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 .
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed 03/07/2024, 05/24/2024, 07/31/2024, 10/28/2024, 01/28/2025, 04/21/2025, and 05/20/2025 have been considered by the Examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 7-9, 14, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carlin et al (US 20080077225 A1).
Regarding claim 1, Carlin teaches a catheter system for treating a treatment site within or adjacent to a vessel wall of a blood vessel, the catheter system (30) comprising:
a balloon (20) that is positionable substantially adjacent to the vessel wall at the treatment site (see [0022]; stent delivery system into a body cavity or vessel lumen comprising a catheter having a balloon disposed over the distal portion of the catheter),
the balloon (20) having a balloon wall (inner balloon wall 40) that defines a balloon interior;
a first assembly illumination source (one of optical emitting fibers 601-606 of optical probe 39) that generates a first assembly illumination beam (50) that moves in a first direction into the balloon interior (see Fig. 4, [0058]; optical path of light 50 is emitted in an outward direction towards balloon interior/lumen); and
a contact detector assembly (see [0015]; the detector may receive optical radiation back from the surrounding area of the lumen which is transmitted through the plurality of optical emitting fibers) that is configured to optically analyze a first returning energy beam from the balloon interior that moves in a second direction that is opposite the first direction (see Fig. 4, [0057-0058]; backscattered light is received at the optical emitting fiber within optical probe 39),
the contact detector assembly being configured to analyze the first returning energy beam to determine a contact condition between the balloon wall and the vessel wall (see Figs. 4 and 6, [0015]; the processor may be in communication with the detector and may control expansion of the balloon based on processing of the optical radiation signals provided by the plurality of optical emitting fibers, [0048]; the LCI backscattered signal may be used to determine the linear distance between the optical emitting fiber, a stent disposed on a balloon, and the lumen wall).
Regarding claim 7, Carlin teaches the catheter system of claim 1 further comprising a beam guide (see [0054]; optical emitting fibers includes hollow air-filled tubes with reflecting inner walls, which are considered to be a beam guide);
wherein the first assembly illumination beam moves in the first direction through the beam guide from a guide proximal end to a guide distal end (see [0053]; optical probe contains multiple optical emitting fibers each of which terminate in an optical head that deflects and possibly shapes the emitted optical radiation pattern, the optical head considered to be located at the distal end) that is positioned within the balloon interior (see Fig. 7; optical emitting fibers 601-606 disposed in optical probe 39 located within the interior of balloon 20),
the first assembly illumination beam including first light energy (see [0018]; the optical radiation may be low coherence light or light of any wavelength suitable); and
wherein the first returning energy beam moves in the second direction through the beam guide from the guide distal end to the guide proximal end (see [0057]; the optical emitting fibers within the optical probe 39 receive light scattered back from structures which may include the balloon wall or vessel lumen),
the first returning energy beam including second light energy from at least a portion of the first light energy being reflected from the vessel wall (see Figs. 4 and 5 illustrating plots of light energy reflected back from structures outside the optical probe which may include the vessel wall).
Regarding claim 8, Carlin teaches the catheter system of claim 7 further comprising a second assembly illumination source (one of optical emitting fibers 601-606 of optical probe 39) that generates a second assembly illumination beam (50) that moves in the first direction into the balloon interior (see Fig. 7 illustrating multiple optical emitting fibers 601-606 each emitting a illumination beam 50 in a first direction, where the first direction is identified as ‘outward’ from the central optical probe 39 to the balloon/vessel wall); and
wherein the contact detector assembly (see [0015]; processor may be in communication with detector) is configured to optically analyze a second returning energy beam from the balloon interior that moves in the second direction that is opposite the first direction (see [0048]; the LCI backscattered signal may be used to determine the linear distance between the optical emitting fiber, a stent disposed on a balloon, and the lumen wall, [0073]; Fig. 8 showing measurement of the radial distances for each of the optical emitting fibers),
the contact detector assembly being configured to analyze the first returning energy beam and the second returning energy beam to determine the contact condition between the balloon wall and the vessel wall (see [0069]; the physical distance from any interface j to any interface k, where the interfaces are any of the interfaces labeled 1-6 in Fig. 4, along the light-path of the mth optical emitting fiber can be designated from one another, Fig. 6 shows a representation of the optical path lengths that demonstrates the balloon fully expanded to the artery wall when the LCI trace W from the balloon wall nearly overlaps the trace A of the artery wall).
Regarding claim 9, Carlin teaches the catheter system of claim 8 wherein the second assembly illumination beam (50) moves in the first direction through the beam guide (see [0054]; optical emitting fibers includes hollow air-filled tubes with reflecting inner walls, which are considered to be a beam guide) from the guide proximal end to the guide distal end (see [0053]; optical probe contains multiple optical emitting fibers each of which terminate in an optical head that deflects and possibly shapes the emitted optical radiation pattern, where the optical head is considered to be located at the distal end) that is positioned within the balloon interior (see Fig. 7; optical emitting fibers 601-606 disposed in optical probe 39 located within the interior of balloon 20),
the second assembly illumination beam including first light energy (see [0018]; the optical radiation may be low coherence light or light of any wavelength suitable); and
wherein the second returning energy beam moves in the second direction through the beam guide from the guide distal end to the guide proximal end (see [0048]; the LCI backscattered signal may be used to determine the linear distance between the optical emitting fiber, a stent disposed on a balloon, and the lumen wall, [0073]; Fig. 8 showing measurement of the radial distances for each of the optical emitting fibers),
the second returning energy beam including second light energy from at least a portion of the first light energy from the second assembly illumination beam being reflected from blood that is positioned between the balloon wall and the vessel wall (see [0069]; the physical distance from any interface j to any interface k, where the interfaces are any of the interfaces labeled 1-6 in Fig. 4, along the light-path of the mth optical emitting fiber can be designated from one another, Fig. 6 shows a representation of the optical path lengths that demonstrates the balloon fully expanded to the artery wall when the LCI trace W from the balloon wall nearly overlaps the trace A of the artery wall).
