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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-13, and 15-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20200289085 A1 by Stigall et al. (hereafter Stigall).
Regarding claim 1, Stigall teaches: 1. A medical device configured and sized to be positioned within a subject (see Stigall’s Abstract), comprising:
an ultrasound transducer disposed in a distal region of the medical device, the ultrasound transducer at least partially enclosed by a material to define a distal tip of the medical device (see Stigall’s Fig. 3-5 part 110, wherein Figs. 3-4 show the scanner assembly on its own and integrated into the tip respectively and wherein Figs. 5 show the whole of the distal tip including the tip extension 304 attached to/adjacent to the scanner assembly 110, see also e.g. [0034] for the scanner assembly being ultrasonic/including a transducer); and
a tip extension disposed adjacent the distal tip and extending longitudinally from the distal tip, the tip extension comprising a first end adjacent the distal tip and a second end opposite the first end (see Stigall’s Figs. 5 noting tip extension 304 with its position being such that it extends from and is distal to the other elements being clearly depicted),
wherein the tip extension comprises a tapered tip at or adjacent the second end, wherein the tip extension comprises a guidewire lumen formed therein and configured to receive a guidewire therethrough (regarding the taper, see Stigall’s Figs. 5 or see [0055]. Regarding the guidewire lumen see these same sections or see Stigall’s Figs. 3-4 noting guidewire lumen 236 see [0049]), and
wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness (Stigall teaches this in two separate ways, first, one can simply see from the depiction that the tip extension’s thickness reduces as it proceeds distally/towards the second end as shown in Figs. 5 and in myriad other Figs. with the clearest examples shown in Figs. 6-7 and 12-13. Secondly, the material choice can also be changed to allow the flexibility to decrease as one proceeds distally/approaches the second end as per e.g. [0061]).
Regarding claims 3 and 5 together, Stigall teaches: 3. The medical device of claim 1, wherein the guidewire lumen comprises one or more lumen aperture configured to allow entrance and removal of a guidewire from the guidewire lumen. And 5. The medical device of claim 1, wherein the guidewire lumen extends along at least a part of a length of the ultrasound transducer (see Stigall’s Figs. 3 and 5C and note the tip member’s lumen 314 has at least one aperture, e.g. at the tip 332, and proceeds through the transducer at 236 and/or simply see [0049] which textually describes this. Such an arrangement being fully capable of allowing the entrance or removal (i.e. extension or retraction) of a guidewire therethrough).
Regarding claim 4, Stigall teaches: 4. The medical device of claim 1, wherein the guidewire lumen comprises a first lumen aperture disposed along a length of the tip extension and a second lumen aperture disposed at the tapered tip, wherein the first lumen aperture and the second lumen aperture are configured to allow entrance and removal of a guidewire from the guidewire lumen (Stigall has a second aperture as depicted in all of Figs. 5-14, with Fig. 12 having lumen 314 end in aperture 346 being exemplary; however, Stigall never depicts the first aperture as all depiction of his invention use an over the wire design. However, Stigall textually describes a first aperture at the distal end as part of a rapid exchange design at [0039] so as to teach this subject matter).
Regarding claim 6, Stigall teaches: 6. The medical device of claim 1, wherein the ultrasound transducer comprises an emitter face and the guidewire lumen extends along at least a part of a length of the ultrasound transducer opposite the emitter face (see Stigall’s Fig. 4 where the flex circuit 214 with its transmitter face looks outward to view the tissue and where the lumen 236 is opposite thereof).
Regarding claims 7-8 together, Stigall teaches 7. The medical device of claim 1, wherein the tip extension is coupled to the distal tip. And 8. The medical device of claim 1, wherein the tip extension is fused to the distal tip (regarding both of these together, Stigall has multiple ways of bonding the tip extension 304 to the distal tip of the device each of which would appear to read on both claimed options, see e.g. [0057] noting that among other options this is mechanically connected and also can be bonded via adhesive which would cover coupling and fusing respectively).
