DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1, 7, 9, 12-13, 20, 22, 28, 31, 46-47, 49, 52-53, 55-56, 60, and 62 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0333588 Lieber et al., hereinafter “Lieber” (cited previously), in view of WO 2022/029920 Katsurada et al., hereinafter “Katsurada”.
Regarding claim 1, Lieber discloses a system (Abstract and Figure 1, element 100), comprising: a catheter body (Figure 1, element 120); a light conduit at least partially disposed within the catheter body (Figure 1, element 132 and Para 37); a light emitter (Figure 1, element 130 is at a distal end of element 132) including a distal tip of the light conduit (Tip of element 132 to the left is the light emitter 130 which is distal to the conduit 132 in Figure 1) the light conduit configured to convey light from a light source to the distal tip (See Figure 1, light source LS conveys light into conduit 132 that transmits it to emitter 130), the distal tip of the light conduit, when disposed in a body cavity of a patient near a target tissue region (Para 42 and 44), configured to: reflect a first portion of light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit (See Figures 2A and B that show that the light is disposed out of the light conduit 132 in multiple angles that are not zero relative to the central axis) such that the first portion is transmitted through a sidewall of the light conduit to the target tissue region at a first intensity (Para 42 and 85, see also Para 57, without using light scattering means) and refract a second portion of the light conveyed by the light conduit to the distal tip distally of the light emitter (Para 42, 85, and 57; using light scattering means, see specifically Para 43 that discusses refractive structures); and a light scatterer (Figure 1 and 2A, element 136 is in the tip of the device, refer to this with the 103 rejection below) coupled to the light emitter and configured to diffuse the second portion of the light such that the second portion of the light (Para 47) is transmitted to a non-target tissue region at second intensity lower than the first intensity (This is inherent, when light is delivered via a scattering element, the intensity is reduced as the scattering particles absorb some of the energy; and instead of delivering light directly to the target site, it is inherent that when light is scattered, some non-targeted regions are affected by this light).
Lieber does not disclose the distal tip of the light emitter is set at a non-zero angle relative to a central axis of the light conduit being configured to reflect the first portion of the light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit such that the first portion is transmitted through a sidewall of the light conduit and refract a second portion of the light conveyed by the light conduit to the distal tip distally of the light emitter.
However, Katsurada discloses a catheter illumination system (Para 1 and 20) and teaches the distal tip (Figure 9B, element 23) of the light emitter (Figure 9B, element 22) is set at a non-zero angle relative to a central axis of the light conduit (Figure 9B, tip 23 is set at an angle Ѳb relative to central axis O) being configured to reflect the first portion of the light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit such that the first portion is transmitted through a sidewall of the light conduit (Figure 9B, it is clear from the figure that a first portion of the light is reflected by tip 23 and transmitted through the bottom sidewall) and refract a second portion of the light conveyed by the light conduit to the distal tip distally of the light emitter (Figure 9B, it is clear from the figure that a second portion is refracted into the emitter 22).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a distal end at a non-zero surface as taught by Katsurada, in the invention of Lieber, in order to hit the target tissue at the proper angle and reflect and refract the light (Katsurada; Para 53).
Regarding claim 7, Lieber discloses the light scatterer and the light emitter are configured such that the second portion of light is diffused by the light scatterer axially and laterally relative to a central axis of the light scatterer, the light scatterer and the light conduit being coaxial (see Figures 2A and B; the light scatterer 136 is axially aligned with 132 and diffuses light laterally and axially, see also Para 44).
Regarding claim 9, Lieber discloses a spacing member (Figure 1, element 150) configured to transition between a collapsed configuration and an expanded configuration (Para 33), in the expanded configuration the spacing member configured to be disposed about the light emitter to maintain the light emitter approximately centered with respect to at least one axis of the spacing member (Para 33), the spacing member configured to maintain the light emitter centered between opposing tissue walls defining the body cavity in the expanded configuration (Para 33 and 34).
