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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2/6/2026 has been entered.
Response to Amendment
This is an office action in response to applicant's arguments and remarks filed on 2/6/2026. Claims 1-11, 14-16, and 18-23 are pending in the application, with claim 23 being withdrawn.
Status of Objections and Rejections
All rejections from the previous office action are maintained while new grounds of rejection under 35 U.S.C. 103 are necessitated by and for the amendments.
Response to Arguments
Applicant's arguments filed 2/6/2026 have been fully considered but they are not persuasive.
The Applicant asserts that because the indicator dyes of claims 12 and 13, other than methylene blue and crystal violet, being incorporated into claim 1 renders the presently claimed invention fully and patentably distinguishes over the asserted prior art.
While the Examiner agrees that the Amendment overcomes the rejection on record, the Examiner points to the reference of Lurvey et al. (US20080021381) teaches that the dye compound of the sterilization indicator comprises a dye including methyl orange, where methyl orange is a known and conventional dye in the art, see [0294] in Lurvey et al., which is listed in newly amended Claim 1. Therefore, the newly added claim limitation is rejected in the action below under U.S.C. 103.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11, 14-16, and 18-22 are rejected under 35 U.S.C. 103 as being unpatentable over Larsson et al. (US 3,981,683, cited on IDS) and further in view of Lurvey et al. (US 2008/0021381) and Huffman et al. (US PG Pub 2012/0079981).
Regarding clam 1, Larsson et al. teaches a chemical indicator (sterility indicator, see Fig. 1 and Col. 3, Lines 5-10), comprising: a non-cellulosic backing layer (foil backing strip 1, see Fig. 1 and Col. 3, Lines 10-30);
a non-cellulosic cover layer overlying the backing layer (cover strip 6 comprising transparent polypropylene, see Col. 4, Lines 10-25) the backing layer and/or the cover layer comprising a gas permeable polymeric film (the cover later allows gas to pass through, see Col. 3, Lines 60-66);
a non-cellulosic wicking material positioned between the backing layer and the cover layer (wicking means 3 between cover 6 and backing 1 comprises an inorganic fibrous composition, see Col. 3, Lines 10-19 and 41-46);
a dye composition positioned between the backing layer and the cover layer and in contact with or nearly in contact with the wicking material (a pellet of organic compound 5, see Col. 3, Lines 10-30, where the pellet also comprises a dye, see Col. 6, Lines 35-45), the dye composition comprising an indicator dye which changes color in the presence of hydrogen peroxide (dye comprises methylene blue or crystal violet, see Col. 6, Lines 40-55, where methylene blue and crystal violet are known hydrogen peroxide indicator dyes, see Page 7 of the Instant Specification), and a base medium, which melts at a temperature (organic compound 5 is chosen to melt at a temperature based on the sterilant chosen, see Col. 4, Lines 47-68);
the cover layer including a transparent portion to permit observation of the wicking material (cover strip 6 comprising transparent polypropylene to allow visualization of the organic compound, see Fig. 1 and Col. 4, Lines 10-25);
and an adhesive for adhering the cover layer to the backing layer (thin layer of adhesive 2 for connecting cover 6 and backing 1, see Col. 3, Lines 10-19).
While the prior art of Larsson teaches that the wicking means may be any suitable material through which the organic compound can migrate by capillary action and teaches that the dye used can be any dye soluble in an organic compound, it does not explicitly teach that the wicking material comprises nylon, polyethersulfone, polyvinylidene fluoride or a mixture of two or more thereof and wherein the indicator dye comprises lissamine green, resazurin, resorufin, diphenylamine sulfonate, diphenylamine, nitrodiphenylamine, methyl orange, neutral red, iron(II) phenanthroline, thionine, or a mixture of two or more thereof.
However, in the analogous art of sterility indicators, Lurvey et al. teaches a device used for detecting a contaminant in a liquid sample wherein the device comprises a porous layer made of polyvinylidene fluoride (PVDF) with dye particles mixed therein, see [0104] and Example 1, where the use of PVDF allows the substrate to be exposed to the sterilant to allow for a sufficient color change, see [0177]). Lurvey et al. also teaches a dissolvable dye composition including methyl orange, see [0247]. Therefore, the prior art references teach the claimed elements.
