DETAILED ACTION
Status
This Final Office Action is in response to the communication filed on 8 July 2025. Claims 12-15 and 17 have been canceled currently or previously, claims 1-4, 6, 11, 16, and 18-21 have been amended, and new claim 22 has been added. Therefore, claims 1-11, 16, and 18-22 are pending and presented for examination.
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
A summary of the Examiner’s Response to Applicant’s amendment:
Applicant’s amendment overcomes the rejection(s) under 35 USC § 112; therefore, the Examiner withdraws the rejection(s).
Applicant’s amendment does not overcome the rejection(s) under 35 USC § 101; therefore, the Examiner maintains the rejection(s) while updating phrasing in keeping with current examination guidelines.
The Examiner indicates allowability over the prior art.
Applicant’s arguments are found to be not persuasive; please see the Response to Arguments below.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 May 2025 were filed after the mailing date of the application on 11 June 2021. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Examiner’s Notes
The Examiner notes the reference to “Ex Parte Olson, No. 11696856 (P.T.A.B. Jul. 21, 207), at pg. 10 (citing MPEP § 2106.05(e))” at 13 March 2025 Remarks, p. 18. This is, as explained below, apparently an error or a fabrication. Therefore, if Applicant cites to a case for argument or other purposes, it is STRONGLY requested that Applicant provide a copy of that reference so that it may be considered. If a copy is not provided, the reference may be considered non-persuasive since it cannot be assured to be found, or the same document.
The Examiner notes that independent claim 1 recites that “no location exists … at which a first voxel intensity exceeds a threshold intensity value … in the patient-specific CT image data along the vector extending from the first surface point because of at least one of: incomplete information in the patient-specific CT image data, corruption of data, movement of the patient, or any other type of anomaly”, and independent claims 18 and 21 recite the same or parallel phrasing. Since there is no actual determination of a cause for “no location exist[ing]” at either the claims or the description, this is interpreted as no location existing because of any reason whatsoever. The phrase “or any other type of anomaly” appears to encompass any possible reason why there is low voxel intensity – i.e., that it is itself an anomaly that no location exists.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 1-11, 16, and 18-22 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent claims 1, 18, and 21 each now recite “to store patient-specific computed tomography (CT) image data generated from patient; and … receive the patient-specific CT image data from the memory; receive an initial shape for a soft tissue structure of the patient” (at claim 1, parallel phrasing at claims 18 and 21). The Examiner has searched for the initial shape being “soft tissue structure of the patient” (emphasis added), but does not find it. Applicant ¶¶ 0061-0062, 0106, 0113, 0116 et al. indicate that the “The initial shape may be a statistical mean shape (SMS) derived from a population of subjects or any geometric shape” (at 0061, and similar at 0106, 0113), and “to fit and scale the initial shape to the patient-specific image data” (at 0062), “to change the initial shape to the patient-specific shape representative of the soft-tissue structure of the patient” (at 0106), etc. However, the current phrasing of the claims is that the initial shape is already existing such that it is merely received, and it is “a soft tissue structure of the patient” – apparently meaning that the initial shape is the soft tissue structure of the specific patient from which CT image data is generated and for which that data has been stored. This is to say, the specification indicates the initial shape as a generic or general shape that is then altered or changed so as to fit to the patient, but the claims indicate that the initial shape is already specific to the patient.
Claims 2-11, 16, 19-20, and 22 depend from claims 1 or 18, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 2-11, 16, 19-20, and 22 are also lacking written support.
Claims 1-11, 16, and 18-22 are 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.
Independent claims 1, 18, and 21 each now recite “to store patient-specific computed tomography (CT) image data generated from patient; and … receive the patient-specific CT image data from the memory; receive an initial shape for a soft tissue structure of the patient” (at claim 1, parallel phrasing at claims 18 and 21). As indicated above, there does not appear to be support for the initial shape being “soft tissue structure of the patient”. However, this recitation also apparently creates indefiniteness regarding what is actually being done.
