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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9, 11-13 and 22 in the reply filed on 9/12/2025 is acknowledged. Claims 14-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9/12/2025.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
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 and 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0162489 to Richards-Kortum (Kortum).
In reference to at least claim 1
Kortum discloses a device for performing a surgical procedure (e.g. “Fluorescence spectral data acquired from tissues in vivo or in vitro is processed in accordance with a multivariate statistical method to achieve the ability to probabilistically classify tissue in a diagnostically useful manner”, abstract), the device comprising: a shaft extending from a proximal portion to a distal portion (e.g. optical fiber probe 101 contains a shaft extending from a proximal portion to a distal portion, Fig. 1 ); a light conductor extending at least partially through the shaft to be exposed at the distal portion (e.g. fibers 106 and 107 deliver excitation light to the tissue surface, para. [0067]); and a damage mitigator positioned to receive light from the light conductor to discharge the light from the device (e.g. quartz shield 112 is the “damage mitigator”, Fig. 1, para. [0067]), wherein the damage mitigator is configured to protect the light conductor from incoming energy comprising at least one of laser energy, thermal energy and kinetic energy (e.g. “A quartz shield 112 is placed at the tip of the probe 101 to provide a substantially fixed distance between the fibers and the tissue surface, so fluorescence intensity can be reported in calibrated units.”, para. [0067]).
In reference to at least claim 3
Kortum discloses the light conductor includes a distal end (e.g. fibers 106 and 107 includes a distal end, Fig. 1); and the shaft comprises a distal end face including an opening to receive the distal end of the light conductor (e.g. probe 101 which includes a shaft has a distal end face that has “openings” that receive the distal end of the fibers 106 and 107, Fig. 1).
Claim(s) 1,3-9 and 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 5,304,173 to Kittrell et al. (Kittrell).
In reference to at least claim 1
Kittrell discloses a device for performing a surgical procedure (e.g. “A laser catheter is disclosed wherein optical fibers carrying laser light are mounted in a catheter for insertion into an artery to provide controlled delivery of a laser beam for percutaneous intravascular laser treatment of atherosclerotic disease.” abstract), the device comprising: a shaft extending from a proximal portion to a distal portion (e.g. catheter body 16 includes a shaft, Fig. 1); a light conductor extending at least partially through the shaft to be exposed at the distal portion (e.g. optical fibers 20a,b,b’,c,c’, Fig. 1); and a damage mitigator positioned to receive light from the light conductor to discharge the light from the device (e.g. optical shield 12 “damage mitigator” receives light from the optical fibers, Fig. 1), wherein the damage mitigator is configured to protect the light conductor from incoming energy comprising at least one of laser energy, thermal energy and kinetic energy (e.g. “The protective optical shield mechanically displaces the blood and also protects the fiber(s) from the intraarterial contents. The fiber(s) are anchored so that there is an appropriate distance between the output end of the fiber(s) and the tip of the shield. The catheter and shield are sealed watertight, preventing blood from coming into contact with the internal components. The intervening space may be filled with fluid, or optical surfaces may be optically contacted, or they may be anti-reflection coated to reduce Fresnel reflections and maximize transmitted light.”, Col. 5, ll. 7-17).
In reference to at least claim 3
Kittrell discloses the light conductor includes a distal end (e.g. optical fibers 20a,b,b’,c,c’ include a distal end, Fig. 1); and the shaft comprises a distal end face including an opening to receive the distal end of the light conductor (e.g. optical fibers 20a,b,b’,c,c’, are located in “openings” within shaft of catheter body 16, Figs. 1).
In reference to at least claim 4
Kittrell discloses wherein the damage mitigator comprises a lumen extending into the distal end face (e.g. optical shield 12 has a lumen that extends into the distal end face of the shaft of catheter body 16, Figs. 1-2, 7A-7D) to receive the distal end of the light conductor (e.g. “ The optical shield 12 may be secured to catheter body 16 by a butt joint 13a, as in FIG. 1, or by a tapered joint 13, as in FIG. 2. The joint may be overlapping if desired. A bonding agent or wrapping material may be used to secure the joints 13 or 13a.”, Col. 8, ll. 1-5), wherein the distal end of the light conductor is positioned a distance from the distal end face of the shaft within the lumen (e.g. optical fibers 20a,b,b’,c,c’ are positioned a distance from the shaft of catheter body 16 and into the lumen of optical shield 12, Figs. 1-2; “Several fibers can be precisely positioned at different locations within the shield”, Col. 4, ll. 64-65; “Optical fibers 20a,b,b',c,c' are disposed within the catheter body 16 and have a distal termination in the vicinity of the optical shield 12. The corresponding proximal ends 40a,b,b',c,c' of optical fibers 20a,b,b',c,c' are secured by the fiber optic coupler 46. The distal ends of the optical fibers 20a-c' are secured in the material of plug 11. The optical fibers 20a-c' may be angled with respect to the axis of symmetry, as shown in FIG. 1, or they may be straight and coaxial with the distal end of the laser catheter 10, as shown in the longitudinal section FIG. 2. “, Col. 8, ll. 6-16).
