DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The proposed reply filed on 08/13/2026 has been entered. Claims 1-4, 7, 10, 12-14, and 16-20 remain pending in the current application.
Claim Objections
Claim 17 is objected to because of the following informalities: claim 17 recites the limitation “wherein the magnetic permeability of the reinforcement” should read “wherein a magnetic permeability of the reinforcement”. Appropriate correction is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 1, 4, 7, 10, and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. (US 2021/0275136) in the view Crowley et al. (US 2012/0245457) and Parchak et al. (US 2008/0306380).
Regarding claim 1, Stigall teaches an intraluminal imaging device, comprising (para. 0056; an ICE imaging system 100 ):
a flexible elongate member comprising a tubular wall defining a primary lumen (para. 0061; The flexible elongate member 108 can be composed of any suitable material, such as polyether block amides. Polyether block amides are commonly manufactured under the tradename Pebax®. The distal portion 104 and the proximal portion 106 are tubular in shape and may include a primary lumen.);
an imaging core coupled to a distal portion of the flexible elongate member (paras. 0061 and 0064; The tip assembly 102 and the flexible elongate member 108 are shaped and sized for insertion into vessels of a patient body. The tip assembly 102 includes an imaging core 562 encased in a tip member 560. For example, the imaging core 562 is a planar element. The tip assembly 102 can include an alignment portion (not shown) shaped to facilitate alignment during manufacturing, as described in greater detail herein. The imaging core 562 is connected to an electrical cable 566 via an electrical interconnection 564. The electrical cable 566 extends longitudinally along the flexible elongate member 108. );
a handle coupled to a proximal portion of the flexible elongate member (para. 0056; The ICE device 110 includes a tip assembly 102, a flexible elongate member 108, and a handle 120. The flexible elongate member 108 includes a distal portion 104 and a proximal portion 106. The distal end of the distal portion 104 is attached to the tip assembly 102. The proximal end of the proximal portion 106 is attached to the handle 120 for example, by a resilient strain reliever 112, for manipulation of the ICE device 110 and manual control of the ICE device 110.);
a first plurality of wires extending from the imaging core through the primary lumen to the proximal portion of the flexible elongate member (paras. 0061 and 0064-0065; The distal portion 104 and the proximal portion 106 are tubular in shape and may include a primary lumen and one or more pullwire lumens extending longitudinally along the flexible elongate member 108. The primary lumen is sized and shaped to accommodate an electrical cable interconnecting the tip assembly 102 and the connector 124 for transferring echo signals obtained from the transducer elements. The imaging core 562 is connected to an electrical cable 566 via an electrical interconnection 564. The electrical cable 566 extends longitudinally along the flexible elongate member 108. The electrical cable 566 may include one or more cables and/or one or more wires formed into cables. In certain embodiments, the one or more cables or wires are encased or surrounded at least partially along their length with a heat shrink tubing. The examiner notes that an electrical cable surrounded by a heat shrink tubing enclosing wires extending from the imaging core through the primary lumen to the proximal end (handle));
a shield positioned within the primary lumen and extending along a length of the flexible elongate member from the distal portion to the proximal portion, wherein the shield is separate from an inner surface of the tubular wall, wherein the shield surrounds the plurality of wires (paras. 0061 and 0064-0065; The electrical cable 566 may include one or more cables and/or one or more wires formed into cables. In certain embodiments, the one or more cables or wires are encased or surrounded at least partially along their length with a heat shrink tubing. The heat shrink tubing is typically a polymeric material. An ideal polymeric material is polyethylene terephthalate (PET). The heat shrink tubing material may be manufactured using an extrusion process. Ideally the tubing is manufactured such that the expanded ID clears width of the cables to be threaded there through, and the shrunked ID is such that it forms a interference fit with the cables threaded there through. The examiner notes that the wires extending from the distal tip are extended through the primary lumen and shielded using a heat shrinking tube).
