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 Amendment
The Amendment filed on 12/18/2025 has been entered. Claims 1-7 are pending in the application. In response to Applicant's amendments, Examiner withdraws the previous objections to the Drawings, the Specification, and the “spatial relationship” of claim 1. Examiner maintains the objections to the Abstract and the other objections to the claims.
Response to Arguments
Applicant’s arguments with respect to the objections to claims 1-4 and 7 have been fully considered but they are not persuasive. Though Applicant states that the claims have been amended to address the objections (Applicant’s Remarks, p. 8), claims 2-4 are not amended and the amendments to claims 1 and 7 do not address all the objections to these claims.
Applicant’s arguments filed 12/18/2025 with respect to the rejections of claims 1-7 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.
Election/Restrictions
Election of Group I, encompassing claims 1-7, was made without traverse in the reply filed on 08/06/2025. Claims 8-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Specification
The abstract of the disclosure is objected to because “between… to” should read either “between… and” or “from… to”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1-4 and 7 are objected to:
In claim 1, “between… to” should read either “between… and” or “from… to”.
In claim 2, “anatomical structures” should read “the anatomical structures” as anatomical structures are previously recited in claim 1.
In claim 2, “deriving, based on the 3D models, spatial relationships” should read “deriving, based on the 3D models, the spatial relationships” as spatial relationships are previously recited in claim 1.
Claim 3 recites “retrieving a subsequent pose on the preplanned path as a candidate next pose; adopting the candidate next pose as the next pose if the candidate next pose does not cause collision or present a risk of collision with any of the anatomical structures; and modifying the candidate next pose to derive the next pose to avoid a collision or prevent a risk of collision with any of the anatomical structures.” As written, every candidate next pose is modified. However, the specification suggests that the candidate next pose is not modified if there is no collision risk; see [0050]-[0051]. For the purpose of examination, these limitations have been interpreted as “retrieving a subsequent pose on the preplanned path as a candidate next pose; and adopting the candidate next pose as the next pose if the candidate next pose does not cause a collision or present a risk of collision with any of the anatomical structures; or modifying the candidate next pose to derive the next pose to avoid a collision or prevent a risk of collision with any of the anatomical structures if the candidate next pose causes a collision or presents a risk of collision with any of the anatomical structures.”
Claims 3 and 4 are objected to because determination of a collision or a risk of collision with respect to the candidate next pose are not supported in the Specification. In paragraphs [0040], [0046], and [0049]-[0050], the possibility of collision is assessed with respect to the current pose or a previous pose.
In claim 4, “an anatomical structure” should read “an anatomical structure of the anatomical structures” as anatomical structures are previously recited in claim 1.
In claim 7, the limitation “retrieving constructed…” does not recite what is being retrieved. This limitation previously read “retrieving the 3D models constructed…” but should have read “retrieving 3D models constructed…” as no 3D models had been previously recited in claim 7. For the purpose of examination, this limitation has been interpreted as “retrieving 3D models constructed for characterizing the anatomical structures of the patient”.
In claim 7, “a starting 3D pose for the entry on the skin of the patient” has been interpreted as the same 3D entry pose previously recited in claim 1; therefore, this limitation should read “the 3D entry pose” for consistency. Similarly, “an ending 3D pose of the target” has been interpreted as the same 3D pose of the target previously recited in claim 1 and should be referred to consistently.
Appropriate correction is required.
Claim Interpretation
Claim 1 recites “a target” and “a 3D pose of the target” with reference to a preplanned path of a surgical instrument. A “target” has been interpreted as a location of the surgical instrument at the end of the preplanned path. If the “target” referred to an object to be operated on (for example, the target object 100 as depicted in Fig. 1), it would not make sense to compare a current pose of the surgical instrument with a pose of the object as recited in the repeating step of claim 1.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Though Applicant states support for the amendments to claim 1 is present in paragraphs [0042-0046], Examiner disagrees.
In claim 1, the limitation “wherein the spatial relationships are treated differently based on different anatomical structures” does not have support in the disclosure of application 18465288 as originally filed on 09/12/2023. The closest support found in the specification is quoted below:
“In some embodiments, the size of the anatomical structure that is obstructing the desired needle vector v_d as well as the how much the surgical instrument needs to be bended to reach the next target instrument pose may also be considered and incorporated into the equation to determine if the needle path can avoid the organ collision.” [0046]
This quotation does not provide sufficient support for the particular limitation of “wherein the spatial relationships are treated differently based on different anatomical structures”. Specifically, the spatial relationships are spatial relationships of the surgical instrument or the surgical instrument’s next pose to surrounding anatomical structures according to claim 1. The size of the anatomical structures are therefore not spatial relationships. Examiner did not find another instance in the specification where differences between anatomical structures are considered. Thus, claim 1 is rejected under 35 U.S.C. 112(a).
