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 the 35 USC § 112(b) rejections of claims 2-21 have been considered but not issues were addressed therefore the claims remain rejected under 35 USC § 112(b).
Applicant’s arguments with respect to the prior art rejections of claims 2-21 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-21 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 2, line 14 of claim 2 recites “pathway from the location of the catheter to the target”. However, the location of the catheter has not been previously defined therefore there is insufficient antecedent basis for this limitation in the claim. Fore examination purposes this limitation will be read as “pathway from a location of the catheter to the target”. Claims 3-8 are also rejected due to their dependency.
Regarding claim 3, line 3 of claim 3 recites “detect via the sensor a location of the catheter within the luminal network”. However, a location of the catheter has been defined in claim 2 therefore it is unclear if this is the same location or a different location of the catheter. For examination purposes the claim will be interpreted as “detect via the sensor the location of the catheter within the luminal network”. Claims 4-8 are also rejected due to their dependency.
Regarding claim 9, lines 8-9 of claim 9 recites “the pathway from the location of the tool to the target”. However, the location of the tool has not been previously defined therefore there is insufficient antecedent basis for this limitation in the claim. Fore examination purposes this limitation will be read as “pathway from a location of the tool to the target”. Claims 10-18 are also rejected due to their dependency.
Regarding claim 10, line 2 of claim 10 recites “detecting via a sensor of the tool a location of the tool within the luminal network”. However, a location of the tool has been defined in claim 9 therefore it is unclear if this is the same location or a different location of the tool. For examination purposes the claim will be interpreted as “detecting via a sensor of the location of the tool within the luminal network”. Claims 11-18 are also rejected due to their dependency.
Regarding claim 19, lines 9-10 of claim 19 recites “the pathway from the location of the tool to the target”. However, the location of the tool has not been previously defined therefore there is insufficient antecedent basis for this limitation in the claim. For examination purposes this limitation will be read as “pathway from a location of the tool to the target”. Claims 20-21 are also rejected due to their dependency.
Regarding claim 20, line 3 of claim 20 recites “detect a location of the tool within the luminal network”. However a location of the tool has been defined in claim 19 therefore it is unclear if this is the same location or a different location of the tool. For examination purposes the claim will be interpreted as “detecting the location of the tool within the luminal network”. Claim 21 is also rejected due to their dependency.
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 2-21 are rejected under 35 U.S.C. 103 as being unpatentable over Panescu (US 20140343416) and further in view of Oh (US 20160174945).
Regarding claims 2 and 9, Panescu discloses a system for endoluminal navigation ([0002] – “systems and methods for tracking a medical device within a patient anatomy during a medical procedure”, [0046] – “The information from the tracking system 135 may be sent to the navigation system 142”, as seen in the display in Fig. 2A the system is a system for endoluminal navigation), comprising: [claim 2]
a method of navigational plan generation ([0002] – “systems and methods for tracking a medical device within a patient anatomy during a medical procedure”, [0046] – “The information from the tracking system 135 may be sent to the navigation system 142”, [0046] – “navigation system 142…to provide the clinician or other operator with real-time position information on the display system 111 for use in the control of the instrument 120”) comprising: [claim 9]
a catheter including a sensor ([0036] – “instrument 120 can function as a catheter”, [0037] – “a position sensor system 136…for determining the position, orientation, speed, pose, and/or shape of the distal end 128 and optionally one or more segments 137 (regions) along the instrument 120”); and [claim 2]
a computing device including a memory, a processor, and a display, the computing device in communication with the sensor and the memory storing therein instructions that when executed by the processor ([0091] – “the invention may be implemented in software to execute on a processor of a computer system such as control system 116”, [0027] discloses the details of the control system 116 including the processor affecting control of the display, and a memory, the control system including software instructions to implement the methods disclosed, [0037] – “The tracking system 135 may be implemented as hardware, firmware, software or a combination thereof which interact with or are otherwise executed by one or more computer processors, which may include the processors of a control system 116”) cause the computing device to: [claim 2]
