DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments, see pages 11-12, filed 25 June 2026, with respect to 103 rejections have been fully considered and are persuasive in view of amendment. The 112 and 102 rejections of 07 April 2026 have been withdrawn.
Claims 1, 3, 5-11, and 14-22 are rejected under 35 U.S.C. 101 while claim 13 was found to be eligible under §101.
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.
Claim 13 was found to be §101 eligible at step 2A although, elements of a medical imaging system, a camera and a needle and a display are still pre and post insignificant activities, the element of “wherein the intervention control device is configured to control an intervention using the needle based on the augmented camera image data” is limitation that apply judicial exception recited in claim 20 with particular use of a needle and linking the use of judicial exception to a particular technology, such as a needle intervention, such that the claims as a whole is more than a drafting effort designed to monopolize the exception (MPEP 2106.05 (b) (c) and (e)).
Claims 1, 3, 5-11, and 14-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a computer-implemented method for generating augmented camera image data for guiding a needle intervention, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 1 recites the limitations:
determining information concerning a planned insertion pose of a needle based on the medical image data, wherein the information including-includes coordinates assigned to the planned insertion pose of the needle in a medical image data coordinate system a needle insertion point, and a needle orientation for the needle intervention, and wherein the determining the information includes determining an end point of the needle at a start of the insertion, based on a target needle tip position by virtually moving the needle insertion point in an opposite direction of a planned needle direction;
determining coordinates assigned to the planned insertion pose of the needle in a camera coordinate system of the camera by transforming the coordinates assigned to the planned insertion pose of the needle in the medical image data coordinate system into the camera coordinate system; and
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by judgement), a needle insertion point, orientation and end point of the needle can be determined by observing a position and orientation of the needle at insertion point, and tip position and determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations”. A human, such as surgeon and/or physician, could mentally perform tasks of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by opinion), a needle insertion point, orientation and end point of the needle can be determined by observing a position and orientation of the needle at insertion point, and tip position and virtually moving the needle insertion point in an opposite direction of a planned needle direction can be done by imagination or simple drawing of the needle insertion point in opposite direction of a planned needle direction.
When planned pose of the needle coordinate is determined, a surgeon can determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data using mathematical calculation of transformation.
These steps can all be performed in the mind with aid of a pen and paper.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
receiving medical image data of an examination portion of a patient;
receiving camera image data of the examination portion, the camera image data acquired using a camera;
generating augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
This claim elements of receiving image data, camera image data acquired using a camera and generating augmented camera image data are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the interface, computer, and processor itself, just simply gathering medical image data and camera image data which are necessary precursors for all uses of the recited abstract idea since no determination of planned needle insertion point and transformation of the coordinate into camera coordinate can be performed without first gathering necessary image data. In addition, generating augmented camera image data based on the abstract idea is mere outputting the result of transformation of the data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., interface and processor as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 1 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
receiving medical image data of an examination portion of a patient;
receiving camera image data of the examination portion, the camera image data acquired using a camera;
generating augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
The above-identified additional elements of “receiving medical image data and camera image data and generating augmented camera image data” are performed by “interface circuits (as stated in [0116])” and “a computer processing device, CPU, a processor ([0025] and [0118])”, which are all generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a computer processing device as a processor, CPU, a controller, ALU and many others, generically described without structure and further describes “interface” being interface circuits may be wired or wireless interfaces connected to LAN, internet, WAN or combinations thereof and a server (also known as remote or cloud) module ([0116]), which elements are disclosed with high generality leading to a conclusion that these elements are well-known in the field.
With respect to “ camera image acquired by a camera,” specification describes a camera of smartphone ([0070]), which is described as a commercially available product that indicates that the element of camera is sufficiently well-known in the field of generating image data.
Accordingly, in light of applicant’s specification, the claimed term interface circuits and computer/processor are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the interface and computer/processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Therefore, the examiner concludes that receiving medical image data, camera image data acquired by a camera and generating augmented camera image data by interface and computer/processor are common use in medical image guidance, and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 1 is ineligible.
Claims 3, 5-11, and 14-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claims recite s computer implemented method, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claims 3, 5-11, and 14-19 recite the limitations:
Of claim 3, wherein the determining information concerning the planned insertion pose of the needle in the medical image data includes determine at least one of the planned needle direction or a length of the needle.
Of claim 5, wherein the information concerning the planned insertion pose of the needle in the medical image data comprises a planned end point of a head of the needle at an end of the needle intervention.
