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 .
Status of Claims
Claims 1-2,4-5,7-18, and 20-23 are pending in this application. Claims 20-23 are withdrawn, and Claims 1-2,4-5, and 7-18 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of claims 1-2,4-5, and 7-18 drawn to Invention I on
12/04/25 is acknowledged.
Claims 20-23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being
drawn to a nonelected Invention II drawn to a three-dimensional magnetic positioning system, there being no allowable generic or linking claim.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 7-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation of “the structural member defines a first channel whose axis is at an angle with an axis of the structural member”. It is unclear which axis is being referred to as it is not defined i.e. what axis the structural member is lying on. For purposes of examination, the limitation will be construed as the structural member lying on the longitudinal axis. However, further clarification is required.
Claim 12 recites the limitation of “the second channels are configured for accommodating therein the second magnetic sensor, or for passing therethrough the second magnetic sensor and lead thereof, or for flowing therethrough a medium, wherein on a circumference of the structural member”. It is unclear whether there are three second magnetic sensors which are all in the second channels, or if there is just one second sensor in one second channel. For purposes of examination, the limitation will be construed as one second sensor, which is held in the one second channel and other wires/sensors being placed in the remaining second channels (in light of Embodiment 1 of the Specifications “there may be three second channels 315, one of which may be configured to receive the second magnetic sensor 342 therein. Another one of the second channels 315 may be configured for passage of sensor and/or other leads (e.g., a lead of a force sensor, a lead of a temperature sensor and/or a lead of the tip electrode 313), and the remaining one of the second channels 315 may be configured to introduce a medium for cooling the tip electrode 313, such as physiological saline. It will be appreciated that the bending-adjustable section 320 may be a multi-lumen tube having lumens each corresponding to a respective one of the three second channels 315”). However, further clarification is required.
Claim 13 recites the limitation “wherein the straight edges of the other inclined relative to the line”. It is unclear what is meant by the other inclined relative to the line and what “the other” is referring to, and further the angle of the mentioned incline in comparison to the line. For purposes of examination, the limitation will be construed as one of the second channels being at an angle to the line. However, further clarification is required.
Claim 14 recites the limitation “wherein the second magnetic sensor is at least partially disposed in the third channel”. It is unclear what is meant by this as Claim 12 recites the second magnetic sensor to be in the second channel, and the second channel and third channel are separate structures, which appear to not overlap (see Figure 16). For purposes of examination, the limitation will be construed as the magnetic sensor being positioned near the channel. However, further clarification is required.
Further, Claim 14 recites the limitation “the tip electrode defining a third channel”. It is unclear whether the tip electrode is the third channel, or if the tip electrode is in the third channel. For purposes of examination, the limitation is construed as a tip electrode, which has a wiring that acts as the third channel. However, further clarification is required.
Claim 16 recites the limitation “an axis of the third channel is parallel to an axis of the tip electrode”. It is unclear which axis is being referred to for the third channel or the tip electrode as they are not defined i.e. longitudinal. For purposes of examination, the limitation will be construed as the third channel and tip electrode axis being parallel laterally (as notated based off Figure 16 of the Drawings). However, further clarification is required.
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Figure 16 of the present application
The remaining claims are rejected due to their dependency to the rejected claims above.
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 1-2, 4, and 14-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Xiaolin (CN111001075B, disclosed in Applicant IDS).
Regarding Claim 1,
Xiaolin teaches a medical catheter, comprising a catheter body (corresponding disclosure in at least [ln 39], where there is a catheter “A catheter with shape and position display, comprising a catheter head end”), a first magnetic sensor and a second magnetic sensor (corresponding disclosure in at least [ln 42], where there are two magnetic sensors “a magnetic positioning sensor, a second magnetic positioning sensor is provided”), the catheter body comprising, sequentially connected along an axis thereof, a tip section, a bending-adjustable section and a straight section, both the first and second magnetic sensors disposed on the tip section (corresponding disclosure in at least [ln 39-41], where there is a tip section and a bendable section, with the sensors on the tip (head) “comprising a catheter head end and an adjustable bendable segment pipe body connected to it, a magnetic positioning sensor assembly and a pressure sensor are arranged in the catheter head end” and Figure 6, where there is a straight section after the bendable section).
