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 .
Response to Amendment
The Amendment filed 05/04/2026 in response to the Non-Final Office Action mailed 02/02/2026 has been entered.
Claims 1, 3-5, 7-13, 15, 17-18 and 20-23 are currently pending (21-23 new and 2, 6, 14, 16 and 19 cancelled) in U.S. Patent Application No. 18/441,359 and an Office action on the merits follows.
Response to Duplicate Claim Warnings
The Duplicate Claim Warning previously identified at page 2 of the Non-Final Office Action is rendered moot by the cancellation of claim 14.
Response to 35 USC § 101 Rejections
Applicant’s remarks with respect to Subject Matter Eligibility Analysis have been considered and determined non-persuasive. Applicant’s remarks, with reference to MPEP 2106.05(a), assert that the claim as a whole, and without any identification of ‘additional elements’ not subsumed under the identified exception, realize an improvement to “the technologies of automated detection and medical diagnosis of scoliosis” (remarks at page 11) and in so doing, are integrated into a practical application at Prong Two of Step 2A. Applicant’s proposed analysis however makes no effort to distinguish any ‘additional elements’ from those limitations subsumed under the exception – and instead identifies those very same ‘calculating’ steps – all drawn under the exception, as being those which realize a purported improvement. So-called ‘additional elements’ (in addition to those drawn under the exception) are required for (but do not themselves guarantee) a finding of integration at Prong Two of Step 2A (and similarly ‘significantly more’ (than the exception itself) at Step 2B). As was previously identified, the improvement cannot be to the exception itself (a novel calculation per se, is not eligible subject matter), the improvement cannot be merely ‘applying’ the exception (2106.05(f) and/or 2106.05(h)), and an automation of what is otherwise capable of being performed by a physician/trained professional visually/mentally/manually analyzing associated medical imagery (Forsberg [0144]), is also generally not recognized as an improvement as described in 2106.05(a) (see contrasting 2106.05(f)). The Federal Circuit, very recently, put similar considerations succinctly at e.g. page 10, reproduced in part below, Dental Monitoring SAS, v Align Technology, Inc., Appeal No. 2024-2270 (Fed. Cir. July 07, 2026), available at - https://www.cafc.uscourts.gov/opinions-orders/24-2270.OPINION.7-7-2026_2719362.pdf
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The recited claim language, under a plain meaning interpretation afforded in view of MPEP 2173.01 and 2111.01, remains very broad – potentially inviting scope of enablement rejections given plain meaning equivalents for “vertebral data” (see MPEP 2164.08 with reference to Wands Factors of 2164.01(a) – the first being the breadth of the claims), and rests with providing the calculated information (in no specific manner). The finally calculated “vertebral data” is not recited in a manner excluding that which may be obtained by a quantitative (or qualitative) assessment performed by a human/physician (even if computer-assisted/viewing imagery obtained by a technological means). Furthermore, Applicant’s remarks at page 10 and with reference to [0007] assert that the claims enable an analysis that may be performed on image data that was obtained/acquired/recorded for a purpose other than vertebral column examination (even if the associated region is an ‘examination region’), however, how the data is obtained and the nature of that data (the claims only require that it concern ‘an examination region’), is not recited, and a practicing physician may similarly evaluate (e.g. calculate a Cobb angle from) medical images that were not necessarily obtained for that purpose. Additionally, Examiner understands it to be accurate, that a Cobb angle can be, and is generally/typically, determined from only a subset of vertebrae and not necessarily the entire spine – particularly if it is not the absolute upper- or lower-most vertebra that are the superior tilted and inferior tilted vertebra. Reference may be made to Forsberg (US 2014/0323845 A1) Fig. 1 – modified with the superimposed box, designating a considered subset, excluding the uppermost 2 and lower-most 3 vertebrae illustrated (and only 11 of 33 vertebrae are illustrated), [0097], etc.. The Examiner has speculated that the instant application may seek to capture the manner in which a minimalist/barebones representation (claim language doesn’t exclude additional aspects of a representation beyond landmarks and lines connecting said landmarks), may be computationally advantageous (see MPEP 2103 sub-section I. and 2106.04(d)(1)), however a minimal representation is more readily drawn to one that may be visually/mentally and manually, even if computer assisted, determined/calculated, and Forsberg at least suggests ([0096]) that geometric based models using non-anatomical geometric shapes may serve as a known/recognized means for modeling vertebrae. At least [0202] of Schmidt et al. (US 2019/0103190 A1) similarly discloses “the visual representation of the anatomical structure … may be any geometric shape or other visually discernible indicator, the purpose of which is to be arranged to simulate the approximate location thereof without the need for the exact details of the structure as described in the other processes disclosed herein”.
