DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 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.
Claims 1-23 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0324114 (Hurley) in view of U.S. Patent Application Publication No. 2018/0303552 (Ryan).
Regarding claim 1, Hurley discloses a computer-implemented method (see Abstract and paragraph [0047]) comprising: displaying, via a surgery planner graphical user interface (GUI) on at least one user device, a personalized surgical plan that includes a first image of a planned corrected anatomy of a patient achieved using a first implant (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C; plate implant displayed on an anatomical image); sending, from the at least one user device, first user input for the personalized surgical plan, wherein the first user input is inputted via the surgery planner GUI (see paragraphs [0094]-[0096]; user manipulating the plate in the image); displaying, via the surgery planner GUI on the at least one user device, a modified personalized surgical plan generated by a digital implant design platform based on the first user input (see paragraphs [0094]-[0096]; user interface displays image with plate adjusted based on user input), wherein the modified personalized surgical plan includes a second image of a second implant and a modified planned corrected anatomy achieved using the second implant, wherein the second implant is different from the first implant (see paragraphs [0094]-[0096]; user interface displays modified image based on plate adjusted by user input on corrected anatomy).
Further regarding claim 1, Hurley is silent regarding wherein the digital implant design platform is configured to be trained using data obtained from a training database of the digital implant design platform. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to be trained using data obtained from a training database of the platform (see paragraphs [0055], [0056], [0100], [0173], and [0209]-[0234]). Regarding claim 3, Ryan discloses wherein the digital implant design platform is programmed to perform training for generating patient-specific surgical plans (see paragraphs [0209]-[0221]). Regarding claim 11, Ryan discloses wherein the data obtained from the training database includes images of subjects (see paragraphs [0007], [0012], [0017], and [0209]-[0221]), wherein the digital implant design platform includes at least one of a neural network trained using at least some of the images of subjects and scored surgery outcomes; or a machine learning model trained to receive a set of the images of subjects and to output one or more implant designs based on the set of the images (see paragraphs [0053], [0071]-[0074], [0099], [0100], [0108], [0116], [0180], [0240]; machine learning model). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to be trained using imaging data from a training database and include a machine learning model as suggested by Ryan in order to have the platform improve its performance though an iterative virtuous cycle by training on datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Further regarding claim 1, Hurley is silent regarding sending, from the at least one user device, second user input for the modified personalized surgical plan, wherein the second user input is inputted via the surgery planner GUI. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract), where the method includes a user sending iteratively sending user input for a modified personalized surgical plan (see Ryan, paragraphs [0056], [0057], [0083], [0084], and [0090]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have a user iteratively send user input for a modified personalized surgical plan that is inputted via the surgery planner GUI in order to allow the user to repeatedly update the surgical plan as needed to create a virtuous cycle in which the surgical plan is improved by iterative user input until a final plan is created to a user’s satisfaction (see Ryan, paragraphs [0056], [0057], [0083], [0084], and [0090]).
Regarding claim 2, Hurley discloses further comprising sending patient data to the digital implant design platform (see paragraph [0048]-[0050]), wherein the digital implant design platform has a module for designing implants (see paragraphs [0010], [0074], [0087], and [0105]). Hurley is silent regarding the platform being programmed to train the module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to train an implant design module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items (see paragraphs [0007], [0012], [0017], [0055], [0056], [0100], [0173], and [0209]-[0234]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to train an implant design module using patient data as suggested by Ryan in order to have the implant design module improve its performance though an iterative virtuous cycle by training on patient datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Further regarding claim 3, Hurley discloses wherein the surgery planner GUI includes one or more anatomical measurements (see paragraph [0060], [0078], and [0082]) and a virtual model of the patient’s anatomy (see paragraphs [0014], [0015], [0041], and [0043]). Hurley is silent on the planner including an implant recommendation, though it does provide implant options (see paragraphs [0060] and [0077]). Additionally, Hurley is silent on the virtual model being of a patient’s spine, though it does provide a virtual model of the patient’s anatomy (see paragraphs [0015], [0015], [0041], and [0043]) and states the methods are applicable to spinal surgery (see paragraph [0112]). Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that includes recommending implants (see paragraphs [0072], [0073], [0110], [0120], [0162], [0164], [0171], and [0181]) and a model of a patient’s spine (see paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the surgery planner of Hurley recommend implants to the user in order to apply machine learning training to analyze patient data and recommend an implant best for the patient based on that analysis (see Ryan, paragraphs [0072], [0073], [0110], [0120], [0162], [0164], [0171], and [0181]). Additionally, it would have been obvious to have the virtual model be of a patient’s spine, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a model of a patient’s spine as part of spinal surgery preoperative planning (see Ryan, paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]).
