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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitations are: “an image providing unit”, “an intervention path providing unit”, “a structure at risk providing unit”, “a position providing unit”, “an evaluation unit”, “an output unit”, “a control unit” in claim 1, “a visualization unit” in claim 3.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The image providing unit may be an imaging device ([0012]). The position providing unit is a tracking system ([0014]). The structure at risk unit is a trained neural network ([0072]). The visualization unit comprises a graphical user interface ([0094]). The remaining limitations are do not have sufficient structure in the specification to perform the claimed structure
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 1, the claim limitations “intervention path providing unit”, “evaluation unit”, “output unit”, and “control unit” do not have sufficient support in the specification to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(a) are also rejected because they inherit the enablement requirement of the claims they respectively depend upon.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 and 15-18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the claim limitations “intervention path providing unit”, “an evaluation unit”, “an output unit”, and “control unit” render the claim unclear, as the limitations do not have sufficient support in the specification to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof, and therefore has failed to particularly point out and distinctly claim the invention.
Regarding claim 15 recites “a location of a structure at risk”. However, it is unclear if this is the same or different “a location of a structure at risk” than the one recited in claim 10. For examination purposes, it shall be considered the same.
Regarding claim 16 recites “a tracked position of the medical instrument.”. However, it is unclear if this is the same or different “a tracked position of the medical instrument” than the one recited in claim 10. For examination purposes, it shall be considered the same.
Regarding claim 17 recites “an initial image of a target location inside a patient's body”. However, it is unclear if this is the same or different “an initial image of a target location inside a patient's body” than the one recited in claim 10. For examination purposes, it shall be considered the same.
Regarding claim 18 recites “a control image”. However, it is unclear if this is the same or different “a control image” than the one recited in claim 10. For examination purposes, it shall be considered the same.
Claims that are not discussed above but are cited to be rejected under 35 U.S.C. 112(b) are also rejected because they inherit the indefiniteness of the claims they respectively depend upon.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 9, 10, 12-20 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandroni et al., (US20210085268A1) in view of Thienphrapa et al., (US20200275982A1) and Braido et al., (US20230157757A1).
Regarding claim 1, Alexandroni teaches a system for assistance in a surgical procedure, the system comprising (fig. 1A navigation and image system 100 [0034]);
an image providing unit configured for providing an initial image of a target location inside a patient's body ([0037] target is on either the fluoroscopy image or CT image),
an intervention path providing unit configured for providing in the initial image an intervention path along which a medical instrument shall be guided to the target location ([0037] a pathway is determined to the target on the fluoroscopy and/or CT images),
a unit configured for providing in the initial image a location of a structure at risk ([0049]-[0050] user may mark one or more features that the biopsy needle must avoid),
a position providing unit configured for providing a tracked position of the medical instrument ([0038] tracking system 50 tracks the biopsy tool),
an evaluation unit configured for evaluating whether a spatial relation between a) the tracked position and b) the location of the structure at risk and/or the intervention path meets a predefined criterion ([0072] the method determines if the direction of the needle is consistent with the trajectory of the path),
an output unit configured for providing an output signal indicative of whether the spatial relation meets the predefined criterion ([0073] if the direction of the needle is consistent with the planned trajectory, advancement of the needle is displayed, if not the needle is adjusted).
However, Alexandroni is silent regarding a control unit configured for controlling the image providing unit to provide a control image of the target location if the output signal indicates that the evaluated spatial relation meets the criterion.
In the same interventional imaging field of endeavor, Thienphrapa teaches a control unit configured for controlling the image providing unit to provide a control image of the target location if the output signal indicates that the evaluated spatial relation meets the criterion ([0013] upon detection that the controller navigated proximal to the critical anatomical location, interventional imaging within the anatomical region of the patient is performed to generate an updated anatomical roadmap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging of Alexandroni with the imaging method of Thienthrapa, as this would facilitate a reduction in radiation exposure in an interventional setting (see Thienthrapa [0004]).
However, the combination of references fail to explicitly disclose a structure at risk providing unit.
In the same medical imaging field of endeavor, Braido a structure at risk providing unit ([0122] CNN is used for tool tracking and procedure techniques).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Alexandroni to incorporate a machine learning model such as Braido that identifies structures to avoid, as this would allow for more successful outcomes to procedures (see Braido [0008]).
