DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-20 are currently pending in U.S. Patent Application No. 18/441,359 and an Office action on the merits follows.
Duplicate Claims - Warning
Applicant is advised that should claim 15 be found allowable, claim 14 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). For the claims in question, a Warning is more appropriate as compared to a Duplicate Claim Objection since the claim(s) are not in condition for allowance. Claim(s) 15 and 14 both reference/incorporate the method of claim 1, but are directed to “a non-transitory computer-readable storage medium” and “a non-transitory computer program product” respectively. Applicant’s specification at [0044-0045] of the corresponding PGPUB (US 2024/0281964 A1) appear(s) to disclose transitory/non-statutory (at step 1) program product embodiments, namely a program per se optionally comprising additional ‘component(s)’ that may themselves be software – however these embodiments are excluded by means of the modifying language ‘non-transitory’. [0046] discloses that the ‘product’ may comprise a ‘storage medium’, however it is not clear that any additional structure is necessarily required for the case of claim 14 as distinguished from 15, under interpretation of each term as required by MPEP 2173.01 and 2111. The two claims in question are interpreted as being substantial duplicates accordingly.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception, in particular an Abstract Idea falling under one or more of the enumerated groupings comprising (a) mathematical concepts category/grouping (mathematical relationships, formulas or equations, and/or calculations), and/or (c) the mental processes grouping (acts performable in the human mind including an observation, evaluation), not ‘integrated into a practical application’ at Prong Two of Step 2A and without ‘significantly more’ at Step 2B.
Step 1: The claim(s) in question are directed to a computer implemented method for calculating vertebral data (e.g. comprising one or more rotation angles). (Step 1: Yes).
Step 2A, Prong One: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. As explained in MPEP 2106.04, subsection II, a claim “recites” a judicial exception when the judicial exception is “set forth” or “described” in the claim. Representative claim 1 recites – “calculating a representation of the set of vertebrae based on the imaging data” and “calculating the vertebral data based on the representation of the set of vertebrae”, individually and collectively falling under the mathematical concepts Abstract Idea grouping. Both of the limitations in question may also fall under the mental processes Abstract Idea grouping, as a person/clinician may visually/mentally evaluate e.g. a frontal/ coronal view of patient anatomy and mentally decide/manually place landmarks/ keypoints for various vertebrae (thereby calculating a representation), and e.g. calculate a Cobb angle on the basis of end vertebrae as decided by the clinician based on respective rotations. Manually performed calculations that read on the limitations as recited, also appear suggested as conventionally practiced in the art in view of e.g. [0144] of Forsberg (US 2014/0323845 A1). As the 2024 PEG Examples 47-49 make clear, a Prong One analysis is not limited to a single Abstract Idea grouping/category since both of the groupings identified above fall under the same exception – the Abstract Idea exception. The July 17, 2024 PEG identifies various process steps identified as being drawn to the mathematical concepts Abstract Idea grouping – e.g. Example 47 claim 2 step(s) (b) (at page 7 describing the recited ‘discretizing’ as encompassing a mathematical concept e.g. rounding data values (that may also be performed mentally)) and (c) (interpreted so as to include mathematical calculations such as performing backpropagation and gradient descent algorithm(s)), in addition to Example 48 claim(s) 1 and 2 steps (b) (a ‘converting’ involving a mathematical operation using an STFT), (c) (determining (‘using’ a DNN) an ‘embedding’ on the basis of an explicitly recited formula), and (e) (‘applying binary masks’), and Example 48 claim 3 step(s) (c) (clustering using a k-means clustering algorithm) and (d) (binary masking clusters) - (see e.g. page 23 of the PEG – available https://www.uspto.gov/sites/default/files/documents/2024-AI-SMEUpdateExamples47-49.pdf ). MPEP 2106.04(a)(2)(C):
A mathematical calculation is a mathematical operation (such as multiplication) or an act of calculating using mathematical methods to determine a variable or number, e.g., performing an arithmetic operation such as exponentiation. There is no particular word or set of words that indicates a claim recites a mathematical calculation. That is, a claim does not have to recite the word "calculating" in order to be considered a mathematical calculation. For example, a step of "determining" a variable or number using mathematical methods or "performing" a mathematical operation may also be considered mathematical calculations when the broadest reasonable interpretation of the claim in light of the specification encompasses a mathematical calculation.
