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 .
Status of Claims
Claims 1-26 are currently pending and under examination. As per the amendments filed on 06/23/2026, claims 1-2, 5-7, 11-13, 15, 20-21, and 23 are amended and claims 24-26 are newly added.
Priority
The instant application (filed on 10/18/2023) is a national stage of PCT/IB2022/053653 (filed on 04/19/2022), filed under 35 USC 371. Acknowledgment is made of Applicant's claim for foreign priority based on an application CH 00425/21 filed on 04/21/2021. The Examiner used an English translation of the published CH 718557 A1 from Espacenet (see previously attached) to interpret the matching foreign application in the filed certified priority document. Instant claims 1-26 are adequately supported in this translated disclosure so as to receive an effective filing date of 04/21/2021.
Response to Arguments
Applicant’s arguments, see Remarks page 6 (Claims Objections), filed 06/23/2026, with respect to the objections to claims 1, 15, and 23 have been fully considered and are found persuasive. Therefore, the objections to claims 1, 15, and 23 are withdrawn.
Applicant’s arguments, see Remarks page 6 (Claims Rejections Pursuant to 35 U.S.C. § 101), filed 06/23/2026, with respect to the rejections of claims 15-23 under 35 U.S.C. § 101 have been fully considered and are found persuasive. Therefore, the rejections of claims 15-23 are withdrawn.
Applicant’s arguments, see Remarks page 7 (112 (a) Rejections), filed 06/23/2026, with respect to the rejection of claim 21 under 35 U.S.C. § 112(a) have been fully considered and are found persuasive. Therefore, the rejection of claim 21 is withdrawn.
Applicant’s arguments, see Remarks pages 7-8 (112(b) Rejections), filed 06/23/2026, with respect to the rejections of claims 2-3, 5-7, and 11-23 under 35 U.S.C. § 112(b) have been fully considered and are found persuasive. Therefore, the rejections of claims 2-3, 5-7, and 11-23 are withdrawn.
Applicant’s arguments, see Remarks pages 8-10 (Claims Rejections Pursuant to 35 U.S.C. § 102), filed 06/23/2026, with respect to the rejections of claims 1-5, 8-10 and 12-22 under 35 U.S.C. § 102 have been fully considered. Regarding independent claim 1, Applicant argues:
Dijkstra, either alone or in combination with any other prior art cited reference, does not teach or suggest at least the limitations of (with underlined italics for emphasis): "a sensor unit for detecting an irradiation area suitable for vitamin D3 stimulation"; and "a control unit, which is designed to identify the irradiation area and to trigger an emission of light radiation comprising wavelengths in a range of between 280 and 315 nm by the at least one light source if the detected irradiation area does not correspond to a predefined irradiation area excluded from irradiation."
Dijkstra discloses a broadly configurable light therapy device for providing therapeutic treatment to a user's body, wherein the device comprises a camera-based detection system, a controllable light source, and a light directing mechanism. The Examiner argues that the disclosed wavelength range of 100 to 1600 nm inherently encompasses the claimed UVB range of 280 to 315 nm and is therefore inherently capable of stimulating vitamin D3 biosynthesis.
However, Dijkstra is primarily directed to generic phototherapy and does not explicitly disclose a device specifically configured for safely (emphasis added) stimulating vitamin D3 biosynthesis. The disclosure lacks a teaching directed to safely controlled UVB irradiation for vitamin D production. For example, Dijkstra does not teach or suggest at least the safety precaution (emphasis added) of a control unit in which the identified irradiation area is used to trigger UVB irradiation for vitamin D3 stimulation purposes, if the detected irradiation area does not correspond to a predefined irradiation area excluded from irradiation" (emphasis added).
