Detailed Action
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In an amendment filed on 9/17/2025 claims 2-3 and 22-30 were cancelled and the rest of the claims were amended. Therefore, Claims 1, 4-21 and 31 are still pending in this application and are subject to a restriction election.
Response to amendments/Remarks
Applicant’s election without traverse of invention/group I (claims 1-21, and 31) in the reply filed on 9/17/2025 is acknowledged. The claims were cancelled.
Applicant’s arguments on pages 11-12, with respect to rejections to claims , 1, 4-21 and 31 under 35 USC § 103 have been fully considered and are persuasive. Therefore, rejections to the claims under 35 USC § 103 have been withdrawn.
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.
Claim(s) 1, 4, 7, 9-11, 17-21 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 20100191071) in view of Casey et al (US 20190321193) and Donner et al (US 20220071644).
As per claim 1, Anderson teaches a computer-implemented method for designing a patient-specific sacroiliac implant for addressing sacroiliac dysfunction (see [0062] “…In some embodiments, the questions of step 78 are provided to the patient and/or medical personnel in an interactive computer program…”; ), the method comprising:
receiving patient data, the patient data including-
image data of a pelvic region of a patient, including at least portions of a sacrum, an ilium, and a sacroiliac joint of the patient (see [0063] “In the current embodiment, imaging techniques are utilized to evaluate the patient at step 80. For example, in some embodiments radiographic images of the patient's anatomy are obtained. The radiographic images are then analyzed to identify any medical conditions afflicting the patient. The medical conditions are then considered as a factor in evaluating the patient…”; also, see Fig 2 and see [0065] “At step 24, the patient is subjected to an imaging study. Referring more specifically to FIG. 5, shown therein is a flow chart illustrating the imaging step 24 of the method 20 according to one embodiment of the present disclosure. The imaging study includes obtaining patient images through the use of magnetic resonance imaging ("MRI"), computed tomography ("CT"), video fluoroscopy, and/or other imaging techniques at step 84…” and [0066]; also, see [0172] “…Fluoroscopy machines may be utilized to obtain real-time images of the patient's skeletal structure. In some embodiments, the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips…”), and
scores associated with dysfunction at the patient's pelvic region (see scores has been interpreted in the BRI in light of the disclosure as “pain”; also, see [0062] “…The treating physician or other medical personnel selects the spinal disorder(s) afflicting the patient using the menu 42. In other embodiments, the menu 42 includes symptoms (e.g., low back pain, limited flexion, etc.) instead of or in addition to the spinal disorders in some embodiments. A note field 44 is provided on the right hand side of the screen shot 40 allowing additional information regarding the patient to be recorded…”; and see Fig. 4 “pain in lower back”);
generating a virtual three-dimensional model of the patient's pelvic region based on the image data (see [0066] and [0067] “The data from the imaging study is provided to one or more software applications at step 86 in order to derive further information and/or new views of the imaging data. Generally suitable software packages will be capable of one or more of 2-D radiographic measurement…”; also, see [0069] “…The patient analysis step 26 continues with step 92 in which a 3-D and/or 2-D animated model of the patient's anatomy is created. Generally, the animated model is based on the data obtained from the imaging study of step 24. In some embodiments, the animated model is used to highlight the problem areas and/or times in the patient's anatomical motion sequence or motion pattern…”; also, see [0172] “…Fluoroscopy machines may be utilized to obtain real-time images of the patient's skeletal structure. In some embodiments, the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips…”; [0173] “… the method 400 continues at step 406 in which a model of the patient's relevant anatomical features is created. Generally, the data from the imaging protocol is utilized to create the model. In one particular embodiment, the data from the imaging protocol is utilized to segment the model into the individual bones of the patient. In that regard, a joint is modeled by the combination of individual bones that come together to form the joint. In some embodiments, the dimensions of the implanted sensor are known and utilized to correlate bone position to the sensor position… The model is either a 3-D or 2-D representation of the patient's anatomy. In some embodiments, the model is animated to illustrate a motion sequence of the patient's anatomy. The animated model is particular beneficial in the diagnosis and treatment of orthopedic joints. One particular method for modeling the patient's anatomy is to provide or develop a highly accurate model of a generic skeleton, and then map a model of the specific patient derived from an imaging study to the generic skeleton…”; also, see [0069-0072]; also, see [0171-0172] “…the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips, shoulders…”), the virtual three-dimensional model including at least portions of the sacrum, the ilium, and the sacroiliac joint of the patient ( see [0172] “…Fluoroscopy machines may be utilized to obtain real-time images of the patient's skeletal structure. In some embodiments, the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips…”);
based on the virtual three-dimensional model and the scores, determining one or more surgical corrections to the patient's pelvic region (see [0018] “ …Finally, the method also includes identifying at least one spinal implant with the parameter for correcting the initial problem in the motion sequence of the spinal joint…”; also, see [0059] “…model patient-specific treatment plans, plan and deliver treatment to the patient,…”; also, see [0077] “… Next, the modeling step 30 continues by modifying the 3-D and/or 2-D animated model of the patient's anatomy according to the treatment plan at step 108. For example, in some embodiments the animated model is modified by replacing a damaged portion of the patient's anatomy with an implant. A model can then be created utilizing the characteristics of the implant in place of the damaged portion of the patient's anatomy as indicated by step 108. Referring to FIG. 10, shown therein is a screen shot 52 of a software interface showing a representative figure of a modeling according the present embodiment….”; also, see [0168-0172]), wherein the one or more surgical corrections include
(1) a corrective adjustment to the relative positioning of the patient’s sacrum( [0079] “… By identifying potential problem areas and/or times in the patient's anatomical motion sequence and taking into account the tissues that will be compromised during the surgical procedure, the modeling provides a realistic estimation of the resultant outcome of the treatment plan. In that regard, the treating physician optimizes each treatment plan by modifying such factors as the size, placement, orientation, and material properties of a particular implant and/or modifying the surgical procedure to adjust the tissues that will be compromised at step 112 …”; also, see [0082] “…Generally, a physician and/or a computer system compares the modeled results and/or statistical summaries for each of the optimized plans and selects the plan best suited for correcting the patient's medical condition…”; also, see [0085] “… Further, the desired fixation positions and orientations for any fixation devices are established and marked on a model at step 128. These fixation positions and orientations are saved for future reference during the actual surgical procedure…”; also, see [0111] and [0172] “… iliac crest, sacrum…”) and
(2) fusion of the(see [0119] “…Block 220 reflects that treatment, which in the spinal orthopedic field may include open or minimally-invasive surgery, stabilization through implantation of rods, plates and/or disc prostheses, fusion of one or more vertebral levels via intervertebral cages, placement of osteogenic materials, or many other procedures…”); and
designing one or more patient-specific sized and shaped to be positioned to provide the corrective adjustment when implanted in the patient and (see [0018]; also, see [0079] “…. In that regard, the treating physician optimizes each treatment plan by modifying such factors as the size, placement, orientation, and material properties of a particular implant and/or modifying the surgical procedure to adjust the tissues that will be compromised at step 112…”; also, see [0084] “ Referring to FIG. 12, shown therein is an exemplary screen shot 54 of a software interface that may be utilized as part of step 32. In the current embodiment, a link 56 to a product information page regarding an implant designed for the patient is provided on the left hand side of the screen shot 54. In that regard, the product information page designed for the patient includes generalized information regarding the type of implant, the typical uses of the implant, specifications of the implant, success stories related to the implant, and/or other information related to the implant that would be desirable to share with a patient. A link 58 to a product information page regarding an implant designed for the physician or medical personnel is provided on the right hand side of the screen shot 54. The product information page designed for the physician includes information related to the appropriate surgical approaches available for inserting the implant, details of the preferred surgical procedure(s), specifications of the implant, available variations/models of the implant (e.g., sizes, materials, etc.), and/or other information related to the implant that would be desirable to share with the physician”; also, see [0168] “determining the appropriate prosthetic implant for a patient (e.g., shape, size, design, material, etc.); also, see “[0096], [0207]);
determining one or more (also, see [0058] “…the treatment plans discussed herein will be focused on surgical procedures,…” [0059] “In that regard, the system 10 is utilized by physicians, surgeons, medical assistants, and/or other medical personnel to diagnose motion disorders, model patient-specific treatment plans, plan and deliver treatment to the patient, acquire feedback regarding the effectiveness of the treatment, modify the treatment as needed, track patient results based on treatment plans, and/or continuously improve patient treatment by correlating successful treatment plans with specific patient symptoms or characteristics related to the motion disorders”; also, see Figs 2, 7, 8, and 28 and see [0074] “ The proposed treatment plans include surgical procedures, non-invasive treatments, and/or medicinal treatments….”; and see [0076-0079] and [0164].
While Anderson teaches that the system is used for generating a virtual three-dimensional model of the patient's anatomy including pelvic region based on images comprising pelvis, sacrum and iliac, generating a surgical plan based on the 3D model to correct a condition of the patient based on the 3D model including joints (see 0018 and 0168), and designing an implant or fixation device to correct a condition of the anatomy using an implant, Anderson does not explicitly teach determining surgical corrections, wherein the surgical corrections include (1) a corrective adjustment to the relative positioning of the patient’s sacrum and the ilium, and (2) fusion of the patient’s sacroiliac joint to maintain the corrective adjustment;
designing one or more patient-specific sacroiliac implants sized and shaped to be positioned at least partially within the patients’ sacroiliac joint, to provide the corrective adjustment when implanted in the patient and to fuse the sacroiliac joint to maintain the corrective adjustment; wherein the one or more patient-specific sacroiliac implants includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint; and determining surgical steps for implanting the one or more patient-specific sacroiliac implants within the patient’s sacroiliac joint.
