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 Objections
Claims 1, 4, 9-11, and 18-19 objected to because of the following informalities:
Claim 1 recites the limitation “one or more ultrasound transducers disposed in the ultrasound channel, the ultrasound transducer(s) configured to produce ultrasound energy in a first direction; and one or more optical fibers disposed in the optical-energy channel, the optical fiber(s) having a first end configured to be optically coupled to a laser source and a second end” should read “one or more ultrasound transducers disposed in the ultrasound channel, the one or more ultrasound transducer(s) configured to produce ultrasound energy in a first direction; and one or more optical fibers disposed in the optical-energy channel, the one or more optical fiber(s) having a first end configured to be optically coupled to a laser source and a second end”.
Claim 4 recites the limitation “the optical window aligned with the second end of the optical fiber(s) such that the laser energy passes through the optical window” should read “the optical window aligned with the second end of the one or more optical fiber(s) such that the laser energy passes through the optical window”.
Claim 9 recites the limitation “optically coupled to the first end of the optical fiber(s)” should read “optically coupled to the first end of the one or more optical fiber(s)”.
Claim 10 recites the limitation “a laser optically coupled to the first end of the optical fiber(s); and a power supply electrically coupled to the ultrasound transducer(s)” should read “a laser optically coupled to the first end of the one or more optical fiber(s); and a power supply electrically coupled to the one or more ultrasound transducer(s)”.
Claim 11 recites the limitation “one or more ultrasound transducers disposed in the ultrasound channel, the ultrasound transducer(s) configured to produce ultrasound energy in a first direction” should read “one or more ultrasound transducers disposed in the ultrasound channel, the one or more ultrasound transducer(s) configured to produce ultrasound energy in a first direction”.
Claim 18 recites the limitation “rotating the shaft to align the ultrasound transducer(s) with the target volume” should read “rotating the shaft to align the one or more ultrasound transducer(s) with the target volume”.
Claim 19 recites the limitation “the optical fiber(s) and/or the laser is/are configured to direct the laser energy in a first direction” should read “the one or more optical fiber(s) and/or the laser is/are configured to direct the laser energy in a first direction”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3, 8, 12, and 15 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “about” in claims 2-3, 8, 12, and 15 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The angle range in the claim has been rendered indefinite because it is unclear how far or close the angle degree can be from the claimed range.
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, 4-6, 8-11, 13-17, and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Emelianov et al. (US Pub No. 2012/0271170).
Regarding claim 1, Emelianov teaches an ultrasound applicator comprising (figs. 1a-c, para. 0016; an intravascular photoacoustic imaging and therapeutic catheter):
a shaft having a proximal end, a tip, and a length measured between the proximal end and the tip with respect to an axis (paras. 0016 and 0061; one or more intravascular ultrasound imaging and therapeutic units comprising a proximal end and a distal end. Side fire fiber-based integrated IVUS/IVPA imaging catheter 100. The examiner notes that the catheter has a length measured between the proximal end and the tip.);
a plurality of channels defined in the shaft and extending from the proximal end of the shaft along at least a portion of the length of the shaft, the plurality of channels including an ultrasound channel and an optical-energy channel (figs. 1 a-c, element 102 and 106, paras. 0016 and 0061; one or more intravascular ultrasound imaging and therapeutic units comprising a proximal end and a distal end, wherein the distal end comprises one or more single-element ultrasound transducers, one or more ultrasound arrays or a combinations thereof, wherein the proximal end comprises a port connecting at least one ultrasound unit to a pulser/receiver; one or more optical units comprising a proximal end and a distal end combination, wherein the distal end comprises one or more optical fibers, one or more optical bundles or a combination of both and one or more light delivery systems mounted on one or more optical fibers or one or more optical bundles or both, wherein the proximal end comprises a port to couple at least one optical unit to a pulsed light source and/or to couple at least one optical unit to a CW and/or long-pulse light source. In one aspect the one or more optical units are incorporated longitudinally in or about the catheter. In another aspect the one or more ultrasound units are incorporated longitudinally in or about the catheter. The examiner notes that the catheter comprises two channels/units ultrasonic and optical);
