MULTI-BONE PREDICTION FOR ORTHOPAEDIC PROCEDURES

Application No. 18/353,270

• Filed: Jul 17, 2023
• Examiner: ZHANG, LEI
• Art Unit: 3798
• Tech Center: 3700 — Mechanical Engineering & Manufacturing
• Assignee: Arthrex, Inc.
• OA Round: 3 (Non-Final)

Office Action

DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .

Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/01/2025 has been entered.

Response to Amendment
The amendment filed on 12/01/2025 has been entered. Claims 1, 6-8, 10-18, 23, and 25 are amended. Claims 28 and 29 are newly added. Claims 1-2, 4-8, 10-18, 21-23 and 25-29 remain pending.

Response to Arguments
Section 101 rejections
On Pages 10-11, Applicant argues that, with regard to Claims 1 and 18 and their dependent claims, the claims recite several features that are impractical to perform in the human mind. Examiner respectfully disagrees. In the argument, Applicant lists 5 features. The first feature listed by Applicant, i.e. accessing 3D bone models, is regarded as insignificant extra-solution activities in the rejections, according to MPEP 2106.05(g). The second feature listed by Applicant is to fit two 3D volumes to each other. Visually comparing different 3D objects, such as bones or organs, without using advanced image-processing tools used to be routine practice for both surgeons and radiologists, either for diagnosis or treatment planning, so it is not difficult for them to mentally check if two 3D models fit to each other, or one is significantly larger than the other, or one has a part that is missing in the other. The third feature listed by Applicant, i.e. displaying bone models, is regarded as insignificant extra-solution activities. The fourth feature listed by Applicant is to generate bone models based on image data. In the field of image processing, the procedure of generating model from image is typically termed as image segmentation. To validate a computer-based method of segmentation (e.g. active contour model or UNet), the gold standard or reference to compare against has always been the segmentation result by a human expert, who with some training has exceptional capability in segmenting objects even in fuzzy images. The fifth feature listed by Applicant is to register a model from a local reference system to a global coordinate system, which can be performed in human mind. For example, given an implant, such as a stent or a dental implant, a surgeon might visualize its type, including size and shape, and before utilizing any advanced computer-assisted tool, is capable of mentally visualizing how the implant would generally fit into the diseased region of a patient, such as a location in a specific blood vessel, to quickly determine if the implant’s size or curvature is suitable.

Art Rejections
On Pages 12-16, Applicant argues that, in rejecting independent Claim 1, Nicholson fails to disclose fitting a volume of the scapula and torso and fails to disclose comparing spatial relationships between patient and representative bone models, and there is no motivation to combine Nicholson and Moroder 2022. On Pages 17-18, Applicant argues that the rejection of independent Claim 18 should be withdrawn for at least the reasons discussed regarding Claim 1, and the rejection of Claims 12-17 and 21-22 should be withdrawn for at least the reasons discussed above regarding the base claims. The arguments above regarding Claims 1 and 18 and the dependent claims are moot in view of the new ground of rejections which relies on Penney et al to disclose the limitations in the claims. See details in section of “Claim rejections - 35 USC § 103”.
On Pages 16-17, Applicant argues that, in rejecting Claim 10, Moroder refers to “humeral component retrotorsion” rather than adjusting scapula internal rotation of a bone model. The argument is moot in view of the new ground of rejection for independent Claim 1 which relies on Penney to disclose that the humerus and the scapula can correspond to the first and second bones of Application (Penney, Para 0059; “Approaches similar to those described above can be used for a shoulder replacement surgical procedure as the shoulder and hip joints are both essentially a ball and socket type joint. The planning information for a glenoidal component will be similar to that for the acetabular cup and the planning information for the humeral component will be similar to that for the femoral component.”).
On Page 17, Applicant argues that, in rejecting Claim 23, “the viewing windows associated with the bone models are oriented at ninety degrees based on the known perpendicular orientation of the X-ray images” as disclosed in Nicholson, so “the bone models are not used to determine an acquisition orientation of the X-ray device, since it already known”. Examiner respectfully disagrees. The 90-degree angle disclosed in Nicholson is the angle between the two X-ray beams of EOS scanning system, but the claimed “acquisition orientation of an imaging device” corresponds to the angle between any one of the two X-ray beams (or the acquired X-ray image) and the object (i.e. the bones) to be imaged, which is unknown before imaging.
On Page 18, Applicant argues that, regarding the newly added Claims 28-29, Nicholson fails to disclose limitations of the claims, specifically “comparing the first spatial relationship and the second spatial relationship to each other as defined prior to at least partially fitting the volumes”. For rejection, Moroder discloses comparing the two spatial relationships without fitting the volumes. See details in section of “Claim rejections - 35 USC § 103”. In addition, it is noted that the limitations of Claims 28-29 are not disclosed in Specification, which is discussed in “Claim rejections - 35 USC § 112” below.

Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

Claims 28-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 28-29 recite “comparison/comparing … prior to at least partially fitting the volumes …”. Performing the comparison prior to the volume fitting is not specified in Specification.

Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

Claims 1-2, 4-8, 10, 18, 21-22 and 28-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.

With regard to Claims 1-2, 4-8, 10 and 28:
Step 1: the claims are drawn to a system/apparatus, one of the four statutory categories.
Step 2A, Prong One:
The claims recite the limitations of “at least partially fit …”, “assess the fit …”, “select the first representative bone model …”, “compare the first spatial relationship and the second spatial relationship …”, “determine at least one patient characteristic…”, and “establish an implant plan” in Claim 1, “patient characteristic is associated with a posture …” in Claim 2, the two bones being adjoining bones in Claim 4, the two bones being non-adjoining bones in Claim 5, “performing a range of motion simulation …” in Claim 6, “generate … bone models based on the image data” in Claim 7, “determine a deviation between …” and “determine the at least one patient characteristic ...” in Claim 8, “adjust a position of … bone model …” in Claim 10, and “perform the comparison … prior to …” in Claim 28, which are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – one or more processors operably connected to a storage system, a planning environment executable by processors, the storage system storing a plurality of 3D bone models, accessing bone models, displaying bone models, in Claim 1. The processors, the storage system and the planning environment are recited at a high-level of generality (i.e., as generic processors performing a generic computer function of data transmission, image displaying and implementing a graphic user interface) such that it amounts no more than mere instructions to apply the exception using a generic computer component. The data storing, accessing and displaying steps are insignificant extra-solution activities. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using processors, storage system and planning environment, as clamed, to perform the data storing, accessing and displaying steps amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using generic computer components cannot provide an inventive concept.
For the reasons set forth above, Claims 1-2, 4-8, 10 and 28 are not patent eligible.

