DETAILED ACTION
Response to Amendment
This Office Action is responsive to the Amendment filed 1 July 2026. Claims 1-17 are now pending. The Examiner acknowledges the amendments to claims 1-15, and newly added claims 16 and 17.
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 .
Specification
The abstract of the disclosure is objected to because the abstract exceeds 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 1, 15 are objected to because of the following informalities:
-Claim 1 recites “wherein the control unit” in line 21. Examiner recommends amending to –and wherein the control unit—
-Claim 15 recites “calculating the modified set” in line 23. Examiner recommends amending to –and calculating the modified set—
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
-Claim 1 recites “control unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to control lighting. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 1 recites “input unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to input a set irradiation dose. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 1 recites “storage unit” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is for storing at least one parameter for modifying the set irradiation dose. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 1 recites “modifier” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to modify the set irradiation dose input by the input unit. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
-Claim 1 recites “lighting controller” which is a generic placeholder. There is no sufficient structure for this limitation provided in the claims. The function of this limitation is to cause the LED light source to provide the modified set irradiation dose of the ultraviolet light obtained by the modifier. Based on the specification, there is no disclosure provided to disclose the corresponding structure.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 14 now recite “wherein the reference ultraviolet light is not used for a therapeutic light;” however the claimed subject matter also encompasses “a degree of effect of the reference ultraviolet light on a human body and a degree of effect on the human body caused by the therapeutic ultraviolet light.” This degree of effect on the human body seems to indicate some sort of therapeutic application of ultraviolet light on the subject. The specification does not describe in a manner as indicated in the claims that this reference ultraviolet light is not used for a therapeutic light but rather indicates that this reference light is a calculation of degree of effect of ultraviolet light on a human body [0057]. Therefore, the specification seems to indicate that this reference ultraviolet light is a calculation of light to be applied to the subject however, it does not state that this reference light is separate and distinct from the actual therapeutic ultraviolet light applied for therapeutic purposes.
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 1-17 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 “standard irradiation amount” in lines 6-7. It is unclear what the term standard encompasses and what this term imparts on the claim language. Further clarification should be provided.
-Claim 1 recites “a modifier…for the therapeutic ultraviolet light” in lines 14-16. It is unclear how the modifier, input unit, storage unit are performing the recited functions of modify, input, and obtain in reference to the input, at least one parameter and modified set irradiation dose. It’s also unclear how “referring to…storage unit” is integrated into these limitations and what this limitation imparts on the claim. Further clarification should be provided.
-Claim 1 recites “the set irradiation dose input by the input unit” in line 14. There is insufficient antecedent basis for this limitation in the claim. Should possibly read –the set irradiation dose received by the input unit—
-Claim 11 recites “the at least one parameter related to the reference ultraviolet light” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 12 recites “the at least one parameter related to the reference ultraviolet light emitted from an excimer lamp” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “the at least one parameter related to the reference ultraviolet light source emitted from an LED light source” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “the reference ultraviolet light source” in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
-Claim 13 recites “an LED light source” in line 3. It is unclear whether this is the same or different from the LED light source originally referenced in claim 1, line 2. Further clarification should be provided.
-Claim 14 recites “provide the modified set irradiation dose of the therapeutic ultraviolet light” in lines 13-14. There is insufficient antecedent basis for this limitation in the claim. Should possibly recite –provide the modified set irradiation dose for the therapeutic ultraviolet light—
-Claim 14 recites “standard irradiation amount” in lines 4-5. It is unclear what the term standard encompasses and what this term imparts on the claim language. Further clarification should be provided.
-Claim 14 recites “a reference ultraviolet for a patient” in lines 5-6. It is unclear whether this limitation is referring to a value, light or a separate embodiment. Should possibly read –a reference ultraviolet light for a patient—
Claim limitations “control unit”, “input unit”, “storage unit”, “modifier”, “lighting controller” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. While these terms are referenced in the specification, there is no corresponding structure provided for these limitations. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
Claim Rejections - 35 USC § 102
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 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, 2, 4, 5, 14, 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Livingston (U.S. 20160175610).
