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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. CH 00058/21, filed on 01/21/2021 and parent Application No. EP 21315129.3, filed on 07/26/2021.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/19/2023 and 09/18/2025 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description:
FIG. 13: Although the specification states “The forces acting on the medical device 85 are: Hydrodynamic for Fd, Gravitational force Fg, Adhesion force Fadh, Friction force Ff, Normal contact force on the surface Fn, magnetic force Fext and Force Fline exerted on the controlling line 70” [Page 31, Lines 7-16], this figure does not include the label Fn.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
[Page 3, Line 10]: As written it reads “The controlling line can help to the magnetic navigation”. However, the examiner believes “to” should be “with”.
[Page 7, Lines 28-32]: As written it reads “For fields generated by permanent magnets, the orientation may performed by moving the magnetic actuator, in particular by using orientation means having arms, joints, telescopes, wheels, gears, rails, and others and combinations thereof”. However, to be grammatically correct “be” should be between “may” and “performed”.
[Page 8, Lines 9-14]: As written it reads “In one embodiment according to the invention, the system is additionally or alternatively intended for treating or diagnosing a patient by using an, preferably implantable, medical device having a magnetic part of a shape, size and surface structure defining a movement component of the medical device when it is dragged by a bodily fluid”. However, to be grammatically correct, the underlined “an” should be “a”.
[Page 17, Lines 28-29]: As written it reads “For example RFID technology could be used to power the medical device”. However, this is the first indication of the acronym RFID, therefore the term should be spelled out to provide clarity.
[Page 20, Line 25]: As written it reads “Moving the medical in a direction […]”. However, the examiner believes the word “device” should be included after “medical” (underlined above).
[Page 21, Line 31-32]: As written it reads “FIG. 2a-2b: a third embodiment of a controlling line driver”. However, the specification does not recite a “second” embodiment. The examiner notes that the description of FIGS. 3a-3b should be updated to “third embodiment” and the description of FIGS. 4a-4b should be updated to “fourth embodiment”.
[Page 23, Line 24]: As written it reads “Bluetooth, wireless LAN […]”. However, this is the first indication of the term “LAN” in the specification, therefore, the term should be spelled out to provide clarity.
[Page 29, Lines 15-16]: As written it reads “a fluoroscope, PET scanner, CT scanner, MRI system, or any other imaging system known in the art”. However, this is the first indication of the terms “PET”, “CT” and “MRI” in the specification, therefore, the terms should be spelled out to provide clarity.
[Page 36, Lines 11-13]: As written it reads “Fig. 15c shows the medical device 85 of 15b wherein the controlling line 70’’ has been loosened such as to steer the medical 85 substantially as described in the specification when it states context of FIG. 13c”. However, the examiner believes that “Fig.” should be included before “15b”, “device” should be included between medical and 85 (underlined above) and “FIG. 13c” should be “FIG. 15c” (i.e. because there is no FIG. 13c).
Appropriate correction is required.
Claim Objections
Claims 1, 19, 20, 21, 23, 26, 28, and 33 are objected to because of the following informalities:
Regarding claim 1, as written is reads “an intravascular medical device […] wherein the magnetic actuator is adapted to generate a magnetic field at a location in order to pull the medical device, and wherein the controlling unit is adapted to balance at least three forces applied on the medical device”. The examiner believes “the medical device” is intended to be the same as the “intravascular medical device” recited earlier in the claim. To avoid potential antecedent basis issues, the examiner would recommend using the same term throughout the claim.
Regarding claims 19, 23, 26, and 28, as written the read “the medical device”. The examiner believes “the medical device” is intended to be the same as the “intravascular medical device” recited in the claim 18. However, to avoid potential antecedent basis issues, the examiner would recommend updating the claim language to use the same term throughout the claims.
Regarding claims 20 and 21, as written they read “The system according to claim 18, wherein the controlling unit is adapted to take into account a friction force induced by the controlling line with the blood vessel walls” (Claim 20) and “The system according to claim 18, wherein the controlling unit is adapted to balance the contact forces induced by the head section with the blood vessel walls” (Claim 21). The examiner respectfully notes that claim 18 on which these claims depend recites “a vascular network” not “blood vessel walls”. To avoid potential antecedent basis issues, the examiner would recommend updating the claim language to be consistent with that of the independent claim.
Regarding claim 33, as written it reads “operate at least one magnetic actuator to create at least one magnetic field at at least one pre-determined location”. However, the examiner believes “operate” should be “operating” since the other limitations involve “introducing”, “computing” and “adapting”.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) except as otherwise indicated in an Office action.
This application includes one or more claim limitations that uses the word “means,” and is being interpreted under 35 U.S.C. 112(f). Such claim limitation(s) is/are: “further comprising means for controlling and/or reducing blood flow in a vessel” in claim 31.
That being said, this means is described in the specification when it states “The system may preferably comprise means for controlling and/or reducing and/or increasing the blood flow in a vessel. Particularly preferably, a balloon attached to a delivery catheter and a separate catheter is used. It is also conceivable, however, to use an external device, for example a compression device” [Page 18, Lines 29-33], “It will be understood that the means for controlling and/or reducing blood flow may be attached or attachable to any part of the medical device and/or delivery catheter. Alternatively, the means may be configured as a separate device” [Page 19, Lines 6-9]. Therefore, the examiner will be interpreting the means for controlling and/or reducing blood flow in a vessel to be at least one of a balloon attached to a delivery catheter, or an external device (i.e. compression device).