Regarding claim 4, Hurley discloses further comprising displaying, via the surgery planner GUI, a virtual anatomical model of a portion of a patient (see paragraphs [0008]-[0015], [0050], [0056], and Figs. 11A-16, e.g.), wherein the personalized surgical plan includes virtually positioning of the first implant and/or the second implant along the virtual anatomical model of the portion of the patient (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C; implant displayed on an anatomical image); digitally measured one or more distances (see paragraphs [0060], [0078], and [0094]); one or more user-adjustable dimensions of a virtual implant model of the first implant (see paragraphs [0060], [0078], [0082], [0086], and [0094]-[0096]); output based on the virtual implant model of the first implant implanted along the virtual anatomical model (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C); and receiving, via the surgery planner GUI, user input for interacting with a computer system programmed to design the second implant (see paragraphs [0039], [0047], [0059], [0060], [0079], and [0090]-[0096]).
Further regarding claim 4, Hurley fails to disclose the portion of the patient being a spine. However, Hurley does disclose that its method can be applied to spinal surgery (see paragraph [0112]), and Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that includes a model of a patient’s spine (see paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]). It would have been obvious to have the virtual model be of a patient’s spine, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a model of a patient’s spine as part of spinal surgery preoperative planning (see Ryan, paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]).
Further regarding claim 4, Ryan suggests digitally measuring one or more distances between vertebrae of the spine associated with a spinal deformity of the patient (see paragraphs [0066], [0154], [0158], and [0178]), and it would have been prima facie obvious to modify the method of Hurley to digitally measure distances between vertebrae in order to ensure a proper fit of a spinal implant for a specific patient (see Ryan, paragraphs [0066], [0154], [0158], and [0178]).
Further regarding claim 4, Ryan discloses output from an analysis of the anatomical model based on the implant model of the first implant implanted along the anatomical model (see paragraphs [0053], [0109], [0138], [0152], [0155], [0168]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the personalized surgical plan include output from an analysis of virtual anatomical model in order to ensure the implant is properly designed for a given patient (see Ryan, paragraphs [0053], [0109], [0138], [0152], [0155], [0168]).
Regarding claim 5, Hurley discloses wherein the computer-implemented method further comprises receiving, via the surgery planner GUI, acceptable outcome input from a user (see paragraphs [0008], [0009], [0069], [0072], [0097], and [0106]; user finalizes implant design and sends for 3D printing); and sending, from the at least one user device, the acceptable outcome input for designing the first implant for treating the patient (see paragraphs [0008], [0009], [0045], [0069], [0072], [0075], [0076], [0097], and [0106]; user sends acceptable outcome input for the finalized designed implant for 3D printing/rapid prototyping). Hurley is silent regarding the patient having a spinal deformity and the first implant being a spinal implant. However, Hurley does disclose that its method can be applied to deformity correction and spinal surgery (see paragraph [0112]), and Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that corrects a patient’s spinal deformity with a spinal implant (see paragraphs [0004], [0005], [0051], and [0072]). It would have been prima facie obvious to apply Hurley’s method to treat a spinal deformity with a spinal implant, as Hurley suggests its method is applicable to deformity correction and spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a spinal implant to correct a spinal deformity (see Ryan, paragraphs [0004], [0005], [0051], and [0072]).
Regarding claim 6, Hurley discloses further comprising displaying, via the surgery planner GUI, a design of an implant and anatomy for contacting the implant (see paragraphs [0090]-[0095] and Figs. 14C and 16). Hurley is silent regarding the implant being an intervertebral cage, but does disclose its preoperative planning method is applicable to spinal surgery (see paragraph [0112]). Additionally, Ryan discloses designing an intervertebral cage as part of a preoperative planning method (see paragraphs [0071] and [0116] and Fig. 8, e.g.), and it would be obvious to a person of ordinary skill in the art before the effective filing date of the invention to apply the method of Hurley to an intervertebral cage implant and corresponding surrounding anatomy as suggested by Ryan, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests designing an intervertebral cage as part of spinal surgery preoperative planning (see Ryan, paragraphs [0071] and [0116] and Fig. 8, e.g.).