Regarding claim 14, Carlin teaches a method for treating a treatment site within or adjacent to a vessel wall of a blood vessel, the method comprising the steps of:
positioning a balloon (20) substantially adjacent to the vessel wall (10) at the treatment site (see [0022]; stent delivery system into a body cavity or vessel lumen comprising a catheter having a balloon disposed over the distal portion of the catheter),
the balloon having a balloon wall (inner balloon wall 40) that defines a balloon interior;
generating a first assembly illumination beam (50) with a first assembly illumination source (one of optical emitting fibers 601-606 of optical probe 39);
moving the first assembly illumination beam in a first direction into the balloon interior see Fig. 4, [0058]; optical path of light 50 is emitted in an outward direction towards balloon interior/lumen);
moving a first returning energy beam from the balloon interior in a second direction that is opposite the first direction (see Fig. 4, [0057-0058]; backscattered light is received at the optical emitting fiber within optical probe 39); and
optically analyzing the first returning energy beam from the balloon interior with a contact detector assembly (see [0015]; the detector may receive optical radiation back from the surrounding area of the lumen which is transmitted through the plurality of optical emitting fibers) to determine a contact condition between the balloon wall and the vessel wall (see Figs. 4 and 6, [0048]; the LCI backscattered signal may be used to determine the linear distance between the optical emitting fiber, a stent disposed on a balloon, and the lumen wall).
Regarding claim 18, Carlin teaches the method of claim 14 further comprising the steps of generating a second assembly illumination beam (50) with a second assembly illumination source (one of optical emitting fibers 601-606 of optical probe 39);
moving the second assembly illumination beam in the first direction into the balloon interior (see Fig. 7 illustrating multiple optical emitting fibers 601-606 each emitting aN illumination beam 50 in a first direction, where the first direction is identified as ‘outward’ from the central optical probe 39 to the balloon/vessel wall); and
moving a second returning energy beam from the balloon interior in the second direction that is opposite the first direction (see [0048]; the LCI backscattered signal is received by the optical emitting fibers, where a backscattered signal is considered to move in a second direction opposite to the first direction where the first direction is ‘outward’ away from the optical prob and the second direction is ‘inward’ towards the optical probe); and
wherein the step of optically analyzing includes optically analyzing the first returning energy beam and the second returning energy beam from the balloon interior with the contact detector assembly to determine the contact condition between the balloon wall and the vessel wall (see [0069]; the physical distance from any interface j to any interface k, where the interfaces are any of the interfaces labeled 1-6 in Fig. 4, along the light-path of the mth optical emitting fiber can be designated from one another, Fig. 6 shows a representation of the optical path lengths that demonstrates the balloon fully expanded to the artery wall when the LCI trace W from the balloon wall nearly overlaps the trace A of the artery wall).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 2-6 and 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlin et al (US 20080077225 A1) in view of Zhai et al (US 20230027712 A1).
Regarding claim 2, Carlin teaches the catheter system of claim 1 wherein the balloon is configured to receive and retain a catheter fluid within the balloon interior (see Carlin [0050]; balloon may be inflatable through the catheter with an inflation fluid such as saline).
Carlin is silent regarding wherein the catheter system further comprises a pressure sensor assembly including
a pressure sensor that is configured to sense an internal balloon pressure of the catheter fluid within the balloon interior,
the pressure sensor being in fluid communication with the catheter fluid retained within the balloon interior.
Zhai teaches a catheter system (102) comprising a balloon (112) that is positionable substantially adjacent to the vessel wall at a treatment site wherein the balloon is configured to receive and retain a catheter fluid within the balloon interior (see Zhai [0011]; filling a balloon within a body lumen with a fluid); and
wherein the catheter system (102) further comprises a pressure sensor assembly (cartridge 130) including
a pressure sensor (pressure sensor P1, P2, and/or P3) that is configured to sense an internal balloon pressure of the catheter fluid within the balloon interior (see Zhai [0097]; one or more pressure sensors P1, P2, and P3 can be used to monitor the pressure in the balloon 112),
the pressure sensor being in fluid communication with the catheter fluid retained within the balloon interior (see Zhai [0099]; pressure sensors P1, P2, and P3 can be used to monitor the fluidic pressure at various points along the fluidic paths which can be provided to the controller 120 for purposes such as monitoring the fluidic pressure within the balloon 112).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with the pressure sensing assembly as taught by Zhai. One of ordinary skill in the art would have been motivated to make this modification in order to monitor the fluid pressure within the balloon of a catheter system for the safety of the patient and for providing measurements to a control system (Zhai [0099]).
Regarding claim 3, Carlin and Zhai teach the catheter system of claim 2. Carlin is silent regarding
a balloon compliance chart that plots an outer diameter of the balloon versus the internal balloon pressure, and
a balloon diameter determination system that determines the outer diameter of the balloon based on the sensed internal balloon pressure and the balloon compliance chart.
Zhai teaches a balloon compliance chart that plots an outer diameter of the balloon versus the internal balloon pressure (see Zhai Fig. 18), and
a balloon diameter determination system that determines the outer diameter of the balloon based on the sensed internal balloon pressure and the balloon compliance chart (see Zhai [0067]; balloon 112 is a compliant balloon configured to inflate between a first diameter and a second diameter using an inflation pressure between a first inflation pressure and a second inflation pressure such that the outer diameter is directly correlated with the pressure of the balloon 112).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with Zhai’s balloon compliance chart to plot a balloon diameter with an internal balloon pressure. One of ordinary skill in the art would have been motivated to make this modification in order to obtain a reference curve which may then be used in comparison with a measured parameter curve to determine the size of a corresponding body lumen with relation to a balloon diameter (Zhai [0010], [0222]).