one or more ultrasound transducers disposed in the ultrasound channel, the ultrasound transducer(s) configured to produce ultrasound energy in a first direction (fig. 2A, paras. 0061-0062; The ultrasound transducer 108 is fixed face to fiber 102 as it is shown in FIG. 1C using the shrinking tubing in a longitudinal position excluding direct interaction of ultrasound beam 112 with the light delivery system 102 and 104. The light divergence after the catheter was measured to be 26.degree. while angle between light 110 and ultrasound beams 112 was 24.degree. The examiner notes that the ultrasound energy is directed in a direction perpendicular to the axis of the catheter (first direction).); and
one or more optical fibers disposed in the optical-energy channel, the optical fiber(s) having a first end configured to be optically coupled to a laser source and a second end configured to direct laser energy at a predetermined angle relative to the first direction (fig. 2A, paras. 0016 and 0061-0063; one or more optical units comprising a proximal end and a distal end combination, wherein the distal end comprises one or more optical fibers, one or more optical bundles or a combination of both and one or more light delivery systems mounted on one or more optical fibers or one or more optical bundles or both, wherein the proximal end comprises a port to couple at least one optical unit to a pulsed light source and/or to couple at least one optical unit to a CW and/or long-pulse light source. The light divergence after the catheter was measured to be 26.degree. while angle between light 110 and ultrasound beams 112 was 24.degree. The examiner notes that the optical energy is directed in a direction parallel to the optical axis as shown in figure 2 and the angle between the angle between the light and the ultrasound beam is 24 degrees).
Regarding claim 4, Emelianov teaches the ultrasound applicator of claim 1, further comprising an optical window defined in the shaft, the optical window aligned with the second end of the optical fiber(s) such that the laser energy passes through the optical window, the optical window optically transparent to one or more wavelengths of the laser energy (para. 0019; An optically transparent tube sealed on the distal end is mounted on the distal end of the one or more optical units as a separation between the micro-optics and imaged tissue. The tube is filled by a medium such as saline or water to reduce the radiation loss during light transmission. In another aspect a light delivery system utilizes the total internal effect. The distal end of optical fibers is polished at a certain angle to redirect light to almost near-right angle relative with respect of the longitudinal axis of the catheter. The optically transparent tube sealed on the distal end is mounted on one or more optical units hermetically to trap a medium such as gas near the distal end of optical units to create a difference in the refractive index between the optical unit's material and the entrapped medium. In both aspects the optically transparent tubes in both designs of the present invention is also mounted on the distal end of the one or more optical units to prevent mechanical damage of the artery.).
Regarding claim 5, Emelianov teaches the ultrasound applicator of claim 1, wherein: the predetermined angle is a first predetermined angle (fig. 2A, para. 0061; the examiner notes that the ultrasound energy is emitted in a first direction perpendicular to the optical axis and the optical energy is emitted in a second direction parallel to the optical axis, the angle between the ultrasound energy and the optical energy is 24 degrees.), and the ultrasound applicator further comprises a mirror configured to reflect the laser energy at a second predetermined angle relative to the first direction (figs. 2A-B, paras. 0062-0063; the micro-optic-based integrated IVUS/IVPA imaging catheter, the distal end of the optical fiber is polished flat and is perpendicular to the optical axis of the fiber, and a small mirror is used to rotate light. The mirror is attached to the fiber using a custom-made brass fixture comprising of a thin-wall cut along pipe and soldered to the pipe is a bended plate. The resulting angle between optical axis of the fiber and the plate with the glued mirror is chosen for better overlapping of light and ultrasound beams. The ultrasound transducer 206 was fixed face from fiber 202 using shrinking tubing 204 in the position resulted the maximum overlap of the ultrasound 214 and light beams 212. The angle between fiber's 202 optical axes and mirror 210 is approximately 52.degree. The examiner notes that the optical energy is emitted in a direction parallel to the optical axis and then reflected by a mirror to be directed relative to the first direction of the ultrasound energy to make the angle between the ultrasound and optical energy less than the first angle, thus, both energies overlap.).
