DETAILED ACTION
This office action is in response to the communication received on July 22, 2026 concerning application No. 19/190,497 filed on April 25, 2025.
Claims 1-2 and 4-19 are currently pending.
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 07/22/2026 regarding the claim objections have been fully considered. The amendments to the claims have been entered and overcome the claim objections of claims 1, 8-10, 12, 14-15, and 18 previously set forth.
Applicant's arguments filed 07/22/2026 regarding the claim interpretation have been fully considered. The amendments to the claims have been entered and overcome the claim interpretation previously set forth.
Applicant's arguments filed 07/22/2026 regarding the 35 USC 112 rejection have been fully considered. The amendments to the claims have been entered and overcome the 35 USC 112 rejection of claims 11 and 15 previously set forth.
Applicant's arguments filed 07/22/2026 regarding the prior art rejection have been fully considered but they are not persuasive. In response to the applicant’s arguments that the prior art fails to teach “a magnetic sensor configured to detect a magnetic field of a transmitter disposed outside the ultrasonic probe, the magnetic sensor comprising a solenoid disposed at a position at least partially surrounded by the inner housing and having a first pole and a second pole”, examiner respectfully disagrees. Applicant specifically argues the prior art of record does not teach the limitation because the prior art of record does not disclose the magnetic sensor comprises a solenoid. However, as set forth in the previous office action [0028] of Buckley discloses the tracking element includes a field sensor and a field generator. Claim 11 further discloses “the tracking element comprises at least one of a magnetic field sensor or a magnetic field generator”, meaning the tracking element can comprise both the sensor and generator simultaneously. Hyun which was previously relied upon for the rejection of claims 5-6 is being relied upon to teach the deficiencies of Buckley. Specifically, [0044] of Hyun teaches the location sensor (magnetic sensor) comprises a solenoid. For at least these reasons the combination of Buckley in view of Hyun teaches the argued limitation recited above.
Applicant’s arguments with respect to claim(s) 18-19 regarding the newly filed claim amendment “wherein the ultrasonic transducer is attached to a distal end of the metal inner housing and is aligned to transmit ultrasonic energy distally away from the metal inner housing” have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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) 1-2, 4-6, 8-9, 12, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable by Buckley et al. (US 20120046553, hereinafter Buckley) in view of Hyun et al. (US 20130263668, hereinafter Hyun).
Regarding claim 1, Buckley teaches an ultrasonic probe (the system shown in fig. 2 which includes an ultrasound imaging device), comprising:
an ultrasonic transducer ([0024] transducer array 50 in fig. 2);
a metal inner housing that is thermally connected to the ultrasonic transducer ([0025] the catheter housing is composed of a metal layer 14. By surrounding the transducer 50 as shown in fig. 2, the metal layer 14 dissipates thermal heat from the transducer and is therefore thermally connected); and
a magnetic sensor configured to detect a magnetic field of a transmitter disposed outside the ultrasonic probe ([0028]-[0029] and claim 11 discloses the tracking element 20 comprises a magnetic field sensor for tracking the position of the device. [0001] discloses positioning systems use EM (electromagnetic) fields, therefore the magnetic field sensor of the tracking system is configured to detect EM field generated outside the ultrasonic probe in order to determine the tracking position), the magnetic sensor comprising a generator disposed at a position at least partially surrounded by the inner housing and having a first pole and a second pole ([0028]-[0029] discloses the tracking element 20 comprises a field sensor/generator made of coils which have a north and south pole when generating the field. Claim 11 further discloses the field sensor/generator is a magnetic field generator. Fig. 2 shows the tracking element 20 is surrounded by the metal layer 14. Further, claim 11 discloses the tracking element comprises at least one of a magnetic field sensor or a magnetic field generator, meaning the tracking element can comprise both the sensor and generator), wherein
the metal inner housing comprises a magnetic flux line-passing structure that allows passage of magnetic flux lines from the first pole back to the second pole ([0035] discloses the metal housing includes an acoustic window (passing structure) that allows passage of magnetic flux lines between the poles), the magnetic flux line-passing structure includes any one or more of a slit, a window, and a non-metal material ([0035] discloses the flux line-passing structure includes at least a window).
Buckley does not specifically teach the magnetic sensor comprises a solenoid as the generator.
However,
Hyun in a similar field of endeavor teaches the magnetic sensor comprises a solenoid ([0044] discloses the locations sensor (magnetic sensor) is formed of a solenoid).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the generator of Buckley for the solenoid of Hyun because it amounts to simple substitution of one known element for another to obtain the predictable results of generating a magnetic flux.
