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 Objections
Claim 6 is objected to because of the following informalities:
In Claim 6, lines 1 and 2, "first laser diodes" should read "first kind of laser diodes".
In Claim 6, line 2, "second laser diode" should read "second kind of laser diodes".
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 6 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 is indefinite because it is unclear what, if any, structural limitation is imposed by this language. All claims are directed to an apparatus; however, claim 4 appears to define a spatial relationship relative to a patient (i.e. the user chooses to place the irradiated area at least 5 cm away) rather than a structural feature of the device.
Claim 6 recites the limitation "irradiated surface" in line 4. There is insufficient antecedent basis for this limitation in the claim and it is unclear whether this is referring to “an affected area” of claim 1, or some other area.
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 1-3, 5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Belkowski et al. (US 20230012300A1), hereinafter Belkowski, in view of Loupis et al. (US 20160016001A1), hereinafter Loupis, and in further view of Walker et al. (US 11229804B1), hereinafter Walker.
Regarding claim 1, Belkowski teaches a laser illumination device (Fig. 1A, para. 0006 (light integrated device)) for treating a peripheral artery occlusive disease (para. 0027, (inflammatory conditions, tissue level, “increase circulation”)), which comprises:
a fixing frame (Fig. 1 para. 0026, (light panel), Fig. 3A, element 302A (clasp), combination of the panel and the clasp)), which includes a fixing member (Fig. 3A) and a bracket (Fig. 3A, element 302A (clasp)), the fixing member being disposed on a top of the bracket (Fig. 3A), wherein an area of an inner side of the fixing member is greater than 25 cm2 (para. 0029 (height of 11.8 inches is 29.97 centimeters and width of 11 inches is 27.94 centimeters)) and the inner side of the fixing member is disposed with a plurality of a first kind of diodes which are used to emit light with a wavelength between 620 and 700 nm (para. 0026 (LEDs, 600-750 nm, 630 nm)), and a wavelength between 900 and 1100 nm (para. 0025 (LEDs, 750-1000 nm, 850 nm));
a power source (para. 0052 (power source)), which is disposed on the fixing frame and is used to supply power to the plurality of the first kind and the second kind of diodes (para. 0052 (power source connected to LEDs), 0006 (processor causes LEDs to operate), 0092 (processor within the machine learning outputs light)); and
the plurality of the first kind of diodes and the plurality of the second kind of diodes are used to emit laser light of different wavelengths (para. 0026 (plurality of LEDs, red light, near infrared light)) to irradiate an affected area of a patient (para. 0047 (tissue area)) suffering from the peripheral arterial occlusive disease ((para. 0027, (inflammatory conditions, tissue level, “increase circulation”)).
Belkowski does not teach a plurality of a first kind of diodes are laser diodes, a plurality of a second kind of diodes are laser diodes, and a tripod, which is disposed at a bottom of the bracket to support the fixing frame.
However, Loupis teaches a laser illumination device (Fig. 1, element 100 (device for emitting light)) for treating a peripheral arterial occlusive disease (para. 0219 (ulcers), which comprises:
a fixing frame (Fig. 1, element 108, para. 0144 (body)) which includes a fixing member and a bracket (Fig. 1, element 106, para. 0144 (head)), the fixing member being disposed on a top of the bracket (Fig. 1), and the inner side of the fixing member is disposed with a plurality of a first kind of laser diodes (para. 0115 (diode lasers)) which are used to emit laser light with a wavelength between 620 and 700 nm (para. 0049 (635-750 nm)), and a plurality of a second kind of laser diodes which are used to emit laser light with a wavelength between 900 and 1100 nm (para. 0153 (third set of LEDs, 800-1000 nm);
the plurality of the first kind of laser diodes and the plurality of the second kind of laser diodes (para. 0115 (diode lasers)) are used to emit laser light of different wavelengths (para. 0053 (emit light from a plurality of light sources), to irradiate an affected area of a patient suffering from the peripheral arterial occlusive disease (para. 0095 (treatment area irradiated)).
Loupis does not teach a tripod which is disposed at a bottom of the bracket to support the fixing frame.