Regarding claim 7, Hurley discloses further comprising displaying, via the surgery planner GUI, screws positioned in a patient (see paragraph [0014], [0015], [0045], and [0074]). Hurley is silent regarding the screws being positioned in vertebrae of a patient, but does disclose its preoperative planning method is applicable to spinal surgery (see paragraph [0112]). Additionally, Ryan discloses designing vertebral screws as part of a preoperative planning method (see paragraphs [0006], [0009], [0071] and [0166]-[0174] and Fig. 8, e.g.), and it would be obvious to a person of ordinary skill in the art before the effective filing date of the invention to apply the method of Hurley to vertebral screw implant sand corresponding surrounding anatomy as suggested by Ryan, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests designing vertebral screws as part of spinal surgery preoperative planning (see Ryan, paragraphs [0071] and [0166]-[0174] and Fig. 8, e.g.).
Regarding claim 8, Hurley discloses further comprising providing access, via the surgery planner GUI, to viewing of a virtual anatomical model that represents anatomy of the patient (see paragraphs [0008]-[0015], [0050], [0056], and Figs. 11A-16, e.g.).
Regarding claim 9, Hurley discloses further comprising outputting, via the at least one user device, at least one of surgical technique information; a warning during a surgical procedure being performed on the patient; or feedback to a surgeon during the surgical procedure (see paragraph [0060]; surgical technique information outputted in the form of measurement tools, implant information, and implant/bone interface fit, e.g.).
Regarding claim 10, Hurley, as modified in claim 1 above, discloses further comprising receiving the first user input and the second user input via a touchscreen of the at least one user device (see paragraphs [0047], [0059], [0060], [0079], and [0090]-[0096]).
Regarding claim 12, Hurley discloses a system comprising: one or more processors (see paragraph [0039]); and one or more memories (see paragraph [0039]) storing instructions that, when executed by the one or more processors, cause the system to perform a process (see Abstract and paragraph [0047]) comprising: displaying, via a surgery planner graphical user interface (GUI) on at least one user device, a personalized surgical plan that includes a first image of a planned corrected anatomy of a patient achieved using a first implant (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C; plate implant displayed on an anatomical image); sending, from the at least one user device, first user input for the personalized surgical plan, wherein the first user input is inputted via the surgery planner GUI (see paragraphs [0094]-[0096]; user manipulating the plate in the image); displaying, via the surgery planner GUI on the at least one user device, a modified personalized surgical plan generated by a digital implant design platform based on the first user input (see paragraphs [0094]-[0096]; user interface displays image with plate adjusted based on user input), wherein the modified personalized surgical plan includes a second image of a second implant and a modified planned corrected anatomy achieved using the second implant, wherein the second implant is different from the first implant (see paragraphs [0094]-[0096]; user interface displays modified image based on plate adjusted by user input on corrected anatomy).
Further regarding claim 12, Hurley is silent regarding wherein the digital implant design platform is configured to be trained using data obtained from a training database of the digital implant design platform. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to be trained using data obtained from a training database of the platform (see paragraphs [0055], [0056], [0100], [0173], and [0209]-[0234]). Regarding claim 14, Ryan discloses wherein the digital implant design platform is programmed to perform training for generating patient-specific surgical plans (see paragraphs [0209]-[0221]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to be trained using imaging data from a training database as suggested by Ryan in order to have the platform improve its performance though an iterative virtuous cycle by training on datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Further regarding claim 12, Hurley is silent regarding sending, from the at least one user device, second user input for the modified personalized surgical plan, wherein the second user input is inputted via the surgery planner GUI. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract), where the method includes a user sending iteratively sending user input for a modified personalized surgical plan (see Ryan, paragraphs [0056], [0057], [0083], [0084], and [0090]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have a user iteratively send user input for a modified personalized surgical plan that is inputted via the surgery planner GUI in order to allow the user to repeatedly update the surgical plan as needed to create a virtuous cycle in which the surgical plan is improved by iterative user input until a final plan is created to a user’s satisfaction (see Ryan, paragraphs [0056], [0057], [0083], [0084], and [0090]).
