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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 18-31) in the reply filed on March 2, 2026 is acknowledged.
Claim Objections
Claims 18, 22, 25, 26, 28, 29, and 31 is objected to because of the following informalities:
Claim 18 recites “using a FE model….” Claim 18 should be amended to read “using a Finite Element (FE) model.”
Claims 22 and 26 recite “a predefined threshold.” These should be amended to recite “the defined threshold.”
Claim 31 appears to be written in an independent form, yet also refers back to the other independent claim (claim 18). In one interpretation, claim 31 may be construed as an independent computer-readable medium claim. In another interpretation, claim 31 may be construed as a dependent claim. In order to prevent any ambiguity, it is suggested to bring the entire claim 18 (i.e., the computer-implemented method) into claim 31 to have claim 31 construed as a proper independent claim.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 25-29 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 25 recites “…the optimization method is based on an optimization problem searching for arguments of a maxima of the cost function within a predefined search space for the defined position, the defined size and/or the defined external magnetic field, respectively.” Cost functions are typically employed to find a minimum cost, not maximum. Moreover, “maxima” is the plural form of “maximum” yet is referred to as “a maxima….”
Based on Applicant’s disclosure and claim 26, Examiner is interpreting this portion of claim 25 as follows: “…the optimization method is based on an optimization problem searching for arguments that minimize maximum deflection error within a predefined search space for the defined position, the defined size and/or the defined external magnetic field, respectively.”
Claims 26-28 depend directly or indirectly from claim 25 and, as such, are also indefinite based upon their dependency.
Claims 25, 28, and 29 also recite the term “respectively” in a confusing manner. For example, claim 25 recites “[searching] within a predefined search space for the defined position, the defined size and/or the defined external magnetic field, respectively.” In the context of the claims, the term “respectively” typically means individually or separately. However, the claims also recite “and/or” in the list which implies that it is possible for them to not be considered individually, but as a group, which is consistent with the idea of optimizing a design that includes multiple variables.
Examiner is interpreting this language as if the term “respectively” was not recited.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims recite:
simulating a shape of the rod-shaped portion resulting when the at least one magnetic element located at a defined position at the rod-shaped portion having a defined size is subjected to a defined external magnetic field producing the external magnetic force using a FE model of the rod-shaped portion; (claim 18)
determining a difference between the simulated shape and an at least one desired shape of the rod-shaped portion, the rod-shaped portion having the at least one desired shape being configured to be inserted into the anatomical structure of the human being and/or the animal; (claim 18)
adapting the defined position, the defined size and/or the defined external magnetic field based on the determined difference using an optimization method; (claim 18)
wherein the simulating, the determining, and the adapting are carried out iteratively until the determined difference is below a defined threshold; (claim 18)
determining a geometric model of the anatomical structure of the human being and/or the animal and determining the at least one desired shape of the rod-shaped portion based on the determined geometric model; (claim 19)
the optimization method is based on a cost function mapping input parameters comprising the defined position, the defined size and/or the defined external magnetic field to the determined maximum deflection error; (claim 25)
the optimization method is based on an optimization problem searching for arguments of a maxima of the cost function within a predefined search space for the defined position, the defined size and/or the defined external magnetic field, respectively; (claim 25)
wherein the simulating, the determining and the adapting are carried out iteratively until the determined maximum deflection error is below a predefined threshold; (claim 26).
Claim limitation [a], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). The claim limitation is a mathematical concept because the claim limitation requires calculating mechanical forces and magnetic forces and explicitly recites “using an FE [Finite Element] model”.
Claim limitation [b], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). The claim limitation is a mathematical concept because the claim limitation requires calculating a difference (i.e., subtraction) between two shapes.
Claim limitations [c], as drafted and under their broadest reasonable interpretations, recites a mathematical concept and/or a mental process. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). The claim limitation is a mathematical concept because it explicitly recites “using an optimization method….” The claim limitation also recites a mental process because it can be performed in a human mind. (see MPEP § 2106.04(a)(2)(III)). Examples of mental processes include “observations, evaluations, judgments, and opinions.” (Id). In this case, adapting the defined position, the defined size and/or the defined external magnetic field based on the determined difference can be a human cognitive action.