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Response to Arguments/Remarks
Applicant's arguments regarding prior art as applied/applicable have been fully considered but they are not persuasive and/or are rendered moot by the new grounds of rejection presented below and in response to the foregoing claim amendment. More specifically, Applicant’s remarks assert that because Forsberg (US 2014/0323845 A1) discloses one or more representations (e.g. at least 5A and 5B – patient specific representations of 205) calculated/generated, prior to the transfer of (transfer at Fig. 11 220 following registration 215, [0104]) landmarks initially associated with a non-patient-specific model M, that Forsberg somehow fails to fairly teach/suggest claim language that falls entirely silent on how the calculated representation and any landmarks, relative to a landmark transfer, may be associated. Applicant’s remarks appear deficient at page 13, final paragraph, in asserting “Therefore, the claimed "representation of the set of vertebrae" must be read onto the landmarks of Forsberg post transfer. See, AIIS”. This is not true, not only because the claims are silent regarding any landmark transfer, but also because the Examiner understands Forsberg to disclose a representation associated with model M, with initial landmarks loaded/assigned/manipulated prior to transfer (Forsberg at [0119-0122] with reference to Figures 4A and 4B), wherein the user can load preset (202, 203 of Fig. 11) and adjust/manipulate landmark placement (201) for a subset (or all) of vertebra(e) of interest ([0119-0122]) and concerning an examination region. Applicant’s remarks faithfully reproduce those considerations identified by the Examiner in the 04/09/2026 Interview Summary (AIIS), but the recited claim language does not appear to address the consideration “and the representation as claimed required such landmarks post transfer” (remarks at page 12, first paragraph, also in AIIS) – even in view of the requirement that the calculated representation be ‘based on the imaging data’, because the imaging data as broadly recited must at most concern ‘an examination region’ (which even model M does). The claim language doesn’t require the received image data to be (or exclude it from being) patient-specific. Even if the claim as amended requires the “representation of a centerline” (Forsberg 5B previously drawn as an equivalent – 5E, and 5G, Figs 6-8, etc., may also serve see below) to be determined from/based on that “representation” calculated in that first calculating step (claim 1 line 5), Forsberg’s patient specific representations if not already (see Fig. 11 205 following 200), may be permissibly modified to be ‘based on’ the ‘calculated representation’ equivalent. Stated differently, if drawing the recited calculated representation to Forsberg’s model M of Fig. 11 200, then 5B, 5E, etc., may be modified to concern only the vertebra(e) and landmarks identified/loaded/ selected/manipulated/ assigned by the user in steps 200-204, and alternatively, Forsberg may be applied such that a ‘central line’ representation equivalent is one after landmark transfer (e.g. 5E, certainly 5G and Figs. 6-8). As alluded to above, an alternative application/mapping of Forsberg may involve the “vertebra centerpoint estimation” (Forsberg Fig. 5E), and/or Forsberg 5G since it inherits those same central line indicia of 5B an 5E, drawn as an equivalent to a “central line of the set of vertebra” – since it/they establish centers for each of a set of vertebrae and feature points generally organized as (when considering those points in the aggregate – see Fig. 5E, 5G) a ‘central line’ (so too are Figs 6-8 such a central line representation equivalent). Applied in such a way, Forsberg need only