DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Continued Examination Under 37 CFR 1.114
3. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/24/2026 has been entered.
Response to Arguments
4. Applicant’s arguments with respect to claim(s) 1-20 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
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 3, 4, 6, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire U.S. 2016/0361088 (herein referred to as “Maguire”) and in view of Dace U.S. 2023/0241775 (herein referred to as “Dace”).
7. Regarding Claim 1, Maguire teaches a method for endoscopically accessing a pancreaticobiliary region of a patient (see at least Figs. 3, 6A-6B, 14), the method comprising:
a. navigating a steerable elongate instrument through a body cavity or channel toward a stricture adjacent to the pancreaticobiliary region (Fig. 14; para 0137, “the clinician may advance the cannula 105-q further into the bile duct 1405 over the guide wire 155-c (see FIGS. 6A-6B) so that the distal end 120 of the cannula 105-q is closer to the ampulla of Vater 1410 or luminal obstruction”);
b. delivering radio-frequency (RF) energy to an entry site of the stricture via a working head of the steerable elongate instrument to produce an opening to the pancreaticobiliary region (para 0075, “the distal end 145 of the stylet 135-b includes an energizable (e.g., radiofrequency energy) element configured to cut, ablate, or otherwise penetrate through the wall 310 of the body lumen 305. For example, the distal end 145 may include a diathermic or dielectric cutting element including but not limited to a dielectric cautery ring, a cutting knife, a cutting wire, pinching cutters, or the like configured to allow the clinician to ablate or otherwise cut through tissue so as to widen an obstructed pathway or completely remove a tumor or other obstruction”; para 0133, “the cannula 105-q may pierce the wall of the duodenum 1415 and the wall of the common bile duct 1405 by exposing the distal end of a sharpened stylet 135”); and
c. passing at least a distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform a diagnostic or therapeutic operation therein (para 0075, “the distal end 145 of the stylet 135-b includes an energizable (e.g., radiofrequency energy) element configured to cut, ablate, or otherwise penetrate through the wall 310 of the body lumen 305. For example, the distal end 145 may include a diathermic or dielectric cutting element including but not limited to a dielectric cautery ring, a cutting knife, a cutting wire, pinching cutters, or the like configured to allow the clinician to ablate or otherwise cut through tissue so as to widen an obstructed pathway or completely remove a tumor or other obstruction”; Figs. 14 and 15).
Maguire fails to teach (a) the steerable elongate instrument is controlled, without requiring user intervention, by a controller applying a first trained machine-learning model to adjust one or more of a position, an angle, a posture, or a force in real-time based on one or more monitored pancreaticobiliary anatomy characteristics.
Dace teaches a method of accessing a region of a patient (see Figs. 2A and 2B), wherein the method comprising navigating a steerable elongate instrument (Fig. 2A, ref num 205), such that the steerable elongate instrument is controlled, without requiring user intervention, by a controller applying a first trained machine-learning model (para 0023, “a computer-based surgical planning and execution system is configured to control the joints of the robotic system 200, e.g., operating the joints to position and orient the sleeve 208 according to a defined surgical plan”) to adjust one or more of a position, an angle, a posture, or a force in real-time based on one or more monitored anatomy characteristics (para 0023, “The surgical planning and execution system may also be configured to receive sensor data during the surgical procedure from sensors attached to the subject 102 which measure or track the position and orientation of anatomical structures (such as the position and orientation of one or more vertebrae) of the subject 102, and/or the position of one or more surgical tools 210, and adjust the surgical plan in real-time based on the sensor data”). This real-time positioning of the instrument reduces unnecessary damage and injury to the patient (para 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to include a first trained machine-learning model to adjust the position of the elongate instrument based on the anatomy characteristics without user intervention, as this reduces injury to the patient during the procedure.