Regarding claim 2, Buckley in view of Hyun teaches the probe of claim 1, as set forth above. Buckley further teaches the magnetic flux line-passing structure has a position and size that allows passage of a detectable amount of magnetic flux through the magnetic field of the transmitter ([0028]-[0029] and [0035] by being able to track the position of the probe, the passing structure allows passage of a detectable amount of magnetic flux to the magnetic sensor).
Regarding claim 4, Buckley in view of Hyun teaches the probe of claim 2, as set forth above. Buckley further teaches the magnetic sensor detects a position and/or an orientation of the ultrasonic probe ([0028]-[0029] discloses the magnetic sensor detects at least a position of the catheter which includes the ultrasonic probe).
Regarding claim 5, Buckley in view of Hyun teaches the probe of claim 2, as set forth above. Hyun further teaches the solenoid is supplied with electric power to generate a magnetic force ([0041] discloses the magnetic field is generated according to a voltage and the magnetic field generator is formed of a solenoid).
Regarding claim 6, Buckley in view of Hyun teaches the probe of claim 5, as set forth above. Hyun further teaches a cable disposed at the back end portion of the ultrasonic probe and supplying the electric power to the solenoid ([0039] discloses a cable 280 connects the probe 100 to the main body 200. [0054] discloses the control unit 250 of main body 200 controls the components of the magnetic field control unit which [0046] discloses controls generation of a magnetic field. [0041] discloses the magnetic field is generated according to a voltage, therefore the cable 280 supplies power to the solenoid as controlled by the control unit to generate the magnetic field).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having a cable disposed at the back end portion of the ultrasonic probe and supplying the electric power to the solenoid of Hyun to the probe of Buckley in view of Hyun to allow for the predictable results of continuously powering the solenoid.
Regarding claim 8, Buckley in view of Hyun teaches the probe of claim 2, as set forth above. Buckley further teaches a probe case that houses the metal inner housing therein (figs. 1-2 disclose polymer layer 12 which houses the inner housing metal layer 14).
Regarding claim 9, Buckley in view of Hyun teaches the probe of claim 8, as set forth above. Buckley further teaches the probe case is adhered to the metal inner housing by an adhesive ([0019] disclose the use layers are adhered to one another using adhesion. Also see claims 17-18).
Regarding claim 12, Buckley in view of Hyun teaches the probe of claim 8, as set forth above. Buckley further teaches the shape of an outer surface of the metal inner housing is configured to correspond to the shape of an inner surface of the probe case (figs. 1 and 2 shows the shape of the outer surface of the inner housing 13 corresponds to the shape of the inner surface of the probe case 12), and wherein a gap formed between the probe case and the inner metal housing is 5 mm or less ([0016] discloses the overall diameter of the catheter is less than 1mm, meaning the gap between the inner housing and the probe case is 5mm or less).
Regarding claim 15, Buckley in view of Hyun teaches the probe of claim 2, as set forth above. Buckley further teaches the ultrasonic transducer is disposed at a front end portion of the ultrasonic probe (fig. 2 shows the transducer 50 is disposed at a front end portion of the probe);
the metal inner housing extends from the front end portion to a back end portion of the ultrasonic probe (fig. 2 shows the metal layer extends from the front end to the back end of the probe);
a front end portion of the metal inner housing has a first front end portion and a second front end portion that are completely separated by a first slit ([0035] discloses the metal housing has an window constructed in it, the part of the housing that is distal to the window is considered the first front end portion and the part of the housing that is proximal to the window is the second front end portion); and
the first front end portion and the second front end portion are supported by a back end portion of the metal inner housing that is not completely divided (the side of the metal layer that does not include the window is considered the back end portion that is not completely divided and support the first and second front end portions).
Regarding claim 16, Buckley in view of Hyun teaches the probe of claim 15, as set forth above. Buckley further teaches the first front end portion and/or the second front end portion comprises one or more windows ([0035] discloses the metal housing includes a window, the part of the housing that includes the window is at least the first front end portion).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Hyun as applied to claim 2 above, and further in view of Shimogami et al. (US 20230132761, hereinafter Shimogami).
Regarding claim 7, Buckley in view of Hyun teaches the probe of claim 2, as set forth above. Buckley further teaches a chassis that fixes the magnetic sensor at a predetermined position in the metal inner housing ([0028] and [0030] discloses integrally attaching the tracking element 20 immediately adjacent to the distal end of the catheter housing. The attaching element is considered the chassis).
Buckley in view of Hyun does not specifically teach the chassis is formed of a resin material.
However,
Shimogami in a similar field of endeavor teaches a chassis that is formed of a resin material ([0041] discloses the main body portion 12 (chassis) is formed of a resin) and includes the magnetic sensor ([0041] and fig. 2 disclose the main body portion includes the magnetic sensor 11).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the chassis be formed of a resin material of Shimogami to the chassis of Buckley in view of Hyun to allow for the predictable results of insulating the magnetic flux from the rest of the ultrasound probe.