Regarding claim 4, Carlin and Zhai teach the catheter system of claim 3. Carlin further teaches the contact detector assembly (see [0015]; processor may be in communication with detector) configured to analyze the first returning energy beam (50) to determine when good contact exists between the balloon wall and the vessel wall (see [0048]; the LCI backscattered signal may be used to determine the linear distance between the optical emitting fiber, a stent disposed on a balloon, and the lumen wall); and
wherein the contact detector assembly determines that good contact exists between the balloon wall and the vessel wall (see [0069]; the physical distance from any interface j to any interface k, where the interfaces are any of the interfaces labeled 1-6 in Fig. 4, along the light-path of the mth optical emitting fiber can be designated from one another, Fig. 6 shows a representation of the optical path lengths that demonstrates the balloon fully expanded to the artery wall when the LCI trace W from the balloon wall nearly overlaps the trace A of the artery wall).
Carlin is silent regarding a vessel diameter determination system that is configured to determine an inner diameter of the blood vessel; and
the vessel diameter determination system determines that the inner diameter of the blood vessel is equal to the outer diameter of the balloon when the contact detector assembly determines that good contact exists between the balloon wall and the vessel wall.
Zhai teaches a vessel diameter determination system that is configured to determine an inner diameter of the blood vessel (see Zhai [0010-0011]; a system to determine the size of a body lumen based on a comparison to a parameter curve);
wherein the vessel diameter determination system determines that the inner diameter of the blood vessel is equal to the outer diameter of the balloon (see Zhai Fig. 19B, [0231-0233]; the size of the body lumen is determined based on the comparison between the parameter curve 20004 and the reference curve 2002) when the balloon is determined to be in contact with the vessel wall (see Zhai [0233]; the body lumen size can be determined using a comparison between inflection points, [0370]; estimate a size of a portion of a body lumen based on sensor measurements taken between time t1, when a balloon is sufficiently inflated such that the pressure is at least that of an environmental pressure and time t2 when the balloon becomes in apposition with the portion of the body lumen).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system having a contact detection assembly with Zhai’s vessel diameter determination system. One of ordinary skill in the art would have been motivated to make this modification in order to determine the size of a body lumen or vessel so that an appropriate dose of therapeutic energy is used for a desired treatment (Zhai [0104]).
Regarding claim 5, Carlin and Zhai teach the catheter system of claim 4. Carlin is silent regarding wherein the treatment site has a site length; and
wherein the vessel diameter determination system is configured to determine the inner diameter of the blood vessel at multiple locations along the site length of the treatment site.
Zhai teaches wherein the treatment site has a site length (see Zhai Fig. 17; 1702 measure length of body lumen); and
wherein the vessel diameter determination system is configured to determine the inner diameter of the blood vessel at multiple locations along the site length of the treatment site (see Zhai Fig. 17, [0219]; the controller 120 may use the diameter measurement determined at step 1720, which may be based on pressure sensor measurements at step 1714, to determine if the balloon should be deflated and moved and the diameter determination at step 1714/1716/1817 should be repeated).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with Zhai’s diameter determination system wherein the diameter determination system is configured to measure the lumen diameter at multiple locations. One of ordinary skill in the art would have been motivated to make this modification in order to determine that the present portion of the lumen has an expected diameter before applying any therapeutic treatment to the vessel (Zhai [0219]).
Regarding claim 6, Carlin and Zhai teach the catheter system of claim 5. Carlin is silent regarding a system controller including one or more processors, and
a diameter correlation system that is at least partially integrated within the system controller; and
wherein the diameter correlation system is configured to utilize data from the balloon diameter determination system regarding the outer diameter of the balloon, and
data from the vessel diameter determination system regarding the inner diameter of the blood vessel at the multiple locations along the site length of the treatment site,
for purposes of ensuring a proper correlation of the outer diameter of the balloon and the inner diameter of the blood vessel during use of the catheter system in a therapeutic procedure.
Zhai teaches a system controller (120) including one or more processors (612), and
a diameter correlation system that is at least partially integrated within the system controller (see Zhai [0102]; processor 612 can use sensor measurements from one or more of the pressure sensors to estimate an inner diameter of a body lumen); and
wherein the diameter correlation system is configured to utilize data from the balloon diameter determination system regarding the outer diameter of the balloon (see Zhai [0067]; balloon 112 is a compliant balloon configured to inflate between a first diameter and a second diameter using an inflation pressure between a first inflation pressure and a second inflation pressure such that the outer diameter is directly correlated with the pressure of the balloon 112), and
data from the vessel diameter determination system regarding the inner diameter of the blood vessel at the multiple locations along the site length of the treatment site (see Zhai Fig. 17, [0219]; the controller 120 may use the diameter measurement determined at step 1720, which may be based on pressure sensor measurements at step 1714, to determine if the balloon should be deflated and moved and the diameter determination at step 1714/1716/1817 should be repeated),
for purposes of ensuring a proper correlation of the outer diameter of the balloon and the inner diameter of the blood vessel during use of the catheter system in a therapeutic procedure (see Zhai [0102]; using sensor measurements from the one or more pressure sensors to determine when the balloon 112 is in apposition with a body lumen as well as to estimate an inner diameter of the body lumen).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with the diameter correlation system as taught by Zhai. One of ordinary skill in the art would have been motivated to make this modification in order to determine the appropriate dose of energy for a therapeutic treatment to be applied to a vessel based on the size of the body lumen (Zhai [0104]).
Regarding claim 15, Carlin teaches the method of claim 14. Carlin further teaches the steps of receiving and retaining a catheter fluid within the balloon interior (see Carlin [0050]; balloon may be inflatable through the catheter with an inflation fluid such as saline).
Carlin is silent regarding sensing an internal balloon pressure of the catheter fluid within the balloon interior with a pressure sensor of a pressure sensor assembly; and
determining an outer diameter of the balloon with a balloon diameter determination system based on the sensed internal balloon pressure and a balloon compliance chart that plots the outer diameter of the balloon versus the internal balloon pressure.