However, Stigall fails to explicitly teach one or more electromagnetic position sensors coupled to the distal portion of the flexible elongate member, the one or more electromagnetic position sensors having a known position relative to at least one of the imaging core, the distal portion of the flexible elongate member, or another electromagnetic position sensor of the one or more electromagnetic position sensors, second plurality of wires extending from each of the one or more electromagnetic position sensors through the primary lumen to the proximal portion of the flexible elongate member; the shield having has a magnetic permeability between about 80,000 and about 400,000.
Crowley, in the same field of endeavor, teaches one or more electromagnetic position sensors coupled to the distal portion of the flexible elongate member, the one or more electromagnetic position sensors having a known position relative to at least one of the imaging core, the distal portion of the flexible elongate member, or another electromagnetic position sensor of the one or more electromagnetic position sensors (fig. 12, paras. 0027 and 0076; hand manipulable device carrying at least two ultrasound transducers and an electromagnetic position function operably oriented with respect to at least one transducer near a distal portion of the imaging device. Coaxial cable 157 may be connected in series or in parallel, as previously taught to both transducer 151 and coil 153, which may be placed axially now that rotary position control is afforded by the multiifilar driveshaft. The addition of a coil axially spaced in relation to an existing transducer is very economical, and practical, made operational by various applications of the principles of the invention. The examiner notes that the electromagnetic position sensor is coupled to the distal end of the device at a known position relative to the imaging transducer.);
plurality of wires extending from each of the one or more electromagnetic position sensors through the primary lumen to the proximal portion of the flexible elongate member (paras. 0066 and 0076; Transducer 151 is shown with coil 153 across, in parallel with transducer 151, and leads connected to coaxial cable 157. Multifilar driveshaft is comprised of at least two layers of counterwound wires to provide 1:1 torque and has a hollow lumen to accommodate coaxial cable 157 through its length. Coaxial cable 157 may be connected in series or in parallel, as previously taught to both transducer 151 and coil 153, which may be placed axially now that rotary position control is afforded by the multiifilar driveshaft. The examiner notes that a cable comprising plurality of wires of the electromagnetic position sensor extends through the lumen of shaft.); and
wherein the shield surrounds the plurality of wires (para. 0063; practical constructions to produce and receive acoustic information and receive electromagnetic position information using a coil form structure mounted relative thereto, FIG. 10a-b show ways to conduct the usable signals over a single transmission line, in this case a shielded, coaxial transmission line that is preferred where low noise and resistance to radiofrequency ingress is desired. The examiner notes that the cable, including the plurality of wires from the transducer and the position sensor, is shielded to reduce electromagnetic noise.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the ICE catheter of Stigall to include the electromagnetic position sensor and shielded cable extending through the lumen of the imaging device of Crowley, because such modification would allow the user to monitor the device position and orientation as it is being advanced through the region of interest, which would improve device guidance. Additionally, using a shielded cable carrying signals from the transducer and the electromagnetic device would cancel electromagnetic interference and thereby preserving image quality as disclosed within Crowley in paras. 0025 and 0029.
However, Stigall in the view of Crowley fail to explicitly teach the shield has a magnetic permeability between about 80,000 and about 400,000.
Parchak, in the same field of endeavor, teaches shield has a magnetic permeability between about 80,000 and about 400,000 (paras. 0034-0035; In designing system 20 (and likewise other types of medical probes that must operate in an environment of strong magnetic fields), care should be taken to avoid picking up interference in the wires carrying the signals from the sensors at distal end 34 of catheter 22 to the amplifier circuits in connector assembly 28 and/or in console 24. Field generator coils 38 radiate strong fields in order to enable the position tracking system to achieve sufficient signal/noise ratio, with very small sensor coils in the catheter, to provide accurate position measurements. Long wires leading from the sensor coils to the proximal end of the catheter pass through these strong fields, and any loops in the wires will pick up interference. Nevertheless, given the strength of the magnetic fields and the weakness of the signals output by sensor 36, even minimal pickup of the magnetic fields at the input to the amplifiers can result in serious errors in the position coordinates of distal end 34. Embodiments of the present invention address this problem by incorporating a material with high magnetic permeability (i.e., with relative permeability of 1000 or greater) in connector assembly 28, as described in detail hereinbelow. The inventors have found that Mu-metal gives good results in this regard. This sort of shielding is important particularly in protecting position signals from magnetic interference, but it may also be used, additionally or alternatively, in protecting signals associated with functional elements of other types. Furthermore, although the present embodiment relates specifically to a cardiac catheter, the principles of the present invention may similarly be applied to other types of medical probes.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shield of Stigall in the view of Crowley to include a shield made of high magnetic permeability (mu-metal) of Parchak, because such modification would eliminate serious errors in the position data by protecting position signals from magnetic interference as disclosed within Parchak in para. 0035.