With regard to Claim 18, 21-22 and 29:
Step 1: the claim is drawn to a process/method, one of the four statutory categories.
Step 2A, Prong One:
The claim recites the limitations of “at least partially fitting …”, “selecting the representative anatomical model …”, “comparing the first spatial relationship and the second spatial relationship to each other” and “determining one or more characteristics …”, “establishing an implant plan …” in Claim 18, “analyzing a representative patient population within a statistical shape model” in Claim 21, “identifying a plurality of predefined modes …”, “establishing a plurality of standard deviations …” and “varying […] the predefined modes …” in Claim 22, and “comparing the first spatial relationship and the second spatial relationship to each other” in Claim 29, which are, under their broadest reasonable interpretation, limitations that cover performance of the limitation in the mind or by mathematical calculations. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind or by mathematical calculations but for the recitation of generic computer components, then it falls within the “Mental Processes” or “Mathematical Concept” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
Step 2A, Prong Two:
This judicial exception is not integrated into a practical application. In particular, the claims recite the additional elements – using a computer to implement the method, accessing patient bone models from a memory, and displaying 3D volumes. The computer and the memory are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using a generic computer. The steps of accessing and displaying patient bone models are insignificant extra-solution activities. Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Step 2B:
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a computer to implement the method and accessing and displaying patient bone models amount to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept.
For the reason set forth above, Claims 18, 21-22 and 29 are not patent eligible.

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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.

Claims 1, 4, 7 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Penney et al (US 20210322130 A1; hereafter Penney), in view of Chaoui et al (US 20220039868 A1; hereafter Chaoui).

With regard to Claim 1, Penney discloses a surgical planning system (Penney, Abstract; “A method, apparatus and computer program code for automatically planning at least a part of a surgical procedure …”), comprising:
one or more processors (processors 402) operably connected to a storage system (Penney, Para 0100; “The data processing apparatus or computer 400 includes any number of processors 402 … A mass storage device 408 is also coupled bi-directionally to CPU 402 and provides additional data storage capacity and may include any of the computer-readable media described above.”) and configured to execute a planning environment (Penney, Para 0100; “FIG. 9 illustrates a typical computer system that, when appropriately configured or designed, can serve as the data processing apparatus or computer of the CAS system according to the invention.” Here the disclosed CAS system is the computer assisted surgery system proposed by the reference, which corresponds to the “planning environment” of Application);
wherein the storage system is configured to store a plurality of three-dimensional bone models (Penney, Para 0042; “… a SSM which can enable the variation of the shape of bones, or other anatomical structures, e.g. organs, to be captured across a population using just a few modes of variation.” The 3D bone models can be directly data from images, or as disclosed here “a few modes of variation” that capture the variation of bone shapes across the population (stored in storage 328 as disclosed in Para 0078)) associated with one or more bones of a representative patient population (Penney, Para 0068; “… sets of CT scan images of a group of N subjects are captured and the CT scan image data 302 is stored in a storage device accessible by the computing device which is used to create the SSM. The training data set 302 … only needs to provide data from which a 3D model or representation of the subject's anatomy being modelled can be derived.”; Para 0069; “The subjects may also be selected based on their having a particular condition, disease or other property affecting their anatomy and the surgical plan that would be used.”. These disclosures show that 3D model data are associated with a representative patient population), and the plurality of bone models include a first set associated with a first bone and a second set associated with a second bone (Penney, Para 0049; “… describe a surgical plan will now be given with reference to FIG. 3 which shows a diagram of the hip joint 200 and in particular the pelvis 202 and the superior part of the femur 204”. Para 0059 further discloses that surgical procedure for a shoulder (i.e. scapula and humerus) is similar to the disclosed procedure of hip joint); and
wherein the planning environment is configured to:
access a first patient three-dimensional bone model associated with the first bone of a patient (the femur for an example procedure of hip joint replacement), and access a second patient three-dimensional bone model associated with the second bone of the patient (the pelvis for an example procedure of hip joint replacement) (Penney, Para 0089; “… at step 364 the patient's anatomy is imaged using an imaging modality that also captures the image of the markers implanted in the bones.”. With the markers implanted on the bones of interest, the imaged markers in the acquired images form a model for the bone. For hip surgery, the two bones are the pelvis and the femur (see Fig. 3), and for knee surgery, the tow bones are the femur and the tibial (see Fig. 4)), wherein the first and second patient bone models establish a first spatial relationship based on a respective acquisition orientation of the first and second bones of the patient relative to each other (Penney, Para 0081; “In the described example, the procedure is a hip replacement procedure and so markers are attached to the femur and to the pelvis so that their position and orientation can be tracked.” Here the position and orientation of the femur and of the pelvis correspond to the first spatial relationship of Application);
access a first representative three-dimensional bone model of the first set of the bone models (Penney, Para 0047; “… a specific instance of the model can be approximated by x = xmean + ΣμiΦi where x is the approximated instance and μi are the weights for the first p eigenvectors to be used in the approximation.”. In this disclosure, xmean is the means shape (Para 0045), and Φ denotes the most significant modes of shape variations (Para 0046). Once the shape model is derived from a group of subjects’ data, the model is stored for use, as disclosed in Para 0076; “The data representing the SSM 318 which is used instantiate a particular SSM is stored and can then be made available for use …”) (Penney, Fig. 3, shows that the disclosed SSM can include the femur 204, corresponding to the first bone of Application), and access a second representative three-dimensional bone model of the second set of the bone models (Penney, Fig. 3, shows that the disclosed SSM can include the pelvis 202, corresponding to the second bone of Application), wherein the first and second representative bone models establish a second spatial relationship based on a respective acquisition orientation of the first and second bones of another patient of the representative patient population (A specific instance of the shape model is a group of points, as disclosed in Para 0043; “… a shape can be described using n points in d dimension … so that the positions of the n points describing the surface of the anatomical structure …”. For the example of the pelvis and the femur, selection of representative points for planning is described in Para 0050-0056. As demonstrated in Fig. 3 (cited below), these points establish spatial relationship between the pelvis and the femur. For example, line 222 of the femur and line 209 of the pelvis determine orientation of the two bones and therefore how the bones are aligned), wherein the first patient differs from the representative patient population (Penney, Para 0069-0070, discloses how the subjects of training data set 302 are selected. Obviously, these subjects differ from the patient that the invention is applied to);
at least partially fit a three-dimensional volume of the first representative bone model and a three-dimensional volume of the first patient bone model to each other (Penney, Para 0089; “Then at step 366, the SSM is instantiated using the image of the patient’s anatomy to provide the anatomy specific data to which the SSM is fitted, in a manner similar to that described above for method 330”. Here both the SSM and the patient’s specific data are 3D volumes defined by a selected group of 3D points);
assess the fit between the volumes of the first representative bone model and the first patient bone model (Penney, Para 0081; “This is generally carried out by minimizing a cost function between the captured points and the shape model data.”. Here the disclosed “cost function” is a metric of quantitatively assessing the fit between the shape model and the patient’s data);
select the first representative bone model from the first set of the bone models based on the fit between the volumes of the first representative bone model and the first patient bone model (Penney, Para 0081; “This is generally carried out by minimizing a cost function between the captured points and the shape model data.”. The disclosed optimization approach corresponds to selecting the most fitted model);
at least partially fit a three-dimensional volume of the second representative bone model and a three-dimensional volume of the second patient bone model to each other (Penney, Para 0081; “This is generally carried out by minimizing a cost function between the captured points and the shape model data.”. As the shape model and the data include the second bone, the disclosed fitting procedure would at least partially fit the shape model and the patient’s data for the second bone);
compare the first spatial relationship and the second spatial relationships to each other (Penney, Para 0089; “Then at step 366, the SSM is instantiated using the image of the patient’s anatomy to provide the anatomy specific data to which the SSM is fitted, in a manner similar to that described above for method 330”. The disclosed fitting between the SSM and the patient’s data is a matching, or comparison, between a group of corresponding points between the model and the data; on the other hand, the points establish spatial relationship between the bones (see Fig. 3 and 4 for example), so the fitting procedure intrinsically compares spatial relationship of the bones between the model (or its instance) and patient’s actual data);
display, in a display window of a graphical user interface, the three-dimensional volumes of the first and second representative models (Penney, Para 0081; “An image of the instantiated model is then created and displayed at step 342.”)
determine at least one patient characteristic associated with the first bone and/or the second bone of the patient based on the comparison of the first and second spatial relationships (In the above discussion on comparing the 2 spatial relationships, it is determined that the fitting procedure in Penney is essentially a comparison of a corresponding group of points between the shape model and the patient’s actual data, and thus of spatial relationships among the different anatomical points. Penney further discloses that some points of the SSM are for the purpose of implant planning, as in Para 0043; “the surface of an anatomical structure, e.g. a pelvis or femur, and the three dimensional planning information, can be represented as a 3(n+m)-element vector x … the m points describing the surgical planning information …”. For example, Para 0050 discloses “The separation between the two points 206, 208 is the radius of the cup … ”, in which the disclosed “cup”, or the acetabular cup is a patient characteristic that can be used for surgical planning. As a result of comparing or fitting the actual patient data and the SSM, the patient characteristics can be estimated for the patient); and
establish an implant plan based on the at least one patient characteristic (Penney, Para 0082; “The computer system takes the instantiated surgical planning point data and carries out various geometric calculations to determine the instantiated planned position and/or orientation information”; An example of using radius of the acetabular cup to plan for acetabular cup replacement is in Para 0050; “The separation between the two points 206, 208 is the radius of the cup and so describes the planned size of the implant.”).
Fig. 3 of Penney

