DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/13/2026 has been entered.
Remarks
This action is in response to the amendments filed 04/13/2026.
Claims 1-17, 37, 38, 40, 45, 50, and 55-63 are pending.
Response to Arguments
Applicant’s arguments, see page 8, filed 04/13/2026, with respect to the objection of claim 10 have been fully considered and are persuasive. The objection of claim 10 has been withdrawn.
Applicant's arguments, see pages 8-16, filed 04/13/2026, regarding the rejection of claims 1-17, 37, 38, 40, 45, 50, and 55-58 under 35 U.S.C. 103 have been fully considered and are persuasive. Independent claims 1 and 37 have been amended to include “the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber”. New claims 59-63 have been added. Applicant argues that Grace or Grace in view of Beyar do not disclose or suggest the amended claim limitations. Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made, as explained in the office action below. New claims 59-63 are addressed in the office action below.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-8, 11-14, 59-61, and 63 are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack.
Regarding claim 1, Grace discloses an apparatus configured to fracture coronary calcium (e.g. Abstract), the apparatus comprising:
an expandable member (e.g. Par. [0286]: expanding balloon; Fig. 1, 2: expanded balloon 150);
a laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230); and
an optical fiber coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers), wherein:
the expandable member is an intravascular balloon configured for radial expansion (e.g. Par. [0286]: expanding balloon; Fig. 1, 2: expanded balloon 150);
the expandable member and the optical fiber are coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230);
the optical fiber comprises multiple emission regions configured to emit electromagnetic energy from the laser light source from the optical fiber (e.g. Par. [0273]: optical fibers terminate at different points of emission, which are considered to be the emission regions, “The one or more layers of optical fibers are housed in a flexible tubular catheter and terminate at different points of emission (such as, emitters), where the laser light energy is released and directed towards a desired target.”);
emission of electromagnetic energy from the multiple emission regions are configured to create fractures in the coronary calcium (e.g. Par. [0387]: disrupting calcification; Par. [0390]: energy is used to disrupt vascular obstructions such as coronary calcium, “The catheter of the present disclosure is able to create laser-induced pressure waves, which fracture or disrupt the calcium deposits 2370 in the media 2330 of the arterial wall 2300″ as shown in FIG. 23C”);
the laser light source is configured to emit electromagnetic energy at a wavelength between 700 nanometers (nm) and 850 nm (e.g. Par. [0292]: wavelength can be 250-750nm which includes wavelengths in the claimed range); and
the expandable member contains a fluid (e.g. Par. [0273]: liquid medium inflates balloon).
However, Grace fails to disclose wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber and wherein the fluid comprises indocyanine green (ICG) and . Beyar is directed towards a delivery system. Beyar discloses wherein the fluid comprises indocyanine green (ICG) in order to increase energy absorption (e.g. Par. [0220]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid of Grace to be indocyanine green (ICG) as taught by Beyar, because doing so would increase energy absorption (e.g. Beyar, par. [0220]).
However, Grace in view of Beyar fails to disclose wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber.
Harschack is directed towards a laser ablation device. Harschack discloses an optical fiber with conical emission regions configured such that the emission regions emit electromagnetic energy in a radial pattern from the optical fiber (e.g. Par. [0038]: two radiation zones shaped as a cone).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar to include an optical fiber with conical emission regions as taught by Harschack, because doing so would provide a laser treatment that enhances the speed of removal, ease of handling, and effective vessel ablation (e.g. Harschack, par. [0017]).
Regarding claim 3, Grace fails to disclose wherein the one or more reliefs are configured as conical reliefs in the optical fiber. Harschack is directed towards a laser ablation device. Harschack discloses an optical fiber with conical emission regions (e.g. Par. [0038]: two radiation zones shaped as a cone).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar to include an optical fiber with conical emission regions as taught by Harschack, because doing so would provide a laser treatment that enhances the speed of removal, ease of handling, and effective vessel ablation (e.g. Harschack, par. [0017]).
