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 Objections
Claim 1 objected to because of the following informalities: The claim recites “upper surface of the second layer” and should be amended to recite “an upper surface of the second layer”. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Such claim limitation(s) is/are:
“a thermal control device that regulates the temperature of the imaging zone” in Claim 13.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
“heaters/coolers” as in para. [0032] of Applicant’s instant pre-grant publication US20230111586A1,...and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
Claims 1-18 are 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.
Claims 1 and 15 recite the limitation "the layer". There is insufficient antecedent basis for this limitation in the claim. It is unclear to which of the two layers “the layer” refers to.
Similarly, the claims recite “the top face”, “the lower portion of the top layer”, “the upper layer”, “the second layer”, “the lower surface of Layer 2”, “the upper surface”. There is insufficient antecedent basis for these limitations in the claim.
Regarding Claim 3, the claim recites “wherein the microfluidic channels are constricted” which is interpreted as a process-type recitation. Applicant may wish to amend the claim to recite on the order of “wherein the microfluidic channels comprise constricted portions”.
Claim 5 recites the limitation “each column of wells”. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation “the temperature of the imaging zone”. There is insufficient antecedent basis for this limitation in the claim.
Claims 14 and 16 recite the limitation “the group consisting of”. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites “a capture probe that stably binds the analyte; a query probe that transiently binds to the analyte; and a microfluidic microplate, according to claim 1 that comprises a substrate and a capture area in which the capture probe is immobilized”. Therein, the arrangement of the capture probe within the system is understood given its attachment to the substrate. However, the substrate and the query probe are recited in isolation, wherein these two elements lack a functional or structural recitation designating their position within the system. As such, the substrate and the query probe are indefinitely arranged within the microplate of Claim 1.
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.
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 1-3, 5-6, 12, 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Choi et al. (Charles Choi and Brian Cunningham; “A 96-well microplate incorporating a replica molded microfluidic network integrated with photonic crystal biosensors for high throughput kinetic biomolecular interaction analysis”, Lab Chip, 2007,7, 550-556.), hereinafter “Choi”, in view of Fang (Te Fang, “Total internal reflection fluorescence quantification of receptor pharmacology”, Biosensors (Basel). 2015 Apr 27; 5(2): 223-40.), hereinafter “Fang”, and as evidenced through Ockenga et al. (Wymke Ockenga and Thomas Veitinger, “Applications of TIRF Microscopy in Life Science Research”, March 11, 2012, Leica Microsystems Blog Post.), hereinafter “Ockenga”.).
Regarding Claim 1, Choi teaches a microfluidic microplate comprising two or three layers, said microfluidic microplate comprising:
b) a two-layer microfluidic microplate comprising a top layer (Layer 1) that comprises a plurality of wells on the top face of the layer (Fig. 1 shows “individual wells”. – Further, Choi discusses layers of the device in the “Materials and methods” section.),
each well having an opening that is fluidly connected to microfluidic channels that are integrated into the lower portion of the top layer or the upper layer or upper surface of the second layer (Layer 2) (Fig. 1 shows “inlet/outlet holes” of each of the individual wells, which are connected to microfluidic channels of the “microfluidic network” as shown. Examiner further notes that mere change in orientation or position of elements absent any criticality or unexpected result is an obvious matter of design choice – see MPEP 2144.04(VI)(C). Thus, the integration of the microfluidic channels as “integrated into the lower portion of the top layer or the upper layer or upper surface of the second layer” would be seen as an obvious matter of design choice by one having ordinary skill in the art),
wherein the upper layer comprises a planar surface comprising imaging zones (Figs. 1 and 3-4 show imaging of the common well/imaging zone. – Examiner further notes that as currently claimed, the imaging “zone” is merely a nominal region of space which could be arbitrarily defined by one having ordinary skill in the art, given that no structure is appended thereto. Applicant may wish to recite an imaging well or an imaging chamber instead.),
and an exit port that is provided in Layer 1 (Fig. 1: The “common outlet”.)
as in Claim 1.