Regarding claim 6, Emelianov teaches the ultrasound applicator of claim 5, wherein the mirror is disposed in the optical-energy channel (fig. 2A, paras. 0062-0063; the distal end of the optical fiber is polished flat and is perpendicular to the optical axis of the fiber, and a small mirror is used to rotate light. The mirror is attached to the fiber using a custom-made brass fixture comprising of a thin-wall cut along pipe and soldered to the pipe is a bended plate.).
Regarding claim 8, Emelianov teaches the ultrasound applicator of claim 1, wherein the predetermined angle has a range of about +60 degrees to about -60 degrees whereby the ultrasound energy and the laser energy are directed towards a same side of the shaft (figs. 2A-B, paras. 0062-0063; The angle between fiber's 202 optical axes and mirror 210 is approximately 52.degree.. An angle between ultrasound and optical axes was estimated to be approximately 14.degree.. Since the optical fiber 202 with NA of 0.39 and core refraction coefficient of 1.457 is located in water, the light divergence of the catheter comprises 17.degree. The resulting angle between optical axis of the fiber and the plate with the glued mirror is chosen for better overlapping of light and ultrasound beams. The examiner notes that the predetermined angle between the overlapping light and ultrasound beams is about 0 degrees which is within the range of about +60 degrees to about -60 degrees, where both beams are directed toward the same direction.).
Regarding claim 9, Emelianov teaches the ultrasound applicator of claim 1, further comprising a laser disposed in the optical-energy channel and optically coupled to the first end of the optical fiber(s) (para. 0016; one or more optical units comprising a proximal end and a distal end combination, wherein the distal end comprises one or more optical fibers, one or more optical bundles or a combination of both and one or more light delivery systems mounted on one or more optical fibers or one or more optical bundles or both, wherein the proximal end comprises a port to couple at least one optical unit to a pulsed light source and/or to couple at least one optical unit to a CW and/or long-pulse light source).
Regarding claim 10, Emelianov teaches a medical device comprising: the ultrasound applicator of claim 1; a laser optically coupled to the first end of the optical fiber(s); and a power supply electrically coupled to the ultrasound transducer(s) (para. 0016; one or more intravascular ultrasound imaging and therapeutic units comprising a proximal end and a distal end, wherein the distal end comprises one or more single-element ultrasound transducers, one or more ultrasound arrays or a combinations thereof, wherein the proximal end comprises a port connecting at least one ultrasound unit to a pulser/receiver; one or more optical units comprising a proximal end and a distal end combination, wherein the distal end comprises one or more optical fibers, one or more optical bundles or a combination of both and one or more light delivery systems mounted on one or more optical fibers or one or more optical bundles or both, wherein the proximal end comprises a port to couple at least one optical unit to a pulsed light source and/or to couple at least one optical unit to a CW and/or long-pulse light source, an ultrasound pulser/receiver connected to the proximal end of the one or more ultrasound imaging and therapeutic units, a pulsed light source connected to the proximal end of the one or more optical units having a pulsed laser fluence, a CW light source connected to the proximal end of one or more optical units having a CW laser fluence, and an imager connected to the proximal end of the unit to capture one or more ultrasound, photoacoustic and elasticity images, wherein a majority of a laser and ultrasound energy is Omni-directionally directed at a target tissue and the imager is capable both of a distribution reconstruction of an ultrasound impedance, a shear elastic modulus and an optical absorption in an imaged target tissue cross-section and of performing an optical and/or an acoustic therapy.).
