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 .
Specification
The lengthy specification has not been checked to the extent necessary to
determine the presence of all possible minor errors. Applicant's cooperation is
requested in correcting any errors of which applicant may become aware in the
specification.
Examiner Notes
Examiner cites particular columns, paragraphs, figures and line numbers in the references as applied to the claims below for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in their entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner. The entire reference is considered to provide disclosure relating to the claimed invention. The claims & only the claims form the metes & bounds of the invention. Office personnel are to give the claims their broadest reasonable interpretation in light of the supporting disclosure. Unclaimed limitations appearing in the specification are not read into the claim. Prior art was referenced using terminology familiar to one of ordinary skill in the art. Such an approach is broad in concept and can be either explicit or implicit in meaning. Examiner's Notes are provided with the cited references to assist the applicant to better understand how the examiner interprets the applied prior art. Such comments are entirely consistent with the intent & spirit of compact prosecution.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2, 8 and 13-14 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites “, wherein the data includes information associated with patients of different sizes”, claim 8 recites “wherein the statistical relationship includes size related, …” and claim 13 recites “wherein the matrix decomposition includes the data having geometry data, size information and/or an associated height information.” It is unclear what size is referring to (e.g. implant size, patient body size, organ size, etc).
Sinceclaim 14 is depending on claim 13, the dependent claims recite the indefinite scope in claim 13.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1, 2, 4-6, 10, 17-20, 22 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chaoui (US 2020/0246077 A1).
1. (Original) A method including: Chaoui discloses using a model to assist in defining one or more outer surfaces of a medical implant, the model being based on a statistical analysis of data, associated with an intended location of a medical implant, from multiple patients; and
Chaoui: [0145] “As part of the pre-operative analysis, and design and production of a patient-specific glenoid implant, a statistical shape model can be used, including the use of a statistical appearance shape model, and/or parametric or non-parametric modeling. FIG. 17 is a schematic illustration of a scapula bone and glenoid surface depicted with defined zones based on statistical shape analysis. The multi-curvature glenoid backside can be analyzed according to statistical shape analysis. Based on the analysis of 70 pathologic scapula, principal statistical modes of the glenoid shape have been defined as depicted in FIG. 17.. …”
Chaoui: [0125] “In some embodiments, a variable augmented glenoid implant or prosthesis is provided, wherein the variable augmentation is defined by one or more of the following: the depth of augmentation, the size of augmentation, the shape of the augmentation and/or the radial position of augmentation. … The shape of the augmentation can for example comprise a plate-like shape, sphere-like shape (fixed curvature, ellipsoid-like structure), cone like shape, a pyramid like shape or the like. The positioning of the augmentation on the second surface or back side of the glenoid can also vary, and can be located on the posterior and/or anterior side of the second surface, and/or at a superior and/or inferior location of the second surface of the glenoid implant. In some embodiments, the augmentation can be patient specific and/or patient tailored. …”
Chaoui discloses producing the medical implant based on the one or more outer surfaces.
Chaoui: [0145] “As part of the pre-operative analysis, and design and production of a patient-specific glenoid implant, a statistical shape model can be used, including the use of a statistical appearance shape model, and/or parametric or non-parametric modeling.
See [0148] for production tool.
2. (Original) The method of claim 1, Chaoui discloses wherein the data includes information associated with patients of different sizes.
Chaoui: [0145] “… Based on the analysis of 70 pathologic scapula, principal statistical modes of the glenoid shape have been defined as depicted in FIG. 17. Based on these modes multiple backside zones with multiple curvatures can be defined. For example, a glenoid 710 on a scapula 700 as depicted in FIG. 17 can comprise a superior/posterior zone 722 that comprises about 13% of the glenoid surface, and having a radius of curvature (RoC) of about 22 mm. A superior/anterior zone 724 can comprise about 17% of the glenoid surface, and comprise a RoC of about 39 mm. An inferior/posterior zone 726 can comprise about 43% of the glenoid surface, and comprise a RoC of about 21 mm. An inferior/anterior zone 728 can comprise about 27% of the glenoid surface, and comprise a RoC of about 21 mm.”
