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 .
Note: all citations with respect to the specification of present application are citing the paragraph numbers in the Pre-Grant Publication US 2024/0382268 A1.
Election/Restrictions
Applicant’s election without traverse of Invention I (claim 1 – 4, 6, 7, 10, 15 – 19, 21, 22, 27, 29, 31, 32 and 35 – 50) in the reply filed on 05/26/2026 is acknowledged.
Claim 1 – 4, 6, 7, 10, 15 – 19, 21, 22, 27, 29, 31, 32 and 35 – 51 remain pending in the application.
Claim 51 is withdrawn from consideration.
Claim Objections
Claim 31, 36 – 42, 46 and 50 are objected to because of the following informalities:
Claim 31 line 2, limitation "wherein said assessing deformations further comprises" should read "wherein said Deformation module further comprising instructions for".
Claim 36 line 1 – 2, limitation "further comprising incorporating data" should read "wherein said computer memory storage medium further comprises instructions for incorporating data".
Claim 37 line 1 – 2, limitation "further comprising assessing said deformations" should read "wherein said computer memory storage medium further comprises instructions for assessing said deformations".
Claim 38 line 1 – 2, limitation "further comprising updating said steering plan" should read "wherein said computer memory storage medium further comprises instructions for updating said steering plan".
Claim 39 line 1 – 2, limitation "further comprising updating said digital endoluminal map" should read "wherein said computer memory storage medium further comprises instructions for updating said digital endoluminal map".
Claim 40 line 1 – 2, limitation "further comprising assessing stress levels" should read "wherein said computer memory storage medium further comprises instructions for assessing stress levels".
Claim 41 line 1 – 2, limitation "wherein said actuate said steerable elongated body of said endoluminal device comprises" should read "wherein said High-level module further comprises instructions to".
Claim 42 line 1 – 2, limitation "wherein said assessing deformations further comprises assessing" should read "wherein said instructions for assessing deformations further comprises assessing".
Claim 46 line 2, limitation "said deformations of said to one or more lumens" should read "said deformations of said one or more lumens".
Claim 50 line 1 – 2, limitation "a steerable elongated body" should read "said steerable elongated body".
Appropriate correction is required.
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.
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 limitation(s) is/are:
Limitation “Navigational module” in claim 17 and 21.
Limitation “Deformation module” in claim 17 and 27.
Limitation “High-level module” in claim 17, 18 and 22.
Limitation “Stress module” in claim 17, 18 and 29.
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.
Regarding limitation “Navigational module” in claim 17 and 21, the corresponding structural disclosure in the specification of present application is recited as: “a computer memory storage medium, comprising one or more modules” in [0022]; “the endoluminal device 102 is connected to a computer 104 configured to monitor and control actions performed by the endoluminal system 100, including, in some embodiments, self-steering actions of the endoluminal device 102” in [0059]; thus the above limitation is interpreted as instructions, programs executed by a computer, processor or any reasonable equivalent to perform the claimed functions.
Regarding limitation “Deformation module” in claim 17 and 27, the corresponding structural disclosure in the specification of present application is recited as: “a computer memory storage medium, comprising one or more modules” in [0022]; “the endoluminal device 102 is connected to a computer 104 configured to monitor and control actions performed by the endoluminal system 100, including, in some embodiments, self-steering actions of the endoluminal device 102” in [0059]; thus the above limitation is interpreted as instructions, programs executed by a computer, processor or any reasonable equivalent to perform the claimed functions.
Regarding limitation “High-level module” in claim 17, 18 and 22, the corresponding structural disclosure in the specification of present application is recited as: “a computer memory storage medium, comprising one or more modules” in [0022]; “the endoluminal device 102 is connected to a computer 104 configured to monitor and control actions performed by the endoluminal system 100, including, in some embodiments, self-steering actions of the endoluminal device 102” in [0059]; thus the above limitation is interpreted as instructions, programs executed by a computer, processor or any reasonable equivalent to perform the claimed functions.
