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
Claims 12 and 14-15 are objected to because of the following informalities:
Claim 12 should be amended to recite “…which is easier to irradiate and forms a functional connection with the node located deeply inside the brain.” This amendment will help remain consistent with claim language and increase clarity.
Claim 14 recites “other psychological disorder of the patient” which should be amended to recite “other psychological disorders of the patient”.
Claim 14, line 4 should be amended to recite “…brain network nodes relation to [[an other]] another psychological disorders…”
Claim 15, lines 4-5 should be amended to recite “…at least one of a medial prefrontal cortex, a medial temporal lobe, a cingulate cortex, a precuneus, and an inferior parietal lobe.”
Appropriate correction is respectfully requested.
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 1-3, 5, 7-8, 10-20, 22-23, and 25 are 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.
Regarding claim 1, the limitation “a hood body that loosely accommodates, rather than adapts to, a patient's head” renders the claim unclear. Specifically, it is unclear as to what “loosely accommodates” requires. Further, any hood, cap, helmet, hat, etc. shaped to accommodate a patient’s head would necessarily adapt to a patient’s head. In order to further advance prosecution Examiner is interpreting “a hood body that loosely accommodates” as any rigid element shaped to receive a user’s head. Examiner suggests amending the claim to remove the above limitation or further explain what is required by “loosely accommodates”. Dependent claims inherit the same deficiencies.
Regarding claim 1, the limitation “an array of near-infrared irradiation units…a light transmittable portion…which is constructed to emit via the light transmittable portion near-infrared light…” renders the claim unclear. As the claim is currently written, it is unclear if the array of near-infrared irradiation units or the transmittable portion is constructed to emit light via the light transmittable portion. Dependent claims inherit the same deficiencies.
In order to further advance prosecution, Examiner is interpreting the array of near-infrared irradiation units as being constructed to emit light via the light transmittable portion. Examiner suggests amending claim 1 to recite:
“an array of near-infrared irradiation units arranged in the hood body;
a light transmittable portion [[is]] provided at the inner side of the array of near-infrared irradiation units, wherein the array of near-infrared irradiation units are [[which is]] constructed to emit, via the light transmittable portion, near-infrared light with an emergent…”.
Claim 12 recites the limitation "the condition" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the condition" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the condition" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the functional connection strength" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 14, the limitation “based on other psychological disorder of the patient…” renders the claim unclear. Specifically, it is unclear if the claim requires the patient to have a first psychological disorder since Alzheimer’s Disease is a neurogenerative disorder and not a psychological disorder. For examination purposes, Examiner is interpreting the claim as requiring one psychological disorder in addition to Alzheimer’s Disease. Examiner suggests amending the claim to recite “a psychological disorder” in place of “other psychological disorder”.
Claim 16 recites the limitation "the patient’s brain network nodes" in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the functional strength" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 16, the limitation “the functional connection strength of which with a hippocampus is weaker than a predetermined level” renders the claim unclear. It is unclear if the phototherapy apparatus is configured to conditionally deliver phototherapy based on a functional connection strength or if the phototherapy apparatus is intended to be used when a functional connection strength is weaker than a predetermined level. In order to further advance prosecution, Examiner is interpreting the functional connection strength being weaker than a predetermined level as an intended use for the phototherapy apparatus. Further, the additional limitation of “a functional connection strength of each node with the hippocampus is determined by cerebral functional imaging of the patient” renders the claim unclear. Specifically, it is unclear if the claim requires cerebral functional imaging or not since there is no structure recited in the claim that is capable of performing the imaging. For examination purposes, Examiner is interpreting the claim as not requiring the cerebral functional imaging.
Claim 22 recites the limitation "the top portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 recites the limitation "the condition" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 3, 11 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by De Taboada et al (US 2007/0179571) hereinafter Taboada.
