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 1-4, 6-12, 14-19, 21, and 22 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. 2018/0303352 (Ryan).
Regarding claim 1, Hurley discloses a computer-implemented method for designing a patient-specific spinal implant (see paragraphs [0074], [0116], [0117]), comprising: generating a virtual digital model of a spine of a first patient representing a first planned outcome for a patient (see paragraphs [0005], [0009], [0040]-[0045], [0112]); storing the virtual digital model of the spine in a database of an implant design computer system (see paragraphs [0056], [0086], [0087]); designing, using the implant design computer system, a patient-specific implant to achieve the first planned outcome, wherein the patient-specific implant is designed based on a virtual digital implant model of the patient-specific implant positioned along the virtual digital model of the spine (see paragraphs [0084]-[0098]); and after the patient-specific implant is implanted in the first patient, receiving a set of post-operative images of the first patient (see paragraph [0111]); and designing, via the implant design computer system, at least one patient- specific implant for a second patient using a virtual digital model of the second patient representing a second planned outcome for the second patient (see paragraphs [0005],[0009], [0040]-[0045], [0084-[0098]; preoperative plans and implants can be created for multiple patients).
Hurley fails to disclose training the implant design computer system using at least one of the post-operative images of the first patient. However, Ryan discloses a method for developing patient-specific spinal treatments that includes training a model using post-operative images of a first patient (see paragraphs [0052], [0053], [0074], [0100]-[0108], and Fig. 4). 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 train the implant design computer system using the pre-operative images of the patient in order to provide a virtuous cycle of improvement via machine learning wherein the system will use post-operative data from previous patients to help develop better custom implant treatments for future patients (see Ryan, paragraphs [0052], [0053], [0074], [0100]-[0108], and Fig. 4).
Regarding claim 9, Hurley discloses a computing system (see Abstract and paragraph [0039]) comprising: one or more processors (see paragraph [0039]); and one or more memories storing instructions that, when executed by the one or more processors, cause the computing system to perform a process (see paragraph [0039]) comprising: generating a virtual digital model of a spine of a first patient representing a first planned outcome for a patient (see paragraphs [0005], [0009], [0040]-[0045], [0112]); storing the virtual digital model of the spine in a database of an implant design computer system (see paragraphs [0056], [0086], [0087]); designing, using the implant design computer system, a patient-specific implant to achieve the first planned outcome, wherein the patient-specific implant is designed based on a virtual digital implant model of the patient-specific implant positioned along the virtual digital model of the spine (see paragraphs [0084]-[0098]); and after the patient-specific implant is implanted in the first patient, receiving a set of post-operative images of the first patient (see paragraph [0111]); and designing, via the implant design computer system, at least one patient-specific implant for a second patient using a virtual digital model of the second patient representing a second planned outcome for the second patient (see paragraphs [0005],[0009], [0040]-[0045], [0084-[0098]; preoperative plans and implants can be created for multiple patients).
Hurley fails to disclose training the implant design computer system using at least one of the post-operative images of the first patient. However, Ryan discloses a method for developing patient-specific spinal treatments that includes training a model using post-operative images of a first patient (see paragraphs [0052], [0053], [0074], [0100]-[0108], and Fig. 4). 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 train the implant design computer system using the pre-operative images of the patient in order to provide a virtuous cycle of improvement via machine learning wherein the system will use post-operative data from previous patients to help develop better custom implant treatments for future patients (see Ryan, paragraphs [0052], [0053], [0074], [0100]-[0108], and Fig. 4).
Regarding claim 16, Hurley discloses a non-transitory computer-readable storage medium (see paragraph [0039]) storing instructions that, when executed by a computing system, cause the computing system to perform a process comprising: generating a virtual digital model of a spine of a first patient representing a first planned outcome for a patient (see paragraphs [0005], [0009], [0040]-[0045], [0112]); storing the virtual digital model of the spine in a database of an implant design computer system (see paragraphs [0056], [0086], [0087]); designing, using the implant design computer system, a patient-specific implant to achieve the first planned outcome, wherein the patient-specific implant is designed based on a virtual digital implant model of the patient-specific implant positioned along the virtual digital model of the spine (see paragraphs [0084]-[0098]); and after the patient-specific implant is implanted in the first patient, receiving a set of post-operative images of the first patient (see paragraph [0111]); and designing, via the implant design computer system, at least one patient-specific implant for a second patient using a virtual digital model of the second patient representing a second planned outcome for the second patient (see paragraphs [0005],[0009], [0040]-[0045], [0084-[0098]; preoperative plans and implants can be created for multiple patients).
Hurley fails to disclose training the implant design computer system using at least one of the post-operative images of the first patient. However, Ryan discloses a method for developing patient-specific spinal treatments that includes training a model using post-operative images of a first patient (see paragraphs [0052], [0053], [0074], [0100]-[0108], and Fig. 4). 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 train the implant design computer system using the pre-operative images of the patient in order to provide a virtuous cycle of improvement via machine learning wherein the system will use post-operative data from previous patients to help develop better custom implant treatments for future patients (see Ryan, paragraphs [0052], [0053], [0074], [0100]-[0108], and Fig. 4).