receive intra-procedural cone beam computed tomography (CBCT) image data of at least a portion of a luminal network and a distal portion of the catheter located in the luminal network ([0053] – “external imaging system 150…cone-beam CT scanner…can be used to provide an intraoperative image (e.g., 2D, 3D, static view, live view, 360° view, wedge view, or any other type of view) of anatomy A and/or instrument 104”);
determine a location of a target in the CBCT image data ([0053] – “external imaging system 150…cone-beam CT scanner”, [0083] – “FEATURE EXTRACTION step 330A in which features of interest for the procedure (e.g., anatomical structures, surgical targets, instruments, fiducials, etc.) are identified within the external image data”);
determine in the CBCT image data a pathway from the distal portion of the catheter to the target in the CBCT image data (Abstract – “taking intraoperative external image data of a patient anatomy, and using that image data to generate a modeling adjustment”, [0053] – “external imaging system 150…cone-beam CT scanner”, [0086] – “by registering the anatomical model of an internal patient anatomical structure (e.g., airway tree) with an external reference fiducial(s), guidance can be provided, or potential issues can be identified, with respect to instrument sizing, procedure path, or any other aspect that could be affected by the (e.g., to provide guidance as to instrument sizing, procedure path planning optimization”);
generate a 3D model from the CBCT image data, the 3D model including the target, a representation of at least the distal portion of the catheter, and the pathway from the location of the catheter to the target ([0063] – “intraoperatively generated external image data E (e.g., via segmentation, feature extraction, or any other processing technique) could be used in conjunction with shape sensor data from instrument 104 to generate accurate 3D models or representations of anatomy A and/or instrument 104”, [0053] – “external imaging system 150…cone-beam CT scanner”, image C in Fig. 2A as well as Figs. 2B-2D show the model which includes the target and a representation of at least the distal portion of the catheter, [0050] – “navigational overview of anatomy A (e.g., image C), indicating the pre-planned and/or actual trajectory of instrument 104 in patient P”);
determine intra-operative reference data defining a difference in location of the target in the CBCT image data and pre-procedural image data ([0058] – “FIG. 2D shows external image data E generated by imaging system 150 (e.g., by the scanning operation described with respect to FIG. 2C) for at least a portion of anatomy A overlaid onto an existing model M of anatomy A for comparative purposes. Note that existing model M can be the original (pre-operative) model”, [0059] – “both anatomy-model state and instrument-sensor pose disparities are depicted in FIG. 2D”); and
Conversely Panescu does not teach generate a predictive model of movement of organs and structures of the luminal network incorporating the intra-operative reference data to update the 3D model; and
present the updated 3D model in the display.
However Oh discloses generate a predictive model of movement of organs and structures of the luminal network incorporating the intra-operative reference data to update the 3D model (Fig. 12, [0128] – “A model generator may generate a patient adaptive object model by using a statistical object model and a second image data of a target patient”, [0124] – “the statistical object model, in which the respiratory effect is applied to other organs other than the liver, may be built and stored”, one with ordinary skill in the art would find it obvious to apply the intraoperative reference data shown in Fig. 2D of Panescu as the second image data in Oh to generate the patient adaptive object model showing the respiratory effect as it would provide the comparative details with the respiratory motion); and
present the updated 3D model in the display ([0166] – “The first medical imaging apparatus displays the image by fusing the transformed second image and the first image (operation 419)”).
Oh is an analogous art considering it is in the field of imaging the lungs.
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 system and method of Panescu to incorporate the predictive model of movement to update the 3D model of Oh to achieve the same results. One would have motivation to combine because it will “effectively and precisely correct a certain movement of the patient when performing image registration” (Oh [0007]).
Regarding claims 3 and 10, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 2 and 9.
Panescu further discloses wherein the instructions further cause the computing device to: detect via the sensor a location of the catheter within the luminal network ([0037] – “a position sensor system 136…for determining the position, orientation, speed, pose, and/or shape of the distal end 128 and optionally one or more segments 137 (regions) along the instrument 120…The tracking system 135 may…interact with or are otherwise executed by one or more computer processors, which may include the processors of a control system 116”, as cited above the instrument may be a catheter and Figs. 2A-2F show the position of the instrument within a luminal network).
Regarding claims 4 and 11, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 2, 3, 9 and 10.
