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 .
Response to Arguments
Applicant’s arguments, see Appeal Brief, filed 01/16/2026, with respect to the rejection of claims 1-20 under 35 U.S.C. 112(a) and 35 U.S.C. 103 have been fully considered and are persuasive.
Regarding the rejection of the claims under 35 U.S.C. 103, Applicant argues (see Brief, pages 13-15) that Hennings or Hennings in view of Hu does not disclose the limitation of the optical energy with a wavelength no more than 800nm. Examiner agrees. Therefore, the rejection has been withdrawn. However, Hennings is still eligible as prior art. The argument (pages 14-15) that Hennings teaches away from the claimed invention is not persuasive. While Hennings discloses an embodiment that uses wavelengths in the ranges of 1.3-1.8nm and 1.9-2.2nm, it also discloses a wider range of wavelengths (e.g. Pars. [0035], [0042]: laser energy source with wavelengths between 300-1200nm). As explained in MPEP 2123, non-preferred embodiments still constitute prior art. Therefore, Hennings is still eligible as prior art. Upon further consideration, a new ground of rejection is made, as explained in the office action below.
Regarding the rejection of the claims under 35 U.S.C. 112(a), Applicant argues (see Brief, pages 16-17) that par. [0029] of the instant specification provides support for the claimed limitation of the energy source “having a wavelength no more than 800 nanometers”. Examiner agrees. Therefore, the rejection has been withdrawn.
In view of the Appeal Brief filed on 01/16/2026, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
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Remarks
This action is in response to the Appeal Brief filed 01/16/2026.
Claims 1-20 are pending.
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, 2, 6, 8, 9, 11, 13-17, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Unser et al. (US Patent Application Publication 2014/0236118), hereinafter Unser, in view of Yang et al. (US Patent Application Publication 2017/0312552 – of record), hereinafter Yang.
Regarding claim 1, Unser discloses a system for removing blood clots (e.g. Abstract), the system comprising:
an optical energy source for generating an optical energy (e.g. Par. [0102]: laser ablation performed);
an ultrasound transducer focused at a target location (e.g. Par. [0061]: ultrasound and light can be combined to identify blood clots invasively or noninvasively; Par. [0082]: ultrasonic energy can be used to ablate the thrombus); and
an optical conduit for insertion into a vessel, wherein the optical conduit is configured to direct the optical energy from the optical energy from a terminal end of the optical conduit to the target location in the vessel (e.g. Par. [0102]: laser ablation performed through optical fibers).
However, Unser fails to specifically disclose the optical energy source having a wavelength no more than 800 nanometers.
Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses an optical energy source that can have a wavelength with an upper value of 800nm (e.g. Par. [0036]: the peak wavelength can have an upper value of 800nm, “the peak wavelength may be in a range having an upper value, a lower value, or an upper and lower value including any of 400 nm, 600 nm, 800 nm, 1000 nm, 1200 nm, 1400 nm, 1600 nm, 1800 nm, 2000 nm, 2200 nm, 2400 nm, or any values therebetween”; Pars. [0055]-[0056]: optical energy with a wavelength of 570nm; Par. [0061]: wavelength can be between 500nm and 600nm).
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 Unser to include the optical energy source having a wavelength of no more than 800nm as taught by Yang because doing so would allow the wavelength to be tuned to the peak optical absorption wavelength of the target material, such as hemoglobin (e.g. Yang, par. [0036]).
Regarding claim 2, Unser further discloses where the ultrasound transducer is external to the vessel (e.g. Par. [0077]: ultrasound system outside of the vessel).
Regarding claim 6, Unser discloses a method comprising:
transmitting an acoustic energy burst into a tissue space (e.g. Par. [0061]: ultrasound and light can be combined to identify blood clots invasively or noninvasively; Par. [0082]: ultrasonic energy can be used to ablate the thrombus);
providing a sequence of laser pulses through an optical conduit into a blood vessel within the tissue space (e.g. Par. [0102]: laser ablation performed through optical fibers); and
emitting the sequence of laser pulses from the optical conduit to a blood clot within the blood vessel (e.g. Par. [0011]; Par. [0102]: laser ablation performed through optical fibers).
However, Unser fails to disclose inducing cavitation, wherein the laser pulses have a wavelength of no more than 800 nanometers, and wherein at least one of the laser pulses of the sequence of laser pulses is synchronized with the acoustic energy burst.
Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses inducing cavitation (e.g. Abstract), wherein the laser pulses have a wavelength of no more than 800 nanometers (e.g. Par. [0036]: the peak wavelength can have an upper value of 800nm, “the peak wavelength may be in a range having an upper value, a lower value, or an upper and lower value including any of 400 nm, 600 nm, 800 nm, 1000 nm, 1200 nm, 1400 nm, 1600 nm, 1800 nm, 2000 nm, 2200 nm, 2400 nm, or any values therebetween”; Pars. [0055]-[0056]: optical energy with a wavelength of 570nm; Par. [0061]: wavelength can be between 500nm and 600nm), and wherein at least one of the laser pulses of the sequence of laser pulses is synchronized with the acoustic energy (e.g. Abstract; Par. [0009]: providing acoustic and optical energy concurrently to cause cavitation, “providing an optical energy to the target location concurrently with the acoustic energy… The combination of the pressure of the acoustic energy and the fluence of the optical energy causes cavitation in blood.”; Par. [0045]: laser pulse is delivers at the beginning of each ultrasound burst to overlay the rarefaction phase at the target location).
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 Unser to include inducing cavitation, wherein the laser pulses have a wavelength of no more than 800 nanometers, and wherein at least one of the laser pulses of the sequence of laser pulses is synchronized with the acoustic energy burst as taught by Yang because doing so would allow the wavelength to be tuned to the peak optical absorption wavelength of the target material, such as hemoglobin (e.g. Yang, par. [0036]).
Regarding claim 8, Unser fails to disclose wherein the acoustic energy burst has a pressure of about 1 MPa or less. Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses wherein the acoustic energy burst has a pressure of about 1 MPa or less (e.g. Par. [0046]: pressure can be 0.1-5MPa).
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 Unser in view of Yang to include the acoustic energy burst having a pressure of 1MPa or less as taught by Yang because doing so would allow precise targeting of the target location to provide treatment.
Regarding claim 9, Unser further discloses wherein the optical conduit is a fiber optic inserted into the blood vessel (e.g. Par. [0102]).
Regarding claim 11, Unser fails to disclose wherein a laser fluence of the laser pulses is between about 0.1 and 500 mJ/cm2. Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses wherein a laser fluence of the laser pulses is between about 0.1 and 500 mJ/cm2 (e.g. Par. [0041]: laser fluence between 1-100 mJ/cm2).
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 Unser in view of Yang to include the laser fluence of the laser pulses is between about 0.1 and 500 mJ/cm2as taught by Yang because doing so would allow precise targeting of the target location to provide treatment.
Regarding claim 13, Unser further discloses wherein the target is a blood clot (e.g. Abstract, Par. [0008]). However, Unser fails to disclose producing cavitation in the target at a confluence of the acoustic energy burst and the sequence of laser pulses to produce thermoelastic stress in the target based at least in part on the target absorbing optical energy from at least some of the sequence of laser pulses.
Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses producing cavitation in the target at a confluence of the acoustic energy burst and the sequence of laser pulses to produce thermoelastic stress in the target based at least in part on the target absorbing optical energy from at least some of the sequence of laser pulses (e.g. Abstract; Par. [0009]: providing acoustic and optical energy concurrently to cause cavitation, “providing an optical energy to the target location concurrently with the acoustic energy… The combination of the pressure of the acoustic energy and the fluence of the optical energy causes cavitation in blood.”; Par. [0045]: laser pulse is delivers at the beginning of each ultrasound burst to overlay the rarefaction phase at the target location).
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 Unser in view of Yang to include producing cavitation in the target as taught by Yang because doing so would allow effective removal of a blood clot.
Regarding claim 14, Unser fails to disclose producing the cavitation in the blood clot without introducing exogenous agents into the blood vessel. Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses producing the cavitation in the blood clot without introducing exogenous agents into the blood vessel (e.g. Par. [0027]).
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 Unser in view of Yang to include producing the cavitation in the blood clot without introducing exogenous agents into the blood vessel as taught by Yang because doing so would provide selective and precise treatment.
Regarding claim 15, Unser in view of Yang further discloses wherein the cavitation induces thrombolysis (e.g. Unser, Abstract; Par. [0008]).
Regarding claim 16, Unser fails to disclose wherein the acoustic energy burst has a pressure that is insufficient to cause cavitation alone. Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses wherein the acoustic energy burst has a pressure that is insufficient to cause cavitation alone (e.g. Par. [0009]).
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 Unser in view of Yang to include wherein the acoustic energy burst has a pressure that is insufficient to cause cavitation alone as taught by Yang because doing so would allow precise targeting of the target location to provide treatment.
Regarding claim 17, Unser discloses a method inducing thrombolysis (e.g. Abstract; Par. [0008]), the method comprising:
positioning an acoustic energy source outside of a patient's body and focused at a target location (e.g. Par. [0077]: ultrasound system outside of the vessel);
positioning an optical conduit inside a vessel of the patient's body (e.g. Par. [0102]);
transmitting an acoustic energy burst transcutaneously to the target location (e.g. Par. [0061]: ultrasound and light can be combined to identify blood clots invasively or noninvasively); and
providing a laser pulse through the optical conduit into the vessel to emit optical energy from the optical conduit to the target location (e.g. Par. [0102]).