In reference to at least claim 5
Kittrell discloses wherein the light conductor has a first diameter (e.g. Optical fibers 20a,b,b',c,c' have a first diameter, Figs. 1-2) and the lumen has a second diameter (e.g. the lumen of optical shield 12 has a second diameter, Figs. 1-2), wherein the second diameter is different than the first diameter and the distance is fixed (e.g. the second diameter of the optical shield is different than the diameter of the optical fibers, Figs. 1-2 and the optical fibers 20a,b,b’,c,c’ are positioned a distance into the lumen of optical shield 12, Figs. 1-2; “Several fibers can be precisely positioned at different locations within the shield”, Col. 4, ll. 64-65; “Optical fibers 20a,b,b',c,c' are disposed within the catheter body 16 and have a distal termination in the vicinity of the optical shield 12. The corresponding proximal ends 40a,b,b',c,c' of optical fibers 20a,b,b',c,c' are secured by the fiber optic coupler 46. The distal ends of the optical fibers 20a-c' are secured in the material of plug 11. The optical fibers 20a-c' may be angled with respect to the axis of symmetry, as shown in FIG. 1, or they may be straight and coaxial with the distal end of the laser catheter 10, as shown in the longitudinal section FIG. 2. “, Col. 8, ll. 6-16).
In reference to at least claim 6
Kittrell discloses wherein the damage mitigator comprises an optical device (e.g. optical shield 12, Fig. 1) comprising: a first side facing the light conductor (e.g. optical shield 12 has a first side that faces the optical fibers 20a,b,b’,c,c’, Fig. 1); and a second side facing away from the light conductor (e.g. optical shield 12 has a second side that faces away from optical fibers 20a,b,b’,c,c’, Fig. 1); wherein the optical device is configured to allow light from the light conductor to pass through (e.g. light from optical fibers 20a,b,b’,c,c’ pass through, Fig. 1); and wherein the optical device is configured to reflect light at the second side (e.g. The intervening space may be filled with fluid, or optical surfaces may be optically contacted, or they may be anti-reflection coated to reduce Fresnel reflections and maximize transmitted light.”, Col. 5, ll. 7-17; “Addition of an anti-reflection coating 25b to this optically polished surface 23, and to one or both surfaces 25a,c of the optical shield 12, will reduce Fresnel reflections of the beam 29. Fresnel reflections reduce delivered laser power, and the reflected beams may damage the plug or irradiate tissue in an unintended location.”, Col. 8, l. 64-Col. 9, l. 2).
In reference to at least claim 7
Kittrell discloses wherein the optical device comprises at least one of a prism and a mirror coating (e.g. prismatic surface or mirror 164; “Several fibers can be precisely positioned at different locations within the shield. Lenses or mirrors, and mechanical or optical aiming and focusing devices can be mounted inside of the shield.”, Col. 4, ll. 64-68).
In reference to at least claim 8
Kittrell discloses wherein the damage mitigator comprises a shield (e.g. optical shield 12), the shield being formed of a material that is light transmitting and harder than the material of the light conductor (e.g. “The shield may be in the form of a glass, fused silica, sapphire or other transparent member.”, Col. 4, ll. 58-59), wherein the shield comprises a sapphire body (e.g. “The shield may be in the form of a glass, fused silica, sapphire or other transparent member.”, Col. 4, ll. 58-59) and the light conductor comprises silica or quartz (e.g. “In the preferred embodiment the core 22 and cladding 24 are fused silica or glass or fluorite glass, so as to withstand high laser power”, Col. 8, ll. 32-34).