Panescu further discloses wherein the sensor is an electromagnetic (EM) sensor ([0037] – “A tracking system 135 can include a position sensor system 136 (e.g., an electromagnetic (EM) sensor system)…sensor system for determining the position, orientation, speed, pose, and/or shape of the distal end 128…along the instrument 120”, [0038] – “EM sensor system that includes one or more conductive coils that may be subjected to an externally generated electromagnetic field. Each coil then produces an induced electrical signal having characteristics that depend on the position and orientation of the coil relative to the externally generated electromagnetic field”, therefore there would be a coil located in the instrument [claim 11]).
Regarding claims 5 and 12, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 2, 3, 9 and 10.
Panescu further discloses wherein the instructions further cause the computing device to: register the updated 3D model to the luminal network of a patient ([0086] – “step 330 can include an optional MODEL-PATIENT REGISTRATION step 330B in which the anatomical model of the patient anatomy is registered more closely to the actual patient anatomy…registering the anatomical model of an internal patient anatomical structure (e.g., airway tree)”).
Regarding claims 6 and 13, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 2, 3, 9 and 10.
Panescu further discloses further comprising a tool selected from the group consisting of an ultrasound tool, an ablation tool, an optical instrument, and a biopsy tool ([0035] – “The instrument 120 can also include an image capture element 134… image capture element 134 can include any type of imaging system, such as a confocal microscope, OCT system, and ultrasonic probe”, [0034] – “flexible body 124 can define one or more working lumens 120A through which surgical instruments (such as optional end effector 132) can be deployed”, [0033] – “end effectors such as shown in the embodiment of FIG. 1B, have a pair or plurality of working members such as…biopsy tools…Examples of electrically activated or enabled end effectors include electrosurgical electrodes, ablation elements”, [0036] – “instrument 120 can function as a catheter”).
Regarding claims 7 and 15, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 2, 3, 9 and 10.
Panescu further discloses wherein the instructions further cause the computing device to: detect advancement of the catheter within the luminal network ([0037] – “A tracking system 135 can include a position sensor system 136 (e.g., an electromagnetic (EM) sensor system) and/or a shape sensor system 138 a sensor system for determining the position, orientation, speed, pose, and/or shape of the distal end 128”); and update the location of the representation of at least the distal portion of the catheter in the 3D model ([0046] – “The information from the tracking system 135 may be sent to the navigation system 142 where it is combined with information from the visualization system 110 and/or the preoperatively taken images and/or the intraoperatively taken images to provide the clinician or other operator with real-time position information on the display system 111”, [0063] – “intraoperatively generated external image data E (e.g., via segmentation, feature extraction, or any other processing technique) could be used in conjunction with shape sensor data from instrument 104 to generate accurate 3D models or representations of anatomy A and/or instrument 104”).
Regarding claims 8 and 16, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 2, 3, 9, and 10.
As cited above Panescu discloses generation of a 3D model including a representation of at least the distal portion of the tool/catheter and therefore discloses generation of a 3D model during advancement of the tool/catheter.
Conversely Panescu does not teach wherein the instructions further cause the computing device to: access the predictive model of movement of organs and structures of the luminal network during a respiratory cycle; and continually update the 3D model based on the predictive model […].
However Oh discloses wherein the instructions further cause the computing device to: access a predictive model of movement of organs and structures of the luminal network during a respiratory cycle; and continually update the 3D model based on the predictive model […] (Fig. 12 shows a statistical model over time being combined with second image data to generate a patient adaptive model, [0121] – “a statistical object model indicating the transformation of object caused by the respiration…The statistical object model may be stored in the storage unit in advance”, [0047] – “the second image may be a 3D image”, [0120] – “The object may include a variety of organs, such as…the lungs”, [0163] – “The first image may be acquired in real time, and the transformation caused by a periodic movement, such as a respiration, and a heartbeat, may be displayed on the first 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 system and method of Panescu to incorporate the predictive model of movement to update the 3D model of Oh to achieve the same results. One would have motivation to combine because it will “effectively and precisely correct a certain movement of the patient when performing image registration” (Oh [0007]).
Regarding claim 14, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 9 and 10.
