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 with respect to claims 1-6 and 8-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 6, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation and further in view of Günther (EP 2358276 B1) and Gadda (US 20210259783).
Regarding Claims 1, 16, and 17, Hartkens discloses a method for supporting medical personnel during a resection ([0001] – “The invention relates to a method for image monitoring of a minimally invasive procedure with an instrument in a patient’s procedure area”, [0002] – “Examples of such minimally invasive procedures are partial resection of the liver or partial nephrectomy”), the method comprising: [claim 1]
a system for supporting medical personnel during a resection ([0019] – “the present invention therefore proposes in this advantageous embodiment to use an integrated system”, [0002] – “Examples of such minimally invasive procedures are partial resection of the liver or partial nephrectomy”), the system comprising: [claim 16]
a data processing facility ([0039] – “an image processing device 1, which is designed to carry out the method according to the invention”) configured to: [claim 16]
a computer program product comprising commands which, during execution of the commands by a computer of a system ([0039] – “an image processing device 1, which is designed to carry out the method according to the invention…the image processing device accesses a memory device 6 and corresponding computing units”), cause the system to:
acquiring a preoperative three-dimensional (3D) data set of an examination object on which the resection is to be carried out ([0006] – “preoperatively recorded three-dimensional computed tomography image data sets”, [0031] – “the minimally invasive procedure was planned using a three-dimensional image data set”);
acquiring, by ultrasound using an ultrasound probe or an ultrasound head, image data of a resection surface to generate an ultrasound data set describing the resection surface ([0033] – “In a step S2, the recording of ultrasound images begins”, [0021] – “it is possible to evaluate changes between consecutively recorded ultrasound images, so that, for example, resections or the like are noticeable”, Fig. 3 – ultrasonic heads (13));
registering the ultrasound data set with the 3D data set ([0033] – “step S3 to produce an initial registration of the ultrasound images with the three-dimensional image data set”, [0035] – “further ultrasound images are recorded during the minimally invasive procedure, the elastic registration determined in step S3 is tracked”); and
updating the 3D data set with the resection surface ([0036] – “This is used in step S5 to modify the three-dimensional image data set in preparation for the display so that it reflects these displacements or elastic deformations of the tissue in the engagement area”); and
iteratively repeating the acquiring, the registering, and the updating (Fig. 1 shows the method steps being iteratively repeated) when a change to the resection surface is detected ([0037] – “In a step S7, it is checked during the intervention whether a trigger event has occurred…a trigger event can arise…for example in the case of a resection of parts of the kidney… trigger events are also monitored automatically”), wherein the iterative repeating comprises:
acquiring updated image data of a changed resection surface to generate an updated ultrasound data set based on a detected change ([0038] – “However, if there is a trigger event…The process then continues with step S1… In a step S2, the recording of ultrasound images begins”);
registering the updated ultrasound data set with the 3D data set using a respective preceding registration as a starting point to provide an updated registration that modifies the preceding registration ([0033] – “In a step S2, the recording of ultrasound images begins, with the first recorded ultrasound images being used in a step S3 to produce an initial registration of the ultrasound images with the three-dimensional image data set”, it is disclosed that when a trigger event arises a new 3D data set is acquired for registration however one with ordinary skill in the art would recognize that by registering the updated ultrasound with the data set using a respective preceding registration a new 3D data set would not be required because there would be less of a change between the updated ultrasound and the respective preceding registration); and
updating the 3D data set with the changed resection surface ([0036] – “step S5 to modify the three-dimensional image data set”).
Conversely Hartkens does not teach registering the ultrasound data set with the 3D data set based on at least one spacing of structures, wherein the at least one spacing of structures comprises a spacing between the ultrasonic probe or the ultrasonic head and one or more structures visible in the ultrasound data set, and wherein each spacing is dependent upon an observation angle of the ultrasonic probe or the ultrasonic head such that the registering is carried out with regard to both position and orientation of the one or more structures in the ultrasound data set, and wherein each structure of the one or more structures is weighted based on a positioning of the respective structure to the resection surface or to a region of a respective current change to the resection surface;
However Günther discloses registering the ultrasound data set with the 3D data set based on at least one spacing of structures, wherein the at least one spacing of structures comprises a spacing between the ultrasonic probe or the ultrasonic head and one or more structures visible in the ultrasound data set, and wherein each spacing is dependent upon an observation angle of the ultrasonic probe or the ultrasonic head such that the registering is carried out with regard to both position and orientation of the one or more structures in the ultrasound data set ([0097] – “all ultrasound data can be transformed to this coordinate system by the transform unit 300 and thereby are in registration with the 3D reference model”, [0018] – “The position detection system detects the position and/or orientation of each of the one or more ultrasound transducers. From ultrasound data provided by the ultrasound unit and from position and/or orientation information provided by the position detection system the processing unit calculates physiologic data, position, orientation and/or geometry of the object of interest”, the position and orientation of the object of interest in the ultrasound data would provide a spacing between the ultrasonic transducer and the object of interest);
Günther is an analogous art considering it is in the field of registration of 3Dmodel and an ultrasound image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hartkens to incorporate the registration using a spacing of structures of Günther to achieve the same results. One would have motivation to combine because it allows one to maximize a similarity measure between the 3D model and the ultrasound image while compensating for induced movements.