4. (Previously Presented) The method of claim 1, Chaoui discloses wherein the step of using the model includes: retrieving a statistical shape based on the statistical analysis of the data; and defining the one or more outer surfaces of a medical implant based on the statistical shape.
Chaoui: [0145] “As part of the pre-operative analysis, and design and production of a patient-specific glenoid implant, a statistical shape model can be used, including the use of a statistical appearance shape model, and/or parametric or non-parametric modeling. FIG. 17 is a schematic illustration of a scapula bone and glenoid surface depicted with defined zones based on statistical shape analysis. The multi-curvature glenoid backside can be analyzed according to statistical shape analysis. Based on the analysis of 70 pathologic scapula, principal statistical modes of the glenoid shape have been defined as depicted in FIG. 17. Based on these modes multiple backside zones with multiple curvatures can be defined. For example, a glenoid 710 on a scapula 700 as depicted in FIG. 17 can comprise a superior/posterior zone 722 that comprises about 13% of the glenoid surface, and having a radius of curvature (RoC) of about 22 mm. A superior/anterior zone 724 can comprise about 17% of the glenoid surface, and comprise a RoC of about 39 mm. An inferior/posterior zone 726 can comprise about 43% of the glenoid surface, and comprise a RoC of about 21 mm. An inferior/anterior zone 728 can comprise about 27% of the glenoid surface, and comprise a RoC of about 21 mm.”
5. (Original) The method of claim 4, Chaoui discloses wherein the statistical shape includes at least two surfaces and a space therebetween assists in defining the one or more surfaces of the medical implant.
Chaoui: [0146] “… In FIG. 18A glenoid implant 750 with no back-side augmentation is secured to glenoid 704 by, at least in part, augmentation 752, wherein a gap 754 exists between the back side of glenoid implant 750 and face 706 of glenoid bone 704. Alternatively, in FIG. 18B a glenoid implant 750 with back-side augmentation 756 is seated or affixed to glenoid 704, wherein augmentation 756 fills, or at least substantially fills, the gap such that the back-side of glenoid implant 750 more closely matches, and/or securely fits against, the face 706 of the native glenoid 704. Such augmentation can be configured to be patient-specific such that it matches the unique structure and/or surface character of a native glenoid of a patient to be treated.”
6. (Previously Presented) The method of claim 1, Chaoui discloses wherein the step of using the model includes using a statistical relationship established from the data to retrieve a statistical shape associated with the intended location of the medical implant.
Chaoui: [0125] “In some embodiments, a variable augmented glenoid implant or prosthesis is provided, wherein the variable augmentation is defined by one or more of the following: the depth of augmentation, the size of augmentation, the shape of the augmentation and/or the radial position of augmentation. By way of example and not limitation, the depth of the augmentation can range from about 2 mm to about 4 mm. Further, the augmentation can be small in size with respect to the size of the glenoid implant, e.g., can cover about 5%, 10%, 15%, 20%, 30%, 40%, 50%, or more of the back side of the glenoid implant, or can be large in size with respect to the size of the glenoid implant, e.g., can cover about 50%, 60%, 70%, 80%, 90%, 95% or greater of the back side of the glenoid implant. The shape of the augmentation can for example comprise a plate-like shape, sphere-like shape (fixed curvature, ellipsoid-like structure), cone like shape, a pyramid like shape or the like. The positioning of the augmentation on the second surface or back side of the glenoid can also vary, and can be located on the posterior and/or anterior side of the second surface, and/or at a superior and/or inferior location of the second surface of the glenoid implant. In some embodiments, the augmentation can be patient specific and/or patient tailored. In some aspects, the patient “specific” augmentation is generated by a geometric representation that best fits the joint surface, and does not consider that the joint surface necessarily needs to be altered in any way prior to implantation of the implant. In the case of a patient “tailored”, the best fit implant is chosen, with a consideration for minimization of bone surface alteration to achieve minimally acceptable or optimal interface characteristics between the surface of the scapula bone and the implant. In some embodiments, the geometric representation can be plate (best fit plane), and/or spherical (best-fit-sphere), and/or ellipsoid (best-fit-ellipsoid). The radius of curvature could vary from ∞ to 10.”
