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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/19/2026 has been entered.
Response to Arguments
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Claim Rejections - 35 USC § 103
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.
Claims 1, 6, 8, 10, 24, and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Waters (US 20130137980) and further in view of Corl (US 20140180128), Hamm (US 5368035), and Havel (US 20170042508).
Regarding claim 1, Waters discloses an imaging catheter (title – “Catheters for imaging”) comprising:
an imaging assembly provided at a distal portion of the catheter (Fig. 1 ultrasound transducer 190 and transducer housing 130),
a transducer unit comprising one or more acoustic transducers […] within the […housing] and aligned with the imaging window […] (Fig. 1 shows ultrasound transducer 190 within transducer housing 130, [0029] – “Ultrasound transducer 190 can include at least a piezoelectric layer”, [0026] – “restrict the longitudinal position of transducer housing 130 and ultrasound transducer 190 with respect to imaging window 12”); and a pair of bearings coupled to the shell, including a first bearing positioned at a more proximal end of the imaging assembly (Fig. 1 proximal bearing 120) and a second bearing positioned at a more distal end of the imaging assembly (Fig. 1 distal bearing 122), the pair of bearings assisting in movement of at least the transducer unit and enabling smooth rotation thereof ([0027] – “Transducer housing 130 can include proximal journal 131 and distal journal 132. Proximal journal 131 rotates within proximal bearing 120. Distal journal 132 rotates within distal bearing 122”, [0028] – “Non-uniform rotation of imaging core 100 may be minimized by aligning proximal bearing 120 and distal bearing 122 near the rotational center of imaging core 100 and fixing each bearing to the catheter”);
a torque shaft operably associated with the imaging assembly ([0027] – “Proximal journal 131 can be bonded to torque coil 102 to enable rotation of transducer housing 130 when torque coil 102 rotates”), the torque shaft comprising a flexible tube ([0005] – “Minimally invasive intracardiac RF ablation catheters for ablation of cardiac structures may be used to treat cardiac arrhythmias”, the torque shaft would be flexible to be translated through the body to the cardiac structures) for transmitting torque forces upon the transducer unit and configured to cause full rotation of the transducer unit upon operation thereof ([0027] – “Proximal journal 131 can be bonded to torque coil 102 to enable rotation of transducer housing 130 when torque coil 102 rotates”, the baseline image and current image in Fig. 7 appear to show an image completely surrounding the catheter 402 therefore it can be interpreted there is full rotation of the torque coil), the imaging assembly being operably associated with the torque shaft via direct engagement between […] a distal end of the torque shaft and […] a proximal end of the […housing] ([0027] – “Transducer housing 130 can include proximal journal 131…Proximal journal 131 can be bonded to torque coil 102 to enable rotation of transducer housing 130 when torque coil 102 rotates”, as seen in Fig. 1 the proximal journal 131 is bonded to the distal end of the torque coil);
an outer sleeve positioned over the imaging assembly that encloses the imaging assembly in a manner that a gap is defined between the imaging assembly and an interior surface of the outer sleeve (Fig. 1 shows outer sleeve [midshaft 10 and imaging window 10] positioned over the imaging assembly and enclosing the imaging assembly with a gap defined between the imaging assembly and an interior surface of the outer sleeve, [0027] – “transducer housing 130 may be enclosed by midshaft 10 and imaging window 12”);
a volume of fluid provided within the gap between the imaging assembly and the interior surface of the outer sleeve, the volume of fluid comprising an acoustic coupling fluid ([0032] – “Imaging core lumen 11 can be preferably filled with a flushing fluid, such as saline. The flushing fluid flows from the proximal end of the catheter to distal tip 20 of the catheter and serves to efficiently couple ultrasonic energy into the sheath and then to the surrounding tissue”); and
a distal tip (Fig. 1 distal tip 20)
wherein the imaging window comprises a thickness and material exhibiting properties allowing for optimal transmission of acoustic signals from the one or more acoustic transducers to surrounding tissue during use of the imaging catheter by accounting for the acoustic coupling fluid, the outer sleeve, and surrounding environment ([0025] – “Imaging window 12 may be formed of a biocompatible flexible material…that minimizes acoustic loss”, one with ordinary skill in the art would find it obvious to account for the impedance of any material the acoustic waves would pass through to determine the material and the thickness of the imaging window to minimize acoustic loss),
wherein the pair of bearings further maintain the transducer unit, including the one or more acoustic transducers, concentrically aligned within the outer sleeve (Fig. 1, [0028] – “Non-uniform rotation of imaging core 100 may be minimized by aligning proximal bearing 120 and distal bearing 122 near the rotational center of imaging core 100 and fixing each bearing to the catheter”).
