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 § 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, 5, 8-10, 12, and 15 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.
Claim 1 recites the limitation "activate the OPN5 gene" in line 7. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "activate an OPN5 gene" and suggests amending.
Claim 5 recites the limitation “light source installed in front of or near a face via eyeglasses with the light source, goggles with the light source” in lines 3-4. This limitation is unclear and confusing. Examiner does not understand if the light source is installed on eyeglasses, goggles, or both. Examiner will interpret as “light source installed in front of or near a face via eyeglasses with the light source or goggles with the light source” and suggests amending
Claim 8 recites the limitation "activate the OPN5 gene" in line 8. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "activate an OPN5 gene" and suggests amending.
Claim 9-10, 12, and 15 are rejected based on their dependency on claim 8.
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) 1, 5, 8-10, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0133507 Malchano et al., hereinafter “Malchano”, in view of US 2018/0043130 Moore-Ede et al., hereinafter “Moore”.
Regarding claim 1, Malchano discloses a device (Figure 1, element 100 and Figure 4A, element 400, which represents element 150) for preventing, improving, or preventing a worsening of depression (Para 4 and 988; Examiner highly suggests moving this limitation out of the preamble and positively reciting it to give it patentable weight, with the term “depression” being in the preamble, therefore not carrying patentable weight, examiner is able to apply any reference that provides the therapy to treat any given disease or disorder), the device comprising:
a light source (Figure 4A, elements 305) configured to irradiate at least one eye of a subject (Para 258; “The light source 305 can be positioned to transmit light pulses into the direct visual field 310 or 320 of a person's eyes.”) with violet light (Para 249 and 261 disclose the violet and ultraviolet ranges) having a wavelength range that includes 380 nm (Para 249; “violet (e.g., 380-450 nm)” or “ultra-violet (e.g., 10-380 nm)”) as pulsed light (Para 258; “The light source 305 can be positioned to transmit light pulses into the direct visual field 310 or 320 of a person's eyes.”); and
a controller (Para 37 and 247 and Figure 1, element 115) configured to control the light source to perform irradiation with the pulsed light (Para 289 and 258) for a daily irradiation (Para 950) over 5 to 7 consecutive days (Para 687 discloses 5-7 treatments per week, Para 950 discloses daily treatments) to express or activate an OPN5 gene in a retina of the at least one eye to prevent, improve, or prevent the worsening of depression (This limitation is intended use, Para 266 discloses “the light source 305 can be configured to project light pulses towards the person's eyes if their eyelids are closed such that the light pulse penetrates the eyelid to be perceived by the retina”, which shows the light shining onto the retina).
Malchano does not explicitly disclose a daily irradiation time of 2 hours and 30 minutes to 3 hours and 30 minutes per day over 5 to 7 consecutive days
However, Moore discloses a lighting system that helps treat disorders (Abstract and Para 84 and 115) and teaches a daily irradiation time of 2 hours and 30 minutes to 3 hours and 30 minutes per day (Para 151; the range 3 hours to 3 hours and 30 minutes is disclosed, it is important to note that Moore discloses a violet wavelength Para 49) over 5 to 7 consecutive days (Para 151 and 271; this is used as a user’s daily routine, therefore it is used for 5-7 consecutive days)
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the irradiation time as taught by Moore, in the invention of Malchano, in order to provide protection from the disruption of the circadian timing system and may reduce the suppression of melatonin release (Moore; Para 151).
Regarding claim 5, Malchano discloses the light source (Figure 4A, elements 305) installed in front of or near a face via eyeglasses with the light source or goggles with the light source (Figure 4A shows eyeglasses 400).