10. (Previously Presented) The method of claim 1, Chaoui discloses wherein the statistical analysis of the data is in more than two dimensions.
Chaoui: [0128-0132] “…The dimensions of the fixation elements can in some embodiments be patient tailored and their dimensions can be defined using correspondence matrix between a three dimensional (3D) bony structure of the patient and a statistical shape based atlas according to the following steps: 1. developing a registration between patient bone and statistical shape model of the bone of interest;2. extract the principle modes representing the patient bone; 3. define the fixation configuration (position and dimensions) according to the corresponding modes; and 4. apply collision detection to confirm the configuration of the bone fixation.”
17. (Previously Presented) The method of claim 1, Chaoui discloses wherein the statistical analysis includes creating an n-dimensional shape space.
Chaoui: [0128-0132] “…The dimensions of the fixation elements can in some embodiments be patient tailored and their dimensions can be defined using correspondence matrix between a three dimensional (3D) bony structure of the patient and a statistical shape based atlas according to the following steps: 1. developing a registration between patient bone and statistical shape model of the bone of interest;2. extract the principle modes representing the patient bone; 3. define the fixation configuration (position and dimensions) according to the corresponding modes; and 4. apply collision detection to confirm the configuration of the bone fixation.”
18. (Previously Presented) The method of claim 1, Chaoui discloses wherein using the model includes determining a confidence interval of data within a defined criteria.
Chaoui: [0161] “As used herein, “significance” or “significant” relates to a statistical analysis of the probability that there is a non-random association between two or more entities. To determine whether or not a relationship is “significant” or has “significance”, statistical manipulations of the data can be performed to calculate a probability, expressed as a “p value”. Those p values that fall below a user-defined cutoff point are regarded as significant. In some embodiments, a p value less than or equal to 0.05, in some embodiments less than 0.01, in some embodiments less than 0.005, and in some embodiments less than 0.001, are regarded as significant. Accordingly, a p value greater than or equal to 0.05 is considered not significant.”
19. (Previously Presented) The method of claim 18, Chaoui discloses wherein the defined criteria is defined in a manner to create a suitable cohort of medical implants.
Chaoui [0107] “In some embodiments, the above methods of designing and/or creating a glenoid implant, shoulder surgery guide, including a glenoid placement guide, based on pre-operative planning can further comprise one or more optimization steps. Such optimization steps can comprise the identification of procedural risks based on measurements of one or more of a plurality of factors. Such factors can in some embodiments comprise whether the glenoid face coverage is maximized (e.g. about 0 to about 2 mm), the overhang of the glenoid face is minimized (e.g. about 0 to about 3 mm), and/or the bone removal on the glenoid face is minimized, such as for example less than about 2 mm of depth. Continuing, in some embodiments such optimization factors can comprise whether the glenoid retroversion is less than about 5 degrees to about 10 degrees, the seating of the glenoid implant is greater than about 80%, i.e. about 80% of the back side of the glenoid implant is supported by or touching bone, whether there is minimized penetration of the glenoid cortical wall anteriorily (e.g. about 0 mm to about 3 mm), and/or the depth of any glenoid implant augment feature is as minimal as possible. …”
20. (Previously Presented) The method of claim 1, Chaoui discloses wherein the method further comprises including one or more device parameters to assist in defining the one or more outer surfaces of the medical implant.
Chaoui [0107] “In some embodiments, the above methods of designing and/or creating a glenoid implant, shoulder surgery guide, including a glenoid placement guide, based on pre-operative planning can further comprise one or more optimization steps. Such optimization steps can comprise the identification of procedural risks based on measurements of one or more of a plurality of factors. Such factors can in some embodiments comprise whether the glenoid face coverage is maximized (e.g. about 0 to about 2 mm), the overhang of the glenoid face is minimized (e.g. about 0 to about 3 mm), and/or the bone removal on the glenoid face is minimized, such as for example less than about 2 mm of depth. Continuing, in some embodiments such optimization factors can comprise whether the glenoid retroversion is less than about 5 degrees to about 10 degrees, the seating of the glenoid implant is greater than about 80%, i.e. about 80% of the back side of the glenoid implant is supported by or touching bone, whether there is minimized penetration of the glenoid cortical wall anteriorily (e.g. about 0 mm to about 3 mm), and/or the depth of any glenoid implant augment feature is as minimal as possible. …”
22. (Previously Presented) The method of claim 20, Chaoui discloses wherein the one or more device parameters are based on one or more predetermined parameters set by an external specification.