Regarding claim 4, Grace further discloses wherein: the optical fiber is a first optical fiber, the apparatus further comprises a plurality of optical fibers, and each optical fiber of the plurality of optical fibers comprises multiple emission regions configured to emit electromagnetic energy in a radial pattern from each optical fiber (e.g. Par. [0280]: one or more optical fibers coupled to a laser; Par. [0334]: light is emitted in a radial pattern).
Regarding claim 5, Grace further discloses wherein the expandable member is a balloon (e.g. Par. [0286]: expanding balloon; Fig. 1, 2: expanded balloon 150).
Regarding claim 6, Grace further discloses wherein the expandable member is configured to be expanded via a fluid contained within the expandable member (e.g. Par. [0273]: liquid medium inflates balloon).
Regarding claim 7, Grace further discloses a first port configured to deliver the fluid to the expandable member (e.g. Par. [0275]: liquid medium is delivered to the balloon “the liquid medium 160 is delivered into the balloon 150 via one or more liquid medium ports 170”).
Regarding claim 8, Grace further discloses a second port configured to drain the fluid from the expandable member (e.g. Par. [0276]: “Liquid medium 160 can be removed from the balloon 150 through a separate set of liquid medium ports that act as liquid medium exit ports”).
Regarding claim 11, Grace further discloses wherein the fluid is a saline fluid (e.g. Par. [0091]: the liquid medium can be saline).
Regarding claim 12, Grace further discloses wherein the optical fiber is configured to emit the electromagnetic energy in a radial pattern (e.g. Par. [0334]: light is emitted in a radial pattern).
Regarding claim 13, Grace further discloses wherein the electromagnetic energy is emitted at a wavelength of approximately 2 µm (e.g. Par. [0021]: light emitted from 1nm – 1mm, which is between 0.001 µm – 1000 µm).
Regarding claim 14, Grace further discloses wherein the electromagnetic energy is emitted at a wavelength between 1.5 µm and 2.5 µm (e.g. Par. [0021]: light emitted from 1nm – 1mm, which is between 0.001 µm – 1000 µm).
Regarding claim 59, Grace fails to disclose wherein the one or more reliefs are configured as angled reliefs in the optical fiber. Harschack is directed towards a laser ablation device. Harschack discloses an optical fiber with angled reliefs (e.g. Par. [0038]: two radiation zones shaped as a cone).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include an optical fiber with angled reliefs as taught by Harschack, because doing so would provide a laser treatment that enhances the speed of removal, ease of handling, and effective vessel ablation (e.g. Harschack, par. [0017]).
Regarding claim 60, Grace in view of Beyar and Harschack further discloses one or more reliefs in the optical fiber (e.g. Harschack, Par. [0038]: two radiation zones shaped as a cone). Grace in view of Beyar and Harschack discloses the claimed invention but does not disclose expressly the reliefs being configured as flat reliefs. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the invention as taught by Grace in view of Beyar and Harschack with the reliefs being configured as flat reliefs, because Applicant has not disclosed that the reliefs being configured as flat reliefs provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the reliefs as taught by Grace in view of Beyar and Harschack, because it provides the predictable results of emitting the light and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Grace in view of Beyar and Harschack. Therefore, it would have been an obvious matter of design choice to modify Grace in view of Beyar and Harschack to obtain the invention as specified in the claim.
Regarding claim 61, Grace in view of Beyar and Harschack further discloses one or more reliefs in the optical fiber (e.g. Harschack, Par. [0038]: two radiation zones shaped as a cone). Grace in view of Beyar and Harschack discloses the claimed invention but does not disclose expressly the reliefs being configured as beveled reliefs in the optical fiber. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the invention as taught by Grace in view of Beyar and Harschack with the reliefs being configured as beveled reliefs, because Applicant has not disclosed that the reliefs being configured as beveled reliefs provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the reliefs as taught by Grace in view of Beyar and Harschack, because it provides the predictable results of emitting the light and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Grace in view of Beyar and Harschack. Therefore, it would have been an obvious matter of design choice to modify Grace in view of Beyar and Harschack to obtain the invention as specified in the claim.