Regarding claim 2, modified Alexandroni teaches the system of claim 1, but is silent regarding wherein the control unit is configured for defining a control area at which the criterion is met and for controlling the imaging providing unit to provide a control image when the medical instrument reaches the control area.
In the same interventional imaging field of endeavor, Thienphrapa teaches wherein the control unit is configured for defining a control area at which the criterion is met and for controlling the imaging providing unit to provide a control image when the medical instrument reaches the control area ([0060] robot control 90 determines if the location is at or within a defined vector form the critical anatomical location; [0068] if the robot control ascertains the control is proximate to a critical anatomical location, the robot control proceeds to acquire a new x-ray image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging of Alexandroni with the imaging method of Thienthrapa, as this would facilitate a reduction in radiation exposure in an interventional setting (see Thienthrapa [0004]).
Regarding claim 3, modified Alexandroni teaches the system of claim 2, wherein Alexandroni further teaches a visualization unit (fig. 1A computing device comprises a display [0034]) configured for visualizing the tracked position and the control area are in the initial image ([0085] 3D position of the location sensor 28 of the instrument and the target may be displayed, which would include the control area), said control area indicating a position of the medical instrument at which the control image has been or will be provided ([0037] the initial images comprise the target, and also comprise the position of which the biopsy tool would end up).
Regarding claim 4, modified Alexandroni teaches the system of claim 3, wherein Alexandroni further teaches wherein the visualization unit (fig. 1A computing device 125 includes a video display [0034]) is further configured for visualization the intervention path and where the control area lies on intervention path (fig. 3 shows a display with trajectory 320 and the target 312, which is where the control area lies [0057]).
Regarding claim 6, modified Alexandroni teaches the system of claim 1, wherein Alexandroni further teaches wherein the evaluation unit is configured for evaluating that the spatial relation between a) the tracked position and b) the intervention path meets the criterion if a deviation of the tracked position from the intervention path exceeds a threshold deviation value indicative of an allowed deviation of the tracked position from the intervention path ([0072] the method determines if the advancement of the needle is consistent with the planned trajectory or if it is not consistent. This means there is a threshold deviate value).
Regarding claim 9, modified Alexandroni teaches the system of modified claim 1, but fails to explicitly disclose wherein the structure at risk providing unit comprises a neural network that is trained for receiving the initial image as input and for providing as output a location of the structure at risk in the initial image.
In the same medical imaging field of endeavor, Braido teaches wherein the structure at risk providing unit comprises a neural network ([0122] CNN is used for tool tracking and procedure techniques) that is trained for receiving the initial image as input and for providing as output a location of the structure at risk in the initial image ([0049] machine learning is used for image classification for auto segmentation and identification of structures to avoid based on previous data).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Alexandroni to incorporate a machine learning model such as Braido that identifies structures to avoid, as this would allow for more successful outcomes to procedures (see Braido [0008]).
Regarding claim 10, Alexandroni teaches a method for assistance in a surgical procedure, the system comprising (fig. 1A navigation and image system 100 [0034]);
receiving an initial image of a target location inside a patient's body ([0037] target is on either the fluoroscopy image or CT image),
providing in the initial image an intervention path along which a medical instrument shall be guided to the target location ([0037] a pathway is determined to the target on the fluoroscopy and/or CT images),
receiving in the initial image a location of a structure at risk ([0049]-[0050] user may mark one or more features that the biopsy needle must avoid),
receiving a tracked position of the medical instrument ([0038] tracking system 50 tracks the biopsy tool),
evaluating whether a spatial relation between the tracked position and the location of the structure at risk and/or the intervention path meets a criterion ([0072] the method determines if the direction of the needle is consistent with the trajectory of the path),
providing an output signal indicative of whether the spatial relation meets the predefined criterion ([0073] if the direction of the needle is consistent with the planned trajectory, advancement of the needle is displayed, if not the needle is adjusted).
However, Alexandroni is silent regarding providing a control image of the target location if the output signal indicates that the evaluated spatial relation meets the criterion.
