DETAILED ACTION
*Note in the following document:
1. Texts in italic bold format are limitations quoted either directly or conceptually from claims/descriptions disclosed in the instant application.
2. Texts in regular italic format are quoted directly from cited reference or Applicant’s arguments.
3. Texts with underlining are added by the Examiner for emphasis.
4. Texts with
5. Acronym “PHOSITA” stands for “Person Having Ordinary Skill In The Art”.
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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claim(s) 1-6 and 8-20 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over various claims of U.S. Patent No. 11,707,327 B2.
Instant Application:
US 11,707,327 B2:
Claim 1. A method, comprising:
providing a system including a computer, a server, and a model generator;
constructing, with the model generator, a three-dimensional model associated with a target patient based on x-ray images of the spine of the target patient;
acquiring, from the server, medical data associated with a reference patient different from the target patient;
analyzing, with the computer, the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient; and
predicting, with the computer, postoperative changes to the spine of the target patient to determine a surgical plan for the patient based on the analysis of the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient.
Claim 1. A method, comprising:
obtaining a first X-ray image of at least a portion of a spine of a target patient in a first plane;
obtaining a second X-ray image of the at least a portion of the spine of the target patient in a second plane;
drawing a line through vertebral bodies of the at least a portion of the spine of the target patient in the first X-ray image and in the second X-ray image;
constructing a three-dimensional model associated with the target patient based on the lines drawn on the first and second X-ray images;
acquiring medical data associated with a reference patient different from the target patient;
predicting, based on the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient, postoperative changes to movement of the spine of the target patient over time; and
determining parameters of a spinal device based on the predicted postoperative changes to movement of the spine of the target patient.
Claim 19. The method of claim 1, wherein acquiring the medical data associated with the reference patient different from the target patient includes obtaining at least one four-dimensional model for a similar spine of the reference patient.
20. The method of claim 19, further comprising:
analyzing the three-dimensional model associated with the target patient based on the at least one four-dimensional model for the similar spine of the reference patient to predict movement of the spine of the target patient; and
determining the parameters of the spinal device based on the predicted movement of the spine of the target patient.
Claim 2
Claim 20
Claim 3
Claim 2
Claim 4
Claim 3
Claim 5
Claim 24
Claim 6
Claim 14
Claim 7
Claim 8
Claim 15
Claim 9
Claim 17
Claim 10
Claim 18
Claim 11
Claim 20
Claim 12
Claim 21
Claim 13
Claim 1
Claim 14
Claim 4
Claim 15
Claim 1
Claim 16
Claim 8
Claim 17
Claim 9
Claim 18
Claim 11
Claim 19
Claim 12
Claim 20
Claim 13
Claims 1-12, 16-19 is/are further provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over various claims of copending Application No. 19/303,753. Although the claims at issue are not identical, they are not patentably distinct from each other because the claim of the instant application is either anticipated by, or the obvious variation of, the claim of copending application, as shown in the table below.
Instant Application:
Co-pending Application: 19/303,753
Claim 1. A method, comprising:
providing a system including a computer, a server, and a model generator;
constructing, with the model generator, a three-dimensional model associated with a target patient based on x-ray images of the spine of the target patient;
acquiring, from the server, medical data associated with a reference patient different from the target patient;
analyzing, with the computer, the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient; and
predicting, with the computer, postoperative changes to the spine of the target patient to determine a surgical plan for the patient based on the analysis of the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient.
Claim 1. A method, comprising:
providing a system including a computer, a server, and a model generator;
receiving, at the model generator, a curve representation of an arrangement of a plurality of identified anatomical structures visible in a plurality of x-ray images of the spine of a target patient;
constructing, with the model generator, a three-dimensional model associated with the target patient based on the curve representation of the target patient;
acquiring, from the server, medical data associated with a reference patient different from the target patient;
analyzing, with the computer, the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient; and
predicting, with the computer, postoperative changes to the spine of the target patient to determine a surgical plan for the patient based on the analysis of the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient.