Regarding claim 63, Grace fails to disclose wherein the one or more reliefs are the regions not at the distal end of the optical fiber. Harschack is directed towards a laser ablation device. Harschack discloses wherein the one or more reliefs are the regions not at the distal end of the optical fiber (e.g. Par. [0038]: two radiation zones shaped as a cone; Fig. 1: emission zones 102 and 106 not at the end of the optical fiber).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include the reliefs being the regions not at the distal end of the optical fiber as taught by Harschack, because doing so would provide a laser treatment that enhances the speed of removal, ease of handling, and effective vessel ablation (e.g. Harschack, par. [0017]).
Claims 1 and 2 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al. (US Patent Application Publication 2018/0304053 – of record), hereinafter Eggert, further in view of Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record).
Regarding claim 1, Eggert discloses apparatus configured to fracture coronary calcium (e.g. Abstract), the apparatus comprising: an expandable member (e.g. Par. [0042]: balloon 18); wherein: the expandable member is an intravascular balloon configured for radial expansion (e.g. Par. [0042]); emission regions configured to emit the energy (e.g. Par. [0050]; Fig. 7); wherein emission of energy from the emission regions to create fractures in the coronary calcium (e.g. Par. [0050]); wherein the expandable member contains a fluid (e.g. Par. [0049]).
However, Eggert fails to disclose a laser light source, an optical fiber coupled to the laser light source, wherein the expandable member and the optical fiber are coupled to the laser light source, the optical fiber comprises multiple emission regions configured to emit electromagnetic energy from the laser light source from the optical fiber, the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber, the laser light source is configured to emit electromagnetic energy at a wavelength between 700 nanometers (nm) and 850 nm, and the fluid comprises indocyanine green (ICG).
Grace, in a similar field of endeavor, is directed towards a catheter for disrupting vascular occlusions. Grace discloses a laser light source, an optical fiber coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230), wherein the expandable member and the optical fiber are coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230), the optical fiber comprises multiple emission regions configured to emit electromagnetic energy from the laser light source from the optical fiber (e.g. Par. [0387]: disrupting calcification; Par. [0390]: energy is used to disrupt vascular obstructions such as coronary calcium, “The catheter of the present disclosure is able to create laser-induced pressure waves, which fracture or disrupt the calcium deposits 2370 in the media 2330 of the arterial wall 2300″ as shown in FIG. 23C”), and the laser light source is configured to emit electromagnetic energy at a wavelength between 700 nanometers (nm) and 850 nm (e.g. Par. [0292]: wavelength can be 250-750nm which includes wavelengths in the claimed range).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Eggert to include the laser light source and optical fiber coupled to the light source as taught by Grace, because doing so would provide treatment without heating, tissue tears, and cavitation (e.g. Grace, par. [0285]).
However, Eggert in view of Grace fails to disclose wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber and wherein the fluid comprises indocyanine green (ICG). Beyar is directed towards a delivery system. Beyar discloses wherein the fluid comprises indocyanine green (ICG) in order to increase energy absorption (e.g. Par. [0220]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid of Eggert in view of Grace to be indocyanine green (ICG) as taught by Beyar, because doing so would increase energy absorption (e.g. Beyar, par. [0220]).
However, Eggert in view of Grace and Beyar fails to disclose wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber.
Harschack is directed towards a laser ablation device. Harschack discloses an optical fiber with conical emission regions configured such that the emission regions emit electromagnetic energy in a radial pattern from the optical fiber (e.g. Par. [0038]: two radiation zones shaped as a cone).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Eggert in view of Grace and Beyar to include an optical fiber with conical emission regions as taught by Harschack, because doing so would provide a laser treatment that enhances the speed of removal, ease of handling, and effective vessel ablation (e.g. Harschack, par. [0017]).
Regarding claim 2, Eggert further discloses wherein: the expandable member comprises a fluid (e.g. Par. [0049]); and the emission of electromagnetic energy from the emission regions is configured to create fractures in the coronary calcium by generating ultrasonic waves in the fluid (e.g. Par. [0050]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack, as applied to claim 7 above, and further in view of Schultheis et al. (US Patent Application Publication 2021/0267685 – of record), hereinafter Schultheis.