However, Unser fails to disclose wherein the laser pulse has a wavelength no more than 800 nanometers, wherein the laser pulse is synchronized with a rarefaction phase of the acoustic enemy burst at the target location, and causing cavitation in the vessel.
Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses inducing cavitation (e.g. Abstract), wherein the laser pulses have a wavelength of no more than 800 nanometers (e.g. Par. [0036]: the peak wavelength can have an upper value of 800nm, “the peak wavelength may be in a range having an upper value, a lower value, or an upper and lower value including any of 400 nm, 600 nm, 800 nm, 1000 nm, 1200 nm, 1400 nm, 1600 nm, 1800 nm, 2000 nm, 2200 nm, 2400 nm, or any values therebetween”; Pars. [0055]-[0056]: optical energy with a wavelength of 570nm; Par. [0061]: wavelength can be between 500nm and 600nm), and wherein the laser pulse is synchronized with a rarefaction phase of the acoustic enemy burst at the target location (e.g. Abstract; Par. [0009]: providing acoustic and optical energy concurrently to cause cavitation, “providing an optical energy to the target location concurrently with the acoustic energy… The combination of the pressure of the acoustic energy and the fluence of the optical energy causes cavitation in blood.”; Par. [0045]: laser pulse is delivers at the beginning of each ultrasound burst to overlay the rarefaction phase at the target location).
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 Unser to include inducing cavitation, wherein the laser pulses have a wavelength of no more than 800 nanometers, and wherein the laser pulse is synchronized with a rarefaction phase of the acoustic enemy burst at the target location as taught by Yang because doing so would allow the wavelength to be tuned to the peak optical absorption wavelength of the target material, such as hemoglobin (e.g. Yang, par. [0036]).
Regarding claim 19, Unser fails to disclose repeating the acoustic energy burst and laser pulse for a treatment time of less than 150 seconds to produce thrombolysis. Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses repeating the acoustic energy burst and laser pulse for a treatment time of less than 150 seconds (e.g. Par. [0049]: treatment time can be 1 minute, which is 60 seconds).
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 Unser in view of Yang to include repeating the acoustic energy burst and laser pulse for a treatment time of less than 150 seconds as taught by Yang because doing so would provide the necessary length of treatment to produce thrombolysis.
Claims 3 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Unser et al. (US Patent Application Publication 2014/0236118), hereinafter Unser, in view of Yang et al. (US Patent Application Publication 2017/0312552 – of record), hereinafter Yang, as applied to claims 1 and 17 above, and further in view of Nguyen et al. (US Patent Application Publication 2017/0143359 – of record), hereinafter Nguyen.
Regarding claim 3, Unser fails to disclose the system further comprising a particle filter circumferentially attached to the terminal end of the optical conduit. Nguyen, in a similar field of endeavor, is directed towards a thrombus capture system. Nguyen discloses the system comprising a filter circumferentially attached to the terminal end of the optical conduit to remove debris such as blood clots (e.g. Abstract; Par. [0108]: thrombus capture system 8; Fig. 1: thrombus catching system circumferentially attached to terminal end of the catheter).
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 Unser in view of Yang to include a filter as taught by Nguyen because doing so would capture and remove debris such as blood clots.
Regarding claim 20, Unser fails to disclose capturing debris from a blood clot at the target location with a filter positioned on the optical conduit. Nguyen, in a similar field of endeavor, is directed towards a thrombus capture system. Nguyen discloses capturing debris from a blood clot at the target location with a filter positioned on the optical conduit (e.g. Abstract; Par. [0108]: thrombus capture system 8; Fig. 1: thrombus catching system circumferentially attached to terminal end of the catheter).
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 Unser in view of Yang to include a filter as taught by Nguyen because doing so would allow capturing and removing debris such as blood clots.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Unser et al. (US Patent Application Publication 2014/0236118), hereinafter Unser, in view of Yang et al. (US Patent Application Publication 2017/0312552 – of record), hereinafter Yang, as applied to claim 1 above, and further in view of Neuberger (US Patent Application Publication 2010/0179525 – of record).
Regarding claim 4, Unser fails to disclose wherein the terminal end of the optical conduit includes an optical diffuser tip for expanding an illumination area of the optical energy emitted from the optical conduit. Neuberger, in a similar field of endeavor, is directed towards treating veins. Neuberger discloses wherein the terminal end of the optical conduit includes an optical diffuser tip for expanding an illumination area of the optical energy emitted from the optical conduit (e.g. Par. [0097]: the diffuser tip leads to efficient 360 degree radial emission).
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 Unser in view of Yang to include the diffuser tip as taught by Neuberger because doing so would expand the illumination area.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Unser et al. (US Patent Application Publication 2014/0236118), hereinafter Unser, in view of Yang et al. (US Patent Application Publication 2017/0312552 – of record), hereinafter Yang, as applied to claim 1 above, and further in view of Hennings et al. (US Patent Application Publication 2013/0218146 – of record), hereinafter Hennings.
