DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This Final Office Action is in response to the Amendment and Remarks filed 10/22/2025. Claims 1, 9 and 13 are amended. Claims 17-22 are new. Claims 1-22 are pending and considered herein.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1-4, 6-17 and 20 are rejected under 35 U.S.C. 103(a) as unpatentable over U.S. 2010/0191071 A1 to Anderson et al., hereinafter “Anderson,” in view of U.S. 11,112,770 B2 to Roh et al., hereinafter “Roh” and further in view of U.S. 9,411,939 B2 to Furrer et al., hereinafter “Furrer.”
Regarding claim 1, Anderson discloses A computer-implemented method for designing a patient-specific implant, the computer-implemented method comprising: generating a pre-operative virtual three-dimensional anatomical model representing pre-operative spinal anatomy of a patient (See Anderson at least at Abstract; Paras. [0059], [0068] (“[S]oftware is used to generate a three-dimensional model of the patient's spine, the TruBalance software is used to calculate a global balance for the patient, and the DRPro software is used to measure the images.”), [0093]-[0096], [0121]-[0122]; Figs. 6, 13-18); and generating a planned post-operative virtual three-dimensional anatomical model representing a corrected spinal pathology for the patient, wherein the planned post-operative virtual three-dimensional anatomical model is based on: the pre-operative virtual three-dimensional anatomical model, and at least in part on the one or more reference patient data sets (See id. at least at Paras. [0059], [0068], [0074], [0087]-[0088] (“[M]odeling of the treatment options at step 30 can be updated to correspond with the outcomes as observed in the post-treatment analysis of step 38.”), [0093]-[0096] (““Modeling of the treatment options builds upon the animated model of the patient used during the patient diagnosis and analysis. Thus, in many aspects the module 14 utilizes the same features described above in modeling the treatment options. However, in modeling the treatment options the modeling module 14 modifies the model by replacing a damaged portion of the patient's anatomy with an implant. The module 14 then utilizes the characteristics of the implant in modeling the patient's anatomical motion sequences.”), [0100]; Figs. 2, 13-18).
Anderson may not specifically describe but Roh teaches identifying, using at least one trained machine-learning model, one or more reference patient data sets (See Roh at least at Col. 4, ln. 4-17; Col. 5, ln. 3-33; Col. 9, ln. 9 – Col. 10, ln. 9; Figs. 9-13); designing, using the planned post-operative virtual three-dimensional anatomical model, a patient-specific implant configured to be implanted in the patient to achieve the planned corrected spinal pathology (See Roh at least at Col. 4, ln. 4-47 (“The implants (e.g., screws, screw holders, rods, etc.) can be designed and manufactured for the patient and the instruments can be standard instruments. This allows the components that are implanted to be designed and manufactured based on the patient's anatomy, and/or surgeon's preferences to enhance treatment. The patient-specific devices can improve, without limitation, delivery into the patient's body, placement at the treatment site, and interaction with the patient's anatomy. For example, embodiments of the system can be used to produce pedicle screws and components to avoid the problems discussed in connection with FIGS. 1A and 1B, as well as other problems.”); Col. 5, ln. 64 – Col. 6, ln. 30; Col. 7, ln. 39 – Col. 8, ln. 54; Claim 1; Figs. 1-4, 9-13); generating fabrication data for at least a portion of the patient-specific implant (See id. at least at Col. 6, ln. 31 – Col. 8, ln. 44 (“A patient-specific implant can be manufactured based, at least in part, on the implant configuration selected for the patient. Each patient can receive an implant that is specifically designed for their anatomy. In some procedures, the system 452 can handle the entire design and manufacturing process. In other embodiments, a physician can alter the implant configuration for further customization. An iterative design process can be employed in which the physician and system 452 work together. For example, the system 452 can generate a proposed patient-specific implant. The physician can identify characteristics of the implant to be changed and can input potential design changes. The system 452 can analyze the feedback from the physician to determine a refined patient-specific implant design and to produce a patient-specific model. This process can be repeated any number of times until arriving at a suitable design. Once approved, the implant can be manufactured based on the selected design.”); Col. 15, ln. 16-23; Claims 2, 10; Figs. 1-4, 9-13).