Therefore, a teaching of selecting or identifying irradiation areas suitable for safe vitamin D3 stimulation (emphasis added) is absent in Dijkstra. Rather, Dijkstra merely identifies and tracks a treatment area for movement compensation, but does not identify or select an irradiation area based on its safe suitability for stimulating vitamin D3 biosynthesis (emphasis added). Accordingly, Dijkstra teaches away from the present invention, which is specifically directed to controlled UVB irradiation for safely (emphasis added) inducing vitamin D3 production. (06/23/2026 Remarks, pages 9-10)
This argument is persuasive. The 05/03/2024 claims merely discuss a device for “stimulating the biosynthesis of vitamin D3” via ultraviolet irradiation of the skin. Dijkstra provides skin treatments via ultraviolet irradiation ([0132]) within the claimed wavelengths ([0019, [0067]). While Dijkstra does not specifically mention D3 synthesis, the application of ultraviolet radiation to the skin would promote vitamin D3 synthesis inherently/implicitly, at least to an extent. However, Applicant has amended the device in claim 1 to include “a sensor unit for detecting an irradiation area suitable for vitamin D3 stimulation.” This claim now requires a sensor and corresponding control unit function for determining the suitability of an irradiation area for vitamin D3 stimulation. This teaching is not found in Dijkstra (or Zhang or Powell). Therefore, the rejection of claim 1 is withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Moffat (US 2018/0056088 A1).
Regarding dependent claims, Applicant argues:
Accordingly, for at least the above reasons, Applicant believes that currently amended claim 1 is allowable. Claims 4-5, 8-10 and 12-22 should also be allowable by virtue of their dependence from an allowable claim 1.
New claims 24-26 should be allowable by virtue of their dependence from an allowable claim 1. Furthermore, at least new claims 25 and 26 should be allowable by virtue of the patentable subject matter they contain in and of themselves. (06/23/2026 Remarks, page 10)
This argument is persuasive. Claims 4-5, 8-10, and 12-22 depend on claim 1 where the rejection of claim 1 was withdrawn. Therefore, the rejections of claims 4-5, 8-10, and 12-22 are withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Moffat (US 2018/0056088 A1). New claims 24-26 are rejected over Dijkstra in view of Moffat.
Applicant’s arguments, see Remarks page 11 (Claims Rejections Pursuant to 35 U.S.C. § 103), filed 06/23/2026, with respect to the rejections of claims 6-7, 11, and 23 under 35 U.S.C. § 103 have been fully considered. Regarding claims 6-7 and 11, Applicant argues:
Claims 6-7 and 11 are rejected under 35 USC § 103 as being unpatentable over Dijkstra in view of U.S. Patent Application Publication No. US 2008/0103563 to Powell et al. (herein "Powell"). However, Powell is merely relied upon to teach discrete features recited in dependent claims 6-7 and 11 and does not remedy the deficiencies in Dijkstra with respect to claim 1. Accordingly, claims 6-7 and 11 should be allowable and their associated 103 rejections moot by virtue of their dependence from currently amended claim 1.
Moreover, currently amended claim 11 should also be allowable by virtue of the patentable subject matter it contains in and of itself. More specifically, currently amended claim 11 now recites (with underlined italics for emphasis): "The device according to claim 7, wherein the first light source and the second light source and the third light source and the sensor unit are physically coupled so that they can be jointly directed at the irradiation area by the directing unit." None of the prior art references, alone or in combination, teach or suggest that all three light sources (emphasis added) are physically coupled to the sensor so that they can be jointly directed. (06/23/2026 Remarks, page 11)
This argument is overall persuasive. Claims 6-7 and 11 depend on claim 1 where the rejection of claim 1 was withdrawn. Therefore, the rejections of claims 6-7 and 11 are withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Moffat (US 2018/0056088 A1). However, it should be noted that Powell teaches multiple light sources (UV, visible, and infrared light sources) are coupled together in an array ([0042]).
