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 .
Election/Restrictions
Applicant’s election of Species A, claims 1-14 in the reply filed on 05/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/13/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/04/2025 and 10/22/2024 are considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, the limitation “further comprising a liquid crystal ink real-time temperature measuring scale” is indefinite as it is unclear what structure is required for this feature or how it is structurally related to the claimed temperature indication label. The instant specification does not provide clarity as to what is required for this feature.
As the scope of the claim is unclear, the metes and bounds of the claimed invention are unable to be determined and prior art is unable to be applied.
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, 2, 4, 5, 6, 7, 9, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Abdo et al. (US 2021/0396601; cited on IDS) in view of Lane et al. (US 2015/0368487, cited on ISR).
Regarding claims 1, 4, 5, 6, 9, , Abdo et al. teaches a printable irreversible thermochromic temperature indicator (label) comprising a base substrate (substrate) having an adhesive layer on the underside of the base substrate (substrate) to facilitate attachment to a product, such as a vaccine, medicine, pharmaceutical, food product or other temperature-sensitive product, a thermochromic composition (temperature indication composition) disposed on the upper surface of the substrate in a discrete pattern and a transparent top layer of polymer film provided thereon for protection from abrasion or damage (Abstract, Figure 1, [0008-0014, 0017, 0025-0032]). The base substrate (substrate) may have a color that that contrasts with the thermochromic composition (temperature indication composition), wherein the color of the substrate be due to the presence of a coating of paint, ink or dye applied to the substrate ([0028]).
The thermochromic composition (temperature indication composition) can be a dye or colorant such as leuco dyes as the colorant, weak organic acids as the color developer and solvents that variably interact with the components according to the temperature of the system, or the thermochromic dye is microencapsulated in a protective coating (i.e. binder) to protect the contents from undesired effects from the environment ([0038-45]). Abdo et al. teaches that the thermochromic composition (temperature indication composition) comes in various colors with various activation temperatures, clearing points and full color points, wherein some of the thermochromic compositions (temperature indication composition) are considered to be irreversible due to hysteresis, which is a phenomenon in which the value of a physical property lags behind changes in the effect causing it ([0043-0045]). Abdo et al. teaches that due to hysteresis, the thermochromic compositions(temperature indication composition) will provide a visual indication of exposure to a temperature at or below a threshold temperature and then maintain that visual indication even if the temperature later increases above that threshold temperature although the visual indication may reverse or disappear if the temperature increase above a second threshold at a higher temperature ([0044-0045]).
Abdo et al. does not expressly teach that the thickness of the base substrate (substrate) is 2 to 15 mil or that the thickness of the transparent top layer of polymer film is 10-90 mils, however, such modifications would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. It would have been obvious to modify the thickness of the substrate to fall within the claimed range as it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device (See MPEP 2144.04(III)(IV)(A)). Therefore, it would have been obvious to modify the thickness of the substrate based up on the required or desired thickness for the end use of the label. Additionally, with respect to the transparent top layer of polymer film, 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 thickness of the transparent top layer based upon the desired amount of protection from abrasion or damage.
Abdo et al. does not expressly teach that the thermochromic compound (temperature indication composition) comprises a binder and an organic compound, that have a refractive index that is the same or closely matching.
Lane et al. teaches a temperature indication label and is in the same field of endeavor as both Abdo et al. and the instant application. Lane et al. teaches printable ink for reversible thermal indicators, wherein the microcapsules comprise a wall material (organic compound) housing a core material, wherein the core material is the thermal change indicator, changing from an opaque solid to a transparent liquid at a predetermined temperature, and have a particle size of 5-50micrometers ([0007-0010, 0017-0025, 0027-0038]), which is encompassed by the claimed range of the instant application. Lane et al. teaches that the microcapsules includes a binder and rheology modifier as a carrier for the microcapsules, wherein the binder and rheology modifier include polyvinyl alcohol (binder) ([0009-0010]). Lane et al. teaches that the microcapsules can be formed from a variety of processes known in the art, and the wall of the microcapsules can be formed from gum, carbohydrate, cellulose material, lipid or protein ([0028]). Lane et al. teaches that the microcapsules are robust and thick enough to contain the core material without rupture or leakage ([0025]).
As both Abdo et al. and Lane et al. teach temperature indication labels containing microcapsules, 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 leuco dye microcapsules taught by Abdo et al. to have be comprised of the wall and binder compositions taught by Lane et al. to provide microcapsules that are robust and thick enough to contain the thermochromic composition without rupture or leakage.
With respect to the limitation stating that the refractive index of the binder and organic compound “are the same or closely matching”, while not expressly taught, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to choose materials from those taught by Lane et al. for the wall that have a refractive index that “is the same or closely matching” to the polyvinyl alcohol binder to reduce light scattering, reflection or refraction, thus affecting the viewing of the thermochromic material color change.
The limitation “the organic compound having hysteresis at a pre-selected temperature for an irreversible color change from colored to transparent within an operable range for a thermal mass to which the temperature indication label is intended for adhesion” claims the intended use of the invention, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is (see section §2173.05(g) of the MPEP). This is a functional limitation, and therefore was not evaluated on its own, but in conjunction with the remainder of claim 1. Abdo et al. in view of Lane et al. teach all the structural features of claim 1 as described above, and therefore, would be capable of performing in the manner claimed.