Dependent claims require at least these limitations of the abovementioned independent claim when analyzed at Prong One, and further introduce limitations also falling under the math concepts/operations grouping (e.g. calculating vertebra rotation information) and/or mental processes grouping (e.g. a mentally performed image segmentation), and dependent claims are similarly analyzed at Prong One accordingly. The August 04, 2025 memo reinforces the need to distinguish between limitations that ‘recite’ vs. merely ‘involve’ an exception, while affirming those various analysis/Examples set forth in the 2024 PEG (https://www.uspto.gov/sites/default/files/documents/memo-101-20250804.pdf), and Examiner notes that the claim limitations identified above explicitly recite ‘calculating’ ‘vertebral data’ and ‘rotation information’ and as such fall under that definition of mathematical calculation(s)/ determinations as identified in MPEP 2106.04(a)(2)(C). (Step 2A, Prong One: Yes).
Step 2A, Prong Two: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. This evaluation is performed by (1) identifying whether there are any ‘additional elements’ recited in the claim beyond the judicial exception, and (2) evaluating those ‘additional elements’ individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. See MPEP 2106.04(d). While preemption is not a standalone test for eligibility, the Alice/Mayo two-part framework’s roots in preemption, as described in the MPEP require weighing ‘additional elements’, not in a vacuum, but with/in view of those portions of the claim falling under the exception (MPEP 2106.04(d)), when evaluating whether “meaningful limits” are imposed. Examiner notes for consideration at Prong Two of 2A that MPEP 2106.05(a), (b), (c), and (e) generally concern limitations that are indicative of integration, whereas 2106.05(f), (g), and (h) generally concern limitations that are not indicative of integration. As an additional note, ‘additional elements’ are generally limitations excluded from interpretation under the Abstract Idea groupings, and may comprise portions of limitations otherwise identified as falling under those Abstract Idea groupings of the 2019 PEG (e.g. any ‘determination’ that may be made mentally accompanied by the use of a neural network and/or generic computer hardware considered under the ‘apply it’ considerations of 2106.05(f)). Any ‘providing’/outputting broadly, and ‘collection’ of data (i.e. image acquisition(s)), be they images for training any learning model and/or data/images visually observable/ evaluated by a user/operator, also fail(s) to integrate at least in view of MPEP 2106.05(g) (extra-solution data gathering/output) and/or 2106.05(h) as ‘generally linking’ the exception to a field of use involving machine learning and/or imagery so acquired. For the case of claim 1, only that ‘receiving’ and ‘providing’ are ‘additional elements’ (if that ‘vertebral data’ as permissibly/broadly interpreted cannot be that provided by a clinician manually/verbally etc.,) that fail for integration in view of at least MPEP 2106.05(g). Examiner also pre-emptively notes with respect to 2106.05(a), that ‘functioning of a computer’ (see fact pattern of Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016)) does not constitute operations that a general purpose computer may be programmed/configured to perform, since functioning of a computer instead concerns functions integral to the way computers operate (e.g. memory/database read/write operations for the case of Enfish, and virus scanning for the case of Finjan). Additionally, any fact(s) regarding the ‘utility’ of the exception itself, e.g. a broad array of potential/ unclaimed ‘uses’ of e.g. a calculated Cobb angle (diagnosis, pre-operative surgical planning, etc.,), does not evidence integration into a practical application, as such uses, especially if not recited and even if recited broadly, do not contribute ‘beyond’ generally linking the exception to one or more fields of use (2106.05(h)). For the instant claim(s) in question, no ‘additional elements’ appear to explicitly/specifically capture/recite any disclosed improvement in technology (see MPEP 2106.05(a)) – particularly because the claim essentially rests with the calculation of vertebral data, and even if done novelly, such a calculation is not statutory subject matter and the improvement cannot be to the exception. With reference to MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981))
Even when viewed in combination, the ‘additional elements’ present do not integrate the recited judicial exception into a practical application (Step 2A, Prong Two: No), and the claims are directed to the judicial exception. (Revised Step 2A: Yes [Wingdings font/0xE0] Step 2B).