Regarding Claim 1, Livingston teaches an ultraviolet therapy apparatus [0038], comprising:
a light source part having an LED light source [Fig. 6, elements 11-14 (light source)] that emits light including ultraviolet light and a light-outputting surface through which the ultraviolet light from the LED light source is output for a therapeutic ultraviolet light to be applied to a patient [Fig. 6, elements 1, 3, 5, 7, 19 (lamp/diode panels)] and [0024]—light therapy device;
a control unit configured to control lighting of the LED light source [Fig. 19, element 9 (input box)];
an input unit configured to receive input of a set irradiation dose [Fig. 19, element 22 (touch screen)], which is a standard irradiation amount of a reference ultraviolet light for the patient, wherein the reference ultraviolet light is not used for a therapeutic light [0065]—includes discussion on calculation of patient absorbed dosage which is interpreted to be a calculation and not the therapeutic light applied to the patient; and
a storage unit for storing at least one parameter for modifying the set irradiation dose to a modified set irradiation dose for the therapeutic ultraviolet light that is output from the light- outputting surface [Fig. 19 , element 21 (SDHD memory)],
the control unit including:
a modifier configured to modify the set irradiation dose input by the input unit referring to the at least one parameter stored in the storage unit to obtain the modified set irradiation dose for the therapeutic ultraviolet light [Fig. 19, element 65 (microprocessor)], and
a lighting controller configured to cause the LED light source to provide the modified set irradiation dose of the therapeutic ultraviolet light obtained by the modifier [Fig 19, element 10 (power switch)],
wherein the modified set irradiation dose is derived from a degree of effect of the reference ultraviolet light on a human body and a degree of effect on the human body caused by the therapeutic ultraviolet light [0011]—operator controlling light emitting device in real time to optimize proper dose and [0128-0129]—refers to exposure calculated as a total for the session,
wherein the control unit is electrically connected to the light source part for driving the LED light source, is electrically connected to the input unit for receiving a signal indicating the set irradiation dose from the input unit, and is electrically connected to the storage unit for retrieving the at least one parameter from the storage unit [0065] and [See annotated Fig. 19 below showing electrical connections between the described parts].
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Regarding Claim 2, Livingston teaches wherein the storage unit stores, as the at least one parameter, a modification factor [0097], which is a value obtained by dividing the degree of effect of the reference ultraviolet light on the human body by the degree of effect of the therapeutic ultraviolet light on the human body [0095-0099]—see reference equation and reference to light reflected by the patient’s body, and
wherein the modifier is configured to calculate the modified set irradiation dose by multiplying the set irradiation dose input by the input unit by the modification factor stored in the storage unit [0100]—see referenced Fitzpatrick number equation.
Regarding Claim 4, Livingston teaches wherein the storage unit stores an irradiance of the therapeutic ultraviolet light to be output from the light-outputting surface [0121],
and wherein the lighting controller is configured to calculate an irradiation time of the ultraviolet light from the LED light source by dividing the modified set irradiation dose by the irradiance of the therapeutic ultraviolet light [Fig. 15, element 88 (exposure time)], and to cause the LED light source to emit the ultraviolet light for the irradiation time [0013]—reference to determining exposure time protocol for future treatment.
Regarding Claim 5, Livingston teaches wherein the lighting controller is configured to calculate an irradiance of the therapeutic ultraviolet light by dividing the modified set irradiation dose by a predetermined irradiation time, and to cause the LED light source to emit the therapeutic ultraviolet light at the irradiance for the predetermined irradiation time [0067]—describes microprocessor under normal conditions, programmed to function with an exposure time and safety mechanisms in place that limit the system if function failure occurs to turn off electrical current to the light sources to prevent injury to the patient.
Regarding Claim 14, Livingston teaches a method for applying ultraviolet light using an ultraviolet therapy apparatus having a light-outputting surface through which light including a therapeutic ultraviolet light emitted from an LED light source is output [0038], [Fig. 6, elements 11-14 (light source)] and [Fig. 6, elements 1, 3, 5, 7, 19 (lamp/diode panels)], comprising:
receiving input of a set irradiation dose, which is a standard irradiation amount of a reference ultraviolet for a patient, wherein the reference ultraviolet light is not used for a therapeutic light [0065]—includes discussion on calculation of patient absorbed dosage which is interpreted to be a calculation and not the therapeutic light applied to the patient;
modifying the set irradiation dose by comparing a degree of effect on a human body by the reference ultraviolet light with a degree of effect on the human body by the therapeutic ultraviolet light to obtain a modified set irradiation dose for the therapeutic ultraviolet light that is to be output from the light- outputting surface [0011]—operator controlling light emitting device in real time to optimize proper dose and [0128-0129]; and
causing the LED light source to provide the modified set irradiation dose of the therapeutic ultraviolet light [0038]—providing safety mechanisms that limit the dosage.