However, Casey teaches a surgical planning computer implemented method (see the abstract “surgical planning software…”; also, see [0008]) comprising generating a plan comprising determining one or more surgical corrections to the patient's pelvic region (see [0008] “…a personalized fixation system includes a surgical planning software tool configured to adjust relationships of relevant anatomy of a subject, at least one bone anchor, a plate having a shape that does not conform to a single plane, the plate configured to accept the at least one bone anchor, wherein the shape of the plate is at least partially determined by the surgical planning software tool…”…and see [0010] “…a method for manufacturing a fixation system includes capturing anatomy using digital imaging software, segmenting relevant anatomy of a subject from irrelevant anatomy using the imaging software, correcting the anatomy in virtual space using surgical planning software, designing implants using software, and building implants using additive manufacturing.” Also, see [0072-0073] “… If one or more of the predictive guidelines from step 208 are not true for the spine segments selected, then a user may utilize a user interface to adjust the virtual anatomy into a preferred alignment, as shown in step 212. For example, if the pelvic tilt is determined to be 20° or greater, a user may input or toggle an adjustment that changes the amount of correction in order to achieve a pelvic tilt less than 20°. If it is determined that the predictive guidelines are all achieved (whether user adjustment was or was not required), the system generates three-dimensional implant(s) geometry in step 214. The three-dimensional implant(s) geometry may in some cases define a single interbody device”; also, see [0014]), wherein the one or more surgical corrections include (1) a corrective adjustment to the relative positioning of the patient’s sacrum and the ilium (see [0061] “. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium”; also, see [0072], [0073]), and (2) fusion of the patient’s sacroiliac joint to maintain the corrective adjustment, and designing one or more patient-specific sacroiliac implants sized and shaped to be positioned within the patient (see 0010-0011 and 0061), configured to provide the corrective adjustment (see [0010]; also, see Fig. 10 and see [0061] “Construct 110 can be used to treat patients who have a degenerative or deformative condition of the spine. In one embodiment, plate 50 is fixed to the spine using bone screws 100, 102, 104. Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine. Surgeons using traditional fixation devices (rods, screws, connectors, etc.) recognize that bending a rod to the appropriate shape for iliac fixation is difficult and often results in the use of supplemental devices that are difficult to use).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Andersons’ invention as taught above to include generating a plan comprising determining one or more surgical corrections to the patient's pelvic region, wherein the one or more surgical corrections include (1) a corrective adjustment to the relative positioning of the patient’s sacrum and the ilium, and (2) fusion of the patient’s sacroiliac joint to maintain the corrective adjustment and designing one or more patient-specific sacroiliac implants configured to provide the corrective adjustment as taught by Casey in order to generate and design personalized and customized surgical plan and fixation device or implant (see [0008-0014] “…a system for designing a fixation system includes a computational system to perform virtual surgery of a subject, an algorithm for determining optimal position of bony structures in the subject, an algorithm for determining optimal shape of the fixation system including location of nodes, bone anchors, longitudinal elements, and locking elements, an algorithm for determining optimal bone anchor length, width, start-point, and trajectory, an algorithm for determining optimal number, position, shape, density, and internal structure of implants of the fixation system, and an additive manufacturing technique to build the implants…”).
While Casey teaches implants to correct and provide the fixation to the sacrum and ilium (see [0061]), Casey does not explicitly teach the one or more sacroiliac implants sized and shaped to be positioned at least partially within the patients’ sacroiliac joint, and wherein the one or more patient-specific sacroiliac implants includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint; and determining surgical steps for implanting the one or more patient-specific sacroiliac implants within the patient’s sacroiliac joint.
However, Donner teaches a system and method comprising configuring one or more sacroiliac implants sized and shaped to be positioned at least partially within the patients’ sacroiliac joint (also, see [0148] “…the sacral, medial or first articular face of the implant may be configured to be generally convex to match the contour of a sacral auricular boney surface or to match the contour of an extra-articular region of a sacrum (e.g., a sacral fossa)… iliac or second articular face of the implant 12 may be configured to be generally concave to match the contour of an iliac auricular boney surface or to match the contour of an extra-articular region of an ilium (e.g., an iliac tuberosity)”, thus, the shape/size of the implant is configured/designed to be positioned with the SI joint; also, see [0149] and Fig. 54A; also, see [0176] “… to make cuts that match a shape of a portion of an implant that will be implanted in the joint.”; 0187 “a tooling head 52 such as seen in FIGS. 19A-19D may be useful in preparing a “keel-cut” into either or both of the sacrum or ilium such that when the implant 12 is delivered into the sacroiliac joint”; also, see [0294] “…If the surgeon selects a procedure involving delivery of an implant within the joint space, the surgeon will select an implant configuration for delivery into the sacroiliac joint of the patient based on preoperative or intraoperative data…”; see [0335] “ form opposing channels 4018 in the sacrum 1004 and the ilium 1005 that match the shape of an implant to be delivered in the surgical procedure”), and wherein the one or more patient-specific sacroiliac implants includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint (see [0148] “…first and second articular faces of the implant 12 may be selected to match the contour of the joint space of the sacroiliac joint within which the implant 12 is to be inserted. For example, the sacral, medial or first articular face of the implant may be configured to be generally convex to match the contour of a sacral auricular boney surface or to match the contour of an extra-articular region of a sacrum (e.g., a sacral fossa)…”; also, see [0149]-[0150] and Fig. 54A), and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint (see Fig. 48C and see [0148] “…As another example, the lateral, iliac or second articular face of the implant 12 may be configured to be generally concave to match the contour of an iliac auricular boney surface or to match the contour of an extra-articular region of an ilium (e.g., an iliac tuberosity). In one aspect, the lateral, iliac or second articular face of the implant 12 may be generally a surface negative of the articular surfaces 1016 of the extra-articular region 3007 and/or articular region 1044 of the ilium 1005”; also, se Fig. 53D and [0343]; also, see [0149]-[0150] and Fig. 54A ) and determining surgical steps for implanting the one or more patient-specific sacroiliac implants within the patient’s sacroiliac joint (see 0023 “may take the form of a method of surgically preparing a sacroiliac joint having a sacrum and an ilium for a surgical fusion procedure”; also, see [0293-0294] “…a surgeon or other medical person may select a suitable procedure to fuse the sacroiliac joint. The procedure may include fusing the joint with or without delivering an implant in the joint space. If the surgeon selects a procedure involving delivery of an implant within the joint space, the surgeon will select an implant configuration for delivery into the sacroiliac joint of the patient based on preoperative or intraoperative data..”; also, see [0295] “The preoperative or intraoperative data may assist in the planning and selecting of desirable anchor trajectories (e.g., starting and stopping points on patient's soft tissue and near or within bone tissue), anchor dimensions (e.g., length, diameter, head size, washer, thread pitch), implant types and dimensions, and joint preparation tool types, dimensions, and configurations. A particularly system for preparing and fusing the sacroiliac joint may be selected, for example, for a hypermobile joint, which may include an implant or fusion system that is resistant to the expected forces present at that particular patient's sacroiliac joint. The determination of fixation sufficiency may be calculated based on the patient's data and also on the performance results of various bench and/or finite element analysis (“FEA”) tested implant assembly configurations. For example, a calculated anchor and/or implant trajectory may be considered and determined from certain patient imaging and post-processing data with an overlayed implant assembly. also, see [0337] “ methods of preparing the sacroiliac joint 1000 for a surgical fusion procedure with a joint preparation tool assembly including a trial tool assembly and a cutting tool as described in reference to FIGS. 27-47.; also, see [0303] “implant delivery into the sacroiliac joint articular region 1044, reference is made to FIG. 48C, which is a close-up lateral side view of the hip region 1002 of a patient 1001 with a nearest ilium 1005 removed in order to show the sacroiliac joint boundary 3000 defined along the sacrum 1004 and outlining the sacroiliac joint articular region 1044, and an implant 25 positioned for implantation within the sacroiliac joint articular region 1044.).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson-Casey’s combination as taught above to include configuring one or more sacroiliac implants sized and shaped to be positioned at least partially within the patients’ sacroiliac joint, wherein the one or more patient-specific sacroiliac implants includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint, and determining surgical steps for implanting the one or more patient-specific sacroiliac implants within the patient’s sacroiliac joint as taught by Donner in order to design a customized sacroiliac implants for adequate and better fixation and fusion than conventional methos (see [0013] [0015]).
As per claim 4, Anderson-Casey-Donner teaches the computer-implemented method of claim 3, Casey further teaches wherein the one or more patient-specific sacroiliac implants includes a plurality of patient-specific sacroiliac fusion devices (this is not a method step for designing the implant but an intended use of the implant. However, Casey further teaches this limitations: see [0010]; also, see Fig. 10 and see [0061] “Construct 110 can be used to treat patients who have a degenerative or deformative condition of the spine. In one embodiment, plate 50 is fixed to the spine using bone screws 100, 102, 104. Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine. Surgeons using traditional fixation devices (rods, screws, connectors, etc.) recognize that bending a rod to the appropriate shape for iliac fixation is difficult and often results in the use of supplemental devices that are difficult to use.”).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Andersons’ invention as taught above to include wherein the one or more patient-specific implants includes a plurality of patient-specific sacroiliac fusion devices as taught by Casey in order to generate and design personalized and customized fixation devices or implants such as SI fusion joint devices that fuse and correct sacroiliac joints (see [0008-0014] “…a system for designing a fixation system includes a computational system to perform virtual surgery of a subject, an algorithm for determining optimal position of bony structures in the subject, an algorithm for determining optimal shape of the fixation system including location of nodes, bone anchors, longitudinal elements, and locking elements, an algorithm for determining optimal bone anchor length, width, start-point, and trajectory, an algorithm for determining optimal number, position, shape, density, and internal structure of implants of the fixation system, and an additive manufacturing technique to build the implants…”). Donner further teaches sacroiliac implants that include sacroiliac fusion devices (see [0145-0149] and [0174]).
As per claim 7, Anderson-Casey-Donner teaches the computer-implemented method of claim 1, Anderson further teaches further comprising: before determining the one or more surgical corrections to the patient's pelvic region, analyzing the virtual model and the scores to confirm the patient's pain is caused by dysfunction at the sacroiliac joint and is a candidate for corrective surgery (see [0061] “…How far can the patient walk without pain? Does the patient have pain lying down? Does the patient have pain sitting? Does the patient have pain standing? Does the patient have back pain with leg pain? If yes, is the leg pain localized or radiating? These are exemplary questions and are not to be considered limiting. Numerous other questions may be utilized to evaluate the patient. In that regard, the questions are nested such that subsequent questions depend on the answers to previous questions…”; also, see [0135] “…For example, in some embodiments where a patient complains of pain in a bony region, the data set defined by the category includes obtaining an x-ray of the problem area. Similar correlations between the patient's symptoms and the desired medical information and/or tests associated with that symptom are defined for each category…”; [0060 “…For example, in some embodiments the method 20 is based predominantly on surgical treatments. In such embodiments, the evaluation at step 22 focuses on determining whether the patient is a potential candidate for the available surgical treatments. If the evaluation at step 22 indicates that the patient is not a candidate for the available surgical treatments (e.g., due to age or other factors), then the subsequent steps of the method 20 are not performed. On the other hand, if the patient has a condition or symptom that indicates that the patient is definitely a candidate for the available surgical treatments (e.g., spondylolisthesis of grade 2 or more), then the evaluation step may either be truncated or completely skipped, and the method 20 may continue with the subsequent steps”; also, see [0064] “Based on the response to the diagnostic questions 78, imaging data 80, and/or other types of patient analysis, the patient can be grouped into a classification at step 82. A general determination can be made regarding whether the patient is a candidate for the available treatment options based on the grouping and classifications. In that regard, it is contemplated that each classification or grouping defines an inclusion group that indicates that the patient is a candidate for an available group of treatment options.”.).