As explained above, the current phrasing of the claims is that the initial shape is already existing such that it is merely received, and it is “a soft tissue structure of the patient” – apparently meaning that the initial shape is the soft tissue structure of the specific patient from which CT image data is generated and for which that data has been stored. But claims 1, 18, and 21 each also later recites to “iteratively move the plurality of surface points towards respective locations of the one or more contours to change the initial shape to a patient-specific shape that is representative of the soft tissue structure” (at claim 1, with parallel phrasing at claims 18 and 21). However, the claims indicate that the received “initial shape [already IS] a soft tissue structure of the patient” – i.e., that the initial shape already is a patient-specific shape that is representative of the soft tissue structure. So, even if all the claim processes were performed (e.g., contour identification, vector extending, location determination, voxel determination, etc.), the claimed process apparently would arrive at the same patient-specific soft tissue structure initial shape image that was received at the start of the claims. Therefore, the Examiner is uncertain what is actually required at the claims, and/or what is possibly meant by “receive an initial shape for a soft tissue structure of the patient”.
For purposes of examination, the phrase “receive an initial shape for a soft tissue structure of the patient” is being interpreted as being a general or generic shape of typical or usual structure (such as a statistical mean shape, or SMS) that is then changed or modified so as to represent the specific patient.
Claims 2-11, 16, 19-20, and 22 depend from claims 1 or 18, but do not resolve the above issues and inherit the deficiencies of the parent claim(s); therefore claims 2-11, 16, 19-20, and 22 are also indefinite.
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 1-11, 16, and 18-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Please see the following Subject Matter Eligibility (“SME”) analysis:
For analysis under SME Step 1, the claims herein are directed to a system (claims 1-11, 16, and 22), method (claims 18-20), and a non-transitory computer-readable storage medium, which would be classified under one of the listed statutory classifications (SME Step 1=Yes).
For analysis under revised SME Step 2A, Prong 1, independent claim 1 recites a system comprising: a memory configured to store patient-specific computed tomography (CT) image data generated from patient; and processing circuitry configured to: receive the patient-specific CT image data from the memory; receive an initial shape for a soft tissue structure of the patient; determine a plurality of surface points on the initial shape; register the initial shape to the patient-specific CT image data; identify one or more contours in the patient-specific CT image data that is representative of a boundary of the soft tissue structure; wherein the processing circuitry is configured to, as part of identifying the one or more contours, for at least a first surface point of the plurality of surface points on the initial shape: extend a vector from the first surface point; and determine that no location exists in the patient-specific CT image data along the vector extending from the first surface point at which a first voxel intensity exceeds a threshold intensity value, wherein no location exists in the patient-specific CT image data along the vector extending from the first surface point because of at least one of: incomplete information in the patient-specific CT image data, corruption of data, movement of the patient; or any other type of anomaly; based on a determination that no location exists in the patient-specific CT image data along the vector extending from the first surface point at which the first voxel intensity exceeds the threshold intensity value: select a new surface point to replace the first surface point; extend a new vector normal from the new surface point; and define a first contour of the one or more contours based on a location in the patient-specific CT image data along the new vector at which a second voxel intensity of the location exceeds the threshold intensity value; iteratively move the plurality of surface points towards respective locations of the one or more contours to change the initial shape to a patient-specific shape that is representative of the soft tissue structure, wherein, for each iteration of iteratively moving the plurality of surface points, the processing circuitry is configured to at least, for each respective surface point of the plurality of surface points: determine a respective vector normal to the initial shape at the respective surface point; determine, based on the respective vector, a plurality of potential locations associated with the one or more contours; determine, for each potential location of the plurality of potential locations, a location vector normal to the one or more contours at the potential location; calculate angles from the respective vector to each location vector of the plurality of potential locations; select a single potential location from the plurality of potential locations based on the angles from the respective vector to each location vector from the plurality of potential locations; and move the respective surface point at least partially towards the selected single potential location; and output the patient-specific shape for display.
Independent claims 18 and 21 are analyzed in the same manner as claim 1 above since directed to a method comprising performing the same (or similar) activities by using a memory (for the storing step) and processing circuitry (for the remaining steps) (at claim 18), and a computer-readable storage medium comprising instructions that, when executed, cause processing circuitry to also perform the same (or similar) activities as at claim above (for claim 21).