Regarding Claim 16, Livingston teaches wherein modifying the set irradiation dose includes:
calculating the modified set irradiation dose by multiplying the set irradiation dose by a modification factor [0095]—reference to the modification factor “Body Ration”, which is a value obtained by dividing the degree of effect of the reference ultraviolet light on the human body by the degree of effect of the therapeutic ultraviolet light on the human body [0095-0100]—describing the degree of effect of the reference UV light reflected [0098] and the degree of effect of the therapeutic UV light output of the bulbs.
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) 3, 6, 7, 15, 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Livingston (U.S. 20160175610) in view of Ferolito (U.S. 20160129279).
Regarding Claim 3, Livingston is silent on wherein the storage unit stores, as the at least one parameter, a spectrum of the reference ultraviolet light, a spectrum of the therapeutic ultraviolet light, and an erythema action spectrum, and wherein the modifier is configured to calculate the degree of effect of the reference ultraviolet light on the human body by using a product of an intensity distribution in the spectrum of the reference ultraviolet light stored in the storage unit and the erythema action spectrum stored in the storage unit, calculate the degree of effect of the therapeutic ultraviolet light on the human body by using a product of an intensity distribution in the spectrum of the therapeutic ultraviolet light stored in the storage unit and the erythema action spectrum stored in the storage unit, calculate a modification factor, which is a value obtained by dividing the degree of effect of the reference ultraviolet light on the human body by the degree of effect of the therapeutic ultraviolet light on the human body, and calculate the modified set irradiation dose by multiplying the set irradiation dose input by the input unit by the modification factor.
Ferolito teaches wherein the storage unit stores, as the at least one parameter [0042], a spectrum of the reference ultraviolet light [0051]—reference to Fig. 7, a spectrum of the therapeutic ultraviolet light [0051]—reference to Fig. 8, and an erythema action spectrum [0053], and
wherein the modifier is configured to calculate the degree of effect of the reference ultraviolet light on the human body by using a product of an intensity distribution in the spectrum of the reference ultraviolet light stored in the storage unit and the erythema action spectrum stored in the storage unit [0051]—describes effectiveness of these action spectrum of wavelengths near 295 nm,
calculate the degree of effect of the therapeutic ultraviolet light on the human body by using a product of an intensity distribution in the spectrum of the therapeutic ultraviolet light stored in the storage unit and the erythema action spectrum stored in the storage unit [0046]—describes feedback sensors detecting amplitude of emitted light to adjust amplitude and [0054]—which describes how the action-spectrum is used to provide a correct dose of vitamin D based on the UV light exposure method,
calculate a modification factor [0051]—reference to compensating for factors, which is a value obtained by dividing the degree of effect of the reference ultraviolet light on the human body by the degree of effect of the therapeutic ultraviolet light on the human body [0051; “Multiple sensors and/or sensors capable of averaging or viewing a wider area of skin provide protection from single point sampling error.”], and
calculate the modified set irradiation dose by multiplying the set irradiation dose input by the input unit by the modification factor [0051; “Multiple sensors and/or sensors capable of averaging or viewing a wider area of skin provide protection from single point sampling error.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate action-spectrum data as taught by Ferolito to understand changes the UV light is subjecting the body to as suggested by Livingston as Livingston discusses the use of reflectance energy data to control the system to create a medically approvable level of photon energy defined as M.E.D. [0003] with Ferolito because Ferolito teaches that when MED exposure reaches a certain threshold, therapy needs to be stopped [0051].
Regarding Claim 6, Livingston is silent on wherein the degree of effect of the reference ultraviolet light on the human body is an integral value of a product of an intensity distribution in a spectrum of the reference ultraviolet light and an erythema action spectrum over a predetermined wavelength range, and wherein the degree of effect of the therapeutic ultraviolet light on the human body is an integral value of a product of an intensity distribution in a spectrum of the therapeutic ultraviolet light and the erythema action spectrum over the predetermined wavelength range. Ferolito teaches wherein the degree of effect of the reference ultraviolet light on the human body is an integral value of a product of an intensity distribution in a spectrum of the reference ultraviolet light and an erythema action spectrum over a predetermined wavelength range, and wherein the degree of effect of the therapeutic ultraviolet light on the human body is an integral value of a product of an intensity distribution in a spectrum of the therapeutic ultraviolet light and the erythema action spectrum over the predetermined wavelength range [0051]—describing the effectiveness of the device determined by use of MEDs, action spectrum, to determine adjustments that must be made during light therapy for different skin types.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate action-spectrum data as taught by Ferolito to determine adjustments, modifications and compensation factors to control exposure to as suggested by Livingston as Livingston discusses temperature and distance compensations [0070 and 0086] with Ferolito because Ferolito teaches the device responds to wavelength data within the action spectrum to adjust UV light dose and delivery [0053].
