DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 19, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1, line 14, “a determined surgical modification” should read “the surgical modification” to correspond to the previous limitation.
Appropriate correction is required.
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.
Claim 8 is 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.
Relative Terminology:
The term “detailed” in claim 8 is a relative term which renders the claim indefinite. The term “detailed” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. In applicant’s PGPublication, paragraph 0075 states, “The first image may comprise detailed soft tissue information (e.g., the first image may be obtained from an MRI scan) and the second image may comprise detailed bony tissue information (e.g., the second image may be obtained from a CT scan).” However, this appears as exemplary, and not a definitive bound for that “detailed” represents. Said differently, an MRI scan appears to be a type of “detailed soft tissue information” however, not the only type. For the same of examination, the term “detailed soft tissue information” will be read as “soft tissue information” and “detailed bony tissue information” will be read as “bony tissue information”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-8, 10-11, 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 11,086,970 to Jaramaz et al. (hereinafter Jaramaz), and further in view of U.S. Patent No. 10,874,464 to Roh et al. (hereinafter Roh).
Regarding independent claim 1, Jaramaz discloses A method for planning a surgical procedure (abstract, “Systems and methods for generating a surgical plan for altering an abnormal bone using a generic normal bone model are discussed. ”) comprising:
receiving information corresponding to an examination of a patient (column 5, line 16, “The abnormal bone representation can include one of more of a medical image, a point cloud, a parametric model, or other morphological description of the abnormal bone. ”) and an image of a patient anatomy (Figure 5, element 510; column 10, line 24, “A representation of an abnormal bone or a portion of the abnormal bone is received at 510.”);
processing the image of the patient anatomy to identify one or more features in the image and yield a processed image (column 7, line 62, “The feature extraction module 310 is configured to extract a plurality of model features from the registered generic model and a plurality of abnormal bone features from the abnormal bone representation. In an example, types of the extracted features can include one or more geometric parameters such as a location, an orientation, a curvature, a contour, a shape, an area, a volume, or other volumetric parameters. In another example, the extracted features can include one or more intensity-based parameters. The features can be extracted in the space domain, frequency domain, or space-frequency domain.”);
comparing a feature of a first anatomical element at the predicted location of the anatomical abnormality with a corresponding feature of a second anatomical element at a different location (column 10, line 45, “At 520, a generic normal bone model can be received. The generic normal bone model includes a data set representing a normal bone or a portion of the normal bone having an anatomical origin comparable to the abnormal bone received at 510. The generic normal bone model can represent the shape or appearance of the anatomical structure of the normal bone.” Column 12, line 10, “At 540, one or more abnormal regions of the abnormal bone can be detected. The abnormity can be detected using a comparison between the registered generic model and the abnormal bone representation.”), wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality (Column 12, line 10, “At 540, one or more abnormal regions of the abnormal bone can be detected. The abnormity can be detected using a comparison between the registered generic model and the abnormal bone representation.”);
identifying, based on the predicted location of the anatomical abnormality and the comparison, a surgical modification of the first anatomical element (abstract, “ A surgical planning module can include a registration module configured to register the generic normal bone model to the abnormal bone representation by creating a registered generic model. A surgical plan formation module can be configured to identify one or more abnormal regions of the abnormal bone using the registered generic model.” Column 5, line 62, “. In an example, the surgical plan formation module 132 can calculate a level of disconformity between the registered generic model and the abnormal bone representation. The disconformity can be used as a basis for surgical planning Examples of the surgical plan formation module 132 are discussed below, such as with reference of FIG. 3.”); and
generating, based on a determined surgical modification, machine readable instructions for at least one surgical step (column 9, line 18, “ In some examples, the alteration decision module 330 can include instructions for incrementally altering the one or more abnormal regions of the abnormal bone by gradually removing the identified excess bone tissue from the abnormal bone such as following a pre-specified procedure.”).
Jaramaz fails to explicitly disclose as further recited. However, Roh discloses inputting the information and the processed image into an analytical model configured to identify, using artificial intelligence, a predicted location of an anatomical abnormality (column 5, line 45, “A type of tissue shown in the first image can be identified based, at least in part, on a neural network model trained on an image training set. In response to determining that the identified type of tissue belongs to a set of targeted types, causing the robotic surgical apparatus to perform a first surgical action with respect to the region of interest in accordance with a surgical plan. ”)
Jaramaz is directed toward, “Systems and methods for generating a surgical plan for altering an abnormal bone using a generic normal bone model (abstract).” Roh is directed toward, “ a system and method for utilizing artificial intelligence to operate a surgical robot (e.g., to perform a laminectomy), including a surgical robot, an artificial intelligence guidance system, an image recognition system, an image recognition database, and a database of past procedures with sensor data, electronic medical records, and imaging data (abstract).” As can be easily seen by one of ordinary skill in the art before the effective filing date of the claimed invention, Jaramaz and Roh are directed toward similar methods of endeavor of surgical planning and execution. Further, one of ordinary skill in the art before the effective filing date of the claimed invention would be aware using artificial intelligence allows for an increase in efficiency and accuracy as opposed to manual annotation which are both desired when analyzing images for use in surgery determinations. Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure optimal accuracy and efficiency can be achieved in relation to analyzing the medical images for surgical processing.
Regarding dependent claim 2, the rejection of claim 1 is incorporated herein. Additionally, Jaramaz further discloses wherein the surgical modification corresponds to removing a portion of the first anatomical element (column 9, line 18, “ In some examples, the alteration decision module 330 can include instructions for incrementally altering the one or more abnormal regions of the abnormal bone by gradually removing the identified excess bone tissue from the abnormal bone”).
