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 .
Remarks
This action is in response to the remarks filed 04/17/2026.
Claims 1-12, 15-18, and 21-24 are pending.
Response to Arguments
Applicant’s arguments, see pages 7-10, filed 04/17/2026, with respect to the rejection of claims 1-13, 15-18, and 21-23 under 35 U.S.C. 103 have been fully considered and are persuasive. Independent claims 1, 21, and 23 have been amended to recite the multiplexer including a multi-channel switch and “wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy”. New claim 24 has been added. Applicant argues that Kittrell or Kittrell in view of Grace fails to disclose the amended limitations. Examiner agrees. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground of rejection is made, as explained in the office action below. New claim 24 is rejected as explained in the office action below.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 24 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recites the limitation of “a second beam splitter linearly aligned with and downstream of the first optical valve”. The limitation of the second beam splitter being linearly aligned with and downstream of the first optical valve is not described in the specification.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-12, 15, 17, 18, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Kittrell et al. (US Patent Application Publication 2002/0045811 – of record), hereinafter Kittrell, further in view of Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace, and further in view of Verhagen et al. (US Patent Application Publication 2010/0063491 – of record), hereinafter Verhagen.
Regarding claim 1, Kittrell discloses a catheter system for treating a vascular lesion within or adjacent to a vessel wall within a body of a patient (e.g. Abstract), the catheter system including a single light source that generates light energy (e.g. Fig. 19, 20: laser 92), the catheter system comprising:
a first light guide and a second light guide that are each configured to selectively receive light energy from the light source (e.g. Fig. 19, 20: optical fibers 20 that receive the laser energy from input ends 40; Par. [0106]); and
a multiplexer that receives the light energy from the light source and selectively directs the light energy to each of the first light guide and the second light guide (e.g. Fig. 19: translator 200 is considered the multiplexer; Par. [0106]), the multiplexer including a multi-channel switch comprising a system of optical valves arranged in a linear sequence within the multiplexer (e.g. Fig. 19: multiplexer 200 in linear sequence with half-wave plate and polarizer 47, shutter 44, deflector 49, and lens 41; Fig. 19, 20: light energy is divided into the multiple optical fibers 20; Pars. [0112]-[0114]: describing Fig. 19; Instant claim 3 describes the optical valves as including a half-wave plate.), and
a multi-guide ferrule that organizes the first light guide and the second light guide in a linear pattern (e.g. Fig. 19, 20: optical fiber housing 46 organizes the fibers in a linear array).
However, Kittrell fails to disclose wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide and wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy. Grace, in a similar field of endeavor, is directed towards a laser induced fluid filled balloon catheter. Grace discloses wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide (e.g. Par. [0284]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell to include creating the plasma as taught by Grace because doing so would result in creating pressure waves that disrupt vascular obstructions (e.g. Grace, par. [0284]).
However, Kittrell in view of Grace fails to disclose wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy. Verhagen is directed towards a device for imaging a skin object. Verhagen discloses using a polarizing beam splitter cube to reflect and transmit different polarization components differently (e.g. Par. [0019]; Instant claim 16 states that the multi-channel switch can be a polarizing beam splitter cube.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell in view of Grace to include the beam splitting as taught by Verhagen because doing so would provide the results of reflecting and transmitting different polarization components (e.g. Verhagen, par. [0019]).
Regarding claim 2, Kittrell further discloses wherein the multi-channel switch includes a polarizing beam splitter (e.g. Par. [0117]: beam splitter 52 may be of the polarizing type).
Regarding claim 3, Kittrell further discloses wherein the system of optical valves comprises an optical valve including a half-wave plate (e.g. Par. [0112]).
Regarding claim 4, Kittrell further discloses wherein the half-wave plate is configured to rotate between 0 and 90 degrees (e.g. Par. [0112]).
Regarding claim 5, Kittrell further discloses wherein the half-wave plate can vary energy levels transmitted through the half-wave plate based on a rotation angle of the half-wave plate (e.g. Par. [0112]).
Regarding claim 6, Kittrell further discloses wherein the system of optical valves includes a rotational member that rotates the half-wave plate (e.g. Pars. [0112]-[0113]: half-wave plate is rotated, a rotary stage is used).