Regarding claim 9, Stigall teaches: 9. The medical device of claim 1, further comprising an outer shaft coupled to a proximal end of the distal tip (see Stigall’s Fig. 4 noting outer member 254 coupled to the proximal end of the distal tip or see Stigall’s Fig. 6B noting that support 230 is coupled to that and is even more proximal which leads to 256 as depicted in Fig. 5B which is even more proximal etc., each of which are an outermost shaft at some point as one proceeds more proximal).
Regarding claim 10, Stigall teaches: 10. The medical device of claim 9, wherein the guidewire lumen extends along at least a part of a length of the outer shaft (when using over the wire, see Stigall’s Fig. 4 noting lumen 236 proceeding along 254 towards the proximal end and thus along this and the other nearby outer shaft options so this is taught explicitly. Likewise see [0039] and note that even when using a rapid exchange design the guidewire must still extend along (i.e. in the same proximal direction and in the vicinity of) the outer shaft so as to be taught implicitly).
Regarding claim 11, Stigall teaches: 11. A medical device configured and sized to be positioned within a subject (see Stigall’s Abstract), comprising:
an ultrasound transducer disposed in a distal region of the medical device, the ultrasound transducer at least partially enclosed by a material to define a distal tip of the medical device (see Stigall’s Fig. 3-5 part 110, wherein Figs. 3-4 show the scanner assembly on its own and integrated into the tip respectively and wherein Figs. 5 show the whole of the distal tip including the tip extension 304 attached to/adjacent to the scanner assembly 110, see also e.g. [0034] for the scanner assembly being ultrasonic/including a transducer); and
a tip extension disposed adjacent the distal tip and extending longitudinally from the distal tip, the tip extension comprising a first end adjacent the distal tip and a second end opposite the first end (see Stigall’s Figs. 5 noting tip extension 304 with its position being such that it extends from and is distal to the other elements being clearly depicted),
wherein the tip extension comprises a guidewire lumen formed therein and configured to receive a guidewire therethrough (regarding the taper, see Stigall’s Figs. 5 or see [0055]. Regarding the guidewire lumen see these same sections or see Stigall’s Figs. 3-4 noting guidewire lumen 236 see [0049]), and
wherein the tip extension exhibits a transition in stiffness along a length thereof (Stigall teaches this in two separate ways, first, one can simply see from the depiction that the tip extension’s thickness reduces as it proceeds distally/towards the second end as shown in Figs. 5 and in myriad other Figs. with the clearest examples shown in Figs. 6-7 and 12-13. Secondly, the material choice can also be changed to allow the flexibility to decrease as one proceeds distally/approaches the second end as per e.g. [0061], third and given the increased breadth versus the other sub-combination Stigall can also add reinforcement members such as is shown in Fig. 14 at part 334).
Regarding claim 12, Stigall teaches: 12. The medical device of claim 11, wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness (Stigall teaches this in two separate ways, first, one can simply see from the depiction that the tip extension’s thickness reduces as it proceeds distally/towards the second end as shown in Figs. 5 and in myriad other Figs. with the clearest examples shown in Figs. 6-7 and 12-13. Secondly, the material choice can also be changed to allow the flexibility to decrease as one proceeds distally/approaches the second end as per e.g. [0061]).
Regarding claim 13, Stigall teaches: 13. The medical device of claim 11, wherein the tip extension comprises a tapered tip at or adjacent the second end (regarding the taper, see Stigall’s Figs. 5 or see [0055]).
Regarding claims 15 and 17 together, Stigall teaches: 15. The medical device of claim 11, wherein the guidewire lumen comprises one or more lumen aperture configured to allow entrance and removal of a guidewire from the guidewire lumen. And 17. The medical device of claim 11, wherein the guidewire lumen extends along at least a part of the length of the ultrasound transducer (see Stigall’s Figs. 3 and 5C and note the tip member’s lumen 314 has at least one aperture, e.g. at the tip 332, and proceeds through the transducer at 236 and/or simply see [0049] which textually describes this. Such an arrangement being fully capable of allowing the entrance or removal (i.e. extension or retraction) of a guidewire therethrough).