Regarding claim 1, Taboada discloses a phototherapy apparatus for treating Alzheimer's disease (Fig. 1), comprising:
a hood body (cap 60) that loosely accommodates, rather than adapts to, a patient's head [0073], so as to enable the head to rotate within a predetermined angle range and move in an up-down direction within a predetermined distance range during treatment (Examiner notes the patient would be able to rotate their head as well as move their head in an up-down direction while wearing the cap 60 as shown in Fig. 1);
an array of near-infrared irradiation units arranged in the hood body ([0073] cap 60 hold light source 40; [0086] light source 40 comprises a plurality of light sources 40a, 40b, 40c; [0098] light source 40 preferably generates light in the visible to near-infrared wavelength range),
a light transmittable portion (element 50) is provided at the inner side of the array of near-infrared irradiation units ([0079] element 50 is within an optical path of the light from the light source 40 to the scalp 30), which is constructed to emit via the light transmittable portion near-infrared light with an emergent average irradiance greater than 40mW/cm2 towards the patient's head ([0105] surface power densities between about 100 mW/cm2 to about 500 mW/cm2), and a total power of which is 10W or more ([0105] To achieve such surface power densities, the light source 40 is preferably capable of emitting light energy having a total power output of at least about 25 mW to about 100 W); and
a cooling mechanism (Fig. 3: inlet conduit 52) configured to introduce cooled gas and send it into an accommodation cavity of the hood body (inside of cap 60) for accommodating the patient's head ([0083] air can flow in from inlet 52 into container 51; Fig. 3 shows the container 51 being between the inner wall of the cap and the scalp; Examiner notes the inside of the cap creates an accommodation cavity and the inlet 52 allows air to flow into the inside of the cap),
blowing it towards the patient's head through a cooled gas delivering pathway between the hood body and the patient's head to dissipate heat from the patient's head ([0083] air can flow from the inlet conduit 52, absorb heat from the scalp 30, and flow out of the container 51 through the outlet conduit 53; Examiner notes this would require blowing the air from the inlet 52 towards the patient’s head in order for the air to reach the container 51 as shown in Fig. 3).
Regarding claim 3, Taboada discloses wherein the array of near-infrared irradiation units is constructed to emit near-infrared light with a central wavelength of 800-820nm towards the patient's head; and/or the array of near-infrared irradiation units is constructed to emit single wavelength near-infrared light with a central wavelength of 810nm towards the patient's head ([0100] includes wavelengths of about 800, 805, 810, 815, 820, 825, or 830 nanometers).
Regarding claim 11, Taboada discloses wherein the hood body is constructed to cover at least a whole brain of the patient ([0073] cap 60 which fits securely over the patient's head), without covering eyes of the patient (Fig. 1).
Regarding claim 23, Taboada discloses wherein there is a first predetermined distance between adjacent near-infrared irradiation units in the array of near-infrared irradiation units ([0088] light sources 40 are preferably spaced sufficiently far apart from one another; Fig. 6A shows light sources 40 being spaced apart from each other),
there is a second predetermined distance between the array of near-infrared irradiation units and the head (Fig. 6A shows a distance between the light sources 40 and the scalp 30), and
the adjacent near-infrared irradiation units cooperatively emit near-infrared light to the patient's head at a predetermined divergence angle (Fig. 6A shows light sources 40 delivering light to the scalp 30 at a predetermined divergence angle), so that the emitted near-infrared light covers a target brain region under the condition that the patient's head remains stationary or moves within a movable gap within the hood body ([0088] the light emitted by the light sources 40 propagates from the light sources 40 through the scalp 30 to the brain 20 and disperses in a direction generally parallel to the scalp 30), and
the near-infrared light emitted by adjacent near- infrared irradiation units at a predetermined divergence angle overlaps at least partially in a projection area of the head ([0088] the light emitted from each light source 40 overlaps with the light emitted from the neighboring light sources 40 at the brain 20).
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.
Claim(s) 2, 19-20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada (US 2007/0179571) in view of Jo et al (US 2024/0245928) hereinafter Jo.
Regarding claim 2, Taboada discloses wherein the cooling mechanism comprises a refrigerator or is connectable to a refrigerator ([0083] A flowing material (e.g., water, air, or glycerol) can flow into the container 51 from the inlet conduit 52; Examiner notes the inlet conduit is connectable to a refrigerator). Taboada fails to disclose the hood body is provided with a cooled gas delivering inner cavity to receive cooled gas generated by the refrigerator, and the cooled gas delivering pathway is formed between the cooled gas delivering inner cavity and the patient's head.
However, Jo discloses a hood body ([0006] cap device) provided with a cooled gas delivering inner cavity to receive cooled gas generated by a refrigerator ([0006] The exterior cover is configured to define an air flow passage along an outer surface of the interior cover), and a cooled gas delivering pathway is formed between the cooled gas delivering inner cavity and the patient's head ([0006] blower is disposed in a position of an upper end of the interior cover to communicate with the air flow passage. The blower is configured to suck air through the vent hole and to emit the air to the scalp through the plurality of emitting holes via the air flow passage).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with a hood body being provided with a cooled gas delivering inner cavity to receive cooled gas generated by the refrigerator, and a cooled gas delivering pathway is formed between the cooled gas delivering inner cavity and the patient's head as taught by Jo. Such a modification would provide the predictable results of emitting air to the scalp to remove heat and lower the temperature of the scalp (Jo, [0038]).