Regarding limitation “Stress module” in claim 17, 18 and 29, the corresponding structural disclosure in the specification of present application is recited as: “a computer memory storage medium, comprising one or more modules” in [0022]; “the endoluminal device 102 is connected to a computer 104 configured to monitor and control actions performed by the endoluminal system 100, including, in some embodiments, self-steering actions of the endoluminal device 102” in [0059]; thus the above limitation is interpreted as instructions, programs executed by a computer, processor or any reasonable equivalent to perform the claimed functions.
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 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.
Claim 1 – 4, 6, 7, 10, 15 – 19, 21, 22, 27, 29, 31, 32 and 35 – 50 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.
Claim 1 recites limitation “deformations to one or more lumens” in line 8, it is unclear the above one or more lumens are newly introduced different lumens or same one or more lumens as recited in line 3.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as the same one or more lumens as recited in line 3.
Claim 10 recites the limitation "wherein assessing stress levels comprises" in line 8. There is insufficient antecedent basis for this limitation in the claim. The step of assessing stress levels is introduced in claim 4, however claim 10 is dependent on claim 1 not claim 4.
Claim 16 recites limitation “deformations to one or more lumens” in line 10, it is unclear the above one or more lumens are newly introduced different lumens or same one or more lumens as recited in line 4 – 5.
Thus, the above limitation renders claim indefinite. For the purpose of examination, the above limitation is interpreted as the same one or more lumens as recited in line 4 – 5.
Therefore, claim 1, 10, 16 and all corresponding dependent claims are rejected under 35 U.S.C. 112(b), as being indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1, 2, 6, 7, 15 – 19, 22, 27, 29, 31, 32 and 35 – 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kopel et al. (US 2020/0179060 A1; published on 06/11/2020) (hereinafter "Kopel").
Regarding claim 1, Kopel discloses a method of generating a steering plan for a self-steering endoluminal system ("The disclosure is directed to devices, systems, methods, and computer-readable media for registering a 3D bronchial tree model (hereinafter referred to as a “3D model”) with a patient's airways based on electromagnetic navigation." [0026]), comprising:
a. selecting a location accessible through one or more lumens in a digital endoluminal map to which a self-steering endoluminal device needs to reach ("… a treatment plan and the identification of targets within the CT image data set to which a catheter is to be navigated within the patient can be identified ..." [0081]); said digital endoluminal map based on a preoperative volumetric image ("… a pre-operative CT image data set is acquired of the patient at step 802 … At step 804 a 3D model of the airways is generated from the pre-operative CT image data set." [0081]);
b. generating navigational actions for said endoluminal device to reach said location ("… and pathways to these targets are established as part of the treatment plan …" [0081]; "Once the 3D model is generated, the 3D model and treatment plan may be loaded at step 806, into computing device 80 for use by application 81 in conjunction with EMN system 100." [0082]);
c. assessing deformations to one or more lumens from said one or more lumens in said digital endoluminal map ("Based on a deformation model, sensor data 620 may receive a high registration score, and therefore may be considered a best estimate of the position of the location sensor of the bronchoscope. 3D model 700 may be adjusted based on the deformation model." [0080]; "In the case of a lung survey, a catheter 96 including a sensor 94, 95 can be inserted into the airways and driven to collect data regarding the shape of the airways in each of the lobes of the lungs." [0082]);
d. updating said digital endoluminal map according to said deformations ("3D model 700 may be adjusted based on the deformation model." [0080]; "The data acquired from the survey of the lung by the sensor 94 can be used by the application 81 to generate a 3D model of the airways of the patient at step 810. This 3D model of the airways of the patient may be quite different from the 3D model generated from the pre-operative CT image data." [0083]);
e. updating said steering plan according to a result of said updating said digital endoluminal map while said self-steering endoluminal system is reaching said location ("3D model 700 may be adjusted based on the deformation model." [0080]; "Typically, the point cloud generated from the survey will be used by the application 81 to register the 3D model generated from the pre-operative CT image data to the physiology of the patient. In this way, the catheter 96 can be navigated through the airways of the patient without the need of a catheter-based imaging system ..." [0084]).