Regarding dependent claim 3, the rejection of claim 1 is incorporated herein. Additionally, Roh further discloses wherein the surgical modification corresponds to a decompression procedure (column 13, line 20, “A software that utilizes artificial intelligence to determine the optimal trajectory and incision placement for any type of spinal surgery (e.g., spinal fusion, decompression procedures, screw placement, cage insertion, etc.).”).
One of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware there are many different types of spinal surgeries. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure the system is widely applicable to all different types of surgery.
Regarding dependent claim 4, the rejection of claim 3 is incorporated herein. Additionally, Roh further discloses wherein the examination of the patient identifies an initial spinal level at which to perform the decompression procedure (column 4, line 55, “The system can identify anatomical features, abnormalities, tissue margins, tissue characteristics, tissue types, tissue interfaces, or combinations thereof based on, for example, preset criteria, physician input, etc. For example, the image recognition system can evaluate images to identify landmarks and generate a surgical plan based, at least in part, on those landmarks. The landmarks can be identified by the system, physician, or both. In some procedures, the landmarks can be identifiable anatomical features (e.g., spinous processes, bony protrusions, facet joints, nerves, spinal cord, intervertebral disc, vertebral endplates, etc.) along the patient's spine to generate a surgical plan.” The physician identifying a landmark as an abnormality would be the level to perform the procedure; column 12, line 26, “Improvements in “Incision localization/marking” are made such as Pre-Operative Image. A user can input information for performing procedures. The information can include, without limitation, targeted tissue, non-targeted tissue, critical tissue (e.g., tissue to be protected or avoided), access paths, cutting/drilling paths, instrument orientations (e.g., delivery instruments, surgical instruments, etc.), working spaces, safety barriers, hold spots, or the like.”).
One of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware when performing spinal surgeries there are different spinal levels and each may have different treatment options; said differently, the cervical spine may be treated different than the lumbar spine. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure the system is aware of the details of the spine, to determine an optimal surgery.
Regarding dependent claim 5, the rejection of claim 1 is incorporated herein. Additionally, Roh further discloses further comprising:
receiving at least one medical record corresponding to the patient (abstract, “ a database of past procedures with sensor data, electronic medical records, and imaging data.”),
wherein the inputting further comprises inputting the at least one medical record into the analytical model (abstract, “ a database of past procedures with sensor data, electronic medical records, and imaging data.”).
One of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware patient medical files can contain helpful information to aid in determining next steps for surgery; said differently patient age or comorbidities can be relevant to the surgery protocol. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure the patient receives optimal treatment based on their medical history.
Regarding dependent claim 6, the rejection of claim 1 is incorporated herein. Additionally, Jaramaz further discloses wherein the image is obtained from a CT (computed tomography) scan or an MRI (magnetic resonance imaging) scan (column 10, line 32, “ In various examples, the abnormal bone representation can include at least one medical image such as an X-ray, an ultrasound image, a computed tomography (CT) scan, a magnetic resonance (MR) image, a positron emission tomography (PET) image, a single-photon emission computed tomography (SPECT) image, or an arthrogram, among other 2D or 3D images. ”).
Regarding dependent claim 7, the rejection of claim 1 is incorporated herein. Additionally, Jaramaz further discloses wherein the image is a first image and the method further comprises:
receiving a second image (column 10, line 32, “ In various examples, the abnormal bone representation can include at least one medical image such as an X-ray, an ultrasound image, a computed tomography (CT) scan, a magnetic resonance (MR) image, a positron emission tomography (PET) image, a single-photon emission computed tomography (SPECT) image, or an arthrogram, among other 2D or 3D images. ”); and
combining the first image and the second image (column 10, line 32, “ In various examples, the abnormal bone representation can include at least one medical image such as an X-ray, an ultrasound image, a computed tomography (CT) scan, a magnetic resonance (MR) image, a positron emission tomography (PET) image, a single-photon emission computed tomography (SPECT) image, or an arthrogram, among other 2D or 3D images.” Inputting more than one is read that they are combine to be input; i.e. 3D images are made of slices (multiple images), which are then input in 3D).
Regarding dependent claim 8, the rejection of claim 7 is incorporated herein. Additionally, Jaramaz further discloses wherein the first image comprises detailed soft tissue information (column 10, line 32, “ In various examples, the abnormal bone representation can include at least one medical image such as an X-ray, an ultrasound image, a computed tomography (CT)” CT is one example showing soft tissue information) and the second image comprises detailed bony tissue information (column 10, line 32, “ In various examples, the abnormal bone representation can include at least one medical image such as an X-ray” x-ray is exemplary of bone tissue information).
Regarding dependent claim 10, the rejection of claim 1 is incorporated herein. Additionally, Roh further discloses wherein the anatomical abnormality is a spinal stenosis (column 9, line 1, “perform a stenosis decompression procedure at a different level along the spine.”)
One of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware there are many different types of spinal conditions. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure the system is widely applicable to all different types of spinal conditions.
Regarding dependent claim 11, the rejection of claim 10 is incorporated herein. Additionally, Jaramaz and Roh in the combination fail to explicitly disclose further comprising: grading the spinal stenosis on a numerical scale based on the comparison. However, Jaramaz discloses at column 5, line 62, “calculate a level of disconformity between the registered generic model and the abnormal bone representation.” Though not explicit to spinal stenosis, Jaramaz is applied to bones, of which the spine is composed of. Further, levels are well known to be expressed in numerical values for understanding by a reviewer. Thus, determining the level of difference between the normal and abnormal bones, is read as a numerical level.
Regarding dependent claim 13, the rejection of claim 1 is incorporated herein. Additionally, Roh further discloses wherein identifying the predicted location of the anatomical abnormality includes an analysis of how spinal nerves are spread out in the image of the patient anatomy (column 4, line 63, “In some procedures, the landmarks can be identifiable anatomical features (e.g., spinous processes, bony protrusions, facet joints, nerves, spinal cord, intervertebral disc, vertebral endplates, etc.) along the patient's spine to generate a surgical plan.”).