Claim 2
Claim 2
Claim 3
Claim 3
Claim 4
Claim 4
Claim 5
Claim 5
Claim 6
Claim 10
Claim 7
Claim 11
Claim 8
Claim 12
Claim 9
Claim 13
Claim 10
Claim 14
Claim 11
Claim 15
Claim 12
Claim 16
Claim 13
Claim 14
Claim 15
Claim 16
Claim 18
Claim 17
Claim 19
Claim 18
Claim 20
Claim 19
Claim 20
Claim 20
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
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.
Claim 15 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 15 recites The method of claim 13, further comprising obtaining a third X-ray image of the at least a portion of the spine of the target patient in an axial plane; and wherein constructing the three-dimensional model associated with the target patient includes constructing the three-dimensional model associated with the target patient based on the lines drawn on the first, second, and third X-ray images.
Claim 15 recites constructing the 3D model based on a line drawn on the axial plane image. However the specification fails to describe how to draw a line on a transverse/axial plane of X-ray images since there is no curve line seen from horizontal plane (viewing a patient from below his/her feet). For compact examination purpose, the Examiner interprets Claim 15 as if Applicant intends to claim constructing the three-dimensional model associated with the target patient based on the lines drawn on the first, second images, and the third X-ray image.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-2 and 4-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller (US 2011/0019791 A1) in view of Steines et al. (US 20140228860 A1).
Regarding Claim 1, Mueller teaches or suggests a method, comprising:
providing a system including a computer, a server, and a model generator (Fig.5 and [0047]: The computer program product can be stored on hard disk drives within the processing unit 510, as mentioned, or can be located on a remote system such as a server 530, coupled to the processing unit 510, via a network interface such as an Ethernet interface or wireless connection);
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constructing, with the model generator, a three-dimensional model associated with a target patient based on x-ray images of the spine of the target patient ([0010]: According to an aspect of the present invention, a method of operating a computed tomography apparatus includes: selecting a set of viewing angles based on a model representing geometry of an object to be scanned; generating projections of the object by scanning the object at the set of viewing angles; and generating a computed tomography image from the projections. [0041]: Employing such methods for new previously unseen objects, likely new objects can then be created by interpolating in a "space of objects." CT reconstruction algorithms based on this concept seek to match the projections to these likely objects via some optimization procedures known in the art, such as those disclosed in S. Kadoury et al., "Personalized X-Ray 3-D Reconstruction of the Scoliotic Spine From Hybrid Statistical and Image-Based Models," IEEE Trans Medical Imaging, 28(9):1422-1435, 2009 and …).
Mueller fails to disclose acquiring, from the server, medical data associated with a reference patient different from the target patient; analyzing, with the computer, the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient; and predicting, with the computer, postoperative changes to the spine of the target patient to determine a surgical plan for the patient based on the analysis of the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient.
However Steines discloses automated systems, devices and methods that facilitate the design, selection, manufacturing and/or implantation of improved and/or patient-adapted (e.g., patient-specific and/or patient-engineered) orthopedic implants and guide tools, as well as associated methods, designs and models (Abstract). Steines further discloses the implant method can be used in spinal implants ([0012]: In various embodiments, the articular implant component (as well as any subsequent revision components) can be a knee joint implant component, a hip joint implant component, a shoulder joint implant component, or a spinal implant component).
