Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
The United States Patent & Trademark Office appreciates the application that is submitted by the inventor/assignee. The United States Patent & Trademark Office reviewed the following application and has made the following comments below.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. AU2020900651, filed on 03/04/2020.
Amendment
Applicant submitted amendments on 05/01/2026. The Examiner acknowledges the amendment and has reviewed the claims accordingly.
Overview
Claims 1-3, 6-7, 9-10, 13-14, 16-18, 21, and 24-26 are pending in this application and have been considered below.
Claims 4, 5, 19, and 20 have been cancelled.
Claims 1-3, 6-7, 9-10, 13-14, 16-18, 21, and 24-26 are rejected.
Applicants Arguments
In regards to Argument 1, Applicant/s state/s that the specification has been amended to correct typographical errors in paragraphs [0048], [0085], and [0130] and therefore the objections to the specification should be withdrawn.
In regards to Argument 2, Applicant/s state/s “Claim 26 is rejected under 35 U.S.C. 101 because the claimed invention is allegedly directed to non-statutory subject matter. While Applicant respectfully disagrees with this rejection, for reasons unrelated to patentability and in an effort to advance prosecution, Applicant has amended the claims herein. Claim 26 is amended to recite "[a] non-transitory computer-readable storage medium…" as suggested by the examiner.” Therefore the 35 U.S.C. 101 rejection of claim 26 be withdrawn.
In regards to Argument 3, Applicant/s state/s “Neither reference, alone or in combination, teaches or suggests determining an intraoperative simulated performance metric by performing a kinematic analysis on an updated digital three- dimensional model that has been modified to reflect the actual implanted pose of the implant component as determined from the registration step. Neither Boddington nor Hughes discloses or suggests claim 1 as a whole, or a combination of the elements noted above. For at least the reasons given above, Applicant submits that a prima facie case for obviousness of claims 1, 16, and 26 cannot be made over Boddington and Hughes. Claims 1, 16, and 26 are therefore in condition for allowance over Boddington and Hughes. Claims 6, 9, 13, 14, 21, 24, and 25, are also in condition for allowance as being dependent on allowable base claims.”
In regards to Argument 4, Applicant/s state/s “Claims 2, 3, 7, 10, 17, and 18 are further rejected under § 103 as being unpatentable over Boddington in view of Hughes, in further view of McKinnon US2020/0275976 (hereinafter "McKinnon"). Claims 2, 3, 7, 10, 17, and 18 are dependent on claims 1 or 16, which were shown above to be in condition for allowance over Boddington in view of Hughes. McKinnon does not cure the deficiencies of Boddington in view of Hughes. Therefore claims 1, 16, and 26 remain in condition for allowance over Boddington in view of Hughes, in further in view of McKinnon. Claims 2, 3, 7, 10, 17, and 18 are also in condition for allowance as being dependent on allowable base claims. Applicant respectfully requests that the section 103 rejections be withdrawn.”
Response to Arguments
In response to Argument 1, see remarks, filed 05/01/2026, with respect to the objections to the specification, have been fully considered and are persuasive, therefore, the objections to the specification are withdrawn.
In response to Argument 2, see remarks, filed 05/01/2026, with respect to the rejection of claim 26 under 35 U.S.C. 101 have been fully considered and are persuasive. The 35 U.S.C. 101 rejection of claim 26 has been withdrawn.
In response to Argument 3, see remarks, filed 05/01/2026, with respect to the § 103 rejection(s) of independent claims 1, 16, and 26 and dependent claims 6, 9, 13, 14, 21, 24, and 25 over Boddington in view of Hughes have been considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for independent claims 1, 16, and 26 and dependent claims 6, 9, 13, 14, 21, 24, and 25 under U.S.C. 103 in view of Boddington et al. (U.S. Patent Pub. No. 2022/0265233 A1, hereafter referred to as Boddington) in view of Mahfouz (U.S. Patent Pub. No. 2019/0133693 A1, hereafter referred to as Mahfouz).
Specifically, Boddington teaches an artificial intelligence intraoperative surgical guidance system in joint replacements and implant placement/alignment. Specifically, Boddington teaches capturing a series of x-ray or fluoroscopic images of a surgical site and a computing platform for processing the captured images and providing an output to an electronic display device. The computing platform may display intraoperative anatomical or implant positional information and provide implant alignment and correction guidance (Paragraph [0076]). Boddington further teaches a 3D Shape Modeling Module stored on the computing device for reconstruction and fitting of 3D models of anatomical shape to intraoperative 2D or 3D image data (Paragraph [0099]). Boddington further teaches obtaining an intraoperative radiographic image of an anteroposterior cup and the patient’s pelvis/hip (Paragraph [0174]). Additionally, Boddington teaches calculating surgical decision risks, such as a sub-optimal surgical outcome due to implant placement and providing intra-operative guidance to the surgeon via a visual display (Paragraph [0086]). The Examiner finds that Mahfouz is related to Boddington for providing real-time intraoperative surgical guidance for surgical procedures such as joint replacement surgeries. Specifically, Mahfouz teaches performing 3D to 2D registration to align the 3D anatomy with the image using landmark-based registration, where 3D landmarks on the 3D model are registered to corresponding 2D landmarks on the image and the location of the 3D landmarks after projection is minimized (Paragraph [0105]). Further, additional x-ray or fluoroscopic images may be captured after placing the trials and/or final implants to measure final implant placement, leg offset, and leg length (Paragraph [0105]). In addition, a kinematic simulation may be performed to evaluate the placement of the implant by taking the implant through a range of motion (Paragraph [0143]). The kinematic simulation may also determine impingement locations and estimate the resulting range of motion of the implant post implantation (Paragraph [0143]). The reason to combine is as follows: It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington by performing a 3D to 2D registration process by aligning the implant in a position and orientation relative to the 3D anatomical models and performing kinematic simulations using the joint/implant component 3D model taught by Mahfouz, resulting in an updated 3D model containing the joint and implant. One of ordinary skill in the art would have been motivated to combine these references because by updating the model to reflect an actual implanted pose of the implant and performing a kinematic simulation, the simulation software can suggest alternate sizing and positioning to allow the configuration that results in minimal offset and leg length discrepancy (i.e., satisfactory outcome) (Paragraph [0106]).