One of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware there are many nerves close to the spinal column and damaging nerves can have disastrous patient outcomes. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure the system is aware of the nerve locations, to allow for optimal patient outcomes.
Regarding independent claim 14, Jaramaz discloses A method for planning a (abstract, “Systems and methods for generating a surgical plan for altering an abnormal bone using a generic normal bone model are discussed.”)comprising:
receiving, at a processor from a first database, information corresponding to a patient examination, the information comprising information other than an image (column 5, line 16, “The abnormal bone representation can include one of more of a medical image, a point cloud, a parametric model, or other morphological description of the abnormal bone. ”);
receiving, at the processor from a second database, an image of a spinal region of a patient (Figure 5, element 510; column 10, line 24, “A representation of an abnormal bone or a portion of the abnormal bone is received at 510.”);
identifying, with the processor, a location of an anatomical abnormality in the spinal region (column 7, line 62, “The feature extraction module 310 is configured to extract… a plurality of abnormal bone features from the abnormal bone representation.”);
comparing, with the processor, a feature of a first anatomical element at the location of the anatomical abnormality with a corresponding feature of a second anatomical element at a different location (column 10, line 45, “At 520, a generic normal bone model can be received. The generic normal bone model includes a data set representing a normal bone or a portion of the normal bone having an anatomical origin comparable to the abnormal bone received at 510. The generic normal bone model can represent the shape or appearance of the anatomical structure of the normal bone.” Column 12, line 10, “At 540, one or more abnormal regions of the abnormal bone can be detected. The abnormity can be detected using a comparison between the registered generic model and the abnormal bone representation.”), wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality (Column 12, line 10, “At 540, one or more abnormal regions of the abnormal bone can be detected. The abnormity can be detected using a comparison between the registered generic model and the abnormal bone representation.”);
identifying, with the processor and based on the location of the anatomical abnormality and the comparison, a surgical modification of the first anatomical element (abstract, “ A surgical planning module can include a registration module configured to register the generic normal bone model to the abnormal bone representation by creating a registered generic model. A surgical plan formation module can be configured to identify one or more abnormal regions of the abnormal bone using the registered generic model.” Column 5, line 62, “. In an example, the surgical plan formation module 132 can calculate a level of disconformity between the registered generic model and the abnormal bone representation. The disconformity can be used as a basis for surgical planning Examples of the surgical plan formation module 132 are discussed below, such as with reference of FIG. 3.”); and
generating, with the processor and based on the surgical modification, machine readable instructions for at least one surgical step (column 9, line 18, “ In some examples, the alteration decision module 330 can include instructions for incrementally altering the one or more abnormal regions of the abnormal bone by gradually removing the identified excess bone tissue from the abnormal bone such as following a pre-specified procedure.”).
Jaramaz fails to explicitly disclose as further recited. However, Roh discloses A method for planning a decompression procedure (abstract, “This invention is a system and method for utilizing artificial intelligence to operate a surgical robot (e.g., to perform a laminectomy);” column 13, line 20, “A software that utilizes artificial intelligence to determine the optimal trajectory and incision placement for any type of spinal surgery (e.g., spinal fusion, decompression procedures, screw placement, cage insertion, etc.)”) comprising:
identifying, with the processor and using artificial intelligence, the location of the anatomical abnormality based on the information and the comparison (column 5, line 45, “A type of tissue shown in the first image can be identified based, at least in part, on a neural network model trained on an image training set. In response to determining that the identified type of tissue belongs to a set of targeted types, causing the robotic surgical apparatus to perform a first surgical action with respect to the region of interest in accordance with a surgical plan. ”)
Jaramaz is directed toward, “Systems and methods for generating a surgical plan for altering an abnormal bone using a generic normal bone model (abstract).” Roh is directed toward, “ a system and method for utilizing artificial intelligence to operate a surgical robot (e.g., to perform a laminectomy), including a surgical robot, an artificial intelligence guidance system, an image recognition system, an image recognition database, and a database of past procedures with sensor data, electronic medical records, and imaging data (abstract).” As can be easily seen by one of ordinary skill in the art before the effective filing date of the claimed invention, Jaramaz and Roh are directed toward similar methods of endeavor of surgical planning and execution. Further, one of ordinary skill in the art before the effective filing date of the claimed invention would be aware using artificial intelligence allows for an increase in efficiency and accuracy as opposed to manual annotation which are both desired when analyzing images for use in surgery determinations. Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure optimal accuracy and efficiency can be achieved in relation to analyzing the medical images for surgical processing.
Regarding dependent claim 15, the rejection of claim 14 is incorporated herein. Additionally, Jaramaz in the combination further discloses further comprising:
labeling, with the processor and in a model of the spinal region of the patient, a portion of at least one vertebra to remove during the decompression procedure (column 2, line 47, “A surgical plan formation module can be configured to identify one or more abnormal regions of the abnormal bone using the registered generic model.” Column 9, line 17, “ In some examples, the alteration decision module 330 can include instructions for incrementally altering the one or more abnormal regions of the abnormal bone by gradually removing the identified excess bone tissue from the abnormal bone”).
Regarding dependent claim 16, the rejection of claim 14 is incorporated herein. Additionally, Roh in the combination further discloses further comprising:
determining a spinal level at which to perform the decompression procedure (column 13, line 20, “A software that utilizes artificial intelligence to determine the optimal trajectory and incision placement for any type of spinal surgery (e.g., spinal fusion, decompression procedures, screw placement, cage insertion, etc.).”).
One of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware when performing spinal surgeries there are different spinal levels and each may have different treatment options; said differently, the cervical spine may be treated different than the lumbar spine. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure the system is aware of the details of the spine, to determine an optimal surgery.