Regarding claim 2, Kopel discloses all claim limitations, as applied in claim 1, and further discloses performing said navigational actions until reaching said location ("At step 314, the transformed 3D model is registered to the patient using the point cloud data collected and navigation of the patient's airways to an identified target can commence." [0088]).
Regarding claim 6, Kopel discloses all claim limitations, as applied in claim 1, and further discloses providing said plan to said self-steering endoluminal system ("Once the 3D model is generated, the 3D model and treatment plan may be loaded at step 806, into computing device 80 for use by application 81 in conjunction with EMN system 100." [0082]).
Regarding claim 7, Kopel discloses all claim limitations, as applied in claim 1, and further discloses generating said digital endoluminal map comprising said one or more lumens based on an image ("… a pre-operative CT image data set is acquired of the patient at step 802 … At step 804 a 3D model of the airways is generated from the pre-operative CT image data set." [0081]); and
wherein said image is one or more of a CT scan ("… a pre-operative CT image data set is acquired of the patient at step 802." [0081]).
Regarding claim 15, Kopel discloses all claim limitations, as applied in claim 1, and further discloses wherein said assessing deformations further comprises assessing deformation caused by breathing, heartbeats and other causes external to the self-steering endoluminal system ("Due to the flexibility of the lungs, the actual shape of the lungs during the time of a surgical procedure can be deformed or different from the shape at the time of the CT scan and/or initial registration, resulting in the reduction of navigation accuracy ... whereas during the surgical procedure, both registration and navigation, the patient is sedated and breathing normally; (2) the patient may be horizontal for a much longer period during the surgical procedure thereby causing increased deformation; (3) during the surgical procedure, while the bronchoscope is inside of the patient, the head, neck, and superior part of the chest may also be deformed" [0030]).
Regarding claim 16, Kopel discloses a self-steering endoluminal system ("The disclosure is directed to devices, systems, methods, and computer-readable media for registering a 3D bronchial tree model (hereinafter referred to as a “3D model”) with a patient's airways based on electromagnetic navigation." [0026]), comprising:
a. an endoluminal device comprising a self-steerable elongated body ("Bronchoscope 50 is configured for insertion through the patient's mouth and/or nose into the patient's airways. … and which can be manipulated by rotation and compression to steer catheter 96 ..." [0057]);
b. a computer memory storage medium, comprising instructions ("… and a memory storing instructions." [0013]) for:
i. receiving a selection of a location accessible through one or more lumens in a digital endoluminal map to which a self-steering endoluminal device needs to reach ("… a treatment plan and the identification of targets within the CT image data set to which a catheter is to be navigated within the patient can be identified ..." [0081]); said digital endoluminal map based on a preoperative volumetric image ("… a pre-operative CT image data set is acquired of the patient at step 802 … At step 804 a 3D model of the airways is generated from the pre-operative CT image data set." [0081]):
ii. generating navigational actions for said endoluminal device to reach said location ("… and pathways to these targets are established as part of the treatment plan …" [0081]; "Once the 3D model is generated, the 3D model and treatment plan may be loaded at step 806, into computing device 80 for use by application 81 in conjunction with EMN system 100." [0082]);
iii. assessing deformations to one or more lumens from said one or more lumens in said digital endoluminal map ("Based on a deformation model, sensor data 620 may receive a high registration score, and therefore may be considered a best estimate of the position of the location sensor of the bronchoscope. 3D model 700 may be adjusted based on the deformation model." [0080]; "In the case of a lung survey, a catheter 96 including a sensor 94, 95 can be inserted into the airways and driven to collect data regarding the shape of the airways in each of the lobes of the lungs." [0082]):
iv. updating said digital endoluminal map according to said deformations ("3D model 700 may be adjusted based on the deformation model." [0080]; "The data acquired from the survey of the lung by the sensor 94 can be used by the application 81 to generate a 3D model of the airways of the patient at step 810. This 3D model of the airways of the patient may be quite different from the 3D model generated from the pre-operative CT image data." [0083]);
v. updating a steering plan according to a result of said updating said digital endoluminal map while said self-steering endoluminal system is reaching said location ("3D model 700 may be adjusted based on the deformation model." [0080]; "Typically, the point cloud generated from the survey will be used by the application 81 to register the 3D model generated from the pre-operative CT image data to the physiology of the patient. In this way, the catheter 96 can be navigated through the airways of the patient without the need of a catheter-based imaging system ..." [0084]).