In response to Argument 4, see remarks, filed 05/01/2026, with respect to the § 103 rejection(s) of claims 2, 3, 7, 10, 17, and 18 over Boddington in view of Hughes, in further view of McKinnon have been considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made for Claims 2, 3, 7, 10, 17, and 18 in view of Boddington et al. (U.S. Patent Pub. No. 2022/0265233 A1, hereafter referred to as Boddington) in view of Mahfouz (U.S. Patent Pub. No. 2019/0133693 A1, hereafter referred to as Mahfouz) in further view of McKinnon et al. (US 20200275976 A1, hereafter referred to as McKinnon).
Boddington in view of Mahfouz teaches the system, computer-implemented method, and non-transitory computer readable medium of independent Claims 1, 16, and 26 (See response to Argument 3 above). McKinnon teaches a method for optimizing knee arthroplasty surgeries. Specifically, McKinnon teaches a surgical plan which can be viewed and modified preoperatively and intraoperatively (Paragraph [0100]). The surgical plan is based on a three-dimensional model of the joint and contains additional patient-specific information such as the mechanical and anatomical axes of the leg bones, the epicondylar axis, the femoral neck axis, the dimensions (e.g., length) of the femur and hip, the midline axis of the hip joint, the ASIS axis of the hip joint, and the location of anatomical landmarks such as the lesser trochanter landmarks, the distal landmark, and the center of rotation of the hip joint (Paragraph [0099]). Further, McKinnon teaches an anatomical modeling software for virtually simulating the positions and orientations of implants in relation to bony anatomy throughout a variety of activities a patient may experience post-surgery, or activities that pose a high risk for impingement and dislocation, such as crossing legs while seated, deep flexion while sitting, hyperextension while standing, etc. (Paragraph [0236]). The reason to combine is as follows: It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington in view of Mahfouz by developing a surgical plan to accurately plan, track, navigate, and simulate the placement of instruments and implants relative to the body of the patient that is taught by McKinnon, resulting in a intraoperative guidance system that generates and displays patient-specific kinematic and kinetic response values reflecting the actual implanted pose of the implant. One of ordinary skill in the art would have been motivated to make this combination because implementing the software of McKinnon can help better determine how changes in the size and pose of the implant components can impact the mechanics of the replacement knee and model the implant performance post-operatively (Paragraph [0235]).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 16, and 26 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The term “relevant portions” in claims 1, 16, and 26 is a relative term which renders the claim indefinite. The term “relevant portions” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 6-7, 9-10, 13-14, 16-18, 21, and 24-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 6-7, 9-10, 13-14, 16-18, 21, and 24-26 of copending Application No. 17/905,681 in view of Mahfouz et al. (U.S. Patent Pub. No. 20190133693 A1, hereafter referred to as Mahfouz).
Instant Application (17/905,680)
Reference (copending Application No. 17/905,681)
An intraoperative guidance system for total joint replacement of a joint of a patient by a surgeon,
the guidance system comprising: an X-ray imaging device for single-shot application of X-ray radiation to the joint and for detecting X-ray radiation to create a digital image of the joint and an implant component during a total joint replacement surgery;
and a computer system configured to: store a digital three-dimensional model of the joint;
receive the digital image of the joint and the implant component during the total joint replacement surgery;
perform registration between the digital image and the digital three- dimensional model to determine a placement of the implant component in the digital image in relation to the digital three- dimensional model,
wherein the registration comprises a three- dimensional to two-dimensional registration in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model,
projecting the digital three- dimensional model into a two-dimensional space,
and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks;
update the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component;
determine an intraoperative simulated performance metric by performing a kinematic analysis on the updated digital three-dimensional model,
comprising simulating movement of relevant portions of the digital three-dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion;
and provide an indication to the surgeon of the intraoperative simulated performance metric as an assessment of a current placement of the implant component.
An intraoperative guidance system for total joint replacement of a joint of a patient by a surgeon,
the guidance system comprising: an X-ray imaging device for application of X-ray radiation to the joint and for detecting X-ray radiation to create a two-dimensional digital image of the joint and an implant component;
and a computer system configured to: store an initial three-dimensional model of the joint and the implant component;
receive two or more two-dimensional digital images of the joint and the implant component captured from two or more respective directions by the X-ray imaging device;
create a digital three-dimensional model of the joint and the implant component based on the two or more two-dimensional digital images;
perform registration between the digital three-dimensional model and the initial three-dimensional model to determine a placement of the implant component in the digital three- dimensional model in relation to a placement of the implant component in the initial three- dimensional model;
determine an intraoperative simulated performance metric by simulating movement of the digital three-dimensional model based on the placement of the implant component in the two or more two-dimensional digital images;
and provide an indication to the surgeon of the intraoperative simulated performance metric as an assessment of a current placement of the implant component.
Copending application (No. 17/905,680) does not disclose wherein the registration comprises a three- dimensional to two-dimensional registration in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model, projecting the digital three- dimensional model into a two-dimensional space, and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks; update the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component and simulating movement of relevant portions of the digital three-dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion.
However, Mahfouz discloses wherein the registration comprises a three- dimensional to two-dimensional registration (Paragraphs [0105], [0044], Mahfouz teaches a 3D to 2D registration.) in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model (Paragraphs [0105], [0044], Mahfouz teaches landmark-based registration, where 3D anatomical landmarks on the 3D anatomy are registered to corresponding 2D landmarks on the image by adjusting the pose of the 3D bone.), projecting the digital three- dimensional model into a two-dimensional space (Paragraph [0013], [0105], Mahfouz teaches projecting the three-dimensional landmarks onto a two-dimensional image.), and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks (Paragraph [0105], Mahfouz teaches minimizing a distance between the selected 2D landmarks on the image and the location of the 3D landmarks after projection onto the 2D image.); update the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component (Paragraph [0106], Mahfouz teaches registering the position and orientation of the implant to the image by a 3D to 2D registration process through initialization by aligning the 3D implant in a default or planned position and orientation relative to the already registered 3D anatomical models. Once the implant component is registered, the orientation and position of the component may be calculated in the 3D coordinate system and reported to the operator on the screen. If both femoral and acetabular components have been placed and 3D models have been registered to an image containing both components, final component orientation and positioning can be computed.) and simulating movement of relevant portions of the digital three-dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion (Paragraphs [0143], [0106], Mahfouz teaches performing a kinematic simulation which may take the implant (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics. The kinematic simulation may be used to determine impingement locations and estimate the resulting range of motion of the implant post implantation.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply and/or modify the co-pending application (17/906,681) claims by performing a 3D to 2D registration between the captured x-ray image and the 3D anatomical model, updating the 3D model to reflect an actual implanted pose of the implant in the x-ray/fluoroscopy image, and performing kinematic simulations using the updated model that is taught by Mahfouz, to make the invention that ensures the implant is properly placed and aligned relative to the patient’s anatomy during surgery and provides information to the surgeon indicating the current placement would result in an unsatisfactory surgical result. Thus, one of ordinary skilled in the art would be motivated to combine the references since real-time intraoperative guidance may be achieved by tracking instrumentation/components in reference to patient anatomy to achieve the desired surgical result. For example, the 3D to 2D registration enables the measurement of final implant placement, leg offset, and leg length (Mahfouz, Paragraph [0105]). In addition, the kinematic simulation may determine impingement locations and estimate the resulting range of motion of the implant post implantation as well as refine the implant placement until reaching a satisfactory result (Mahfouz, Paragraph [0143]).
