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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/19/25 has been entered.
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.
Claims 1, 2, 25, 26, 27, 28, 29, 30, 31, 32, 34, 35, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hynes (US 2014/147882; previously cited), in view of Wilson (US Pub 2007/0166780; previously cited), and further in view of Lund (US Patent 5,443,963).
Regarding Claim 1, Hynes teaches a culture device comprising a growth compartment ([0040] The invention employs a tool specially adapted for use in detecting the presence of microorganisms, particularly thermoduric microorganisms, in a product. The tool is a small vessel 10 defining a retention chamber 19 and equipped with a probe 30 sensitive to a target-analyte in operable communication with the retention chamber 19.)
at least one of the oxygen impermeable barriers being configurable between an open configuration where the growth compartment is exposed to an environment outside of the growth compartment and a closed configuration wherein the growth compartment is sealed from exchanging oxygen with the environment outside of the growth compartment;
a culture medium capable of supporting replication of at least one microorganism disposed within the growth compartment ([0055] culture media); and
an oxygen-sensitive dye disposed within the growth compartment ([0044] The probe 30 can be any device capable of sensing and reporting changes in a target-analyte concentration within an enclosed volume. In a preferred embodiment, the probe 30 is an optically-active, target-analyte sensitive material configured and arranged to experience changes in target-analyte concentration or partial pressure PA in an aliquot A placed within the retention chamber 19 of the vessel 10. The analyte-sensitive material is preferably a photoluminescent dye embedded within an analyte permeable polymer matrix. [0045] The oxygen-sensitive photoluminescent dye may be selected from any of the well-known oxygen sensitive photoluminescent dyes. One of routine skill in the art is capable of selecting a suitable dye based upon the intended use of the probe 30. A nonexhaustive list of suitable oxygen sensitive photoluminescent dyes).
Hynes is silent to surrounded by one or more oxygen impermeable barriers.
Wilson teaches in the related art of cellular microorganisms. [0090] In yet another embodiment of the invention, the above-described system using oxygen-impermeable plates or tubes to form the hollow form and contain the gel is modified to further include an oxygen-consuming reaction in the culture medium. For example, the oxygen consuming reaction could be the addition of glucose, plus glucose oxidase and catalase (to remove the resultant hydrogen peroxide), or ascorbate, plus ascorbate oxidase, in the gelling medium. For this embodiment of the invention, the plates are made of oxygen-impermeable materials, such as glass, plastic, or ceramics.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the growth compartment in the device of Hynes to be surrounded by one or more oxygen impermeable barriers, as taught by Wilson, to allow for an oxygen-consuming reaction inside the culture device, as taught by Hynes, in [0090].
Hynes, in view of Wilson, is silent to wherein said culture medium is a thin film culture medium (the culture medium can be applied such that it is a thin layer above a layer of cells, for example).
Lund teaches in the related art of method of identifying and detecting bacteria. See col. 1, lines 4-6. Staphyococcus aureus variants were obtained from the Centers For Disease Control, Atlanta, Ga. and maintained as part of a private collection at Minnesota Mining and Manufacturing Company (3M, St. Paul, Minn.) were tested for .beta.-D-glucosidase activity using three systems, agar, broth and PETRIFILM thin film culture medium devices (described in Example 1). The agar contained 5-bromo-4-chloro-3-indolyl-.beta.-D-glucopyranoside (x-glucoside) as the substrate. Col. 2, lines 25-30.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the culture medium in the device of modified Hynes, with PETRIFILM thin film culture medium device, as taught by Lund, to detect bacterial growth, as taught by Lund, in Col. 2, lines 30-36.
Regarding Claim 2, modified Hynes teaches the culture device of claim 1, wherein the oxygen sensitive dye comprises an oxygen sensitive luminophore ([0044] The probe 30 can be any device capable of sensing and reporting changes in a target-analyte concentration within an enclosed volume. In a preferred embodiment, the probe 30 is an optically-active, target-analyte sensitive material configured and arranged to experience changes in target-analyte concentration or partial pressure PA in an aliquot A placed within the retention chamber 19 of the vessel 10. The analyte-sensitive material is preferably a photoluminescent dye embedded within an analyte permeable polymer matrix. [0045] The oxygen-sensitive photoluminescent dye may be selected from any of the well-known oxygen sensitive photoluminescent dyes. One of routine skill in the art is capable of selecting a suitable dye based upon the intended use of the probe 30. A nonexhaustive list of suitable oxygen sensitive photoluminescent dyes).
Regarding Claim 25, modified Hynes teaches the culture device of claim 1, wherein the culture medium comprises agar or a water-gelling thin film (Staphyococcus aureus variants were obtained from the Centers For Disease Control, Atlanta, Ga. and maintained as part of a private collection at Minnesota Mining and Manufacturing Company (3M, St. Paul, Minn.) were tested for .beta.-D-glucosidase activity using three systems, agar, broth and PETRIFILM thin film culture medium devices (described in Example 1). The agar contained 5-bromo-4-chloro-3-indolyl-.beta.-D-glucopyranoside (x-glucoside) as the substrate. Col. 2, lines 25-30.)