Regarding claim 17, Kopel discloses all claim limitations, as applied in claim 16, and further discloses wherein said computer memory storage medium comprises one or more of:
a. a Navigational module ("An electromagnetic navigation (EMN) system may be used for planning and performing treatment of an area of a patient's lungs." [0055]; "Memory 202 may include any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 204 ..." [0070]) comprising instructions for generating navigational actions to be performed by said steerable elongated body of said endoluminal device to reach a desired location as selected in a digital endoluminal map ("… and pathways to these targets are established as part of the treatment plan …" [0081]; "Once the 3D model is generated, the 3D model and treatment plan may be loaded at step 806, into computing device 80 for use by application 81 in conjunction with EMN system 100." [0082]);
b. a Deformation module ("Memory 202 may include any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 204 ..." [0070]) comprising instructions for assessing deformations to one or more lumens ("Based on a deformation model, sensor data 620 may receive a high registration score, and therefore may be considered a best estimate of the position of the location sensor of the bronchoscope. 3D model 700 may be adjusted based on the deformation model." [0080]; "In the case of a lung survey, a catheter 96 including a sensor 94, 95 can be inserted into the airways and driven to collect data regarding the shape of the airways in each of the lobes of the lungs." [0082]);
c. a High-level module ("Memory 202 may include any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 204 ..." [0070]) comprising instructions to receive information from one or more of said Navigational module and said Deformation module and actuate said steerable elongated body of said endoluminal device accordingly ("3D model 700 may be adjusted based on the deformation model." [0080]; "Once the 3D model is generated, the 3D model and treatment plan may be loaded at step 806, into computing device 80 for use by application 81 in conjunction with EMN system 100." [0082]);
d. a Stress module ("Memory 202 may include any non-transitory computer-readable storage media for storing data and/or software that is executable by processor 204 ..." [0070]) comprising instructions for assessing stress levels on said lumens caused by said steerable elongated body of said endoluminal device ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]; here the compression and bending is equivalent to stress in mechanics modeling).
Regarding claim 18, Kopel discloses all claim limitations, as applied in claim 17, and further discloses wherein said High-level module further comprises instructions to receive information from said Stress module and actuate said steerable elongated body of said endoluminal device accordingly ("3D model 700 may be adjusted based on the deformation model." [0080]; "Typically, the point cloud generated from the survey will be used by the application 81 to register the 3D model generated from the pre-operative CT image data to the physiology of the patient. In this way, the catheter 96 can be navigated through the airways of the patient without the need of a catheter-based imaging system ..." [0084]; here the 3D model is updated according to the deformation model including stress information).
Regarding claim 19, Kopel discloses all claim limitations, as applied in claim 16, and further discloses wherein said endoluminal device comprises one or more sensors and at least one external transmitter for monitoring a location of said endoluminal device during said navigational actions ("During a procedure, EM sensors 94, 95, in conjunction with tracking system 70, enables tracking of EM sensors 94, 95 (and thus distal tip 93 of catheter 96 or tools 62, 64) as catheter 96 is advanced through the patient's airways …" [0067]).
