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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference for EP 21173008, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Drawings
Figures 2-4 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to because Fig.’s 2-5 would benefit from labels on the axes. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
Applicant refers to claims 1 and 11 on pg. 3 ln. 21-22 and claims 9 and 1-8 on pg. 8 ln. 10-11. Claim 9 is a cancelled claim. Applicant is recommended to amend specification as the claims are amended.
Abbreviated terms including UV, UVA, UVB, NMSC, and LED should be defined at their first occurrences.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: “NMSC-effective, biological irradiance ENMSC to the erythema-effective, biological irradiance Eer is” should be changed to --NMSC- effective, biological irradiance ENMSC, to the erythema-effective, biological irradiance Eer, is-- to improve understanding. Appropriate correction is required.
In claim 1, the abbreviated terms “UV” and “NMSC” should be defined at their first occurrences.
Claims 1-4 are objected to because of the following informalities: “Eλ(λ)” should be changed to -- Eλ(λ)-- to match the specification. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “ENMSC” should be changed to -- ENMSC --. Appropriate correction is required.
Claims 1 and 10 are objected to because of the following informalities: “Epi” should be changed to -- Epi --. Appropriate correction is required.
Claims 1 and 11 are objected to because of the following informalities: “Eer” should be changed to -- Eer --. Appropriate correction is required.
Claims 1, 10, and 11 are objected to because of the following informalities: “W/m2” should be changed to -- W/m2 --. Appropriate correction is required.
In claim 7, the abbreviated term “LED” should be defined at its first occurrence.
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.
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: “radiation source” in claims 1-4 and 10-12.
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. For “radiation source” in claims 1-4 and 10-12, the specification discloses low-pressure UV lamp, high-pressure UV burner, UV LED, a filter disk combined with these UV sources, and any 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 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 1-8 and 10-12 is 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 is indefinite for the following reasons.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite in that it fails to point out what is included or excluded by the claim language. This claim is an omnibus type claim. Claim 1 lacks transitional phrase. The transitional phrases "comprising", "consisting essentially of" and "consisting of" define the scope of a claim with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim (see MPEP 2111.03). Therefore, it is unclear if open or closed claim language is intended. For the purpose of examination, claims have been interpreted as having open claim language (i.e., inclusive or open-ended and does not exclude additional, unrecited elements or method steps).
Claim 1 does not recite any structural elements for the solarium as claimed. While claim does recite “with a radiation source”, it is unclear if the radiation source is part of the solarium. For the purpose of examination, claims have been interpreted to include a radiation source.
It is unclear which element (solarium, radiation source, or combination of both) would be providing the functional limitation of “designed to emit UV light…Eer is 0.9 or less.” It is further noted that in order for the claimed solarium to provide the functional limitation, a radiation source is necessary.
Dependent claims 2-8 and 10-12 are indefinite for the same reasons provided for claim 1 above.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 11 recites the broad recitation does not exceed 1.0 W/m2, and the claim also recites preferably does not exceed 0.3 W/m2 which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For the purposes of examination, “does not exceed 1.0 W/m2, preferably does not exceed 0.3 W/m2” will be interpreted as “does not exceed 1.0 W/m2”.
Regarding claim 11, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(c)(I) “If stated in a single claim, examples and preferences lead to confusion over the intended scope of the claim”. For the purpose of examination, the limitation following the phrase “preferably” has been interpreted as an optional limitation.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Nilsen et al. (British Journal of Dermatology, 2016, hereinafter referred to as “Nilsen”).
Regarding claim 1, Nilsen teaches a solarium for tanning skin with a radiation source, designed to emit UV light at a spectral irradiance Eλ(λ), the biologically effective irradiance for the direct pigmentation Epi being at least 180 W/m2 (it is a fact that there is an irradiance for skin pigmentation from UV that a tanning bed would have to hit in order to effect a tan, and the higher value is highly effective for rapid tanning), characterized in that the spectral irradiance Eλ(λ) is chosen such that the ratio of the NMSC-effective, biological irradiance ENMSC, to the erythema-effective, biological irradiance Eer (“Erythema-weighted UV is given as the unweighted UV irradiance weighted according to the reference action spectrum for UV-induced erythema (sunburn) in white human skin valid for the UV wavelength region 250–400 nm.” And “Tanning devices are now classified into UV types (1–5) according to their erythema-weighted UVB and UVA irradiances, and with an upper limit (0.7 Wm-2). Since 2010, a more restrictive binding limit (0.3 Wm-2) has applied for all devices in Europe, after the European Commission recommended restricting indoor tanning emission to that of natural tropical sun (0.3 Wm-2; UVI = 12)” Pg. 2; and table 1 “An upper limit of 1 Wm-2 was introduced in 2004, where UV was weighted according to the nonmelanoma skin cancer action spectrum. This corresponds to the present limit of 0.7 Wm-2 weighted with the erythema action spectrum.” Knowing the erythema-effective irradiance, the NMSC-effective irradiance can be calculated.).