The combination of the known elements is achieved by a known method of first providing multiple layers used to adsorb a sterilant fluid to then display a colorimetric reaction with a dye solubilized by the organic compound in the indicator. The claimed elements would continue to operate in the same manner as the dye compound of the porous layer would have functioned in the same manner as it is meant to display a color change in response to a selected stimulus and therefore would have facilitated the expected result of exhibiting a color change in response to being exposed to a sterilant. Therefore, the results would have been predictable to one of ordinary skill in the art.
Based on the above findings, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to have substituted the porous polymer of Larsson because both elements were known equivalents for providing a substrate for a mobile phase to pass thereon to notify a user of a completed sterilization cycle. The substitution would have resulted in the predictable result of providing a material for the capillary movement of the dye composition of the indicator.
Further, because the dye compound of Larsson et al. is not limited to the dye listed within the invention, and methyl orange is a known solvatochromic compound used in sterilization indicators, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the dye compound of Larsson et al. to incorporate the methyl orange of Lurvey et al. The modification of the dye would have resulted in the predictable result of providing a color change in response to sterilization.
An additional difference between the prior art and the instant application is that the reference of Larsson et al. does not explicitly teach that the indicator comprises a base medium, which melts at a temperature in the range from about 45°C to about 65°C.
However, in the analogous art of temperature activated indicators, Huffman et al. also teaches a time-temperature indicator that comprises side chain crystallizable polymer comprising an organic group, similar to the organic compound of Larsson et al., see [0247] – [0253] in Huffman et al., where the additional side chain crystallizable copolymers of dodecylacrylate and docosylacrylate melt at 45.9° - 56°C, see Table 2 and [0233] – [0234]).
Accordingly, the prior art references teach all of the claimed elements. Furthermore, the combination of all the claimed elements would continue to operate in the same manner.
Specifically, both references teach the implementation of an organic polymer that melts following exposure to a specific temperature of sterilization to provide visual indication that the object has been exposed to a sterilization process; therefore, the resulting indicator would be predictable to one of ordinary skill in the art.
Based on the above findings, it would have been obvious to one of ordinary skill in the art to modify the polymer used within the prior art of Larsson et al. to include the side chain crystallizable copolymer of dodecylacrylate and docosylacrylate of Huffman et al. for the benefit of indicating to a user of a contaminated material due to the melting of the side-chain polymer in response to temperatures that are above refrigerated levels, see [0387] - [0393] in Huffman et al. Further, the modification of the side-chain polymer of Larsson et al. to melt between the temperatures of 45°C to about 65°C as exemplified by Huffman et al. would have resulted in the predictable result of successfully facilitating an indicator reaction at or above a certain temperature and also results in no more than the predictable use of the prior-art elements according to their established functions.
Further, while the reference of Larsson et al. teaches that the dye used can be any dye soluble in an organic compound, the reference does not teach that the dye
Regarding claim 2, modified Larsson et al. teaches the chemical indicator of claim 1 wherein the backing layer includes a depression for receiving the wicking material and the dye composition (pocket 4, or depression, in backing strip 1 for holding organic compound 5 and wicking means 3, see Fig. 1, Col. 3, Lines 10-19, and Col. 5, Lines 63-68).
Regarding claim 3, modified Larsson et al. teaches the chemical indicator of claim 1, wherein the backing layer comprises a metallic foil (backing layer comprises aluminum (metallic) foil, see Col. 3, Lines 20-31).
Regarding claim 4, modified Larsson et al. teaches the chemical indicator of claim 1, comprising a backing layer, but the current embodiment of Larsson et al. does not teach the prior art element of the backing strip comprises a polymer such as polypropylene.
