprising: a visual representation of the implant model with the interface element a visual representation of the 3D virtual anatomical model with the interface region for engaging the interface element of the implant model, the interface region comprising: a visual representation of the 3D constraint space, rendered within the interface region: and one or more validity indicators as dynamic graphical objects overlaying one or more portions of the 3D constraint space
Bellettre discloses:
interface element
generate a surgical planning graphical user interface (GUI)(Para 0047, Bellettre discloses a GUI) comprising a model user interface (UI)(Para 0184, Bellettre discloses a visual interface which can be a model user interface), the model UI comprising: a visual representation of the implant model with the interface element(Figure 2, Bellettre discloses an interface element) a visual representation of the 3D virtual anatomical model(FIGS 4A-4B and Para 0185, Bellettre discloses a 3-dimensional display) with the interface region for engaging the interface element of the implant model, the interface region comprising: a visual representation of the 3D constraint space(Para 0185, Bellettre discloses a display device to visualize constraint space), rendered within the interface region: and one or more validity indicators(Para 0186, Bellettre discloses the display of status information which can include validity indicators) as dynamic graphical objects overlaying one or more portions of the 3D constraint space(Para 0052, Bellettre discloses a display to allow positioning of multiple representations to understand relationship among components and bones)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add interface element, generate a surgical planning graphical user interface (GUI) comprising a model user interface (UI), the model UI comprising: a visual representation of the implant model with the interface element a visual representation of the 3D virtual anatomical model with the interface region for engaging the interface element of the implant model, the interface region comprising: a visual representation of the 3D constraint space, rendered within the interface region: and one or more validity indicators as dynamic graphical objects overlaying one or more portions of the 3D constraint space, as taught by Bellettre. One of ordinary skill would have been so motivated to be able to provide visual indication of placement according to a surgical plan to improve patient outcomes, but in this case, for implant planning (Para 0008, Bellettre discloses: “a need exists for surgical methods and devices which can overcome the aforementioned problems so as to enable intraoperative implant planning for accurate placement and implantation of multiple joint implant components providing improved joint performance; consistent, predictable operative results regardless of surgical skill level; sparing healthy bone in minimally invasive surgery; achieving a fit of the implant components that address each patient's unique anatomy, ligament stability, and kinematics; and reducing the need for replacement and revision surgery.”).
Claim 2
Otto discloses:
The surgical system of claim 18, the instructions, when executed by the processing circuitry, to cause the processing circuitry to generate at least one indicator indicating a violation responsive to the violation event. (Para. 0052, Figure 3, #102, Otto discloses prevent operator from improper location)
Claim 3
Otto discloses:
The surgical system of claim 2, the at least one indicator comprising at least one of an overlay, a color, a pattern, an alert, an alarm, a message, or a tactile signal. (Para. 0052, Otto discloses prevent operator from improper location, error message Fig. 3, #102,#106)
Claim 4
Otto discloses:
The surgical system of claim 18, the violation event process operative to prevent placement input moving the implant into a position that violates the constraint model. ( Para. 0052, Otto discloses prevent operator from improper location)
Claim 5
Otto discloses:
The surgical system of claim 18, the violation event process operative to prevent user input that violates the constraint model via limiting parameter values that violate the constraint model. (Para. 0052, Otto discloses prevent operator from improper location and Fig. 3)
Claim 6
Otto discloses:
The surgical system of claim 1, wherein the movement of the implant model is bound within a portion of the (Para. 0052, Otto discloses prevent operator from improper location)
Otto does not disclose:
interface region
Metzger discloses:
interface region(Figure 8, Metzger discloses a 3D model comprising an interface region)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add interface region, as taught by Metzger. One of ordinary skill would have been so motivated to define a region where an implant and the patient anatomy interact, to better enable patient outcomes for surgical procedures, but in this case, for a patient-specific knee alignment guide (Para 0002, Metzger discloses: “Proper alignment of prosthetic components in knee arthroscopy is an important factor in the longevity and function of the implant. Misalignment can cause increased wear of the implant, patient discomfort, and functional limitation.”).