consider those landmarks loaded/assigned/manipulated by the user at 200-204, prior to any transfer at 220 – and for an interpretation of that recited central line that reads on 5G or later representations, such second representation equivalent(s) is/are based on both initial and post-transfer landmarks. Applicant has demonstrated an appreciable effort in attempting to discern how Forsberg at large may potentially be distinguished from the claimed invention, however disclosure of Forsberg still appears, to the Examiner and given the Examiner’s assessment of the state of the art, applicable/equivalent for each and all of the limitations as broadly recited. Examiner also recognizes that a clear mapping, identifying how Forsberg may best/most appropriately be applied facilitates compact prosecution, however the recited claim language is of a breadth (in view of interpretation as prescribed by MPEP 2111.01 – a plain language reading, not inconsistent with, but also not reading in from the Specification) that appears to permit more than one interpretation/mapping for e.g. ‘calculated representation’ equivalents, ‘received imaging data’ equivalents (which may comprise both patient-specific and non-specific data), and ‘vertebral data’ equivalents in Forsberg and otherwise. Perhaps multiple interpretations is an issue best resolved with rejections under 112(b) (MPEP 2173.02 – a broad genus might be clear, but a genus interpretable so as to be unclear regarding which species are covered, might not), however 2173 cautions against confusing claim breadth with indefiniteness (2173.04 Breadth is not Indefiniteness). A similar but modified grounds of rejection, necessitated by the amendment now requiring that the central line representation be based on that representation including at least one of (i) or (ii) (even for the case that corresponding landmarks are those prior to patient data registration and transfer), is presented below.
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, 3-5, 7-13, 15, 17-18 and 20-23 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, the representation.. including…”, “calculating a representation of a central line of the set of vertebrae”, 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. 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 (see Forsberg 201) landmarks/ keypoints for various vertebrae (thereby calculating a representation), and e.g. calculate a Cobb angle on the basis of superior and inferior 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 – see remarks above, the only ‘additional element’ in claim 1 is the initial receiving, and possibly the final providing – both failing to serve as significantly more in view of 2106.05(g). Also, with reference to e.g. page 12 of the Dental Monitoring SAS, v Align Technology, Inc., Appeal No. 2024-2270 (Fed. Cir. July 07, 2026), referenced in the remarks above, the relevant inquiry is not whether the claimed invention as a whole is unconventional or non-routine, and instead any unconventional limitations may be (but aren’t necessarily) indicative of an inventive concept. 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 (and data collection/ analysis/output falls squarely under the Abstract Idea exception). Limitations not indicative of an inventive concept/ ‘significantly more’ include those that are not specifically recited (instead recited at a high level of generality and/or generally linking to a field of use 2106.05(h)), those that are established as WURC (2106.05(d), however Examiner’s analysis does not rely on any factual finding with respect to WURC), and/or those that are not ‘additional elements’ by nature of their analysis at Prong One (i.e. reciting the exception/calculation(s)), among others (2106.05(f)). (Step 2B: No).