Conversely Waters does not teach the imaging assembly comprising: a shell comprising an imaging window; a transducer unit comprising one or more acoustic transducers encased within the shell and aligned with the imaging window of the shell;
the imaging assembly being operably associated with the torque shaft via direct engagement between one or more female connection members of a collet provided at a distal end of the torque shaft and one or more corresponding male connection members provided at a proximal end of the shell;
a distal tip bonded to a distal portion of the outer sleeve to thereby seal the fluid within the interior outer sleeve,
However Corl discloses the imaging assembly comprising: a shell comprising an imaging window (Fig. 4 and Fig. 5B shows the transducer completely enclosed within the housing and the aperture 128 therefore the housing can be interpreted as a shell and the aperture is interpreted as the imaging window);
a transducer unit comprising one or more acoustic transducers encased within the shell and aligned with the imaging window of the shell (Fig. 4 – ultrasound transducer 150 encased within housing 116, [0044] – “FIG. 4 shows a partial perspective view of transducer housing 116, including ultrasound transducer 150”, Figs. 4 and 5B show the transducer completely enclosed within the housing and aligned with the aperture 128);
Corl is an analogous art considering it is in the field of an ultrasound imaging catheter used within the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Waters to incorporate the shell encasing the transducer and including an imaging window of Corl to achieve the same results. One would have motivation to combine because it would keep the transducer dry and decrease the chances of corrosion of the transducer.
Conversely Waters and Corl do not teach the imaging assembly being operably associated with the torque shaft via direct engagement between one or more female connection members of a collet provided at a distal end of the torque shaft and one or more corresponding male connection members provided at a proximal end of the shell;
a distal tip bonded to a distal portion of the outer sleeve to thereby seal the fluid within the interior outer sleeve,
However Hamm discloses the imaging assembly being operably associated with the torque shaft via direct engagement between […] a collet provided at a distal end of the torque shaft and […] a proximal end of the shell (Col. 11 lines 7-10 – “the proximal end 27 (which is between about 1 to 2 cm in length) of ultrasonic guide wire 28 is connected to driver 20 by means of a collet assembly 32 and a sterile barrier 30”);
Waters discloses in [0027] - “Transducer housing 130 can include proximal journal 131…Proximal journal 131 can be bonded to torque coil 102 to enable rotation of transducer housing 130 when torque coil 102 rotates. Exemplary bonding techniques include soldering, brazing, and welding” and Hamm discloses in Col. 11 lines 10-17 – “Collet assembly 32, which includes an elastic first tube 13 joined to an elastic second tube 14, acts together with sterile barrier 30 to provide a means of mechanically holding the proximal end of ultrasonic guidewire 28 connected to driver 20. A compression fit between collet assembly 32 and outer tubular member 29 provides mechanical holding of ultrasonic guidewire 28.” Therefore Waters and Hamm both teach an attachment/connection between a drive shaft and an imaging assembly. Conversely Waters and Hamm do not explicitly teach the imaging assembly being operably associated with the torque shaft via direct engagement between one or more female connection members of a collet provided at a distal end of the torque shaft and one or more corresponding male connection members provided at a proximal end of the shell.
One with ordinary skill in the art would recognize male and female connecting members are commonly known and used to connect two things together. Therefore it would be obvious to one with ordinary skill in the art to provide female connection members to the collect/connector and provide male connection members to the imaging assembly to connect the two portions together.
Hamm is an analogous art considering it is in the field of an ultrasound imaging device used within the body.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Waters to incorporate the rotatable transducer of Hamm to achieve the same results. One would have motivation to combine because it would provide a 360 degree view around the guidewire and therefore provide a more detailed image.
Conversely Waters, Corl, and Hamm do not teach a distal tip bonded to a distal portion of the outer sleeve to thereby seal the fluid within the interior outer sleeve,
However Havel discloses a distal tip bonded to a distal portion of the outer sleeve to thereby seal the fluid within the interior outer sleeve (Fig. 2, [0051] – “lumen 172 is sealed on the tip side and on the side of the stationary mount piece that is closer to the control end to contain the coupling fluid within chamber 26”),
Havel is an analogous art considering it is in the field of an ultrasound imaging catheter.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Waters to incorporate the distal tip of Havel to achieve the same results. One would have motivation to combine because the distal tip of Havel allows for a channel to be formed for insertion of coupling fluid or gas to be released from the distal tip with the ability to also be sealed to contain coupling fluid within chamber.
Regarding claim 6, Waters, Corl, Hamm, and Havel disclose all the elements of the claimed invention as cited in claim 1.
Waters further discloses wherein the volume of fluid completely fills the gap, the fluid comprising an acoustic coupling fluid for carrying acoustic signals between the transducer unit ([0032] – “Imaging core lumen 11 can be preferably filled with a flushing fluid, such as saline. The flushing fluid flows from the proximal end of the catheter to distal tip 20 of the catheter and serves to efficiently couple ultrasonic energy into the sheath and then to the surrounding tissue.”), which is fully rotatable, and surrounding tissue to allow for subsequent generation of a full circumferential, 360-degree view of the surrounding tissue based, at least in part, on the acoustic signals ([0058] – “FIG. 7 shows baseline image 400 captured by the imaging core of a catheter of treatment area 401”, abstract – “an imaging core having an ultrasound transducer”, the baseline image and current image in Fig. 7 appear to show an image completely surrounding the catheter 402 therefore it can be interpreted there is full rotation of the torque coil to generate a 360-degree view of the surrounding tissue).
