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
Claim 19 objected to because of the following informalities: “a frequency of 308 nm” is not a frequency, but a wavelength (although they are directly proportional). Please correct to a “wavelength of 308nm.”
Claim Rejections - 35 USC § 112(b)
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 1-8 and 15 are 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.
5. Claim 1 recites the limitation "the laser aperture" in line 6. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear if this is the same aperture from line 3 (“laser output aperture.”). For examination purposes, it will be interpreted that the laser output aperture and the laser aperture are different. Claims 2-8 are rejected due to their dependency from claim 1.
6. Claim 9 is rejected for the same reason, and claims 10-15 are rejected due to their dependency from claim 9.
Regarding claims 8 and 15, the term “normally-closed” in relation to the hinged door of claims 8 and 15 is a relative term which renders the claim indefinite. The term “normally-closed” 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. It is unclear if the hinged door is being claimed as only when closed, or if it is can be open. It is recommended by the examiner that the claims are amended to remove the phrase “normally-closed.” For examination purposes, the claim will be interpreted as a hinged door.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 16 and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Cook et al. (US 20210186613 A1, "Cook").
Regarding claim 16, Cook teaches an intravascular therapy method (abstract: "A catheter system for treating a vascular lesion within or adjacent to a vessel wall within a body of a patient includes a catheter fluid, an energy source that generates energy, an energy guide and an energy manifold."), comprising: inserting a catheter assembly (Fig. 1; catheter system 100) comprising a laser catheter (para. [0035]: "In certain embodiments, the catheter systems and related methods utilize an energy source, e.g., a light source such as a laser source or another suitable energy source, which provides energy that is guided by one or more energy guides, e.g., light guides such as optical fibers, which are disposed along the catheter shaft and within the balloon interior of the balloon to create a localized plasma in the catheter fluid that is retained within the balloon interior of the balloon.") surrounded by a containment sheath (Fig. 2; balloon 230, manifold body 260); and further comprising a focusing chamber (Fig. 2; manifold body 260) into a blood vessel to position the focusing chamber at an intravascular treatment site (para. [0036]: "The energy manifold is configured to direct and/or concentrate energy generated within the catheter fluid that is retained within the balloon, and is at least partially retained within the energy manifold, so as to impart pressure onto and induce fractures in the vascular lesion at the treatment site within or adjacent to the blood vessel.") having a calcified occlusion (para. [0046]: "…thus, may be usable for imparting pressure waves onto and inducing fractures in larger vascular lesions"); and after the inserting, treating the calcified occlusion (para. [0046]: "vascular occlusion") by concurrently: inputting laser light into the laser catheter to emit the laser light (para. [0079] mentions laser wavelengths for inducing plasma) at a laser aperture (Fig. 1 and 2; guide distal end 122D of laser guide 122A (shown as 222A and 222D in fig. 2) are output holes for the laser) located inside the focusing chamber (para. [0103]; Fig. 2; one or more manifold apertures); flowing a contrast mixture (para. [0049]; catheter fluid) into the focusing chamber via the containment sheath (para. [0057]: "…the catheter fluid 132 within the balloon interior 146 of the balloon 104 at the distal portion 116.") whereby the laser light induces sonic energy in the contrast mixture in the containment sheath (para. [0058]: "The energy guides 122A can have any suitable design for purposes of generating plasma and/or pressure waves in the catheter fluid 132 within the balloon interior 146."); and by the focusing chamber (manifold 260), directing the sonic energy out a sonic energy aperture (manifold apertures 262) of the focusing chamber (para. [0036]: "More particularly, the energy manifold directs and/or concentrates acoustic and mechanical energy produced by a lithoplasty device, such as a laser-driven pressure wave generating device, to impart pressure onto and induce fractures in the vascular lesion at the treatment site within or adjacent to the blood vessel within the body of the patient.").
Regarding claim 20, Cook teaches the method of claim 16 (see above), wherein the contrast agent comprises iodine. (para. [0053]: "In some embodiments, the contrast agents used in the contrast media can include, but are not to be limited to, iodine-based contrast agents, such as ionic or non-ionic iodine-based contrast agents.").