Regarding Claim 26, 27, 28, and 29, modified Hynes teaches the culture device of claim 1, wherein the oxygen-sensitive luminophore is an oxygen-sensitive phosphor, wherein the oxygen-sensitive phosphor comprises at least one of a porphyrin, a pi-conjugated molecule, or a pi-conjugated polymer, wherein the oxygen-sensitive phosphor comprises a porphyrin, wherein the oxygen-sensitive dye comprises a pi-conjugated ligand ([0045] The oxygen-sensitive photoluminescent dye may be selected from any of the well-known oxygen sensitive photoluminescent dyes. One of routine skill in the art is capable of selecting a suitable dye based upon the intended use of the probe 30. A nonexhaustive list of suitable oxygen sensitive photoluminescent dyes includes specifically, but not exclusively, ruthenium(II)-bipyridyl and ruthenium(II)-diphenylphenanothroline complexes, porphyrin-ketones such as platinum(II)-octaethylporphine-ketone, platinum(II)-porphyrin such as platinum(II)-tetrakis(pentafluorophenyl)porphine, palladium(II)-porphyrin such as palladium(II)-tetrakis(pentafluorophenyl)porphine, phosphorescent metallocomplexes of tetrabenzoporphyrins, chlorins, azaporphyrins, and long-decay luminescent complexes of iridium(III) or osmium(II).)
Regarding Claim 30, modified Hynes teaches the culture device of claim 2, further comprising a metal conjugated to the oxygen sensitive luminophore, wherein the metal is optionally a transition metal or lanthanide ([0045] The oxygen-sensitive photoluminescent dye may be selected from any of the well-known oxygen sensitive photoluminescent dyes. One of routine skill in the art is capable of selecting a suitable dye based upon the intended use of the probe 30. A nonexhaustive list of suitable oxygen sensitive photoluminescent dyes includes specifically, but not exclusively, ruthenium(II)-bipyridyl and ruthenium(II)-diphenylphenanothroline complexes, porphyrin-ketones such as platinum(II)-octaethylporphine-ketone, platinum(II)-porphyrin such as platinum(II)-tetrakis(pentafluorophenyl)porphine, palladium(II)-porphyrin such as palladium(II)-tetrakis(pentafluorophenyl)porphine, phosphorescent metallocomplexes of tetrabenzoporphyrins, chlorins, azaporphyrins, and long-decay luminescent complexes of iridium(III) or osmium(II). Platinum is a metal.)
Regarding Claim 31, modified Hynes teaches the culture device of claim 29, wherein the pi-conjugated molecule comprises a porphyrin ([0045] The oxygen-sensitive photoluminescent dye may be selected from any of the well-known oxygen sensitive photoluminescent dyes. One of routine skill in the art is capable of selecting a suitable dye based upon the intended use of the probe 30. A nonexhaustive list of suitable oxygen sensitive photoluminescent dyes includes specifically, but not exclusively, ruthenium(II)-bipyridyl and ruthenium(II)-diphenylphenanothroline complexes, porphyrin-ketones such as platinum(II)-octaethylporphine-ketone, platinum(II)-porphyrin such as platinum(II)-tetrakis(pentafluorophenyl)porphine, palladium(II)-porphyrin such as palladium(II)-tetrakis(pentafluorophenyl)porphine, phosphorescent metallocomplexes of tetrabenzoporphyrins, chlorins, azaporphyrins, and long-decay luminescent complexes of iridium(III) or osmium(II).)
Regarding Claim 32, modified Hynes teaches the culture device of claim 2, wherein the oxygen sensitive luminophore is Pd-meso-tetra-(4-carboxypenyl)porphyrin dendrimer ([0045] The oxygen-sensitive photoluminescent dye may be selected from any of the well-known oxygen sensitive photoluminescent dyes. One of routine skill in the art is capable of selecting a suitable dye based upon the intended use of the probe 30. A nonexhaustive list of suitable oxygen sensitive photoluminescent dyes includes specifically, but not exclusively, ruthenium(II)-bipyridyl and ruthenium(II)-diphenylphenanothroline complexes, porphyrin-ketones such as platinum(II)-octaethylporphine-ketone, platinum(II)-porphyrin such as platinum(II)-tetrakis(pentafluorophenyl)porphine, palladium(II)-porphyrin such as palladium(II)-tetrakis(pentafluorophenyl)porphine, phosphorescent metallocomplexes of tetrabenzoporphyrins, chlorins, azaporphyrins, and long-decay luminescent complexes of iridium(III) or osmium(II).)