Regarding claim 9, Grace fails to specifically disclose wherein the second port is further configured to evacuate vapor bubbles from the expandable member. Schultheis is directed towards a fluid recirculation device for an intravascular device. Schultheis discloses a second port further configured to evacuate vapor bubbles from the expandable member (e.g. Par. [0028]: the fluid recirculation system can be used to remove the bubbles; Par. [0068]: the fluid circulator is connected to the fluid outflow port).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include a second port further configured to evacuate vapor bubbles from the expandable member as taught by Schultheis, because doing so would remove any unwanted bubbled from the fluid.
Claims 10, 56, 57, and 62 are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack, as applied to claim 6 above, and further in view of Cook et al. (US Patent Application Publication 2021/0186613), hereinafter Cook.
Regarding claims 10 and 57, Grace further discloses the fluid contained in the expandable member absorbs radiation emitted by the laser light source (e.g. Par. [0274]: the liquid medium is configured to absorb the light energy and generate pressure waves). However, Grace fails to specifically disclose the fluid contained in the expandable member has a concentration that is tuned such that the wavelength corresponding to the maximum absorption coefficient for the fluid contained in the expandable member is approximately equal to the wavelength of the electromagnetic energy emitted from the laser light source. Cook, in a similar field of endeavor, is directed towards a catheter system for treating vascular lesions. Cook discloses the fluid having an absorptive agent having a concentration that is tuned such that the wavelength corresponding to the maximum absorption coefficient for the fluid contained in the expandable member is approximately equal to the wavelength of the electromagnetic energy emitted from the laser light source (e.g. Par. [0071]: the agent can have an absorption maximum matched to the emission maximum of the laser).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include the fluid containing an absorption matching the maximum absorption of the laser as taught by Cook, because doing so would result in the liquid medium absorbing all of the laser/light energy.
Regarding claim 56, Grace fails to disclose wherein a wavelength corresponding to the maximum absorption coefficient for the fluid contained in the expandable member is approximately equal to the wavelength of the electromagnetic energy emitted from the laser light source. Cook, in a similar field of endeavor, is directed towards a catheter system for treating vascular lesions. Cook discloses the fluid having an absorptive agent having a concentration that is tuned such that the wavelength corresponding to the maximum absorption coefficient for the fluid contained in the expandable member is approximately equal to the wavelength of the electromagnetic energy emitted from the laser light source (e.g. Par. [0071]: the agent can have an absorption maximum matched to the emission maximum of the laser).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include the fluid containing an absorption matching the maximum absorption of the laser as taught by Cook, because doing so would result in the liquid medium absorbing all of the laser/light energy.
Regarding claim 62, Grace fails to disclose wherein at least one of the multiple emission points comprise a gradient-index lens coupled to distal end of the optical fiber. Cook, in a similar field of endeavor, is directed towards a catheter system for treating vascular lesions. Cook discloses a gradient-index lens coupled to distal end of the optical fiber (e.g. Par. [0083]: diverting light feature can be a gradient-index lens). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include the gradient-index lens coupled to distal end of the optical fiber as taught by Cook, because a gradient-index lens is a known feature that can be used for diverting light (e.g. Cook, par. [0083]).
Claims 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack, as applied to claim 1 above, and further in view of Takahashi et al. (US Patent Application Publication 2020/0093543 – of record), hereinafter Takahashi.
Regarding claim 15, Grace fails to disclose an intravascular imaging device. Takahashi is directed towards a route selection assistance system. Takahashi discloses an intravascular imaging device (e.g. Par. [0151]: the imaging can be through IVUS or OCT).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include the imaging device as taught by Takahashi, because doing so would result in obtaining intravascular images for diagnosis or for providing guidance to the catheter.
Regarding claim 16, Grace fails to disclose wherein the intravascular imaging device is an intravascular ultrasound (IVUS) device. Takahashi is directed towards a route selection assistance system. Takahashi discloses an intravascular imaging device, wherein the intravascular imaging device is an intravascular ultrasound (IVUS) device (e.g. Par. [0151]: the imaging can be through IVUS or OCT).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar, Harschack, and Takahashi to include the imaging device being an IVUS device as taught by Takahashi, because doing so would result in obtaining intravascular images for diagnosis or for providing guidance to the catheter.
