5DETAILED 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 .
Response to Amendment
The amendment filed 04/08/2026 has been entered. Amendments to claims 1, 11, 19, and 23, cancellation of claim 22, and new claim 24 are acknowledged. Claims 1,2, 6-11, 14-20, and 23-24 remain pending in the application. Applicant’s amendments to the Claims have overcome each and every objection and 112(b) rejection previously set forth in the Final Office Action mailed 03/17/2026.
Claim(s) 1-2, 7-11, 14-17, 19-20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ranchod et al. (US20080146913A1, as cited by applicant’s IDS filed 08/22/2023) in view of Johnson (US 5394824 A).
Regarding claim 1, Ranchod discloses a device for locating a venous structure of a subject ([0009]: " an improved vein-visualization or vein-locating device that is intended for use during intravenous access medical procedures"), the device comprising: a substrate layer ([0016]: " a frame having a bottom surface and a top surface"); and a plurality of sections of thermochromic elements positioned on the substrate layer ([0016]: "one or more sections removably attached to the top surface of the frame. The sections are formed of a liquid crystal material that is sensitive to human skin temperature ranges."), wherein each section of the thermochromic elements is separated from another section of the thermochromic elements ([0032]: “preferably strips, of encapsulated enantiotropic cholesteric liquid crystalline phase material exhibiting a mesophase color change at temperature(s) corresponding to human skin temperatures. The device 110 allows clinicians to both visualize the target vasculature and gain access to that vasculature.” Fig 4b, wherein the sheets are separated), and wherein the plurality of sections of thermochromic elements comprises a first section of thermochromic elements (Fig 4b top section 130).
Ranchod fails to disclose a first section of thermochromic elements that includes a first thermochromic unit arranged on the substrate layer and including first molecules; and a second thermochromic unit overlaid atop the first thermochromic unit and including second molecules, wherein, when the first and second thermochromic units are exposed to heat, the first and second molecules rotate and align at an angle, thereby exhibiting a color corresponding to the angle.
Johnson discloses a first thermochromic unit arranged on the substrate layer (Fig 3D, col 8 lines 41-44: “thermochromic sensor layer 94,”) including first molecules (col 5 lines 21-42 and 49-50: “thermochromic sensor 32 is formed from liquid crystal thermochromic material… molecules of the liquid crystals”), and a second thermochromic unit overlaid atop the first thermochromic unit (Fig 3D, col 8 lines 41-44: thermochromic sensor layer 92) and including second molecules (col 5 lines 21-42 and 49-50: “thermochromic sensor 32 is formed from liquid crystal thermochromic material… molecules of the liquid crystals”), wherein, when the first and second thermochromic units are exposed to heat, the first and second molecules rotate and align at an angle, thereby exhibiting a color corresponding to the angle (col 3 lines 39-45: “The molecules of the liquid crystals are arranged in spiral stacks, and the color is determined by the pitch of this spiral--the length in which it makes one complete turn. As the temperature rises, the spiral twists and the pitch gets shorter. The crystal reflects only light with a wavelength the same as the pitch of the spiral.”.)
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the thermochromic elements disclosed by Ranchod to the plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer disclosed by Johnson in order to sense a variation of temperature points (Johnson col 7 lines 53-60).
Regarding claim 2, Ranchod further discloses wherein the one or more sections of the thermochromic elements shows a change in color to locate the venous structure ([0032]: “strips, of encapsulated enantiotropic cholesteric liquid crystalline phase material exhibiting a mesophase color change at temperature(s) corresponding to human skin temperatures. The device 110 allows clinicians to both visualize the target vasculature and gain access to that vasculature.”).
Regarding claim 6, Ranchod further discloses wherein each unit of the thermochromic elements is isolated from another unit of thermochromic element (Fig 4b).
Regarding claim 8, Ranchod further discloses wherein the substrate layer is a low heat conductive layer ([0029]: “bottom (i.e., skin-contacting side) of the device 10 may also be coated with a substance that is adapted to cool the skin 18 and promotes thermal transfer, such as an alcohol-based gel”)
Regarding claim 9, Ranchod further discloses a frame structure for holding the substrate layer, wherein the frame structure defines an open area of the substrate layer that allows contact with subject's skin ([0011]: “a patch having a base or frame with adhesive backing that adheres to the patient's skin")
Regarding claim 10, Ranchod further discloses The device of claim 1, wherein the substrate layer comprises a plurality of perforations that facilitate the substrate layer to be peeled off from the subject's skin subsequent to securing a venous access device to the venous structure of the subject ([0034]: “in a perforated area 137 of the device 110.”).