Regarding claim 22, Kopel discloses all claim limitations, as applied in claim 17, and further discloses wherein said High-level module further comprises instructions to perform one or more of:
a. generating a steering plan based on said received information ("3D model 700 may be adjusted based on the deformation model." [0080]; "Once the 3D model is generated, the 3D model and treatment plan may be loaded at step 806, into computing device 80 for use by application 81 in conjunction with EMN system 100." [0082]);
b. generating said digital endoluminal map comprising said one or more of lumens based on an image (“At step 804 a 3D model of the airways is generated from the pre-operative CT image data set.” [0081]); wherein said image is one or more of a CT scan ("… a pre-operative CT image data set is acquired of the patient at step 802." [0081]).
Regarding claim 27, Kopel discloses all claim limitations, as applied in claim 16, and further discloses wherein said Deformation module further comprises instructions to perform one or more of:
a. running a second simulation of said deformations ("The deformation model may further include modeling at least one of rotation, compression, extension, and bending for the first region and the second region independently. The deformation model may also include modeling at least one of rotation, compression, extension, and bending for the first region and the second region with adjacent regions having interdependence. The deformation model may include performing rigid registration of the first and second regions to form first and second rigid registrations and stitching together the first and second rigid registrations." [0010]);
b. updating said digital endoluminal map according to said deformations simulated in said second simulation ("3D model 700 may be adjusted based on the deformation model." [0080]).
Regarding claim 29, Kopel discloses all claim limitations, as applied in claim 17, and further discloses wherein said Stress module further comprises instructions to perform one or more of:
a. running a third simulation of said stress levels ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]; here the compression and bending is equivalent to stress in mechanics modeling);
b. updating said navigational actions to cause a reduction in said stress levels ("3D model 700 may be adjusted based on the deformation model." [0080]).
Regarding claim 31, Kopel discloses all claim limitations, as applied in claim 16, and further discloses wherein said assessing deformations further comprises assessing deformation caused by breathing, heartbeats and other causes external to the self-steering endoluminal system ("Due to the flexibility of the lungs, the actual shape of the lungs during the time of a surgical procedure can be deformed or different from the shape at the time of the CT scan and/or initial registration, resulting in the reduction of navigation accuracy ... whereas during the surgical procedure, both registration and navigation, the patient is sedated and breathing normally; (2) the patient may be horizontal for a much longer period during the surgical procedure thereby causing increased deformation; (3) during the surgical procedure, while the bronchoscope is inside of the patient, the head, neck, and superior part of the chest may also be deformed" [0030]).
Regarding claim 32, Kopel discloses all claim limitations, as applied in claim 16, and further discloses wherein said endoluminal device comprises one or more steering mechanisms comprising one or more pull wires, one or more pre-curved shafts, one or more shafts having variable stiffness along a body of said one or more shaft and one or more coaxial tubes ("Catheter guide assembly 90 further includes a handle 91 connected to catheter 96, and which can be manipulated by rotation and compression to steer catheter 96 and/or tools inserted through catheter 96, such as a locatable guide (LG) 92. catheter 96 is sized for placement into the working channel of bronchoscope 50." [0057]; see Fig.1, guide 90, catheter 96 and bronchoscope 50 are all pre-curved; In addition, pull wires are known technique arranged with handle to rotate and steer catheter; see cited pertinent art Zhang);
wherein one or more of said one or more pre-curved shafts and one or more shafts having variable stiffness along a body of said one or more shaft are one within another ("… catheter 96 is sized for placement into the working channel of bronchoscope 50." [0057]); and
wherein said one or more steering mechanisms are configured to cause one or more steering actions comprising rotation of the shaft, advancing/retracting the shaft, deflection of the tip of the device and deflection of a part of the shaft of the device ("… a handle 91 connected to catheter 96, and which can be manipulated by rotation and compression to steer catheter 96 and/or tools inserted through catheter 96 …" [0057]).