Regarding claim 12, Lieber discloses the spacing member has a conical shape in the expanded configuration such that the spacing member defines a conical space (Para 49) within which the light emitter is at least partially disposed (Figure 4A, element 130 is within 150).
Regarding claim 13, Lieber discloses the spacing member has an open distal end (See Figure 4C, the distal end of 150 is open) and defines an interior space in the expanded configuration (Figure 4A and C, the interior space that holds element 130,136) within which the light emitter is at least partially disposed (Figure 4A, element 130 is within the interior space), the spacing member including a frame portion (Annotated Figure 4C, the frame is what helps collapse and expand the spacing member) and a membranous cover portion (Figure 4C, element 155).
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Annotated Figure 4C
Regarding claim 20, Lieber discloses a system (Abstract and Figure 1, element 100), comprising: a catheter body (Figure 1, element 120); a light conduit at least partially disposed within the catheter body (Figure 1, element 132 and Para 37); and a light emitter (Figure 1, element 130 is at a distal end of element 132) including a distal tip of the light conduit (Tip of element 132 to the left is the light emitter 130 which is distal to the conduit 132 in Figure 1) the light conduit configured to convey light from a light source to the distal tip (See Figure 1, light source LS conveys light into conduit 132 that transmits it to emitter 130), the distal tip of the light conduit, when disposed in a body cavity of a patient near a target tissue region (Para 42 and 44) configured to: reflect a first portion of light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit (See Figures 2A and B that show that the light is disposed out of the light conduit 132 in multiple angles that are not zero relative to the central axis) such that the first portion is transmitted through a sidewall of the light conduit to the target tissue region (Para 42 and 85, see also Para 57; Figure 2B shows the transmission through the sidewalls); and refract a second portion of the light conveyed by the light conduit to the distal tip such that the second portion of the light is emitted distally of the light emitter (Para 42, 85, and 57; using light scattering means, see specifically Para 43 that discusses refractive structures)
Lieber does not disclose the distal tip of the light emitter is set at a non-zero angle relative to a central axis of the light conduit being configured to reflect the first portion of the light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit such that the first portion is transmitted through a sidewall of the light conduit and refract a second portion of the light conveyed by the light conduit to the distal tip such that the second portion of the light is emitted distally of the light emitter.
However, Katsurada discloses a catheter illumination system (Para 1 and 20) and teaches the distal tip (Figure 9B, element 23) of the light emitter (Figure 9B, element 22) is set at a non-zero angle relative to a central axis of the light conduit (Figure 9B, tip 23 is set at an angle Ѳb relative to central axis O) being configured to reflect the first portion of the light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit such that the first portion is transmitted through a sidewall of the light conduit (Figure 9B, it is clear from the figure that a first portion of the light is reflected by tip 23 and transmitted through the bottom sidewall) and refract a second portion of the light conveyed by the light conduit to the distal tip such that the second portion of the light is emitted distally of the light emitter (Figure 9B, it is clear from the figure that a second portion is refracted into the emitter 22).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a distal end at a non-zero surface as taught by Katsurada, in the invention of Lieber, in order to hit the target tissue at the proper angle and reflect and refract the light (Katsurada; Para 53).
Regarding claim 22, Lieber discloses the catheter body (Figure 1, element 120) defines a first fluid conduit (Figure 1, element 140) configured to be fluidically coupled to a fluid source (Figure 1, fluid source FS) and a second fluid conduit configured to be coupled to a fluid sink (This is interpreted broadly and can be interpreted as elements 157 that discharge the fluid, see Para 53), the first fluid conduit and the second fluid conduit configured to be in fluid communication with the body cavity such that a pressure within the body cavity can be maintained within a range via at least one of providing fluid from the fluid source to the body cavity via the first fluid conduit or drawing fluid from the body cavity to the fluid sink via the second fluid conduit (Para 53).