Regarding claim 8, Waters, Corl, Hamm, and Havel disclose all the elements of the claimed invention as cited in claim 1.
Conversely Waters does not teach wherein the shell includes a material comprising high mechanical stability and is sealed from an external environment to thereby prevent fluid ingress to an interior of the shell and into contact with the one or more acoustic transducers.
However Corl discloses wherein the shell includes a material comprising high mechanical stability ([0045] – “Housing 116 may be fabricated from stainless steel”) and is sealed from an external environment to thereby prevent fluid ingress to an interior of the shell and into contact with the one or more acoustic transducers (Fig. 5B shows the housing 116 and the aperture 128 of the housing forming a seal around the ultrasound transducer and therefore would prevent fluid ingress to the interior of the housing and into contact with the transducer).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Waters to incorporate the shell encasing the shell of Corl to achieve the same results. One would have motivation to combine because it would keep the transducer dry and decrease the chances of corrosion of the transducer.
Regarding claim 10, Waters, Corl, Hamm, and Havel disclose all the elements of the claimed invention as cited in claim 1.
Waters further discloses wherein the outer sleeve includes a main body and a distal tip member extending from the main body and defining a distal end of the outer sleeve (Fig. 1 the main body of the outer sleeve is the midshaft 10 and the imaging window 12, the distal tip 20 extends from the main body and defines a distal end of the outer sleeve), wherein the main body comprises a relatively high durometer elastomeric material and distal tip member comprises a relatively low durometer elastomeric material ([0025] – “Midshaft 10 may be formed of a biocompatible flexible material such as high-density polyethylene…Imaging window 12 may be formed of a biocompatible flexible material such as high-density polyethylene…Distal tip 20 may be formed of a low durometer material such as polyether block amide (Pebax®) or blend of Pebax grades such as Pebax 63D and 40D”).
Regarding claim 24, Waters, Corl, Hamm, and Havel disclose all the elements of the claimed invention as cited in claim 1.
Conversely Waters does not explicitly teach further comprising one or more connection members to which at least a proximal end of the outer sleeve is bonded to thereby seal the fluid within the interior of the outer sleeve.
However Corl discloses wherein the connection assembly further comprises one or more connection members to which at least a proximal end of the outer sleeve is bonded to thereby seal the fluid within the interior of the outer sleeve ([0032] – “Catheter/sheath assembly 112 includes a hub 118 supporting rotational interface 114 and provides a bearing surface and a fluid seal between rotating and non-rotating elements of catheter 102”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Waters to incorporate the connection assembly to seal the proximal end of the outer sleeve of Corl to achieve the same results. One would have motivation to combine because it would provide clean sterile saline to the interior of the outer sleeve and therefore prevent poor quality images.
Regarding claim 26, Waters, Corl, Hamm, and Havel disclose all the elements of the claimed invention as cited in claim 1.
Waters further discloses further comprising a cable assembly including one or more wires for carrying signals to and from the transducer unit for subsequent generation of a full circumferential, 360-degree view of surrounding tissue based, at least in part, on the signals ([0028] – “The electrical coupling enables sending and receiving of electrical signals along transmission line 110 to ultrasound transducer 190”, [0058] – “FIG. 7 shows baseline image 400 captured by the imaging core of a catheter of treatment area 401”, abstract – “an imaging core having an ultrasound transducer”, the baseline image and current image in Fig. 7 appear to show an image completely surrounding the catheter 402 therefore it can be interpreted there is full rotation of the torque coil to generate a 360-degree view of the surrounding tissue).
Regarding claim 27, Waters, Corl, Hamm, and Havel disclose all the elements of the claimed invention as cited in claims 1 and 26.
Conversely Waters does not teach wherein the cable assembly comprises at least one of a twisted pair of wires, a coaxial cable, and a flexible printed circuit cable, wherein each of which comprises a proximal interconnect portion of wires and a distal interconnect portion of wires.
However Hamm discloses wherein the cable assembly comprises at least one of a twisted pair of wires, a coaxial cable, and a flexible printed circuit cable, wherein each of which comprises a proximal interconnect portion of wires and a distal interconnect portion of wires (Col. 10 lines 61-64 – “A center conductor 103 of an inner coaxial cable 100 electrically connects to transducer assembly 23 and thus allows PZT 22 to produce ultrasonic energy.”, therefore the coaxial cable has a distal interconnect portion of wires to the transducer assembly and it would be obvious to one with ordinary skill in the art that there would be a proximal interconnect portion of wires to provide energy to the transducer at the distal interconnect).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the catheter of Waters to incorporate the coaxial cable with proximal and distal interconnect portions of Hamm to achieve the same results. One would have motivation to combine because it blocks any signal interference as signals are transmitted from the transducer to a computing device to process images.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RENEE C LANGHALS whose telephone number is (571)272-6258. The examiner can normally be reached Mon.-Thurs. alternate Fridays 8:30-6.
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/R.C.L./Examiner, Art Unit 3797
/CHRISTOPHER KOHARSKI/ Supervisory Patent Examiner, Art Unit 3797
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