Steines further teaches or suggests
acquiring, from the server, medical data associated with a reference patient different from the target patient ([0061]: Next, utilizing various of the collected, modified and/or derived patient-specific information (as well as any optional weighting parameters), the automated system can attempt to identify one or more "matching subjects" from one or more reference databases, comparing features from the matching subject to the patient-specific information, and optionally creating a comparison or "weighting score" to evaluate and display the results of the various comparisons (relative to individual feature comparisons and/or an overall composite score for the comparison of each subject). The databases can comprise information from various sources, including cadaveric data, imaging, biomechanical or kinematic data, historic data and/or … [0080]: Data, models and/or any related guide tools or implant components can be collected in one or more libraries for subsequent use for the same patient or for a different patient (e.g., a different patient with similar data). [0118]: Cartilage models and estimates of cartilage thickness can also be derived from anatomic reference databases that can be matched, for example, to a patient's weight, sex, height, race, gender, or articular geometry(ies). [0184]: A standard thickness can be added to the joint-facing surface, for example, to reflect an average cartilage thickness. Alternatively, a variable thickness can be applied to the component. The variable thickness can be selected to reflect a patient's actual or healthy cartilage thickness, for example, as measured in the individual patient or selected from a standard reference database. );
analyzing, with the computer, the three-dimensional model associated with the target patient in view of the medical data associated with the reference patient (Fig.9 and [0079]-[0081]: Then, the data can be presented as part of a model 950, for example, a patient-specific virtual model that includes the biological feature of interest. … Moreover, the program could proceed directly 933 from the step of segmenting image data 930 to presenting and/or utilizing the data as part of a model 950. Data, models and/or any related guide tools or implant components can be collected in one or more libraries for subsequent use for the same patient or for a different patient (e.g., a different patient with similar data) … In a similar manner, the various anatomical features of any joint can be measured and then compared/modified based on a database of "healthy" or otherwise appropriate measurements of appropriate joints, including those of the medial condyle, …, spine, or facet joint); and
predicting ([0056]: Various methods and techniques described herein can enable an automated system to utilize patient anatomical data in modeling and/or otherwise approximating anatomical features of interest for a given patient, and then utilize these models/approximations in various ways to derive and/or select an appropriate surgical plan and/or associated implant components). It would have been obvious to a PHOSITA before the effective filing date of the claimed invention to choose a plan which generates a best predicted result), with the computer, postoperative changes to the spine ([0186]: The above embodiments are not only applicable to knee implants, but are applicable to implants in other parts of the body, e.g., an acetabulum, a femoral head, a glenoid, a humeral head, an elbow joint, a wrist joint, an ankle joint, a spine, etc. Spinal implants are medical devices used to stabilize, strengthen, or correct the spine. After a spinal implants, a patient is able to straighten his/her back since the implants provide structural support to a weakened spine) of the target patient to determine a surgical plan for the patient based on the analysis of the three-dimensional model associated with the target patient ([0038]-[0047]: In various embodiments, the design, selection, modification, manufacturing and implantation of patient-adapted implant components can include various combinations of the following steps: (1) Collection of patient image data; (2) Segmentation, identification and/or classification/conversion of image data into anatomical data; (3) Modeling of anatomical data; ...) in view of the medical data associated with the reference patient ([0055]-[0056]: 0055] At various phases, the automated system may assess, compare and/or analyze one or more of the patient-specific measurements (which may include various combinations of such measurements) to information from a database of anatomical features of interest from other patients and/or population groups, …. Any parameter mentioned in the specification and in the various Tables throughout the specification including anatomic, biomechanical and kinematic parameters can be utilized, not only in the knee, but also in the hip, shoulder, ankle, elbow, wrist, spine and other joints. Such analysis may include modification of one or more patient-specific features and/or design criteria for the implant to account for any underlying deformity reflected in the patient-specific measurements. If desired, the comparison adapt and/or any modified data may be utilized directly to choose or design an appropriate implant to match the compared feature(s) (such as where an pre-existing surgical plan has been previously created for a patient having similar and/or identical relevant anatomical measurements), and a final verification operation may be accomplished to ensure the chosen implant is acceptable and appropriate to the original unmodified patient-specific measurements (i.e., to check that the chosen implant will ultimately "fit" the specific patient anatomy)).
Therefore it would have been obvious to a PHOSITA before the effective filing date to incorporate the teaching of Steines into that of Mueller in order to enable an automated system to utilize patient anatomical data in modeling and/or otherwise approximating anatomical features of interest for a given patient, and then utilize these models/approximations in various ways to derive and/or select an appropriate surgical plan and/or associated implant components as suggested by Steines ([0005]).