Regarding claim 17, Grace fails to disclose an intravascular imaging device, wherein the intravascular imaging device is an optical coherence tomography imagine (OCT) device. Takahashi is directed towards a route selection assistance system. Takahashi discloses an intravascular imaging device, wherein the intravascular imaging device is an optical coherence tomography imagine (OCT) device (e.g. Par. [0151]: the imaging can be through IVUS or OCT).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar, Harschack, and Takahashi to include the imaging device being an OCT device as taught by Takahashi, because doing so would result in obtaining intravascular images for diagnosis or for providing guidance to the catheter.
Claims 37 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Takahashi et al. (US Patent Application Publication 2020/0093543 – of record), hereinafter Takahashi, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack.
Regarding claim 37, Grace discloses an apparatus configured to fracture coronary calcium (e.g. Abstract), the apparatus comprising:
an expandable member (e.g. Par. [0286]: expanding balloon; Fig. 1, 2: expanded balloon 150);
a laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230); and
an optical fiber coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers), wherein:
the expandable member is an intravascular balloon configured for radial expansion (e.g. Par. [0286]: expanding balloon; Fig. 1, 2: expanded balloon 150);
the expandable member and the optical fiber are coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230);
the optical fiber comprises a proximal end and a distal end (e.g. Par. [0280]: optical fibers extending from a proximal to a distal end, wherein the proximal end is connected to a laser source and the distal end transmits the energy);
the optical fiber is configured to emit electromagnetic energy from the laser light source from the distal end of the optical fiber (e.g. Par. [0280]: optical fibers extending from a proximal to a distal end, wherein the proximal end is connected to a laser source and the distal end transmits the energy);
the laser light source is configured to emit electromagnetic energy at a wavelength between 700 nanometers (nm) and 850 nm (e.g. Par. [0292]: wavelength can be 250-750nm which includes wavelengths in the claimed range);
the optical fiber comprises multiple emission regions configured to emit electromagnetic energy from the laser light source from the optical fiber (e.g. Par. [0273]: optical fibers terminate at different points of emission, which are considered to be the emission regions, “The one or more layers of optical fibers are housed in a flexible tubular catheter and terminate at different points of emission (such as, emitters), where the laser light energy is released and directed towards a desired target.”); and
the expandable member contains a fluid (e.g. Par. [0273]: liquid medium inflates balloon).
However, Grace fails to disclose an intravascular imaging device and wherein the fluid comprises indocyanine green (ICG) and wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber.
Takahashi is directed towards a route selection assistance system. Takahashi discloses an intravascular imaging device (e.g. Par. [0151]: the imaging can be through IVUS or OCT).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace to include the imaging device as taught by Takahashi, because doing so would result in obtaining intravascular images for diagnosis or for providing guidance to the catheter.
However, Grace in view of Takahashi fails to disclose wherein the fluid comprises indocyanine green (ICG) and wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber. Beyar is directed towards a delivery system. Beyar discloses wherein the fluid comprises indocyanine green (ICG) in order to increase energy absorption (e.g. Par. [0220]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid of Grace in view of Takahashi to be indocyanine green (ICG) as taught by Beyar, because doing so would increase energy absorption (e.g. Beyar, par. [0220]).
However, Grace in view of Beyar fails to disclose wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber.
Harschack is directed towards a laser ablation device. Harschack discloses an optical fiber with conical emission regions configured such that the emission regions emit electromagnetic energy in a radial pattern from the optical fiber (e.g. Par. [0038]: two radiation zones shaped as a cone).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Takahashi and Beyar to include an optical fiber with conical emission regions as taught by Harschack, because doing so would provide a laser treatment that enhances the speed of removal, ease of handling, and effective vessel ablation (e.g. Harschack, par. [0017]).