The computer-implemented method and non-transitory computer-readable storage medium claims of Claim 16 and 26 have similar limitations to the system of Claim 1 and are rejected under the same rationale.
Dependent claims 2-3, 6-7, 9-10, 13-14, 17-18, 21, and 24-25 of the current application recite the same limitations in different language to claims 2-3, 6-7, 9-10, 13-14, 17-18, 21, and 24-25 of the co-pending application. Accordingly, although the conflicting claims of the current application and the co-pending application are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 6, 9, 13, 14, 16, 21, 24, 25, and 26 are rejected under 35 U.S.C. 103(a) as being unpatentable over Boddington et al. (U.S. Patent Pub. No. 2022/0265233 A1, hereafter referred to as Boddington) in view of Mahfouz (U.S. Patent Pub No. 2019/0133693 A1, hereafter referred to as Mahfouz).
Regarding Claim 1, Boddington teaches an intraoperative guidance system for total joint replacement of a joint of a patient by a surgeon (Paragraph [0004], Boddington teaches an intraoperative surgical guidance system in joint replacements and for providing recommendations to support the decision-making process of a surgeon to predict optimized implant and subject outcomes.), the guidance system comprising: an X-ray imaging device for single-shot application of X-ray radiation to the joint and for detecting X-ray radiation to create a digital image of the joint and an implant component during a total joint replacement surgery (Paragraphs [0063], [0075], [0187], Fig. 1A, Fig. 26B, Boddington teaches an imaging system (110), which receives subject image data such as radiographic images of the subject’s anatomy. Fig. 26B shows an intraoperative image of the anteroposterior pelvis along with an implant cup and stem.);
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and a computer system (Paragraphs [0080], [0083], Fig. 2A, Boddington teaches a computing platform. The computing platform (100) includes a plurality of software modules (103).) configured to: store a digital three-dimensional model of the joint (Paragraph [0099], Fig. 4A, Fig. 16, Boddington teaches 3D Shape Modeling Module (10) for computing three-dimensional anatomical shape information. Fig. 16 below, shows the output of the Shape Modeling Module.);
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receive the digital image of the joint and the implant component during the total joint replacement surgery (Fig. 27A, Fig. 19A, Paragraphs [0119-121], [0188], [0157-159], Boddington teaches preparing and positioning the patient for the surgery in a standard manner as indicated for the specific procedure, for example, a joint replacement surgery. A preoperative image is imported and a grid template is superimposed over the patient’s anatomical image. The grid templates contain may contain lines, geometrical patterns, numbers, letters, complex patterns of multiple lines and geometries corresponding to surgical variables and can be pre-designed or constructed intraoperatively. Next, the procedure specific information is extracted from the pre-operative image/data and mapped into the live intraoperative images. Fig. 27A, shown below, depicts use of a grid template in a hip total arthroplasty (THA). For example, if teardrops, symphysis pubis, ipsilateral teardrop, implant (cup) and stem (implant) and femoral head implant are detected, a functional pelvis grid/template is registered to the image.);
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and provide an indication to the surgeon of the intraoperative simulated performance metric as an assessment of a current placement of the implant component (Paragraph [0148], Boddington teaches providing surgical guidance via outputs such as implant selection recommendations, implant placement, performance predictions, probability of good outcomes, and failure risk scores. The surgeon is provided with a Failure Risk Score as a confidence percentage recommendation of a suboptimal or optimal performance metric. The output is presented to the user in the form of intelligent predictors and scores to support decisions encountered in a real-time surgical event.).
Boddington does not explicitly disclose perform(ing) registration between the digital image and the digital three- dimensional model to determine a placement of the implant component in the digital image in relation to the digital three- dimensional model, wherein the registration comprises a three- dimensional to two-dimensional registration in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model, projecting the digital three- dimensional model into a two-dimensional space, and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks; update the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component; determine an intraoperative simulated performance metric by performing a kinematic analysis on the updated digital three-dimensional model, comprising simulating movement of relevant portions of the digital three-dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion;
Mahfouz is in the same field of art of providing intraoperative surgical guidance during surgeries, such as total joint replacement surgeries. Further, Mahfouz teaches perform(ing) registration between the digital image and the digital three- dimensional model to determine a placement of the implant component in the digital image in relation to the digital three- dimensional model (Paragraphs [0044], [0105], [0163], [0194], Mahfouz teaches registration of a three-dimensional model to a two-dimensional x-ray or fluoroscopy image. Additional X-ray or fluoroscopic images may be taken upon placement of the trials and/or final implants to measure the final implant placement via another registration step of anatomy to images and components to images. Multiple objects may be registered to the same image.), wherein the registration comprises a three- dimensional to two-dimensional registration (Paragraphs [0105], [0044], Mahfouz teaches a 3D to 2D registration process.) in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model (Paragraphs [0105], [0044], Mahfouz teaches landmark-based registration, where 3D anatomical landmarks on the 3D anatomy are registered to corresponding 2D landmarks on the image by adjusting the pose of the 3D bone.), projecting the digital three- dimensional model into a two-dimensional space (Paragraph [0013], [0105], Mahfouz teaches projecting the three-dimensional landmarks onto a two-dimensional image.), and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks (Paragraph [0105], Mahfouz teaches minimizing a distance between the selected 2D landmarks on the image and the location of the 3D landmarks after projection onto the 2D image.); update the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component (Paragraphs [0106], [0014], Fig. 47, Mahfouz teaches registering the position and orientation of the implant to the image by a 3D to 2D registration process through initialization by aligning the 3D implant in a default or planned position and orientation relative to the already registered 3D anatomical models. During or after a final or trial component or components have been placed, radiographic images can be taken, The images may be used to detect trial orientation and position relative to anatomy via 3D-to-2D registration of the components and anatomy or landmarks to the image plane. Once the implant component is registered, the orientation and position of the component may be calculated in the 3D coordinate system and reported to the operator on the screen.);