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: controlling unit in claims 18-26, 30, and 32.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. That being said, the controlling unit is described in the specification when it states “Preferably, the controlling unit may comprise a processor and/or memory. In a particularly preferred embodiment, the controlling unit is in operable connection with an electric motor and is adapted to control at least one of speed, power, and torque of the electric motor” [Page 4, Liens 9-13], “Additionally or alternatively, the controlling unit may be adapted for receiving data from a sensor at or close to the device position, in particular data related to the magnetic field and/or force at the device position” [Page 5, Lines 5-8], and “The controlling unit may further be adapted to calculate and/or determine a force acting on the medical device through the controlling line. To this end, the controlling unit may comprise and/or be in operable connection with a force sensor adapted to measure a force acting on the medical device” [Page 5, Lines 25-29]. Therefore, the examiner is interpreting the controlling unit to be a processor configured to perform specific functions such as controlling an electric motor, receiving data from a sensor (i.e. related to magnetic field and/or force), calculating/determining a force acting on the medical device. Thus, in claims 18-26, 30 and 32 is not subject to further rejection under 35 U.S.C. 112(a)/112(b) with respect to the controlling unit.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f).
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.
Claims 33 and 34 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Regarding claim 33, as written it reads “adapting the releasing velocity of a controlling line attached to the medical device”. However, there is a lack of antecedent basis for the term “the releasing velocity”. Thus, it is unclear whether the method is intended to include a step of calculating an initial releasing velocity and/or what the releasing velocity is referring to within the method. The examiner recommends clarifying the meaning of the term “the releasing velocity” and/or amending the claim to avoid antecedent basis issues.
Regarding claim 34, due to its dependence on claim 33, this claim is also subject to rejection under 35 U.S.C. 112(b) for the reasons stated therein. Furthermore, this claim does not remedy the issues of claim 33 as it does not discuss “the releasing velocity”.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18, 22-26, 28-29, and 33-34 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Garibaldi et al. US 2004/0030244 “Garibaldi”.
Regarding claim 18, Garibaldi discloses “A system for moving, in a vascular network, an intravascular medical device including a magnetic part in a head section and a controlling line in a back section, the system comprising:” (“An apparatus for navigating a medical device through body lumens and cavities constructed in accordance with the principles of this invention is indicated generally as 20 in FIG. 1. The apparatus 20 includes a magnet system 22 for applying a magnetic field to the magnet-tipped distal end of a medical device such as catheter 24, to navigate the distal end of the catheter through a portion of the body” [0019]; “Using the joystick 38, the physician indicates the direction to orient the catheter” [0020]; “A catheter 24 adapted for use with the navigation method and apparatus of the present invention is shown in FIGS. 2 and 3. The catheter 24 has a proximal end 74 and a distal end 76. There is preferably at least one magnet 78 in the distal end of the catheter. This magnet 78 may either be a permanent magnet or a permeable magnet. The magnet 78 is of sufficient size to cause the distal end portion of the catheter to align with an applied magnetic field” [0039]. In order for the joystick 38 to be used to orient the catheter (see [0020]) a controlling line must be present between the joystick 38 and the catheter 24 to facilitate such movement. The apparatus is shown in FIG. 1. Therefore, Garibaldi discloses a system for moving, in a vascular network (i.e. body lumens and cavities), an intravascular medical device (i.e. catheter 24) including a magnetic part (i.e. magnet-tipped distal end/magnet 78) in a head section (i.e. distal end 76) and a controlling line (i.e. inherently present between joystick and proximal end 74 of catheter 24)) in a back section (i.e. proximal end 74).);
“a magnetic actuator” (“The magnet system 22 is preferably a set of electromagnetic coils that can be disposed around the body part to create a magnetic field within the body part of variable direction and intensity” [0019]. Therefore, since the magnet system 22 is used to create a magnetic field within the body, the magnet system 22 represents a magnetic actuator.);
“a controlling unit” (“The apparatus 20 also includes a computer 26 for controlling the magnet system 22 […] The computer 26 displays these images on displays 32 and 34. The computer 26 also displays interface information on the displays to facilitate inputting information about the desired path [0019]. Therefore, since the computer 26 controls the magnet and allows for input information about the desired path to be input, the computer 26, represents a controlling unit.);
“a controlling line driver” (“A controller 36, connected to the computer 26, has a joystick 38 and trigger or button 40 for the user to operate the apparatus 20” [0019]. Therefore, since the controller 36 has a joystick to operate the apparatus 20, the controller 36 represents a controlling line driver.);
“wherein the controlling line driver is adapted to hold and/or to release at different speeds the controlling line when the controlling line is attached to the controlling line driver” (“Generally, the apparatus of the present invention comprises a magnet system for applying a magnetic field to the magnet-tipped distal end of a medical device, to navigate, orient, and hold the distal end of the medical device in the body” [0005]; “In FIG. 5A, the user uses joystick 38 on the joystick controller 36 to manipulate marker 42 on display 32 over the point where the user wants to change the direction of the catheter and presses button 40 to lock the marker in place. In FIG. 5B, the user then uses the joystick 38 on the joystick controller 36 to manipulate marker 44 on the display 32 over a point on the desired new path of the catheter, and presses button 40 to lock the marker in place” [0028]. Therefore, since the apparatus is used to hold the distal end of the medical device in the body and the user utilizes joystick 38 to manipulate a marker (i.e. 42 or 44 in FIGS. 5A/5B) and presses button 40 to lock the marker in place (i.e. such that the catheter is then moved toward the marker), the controlling line driver is adapted to hold the controlling line when the controlling line is attached to the controlling line driver.);