Regarding claim 19, the modified Taboada discloses the system of claim 2 as discussed above, but fails to disclose wherein the hood body further includes a spacer, which is used to divide a chamber inside the hood body into a first chamber and a second chamber, wherein the first chamber is used to accommodate the array of near-infrared irradiation units, the second chamber is at least partially used as a cooled gas delivering inner cavity, and a wall of the second chamber on its side facing the patient's head has light transmittance.
However, Jo discloses wherein the hood body (cap device 10) further includes a spacer (substrate 300), which is used to divide a chamber inside the hood body into a first chamber (Fig. 3: air flow passage 240) and a second chamber ([0040] cap device 10 includes a substrate 300 disposed between the interior cover 100 and the exterior cover 200; Examiner notes the second chamber would be the inner space of interior cover 100 as shown in Fig. 3),
wherein the first chamber (Fig. 3: air flow passage 240) is used to accommodate the array of near-infrared irradiation units ([0054] diodes are mounted on the substrate 300 and are disposed in the air flow passage 240 between the interior cover 100 and the exterior cover 200),
the second chamber (Fig. 3: inner space of interior cover 100) is at least partially used as a cooled gas delivering inner cavity ([0044] interior cover 100 has a plurality of emitting holes 121 for emitting air to the scalp), and
a wall ([0043] inner surface 111) of the second chamber on its side facing the patient's head has light transmittance ([0042] A portion or the entirety of the interior cover 100 may be composed of a transparent material).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the hood body further including a spacer, which is used to divide a chamber inside the hood body into a first chamber and a second chamber, wherein the first chamber is used to accommodate the array of near-infrared irradiation units, the second chamber is at least partially used as a cooled gas delivering inner cavity, and a wall of the second chamber on its side facing the patient's head has light transmittance as taught by Jo. Such a modification would yield the predictable results of providing scalp care by irradiating laser light while lowering the temperature of the scalp (Jo, [0005]).
Regarding claim 20, Taboada discloses the system of claim 1 as discussed above, but fails to disclose wherein the hood body comprises an outer layer and an inner layer, the light transmittable portion serves as the inner layer and forms an integrated light transmittable cover, a cooled gas delivering inner cavity is formed between the outer layer and the light transmittable cover, the light transmittable cover is provided with a plurality of ventilation holes, so that each ventilation hole and a gap, at level of multiple centimeters, between the light transmittable cover and the patient's head form the cooled gas delivering pathway.
However, Jo discloses wherein a hood body (Fig. 3: cap device 10) comprises an outer layer ([0040] exterior cover 200) and an inner layer ([0040] interior cover 100),
the light transmittable portion serves as the inner layer and forms an integrated light transmittable cover ([0042] the interior cover 100 may be composed of a transparent material),
a cooled gas delivering inner cavity (air flow passage 240) is formed between the outer layer and the light transmittable cover ([0052] the exterior cover 200 coupled to the interior cover 100 is configured to define an air flow passage 240 along the outer surface 112 of the interior cover),
the light transmittable cover is provided with a plurality of ventilation holes (emitting holes 121), so that each ventilation hole and a gap between the light transmittable cover and the patient's head form the cooled gas delivering pathway ([0044] interior cover 100 has a plurality of emitting holes 121 for emitting air to the scalp; [0047] interior cover 100 may have a cushion member 150 which makes contact with a top portion of the scalp; Examiner notes this would create a gap between the interior cover 100 and the patients scalp; Figs. 2-3).
While Jo discloses a cushion member on the interior cover 100 which contacts the scalp [0047], Jo fails to explicitly teach that the cushion member causes a gap at a level of multiple centimeters between the light transmittable cover (interior cover 100) and the patient’s head.
However, Examiner submits that the claimed gap at a level of multiple centimeters is so close to the taught gap created by the cushion member 150 that a prima facia case of obviousness exists. One of ordinary skill in the art would expect a gap between a light transmittable cover and a scalp formed by a protruding cushion member 150 to have the same properties as a gap at a level of multiple centimeters between a light transmittable cover and a head (MPEP 2144.05(I): "Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America V. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of 'having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium' as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. 'The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.' See also Warner-Jenkinson Co., Inc. V. Hilton Davis Chemical Co., 520 U.S. 17, 41 USPQ2d 1865 (1997) (under the doctrine of equivalents, a purification process using a pH of 5.0 could infringe a patented purification process requiring a pH of 6.0-9.0); In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the hood body comprises an outer layer and an inner layer, the light transmittable portion serves as the inner layer and forms an integrated light transmittable cover, a cooled gas delivering inner cavity is formed between the outer layer and the light transmittable cover, the light transmittable cover is provided with a plurality of ventilation holes, so that each ventilation hole and a gap between the light transmittable cover and the patient's head form the cooled gas delivering pathway as taught by Jo. Such a modification would provide the predictable results of emitting air to the scalp to remove heat and lower the temperature of the scalp (Jo, [0038]).