8. Regarding Claim 3, Maguire teaches the method of claim 1, as well as the RF energy is applied to a stricture beside an ampulla of Vater to produce an opening to a common bile duct (see Fig. 14; para 0132, “the common bile duct 1405 joins with the pancreatic duct 1420 at the ampulla of Vater 1410 (shown obstructed)…”; para 0137, “the guide wire 155-c may then be advanced distally from the distal end 120 of the cannula 105-q and through the bile duct 1405 and across the ampulla of Vater 1410… so that the distal end 120 of the cannula 105-q is closer to the ampulla of Vater 1410 or luminal obstruction to be treated to provide additional support for crossing the luminal obstruction”; para 0003, “the needle is advanced from the endoscope through the duodenal wall and through the wall of the common bile duct proximal to an obstruction near the papilla of the duct, through the obstruction”; para 0075, “the distal end 145 of the stylet 135-b includes an energizable (e.g., radiofrequency energy) element configured to cut, ablate, or otherwise penetrate through… tissue so as to widen an obstructed pathway or completely remove a tumor or other obstruction”).
9. Regarding Claim 4, Maguire teaches the method of claim 1, as well as delivering the RF energy is through an uncoiled wire portion on the working head of the steerable elongated instrument, the uncoiled wire portion electrically coupled to an RF power generator (para 0075; Fig. 14).
10. Regarding Claim 6, Maguire teaches a method for accessing a pancreaticobiliary region of a patient (see at least Figs. 3, 6A-6B, 14), the method comprising:
a. navigating a steerable elongate instrument through a body cavity or channel toward to a stricture adjacent to the pancreaticobiliary region (Fig. 14; para 0137, “the clinician may advance the cannula 105-q further into the bile duct 1405 over the guide wire 155-c (see FIGS. 6A-6B) so that the distal end 120 of the cannula 105-q is closer to the ampulla of Vater 1410 or luminal obstruction”), the steerable elongate instrument extended between a proximal portion and a distal portion (Fig. 1), the distal portion including a working head configured to achieve a higher amount of stiffness than the proximal portion of the steerable elongate instrument as the working head approaches the stricture (para 0081);
b. positioning the working head of the steerable elongate instrument at an entry site of the stricture and applying a mechanical force thereto to produce an opening to the pancreaticobiliary region (para 0074); and
c. passing at least the distal portion of the steerable elongate instrument through the produced opening into the pancreaticobiliary region to perform diagnostic or therapeutic operation therein (para 0074; para 0075, “the distal end 145 of the stylet 135-b includes an energizable (e.g., a radiofrequency energy) element configured to cut, ablate, or otherwise penetrate through the wall 310 of the body lumen 305. For example, the distal end 145 may include a diathermic or dielectric cutting element including but not limited to a dielectric cautery ring, a cutting knife, a cutting wire, pinching cutters, or the like configured to allow the clinician to ablate or otherwise cut through tissue so as to widen an obstructed pathway or completely remove a tumor or other obstruction”; Figs. 14 and 15).
Maguire fails to teach (a) the steerable elongate instrument is controlled, without requiring user intervention, by a controller applying a first trained machine-learning model to adjust one or more of a position, an angle, a posture, or a force in real-time based on one or more monitored pancreaticobiliary anatomy characteristics.
Dace teaches a method of accessing a region of a patient (see Figs. 2A and 2B), wherein the method comprising navigating a steerable elongate instrument (Fig. 2A, ref num 205), such that the steerable elongate instrument is controlled, without requiring user intervention, by a controller applying a first trained machine-learning model (para 0023, “a computer-based surgical planning and execution system is configured to control the joints of the robotic system 200, e.g., operating the joints to position and orient the sleeve 208 according to a defined surgical plan”) to adjust one or more of a position, an angle, a posture, or a force in real-time based on one or more monitored anatomy characteristics (para 0023, “The surgical planning and execution system may also be configured to receive sensor data during the surgical procedure from sensors attached to the subject 102 which measure or track the position and orientation of anatomical structures (such as the position and orientation of one or more vertebrae) of the subject 102, and/or the position of one or more surgical tools 210, and adjust the surgical plan in real-time based on the sensor data”). This real-time positioning of the instrument reduces unnecessary damage and injury to the patient (para 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to include a first trained machine-learning model to adjust the position of the elongate instrument based on the anatomy characteristics without user intervention, as this reduces injury to the patient during the procedure.
