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
Applicant’s amendments and remarks, filed 10/30/2025, are acknowledged. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 25-44 are currently under examination.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application discloses and claims only subject matter disclosed in prior application n° 14/919,950, filed 10/22/2015, now abandoned, and names the inventor or at least one joint inventor named in the prior application.
Priority claiming the benefit of US Provisional Application 62/095,563, filed 10/22/2014, is acknowledged.
Response to Arguments
Applicant’s responses and arguments filed 10/30/2025 regarding claim rejections under 35 USC 103 have been fully considered.
Applicant argues that Glossop does not teach the catheter and the guidewire having each a EM sensor at the distal tip of them.
In response, the examiner has found that Glossop is teaching that both catheter and guidewire have a position indicating element ([0010], [0026] “a guidewire equipped with one or more position indicating elements, at least one being located at or near the tip of the guidewire” and [0029] “the catheter itself may be tracked using a tracking system and one or more position indicating elements”) wherein the position indicating elements may comprise an electromagnetic coil producing EM field ([0017]) or any other type of sensor ([0017]). Since the instant claims are directed to apparatus/device, such coils are also capable to sense external fields therefore playing the function of EM coil sensor for tracking/navigation. This is the position of the examiner since while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431 - 32 (Fed. Cir. 1997). Therefore the examiner is considering the argument as not persuasive.
Applicant further argues that Nevo is facially deficient since no motivation was provided to combine Nevo and Glossop.
In response, the examiner introduce Nevo to support the teaching of Glossop for the choice of using electromagnetic coils for both the catheter and the guidewire, as already suggested by Glossop, as discussed above, therefore with the motivation being providing already by Glossop.
Applicant further argues that no rational is provided for modifying Nevo by Acker.
In response, the examiner has provided a rational for relying on Acker teachings. As discussed above, Acker is not directed to Nevo which relied teachings was only to support the obviousness of Glossop teachings but Acker was relied upon to Glossop to define the coils disposition and making to ensure proper function for the claimed navigation of Glossop for his catheter and his guidewire when advanced within the subject towards the target region as provided in the rational. Therefore the argument is found not persuasive.
Applicant argues that Carmeli does not teach the claim limitation related to the orientation of the coils with the coils on the same device being in opposite orientation, since Carmeli teach the coils having clockwise and counterclockwise current orientations on the device.
In response, the examiner has relied upon Carmeli to teach that the disposition of magnetic coils can be oriented facing each other as clockwise counterclockwise in regard of the current passing through them since definition of the orientation of magnetic coil is made with its north and south faces dependent on the current path within the coil. Since Carmeli is defining the clockwise and counterclockwise orientation of the coils using the current, the examiner is considering the teachings of Carmeli is reading on the claim limitation for the coils orientations as being opposite. Therefore the examiner is considering the argument as not persuasive.
In conclusion, the examiner has fully considered the Applicant’s arguments and found them not persuasive and maintains the claims rejections under 35 U.S.C. 103 as proper. The claims rejections under 35 U.S.C. 103 are therefore maintained.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 25-28, 30-32, 36-40, 42-44 are rejected under 35 U.S.C. 103 as being unpatentable over Glossop (USPN 20060184016 A1; Pub.Date 08/17/2006 ; Fil.Date 01/18/2006) in view of Nevo et al. (USPN 20130303878 A1; Pub.Date 11/14/2013; Fil.Date 01/19/2012) in view of Acker et al. (USPN 6253770 B1; Pat.Date 07/03/2001; Fil.Date 02/14/1997) in view of Carmeli et al. (USPN 20120302820 A1; Pub.Date 11/29/2012; Fil.Date 06/08/2012) in view of Lyu et al. (USPN 20110066029 A1; Pub.Date 03/17/2011; Fil.Date 09/11/2009).
Regarding independent claim 25, Glossop teaches:
An electromagnetic (EM) lung navigation system (Title and abstract “The invention provides methods and apparatus for navigating a medical instrument to a target in the lung”), comprising:
a catheter (abstract “the invention includes inserting a bronchoscope into the lung, inserting a catheter into the lung through the working channel of the bronchoscope” and [0025]-[0026]); comprising:
a catheter (abstract “the invention includes inserting a bronchoscope into the lung, inserting a catheter into the lung through the working channel of the bronchoscope” and [0025]-[0026]) including; a first EM sensor disposed on a distal portion of the catheter, ([0017]-[0018] including a coil system at the tip of the instrument).