Of claim 6, wherein the planned end point of the head of the needle at the end of the needle intervention is determined by addition of a target needle tip position to the end point of the needle at the start of the insertion and subtracting a needle insertion point.
Of claim 7, wherein the camera image data includes 2D camera image data, and the determining coordinates assigned to the planned insertion pose of the needle in the camera coordinate system of the camera includes transforming the coordinates assigned to the planned insertion pose from the medical image data coordinate system into a 3D camera coordinate system, and projecting the transformed coordinates into 2D camera image data to determine 2D coordinates assigned to the planned insertion pose.
Of claim 8, wherein the transforming the coordinates assigned to the planned insertion pose from the medical image data coordinate system into a 3D camera coordinate system includes applying a camera transform to the coordinates assigned to the planned insertion pose in the medical image data coordinate system.
Of claim 9, wherein the transforming the coordinates assigned to the planned insertion pose from the medical image data coordinate system into a 3D camera coordinate system includes applying a transformation representing a new table position.
Of claim 10, wherein the camera transform is determined based on an extrinsic calibration step.
Of claim 11, A camera-based method for guiding a needle intervention, the camera-based method comprising: generating augmented camera image data by performing the computer- implemented method according to claim 1; and displaying the augmented camera image data.
Of claim 14, A non-transitory computer program product comprising instructions that, when executed by a computer, cause the computer to perform the computer-implemented method of claim 1.
Of claim 15, A non-transitory computer-readable storage medium comprising instructions that, when executed by a computer, cause the computer to perform the computer-implemented method of claim 1.
Of claim 16, The computer-implemented method according to claim 3, wherein the information concerning the planned insertion pose of the needle in the medical image data comprises a planned end point of a head of the needle
Of claim 17, wherein the planned end point of the head of the needle at the end of the needle intervention is determined by addition of a target needle tip position to the end point of the needle at the start of the insertion and subtracting a needle insertion point.
Of claim 18, wherein the camera image data includes 2D camera image data, and the determining coordinates assigned to the planned insertion pose of the needle in the camera coordinate system of the camera includes transforming the coordinates assigned to the planned insertion pose from the medical image data coordinate system into a 3D camera coordinate system, and projecting the transformed coordinates into 2D camera image data to determine 2D coordinates assigned to the planned insertion pose.
Of claim 19, wherein the transforming the coordinates assigned to the planned insertion pose from the medical image data coordinate system into a 3D camera coordinate system includes applying a transformation representing a new table position.
These underlined limitations, as drafted, are process steps that, under its broadest reasonable interpretation, cover the performance of the limitation in the mind as they recite steps of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by judgement), target needle tip position can be determined by mentally simulating the needle insertion and reaching to a target, and an end point of the needle at a start of the insertion can be determined by observing a position and orientation of the needle at insertion point, its direction and length of the needle can be determined by simply observation, and tip position and converting coordinates using transformation matrix, projecting data points, and determining extrinsic calibration by applying transformation function.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations”. A human, such as surgeon and/or physician, could mentally perform tasks of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by opinion), a needle insertion point, orientation and end point of the needle can be determined by observing a position and orientation of the needle at insertion point, and target tip position can be done by imagination and simulating needle reaching target. Moreover, “a planned end of a head of a needle at an end of the needle intervention determined by addition of a target needle tip position to the end point of the needle at a start of the insertion and subtracting a needle insertion point,” which is mathematical formula describing relationship of points in coordinates.
When planned pose of the needle coordinate is determined, a surgeon can determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data using mathematical calculation of transformation. The calibration by applying transform function and data transformation and projecting data are all mathematical calculations by performing mathematical operation and manipulation of data.
These steps can all be performed in the mind with aid of a pen and paper.
That is, nothing in the claim elements preclude the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
Of claims 7 and 18, wherein the camera image data includes 2D camera image data,
Of claim 11, A camera-based method for guiding a needle intervention, the camera-based method comprising: generating augmented camera image data by performing the computer- implemented method according to claim 1; and displaying the augmented camera image data.
Of claim 14, A non-transitory computer program product comprising instructions that, when executed by a computer, cause the computer to perform the computer-implemented method of claim 1.
Of claim 15, A non-transitory computer-readable storage medium comprising instructions that, when executed by a computer, cause the computer to perform the computer-implemented method of claim 1.