Further regarding Claim 1, Choi does not specifically teach the microwell plate discussed above further comprising a high refractive index material as a waveguide for waveguide total internal reflection fluorescence (TIRF) microscopy, as in Claim 1.
However, TIRF microscopy is well-known in the art and has been applied to numerous microwell plates.
Herein, Fang teaches a microplate-based TIRF imaging system utilizing a high refractive index material (glass and prism) so as to provide the structure capable of total internal reflection, thereby enabling TIRF (Fig. 2). Further, TIRF microscopy is known in the art to offer a high signal-to-noise ratio, reduced background, and sharper images therethrough, as evidenced through Ockenga.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi so as to include a high refractive index material as a waveguide for waveguide total internal reflection fluorescence (TIRF) microscopy, such as suggested by Fang, so as to achieve a high signal-to-noise ratio, reduced background, and sharper images therethrough, as evidenced through Ockenga; and would have a reasonable expectation of success therein.
Examiner further notes that Claim 1 is provided as an alternative “or”-type recitation. Thus, as a) and c) are not required by the claim, examiner has only mapped the prior art to option b). This is further seen in other recitations of Claim 1, such as “integrated into the lower portion of the top layer OR the upper layer OR upper surface of the second layer” wherein the Claim only requires that one of these alternatives be present in the prior art, and is also seen in some of the dependent claims.
Regarding Claim 2, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi teaches the microwell plate discussed above wherein the microfluidic channels converge on the imaging zone from two (2), three (3), four (4), five (5), six (6), seven (7), eight (8), OR more wells (Fig. 1 shows the microfluidic channels converging on the common well from at least six wells as shown in the figure.), as in Claim 2.
Regarding Claim 3, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi teaches the microwell plate discussed above wherein the microfluidic channels are constricted (Fig. 1 shows the microchannels of the microfluidic network as being constricted when they branch into sub-channels. Constrict: “to make narrower” – Oxford English Dictionary.), as in Claim 3.
Regarding Claim 5, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi teaches the microwell plate discussed above wherein the microfluidic channels connecting each column of wells to an imaging zone have equal length (Fig. 1 and [Introduction]: “Serpentine flow channel patterns are used to ensure an equal length flow path from each analyte well to the common well.”), as in Claim 5.
Regarding Claim 6, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi teaches the microwell plate discussed above wherein the microfluidic channels are serpentine (Fig. 1 and [Introduction]: “Serpentine flow channel patterns are used to ensure an equal length flow path from each analyte well to the common well.”), as in Claim 6.
Regarding Claim 12, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi teaches the microwell plate discussed above wherein the imaging zones are aligned linearly (Fig. 3), as in Claim 12.
Regarding Claim 14, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi does not specifically teach the microwell plate discussed above wherein the microfluidic microplate comprises a prism, said prism comprising a material selected from the group consisting of a glass, borosilicate glass, fused silica, silicon nitride, tantalum pentoxide, plastic, and combinations thereof, said material having a refractive index of about 1.5, at least 1.5, or about 1.5 and about 1.9, as in Claim 14.
However, Fang teaches a respective microwell plate comprising a glass prism for the enablement of TIRF microscopy, as discussed above regarding Claim 1, wherein said prism has a refractive index of about 1.5 ([2. Evanescent Wave]: “For typical TIRF setup, the glass of a cover slip has a RI of 1.515”). Therein, this arrangement and refractive index is common in TIRF microscopy, the benefits of which being discussed above regarding Claim 1.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi so as to include a prism, said prism comprising a glass material, said material having a refractive index of about 1.5, such as suggested by Fang, so as to provide a sufficient structure for performing TIRF microscopy as discussed above regarding the Combination of Choi and Fang in Claim 1; and would have a reasonable expectation of success therein.