Regarding claim 22, the modified Taboada discloses the system of claim 20 as discussed above, but fails to disclose wherein the top portion of the light transmittable cover is arch-shaped with a curvature less than a predetermined curvature, so that the introduced cooled gas diffuses gently to a periphery under a function of the arch-shaped top portion. However, Jo discloses wherein the top portion of the light transmittable cover is arch-shaped with a curvature less than a predetermined curvature ([0042] interior cover 100 may be formed by injection molding to have a substantially hemispherical shape), so that the introduced cooled gas diffuses gently to a periphery under a function of the arch-shaped top portion ([0053] air emitted from the blower 400 can flow through the air flow passage 240 while diffusing from the upper end of the interior cover 100 toward the lower end of the interior cover 100).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the top portion of the light transmittable cover is arch-shaped with a curvature less than a predetermined curvature, so that the introduced cooled gas diffuses gently to a periphery under a function of the arch-shaped top portion as taught by Jo. Such a modification would provide the predictable results of removing the heat applied to the scalp and cooling the scalp (Jo, [0064]).
Claim(s) 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada (US 2007/0179571) in view of Chen et al (US 2022/0362576) hereinafter Chen.
Regarding claim 5, Taboada discloses wherein the near-infrared light is a pulsed light ([0118] pulses of applied light), and irradiation parameters of a near-infrared irradiation unit of the array of near-infrared irradiation units further include a pulse frequency, the pulsed light includes a pulse wave component at a first pulse frequency and/or a pulse wave component at a second pulse frequency ([0118] pulse width times for pulses of applied light, and time intervals between pulses of applied light), but fails to disclose wherein the first pulse frequency is 7Hz-13Hz and the second pulse frequency is 30Hz-100Hz.
However, Chen discloses a pulse frequency being 1-100 Hz, preferably 8-50Hz [0019]. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with a first pulse frequency being 7Hz-13Hz and/or a second pulse frequency being 30Hz-100Hz as taught by Chen. Such a modification would provide the predictable results of delivering light therapy to treat Alzheimer's disease (Chen, Abstract).
Regarding claim 7, the modified Taboada discloses the system of claim 5 as discussed above, but fails to disclose wherein each near-infrared irradiation unit of the array of near-infrared irradiation units comprises a plurality of near-infrared light-emitting diodes, and
the pulsed light comprises pulse wave components with a wave frequency and y wave frequency as the first pulse frequency and the second pulse frequency, respectively, and is formed by any of the following manners:
a waveform of the pulsed light emitted by each near-infrared light-emitting diode is formed by synchronous aliasing of a wave and y wave;
the waveform of the pulsed light emitted by each near-infrared light-emitting diode is formed by time division combination of a wave and y wave;
each near-infrared light-emitting diode in a first group of the plurality of near-infrared light- emitting diodes emits pulsed light of a wave, each near-infrared light-emitting diode in a second group of the plurality of near-infrared light-emitting diodes emits pulsed light of y wave, and the first and second groups of near-infrared light-emitting diodes emit pulsed light synchronously.
However, Chen discloses wherein each near-infrared irradiation unit of the array of near-infrared irradiation units comprises a plurality of near-infrared light-emitting diodes ([0091] the near-infrared irradiation module 110 includes the first and the second light-emitting diode arrays), and
the pulsed light comprises pulse wave components with a wave frequency and y wave frequency as the first pulse frequency and the second pulse frequency, respectively ([0091] the first light-emitting diode array may adopt a pulse frequency of 1-100 Hz, preferably 8-50 Hz (preferably 10 Hz or 40 Hz), and the second light-emitting diode array may adopt a pulse frequency of 1-100 Hz, preferably 8-50 Hz (preferably 10 Hz or 40 Hz)), and is formed by any of the following manners:
the waveform of the pulsed light emitted by each near-infrared light-emitting diode is formed by time division combination of a wave and y wave ([0091] the first and second light-emitting diode arrays can emit light alternately within a certain period of time (for example, 6 minutes));
each near-infrared light-emitting diode in a first group of the plurality of near-infrared light- emitting diodes emits pulsed light of a wave, each near-infrared light-emitting diode in a second group of the plurality of near-infrared light-emitting diodes emits pulsed light of y wave, and the first and second groups of near-infrared light-emitting diodes emit pulsed light synchronously ([0091] the first and second light-emitting diode arrays can be turned on at the same time, and operate in a pulsed light irradiation mode within a certain period of time (for example, 6 minutes)).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with each near-infrared irradiation unit of the array of near-infrared irradiation units comprises a plurality of near-infrared light-emitting diodes, and the pulsed light comprises pulse wave components with a wave frequency and y wave frequency as the first pulse frequency and the second pulse frequency, respectively, and is formed by any of the following manners: the waveform of the pulsed light emitted by each near-infrared light-emitting diode is formed by time division combination of a wave and y wave; each near-infrared light-emitting diode in a first group of the plurality of near-infrared light- emitting diodes emits pulsed light of a wave, each near-infrared light-emitting diode in a second group of the plurality of near-infrared light-emitting diodes emits pulsed light of y wave, and the first and second groups of near-infrared light-emitting diodes emit pulsed light synchronously as taught by Chen. Such a modification would provide the predictable results of delivering light therapy to treat Alzheimer's disease (Chen, Abstract).