Regarding claim 23, Applicant argues:
Claim 23 is rejected under 35 USC § 103 as being unpatentable over Dijkstra in view of U.S. Patent Application Publication No. US 2019/0083809 to Zhang. (herein "Zhang"). However, Zhang is merely relied upon to teach discrete features recited in dependent claim 23 and does not remedy the deficiencies in Dijkstra with respect to claim 1. Accordingly, claim 23 should be allowable and its associated 103 rejections moot by virtue of its dependence from currently amended claim 1. (06/23/2026 Remarks, page 11)
This argument is persuasive. Claim 23 depends on claim 1 where the rejection of claim 1 was withdrawn. Therefore, the rejection of claim 23 is withdrawn. However, upon further consideration, a new grounds of rejection is made newly in view of Moffat (US 2018/0056088 A1).
Summary: Prior art rejections for claims 1-23 are withdrawn. For claims 1-23, new prior art rejections newly in view of Moffat are added. Newly added claims 24-26 are rejected under 35 U.S.C. § 103.
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:
❶ Claim 1 - “a directing unit for aligning the at least one light source with the irradiation area”: The limitation does not disclose sufficient structure for the “directing unit.” The “directing unit” is described as “a directing unit can be understood to mean, for example, a mechanical arrangement which is suitable for directing the at least one first light source and/or at least the light radiation of the at least one first light source onto an irradiation area. This can be accomplished, for example, in that a directing unit can be moved and/or pivoted on at least one axis. The directing unit is preferably movable and/or pivotable on at least two axes, so that preferably a cone area, starting from the at least one first light source, can be traversed by the directing unit, so that a plurality of irradiation areas can be sensed within this cone area” (Specification, page 5, lines 17-24). With respect to claim 1, the “directing unit” is interpreted as a mechanical structure which moves or pivots the light source to shine on the directed irradiation area.
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 § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C.
103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-5, 8-10, 12-22, and 24-26 are rejected under U.S.C 103 as being unpatentable over Dijkstra (US 2019/0030359 A1) in view of Moffat (US 2018/0056088 A1).
Regarding Claim 1, Dijkstra discloses a device for providing light therapy ([0001]), comprising:
a) at least one first light source for emitting light radiation comprising wavelengths in a range of between 280 and 315 nm ([0019], [0067] - a light source to project light of 100-1600 nm wavelength, which comprises wavelengths in a range of 280-315 nm),
b) a sensor unit for detecting an irradiation area ([0016] – a camera unit scans the body and captures an image of the treatment area to collect data);
c) a directing unit ([0020] – light direction controller) for aligning the at least one light source with the irradiation area ([0027] – used to direct the irradiation source to follow movements of the body treatment area), and
d) a control unit ([0015] – controlling unit), which is designed to identify the irradiation area ([0015] – controlling unit controls the camera unit) and to trigger an emission of light radiation comprising wavelengths in a range of between 280 and 315 nm by the at least one light source ([0015] – controlling unit controls the light projection unit with previously discussed light wavelengths in [0019]) if the detected irradiation area does not correspond to a predefined irradiation area excluded from irradiation ([0108] – calculating the light exposure in excluded areas to avoid stimulating those areas: “Further, the light therapy device adjusts focus of the light projection in case the light rays scattering out of the treatment portion (towards sensitive areas e.g. eyes) and making user uncomfortable, the light therapy device by analyzing the refractive index of the sensitive areas adjusts the focus of the light and attenuates the light rays to go beyond the treatment portion”).
Dijkstra does not disclose (1) a device having the effect of “stimulating the biosynthesis of vitamin D3” and (2) a sensor unit for detecting an irradiation area suitable for vitamin D3 stimulation.