Regarding dependent claim 17, the rejection of claim 14 is incorporated herein. Additionally, Roh in the combination further discloses wherein the anatomical abnormality comprises spinal stenosis (column 9, line 1, “perform a stenosis decompression procedure at a different level along the spine”).
Jaramaz and Roh in the combination fail to explicitly disclose further comprising determining whether the spinal stenosis is a lateral stenosis or a central stenosis. However, one of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware determining an accurate and specific diagnosis can inform a more accurate and successful treatment plan. Said differently, treating central spinal stenosis versus lateral stenosis could involve different protocols, and thus detecting them would inform the protocol selected. Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the teaching of Jaramaz and Roh in order to ensure the diagnosis is as accurate as possible to select the optimal treatment protocol corresponding to the diagnosis.
Regarding dependent claim 18, the rejection of claim 14 is incorporated herein. Additionally, Roh in the combination further discloses further comprising:
segmenting, with the processor, the spinal region as depicted in the image to define boundaries of individual elements of the spinal region (column 4, line 59“the image recognition system can evaluate images to identify landmarks and generate a surgical plan based, at least in part, on those landmarks. The landmarks can be identified by the system, physician, or both. In some procedures, the landmarks can be identifiable anatomical features (e.g., spinous processes, bony protrusions, facet joints, nerves, spinal cord, intervertebral disc, vertebral endplates, etc.) along the patient's spine to generate a surgical plan.”); and
identifying, with the processor, one or more spinal nerves in the image (column 11, line 67, “ Other important areas can be identified (such as nerves)”).
One of ordinary skill in the art before the effective filing date of the claimed invention would be easily aware there are many nerves close to the spinal column and damaging nerves can have disastrous patient outcomes. Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure the system is aware of the nerve locations, to allow for optimal patient outcomes.
Regarding dependent claim 19, the rejection of claim 14 is incorporated herein. Additionally, Jaramaz in the combination further discloses wherein the at least one surgical step corresponds to removing an identified portion of at least one vertebra (column 2, line 30, “determining the shape and volume of the bone to be removed, and generating a surgical plan accordingly, which can be used within a robotic surgical cutting instrument to perform the planned procedure.”).
Regarding independent claim 20, Jaramaz discloses A system for performing a (abstract, “Systems and methods for generating a surgical plan for altering an abnormal bone using a generic normal bone model are discussed. ”) comprising:
an interface (column 2, line 41, “an input interface”);
at least one processor (column 16, line 3, “The example computer system 700 includes a processor 702 (such as a central processing unit (CPU), a graphics processing unit (GPU), or both), a main memory 704 and a static memory 706, which communicate with each other via a bus 708. ”); and
a memory storing instructions for execution by the at least one processor that, when executed (column 15, line 50, “FIG. 7 is a block diagram that illustrates an example of a machine in the form of a computer system 700 within which instructions, for causing the computer system to perform any one or more of the methods discussed herein, may be executed.” Column 16, line 18, “The instructions 724 may also reside, completely or at least partially, within the main memory 704, static memory 706, and/or within the processor 702 during execution thereof by the computer system 700, the main memory 704 and the processor 702 also constituting machine-readable media. ”), cause the at least one processor to:
receive, via the interface, information corresponding to a patient examination, the information comprising information other than an image (column 5, line 16, “The abnormal bone representation can include one of more of a medical image, a point cloud, a parametric model, or other morphological description of the abnormal bone. ”);
receive a three-dimensional image of at least a portion of an anatomy of a patient (Figure 5, element 510; column 10, line 24, “A representation of an abnormal bone or a portion of the abnormal bone is received at 510.”);
compare a feature of a first anatomical element at the predicted location of the anatomical abnormality with a corresponding feature of a second anatomical element at a different location (column 10, line 45, “At 520, a generic normal bone model can be received. The generic normal bone model includes a data set representing a normal bone or a portion of the normal bone having an anatomical origin comparable to the abnormal bone received at 510. The generic normal bone model can represent the shape or appearance of the anatomical structure of the normal bone.” Column 12, line 10, “At 540, one or more abnormal regions of the abnormal bone can be detected. The abnormity can be detected using a comparison between the registered generic model and the abnormal bone representation.”), wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality (Column 12, line 10, “At 540, one or more abnormal regions of the abnormal bone can be detected. The abnormity can be detected using a comparison between the registered generic model and the abnormal bone representation.”);
identify, based on the comparison, a surgical modification of the first anatomical element (abstract, “ A surgical planning module can include a registration module configured to register the generic normal bone model to the abnormal bone representation by creating a registered generic model. A surgical plan formation module can be configured to identify one or more abnormal regions of the abnormal bone using the registered generic model.” Column 5, line 62, “. In an example, the surgical plan formation module 132 can calculate a level of disconformity between the registered generic model and the abnormal bone representation. The disconformity can be used as a basis for surgical planning Examples of the surgical plan formation module 132 are discussed below, such as with reference of FIG. 3.”); and
generate machine-readable instructions for at least one surgical step of the surgical modification (column 9, line 18, “ In some examples, the alteration decision module 330 can include instructions for incrementally altering the one or more abnormal regions of the abnormal bone by gradually removing the identified excess bone tissue from the abnormal bone such as following a pre-specified procedure.”).