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determine an intraoperative simulated performance metric by performing a kinematic analysis on the updated digital three-dimensional model (Paragraphs [0143], [0067-68], Fig. 48, Mahfouz teaches performing a kinematic simulation which may take the implant component (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics. In addition, the registered 3D model may be used to measure leg length.), comprising simulating movement of relevant portions of the digital three-dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion (Paragraphs [0143], [0106], Mahfouz teaches performing a kinematic simulation which may take the implant (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics. The kinematic simulation may be used to determine impingement locations and estimate the resulting range of motion of the implant post implantation. The Examiner interprets all portions of the model to be “relevant” portions of the model since the claim is silent to the definition of “relevant.”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington by performing a 3D to 2D registration to generate an updated and realistic 3D anatomical model including the joint and implant component in their actual positions that is taught by Mahfouz, to make the invention that performs a simulated kinematic analysis using the registered 3D joint/implant model to determine performance metrics for the actual implanted location of the implant during the joint replacement surgery; thus, one of ordinary skilled in the art would be motivated to combine the references since the 3D model and imaging may be used in intraoperative registration to decrease surgical time and reduce additional costs compared to 3D models requiring off-site reconstruction (Mahfouz, Paragraph [0002]). Additionally, once the 3D-to-2D image registration has been completed, orientation metrics such as combined anteversion and abduction angles can be determined based on the relative orientation difference of the 3D to 2D models (Mahfouz, Paragraph [0067]) to enable placement of the components according to the defined surgical target (Mahfouz, Paragraph [0107]).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
In regards to Claim 6, Boddington in view of Mahfouz discloses the system of claim 1, wherein the intraoperative simulated performance metric is an indication of a risk stratification (Paragraphs [0086], [0106], [0115], Boddington teaches calculating intra-operative surgical decision risks in the form of a Failure Risk Score. The Failure Risk Score is provided to the surgeon to support decisions that lead to optimal surgical outcomes and avoid suboptimal surgical outcomes.).
In regards to Claim 9, Boddington in view of Mahfouz discloses the system of claim 1, wherein the computer system comprises: at least one processor (Paragraph [0082], Fig. 2A, reference characters 100 and 101, Boddington teaches a computing platform (100) having at least one processor (101).);
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and at least one memory storing program code accessible by the at least one processor (Paragraphs [0081-82], Fig. 2A, reference character 102, Boddington teaches a memory device (102) having stored thereon computer executable instructions that when executed by the processor of a computer platform to perform the steps.), and configured to cause the at least one processor to: store the digital three-dimensional model of the joint (Paragraph [0099], Fig. 4A, Fig. 16, Boddington teaches 3D Shape Modeling Module (10) for computing three-dimensional anatomical shape information. Fig. 16 shows output of the Shape Modeling Module.); receive the digital image of the joint and the implant component during the total joint replacement surgery (Fig. 27A, Paragraphs [0119-121], [0188], Boddington teaches preparing and positioning the patient for the surgery in a standard manner as indicated for the specific procedure, for example, a joint replacement surgery. A preoperative image is imported and a grid template is superimposed over the patient’s anatomical image. The grid templates contain may contain lines, geometrical patterns, numbers, letters, or a complex pattern of multiple lines and geometries corresponding to surgical variables and can be pre-designed or constructed intraoperatively. Next, the procedure specific information is extracted from the pre-operative image/data and mapped into the live intraoperative images. Fig. 27A, shown below, depicts use of a grid template in a hip total arthroplasty (THA). For example, if teardrops, symphysis pubis, ipsilateral teardrop, implant (cup) and stem (implant) and femoral head implant are detected, a functional pelvis grid/template is registered to the image.); perform the registration between the digital image and the digital three-dimensional model to determine the placement of the implant component in the digital image in relation to the digital three-dimensional model (Paragraphs [0044], [0105], [0163], [0194], Mahfouz teaches registration of a three-dimensional model to a two-dimensional x-ray or fluoroscopy image. Additional X-ray or fluoroscopic images may be taken upon placement of the trials and/or final implants to measure the final implant placement via another registration step of anatomy to images and components to images. Multiple objects may be registered to the same image.); determine the intraoperative simulated performance metric by simulating movement of the digital three-dimensional model based on the placement of the implant component in the digital image (Paragraphs [0143], Mahfouz teaches performing a kinematic simulation which may take the implant component (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics.) and provide the indication to the surgeon (Paragraph [0083], Boddington teaches providing the user with a Failure Risk Score with the output to the user as a confidence percentage recommendation of a suboptimal or optimal performance metric associated with an implant or anatomical alignment.).
In regards to Claim 13, Boddington in view of Mahfouz teaches the system of claim 1, wherein the system comprises a display (Paragraph [0076], Boddington teaches an electronic display device.), and wherein the intraoperative simulated performance metric is provided as a visual output using the display (Paragraphs [0007], [0073], [0076], Boddington teaches providing an intra-operative visual display to the user showing intra-operative surgical decision risks or a probability of a successful procedural outcome.).
In regards to Claim 14, Boddington in view of Mahfouz teaches the system of claim 1, wherein determining the placement of the implant component in the digital image comprises identifying one or more edges of the implant component in the digital image (Paragraph [0185], Fig. 23C, Boddington teaches registering the implant cup grid to the anatomical structures and fitting an ellipse to the implant cup. The ellipse is the outline of the edge of the cup. The Examiner interprets that fitting an ellipse to the edge of the implant cup is identifying an edge of the implant cup in the image since the claim is silent to how the implant component edge/ edges are detected. Under Broadest Reasonable Interpretation, the Examiner interprets the limitation “one or more edges” to mean only one edge is required to meet the claim limitation.).