Regarding claim 5, Unser fails to disclose wherein the optical conduit has a diameter less than 750 microns. Hennings, in a similar field of endeavor, is directed towards inducing thrombolysis. Hennings discloses wherein the optical conduit has a diameter less than 750 microns (e.g. Par. [0037]: optical fiber with diameter of 100-550 microns). 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 Unser in view of Yang to include the diameter of the optical conduit as taught by Hennings because doing so would allow the optical fiber to easily be inserted into the vessel.
Regarding claim 7, Unser further discloses transmitting an acoustic signal, providing the sequence of laser pulses, and emitting the sequence of laser pulses (e.g. Par. [0061]: ultrasound and light can be combined to identify blood clots invasively or noninvasively; Par. [0082]: ultrasonic energy can be used to ablate the thrombus; Par. [0102]). However, Unser fails to specifically disclose emitting the energy without damaging the tissue space or the blood vessel. Hennings, in a similar field of endeavor, is directed towards inducing thrombolysis. Hennings discloses emitting the energy without damaging the tissue space or the blood vessel (e.g. Par. [0033]; Par. [0114]: “the laser energy delivered…will do little or no damage to the tissue surrounding the vein, including very little heating of the tissue that would otherwise cause pain, swelling or purpura in the dermis”).
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 Unser in view of Yang to include emitting the energy without damaging the tissue space or the blood vessel as taught by Hennings because doing so would allow effective treatment without damaging any surrounding tissue.
Claims 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Unser et al. (US Patent Application Publication 2014/0236118), hereinafter Unser, in view of Yang et al. (US Patent Application Publication 2017/0312552 – of record), hereinafter Yang, as applied to claim 6 above, and further in view of Janis et al. (Abram D. Janis, Lisa A. Buckley, Kenton W. Gregory M.D., "Laser thrombolysis in an in-vitro model," Proc. SPIE 3907, Lasers in Surgery: Advanced Characterization, Therapeutics, and Systems X, (17 May 2000); https://doi.org/10.1117/12.386303 – of record), hereinafter Janis.
Regarding claim 10, Unser fails to specifically disclose wherein the optical power of the laser pulses is about 50mW or less. Janis is directed towards laser thrombolysis. Janis discloses wherein an optical power of the laser pulses is between about 1 and 200 mW (e.g. Abstract: average power used was about 100 mW).
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 Unser in view of Yang to include the optical power being between 1 and 200 mW as taught by Janis because doing so would allow efficient blood clot removal.
Unser in view of Yang and Janis discloses the claimed invention except for the optical power being 50 mW or less. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the invention as taught by Unser in view of Yang and Janis with the optical power being 50 mW or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art [In re Aller, 105 USPQ 233].
Regarding claim 12, Unser fails to disclose wherein a laser power of the laser pulses is less than 100 mW and an ultrasound pressure of the acoustic energy burst is less than 5 MPa. Yang, in a similar field of endeavor, is directed towards a method and apparatus for removing microvessels using acoustic and optical energy. Yang discloses an ultrasound pressure of the acoustic energy burst is less than 5 MPa (e.g. Par. [0046]).
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 Unser in view of Yang to include the acoustic energy burst having a pressure of 1MPa or less as taught by Yang because doing so would allow precise targeting of the target location to provide treatment.
However, Unser in view of Yang fails to disclose wherein a laser power of the laser pulses is less than 100 mW. Janis is directed towards laser thrombolysis. Janis discloses wherein an optical power of the laser pulses is between about 1 and 200 mW (e.g. Abstract: average power used was about 100 mW).
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 Unser in view of Yang to include the optical power being between 1 and 200 mW as taught by Janis because doing so would allow efficient blood clot removal.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Unser et al. (US Patent Application Publication 2014/0236118), hereinafter Unser, in view of Yang et al. (US Patent Application Publication 2017/0312552 – of record), hereinafter Yang, as applied to claim 17 above, and further in view of Gertner et al. (US Patent Application Publication 2011/0257561 – of record), hereinafter Gertner.
Regarding claim 18, Unser further discloses aiming the terminal end of the optical conduit (e.g. Par. [0102]). However, Unser fails to disclose aiming the terminal end of the optical conduit with a guidewire positioned inside the optical conduit. Gertner, in a similar field of endeavor, is directed towards the treatment of a nervous system of a patient using ultrasound energy. Gertner discloses positioning the catheter with a guidewire positioned inside (e.g. Par. [0254]: a guidewire is used determine treatment areas).
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 Unser in view of Yang to include positioning the catheter with a guidewire positioned inside as taught by Gertner because doing so would provide improved detection of treatment areas.
Conclusion
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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