DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive.
Examiner upholds the use of Abbott to teach that the segmented tubular member has a pattern of voids that provide variable flexibility to the member. Paragraph [0045] of Abbott teaches that a series of slits in the body can increase flexibility. Not only would one having ordinary skill in the art understand that a segment of a tubular body without voids would have a different level of flexibility than a segment containing voids, but Abbott teaches that adding voids changes a body’s flexibility.
Regarding the amendment to the independent claims that the electromagnet generates a steering torque on the permanent magnet, Abbott has been applied to teach this limitation. Paragraph [0036] & Figure 1 of Abbott demonstrate that an external magnet can control the shape of the body via its permanent magnets. Although Abbott is directed towards generating undulatory movement, this is not relied upon in the rejection. Abbott is applied to teach that a tubular member can include permanent magnets, and that those permanent magnets can be controlled by an external magnet in order to change the shape of the member. Examiner asserts that one having ordinary skill in the art would understand that the teachings of Abbott can be applied to a variety of instruments, such as the catheter system of Hwang, and the language of the claims does not disqualify the combination of Abbott and Hwang.
Claim Objections
Claim 1 is objected to because of the following informalities: “configured to receive a distal end of a catheter the permanent magnet” should read –configured to receive a distal end of a catheter; the permanent magnet--.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3, 5-9, & 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott (US 2020/0100658) in view of Hwang (US 2022/0331534) and Shachar (US 2004/0019447).
Regarding claims 1 & 5, Abbott teaches an apparatus comprising:
a permanent magnet (permanent magnet 408a, [0047]);
a segmented tubular member (compliant body 406, [0047]) comprising a first end (Figure 2c), a second end (Figure 2c), and a pattern of voids (series of exterior transverse slits, [0045]) on a distal portion of the segmented tubular member configured such that the pattern of voids provides variable flexibility along a length of the segmented tubular member ([0045]), wherein:
the permanent magnet is coupled to the first end of the segmented tubular member (Figure 2c);
the second end of the segmented tubular member is configured to receive a distal end of a catheter (Figure 2c);
Per Figure 2c, compliant body 406 has a lumen; thus, it is configured to receive a catheter.
the permanent magnet and the segmented tubular member each have an outer diameter between 0.1 millimeters and 10 millimeters ([0038] & [0042], Figure 2c); and
an electromagnet (electromagnetic actuator device 702, [0056]); and
a controller (servo drive, [0056]), wherein the controller is configured to:
control an electrical current to the electromagnet ([0056]); and
control a magnetic forced exerted by the electromagnet on the permanent magnet ([0056]) to generate a steering torque on the permanent magnet that controls a direction of a distal portion of the distal end of the catheter ([0036] & Figure 1).
Controlling the electrical current comprises controlling the magnetic force.
However, Abbott fails to disclose a drive mechanism configured to engage the catheter inserted into the first end of the segmented tubular member.
Hwang teaches a drive mechanism (driving unit 2, [0030]) configured to engage a catheter (medical device 3, [0030]) inserted into the first end of the segmented tubular member (medical tube 14, [0062]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott to include a drive mechanism configured to engage a catheter inserted into the first end of the segmented tubular, as taught by Hwang. Automating the insertion process lessens the burden on the operator and allows for more precise positioning of the catheter. Additionally, using the segmented tubular member in conjunction with the catheter prevents any damage to the patient’s vasculature during the insertion.
However, Abbott in view of Hwang fail to disclose an imaging device configured to provide imaging data of the permanent magnet.
Shachar teaches an imaging device (guidance, control, and imaging (GCI) apparatus 501, [0071]) configured to provide imaging data of the permanent magnet (permanent magnets, [0142]) ([0088] & [0142]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott and Hwang to include an imaging device configured to provide imaging data of the permanent magnet, as taught by Shachar. This provides tracking capabilities to allow the user to navigate the catheter to the proper position.
Regarding claim 2, Abbott in view of Hwang teach the apparatus of claim 1, and Abbott further teaches that:
the permanent magnet is a first permanent magnet ([0047] & Figure 2c); and
the apparatus further comprises a second permanent magnet (permanent magnet 408b, [0047], Figure 2c) coupled to the segmented tubular member between the first end of the segmented tubular member and the second end of the segmented tubular member ([0047] & Figure 2c).