Zhai teaches receiving and retaining a catheter fluid within the balloon interior (see Zhai [0011]; filling a balloon within a body lumen with a fluid);
sensing an internal balloon pressure of the catheter fluid within the balloon interior (see Zhai [0097]; one or more pressure sensors P1, P2, and P3 can be used to monitor the pressure in the balloon 112) with a pressure sensor (pressure sensor P1, P2, and/or P3) of a pressure sensor assembly (cartridge 130); and
determining an outer diameter of the balloon with a balloon diameter determination system based on the sensed internal balloon pressure (see Zhai [0067]; balloon 112 is a compliant balloon configured to inflate between a first diameter and a second diameter using an inflation pressure between a first inflation pressure and a second inflation pressure such that the outer diameter is directly correlated with the pressure of the balloon 112) and a balloon compliance chart that plots the outer diameter of the balloon versus the internal balloon pressure (see Zhai Fig. 18).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s method for treating a site within or adjacent to a vessel wall with a catheter system having a balloon with a pressure sensing assembly and diameter determination system as taught by Zhai. One of ordinary skill in the art would have been motivated to make this modification in order to monitor balloon conditions including pressure and diameter for the safety of the patient and for providing measurements to a control system (Zhai [0099]).
Regarding claim 16, Carlin and Zhai teach the method of claim 15.
Carlin further teaches wherein the step of optically analyzing includes optically analyzing the first returning energy beam (see [0048]; the LCI backscattered signal may be used to determine the linear distance between the optical emitting fiber, a stent disposed on a balloon, and the lumen wall) with the contact detector assembly (see [0015]; processor may be in communication with detector) to determine when good contact exists between the balloon wall and the vessel wall; and
wherein the contact detector assembly determines that good contact exists between the balloon wall and the vessel wall (see [0069]; the physical distance from any interface j to any interface k, where the interfaces are any of the interfaces labeled 1-6 in Fig. 4, along the light-path of the mth optical emitting fiber can be designated from one another, Fig. 6 shows a representation of the optical path lengths that demonstrates the balloon fully expanded to the artery wall when the LCI trace W from the balloon wall nearly overlaps the trace A of the artery wall).
Carlin is silent regarding determining an inner diameter of the blood vessel with a vessel diameter determination system; and
the vessel diameter determination system determining that the inner diameter of the blood vessel is equal to the outer diameter of the balloon when the contact detector assembly determines that good contact exists between the balloon wall and the vessel wall.
Zhai teaches determining an inner diameter of the blood vessel with a vessel diameter determination system (see Zhai [0010-0011]; a system to determine the size of a body lumen based on a comparison to a parameter curve);
wherein the vessel diameter determination system determines that the inner diameter of the blood vessel is equal to the outer diameter of the balloon (see Zhai Fig. 19B, [0231-0233]; the size of the body lumen is determined based on the comparison between the parameter curve 20004 and the reference curve 2002) when the balloon is determined to be in contact with the vessel wall (see Zhai [0233]; the body lumen size can be determined using a comparison between inflection points, [0370]; estimate a size of a portion of a body lumen based on sensor measurements taken between time t1, when a balloon is sufficiently inflated such that the pressure is at least that of an environmental pressure and time t2 when the balloon becomes in apposition with the portion of the body lumen).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s method of treatment of a site within or adjacent to a vessel wall with a catheter system having a contact detection assembly with Zhai’s vessel diameter determination system. One of ordinary skill in the art would have been motivated to make this modification in order to determine the size of a body lumen or vessel so that an appropriate dose of therapeutic energy is used for a desired treatment (Zhai [0104]).
Regarding claim 17, Carlin and Zhai teach the method of claim 16. Carlin is silent regarding wherein the step of determining the inner diameter of the blood vessel includes determining the inner diameter of the blood vessel with the vessel diameter determination system at multiple locations along the site length of the treatment site; and
further comprising the step of ensuring a proper correlation of the outer diameter of the balloon and the inner diameter of the blood vessel during use of the catheter system in a therapeutic procedure with a diameter correlation system that is at least partially integrated within a system controller including one or more processors,
the diameter correlation system utilizing data from the balloon diameter determination system regarding the outer diameter of the balloon, and
data from the vessel diameter determination system regarding the inner diameter of the blood vessel at the multiple locations along the site length of the treatment site.
Zhai teaches wherein the treatment site has a site length (see Zhai Fig. 17; 1702 measure length of body lumen); and
wherein the step of determining the inner diameter of the blood vessel includes determining the inner diameter of the blood vessel with the vessel diameter determination system at multiple locations along the site length of the treatment site (see Zhai Fig. 17, [0219]; the controller 120 may use the diameter measurement determined at step 1720, which may be based on pressure sensor measurements at step 1714, to determine if the balloon should be deflated and moved and the diameter determination at step 1714/1716/1817 should be repeated); and
further comprising the step of ensuring a proper correlation of the outer diameter of the balloon and the inner diameter of the blood vessel (see Zhai [0102]; using sensor measurements from the one or more pressure sensors to determine when the balloon 112 is in apposition with a body lumen as well as to estimate an inner diameter of the body lumen) during use of the catheter system in a therapeutic procedure with a diameter correlation system that is at least partially integrated within a system controller (120) including one or more processors (612),
the diameter correlation system utilizing data from the balloon diameter determination system regarding the outer diameter of the balloon (see Zhai [0067]; balloon 112 is a compliant balloon configured to inflate between a first diameter and a second diameter using an inflation pressure between a first inflation pressure and a second inflation pressure such that the outer diameter is directly correlated with the pressure of the balloon 112), and
data from the vessel diameter determination system regarding the inner diameter of the blood vessel at the multiple locations along the site length of the treatment site (see Zhai Fig. 17, [0219]; the controller 120 may use the diameter measurement determined at step 1720, which may be based on pressure sensor measurements at step 1714, to determine if the balloon should be deflated and moved and the diameter determination at step 1714/1716/1817 should be repeated).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s method for treatment of a site within or adjacent to a vessel wall with a catheter system with the diameter correlation system as taught by Zhai. One of ordinary skill in the art would have been motivated to make this modification in order to determine the appropriate dose of energy for a therapeutic treatment to be applied to a vessel based on the size of the body lumen (Zhai [0104]).
