DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment, filed 01/05/2026, has been entered. The examiner notes claims 1, 3-9, 11-12, 14-16, 18, 24-26, 29-31, 35, and 124-125 are pending.
Response to Arguments
Applicant’s arguments, see Remarks pages 6-8, filed 01/05/2026, with respect to the rejection(s) of claim(s) 1, 3-9, 11-12, 14-16, 18, 24-26, 29-31, 35, and 124-125 under 35 USC 103 have been fully considered and are persuasive. The examiner agrees that the prior art references used in the previous office action fail to teach the amended limitation. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Burkett (US 20160058382 A1).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-9, 11-12, 14-16, 18, 29, 31, 35, and 124-125 are rejected under 35 U.S.C. 103 as being unpatentable over Burkett (US 20140005561 A1, hereafter as B2014) in view of Schwager (US 5916177 A) and Burkett (US 20160058382 A1, hereafter as B2016].
Regarding claim 1, B2014 teaches a guidewire comprising:
a connector tube [Fig. 19 Item 252] extending from a proximal end of the guidewire the connector tube comprising a tube wall and a lumen extending therethrough [see Fig. 19];
a core wire [Fig. 19 Item 254];
a sensor assembly comprising:
a sensor [Fig. 2 Item 112]; and
a sensor housing [Fig. 2 Item 106] positioned over the sensor; and
an insulator portion [Fig. 19 Item 266] surrounding at least a portion of the connector tube [Fig. 19 Item 252] and extending proximally from the sensor housing, the insulator portion having a proximal end and a distal end [see Fig. 19].
B2014 teaches a connector tube [Fig. 19 Item 252] and a core wire [Fig. 19 Item 254], but fails to teach the core wire comprises a proximal end positioned distal of a distal end of the connector tube.
Schwager teaches a core wire [Fig. 2 Item 52] comprising a proximal end [Fig. 2 Item 53] positioned distal of a distal end [Fig. 2 Item 43] of the connector tube [Fig. 2 Item 41].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of B2014 and incorporate the teachings of Schwager to include the core wire comprises a proximal end positioned distal of a distal end of the connector tube. Doing so configures the apparatus with a robust connection point, allowing for signal transmission or power delivery, and enhancing the overall torquability and pushability of the guidewire at a desired position.
The combination of B2014 and Schwager teach a sensor housing, connector tube, and core wire, but fail to specifically teach at least a portion of the sensor housing positioned between the distal end of the connector tube and the proximal end of the core wire.
B2016 teaches at least a portion of the sensor housing [0043 “…a housing 124 containing component 108”, Fig. 3 Item 124] positioned between the distal end of the connector tube [Fig. 3 Item 126, the distal end being interpreted as the rightmost end] and the proximal end of the core wire [Fig. 3 Item 128, proximal end being interpreted as leftmost end].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of B2014 and Schwager and incorporate the teachings of B2016 to include at least a portion of the sensor housing positioned between the distal end of the connector tube and the proximal end of the core wire. Doing so configures the apparatus to provide a housing location that aids the prevention of direct transfer of mechanical forces to the sensor, it thus reducing drift, noise, and inaccurate measurements caused by deformation of the core wire and/or connector tube.
Regarding claim 3, B2014, Schwager, and B2016 teach the guidewire of claim 1, wherein the insulator portion [B2014 Fig. 19 Item 266] is configured to expose at least one conductive section of the connector tube [B2014 Fig. 19 Item 252].
Regarding claim 4, B2014, Schwager, and B2016 teach the guidewire of claim 3, wherein the at least one conductive section comprises a first conductive section [B2014 Fig. 19 Item 270] and a second conductive section [B2014 Fig. 19 Item 264], the second conductive section being spaced apart from the first conductive section [See B2014 Fig. 19, separated by Item 266 and a gap (unlabeled)].
Regarding claim 5, B2014, Schwager, and B2016 teach the guidewire of claim 4, wherein the first conductive section [B2014 Fig. 19 Item 270] is located at the proximal end of the guidewire and the second conductive section [B2014 Fig. 19 Item 264] is located distal of the first conductive section [see Burkett Fig. 19].