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Penney does not clearly and explicitly disclose displaying the three-dimensional volumes of the first and second patient bone models at least partially fit to 3D volume of the representative models.
Chaoui in the same field of endeavor discloses displaying the three-dimensional volumes of the first and second patient bone models at least partially fit to 3D volume of the representative models (Chaoui, Para 0159; “FIG. 16A is a conceptual posterior three-dimensional view 690 of example final patient-specific shapes representative of the three rotator cuff muscles together with bones from patient-specific image data. As shown in FIG. 16A, the subscapularis muscle represented by patient-specific shape 676 is shown with respect to scapula 692 and humeral head 694.” In this disclosed example, the bones 692 and 694 are 3D bone model from patient’s actual image data, and the patient-specific shape 676 is an instance after fitting a statistical shape model). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, as suggested by Chaoui, in order to display 3D models from actual image data and from population- or model-based estimation in a same reference frame. One of ordinary skill in the art would have been motivated to make the modification for the benefit of visually showing the determined plan to a surgeon so that any error or discrepancy can be identified and corrected, therefore improving the success rate of a surgery.

With regard to Claim 4, Penney and Chaoui disclose the surgical planning system as recited in Claim 1. Penney further discloses wherein the first bone and the second bone are adjoining bones (Penney, Para 0049; “FIG. 3 which shows a diagram of the hip joint 200 and in particular the pelvis 202 and the superior part of the femur 204. A prosthetic hip can include two components, an acetabular cup and a femoral stem.” The disclosed pelvis and femur are adjoining bones).

With regard to Claim 7, Penney and Chaoui disclose the surgical planning system as recited in Claim 1. Penney further discloses wherein the planning environment is configured to:
receive image data associated with the patient (Penney, Para 0089; “at step 364 the patient's anatomy is imaged using an imaging modality …”); and
generate the first and second patient bone models based on the image data (Penney, Para 0094; “In an alternate embodiment in which there was no pre-operative implantation of the marker, then the pre-instantiated SSM model and plan can be registered to the patient's anatomy by using a marked pointer to indicate the position of a number of anatomical features …”; Para 0071 discloses various methods of identifying anatomical points, including manual, semi-automatic and fully automatic methods. The disclosed selected anatomical points form a model for a patient bone).

With regard to Claim 12, Penney and Chaoui disclose the surgical planning system as recited in Claim 1. Penney further discloses wherein the planning environment is configured to:
analyze the representative patient population within a statistical shape model (Penney, Para 0068; “… the CT scan image data 302 is stored in a storage device accessible by the computing device which is used to create the SSM. The training data set 302 … only needs to provide data from which a 3D model or representation of the subject's anatomy being modelled can be derived.” Here the disclosed SSM denotes “statistical shape model”).

Claims 2, 5-6, 8, 10-11, 13-18, 21-22 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Penney and Chaoui, in view of Moroder et al (Clin Orthop Relat Res (2022) 480:619-631; hereafter Moroder).

With regard to Claim 2, Penney and Chaoui disclose the surgical planning system as recited in Claim 1, but do not explicitly and clearly disclose wherein the at least one patient characteristic is associated with a posture of the patient.
Moroder in the same field of endeavor discloses wherein the at least one patient characteristic is associated with a posture of the patient (Moroder, Page 622, Column 1, Para 3; “Based on the measured scapular internal rotation, the patients were separated into three different posture types …”. The disclosed “scapular internal rotation” is an angle between two bones and can be determined from images). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to associate the determined patient characteristic with a posture. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved outcome of surgery by considering a patient’s posture in joint surgery so as to maximize range of motion (Moroder, Page 620, Column 2, Para 2; “Recently, we found in previous research that body posture and subsequent scapulothoracic orientation affect rotational balance after RTSA”).

With regard to Claim 5, Penney and Chaoui disclose the surgical planning system as recited in Claim 1, but do not explicitly and clearly disclose wherein the first bone and the second bone are non-adjoining bones.
Moroder in the same field of endeavor discloses wherein the first bone and the second bone are non-adjoining bones (Moroder, Page 622, Column 1, Para 2; “The scapular internal rotation is the angle between the scapula’s transverse axis projected onto the transverse plane and the transverse axis”. As shown in the cited Fig. 3 below, the determination of the scapular internal rotation requires orientation information of at least the spine and the scapula, which are non-adjoining). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to include two non-adjoining bones. One of ordinary skill in the art would have been motivated to make the modification for the benefit of better guidance of a surgery by properly characterizing orientation and/or position of a bone by considering a non-adjoining bone such as the spine.
Fig. 3 A-B of Moroder

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With regard to Claim 6, Penney and Chaoui disclose the surgical planning system as recited in Claim 1, but do not explicitly and clearly disclose wherein the planning environment is configured to: performing a range of motion simulation based on the at least one patient characteristic.
Moroder in the same field of endeavor discloses wherein the planning environment is configured to: performing a range of motion simulation based on the at least one patient characteristic (Moroder, Fig. 2 demonstrates range of motion (ROM) simulations performed for patients of different posture types; “Patients were grouped into three different posture types based on their scapulothoracic orientation (Types A, B, and C), and their respective simulated ROM after virtual RTSA implantation with different components and configurations was analyzed.”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to perform a range of motion simulation based on the eat least one patient characteristic. One of ordinary skill in the art would have been motivated to make the modification for the benefit of better planning and therefore outcome of a surgery by simulating range of motion of an implant or treated joint and if needed making improvement before surgery (Moroder, Page 620, Column 2, Para 3; “the degree to which a patient’s posture may influence ROM after RTSA and whether modifiable elements of implant configuration may be helpful in improving ROM among patients with different postures is unknown.”).