[…the first EM sensor including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils…];
a locatable guide configured to be inserted through a working channel of the catheter for navigating the locatable guide catheter and the catheter to a target location within the patient's airways (abstract “inserting a tracked navigation instrument wire into the lung through the catheter, navigating the tracked navigation instrument through the lung to the target, advancing the catheter over the tracked navigation instrument to the target” wherein the tracked navigation instrument wire is identified with the locatable guide catheter advancing through a channel of the catheter with navigating the catheter once the guide catheter reaches the target location towards that target , the target being within the lung) including; a second EM sensor disposed on the distal portion of the locatable guide, ([0017]-[0018] including a coil system at the tip of the instrument used for [0026] guidewire with one or more position indicating elements at the distal tip), wherein Nevo teaches within the same field of endeavor of catheter for diagnostics (Title and abstract and [0014]-[0019]) the use of magnetic coils on the guidewire and catheter for performing magnetic navigation of the probe system, making obvious the disposition of tracking magnetic coils on both the catheter and the guidewire therefore teaching the first the first and second EM sensors in order to track and guide the catheter and guidewire towards the target region.
[…the second EM sensor including: a third conductive coil; a fourth conductive coil; and a second non-conductive material covering the third and fourth conductive coils, wherein the first coil and third conductive coil each have a clockwise orientation, and the second coil and fourth conductive coil each have a counterclockwise orientation, and wherein a distance between adjacent loops of one of the first, second, third, or fourth conductive coils is different than a distance between adjacent loops of another one of the first, second, third, or fourth conductive coils…]
Glossop and Nevo do not specifically teach the first EM sensor including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils and the second EM sensor including: a third conductive coil; a fourth conductive coil; and a second non-conductive material covering the third and fourth conductive coils, wherein the first coil and third conductive coil each have a clockwise orientation, and the second coil and fourth conductive coil each have a counterclockwise orientation, and wherein a distance between adjacent loops of one of the first, second, third, or fourth conductive coils is different than a distance between adjacent loops of another one of the first, second, third, or fourth conductive coils as in claim 25.
However, Acker teaches within the same field of endeavor of catheter or similar device with position detector (Title and abstract) the position detector having at least two separate coils (Figs. 5A-5B and col.9 2nd ¶ to col. 10 1st ¶ and Figs.11-12 sensors wrapped around the tip of as catheter or elongated tools with separate conductive coils wounded and facing each other to allow precise positioning of the distal end of the tool with the wrapping performed in different fashions as designed). Additionally, Acker teaches the use of a sheath or protective coating above the coils (col.14 3rd ¶) therefore reading on the first EM sensor on the catheter including the first sensor disposed including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils and one of ordinary skill in the art would have also applied the same technique of positioning for the locatable guide catheter as taught by Nevo as discussed above therefore reading on the second EM sensor including the second EM sensor including: a third conductive coil; a fourth conductive coil; and a second non-conductive material covering the third and fourth conductive coils.
Additionally, Carmeli teaches within the same field of endeavor using catheter (Title and abstract and [0011]-[0013] with navigation of catheter) the use of sensor coils (Fig.2B and [0153] such as coils 227 and 228 or 229 and 224 as considered two sensor sets wherein coil 227 is clockwise and coil 228 is counterclockwise and facing each other and wherein coil 229 is clockwise and coil 224 is counterclockwise) teaching wherein the first coil and third conductive coil each have a clockwise orientation, and the second coil and fourth conductive coil each have a counterclockwise orientation as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo such that the apparatus further comprises: the first EM sensor including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils and the second EM sensor including: a third conductive coil; a fourth conductive coil; and a second non-conductive material covering the third and fourth conductive coils, wherein the first coil and third conductive coil each have a clockwise orientation, and the second coil and fourth conductive coil each have a counterclockwise orientation,, since one of ordinary skill in the art would recognize that using such EM sensors wound around the longitudinal axis of a catheter or elongated tool at their distal tip with two electromagnetic coils wound on the sensor and facing each other across the longitudinal axis was known in the art with the relative position of the adjacent coils as being overlapping or not with the neighboring coils as taught by Acker and since the sensors are presenting the coils as one wound clockwise and the other wound counter clockwise when unwrapped as taught by Carmeli. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Glossop, Acker and Carmeli teach navigation systems for catheter using magnetic sensors. The motivation would have been to provide sensors for positioning and orienting each of the different elongated medical tools for minimal invasive procedures with a small profile to allow to keep minimal the size of the medical tool, as suggested by Acker (col.3 5th ¶).
Glossop, Nevo, Acker and Carmeli do not specifically teach wherein a distance between adjacent loops of one of the first, second, third, or fourth conductive coils is different than a distance between adjacent loops of another one of the first, second, third, or fourth conductive coils as in claim 25.