Claim limitations [d] and [h], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). The claim limitation is a mathematical concept because the claim limitation requires comparing a value to a defined threshold.
Claim limitation [e], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). The claim limitation is a mathematical concept because determining a geometric model includes using image data to construct the model.
Claim limitation [f] and [g], as drafted and under its broadest reasonable interpretation, recites a mathematical concept. (MPEP 2106.04(a)(2)(I) (see, e.g., Digitech Image Techs., LLC v. Electronics for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (although the claims did not recite a particular mathematical formula, the court held “[w]ithout additional limitations, a process that employs mathematical algorithms to manipulate existing information to generate additional information is not patent eligible.”)). The claim limitation is a mathematical concept because a cost function is a mathematical algorithm.
This judicial exception is not integrated into a practical application. “A claim that integrates a judicial exception into a practical application will apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception.” (MPEP 2106.04(d)). Courts look to additional claimed elements/steps to determine whether the judicial exception is integrated into a practical application. In this case, the additional elements include:
(1) wherein the geometric model of the anatomical structure is determined based on a CT scan of the anatomical structure; (claim 20)
(2) further comprising determining the FE model of the rod-shaped portion based on dimensions and mechanical properties of the rod-shaped portion; (claim 21)
(3) further comprising outputting the defined position, the defined size and/or the defined external magnetic field when the determined difference is below a predefined threshold; (claim 22)
(4) further comprising manufacturing the rod-shaped portion of the medical device based on the output defined size and/or the output defined position; (claim 23)
(5) further comprising configuring a controller of another medical device configured to generate a magnetic field based on the output defined external magnetic field; (claim 24)
(6) wherein the method comprises determining the defined threshold based on dimensions of the rod-shaped portion, optionally based on a length of the rod-shaped portion, further optionally as a percentage of the length of the rod-shaped portion; (claim 27)
(7) further comprising determining the defined search space for the defined position, the defined size and/or the defined external magnetic field based on physical limitations of the rod-shaped portion, respectively; (claim 28);
(8) the defined size and/or the defined external magnetic field are kept constant, respectively, and/or a constant step size for adapting the defined position is used, respectively; (claim 29)
(9) wherein the rod-shaped portion of the medical device is a catheter configured to be inserted into a blood vessel of the human being and/or the animal; (claim 30).
These additional elements and/or steps do not meaningful limit the judicial exception, such that the claim is more than a drafting effort designed to monopolize the judicial exception. For example, the additional elements and/or steps do not improve the functioning of a computer or other technology or technical field. Many of the additional elements only clarify the data that is used in the calculations. Moreover, the additional elements and/or steps do not apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment (i.e., endoscopic procedures).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional elements and/or steps do not meaningfully limit the claim. As explained above, the additional elements and/or steps only limit the data that is considered (e.g., CT scan or dimensions and mechanical properties of the catheter) generally link the use of the judicial exception to a particular technological environment (i.e., endoscopic procedures, CT scan).
Accordingly, each of claims 18-31, as a whole, does not amount to significantly more than the judicial exception. Claims 18-31 are rejected under 35 U.S.C. 101 for lacking patent-eligible subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 18, 19, 21, 25-28, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd, Peter, et al. “Optimal design of soft continuum magnetic robots under follow-the-leader shape forming actuation.” 2020 International Symposium on Medical Robotics (ISMR). IEEE, 2020. (hereinafter LLOYD) and COMSOL, Optimization Module, v.5.4 (2018) (hereinafter COMSOL).
With respect to claim 18, LLOYD teaches a computer-implemented method configured for determining a design of a medical device comprising a rod-shaped portion configured to be inserted into an anatomical structure of a human being and/or an animal, wherein the rod-shaped portion includes at least one magnetic element configured and arranged to deform the rod-shaped portion using an external magnetic force acting on the at least one magnetic element. LLOYD teaches a process for optimizing the design of a magnetic soft tentacle for endoscopic procedures. (p.111, right column, last paragraph). In particular,
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”[s]tarting from a known anatomical pathway, we optimize the tentacle magnetization along its length in conjunction with the instantaneous controlling magnetic field to minimize contact forces during insertion.” (p.111, right column, last paragraph). Referring to Figure 1 above: “The aim in this case is to find the magnetization (µi) of the i-th link (Li) and the global homogeneous magnetic field (B) such that the magnetized tentacle conforms to a desired shape, minimizing contact with the environment. This is achieved through an optimization procedure…” (p.112, left column, 2nd paragraph of II. Problem Formulation).
