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 .
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.
Claim(s) 1-3, 5-14, and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baldy et al. US 2010/0232003.
Regarding claim 1, Baldy discloses an ophthalmic article (see para 0027), comprising: a polymer substrate (para 0032-0035: teaches ophthalmic lens formed from polymeric substrates, including CR-39, polycarbonate, polyurethane, and other polymeric material suitable for ophthalmic lens);
wherein the polymer substrate comprises at least one area with a blend of contrast-enhancing dyes and photochromic dyes (para 0015, 0025-0029: discloses an optical article comprising photochromic material and fixed-tint colorants (dyes and/or pigments), para 0065-0066: further discloses fixed-tint colorants and photochromic material incorporated into the polymer substrate), para 0025-0028-0029: further discloses the fixed-tint colorants selected to enhance contrast between an object of interest and its surrounding environment).
Badly does not specifically disclose: wherein the ophthalmic article presents, at least in the at least one area with the blend of contrast-enhancing dyes and photochromic dyes, a contrast level value of Kup≥20 in an activated state of the photochromic dyes, which is higher than the contrast level value in a deactivated state of the photochromic dyes.
However, Baldy disclose an ophthalmic article exhibiting a passive (deactivated) state and an activated state in response to actinic radiation, wherein the spectral transmission differs between the passive and activated states (see para 0015, 0028). Baldy further teach that selective spectral attenuating in the activated state enhances contrast and object detectability relative to the surrounding environment (see para 0028-0029). Applicant defines Kup as metric based on an increase in chroma (C*ab) relative to vision without the lens, which reflects the degree of contrast enhancement achieved rather than an additional structural feature of the ophthalmic article. Although, Baldy et al. do not expressly recite the term “Kup” or the numerical threshold “Kup≥20”, achieving a particular degree of contrast enhancement represents optimization of a result-effective variable once contrast enhancement is taught as the design objective. It therefore would have been obvious to one of ordinary skill in the art before the effective filing date to select dye systems and concentration in Baldy so as to achieve a desired level of contrast enhancement, including Kup value of at least 20, as a matter of routine optimization. Additionally, Baldy explicitly teach combining photochromic material with fixed-tint dyes in polymer ophthalmic substrate to enhance contrast between objects and their surrounding environments, with different optical performance in activated versus deactivated states (see para 0028). Baldy further demonstrate spectral transmission profiles selected to enhance contrast, providing a reasonable expectation that routine adjustment of dye selection and concentration would achieve the claimed level of contrast enhancement. Once the goal of increasing contrast via spectral shaping is disclosed, selecting or achieving a particular quantitative contrast threshold (Kup≥20) would have been predictable and obvious design choice, consistent with KSR int’l Co. v. Teleflex Inc. and In re Aller, which hold that optimizing known result-effective variable does not confer patentability.
Regarding claim 2, Baldy discloses the ophthalmic article of claim 1, but fails to explicitly disclose wherein the ophthalmic article presents a value of luminous transmittance Tv according to ISO standard 12312 of less than 65% in the deactivated state of the photochromic dyes. However, Baldy disclose ophthalmic articles including fixed-tint colorant in combination with photochromic materials, such that the lenses exhibit reduced luminous transmittance even in the deactivated (passive) state (see para 0015, 0025-0029). Baldy further contemplate lenses intended for sunglass and outdoor use, which inherently require luminous transmittance values significantly below those of clear lenses. Luminous transmittance (Tv) is known result-effective variable in the design of ophthalmic and sunglass lenses, and ISO 12312 merely specifies a standard method for measuring Tv. It would have been obvious to one of ordinary skill in the art before the effective filing date to select the type and concentration of fixed-tint colorants in Baldy such that the ophthalmic article exhibits a luminous transmittance of less than 65% in the deactivated state, as a routine and predictable design choice for achieving desired light attenuation.
Regarding claim 3, Baldy discloses the ophthalmic article of claim 1, but fails to disclose wherein a value of luminous transmittance Tv according to ISO standard 13666 is greater than or equal to 9% and less than or equal to 18% in the activated state of the photochromic dyes. However, Baldy disclose photochromic ophthalmic articles that, upon activation exhibit substantially reduced luminous transmittance suitable for bright outdoor and sunglass application (see para 0015, 0028-0029). Baldy further illustrate activated-state spectral transmission profiles consistent with strong attenuation across the visible spectrum. Luminous transmittance (Tv) in the activated state is a known, result-effective variable in the design of photochromic ophthalmic lenses and is routinely controlled by selection of photochromic dye type, concentration, and lens construction. ISO standard 13600 merely specifies a standard method for defining and measuring Tv an does not impose an additional structural limitation. It would have been obvious to one of ordinary skill in the art before the effective filing date to select and adjust the photochromic system of Baldy such that the activated-state luminous transmittance falls within a desired range, including Tv of greater than or equal to 9% and less than or equal to 18%, as a predictable and routine design choice.