Regarding claim 6, B2014, Schwager, and B2016 teach the guidewire of claim 5, wherein the second conductive section [B2014 Fig. 19 Item 264] is positioned between the proximal end of the insulator portion [B2014 Fig. 19 Item 266] and the distal end of the insulator portion [B2014 Fig. 19 Item 260].
Regarding claim 7, B2014, Schwager, and B2016 teach the guidewire of claim 1, wherein the sensor is a pressure sensor [B2014 0056 “…the component 112 is a pressure sensor…”].
Regarding claim 8, B2014, Schwager, and B2016 teach the guidewire of claim 1, further comprising a coil portion [B2014 0063 “…the conductive portions 132, 134, and 136 are formed of a conductive material and are portions of a hypotube, a coil, and/or combinations thereof…”, B2014 Fig. 3 Items 132, 134, and 136] at least partially surrounding the core wire [B2014 Fig. 3 Item 118, 0059 “…section 118 is a section of a core wire…”].
Regarding claim 9, B2014, Schwager, and B2016 teach the guidewire of claim 8, wherein the insulator portion [B2014 Fig. 3 Items 138, 140, and 142] and the coil portion [B2014 0063 “…the conductive portions 132, 134, and 136 are formed of a conductive material and are portions of a hypotube, a coil, and/or combinations thereof…”, B2014 Fig. 3 Items 132, 134, and 136] have a same outer diameter [see B2014 Fig. 19].
Regarding claim 11, B2014, Schwager, and B2016 teach guidewire of claim 1, wherein the core wire [Schwager Fig. 2 Item 52] comprises a reduced diameter portion [See Schwager Fig. 2 Item 52 wherein the shaft has a flared end 53].
Regarding claim 12, B2014, Schwager, and B2016 teach the guidewire of claim 1, wherein the sensor [B2014 Fig. 2 Item 112] is coaxial with the core wire [B2014 Fig. 2 Item 118].
Regarding claim 14, B2014, Schwager, and B2016 teach the guidewire of claim 1, further comprising a wire lead [B2014 Fig. 19 Item 256] extending from the sensor [B2014 Fig. 2 Item 112, 0061 “…one or more electrical conductors that extend along the length of the flexible elongate member 102 and are electrically coupled to the component 112”] toward the proximal end of the guidewire, the wire lead at least partially extending through the lumen of the connector tube [See B2014 Fig. 19].
Regarding claim 15, B2014, Schwager, and B2016 teach the guidewire of claim 14, wherein the wire lead is concentrically [B2014 0070 “the portion 180 of the conductor 178 is wrapped at least partially around the tubular member 176 such that the soldering or other electrically coupling can be performed away from the opening of the tubular member 176…”] sealed to a proximal end of the connector tube to prevent fluid from flowing proximally to the proximal end of the guidewire [B2014 0087 “all internal gaps between a conductive bands/insulating spacers and the insulating tubular member or support structure below is filled with adhesive. Such an approach serves to eliminate any internal fluid pathways that may create a bridging effect and ensures that all components are fixedly secured to one another such that they won't mechanically shift, slip, and/or rotate relative to other components”].
Regarding claim 16, B2014 teaches a pressure guidewire comprising:
an outer tube [Fig. 3 Item 114] comprising a sensor housing [Fig. 2 Item 106, 0056 “…component 112 is positioned within the distal portion 107 of the flexible elongate member 106…”] and a coil portion [Fig 3 Items 132, 134, and 136, 0063 “…the conductive portions 132, 134, and 136 are formed of a conductive material and are portions of a hypotube, a coil, and/or combinations thereof…”];
connector tube [Fig. 19 Item 252] positioned radially inward of the outer tube, the connector tube comprising a tube wall and a lumen extending therethrough [see Fig. 19];
a core wire [Fig. 19 Item 254] positioned radially inward of the outer tube and longitudinally spaced apart from a distal end of the connector tube [see Fig. 2, 0060 “…the section 118 extends proximally from connection portion 114 a distance 126…”],
a pressure sensor assembly comprising a pressure sensor [Fig. 2 Item 112, 0056 “…the component 112 is a pressure sensor…”] and a pressure wire lead [Fig. 9 Item 256] extending from the pressure sensor toward a proximal end of the pressure guidewire [0061 “…one or more electrical conductors that extend along the length of the flexible elongate member 102 and are electrically coupled to the component 112”], the pressure sensor being distal of the distal end of the connector tube [see Fig. 2], the pressure wire lead at least partially extending through the lumen of the connector tube [see Fig. 19]; and
a distal tip [Fig. 2 Item 108] at a distal end of the outer tube.