With regard to Claim 8, Penney and Chaoui disclose the surgical planning system as recited in Claim 1, but do not explicitly and clearly disclose wherein the planning environment is configured to:
determine a deviation between the first and second spatial relationships based on one or more landmarks associated with the first bone and/or the second bone; and
determine the at least one patient characteristic based on the deviation.
Moroder in the same field of endeavor discloses wherein the planning environment is configured to:
determine a deviation between the first and second spatial relationships based on one or more landmarks associated with the first bone and/or the second bone (Moroder, Page 622, Column 1, Para 2; “The scapular internal rotation is the angle between the scapula’s transverse axis projected onto the transverse plane and the transverse axis”. The disclosed “scapular internal rotation” corresponds to a spatial relationship that is based on multiple landmarks on the scapula and the spine (see Fig. 3 of Moroder). The measured scapular internal rotation for a patient is compared to reference rotation angles (i.e. 36⁰ and 47⁰), which correspond to second spatial relationship associated with a group of representative patients (reference 19 of Moroder)); and
determine the at least one patient characteristic based on the deviation (Moroder, Page 622, Column 1, Para 3; “The following published threshold values were used for classification purposes: Type A ≤ 36⁰, Type B > 36⁰ to 46⁰, and Type C ≥47⁰.” After comparing the scapular internal rotation of a patient against reference angle(s), deviation from the reference angle(s) can be determined, so as to determine which posture type the patient is classified to).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to determine deviation of a patient’s spatial relationship from reference data and based on the deviation determine patient’s characteristic such as posture. One of ordinary skill in the art would have been motivated to make the modification for the benefit of personalized planning for a patient’s surgery by using quantitative approach for precise subtyping a patient’s characteristic such as posture (Moroder, Page 630, Conclusion; “An individualized choice of component configuration based on scapulothoracic orientation benefits the potential ROM and could diminish the negative effects of posture Types B and C.”).

With regard to Claim 10, Penney and Chaoui disclose the surgical planning system as recited in Claim 1, but do not explicitly and clearly disclose wherein the planning environment is configured to: adjust a position of the first patient bone model and/or a position of the second patient bone model based on the at least one patient characteristic.
Moroder in the same field of endeavor discloses wherein the planning environment is configured to: adjust a position of the first patient bone model and/or a position of the second patient bone model based on the at least one patient characteristic (Moroder, Page 625, section of “Humeral Component Retrotorsion” discloses that different degrees of retrotorsion (corresponds to patient bone’s position) should be applied to humeral component of patients with different posture types (corresponds to patient characteristic)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to adjust position of patient bone based on one patient characteristic. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved surgery outcome by increasing range of motion (Moroder, Page 629, Column 1, Para 2; “Especially in patients with posture Type C, the choice of a higher retrotorsion and lower neck-shaft angle of the humeral component, as well as a larger or inferior eccentric glenosphere, seems to be advantageous.”).

With regard to Claim 11, Penney, Chaoui and Moroder disclose the surgical planning system as recited in Claim 10, but do not explicitly and clearly disclose wherein the planning environment is configured to:
register the first patient bone model and/or the second patient bone model from a local reference system to a global reference system based on the at least one patient characteristic; and
establish a surgical plan associated with the first patient bone model and/or the second patient bone model in the global reference system.
Moroder further discloses wherein the planning environment is configured to:
register the first patient bone model and/or the second patient bone model from a local reference system (the coordinate system of the scapula) to a global reference system (the coordinate system of the body) based on the at least one patient characteristic (scapulothoracic orientation) (Moroder, Page 620, Para 2 of Introduction; “Although conventional planning software references its coordinate system based on the scapula, in the present study, we created a model that references its coordinate system on the axes of the body, and thus allowed us to determine scapulothoracic orientation and posture type, as well as their effect on simulated ROM”. Fig. 3 demonstrates how the orientation angles of the scapula, which define the posture, are redefined in the global reference system); and
establish a surgical plan associated with the first patient bone model and/or the second patient bone model in the global reference system (Moroder, Fig. 2; “Overview of study methods. Whole-torso CT scans were loaded into the modified RTSA planning system, using body axes as a coordinate system”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, Chaoui and Moroder, as further suggested by Moroder, in order to establish a surgical plan in the global reference system. One of ordinary skill in the art would have been motivated to make the modification for the benefit of conveniently determining a bone’s position and/or orientation relative to other bones of patient so as to better plan a surgery (Moroder, Page 620, Para 2 of Introduction; “a model that references its coordinate system on the axes of the body, and thus allowed us to determine scapulothoracic orientation and posture type, as well as their effect on simulated ROM”).

With regard to Claim 13, Penney and Chaoui disclose the surgical planning system as recited in Claim 12. Penney further discloses a plurality of predefined modes within the statistical shape model that characterize anatomical differences within the representative patient population (Penney, Para 0044; “PCA breaks down the data into components…”; further in Para 0047; “Eigenvectors corresponding to the largest eigenvalues describe the most significant modes of variation in the training datasets used to calculate the covariance matrix”. Here the disclosed “eigenvectors” as a result of PCA correspond to the plurality of predefined modes within the statistical shape model of Application) and a plurality of standard deviations of anatomical variances contained within each of the plurality of predefined modes (Penney, Para 0048; “The calculated eigenvalues show how much variation is covered by each mode …”). Penney and Chaoui as discussed above do not explicitly and clearly disclose wherein the planning environment is configured to:
create a plurality of anatomical makeup classifications; and
assign the anatomical makeup classifications to the bone models; and the storage system configured to store the anatomical makeup classifications.
Moroder in the same field of endeavor discloses wherein the planning environment is configured to:
create a plurality of anatomical makeup classifications (Moroder, Page 622, Para 3; “The following published threshold values were used for classification purposes: Type A ≤ 36°, Type B > 36° to 46°, and Type C ≥ 47°”. The disclosed “type A, B and C” can be considered as “anatomical makeup classification”); and
assign the anatomical makeup classifications to the bone models (Moroder, Page 622, Para 3; “Based on the measured scapular internal rotation, the patients were separated into three different posture types”); and the storage system configured to store the anatomical makeup classifications (Moroder, Table 1 categorized the measured parameters of scapulothoracic orientations for the patients, based on the different posture types A, B and C).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to predefine different classifications based on statistical shape analysis and assign one of the classifications to a patient’s bone model. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving optimal outcome, such as optimal range of motion, for a patient’s surgery by subtyping the bone of interest based on its shape and making appropriate surgical plan (Moroder, Page 630, Conclusion; “An individualized choice of component configuration based on scapulothoracic orientation benefits the potential ROM and could diminish the negative effects of posture Types B and C.”).

With regard to Claim 14, Penney, Chaoui and Moroder disclose the surgical planning system as recited in Claim 13. Penney further discloses wherein the planning environment is configured to: vary one or more of the predefined modes to select the first representative bone model (Penney, Para 0048; “Linear combinations of the first few modes, for example the first five to ten, can provide an approximation to an individual patients anatomy …”. Coefficients for the disclosed “linear combination” is determined by a process of minimizing a cost function, as disclosed in Para 0081; “Then an instance of the SSM is created by fitting the captured points reflecting the patient's actual anatomy to the SSM data. This is generally carried out by minimizing a cost function between the captured points and the shape model data.”).

With regard to Claim 15, Penney, Chaoui and Moroder disclose the surgical planning system as recited in Claim 13, but do not explicitly and clearly disclose wherein the planning environment is configured to:
assign the anatomical makeup classification associated with the first representative bone model to the first patient bone model and/or assign the anatomical makeup classification associated with the second representative bone model to the second patient bone model; and
perform a range of motion simulation for the assigned anatomical makeup classification.
Moroder further discloses wherein the planning environment is configured to:
assign the anatomical makeup classification associated with the first representative bone model to the first patient bone model and/or assign the anatomical makeup classification associated with the second representative bone model to the second patient bone model (Moroder, Page 622, Column 1, Para 3; “Based on the measured scapular internal rotation, the patients were separated into three different posture types for further subgroup analysis (Type A - upright posture, retracted scapulae; Type B - intermediate; Type C - kyphotic posture with protracted scapulae) as previously described [19].”); and
perform a range of motion simulation for the assigned anatomical makeup classification (Moroder, Abstract; “For each configuration, the maximum potential ROM in different planes was determined by the software, and the effect of different posture types was analyzed by comparing subgroups.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, Chaoui and Moroder, as further suggested by Moroder, in order to assign a posture type to a patient's bone model and perform range of motion simulation based on the assigned posture. One of ordinary skill in the art would have been motivated to make the modification for the benefit of optimizing post-surgery range of motion for a bone by proper surgery planning based on patient's posture type (Moroder, Page 630, Conclusion; “An individualized choice of component configuration based on scapulothoracic orientation benefits the potential ROM and could diminish the negative effects of posture Types B and C.”).

With regard to Claim 16, Penney, Chaoui and Moroder disclose the surgical planning system as recited in Claim 13, but do not explicitly and clearly disclose wherein:
the predefined modes include a posture mode associated with posture; and
the planning environment is configured to:
assign the anatomical makeup classifications to the bone models based on the posture mode; and
determine one or more posture parameters associated with a posture of the patient based on the anatomical makeup classification associated with the first representative bone model and/or the second representative bone model.
Moroder further discloses wherein:
the predefined modes include a posture mode associated with posture (Moroder, Page 622, Para 3; “The following published threshold values were used for classification purposes: Type A ≤ 36°, Type B > 36° to 46°, and Type C ≥ 47°”); and
the planning environment is configured to:
assign the anatomical makeup classifications to the bone models based on the posture mode (Moroder, Page 622, Para 3; “Based on the measured scapular internal rotation, the patients were separated into three different posture types”); and
determine one or more posture parameters (ROM, or range of motion) associated with a posture of the patient based on the anatomical makeup classification associated with the first representative bone model and/or the second representative bone model (Moroder, Page 624, Para 4; “posture type had a strong effect on the calculated ROM in all planes of motion”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, Chaoui and Moroder, as further suggested by Moroder, in order to assign posture type based on bone model's orientation and determine range of motion based on the assigned posture type. One of ordinary skill in the art would have been motivated to make the modification for the benefit of optimizing implant configuration based on the posture type and the simulated ROM so as to achieve the optimal post-surgery ROM (Moroder, Page 630, Conclusion; “An individualized choice of component configuration based on scapulothoracic orientation benefits the potential ROM and could diminish the negative effects of posture Types B and C.”) (Moroder, Page 629, Para 2; “Several adjustments of the implant configuration based on the posture types may help to improve shoulder ROM after RTSA”).

With regard to Claim 17, Penney, Chaoui and Moroder disclose the surgical planning system as recited in Claim 16, but do not explicitly and clearly disclose wherein the planning environment is configured to: establish the implant plan based on the one or more posture parameters.
Moroder further discloses wherein the planning environment is configured to: establish the implant plan based on the one or more posture parameters (Moroder, Abstract; “scapulothoracic orientation and posture have emerged as relevant factors when planning an RTSA.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, Chaoui and Moroder, as further suggested by Moroder, in order to establish an implant plan based on scapulothoracic orientation, posture and/or the simulated ROM. One of ordinary skill in the art would have been motivated to make the modification for the benefit of achieving a balanced range of motion for the treated bone or joint after surgery (Moroder, Page 629, Para 3; “… to achieve balanced ROM, the humeral component's retrotorsion must be individually adapted to the scapulothoracic orientation and thus the patient's posture”).

