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 .
Claim Status
Claims 1, 2, and 24-36 are pending and are examined. Claims 37-40 are withdrawn and are not examined.
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, 34, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Brutinel (US Pub 20180100131), in view Erickson (US Pub 2019/0276868).
Regarding Claim 1, Brutinel teaches a culture device (A device for culturing anaerobic microorganisms. See Abstract.) comprising a growth compartment surrounded by one or more oxygen impermeable barriers, at least one of the oxygen impermeable barriers being configurable between an open configuration (Because anaerobic microorganisms do not thrive in the presence of oxygen, cumbersome physical and chemical techniques can be required to grow such organisms. Typically, such devices must be modified, i.e., shaped or configured, to provide a physical barrier to the transmission of oxygen. [0005] Other techniques have been developed that use chemical agents incorporated into an anaerobic culturing device to remove oxygen. Generally, such devices include a reducing agent or sterile membrane fragments of bacteria incorporated into a gel or nutrient media. In addition, U.S. Pat. No. 3,338,794 describes an anaerobic bacteria culturing device formed of oxygen impermeable film layers)
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 ([0094] The base is positioned adjacent the cover sheet such that at least a portion of the adhered gelling agent faces the growth compartment disposed between the base and the coversheet.);
a culture medium disposed within the growth compartment, and is capable of supporting replication of at least one microorganism disposed within the growth compartment ([0003] a suitable medium for growth of the microorganism, such as agar and nutrients. The use of agar medium); and
an oxygen-sensitive dye disposed within the growth compartment wherein said culture medium is a thin film culture medium ([0075] Optionally, a culture device of the present disclosure further comprises a means for indicating oxygen in a culture device. Means for detecting oxygen in a culture device are known in the art and include, for example, redox dyes (e.g., methylene blue) and oxygen-quenched fluorescent dyes. [0076] The means can be a luminescent compound that indicates the absence of oxygen inside of the device.).
Brutinel is silent to wherein said culture medium is a thin film culture medium.
Erickson teaches [0090] A variety of solid supports may be used. In certain embodiments, the solid support may comprise a multi-well plate, a filter, a bead, a lateral flow strip, a filter strip, filter disc, filter paper, or thin films designed for culturing cells (e.g., Petrifilm by 3M).
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, as taught by Brutinel, to be Petrifilm (thin film culture medium), as taught by Erickson, to allow for culturing cells, as taught by Erickson, in [0090].
Regarding Claim 2, modified Brutinel teaches the culture device of claim 1, wherein the oxygen sensitive dye comprises an oxygen sensitive luminophore ([0075] Optionally, a culture device of the present disclosure further comprises a means for indicating oxygen in a culture device. [0075] Means for detecting oxygen in a culture device are known in the art and include, for example, redox dyes (e.g., methylene blue) and oxygen-quenched fluorescent dyes.).
Regarding Claim 25, modified Brutinel teaches the culture device of claim 1, wherein the culture medium comprises agar or a water-gelling thin film ([0003] a suitable medium for growth of the microorganism, such as agar and nutrients. The use of agar medium).
Regarding Claim 26, 27, 28, and 29, modified Brutinel 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 ([0076] Suitable compounds for indicating oxygen include metallo derivatives of octaethylporphyrin, tetraphenylporphyrin, tetrabenzoporphyrin, the chlorins, or bacteriochlorins. Other suitable compounds include palladium coproporphyrin (PdCPP), platinum and palladium octaethylporphyrin (PtOEP, PdOEP), platinum and palladium tetraphenylporphyrin (PtTPP, PdTPP), camphorquinone (CQ), and xanthene type dyes such as erythrosin B (EB). Other suitable compounds include ruthenium, osmium and iridium complexes with ligands such as 2,2′-bipyridine, 1,10-phenanthroline, 4,7-diphenyl-1,10-phenanthroline and the like. Suitable examples of these include, tris(4,7,-diphenyl-1,10-phenanthroline)ruthenium(II) perchlorate, tris(2,2′-bipyridine)ruthenium(II) perchlorate, tris(1,10-phenanthroline)ruthenium(II) perchlorate, and the like.)
Regarding Claim 30, modified Brutinel 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 ([0076] Suitable compounds for indicating oxygen include metallo derivatives of octaethylporphyrin, tetraphenylporphyrin, tetrabenzoporphyrin, the chlorins, or bacteriochlorins. Other suitable compounds include palladium coproporphyrin (PdCPP), platinum and palladium octaethylporphyrin (PtOEP, PdOEP), platinum and palladium tetraphenylporphyrin (PtTPP, PdTPP), camphorquinone (CQ), and xanthene type dyes such as erythrosin B (EB). Other suitable compounds include ruthenium, osmium and iridium complexes with ligands such as 2,2′-bipyridine, 1,10-phenanthroline, 4,7-diphenyl-1,10-phenanthroline and the like. Suitable examples of these include, tris(4,7,-diphenyl-1,10-phenanthroline)ruthenium(II) perchlorate, tris(2,2′-bipyridine)ruthenium(II) perchlorate, tris(1,10-phenanthroline)ruthenium(II) perchlorate, and the like.