Regarding claims 2, 10, and 17, Hurley discloses wherein the virtual digital model of the first patient is a three-dimensional model (see paragraphs [0040]-[0045], e.g.); and receiving, via a displayed graphical user interface, user input for modifying the design of the patient-specific implant (see paragraphs [0014], [0015], and [0078]-[0084]). Hurley fails to disclose wherein the patient-specific implant is a cage, though does disclose that its method and system may be applied to spinal surgery (see paragraph [0112]). Additionally, Ryan discloses wherein a patient-specific implant is a cage (see paragraph [0112], e.g.), and wherein designing the patient-specific implant includes: digitally measuring one or more distances between features of vertebrae of the first patient associated with a spinal deformity (see paragraphs [0120]-[0165]); adjusting one or more dimensions of a virtual implant model of the patient-specific implant based on the one or more distances, at least one design algorithm stored by the database, and at least one implant design constraint stored by the database (see paragraphs [0120]-[0165]); analyzing the virtual digital model of the spine based on the adjusted virtual implant model of the patient-specific implant positioned along the virtual digital model of the spine (see paragraphs [0120]-[0165]); and receiving, via a displayed graphical user interface, user input for modifying the design of the patient-specific implant (see paragraphs [0066], [0173], and [0252], e.g.). 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 utilize the method/process of designing a patient-specific spinal cage in Ryan in the method/process of Hurley, as Hurley suggests its methods may be used in spinal surgery applications (see paragraph [0112], and Ryan suggests that measuring, adjusting, and analyzing steps in addition to receiving user input are useful in optimizing the cage design for a given patient (see Ryan, paragraphs [0066], [0120]-[0165], and [0173]).
Regarding claims 3, 11, and 18, Hurley fails to disclose wherein the patient has a spinal deformity, though does disclose that its method and system may be applied to spinal surgery (see paragraph [0112]). Additionally, Ryan discloses wherein the patient has a spinal deformity (see paragraph [0051]), and designing of the patient-specific implant is based on an acceptable treatment outcome for the spinal deformity using the patient-specific implant (see paragraphs [0120-[0165]). 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 apply the method/process of Hurley to treat a spinal deformity via a patient-specific cage as Hurley suggests its methods may be used in spinal surgery applications (see paragraph [0112], and Ryan suggests designing a patient-specific cage be based on an acceptable treatment outcome for the spinal deformity using the patient-specific cage (see paragraphs [0120-[0165]; patient-specific spinal cage restores proper spinal curvature).
Regarding claims 4, 12, and 19, Hurley discloses further comprising identifying first salient features of the patient's anatomy and second salient features of the patient's anatomy (see paragraph [0051] and [0059], e.g.), but is silent regarding using the implant design computer system to identify these features; determining a first anatomical measurement between the first salient features of using a first measurement algorithm applied to the virtual digital model of the spine, wherein the first measurement algorithm is stored by the database; and determining a second anatomical measurement between second salient features using a second measurement algorithm applied to the virtual digital model of the spine, wherein the second measurement algorithm is stored by the database, and wherein the implant design computer system is programmed to design the patient-specific implant based on the first and second anatomical measurements. However, Ryan discloses using the implant design computer system to identify first and second salient features of a patient’s anatomy (see paragraph [0120]-[0165]; ligaments or endplates, e.g.); determining a first anatomical measurement between the first salient features of using a first measurement algorithm applied to the virtual digital model of the spine, wherein the first measurement algorithm is stored by the database (see paragraphs [0120]-[0165]); and determining a second anatomical measurement between second salient features using a second measurement algorithm applied to the virtual digital model of the spine, wherein the second measurement algorithm is stored by the database (see paragraphs [0120]-[0165], and wherein the implant design computer system is programmed to design the patient-specific implant based on the first and second anatomical measurements (see paragraphs[ 0120]-[0165]; cage dimensions and shape are based on anatomical measurements of ligament lengths and endplate distances/disc heights, e.g.). 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 apply the method/process of Hurley to treat a spinal deformity via a patient-specific cage as Hurley suggests its methods may be used in spinal surgery applications (see paragraph [0112], and Ryan suggests designing a patient-specific cage be based on measurements of salient anatomical features (see paragraphs [0120-[0165]; patient-specific spinal cage dimensions and shape based on ligament and disc space measurements, e.g.).