Regarding claim 5, Baldy discloses the ophthalmic article of claim 1, wherein the contrast-enhancing dyes present one transmission minimum at wavelengths greater than or equal to 470 nanometers (nm) and less than or equal to 500 nm (see Fig. 1: transmission of the article at wavelength 470 nm is greater than transmission at 500 nm).
Regarding claim 6, Baldy discloses the ophthalmic article of claim 1, wherein the contrast-enhancing dyes present one transmission minimum at wavelengths greater than or equal to 570 nanometers (nm) and less than or equal to 600 nm (see Fig. 1).
Regarding claim 7, Baldy discloses the ophthalmic article of claim 1, wherein a transmission spectrum presents a minimum at wavelengths greater than or equal to 580 nanometers (nm) and less than or equal to 590 nm, in the activated state of the photochromic dyes, that is less than 6% (see Fig. 1).
Regarding claim 8, Baldy discloses the ophthalmic article of claim 1, wherein a transmission spectrum presents a minimum at wavelengths greater than or equal to 425 nanometers (nm) and less than or equal to 435 nm, with a transmission less than 2% in the activated of the photochromic dyes and in the deactivated state of the photochromic dyes (see Fig. 3).
Regarding claim 9, Baldy discloses the ophthalmic article of claim 1, wherein the ophthalmic article has a transmission at 400 nanometers (nm) that is less than or equal to 7.5% (see Fig. 1).
Regarding claim 10, Baldy discloses the ophthalmic article of claim 1, wherein the contrast-enhancing dyes and the photochromic dyes are blended in a bulk of the polymer in the polymer substrate (para 0065-0066: “If the substrate is formed from a polymeric material, the fixed-tint colorant and/or photochromic material may be connected to at least a portion of the substrate …”).
Regarding claim 11, Baldy discloses the ophthalmic article of claim 1, where the ophthalmic article exhibits a difference of at least two categories according to ISO standard 12312 between the deactivated state of the photochromic dyes and the activated state of the photochromic dyes (see para 0015, 0028-0029, and Figs. 1-3: discloses ophthalmic articles exhibiting a passive (deactivated) state and an activated photochromic state having substantially different spectral transmission characteristics).
Regarding claims 12, 14 and 19, Baldy discloses the ophthalmic article of claim 1, except for where the ophthalmic article exhibits a difference of at least 35% of a value of luminous transmittance Tv according to ISO standard 12312 between the deactivated state of the photochromic dyes and the activated state of the photochromic dyes, wherein a value of luminous transmittance Tv according to ISO standard 13666 is greater than or equal to 11% and less than or equal to 16% in the activated state of the photochromic dyes, and where the ophthalmic article exhibits a difference of at least 50% of a value of luminous transmittance Tv according to ISO standard 12312 between the deactivated state of the photochromic dyes and the activated state of the photochromic dyes. However, Baldy discloses ophthalmic articles having a passive (deactivated) state and an activated photochromic state with substantially different spectral transmission characteristics, wherein the activated state exhibits significantly reduced luminous transmittance relative to the deactivated state (see para 0015, 0028-0029). Baldy further illustrate large differences in optical transmission between the two states, consistent with lenses intended for outdoor and sunglass use. Therefore, luminous transmittance (Tv) is a known result-effective variable in photochromic lens design, and ISO standard 12312 merely specifies a method for measuring Tv. Achieving a difference in luminous transmittance of at least greater than or equal to 11% and less than or equal to 16%, 35% and 50% between the deactivated and activated states represent selection of a degree of photochromic darkening, which is routine and predictable design choice. Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to select photochromic materials and dye concentration in Baldy so as to achieve a Tv difference of at least greater than or equal to 11% and less than or equal to 16%, 35% and 50% between the deactivated and activated states.
Regarding claim 13, Baldy discloses sunglasses comprising the ophthalmic article of claim 1 (see para 0005-0006).
Regarding claim 16, Baldy discloses the ophthalmic article of claim 1, wherein the contrast-enhancing dyes present one transmission minimum at wavelengths greater than or equal to 485 nanometers (nm) and less than or equal to 495 nm (see Fig. 3).
Regarding claim 17, Baldy discloses the ophthalmic article of claim 1, wherein the contrast-enhancing dyes present one transmission minimum at wavelengths greater than or equal to 580 nanometers (nm) and less than or equal to 590 nm (see Fig. 2).
Regarding claim 18, Baldy discloses the ophthalmic article of claim 1, wherein the ophthalmic article has a transmission at 400 nanometers (nm) that is less than or equal to 5% (see Fig. 2).