Claims 2-7 are rejected for depending upon the rejected claim 1.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3 and 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Neubach and Shoham (US 20110112549 A1; hereafter “Neubach”) in view of Jiang et al. (WO 2022199650 A1; hereafter “Jiang”), Li et al. (WO 2022199649 A1; hereafter “Li”), and D’Amelio et al. (US 11123139 B2; hereafter “D’Amelio”). Citations of Jiang and Li refer to the paragraph numbers of the respective English translations. Note that the translations of both Jiang and Li use “punching” and “drilling” interchangeably to refer to inserting a surgical instrument.
Regarding claim 1, Neubach discloses
A method implemented on at least one processor, a memory, and a communication platform (Neubach describes a control system / system computer 28 which analyzes sensor data, runs “the motion control loop,” and communicates with a surgical robot using data link 29 [0083].), comprising:
retrieving a preplanned path generated for a surgery on a patient with respect to a target inside the patient (See “In step 55, a calculation is made… to determine the series of needle base motions necessary in order that the tip of the needle follows the predetermined trajectory” [0110]. This predetermined trajectory (preplanned path) is from a needle tip entry point 36 to a target 34 inside patient tissue 20; see Fig. 3A, [0086], and [0106]-[0109]. A person of ordinary skill in the art would recognize that the predetermined trajectory would be stored in and retrieved from memory of control system computer 28 in order to be compared with the detected needle position in step 59 and calculate the next movement in step 64 [see Fig. 9]. See also [0097] and [0104].),
wherein the preplanned path is between a… entry pose on skin of the patient to a… pose of the target and provided to a robot to insert a surgical instrument from the… entry pose to reach the… pose of the target (The predetermined trajectory (preplanned path) in paragraph [0110] is from a needle tip entry point 36 inserted at an angle theta to a target 34 inside patient tissue 20; see Fig. 3A, [0086], and [0106]-[0109]. The location of the entry point and angle theta together form an entry pose of the needle (surgical instrument) 30. “The controller also optimizes needle orientation to minimize lateral tissue pressure,” and the orientation and the location of the target 34 together specify a target needle pose [0096].);
determining a next pose for the surgical instrument based on a current pose of the surgical instrument; the preplanned path; and spatial relationships to surrounding anatomical structures (See “In step 59, the error in the position of the needle tip [current position] from its desired position [position along preplanned path], is calculated. This error level is added to the position reached in order to generate the desired position for the next incremental insertion step” [0114]. Since the preplanned trajectory/path is calculated based on the position of obstacles seen in imaging, the next incremental insertion step (next pose) is also based on the spatial relationships to surrounding anatomical structures; see [0097] and [0108]. See also [0039] and [0119].),
controlling the robot to move the surgical instrument to reach the next pose (See “The updated [tissue stiffness] model from step 63 is used in order to calculate… the robot movement necessary to move the needle [surgical instrument] tip towards the intended target in the next incremental step… To this calculated new target point is also added the error correction from step 59, and the robot is then instructed to move to this combined next desired iteration position” [0119]. See also Fig. 9.);
obtaining an updated current pose of the surgical instrument via tracking when the robot is advancing the surgical instrument to the next pose (See “In step 58, the position of the needle tip is determined, by image processing based on the image differences between the previous image… and the current image” [0113].);
repeating the steps of determining, controlling, and obtaining if the updated current pose is not the… pose of the target determined based on a predetermined criterion (See the loop in Fig. 9: determining in steps 59 and 64, controlling in step 64, and obtaining in steps 57 and 58. The loop “repeats itself, until the final iteration [predetermined criterion] has been performed and the intended target [is] reached” [0120]. See also [0039], [0118]-[0119], and steps 60 and 65 in Fig. 9.).
However, Neubach does not explicitly teach “at least one processor”, “a memory,” “wherein the preplanned path is between a three dimensional (3D) entry pose on skin of the patient to a 3D pose of the target,” “wherein the spatial relationships are treated differently based on different anatomical structures;” nor “outputting a signal indicating that the surgical instrument reaches the 3D pose of the target when the updated current pose reaches the 3D pose of the target based on the predetermined criterion.”
Neubach states that “although the invention has been described using control in only 2-dimensions, …the method and apparatus are equally useable with 3-dimensional controlled motion” [0121]. Jiang teaches an implementation of a similar control method in 3D.
Jiang, in the same field of endeavor (robotic surgical methods), teaches
A method implemented on at least one processor, a memory… (See “an embodiment of the present invention also provides an electronic device, which includes a processor and the computer-readable storage medium [memory], and the processor is used to execute a program [method] stored on the computer-readable storage medium” [0172].), comprising:
wherein the preplanned path is between a three dimensional (3D) entry pose on skin of the patient to a 3D pose of the target and provided to a robot to insert a surgical instrument from the 3D entry pose to reach the 3D pose of the target (See “The control unit is configured to establish a three-dimensional model based on the first image information, and to plan a first path of the punching device 10 based on the first hole [entry] position M1, the three-dimensional model and the predetermined [target] position qgoal, so that when the [robotic] tool arm 210 drives the punching device [surgical instrument] 10 to move along the first path, the conical tip 11 [of the punching device 10] can reach the predetermined position qgoal and complete the punching operation” [0090]. Since the tool arm 210 is controlled through inverse kinematics, the entire path, including the 3D entry pose at M1 and the 3D pose at the target qgoal-, is associated with calculated 3D poses [0149]. See also [0110].).
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 the surgical path following method of Neubach to plan a path and monitor progress in three dimensions as taught by Jiang. One of ordinary skill in the art would have been motivated to make this modification for the benefit of “avoiding the problem of inaccurate [entry] position M caused by different vital sign states [misaligned tracking] of the surgical object, and laying a good foundation for subsequent drilling operations and surgical operations” (Jiang, [0125]).
However, Neubach/Jiang does not explicitly teach “wherein the spatial relationships are treated differently based on different anatomical structures;” nor “outputting a signal indicating that the surgical instrument reaches the 3D pose of the target when the updated current pose reaches the 3D pose of the target based on the predetermined criterion.”
Li, in the same field of endeavor (robotic surgical methods), teaches
outputting a signal indicating that the surgical instrument reaches the 3D pose of the target when the updated current pose reaches the 3D pose of the target… (See “when the robot arm 100 moves to the target drilling posture, the control module 600 also generates a prompt message to prompt that the drilling guidance is completed. The doctor-side control device 10 and the image-side control device 20 receive the prompt information and issue [output a signal] a prompt” [0129]. In Figs. 1 and 2, a surgical instrument 170 is attached to the end of a robot arm 100. The target posture is determined in 3D because the collision model S used for path planning is a 3D shape covering “the entire body surface of the patient” [0103]. See also [0128].).
Although the target drilling posture of Li is on the surface of the patient’s body (before insertion), a similar signal of completion of a planned trajectory to an interior target is useful for prompting the beginning of a procedure at the target location. Since Neubach/Jiang teaches “that the surgical instrument reaches the 3D pose of the target when the updated current pose reaches the 3D pose of the target based on the predetermined criterion” (see repeating step above), the combination of Neubach/Jiang/Li as a whole teaches the limitation “outputting a signal indicating that the surgical instrument reaches the 3D pose of the target when the updated current pose reaches the 3D pose of the target based on the predetermined criterion.”
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 the surgical path following method of Neubach/Jiang with the completion prompt of Li. One of ordinary skill in the art would have been motivated to make this modification so that “the operator can confirm the actual drilling [target] position” (Li, [0083]).
However, Neubach/Jiang/Li does not explicitly teach “wherein the spatial relationships are treated differently based on different anatomical structures.”
D'Amelio, in the same field of endeavor (robotic surgical methods), teaches
wherein the spatial relationships are treated differently based on different anatomical structures (D’Amelio teaches creation of a buffer zone (“clearance section” in which the surgical instrument is prohibited to be) with a set thickness d/2, where d is the diameter of the surgical instrument. However, “The use of d/2 in the model to reduce the size of the surgical zones is exemplary and may be modified… For example, it may be more critical to hit an artery than a bone, so the clearance around an artery may be set to some distance greater than zero, whereas the clearance around a bone may remain at or near zero. This is shown in FIG. 7C, in which obstacle 723 has been expanded to include instrument-width section 773 and clearance section 783” [col. 4, lines 30-41]. Therefore, the spatial relationships of the example artery and bone are treated differently. See also col. 3, line 32 to col. 5, line 15 for more on the anatomical model and generating trajectories.).
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 the surgical path following method of Neubach/Jiang/Li to provide a minimum clearance around anatomical structures, where the clearance varies depending on the type of anatomical structure as taught by D'Amelio. One of ordinary skill in the art would have been motivated to make this modification “if, for example, some obstacle is more important to avoid than another, and the surgeon would like [additional] clearance around the obstacle,” such as an artery (D'Amelio; col. 4, lines 30-41).
Regarding claim 2, Neubach/Jiang/Li/D'Amelio discloses the limitations of claim 1 as addressed above. Neubach additionally discloses computing the next pose according to a planned path from an entry pose to a target pose [0119] (see the rejection of claim 1 above).
Jiang additionally discloses
wherein the step of determining the next pose comprises: retrieving 3D models constructed to characterize anatomical structures of the patient (Jiang teaches planning a local path when an obstacle is encountered on the preplanned global path during a procedure [0092]. To do so, “the control unit is configured to establish an artificial potential field according to the three-dimensional model and the predetermined position qgoal, and plan the first local path according to the artificial potential field” [0140]. The three-dimensional model is updated periodically using image data from an endoscope, so it must be retrieved repeatedly for updated planning [0133]. As shown in Fig. 15, the 3D model contains a plurality of potential obstacles (anatomical structures) with an expanded tissue boundary S1 [0148].);
deriving, based on the 3D models, spatial relationships between the current pose of the surgical instrument and at least some of the anatomical structures (See “the control unit is configured to establish an artificial potential field according to the three-dimensional model and the predetermined position qgoal, and plan the first local path according to the artificial potential field” [0140]. The full equations for the artificial potential field are given at the bottom of page 10 of the original publication and explanation of the variables given in paragraph [0145], calculated for the surgical instrument at a current position q [0146]. The spatial relationships specified include “d(q,qgoal) is the distance between the position q and the predetermined position qgoal; [and] D(q) is the distance of the nearest obstacle to the position q (the target tissue that may collide with the punching device),” where qgoal is located at an anatomical structure and an obstacle is an anatomical structure [0145]. See also [0150], [0155], and Figs. 5 and 15.); and
computing the next pose based on the spatial relationships and the 3D pose of the target in the preplanned path (See “The control unit can calculate the force generated by the artificial potential field... acting on the conical tip 11 [of the punching device 10/surgical instrument] at any position on the first [preplanned] global path L1, and plan the first local path accordingly to perform local correction on the first global path L1 and avoid the obstacle” [0146]. The artificial potential field is based on spatial relationships and the 3D pose at the target, qgoal, as explained above. The poses on the first local path are calculated using inverse kinematics [0149].),
wherein the spatial relationships include a distance to and a spatial configuration with respect to each of the at least some of the anatomical structures (The spatial relationships specified in the artificial potential field equations include “d(q,qgoal) is the distance between the position q and the predetermined position qgoal; [and] D(q) is the distance of the nearest obstacle to the position q (the target tissue that may collide with the punching device)” [0145]. See the spatial configurations with respect to qgoal in Fig. 5 and with respect to obstacles in Fig. 15 below. See also [0146] and [0148].).
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Figure A: Fig. 5 of Jiang
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Figure B: translated Fig. 15 of Jiang
Regarding claim 3, Neubach/Jiang/Li discloses the limitations of claim 2 as addressed above, and Neubach additionally discloses
wherein the step of computing the next pose comprises: retrieving a subsequent pose on the preplanned path as a candidate next pose; adopting the candidate next pose as the next pose… (See “The updated model from step 63 is used in order to calculate… the robot movement necessary to move the needle tip towards the intended target in the next incremental step [next pose from the previous desired position on the predetermined trajectory]… To this calculated new target point is also added the error correction from step 59 [correction from the current position to the previous desired position], and the robot is then instructed to move to this combined next desired iteration position [to candidate next pose]” [0119]. See also [0039]; the increments of the predetermined trajectory are determined before insertion.);
Neubach additionally discloses computing the next pose according to a planned path [0119] (see above).
