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 .
Summary
The Applicant’s arguments and claim amendments received on July 10, 2026 are entered into the file. Currently, claims 1, 8-10, and 12 are amended; claims 13, 14, and 17 are cancelled; claims 21-24 are withdrawn; resulting in claims 1-12, 15, 16, 18-20, 25, and 26 pending for examination.
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, 3-12, 15, 18-20, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Dayton (US 2017/0157279, previously cited) in view of Kang et al. (US 2007/0054223, previously cited) and Amhof et al. (US 2001/0006818, previously cited).
Regarding claims 1, 11, and 15, Dayton teaches a photochromic indicator (10; laminate) comprising a protective layer (14) having a photochromic material (12; photochromic pigment) applied to the inward-facing surface (20) of the protective layer, wherein the photochromic material is disposed between the inward-facing surface of the protective layer and a pressure-sensitive adhesive (18) ([0021], see Fig. 2A reproduced below). The protective layer (14) corresponds to the claimed first layer which is a continuous layer having a photochromic material (12) deposited on a first surface thereof.
Dayton further teaches an alternative embodiment in which the photochromic material (12) is formed between the protective layer (14) and an underlying backing layer (26) ([0024], see Fig. 2B reproduced below). In this embodiment, either the protective layer (14) or the backing layer (26) can be taken to correspond to the claimed first layer which is a continuous layer having a photochromic material (12) deposited on a first surface thereof.
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Dayton teaches that the pressure-sensitive adhesive (18) is used to adhere the indicator to a surface (22), such that the indicator can be applied as a sticker, decal, label, or placard to the surface to be rendered pathogen-reduced during a decontamination process and can be disposable to be replaced after a predetermined period of time ([0021]-[0022], [0050], claim 8, Fig. 3). Therefore, the pressure-sensitive adhesive corresponds to the claimed second layer which is a coupling layer configured to removably couple the photochromic indicator to a component.
Dayton teaches that the photochromic material may be substantially transparent to visible light prior to exposure to UVC light such that the indicator is minimally detectable at a casual glance (first state, invisible to the naked eye under ambient lighting), and may be selected to change color, exhibit a variable opacity, etc. (second state, visible to the naked eye under ambient lighting) once exposed to UVC light ([0024], [0045]).
Dayton further teaches that each of the regions (12A, 12B, 12C) of photochromic material can exhibit different visible responses to being exposed to UV light, which can be achieved by forming each of the plurality of regions from a different photochromic material ([0046]-[0047]). Dayton therefore teaches that the photochromic material comprises a first pigment and a second pigment. Alternatively, each of the regions (12A, 12B, 12C) can exhibit the same visible response to being exposed to UV light ([0045]), such that a first particle of the photochromic material and a second particle of the photochromic material can be taken to correspond to the claimed first and second pigments.
Dayton further teaches that the apparatus can utilize a reversible photochromic indicator that exhibits a visible response to receiving a predetermined minimum exposure to UVC light emitted, wherein an extent to which a decontamination process was completed can be determined based on whether the photochromic material exhibits the visible response ([0007]-[0009]). The second state therefore serves to indicate that the indicator has been exposed to the UV light source for disinfection. Dayton further teaches that the photochromic material may exhibit the visible response to a lesser extent after the photochromic material ceases to be exposed to the UVC light (e.g., returns to its original appearance) ([0008], [0044]), such that the photochromic material is capable of changing from the visible second state back to the invisible first state after a predetermined period of time. In particular, Dayton teaches that the photochromic indicator can be left in place for use during multiple decontamination processes, or can be disposable to be replaced after a predetermined period of time or a predetermined number of decontamination processes have been performed ([0050]), such that the indicator can be used to indicate disinfection of a surface of a component for a plurality of disinfection cycles without the laminate being replaced. Dayton further teaches a variety of photochromic materials, such as materials based on spiropyrans, spirooxazines, and diarylethenes ([0027])-[0043]), which are known to be reversible photochromic pigments capable of undergoing a plurality of color-changing cycles between invisible and visible states.