Regarding claim 16, Stigall teaches: 16. The medical device of claim 11, wherein the guidewire lumen comprises a first lumen aperture disposed along a length of the tip extension and a second lumen aperture disposed adjacent an end of the tip extension, wherein the first lumen aperture and the second lumen aperture are configured to allow entrance and removal of a guidewire from the guidewire lumen (Stigall has a second aperture as depicted in all of Figs. 5-14, with Fig. 12 having lumen 314 end in aperture 346 being exemplary; however, Stigall never depicts the first aperture as all depiction of his invention use an over the wire design. However, Stigall textually describes a first aperture at the distal end as part of a rapid exchange design at [0039] so as to teach this subject matter).
Regarding claim 18, Stigall teaches: 18. The medical device of claim 11, wherein the ultrasound transducer comprises an emitter face and the guidewire lumen extends along at least a part of the length of the ultrasound transducer opposite the emitter face (see Stigall’s Fig. 4 where the flex circuit 214 with its transmitter face looks outward to view the tissue and where the lumen 236 is opposite thereof).
Regarding claims 19-20 together, Stigall teaches: 19. The medical device of claim 11, wherein the tip extension is coupled to the distal tip. 20. The medical device of claim 11, wherein the tip extension is fused to the distal tip (regarding both of these together, Stigall has multiple ways of bonding the tip extension 304 to the distal tip of the device each of which would appear to read on both claimed options, see e.g. [0057] noting that among other options this is mechanically connected and also can be bonded via adhesive which would cover coupling and fusing respectively).
Regarding claim 21, Stigall teaches: 21. The medical device of claim 11, further comprising an outer shaft coupled to a proximal end of the distal tip (see Stigall’s Fig. 4 noting outer member 254 coupled to the proximal end of the distal tip or see Stigall’s Fig. 6B noting that support 230 is coupled to that and is even more proximal which leads to 256 as depicted in Fig. 5B which is even more proximal etc., each of which are an outermost shaft at some point as one proceeds more proximal).
Regarding claim 22, Stigall teaches: 22. The medical device of claim 21, wherein the guidewire lumen extends along at least a part of the length of the outer shaft (when using over the wire, see Stigall’s Fig. 4 noting lumen 236 proceeding along 254 towards the proximal end and thus along this and the other nearby outer shaft options so this is taught explicitly. Likewise see [0039] and note that even when using a rapid exchange design the guidewire must still extend along (i.e. in the same proximal direction and in the vicinity of) the outer shaft so as to be taught implicitly).
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.
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.
Claim(s) 2 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall as applied to claims 1 and 11 above, and further in view of US 20150305710 A1 by Stigall et al. (hereafter Stigall2).
Regarding claims 2 and 14, Stigall teaches the basic invention as given above in regards to claims 1 and 11 and Stigall further teaches: 2/14. The medical device of claim 1/11, further comprising an ultrasound probe comprising the ultrasound transducer and a flexible circuit strip in electrical communication with the ultrasound transducer, the flexible circuit strip further comprising an insulating substrate, a plurality of conductive traces disposed on and extending along the insulating substrate (each of the foregoing can be seen and described succinctly in Stigall’s Fig. 2 and [0040] which show the transducers 212 and traces 216 on substrate of the flex circuit 214, with [0044]-[0048] providing additional information about specifics of how this flex circuit is constructed), …
Stigall does not mention using an insulation member that covers over the conductive traces and thus fails to fully teach the limitation: “a portion of one or more of the plurality of conductive traces covered by an insulation member.”
However Stigall2 in the exact same or eminently related field of intravascular ultrasound devices (see Stigall2’s Abstract) teaches that when constructing the exact same sort of transducer array using a flexible circuit wrapped on a support that it is advantageous to include an outer member to insulate and cover the flex circuit as this protects the scanner from the environment (see Stigall2’s [0036] which describes this as well as the advantage. In short, the scanner 110 is wrapped in an insulator part 504 which protects it from the environment, see also e.g. Figs. 5-6 part 504).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to improve the invention of Stigall with the use of an insulating layer as taught by Stigall2 in order to advantageously protect the ultrasound electronics from the environment.