Regarding claim 4, Stigall teaches intraluminal imaging device of claim 1, however, fails to explicitly teach wherein the shield comprises at least one of a mu-metal or a metallic glass alloy.
Parchak, in the same field of endeavor, teaches shield comprises at least one of a mu-metal or a metallic glass alloy (paras. 0034-0035; In designing system 20 (and likewise other types of medical probes that must operate in an environment of strong magnetic fields), care should be taken to avoid picking up interference in the wires carrying the signals from the sensors at distal end 34 of catheter 22 to the amplifier circuits in connector assembly 28 and/or in console 24. Field generator coils 38 radiate strong fields in order to enable the position tracking system to achieve sufficient signal/noise ratio, with very small sensor coils in the catheter, to provide accurate position measurements. Long wires leading from the sensor coils to the proximal end of the catheter pass through these strong fields, and any loops in the wires will pick up interference. Nevertheless, given the strength of the magnetic fields and the weakness of the signals output by sensor 36, even minimal pickup of the magnetic fields at the input to the amplifiers can result in serious errors in the position coordinates of distal end 34. Embodiments of the present invention address this problem by incorporating a material with high magnetic permeability (i.e., with relative permeability of 1000 or greater) in connector assembly 28, as described in detail hereinbelow. The inventors have found that Mu-metal gives good results in this regard. This sort of shielding is important particularly in protecting position signals from magnetic interference, but it may also be used, additionally or alternatively, in protecting signals associated with functional elements of other types. Furthermore, although the present embodiment relates specifically to a cardiac catheter, the principles of the present invention may similarly be applied to other types of medical probes.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shield of Stigall in the view of Crowley to include a shield made of high magnetic permeability (mu-metal) of Parchak, because such modification would eliminate serious errors in the position data by protecting position signals from magnetic interference as disclosed within Parchak in para. 0035.
Regarding claim 7, Stigall teaches the intraluminal imaging device of claim 1, wherein the tubular wall defines an outer surface of the flexible elongate member (para. 0061; The flexible elongate member 108 can be composed of any suitable material, such as polyether block amides. Polyether block amides are commonly manufactured under the tradename Pebax®. The distal portion 104 and the proximal portion 106 are tubular in shape and may include a primary lumen and one or more pullwire lumens extending longitudinally along the flexible elongate member 108. The primary lumen is sized and shaped to accommodate an electrical cable interconnecting the tip assembly 102 and the connector 124 for transferring echo signals obtained from the transducer elements).
Regarding claim 10, Stigall teaches the intraluminal imaging device of claim 1, however, fails to explicitly teach further comprising: a multiplexer positioned within the handle or the proximal portion of the flexible elongate member, the multiplexer configured to remove electromagnetically induced noise from a position sensor signal carried by the second plurality of wires.
Crowley, in the same field of endeavor, disclose a multiplexer positioned within the handle or the proximal portion of the flexible elongate member, the multiplexer configured to remove electromagnetically induced noise from a position sensor signal carried by the second plurality of wires (paras. 0057, 0071 and 0075; frequency division multiplexing of the signals may be effective to separate the two desired signals without undue interference therebetween. As smaller devices are used and more sensitive receivers are desired, this isolation, which may be in the order of 40 dB or more, may be insufficient. Therefore an additional measure is taken to assure no interference between ultrasonic and low frequency AC signals, by use of time division sharing of the single transmission line. Time division multiplexing of image information and P&O information is thus accomplished with this simple timing expedient. The examiner notes that the handle of the catheter comprise processing circuitry that comprise a frequency multiplexer and time division multiplexer to process the signals received form the electromagnetic coils and the transducer to remove interference.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the ICE catheter of Stigall to include the multiplexer of Crowley, because such modification would allow to process the signals using timing slots and ensure no interference is present in the data, which will allow the generation of noise free images and accurate position data as disclosed within Crowley in para. 0070.