As per claim 9, Anderson teaches a computer-implemented method for designing at least one patient-specific sacroiliac joint implant (see [0062] “…In some embodiments, the questions of step 78 are provided to the patient and/or medical personnel in an interactive computer program…”), the method comprising:
generating a virtual three-dimensional model of at least a portion of a spinal anatomy of a patient, including at least a portion of a sacroiliac joint, a sacrum, and an ilium of the patient (see [0066] and [0067], [0069], [0172], [0173] see [0069-0072]; also, see [0171-0172] “…the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips, shoulders…”; also, see claim 1 above );
determining a corrected configuration for at least the portion of the patient's spinal anatomy (see [0018] “ …Finally, the method also includes identifying at least one spinal implant with the parameter for correcting the initial problem in the motion sequence of the spinal joint…”; also, see [0059] “…model patient-specific treatment plans, plan and deliver treatment to the patient,…”; also, see [0077] “… Next, the modeling step 30 continues by modifying the 3-D and/or 2-D animated model of the patient's anatomy according to the treatment plan at step 108. For example, in some embodiments the animated model is modified by replacing a damaged portion of the patient's anatomy with an implant. A model can then be created utilizing the characteristics of the implant in place of the damaged portion of the patient's anatomy as indicated by step 108. Referring to FIG. 10, shown therein is a screen shot 52 of a software interface showing a representative figure of a modeling according the present embodiment….”; also, see [0168-0172);
analyzing the virtual three-dimensional model to determine a target position of the ilium and the sacrum for repositioning the patient's spinal anatomy in the corrected position (see [0079] “… By identifying potential problem areas and/or times in the patient's anatomical motion sequence and taking into account the tissues that will be compromised during the surgical procedure, the modeling provides a realistic estimation of the resultant outcome of the treatment plan. In that regard, the treating physician optimizes each treatment plan by modifying such factors as the size, placement, orientation, and material properties of a particular implant and/or modifying the surgical procedure to adjust the tissues that will be compromised at step 112 …”; also, see [0082] “…Generally, a physician and/or a computer system compares the modeled results and/or statistical summaries for each of the optimized plans and selects the plan best suited for correcting the patient's medical condition…”; also, see [0085] “… Further, the desired fixation positions and orientations for any fixation devices are established and marked on a model at step 128. These fixation positions and orientations are saved for future reference during the actual surgical procedure…”); and
designing at least one patient-specificized and shaped to be positioned (see [0018]; also, see [0079] “…. In that regard, the treating physician optimizes each treatment plan by modifying such factors as the size, placement, orientation, and material properties of a particular implant and/or modifying the surgical procedure to adjust the tissues that will be compromised at step 112…”; also, see [0084] “Referring to FIG. 12, shown therein is an exemplary screen shot 54 of a software interface that may be utilized as part of step 32. In the current embodiment, a link 56 to a product information page regarding an implant designed for the patient is provided on the left hand side of the screen shot 54. In that regard, the product information page designed for the patient includes generalized information regarding the type of implant, the typical uses of the implant, specifications of the implant, success stories related to the implant, and/or other information related to the implant that would be desirable to share with a patient. A link 58 to a product information page regarding an implant designed for the physician or medical personnel is provided on the right hand side of the screen shot 54. The product information page designed for the physician includes information related to the appropriate surgical approaches available for inserting the implant, details of the preferred surgical procedure(s), specifications of the implant, available variations/models of the implant (e.g., sizes, materials, etc.), and/or other information related to the implant that would be desirable to share with the physician”; also, see [0096], [0207]),
While Anderson teaches that the system is used for generating a virtual three-dimensional model of the patient's anatomy including pelvic region based on images comprising pelvis, sacrum and iliac, generating a surgical plan based on the 3D model to correct a condition of the patient based on the 3D model, and designing an implant or fixation device to correct a condition of the anatomy using an implant, Anderson does not explicitly teach designing at least one patient-specific sacroiliac joint implant sized and shaped to be positioned at least partially within the patients’ sacroiliac joint and coupled to the ilium and the sacrum to maintain the ilium and the sacrum in the target position, wherein the at least on patient-specific sacroiliac joint implant includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint..
However, Casey teaches a surgical planning computer implemented method (see the abstract “surgical planning software…”; also, see [0008]) comprising determining a corrected configuration for at least the portion of the patient's spinal anatomy (see [0008] “…a personalized fixation system includes a surgical planning software tool configured to adjust relationships of relevant anatomy of a subject, at least one bone anchor, a plate having a shape that does not conform to a single plane, the plate configured to accept the at least one bone anchor, wherein the shape of the plate is at least partially determined by the surgical planning software tool…”…and see [0010] “…a method for manufacturing a fixation system includes capturing anatomy using digital imaging software, segmenting relevant anatomy of a subject from irrelevant anatomy using the imaging software, correcting the anatomy in virtual space using surgical planning software, designing implants using software, and building implants using additive manufacturing.” Also, see [0072-0074] “… If one or more of the predictive guidelines from step 208 are not true for the spine segments selected, then a user may utilize a user interface to adjust the virtual anatomy into a preferred alignment, as shown in step 212. For example, if the pelvic tilt is determined to be 20° or greater, a user may input or toggle an adjustment that changes the amount of correction in order to achieve a pelvic tilt less than 20°. If it is determined that the predictive guidelines are all achieved (whether user adjustment was or was not required), the system generates three-dimensional implant(s) geometry in step 214. The three-dimensional implant(s) geometry may in some cases define a single interbody device…”; also, see [0014]), designing at least one patient-specific sacroiliac joint implant sized and shaped to be positioned within the patient and coupled to the ilium and the sacrum to maintain the ilium and the sacrum in a target position, (see [0010]-[0011] “…an algorithm for determining sizes, and shape of an implant…”; also, see Fig. 10 and see [0061] “Construct 110 can be used to treat patients who have a degenerative or deformative condition of the spine. In one embodiment, plate 50 is fixed to the spine using bone screws 100, 102, 104. Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can …be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine. Surgeons using traditional fixation devices (rods, screws, connectors, etc.) recognize that bending a rod to the appropriate shape for iliac fixation is difficult and often results in the use of supplemental devices that are difficult to use).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Andersons’ invention as taught above to include determining a corrected configuration for at least the portion of the patient's spinal anatomy, designing at least one patient-specific sacroiliac joint implant sized and shaped to be positioned and coupled to the ilium and the sacrum to maintain the ilium and the sacrum in a target position as taught by Casey in order to generate and design personalized and customized surgical plan and fixation devices or implants (see [0008-0014] “…a system for designing a fixation system includes a computational system to perform virtual surgery of a subject, an algorithm for determining optimal position of bony structures in the subject, an algorithm for determining optimal shape of the fixation system including location of nodes, bone anchors, longitudinal elements, and locking elements, an algorithm for determining optimal bone anchor length, width, start-point, and trajectory, an algorithm for determining optimal number, position, shape, density, and internal structure of implants of the fixation system, and an additive manufacturing technique to build the implants…”).
While Casey teaches implants to correct and provide the fixation to the sacrum and ilium (see [0061]), Casey does not explicitly teach the one or more sacroiliac implants sized and shaped to be positioned at least partially within the patient’s sacroiliac joint, and wherein the one or more patient-specific sacroiliac implants includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint; and determining surgical steps for implanting the one or more patient-specific sacroiliac implants within the patient’s sacroiliac joint.
However, Donner teaches a system and method comprising configuring one or more sacroiliac implants sized and shaped to be positioned at least partially within the patients’ sacroiliac joint (also, see [0148] “…the sacral, medial or first articular face of the implant may be configured to be generally convex to match the contour of a sacral auricular boney surface or to match the contour of an extra-articular region of a sacrum (e.g., a sacral fossa)… iliac or second articular face of the implant 12 may be configured to be generally concave to match the contour of an iliac auricular boney surface or to match the contour of an extra-articular region of an ilium (e.g., an iliac tuberosity)”, thus, the shape/size of the implant is configured/designed to be positioned with the SI joint; also, see [0149] and Fig. 54A; also, see [0176] “… to make cuts that match a shape of a portion of an implant that will be implanted in the joint.”; 0187 “a tooling head 52 such as seen in FIGS. 19A-19D may be useful in preparing a “keel-cut” into either or both of the sacrum or ilium such that when the implant 12 is delivered into the sacroiliac joint”; also, see [0294] “…If the surgeon selects a procedure involving delivery of an implant within the joint space, the surgeon will select an implant configuration for delivery into the sacroiliac joint of the patient based on preoperative or intraoperative data…”; see [0335] “ form opposing channels 4018 in the sacrum 1004 and the ilium 1005 that match the shape of an implant to be delivered in the surgical procedure”), and wherein the at least one patient-specific sacroiliac implant includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint,
(see [0148] “…first and second articular faces of the implant 12 may be selected to match the contour of the joint space of the sacroiliac joint within which the implant 12 is to be inserted. For example, the sacral, medial or first articular face of the implant may be configured to be generally convex to match the contour of a sacral auricular boney surface or to match the contour of an extra-articular region of a sacrum (e.g., a sacral fossa)…”; also, see [0149]-[0150] and Fig. 54A), and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint (see Fig. 48C and see [0148] “…As another example, the lateral, iliac or second articular face of the implant 12 may be configured to be generally concave to match the contour of an iliac auricular boney surface or to match the contour of an extra-articular region of an ilium (e.g., an iliac tuberosity). In one aspect, the lateral, iliac or second articular face of the implant 12 may be generally a surface negative of the articular surfaces 1016 of the extra-articular region 3007 and/or articular region 1044 of the ilium 1005”; also, se Fig. 53D and [0343]; also, see [0149]-[0150] and Fig. 54A).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson-Casey’s combination as taught above to include configuring/designing at least one patient-specific sacroiliac joint implant sized and shaped to be positioned at least partially within the patient’s sacroiliac joint and coupled to the ilium and the sacrum to maintain the ilium and the sacrum in a target position, wherein the at least one patient-specific sacroiliac implant includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint.t as taught by Donner in order to design a customized sacroiliac implants for adequate and better fixation and fusion than conventional methods (see [0013] [0015]).