Regarding Claim 15, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi teaches the microwell plate discussed above further comprising a two layer microfluidic microplate comprising a top layer (Layer 1) that comprises a plurality of wells on the top face of the layer (Fig. 1 shows “individual wells”.),
each well having an opening that is fluidly connected to microfluidic channels that are integrated into the upper layer (Fig. 1 shows “inlet holes” of each of the individual wells, which are connected to microchannels, “microfluidic network”.)
that comprises a planar surface comprising imaging zones (Figs. 1 and 3-4 show imaging of the common well/imaging zone. – Examiner further notes that as currently claimed, the imaging “zone” is merely a nominal region of space which could be arbitrarily defined by one having ordinary skill in the art, given that no structure is appended thereto. Applicant may wish to recite an imaging well or an imaging chamber instead.),
and an exit port that is provided in Layer 1 and/or Layer 2 (Fig. 1: The “common outlet”.),
as in Claim 15.
Further regarding Claim 15, Choi does not specifically teach the microwell plate discussed above further comprising a high refractive index material as a waveguide for waveguide total internal reflection fluorescence (TIRF) microscopy, the imaging zones being deposited on the high refractive index material, as in Claim 15.
However, TIRF microscopy is well-known in the art and has been applied to numerous microwell plates. Herein, Fang teaches a microplate-based TIRF imaging system utilizing a high refractive index material (glass and prism) so as to provide the structure capable of total internal reflection, thereby enabling TIRF (Fig. 2). Further, TIRF microscopy is known in the art to offer a high signal-to-noise ratio, reduced background, and sharper images therethrough, as evidenced through Ockenga. Further, Fig. 2a shows the imaging wells as being deposited on the high refractive index material, wherein this close association is well-known in the art of TIRF microscopy as being necessary to allow light being reflected within the prism/waveguide to interact with the sample positioned above.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi so as to include a high refractive index material as a waveguide for waveguide total internal reflection fluorescence (TIRF) microscopy, such as suggested by Fang, so as to achieve a high signal-to-noise ratio, reduced background, and sharper images therethrough, as evidenced through Ockenga, and wherein the imaging zone is deposited on the high refractive index material, wherein this close association is well-known in the art of TIRF microscopy as being necessary to allow light being reflected within the prism/waveguide to interact with the sample positioned above; and would have a reasonable expectation of success therein.
Regarding Claim 16, the prior art meets the limitations of Claim 15 as discussed above. Further, Choi does not specifically teach the microwell plate discussed above wherein the microfluidic microplate comprises a prism, said prism comprising a material selected from the group consisting of a glass, borosilicate glass, fused silica, silicon nitride, tantalum pentoxide, plastic, and combinations thereof, said material having a refractive index of about 1.5, at least 1.5, or about 1.5 and about 1.9, as in Claim 16.
However, Fang teaches a respective microwell plate comprising a glass prism for the enablement of TIRF microscopy, as discussed above regarding Claim 1, wherein said prism has a refractive index of about 1.5 ([2. Evanescent Wave]: “For typical TIRF setup, the glass of a cover slip has a RI of 1.515”). Therein, this arrangement and refractive index is common in TIRF microscopy, the benefits of which being discussed above regarding Claim 1.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi so as to include a prism, said prism comprising a glass material, said material having a refractive index of about 1.5, such as suggested by Fang, so as to provide a sufficient structure for performing TIRF microscopy as discussed above regarding the Combination of Choi and Fang in Claim 1; and would have a reasonable expectation of success therein.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Fang, as applied to Claims 1-3, 5-6, 12, 14-16 above, and in further view of Meathrel et al. (US 2004/0115831 A1), hereinafter “Meathrel”.
Regarding Claim 4, the prior art meets the limitations of Claim 3 as discussed above. Further, Choi/Fang does not specifically teach the microwell plate discussed above wherein the microfluidic channels are treated with: a) a hydrophobic material selected from polytetrafluoroethylene (PTFE), fluorinated ethylene propylene (FEP), silanes comprising one or more hydrocarbon group, perfluoroalkoxy (PFA), or combinations thereof; or b) a hydrophilic material selected from polyethylene glycol (PEG), polyacrylamide, poly(vinyl alcohol) (PVA), hydroxylethylcellulose (HEC), poly(N-hydroxyethyl acrylamide) (PHEA), hydroxylpropyl methylcellulose (HPMC), poly(2-hydroxyethyl methacrylate) (pHEMA), poly(vinyl pyrrolidone) (PVP), poly(acrylic acid) (PAA), dextran, hyaluronic acid, poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC), or combinations thereof, as in Claim 4.
