DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on/after Mar. 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Response to Arguments
Applicant’s arguments (see pp. 11-14) with respect to claims 1 and 62 have been considered but are moot because the new ground of rejection (Landon et al. - U.S. Patent 11,259,874) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments (see pp. 14-15) with respect to claim 49 have been considered but are moot because the new ground of rejection (Landon et al. - U.S. Patent 11,259,874) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pp. 16-20, filed 24 March 2026, with respect to the rejection(s) of claims 26 and 87 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of LANDON in view of Mahfouz (U.S. PG-PUB 2016/0361071, 'MAHFOUZ-2016'). Please see the rationale for the rejection using the LANDON reference in the Office action below.
Applicant’s arguments (see pp. 20-22) with respect to claim 31 have been considered but are moot because the new ground of rejection (Robertson et al. ("X-Ray-Induced Acoustic Computed Tomography (XACT): Initial Experiment on Bone Sample", published April 2021) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pp. 22-26, filed 24 March 2026, with respect to claims 35 and 38 have been fully considered and are persuasive. The prior art rejections of 12 Nov. 2025 have been withdrawn.
Applicant’s arguments (see p. 26) with respect to claim 52 have been considered but are moot because the new ground of rejection (Landon et al. - U.S. Patent 11,259,874) does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 35-39 are allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 35, the prior art of record does not teach, suggest, or disclose the claim limitation “registering the pre-operative virtual 3-D model of the pelvis to the first point cloud of the pelvis obtained intra-operatively” in combination with the claim limitation “determining a first spine-pelvis tilt in the first functional position using a first relative angle of the first point cloud of the lumbar spine obtained intra-operatively to the pre-operative 3-D model of the pelvis” and further in combination with the other recited claim limitations.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-4, 23-25, 27, 49, 51-54, 56, 62-64, 84-86, and 88 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Landon et al. (U.S. Patent 11,259,874; ‘LANDON’).
Regarding claim 1, LANDON discloses a method of generating a virtual 3-D patient-specific bone model, the method comprising:
obtaining a preliminary virtual 3-D bone model of a patient's first bone (LANDON; Col. 38, Lines 9-19; “… [For example] the anatomical model is a joint, such as a knee, shoulder, or hip. … it should be understood that the model could represent various other aspects of the bony anatomy … Potential imaging modalities utilized for creation of an anatomical model may include MRI, CT, … ultrasound, etc. … the anatomical model may be subsequently subdivided or partitioned into … discrete volumes … Division of the model surfaces creates a library of similarly sub-divided bone shapes.”);
obtaining a supplemental image of the patient's first bone (LANDON; FIG. 1; Col. 10, Lines 29-37; “The Display 125 provides … (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery. … the Display 125 overlays image information … (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions.”);
registering the preliminary virtual 3-D bone model of the patient's first bone with the supplemental image of the patient's first bone (LANDON; FIG. 5; Col. 36, Lines 14-45; “… the components of the virtual model may be compared with a library of historical 2D medical images. It should be understood, that any of the various methods of image analysis discussed herein may be utilized to determine and/or identify which, if any, of the images in the historical library closely match the received image data 501. … all, or a portion, of the received 2D patient images 501 may be compared with existing 2D patient images to find a best fit or best match. Once a best-fitting historical image(s) is identified, … 3D patient image(s) may be accessed that directly correlate to the historical 2D image. … the library of historical medical images contains … 3D image(s) that correspond to each 2D patient image. Stated differently, if a patient were to visit a hospital or medical facility and have both 2D and 3D images taken of their anatomy, those images may be stored in the library of historical medical images for use by the applications discussed herein. … once a historical image has been found that closely matches each segmented (e.g., fragmented, partitioned, etc.) portion 505, the various 3D image data can be compiled and/or combined to create a hypothetical 3D model of patient's anatomy 506 … When the fragments are combined, the areas where two or more fragments meet may be normalized or smoothed. As each fragment is processed, a statistical analysis may be performed to generate the most accurate and normalized patient anatomy (e.g., the surface of a patient's bone [patient-specific bone model]), thereby ensuring the simulated bone is consistent with the shape(s) of typical bones. … once the anatomical feature (e.g., bone surface) has been properly combined, a 3D model may be generated 507.”);
extracting geometric information about the patient's first bone from the supplemental image of the patient's first bone (LANDON; Col. 40, Lines 29-34; “… a coarse bone model may be based on a selection from a collection of actual bone geometries [‘extracting geometric information about the patient's … bone’] and not a statistical model. … landmarks on the bones may be used as a means of selecting the bone that most resembles the bone depicted by the X-rays [‘supplemental images of the patient's … bone’].”); and
generating a refined virtual 3-D bone model of the patient's first bone by refining the preliminary virtual 3-D bone model of the patient's first bone using the geometric information about the patient's first bone from the supplemental image of the patient's first bone (LANDON; FIGS. 15-17; Col. 39, Lines 28-52).