Although Dayton teaches that the photochromic material (12) may be formed as distinct regions (12A, 12B, 12C) for the purposes of redundancy so that if one region is damaged, the other regions can still be relied upon to provide a visible response ([0045]), Dayton differs from the claimed invention in that the reference does not expressly teach that the first layer includes a pigment texture comprising an embossed pattern, wherein the photochromic pigment is disposed in the embossed pattern.
However, in the analogous art of photochromic articles, Kang et al. teaches a photochromic film comprising an embossed portion (32) formed on a part or whole of a basic material (31) which is coated with a photochromic substance (33) that fills each of the unit embossed portions (Abstract, [0024], Fig. 3). Similar to Dayton, Kang et al. teaches that by filling embossed portions with the photochromic substance, each of the unit embossed portions are isolated from each other, thereby prolonging the life of the photochromic substance ([0002], [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photochromic indicator taught by Dayton by forming a pigment texture comprising an embossed pattern in the first layer with the photochromic pigment disposed therein, as taught by Kang et al., in order to isolate the embossed portions from each other so as to prolong the life of the photochromic material.
With respect to the limitation requiring that the laminate is configured as a roll, although Dayton teaches that the photochromic indicator (10) may be applied to surfaces (22) of objects (24) such as a patient bed, tray table, and door, e.g., in a patient room or examination room within a healthcare facility ([0004], [0026], Fig. 3), the reference does not expressly teach that the indicator is configured as a roll including a plurality of perforations defining a plurality of pre-formed laminates.
However, in the analogous art of sterilization indicators, Amhof et al. teaches a label which may be used in a sterilization tracking system, wherein the label has first and second portions which each change color upon exposure to a sterilization procedure (Abstract, [0018]). The label (10) comprises first and second portions (26, 28; sections, pre-formed laminates) constructed to be manually separable from each other, for example, by perforations (35) which allow manual tearing of the second portion from the first portion ([0034], Figs. 1-2). Amhof et al. teaches a sterilizing tracking system which involves adhering the label to an object to be sterilized, subjecting the object to a sterilization procedure, removing the second portion of the label from the first portion, leaving the first portion adhered to the object, and then adhering the second portion to a patient’s file such that the label provides a link between a patient and records kept on sterilization parameters, e.g., at a hospital ([0074]-[0079], [0082], Figs. 4a-4f). Amhof et al. further teaches that the labels may be wound on a core with approximately 2500 feet per roll [0071].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photochromic indicator taught by Dayton in view of Kang et al. by forming the indicator to have a plurality of sections which are separated from each other by perforations, such that the plurality of perforations define a plurality of pre-formed laminates, as taught by Amhof et al., in order to enable one section of the indicator to remain attached to the sterilized object while another section can be easily detached and retained for record-keeping purposes. Moreover, it would have been obvious to one of ordinary skill in the art to provide the photochromic indicators as a roll wound around a core, as taught by Amhof et al., in order to provide a large quantity of indicators in a more compact form.
Regarding claims 3 and 4, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above, and Dayton further teaches that the protective layer (14) is formed of a material that is substantially transparent to UVC light (e.g., allows transmission of at least 60% of the intensity of UVC light) [0019]. Dayton teaches that short-wave ultraviolet (UVC) includes wavelengths within a range from about 250 nm to about 260 nm [0006]. Therefore, the protective layer of the first layer is formed of a material that is at least 30% UV transparent to light within a wavelength range from about 250 nm to about 260 nm, which falls squarely within the range of claim 4.
Regarding claim 5, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 3 above. As noted above, Dayton teaches that the protective layer (14) is formed of a material that is substantially transparent to UVC light, which includes wavelengths within a range from about 250 nm to about 260 nm ([0006], [0019]). Therefore, the protective layer of the first layer is formed of a material that is at least 30% UV transparent to light within a wavelength range from about 250 nm to about 260 nm, which overlaps the range of claim 5. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Regarding claim 6, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above, and Dayton further teaches that the protective layer (14) can be formed from UVC transmissive materials such as fluorinated ethylene propylene ([0019]), which is a non-flammable material.