Regarding claim 3, Abbott in view of Hwang teach the apparatus of claim 2, and Abbott further teaches a third permanent magnet (permanent magnet 408c, [0047], Figure 2c) coupled to the segmented tubular member between the first end of the segmented tubular member and the second end of the segmented tubular member ([0047] & Figure 2c).
Regarding claim 6, Abbott in view of Hwang teach the apparatus of claim 1, and Abbott further teaches that the permanent magnet comprises a central channel (Figure 2c).
Regarding claim 7, Abbott in view of Hwang teach the apparatus of claim 1, and Abbott further teaches that the electromagnet comprises a pair of Helmholtz coils ([0056]).
Regarding claim 8, Abbott in view of Hwang teach the apparatus of claim 7, and Abbott further teaches that:
the pair of Helmholtz coils is a first pair of Helmholtz coils ([0056] & Figure 4b);
the electromagnet comprises a second pair of Helmholtz coils ([0056] & Figure 4b); and
the controller is configured to control a magnetic force exerted by the electromagnet on the permanent magnet in three-dimensional space ([0056]).
Regarding claim 9, Abbott in view of Hwang teach the apparatus of claim 8, and Abbott further teaches that the electromagnet comprises a third pair of Helmholtz coils ([0056] & Figure 4b).
Regarding claims 16-18, Abbott in view of Hwang and Shachar teach the apparatus of claim 1, and Shachar further teaches:
a magnetic sensor (magnetic field sensors, [0129]) configured to detect a position of the permanent magnet (permanent magnets, [0142]) ([0137] & [0142]);
wherein the magnetic sensor is configured as an array of sensors ([0129]) circumscribing the permanent magnet (Figure 13); and
wherein the sensor is coupled to the controller (microcontrollers 102x, 102y, and 102z, [0137]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott and Hwang to include: a magnetic sensor configured to detect a position of the permanent magnet; wherein the magnetic sensor is configured as an array of sensors circumscribing the permanent magnet; and wherein the sensor is coupled to the controller, as taught by Shachar. This allows the position of the catheter in the body to be ascertained, resulting in a more effective procedure.
Regarding claim 19, Abbott in view of Hwang and Shachar teach the apparatus of claim 1, and Shachar further teaches a visual display (monitor 325, [0088]) configured to display a position of the permanent magnet ([0088] & [0142]).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott and Hwang to include a visual display configured to display a position of the permanent magnet, as taught by Shachar. This allows the user to view the imaging data, aiding in the real-time navigation of the apparatus.
Claim 20 is rejected for similar reasons to claim 1.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Abbott in view of Hwang and Shachar, as applied to claim 1, above, in further view of Kim (US 2023/0320695).
Regarding claims 13-14, Abbott in view of Hwang and Shachar teach the apparatus of claim 1.
However, Abbott in view of Hwang and Shachar fail to disclose that the permanent magnet and the segmented tubular member each have an outer diameter between 0.1 millimeters and 4.0 millimeters.
Kim teaches that the permanent magnets (permanent magnets (142), [0050], Figure 4) and the segmented tubular member (catheter-type ultrasound endoscope (100), [0050], Figure 4) each have an outer diameter between 0.1 millimeters and 4.0 millimeters ([0060] & Figure 4).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott, Hwang, and Shachar such that the permanent magnets and the segmented tubular member each have an outer diameter between 0.1 millimeters and 4.0 millimeters, as taught by Kim. A smaller diameter allows more vessels and ducts to be accessed.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Abbott in view of Hwang and Shachar, as applied to claim 1, above, in further view of Schwartz (US 5,573,520).
Regarding claim 15, Abbott in view of Hwang and Shachar teach the apparatus of claim 1.
However, Abbott in view of Hwang and Shachar fail to disclose that the pattern of voids comprises a rectangular pattern of voids.
Schwartz teaches that the pattern of voids (tube 50, Column 9, Line 37) comprises a rectangular pattern of voids (Figure 9).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to have modified the apparatus of Abbott, Hwang, and Shachar such that the pattern of voids comprises a rectangular pattern of voids, as taught by Schwartz. Placing voids in the catheter increases its flexibility, giving it a greater range of motion when navigating it.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADAM KOLKIN whose telephone number is (571)272-5480. The examiner can normally be reached Monday-Friday 1:00PM-10:00PM EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (572)-270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ADAM D. KOLKIN/Examiner, Art Unit 3798
/KEITH RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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