DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Responsive to the communication dated 10/08/2025
Claims 1, 4-12, 16-20, 22-27, and 30 are presented for examination
Finality
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 extension fee 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.
Response to Arguments-112
Applicant’s arguments, see page 12, filed 10/08/2025, with respect to the rejection of claims 3, 20, 22-27, and 30 under 112(b) and 112(d) have been fully considered and are persuasive. The rejection of claims 20, 22-27, and 30 under 112(b) and 112(d) has been withdrawn.
It should be noted, however, that the new amendments have created new issues. See the claim objections and 112 rejection sections of this action.
Response to Arguments-101
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive.
Applicant argues that the claims are eligible because they recite “a number of hardware components working together…”
Examiner responds by explaining that the use of generic computer hardware to perform an abstract idea is not sufficient to integrate the claims into a practical solution nor provide significantly more. See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015)”)
Applicant argues that the generation a digital model from raw medical data is impossible to perform in the human mind.
Examiner responds by firstly explaining that a number of the argued features are not claimed, For example that this generation requires “taking raw tomographic (DICOM) slices and reconstructing a 3D digital model using computational algorithms. The specification describes this as involving back- projection, ray-casting, and GPU-accelerated processing … involves 3-D reconstruction from raw tomographic (DICOM) slices requires Fourier back-projection, ray-casting and GPU parallelization - mathematics that cannot be executed in real time by a human.”
Given its broadest reasonable interpretation in view of the disclosure, the limitation of “reconstructing, at the processor, a digital model from the obtained raw medical imaging data, wherein the digital model comprises a two-dimensional image representation or a three-dimensional image representation;” requires no particular computational technique, data type, or that it be performed in real time.
With such a broadest reasonable interpretation, “raw medical imaging data” could be complicated slices from a CT system; or, they could be simple photographs of the patient. Similarly, the generation of this model could be a complex process involving advanced algorithms, or it is just as easily read on by a person observing a photograph of the patient and creating a new representation of it, for example by drawing a rendition of the photograph with a pencil and paper. As no particular method for this generation is claimed, using a computer to perform this process digitally amounts to no more than mere instructions to apply.
Applicant argues the claims are eligible because they recite voxel generation steps, particularly: “generating, at the processor, several three dimensional textures voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the three dimensional textures voxels representing different surfaces of individual anatomical elements and further, that involve voxel creation and statistical segmentation employ optical-flow demons algorithms, Gaussian regularization and machine-learning classifiers”
Examiner responds by firstly explaining that a number of the argued features are not claimed, and, in view of the disclosure, the broadest reasonable interpretations of the relevant limitations are significantly broader.
The limitations of “generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements ;extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure,” do not require “statistical segmentation … optical-flow demons algorithms, Gaussian regularization and machine-learning classifiers.” Not that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In light of this, the generation and processing of said voxels is merely equivalent to a mental process and mere instructions to apply said mental process on a general purpose computer. Particularly, generating a set of voxels for different types of tissues is a mental process equivalent to drawing perspective drawings of those tissues made of cubes, as with a pencil and paper. This kind of voxel drawing is occasionally done by children drawing their favorite characters from games like Minecraft; extracting the elements to create a selection of voxels is equivalent to identifying groups of voxels that represent an organ, for example, a person could observe a set of voxels representing different body parts and differentiate the skeleton from, for example, the stomach; selecting contiguous voxels is equivalent to indicating that a set of neighboring voxels are selected, such as by drawing a circle around them with a pen and paper; expanding or propagating this selection is merely the process of drawing a bigger circle that contains more voxels than the original selection; identifying concave shapes is a mental process equivalent to observing a shape and judging whether or not it is concave; identifying organ shapes is a mental process equivalent to observing a shape and judging whether or not it matches the known shape of an organ, such as the shape of the lungs or of wrist bones; processing and refining the selection is a mental process that drawing a larger circle around the original selection that captures fewer right angles between selected voxels, resulting in an indication of a smoother contiguous group of selected voxels.
Doing all of this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform these steps within said environment.
Applying a computer to perform generic 3D modelling at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
Further, as to the applicant’s arguments about this voxel manipulation and generation not being a mental process because it “require{s} per-voxel gradient computations over hundreds of megabytes … determin{ing} "concave shapes" or "propagate a selection of contiguous voxels" across millions of cubelets in memory,” the ability to do this is merely a side effect of instructing a computer to apply this abstract idea. For example, a computer could calculate long division faster than a human could by hand writing out each step; this does not make this calculation any less of an abstract idea. See (MPEP 2106.05(f)(2): Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).)
Applicant argues that projecting the scene holographically makes the claims eligible as it requires “head-tracked wave-guide optics and spatial-mapping sensors” and “adjusting the projection as the surgeon moves”
Examiner responds by explaining that, given its broadest reasonable interpretation in view of the specification, such projection as claimed does not require such features. The claimed projection features, as in claim 1, 12, and 27 (i.e. projecting the plurality of three-dimensional scenes onto the user to guide an operator, wherein the projecting includes holographic projection; projecting, by holographic projection, the plurality of three-dimensional scenes onto the user to guide an operator, the holographic projection can be manipulated by the operator or can be positioned on the user) do not require any specific technology, let alone head-tracked wave-guide optics and spatial-mapping sensors and adjusting the projection as the surgeon moves; such a “holographic projection” could consist of anything from simply pointing a common projector at a sheet of transparent material, to a spinning LED array, to any number of other simple techniques. Note that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Similarly, the explicit use of a headset to display imagery as described in claim 20 merely specifies the type of output device.
“Manipulating” the projection could be as simple as moving the projector into place or pointing the headset in the right direction, and is therefore merely part of the insignificant post-solution activity.
As such, these limitations amount no more than insignificant post-solution activity.
Further, even if it were claimed, the tracking of the projection, i.e. altering the output of the projection so depicted imagery moves to a certain position, is merely the mental process of moving that imagery on a drawn image to a different position with a pencil and paper, as by observing and judging where such imagery should be positioned physically (i.e. observing an operating theater and judging where the patient’s legs are,) erasing the associated drawn imagery from its current position, and drawing it in a new position with a pencil and paper. This could be repeated over and over to “track” an object the person is observing on the drawing. Then, displaying these images on a projection device is merely the act of presenting the output of this mental process, i.e. insignificant post-solution activity.
Applicant argues that because the steps take place in a processor, they overcome the prior rejection.
Examiner responds by explaining that clarifying that the steps take place in a processor is equivalent to merely instructing a general purpose computer to perform the judicial exception steps.
As explained by MPEP 2106.05(f), “claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”
Applicant argues that transforming the raw image data into a model overcomes the prior rejection.
Examiner responds by explaining that such a transformation is a mental process equivalent to observing the image data and creating a model based on it, for example drawing such a model by using a pen and paper. Performing additional actions to this model such as simulating surgical acts and segmenting it by organ boundaries are just drawn modifications to the model, such as adding indications of incisions or splitting the model in perspective cubes to represent voxels.
(MPEP 2106.05(a)(I): An inventive concept "cannot be furnished by the unpatentable law of nature (or natural phenomenon or abstract idea) itself." Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016))
Performing such an operation on “raw medical imaging data,” and a “digital model,” by a “processor” is equivalent to instructing a general purpose computer to perform the judicial exception steps.
Applicant argues that using a network to send the imagery to a remote display overcomes the prior rejection
Examiner responds by firstly explaining that a final step displaying the imagery generated by the abstract process on a display is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Additionally, first sending this information over a network is an explicitly recognized example of mere instructions to apply an exception (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Further, should it be found that transmitting the information over a network is not an example of mere instructions to apply an exception, it is also explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network);)
Further the claims recite numerous mental processes, such as:
A method for surgical preparation and surgery, the method comprising: … constructing a digital model from the obtained medical imaging data, the digital model comprises a two-dimensional image representation or a three-dimensional image representation;
This is a mental process equivalent to observing the image data and creating a model based on it, for example drawing such a model by using a pen and paper.
Performing such an operation on “medical imaging data,” and a “digital model,” is equivalent to instructing a general purpose computer to perform the judicial exception steps.
generating a plurality of scenes by applying the sequence of surgical acts to the digital model;
Generating scenes is practical to perform by the human mind by drawing representations of those scenes with a pencil and paper.
Performing such an operation on a “digital model,” in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated scenes;
Simulating the performance of a sequence of surgical acts is practical to perform in the human mind, and is equivalent to drawing a series of images corresponding to steps in a surgery with a pencil and paper, showing the effect of each action on the surgical patient and the movement of the surgeon’s hands.
Performing such an operation on a “digital model,” in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere instructions to apply and mere data gathering
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements;
Generating a set of voxels for different types of tissues is a mental process equivalent to drawing perspective drawings of those tissues made of cubes, as with a pencil and paper. This kind of voxel drawing is occasionally done by children drawing their favorite characters from games like Minecraft.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment. See analysis under mere instructions to apply.
extracting, at the processor, the individual anatomical elements to form a selection of voxels; and
This is a mental process equivalent to identifying groups of voxels that represent an organ, for example, a person could observe a set of voxels representing different body parts and differentiate the skeleton from, for example, the stomach.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool.
Clipping these voxels is a mental process equivalent to identifying a selection of voxels as being selected by drawing an indication, such as a box, around the desired voxels with a pen and paper.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels;
Selecting contiguous voxels is equivalent to indicating that a set of neighboring voxels are selected, such as by drawing a circle around them with a pen and paper. Expanding or propagating this selection is merely the process of drawing a bigger circle that contains more voxels than the original selection.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
identifying concave shapes from the selection of voxels to delimit the articular surfaces;
Identifying concave shapes is a mental process equivalent to observing a shape and judging whether or not it is concave.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and
Identifying organ shapes is a mental process equivalent to observing a shape and judging whether or not it matches the known shape of an organ, such as the shape of the lungs or of wrist bones.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, and
Processing and refining the selection is a mental process that drawing a larger circle around the original selection that captures fewer right angles between selected voxels, resulting in an indication of a smoother contiguous group of selected voxels.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
extracting data of interest from the reconstructed digital model
Extracting data of interest is equivalent to observing a data and judging which pieces are significant, something practical to perform in the human mind.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
determining at least one pathology based on the extracted data of interest
Determining a pathology based on the data of interest is equivalent to observing the data and judging whether there is an issue or abnormality with the extracted data.
Response to Arguments-103
Applicant's arguments filed 10/08/2025 have been fully considered but they are not persuasive.
Applicant argues that no prior art teaches “performing, at the processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data”
Examiner responds by explaining that while this feature is not explicitly taught by the previously cited references, it is taught by new reference Casey (US 20200078180 A1)
In particular, Casey teaches performing, at the processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data ([Par 75-76] “The surgical assistance system 364 can perform a finite element analysis on a generated three-dimensional model (e.g., models of the spine, vertebrae, implants, etc.) to assess stresses, strains, deformation characteristics (e.g., load deformation characteristics), fracture characteristics (e.g., fracture toughness), fatigue life, etc. The surgical assistance system 364 can generate a three-dimensional mesh to analyze the model of the implant. Based on these results, the configuration of the implant can be varied based on one or more design criteria (e.g., maximum allowable stresses, fatigue life, etc.). Multiple models can be produced and analyzed to compare different types of implants, which can aid in the selection of a particular implant configuration… The surgical assistance system 364 can incorporate results from the analysis procedure in suggestions” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”)
Casey is analogous art because it is within the field of medical procedure planning. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez, Poltaretskyi, Star-lack before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better conform procedure design to each patient. As noted by Casey, many surgical procedures require implants, but these are usually in the form of generic, stock implants that may not optimally support the unique biology and injury/disease characteristics of every patient([Par 5] “he goal of interbody fusion is to grow bone between vertebra in order to seize the spatial relationships in a position that provides enough room for neural elements, including exiting nerve roots. An interbody implant device (or interbody implant, interbody cage, or fusion cage, or spine cage) is a prosthesis used in spinal fusion procedures to maintain relative position of vertebra and establish appropriate foraminal height and decompression of exiting nerves. Each patient may have individual or unique disease characteristics, but most implant solutions include implants (e.g. interbody implants) having standard sizes or shapes (stock implants).”[Par 26- 31] “Insufficient contact and load transfer between the vertebrae (anatomy) and the interbody implant (device) can produce inadequate fixation… If enough motion occurs, expulsion of the interbody implant or subsidence of the interbody implant into the adjacent vertebrae can result… Traditional implants are selected intraoperatively from a surgical kit containing likely sizes and shapes depending on the surgical approach and patient anatomy. Selection of implant size is performed by the surgeon during the surgery while the patient's spine is exposed. Often, minimal consideration is paid to implant size prior to the surgery… Even with the attention paid to the sagittal height, the implants available in surgery only come in stock sizes that are unlikely to provide optimal solutions for the particular patient or particular interbody space. Additionally, traditional stock implants do not provide any options for variable coronal angles. By selecting stock implants intraoperatively from a fixed assortment of implant sizes, the surgeon is unable to provide to the patient an optimal solution for correction of the particular spinal deformity or pathological malalignment causing patient pain… Furthermore, intraoperative selection of stock implants requires shipment and delivery of sufficient implants to cover the wide variety of patients and their unique interbody spaces. The shipping, sterilization, processing, and delivery of enough implants to surgery can be characterized as logistically burdensome and expensive. It is not uncommon for more than fifty implants to be delivered to a surgery that requires only one implant…. Improper or sub-optimal sizing of interbody implants can result in implant failures. If the interbody space is not sufficiently filled, posterior implants (including rods and plates) are required to carry more dynamic loads prior to fusion. The typical failure mode of spinal rods include fracture due to dynamic loads; the increased magnitude of the movement due to an undersized interbody implant only exacerbates the condition, leading to more implant failures.”) To this end, Casey presents a method for patient-specific implant system including predictions of implant performance ([Abstract] “A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.” [Par 32] “Patient-specific interbody implants can be designed for optimal fit in the negative space created by removal of the disc and adjustment of the relative position of vertebrae. Surgical planning software can be used to adjust the relative positions of vertebrae and define the negative space between the vertebrae. Modifying the spatial relationship between adjacent vertebrae within a virtual design space can provide a definition of the 3D negative space into which an interbody can be delivered. Software can further be used to compare the original pathology to the corrected positions of the vertebrae. The optimal size and shape of patient-specific implants can prevent or reduce instances of dynamic failure of posterior implants.” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”) Overall, one of ordinary skill in the art would have recognized that combining the patient-specific implant system of Casey with Giraldez, Poltaretskyi, Star-lack would result in a system that allows for optimal selection of implants during the surgical procedure including predictions of implant life, ultimately resulting in more reliable, long-lasting surgical outcomes.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-12, 16-20, 22-27, and 30 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.
Claims 1, 12, 20, and 27 recite the limitation " a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the patient, in order to use the physical integrity of the anatomical part of interest as input data;” There is insufficient antecedent basis for this limitation in the claim.
There are several antecedent basis issues with this limitation:
Firstly, no “patient” was previously introduced. This creates ambiguity leading to indefiniteness as it is unclear whether this refers to the “user” introduced earlier in the claims or if it is referring to another person. For the purposes of this examination, the “patient” and “user” are interpreted as referring to the same person.
No physical integrity was introduced previously in the claim; claim elements should not be introduced for the first time with the article “the.”
No “anatomical part of interest” was previously introduced. Further, this creates ambiguity leading to indefiniteness as it is unclear whether this refers to the “data of interest,” “elements of interest,” or is a separate entity all together. For the purposes of this examination, the “anatomical part of interest” is interpreted as referring to any anatomical element.
