Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on 7/18/2025. As directed by the amendment, the status of the claim(s) are:
Claim(s) 1-3, 5-11, 13-14 has/have been amended;
Claim(s) 4 is/are cancelled;
Claim(s) 1-3, 5-15 is/are presently pending;
Claim(s) 1-3, 11-14 is/are rejected;
Claim(s) 5-10, 15 is/are allowed.
The amendment(s) to the claim(s) is sufficient to obviate the 35 U.S.C. 112(f) interpretation(s) from the previous office action(s).
The amendment(s) to the claim(s) is sufficient to overcome the 35 U.S.C. 101 rejection(s) from the previous office action.
Response to Arguments
With regard to claim rejections under 35 USC 102 and/or 103, Applicant’s arguments have been fully considered but are moot in light of new grounds of rejection due to claim amendment(s).
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.
Claim(s) 1-3, 11-14 is/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 "the eyelid opening/closing determiner" in second to last line. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the eyelid opening/closing determiner" in line 14. There is insufficient antecedent basis for this limitation in the claim. Note that line 21 also recites “the eyelid opener/closing determiner” and Applicant Remarks p. 7 discussed how claim amendments were made to avoid 112f interpretation.
For examination purposes below, this element will be interpreted as part of controller.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wells (US 20110257712 A1; 10/20/2011; cited in previous office action) in view of Colbaugh (US 20160158486 A1; 6/9/2016).
Regarding claim 1, Wells teaches a light irradiation system comprising:
an irradiator configured to irradiate an eye of a subject with irradiation light having a predetermined wavelength band (Fig. 1; Fig. 3; Fig. 6; [0014]-[0015]; [0052]); and
a shield positioned between the subject and the irradiator (Fig. 1-3; [0029]; [0066] “blocking some or all of the light therapy radiation”);
a light receiver configured to detect an intensity of return light of the irradiation light (Fig. 5; [0052]-[0053]; [0056]);
a controller electrically coupled to the irradiator and the light receiver (Fig. 4-5), the controller configured to:
receive the intensity to return light from the receiver (Fig. 5; [0052]-[0053]; [0056]),
determine an open/closed state of an eyelid of the subject based on the intensity of the return light (Fig. 5-6; [0052]-[0053]; [0056]); and
control the irradiator to increase an intensity of the irradiation light when the eyelid of the subject is in a closed state to be higher than the intensity of the irradiation light when the eyelid of the subject is an open state (Fig. 5-6; [0056]).
Wells does not teach the irradiator irradiates irradiation light with an intensity of 4 to 100 Lux. However, Colbaugh teaches in the same field of endeavor (Abstract; Fig. 1-3; [0004]) the irradiator irradiates irradiation light with an intensity of 4 to 100 Lux ([0055] “20 to 30 lux”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Wells to include this feature as taught by Colbaugh because this is an appropriate range for treatment ([0055]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
The combination of Wells and Colbaugh teaches when the eyelid opening/closing determiner determines that the eyelid of the subject is in the open state (Wells Fig. 5-6; [0056]; Colbaugh [0055] “20 to 30 lux for open eyes”; [0061] “whether the eyes of the subject 106 are opened or closed”).
Regarding claim 12, in the combination of Wells and Colbaugh, Wells teaches wherein the predetermined wavelength band is either from 450 nm to 600 nm ([0072] “about 580 nm”; MPEP 2131.03: A specific example in the prior art which is within a claimed range anticipates the range) and/or from 350 nm to 410 nm.
Regarding claim 13, the combination of Wells and Colbaugh teaches a wearable device adapted to be worn on a head of a subject (Wells Fig. 1-3), comprising:
the light irradiation system of claim 1 (see above regarding claim 1).
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wells and Colbaugh as applied to claim 1 above, and further in view of Tedford (US 20160067086 A1; 3/10/2016; cited in IDS; cited in previous office action).
Regarding claim 2, the combination of Wells and Colbaugh does not teach an imager configured to capture an image of the eye of the subject; and
a display configured to display the image of the eye of the subject captured by the imager;
wherein the controller is further configured to control the irradiator to change a position of the irradiator with respect to a position of the eye of the subject.
However, Tedford teaches in the same field of endeavor (Abstract; [0003]; [0040]) an imager configured to capture an image of the eye of the subject (Fig. 7, 754; [0061]); and
a display configured to display the image of the eye of the subject captured by the imager (Fig. 3A, 108; Fig. 7, 708; [0061]);
wherein the controller is further configured to control the irradiator to change a position of the irradiator with respect to a position of the eye of the subject (Fig. 3A, 114; Fig. 4; Fig. 6A-6C; Fig. 8; [0062]).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Wells and Colbaugh to include these features as taught by Tedford because this enables delivering light in a targeted manner ([0040]; [0077]).
Regarding claim 3, in the combination of Wells, Colbaugh, and Tedford, Tedford teaches wherein the controller is further configured to control the irradiator to change the position of the irradiator to a position at which the irradiation light is allowed to be directed toward a pupil of the eye of the subject (Fig. 3A, 114; Fig. 4; Fig. 6A-6C; Fig. 8; [0062]; [0077]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wells and Colbaugh as applied to claim 1 above, and further in view of Olds (US 20130301034 A1; 11/14/2013; cited in previous office action).
Regarding claim 11, the combination of Wells and Colbaugh does not teach wherein the controller is further configured to measure an intensity of the irradiation light emitted to the eye of the subject and cumulative time of irradiation; and
the controller is further configured to output information indicating a measured intensity of the irradiation light and information indicating a measured cumulative time of irradiation.