“wherein the magnetic actuator is adapted to generate a magnetic field at a location in order to pull the medical device” (See magnet system 22 as discussed in paragraph [0019] above; “After selecting the orientation of the catheter, a button is pressed on the joystick controller 36 to initiate computer control of the magnet system 22. The computer 26 computes the required external magnetic field strength and/or direction to orient the catheter 24 as indicated on the displays 32 and 34. From this calculation, the computer 26 determines the power settings of each of the magnet coils within the magnet system 22. The computer 26 then programs digital-to-analog output modules to the determined settings to control each of the magnet power supplies in the magnet system 22. The composite field generated by each of the magnets within the magnet system 22 is equivalent to the predetermined field direction and strength for the current catheter tip location” [0025]; “The markers 42 and 48 and 44 and 52 identify unique points in three dimensional space in the body part. The computer 26 determines the direction of the line between these two points, and cause the magnet system 22 to generate a magnetic field in the same direction, which causes the magnet on the distal end of the catheter 24 to align the distal end of the catheter in the same direction” [0030]. Therefore, the magnetic actuator (i.e. magnet system 22) is adapted to generate a magnetic field at a location (i.e. corresponding to the selected orientation of the catheter (see [0025]) in order to pull the medical device (i.e. catheter 24 in the same direction as the magnetic field.).); and
“wherein the controlling unit is adapted to balance at least three forces applied on the medical device” (“The physician applies torque and axial push force on the proximal end of the medical device or guidewire to effect tip direction and axial advancement at the distal end” [0002]; “In the preferred embodiment the computer 26 controls the magnets to apply a magnetic field at a 90° over-torque, i.e., it leads the desired angle of deflection by 90°, in the same plane as the desired angle of deflection. This application of force normal to the desired orientation of the catheter 24 applies the maximum torque on the distal end of the catheter, and thus allows the minimum field intensity to be used” [0032]. Therefore, since the physician applies torque and axial push force to the proximal end or the medical device (i.e. catheter 24, for example) to advance the distal end and the computer 26 controls the magnets to apply a magnetic field at a 90° over-torque (i.e. force normal to the desired orientation of the catheter 24, the controlling unit must be adapted to balance at least three forces applied on the medical device (i.e. catheter).).
Regarding claim 22, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, and Garibaldi further teaches “wherein the system comprises at least two magnetic actuators and wherein the controlling unit is adapted to control the at least two magnetic actuators” (“The magnet system 22 is preferably a set of electromagnetic coils that can be disposed around the body part to create a magnetic field within the body part of variable direction and intensity. A suitable magnet system 22 is that disclosed in U.S. Pat. No. 4,869,247, issued Sep. 26, 1989, entitled Video Tumor Fighting System and U.S. Pat. No. 5,125,888, issued on Jun. 30, 1992, entitled Magnetic Stereotactic System for Treatment Delivery, the disclosures of which are incorporated herein by reference” [0019]. As shown in FIG. 8 of US Pat. No. 5,125,888, the device into which the patient’s head is inserted includes at least 5 superconducting coils 107 to generate a magnetic field (See [Abstract]: “An electromagnet is positioned outside of the body part for producing a magnetic field which captures the magnetic object”). Therefore, since a suitable magnet system 22 is disclosed in FIG. 8 of US Pat. No. 5,125,888, (i.e. and includes at least two magnetic actuators/supercoils 107), the magnet system 22 comprises at least two magnetic actuators and wherein the controlling unit is adapted to control the at least two magnetic actuators.).
Regarding claim 23, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, and Garibaldi further teaches “wherein the controlling unit has an interface for receiving intraoperative data from an imaging system, wherein the controlling unit is adapted to locate the position of the medical device” (“First and second imaging devices 28 and 30, connected to the computer 26, provide bi-planar images of the body part through which the catheter 24 is being navigated. The computer 26 displays these images on displays 32 and 34. The computer 26 also displays interface information on the displays to facilitate inputting information about the desired path” [0019] and “The imaging devices 28 and 30 are preferably x-ray fluoroscopes that provide real-time images of the body part through which the catheter 24 is being navigated. The imaging devices 28 and 30 are arranged so that each provides an image of the same portion of the body part, but at different orientations or planes” [0021]. These bi-planar images obtained from the imaging devices 28 and 30 are displayed on displays 32 and 34 as shown in FIGS. 5A-6F. Therefore, since the imaging devices 28 and 30 provide bi-planar images of the body part through which the catheter 24 is being navigated, the controlling unit has an interface for receiving intraoperative data (i.e. real-time images, see [0021]) from an imaging system (i.e. 28, 30), wherein the controlling unit is adapted to locate the position of the medical device (i.e. catheter 24 is shown within the images captured by the imaging devices 28, 30, see FIGS. 5A-6F).).