Claim(s) 23-34 are rejected under 35 U.S.C. 103 as being unpatentable over US 20180279994 A1 by Schaer et al. (hereafter Schaer) further in view of Stigall.
Regarding claim 23, Schaer teaches: 23. A medical device configured and sized to be positioned within a subject (see Schaer’s Abstract), comprising:
an ultrasound probe disposed adjacent a distal region of a rotatable shaft, the ultrasound probe comprising an ultrasound transducer (regarding the ultrasound probe, see Fig. 1 noting part 1010 or Fig. 36 noting part 3000, where in both instances the medical tool can be/comprise an ultrasound transducer per se as per [0099] and [0198] respectively. Regarding the rotatable shaft, see upon which the probe is mounted, see [0096] and [0198]-[0199] which describe that the tool is mounted on a shaft that is rotatable);
a deflectable shaft disposed relative to the rotatable shaft such that deflection of the deflectable shaft causes deflection of at least a portion of the rotatable shaft (see Figs. 1 noting part 1008 or Figs. 36 noting part 1208, with the deflection depicted in Figs. 1 as dashed lines and described in [0096] or as described in [0198]-[0199] as addressed below for Fig. 36, with the description clarifying that the rotatable shaft is within);
a handle assembly comprising a handle body with an outer surface that can be gripped by a user, a first actuator configured to be moved relative to the handle body, and a second actuator configured to be moved relative to the handle body, wherein the first actuator and the second actuator are circumferentially disposed about a longitudinal axis of the handle body, wherein the rotatable shaft is in operable communication with the first actuator of the handle assembly such that actuation of the first actuator causes rotational movement of at least a portion of the rotatable shaft relative to the deflectable shaft, and wherein the deflectable shaft is in operable communication with the second actuator such that rotation of the second actuator causes deflection of the deflectable shaft and thereby deflection of the rotatable shaft (regarding each of these together, simply see Figs. 1 which shows handle 1002 with first actuator 1001 and second actuator 1003 disposed circumferentially around the longitudinal axis and where, as per [0096], these can deflect and rotate the shafts respectively or see Figs. 36 which show a handle 1206 with a first actuator 1230 and second actuator 1220 disposed circumferentially around the longitudinal axis and where, as per [0198]-[0199], these can rotate the medical device with ultrasound imaging tip 3000 and can steer the deflectable shaft 1208 respectively);
Schaer also generally teaches that the medical tool can be guided by a guidewire (mentioned in [0108] in the context of other tool options) which is notable as Schaer’s medical tool is intended to be able to proceed past the end of the positioning device (notably depicted in both Figs. 1 and 36, with e.g. 1010 extending past the end of 1008, but also descried in many pklaces such as [0135] where a 3 cm to 20 cm extension beyond the steering portion is described) but Schaer never iterates any information about a tip extension nor any information about how any guidewire or guidewire lumen interacts with the tip extension or ultrasound assembly. Therefore, Schaer fails to teach: “and a tip extension disposed adjacent a distal end of the ultrasound probe and extending longitudinally from the ultrasound probe, the tip extension comprising a first end adjacent the ultrasound probe and a second end opposite the first end, wherein the tip extension comprises a guidewire lumen formed therein and configured to receive a guidewire therethrough, and wherein the tip extension exhibits a transition in stiffness along a length thereof.”