Note it would be understood that the device in Dijkstra is inherently (MPEP 2114) capable of providing UV-based light therapy to the skin within the required ultraviolet wavelengths ([0028], [0033]) in order to produce a biological effect (which would be understood as providing some extent of stimulating effect on the vitamin D3 synthesis pathway). Dijkstra discloses using the device to treat skin disorders via UV light therapy:
According to an advantageous embodiment of the present disclosure, the device could provide various body treatments e.g. Increasing blood flow, cellular repair, tissue repair, muscle repair, bone repair, wound healing, skin disorders (acne, marks, hives, pimples, herpes, redness, inflammation, itching, irritant, infection, cutaneous disorder, rosacea and any other dermatological problem or disorder) improvement, erectile dysfunction, hair treatment, eyebrow treatment, nose allergy temporomandibular joint dysfunction (TMJ), oral mucositis etc. by using Photo-bio-modulation Therapy, Photodynamic Therapy, UV based light therapy or any other suitable light based therapy. [0132]
However, Dijkstra does not explicitly disclose a device specifically geared towards making determinations about the application of therapy to promote vitamin D3 synthesis.
Moffat, in the same field of endeavor of providing phototherapy for skin irradiation (Abstract), teaches vitamin D3 is a regulator of innate and adaptive immunity (via cathelicidin expression) where both cathelicidin and vitamin D3 deficiencies have been associated with dermatological disorders such as atopic dermatitis, psoriasis, and vitiligo ([0040]). Moffat reports that “D3 deficiency in patients with dermatological disorders is expected be a contributing factor in the efficacy of existing UVB phototherapy devices. For example, a study has shown that high dose vitamin D was an effective treatment for psoriasis and vitiligo” ([0040]). Moffat also reports human skin exposed to ultraviolet B light (with wavelengths between 280-315 nm) converts cutaneous 7-dehydrocholesterol (7-DHC) to
pre-vitamin D3, where pre-vitamin D3 is converted into vitamin D3 ([0041]), meaning UV light exposure results in increased vitamin D3.
Moffat teaches a high energy phototherapy apparatus for applying focused uniform UV radiation to stimulate vitamin D3 production with light emitters positioned on columns a set distance away from the patient (Fig. 33, [0074-0075]). Moffat further teaches a sensor or detector can automatically determine the reflectance or absorbance of the patient’s skin or determine a skin type based on visual comparison with images of known skin type to determine the UV dosage needed for a therapy in terms of a Standard Erythema Dose (SED) ([0067-0069]). The total dose is further determined by the properties of the emitted light energy and percentage of the patient’s skin exposed to the UV light in a manner which minimizes side effects from overdosing of light therapy ([0070-0072]). Distance from the light emitter is also a consideration when determining dose ([0060], [0075]). Moffat summarizes the sensor determination of suitability of skin for D3 stimulation with:
The system 3300 can emit high intensity focused UVB radiation to provide therapeutic effects on dermatological disorders or other indications, and/or facilitate vitamin D production in the skin during relatively short phototherapy sessions. For example, the apparatus 3300 can provide a sufficient amount of irradiation during a phototherapy session (e.g., 30 seconds, 1 minute, 2 minutes, 5 minutes, etc.) to stimulate the production of a weekly or monthly dose of vitamin D. In various embodiments, the exposure time of each phototherapy session can be selected based on the on the user's skin type and/or the intensity of the radiation assemblies 3310. [0077]
Under the broadest reasonable interpretation of the claim language, this would be a determination of the suitability of an irradiation area for vitamin D3 stimulation.
33. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Dijkstra’s device by incorporating the use of UV-B exposure to treat skin disorders associated with vitamin D3 deficiencies and a sensor system capable of making a determination of skin characteristics to arrive at a dose to safely stimulate vitamin D3 production in Moffat. This would have been obvious because both Dijkstra and Moffat are tower devices with light emitters which irradiate UV light from a distance and discuss providing light therapy to the skin to treat a number of conditions. Moffat provides a solution/improvement by specifically using UV-B treatments to treat skin conditions related to vitamin D3 deficiencies and a sensor which determines a more accurate and bespoke dosage based on detected skin characteristics of the patient (as well as distance from light emitters and percent of skin irradiated). Therefore, a person of ordinary skill in the art would be motivated to improve the device of Dijkstra, which uses UV light to treat a variety of skin conditions, by incorporating Moffat’s UV-B light treatment for skin conditions related to vitamin D3 deficiencies where a sensor automatically determines the optimal dosing by evaluating skin type, distance from emitters, and percent of skin to be irradiated.