Regarding claim 11, Emelianov teaches an ultrasound applicator comprising (figs. 1a-c, para. 0016; an intravascular photoacoustic imaging and therapeutic catheter):
a shaft having a proximal end, a tip, and a length measured between the proximal end and the tip with respect to an axis (paras. 0016 and 0061; one or more intravascular ultrasound imaging and therapeutic units comprising a proximal end and a distal end. Side fire fiber-based integrated IVUS/IVPA imaging catheter 100. The examiner notes that the catheter has a length measured between the proximal end and the tip.);
a plurality of channels defined in the shaft and extending from the proximal end of the shaft along at least a portion of the length of the shaft, the plurality of channels including an ultrasound channel and an optical-energy channel (figs. 1 a-c, element 102 and 106, paras. 0016 and 0061; one or more intravascular ultrasound imaging and therapeutic units comprising a proximal end and a distal end, wherein the distal end comprises one or more single-element ultrasound transducers, one or more ultrasound arrays or a combinations thereof, wherein the proximal end comprises a port connecting at least one ultrasound unit to a pulser/receiver; one or more optical units comprising a proximal end and a distal end combination, wherein the distal end comprises one or more optical fibers, one or more optical bundles or a combination of both and one or more light delivery systems mounted on one or more optical fibers or one or more optical bundles or both, wherein the proximal end comprises a port to couple at least one optical unit to a pulsed light source and/or to couple at least one optical unit to a CW and/or long-pulse light source. In one aspect the one or more optical units are incorporated longitudinally in or about the catheter. In another aspect the one or more ultrasound units are incorporated longitudinally in or about the catheter. The examiner notes that the catheter comprises two channels/units ultrasonic and optical);
one or more ultrasound transducers disposed in the ultrasound channel, the ultrasound transducer(s) configured to produce ultrasound energy in a first direction (fig. 2A, paras. 0061-0062; The ultrasound transducer 108 is fixed face to fiber 102 as it is shown in FIG. 1C using the shrinking tubing in a longitudinal position excluding direct interaction of ultrasound beam 112 with the light delivery system 102 and 104. The light divergence after the catheter was measured to be 26.degree. while angle between light 110 and ultrasound beams 112 was 24.degree. The examiner notes that the ultrasound energy is directed in a direction perpendicular to the axis of the catheter (first direction).); and
laser disposed in the optical-energy channel, the laser configured to direct laser energy at a predetermined angle relative to the first direction (fig. 2A, paras. 0016 and 0061-0063; one or more optical units comprising a proximal end and a distal end combination, wherein the distal end comprises one or more optical fibers, one or more optical bundles or a combination of both and one or more light delivery systems mounted on one or more optical fibers or one or more optical bundles or both, wherein the proximal end comprises a port to couple at least one optical unit to a pulsed light source and/or to couple at least one optical unit to a CW and/or long-pulse light source. The light divergence after the catheter was measured to be 26.degree. while angle between light 110 and ultrasound beams 112 was 24.degree. The examiner notes that the optical energy is directed in a direction parallel to the optical axis as shown in figure 2 and the angle between the angle between the light and the ultrasound beam is 24 degrees).
Regarding claim 13, Emelianov teaches the ultrasound applicator of claim 11, further comprising an optical window defined in the shaft, the optical window aligned with the laser such that the laser energy passes through the optical window, the optical window optically transparent to one or more wavelengths of the laser energy (para. 0019; An optically transparent tube sealed on the distal end is mounted on the distal end of the one or more optical units as a separation between the micro-optics and imaged tissue. The tube is filled by a medium such as saline or water to reduce the radiation loss during light transmission. In another aspect a light delivery system utilizes the total internal effect. The distal end of optical fibers is polished at a certain angle to redirect light to almost near-right angle relative with respect of the longitudinal axis of the catheter. The optically transparent tube sealed on the distal end is mounted on one or more optical units hermetically to trap a medium such as gas near the distal end of optical units to create a difference in the refractive index between the optical unit's material and the entrapped medium. In both aspects the optically transparent tubes in both designs of the present invention is also mounted on the distal end of the one or more optical units to prevent mechanical damage of the artery.).