Panescu further discloses wherein the luminal network is airways of a patient’s lungs (Figs. 2A-2F show that the luminal network is airways of a patient’s lungs, [0086] – “registering the anatomical model of an internal patient anatomical structure (e.g., airway tree) with an external reference fiducial(s)”).
Regarding claim 17, Panescu and Oh discloses all the elements of the claimed invention as cited in claims 9, 10, and 16.
Conversely Panescu does not teach wherein the predictive model is of relative movement of a patient’s lungs during a respiratory cycle.
However Oh discloses wherein the predictive model is of relative movement of a patient’slungs during a respiratory cycle (Fig. 12 shows a statistical model over time being combined with second image data to generate a patient adaptive model, [0121] – “a statistical object model indicating the transformation of object caused by the respiration”, [0120] – “The object may include a variety of organs, such as…the lungs”).
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 system and method of Panescu to incorporate the predictive model of movement of the lungs of Oh to achieve the same results. One would have motivation to combine because it will “effectively and precisely correct a certain movement of the patient when performing image registration” (Oh [0007]).
Regarding claim 18, Panescu and Oh discloses all the elements of the claimed invention as cited in claims 9, 10, and 16.
As cited above Panescu discloses generation of a 3D model from the CBCT image data.
Conversely Panescu does not teach wherein the […] image data is acquired during a tidal breathing of a respiratory cycle.
However Oh discloses wherein the […] image data is acquired during a tidal breathing of a respiratory cycle ([0119] – “the first image is acquired in real time, a patient may be in easy respiration”, therefore it would be obvious to acquire the CBCT image data of Panescu during tidal breathing/easy respiration so that the predictive model more closely matches the movement of the patient while the CBCT image was taken).
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 system and method of Panescu to incorporate the images acquired during tidal breathing of Oh to achieve the same results. One would have motivation to combine because it would allow the patient to be relaxed during the procedure.
Regarding claim 19, Panescu discloses a non-transitory computer-readable storage medium storing instructions which, when executed by a computer ([0027] – “The control system 116 also includes software programming instructions to implement some or all of the methods described herein. In various embodiments, such software programming instructions can be stored on non-transitory computer readable media 116C”), cause the computer to:
receive intra-procedural cone beam computed tomography (CBCT) image data of at least a portion of a luminal network and a distal portion of a tool located in the luminal network ([0053] – “external imaging system 150…cone-beam CT scanner…can be used to provide an intraoperative image (e.g., 2D, 3D, static view, live view, 360° view, wedge view, or any other type of view) of anatomy A and/or instrument 104”);
determine a location of a target in the CBCT image data ([0053] – “external imaging system 150…cone-beam CT scanner”, [0083] – “FEATURE EXTRACTION step 330A in which features of interest for the procedure (e.g., anatomical structures, surgical targets, instruments, fiducials, etc.) are identified within the external image data”);
determine in the CBCT image data a pathway from the distal portion of the catheter to the target in the CBCT image data (Abstract – “taking intraoperative external image data of a patient anatomy, and using that image data to generate a modeling adjustment”, [0053] – “external imaging system 150…cone-beam CT scanner”, [0086] – “by registering the anatomical model of an internal patient anatomical structure (e.g., airway tree) with an external reference fiducial(s), guidance can be provided, or potential issues can be identified, with respect to instrument sizing, procedure path, or any other aspect that could be affected by the (e.g., to provide guidance as to instrument sizing, procedure path planning optimization”);
generate a 3D model from the CBCT image data, the 3D model including the target, a representation of at least the distal portion of the tool, and the pathway from the location of the tool to the target ([0063] – “intraoperatively generated external image data E (e.g., via segmentation, feature extraction, or any other processing technique) could be used in conjunction with shape sensor data from instrument 104 to generate accurate 3D models or representations of anatomy A and/or instrument 104”, [0053] – “external imaging system 150…cone-beam CT scanner”, image C in Fig. 2A as well as Figs. 2B-2D show the model which includes the target and a representation of at least the distal portion of the instrument, [0050] – “navigational overview of anatomy A (e.g., image C), indicating the pre-planned and/or actual trajectory of instrument 104 in patient P”);