However, Walker teaches a tripod (Fig. 4A, col. 8, lines 59-61 (tripod supports the light sources), which is disposed at a bottom of the bracket to support the fixing frame (Fig. 4A, element 44 (mount)).
Belkowski, Loupis, and Walker are considered to be analogous to the claimed invention because they are in the same field of light integrated devices for phototherapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Belkowski to incorporate the teachings of Loupis and provide a plurality of laser diodes emitting different wavelengths. Loupis discloses light sources capable of emitting light with characteristics corresponding to both light emitting diodes and diode lasers, thereby suggesting the interchangeability or supplementation of such light sources in Belkowski’s device.
Additionally, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Belkowski to incorporate the teachings of Walker and provide a tripod for the laser illumination device. Belkowski teaches a base (Fig. 3A), while Walker teaches a tripod, it is well known in the art to use a tripod for a base.
Regarding Claim 2, Belkowski (in view of Loupis and in further view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski further discloses a heat dissipation member disposed outside the fixing member (para. 0044 (heat dissipation module in light panel, manages temperature of LEDs)) to dissipate heat generated by the plurality of laser diodes.
Regarding Claim 3, Belkowski (in view of Loupis and in further view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski further discloses wherein the number of each of the plurality of the first kind of laser diodes and the plurality of the second kind of laser diodes is at least 8 (para. 0006 (one or more LEDs), para 0038 (8 LEDs on each row)).
Regarding Claim 5, Belkowski (in view of Loupis and in further view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski further discloses wherein the inner side of the fixing member is in a planar or curved shape (para. 0028 (curved light panel)).
Regarding Claim 7, Belkowski (in view of Loupis and in further view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski further discloses wherein the power source is further connected to a timing device so that the power source automatically turns off at a set time (para. 0033 (light panel includes a timer configured to automatically shut-off light panel)).
Claims 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Belkowski, in view of Walker, and in further view of Loupis.
Regarding Claim 4, Belkowski (in view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski (in view of Walker) does not teach wherein a distance between the plurality of the first kind and/or the second kind of laser diodes on the inner side of the fixing member and the affected area of the patient is greater than 5 cm.
Loupis teaches a laser illumination device (Fig. 1, element 100 (device for emitting light)), wherein a distance between the plurality of the first kind and/or the second kind of laser diodes on the inner side of the fixing member and the affected area of the patient is greater than 5 cm (para. 0013 (treatment distance 5-10 cm)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Belkowski to incorporate the teachings of Loupis and provide a distance range from the plurality of laser diodes to the affected area of a patient. Doing so would allow for efficient irradiation of the treatment area to ensure a therapeutic effect, and improving patient safety.
Regarding Claim 8, Belkowski (in view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski further discloses a programmable digital controller (para. 0077 (processor located at the device)) for controlling the power source (para. 0052 (power source connected to LEDs), 0006 (processor causes LEDs to operate), 0092 (processor within the machine learning outputs light)), ensuring that a light power density of the laser light emitted by the plurality of the first kind and the second kind of laser diodes (para. 0039 (irradiance of light)) on the patient's affected area (para. 0027 (emit light towards a subject)).
Belkowski (in view of Walker) does not teach a light power density range from 8 to 200 mW/cm².
Loupis teaches a laser illumination device (Fig. 1, element 100 (device for emitting light)), which further comprises a programmable digital controller (Fig. 1, element 114)) for controlling the power source (para. 0146 (powers on/off LEDs)), ensuring that a light power density of the laser light emitted by the plurality of the first kind and the second kind of laser diodes (para. 0105 (modulates the power density of the light)) on the patient's affected area ranges from 8 to 200 mW/cm² (para. 0013 (power density of the light, about 15 to 75 mW/cm²)).
It would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Belkowski to incorporate the teachings of Loupis and provide a light power density range for the plurality of laser diodes to the affected area of a patient. Doing so would ensure that the light power density is in the range to provide therapeutic effects, as well as prevents the patient from having tissue damage or discomfort due to possible overheating.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Belkowski, in view of Loupis, and in further view of Walker and Liu et al. (US 20130190845A1), hereinafter Liu.