Chaoui [0106] In some embodiments, the disclosed pre-operative planning methods can further comprise identifying a prosthetic shoulder implant, and/or designing a patient-specific augmented glenoid implant, and/or identifying a placement position for the prosthetic shoulder implant. The design and/or identification of a prosthetic shoulder implant and placement position takes into consideration at least one of the factors selected from the group consisting of adjustments in glenoid implant size, augmentation depth, augment position, positioning in six degrees of freedom, fixation type, fixation size, reaming depth, reaming diameter, reaming angle, and/or a combination thereof. The above method can further comprise a step of recommending implants and placement positions, with recommended adjustments in humerus stem size, length, head diameter, head height, head offset and rotation (axial). A prosthetic shoulder implant can in some embodiments comprise a glenoid implant.”
23. (Original) The method of claim 22, Chaoui discloses wherein the external specification includes: a surgeon specification; and/or published specifications in scientific literature.
Chaoui [0080] “The above methods can further comprise a step of recommending implants and placement positions, with recommended adjustments in glenoid implant size, augmentation depth, augment position, positioning in six degrees of freedom, fixation type, fixation size, reaming depth, reaming diameter, and reaming angle(s), seating ratio, wherein the reaming angles can comprise retroversion and inclination. The above method can further comprise a step of recommending implants and placement positions based on the reaming quantity, such as for example the quantity of removed cortical bone based on the Hounsfield units extracted directly from CT images. The above method can further comprise a step of recommending implants and placement positions, with recommended adjustments in humerus stem size, length, head diameter, head height, head offset and rotation (axial).”
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.
Claim(s) 7, 11, 13-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chaoui (US 2020/0246077 A1) in view of Kozic et al (NPL: Optimisation of orthopaedic implant design using statistical shape space analysis based on level sets, 2010), hereinafter Kozic.
7. (Original) The method of claim 6, Chaoui does not appear to explicitly disclose wherein the statistical relationship includes an equation relating to a line of best fit through the data.
However, Kozic discloses wherein the statistical relationship includes an equation relating to a line of best fit through the data.
(page 270) section 4.2
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Chaoui and Kozic are analogous art because they are from the “same field of endeavor” implant design analysis.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of Chaoui and Kozic before him or her, to modify the method of Chaoui to include the model of Kozic because this combination improves the design of the implant.
The suggestion/motivation for doing so would have been Kozic (Abstract) “Based on our framework, we can virtually fit a proposed implant design to samples drawn from the statistical model, and assess which range of the population is suitable for the implant. The method highlights which patterns of bone variability are more important for implant fitting, allowing and easing implant design improvements, as to fit a maximum of the target population.”
Therefore, it would have been obvious to combine Chaoui and Kozic to obtain the invention as specified in the instant claim(s).
11. (Previously Presented) The method of claim 1, Chaoui does not appear to explicitly disclose wherein a matrix decomposition is performed on the data as part of developing the model.
However, Kozic discloses wherein a matrix decomposition is performed on the data as part of developing the model (page 266-267) section 2.2 Principal component analysis.
Chaoui and Kozic are analogous art because they are from the “same field of endeavor” implant design analysis.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of Chaoui and Kozic before him or her, to modify the method of Chaoui to include the model of Kozic because this combination improves the design of the implant.
The suggestion/motivation for doing so would have been Kozic (Abstract) “Based on our framework, we can virtually fit a proposed implant design to samples drawn from the statistical model, and assess which range of the population is suitable for the implant. The method highlights which patterns of bone variability are more important for implant fitting, allowing and easing implant design improvements, as to fit a maximum of the target population.”
Therefore, it would have been obvious to combine Chaoui and Kozic to obtain the invention as specified in the instant claim(s).
13. (Previously Presented) The method of claim 11, wherein the matrix decomposition includes the data having geometry data, size information and/or an associated height information.