Jaramaz fails to explicitly disclose as further recited. However, Roh discloses A system for performing a decompression procedure (abstract, “This invention is a system and method for utilizing artificial intelligence to operate a surgical robot (e.g., to perform a laminectomy);” column 13, line 20, “A software that utilizes artificial intelligence to determine the optimal trajectory and incision placement for any type of spinal surgery (e.g., spinal fusion, decompression procedures, screw placement, cage insertion, etc.)”) comprising:
identify, using artificial intelligence, a predicted location of an anatomical abnormality (column 5, line 45, “A type of tissue shown in the first image can be identified based, at least in part, on a neural network model trained on an image training set. In response to determining that the identified type of tissue belongs to a set of targeted types, causing the robotic surgical apparatus to perform a first surgical action with respect to the region of interest in accordance with a surgical plan. ”)
Jaramaz is directed toward, “Systems and methods for generating a surgical plan for altering an abnormal bone using a generic normal bone model (abstract).” Roh is directed toward, “ a system and method for utilizing artificial intelligence to operate a surgical robot (e.g., to perform a laminectomy), including a surgical robot, an artificial intelligence guidance system, an image recognition system, an image recognition database, and a database of past procedures with sensor data, electronic medical records, and imaging data (abstract).” As can be easily seen by one of ordinary skill in the art before the effective filing date of the claimed invention, Jaramaz and Roh are directed toward similar methods of endeavor of surgical planning and execution. Further, one of ordinary skill in the art before the effective filing date of the claimed invention would be aware using artificial intelligence allows for an increase in efficiency and accuracy as opposed to manual annotation which are both desired when analyzing images for use in surgery determinations. Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Roh in order to ensure optimal accuracy and efficiency can be achieved in relation to analyzing the medical images for surgical processing.
Claim(s) 9 is rejected under 35 U.S.C. 103 as being unpatentable over Jaramaz and Roh as applied to claim 1 above, and further in view of U.S. Patent No. 10,166,019 to Nawana et al. (hereinafter Nawana).
Regarding dependent claim 9, the rejection of claim 1 is incorporated herein. Additionally, Jaramaz and Roh in the combination fails to explicitly disclose wherein the information includes results of one or more of a soft tissue tenderness test, a range of motion test, or a straight leg raise test.
However, Nawana discloses wherein the information includes results of one or more of a soft tissue tenderness test, a range of motion test (column 8, line 31, “The information regarding the at least one of the plurality of patient-specific factors can include receiving data regarding any one or more of mobility, gait, walking speed, flexibility, muscular strength, posture, range of motion, pain, neurologic tracking, joint movement tracking, bone density, and musculo-skeletal pain levels.”), or a straight leg raise test.
As noted above, Jaramaz and Roh are directed toward similar methods of endeavor of surgical planning and execution. Nawana is directed toward methods of surgical intervention and planning (abstract). As can be easily seen by one of ordinary skill in the art, Jaramaz, Roh and Nawana are directed toward similar methods of endeavor of surgical planning and execution. Further, having more data to diagnosis and perform surgery based on allows for a more accurate diagnosis of a patient; since the medical record contains even more information such as survey results, this can aid a physician to know more information about a patient, allowing for a higher degree of accuracy of the diagnosis. Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Nawana in order to incorporate test result data from the medical record, to provide an even more accurate diagnostic result due to the increase in data inputs.
Claim(s) 12 is rejected under 35 U.S.C. 103 as being unpatentable over Jaramaz and Roh as applied to claim 11 above, and further in view of U.S. Publication No. 2020/0373013 to Cao et al. (hereinafter Cao).
Regarding dependent claim 12, the rejection of claim 11 is incorporated herein. Additionally, Jaramaz and Roh in the combination fail to explicitly disclose wherein grading the spinal stenosis includes further grading the spinal stenosis on a color intensity scale.
However, Cao discloses wherein grading the spinal stenosis includes further grading the spinal stenosis on a color intensity scale (paragraph 0127, "renders a severity of stenosis rating as a number value (e.g. 70% more stenotic as compared to a normal population) or as a mapped word value for a given range (e.g. severe stenosis) or as a visual representation (e.g. donut graph or bar graph);" clearly a comparison is performed between normal and abnormal values; paragraph 0155, "The patient's measurement may be indicated as above or below the norm as well as severity using color coding, iconography, or other indicator.").
As noted above, Jaramaz and Roh are directed toward similar methods of endeavor of surgical planning and execution. Cao is directed toward, “A method for analysis of spine anatomy and stenosis (abstract).” As can be easily seen by one of ordinary skill in the art before the effective filing date of the claimed invention, Jaramaz, Roh and Cao are directed toward similar methods of endeavor of spinal analysis and surgery. Further, one of ordinary skill in the art would be aware grading diseases allows for a physician to determine the level of a disease and further selecting optimal surgery for the severity of the disease. Thus, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teaching of Cao in order to provide a user with an indication of the level of disease present in a patient, further enhancing the specificity of a diagnosis and ultimately the treatment.
Double Patenting
Non-Statutory
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claim 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,207,882 (hereinafter US ‘882). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is more broad in scope than US ‘882.
Claim 1: Regarding claim 1, claim 1 compares to claim 1 of the US ‘882 patent as indicated below.
Instant Application - Claim 1
U.S. Patent No. 12,207,882 - Claim 1
Notes
A method for planning a surgical procedure comprising:
A method for planning a surgical procedure comprising:
Verbatim the same
receiving information corresponding to an examination of a patient and an image of a patient anatomy;
receiving, at a processor, information corresponding to an examination of a patient, the examination conducted by a user, wherein the information includes a pathology diagnosis from the user;
receiving, at the processor, an image of a patient anatomy;
Instant application more broad
processing the image of the patient anatomy to identify one or more features in the image and yield a processed image;
processing, using the processor, the image of the patient anatomy to identify one or more features in the image and yield a processed image;
Substantially the same
inputting the information and the processed image into an analytical model configured to identify, using artificial intelligence, a predicted location of an anatomical abnormality;
inputting, using the processor, the information and the processed image into an analytical model configured to identify, using artificial intelligence, a pathology location;
Substantially the same
comparing a feature of a first anatomical element at the predicted location of the anatomical abnormality with a corresponding feature of a second anatomical element at a different location, wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality;
comparing a feature of a first anatomical element at the pathology location with a corresponding feature of a second anatomical element at a different location, wherein the first anatomical element has an anatomical abnormality and the second anatomical element does not have the anatomical abnormality, and wherein the anatomical abnormality is a spinal stenosis;
Instant application more broad
automatically grading, using the processor, the spinal stenosis based on the comparison, wherein automatically grading the spinal stenosis includes grading the spinal stenosis on a numerical scale;
Instant application more broad
identifying, based on the predicted location of the anatomical abnormality and the comparison, a surgical modification of the first anatomical element; and
automatically identifying, with the processor and based on the pathology location, the comparison, and the graded spinal stenosis, a surgical modification of the first anatomical element;
Instant application more broad
automatically labeling, with the processor and based on the surgical modification, at least a portion of the first anatomical element in a three-dimensional model of the patient anatomy; and
Instant application more broad
generating, based on a determined surgical modification, machine readable instructions for at least one surgical step.