Regarding claim 14, Emelianov teaches the ultrasound applicator of claim 11, wherein: the predetermined angle is a first predetermined angle (fig. 2A, para. 0061; the examiner notes that the ultrasound energy is emitted in a first direction perpendicular to the optical axis and the optical energy is emitted in a second direction parallel to the optical axis, the angle between the ultrasound energy and the optical energy is 24 degrees.), and the ultrasound applicator further comprises a mirror configured to reflect the laser energy at a second predetermined angle relative to the first direction (figs. 2A-B, paras. 0062-0063; the micro-optic-based integrated IVUS/IVPA imaging catheter, the distal end of the optical fiber is polished flat and is perpendicular to the optical axis of the fiber, and a small mirror is used to rotate light. The mirror is attached to the fiber using a custom-made brass fixture comprising of a thin-wall cut along pipe and soldered to the pipe is a bended plate. The resulting angle between optical axis of the fiber and the plate with the glued mirror is chosen for better overlapping of light and ultrasound beams. The ultrasound transducer 206 was fixed face from fiber 202 using shrinking tubing 204 in the position resulted the maximum overlap of the ultrasound 214 and light beams 212. The angle between fiber's 202 optical axes and mirror 210 is approximately 52.degree. The examiner notes that the optical energy is emitted in a direction parallel to the optical axis and then reflected by a mirror to be directed relative to the first direction of the ultrasound energy to make the angle between the ultrasound and optical energy less than the first angle, thus, both energies overlap.).
Regarding claim 15, Emelianov teaches the ultrasound applicator of claim 11, wherein the predetermined angle has a range of about +60 degrees to about -60 degrees whereby the ultrasound energy and the laser energy are directed towards a same side of the shaft (figs. 2A-B, paras. 0062-0063; The angle between fiber's 202 optical axes and mirror 210 is approximately 52.degree.. An angle between ultrasound and optical axes was estimated to be approximately 14.degree.. Since the optical fiber 202 with NA of 0.39 and core refraction coefficient of 1.457 is located in water, the light divergence of the catheter comprises 17.degree. The resulting angle between optical axis of the fiber and the plate with the glued mirror is chosen for better overlapping of light and ultrasound beams. The examiner notes that the predetermined angle between the overlapping light and ultrasound beams is about 0 degrees which is within the range of about +60 degrees to about -60 degrees, where both beams are directed toward the same direction.).
Regarding claim 16, Emelianov teaches a method for performing thermal therapy, comprising:
positioning an ultrasound applicator relative to a target volume in a mammal (para. 0072; The distal end of the integrated catheter 706 was inserted into the lumen and placed at the center of the vessel-mimicking phantom 710.);
directing laser energy towards an obstruction located between the ultrasound applicator and the target volume, the laser energy emitted from one or more optical fibers and/or a laser disposed in an optical-energy channel defined in a shaft of the ultrasound applicator (paras. 0012, 0016, and 0023; the integrated catheters, the light delivery systems were designed to direct the light into the area or tissues imaged by the ultrasound transducer. In addition to that, the CW radiation utilized for radiation therapy is also delivered in the same area. Finally, an intravascular acoustic therapy can be performed using one or more ultrasound units that deliver the acoustic radiation in the desired area of the artery. one or more optical units comprising a proximal end and a distal end combination, wherein the distal end comprises one or more optical fibers, one or more optical bundles or a combination of both and one or more light delivery systems mounted on one or more optical fibers or one or more optical bundles or both, wherein the proximal end comprises a port to couple at least one optical unit to a pulsed light source and/or to couple at least one optical unit to a CW and/or long-pulse light source, the one or more optical units can irradiate tissues by CW or long light pulses to perform an optical therapy.); reducing a size of the obstruction (para. 0023; the one or more optical units can irradiate tissues by CW or long light pulses to perform an optical therapy); and
after the size of the obstruction is reduced, directing ultrasound energy towards the target volume, the ultrasound energy produced by one or more ultrasound transducers disposed in an ultrasound channel defined in the shaft of the ultrasound applicator (paras. 0012, 0016, and 0023; one or more ultrasound arrays or a combinations thereof, wherein the proximal end comprises a port connecting at least one ultrasound unit to a pulser/receiver. the integrated catheters, the light delivery systems were designed to direct the light into the area or tissues imaged by the ultrasound transducer. In addition to that, the CW radiation utilized for radiation therapy is also delivered in the same area. Finally, an intravascular acoustic therapy can be performed using one or more ultrasound units that deliver the acoustic radiation in the desired area of the artery. In yet another aspect the optical and the acoustic therapy can be performed either simultaneously or separately. The examiner notes that the integrated catheter can be used for therapy, where the optical energy is directed to target (vascular obstruction) for radiation therapy and then the ultrasound energy is directed to the same target to provide acoustic therapy.).