Regarding claim 35, Kopel discloses all claim limitations, as applied in claim 16, and further discloses wherein said computer memory storage medium further comprises instructions for tracking at least a partial curve of said endoluminal device ("The location of EM sensors 94, 95, and thus distal tip 93 of catheter 96, within an EM field generated by EM field generator 76, can be derived by tracking module 72 and computing device 80." [0057]).
Regarding claim 36, Kopel discloses all claim limitations, as applied in claim 35, and further discloses incorporating data from said tracking into said digital endoluminal map ("The position of LG 92 is tracked during this registration phase, and the 3D model is iteratively updated based on the tracked position of LG 92 within the actual airways of the patient's lungs." [0068]).
Regarding claim 37, Kopel discloses all claim limitations, as applied in claim 35, and further discloses assessing said deformations of said one or more lumens from said one or more lumens according to a result of said tracking of said at least a partial curve of said endoluminal device ("… navigating a luminal network with a tool including a location sensor … assigning potential matches a registration score based on a distance between the potential match and the location data, and a deformation model applied to the image." [0072]).
Regarding claim 38, Kopel discloses all claim limitations, as applied in claim 35, and further discloses updating said steering plan according to a result of said tracking of said at least a partial curve of said endoluminal device ("… and the 3D model is iteratively updated based on the tracked position of LG 92 within the actual airways of the patient's lungs." [0068]; the navigation pathway is based on 3D model, updating 3D model is equivalent to updating steering plan).
Regarding claim 39, Kopel discloses all claim limitations, as applied in claim 35, and further discloses updating said digital endoluminal map according to a result of said tracking of said at least a partial curve of said endoluminal device ("… and the 3D model is iteratively updated based on the tracked position of LG 92 within the actual airways of the patient's lungs." [0068]).
Regarding claim 40, Kopel discloses all claim limitations, as applied in claim 35, and further discloses assessing stress levels according to a result of said tracking of said at least a partial curve of said endoluminal device ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]; here the compression and bending is equivalent to stress in mechanics modeling; and the inserted catheter is tracked).
Regarding claim 42, Kopel discloses all claim limitations, as applied in claim 16, and further discloses wherein said assessing deformations further comprises assessing deformation caused by said navigational actions performed by said endoluminal device ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]).
Regarding claim 43, Kopel discloses all claim limitations, as applied in claim 1, and further discloses wherein said assessing deformations further comprises assessing deformation caused by said navigational actions performed by said endoluminal device ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]).
Regarding claim 44, Kopel discloses all claim limitations, as applied in claim 1, and further discloses tracking at least a partial curve of said endoluminal device ("The location of EM sensors 94, 95, and thus distal tip 93 of catheter 96, within an EM field generated by EM field generator 76, can be derived by tracking module 72 and computing device 80." [0057]).
Regarding claim 45, Kopel discloses all claim limitations, as applied in claim 44, and further discloses incorporating data from said tracking into said digital endoluminal map ("The position of LG 92 is tracked during this registration phase, and the 3D model is iteratively updated based on the tracked position of LG 92 within the actual airways of the patient's lungs." [0068]).
Regarding claim 46, Kopel discloses all claim limitations, as applied in claim 44, and further discloses assessing said deformations of said to one or more lumens from said one or more lumens according to a result of said tracking of said at least a partial curve of said endoluminal device ("… navigating a luminal network with a tool including a location sensor … assigning potential matches a registration score based on a distance between the potential match and the location data, and a deformation model applied to the image." [0072]).
Regarding claim 47, Kopel discloses all claim limitations, as applied in claim 44, and further discloses updating said steering plan according to a result of said tracking of said at least a partial curve of said endoluminal device ("… and the 3D model is iteratively updated based on the tracked position of LG 92 within the actual airways of the patient's lungs." [0068]; the navigation pathway is based on 3D model, updating 3D model is equivalent to updating steering plan).