NOTE: Regarding the simulating, determining, and adapting steps, LLOYD considers the magnetic tentacle (i.e., catheter) as a series of “multiple sections of magnetized elastomeric material operating under sequential insertion.” (p.111, bottom of right column to p.112, top of left column). LLOYD’s goal is to optimize the insertion process, which includes the tentacle getting progressively longer as the tentacle enters the patient’s lumen. “The insertion process is considered to be step-wise; for each insertion step (T) a new segment is introduced into the environment and its magnetization, along with the global homogeneous magnetic field B(k T), k = 0, 1, …, is optimized to produce the desired shape.” (p.112, left column, 2nd paragraph of II. Problem Formulation).
The computer-implemented method comprising:
simulating a shape of the rod-shaped portion resulting when the at least one magnetic element located at a defined position at the rod-shaped portion having a defined size is subjected to a defined external magnetic field producing the external magnetic force. “The aim in this case is to find the magnetization (µi) of the i-th link (Li) and the global homogeneous magnetic field (B) such that the magnetized tentacle conforms to a desired shape, minimizing contact with the environment. This is achieved through an optimization procedure…” (p.112, left column, 2nd paragraph of II. Problem Formulation). “To achieve suitable optimization, a model of the mechanical response of the tentacle as it interacts with its actuating magnetic field is required.” (p.112, left column, 4th paragraph of II. Problem Formulation). LLOYD applies a model that includes “the mechanical properties and magnetic properties and their interaction.” (p.112, left column, 1st paragraph of III. Magneto-Mechanical Design). Figure 2 of LLOYD illustrates how the step-wise process is performed as the tentacle is inserted and shows how the “Desired Position” may stray from the Rigid Link Model. Figure 2 also shows how the desired position strays from a Finite Element Analysis model (referred to as “FEA”).
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determining a difference between the simulated shape and an at least one desired shape of the rod-shaped portion, the rod-shaped portion having the at least one desired shape being configured to be inserted into the anatomical structure of the human being and/or the animal. LLOYD defines a “system of equations of the magneto-mechanical equilibrium….” (p.113, top of right column, C. Optimization) and then solves a “minimization problem…by using the Matlab function fmincon…” (p.113, middle of right column, C. Optimization).
adapting the defined position, the defined size and/or the defined external magnetic field based on the determined difference using an optimization method and wherein the simulating, the determining, and the adapting are carried out iteratively until the determined difference is below a defined threshold. LLOYD teaches adapting the defined external magnetic field based on the determined difference. “The algorithm described in Section III was applied to determine the case-specific magnetization (µi for the i-th segment) and the magnetic field at each time step (B).” (p.113, middle of right column). The fmincon function teaches the optimization method and performing the steps iteratively until the determined difference is below a threshold.
LLOYD does not explicitly teach using a FE model of the rod-shaped portion when performing the simulation during the iterative loop to optimize the design of the catheter. However, LLOYD specifically teaches using an FEA model to validate the rigid-link model. “In parallel to our rigid-link model (see Section III-A), a full continuum mechanics FEA model was constructed using the commercial software package COMSOL multiphysics v5.4 (COMSOL AB, Stockholm, Sweden). This simulation employed the solid mechanics and electro-magnetics modules connected via the Maxwell surface stress tensor.” (p.113, middle of right column).
LLOYD even acknowledges that the FEA model could be better for at least some scenarios. “From this we conclude that there remain inaccuracies in the assumptions of the rigid link model which are exposed by the FEA.” (p.116, right column, paragraph before Conclusions).