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Figure 6 of Xiaolin
Regarding Claim 2,
Xiaolin further teaches the medical catheter according to claim 1, wherein the first and second magnetic sensors are oriented at an angle with respect to each other; wherein the angle oriented between the first and second magnetic sensors ranges from 5° to 175° (corresponding disclosure in at least [ln 81-83] and Figure , where the sensors are not parallel, and thus angled with an angle within the range “The sensor is not arranged in parallel with the first magnetic positioning sensor, so that the positioning accuracy can be improved and the rotation direction of the catheter can be expressed, that is, it has six degrees of freedom” and further in [ln 77], where the angle within the range is disclosed “an angle A is formed between the axial direction of the third magnetic positioning sensor and the axial direction of the first magnetic positioning sensor, and the angle A is (0°, 90°)”).
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Figure 1 of Xiaolin
Regarding Claim 4,
Xiaolin further teaches wherein the tip section comprises a structural member having a proximal end connected to the bending-adjustable section, wherein the first magnetic sensor is disposed on the structural member (corresponding disclosure in at least Figure 1, where there is a proximal end connected to a bending section, with the magnetic sensor on the structural member (proximal end)).
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Figure 1 of Xiaolin
Regarding Claim 14,
Xiaolin further teaches wherein the tip section comprises a tip electrode which is disposed at a distal end of the tip section, the tip electrode defining a third channel, wherein the second magnetic sensor is at least partially disposed in the third channel (corresponding disclosure in at least Figure 1 and [ln 286], where there is a tip electrode (electrodes on the end of the catheter head, which includes the third channel (wiring), Figure7) “the catheter head end 1 is a hard end, There are several electrodes on it”).
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Figure 1 of Xiaolin
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Figure 7 of Xiaolin
Regarding Claim 15,
Xiaolin further teaches wherein the first and second magnetic sensors are staggered from one another, both circumferentially around and axially along the tip section (corresponding disclosure in at least Figure 1, where the sensors are staggered from one another; Examiner is interpreting “staggered” to mean the sensors to not be on top of each other to avoid interference, which is consistent with “Embodiment 3” of the Specifications. Xiaolin discloses the sensors to not be on top of each other and have some distance between each other circumferentially).
Regarding Claim 16,
Xiaolin further teaches wherein an axis of the third channel is parallel to an axis of the tip electrode (corresponding disclosure in at least [ln 285-288] and Figure 7, where there are wirings (third channel), which are parallel to an axis of the tip (the defined axis is shown in the Figure below) “the catheter head end 1 is a hard end, There are several electrodes on it, the adjustable bendable section tube body 2 is a braided tube body, and a braided mesh of stainless steel wire is used to increase the rigidity and torque transmission of the tube body”).
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Figure 7 of Xiaolin
Regarding Claim 17,
Xiaolin further teaches wherein the tip section further comprises an elastomer provided thereon with a strain sensor, the strain sensor configured for sensing a magnitude of an external force that the tip section is subject to when deforming (corresponding disclosure in at least [ln 334-336], where the “the pressure sensor 7 includes an elastic body 71 and a strain sensor assembly 72. The elastic body 71 is used for the deformation of the catheter tip 1 after abutting against the tissue and the reset after separation”).
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.
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 5, 7-8, 10, are rejected under 35 U.S.C. 103 as being unpatentable over Xiaolin (CN111001075B) in view of Shameli (US20190388156A1).
Regarding Claim 5, Xiaolin teaches the limitations of Claim 4, and further teaches wherein the second magnetic sensor is disposed on the structural member (corresponding disclosure in at least Figure 1, where there is a proximal end connected to a bending section, with the magnetic sensor on the structural member (proximal end)), but does not teach wherein the structural member defines a first channel whose axis is at an angle with an axis of the structural member, wherein the first magnetic sensor is at least partially disposed in the first channel.