11. Regarding Claim 9, Maguire teaches the method of claim 6, as well as the distal portion of the steerable elongate instrument is configured to have axially variable stiffness (para 0081).
12. Regarding Claim 10, Maguire teaches the method of claim 6, as well as the distal portion of the steerable elongate instrument comprises struts spatially arranged to provide variable stiffness as the steerable elongate instrument changes its posture, including an increase in stiffness in response to a change from a bending posture to a straightening posture (Figs. 2B and 8A-8D, ref nums 190; para 0084, 0087; para 0092, “spacing between the apertures 190-a may be varied to impart a variable stiffness”).
13. Claims 7, 11, 13, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire and Dace, and further in view of Knutson.
14. Regarding Claim 7, Maguire teaches the method of claim 6, but fails to teach applying an image of the stricture to a second trained machine-learning (ML) model to identify the entry site of the stricture.
Knutson teaches a method of analogous art (Fig. 1 and 8), wherein the method comprises identifying a navigation path to the abnormal tissue (para 0071, Fig. 8) by applying an image of the tissue (Fig. 8, ref num 802) to a trained machine-learning model (para 0063, “system may analyze preoperative imaging…the system may analyze the preoperative imaging using machine learning-based techniques”; para 0065, “the surgical navigation system utilizes fuzzy logic and/or machine learning to determine and recommend possible paths and/or plans”). Using a machine-learning model to determine the entry site of the stricture improves diagnostic yields and procedure efficiency (para 0023, “applying machine learning techniques…to decision-making and decision-guiding user interfaces to improve diagnostic yields and procedure efficiency. The techniques enable improves catheter system performance”; also see para 0047 and 0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and applied an image of the stricture to a machine-learning model to identify the entry site, as this improves the procedure efficiency.
15. Regarding Claim 11, Maguire teaches an endoscopic system (Fig. 1), comprising:
a. a steerable elongate instrument configured to be positioned and navigated in a patient anatomy (see at least Figs. 3, 6A-6B, 14);
However, Maguire fails to teach (a) the steerable elongate instrument is controlled, without requiring user intervention, to adjust one or more of a position, an angle, a posture, or a force in real-time based on one or more monitored pancreaticobiliary anatomy characteristics; (b) a controller configured to: (b.1) receive an image of a stricture adjacent to a pancreaticobiliary region; and (b.2) apply a first trained machine-learning model to control, without requiring user intervention, the steerable elongate instrument to adjust one or more of the position, the angle, the posture, or the force in real-time based on the one or more monitored pancreaticobiliary anatomy characteristics; (b.3) apply the received image of the stricture to at least one trained machine-learning (ML) model to identify an entry site of the stricture, and to determine a pancreaticobiliary access approach, between (i) an radio frequency (RF)-based approach and (ii) a mechanical puncture-based approach, to access the pancreaticobiliary region; and an output unit configured to provide the determined pancreaticobiliary access approach to a user.
Dace teaches a method of accessing a region of a patient (see Figs. 2A and 2B), wherein the method comprising navigating a steerable elongate instrument (Fig. 2A, ref num 205), such that the steerable elongate instrument is controlled, without requiring user intervention, by a controller applying a first trained machine-learning model (para 0023, “a computer-based surgical planning and execution system is configured to control the joints of the robotic system 200, e.g., operating the joints to position and orient the sleeve 208 according to a defined surgical plan”) to adjust one or more of a position, an angle, a posture, or a force in real-time based on one or more monitored anatomy characteristics (para 0023, “The surgical planning and execution system may also be configured to receive sensor data during the surgical procedure from sensors attached to the subject 102 which measure or track the position and orientation of anatomical structures (such as the position and orientation of one or more vertebrae) of the subject 102, and/or the position of one or more surgical tools 210, and adjust the surgical plan in real-time based on the sensor data”). This real-time positioning of the instrument reduces unnecessary damage and injury to the patient (para 0024). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to include a first trained machine-learning model to adjust the position of the elongate instrument based on the anatomy characteristics without user intervention, as this reduces injury to the patient during the procedure.