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Hyun as applied to claim 8 above, and further in view of Sliwa et al. (US 6122538, hereinafter Sliwa).
Regarding claim 10, Buckley in view of Hyun teaches the probe of claim 8, as set forth above. Buckley further teaches the probe case includes a top surface (the distal end surface of the catheter in fig. 2), a bottom surface (the proximal end surface of the catheter in fig. 2), and a side surface connected to the top surface and the bottom surface (the outer surface 12 in figs. 1 and 2);
the metal inner housing includes a beam member extending along the side surface of the probe case (inner metal layer 14 in figs. 1-2); and
the magnetic sensor is disposed in the inner housing (fig. 2 shows the tracking element (magnetic sensor) is disposed in the inner housing).
Buckley in view of Hyun does not specifically teach the probe case includes a first and second side surfaces connected to the top surface and the bottom surface; the metal inner housing includes a first beam member extending along the first side surface of the probe case and a second beam member extending along the second side surface of the probe case; the magnetic sensor is disposed between the first beam member and the second beam member; and the first pole and the second pole are disposed along a longitudinal axis extending from a front end potion of the ultrasonic probe to a back end portion of the ultrasonic probe.
However,
Sliwa in a similar field of endeavor teaches a probe case includes a first and second side surfaces connected to a top surface and a bottom surface (fig. 1A shows the probe case includes a first and second side surfaces connected to a top surface and a bottom surface); the inner housing includes a first beam member extending along a first side surface of the probe case and a second beam member extending along a side surface of the probe case (the supporting walls of the probe shown in fig. 1A on the sides of the probe); the magnetic sensor is disposed between the first beam member and the second beam member (fig. 1A shows the magnetic sensor 7 is disposed within the side walls); and the first pole and the second pole are disposed along a longitudinal axis extending from a front end potion of the ultrasonic probe to a back end portion of the ultrasonic probe (fig. 1A and col. 7, lines 6-32 disclose each of the coils of the sensor emit their own magnetic dipole field oriented to each coil. Since one of the coils is disposed along the longitudinal axis of the probe the first and second pole are disposed along the longitudinal axis of the probe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the probe case include a first and second side surfaces connected to the top surface and the bottom surface; the inner housing includes a first beam member extending along a first side surface of the probe case and a second beam member extending along a side surface of the probe case; the magnetic sensor is disposed between the first beam member and the second beam member; and the first pole and the second pole are disposed along a longitudinal axis extending from a front end potion of the ultrasonic probe to a back end portion of the ultrasonic probe of Sliwa to the probe of Buckley to allow for the predictable results of providing additional support to the ultrasonic probe.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Hyun and Sliwa as applied to claim 10 above, and further in view of Noguchi et al. (US 20210212664, hereinafter Noguchi).
Regarding claim 11, Buckley in view of Hyun and Sliwa teaches the probe of claim 10, as set forth above. Buckley in view of Hyun and Sliwa does not specifically teach at least one operation button on an upper surface of the probe case, wherein the at least one operation button is positioned between the first beam member and the second beam member.
However,
Noguchi in a similar field of endeavor teaches at least one operation button on an upper surface of the probe case ([0028] discloses switches 15A and 15B on the upper surface of the probe case in fig. 1), wherein the at least one operation button is positioned between the first beam member and the second beam member (fig. 1 shows the switches 15A-15B are positioned between the side walls of the probe).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having at least one operation button on an upper surface of the probe case, wherein the at least one operation button is positioned between the first beam member and the second beam member of Noguchi to the probe of Buckley in view of Hyun and Sliwa to allow for the predictable results of increasing functionality of the probe and also reducing the number of size of the system by integrating the multiple parts into one system.
Claim(s) 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Hyun and Sliwa as applied to claim 10 above, and further in view of Iwashita et al. (US 20240057979, hereinafter Iwashita).
Regarding claim 13, Buckley in view of Hyun and Sliwa teaches the probe of claim 10, as set forth above. Buckley in view of Sliwa does not specifically teach the probe case is made of resin, and the metal inner housing provides main rigidity of the ultrasonic probe.
However,
Iwashita in a similar field of endeavor teaches the probe case is made of resin ([0033] discloses the housing 11 (probe case) is made of resin), and the metal inner housing provides main rigidity of the ultrasonic probe ([0033] and fig. 1 show the shell 12 provides the main rigidity for the ultrasonic probe 10 and is made of metal).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the known technique of having the probe case be made of resin, and the metal inner housing provides main rigidity of the ultrasonic probe of Iwashita to the probe of Buckley in view of Sliwa to allow for the predictable results of providing additional support to the ultrasonic probe.