Regarding claim 13, Hurley discloses further comprising sending patient data to the digital implant design platform (see paragraph [0048]-[0050]), wherein the digital implant design platform has a module for designing implants (see paragraphs [0010], [0074], [0087], and [0105]). Hurley is silent regarding the platform being programmed to train the module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to train an implant design module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items (see paragraphs [0007], [0012], [0017], [0055], [0056], [0100], [0173], and [0209]-[0234]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to train an implant design module using patient data as suggested by Ryan in order to have the implant design module improve its performance though an iterative virtuous cycle by training on patient datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Further regarding claim 14, Hurley discloses wherein the surgery planner GUI includes one or more anatomical measurements (see paragraph [0060], [0078], and [0082]) and a virtual model of the patient’s anatomy (see paragraphs [0014], [0015], [0041], and [0043]). Hurley is silent on the planner including an implant recommendation, though it does provide implant options (see paragraphs [0060] and [0077]). Additionally, Hurley is silent on the virtual model being of a patient’s spine, though it does provide a virtual model of the patient’s anatomy (see paragraphs [0015], [0015], [0041], and [0043]) and states the methods are applicable to spinal surgery (see paragraph [0112]). Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that includes recommending implants (see paragraphs [0072], [0073], [0110], [0120], [0162], [0164], [0171], and [0181]) and a model of a patient’s spine (see paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the surgery planner of Hurley recommend implants to the user in order to apply machine learning training to analyze patient data and recommend an implant best for the patient based on that analysis (see Ryan, paragraphs [0072], [0073], [0110], [0120], [0162], [0164], [0171], and [0181]). Additionally, it would have been obvious to have the virtual model be of a patient’s spine, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a model of a patient’s spine as part of spinal surgery preoperative planning (see Ryan, paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]).
Regarding claim 15, Hurley discloses further comprising displaying, via the surgery planner GUI, a virtual anatomical model of a portion of a patient (see paragraphs [0008]-[0015], [0050], [0056], and Figs. 11A-16, e.g.), wherein the personalized surgical plan includes virtually positioning of the first implant and/or the second implant along the virtual anatomical model of the portion of the patient (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C; implant displayed on an anatomical image); digitally measured one or more distances (see paragraphs [0060], [0078], and [0094]); one or more user-adjustable dimensions of a virtual implant model of the first implant (see paragraphs [0060], [0078], [0082], [0086], and [0094]-[0096]); output based on the virtual implant model of the first implant implanted along the virtual anatomical model (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C); and receiving, via the surgery planner GUI, user input for interacting with a computer system programmed to design the second implant (see paragraphs [0039], [0047], [0059], [0060], [0079], and [0090]-[0096]).
Further regarding claim 15, Hurley fails to disclose the portion of the patient being a spine. However, Hurley does disclose that its method can be applied to spinal surgery (see paragraph [0112]), and Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that includes a model of a patient’s spine (see paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]). It would have been obvious to have the virtual model be of a patient’s spine, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a model of a patient’s spine as part of spinal surgery preoperative planning (see Ryan, paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]).
Further regarding claim 15, Ryan suggests digitally measuring one or more distances between vertebrae of the spine associated with a spinal deformity of the patient (see paragraphs [0066], [0154], [0158], and [0178]), and it would have been prima facie obvious to modify the method of Hurley to digitally measure distances between vertebrae in order to ensure a proper fit of a spinal implant for a specific patient (see Ryan, paragraphs [0066], [0154], [0158], and [0178]).
Further regarding claim 15, Ryan discloses output from an analysis of the anatomical model based on the implant model of the first implant implanted along the anatomical model (see paragraphs [0053], [0109], [0138], [0152], [0155], [0168]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the personalized surgical plan include output from an analysis of virtual anatomical model in order to ensure the implant is properly designed for a given patient (see Ryan, paragraphs [0053], [0109], [0138], [0152], [0155], [0168]).
Regarding claim 16, Hurley discloses wherein the computer-implemented method further comprises receiving, via the surgery planner GUI, acceptable outcome input from a user (see paragraphs [0008], [0009], [0069], [0072], [0097], and [0106]; user finalizes implant design and sends for 3D printing); and sending, from the at least one user device, the acceptable outcome input for designing the first implant for treating the patient (see paragraphs [0008], [0009], [0045], [0069], [0072], [0075], [0076], [0097], and [0106]; user sends acceptable outcome input for the finalized designed implant for 3D printing/rapid prototyping). Hurley is silent regarding the patient having a spinal deformity and the first implant being a spinal implant. However, Hurley does disclose that its method can be applied to deformity correction and spinal surgery (see paragraph [0112]), and Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that corrects a patient’s spinal deformity with a spinal implant (see paragraphs [0004], [0005], [0051], and [0072]). It would have been prima facie obvious to apply Hurley’s method to treat a spinal deformity with a spinal implant, as Hurley suggests its method is applicable to deformity correction and spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a spinal implant to correct a spinal deformity (see Ryan, paragraphs [0004], [0005], [0051], and [0072]).