Conversely Hartkens and Günther do not teach wherein each structure of the one or more structures is weighted based on a positioning of the respective structure to the resection surface or to a region of a respective current change to the resection surface;
However Gadda discloses wherein each structure of the one or more structures is weighted based on a positioning of the respective structure to the resection surface or to a region of a respective current change to the resection surface ([0071] – “the point weighting scheme for the match is determined based on proximity of the match to a target anatomic location. For example, a weight of a match is determined based on a distance between the match and the target anatomic location. In that example, a match associated with a model point closer to the target anatomic location may have a greater weight”, the resection surface of Hartkens can be considered a target anatomical location).
Gadda is an analogous art considering it is in the field of image registration between an image and a 3D model/image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the weighting of structures based on proximity for registration of Gadda to achieve the same results. One would have motivation to combine because it will “provide improved registration for performing image-guided procedures” (Gadda [0004]).
Regarding Claim 2, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Hartkens further discloses wherein the image data of the resection surface is acquired continuously by ultrasound during the resection and the ultrasound data set is continuously updated accordingly ([0013] – “deform the preoperative three-dimensional image data set depending on the intraoperative ultrasound image information, in real time…the live ultrasound images”).
Regarding Claim 6, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Hartkens discloses an elastic registration based on features visible in the ultrasound data ([0009] - "an elastic registration between at least one first-recorded ultrasound image and the image data set is determined based on at least one feature visible in the ultrasound image").
Conversely Harkens does not teach wherein structures positioned closer to the resection surface or to the region of the respective current change to the resection surface are more strongly weighted as compared with structures positioned further removed from the resection surface or the region of the respective current change to the resection surface.
However Gadda discloses wherein structures positioned closer to the resection surface or to the region of the respective current change to the resection surface are more strongly weighted as compared with structures positioned further removed from the resection surface or the region of the respective current change to the resection surface ([0071] – “the point weighting scheme for the match is determined based on proximity of the match to a target anatomic location. For example, a weight of a match is determined based on a distance between the match and the target anatomic location. In that example, a match associated with a model point closer to the target anatomic location may have a greater weight”, the resection surface of Hartkens can be considered a target anatomical location).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the weighting of structures based on proximity for registration of Gadda to achieve the same results. One would have motivation to combine because it will “provide improved registration for performing image-guided procedures” (Gadda [0004]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), and Gadda (US 20210259783) as applied to claim 1 above, and further in view of Rucker (US 20140037161).
Regarding Claim 3, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hartkens does not teach acquiring, immediately before the start of the resection, acquisition data of the examination object by an imaging modality, wherein the acquisition data describes a then current posture of the examination object; and
registering, in a context of an initial registration, the acquisition data with the preoperative 3D data set.
However, Rucker discloses acquiring, immediately before the start of the resection, acquisition data of the examination object by an imaging modality, wherein the acquisition data describes a then current posture of the examination object ([0059] – “alternate registration methods for an initial pose can also be used. For this example, the patient data (cloud 202) was acquired using a laser range scanner which is currently part of the PTI guidance system versus a computer model 204 of a patient organ. Alternate methods of capturing organ geometry could be possible (e.g. stereo-pair, swabbing with tracked stylus, etc.)”; and
registering, in a context of an initial registration, the acquisition data with the preoperative 3D data set ([0059] – “patient-to-image registration result using a salient feature weighting. However, the various embodiments are not limited in this regard and alternate registration methods for an initial pose can also be used”).
Rucker is an analogous art considering it is in the field of image registration of a pre-acquired image and an ultrasound image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the acquisition data of Rucker to achieve the same results. One would have motivation to combine because it would provide a more accurate 3D model for subsequent registrations.
Claims 4 and 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), and Gadda (US 20210259783) as applied to claim 1 above, and further in view of Fan (US 20140369584).