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to ‘significantly more’ than the recited exception, i.e., whether any ‘additional element’, or combination of additional elements, adds an inventive concept to the claim. The considerations of Step 2A Prong 2 and Step 2B overlap, but differ in that 2B also requires considering whether the claims feature any “specific limitation(s) other than what is well-understood, routine, conventional activity in the field” (WURC) (MPEP 2106.05(d)). Such a limitation if specifically recited however, must still be excluded from interpretation under any of the Abstract Idea groupings. Step 2B further requires a re-evaluation of any additional elements drawn to extra-solution activity in Step 2A (e.g. gathering imaging data) – however no limitations appear directed to any novel image collection per se. Limitations not indicative of an inventive concept/ ‘significantly more’ include those that are not specifically recited (instead recited at a high level of generality), those that are established as WURC, and/or those that are not ‘additional elements’ by nature of their analysis at Prong One (i.e. reciting the exception/calculation(s)). Reference may also be made to the 2024 PEG describing that an improvement/ inventive concept (for ‘significantly more’ determination(s)) cannot be to the judicial exception itself. (Step 2B: No).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
1. Claims 1-7 and 13-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Forsberg (US 2014/0323845 A1) (cited by Applicant).
As to claim 1, Forsberg discloses a computer-implemented method for providing vertebral data (Figs. 6, 7, 11, Fig 11 225 generating measurements of position, rotation and local deformity of each or selected vertebra using the transferred landmarks, 227, and 228 generating a plurality of graphs of T1-L5 curvature with the calculated measurements including.. θx, θy, θz, [0042-0043], etc.,), the computer-implemented method comprising:
receiving imaging data of an examination region, wherein the examination region includes a set of vertebrae from a vertebral column (Fig. 2A/5A patient data, Fig. 9 326, Fig. 11 205, [0008] “(b) obtaining 3-D patient image data of a spine of the patient; (c) extracting subvolumes of the 3-D patient image data associated with the spine, respective subvolumes each including at least one vertebra in full and at least one neighboring vertebrae structure or a portion thereof”, (ii) and (iii) of [0031], [0012], [0172] “The data 356 may include (near real time or archived or stored) digital image data sets 326 that provides stacks of image data including meta data regarding, for example, voxel size (DICOM data to correlate the image data to respective patients)”, etc.,);
calculating a representation of the set of vertebrae based on the imaging data (Fig. 2C model/representation post transfer of landmarks to patient data, Fig. 11 210-215, [0008] “(e) electronically registering, subvolume by subvolume, the 3-D model and the 3-D patient image data of the spine; then (f) electronically transferring the landmarks from the model to the 3-D patient image”, [0035], etc.,);
calculating the vertebral data based on the representation of the set of vertebrae (Fig. 11 225-228, [0008] “(g) electronically calculating measurements for one or more vertebrae, including at least one of the following: (i) position in X, Y and Z coordinates (mm), (ii) rotation θx, θy, θz, in degrees, and (iii) a local deformity (lateral wedge) value (mm) using the transferred landmarks”, [0042-0043], [0117], etc.,); and
providing the vertebral data ([0013] “The method can include electronically generating a plurality of graphs of T1-L5 curvature using the calculated measurements, including graphs of displacements (mm) x vs. z and y vs. z, a graph of the calculated local deformity (mm) vs. z and at least one graph of a respective rotational measurement of one or more of rotation θx, θy, θz, in degrees vs. z”, [0019] “wherein … θz corresponds to axial vertebral rotation, θy corresponds to frontal rotation and θx corresponds to sagittal rotation”, [0037], etc.,).
As to claim 2, Forsberg discloses the method of claim 1.
Forsberg further discloses the method wherein the representation of the set of vertebrae includes, for each respective vertebra in the set of vertebrae, at least one of (i) at least two points of a top side of the respective vertebra or (ii) at least two points of a bottom side of the respective vertebra (Figs 3B-3C and 4B, landmarks 7, 9, 10, 13 and 14 on top side of vertebra and landmarks 8, 11, 12, 15 and 16 on bottom, 7-8 common to (B) sagittal and (C) frontal views, [0116], [0119], etc.,).
As to claim 3, Forsberg discloses the method of claim 1.
