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 .
Information Disclosure Statement
Information Disclosure Statements (IDS)s submitted on 12/18/2025 has been entered and fully considered by the examiner.
Claim Rejections - 35 USC § 102
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.
Claims 1-3, 7-13, and 17-20, are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Donoghue (“Electromagnetic tracking and steering for catheter navigation”, 2014) hereinafter “O’Donoghue”.
Regarding claim 1, O’Donoghue discloses a device [catheter device of Ueda; see page 62, section under 2.7.1. overview] comprising:
an insertable structure usable in a surgical theater; [catheter comprising a silicone rubber tube; see page 62, section under 2.7.2 and FIG. 2.24]
one or more permanent magnets positioned at respective locations in the insertable structure, each of the one or more permanent magnets having a magnetization axis; and [see FIG. 2.24; permanent magnet located at the tip of the catheter and page 62, section under 2.7.2]
one or more electromagnetic sensors, [position sensing coil; see FIG. 2.24 ] wherein at least a portion of each of the one or more electromagnetic sensors is wrapped around one of the one or more permanent magnets such that a coil axis of the respective electromagnetic sensor substantially aligns with the magnetization axis of the corresponding permanent magnet, [position sensing coil; see FIG. 2.24 ; both the axis of the coil and the magnet are along the main longitudinal axis of the lumen of the catheter]
wherein the device is movable according to two different external magnetic fields [see page 62, section under 2.7.1. disclosing that there are two different magnetic field sources one at 0-200Hz and other at 20-30KHz] controlled by a computer system [see FIG. 2.25; the PC interface controls the generation of magnetic fields; see also page 65, section under 2.7.4]
Regarding claim 2, O’Donoghue further discloses that the two different external magnetic fields are generated by at least one magnetic field generator, and the two different external magnetic fields comprise an alternating current (AC) magnetic field and a direct current (DC) magnetic field. fields [see page 62, section under 2.7.1. disclosing that there are two different magnetic field sources one at 0-200Hz (DC magnetic field since the frequency includes 0 Hz) and other at 20-30KHz (AC magnetic field)]
Regarding claim 3, O’Donoghue further discloses that the device is configured to be located by the computer system using the AC magnetic field, and the device is configured to have the movement initiated by the computer system according to the DC magnetic field. [see page 62, section under 2.7.1. discloses that the DC field (range including the 0 Hz) is used to operate the actuator and move the catheter wile the AC field (range of 20-30 KHz) is used for tracking)
Regarding claim 7, O’Donoghue further discloses that one of the one or more electromagnetic sensors has a solenoidal geometry that includes a plurality of windings that include one or more substantially orbital turns. [see page 63 of the document, FIG. 2.24 (b) showing a coil winding around the magnetic core]
Regarding claim 8, O’Donoghue further discloses that the device comprises a magnetic motor, and wherein at least one of the permanent magnets is located inside the magnetic motor. [the examiner notes that according to Merriam Webster dictionary, a motor is a device that changes electrical energy to mechanical energy; here, the combination of the magnet, coil and controller make up the motor since they cause movement of the distal tip of the device; see FIG. 2.25]
Regarding claim 9, O’Donoghue further discloses that one of the one or more permanent magnets oscillates around an oscillating axis, and wherein the coil axis of the electromagnetic sensor substantially aligns with the oscillating axis. [see page 63 of the document, FIG. 2.24 (a) showing a magnetic core at the distal tip of the catheter]
Regarding claim 10, O’Donoghue further discloses that each of the one or more permanent magnets generates a magnetic field with a magnitude smaller than a magnetic saturation magnitude. [see page 69, section 2.7.7 discloses that unlike other designs the disclosed system does not operate in saturation mode]
Regarding claim 11, O’Donoghue discloses a system [system of O’Donoghue; See Fig. 2.27] comprising: a device [catheter device of Ueda; see page 62, section under 2.7.1. overview], comprising:
an insertable structure usable in a surgical theater; [catheter comprising a silicone rubber tube; see page 62, section under 2.7.2 and FIG. 2.24]
one or more permanent magnets positioned at respective locations in the insertable structure, each of the one or more permanent magnets having a magnetization axis; and [see FIG. 2.24; permanent magnet located at the tip of the catheter and page 62, section under 2.7.2]