Knutson teaches a system of analogous art (Fig. 1), wherein the system comprises a steerable elongate instrument (Figs. 1, ref num 90 and 100) and a controller (Figs. 1 and 2, ref num 80). The controller is configured to: receive an image of a stricture adjacent to a pancreaticobiliary region (para 0063), and apply the received image of the stricture to at least one trained machine-learning (ML) model to identify an entry site of the stricture (para 0063, 0065, 0070; Fig. 8). The controller also determines an access approach between a radio frequency (RF)-based approach and a mechanical puncture-based approach (Fig. 8, ref num 810; Fig. 9), to access the region; and an output unit configured to provide the determined access approach to a user (Fig. 1, ref num 81; Fig. 8, ref num 812). Using a machine-learning model to determine the entry site of the stricture improves diagnostic yields and procedure efficiency (para 0023, “applying machine learning techniques…to decision-making and decision-guiding user interfaces to improve diagnostic yields and procedure efficiency. The techniques enable improves catheter system performance”; also see para 0047 and 0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and applied an image of the stricture to a machine-learning model to identify the entry site, as this improves the procedure efficiency.
16. Regarding Claim 13, Maguire teaches the steerable elongate instrument includes a catheter, a guide wire, or a guide sheath including a lumen to pass a stricture management device therethrough (see Fig. 1).
17. Regarding Claim 15, Maguire teaches the steerable elongate instrument is extended between a proximal portion and a distal portion (see Fig. 1), the distal portion including a working head having a higher amount of stiffness than other portions of the steerable elongate instrument (para 0081), wherein the working head is configured to, in response to a puncture force applied thereto, puncture the entry site of the stricture to produce an opening sized to pass at least the distal portion of the steerable elongate instrument therethrough (para 0074).
18. Regarding Claim 16, Maguire teaches the steerable elongate instrument includes, at a distal portion thereof, a working head configured to be electrically coupled to an RF power generator and to deliver RF energy to the entry site of the stricture to produce an opening sized to pass at least the distal portion of the steerable elongate instrument therethrough (para 0074; para 0075, “the distal end 145 of the stylet 135-b includes an energizable (e.g., a radiofrequency energy) element configured to cut, ablate, or otherwise penetrate through the wall 310 of the body lumen 305. For example, the distal end 145 may include a diathermic or dielectric cutting element including but not limited to a dielectric cautery ring, a cutting knife, a cutting wire, pinching cutters, or the like configured to allow the clinician to ablate or otherwise cut through tissue so as to widen an obstructed pathway or completely remove a tumor or other obstruction”; Figs. 14 and 15).
19. Claims 2 and 14 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire and Dace, and further in view of Knutson U.S. 2024/0206981 (herein referred to as “Knutson”) and Wong U.S. 2024/0324870 (herein referred to as “Wong”).
20. Regarding Claim 2, Maguire teaches the method of claim 1, but fails to teach applying an image of the stricture to a second trained machine-learning (ML) model to identify the entry site of the stricture, wherein one or more geometric or morphological features are extracted from the image of the stricture and applied to the second trained machine-learning model.
Knutson teaches a method of analogous art (Fig. 1 and 8), wherein the method comprises identifying a navigation path to the abnormal tissue (para 0071, Fig. 8) by applying an image of the tissue (Fig. 8, ref num 802) to a trained machine-learning model (para 0063, “system may analyze preoperative imaging…the system may analyze the preoperative imaging using machine learning-based techniques”; para 0065, “the surgical navigation system utilizes fuzzy logic and/or machine learning to determine and recommend possible paths and/or plans”). Using a machine-learning model to determine the entry site of the stricture improves diagnostic yields and procedure efficiency (para 0023, “applying machine learning techniques…to decision-making and decision-guiding user interfaces to improve diagnostic yields and procedure efficiency. The techniques enable improves catheter system performance”; also see para 0047 and 0051). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire and applied an image of the stricture to a machine-learning model to identify the entry site, as this improves the procedure efficiency.