COMSOL is a document describing the optimization module of the FEA software implemented by LLOYD. “The Optimization Module can be used throughout the COMSOL product family — it provides a general interface for calculating optimal solutions to engineering problems. Any model inputs, be it geometric dimensions, part shapes, material properties, or material distribution, can be treated as control variables, and any model output can be an objective function.” (p.8, first paragraph). “The optimization problem is to find the value of the control variables that minimizes (or maximizes) the objective function, subject to a number of constraints. The constraints collectively define a set, the feasible set, of permissible values for the control variables.” (p.16, middle of page). The optimization includes determining difference between a simulated shape and a desired shape. “The parameter estimation problem is implemented as an optimization problem minimizing a sum of squared differences between model and reference data.” (p.72). Moreover, COMSOL teaches that the adapting is carried out iteratively until the determined difference is below a defined threshold. “The iterations are terminated either when the estimated error is less than the relative tolerance used by the current solver (convergence),….” (p.25).
It would have been obvious to one having ordinary skill in the art at the time of filing to modify the LLOYD optimization method by replacing the rigid-link model with an optimization method that uses FEA simulations. First, optimization using FEA is known by those having ordinary skill in the art and is effectively equivalent to the LLOYD method as demonstrated in LLOYD. Second, one would have been motivated to use FEA simulations, instead of the rigid link model, when designing the catheter, as LLOYD acknowledges that the rigid link model has inaccuracies in its assumptions. (see, e.g., p.116, right column, paragraph before Conclusions). There would have been a reasonable expectation of success as LLOYD demonstrates that FEA could simulate the shape of the tentacle (or catheter).
With respect to claim 19, LLOYD teaches determining a geometric model of the anatomical structure of the human being and/or the animal, and determining the at least one desired shape of the rod-shaped portion based on the determined geometric model. “We assume the lumen shape is known from pre-imaging for example, and that the optimal (desired) path from I to T has been ascertained by means of either a manual or an automated path planning algorithm (e.g. [21]).” (p.112, top of left column). See also p.111, bottom of right column: “Starting from a known anatomical pathway, we optimize the tentacle magnetization along its length in conjunction with the instantaneous controlling magnetic field to minimize contact forces during insertion.”
With respect to claim 21, the combination of LLOYD and COMSOL teaches determining the FE model of the rod-shaped portion based on dimensions and mechanical properties of the rod-shaped portion. LLOYD teaches generating a mechanical model and magnetic model that are derived from the tentacle and then solving a system of equations based on them. (p.112 beginning at Section III). “In the following section, the modeling approach applied to the magnetic tentacle shown in Fig. 1 is described; including the mechanical and magnetic properties and their interaction.” (Id). When replacing the rigid-link model with an optimization method that uses FEA simulations, as discussed above with respect to claim 18, one having ordinary skill in the art would base the FE model on dimensions and mechanical properties of the rod-shaped portion as described in LLOYD.
With respect to claim 25 (and in light of the Section 112 rejection), LLOYD does not explicitly teach the entirety of the claim language. LLOYD teaches determining the performance of a model based on deflection error. “Table I reports the Root Mean Square (RMS) of errors in deflection in the x axis between…the desired path and the rigid link model….” (p.116, middle of left column). Notably, the errors are based on the amount of deflection from predefined measurement points of the desired path and the rigid link model path. These predefined measurement points include the tip at each time step (row 1 in Table 1) and the center of each segment at every time step (row 2). The error in the centers “provides a suitable proxy for the error in the shape forming capability of the tentacle.” (p.116, bottom of left column). LLOYD also determines the absolute error in the final tip positions. (p.116, bottom of left column).
Accordingly, LLOYD teaches that the difference between the simulated shape and the at least one desired shape of the rod-shaped portion is represented by a determined maximum deflection error among predefined measurement points on the at least one desired shape and the simulated shape.
However, LLOYD does not teach the remainder of claim 25. Nevertheless, COMSOL teaches the optimization method is based on a cost function mapping input parameters comprising the defined position, the defined size and/or the defined external magnetic field to the determined maximum deflection error (see, e.g., p.64 in COMSOL: “The complete optimization problem can be set up directly…when the objective function to be minimized or maximized is a global scalar expression and the only control variables to be varied are already defined as model parameters.” (p.64, 2nd paragraph)), and the optimization method is based on an optimization problem searching for arguments of a maxima of the cost function within a predefined search space for the defined position, the defined size and/or the defined external magnetic field, respectively (the default is to perform a minimization of the objective function). (p.67, Type).