As per claim 10, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, Anderson further teaches wherein analyzing the virtual three-dimensional model includes: moving the virtual three-dimensional model of the patient's spinal anatomy to the corrected configuration (see [0014], [0067], [0069] “…Generally, the animated model is based on the data obtained from the imaging study of step 24. In some embodiments, the animated model is used to highlight the problem areas and/or times in the patient's anatomical motion sequence or motion pattern. In that regard, motion sequences and/or motion patterns as the terms are used herein are intended to include a patient's gait, a portion of the patient's gait, a single movement of a single anatomical structure, a series of movements of a single anatomical structure, a single movement of a plurality of anatomical structures, a series of movements of a plurality of anatomical structures, or other aspects of a patient's motion…”, also, see [0173] “[0173] “… the method 400 continues at step 406 in which a model of the patient's relevant anatomical features is created. Generally, the data from the imaging protocol is utilized to create the model. In one particular embodiment, the data from the imaging protocol is utilized to segment the model into the individual bones of the patient. In that regard, a joint is modeled by the combination of individual bones that come together to form the joint. In some embodiments, the dimensions of the implanted sensor are known and utilized to correlate bone position to the sensor position… The model is either a 3-D or 2-D representation of the patient's anatomy. In some embodiments, the model is animated to illustrate a motion sequence of the patient's anatomy. The animated model is particular beneficial in the diagnosis and treatment of orthopedic joints. One particular method for modeling the patient's anatomy is to provide or develop a highly accurate model of a generic skeleton, and then map a model of the specific patient derived from an imaging study to the generic skeleton…”; also, see [0171-0172] “…the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips, shoulders…”; also, see [0070], [0071], [0072], [0077], [0078], [0079], [0080] “ In some embodiments the model allows for zooming, panning, or otherwise changing the orientation of the view of the patient's anatomy with the implant inserted…”);
determining the target position of the ilium and the sacrum based at least partially on the movement of the virtual three-dimensional model to the corrected configuration (see 0069 “…The patient analysis step 26 continues with step 92 in which a 3-D and/or 2-D animated model of the patient's anatomy is created. Generally, the animated model is based on the data obtained from the imaging study of step 24. In some embodiments, the animated model is used to highlight the problem areas and/or times in the patient's anatomical motion sequence or motion pattern. In that regard, motion sequences and/or motion patterns as the terms are used herein are intended to include a patient's gait, a portion of the patient's gait, a single movement of a single anatomical structure, a series of movements of a single anatomical structure, a single movement of a plurality of anatomical structures, a series of movements of a plurality of anatomical structures, or other aspects of a patient's motion.; also, see [0070], [0071], [0072], [0077], [0078], [0079]); and
identifying an implant location along the patient's sacroiliac joint based on the determined target position (see [0079] “…In that regard, the treating physician optimizes each treatment plan by modifying such factors as the size, placement, orientation, and material properties of a particular implant and/or modifying the surgical procedure to adjust the tissues that will be compromised at step 112…”; also, see [0111] “…the spinal data may be filtered down to data or studies to a particular region of the spine, such as a lumbar spine study group (LSSG), which may focus on treatments and outcomes in solely the lower back (e.g. lumbar and sacral vertebrae and associated tissue).”; also, see [0172] “…e imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, …”).
As explained above, Casey also teaches determining the target position of the ilium and the sacrum based at least partially on the movement of the virtual three-dimensional model to the corrected configuration ([0010] “…a method for manufacturing a fixation system includes capturing anatomy using digital imaging software, segmenting relevant anatomy of a subject from irrelevant anatomy using the imaging software, correcting the anatomy in virtual space using surgical planning software, designing implants using software, and building implants using additive manufacturing.” Also, see [0072-0073] “… If one or more of the predictive guidelines from step 208 are not true for the spine segments selected, then a user may utilize a user interface to adjust the virtual anatomy into a preferred alignment, as shown in step 212. For example, if the pelvic tilt is determined to be 20° or greater, a user may input or toggle an adjustment that changes the amount of correction in order to achieve a pelvic tilt less than 20°. If it is determined that the predictive guidelines are all achieved (whether user adjustment was or was not required), the system generates three-dimensional implant(s) geometry in step 214. The three-dimensional implant(s) geometry may in some cases define a single interbody device”; also, see [0014]), and identifying an implant location along the patient's sacroiliac joint based on the determined target position (see [0010]; also, see Fig. 10 and see [0061] “Construct 110 can be used to treat patients who have a degenerative or deformative condition of the spine. In one embodiment, plate 50 is fixed to the spine using bone screws 100, 102, 104. Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine. Surgeons using traditional fixation devices (rods, screws, connectors, etc.) recognize that bending a rod to the appropriate shape for iliac fixation is difficult and often results in the use of supplemental devices that are difficult to use).
As per claim 11, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, Anderson further teaches further comprising: simulating loading on the sacroiliac joint for a range of motion of a spine of the patient (see [0072] and see [0080] “Additional features as previously mentioned may be utilized to model the treatment plans. In some embodiments the model includes a stress grid overlay that indicates potential areas of increased stress or strain on the patient's anatomy, such increased muscle activity; overstretching of muscles, ligaments, and/or tendons; friction between bones; and/or other areas of stress/strain caused by the implant and/or treatment plan”; also, see [0095] “the modeling module 14 includes additional features to allow medical personnel and/or a computer system to analyze the patient. In that regard, in some embodiments the modeling module 14 creates a stress grid overlay that highlights potential areas of increased stress or strain on the patient's anatomy, such increased muscle activity; overstretching of muscles, ligaments, and/or tendons; friction between bones; and/or other areas of stress/strain. In some embodiments, the module 14 provides a user interface that allows for zooming, panning, or otherwise changing the orientation of the view of the patient's anatomy… Further, the modeling module 14 allows 3-D and/or 2D tracking of specific anatomical features through the motion sequences in some instances. In some embodiments, the modeling module 14 highlights potential problem areas for the patient based on a comparison to a standardized model associated with the patient. In that regard, the modeling module 14 is in communication with a database containing a plurality of standardized models for such use”; also, see [0179]);
determining acceptable loading for the sacroiliac joints of the patient based at least partially on the simulated loading (see [0095] “…a comparison to a standardized model associated with the patient. …”; also, see [0179]);
and comparing the acceptable loading with the simulated loading to determine whether the simulated loading is within an acceptable loading threshold (see [0095] “the modeling module 14 includes additional features to allow medical personnel and/or a computer system to analyze the patient. In that regard, in some embodiments the modeling module 14 creates a stress grid overlay that highlights potential areas of increased stress or strain on the patient's anatomy, such increased muscle activity; overstretching of muscles, ligaments, and/or tendons; friction between bones; and/or other areas of stress/strain. In some embodiments, the module 14 provides a user interface that allows for zooming, panning, or otherwise changing the orientation of the view of the patient's anatomy… Further, the modeling module 14 allows 3-D and/or 2D tracking of specific anatomical features through the motion sequences in some instances. In some embodiments, the modeling module 14 highlights potential problem areas for the patient based on a comparison to a standardized model associated with the patient. In that regard, the modeling module 14 is in communication with a database containing a plurality of standardized models for such use”; also, see [0175], [0205]; also, see [0179] “ In that regard, in some embodiments the animated model includes a stress grid overlay that indicates potential areas of increased stress or strain on the patient's anatomy, such increased muscle activity; overstretching of muscles, ligaments, and/or tendons; friction between bones; and/or other areas of stress/strain. In some embodiments the model allows for zooming, panning, or otherwise changing the orientation of the view of the patient's anatomy. A user adjusts the orientation to better observe or isolate a potential problem area. Similarly, the animated model allows a user to pause, rewind, slow down, and/or speed up simulation of a motion sequence to better observe a potential problem. Further, the animated model allows 3-D and/or 2D tracking of specific anatomical features through the motion sequences. In some embodiments, the animated model highlights potential problem areas automatically based on a comparison to a standardized model. For example, the system may identify anatomical features with a motion sequence outside of a predetermined range. In that regard, the standardized model and/or predetermined range of normal motion are at least partially defined by a general patient population).
As per claim 17, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, Anderson further teaches wherein analyzing the virtual three-dimensional model includes: modeling one or more muscles and/or ligaments associated with the patient's spinal anatomy (see [0070] “ The model of the patient's anatomy includes layers of anatomical features that are selectively included or removed. For example, in one embodiment the patient's motion anatomy is grouped into layers according to types of anatomical tissue, such as bones, cartilage, ligaments, tendons, muscles, and/or combinations thereof …”; also, see [0071]; also, see [0072] “…In that regard, in some embodiments the animated model includes a stress grid overlay that indicates potential areas of increased stress or strain on the patient's anatomy, such as increased muscle activity; overstretching of muscles, ligaments, and/or tendons…”);
predicting forces applied to the sacroiliac joint based on (i) the modeling of the muscle and ligaments (see ) and (ii) a simulated loading on the patient's spine (see [0072] “In that regard, in some embodiments the animated model includes a stress grid overlay that indicates potential areas of increased stress or strain on the patient's anatomy, such as increased muscle activity; overstretching of muscles, ligaments, and/or tendons…”; also, see [0078]; also, see [0080], [0094], [0095], [0145], [0179], and [0204]-0205]).
As per claim 18, Anderson-Casey teaches the computer-implemented method of claim 9, Anderson further teaches further comprising: simulating one or more sacroiliac joint adjustments (see [0111] “…such as a lumbar spine study group (LSSG), which may focus on treatments and outcomes in solely the lower back (e.g. lumbar and sacral vertebrae and associated tissue)…”); and
performing one or more pre-operative and/or post-operative simulations to predict a patient outcome based on the one or more simulated sacroiliac joint adjustments (see [0005] “… A simulation and/or outcome modeling of each administered treatment from the records obtained is performed to obtain a level of confidence in a particular outcome resulting from said treatment. Based on the simulation and/or outcome modeling a treatment plan for the current patient is selected. The database includes information collected from one or more medical treatment studies…”; also, see [0009], [0059]; also, see [0067] “…3-D modeling, reconstruction, and kinematic simulation; therapy modeling or simulation; and outcome simulation…”; also, see [0079]-[0081], and [0087]; also, see [0111] “… For example, continuing the STSG example, the spinal data may be filtered down to data or studies to a particular region of the spine, such as a lumbar spine study group (LSSG), which may focus on treatments and outcomes in solely the lower back (e.g. lumbar and sacral vertebrae and associated tissue). Similarly, another grouping may filter the spinal data down to data or studies by a cervical spine study group (CSSG), which may concentrate on outcomes and treatments in the upper vertebral region…”; also, see [0114] “k. This assessment, treatment and outcomes modeling software of the system 10 allows entry of data of a current patient for which a diagnosis and/or treatment options and analysis is desired…”).
Casey further teaches a simulation of sacroiliac joint adjustments (see [0061] “Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium” also, see [0080] “The method 200 may be used to simulate and construct any portion or characteristic of the plate 50, including node locations, hole locations, hole angles, longitudinal segment shape, longitudinal segment thickness, or longitudinal segment density…”).