However, the use of hydrophobic and hydrophilic coatings for channel interiors of microfluidic devices is well-known in the art for influencing and controlling flow dynamics within the device. Herein, Meathrel discusses the use of hydrophilic coatings disposed on the interior surfaces of microfluidic channels to enhance flow of biological material through such microfluidic devices ([0056]), wherein Meathrel specifically teaches PEG as a suitable coating material for achieving this enhanced flow effect ([0058]).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi/Fang such that the microfluidic channels are treated with a hydrophilic material polyethylene glycol (PEG), such as suggested by Meathrel so as to enhance and promote the flow of aqueous biological material through the device, thereby reducing error due to improper flow; and would have a reasonable expectation of success therein.
Claims 7-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Fang, as applied to Claims 1-3, 5-6, 12, 14-16 above, and in further view of Panchapakesan et al. (US 2018/0088117 A1), hereinafter “Panchapakesan”.
Regarding Claim 7, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi/Fang does not specifically teach the microwell plate discussed above wherein the imaging zones are functionalized with: a) a functionalization agent comprising a carboxyl, amine, thiol, or hydroxyl functional group; b) a self-assembling functional agent selected from n-octadecyltrichlorosilane, 11- bromo undecyltri chi orosilane, 1H,1H,2H,2H-perfluoro-decyltrichlorosilane, N-[3- (trimethoxysilyl)propyl ]-ethylenediamine, (3-aminopropyl)trimethoxy-silane, (3- aminopropyl)triethoxysilane, (3 -mercaptpropyl)trimethoxysilane, PEG silanes (having a trichlorosiloxane, trimethoxysiloxane, or triethoxysiloxane functional group), N-(6- aminohexyl)-3-aminopropyltrimethoxysilane, phenyltrichlorosilane, benzyltrichlorosilane, n- octadecyltrimethoxysilane, heptadecafluoro-1,1,2,2-tetrahydro-decyl-1-trimethoxy-silane, 3,3,3-trifluoropropyltrimethoxysilane, (4-chloromethyl)phenyltrimethoxysilane, 18- nonadecenyltrichlorosilane, 2,2,2-trifluoroethyl undec-10-enoate and combinations thereof,c) a functionalization agent comprising a silane group that binds to a surface of the imaging zone and a free hydroxyl group, thiol group, mercapto groups, carboxyl group, or amine group; d) a functionalization agent selected from N-(3-triethoxysilylpropyl)-4- hydroxybutyramide (HAPS), 11-acetoxyundecyltriethoxysilane, n-decyltriethoxysilane, (3- aminopropyl)trimethoxysilane, (3 -aminopropyl)triethoxysilane, 3- glycidoxypropyltrimethoxysilane (GOPS), 3-iodo-propyltrimethoxysilane, butyl-aldehydr- trimethoxysilane; dimeric secondary aminoalkyl siloxanes; aminosilanes such as (3- aminopropyl)-triethoxysilane, (3-aminopropyl)-diethoxy-methylsilane, (3-aminopropyl)- dimethyl-ethoxysilane, (3-aminopropyl)-trimethoxysilane, glycidoxysilanes, (3- glycidoxypropyl)-dimethyl-ethoxysilane glycidoxy-trimethoxysilane, mercaptosilanes, (3- mercaptopropyl)-trimethoxysilane, 3-4 epoxycyclohexyl-ethyltrimethoxysilane, (3- mercaptopropyl)-methyl-dimethoxysilane, siloxanes, hydroxyalkyl siloxanes, and combinations thereof; and/or e) a binding agent binding an analyte selected from antibodies, aptamer, nucleic acid sequences, enzymes, hormones, interleukins, chemokines, growth regulators, clotting factors, phosphoproteins, immunogens, polysaccharides, toxins, cell walls, cell capsules, viral capsules, viral coats, flagellae, fimbriae, pili, microorganisms, lipids, molecules associated with, or present in, bodily fluids from mammals, or combinations thereof, as in Claim 7.