Forsberg further discloses the method wherein the representation of the set of vertebrae is calculated based on the imaging data by applying a segmentation algorithm to the imaging data (pre-processing prior to/facilitating registration step, wherein the subvolumes are extracted (e) of [0008], [0012] “Before the registration, the method may optionally include pre-processing the patient image data to electronically estimate an initial position and rotation of each vertebrae of the patient image data”, [0064] “The upper and lower left panels of FIG.2B illustrate a subvolume extraction of the patient data and spine model for a respective vertebra according to embodiments of the present invention”, [0125] “The data can optionally also be further pre-processed in order in increase the borders of adjacent vertebrae by applying a threshold at 100 Hounsfield units, to remove the influence of Soft tissues during the registration process, and by applying a valley-emphasis. See, e.g., Kim, Y. and Kim, D., 2009. A fully automatic vertebra segmentation method using 3d deformable fences, Computerized Medical Imaging and Graphics 33(5), 343-352, the contents of which are hereby incorporated by reference as recited in full herein”, [0143] “The manual hand segmentations were compared with the segmentations obtained from the deformed models using a Point-to-Surface error (PSE). The PSE is defined as the smallest distance between a node on the deformed model and the closest surface of the manual segmentation. The meshes defining the vertebrae of the deformed model and the handsegmented vertebrae were acquired from their corresponding binary volumes using iso2 mesh (Fang, Q. and Boas, D. A.: 2009, Tetrahedral mesh generation from volumetric binary and grayscale images, Biomedical Imaging. From Nano to Macro, 2009. ISBI'09. IEEE International Symposium on, IEEE, pp. 1142-1145)”, etc.,).
As to claim 4, Forsberg discloses the method of claim 1.
Forsberg further discloses the method wherein for each respective vertebra in the set of vertebrae, rotation information relating to a rotation of the respective vertebra is calculated based on the representation of the set of vertebrae (see mapping above for the case of claim 1, Fig. 11 225-228, [0008] “(g) electronically calculating measurements for one or more vertebrae, including at least one of the following: (i) position in X, Y and Z coordinates (mm), (ii) rotation θx, θy, θz, in degrees, and (iii) a local deformity (lateral wedge) value (mm) using the transferred landmarks”, [0042-0043], etc.,), and
wherein the vertebral data for each respective vertebra in the set of vertebrae includes the rotation information relating to the rotation of the respective vertebra ([0013], [0019], [0037] etc.,).
As to claim 5, Forsberg discloses the method of claim 1.
Forsberg further discloses the method wherein, for each respective vertebra in the set of vertebrae, identification information relating to an anatomical identification of the respective vertebra is calculated based on the representation of the set of vertebrae, and wherein the vertebral data for each respective vertebra in the set of vertebrae includes the identification information relating to the anatomical identification of the respective vertebra (Fig. 6-7, see identification information T1-L5, see also identification information associated with end and apical vertebrae, [0097] “In particular embodiments, the target organ is the entire spine from T1-L5 although it is contemplated that only certain spine regions may be targeted for evaluation, e.g., T1-T12 or L1-L5, or T11-L4, for example”, [0119] “The model M can be configured to separate into different components, e.g., discrete vertebrae, and/into different planes for each vertebrae and to show the different components in different planes to allow a user to see or change landmark positions”, etc.,).
As to claim 6, Forsberg discloses the method of claim 1.
Forsberg further discloses the method wherein a representation of a central line of the set of vertebrae is calculated based on the representation of the set of vertebrae (Fig. 5B, [0124] “To improve the initial starting point for the registration, a pre-processing routine can be used to estimate an initial pose (position and rotation) of each vertebra as described above. Referring to FIGS.5A-5G, the pre-processing can include: extraction of the spinal canal centerline (FIGS. 5A, 5B), disc detection (FIG. 5C), vertebra center point estimation (FIG. 5D, 5E) and vertebra rotation estimation (FIG.5F, 5G). For additional discussion of suitable pre-processing methods, see, e.g., D. Forsberg, C. Lundström, M. Andersson, L. Vavruch, H. Tropp, and H. Knutsson. Fully automatic measurements of axial vertebral rotation for assessment of spinal deformity in idiopathic scoliosis. Physics in Medicine and Biology, 2013”), and wherein the vertebral data is calculated based on the representation of the central line (Fig. 5G and associated processing steps on the basis of spinal canal centerline at Fig. 5B, [0124] and measurement calculation of (g) on the basis of (c)-(f) [0008]).
As to claim 7, Forsberg discloses the method of claim 6.