The dependent claims (claims 2-13, 15-17 and 19-20) appear to be encompassed by the abstract idea of the independent claims since they merely indicate determining a soft tissue characteristic such as a fatty infiltration ratio (i.e., a calculated ratio) and displaying that (claims 2-3 and 19) as determined by applying a mask and a voxel threshold to determine fat volume and a fatty infiltration value (claims 3 and 19), the soft tissue characteristic being an atrophy ratio (claims 4 and 20) determined by bone to muscle dimensions, a statistical mean shape (SMS), deforming the SMS via algorithm, and dividing SMS volume by a volume of soft tissue structure (claims 5 and 20), the soft tissue characteristic being at least one of fatty infiltration value or atrophy ratio and the recommendation of surgery type being based on that characteristic (claim 6), including calculating a sprint constant for the soft tissue characteristic (claim 7) and basing the recommendation on both the fatty infiltration and atrophy ratio (claim 8), determining a humerus range of motion based on fatty infiltration, atrophy ratio, or the spring constant (claim 9), the soft tissue structure comprising one or more rotator cuff muscles (claim 10), the soft tissue characteristic comprising the humerus range of motion (claim 11),as part of a mixed reality user interface (claim 16), and/or overlaying the patient-specific shape on a pre-morbid estimate of soft tissue structure (claim 22)
The underlined portions of the claims are an indication of elements additional to the abstract idea (to be considered below).
The claim elements may be summarized as the idea of using and manipulating a diagnostic scan to recommend a type of surgery; however, the Examiner notes that although this summary of the claims is provided, the analysis regarding subject matter eligibility considers the entirety of the claim elements, both individually and as a whole (or ordered combination). The claims (as amended) indicate multiple abstract ideas or groupings of types of abstract ideas, such as mental processes (e.g., concepts performed in the human mind such as observation, evaluation, judgment, and/or opinion) is also further implicated since the claims are essentially to programming a computer to perform the observations, evaluations, and judgments that are, or would be, generally regarded as within the field of medical professionals such as radiology and radiologists. As amended (e.g., removing the determining of soft tissue characteristics as well as the generating and outputting of a shoulder surgery recommendation), the claims now appear primarily focused on the mental processes of understanding a CT image – i.e., the computer process of emulating the mental observations, evaluations, and judgments by using mathematical adjustments to conform an initial shape for a patient to the specific patient image so as to identify structures and tissues.
This also implicates, or necessarily includes mathematical concepts (e.g., relationships, formulas, equations, and/or calculations) in the claims, especially in determining or calculating normal vectors and angles to locate contours, whether locations exist along a vector, calculating voxel or pixel intensity and comparing it to a threshold, and in further details at several or many of the dependent claims that indicate calculating ratios and values as related to the image data analysis. Further still, the claims also implicate the certain methods of organizing human activity (e.g. … managing personal behavior or relationships between people such as social activities, teaching, and following rules or instructions) grouping of subject matter, where the reading of CT scans, including identifying tissue and intensity of particular areas is what radiologists and orthopedic surgeons have long used in diagnostic imaging such as CT scans (and/or MRIs, etc.) to convey information from the radiologist to the surgeon and/or patient.
Kaus et al. (U.S. Patent Application Publication No. 2007/0211939, hereinafter Kaus) indicates that computed tomography is used for imaging and the manual interpretation or use of such images is performed “by stretching, shifting, or otherwise manipulating small portions of the surface until the entire three-dimensional surface conforms with the organ or other item being contoured. This process is repeated for each image slice of each cancerous region and for each organ at risk” (see Kaus at least at, e.g., 0002-0003¶¶ ; citation hereafter by number only). Although Kaus indicates that the manual procedure “is labor intensive” (Id.), and the overall goal of Kaus is preparation for radiation therapy (instead of shoulder surgery) (Id.), the processes (i.e., both manual and automated) indicated appear to be the same for shoulder surgery preparation as for the therapy Kaus emphasizes; therefore, Kaus indicates that “automation of part or all of the contouring process is desirable” (Kaus at 0004).
Therefore, the claims are found to be directed to an abstract idea.