Regarding claim 16, Stigall teaches the intraluminal imaging device of claim 1, wherein the flexible elongate member further comprises a reinforcement embedded within the tubular wall (para. 0067; the flexible elongate member 108 may include a lined variable braided enforcement layer to provide flexibility and kink resistance as described in greater detail herein.), wherein the shield and the reinforcement are separate from one another (para. 0061 and 0065; The flexible elongate member 108 can be composed of any suitable material, such as polyether block amides. Polyether block amides are commonly manufactured under the tradename Pebax®. The distal portion 104 and the proximal portion 106 are tubular in shape and may include a primary lumen and one or more pullwire lumens extending longitudinally along the flexible elongate member 108. The primary lumen is sized and shaped to accommodate an electrical cable interconnecting the tip assembly 102 and the connector 124 for transferring echo signals obtained from the transducer elements. The electrical cable 566 may include one or more cables and/or one or more wires formed into cables. In certain embodiments, the one or more cables or wires are encased or surrounded at least partially along their length with a heat shrink tubing. The examiner notes that the cable is shielded by a heat shrinking tube and is disposed inside the primary lumen, thus it is separate from the walls of the flexible elongated member reinforcement).
Regarding claim 17, modified Stigall teaches the intraluminal imaging device of claim 16, wherein the magnetic permeability of the reinforcement is lower than the magnetic permeability of the shield (Parchak, paras. 0035-0036; incorporating a material with high magnetic permeability (i.e., with relative permeability of 1000 or greater) in connector assembly 28, as described in detail hereinbelow. A Mu-metal shield 46 slides over and encloses receptacle 44, and a shell 48 slides over and covers the shield, resulting in the appearance shown in FIG. 3. Shell 48 comprises a suitable insulating material, typically a plastic, such as polybutylene terephthalate (PBT).).
The examiner notes that Stigall teaches the catheter shaft 3100 further includes a braided layer 3104 embedded within the tubular wall 3102. The braided layer 3104 includes a distal portion 3212, a proximal portion 3216, and a transition portion 3214 between the distal portion 3212 and the proximal portion 3216. The braided layer 3104 can be composed of any suitable material and geometry. For example, the braided layer 3104 may include stainless steel flat wires, which may provide optimal usage of radial space and additional strength (para. 0113). It is known that the magnetic permeability of mu-metal is much higher than stainless steel flat wires, thus, modified Stigall teaches that the magnetic permeability of the shield is higher than the reinforcement braid. Doing so would improve electromagnetic interference reduction and position sensing accuracy.
Regarding claim 18, Stigall teaches the intraluminal imaging device of claim 16, wherein the reinforcement comprises a cylindrical braid (para. 0113; the catheter shaft 3100 further includes a braided layer 3104 embedded within the tubular wall 3102. The braided layer 3104 includes a distal portion 3212, a proximal portion 3216, and a transition portion 3214 between the distal portion 3212 and the proximal portion 3216. The braided layer 3104 can be composed of any suitable material and geometry. For example, the braided layer 3104 may include stainless steel flat wires, which may provide optimal usage of radial space and additional strength).
Regarding claim 19, modified Stigall teaches the intraluminal imaging device of claim 1, however, fails to explicitly teach wherein the second plurality of wires comprises a twisted pair of wires.
Parchak, in the same field of endeavor, teaches plurality of wires comprises a twisted pair of wires (para. 0034; To minimize this interference, the coils are typically connected to the amplifier circuits by twisted pairs of thin wires running through the catheter with a high twist rate. The wires are untwisted and separated as close as possible to the input pins of the amplifiers in order to minimize the area that can pick up the electromagnetic field.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the cables of Stigall in the view of Crowley to include a twisted wires connecting the electromagnetic sensors to the amplifier of Parchak, because such modification would minimize electromagnetic interference by minimizing the area that can pick up the electromagnetic field as disclosed within Parchak in para. 0034.
Regarding claim 20, Stigall teaches the intraluminal imaging device of claim 1, wherein the flexible elongate member comprises a catheter shaft configured to be advanced through a blood vessel and to a heart (para. 0058; a physician or a clinician advances the flexible elongate member 108 into a vessel within a heart anatomy.), wherein the imaging core comprises an ultrasound transducer array (para. 0091; the imaging core 562 includes an array of ultrasound transducer elements and is positioned such that ultrasonic waves propagates towards and through the distal flat top inner wall 1826 and the distal flat top outer wall 1722 as shown by the dashed arrows and described in greater details herein.), and wherein the intraluminal imaging device is an intracardiac echocardiography (ICE) catheter (para. 0056; The ICE device 110 includes a tip assembly 102, a flexible elongate member 108, and a handle 120.).
Claim(s) 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. (US 2021/0275136) in the view Crowley et al. (US 2012/0245457) and Parchak et al. (US 2008/0306380) in further view of Khait et al. (US 2013/0080119).
Regarding claim 12, modified Stigall teaches the intraluminal imaging device of claim 13, wherein the multiplexer is configured to perform time-division multiplexing with a time slot (Crowley, paras.0071-0074; Therefore an additional measure is taken to assure no interference between ultrasonic and low frequency AC signals, by use of time division sharing of the single transmission line. Timing diagrams shown herein are not to scale, emphasis being placed on relationship of events. Time division multiplexing of image information and P&O information is thus accomplished with this simple timing expedient).
However, fails to explicitly teach the immediately preceding time slot and the current time slot each have a time slot length between about 0.25 microseconds and about 1.0 microsecond.
Khait, in the same field of endeavor, teaches the immediately preceding time slot and the current time slot each have a time slot length between about 0.25 microseconds and about 1.0 microsecond (para. 0038; Clock pulses originating from a master clock of the in-vivo device may be used to count time units (a time `unit` may equal to, e.g., 1 microsecond) relative to a reference time. Any synchronization bit or group of bits that is/are contained in a data frame (e.g., prefix data, suffix data, etc.) that is transmitted by the in-vivo device may be used by a receiver (e.g., data recorder) to restore the clock pulses originating from the in-vivo device. Prefix data or suffix data, or both data, have the same relative location within each working cycle ((they do not change from frame to frame). Therefore, such data may be used to obtain synchronization. The restored clock pulses may be used by the receiver to count time by using the same time units and relative to the same reference time. Based on the time counting, the LSS may start transmitting a localization signal when the time count has a first value; e.g., Count1, and terminate the transmission when the time count has a second value, e.g., Count2 (where Count2>Count1).).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the time division multiplexed time slots of Stigall in the view of Crowley and Parchak with 1 microsecond time slot of Khait, because such modification would allow a fast update rate, sufficient signal acquisition time, and minimize cross channel interference.
Regarding claim 13, modified Stigall teaches the intraluminal imaging device of claim 10, however, fails to explicitly teach wherein to remove the noise, the multiplexer is further configured to subtract a first portion of the position sensor signal in an immediately preceding time slot from a second portion of the position sensor signal in a current time slot.