However, Panchapakesan teaches a respective microarray device wherein a detection/imaging zone is functionalized with “one or more agents 14 selected for capturing the desired target. In some embodiments, the nanotubes may be functionalized with anti-epithelial-cell-adhesion-molecule (EpCAM), anti-human epithelial growth factor receptor 2 (anti-Her2) and nonspecific immunoglobin (IgG) antibodies, PSMA, EGFR, her2-neu, her1, her3, G-protein coupled receptors and combinations thereof. In some embodiments, the surface of the CNT film 12 may be functionalized with EpCAM and anti-Her2, by themselves or in combination with other capture agents.” ([0055]) It is noted that Panchapakesan teaches IgG, an antibody, and epidermal growth factor receptor (EGFR) protein, which is a growth regulator, commensurately as claimed. Therein, these agents act as probes for detecting target molecules, which is well-known in the art of biochemical detection.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi/Fang so as to include a binding agent such as IgG or EGFR, such as suggested by Panchapakesan, so as to enable biochemical detection via binding interactions, a well-known technique used throughout the biological sciences; and would have a reasonable expectation of success therein.
Regarding Claim 8, the prior art meets the limitations of Claim 7 as discussed above. Further, as discussed above regarding Claim 7, while Choi/Fang does not specifically teach binding agents, Panchapakesan remedies this deficiency.
Thus, as discussed above regarding Claim 7, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi/Fang so as to include a binding agent such as IgG or EGFR, such as suggested by Panchapakesan, so as to enable biochemical detection via binding interactions, a well-known technique used throughout the biological sciences; and would have a reasonable expectation of success therein.
Regarding Claim 9, the prior art meets the limitations of Claim 8 as discussed above. Further, as discussed above regarding Claim 7, while Choi/Fang does not specifically teach binding agents, Panchapakesan remedies this deficiency. Additionally, Panchapakesan specifically teaches the use of combinations of binding agents in the device ([0055]: “…by themselves or in combination with other capture agents.”). As such, Panchapakesan teaches the use of two or more of the agents discussed above regarding Claims 7 and 8. Further, this assembly using multiple capture agents provides for a more redundant detection system, wherein the system does not rely on a single agent for detection and thus allows for fewer points of failure, thereby reducing error related thereto, as would be understood by one of ordinary skill in the art. -- The rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law – see MPEP 2144(I).
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the microwell plate of Choi/Fang so as to utilize two or more of the above mentioned detection agents, such as suggested by Panchapakesan, so as to provide for a more redundant detection system, wherein the system does not rely on a single agent for detection and thus allows for fewer points of failure, thereby reducing error related thereto, as would be understood by one of ordinary skill in the art; and would have a reasonable expectation of success therein.
Regarding Claim 11, the prior art meets the limitations of Claim 9 as discussed above. Further, Choi/Fang does not specifically teach the microwell plate discussed above wherein the two or more binding agents are printed onto the imaging zone, optionally at addressable locations, as in Claim 11.
However, the recitation “printed onto the imaging zone” is drawn to a process recitation. As the claims are drawn to a device, such process recitation is not afforded patentable weight when the prior art device is capable of performing the claimed process. "Apparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc. – MPEP 2114(II). Herein, the two or more binding agents of Panchapakesan as discussed above regarding Claim 9 are fully capable of being printed onto a device, and the device of Choi/Fang is fully capable of being printed upon.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Fang, as applied to Claims 1-3, 5-6, 12, 14-16 above, and in further view of Herz et al. (US 2006/0087911 A1), hereinafter “Herz”.
Regarding Claim 10, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi does not specifically teach the microwell plate discussed above wherein the microfluidic microplate comprises at least one port for the attachment of a vacuum source, as in Claim 10.
However, Herz teaches a respective microwell plate comprising channels, wherein the device includes a vacuum port 14 for the attachment of a vacuum pump ([0036]), wherein the use of vacuum is well-known in the art for promoting flow through a microfluidic device.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Choi/Fang so as to include at least one port for the attachment of a vacuum source, such as suggested by Herz, so as to promote flow through the device, thereby reducing error related to improper flow; and would have a reasonable expectation of success therein.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Fang, as applied to Claims 1-3, 5-6, 12, 14-16 above, and in further view of Kasman et al. (US PAT 5,459,300 A), hereinafter “Kasman”.