In the same interventional imaging field of endeavor, Thienphrapa teaches a control unit configured for controlling the image providing unit to provide a control image of the target location if the output signal indicates that the evaluated spatial relation meets the criterion ([0013] upon detection that the controller navigated proximal to the critical anatomical location, interventional imaging within the anatomical region of the patient is performed to generate an updated anatomical roadmap).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging of Alexandroni with the imaging method of Thienthrapa, as this would facilitate a reduction in radiation exposure in an interventional setting (see Thienthrapa [0004]).
Regarding claim 12, modified Alexandroni teaches the method of claim 10, wherein Alexandroni further teaches a non-transitory computer readable medium storing the computer program that when executed by a computer causes the computer to perform the method of claim 10 ([0096] computer readable medium that stores the desired program code).
Regarding claim 13, modified Alexandroni teaches the method of claim 10, wherein Alexandroni further teaches wherein the system a) comprises a computer (fig. 1a computing device 125 [0034]).
Regarding claim 14, modified Alexandroni teaches the system of claim 1, but is silent regarding wherein the criterion is a predefined criterion.
In the same interventional imaging field of endeavor, Thienphrapa teaches wherein the criterion is a predefined criterion ([0020]“the term “critical anatomical location” encompasses a location within an anatomical roadmap defined by an intervention system of the present disclosure as a location within an anatomical roadmap that necessitates a generation of an updated anatomical roadmap for purposes of facilitating a navigation of an interventional robot within the patient anatomy.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging of Alexandroni with the imaging method of Thienthrapa, as this would facilitate a reduction in radiation exposure in an interventional setting (see Thienthrapa [0004]).
Regarding claim 15, modified Alexandroni teaches the method of claim 10, wherein Alexandroni further teaches providing in the initial image a location of a structure at risk ([0049]-[0050] user may mark one or more features that the biopsy needle must avoid).
Regarding claim 16, modified Alexandroni teaches the method of claim 10, wherein Alexandroni further teaches providing a tracked position of the medical instrument ([0038] tracking system 50 tracks the biopsy tool).
Regarding claim 17, modified Alexandroni teaches the method of claim 10 wherein Alexandroni further teaches an initial image of a target location inside a patient's body ([0037] target is on either the fluoroscopy image or CT image),
Regarding claim 18, modified Alexandroni teaches the method of claim 10, but is silent regarding defining a control area at which the criterion is met and for providing a control image when the medical instrument reaches the control area.
In the same interventional imaging field of endeavor, Thienphrapa teaches defining a control area at which the criterion is met and for providing a control image when the medical instrument reaches the control area ([0060] robot control 90 determines if the location is at or within a defined vector form the critical anatomical location; [0068] if the robot control ascertains the control is proximate to a critical anatomical location, the robot control proceeds to acquire a new x-ray image).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the imaging of Alexandroni with the imaging method of Thienthrapa, as this would facilitate a reduction in radiation exposure in an interventional setting (see Thienthrapa [0004]).
Regarding claim 19, modified Alexandroni teaches the system of claim 10, wherein Alexandroni further teaches visualizing the tracked position and a control area are in the initial image ([0085] 3D position of the location sensor 28 of the instrument and the target may be displayed, which would include the control area), the control area indicating a position of the medical instrument at which the control image has been or will be provided ([0037] the initial images comprise the target, and also comprise the position of which the biopsy tool would end up).
Regarding claim 20, modified Alexandroni teaches the system of claim 3, wherein Alexandroni further teaches wherein visualizing the intervention path, wherein the control area lies on intervention path (fig. 3 shows a display with trajectory 320 and the target 312, which is where the control area lies [0057]).
Claims 5 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandroni in view of Thienphrapa and Braido as applied to claim 1 and 10 above, and further in view of Shochat (US20170071672A1)
Regarding claim 5, modified Alexandroni teaches the system of claim 1, wherein Alexandroni teaches i) the evaluation unit is configured for evaluating the a) the tracked position ([0038] the tracking system 50 tracks the position of the biopsy tool 27) and b) the location of the structure at risk ([0030] structures to avoid are marked on the images) but fails to explicitly disclose wherein the structure at risk providing unit is configured for defining a safety distance with respect to the structure at risk.