one or more electromagnetic sensors, [position sensing coil; see FIG. 2.24 ] wherein at least a portion of each of the one or more electromagnetic sensors is wrapped around one of the one or more permanent magnets such that a coil axis of the respective electromagnetic sensor substantially aligns with the magnetization axis of the corresponding permanent magnet, [position sensing coil; see FIG. 2.24 ; both the axis of the coil and the magnet are along the main longitudinal axis of the lumen of the catheter]
and a computer system comprising: a memory, and a processor [see FIG. 2.25; the PC interface controls the generation of magnetic fields; see also page 65, section under 2.7.4; it is inherent that a PC includes a memory and a processor] configured to generate a set of instructions that, once executed, control two different external magnetic fields for locating the device and initiating a movement of the device. [see page 62, section under 2.7.1. disclosing that there are two different magnetic field sources one at 0-200Hz and other at 20-30KHz
Regarding claim 12, O’Donoghue further discloses that he two different external magnetic fields are generated by at least one magnetic field generator, and the two different external magnetic fields comprise an alternating current (AC) magnetic field and a direct current (DC) magnetic field. [see page 62, section under 2.7.1. disclosing that there are two different magnetic field sources one at 0-200Hz (DC magnetic field since the frequency includes 0 Hz) and other at 20-30KHz (AC magnetic field)]
Regarding claim 13, O’Donoghue further discloses that the device is configured to be located by the computer system using the AC magnetic field, and the device is configured to have the movement initiated by the computer system according to the DC magnetic field. [see page 62, section under 2.7.1. discloses that the DC field (range including the 0 Hz) is used to operate the actuator and move the catheter wile the AC field (range of 20-30 KHz) is used for tracking)
Regarding claim 17, O’Donoghue further discloses that one of the one or more electromagnetic sensors has a solenoidal geometry that includes a plurality of windings that include one or more substantially orbital turns. [see page 63 of the document, FIG. 2.24 (b) showing a coil winding around the magnetic core]
Regarding claim 18, O’Donoghue further discloses that the device comprises a magnetic motor, and wherein at least one of the permanent magnets is located inside the magnetic motor. [the examiner notes that according to Merriam Webster dictionary, a motor is a device that changes electrical energy to mechanical energy; here, the combination of the magnet, coil and controller make up the motor since they cause movement of the distal tip of the device; see FIG. 2.25]
Regarding claim 19, O’Donoghue further discloses that one of the one or more permanent magnets oscillates around an oscillating axis, and wherein the coil axis of the electromagnetic sensor substantially aligns with the oscillating axis. [see page 63 of the document, FIG. 2.24 (a) showing a magnetic core at the distal tip of the catheter]
Regarding claim 20, O’Donoghue further discloses that each of the one or more permanent magnets generates a magnetic field with a magnitude smaller than a magnetic saturation magnitude. [see page 69, section 2.7.7 discloses that unlike other designs the disclosed system does not operate in saturation mode]
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Donoghue (“Electromagnetic tracking and steering for catheter navigation”, 2014) hereinafter “O’Donoghue” in view of Somogyi et al. (U.S. Publication No. 2003/0040671) hereinafter “Somogyi”.
Regarding claim 4, O’Donoghue discloses all the limitations of claim 1 [see rejection of claim 1]
O’Donoghue does not disclose that at least one of the one or more permanent magnets defines an internal channel.
Somogyi, directed towards an insertable device with a permanent magnet at the distal tip for tracking the device [see abstract of Somogyi] further discloses that least one of the one or more permanent magnets defines an internal channel. [see FiG. 2A and [0037]; the hollow magnet 220 is used to track the location of the device tip]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of O’Donoghue further such that least one of the one or more permanent magnets defines an internal channel according to the teachings of Somogyi in order to define an interior chamber allowing for passage of fluids or tools [see [0034] of Somogyi]
Regarding claim 14, O’Donoghue discloses all the limitations of claim 11 [see rejection of claim 11]
O’Donoghue does not disclose that at least one of the one or more permanent magnets defines an internal channel.