Claim(s) 7 and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlin et al (US 20080077225 A1) in view of Cook et al (US 20210290305 A1).
Regarding claim 7, Carlin teaches the catheter system of claim 1 and the catheter system of claim 7 further comprising a beam guide as detailed in the section above.
Additionally, Cook teaches a catheter system (100) comprising a balloon (104) and a first assembly illumination source (124), further comprising a beam guide (122A);
wherein the first assembly illumination beam moves in the first direction (121F) through the beam guide (122A) from a guide proximal end (122P) to a guide distal end (122D) that is positioned within the balloon interior (see Cook [0048]; each light guide 122A can guide light along its length from a proximal portion 122P to a distal end 122D having at least one optical window that is positioned within the balloon interior 146),
the first assembly illumination beam including first light energy (see Cook [0065-0067]; light source 124 may be an infrared laser that emits light energy); and
wherein the first returning energy beam moves in the second direction through the beam guide from the guide distal end to the guide proximal end (see Cook Fig. 1, [0049]; light energy can move in a second direction 121S which is opposite to first direction 121F from the guide distal end 122D to the guide proximal end 122P),
the first returning energy beam including second light energy from at least a portion of the first light energy being reflected from the vessel wall (see Cook [0049]; the light moving in the second direction 121S can be optically detected, interrogated, and/or analyzed through use of the optical analyzer assembly 142, [0055]; light guides 122A can further include one or more diverters configured to direct light to exit the light guide 122A near the guide distal end 122D and towards the balloon wall 130).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the catheter system of Carlin having a first illumination assembly with the illumination assembly taught by Cook. One of ordinary skill in the art would have been motivated to make this modification in order to guide and analyze an energy beam transmitted in an outward direction towards a vessel wall (Cook [0026]).
Regarding claim 11, Carlin and/or Carlin in view of Cook teach the catheter system of claim 7.
Carlin further teaches the catheter system (30) comprising an energy source (optical fiber 39) that generates a source beam that is directed into the balloon interior (see Carlin Fig. 4, [0058]; optical path of light 50 is emitted in an outward direction towards balloon interior/lumen, it can be appreciated that under its broadest reasonable interpretation, the light beam 50 emitted from optical emitting fibers 601-606 of optical probe 39 meets the limitation of ‘a source beam’);
wherein the source beam (50) is directed through the beam guide (optical emitting fiber 601-606) from a guide proximal end (guidewire 32) to a guide distal end that is positioned within the balloon interior (see Carlin Fig. 7; optical emitting fibers 601-606 disposed in optical probe 39 located within the interior of balloon 20),
wherein the balloon is configured to receive and retain a catheter fluid within the balloon interior (see Carlin [0012]; the balloon may be expanded or contracted by fluid or gas delivered through the catheter).
Carlin is silent regarding wherein the source beam being directed into the balloon interior induces generation of a plasma in the catheter fluid within the balloon interior.
Cook teaches an energy source (light source 124) that generates a source beam (124A) that is directed into the balloon interior (see Cook [0048]; guide light to the guide distal end 122D having at least one optical window that is positioned within the balloon interior 146);
wherein the source beam (124A) is directed through the beam guide (122A) from a guide proximal end (122P) to a guide distal end (122D) that is positioned within the balloon interior (see Cook Fig. 1; guide distal end 122D positioned inside balloon 104);
wherein the balloon (104) is configured to receive and retain a catheter fluid (132) within the balloon interior (146); and
wherein the source beam being directed into the balloon interior (146) induces generation of a plasma in the catheter fluid within the balloon interior (see Cook [0037]; light source 124 provides light pulses along light guides 122A to a location within the balloon interior 146 thereby inducing plasma formation in the balloon fluid 132).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system having an illumination assembly with an energy source that generates a source beam to induce the generation of a plasma in the catheter fluid within the balloon interior as taught by Cook. One of ordinary skill in the art would have been motivated to make this modification in order to utilize the generated plasma to induce a pressure wave which can be quantified by an optical analysis unit (Cook [0004-0008]).
Regarding claim 12, Carlin and/or Carlin in view of Cook teach the catheter system of claim 7.
Carlin further teaches the catheter system (30) comprising an energy source (optical fiber 39) that generates a source beam that is directed into the balloon interior (see Carlin Fig. 4, [0058]; optical path of light 50 is emitted in an outward direction towards balloon interior/lumen, it can be appreciated that under its broadest reasonable interpretation, the light beam 50 emitted from optical emitting fibers 601-606 of optical probe 39 meets the limitation of ‘a source beam’);
and an energy guide that is separate from the beam guide (see Carlin [0050]; guide wire 32 includes one or more optical probes 39 which each optical probe containing one or more optical emitting fibers, it can be appreciated that a separate optical emitting fiber, for example fiber 601, may be considered to be the beam guide, and a second, separate optical emitting fiber, for example fiber 602, may be considered to be the energy guide);
wherein the source beam (50) is directed through the energy guide (optical emitting fiber 601-606) from a guide proximal end (guidewire 32) to a guide distal end that is positioned within the balloon interior (see Carlin Fig. 7; optical emitting fibers 601-606 disposed in optical probe 39 located within the interior of balloon 20),
wherein the balloon is configured to receive and retain a catheter fluid within the balloon interior (see Carlin [0012]; the balloon may be expanded or contracted by fluid or gas delivered through the catheter).
Carlin is silent regarding wherein the source beam being directed into the balloon interior induces generation of a plasma in the catheter fluid within the balloon interior.