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In regards to Claim 16, Boddington teaches a computer-implemented method for assisting a surgeon in total joint replacement of a joint of a patient (Paragraphs [0004-5], [0007], Boddington teaches a method for providing intraoperative automated intelligence guided surgical guidance in joint replacements, which is carried out by a computing platform.), the method comprising: storing a digital three-dimensional model of the joint (Paragraph [0099], Fig. 4A, Fig. 16, Boddington teaches 3D Shape Modeling Module (10) for computing three-dimensional anatomical shape information. Fig. 16 shows output of the Shape Modeling Module.); receiving a digital image of the joint and an implant component during the total joint replacement surgery (Fig. 27A, Paragraphs [0119-121], [0188], Boddington teaches preparing and positioning the patient for the surgery in a standard manner as indicated for the specific procedure, for example, a joint replacement surgery. A preoperative image is imported and a grid template is superimposed over the patient’s anatomical image. The grid templates contain may contain lines, geometrical patterns, numbers, letters, or a complex pattern of multiple lines and geometries corresponding to surgical variables and can be pre-designed or constructed intraoperatively. Next, the procedure specific information is extracted from the pre-operative image/data and mapped into the live intraoperative images. Fig. 27A, shown below, depicts use of a grid template in a hip total arthroplasty (THA). For example, if teardrops, symphysis pubis, ipsilateral teardrop, implant (cup) and stem (implant) and femoral head implant are detected, a functional pelvis grid/template is registered to the image.); and providing an indication to the surgeon of the intraoperative simulated performance metric as an assessment of a current placement of the implant component (Paragraph [0148], Boddington teaches providing outputs related to surgical guidance such as implant selection recommendations, implant placement, performance predictions, probability of good outcomes, and failure risk scores. The user is provided with a Failure Risk Score as a confidence percentage recommendation of a suboptimal or optimal performance metric. The output is presented to the user in the form of intelligent predictors and scores to support decisions encountered in a real-time event.).
Boddington does not explicitly disclose performing registration between the digital image and the digital three- dimensional model to determine a placement of the implant component in the digital image in relation to the digital three-dimensional model, wherein the registration comprises a three-dimensional to two-dimensional registration in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model, projecting the digital three-dimensional model into a two-dimensional space, and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks; updating the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component; determining an intraoperative simulated performance metric by performing a kinematic analysis on the updated digital three-dimensional model, comprising simulating movement of relevant portions of the digital three- dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion.
Mahfouz is in the same field of art of providing intraoperative surgical guidance during surgeries, such as total joint replacement surgeries. Further, Mahfouz teaches performing registration between the digital image and the digital three- dimensional model to determine a placement of the implant component in the digital image in relation to the digital three-dimensional model (Paragraphs [0044], [0105], [0163], [0194], Mahfouz teaches registration of a three-dimensional model to a two-dimensional x-ray or fluoroscopy image. Additional X-ray or fluoroscopic images may be taken upon placement of the trials and/or final implants to measure the final implant placement via another registration step of anatomy to images and components to images. Multiple objects may be registered to the same image.), wherein the registration comprises a three-dimensional to two-dimensional registration (Paragraphs [0105], [0044], Mahfouz teaches a 3D to 2D registration process.) in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model (Paragraphs [0105], [0044], Mahfouz teaches landmark-based registration, where 3D anatomical landmarks on the 3D anatomy are registered to corresponding 2D landmarks on the image by adjusting the pose of the 3D bone.), projecting the digital three-dimensional model into a two-dimensional space (Paragraph [0013], [0105], Mahfouz teaches projecting the three-dimensional landmarks onto a two-dimensional image.), and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks (Paragraph [0105], Mahfouz teaches minimizing a distance between the selected 2D landmarks on the image and the location of the 3D landmarks after projection onto the 2D image.); updating the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component (Paragraph [0106], Mahfouz teaches registering the position and orientation of the implant to the image by a 3D to 2D registration process through initialization by aligning the 3D implant in a default or planned position and orientation relative to the already registered 3D anatomical models. Once the implant component is registered, the orientation and position of the component may be calculated in the 3D coordinate system and reported to the operator on the screen.); determining an intraoperative simulated performance metric by performing a kinematic analysis on the updated digital three-dimensional model (Paragraphs [0143], Mahfouz teaches performing a kinematic simulation which may take the implant component (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics.), comprising simulating movement of relevant portions of the digital three- dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion (Paragraphs [0143], [0106], Mahfouz teaches performing a kinematic simulation which may take the implant (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics. The kinematic simulation may be used to determine impingement locations and estimate the resulting range of motion of the implant post implantation. The Examiner interprets “relevant portions” of the 3D model to be any portion of the 3D model since the claim is silent to the definition of “relevant portions.”).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington by performing a 3D to 2D registration to generate an updated and realistic 3D anatomical model including the joint and implant component in their actual positions that is taught by Mahfouz, to make the invention that performs a simulated kinematic analysis using the registered 3D joint/implant model to determine performance metrics for the actual implanted location of the implant during the joint replacement surgery; thus, one of ordinary skilled in the art would be motivated to combine the references since the 3D model and imaging may be used in intraoperative registration to decrease surgical time and reduce additional costs compared to 3D models requiring off-site reconstruction (Mahfouz, Paragraph [0002]). Additionally, once the 3D-to-2D image registration has been completed, orientation metrics such as combined anteversion and abduction angles can be determined based on the relative orientation difference of the 3D to 2D models (Mahfouz, Paragraph [0067]) to enable placement of the components according to the defined surgical target (Mahfouz, Paragraph [0107]).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
In regards to Claim 21, Boddington in view of Mahfouz discloses the method of claim 16, wherein the intraoperative simulated performance metric is an indication of a risk stratification (Paragraph [0143], Mahfouz teaches the kinematic simulation may be used to determine impingement locations and estimate the resulting range of motion of the implant post implantation. In cases where the kinematic simulation results in unsatisfactory data (e.g., unsatisfactory range of motion, unsatisfactory mimicking of natural kinematics, etc.), another implant location can be utilized until the implant placement achieves a satisfactory result.).
In regards to Claim 24, Boddington in view of Mahfouz discloses the method of claim 16, wherein the intraoperative simulated performance metric is provided as a visual output on a display (Paragraphs [0007], [0073], [0076], Boddington teaches providing an intra-operative visual display to the user showing surgical guidance such as intra-operative surgical decision risks or a probability of a successful procedural outcome.).
In regards to Claim 25, Boddington in view of Mahfouz discloses the method of claim 16, wherein determining the placement of the implant component in the digital image comprises identifying one or more edges of the implant component in the digital image (Paragraph [0185], Fig. 23C, Boddington teaches registering the implant cup grid to the anatomical structures and fitting an ellipse to the implant cup. The ellipse is the outline of the edge of the cup. The Examiner interprets that fitting an ellipse to the edge of the implant cup is identifying an edge of the implant cup in the image since the claim is silent to how the implant component edges are detected. Under Broadest Reasonable Interpretation, the limitation “one or more edges” requires only one edge to be identified to meet the claim limitation.).