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.
Claims 1-7 and 9-14 are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20210186613 A1, "Cook") in view of Grace et al. (US 20180008348 A1, “Grace”).
Regarding independent claim 1, Cook teaches an intravascular therapy device (abstract: "A catheter system for treating a vascular lesion within or adjacent to a vessel wall within a body of a patient includes a catheter fluid, an energy source that generates energy, an energy guide and an energy manifold.") comprising: a laser catheter (202) including at least one optical fiber (122A) extending through the laser catheter which terminates at a laser output aperture containment sheath (at the proximal portion of manifold body 260) surrounding the laser catheter (202) and configured to contain a contrast mixture (para. [0049]: " The catheter fluid 132 can be a liquid or a gas. Some examples of the catheter fluid 132 suitable for use can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, or any other suitable catheter fluid 132."); whereby laser light output at the laser output aperture being effective to induce sonic energy in the contrast mixture when the containment sheath covers the laser aperture (para. [0058]: "The energy guides 122A can have any suitable design for purposes of generating plasma and/or pressure waves in the catheter fluid 132 within the balloon interior 146."; para. [0094]: "For example, in some embodiments, the manifold apertures 262 can be round, square, rectangular, triangular, or have other suitable shapes specifically engineered to direct and concentrate the acoustic and/or mechanical energy to specific locations within the balloon 104." the manifold 260 directs energy/waves for treatment based on its configuration); the focusing chamber (manifold 260) including at least one sonic energy aperture (manifold apertures 262) at a side of the focusing chamber, the focusing chamber configured to direct the sonic energy out the at least one sonic energy aperture (para. [0036]: "More particularly, the energy manifold directs and/or concentrates acoustic and mechanical energy produced by a lithoplasty device, such as a laser-driven pressure wave generating device, to impart pressure onto and induce fractures in the vascular lesion at the treatment site within or adjacent to the blood vessel within the body of the patient."). However, Cook does not expressly teach the containment sheath being longitudinally movable respective to the laser catheter, and a focusing chamber arranged over the containment sheath.
Grace, in the same field of endeavor of treating vasculature with catheter-based devices, discloses a device for laser-induced treatment. Grace discloses a containment sheath being longitudinally movable respective to the laser catheter (para. [0381]: " The axial locations of the laser catheter 1010 and the sheath 1120 may be adjusted by translating either or both components with respect to one another.") to cover or uncover the laser aperture (para. [0382] discloses where only a portion of the vascular occlusion depending on how much of the sheath is translated); and a focusing chamber (Fig. 11A-D; sheath 1140 (different than sheath 1120)) arranged over the containment sheath (Fig. 11A-D; sheath 1120; para. [0441]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cook to further include the movable sheath to cover and uncover the aperture, as well as the chamber of the containment sheath, as disclosed by Grace. In doing so, there would be improved means of controlling the delivery of laser-induced waves to treat occluded vasculature. Further, better control of the laser would allow for precise control over treatment waves produced by the laser. Therefore, it would have been obvious to include the longitudinally adjustable feature and sheath, as disclosed by Grace, to enhance the precision and control in the device of Cook.