Claim Objections
Claims 1, 4-12, 16-20, 22-27, and 30 objected to because of the following informalities:
Claims 1, 12, 20, and 27 recite “the different types of elements of interest;” no different types of elements of interest were previously introduced. Claim elements should not be introduced for the first time with the article “the.” For example, this limitation could be correctly amended by changing its text to instead read “generating, at the processor, several voxels representing
Claim 20 recites the limitation “…projecting, via a headset based on instructions performing…” Because of the addition of the new claim language, i.e. “instructions performing a finite-element analysis,” it could be misinterpreted which performing step this is referring to. For the purposes of this examination, it is treated as if it refers to the voxel processing steps (i.e. clipping or selecting continuous voxels, identifying the concave shapes from the selection to delimit the articular surfaces, or shape recognizing or co-locating anatomical parts in order to predict whether a voxel or a selection of voxels belongs to an organic tissue) To clear up this intended ambiguity, it is recommended to amend the limitations of the claim to read something along the lines of “instructions performing at least one voxel selection manipulation of the following based on the identified individual anatomical elements:” and “instructions projecting, via a headset based on the instructions performing the at least on voxel selection manipulation, the generated images to guide an operator”
Claims 22-26 recite “The computer software of claim 20;” as claim 20 has been amended to no longer be computer software, this should instead read “The non-transitory computer-readable memory of claim 20.”
Appropriate correction is required.
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, 4-12, 16-20, 22-27, and 30 are rejected under 35 U.S.C. 101 because they are directed to an abstract idea without significantly more.
Claim 1 (Statutory Category – Process)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
reconstructing, at the processor, a digital model from the obtained raw medical imaging data, wherein the digital model comprises a two-dimensional image representation or a three-dimensional image representation;
This is a mental process equivalent to observing the image data and creating a model based on it, for example drawing such a model by using a pen and paper.
Performing such an operation on “raw medical imaging data,” and a “digital model,” by a “processor” is equivalent to instructing a general purpose computer to perform the judicial exception steps.
determining, at the processor, at least one pathology based on the digital model;
Determining a pathology based on the digital model is equivalent to observing the model and judge whether there is an issue or abnormality with the model.
Performing such an operation on a “digital model,” by a processor is equivalent to instructing a general purpose computer to perform the judicial exception steps.
generating, at the processor, a plurality of three-dimensional scenes by applying the sequence of surgical acts to the digital model;
Generating a plurality of three-dimensional scenes is practical to perform by the human mind by drawing three-dimensional representations of those scenes with a pencil and paper.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
simulating, at the processor, a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Simulating the performance of a sequence of surgical acts is practical to perform in the human mind, and is equivalent to drawing a series of images corresponding to steps in a surgery with a pencil and paper, showing the effect of each action on the surgical patient and the movement of the surgeon’s hands.
Performing such an operation on a “digital model,” in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere instructions to apply and mere data gathering
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements;
Generating a set of voxels for different types of tissues is a mental process equivalent to drawing perspective drawings of those tissues made of cubes, as with a pencil and paper. This kind of voxel drawing is occasionally done by children drawing their favorite characters from games like Minecraft.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
extracting, at the processor, the individual anatomical elements to form a selection of voxels; and
This is a mental process equivalent to identifying groups of voxels that represent an organ, for example, a person could observe a set of voxels representing different body parts and differentiate the skeleton from, for example, the stomach.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also mere data gathering.
performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels;
Selecting contiguous voxels is equivalent to indicating that a set of neighboring voxels are selected, such as by drawing a circle around them with a pen and paper. Expanding or propagating this selection is merely the process of drawing a bigger circle that contains more voxels than the original selection.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
identifying concave shapes from the selection of voxels to delimit the articular surfaces;
Identifying concave shapes is a mental process equivalent to observing a shape and judging whether or not it is concave.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and
Identifying organ shapes is a mental process equivalent to observing a shape and judging whether or not it matches the known shape of an organ, such as the shape of the lungs or of wrist bones.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure,
Processing and refining the selection is a mental process that drawing a larger circle around the original selection that captures fewer right angles between selected voxels, resulting in an indication of a smoother contiguous group of selected voxels.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
extracting data of interest from the reconstructed digital model;
Extracting data of interest is equivalent to observing a data and judging which pieces are significant, something practical to perform in the human mind.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
determining at least one pathology based on the extracted data of interest;
Determining a pathology based on the data of interest is equivalent to observing the data and judging whether there is an issue or abnormality with the extracted data.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
obtaining, at the processor, a sequence of surgical acts based on the at least one pathology;
Obtaining the sequence of surgical acts is merely the act of gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
simulating, at the processor, a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering.
extracting data of interest from the reconstructed digital model;
Extracting this data of interest from the model is merely the act of gathering data representative of such data of interest in a generic manner, and therefore amounts to no more than mere data gathering.
Post-Solution Activity:
… and displaying, on a display based on the step of performing, at least one of: the reconstructed digital model, the at least one pathology, the generated plurality of three-dimensional scenes, and the simulated virtual performance.
Displaying the imagery on a display is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
and projecting the plurality of three-dimensional scenes onto the user to guide an operator, wherein the projecting includes holographic projection.
Displaying the imagery by projecting it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A surgical support method, comprising: communicating raw medical imaging data corresponding to a user from a remote computing architecture to a memory associated with a processor through a network; storing the raw medical imaging data in the memory; … communicating through the network
Communicating data over a network by a processor and storing data in memory are explicitly recognized examples of mere instructions to apply an exception; See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”) As well as (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
simulating, at the processor, a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
performing, at the processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” reciting how simulation is actually accomplished.. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are insignificant extra-solution activity or mere instructions to apply and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
obtaining, at the processor, a sequence of surgical acts based on the at least one pathology;
Obtaining the sequence of surgical acts is merely the act of gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
simulating, at the processor, a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
extracting data of interest from the reconstructed digital model;
Extracting this data of interest from the model is merely the act of gathering data representative of such data of interest in a generic manner, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-Solution Activity:
… and displaying, on a display based on the step of performing, at least one of: the reconstructed digital model, the at least one pathology, the generated plurality of three-dimensional scenes, and the simulated virtual performance.
Displaying the imagery on a display is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
and projecting the plurality of three-dimensional scenes onto the user to guide an operator, wherein the projecting includes holographic projection.
Displaying the imagery by projecting it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A surgical support method, comprising: communicating raw medical imaging data corresponding to a user from a remote computing architecture to a memory associated with a processor through a network; storing the raw medical imaging data in the memory; … communicating through the network
Communicating data over a network by a processor and storing data in memory are explicitly recognized examples of mere instructions to apply an exception; See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”) As well as (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
simulating, at the processor, a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
performing, at the processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” without reciting how simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
Well-Understood, Routine, Conventional Activity (WURC) has found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept (MPEP 2106.05(d))
WURC:
A surgical support method, comprising: communicating raw medical imaging data corresponding to a user from a remote computing architecture to a memory associated with a processor through a network; communicating through the network
Transmitting data over a generic network is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network);)
storing the raw medical imaging data in the memory;
Storing data in memory is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93; )
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; … performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure
US 6496188 B1 ([Col 1 line 19-56])
US 20150003703 A1 ([Par 7, Par 28])
US 20170245825 A1 (i.e. Star-Lack) ([Par 22-31])
US 20080143718 A1 ([Par 8])
US 20200401843 A1 ([Par 1-8])
US 20070081710 A1 ([Par 1-12])
Moreover, the additional computer elements of claim 1 “raw medical imaging data, a remote computing architecture, a memory associated with a processor through a network, a digital model, virtual performance, voxels, reconstructed digital model” are rejected for simply applying a general purpose computer. (MPEP 2106.05(f))
Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 12 (Statutory Category – Machine)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
reconstructing, at the processor, a digital model from the obtained raw medical imaging data, wherein the digital model comprises a two-dimensional image representation or a three-dimensional image representation;
This is a mental process equivalent to observing the image data and creating a model based on it, for example drawing such a model by using a pen and paper.
Performing such an operation on “raw medical imaging data,” and a “digital model,” by a “processor” is equivalent to instructing a general purpose computer to perform the judicial exception steps.
extracting, at the processor, data of interest from the reconstructed digital model;
This is a mental process equivalent to identifying model portions that represent an organ, for example, a person could observe a region of the model representing different body parts and mentally differentiate the skeleton from, for example, the stomach.
Performing such an operation on a processor is equivalent to instructing a general purpose computer to perform the judicial exception steps.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
determining at least one pathology based on the extracted data of interest;
Determining a pathology based on the data of interest is equivalent to observing the data and judging whether there is an issue or abnormality with the extracted data.
generating a plurality of three-dimensional scenes by applying the sequence of surgical acts to the extracted data of interest;
Generating a plurality of three-dimensional scenes is practical to perform by the human mind by drawing three-dimensional representations of those scenes with a pencil and paper.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Simulating the performance of a sequence of surgical acts is practical to perform in the human mind, and is equivalent to drawing a series of images corresponding to steps in a surgery with a pencil and paper, showing the effect of each action on the surgical patient and the movement of the surgeon’s hands.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements;
Generating a set of voxels for different types of tissues is a mental process equivalent to drawing perspective drawings of those tissues made of cubes, as with a pencil and paper. This kind of voxel drawing is occasionally done by children drawing their favorite characters from games like Minecraft.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
extracting, at the processor, the individual anatomical elements to form a selection of voxels; and
This is a mental process equivalent to identifying groups of voxels that represent an organ, for example, a person could observe a set of voxels representing different body parts and differentiate the skeleton from, for example, the stomach.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, this is also an example of mere data gathering.
performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool.
Clipping these voxels is a mental process equivalent to identifying a selection of voxels as being selected by drawing an indication, such as a box, around the desired voxels with a pen and paper.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels;
Selecting contiguous voxels is equivalent to indicating that a set of neighboring voxels are selected, such as by drawing a circle around them with a pen and paper. Expanding or propagating this selection is merely the process of drawing a bigger circle that contains more voxels than the original selection.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
identifying concave shapes from the selection of voxels to delimit the articular surfaces;
Identifying concave shapes is a mental process equivalent to observing a shape and judging whether or not it is concave.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and
Identifying organ shapes is a mental process equivalent to observing a shape and judging whether or not it matches the known shape of an organ, such as the shape of the lungs or of wrist bones.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, and
Processing and refining the selection is a mental process that drawing a larger circle around the original selection that captures fewer right angles between selected voxels, resulting in an indication of a smoother contiguous group of selected voxels.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
obtaining, at the processor, raw medical imaging data corresponding to a user from the database;
Obtaining data from the database is merely the act of gathering data.
Further, should it be found that obtaining this data is not an example of mere data gathering, it is also part of the mere instructions to apply.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
extracting, at the processor, data of interest from the reconstructed digital model;
Extracting data “of interest” from the digital model in a generic manner is equivalent to merely gathering that data, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
obtaining a sequence of surgical acts based on the at least one pathology from the database;
Obtaining the sequence of surgical acts is merely gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-Solution Activity:
… and displaying, on a display based on the step of performing, at least one of: the reconstructed digital model, the at least one pathology, the generated plurality of three-dimensional scenes, and the simulated virtual performance;
Displaying the imagery on a display is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
projecting, by holographic projection, the plurality of three-dimensional scenes onto the user to guide an operator, the holographic projection can be manipulated by the operator or can be positioned on the user, and wherein the generated plurality of three-dimensional scenes or the simulated virtual performance is displayed in a collaborative mode to remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.
Displaying the imagery by projecting or otherwise displaying it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Specifying that the projection can be “manipulated” merely clarifies additional details of the projection. Such a manipulation might consist of, for example, moving the projector to ensure it was in the right place or pointing the headset in the right direction. Therefore, specifying this is merely an extension of the insignificant post-solution activity.
Transmitting the view remotely is an example of mere instructions to apply the judicial exception and WURC, as explained below.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A surgical support system, comprising: at least one processor and a memory coupled to the at least one processor, wherein the memory stores: a database including a set of raw medical imaging data and a set of surgical acts, wherein each set of raw medical imaging data corresponds to a user; and instructions executed by the at least one processor and wherein the instructions include: obtaining, at the processor, raw medical imaging data corresponding to a user from the database;
The use of generic computing components to perform an abstract process amounts to no more than mere instructions to apply. Further, storing and accessing data in memory is explicitly recognized by the courts as an example of mere instructions to apply. See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”)
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
performing, at the processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” without reciting how simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure;
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
communicating through the network; remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.
Communicating data over a network by a processor is an explicitly recognized example of mere instructions to apply an exception (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Further, should it be found that this element is not an example of mere instructions to apply an exception, it is also being Well-Understood, Routine, Conventional Activity
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are insignificant extra-solution activity or mere instructions to apply and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
obtaining, at the processor, raw medical imaging data corresponding to a user from the database;
Obtaining data from the database is merely the act of gathering data.
Further, should it be found that obtaining this data is not an example of mere data gathering, it is also part of the mere instructions to apply.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
extracting, at the processor, data of interest from the reconstructed digital model;
Extracting data “of interest” from the digital model in a generic manner is equivalent to merely gathering that data, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
obtaining a sequence of surgical acts based on the at least one pathology from the database;
Obtaining the sequence of surgical acts is merely gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-Solution Activity:
… and displaying, on a display based on the step of performing, at least one of: the reconstructed digital model, the at least one pathology, the generated plurality of three-dimensional scenes, and the simulated virtual performance.
Displaying the imagery on a display is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
projecting, by holographic projection, the plurality of three-dimensional scenes onto the user to guide an operator, the holographic projection can be manipulated by the operator or can be positioned on the user, and wherein the generated plurality of three-dimensional scenes or the simulated virtual performance is displayed in a collaborative mode to remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.
Displaying the imagery by projecting or otherwise displaying it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Specifying that the projection can be “manipulated” merely clarifies additional details of the projection. Such a manipulation might consist of, for example, moving the projector to ensure it was in the right place or pointing the headset in the right direction. Therefore, specifying this is merely an extension of the insignificant post-solution activity.
Transmitting the view remotely is an example of mere instructions to apply the judicial exception and WURC, as explained below.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A surgical support system, comprising: at least one processor and a memory coupled to the at least one processor, wherein the memory stores: a database including a set of raw medical imaging data and a set of surgical acts, wherein each set of raw medical imaging data corresponds to a user; and instructions executed by the at least one processor and wherein the instructions include: obtaining, at the processor, raw medical imaging data corresponding to a user from the database;
The use of generic computing components to perform an abstract process amounts to no more than mere instructions to apply. Further, storing, accessing, and retrieving data in memory is explicitly recognized by the courts as an example of mere instructions to apply. See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”)
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
Further, should it be found that this element is not an example of mere instructions to apply an exception, it is also being Well-Understood, Routine, Conventional Activity
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
performing, at the processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” without reciting how simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure;
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
communicating through the network; remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.
Communicating data over a network by a processor is an explicitly recognized example of mere instructions to apply an exception (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Further, should it be found that this element is not an example of mere instructions to apply an exception, it is also being Well-Understood, Routine, Conventional Activity
Well-Understood, Routine, Conventional Activity (WURC) has found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept (MPEP 2106.05(d))
WURC:
communicating through the network; remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.
Transmitting data over a generic network is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network);)
wherein the memory stores: a database including a set of raw medical imaging data and a set of surgical acts, wherein each set of raw medical imaging data corresponds to a user;
Storing data in memory is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93; )
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure;
US 6496188 B1 ([Col 1 line 19-56])
US 20150003703 A1 ([Par 7, Par 28])
US 20170245825 A1 (i.e. Star-Lack) ([Par 22-31])
US 20080143718 A1 ([Par 8])
US 20200401843 A1 ([Par 1-8])
US 20070081710 A1 ([Par 1-12])
Moreover, the additional computer elements of claim 12 “A surgical support system, comprising: at least one processor and a memory coupled to the at least one processor, wherein the memory stores: a database including a set of raw medical imaging data and a set of surgical acts, wherein each set of raw medical imaging data corresponds to a user; and instructions executed by the at least one processor and wherein the instructions include: …, at the processor, raw medical imaging data, a digital model, virtual performance, finite element analysis, voxels, displaying, on a display; the reconstructed digital model” are rejected for simply applying a general purpose computer. (MPEP 2106.05(f))
Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 20 (Statutory Category – Machine)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
instructions creating a digital model from the medical imaging data, the digital model comprises a two-dimensional image representation or a three-dimensional image representation;
This is a mental process equivalent to observing the image data and creating a model based on it, for example drawing such a model by using a pen and paper.