Regarding Claim 2, Steines further teaches or suggests determining parameters of a spinal device based on the predicted postoperative changes to the spine of the target patient ([0070]: In other embodiments, the software can automatically determine the initial best fit of the template model to the biological feature of interest or the image data. This can be achieved by finding the scaling, rotation and translation parameters that result in the closest fit of the template to the structure of interest, for example using a multidimensional optimization algorithm).
Regarding Claim 4, Steines further teaches or suggests wherein the spinal device is a screw, a rod, a cervical plate, a spine implant, an interbody device, or an artificial disc ([0012]: In various embodiments, the articular implant component (as well as any subsequent revision components) can be a knee joint implant component, a hip joint implant component, a shoulder joint implant component, or a spinal implant component. A skilled person would have known that a screw, a rod, a cervical plate, a spine implant, an interbody device, or an artificial disc is a common spinal device in spine surgery).
Regarding Claim 5, Steines further teaches or suggests generating instructions to construct the spinal device with a three-dimensional printer based on the parameters of the spinal device (p.44 Table 9 See 3DP).
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Regarding Claim 6, Steines further teaches or suggests comprising evaluating, with the computer, spines of a plurality of different reference patients for similarities to the spine of the target patient ([0012]: In various embodiments, the articular implant component (as well as any subsequent revision components) can be a knee joint implant component, a hip joint implant component, a shoulder joint implant component, or a spinal implant component. [0056]: If desired, the comparison adapt and/or any modified data may be utilized directly to choose or design an appropriate implant to match the compared feature(s) (such as where an pre-existing surgical plan has been previously created for a patient having similar and/or identical relevant anatomical measurements), and a final verification operation may be accomplished to ensure the chosen implant is acceptable and appropriate to the original unmodified patient-specific measurements (i.e., to check that the chosen implant will ultimately "fit" the specific patient anatomy)).
Regarding Claim 7, Mueller modified by Steines teaches or suggests wherein the medical data associated with the reference patient includes one or more of statistical data, electronic medical records, and image data (Mueller [0028]: the model may be generated from a population-based model, which is a model that is based on a statistical average of positions of discontinuities from scans on similar objects, e.g., objects having similar characteristics as the object to be scanned. Steines [0146]: In certain embodiments, a measure of bone preservation can include total volume of bone resected, volume of bone resected from one or more resection cuts, volume of bone resected to fit one or more implant component bone cuts, average thickness of bone resected, average thickness of bone resected from one or more resection cuts, average thickness of bone resected to fit one or more implant component bone cuts, maximum thickness of bone resected, maximum thickness of bone resected from one or more resection cuts, maximum thickness of bone resected to fit one or more implant component bone cuts. [0055]: At various phases, the automated system may assess, compare and/or analyze one or more of the patient-specific measurements (which may include various combinations of such measurements) to information from a database of anatomical features of interest from other patients and/or population groups, which could also include databases of (a) "normalized" patient models, (b) healthy individuals, (c) gender, age, race or activity matched individuals, (d) unhealthy patient individuals, (e) records of previous surgeries of other individuals. [0064]: In certain embodiments, individual images of a patient's biological structure can be segmented individually and then, in a later step, the segmentation data from each image can be combined).
Regarding Claim 8, Steines teaches or suggests analyzing, with the computer, medical data associated with the target patient; and comparing medical data of the target patient with medical data of a plurality of different reference patients ([0055]: At various phases, the automated system may assess, compare and/or analyze one or more of the patient-specific measurements (which may include various combinations of such measurements) to information from a database of anatomical features of interest from other patients and/or population groups, which could also include databases of (a) "normalized" patient models, (b) healthy individuals, (c) gender, age, race or activity matched individuals, (d) unhealthy patient individuals, (e) records of previous surgeries of other individuals, and/or (f) any other anatomical database).