Regarding independent claim 9, Cook teaches an intravascular therapy device (abstract: "A catheter system for treating a vascular lesion within or adjacent to a vessel wall within a body of a patient includes a catheter fluid, an energy source that generates energy, an energy guide and an energy manifold.") comprising: a laser catheter (202) including at least one optical fiber (122A) extending through the laser catheter which terminates at a laser output aperture containment sheath (at the proximal portion of manifold body 260) surrounding the laser catheter (202) and configured to contain a contrast mixture (para. [0049]: " The catheter fluid 132 can be a liquid or a gas. Some examples of the catheter fluid 132 suitable for use can include, but are not limited to one or more of water, saline, contrast medium, fluorocarbons, perfluorocarbons, gases, such as carbon dioxide, or any other suitable catheter fluid 132."); whereby laser light output at the laser output aperture being effective to induce sonic energy in the contrast mixture when the containment sheath covers the laser aperture (para. [0058]: "The energy guides 122A can have any suitable design for purposes of generating plasma and/or pressure waves in the catheter fluid 132 within the balloon interior 146."; para. [0094]: "For example, in some embodiments, the manifold apertures 262 can be round, square, rectangular, triangular, or have other suitable shapes specifically engineered to direct and concentrate the acoustic and/or mechanical energy to specific locations within the balloon 104." the manifold 260 directs energy/waves for treatment based on its configuration); a focusing chamber (manifold 260) including at least one sonic energy aperture (manifold apertures 262) at a side of the focusing chamber, the focusing chamber configured to direct the sonic energy out the at least one sonic energy aperture (para. [0036]: "More particularly, the energy manifold directs and/or concentrates acoustic and mechanical energy produced by a lithoplasty device, such as a laser-driven pressure wave generating device, to impart pressure onto and induce fractures in the vascular lesion at the treatment site within or adjacent to the blood vessel within the body of the patient."). However, Cook does not expressly teach the containment sheath being longitudinally movable respective to the laser catheter; a focusing chamber arranged over the containment sheath; and wherein the focusing chamber is configured to move longitudinally along a length of the laser catheter to longitudinally align the at least one sonic energy aperture with the laser output aperture.
Grace, in the same field of endeavor of treating vasculature with catheter-based devices, discloses a device for laser-induced treatment. Grace discloses a containment sheath being longitudinally movable respective to the laser catheter (para. [0381]: " The axial locations of the laser catheter 1010 and the sheath 1120 may be adjusted by translating either or both components with respect to one another.") to cover or uncover the laser aperture (para. [0382] discloses where only a portion of the vascular occlusion depending on how much of the sheath is translated); and a focusing chamber (Fig. 11A-D; sheath 1140 (different than sheath 1120)) arranged over the containment sheath (Fig. 11A-D; sheath 1120; para. [0441]); and wherein the focusing chamber (Fig. 11A-D; sheath 1140 (different than sheath 1120) is configured to move longitudinally (para. [0381]: " The axial locations of the laser catheter 1010 and the sheath 1120 may be adjusted by translating either or both components with respect to one another."; laser catheter 1010) along a length of the laser catheter to longitudinally align the at least one sonic energy aperture with the laser output aperture (para. [0392] describes rotating the drive mechanism to align the opening 1454 with the proximal passageway 1438: "an opening 1454 extending therebetween and aligned with the proximal passageway 1438."; Fig. 16A).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Cook to further include the movable sheath to cover and uncover the aperture, as well as the chamber of the containment sheath, as disclosed by Grace. In doing so, there would be improved means of controlling the delivery of laser-induced waves to treat occluded vasculature. Further, better control of the laser would allow for precise control over treatment waves produced by the laser. Therefore, it would have been obvious to include the longitudinally adjustable feature and sheath, as disclosed by Grace, to enhance the precision and control in the device of Cook.
Regarding claims 2 and 10, Cook, in combination with Grace, discloses the device of claim 1 and the device of claim 9 (see rejections of claims 1 and 9 above). Cook further discloses wherein the at least one sonic energy aperture of the focusing chamber includes at least one opening or at least one sonic energy-transmissive window. (para. [0060]: "Each energy guide 122A can guide energy along its length from a guide proximal end 122P to the guide distal end 122D having at least one optical window (not shown) that is positioned within the balloon interior 146.")
Regarding claims 3 and 11, Cook, in combination with Grace, discloses the device of claim 1 and the device of claim 9 (see rejections of claims 1 and 9 above). Grace discloses wherein the focusing chamber comprises a stainless steel tube. (para. [0358]: " One example of such an outer sheath 182 includes a slotted or laser-cut hypotube constructed of a biocompatible material, such as stainless steel, or a biocompatible polymer. The hypotube has spring-like characteristics, which allow it to expand and contract in a longitudinal direction. Specifically, the slotted or laser cut pattern in the hypotube allows it to expand and contract.").
