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 2, 8, 12, 18 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.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “mW/cm2-cm” in claims 2, 8, 12, 18 is used by the claim to mean “a measure of optical radiant power density,” while the accepted unit for measuring optical radiant power density is “mW/cm2.”; see Wikipedia “Irradiance” (https://en.wikipedia.org/wiki/Irradiance); and Edmund Optics “Laser Power Density versus Energy Density” (https://www.edmundoptics.com/knowledge-center/application-notes/lasers/laser-power-density-versus-energy-density/?srsltid=AfmBOoqdy7HSNtsDuqYQy81wmkpM6QyPTpkwu9PoPrHMLw0DQSYqQcN5; “In most scientific disciplines, including chemistry and electrical engineering, “power density” and “energy density” typically describe a three-dimensional volume. However, in optical sciences the terms are typically used to describe a two-dimensional area, unless described as “volumetric.” Power density, energy density, fluence, and irradiance are often used interchangeably in the optics industry”); the standard SI unit of irradiance or optical power density is in W/m2; it is unknown what the extra “-cm” in the denominator in instant claims as well as instant specification (e.g. [8]) signify; it would not make sense to a person of ordinary skill in the art for power density to be measured over units of volume as opposed to the standard surface area without an explicit description of “volumetric”. The term is indefinite because the specification does not clearly redefine the term. For examination purposes below, it will be assumed the standard unit of over surface area is meant; W/cm2 as is standard within the phototherapy arts.
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 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, 4, 5, 7, 11, 14, 15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou (CN 104147705 A; 11/19/2014; cited in IDS; English translation relied upon) in view of Decaux (US 20180071547 A1; 3/15/2018), and further in view of Shanks (US 20060229690 A1; 10/12/2006).
Regarding claim 1, Hou teaches a phototherapy device configured to supply light energy to an ATP energy metabolism process in intracellular mitochondria ([0003]; [0006]), the phototherapy device comprising:
a red light emitting diode configured to output red light ([0015]-[0016]).
Hou does not teach having a peak wavelength of 660 nm±2%. However, Decaux teaches in the same field of endeavor (Abstract; [0123]) having a peak wavelength of 660 nm±2% ([0034]; [0133] “630”). 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 Hou to include this feature as taught by Decaux because this is a suitable light wavelength to use for phototherapy ([0034]; [0123]).
In the combination of Hou and Decaux, Hou teaches a red light driving unit configured to drive the red light emitting diode (Fig. 1; Fig. 3; Fig. 5; [0019]-[0020]; [0035]); and
a controller comprising a red light control unit configured to output a driving pulse train having a pulse period (Fig. 1; Fig. 3-5; [0017]-[0020]; [0043]-[0045] “randomly”; [0048]).
The combination of Hou and Decaux does not teach a pulse period randomly determined within a first range during a pulse fluctuation period to the red light driving unit. However, Shanks teaches in the same field of endeavor (Fig. 7; Fig. 9a-9f) a pulse period randomly determined within a first range during a pulse fluctuation period to the red light driving unit (Fig. 9a-9f; [0033]; random pulse frequencies read on the instant limitation). 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 Hou and Decaux to include this feature as taught by Shanks because this enables a better therapeutic response to the light treatment ([0005]; [0033]).
Claim 11 is rejected under substantially the same basis as claim 1 above.
Regarding claim 4, in the combination of Hou, Decaux, and Shanks, Hou teaches wherein the red light control unit is configured such that the driving pulse train output during the pulse fluctuation period has a duty ratio randomly determined within a third range ([0020]; [0043]; [0045] “duty ratio…randomly”; [0048]-[0051]).
Claim 14 is rejected under substantially the same basis as claim 4 above.
Regarding claim 5, the combination of Hou, Decaux, and Shanks teaches a near-infrared light emitting diode configured to radiate near-infrared light having a peak wavelength of 830 nm±2% (Decaux [0133] “peaks…830 nm”); and
a near-infrared light driving unit configured to drive the near-infrared light emitting diode, wherein the controller further comprises a near-infrared light control unit configured to output a driving pulse train having a pulse period randomly determined within a third range during the pulse fluctuation period (Decaux [0102]; [0150]; Hou Fig. 1; Fig. 3; Fig. 5; [0017]-[0020]; [0035]; ]; [0043]-[0045] “randomly”; [0048]; Shanks Fig. 9a-9f; [0033]; random pulse frequencies read on the instant limitation).
Claim 15 is rejected under substantially the same basis as claim 5 above.
Regarding claim 7, the combination of Hou, Decaux, and Shanks teaches wherein the near-infrared light control unit is configured such that the driving pulse train output during the pulse period has a duty ratio randomly determined within a fifth range (Decaux [0133] “peaks…830 nm”; Hou [0020]; [0043]; [0045] “duty ratio…randomly”; [0048]-[0051]).
Claim 17 is rejected under substantially the same basis as claim 7 above.
Claim(s) 2, 8, 12, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou, Decaux, and Shanks as applied to claims 1, 5, 11, 15 above, and further in view of Lay (US 20210370090 A1; 12/2/2021).
