DETAILED ACTION
Summary
Claims 1-18 are pending in the application. Claims 5, 7, and 9-11 rejected under 35 U.S.C. 112(b). Claims 1-18 are rejected under 35 USC 101. Claims 1-18 are rejected under 35 USC 103.
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 filed 5/26/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. No copies of the foreign patent document “WO2020038917A1” or the non-patent literature “Kronke Sven et al.” were provided.
Claim Objections
Claims 1-3, 7-8, 12-15, and 17 objected to because of the following informalities:
Claim 1 recites “3D” in line 5. It should recite “three-dimensional (3D)”.
Claim 1 recites “the pose” in line 8. It should recite “a pose”.
Claim 2 recites “the X-ray image” in lines 11-12. It should recite “the first X-ray image”.
Claim 3 recites “the pose” in line 8. It should recite “a pose”.
Claim 7 recites “The computer program product of any one or claim 1” in lines 1-2. It should recite “The computer program product of claim 1”.
Claim 8 recites “The computer program product of any one of claim 1” in lines 1-2. It should recite “the computer program product of claim 1”.
Claim 12 recites “the computer program” in line 2. It should recite “the computer program product”.
Claim 13 recites “an augmented-reality device” in lines 1-2. It should recite “the augmented-reality device”.
Claim 14 recites “an imaging device” in line 2. It should recite “the imaging device”.
Claim 15 recites “3D” in line 5. It should recite “three-dimensional (3D)”.
Claim 15 recites “the pose” in line 8. It should recite “a pose”.
Claim 17 recites “the pose” in line 8. It should recite “a pose”.
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.
Claims 5, 7, and 9-11 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.
Claim 5 recites the limitation "the 3D representation" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “a 3D representation”.
Claim 5 recites the limitation "the second object" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “a second object”.
Claim 7 recites the limitation "the 3D representation" in line 4-5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “a 3D representation”.
Claim 7 recites the limitation "the second object" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “a second object”.
Claim 7 recites the limitation "the tool" in line 5. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as recites “a tool”.
Claim 9 recites the limitation "the second object" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “a second object”.
Claim 9 recites “the information” in line 4. It is not clear if this is referring to the information of the pose of the imaging device or the information of the predetermined position and/or orientation of the at least one of the first object and the second object. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 10 recites “the information” in line 4. It is not clear if this is referring to the information of the pose of the imaging device or the information how to reach the predetermined position and/or orientation. Clarification is required. For the purposes of examination, the latter definition will be used.
Claim 11 recites the limitation "the treatment" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “a treatment”.
Claim 11 recites the limitation "the bone" in line 3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, the claim will be interpreted as reciting “a treatment”.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11, and 17-18 rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because they are directed to a computer program per se.
Claims 1-11 and 17-18 are directed to a “computer program product”. This is directed to a computer program per se, as there are no structural components recited. A computer program is not one of the four statutory categories, and therefore the claims are not subject matter eligible. The Examiner recommends adding language such as “a non-transitory computer readable medium storing a computer program product…” in order to add structural components to the claims.
Claims 1-18 rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) an abstract idea of a mental process. This judicial exception is not integrated into a practical application because the additional limitations are directed to insignificant extra-solution activities and recite generic computer components. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional limitations are directed to insignificant extra-solution activities and recite generic computer components.
Claim 1 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The steps of “determining an imaging direction” and “determining a position and orientation of a first object” are directed to a mental process type abstract idea. A user, looking at an X-ray image and thinking about a 3D representation of the first object, can determine the image direction of the first X-ray image using only their mind. A user could further determine a position and orientation of the first object based on a registration using only their mind. The claim recites an abstract idea.
The claim does not contain limitations which, when viewed individually or as an ordered combination, integrate the abstract idea into a practical application. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system. The steps of receiving a first X-ray image or receiving information of the pose are insignificant extra-solution activities of data gathering, which does not integrate the abstract idea into a practical application. The claim is not subject matter eligible. The claim is not significantly more than the judicial exception. As detailed above, the additional limitations are just mere instructions to implement the abstract idea onto a generic computer system, or insignificant extra-solution activities. The claim is not subject matter eligible.