Regarding claim 17, Hurley discloses further comprising providing access, via the surgery planner GUI, to viewing of a virtual anatomical model that represents anatomy of the patient (see paragraphs [0008]-[0015], [0050], [0056], and Figs. 11A-16, e.g.).
Regarding claim 18, Hurley discloses further comprising outputting, via the at least one user device, at least one of surgical technique information; a warning during a surgical procedure being performed on the patient; or feedback to a surgeon during the surgical procedure (see paragraph [0060]; surgical technique information outputted in the form of measurement tools, implant information, and implant/bone interface fit, e.g.).
Regarding claim 19, Hurley discloses a non-transitory computer-readable medium (see paragraph [0039]) storing instructions that, when executed by a computing system, cause the computing system to perform operations (see Abstract and paragraph [0047]) comprising: displaying, via a surgery planner graphical user interface (GUI) on at least one user device, a personalized surgical plan that includes a first image of a planned corrected anatomy of a patient achieved using a first implant (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C; plate implant displayed on an anatomical image); sending, from the at least one user device, first user input for the personalized surgical plan, wherein the first user input is inputted via the surgery planner GUI (see paragraphs [0094]-[0096]; user manipulating the plate in the image); displaying, via the surgery planner GUI on the at least one user device, a modified personalized surgical plan generated by a digital implant design platform based on the first user input (see paragraphs [0094]-[0096]; user interface displays image with plate adjusted based on user input), wherein the modified personalized surgical plan includes a second image of a second implant and a modified planned corrected anatomy achieved using the second implant, wherein the second implant is different from the first implant (see paragraphs [0094]-[0096]; user interface displays modified image based on plate adjusted by user input on corrected anatomy).
Further regarding claim 19, Hurley is silent regarding wherein the digital implant design platform is configured to be trained using data obtained from a training database of the digital implant design platform. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to be trained using data obtained from a training database of the platform (see paragraphs [0055], [0056], [0100], [0173], and [0209]-[0234]). Regarding claim 21, Ryan discloses wherein the digital implant design platform is programmed to perform training for generating patient-specific surgical plans (see paragraphs [0209]-[0221]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to be trained using imaging data from a training database as suggested by Ryan in order to have the platform improve its performance though an iterative virtuous cycle by training on datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Further regarding claim 19, Hurley is silent regarding sending, from the at least one user device, second user input for the modified personalized surgical plan, wherein the second user input is inputted via the surgery planner GUI. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract), where the method includes a user sending iteratively sending user input for a modified personalized surgical plan (see Ryan, paragraphs [0056], [0057], [0083], [0084], and [0090]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have a user iteratively send user input for a modified personalized surgical plan that is inputted via the surgery planner GUI in order to allow the user to repeatedly update the surgical plan as needed to create a virtuous cycle in which the surgical plan is improved by iterative user input until a final plan is created to a user’s satisfaction (see Ryan, paragraphs [0056], [0057], [0083], [0084], and [0090]).
Regarding claim 20, Hurley discloses further comprising sending patient data to the digital implant design platform (see paragraph [0048]-[0050]), wherein the digital implant design platform has a module for designing implants (see paragraphs [0010], [0074], [0087], and [0105]). Hurley is silent regarding the platform being programmed to train the module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to train an implant design module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items (see paragraphs [0007], [0012], [0017], [0055], [0056], [0100], [0173], and [0209]-[0234]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to train an implant design module using patient data as suggested by Ryan in order to have the implant design module improve its performance though an iterative virtuous cycle by training on patient datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Further regarding claim 21, Hurley discloses wherein the surgery planner GUI includes one or more anatomical measurements (see paragraph [0060], [0078], and [0082]) and a virtual model of the patient’s anatomy (see paragraphs [0014], [0015], [0041], and [0043]). Hurley is silent on the planner including an implant recommendation, though it does provide implant options (see paragraphs [0060] and [0077]). Additionally, Hurley is silent on the virtual model being of a patient’s spine, though it does provide a virtual model of the patient’s anatomy (see paragraphs [0015], [0015], [0041], and [0043]) and states the methods are applicable to spinal surgery (see paragraph [0112]). Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that includes recommending implants (see paragraphs [0072], [0073], [0110], [0120], [0162], [0164], [0171], and [0181]) and a model of a patient’s spine (see paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to have the surgery planner of Hurley recommend implants to the user in order to apply machine learning training to analyze patient data and recommend an implant best for the patient based on that analysis (see Ryan, paragraphs [0072], [0073], [0110], [0120], [0162], [0164], [0171], and [0181]). Additionally, it would have been obvious to have the virtual model be of a patient’s spine, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a model of a patient’s spine as part of spinal surgery preoperative planning (see Ryan, paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]).