Regarding claim 14, Buckley in view of Hyun, Sliwa and Iwashita teaches the probe of claim 13, as set forth above. Sliwa further teaches the ultrasonic probe has a rectangular cross-section in a plane perpendicular to the longitudinal axis extending from the front end portion to the back end portion (fig. 1A shows the plane perpendicular to the longitudinal axis of the probe has a rectangular cross section).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Buckley in view of Hyun as applied to claim 2 above, and further in view of Wang et al. (CN110960254A, hereinafter Wang).
Regarding claim 17, Buckley in view of Hyun teaches the probe of claim 2, as set forth above. Buckley in view of Hyun does not specifically teach the metal inner housing has a thickness of 1 to 5 mm.
However,
Wang in a similar field of endeavor teaches the metal inner housing has a thickness of 1 to 5 mm (pg. 3, para. 6 discloses the inner housing has a thickness of 3mm).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the probe disclosed by Buckley in view of Hyun to have the metal inner housing have a thickness of 1 to 5 mm in order to provide additional structural support to the probe, as recognized by Wang (pg. 3, para. 6).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable by Buckley in view of Jian et al. (WO2020238561A1, hereinafter Jian).
Regarding claim 18, Buckley teaches an ultrasonic probe (the system shown in fig. 2 which includes an ultrasound imaging device), comprising:
an ultrasonic transducer ([0024] transducer array 50 in fig. 2);
a metal inner housing that is thermally connected to the ultrasonic transducer ([0025] the catheter housing is composed of a metal layer 14. By surrounding the transducer 50 as shown in fig. 2, the metal layer 14 dissipates thermal heat from the transducer and is therefore thermally connected); and
a magnetic sensor disposed at a position at least partially surrounded by the metal inner housing ([0028]-[0029] discloses the tracking element 20 comprises a field sensor. Claim 11 further discloses the field sensor is a magnetic field sensor. Fig. 2 shows the tracking element 20 is surrounded by the metal layer 14), wherein:
the metal inner housing comprises a magnetic flux line-passing structure that allows passage of magnetic flux lines to detect a magnetic field generated by a transmitter disposed outside the ultrasonic probe ([0035] discloses the metal housing includes an acoustic window (passing structure) that allows passage of magnetic flux lines. [0028]-[0029] and [0035] by having the magnetic sensor be able to track the position of the probe, the passing structure allows passage of a detectable amount of magnetic flux lines to the magnetic sensor), the magnetic flux line-passing structure includes any one or more of a slit, a window, and a non-metal material ([0035] discloses the flux line-passing structure includes at least a window).
Buckley does not specifically teach the ultrasonic transducer is attached to a distal end of the metal inner housing and is aligned to transmit ultrasonic energy distally away from the metal inner housing.
However,
Jian in a similar field of endeavor teaches the ultrasonic transducer is attached to a distal end of the inner housing and is aligned to transmit ultrasonic energy distally away from the inner housing (figs. 1-2 and 6 disclose the ultrasonic probe t1 is attached at a distal end of the housing and is aligned to transmit ultrasonic energy (detection area q1) distally away from the inner housing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute ultrasonic transducer of Buckley for the ultrasonic transducer attached to the distal end of the inner housing of Jian because it amounts to simple substitution of one known element for another to obtain the predictable results of imaging the target area.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable by Buckley et al. in view of Hyun as applied to claim 1 above, and further in view of Jian et al. (WO2020238561A1, hereinafter Jian).
Regarding claim 19, Buckley in view of Hyun teaches the probe of claim 1, as set forth above. Buckley in view of Hyun does not specifically teach the ultrasonic transducer is attached to a distal end of the metal inner housing and is aligned to transmit ultrasonic energy distally away from the metal inner housing.
However,
Jian in a similar field of endeavor teaches the ultrasonic transducer is attached to a distal end of the inner housing and is aligned to transmit ultrasonic energy distally away from the inner housing (figs. 1-2 and 6 disclose the ultrasonic probe t1 is attached at a distal end of the housing and is aligned to transmit ultrasonic energy (detection area q1) distally away from the inner housing).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute ultrasonic transducer of Buckley for the ultrasonic transducer attached to the distal end of the inner housing of Jian because it amounts to simple substitution of one known element for another to obtain the predictable results of imaging the target area.
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 ANDREW BEGEMAN whose telephone number is (571)272-4744. The examiner can normally be reached Monday-Thursday 8:30-5:00.
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, Keith Raymond can be reached at 5712701790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANDREW W BEGEMAN/Primary Examiner, Art Unit 3798
Prosecution Insights