However Stigall in the same or eminently related field of intravascular ultrasound imaging (see Stigall’s Abstract) teaches a tip extension and guidewire lumen that can be used in proximity to an ultrasound imaging device including each of:
a tip extension disposed adjacent a distal end of the ultrasound probe and extending longitudinally from the ultrasound probe, the tip extension comprising a first end adjacent the ultrasound probe and a second end opposite the first end (see Stigall’s Figs. 5 noting tip extension 304 with its position being such that it extends from and is distal to the other elements being clearly depicted),
wherein the tip extension comprises a guidewire lumen formed therein and configured to receive a guidewire therethrough (regarding the taper, see Stigall’s Figs. 5 or see [0055]. Regarding the guidewire lumen see these same sections or see Stigall’s Figs. 3-4 noting guidewire lumen 236 see [0049]), and
wherein the tip extension exhibits a transition in stiffness along a length thereof (Stigall teaches this in two separate ways, first, one can simply see from the depiction that the tip extension’s thickness reduces as it proceeds distally/towards the second end as shown in Figs. 5 and in myriad other Figs. with the clearest examples shown in Figs. 6-7 and 12-13. Secondly, the material choice can also be changed to allow the flexibility to decrease as one proceeds distally/approaches the second end as per e.g. [0061], third and given the increased breadth versus the other sub-combination Stigall can also add reinforcement members such as is shown in Fig. 14 at part 334).
Stigall goes on to teach that this sort of arrangement is advantageous (specifically Stigall teaches in general that such a tip having a flexible geometry and guide wire lumen allows the tip to facilitate getting the IVUS device to the area of interest in [0006] and [0039]. Stigall goes on to more explicitly address that the combination of such a tip and a guidewire allows for traversing many different types of vasculature and for allowing imaging in many different situations such as when needing to cross occlusions, avoid stents, traverse tight bends, etc. with specific details and explicit statements of advantage for various tip geometries discussed in Stigall’s [0064]-[0065]).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to incorporate Stigall’s tip extension and guidewire lumen into Schaer’s medical tool in order to advantageously allow for safely and effectively guiding the medical tool through the vasculature even when it is extended past the end of the deflectable shaft.
Regarding claim 24, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 24. The medical device of claim 23, wherein the tip extension exhibits a first stiffness at the first end and a second stiffness adjacent the second end, wherein the first stiffness is greater than the second stiffness (Stigall teaches this in two separate ways, first, one can simply see from the depiction that the tip extension’s thickness reduces as it proceeds distally/towards the second end as shown in Figs. 5 and in myriad other Figs. with the clearest examples shown in Figs. 6-7 and 12-13. Secondly, the material choice can also be changed to allow the flexibility to decrease as one proceeds distally/approaches the second end as per e.g. [0061]).
Regarding claim 25, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 25. The medical device of claim 23, wherein the tip extension comprises a tapered tip at or adjacent the second end (regarding the taper, see Stigall’s Figs. 5 or see [0055]).
Regarding claim 26, Schaer IVO Stigall teaches the basic invention as given above and Schaer further teaches: 26. The medical device of claim 23, wherein the ultrasound probe comprises a flexible circuit strip in electrical communication with the ultrasound transducer, the flexible circuit strip further comprising an insulating substrate, a plurality of conductive traces disposed on and extending along the insulating substrate, a portion of one or more of the plurality of conductive traces covered by an insulation member (Schaer’s [0010] teaches this with full coverage of the insulating layer, [0018] teaches this with partial cover of the insulating layer).
Regarding claims 27 and 29 together, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 27. The medical device of claim 23, wherein the guidewire lumen comprises one or more lumen aperture configured to allow entrance and removal of a guidewire from the guidewire lumen. And 29. The medical device of claim 23, wherein the guidewire lumen extends along at least a part of the length of the ultrasound transducer (see Stigall’s Figs. 3 and 5C and note the tip member’s lumen 314 has at least one aperture, e.g. at the tip 332, and proceeds through the transducer at 236 and/or simply see [0049] which textually describes this. Such an arrangement being fully capable of allowing the entrance or removal (i.e. extension or retraction) of a guidewire therethrough).
