DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first
inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections
set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 5, 8-9, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over
Tedford et al. US Pub.: US 20160067086 A1, hereinafter Tedford in view of Opperman et al. US Pub.: US 10786693 B1, hereinafter Opperman.
Regarding claim 1, Tedford teaches a surgical system for treating ischemic tissue comprising: an
oxygenation sensor (754)operable to detect an oxygenation status of a tissue (fig. 7; paragraph 97); An oxygenation sensor is used for blood gas (O2) measurement.
a laser source (756) operable to emit treatment laser light (fig. 4 and 7; paragraph 66 and 96); Light sources may include laser diodes and lasers.
and a processor (750) in communication with the oxygenation sensor (754) and the laser source (756), wherein the processor (750) is operable to generate a feedback signal related to utilization of the laser source (756) in relation to the tissue based on the oxygenation status (fig. 4 and 7; paragraph 97); An oxygenation sensor is used for blood gas (O2) measurement, which can provide real-time feedback information to the logic circuit 750. The logic circuit can thus provide automatic real-time closed-loop monitoring and adjustment of various parameters of the applied light to enhance or optimize the phototherapy.
However, Tedford does not explicitly teach wherein the oxygenation sensor operable to detect an oxygenation status of a tissue based on illumination light reflected from the tissue.
Opperman, teaches a biometric monitoring system and further teaches an oxygenation sensor operable to detect an oxygenation status of a tissue based on illumination light reflected from the tissue (col. 22, lines 10-62). Back scatter sensors operate by generating a source of light at a known frequency and wavelength, and then measuring the amount of light that bounces or reflects back to the measurement sensor which is on the same side as the light generator. More specifically, with regard to the preferred sensor, the pulse oximeter can measure the oxygenation of the subject's blood by producing a source of light originating from the oximeter at two wavelengths (650 nm and 805 nm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor from Tedford to add the oxygenation sensor from Opperman for the benefit of measuring the oxygenation of the subject's blood and respiration of the subject (col. 22, lines 10-62).
Regarding claims 5 and 13, Tedford in view of Opperman teaches the claimed invention and
Tedford further teaches wherein the processor (750) is further operable to: receive an operator command to transmit the treatment laser light responsive to the signaling; and cause the laser source (756) to transmit the treatment laser light to the tissue responsive to the operator command (fig. 4 and 7; paragraph 97-98); The logic circuit can thus provide manual closed-loop monitoring and adjustment of various parameters of the applied light to enhance or optimize the phototherapy. For example, the user/operator manually adjusts the device output such that the desired dosage is delivered to the target areas.
Regarding claims 8 and 15, Tedford in view of Opperman teaches the claimed invention and
Tedford further teaches wherein the tissue comprises ocular tissue on a retinal surface of an eye (paragraph 32). The multi-wavelength device is used in combination with other pharmaceuticals or devices to enhance or personalize phototherapy treatment to ocular tissues.
Regarding claim 9 Tedford teaches a computer implemented method of treating ischemic tissue,
the method comprising: detecting, at an oxygenation sensor, an oxygenation status of a tissue (fig. 7; paragraph 97); An oxygenation sensor is used for blood gas (O2) measurement.
and generating, at a processor (750), a feedback signal related to utilization of a laser source (756) in relation to the tissue based on the oxygenation status (fig. 4 and 7; paragraph 66 and 96); Light sources may include laser diodes and lasers. (fig. 4 and 7; paragraph 97). An oxygenation sensor is used for blood gas (O2) measurement, which can provide real-time feedback information to the logic circuit 750. The logic circuit can thus provide automatic real-time closed-loop monitoring and adjustment of various parameters of the applied light to enhance or optimize the phototherapy.
However, Tedford does not explicitly teach wherein the oxygenation sensor operable to detect an oxygenation status of a tissue based on illumination light reflected from the tissue.
Opperman, teaches a biometric monitoring system and further teaches an oxygenation sensor operable to detect an oxygenation status of a tissue based on illumination light reflected from the tissue (col. 22, lines 10-62). Back scatter sensors operate by generating a source of light at a known frequency and wavelength, and then measuring the amount of light that bounces or reflects back to the measurement sensor which is on the same side as the light generator. More specifically, with regard to the preferred sensor, the pulse oximeter can measure the oxygenation of the subject's blood by producing a source of light originating from the oximeter at two wavelengths (650 nm and 805 nm).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensor from Tedford to add the oxygenation sensor from Opperman for the benefit of measuring the oxygenation of the subject's blood and respiration of the subject (col. 22, lines 10-62).
Claims 2-3 and 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et
al. US Pub.: US 20160067086 A1, hereinafter Tedford in view of Opperman et al. US Pub.: US 10786693 B1, hereinafter Opperman in view of Samec et al. US Pub.: US 20160287153 A1, hereinafter Samec.
Regarding claims 2 and 10, Tedford in view of Opperman teaches the claimed invention and
Tedford further teaches wherein the generation of the feedback signal comprises: determining, based on the oxygenation status; and responsive to the determining, automatically causing the laser source (756) to transmit the treatment laser light to the tissue, the feedback signal comprising an instruction to the laser source (fig. 4 and 7; paragraph 97); An oxygenation sensor is used for blood gas (O2) measurement, which can provide real-time feedback information to the logic circuit 750. The logic circuit can thus provide automatic real-time closed-loop monitoring and adjustment of various parameters of the applied light to enhance or optimize the phototherapy.
However, Tedford in view of Opperman does not explicitly teach that the feedback signal may comprise a determination that the tissue is deoxygenated.