It would have been obvious to one having ordinary skill in the art at the time of filing to minimize the objective function of the maximum deflection error among measured points, wherein the objective function includes variables that determine how much the catheter is moved within a magnetic field (i.e., position and size of the magnetic elements), including the magnetic field. Notably, the magnetic field and the position and size of the magnetic elements are result-effective variables. (see MPEP 2144.05). One would have been motivated to optimize the design in order to reduce error in positioning the catheter during the surgery. There would have been a reasonable expectation of success as LLOYD and COMSOL teach that an objective function based on result-effective variables can be used to optimize the design of a catheter.
With respect to claim 26, as discussed above with respect to claim 19, the combination of LLOYD and COMSOL teaches wherein the simulating, the determining and the adapting are carried out iteratively until the determined maximum deflection error is below a predefined threshold. Optimization algorithms typically limit the number of iterations or define a threshold so that the algorithm does not operate indefinitely. For example, COMSOL teaches that iterations can be carried out until the difference is below a defined threshold. “The iterations are terminated either when the estimated error is less than the relative tolerance used by the current solver (convergence),….” (p.25). Moreover, the default in COMSOL is to minimize the objective function. (p.67, Type).
With respect to claim 27, the combination of LLOYD and COMSOL teaches wherein the method comprises determining the defined threshold based on dimensions of the rod-shaped portion, optionally based on a length of the rod-shaped portion, further optionally as a percentage of the length of the rod-shaped portion. NOTE: The “optionally” language of claim 27 makes it clear that any dimension of the rod-shaped portion could be used and any value (e.g., any percentage of the length) could be used.
It would have been obvious to one having ordinary skill in the art to base the defined threshold on a dimension of the rod-shaped portion. If the purpose of the method is to optimize the design of a medical device including a rod-shaped portion (i.e., the catheter (see [0039] of Applicant’s disclosure)), then it would be obvious to use a dimension of the rod-shaped portion when determining the defined threshold.
With respect to claim 28, the combination of LLOYD and COMSOL teaches further comprising determining the defined search space for the defined position, the defined size and/or the defined external magnetic field based on physical limitations of the rod-shaped portion.
It would have been obvious to one having ordinary skill in the art to determine the defined search space of a result-effective variable (i.e., defined position, defined size, or defined external magnetic field) based on the physical limitations of the rod-shaped portion. If the purpose of the method is to optimize the design of a medical device including a rod-shaped portion (i.e., the catheter (see [0039] of Applicant’s disclosure)), then it would be obvious to limit the search space to physically possible scenarios. (see, e.g., COMSOL: “The constraints collectively define a set, the feasible set, of permissible values for the control variables.” (p.16, middle of page).
With respect to claim 31, the combination of LLOYD and COMSOL teaches a non-transitory computer-readable medium, wherein the computer-readable medium comprises instructions which, when the instructions are executed by a computer, cause the computer to carry out the method according to claim 18. LLOYD teaches “[a]n autonomous routine, based on a combination of rigid link and magnetic modelling has been designed to optimize the length-wise magnetization profile or magnetic signature of the tentacle.” (p.111, bottom of right column). LLOYD suggests that it has “potential as a design tool….” (Abstract).
COMSOL teaches a software module that includes algorithms for optimizing parameters through iteration. (see, e.g., p.25: “The iterations are terminated either when the estimated error is less than the relative tolerance used by the current solver (convergence),….”). Moreover, COMSOL teaches that the software can be downloaded (i.e., onto a computer-readable medium).
It would have been obvious to one having ordinary skill in the art at the time of filing to store the instructions (or routine) on a non-transitory computer-readable medium that would execute the method of claim 18 by a processor. One would have been motivated to store the method as software or a program so that the method could be subsequently used to design catheters based on a patient’s anatomy.