Regarding claim 7, Kittrell further discloses wherein the rotational member is a rotation stage (e.g. Pars. [0112]-[0113]: half-wave plate is rotated, a rotary stage is used).
Regarding claim 8, Kittrell further discloses wherein the rotational member is configured to control a half-wave plate orientation so that the light energy is directed into selected light guides (e.g. Fig. 19: the light energy is provided to different optical fibers 20; Pars. [0112]-[0113]).
Regarding claim 9, Kittrell further discloses a controller that (i) triggers the light source to emit the light energy (e.g. Par. [0113]: shutter which is controlled by the computer turns the laser on/off), and (ii) sets the half-wave plate orientation (e.g. Par. [0112]: shutter and half-wave plate controlled by the computer).
Regarding claim 10, Kittrell further discloses wherein the system of optical valves includes an individual valve that receives the light energy from the light source and directs the light energy from the light source into an optical channel based on at least one of (i) a polarization state of the light energy, and (ii) the orientation of a fast axis of a half- wave plate (e.g. Fig. 19: shutter 44 and component 47 receive the light energy and direct it to the optical fibers; Par. [0112]: half-wave plate is rotated).
Regarding claim 11, Kittrell further discloses wherein the individual valve has a single rotational degree of freedom (e.g. Fig. 19: half-wave plate 47 rotates the polarization; Pars. [0112]-[0113]).
Regarding claim 12, Kittrell further discloses wherein the system of optical valves includes a plurality of valves each having a single rotational degree of freedom (e.g. Fig. 19: half-wave plate 47 rotates the polarization; Pars. [0112]-[0113]).
Regarding claim 15, Kittrell further discloses wherein the multi-guide ferrule is a ferrule block (e.g. Fig. 19, 20: optical fiber housing 46 organizes the fibers in a linear array). Kittrell discloses the claimed invention but does not disclose expressly the v-groove ferrule block. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the invention as taught by Kittrell with the v-groove ferrule block, because Applicant has not disclosed that v-groove ferrule block provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the optical fiber housing as taught by Kittrell, because it provides the predictable results of organizing the optical fibers to receive the light energy and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Kittrell. Therefore, it would have been an obvious matter of design choice to modify Kittrell to obtain the invention as specified in the claim.
Regarding claim 16, Kittrell fails to specifically disclose wherein the multi-channel switch includes a polarizing beam splitter cube. Verhagen is directed towards a device for imaging a skin object. Verhagen discloses using a polarizing beam splitter cube to reflect and transmit different polarization components differently (e.g. Par. [0019]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell in view of Grace and Verhagen to include the polarizing beam splitter cube as taught by Verhagen because doing so would provide the results of reflecting and transmitting different polarization components (e.g. Verhagen, par. [0019]).
Regarding claim 17, Kittrell further discloses a coupling optics system including a reflector and a lens, the coupling optics system receives the light energy output by the system of optical valves, redirects the light energy using the reflector, and focuses the light energy into the first light guide and the second light guide using the lens (e.g. Fig. 19: lens 42 directs the energy into the optical fibers; Fig. 20: mirror 48 reflects the light energy from the lens 41’).
Regarding claim 18, Kittrell further discloses multi-guide ferrule that organizes a plurality of light guides into one of (i) a circular pattern, (ii) a hexagonal packed pattern, (iii) a symmetrical pattern, (iv) a non-symmetrical pattern, and (v) a two-dimension grid array (e.g. Fig. 19, 20: optical fiber housing 46 organizes the fibers in a linear, symmetrical array; Fig. 12b: circular pattern of the optical fibers 20).
Regarding claim 21, Kittrell discloses a catheter system for treating a vascular lesion within or adjacent to a vessel wall within a body of a patient (e.g. Abstract), the catheter system including a single light source that generates light energy (e.g. Fig. 19, 20: laser 92), the catheter system comprising: a first light guide and a second light guide that are each configured to selectively receive light energy from the light source (e.g. Fig. 19, 20: optical fibers 20 that receive the laser energy from input ends 40; Par. [0106]); and a multiplexer that receives the light energy from the light source and selectively directs the light energy to each of the first light guide and the second light guide (e.g. Fig. 19: translator 200 is considered the multiplexer; Par. [0106]), the multiplexer including a multi-channel switch comprising a system of optical valves arranged in a linear sequence within the multiplexer (e.g. Fig. 19: multiplexer 200 in linear sequence with half-wave plate and polarizer 47, shutter 44, deflector 49, and lens 41; Fig. 19, 20: light energy is divided into the multiple optical fibers 20; Pars. [0112]-[0114]: describing Fig. 19; Instant claim 3 describes the optical valves as including a half-wave plate.), and a catheter shaft (e.g. Par. [0061]: catheter body 16).