In reference to at least claim 9
Kittrell discloses wherein the shield has a first diameter (e.g. optical shield includes multiple lenses 222 having a first diameter) and the light conductor has a second diameter (e.g. optical fibers 20 have a second diameter, Fig. 13E), wherein the second diameter is larger than the first diameter (e.g. optical fibers 20 have a second diameter larger than the lenses, Fig. 13E), wherein the shield is uncoupled from the light conductor (e.g. the multiple lenses 222 are uncoupled from the optical fibers 20, Fig. 13E).
In reference to at least claim 11
Kittrell discloses wherein the damage mitigator comprises an enlarged lens located at a distal end of the light conductor (e.g. Fig. 13A, “The shield may be in the form of a glass, fused silica, sapphire or other transparent member. The shield may be flat, spherical or lens shaped.”, Col. 4, ll. 59-60; “ Lenses or mirrors, and mechanical or optical aiming and focusing devices can be mounted inside of the shield.”, Col. 4, ll. 65-67), the enlarged lens including at least one surface that is non-parallel to a central axis of the light conductor (e.g. Figs. 13A, “The shield may be flat, spherical or lens shaped.”, Col. 4, ll. 59-60), wherein the enlarged lens comprises an enlarged portion of a distal end of the light conductor (e.g. Figs. 13A, “The shield may be flat, spherical or lens shaped.”, Col. 4, ll. 59-60).
In reference to at least claim 12
Kittrell discloses wherein the damage mitigator comprises an enlarged lens located at a distal end of the light conductor (e.g. Fig. 13A, “The shield may be in the form of a glass, fused silica, sapphire or other transparent member. The shield may be flat, spherical or lens shaped.”, Col. 4, ll. 59-60; “ Lenses or mirrors, and mechanical or optical aiming and focusing devices can be mounted inside of the shield.”, Col. 4, ll. 65-67), the enlarged lens including at least one surface that is non-parallel to a central axis of the light conductor (e.g. Figs. 13A, “The shield may be flat, spherical or lens shaped.”, Col. 4, ll. 59-60), wherein the enlarged lens comprises a body having a shape selected from the group comprising a bulbous shape, a triangular shape, a square shape and a trapezoidal shape (e.g. Figs. 13A).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 5,304,173 to Kittrell et al. (Kittrell) in view of US Patent No. 5,323,767 to Lafferty et al. (Lafferty)
In reference to at least claim 2
Kittrell teaches a device according to claim 1. Kittrell further discloses wherein: the light conductor is pinned at a proximal location and at a distal location (e.g. “When multiple optical fibers are used, the overall distribution of light from the laser catheter may be controlled by disposing the fibers at different positions and angles.”, col. 5, ll. 40-43; “Optical fibers 20a,b,b',c,c' are disposed within the catheter body 16 and have a distal termination in the vicinity of the optical shield 12. The corresponding proximal ends 40a,b,b',c,c' of optical fibers 20a,b,b',c,c' are secured by the fiber optic coupler 46. The distal ends of the optical fibers 20a-c' are secured in the material of plug 11. The optical fibers 20a-c' may be angled with respect to the axis of symmetry, as shown in FIG. 1, or they may be straight and coaxial with the distal end of the laser catheter 10, as shown in the longitudinal section FIG. 2. “, Col. 8, ll. 6-16); the shaft spans a first length between the proximal location and the distal location (e.g. the shaft of catheter body 16 has a first length, e.g. Fig. 1); and the light conductor has a second length between the proximal location and the distal location (e.g. optical fibers 20 have a second length between the proximal and distal location, e.g. Fig. 1).
Kittrell discloses the optical fibers 20 having a greater length since they have proximal ends that extends to the optical coupler 46 (Fig. 1) but does not explicitly teach the second length of the optical fibers between the proximal location and the distal location is greater than the first length to produce slack in the light conductor.
Lafferty discloses a portal optics device (e.g. Fig. 1) that includes a transmission fiber 248 that includes a slack loop segment 250 to compensate for movement of transmission fiber bundle 248 (e.g. “transmission fiber 248 includes a slack loop segment 250 to compensate for movement of transmission fiber bundle 248 when scope assembly 204 is rotated relative to camera assembly 202.”, Col. 9, ll. 3-11).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Kittrell to include providing a slack loop within the length of the optical fibers, as taught by Lafferty, resulting in the second length of the optical fibers between the proximal location and the distal location being greater than the first length in order to compensate for any movement of the optical fibers (‘767, Col. 9, ll. 3-11).
Claim(s) 13 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 5,304,173 to Kittrell et al. (Kittrell).