Regarding claim 62, LANDON discloses a method of generating a virtual 3-D patient-specific ANATOMICAL model … ([The Examiner asserts that, since LANDON teaches the ‘method of generating a virtual 3-D patient-specific BONE model’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of generating a virtual 3-D patient-specific ANATOMICAL model’. Claim 62 is therefore rejected for the same rationale as claim 1 in the Office action above.]).
Regarding claim 2, LANDON discloses the method of claim 1, wherein obtaining the preliminary 3-D bone model comprises
obtaining a point cloud of the patient's first bone and reconstructing the preliminary 3-D bone model by morphing a generalized 3-D bone model using the point cloud of the patient's first bone (LANDON; FIG. 27; Col. 51, Lines 27-55; “… when a point 2730 on the 3D bone model is selected for adjustment, the system may access … a proximity-based point cloud that determines any and all potential positions for the corresponding points across a plurality of 3D bone models in the library. When the selected point 2730 is adjusted in a given direction …, it may “snap” to an adjacent position within the point cloud. … because the new position for the selected point 2730 corresponds to an existing point on at least one 3D image stored in the library [‘generalized 3-D bone model’], the data therefrom is used to adjust the contour [‘morphing’] of the 3D bone model to account for the new position of the selected point 2730. In an embodiment where a user manually modifies … contour(s) of the 3D bone model, visual assistance may be provided by the system. … as the selected point 2730 is adjusted, the new contour resulting from the instant position of the selected point 2730 may be displayed to the user in real time. The new contour may be illustrated by superimposing the resulting cutout or additional bone mass upon the 3D bone model (e.g., displayed as an opaque or semi-transparent feature mimicking the appearance of the bone, the 3D model, or a simulated X-ray). … any point along the periphery of the 3D bone model may be selected and repositioned according to the corresponding point cloud [‘morphing a generalized 3-D bone model using the point cloud of the patient's first bone’]. Once all contour modifications are complete, the result is a custom 3D model representing the candidate bone of the patient.”).
Regarding claim 63, LANDON discloses a method of generating a virtual 3-D patient-specific ANATOMICAL model … ([The Examiner asserts that, since LANDON teaches the ‘method of claim 1’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of claim 62’. Claim 63 is therefore rejected for the same rationale as claim 2 in the Office action above.]).
Regarding claim 3, LANDON discloses the method of claim 2, wherein
obtaining the point cloud of the patient's first bone utilizes a first imaging modality (LANDON; Col. 17, Lines 40-43; “The pre-operative data may also include images related to the anatomical area of interest. These images may be captured … using … ultrasound …”); wherein obtaining the supplemental image of the patient's first bone utilizes a second imaging modality (LANDON; FIG. 5; Col. 34, Lines 50-62; “… embodiment 500 may receive … 2D images of an anatomical feature of a patient 501. … the received image data may comprise any form of 2D patient image data, such as … X-ray data …”); and wherein the first imaging modality is different than the second imaging modality (LANDON; [The Examiner notes that ultrasound and X-ray are distinct imaging modalities.]).
Regarding claim 64, LANDON discloses a method of generating a virtual 3-D patient-specific ANATOMICAL model … ([The Examiner asserts that, since LANDON teaches the ‘method of claim 2’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of claim 63’. Claim 64 is therefore rejected for the same rationale as claim 3 in the Office action above.]).
Regarding claim 4, LANDON discloses the method of claim 3, wherein the first imaging modality comprises ultrasound (LANDON; Col. 17, Lines 40-43; “The pre-operative data may also include images related to the anatomical area of interest. These images may be captured, for example, using Magnetic Resonance Imaging (MRI), Computed Tomography (CT), X-ray, ultrasound …”).