Regarding claims 4 and 12, Cook, in combination with Grace, discloses the device of claim 1 and the device of claim 9 (see rejections of claims 1 and 9 above). Cook further discloses wherein the focusing chamber (Fig. 2; guide 222A and jacket 264A) is attached to an outside of the containment sheath (Proximal end of 260 (260P); the guide 222A and jacket 264A are attached to the outside of 260P).
Regarding claims 5 and 13, Cook, in combination with Grace, discloses the device of claim 1 and the device of claim 9 (see rejections of claims 1 and 9 above). Grace discloses an additional sheath surrounding the containment sheath, the focusing chamber attached to the additional sheath. (para. [0391]: " the base 1426 includes an elongated, hollow frame 1430 that movably couples to the drive mechanism 1428. The frame 1430 includes a proximal portion 1432, an intermediate portion 1434, and a distal portion 1436."; The frame 1430 surrounds the sheaths and are considered to be an additional layer. Further, 1428 can be considered to be an additional layer that surrounds the sheath.).
Regarding claims 6 and 14, Cook, in combination with Grace, discloses the device of claim 1 and the device of claim 9 (see rejections of claims 1 and 9 above). Grace discloses a control disposed at a proximal end of the device and configured to rotate the focusing chamber around the laser catheter. (Para. [0051]: "A handle according to any of paragraphs [0009]-[0050], wherein the control element includes a first threaded surface, and the drive mechanism further includes a shaft that is translatable within the base and coupled to the coupling, the shaft including a second threaded surface, and the second threaded surface coupling to the first threaded surface such that rotation of the control element relative to the base causes translation of the shaft within the base and translation of the laser catheter within the lumen of the sheath."; para. [0398] describes rotation of the shaft's first threaded surface around the second threaded surface of the catheter, which causes translation).
Regarding claims 7, Cook, in combination with Grace, discloses the device of claim 1 (see rejections of claim 1 above). Grace discloses a focusing chamber is configured to move longitudinally along a length of the laser catheter to longitudinally align the at least one sonic energy aperture (1454 Fig. 16A) with the laser output aperture (1438 16A). (Fig. 16A; para. [0392]: " an opening 1454 extending therebetween and aligned with the proximal passageway 1438."; the opening 1454 is adjusted with the control to align with the passageway. This is done with the drive mechanism and control, which translates the shaft longitudinally).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20210186613 A1, "Cook"), Grace et al. (US 20180008348 A1, “Grace”), and Bowe (US 20150342682 A1).
Regarding claims 8 and 15, Cook, in combination with Grace, discloses the device of claim 1 and the device of claim 9 (see rejections of claims 1 and 9 above). However, neither reference discloses a hinged-door.
Bowe, concerned with the same problem of restoring blood flow to an occluded vessel, discloses a system and method for ablation and removal of occlusions using a laser catheter device. Bowe discloses wherein the focusing chamber (inner lumen 14) includes a normally-closed 112b hinged door (gate 1204) at a distal end of the focusing chamber (para. [0111]: "For example, other means for covering the opening, such as a hinged gate within the opening 1204 may also be used."; The end of 12b with the gate could be considered to be the distal end since the catheter is being inserted into the vessel).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to include the gate of Bowe in the focusing chamber of Grace (which, as detailed in the rejection of claim 1, would have been obvious to include in a modification to Cook). In doing so, the device would be able to improve control over laser removal parameters during occlusion treatment procedures. This would improve efficiency for occlusion removal without undesired consequences. Further, a hinge-door is disclosed as being an effective tool for opening and covering an aperture, as shown in Cook. It would have been obvious to use this same tool for opening and closing an aperture in the device chamber of Grace to effectively control the focus of the laser. Therefore, it would have been an obvious improvement to the device of Grace to include a hinged-door for opening and covering the aperture.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20210186613 A1, "Cook") in view of Brown et al. (US 20180303548 A1, “Brown”).
Regarding claim 17, Cook teaches the method of claim 16 (see above). However, Cook does not expressly teach the step of aligning the laser aperture located inside the focusing chamber with a laser output aperture of the laser catheter to direct the sonic energy.