Claims 20 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd, Peter, et al. “Optimal design of soft continuum magnetic robots under follow-the-leader shape forming actuation.” 2020 International Symposium on Medical Robotics (ISMR). IEEE, 2020. (hereinafter LLOYD) and COMSOL, Optimization Module, v.5.4 (2018) (hereinafter COMSOL) as applied to claim 18 above, and further in view of Attanasio, Aleks, et al. “Autonomy in surgical robotics.” Annual Review of Control, Robotics, and Autonomous Systems 4.1 (2021) (hereinafter ATTANASIO).
With respect to claim 20, neither LLOYD nor COMSONL explicitly describe that the geometric model of the anatomical structure is determined based on a CT scan of the anatomical structure. However, LLOYD specifically describes the “problem” as “guiding a soft tentacle through a lumen, from an insertion point (I) to the target point (T) as depicted in Fig. 1 .” (p.112, left column, II. Problem Formulation). Figure 1 refers to a generic lumen.
It is well known by those skilled in the art that CT imaging can be used as preoperative imaging to plan for a medical procedure starting at an insertion point to a target point. For example, ATTANASIO teaches that “preoperative analysis, such as MRI and computed tomography (CT), [can be used] to develop virtual reality for planning in neurosurgery or to minimize collisions in abdominal and thoracic surgery.” (p.659, Section 3.2.1). ATTANASIO further teaches that “[p]reoperative images (MRI, CT, and ultrasound) are used to extract the shape and location of the target, and 3D models are then registered to the anatomy. MRI- and CT-compatible fiducial markers can be adopted to address issues in registration.” (p.659, Section 3.2.2).
It would have been obvious to one having ordinary skill in the art at the time of filing to use CT scan data of the anatomical structure to determine a geometric model of the anatomical structure. One of ordinary skill in the art would have been motivated to use CT image data because LLOYD teaches generating a model of a lumen and ATTANSIO teaches that CT imaging can to develop a plan for the surgery. There would have been a reasonable expectation of success as ATTANASIO teaches that CT image data can be used to determine a geometric model of the anatomical structure.
With respect to claim 30, neither LLOYD nor COMSONL explicitly describe that the rod-shaped portion of the medical device is a catheter configured to be inserted into a blood vessel of the human being and/or the animal. However, LLOYD specifically describes the “problem” as “guiding a soft tentacle through a lumen, from an insertion point (I) to the target point (T) as depicted in Fig. 1 .” (p.112, left column, II. Problem Formulation). Figure 1 refers to a generic lumen.
It is well known by those skilled in the art that catheters can be inserted into a blood vessel of a human or animal. For example, ATTANASIO teaches that “[e]xamples of continuum surgical devices [i.e., catheters] include…cardiovascular catheters.” (p.667, 5.2 Navigation of Continuum Surgical Devices). “In the context of the autonomous navigation of cardiovascular catheters, Fagogenis et al. presented some advanced work that uses force sensing and palpation to drive an autonomous catheter through blood vessels and up to the heart.” (668, 5.2 Navigation of Continuum Surgical Devices).
It would have been obvious to one having ordinary skill in the art at the time of filing to design a rod-shaped portion of the medical device as a catheter that is configured to be inserted into a blood vessel of the human being and/or the animal. One of ordinary skill in the art would have been motivated to design a catheter that is configured to be inserted into a blood vessel as ATTANSIO teaches autonomously controlled catheters [e.g., magnetically-controlled catheters] can be used for cardiovascular applications. There would have been a reasonable expectation of success as LLOYD teaches that the tentacle can be inserted into a lumen and ATTANASIO teaches that autonomous catheters can be used for vascular applications.
Claims 22-24 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Lloyd, Peter, et al. “Optimal design of soft continuum magnetic robots under follow-the-leader shape forming actuation.” 2020 International Symposium on Medical Robotics (ISMR). IEEE, 2020. (hereinafter LLOYD) and COMSOL, Optimization Module, v.5.4 (2018) (hereinafter COMSOL) as applied to claim 18 above, and further in view of U.S. Patent Appl. Publ. No. 2023/0138992 A1 (hereinafter VALDASTRI).
With respect to claim 22, LLOYD and COMSOL do not explicitly teach the method further comprises outputting the defined position, the defined size and/or the defined external magnetic field when the determined difference is below a predefined threshold.
However, LLOYD describes a method for a “task-specific optimization of millimetre scale, magnetically actuated soft continuum robots for application in endoscopic procedures.” (Abstract). The goal of LLOYD is to develop a “design tool” (Abstract) that will “optimize the length-wise magnetization profile or magnetic signature of the tentacle.” (p.111, bottom of right column). As such, one having ordinary skill in the art would desire a method that outputs the define position or size of the magnetic elements. Likewise, the goal of COMSOL is to optimize design parameters. COMSOL also teaches that data can be exported. (p.50).
Moreover, in the same field of endeavor, VALDASTRI concerns magnetically-controlled “continuum manipulators,” which include catheters and endoscopes. (Abstract and [0002]). VALDASTRI notes that “[t]raditional continuum manipulators rely on body rigidity to transmit forces and torques from proximal to distal ends. This approach relies on operator skill, offers limited accuracy or dexterity and the process itself can cause tissue trauma.” VALDASTRI teaches that the limitations of traditional continuum manipulators may be mitigated by magnetically-actuated manipulators.
VALDASTRI teaches several techniques for manufacturing the magnetically-actuated continuum manipulators. (see, e.g., Figures 3A-3D and 4 and accompanying text), which typically involves positioning the magnetic elements and then molding an elastomer around the magnetic elements. ([0048]). Although VALDASTRI does not explicitly teach outputting parameters for manufacturing, VALDASTRI clearly teaches that continuum manipulators can be made to a particular design that is unique (i.e., optimized) for the surgery and/or patient. (see, e.g., [0066]: “The magnetic elements are magnetised, before clinical use, with a magnetic profile that can be actuated during clinical use in order to determine the shape of the CM. The CM may be designed to have a specific predetermined shape that can be ‘switched on’ by the external magnetic field when the CM has reached its destination” and [0067]: “Independent control of the magnetic elements enables the CM to adopt a shape along its length that can be selected for the specific clinical application and indeed the anatomical structures of a specific patient”; and [0049]: “Sequential alternate injection of elastomer and insertion of magnetic elements creates a CM with a desired distribution and spacing of magnetic elements 2 in an elastomeric base material 1” and [0055]: “The geometry of the magnetizing tray may be determined by the solution to the inverse static problem for the CM, the solution being generated by a neural network based on a predefined desired shape for the CM”; see also [0047]: “desired axial spacing”; [0054]: mold with “desired shape”).
It would have been obvious to one having ordinary skill in the art at the time of filing to output the design parameters (i.e., defined position of the magnetic elements, the defined size of the magnetic elements and/or the defined external magnetic field) after optimizing the design (i.e., in response to the determined difference being below a predefined threshold). One would have been motivated to output the design parameters so that the catheter could be manufactured according to the design parameters.
With respect to claim 23 (depending on claim 22), LLOYD and COMSOL do not explicitly teach the method further comprises manufacturing the rod-shaped portion of the medical device based on the output defined size and/or the output defined position.
As explained above with respect to claim 22, it would have been obvious to one having ordinary skill in the art at the time of filing to output the design parameters (i.e., defined position of the magnetic elements, the defined size of the magnetic elements and/or the defined external magnetic field) after optimizing the design (i.e., in response to the determined difference being below a predefined threshold). One would have been motivated to output the design parameters so that the catheter could be manufactured according to the design parameters.
With respect to claim 24 (depending on claim 22), LLOYD and COMSOL do not explicitly teach the method further comprises configuring a controller of another medical device configured to generate a magnetic field based on the output defined external magnetic field.
However, LLOYD teaches optimizing various parameters of the insertion process, which includes parameters of the catheter and parameters of the magnetic field. “The insertion process is considered to be step-wise; for each insertion step (T) a new segment is introduced into the environment and its magnetization, along with the global homogeneous magnetic field B(k T), k = 0, 1, …, is optimized to produce the desired shape.” (p.112, left column, 2nd paragraph of II. Problem Formulation). Accordingly, “[t]he aim in this case is to find the magnetization (µi) of the i-th link (Li) and the global homogeneous magnetic field (B) such that the magnetized tentacle conforms to a desired shape, minimizing contact with the environment. This is achieved through an optimization procedure…” (p.112, left column, 2nd paragraph of II. Problem Formulation). “To achieve suitable optimization, a model of the mechanical response of the tentacle as it interacts with its actuating magnetic field is required.” (p.112, left column, 4th paragraph of II. Problem Formulation).