Performing such an operation on “medical imaging data,” and a “digital model,” is equivalent to instructing a general purpose computer to perform the judicial exception steps.
instructions using data of interest from the digital model;
This is a mental process equivalent to identifying model portions that represent an organ, for example, a person could observe a region of the model representing different body parts and differentiate the skeleton from, for example, the stomach.
Performing such an operation on a “digital model,” by a processor is equivalent to instructing a general purpose computer to perform the judicial exception steps.
instructions determining at least one pathology based on the data of interest;
Determining a pathology based on the data of interest is equivalent to observing the data and judging whether there is an issue or abnormality with the extracted data.
Performing such an operation on a computer by a processor is equivalent to instructing a general purpose computer to perform the judicial exception steps.
instructions generating a visual image by applying the sequence of surgical acts to the data of interest;
Generating visual images is practical to perform by the human mind by drawing representations of those images with a pencil and paper.
Performing such an operation on a computer by a processor is equivalent to instructing a general purpose computer to perform the judicial exception steps.
instructions simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated images;
Simulating the performance of a sequence of surgical acts is practical to perform in the human mind, and is equivalent to drawing a series of images corresponding to steps in a surgery with a pencil and paper, showing the effect of each action on the surgical patient and the movement of the surgeon’s hands.
Performing such an operation on a “digital model,” in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere instructions to apply and mere data gathering.
Instructions generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements;
Generating a set of voxels for different types of tissues is a mental process equivalent to drawing perspective drawings of those tissues made of cubes, as with a pencil and paper. This kind of voxel drawing is occasionally done by children drawing their favorite characters from games like Minecraft.
Performing such an operation in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels; and
This is a mental process equivalent to identifying groups of voxels that represent an organ, for example, a person could observe a set of voxels representing different body parts and differentiate the skeleton from, for example, the stomach.
Performing such an operation in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also mere data gathering.
Instructions performing, at the processor, at least one of the following based on the identified individual anatomical elements: instructions clipping voxels of an image from the selection of voxels using input from a tracing tool.
Clipping these voxels is a mental process equivalent to identifying a selection of voxels as being selected by drawing an indication, such as a box, around the desired voxels with a pen and paper.
Performing such an operation in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Instructions selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels;
Selecting contiguous voxels is equivalent to indicating that a set of neighboring voxels are selected, such as by drawing a circle around them with a pen and paper. Expanding or propagating this selection is merely the process of drawing a bigger circle that contains more voxels than the original selection.
Performing such an operation in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Instructions identifying concave shapes from the selection of voxels to delimit the articular surfaces;
Identifying concave shapes is a mental process equivalent to observing a shape and judging whether or not it is concave.
Performing such an operation in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Instructions shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and
Identifying organ shapes is a mental process equivalent to observing a shape and judging whether or not it matches the known shape of an organ, such as the shape of the lungs or of wrist bones.
Performing such an operation in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Instructions processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, and
Processing and refining the selection is a mental process that drawing a larger circle around the original selection that captures fewer right angles between selected voxels, resulting in an indication of a smoother contiguous group of selected voxels.
Performing such an operation in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
instructions receiving medical imaging data corresponding to a user from a database;
Receiving data from the database is merely the act of gathering data.
Further, should it be found that obtaining this data is not an example of mere data gathering, it is also part of the mere instructions to apply.
instructions receiving a sequence of surgical acts based on the at least one pathology;
Receiving the sequence of surgical acts is merely gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
instructions simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated images;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
Instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering.
Post-solution activity:
instructions projecting, via a headset based on instructions performing, the generated images to guide an operator … and displaying, on a display of the headset based on instructions projecting, at least one of: the digital model, the at least one pathology, the generated images, and the simulated virtual performance, wherein projecting includes projecting a holographic projection, and the holographic projection can be manipulated by the operator or can be positioned on the user. wherein projecting includes projecting a holographic projection, and the holographic projection can be manipulated by the operator or can be positioned on the user.
Displaying the imagery by projecting or otherwise displaying it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Specifying that the projection can be “manipulated” merely clarifies additional details of the projection. Such a manipulation might consist of, for example, moving the projector to ensure it was in the right place or pointing the headset in the right direction. Therefore, specifying this is merely an extension of the insignificant post-solution activity.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A non-transitory computer- readable memory, comprising instructions executable by a processor, the instructions comprising: instructions receiving medical imaging data corresponding to a user from a database;
The use of generic computing components to perform an abstract process amounts to no more than mere instructions to apply. Further, storing, accessing, and receiving data in memory is explicitly recognized by the courts as an example of mere instructions to apply. See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”)
instructions simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated images;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
instructions performing a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” without reciting how simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
instructions generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels; and instructions performing at least one of the following based on the identified individual anatomical elements: instructions clipping voxels of an image from the selection of voxels using input from a tracing tool; instructions selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; instructions identifying concave shapes from the selection of voxels to delimit the articular surfaces; instructions shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel or the selection of voxels belongs to an organic tissue; instructions processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure,
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
instructions communicating through the network
Communicating data over a network by a processor is an explicitly recognized example of mere instructions to apply an exception (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Further, should it be found that this element is not an example of mere instructions to apply an exception, it is also being Well-Understood, Routine, Conventional Activity
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are insignificant extra-solution activity or mere instructions to apply and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
instructions receiving medical imaging data corresponding to a user from a database;
Receiving data from the database is merely the act of gathering data.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Further, should it be found that obtaining this data is not an example of mere data gathering, it is also part of the mere instructions to apply.
instructions receiving a sequence of surgical acts based on the at least one pathology;
Receiving the sequence of surgical acts is merely gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
instructions simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated images;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
Instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-solution activity:
instructions projecting, via a headset based on instructions performing, the generated images to guide an operator … and displaying, on a display of the headset based on instructions projecting, at least one of: the digital model, the at least one pathology, the generated images, and the simulated virtual performance, wherein projecting includes projecting a holographic projection, and the holographic projection can be manipulated by the operator or can be positioned on the user. wherein projecting includes projecting a holographic projection, and the holographic projection can be manipulated by the operator or can be positioned on the user.
Displaying the imagery by projecting or otherwise displaying it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Specifying that the projection can be “manipulated” merely clarifies additional details of the projection. Such a manipulation might consist of, for example, moving the projector to ensure it was in the right place or pointing the headset in the right direction. Therefore, specifying this is merely an extension of the insignificant post-solution activity.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A non-transitory computer- readable memory, comprising instructions executable by a processor, the instructions comprising: instructions receiving medical imaging data corresponding to a user from a database;
The use of generic computing components to perform an abstract process amounts to no more than mere instructions to apply. Further, storing, accessing, and receiving data in memory is explicitly recognized by the courts as an example of mere instructions to apply. See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”)
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
instructions simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated images;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
instructions performing a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” without reciting how simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
instructions generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels; and instructions performing at least one of the following based on the identified individual anatomical elements: instructions clipping voxels of an image from the selection of voxels using input from a tracing tool; instructions selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; instructions identifying concave shapes from the selection of voxels to delimit the articular surfaces; instructions shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel or the selection of voxels belongs to an organic tissue; instructions processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure,
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
instructions communicating through the network
Communicating data over a network by a processor is an explicitly recognized example of mere instructions to apply an exception (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Further, should it be found that this element is not an example of mere instructions to apply an exception, it is also being Well-Understood, Routine, Conventional Activity
Well-Understood, Routine, Conventional Activity (WURC) has found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept (MPEP 2106.05(d))
WURC:
A non-transitory computer- readable memory, comprising instructions executable by a processor, the instructions comprising: instructions receiving medical imaging data corresponding to a user from a database;
Transmitting data over a generic network is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network);)
Storing data in memory is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93; )
instructions generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels; and instructions performing at least one of the following based on the identified individual anatomical elements: instructions clipping voxels of an image from the selection of voxels using input from a tracing tool; instructions selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; instructions identifying concave shapes from the selection of voxels to delimit the articular surfaces; instructions shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel or the selection of voxels belongs to an organic tissue;
US 6496188 B1 ([Col 1 line 19-56])
US 20150003703 A1 ([Par 7, Par 28])
US 20170245825 A1 (i.e. Star-Lack) ([Par 22-31])
US 20080143718 A1 ([Par 8])
US 20200401843 A1 ([Par 1-8])
US 20070081710 A1 ([Par 1-12])
Moreover, the additional computer elements of claim 20 “A non-transitory computer- readable memory, comprising instructions executable by a processor, the instructions comprising: instructions…, medical imaging data corresponding to a user from a database; a digital model, at the processor, virtual performance, voxels, a headset, displaying, on a display” are rejected for simply applying a general purpose computer. (MPEP 2106.05(f))
Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 27 (Statutory Category – Process)
Step 2A – Prong 1: Judicial Exception Recited?
Yes, the claim recites a mental process, specifically:
A method for surgical preparation and surgery, the method comprising: … constructing a digital model from the obtained medical imaging data, the digital model comprises a two-dimensional image representation or a three-dimensional image representation;
This is a mental process equivalent to observing the image data and creating a model based on it, for example drawing such a model by using a pen and paper.
Performing such an operation on “medical imaging data,” and a “digital model,” is equivalent to instructing a general purpose computer to perform the judicial exception steps.
generating a plurality of scenes by applying the sequence of surgical acts to the digital model;
Generating scenes is practical to perform by the human mind by drawing representations of those scenes with a pencil and paper.
Performing such an operation on a “digital model,” in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated scenes;
Simulating the performance of a sequence of surgical acts is practical to perform in the human mind, and is equivalent to drawing a series of images corresponding to steps in a surgery with a pencil and paper, showing the effect of each action on the surgical patient and the movement of the surgeon’s hands.
Performing such an operation on a “digital model,” in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere instructions to apply and mere data gathering
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements;
Generating a set of voxels for different types of tissues is a mental process equivalent to drawing perspective drawings of those tissues made of cubes, as with a pencil and paper. This kind of voxel drawing is occasionally done by children drawing their favorite characters from games like Minecraft.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment. See analysis under mere instructions to apply.
extracting, at the processor, the individual anatomical elements to form a selection of voxels; and
This is a mental process equivalent to identifying groups of voxels that represent an organ, for example, a person could observe a set of voxels representing different body parts and differentiate the skeleton from, for example, the stomach.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool.
Clipping these voxels is a mental process equivalent to identifying a selection of voxels as being selected by drawing an indication, such as a box, around the desired voxels with a pen and paper.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels;
Selecting contiguous voxels is equivalent to indicating that a set of neighboring voxels are selected, such as by drawing a circle around them with a pen and paper. Expanding or propagating this selection is merely the process of drawing a bigger circle that contains more voxels than the original selection.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
identifying concave shapes from the selection of voxels to delimit the articular surfaces;
Identifying concave shapes is a mental process equivalent to observing a shape and judging whether or not it is concave.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and
Identifying organ shapes is a mental process equivalent to observing a shape and judging whether or not it matches the known shape of an organ, such as the shape of the lungs or of wrist bones.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, and
Processing and refining the selection is a mental process that drawing a larger circle around the original selection that captures fewer right angles between selected voxels, resulting in an indication of a smoother contiguous group of selected voxels.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
extracting data of interest from the reconstructed digital model
Extracting data of interest is equivalent to observing a data and judging which pieces are significant, something practical to perform in the human mind.
Doing this in a true 3D environment using a processor is merely the act of instructing a general purpose computer to perform this step within said environment.
Should it be found that this is not a mental process, it is also an example of mere data gathering.
determining at least one pathology based on the extracted data of interest
Determining a pathology based on the data of interest is equivalent to observing the data and judging whether there is an issue or abnormality with the extracted data.
Step 2A – Prong 2: Integrated into a Practical Solution?
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
obtaining medical imaging data corresponding to a user;
Obtaining data from the database is merely the act of gathering data.
Further, should it be found that obtaining this data is not an example of mere data gathering, it is also part of the mere instructions to apply.
selecting a sequence of surgical acts from a database;
Receiving the sequence of surgical acts is merely gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated scenes;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering.
extracting data of interest from the reconstructed digital model;
Extracting this data of interest from the model is merely the act of gathering data representative of such data of interest in a generic manner, and therefore amounts to no more than mere data gathering.
Post-solution activity:
displaying at least one of: the reconstructed digital model, the generated plurality of scenes, and the simulated virtual performance; showing the plurality of scenes to guide surgical preparation and surgery associated with the user by projecting a holographic projection, and the holographic projection can be manipulated by the operator or can be positioned on the user.
Displaying the imagery by projecting or otherwise displaying it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Specifying that the projection can be “manipulated” merely clarifies additional details of the projection. Such a manipulation might consist of, for example, moving the projector to ensure it was in the right place or pointing the headset in the right direction. Therefore, specifying this is merely an extension of the insignificant post-solution activity.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A method for surgical preparation and surgery, the method comprising: obtaining medical imaging data corresponding to a user; … selecting a sequence of surgical acts from a database;
Communicating data over a network by a processor and storing, accessing, and retrieving data in memory are explicitly recognized examples of mere instructions to apply an exception; See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”) As well as (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated scenes;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
performing, at a processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” without reciting how simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure;
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
communicating through the network
Communicating data over a network by a processor is an explicitly recognized example of mere instructions to apply an exception (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Further, should it be found that this element is not an example of mere instructions to apply an exception, it is also being Well-Understood, Routine, Conventional Activity
Step 2B: Claim provides an Inventive Concept?
No, as discussed with respect to Step 2A, the additional limitations are insignificant extra-solution activity or mere instructions to apply and do not impose any meaningful limits on practicing the abstract idea and therefore the claim does not provide an inventive concept in Step 2B.
Insignificant Extra-Solution Activity (MPEP 2106.05(g)) has found mere data gathering and
post solution activity to be insignificant extra-solution activity.
Data gathering:
obtaining medical imaging data corresponding to a user;
Obtaining data from the database is merely the act of gathering data.
Further, should it be found that obtaining this data is not an example of mere data gathering, it is also part of the mere instructions to apply.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
selecting a sequence of surgical acts from a database;
Receiving the sequence of surgical acts is merely gathering data representing those surgical acts. As stated by the specification, this sequence is obtained from a database ([Par 15] “…selecting a sequence of surgical acts from a database”)
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated scenes;
Obtaining the output of such a simulation recited at such a high level or generality amounts to no more than steps to generically gather data representative of said output (i.e. the virtual performance sequence) and therefore amounts to no more than mere data gathering.
Should it be found that this is not an example of mere data gathering, it is also an example of mere instructions to apply.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
extracting, at the processor, the individual anatomical elements to form a selection of voxels;
Extracting this data in a generic manner is merely equivalent to gathering data representative of that selection of voxels, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
extracting data of interest from the reconstructed digital model;
Extracting this data of interest from the model is merely the act of gathering data representative of such data of interest in a generic manner, and therefore amounts to no more than mere data gathering.
A claim element that amounts to merely gathering data is not indicative of integration into a
practical solution nor evidence that the claim provides an inventive concept or significantly more, as exemplified by ((MPEP 2106.05)(g)(Mere Data Gathering) i. Performing clinical tests on individuals to obtain input for an equation, In re Grams, 888 F.2d 835, 839-40; 12 USPQ2d 1824, 1827-28 (Fed. Cir. 1989); iv. Obtaining information about transactions using the Internet to verify credit card transactions, CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011);
Post-solution activity:
displaying at least one of: the reconstructed digital model, the generated plurality of scenes, and the simulated virtual performance; showing the plurality of scenes to guide surgical preparation and surgery associated with the user by projecting a holographic projection, and the holographic projection can be manipulated by the operator or can be positioned on the user.
Displaying the imagery by projecting or otherwise displaying it is merely the act of presenting the result of the previous abstract steps. A claim element that merely acts on a series of previous abstract steps is not indicative of integration into a practical solution nor evidence that the claim provides an inventive concept, as exemplified by ((MPEP 2106.05)(g)(Insignificant application) i. Cutting hair after first determining the hair style, In re Brown, 645 Fed. App'x 1014, 1016-1017 (Fed. Cir. 2016) and ii. Printing or downloading generated menus, Ameranth, 842 F.3d at 1241-42, 120 USPQ2d at 1854-55.)
Specifying that the projection can be “manipulated” merely clarifies additional details of the projection. Such a manipulation might consist of, for example, moving the projector to ensure it was in the right place or pointing the headset in the right direction. Therefore, specifying this is merely an extension of the insignificant post-solution activity.
Mere Instructions to Apply (MPEP 2106.05(f)) has found that merely applying a judicial exception such as an abstract idea, as by performing it on a computer, does not integrate the claim into a practical solution.
Mere Instructions to Apply:
A method for surgical preparation and surgery, the method comprising: obtaining medical imaging data corresponding to a user;… selecting a sequence of surgical acts from a database;
Communicating data over a network by a processor and storing, accessing, and receiving data in memory are explicitly recognized examples of mere instructions to apply an exception; See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”) As well as (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated scenes;
Applying a computer to perform a generic simulation at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that simulation, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the virtual performance is “simulated” without reciting how this simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
performing, at a processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Applying a computer to perform generic finite element analysis at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that analysis, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the analysis is “performed” and stresses/deformations are “simulated” without reciting how simulation is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure;
Applying a computer to perform generic 3D modelling with voxels at a high level of generality is simply the act of instructing a computer to perform generic functions to perform that modelling, which is merely an instruction to apply a computer to the judicial exception. The claim only recites the idea of a solution or outcome, i.e. that the voxels are “generated,” elements are “extracted” to form selections, and those selections are adjusted without reciting how this voxel generation and selection is actually accomplished. Further, the computer elements claimed are cited as merely generic tools to perform the operations.
The courts have found that such mere instructions to apply are not indicative of integration into a practical application nor recitation of significantly more than the judicial exception (MPEP 2106.05(f) “Another consideration when determining whether a claim integrates a judicial exception into a practical application in Step 2A Prong Two or recites significantly more than a judicial exception in Step 2B is whether the additional elements amount to more than a recitation of the words "apply it" (or an equivalent) or are more than mere instructions to implement an abstract idea or other exception on a computer. As explained by the Supreme Court, in order to make a claim directed to a judicial exception patent-eligible, the additional element or combination of elements must do "‘more than simply stat[e] the [judicial exception] while adding the words ‘apply it’". Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965). Thus, for example, claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. Alice Corp., 573 U.S. at 223, 110 USPQ2d at 1983”)
communicating through the network
Communicating data over a network by a processor is an explicitly recognized example of mere instructions to apply an exception (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Further, should it be found that this element is not an example of mere instructions to apply an exception, it is also being Well-Understood, Routine, Conventional Activity
Well-Understood, Routine, Conventional Activity (WURC) has found that claim elements that are understood to be Well-Understood, Routine, Conventional Activity are not indicative of Integration into a Practical Solution nor evidence of an Inventive Concept (MPEP 2106.05(d))
WURC:
A method for surgical preparation and surgery, the method comprising: obtaining medical imaging data corresponding to a user; selecting a sequence of surgical acts from a database;
Transmitting data over a generic network is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network);)
Storing data in memory is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) iv. Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93; )
generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure;
US 6496188 B1 ([Col 1 line 19-56])
US 20150003703 A1 ([Par 7, Par 28])
US 20170245825 A1 (i.e. Star-Lack) ([Par 22-31])
US 20080143718 A1 ([Par 8])
US 20200401843 A1 ([Par 1-8])
US 20070081710 A1 ([Par 1-12])
Moreover, the additional computer elements of claim 27 “medical imaging data, a digital model, a database, at the processor, virtual performance, voxels, displaying, the reconstructed digital model” are rejected for simply applying a general purpose computer. (MPEP 2106.05(f))
Mere Instructions To Apply An Exception (MPEP 2106.05(f)) has found that simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more.
The additional elements have been considered both individually and as an ordered combination in the consideration of whether they constitute significantly more, and have been determined not to constitute such.
The claim is ineligible.
Claim 4 recites “the holographic projection can be manipulated by the operator or can be positioned on the user.”
This claim merely specifies additional aspects of the post-solution activity, and is therefore merely post-solution activity itself.
Claim 5 recites “the generated plurality of three- dimensional scenes or the simulated virtual performance is displayed in a collaborative mode to remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.”
This claim merely specifies additional aspects of the post-solution activity, and is therefore merely post-solution activity itself. Further, communicating said data is an example of mere instructions to apply and well-understood, routine, conventional activity.
See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”) As well as (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Transmitting data over a generic network is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network);)
Claim 6 recites “implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model the simulated virtual performance.”
Using numerical mathematic modeling to model something is inherently a mathematic concept. Using generic artificial intelligence model is also merely utilizing a very complicated algorithm, which is therefore also a mathematic concept.
Claim 7 recites “generating second digital models of at least one of: anatomical elements, implantable medical devices, and ancillary instrumentation corresponding to the sequence of surgical acts, wherein the second digital models include three-dimensional objects based on the reconstructed digital model or data of interest extracted from the reconstructed digital model.”
Generating models based on other models or objects is a mental process that practical to perform in the human mind, as by observing a first mode or object l and drawing a representation of it with a pencil and paper.
Claim 8 recites “wherein the anatomical elements, the implantable medical devices, or the ancillary instrumentation are based on anatomy of the user”
This merely specifies the form the anatomical elements, the implantable medical devices, or the ancillary instrumentation are to take, and is therefore merely an extension of the mental process of generating models of them.
Claim 9 recites “projecting the second digital models onto the user to guide an operator, wherein the projecting includes holographic projection”
Projecting the models after generating them is a form of presenting the results of the previous steps, and is therefore merely post-solution activity
Claim 10 recites “in response to a structured surgical planning of the user ending, generating second digital models of at least one of: anatomical elements, implantable medical devices, and ancillary instrumentation.”
Generating models of something is a mental process equivalent to drawing a representation of that thing with a pencil and paper.
Claim 11 recites “generating a digital file based on the second digital models”
Generating a digital file of a model is equivalent to storing a file representation of that model. This is an example of Well-Understood, Routine, Conventional Activity. See MPEP 2106.05(d)(II)(iv) [Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;]
Claim 11 also recites “and transmitting the generated digital file to a manufacturing facility to create a three- dimensional model using the generated digital file.”
Transmitting digital data generically without specifying the mechanism by which it is transmitted has been determined by the courts to be an example of Mere Instructions To Apply An Exception. See MPEP 2106.05(f)(1)(iii) [Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).]
Claim 16 recites “implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model the simulated virtual performance.”
Using numerical mathematic modeling to model something is inherently a mathematic concept. Using generic artificial intelligence model is also merely utilizing a very complicated algorithm, which is therefore also a mathematic concept.
Claim 17 recites “generating second digital models of at least one of: anatomical elements, implantable medical devices, and ancillary instrumentation corresponding to the sequence of surgical acts, wherein the device digital models include three-dimensional objects based on the reconstructed digital model or the extracted data of interest.”
Generating models based on other models or objects is a mental process that practical to perform in the human mind, as by observing a first mode or object l and drawing a representation of it with a pencil and paper.
Claim 18 recites “wherein the anatomical elements, the implantable medical devices, or the ancillary instrumentation are based on anatomy of the user.”
This merely specifies the form the anatomical elements, the implantable medical devices, or the ancillary instrumentation are to take, and is therefore merely an extension of the mental process of generating models of them.
Claim 19 recites “projecting the second digital models onto the user to guide an operator, wherein the projecting includes holographic projection.”
Projecting the models after generating them is a form of presenting the results of the previous steps, and is therefore merely post-solution activity.
Claim 22 recites “wherein the generated images or the simulated virtual performance is displayed in a collaborative mode to remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.”
This claim merely specifies additional aspects of the post-solution activity, and is therefore merely post-solution activity itself. Further, communicating said data is an example of mere instructions to apply and well-understood, routine, conventional activity.
See (MPEP 2106.05(f)(2) “Whether the claim invokes computers or other machinery merely as a tool to perform an existing process. Use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Similarly, "claiming the improved speed or efficiency inherent with applying the abstract idea on a computer" does not integrate a judicial exception into a practical application or provide an inventive concept. Intellectual Ventures I LLC v. Capital One Bank (USA), 792 F.3d 1363, 1367, 115 USPQ2d 1636, 1639 (Fed. Cir. 2015).”) As well as (MPEP 2106.05(f)(1) i. Remotely accessing user-specific information through a mobile interface and pointers to retrieve the information without any description of how the mobile interface and pointers accomplish the result of retrieving previously inaccessible information, Intellectual Ventures v. Erie Indem. Co., 850 F.3d 1315, 1331, 121 USPQ2d 1928, 1939 (Fed. Cir. 2017); iii. Wireless delivery of out-of-region broadcasting content to a cellular telephone via a network without any details of how the delivery is accomplished, Affinity Labs of Texas v. DirecTV, LLC, 838 F.3d 1253, 1262-63, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016).)
Transmitting data over a generic network is explicitly recognized by the courts as being Well-Understood, Routine, Conventional Activity ((MPEP 2106.05(d)(II) i. Receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network);)
Claim 23 recites “instructions implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model the simulated virtual performance.”
Using numerical mathematic modeling to model something is inherently a mathematic concept. Using generic artificial intelligence model is also merely utilizing a very complicated algorithm, which is therefore also a mathematic concept.
Claim 24 recites “instructions second device digital models of at least one of: anatomical elements, implantable medical devices, and ancillary instrumentation corresponding to the sequence of surgical acts, wherein the second digital models include three-dimensional objects based on the reconstructed digital model or the data of interest.”
Generating models based on other models or objects is a mental process that practical to perform in the human mind, as by observing a first mode or object l and drawing a representation of it with a pencil and paper.
Claim 25 recites “wherein the anatomical elements, the implantable medical devices, or the ancillary instrumentation are based on anatomy of the user.”
This merely specifies the form the anatomical elements, the implantable medical devices, or the ancillary instrumentation are to take, and is therefore merely an extension of the mental process of generating models of them.
Claim 26 recites “instructions projecting the second digital models onto the user to guide the operator, wherein the projecting includes holographic projection.”
Projecting the models after generating them is a form of presenting the results of the previous steps, and is therefore merely post-solution activity
Claim 30 recites “implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model the simulated virtual performance.”
Using numerical mathematic modeling to model something is inherently a mathematic concept. Using generic artificial intelligence model is also merely utilizing a very complicated algorithm, which is therefore also a mathematic concept.
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, 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.
Claims 1, 4-12, 16-20, 22-27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Giraldez (US 20210228276 A1) in view of Poltaretskyi (US 20190380792 A1) in further view of Star-lack (US 20170245825 A1) as well as Casey (US 20200078180 A1)
Claim 1. Giraldez makes obvious A surgical support method, comprising: communicating raw medical imaging data corresponding to a user ([Par 101] “ In some embodiments, the diagnostic AI 307 may ingest patient raw data 301 and patient images 302 to generate a prediction about the appropriate timing for future procedures.” [Par 97] “The patient raw data 301 and patient images 302 received from the patient are then uploaded to the data analytics service 303 and diagnostic AI 307 components of the server system. The data analytics service processes the patient raw data 301 to generate patient analytics results 304,”) from a remote computing architecture to a memory associated with a processor through a network; ([Par 124] “ In one embodiment, a processor (e.g., a specialized graphics processor) in the server computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.” [Par 73] “The sever system 120 components include a communications module 124 that provides a connection to a wireless service 127 as well as a network connection” [Par 23] “ In one embodiment, the patient information includes at least one image of the patient's body;”) [Examiner’s note: it would be obvious to one of ordinary skill in the art that a server communicating with a database would involve communicating with a memory associated with a processor] storing the raw medical imaging data in the memory; ([Par 103] “In some embodiments, the database of patient images 302 and videos may be specific to particular procedures and products used in procedures. The database of patient images 302 may be associated with timestamp information describing a date and time a procedure was performed and a time period between administering a particular product. The augmented database of patient images 302 and raw patient data 301 may be used to train the diagnostic AI 307”) reconstructing, at the processor, a digital model from the obtained raw medical imaging data, wherein the digital model comprises a two-dimensional image representation or a three-dimensional image representation; ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) [Examiner’s note: the “three-dimensional image representation” is interpreted as a three-dimensional representation of the image, i.e. a 3D model generated from said imagery] determining, at the processor, at least one pathology based on the digital model; ([Par 49] “The patient follow-up and consent aspect of the software application further includes one or more machine learning models or artificial intelligence systems for diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body. The diagnosis may be based on automated image classification results informed by real world diagnostic methodology from surgeons.”) obtaining, at the processor, a sequence of surgical acts (Par 124] “ … computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.” [Par 33] “The location and effect of any incisions, injections, substance removal, application of a product, suturing, or any other physical manipulation made by the doctor during the procedure will be visualized on a representation of the patient's actual body. These models and simulation allow the patient and physician to visualize the effect each step of the procedure will have on the patient's body in advance of the performing the procedure”) based on the at least one pathology; ([Par 49] “… the software application further includes … diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body.”) generating, at the processor, a plurality of three-dimensional scenes by applying the sequence of surgical acts to the digital model; ([Par 32] “ For example, the computer system provides a procedure simulation by comparing a pre-operative 3D model generated before the procedure to one or more 3D post-operative models. … One or more post-operative models are then generated by the computer system based on a set of input parameters such as patient demographics, type of procedure, desired simulation time intervals, physician performing the procedure, and the products and/or product brands used in the procedure. … The post-operative models depict changes to the patient's body that occur as a result of the procedure. In one example, the changes are shown through a series of post-operative models depicting one or more intermediate steps ... the post-operative models may depict changes to the patient's body that occur as a result of actions by the physician during the procedure.”) simulating, at the processor, a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes; ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.” [Par 67] “Another example includes a transformational simulation depicting every step of a surgical or non-surgical procedure.”) ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) ([Par 111] “Procedure simulations may be saved for record keeping purposes or shared by the patient to one or more social networks.”) ([Par 19] “creating a 3D model of at least a part of the patient's body that would be affected by the procedure; using a first predictive model, generating a first modified 3D model of the at least part of the patient's body following the procedure, simulating the effects of the procedure as performed by a first physician;” [Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” {the reconstructed digital model) extracting data of interest from the reconstructed digital model; ([Par 118] “ Regarding hair replacement, this e-learning platform and consent and follow-up application includes the option to generate a 3D model of the patient's head using a number of photos or a 3D scanning device, then provide with the required simulation and planning tools to perform hair transplantation. The system auto-detects the areas from the 3D model with hair and without.”) determining the at least one pathology ([Par 49] “The patient follow-up and consent aspect of the software application further includes one or more machine learning models or artificial intelligence systems for diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body. The diagnosis may be based on automated image classification results informed by real world diagnostic methodology from surgeons.”) based on the extracted data of interest; ([Par 118] “ Regarding hair replacement, this e-learning platform and consent and follow-up application includes the option to generate a 3D model of the patient's head using a number of photos or a 3D scanning device, then provide with the required simulation and planning tools to perform hair transplantation. The system auto-detects the areas from the 3D model with hair and without.”) [Examiner’s note: determining the pathology “based on the extracted data of interest” is just choosing to determine the pathology in the area of interest. In this case it would be determining such diagnoses and possible complications for a hair transplant] and projecting the plurality of three-dimensional scenes onto the user ([Par 32] “The post-operative models depict changes to the patient's body that occur as a result of the procedure. In one example, the changes are shown through a series of post-operative models depicting one or more intermediate steps ... the post-operative models may depict changes to the patient's body that occur as a result of actions by the physician during the procedure.” [Par 35] “ ... In this example, users can change the position of the 3D model or simulation by moving his or her physical body. The system automatically detects the body part to be augmented, projects a virtual image of the body part with the effects of the procedure onto the actual body part, tracks the actual body part in real time, and changes the angle and perspective of the projected virtual image of the changed body part according to real time changes in the position of the actual body part.”)
Giraldez fails to make obvious performing, at the processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, displaying, on a display; projecting information to guide an operator, wherein the projecting includes holographic projection.