Cook teaches an energy source (light source 124) that generates a source beam (124A) that is directed into the balloon interior (see Cook [0048]; guide light to the guide distal end 122D having at least one optical window that is positioned within the balloon interior 146); and
an energy guide that is separate from the beam guide (see Cook [0036-0038]; the system comprises one or more light guides 122A where a first light guide 122A may be considered to be the beam guide and a second light guide 122A may be considered to be the energy guide);
wherein the source beam (124A) is directed through the energy guide (122A) from a guide proximal end (122P) to a guide distal end (122D) that is positioned within the balloon interior (see Cook Fig. 1; guide distal end 122D positioned inside balloon 104);
wherein the balloon (104) is configured to receive and retain a catheter fluid (132) within the balloon interior (146); and
wherein the source beam being directed into the balloon interior (146) induces generation of a plasma in the catheter fluid within the balloon interior (see Cook [0037]; light source 124 provides light pulses along light guides 122A to a location within the balloon interior 146 thereby inducing plasma formation in the balloon fluid 132).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system having an illumination assembly with an energy source that generates a source beam to induce the generation of a plasma in the catheter fluid within the balloon interior as taught by Cook. One of ordinary skill in the art would have been motivated to make this modification in order to utilize the generated plasma to induce a pressure wave which can be quantified by an optical analysis unit (Cook [0004-0008]).
Regarding claim 13, Carlin teaches the catheter system of claim 8 wherein the control detector assembly includes a photodetector (see Carlin [0015]; the detector may receive optical radiation transmitted through the plurality of optical emitting fibers);
wherein the photodetector generates a signal based at least in part on the portion of the returning energy that is directed to the photodetector (see Carlin [0015]; the processor may be in communication with the detector),
the signal being used by control electronics to determine the contact condition between the balloon wall and the vessel wall (see Carlin [0015]; the processor may control delivery of expansion gas or fluid to the balloon based on processing of the optical radiation signals provided by the plurality of optical emitting fibers).
Carlin is silent regarding the contact detector assembly including a beam splitter, the beamsplitter being configured to receive returning energy that has moved through the beam guide in the second direction from the guide distal end to the guide proximal end, and direct at least a portion of the returning energy to the photodetector.
Cook teaches an optical analyzer assembly (242) which includes a beamsplitter (266) and a photodetector (270),
the beamsplitter (266) being configured to receive returning energy that has moved through the beam guide (122A) in the second direction (121S) from the guide distal end (122D) to the guide proximal end (122P), and
direct at least a portion of the returning energy to the photodetector (see Cook [0085]; the beamsplitter 266 is configured to pass light having a wavelength longer than those visible to the photodetector 270); and
wherein the photodetector generates a signal based at least in part on the portion of the returning energy that is directed to the photodetector (see [0085-0086]; photodetector 270 generates a signal based on the visible light that has been collected by the photodetector),
the signal being used by control electronics (278) to determine the intensity of an event that occurred in the balloon interior (see Cook [0086]; the amplified signal from the photodetector is utilized within the control electronics 278 to determine the intensity of a plasma event that occurred in the balloon fluid 132 within the balloon interior 146).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system having a contact detector assembly which analyzes a beam returning through a beam guide in a second direction after coming in contact with an adjacent wall with the beamsplitter as taught by Cook. One of ordinary skill in the art would have been motivated to make this modification in order to selectively transmit a portion of light with respect to a threshold value to the photodetector and analysis assembly so that the resulting signal may be based on only the desired portion of the returning beam (Cook [0010]).
Claim(s) 10 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlin et al (US 20080077225 A1) in view of Stern (US 20140330133 A1).
Regarding claim 10, Carlin teaches the catheter system of claim 10. Carlin is silent regarding wherein the first assembly illumination beam is at a first wavelength; and
wherein the second assembly illumination beam is at a second wavelength that is different than the first wavelength.
Stern teaches a catheter system (10) comprising a balloon (28) and a first and second illumination assembly source (20) wherein the first assembly illumination beam is at a first wavelength; and wherein the second assembly illumination beam is at a second wavelength that is different than the first wavelength (see Stern [0028-0030]; the projected light may comprise two or more different wavelengths).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with a first and second illumination assembly having different wavelengths. One of ordinary skill in the art would have been motivated to make this modification in order to simultaneously analyze different properties specific to each of the wavelengths (Stern [0030]).
Regarding claim 19, Carlin teaches the method of claim 18 wherein the step of moving the first assembly illumination beam (50) includes
moving the first assembly illumination beam in the first direction through a beam guide see [0054]; optical emitting fibers includes hollow air-filled tubes with reflecting inner walls, which are considered to be a beam guide) from a guide proximal end to a guide distal end (see [0053]; optical probe contains multiple optical emitting fibers each of which terminate in an optical head that deflects and possibly shapes the emitted optical radiation pattern, the optical head considered to be located at the distal end) that is positioned within the balloon interior (see Fig. 7; optical emitting fibers 601-606 disposed in optical probe 39 located within the interior of balloon 20),
the first assembly illumination beam including first light energy that is at a first wavelength (see [0018]; the optical radiation may be low coherence light or light of any wavelength suitable);
wherein the step of moving the first returning energy beam includes moving the first returning energy beam in the second direction through the beam guide from the guide distal end to the guide proximal end (see [0057]; the optical emitting fibers within the optical probe 39 receive light scattered back from structures which may include the balloon wall or vessel lumen),
the first returning energy beam including second light energy from at least a portion of the first light energy being reflected from the vessel wall (see Figs. 4 and 5 illustrating plots of light energy reflected back from structures outside the optical probe which may include the vessel wall);
wherein the step of moving the second assembly illumination beam (50) through the beam guide (see [0054]; optical emitting fibers includes hollow air-filled tubes with reflecting inner walls, which are considered to be a beam guide) from the guide proximal end to the guide distal end (see [0053]; optical probe contains multiple optical emitting fibers each of which terminate in an optical head that deflects and possibly shapes the emitted optical radiation pattern, where the optical head is considered to be located at the distal end) that is positioned within the balloon interior (see Fig. 7; optical emitting fibers 601-606 disposed in optical probe 39 located within the interior of balloon 20),
wherein the step of moving the second returning energy beam includes moving the second returning energy beam through the beam guide from the guide distal end to the guide proximal end (see [0048]; the LCI backscattered signal may be used to determine the linear distance between the optical emitting fiber, a stent disposed on a balloon, and the lumen wall, [0073]; Fig. 8 showing measurement of the radial distances for each of the optical emitting fibers),
the second returning energy beam including second light energy from at least a portion of the first light energy from the second assembly illumination beam being reflected from blood that is positioned between the balloon wall and the vessel wall (see [0066]; LCI signal would derive primarily only from the scattering from blood 12, and the refractive index of blood would be use to determine distances between the balloon wall and arterial tissue).