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Figure 1 of Xiaolin
Shameli, in a similar field of endeavor, teaches a similar concept (surgical navigation systems) of wherein the structural member defines a first channel whose axis is at an angle with an axis of the structural member, wherein the first magnetic sensor is at least partially disposed in the first channel (corresponding disclosure in at least [0050] and Figure 8, where there is a channel (wire) which is at an angle from the structure and also has a sensor disposed on the first channel (the channel/wire is connected on the sensor, thus disposed partially) “ A first wire (530) is coupled with a first end of first sensor”).
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Figure 8 of Shameli
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated a channel at an angle of the structural member with the magnetic sensor partially disposed as taught by Shameli. One of the ordinary skill in the art would have been motivated to incorporate this because the channel provides a method of communication for the sensor for signals in regard to the location and position.
Regarding Claim 7, the combined references of Xiaolin and Shameli teach the limitations of Claim 5, and Shameli further teaches wherein the structural member further defines a second channel, which is spaced apart from the first channel circumferentially around the structural member and has an axis that is at an angle with the axis of the first channel, wherein the second magnetic sensor is at least partially disposed in the second channel (corresponding disclosure in at least [0050] and Figure 8, where there is a channel (wire) which is at an angle from the structure and also has a sensor disposed on the first channel (the channel/wire is connected on the sensor, thus disposed partially) “ A first wire (530) is coupled with a first end of first sensor”).
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Figure 8 of Shameli
Regarding Claim 8, Xiaolin and Shameli teach the limitations of Claim 7, and Shameli further teaches wherein the axis of the second channel is configured to be parallel to the axis of the structural member (corresponding disclosure in at least Figure 8, where the 2nd channel is parallel).
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Figure 8 of Shameli
Regarding Claim 10, Xiaolin and Shameli teach the limitations of Claim 5,
wherein the angle between the axis of the first channel and the axis of the structural member ranges from 5° to 10° (corresponding disclosure in at least [ln 228-231] and Figure 4, where the angle is 5° (the second channel is parallel to the structure member, thus the first channel, which is at an angle from the second channel, would also be angled with the structure member) “In the catheter with shape and position display according to the present invention, the included angle A that is too small cannot be recognized by the system, and the included angle A that is too large will take up more space, so the included angle A cannot be recognized by the system. A is [5°, 15°]”).
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Figure 5 of Xiaolin
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Xiaolin (CN111001075B) and Shameli (US20190388156A1) as applied in Claim 5, and in further view of Greenan (US20080171934A1).
Regarding Claim 9, Xiaolin and Shameli teach the limitations of Claim 5, and Shameli further teaches wherein the second magnetic sensor comprises an inductive coil at least partially winding on an outer circumferential surface of the structural member or wherein the structural member comprises a non-ferromagnetic body and a ferromagnetic core tube disposed over the body, wherein the first channel is defined in the body and the second magnetic sensor comprises an inductive coil at least partially wound on an outer circumferential surface of the structural member (corresponding disclosure in at least Figure 8 and [0042], where there is a sensor comprised of a coil winding about a surface of the structure “A pair of sensors (310, 320) are secured to body (302), near distal end (304). First sensor (310) is in the form of a cylindrical coil that is positioned about the perimeter of body (302), coaxially positioned with longitudinal axis (LA4). Second sensor (320) is in the form of a pancake coil that is secured to first sensor (310)”), but does not teach wherein the structural member is configured to be ferromagnetic.
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Figure 8 of Shameli
Greenan, in a similar field of endeavor, teaches a similar concept (surgical navigation system) of wherein the structural member is configured to be ferromagnetic (corresponding disclosure in at least [0153], where there is a coil around a ferromagnetic structure (core), “the illustrated marker assembly 1214 includes a coil 1230 wound around a ferromagnetic core 1232 to form an inductor (L)”)
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the ferromagnetic core as taught by Greenan. One of the ordinary skill in the art would have been motivated to incorporate this because the strength of the ferromagnetic material provides stronger signals for the sensor.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Xiaolin (CN111001075B) and Shameli (US20190388156A1) as applied in Claim 5, and in further view of Buesseler (US20180289356A1).