Forsberg further discloses the method wherein, for each measurement point in a set of measurement points (Fig. 6 ‘measurement points’ for each of T1-L5, in view of [x,y,z] position, [0149], etc.,), distortion information relating to a deviation of the central line from a reference direction is calculated based on the representation of the central line (Fig. 6 deviation/difference between the fitted and estimated values for the case of rotation θy (frontal rotation) and rotation θx (sagittal rotation) in particular – [0150-0152]), and
wherein the vertebral data for each measurement point in the set of measurement points includes the distortion information relating to the deviation of the central line from the reference direction (see claim 1 above calculated measures include those respective rotation measures and this information is part of that ‘provided’ in view of Fig. 6 and 7, see [0013] “The method can include electronically generating a plurality of graphs of T1-L5 curvature using the calculated measurements, including graphs of displacements (mm) x vs. z and y vs. z, a graph of the calculated local deformity (mm) vs. z and at least one graph of a respective rotational measurement of one or more of rotation θx, θy, θz, in degrees vs. z”, [0019] “wherein … θz corresponds to axial vertebral rotation, θy corresponds to frontal rotation and θx corresponds to sagittal rotation”, [0037] generated graphs illustrating calculated measurements, etc.,).
As to claim 13, this claim is the system claim corresponding to the method of claim 1 and is rejected accordingly. See Forsberg Fig. 9 and 10, processor 300, I/O circuits 346 and I/O device drivers 358, memory 336, etc.,.
As to claims 14-15, these claims are duplicate non-transitory CRM claims corresponding to the method of claim 1 and system of claim 13, and are rejected accordingly. See memory 336 housing application programs 354, and that non-transitory CRM disclosure of [0060].
As to claim 16, this claim comprises limitations sufficiently corresponding to those of claim 4, however depends on claim 2 whereas claim 4 depends directly on claim 1. Claim 16 is rejected accordingly (see rejection of claims 2 and 4 above).
As to claim 17, this claim comprises limitations sufficiently corresponding to those of claim 4, however depends on claim 3. Claim 17 is rejected accordingly (see rejection of claims 3 and 4 above).
As to claim 18, this claim comprises limitations sufficiently corresponding to those of claim 5, however depends on claim 4 whereas claim 5 depends directly on claim 1. Claim 18 is rejected accordingly (see corresponding rejections above).
As to claim 19, this claim comprises limitations sufficiently corresponding to those of claim 6, however depends on claim 4 whereas claim 6 depends directly on claim 1. Claim 19 is rejected accordingly (see corresponding rejections above).
As to claim 20, this claim comprises limitations sufficiently corresponding to those of claim 7, despite differences in associated claim dependency, and is rejected accordingly.
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.
1. Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Forsberg (US 2014/0323845 A1) in view of Schmidt et al. (US 2019/0103190 A1).
As to claim 8, Forsberg discloses the method of claim 6.
Forsberg fails to explicitly disclose the method wherein a projection of the central line into first projection plane is calculated based on the representation of the central line, and wherein the vertebral data is calculated based on the projection of the central line into the first projection plane. Forsberg discloses those rotation measures as being broken down into sagittal θx and frontal θy components, [0158-0160], etc., however features projection disclosure limited to axial vertebral rotation (AVR) measures [0144] “The AVR is estimated as the angle between the normal vector of the frontal plane of the vertebra and the normal vector of the frontal plane of the image volume, projected onto the axial plane of the vertebra” and a projection of curvature measures into a subspace spanned by PCA eigenvectors ([0158] with reference to Fig. 8). Forsberg does however at the minimum suggest the manner in which projection from one space to another may serve to better illustrate/convey curve/rotation characteristics (Fig. 8).
Schmidt however evidences the obvious nature of projecting/rotating a central line characterizing vertebrae (Fig. 3 304, 3D model line) to each of a first/sagittal plane and second/coronal/frontal plane (Figs 8A-8B, [0104]) and providing vertebral data on the basis of such projections/rotations/planes (Figs 8A-8B, projecting/rotating preoperative spine model curves 802 to each respective plane for display relative to those straight/vertical reference lines for each, [0104] “FIG. 8A is an exemplary graph illustrating a three-dimensional model rotated to the sagittal view. The three-dimensional model includes a preoperative curve 802 and a postoperative curve 804. The sagittal view of FIG. 8A shows that the surgeon corrected the spine to put it in proper alignment. However, as shown in FIG. 8B, in which the three-dimensional model is rotated to the coronal view, the spine is out of balance. The postoperative curve 804 shows that the patient is leaning the patient's right. In embodiments, this information is useful in performing future spinal surgeries on the patient whose spine is illustrated in FIGS. 8A and 8B, or on other patients who have not yet undergone surgery”; Schmidt evidences the obvious nature of the manner in which the differing views/planes in conjunction may convey (differently and/or in a complementary manner) the nature of a characteristic curve as well as respective vertebra rotations).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date, to modify the system and method of Forsberg so as to further comprise projecting a central line characterizing vertebrae to each of a first/sagittal plane and second/coronal/frontal plane, and providing vertebral data illustrating/representing such a line in each plane as taught/suggested by Schmidt, the motivation as similarly taught/suggested in Schmidt and readily recognized by POSITA that each in conjunction may serve to convey a more comprehensive characterization of the central line/associated vertebrae.