Poltaretskyi makes obvious , displaying, on a display ([Par 358] A screen through which the surgeon views the actual, real anatomy and also observes the virtual objects, such as virtual anatomy and/or virtual surgical guidance…”) projecting information to guide an operator, ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,” [Par 165] “…MR device that includes see-through holographic lenses, sometimes referred to as waveguides, that permit a user to view real-world objects through the lens and concurrently view projected 3D holographic objects.”) wherein the projecting includes holographic projection. ([Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”)
Poltaretskyi is analogous art because it is within the field of augmented reality and simulation as applied to surgical procedures. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination to create a system with enhanced collaborative features. As stated by Poltaretskyi, ([Par 2] “Many times, a surgical joint repair procedure, such as joint arthroplasty as an example, involves replacing the damaged joint with a prosthetic that is implanted into the patient's bone. Proper selection of a prosthetic that is appropriately sized and shaped and proper positioning of that prosthetic to ensure an optimal surgical outcome can be challenging.”) Surgery is an extremely delicate art in which the life of a patient is routinely on the line. This difficulty is further exasperated when further designing and implanting prosthetic devices Frequently, the acting surgeon may not be the best person suited to designing a specific prosthetic, or that surgeon may not have specialized knowledge of the specific patient or procedure they are performing. To alleviate these issue, Poltaretskyi presents a mixed reality powered collaborative system that allows a surgeon to consult with colleagues and get expert options from anywhere in the world on various aspects of the current operation that the surgeon may need assistance with. ([Par 726] “The remote physician using VR can watch the process in real time, provide feedback, and decide whether the process or step has been performed properly by the local surgeon.”) One of ordinary skill in the art would have recognized that combining the features of Poltaretskyi with those of Giraldez would produce a system that allows for sophisticated collaboration between surgeons and other medical professionals, ensuring a patient always gets the best care possible.
The combination of Giraldez and Poltaretskyi fails to make obvious performing, at the processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure
Star-lack makes obvious generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; ([Par 22] “In some embodiments, the dose-estimation system 130 may further discretize/partition the CT volume 210 into a set of 3D cells (or “voxels”).” [Par 25] “In some embodiments, the auto-segmentation module 220 may perform the feature-based segmentation operation based on the image density Hounsfield Unit (HU) values presented in the CT volume 210. Specifically, the auto-segmentation module 220 may evaluate the HU gradient of the voxels in CT volume 210. Using previously-defined HU value thresholds and density ranges, the auto-segmentation module 220 may identify structures in the CT volume 210 that have distinctive features. Each identified structure may then be classified, based on its respective HU values, to either non-organ materials (such as air, water), or organ regions (such as lung, adipose, soft-tissue, muscle or bone).”)extracting, at the processor, the individual anatomical elements to form a selection of voxels; ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) and performing, at the processor, at least one of the following based on the identified individual anatomical elements: selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, ([Par 31] “The auto-segmentation module 220 may use an optical flow equation to iteratively calculate the demons force as voxel displacement vectors. The voxel displacement vectors may then be regularized with the Gaussian function, and used to propagate the best-matching expert case's organ boundaries onto the current case, thereby refining the organ boundaries for the current case.” [Par 23] “After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) [Examiner’s note: this limitation is written in the alternate form; therefore, unmapped elements are not given patentable weight]
Star-lack is analogous art because it is within the field of medical image processing. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez and Poltaretskyi before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to automatically identify and separate organs in medical imagery. Although medical imaging is frequently performed with a target organ in mind, isolating that organ in the imagery can be a complex task, as typical medical imaging techniques commonly capture entire regions, such as the chest, legs, head, etc. as a consequence of their principles of operation. For example, it would be exceedingly difficult to capture an X-ray image of the bladder without the intestines, the lungs without the heart, etc. Distinguishing these organs from each other usually requires the expertise of a trained professional. This complexity if further compounded when evaluating three-dimensional imagery, such as that produced by successive computer tomography (CT) scans. One of ordinary skill in the art would have recognized the usefulness of a system capable of performing this identification automatically, allowing individual organs to be investigated separate of their surroundings. To this end, Star-lack presents a system capable of automatically segmenting three-dimensional medical imagery into separate subsets of 3D imagery that represent a single, isolated organ ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) Overall, one of ordinary skill in the art would have recognized that this combination of Star-lack with Giraldez and Poltaretskyi would produce a system capable of automatically processing and separating raw medical imagery into detailed models of individual organs, allowing the simulation of the procedure’s effects on those individual organs to be investigated in more detail.
The combination of Giraldez, Poltaretskyi, and Star-lack does not explicitly teach performing, at the processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Casey makes obvious performing, at the processor, a finite-element analysis of at least one of the digital model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data ([Par 75-76] “The surgical assistance system 364 can perform a finite element analysis on a generated three-dimensional model (e.g., models of the spine, vertebrae, implants, etc.) to assess stresses, strains, deformation characteristics (e.g., load deformation characteristics), fracture characteristics (e.g., fracture toughness), fatigue life, etc. The surgical assistance system 364 can generate a three-dimensional mesh to analyze the model of the implant. Based on these results, the configuration of the implant can be varied based on one or more design criteria (e.g., maximum allowable stresses, fatigue life, etc.). Multiple models can be produced and analyzed to compare different types of implants, which can aid in the selection of a particular implant configuration… The surgical assistance system 364 can incorporate results from the analysis procedure in suggestions” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”)
Casey is analogous art because it is within the field of medical procedure planning. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez, Poltaretskyi, Star-lack before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better conform procedure design to each patient. As noted by Casey, many surgical procedures require implants, but these are usually in the form of generic, stock implants that may not optimally support the unique biology and injury/disease characteristics of every patient([Par 5] “he goal of interbody fusion is to grow bone between vertebra in order to seize the spatial relationships in a position that provides enough room for neural elements, including exiting nerve roots. An interbody implant device (or interbody implant, interbody cage, or fusion cage, or spine cage) is a prosthesis used in spinal fusion procedures to maintain relative position of vertebra and establish appropriate foraminal height and decompression of exiting nerves. Each patient may have individual or unique disease characteristics, but most implant solutions include implants (e.g. interbody implants) having standard sizes or shapes (stock implants).”[Par 26- 31] “Insufficient contact and load transfer between the vertebrae (anatomy) and the interbody implant (device) can produce inadequate fixation… If enough motion occurs, expulsion of the interbody implant or subsidence of the interbody implant into the adjacent vertebrae can result… Traditional implants are selected intraoperatively from a surgical kit containing likely sizes and shapes depending on the surgical approach and patient anatomy. Selection of implant size is performed by the surgeon during the surgery while the patient's spine is exposed. Often, minimal consideration is paid to implant size prior to the surgery… Even with the attention paid to the sagittal height, the implants available in surgery only come in stock sizes that are unlikely to provide optimal solutions for the particular patient or particular interbody space. Additionally, traditional stock implants do not provide any options for variable coronal angles. By selecting stock implants intraoperatively from a fixed assortment of implant sizes, the surgeon is unable to provide to the patient an optimal solution for correction of the particular spinal deformity or pathological malalignment causing patient pain… Furthermore, intraoperative selection of stock implants requires shipment and delivery of sufficient implants to cover the wide variety of patients and their unique interbody spaces. The shipping, sterilization, processing, and delivery of enough implants to surgery can be characterized as logistically burdensome and expensive. It is not uncommon for more than fifty implants to be delivered to a surgery that requires only one implant…. Improper or sub-optimal sizing of interbody implants can result in implant failures. If the interbody space is not sufficiently filled, posterior implants (including rods and plates) are required to carry more dynamic loads prior to fusion. The typical failure mode of spinal rods include fracture due to dynamic loads; the increased magnitude of the movement due to an undersized interbody implant only exacerbates the condition, leading to more implant failures.”) To this end, Casey presents a method for patient-specific implant system including predictions of implant performance ([Abstract] “A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.” [Par 32] “Patient-specific interbody implants can be designed for optimal fit in the negative space created by removal of the disc and adjustment of the relative position of vertebrae. Surgical planning software can be used to adjust the relative positions of vertebrae and define the negative space between the vertebrae. Modifying the spatial relationship between adjacent vertebrae within a virtual design space can provide a definition of the 3D negative space into which an interbody can be delivered. Software can further be used to compare the original pathology to the corrected positions of the vertebrae. The optimal size and shape of patient-specific implants can prevent or reduce instances of dynamic failure of posterior implants.” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”) Overall, one of ordinary skill in the art would have recognized that combining the patient-specific implant system of Casey with Giraldez, Poltaretskyi, Star-lack would result in a system that allows for optimal selection of implants during the surgical procedure including predictions of implant life, ultimately resulting in more reliable, long-lasting surgical outcomes.
Claim 12. Giraldez makes obvious A surgical support system, comprising: at least one processor ([Par 124] “In one embodiment, a processor (e.g., a specialized graphics processor) in the server computer system…”) and a memory coupled to the at least one processor, wherein the memory stores: ([Par 92] “Signed consent forms, consent recordings, and questionnaire responses obtained from patients may be stored in the data storage module 240 for future reference.”) a database including a set of raw medical imaging data and a set of surgical acts, wherein each set of raw medical imaging data corresponds to a user; ([Par 124] “ In one embodiment, a processor (e.g., a specialized graphics processor) in the server computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.” [Par 23] “ In one embodiment, the patient information includes at least one image of the patient's body;”) and instructions executed by the at least one processor ([Par 124] “In one embodiment, a processor (e.g., a specialized graphics processor) in the server computer system…”) and wherein the instructions include: obtaining, at the processor, raw medical imaging data corresponding to a user ([Par 101] “ In some embodiments, the diagnostic AI 307 may ingest patient raw data 301 and patient images 302 to generate a prediction about the appropriate timing for future procedures.”) from the database; ([Par 124] “ In one embodiment, a processor (e.g., a specialized graphics processor) in the server computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.”) reconstructing, at the processor, a digital model from the obtained raw medical imaging data, wherein the digital model is comprises a two-dimensional image representation or a three-dimensional image representation; ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) [Examiner’s note: the “three-dimensional image representation” is interpreted as a three-dimensional representation of the image, i.e. a 3D model generated from said imagery] extracting, at the processor, data of interest ([Par 118] “ Regarding hair replacement, this e-learning platform and consent and follow-up application includes the option to generate a 3D model of the patient's head using a number of photos or a 3D scanning device, then provide with the required simulation and planning tools to perform hair transplantation. The system auto-detects the areas from the 3D model with hair and without.”) from the reconstructed digital model; ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans”)determining at least one pathology ([Par 49] “The patient follow-up and consent aspect of the software application further includes one or more machine learning models or artificial intelligence systems for diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body. The diagnosis may be based on automated image classification results informed by real world diagnostic methodology from surgeons.”) based on the extracted data of interest; ([Par 118] “The system auto-detects the areas from the 3D model with hair and without.”) obtaining a sequence of surgical acts (Par 124] “ … computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.” [Par 33] “The location and effect of any incisions, injections, substance removal, application of a product, suturing, or any other physical manipulation made by the doctor during the procedure will be visualized on a representation of the patient's actual body. These models and simulation allow the patient and physician to visualize the effect each step of the procedure will have on the patient's body in advance of the performing the procedure”) based on the at least one pathology ([Par 49] “… the software application further includes … diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body.”) from the database; ([Par 124] “ … computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.”) generating a plurality of three-dimensional scenes by applying the sequence of surgical acts ([Par 32] “ For example, the computer system provides a procedure simulation by comparing a pre-operative 3D model generated before the procedure to one or more 3D post-operative models. … One or more post-operative models are then generated by the computer system based on a set of input parameters such as patient demographics, type of procedure, desired simulation time intervals, physician performing the procedure, and the products and/or product brands used in the procedure. … The post-operative models depict changes to the patient's body that occur as a result of the procedure. In one example, the changes are shown through a series of post-operative models depicting one or more intermediate steps ... the post-operative models may depict changes to the patient's body that occur as a result of actions by the physician during the procedure.”) to the extracted data of interest; ([Par 118] “The system auto-detects the areas from the 3D model with hair and without.”) simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated plurality of three-dimensional scenes; ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body. [Par 67] “Another example includes a transformational simulation depicting every step of a surgical or non-surgical procedure.”) ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) ([Par 111] “Procedure simulations may be saved for record keeping purposes or shared by the patient to one or more social networks.”)([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.” [Par 67] “Another example includes a transformational simulation depicting every step of a surgical or non-surgical procedure.”) at least one of: the reconstructed digital model, the at least one pathology, the generated plurality of three-dimensional scenes, and the simulated virtual performance. ([Par 19] “creating a 3D model of at least a part of the patient's body that would be affected by the procedure; using a first predictive model, generating a first modified 3D model of the at least part of the patient's body following the procedure, simulating the effects of the procedure as performed by a first physician;” [Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” {the reconstructed digital model) projecting, ([Par 32] “The post-operative models depict changes to the patient's body that occur as a result of the procedure. In one example, the changes are shown through a series of post-operative models depicting one or more intermediate steps ... the post-operative models may depict changes to the patient's body that occur as a result of actions by the physician during the procedure.” [Par 35] “…In this example, users can change the position of the 3D model or simulation by moving his or her physical body. The system automatically detects the body part to be augmented, projects a virtual image of the body part with the effects of the procedure onto the actual body part, tracks the actual body part in real time, and changes the angle and perspective of the projected virtual image of the changed body part according to real time changes in the position of the actual body part.”) ([Par 35] “The system automatically detects the body part to be augmented, projects a virtual image of the body part with the effects of the procedure onto the actual body part, tracks the actual body part in real time, and changes the angle and perspective of the projected virtual image of the changed body part according to real time changes in the position of the actual body part.”) and wherein the generated plurality of three-dimensional scenes or the simulated virtual performance([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body”)
Giraldez fails to make obvious performing, at the processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the patient, in order to use the physical integrity of the anatomical part of interest as input data; generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure, displaying, on a display; projecting, by holographic projection, information to guide an operator, the holographic projection being holographic; information is displayed in a collaborative mode to remotely assist the operator to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode.
Poltaretskyi makes obvious ([Par 358] A screen through which the surgeon views the actual, real anatomy and also observes the virtual objects, such as virtual anatomy and/or virtual surgical guidance…”) projecting, by holographic projection, information to guide an operator, the holographic projection being holographic ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,” [Par 165] “…MR device that includes see-through holographic lenses, sometimes referred to as waveguides, that permit a user to view real-world objects through the lens and concurrently view projected 3D holographic objects.” [Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”) information is displayed in a collaborative mode to ([Par 733] “ As mentioned elsewhere in this disclosure, an MR system can include multiple visualization devices so that multiple users can simultaneously see the same images and share the same 3D scene, such as MR intraoperative guidance content 1802 (FIG. 18)”) remotely assist the operator ([Par 732] “in another yet example, an MR system that includes both MR and remote users (such as VR users or users that have display screens that display the MR views of others) may be used to facilitate emergency care. In this case, a remote user may be leveraged to assist an MR user with emergency care via an MR system.) to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode. ([Par 754] “ In still other examples, MR systems may allow for educational training during a medical procedure or surgery. That is to say, one or more passive viewers to the procedure may have passive MR visualization devices that provide the user with a view of the MR environment without any control over the MR environment. Such passive viewers may be located in the operating room, or in a viewing room adjacent the operating room, or remotely from the operating room.”)
Poltaretskyi is analogous art because it is within the field of augmented reality and simulation as applied to surgical procedures. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination to create a system with enhanced collaborative features. As stated by Poltaretskyi, ([Par 2] “Many times, a surgical joint repair procedure, such as joint arthroplasty as an example, involves replacing the damaged joint with a prosthetic that is implanted into the patient's bone. Proper selection of a prosthetic that is appropriately sized and shaped and proper positioning of that prosthetic to ensure an optimal surgical outcome can be challenging.”) Surgery is an extremely delicate art in which the life of a patient is routinely on the line. This difficulty is further exasperated when further designing and implanting prosthetic devices Frequently, the acting surgeon may not be the best person suited to designing a specific prosthetic, or that surgeon may not have specialized knowledge of the specific patient or procedure they are performing. To alleviate these issue, Poltaretskyi presents a mixed reality powered collaborative system that allows a surgeon to consult with colleagues and get expert options from anywhere in the world on various aspects of the current operation that the surgeon may need assistance with. ([Par 726] “The remote physician using VR can watch the process in real time, provide feedback, and decide whether the process or step has been performed properly by the local surgeon.”) One of ordinary skill in the art would have recognized that combining the features of Poltaretskyi with those of Giraldez would produce a system that allows for sophisticated collaboration between surgeons and other medical professionals, ensuring a patient always gets the best care possible.
