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 & 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 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.
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) 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) alone, or in the alternative, under 35 U.S.C. 103 as obvious over Stigall further in view of US 20180279994 A1 by Schaer et al. (hereafter Schaer).
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]),
and further comprising an irrigation lumen routed through at least a portion of the length of the medical device, the irrigation lumen joining the guidewire lumen to facilitate flushing of the guidewire lumen (noting that the claim does not ever give any further structure (i.e. the only structure at issue is a lumen – something which already exists in the claim, there is no fluid reservoir, no pumps, no ports, no valves, etc. – this limitation only applies a name for/intended use of a portion of the lumen) and expressly states that the lumens are the same/conjoined for at least a portion of their length (i.e. the irrigation lumen joining the guidewire lumen to facilitate flushing of the guidewire lumen) and does not ever expressly state that any portion of the irrigation lumen ever need be separate from the guidewire lumen, as such see Stiggall’s Figs. 3-5 or [0049] and [0055] noting at least lumen 236 as described therein where the lumen could have a fluid be flushed through it and thus is fully capable of the claimed function and joins with/is the guidewire lumen).
Additionally or alternatively, one potential reading, though never expressly claimed and not the only viable reading under the broadest reasonable interpretation – see 102 rejection above, of the phrase “joining” is that the lumens are separate for some span. To that end and for compact prosecution purposes the examiner additionally or alternatively notes that Schaer in the same or eminently related field of the structure of elongated intravascular devices that can accommodate US imaging (see Schaer’s Abstract and [0196]) teaches an initially separate but later conjoined irrigation lumen having a hemostatic valve junction to connect the lumens just as is done in the applicant’s specification and which has luer lock connectors to allow the connection of fluid supply lines and which is even expressly intended to be used for irrigation per se despite the intended use of the lumen having no clear ramifications for its actual structure (see any of Schaer’s e.g. Figs. 8-13 with Fig. 11A being exemplary as it shows a blown-up and exploded view with the hemostatic valve 1950 joining a lumen that proceeds out and away from the handle to the lumen of sheath 1208, where the former is used for introduction of irrigation fluids into the later by its very position and arrangement, see also Schaer’s [0153] which states in salient part “FIG. 8 also illustrates a hemostasis valve assembly 1950 within the handle portion 1206 which is useful to keep blood or other fluids from leaking out from the proximal end of steerable sheath 1202, and to allow flushing of the luminal space between tool 1204 and the inner lumen of sheath 1202.” Which expressly details that this valve is intended to join irrigation lumen to the tool lumen (i.e. guidewire lumen in the vernacular primary reference) to allow flushing (i.e. irrigation) of fluid out of that lumen). Schaer goes on to teach that this is irrigation arrangement is advantageous (see Schaer’s [0153], [0173], and/or [0220] which describes that being able to flush clean fluid through the lumen prevents contamination of the lumen by bodily fluids and that contamination with body fluids presents an issue for cleaning and reuse of the structures, so as to establish that it is advantageous to flush the lumen and prevent such contamination/to reduce the need for and complexity of sterilization before reuse).
Therefore and in the alternative, 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 an irrigation lumen connected to the guidewire lumen to allow flushing of the guidewire lumen which would advantageously prevent fluid from leaking out the proximal end/spreading contamination and also minimize contamination and sterilization requirements for the medical device.
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 a navigation sensor is disposed in a portion of the tip extension and configured to facilitate display of the tip extension in a mapping or navigation system (noting that the sensor has no defined structure and is instead only defined by its function of being “to facilitate display of the tip extension” the only requirement is that portion of the tip extension that qualifies as the navigation sensor is imageable in some modality – as the mapping or navigation system are neither structurally included in the claim nor specially defined in the specification and the only limitation on them is that they are able to result in a display of some form. To that end, all physically existing material is imageable in some modality and thus this limitation is inherent. For example, plastics and ceramics are imageable in US, and metals are extremely imageable in both US and x-ray such that any structure in the tip extension, e.g. reinforcement member 334 shown in Stigall’s Fig. 14, can be considerable as a navigation sensor as it will show up in (i.e. facilitate) display of the tip in such imaging modalities. Alternatively, Stigall teaches that the invention can be used with fluoroscopic imaging in [0037] among other options which would be a navigation system and thus would likewise teach the claimed limitation in its broad form as it would require that the invention be imageable by such a navigation system. Additionally, the examiner notes that it still may compact prosecution to add in one of the two disclosed navigation sensors of the applicant’s specification and therefore this limitation is also/alternatively rejected under 103 below for compact prosecution purposes),
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).