Regarding claim 17, Emelianov teaches the method of claim 16, wherein the obstruction comprises a calcification (paras. 0054-0055; Cardiovascular diseases represent a significant clinical problem with more than a million deaths annually due to problems associated with the arteries. The most common reason of the mortality is the formation and development of atherosclerotic plaques on artery's walls. These plaques narrow the cross-section of the vessels thus obstructing the normal blood flow..sup.27 In addition, the vulnerability of the atherosclerotic plaques depends on their composition).
Regarding claim 19, Emelianov teaches the method of claim 16, wherein: the optical fiber(s) and/or the laser is/are configured to direct the laser energy in a first direction, and the method further comprises reflecting the laser energy, with a mirror, in a second direction towards the obstruction (figs. 2A-B, paras. 0062-0063; the micro-optic-based integrated IVUS/IVPA imaging catheter, the distal end of the optical fiber is polished flat and is perpendicular to the optical axis of the fiber, and a small mirror is used to rotate light. The mirror is attached to the fiber using a custom-made brass fixture comprising of a thin-wall cut along pipe and soldered to the pipe is a bended plate. The resulting angle between optical axis of the fiber and the plate with the glued mirror is chosen for better overlapping of light and ultrasound beams. The ultrasound transducer 206 was fixed face from fiber 202 using shrinking tubing 204 in the position resulted the maximum overlap of the ultrasound 214 and light beams 212. The angle between fiber's 202 optical axes and mirror 210 is approximately 52.degree. The examiner notes that the optical energy is emitted in a direction parallel to the optical axis and then reflected by a mirror to be directed relative to the first direction of the ultrasound energy to make the angle between the ultrasound and optical energy less than the first angle, thus, both energies overlap.).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2-3, 12, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Emelianov et al. (US Pub No. 2012/0271170) in the view of Nogawa (JP 2005/237827).
Regarding claim 2, Emelianov teaches the ultrasound applicator of claim 1, however, fails to explicitly teach wherein the predetermined angle has a range of about 120 degrees to about 240 degrees whereby the ultrasound energy is directed towards a first side of the shaft and the laser energy is directed towards a second side of the shaft.
Nogawa, in the same field of endeavor, teaches the predetermined angle has a range of about 120 degrees to about 240 degrees whereby the ultrasound energy is directed towards a first side of the shaft and the laser energy is directed towards a second side of the shaft (fig. 3, paras. 0060-0064; A mounting housing 44 formed of a plastic material or the like is fixed to the distal end portion of the drive shaft 30. In this example, the mounting housing 44 has an H-shaped cross section and functions as distance measuring means (ranging means) on the upper flat portion 44a. In this example, an ultra-small and flat ultrasonic transducer 26 is attached and fixed. As is well known, the ultrasonic transducer 26 includes a transmitting unit and a receiving unit, transmits ultrasonic waves from the transmitting unit, and receives reflected waves at the receiving unit. In this example, which functions as an energy irradiating means, is attached and fixed to the lower flat portion 44b of the mounting housing 44 so that the front end portion (energy emitting end portion) 28a of the optical fiber 28 faces. By doing so, the ultrasonic transducer 26 and the optical fiber 28 are disposed at a position just opposite to each other by 180 °. The examiner notes that the ultrasound beam and the optical beam are directed to two different directions opposite to each other by 180°.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the direction of the catheter of Emelianov to adopt the optical arrangement (including the opposite initial beam orientation and the mirror of Nogawa to provide ultrasound energy directed towards a first side of the shaft and laser energy directed towards a second side of the shaft at 180 degrees relative to the first direction because this arrangement would facilitates mounting and fixation of the optical fiber within the catheter shaft, permits the fiber to remain substantially straight through the catheter, and through the use of a mirror, still directs the laser energy laterally toward the treatment site as disclosed within Nogawa in paras. 0060-0064.
Regarding claim 3, Emelianov teaches the ultrasound applicator of claim 1, however, fails to explicitly teach wherein the predetermined angle is about 180 degrees.