However, Lyu teaches within the same field of endeavor of navigating a catheter (Title and abstract and [0019] Fig.1 “sensing coils form by wrapping wire around an outer wall 34 … Core 36 desirably sufficiently flexible to facilitate insertion and navigation of catheter 10), a catheter (Title and abstract and [0019] Fig.1 “sensing coils form by wrapping wire around an outer wall 34 … Core 36 desirably sufficiently flexible to facilitate insertion and navigation of catheter 10); comprising: a catheter (Title and abstract and [0019] Fig.1 “sensing coils form by wrapping wire around an outer wall 34 … Core 36 desirably sufficiently flexible to facilitate insertion and navigation of catheter 10) including; a first EM sensor disposed on a distal portion of the catheter, (Fig.1 and sensor coils 44 and 42 to consider as one EM sensor placed on the distal part of the catheter 10), the first EM sensor including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils ([0032] each coils being made of metal such as copper, gold and other medically acceptable metal and each wire being covered as insulated wire) wherein Lyu teaches also the sensor coils 444, 442, 440 and 438 made flexible with one of the coil 444 made more flexible than the other with “more widely spaced turns of wire” than the other coils 442, 440 and 438 ([0024]), therefore teaching wherein a distance between adjacent loops of one of the first, second, third, or fourth conductive coils is different than a distance between adjacent loops of another one of the first, second, third, or fourth conductive coils as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker and Carmeli such that the apparatus further comprises: wherein a distance between adjacent loops of one of the first, second, third, or fourth conductive coils is different than a distance between adjacent loops of another one of the first, second, third, or fourth conductive coils, since one of ordinary skill in the art would recognize that using such EM coil sensors wound around the longitudinal axis of a catheter or elongated tool at their distal tip wherein the winding provide different distances between adjacent loops within different coils was known in the art as taught by Lyu. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Glossop, Carmeli and Lyu, teach navigation systems for catheter using magnetic sensors for position sensing. The motivation would have been to provide some relative flexibility to the catheter with the presence of the coil sensors as suggested by Lyu ([0024]).
Regarding the dependent claims 26-28, 30-32, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Glossop, Nevo, Acker, Carmeli and Lyu.
Regarding claim 26, as discussed above, Carmeli teaches the disposition of the coils as the two coils placed face to face and with opposite orientations (Figs.2B) therefore teaching the first and second conductive coils face each other across a longitudinal axis of the catheter.
Regarding claim 27, as discussed above, Lyu (Fig. 1 and 4) teach the coils being wrapped around the instrument such as the catheter and therefore also the guidewire therefore teaching the first and second conductive coils are in their respective orientations prior to the first EM sensor being wrapped around the distal portion of the catheter.
Regarding claim 28, as referred above, Lyu (Fig.4) teaches the coil design as providing several layers ([0022]) in order to improve the efficiency of the coils therefore teaching each of the first and second conductive coils includes multiple layers of wire wound around the distal portion of the catheter; and each of the third and fourth conductive coils includes multiple layers of wire wound around the distal portion of the locatable guide as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the apparatus further comprises: each of the first and second conductive coils includes multiple layers of wire wound around the distal portion of the catheter; and each of the third and fourth conductive coils includes multiple layers of wire wound around the distal portion of the locatable guide, since one of ordinary skill in the art would recognize that using such EM coil sensors wound around the longitudinal axis of a catheter or elongated tool at their distal tip with several layers was known in the art as taught by Lyu. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Glossop, Carmeli and Lyu, teach navigation systems for catheter using magnetic sensors for position sensing. The motivation would have been to improve the efficacity of the sensoring coils, as suggested by Lyu ([0022]).
Regarding claim 30, Glossop teaches the use of a pair of conducting wire running along the elongated medical device (Fig.2 coupled wires 211 and [0047]), Nevo teaching the connection to the tracking processor (Fig. 1) and Carmeli teaches the optional connection of each of the coils either in parallel or in series to the processor (Fig.2A-D [0153]-[0156])) teaching therefore each of the conductive coils having two connecting ends therefore teaching a pair of wires extending from the first EM sensor along a length of the catheter, the pair of wires configured to electrically couple to an EM tracking device for determining the location of the distal portion of the catheter.
Regarding claim 31, as discussed above, Nevo teaches the use of similar coil system for positioning the catheter and the guidewire. Therefore as discussed above for claim 30 the use of pairs of wire connecting the coils to the tracking device is also taught to be applied to the guidewire therefore Glossop, Nevo, Acker, Carmeli and Lyu also teaching a pair of wires extending from the second EM sensor along a length of the locatable guide, the pair of wires configured to electrically couple to an EM tracking device for determining a location of the distal portion of the locatable guide as claimed.