Samec teaches an augmented reality pulse oximetry system and further teaches a determination that the tissue is deoxygenated (fig. 5; paragraph 23). The one of more detectors (828, 830) may comprise photodiodes, photodetectors, or digital camera sensors, and preferably are positioned and oriented to receive radiation that has encountered the targeted tissue comprising oxygenated and deoxygenated hemoglobin.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the detection system of Tedford in view of Opperman to add the detection system from Samec for the benefit of providing the utility so that absorption may be detected and oxygen saturation calculated/estimated (paragraph 23).
Regarding claims 3 and 11, Tedford in view of Opperman teaches the claimed invention and
Tedford further teaches wherein the generation of the feedback signal comprises: determining, based on the oxygenation status; and signaling an operator to manually transmit the treatment laser light to the tissue (fig. 4 and 7; paragraph 97-98); An oxygenation sensor is used for blood gas (O2) measurement, which can provide real-time feedback information to the logic circuit 750. The logic circuit can thus provide manual closed-loop monitoring and adjustment of various parameters of the applied light to enhance or optimize the phototherapy. For example, the user manually adjusts the device output such that the desired dosage is delivered to the target areas.
However, Tedford in view of Opperman does not explicitly teach that the feedback signal may comprise a determination that the tissue is deoxygenated.
Samec teaches an augmented reality pulse oximetry system and further teaches a determination that the tissue is deoxygenated (fig. 5; paragraph 23). The one of more detectors (828, 830) may comprise photodiodes, photodetectors, or digital camera sensors, and preferably are positioned and oriented to receive radiation that has encountered the targeted tissue comprising oxygenated and deoxygenated hemoglobin.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the detection system of Tedford in view of Opperman to add the detection system from Samec for the benefit of providing the utility so that absorption may be detected and oxygen saturation calculated/estimated (paragraph 23).
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. US
Pub.: US 20160067086 A1, hereinafter Tedford in view of Opperman et al. US Pub.: US 10786693 B1, hereinafter Opperman in view of Gamelin et al. US Pub.: US 20110237910 A1, hereinafter Gamelin.
Regarding claims 4 and 12, Tedford in view of Opperman teaches the claimed invention, but
does not teach wherein the signaling comprises initiating at least one of visual, auditory, or haptic feedback to the operator.
Gamelin teaches spectrophotometric monitoring and further teaches wherein the signaling comprises initiating at least one of visual, auditory, or haptic feedback to the operator (paragraph 26, 29, and 36). The resultant physiological parameters (e.g., tissue oxygenation concentration or saturation levels) may be visually displayed on the user display 32.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tedford in view of Opperman to add a user display from Gamelin for the benefit of providing feedback of the patient’s physiological parameters (e.g., tissue oxygenation concentration or saturation levels) (paragraph 26, 29, 36).
Claims 6 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. US
Pub.: US 20160067086 A1, hereinafter Tedford in view of Opperman et al. US Pub.: US 10786693 B1, hereinafter Opperman in view of Samec et al. US Pub.: US 20160287153 A1, hereinafter Samec in view of MALCHANO et al. US Pub.: US 20230166072 A1, hereinafter Malchano.
Regarding claims 6 and 14, Tedford in view of Opperman in view of Samec teaches the claimed
invention and Samec further teaches wherein the generation of the feedback signal comprises: determining, based on the oxygenation status, that the tissue is oxygenated (fig. 5; paragraph 23). The one of more detectors (828, 830) may comprise photodiodes, photodetectors, or digital camera sensors, and preferably are positioned and oriented to receive radiation that has encountered the targeted tissue comprising oxygenated and deoxygenated hemoglobin.
Malchano teaches stimulation therapy and further teaches blocking utilization of the laser
source responsive to the determining (paragraph 150). The light generation module 110 can interface, control, or otherwise manage various types of visual signaling components 150 in order to cause the visual signaling component 150 to generate, block, control, or otherwise provide the visual signal having one or more predetermined parameters.
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the control system from Tedford in view of Opperman in view of Samec to add the blocking control step from Malchano for the benefit of reducing the effect of the unwanted frequency on the neural oscillations (paragraph 189).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Tedford et al. US Pub.: US
20160067086 A1, hereinafter Tedford in view of Opperman et al. US Pub.: US 10786693 B1, hereinafter Opperman in view of Peyman US Pub.: US 20190030190 A1.
Regarding claim 7, Tedford in view of Opperman teaches the claimed invention and Tedford
further teaches further comprising: an illumination source (756) in communication with the processor (750) and operable to emit the illumination light to the tissue.
However, Tedford in view of Opperman does not teach a surgical probe, the surgical probe including an optical fiber operatively coupled to the laser source and the illumination source, wherein the optical fiber is operable to transmit both the treatment laser light from the laser source and the illumination light from the illumination source.
Peyman teaches methods to regulate polarization and further teaches a surgical probe, the surgical probe including an optical fiber operatively coupled to the laser source and the illumination source, wherein the optical fiber is operable to transmit both the treatment laser light from the laser source and the illumination light from the illumination source (paragraph 145-147, 215 and 242). Fiber optic probes are operatively coupled to a light source. The light source may alternately be single or multiple wavelengths scanned-beam system, using one or more discrete light sources, e.g., LEDs or low power lasers.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Tedford in view of Opperman to add the probe from Peyman for the benefit of providing accurate delivery of treatment towards the patient’s eye (paragraph 242).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THIEN J TRAN whose telephone number is (571)272-0486. The examiner can normally be reached M-F. 8:30 am - 5:30 pm.
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/T.J.T./Examiner, Art Unit 3792
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796
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