This claim elements of computer program product and computer-readable storage medium performing the abstract ideas , 2D camera image data acquired using a camera and displaying augmented camera image data are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the interface, computer, and display itself, just simply gathering medical image data and camera image data which are necessary precursors for all uses of the recited abstract idea since no determination of planned needle insertion point and transformation of the coordinate into camera coordinate can be performed without first gathering necessary image data. In addition, generating augmented camera image data based on the abstract idea is mere outputting the result of transformation of the data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., interface and processor as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 22 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
Of claims 7 and 18, wherein the camera image data includes 2D camera image data,
Of claim 11, A camera-based method for guiding a needle intervention, the camera-based method comprising: generating augmented camera image data by performing the computer- implemented method according to claim 1; and displaying the augmented camera image data.
Of claim 14, A non-transitory computer program product comprising instructions that, when executed by a computer, cause the computer to perform the computer-implemented method of claim 1.
Of claim 15, A non-transitory computer-readable storage medium comprising instructions that, when executed by a computer, cause the computer to perform the computer-implemented method of claim 1.
The above-identified additional elements of computer-readable product and medium and display, which are all generically claimed computer components of software storable in storage and display which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a computer readable medium and computer program product as a various example of program, instructions storable with non-limiting examples ([0129]), which makes it clear that elements are disclosed with high generality leading to a conclusion that these elements are well-known in the field.
With respect to “ camera image acquired by a camera,” and “display,” specification describes a camera of smartphone ([0070]), and “display of a smartphone ([0070])” which is described as a commercially available product that indicates that the element of camera is sufficiently well-known in the field of generating image data.
Accordingly, in light of applicant’s specification, the claimed term computer program and display are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the claimed elements. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware/software are conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Therefore, the examiner concludes that computer product and computer readable medium as well as display are common use in medical image guidance, and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claims 3, 5-11, and 14-19 are ineligible.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites an intervention control device, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 20 recites the limitations:
determine information concerning a planned insertion pose of a needle based on the medical image data, by determining an end point of the needle at a start of the insertion, based on a target needle tip position, by virtually moving the needle insertion point in an opposite direction of a planned needle direction, the information including coordinates assigned to the planned insertion pose of the needle in a medical image data coordinate system, a needle insertion point, and a needle orientation for the needle intervention,
determine coordinates assigned to the planned insertion pose of the needle in a camera coordinate system of the camera by transforming the coordinates assigned to the planned insertion pose of the needle in the medical image data coordinate system into the camera coordinate system; and
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by judgement), a needle insertion point, orientation and end point of the needle can be determined by observing a position and orientation of the needle at insertion point, and tip position and determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations”. A human, such as surgeon and/or physician, could mentally perform tasks of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by opinion), a needle insertion point, orientation and end point of the needle can be determined by observing a position and orientation of the needle at insertion point and tip position (can be done by observation and determining exact coordinates of each position), and virtually moving the needle insertion point in an opposite direction of a planned needle direction can be done by imagination or simple drawing of the needle insertion point in opposite direction of a planned needle direction.
When planned pose of the needle coordinate is determined, a surgeon can determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data using mathematical calculation of transformation.
These steps can all be performed in the mind with aid of a pen and paper.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
A medical image data interface to receive medical image data of an examination portion of a patient;
A camera image data interface to receive camera image data of the examination portion, and
At least one processor configured to:
generate augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
This claim elements of interface for receiving image data, camera image data and a processor configured to generate augmented camera image data are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the interface and processor itself, just simply gathering medical image data and camera image data which are necessary precursors for all uses of the recited abstract idea since no determination of planned needle insertion point and transformation of the coordinate into camera coordinate can be performed without first gathering necessary image data. In addition, generating augmented camera image data based on the abstract idea is mere outputting the result of transformation of the data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., interface and processor as claimed).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 20 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
A medical image data interface to receive medical image data of an examination portion of a patient;
a camera image interface to receive camera image data of the examination portion,
at least one processor configured to generate augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
The above-identified additional elements of “receiving medical image data and camera image data and generating augmented camera image data” are performed by “interface circuits (as stated in [0116])” and “a computer processing device, CPU, a processor ([0025] and [0118])”, which are all generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a computer processing device as a processor, CPU, a controller, ALU and many others, generically described without structure and further describes “interface” being interface circuits may be wired or wireless interfaces connected to LAN, internet, WAN or combinations thereof and a server (also known as remote or cloud) module ([0116]), which elements are disclosed with high generality leading to a conclusion that these elements are well-known in the field.
With respect to “ camera image acquired by a camera,” specification describes a camera of smartphone ([0070]), which is described as a commercially available product that indicates that the element of camera is sufficiently well-known in the field of generating image data.
Accordingly, in light of applicant’s specification, the claimed term interface circuits and computer/processor are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the interface and computer/processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Therefore, the examiner concludes that receiving medical image data, camera image data acquired by a camera and generating augmented camera image data by interface and computer/processor are common use in medical image guidance, and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 20 is ineligible.