Regarding claim 28, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 28. The medical device of claim 23, wherein the guidewire lumen comprises a first lumen aperture disposed along a length of the tip extension and a second lumen aperture disposed adjacent an end of the tip extension, wherein the first lumen aperture and the second lumen aperture are configured to allow entrance and removal of a guidewire from the guidewire lumen (Stigall has a second aperture as depicted in all of Figs. 5-14, with Fig. 12 having lumen 314 end in aperture 346 being exemplary; however, Stigall never depicts the first aperture as all depiction of his invention use an over the wire design. However, Stigall textually describes a first aperture at the distal end as part of a rapid exchange design at [0039] so as to teach this subject matter).
Regarding claim 30, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 30. The medical device of claim 23, wherein the ultrasound transducer comprises an emitter face and the guidewire lumen extends along at least a part of the length of the ultrasound transducer opposite the emitter face (see Stigall’s Fig. 4 where the flex circuit 214 with its transmitter face looks outward to view the tissue and where the lumen 236 is opposite thereof).
Regarding claims 31-32 together, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 31. The medical device of claim 23, wherein the tip extension is coupled to the ultrasound probe. And 32. The medical device of claim 23, wherein the tip extension is fused to the ultrasound probe (regarding both of these together, Stigall has multiple ways of bonding the tip extension 304 to the distal tip of the device each of which would appear to read on both claimed options, see e.g. [0057] noting that among other options this is mechanically connected and also can be bonded via adhesive which would cover coupling and fusing respectively).
Regarding claim 33, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 33. The medical device of claim 23, further comprising an outer shaft coupled to a proximal end of the ultrasound probe (see Stigall’s Fig. 4 noting outer member 254 coupled to the proximal end of the distal tip or see Stigall’s Fig. 6B noting that support 230 is coupled to that and is even more proximal which leads to 256 as depicted in Fig. 5B which is even more proximal etc., each of which are an outermost shaft at some point as one proceeds more proximal).
Regarding claim 34, Schaer IVO Stigall teaches the basic invention as given above and Stigall further teaches: 34. The medical device of claim 33, wherein the guidewire lumen extends along at least a part of the length of the outer shaft (when using over the wire, see Stigall’s Fig. 4 noting lumen 236 proceeding along 254 towards the proximal end and thus along this and the other nearby outer shaft options so this is taught explicitly. Likewise see [0039] and note that even when using a rapid exchange design the guidewire must still extend along (i.e. in the same proximal direction and in the vicinity of) the outer shaft so as to be taught implicitly).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is as follows:
US 20190053782 A1 by Stigall et al. (hereafter Stigall3) teaches a similar invention to Stigall including the use of a tapered tip and guidewire lumen proceeding centrally therethrough, but Stigall3 does so with a unidirectional transducer on a rotating shaft. As such it is clearly a relevant reference. Given that Schaer already provided the rotating shaft and transducer, Stigall is seemingly a better reference in combination to Schaer for claim 23 at this juncture, but Stigall3 would seemingly allow the examiner to entirely replace instead of modify the medical tool of Schaer which may become a better rejection dependent on future amendments.
US 20190053783 A1 by Stigall et al. (hereafter Stigall4) teaches a similar invention to Stigall but actually shows instead of merely describes how one would employ RX instead of OTW guides, see e.g. Fig. 1, and thus may be relevant to understanding how one of ordinary skill in the art would understand an RX guide is structured and employed in such an invention.
US 20190247017 A1 by Minas et al. (hereafter Minas) teaches a similar invention to Stigall but actually shows instead of merely describes how one would employ RX instead of OTW guides, see e.g. Fig. 4, and thus may be relevant to understanding how one of ordinary skill in the art would understand an RX guide is structured and employed in such an invention.
US 20200000524 A1 by Stigall et al. (hereafter Stigall5) teaches a somewhat less related but still relevant device. In this instance the examiner notes that Stigall5 shows both or either of OTW and RX guides can be used and can even be used at the same time and thus may be relevant to understanding how one of ordinary skill in the art would understand an RX guide is structured and employed in such an invention or in allowing the examiner to reject features of both RX and OTW designs in the same claim.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798