However, the prior art reference of Larsson et al. teaches that the backing layer can consist of the same material of the cover layer, which consists of polypropylene since it has a high softening point and is relatively inert to most chemical compounds, see Col. 3, Lines 20-33 and Col. Lines 10-28.
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the backing strip comprising the metal foil to have instead comprised the polypropylene for the benefit of providing a backing layer that has an appropriate heat and chemical tolerance for the process of sterilization, see Col. 3, Lines 20-33 and Col. Lines 10-28. Additionally, the modification of the backing layer to incorporate the same material as the cover layer would have had the reasonable expectation of success because the composition of the backing strip is not critical and it is known that polypropylene is stable under sterilization conditions, see Col. 3, Lines 20-33 and Col. Lines 10-28.
Regarding claim 5, modified Larsson et al. teaches the chemical indicator of claim 1 wherein the backing layer comprises an aluminum foil (backing layer comprises aluminum foil, see Col. 3, Lines 20-31).
Regarding claim 6, modified Larsson et al. teaches the chemical indicator of claim 1, wherein the cover layer comprises a polyolefin (cover layer comprises polypropylene, a polyolefin, see Col. 4, Lines 10-28 and Principles of Polymerization).
Regarding claim 7, modified Larsson et al. teaches the chemical indicator of claim 1, wherein the cover layer comprises polypropylene (cover layer comprises polypropylene, see Col. 4, Lines 10-28).
Regarding claim 8, modified Larsson et al. teaches the chemical indicator of claim 1, wherein the cover layer comprises polypropylene (cover layer comprises polypropylene, see Col. 4, Lines 10-28).
Regarding claim 9, modified Larsson et al. teaches the chemical indicator of claim 1 comprising a backing layer, but does not teach that the backing layer is gas permeable to permit vaporous hydrogen peroxide to pass through the backing layer and contact the wicking material.
However, the prior art reference of Larsson et al. teaches that the backing layer can consist of the same material of the cover layer, which is vapor permeable (constructed of polypropylene, a vapor permeable material, see Col. 3, Lines 20-33 and Col. Lines 10-28) to permit vaporous hydrogen peroxide to pass through the backing layer and contact the wicking material since it has a high softening point and is relatively inert to most chemical compounds, see Col. 3, Lines 20-33 and Col. Lines 10-28.
Further, permitting vaporous hydrogen peroxide to pass through is a functional recitation of the backing layer; a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the function, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963).
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the backing strip comprising the metal foil to have instead comprised the polypropylene for the benefit of providing a backing layer that has an appropriate heat and chemical tolerance for the process of sterilization, see Col. 3, Lines 20-33 and Col. Lines 10-28. Additionally, the modification of the backing layer to incorporate the same material as the cover layer would have had the reasonable expectation of success because the composition of the backing strip is not critical and it is known that polypropylene is stable under sterilization conditions, see Col. 3, Lines 20-33 and Col. Lines 10-28.
Regarding claim 10, modified Larsson et al. teaches the chemical indicator of claim 1 wherein the cover layer is gas permeable to permit vaporous hydrogen peroxide to pass through the cover layer and contact the wicking material (the cover strip is vapor, or gas, permeable, see Col. 4, Lines 2-39, and is therefore permeable to permit vaporous hydrogen peroxide to pass through the backing layer and contact the wicking material, where permitting vaporous hydrogen peroxide to pass through is a functional recitation of the backing layer; a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the function, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963).).
Regarding claim 11, modified Larsson et al. teaches the chemical indicator of claim 1 wherein the base medium comprises a thermoplastic polymer (the side chain copolymers are dodecylacrylate and docosylacrylate, which melt at 45.9° - 56°C, see Table 2 and [0233] – [0234] in Huffman et al., and are therefore thermoplastic polymers as they melt at lower melting points).
Regarding claim 14, modified Larsson et al. teaches that chemical indicator of claim 1 wherein the dye composition further comprises a contrast dye (pH sensitive dye included along wicking means, see Col. 6, Lines 67-56 in Larsson et al.).