Claim 21 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites a computer-implemented method for generating augmented camera image data for guiding a needle intervention, thus is a method.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 21 recites the limitations:
determining information concerning a planned insertion pose of a needle based on the medical image data, wherein the information including-includes coordinates assigned to the planned insertion pose of the needle in a medical image data coordinate system and a planned end of a head of a needle at an end of the needle intervention determined by addition of a target needle tip position to the end point of the needle at a start of the insertion and subtracting a needle insertion point;
determining coordinates assigned to the planned insertion pose of the needle in a camera coordinate system of the camera by transforming the coordinates assigned to the planned insertion pose of the needle in the medical image data coordinate system into the camera coordinate system;
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by judgement), target needle tip position can be determined by mentally simulating the needle insertion and reaching to a target, and an end point of the needle at a start of the insertion can be determined by observing a position and orientation of the needle at insertion point, and tip position and determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations”. A human, such as surgeon and/or physician, could mentally perform tasks of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by opinion), a needle insertion point, orientation and end point of the needle can be determined by observing a position and orientation of the needle at insertion point, and target tip position can be done by imagination and simulating needle reaching target. Moreover, “a planned end of a head of a needle at an end of the needle intervention determined by addition of a target needle tip position to the end point of the needle at a start of the insertion and subtracting a needle insertion point,” which is mathematical formula describing relationship of points in coordinates.
When planned pose of the needle coordinate is determined, a surgeon can determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data using mathematical calculation of transformation.
These steps can all be performed in the mind with aid of a pen and paper.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
receiving medical image data of an examination portion of a patient;
receiving camera image data of the examination portion, the camera image data acquired using a camera;
generating augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
This claim elements of receiving image data, camera image data acquired using a camera and generating augmented camera image data are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the interface, computer, and processor itself, just simply gathering medical image data and camera image data which are necessary precursors for all uses of the recited abstract idea since no determination of planned needle insertion point and transformation of the coordinate into camera coordinate can be performed without first gathering necessary image data. In addition, generating augmented camera image data based on the abstract idea is mere outputting the result of transformation of the data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., interface and processor as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 21 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
receiving medical image data of an examination portion of a patient;
receiving camera image data of the examination portion, the camera image data acquired using a camera;
generating augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
The above-identified additional elements of “receiving medical image data and camera image data and generating augmented camera image data” are performed by “interface circuits (as stated in [0116])” and “a computer processing device, CPU, a processor ([0025] and [0118])”, which are all generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a computer processing device as a processor, CPU, a controller, ALU and many others, generically described without structure and further describes “interface” being interface circuits may be wired or wireless interfaces connected to LAN, internet, WAN or combinations thereof and a server (also known as remote or cloud) module ([0116]), which elements are disclosed with high generality leading to a conclusion that these elements are well-known in the field.
With respect to “ camera image acquired by a camera,” specification describes a camera of smartphone ([0070]), which is described as a commercially available product that indicates that the element of camera is sufficiently well-known in the field of generating image data.
Accordingly, in light of applicant’s specification, the claimed term interface circuits and computer/processor are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the interface and computer/processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Therefore, the examiner concludes that receiving medical image data, camera image data acquired by a camera and generating augmented camera image data by interface and computer/processor are common use in medical image guidance, and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 21 is ineligible.
Claim 22 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1: Statutory Category: Yes - The claim recites n intervention control device, thus is an apparatus.
Step 2A, Prong 1, Judicial Exception: Yes - The claim 22 recites the limitations:
determine information concerning a planned insertion pose of a needle based on the medical image data, wherein the information including-includes coordinates assigned to the planned insertion pose of the needle in a medical image data coordinate system and a planned end of a head of a needle at an end of the needle intervention determined by addition of a target needle tip position to the end point of the needle at a start of the insertion and subtracting a needle insertion point;
determine coordinates assigned to the planned insertion pose of the needle in a camera coordinate system of the camera by transforming the coordinates assigned to the planned insertion pose of the needle in the medical image data coordinate system into the camera coordinate system;
These limitations, as drafted, is a process step that, under its broadest reasonable interpretation, covers the performance of the limitation in the mind as it recites steps of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by judgement), target needle tip position can be determined by mentally simulating the needle insertion and reaching to a target, and an end point of the needle at a start of the insertion can be determined by observing a position and orientation of the needle at insertion point, and tip position and determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data.