Regarding claim 8, Malchano discloses a method for preventing, improving, or preventing a worsening of depression (Abstract, Para 4 and 988; Examiner highly suggests moving this limitation out of the preamble and positively reciting it to give it patentable weight, with the term “depression” being in the preamble, therefore not carrying patentable weight, examiner is able to apply any reference that provides the therapy to treat any given disease or disorder), the method comprising:
irradiating, by a light source (Figure 4A, elements 305), at least one eye of a subject (Para 258; “The light source 305 can be positioned to transmit light pulses into the direct visual field 310 or 320 of a person's eyes.”) with violet light (Para 249 and 261 disclose the violet and ultraviolet ranges) having a wavelength range that includes 380 nm (Para 249; “violet (e.g., 380-450 nm)” or “ultra-violet (e.g., 10-380 nm)”) as pulsed light (Para 258; “The light source 305 can be positioned to transmit light pulses into the direct visual field 310 or 320 of a person's eyes.”);
controlling, by a controller (Para 37 and 247 and Figure 1, element 115), the light source to perform the irradiating (Para 289 and 258; note that “to perform” is an intended use limitation); and
performing the irradiating by the light source (Para 289 and 258) for a daily irradiation (Para 950) over 5 to 7 consecutive days (Para 687 discloses 5-7 treatments per week, Para 950 discloses daily treatments) to express or activate an OPN5 gene in a retina of the at least one eye to prevent, improve, or prevent the worsening of depression (This limitation is intended use, Para 266 discloses “the light source 305 can be configured to project light pulses towards the person's eyes if their eyelids are closed such that the light pulse penetrates the eyelid to be perceived by the retina”, which shows the light shining onto the retina).
Malchano does not explicitly disclose a daily irradiation time of 2 hours and 30 minutes to 3 hours and 30 minutes per day over 5 to 7 consecutive days
However, Moore discloses a lighting system/method that helps treat disorders (Abstract and Para 84 and 115) and teaches a daily irradiation time of 2 hours and 30 minutes to 3 hours and 30 minutes per day (Para 151; the range 3 hours to 3 hours and 30 minutes is disclosed, it is important to note that Moore discloses a violet wavelength Para 49) over 5 to 7 consecutive days (Para 151 and 271; this is used as a user’s daily routine, therefore it is used for 5-7 consecutive days)
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the irradiation time as taught by Moore, in the invention of Malchano, in order to provide protection from the disruption of the circadian timing system and may reduce the suppression of melatonin release (Moore; Para 151).
Regarding claim 9, Malchano discloses an irradiance of the violet light at an ocular surface of the subject (Para 243, 249, and 259).
Malchano does not disclose an irradiance of the violet light is within a range of 0.5 to 1000 μW/cm2.
However, Moore teaches an irradiance of the violet light is within a range of 0.5 to 1000 μW/cm2 (Para 220; note that 430-490nm is within the violet wavelength).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have disclosed the irradiance as taught by Moore, in the invention of Malchano, in order to entrain the circadian system or to avoid circadian phase shifting or melatonin suppression (Moore; Para 220).
Regarding claim 10, Malchano discloses a blinking frequency of the pulsed light is 40 Hz (Para 254 and 284).
Regarding claim 12, Malchano discloses at least one irradiation condition selected from one of an irradiation state, an irradiance, an irradiation time, an irradiation start time, or an irradiation end time is changed (Para 289) by transmission and reception with an isolation controller including a mobile terminal (Para 280, 323, and 352).
Regarding claim 15, Malchano discloses the light source (Figure 4A, elements 305) is installed in front of or near a face via eyeglasses with the light source or goggles with the light source (Figure 4A shows eyeglasses 400).
Response to Arguments
Applicants’ arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Kindly refer to the U.S.C. 112(b) and 103 rejections above for the newly rejected claimed limitations.
Although the prior art has been changed, examiner would like to address applicant’s argument stating “Moore-Ede's references to depression are merely examples of health effects associated with circadian disruption and low levels of nocturnal melatonin, rather than a disclosure of a specific MDD treatment device or protocol […] This rationale is, however does not provide a sufficiently specific motivation for a person of ordinary skill to modify Moore-Ede's ambient-lighting control system into a depression-treatment protocol using OPN5-related violet light”. Examiner stated in the rejection above and further states here that the limitations regarding treatment of depression and expressing or activating an OPN5 gene are merely stated as intended use limitations. The claim discloses “a controller configured to control the light source to perform irradiation […] to express or activate the OPN5 gene in a retina of the at least one eye to prevent, improve, or prevent the worsening of depression.” The claimed “express or activate the OPN5 gene” or the “prevent, improve, or prevent the worsening of depression” are not positively recited. Examiner suggests using “configured to” language to positively recite the limitations to overcome reference Moore.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/Benjamin J Klein/ Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights