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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/30/2025 has been entered.
Response to Arguments
Regarding the 112a and 112b rejections, applicant’s amendments and related arguments, have been fully considered and are persuasive. The 112a and 112b rejections of claims 1-20, 23, 27, 29, 30 and 32-40 has been withdrawn.
Regarding the 103, applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The examiner has found new prior art references (WO 2020/033121 to Altshuler at al. or US 2017/0036253 to Lukac) and included them in a new 103 rejection; see below.
Regarding the previously applied 103 rejection of claim 37, specifically related to the Karni reference, the examiner takes the position that Karni teaches the necessary optical power density values to be capable of achieving the claimed result; see claim interpretation discussion below.
Claim Interpretation
For clarity, the limitation “a controller configured to control an optical power density of the laser light emitted by the light energy source, the optical power density causing the laser light to produce vaporization bubbles that create shock waves within the fluid without generating plasma within the fluid” does not preclude devices/prior art that teach plasma formation. As long as the controller is configured to control an optical power density of the laser to be below 1×1012 W/cm2 (from Par 0066 of applicant’s specification), then the optical power density is capable of achieving the claimed effect. This position is emphasized by applicant’s own arguments in relation to the 112 rejections. In these arguments, applicant makes it clear that the claimed effect, i.e. shockwave without plasma generation, depends on more than just the optical power density, e.g. the wavelength of the laser light and the particular fluid, and specifically how strongly the particular wavelength is absorbed by the particular fluid all factor into whether or not plasma is generated. It is also noted that other laser parameters, e.g. pulse duration, spot size, etc. also play a part in whether or not plasma is generated. It is emphasized that no other laser parameters (other than optical power density), e.g. wavelength, pulse duration, spot size, nor the specific type of fluid is required by the claims. Therefore, even if the prior art explicitly teaches plasma generation as an intended effect, that does not automatically preclude it from operating at the claimed optical power densities that can achieve shockwaves without plasma formation. Again, all that is required by applicant’s claim language is a controller that controls a laser to operate at an optical power density below 1×1012 W/cm2, as this optical power density is capable of providing the claimed effect. For example, even though Karni (Par 0021) discloses optical power densities of 100 W/cm2 that achieve shockwaves with plasma formation, these same power densities are also inherently capable of generating a shockwave without plasma formation, depending on other unclaimed/hypothetical factors, as made clear by applicant’s own specification and arguments.
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.
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.
Segalescu Rejection
Claims 1-20, 23, 27, 29, 30, 32-34 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0406010 to Massimini et al. in view of US 2016/0184023 to Grace et al. in view of US 2007/0282301 to Segalescu et al. and further in view of WO 2020/033121 to Altshuler et al. OR US 2017/0036253 to Lukac OR US 2021/0052292 to Karni
[Claims 1 and 37] Massimini discloses a laser lithotripsy system (best seen in Figs. 1 and 7; Par 0045 describes laser lithotripsy) comprising:
a light energy source (light source 116; Fig. 1); and
a catheter (101) including an optical fiber (light guide 700, as shown in Fig. 7; specifically disclosed as an optical fiber. Equivalent to light guide 110 shown in Fig. 1) at least partially surrounded by fluid (balloon fluid 124; Fig. 1) contained with a balloon of the catheter (balloon 122; Fig. 1 with light guide 110 contained within the balloon; at least Par 0054), the optical fiber configured to be optically coupled to receive laser light from the light energy source (Pars 0054-57, as well as Fig. 1, make it clear that light guide 700/110 is in optical communication with light source 116, in order to receive light 701), and the optical fiber comprising:
a lengthwise portion including a first evanescent portion (706 or 708; as seen in Fig. 7 these portions emit light out of the optical fiber, which is shown as element 714) contained within the balloon and a first non-evanescent portion (sections before, after or between any portion 706, 708 or 710 where the light 701, represented by arrows, is shown propagating through the optical fiber, i.e. not exiting the fiber) contained within the balloon (Par 0071);
a core (“The light guides herein can include a core surrounded by a cladding about its circumference” Par 0146);
a cladding (“The light guides herein can include a core surrounded by a cladding about its circumference” Par 0146) along the lengthwise portion, wherein the laser light propagating through the first evanescent portion is transmitted out of the optical fiber via an evanescent field and into the balloon (714 shows the light being transmitted out of the fiber at the evanescent portions and implicitly into the surrounding balloon, not shown in Fig. 7), wherein the laser light propagating through the first non-evanescent portion is not transmitted out of the optical fiber nor into the balloon (light 701, shown as arrows, propagates through the fiber, i.e. does not exit, at the non-evanescent portions; See Pars 0070-73 and Fig. 7);
a distal end (710) configured to emit the laser light (716/718) that propagates through the first evanescent portion;
While Massimini discloses a distal end of the optical fiber (710) configured to emit laser light that that is not transmitted out of the first evanescent portion, the reference fails to teach that this distal end is located outside the balloon. However, in the same field of endeavor, Grace discloses a similar laser balloon catheter used to treat vascular conditions using laser induced pressure waves (Abstract) that includes emitters located both inside and outside the balloon in order to specifically target different locations (Par 0224). Specifically, as shown in Fig. 1 and described in Par 0224, distal emitter (120) is located outside the balloon (distal tip 130) while proximal emitter (140) is located within the balloon. Therefore, it would have been obvious to one of ordinary skill in the art to modify the catheter of Massimini such that the distal end of the fiber (710) is located outside of the balloon, in order to direct laser light towards desired targets, as this is known configuration used in similar devices for the same treatment, as taught by Grace.