In reference to at least claim 13
Kittrell teaches a device according to claim 1. Kittrell further discloses a light generator coupled to the light conductor, the light generator comprising a laser module (e.g. high power laser 92); and a controller for operating the light generator to produce a laser beam (e.g. computer 80); wherein the controller is configured to generate cleaning laser pulses intermittently with fragmenting laser pulses (e.g. “Short optical pulses can also provide distance (ranging) information. Pulses of accoustical radiation, propagating along an appropriate fiber conduit, can also be used for ranging”, Col. 20, ll. 48-51, the short optical pulses “ remain in operation while the intense laser beam removes tissue, providing real-time diagnostics” Col. 20, ll. 51-55), the cleaning laser pulses being of high power and short duration to remove debris attached to the device (e.g. “Short optical pulses can also provide distance (ranging) information. Pulses of accoustical radiation, propagating along an appropriate fiber conduit, can also be used for ranging”, Col. 20, ll. 48-51).
Kittrell further discloses other embodiments in which the laser catheter is used in combination with a guide catheter (e.g. 140) that includes a channel 142 “working channel” for purge and suction (e.g. “The laser catheter 10 may be used in combination with a guide catheter 140, FIG. 14. The guide catheter 140 is first inserted in the artery 30 of FIG. 4, and brought near the lesion 34. Next, the laser catheter 10 is inserted coaxially within the guide catheter 140 and brought in contact with the lesion 34. A channel 142 (FIG. 14) may be incorporated into the wall of the guide catheter 140. This channel 142 may be used for purge and suction.”, Col. 15, ll. 32-56). Therefore it would have been obvious to modify the laser catheter shown within Figs. 1-2 to be used in combination with a guide catheter that defines a “shaft” that includes a “working channel” extending from the proximal portion to the distal portion in order to provide a channel for purge and suction of the tissue allowing improved visualization.
In reference to at least claim 22
Kittrell discloses a device for performing a surgical procedure (e.g. “A laser catheter is disclosed wherein optical fibers carrying laser light are mounted in a catheter for insertion into an artery to provide controlled delivery of a laser beam for percutaneous intravascular laser treatment of atherosclerotic disease.” abstract), the device comprising: a shaft extending from a proximal portion to a distal portion (e.g. catheter body 16 includes a shaft, Fig. 1); a light conductor extending at least partially through the shaft to be exposed at the distal portion (e.g. optical fibers 20a,b,b’,c,c’, Fig. 1); a damage mitigator positioned to receive light from the light conductor to discharge the light from the device (e.g. optical shield 12 “damage mitigator” receives light from the optical fibers, Fig. 1), wherein the damage mitigator is configured to protect the light conductor from incoming energy comprising at least one of laser energy, thermal energy and kinetic energy (e.g. “The protective optical shield mechanically displaces the blood and also protects the fiber(s) from the intraarterial contents. The fiber(s) are anchored so that there is an appropriate distance between the output end of the fiber(s) and the tip of the shield. The catheter and shield are sealed watertight, preventing blood from coming into contact with the internal components. The intervening space may be filled with fluid, or optical surfaces may be optically contacted, or they may be anti-reflection coated to reduce Fresnel reflections and maximize transmitted light.”, Col. 5, ll. 7-17); a light generator coupled to the light conductor, the light generator comprising a laser module (e.g. high power laser 92); and a controller for operating the light generator to produce a laser beam (e.g. computer 80).
Kittrell further discloses other embodiments in which the laser catheter is used in combination with a guide catheter (e.g. 140) that includes a channel 142 “working channel” for purge and suction (e.g. “The laser catheter 10 may be used in combination with a guide catheter 140, FIG. 14. The guide catheter 140 is first inserted in the artery 30 of FIG. 4, and brought near the lesion 34. Next, the laser catheter 10 is inserted coaxially within the guide catheter 140 and brought in contact with the lesion 34. A channel 142 (FIG. 14) may be incorporated into the wall of the guide catheter 140. This channel 142 may be used for purge and suction.”, Col. 15, ll. 32-56). Therefore it would have been obvious to modify the laser catheter shown within Figs. 1-2 to be used in combination with a guide catheter that defines a “shaft” that includes a “working channel” extending from the proximal portion to the distal portion in order to provide a channel for purge and suction of the tissue allowing improved visualization.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2011/0098528 to Lewinsky which teaches fibers and tips thereof used with device. US 2015/0282695 to Tay et al. which teaches an endoscope with optical fibers.
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