Regarding Claim 6, Belkowski (in view of Loupis and in further view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski further discloses wherein the plurality of the first laser diodes and the plurality of the second laser diodes are respectively installed on the inner side of the fixing member in an interleaved manner (Fig. 1A, para. 0038 (arranged in a random pattern)). Belkowski (in view of Loupis and in further view of Walker) does not teach a maximum and a minimum light intensities on an irradiated surface are within ±30% of an average light intensity.
Liu teaches a laser illumination device (abstract), wherein the plurality of the first laser diodes (para. 0006 (one or more first LEDs that emit light primarily at a first wavelength)) and the plurality of the second laser diodes (para. 0006 (one or more second LEDs that emit light primarily at a second wavelength)) are respectively installed on the inner side of the fixing member (para. 006 (positioned along a panel edge)) in an interleaved manner (para. 0083 (non-uniform spaced LEDs)), ensuring that a maximum and a minimum light intensities on an irradiated surface are within ±30% of an average light intensity (para. 0012 (uniformity of light projection of +/- 30% over the area of the panel front surface), 0078 (light emitted from the LEDs enters into panel through edge)).
Belkowski and Liu are both considered to be analogous to the claimed invention because they are in the same field of light integrated devices for phototherapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Belkowski to incorporate the teachings of Liu and provide an irradiated surface within ±30% of an average light intensity. Doing so would promote the consistent therapeutic effectiveness and reduces overexposure or underexposure to the irradiated surface.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Belkowski, in view of Loupis, and in further view of Walker and Cassano et al. (US 20220323784A1), hereinafter Cassano.
Regarding Claim 9, Belkowski (in view of Loupis and in further view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above.
Belkowski further discloses wherein the power source provides the power in an alternating manner (para. 0052 (power source connected to LEDs), 0006 (processor causes LEDs to operate), 0092 (processor within the machine learning outputs light)). Belkowski (in view of Loupis and in further view of Walker) does not teach a frequency range of 40 to 1000 Hz.
Cassano teaches a laser illumination device (para. 0002 (device for photo biomodulation therapy)) wherein the power source (Fig. 1, element 200 (controller), para. 0065 (controller supplies power to light sources)), provides the power in an alternating manner (para. 0104 (controller controls power level and pulsed/continuous operation of light sources)) with an alternating frequency of 40 to 1000 Hz (para. 0047 (emit light in a frequency range, about 40 Hz), 0048 (about 1000 Hz), para. 0104 (an individual light source can be actuated in a pulsed or continuous mode independent of other light sources)).
Belkowski and Cassano are both considered to be analogous to the claimed invention because they are in the same field of light integrated devices for phototherapy. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Belkowski to incorporate the teachings of Cassano and provide a power supply having an alternating frequency of 40 to 1000 Hz. Doing so would provide adjustment of the light sources to achieve a desired therapeutic effect. Similarly, selecting a frequency range optimized treatment efficiency and irradiation time.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Belkowski, in view of Loupis, and in further view of view of Walker and Herzog et al. (US 20230404667A1), hereinafter Herzog.
Regarding Claim 10, Belkowski (in view of Loupis and in further view of Walker) teaches a laser illumination device comprising the features of claim 1 as discussed above. Belkowski further discloses temperature sensor (para. 0081 (temperature sensor)) installed on the fixing member for sensing a skin temperature of the patient (para. 0081 (body part temperature)). Belkowski (in view of Loupis and in further view of Walker) does not explicitly disclose that the temperature sensor is infrared.
Herzog teaches a teaches an infrared temperature sensor (para. 0042 (infrared sensor)) installed on the fixing member for sensing a skin temperature of the patient (para. 0042 (measuring the temperature of the patient’s skin)).
Belkowski and Herzog are both considered to be analogous to the claimed invention because they are in the same field of laser skin treatment. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Belkowski to incorporate the teachings of Herzog and provide an infrared temperature sensor. Doing so would allow the sensor to reach the infrared ranges of the wavelengths, thereby providing patient safety to prevent overheating.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EILEEN ROBLES whose telephone number is (571)429-9383. The examiner can normally be reached Monday-Friday: 7:30 - 5:00 PM.
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/EILEEN ROBLES/Examiner, Art Unit 3792
/MICHAEL W KAHELIN/Primary Examiner, Art Unit 3792