Regarding claim 32, Glossop teaches also the use of gating device or a dynamic referencing device for synchronizing the acquisition of position/orientation information to the regular motion of the navigated devices ([0010]-[0011], [0084] “a dynamic referencing device (see those described above) is applied to the patient (either prior to or after registration) and used to compensate for chest and heart motion and/or various other patient motions in the region of interest” and [0085] “dynamic referencing can be performed using a surface tracker such as a skin patch or other surface device.” and [0087] for registration of all sensors positions and reference devices position) reading on a device for compensation with the acquisition of the navigated location/orientation of the catheter and guidewire and the breathing motion sensor and wherein the tracking element/sensor can be passive magnetic tracked sensors ([0104]) teaching a third EM sensor configured for placement external to a patient and to detect movement associated with a breathing pattern of the patient, wherein determination of a location of the distal portion of the catheter or locatable guide is compensated for by the detected breathing pattern; and an electromagnetic EM tracking device configured to receive output signals from the first, second, and third EM sensors to determine a location of the distal portion of at least one of the catheter or the locatable guide.
Regarding independent claim 36, claim 36 is directed to an apparatus comprising a catheter presenting the same structural limitations as claimed for the catheter claimed in independent claim 25. Since Glossop, Nevo, Acker, Carmeli and Lyu teach all the functional and structural limitations claimed for the catheter as clamed in claim 25, Therefore the above comments and conclusions apply directly mutatis mutandis to the subject matter of claim 36 and Glossop, Nevo, Acker, Carmeli and Lyu disclose claim 36.
Regarding the dependent claims 37-40, 42-44, all the elements of these claims are instantly disclosed or fully envisioned by the combination of Glossop, Nevo, Acker, Carmeli and Lyu.
Regarding claim 37, as discussed above, Carmeli teaches the disposition of the coils as the two coils placed face to face and with opposite orientations (Figs.2B) therefore teaching the first and second conductive coils face each other across a longitudinal axis of the catheter.
Regarding claim 38, as discussed above, Lyu (Fig. 1 and 4) teach the coils being wrapped around the instrument such as the catheter and therefore also the guidewire therefore teaching the first and second conductive coils are in their respective orientations prior to the first EM sensor being wrapped around the distal portion of the catheter.
Regarding claim 39, as referred above, Lyu (Fig.4) teaches the coil design as providing several layers ([0022]) in order to improve the efficiency of the coils therefore teaching each of the first and second conductive coils includes multiple layers of wire wound around the distal portion of the catheter; and each of the third and fourth conductive coils includes multiple layers of wire wound around the distal portion of the locatable guide as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the apparatus further comprises: each of the first and second conductive coils includes multiple layers of wire wound around the distal portion of the catheter; and each of the third and fourth conductive coils includes multiple layers of wire wound around the distal portion of the locatable guide, since one of ordinary skill in the art would recognize that using such EM coil sensors wound around the longitudinal axis of a catheter or elongated tool at their distal tip with several layers was known in the art as taught by Lyu. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Glossop, Carmeli and Lyu, teach navigation systems for catheter using magnetic sensors for position sensing. The motivation would have been to improve the efficacity of the sensoring coils, as suggested by Lyu ([0022]).
Regarding claim 40, Glossop teaches the use of a pair of conducting wire running along the elongated medical device (Fig.2 coupled wires 211 and [0047]), Nevo teaching the connection to the tracking processor (Fig. 1) and Carmeli teaches the optional connection of each of the coils either in parallel or in series to the processor (Fig.2A-D [0153]-[0156]) teaching therefore each of the conductive coils having two connecting ends therefore teaching a pair of wires extending from the first EM sensor along a length of the catheter, the pair of wires configured to electrically couple to an EM tracking device for determining the location of the distal portion of the catheter.
Regarding claim 42, Glossop teaches as discussed for claim 25, the catheter includes a working channel configured to receive a locatable guide as configured to be inserted through a working channel of the catheter for navigating the locatable guide and the catheter to a target location within the patient's airways (abstract “inserting a tracked navigation instrument wire into the lung through the catheter, navigating the tracked navigation instrument through the lung to the target, advancing the catheter over the tracked navigation instrument to the target” wherein the tracked navigation instrument wire is identified with the locatable guide catheter advancing through a channel of the catheter with navigating the catheter once the guide catheter reaches the target location towards that target, the target being within the lung) with the locatable guide including; a second EM sensor disposed on the distal portion of the locatable guide, ([0017]-[0018] including a coil system at the tip of the instrument), wherein Nevo teaches within the same field of endeavor of catheter for diagnostics (Title and abstract and [0014]-[0019]) the use of magnetic coils on the guidewire and catheter for performing magnetic navigation of the probe system, making obvious the disposition of tracking magnetic coils on both the catheter and the guidewire/locatable guide therefore teaching the first the first and second EM sensors in order to track and guide the catheter and guidewire towards the target region.