Regarding Claim 34, modified Hynes teaches the culture device of claim 1, wherein no oxygen scavenging system is present within the growth compartment (no reactive oxygen species would be present in a closed system).
Regarding Claim 35, modified Hynes teaches the culture device of claim 2, wherein the oxygen sensitive luminophore is present in the culture medium (See Abstract. Method of detecting the presence of thermoduric microorganisms in a product that includes the steps of (i) placing an aliquot A of a product into a vessel 10 equipped with a probe 30 s. [0055] Nutrients can be added to the aliquot A prior to pasteurization for purposes of promoting growth of thermoduric microorganisms (or subsets thereof) in the aliquot A. Such nutrients, commonly referenced as culture media, are widely available from a number of sources.).
Regarding Claim 36, modified Hynes teaches the culture device of claim 1, further comprising one or more adhesive matrixes within the growth compartment and wherein the oxygen sensitive luminophore is dispersed within at least one of the one or more adhesive matrixes ([0044] The analyte-sensitive material is preferably a photoluminescent dye embedded within an analyte permeable polymer matrix. [0046] Typically, the hydrophobic oxygen-sensitive photoluminescent dye is compounded with a suitable oxygen-permeable and hydrophobic carrier matrix. The carrier matrix, indeed the entire probe 30, must be able to withstand the pasteurisation and incubation conditions. Again, one of routine skill in the art is capable of selecting a suitable oxygen-permeable hydrophobic carrier matrix based upon the intended use of the probe 30 and the selected dye. A nonexhaustive list of suitable polymers for use as the oxygen-permeable hydrophobic carrier matrix includes specifically, but not exclusively, polystyrene, polycarbonate, polysulfone, polyvinyl chloride and some co-polymers.).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Hynes (US 2014/147882; previously cited) and Lund (US Patent 5,443,963) as applied to claim 1 above, in view of Shen (US Pub 2018/0291330; previously cited).
Regarding Claim 24, Hynes teaches a culture device of claim 1.
Hynes is silent to the at least one of the oxygen impermeable barriers is a coverslip that is configurable between a first position where the coverslip is on the growth compartment and a second configuration wherein the coverslip is at least partially detached from the growth compartment.
Shen teaches in the related art of a culture device. In its assembled form, a DELRIN® base (white) holds a gas-impermeable glass coverslip with a cell monolayer to form the bottom diffusion barrier and the oxygen consumption layer; a polycarbonate pillar provides the other oxygen diffusion barrier as well as a transparent observation window for microscopy (FIG. 1E).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a coverslip that is configurable between a first position where the coverslip is on the growth compartment and a second configuration wherein the coverslip is at least partially detached from the growth compartment, as taught by Shen, to the culture device of Hynes, to allow for gas-impermeable layer, as taught by [0050].
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Hynes (US 2014/147882; previously cited), in view of Wilson (US Pub 2007/0166780; previously cited) and Lund (US Patent 5,443,963) as applied to claim 1 above, and in further view of Collman (“Oxygen Binding to Cobalt Porphyrins.” JACS. 100:9. 1978.; previously cited)
Regarding Claim 33, Hynes teaches the culture device of claim 1.
Hynes is silent to the oxygen-sensitive dye comprises leuco-form indigo dye, leuco-form thioindigo dye, one or more complexes of bis(histadino) cobolt, or meso-tetra(a-a-a-a-o-pivalminophenyl) porphyrinatocobolt.
Collman teaches The thermodynamic constants of oxygen binding to cobalt “picket fence” porphyrin complexes, meso-tetra(a,o,a,oo-pivalamidophenyl)porphyrinatocobalt(II)- 1 -methylimidazole and 1,2-dimethylimidazole, are reported. In contrast to previously studied cobalt porphyrins, these complexes bind oxygen with the same affinity as cobalt substituted myoglobin and hemoglobin.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have ultilized the oxygen sensitive dye, meso-tetra(a-a-a-a-o-pivalminophenyl) porphyrinatocobolt, as taught by Collman, in the culture device, of Hynes, to allow for binding of oxygen with a similar affinity to the biological molecules of myoglobin and hemoglobin, as taught by Collman, in the Abstract.
Response to Arguments
Applicant’s arguments, see page 7, filed 12/19/25, with respect to the claim objection have been fully considered and are persuasive. The objection of claim 28 has been withdrawn.
Applicant’s arguments, see pages 7-9, filed 12/19/25, with respect to the 112b rejection have been fully considered and are persuasive. The 112b rejection has been withdrawn.
Applicant's arguments, pages 10-14, filed 12/19/25 have been fully considered but they are not persuasive.
First, Applicant argues on page 10 that the prior art of Hynes does not teach or suggest a culture device comprising a culture medium wherein said culture medium is a thin film culture medium.
In response, the examiner notes an additional reference has been applied to the 103 rejection in light of the remarks regarding the definition of a “thin film culture medium”.
Conclusion
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798