Regarding claim 23, LANDON discloses the method of claim 1, wherein registering the preliminary 3-D bone model of the patient's first bone with the supplemental image of the patient's first bone comprises solving for a pose of the preliminary 3-D bone model which produces a 2-D projection corresponding to a projection of the supplemental image (LANDON; FIG. 15; Col. 39, Lines 21-40; “… an example [UI] is shown in which each area associated with a point (e.g., K15 points) has been matched to a level that exceeds a determined threshold. Thus, an initial or rough 3D model 1501 may be created. … the points may be projected onto the 3D bone where they intersect with the surface. … the original 2D images 1502-1503 may be overlaid, or super-imposed, on the newly created 3D model to enable a user to move the 3D model relative to the 2D images and ensure that no major errors are present. … the 3D model may remain stationary, and the 2D images may be moved in relation to the 3D model. … the movement of the 2D or 3D images may be automated, and potential problem areas may be identified autonomously or automatically. In another embodiment, the 2D images may have a known position relative to each other, such that, for example, 2D images 1502-1503 may be placed in the proper orientation and angle relative to each other.”).
Regarding claim 84, LANDON discloses the method of claim 62 … ([The Examiner asserts that, since LANDON teaches the ‘method of claim 1’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of claim 62’. Claim 84 is rejected for the same rationale as claim 23 in the Office action above.]).
Regarding claim 24, LANDON discloses the method of claim 1, wherein
obtaining a supplemental image of the patient's first bone comprises
obtaining a plurality of supplemental images of the patient's first bone (LANDON; FIG. 5; Col. 34, Lines 50-52; “… embodiment 500 may receive a plurality of 2D images of an anatomical feature of a patient 501.” Col. 34, Lines 58-60; “… the received image data may comprise any form of 2D patient image data, such as, for example, X-ray data …”); wherein
registering the preliminary virtual 3-D bone model of the patient's first bone with the supplemental image of the patient's first bone comprises
registering the preliminary virtual 3-D bone model of the patient's first bone with the plurality of supplemental images of the patient's first bone (LANDON; FIG. 5; Col. 36, Lines 14-45; “… the components of the virtual model [are] compared with a library of historical 2D medical images. … any of the various methods of image analysis discussed herein may be utilized to determine and/or identify which, if any, of the images in the historical library closely match the received image data 501. … all, or a portion, of the received 2D patient images 501 [‘plurality of supplemental images of the patient's first bone’] may be compared with existing 2D patient images to find a best fit or best match. Once a best-fitting historical image(s) is identified, … 3D patient image(s) may be accessed that directly correlate to the historical 2D image [‘registering the preliminary virtual 3-D bone model’].); wherein
extracting geometric information about the patient's first bone from the supplemental images of the patient's first bone comprises
extracting geometric information about the patient's first bone from the … supplemental images of the patient's first bone (LANDON; Col. 40, Lines 29-34; “… a coarse bone model may be based on a selection from a collection of actual bone geometries [‘extracting geometric information about the patient's … bone’] and not a statistical model. … landmarks on the bones may be used as a means of selecting the bone that most resembles the bone depicted by the X-rays [‘supplemental images of the patient's … bone’].”); and wherein
refining the preliminary virtual 3-D bone model of the patient's first bone using the geometric information about the patient's first bone from the supplemental image of the patient's first bone comprises
refining the preliminary virtual 3-D bone model of the patient's first bone using the geometric information about the patient's first bone from the … supplemental images of the patient's first bone (LANDON; FIGS. 15-17; Col. 39, Lines 28-52; “… the original 2D images 1502-1503 [‘supplemental images’] may be overlaid, or super-imposed, on the newly created 3D model [‘preliminary virtual 3-D bone model’] to enable a user to move the 3D model relative to the 2D images and ensure that no major errors are present. … the 3D model may remain stationary, and the 2D images may be moved in relation to the 3D model. … the movement of the 2D or 3D images may be automated, and potential problem areas may be identified … automatically. … once the best-matching historical images are selected for each sub-section of bone, each portion 1601-1609 may be combined together. … each point region 1610 may be identified by anatomic landmark … and historical case number 1611. Once all of the sub-sections are combined, additional fine-tuning adjustments [‘refining’] may be made to ensure that no deformities or irregularities exist at each intersection of the two sub-sections. … through a normalization process the 3D model may be converted from multiple sub-sections into a single 3D model 1701, …”).
Regarding claim 85, LANDON discloses the method of claim 62 … ([The Examiner asserts that, since LANDON teaches the ‘method of claim 1’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of claim 62’. Claim 85 is rejected for the same rationale as claim 24 in the Office action above.]).
Regarding claim 25, LANDON discloses the method of claim 1, further comprising:
obtaining a preliminary virtual 3-D bone model of a patient's second bone (LANDON; Col. 38, Lines 9-19);
obtaining a supplemental image of the patient's second bone (LANDON; FIG. 1; Col. 10, Lines 29-37);
registering the preliminary virtual 3-D bone model of the patient's second bone with the supplemental image of the patient's second bone (LANDON; FIG. 5; Col. 36, Lines 14-45);
extracting geometric information about the patient's second bone from the supplemental image of the patient's second bone (LANDON; Col. 40, Lines 29-34); and
generating a refined virtual 3-D patient-specific bone model of the patient's second bone by refining the preliminary virtual 3-D bone model of the patient's second bone using the geometric information about the patient's second bone from the supplemental image of the patient's second bone (LANDON; FIGS. 15-17; Col. 39, Lines 28-52).
Regarding claim 86, LANDON discloses the method of claim 62 … ([The Examiner asserts that, since LANDON teaches the ‘method of claim 1’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of claim 62’. Claim 86 is rejected for the same rationale as claim 25 in the Office action above.]).
Regarding claim 27, LANDON discloses the method of claim 1, wherein extracting geometric information from the supplemental image of the patient's first bone comprises
extracting at least one of a length dimension, an angular dimension, or a curvature of the patient's first bone (LANDON; FIG. 23C; Col. 45, Lines 33-62; “… the composite image 2310 may be used to determine bone size [‘length dimension … of the patient's … bone’], bone alignment, bone deformities, mechanical axis, joint line, etc. … key point(s) 2311 may be identified (e.g., manually or autonomously). … where the key points are selected manually, a user may select a measurement tool/guide 2302 to enable the points to be selected, as well as the ability to associate … point(s) with … other point(s) (e.g., to create an axis line (e.g., a mechanical axis or anatomical axis), best fit curve line, etc.). … a computing device may identify (i.e., auto-segment and/or auto-landmark) the … key point(s) (e.g., based on machine learning, artificial intelligence, artificial neural networks, or the like). The user may make manual adjustments to the automatically identified key points. … the set of key points are a pre-determined set which are desired for calculating a pre-determined set of properties of the bones. … The system may calculate … properties of the bones of the patient, such as bone size, bone length, anatomical axis, mechanical axis, etc. The system may also identify a deformity of the bone and/or calculate a degree of deformity [‘curvature of the patient's … bone’]. … a varus, valgus, and/or bow angle deformity of the femur, tibia, and/or entire leg may be calculated.”) from the supplemental image of the patient's first bone (LANDON; FIG. 23A; Col. 44, Lines 61-67 ~ Col. 45, Lines 1-5; “… an illustrative example of … received 2D images are shown (i.e., 2305A, 2305B, and 2305C) as radiograph “X-ray” images. … Each of the … 2D images may provide … sectional field(s) of view of a region of the patient's body, such that, in sum, the … 2D images capture the entirety of the bones forming the anatomy of interest (e.g., the joint).”).
Regarding claim 88, LANDON discloses the method of claim 62 … ([The Examiner asserts that, since LANDON teaches the ‘method of claim 1’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of claim 62’. Claim 88 is rejected for the same rationale as claim 25 in the Office action above.]).
Regarding claim 49, LANDON discloses a method of generating a virtual 3-D patient- specific model of a ligament, the method comprising:
obtaining a virtual 3-D patient-specific bone model of a joint (LANDON; FIG. 21; Col. 44, Lines 26-31; “Utilizing the landmarking 2103 and any calculated properties, a custom [‘patient-specific’] 3D bone model may be generated 2104 for each of the … patient bones. The 3D bone model(s) [are] combined to produce a custom estimated 3D model of a patient's anatomy 2105 (e.g. a joint comprising the … patient bones).”);
detecting at least one ligament loci on the virtual 3-D patient-specific bone model (LANDON; FIG. 21; Col. 43, Lines 4-13; “… the system may landmark 2103 the composite image (or at least one of the individual 2D images) and associate the landmarks and any further known differentiating information with the image(s). Landmarking 2103 [‘detecting’] may be performed by identifying … key point(s) with respect to the patient anatomy (e.g., bone, joint, ligament, etc.) … to further characterize the area of interest. The landmarks may be associated with the composite image and/or individual 2D images to serve as differentiating data in the process …” Col. 43, Lines 24-38; “… the key points may be related to … anatomical feature(s) and/or associated with a known portion, anatomical feature, or landmark. … the … key point(s) may refer to portions of the bony anatomy, locations of ligament attachment, and/or size and direction extremes … The key points are related to features and/or associated with a portion of an anatomical feature or landmark. … the key points may be associated with a subdivided segment. … the key points may be obtained by intersecting projected rays of 2D image landmarks in 3D space relative to a 3D candidate bone model.”);
obtaining ultrasound data pertaining to a ligament associated with the at least one ligament loci by scanning, using ultrasound, the ligament (LANDON; FIG. 23A; Col. 44, Lines 61-67; “… an illustrative example of … received 2D images are shown (i.e., 2305A, 2305B, and 2305C) as radiograph “X-ray” images. However, as discussed, various forms of 2D images are contemplated. … the 2D images may comprise … ultrasound images, and the like. Each of the … 2D images may provide … sectional field(s) of view of a region of the patient's body, such that, in sum, the … 2D images capture the entirety of the bones forming the anatomy of interest (e.g., the joint).” [The Examiner asserts that, in light of the teachings of LANDON, a ‘joint’ often contains a ligament holding at least two bones together.]); and
constructing a virtual 3-D anatomical model that includes the virtual 3-D patient-specific bone model and a virtual 3-D patient-specific ligament model using the ultrasound data (LANDON; FIG. 21; Col. 53, Lines 11-19; “… the system and/or user may simply repeat the disclosed process for each additional bone in the joint or each additional bone potentially involved in the surgical procedure. … the process 2100 may be completed by producing a custom [‘patient-specific’] [3-D] model of the joint 2105. After generating each of the custom 3D bone models, the models may be combined to produce the custom [3-D] model of the joint.”).
Regarding claim 51, LANDON discloses the method of claim 49, wherein obtaining the virtual 3-D patient-specific bone model of the joint comprises reconstructing the joint (LANDON; FIG. 21; Col. 53, Lines 11-19; “… the system and/or user may simply repeat the disclosed process for each additional bone in the joint or each additional bone potentially involved in the surgical procedure. … the process 2100 may be completed by producing a custom [‘patient-specific’] [3-D] model of the joint 2105. After generating each of the custom 3D bone models, the models may be combined to produce the custom [3-D] model of the joint.”) using ultrasound (LANDON; FIG. 23A; Col. 44, Lines 61-67).
Regarding claim 52, LANDON discloses the method of claim 51, wherein method of claim 51, wherein reconstructing the joint using ultrasound comprises obtaining … point cloud(s) associated with … bone(s) of the joint (LANDON; FIG. 27; Col. 51, Lines 27-38; “… when a point 2730 on the 3D bone model is selected for adjustment, the system may access and/or create a proximity-based point cloud that determines any and all potential positions for the corresponding points across … 3D bone models … When the selected point 2730 is adjusted in a given direction …, it may “snap” to an adjacent position within the point cloud.”).
Regarding claim 53, LANDON discloses the method of claim 49, wherein detecting the at least one ligament loci on the patient-specific virtual 3-D bone model comprises determining at least one insertion location of the ligament (LANDON; Col. 43, Lines 24-29; “… the key points may be related to … anatomical feature(s) and/or associated with a known … anatomical feature, or landmark. … the … key point(s) may refer to portions of the bony anatomy, locations of ligament attachment [‘insertion location of the ligament’] …”).
Regarding claim 54, LANDON discloses the method of claim 49, wherein scanning, using ultrasound, the ligament comprises providing automated guidance information (LANDON; Col. 56, Lines 60-64; “There are also opportunities to utilize alternate embodiments in the sports medicine space. Specifically, 2D to 3D conversion could be used to create patient specific guides for ligament tunneling used in ACL reconstruction … and/or bone preparation for focal-defect repair.”).