Examiner notes that the limitation of “a waveform of the pulsed light emitted by each near-infrared light-emitting diode is formed by synchronous aliasing of a wave and y wave” is claimed in the alternative and not positively recited. Therefore, the prior art discussed above satisfies the claim language as currently written.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada (US 2007/0179571) in view of Hamid (US 2017/0333730).
Regarding claim 8, Taboada discloses the system of claim 1 as discussed above, but fails to disclose wherein the cooling mechanism is further configured to blow the cooled gas towards the patient's head through the cooled gas delivering pathway with a wind speed of O.5m/s to 3.5m/s; and/or maintain a surface temperature of the light transmittable portion near a scalp of the patient not higher than 43°C under a condition that the phototherapy apparatus irradiates continuously for 30 minutes.
However, Hamid discloses wherein a cooling mechanism (vents) is further configured to maintain a surface temperature of the light transmittable portion near a scalp of the patient under a condition that the phototherapy apparatus irradiates continuously for 30 minutes (Claim 2: the vents are configured such that temperature rises inside the helmet during operation are limited to two degrees Fahrenheit over ambient outside). While Hamid does not expressly teach maintaining a surface temperature of the light transmittable portion near a scalp of the patient not higher than 43°C, Examiner notes that as long as the helmet is being operated in an area with an ambient temperature at or below approximately 107 degrees Fahrenheit, then the helmet would necessarily maintain a surface temperature of the light transmittable portion near a scalp of the patient not higher than 43°C.
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the cooling mechanism being further configured to maintain a surface temperature of the light transmittable portion near a scalp of the patient not higher than 43°C under a condition that the phototherapy apparatus irradiates continuously for 30 minutes as taught by Hamid. Such a modification would provide the predictable results of avoiding excessive heat buildup (Hamid, [0021]).
Examiner notes that the limitation “wherein the cooling mechanism is further configured to blow the cooled gas towards the patient's head through the cooled gas delivering pathway with a wind speed of O.5m/s to 3.5m/s” is claimed in the alternative and not positively recited. Therefore, the prior are discussed above satisfies the claim language as currently written.
Claim(s) 10, 12-13, 15, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada (US 2007/0179571) in view of Lim (US 2018/0015301).
Regarding claim 10, Taboada discloses the system of claim 1 as discussed above, but fails to disclose wherein the phototherapy apparatus is configured to set nodes of a brain network for targeted irradiation and irradiation parameters based on functional connection parameters of the brain network of the patient related to Alzheimer's disease.
However, Lim discloses a phototherapy apparatus ([0182] a light-weight, portable transcranial NIR light therapy device) configured to set nodes of a brain network for targeted irradiation and irradiation parameters based on functional connection parameters of the brain network of the patient related to Alzheimer's disease ([0182] targeted treatment of cortical hubs of the DMN at specific locations, as can be seen in FIG. 25. Since the cortical hubs are highly connected with each other (sometimes labelled as “connectomes”), stimulating a few of these major hubs may stimulate the whole network in a holistic manner; [0184] preferably targets the hippocampus and other locations on the ventral side of the forebrain because these anatomical regions are associated with AD).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the phototherapy apparatus being configured to set nodes of a brain network for targeted irradiation and irradiation parameters based on functional connection parameters of the brain network of the patient related to Alzheimer's disease as taught by Lim. Such a modification would yield the predictable results of providing a comprehensive holistic therapeutic effect on the brain because the hubs are highly connected to each other (Lim, [0184]).
Regarding claim 12, the modified Taboada discloses the system of claim 10 as discussed above, but fails to disclose wherein the phototherapy apparatus is further configured to: under the condition that a node of the brain network for targeted irradiation is located deeply inside the brain, irradiate another node, which is easier to irradiate and forms a functional connection with the node located deeply.
