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, 3, 4, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, and 25 are pending and are examined. Claims 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, and 39 are withdrawn and are not examined.
Claim Interpretation
The expression “low temperature” is deemed definite since the ordinary artisan would understand the meaning of “low temperature” in the light of the explicit explanation in applicant’s specification (see Spec., para [0051]-[0052]).
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, 11, 12, 13, 14, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nolli (EP 0192675), in view of Felix (US Pub 2009/0011925), as evidenced by Tennent (US Patent 4,892,857), which is incorporated by reference.
Regarding Claim 1, Nolli teaches a DNA synthesis substrate, the substrate comprising: a low temperature co-fired ceramic support (The solid phase carrier includes particles of cellulose, polyacrylamide, cross-linked dextrans, silicone rubber, microcrystalline glass and plastic and preferably preformed materials such as tubes, discs, or microplates moulded from plastic such as polystyrene, polypropylene and polyvinyl.); and
a linker molecule functionalized to the low temperature co-fired ceramic support (When the matrix used is a non-activated one, the coupling is preferably obtained by means of known activating agents such as cyanogen bromide, epichloridin, 1,4-bis-(2,3-diepoxypropoxy)butane and 3-aminopropyltriethoxysilane.).
Nolli is silent to the low temperature co-fired ceramic support comprises the low temperature co-fired ceramic support comprises: a mixture of Al2O3, forsterite, and borosilicate glass; a mixture of borosilicate glass, SiO2, and A12O3;a mixture of BaO, SiO2, and Al2O3;CaZrO3;a mixture of BaO, B2O3, Al2O3, CaO, and SiO2;a mixture of Nd2O3, TiO2, and SiO2;a mixture of PbO, Al2O3, and SiO2;a mixture of CaO, Al2O3, SiO2, B203, and Al2O3;a mixture of Al2O3, CaO, SiO2, ZrO2, MgO, B2O3; or a mixture of Al2O3, SiO2, ZrO2, and MgO.
Felix teaches in the related art of glass-ceramic materials. See Abstract. [0038] In accordance with one preferred embodiment of this invention, the glass-ceramic is an aluminosilicate having a composition comprising a range by weight of about 35-75% SiO2, 12-25% Al2O3, 5-30% of at least one of NiO, CoO, and FeO, 0-10% Li.sub.2O, 0-10% MgO, 0-5% CaO, 0-3% B.sub.2O.sub.3, 0-3% ZnO, 0-15% CeO2, and 0-5% of at least one of TiO2 and ZrO2. [0016] a method for creating a catalyst in which a mixture of materials--including glasses and glass-ceramics--are mixed with transition metal oxides and sintered together to form a monolithic article and reduced to form a material consisting of transition metals dispersed in a glass-ceramic.
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 mixture of Al2O3, as taught by Felix, to the ceramic support, and sintered together to form a monothilic article, as taught by Felix (as evidenced by Tennent), allowing for a catalytically active metal in a primary crystalline phase (aluminum), as taught by Felix, in [0038].
Regarding Claim 2, Nolli teaches the substrate of claim 1.
Nolli silent to the low temperature co-fired ceramic support is a monolithic structure.
Felix teaches in the related art of glass ceramic materials. See Abstract. In Claim 10, said fibers are formed into a monolithic catalytically active structure.
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 ceramic support, as taught by Nolli, to be a monolithic structure, to allow for a physically and chemically inert structure, as taught by Felix, in [0008].
Regarding Claim 11, Nolli teaches the substrate of claim 1, wherein the linker molecule comprises a silicon (When the matrix used is a non-activated one, the coupling is preferably obtained by means of known activating agents such as cyanogen bromide, epichloridin, 1,4-bis-(2,3-diepoxypropoxy)butane and 3-aminopropyltriethoxysilane.).
Regarding Claim 12, Nolli teaches the substrate of claim 11, wherein the linker molecule comprises a functionalized compound according to Formula I:R2 H3C
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136
73
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CH3 (I), wherein Rl is selected from the group consisting of a bond or (C1-C20)hydrocarbyl;R2 is selected from the group consisting of -OH and N(R3)2; and at each instance, R3 is independently selected from the group consisting of -H or (C1-C2o)hydrocarbyl (When the matrix used is a non-activated one, the coupling is preferably obtained by means of known activating agents such as cyanogen bromide, epichloridin, 1,4-bis-(2,3-diepoxypropoxy)butane and 3-aminopropyltriethoxysilane.).
Regarding Claim 13, Nolli teaches the substrate of claim 12, wherein R is selected from the group consisting of a bond or (C2-C7)hydrocarbyl ((When the matrix used is a non-activated one, the coupling is preferably obtained by means of known activating agents such as cyanogen bromide, epichloridin, 1,4-bis-(2,3-diepoxypropoxy)butane and 3-aminopropyltriethoxysilane.).