In the same image-guided interventional procedure field of endeavor, Shochat teaches and wherein i) the evaluation unit is configured for evaluating that the spatial relation between a) the track and b) the location of the structure at risk meets the criterion if the tracked position of the medical instrument is closer to the structure at risk than the defined safety distance ([0064] the program determines if the distance between the calculated trajectory and a marked obstacle is less than a minimal acceptable distance.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to apply the technique of considering the distance between structure at risk and the trajectory as taught by Shochat to the tracked position of the based device tool of modified Alexandroni, as both inventions relate image guided interventional procedures, and would yield the predictable result of a evaluating the distance between the tracked position and the obstacles to one of ordinary skill in the art. One of ordinary skill would be able to apply such a technique, and the results of modified Alexandroni tracking the distance from the obstacle are reasonably predictable. One of ordinary skill would understand that this modification of modified Alexandroni and Shochat would then result in the reading of the limitation wherein i) the evaluation unit is configured for evaluating that the spatial relation between a) the tracked position and b) the location of the structure at risk meets the criterion if the tracked position of the medical instrument is closer to the structure at risk than the defined safety distance.
Claims 7 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Alexandroni in view of Thienphrapa and Braido as applied to claim 1 above, and further in view of Schneider (US6073043).
Regarding claim 7, modified Alexandroni teaches the system of claim 1, but fails to explicitly disclose wherein the evaluation unit is configured for evaluating if a reliability value associated with the tracked position is below a threshold reliability value for the tracked position and the output unit is further configured for providing a warning signal if the reliability value is below the threshold reliability value.
In the same medical imaging field of endeavor, Schneider teaches wherein the evaluation unit is configured for evaluating if a reliability value associated with the tracked position is below a threshold reliability value for the tracked position and the output unit is further configured for providing a warning signal if the reliability value is below the threshold reliability value (col. 17 line 61 - col. 18 line there is a norm in the position and orientation, and a threshold hold can be set by which the tracking quality can be monitored. When the norm exceeds (such as going above or below) then a warning is given).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Alexandroni with the norm index of Schneider, as this would improve the accuracy of the positioning and orientation solution (see Abstract Scheider).
Regarding claim 21, modified Alexandroni teaches the method of claim 10, but fails to explicitly disclose evaluating if a reliability value associated with the tracked position is below a threshold reliability value for the tracked position and providing a warning signal if the reliability value is below the threshold reliability value.
In the same medical imaging field of endeavor, Schneider teaches evaluating if a reliability value associated with the tracked position is below a threshold reliability value for the tracked position and providing a warning signal if the reliability value is below the threshold reliability value. (col. 17 line 61 - col. 18 line there is a norm in the position and orientation, and a threshold hold can be set by which the tracking quality can be monitored. When the norm exceeds (such as going above or below) then a warning is given).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Alexandroni with the norm index of Schneider, as this would improve the accuracy of the positioning and orientation solution (see Abstract Scheider).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Alexandroni in view of Thienphrapa and Braido as applied to claim 1 above, and further in view of Viswanathan (US20060094956A1.)
Regarding claim 8, modified Alexandroni teaches the system of claim 1, wherein Alexandroni further teaches, wherein the evaluation unit is configured for evaluating that the spatial relation between the tracked position and the intervention path meets the predefined criterion ([0072] the method determines if the direction of the needle is consistent with the trajectory of the path) but is silent regarding if the tracked position is closer to the target location than a threshold target distance to the target location.
In the same surgical imaging field of endeavor, Viswanathan teaches if the tracked position is closer to the target location than a threshold target distance to the target location ([0035]the sensed position is not within a predetermined distance of the at least one predetermined target location).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to modify the system of modified Alexandroni with the threshold of Visanathan, as this would help prevent the medical device form straying from the intended target or being navigated to locations where it might cause complications (see Viswanathan [0002]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL Y FANG whose telephone number is (571)272-0952. The examiner can normally be reached Mon - Friday 9:30 am - 6:00pm.
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/MICHAEL YIMING FANG/ Examiner, Art Unit 3798
/PASCAL M BUI PHO/ Supervisory Patent Examiner, Art Unit 3798
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