Anderson further discloses causing a user interface to display (See Anderson at least at Paras. [0082], [0095], [0102]; Figs. 1-2, 4, 10-12, 16). The references may not specifically describe but Furrer teaches a virtual model from two or more perspectives showing a virtual three-dimensional implant model of the patient-specific implant positioned along the planned post-operative virtual three- dimensional anatomical model; and manufacturing at least a portion of the patient-specific implant (See Furrer at least at Col. 1, ln. 47 – Col. 2, ln. 11; Col. 6, ln. 41 – Col. 8, ln. 19 (“A virtual three-dimensional model of an orthopedic implant, such as the orthopedic implant 100, can be obtained. The virtual three-dimensional model of the orthopedic implant 100 can be composed of data that can be manipulated by a processor and that can be read by a non-transitory computer-readable medium. This data can be in different formats. For example, the virtual three-dimensional model of the orthopedic implant 100 can include data in a Standard Tessellation Language (STL) format. Irrespective of the data format, the virtual three-dimensional model of the orthopedic implant 100 includes data that maps the shape, contour, and size of the orthopedic implant 100. The virtual three-dimensional model of the orthopedic implant 100 can be created virtually in a computer. In the computing device 402 or another computing device, the virtual three-dimensional model of the orthopedic implant 100 is designed so that is contoured and shaped to fit over a particular portion of the virtual three-dimensional model of the tissue body […] Once the virtual three-dimensional model of the orthopedic implant 100 has been completed, the orthopedic implant 100 can be created using any suitable technology. The completed virtual three-dimensional model of the orthopedic implant 100 can be downloaded or transferred from the computing device 402 to a manufacturing machine 404 such as a CAD/CAM manufacturing machine. The completed virtual three-dimensional model of the orthopedic implant 100 can be transferred or downloaded directly from the computing device 402 to the manufacturing machine); Claim 6; Figs. 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson to incorporate the teachings of Roh and Furrer and provide a fabrication and design data for a patient implant and manufacturing. Roh is directed to producing patient-specific medical devices and implants. Furrer relates to a method of making a patient specific surgical orthopedic implant includes obtaining a virtual model of the orthopedic implant. Incorporating the patient-specific design and manufacture of spinal implants as in Roh with the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claim 2, Anderson as modified by Roh and Furrer and Furrer discloses all the limitations of claim 1 and Roh further teaches wherein generating the planned post-operative virtual three-dimensional anatomical model includes repositioning one or more virtual spinal elements of the pre-operative virtual three-dimensional anatomical model for changing spinal alignment (See Roh at least at Col. 10, ln. 26-64; Col. 18, ln. 41-50; Figs. 8, 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson and Furrer to incorporate the teachings of Roh and provide an adjusted design data for a patient implant. Roh is directed to producing patient-specific medical devices and implants. Incorporating the patient-specific design and manufacture of spinal implants as in Roh with the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claim 3, Anderson as modified by Roh and Furrer discloses all the limitations of claim 1 and Roh further teaches wherein the planned post-operative virtual three-dimensional anatomical model is configured to be measured to determine predicted planned outcome metrics for the patient (See id. at least at Col. 22, ln. 29-43; Col. 5, ln. 3-44; Col. 9, ln. 46-67; Col. 16, ln. 55 – Col. 17, ln. 13; Claim 5; Figs. 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson and Furrer to incorporate the teachings of Roh and provide a measuring data and planned outcome metrics for a patient surgery and implant. Roh is directed to producing patient-specific medical devices and implants. Incorporating the patient-specific design and manufacture of spinal implants as in Roh with the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claim 4, Anderson as modified by Roh and Furrer discloses all the limitations of claim 1 and Roh further teaches wherein the pre-operative virtual three-dimensional anatomical model has virtual anatomical features capable of being virtually repositioned based on user input and output from the at least one trained machine- learning model (See id. at least at Col. 9, ln. 46-67; Col. 16, ln. 44 – Col. 19, ln. 6; Col. 22, ln. 29-43; Claims 1, 5; Figs. 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson and Furrer to incorporate the teachings of Roh and provide repositioning and adjusting an implant model for a patient. Roh is directed to producing patient-specific medical devices and implants. Incorporating the patient-specific design and manufacture of spinal implants as in Roh with the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claim 6, Anderson as modified by Roh and Furrer discloses all the limitations of claim 1 and Roh further teaches scoring a group of reference patient data sets; and identifying the one or more reference patient data sets from the group based on the scoring (See id. at least at Col. 9, ln. 9-24; Col. 18, ln. 62 – Col. 19, ln. 7; Col. 23, ln. 26 – Col. 24, ln. 28; Claim 5; Figs. 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson and Furrer to incorporate the teachings of Roh and provide identification of patient data based on scoring. Roh is directed to producing patient-specific medical devices and implants. Incorporating the patient-specific design and manufacture of spinal implants as in Roh with the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claim 7, Anderson as modified by Roh and Furrer discloses all the limitations of claim 6 and Roh further teaches wherein the one or more reference patient data sets each has a score that represents a statistical correlation to data of the patient (See id. at least at Col. 9, ln. 9-24; Col. 18, ln. 62 – Col. 19, ln. 7; Col. 23, ln. 26 – Col. 24, ln. 28 (“In some implementations, model training data input can include surgeon specifics, such as statistics or preferences for implant configurations used by the surgeon performing the implant surgery or outcomes for implant usages.”); Claim 5; Figs. 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson and Furrer to incorporate the teachings of Roh and provide identification of pertinent or preferred patient data. Roh is directed to producing patient-specific medical devices and implants. Incorporating the patient-specific design and manufacture of spinal implants as in Roh with the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claim 8, Anderson as modified by Roh and Furrer discloses all the limitations of claim 1 and Roh further teaches using the at least one trained machine-learning model to: select a subset of the one or more reference patient data sets based on simulated treatment outcomes, wherein each reference patient data set of the selected subset includes a favorable scored treatment outcome, wherein designing the patient-specific implant is based on the selected subset of the one or more model patient data sets (See id. at least at Col. 9, ln. 9-24; Col. 18, ln. 62 – Col. 19, ln. 7; Col. 23, ln. 26 – Col. 24, ln. 28 (“In some implementations, model training data input can include surgeon specifics, such as statistics or preferences for implant configurations used by the surgeon performing the implant surgery or outcomes for implant usages.”); Claim 5; Figs. 11-13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson to incorporate the teachings of Roh and provide identification of pertinent or preferred patient data. Roh is directed to producing patient-specific medical devices and implants. Incorporating the patient-specific design and manufacture of spinal implants as in Roh with the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claims 9, 13, 17 and 20, claims 9, 13, 17 and 20 recite substantially the same limitations as recited in independent claim 1 and are rejected under the same grounds of rejection and reasoning as applied to claim 1, above.