Regarding Claim 7, Livingston further teaches wherein the predetermined wavelength range is from 250 nm to 400 nm [0012]—reference to wavelength range of 280-320 nm.
Regarding Claim 15, Livingston is silent on wherein modifying the set irradiation dose includes: measuring a spectrum of the therapeutic ultraviolet light in a predetermined wavelength range; calculating an erythemal ultraviolet irradiance by integrating a product of an intensity distribution in the spectrum of the therapeutic ultraviolet light and an erythema action spectrum over the predetermined wavelength range; calculating a normalized erythemal ultraviolet irradiance by normalizing the erythemal ultraviolet irradiance by an integral value of the spectrum of the therapeutic ultraviolet light over the predetermined wavelength range; measuring a spectrum of the reference ultraviolet light in the predetermined wavelength range; calculating a reference erythemal ultraviolet irradiance by integrating a product of an intensity distribution in the spectrum of the reference ultraviolet light and the erythema action spectrum over the predetermined wavelength range; calculating a normalized reference erythemal ultraviolet irradiance by normalizing the reference erythemal ultraviolet irradiance by an integral value of the spectrum of the reference ultraviolet light over the predetermined wavelength range; calculating a modification factor by dividing the normalized reference erythemal ultraviolet irradiance by the normalized erythemal ultraviolet irradiance; calculating the modified set irradiation dose by multiplying the set irradiation dose by the modification factor.
Ferolito teaches wherein modifying the set irradiation dose includes:
measuring a spectrum of the therapeutic ultraviolet light in a predetermined wavelength range [0051]—reference to Fig. 7;
calculating an erythemal ultraviolet irradiance by integrating a product of an intensity distribution in the spectrum of the therapeutic ultraviolet light and an erythema action spectrum over the predetermined wavelength range [0051]—describing the effectiveness of the device determined by use of MEDs, action spectrum, to determine adjustments that must be made during light therapy for different skin types;
calculating a normalized erythemal ultraviolet irradiance by normalizing the erythemal ultraviolet irradiance by an integral value of the spectrum of the therapeutic ultraviolet light over the predetermined wavelength range [0051]—reference to spectrum weighting for UV exposure to skin;
measuring a spectrum of the reference ultraviolet light in the predetermined wavelength range [0051]—reference to Fig. 7;
calculating a reference erythemal ultraviolet irradiance by integrating a product of an intensity distribution in the spectrum of the reference ultraviolet light and the erythema action spectrum over the predetermined wavelength range [0051]—describing the effectiveness of the device determined by use of MEDs, action spectrum, to determine adjustments that must be made during light therapy for different skin types;
calculating a normalized reference erythemal ultraviolet irradiance by normalizing the reference erythemal ultraviolet irradiance by an integral value of the spectrum of the reference ultraviolet light over the predetermined wavelength range [0051]—describing the effectiveness of the device determined by use of MEDs, action spectrum, to determine adjustments that must be made during light therapy for different skin types;
calculating a modification factor by dividing the normalized reference erythemal ultraviolet irradiance by the normalized erythemal ultraviolet irradiance [0051; “Multiple sensors and/or sensors capable of averaging or viewing a wider area of skin provide protection from single point sampling error.”];
calculating the modified set irradiation dose by multiplying the set irradiation dose by the modification factor [0051; “Multiple sensors and/or sensors capable of averaging or viewing a wider area of skin provide protection from single point sampling error.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate action-spectrum data as taught by Ferolito to understand changes the UV light is subjecting the body to as suggested by Livingston as Livingston discusses the use of reflectance energy data to control the system to create a medically approvable level of photon energy defined as M.E.D. [0003] with Ferolito because Ferolito teaches that when MED exposure reaches a certain threshold, therapy needs to be stopped [0051].