The combination of Giraldez and Poltaretskyi fails to make obvious performing, at the processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the patient, in order to use the physical integrity of the anatomical part of interest as input data; generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure
Star-lack makes obvious generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; ([Par 22] “In some embodiments, the dose-estimation system 130 may further discretize/partition the CT volume 210 into a set of 3D cells (or “voxels”).” [Par 25] “In some embodiments, the auto-segmentation module 220 may perform the feature-based segmentation operation based on the image density Hounsfield Unit (HU) values presented in the CT volume 210. Specifically, the auto-segmentation module 220 may evaluate the HU gradient of the voxels in CT volume 210. Using previously-defined HU value thresholds and density ranges, the auto-segmentation module 220 may identify structures in the CT volume 210 that have distinctive features. Each identified structure may then be classified, based on its respective HU values, to either non-organ materials (such as air, water), or organ regions (such as lung, adipose, soft-tissue, muscle or bone).”) extracting, at the processor, the individual anatomical elements to form a selection of voxels; ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure ([Par 31] “The auto-segmentation module 220 may use an optical flow equation to iteratively calculate the demons force as voxel displacement vectors. The voxel displacement vectors may then be regularized with the Gaussian function, and used to propagate the best-matching expert case's organ boundaries onto the current case, thereby refining the organ boundaries for the current case.” [Par 23] “After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) [Examiner’s note: this limitation is written in the alternate form; therefore, unmapped elements are not given patentable weight]
Star-lack is analogous art because it is within the field of medical image processing. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez and Poltaretskyi before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to automatically identify and separate organs in medical imagery. Although medical imaging is frequently performed with a target organ in mind, isolating that organ in the imagery can be a complex task, as typical medical imaging techniques commonly capture entire regions, such as the chest, legs, head, etc. as a consequence of their principles of operation. For example, it would be exceedingly difficult to capture an X-ray image of the bladder without the intestines, the lungs without the heart, etc. Distinguishing these organs from each other usually requires the expertise of a trained professional. This complexity if further compounded when evaluating three-dimensional imagery, such as that produced by successive computer tomography (CT) scans. One of ordinary skill in the art would have recognized the usefulness of a system capable of performing this identification automatically, allowing individual organs to be investigated separate of their surroundings. To this end, Star-lack presents a system capable of automatically segmenting three-dimensional medical imagery into separate subsets of 3D imagery that represent a single, isolated organ ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) Overall, one of ordinary skill in the art would have recognized that this combination of Star-lack with Giraldez and Poltaretskyi would produce a system capable of automatically processing and separating raw medical imagery into detailed models of individual organs, allowing the simulation of the procedure’s effects on those individual organs to be investigated in more detail.
The combination of Giraldez, Poltaretskyi, and Star-lack does not explicitly teach performing, at the processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Casey makes obvious performing, at the processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data ([Par 75-76] “The surgical assistance system 364 can perform a finite element analysis on a generated three-dimensional model (e.g., models of the spine, vertebrae, implants, etc.) to assess stresses, strains, deformation characteristics (e.g., load deformation characteristics), fracture characteristics (e.g., fracture toughness), fatigue life, etc. The surgical assistance system 364 can generate a three-dimensional mesh to analyze the model of the implant. Based on these results, the configuration of the implant can be varied based on one or more design criteria (e.g., maximum allowable stresses, fatigue life, etc.). Multiple models can be produced and analyzed to compare different types of implants, which can aid in the selection of a particular implant configuration… The surgical assistance system 364 can incorporate results from the analysis procedure in suggestions” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”)
Casey is analogous art because it is within the field of medical procedure planning. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez, Poltaretskyi, Star-lack before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better conform procedure design to each patient. As noted by Casey, many surgical procedures require implants, but these are usually in the form of generic, stock implants that may not optimally support the unique biology and injury/disease characteristics of every patient([Par 5] “he goal of interbody fusion is to grow bone between vertebra in order to seize the spatial relationships in a position that provides enough room for neural elements, including exiting nerve roots. An interbody implant device (or interbody implant, interbody cage, or fusion cage, or spine cage) is a prosthesis used in spinal fusion procedures to maintain relative position of vertebra and establish appropriate foraminal height and decompression of exiting nerves. Each patient may have individual or unique disease characteristics, but most implant solutions include implants (e.g. interbody implants) having standard sizes or shapes (stock implants).”[Par 26- 31] “Insufficient contact and load transfer between the vertebrae (anatomy) and the interbody implant (device) can produce inadequate fixation… If enough motion occurs, expulsion of the interbody implant or subsidence of the interbody implant into the adjacent vertebrae can result… Traditional implants are selected intraoperatively from a surgical kit containing likely sizes and shapes depending on the surgical approach and patient anatomy. Selection of implant size is performed by the surgeon during the surgery while the patient's spine is exposed. Often, minimal consideration is paid to implant size prior to the surgery… Even with the attention paid to the sagittal height, the implants available in surgery only come in stock sizes that are unlikely to provide optimal solutions for the particular patient or particular interbody space. Additionally, traditional stock implants do not provide any options for variable coronal angles. By selecting stock implants intraoperatively from a fixed assortment of implant sizes, the surgeon is unable to provide to the patient an optimal solution for correction of the particular spinal deformity or pathological malalignment causing patient pain… Furthermore, intraoperative selection of stock implants requires shipment and delivery of sufficient implants to cover the wide variety of patients and their unique interbody spaces. The shipping, sterilization, processing, and delivery of enough implants to surgery can be characterized as logistically burdensome and expensive. It is not uncommon for more than fifty implants to be delivered to a surgery that requires only one implant…. Improper or sub-optimal sizing of interbody implants can result in implant failures. If the interbody space is not sufficiently filled, posterior implants (including rods and plates) are required to carry more dynamic loads prior to fusion. The typical failure mode of spinal rods include fracture due to dynamic loads; the increased magnitude of the movement due to an undersized interbody implant only exacerbates the condition, leading to more implant failures.”) To this end, Casey presents a method for patient-specific implant system including predictions of implant performance ([Abstract] “A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.” [Par 32] “Patient-specific interbody implants can be designed for optimal fit in the negative space created by removal of the disc and adjustment of the relative position of vertebrae. Surgical planning software can be used to adjust the relative positions of vertebrae and define the negative space between the vertebrae. Modifying the spatial relationship between adjacent vertebrae within a virtual design space can provide a definition of the 3D negative space into which an interbody can be delivered. Software can further be used to compare the original pathology to the corrected positions of the vertebrae. The optimal size and shape of patient-specific implants can prevent or reduce instances of dynamic failure of posterior implants.” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”) Overall, one of ordinary skill in the art would have recognized that combining the patient-specific implant system of Casey with Giraldez, Poltaretskyi, Star-lack would result in a system that allows for optimal selection of implants during the surgical procedure including predictions of implant life, ultimately resulting in more reliable, long-lasting surgical outcomes.
Claim 20. Giraldez makes obvious A non-transitory computer- readable memory, comprising instructions executable by a processor, the instructions comprising: ([Par 28] “In general, aspects and embodiments of the present invention include a software application for improving three core aspects of the patient medical experience” [Par 92] “Signed consent forms, consent recordings, and questionnaire responses obtained from patients may be stored in the data storage module 240 for future reference.”) instructions receiving medical imaging data corresponding to a user ([Par 101] “ In some embodiments, the diagnostic AI 307 may ingest patient raw data 301 and patient images 302 to generate a prediction about the appropriate timing for future procedures.”) from a database ([Par 124] “ In one embodiment, a processor (e.g., a specialized graphics processor) in the server computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.” [Par 23] “ In one embodiment, the patient information includes at least one image of the patient's body;”); instructions creating a digital model from the medical imaging data, the digital model comprises a two-dimensional image representation or a three-dimensional image representation; ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) [Examiner’s note: the “three-dimensional image representation” is interpreted as a three-dimensional representation of the image, i.e. a 3D model generated from said imagery] instructions using data of interest ([Par 118] “ Regarding hair replacement, this e-learning platform and consent and follow-up application includes the option to generate a 3D model of the patient's head using a number of photos or a 3D scanning device, then provide with the required simulation and planning tools to perform hair transplantation. The system auto-detects the areas from the 3D model with hair and without.”) from the digital model; ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.”) instructions determining at least one pathology ([Par 49] “The patient follow-up and consent aspect of the software application further includes one or more machine learning models or artificial intelligence systems for diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body. The diagnosis may be based on automated image classification results informed by real world diagnostic methodology from surgeons.”) based on the data of interest; ([Par 118] “ Regarding hair replacement, this e-learning platform and consent and follow-up application includes the option to generate a 3D model of the patient's head using a number of photos or a 3D scanning device, then provide with the required simulation and planning tools to perform hair transplantation. The system auto-detects the areas from the 3D model with hair and without.”) instructions receiving a sequence of surgical acts (Par 124] “ … computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001.” [Par 33] “The location and effect of any incisions, injections, substance removal, application of a product, suturing, or any other physical manipulation made by the doctor during the procedure will be visualized on a representation of the patient's actual body. These models and simulation allow the patient and physician to visualize the effect each step of the procedure will have on the patient's body in advance of the performing the procedure”) based on the at least one pathology; ([Par 49] “The patient follow-up and consent aspect of the software application further includes one or more machine learning models or artificial intelligence systems for diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body. The diagnosis may be based on automated image classification results informed by real world diagnostic methodology from surgeons.”) instructions generating a visual image by applying the sequence of surgical acts to the data of interest; ([Par 78] “In this example, the imaging engine 215 overlays the virtual model over the 2D photograph or digital image to augment the appearance of the photographed body part with a virtual representation of the desired procedure impacts, complication, or recovery effects.”) instructions simulating a virtual performance of the sequence of surgical acts on the digital model of the user ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.” [Par 67] “Another example includes a transformational simulation depicting every step of a surgical or non-surgical procedure.”) using the generated images; ([Par 38]In one example, the tool generates a 2D/3D model of at least one body part or anatomical region. [Par 78] “In this example, the imaging engine 215 overlays the virtual model over the 2D photograph or digital image to augment the appearance of the photographed body part with a virtual representation of the desired procedure impacts, complication, or recovery effects.”) ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.” [Par 67] “Another example includes a transformational simulation depicting every step of a surgical or non-surgical procedure.”) the generated images ([Par 38] In one example, the tool generates a 2D/3D model of at least one body part or anatomical region. [Par 78] “In this example, the imaging engine 215 overlays the virtual model over the 2D photograph or digital image to augment the appearance of the photographed body part with a virtual representation of the desired procedure impacts, complication, or recovery effects.”) ([Par 111] “Procedure simulations may be saved for record keeping purposes or shared by the patient to one or more social networks.”) at least one of: the digital model, the at least one pathology, the generated images, and the simulated virtual performance. ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” {the digital model}) wherein projecting includes projecting ([Par 35] “The system automatically detects the body part to be augmented, projects a virtual image of the body part with the effects of the procedure onto the actual body part, tracks the actual body part in real time, and changes the angle and perspective of the projected virtual image of the changed body part according to real time changes in the position of the actual body part.”)
Giraldez fails to make obvious instructions performing a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; instructions generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels; and instructions performing at least one of the following based on the identified individual anatomical elements: instructions clipping voxels of an image from the selection of voxels using input from a tracing tool; instructions selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; instructions identifying concave shapes from the selection of voxels to delimit the articular surfaces; instructions shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel or the selection of voxels belongs to an organic tissue; and instructions processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, instructions projecting, via a headset, to guide an operator; displaying, on a display of the headset, based on instructions projecting, wherein projecting includes projecting a holographic projection, and the holographic projection is holographic
Poltaretskyi makes obvious instructions projecting, via a headset, ([Par 358] “A screen through which the surgeon views the actual, real anatomy and also observes the virtual objects, such as virtual anatomy and/or virtual surgical guidance, may include one or more see-through holographic lenses. The holographic lenses, sometimes referred to as “waveguides,” may permit the user to view real-world objects through the lenses and display projected holographic objects for viewing by the user As discussed above, an example of a suitable head-mounted MR device for visualization device 213 is the Microsoft HOLOLENS headset, available from Microsoft Corporation, of Redmond, Wash., USA.”) images to guide an operator; ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,”) and instructions displaying, on a display of the headset, based on instructions projecting ([Par 358] “A screen through which the surgeon views the actual, real anatomy and also observes the virtual objects, such as virtual anatomy and/or virtual surgical guidance, may include one or more see-through holographic lenses … an example of a suitable head-mounted MR device for visualization device 213 is the Microsoft HOLOLENS headset) wherein projecting includes projecting a holographic projection, and the holographic projection is holographic ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,” [Par 165] “…MR device that includes see-through holographic lenses, sometimes referred to as waveguides, that permit a user to view real-world objects through the lens and concurrently view projected 3D holographic objects.” [Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”)
Poltaretskyi is analogous art because it is within the field of augmented reality and simulation as applied to surgical procedures. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination to create a system with enhanced collaborative features. As stated by Poltaretskyi, ([Par 2] “Many times, a surgical joint repair procedure, such as joint arthroplasty as an example, involves replacing the damaged joint with a prosthetic that is implanted into the patient's bone. Proper selection of a prosthetic that is appropriately sized and shaped and proper positioning of that prosthetic to ensure an optimal surgical outcome can be challenging.”) Surgery is an extremely delicate art in which the life of a patient is routinely on the line. This difficulty is further exasperated when further designing and implanting prosthetic devices Frequently, the acting surgeon may not be the best person suited to designing a specific prosthetic, or that surgeon may not have specialized knowledge of the specific patient or procedure they are performing. To alleviate these issue, Poltaretskyi presents a mixed reality powered collaborative system that allows a surgeon to consult with colleagues and get expert options from anywhere in the world on various aspects of the current operation that the surgeon may need assistance with. ([Par 726] “The remote physician using VR can watch the process in real time, provide feedback, and decide whether the process or step has been performed properly by the local surgeon.”) One of ordinary skill in the art would have recognized that combining the features of Poltaretskyi with those of Giraldez would produce a system that allows for sophisticated collaboration between surgeons and other medical professionals, ensuring a patient always gets the best care possible.