Additionally as discussed for claim 36 and claim 25, Acker teaches the catheter or similar device with position detector (Title and abstract) the position detector having at least two separate coils (Figs. 5A-5B and col.9 2nd ¶ to col. 10 1st ¶ wrapped around the tip of as catheter or elongated tools with separate conductive coils wounded) with Carmeli and Lyu teaching as discussed above, the coil sensors wrapped around the instruments along their longitudinal axis of the distal parts and facing each other to allow precise positioning of the distal end of the tool with the wrapping performed in different fashions as designed. Additionally, Acker teaches the use of a sheath or protective coating above the coils (col.14 3rd ¶) therefore reading on the first EM sensor on the catheter including the first sensor disposed including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils and one of ordinary skill in the art would have also applied the same technique of positioning for the locatable guide catheter as taught by Nevo as discussed above therefore reading on the second EM sensor including the second EM sensor including: a third conductive coil; a fourth conductive coil; and a second non-conductive material covering the third and fourth conductive coils.
Additionally, Carmeli teaches within the same field of endeavor using catheter (Title and abstract and [0011]-[0013] with navigation of catheter) the use of sensor coils (Fig.2B and [0153] such as coils 227 and 228 or 229 and 224 as considered two sensor sets wherein coil 227 is clockwise and coil 228 is counterclockwise and facing each other and wherein coil 229 is clockwise and coil 224 is counterclockwise) teaching wherein the first coil and third conductive coil each have a clockwise orientation, and the second coil and fourth conductive coil each have a counterclockwise orientation as claimed in clam 42.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the apparatus further comprises: the catheter includes a working channel configured to receive a locatable guide, the locatable guide including a second EM sensor disposed on a distal portion of the locatable guide and formed of a third conductive coil, a fourth conductive coil, and a second non-conductive material covering the third and fourth conductive coils, wherein the third conductive coil has a clockwise orientation and the fourth conductive coil has a counterclockwise orientation, since one of ordinary skill in the art would recognize that using such EM sensors wound around the longitudinal axis of a catheter or elongated tool such as the guidewire at their distal tip with two electromagnetic coils wound on the sensor and facing each other across the longitudinal axis was known in the art with the relative position of the adjacent coils as being overlapping or not with the neighboring coils as taught by Acker and Nevo and since one of ordinary skill in the art would recognize that using such EM sensors wound around the longitudinal axis of a catheter or elongated tool at their distal tip with two electromagnetic coils wound on the sensor and facing each other across the longitudinal axis was known in the art with the relative position of the adjacent coils as being overlapping or not with the neighboring coils as taught by Acker, Carmeli and Lyu and since the sensors are presenting the coils as one wound clockwise and the other wound counter clockwise when unwrapped as taught by Carmeli. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Glossop, Acker and Carmeli teach navigation systems for catheter using magnetic sensors. The motivation would have been to provide sensors for positioning and orienting each of the different elongated medical tools for minimal invasive procedures with a small profile to allow to keep minimal the size of the medical tool, as suggested by Acker (col.3 5th ¶).
Regarding claim 43, Glossop teaches the catheter includes a working channel configured to receive a biopsy tool as configured to be inserted through a working channel of the catheter for navigating biopsy tool and the catheter to a target location within the patient's airways (abstract [0028] “inserting a medical instrument into the catheter, thus bringing the medical instrument in proximity to the target” wherein the medical instrument is identified with a biopsy device advancing through a channel of the catheter ([0014]-[0016]) with the a biopsy device including; a second EM sensor disposed on the distal portion of the biopsy device, ([0016]-[0018] including a coil system at the tip of the instrument), therefore teaching the first the first and second EM sensors in order to track and guide the catheter and biopsy device towards the target region.
