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 .
Response to Amendment
The amendment filed 07/14/2026 has been entered. Amendments to claims 1, 2,6,7,9, 11, 14, 15, 17-19, and 23-24 are acknowledged. Claims 1,2, 6-11, 14-20, and 23-24 remain pending in the application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 11, 14, 16-19, and 24 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ranchod et al. (US20080146913A1, as cited by applicant’s IDS filed 08/22/2023)
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") defining a plurality of perforations ([0034]: “The circular section 135 could be formed in a perforated area 137 of the device 110”); 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 that facilitates adhesion of the substrate layer onto the skin of the subject ([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). wherein the substrate layer comprises the plurality of perforations permits 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 14, Ranchod further discloses wherein a first section of thermochromic elements comprises a first unit of thermochromic elements and a second unit of thermochromic elements ([0019]: “The liquid crystal containing material is formed as a single continuous sheet with numerous pores, or holes, in the continuum of the sheet. The pores allow direct access to the skin”, and wherein the first unit of thermochromic elements is isolated from the second unit of thermochromic elements (Fig 4B).
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 of a subject using a thermal imaging dressing ([0009]: " an improved vein-visualization or vein-locating device that is intended for use during intravenous access medical procedures") that includes a substrate layer ([0016]: " a frame having a bottom surface and a top surface") defining perforations 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.", [0034]: “The circular section 135 could be formed in a perforated area 137 of the device 110”), wherein each section of the thermochromic elements is separated from another section of the thermochromic elements (Fig 1), wherein the method comprises: placing the substrate layer on skin of the subject, thereby causing the plurality of sections of thermochromic elements to indicate a location of the blood vessel (Fog 3); inserting a venous access device through the thermal imaging dressing and into the blood vessel (Fig 6b); and tearing the substrate layer along the perforations and around the venous access device, thereby removing the substrate layer from the skin with the venous access device still inserted within the blood vessel ([0033-0034]: “allows each individual section 130 to be removed from the patch frame 132 (see FIG. 3) individually… in a perforated area 137 of the device 110.”).
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 Rejections - 35 USC § 103
Claim(s) 1-2, 6, 8-10, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ranchod in view of Johnson (US 5394824 A) in further view of Gallagher (US 20180207052).
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).
Ranchod in view of Johnson fails to disclose wherein the second thermochromic unit exhibits an inverted curved shape with a peak surface configured to contact skin of the subject.
Gallagher discloses a thermochromic unit ([0037]: “both the base and the protrusions are formed of the thermoplastic elastomer with the thermochromic pigment.”) that exhibits an inverted curved shape with a peak surface configured to contact skin of the subject ([0073]: “and protrusions 616 may be curved, such as semi-spherical”).
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date to modify the device disclosed by Ranchod in view of Johnson to include the inverted curved shape with a peak surface as disclosed by Gallagher in order to improve patient comfort by blunting the tip of the element in contact with the user (Gallagher [0065]).
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 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”).
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) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ranchod in view of Murphy.
Regarding claim 15, Ranchod discloses the device of claim 11, 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 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, see Remarks pages 8-9, filed 07/14/2026, with respect to the rejection(s) of claim(s) 1,2, 6-11, 14-20, 23, and 24 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 U.S.C. § 103 (see above)
Applicant's arguments with respect to the rejection of claim 11 and 19 have been fully considered but they are not persuasive. Applicant argues on page 9 of Remarks that the peeling off of the layers disclosed by Ranchod occurs before the insertion of the device and therefore is not disclosed by the amended claim limitation. However, per ([0033]: “allows each individual section 130 to be removed from the patch frame 132 (see FIG. 3) individually”). As the device has several sections, a different section may be removed after insertion of the device without affecting the device, which is equivalent to “permitting the substrate layer to be peeled off the skin subsequent to securing a venous access device”. MPEP 2183 states that a prior art element is equivalent when (A) The prior art element performs the identical function specified in the claim in substantially the same way, and produces substantially the same results as the corresponding element disclosed in the specification. Kemco Sales, Inc. v. Control Papers Co., 208 F.3d 1352, 1364, 54 USPQ2d 1308, 1315 (Fed. Cir. 2000). Additionally, while Ranchod discloses that the device may be secured after removing a section, as the sections may be removed individually, there is nothing preventing removal post insertion. 1) "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). As such the rejection is maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Jensen et al. (US 20090198190 A1) – discloses removal of a substrate after insertion of a device without affecting the device placement ([0137]: “By separating the release layer into the second (20) and third (21) sections along the central axis of the mounting pad, it is made possible to quickly and automatically remove the release layer without influencing the movement of the needle during insertion, and avoiding oblique forces acting on the cannula.”)
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAVYA SHOBANA BALAJI whose telephone number is (703)756-5368. The examiner can normally be reached Monday - Friday 8:30 - 5:30 ET.
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/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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