Brown, in the same field of endeavor of catheter-based laser surgery devices, discloses a side-firing laser system. Brown discloses aligning the laser aperture located inside the focusing chamber with a laser output aperture. (para. [0044]: "…when water or saline solution is used and the laser beam 30 is aligned with the aperture or opening 105, any liquid in the opening 105 or present in the direct path of the treatment radiation beam between the catheter and the tissue…"; The laser is focused to align with the opening 105. Although it is not disclosed to be direction of sonic energy, the radiation treatment is directed through the opening the same as a sonic energy would be).
It would have been obvious for one of ordinary skill in the art to modify the method of Cook to further include the step of aligning the laser focus and output aperture, as disclosed by Brown. One of ordinary skill would have recognized that it would have been obvious to include alignment of apertures for treatment output. In doing so, the method of Cook would improve control as to include the side-firing laser treatment, as disclosed by Brown. One of ordinary skill would recognize the need for alignment of apertures to perform laser-firing from the side of a catheter. This would have been an obvious improvement to include in the device of Cook since it would enhance the laser output to include side-directions. Further, it would have been simple substitution to include shockwaves or sonic waves, as disclosed by Cook, as the output from the aperture depending on the treatment required. One of ordinary skill would recognize the predictability of directing shock-waves out of an aperture as opposed to radiation, and that both could be directed successfully.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20210186613 A1, "Cook") in view of Tschida et al. (US 20200046429 A1, “Tschida”).
Regarding claim 18, Cook teaches the method of claim 16 (see above). However, Cook does not expressly teach the step of rotating the focusing chamber around the laser catheter to direct the sonic energy.
Tschida, in the same field of endeavor of laser catheters for treating vascular occlusions, discloses a device for laser-induced pressure waves created within a sheath. Tschida discloses rotating the focusing chamber (deflect 792) around the laser catheter (750) to direct the sonic energy. (para. [0369]: “the laser catheter 750 may include a deflector 792 disposed distally from the one or more optical fibers 786 of the laser catheter 750, may be configured to direct the laser-induced pressure waves in a radial direction… The present disclosure also contemplates that the laser catheter 750 may rotate within the sheath 782 about the longitudinal axis of the laser catheter 750 and/or sheath 782…”.).
It would have been obvious for one of ordinary skill in the art to modify the method of Cook to further include the step of rotating the chamber around the laser catheter to direct the energy, as disclosed by Tschida. One of ordinary skill would recognize that rotating a mechanism to deliver treatment waves would improve the method of Cook by further enhancing the direction of the treatment, as disclosed by Tschida (see para. [0369], which talks about how the rotation allows for delivery in not only longitudinal, but radial directions as well). One of ordinary skill would recognize that inclusion of this rotation step would improve the delivery of treatment to include radial and longitudinal directions, and that, as Tschida demonstrates, would reasonably be expected to accomplish multi-directional output. Therefore, it would have been obvious to include this method step to improve the method of Cook.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Cook et al. (US 20210186613 A1, "Cook") in view of Lukac et al. (US 20210069756 A1, “Lukac”).
Regarding claim 19, Cook teaches the method of claim 16 (see above). However, Cook does not expressly teach wherein the laser light has a frequency of 308 nm.
Lukac, solving the common problem of removing occlusion from vessels using laser-induced waves, discloses a method of treatment for clearing a vessel. Lukac discloses wherein the laser light has a frequency of 308 nm. (para. [0122]: "[0122] Other examples of laser sources 4,4′ with a laser wavelength highly absorbed in water and other liquids include quadrupled Nd:YAG laser which generates light having a wavelength of 266 nm; an ArF excimer laser which generates light having a wavelength of 193 nm, an XeCl excimer laser which generates light having a wavelength of 308 nm.").
It would have been obvious for one of ordinary skill in the art to modify the method of Cook to further include a laser pulse with a wavelength of 308nm. One of ordinary skill would have recognized that the lasers at this wavelength would be effective to create shock waves for treating an occluded vessel, as disclosed by Lukac. One of ordinary skill would recognize that including this wavelength would produce the desired result of breaking down an occlusion. Therefore, it would be desirable and obvious to include the wavelength of Lukac in the method of Cook.
Conclusion
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/O.L.M./
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796
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