Regarding claims 7, 8, and 12, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above. As shown in Fig. 1 of Dayton, the photochromic indicator (10) is illustrated as having a generally rectangular shape with a plurality of edges defining a surface area thereof. The photochromatic indicator includes a plurality of regions of photochromic material (12A, 12B, 12C; plurality of indicators) formed across less than an entirety of the surface area as an ordered array ([0019], Fig. 1).
Regarding claim 9, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 7 above. Dayton teaches an embodiment in which at least one, and optionally a plurality of regions of photochromic material (12A,12B, 12C; plurality of indicators) are formed as distinct regions across less than the entirety of the surface area ([0019], Fig. 1C), and differs from the claimed invention in that the reference does not expressly teach an embodiment in which the plurality of indicators are formed across an entirety of the surface area.
It would, however, have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photochromatic indicator taught by Dayton in view of Kang et al. and Amhof et al. by forming the regions of photochromic material across the entirety of the surface area in order to increase the area covered by the photochromatic material to thereby enable a user to more easily observe a color change.
Regarding claim 10, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above, and Dayton further teaches that the photochromatic layer (10) includes a plurality of regions of photochromatic material (12A, 12B, 12C; plurality of indicators) which each optionally exhibit different visible responses (e.g., turn different colors) [0046]. Therefore, the plurality of regions of photochromatic material include a first color and a second color which is different from the first color.
Regarding claim 18, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above. As noted above, Dayton teaches that the photochromic material (12) can be formed as a plurality of regions (12A, 12B, 12C) of photochromic material which exhibit different visible responses by each region using a different photochromic material ([0046]-[0047]). Dayton teaches that the photochromic material can be selected to continually exhibit a visible response to UVC exposure for a predetermined length of time (e.g., at least 2 minutes, at least 15 minutes, etc.) after the material ceases to be exposed to UVC light, where the visible response exhibited by the photochromic material is reversible ([0007], [0044]). Dayton further teaches that the different visible responses may be used to estimate the progress of the decontamination process [0046].
The different photochromic materials used in the different regions therefore correspond to the claimed first and second pigments which are configured to change from the second to the first state after first and second different predetermined periods of time. One of ordinary skill in the art would recognize that different photochromic materials would have at least somewhat different reversion times, such that the first pigment can be taken to correspond to the material having a reversion time that is less than the reversion time of the second pigment.
Regarding claim 19, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above. In the case where the protective layer (14) in the indicator taught by Dayton corresponds to the claimed first layer, the first layer is an outermost layer of the indicator (Fig. 2A).
Regarding claim 20, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above. In the case where the backing layer (26) in the indicator taught by Dayton corresponds to the claimed first layer, the protective layer (14) which is formed on top of the backing layer having the photochromic material (12) is an outermost layer of the laminate (Fig. 2B).
Regarding claim 25, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above, and Dayton further teaches that the protective layer is formed of UVC transmissive materials, wherein the listed polymeric materials are only UVC transmissive when formed at small cross sectional thicknesses, such as 0.001 to 0.005 in ([0019]), equivalent to 1 to 5 mils, which falls squarely within the claimed range. In the case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists. See MPEP 2144.05(I).
Claims 2 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dayton (US 2017/0157279, previously cited) in view of Kang et al. (US 2007/0054223, previously cited) and Amhof et al. (US 2001/0006818, previously cited) as applied to claim 1 above, and further in view of Young et al. (US 2020/0047868, previously cited).
Regarding claim 2, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above. Although Dayton further teaches that the protective layer can be formed from any UVC transmissive materials applied over the photochromic material, wherein examples of polymeric materials are listed ([0019]), the reference does not expressly teach that the first layer is formed from a fiberglass material or a polyvinyl material.