Massimini and Grace are discussed above but fail to explicitly teach that the cladding fully encases the evanescent portion of the fiber, i.e. the window. However, in the same field of endeavor, Segalescu teaches “still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section.” It’s clear that in this embodiment of Segalescu, the cladding remains on the core as light is emitted from the optical fiber, and this is achieved by including a tapered thinner cross-section of the core and/or cladding. Therefore, it would have been obvious to one ordinary skill in the art to substitute the evanescent portions, i.e. diffusers/windows (706 and 708) of Massimini, for the tapered core and/or cladding, where the cladding surrounds the core, as taught by Segalescu, as a simple substitution of one known configuration of an optical fiber that emits/scatters/diffuses light radially or circumferentially out of an optical fiber for another known configuration that provides the same function.
Massimini, Grace and Segalescu fail to explicitly teach the claimed controller. However, in the same field of endeavor, Altshuler makes it clear that there are two known pathways to generate a shockwave, specifically a direct or linear interaction that involves no plasma generation or a non-linear interaction that involves the generation of plasma (“Cavitation involves the growth and collapse of cavities within liquid, and can cause damage to surrounding solid material. Laser energy can also lead to plasma formation on the matter. Plasma formation is achieved through fast matter ionization with optical breakdown, which is a non-linear effect produced when laser radiation is strongly absorbed by irradiated matter and/or with high power density on the target. In liquid treatment environments, laser-induced bubble formation in the liquid is caused by direct or plasma-mediated absorption. This absorption creates a growing vapor bubble. Although the growing vapor bubble may not reach the stone, energy from the pulse is still absorbed by the liquid.”; Page 3). Alternatively, Lukac discloses the same exact common-knowledge within the art of laser surgery, specifically there are two different known mechanisms to produce a shockwave in a liquid, specifically a non-linear regime at high power densities that ionizes the liquid and produces plasma (similar to what is taught by Massimini) and a linear regime at lower power densities that does not involve ionization/plasma (see Pars 0020-23 of Lukac). Specifically, Lukac makes it clear that the non-linear effect, i.e. ionization/plasma formation, takes place at higher optical power densities in the range of 1010 to 1011 W/cm2, and that the linear effect, i.e. no ionization/plasma formation, takes place at optical power densities lower than this. Therefore, it would have been obvious to modify the device taught by Massimini, Grace and Segalescu to include a controller that controls the optical power density of the laser light such that a shockwave is created without plasma generation, i.e. lower than 1010 to 1011 W/cm2, as taught by either Altshuler or Lukac, this is a simple substitution of one known technique for generating shockwaves in a liquid (non-linear with ionization and plasma formation) for another (linear without ionization/plasma formation) to obtain predictable results, i.e. generating shockwaves in a liquid to treat tissue, as this is the ultimate goal of Massimini. Stated differently, it would be obvious to try either approach (linear or non-linear) when generating shockwaves in a liquid, and it’s known that when using the linear approach the optical power density must be below the threshold for ionization/plasma formation, as taught by either Altshuler or Lukac.
Further regarding the claimed controller, in an alternative interpretation, Karni, which is in the same field of endeavor, discloses that sufficient power density (at least 100 W/cm2) is required in order to produce the plasma which leads to the shockwave/pressure wave. (Par 0021). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to modify the device of Massimini, Grace and Segalescu to include a controller that controls the laser at a power density within the claimed range, and more specifically at least 100 W/cm2, as this is a known power density that provides the desired effect in tissue, as taught by Karni. As discussed above, in the claim interpretation section, the claims only require a controller that operates in an optical power density of below 1×1012 W/cm2, which has substantial overlap with the range greater than 100 W/cm2, therefore the proposed combination of Massimini, Grace, Segalescu and Karni teach/suggest a device that is inherently capable of providing the claimed effect, depending on various unclaimed and hypothetical factors, e.g. wavelength, type of fluid, pulse duration, spot size, etc.; see MPEP 2114.
[Claims 2 and 5] As discussed above, Segalescu discloses that it is known to provide evanescent portions (radial light energy emitting section 31) via a tapering of the optical fiber core (Pars 0091-93; “Still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section.”).