With regard to Claim 18, Penney discloses a computer implemented surgical planning method comprising the steps of:
accessing a first patient three-dimensional bone model of a patient from memory (the pelvis for an example procedure of hip joint replacement) (Penney, Para 0089; “… at step 364 the patient's anatomy is imaged using an imaging modality that also captures the image of the markers implanted in the bones.”. With the markers implanted on the bones of interest, the imaged markers in the acquired images form a model for the bone. For hip surgery, the two bones are the pelvis and the femur (see Fig. 3)), the first patient model associated with a first bone of a patient (the femur, as shown in Fig. 3);
accessing a second patient three-dimensional bone model of the patient from the memory, the second patient bone model associated with a second bone of the patient (the pelvis, as shown in Fig. 3), wherein the first and second patient bone models establish a first spatial relationship based on a respective acquisition orientation of the first and second bones of the patient relative to each other (Penney, Para 0081; “In the described example, the procedure is a hip replacement procedure and so markers are attached to the femur and to the pelvis so that their position and orientation can be tracked.” Here the position and orientation of the femur and of the pelvis correspond to the first spatial relationship of Application);
at least partially fitting a three-dimensional volume of a representative anatomical model and a three-dimensional volume of the first and second patient bone models to each other (Penney, Para 0089; “Then at step 366, the SSM is instantiated using the image of the patient’s anatomy to provide the anatomy specific data to which the SSM is fitted, in a manner similar to that described above for method 330”. Here both the SSM and the patient’s specific data are 3D volumes defined by a selected group of 3D points);
selecting the representative anatomical model from a plurality of representative three-dimensional anatomical models based on the fit between the volumes (Penney, Para 0081; “This is generally carried out by minimizing a cost function between the captured points and the shape model data.”. The disclosed optimization approach corresponds to selecting the most fitted model), wherein the plurality of representative anatomical models are associated with one or more bones and/or one or more joints of a representative patient population (Penney, Para 0068; “… sets of CT scan images of a group of N subjects are captured and the CT scan image data 302 is stored in a storage device accessible by the computing device which is used to create the SSM. The training data set 302 … only needs to provide data from which a 3D model or representation of the subject's anatomy being modelled can be derived.”; Para 0069; “The subjects may also be selected based on their having a particular condition, disease or other property affecting their anatomy and the surgical plan that would be used.”. These disclosures show that 3D model data are associated with a representative patient population) including at least the first bone and the second bone (Penney, Para 0049; “… describe a surgical plan will now be given with reference to FIG. 3 which shows a diagram of the hip joint 200 and in particular the pelvis 202 and the superior part of the femur 204”. Para 0059 further discloses that surgical procedure for a shoulder (i.e. scapula and humerus) is similar to the disclosed procedure of hip joint), the selected representative anatomical model includes a first representative three-dimensional bone model associated with the first bone (Penney, Para 0047; “… a specific instance of the model can be approximated by x = xmean + ΣμiΦi where x is the approximated instance and μi are the weights for the first p eigenvectors to be used in the approximation.”. In this disclosure, xmean is the means shape (Para 0045), and Φ denotes the most significant modes of shape variations (Para 0046). Once the shape model is derived from a group of subjects’ data, the model is stored for use, as disclosed in Para 0076; “The data representing the SSM 318 which is used instantiate a particular SSM is stored and can then be made available for use …”) and a second representative three-dimensional bone model associated with the second bone (Penney, Fig. 3, shows that the disclosed SSM can include the pelvis 202, corresponding to the second bone of Application), the first and second representative bone models establish a second spatial relationship based on a respective acquisition orientation of the first and second bones of another patient (A specific instance of the shape model is a group of points, as disclosed in Para 0043; “… a shape can be described using n points in d dimension … so that the positions of the n points describing the surface of the anatomical structure …”. For the example of the pelvis and the femur, selection of representative points for planning is described in Para 0050-0056. As demonstrated in Fig. 3 (cited above), these points establish spatial relationship between the pelvis and the femur. For example, line 222 of the femur and line 209 of the pelvis determine orientation of the two bones and therefore how the bones are aligned), and the first patient differs from the representative patient population (Penney, Para 0069-0070, discloses how the subjects of training data set 302 are selected. Obviously, these subjects differ from the patient that the invention is applied to);
comparing the first spatial relationship and the second spatial relationship to each other (Penney, Para 0089; “Then at step 366, the SSM is instantiated using the image of the patient’s anatomy to provide the anatomy specific data to which the SSM is fitted, in a manner similar to that described above for method 330”. The disclosed fitting between the SSM and the patient’s data is a matching, or comparison, between a group of corresponding points between the model and the data; on the other hand, the points establish spatial relationship between the bones (see Fig. 3 and 4 for example), so the fitting procedure intrinsically compares spatial relationship of the bones between the model (or its instance) and patient’s actual data);
displaying, in a display window of a graphical user interface, the three-dimensional volumes of the anatomical model (Penney, Para 0081; “An image of the instantiated model is then created and displayed at step 342.”);
determining one or more characteristics based on the comparison of the first and second spatial relationships (In the above discussion on comparing the 2 spatial relationships, it is determined that the fitting procedure in Penney is essentially a comparison of a corresponding group of points between the shape model and the patient’s actual data, and thus of spatial relationships among the different anatomical points. Penney further discloses that some points of the SSM are for the purpose of implant planning, as in Para 0043; “the surface of an anatomical structure, e.g. a pelvis or femur, and the three dimensional planning information, can be represented as a 3(n+m)-element vector x … the m points describing the surgical planning information …”. For example, Para 0050 discloses “The separation between the two points 206, 208 is the radius of the cup … ”, in which the disclosed “cup”, or the acetabular cup is a patient characteristic that can be used for surgical planning. As a result of comparing or fitting the actual patient data and the SSM, the patient characteristics can be estimated for the patient); and
establishing an implant plan associated with the first bone and/or the second bone of the patient based on the step of determining the one or more characteristics (Penney, Para 0082; “The computer system takes the instantiated surgical planning point data and carries out various geometric calculations to determine the instantiated planned position and/or orientation information”; An example of using radius of the acetabular cup to plan for acetabular cup replacement is in Para 0050; “The separation between the two points 206, 208 is the radius of the cup and so describes the planned size of the implant.”).
Penney does not clearly and explicitly disclose displaying the first and second patient bone models at least partially fit to 3D volume of the anatomical model, and the one or more characteristics being associated with a posture of the patient.
Chaoui in the same field of endeavor discloses displaying the first and second patient bone models at least partially fit to 3D volume of the anatomical model (Chaoui, Para 0159; “FIG. 16A is a conceptual posterior three-dimensional view 690 of example final patient-specific shapes representative of the three rotator cuff muscles together with bones from patient-specific image data. As shown in FIG. 16A, the subscapularis muscle represented by patient-specific shape 676 is shown with respect to scapula 692 and humeral head 694.” In this disclosed example, the bones 692 and 694 are 3D bone model from patient’s actual image data, and the patient-specific shape 676 is an instance after fitting a statistical shape model). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, as suggested by Chaoui, in order to display patient bone model and anatomical model in a same reference frame. One of ordinary skill in the art would have been motivated to make the modification for the benefit of visually showing the determined plan to a surgeon so that any error or discrepancy can be identified and corrected, therefore improving the success rate of a surgery.
Penney and Chaoui do not explicitly and clearly disclose the one or more characteristics being associated with a posture of the patient.
Moroder in the same field of endeavor discloses the one or more characteristics being associated with a posture of the patient (Moroder, Page 622, Column 1, Para 3; “Based on the measured scapular internal rotation, the patients were separated into three different posture types …”. The disclosed “scapular internal rotation” is an angle between two bones and can be determined from images). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to associate the determined patient characteristic with a posture. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved outcome of surgery by considering a patient’s posture in joint surgery so as to maximize range of motion (Moroder, Page 620, Column 2, Para 2; “Recently, we found in previous research that body posture and subsequent scapulothoracic orientation affect rotational balance after RTSA”).

With regard to Claim 21, Penney, Chaoui and Moroder disclose the method as recited in Claim 18. Penney further discloses wherein the selecting step includes analyzing the representative patient population within a statistical shape model (Penney, Para 0068; “… the CT scan image data 302 is stored in a storage device accessible by the computing device which is used to create the SSM. The training data set 302 … only needs to provide data from which a 3D model or representation of the subject's anatomy being modelled can be derived.” Here the disclosed SSM denotes “statistical shape model”).