Regarding claims 10 and 14, claims 10 and 14 recite substantially the same limitations as recited in claim 2 and are rejected under the same grounds of rejection and reasoning as applied to claim 2, above.
Regarding claims 11 and 15, claims 10 and 14 recite substantially the same limitations as recited in claim 3 and are rejected under the same grounds of rejection and reasoning as applied to claim 3, above.
Regarding claims 12 and 16, claims 12 and 16 recite substantially the same limitations as recited in claim 4 and are rejected under the same grounds of rejection and reasoning as applied to claim 4, above.
Claim 5 is rejected under 35 U.S.C. 102(3) as unpatentable over Anderson, in view of Roh, in view of Furrer and further in view of U.S. 2018/0303552 A1 to Ryan et al., hereinafter “Ryan.”
Regarding claim 5, Anderson as modified by Roh and Furrer discloses all the limitations of claim 1. The references may not specifically describe but Ryan teaches wherein each of the one or more reference patient data sets includes data representing one or more of lumbar lordosis, Cobb angle, pelvic incidence, disc height, segment flexibility, bone quality, rotational displacement, or treatment level of the patient's spine (See Ryan at least at Paras. [0007], [0012], [0014], [0160]-[0161], [0220]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson, Roh and Furrer to incorporate the teachings of Ryan and provide various spinal metrics. Ryan is directed to systems for developing spinal treatments and operations for patients. Incorporating the spinal treatments and techniques as in Ryan with the patient-specific design and manufacture of spinal implants as in Roh, the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Claims 18-19 and 21-22 are rejected under 35 U.S.C. 102(3) as unpatentable over Anderson, in view of Roh, in view of Furrer and further in view of U.S. 2015/0127316 A1 to Avisar, hereinafter “Avisar.”
Regarding claim 18, Anderson as modified by Roh and Furrer discloses all the limitations of claim 17. The references may not specifically describe but Avisar teaches generating a surgical plan for a surgical robot system to implant the patient-specific implant in the patient to achieve the corrected spinal pathology for the patient (See Avisar at least at Paras. [0032]-[0038] (“the system/method can be utilized by medical imagery navigation systems and image guided and robotic surgery systems that can enhance their planning performances by utilization of Surgical Theater dynamic and interactive tissue models coupled with the patient specific imagery”), [0088]-[0091]; Figs. 1-4, 14-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the disclosure of Anderson, Roh and Furrer to incorporate the teachings of Avisar and provide a surgery procedure for a robot. Avisar is directed to a system for simulating surgical procedures. Incorporating the system for simulating surgical procedures as in Avisar with the patient-specific design and manufacture of spinal implants as in Roh, the production of a patient-specific implant as in Furrer and the systems for treating spinal disorders as in Anderson would thereby improve the applicability, efficacy, and accuracy of the claimed system and method for providing patient-specific implants and devices.
Regarding claim 19, Anderson as modified by Roh and Furrer discloses all the limitations of claim 17. The references may not specifically describe but Ryan teaches generating control instructions configured to cause a surgical robot to perform, at least partly, the surgical procedure (See id.).
Regarding claims 21 and 22, claims 21 and 22 recite substantially the same limitations as recited in claims 18 and 19 and are rejected under the same grounds of rejection and reasoning as applied to claims 18 and 19, above.
Response to Arguments
Applicant’s remarks filed October 22, 2025 have been fully considered, but they are not persuasive. The following explains why:
Applicant’s arguments pertaining to prior art rejections are not persuasive/moot in light of at least new references Furrer and Avisar. See rejection above.
Applicant’s arguments pertaining to subject matter eligibility are persuasive. The rejection under 35 U.S.C. §101 has been dropped.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM T. MONTICELLO whose telephone number is (313)446-4871. The examiner can normally be reached M-Th; 08:30-18:30 EST.
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/WILLIAM T. MONTICELLO/ Examiner, Art Unit 3681
/MARC Q JIMENEZ/Supervisory Patent Examiner, Art Unit 3681