Wong teaches a system of analogous art (Figs. 1, 2, and 13), wherein the system includes an endoscope (Fig. 13; para 0113, “the imaging system includes endoscopic imaging instrument components… in some embodiments, however, a separate endoscope, attached to a separate manipulator assembly may be used with the medical instrument 1304 to image the surgical site”; also see Fig. 10 and para 0071), such that the endoscope comprises an imaging sensor (para 0071, “image sensor”; para 0022, 0036, 0113). The imaging sensor is configured to generate an image of the target tissue (para 0036, 0045), such that one or more geometric or morphological features are extracted from the image of the stricture and applied to a trained machine-learning model (para 0033, “the 3D anatomic model can be generated partially or entirely from intraoperative data obtained during the medical procedure…”; para 0043, “an external sensor (e.g., a stylet, a needle, etc.) can be traced over the surface of the patient's skin and/or over other critical features (e.g., the patient's ribs) to add data points to the point cloud data of the 3D model and to register the external sensor to the point cloud data. Such added data points can indicate valid percutaneous entry points and/or off-limit areas on the patient's skin for percutaneous entry points. Such added data points can also provide information regarding a distance between patient's skin and a tip of the elongate flexible device positioned internal the anatomic structure”; para 0045, “the method 100 can include analyzing the image data using computer vision and/or machine learning techniques to automatically… identify the target”; para 0076, “The image data can be analyzed to identify the current geometry and/or locations of the target, anatomic structure, and/or sensitive tissue structures, such as based on user input, using computer vision and/or machine learning techniques, and/or a combination thereof…”). By applying these features to a trained machine-learning model, this revises the procedure/operations in real-time to improve the overall treatment to the tissue (para 0076, 0077). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to have applied geometric/morphological features of an image to a second trained machine-learning model in order to improve the real-time procedure.
21. Regarding Claim 14, Maguire teaches the steerable elongate instrument includes an endoscope (see Fig. 1), but fails to teach the endoscope including an imaging sensor to generate the image of the stricture.
Wong teaches a system of analogous art (Figs. 1, 2, and 13), wherein the system includes an endoscope (Fig. 13; para 0113, “the imaging system includes endoscopic imaging instrument components… in some embodiments, however, a separate endoscope, attached to a separate manipulator assembly may be used with the medical instrument 1304 to image the surgical site”; also see Fig. 10 and para 0071), such that the endoscope comprises an imaging sensor (para 0071, “image sensor”; para 0022, 0036, 0113). The imaging sensor is configured to generate an image of the target tissue (para 0036, 0045). The image aids in locating the target tissue site (para 0036-0037). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to include an imaging sensor to image the stricture, as this aids in finding the location of the target site.
22. Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire and Dace, and further in view of Neal U.S. 2022/0387095 (herein referred to as “Neal”).
23. Regarding Claim 5, Maguire teaches the method of claim 1, but fails to teach adjusting an RF energy delivered to the entry site of the stricture based at least on a characteristic of the stricture.
Neal teaches a method of analogous art (Figs. 1 and 28), wherein the method comprises adjusting an RF energy delivered to the target tissue based on a characteristic of the tissue (para 0381, “a feedback control loop can be configured to modify a parameter of energy delivery based on the measured one or more system of tissue parameters”). This allows for mapping of treatment areas before, during, and after treatment (para 0379). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to adjust RF energy based on a characteristic of the stricture, as this provides feedback that is beneficial to planning and modifying the treatment.
24. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Maguire and Dace.
25. Regarding Claim 8, Maguire teaches the method of claim 6, but fails to teach the working head is made of material through a rigidization process. However, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698; 227 USPQ 964, 966 (Fed. Cir. 1985). Since the working head is made of a material that is stiff/rigid (Maguire, para 0081), then this reads on the claimed language.
26. Claims 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire and Dace, and further in view of Jaramaz U.S. 2023/0363831 (herein referred to as “Jaramaz”).