[Claim 3, 4 and 7] Segalescu fails to explicitly disclose the radius/diameters of the tapered and non-tapered portions of the core, nor does it explicitly disclose the angle at which it tapers, but the reference makes it clear that the taper angle of the core is a result effective variable in order to emit light out of the fiber. It is noted that the radius/diameters of the two portions merely serve to define the taper angle. Applicant has no disclosed criticality to these radii or taper angles; therefore this is merely just a routine optimization of a result effective variable; MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art to choose/try various diameters and taper angles that achieve the necessary critical angle for the desired result of emitting light out of an optical fiber, as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Furthermore, “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” MPEP 2144.04. Therefore, it would have been obvious to change the size/ proportion of the core radius and/or taper angle, as matter of routine design and engineering choice through normal experimentation.
[Claim 6] As discussed above, Massimini explicitly discloses multiple non-evanescent portions located on either/both side(s) of evanescent portions (706, 708 pr 710; Fig. 7). Furthermore, as discussed above, Segalescu explicitly discloses that in order to achieve an evanescent portion, a core of a non-evanescent portion has to taper (sloped/inclined surface that reduces diameter/radius of the core). The claimed configuration of reducing and increasing the radius of the core is merely how the specific embodiment of Massimini (Fig. 7), i.e. an embodiment having spaced apart non-evanescent portions with an evanescent portion located in between, is achieved by tapering (which achieves the evanescent portion) and then un-tapering (which achieves the non-evanescent portions) the core, as taught by Segalescu.
[Claims 8, 11, 14 and 15] As discussed above, Segalescu discloses that it is known to provide evanescent portions (radial light energy emitting section 31) via a tapering of the optical fiber cladding (Pars 0091-93; “Still alternative optical designs (not illustrated) for emitting a radial confined light-energy are based on the usage of an optical fiber with a tapered thinner cross-section (core and/or cladding) for the radial light-energy emitting section 31 causing dispersion of a light wave in this thinner section.”). While Fig. 3b is directed to a different embodiment where the cladding is removed from the evanescent portion (31) and replaced with a tapered coating layer (311), it serves as a suitable depiction of what is described in Par 0093 of a tapered thinner cladding; the only difference is that the cladding from evanescent portion (31) would not be removed, instead the cladding from the non-evanescent portion (33) would just be gradually thinned/tapered in the same/similar manner to how the tapered coating layer 311 is tapered. As seen in Fig. 3B, the non-evanescent portion (33) has a thicker cladding, i.e. larger outer radius, than the evanescent portion (31), which has a tapering cladding (311; which is being interpreted as cladding, and not a coating layer, in view of the disclosure in Par 0093 of a tapered thinner cross-section of cladding) including an outer radius that continuously varies, i.e. reduces/gets thinner, along its length.
[Claims 9, 10, 13, 16-20] These claims all recite different dimensions, proportions or parameters that serve to define the tapering. While Segalescu is silent to specific examples for these dimensions, proportions or parameters, it’s clear that Segalescu establishes the tapering/thinning of the cladding and/or core as a result effective variable, specifically a reduced/thinning/tapered cladding and/or core provides the desired effect of radially emitting light out of an optical fiber. Applicant has no disclosed criticality to these radii, taper angles or ratios between cladding and core; therefore this is merely just a routine optimization of a result effective variable; MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art to choose/try various diameters and taper angles that achieve the necessary critical angle for the desired result of emitting light out of an optical fiber, as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Furthermore, “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” MPEP 2144.04. Therefore, it would have been obvious to change the size/ proportion of the cladding radius, taper angle, or ratio between cladding and core as matter of routine design and engineering choice through normal experimentation.
[Claim 12] As discussed above, Massimini explicitly discloses multiple non-evanescent portions located on either/both side(s) of evanescent portions (706, 708 pr 710; Fig. 7). Furthermore, as discussed above, Segalescu explicitly discloses that in order to achieve an evanescent portion, the cladding of non-evanescent portion has to taper (sloped/inclined surface that reduces diameter of the cladding). The claimed configuration of reducing and increasing the radius of the cladding is merely how the specific embodiment of Massimini (Fig. 7), i.e. an embodiment having spaced apart non-evanescent portions with an evanescent portion located in between, is achieved by tapering (which achieves the evanescent portion) and then un-tapering (which achieves the non-evanescent portions) the cladding, as taught by Segalescu.