automatically generating, with the processor and based on the surgical modification, machine readable instructions for at least one surgical step.
Substantially the same
As can be seen above, claim 1 of the current application is more broad in scope than claim 1 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 1 of the US ‘882 patent.
Claim 2: Regarding claim 2, claim 2 compares to claim 2 of the US ‘882 patent as indicated below.
Instant Application - Claim 2
U.S. Patent No. 12,207,882 - Claim 2
Notes
The method of claim 1, wherein the surgical modification corresponds to removing a portion of the first anatomical element.
The method of claim 1, wherein the surgical modification corresponds to removing an identified portion of the first anatomical element.
Substantially the same
As can be seen above, claim 2 of the current application is more broad in scope (when incorporating dependency) than claim 2 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 2 of the US ‘882 patent.
Claim 3: Regarding claim 3, claim 3 compares to claim 3 of the US ‘882 patent as indicated below.
Instant Application - Claim 3
U.S. Patent No. 12,207,882 - Claim 3
Notes
The method of claim 1, wherein the surgical modification corresponds to a decompression procedure.
The method of claim 1, wherein the surgical modification corresponds to a decompression procedure.
Verbatim the same
As can be seen above, claim 3 of the current application is more broad in scope (when incorporating dependency) than claim 3 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 3 of the US ‘882 patent.
Claim 4: Regarding claim 4, claim 4 compares to claim 4 of the US ‘882 patent as indicated below.
Instant Application - Claim 4
U.S. Patent No. 12,207,882 - Claim 4
Notes
The method of claim 3, wherein the examination of the patient identifies an initial spinal level at which to perform the decompression procedure.
The method of claim 3, wherein the examination of the patient identifies an initial spinal level at which to perform the decompression procedure.
Verbatim the same
As can be seen above, claim 4 of the current application is more broad in scope (when incorporating dependency) than claim 4 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 4 of the US ‘882 patent.
Claim 5: Regarding claim 5, claim 5 compares to claim 5 of the US ‘882 patent as indicated below.
Instant Application - Claim 5
U.S. Patent No. 12,207,882 - Claim 5
Notes
The method of claim 1, further comprising:
The method of claim 1, further comprising:
Verbatim the same
receiving at least one medical record corresponding to the patient,
receiving, at the processor, at least one medical record corresponding to the patient,
Substantially the same
wherein the inputting further comprises inputting the at least one medical record into the analytical model.
wherein the inputting further comprises inputting the at least one medical record into the analytical model.
Verbatim the same
As can be seen above, claim 5 of the current application is more broad in scope (when incorporating dependency) than claim 5 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 5 of the US ‘882 patent.
Claim 6: Regarding claim 6, claim 6 compares to claim 6 of the US ‘882 patent as indicated below.
Instant Application - Claim 6
U.S. Patent No. 12,207,882 - Claim 6
Notes
The method of claim 1, wherein the image is obtained from a CT (computed tomography) scan or an MRI (magnetic resonance imaging) scan.
The method of claim 1, wherein the image is obtained from a computer tomography (CT) scan or a magnetic resonance imaging (MRI) scan.
Substantially the same
As can be seen above, claim 6 of the current application is more broad in scope (when incorporating dependency) than claim 6 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 6 of the US ‘882 patent.
Claim 7: Regarding claim 7, claim 7 compares to claim 7 of the US ‘882 patent as indicated below.
Instant Application - Claim 7
U.S. Patent No. 12,207,882 - Claim 7
Notes
The method of claim 1, wherein the image is a first image and the method further comprises:
The method of claim 1, wherein the image is a first image and the method further comprises:
Verbatim the same
receiving a second image; and
receiving, by the processor, a second image; and
Substantially the same
combining the first image and the second image.
automatically combining, by the processor, the first image and the second image.
Substantially the same
As can be seen above, claim 7 of the current application is more broad in scope (when incorporating dependency) than claim 7 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 7 of the US ‘882 patent.
Claim 8: Regarding claim 8, claim 8 compares to claim 8 of the US ‘882 patent as indicated below.
Instant Application - Claim 8
U.S. Patent No. 12,207,882 - Claim 8
Notes
The method of claim 7, wherein the first image comprises detailed soft tissue information and the second image comprises detailed bony tissue information.
The method of claim 7, wherein the first image comprises detailed soft tissue information and the second image comprises detailed bony tissue information.
Verbatim the same
As can be seen above, claim 8 of the current application is more broad in scope (when incorporating dependency) than claim 8 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 8 of the US ‘882 patent.
Claim 9: Regarding claim 9, claim 9 compares to claim 9 of the US ‘882 patent as indicated below.
Instant Application - Claim 9
U.S. Patent No. 12,207,882 - Claim 9
Notes
The method of claim 1, wherein the information includes results of one or more of a soft tissue tenderness test, a range of motion test, or a straight leg raise test.