The combination of Giraldez and Poltaretskyi fails to make obvious instructions performing a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; instructions generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels; and instructions performing at least one of the following based on the identified individual anatomical elements: instructions clipping voxels of an image from the selection of voxels using input from a tracing tool; instructions selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; instructions identifying concave shapes from the selection of voxels to delimit the articular surfaces; instructions shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel or the selection of voxels belongs to an organic tissue; and instructions processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure,
Star-lack makes obvious instructions generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; ([Par 22] “In some embodiments, the dose-estimation system 130 may further discretize/partition the CT volume 210 into a set of 3D cells (or “voxels”).” [Par 25] “In some embodiments, the auto-segmentation module 220 may perform the feature-based segmentation operation based on the image density Hounsfield Unit (HU) values presented in the CT volume 210. Specifically, the auto-segmentation module 220 may evaluate the HU gradient of the voxels in CT volume 210. Using previously-defined HU value thresholds and density ranges, the auto-segmentation module 220 may identify structures in the CT volume 210 that have distinctive features. Each identified structure may then be classified, based on its respective HU values, to either non-organ materials (such as air, water), or organ regions (such as lung, adipose, soft-tissue, muscle or bone).”) instructions extracting, at the processor, the individual anatomical elements to form a selection of voxels; ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) and instructions performing at least one of the following based on the identified individual anatomical elements: instructions clipping voxels of an image from the selection of voxels using input from a tracing tool; instructions selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; instructions identifying concave shapes from the selection of voxels to delimit the articular surfaces; instructions shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel or the selection of voxels belongs to an organic tissue; and instructions processing and refining the selection of voxels with smoothing or correction operations of a three-dimensional structure, ([Par 31] “The auto-segmentation module 220 may use an optical flow equation to iteratively calculate the demons force as voxel displacement vectors. The voxel displacement vectors may then be regularized with the Gaussian function, and used to propagate the best-matching expert case's organ boundaries onto the current case, thereby refining the organ boundaries for the current case.” [Par 23] “After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”)
Star-lack is analogous art because it is within the field of medical image processing. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez and Poltaretskyi before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to automatically identify and separate organs in medical imagery. Although medical imaging is frequently performed with a target organ in mind, isolating that organ in the imagery can be a complex task, as typical medical imaging techniques commonly capture entire regions, such as the chest, legs, head, etc. as a consequence of their principles of operation. For example, it would be exceedingly difficult to capture an X-ray image of the bladder without the intestines, the lungs without the heart, etc. Distinguishing these organs from each other usually requires the expertise of a trained professional. This complexity if further compounded when evaluating three-dimensional imagery, such as that produced by successive computer tomography (CT) scans. One of ordinary skill in the art would have recognized the usefulness of a system capable of performing this identification automatically, allowing individual organs to be investigated separate of their surroundings. To this end, Star-lack presents a system capable of automatically segmenting three-dimensional medical imagery into separate subsets of 3D imagery that represent a single, isolated organ ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) Overall, one of ordinary skill in the art would have recognized that this combination of Star-lack with Giraldez and Poltaretskyi would produce a system capable of automatically processing and separating raw medical imagery into detailed models of individual organs, allowing the simulation of the procedure’s effects on those individual organs to be investigated in more detail.
The combination of Giraldez, Poltaretskyi, and Star-lack does not explicitly teach instructions performing a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Casey makes obvious instructions performing a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; ([Par 75-76] “The surgical assistance system 364 can perform a finite element analysis on a generated three-dimensional model (e.g., models of the spine, vertebrae, implants, etc.) to assess stresses, strains, deformation characteristics (e.g., load deformation characteristics), fracture characteristics (e.g., fracture toughness), fatigue life, etc. The surgical assistance system 364 can generate a three-dimensional mesh to analyze the model of the implant. Based on these results, the configuration of the implant can be varied based on one or more design criteria (e.g., maximum allowable stresses, fatigue life, etc.). Multiple models can be produced and analyzed to compare different types of implants, which can aid in the selection of a particular implant configuration… The surgical assistance system 364 can incorporate results from the analysis procedure in suggestions” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”)
Casey is analogous art because it is within the field of medical procedure planning. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez, Poltaretskyi, Star-lack before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better conform procedure design to each patient. As noted by Casey, many surgical procedures require implants, but these are usually in the form of generic, stock implants that may not optimally support the unique biology and injury/disease characteristics of every patient([Par 5] “he goal of interbody fusion is to grow bone between vertebra in order to seize the spatial relationships in a position that provides enough room for neural elements, including exiting nerve roots. An interbody implant device (or interbody implant, interbody cage, or fusion cage, or spine cage) is a prosthesis used in spinal fusion procedures to maintain relative position of vertebra and establish appropriate foraminal height and decompression of exiting nerves. Each patient may have individual or unique disease characteristics, but most implant solutions include implants (e.g. interbody implants) having standard sizes or shapes (stock implants).”[Par 26- 31] “Insufficient contact and load transfer between the vertebrae (anatomy) and the interbody implant (device) can produce inadequate fixation… If enough motion occurs, expulsion of the interbody implant or subsidence of the interbody implant into the adjacent vertebrae can result… Traditional implants are selected intraoperatively from a surgical kit containing likely sizes and shapes depending on the surgical approach and patient anatomy. Selection of implant size is performed by the surgeon during the surgery while the patient's spine is exposed. Often, minimal consideration is paid to implant size prior to the surgery… Even with the attention paid to the sagittal height, the implants available in surgery only come in stock sizes that are unlikely to provide optimal solutions for the particular patient or particular interbody space. Additionally, traditional stock implants do not provide any options for variable coronal angles. By selecting stock implants intraoperatively from a fixed assortment of implant sizes, the surgeon is unable to provide to the patient an optimal solution for correction of the particular spinal deformity or pathological malalignment causing patient pain… Furthermore, intraoperative selection of stock implants requires shipment and delivery of sufficient implants to cover the wide variety of patients and their unique interbody spaces. The shipping, sterilization, processing, and delivery of enough implants to surgery can be characterized as logistically burdensome and expensive. It is not uncommon for more than fifty implants to be delivered to a surgery that requires only one implant…. Improper or sub-optimal sizing of interbody implants can result in implant failures. If the interbody space is not sufficiently filled, posterior implants (including rods and plates) are required to carry more dynamic loads prior to fusion. The typical failure mode of spinal rods include fracture due to dynamic loads; the increased magnitude of the movement due to an undersized interbody implant only exacerbates the condition, leading to more implant failures.”) To this end, Casey presents a method for patient-specific implant system including predictions of implant performance ([Abstract] “A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.” [Par 32] “Patient-specific interbody implants can be designed for optimal fit in the negative space created by removal of the disc and adjustment of the relative position of vertebrae. Surgical planning software can be used to adjust the relative positions of vertebrae and define the negative space between the vertebrae. Modifying the spatial relationship between adjacent vertebrae within a virtual design space can provide a definition of the 3D negative space into which an interbody can be delivered. Software can further be used to compare the original pathology to the corrected positions of the vertebrae. The optimal size and shape of patient-specific implants can prevent or reduce instances of dynamic failure of posterior implants.” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”) Overall, one of ordinary skill in the art would have recognized that combining the patient-specific implant system of Casey with Giraldez, Poltaretskyi, Star-lack would result in a system that allows for optimal selection of implants during the surgical procedure including predictions of implant life, ultimately resulting in more reliable, long-lasting surgical outcomes.
Claim 27. Giraldez makes obvious A method for surgical preparation and surgery, the method comprising: obtaining medical imaging data corresponding to a user; ([Par 101] “ In some embodiments, the diagnostic AI 307 may ingest patient raw data 301 and patient images 302 to generate a prediction about the appropriate timing for future procedures.”) constructing a digital model from the obtained medical imaging data, the digital model comprises a two-dimensional image representation or a three-dimensional image representation; ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) [Examiner’s note: the “three-dimensional image representation” is interpreted as a three-dimensional representation of the image, i.e. a 3D model generated from said imagery] selecting a sequence of surgical acts from a database; (Par 124] “ … computer system receives procedure information for a surgical or non-surgical procedure selected from the procedures database 1002, patient identifying information, patient measurements selected from a measurements database 1001...” [Par 33] “The location and effect of any incisions, injections, substance removal, application of a product, suturing, or any other physical manipulation made by the doctor during the procedure will be visualized on a representation of the patient's actual body. These models and simulation allow the patient and physician to visualize the effect each step of the procedure will have on the patient's body in advance of the performing the procedure”) generating a plurality of scenes by applying the sequence of surgical acts to the digital model; ([Par 32] “ For example, the computer system provides a procedure simulation by comparing a pre-operative 3D model generated before the procedure to one or more 3D post-operative models. … One or more post-operative models are then generated by the computer system based on a set of input parameters such as patient demographics, type of procedure, desired simulation time intervals, physician performing the procedure, and the products and/or product brands used in the procedure. … The post-operative models depict changes to the patient's body that occur as a result of the procedure. In one example, the changes are shown through a series of post-operative models depicting one or more intermediate steps ... the post-operative models may depict changes to the patient's body that occur as a result of actions by the physician during the procedure.”) simulating a virtual performance of the sequence of surgical acts on the digital model of the user using the generated scenes; ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.” [Par 67] “Another example includes a transformational simulation depicting every step of a surgical or non-surgical procedure.”) ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.” [Par 66] “The imaging engine 104 generates 3D models, simulations, and AR environments that provide realistic representations of surgical and non-surgical procedures as well as post-operative results and complications associated with such procedures.”) communicating through the network and ([Par 111] “Procedure simulations may be saved for record keeping purposes or shared by the patient to one or more social networks.”) ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.”) the generated plurality of scenes, and the simulated virtual performance; ({the reconstructed digital model) extracting data of interest from the reconstructed digital model; ([Par 118] “ Regarding hair replacement, this e-learning platform and consent and follow-up application includes the option to generate a 3D model of the patient's head using a number of photos or a 3D scanning device, then provide with the required simulation and planning tools to perform hair transplantation. The system auto-detects the areas from the 3D model with hair and without.”) determining the at least one pathology ([Par 49] “The patient follow-up and consent aspect of the software application further includes one or more machine learning models or artificial intelligence systems for diagnosing procedure complications from 2D images and/or 3D body scans provided of a patient's post-operative body. The diagnosis may be based on automated image classification results informed by real world diagnostic methodology from surgeons.”) based on the extracted data of interest; and ([Par 118] “ Regarding hair replacement, this e-learning platform and consent and follow-up application includes the option to generate a 3D model of the patient's head using a number of photos or a 3D scanning device, then provide with the required simulation and planning tools to perform hair transplantation. The system auto-detects the areas from the 3D model with hair and without.”) [Examiner’s note: determining the pathology “based on the extracted data of interest” is just choosing to determine the pathology in the area of interest. In this case it would be determining such diagnoses and possible complications for a hair transplant]) showing the plurality of scenes ([Par 32] “The post-operative models depict changes to the patient's body that occur as a result of the procedure. In one example, the changes are shown through a series of post-operative models depicting one or more intermediate steps ... the post-operative models may depict changes to the patient's body that occur as a result of actions by the physician during the procedure.”) [Par 35] “ ... In this example, users can change the position of the 3D model or simulation by moving his or her physical body. The system automatically detects the body part to be augmented, projects a virtual image of the body part with the effects of the procedure onto the actual body part, tracks the actual body part in real time, and changes the angle and perspective of the projected virtual image of the changed body part according to real time changes in the position of the actual body part.”)
Giraldez fails to make obvious performing, at a processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure; displaying a model; projecting information to guide surgical preparation and surgery associated with the user by projecting a holographic projection, and the holographic projection is holographic
Poltaretskyi makes obvious displaying a model ([Par 986] “As discussed above, visualization device 213 may display at least a portion of the virtual model”) projecting information to guide surgical preparation and surgery associated with the user by projecting a holographic projection, and the holographic projection is holographic ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,” [Par 165] “…MR device that includes see-through holographic lenses, sometimes referred to as waveguides, that permit a user to view real-world objects through the lens and concurrently view projected 3D holographic objects.” [Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”)
Poltaretskyi is analogous art because it is within the field of augmented reality and simulation as applied to surgical procedures. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination to create a system with enhanced collaborative features. As stated by Poltaretskyi, ([Par 2] “Many times, a surgical joint repair procedure, such as joint arthroplasty as an example, involves replacing the damaged joint with a prosthetic that is implanted into the patient's bone. Proper selection of a prosthetic that is appropriately sized and shaped and proper positioning of that prosthetic to ensure an optimal surgical outcome can be challenging.”) Surgery is an extremely delicate art in which the life of a patient is routinely on the line. This difficulty is further exasperated when further designing and implanting prosthetic devices Frequently, the acting surgeon may not be the best person suited to designing a specific prosthetic, or that surgeon may not have specialized knowledge of the specific patient or procedure they are performing. To alleviate these issue, Poltaretskyi presents a mixed reality powered collaborative system that allows a surgeon to consult with colleagues and get expert options from anywhere in the world on various aspects of the current operation that the surgeon may need assistance with. ([Par 726] “The remote physician using VR can watch the process in real time, provide feedback, and decide whether the process or step has been performed properly by the local surgeon.”) One of ordinary skill in the art would have recognized that combining the features of Poltaretskyi with those of Giraldez would produce a system that allows for sophisticated collaboration between surgeons and other medical professionals, ensuring a patient always gets the best care possible.
The combination of Giraldez and Poltaretskyi fails to make obvious performing, at a processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; generating, at the processor, several voxels representing the different types of elements of interest or different types of tissues depending on the intensity level of each voxel, the voxels representing different surfaces of individual anatomical elements; extracting, at the processor, the individual anatomical elements to form a selection of voxels; and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure;
Star-lack makes obvious ([Par 22] “In some embodiments, the dose-estimation system 130 may further discretize/partition the CT volume 210 into a set of 3D cells (or “voxels”).” [Par 25] “In some embodiments, the auto-segmentation module 220 may perform the feature-based segmentation operation based on the image density Hounsfield Unit (HU) values presented in the CT volume 210. Specifically, the auto-segmentation module 220 may evaluate the HU gradient of the voxels in CT volume 210. Using previously-defined HU value thresholds and density ranges, the auto-segmentation module 220 may identify structures in the CT volume 210 that have distinctive features. Each identified structure may then be classified, based on its respective HU values, to either non-organ materials (such as air, water), or organ regions (such as lung, adipose, soft-tissue, muscle or bone).”) extracting, at the processor, the individual anatomical elements to form a selection of voxels; ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) and performing, at the processor, at least one of the following based on the identified individual anatomical elements: clipping voxels of an image from the selection of voxels using input from a tracing tool; selecting contiguous voxels from the selection of voxels, propagating or expanding the selection of voxels; identifying concave shapes from the selection of voxels to delimit the articular surfaces; shape recognizing or co-locating anatomical parts by statistics in order to predict whether a voxel of the selection of voxels belongs to an organic tissue; and processing and refining, at the processor the selection of voxels with smoothing or correction operations of a three-dimensional structure; ([Par 31] “The auto-segmentation module 220 may use an optical flow equation to iteratively calculate the demons force as voxel displacement vectors. The voxel displacement vectors may then be regularized with the Gaussian function, and used to propagate the best-matching expert case's organ boundaries onto the current case, thereby refining the organ boundaries for the current case.” [Par 23] “After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) [Examiner’s note: this limitation is written in the alternate form; therefore, unmapped elements are not given patentable weight]
Star-lack is analogous art because it is within the field of medical image processing. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez and Poltaretskyi before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to automatically identify and separate organs in medical imagery. Although medical imaging is frequently performed with a target organ in mind, isolating that organ in the imagery can be a complex task, as typical medical imaging techniques commonly capture entire regions, such as the chest, legs, head, etc. as a consequence of their principles of operation. For example, it would be exceedingly difficult to capture an X-ray image of the bladder without the intestines, the lungs without the heart, etc. Distinguishing these organs from each other usually requires the expertise of a trained professional. This complexity if further compounded when evaluating three-dimensional imagery, such as that produced by successive computer tomography (CT) scans. One of ordinary skill in the art would have recognized the usefulness of a system capable of performing this identification automatically, allowing individual organs to be investigated separate of their surroundings. To this end, Star-lack presents a system capable of automatically segmenting three-dimensional medical imagery into separate subsets of 3D imagery that represent a single, isolated organ ([Par 23] “In some embodiments, the auto-segmentation module 220 may be configured to automatically segment the CT volume 210 into a segmented volume 225 having one or more organ regions. Each “organ region” may have delineated boundaries in the segmented volume 225, representing an area in the CT volume 210 that is associated with a patient's organ or body structure. The segmented organ regions may correspond to a patient's anatomical parts such as breasts, lungs, heart, stomach, liver, pancreas, spleen, kidneys, colon, small intestine, bladder, gonads, uterus/cervix (female), prostate (male), skeletal bone, bone marrow, and skin, etc. After auto-segmentation, each of the segmented organ regions may be associated with a subset of the voxels in the CT volume 210.”) Overall, one of ordinary skill in the art would have recognized that this combination of Star-lack with Giraldez and Poltaretskyi would produce a system capable of automatically processing and separating raw medical imagery into detailed models of individual organs, allowing the simulation of the procedure’s effects on those individual organs to be investigated in more detail.