Nilsen does not explicitly teach that the ratio is 0.9 or less.
Altering the spectral composition and the ratio of UVA to UVB is a known process in designing the tanning beds. Nilsen does discuss optimization of the erythema-weighted UVB and UVA spectra.
The specification discloses the appropriate ranges that apply to the claimed invention on page(s) 4 as 0.9 or less. However, the specification does not disclose that the specifically claimed range(s) of 0.9 or less is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Nilsen teaches that “Erythema-weighted UV is given as the unweighted UV irradiance weighted according to the reference action spectrum for UV-induced erythema (sunburn) in white human skin valid for the UV wavelength region 250–400 nm” and “Tanning devices are now classified into UV types (1–5) according to their erythema-weighted UVB and UVA irradiances, and with an upper limit (0.7 Wm-2). Since 2010, a more restrictive binding limit (0.3 Wm-2) has applied for all devices in Europe, after the European Commission recommended restricting indoor tanning emission to that of natural tropical sun (0.3 Wm-2; UVI = 12)” on page 2 and table 1 shows “An upper limit of 1 Wm-2 was introduced in 2004, where UV was weighted according to the nonmelanoma skin cancer action spectrum. This corresponds to the present limit of 0.7 Wm-2 weighted with the erythema action spectrum”, the prior art therefore provides teaching that altering the wavelengths to minimize cancer causing agents is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Since Applicants fail to disclose that the claimed range(s) of 0.9 or less provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses that various devices are capable of adjustment to different wavelengths to adjust the NMSC agent absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of 0.9 or less by normal optimization procedures known in the skin tanning arts.
Regarding claims 2-4, Nilsen teaches the solarium characterized in that the spectral irradiance Eλ(λ) has a maximum value in the wavelength range from 330 nm to 364 nm or 390 nm (“The technical standards use UVB and UVA wavelength regions of 250–320 and 320–400 nm, respectively, which differ from the regions for unweighted UVB and UVA of 280–315 and 315–400 nm, respectively.” Pg. 2), and has values in the wavelength range from 299 nm to 311 nm and in the wavelength range from 315 nm to 329 nm or wavelength range from 299-329 nm or has values for wavelengths greater than 364 nm, which do not exceed 5% of said maximum value (“Dividing UVB and UVA at 315 nm as opposed to 320 nm matters, as unweighted UV from tanning lamps increases rapidly around 315–320 nm. Therefore, UVB irradiance will be significantly higher using the wider 280–320-nm region compared with 280–315 nm, as done in some studies. Choosing 250 or 280 nm as the starting wavelength does not matter, as very little UV is allowed from tanning devices below 280 nm and little is emitted. Choosing 315 or 320 nm as the starting wavelength for UVA is ignored in this review, as most unweighted UVA irradiance from tanning lamps is emitted at longer wavelengths.” Pg. 2).
The specification discloses the appropriate ranges that apply to the claimed invention on page(s) 6. However, the specification does not disclose that the specifically claimed range(s) is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed so long as the ratio remains in a safe operation. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since Nilsen teaches that the limit is 0.7 Wm-2 as the standard, the prior art therefore provides teaching that the applicable wavelength is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Since Applicants fail to disclose that the claimed ranges provides a criticality to the invention that separates it from the other ranges in the specification, and the prior art discloses similar ranges for the wavelengths absent unexpected results, it would therefore have been obvious for one of ordinary skill to discover the optimum workable ranges of wavelength range from 299 nm to 311 nm and in the wavelength range from 315 nm to 329 nm by normal optimization procedures known in the skin tanning arts.
Regarding claims 5 and 6, Nilsen teaches characterized in that the radiation source has a low-pressure UV lamp or a high-pressure UV burner (“The radiation source can be either fluorescent low-pressure lamps or high pressure lamps, which have quite different UV spectra.” Pg. 2).
Regarding claim 10, Nilsen does not explicitly teach the solarium characterized in that the biologically effective irradiance for the direct pigmentation Epi is at least 200 W/m2.
The specification discloses the appropriate ranges that apply to the claimed invention on page(s) 8 as at least 180 W/m2 preferably at least 200 W/m2. However, the specification does not disclose that the specifically claimed range(s) of 200 W/m2 is for any particular purpose or to solve any stated problem that distinguishes it from the other ranges disclosed. The specification therefore lacks disclosure of the criticality required by the Courts in providing patentability to the claimed range(s).
In addition to a lack of disclosed criticality in the specification, an obviousness rejection based upon optimization must rely on prior art that discloses the optimized parameter is a result-effective variable. See MPEP 2144.05.
Since it is a fact that there is an irradiance for skin pigmentation from UV that a tanning bed would have to hit in order to effect a tan, Epi is a variable that achieves a recognized result, and satisfies the above requirement of a result-effective variable in order to set forth an obviousness rejection based on optimization.