With regard to Claim 22, Penney, Chaoui and Moroder disclose the method as recited in Claim 21. Penney further discloses comprising:
identifying a plurality of predefined modes within the statistical shape model of the representative patient population (Penney, Para 0044; “PCA breaks down the data into components…”; further in Para 0047; “Eigenvectors corresponding to the largest eigenvalues describe the most significant modes of variation in the training datasets used to calculate the covariance matrix”. Here the disclosed “eigenvectors” as a result of PCA correspond to the plurality of predefined modes within the statistical shape model of Application);
establishing a plurality of standard deviations of anatomical variances contained within each of the plurality of predefined modes (Penney, Para 0048; “The calculated eigenvalues show how much variation is covered by each mode …”); and
wherein the step of selecting the anatomical model includes varying one or more of the predefined modes within the statistical shape model (Penney, Para 0048; “Linear combinations of the first few modes, for example the first five to ten, can provide an approximation to an individual patients anatomy …”. Coefficients for the disclosed “linear combination” is determined by a process of minimizing a cost function, as disclosed in Para 0081; “Then an instance of the SSM is created by fitting the captured points reflecting the patient's actual anatomy to the SSM data. This is generally carried out by minimizing a cost function between the captured points and the shape model data.”).
Penney, Chaoui and Moroder as discussed above do not explicitly and clearly disclose the predefined modes including a posture mode associated with posture.
Moroder further discloses the predefined modes including a posture mode associated with posture (Moroder, Page 622, Para 3; “The following published threshold values were used for classification purposes: Type A ≤ 36°, Type B > 36° to 46°, and Type C ≥ 47°”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, Chaoui and Moroder, as further suggested by Moroder, in order to define and classify bone shapes by a posture of patient. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved outcome of a surgery, such as optimal range of motion for a post-surgery joint, by customizing a patient’s surgical planning by considering characteristics such as posture (Moroder, Page 630, Conclusion; “An individualized choice of component configuration based on scapulothoracic orientation benefits the potential ROM and could diminish the negative effects of posture Types B and C.”) (Moroder, Page 629, Para 2; “Several adjustments of the implant configuration based on the posture types may help to improve shoulder ROM after RTSA”).

With regard to Claim 28, Penney and Chaoui disclose the surgical planning system as recited in Claim 1, but do not explicitly and clearly disclose wherein the planning environment is configured to: perform the comparison of the first spatial relationship and the second spatial relationship to each other as defined prior to at least partially fitting the volumes of the first and second representative bone models and the first and second patient bone models to each other.
Moroder in the same field of endeavor discloses wherein the planning environment is configured to: perform the comparison of the first spatial relationship and the second spatial relationship to each other as defined prior to at least partially fitting the volumes of the first and second representative bone models and the first and second patient bone models to each other (Moroder, Page 622, Para 3; “Based on the measured scapular internal rotation, the patients were separated into three different posture types … as previously described [19]. The following published threshold values were used for classification purposes: Type A ≤ 36°, Type B > 36° to 46°, and Type C ≥ 47°”. In this disclosure, scapular internal rotation determined for a patient is directly compared against a second rotation angle (e.g. 36° or 47°) based on a representative patient population (the patient group in reference 19 of Moroder), without fitting volumes of the corresponding bones to each other). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney and Chaoui, as suggested by Moroder, in order to compare spatial relationship of two bones between a patient and another patient from a reference population without fitting volume of the corresponding bones to each other. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved efficiency of surgical planning by classifying a patient using a simple threshold approach, without the need of performing multiple-parameter and compute-intensive optimization.

With regard to Claim 29, Penney, Chaoui and Moroder disclose the method as recited in Claim 18, but do not explicitly and clearly disclose wherein the comparing step includes comparing the first spatial relationship and the second spatial relationship to each other as defined prior to at least partially fitting the volumes of the representative anatomical model and the first and second patient bone models to each other.
Moroder further discloses wherein the comparison step includes comparing the first spatial relationship and the second spatial relationship to each other as defined prior to at least partially fitting the volumes of the representative bone models and the first and second patient bone models to each other (Moroder, Page 622, Para 3; “Based on the measured scapular internal rotation, the patients were separated into three different posture types … as previously described [19]. The following published threshold values were used for classification purposes: Type A ≤ 36°, Type B > 36° to 46°, and Type C ≥ 47°”. In this disclosure, scapular internal rotation determined for a patient is directly compared against a second rotation angle (e.g. 36° or 47°) based on a representative patient population (the patient group in reference 19 of Moroder), without fitting volumes of the corresponding bones to each other). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Penney, Chaoui and Moroder, as further suggested by Moroder, in order to compare spatial relationship of two bones between a patient and another patient from a reference population without fitting volume of the corresponding bones to each other. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improved efficiency of surgical planning by classifying a patient using a simple threshold approach, without the need of performing multiple-parameter and compute-intensive optimization.

Claims 23 and 25-27 are rejected under 35 U.S.C. 103 as being unpatentable over Nicholson et al (Medical Engineering and Physics 41 (2017) 103-108; hereafter Nicholson), in view of Moroder.