Regarding claim 2, Abdo et al. in view of Lane et al. teaches all the limitations of claim 1 above. While the references do not expressly teach that the dried thickness of the thermochromic composition is in the range of 3-8 mils as claimed, such a modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention based on the desired amount and effect of the thermochromic composition. One of ordinary skill in the art would be motivated to apply the thermochromic composition in an a dried thickness which results in the desired visual appearance for the resultant color change, wherein the desired thickness can be chosen to fall within the claimed range based on the desired end color.
Regarding claim 3, Abdo et al. in view of Lane et al. teaches all the limitations of claim 1 above, however, neither reference teaches that the wall material (organic compound) of the microcapsules has a purity of at least 92%. Such a modification would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as increasing the purity of the microcapsule wall material would decrease the amount of contaminants that may adversely affect the properties and function of the microcapsule wall material.
Regarding claim 7, Abdo et al. in view of Lane et al. teaches all the limitations of claim 1 above, and as stated above, Lane et al. teaches that the microcapsules particle size is 5-50micrometers ([0007-0010, 0017-0025, 0027-0038]).
The limitation reciting “wherein the temperature indication composition was deposited as an aqueous dispersion of the organic compound in the polyvinyl alcohol” is directed to a method of using and does not determine the patentability of the product, unless the method produces a structural feature of the product. The method of making and/or using the product is not germane to the issue of patentability of the product itself, unless Applicant presents evidence from which the Examiner could reasonably conclude that the claimed product differs in kind from those of the prior art. See MPEP § 2113. Furthermore, Abdo et al. in view of Lane et al. teaches all the structural features of the claims as stated in the rejection above, therefore, is capable of performing in the manner claimed.
Regarding claim 10, Abdo et al. in view of Lane et al. teaches all the limitations of claim 1 above, and Abdo et al. further teaches that the base substrate (substrate) is made from a polymer film, or paper or carboard or fabric ([0030]).
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Abdo et al. (US 2021/0396601) in view of Lane et al. (US 2015/0368487, cited on ISR) and further in view of Postle (US 4,643,588; cited on IDS and ISR).
Regarding claims 8 and 13, Abdo et al. in view of Lane et al. teaches all the limitations of claim 1 above, and Abdo et al. further teaches that the thermochromic compositions are functionally irreversible in their visual indication at progressively colder temperatures, wherein the thermochromic compositions provide a visual indication of exposure to a temperature at or below a first threshold and maintain the visual indication up to a temperature at or above a second threshold ([0012]). The ranges taught by Abdo et al. in paragraph [0012] overlap with the claimed range of 3-10 ˚C. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exits.
The limitation “and the thermal mass is a blood bag of blood” further limits the intended use limitation in lines 11-13 of claim 1, and has been considered, but is not given patentable weight as a structural limitation of the invention. The limitation defines the structural component by what it does, rather than what it is. Abdo et al. teaches that the product in which the printable irreversible thermochromic temperature indicator (label) is used on is a vaccine, medicine, pharmaceutical, food product or other temperature sensitive product ([0017]), and would therefore, be capable of performing in the manner claimed.
Abdo et al. in view of Lane et al. do not expressly teach that the organic compound is benzyl laurate. Postle et al. teaches a thermochromic label, wherein benzyl laurate is used as a solvent in thermochromic encapsulated composition (col. 2 Ln. 30-65, col. 3 Ln. 1-50, col. 9 Ln. 66-col. 10 Ln. 20). As both Abdo et al. and Postle et al. teach encapsulated thermochromic compositions, 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 microcapsule wall material of Abdo et al. to include the benzyl laurate as taught by Postle et al. as Postle et al. teaches benzyl laurate is an appropriate solvent used in thermochromic encapsulated compositions.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Abdo et al. (US 2021/0396601) in view of Lane et al. (US 2015/0368487, cited on ISR) and further in view of Li et al. (US 2020/0348187).
Regarding claim 11, Abdo et al. in view of Lane et al. teaches all the limitations of claim 1 above, and while Abdo et al. teaches that the thermochromic temperature indicator (label) comprises a transparent top layer of polymer film to protect against abrasion and other adventitious damage to the thermochromic composition ([0032]), the reference does not expressly teach that the transparent top layer is a material from the group consisting of polyurethane, silicone, acrylic, epoxy and combinations thereof.
Li et al. teaches a thermochromic label comprised of a porous film, a color composite material layer and a release film, wherein the thermochromic label can comprise a layer of protective film to ensure weather resistance, such as a polyurethane film (Figure 1, [0057]).
As both Abdo et al. and Li et al. are both in the field of thermochromic labels, 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 transparent top layer of polymer film taught by Abdo et al. to comprise the polyurethane protective layer taught by Li et al., as Li et al. teaches polyurethane films provide weather resistance to thermochromic labels.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Abdo et al. (US 2021/0396601) in view of Lane et al. (US 2015/0368487, cited on IDS and ISR) and further in view of Li et al. (CN 108342127A, cited on IDS and ISR, translation provided by Applicant).
Regarding claim 14, Abdo et al. in view of Lane et al. teaches all the limitations of claim 1 above, but the references do not expressly teach that the wall material (organic compound) of the microcapsules comprises the claimed materials. Li et al. teaches a thermochromic ink and compositions thereof, wherein pentacosane is used ([0004, 0085-0086]).
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 wall material of the microcapsule taught by Abdo et al. in view of Lane et al. to include pentacosane to provide an environmentally friendly composition (see Li et al. [0011]).
Conclusion
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LAURA POWERS
Examiner
Art Unit 1785
/LAURA C POWERS/Primary Examiner, Art Unit 1785
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