Nogawa, in the same field of endeavor, teaches wherein the predetermined angle is about 180 degrees (fig. 3, paras. 0060-0064; A mounting housing 44 formed of a plastic material or the like is fixed to the distal end portion of the drive shaft 30. In this example, the mounting housing 44 has an H-shaped cross section and functions as distance measuring means (ranging means) on the upper flat portion 44a. In this example, an ultra-small and flat ultrasonic transducer 26 is attached and fixed. As is well known, the ultrasonic transducer 26 includes a transmitting unit and a receiving unit, transmits ultrasonic waves from the transmitting unit, and receives reflected waves at the receiving unit. In this example, which functions as an energy irradiating means, is attached and fixed to the lower flat portion 44b of the mounting housing 44 so that the front end portion (energy emitting end portion) 28a of the optical fiber 28 faces. By doing so, the ultrasonic transducer 26 and the optical fiber 28 are disposed at a position just opposite to each other by 180 °. The examiner notes that the ultrasound beam and the optical beam are directed to two different directions opposite to each other by 180°.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the catheter of Emelianov to adopt the optical arrangement (including the opposite initial beams orientation and the mirror) of Nogawa to provide ultrasound energy directed towards a first side of the shaft and laser energy directed towards a second side of the shaft at 180 degrees relative to the first direction because this arrangement would facilitates mounting and fixation of the optical fiber within the catheter shaft, permits the fiber to remain substantially straight through the catheter, and through the use of a mirror, still directs the laser energy laterally toward the treatment site as disclosed within Nogawa in paras. 0060-0064.
Regarding claim 12, Emelianov teaches the ultrasound applicator of claim 11, however, fails to explicitly teach wherein the predetermined angle has a range of about 120 degrees to about 240 degrees whereby the ultrasound energy is directed towards a first side of the shaft and the laser energy is directed towards a second side of the shaft.
Nogawa, in the same field of endeavor, teaches the predetermined angle has a range of about 120 degrees to about 240 degrees whereby the ultrasound energy is directed towards a first side of the shaft and the laser energy is directed towards a second side of the shaft (fig. 3, paras. 0060-0064; A mounting housing 44 formed of a plastic material or the like is fixed to the distal end portion of the drive shaft 30. In this example, the mounting housing 44 has an H-shaped cross section and functions as distance measuring means (ranging means) on the upper flat portion 44a. In this example, an ultra-small and flat ultrasonic transducer 26 is attached and fixed. As is well known, the ultrasonic transducer 26 includes a transmitting unit and a receiving unit, transmits ultrasonic waves from the transmitting unit, and receives reflected waves at the receiving unit. In this example, which functions as an energy irradiating means, is attached and fixed to the lower flat portion 44b of the mounting housing 44 so that the front end portion (energy emitting end portion) 28a of the optical fiber 28 faces. By doing so, the ultrasonic transducer 26 and the optical fiber 28 are disposed at a position just opposite to each other by 180 °. The examiner notes that the ultrasound beam and the optical beam are directed to two different directions opposite to each other by 180°.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the catheter of Emelianov to adopt the optical arrangement (including the opposite initial beam orientation and the mirror of Nogawa to provide ultrasound energy directed towards a first side of the shaft and laser energy directed towards a second side of the shaft at 180 degrees relative to the first direction because this arrangement would facilitates mounting and fixation of the optical fiber within the catheter shaft, permits the fiber to remain substantially straight through the catheter, and through the use of a mirror, still directs the laser energy laterally toward the treatment site as disclosed within Nogawa in paras. 0060-0064.
Regarding claim 18, Emelianov teaches the method of claim 16, after the size of the obstruction is reduced, rotating the shaft to align the ultrasound transducer(s) with the target volume (paras. 0012 and 0016; aspects the integrated device may rotate around its longitudinal axis inside a lumen driven by one or multiple motors operated with the imager.).
However, fails to explicitly teach wherein: the laser energy is directed towards a first side of the shaft, the ultrasound energy is directed towards a second side of the shaft.