Regarding claim 56, LANDON discloses the method of claim 54, wherein providing the automated guidance information comprises providing a display comprising an indication of a desired location or direction of scanning (LANDON; FIG. 1; Col. 10, Lines 29-44; “The Display 125 provides … (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery. … the Display 125 overlays image information collected from various modalities (e.g., CT, MRI, X-ray, fluorescent, ultrasound, etc.) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions. … As an alternative or supplement to the Display 125, … member(s) of the surgical staff may wear an Augmented Reality (AR) Head Mounted Device (HMD). … the Surgeon 111 is wearing an AR HMD 155 that may … overlay pre-operative image data on the patient or provide surgical planning suggestions.”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 USC 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 26 and 87 are rejected under 35 U.S.C. 103 as being unpatentable over LANDON as applied to claims 25 and 86 above, and further in view of Mahfouz (U.S. PG-PUB 2016/0361071, 'MAHFOUZ-2016').
Regarding claim 26, LANDON discloses the method of claim 25,
wherein obtaining the point cloud of the patient's second bone comprises
performing an ultrasound scan of the patient's second bone (LANDON; Col. 10, Lines 22-28; “A Tissue Navigation System 120 … provides the surgeon with intraoperative, real-time visualization for the patient's bone … surrounding the surgical area. … systems that may be employed for tissue navigation include … ultrasound systems.”);
wherein obtaining the supplemental image of the patient's second bone comprises
obtaining a 2-D X-ray of the patient's second bone (LANDON; Col. 10, Lines 29-37; “The Display 125 provides … (GUIs) that display images collected by the Tissue Navigation System 120 as well other information relevant to the surgery. … the Display 125 overlays image information collected from various modalities (e.g., … X-ray …) collected pre-operatively or intra-operatively to give the surgeon various views of the patient's anatomy as well as real-time conditions.”); and
LANDON does not explicitly disclose that the 2-D X-ray of the patient's second bone includes at least one portion of the patient's second bone that was not visible on the ultrasound scan of the patient's second bone, which MAHFOUZ-2016 discloses (LANDON; ¶ 0049; “To increase the accuracy of the X-ray reconstruction (taking 2D images and creating a virtual 3D model), a hybrid approach may be utilized that makes use of ultrasound imaging to capture the surface of the non-occluded bone.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the method of claim 25 and the method of claim 86 of LANDON to include the disclosure that the 2-D X-ray of the patient's second bone includes at least one portion of the patient's second bone that was not visible on the ultrasound scan of the patient's second bone of MAHFOUZ-2016. The motivation for this modification is to utilize ultrasound to capture the areas where the patient-specific instrument will mate with the patient bone. This approach can enhance the accuracy of the interface between the patient anatomy and the generated patient-specific instruments (MAHFOUZ-2016; ¶ [0049]).
Regarding claim 87, LANDON discloses the method of claim 86 … ([The Examiner asserts that, since LANDON teaches the ‘method of claim 1’ rejected above, and a ‘bone’ is an anatomical feature, LANDON necessarily teaches the ‘method of claim 62’. Claim 86 is therefore rejected for the same rationale as claim 25 in the Office action above.]).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Robertson et al. ("X-Ray-Induced Acoustic Computed Tomography (XACT): Initial Experiment on Bone Sample", published April 2021 ‘ROBERTSON’) in view of LANDON.