Regarding claim 48, Kopel discloses all claim limitations, as applied in claim 44, and further discloses updating said digital endoluminal map according to a result of said tracking of said at least a partial curve of said endoluminal device ("… and the 3D model is iteratively updated based on the tracked position of LG 92 within the actual airways of the patient's lungs." [0068]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim 3, 10 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Kopel, as applied in claim 1 and 17 respectively, and further in view of Yeung et al. (US 2018/0296281 A1; published on 10/18/2018) (hereinafter "Yeung").
Regarding claim 3, Kopel teaches all claim limitations, as applied in claim 1, except wherein said updating said steering plan is performed in real-time.
However, in the same field of endeavor, Yeung teaches wherein said updating said steering plan is performed in real-time ("… wherein the steering control output signal adapts to changes in the data of the first image data stream in real time …" [0209]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the catheter navigation as taught by Kopel with automated steering control as taught by Yeung. By applying real-time 3D mapping, it is possible to provide automated steering "for improved performance" (see Yeung; [0005]).
Regarding claim 10, Kopel teaches all claim limitations, as applied in claim 1, and Kopel further teaches wherein said method further comprises one or more of the following:
wherein assessing deformations comprises running a second simulation of said deformations ("The deformation model may further include modeling at least one of rotation, compression, extension, and bending for the first region and the second region independently. The deformation model may also include modeling at least one of rotation, compression, extension, and bending for the first region and the second region with adjacent regions having interdependence. The deformation model may include performing rigid registration of the first and second regions to form first and second rigid registrations and stitching together the first and second rigid registrations." [0010]); and further comprising updating said digital endoluminal map according to said deformations simulated in said second simulation ("3D model 700 may be adjusted based on the deformation model." [0080]);
wherein assessing stress levels comprises running a simulation of said stress levels ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]; here the compression and bending is equivalent to stress in mechanics modeling); and further comprising updating said navigational actions to cause a reduction in said stress levels ("3D model 700 may be adjusted based on the deformation model." [0080]).
In addition, in the same field of endeavor, Yeung teaches wherein generating navigational actions comprises running a first simulation of said navigational actions ("Thus a motion vector between current location and the position predicted by the target navigation direction may be generated by incorporating the dynamics of the robotic system in view of the navigation direction." [0099]; "… data relating to the dynamics or kinematics of the robotic system may also be incorporated into the ANN to generate control signals that are sent to the actuation unit." [0146]; here the prediction is a simulation based on previous dynamics).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the catheter navigation as taught by Kopel with automated steering control as taught by Yeung. By applying real-time 3D mapping, it is possible to provide automated steering "for improved performance" (see Yeung; [0005]).
Regarding claim 21, Kopel teaches all claim limitations, as applied in claim 17, and Kopel further teaches wherein said Navigational module comprises instructions to perform one or more of:
a. generating navigational actions to be performed by said steerable elongated body of said endoluminal device to aid reaching ("Once the 3D model is generated, the 3D model and treatment plan may be loaded at step 806, into computing device 80 for use by application 81 in conjunction with EMN system 100." [0082]) a desired location as selected in a digital endoluminal map ("… a treatment plan and the identification of targets within the CT image data set to which a catheter is to be navigated within the patient can be identified and pathways to these targets are established as part of the treatment plan described in greater detail above." [0081]).
In addition, in the same field of endeavor, Yeung teaches b. running a first simulation of said navigational actions ("Thus a motion vector between current location and the position predicted by the target navigation direction may be generated by incorporating the dynamics of the robotic system in view of the navigation direction." [0099]; "… data relating to the dynamics or kinematics of the robotic system may also be incorporated into the ANN to generate control signals that are sent to the actuation unit." [0146]; here the prediction is a simulation based on previous dynamics).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the catheter navigation as taught by Kopel with automated steering control as taught by Yeung. By applying real-time 3D mapping, it is possible to provide automated steering "for improved performance" (see Yeung; [0005]).