For analysis under revised SME Step 2A, Prong 2, the above judicial exception is not integrated into a practical application because the additional elements do not impose a meaningful limit on the judicial exception when evaluated individually and as a combination. The additional elements are using a system for automatically generating a shoulder surgery type recommendation, the system comprising: a memory (to store to and receive from) and processing circuitry (to perform the activities, such as for determining or calculating normal vectors and angles to locate contours), and that the images are CT images. These additional elements do not reflect an improvement in the functioning of a computer or an improvement to other technology or technical field, implement the judicial exception with, or by using in conjunction with, a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing (there is no transformation/reduction of a physical article), and/or apply or use the judicial exception in some other meaningful way beyond generically linking use of the judicial exception to a particular technological environment.
The Examiner has considered the factor of whether the claims effect a particular treatment or prophylaxis for a disease or medical condition, and finds that they do not. MPEP § 2106.04(d)(2) indicates, in part:
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration. For example, a step of "prescribing a topical steroid to a patient with eczema" is not a positive limitation because it does not require that the steroid actually be used by or on the patient, and a recitation that a claimed product is a "pharmaceutical composition" or that a "feed dispenser is operable to dispense a mineral supplement" are not affirmative limitations because they are merely indicating how the claimed invention might be used.
Since there is no diagnosis of a medical condition (e.g., even whether there is a condition for which surgery may be appropriate), and particularly since there is no performance of a procedure or treatment, nor any administering of a prophylaxis or treatment, the claims cannot be considered (per the MPEP, and the precedent recited therein) a particular treatment or prophylaxis.
The claims appear to merely apply the judicial exception, include instructions to implement an abstract idea on a computer, or merely use a computer as a tool to perform the abstract idea. The additional elements appear to merely add insignificant extra-solution activity to the judicial exception and/or generally link the use of the judicial exception to a particular technological environment or field of use.
For analysis under SME Step 2B, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements are merely “[a]dding the words ‘apply it’ (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, e.g., a limitation indicating that a particular function such as creating and maintaining electronic records is performed by a computer, as discussed in Alice Corp.” that MPEP § 2106.05(I)(A) indicates to be insignificant activity.
There is no indication the Examiner can find in the record regarding any specialized computer hardware or other “inventive” components, but rather, the claims merely indicate computer components which appear to be generic components and therefore do not satisfy an inventive concept that would constitute “significantly more” with respect to eligibility. Applicant ¶¶ 0081 and 0500 both describe the computing devices used as being or including a general purpose computer, 0081 specifically further indicating that the “Processing device(s) 210 can include a variety of different processing or computing devices, such as servers, desktop computers, laptop computers, tablets, mobile phones and other electronic computing devices, or processors within such devices”.
The individual elements therefore do not appear to offer any significance beyond the application of the abstract idea itself, and there does not appear to be any additional benefit or significance indicated by the ordered combination, i.e., there does not appear to be any synergy or special import to the claim as a whole other than the application of the idea itself.
The dependent claims, as indicated above, appear encompassed by the abstract idea since they merely limit the idea itself; therefore, the dependent claims do not add significantly more than the idea.
Therefore, SME Step 2B=No, any additional elements, whether taken individually or as an ordered whole in combination, do not amount to significantly more than the abstract idea, including analysis of the dependent claims.
Please see the Subject Matter Eligibility (SME) guidance and instruction materials at https://www.uspto.gov/patent/laws-and-regulations/examination-policy/subject-matter-eligibility, which includes the latest guidance, memoranda, and update(s) for further information.
Allowable Subject Matter
Claims 1-11, 16, and 18-22 are indicated as allowable over the prior art of record.
The following is a statement of reasons for the indication of allowable subject matter:
Claims 1, 18, and 21 recite “wherein identifying the one or more contours comprises, for at least a first surface point of the plurality of surface points on the initial shape: extending a vector from the first surface point; and determining that no location exists in the patient-specific CT image data along the vector extending from the first surface point at which a first voxel intensity exceeds a threshold intensity value, wherein no location exists in the patient-specific CT image data along the vector extending from the first surface point because of corruption of data or movement of the patient; based on a determination that no location exists in the patient- specific CT image data along the vector extending from the first surface point at which the first voxel intensity exceeds the threshold intensity value: selecting a new surface point to replace the first surface point; extending a new vector normal from the new surface point; and defining a first contour of the one or more contours based on a location in the patient-specific CT image data along the new vector at which a second voxel intensity of the location exceeds the threshold intensity value”. Although voxel intensity is discussed (see at least Kaus at 0035-0040), and Burke et al. (U.S. Patent Application Publication No. 2015/0080704, hereinafter Burke) describes pixel intensity as related to data corruption (Burke at 0042), there does not appear to be further or adequate discussion regarding what calculations and processing may be specifically performed when inadequate voxel intensity is present. It would therefore appear unreasonable to further combine more art with the previous combination so as to arrive at the currently claimed invention.