Regarding claim 4, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hartkens does not teach wherein the resection surface or a change of the resection surface is determined by automatic detection of an air gap on the resection surface.
However Fan discloses wherein the resection surface or a change of the resection surface is determined by automatic detection of an air gap on the resection surface ([0102] – “the resection cavity…ultrasound may be used to provide a better estimation of the shape of cavity”, a cavity would cause an air gap).
Fan is an analogous art considering it is in the field of image guided resection.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the detection of a cavity/air gap of Fan to achieve the same results. One would have motivation to combine because it provides “revised tumor and structure locations, and these locations are displayed to the surgeon to assist in any additional resections” (Fan – [0089]).
Regarding claim 9, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Hartkens further discloses tracking a position of an instrument provided for carrying out the resection and/or an operating state of the instrument, wherein the operating state comprises: (1) a switching state or actuation level of an operating element, (2) a measure or a strength of an energy supply to the instrument, (3) a rotary speed of the instrument, (4) a load of a motor or drive of the instrument, or (5) a combination thereof, ([0030] – “An ultrasound recording device is used to obtain current intraoperative information about the position of the instrument used, for example a needle”), and
Conversely Hartkens does not teach wherein a change of the resection surface in the 3D data set for updating thereof is only entered when, at a point in time of a detected change, the instrument was in contact with the examination object and/or the operating state of the instrument was consistent with the change of the resection surface.
However Fan discloses wherein a change of the resection surface in the 3D data set for updating thereof is only entered when, at a point in time of a detected change, the instrument was in contact with the examination object and/or the operating state of the instrument was consistent with the change of the resection surface (Abstract – “the model of deformation is adapted or constrained to model locations and dimensions of surgical cavities using an optical flow method and/or locations of surgical instruments in the organ”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the updating of the model based on the tool location in contact with the examination object of Fan to achieve the same results. One would have motivation to combine because it provides “revised tumor and structure locations, and these locations are displayed to the surgeon to assist in any additional resections” (Fan – [0089]).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), and Gadda (US 20210259783) as applied to claim 1 above, and further in view of Brannan (US 20180008341).
Regarding claim 5, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Hartkens further discloses wherein the differentiation is used as a boundary condition in the registration of the ultrasound data set with the 3D data set ([0035] – “The current registration therefore contains in particular the information which elastic transformations describe the displacements of the tissue compared to the three-dimensional image data set”, therefore the registration is performed based on the displacements/differentiation between the 3D image and the intraoperative image).
Conversely Hartkens does not teach wherein the image data of the resection surface is acquired by Doppler ultrasound based on corresponding Doppler ultrasound data, wherein intact and separated parts of the examination object are differentiated from one another.
However Brannan discloses wherein the image data of the resection surface is acquired by Doppler ultrasound based on corresponding Doppler ultrasound data, wherein intact and separated parts of the examination object are differentiated from one another (Abstract – “generating a representation of the active heating zone relative to the surgical site based on the detected Doppler shift”, [0023] – “As it is used in this description, “ablation procedure” generally refers to any tissue ablation procedure, such as, for example, microwave ablation, radiofrequency (RF) ablation, or microwave or RF ablation-assisted resection), [0005] – “the Doppler shift associated with the active heating zone is unique to the active heating zone and may be distinguished from a Doppler shift associated with other physiological features such as blood flow”).
Brannan is an analogous art considering it is in the field of resection.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the Doppler ultrasound of Brannan to achieve the same results. One would have motivation to combine because it provides data to help one distinguish one area from another.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), and Gadda (US 20210259783), as applied to claim 1 above, and further in view of Boctor (US 20150031990).
Regarding claim 8, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
As cited above Hartkens discloses registration of the ultrasound data set with the 3D data set, conversely Hartkens does not teach providing a planning data set describing a preoperative planning for a spatial course of the resection; and
using the planning data set as a boundary condition for plausibility checking of the registration of the ultrasound data set with the […preoperative] data set and/or the updating of the […preoperative] data set.
However Boctor discloses providing a planning data set describing a preoperative planning for a spatial course of the resection ([0053] – “Preoperative CT would be used to plan the surgical resection… the surgeon will place several small fiducial markers within the planned resection volume”); and
using the planning data set as a boundary condition for plausibility checking of the registration of the ultrasound data set with the […preoperative] data set and/or the updating of the […preoperative] data set ([0053] – “The tracked markers can be used to maintain registration to the registered preoperative information”).