Claim 2 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The steps of eliminating the degrees of freedom of the tool and the object related to the tool is directed to a mental process. A user, looking at the image, could decide which degrees of freedom of the objects should be eliminated using only their mind. Furthermore a user, looking at the image, can identify a geometrical aspect in the coordinate system using only their mind. The claim recites an abstract idea. The additional limitation of the X-ray image showing a tool is further narrowing the extra-solution activity of gathering data, and neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system, which neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 3 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The steps of “determining an imaging direction” and “determining a position and orientation of the second object” are directed to a mental process type abstract idea. A user, looking at an X-ray image and thinking about a 3D representation of the second object, can determine the image direction of the first X-ray image using only their mind. A user could further determine a position and orientation of the second object based on a registration using only their mind. The claim recites an abstract idea.
The claim does not contain limitations which, when viewed individually or as an ordered combination, integrate the abstract idea into a practical application. The “computer program product” is a generic computer component, and is not more than mere instructions to implement the abstract idea on a generic computer system. The steps of receiving a second X-ray image or receiving information of the pose are insignificant extra-solution activities of data gathering, which does not integrate the abstract idea into a practical application. The claim is not subject matter eligible. The claim is not significantly more than the judicial exception. As detailed above, the additional limitations are just mere instructions to implement the abstract idea onto a generic computer system, or insignificant extra-solution activities. The claim is not subject matter eligible.
Claim 4 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The step of determining a position and orientation is directed to an abstract idea of a mental process. A user, additionally looking at the a priori information, can determine the position and orientation using only their mind. The additional limitations do not integrate the abstract idea into a practical application. The step of receiving a priori information is directed to an insignificant extra solution activity of data gathering, and neither integrates the abstract idea into a practical application nor amounts to significantly more than the abstract idea. The computer program product is a generic computer component, and is no more than mere instructions to implement the abstract idea onto a generic computer system, and neither integrates the abstract idea into a practical application nor amounts to significantly more than the abstract idea. The claim is not patent eligible.
Claim 5 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The step of generating a 3D representation of the first object is directed to an insignificant extra solution activity of outputting data, and does not integrate the abstract idea into a practical application. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system. The claim is directed to an abstract idea. The claim is not significantly more than the judicial exception. As detailed above, the additional limitations are mere instructions to implement the abstract idea using generic computer components and insignificant extra solution activity of outputting data. The claim is not subject matter eligible.
Claim 6 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The step of determining one aspect from the group is directed to an abstract idea of a mental process. A user, looking at the image, can determine one of those aspects using only their mind. The claim recites an abstract idea. The additional limitation of the first and second objects being bone fragments further narrowing the extra-solution activity of gathering data, and neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system, which neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 7 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The step of providing a visualization to an augmented reality device is directed to an insignificant extra-solution activity of outputting data, which does not integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system, which neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 8 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The step of determining an insertion path is directed to an abstract idea of a mental process. As user, looking at an x-ray image, could determine an insertion path using only their mind. The claim recites an abstract idea. The additional features, when viewed alone or as an ordered combination, do not amount to significantly more than the judicial exception. The step of providing a visualization to an augmented reality device is directed to an insignificant extra-solution activity of outputting data, which does not integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system, which neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 9 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The additional features, when viewed alone or as an ordered combination, do not amount to significantly more than the judicial exception. The step of receiving information is directed to an insignificant extra-solution activity of data gathering, which does not integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The step of providing a visualization to an augmented reality device is directed to an insignificant extra-solution activity of outputting data, which does not integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system, which neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 10 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The additional features, when viewed alone or as an ordered combination, do not amount to significantly more than the judicial exception. The step of receiving information is directed to an insignificant extra-solution activity of data gathering, which does not integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The step of providing information is directed to an insignificant extra-solution activity of outputting data, which does not integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system, which neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 11 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The step of identifying a current status of the treatment is directed to an abstract idea of a mental process. As user could identify what stage of treatment of the bone they are performing using only their mind. The claim recites an abstract idea. The additional features, when viewed alone or as an ordered combination, do not amount to significantly more than the judicial exception. The step of providing information is directed to an insignificant extra-solution activity of outputting data, which does not integrate the abstract idea into a practical application or amount to significantly more than the judicial exception. The “computer program product” is a generic computer component, and is no more than instructions to implement the abstract idea on a generic computer system, which neither integrates the abstract idea into a practical application nor amounts to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 12 is not subject matter eligible. The additional limitations do not integrate the abstract idea into a practical application. The inclusion of a “processing unit” is a generic computer component, and it amounts to no more than mere instructions to implement the abstract idea using a generic computer system, which neither integrates the abstract idea into a practical application or amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 13 is not subject matter eligible. The additional limitation of an augmented reality device is a field of use limitation that just generally links the recited abstract idea to a particular field of use, which neither integrates the abstract idea into a practical application nor amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 14 is not subject matter eligible. The additional limitation of an imaging device is a field of use limitation that just generally links the recited abstract idea to a particular field of use, which neither integrates the abstract idea into a practical application nor amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 15 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The steps of “determining an imaging direction” and “determining a position and orientation of a first object” are directed to a mental process type abstract idea. A user, looking at an X-ray image and thinking about a 3D representation of the first object, can determine the image direction of the first X-ray image using only their mind. A user could further determine a position and orientation of the first object based on a registration using only their mind. The claim recites an abstract idea.