Regarding claim 22, Hurley discloses further comprising displaying, via the surgery planner GUI, a virtual anatomical model of a portion of a patient (see paragraphs [0008]-[0015], [0050], [0056], and Figs. 11A-16, e.g.), wherein the personalized surgical plan includes virtually positioning of the first implant and/or the second implant along the virtual anatomical model of the portion of the patient (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C; implant displayed on an anatomical image); digitally measured one or more distances (see paragraphs [0060], [0078], and [0094]); one or more user-adjustable dimensions of a virtual implant model of the first implant (see paragraphs [0060], [0078], [0082], [0086], and [0094]-[0096]); output based on the virtual implant model of the first implant implanted along the virtual anatomical model (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C); and receiving, via the surgery planner GUI, user input for interacting with a computer system programmed to design the second implant (see paragraphs [0039], [0047], [0059], [0060], [0079], and [0090]-[0096]).
Further regarding claim 22, Hurley fails to disclose the portion of the patient being a spine. However, Hurley does disclose that its method can be applied to spinal surgery (see paragraph [0112]), and Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that includes a model of a patient’s spine (see paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]). It would have been obvious to have the virtual model be of a patient’s spine, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a model of a patient’s spine as part of spinal surgery preoperative planning (see Ryan, paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]).
Further regarding claim 22, Ryan suggests digitally measuring one or more distances between vertebrae of the spine associated with a spinal deformity of the patient (see paragraphs [0066], [0154], [0158], and [0178]), and it would have been prima facie obvious to modify the method of Hurley to digitally measure distances between vertebrae in order to ensure a proper fit of a spinal implant for a specific patient (see Ryan, paragraphs [0066], [0154], [0158], and [0178]).
Further regarding claim 22, Ryan discloses output from an analysis of the anatomical model based on the implant model of the first implant implanted along the anatomical model (see paragraphs [0053], [0109], [0138], [0152], [0155], [0168]), and it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the personalized surgical plan include output from an analysis of virtual anatomical model in order to ensure the implant is properly designed for a given patient (see Ryan, paragraphs [0053], [0109], [0138], [0152], [0155], [0168]).
Regarding claim 23, Hurley discloses wherein the computer-implemented method further comprises receiving, via the surgery planner GUI, acceptable outcome input from a user (see paragraphs [0008], [0009], [0069], [0072], [0097], and [0106]; user finalizes implant design and sends for 3D printing); and sending, from the at least one user device, the acceptable outcome input for designing the first implant for treating the patient (see paragraphs [0008], [0009], [0045], [0069], [0072], [0075], [0076], [0097], and [0106]; user sends acceptable outcome input for the finalized designed implant for 3D printing/rapid prototyping). Hurley is silent regarding the patient having a spinal deformity and the first implant being a spinal implant. However, Hurley does disclose that its method can be applied to deformity correction and spinal surgery (see paragraph [0112]), and Ryan discloses a method for developing patient-specific spinal implants (see Abstract) that corrects a patient’s spinal deformity with a spinal implant (see paragraphs [0004], [0005], [0051], and [0072]). It would have been prima facie obvious to apply Hurley’s method to treat a spinal deformity with a spinal implant, as Hurley suggests its method is applicable to deformity correction and spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a spinal implant to correct a spinal deformity (see Ryan, paragraphs [0004], [0005], [0051], and [0072]).
Claims 24-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hurley in view of Ryan and U.S. Patent Application Publication No. 2012/0230573 (Ito).