Regarding claim 11, Ranchod discloses a thermal imaging dressing for locating a venous structure of a subject ([0009]: " an improved vein-visualization or vein-locating device that is intended for use during intravenous access medical procedures"), the thermal imaging dressing comprising: a substrate layer ([0016]: " a frame having a bottom surface and a top surface"); a plurality of sections of thermochromic elements arrayed on the substrate layer ([0016]: "one or more sections removably attached to the top surface of the frame. The sections are formed of a liquid crystal material that is sensitive to human skin temperature ranges."), wherein each section of the thermochromic elements is separated from another section of the thermochromic elements (Fig 4b); and an adhesive backing layer removably disposed on the top surface of the substrate layer ([0029]: “and an adhesive backing 15 (such as an adhesive fabric) that allows the edges 22 of the frame 13 to be removably attached to the patient's skin 18.”, Fig 1 element 15, wherein the backing is disposed on the same side as the thermochromic elements), the one or more sections of the thermochromic element being sensitive to subject's skin temperature to indicate the blood vessel; placing the substrate layer on subject's skin for locating the blood vessel; and inserting a venous access device into a desired position of the blood vessel that is indicated by the substrate layer.
Ranchod fails to disclose and wherein the plurality of sections of thermochromic elements comprises a first section of thermochromic elements that includes a first thermochromic unit arranged on the substrate layer and including first molecules; and a second thermochromic unit stacked with the first thermochromic unit and including second molecules, wherein, when the first and second thermochromic units are exposed to heat, the first and second molecules rotate and align at an angle to each other and exhibit a corresponding color.
Johnson discloses a first thermochromic unit arranged on the substrate layer (Fig 3D, col 8 lines 41-44: “thermochromic sensor layer 94,”) including first molecules (col 5 lines 21-42 and 49-50: “thermochromic sensor 32 is formed from liquid crystal thermochromic material… molecules of the liquid crystals”), and a second thermochromic unit overlaid atop the first thermochromic unit (Fig 3D, col 8 lines 41-44: thermochromic sensor layer 92) and including second molecules (col 5 lines 21-42 and 49-50: “thermochromic sensor 32 is formed from liquid crystal thermochromic material… molecules of the liquid crystals”), wherein, when the first and second thermochromic units are exposed to heat, the first and second molecules rotate and align at an angle, thereby exhibiting a color corresponding to the angle (col 3 lines 39-45: “The molecules of the liquid crystals are arranged in spiral stacks, and the color is determined by the pitch of this spiral--the length in which it makes one complete turn. As the temperature rises, the spiral twists and the pitch gets shorter. The crystal reflects only light with a wavelength the same as the pitch of the spiral.”.)
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the thermochromic elements disclosed by Ranchod to the plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer disclosed by Johnson in order to sense a variation of temperature points (Johnson col 7 lines 53-60).
Regarding claim 13, Ranchod further discloses wherein the section of thermochromic elements is disposed in a linear manner on the substrate layer (Fig 4b).
Regarding claim 14, Murphy further discloses wherein each unit of thermochromic elements is isolated from another unit of thermochromic element (Fig 3 wherein the dots are separated).
Regarding claim 15, Murphy further discloses wherein each unit of the thermochromic elements have a micro-replicated dot structure (Fig 3).
Regarding claim 16, Ranchod further discloses wherein the substrate layer is a low heat conductive layer ([0029]: “bottom (i.e., skin-contacting side) of the device 10 may also be coated with a substance that is adapted to cool the skin 18 and promotes thermal transfer, such as an alcohol-based gel”)
Regarding claim 17, Ranchod further discloses a frame structure for holding the substrate layer, wherein the frame structure defines an open area of the substrate layer that allows contact with subject's skin ([0011]: “a patch having a base or frame with adhesive backing that adheres to the patient's skin")
Regarding claim 19, Ranchod discloses a method for locating a blood vessel on a subject's body ([0009]: "an improved vein-visualization or vein-locating device that is intended for use during intravenous access medical procedures"), the method comprising: providing a substrate layer ([0016]: " a frame having a bottom surface and a top surface") having a plurality of sections of thermochromic elements positioned on the substrate layer ([0016]: "one or more sections removably attached to the top surface of the frame. The sections are formed of a liquid crystal material that is sensitive to human skin temperature ranges."), wherein each section of the thermochromic elements is separated from another section of the thermochromic elements (Fig 4b), the one or more sections of the thermochromic element is sensitive to subject's skin temperature to indicate the blood vessel ([0032]: "preferably includes one or more sections 130, preferably strips, of encapsulated enantiotropic cholesteric liquid crystalline phase material exhibiting a mesophase color change at temperature(s) corresponding to human skin temperatures"); placing the substrate layer on subject's (Fig 2).
Ranchod fails to disclose and the plurality of sections of thermochromic elements comprises a first section of thermochromic elements that includes a first thermochromic unit arranged on the substrate layer and including first molecules and a second thermochromic unit overlaid atop the first thermochromic unit and including second molecules; and rotating the first and second molecules at an angle to each other based on the first and second thermochromic units receiving the heat from the blood vessel, thereby causing the first section of thermochromic elements to exhibit a color.