Regarding Claim 17, Livingston is silent on wherein modifying the set irradiation dose includes: calculating the degree of effect of the reference ultraviolet light on the human body by using a product of an intensity distribution in a spectrum of the reference ultraviolet light and an erythema action spectrum, calculating the degree of effect of the therapeutic ultraviolet light on the human body by using a product of an intensity distribution in a spectrum of the therapeutic ultraviolet light and the erythema action spectrum, calculating a modification factor by dividing the degree of effect of the reference ultraviolet light on the human body by the degree of effect of the therapeutic ultraviolet light on the human body, and calculating the modified set irradiation dose by multiplying the set irradiation dose by the modification factor.
Ferolito teaches wherein modifying the set irradiation dose includes:
calculating the degree of effect of the reference ultraviolet light on the human body by using a product of an intensity distribution in a spectrum of the reference ultraviolet light and an erythema action spectrum [0051]—describes effectiveness of these action spectrum of wavelengths near 295 nm,
calculating the degree of effect of the therapeutic ultraviolet light on the human body by using a product of an intensity distribution in a spectrum of the therapeutic ultraviolet light and the erythema action spectrum [0046]—describes feedback sensors detecting amplitude of emitted light to adjust amplitude and [0054]—which describes how the action-spectrum is used to provide a correct dose of vitamin D based on the UV light exposure method,
calculating a modification factor [0051]—reference to compensating for factors, by dividing the degree of effect of the reference ultraviolet light on the human body by the degree of effect of the therapeutic ultraviolet light on the human body [0051; “Multiple sensors and/or sensors capable of averaging or viewing a wider area of skin provide protection from single point sampling error.”], and
calculating the modified set irradiation dose by multiplying the set irradiation dose by the modification factor [0051; “Multiple sensors and/or sensors capable of averaging or viewing a wider area of skin provide protection from single point sampling error.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate action-spectrum data as taught by Ferolito to understand changes the UV light is subjecting the body to as suggested by Livingston as Livingston discusses the use of reflectance energy data to control the system to create a medically approvable level of photon energy defined as M.E.D. [0003] with Ferolito because Ferolito teaches that when MED exposure reaches a certain threshold, therapy needs to be stopped [0051].
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Livingston (U.S. 20160175610) in view of Bennouri (U.S. 9068887).
Regarding Claim 8, Livingston is silent on wherein the degree of effect of the reference ultraviolet light on the human body is a UV index of the reference ultraviolet light, and wherein the degree of effect of the therapeutic light on the human body is a UV index of the therapeutic ultraviolet light. Bennouri teaches wherein the degree of effect of the reference ultraviolet light on the human body is a UV index of the reference ultraviolet light, and wherein the degree of effect of the therapeutic light on the human body is a UV index of the therapeutic ultraviolet light [Abstract; “The UV dosimetry system processes the measured UV irradiance intensity to calculate the UV index (UVI) and the sensor site specific UV dose. It can also calculate the total absorbed UV dose and vitamin D production by taking into account user specific factors.”]
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to UV index data as taught by Bennouri to determine to control UV exposure to as suggested by Livingston as Livingston discusses the use of accurate skin absorption of UV measurements to allow for adjustment based on real-time information [0010] with Bennouri because Bennouri teaches UV index data as an internationally accepted parameter for measuring intensity of UV radiation [Col 1, lines 46-47].
Claim(s) 9, 10, 11, 12, 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Livingston (U.S. 20160175610) in view of Benesol (U.S. 20180056088).
Regarding Claim 9, Livingston is silent on wherein the LED light source is manufactured to emit the therapeutic ultraviolet light having a peak wavelength within a range of 308 nm to 313 nm. Benesol teaches wherein the LED light source is manufactured to emit the therapeutic ultraviolet light having a peak wavelength within a range of 308 nm to 313 nm [Fig. 1] and [0031].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the range of 308 to 313 as taught by Benesol to allow for vitamin D creation as suggested by Livingston as Livingston discusses vitamin D created in the human body by exposure to UVB in the range of 280-320 nm [0012] with Benesol because Benesol teaches the effectiveness of excimer lasers at stimulating depigmentation of melanocytes affected by vitiligo [0032].
Regarding Claim 10, Livingston is silent on wherein the LED light source is manufactured to emit the therapeutic ultraviolet light having a peak wavelength at 308 nm. Benesol teaches wherein the LED light source is manufactured to emit the therapeutic ultraviolet light having a peak wavelength at 308 nm [Fig. 1] and [0031].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the range of 308 to 313 as taught by Benesol to allow for vitamin D creation as suggested by Livingston as Livingston discusses vitamin D created in the human body by exposure to UVB in the range of 280-320 nm [0012] with Benesol because Benesol teaches the effectiveness of excimer lasers at stimulating depigmentation of melanocytes affected by vitiligo [0032].