Claim 4, 41, 49 and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Kopel, as applied in claim 1 and 18 respectively, and further in view of Sganga et al. (US 2021/0393335 A1; filed on 07/30/2021) (hereinafter "Sganga").
Regarding claim 4, Kopel teaches all claim limitations, as applied in claim 1, and Kopel further teaches wherein said method further comprises assessing stress levels on said lumens caused by said navigational actions performed by said endoluminal device ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]; here the compression and bending is equivalent to stress in mechanics modeling).
Kopel fails to explicitly teach wherein said method is performed until said stress levels are below a predetermined threshold.
However, in the same field of endeavor, Sganga teaches wherein said method further comprises assessing stress levels on said lumens caused by said navigational actions performed by said endoluminal device ("… a force or pressure sensor that is designed and otherwise adapted to detect a force to which the portion of the catheter or other device that includes the sensor is subjected." [0076]); and
wherein said method is performed until said stress levels are below a predetermined threshold ("… the tip of the catheter or other device is oriented in the desired direction (vis-à-vis the predesignated pathway determined by the system), the catheter or other device is being advanced without exceeding a threshold force or pressure …" [0095]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the catheter navigation as taught by Kopel with additional force sensor based closed-loop steering control as taught by Sganga. Doing so would make it possible to "ensure that unintentional, potentially misguided, and/or dangerous maneuvers being performed by a robotic system are prevented" (see Sganga; [0077]).
Regarding claim 41, Kopel teaches all claim limitations, as applied in claim 18, except wherein said actuate said steerable elongated body of said endoluminal device comprises actuate said steerable elongated body of said endoluminal device to cause a reduction in said stress levels.
However, in the same field of endeavor, Sganga teaches wherein said actuate said steerable elongated body of said endoluminal device comprises actuate said steerable elongated body of said endoluminal device to cause a reduction in said stress levels ("… once the force detected by such a sensor exceeds a particular high threshold value, the system is configured to direct the robotic system to cease, retract, and/or take other appropriate steps … to ensure that the force generated by attempting to advance the corresponding catheter or other device through the subject does not reach an undesirable value." [0077]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the catheter navigation as taught by Kopel with additional force sensor based closed-loop steering control as taught by Sganga. Doing so would make it possible to "ensure that unintentional, potentially misguided, and/or dangerous maneuvers being performed by a robotic system are prevented" (see Sganga; [0077]).
Regarding claim 49, Kopel in view of Sganga teaches all claim limitations, as applied in claim 4, and Kopel further teaches assessing said stress levels by tracking at least a partial curve of said endoluminal device ("Lungs, lobes, segments, airways or other regions in the lung can be modeled to rotate independently of each other, extend, compress, or bend. The likelihood of a particular deformation may be considered identical for the entire lungs or may change depending on ... inserted catheter ..." [0034]; here the compression and bending is equivalent to stress in mechanics modeling; and the inserted catheter is tracked).
Regarding claim 50, Kopel in view of Sganga teaches all claim limitations, as applied in claim 4, and Sganga further teaches actuating a steerable elongated body of said endoluminal device to cause a reduction in said stress levels ("… once the force detected by such a sensor exceeds a particular high threshold value, the system is configured to direct the robotic system to cease, retract, and/or take other appropriate steps … to ensure that the force generated by attempting to advance the corresponding catheter or other device through the subject does not reach an undesirable value." [0077]).
It would have been prima facie obvious to one ordinary skilled in the art before the effective filing date of the invention to modify the catheter navigation as taught by Kopel with additional force sensor based closed-loop steering control as taught by Sganga. Doing so would make it possible to "ensure that unintentional, potentially misguided, and/or dangerous maneuvers being performed by a robotic system are prevented" (see Sganga; [0077]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhang et al. (US 2022/0313375 A1; priority date on 12/19/2019) teach a robotic bronchoscopy with bending section articulated by one or more pull wires.
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/CHAO SHENG/ Primary Examiner, Art Unit 3797
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