[Claim 23] Massimini is silent as to how much light exits portions 706 or 708. As explained in detail below in relation to claims 27 and 39-40, it’s clear that the amount of light reduces each time it passes an evanescent portion and it appears as if this amount/percentage that exits each evanescent portion is based on how many evanescent portions exists along the length of the fiber. Furthermore, applicant has provided no criticality or unexpected results to this percentage as the specification makes it clear that “An optical fiber 104 may have a single evanescent portion 112(a), as shown in FIGS. 8A-8C, in which case at least 35%, at least 40%, at least 45%, at least 50%, at least 55%, at least 56%, at least 57%, at least 58%, at least 59%, or at least 60%, of the light that is provided to optical fiber 104 by laser light source 114 may be transmitted out of evanescent portion 112(a) in the form of evanescent fields”. Therefore, based on all of the above, it would be obvious for one of ordinary skill in the art to try/choose emitting at least 55% of the light out of the first evanescent portion, especially if/when only one evanescent portion exists, as there are only so many possibilities, in terms of distribution of light. Furthermore, "where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
[Claims 27, 39-40] As made clear from claim 1 above, the examiner is interpreting portions 706 and 708 to be the evanescent portions, and portion 710 as the distal end configured to emit light that is not transmitted out of the other evanescent portions (706 and 708). Inherently/implicitly, the light that is not emitted out of the fiber at evanescent portions 706 and 708 is emitted out of the distal end 710. While Massimini fails to explicitly disclose what percentage of light exits the optical fiber at each evanescent portions (706 and 708), and therefore it’s not explicitly taught how much of this light is remaining to exit at the distal end (710), the figures provide some guidance, specifically the number of arrows (701; which represent the light) decrease from 3 to 2, and then from 2 to 1, as they pass each evanescent section. At the very least, it makes it clear that the percentage of light decreases each time it passes an evanescent portion on its way to the distal tip, with the remaining portion being transmitted out of the distal end. More specifically, this seems to imply that 1/3 (33%) of the light is remaining after the second evanescent section (708) and is the amount of light that exits the distal end. Furthermore, it seems as if the percentage of light is based on how many emitting/evanescent portions exist. In Massimini, there are 2 evanescent portions and 1 end-firing portion, i.e. 3 portions of the fiber that emit light, therefore it makes sense that the light is evenly distributed so that the same amount of light is emitted out of each portion. Furthermore, applicant has no criticality or unexpected result to the claimed range. Therefore, based on all of the above, it would be obvious for one of ordinary skill in the art to try emitting 25% to 40% of the light out of the distal end of the optical fiber, e.g. an equal distribution of 1/3 at each of the three emitting portions (including the distal tip), as this is seemingly implied by Massimini and/or a logical distribution to try, as there are only so many possibilities, in terms of distribution of light
[Claims 29-30] Pars 0142-144 disclose various options for the balloon fluid, e.g. water. The claimed absorption coefficient is an inherent characteristic/property of at least water. Specifically, applicant also discloses water as an example of an aqueous fluid that has the desired absorption coefficient (see Par 0090 of applicant’s specification).
[Claims 32-33] Pars 0164-165 discuss different options for the light source and wavelengths thereof, including an Nd:YAG laser which emits at 1064 nm (1.064 microns); see Par 0144.
[Claim 34] Inherently, an optical fiber, which operates by total internal reflection, has a core with an index of refraction higher than an index of refraction of the cladding. This is inherently how total internal reflection works in an optical fiber in order to guide the light along the fiber length (https://en.wikipedia.org/wiki/Cladding_(fiber_optics))
[Claim 38] This is considered an inherent effect/characteristic of an evanescent field/wave which is inherently produced by the tapered cross-section of the core/cladding as taught by Segalescu; see MPEP 2112 and 2114.
Claims 35 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Massimini, Grace and Segalescu as applied to claim 1 above, and further in view of US 2006/0285798 to Brekke et al.
As discussed in relation to claim 34 (above), inherently the index of refraction of the core must be higher than the index of refraction of the cladding. The specific index of refraction for these elements comes down to choosing known materials for claddings and cores of optical fibers. MPEP 2144.07 makes it clear that “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination”. Brekke, in the same field of endeavor, makes it clear that it’s known to choose a material for the cladding with an index of refraction of 1.42 and a material for the core with an index of refraction of 1.44 (Par 0060). Therefore, it would have been obvious to one of ordinary skill in the art to choose/try materials for the core and cladding of the optical fiber having the necessary index of refraction in order to ensure total internal reflection, including the specific/known examples of 1.42 for the cladding and 1.44 for the core, as taught by Brekke, as this is merely the selection of a known material based on suitability for its intended purpose.