Regarding Claim 11, Livingston is silent on wherein the storage unit stores the at least one parameter related to the reference ultraviolet light having a peak wavelength within a range of 308 nm and 313 nm. Benesol teaches wherein the storage unit stores the at least one parameter related to the reference ultraviolet light having a peak wavelength within a range of 308 nm and 313 nm [Fig. 1] and [0031].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the range of 308 to 313 as taught by Benesol to allow for vitamin D creation as suggested by Livingston as Livingston discusses vitamin D created in the human body by exposure to UVB in the range of 280-320 nm [0012] with Benesol because Benesol teaches the effectiveness of excimer lasers at stimulating depigmentation of melanocytes affected by vitiligo [0032].
Regarding Claim 12, Livingston is silent on wherein the storage unit stores the at least one parameter related to the reference ultraviolet light emitted from an excimer lamp. Benesol teaches wherein the storage unit stores the at least one parameter related to the reference ultraviolet light emitted from an excimer lamp [0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the range of 308 to 313 as taught by Benesol to allow for vitamin D creation as suggested by Livingston as Livingston discusses vitamin D created in the human body by exposure to UVB in the range of 280-320 nm [0012] with Benesol because Benesol teaches the effectiveness of excimer lasers at stimulating depigmentation of melanocytes affected by vitiligo [0032].
Regarding Claim 13, Livingston is silent on wherein the storage unit stores the at least one parameter related to the reference ultraviolet light source emitted from an LED light source. Benesol teaches wherein the storage unit stores the at least one parameter related to the reference ultraviolet light source emitted from an LED light source [0031-0032].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to specify the range of 308 to 313 as taught by Benesol to allow for vitamin D creation as suggested by Livingston as Livingston discusses vitamin D created in the human body by exposure to UVB in the range of 280-320 nm [0012] with Benesol because Benesol teaches the effectiveness of excimer lasers at stimulating depigmentation of melanocytes affected by vitiligo [0032].
Response to Arguments
Applicant's arguments filed 01 July 2026 with respect to the abstract objections have been fully considered but are not persuasive. The abstract exceeds 150 words and requires amendment.
Applicant's arguments filed 01 July 2026 with respect to the claim objections have been fully considered and are persuasive however, new objections are presented in light of the amendments.
Applicant's arguments filed 1 July 2026 with respect to 35 U.S.C. 112(b)
rejections have been fully considered however, those rejections for claim 1 under 35 U.S.C. 112(b) in light of claim interpretation under 35 U.S.C. 112(f) are maintained. While the applicant contends that structural relationships among the recited components are recited, the claims merely recite electrical connections between such components and do not identify what these components are. In view of the foregoing, the 35 U.S.C. 112(b) rejection is maintained.
Applicant’s arguments filed 1 July 2026 with respect to the rejection of
claims 1 and 14 under 35 U.S.C.102(a)(1) have been fully considered but are not persuasive. Applicant contends that amended independent claims recite a reference ultraviolet light that is not actually used for therapy, modifying a set irradiation dose to be emitted by an LED light source that is actually used for therapy. While the amended limitations do contain indication that the reference ultraviolet light is not used for a therapeutic light, the examiner notes that in the rejection, the referenced paragraph [0065] discusses the calculation of a UV dosage which would not include therapeutic application but rather computation/calculation of a theoretical value to be absorbed by the patient. In view of the foregoing, the 35 U.S.C. 102(a)(1) rejection of claims 1, 2, 4, 5, 14 and newly added claim 16 citing Livingston is maintained.
Applicant’s arguments filed 1 July 2026 with respect to the rejection of
claims 2-13 and 15 and 17 under 35 U.S.C.103 have been fully considered but are not persuasive. In view of the discussed argument in the preceding paragraph, the 35 U.S.C. rejection for claims 3, 6, 7, 15 and 17 citing Livingston in view of Ferolito, for claim 8 citing Livingston in view of Bennouri, for claims 9-13 citing Livingston in view of Benesol, are maintained.
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.
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/B.N.K./Examiner, Art Unit 3791
/CHRISTINE H MATTHEWS/Primary Examiner, Art Unit 3791
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