Claim(s) 13-15, 17 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller (US 2011/0019791 A1) in view of Steines et al. (US 20140228860 A1) as applied to Claim 1 above, and further in view of Kadoury et al., ("Personalized X-Ray 3-D Reconstruction of the Scoliotic Spine From Hybrid Statistical and Image-Based Models," IEEE Trans Medical Imaging, 28(9):1422-1435, 2009).
Regarding Claim 13, Mueller modified by Steines fails to explicitly disclose obtaining a first X-ray image of at least a portion of a spine of the target patient in a first plane; obtaining a second X-ray image of the at least a portion of the spine of the target patient in a second plane; and drawing a line through vertebral bodies of the at least a portion of the spine of the target patient in the first X-ray image and in the second X-ray image, and wherein constructing the three-dimensional model associated with the target patient is further based on the lines drawn on the first and second X-ray images.
However Kadoury discloses
obtaining a first X-ray image of at least a portion of a spine of the target patient in a first plane; obtaining a second X-ray image of the at least a portion of the spine of the target patient in a second plane; and drawing a line through vertebral bodies of the at least a portion of the spine of the target patient in the first X-ray image and in the second X-ray image, and wherein constructing the three-dimensional model associated with the target patient is further based on the lines drawn on the first and second X-ray images (p.1425 left column Section B. Spine Centerline Extraction).
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Therefore it would have been obvious to a PHOSITA before the effective filing date to incorporate the teaching of Kadoury into that of Mueller as modified in order to perform 3D evaluation of an immediate effect of a treatment as suggested by Kadoury (p.1422 right column Section 1. Introduction lines 6-7).
Regarding Claim 14, Kadoury discloses wherein the first plane is a coronal plane and the second plane is a sagittal plane images (p.1425 left column Section B. Spine Centerline Extraction).
Regarding Claim 15, Kadoury further discloses obtaining a third X-ray image of the at least a portion of the spine of the target patient in an axial plane; and wherein constructing the three-dimensional model associated with the target patient includes constructing the three-dimensional model associated with the target patient based on the lines drawn on the first, second, and third X-ray images (p.1426 right column3rd paragraph lines 1-6: While Fourier descriptors were previously used to describe the shape of normal 2-D vertebrae on a single X-ray image [19], therefore exhibiting no type of rotational components, this study handles vertebrae with severe deformities, exhibiting axial, frontal, and sagittal rotations which must be detected on both conventional X-ray images. Also see p.1430 Fig.7: notice Axial view shown in (b). Note although Fig.7 is MRI image, it would have been obvious to a PHOSITA before the effective filing date of the claimed invention to have recognized that the principal to generate a 3D model based on 2D images are similar for both x-ray CT or MRI images).
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Regarding Claim 17, Kadoury discloses calibrating the first X-ray image and the second X-ray image (p.1425 left column second paragraph lines 1-4: The biplanar X-ray images are subsequently calibrated with a self-calibration approach which automatically optimizes in a nonlinear fashion the geometrical parameters of the radiographic setup [42]).
Regarding Claim 20, Kadoury teaches or suggests combining the first X-ray image and the second X-ray image to construct the three-dimensional model associated with the target patient (p.1424 left column 3rd paragraph: The objective of this work is to accomplish the personalized 3-D reconstruction of the scoliotic spine by using the 3-D centerline to predict an initial shape which reproduces the pathological deformations observed on a representative scoliotic spine database. A novel segmentation method which takes into account the local appearance of scoliotic vertebrae (rotation, wedging), as well as the image content is then proposed to isolate and personalize the 3-D bone structures from a biplanar X-ray system).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller (US 2011/0019791 A1) in view of Steines et al. (US 20140228860 A1) in view of Kadoury et al., ("Personalized X-Ray 3-D Reconstruction of the Scoliotic Spine From Hybrid Statistical and Image-Based Models," IEEE Trans Medical Imaging, 28(9):1422-1435, 2009) as applied to Claim 13 above, and further in view of Kyphosis (downloaded @https://web.archive.org/web/20170319084746/https://orthochiro.ca/en/kyphosis.php, March 19 2017).