Mamiya Rejection
Claims 1-7 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0406010 to Massimini et al. in view of US 2016/0184023 to Grace in view of US 2022/0370821 to Mamiya and further in view of WO 2020/033121 to Altshuler et al. OR US 2017/0036253 to Lukac OR US 2021/0052292 to Karni
[Claims 1, 2, 5 and 37] Massimini discloses a laser lithotripsy system (best seen in Figs. 1 and 7; Par 0045 describes laser lithotripsy) comprising:
a light energy source (light source 116; Fig. 1); and
a catheter (101) including an optical fiber (light guide 700, as shown in Fig. 7; specifically disclosed as an optical fiber. Equivalent to light guide 110 shown in Fig. 1) at least partially surrounded by fluid (balloon fluid 124; Fig. 1) contained with a balloon of the catheter (balloon 122; Fig. 1 with light guide 110 contained within the balloon; at least Par 0054), the optical fiber configured to be optically coupled to receive laser light from the light energy source (Pars 0054-57, as well as Fig. 1, make it clear that light guide 700/110 is in optical communication with light source 116, in order to receive light 701), and the optical fiber comprising:
a lengthwise portion including a first evanescent portion (706 or 708; as seen in Fig. 7 these portions emit light out of the optical fiber, which is shown as element 714) contained within the balloon and a first non-evanescent portion (sections before, after or between any portion 706, 708 or 710 where the light 701, represented by arrows, is shown propagating through the optical fiber, i.e. not exiting the fiber) contained within the balloon (Par 0071);
a core (“The light guides herein can include a core surrounded by a cladding about its circumference” Par 0146);
a cladding (“The light guides herein can include a core surrounded by a cladding about its circumference” Par 0146) along the lengthwise portion, wherein the laser light propagating through the first evanescent portion is transmitted out of the optical fiber via an evanescent field and into the balloon (714 shows the light being transmitted out of the fiber at the evanescent portions and implicitly into the surrounding balloon, not shown in Fig. 7) so that the fluid is heated and produces vaporization bubbles that create shock waves without generating plasma (the optical fiber of Massimini is capable of transmitting light having parameters that can achieve the claimed effect in a particular fluid; see MPEP 2114), wherein the laser light propagating through the first non-evanescent portion is not transmitted out of the optical fiber nor into the balloon (light 701, shown as arrows, propagates through the fiber, i.e. does not exit, at the non-evanescent portions; See Pars 0070-73 and Fig. 7);
a distal end (710) configured to emit the laser light (716/718) that propagates through the first evanescent portion;
While Massimini discloses a distal end of the optical fiber (710) configured to emit laser light that that is not transmitted out of the first evanescent portion, the reference fails to teach that this distal end is located outside the balloon. However, in the same field of endeavor, Grace discloses a similar laser balloon catheter used to treat vascular conditions using laser induced pressure waves (Abstract) that includes emitters located both inside and outside the balloon in order to specifically target different locations (Par 0224). Specifically, as shown in Fig. 1 and described in Par 0224, distal emitter (120) is located outside the balloon (distal tip 130) while proximal emitter (140) is located within the balloon. Therefore, it would have been obvious to one of ordinary skill in the art to modify the catheter of Massimini such that the distal end of the fiber (710) is located outside of the balloon, in order to direct laser light towards desired targets, as this is known configuration used in similar devices for the same treatment, as taught by Grace.
Massimini and Grace are discussed above but fail to explicitly teach that the cladding fully encases the evanescent portion of the fiber, i.e. the window. However, in the same field of endeavor, Mamiya (Fig. 21) discloses a tapered core (11a) that is fully encased with cladding (11b) that emits light radially out of the fiber (Par 0087). Therefore, it would have been obvious to one ordinary skill in the art to substitute the evanescent portions, i.e. diffusers/windows 706 and 708, of Massimini for the tapered core, where the cladding surrounds the core, as taught by Mamiya, as a simple substitution of one known configuration of an optical fiber that emits/scatters/diffuses light radially or circumferentially out of an optical fiber for another known configuration that provides the same function.
Massimini, Grace and Mamiya fail to explicitly teach the claimed controller. However, in the same field of endeavor, Altshuler makes it clear that there are two known pathways to generate a shockwave, specifically a direct or linear interaction that involves no plasma generation or a non-linear interaction that involves the generation of plasma (“Cavitation involves the growth and collapse of cavities within liquid, and can cause damage to surrounding solid material. Laser energy can also lead to plasma formation on the matter. Plasma formation is achieved through fast matter ionization with optical breakdown, which is a non-linear effect produced when laser radiation is strongly absorbed by irradiated matter and/or with high power density on the target. In liquid treatment environments, laser-induced bubble formation in the liquid is caused by direct or plasma-mediated absorption. This absorption creates a growing vapor bubble. Although the growing vapor bubble may not reach the stone, energy from the pulse is still absorbed by the liquid.”; Page 3). Alternatively, Lukac discloses the same exact common-knowledge within the art of laser surgery, specifically there are two different known mechanisms to produce a shockwave in a liquid, specifically a non-linear regime at high power densities that ionizes the liquid and produces plasma (similar to what is taught by Massimini) and a linear regime at lower power densities that does not involve ionization/plasma (see Pars 0020-23 of Lukac). Specifically, Lukac makes it clear that the non-linear effect, i.e. ionization/plasma formation, takes place at higher optical power densities in the range of 1010 to 1011 W/cm2, and that the linear effect, i.e. no ionization/plasma formation, takes place at optical power densities lower than this. Therefore, it would have been obvious to modify the device taught by Massimini, Grace and Mamiya to include a controller that controls the optical power density of the laser light such that a shockwave is created without plasma generation, i.e. lower than 1010 to 1011 W/cm2, as taught by either Altshuler or Lukac, as this is a simple substation of known technique for generating shockwaves in a liquid (non-linear with ionization and plasma formation) for another (linear without ionization/plasma formation) to obtain predictable results, i.e. generating shockwaves in a liquid to treat tissue, as this is the ultimate goal of Massimini. Stated differently, it would be obvious to try either approach (linear or non-linear) when generating shockwaves in a liquid, and it’s known that when using the linear approach the optical power density must be below the threshold for ionization/plasma formation, as taught by either Altshuler or Lukac.