Regarding Claim 31, modified Brutinel teaches the culture device of claim 29, wherein the pi-conjugated molecule comprises a porphyrin ([0076] Suitable compounds for indicating oxygen include metallo derivatives of octaethylporphyrin, tetraphenylporphyrin, tetrabenzoporphyrin, the chlorins, or bacteriochlorins. Other suitable compounds include palladium coproporphyrin (PdCPP), platinum and palladium octaethylporphyrin (PtOEP, PdOEP), platinum and palladium tetraphenylporphyrin (PtTPP, PdTPP), camphorquinone (CQ), and xanthene type dyes such as erythrosin B (EB). Other suitable compounds include ruthenium, osmium and iridium complexes with ligands such as 2,2′-bipyridine, 1,10-phenanthroline, 4,7-diphenyl-1,10-phenanthroline and the like. Suitable examples of these include, tris(4,7,-diphenyl-1,10-phenanthroline)ruthenium(II) perchlorate, tris(2,2′-bipyridine)ruthenium(II) perchlorate, tris(1,10-phenanthroline)ruthenium(II) perchlorate, and the like.)
Regarding Claim 34, modified Brutinel 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 Brutinel teaches the culture device of claim 2, wherein the oxygen sensitive luminophore is present in the culture medium ([0076] Suitable compounds for indicating oxygen include metallo derivatives of octaethylporphyrin, tetraphenylporphyrin, tetrabenzoporphyrin, the chlorins, or bacteriochlorins. Other suitable compounds include palladium coproporphyrin (PdCPP), platinum and palladium octaethylporphyrin (PtOEP, PdOEP), platinum and palladium tetraphenylporphyrin (PtTPP, PdTPP), camphorquinone (CQ), and xanthene type dyes such as erythrosin B (EB). Other suitable compounds include ruthenium, osmium and iridium complexes with ligands such as 2,2′-bipyridine, 1,10-phenanthroline, 4,7-diphenyl-1,10-phenanthroline and the like. Suitable examples of these include, tris(4,7,-diphenyl-1,10-phenanthroline)ruthenium(II) perchlorate, tris(2,2′-bipyridine)ruthenium(II) perchlorate, tris(1,10-phenanthroline)ruthenium(II) perchlorate, and the like.)
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Brutinel (US Pub 20180100131), in view Erickson (US Pub 2019/0276868), as applied to claim 1 above, in view of Shen (US Pub 2018/0291330; previously cited).
Regarding Claim 24, Brutinel 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 Brutinel, to allow for gas-impermeable layer, as taught by [0050].
Claim 32 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Brutinel (US Pub 20180100131), in view Erickson (US Pub 2019/0276868), as applied to claim 1 above, and in further view of Hynes (US Pub 2014/0147882; previously cited).
Regarding Claim 32, modified Brutinel teaches the culture device of claim 2.
Modified Brutinel is silent to wherein the oxygen sensitive luminophore is Pd-meso-tetra-(4-carboxypenyl)porphyrin dendrimer.
Hynes teaches detecting microorganisms in the Abstract. [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).
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 Pd-meso-tetra-(4-carboxypenyl)porphyrin dendrimer, as taught by Hynes, as the oxygen sensitive luminophore, in the device of modified Brutinel, for using a well-known oxygen sensitive photoluminescent dyes, as taught by Hynes, in [0045].
Regarding Claim 36, modified Brutinel teaches the culture device of claim 1.
Modified Brutinel is silent to 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.
Hynes teaches [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.
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 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, as taught by Hynes, in the device of modified Brutinel, to allow for sensitive material configured and arranged to experience changes in target-analyte concentration, as taught by Hynes, in [0044].
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Brutinel (US Pub 20180100131), in view Erickson (US Pub 2019/0276868), 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, Brutinel teaches the culture device of claim 1.
Brutinel 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 Brutinel, 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, filed on 4/21/26, with respect to the 1-3 rejection been considered but are moot because the new ground of rejection relies on a new reference.
First, Applicant argues that claim 1 is not taught by the prior art and the culture medium is a thin film medium.
In response, the examiner notes new references are cited over amended independent claim 1. A Petrifilm or agar, as taught by the cited prior art, would meet the limitation “the culture medium is a thin film medium” and is commonly found in a petri dish.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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