Additionally as discussed for claim 36 and claim 25, Acker teaches the catheter or similar device with position detector (Title and abstract) the position detector having at least two separate coils (Figs. 5A-5B and col.9 2nd ¶ to col. 10 1st ¶ and Figs.11-12 sensors wrapped around the tip of as catheter or elongated tools with separate conductive coils wounded and facing each other to allow precise positioning of the distal end of the tool with the wrapping performed in different fashions as designed). Additionally, Acker teaches the use of a sheath or protective coating above the coils (col.14 3rd ¶) therefore reading on the first EM sensor on the catheter including the first sensor disposed including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils and one of ordinary skill in the art would have also applied the same technique of positioning for the biopsy device as taught by Glossop as discussed above therefore reading on the second EM sensor including the second EM sensor including: a third conductive coil; a fourth conductive coil; and a second non-conductive material covering the third and fourth conductive coils. Additionally, Carmeli teaches within the same field of endeavor using catheter (Title and abstract and [0011]-[0013] with navigation of catheter) the use of sensor coils (Fig.2B and [0153] such as coils 227 and 228 or 229 and 224 as considered two sensor sets wherein coil 227 is clockwise and coil 228 is counterclockwise and facing each other and wherein coil 229 is clockwise and coil 224 is counterclockwise) teaching wherein the first coil and third conductive coil each have a clockwise orientation, and the second coil and fourth conductive coil each have a counterclockwise orientation as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the apparatus further comprises: the catheter includes a working channel configured to receive a biopsy tool, the biopsy tool including a second EM sensor disposed on a distal portion of the biopsy tool and formed of a third conductive coil, a fourth conductive coil, and a second non-conductive material covering the third and fourth conductive coils, wherein the third conductive coil has a clockwise orientation and the fourth conductive coil has a counterclockwise orientation, since one of ordinary skill in the art would recognize that using such EM sensors wound around the longitudinal axis of a catheter or elongated tool such as the biopsy tool at their distal tip with two electromagnetic coils wound on the sensor and facing each other across the longitudinal axis was known in the art with the conductor being covered with a non-conducting layer as taught by Acker and Glossop and since the sensors are presenting the coils as one wound clockwise and the other wound counter clockwise when unwrapped as taught by Carmeli. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Glossop, Acker and Carmeli teach navigation systems for catheter using magnetic sensors. The motivation would have been to provide sensors for positioning and orienting each of the different elongated medical tools for minimal invasive procedures with a small profile to allow to keep minimal the size of the medical tool, as suggested by Acker (col.3 5th ¶).
Regarding claim 44, Glossop teaches the catheter includes a working channel configured to receive an ablation probe as configured to be inserted through a working channel of the catheter for navigating the ablation probe and the catheter to a target location within the patient's airways (abstract [0028] “inserting a medical instrument into the catheter, thus bringing the medical instrument in proximity to the target” wherein the medical instrument is identified with an ablation probe “a radio frequency (RF) ablation device” advancing through a channel of the catheter ([0014]-[0016]) with the ablation probe including; a second EM sensor disposed on the distal portion of the biopsy device, ([0016]-[0018] including a coil system at the tip of the instrument), therefore teaching the first the first and second EM sensors in order to track and guide the catheter and ablation probe towards the target region.
Additionally as discussed for claim 36 and claim 25, Acker teaches the catheter or similar device with position detector (Title and abstract) the position detector having at least two separate coils (Figs. 5A-5B and col.9 2nd ¶ to col. 10 1st ¶ wrapped around the tip of as catheter or elongated tools with separate conductive coils wounded) with Carmeli and Lyu teaching as discussed above, the coil sensors wrapped around the instruments along their longitudinal axis of the distal parts and facing each other to allow precise positioning of the distal end of the tool with the wrapping performed in different fashions as designed. Additionally, Acker teaches the use of a sheath or protective coating above the coils (col.14 3rd ¶) therefore reading on the first EM sensor on the catheter including the first sensor disposed including: a first conductive coil; a second conductive coil; and a first non-conductive material covering the first and second conductive coils and one of ordinary skill in the art would have also applied the same technique of positioning for the locatable guide catheter as taught by Nevo as discussed above therefore reading on the second EM sensor including the second EM sensor including: a third conductive coil; a fourth conductive coil; and a second non-conductive material covering the third and fourth conductive coils.
Additionally, Carmeli teaches within the same field of endeavor using catheter (Title and abstract and [0011]-[0013] with navigation of catheter) the use of sensor coils (Fig.2B and [0153] such as coils 227 and 228 or 229 and 224 as considered two sensor sets wherein coil 227 is clockwise and coil 228 is counterclockwise and facing each other and wherein coil 229 is clockwise and coil 224 is counterclockwise) teaching wherein the first coil and third conductive coil each have a clockwise orientation, and the second coil and fourth conductive coil each have a counterclockwise orientation as claimed in clam 44.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the apparatus further comprises: the catheter includes a working channel configured to receive an ablation probe, the ablation probe including a second EM sensor disposed on a distal portion of the ablation probe and formed of a third conductive coil, a fourth conductive coil, and a second non-conductive material covering the third and fourth conductive coils, wherein the third conductive coil has a clockwise orientation and the fourth conductive coil has a counterclockwise orientation, since one of ordinary skill in the art would recognize that using such EM sensors wound around the longitudinal axis of a catheter or elongated tool such as the guidewire at their distal tip with two electromagnetic coils wound on the sensor and facing each other across the longitudinal axis was known in the art with the relative position of the adjacent coils as being overlapping or not with the neighboring coils as taught by Acker and Nevo and since one of ordinary skill in the art would recognize that using such EM sensors wound around the longitudinal axis of a catheter or elongated tool at their distal tip with two electromagnetic coils wound on the sensor and facing each other across the longitudinal axis was known in the art with the relative position of the adjacent coils as being overlapping or not with the neighboring coils as taught by Acker, Carmeli and Lyu and since the sensors are presenting the coils as one wound clockwise and the other wound counter clockwise when unwrapped as taught by Carmeli. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since Glossop, Acker and Carmeli teach navigation systems for catheter using magnetic sensors. The motivation would have been to provide sensors for positioning and orienting each of the different elongated medical tools for minimal invasive procedures with a small profile to allow to keep minimal the size of the medical tool, as suggested by Acker (col.3 5th ¶).