Regarding claim 24, Hurley discloses a method (see Abstract) comprising: sending image data of a patient and surgery information for the patient to a digital implant design platform (see paragraphs [0049] and [0050]), wherein the digital implant design platform is configured to generate a surgical plan based on the image data and the surgery information (see paragraphs [0049]-[0053], [0059], [0075]-[0077], and [0084]); displaying, via a surgery planner graphical user interface (GUI) on at least one user device (see paragraphs [0046]-[0048]; tablet user device, e.g.), the surgical plan a viewable first treatment including a first image of a first implant positioned along a planned first anatomy of the patient achieved using the first implant (see paragraphs [0046], [0047], [0077], [0088], and [0094] and Figs. 13C; image of a plate implant displayed on an anatomy of the patient), and a viewable second treatment including a second image of a second implant positioned along a planned second anatomy of the patient achieved using the second implant, wherein the second implant is different from the first implant (see paragraphs [0094]-[0096]; user interface displays modified, second image based on a plate implant after adjustment by user input on planned second anatomy); and sending, from the at least one user device, treatment input for the surgical plan (see paragraphs [0094]-[0096]; user manipulating the plate implant).
Further regarding claim 25, Hurley is silent regarding the surgery information being spinal surgery information. However, Hurley does disclose that its method can be applied to spinal surgery (see paragraph [0112]), and Ryan discloses a method for developing patient-specific spinal implants (see Abstract) for spinal surgery (see paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]). It would have been obvious to have the surgery information be spinal surgery information, as Hurley suggests its method is applicable to spinal surgery procedures (see Hurley, paragraph [0112]) and Ryan suggests using a model of a patient’s spine and spinal implant formation as part of spinal surgery preoperative planning (see Ryan, paragraphs [0007], [0012], [0017], [0202], [0226], and [0230]).
Further regarding claim 24, Hurley is silent regarding the design platform being configured to be trained using data obtained from a training database of the digital implant design platform. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to be trained using data obtained from a training database of the platform (see paragraphs [0055], [0056], [0100], [0173], and [0209]-[0234]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to be trained using data from a training database as suggested by Ryan in order to have the platform improve its performance though an iterative virtuous cycle by training on datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Further regarding claim 24 and regarding claim 26, Hurley is silent regarding simultaneously displaying, via the surgery planner GUI, (1) the first image and first spinal metrics for the planned first anatomy and (2) the second image and second spinal metrics for the planned second anatomy. However, Ryan suggests using spinal metrics of spinal anatomy as part of designing spinal implants for the preoperative surgical plan (see paragraphs [0066], [0154], [0158], and [0178]), and Ito discloses a preoperative surgical planning method (see Abstract) that includes simultaneously displaying an image with anatomical metrics (see paragraphs [0125] and [0126] and Figs. 18A-19B). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to simultaneous display images with metric information as suggested by Ito in order to allow a user to see anatomical data relevant to a user’s evaluation of a proposed treatment using a virtual model (anatomical data relevant to the sizing and shaping of a patient specific implant being used in the virtual model, e.g.).
Regarding claims 25 and 27, Ryan suggests wherein the spinal surgery information includes implant information for designing the first implant and the second implant (see paragraphs [0066] and [0153]-[0165]; cage height information for designing a spinal cage implant, e.g.) (claim 25); and wherein the second spinal metrics include one or more distances obtained by digitally measuring the one or more distances between vertebrae of the patient's spine associated with a spinal deformity of the patient (see paragraphs [0066] and [0153]-[0165]; disc height information between two adjacent vertebrae) (claim 27). It would have been obvious to modify the method to use implant information and vertebral distance in order to provide a patient-specific implant optimal for a patient by using a patient’s disc height to provide an implant sized to appropriately fit within a patient’s disc space.
Regarding claim 28, Hurley discloses wherein the digital implant design platform has a module for designing implants (see paragraphs [0010], [0074], [0087], and [0105]). Hurley is silent regarding the platform being programmed to train the module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items. However, Ryan discloses a method for developing patient-specific spinal implants (see Abstract) wherein a digital implant design platform is configured to train an implant design module by inputting the patient data into the module programmed to select data of the patient data as training items and to generate output based on the training items (see paragraphs [0007], [0012], [0017], [0055], [0056], [0100], [0173], and [0209]-[0234]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Hurley to have the design platform configured to train an implant design module using patient data as suggested by Ryan in order to have the implant design module improve its performance though an iterative virtuous cycle by training on patient datasets that increase in size over time (see Ryan, paragraph [0056], e.g.).
Conclusion
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
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