Carlin is silent regarding the second assembly illumination beam including first light energy that is at a second wavelength that is different than the first wavelength.
Stern teaches a catheter system (10) comprising a balloon (28) and a first and second illumination assembly source (20) wherein the first assembly illumination beam is at a first wavelength; and wherein the second assembly illumination beam is at a second wavelength that is different than the first wavelength (see Stern [0028-0030]; the projected light may comprise two or more different wavelengths).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with a first and second illumination assembly having different wavelengths. One of ordinary skill in the art would have been motivated to make this modification in order to simultaneously analyze different properties specific to each of the wavelengths (Stern [0030]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carlin et al (US 20080077225 A1) in view of Zhai et al (US 20230027712 A1) and Stern (US 20140330133 A1).
Regarding claim 20, Carlin teaches a catheter system for treating a treatment site within or adjacent to a vessel wall of a blood vessel, the catheter system (30) comprising:
a balloon (20) that is positionable substantially adjacent to the vessel wall at the treatment site (see [0022]; stent delivery system into a body cavity or vessel lumen comprising a catheter having a balloon disposed over the distal portion of the catheter),
the balloon (20) having a balloon wall (inner balloon wall 40) that defines a balloon interior;
the balloon being configured to receive and retain a catheter fluid within the balloon interior (see Carlin [0050]; balloon may be inflatable through the catheter with an inflation fluid such as saline);
a beam guide (see [0054]; optical emitting fibers includes hollow air-filled tubes with reflecting inner walls, which are considered to be a beam guide) including a guide proximal end and a guide distal end (see [0053]; optical probe contains multiple optical emitting fibers each of which terminate in an optical head that deflects and possibly shapes the emitted optical radiation pattern, the optical head considered to be located at the distal end) that is positioned within the balloon interior (see Fig. 7; optical emitting fibers 601-606 disposed in optical probe 39 located within the interior of balloon 20),
a first assembly illumination source (one of optical emitting fibers 601-606 of optical probe 39) that generates a first assembly illumination beam (50) that moves through the beam guide in a first direction from the guide proximal end to the guide distal end (see Fig. 4, [0058]; optical path of light 50 is emitted in an outward direction towards balloon interior/lumen),
the first assembly illumination beam including first light energy that is at a first wavelength (see [0018]; the optical radiation may be low coherence light or light of any wavelength suitable),
the first assembly illumination beam being directed from the guide distal end toward the vessel wall (see Fig. 7),
a second assembly illumination source that generates a second assembly illumination beam (50) that moves in the first direction through the beam guide (see [0054]; optical emitting fibers includes hollow air-filled tubes with reflecting inner walls, which are considered to be a beam guide) from the guide proximal end to the guide distal end (see [0053]; optical probe contains multiple optical emitting fibers each of which terminate in an optical head that deflects and possibly shapes the emitted optical radiation pattern, where the optical head is considered to be located at the distal end)
the second assembly illumination beam being directed from the guide distal end toward the vessel wall (see Fig. 7);
a contact detector assembly that is configured to optically analyze (see [0015]; processor may be in communication with detector)
(i) a first returning energy beam from the balloon interior that moves through the beam guide in a second direction from the guide distal end to the guide proximal end, the first returning energy beam including second light energy from at least a portion of the first light energy being reflected from the vessel wall (see [0069]; the physical distance from any interface j to any interface k, where the interfaces are any of the interfaces labeled 1-6 in Fig. 4, along the light-path of the mth optical emitting fiber can be designated from one another, Fig. 6 shows a representation of the optical path lengths that demonstrates the balloon fully expanded to the artery wall when the LCI trace W from the balloon wall nearly overlaps the trace A of the artery wall), and
(ii) a second returning energy beam from the balloon interior that moves through the beam guide in the second direction from the guide distal end to the guide proximal end, the second returning energy beam including second light energy from at least a portion of the first light energy from the second assembly illumination beam being reflected from blood that is positioned between the balloon wall and the vessel wall (see [0069], Fig. 4 showing blood 12)
the contact detector assembly being configured to analyze the first returning energy beam and the second returning energy beam to determine a contact condition between the balloon wall and the vessel wall (see [0069]; the physical distance from any interface j to any interface k, where the interfaces are any of the interfaces labeled 1-6 in Fig. 4, along the light-path of the mth optical emitting fiber can be designated from one another, Fig. 6 shows a representation of the optical path lengths that demonstrates the balloon fully expanded to the artery wall when the LCI trace W from the balloon wall nearly overlaps the trace A of the artery wall).