Claims 4, 5, and 20 recite an atrophy ratio according to an indicated mathematical calculation basis. Where the art of record, as indicated below indicates determining the atrophy, it is not apparently explicit that the particular mathematic basis for these calculations is disclosed.
Claims 7-8 claim “determin[ing] a spring constant for the one or more soft tissue structures” based on at least one or both of the fatty infiltration value and/or the atrophy ratio. The Examiner notes that the art of record, as below, does not appear to indicate calculating a spring constant. However, the Examiner also notes that there is no particular description of this calculation, but rather it is only described that the spring constant can be represented as “K1, K2, and K3” as at Applicant ¶ 0178, and that “processing circuitry 542 may employ an equation such as K=f(R(FI), R (A)), where K is the spring constant, FI is the fat infiltration, and A is the atrophy of the respective muscle, to determine the spring constant of each muscle”. This is literally just the mere indication of the factors including fatty infiltration and/or atrophy, but does not provide any reasonable basis for how to enable actually performing the calculation or arriving at an actual spring constant. The support therefore, is only for the abstract idea of performing the calculation and nothing more.
Claim 9 recites “determin[ing] a range of motion of a humerus of the patient (0240, “Visualization of the simulated ranges of motion using MR system 212 can help the surgeon confirm the surgical plan or may lead the surgeon to update or modify the preoperative surgical plan”) but not explicitly that this is based on at least one of the fatty infiltration value, the atrophy ration, or the spring constant, and the Examiner does not find art of record to indicate the basis of the range of motion determination. Range of motion is generally indicated in prior art as a measured characteristic of an individual rather than as a basis of tissue or joint imaging analysis.
Claims 2-11, 16, 19-20, and 22 depend from at least claims 1 and 18 and therefore are also indicated as allowable over the prior art of record per the above.
Response to Arguments
Applicant's arguments filed 8 July 2025 have been fully considered but they are not persuasive.
Applicant first argues the 101 rejection (Remarks at 12-23), repeating claim 1 (Id. at 13-14), then discussing Step 2A, Prong 1 in relation to each of the abstract idea groupings (Id. at 15-18), first arguing the mental processes grouping (Id. at 15-17) indicating that “Applicant asserts that the amended claims, such as amended independent claim 1, do not recite a judicial exception” (Id. at 15). Applicant first argues that “FIGS. 18A-18B and associated discussion in Applicant's specification describe technical processes for registering such shapes, such as using cost functions and finite parametric equations computed by processing circuitry to register the shape10. In light of Applicant’s specification, a human mind could not practically "register [an] initial shape to [] patient-specific CT image data," as such a function is a complex image processing function of a computer.” (Id. at 15-16 –footnote 10 indicating Applicant ¶¶ 0164-0168). However, Applicant ¶¶ 0160-0168 appear to all phrase the activities as “conceptual illustrations of example patient-specific data” that “may” and/or “can” be used. As such, examples from the specification do not show the entire light of the specification, i.e., they are not definitions that limit “register[ing]” and such limitations should not be read into the claims (see, e.g., MPEP § 2111.01(II)). Further, as indicated at the rejection, the claims are understood to indicate several groupings, where even if the specific functions and equations were read into the registering step, the argument is merely an indication that this is then part of the mathematical concepts aspect (i.e., grouping portion) of the overall abstract idea. The Examiner notes that MPEP § 2106.04(II)(A)(2) indicates that
Because a judicial exception is not eligible subject matter, Bilski, 561 U.S. at 601, 95 USPQ2d at 1005-06 (quoting Chakrabarty, 447 U.S. at 309, 206 USPQ at 197 (1980)), if there are no additional claim elements besides the judicial exception, or if the additional claim elements merely recite another judicial exception, that is insufficient to integrate the judicial exception into a practical application. See, e.g., RecogniCorp, LLC v. Nintendo Co., 855 F.3d 1322, 1327, 122 USPQ2d 1377 (Fed. Cir. 2017) ("Adding one abstract idea (math) to another abstract idea (encoding and decoding) does not render the claim non-abstract"); Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016) (eligibility "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself.").