Regarding claim 31, ROBERTSON discloses a method of generating a virtual 3-D patient-specific bone model, the method comprising:
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obtaining ultrasound data pertaining to an exterior surface of a first bone;
obtaining X-ray data pertaining to … an internal feature of the first bone and/or an occluded feature of the first bone (ROBERTSON; p. 1074, left col.; “As its detection is primarily ultrasonic, XACT has the potential to measure information beyond that which can be observed in a radiograph. Acoustic properties of a bone, such as elasticity and speed of sound (SOS), can be extracted from ultrasound generated due to XACT. Conventional ultrasound imaging has typically not been used to diagnose bone diseases though advances in reconstruction algorithms have shown the capability of imaging the exterior of bone [‘obtaining ultrasound data pertaining to an exterior surface of a first bone’] and, more recently, the cortical shell itself. However, ultrasound imaging of the bone interior has proved especially difficult. As an ultrasound wave progresses from soft tissue through each layer of the bone, part of the wave reflects at each boundary due to the impedance mismatch, resulting in diminished signal strength after each boundary. This is further complicated by the fact that ultrasound imaging requires two-way transmission. A wave is projected from a transducer through multiple layers of tissue; after that, it must return through each of those layers back to the transducer. When utilizing X-ray-induced ultrasound, however, the transmission is one-way; pressure waves are created in the interior of the bone [‘obtaining X-ray data pertaining to … an internal feature of the first bone and/or an occluded feature of the first bone’], which then propagates to the transducer We believe this opens up the possibility of ultrasound imaging of the bone marrow itself.”).
ROBERTSON does not explicitly disclose generating a 3-D patient-specific bone model of the first bone using the ultrasound data and the X-ray data, the 3-D patient-specific bone model representing the exterior surface of the first bone and the … internal feature of the first bone and/or the occluded feature of the first bone, which LANDON discloses (LANDON; Col. 37, Lines 53-67 ~ Col. 38, Lines 1-20; “… the embodiments … relate to an automated, or semi-automated, software tool that can create a 3D representation of a patient's anatomy (e.g., bone …) based on … bi-planar images. … the model is partitioned into subdivided surfaces (i.e., sub-surfaces) and selectively manipulated by a system, or a user, to adjust the working model to match the received 2D images 501. … the target shape of the model may be dictated by 2D images of the patient's anatomy. … fine-tuning of the patient's anatomy (e.g., … bone(s)) may leverage information gleaned from the starting point bone. … the points may best be represented on the bone … Areas that are perpendicular to the radiograph may be repositioned in the 2D image, thereby helping determine the remaining bone geometry. … the anatomical model is a joint, such as a knee, shoulder, or hip [‘generating a 3-D patient-specific bone model’]. However, it should be understood that the model could represent various other aspects of the bony anatomy … Potential imaging modalities utilized for creation of an anatomical model may include … CT, X-ray, DEXA, PET, ultrasound, etc. … the anatomical model may be subsequently subdivided … into … discrete volumes … Division of the model surfaces creates a library of similarly sub-divided bone shapes. Each of the segments in the model will have a characteristic shape with transition to neighboring segments.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the method of generating a virtual 3-D patient-specific bone model of ROBERTSON to include the generating a 3-D patient-specific bone model of the first bone using the ultrasound data and the X-ray data, the 3-D patient-specific bone model representing the exterior surface of the first bone and the … internal feature of the first bone and/or the occluded feature of the first bone of LANDON. The motivation for this modification is to utilize the penetrative quality of the x-ray modality to capture internal/occluded feature(s) and the high-resolution quality of the ultrasound modality to synthesize a realistic 3D model of bony anatomy to prepare and/or guide a surgical procedure.
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over LANDON as applied to claim 49 above and further in view of Schers et al. (U.S. PG-PUB 2009/0018445, 'SCHERS').
Regarding claim 50, LANDON discloses the method of claim 49; however, LANDON does not explicitly disclose that obtaining the ultrasound data pertaining to the ligament is performed at a plurality of joint angles of the joint across the joint's range of motion, which SCHERS discloses (SCHERS; 0062-63; “The bone tracking step requires a <<real time>>3D/3D or 3D/4D ultrasound registration algorithm (i.e. to constantly register new images to the reference volume). The 3D/3D registration algorithm described previously for building a panoramic volume can be naturally extended for tracking. This algorithm can be optimized to match (or register) the bone … to track it in real-time, using a multi-resolution approach … The algorithm can register either a 3D volume obtained in "real time" (for example, with a matrix probe) or two orthogonal ultrasound slices obtained in "real time" (for example, with a mechanical probe) to the reference volume. The initial attitude (i.e. the transformation used as the initial `guess` of the best-match search algorithm) used for the registration at the instant ti+1 can be given by the previous registration at the instant ti and should be close to the best `matched` solution. Consequently, the size of the research space is reduced and thus the registration process is faster. … the non-invasive bone tracking system is used to measure relative motion of at least two bones of a joint, in which one bone is tracked with the non-invasive ultrasonic method, and the other bone is tracked by simply attaching the marking elements 112 to the skin with straps 112 or plates. A cast could also be used to fix the second tracker to the patient, such as on the tibia or arm. To measure shoulder motion and stability, a cast can be put around the forearm and biceps to fix the elbow at a particular flexion angle, such as at 90 degrees. Scapular motion can then be measured by strapping the tracked ultrasound transducer to the spine of the scapula or near the neck of the glenoid on the posterior side.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the method of claim 49 of LANDON to include the obtaining the ultrasound data pertaining to the ligament is performed at a plurality of joint angles of the joint across the joint's range of motion of SCHERS. The motivation for this modification is to implement a computerized bone motion tracking system to provide a non-invasive means for accurate measurement and tracking of the motion of a bone using a volumetric ultrasound transducer and a 3-D position measurement system, to provide relative measurements of one bone relative to another bone of a joint, to decompose relative joint motion into specific components, and to measure joint instability and range of motion (SCHERS; Abstract).