Somogyi, directed towards an insertable device with a permanent magnet at the distal tip for tracking the device [see abstract of Somogyi] further discloses that least one of the one or more permanent magnets defines an internal channel. [see FiG. 2A and [0037]; the hollow magnet 220 is used to track the location of the device tip]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of O’Donoghue further such that least one of the one or more permanent magnets defines an internal channel according to the teachings of Somogyi in order to define an interior chamber allowing for passage of fluids or tools [see [0034] of Somogyi]
Claims 5, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Donoghue (“Electromagnetic tracking and steering for catheter navigation”, 2014) hereinafter “O’Donoghue” in view of Somogyi et al. (U.S. Publication No. 2003/0040671) hereinafter “Somogyi” as applied to claim 4 and 14 above and further in view of Ueda et al. (U.S. Patent No. 5,681,260) hereinafter “Ueda”.
Regarding claim 5, O’Donoghue as modified by Somogyi discloses all the limitations of claim 4 [see rejection of claim 4]
O’Donoghue as modified by Somogyi does not disclose a fiber optic line extending through the insertable structure and passing through the internal channel.
Ueda, directed towards a movable and trackable insertable device [see abstract of Ueda] further discloses that a fiber optic line extending through the insertable structure and passing through the internal channel. [see FIG. 77 and column 11, lines 54-65 disclosing a light guide fiber 16 and an image guide fiber 25 in the lumen]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of O’Donoghue as modified by Somogyi further such that a fiber optic line extending through the insertable structure and passing through the internal channel according to the teachings of Ueda in order to image the body organ as part of the endoscope 71 [see column 11, lines 45-50]
Regarding claim 15, O’Donoghue as modified by Somogyi discloses all the limitations of claim 4 [see rejection of claim 4]
O’Donoghue as modified by Somogyi the device does not disclose the device further comprises a fiber optic line extending through the insertable structure and passing through the internal channel.
Ueda further discloses that a fiber optic line extending through the insertable structure and passing through the internal channel. [see FIG. 77 and column 11, lines 54-65 disclosing a light guide fiber 16 and an image guide fiber 25 in the lumen]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of O’Donoghue as modified by Somogyi further such that a fiber optic line extending through the insertable structure and passing through the internal channel according to the teachings of Ueda in order to image the body organ as part of the endoscope 71 [see column 11, lines 45-50]
Claims 6, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Donoghue (“Electromagnetic tracking and steering for catheter navigation”, 2014) hereinafter “O’Donoghue” in view of Somogyi et al. (U.S. Publication No. 2003/0040671) hereinafter “Somogyi” as applied to claim 4 and 14 above and further in view of Huynh et al. (U.S. Publication No., 2007/0232898) hereinafter “Huynh”.
Regarding claim 6, O’Donoghue as modified by Somogyi discloses all the limitations of claim 4 [see rejection of claim 4]
O’Donoghue as modified by Somogyi the device does not disclose the device further comprises a guidewire extending through the insertable structure and passing through the internal channel.
Huynh, directed towards location sensing of a catheter [see abstract of Huynh] further discloses that the device further comprises a guidewire extending through the insertable structure and passing through the internal channel. [see [0015] of Huynh]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of O’Donoghue as modified by Somogyi further such that the device further comprises a guidewire extending through the insertable structure and passing through the internal channel according to the teachings of Ueda in order to allow for insertion of various tools into the boy using the guidewire [see [0015] of Huynh]
Regarding claim 16, O’Donoghue as modified by Somogyi discloses all the limitations of claim 4 [see rejection of claim 4]
O’Donoghue as modified by Somogyi the device does not disclose the device further comprises a guidewire extending through the insertable structure and passing through the internal channel.
Ueda further discloses that the device further comprises a guidewire extending through the insertable structure and passing through the internal channel. [see [0015] of Huynh]
It would have been obvious to a person of ordinary skill level in the art at the time of the filing of the invention to modify the design of O’Donoghue as modified by Somogyi further such that the device further comprises a guidewire extending through the insertable structure and passing through the internal channel according to the teachings of Ueda in order to allow for insertion of various tools into the boy using the guidewire [see [0015] of Huynh]
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARJAN - SABOKTAKIN whose telephone number is (303)297-4278. The examiner can normally be reached M-F 9 am-5pm CT.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795