Regarding claim 24, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, and Garibaldi further teaches “wherein the controlling unit is adapted to compute the forces based on trajectory data that are representative for a predetermined vascular path” (See [0002] and [0032] as discussed with respect to claim 18. Therefore, in order for the computer 26 (i.e. controlling unit) to apply a magnetic field at a 90° over-torque, i.e., it leads the desired angle of deflection by 90°, it must have been adapted to compute the forces (i.e. over-torque, see [0032]; and torque and axial push force, see [0002]) based on trajectory data (i.e. corresponding to markers 42, 44, 48, 52, 54, 56, 58, 62, 66, 70 in FIGS. 5B-6F, respectively) that are representative for a predetermined vascular path (see FIGS. 5B-6F).
Regarding claim 25, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 24 above, and Garibaldi further teaches “wherein the controlling unit has an interface for the user to enter the trajectory data” (See [0019]; [0020] as discussed in claim 18 above and “The computer 26 provides a convenient user interface to facilitate the input of orientation information via the displays 32 and 34. More specifically, in the two point navigation system of the first preferred embodiment of the present invention, the user identifies the point where the user desires to change the direction of the catheter by manipulating a marker over this point on one of the displays with the joystick 38 of controller 36, and locking the marker in place by pressing one of the buttons 40 on the joystick controller. The user then identifies a point on the desired new path of the catheter 24 in the same manner, using the joystick 38 of controller 36 to manipulate a marker over this point on the display, and locking the marker in place by pressing one of the buttons 40 on the joystick controller” [0026]. Therefore, since the joystick 38 and buttons of controller 36 are connected to the computer 26 and provide a convenient user interface to facilitate the input of orientation information (i.e. trajectory data, see FIGS. 5B-6E), the controlling unit has an interface for the user to enter the trajectory data.).
Regarding claim 26, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, and Garibaldi further teaches “wherein the controlling unit is adapted to control the controlling line driver to slow down and/or to stop the displacement of the medical device when moving at least one magnetic actuator to a next position” (See [0028] and [0030] as discussed with respect to claim 18 above and “The markers 42 and 48 on screens 32 and 34, respectively, identify the point where the user desires to change the direction of the catheter, and preferably have similar size and shape to indicate to the user that they identify the same point” [0029]; “As shown in FIG. 6C, a third marker 58 appears, and the user uses joystick 38 to position this marker over a point on the desired new path of the catheter 24, and presses button 40 to lock the marker in position. The user then switches to the second display 34. In the preferred embodiment this is done by using the joystick 38 to manipulate the cursor on the display to the side of the display 32 adjacent the display 34, which causes the cursor to switch to display 34” [0031]; “The markers 54 and 62, 56 and 66, and 58 and 70 each define a unique point in the three dimensional space in the body part. The computer 26 calculates the angle formed by these three points, which is the desired angle of deflection, and then controls the magnet system 22 to apply a magnetic field of sufficient direction and intensity to cause the distal tip of the catheter to bend at this angle” [0032]. As shown in FIGS. 5B-5D, the marker 44 is placed in the left side of the bifurcation, the marker 44 indicating the direction which the catheter 24 should move toward when the magnetic field is produced by the magnet system 22. Likewise, FIGS. 6C-6F show marker 58 in the left side of the bifurcation, the marker 58 indicating the direction which the catheter 24 should move toward when the magnetic field is produced by the magnet system 22.
Therefore, markers 42, 44, 48, 52, 54, 56, 58, 62, 66, 70 (See FIGS. 5B-6F, respectively) are be placed to distinguish a desired path for the catheter 24 prior to activating the magnetic field by the magnet system 22 to cause deflection thereto. Thus, in order to perform this operation, the controlling unit must be adapted to control the controlling line driver to slow down and/or to stop (i.e. stop) the displacement of the medical device when moving at least one magnetic actuator to a next position (i.e. corresponding to the position of the markers 42, 44, 48, 52, 54, 56, 58, 62, 66, 70 in FIGS. 5B-6F).).
Regarding claim 28, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, and Garibaldi further teaches “wherein the controlling line driver comprises at least one interface to trigger and/or power at least one function of the medical device” (“A controller 36, connected to the computer 26, has a joystick 38 and trigger or button 40 for the user to operate the apparatus 20” [0019]; “The computer 26 computes the required external magnetic field strength and/or direction to orient the catheter 24 as indicated on the displays 32 and 34. From this calculation, the computer 26 determines the power settings of each of the magnet coils within the magnet system 22. The computer 26 then programs digital-to-analog output modules to the determined settings to control each of the magnet power supplies in the magnet system 22” [0025]. Therefore, since the controller 36 (i.e. controlling line driver) includes a button 40 for a user to operate the apparatus 20 and the computer 26 determines the power setting or each of the magnet coils within the magnet system 22, the controlling line driver comprises at least one interface (i.e. button 40) to trigger and/or power at least one function of the medical device (i.e. powering of the magnet coils within the magnet system 22).).