Regarding claim 28, Lieber discloses a spacing member (Figure 1, element 150) configured to transition between a collapsed configuration and an expanded configuration (Para 33), in the expanded configuration the spacing member configured to be disposed about the light emitter to maintain the light emitter approximately centered with respect to at least one axis of the spacing member (Para 33), the spacing member configured to maintain the light emitter centered between opposing tissue walls defining the body cavity in the expanded configuration (Para 33 and 34).
Regarding claim 31, Lieber discloses the spacing member has a conical shape in the expanded configuration such that the spacing member defines a conical space (Para 49) within which the light emitter is at least partially disposed (Figure 4A, element 130 is within 150).
Regarding claim 46, Lieber discloses a method (Abstract and Para 2), comprising: generating light using a light source coupled to a catheter having a distal end (Figure 1, element 120, distal end is light emitter 130) disposed within a body cavity of a subject near a target region of tissue to be treated (Para 42 and 44), the catheter including: a catheter body (Figure 1, element 120) and a light conduit (Figure 1, element 132 and Para 37) terminating in a distal tip (Figure 1, distal end connected to light emitter 130) and conveying, via the light conduit, the light from the light source to the distal tip of the light conduit (See Figure 1, light is coming from light source LS to conduit 132 to emitter 130) such that the distal tip (1) reflects a first portion of the light asymmetrically and at a non-zero angle relative to a central axis of the light conduit (See Figures 2A and B that show that the light is disposed out of the light conduit 132 in multiple angles that are not zero relative to the central axis, see also Para 42 and 85, see also Para 57, see Figure 2B) and (2) refracts a second portion of the light distally of the distal tip (Para 42, 85, and 57; using light scattering means, see specifically Para 43 that discusses refractive structures); and transmitting the first portion of the light through a sidewall of the light conduit and emitting the first portion of the light onto the target region of tissue (Figure 2B).
Lieber does not disclose a light conduit terminating in a distal tip that is set at a non-zero angle relative to a central axis of the light conduit and reflect the first portion of the light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit such that the first portion is transmitted through a sidewall of the light conduit and refract a second portion of the light distally of the distal tip.
However, Katsurada discloses a catheter illumination system (Para 1 and 20) and teaches a light conduit terminating in a distal tip (Figure 9B, element 23) that is set at a non-zero angle relative to a central axis of the light conduit (Figure 9B, tip 23 is set at an angle Ѳb relative to central axis O) being configured to reflect the first portion of the light conveyed by the light conduit to the distal tip asymmetrically and at a non-zero angle relative to the central axis of the light conduit such that the first portion is transmitted through a sidewall of the light conduit (Figure 9B, it is clear from the figure that a first portion of the light is reflected by tip 23 and transmitted through the bottom sidewall) and refract a second portion of the light distally of the distal tip (Figure 9B, it is clear from the figure that a second portion is refracted into the emitter 22).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed a distal end at a non-zero surface as taught by Katsurada, in the invention of Lieber, in order to hit the target tissue at the proper angle and reflect and refract the light (Katsurada; Para 53).
Regarding claim 47, Lieber discloses the target region of tissue includes brain tissue (Para 32), and the body cavity is a space adjacent the brain tissue including cerebrospinal fluid (Para 32).
Regarding claim 49, Lieber discloses the catheter (Figure 1, element 120) includes a first fluid conduit (Figure 1, element 140) and a second fluid conduit (This is interpreted broadly and can be interpreted as elements 157 that discharge the fluid, see Para 53), the method further comprising: maintaining a pressure within the body cavity within a range via at least one of providing fluid to the body cavity via the first fluid conduit or drawing fluid from the body cavity via the second fluid conduit (Para 53).