Regarding claim 40, Grace further discloses wherein the expandable member is configured to be expanded via a fluid contained within the expandable member (e.g. Par. [0273]: liquid medium inflates balloon).
Claim 37 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Eggert et al. (US Patent Application Publication 2018/0304053 – of record), hereinafter Eggert, further in view of Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Takahashi et al. (US Patent Application Publication 2020/0093543 – of record), hereinafter Takahashi, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack.
Regarding claim 37, Eggert discloses apparatus configured to fracture coronary calcium (e.g. Abstract), the apparatus comprising: an expandable member (e.g. Par. [0042]: balloon 18); wherein: the expandable member is an intravascular balloon configured for radial expansion (e.g. Par. [0042]); emission regions configured to emit the energy (e.g. Par. [0050]; Fig. 7); wherein emission of energy from the emission regions to create fractures in the coronary calcium (e.g. Par. [0050]); wherein the expandable member contains a fluid (e.g. Par. [0049]).
However, Eggert fails to disclose an intravascular imaging device, a laser light source, an optical fiber coupled to the laser light source, wherein the expandable member and the optical fiber are coupled to the laser light source, the optical fiber comprises a proximal end and a distal end, the optical fiber is configured to emit electromagnetic energy from the laser light source from the distal end of the optical fiber, the optical fiber comprises multiple emission regions configured to emit electromagnetic energy from the laser light source from the optical fiber, the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber, the laser light source is configured to emit electromagnetic energy at a wavelength between 700 nanometers (nm) and 850 nm, and the fluid comprises indocyanine green (ICG).
Grace, in a similar field of endeavor, is directed towards a catheter for disrupting vascular occlusions. Grace discloses a laser light source, an optical fiber coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230), wherein the expandable member and the optical fiber are coupled to the laser light source (e.g. Par. [0280]: a laser coupled to optical fibers; Fig. 2: laser apparatus 230), the optical fiber comprises a proximal end and a distal end, the optical fiber is configured to emit electromagnetic energy from the laser light source from the distal end of the optical fiber (Par. [0280]: optical fibers extending from a proximal to a distal end, wherein the proximal end is connected to a laser source and the distal end transmits the energy), the optical fiber comprises multiple emission regions configured to emit electromagnetic energy from the laser light source from the optical fiber (e.g. Par. [0387]: disrupting calcification; Par. [0390]: energy is used to disrupt vascular obstructions such as coronary calcium, “The catheter of the present disclosure is able to create laser-induced pressure waves, which fracture or disrupt the calcium deposits 2370 in the media 2330 of the arterial wall 2300″ as shown in FIG. 23C”), and the laser light source is configured to emit electromagnetic energy at a wavelength between 700 nanometers (nm) and 850 nm (e.g. Par. [0292]: wavelength can be 250-750nm which includes wavelengths in the claimed range).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Eggert to include the laser light source and optical fiber coupled to the light source as taught by Grace, because doing so would provide treatment without heating, tissue tears, and cavitation (e.g. Grace, par. [0285]).
However, Eggert in view of Grace fails to disclose an intravascular imaging device, wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber and wherein the fluid comprises indocyanine green (ICG).
Takahashi is directed towards a route selection assistance system. Takahashi discloses an intravascular imaging device (e.g. Par. [0151]: the imaging can be through IVUS or OCT).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Eggert in view of Grace to include the imaging device as taught by Takahashi, because doing so would result in obtaining intravascular images for diagnosis or for providing guidance to the catheter.
However, Eggert in view of Grace and Takahashi fails to disclose wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber and wherein the fluid comprises indocyanine green (ICG).
Beyar is directed towards a delivery system. Beyar discloses wherein the fluid comprises indocyanine green (ICG) in order to increase energy absorption (e.g. Par. [0220]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the fluid of Eggert in view of Grace and Takahashi to be indocyanine green (ICG) as taught by Beyar, because doing so would increase energy absorption (e.g. Beyar, par. [0220]).
However, Eggert in view of Grace, Takahashi, and Beyar fails to disclose wherein the multiple emission regions comprise one or more reliefs in the optical fiber configured such that the multiple emission regions emit electromagnetic energy in a radial pattern from the optical fiber.