The combination of Giraldez, Poltaretskyi, and Star-lack does not explicitly teach performing, at a processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data;
Casey makes obvious performing, at a processor, a finite-element analysis of at least one of a model or a planned implant to simulate mechanical stresses and deformations induced by physical activity of the user, in order to use the physical integrity of the anatomical part of interest as input data; ([Par 75-76] “The surgical assistance system 364 can perform a finite element analysis on a generated three-dimensional model (e.g., models of the spine, vertebrae, implants, etc.) to assess stresses, strains, deformation characteristics (e.g., load deformation characteristics), fracture characteristics (e.g., fracture toughness), fatigue life, etc. The surgical assistance system 364 can generate a three-dimensional mesh to analyze the model of the implant. Based on these results, the configuration of the implant can be varied based on one or more design criteria (e.g., maximum allowable stresses, fatigue life, etc.). Multiple models can be produced and analyzed to compare different types of implants, which can aid in the selection of a particular implant configuration… The surgical assistance system 364 can incorporate results from the analysis procedure in suggestions” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”)
Casey is analogous art because it is within the field of medical procedure planning. It would have been obvious to one of ordinary skill in the art to combine it with Giraldez, Poltaretskyi, Star-lack before the effective filing date. One of ordinary skill in the art would have been motivated to make this combination in order to better conform procedure design to each patient. As noted by Casey, many surgical procedures require implants, but these are usually in the form of generic, stock implants that may not optimally support the unique biology and injury/disease characteristics of every patient([Par 5] “he goal of interbody fusion is to grow bone between vertebra in order to seize the spatial relationships in a position that provides enough room for neural elements, including exiting nerve roots. An interbody implant device (or interbody implant, interbody cage, or fusion cage, or spine cage) is a prosthesis used in spinal fusion procedures to maintain relative position of vertebra and establish appropriate foraminal height and decompression of exiting nerves. Each patient may have individual or unique disease characteristics, but most implant solutions include implants (e.g. interbody implants) having standard sizes or shapes (stock implants).”[Par 26- 31] “Insufficient contact and load transfer between the vertebrae (anatomy) and the interbody implant (device) can produce inadequate fixation… If enough motion occurs, expulsion of the interbody implant or subsidence of the interbody implant into the adjacent vertebrae can result… Traditional implants are selected intraoperatively from a surgical kit containing likely sizes and shapes depending on the surgical approach and patient anatomy. Selection of implant size is performed by the surgeon during the surgery while the patient's spine is exposed. Often, minimal consideration is paid to implant size prior to the surgery… Even with the attention paid to the sagittal height, the implants available in surgery only come in stock sizes that are unlikely to provide optimal solutions for the particular patient or particular interbody space. Additionally, traditional stock implants do not provide any options for variable coronal angles. By selecting stock implants intraoperatively from a fixed assortment of implant sizes, the surgeon is unable to provide to the patient an optimal solution for correction of the particular spinal deformity or pathological malalignment causing patient pain… Furthermore, intraoperative selection of stock implants requires shipment and delivery of sufficient implants to cover the wide variety of patients and their unique interbody spaces. The shipping, sterilization, processing, and delivery of enough implants to surgery can be characterized as logistically burdensome and expensive. It is not uncommon for more than fifty implants to be delivered to a surgery that requires only one implant…. Improper or sub-optimal sizing of interbody implants can result in implant failures. If the interbody space is not sufficiently filled, posterior implants (including rods and plates) are required to carry more dynamic loads prior to fusion. The typical failure mode of spinal rods include fracture due to dynamic loads; the increased magnitude of the movement due to an undersized interbody implant only exacerbates the condition, leading to more implant failures.”) To this end, Casey presents a method for patient-specific implant system including predictions of implant performance ([Abstract] “A system and computer-implemented method for manufacturing an orthopedic implant involves segmenting features in an image of anatomy. Anatomic elements can be isolated. Spatial relationships between the isolated anatomic elements can be manipulated. Negative space between anatomic elements is mapped before and/or after manipulating the spatial relationships. At least a portion of the negative space can be filled with a virtual implant. The virtual implant can be used to design and manufacture a physical implant.” [Par 32] “Patient-specific interbody implants can be designed for optimal fit in the negative space created by removal of the disc and adjustment of the relative position of vertebrae. Surgical planning software can be used to adjust the relative positions of vertebrae and define the negative space between the vertebrae. Modifying the spatial relationship between adjacent vertebrae within a virtual design space can provide a definition of the 3D negative space into which an interbody can be delivered. Software can further be used to compare the original pathology to the corrected positions of the vertebrae. The optimal size and shape of patient-specific implants can prevent or reduce instances of dynamic failure of posterior implants.” [Par 85] “At block 540, once positioned, the corrected anatomical model and/or virtual implant can be evaluated to assess expected treatment outcomes, performance of the virtual implant (e.g., fatigue life, loading characteristics, etc.), or the like. For example, contact and load transfer can be analyzed. The corrected model can be adjusted to properly position anatomic elements with respect to the virtual implant/medical device.”) Overall, one of ordinary skill in the art would have recognized that combining the patient-specific implant system of Casey with Giraldez, Poltaretskyi, Star-lack would result in a system that allows for optimal selection of implants during the surgical procedure including predictions of implant life, ultimately resulting in more reliable, long-lasting surgical outcomes.
Claim 4. Giraldez makes obvious wherein([Par 35] “ The system automatically detects the body part to be augmented, projects a virtual image of the body part with the effects of the procedure onto the actual body part, tracks the actual body part in real time, and changes the angle and perspective of the projected virtual image of the changed body part according to real time changes in the position of the actual body part.” {wherein the projection can be positioned on the user)
Poltaretskyi makes obvious the holographic projection ([Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”)
Claim 5. Giraldez makes obvious wherein the generated plurality of three- dimensional scenes ([Par 32] “ For example, the computer system provides a procedure simulation by comparing a pre-operative 3D model generated before the procedure to one or more 3D post-operative models. … One or more post-operative models are then generated by the computer system based on a set of input parameters such as patient demographics, type of procedure, desired simulation time intervals, physician performing the procedure, and the products and/or product brands used in the procedure. … The post-operative models depict changes to the patient's body that occur as a result of the procedure. In one example, the changes are shown through a series of post-operative models depicting one or more intermediate steps ... the post-operative models may depict changes to the patient's body that occur as a result of actions by the physician during the procedure.”) or the simulated virtual performance is ({wherein the generated plurality of three-dimensional scenes)
Poltaretskyi makes obvious displayed in a collaborative mode to ([Par 733] “ As mentioned elsewhere in this disclosure, an MR system can include multiple visualization devices so that multiple users can simultaneously see the same images and share the same 3D scene, such as MR intraoperative guidance content 1802 (FIG. 18)”) remotely assist the operator ([Par 732] “in another yet example, an MR system that includes both MR and remote users (such as VR users or users that have display screens that display the MR views of others) may be used to facilitate emergency care. In this case, a remote user may be leveraged to assist an MR user with emergency care via an MR system.) to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode. ([Par 754] “ In still other examples, MR systems may allow for educational training during a medical procedure or surgery. That is to say, one or more passive viewers to the procedure may have passive MR visualization devices that provide the user with a view of the MR environment without any control over the MR environment. Such passive viewers may be located in the operating room, or in a viewing room adjacent the operating room, or remotely from the operating room.” {to train the operator in an observational mode)
Claim 6. Giraldez makes obvious implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model ([Par 122 “ Artificial intelligence models or machine learning algorithms provided by the artificial intelligence libraries 1003 interface with the 3D modelling engine 1010 to generate 3D models, with the simulation engine 1015 to generate simulations...” {implementing artificial intelligence to model)) the simulated virtual performance. ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.”)
Claim 7. Giraldez makes obvious generating second digital models ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body”)of at least one of: anatomical elements, ([Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,” {generating device digital models of anatomical elements) implantable medical devices, and ancillary instrumentation corresponding to the sequence of surgical acts, wherein the second digital models ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body”) include three-dimensional objects ([Par 26] “…generating, by a 3D modelling engine, a 3D model of the body part…”) based on the reconstructed digital model ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.”)or data of interest extracted from the reconstructed digital model ({based on the reconstructed digital model)
Claim 8. Giraldez makes obvious wherein the anatomical elements, ([Par 26] “generating, by a 3D modelling engine, a 3D model of the body part”) the implantable medical devices, or the ancillary instrumentation are based on anatomy of the user. [Par 47] “To provide more realistic representations, post-operative complication simulations presented to patients after a procedure may be generated from 2D images or 3D body scans of the patient's body after the procedure.” {wherein the anatomical elements are based on the anatomy of the user)
Claim 9. Giraldez makes obvious ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body” [Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,”)
Poltaretskyi makes obvious projecting to guide an operator, ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,” [Par 165] “…MR device that includes see-through holographic lenses, sometimes referred to as waveguides, that permit a user to view real-world objects through the lens and concurrently view projected 3D holographic objects.” ) wherein the projecting includes holographic projection. ([Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”)
Claim 10. Giraldez makes obvious ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body” [Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,”) implantable medical devices, and ancillary instrumentation ({generating device digital models of anatomical elements)
Poltaretskyi makes obvious in response to a structured surgical planning of the user ending. ([Par 189] “During the preoperative phase, a surgical plan is developed. The preoperative phase is followed by a manufacturing and delivery phase… An intraoperative phase follows the manufacturing and delivery phase... The intraoperative phase is followed by the postoperative phase (308) The postoperative phase includes activities occurring after the surgical plan is complete.”)
Claim 11. Giraldez makes obvious ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body” [Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,”)
Poltaretskyi makes obvious generating a digital file ([Par 192] “the medical professional or other user establishes an electronic case file for the patient. The electronic case file for the patient may include information related to the patient…” [Par 232] “…information and images corresponding to the selected surgical plan, including an image 1006 of a surgical plan file (e.g., a pdf file or other appropriate media format) that corresponds to the selected plan…”), and transmitting the generated digital file to a manufacturing facility to create a three-dimensional model using the generated digital file. ([Par 199] “ Additionally, in the example of FIG. 4, a step of selecting and manufacturing surgical items is performed (416). During the step of selecting and manufacturing surgical items, manufacturing and delivery system 106 (FIG. 1) may manufacture surgical items for use during the surgery described by the surgical plan. For example, the surgical items may include surgical implants, surgical tools, and other items required to perform the surgery described by the surgical plan.”)
Claim 16. Giraldez makes obvious implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model ([Par 122 “ Artificial intelligence models or machine learning algorithms provided by the artificial intelligence libraries 1003 interface with the 3D modelling engine 1010 to generate 3D models, with the simulation engine 1015 to generate simulations...” {implementing artificial intelligence to model) the simulated virtual performance. ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body”)
Claim 17. Giraldez makes obvious generating second digital models ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body”) of at least one of: anatomical elements, ([Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,” {generating device digital models of anatomical elements) implantable medical devices, and ancillary instrumentation corresponding to the sequence of surgical acts, wherein the second digital models ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body”) include three-dimensional objects ([Par 26] “…generating, by a 3D modelling engine, a 3D model of the body part…”) based on the reconstructed digital model ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.”)or the extracted data of interest. ({based on the reconstructed digital model)
Claim 18. Giraldez makes obvious wherein the anatomical elements, ([Par 26] “generating, by a 3D modelling engine, a 3D model of the body part”) the implantable medical devices, or the ancillary instrumentation are based on anatomy of the user. [Par 47] “To provide more realistic representations, post-operative complication simulations presented to patients after a procedure may be generated from 2D images or 3D body scans of the patient's body after the procedure.” {wherein the anatomical elements are based on the anatomy of the user)
Claim 19. Giraldez makes obvious ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body” [Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,”)
Poltaretskyi makes obvious projecting to guide an operator, ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,” [Par 165] “…MR device that includes see-through holographic lenses, sometimes referred to as waveguides, that permit a user to view real-world objects through the lens and concurrently view projected 3D holographic objects.”) wherein the projecting includes holographic projection. ([Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”)
Claim 22. Giraldez makes obvious the generated images or the simulated virtual performance ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body. { the simulated virtual performance))
Poltaretskyi makes obvious displayed in a collaborative mode to ([Par 733] “ As mentioned elsewhere in this disclosure, an MR system can include multiple visualization devices so that multiple users can simultaneously see the same images and share the same 3D scene, such as MR intraoperative guidance content 1802 (FIG. 18)”) remotely assist the operator ([Par 732] “in another yet example, an MR system that includes both MR and remote users (such as VR users or users that have display screens that display the MR views of others) may be used to facilitate emergency care. In this case, a remote user may be leveraged to assist an MR user with emergency care via an MR system.) to perform a corresponding procedure requiring multiple assessments or to train the operator in an observational mode. ([Par 754] “ In still other examples, MR systems may allow for educational training during a medical procedure or surgery. That is to say, one or more passive viewers to the procedure may have passive MR visualization devices that provide the user with a view of the MR environment without any control over the MR environment. Such passive viewers may be located in the operating room, or in a viewing room adjacent the operating room, or remotely from the operating room.” {to train the operator in an observational mode)
Claim 23. Giraldez makes obvious instructions implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model ([Par 122 “ Artificial intelligence models or machine learning algorithms provided by the artificial intelligence libraries 1003 interface with the 3D modelling engine 1010 to generate 3D models, with the simulation engine 1015 to generate simulations...” {implementing artificial intelligence to model) the simulated virtual performance ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.” )
Claim 24. Giraldez makes obvious Giraldez makes obvious instructions generating second digital models ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body”) of at least one of: anatomical elements, ([Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,” {generating device digital models of anatomical elements) implantable medical devices, and ancillary instrumentation corresponding to the sequence of surgical acts, wherein the second digital models ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body”) include three-dimensional objects ([Par 26] “…generating, by a 3D modelling engine, a 3D model of the body part…”) based on the reconstructed digital model ([Par 34] “ In one example the AR system of the present invention generates 3D models of patient bodies from 2D images and/or 3D body scans.”) or the extracted data of interest. ({based on the reconstructed digital model)
Claim 25. Giraldez makes obvious wherein the anatomical elements, ([Par 26] “generating, by a 3D modelling engine, a 3D model of the body part”) the implantable medical devices, or the ancillary instrumentation are based on anatomy of the user. [Par 47] “To provide more realistic representations, post-operative complication simulations presented to patients after a procedure may be generated from 2D images or 3D body scans of the patient's body after the procedure.” {wherein the anatomical elements are based on the anatomy of the user)
Claim 26. Giraldez makes obvious instructions ([Par 19] “using a second predictive model, generating a second modified 3D model of the at least part of the patient's body” [Par 26] “ receiving a selection of a medical procedure affecting a body part of a patient, patient measurements, and an image of the body part of the patient; generating, by a 3D modelling engine, a 3D model of the body part comprising a three-dimensional mesh structure covered in a texture material, the patient mesh structure dimensioned according to patient measurements,”)
Poltaretskyi makes obvious projecting to guide an operator, ([Par 200] “In the example of FIG. 4, a surgical procedure may be performed with guidance from intraoperative system 108 (FIG. 1) (418). For example, a surgeon may perform the surgery while wearing a head-mounted MR visualization device of intraoperative system 108 that presents guidance information to the surgeon. The guidance information may help guide the surgeon through the surgery,” [Par 165] “…MR device that includes see-through holographic lenses, sometimes referred to as waveguides, that permit a user to view real-world objects through the lens and concurrently view projected 3D holographic objects.”) wherein the projecting includes holographic projection. ([Par 174] “ A holographic projector, in some examples, may project a hologram for general viewing by multiple users or a single user without a headset, rather than viewing only by a user wearing a headset.”)
Claim 30. Giraldez makes obvious implementing artificial intelligence and/or a simulation of physical systems by numerical mathematic modeling to model([Par 122 “ Artificial intelligence models or machine learning algorithms provided by the artificial intelligence libraries 1003 interface with the 3D modelling engine 1010 to generate 3D models, with the simulation engine 1015 to generate simulations...” {implementing artificial intelligence to model the simulated virtual performance) the simulated virtual performance. ([Par 32] “In one embodiment, the platform includes a computer system that provides patient models and procedure simulations that display the effect of each step of a procedure on the patient's own body.”)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael P Mirabito whose telephone number is (703)756-1494. The examiner can normally be reached M-F 10:30 am - 6:30 pm.
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/M.P.M./ Examiner, Art Unit 2187
/EMERSON C PUENTE/ Supervisory Patent Examiner, Art Unit 2187