In regards to Claim 26, Boddington in view of Mahfouz discloses a non-transitory computer-readable storage medium storing instructions that, when executed by a computing device, cause the computing device to perform one or more operations comprising (Paragraph [0009], Boddington teaches a non-transitory computer-readable storage medium encoded with computer-readable instructions which form a software module and a processor to process the instructions.): storing a digital three-dimensional model of a joint (Paragraph [0099], Fig. 16, Boddington teaches 3D Shape Modeling Module for computing three-dimensional anatomical shape information. Fig. 16 shows output of the Shape Modeling Module. The Examiner interprets “one or more operations” to mean only one of the limitations is required to meet the claim limitation. For example, a non-transitory computer-readable medium performing the one operation of storing a digital 3D model of the joint would be sufficient to reject the claim. Additional citations are provided below for completeness.); receiving a digital image of the joint and an implant component during a total joint replacement surgery (Fig. 27A, Paragraphs [0119-121], [0188], Boddington teaches preparing and positioning the patient for the surgery in a standard manner as indicated for the specific procedure, for example, a joint replacement surgery. A preoperative image is imported and a grid template is superimposed over the patient’s anatomical image. The grid templates contain may contain lines, geometrical patterns, numbers, letters, or a complex pattern of multiple lines and geometries corresponding to surgical variables and can be pre-designed or constructed intraoperatively. Next, the procedure specific information is extracted from the pre-operative image/data and mapped into the live intraoperative images. Fig. 27A, shown below, depicts use of a grid template in a hip total arthroplasty (THA). For example, if teardrops, symphysis pubis, ipsilateral teardrop, implant (cup) and stem (implant) and femoral head implant are detected, a functional pelvis grid/template is registered to the image.); and providing an indication to the surgeon of the intraoperative simulated performance metric as an assessment of a current placement of the implant component (Paragraph [0148], Boddington teaches outputs related to surgical guidance such as implant selection recommendations, implant placement, performance predictions, probability of good outcomes, and failure risk scores. The user is provided with a Failure Risk Score as a confidence percentage recommendation of a suboptimal or optimal performance metric. The output is presented to the user in the form of intelligent predictors and scores to support decisions encountered in a real-time event.).
Boddington does not explicitly disclose performing registration between the digital image and the digital three-dimensional model to determine a placement of the implant component in the digital image in relation to the digital three-dimensional model, wherein the registration comprises a three-dimensional to two-dimensional registration in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model, projecting the digital three-dimensional model into a two- dimensional space, and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks; updating the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component; determining an intraoperative simulated performance metric by performing a kinematic analysis on the updated digital three-dimensional model, comprising simulating movement of relevant portions of the digital three-dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion.
Mahfouz is in the same field of art of providing intraoperative surgical guidance during surgeries, such as total joint replacement surgeries. Further, Mahfouz discloses performing registration between the digital image and the digital three-dimensional model to determine a placement of the implant component in the digital image in relation to the digital three-dimensional model (Paragraphs [0044], [0105], [0163], [0194], Mahfouz teaches registration of a three-dimensional model to a two-dimensional x-ray or fluoroscopy image. Additional X-ray or fluoroscopic images may be taken upon placement of the trials and/or final implants to measure the final implant placement via another registration step of anatomy to images and components to images. Multiple objects may be registered to the same image.), wherein the registration comprises a three-dimensional to two-dimensional registration (Paragraphs [0105], [0044], Mahfouz teaches a 3D to 2D registration process.) in which one or more three-dimensional model landmarks of the digital three-dimensional model are registered to one or more corresponding digital image landmarks of the digital image by iteratively adjusting a pose of the digital three-dimensional model (Paragraphs [0105], [0044], Mahfouz teaches landmark-based registration, where 3D anatomical landmarks on the 3D anatomy are registered to corresponding 2D landmarks on the image by adjusting the pose of the 3D bone.), projecting the digital three-dimensional model into a two- dimensional space (Paragraph [0013], [0105], Mahfouz teaches projecting the three-dimensional landmarks onto a two-dimensional image.), and minimizing a distance between the one or more three-dimensional model landmarks and the one or more corresponding digital image landmarks (Paragraph [0105], Mahfouz teaches minimizing a distance between the selected 2D landmarks on the image and the location of the 3D landmarks after projection onto the 2D image.); updating the digital three-dimensional model based on the placement of the implant component to reflect an actual implanted pose of the implant component (Paragraph [0106], Mahfouz teaches registering the position and orientation of the implant to the image by a 3D to 2D registration process through initialization by aligning the 3D implant in a default or planned position and orientation relative to the already registered 3D anatomical models. Once the implant component is registered, the orientation and position of the component may be calculated in the 3D coordinate system and reported to the operator on the screen.); determining an intraoperative simulated performance metric by performing a kinematic analysis on the updated digital three-dimensional model (Paragraphs [0143], Mahfouz teaches performing a kinematic simulation which may take the implant component (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics.), comprising simulating movement of relevant portions of the digital three-dimensional model based on the placement of the implant component in the digital image to determine a postoperative range of motion (Paragraphs [0143], [0106], Mahfouz teaches performing a kinematic simulation which may take the implant (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics. The kinematic simulation may be used to determine impingement locations and estimate the resulting range of motion of the implant post implantation.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington by performing a 3D to 2D registration to generate an updated and realistic 3D anatomical model including the joint and implant component in their actual positions that is taught by Mahfouz, to make the invention that performs a simulated kinematic analysis using the registered 3D joint/implant model to determine performance metrics for the actual implanted location of the implant during the joint replacement surgery; thus, one of ordinary skilled in the art would be motivated to combine the references since the 3D model and imaging may be used in intraoperative registration to decrease surgical time and reduce additional costs compared to 3D models requiring off-site reconstruction (Mahfouz, Paragraph [0002]). Additionally, once the 3D-to-2D image registration has been completed, orientation metrics such as combined anteversion and abduction angles can be determined based on the relative orientation difference of the 3D to 2D models (Mahfouz, Paragraph [0067]) to enable placement of the components according to the defined surgical target (Mahfouz, Paragraph [0107]).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Claims 2-3, 7, 10, and 17-18 are rejected under 35 U.S.C. 103(a) as being unpatentable over Boddington et al. (U.S. Patent Pub. No. 2022/0265233 A1, hereafter referred to as Boddington) in view of Mahfouz (U.S. Patent Pub No. 2019/0133693 A1, hereafter referred to as Mahfouz) in further view of McKinnon et al. (U.S. Patent Pub. No. 2020/0275976 A1, hereafter referred to as McKinnon).
Regarding Claim 2, Boddington in view of Mahfouz discloses the system of claim 1.