As per claim 19, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, Casey further teaches wherein the at least one sacroiliac joint implant has a first topology configured to match a second topology of the patient's sacroiliac joint at or near the target position (see [0010]; also, see Fig. 10 and see [0061] “Construct 110 can be used to treat patients who have a degenerative or deformative condition of the spine. In one embodiment, plate 50 is fixed to the spine using bone screws 100, 102, 104. Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine. Surgeons using traditional fixation devices (rods, screws, connectors, etc.) recognize that bending a rod to the appropriate shape for iliac fixation is difficult and often results in the use of supplemental devices that are difficult to use; also, see [0054-056]; ).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s invention to include wherein the at least one sacroiliac joint implant has a first topology configured to match a second topology of the patient's sacroiliac joint at or near the target position as taught by Casey in order to in order to generate and design personalized and customized surgical plan and fixation devices or implants (see [0008-0014]) and provide fixation devices such as sacroiliac joint implants that are easily and customized to the anatomy of the patients (see [0061] “…Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium…”). Donner also teaches wherein the at least one sacroiliac joint implant has a first topology configured to match a second topology of the patient's sacroiliac joint at or near the target position (see 0148-0149).
As per claim 20, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, Casey further teaches wherein the least one sacroiliac joint implant has a first topology configured to match a second topology of a coxal bone of the patient (see [0010]; also, see Fig. 10 and see [0061] “Construct 110 can be used to treat patients who have a degenerative or deformative condition of the spine. In one embodiment, plate 50 is fixed to the spine using bone screws 100, 102, 104. Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine. Surgeons using traditional fixation devices (rods, screws, connectors, etc.) recognize that bending a rod to the appropriate shape for iliac fixation is difficult and often results in the use of supplemental devices that are difficult to use; also, see [0054-056]).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s invention to include w wherein the least one sacroiliac joint implant has a first topology configured to match a second topology of a coxal bone of the patient as taught by Casey in order to in order to generate and design personalized and customized surgical plan and fixation devices or implants (see [0008-0014]) and provide fixation devices such as sacroiliac joint implants that are easily and customized to the anatomy of the patients (see [0061] “…Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium…”). Donner also teaches wherein the least one sacroiliac joint implant has a first topology configured to match a second topology of a coxal bone (the ilium is a coxal bone) of the patient (see 0148-0149).
As per claim 21, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, further comprising: Anderson further teaches identifying one or more regions of the patient's spine for adjustment (see [0074] “…For sake of example and simplicity, a series of proposed surgical treatment plans will now be discussed in the context of a disc herniation in the lumbar region of the spine as identified by a patient analysis. This is for exemplary purposes only and should not be considered limiting in any way”; also, see [0127] “ Data from these images are taken via software, and in the illustrated embodiment 3-D modeling, measurement, and simulation software is used to generate a three-dimensional model of the patient's spine (block 274), patient measurement software is used to calculate a global balance (block 276),…”; also, see [0172] “…Fluoroscopy machines may be utilized to obtain real-time images of the patient's skeletal structure. In some embodiments, the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips…”; also, see Fig. 10); and
adjusting one or more anatomic elements of the virtual three-dimensional model at the identified one or more regions to produce the corrected configuration for the patient's spine (see [0069] “…The patient analysis step 26 continues with step 92 in which a 3-D and/or 2-D animated model of the patient's anatomy is created. Generally, the animated model is based on the data obtained from the imaging study of step 24. In some embodiments, the animated model is used to highlight the problem areas and/or times in the patient's anatomical motion sequence or motion pattern…”; also, see [0172] “…Fluoroscopy machines may be utilized to obtain real-time images of the patient's skeletal structure. In some embodiments, the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips…”; [0173] “… the method 400 continues at step 406 in which a model of the patient's relevant anatomical features is created. Generally, the data from the imaging protocol is utilized to create the model. In one particular embodiment, the data from the imaging protocol is utilized to segment the model into the individual bones of the patient. In that regard, a joint is modeled by the combination of individual bones that come together to form the joint. In some embodiments, the dimensions of the implanted sensor are known and utilized to correlate bone position to the sensor position… The model is either a 3-D or 2-D representation of the patient's anatomy. In some embodiments, the model is animated to illustrate a motion sequence of the patient's anatomy. The animated model is particular beneficial in the diagnosis and treatment of orthopedic joints. One particular method for modeling the patient's anatomy is to provide or develop a highly accurate model of a generic skeleton, and then map a model of the specific patient derived from an imaging study to the generic skeleton…”; also, see [0069-0072]; also, see [0171-0172] “…the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips, shoulders…”; also, see [0207] “Based on the analysis of the patient's motion profile at step 506, the method 500 continues at step 508 in which the treatment parameters are modified or defined in an effort to correct any problems in the motion profile…In some embodiments, the treatment parameters comprise the placement, orientation, stiffness, and/or other aspects of an implant.in some embodiments, the implant includes features that allow non-invasive adjustment of the implant. For example, in some embodiments the implant includes one or more actuators to adjust the position of the implant relative to a fixation device. In other embodiments, the implant includes one or more actuators to adjust the relative stiffness of the implant…”; also, see [0241] ).
As per claim 31, Anderson teaches a method of manufacturing a patient-specific sacroiliac fusion device for addressing sacroiliac dysfunction in a patient (see [0062] “…In some embodiments, the questions of step 78 are provided to the patient and/or medical personnel in an interactive computer program…”), the method comprising:
receiving manufacturing data for the patient-specific sacroiliac fusion device (see [0088] “…This data related to current patient's outcome is the feedback that provides confirmation of prior information and/or new information from which the medical professionals can modify the treatment plans and/or medical device manufacturers can modify the implants or devices”; also, see [0166]),
wherein the patient-specific (see [0079], [0082], [0085]). [0172] “…iliac crest, sacrum…”), and (2) fuse a (see [0119] “…Block 220 reflects that treatment, which in the spinal orthopedic field may include open or minimally-invasive surgery, stabilization through implantation of rods, plates and/or disc prostheses, fusion of one or more vertebral levels via intervertebral cages, placement of osteogenic materials, or many other procedures…”;), and
wherein the manufacturing data is generated by a process including:
generating a virtual three-dimensional model of a pelvic region of the patient including at least a portion of the sacrum, the ilium, and the sacroiliac joint (see [0172] “…Fluoroscopy machines may be utilized to obtain real-time images of the patient's skeletal structure. In some embodiments, the imaging step 404 is utilized to obtain images of the patient's spinal column, pelvis, iliac crest, sacrum, hips…”), based at least in part on the virtual three-dimensional model, determining the corrective adjustment to the relative positioning of the sacrum and the ilium (see [0018] “ …Finally, the method also includes identifying at least one spinal implant with the parameter for correcting the initial problem in the motion sequence of the spinal joint…”; also, see [0059] “…model patient-specific treatment plans, plan and deliver treatment to the patient,…”; also, see [0077] “… Next, the modeling step 30 continues by modifying the 3-D and/or 2-D animated model of the patient's anatomy according to the treatment plan at step 108. For example, in some embodiments the animated model is modified by replacing a damaged portion of the patient's anatomy with an implant. A model can then be created utilizing the characteristics of the implant in place of the damaged portion of the patient's anatomy as indicated by step 108. Referring to FIG. 10, shown therein is a screen shot 52 of a software interface showing a representative figure of a modeling according the present embodiment….”; also, see [0168-0172]), and designing the patient-specific([0079] “… By identifying potential problem areas and/or times in the patient's anatomical motion sequence and taking into account the tissues that will be compromised during the surgical procedure, the modeling provides a realistic estimation of the resultant outcome of the treatment plan. In that regard, the treating physician optimizes each treatment plan by modifying such factors as the size, placement, orientation, and material properties of a particular implant and/or modifying the surgical procedure to adjust the tissues that will be compromised at step 112 …”; also, see [0082] “…Generally, a physician and/or a computer system compares the modeled results and/or statistical summaries for each of the optimized plans and selects the plan best suited for correcting the patient's medical condition…”; also, see [0084]-[0085] “… Further, the desired fixation positions and orientations for any fixation devices are established and marked on a model at step 128. These fixation positions and orientations are saved for future reference during the actual surgical procedure…”), wherein the patient-specific fusion device is sized and shaped to be positioned (see [0018], [0079], [0084], [0168], and [0207])
While Anderson teaches that the system is used for generating a virtual three-dimensional model of the patient's anatomy including pelvic region based on images comprising pelvis, sacrum and iliac, generating a surgical plan based on the 3D model to correct a condition of the patient based on the 3D model, and designing an implant or fixation device to correct a condition of the anatomy using an implant, Anderson does not explicitly teach
wherein the implant is patient-specific sacroiliac fusion device that is configured to (1) provide a corrective adjustment to a relative position of the sacrum and ilium when implanted in the patient, and (2) fuse the sacroiliac joint to maintain the corrective adjustment;
designing the patient-specific sacroiliac fusion device to provide and maintain the corrective adjustment, wherein the patient-specific fusion device is sized and shaped to be positioned at least partially within the patient’s sacroiliac joint and includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint
converting the manufacturing data into computer-executable instructions; and using the computer-executable instructions to manufacture the patient-specific sacroiliac fusion device.