Regarding claim 29, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, and Garibaldi further teaches “wherein the controlling line driver and/or the controlling line is embedded into a sterile feature” (See [0020] as discussed with respect to claim 18 above and “In FIG. 8, catheter 24 has been navigated through blood vessel V, to the site of an aneurysm A” [0043]. In order for the joystick 38 to be used to orient the catheter (see [0020]) a controlling line must be present between the joystick 38 and the catheter 24 (i.e. proximal end 74) to facilitate such movement. To prevent cross-contamination, when inserting a catheter 24 through a patient’s body (i.e. blood vessel, for example), the catheter 24 must be sterile. Therefore, since the catheter 24 is navigated through blood vessel V, at least a portion of the controlling line (i.e. attached to the proximal end 74 of the catheter 24) must be embedded into a sterile feature.).
Regarding claim 33, Garibaldi teaches “A method of treating or diagnosing a patient, comprising the steps of:” (“The method and apparatus of the present invention facilitate the navigation of a magnet-tipped medical device through body lumens and cavities. Generally, the method of the present invention comprises: inputting information about the desired path of the medical device; determining the appropriate magnetic field direction and intensity to orient the distal end of the medical device in the direction of the desired path, and applying a magnetic field to the distal end of the medical device to orient the distal end in the direction of desired path” [0003]; “An application of the navigation method and apparatus of the present invention is illustrated in FIG. 8, where, as part of an interventional neuroradiology procedure, platinum coils 80 are inserted into an aneurysm to occlude the aneurysm. In the past problems have occurred due to randomness in the placement of the coils. The location where a coil 80 ends up depends upon the position of the tip of the catheter 24. In FIG. 8, catheter 24 has been navigated through blood vessel V, to the site of an aneurysm A” [0043]. Therefore, the method described in Garibaldi represents a method of treating (i.e. interventional neuroradiology procedure, see [0043]) or diagnosing a patient.);
“introducing a medical device in a vessel of a patient” (See [0003] and [0043] above. In order to orient the distal end (i.e. of catheter 24) in the direction of the desired path (i.e. see FIG. 5A/5B, for example) such that an aneurysm can be treated (see [0043]), the method must first introduce a medical device (i.e. catheter 24) in a vessel (i.e. blood vessel V, see FIG. 8) of a patient.);
“computing balanced forces applied on the medical device to create a resulting force able to move the medical device along a pre-determined path” (See [0003] above and [0002] and [0032] as discussed in claim 18 above. In this case, in order to determine the appropriate magnetic field direction and intensity to orient the distal end of the medical device in the direction of the desired path, the controlling unit (i.e. computer 26) must take into account the forces applied on the medical device (i.e. torque and axial push force, see [0002] and 90° over-torque, see [0032]) to create a resulting force able to move the medical device along a pre-determined path (i.e. toward an aneurysm, for example). Therefore, the method involves computing balanced forces applied on the medical device to create a resulting force able to move the medical device along a pre-determined path.);
“operate at least one magnetic actuator to create at least one magnetic field at at least one pre-determined location” (See [0003] above, and [0019], [0025] and [0030] as discussed with respect to claim 18 above. Since the method involves applying a magnetic field to the distal end of the medical device to orient the distal end in the direction of the desired path (i.e. corresponding to a pre-determined location), the method involves operating at least one magnetic actuator (i.e. magnetic system 22) to create at least one magnetic field at at least one pre-determined location.); and
“adapting the releasing velocity of a controlling line attached to the medical device” (“A limit on the angle of deflection can also be imposed to reduce the time necessary for the magnet system to operate, thereby speeding the navigation through the body” [0007]; “A controller 36, connected to the computer 26, has a joystick 38 and trigger or button 40 for the user to operate the apparatus 20” [0019]; “Additional controls can be provided, for example buttons 41 on controller 36, to refine the direction control of the medical device. […] These controls allow fine adjustment of the catheter orientation without the need to reposition the catheter tip using the two-point or three-point navigation system” [0027]. In this case, in order to avoid damaging anatomical structures unnecessarily, when refining the direction control of the medical device (i.e. catheter 24), the releasing velocity should be adapted such that the catheter does not mistakenly damage an undesired anatomical structure. Thus, since a limit on the angle of deflection can be imposed to reduce the time necessary for the magnet system (i.e. 22) to operate, thus speeding navigation through the body, and the controller 36 can include additional controls (i.e. as well as trigger or button 40) to refine the direction control of the medical device (i.e. catheter 24) (i.e. the releasing velocity being different/slower after utilizing the additional controls/button 40, for example), the method involves adapting the releasing velocity of a controlling line attached to the medical device.).