Boddington in view of Mahfouz does not explicitly disclose wherein the computer system is configured to determine a preoperative simulated performance metric by simulating movement of the digital three-dimensional model according to a surgical plan, the surgical plan comprising a planned placement of the implant component in the digital three-dimensional model.
McKinnon is in the same field of art of optimizing arthroplasty surgical procedures by determining patient-specific kinematic and kinetic response values to determine the optimal orientation and position of a joint replacement implant. Further, McKinnon teaches wherein the computer system is configured to determine a preoperative simulated performance metric by simulating movement of the digital three-dimensional model according to a surgical plan (Paragraphs [0234-237], Figs. 12A-C, McKinnon teaches an anatomical modeling software for developing a pre-operative plan to guide surgery. In the context of knee surgery, the software can determine how changes in the position and orientation of the implant components can affect the mechanics of the replacement knee. For example, the software can incorporate these variables throughout a range of motion and exemplary forces for a given patient activity to model the implant performance. Figs. 12A-C show outputs of the software to visually depict the results. Figs. 12A and 12B show hip range of motion (ROM) plots. Fig. 12 C shows a graph that represent a recommendation for a desirable or “safe” range of positions for seating a hip implant in the acetabulum.), the surgical plan comprising a planned placement of the implant component in the digital three-dimensional model (Paragraphs [0099-100], McKinnon teaches a surgical plan providing recommended implant position and orientation based on the three-dimensional model of the joint. The surgical plan can display the planned resection to the joint and superimpose the planned implants onto the joint.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington in view of Mahfouz by determining a preoperative performance measure such as hip range of motion (ROM) based on the planned placement of the implant in the surgical plan that is taught by McKinnon to make the invention that plans the orientation and position of the joint replacement based on the surgical plan prior to commencing surgery; thus, one of ordinary skill in the art would have been motivated to combine the references to improve and adjust the surgical plan intraoperatively as additional information is gathered about the patient’s joint (McKinnon, Paragraph [0003]).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
Regarding Claim 3, Boddington in view of Mahfouz in further view of McKinnon teaches wherein the indication comprises a comparison between the intraoperative simulated performance metric and the preoperative simulated performance metric (Paragraphs [0162-0163], [0173], Boddington teaches obtaining a pre-operative anteroposterior radiographic reference image (anteroposterior hip view or anteroposterior pelvis view) and defining at least one reference image metric. The metrics can include leg length and offset, ipsilateral, leg length and offset, contralateral, pelvic tilt, pelvic rotation, femoral abduction (ipsil & contra), femoral rotation (ipsil & contra) and femoral head center of rotation. During surgery, an intra-operative anteroposterior radiographic image (anteroposterior hip view or anteroposterior pelvis view) is obtained. Next, the reference image is compared to the intraoperative image. The differences in the images look at: pelvic tilt, pelvic rotation, and contralateral femoral rotation/abduction in an alternative embodiment, taken from the ipsilateral side: anteroposterior Hip (detected when limited points available).).
Regarding Claim 7, Boddington in view of Mahfouz teaches the system of claim 6.
Boddington in view of Mahfouz does not explicitly disclose wherein the risk stratification is indicative of a risk associated with multiple predicted postoperative movements by the patient.
McKinnon is in the same field of art of optimizing arthroplasty surgical procedures by determining patient-specific kinematic and kinetic response values to determine the optimal orientation and position of a joint replacement implant. Further, McKinnon teaches wherein the risk stratification is indicative of a risk associated with multiple predicted postoperative movements by the patient (Paragraph [0236], Figs. 12A-C, McKinnon teaches simulating the positions and orientations of implants in relation to bony anatomy throughout a variety of activities that a patient may experience post-surgery such as activities that pose a high risk for impingement and dislocation such as crossing legs while seated, deep flexion while sitting, hyperextension while standing, etc. Fig. 12C shows a 2D graph that demonstrates a recommendation for a “safe” range of positions for seating a hip implant in the acetabulum. For each possible implant position, the software tests whether a position creates a failure of the anatomy or implant under normal functional activities.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington in view of Mahfouz by virtually simulating the positions and orientations of the implants in relation to bony anatomy throughout a variety of post-surgery exercises/activities such as crossing legs while seated, deep flexion while sitting, and hyperextension while standing, and identifying any impinged range of motion where abnormal and wearing contact exists between the joint and the implant as well as identifying a safe range of positions for the hip implant in the acetabulum that is taught by McKinnon, to make the invention that visually depicts the results of the hip modeling simulation for a variety of post-operative movements to determine for each implant position, whether the position creates failure of the anatomy or implant under normal functional activities; thus, one of ordinary skilled in the art would be motivated to combine the references to better determine how changes in the size and pose of the implant components can affect the mechanics of the replacement joint and predict the optimal implant positions and orientations for each patient (McKinnon, Paragraph [0235]).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
In regards to Claim 10, Boddington in view of Mahfouz discloses the system of claim 1, wherein the computer system comprises: a first computing device (Paragraph [0075], Boddington teaches an intraoperative surgical guidance system having a computing platform.) comprising: at least one first processor (Paragraph [0081], Boddington teaches the computer platform includes at least one processor.); and at least one first memory storing program code accessible by the at least one first processor (Paragraph [0081], Boddington teaches the computing platform having a memory.), and configured to cause the at least one first processor to: store the digital three-dimensional model of the joint (Paragraph [0099], Fig. 4A, Fig. 16, Boddington teaches 3D Shape Modeling Module (10) for computing three-dimensional anatomical shape information. Fig. 16 shows output of the Shape Modeling Module.); receive the digital image of the joint and the implant component during the total joint replacement surgery (Fig. 27A, Paragraphs [0119-121], [0188], Boddington teaches preparing and positioning the patient for the surgery in a standard manner as indicated for the specific procedure, for example, a joint replacement surgery. A preoperative image is imported and a grid template is superimposed over the patient’s anatomical image. The grid templates contain may contain lines, geometrical patterns, numbers, letters, or a complex pattern of multiple lines and geometries corresponding to surgical variables and can be pre-designed or constructed intraoperatively. Next, the procedure specific information is extracted from the pre-operative image/data and mapped into the live intraoperative images. Fig. 27A, shown below, depicts use of a grid template in a hip total arthroplasty (THA). For example, if teardrops, symphysis pubis, ipsilateral teardrop, implant (cup) and stem (implant) and femoral head implant are detected, a functional pelvis grid/template is registered to the image.) perform(ing) registration between the digital image and the digital three- dimensional model to determine the placement of the implant component in the digital image in relation to the digital three-dimensional model (Paragraphs [0044], [0105], [0163], [0194], Mahfouz teaches registration of a three-dimensional model to a two-dimensional x-ray or fluoroscopy image. Additional X-ray or fluoroscopic images may be taken upon placement of the trials and/or final implants to measure the final implant placement via another registration step of anatomy to images and components to images. Multiple objects may be registered to the same image.); determin(Paragraphs [0143], [0106], Mahfouz teaches performing a kinematic simulation which may take the implant (based on the placement of the implant chosen) through a range of motion using estimated or measured joint kinematics. The kinematic simulation may be used to determine impingement locations and estimate the resulting range of motion of the implant post implantation.).
