DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment of 04/22/2026 has been entered and fully considered by the examiner. Claims 1, 4, 7-11, 14, 17, 19 and 20 have been amended. Claim 21 has been added. Claims 1-21 are currently pending in the application with claims 1 and 11 being independent.
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 1-3, 7-13, and 17-21 are rejected under 35 U.S.C. 103 as being obvious over 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 permanent magnet positioned at respective locations in the insertable structure, the one or more permanent magnet 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 electromagnetic sensor, [position sensing coil; see FIG. 2.24 ] wherein at least a portion of the one electromagnetic sensors is wrapped around the one permanent magnet 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 one of 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]
O’Donoghue discloses the claimed invention except for the number of electromagnetic permanent magnets and electromagnetic sensors wherein O’Donoghue discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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 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]
O’Donoghue discloses the claimed invention except for the number of electromagnetic permanent magnets and electromagnetic sensors wherein O’Donoghue discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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]
O’Donoghue discloses the claimed invention except for the number of electromagnetic permanent magnets and electromagnetic sensors wherein O’Donoghue discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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 that corresponds to the permanent magnet 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 permanent magnets positioned at respective locations in the insertable structure, each of the one 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 electromagnetic sensor, [position sensing coil; see FIG. 2.24 ] wherein at least a portion of each of the one electromagnetic sensor 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
O’Donoghue discloses the claimed invention except for the number of electromagnetic permanent magnets and electromagnetic sensors wherein O’Donoghue discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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 electromagnetic sensor 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]
O’Donoghue discloses the claimed invention except for the number of electromagnetic permanent magnets and electromagnetic sensors wherein O’Donoghue discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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 that corresponds to the permanent magnet 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 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]
O’Donoghue discloses the claimed invention except for the number of electromagnetic permanent magnets and electromagnetic sensors wherein O’Donoghue discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 21, O’Donoghue further discloses that the two or more permanent magnets are arranged sequentially in the insertable structure. [see FIG. 2.24 on page 30 of O’Donoghue; the permanent magnet insert is made up of two permanent magnets placed back to back (i.e. arranged sequentially) in the coil to make up the magnetic core; the examiner further notes that any permanent magnet could be made up of a number of permanent magnets sequentially placed back to back]
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 re 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]
O’Donoghue as modified by Somogyi discloses the claimed invention except for the number of permanent magnets and electromagnetic sensors wherein O’Donoghue as modified by Somogyi discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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 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]
O’Donoghue as modified by Somogyi discloses the claimed invention except for the number of permanent magnets and electromagnetic sensors wherein O’Donoghue as modified by Somogyi discloses one electromagnetic sensor comprises of one permanent magnet and the claim requires two or more electromagnetic sensors with two or more permanent magnets. 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 change the number of permanent magnets and electromagnetic sensor to be equal to two or more since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
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]
Response to Arguments
Applicant's arguments filed 04/22/2026 have been fully considered but they are not persuasive.
With regards to the added amendment to the claims, the applicant has argued that none of the references discloses two or more of the sensors made up of permanent magnets, and O’Donoghue only discloses one such sensor.
In response, the examiner notes that it has been long held that duplication of a structural element is not innovative and would have been obvious to a person or ordinarily skilled in the art as it has been detailed in the rejection section above. The applicant is advised to use more specific language regarding arrangement of the plurality of sensors beyond their number to distinguish their claims from the prior art of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Carey can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARJAN SABOKTAKIN/Examiner, Art Unit 3797
/MICHAEL J CAREY/Supervisory Patent Examiner, Art Unit 3795
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