Harschack is directed towards a laser ablation device. Harschack discloses an optical fiber with conical emission regions configured such that the emission regions emit electromagnetic energy in a radial pattern from the optical fiber (e.g. Par. [0038]: two radiation zones shaped as a cone).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Eggert in view of Grace, Takahashi, and Beyar r to include an optical fiber with conical emission regions as taught by Harschack, because doing so would provide a laser treatment that enhances the speed of removal, ease of handling, and effective vessel ablation (e.g. Harschack, par. [0017]).
Regarding claim 38, Eggert further discloses wherein: the expandable member comprises a fluid (e.g. Par. [0049]); and the emission of electromagnetic energy from the emission regions is configured to create fractures in the coronary calcium by generating ultrasonic waves in the fluid (e.g. Par. [0050]).
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Takahashi et al. (US Patent Application Publication 2020/0093543 – of record), hereinafter Takahashi, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack, as applied to claim 40 above, and further in view of Cook et al. (US Patent Application Publication 2021/0186613), hereinafter Cook.
Regarding claim 45, Grace fails to disclose wherein a wavelength corresponding to the maximum absorption coefficient for the fluid contained in the expandable member is approximately equal to the wavelength of the electromagnetic energy emitted from the laser light source. Cook, in a similar field of endeavor, is directed towards a catheter system for treating vascular lesions. Cook discloses the fluid having an absorptive agent having a concentration that is tuned such that the wavelength corresponding to the maximum absorption coefficient for the fluid contained in the expandable member is approximately equal to the wavelength of the electromagnetic energy emitted from the laser light source (e.g. Par. [0071]: the agent can have an absorption maximum matched to the emission maximum of the laser).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Takahashi, Beyar, and Harschack to include the fluid containing an absorption matching the maximum absorption of the laser as taught by Cook, because doing so would result in the liquid medium absorbing all of the laser/light energy.
Claims 50 and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Takahashi et al. (US Patent Application Publication 2020/0093543 – of record), hereinafter Takahashi, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack, as applied to claim 37 above, and further in view of Masotti et al. (US Patent Application Publication 2021/0231886 – of record), hereinafter Masotti.
Regarding claim 50, Grace fails to disclose wherein the laser light source is a diode laser. Masotti is directed towards an optical fiber device. Masotti discloses wherein the laser light source is a diode laser (e.g. Par. [0033]: laser diode sources; Fig. 8: laser diode sources 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Takahashi, Beyar, and Harschack to include the laser being a diode laser as taught by Masotti, because doing so would provide the therapy light.
Regarding claim 58, Grace further discloses wherein the laser is configured to emit electromagnetic energy at an emission wavelength, and the fluid has an absorption coefficient at the emission wavelength (e.g. P Par. [0021]: light emitted from 1nm – 1mm; Par. [0274]: the liquid medium is configured to absorb the light energy and generate pressure waves).
However, Grace fails to specifically disclose wherein the laser light source is a diode laser. Masotti is directed towards an optical fiber device. Masotti discloses wherein the laser light source is a diode laser (e.g. Par. [0033]: laser diode sources; Fig. 8: laser diode sources 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Takahashi, Beyar, and Harschack to include the laser being a diode laser as taught by Masotti, because doing so would provide the therapy light.
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, further in view of Beyar et al. (US Patent Application Publication 2006/0190022 – of record), hereinafter Beyar, and further in view of Harschack et al. (US Patent Application Publication 2011/0282330 – of record), hereinafter Harschack, as applied to claim 1 above, and further in view of Masotti et al. (US Patent Application Publication 2021/0231886 – of record), hereinafter Masotti.
Regarding claim 55, Grace fails to disclose wherein the laser light source is a diode laser. Masotti is directed towards an optical fiber device. Masotti discloses wherein the laser light source is a diode laser (e.g. Par. [0033]: laser diode sources; Fig. 8: laser diode sources 5).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Grace in view of Beyar and Harschack to include the laser being a diode laser as taught by Masotti, because doing so would provide the therapy light.
Conclusion
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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