The claim does not contain limitations which, when viewed individually or as an ordered combination, integrate the abstract idea into a practical application. The steps of receiving a first X-ray image or receiving information of the pose are insignificant extra-solution activities of data gathering, which does not integrate the abstract idea into a practical application. The claim is not subject matter eligible. The claim is not significantly more than the judicial exception. As detailed above, the additional limitations are insignificant extra-solution activities. The claim is not subject matter eligible.
Claim 16 is not subject matter eligible. The additional limitation of an imaging device is a field of use limitation that just generally links the recited abstract idea to a particular field of use, which neither integrates the abstract idea into a practical application nor amount to significantly more than the judicial exception. The claim is not subject matter eligible.
Claim 17 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The steps of “determining an imaging direction” and “determining a position and orientation of the second object” are directed to a mental process type abstract idea. A user, looking at an X-ray image and thinking about a 3D representation of the second object, can determine the image direction of the first X-ray image using only their mind. A user could further determine a position and orientation of the second object based on a registration using only their mind. The claim recites an abstract idea.
The claim does not contain limitations which, when viewed individually or as an ordered combination, integrate the abstract idea into a practical application. The “computer program product” is a generic computer component, and is not more than instructions to implement the abstract idea on a generic computer system. The steps of receiving a second X-ray image or receiving information of the pose are insignificant extra-solution activities of data gathering, which does not integrate the abstract idea into a practical application. The claim is not subject matter eligible. The claim is not significantly more than the judicial exception. As detailed above, the additional limitations are just mere instructions to implement the abstract idea onto a generic computer system, or insignificant extra-solution activities. The claim is not subject matter eligible.
Claim 18 is not directed to statutory subject matter. However, even if the claim was amended to be directed to statutory subject matter, the claim would still be directed to an abstract idea without significantly more. The step of determining a position and orientation is directed to an abstract idea of a mental process. A user, additionally looking at the a priori information, can determine the position and orientation using only their mind. The additional limitations do not integrate the abstract idea into a practical application. The step of receiving a priori information is directed to an insignificant extra solution activity of data gathering, and neither integrates the abstract idea into a practical application nor amounts to significantly more than the abstract idea. The computer program product is a generic computer component, and is no more than mere instructions to implement the abstract idea onto a generic computer system, and neither integrates the abstract idea into a practical application nor amounts to significantly more than the abstract idea. The claim is not patent eligible.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (U.S PGPub 2020/0275988 A1) in view of Blau (EP2801320A1).
Regarding Claim 1, Johnson teaches a computer program product being executable on a processing unit of a system [0122]-[0123], the computer program product including sets of instructions for
receiving a first X-ray image showing a first object [0055], the first X-ray image being generated by an imaging device [0055],
the imaging direction of the first X-ray image being associated with a coordinate system of the first X-ray image [0079] (the source/detector location defines the imaging direction, the coordinate system of the marker is the coordinate system of the image [0075]),
receiving information of the pose of the imaging device at which pose the first X-ray image has been generated (Fig. 11, CTHMB) [0070]+[0074]+[0082], wherein the information includes a geometrical aspect of the imaging device [0084] (source to detector) and is provided by an augmented-reality device associated with a global coordinate system (Fig. 11, WTHMD) [0074]+[0079]-[0081],
determining a position and orientation of the first object relative to the global coordinate system [0097] based on a registration of the coordinate system of the first X-ray image with the global coordinate system [0097] (the system localizes (i.e. determines position and orientation) of objects in the image based on the registration).