Carlin is silent regarding a pressure sensor assembly including a pressure sensor that is configured to sense an internal balloon pressure of the catheter fluid within the balloon interior,
the pressure sensor being in fluid communication with the catheter fluid retained within the balloon interior;
a balloon compliance chart that plots an outer diameter of the balloon versus the internal balloon pressure;
a balloon diameter determination system that determines the outer diameter of the balloon based on the sensed internal balloon pressure and the balloon compliance chart,
the second assembly illumination beam including first light energy that is at a second wavelength that is different than the first wavelength,
a vessel diameter determination system that is configured to determine an inner diameter of the blood vessel;
wherein when the contact detector assembly determines that good contact exists between the balloon wall and the vessel wall,
the vessel diameter determination system determines that the inner diameter of the blood vessel is equal to the outer diameter of the balloon,
the vessel diameter determination system being configured to determine the inner diameter of the blood vessel at multiple locations along the site length of the treatment site;
a system controller including one or more processors; and
a diameter correlation system that is at least partially integrated within the system controller,
the diameter correlation system being configured to utilize data from the balloon diameter determination system regarding the outer diameter of the balloon, and data from the vessel diameter determination system regarding the inner diameter of the blood vessel at the multiple locations along the site length of the treatment site,
for purposes of ensuring a proper correlation of the outer diameter of the balloon and the inner diameter of the blood vessel during use of the catheter system in a therapeutic procedure.
Zhai teaches a catheter system (102) comprising a balloon (112) that is positionable substantially adjacent to the vessel wall at a treatment site wherein the balloon is configured to receive and retain a catheter fluid within the balloon interior (see Zhai [0011]; filling a balloon within a body lumen with a fluid); and
wherein the catheter system (102) further comprises a pressure sensor assembly (cartridge 130) including
a pressure sensor (pressure sensor P1, P2, and/or P3) that is configured to sense an internal balloon pressure of the catheter fluid within the balloon interior (see Zhai [0097]; one or more pressure sensors P1, P2, and P3 can be used to monitor the pressure in the balloon 112),
the pressure sensor being in fluid communication with the catheter fluid retained within the balloon interior (see Zhai [0099]; pressure sensors P1, P2, and P3 can be used to monitor the fluidic pressure at various points along the fluidic paths which can be provided to the controller 120 for purposes such as monitoring the fluidic pressure within the balloon 112)
a balloon compliance chart that plots an outer diameter of the balloon versus the internal balloon pressure (see Zhai Fig. 18), and
a balloon diameter determination system that determines the outer diameter of the balloon based on the sensed internal balloon pressure and the balloon compliance chart (see Zhai [0067]; balloon 112 is a compliant balloon configured to inflate between a first diameter and a second diameter using an inflation pressure between a first inflation pressure and a second inflation pressure such that the outer diameter is directly correlated with the pressure of the balloon 112).
a vessel diameter determination system that is configured to determine an inner diameter of the blood vessel (see Zhai [0010-0011]; a system to determine the size of a body lumen based on a comparison to a parameter curve);
wherein the vessel diameter determination system determines that the inner diameter of the blood vessel is equal to the outer diameter of the balloon (see Zhai Fig. 19B, [0231-0233]; the size of the body lumen is determined based on the comparison between the parameter curve 20004 and the reference curve 2002) when the balloon is determined to be in contact with the vessel wall (see Zhai [0233]; the body lumen size can be determined using a comparison between inflection points, [0370]; estimate a size of a portion of a body lumen based on sensor measurements taken between time t1, when a balloon is sufficiently inflated such that the pressure is at least that of an environmental pressure and time t2 when the balloon becomes in apposition with the portion of the body lumen).
the vessel diameter determination system being configured to determine the inner diameter of the blood vessel at multiple locations along the site length of the treatment site (see Zhai Fig. 17, [0219]; the controller 120 may use the diameter measurement determined at step 1720, which may be based on pressure sensor measurements at step 1714, to determine if the balloon should be deflated and moved and the diameter determination at step 1714/1716/1817 should be repeated),
a system controller (120) including one or more processors (612); and
a diameter correlation system that is at least partially integrated within the system controller (see Zhai [0102]; processor 612 can use sensor measurements from one or more of the pressure sensors to estimate an inner diameter of a body lumen); and
wherein the diameter correlation system is configured to utilize data from the balloon diameter determination system regarding the outer diameter of the balloon (see Zhai [0067]; balloon 112 is a compliant balloon configured to inflate between a first diameter and a second diameter using an inflation pressure between a first inflation pressure and a second inflation pressure such that the outer diameter is directly correlated with the pressure of the balloon 112), and
data from the vessel diameter determination system regarding the inner diameter of the blood vessel at the multiple locations along the site length of the treatment site (see Zhai Fig. 17, [0219]; the controller 120 may use the diameter measurement determined at step 1720, which may be based on pressure sensor measurements at step 1714, to determine if the balloon should be deflated and moved and the diameter determination at step 1714/1716/1817 should be repeated),
for purposes of ensuring a proper correlation of the outer diameter of the balloon and the inner diameter of the blood vessel during use of the catheter system in a therapeutic procedure (see Zhai [0102]; using sensor measurements from the one or more pressure sensors to determine when the balloon 112 is in apposition with a body lumen as well as to estimate an inner diameter of the body lumen).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with the diameter correlation system as taught by Zhai. One of ordinary skill in the art would have been motivated to make this modification in order to determine the appropriate dose of energy for a therapeutic treatment to be applied to a vessel based on the size of the body lumen (Zhai [0104]).
Stern teaches a catheter system (10) comprising a balloon (28) and a first and second illumination assembly source (20) wherein the first assembly illumination beam is at a first wavelength; and wherein the second assembly illumination beam is at a second wavelength that is different than the first wavelength (see Stern [0028-0030]; the projected light may comprise two or more different wavelengths).
It would have been obvious for one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify Carlin’s catheter system with a first and second illumination assembly having different wavelengths. One of ordinary skill in the art would have been motivated to make this modification in order to simultaneously analyze different properties specific to each of the wavelengths (Stern [0030]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISHA J SIRCAR whose telephone number is (571)272-0450. The examiner can normally be reached Monday - Thursday 9-6:30, Friday 9-5:30 CT.
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/A.J.S./Examiner, Art Unit 3792
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792