27. Regarding Claim 17, Maguire as modified fails to teach the steerable elongate instrument is robotically controlled via a robot arm configured to adjust one or more of the position the angle, the posture, or the force in real-time based on the one or more monitored pancreaticobiliary anatomy characteristics.
Jaramaz teaches a method of analogous art (Figs. 1, 5A, 5B), wherein the method comprises the steerable elongate instrument is robotically controlled via a robot arm (Fig. 1, ref num 105a controls ref nums 105B-D; para 0066, “robotic arm 105a can be controlled by the CASS 100 to position a cutting guide or jig 105D”) configured to adjust one or more of the position the angle, the posture, or the force in real-time based on the one or more monitored pancreaticobiliary anatomy characteristics (para 0066, “in accordance with a pre-operatively or intraoperatively developed surgical plan”; para 0128-0129; Fig. 5B, ref num 115). These adjustments are made in order to place the instrument at the proper location of the target site in order to deliver the treatment to said target site (para 0104-0105). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to control the instrument via a robot arm in order to place the instrument at the target site for treatment at the target site.
28. Regarding Claim 19, Maguire fails to teach the robot arm is detachably connected to the steerable elongate instrument.
Jaramaz teaches the robot arm is detachably connected to the steerable elongate instrument (para 0066, “Such cutting guides 105D can be formed integrally as part of the Effector Platform 105 or Robotic Arm 105A, or cutting guides can be separate structures that can be matingly and/or removably attached to the Effector Platform 105 or Robotic Arm 105A”). This allows for personalized treatment based on the parameter to be adjusted (para 0092). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to have the robot arm detachably connected the steerable elongate instrument in order to personalize the treatment based on the type of parameter to be adjusted when monitoring anatomy characteristics.
29. Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Maguire, Dace, and Knutson, and further in view of Jaramaz.
30. Regarding Claim 18, Maguire as modified fails to teach the steerable elongate instrument is robotically controlled via a robot arm configured to adjust one or more of the position the angle, the posture, or the force in real-time based on the one or more monitored pancreaticobiliary anatomy characteristics.
Jaramaz teaches a method of analogous art (Figs. 1, 5A, 5B), wherein the method comprises the steerable elongate instrument is robotically controlled via a robot arm (Fig. 1, ref num 105a controls ref nums 105B-D; para 0066, “robotic arm 105a can be controlled by the CASS 100 to position a cutting guide or jig 105D”) configured to adjust one or more of the position the angle, the posture, or the force in real-time based on the one or more monitored pancreaticobiliary anatomy characteristics (para 0066, “in accordance with a pre-operatively or intraoperatively developed surgical plan”; para 0128-0129; Fig. 5B, ref num 115). These adjustments are made in order to place the instrument at the proper location of the target site in order to deliver the treatment to said target site (para 0104-0105). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to control the instrument via a robot arm in order to place the instrument at the target site for treatment at the target site.
31. Regarding Claim 20, Maguire fails to teach the robot arm is detachably connected to the steerable elongate instrument.
Jaramaz teaches the robot arm is detachably connected to the steerable elongate instrument (para 0066, “Such cutting guides 105D can be formed integrally as part of the Effector Platform 105 or Robotic Arm 105A, or cutting guides can be separate structures that can be matingly and/or removably attached to the Effector Platform 105 or Robotic Arm 105A”). This allows for personalized treatment based on the parameter to be adjusted (para 0092). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Maguire to have the robot arm detachably connected the steerable elongate instrument in order to personalize the treatment based on the type of parameter to be adjusted when monitoring anatomy characteristics.
Allowable Subject Matter
32. Claim 12 contains allowable subject matter allowed. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to specifically teach constructing a training dataset comprising stored procedure data that includes assessments of the pancreaticobiliary access approaches of the respective procedures, wherein the procedure data is screen to include only data from procedures achieving successful cannulation within a specified number of attempts and train the second trained machine-learning model using the training dataset. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
33. Claim 12 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
34. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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