Further regarding the claimed controller, in an alternative interpretation, Karni, which is in the same field of endeavor, discloses that sufficient power density (at least 100 W/cm2) is required in order to produce the plasma which leads to the shockwave/pressure wave. (Par 0021). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to modify the device of Massimini, Grace and Mamiya to include a controller that controls the laser at a power density within the claimed range, and more specifically at least 100 W/cm2, as this is a known power density that provides the desired effect in tissue, as taught by Karni. As discussed above, in the claim interpretation section, the claims only require a controller that operates in an optical power density of below 1×1012 W/cm2, which has substantial overlap with the range greater than 100 W/cm2, therefore the proposed combination of Massimini, Grace, Mamiya and Karni teach/suggest a device that is inherently capable of providing the claimed effect, depending on various unclaimed and hypothetical factors, e.g. wavelength, type of fluid, pulse duration, spot size, etc.; see MPEP 2114.
[Claim 3, 4 and 7] Mamiya fails to explicitly disclose the radius/diameters of the tapered and non-tapered portions of the core, nor does it explicitly disclose the angle at which it tapers, but the reference makes it clear that the taper angle of the core is a result effective variable in order to emit light out of the fiber. It is noted that the radius/diameters of the two portions merely serve to define the taper angle. Applicant has no disclosed criticality to these radii or taper angles; therefore this is merely just a routine optimization of a result effective variable; MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art to choose/try various diameters and taper angles that achieve the necessary critical angle for the desired result of emitting light out of an optical fiber, as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Furthermore, “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” MPEP 2144.04. Therefore, it would have been obvious to change the size/ proportion of the core radius and/or taper angle, as matter of routine design and engineering choice through normal experimentation.
[Claim 6] As discussed above, Massimini explicitly discloses multiple non-evanescent portions located on either/both side(s) of evanescent portions (706, 708 pr 710; Fig. 7). Furthermore, as discussed above, Mamiya explicitly discloses that in order to achieve an evanescent portion, a core of a non-evanescent portion has to taper (sloped/inclined surface that reduces diameter/radius of the core). The claimed configuration of reducing and increasing the radius of the core is merely how the specific embodiment of Massimini (Fig. 7), i.e. an embodiment having spaced apart non-evanescent portions with an evanescent portion located in between, is achieved by tapering (which achieves the evanescent portion) and then un-tapering (which achieves the non-evanescent portions) the core, as taught by Mamiya.
[Claim 38] This is considered an inherent effect/characteristic of an evanescent field/wave which is inherently produced by the tapered cross-section of the core/cladding as taught by Mamiya; see MPEP 2112 and 2114.
[Claims 39-40] The examiner takes the position that inherently/implicitly the light 701 that is not transmitted out of the evanescent portions (706 and 708) must/necessarily exit out of the distal end (710). Therefore, implicitly/inherently the light that is emitted out of the distal end is based on the light emitted via the evanescent fields, as only the remaining light is emitted out of the distal end. Furthermore, it seems clear from Fig. 7 that the amount of light is reduced after each evanescent portion, specifically the number of arrows (701; which represent the light) decrease from 3 to 2, and then from 2 to 1, as they pass each evanescent section. At the very least, it makes it clear that the percentage of light decreases each time it passes an evanescent portion on its way to the distal tip, with the remaining portion being transmitted out of the distal end. More specifically, this seems to imply that 1/3 (33%) of the light is remaining after the second evanescent section (708) and is the amount of light that exits the distal end. Furthermore, it seems as if the percentage of light is based on how many emitting/evanescent portions exist. In Massimini, there are 2 evanescent portions and 1 end-firing portion, i.e. 3 portions of the fiber that emit light, therefore it makes sense that the light is evenly distributed so that the same amount of light is emitted out of each portion.