Regarding Claim 14, Nolli teaches the substrate of claim 12, wherein R' is selected from the group consisting of a bond or (C2-C2a)alkenyl, (C2-C2a)aryl, (C2-C2o)hydroxyl, (C2-C2a)alkyl, or (C2-C2a)cycloalkyl (When the matrix used is a non-activated one, the coupling is preferably obtained by means of known activating agents such as cyanogen bromide, epichloridin, 1,4-bis-(2,3-diepoxypropoxy)butane and 3-aminopropyltriethoxysilane.).
Regarding Claim 15, Nolli teaches the substrate of claim 1, wherein the linker molecule comprises a 3- aminopropyltriethoxysilane, a trimethylsilanol, or both (When the matrix used is a non-activated one, the coupling is preferably obtained by means of known activating agents such as cyanogen bromide, epichloridin, 1,4-bis-(2,3-diepoxypropoxy)butane and 3-aminopropyltriethoxysilane.).
Regarding Claim 16, Nolli teaches the substrate of claim 1.
Nolli is silent to the substrate comprises at least two different linker molecules.
Felix teaches different kinds of linkers. When the matrix used is a non-activated one, the coupling is preferably obtained by means of known activating agents such as cyanogen bromide, epichloridin, 1,4-bis-(2,3-diepoxypropoxy)butane and 3-aminopropyltriethoxysilane.
While Felix does not teach using two different linker molecules on the same substrate, 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 to different kinds of coupling agents, as taught by Felix, to the substrate, as taught by Nolli, to allow for different chemicals or biomolecules to bind to the same substrate and measure these simultaneously.
Claims 7, 8, 9, 17, 18, 19, 20, 21, 22, 23, 24, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Nolli (EP 0192675), in view of Blackburn (US Pub 2003/0190608).
Regarding Claim 7, Nolli teaches the substrate of claim 1.
Nolli is silent to a surface of the ceramic support is functionalized.
Blackburn teaches [0051] In an additional aspect, the invention provides microfluidic devices comprising a ceramic substrate comprising at least one biochannel comprising a plurality of spatially distinct regions upon which capture binding ligands are immobilized. [0055] FIG. 3 shows microfluidic channels with molded plastic microstructures for DNA attachment. FIG. 3 illustrates a microfluidic channel 15 where high surface area microstructures are molded into the channel. FIG. 3a shows a series of columns 16 in a distinct region and FIG. 3b shows a distinct region of domes 17 molded into channel 15. These microstructures are chemically modified and specific binding substances are attached.
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 functionalized, as taught by Blackburn, the ceramic support in the device of Nolli to perform PCR in the device.
Regarding Claim 8, Nolli teaches the substrate of claim 7.
Nolli is silent to about 50% to about 100% surface area of the surface is functionalized.
Blackburn teaches in the related art of glass-ceramic materials. [0055] FIG. 3 shows microfluidic channels with molded plastic microstructures for DNA attachment. FIG. 3 illustrates a microfluidic channel 15 where high surface area microstructures are molded into the channel. FIG. 3a shows a series of columns 16 in a distinct region and FIG. 3b shows a distinct region of domes 17 molded into channel 15. These microstructures are chemically modified and specific binding substances are attached.
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 functionalized 100% of a surface, as taught by Blackburn, the ceramic support in the device of Nolli to perform PCR in the device.
Regarding Claim 9, Nolli teaches the substrate of claim 7.
Nolli is silent to about 75% to about 90% surface area of the surface is functionalized.
Blackburn teaches in the related art of glass-ceramic materials. [0055] FIG. 3 shows microfluidic channels with molded plastic microstructures for DNA attachment. FIG. 3 illustrates a microfluidic channel 15 where high surface area microstructures are molded into the channel. FIG. 3a shows a series of columns 16 in a distinct region and FIG. 3b shows a distinct region of domes 17 molded into channel 15. These microstructures are chemically modified and specific binding substances are attached.
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 functionalized 90%, as taught by Blackburn, the ceramic support in the device of Nolli to perform PCR in the device.
Regarding Claim 17, Nolli teaches the substrate of claim 1.
Blackburn is silent to an oligonucleotide bonded to the linker molecule.
Felix teaches [0005] To enhance immobilization of probe molecules, biochips can include a 2-dimensional array of 3-dimensional polymeric anchoring structures (for example, polyacrylamide gel pads) attached to the surface of the substrate. Probe molecules such as oligonucleotides are covalently attached to polyacrylamide-anchoring structures by forming amide, ester or disulfide bonds between the biomolecule and a derivatized polymer comprising the cognate chemical group. Covalent attachment of probe molecules to such polymeric anchoring structures is usually performed after polymerization and chemical cross-linking of the polymer to the substrate is completed.
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 bonded the oligonucleotide of Blackburn to the linker molecule on the ceramic support, as taught by Nolli, to allow for direct attachment.
Regarding Claim 18, modified Nolli teaches the substrate of claim 17, wherein the oligonucleotide comprises a single stranded DNA ([0107] As outlined herein, the nucleic acids may be single stranded or double stranded, as specified, or contain portions of both double stranded or single stranded sequence. The nucleic acid may be DNA, both genomic and cDNA, RNA or a hybrid, where the nucleic acid contains any combination of deoxyribo- and ribo-nucleotides).