However, Kittrell fails to disclose a balloon that is coupled to the catheter shaft, the balloon including a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; wherein the first light guide and the second light guide are positioned at least partially within the balloon interior, the balloon including a drug eluting coating, wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide, and wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy.
Grace, in a similar field of endeavor, is directed towards a laser induced fluid filled balloon catheter. Grace discloses a balloon that is coupled to the catheter shaft, the balloon including a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior (e.g. Fig. 2: balloon catheter can be seen with a balloon wall that defines a balloon interior; Fig. 5: step 540: inflate the balloon with liquid medium; Par. [0274]), wherein the first light guide and the second light guide are positioned at least partially within the balloon interior (e.g. Pars. [0361] – [0362]: distal end of the catheter includes light emitters; Figs. 12, 12A: light emitters 115 located inside balloon), the balloon including a drug eluting coating (Par. [0031]: the balloon is coated with one or more therapeutic agents), and wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide (e.g. Par. [0284]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell to include a balloon coupled to the catheter as taught by Grace because doing so would result in creating pressure waves that disrupt vascular obstructions (e.g. Grace, par. [0284]).
However, Kittrell in view of Grace fails to disclose wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy. Verhagen is directed towards a device for imaging a skin object. Verhagen discloses using a polarizing beam splitter cube to reflect and transmit different polarization components differently (e.g. Par. [0019]; Instant claim 16 states that the multi-channel switch can be a polarizing beam splitter cube.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell in view of Grace to include the beam splitting as taught by Verhagen because doing so would provide the results of reflecting and transmitting different polarization components (e.g. Verhagen, par. [0019]).
Regarding claim 22, Kittrell further discloses a multi-guide ferrule that organizes the first light guide and the second light guide in a linear pattern (e.g. Fig. 19, 20: optical fiber housing 46 organizes the fibers in a linear array).
Regarding claim 24, Kittrell fails to disclose wherein the system of optical valves comprise a first optical valve and a first beam splitter configured to selectively direct the first light energy into the first light guide and a second optical valve and a second beam splitter linearly aligned with and downstream of the first optical valve, the second optical valve configured to selectively direct the second light energy into the second light guide. Verhagen is directed towards a device for imaging a skin object. Verhagen discloses a first optical valve and a first beam splitter configured to selectively direct the first light energy and a second optical valve and a second beam splitter linearly aligned with and downstream of the first optical valve, the second optical valve configured to selectively direct the second light energy (e.g. Fig. 1, 2: light goes from source 1 to first beam splitter 2 where it is sent to detector 8 and to second beam splitter 3; Pars. [0039]-[0040]: describing Fig. 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell in view of Grace and Verhagen to include selectively directing energy as taught by Verhagen, because doing so would allow the transmission of the light energy to the appropriate components.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Kittrell et al. (US Patent Application Publication 2002/0045811 – of record), hereinafter Kittrell, further in view of Verhagen et al. (US Patent Application Publication 2010/0063491 – of record), hereinafter Verhagen, and further in view of Grace et al. (US Patent Application Publication 2017/0265942 – of record), hereinafter Grace.
Regarding claim 23, Kittrell discloses a catheter system for treating a vascular lesion within or adjacent to a vessel wall within a body of a patient (e.g. Abstract), the catheter system including a single light source that generates light energy (e.g. Fig. 19, 20: laser 92), the catheter system comprising: a first light guide and a second light guide that are each configured to selectively receive light energy from the light source (e.g. Fig. 19, 20: optical fibers 20 that receive the laser energy from input ends 40; Par. [0106]); and a multiplexer that receives the light energy from the light source and selectively directs the light energy to each of the first light guide and the second light guide (e.g. Fig. 19: translator 200 is considered the multiplexer; Par. [0106]), the multiplexer including a multi-channel switch comprising a system of optical valves (e.g. Fig. 19: multiplexer 200 in linear sequence with half-wave plate and polarizer 47, shutter 44, deflector 49, and lens 41; Fig. 19, 20: light energy is divided into the multiple optical fibers 20; Pars. [0112]-[0114]: describing Fig. 19; Instant claim 3 describes the optical valves as including a half-wave plate.), and a multi-guide ferrule that organizes the first light guide and the second light guide in a linear pattern (e.g. Fig. 19, 20: optical fiber housing 46 organizes the fibers in a linear array), and a catheter shaft (e.g. Par. [0061]: catheter body 16).