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop (USPN 20060184016 A1; Pub.Date 08/17/2006 ; Fil.Date 01/18/2006) in view of Nevo et al. (USPN 20130303878 A1; Pub.Date 11/14/2013; Fil.Date 01/19/2012) in view of Acker et al. (USPN 6253770 B1; Pat.Date 07/03/2001; Fil.Date 02/14/1997) in view of Carmeli et al. (USPN 20120302820 A1; Pub.Date 11/29/2012; Fil.Date 06/08/2012) in view of Lyu et al. (USPN 20110066029 A1; Pub.Date 03/17/2011; Fil.Date 09/11/2009) as applied to claim 25 and further in view of Eichler et al. (USPN 20120130230 A1; Pub.Date 05/24/2012; Fil.Date 11/19/2010) hereafter Eichler’2012.
Glossop, Nevo, Acker, Carmeli and Lyu teach a system as set forth above.
Glossop, Nevo, Acker, Carmeli and Lyu do not specifically teach a locking mechanism coupled to the catheter and configured to secure the locatable guide catheter within the working channel of the catheter as in claim 29.
However, Eichler’2012 teaches within the same field of endeavor of navigating a surgical device such a catheter (Title and abstract) the use of a locking system for locking the position of a guidewire with the lumen of a catheter (Figs.6a-6b button 210 pressed or depressed and [0046]) teaching a locking mechanism coupled to the catheter and configured to secure the locatable guide catheter within the working channel of the catheter as claimed for the purpose of advancing both the catheter and the guidewire within the patient (Figs.6a-6b).
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the apparatus further comprises: a locking mechanism coupled to the catheter and configured to secure the locatable guide catheter within the working channel of the catheter since one of ordinary skill in the art would recognize that using a pressure button to lock the guidewire within the lumen of the catheter was known in the art as taught by Eichler’2012. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since both Eichler’2012 and Glossop teach navigating catheters and guidewires within a patient. The motivation would have been to provide a simple manual mean for locking the guidewire in place within the catheter during the initial step of introducing the catheter within the patient body prior to deploy the guidewire to the target as suggested by Eichler’2012 ([0045]-[0046] and [0049]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop (USPN 20060184016 A1; Pub.Date 08/17/2006 ; Fil.Date 01/18/2006) in view of Nevo et al. (USPN 20130303878 A1; Pub.Date 11/14/2013; Fil.Date 01/19/2012) in view of Acker et al. (USPN 6253770 B1; Pat.Date 07/03/2001; Fil.Date 02/14/1997) in view of Carmeli et al. (USPN 20120302820 A1; Pub.Date 11/29/2012; Fil.Date 06/08/2012) in view of Lyu et al. (USPN 20110066029 A1; Pub.Date 03/17/2011; Fil.Date 09/11/2009) as applied to claim 25 and further in view of Jenkins et al. (USPN 20160015944 A1; Pub.Date 01/21/2016; priority Fil.Date 07/09/2014).
Glossop, Nevo, Acker, Carmeli and Lyu teach a system as set forth above. Regarding claim 33, as discussed above, Nevo teaches the coils being applied to the outside of the guidewire ([0014]).
Glossop, Nevo, Acker, Carmeli and Lyu do not specifically teach that the third and fourth conductive coils are directly printed on locatable guide as in claim 33.