As such, LLOYD clearly teaches that a magnetic field will be used to control the shape of the tentacle. However, LLOYD does not specifically teach the other medical device that generates an external magnetic field.
VALDASTRI teaches “dual arm control” of the continuum manipulator. (See Figure 5). “The external magnetic fields and magnetic field gradients can be provided by any one of a number of different techniques, for example: electromagnetic coils, MRI (magnetic resonance imaging) or multiple arm collaborative magnetic manipulation. Use of dual arm manipulation is schematically illustrated in FIG. 5 but more than two arms could be used.” ([0077]).
It would have been obvious to one having ordinary skill in the art at the time of filing to configure a controller of another medical device for generating a magnetic field based on the outputted defined external magnetic field. One of ordinary skill in the art would have been motivated to use a dual-arm device for providing the external magnetic field so that the continuum manipulator could be controlled as designed by the method in LLOYD. There would have been a reasonable expectation of success as both LLOYD and VALDASTRI teach that continuum manipulator (i.e., tentacles or catheters) can be magnetically controlled and VALDASTRI teaches systems that can provide such a magnetic field.
With respect to claim 29, LLOYD and COMSOL do not explicitly teach the method wherein: the defined size and/or the defined external magnetic field are kept constant, respectively, and/or a constant step size for adapting the defined position is used, respectively.
However, LLOYD does teach using a simulation in which the tentacle was constructed from a series of 14 mm segments where 7 mm of the segments were magnetic and the other 7 mm magnetically unreactive. (bottom of p.113 to top of p.114). To be clear, the simulated tentacle included evenly spaced magnetic elements of the same size.
Likewise, VALDASTRI teaches that the magnetic elements may have a constant size. (see, e.g., Figures 1, 3B, 3D, and Figure 4). For example, VALDASTRI teaches that “[o]nce cured, the doped elastomer was divided into three identical 7 mm segments 2 which were axially separated by 14 mm, still on the needle (FIG. 3B).” For an alternative method of manufacturing, VALDASTRI teaches that “[t]he doped elastomer magnetic segments 2 are prepared in the same way as described above in relation to FIGS. 3A and 3B and then removed from any supporting needle 3.” Thus, the different methods of manufacturing described with respect to Figures 3A-D and Figure 4 have a magnetic element of the same size. It is the different manner in which the elastomer portion of the catheter is provided that differentiates the embodiments.
While both LLOYD and VALDASTRI teach embodiments with magnetic elements of a constant size, COMSOL teaches that control variables may be activated or deactivated or have their limits modified. While discussing optimization features of the software, COMSOL teaches that the Optimization solver can be instructed to only evaluate the objective function for certain control variables. (p.66, 69). For example, control parameters may be removed, control variables may be deactivated, and constraints may be imposed on the optimum solution. (p.69). As such, one could make the size of the magnetic element constant when optimizing the design.
It would have been obvious to one having ordinary skill in the art at the time of filing to keep the defined size of the magnetic element constant while optimizing the design. One would have been motivated to optimize the design using a constant-sized magnetic element because using the same size eliminates one variable and, consequently, the number of computations necessary to perform the analysis, thereby reducing the time to optimize the design. Moreover, it would be desirable to manufacture differently-designed catheters that all have magnetic elements of the same size. Constant-sized magnetic elements would simplify manufacturing because only one size of the magnetic element would need to be repeatedly manufactured (e.g., using the same mold and/or processes). In fact, “fabrication simplicity” was the one factor that LLOYD described when discussing constraints. (p.113, middle of right column).
Prior Art Made of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. For example:
US-20200330730-A1 teaches a method for designing “patient-specific medical devices,” including catheters. ([0002] and [0007]).
Conclusion
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/JASON P GROSS/Examiner, Art Unit 3797 /SERKAN AKAR/ Primary Examiner, Art Unit 3797
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