Jiang additionally discloses
adopting the candidate next pose as the next pose if the candidate next pose does not cause collision or present a risk of collision with any of the anatomical structures (The control unit continuously monitors “punching status information” [0101], which includes a probability of collision with the closest tissue (anatomical structure) [0150]. If the control unit “determines that the collision probability is small, [the control unit] does not generate the collision prompt information” (e.g., activation of an alarm; see [0161]) [0160]. The control unit does not need to plan a first local path to avoid an obstacle, so the punching device continues to “move along the first [preplanned] global path L1” [0101], which involves moving to the candidate next pose on the path [0149]. Additionally, if the punching device 10 is already following a first local path, the control unit can adopt the next pose on the local path because the local path is planned to avoid an obstacle encountered after the surgery has started based on image data and a 3D model [0101]. See kinematics computation of poses for planned paths in [0149]. See also [0131].); and
modifying the candidate next pose to derive the next pose to avoid a collision or prevent a risk of collision with any of the anatomical structures (“If the punching device encounters an obstacle, the control unit also plans the first local path and drives the punching device 10 to move along the first local path and temporarily deviate from the first global path L1 to avoid the obstacle, and return to the global path L1 after avoiding the obstacle until the punching operation is completed” [0101]. An obstacle is a tissue (anatomical structure) [0145]. See [0140]-[0149] for the method of planning a first local path and [0156]-[0160] for calculating a risk of collision. Since the start and end of the first local path are on the first global path [0139], to follow the first local path from its starting pose means that the candidate next pose on the first local path is modified to avoid a collision until the punching device 10 returns to the first global path L1. See kinematics computation of poses for planned paths in [0149].).
Regarding claim 5, Neubach/Jiang/Li/D'Amelio discloses the limitations of claim 1 as addressed above, and Jiang additionally discloses
wherein the step of controlling the robot comprises: determining differences between a first set of parameters used to configure the robot to move the surgical instrument to the current pose and a second set of parameters needed to configure the robot to move the surgical instrument to the next pose; and configuring the robot based on the differences to enable the robot to control movement of the surgical instrument from the current pose to the next pose (The first set of parameters is the acceleration, velocity, and position of the joints for the current pose. The second set of parameters is the acceleration, velocity, and position of the joints for the next pose. The first and second sets of parameters (and the current and next poses) are determined when planning the path, and the differences between the sets of parameters results in the punching device 10 moving from the current pose to the next pose as controlled by the control unit and tool arm 210. See “when planning the first path (i.e., the first global path L1 and the first local path), the control unit… obtains the acceleration, velocity and position of the joints on the [robot] tool arm 210 through robot inverse kinematics solution, so that the control unit can drive the joints on the tool arm 210 to move to the corresponding positions according to the acceleration and velocity, thereby driving the punching device [surgical instrument] 10 to move along the first path” [0149]. See also [0096] and [0119] of Neubach.).
Regarding claim 6, Neubach/Jiang/Li/D'Amelio discloses the limitations of claim 1 as addressed above, and Jiang discloses
wherein the predetermined criterion is defined in accordance with a distance between the current pose and the 3D pose of the target (See “the control unit compares the current puncture depth z1 with the expected puncture depth z0, and obtains a ratio thereof as the puncture progress information. The expected drilling depth z0 is the distance from the predetermined [target] position qgoal to the first hole [entry] position M1. Furthermore, when the ratio of the current perforation depth z1 to the expected perforation depth z0 is 1, the control unit determines that perforation is completed” [0154]. The distance between the current pose and the 3D pose of the target is z0-z1, which equals 1 - (z1/z0). Jiang’s predetermined criterion is z1/z0 = 1, which is equivalent to the distance reaching 0.).
Regarding claim 7, Neubach/Jiang/Li/D'Amelio discloses the limitations of claim 1 as addressed above, and Jiang additionally discloses
wherein the preplanned path is generated by: obtaining information related to the patient, and operational parameters associated with the surgery (First imaging (information relating to the patient) is performed to make a “first vital sign image model” of the patient through “three-dimensional reconstruction” and obtain “lesion information” [0110]. Operational parameters, such as registration of the imaging model “with the parameters of the surgical robot system (mainly the parameters of the tool arm 210)” and planning an entry position (“prehole position”) are performed [0110].);
retrieving [3D models] constructed for characterizing the anatomical structures of the patient (At another time, a second exterior imaging device generates data for a “second vital sign image model,” which is registered with the first 3D model; see [0108] and [0110]-[0111]. One of ordinary skill in the art would recognize that the first 3D model would be saved and retrieved to register the second 3D model with the first 3D model [0108]. The “body surface information” and “lesion information” of the first 3D model characterizes anatomical structures of the patient [0105]. Additionally, interior imaging from an endoscope is obtained to update the 3D model; see [0099] and [0133].);
estimating a starting 3D pose for the entry on the skin of the patient… (A “pre-hole position” (entry pose) is planned on the first 3D model [0106] and registered with the second 3D model [0108]. The actual entry pose at the surface (skin) of the patient is determined in Step A15 [0109]. See also [0093], [0110], and [0125]. See also [0077] of Li.);
determining a plurality of 3D poses between the starting 3D pose and the ending 3D pose without collision with the anatomical structures according to the starting 3D pose and the ending 3D pose; and creating the preplanned path based on the starting 3D pose and the ending 3D pose (See “the control unit plans a first global path L1 of the punching device according to the three-dimensional model, the first hole position [starting 3D pose] M1 and the predetermined position” (ending 3D pose) [0100]. The first global path L1 is (pre)planned “according to the expanded three-dimensional model, so that a safety gap [i.e., no collision] exists between the first path and the target tissue” (anatomical structures) [0148]. The control unit calculates “the acceleration, velocity and position [3D poses] of the joints on the tool arm 210 through robot inverse kinematics solution,” and those poses are used to control “the punching device 10 to move along the first path” L1 [0149].).