Regarding Claim 13, the prior art meets the limitations of Claim 1 as discussed above. Further, Choi/Fang does not specifically teach the microwell plate discussed above wherein the imaging zones comprise a thermal control device that regulates the temperature of the imaging zone, as in Claim 13.
However, Kasman teaches a respective microwell plate comprising a heater assembly (the thermal control device) for providing heat to the individual wells of the plate while maintaining accurate temperature control (abstract). Further, this assembly allows for wells of the device to be held at a specific temperature, such as the working temperature of a specific enzyme, or cycled through temperatures such as for PCR, thereby reducing error due to improper temperature conditions, and increasing the number of uses of the device, as would easily be understood by one having ordinary skill in the art.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the device of Choi/Fang so as to include a thermal control device that regulates the temperature of the imaging zone, such as suggested by Kasman, so as to allow for wells of the device to be held at a specific temperature, such as the working temperature of a specific enzyme, or cycled through temperatures such as for PCR, thereby reducing error due to improper temperature conditions, and increasing the number of uses of the device, as would easily be understood by one having ordinary skill in the art; and would have a reasonable expectation of success therein.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Choi in view of Fang, as applied to Claims 1-3, 5-6, 12, 14-16 above, and in further view of Matson et al. (US 2004/0049351 A1), hereinafter “Matson”.
Regarding Claim 17, Choi/Fang teaches a system comprising the microfluidic microplate according to Claim 1 (see Claim 1 above), comprising a substrate and a capture area (the common well) (Examiner further notes that, as currently claimed, the “capture area” refers to no more than an arbitrary designation of space of the device.), as in Claim 17.
Further regarding Claim 17, Choi/Fang does not specifically teach the system as comprising a capture probe that stably binds the analyte and a query probe that transiently binds to the analyte, wherein the capture probe is immobilized in the capture area, as in Claim 17.
However, it appears that Applicant has merely claimed the arrangement of performing an ELISA-type assay (which utilizes an immobilized capture probe and a reporter probe which “sandwich” an analyte of interest for detection/quantification) or similar assays thereof. Herein, Matson teaches a respective microwell plate in which a sandwich ELISA is performed using probes immobilized in a capture area ([0141]), and wherein the use of ELISA offers a rapid and accurate test result for an analyte of interest.
Thus, one of ordinary skill in the art before the effective filing date of the claimed invention would have found it obvious to modify the method of Choi/Fang so as to include a capture probe that stably binds the analyte; a query probe that transiently binds to the analyte and a capture area in which the capture probe is immobilized, such as suggested by Matson, so as to provide a sandwich ELISA-type assembly, wherein the use of ELISA offers a rapid and accurate test result for an analyte of interest; and would have a reasonable expectation of success therein.
Regarding Claim 18, Choi/Fang/Matson teaches a method to detect and/or quantify an analyte in a sample comprising:
providing a system according to Claim 17 (see Claim 17 above),
providing the sample containing the analyte (As Choi discusses sample being contained within the wells, as seen through the well images of Claim 5, Choi inherently teaches providing the sample containing the analyte.), and
detecting and/or quantifying the analyte in the sample (As Choi Fig. 5 shows a heat map of detected sample, Choi inherently teaches detecting the sample.),
as in Claim 18.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JOSEPH KASS whose telephone number is (703) 756-5501. The examiner can normally be reached Monday - Friday from 9:00 A.M. to 5:00 P.M. EST. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill Warden, can be reached at telephone number (571) 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at https://www.uspto.gov/patents/uspto-automated-interview-request-air-form.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center; and visit https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you need assistance from a USPTO Customer Service Representative, call (800) 786-9199 (IN USA OR CANADA) or (571) 272-1000.
/B.J.K./Examiner, Art Unit 1798
/NEIL N TURK/Primary Examiner, Art Unit 1798