Regarding claim 20, Baldy discloses an ophthalmic article (see para 0027), comprising: a polymer substrate (para 0032-0035: teaches ophthalmic lens formed from polymeric substrates, including CR-39, polycarbonate, polyurethane, and other polymeric material suitable for ophthalmic lens);
wherein the polymer substrate comprises at least one area with a blend of contrast-enhancing dyes and photochromic dyes (para 0015, 0025-0029: discloses an optical article comprising photochromic material and fixed-tint colorants (dyes and/or pigments), para 0065-0066: further discloses fixed-tint colorants and photochromic material incorporated into the polymer substrate), para 0025-0028-0029: further discloses the fixed-tint colorants selected to enhance contrast between an object of interest and its surrounding environment).
Badly does not specifically disclose: wherein the ophthalmic article presents, at least in the at least one area with the blend of contrast-enhancing dyes and photochromic dyes, a contrast level value of Kup≥30 in an activated state of the photochromic dyes, which is higher than the contrast level value in a deactivated state of the photochromic dyes.
However, Baldy disclose an ophthalmic article exhibiting a passive (deactivated) state and an activated state in response to actinic radiation, wherein the spectral transmission differs between the passive and activated states (see para 0015, 0028). Baldy further teach that selective spectral attenuating in the activated state enhances contrast and object detectability relative to the surrounding environment (see para 0028-0029). Applicant defines Kup as metric based on an increase in chroma (C*ab) relative to vision without the lens, which reflects the degree of contrast enhancement achieved rather than an additional structural feature of the ophthalmic article. Although, Baldy et al. do not expressly recite the term “Kup” or the numerical threshold “Kup≥30”, achieving a particular degree of contrast enhancement represents optimization of a result-effective variable once contrast enhancement is taught as the design objective. It therefore would have been obvious to one of ordinary skill in the art before the effective filing date to select dye systems and concentration in Baldy so as to achieve a desired level of contrast enhancement, including Kup value of at least 30, as a matter of routine optimization. Additionally, Baldy explicitly teach combining photochromic material with fixed-tint dyes in polymer ophthalmic substrate to enhance contrast between objects and their surrounding environments, with different optical performance in activated versus deactivated states (see para 0028). Baldy further demonstrate spectral transmission profiles selected to enhance contrast, providing a reasonable expectation that routine adjustment of dye selection and concentration would achieve the claimed level of contrast enhancement. Once the goal of increasing contrast via spectral shaping is disclosed, selecting or achieving a particular quantitative contrast threshold (Kup≥30) would have been predictable and obvious design choice, consistent with KSR int’l Co. v. Teleflex Inc. and In re Aller, which hold that optimizing known result-effective variable does not confer patentability.
Claim(s) 4 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baldy as applied to claim 1 above, and further in view of Larson et al. US 2017/0299895.
Regarding claims 4 and 15, Baldy teaches the ophthalmic article of claim 1, except for wherein the contrast-enhancing dyes are narrow-band dyes with a full width at half maximum (FWHM) greater than or equal to 5 nanometers (nm) and less than or equal to 50 nm, and wherein the contrast-enhancing dyes are narrow-band dyes with a full width at half maximum (FWHM) greater than or equal to 10 nanometers (nm) and less than or equal to 30 nm. However, Boldy disclose ophthalmic articles in which contrast enhancement is achieved through selective spectral attenuation of specific wavelength regions, rather than uniform broadband absorption (para 0025, 0028-0029). Baldy therefore teach the use of spectrally selective contrast-enhancing dyes having defined absorption bands to improve visual contrast.
Larson expressly disclose ophthalmic spectacle lenses employing wavelength-selective contrast enhancing dyes, wherein the absorption bands are characterized by their full width at half maximum (FWHM). In particular, Larson explicitly disclose narrow-band absorption features having FWHM values within the claimed range, including FWHM value of approximately 18 nm, 18 nm, and 22 nm as shown in Figs. 1D1, 1E2, and 1F1 and para. 0117 and 0119. These explicitly disclosed FWHM values fall squarely within claimed range of greater than or equal to 5 nm and less than or equal to 50 nm. The full width at half maximum (FWHM) of an absorption band is a result-effective variable that directly controls spectral selectivity and contrast enhancement in ophthalmic lenses. In view of Baldy teaching of selective spectral filtering for contrast enhancement and Larson explicit teaching of narrow-band contrast-enhancing dyes having FWHM values within the claimed range, it would have been obvious to a person of ordinary skill in the art to select contrast-enhancing dyes having a FWHM of 5-50 nm as a routine and predictable design choice when implementing the contrast-enhancing ophthalmic article taught by Baldy.
Conclusion
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/EPHREM Z MEBRAHTU/Primary Examiner, Art Unit 2872