Regarding claims 6, 14, and 21, Hurley discloses wherein the implant design computer system is programmed to perform a physician guided implant design process (see paragraphs [0074], [0078]-[0084], [0090], and [0114-0117]), wherein a design module is programmed to: provide patient information for viewing by a user to assist with design of the patient-specific implant (see paragraphs [0005], [0009], [0040]-[0045] and Figs. 2A-5, e.g.), wherein the patient information includes one or more patient images and/or implant position data (see paragraphs [0005], [0009], [0040]-[0045], [0078]-[0084], [0090], and [0114-0117], and Figs. 2A-5, e.g.), receive input from a user (see paragraphs [0014], [0015], and [0078]-[0084]), and modify, based on the input from the user, at least one of a design of the patient-specific implant or a treatment for the patient (see paragraphs [0014], [0015], and [0078]-[0084]). Hurley is silent regarding wherein the implant design computer system includes a spine network base module programmed to provide implant design information for the physician guided implant design process; an abnormalities module programmed to measure distances between salient features of anatomical structures of the patient; and a design module configured to receive implant design information from spine network base module and measurement information from the abnormalities module. However, Ryan discloses an implant design computer system including a spine network base module programmed to provide implant design information for an implant design process (see paragraphs [0120]-[0165]); an abnormalities module programmed to measure distances between salient features of anatomical structures of the patient (see paragraphs [0120]-[0165]); and a design module configured to receive implant design information from spine network base module and measurement information from the abnormalities module (see paragraphs [0120]-[0165]). It would have been prima facie obvious to person of ordinary skill in the art before the effective filing date of the invention to utilize the method/process of designing a patient-specific spinal implant in Ryan in the method/process of Hurley, as Hurley suggests its methods may be used in spinal surgery applications (see paragraph [0112], and Ryan suggests that a base module, abnormalities module, and design module are useful in optimizing the cage design for a given patient (see Ryan, paragraphs [0066], [0120]-[0165], and [0173]).
Regarding claims 7, 15, and 22, Hurley is silent regarding further comprising: iteratively simulating surgical outcomes based on the virtual digital model of the patient's spine to generate predicted outcomes for the patient; and determining whether each of the predicted outcomes is acceptable, wherein the acceptable outcome is one of the predicted outcomes determined to be acceptable for designing the patient-specific implant. However, Ryan discloses a method of designing a patient specific implant that includes iteratively simulating surgical outcomes based on a virtual digital model of the patient's spine to generate predicted outcomes for the patient (see Abstract and paragraphs [0052], [0056], [0116]-[0125], and [0165]); and determining whether each of the predicted outcomes is acceptable, wherein the acceptable outcome is one of the predicted outcomes determined to be acceptable for designing the patient-specific implant (see Abstract and paragraphs [0052], [0056], [0116]-[0125], and [0165]). 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/process of Hurley to include the method of designing a patient-specific implant suggested by Ryan as Ryan suggests iteratively simulating surgical outcomes and determining whether the predicted outcomes are acceptable is part of a virtuous cycle to help determine an optimal patient-specific implant for a given patient (see Ryan, Abstract and paragraphs [0052], [0056], [0116]-[0125], and [0165]).
Regarding claim 8, Hurley is silent regarding further comprising: determining one or more values for the patient's spine based on the virtual digital model of the patient's spine, wherein the one or more values indicate a configuration for the patient's spine; and determining one or more dimensions for the patient-specific implant based on the determined one or more values. However, Ryan discloses a method for designing a patient-specific spinal implant that comprises determining one or more values for the patient's spine based on the virtual digital model of the patient's spine, wherein the one or more values indicate a configuration for the patient's spine (see paragraphs [0120]-[0165]; ligament and disc space values, e.g.); and determining one or more dimensions for the patient-specific implant based on the determined one or more values (see paragraphs [0120]-[0165]; implant sized and shaped based on ligament and disc space measurements, e.g.). It would have been prima facie obvious to person of ordinary skill in the art before the effective filing date of the invention to utilize the method/process of designing a patient-specific spinal implant in Ryan in the method/process of Hurley, as Hurley suggests its methods may be used in spinal surgery applications (see paragraph [0112], and Ryan suggests that determining patient spine values are useful for determining dimensions of a patient-specific spinal implant in order to ensure the implant is properly sized for a given patient (see Ryan, paragraphs [0066], [0120]-[0165], and [0173]).
Claims 5, 13, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hurley in view of Ryan, and further in view of U.S. Patent Application Publication No. 2008/0262624 (White).
Regarding claims 5, 13, and 20, Hurley and White fail to explicitly disclose wherein the first planned outcome is based on a surgeon accepted model generated by the implant design computer system. However, White discloses a method for making a patient-modified orthopedic implant (see Abstract), wherein planned outcome is based on a surgeon accepted model generated by an implant design computer system (see paragraph [0028]). 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/process of Hurley in view of Ryan to have the first planned outcome be based on a surgeon accepted model generated by an implant design computer system as suggested by White in order to ensure a patient-specific implant designed and analyzed by the system is proper for a patient (see White, paragraph [0028]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Amanatullah discloses using virtual anatomical models to facilitate surgery.
Laster discloses methods and systems for using a model to determine implants needed for a surgical procedure.
Park discloses using an image-based model for designing a patient-specific spinal surgery implant and method.
McGuan discloses a method and system for simulating using an implant in a patient.
Belcher discloses a method for preparing a surgical plan based on a 3-D image of patient and selecting an orthopedic implant based on the plan.
Mire discloses a method and system to plan a surgical procedure that includes forming a model of an anatomy of a patient and selecting a prosthetic for the procedure.
Richard discloses a method for modeling an anatomical structure of a patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS J PLIONIS whose telephone number is (571)270-3027. The examiner can normally be reached on Monday - Friday, 9:00 a.m. - 5:00 p.m. EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eduardo Robert, can be reached on 571-272-4719. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773
Prosecution Insights