The method of claim 1, wherein the information includes results of one or more of a soft tissue tenderness test, a range of motion test, or a straight leg raise test.
Verbatim the same
As can be seen above, claim 9 of the current application is more broad in scope (when incorporating dependency) than claim 9 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 9 of the US ‘882 patent.
Claim 10: Regarding claim 10, claim 10 compares to claim 1 of the US ‘882 patent as indicated below.
Instant Application - Claim 10
U.S. Patent No. 12,207,882 - Claim 1
Notes
The method of claim 1, wherein the anatomical abnormality is a spinal stenosis.
…. wherein the anatomical abnormality is a spinal stenosis;
Verbatim the same
As can be seen above, claim 10 of the current application is more broad in scope (when incorporating dependency) than claim 1 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 1 of the US ‘882 patent.
Claim 11: Regarding claim 11, claim 11 compares to claim 1 of the US ‘882 patent as indicated below.
Instant Application - Claim 11
U.S. Patent No. 12,207,882 - Claim 1
Notes
The method of claim 10, further comprising: grading the spinal stenosis on a numerical scale based on the comparison.
… wherein automatically grading the spinal stenosis includes grading the spinal stenosis on a numerical scale
Substantially the same
As can be seen above, claim 11 of the current application is more broad in scope (when incorporating dependency) than claim 1 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 1 of the US ‘882 patent.
Claim 12: Regarding claim 12, claim 12 compares to claim 10 of the US ‘882 patent as indicated below.
Instant Application - Claim 12
U.S. Patent No. 12,207,882 - Claim 10
Notes
The method of claim 11, wherein grading the spinal stenosis includes further grading the spinal stenosis on a color intensity scale.
The method of claim 1, wherein automatically grading the spinal stenosis includes further grading the spinal stenosis on a color intensity scale.
Substantially the same
As can be seen above, claim 12 of the current application is more broad in scope (when incorporating dependency) than claim 10 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 10 of the US ‘882 patent.
Claim 13: Regarding claim 13, claim 13 compares to claim 11 of the US ‘882 patent as indicated below.
Instant Application - Claim 13
U.S. Patent No. 12,207,882 - Claim 11
Notes
The method of claim 1, wherein identifying the predicted location of the anatomical abnormality includes an analysis of how spinal nerves are spread out in the image of the patient anatomy.
The method of claim 1, wherein identifying the pathology location includes an analysis of how spinal nerves are spread out in the image of the patient anatomy.
Substantially the same
As can be seen above, claim 13 of the current application is more broad in scope (when incorporating dependency) than claim 11 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 11 of the US ‘882 patent.
Claim 14: Regarding claim 14, claim 14 compares to claim 12 of the US ‘882 patent as indicated below.
Instant Application - Claim 14
U.S. Patent No. 12,207,882 - Claim 12
Notes
A method for planning a decompression procedure comprising:
A method for planning a decompression procedure comprising:
Verbatim the same
receiving, at a processor from a first database, information corresponding to a patient examination, the information comprising information other than an image;
receiving, at a processor from a first database, information corresponding to a patient examination, the information comprising information other than an image, and wherein the information includes text corresponding to a pathology diagnosis from a user;
Instant application more broad
receiving, at the processor from a second database, an image of a spinal region of a patient;
receiving, at the processor from a second database, an image of a spinal region of a patient;
Substantially the same
identifying, with the processor, a location of an anatomical abnormality in the spinal region;
identifying a location of an anatomical abnormality in the spinal region;
Substantially the same
comparing, with the processor, a feature of a first anatomical element at the location of the anatomical abnormality with a corresponding feature of a second anatomical element at a different location, wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality;
comparing a feature of a first anatomical element at the location of the anatomical abnormality with a corresponding feature of a second anatomical element at a different location, wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality, and wherein the anatomical abnormality is a spinal stenosis;
Instant application more broad
identifying, with the processor and using artificial intelligence, the location of the anatomical abnormality based on the information and the comparison;
identifying, with the processor and using artificial intelligence, a location of the spinal stenosis based on the information and the comparison; and
Substantially the same
automatically grading, using the processor, the spinal stenosis based on the comparison, wherein automatically grading the spinal stenosis includes grading the spinal stenosis on a color intensity scale;
Instant application more broad
identifying, with the processor and based on the location of the anatomical abnormality and the comparison, a surgical modification of the first anatomical element; and
automatically identifying, with the processor and based on the location of the anatomical abnormality, the comparison, and the graded spinal stenosis, a surgical modification of the first anatomical element; and
Instant application more broad
generating, with the processor and based on the surgical modification, machine readable instructions for at least one surgical step.
automatically generating, with the processor and based on the surgical modification, machine readable instructions for at least one surgical step.
Substantially the same
As can be seen above, claim 14 of the current application is more broad in scope (when incorporating dependency) than claim 12 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 12 of the US ‘882 patent.
Claim 15: Regarding claim 15, claim 15 compares to claim 13 of the US ‘882 patent as indicated below.
Instant Application - Claim 15
U.S. Patent No. 12,207,882 - Claim 13
Notes
The method of claim 14, further comprising: labeling, with the processor and in a model of the spinal region of the patient, a portion of at least one vertebra to remove during the decompression procedure.
The method of claim 12, further comprising:
automatically labeling, with the processor and in a model of the spinal region of the patient, a portion of at least one vertebra to remove during the decompression procedure targeting the spinal stenosis.
Instant application more broad
As can be seen above, claim 15 of the current application is more broad in scope (when incorporating dependency) than claim 13 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 13 of the US ‘882 patent.
Claim 16: Regarding claim 16, claim 16 compares to claim 15 of the US ‘882 patent as indicated below.