Boctor is an analogous art considering it is in the field of image registration for a resection procedure.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the planning data of Boctor to achieve the same results. One would have motivation to combine because it provides data that allows one to see if/when the resection is completed.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), and Gadda (US 20210259783) as applied to claim 1 above, and further in view of Ghose (US 20210042878).
Regarding claim 10, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hartkens does not teach acquiring, after the resection, a second ultrasound data set by moving an ultrasonic probe along the resection surface in direct mechanical contact with the ultrasonic probe;
registering the second ultrasound data set with the 3D data set of the examination object; and
checking a course of the resection surface based on the registered second ultrasound data set and the updated 3D data set.
However Ghose discloses acquiring, after the resection, a second ultrasound data set by moving an ultrasonic probe along the resection surface in direct mechanical contact with the ultrasonic probe ([0048] – “post-operative ultrasound images 220 (acquired at step 222 after resection) to account for non-linear deformation of the brain tissue due to resection”);
registering the second ultrasound data set with the 3D data set of the examination object ([0048] – “a registration model based on brain structure (or other suitable anatomic structure) is applied (step 210) between intra-operative ultrasound images 190 (i.e., before resection) and post-operative ultrasound images 220 (acquired at step 222 after resection) to account for non-linear deformation of the brain tissue due to resection. This results in a second nonlinear transformation (Tr2) 212 that can be applied (step 230) to the iMRI”); and
checking a course of the resection surface based on the registered second ultrasound data set and the updated 3D data set ([0048] – “generate or update a transformed iMRI 232 account for non-linear deformation of the brain tissue due to resection, which may be useful in evaluating the surgical outcome, such as to determine whether a surgical operation has been completed or additional resection is needed”).
Ghose is an analogous art considering it is in the field of image guided resection.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the repeated registration of Ghose to achieve the same results. One would have motivation to combine because it will “allow continuous guidance, better visualization of the soft tissue and the tumor, and reduces surgery time” (Ghose – [0044]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), Gadda (US 20210259783), and Ghose (US 20210042878) as applied to claim 10 above, and further in view of Kadoury (US 20140193053).
Regarding claim 11, Hartkens, Günther, Gadda, and Ghose disclose all the elements of the claimed invention as cited in claims 1 and 10.
As cited above in claim 10 Ghose discloses the ultrasonic probe being guided along the resection surface
Conversely Hartkens does not teach tracking one position or posture of the ultrasonic probe while the ultrasonic probe is guided […].
However Kadoury discloses tracking one position or posture of the ultrasonic probe while the ultrasonic probe is guided […] ([0035] – “concurrently obtains corresponding position information from a sensor 123”, [0036] – “The probe 122 includes the sensor or sensors 123”).
Kadoury is an analogous art considering it is in the field of image registration of a pre-acquired image and an ultrasound image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the tracking of a position of the ultrasound probe of Kadoury to achieve the same results. One would have motivation to combine because it would provide more detail of the position of features in the ultrasound image for registration.
Claims 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), Gadda (US 20210259783), Ghose (US 20210042878), and Kadoury (US 20140193053) as applied to claims 10 and 11 above, and further in view of Boctor (US 20150031990).
Regarding claims 12 and 14, Hartkens, Günther, Gadda, Ghose, and Kadoury disclose all the elements of the claimed invention as cited in claims 1, 10, and 11.
Conversely Hartkens does not teach wherein, for the checking, a spacing of the resection surface from a region to be resected according to a preoperative planning is determined and evaluated according to a defined criterion and, where present, regions of the resection surface for which the criterion is not met are automatically marked in the second ultrasound data set and/or in the 3D data set.
However Ghose teaches regions of the resection surface for which the criterion is not met are automatically marked in the second ultrasound data set and/or in the 3D data set ([0010] – “Guidance is provided based on the post-operation transformed MR image regarding whether the surgical operation has been completed”, it is obvious to one with ordinary skill in the art that the guidance could include visual guidance).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the marking of Ghose to achieve the same results. One would have motivation to combine because it will “allow continuous guidance, better visualization of the soft tissue and the tumor, and reduces surgery time” (Ghose – [0044]).