Nogawa, in the same field of endeavor, teaches the laser energy is directed towards a first side of the shaft, the ultrasound energy is directed towards a second side of the shaft (fig. 3, paras. 0060-0064; A mounting housing 44 formed of a plastic material or the like is fixed to the distal end portion of the drive shaft 30. In this example, the mounting housing 44 has an H-shaped cross section and functions as distance measuring means (ranging means) on the upper flat portion 44a. In this example, an ultra-small and flat ultrasonic transducer 26 is attached and fixed. As is well known, the ultrasonic transducer 26 includes a transmitting unit and a receiving unit, transmits ultrasonic waves from the transmitting unit, and receives reflected waves at the receiving unit. In this example, which functions as an energy irradiating means, is attached and fixed to the lower flat portion 44b of the mounting housing 44 so that the front end portion (energy emitting end portion) 28a of the optical fiber 28 faces. By doing so, the ultrasonic transducer 26 and the optical fiber 28 are disposed at a position just opposite to each other by 180 °. The examiner notes that the ultrasound beam and the optical beam are directed to two different directions opposite to each other by 180°.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the catheter of Emelianov to adopt the optical arrangement (including the opposite initial beam orientation and the mirror of Nogawa to provide ultrasound energy directed towards a first side of the shaft and laser energy directed towards a second side of the shaft at 180 degrees relative to the first direction because this arrangement would facilitates mounting and fixation of the optical fiber within the catheter shaft, permits the fiber to remain substantially straight through the catheter, and through the use of a mirror, still directs the laser energy laterally toward the treatment site as disclosed within Nogawa in paras. 0060-0064.
Claim(s) 7 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Emelianov et al. (US Pub No. 2012/0271170) in the view of Hannaford et al (US Patent No. 10,092,355).
Regarding claim 7, Emelianov teaches ultrasound applicator of claim 5, however fails to explicitly teach wherein the mirror is electromechanically actuated such that the second predetermined angle is variable.
Hannaford, in the same field of endeavor, teaches wherein the mirror is electromechanically actuated such that the second predetermined angle is variable (Col 4, lines 4-25 and col 10, lines 42-63; For example, the surgical probe could include a mirror and an actuator configured to adjust, affect, or otherwise control a location and/or angle of the mirror such that the location and/or angle of the beam of illumination relative to the surgical probe (e.g., relative to the probe head of the surgical probe) and/or relative to biological tissue proximate the probe head could be controlled.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify mirror of Emelianov to adopt the electromechanically actuated mirror of Hannaford to provide a mirror that is electromechanically actuated such that the second predetermined angle is variable because this modification would adjusting, affecting, or otherwise controlling a location and/or angle of the mirror such that the location and/or angle of the beam of illumination relative to the surgical probe (e.g., relative to the probe head of the surgical probe) and/or relative to biological tissue can be controlled as disclosed within Hannaford in col 4, lines 4-25 and col 10, lines 42-63.
Regarding claim 20, Emelianov teaches the method of claim 19, however fails to explicitly teach electromechanically pivoting the mirror to adjust the second direction.
Hannaford, in the same field of endeavor, teaches electromechanically pivoting the mirror to adjust the second direction (Col 4, lines 4-25 and col 10, lines 42-63; For example, the surgical probe could include a mirror and an actuator configured to adjust, affect, or otherwise control a location and/or angle of the mirror such that the location and/or angle of the beam of illumination relative to the surgical probe (e.g., relative to the probe head of the surgical probe) and/or relative to biological tissue proximate the probe head could be controlled.).
It would have been obvious to an ordinary skilled in the art before the invention was made to modify mirror of Emelianov to adopt the electromechanically actuated mirror of Hannaford to provide a mirror that is electromechanically pivoted such that the second predetermined angle is variable because this modification would adjusting, affecting, or otherwise controlling a location and/or angle of the mirror such that the location and/or angle of the beam of illumination relative to the surgical probe (e.g., relative to the probe head of the surgical probe) and/or relative to biological tissue can be controlled as disclosed within Hannaford in col 4, lines 4-25 and col 10, lines 42-63.
Conclusion
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/ZAINAB MOHAMMED ALDARRAJI/ Patent Examiner, Art Unit 3797
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