Since Applicants fail to disclose that the claimed range(s) of 200 W/m2 provides a criticality to the invention that separates it from the other ranges in the specification, it would therefore have been obvious for one of ordinary skill to discover the optimum workable range(s) of 200 W/m2 by normal optimization procedures known in the skin tanning arts.
Regarding claim 11, Nilsen teaches characterized in that the erythema-effective, biologically effective irradiance Eer does not exceed 1.0 W/m2, preferably does not exceed 0.3 W/m2 (“An upper limit of 1 Wm-2 was introduced in 2004” pg. 3, table 1 footnote c).
Regarding claim 12, Nilsen teaches characterized in that the solarium is a sunbed or a sun shower (“Indoor tanning devices (sunbed, shower/stand-up cabinet, portable facial tanner or a tanning chair) have lamps emit ting UV radiation, as the sun does, but with a different ratio of UVB to UVA and more intense total UV.” Pg. 2).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsen as applied to claim 1 above, and further in view of Spivak (US 20040075065 A1, published Apr. 22, 2004, hereinafter referred to as “Spivak”).
Regarding claim 7, characterized in that the radiation source has a UV LED.
Spivak’s invention relates to a method and apparatus for projecting ultraviolet light through man-made energy and illumination sources. More particularly, the present method and apparatus provide for skin tanning through the use of a plurality of ultraviolet light emitting diodes (LED's) in combination with a power modulation circuit (¶[0002]). UV LED's also require far less power than UV fluorescent tubes, and emit far less heat than UV fluorescent tubes. Thus, a UV tanning system according to the present invention has superior energy efficiencies, resulting in significant economic savings, and also far less demand upon electrical utility systems. The present invention thereby enables savings of the natural resources required to generate electricity, and indirectly reduces pollution generated in supplying the energy requirements, in contrast to prior art UV fluorescent tube tanning systems (¶[0032]). An important advantage of UV LED's over UV fluorescent lighting tubes is the consistent UV light output inherent in a UV LED device. Unlike the much larger UV fluorescent lighting tube, which suffers a degradation of efficiency and light output over the course of its life, the much smaller UV LED emits a constant and predictable amount of UV LED light over the course of its service life, which is itself significantly longer than that of a UV fluorescent lighting tube. Therefore, the present invention provides for a tanning bed or booth comprising a lighting source with a significantly longer service life. The present invention also thus provides for significant savings in the cost of light source replacement and in the man-hours required to service the equipment to keep the UV light projection system performing at an acceptable and predictable level (¶[0033]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to use UV LED as the radiation source as taught by Spivak in the solarium of Nilsen for numerous advantages such as using less power, generating less heat, saving money, and providing a predictable output.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Nilsen as applied to claim 1 above, and further in view of Müller (US 20200030626 A1, published Jan. 30, 2020, hereinafter referred to as “Müller”).
Regarding claim 8, characterized in that the radiation source has a filter disk.
Müller’s invention, with the common goal of applying radiation to the skin, relates to a radiation device for the radiation of human skin, preferably the face of a user, in particular at least with radiation in the red light range, with a source of radiation and a filtering device for filtering the radiation emitted by the source of radiation (¶[0002]). The filter disk is, in particular, arranged in the radiation device in such a way that the entire radiation of the source of radiation that leaves the radiation device must pass through the filter disk, in particular whereby the radiation is transmitted to the filter disk, absorbed, and/or reflected (¶[0027]). Preferably, the filter disk, in particular the first coating, is designed so that UV radiation, in particular UV-A radiation and UV-B radiation, is transmitted in a wavelength range from 280 to 400 nm and/or radiation in the red light range in a wavelength range between 600 and 700 nm, preferably from 600 to 650 nm, and/or radiation with a wavelength of greater than 700 nm. The transmittance can be greater than or equal to 50% here, preferably between 50 and 10% , and even more preferably between 85 and 98%. The first coating or the filter disk, respectively, is permeable for the aforementioned different wavelength ranges (¶[0029]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time of filing to use a filter disk with the radiation source as taught by Müller in the solarium of Nilsen in order to filter out the UV wavelengths that are undesirable for the application.
Conclusion
The following prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Sola et al. (Journal of Photochemistry and Photobiology, B: Biology, 2016, pg. 450-455) – spectral irradiances based on erythema
Zolzer et al. (International Journal of Environmental Research and Public Health, 2021) – Calculations including ENMSC
Nilsen et al. (Photochemical & Photobiological Sciences, 2011, pg. 1129-1136) – study on 194 solariums with erythema weighted irradiance
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily N Cirulnick whose telephone number is (571)272-9734. The examiner can normally be reached M-Th 8-5:30 and every other F 8-4:30ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Unsu Jung can be reached at (571) 272-8506. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/E.N.C./ Patent Examiner, Art Unit 3792
/UNSU JUNG/ Supervisory Patent Examiner, Art Unit 3792
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