Regarding claim 34, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 33 above, and Garibaldi further teaches “comprising the further steps of stopping the medical device prior to a bifurcation” (See [0028] and [0030] as discussed with respect to claim 18 above and [0031] and [0032] as discussed in claim 26 above. As shown in FIGS. 5B-5D, the marker 44 is placed in the left side of the bifurcation, the marker 44 indicating the direction which the catheter 24 should move toward when the magnetic field is produced by the magnet system 22. Likewise, FIGS. 6C-6F show marker 58 in the left side of the bifurcation, the marker 58 indicating the direction which the catheter 24 should move toward when the magnetic field is produced by the magnet system 22. Therefore, the method further comprises the step of stopping the medical device prior to a bifurcation (i.e. such that markers 42, 44, 48, 52, 54, 56, 58, 62, 66, 70 can be placed to distinguish a desired path for the catheter 24 prior to activating the magnetic field by the magnet system 22 to cause deflection thereto.).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. US 2004/0030244 “Garibaldi” as applied to claim 18 above, and further in view of Ke Meng, "Motion Planning and Robust Control form the Endovascular Navigation of a Microrobot", (July 2020), IEEE Transactions on Industrial Informatics, Vol. 16, No. 7, pages 4557-4566.
Regarding claim 19, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above. Although Garibaldi discloses “The physician applies torque and axial push force on the proximal end of the medical device or guidewire to effect tip direction and axial advancement at the distal end” [0002] and “In the preferred embodiment the computer 26 controls the magnets to apply a magnetic field at a 90° over-torque, i.e., it leads the desired angle of deflection by 90°, in the same plane as the desired angle of deflection. This application of force normal to the desired orientation of the catheter 24 applies the maximum torque on the distal end of the catheter, and thus allows the minimum field intensity to be used” [0032] (i.e. 3 forces are detected: torque, axial push force, 90° over-torque corresponding to force normal to the desired orientation of the catheter 24.) Garibaldi does not teach “wherein the controlling unit is adapted to balance at least four forces applied on the medical device”.
Meng is within a related field of endeavor to the claimed invention because it involves endovascular navigation (see [Page 4557: Index Terms]).
Meng teaches “wherein the controlling unit is adapted to balance at least four forces applied on the medical device” (“When a microrobot is controlled to navigate in blood vessels, it is governed by several forces, including the external motive force (Fm), the blood hydrodynamic drag force (Fd), the contact force (Fc), the apparent weight force (Wg), and the van der Waals (Fv). […] Considering a spherical microrobot of mass m, the dynamic equation of the motion of the microrobot is expressed as follows mv = Fm + Fd + Fc + Wg + Fv, where v is the velocity of the microrobot. The calculation of each force is given in [16]” [Page 4559, Motion Control: Lines 1-12]. Therefore, the movement of the microrobot (i.e. medical device) is governed by external motive force (Fm), the blood hydrodynamic drag force (Fd), the contact force (Fc), the apparent weight force (Wg), and the van der Waals (Fv) (i.e. at least 4 forces, specifically 5). Thus, the controlling unit (i.e. controller, see FIG. 5 on Page 4560) which moves the microrobot (i.e. medical device) must be adapted to balance at least four forces applied on the medical device.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Garibaldi such that the controlling unit is adapted to balance at least four forces applied on the medical device as disclosed in Meng in order to provide more control over the movement of the medical device such that it avoids colliding with unintended anatomical structures. The act of balancing at least four forces applied on a medical device is one of a finite number of techniques which can be used to provide accurate control of the device with a reasonable expectation of success. Thus, modifying the system of Garibaldi such that the controlling unit is adapted to balance at least four forces applied on the medical device as disclosed in Meng would yield the predictable result of providing more control over the movement of the medical device such that it avoids colliding with unintended anatomical structures.
Regarding claim 20, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, however Garibaldi does not teach “wherein the controlling unit is adapted to take into account a friction force induced by the controlling line with the blood vessel walls”.
Meng teaches “wherein the controlling unit is adapted to take into account a friction force induced by the controlling line with the blood vessel walls” (See [Page 4559, Motion Control: Lines 1-12] as discussed with respect to claim 19 above. In this case, the blood hydrodynamic drag force represents a form of friction force (i.e. drag being synonymous with friction). Therefore, since one of the forces which governs the movement of the microrobot (i.e. medical device) is the blood hydrodynamic drag force, the controlling unit (i.e. controller, see FIG. 5 on Page 4560) must be adapted to take into account a friction force induced by the controlling line (i.e. attached to the medical device) with the blood vessel walls.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Garibaldi such that the controlling unit is adapted to take into account a friction force (i.e. blood hydrodynamic drag force) induced by the controlling line with the blood vessel walls as disclosed in Meng in order to provide more control over the movement of the medical device such that it avoids puncturing unintended anatomical structures (i.e. such as blood vessel walls). The act of accounting for a friction force induced by the controlling line (i.e. of a medical device) with the blood vessel wall is one of a finite number of techniques which can be used to provide accurate control of the device with a reasonable expectation of success. Thus, modifying the system of Garibaldi such that the controlling unit is adapted to take into account a friction force (i.e. blood hydrodynamic drag force) induced by the controlling line with the blood vessel walls as disclosed in Meng would yield the predictable result of providing more control over the movement of the medical device such that it avoids puncturing unintended anatomical structures (i.e. such as blood vessel walls).