Johnson discloses a plurality of sections of thermochromic elements (Fig 3D elements 88-94) comprises a first section of thermochromic elements (Fig 3D, col 8 lines 41-44: “thermochromic sensor layer 94,”) including first molecules (col 5 lines 21-42 and 49-50: “thermochromic sensor 32 is formed from liquid crystal thermochromic material… molecules of the liquid crystals”), and a second thermochromic unit overlaid atop the first thermochromic unit (Fig 3D, col 8 lines 41-44: thermochromic sensor layer 92) including second molecules (col 5 lines 21-42 and 49-50: “thermochromic sensor 32 is formed from liquid crystal thermochromic material… molecules of the liquid crystals”); and rotating the first and second molecules at an angle to each other based on the first and second thermochromic units receiving the heat from the blood vessel, thereby causing the first section of thermochromic elements to exhibit a color (col 3 lines 39-45: “The molecules of the liquid crystals are arranged in spiral stacks, and the color is determined by the pitch of this spiral--the length in which it makes one complete turn. As the temperature rises, the spiral twists and the pitch gets shorter. The crystal reflects only light with a wavelength the same as the pitch of the spiral.”, col 5 lines 49-52: “each of the thermochromic sensor layers would have thermochromic liquid crystals with a different red color start temperature”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the thermochromic elements disclosed by Ranchod to the plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer disclosed by Johnson in order to sense a variation of temperature points (Johnson col 7 lines 53-60).
Regarding claim 20, Ranchod further discloses removing the substrate layer from the subject's skin after the venous access device is inserted into the blood vessel ([0016]: “an adhesive disposed on the bottom surface of the frame to allow the frame to be removably attached to skin or a patient,”), wherein the substrate layer comprises a plurality of perforations that facilitates removal of the substrate layer (Fig 5 element 137).
Regarding claim 22, Johnson further discloses wherein each of the plurality of units are rotatable relative to one another (col 5 lines 49-52: “the molecules of the liquid crystals are arranged in spiral stacks, and the color is determined by the pitch of this spiral--the length in which it makes one complete turn.”).
Regarding claim 23, Johnson further discloses wherein the plurality of units includes: a first unit including a first arrangement of molecules (col 8 lines 44-46: “each of the thermochromic sensor layers would have thermochromic liquid crystals with a different red color start temperature”); and a second unit including a second arrangement of molecules different than the first arrangement of molecules (lines 44-46: “each of the thermochromic sensor layers would have thermochromic liquid crystals with a different red color start temperature”).
Regarding claim 24, Ranchod further discloses inserting a venous access device through the exhibited color and into the blood vessel ([0012]: “is formed with one or more ends that are adapted to affix an access device, such as a needle or catheter, to the patient's skin after the access device is inserted into the patient's vasculature.”)
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ranchod in view of Johnson in view of Murphy et al. (US 20250255541 A1), hereinafter Murphy.
Regarding claim 7, Ranchod as modified by Johnson discloses the device of claim 1, but fails to disclose wherein each unit of the thermochromic elements has a micro-replicated dot structure.
Murphy discloses a device comprising an array of thermochromic elements (abstract) wherein each unit of the thermochromic elements has a micro-replicated dot structure ([0091]: “For example, the TLC dot on the top right of the cluster 117 may refer to temperatures in the range of 20-25° C. The other three TLC dots 105 are black indicating that the temperature is out of range.”, Fig 3 cluster 117).
As Ranchod discloses a variety of configurations of thermochromic elements (Figs 4a, 4b, and 5), it would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the configuration of thermochromic elements disclosed by Ranchod as modified by Johnson to further include the micro-replicated dot structure Murphy in order to optimize temperature visualization by increasing the density of temperature sensing elements (Murphy [0029]).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ranchod in view of Johnson in view of Lambert et al. (US 20210346650 A1), hereinafter Lambert.
Ranchod as modified by Johnson discloses the thermal imaging dressing of claim 11 and further discloses a plurality of perforations that facilitates the substrate layer to be peeled off from the subject's skin subsequent to securing venous access device to the venous structure of the subject ([0034]: “The circular section 135 could be formed in a perforated area 137 of the device 110.”, Fig 5 element 137), but fails to disclose wherein the substrate layer comprises a tear-off tab for peeling the substrate layer from the subject's skin.
Lambert discloses a dressing (title) wherein the substrate layer comprises a tear-off tab for peeling the substrate layer from the subject's skin. ([0038]: “At least one protective tab and, in some instances a plurality of protective tabs 304 may not be coated with adhesive”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the thermal imaging dressing disclosed by Ranchod as modified by Johnson to include the tear off tab disclosed by Lambert in order to provide a location for a user to touch the dressing without the dressing sticking to the user's hands (Lambert [0034]).
Response to Arguments
Applicant's arguments filed 04/08/2026 have been fully considered but they are not persuasive.
Applicant argues on pages 8-9 of applicant’s remarks that Johnson fails to disclose the molecules rotate and align at an angle to each other and exhibit a corresponding color based on the angle. However, Johnson discloses that the color produced by the thermochromic elements is due to the spin of the molecules in response to heat (see rejection above). As such, the claim limitation is disclosed by Johnson and the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Czapp et al. (DE 102007035499 B3) – discloses molecules that rotate in order to produce color in a thermochromic sensor
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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