Regarding Claim 19, modified Nolli teaches the substrate of claim 17, wherein the oligonucleotide comprises 2 to 300 nucleotides ([0108] The target sequence may be a portion of a gene, a regulatory sequence, genomic DNA, cDNA, RNA including mRNA and rRNA, or others. It may be any length, with the understanding that longer sequences are more specific. In some embodiments, it may be desirable to fragment or cleave the sample nucleic acid into fragments of 100 to 10,000 basepairs, with fragments of roughly 500 basepairs being preferred in some embodiments.).
Regarding Claim 20, Nolli teaches the substrate of claim 1.
Nolli is silent to a DNA synthesis device comprising: a reaction chamber; and the substrate located at least partially within the reaction chamber.
Blackburn teaches [0024] Thus, there is a significant trend to reduce the size of these sensors, both for sensitivity and to reduce reagent costs. Thus, a number of microfluidic devices have been developed, generally comprising a solid support with microchannels, utilizing a number of different wells, pumps, reaction chambers, and the like. [0100] In a preferred embodiment, the substrates comprising biochannels can be configured to contain reaction chambers including the biochannels, wherein the reaction chamber is formed with a substrate, a layer of adhesive and a flexible cover.
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 reaction chamber, as taught by Blackburn, and arranging the substrate of Nolli in the reaction chamber as taught by Blackburn, to utilize a chamber for sample and reagent loading onto a substrate and avoid reagent spillage.
Regarding Claim 21, modified Nolli teaches the device of claim 20, further comprising: a second reaction chamber; and a second substrate of claim 1, located at least partially within the second reaction chamber ([0024] Thus, there is a significant trend to reduce the size of these sensors, both for sensitivity and to reduce reagent costs. Thus, a number of microfluidic devices have been developed, generally comprising a solid support with microchannels, utilizing a number of different wells, pumps, reaction chambers, and the like.).
Regarding Claim 22, modified Nolli teaches the device of claim 21, wherein the reaction chamber and the second reaction chamber are independently a well, a channel, a cartridge, a pore or a reaction site ([0024] Thus, there is a significant trend to reduce the size of these sensors, both for sensitivity and to reduce reagent costs. Thus, a number of microfluidic devices have been developed, generally comprising a solid support with microchannels, utilizing a number of different wells, pumps, reaction chambers, and the like.).
Regarding Claim 23, modified Nolli teaches the device of claim 20, wherein the device is a microdevice or a nanodevice ([0001] The invention pertains to the structure, fabrication of a microfluidic device and methods for conducting analysis in microfluidic devices. Device with microchannels would be a microdevice.).
Regarding Claim 24, modified Nolli teaches the device of claim 20, wherein the device is a microarray or a DNA synthesizer ([0157] The invention is advantageously used for performing assays using biochips 18. Biochips, as used in the art, encompass substrates containing arrays or microarrays).
Regarding Claim 25, modified Nolli teaches The device of claim 20, wherein the device is an automated device ([0295] any or all of the steps outlined herein may be automated; thus, for example, the systems may be completely or partially automated.).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Nolli (EP 0192675), in view of Blackburn (US Pub 2003/0190608), and further in view of Banyal (US Pub 2015/0038373).
Regarding Claim 10, modified Nolli teaches the substrate of claim 7.
Modified Nolli is silent to the surface is functionalized with hydroxyl groups.
Banyal teaches in the related art of nucleic acids. [0332] FIG. 5 illustrates a case when a droplet of reagent is deposited into a microwell by an inkjet printer. The liquid droplet can spread over and fill the smaller microwells because the surface of the microwells has higher surface energy compared to the other surface nearby in this case. The reactive hydrophilic moieties on the substrate surface can be hydroxyl groups, carboxyl groups, thiol groups, and/or substituted or unsubstituted amino groups.
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 functionalized the substrate, as taught by Nolli, with hydroxyl groups, as taught by Banyal, to allow for a hydrophilic surface, as taught by Banyal in [0332].
Response to Arguments
Applicant's arguments filed 5/11/26 have been fully considered but they are not persuasive.
Applicant argues on pages 8-9 that the prior art of Nolli is silent to any low temperature co-fired ceramic material. On page 9, the prior art of Felix is directed to catalytically active glass-ceramics.
In response, the examiner notes that the prior art of Felix (as evidenced by Tennent) teaches in [0016] a method for creating a catalyst in which a mixture of materials--including glasses and glass-ceramics--are mixed with transition metal oxides and sintered together to form a monolithic article and reduced to form a material consisting of transition metals dispersed in a glass-ceramic.
The examiner further notes that although the claims are directed to a DNA synthesis substrate, there is no limitation that requires DNA synthesis on the claimed substrate, and therefore, the substrate can be used for other intended uses besides DNA synthesis. Therefore, the rejection is maintained.
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 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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