Applicant then asserts analogy to “Research Corp. Techs. v. Microsoft Corp.” alleging that “the Federal Circuit found … ‘nothing abstract’” in the claims (Remarks at 16). The Examiner notes that this is Example 3 for Digital Image Processing at the subject matter eligibility examples (see https://www.uspto.gov/sites/default/files/documents/101_examples_1to36.pdf at pp. 7-10), and where the Examiner must apply the current guidance for eligibility analysis, the analysis for Example 3 indicates “The courts have found that mathematical relationships fall within the judicial exceptions, often labelled as ‘abstract ideas.’ Since the mathematical operation of generating a blue noise mask is recited in the claim, the claim is ‘directed to’ a judicial exception (Step 2A: YES)” (Id. at 8), but the claims further generate a blue noise mask to convert the image to a halftone image and “the claimed process with the improved blue noise mask allows the computer to use to less memory than required for prior masks, results in faster computation time without sacrificing the quality of the resulting image as occurred in prior processes, and produces an improved digital image” (Id. at 9). The Examiner notes that it is the improved imaging, processor speed, and memory efficiency that indicate Example 3 as eligible under the current guidance. However, although Applicant’s claims use mathematical concepts to manipulate images, the instant claims do not reflect the same improvements – the instant claims merely output (e.g., overlay, per claim 22) the image and do not appear to improve the computer or memory as indicated by the analysis at Example 3.
Applicant then argues that “the steps of amended claim 1 are not recited at such a high level of generality that they could practically be performed in the human mind…. [such as] "determine a plurality of surface points on the initial shape,""register the initial shape to the patient-specific CT image data,""select a new surface point to replace the first surface point," and "extend a new vector normal from the new surface point," (Remarks at 16). However, this appears to be recognizing soft tissue (as opposed to, or in contrast to, solid matter such as bone), and understanding the structures indicated in the image. The claim is merely phrased to indicate how a computer would perform the operations in a step-by-step sequence rather than a human reading the same image and understanding how the image represents to the patient.
Applicant then alleges that “output[ting] the patient-specific shape for display”, as based on iteratively moving points to change the initial shape to a patient-specific shape is somehow not one of certain methods of organizing human activity (Id. at 17). However, according to the claims, this is apparently (or apparently can be) merely providing the received soft tissue structure of the patient. And even if there is a new, changed patient-specific shape to display, the displaying of that shape would be insignificant (for example, as extra-solution activity) within the current examination guidelines.
Applicant then argues that “amended claim 1 is not directed towards mathematical concepts” (Remarks at 17, the argument continuing on 18); however, based on the amendment, the previous and current rejections both indicate that the claims may not be wholly directed to the mathematical concepts included in the activities, but the grouping is included as further implicated based on MPEP § 2106.04(a) indicating that “examiners should identify at least one abstract idea grouping, but preferably identify all groupings to the extent possible, if a claim limitation(s) is determined to fall within multiple groupings and proceed with the analysis in Step 2A Prong Two”. Including multiple groupings of abstract ideas does not make a claim eligible.
Applicant then argues that Kaus does not describe the same process and “fails to make any teaching or suggestion regarding "register the initial shape to the patient-specific CT image data;... based on a determination that no location exists in the patient-specific CT image data along the vector...: select a new surface point to replace...; extend a new vector normal...; and define a first contour... based on a location in the patient-specific CT image data along the new vector...," as recited by amended claim 1” (Remarks at 16, emphasis at original). However, first, the argument is attempting to apply prior art analysis instead of eligibility analysis, but eligibility analysis does not include prior art analysis – they are quite separate analyses. Second, the activities indicated are how a computer would be programmed to perform activities, and not necessarily precisely the same process for manual implementation vs. applying the abstract idea via computer. If the argument were to be believed or given weight as persuasive, it would very literally overrule Alice Corp and other such precedent – Alice et seq. also did not have exactly the same process steps as indicated by the abstract idea since it recited the use of a computer.
