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 01/16/2026 has been entered. Amendments to claims 1, 6, 7, 11, 14-15, and 19, cancellation of claims 3-5 and 12-13, and new claims 22 and 23 are acknowledged. Claims 1,2, 6-11, 14-20, 22, and 23 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 Non-Final Office Action mailed 11/13/2025.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 and 23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 22 recites the limitation “wherein each of the plurality of units are rotatable relative to one another”. Page 8 lines 30-32 discloses that molecules may align and rotate when the thermochromic units comprise molecules such as cellulose nanorods or chiral organic molecules, there is no support for the units themselves rotating. Therefore the claim introduces new matter.
Claim 23 recites the limitation “a first unit including a first arrangement of molecules; and a second unit including a second arrangement of molecules different than the first arrangement of molecules.”. Applicant’s disclosure does not contain support for this limitation. Page 5 lines refer to the molecules contained within leuco-dyes and liquid crystals, and page 8 lines 22-35 refer to molecules contained within the thermochromic elements. Neither reference discloses a different arrangement of molecules for each unit.
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 Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-2, 6-11, 13-17, and 19-20 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), hereinafter Ranchod, in view of Murphy et al. (US 20250255541 A1), hereinafter Murphy.
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 having a top and bottom surface ([0016]: " a frame having a bottom surface and a top surface"); and a plurality of sections of thermochromic elements positioned on the top surface of 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).
Ranchod fails to disclose and wherein each section of the thermochromic elements comprises a plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer.
Murphy discloses a device comprising an array of thermochromic elements (abstract) wherein a section of the thermochromic elements comprises a plurality of units of thermochromic elements on the substrate layer ([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), and wherein each section of the thermochromic elements comprises a plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer (Fig 3 cluster 117, wherein the units can be taken to run up and down on a vertical axis, and wherein the units are linear).
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 to further include the plurality of units as disclosed by Murphy in order to optimize temperature visualization by increasing the density of temperature sensing elements (Murphy [0029]).
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, Murphy further discloses wherein each unit of the thermochromic elements is isolated from another unit of thermochromic element (Fig 3 wherein the dots are separated).
Regarding claim 7, Murphy further discloses wherein each unit of the thermochromic elements have a micro-replicated dot structure (Fig 3).
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 having a top and bottom surface ([0016]: " a frame having a bottom surface and a top surface"); a plurality of sections of thermochromic elements arrayed on the top surface of 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 each section of the thermochromic elements comprises a plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer.
Murphy discloses a device comprising an array of thermochromic elements (abstract) wherein a section of the thermochromic elements comprises a plurality of units of thermochromic elements on the substrate layer ([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), and wherein each section of the thermochromic elements comprises a plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer (Fig 3 cluster 117, wherein the units can be taken to run up and down on a vertical axis, and wherein the units are linear).
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 to further include the plurality of units as disclosed by Murphy in order to optimize temperature visualization by increasing the density of temperature sensing elements (Murphy [0029]).
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 a top surface of 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 skin for locating the blood vessel (Fig 2); and inserting a venous access device into a desired position of the blood vessel that is indicated by the substrate layer (Fig 2 element 16).
Ranchod fails to disclose and wherein each section of the thermochromic elements comprises a plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer.
Murphy discloses a device comprising an array of thermochromic elements (abstract) wherein a section of the thermochromic elements comprises a plurality of units of thermochromic elements on the substrate layer ([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), and wherein each section of the thermochromic elements comprises a plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer (Fig 3 cluster 117, wherein the units can be taken to run up and down on a vertical axis, and wherein the units are linear).
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 to further include the plurality of units as disclosed by Murphy in order to optimize temperature visualization by increasing the density of temperature sensing elements (Murphy [0029]).
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).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ranchod in view of Murphy in view of Lambert et al. (US 20210346650 A1), hereinafter Lambert.
Ranchod as modified by Murphy 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 Murphy 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]).
Claim(s) 1 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ranchod 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 having a top and bottom surface ([0016]: " a frame having a bottom surface and a top surface"); and a plurality of sections of thermochromic elements positioned on the top surface of 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).
Ranchod fails to disclose and wherein each section of the thermochromic elements comprises a plurality of units of thermochromic elements that extend vertically in a linear manner from the substrate layer.
Johnson discloses a plurality of thermochromic elements that extend vertically in a linear manner from a substrate layer (Fig 3D, col 8 lines 41-44: “thermochromic sensor layer 94, thermochromic sensor layer 92, thermochromic sensor layer 90, thermochromic sensor layer 88 and thermochromic sensor layer 8”).
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 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”).
Response to Arguments
Applicant's arguments filed 01/16/2026 have been fully considered but they are not persuasive.
Applicant argues that Murphy fails to disclose a plurality of units of thermochromic units that extend vertically in a linear manner from the substrate. However, as cited above, the cluster of dots disclosed by Murphy are vertical and linear when taken from a top down arrangement. Per MPEP 2173.01, “a claim must be given its broadest reasonable interpretation consistent with the specification as it would be interpreted by one of ordinary skill in the art”. Nonetheless, an additional rejection has been made in view of 35 U.S.C. § 103 over Ranchod in view of Johnson considering the thermochromic units in a stacked configuration, consistent with Figs 3 and 4 of applicant’s specification.
Conclusion
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jaqueline Cheng can be reached at 571-272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAVYA SHOBANA BALAJI/Examiner, Art Unit 3791
/DANIEL L CERIONI/Primary Examiner, Art Unit 3791