Regarding claim 52, Lieber discloses the catheter includes a spacing member (Figure 1, element 150) configured to transition between a collapsed configuration and an expanded configuration (Para 33), in the expanded configuration the spacing member configured to maintain the distal tip approximately centered with respect to at least one axis of the spacing member (Para 33), and further comprising: transitioning the spacing member from the collapsed configuration to the expanded configuration within the body cavity such that the distal tip is centered between opposing tissue walls defining the body cavity (Para 33 and 34).
Regarding claim 53, Lieber discloses the spacing member is at least partially transmissive and/or transflective, and the emitting the first portion of the light includes emitting the first portion of the light through the spacing member (Para 33).
Regarding claim 55, Lieber discloses the emitting the first portion of the light includes emitting the first portion of the light at a power and for a duration sufficient to deliver to the target region of tissue (Claim 14) an amount of light energy sufficient to recruit stem cells locally and/or remotely, and to initiate differentiation, activation and proliferation of the cells including multipotent stem cells, blood forming stem cells, and/or mesenchymal stem cells, vascular stem cells, endothelial precursor or progenitor cells, and/or differentiated cells such as fibroblasts and collagen to produce a photochemical effect in the target region of tissue (Claim 14).
Regarding claim 56, Lieber discloses emitting the first portion of the light includes emitting light at a wavelength between 400 nm and 1,100 nm (Para 57).
Regarding claim 60, Lieber discloses the emitting the first portion of the light includes not emitting the first portion of the light onto a non-target region of tissue adjacent to the target region of tissue (Para 70; treatment of adjacent region is not mentioned).
Regarding claim 62, Lieber discloses the target region of tissue includes at least a portion of a chronic subdural hematoma cavity (Para 32).
Claim(s) 18, 37, and 59 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0333588 Lieber et al., hereinafter “Lieber”, in view of WO 2022/029920 Katsurada et al., hereinafter “Katsurada”, further in view of US 2013/0289358 Melsky et al., hereinafter “Melsky” (cited previously).
Regarding claim 18, Lieber discloses the light source coupleable to a proximal end of the light conduit (Figure 1, light source LS is on the proximal end of 136) and configured to generate the light at a wavelength in a visible portion of an electromagnetic spectrum (Para 42 and 57) and such that the target tissue region receiving the first portion of the light reflected by the distal tip of the light conduit (Figures 1 and 2B)
Lieber does not disclose the target tissue region receiving the light is provided an energy dose of between 0.05 J/cm2 and 250 J/cm2.
However, Melsky teaches the target tissue region receiving the light is provided an energy dose of between 0.05 J/cm2 and 250 J/cm2 (Para 75).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the specific energy dose as taught by Melsky, in the invention of Lieber, in order to treat the lesions (Melsky; Para 75).
Regarding claim 37, Lieber discloses the light source coupleable to a proximal end of the light conduit (Figure 1, light source LS is on the proximal end of 136) and configured to generate light at a wavelength in a visible portion of an electromagnetic spectrum (Para 42 and 57) and such that the target tissue region receiving the first portion of the light reflected by the distal tip of the light conduit (Figures 1 and 2B).
Lieber does not disclose the target tissue region receiving the light is provided an energy dose of between 0.05 J/cm2 and 250 J/cm2.
However, Melsky teaches the target tissue region receiving the light is provided an energy dose of between 0.05 J/cm2 and 250 J/cm2 (Para 75).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the specific energy dose as taught by Melsky, in the invention of Lieber, in order to treat the lesions (Melsky; Para 75).
Regarding claim 59, Lieber discloses all the limitations of claim 46.
Lieber does not disclose emitting the first portion of the light to provide an energy dose of between 0.05 J/cm2 and 250 J/cm2 to the target tissue region .
However, Melsky emitting light to provide an energy dose of between 0.05 J/cm2 and 250 J/cm2 to the target tissue region (Para 75).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the specific energy dose as taught by Melsky, in the invention of Lieber, in order to treat the lesions (Melsky; Para 75).
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection.
Refer to 103 rejection above for the rejection of the newly amended claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796