In the foregoing the examiner noted that while no specific structure of the sensor is required by the claim language, that it may compact prosecution to include and additional/alternative grounds of rejection which addressed the structure of the sensors as used by the applicant’s examples in the specification, specifically either “a polymer compounded with a radiopaque material” or “radiopaque marker bands/braids/coils comprising platinum and other materials” as described in [00143] of the applicant’s specification which is the only section of the specification to mention as sensor that is incorporated in the tip extension. To that end, the examiner notes that Schaer in the same or related field of the structure of elongated intravascular devices that can accommodate US imaging (see Schaer’s Abstract and [0196]) teaches both of these examples (see e.g. [1026] noting at least “The thermoplastic polymer may also have radiopaque compounds that include materials such as bismuth, barium sulfate, or tungsten in order that the tip of the sheath be visible to the user under fluoroscopy.” Or alternatively see [0198] noting at least “The keys 3010/3011 or 3020/3021 are preferably formed from a rigid machined or molded plastic (e.g., polycarbonate, peek, epoxy, etc., known in the art), or metal (e.g., stainless steel, platinum, iridium, tungsten, etc.), rare earth magnets (e.g., neodymium, samarium-cobalt, etc.), or any combination thereof. To allow for fluoroscopic visualization, the material may be inherently radiopaque or contain radiopaque fillers such as barium sulfate, tantalum, tungsten, etc.” which teach both of the applicant’s specified options and even use the exact same option of platinum). Likewise this is both inherently advantageous and also has a stated advantage in Schaer (e.g. “to allow for fluoroscopic visualization” in the citations above, and inherently this serves to allow guiding of the device to the proper location within the body, and also this directly results in the applicant’s intended use of “facilitate display … in a navigation system” as per e.g. [0199] which states that the user can see the fluoroscopic display on a screen, each clarifying that this is advantageous for guidance and location monitoring purposes).
Therefore and in the alternative, it would have been obvious to one of ordinary skill in the art prior to the date of invention to include a sensor visible in fluoroscopic imaging of the sort taught by Schaer as it would advantageously allow for visualization and guidance of the medical device.
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 alternatively IVO Schaer 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 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 places 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).
Response to Arguments
Applicant's arguments filed 05/22/2026 have been fully considered but they are not persuasive, with each argument being responded to in the order presented as follows:
On page 10 the applicant opines that the newly added claim language of claims 1 and 11 is not taught by Stigall. In this instance the examiner notes that the wording was so broad that it was covered by Stigall’s guidewire lumen for claim 1 and by inherency for claim 11. As such the argument is rebutted by noting the newly added citations and discussion of the material of Stigall which is provided in the rejection above and incorporated herein by reference. Additionally, the examiner understands what the applicant is attempting to claim and has additionally included alternative rejections along the lines of the applicant’s specification in each instance because the examiner is required to provide the best grounds of rejection and it appears that while the applicant has not technically overcome the rejection of Stigall alone that Stigall alone is likely not the best grounds of rejection in both instances as the embodiments of the applicant’s specification are expressly taught by Schaer in both instances.
On pages 10-11 the applicant argues that the combination of Schaer and Stigall does not teach the claimed limitations. In this instance the applicant’s characterization of the rejection significantly differs from the examiner’s provided rejection (e.g. the examiner does not require Stigall to teach a guidewire lumen as the applicant claims – Schaer already has a lumen larger than is required to accommodate a guidewire and also teaches that the tools he uses therein can have guidewire lumens themselves, rather the examiner uses Stigall to teach the tip extension as the only additional structure and then further uses Stigall to teach how the guidewire would interact with (e.g. proceed through as is done in Stigall’s invention and in the embodiment shown in Schaer’s Fig. 6 for a non-US tool) the US imaging device because Schaer teaches that the tools can have guidewire lumens but is silent as to whether the US imaging tool specifically has or does not have a guidewire lumen of the sort claimed). Rather when one looks at what is actually presented the examiner has chosen two very similar arrangements, both being an elongated medical device intended for use with US imaging both having a central lumen designed to accommodate a tool, and they differ insofar as Schaer does not teach the tip extension and insofar as Stigall’s tool is a guidewire and Schaer’s tool is a larger device for US imaging. See the actual text of the rejection which establishes what Schaer does and does not teach and what the examiner is using Stigall to provide, e.g. cited verbatim from the foregoing:
“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 places 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.”
-And-
“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:”
As such the argument has fundamental flaws that cause it to be unconvincing as it addresses a straw-man facsimile of the examiner’s rejection and not the rejection itself which is more narrowly drawn.
Additionally or alternative, the examiner can also rebut this by noting that the argument proceeds from there to opine that despite the examiner referencing where in Stigall it is provided that the tip extension can allow the tool to be “safely and effectively” guided through the vasculature the applicant opines that this is a “desired result” and not an advantage. The examiner notes that the inclusion of the tip, which is atraumatic and flexible enough to bend with the vessel and also has enough structure/stiffening elements to allow it to traverse bends and retain the guidewire is in fact an explicit advantage over an elongated member without such a tip. The applicant appears to entirely ignore all portions of the examiner’s provided rational, and indeed even ignore the actual wording they are citing as “allow the tool to be “safely and effectively” guided through the vasculature” is rather expressly an advantage and instead appears to merely argue without addressing the text of the rejection or any merit thereof. For compact prosecution purposes the examiner reminds the applicant that this advantage of Stigall was expressly referenced and the verbatim citation thereof is reproduced below to clarify exactly that this argument is without merit when one actually brings in the text of the provided rejection, see:
“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]).”
Which in summary describes and documents how and why one of ordinary skill would understand that a flexible tip extension that can accommodate a guidewire in fact increases the ability of the device to be safely and effectively guided within the vasculature and thus is advantageous. Therefore and for the foregoing reasons the examiner was not convinced, for at least those two reasons, that there is any issue with the rejection provided and therefore has not been convinced to remove or modify the 103 rejection featuring Schaer IVO Stigall.
Lasty the applicant concludes by asserting that the dependent claims are patentable at least by virtue of dependency from an allowable claims. The examiner is not convinced by this argument at the current juncture given the above identified issues with and rebuttal to the applicant’s arguments as addressed above.
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 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 RAYMOND/Supervisory Patent Examiner, Art Unit 3798
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