Johnson fails to explicitly teach determining an imaging direction of the first X-ray image based on a 3D representation of the first object.
Blau teaches a system for using a reference body to determine an imaging direction (Abstract). This system obtains an image of an object [0039], and then uses the 3D representation of the object to determine the imaging direction [0041]-[0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Johnson to use a 3D representation of the first action to determine an imaging direction, as taught by Blau, because this more efficiently adjust a C-arm and reduce the amount of radiation exposed to the patient, thereby increasing the safety of the procedure, as recognized by Blau [0006].
Regarding Claim 12, the combination of references teaches the invention substantially as claimed. Johnson further teaches a system comprising a processing unit [0123], wherein the processing unit is configured to execute the computer program [0122]-[0123] according to claim 1 (See rejection of claim 1 above).
Regarding Claim 13, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the system further comprises an augmented-reality device [0043].
Regarding Claim 14, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the system further comprises an imaging device [0043]+[0055].
Regarding Claim 15, Johnson teaches a method assisting in a musculoskeletal procedure [0055], the method comprising steps of
receiving a first X-ray image showing a first object [0055], the first X-ray image being generated by an imaging device [0055],
the imaging direction of the first X-ray image being associated with a coordinate system of the first X-ray image [0079] (the source/detector location defines the imaging direction, the coordinate system of the marker is the coordinate system of the image [0075]),
receiving information of the pose of the imaging device at which pose the first X-ray image has been generated (Fig. 11, CTHMB) [0070]+[0074]+[0082], wherein the information includes a geometrical aspect of the imaging device [0084] (source to detector) and is provided by an augmented-reality device associated with a global coordinate system (Fig. 11, WTHMD) [0074]+[0079]-[0081],
determining a position and orientation of the first object relative to the global coordinate system [0097] based on a registration of the coordinate system of the first X-ray image with the global coordinate system [0097] (the system localizes (i.e. determines position and orientation) of objects in the image based on the registration).
Johnson fails to explicitly teach determining an imaging direction of the first X-ray image based on a 3D representation of the first object.
Blau teaches a system for using a reference body to determine an imaging direction (Abstract). This system obtains an image of an object [0039], and then uses the 3D representation of the object to determine the imaging direction [0041]-[0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Johnson to use a 3D representation of the first action to determine an imaging direction, as taught by Blau, because this more efficiently adjust a C-arm and reduce the amount of radiation exposed to the patient, thereby increasing the safety of the procedure, as recognized by Blau [0006].
Regarding Claim 16, the combination of references teaches the invention substantially as claimed. Johnson further teaches wherein the system further comprises an imaging device [0043]+[0055].
Claims 2, 10, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Blau as applied to claim 1 above, and further in view of Fischer et al. (U.S PGPub 2019/0192100 A1) and Blau (U.S PGPub 2021/0248779 A1) (Blau’779).
Regarding Claim 2, the combination of references teaches the invention substantially as claimed. Johnson further teaches identifying a geometrical aspect in the coordinate system of the first X-ray image [0084] (anatomical landmarks), wherein the determination of the position and orientation of the first object relative to the global coordinate system [0097] is further based on a relationship between the geometrical aspect of the imaging device and the geometrical aspect in the coordinate system of the X-ray image [0084]+[0096]-[0097] (spatial relation between source to detector and landmark is used as a world lock and to localize the information).
Johnson fails to explicitly teach wherein the first X-ray image further shows a tool, the computer program product further including sets of instructions for eliminating two degrees of freedom of the position and orientation of the tool in the global coordinate system.
Fischer teaches a method for aligning an instrument relative to an object during a treatment procedure (Abstract). This system has an X-ray image [0011] which further shows the tool [0070]. This system further contains a computer program product [0056] further including sets of instructions for eliminating two degrees of freedom of the position and orientation of the tool in the global coordinate system [0012]+[0020]+[0032] (not relevant degrees of freedom can be considered eliminated).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to eliminate degrees of freedom from the tool, as taught by Fischer, as this allows for accurate registration using fewer working images, thereby reducing radiation exposure and increasing the safety of the procedure, as recognized by Fischer [0038]. While Fischer does explicitly teach eliminating two degrees of freedom, it would have been obvious to one of ordinary skill in the art to eliminate two degrees of freedom through routine experimentation in determining which degrees of freedom are relevant, and which are not relevant, as recognized by Fischer [0032].