Claim 8
Otto discloses:
The surgical system of claim 1, the constraint model configured for an arthroplasty surgical procedure. ( Para. 0002, Otto discloses surgical procedure)
Claim 9
Otto discloses:
The surgical system of claim 8, the 3D virtual anatomical model comprising at least a portion of a distal femur configured to receive a femoral component knee implant device. (Para. 0049, Otto discloses central patella femoral implant component with respect to the representation of the femur)
Claim 10
Otto discloses:
The surgical system of claim 8, the 3D virtual anatomical model comprising at least a portion of a proximal tibia configured to receive a tibial knee implant device. (Para. 0086, Otto discloses tibial onlay)
Claim 13
Otto discloses:
The surgical system of claim 1, the at least one valid configuration comprising at least one of an anatomical fit or a performance criterion(Para. 0050, Otto discloses 2 or 3d model having multiple shapes and sizes for finding best fit ) of the implant model in association with the 3D virtual anatomical model.
Claim 14
Otto discloses:
The surgical system of claim 1, the constraint model configured to model at least one degree-of-freedom of an implant, the at least one degree-of-freedom comprising at least one of a varus/valgus angle, a flexion/extension position, a medial/lateral position, or an anterior/posterior position (Para. 0079 – 0086, Otto discloses with regards to constraints, positioning medial and lateral)
Claim 15
Otto discloses:
The surgical system of claim 1, the constraint model generated to correspond to surgically-prepared patient anatomy. (Para. 0051, Otto discloses position implant component representation based on representation of bone)
Claim 16
Otto discloses:
The surgical system of claim 1, the 3D virtual anatomical model comprising the interface region for engaging the (Para. 0073 and Fig. 7, Otto discloses positioning an implant based on optimum placement and positioning ).
Otto and Metzger do not explicitly disclose:
interface element
Bellettre discloses:
interface element(Figure 2, Bellettre discloses interface elements of an implant model)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add interface element, as taught by Bellettre. One of ordinary skill would have been so motivated to be able to provide a defined area on an implant to interact with patient anatomy, to better improve execution of a surgical plan, but in this case, for implant planning (Para 0008, Bellettre discloses: “a need exists for surgical methods and devices which can overcome the aforementioned problems so as to enable intraoperative implant planning for accurate placement and implantation of multiple joint implant components providing improved joint performance; consistent, predictable operative results regardless of surgical skill level; sparing healthy bone in minimally invasive surgery; achieving a fit of the implant components that address each patient's unique anatomy, ligament stability, and kinematics; and reducing the need for replacement and revision surgery.”).
Claim 17
Otto discloses:
The surgical system of claim 16, the interface region of the 3D virtual anatomical model comprising an intramedullary (IM) canal interface, the (Para 0052, Otto discloses: “Constraints can be associated with points, axes, lines, volumes[VOLUME- CAN BE CONSIDERED CONSTRAINT SPACE], and/or other constraints.”).
Otto and Metzger do not explicitly disclose:
interface element
Bellettre discloses:
interface element(Figure 2, Bellettre discloses interface elements of an implant model)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add interface element, as taught by Bellettre. One of ordinary skill would have been so motivated to be able to provide a defined area on an implant to interact with patient anatomy, to better improve execution of a surgical plan, but in this case, for implant planning (Para 0008, Bellettre discloses: “a need exists for surgical methods and devices which can overcome the aforementioned problems so as to enable intraoperative implant planning for accurate placement and implantation of multiple joint implant components providing improved joint performance; consistent, predictable operative results regardless of surgical skill level; sparing healthy bone in minimally invasive surgery; achieving a fit of the implant components that address each patient's unique anatomy, ligament stability, and kinematics; and reducing the need for replacement and revision surgery.”).
Claim 18
Otto discloses:
The surgical system of claim 1, the instructions, when executed by the processing circuitry, to cause the processing circuitry to: receive placement input indicating placement of the implant model in association with the 3D virtual anatomical model(Disclosed by Otto in Para. 0033, Para. 0051 and Fig. 3 - #208), and perform, based on the placement input one of: a violation process based on a violation event responsive to the placement input violating the constraint model(Otto discloses in Para. 0059, Fig. 3-# 210 and #212, constraints act as automatic guides for positioning), or a placement process positioning the implant according to the placement input responsive to the placement input not violating the constraint model(Otto discloses violation in Para. 0063 and Fig. 3, #214).