However, Casey teaches a surgical planning computer implemented method (see the abstract “surgical planning software…”; also, see [0008]) comprising generating a plan comprising determining one or more surgical corrections to the patient's pelvic region (see [0008] “…a personalized fixation system includes a surgical planning software tool configured to adjust relationships of relevant anatomy of a subject, at least one bone anchor, a plate having a shape that does not conform to a single plane, the plate configured to accept the at least one bone anchor, wherein the shape of the plate is at least partially determined by the surgical planning software tool…”…and see [0010] “…a method for manufacturing a fixation system includes capturing anatomy using digital imaging software, segmenting relevant anatomy of a subject from irrelevant anatomy using the imaging software, correcting the anatomy in virtual space using surgical planning software, designing implants using software, and building implants using additive manufacturing.” Also, see [0072-0073] “… If one or more of the predictive guidelines from step 208 are not true for the spine segments selected, then a user may utilize a user interface to adjust the virtual anatomy into a preferred alignment, as shown in step 212. For example, if the pelvic tilt is determined to be 20° or greater, a user may input or toggle an adjustment that changes the amount of correction in order to achieve a pelvic tilt less than 20°. If it is determined that the predictive guidelines are all achieved (whether user adjustment was or was not required), the system generates three-dimensional implant(s) geometry in step 214. The three-dimensional implant(s) geometry may in some cases define a single interbody device”; also, see [0014]), receiving data for a sacroiliac fusion device, wherein the implant is patient-specific sacroiliac fusion device that is configured to (1) provide a corrective adjustment to a relative position of the sacrum and ilium when implanted in the patient, (see [0072], [0073] and see [0061]), and (2) fusion of the sacroiliac joint to maintain the corrective adjustment, and designing one or more patient-specific sacroiliac implants configured to provide the corrective adjustment (see [0010]; also, see Fig. 10 and see [0061] “Construct 110 can be used to treat patients who have a degenerative or deformative condition of the spine. In one embodiment, plate 50 is fixed to the spine using bone screws 100, 102, 104. Plate 50 can be designed to accommodate anatomy. Unique shapes or configurations of plate 50 can accommodate individual patient anatomy or mechanical performance. Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine. Surgeons using traditional fixation devices (rods, screws, connectors, etc.) recognize that bending a rod to the appropriate shape for iliac fixation is difficult and often results in the use of supplemental devices that are difficult to use), converting the manufacturing data into computer-executable instructions (see [0010] “In yet another embodiment of the present disclosure, a method for manufacturing a fixation system includes capturing anatomy using digital imaging software, segmenting relevant anatomy of a subject from irrelevant anatomy using the imaging software, correcting the anatomy in virtual space using surgical planning software, designing implants using software, and building implants using additive manufacturing”; also, see [0060] “Additive manufacturing techniques such as laser sintering or electronic beam fusion can be used to build complex non-planar plates 50 with features to provide for anatomic seating or mechanical performance. Internal geometry particular to additive manufacturing… Additive manufacturing techniques may be used in some embodiments to create a particular matrix of material/void patterns or a particular series of internal support structures of the material, thus controlling stiffness or flexibility, or the proclivity for the implant to ben in one direction more than another (e.g., more flexible along an X-Y plane than along an X-Z planet, etc”; also, see [0075] “he patient prescription containing volumes of implant(s) may comprise one or more three-dimensional files that are used in additive manufacturing, including, but not limited to: .AMF, .X3D, Collada (Collaborative Design Activity), .STL, .STP, .STEP, or .OBJ. The patient prescription may alternatively comprise one or more three dimensional files, including, but not limited to: .IGS, .STP, .STEP, .3ds, .blend, .dae, .ipt, ,skp, .fbx, .lwo, .off, .ply., .sldprt, .sldasm, and .X_T.”; also, see [0076]) and using the computer-executable instructions to manufacture the patient-specific sacroiliac fusions device (see [0010] and [0060], [0075-0076]).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Andersons’ invention as taught above to include generating a plan comprising determining one or more surgical corrections to the patient's pelvic region, wherein the implant is patient-specific sacroiliac fusion device that is configured to (1) provide a corrective adjustment to a relative position of the sacrum and the ilium of the patient when implanted in the patient, and (2) fuse the sacroiliac joint to maintain the corrective adjustment, designing the patient-specific sacroiliac fusion device to provide and maintain the corrective adjustment, converting the manufacturing data into computer-executable instructions, and using the computer-executable instructions to manufacture the patient-specific sacroiliac fusion device as taught by Casey in order to generate, design, and manufacture personalized and customized surgical plan and fixation device or implant (see [0008-0014] “…a system for designing a fixation system includes a computational system to perform virtual surgery of a subject, an algorithm for determining optimal position of bony structures in the subject, an algorithm for determining optimal shape of the fixation system including location of nodes, bone anchors, longitudinal elements, and locking elements, an algorithm for determining optimal bone anchor length, width, start-point, and trajectory, an algorithm for determining optimal number, position, shape, density, and internal structure of implants of the fixation system, and an additive manufacturing technique to build the implants…”).
While Casey teaches implants to correct and provide the fixation to the sacrum and ilium (see [0061]), Casey does not explicitly teach wherein the patient-specific fusion device is sized and shaped to be positioned at least partially within the patient’s sacroiliac joint and includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint.
However, Donner teaches a system and method comprising configuring a patient-specific fusion device sized and shaped to be positioned at least partially within the patients’ sacroiliac joint (also, see [0148] “…the sacral, medial or first articular face of the implant may be configured to be generally convex to match the contour of a sacral auricular boney surface or to match the contour of an extra-articular region of a sacrum (e.g., a sacral fossa)… iliac or second articular face of the implant 12 may be configured to be generally concave to match the contour of an iliac auricular boney surface or to match the contour of an extra-articular region of an ilium (e.g., an iliac tuberosity)”, thus, the shape/size of the implant is configured/designed to be positioned with the SI joint; also, see [0149] and Fig. 54A; also, see [0176] “… to make cuts that match a shape of a portion of an implant that will be implanted in the joint.”; 0187 “a tooling head 52 such as seen in FIGS. 19A-19D may be useful in preparing a “keel-cut” into either or both of the sacrum or ilium such that when the implant 12 is delivered into the sacroiliac joint”; also, see [0294] “…If the surgeon selects a procedure involving delivery of an implant within the joint space, the surgeon will select an implant configuration for delivery into the sacroiliac joint of the patient based on preoperative or intraoperative data…”; see [0335] “ form opposing channels 4018 in the sacrum 1004 and the ilium 1005 that match the shape of an implant to be delivered in the surgical procedure”), wherein the patient-specific sacroiliac fusion device is configured to (1) provide a corrective adjustment to a relative position of a sacrum and an ilium of the patient when implanted in the patient and (2) fuse a sacroiliac joint of the patient to maintain the corrective adjustment (see 0144, 0298-0301), and wherein the at least one patient-specific sacroiliac implant includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint, (see [0148] “…first and second articular faces of the implant 12 may be selected to match the contour of the joint space of the sacroiliac joint within which the implant 12 is to be inserted. For example, the sacral, medial or first articular face of the implant may be configured to be generally convex to match the contour of a sacral auricular boney surface or to match the contour of an extra-articular region of a sacrum (e.g., a sacral fossa)…”; also, see [0149]-[0150] and Fig. 54A), and a second patient-specific surface contoured to match a surface of the ilium that defines a portion of the patient’s sacroiliac joint (see Fig. 48C and see [0148] “…As another example, the lateral, iliac or second articular face of the implant 12 may be configured to be generally concave to match the contour of an iliac auricular boney surface or to match the contour of an extra-articular region of an ilium (e.g., an iliac tuberosity). In one aspect, the lateral, iliac or second articular face of the implant 12 may be generally a surface negative of the articular surfaces 1016 of the extra-articular region 3007 and/or articular region 1044 of the ilium 1005”; also, se Fig. 53D and [0343]; also, see [0149]-[0150] and Fig. 54A).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson-Casey’s combination as taught above to include configuring/designing configuring a patient-specific fusion device sized and shaped to be positioned at least partially within the patients’ sacroiliac joint, wherein the patient-specific sacroiliac fusion device is configured to (1) provide a corrective adjustment to a relative position of a sacrum and an ilium of the patient when implanted in the patient and (2) fuse a sacroiliac joint of the patient to maintain the corrective adjustment, and wherein the at least one patient-specific sacroiliac implant includes: a first patient -specific surface contoured to match a surface of the sacrum that defines a portion of the patient’s sacroiliac joint as taught by Donner in order to design a customized sacroiliac implants for adequate and better fixation and fusion than conventional methods (see [0013] [0015]).
Claim(s) 5 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 20100191071) in view of Casey et al (US 20190321193) and Donner et al (US 20220071644) as applied to claim 1 and 9 respectively above, and further in view of Shalayev et al (US 20190290361).
As per claim 5, Anderson-Casey-Donner teaches the computer-implemented method of claim 1, Anderson-Casey does not explicitly teach further comprising: predicting a post-operative shear force that will be applied to the patient-specific implant once the patient-specific implant is implanted in the patient; and designing the patient-specific implant to withstand a shear force that is at least 50% greater than the predicted post-operative shear force.
However, Shalayev teaches a system and method for designing and simulating implants (see [0007]) comprising predicting a post-operative shear force that will be applied to the patient-specific implant once the patient-specific implant is implanted in the patient (see [0027] “…loading conditions experienced on the surrounding bone after implant placement that may prompt bone remodeling and affect bone density….”; see [0033] “In a specific embodiment, with reference to FIG. 2, loading conditions are simulated after the user augments the initial implant design with the one or more features (Block 20). Finite element analysis (FEA) is executed that models and simulates the normal or worst case physiological loads that the implant will experience in vivo. The FEA may simulate loading conditions for different forms of physical activity such as standing, walking, running, carrying loads, pushing and pulling loads, chewing, and the like using kinematic modelling… . A distribution map of the loading conditions is readily displayed to indicate the bone regions that will experience loads after implant placement. The GUI may have options to view the loading conditions for different forms of physical activity or display an average of the compiled loads experienced during a wide variety or spectrum of the physical activities”; also, see [0071] “…The position and orientation of the retaining components are also designed to improve the stability of the implant to account for the shear forces and other loading conditions experienced on the tibial components in vivo….”), and designing the patient-specific implant to withstand the predicted shear force (see Fig. 2 and see [0038] “…Once the stability conditions are achieved the final implant design or fabrication instructions are sent to a manufacturer for fabrication (Block 18)…”; also, see [0039]; also, see [0043] “…In certain instances it may be desirable to fabricate the implant with two or more materials to achieve the desired performance criteria and improved stability…”; also, see [0071]-[0072]; also, see [0074] “…initial design… , the user first designs an initial implant 229 that can replace the region that will be removed to decompress the spinal cord and excise the tumors. Subsequently, the user identifies stability regions 230 near the initial implant interface using a bone density map 228 as shown in FIG. 9B. FIG. 9C illustrates a loading/stress map 236 on the bottom endplate of the upper vertebra 224a from an FEA performed on the subject's spine with the initial implant 229 in place….”; [0076] “FIG. 9E illustrates an example of a final implant 242. Preferably, the final implant 242 is made of PEKK because of its biocompatibility and superior compressive mechanical properties to withstand the pressures of the spine….”).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include simulating implants characteristic comprising predicting a post-operative shear force that will be applied to the patient-specific implant once the patient-specific implant is implanted in the patient, and designing the patient-specific implant to withstand the predicted shear force as taught by Shalayev in order to design an augmented and improved implant to improve implant stability (see [0007], [0018] and [0021]).
Anderson-Casey-Donner-Shalayev discloses the claimed invention except for designing the patient-specific implant to withstand a shear force that is at least 50% greater than the predicted post-operative shear force.
However, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains, to have designed the patient-specific implant to withstand a shear force that is at least 50% greater than the predicted post-operative shear force in order to improve the performance of the implant and avoid failure of the implant since designing the implant to withstand forces at the same predicted shear force for a person after surgery will cause the implant to break/fail, and would have involved a mere change in size or composition of the component/implant. It has been held in court that changing the size, shape, or proportion of ingredients to make a device stronger is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), and see MPEP 2144.04 IV A-C). Furthermore, The applicant has not disclosed that having a designed implant explicitly above 50% of a predicted shear force solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with an implant designed to withstand shear forces above any maximum predicted shear force including values of 110%, 120%, 130%, 180% and so on.
As per claim 15, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, Anderson-Casey does not explicitly teach wherein analyzing the virtual three-dimensional model includes predicting a post-operative compressive force and/or a post-operative shear force in the sacroiliac joint.
However, Shalayev teaches a system and method for designing and simulating implants (see [0007]) comprising wherein analyzing the virtual three-dimensional model includes predicting a post-operative compressive force and/or a post-operative shear force in the sacroiliac joint (see [0027] “…loading conditions experienced on the surrounding bone after implant placement that may prompt bone remodeling and affect bone density….”; see [0033] “In a specific embodiment, with reference to FIG. 2, loading conditions are simulated after the user augments the initial implant design with the one or more features (Block 20). Finite element analysis (FEA) is executed that models and simulates the normal or worst case physiological loads that the implant will experience in vivo. The FEA may simulate loading conditions for different forms of physical activity such as standing, walking, running, carrying loads, pushing and pulling loads, chewing, and the like using kinematic modelling… . A distribution map of the loading conditions is readily displayed to indicate the bone regions that will experience loads after implant placement. The GUI may have options to view the loading conditions for different forms of physical activity or display an average of the compiled loads experienced during a wide variety or spectrum of the physical activities”; also, see [0071] “…The position and orientation of the retaining components are also designed to improve the stability of the implant to account for the shear forces and other loading conditions experienced on the tibial components in vivo….”; see Fig. 2 and see [0038] “…Once the stability conditions are achieved the final implant design or fabrication instructions are sent to a manufacturer for fabrication (Block 18)…”; also, see [0039]; also, see [0043] “…In certain instances it may be desirable to fabricate the implant with two or more materials to achieve the desired performance criteria and improved stability…”; also, see [0071]-[0072]; also, see [0074] “…initial design… , the user first designs an initial implant 229 that can replace the region that will be removed to decompress the spinal cord and excise the tumors. Subsequently, the user identifies stability regions 230 near the initial implant interface using a bone density map 228 as shown in FIG. 9B. FIG. 9C illustrates a loading/stress map 236 on the bottom endplate of the upper vertebra 224a from an FEA performed on the subject's spine with the initial implant 229 in place….”; [0076] “FIG. 9E illustrates an example of a final implant 242. Preferably, the final implant 242 is made of PEKK because of its biocompatibility and superior compressive mechanical properties to withstand the pressures of the spine….”).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include simulating implants characteristic comprising wherein analyzing the virtual three-dimensional model includes predicting a post-operative compressive force and/or a post-operative shear force in the sacroiliac joint as taught by Shalayev in order to design an augmented and improved implant to improve implant stability (see [0007], [0018] and [0021]).
As per claim 16, Anderson-Casey-Donner-Shalayev teaches the computer-implemented method of claim 15, Shalayev further teaches wherein designing the patient-specific sacroiliac joint implant includes designing the sacroiliac joint to withstand a compressive force and/or a shear force(see [0033] “Finite element analysis (FEA) is executed that models and simulates the normal or worst case physiological loads that the implant will experience in vivo. The FEA may simulate loading conditions for different forms of physical activity such as standing, walking, running, carrying loads, pushing and pulling loads, chewing, and the like using kinematic modelling. see Fig. 2 and see [0038] “…Once the stability conditions are achieved the final implant design or fabrication instructions are sent to a manufacturer for fabrication (Block 18)…”; also, see [0039]; also, see [0043] “…In certain instances it may be desirable to fabricate the implant with two or more materials to achieve the desired performance criteria and improved stability…”; also, see [0071]-[0072]; also, see [0074] and [0076]).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include wherein designing the patient-specific sacroiliac joint implant includes designing the sacroiliac joint to withstand a compressive force and/or a shear force as taught by Shalayev in order to design an augmented and improved implant to improve implant stability (see [0007], [0018] and [0021]).
Anderson-Casey-Donner-Shalayev discloses the claimed invention except for designing the sacroiliac joint to withstand a compressive force and/or a shear force that is at least 50% greater than the predicted post- operative compressive force and/or the predicted post-operative shear force.
However, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains, to have designed the patient-specific implant to withstand a shear force that is at least 50% greater than whichever of the first post-operative shear force or the second post-operative shear force is greater in order to improve the performance of the implant and avoid failure of the implant because designing the implant to withstand forces at the same predicted shear force for a person after surgery will cause the implant to break/fail, and would have involved a mere change in size or composition of the component/implant. It has been held in court that changing the size, shape, or proportion of ingredients to make a device stronger is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), and see MPEP 2144.04 IV A-C). Furthermore, The applicant has not disclosed that having a designed implant explicitly above 50% of a predicted shear force solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with an implant designed to withstand shear forces above any maximum predicted shear force including values of 110%, 120%, 130%, 180% and so on.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 20100191071) in view of Casey et al (US 20190321193), Donner et al (US 20220071644) and Shalayev et al (US 20190290361) as applied to claim 5 above, and further in view of Larson et al (US 20160296159).
As per claim 6, Anderson-Casey-Donner-Shalayev teaches the computer-implemented method of claim 5, Shalayev further teaches wherein predicting the post- operative shear force includes predicting a first post-operative shear force when the patient is standing (see [0033] “Finite element analysis (FEA) is executed that models and simulates the normal or worst case physiological loads that the implant will experience in vivo. The FEA may simulate loading conditions for different forms of physical activity such as standing, walking, running, carrying loads, pushing and pulling loads, chewing, and the like using kinematic modelling.) and designing the patient-specific implant to withstand the predicted shear force when the patient is standing (see Fig. 2 and see [0038] “…Once the stability conditions are achieved the final implant design or fabrication instructions are sent to a manufacturer for fabrication (Block 18)…”; also, see [0039]; also, see [0043] “…In certain instances it may be desirable to fabricate the implant with two or more materials to achieve the desired performance criteria and improved stability…”; also, see [0071]-[0072]; also, see [0074] and [0076]).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include wherein predicting the post- operative shear force includes predicting a first post-operative shear force when the patient is standing and designing the patient-specific implant to withstand the predicted shear force when the patient is standing as taught by Shalayev in order to design an augmented and improved implant to improve implant stability (see [0007], [0018] and [0021]).
Anderson-Casey- Donner-Shalayev does not explicitly teach wherein predicting the post-operative shear force includes a second post-operative shear force when the patient is sitting, and wherein the patient-specific implant is designed to withstand a shear force that is at least 50% greater than whichever of the first post-operative shear force or the second post-operative shear force is greater.
Larson teaches a method for monitoring medical conditions comprising predicting a shear force includes a second post-operative shear force when the patient is sitting (see [0058], [0126] “By knowing the orientation of the patient's pelvis and/or thorax, the surface pressure distribution across other body structures can be estimated. For example, if it is determined that a patient is in a completely supine orientation, it is then known that surface pressure is being exerted on the patient's sacrum, and ischium”; also, see [0153], [0158]; see [0268] “…Shear forces can be estimated by knowing the orientation of the patient and/or the position of the support surface on which the patient is lying or sitting.”; also, see [0269]).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include predicting a shear force includes a second post-operative shear force when the patient is sitting as taught by Larson in order to monitor an/or estimate shear forces acting on parts of the body when sitting or standing up, and transmit said data (see [0269] “...A map of shear forces along the support surface or on the skin of the user can be generated to monitor shear forces”).
Anderson-Casey-Donner-Shalayev-Larson discloses the claimed invention except for wherein the patient-specific implant is designed to withstand a shear force that is at least 50% greater than whichever of the first post-operative shear force or the second post-operative shear force is greater.
However, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains, to have designed the patient-specific implant to withstand a shear force that is at least 50% greater than whichever of the first post-operative shear force or the second post-operative shear force is greater in order to improve the performance of the implant and avoid failure of the implant because designing the implant to withstand forces at the same predicted shear force for a person after surgery will cause the implant to break/fail, and would have involved a mere change in size or composition of the component/implant. It has been held in court that changing the size, shape, or proportion of ingredients to make a device stronger is generally recognized as being within the level of ordinary skill in the art (In re Rose, 105 USPQ 237 (CCPA 1955), and see MPEP 2144.04 IV A-C). Furthermore, The applicant has not disclosed that having a designed implant explicitly above 50% of a predicted shear force solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with an implant designed to withstand shear forces above any maximum predicted shear force including values of 110%, 120%, 130%, 180% and so on.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 20100191071) in view of Casey et al (US 20190321193) and Donner et al (US 20220071644) as applied to claim 7 above, and further in view of Daley et al (US 220180233222, cited in IDS).
As per claim 8, Anderson-Casey-Donner teaches the computer-implemented method of claim 7, but it does not explicitly teach wherein analyzing the virtual model and the scores includes using a trained machine learning model, wherein the machine learning model was trained based on previous patient virtual models, pain scores, and surgical outcomes.
However, Daley teaches a surgical planning system comprising wherein analyzing a virtual model and a scores includes using a trained machine learning model (see [0019] “The method may also include displaying a virtual model to a surgeon including displaying an augmented reality of the surgical procedure. The algorithm may include the aggregation of preoperative plans, surgical measurements, and patient outcomes stored on the server from prior surgical procedures involving patients who share at least one common feature with the individual patient. The algorithm may include analysis of preoperative plans, surgical measurements, and patient outcomes stored on the server from prior surgical procedures involving patients who shares at least one common feature with the individual patient, wherein the analysis includes using Statistical Natural Language Processing (SNLP), Bayesian aggregation, Machine learning, artificial intelligence, self-learning, Neural Networks, Deep recurrent neural networks, basic reinforcement learning, and deep reinforcement learning... ”), wherein the machine learning model was trained based on previous patient virtual models, pain scores, and surgical outcomes (see Fig. 1 and Fig. 3; also, see [0019] “…The algorithm may include analysis of preoperative plans, surgical measurements, and patient outcomes stored on the server from prior surgical procedures involving patients who shares at least one common feature with the individual patient, …”; also, see [0022] “…The method may also include creating an implant design and/or prosthesis design using medical images of the patient and an algorithm that includes the aggregation of preoperative plans, surgical measurements, medical images, and patient outcomes stored on the server from prior surgical procedures involving patients who shares at least one common feature with the individual patient.”; also, see [0047] “…This templating may be informed by machine learning to optimize for fewest number of later revisions to preoperative plan needed and for the best clinical outcome with fewest complications as indicated by block 200… In addition, after a preoperative plan has been executed in the operating room, patient results are collected by standardized outcome instruments, by patient reported outcomes, by sensors or by physician assessment as indicated by block 500. These assessments may include reports on complications, pain, range of motion, stability of the joint, longevity of the implant”; also, see [0036] “… machine learning) uses the aggregated data of previous preoperative plans of similar preoperative data cases, revisions of those similar plans, and the clinical outcome of those similar patients, and produces a preoperative plan that differs from traditional mechanical axis strategy…”).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include wherein analyzing the virtual model and the scores includes using a trained machine learning model, wherein the machine learning model was trained based on previous patient virtual models, pain scores, and surgical outcomes as taught by Danley in order to optimize and determine a new hierarchy of decisions for preoperative planning for subsequent patients who share specific common features tracked by the system and method to best achieve the desired outcome (see [0008]) and decrease the operative time, which as a result , limits the time the patient has to be under anesthesia, which decreases cardiac and pulmonary risk, which shortens the time the wound is open, and decreases the risk of infection (see 0036).