Claims 55 and 57 are rejected under 35 U.S.C. 103 as being unpatentable over LANDON as applied to claim 54 above, respectively, and further in view of Bass et al. (U.S. Patent 6,106,464; 'BASS').
Regarding claim 55, LANDON discloses the method of claim 54; however, LANDON does not explicitly disclose that providing the automated guidance information comprises providing a display comprising a current position of an ultrasound probe relative to … anatomical structure(s), which BASS discloses (BASS; FIGS. 1, 3; Col. 7, Lines 36-48; “… surgical navigation programs 93 are available for using the model alignment and the signals supplied by the optical tracking system 25 to track the position of the surgical probe 91 as it is moved over the skull. … surgical navigation program 93 receives the position data from the position tracking system at 95 and applies at 97 the registration data from the alignment 87 to generate a representation of the position of the probe in the tomographic image which is displayed on the monitor 53 …”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the method of claim 54 of LANDON to include the providing a display comprising a current position of an ultrasound probe relative to … anatomical structure(s) of BASS. The motivation for this modification is to utilize an A-mode ultrasound transducer which is tracked in 3-D by an optical position tracking system as the transducer is scanned over skin to generate measurements of bone surface distance from the transducer. A processor correlates the ultrasound data with position and orientation data to generate a 3-D physical space model of the bone surface which is registered with an image space model of the bone surface generated from a tomographic image to produce an alignment of the two models. The ultrasound transducer is replaced by an instrument which is also optically tracked. The alignment is used to translate instrument position in physical space to a position in image space for generation on a monitor of a composite display of the instrument and the tomographic image. This composite display can be used to guide positioning and orienting the instrument in physical space with respect to sites of interest observed in the tomographic image on the display (BASS; Abstract).
Regarding claim 57, LANDON discloses the method of claim 54; however, LANDON does not explicitly disclose that providing the automated guidance information comprises providing a display comprising an A-mode , which BASS discloses (BASS; Col. 1, Lines 10-15; “This invention relates to … image-guided surgery or therapy. … it relates to apparatus which utilizes A-mode ultrasound to register physical space with a previously generated tomographic image to aid a surgeon in procedures such as brain surgery.”).
Before the effective filing date of the claimed invention, it would have been obvious to a person having ordinary skill in the art to modify the method of claim 54 of LANDON to include the providing a display comprising an A-mode of BASS. The motivation for this modification is to utilize an A-mode ultrasound transducer which is tracked in 3-D by an optical position tracking system as the transducer is scanned over skin to generate measurements of bone surface distance from the transducer. A processor correlates the ultrasound data with position and orientation data to generate a 3-D physical space model of the bone surface which is registered with an image space model of the bone surface generated from a tomographic image to produce an alignment of the two models. The ultrasound transducer is replaced by an instrument which is also optically tracked. The alignment is used to translate instrument position in physical space to a position in image space for generation on a monitor of a composite display of the instrument and the tomographic image. This composite display can be used to guide positioning and orienting the instrument in physical space with respect to sites of interest observed in the tomographic image on the display (BASS; Abstract).
Conclusion
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/JONATHAN M COFINO/Examiner, Art Unit 2614
/KENT W CHANG/Supervisory Patent Examiner, Art Unit 2614
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