Conversely Hartkens and Ghose does not teach wherein, for the checking, a spacing of the resection surface from a region to be resected according to a preoperative planning is determined and evaluated according to a defined criterion and, where present, regions of the resection surface for which the criterion is not met are automatically marked,
However Boctor discloses wherein, for the checking, a spacing of the resection surface from a region to be resected according to a preoperative planning is determined and evaluated according to a defined criterion and, where present, regions of the resection surface for which the criterion is not met are automatically marked ([0053] – “After resection, PA imaging may be used to detect any markers left behind, thus indicating possible inadequate margins.”),
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the planning data of Boctor to achieve the same results. One would have motivation to combine because it provides data that allows one to see if/when the resection is completed and where further resection may be needed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), Gadda (US 20210259783), and Ghose (US 20210042878) as applied to claim 10 above, and further in view of Piron (US 20170358083).
Regarding claim 15, Hartkens, Günther, Gadda, and Ghose disclose all the elements of the claimed invention as cited in claim 1 and 10.
Conversely Hartkens does not teach wherein, after the resection, a surface of a respective resected part is additionally acquired and a corresponding resected part data set describing the resected part is taken into account during the checking.
However Piron discloses wherein, after the resection, a surface of a respective resected part is additionally acquired and a corresponding resected part data set describing the resected part is taken into account during the checking ([0047] – “computing device 200 is configured to obtain a second image of the resected tissue sample”, [0050] – “following the acquisition of second image 500, computing device 200 is configured at block 330 to determine, based on a comparison of first image 400 and second image 500, whether the entire target region identified at block 315 is represented in second image 500”).
Piron is an analogous art considering it is in the field of tissue resection.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the resected part data set of Piron to achieve the same results. One would have motivation to combine because it provides automatic indication of the entire target being fully resected or not fully resected.
Claims 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), and Gadda (US 20210259783) as applied to claim 1 above, and further in view of Thompson (US 20180158201).
Regarding claim 18, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hartkens does not teach wherein the one or more structures visible in the ultrasound data set are positioned within the predetermined distance from the resection surface.
However Thompson discloses wherein the one or more structures visible in the ultrasound data set are positioned within the predetermined distance from the resection surface ([0033] – “Described herein is a locally rigid registration…during a laparoscopic procedure, such as laparoscopic resection of the liver”, Abstract – “use the multiple 2-D ultrasound images to identify 3-D vessel locations in the deformable organ; determine a rigid registration between the 3-D vessel graph from the 3-D pre-operative image data and the identified 3-D vessel locations in the deformable organ”, one with ordinary skill in the art would recognize a structure such as a vessel would be positioned within a predetermined distance from the resection surface).
Thompson is an analogous art considering it is in the field of image registration between a ultrasound and a 3D image.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the one or more structures being positioned within a predetermined distance from the resection surface of Thompson to achieve the same results. One would have motivation to combine because the location of a vessel on an organ will be the same for the ultrasound image and the 3D image therefore it provides a good landmark for image registration.
Regarding claim 19, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hartkens does not teach wherein the one or more structures comprise a vessel, a vessel branch, or an edge of a tissue region of a tumor or an organ.
However Thompson discloses wherein the one or more structures comprise a vessel, a vessel branch, or an edge of a tissue region of a tumor or an organ (Abstract – “use the multiple 2-D ultrasound images to identify 3-D vessel locations in the deformable organ; determine a rigid registration between the 3-D vessel graph from the 3-D pre-operative image data and the identified 3-D vessel locations in the deformable organ”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the one or more structures being a vessel of Thompson to achieve the same results. One would have motivation to combine because the location of a vessel on an organ will be the same for the ultrasound image and the 3D image therefore it provides a good landmark for image registration.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Hartkens (DE 102014212089) machine translation, Günther (EP 2358276 B1), and Gadda (US 20210259783) as applied to claim 1 above, and further in view of Xu (US 20190005645).
Regarding claim 20, Hartkens, Günther, and Gadda disclose all the elements of the claimed invention as cited in claim 1.
Conversely Hartkens does not teach wherein the ultrasonic probe or the ultrasonic head is in direct mechanical contact with the resection surface during the acquiring of the image data of the resection surface.
However Xu discloses wherein the ultrasonic probe or the ultrasonic head is in direct mechanical contact with the resection surface during the acquiring of the image data of the resection surface ([0074] discloses use of a IOUS probe to image the liver before and after resection, [0003] – “the IOUS probe can be placed in contact with the anterior, superior, inferior or posterior liver surface”).
Xu is an analogous art considering it is in the field of image registration for a resection procedure.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Hartkens to incorporate the probe being in direct contact with the resection surface of Xu to achieve the same results. One would have motivation to combine because “IOUS has several advantages, including: IOUS does not suffer from the acoustic attenuation caused by the abdominal wall and thus may utilize a higher frequency to obtain a higher spatial resolution” (Xu – [0003]).
Allowable Subject Matter
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./ Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797