Applicant then argues Step 2, Prong 2, alleges analogy to Example 40 (Remarks at 19-20); however, the instant claims do not limit data collection, especially not in the same way, and the claims do not improve network monitoring or provide similar, analogous improvements. Applicant’s argument indicates the claims receive image data, identify a contour, and output a patient-specific shape; however, these are all aspects of the abstract idea. Applicant further argues that the claims also further recite determining no location on a vector exceeds a voxel threshold, selecting a new surface point, extending a vector, and defining a contour, “which … should be sufficient to render amended claim 1 patent-eligible” (Id.). However, those aspects of the claims are also part of the abstract idea in that they are using mathematics to “envision” the anatomy of a patient, like, or the same as, manually and/or mentally reading the received CT image.
Applicant then argues Step 2B, alleging that “The Office has not shown that processing circuitry configured to ‘determine that no location exists in the patient-specific CT image data’ and then ‘define a first contour’ along a new vector as recited by amended claim 1 is in any way routine or conventional in the field” (Id. at 21). However, these aspects are found to be insignificant for another reason – that they are part of the abstract idea and merely applying that abstract idea by use of a computer. The claims apparently are really to how a computer can be used to read a CT image, rather than having a person read the image and understand the contours of various tissues of the patient.
Applicant then finally argues the 112 rejections (Id. at 22-23). However, the previous 112 rejections were overcome and therefore withdrawn. Therefore, Applicant’s arguments are considered moot and not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bell, Daniel J, Voxel, Radiopaedia [online], dated 19 November 2020, downloaded 11 September 2023 from https://radiopaedia.org/articles/voxel?lang=us, indicating a voxel is essentially “a 3-D equivalent of a pixel”.
Bell, Daniel J, Voxel size, Radiopaedia [online], dated 4 September 2018, downloaded 11 September 2023 from https://radiopaedia.org/articles/voxel-size-1?lang=us, indicating voxel size has a trade-off regarding resolution and may contribute to artifacts.
Computed Tomography (CT) Scanning, TeachMeAnatomy [online], dated as “Last updated: April 25, 2018”, downloaded 11 September 2023 from https://teachmeanatomy.info/the-basics/imaging/computed-tomography-ct-scans/ indicates that “Computed tomography (CT) scanning is an extremely common imaging modality in modern medicine”, “The amount of attenuation is determined by the density of the imaged tissue, and they are individually assigned a Hounsfield Unit or CT Number”, and “because of the advanced mathematical algorithms involved with CT, the three-dimensional planes of the human body can be imaged and displayed on a monitor as stacked images, detailing the entirety of the field of interest” (all at p. 1)
Imaging and radiology, from National Institute of Health, National Library of Medicine, MedlinePlus, undated, downloaded 11 September 2023 from https://medlineplus.gov/ency/article/007451.htm#:, describing radiology, radiologists, and imaging technology, including that “The most common types of diagnostic radiology exams include: [at least] Computed tomography (CT), also known as a computerized axial tomography (CAT) scan” and others (at p. 1).
F. Commandeur et al., "Deep Learning for Quantification of Epicardial and Thoracic Adipose Tissue From Non-Contrast CT," in IEEE Transactions on Medical Imaging, vol. 37, no. 8, pp. 1835-1846, Aug. 2018, doi: 10.1109/TMI.2018.2804799, downloaded from https://ieeexplore.ieee.org/abstract/document/8288602 on 13 September 2023, indicating using non-contrast CT scan to assess fat volume and segmentation.