However, Olds teaches in the same field of endeavor ([0002]-[0003]; [0008]) wherein the controller is further configured to measure an intensity of the irradiation light emitted to the eye of the subject and cumulative time of irradiation ([0007]-[0008]; [0038]); and
the controller is further configured to output information indicating a measured intensity of the irradiation light and information indicating a measured cumulative time of irradiation ([0007]-[0008]; [0038]).
Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Wells and Colbaugh to include these features as taught by Olds because enables monitoring light therapy as it progresses ([0007]-[0008]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tedford (US 20160067086 A1; 3/10/2016; cited in IDS; cited in previous office action) in view of Wells (US 20110257712 A1; 10/20/2011; cited in previous office action), and further in view of Colbaugh (US 20160158486 A1; 6/9/2016).
Regarding claim 14, Tedford teaches an installation-type light irradiation device comprising:
a support configured to support a subject in a sitting or lying position (Fig. 2; [0063]);
an irradiator configured to irradiate an eye of the subject with irradiation light having a predetermined wavelength band (Fig. 2; Fig. 8; [0068]).
Tedford does not explicitly teach a shield positioned between the subject and the irradiator. Note that Tedford does depict a shield (Fig. 1B, 104; there is a shield depicted on the left eyepiece of Fig. 1B) but does not describe it. However, for the sake of clarity of the record and to avoid doubt, Wells teaches in the same field of endeavor (Abstract; Fig. 1; Fig. 6) a shield positioned between the subject and the irradiator (Fig. 1-3; [0029]; [0066] “blocking some or all of the light therapy radiation”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Tedford to include this feature as taught by Wells because this enables control of light irradiation delivered to eyes ([0066]).
The combination of Tedford and Wells teaches a light receiver configured to detect an intensity of return light of the irradiation light (Tedford [0040] “camera”; [0077]; [0099]-[0100]; [0106]);
a controller electrically coupled to the irradiator and the light receiver (Tedford Fig. 7), the controller configured to:
receive the intensity of return light from the receiver (Tedford [0040] “camera”; [0077]; [0099]-[0100]; [0106]),
determine an open/closed state of an eyelid of the subject based on the intensity of the return light (Tedford [0040]; [0077]; [099]-[0100]; [0106]); and
control the irradiator to increase an intensity of the irradiation light when the eyelid of the subject is in a closed state to be higher than the intensity of the irradiation light when the eyelid of the subject is in an open state based on a determination result by the eyelid opening/closing determiner (Tedford [0100]), wherein
the irradiator is disposed in the shield at a position opposite to the eye of the subject (Tedford Fig. 1B left eyepiece; Wells Fig. 1-3; [0029]; [0066] “blocking some or all of the light therapy radiation”).
The combination of Tedford and Wells does not teach the irradiator irradiates irradiation light with an intensity of 4 to 100 Lux. However, Colbaugh teaches in the same field of endeavor (Abstract; Fig. 1-3; [0004]) the irradiator irradiates irradiation light with an intensity of 4 to 100 Lux ([0055] “20 to 30 lux”). Thus it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the teaching of Tedford and Wells to include this feature as taught by Colbaugh because this is an appropriate range for treatment ([0055]). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
The combination of Tedford, Wells, and Colbaugh teaches when the eyelid opening/closing determiner determines that the eyelid of the subject is in the open state (Tedford Fig. 7-8; [0040]; [0100]; Wells Fig. 5-6; [0056]; Colbaugh [0055] “20 to 30 lux for open eyes”; [0061] “whether the eyes of the subject 106 are opened or closed”).
Allowable Subject Matter
Claim(s) 5-10, 15 is/are allowed.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 5 and dependents when taken as a whole, comprising, in addition to the other recited claim elements, when the closed state of the eyelid of the subject continues for less than a predetermined time, the light intensity adjuster does not increase the intensity of the irradiation light.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 7 and dependents when taken as a whole, comprising, in addition to the other recited claim elements, wherein the controller is further configured to
continuously irradiate the eye of the subject with the irradiation light having a predetermined intensity for a certain period of time,
acquire a first intensity of the return light detected when the eyelid of the subject is in the open state and a second intensity of the return light detected when the eyelid of the subject is in the closed state, and
determine, based on a comparison result between the first intensity and the second intensity, a first reference intensity of the irradiation light when the eyelid of the subject is in the open state and a second reference intensity of the irradiation light when the eyelid of the subject is in the closed state.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of claim 15 when taken as a whole, comprising, in addition to the other recited claim elements, calibrating by irradiating an eye of a subject with irradiation light having a predetermined intensity for a certain period of time,
acquiring a first intensity of return light detected when an eyelid of the subject is in an open state and a second intensity of the return light detected when the eyelid of the subject is in a closed state, and
determining a first reference intensity of the irradiation light when the eyelid of the subject is in the open state and a second reference intensity of the irradiation light when the eyelid of the subject is in the closed state based on a comparison result between the first intensity and the second intensity;
emitting the irradiation light having the first reference intensity;
changing an intensity of the irradiation light from the first reference intensity to the second reference intensity upon a determination as to whether the eyelid of the subject is in the closed state and whether a predetermined time has passed in the closed state; and
changing the intensity of the irradiation light from the second reference intensity to the first reference intensity upon determination as to whether the eyelid of the subject is in the open state.
See previous non-final office action of 5/1/2025 for more discussion on closest prior art of record for the above allowable subject matter.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792