Fischer is silent regarding eliminating two degrees of freedom of the position and orientation of the first object relative to the tool.
Blau’779 teaches a system for determining relative positions between objects in X-ray images (Abstract). This system eliminates 2 DoF between the position of the first object and the tool [0122].
It would have been obvious to one of ordinary skill in the art to eliminate 2 DoF of the first object relative to the tool, as taught by Blau’779, because this allows for a sufficiently accurate determination of the position of the drill tip, thereby increasing the safety of the procedure, as recognized by Blau’779 [0120]-[0122].
Regarding Claim 10, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach the computer program product further including sets of instructions for receiving information how to reach a predetermined position and/or orientation of the tool or of the imaging device, and to provide the information.
Blau’779 further teaches the computer program product further including sets of instructions for receiving information how to reach a predetermined position and/or orientation of the tool or of the imaging device [0209] (target trajectory), and to provide the information [0209].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to obtain provide information on how to reach a predetermined position, as taught by Blau’779, because it increases the safety and accuracy of procedure, as recognized by Blau’779 [0016].
Regarding Claim 17, the combination of references teaches the invention substantially as claimed. Johnson further teaches the computer program product [0122]-[0123] further including sets of instructions for receiving a second X-ray image [0087] (the system can occur for different images from different C arm poses, the second X-ray image being generated by the imaging device [0055],
the imaging direction of the second X-ray image being associated with a coordinate system of the second X-ray image [0079] (the source/detector location defines the imaging direction, the coordinate system of the marker is the coordinate system of the image [0075]),
receiving information of the pose of the imaging device at which pose the second X-ray image has been generated (Fig. 11, CTHMB) [0070]+[0074]+[0082], wherein the information includes the or another geometrical aspect of the imaging device [0084] (source to detector) and is provided by the augmented-reality device associated with the global coordinate system (Fig. 11, WTHMD) [0074]+[0079]-[0081],
a registration of the coordinate system of the second X-ray image with the global coordinate system [0097] (the system localizes (i.e. determines position and orientation) of objects in the image based on the registration).
Johnson fails to explicitly teach determining an imaging direction of the first X-ray image based on a 3D representation of the first object.
Blau teaches a system for using a reference body to determine an imaging direction (Abstract). This system obtains an image of an object [0039], and then uses the 3D representation of the object to determine the imaging direction [0041]-[0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Johnson to use a 3D representation of the first action to determine an imaging direction, as taught by Blau, because this more efficiently adjust a C-arm and reduce the amount of radiation exposed to the patient, thereby increasing the safety of the procedure, as recognized by Blau [0006].
The combination fails to explicitly teach a second object, or determining a position and orientation of the second object relative to the first object based.
Blau’779 teaches a system for processing X-ray images (Abstract). This system takes a second image of a second object [0066]-[0067]. This system determines the position and orientation of the first object relative to the second object [0113]. This system registers the different X-ray images together [0136]-[0137].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to obtain an image of a second object and determine the position and orientation of the second object relative to the first object, as taught by Blau’779, because it increases the safety and accuracy of procedures to know the relative positions of different objects during a surgery, as recognized by Blau’779 [0016]. One of ordinary skill would recognize that, as the system of Johnson registers the different systems in the global coordinate system, the combined system would similarly register the different systems in the global coordinate system.
Regarding Claim 18, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach the computer program product further including sets of instructions for receiving a priori information of the position and orientation of the second object relative to the first object, wherein the determination of the position and orientation of the second object relative to the first object is further based on the a priori information of the position and orientation of the second object relative to the first object.
Blau’779 further teaches computer program product [0002] further including sets of instructions for receiving a priori information of the position and orientation of the second object relative to the first object [0054], wherein the determination of the position and orientation of the second object relative to the first object is further based on the a priori information of the position and orientation of the second object relative to the first object [0113].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to use a priori information for determining the position and orientation of the second object, as taught by Blau’779 because this allows for a more accurate determination of the relative positions, as recognized by Blau’779 [0107].
Claims 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Blau as applied to claim 1 above, and further in view of Blau (U.S PGPub 2021/0248779 A1) (Blau’779).
Regarding Claim 3, the combination of references teaches the invention substantially as claimed. Johnson further teaches the computer program product [0122]-[0123] further including sets of instructions for
receiving a second X-ray image [0087] (the system can occur for different images from different C arm poses), the second X-ray image being generated by the imaging device [0055],
the imaging direction of the second X-ray image being associated with a coordinate system of the second X-ray image [0079] (the source/detector location defines the imaging direction, the coordinate system of the marker is the coordinate system of the image [0075]),
receiving information of the pose of the imaging device at which pose the second X-ray image has been generated (Fig. 11, CTHMB) [0070]+[0074]+[0082], wherein the information includes the or another geometrical aspect of the imaging device [0084] (source to detector) and is provided by the augmented-reality device associated with the global coordinate system (Fig. 11, WTHMD) [0074]+[0079]-[0081],
a registration of the coordinate system of the second X-ray image with the global coordinate system [0097] (the system localizes (i.e. determines position and orientation) of objects in the image based on the registration).
Johnson fails to explicitly teach determining an imaging direction of the first X-ray image based on a 3D representation of the first object.
Blau teaches a system for using a reference body to determine an imaging direction (Abstract). This system obtains an image of an object [0039], and then uses the 3D representation of the object to determine the imaging direction [0041]-[0042].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of Johnson to use a 3D representation of the first action to determine an imaging direction, as taught by Blau, because this more efficiently adjust a C-arm and reduce the amount of radiation exposed to the patient, thereby increasing the safety of the procedure, as recognized by Blau [0006].
The combination fails to explicitly teach a second object, or determining a position and orientation of the second object relative to the first object based.
Blau’779 teaches a system for processing X-ray images (Abstract). This system takes a second image of a second object [0066]-[0067]. This system determines the position and orientation of the first object relative to the second object [0113]. This system registers the different X-ray images together [0136]-[0137].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to obtain an image of a second object and determine the position and orientation of the second object relative to the first object, as taught by Blau’779, because it increases the safety and accuracy of procedures to know the relative positions of different objects during a surgery, as recognized by Blau’779 [0016]. One of ordinary skill would recognize that, as the system of Johnson registers the different systems in the global coordinate system, the combined system would similarly register the different systems in the global coordinate system.
Regarding Claim 4, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach the computer program product further including sets of instructions for receiving a priori information of the position and orientation of the second object relative to the first object, wherein the determination of the position and orientation of the second object relative to the first object is further based on the a priori information of the position and orientation of the second object relative to the first object.
Blau’779 further teaches computer program product [0002] further including sets of instructions for receiving a priori information of the position and orientation of the second object relative to the first object [0054], wherein the determination of the position and orientation of the second object relative to the first object is further based on the a priori information of the position and orientation of the second object relative to the first object [0113].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to use a priori information for determining the position and orientation of the second object, as taught by Blau’779 because this allows for a more accurate determination of the relative positions, as recognized by Blau’779 [0107].
Regarding Claim 5, the combination of references teaches the invention substantially as claimed. Johnson further teaches the computer program product further including sets of instructions for generating at least one of the 3D representation of the first object [0047]+[0102].
Johnson fails to explicitly teach the 3D representation of the second object.
Blau’779 teaches the 3D representation of the second object [0226].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to perform a 3D reconstruction of the second object, as taught by Blau’779, because it increases the safety and accuracy of procedures to know the relative positions of different objects during a surgery, as recognized by Blau’779 [0016].
Regarding Claim 6, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach wherein the first object is a first fragment of a fractured bone and wherein the second object is a second fragment of the fractured bone, and wherein the computer program product further includes sets of instructions for determining at least one aspect out of the group consisting of a bone length, an angle of anteversion, an angle of version, a centrum-collum-diaphyseal (CCD) angle, and a bone curvature.
Blau’779 further teaches wherein the first object is a first fragment of a fractured bone and wherein the second object is a second fragment of the fractured bone [0310], and wherein the computer program product further includes sets of instructions for determining at least one aspect out of the group consisting of a bone length, a centrum-collum-diaphyseal (CCD) angle [0107].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to determine bone length or CCD, as taught by Blau’779, because knowing the relative positions of different objects during a surgery increases the safety and accuracy of procedures, as recognized by Blau’779 [0016].
Claims 7-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Blau as applied to claim 1 above, and further in view of Lang (U.S PGPub 2021/0192759 A1).
Regarding Claim 7, the combination of references teaches the invention as claimed. Johnson further teaches the computer program product further including sets of instructions for providing a visualization on the augmented-reality device [0006].
Johnson fails to explicitly teach wherein the visualization is at least one out of the group consisting of the 3D representation of the first object, the 3D representation of the second object and the tool, and wherein the visualization is shown at the position and orientation as determined in the global coordinate system.
Lang teaches a system for performing surgery with a visual guidance on a head-mounted display (Abstract). This system wherein the visualization is at least one out of the group consisting of the 3D representation of the first object, the 3D representation of the second object and the tool [0307]+[0314] (displays representation of the tool) (Fig. 11, 151) [1065]-[1066], and wherein the visualization is shown at the position and orientation as determined in the global coordinate system (Fig. 1, 15) [0217].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to display 3D representations at the augmented reality device, as taught by Lang, because this allows the surgeon to better perform the surgical procedure, thereby increasing the efficacy of the procedure, as recognized by Lang [1491].
Regarding Claim 8, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach the computer program product further including sets of instructions for determining an insertion path for a tool or an implant, and for providing a visualization of the insertion path on the augmented-reality device, wherein the insertion path is shown at the position and orientation as determined in the global coordinate system.
Lang teaches a system for performing surgery on a head-mounted display (Abstract). This system has a computer program product further including sets of instructions for determining an insertion path for a tool or an implant [1466], and for providing a visualization of the insertion path on the augmented-reality device [1466], wherein the insertion path is shown at the position and orientation as determined in the global coordinate system (Fig. 1, 15) [0217].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to display an insertion path, as taught by Lang, because this allows the surgeon to better perform the surgical procedure, thereby increasing the efficacy of the procedure, as recognized by Lang [1491].
Regarding Claim 11, the combination of references teaches the invention substantially as claimed. Johnson fails to explicitly teach the computer program product further including sets of instructions for identifying a current status of the treatment of the bone and for providing information suitable for guidance for a next step in the treatment of the bone.
Lang teaches a system for performing surgery on a head-mounted display (Abstract). This system contains instructions for identifying a current status of the treatment of the bone and for providing information suitable for guidance for a next step in the treatment of the bone [0242].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system the surgical plan, as taught by Lang, because this allows the surgeon to better perform the surgical procedure, thereby increasing the efficacy of the procedure, as recognized by Lang [1491].
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Johnson in view of Blau as applied to claim 1 above, and further in view of Blau’779 and Lang.
Regarding Claim 9, the combination of references teaches the images substantially as claimed. Johnson fails to explicitly teach the computer program product further including sets of instructions for receiving information of a predetermined position and/or orientation of at least one of the first object and the second object.
Blau’779 teaches a system for determining relative positions between objects (Abstract). This system receiving the predetermined position and/or orientation of the first and second object (i.e. the intended spatial relation) [0035].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to receive the intended position, as taught by Blau’779, because it increases the safety and accuracy of procedures to know the relative positions of different objects during a surgery to where they are supposed to be located, as recognized by Blau’779 [0016].
The combination of references fails to explicitly teach to provide a visualization of the information on the augmented-reality device.
Lang teaches a system for performing surgery on a head-mounted display (Abstract). This system displays a visualization of a virtual surgical plan, which includes predetermined positions of objects [1466]-[1467].
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the combined system to display an insertion path, as taught by Lang, because this allows the surgeon to better perform the surgical procedure, thereby increasing the efficacy of the procedure, as recognized by Lang [1491].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fotouhi et al. (Fotouhi, Javad, et al. "Co-localized augmented human and X-ray observers in collaborative surgical ecosystem." International journal of computer assisted radiology and surgery 14.9 (2019): 1553-1563.), which teaches a method for calibrating a C-arm with an AR system.
Siewerdsen et al. (U.S PGPub 2014/0049629 A1), which teaches a tracking system for surgical navigation.
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/SEAN D MATTSON/ Primary Examiner, Art Unit 3798
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