Boddington in view of Mahfouz does not explicitly disclose and a second computing device comprising: at least one second processor; and at least one second memory storing program code accessible by the at least one second processor, and configured to cause the at least one second processor to: provide the indication to the surgeon.
McKinnon is in the same field of art of optimizing arthroplasty surgical procedures by determining patient-specific kinematic and kinetic response values to determine the optimal orientation and position of a joint replacement implant. Further, McKinnon teaches a second computing device (Paragraph [0091], McKinnon teaches a Surgical Computer which provides control instructions to various components of the Computer Assisted Surgical System (CASS).) comprising: at least one second processor (Paragraph [0091], McKinnon teaches the Surgical Computer may be a parallel computing platform that uses multiple central processing units (CPUs) or graphics processing units (GPUs) to perform processing.); and at least one second memory storing program code accessible by the at least one second processor (Paragraph [0303], Fig. 20, McKinnon teaches the Surgical Computer having a device memory.), and configured to cause the at least one second processor to: provide the indication to the surgeon (Paragraph [0132], McKinnon teaches the Surgical Computer provides the Display with any visualization that is needed by the Surgeon during surgery. For example, the display is an interactive interface that can dynamically update and display how changes in the surgical plan would impact the procedure and the final position and orientation of implants installed on bone.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington in view of Mahfouz by adding a second computing device into the intraoperative surgical guidance system comprising at least one processor and at least one memory for providing the indication to the surgeon during surgery, that is taught by McKinnon to make the invention that iteratively updates and displays how the current position and orientation of an implant impacts the joint’s expected post-operative performance; thus, one of ordinary skill in the art would have been motivated to combine the references to accurately model anatomical response and guide the surgical plan to improve the existing approach (McKinnon, Paragraph [0206]).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
In regards to Claim 17, Boddington in view of Mahfouz discloses the method of claim 16.
Boddington in view of Mahfouz does not explicitly disclose determining a preoperative simulated performance metric by simulating movement of the digital three-dimensional model according to a surgical plan, the surgical plan comprising a planned placement of the implant component in the digital three-dimensional model.
McKinnon is in the same field of art of optimizing arthroplasty surgical procedures by determining patient-specific kinematic and kinetic response values to determine the optimal orientation and position of a joint replacement implant. Further, McKinnon discloses determining a preoperative simulated performance metric by simulating movement of the digital three-dimensional model according to a surgical plan (Paragraphs [0234-237], Figs. 12A-C, McKinnon teaches an anatomical modeling software for developing a pre-operative plan to guide surgery. In the context of hip surgery, if the software has knowledge of the relationship between the spine and pelvis throughout a variety of activities, the software can better predict an optimal implant position. In the context of knee surgery, the software can determine how changes in the position and orientation of the implant components can affect the mechanics of the replacement knee. For example, the software can incorporate these variables throughout a range of motion and exemplary forces for a given patient activity to model the implant performance. Figs. 12A-C show outputs of the software to visually depict the results. Figs. 12A and 12B show hip range of motion (ROM) plots. Fig. 12 C shows graphs that represent a recommendation for a desirable or “safe” range of positions for seating a hip implant in the acetabulum.), the surgical plan comprising a planned placement of the implant component in the digital three-dimensional model (Paragraphs [0099-100], McKinnon teaches a surgical plan providing recommended implant position and orientation based on the three-dimensional model of the joint. The surgical plan can display the planned resection to the joint and superimpose the planned implants onto the joint.).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Boddington in view of Mahfouz by using anatomical modeling software to develop a pre-operative surgical plan by performing a range-of-motion (ROM) “exam” and generating an ROM plot to identify any impinged ROM, that is taught by McKinnon, to make the invention that simulates movement of the joint in a variety of positions to determine an un-impinged ROM for safe positioning of the implant; thus, one of ordinary skilled in the art would be motivated to combine the references to better predict the optimal implant positions and orientations by incorporating the relationship between the complex joint anatomy throughout the range of motion and exemplary forces for a given patient activity/movement (McKinnon, Paragraph [0235]).
Thus, the claimed subject matter would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention.
In regards to Claim 18, Boddington in view of Mahfouz in further view of McKinnon discloses the method of claim 17, wherein the indication comprises a comparison between the intraoperative simulated performance metric and the preoperative simulated performance metric (Paragraphs [0162-0163], [0173], Boddington teaches obtaining a pre-operative anteroposterior radiographic reference image (anteroposterior hip view or anteroposterior pelvis view) and defining at least one reference image metric. The metrics can include leg length and offset, ipsilateral, leg length and offset, contralateral, pelvic tilt, pelvic rotation, femoral abduction (ipsil & contra), femoral rotation (ipsil & contra) and femoral head center of rotation. During surgery, an intra-operative anteroposterior radiographic image (anteroposterior hip view or anteroposterior pelvis view) is obtained. Next, the reference image is compared to the intraoperative image. The differences in the images look at: pelvic tilt, pelvic rotation, and contralateral femoral rotation/abduction in an alternative embodiment, taken from the ipsilateral side: anteroposterior Hip (detected when limited points available).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tao (U.S. Patent No. 11,257,241) teaches a system and method for helping to place or position an implant component, such as an acetabular cup or a femoral component, intraoperatively.
Feng et al. (U.S. Patent Pub. No. 2013/0177230) teaches determining the pose of an implant component from an x-ray image by aligning a 3D model of the implant with a sequence of x-ray images.
Mahfouz et al. (NPL “A Robust Method foe Registration of Three-Dimensional Knee Implant Models to Two-Dimensional Fluoroscopy Images,” 2003) teaches a method for registering 3D knee implant models to single plane fluoroscopy images.
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.
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/SYDNEY L BLACKSTEN/Examiner, Art Unit 2674
/ONEAL R MISTRY/Supervisory Patent Examiner, Art Unit 2674
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