Regarding Claim 16, Mueller modified by Steines and Kadoury discloses identifying a line on the first X-ray image; and identifying a line on the second X-ray image (Kadouryp.1425leleft column Section B. Spine Centerline Extraction
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).
But Mueller as modified fails to disclose wherein the line on the first X-ray image and the line on the second X-ray image are colored lines and identifying the colored lines includes quantifying the color of the colored lines and identifying differences in characteristics of the colored lines.
However color coding spine had been a known practice before the effective filing date of the claimed invention. Kyphosis uses green color to represent an ideal spinal column and red color to represent hyperkyphosis.
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Therefore it would have been obvious to a PHOSITA before the effective filing date to incorporate the teaching of Kyphosis into that of Mueller as modified and to include the limitation of wherein the line on the first X-ray image and the line on the second X-ray image are colored lines and identifying the colored lines includes quantifying the color of the colored lines and identifying differences in characteristics of the colored lines in order to distinguish normal and kyphosis spine via color.
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller (US 2011/0019791 A1) in view of Steines et al. (US 20140228860 A1) in view of Kadoury et al., ("Personalized X-Ray 3-D Reconstruction of the Scoliotic Spine From Hybrid Statistical and Image-Based Models," IEEE Trans Medical Imaging, 28(9):1422-1435, 2009) as applied to Claim 13 above, and further in view of Amiri (US 2019/0320995 A1).
Regarding Claim 18, Mueller as modified fails to explicitly disclose compensating for differences in magnification between the first X-ray image and the second X-ray image.
However Amiri teaches Any X-ray image taken by the system may be transformed into one or more of the anatomical planes based on known image parameters and position of the anatomical plane of interest relative to the pose of the X-ray machine when the X-ray image was acquired (Step 5. in FIG. 1B). The transformation may involve translation, scaling and/or warping of the X-ray image ([0116]). Therefore it would have been obvious to a PHOSITA before the effective filing date to incorporate the teaching of Amiri into that of Mueller as modified and to include the limitation of compensating for differences in magnification between the first X-ray image and the second X-ray image in order to account for the pelvic tilt of the patient on the surgical table as suggested by Amiri ([0174]).
Regarding Claim 19, Amiri further teaches or suggests scaling the first and second X-ray images ([0116]: Any X-ray image taken by the system may be transformed into one or more of the anatomical planes based on known image parameters and position of the anatomical plane of interest relative to the pose of the X-ray machine when the X-ray image was acquired (Step 5. in FIG. 1B). The transformation may involve translation, scaling and/or warping of the X-ray image). The same reason to combine as that of Claim 18 is applied.
Allowable Subject Matter
Claims 3 and 9-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Prior art, either individually or in combination, fails to disclose or render obviousness the limitation of wherein the parameters of the spinal device are determined based on predicted postoperative changes which include: a first predicted postoperative change to movement of the spine of the target patient at a first time, and one or more additional predicted postoperative changes at times subsequent to the first time as claimed in dependent claim 3; wherein acquiring the medical data associated with the reference patient different from the target patient includes obtaining a plurality of different four-dimensional models of spines; and further comprising: generating a respective score for each of the plurality of different four-dimensional models of spines based on a comparison to the three-dimensional model associated with the target patient; and comparing the respective scores against a predetermined score to predict movement of the spine of the target patient as claimed in dependent Claim 9 and wherein acquiring the medical data associated with the reference patient different from the target patient includes obtaining at least one four-dimensional model for a similar spine of the reference patient; and further comprising: analyzing the three-dimensional model associated with the target patient based on the at least one four-dimensional model for the similar spine of the reference patient to predict movement of the spine of the target patient, and determining parameters of a spinal device based on the predicted movement of the spine of the target patient as claimed in dependent Claim 11. The closest prior art, Steines, discloses determining parameters of a spinal device based on predicted postoperative changes. However, Steines fails to disclose above cited detailed limitations. Claims 10 and 12 are objected due to their dependency on Claim 9 and 11.
Conclusion
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/YINGCHUN HE/Primary Examiner, Art Unit 2613