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 1, 3-5, 7-8, 11, 13, 15, 17-18, 20 and 22-23 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 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 (see response to remarks above – ‘image data of an examination region’ may include both patient-specific and non-specific (as required for the generation and rendering of M and portions thereof) image data, image data associated with M, and also 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 ([0119-0122] Calculated representation(s) (to include those manipulated/modified based on user input) associated with model M, Figures 4A-4B, that are not necessarily (prior to registration and transferring steps) patient specific – see remarks above; for the case of a central line representation equivalent that is calculated ‘based on’ this “a representation of the set of vertebrae”, ideal application of Forsberg involves mapping to model-space representation(s) prior to registration/landmark transfer (still having those landmarks of the initial model prior to transfer) – but for the case that Forsberg may be modified to calculate alternate (and/or additional) central-line representations, patient-specific representations of Forsberg may also apply), the representation of the set of vertebrae including, 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 4A-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.,);
calculating a representation of a central line of the set of vertebrae based on see remarks above, Fig. 5B, alternatively Fig. 5E, 5G (which appears to meet ‘based on the representation’ – see below), Figs. 6-8, [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”, etc.,);
calculating the vertebral data based on the representation of the set of vertebrae (Fig. 11 225-229, [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], 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.,) and the representation of the central line (Fig. 5G and associated processing steps on the basis of spinal canal centerline at Fig. 5B, 5E, etc., since all later processing steps and associated calculations are ‘based on’ prior occurring steps, [0124] and measurement calculation of (g) on the basis of (c)-(f) [0008], etc., - see Fig. 11 for a larger context/possible temporal relationships between 200-229, and 225, 228, and 229 in particular as they concern calculated vertebral data equivalents).; 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 is identified in the remarks/mapping above, since the claim requires the central line representation to be ‘based on’ an earlier calculated representation comprising landmarks, and Forsberg 5B is generated prior to landmark transfer, Forsberg is applied such that the calculated representation comprising landmarks is that initial model (not patient specific) based on ‘imaging data of an examination region’. Also, in the context of Forsberg Figs. 5A-5G, Examiner understands landmark transfer to occur after that ‘initial’ estimation at 5D, but potentially prior to 5E and certainly for 5G, wherein for that instance, 5E/5G is ‘based on’ M in view of those assigned/manipulated landmarks prior to and post transfer, and 5B is based on M in view of landmarks prior to transfer. Examiner notes given the recited language that ‘how’ the second (central line) representation need be ‘based on’ the first, is not at issue, but instead what is at issue is whether or not Forsberg may be permissibly modified to have one or more central line representation(s) (e.g. a projection of the central line to one or more views – Figs. 6-8) calculated ‘based on’ any prior calculated representation (e.g. a sub-volume in view of user manipulated model M – Fig. 11 210 prior to registration), and/or any calculated representation more broadly if central-line representation equivalents (from a post registration and landmark transfer, thereby made patient-specific) may be drawn to the disclosure of e.g. Forsberg Figs. 6-8.
Forsberg suggests at least the latter, because Forsberg discloses central line representations (not constrained to e.g. 5B), calculated post landmark transfer – e.g. at least Figures 6-8. Forsberg further discloses calculating central line representations that are view and patient specific (same figures, given x, y and z indices, [0158-0160], etc.,).
Schmidt further evidences the obvious nature of calculating a central line representation, based on earlier/prior calculated ‘representation(s)’, that are view specific (Figs 8A-8B).
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 calculate one or more ‘central line representation’ equivalents ‘based on’ any of earlier determined/ calculated representations comprising landmarks as taught/suggested by Forsberg and Schmidt (e.g. to one or more views of interest, or composite views of interest), the motivation as similarly taught/suggested in both references and readily recognized by PHOSITA, that such a central line representation calculation may serve to convey a more comprehensive characterization of the central line/associated vertebrae locations given the known/recognized differences between at least sagittal and coronal views.
As to claim 3, Forsberg in view of Schmidt teaches/suggests the method of claim 1.
Forsberg further suggests the method wherein a representation of the set of vertebrae is calculated based on the imaging data by applying a segmentation algorithm to at least a portion of 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.,).
Forsberg further suggests a segmentation/separation of non-patient specific image data in at least [0122], with reference to UI 20c.
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 apply any of known/recognized segmentation algorithms to segment/separate one or more sub-volumes/portions of interest.
As to claim 4, Forsberg in view of Schmidt teaches/suggests 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 in view of Schmidt teaches/suggests 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 7, Forsberg in view of Schmidt teaches/suggests the method of claim 1.