However, in the analogous art of adhesive laminates, Young et al. teaches a decorative laminate (10) comprising a first layer (62a), a decorative layer (76), and a second layer (62b), wherein the decorative layer is selectively disposed between the first and second layers ([0026], Fig. 1). Similar to the photochromic indicator of Dayton, the decorative laminate taught by Young et al. may include light-activated materials in the decorative layer, for instance, an ultraviolet (UV) activated pigment that is non-visible until exposed to a source of UV light, wherein the decorative layer can be deposited in a decorative and/or functional pattern [0027]. Young et al. teaches that the first layer (62a) can be transparent to ultraviolet and/or infrared light in order to allow such light incident on the first layer to penetrate to the decorative layer and affect any light-activated materials, wherein polyvinyl fluoride materials are said to be advantageous for the laminate layers due to their physical toughness, chemical inertness, abrasion resistance, consistent performance regardless of temperature changes, and print receptivity ([0029], [0048]). The laminate layers can additionally or alternatively include non-polymer materials; for instance, a thermoplastic fluoropolymer material can be reinforced with glass fibers (fiberglass), wherein such reinforced materials can be advantageous for use in high-traffic areas [0049].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photochromic indicator of Dayton in view of Kang et al. and Amhof et al. by selecting a fiberglass-reinforced polyvinyl material as the material of the protective layer onto which the photochromic material is printed, as taught by Young et al., in order to ensure that the indicator has good physical toughness, chemical inertness, abrasion resistance, and print receptivity and to enable the indicator to be used in high-traffic areas.
Regarding claim 16, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 1 above but does not expressly teach that a backing layer is removably coupled to the adhesive layer.
However, in the analogous art of adhesive laminates, Young et al. teaches a decorative laminate comprising an adhesive layer, such as a pressure-sensitive adhesive, and a release liner (backing layer) which can be removed from the adhesive and discarded when the decorative laminate is applied to a substrate ([0058]-[0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the photochromic indicator of Dayton in view of Kang et al. and Amhof et al. by including a release liner removably coupled to the second adhesive layer, as taught by Young et al., in order to protect the adhesive prior to application of the indicator to a substrate or surface.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Dayton (US 2017/0157279, previously cited) in view of Kang et al. (US 2007/0054223, previously cited) and Amhof et al. (US 2001/0006818, previously cited) as applied to claim 15 above, and further in view of Drexler et al. (US 20160089851, cited on IDS).
Regarding claim 26, Dayton in view of Kang et al. and Amhof et al. teaches all of the limitations of claim 15 above. Although Dayton teaches that the indicator (10) can include a pressure-sensitive adhesive (18) used to adhere the indicator to a variety of surfaces, such as a bed, a tray table, or a door ([0021], [0026], claim 8, Fig. 3), the reference does not teach that the adhesive comprises a heat-activated adhesive.
However, in the analogous art of adhesive laminates, Drexler et al. teaches a decorative laminate used in a variety of applications, including for surfaces of walls, countertops, and aircraft interior structural components such as ceiling panels, floor panels, stowage bins, lavatory and galley panels, and the like [0004]. Drexler et al. teaches that an adhesive layer (63) is formed on a side of the decorative laminate (10) so that the laminate can be attached to a structural component (28) ([0050], [0051], Figs. 4A-4B). The adhesive layer may comprise a pressure-sensitive adhesive, a hot melt adhesive, a spray adhesive, or another suitable adhesive [0050].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the indicator taught by Dayton in view of Kang et al. and Amhof et al. by substituting the pressure sensitive adhesive for a hot melt adhesive, as taught by Drexler et al., as both are known to be suitable for adhering laminates to surfaces of objects. One of ordinary skill in the art would recognize that the type of adhesive (e.g., pressure sensitive or hot melt) may be appropriately selected based the type of surface to which the laminate is intended to be adhered.
Response to Arguments
Response-Claim Rejections - 35 USC § 112
The previous rejections of claims 1-12, 15, 16, 18-20, 25, and 26 under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention is overcome by the Applicant’s amendments to claims 1, 8-10, and 12 in the response filed July 10, 2026.
Response-Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 8-10 of the remarks filed July 10, 2026, have been considered but are moot because they do not address the new combination of references being used in the rejections above. In light of the amendments to claim 1, Amhof et al. is applied in combination with Dayton and Kang et al. to address the new limitations directed to the laminate being configured as a roll including a plurality of perforations defining a plurality of pre-formed laminates.
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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