Baker/Skutnik rejection
Claims 1, 8-20 and 37-40 are rejected under 35 U.S.C. 103 as being unpatentable over US 2020/0406010 to Massimini et al. in view of US 2016/0184023 to Grace in further view of US 2003/0128944 to Skutnik OR US 5,042,980 to Baker et al. and further in view of WO 2020/033121 to Altshuler et al. OR US 2017/0036253 to Lukac OR US 2021/0052292 to Karni
[Claims 1, 8, 11, 14, 15 and 37] Massimini discloses a laser lithotripsy system (best seen in Figs. 1 and 7; Par 0045 describes laser lithotripsy) comprising:
a light energy source (light source 116; Fig. 1); and
a catheter (101) including an optical fiber (light guide 700, as shown in Fig. 7; specifically disclosed as an optical fiber. Equivalent to light guide 110 shown in Fig. 1) at least partially surrounded by fluid (balloon fluid 124; Fig. 1) contained with a balloon of the catheter (balloon 122; Fig. 1 with light guide 110 contained within the balloon; at least Par 0054), the optical fiber configured to be optically coupled to receive laser light from the light energy source (Pars 0054-57, as well as Fig. 1, make it clear that light guide 700/110 is in optical communication with light source 116, in order to receive light 701), and the optical fiber comprising:
a lengthwise portion including a first evanescent portion (706 or 708; as seen in Fig. 7 these portions emit light out of the optical fiber, which is shown as element 714) contained within the balloon and a first non-evanescent portion (sections before, after or between any portion 706, 708 or 710 where the light 701, represented by arrows, is shown propagating through the optical fiber, i.e. not exiting the fiber) contained within the balloon (Par 0071);
a core (“The light guides herein can include a core surrounded by a cladding about its circumference” Par 0146);
a cladding (“The light guides herein can include a core surrounded by a cladding about its circumference” Par 0146) along the lengthwise portion, wherein the laser light propagating through the first evanescent portion is transmitted out of the optical fiber via an evanescent field and into the balloon (714 shows the light being transmitted out of the fiber at the evanescent portions and implicitly into the surrounding balloon, not shown in Fig. 7) so that the fluid is heated and produces vaporization bubbles that create shock waves without generating plasma (the optical fiber of Massimini is capable of transmitting light having parameters that can achieve the claimed effect in a particular fluid; see MPEP 2114), wherein the laser light propagating through the first non-evanescent portion is not transmitted out of the optical fiber nor into the balloon (light 701, shown as arrows, propagates through the fiber, i.e. does not exit, at the non-evanescent portions; See Pars 0070-73 and Fig. 7);
a distal end (710) configured to emit the laser light (716/718) that propagates through the first evanescent portion;
While Massimini discloses a distal end of the optical fiber (710) configured to emit laser light that that is not transmitted out of the first evanescent portion, the reference fails to teach that this distal end is located outside the balloon. However, in the same field of endeavor, Grace discloses a similar laser balloon catheter used to treat vascular conditions using laser induced pressure waves (Abstract) that includes emitters located both inside and outside the balloon in order to specifically target different locations (Par 0224). Specifically, as shown in Fig. 1 and described in Par 0224, distal emitter (120) is located outside the balloon (distal tip 130) while proximal emitter (140) is located within the balloon. Therefore, it would have been obvious to one of ordinary skill in the art to modify the catheter of Massimini such that the distal end of the fiber (710) is located outside of the balloon, in order to direct laser light towards desired targets, as this is known configuration used in similar devices for the same treatment, as taught by Grace.
Massimini and Grace are discussed above but fail to explicitly teach that the cladding fully encases the evanescent portion of the fiber, i.e. the window. However, in the same field of endeavor, Baker (Fig. 3) discloses providing an evanescent field/diffusing tip by tapering the cladding (48) of an optical fiber (Abstract; Col 7; “In particular, the cladding can be tapered from thicker at the proximal end 24a of diffusion tip 24 where it connects to optical fiber 32 to thinner at the distal end 24b thereof. The gradual reduction in the thickness of cladding 48 produces a more uniform pattern.”). Similarly, Skutnik a diffusing tip that radially emits light by tapering the cladding of an optical fiber (Fig. 2; Par 0050). Therefore, it would have been obvious to one ordinary skill in the art to substitute the evanescent portions, i.e. diffusers/windows 706 and 708, of Massimini for the tapered cladding, where the cladding surrounds the core, as taught by Baker or Skutnik, as a simple substitution of one known configuration of an optical fiber that emits/scatters/diffuses light radially or circumferentially out of an optical fiber for another known configuration that provides the same function.
Massimini, Grace and Baker/Skutnik fail to explicitly teach the claimed controller. However, in the same field of endeavor, Altshuler makes it clear that there are two known pathways to generate a shockwave, specifically a direct or linear interaction that involves no plasma generation or a non-linear interaction that involves the generation of plasma (“Cavitation involves the growth and collapse of cavities within liquid, and can cause damage to surrounding solid material. Laser energy can also lead to plasma formation on the matter. Plasma formation is achieved through fast matter ionization with optical breakdown, which is a non-linear effect produced when laser radiation is strongly absorbed by irradiated matter and/or with high power density on the target. In liquid treatment environments, laser-induced bubble formation in the liquid is caused by direct or plasma-mediated absorption. This absorption creates a growing vapor bubble. Although the growing vapor bubble may not reach the stone, energy from the pulse is still absorbed by the liquid.”; Page 3). Alternatively, Lukac discloses the same exact common-knowledge within the art of laser surgery, specifically there are two different known mechanisms to produce a shockwave in a liquid, specifically a non-linear regime at high power densities that ionizes the liquid and produces plasma (similar to what is taught by Massimini) and a linear regime at lower power densities that does not involve ionization/plasma (see Pars 0020-23 of Lukac). Specifically, Lukac makes it clear that the non-linear effect, i.e. ionization/plasma formation, takes place at higher optical power densities in the range of 1010 to 1011 W/cm2, and that the linear effect, i.e. no ionization/plasma formation, takes place at optical power densities lower than this. Therefore, it would have been obvious to modify the device taught by Massimini, Grace and Baker/Skutnik to include a controller that controls the optical power density of the laser light such that a shockwave is created without plasma generation, i.e. lower than 1010 to 1011 W/cm2, as taught by either Altshuler or Lukac, as this is a simple substation of known technique for generating shockwaves in a liquid (non-linear with ionization and plasma formation) for another (linear without ionization/plasma formation) to obtain predictable results, i.e. generating shockwaves in a liquid to treat tissue, as this is the ultimate goal of Massimini. Stated differently, it would be obvious to try either approach (linear or non-linear) when generating shockwaves in a liquid, and it’s known that when using the linear approach the optical power density must be below the threshold for ionization/plasma formation, as taught by either Altshuler or Lukac.