Beeler et al., A comparative analysis of fatty infiltration and muscle atrophy in patients with chronic rotator cuff tears and suprascapular neuropathy, Journal of Shoulder and Elbow Surgery, Vol. 22, Iss. 11, November 2013, pp. 1537-1546, DOI: https://doi.org/10.1016/j.jse.2013.01.028, downloaded on 13 September 2023 from https://www.sciencedirect.com/science/article/pii/S1058274613000852?via%3Dihub, indicating “The development of fatty infiltration (FI) and muscle atrophy (MA) of the rotator cuff musculature is a critical factor for the clinical outcome after treatment of chronic rotator cuff tendon tears” (at 1537-38), and “To date, FI in the rotator cuff musculature is most commonly assessed quantitatively on computer tomography (CT) or magnetic resonance imaging (MRI), using the staging system originally proposed by Goutallier et al and subsequently modified for MRI by Fuchs et al.” (at 1538, left column, second full paragraph).
Goutallier, et al., Fatty Muscle Degeneration in Cuff Ruptures, Clinical Orthopaedics and Related Research, No. 304, pp 78-83, © 1994 JB Lippincott Company, downloaded 13 September 2023 from https://journals.lww.com/clinorthop/Abstract/1994/07000/Fatty_Muscle_Degeneration_in_Cuff_Ruptures__Pre_.14.aspx indicating the Goutallier classification system Applicant indicates as used: “the information regarding the patient's rotator cuff may be expressed in terms of a class in a shoulder pathology classification system, such as a Warner classification system or a Goutallier classification system” (Applicant ¶ 0253).
Kuzel et al., Fatty infiltration and rotator cuff atrophy, Journal of the American Academy of Orthopaedic Surgeons, Vol. 21, Iss. 10, Publisher: American Academy of Orthopaedic Surgeons, DOI: http://dx.doi.org/10.5435/JAAOS-21-10-613, dated Oct 2013, downloaded 13 September 2023 from https://go.gale.com/ps/i.do?p=AONE&u=googlescholar&id=GALE|A348873635&v=2.1&it=r&sid=googleScholar&asid=abfd0a85, indicating various fatty infiltration and rotator cuff atrophy related measurements and studies.
Krekel, P. R. (2011, February 10). Visualisation of articular motion in orthopaedics. Retrieved from https://hdl.handle.net/1887/16455 on 27 February 2024; Chap. 3 (labeled as pp. 30-46) from Proceedings of Simulation and Visualization 2006; SCS Publishing House Erlangen Berlin, pp. 275-288, as cited by Krekel (U.S. Patent Application Publication No. 2013/0191099) at 0004.
Moineau et al., Three-dimensional measurement method of arthritic glenoid cavity morphology: Feasibility and reproducibility, Orthopaedics & Traumatology: Surgery & Research, Vol. 98, Iss. 6, Supplement, 2012, Pages S139-S145, ISSN 1877-0568, https://doi.org/10.1016/j.otsr.2012.06.007. Downloaded 10 December 2024 from https://www.sciencedirect.com/science/article/pii/S1877056812001338, indicating “The goal of this study was to describe and validate the reproducibility of a CT scan-based, 3D measurement method used to describe various parameters characterizing arthritic glenoid cavity morphology…. Twelve CT scans and 29 CT arthrogram were evaluated. These scans were taken from 41 patients with glenohumeral osteoarthritis who received an anatomical shoulder prosthesis. A 3D reconstruction of the scapula was performed based on the DICOM files. Following the 3D volume acquisition, points on the glenoid articular surface were manually extracted by three observers, … The intraclass correlation coefficient (ICC) was calculated on five 3D parameters that were automatically calculated: glenoïd height, glenoid width, height at maximum width glenoid version and radius of the articular surface best-fit sphere…. This study is the first to report on a reproducible 3D measurement method, based on CT scans, for the arthritic glenoid cavity, which derives the joint radius of curvature among other morphology parameters. These 3D measurements are advantageous because they are free of problems related to patient positioning in the CT scanner and to the choice of slices, which limits the accuracy of measurements made on slices from 2D CT scans. Three-dimensional methodology similar to ours has been validated on healthy glenoids.” (at Summary, p. S139).
Ex parte Timothy S. Olson, Appeal 2016-007677, Application 11/969,856, downloaded from https://developer.uspto.gov/ptab-web/#/search/decisions on 2 April 2025, dated 25 July 2017 – a 5 page decision from the PTAB regarding prior art only.
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/SCOTT D GARTLAND/
Primary Examiner, Art Unit 3685