Regarding Claim 2, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses the sensor unit comprises an optical sensor ([0016] – a camera unit scans the body and captures an image of the treatment portion of the user body to collect data).
Regarding Claim 3, the device according to any one of Claims 1 or 2 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the control unit is designed to control an alignment of the first light source by the directing unit based on an identified irradiation area ([0027] – a light direction controller is used to direct irradiation to follow movement of the body treatment area).
Regarding Claim 4, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses comprising a collecting unit for generating a directed beam of rays from the emission of light radiation by the first light source ([0020] – “the light direction controller uses techniques like saccade mirror, direction tuning film, laser sintering, or mirror type galvanometer etc. for controlling a direction of the light emitted from the light source”).
Regarding Claim 5 the device according to Claim 4 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses the collecting unit comprises a lens ([0020] – saccade mirror and laser sintering would include the use of lenses).
Dijkstra does not disclose a collimator with a collecting lens for generating a directed bundle of rays from the emission of light radiation by the first light source. However, note that only one of a lens or collimator is necessary. Moffat also teaches the radiation assembly in Fig. 33 includes a radiation source 3312, reflector 3336, and filter 3338. The reflector collimates light and the filter can be a lens ([0078]). Therefore, the apparatus in Moffat, specifically built for UV treatments of the skin, would include a lens and collimator.
Regarding Claim 8, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the control unit is designed to identify a human face in an irradiation area ([0074] – can identify a face as the treatment area).
Regarding Claim 9, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the control unit is designed to identify a predefined irradiation area ([0074] – identifies a treatment area as a body location by comparing to stored reference data).
Regarding Claim 10, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses comprising a communication unit for exchanging data ([0091] – communication means for displaying data on a remote device and allowing the user to change settings).
Regarding Claim 12, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the directing unit is designed to be pivotable in at least two axes ([0086] - the target is tracked and the light is applied in three dimensions).
Regarding Claim 13, the device according to Claim 3 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra does not explicitly disclose the irradiation area is a skin area with an area of 40 cm2 to 900 cm2. Dijkstra does not explicitly state a particular surface area to be treated but states a full body or combination of different body parts can be treated using the device ([0074]). Assuming for the sake of argument a 1.94 m2 (19400 cm2) total body surface area (p. 518: “2.06 m2 in male and 1.89 m2 in female (overall)” in Verbraecken et al, “Body surface area in normal-weight, overweight, and obese adults. A comparison study”), a treatment area of a body part such as the arm would be estimated at roughly 9% of the total body surface area using the well-known Rule of Nines. This would place the arm at roughly 0-1746 cm2 depending on how much of the arm was treated. Given this range overlaps with the presented 40-900 cm2, it would be reasonable to conclude Dijkstra’s device would be capable of producing a treatment area of 40-900 cm2.
Regarding Claim 14, the device according to Claim 13 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the skin area of the irradiation area is definable by an adjustable collecting unit ([0072] – a variety of body parts with different areas can be scanned via the adjustable collecting unit; [0074], [0077] – a variety of body parts with different areas can be irradiated based on treatment needs).
Regarding Claim 15, Dijkstra discloses a non-transitory computer program product ([0055-0057]) for carrying out a control of a device for providing light therapy ([0001]), in a device according to claim 1 (see rejection of claim 1 over Dijkstra in view of Moffat), wherein:
a) the computer program product is designed to compare an irradiation area detected by a sensor unit with predefined irradiation areas ([0073], [0086] – the body is tracked via the camera to locate a predefined treatment location via detectable characteristics of that location), and
b) the computer program product is designed to trigger an emission of light radiation ([0077]) comprising wavelengths in a range of 280 nm to 315 nm by at least one first light source ([0019], [0067] - a light source to project light of 100-1600 nm wavelength, which comprises wavelengths in a range of 280-315 nm), if the detected irradiation area does not correspond to an irradiation area excluded from irradiation ([0108] – calculating the light exposure in excluded areas to avoid stimulating those areas).