Further regarding the claimed controller, in an alternative interpretation, Karni, which is in the same field of endeavor, discloses that sufficient power density (at least 100 W/cm2) is required in order to produce the plasma which leads to the shockwave/pressure wave. (Par 0021). MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to modify the device of Massimini, Grace and Baker/Skutnik to include a controller that controls the laser at a power density within the claimed range, and more specifically at least 100 W/cm2, as this is a known power density that provides the desired effect in tissue, as taught by Karni. As discussed above, in the claim interpretation section, the claims only require a controller that operates in an optical power density of below 1×1012 W/cm2, which has substantial overlap with the range greater than 100 W/cm2, therefore the proposed combination of Massimini, Grace, Baker/Skutnik and Karni teach/suggest a device that is inherently capable of providing the claimed effect, depending on various unclaimed and hypothetical factors, e.g. wavelength, type of fluid, pulse duration, spot size, etc.; see MPEP 2114.
[Claims 9, 10, 13, 16-20] These claims all recite different dimensions, proportions or parameters that serve to define the tapering. While Baker or Skutnik are silent to specific examples for these dimensions, proportions or parameters, it’s clear that Baker or Skutnik establish the tapering/thinning of the cladding as a result effective variable, specifically a reduced/thinning/tapered cladding and/or core provides the desired effect of radially emitting light out of an optical fiber. Applicant has no disclosed criticality to these radii, taper angles or ratios between cladding and core; therefore this is merely just a routine optimization of a result effective variable; MPEP 2144.05. Therefore, it would have been obvious to one of ordinary skill in the art to choose/try various diameters and taper angles that achieve the necessary critical angle for the desired result of emitting light out of an optical fiber, as it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.”
Furthermore, “the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” MPEP 2144.04. Therefore, it would have been obvious to change the size/ proportion of the cladding radius, taper angle, or ratio between cladding and core as matter of routine design and engineering choice through normal experimentation.
[Claim 12] As discussed above, Massimini explicitly discloses multiple non-evanescent portions located on either/both side(s) of evanescent portions (706, 708 pr 710; Fig. 7). Furthermore, as discussed above, Baker or Skutnik explicitly disclose that in order to achieve an evanescent portion, the cladding of non-evanescent portion has to taper (sloped/inclined surface that reduces diameter of the cladding). The claimed configuration of reducing and increasing the radius of the cladding is merely how the specific embodiment of Massimini (Fig. 7), i.e. an embodiment having spaced apart non-evanescent portions with an evanescent portion located in between, is achieved by tapering (which achieves the evanescent portion) and then un-tapering (which achieves the non-evanescent portions) the cladding, as taught by Baker or Skutnik.
[Claim 38] This is considered an inherent effect/characteristic of an evanescent field/wave which is inherently produced by the tapered cross-section of the core/cladding as taught by Baker or Skutnik; see MPEP 2112 and 2114.
[Claims 39-40] The examiner takes the position that inherently/implicitly the light 701 that is not transmitted out of the evanescent portions (706 and 708) must/necessarily exit out of the distal end (710). Therefore, implicitly/inherently the light that is emitted out of the distal end is based on the light emitted via the evanescent fields, as only the remaining light is emitted out of the distal end. Furthermore, it seems clear from Fig. 7 that the amount of light is reduced after each evanescent portion, specifically the number of arrows (701; which represent the light) decrease from 3 to 2, and then from 2 to 1, as they pass each evanescent section. At the very least, it makes it clear that the percentage of light decreases each time it passes an evanescent portion on its way to the distal tip, with the remaining portion being transmitted out of the distal end. More specifically, this seems to imply that 1/3 (33%) of the light is remaining after the second evanescent section (708) and is the amount of light that exits the distal end. Furthermore, it seems as if the percentage of light is based on how many emitting/evanescent portions exist. In Massimini, there are 2 evanescent portions and 1 end-firing portion, i.e. 3 portions of the fiber that emit light, therefore it makes sense that the light is evenly distributed so that the same amount of light is emitted out of each portion.
Conclusion
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796