Claim 19
Otto discloses:
The surgical system of claim 1, wherein the surgical planning GUI comprises one or more optimization functions for optimizing placement of the (Para. 0073 and Fig. 7, Otto discloses positioning an implant based on optimum placement and positioning ).
Otto and Metzger do not explicitly disclose:
interface element
Bellettre discloses:
interface element(Figure 2, Bellettre discloses interface elements of an implant model)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add interface element, as taught by Bellettre. One of ordinary skill would have been so motivated to be able to provide a defined area on an implant to interact with patient anatomy, to better improve execution of a surgical plan, but in this case, for implant planning (Para 0008, Bellettre discloses: “a need exists for surgical methods and devices which can overcome the aforementioned problems so as to enable intraoperative implant planning for accurate placement and implantation of multiple joint implant components providing improved joint performance; consistent, predictable operative results regardless of surgical skill level; sparing healthy bone in minimally invasive surgery; achieving a fit of the implant components that address each patient's unique anatomy, ligament stability, and kinematics; and reducing the need for replacement and revision surgery.”).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Otto(WO2010068212A1) in view of Metzger(US20100087829A1), and Bellettre(US20190117311A1), and Stein(US20140134586A1).
Claim 20
Otto and Metzger do not explicitly disclose:
The surgical system of claim 1, the instructions, when executed by the processing circuitry, to cause the processing circuitry to: automatically update the one or more validity indicators in real time, responsive to one or more placement inputs received from one or more of a user and a tracked surgical instrument, to distinguish valid and invalid positions of the interface element, associated with the implant model, within the 3D constraint space integrated within the interface region of the 3D virtual anatomical model.
Bellettre discloses:
automatically update the one or more validity indicators in real time(Para 0061, Bellettre discloses updating the display to reflect new positioning and an error message as a validity indicator)
to distinguish valid and invalid positions(Para 0061, Bellettre discloses updating the display to reflect new positioning and an error message which indicates an invalid position)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add automatically update the one or more validity indicators in real time and to distinguish valid and invalid positions, as taught by Bellettre. One of ordinary skill would have been so motivated to be able to provide visual indication of placement according to a surgical plan to improve patient outcomes, but in this case, for implant planning (Para 0008, Bellettre discloses: “a need exists for surgical methods and devices which can overcome the aforementioned problems so as to enable intraoperative implant planning for accurate placement and implantation of multiple joint implant components providing improved joint performance; consistent, predictable operative results regardless of surgical skill level; sparing healthy bone in minimally invasive surgery; achieving a fit of the implant components that address each patient's unique anatomy, ligament stability, and kinematics; and reducing the need for replacement and revision surgery.”).
Bellettre does not explicitly disclose:
responsive to one or more placement inputs received from one or more of a user and a tracked surgical instrument
Stein discloses:
responsive to one or more placement inputs received from one or more of a user and a tracked surgical instrument(Figure 5, Stein discloses a tracked surgical instrument)
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add responsive to one or more placement inputs received from one or more of a user and a tracked surgical instrument, as taught by Stein. One of ordinary skill would have been so motivated to be able to track implant placement according to a surgical plan to improve patient outcomes, but in this case, for a GUI used for orthopedic tool position and trajectory(Para 0005, Stein discloses: “Even with templating, trialing, and advanced prosthetic components, outcomes including functional efficacy, patient comfort, and longevity of the prosthesis may not always be highly predictable, especially if procedures are performed by physicians and surgeons with different levels of skill, experience, and frequency of repeating an individual procedure.”).
Claims 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Otto(WO2010068212A1) in view of Metzger(US20100087829A1), and Bellettre(US20190117311A1), and Haddad(US8265949B2).
Claim 21
Otto, Metzger, and Bellettre do not explicitly disclose:
The surgical system of claim 7, wherein the surgical plan is stored and transmitted for execution by a computer-assisted surgical system.
Haddad discloses:
The surgical system of claim 7, wherein the surgical plan is stored and transmitted for execution by a computer-assisted surgical system(Figure 1 Haddad discloses storage of a surgical plan and transmission to a computer assisted surgery system).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add surgical plan is stored and transmitted for execution by a computer-assisted surgical system, as taught by Haddad. One of ordinary skill would have been so motivated to be able to create and store surgical plans for execution to better enable traceability and accuracy for surgical procedures, but in this case, for a customized patient surgical plan (Para 0005, Haddad discloses: “Moreover, typical CAOS systems require a surgeon to enter considerable amount of data and other responses in order to configure, calibrate and/or drive the system during the surgical procedure.“).