However, Jenkins teaches the guidewire being made with a PTFE liner and that coil at the tip of guidewire can be either laser etched or printed directly on the guidewire ([0084]) therefore teaching the third and fourth conductive coils are directly printed on locatable guide as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the third and fourth conductive coils are directly printed on locatable guide since one of ordinary skill in the art would recognize that etching or printing coils on guidewire was known in the art as taught by Jenkins. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since both Jenkins and Glossop teach designing catheters and guidewires. The motivation would have been to provide the guidewire with implanted marker and/or coil sensor to preserve the size of the guidewire, as suggested by Jenkins
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Glossop (USPN 20060184016 A1; Pub.Date 08/17/2006 ; Fil.Date 01/18/2006) in view of Nevo et al. (USPN 20130303878 A1; Pub.Date 11/14/2013; Fil.Date 01/19/2012) in view of Acker et al. (USPN 6253770 B1; Pat.Date 07/03/2001; Fil.Date 02/14/1997) in view of Carmeli et al. (USPN 20120302820 A1; Pub.Date 11/29/2012; Fil.Date 06/08/2012) in view of Lyu et al. (USPN 20110066029 A1; Pub.Date 03/17/2011; Fil.Date 09/11/2009) as applied to claim 25 and further in view of Seter et al. (USPN 20130066194 A1; Pub.Date 03/14/2013; Fil.Date 09/14/2011).
Glossop, Nevo, Acker, Carmeli and Lyu teach a system as set forth above.
Glossop, Nevo, Acker, Carmeli and Lyu do not specifically teach the locatable guide catheter being at least partially formed of PTFE in claim 34.
However, Seter teaches within the same field of endeavor of navigation system for minimal invasive medical devices using a bronchoscope (title, abstract “bronchoscope” “catheter and guidewire and [0017] “ Medical devices, such as catheters, can be configured to perform various tracking, navigation, orientation and other location functions, provided such devices are configured to allow a positioning system to determine its position and/or orientation.” and Fig. 1) the use of PTFE for electrical insulation purposes (Fig. 7 and [0037] “ PTFE, and/or other appropriate materials may be included in cable 70 for electrical insulation purposes) for the use of electrical wires between the EM sensors and the signal processing system performing the navigation analysis.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that the apparatus further comprises: the locatable guide catheter is at least partially formed of polytetrafluoroethylene (PTFE) since one of ordinary skill in the art would recognize that using PTFE for electric cables along elongated medical devices between EM sensors and the navigation signal analysis system was known in the art as taught by Seter. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since both Seter and Glossop teach navigating catheters and guidewires using electromagnetic sensors within the patient while monitoring the breathing of the patient using an external motion sensor when using a bronchoscope. The motivation would have been to provide thermally and electrically flexible insulation for the electrical wires conducting the navigation signal along the elongated medical devices as suggested by Seter ([0037]).
Claims 35, 41 are rejected under 35 U.S.C. 103 as being unpatentable over Glossop (USPN 20060184016 A1; Pub.Date 08/17/2006 ; Fil.Date 01/18/2006) in view of Nevo et al. (USPN 20130303878 A1; Pub.Date 11/14/2013; Fil.Date 01/19/2012) in view of Acker et al. (USPN 6253770 B1; Pat.Date 07/03/2001; Fil.Date 02/14/1997) in view of Carmeli et al. (USPN 20120302820 A1; Pub.Date 11/29/2012; Fil.Date 06/08/2012) in view of Lyu et al. (USPN 20110066029 A1; Pub.Date 03/17/2011; Fil.Date 09/11/2009) as applied to claims 25 and 36 and further in view of Mueller (USPN 20070043288 A1; Pub.Date 02/22/2007; priority Fil.Date 09/01/2004).
Glossop, Nevo, Acker, Carmeli and Lyu teach a system as set forth above. Regarding claims 35 and 41, as discussed above, Nevo teaches the coils being applied to the outside of the guidewire and on the catheter ([0014]).
Glossop, Nevo, Acker, Carmeli and Lyu do not specifically teach that the third and fourth conductive coils are directly printed on the catheter as in claims 35 and 41.
However, Mueller teaches within the same field of endeavor of designing catheter (Title and abstract) the tip of the catheter as presenting coils (Fig.7) wherein the coils are deposited on the tip of the catheter ([0050]) therefore teaching the first and second conductive coils are directly printed on the catheter as claimed.
Therefore it would have been obvious for a person of ordinary skill in the art before the effective filling date of the invention to have modified the apparatus of Glossop as modified by Nevo, Acker, Carmeli and Lyu such that teaching the first and second conductive coils are directly printed on the catheter since one of ordinary skill in the art would recognize that printing/depositing coils directly on guidewire was known in the art as taught by Mueller. One of ordinary skill in the art would have expected that this modification could have been made with predictable results since both Mueller and Glossop teach designing catheters for medical applications. The motivation would have been to provide the catheter with implanted marker and/or coil sensor to preserve the size of the catheter, as suggested by Mueller (Fig.7 and [0050]).
Conclusion
THIS ACTION IS MADE FINAL. 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 PATRICK M MEHL whose telephone number is (571)272-0572. The examiner can normally be reached Monday-Friday 9AM-6PM.
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/PATRICK M MEHL/ Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798
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