Dijkstra does not explicitly disclose a device having the effect “stimulating the biosynthesis of vitamin D3.” Note it would be understood that the device in Dijkstra is inherently (MPEP 2114) capable of providing UV-based light therapy to the skin within the required ultraviolet wavelengths ([0028], [0033]) in order to produce a biological effect (which would be understood as providing some extent of stimulating effect on the vitamin D3 synthesis pathway).
As stated in claim 1, the proposed combination with Moffat yields the application of UV light at a distance via a tower structure with light emitters to treat skin disorders associated with vitamin D3 deficiency (where UV irradiation of the skin stimulates vitamin D3 production). A sensor system calculates the optimal dosing based on determinations of patient skin tone, percent of the skin to be irradiated, and distance from the light emitters.
Regarding Claim 16, the computer program product for carrying out a control of a device according Claim 15 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein an irradiation area excluded from irradiation is an irradiation area ([0108] – calculating the light exposure in excluded areas to avoid stimulating those areas) selected from the group consisting of: a human face, a skin area provided with one or more pigment nevi, a skin area provided with scab, wound and/or scar tissue, and a skin area already irradiated within a predefined time interval with light radiation comprising wavelengths in a range of 280 nm to 315 nm ([0067], [0089] – eyes, which are on the face, are given as an example of an excluded area).
Regarding Claim 17, the computer program product for carrying out a control of a device according Claim 15 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the computer program product is designed to assign a time interval to a specific irradiation area in which the irradiation area is to be irradiated with light radiation ([0026] – user defined duration; [0071] – a time interval for a specific treatment can automatically be applied based on previously collected and stored data) comprising wavelengths in a range of 280 nm to 315 nm ([0019], [0067] - a light source to project light of 100-1600 nm wavelength, which comprises wavelengths in a range of 280-315 nm).
Regarding Claim 18, the computer program product for carrying out a control of a device according Claim 15 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the computer program product is designed to control a search of a predefined irradiation area by the computer program product controlling the sensor unit ([0086] – the body is tracked via the camera to locate a predefined treatment location via detectable characteristics of that location).
Regarding Claim 19, the computer program product for carrying out a control of a device according Claim 15 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the computer program product is designed to compare each image detected by an optical sensor with an irradiation area excluded from irradiation ([0108] – calculating the light exposure in excluded areas to avoid stimulating those areas).
Regarding Claim 20, the computer program product for carrying out a control of a device according Claim 15 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the computer program product is designed to enter an operating mode by a signal from the sensor unit ([0086] – the body is tracked via the camera to locate a predefined treatment location via detectable characteristics of that location in order to make a therapy determination) to search for a suitable irradiation area that is not excluded from irradiation (Dijkstra searches for a predefined treatment location in [0086] while avoiding sensitive areas of the body ([0108]).
Regarding Claim 21, the computer program product for carrying out a control of a device according Claim 15 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the computer program product is designed to cause an exposure of an irradiation area to light radiation comprising wavelengths in a range of 280 nm to 315 nm ([0019], [0067] - a light source to project light of 100-1600 nm wavelength, which comprises wavelengths in a range of 280-315 nm; [0028] – UV therapy is a possible treatment), as soon as a sensor unit detects an irradiation area not excluded from irradiation in the effective range of the light source ([0108] – calculating the light exposure in excluded areas to avoid stimulating those areas when irradiating the treatment location).
Regarding Claim 22, the computer program product for carrying out a control of a device according Claim 15 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra discloses further designed to monitor or configure the execution of a control of a device ([0093] – a user can control the light therapy device) for stimulating as part of light therapy on a third-party apparatus via a communication unit ([0093] – a mobile device is communicatively coupled to the light therapy device).