Instant Application - Claim 16
U.S. Patent No. 12,207,882 - Claim 15
Notes
The method of claim 14, further comprising: determining a spinal level at which to perform the decompression procedure.
The method of claim 12, further comprising: determining a spinal level at which to perform the decompression procedure based on the location of the spinal stenosis.
Substantially the same
As can be seen above, claim 16 of the current application is more broad in scope (when incorporating dependency) than claim 15 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 15 of the US ‘882 patent.
Claim 17: Regarding claim 17, claim 17 compares to claim 16 of the US ‘882 patent as indicated below.
Instant Application - Claim 17
U.S. Patent No. 12,207,882 – Claims 1 and 16
Notes
The method of claim 14, wherein the anatomical abnormality comprises spinal stenosis, and further comprising determining whether the spinal stenosis is a lateral stenosis or a central stenosis.
Claim 1: …. and wherein the anatomical abnormality is a spinal stenosis
Claim 16: The method of claim 12, further comprising determining whether the spinal stenosis is a lateral stenosis or a central stenosis.
Substantially the same
As can be seen above, claim 17 of the current application is more broad in scope (when considering dependency) than claim 16 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 16 of the US ‘882 patent.
Claim 18: Regarding claim 18, claim 18 compares to claim 17 of the US ‘882 patent as indicated below.
Instant Application - Claim 18
U.S. Patent No. 12,207,882 - Claim 17
Notes
The method of claim 14, further comprising:
The method of claim 12, further comprising
segmenting, with the processor, the spinal region as depicted in the image to define boundaries of individual elements of the spinal region; and
segmenting, with the processor, the spinal region as depicted in the image to define boundaries of individual elements of the spinal region; and
Verbatim the same
identifying, with the processor, one or more spinal nerves in the image.
identifying, with the processor, one or more spinal nerves in the image.
Verbatim the same
As can be seen above, claim 18 of the current application is more broad in scope (when incorporating dependency) than claim 17 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 17 of the US ‘882 patent.
Claim 19: Regarding claim 19, claim 19 compares to claim 14 of the US ‘882 patent as indicated below.
Instant Application - Claim 19
U.S. Patent No. 12,207,882 - Claim 14
Notes
The method of claim 14, wherein the at least one surgical step corresponds to removing an identified portion of at least one vertebra.
The method of claim 13, wherein the at least one surgical step corresponds to removing an identified portion of the at least one vertebra.
Verbatim the same
As can be seen above, claim 19 of the current application is more broad in scope than claim 14 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 14 of the US ‘882 patent.
Claim 20: Regarding claim 20, claim 20 compares to claim 18 of the US ‘882 patent as indicated below.
Instant Application - Claim 20
U.S. Patent No. 12,207,882 - Claim 18
Notes
A system for performing a decompression procedure comprising:
A system for performing a decompression procedure comprising:
Verbatim the same
an interface;
an interface;
Verbatim the same
at least one processor; and
at least one processor; and
Verbatim the same
a memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to:
a memory storing instructions for execution by the at least one processor that, when executed, cause the at least one processor to:
Verbatim the same
receive, via the interface, information corresponding to a patient examination, the information comprising information other than an image;
receive, via the interface, information corresponding to a patient examination, the information comprising information other than an image;
Verbatim the same
receive a three-dimensional image of at least a portion of an anatomy of a patient;
receive a three-dimensional image of at least a portion of an anatomy of a patient;
Verbatim the same
identify, using artificial intelligence, a predicted location of an anatomical abnormality;
identify, using artificial intelligence, a predicted location of an anatomical abnormality, wherein the anatomical abnormality is a spinal stenosis;
Instant application more broad
compare a feature of a first anatomical element at the predicted location of the anatomical abnormality with a corresponding feature of a second anatomical element at a different location, wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality;
compare a feature of a first anatomical element at the predicted location of the anatomical abnormality with a corresponding feature of a second anatomical element at a second location, wherein the first anatomical element has the anatomical abnormality and the second anatomical element does not have the anatomical abnormality;
Substantially the same
automatically grade, using the processor, the spinal stenosis based on the comparison, wherein automatically grading the spinal stenosis includes grading the spinal stenosis on a numerical scale and a color intensity scale; and
Instant application more broad
identify, based on the comparison, a surgical modification of the first anatomical element; and
automatically label, in the three-dimensional image and based on the predicted location, the comparison, and the graded spinal stenosis, a portion of the first anatomical element to surgically modify; and
Instant application more broad
generate machine-readable instructions for at least one surgical step of the surgical modification.
automatically generate, using the processor and based on the portion of the first anatomical element to surgically modify, machine readable instructions for at least one surgical step.
Instant application more broad
As can be seen above, claim 20 of the current application is more broad in scope than claim 18 of the US ‘882 patent. Therefore, any patent granted on the current application would result in the un justifiable timewise extension of the monopoly granted on claim 18 of the US ‘882 patent.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
U.S. Publication No. 2020/0138518 to Lang discloses, “Aspects of the invention relate to systems, devices and methods for performing a surgical step or surgical procedure with visual guidance (abstract)”
U.S. Publication No. 2016/0028998 to Deitz et al. discloses, “the present invention include: (1) a software device for reporting measurement output of the measurement system and for allowing users to interact with the measurement output data; (2) an apparatus and method for utilizing measurement output of the measurement system for therapeutic and surgical applications such as surgical navigation and patient positioning during a therapeutic procedure; and (3) an apparatus providing input image data for the measurement system that assists with the imaging of joints connecting anatomical regions that are in motion during operation (abstract).”
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Courtney J. Windsor whose telephone number is (571)272-3956. The examiner can normally be reached Monday - Friday 8:00 - 4:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, John Villecco can be reached at 571-272-7319. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/COURTNEY JOAN NELSON/Primary Examiner, Art Unit 2661
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