However, Lim discloses a phototherapy apparatus being further configured to: under the condition that a node of the brain network for targeted irradiation is located deeply inside the brain ([0236] the left, posterior cingulate gyrus, located very deep (at the midline) from the Left angular gyrus area), irradiate another node (left angular gyrus area), which is easier to irradiate and forms a functional connection with the node located deeply ([0236] C. On the left side of the head, posterior and superior to the borders of the left ear: the targeted brain region is the left angular gyrus area in the lateral, inferior parietal cortex, and optionally the left, posterior cingulate gyrus, located very deep (at the midline) from the Left angular gyrus area; Fig. 25).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the phototherapy apparatus being further configured to: under the condition that a node of the brain network for targeted irradiation is located deeply inside the brain, irradiate another node, which is easier to irradiate and forms a functional connection with the node located deeply as taught by Lim. Such a modification would yield the predictable results of providing a comprehensive holistic therapeutic effect on the brain because the hubs are highly connected to each other (Lim, [0184]).
Regarding claim 13, Taboada discloses emergent average irradiance of the near-infrared light emitted via the light transmittable portion is in the range of 50 mW/cm2 to 250 mW/cm2 [0105], but fails to expressly disclose wherein the emergent average irradiance of the near-infrared light is emitted to a frontal lobe or a temporal lobe.
However, Lim discloses wherein near-infrared light is emitted to target areas including the frontal lobe and temporal lobe ([0182-0184] transcranial NIR light therapy delivered to a preferred set of targets including the brain's precuneus, posterior cingulate cortex, medial prefrontal cortex, middle frontal lobe, hippocampus, parietal lobe and temporal lobe). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the emergent average irradiance of the near-infrared light is emitted to a frontal lobe or a temporal lobe as taught by Lim. Such a modification would yield the predictable results of providing a comprehensive holistic therapeutic effect on the brain because the hubs are highly connected to each other (Lim, [0184]).
Regarding claim 15, Taboada discloses the system of claim 1 as discussed above, but fails to expressly disclose wherein the array of near-infrared irradiation units is constructed to emit near-infrared light to nodes of a brain network related to development of Alzheimer's disease;
or emit near-infrared light to the nodes of the brain network which include at least one of medial prefrontal cortex, medial temporal lobe, cingulate cortex, precuneus, and inferior parietal lobe.
However, Lim discloses wherein the array of near-infrared irradiation units is constructed to emit near-infrared light ([0182] transcranial NIR light therapy) to nodes of a brain network (cortical hubs) related to development of Alzheimer's disease ([0184] targets the hippocampus and other locations on the ventral side of the forebrain because these anatomical regions are associated with AD);
or emit near-infrared light ([0182] transcranial NIR light therapy) to the nodes of the brain network which include at least one of medial prefrontal cortex, medial temporal lobe, cingulate cortex, precuneus, and inferior parietal lobe ([0184] A preferred set of targets for the present invention include but are not limited to the brain's precuneus, posterior cingulate cortex, medial prefrontal cortex, middle frontal lobe, hippocampus, parietal lobe and temporal lobe).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with wherein the array of near-infrared irradiation units is constructed to emit near-infrared light to nodes of a brain network related to development of Alzheimer's disease; or emit near-infrared light to the nodes of the brain network which include at least one of medial prefrontal cortex, medial temporal lobe, cingulate cortex, precuneus, and inferior parietal lobe as taught by Lim. Such a modification would yield the predictable results of providing a comprehensive holistic therapeutic effect on the brain because the hubs are highly connected to each other (Lim, [0184]).
Regarding claim 25, Taboada discloses the system of claim 23 as discussed above, but fails to disclose wherein the near-infrared irradiation unit is a lamp panel carrying a plurality of near-infrared LEDs, and there is a first predetermined spacing between two adjacent near- infrared irradiation units in corresponding regions of a frontal lobe and temporal lobe, such that the projection area of the near-infrared light emitted by each near- infrared LED of one near-infrared irradiation unit on the patient's head covers the projected area of the first predetermined spacing on the patient's head.