Dijkstra does not explicitly disclose a device having the effect “stimulating the biosynthesis of vitamin D3.” Note it would be understood that the device in Dijkstra is inherently (MPEP 2114) capable of providing UV-based light therapy to the skin within the required ultraviolet wavelengths ([0028], [0033]) in order to produce a biological effect (which would be understood as providing some extent of stimulating effect on the vitamin D3 synthesis pathway).
As stated in claim 1, the proposed combination with Moffat yields the application of UV light at a distance via a tower structure with light emitters to treat skin disorders associated with vitamin D3 deficiency (where UV irradiation of the skin stimulates vitamin D3 production). A sensor system calculates the optimal dosing based on determinations of patient skin tone, percent of the skin to be irradiated, and distance from the light emitters.
Regarding Claim 24, the device according to Claim 2 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the sensor is a camera ([0016] – a camera unit scans the body and captures an image of the treatment area to collect data).
Regarding Claim 25, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra further discloses wherein the predefined irradiation area excluded from irradiation comprises at least one of a face, scar tissue, wound tissue, a scab, a tattoo, or a nevi ([0067], [0089] – eyes, which are on the face, are given as an example of an excluded area).
Regarding Claim 26, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra does not disclose wherein the emission of light radiation on the irradiation area comprises an energy level that is less than a predetermined erythema dose of energy for a user.
As stated in claim 1, the proposed combination with Moffat yields a high energy phototherapy apparatus for applying focused uniform UV radiation to stimulate vitamin D3 production with light emitters positioned on columns a set distance away from the patient (Fig. 33, [0074-0075]). The total dose is determined by the choice of emitted light energy and percentage of the patient’s skin and skin type exposed to the UV light in a manner which minimizes side effects from overdosing of light therapy ([0070-0072]). Moffat teaches skin type is used to calculate 1 Minimal Erythema Dose (MED) ([0067]) where a maximum dose is envisioned as 90% of 1 MED over 100% of a patient’s body area ([0070]).
Claims 6-7 and 11 are rejected under U.S.C 103 as being unpatentable over Dijkstra (US 2019/0030359 A1) in view of Moffat (US 2018/0056088 A1) and Powell (US 2008/0103563 A1).
Regarding Claim 6, the device according to Claim 1 is obvious over Dijkstra in view of Moffat, as indicated hereinabove. Dijkstra discloses a light source capable of generating light ranging from 100-1600 nm wavelengths, which would include visible light ([0019]). However, Dijkstra does not disclose a second light source for emitting light radiation comprising wavelengths in the visible range in a range of 380 nm to 720 nm.
Powell, in the same field of endeavor of providing phototherapy ([0019]), teaches an LED array which has multiple light sources with different wavelengths ([0042] – visible light emitted from a light source: “For example, control panel 130 may select which wavelengths are used in a particular treatment, i.e., blue, red, yellow, green, ultraviolet, infrared, and combinations thereof as discussed herein. Furthermore, in some embodiments, the control panel 130 may be programmed to emit a combination of wavelengths simultaneously to treat different skin conditions at the same time”). Specific wavelengths for these light sources are discussed in [0034]-[0036] which would reside within the 380 nm to 720 nm visible light range. Note Dijkstra [0008] cites Powell as prior art where the simultaneous use of light sources of different wavelengths is emphasized.
33. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Dijkstra’s light source by incorporating the LED array with multiple light sources able to simultaneously emit light in Powell. This would have been obvious because both Dijkstra and Powell discuss providing light therapy to the skin and Powell provides a solution/improvement by allowing multiple light sources of different wavelengths to simultaneously irradiate in order to treat different conditions at the same time. Therefore, a person of ordinary skill in the art would be motivated to improve the light source of Dijkstra, which is capable of producing light from ultraviolet to infrared, by incorporating the LED array with multiple light sources able to simultaneously emit light with multiple wavelengths (such as ultraviolet, visible, and infrared) in Powell. MPEP 2144.05 states “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” There is no evidence of an “unexpected result or criticality” on the analysis from the discussed range interpretations.