Chaoui: [0098] “In some embodiments, a pre-operative planning method for the humerus can comprise a step 202, as depicted in FIG. 2B, where the height h of humeral head 60 of humerus 62 can be measured. In some embodiments, this analysis can be accomplished virtually based on images taken from a subject or patient prior to surgery. By measuring height h of humeral head 60, data and information can be collected that informs the selection of a humeral head implant, and/or supports the design and production of a patient-specific augmented glenoid implant, and/or supports the creation of a shoulder surgery guide device specific to the patient or subject to be treated.”
14. (Previously Presented) The method of claim 13, Kozic discloses wherein an eigen decomposition is performed on the matrix decomposition which forms the bases of a principal components analysis (page 266-267) section 2.2 Principal component analysis.
15. (Previously Presented) The method of claim 1, Chaoui does not appear to explicitly disclose wherein the dimensionality of the data is reduced into a smaller subset.
However, Kozic discloses wherein the dimensionality of the data is reduced into a smaller subset (page 266-267) section 2.2 Principal component analysis.
“The resulting image vectors described in Eq. (2) are high dimensional data, because we consider every point coordinate in the region of interest. To reduce the dimensionality of the data and obtain a compact parametric description, we apply principal component analysis. PCA is a multivariate factor analysis technique aiming at finding a low-dimensional manifold in the space of the data, such that the distance between the data and its projection on the manifold is small (Bishop, 1995). PCA is the best, in the mean-square error sense, linear dimension reduction technique.”
Chaoui and Kozic are analogous art because they are from the “same field of endeavor” implant design analysis.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of Chaoui and Kozic before him or her, to modify the method of Chaoui to include the model of Kozic because this combination improves the design of the implant.
The suggestion/motivation for doing so would have been Kozic (Abstract) “Based on our framework, we can virtually fit a proposed implant design to samples drawn from the statistical model, and assess which range of the population is suitable for the implant. The method highlights which patterns of bone variability are more important for implant fitting, allowing and easing implant design improvements, as to fit a maximum of the target population.”
Therefore, it would have been obvious to combine Chaoui and Kozic to obtain the invention as specified in the instant claim(s).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chaoui (US 2020/0246077 A1) in view of Landon et al (US 20230019873 A1), hereinafter Landon.
8. (Previously Presented) The method of claim 6, Chaoui does not appear to explicitly disclose wherein the statistical relationship includes size related, including at least one of isometric or allometric, scaling.
However, Landon discloses wherein the statistical relationship includes size related, including at least one of isometric or allometric, scaling on [0219] “In a further embodiment, the 3D bone model may be based on statistical shapes (i.e. a statistical shape model). In addition to scaling or otherwise adjusting the 3D bone model as a whole, individual statistical shapes may be scaled or adjusted in order to modify a discrete portion or region of the 3D bone model to better match the 2D image 1405. For example, in some embodiments, the size of a specific condyle of the 2D image may not match that of the 3D bone model, while other features of the bone are matched to a high degree of accuracy. In this case, one or more individual statistical shapes of the 3D bone model corresponding to the condyle may be scaled as a whole to better match the condyle of the 2D image. In another embodiment, a deformity may be misrepresented or not represented at all by the selected 3D bone model (e.g., the library may contain little data representing a rare deformity). In such a case, one or more individual statistical shape of the 3D bone model corresponding to a region including the deformity may be scaled and/or adjusted to better represent the deformity and better match the 2D image.”
Chaoui and Landon are analogous art because they are from the “same field of endeavor” implant design analysis.
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art, having the teachings of Chaoui and Landon before him or her, to modify the method of Chaoui to include the model of Landon because this combination improves the design of the implant.
The suggestion/motivation for doing so would have been Landon [0219] “In such a case, one or more individual statistical shape of the 3D bone model corresponding to a region including the deformity may be scaled and/or adjusted to better represent the deformity and better match the 2D image.”
Therefore, it would have been obvious to combine Chaoui and Landon to obtain the invention as specified in the instant claim(s).
Conclusion
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/CHUEN-MEEI GAN/ Primary Examiner, Art Unit 2189
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