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 20100191071) in view of Casey et al (US 20190321193) and Donner et al (US 20220071644) as applied to claim 9 above, and further in view of Nawana et al (US 20140081659, cited in IDS).
As per claim 12, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, further comprising: Anderson further teaches receiving patient pain data (see (see [0061] “…How far can the patient walk without pain? Does the patient have pain lying down? Does the patient have pain sitting? Does the patient have pain standing? Does the patient have back pain with leg pain? If yes, is the leg pain localized or radiating? These are exemplary questions and are not to be considered limiting. Numerous other questions may be utilized to evaluate the patient; also, see [0062] “…In other embodiments, the menu 42 includes symptoms (e.g., low back pain, limited flexion, etc.) instead of or in addition to the spinal disorders in some embodiments…”);
determining one or more adjustments to the virtual three-dimensional model of the patient's spinal anatomy based at least partially on the received patient pain data (see [0135] “…For example, in some embodiments where a patient complains of pain in a bony region, the data set defined by the category includes obtaining an x-ray of the problem area. Similar correlations between the patient's symptoms and the desired medical information and/or tests associated with that symptom are defined for each category…”; also, see [0137]; also, see Fig. 21 pain data is collected in step 324, which includes pain data, steps 326-338 includes planning, analysis of images or 3D models, adjustments to the model based on the data received; see [0156] “… In that regard, in some embodiments the answers to questions included in the item list for categorizations are input directly into the relevant software application. With respect to the imaging data, in some embodiments the data from the imaging is provided to one or more software applications in order to derive further information and/or new views of the imaging data. Various brands or types of software for obtaining, analyzing, or otherwise handling patient data may be used for one or more of the data categories. Also, multiple software applications may be applied to a given set of item data. … In some embodiments, these software applications transform the raw images into mathematical or other forms that can be utilized by other software applications and/or manipulated via a computer system and compared to other images and/or other data sets” also, see [0157] “…In some embodiments, the analysis of the data includes creating a 3-D and/or 2-D animated model of the patient's anatomy. This model may be visually represented, such as on a computer screen or otherwise, in some embodiments. Generally, the animated model is substantially based on the data obtained in step 306. In some embodiments, the animated model is used to highlight the problem areas and/or times in the patient's anatomical motion sequence….The animated model then analyzes motion according to each grouping of anatomical tissue and the interactions therebetween.”; also, see [0159],); and
However, Anderson-Casey-Donner does not explicitly teach determining a pain reduction score based on the one or more spinal adjustments prior to manufacturing the at least one patient-specific sacroiliac joint.
Nawana teaches a computer method for generating a surgical plan and implants (see [0149] “…the treatment options module 212 can be configured to analyze data gathered by the diagnosis module 210 and/or the treatment compliance module 216, discussed further below, and determine whether the patient's mobility has improved by a certain degree after a certain amount of time as indicated by reported pain levels and/or analysis of captured images. Before the treatment options module 212 suggests one or more invasive treatment options following determination that a non-surgical treatment is not achieving a desired outcome, the treatment options module 212 can be configured to first suggest one or more other non-surgical treatments…”) comprising determining a pain reduction score based on the one or more spinal adjustments prior to manufacturing the at least one patient-specific sacroiliac joint (see [0032] “the diagnosis and treatment module receiving the information regarding the plurality of symptoms can include receiving data from a neural mapping device. The diagnosis and treatment module can measure a pain level of the patient by comparing the patient's neural map and associated self-described pain scores to a plurality of neural maps regarding a plurality of other patients and to a plurality of self-described pain scores of the plurality of other patients, thereby allowing the diagnosis and treatment module to normalize the self-described pain levels of the patient and the plurality of other patients. For another example, the diagnosis and treatment module can provide a historical success rate for each of the plurality of available surgical treatments. For yet another example, the diagnosis and treatment module can provide access to one or more knowledge sources regarding the recommended invasive treatment”, the spinal adjustments is part of treatments plans, wherein the treatment plan includes manipulation of models; also, see [0029] “…The pre-op module allows a three-dimensional electronic simulation of the selected invasive treatment to be performed on a virtual patient using a plurality of virtual instruments. The virtual patient is a model of the patient based on gathered medical data regarding the patient, and each of the plurality of virtual instruments are modeled on an actual instrument available for use in the selected invasive treatment…”; also, see [0042] “For still another example, the determined variance can include at least one of surgical instrument being moved relative to the patient than in the actual performance of the surgical procedure different than in the virtual performance of the surgical procedure, a surgical implant being used in the actual performance of the surgical procedure being implanted at a different location within the patient than the surgical implant used in the virtual performance of the surgical procedure, different radiation exposures in the actual performance of the surgical procedure and the virtual performance of the surgical procedure, different lengths of tissue retraction time in the actual performance of the surgical procedure and the virtual performance of the surgical procedure”; also, see [0143], [0174], [0242]).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include determining a pain reduction score based on the one or more spinal adjustments prior to manufacturing the at least one patient-specific sacroiliac joint as taught by Nawana in order to select the best treatment and implant that reduces pain (see [0174] and [0180], [0187] “…The 3D image(s), e.g., a plurality of images from different angles, can be subsequently evaluated at any time by a surgeon or other medical staff to determine an appropriate custom implant for the patient, which can then be ordered for availability during surgery”; also, see [0031]).
Claim(s) 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson et al (US 20100191071) in view of Casey et al (US 20190321193) and Donner et al (US 20220071644) as applied to claim 9 above, and further in view of Roh et al (US 20190146458).
As per claim 13, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, Casey teaches method including the simulation and design of a sacroiliac joint to a coxal bone of the patient (see [0080] and see [0061] “Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine), but Anderson-Casey does not explicitly teach further comprising performing, using the virtual three-dimensional model, a biomechanical simulation of spinal load transfer via the sacroiliac joint to a coxal bone of the patient.
Roh teaches a system and computer method comprising using a virtual three-dimensional model, a biomechanical simulation of spinal load transfer via a joint to a coxal bone of the patient (see [0128] “A virtual model can also analyze mechanical interaction between a patient's vertebrae, loading of implants, and other devices (e.g., rods, ties, brackets, plates, etc.) coupled to those implants. The output of these analyses can be used to select pedicle screw configurations, insertion trajectories, and placement location to optimize screw pull-out strength, maximum allowable loading (e.g., axial loads, shear loads, moments, etc.) to manage stresses between adjacent vertebrae, or maximum allowable stress in regions of the bone at risk for fracture”; also, see [0059]; also, see [0064] “… For example, the implants can be fixation device, joint replacements, hip implants, removable bone screws, stents, …”; also, see [0005] “… sacroiliac joint violation…”).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include using a virtual three-dimensional model, a biomechanical simulation of spinal load transfers taught by Roh via the sacroiliac joint to a coxal bone of the patient as taught by Anderson-Casey in order to refine the selection of implants, implant components, implant type or implantation site, (see [0059]).
As per claim 14, Anderson-Casey-Donner teaches the computer-implemented method of claim 9, further comprising Casey teaches method including the simulation and design of a sacroiliac joint to a coxal bone of the patient (see [0080] and see [0061] “Plate 50 can additionally, or alternatively be configured to provide fixation to the sacrum and/or ilium. Sacral screw 102 and iliac screw 100 can provide fixation to areas outside of the spine), but Anderson-Casey does not explicitly teach further comprising performing a biomechanical simulation of spinal load transfer via the sacroiliac joint to a coxal bone of the patient.
Roh teaches a system and computer method comprising using a virtual three-dimensional model, performing a biomechanical simulation of spinal load transfer via a joint to a coxal bone of the patient (see [0128] “A virtual model can also analyze mechanical interaction between a patient's vertebrae, loading of implants, and other devices (e.g., rods, ties, brackets, plates, etc.) coupled to those implants. The output of these analyses can be used to select pedicle screw configurations, insertion trajectories, and placement location to optimize screw pull-out strength, maximum allowable loading (e.g., axial loads, shear loads, moments, etc.) to manage stresses between adjacent vertebrae, or maximum allowable stress in regions of the bone at risk for fracture”; also, see [0059]; also, see [0064] “… For example, the implants can be fixation device, joint replacements, hip implants, removable bone screws, stents, …”; also, see [0005] “… sacroiliac joint violation…”).
Therefore, it would have been obvious to one of ordinary skilled in the art before effective filing date of the claimed invention to which said subject matter pertains to have modified Anderson’s combination as taught above to include using a virtual three-dimensional model, a biomechanical simulation of spinal load transfers taught by Roh via the sacroiliac joint to a coxal bone of the patient as taught by Anderson-Casey-Donner in order to refine the selection of implants, implant components, implant type or implantation site, (see [0059]).
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.
The prior art made of record and not relied upon, as cited in PTO form 892, is considered pertinent to applicant's disclosure.
Trieu (US 20110184518) teaches a SI joint implant partially implanted within the SI joint (see Fig. 3 and see 0045).
Donner et al (US 20190209011) teaches method and system for diagnosing and treating sacroiliac joint disorder, wherein an SI implant is implanted within the Si joint, wherein the implant surfaces matches the ilium and sacrum for fusion (see 0167).
Reckling et al (US 20180104071) teaches a SI joint implant partially implanted within the SI joint (see 0011).
When responding to this Office Action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. Applicant must also show how the amendments avoid or differentiate from such references or objections. See 37 CFR 1.111 (c).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Robert Fennema, can be reached at (571) 272-2748. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/O. L./
Examiner, Art Unit 2117
/ROBERT E FENNEMA/Supervisory Patent Examiner, Art Unit 2117
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