Regarding claim 15, modified Larsson et al. teaches that chemical indicator of claim 14 wherein the dye composition further comprises a contrast dye (pH sensitive dye included along wicking means, see Col. 6, Lines 47-56 in Larsson et al.), but does not explicitly teach that the contrast dye comprises phenol red, metacresol purple, bromophenol blue, thymolphthalein, bromothymol blue, thymol blue, bromocresol purple, malachite green oxalate, or a mixture of two or more thereof. However, the Instant Application states that phenol red is a contrast dye provides an indication that exposure to VHP has been achieved and shows a color that is not indicative of the first dye.
Further, Larsson et al. teaches that the contrast dye can comprise phenol red (dye comprises phenol red, see Col. 6, Lines 46-56)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the instant application to choose phenol red from the finite number of predictable dye compounds listed by Larsson et al. that react to show the sterilization of an object with a reasonable expectation of successfully producing a visual indication in response to an object being sterilized.
Regarding claim 16, modified Larsson et al. teaches the dye composition of claim 1 wherein the dye composition is in the form of a pellet (organic composition is a pellet 5, see Fig. 1 and Col. 3, Lines 10-19, where the pellet also comprises a dye, see Col. 6, Lines 35-45).
Regarding claim 18, modified Larsson teaches the chemical indicator of claim 1, wherein the wicking material is made of a porous material to allow fluid passage, see Col. 3, Lines 41-56, but does not teach that the wicking material has an average pore size in the range from about 0.1 to about 3 micrometers.
However, the analogous art of Lurvey et al. teaches a device wherein the material for capturing the sterilant has an average pore size in the range from about 0.1 to about 3 micrometers (the porous membrane layer has a pore size of 0.2 microns, which falls within the instant range, see [0099]).
Therefore, it would have been obvious to a person possessing ordinary skill in the art before the effective filing date of the instant application to have modified the wicking material of Larsson et al. to comprise the polyethersulfone with a pore size of 0.2 microns as exemplified by Lurvey et al. for the benefit of insuring that no dye composition is lost to the porous matrix, see [0099]. Further, the modification of the wicking member of Larsson et al. to include the PES with a pore size 0.2 microns of Lurvey et al. would have led to the predictable result of creating a sterilization indication device with a sterilant-permeable channel.
Regarding claim 19, modified Larsson et al. teaches the chemical indicator of claim 1 wherein the wicking material is in the form of a rectangular strip (the wicking material 3 is in the shape of a rectangle, see Fig. 1).
Regarding claim 20, modified Larsson et al. teaches the chemical indicator of claim 1 wherein the wicking material is in the form of a circular layer (the wicking material 3 is placed within the circular depression for the pellet 5, see Fig. 1 and Col. 5, Lines 60-67).
Regarding claim 21, modified Larsson et al. teaches the chemical indicator of claim 1, wherein upon exposure of the chemical indicator to vaporous hydrogen peroxide at a temperature in the range from about 45°C to about 65°C, the base medium melts and the dye composition wicks along the wicking strip and changes color in response to exposure to the vaporous hydrogen peroxide (the modified indicator melts in the range of 45.9° - 56°C, see Table 2 and [0233] – [0234] in Huffman, where the dye reacts as the organic compound moves across the wicking strip at a sufficient temperature, see Col. 6, Lines 35-45 in Larsson et al.).
“Exposure to vaporous hydrogen peroxide” is a limitation with respect to an intended use of the chemical indicator comprising the base medium. An intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458,459 (CCPA 1963). The apparatus of modified Larsson et al. is identical to the presently claimed structure and therefore, would have the ability to perform the use recited in the claim since the base medium (indicator) melts in the range of 45.9° - 56°C, see Table 2 and [0233] – [0234] in Huffman, and the dye composition reacts to a vaporous compound.
Regarding claim 22, modified Larsson et al. teaches the chemical indicator of claim 1 wherein the chemical indicator is a moving front chemical indicator (pellet moves through wick and picks up dye, and is therefore a moving front indicator, see Col. 6, Lines 40-55).
Conclusion
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/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758