With regard to Claim 23, Nicholson discloses a surgical planning system, comprising:
one or more processors and memory operably coupled to the one or more processors (Nicholson, Page 104, Para 4; “Each 3D model was saved as a VRML model and loaded into custom software …”. To perform the disclosed operations of storing 3D model data and implementing the custom software, processors and memory are intrinsically available); and
wherein the one or more processors are configured to execute a planning environment (Nicholson, Fig. 3 shows a graphical user interface that corresponds to the planning environment of Application), and the planning environment is configured to:
receive image data including first and second two-dimensional images (images acquired by the right X-ray beam and the left X-ray beam) of first and second bones (scapula and torso) of a first patient (Nicholson, Page 104, Paras 5 and 6; “Two scapulae (one left, one right) were attached to the humeral heads [...] the torso, with attached scapulae, was moved into an EOS (EOS Imaging, Cambridge, MA) scanning volume [...] This orientation resulted in the right X-ray beam being approximately perpendicular to the left scapular plane, and the left X-ray beam being approximately perpendicular to the right scapular plane.” In this disclosure, a skeletal model of a human torso attached with two scapulas is used to simulate a patient, and two X-ray images are acquired with the right and the left X-ray beam);
generate a first profile of the first and second bones along a first reference plane associated with the first image (Nicholson, Fig. 3A, the left panel displays a first profile of the bones in the first X-ray image);
generate a second profile of the first and second bones along a second reference plane associated with the second image (Nicholson, Fig. 3A, the right panel displays a second profile of the bones in the second X-ray image);
access a representative anatomical model associated with a second patient (Nicholson, Page 104, Para 4; “Each 3D model was saved as a VRML model … the other two models served as the generic scapula models”. In this disclosure, 3D models for two of the twelve scapulae are used as generic model to fit to image data of the other ten scapulae, and can be regarded as model associated with a different patient), wherein the representative anatomical model includes a first three-dimensional representative bone model associated with the first bone (Nicholson, Page 104, Para 4; “Each scapula was scanned and a 3D cloud was exported … Each 3D model was saved as a VRML model and loaded into custom software to establish coordinate systems that matched recommendations of the International Shoulder Group [16].”) and a second three-dimensional representative bone model associated with the second bone (Nicholson, Page 104, Para 5; “The skeleton torso was placed in the viewing volume of the motion capture system. A triad of three 7 mm spherical retroreflective markers was placed on the sternum.” The disclosed “triad markers” attached to the torso is used to track 3D orientation of the torso, as demonstrated in Fig. 3 and explained in Page 105, Para 3, so can be interpreted as a 3D model of the torso);
determine an orientation of the first and second bones of the first patient based on an orientation associated with the first and second three-dimensional bone models of the representative anatomical model associated with the second patient (Nicholson, Page 105, Para 4; “After alignment was achieved, the helical angle between the VRML trunk triad orientation and the VRML scapula orientation was recorded”. As the VRML trunk triad and the VRML scapula are fitted to the X-ray images, the orientation of these VRML models is the same as the bones in the X-ray images, i.e. orientation of the bones of the first patient is determined), including projecting a first silhouette of the representative anatomical model from a first camera angle onto the first profile along the first reference plane (Nicholson, Page 105, Para 1; “The 3D viewing windows were oriented to match the corresponding orientation of the underlying X-ray images.”) (Nicholson, Fig. 3, the sub-figures on the left column show a first profile along a first reference plane), adjusting the first camera angle relative to the representative anatomical model to adjust the first silhouette (Nicholson, Page 105, Para 3; "Matching was initiated with the trunk triad object by superimposing the top object marker over the corresponding triad marker in the X-ray images."; Para 4; “The scapula model was then rotated about that point until it matched the alignment in the X-ray image.” The sub-figures on the left side of Fig. 3B and 3C show a first silhouette), projecting a second silhouette of the representative anatomical model from a second camera angle onto the second profile along the second reference plane (Nicholson, Page 105, Fig. 3 - the sub-figures on the right column show a second profile along a second reference plane), adjusting the second camera angle relative to the representative anatomical model to adjust the second silhouette (Nicholson, Page 105, the sub-figures on the right side of Fig. 3B and 3C shows a second silhouette, which can be adjusted by rotating the VRML triad and the 3D scapula model), determining a first acquisition orientation of an imaging device associated with the first image based on a fit between the first silhouette and the first profile (Nicholson, Page 104, Column 2, Para 4; “The trunk’s coordinate system was created using the three triad markers: …”. In this disclosure, the disclosed triad defines the coordinate system. When a 2D projection of the VRML triad is fitted to the profile of the triad in the X-ray image on the left column of Fig. 3B (after the matching process described in Page 105, Para 3), acquisition orientation of the X-ray image in the coordinated system defined by the triad is determined), and determining a second acquisition orientation of the imaging device associated with the second image based on a fit between the second silhouette and the second profile (the matching process is also performed for the X-ray image on the right column of Fig. 3B, and as a result, the orientation of this image is also determined); and
determine one or more posture characteristics (the helical angle, or the scapulothoracic (ST) orientation or angle) associated with a posture of the first patient based on the determined orientation of the first and second bones of the first patient and the first and second acquisition orientations of the imaging device (Nicholson, Page 105, Para 4; “After alignment was achieved, the helical angle between the VRML trunk triad orientation and the VRML scapula orientation was recorded”).
Nicholson does not clearly and explicitly disclose establishing a surgical plan associated with the first bone and/or the second bone based on the one or more posture characteristics.
Moroder in the same field of endeavor discloses establishing a surgical plan associated with the first bone and/or the second bone based on the one or more posture characteristics (Moroder, Abstract; “scapulothoracic orientation and posture have emerged as relevant factors when planning an RTSA”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Nicholson, as suggested by Moroder, in order to establish a surgical plan based on posture characteristics. One of ordinary skill in the art would have been motivated to make the modification for the benefit of improving range of motion for a treated joint by taking into consideration the patient’s posture characteristics in surgical planning (Moroder, Page 629, Para 2; “Several adjustments of the implant configuration based on the posture types may help to improve shoulder ROM after RTSA”).

With regard to Claim 25, Nicholson and Moroder disclose the surgical planning system as recited in Claim 23. Nicholson further discloses wherein the planning environment is configured to:
iteratively adjust a projection of the first silhouette from the first camera angle onto the first profile along the first reference plane to determine the first acquisition orientation (Nicholson, Page 105, Para 3; “Matching was initiated with the trunk triad object [...] Once aligned, the top object marker was “anchored”, and the remaining two markers were matched by rotating the VRML triad about the anchor point.” Obviously, the matching process by a user is a process of iterative adjustment); and
iteratively adjust a projection of the second silhouette from the second camera angle onto the second profile along the second reference plane to determine the second acquisition orientation (Nicholson, Page 105, Para 3; “The 3D viewing windows were synched, so that transforming an object in one window simultaneously transformed that object in the paired window.” This disclosure indicates that the matching or adjustment is done in both the windows of Fig. 3B, which correspond to the first and second reference plane of Application).

With regard to Claim 26, Nicholson and Moroder disclose the surgical planning system as recited in Claim 23. Nicholson further discloses wherein the first reference plane and the second reference plane are perpendicular to each other (Nicholson, Abstract; “A biplane X-ray system from EOS Imaging was used to collect two orthogonal 2D images of the skeleton and markers”).

With regard to Claim 27, Nicholson and Moroder disclose the surgical planning system as recited in Claim 23. Nicholson further discloses wherein the first bone is associated with a scapula of the first patient (Nicholson, Page 104, Para 4; “three dimensional scapula models”), and the second bone is associated with a humerus of the first patient (Nicholson, Page 104, Para 5; “a human torso (rib cage, sternum, spine, clavicles, and humeri)”; also see Fig. 2 where two humeri are attached to the scapulas).

Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEI ZHANG whose telephone number is [phone]. The examiner can normally be reached Monday-Friday 8am-5pm E.T..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at [phone]. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.Z./ Examiner, Art Unit 3798

/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798

Prosecution Timeline

• Jul 17, 2023: Application Filed
• Apr 30, 2025: Non-Final Rejection — §101, §103, §112
• May 12, 2025: Interview Requested
• May 21, 2025: Applicant Interview (Telephonic)
• May 21, 2025: Examiner Interview Summary
• Jul 02, 2025: Applicant Interview (Telephonic)
• Jul 02, 2025: Examiner Interview Summary
• Jul 23, 2025: Response Filed
• Aug 07, 2025: Final Rejection — §101, §103, §112
• Oct 15, 2025: Applicant Interview (Telephonic)
• Oct 15, 2025: Examiner Interview Summary
• Oct 21, 2025: Response after Non-Final Action
• Dec 01, 2025: Request for Continued Examination
• Dec 17, 2025: Response after Non-Final Action
• Feb 11, 2026: Non-Final Rejection — §101, §103, §112 (current)