Neubach additionally discloses
estimating… an ending… pose of the target (See “The desired target is selected by the user on the ultrasound image, and the needle entry point is determined either by the physician using his judgment, or it can be calculated by the control system computer. The calculation is performed by passing a straight line through the target with the same angle as the angle between the needle orientation and the probe” [01]. That straight line through the target provides an estimate of the entry pose and target pose.).
Again, Neubach states that “although the invention has been described using control in only 2-dimensions, …the method and apparatus are equally useable with 3-dimensional controlled motion” [0121]. Jiang provides an entry 3D pose, so Neubach’s 2D method can generate a 3D target pose estimate. D’Amelio additionally teaches extending the 2D clearance sections to a 3D model in col. 4, line 50 to col. 5, line 15. Thus, the combination as a whole teaches the claim.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Neubach in view of Jiang, Li, and D’Amelio; and further in view of Mao et al. (US 20210178590 A1; hereafter “Mao”).
Regarding claim 4, Neubach/Jiang/Li/D'Amelio discloses the limitations of claim 3 as addressed above, and Jiang additionally discloses
wherein the collision is determined based on an orientation associated with the candidate next pose (It is clear that a collision is determined based on orientation because in step S23, a collision time is calculated based on the speed of the surgical instrument. See “the control unit calculates the collision occurrence time t according to the speed of the conical tip and the distance” between the conical tip 11 and a tissue, where “the speed of the conical tip is v1, and the distance is D, [and] the collision occurrence time t satisfies: t=D/v1” [0159]. A valid collision occurrence time t exists only if the tip 11 of the surgical instrument 10 were moving towards the nearby tissue. The direction of movement is defined by the current pose and the candidate next pose and limited by the orientation of the surgical instrument, particularly when using Neubach’s flexible needle.); and
the risk of collision with respect to an anatomical structure is determined based on a distance between the [current] pose and the anatomical structure (See “the control unit calculates the collision occurrence time t according to the speed of the conical tip and the distance” between the conical tip 11 and a tissue, where “the speed of the conical tip is v1, and the distance is D, [and] the collision occurrence time t satisfies: t=D/v1” [0159]. Comparing t with a threshold t0 to determine the collision probability [0160] means the risk of collision with a certain tissue is based on a distance between the current pose and the anatomical structure.).
However, Neubach/Jiang/Li/D'Amelio do not explicitly teach “a distance between the candidate next pose and the anatomical structure.”
Mao, also solving robotic path planning with obstacle avoidance, teaches
the risk of collision with respect to an anatomical structure is determined based on a distance between the candidate next pose and the anatomical structure (When assessing the risk of collision for a candidate next pose, “If the movement from node n [current pose] to a neighbor [candidate next pose] hits an obstacle or is within a distance which is not allowed from the obstacle, the direction of the move may be added to a set of avoidable directions” [0020]. The determination is based on “the one or more candidate next poses being a predetermined distance away from one or more obstacles observed between the current pose and the desired [target] pose” [claim 3]. See “The obstacle(s) may be… a patient's body part,” i.e., an anatomical structure [0013]. )
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 the method of calculating the risk of collision of Neubach/Jiang/Li/D'Amelio to base the calculation at least partly on the distance between the candidate next pose and an anatomical structure as taught by Mao. One of ordinary skill in the art would have been motivated to make this modification to predict a higher risk of collision if a candidate next pose were adopted and avoid possible modified next poses in a direction known to have “a to [sic] high probability that there is an obstacle in the same direction” (Mao, [0020]).
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.
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/MOYA LY/Examiner, Art Unit 3658
/Ramon A. Mercado/Supervisory Patent Examiner, Art Unit 3658