Regarding claim 2, the combination of Hou, Decaux, and Shanks does not teach wherein the red light control unit is configured to generate the driving pulse train such that an optical radiant power density of the light output by the red light emitting diode is within a range of 20 to 100 mW/cm2-cm. However, Lay teaches in the same field of endeavor (Abstract; [0004]; [0194]; [0217]) wherein the red light control unit is configured to generate the driving pulse train such that an optical radiant power density of the light output by the red light emitting diode is within a range of 20 to 100 mW/cm2-cm ([0176]; [0194]; [0196]). 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 Hou, Decaux, and Shanks to include this feature as taught by Lay because this provides therapeutic benefits ([0003]; [0012]).
Claim 12 is rejected under substantially the same basis as claim 2 above.
Regarding claim 8, the combination of Hou, Decaux, and Shanks does not teach wherein the near-infrared light control unit is configured to generate the driving pulse train such that an optical radiant power density of the light output by the near-infrared light emitting diode is within a range of 20 to 100 mW/cm2-cm. However, Lay teaches in the same field of endeavor (Abstract; [0004]; [0194]; [0217]) wherein the near-infrared light control unit is configured to generate the driving pulse train such that an optical radiant power density of the light output by the near-infrared light emitting diode is within a range of 20 to 100 mW/cm2-cm ([0104]; [0217] “830 nm”; [0176]; [0194]; [0196]). 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 Hou, Decaux, and Shanks to include this feature as taught by Lay because this provides therapeutic benefits ([0003]; [0012]).
Claim 18 is rejected under substantially the same basis as claim 8 above.
Claim(s) 3, 6, 13, 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou, Decaux, and Shanks as applied to claims 1, 5, 11, 15 above, and further in view of Daffer (US 20100010591 A1; 1/14/2010).
Regarding claim 3, the combination of Hou, Decaux, and Shanks does not teach wherein the red light control unit is configured to output an off signal during a rest interval having a random value within a second range as a period between the pulse fluctuation period and a next pulse fluctuation period. However, Daffer teaches in the same field of endeavor (Abstract; [0002]) wherein the red light control unit is configured to output an off signal during a rest interval having a random value within a second range as a period between the pulse fluctuation period and a next pulse fluctuation period ([0019] “vary and randomize the amount of treatment and the intensity of the treatment and the pulsation or continuous application of the light exposure over periods of time through a treatment cycle.”; [0020]; varying and randomizing the amount of light exposure treatment via pulsation over periods of time through a treatment cycle reads on recited limitation). 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 Hou, Decaux, and Shanks to include this feature as taught by Daffer because this provides therapeutic benefit ([0020]).
Claim 13 is rejected under substantially the same basis as claim 3 above.
Regarding claim 6, the combination of Hou, Decaux, and Shanks does not teach wherein the near-infrared light control unit is configured to output an off signal during a rest interval having a random value within a fourth range as a period between the pulse fluctuation period and a next pulse fluctuation period. However, Daffer teaches in the same field of endeavor (Abstract; [0002]) wherein the light control unit is configured to output an off signal during a rest interval having a random value within a fourth range as a period between the pulse fluctuation period and a next pulse fluctuation period ([0019] “vary and randomize the amount of treatment and the intensity of the treatment and the pulsation or continuous application of the light exposure over periods of time through a treatment cycle.”; [0020]; varying and randomizing the amount of light exposure treatment via pulsation over periods of time through a treatment cycle reads on recited limitation). 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 Hou, Decaux, and Shanks to include this feature as taught by Daffer because this provides therapeutic benefit ([0020]).
Claim 16 is rejected under substantially the same basis as claim 6 above.
Claim(s) 9, 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hou, Decaux, and Shanks as applied to claim(s) 5, 15 above, and further in view of O'Neil (US 20100196343 A1; 8/5/2010).
Regarding claim 9, the combination of Hou, Decaux, and Shanks does not teach a light radiation management unit configured to control the red light control unit and the near-infrared light control unit in order to limit a duration of irradiation to the same patient in a single treatment and the number of treatments per day. However, O'Neil teaches in the same field of endeavor (Abstract; Fig. 1) a light radiation management unit configured to control the light control unit in order to limit a duration of irradiation to the same patient in a single treatment and the number of treatments per day ([0097]). 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 Hou, Decaux, and Shanks to include this feature to control the red and near-infrared lights because this ensures safe and controlled use of the treatment device by the user ([0097]).
Claim 19 is rejected under substantially the same basis as claim 9 above.
Allowable Subject Matter
Claim(s) 10, 20 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 10 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the light radiation management unit controls the red light control unit and the near-infrared light control unit such that the total energy of the near-infrared light is 1.5 to 2.5 times higher than the total energy of the red light radiated to the same patient per day.
The prior art of record does not disclose or fairly suggest either singly or in combination the claimed invention of dependent claim 20 when taken as a whole, comprising, in addition to the other recited claim elements, wherein the method performs control such that the total energy of the near-infrared light is 1.5 to 2.5 times higher than the total energy of the red light radiated to the same patient per day.
Conclusion
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