B2014 teaches a core wire and a connector tube, but fails to teach a proximal end of the core wire is positioned distal of the distal end of the connector tube, and the core wire comprising a reduced diameter portion.
Schwager teaches a proximal end [Fig. 2 Item 53] of the core wire [Fig. 2 Item 52] is positioned distal of the distal end [Fig. 2 Item 43] of the connector tube [Fig. 2 Item 41], and
the core wire comprising a reduced diameter portion [See Fig. 2 Item 52 wherein the shaft has a flared end 53].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of B2014 and incorporate the teachings of Schwager to include a proximal end of the core wire is positioned distal of the distal end of the connector tube, and the core wire comprising a reduced diameter portion. Doing so configures the apparatus with a robust connection point, allowing for signal transmission or power delivery, and enhancing the overall torquability and pushability of the guidewire at a desired position.
The combination of B2014 and Schwager teach a sensor housing, connector tube, and core wire, but fail to specifically teach at least a portion of the sensor housing positioned between the distal end of the connector tube and the proximal end of the core wire.
B2016 teaches at least a portion of the sensor housing [0043 “…a housing 124 containing component 108”, Fig. 3 Item 124] positioned between the distal end of the connector tube [Fig. 3 Item 126, the distal end being interpreted as the rightmost end] and the proximal end of the core wire [Fig. 3 Item 128, proximal end being interpreted as leftmost end].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of B2014 and Schwager and incorporate the teachings of B2016 to include at least a portion of the sensor housing positioned between the distal end of the connector tube and the proximal end of the core wire. Doing so configures the apparatus to provide a housing location that aids the prevention of direct transfer of mechanical forces to the sensor, it thus reducing drift, noise, and inaccurate measurements caused by deformation of the core wire and/or connector tube.
Regarding claim 18, B2014, Schwager, and B2016 teach the pressure guidewire of claim 16, wherein the pressure wire lead is concentrically [B2014 0070 “the portion 180 of the conductor 178 is wrapped at least partially around the tubular member 176 such that the soldering or other electrically coupling can be performed away from the opening of the tubular member 176…”] sealed to a proximal end of the connector tube to prevent fluid from flowing proximally to the proximal end of the pressure guidewire [B2014 0087 “all internal gaps between a conductive bands/insulating spacers and the insulating tubular member or support structure below is filled with adhesive. Such an approach serves to eliminate any internal fluid pathways that may create a bridging effect and ensures that all components are fixedly secured to one another such that they won't mechanically shift, slip, and/or rotate relative to other components”].
Regarding claim 29, B2014, Schwager, and B2016 teach the pressure guidewire of claim 16, wherein the outer tube further comprises an insulator portion [B2014 Fig. 19 Item 266] extending proximally of the coil portion [B2014 Fig. 19 Item 264, 0063 “…the conductive portions 132, 134, and 136 are formed of a conductive material and are portions of a hypotube, a coil, and/or combinations thereof…”].
Regarding claim 31, B2014, Schwager, and B2016 teach the pressure guidewire of claim 16, wherein the distal tip [Schwager Fig. 2 Item 51] is joined to the coil portion [Schwager Fig. 2 Item 48], col. 5 lns. 39-41].
Regarding claim 35, B2014, Schwager, and B2016 teach the pressure guidewire of claim 16, wherein the outer tube is configured to expose at least a first conductive section [B2014 Fig. 19 Item 270] of the connector tube and a second conductive section [B2014 Fig. 19 Item 264] of the connector tube, the second conductive section being spaced apart from the first conductive section [see B2014 Fig. 19].
Regarding claim 124, B2014, Schwager, and B2016 teach the guidewire of claim 8, wherein the sensor housing [B2014 Fig. 2 Item 106] is in contact with the connector tube [B2014 Fig. 19 Item 252] and the coil portion [B2014 Fig. 3 Items 132, 134, and 136] is in contact with the sensor housing, each of the connector tube [B2014 0085 “…the conductive element 270 is advanced distally along the tubular member 252…”], the sensor housing [B2014 0056”…the flexible elongate member 106 comprises a stainless steel hypotube…”], and the coil portion [B2014 0063 “…the conductive portions 132, 134, and 136”] comprising a conductive material.
Regarding claim 125, B2014, Schwager, and B2016 teach the pressure guidewire of claim 24, wherein the sensor housing [B2014 Fig. 2 Item 106] is in contact with the connector tube [B2014 Fig. 19 Item 252] and the coil portion [B2014 Fig. 3 Items 132, 134, and 136] is in contact with the sensor housing, each of the connector tube [B2014 0085 “…the conductive element 270 is advanced distally along the tubular member 252…”], the sensor housing [B2014 0056”…the flexible elongate member 106 comprises a stainless steel hypotube…”], and the coil portion [B2014 0063 “…the conductive portions 132, 134, and 136”] comprising a conductive material.
Claims 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over B2014, Schwager, and B2016 as applied to claim 1 above, and further in view of Tenerz (US 6106486 A).
Regarding claim 24, B2014, Schwager, and B2016 teach the pressure guidewire of claim 16, but fail to teach wherein the sensor housing has at least one opening.
Tenerz teaches wherein the sensor housing has at least one opening [Fig 3, examiner is using Fig. 2 Item 41 to reference Fig. 3’s opening].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the teachings of B2014, Schwager, and B2016 with the teachings of Tenerz to include the outer tube further comprises a sensor housing having at least one opening. Doing so configures the system to expose the sensor to the environment to provide an accessible means of interfacing with the sensor.
Regarding claim 25, B2014, Schwager, B2016, and Tenerz teach the pressure guidewire of claim 24, wherein the at least one opening allows fluid to flow [This is interpreted as intended use of an apparatus. The opening in the device disclosed by Tenerz would allow fluid to flow inside.] in a space between the connector tube [Tenerz Fig. 3 Item 40] and the core wire [Tenerz Fig. 3 Item 54].
Regarding claim 26, B2014, Schwager, B2016, and Tenerz teach the pressure guidewire of claim 24, wherein the pressure sensor [B2014 Fig. 2 Item 112] is positioned within the sensor housing [B2014 Fig. 2 Item 106, 0056 “…component 112 is positioned within the distal portion 107 of the flexible elongate member 106…”].
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over B2014, Schwager, and B2016 as applied to claim 16 above, and further in view of Hui (US 20140257138 A1).
Regarding claim 30, B2014, Schwager, and B2016 teach the pressure guidewire of claim 16, wherein the distal tip [Schwager Fig. 2 Item 51] is adhered to a distal section of the core wire [Schwager Fig. 2 Item 54, col. 5 lns. 55-57], but fail to teach it is adhered with an adhesive.
Hui teaches the distal tip [Fig. 2 Item 40] is adhered to a distal section of the core wire [Fig. 2 Item 20] with an adhesive [0015 “The interconnection of the core 20, anchor wire 30, and tip 40 is achieved by known means, such as adhesives or soldering”].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to take the teachings of B2014, Schwager, and B2016 and incorporate the teachings of Hui to include distal tip is adhered to a distal section of the core wire with an adhesive. Doing so bonds the tip to the body of the device by a “known means” by a more cost-effective method than soldering.
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 JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791