As to claim 11, this claim comprises limitations similar to those of claim 8, but additionally for a ‘second’ projection plane (as opposed to a first) – which best corresponds to a frontal plane as distinguished from the sagittal/first, and is rejected accordingly in view of that modification/ motivation as identified in the rejection of claim 8 above (addressing both planes as taught/suggested by Schmidt).
2. Claims 9, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Forsberg (US 2014/0323845 A1), in view of Schmidt et al. (US 2019/0103190 A1) and Illes et al. (US 2013/0202179 A1).
As to claim 9, Forsberg in view of Schmidt teaches/suggests the method of claim 8.
Forsberg fails to explicitly disclose any normal as required according to the method of claim 9. Forsberg at best discloses a normal vector of a frontal plane of the image volume, projected onto the axial/horizontal plane as part of that AVR of [0144].
Illes evidences the obvious nature of a system/method comprising calculating a first normal to the curve into the first/sagittal plane, perpendicular to a central line/associated vertebral points, and parallel to the first projection plane, and further calculating distortion information based on said normal (Fig. 2B, 3B, vector 1 projected as 24 in the sagittal plane, 20 in the frontal plane for each vertebrae of T1-LV as illustrated in Table 1, [0038] “The calibrated coordinate system in the frontal, sagittal and horizontal plane is illustrated in FIGS. 2A, 2B and 2C, respectively”, [0041-0042], [0051] “Visualization of the scoliotic spine showing a major right convex thoracolumbar curve (Lenke type IA [1]) is illustrated in FIGS. 5A-5C. Vertebra vectors T1-LV of the thoracic and lumbar region are shown in FIG. 5A in the frontal plane, in FIG. 5B in the sagittal plane, and FIG.5C in the horizontal plane. For easier differentiation of vertebrae”).
It would have been obvious to a person of ordinary skill in the art, before the effective filing date, to further modify the system and method of Forsberg in view of Schmidt to further comprise calculating projection(s) of vectors/normals to the curve/associated vertebrae landmarks into the sagittal and frontal planes as taught/suggested by those similarly calculated vertebra vector parameters of Illes, the motivation as similarly taught/suggested therein that such a means for characterizing vertebra rotation may more comprehensively/completely characterize associated spinal deformities in a manner further characterized by a reasonable expectation of success.
As to claim 10, Forsberg in view of Schmidt and Illes teaches/suggests the method of claim 9.
Illes further evidences the obvious nature of a system/method wherein, for each measurement point in the set of measurement points, distortion information relating to the deviation of the central line from the reference direction includes a first item of angle information (Illes Figs. 5B, 6B comprising those corresponding vectors as items of angle information as permissibly interpreted in view of a plain meaning interpretation – MPEP 2173.01 and 2111), and wherein the first item of angle information relates to an angle between the projection of the first normal to the curve into the first projection plane and an axis which lies in the first projection plane and is perpendicular to the reference direction (Illes as applied above for the case of claim 9, for vector 1 as projected 24 into the sagittal plane, in view of Figs. 5B, 6B etc., (and 5A and 6A for corresponding vectors 20 in the frontal plane – claim 12)).
As to claim 12, this claim comprises limitations similar to those of claim 9, but for the case of that second/frontal plane, and is rejected accordingly in view of Illes as applied in the rejection of claims 9/10 (with reference to Figs. 5A and 6A of Illes and associated disclosure, for vector/angle information associated with the frontal plane and that disclosure as identified above for the case of claim 9 but for 20 in the frontal plane as distinguished from 24 and Figs. 5B and 6B).
Additional References
Prior art made of record and not relied upon that is considered pertinent to applicant's disclosure:
Additionally cited references (see attached PTO-892) otherwise not relied upon above have been made of record in view of the manner in which they evidence the general state of the art.
Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IAN L LEMIEUX whose telephone number is (571)270-5796. The examiner can normally be reached Mon - Fri 9:00 - 6:00 EST.
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/IAN L LEMIEUX/Primary Examiner, Art Unit 2669