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 8, Forsberg in view of Schmidt teaches/suggests the method of claim 1.
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) – see also that modification and rationale as presented above for the case of claim 1. In other words, Forsberg discloses at least three, plane/view specific central line representations, but features limited disclosure, recognizable by the Examiner, regarding “projection”.
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 (and Forsberg even if those plane/view specific representations are not resultant from projection), 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 accounting for measures from the view/plane information upon which the projection is based.
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).
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 claim 15, this claim is the non-transitory CRM claim corresponding to the method of claim 1 and system of claim 13, and is rejected accordingly. See memory 336 housing application programs 354, and that non-transitory CRM disclosure of [0060].
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 20, this claim comprises limitations sufficiently corresponding to those of claims 7 and 4, and is rejected accordingly.
As to claim 22, Forsberg in view of Schmidt teaches/suggests the method of claim 1.
Forsberg further discloses the method wherein the imaging data comprises two dimensional data of the examination region (Figs. 4A-4B, [0094] “As known to those of skill in the art, traditional medical systems are bound by the 2D slice format used by the imaging modalities and use this base to construct higher-dimensional data”, etc.,).
As to claim 23, Forsberg in view of Schmidt teaches/suggests the method of claim 1.
Forsberg further discloses the method wherein the set of vertebrae does not include all vertebrae belonging to the vertebral column ([0122] “A UI 20c can be provided to allow a user to define whether to change the landmarks in all or selected ones of the vertebrae V (shown as a selectable input of change all/change one)”, Fig. 1, remarks above, etc.,; Forsberg further suggests that select vertebra (well below the full 33 – even if 12 thoracic and 5 lumbar are evaluated – omitting 7 cervical spine and those of the sacrum/coccyx), may be those “undergoing evaluation”, [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”).
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).
3. Claim 21 is 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 Yang et al. (US 2018/0260951 A1).
As to claim 21, Forsberg in view of Schmidt teaches/suggests the method of claim 1.
Forsberg suggests the method further comprising, determining at least one of a shape or a size of each respective vertebra in the set of vertebrae for the representation of the set of vertebrae (Forsberg suggests determining both shape and size information as required for the purposes of at least rendering for user interaction in view of 20c, one or more portions of model M (e.g. [0096]), however under such an application of Forsberg such a shape and size determination is for the/a representation and arguably not determined from it - support found at [0023-0024] of Applicant’s Specification); and
Forsberg discloses based on one or more calculated representations, determining identification information relating to an anatomical identification of each respective vertebra based on the at least one of a shape or the size 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., see also [0194] “In addition, an advantage of the method in Klinder et al. 2009 is that that proposed method provides automatic identification of the vertebrae as well”).
It stands to reason, similar to the way Forsberg discloses initial/estimated shape and size determinations made based at least in part on patient information to include e.g. male/female, age, weight, etc. ([0096]), that shape and size information may be gleaned from patient specific and non-patient specific images alike, particularly if complementary information is known – as any of a calculated metric itself falling under permissible interpretation of ‘vertebral data’, and/or for the purposes of anatomy identification.
Yang further evidences the obvious nature of determining at least one of a shape or a size of each respective vertebra in the set of vertebrae based on a representation broadly, and for the purposes of vertebra identification (Final output vertebra identifiers at 210, include e.g. labels such as C1-S2, [0032], based on shape basis network 106).
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 ascertaining, based on one or more representation(s) of Forsberg in view of Schmidt, characteristics such as shape and/or size for each of represented vertebra, as taught/suggested by Yang, in further view of the manner in which such characteristics are known/recognized to be generally distinguishing features that may facilitate manual and/or automatic anatomy identification as suggested by at least Yang (given Yang’s success in utilizing such features for identification purposes), the motivation as similarly taught/suggested therein and readily recognized by PHOSITA that such features, at least as corroborating identification characteristics, may serve to validate finally/subsequently/concurrently calculated metrics.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
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