These actions fall under the Mental Processes and Mathematical Concepts categories defined in MPEP 2106.04(A)(2) as “concept performed in the human mind (including observation, evaluation, judgement and opinion)” and “mathematical calculations”. A human, such as surgeon and/or physician, could mentally perform tasks of observing the image and determine information of a planned pose of a needle (desired position can be determined in mind by opinion), a needle insertion point, orientation and end point of the needle can be determined by observing a position and orientation of the needle at insertion point, and target tip position can be done by imagination and simulating needle reaching target. Moreover, “a planned end of a head of a needle at an end of the needle intervention determined by addition of a target needle tip position to the end point of the needle at a start of the insertion and subtracting a needle insertion point,” which is mathematical formula describing relationship of points in coordinates.
When planned pose of the needle coordinate is determined, a surgeon can determine transformed coordinate of the planned insertion pose of the needle into the camera coordinate using transformation matrix conversion of data using mathematical calculation of transformation.
These steps can all be performed in the mind with aid of a pen and paper.
That is, nothing in the claim element precludes the step from practically being performed in the mind and/or being performed with the aid of a pen and paper. Accordingly, the claim recites a mental process-type and mathematical concepts abstract idea.
Step 2A, Prong 2, Integrated into Practical Application: No - The claim recites the following additional elements:
A medical image data interface to receive medical image data of an examination portion of a patient;
A camera image data interface to receive camera image data of the examination portion
At least one processor configured to:
generating augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
This claim elements of receiving image data, camera image data acquired using a camera and generating augmented camera image data are a mere data collection step which amounts to a pre-solution insignificant activity and post-solution activity. The claims do not specify any configuration or improvement in the interface, computer, and processor itself, just simply gathering medical image data and camera image data which are necessary precursors for all uses of the recited abstract idea since no determination of planned needle insertion point and transformation of the coordinate into camera coordinate can be performed without first gathering necessary image data. In addition, generating augmented camera image data based on the abstract idea is mere outputting the result of transformation of the data.
Moreover, the above-identified abstract idea is not integrated into a practical application in accordance with MPEP 2106.04(d) because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process and mathematical calculations) using rules (e.g., computer instructions) executed by a computer (e.g., interface and processor as disclosed in specification).
In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer according to MPEP 2106.05(f). Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims according to MPEP 2106.05(a). That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claim 22 (and their respective dependent claims) is not integrated into a practical application under MPEP 2106.04(d)(I).
Thus, this claim is therefore directed to an abstract idea.
Step 2B, Inventive Concept: No – The claim recites additional claim elements recite the following additional elements:
A medical image data interface to receive medical image data of an examination portion of a patient;
A camera image data interface to receive camera image data of the examination portion
At least one processor configured to:
generating augmented camera image data based on the camera image data and the coordinates assigned to the planned insertion pose of the needle in the camera coordinate system.
The above-identified additional elements of “receiving medical image data and camera image data and generating augmented camera image data” are performed by “interface circuits (as stated in [0116])” and “a computer processing device, CPU, a processor ([0025] and [0118])”, which are all generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, MPEP 2106.05(d)(II) along with Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per applicant’s specification, applicant describes a computer processing device as a processor, CPU, a controller, ALU and many others, generically described without structure and further describes “interface” being interface circuits may be wired or wireless interfaces connected to LAN, internet, WAN or combinations thereof and a server (also known as remote or cloud) module ([0116]), which elements are disclosed with high generality leading to a conclusion that these elements are well-known in the field.
With respect to “ camera image acquired by a camera,” specification describes a camera of smartphone ([0070]), which is described as a commercially available product that indicates that the element of camera is sufficiently well-known in the field of generating image data.
Accordingly, in light of applicant’s specification, the claimed term interface circuits and computer/processor are reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available technology, with their already available basic functions, to use as tools in executing the claimed process. See MPEP 2106.05(f).
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the interface and computer/processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see MPEP 2106.05(d)(I)(2) and 2106.07(a)(III)). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications along with MPEP 2106.05(d)(I)).
Therefore, the examiner concludes that receiving medical image data, camera image data acquired by a camera and generating augmented camera image data by interface and computer/processor are common use in medical image guidance, and thus, simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception is not significantly more when recited with a claim with a judicial exception, fails to amount to significantly more than the judicial exception individually and in combination.
In light of the above, claim 22 is ineligible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICIA J PARK whose telephone number is (571)270-1788. The examiner can normally be reached Monday-Thursday 8 am - 3 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached at 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PATRICIA J PARK/Primary Examiner, Art Unit 3798
Prosecution Insights