Regarding claim 21, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, however Garibaldi does not teach “wherein the controlling unit is adapted to balance the contact forces induced by the head section with the blood vessel walls”.
Meng teaches “wherein the controlling unit is adapted to balance the contact forces induced by the head section with the blood vessel walls” (See [Page 4559, Motion Control: Lines 1-12] as discussed with respect to claim 19 above. Therefore, since one of the forces which governs the motion of the microrobot (i.e. medical device) is the contact force (Fc), the controlling unit (i.e. controller, see FIG. 5 on Page 4560) must be adapted to balance the contact forces induced by the head section (i.e. front/tip) with the blood vessel walls.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Garibaldi such that the controlling unit is adapted to balance the contact forces induced by the head section with the blood vessel walls as disclosed in Meng in order to provide more control over the movement of the medical device such that it avoids colliding or puncturing unintended anatomical structures. The act of balancing the contact forces induced by the head section (i.e. front/tip) with the blood vessel walls on a medical device is one of a finite number of techniques which can be used to provide accurate control of the device with a reasonable expectation of success. Thus, modifying the system of Garibaldi such that the controlling unit is adapted to balance the contact forces induced by the head section with the blood vessel walls as disclosed in Meng would yield the predictable result of providing more control over the movement of the medical device such that it avoids colliding or puncturing unintended anatomical structures.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. US 2004/0030244 “Garibaldi” as applied to claim 18 above, and further in view of Toth et al. US 2020/0342985 A1 “Toth”.
Regarding claim 27, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, however Garibaldi does not teach “wherein the controlling line driver comprises a force sensor”.
Toth is within a related field of endeavor to the claimed invention because it involves diagnostic catheters with sensors (see [0003] and [0036]).
Toth teaches “wherein the controlling line driver comprises a force sensor” (“In some embodiments, the medical device comprises a catheter device comprising a catheter body, at least one sensing tip disposed at a distal end of the catheter body, and a torquer element disposed at proximal end of the catheter body, the sensors and the processing modules are integrated with the at least one sensing tip at the distal end of the catheter body, the control system is integrated with the torquer element, and the wire bundle extends through the catheter body” [0029]; “In some non-limiting examples, one or more of the sensing tips or sensors may include one or more electrodes, a needle electrode, a force sensor, mechanomyographic (MMG) sensing element, a vibration sensor, a strain sensor, a pressure sensor, a compliance sensor, a temperature sensor, combinations thereof, or the like each in accordance with the present disclosure” [0088]. Therefore, since the catheter includes at least one sensing tip disposed at a distal end, the sensors and processing modules (i.e. controlling line driver) are integrated with the at least one sensing tip and the at least one sensing tip may include a force sensor, the controlling line driver comprises a force sensor.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Garibaldi such that the controlling line driver comprises a force sensor as disclosed in Toth in order to effectively compute/measure the force being exerted by the catheter as it travels through a patient’s body such that adjustments can be made if necessary. Incorporating a force sensor into a device is one of a finite number of techniques which can be used to calculate the force(s) being applied by the device with a reasonable expectation of success. Thus, modifying the system of Garibaldi such that the controlling line driver comprises a force sensor as disclosed in Toth would yield the predictable result of effectively computing/measuring the force(s) applied by the catheter (i.e. medical device) such that they can be received by the controlling line driver and used to control the movement of the catheter (i.e. medical device).
Claim(s) 30 and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. US 2004/0030244 “Garibaldi” as applied to claim 18 above, and further in view of Pancaldi et al. WO 2021/009615 A1 “Pancaldi” (International filing date: 07/07/2020).
Regarding claim 30, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, however, Garibaldi does not teach “comprising multiple controlling line drivers, wherein the controlling unit is adapted to operate the magnetic actuator and the multiple controlling line drivers to control the navigation of multiple medical devices”.
Pancaldi is within the same field of endeavor as the claimed invention because it involves a catheter with a distal end which is subjected to an external magnetic field (See [Abstract]).
Pancaldi teaches “comprising multiple controlling line drivers, wherein the controlling unit is adapted to operate the magnetic actuator and the multiple controlling line drivers to control the navigation of multiple medical devices” (“Upon application of the magnetic field, B, the torque exerted on the head rotates the head and bends the filament leading to an increase in both lift and drag forces” [0038], “In additional or alternative embodiments according to the invention, the device comprises electrically conductive tracks 400 (Figure 3). Typically, in one set of embodiments, said conductive tracks 400 act as interconnects between a subject’s tissue and further electrical and/or electronic devices such as for instance electrical stimulators, PCBs, microchips, connectors, wires and the like. […] Additionally or alternatively, conductive tracks 400 electrically connect two or more electrical or electronical devices between them, typically located at two different positions along the flow directed device: as a way of example, conductive tracks 400 can electrically join one or more proximally-located devices such as power supplies 500 with sensors 900 such as temperature sensors, velocity sensors, pressure sensors and the like distally located along the flow directed device (Figure 4)” [0081].