However, Lim discloses wherein the near-infrared irradiation unit is a lamp panel (cluster head) carrying a plurality of near-infrared LEDs ([0183] a light frame which supports one or more cluster heads, wherein each cluster head houses one or more light generating units), and
there is a first predetermined spacing between two adjacent near-infrared irradiation units in corresponding regions of a frontal lobe and temporal lobe ([0182] targeted treatment of cortical hubs of the DMN at specific locations, as can be seen in FIG. 25; [0184] A preferred set of targets for the present invention include but are not limited to the brain's precuneus, posterior cingulate cortex, medial prefrontal cortex, middle frontal lobe, hippocampus, parietal lobe and temporal lobe)
such that the projection area of the near-infrared light emitted by each near- infrared LED of one near-infrared irradiation unit on the patient's head covers the projected area of the first predetermined spacing on the patient's head (Fig. 25 shows each cluster covering a projected area; [0233-0237]).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the near-infrared irradiation unit is a lamp panel carrying a plurality of near-infrared LEDs, and there is a first predetermined spacing between two adjacent near- infrared irradiation units in corresponding regions of a frontal lobe and temporal lobe, such that the projection area of the near-infrared light emitted by each near- infrared LED of one near-infrared irradiation unit on the patient's head covers the projected area of the first predetermined spacing on the patient's head as taught by Lim. Such a modification would yield the predictable results of providing a comprehensive holistic therapeutic effect on the brain because the hubs are highly connected to each other (Lim, [0184]).
Claim(s) 14 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada (US 2007/0179571) in view of De Taboada et al (US 2010/0010594) hereinafter De Taboada.
Regarding claim 14, Taboada discloses the system of claim 1 as discussed above, but fails to disclose wherein the phototherapy apparatus is further configured to: based on other psychological disorder of the patient, regulate an irradiation parameter of the near-infrared light irradiated to the patient's brain network nodes related to another psychological disorder, including an average irradiance; or
under the condition that the patient has other psychological disorder, cause the array of the near-infrared irradiation units to emit via the light transmittable portion the near-infrared light to the patient's brain network nodes related to the other psychological disorder, with the emergent average irradiance in the range of 80mW/ cm2 to 250 mW/ cm2.
However, De Taboada discloses wherein the phototherapy apparatus is further configured to: based on other psychological disorder of the patient, regulate an irradiation parameter of the near-infrared light irradiated to the patient's brain network nodes related to another psychological disorder (Claim 29: A therapy apparatus for treating a patient's brain with light to treat at least one of stroke, Parkinson's disease, Alzheimer's disease, and depression, the therapy apparatus comprising: a light source adapted to apply light to at least a portion of the brain, the applied light having an irradiance and wavelength configured to therapeutically treat at least one of stroke, Parkinson's disease, Alzheimer's disease, and depression), including an average irradiance (Claim 35: wherein the irradiance is between about 0.01 mW/cm2 and about 100 mW/ cm2).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with a phototherapy apparatus being further configured to: based on other psychological disorder of the patient, regulate an irradiation parameter of the near-infrared light irradiated to the patient's brain network nodes related to another psychological disorder, including an average irradiance as taught by De Taboada. Such a modification would provide the predictable results of treating depression (claim 29) which can cause disruption in cognitive function and neurodegeneration (De Taboada, [0116]).
Examiner notes that as the claim is currently written, the limitation “under the condition that the patient has other psychological disorder, cause the array of the near-infrared irradiation units to emit via the light transmittable portion the near-infrared light to the patient's brain network nodes related to the other psychological disorder, with the emergent average irradiance in the range of 80mW/ cm2 to 250 mW/ cm2” is claimed in the alternative and is not positively recited. Therefore, the prior art discussed above satisfies the current claim language.
Claim(s) 16 is rejected under 35 U.S.C. 103 as being unpatentable over Taboada (US 2007/0179571) in view of Lim (US 2018/0015301) and further in view of Greicius et al (US 2005/0215884) hereinafter Greicius.
Regarding claim 16, the modified Taboada discloses the system of claim 15 as discussed above but fails to disclose wherein the phototherapy apparatus is further configured to: cause near-infrared irradiation units to emit near-infrared light to the nodes of the brain network, the functional connection strength of which with a hippocampus is weaker than a predetermined level, and a functional connection strength of each node with the hippocampus is determined by cerebral functional imaging of the patient.
Lim discloses wherein the phototherapy apparatus ([0182] transcranial NIR light therapy device) is further configured to: cause near-infrared irradiation units to emit near-infrared light to the nodes of the brain network ([0182] targeted transcranial NIR light therapy of cortical hubs of the DMN at specific locations, as can be seen in FIG. 25), the functional connection strength of which with a hippocampus is weaker than a predetermined level ([0184] preferably targets the hippocampus and other locations on the ventral side of the forebrain because these anatomical regions are associated with AD). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with the phototherapy apparatus being further configured to: cause near-infrared irradiation units to emit near-infrared light to the nodes of the brain network, the functional connection strength of which with a hippocampus is weaker than a predetermined level as taught by Lim. Such a modification would yield the predictable results of providing a comprehensive holistic therapeutic effect on the brain because the hubs are highly connected to each other (Lim, [0184]).