determine intra-operative reference data defining a difference in location of the target in the CBCT image data and pre-procedural image data ([0058] – “FIG. 2D shows external image data E generated by imaging system 150 (e.g., by the scanning operation described with respect to FIG. 2C) for at least a portion of anatomy A overlaid onto an existing model M of anatomy A for comparative purposes. Note that existing model M can be the original (pre-operative) model”, [0059] – “both anatomy-model state and instrument-sensor pose disparities are depicted in FIG. 2D”); and
generate an updated 3D model with data from a pre-procedural 3D model, the 3D model from the CBCT image data (Para [0051] - "Note that while image C is depicted as a frontal view (i.e., frontal plane of anatomy A) for exemplary purposes, in various other embodiments, image C can be a…3D view", Fig.2A shows a luminal network model shown in image C therefore the model can be a 3D model, Para [0057] - " the intraoperative external image data from imaging system 150 can be used in conjunction with an existing model of anatomy A (e.g., a preoperatively generated CT model, optionally modified intraoperatively) to provide a more accurate representation of the immediate intraoperative environment", Para [0006] - "external imaging system…cone-beam CT scanner…provides an intraoperative image of the anatomy"); and
Conversely Panescu does not teach generate a predictive model of movement of organs and structures of the luminal network incorporating the intra-operative reference data to update the 3D model; and
generate an updated 3D model with data from […] the 3D model from the […] image data, and the predictive model;
present the updated 3D model in the display.
However Oh discloses generate a predictive model of movement of organs and structures of the luminal network incorporating the intra-operative reference data to update the 3D model (Fig. 12, [0128] – “A model generator may generate a patient adaptive object model by using a statistical object model and a second image data of a target patient”, [0124] – “the statistical object model, in which the respiratory effect is applied to other organs other than the liver, may be built and stored”, one with ordinary skill in the art would find it obvious to apply the intraoperative reference data shown in Fig. 2D of Panescu as the second image data in Oh to generate the patient adaptive object model showing the respiratory effect as it would provide the comparative details with the respiratory motion);
generate an updated 3D model with data from […] the 3D model from the […] image data, and the predictive model ([0128] – “A model generator may generate a patient adaptive object model by using a statistical object model and a second image data of a target patient”); and
present the updated 3D model in the display ([0166] – “The first medical imaging apparatus displays the image by fusing the transformed second image and the first image (operation 419)”).
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 system and method of Panescu to incorporate the predictive model of movement to update the 3D model of Oh to achieve the same results. One would have motivation to combine because it will “effectively and precisely correct a certain movement of the patient when performing image registration” (Oh [0007]).
Regarding claim 20, Panescu and Oh disclose all the elements of the claimed invention as cited in claim 19.
Panescu further discloses wherein the instructions when executed by the computer further cause the computer to: detect a location of the tool within the luminal network ([0037] – “a position sensor system 136…for determining the position, orientation, speed, pose, and/or shape of the distal end 128 and optionally one or more segments 137 (regions) along the instrument 120…The tracking system 135 may…interact with or are otherwise executed by one or more computer processors, which may include the processors of a control system 116”, Figs. 2A-2F show the position of the instrument within a luminal network).
Regarding claim 21, Panescu and Oh disclose all the elements of the claimed invention as cited in claims 19 and 20.
Panescu further discloses wherein the instructions further cause the computer to: detect advancement of the tool within the luminal network ([0037] – “A tracking system 135 can include a position sensor system 136 (e.g., an electromagnetic (EM) sensor system) and/or a shape sensor system 138 a sensor system for determining the position, orientation, speed, pose, and/or shape of the distal end 128”); and update the location of the representation of at least the distal portion of the tool in the 3D model ([0046] – “The information from the tracking system 135 may be sent to the navigation system 142 where it is combined with information from the visualization system 110 and/or the preoperatively taken images and/or the intraoperatively taken images to provide the clinician or other operator with real-time position information on the display system 111”, [0063] – “intraoperatively generated external image data E (e.g., via segmentation, feature extraction, or any other processing technique) could be used in conjunction with shape sensor data from instrument 104 to generate accurate 3D models or representations of anatomy A and/or instrument 104”).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
/JOSEPH M SANTOS RODRIGUEZ/Primary Examiner, Art Unit 3797
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