Claim 7
Otto does not explicitly disclose:
The surgical system of claim 1, the instructions, when executed by the processing circuitry, to cause the processing circuitry to generate a surgical plan determined based on a configuration of the interface element, associated with the implant model within the 3D constraint space defined by the constraint model, wherein the surgical plan is associated with the patient.
Metzger discloses:
The surgical system of claim 1, the instructions, when executed by the processing circuitry, to cause the processing circuitry to generate a surgical plan determined based on a configuration of the implant model within the constraint model(Para 0070, Metzger discloses the generation of a surgical plan on the basis of scan data (MRI and CT)).
Before the effective filing date of the claimed invention, it would have been obvious to one of
ordinary skill in the art to have modified the implant planning for multiple implant components using constraints of Otto to add to generate a surgical plan determined based on a configuration of the implant model within the constraint model, as taught by Metzger. One of ordinary skill would have been so motivated to be able to automatically determine an accurate surgical plan using an existing constraint model of a patient, but in this case, for a patient-specific knee alignment guide (Para 0002, Metzger discloses: “Proper alignment of prosthetic components in knee arthroscopy is an important factor in the longevity and function of the implant. Misalignment can cause increased wear of the implant, patient discomfort, and functional limitation.”).
Response to Arguments
Rejection under 35 U.S.C. 101
(Page 7) Regarding the assertion that amended claim 1 provides a specific technological improvement.
Applicant's arguments filed have been fully considered but they are not persuasive. There is no indication that the combination of elements improves the functioning of a computer or any other technology. Their collective function merely provides conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
(Page 9) Regarding the assertion that the claims describe specifically how the constraint modeling is implemented to yield the desired outcome and improvements described in the specification.
Applicant's arguments filed have been fully considered but they are not persuasive. In the example provided on pages 9 and 10, there is no technical detail on how the optimization, implementation, and characterization occurs, so the actions remain abstract.
(Page 11) Regarding the assertion that even if pen and paper is used to indicate arrow and colors with respect to the anatomical model, pen and paper cannot be used to generate a virtual anatomical model.
Applicant's arguments filed have been fully considered but they are not persuasive. Pen and paper can be used to generate a virtual anatomical model.
(Page 11) Regarding the assertion that pen and paper cannot be used to integrate an active 3D constraint space to facilitate simulations between interface regions.
Applicant's arguments filed have been fully considered but they are not persuasive. The claims recite no indication of an active 3D constraint space, nor what an active 3D constraint space entails.
(Pages 12-13) Regarding the assertion that the claimed subject matter is not abstract mathematics or mental reasoning.
Applicant's arguments filed have been fully considered but they are not persuasive. The claims recite no indication of the models being rooted in CAD-based surgical technology or a visual framework based on technology. In regards to the court findings in support of visual interface improvements, the patent references a GUI which actively displays. There is no indication in the claims of a displaying function related to the GUI, but mere generation of a GUI “concept” when the claims are interpreted under BRI.
(Pages 14) Regarding the assertion that the recited limitations cannot be reasonably characterized as mental processes.
Applicant's arguments filed have been fully considered but they are not persuasive. The underlined technical justification on page 14 is not found in the claims and is recited broadly in a manner that indeed can be characterized as a mental process
Rejection under 35 U.S.C. 103
Applicant’s arguments with respect to claim(s) 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.
Mahfouz(US12115074B2): Mahfouz discloses a method of reconstructing an implant by comparing patient-specific abnormal bone model with a reconstructed bone model. Some disclosures of this invention are similar to that of this instant pending application. (Specifications, Para 0093-0099)
Schroeder(US8457930B2): Schroeder discloses a method related to medical implants and surgical instruments produced to precisely fit individual subjects. Some disclosures of this invention are similar to that of this instant pending application. (Specifications, Para 0093-0099)
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).
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/S.G.P./Examiner, Art Unit 3685
/KAMBIZ ABDI/Supervisory Patent Examiner, Art Unit 3685