Greicius discloses a functional connection strength of each node with the hippocampus is determined by cerebral functional imaging of the patient ([0005] evaluating the onset or progression of Alzheimer's disease using a non-invasive clinical marker obtained from an independent component analysis (ICA) of an individual's resting state functional MRI). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with a functional connection strength of each node with the hippocampus is determined by cerebral functional imaging of the patient as taught by Greicius. Such a modification would provide the predictable results of non-invasively measuring a progression of Alzheimer’s Disease in a patient (Greicius, Abstract).
Claim(s) 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Taboada (US 2007/0179571) in view of Sverdlov et al (US 11,986,667) hereinafter Sverdlov.
Regarding claim 17, Taboada discloses the system of claim 1 as discussed above, but fails to disclose wherein the hood body has a left convex ear portion and a right convex ear portion, and the left convex ear portion and the right convex ear portion are constructed to extend downwards below a patient's ears, so as to cover a left temporal lobe and a right temporal lobe of the patient, respectively, the left convex ear portion and the right convex ear portion are each provided with near-infrared irradiation units to emit near-infrared light to the covered temporal lobe region.
However, Sverdlov discloses a wearable device (Col. 6, ln 64: wearable device 50) having a left convex ear portion and a right convex ear portion (See annotated Fig. 1), and
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Annotated Fig. 1 shows two arrows pointing to convex portions of wearable device 50
the left convex ear portion and the right convex ear portion are constructed to extend downwards below a patient's ears, so as to cover a left temporal lobe and a right temporal lobe of the patient respectively (Col. 12, ln 3-6: These methods associated with the wearable device 50 may include determining an area of the head to position the wearable device 50 (e.g., the temporal lobe)),
the left convex ear portion and the right convex ear portion are each provided with near-infrared irradiation units to emit near-infrared light to the covered temporal lobe region (Col. 12, ln 5-7: an area of the head to position the wearable device 50 (e.g., the temporal lobe)) to output the infrared and/or red lights; Annotated Fig. 1 shows side illumination panels 54 positioned at each temporal lobe; Col. 7, ln 9-10: side illumination panels).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with a left convex ear portion and a right convex ear portion, and the left convex ear portion and the right convex ear portion are constructed to extend downwards below a patient's ears, so as to cover a left temporal lobe and a right temporal lobe of the patient, respectively, the left convex ear portion and the right convex ear portion are each provided with near-infrared irradiation units to emit near-infrared light to the covered temporal lobe region as taught by Sverdlov. Such a modification would provide the predictable results of providing photobiomodulation and linguistic training simultaneously (Col. 11, ln 65-67).
Regarding claim 18, the modified Taboada discloses the system of claim 17 as discussed above, but fails to disclose wherein the hood body further comprises a forehead portion, and has a curved connecting portion between the forehead portion and the left convex ear portion and the right convex ear portion, so that lower edges of the left convex ear portion, the forehead portion, and the right convex ear portion are connected into a whole in a curved manner, so as to completely cover the left temporal lobe and the right temporal lobe of the patient.
However, Sverdlov discloses wherein a wearable device (Col. 6, ln 64: wearable device 50) comprises a forehead portion (See annotated Fig. 1), and
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Annotated Fig. 1 shows two solid arrows which point to left and right convex ear portions and a dashed arrow which points to a forehead portion
has a curved connecting portion between the forehead portion and the left convex ear portion and the right convex ear portion, so that lower edges of the left convex ear portion, the forehead portion, and the right convex ear portion are connected into a whole in a curved manner, so as to completely cover the left temporal lobe and the right temporal lobe of the patient (Annotated Fig. 1 shows a curved connection portion between the indicated forehead portion and convex ear portions; Col. 12, ln 3-6: These methods associated with the wearable device 50 may include determining an area of the head to position the wearable device 50 (e.g., the temporal lobe); Fig. 2C shows a side view of wearable device 50).
It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Taboada with a forehead portion, and has a curved connecting portion between the forehead portion and the left convex ear portion and the right convex ear portion, so that lower edges of the left convex ear portion, the forehead portion, and the right convex ear portion are connected into a whole in a curved manner, so as to completely cover the left temporal lobe and the right temporal lobe of the patient as taught by Sverdlov. Such a modification would provide the predictable results of providing photobiomodulation and linguistic training simultaneously (Col. 11, ln 65-67).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Maxted et al (US 5,342,411) teaches a scalp cooling device which allows patients to move their head during use (Fig. 1). Shanks (US 2018/0169434) discloses a skull cap for light therapy [0021].
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/WILLOW GRACE WELCH/Examiner, Art Unit 3792
/William J Levicky/Primary Examiner, Art Unit 3796
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