Regarding Claim 7, the device according to Claim 6 is obvious over Dijkstra in view of Moffat and Powell, as indicated hereinabove. Dijkstra discloses a light source capable of generating light ranging from 100-1600 nm wavelengths, which would include red/infrared light ([0019]). However, Dijkstra does not disclose a third light source for emitting light radiation comprising wavelengths in the near infrared range in a range of 720 nm to 1800 nm.
As stated in claim 1, the proposed combination with Powell yields an LED array which has multiple light sources with different wavelengths ([0042] – red/infrared light emitted from a light source). Specific wavelengths for these light sources are discussed in [0034]-[0036] which would reside within the 720 nm to 1800 nm range. Note Dijkstra [0008] cites Powell as prior art where the simultaneous use of light sources of different wavelengths is emphasized.
Regarding Claim 11, the device according to Claim 7 is obvious over Dijkstra in view of Moffat and Powell, as indicated hereinabove. Dijkstra discloses the light projection unit 110 and camera unit 120 are both placed and connected within rotatable head 250 (Fig. 2, [0059]) and that the treatment area is both scanned by the camera and irradiated by the light source (Fig. 4A., [0079]). However, Dijkstra does not disclose wherein the first light source and the second light source and the third light source and the sensor unit are physically coupled so that they can be jointly directed at the irradiation area by the directing unit.
As stated in claim 1, the proposed combination with Powell yields an LED array which has multiple light sources with different wavelengths which can be positioned to emit simultaneously during treatment ([0042]). Note light sources in array 108 are coupled to the same plane at the front of the device, meaning they face forward along the same axis (Fig. 1, [0108]). The light source in Dijkstra is capable of producing light from ultraviolet to infrared wavelengths, where the array of multiple light sources in Powell can produce ultraviolet, visible, and infrared light in the same direction.
Claim 23 is rejected under U.S.C 103 as being unpatentable over Dijkstra (US 2019/0030359 A1) in view of Moffat (US 2018/0056088 A1) and Zhang (US 2019/0083809 A1).
Regarding Claim 23, Dijkstra discloses a non-transitory computer program product ([0055-0057]) which can be executed on a third-party apparatus ([0093] – a mobile device is communicatively coupled to the light therapy device) and is designed to manage user data for a device ([0093] – user interface to control device) according to claim 1 (see claim 1 rejection over Dijkstra in view of Moffat). However, Dijkstra does not disclose:
wherein the user data comprises data selected from the group consisting of: skin type, age, occupation and lifestyle; and
wherein the computer program product is designed to exchange said user data in encrypted form with a communication unit of the device.
Note the data only needs to be selected from the provided group and is interpreted as only needing one of the group to constitute a selection.
Zhang, in the same field of endeavor of providing phototherapy ([0002]), teaches a patient-specific parameter can be entered prior to the administration of light therapy ([0234] – age, skin tone and color, and physical activity condition explicitly provided). Additionally, communication of data is encrypted ([0216] – “to ensure that communications transferred to and from the componentry, the provider, etc. are secure and substantially free from a risk of ‘hacking,’ data related to the patient and her treatment etc. can be encrypted using use secure communications (encryption, etc.)”).
33. It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to alter Dijkstra’s device by incorporating the inclusion of demographic data entered to affect the selection of light therapy and encryption of that data in Zhang. This would have been obvious because both Dijkstra and Zhang discuss providing light therapy and Zhang provides a solution/improvement by allowing more personalized light therapy based on patient characteristics and more secured sensitive patient data via encryption. Therefore, a person of ordinary skill in the art would be motivated to improve the apparatus of Dijkstra by incorporating the inclusion of demographic data entered to affect the selection of light therapy and encryption of that data in Zhang.
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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/Benjamin A. Schmitt/
Examiner
Art Unit 3796
/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796