Khait, in the same field of endeavor, teaches wherein to remove the noise, the multiplexer is further configured to subtract a first portion of the position sensor signal in an immediately preceding time slot from a second portion of the position sensor signal in a current time slot (para. 0143; Starting at step 840, cancelling out the electromagnetic interference signal from the (noisy) alternating output signal may include sampling, using sampling specifics, a first portion of the alternating signal (e.g., in the positive portion of the alternating/output signal) during a first sampling window/period to obtain a first set of (e.g., positive) sample values (at step 840), calculating a first (e.g., positive) number, N.sub.P, by adding up the first set of sample values (at step 850); sampling, using the sampling specifics, a second portion of the alternating signal (e.g., in the negative portion of the alternating/output signal) during a second sampling window/period to obtain a second set of (e.g., negative) sample values (at step 860); calculating a second (e.g., negative) number, N.sub.N, by adding up the second set of sample values (at step 870), and, at step 880, calculating a representative number, N.sub.R, for example by subtracting the second, or negative, number N.sub.N from the first, or positive, number N.sub.P (e.g., N.sub.R=N.sub.P-N.sub.N). The representative number N.sub.R may represent, or indicate, the genuine (interference free) alternating signal, and thus it may reliably represent the location and/or orientation of the in-vivo device.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the time division multiplexer of Stigall in the view of Crowley and Parchak to include the subtraction of signals of adjacent samples of Khait, because such modification would allow the electromagnetic interference signals to be canceled out and generating an accurate and reliable representation of the location and orientation of the catheter using this common noise cancelation technique as disclosed within Khait in para. 0143.
Regarding claim 14, modified Stigall teaches the intraluminal imaging device of claim 13, wherein the multiplexer is further configured to receive the position sensor signal as an analog input signal and to output an analog output signal (Crowley, paras. 0070-0074; the examiner notes that the time division multiplexer receives analog data from the electromagnetic sensor and outputs analog data without converting the analog output to digital output to enable further processing and filtering.).
Claim(s) 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. (US 2021/0275136) in the view Crowley et al. (US 2012/0245457) and Parchak et al. (US 2008/0306380) in further view of Dietz et al. (US 2010/0280316).
Regarding claim 2, modified Stigall teaches the intraluminal imaging device of claim 1, however, fails to explicitly teach wherein the shield comprises a cylindrical braid.
Dietz, in the same field of endeavor, teaches shield comprises a cylindrical braid (para. 0182; The shield layer 98 may be used to shield components internal to the shield layer 98 (e.g., the electrical interconnection member 104) from external electrical noise. The shield layer 98 may be in the form of a double served wire shield or braid.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shield of a catheter of Stigall in the view of Crowley and Parchak with braided shield of Dietz, because braided shields are well known for providing a 360 degree electromagnetic shielding while maintaining flexibility, bendability, torque transmission, and durability.
Regarding claim 3, modified Stigall teaches the intraluminal imaging device of claim 1, however, fails to explicitly teach wherein the shield comprises a coil.
Dietz, in the same field of endeavor, teaches shield comprises a coil (para. 0182; The shield layer 98 may be used to shield components internal to the shield layer 98 (e.g., the electrical interconnection member 104) from external electrical noise. The shield layer 98 may be in the form of a double served wire shield or braid.).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the shield of a catheter of Stigall in the view of Crowley and Parchak with coil shield of Dietz, because shields comprising coils are known to be used for electromagnetic shielding and thus changing the mu metal shield with a shield comprising coil is a design choice.
Response to Arguments
Applicant’s arguments with respect to claims 35 USC 103 rejection in light of the amendments 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.
The applicant argues that Crowley fails to disclose a flexible elongated member comprising a tubular wall defining a primary lumen and shield positioned within the primary lumen and extending along a length of the flexible elongate member from the distal portion to the proximal portion, wherein the shield is separate from an inner surface of the tubular wall. The examiner respectfully disagrees. Crowley teaches, in paragraph 0076, a driveshaft comprising a distal and proximal portion that defines a hollow lumen, the hollow lumen is shaped and sized to accommodate a shielded coaxial transmission line cable for connecting the ultrasound transducer and the position sensor signals to the processor. The cable is shielded for minimizing electromagnetic interference. Thus, Crowley teaches a flexible elongated member comprising a tubular wall defining a lumen and a shield separate from the tubular wall and extending inside the lumen of the elongated member.
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 ZAINAB M ALDARRAJI whose telephone number is (571)272-8726. The examiner can normally be reached Monday-Thursday7AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carey Michael can be reached at (571) 270-7235. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