However, Kittrell fails to disclose wherein the polarizing beam splitter is a polarizing beam splitter cube, wherein the multi-guide ferrule block includes a v-groove ferrule block, and a balloon that is coupled to the catheter shaft, the balloon including a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; wherein the first light guide and the second light guide are positioned at least partially within the balloon interior, and wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide, and wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy.
Kittrell further discloses wherein the multi-guide ferrule is a ferrule block (e.g. Fig. 19, 20: optical fiber housing 46 organizes the fibers in a linear array). Kittrell discloses the claimed invention but does not disclose expressly the v-groove ferrule block. It would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the invention as taught by Kittrell with the v-groove ferrule block, because Applicant has not disclosed that v-groove ferrule block provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with the optical fiber housing as taught by Kittrell, because it provides the predictable results of organizing the optical fibers to receive the light energy and since it appears to be an arbitrary design consideration which fails to patentably distinguish over Kittrell. Therefore, it would have been an obvious matter of design choice to modify Kittrell to obtain the invention as specified in the claim.
However, Kittrell further fails to disclose wherein the polarizing beam splitter is a polarizing beam splitter cube and a balloon that is coupled to the catheter shaft, the balloon including a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; wherein the first light guide and the second light guide are positioned at least partially within the balloon interior, and wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide, and wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy.
Verhagen is directed towards a device for imaging a skin object. Verhagen discloses using a polarizing beam splitter cube to reflect and transmit different polarization components differently, wherein the multi-channel switch being configured to divide the light energy into a first light energy and a second light energy (e.g. Par. [0019]; Instant claim 16 states that the multi-channel switch can be a polarizing beam splitter cube.).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell to include the polarizing beam splitter cube as taught by Verhagen to provide the results of reflecting and transmitting different polarization components (e.g. Verhagen, par. [0019]).
However, Kittrell in view of Verhagen fails to disclose a balloon that is coupled to the catheter shaft, the balloon including a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior; wherein the first light guide and the second light guide are positioned at least partially within the balloon interior, and wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide.
Grace, in a similar field of endeavor, is directed towards a laser induced fluid filled balloon catheter. Grace discloses a balloon that is coupled to the catheter shaft, the balloon including a balloon wall that defines a balloon interior, the balloon being configured to retain a balloon fluid within the balloon interior (e.g. Fig. 2: balloon catheter can be seen with a balloon wall that defines a balloon interior; Fig. 5: step 540: inflate the balloon with liquid medium; Par. [0274]), wherein the first light guide and the second light guide are positioned at least partially within the balloon interior (e.g. Pars. [0361] – [0362]: distal end of the catheter includes light emitters; Figs. 12, 12A: light emitters 115 located inside balloon), and wherein the light energy is configured to create a plasma near a distal end of the first light guide, the second light guide, or both the first light guide and the second light guide (e.g. Par. [0284]).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Kittrell in view of Verhagen to include a balloon coupled to the catheter as taught by Grace because doing so would result in creating pressure waves that disrupt vascular obstructions (e.g. Grace, par. [0284]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Zhou (US Patent Application Publication 2006/0241572) is directed towards an image guided laser catheter. Zhou discloses a multi-channel switch configured to divide the light energy into a first and second light energy (e.g. Pars. [0056], [0058]: the output from the laser is split into two light beams, “The output from laser 87 is split by beam splitters 123, 124 into light beams 67, 121.”).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHREYA P ANJARIA whose telephone number is (571)272-9083. The examiner can normally be reached M-F: 8:00-5:00 EST.
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/SHREYA ANJARIA/Examiner, Art Unit 3796
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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