Regarding Claim 11, Xiaolin and Shameli teach the limitations of Claim 5, and Shameli teaches the first channel ([0050]), but does not teach wherein the structural member defines one said first channel and three second channels, which are circumferentially spaced apart from one another, wherein at least one of the second channels is in an angle with the first channel, and in a radial cross-section of the structural member, each of the second channels has an at least partially open contour.
Buesseler, in a similar field of endeavor, teaches a similar concept (magnetic sensor devices) of wherein the structural member defines one said first channel and three second channels, which are circumferentially spaced apart from one another, wherein at least one of the second channels is in an angle with the first channel, and in a radial cross-section of the structural member, each of the second channels has an at least partially open contour (corresponding disclosure in at least [0061] and Figure 5B, where there are channels (trenches, which are spaced apart and are at an angle with the first channel [pathway 503], with an open contour as detailed in the Figure) “At a proximal portion of the coupler 500, trenches 501 and 502 extend along a length of a circumferentially extending outer surface”).
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Figure 5B of Buesseler
Buesseler discloses the claimed invention except for having three second channels. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have two second channels (trenches) 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.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the three second channels, which are circumferentially spaced apart from one another, wherein at least one of the second channels is in an angle with the first channel, and in a radial cross-section of the structural member, each of the second channels has an at least partially open contour as taught by Buesseler. One of the ordinary skill in the art would have been motivated to incorporate this because the open contour provides an opening to place sensors in the device.
Regarding Claim 12, the combined references noted above teach the limitations of Claim 11, and Buesseler further teaches wherein the second channels are configured for accommodating therein the second magnetic sensor, or for passing therethrough the second magnetic sensor and lead thereof, or for flowing therethrough a medium (corresponding disclosure in at least [0048], where the magnetic sensor is in the second channel (trench) “, magnetic sensors 101 and 102 are placed within trenches 108 which extend into a top surface of the coupler”),
wherein on a circumference of the structural member, one of the three second channels opposes the first channel, and the remaining two second channels are located on opposing sides of the first channel, and wherein in the radial cross-section of the structural member, the contour of each of the second channels comprises an arc edge and two straight edges extending from respective ends of the arc edge (corresponding disclosure in at least Figure 5B, where there channels (trenches) on opposing sides of the first channel with the second channels (trenches) having an arc edge with two straight edges).
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Figure 5B of Buessler
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Xiaolin (CN111001075B).
Regarding Claim 18,
Xiaolin teaches a third magnetic sensor and a fourth magnetic sensor, which are disposed within the straight section at a distal end thereof and are oriented at an angle with respect to each other; wherein the first, second, third and fourth magnetic sensors are all five-degree-of-freedom sensors (corresponding disclosure in at least [ln 311], where there is a magnetic sensor with 5 degrees of freedom “the first magnetic positioning sensor T1 is the same as the catheter tube body Therefore, the first magnetic positioning sensor T1 has five degrees of freedom”).
Xiaolin discloses the claimed invention except for a third and fourth magnetic sensor. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have one magnetic sensor that is a five degree of freedom sensor 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.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
The subject matter of claim 13 in light of the Specifications and Figure 9 avoids the prior art. It is understood that the subject matter describes a structural member designed to hold sensors within the three second channels, which are contoured into the structural member as shown in Figure 9. The structural member is uniquely designed to use as much of the structure space without having sensors overlap, ultimately providing a compact structure for the sensors and their wires. Buesseler teaches a structure with the open contours for holding sensors, etc., but is silent on how the straight edges of the other inclined relative to the line, and a distance from a center of the arc edge of the other to the center of the arc edge of the second channel in opposition to the first channel is smaller than a distance from the center of the arc edge of the other to the center of the first channel (see figures below).
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Figure 5B of Buesseler
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Figure 9 of present application
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN KIM whose telephone number is (571)272-1821. The examiner can normally be reached Monday-Friday 6-2 PST.
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797