As shown in FIG. 4, the elongate body of the catheter includes two conductive tracks 400 which supply power (i.e. from the power supplies 500/controlling line drivers) to sensor 900 located at the end thereof. Therefore, the system comprises multiple controlling line drivers (i.e. conductive tracks 400), wherein the controlling unit (i.e. power supplies 500) is adapted to operate the magnetic actuator (i.e. which applies the magnetic field, see [0038]) and the multiple controlling line drivers (i.e. conductive tracks 400) to control the navigation of multiple medical devices (i.e. sensors 900 attached to the conductive tracks 400, see FIG. 4).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Garibaldi such that it comprises multiple controlling line drivers, wherein the controlling unit is adapted to operate the magnetic actuator and the multiple controlling line drivers as disclosed in Pancaldi in order to allow for the positioning of multiple medical devices within a single catheter such that multiple processes can be carried out within a patient. When multiple controlling lines are connected to multiple medical devices included within a catheter, multiple different functions can be carried out by the catheter, when it is positioned relative to a target region within a patient, with a reasonable expectation of success. Thus, modifying the system of Garibaldi such that it comprises multiple controlling line drivers, wherein the controlling unit is adapted to operate the magnetic actuator and the multiple controlling line drivers as disclosed in Pancaldi would yield the predictable result of enabling multiple devices to be used within a catheter at a target site within a patient.
Regarding claim 32, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, however, Garibaldi does not teach “comprising at least two controlling line drivers wherein the controlling unit is adapted to independently control the at least two controlling line drivers”.
Pancaldi teaches “comprising at least two controlling line drivers wherein the controlling unit is adapted to independently control the at least two controlling line drivers” (See [0081] as discussed with respect to claim 30 above. As shown in FIG. 4, the catheter includes two controlling line drivers (i.e. conductive tracks 400). Each of these conductive tracks 400 is controlled by the power supplies 500, to operate respective sensors 900, (i.e. such as temperature, velocity, pressure sensors and the like). Therefore, the system comprises at least two controlling line drivers (i.e. conductive tracks 400) wherein the controlling unit (i.e. power supplies 500) is adapted to independently control (i.e. to carry out measurements by sensors 900) the at least two controlling line drivers (i.e. 400).).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Garibaldi such that it comprises at least two controlling line drivers wherein the controlling unit is adapted to independently control the at least two controlling line drivers as disclosed in Pancaldi in order to allow for the positioning of multiple medical devices within a single catheter such that multiple processes can be carried out within a patient. When multiple controlling lines are connected to multiple medical devices included within a catheter, multiple different functions can be carried out by the catheter, when it is positioned relative to a target region within a patient, with a reasonable expectation of success. Thus, modifying the system of Garibaldi such that it comprises at least two controlling line drivers wherein the controlling unit is adapted to independently control the at least two controlling line drivers as disclosed in Pancaldi would yield the predictable result of enabling multiple devices to be used within a catheter at a target site within a patient.
Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garibaldi et al. US 2004/0030244 “Garibaldi” as applied to claim 18 above, and further in view of Schwartz et al. US 2017/0189654 A1 “Schwartz”.
Regarding claim 31, Garibaldi discloses all features of the claimed invention as discussed with respect to claim 18 above, however Garibaldi does not teach “further comprising means for controlling and/or reducing blood flow in a vessel”.
Schwartz is within a related field of endeavor to the claimed invention because it involves a system with a catheter and balloon (see [0096], FIG. 1).
Schwartz teaches “further comprising means for controlling and/or reducing blood flow in a vessel” (“Referring now to the figures, and first to FIG. 1, there is shown an embodiment of a system 10 of the invention. The system 10 generally includes a catheter 20 with an occlusion balloon 22 near a distal end 24 of the catheter 20. The occlusion balloon 22 may be spaced apart from the distal end 24 enough to provide space for components occurring in some embodiments of the system 10 such as side flow holes 26 and/or a distal pressure sensor 28.” [0096], “The occluding balloon 22 is inflated, and one or more physiologic flow rates are infused while measuring the pressure drop across the two transducers 100, 102” [0107]. The inflation of the occlusion balloon 22 causes blood flow in a vessel to decrease. Therefore, in this case, the occlusion balloon 22 represents a means for controlling and/or reducing blood flow in a vessel.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Garibaldi such that it includes a means for controlling and/or reducing blood flow in a vessel (i.e. an occlusion balloon 22) as disclosed in Schwartz in order to effectively control the amount of blood traveling through a blood vessel when a procedure is performed. An occlusion balloon is one of a finite number of structures which can be included on a catheter to reduce blood flow within a blood vessel with a reasonable expectation of success. Thus, modifying the system of Garibaldi such that it includes a means for controlling and/or reducing blood flow in a vessel (i.e. an occlusion balloon 22) as disclosed in Schwartz would yield the predictable result of controlling the amount of blood traveling through a blood vessel when a procedure is being performed.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Howard et al. US 5,125,888 A “Howard” is pertinent to the applicant’s disclosure because it discloses “FIG. 8 illustrates another off-axis view of the superconducting coils positioned around the patient's head without the cryostat being depicted” [Column 4, Lines 9-11].
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/KAITLYN E SEBASTIAN/Examiner, Art Unit 3797