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 Rejections - 35 USC § 112
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:
"first fluid delivery device" in claim 22 line 3.
After consulting the specification, it has been found that the “fluid delivery device” is a peristaltic pump or a syringe pump (Immediate application specification; Para. [0103]). As a result, the examiner will be interpreting “fluid delivery device” to be a peristaltic pump or a syringe pump or equivalents thereof.
"second fluid delivery device" in claim 22 line 5.
After consulting the specification, it has been found that the “fluid delivery device” is a peristaltic pump or a syringe pump (Immediate application specification; Para. [0103]). As a result, the examiner will be interpreting “fluid delivery device” to be a peristaltic pump or a syringe pump or equivalents thereof.
“a solute concentration measuring device” in claim 26 line 2.
After consulting the specification, it has been found that the “solute concentration measuring device” is “any known concentration measuring device” (Immediate application specification; Para. [0106]). As a result, the examiner will be interpreting “solute concentration measuring device” as “any known solute concentration measuring device”.
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.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5, and 7 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Kameoka (US20220364076A1).
Regarding claim 1, Kameoka discloses:
A high efficiency microfluidic bio‐barrier (HµB) platform (Kameoka; Abstract, Paras. [0002, 0004, 0006-0008]) comprising:
a first inlet (Kameoka; See the annotated figures 1A and 2 below; Paras. [0034, 0060, 0062]; the top inlet (Fig. 1A), Sample (Fig. 2) ) configured to receive a first fluid (Kameoka; See the annotated figures 1A and 2 below; Paras. [0034, 0060, 0062]; the top inlet (Fig. 1A), Sample (Fig. 2) );
a second inlet (Kameoka; See the annotated figures 1A and 2 below; Paras. [0034, 0060, 0062], bottom inlet (Fig. 1A), Buffer (Fig. 2)) configured to receive a second fluid (Kameoka; See the annotated figures 1A and 2 below; Paras. [0034, 0060, 0062], bottom inlet (Fig. 1A), Buffer (Fig. 2));
a first outlet (Kameoka; See the annotated figures 1A and 2 below; Paras. [0034, 0060, 0062], top outlet) to discharge the first fluid (Kameoka; Para. [0062]; the first inlet and first outlet are in fluid communication therefore the first fluid which is received by the first inlet will be discharged by the first outlet);
a second outlet (Kameoka; See the annotated figures 1A and 2 below; Paras. [0034, 0060, 0062], bottom outlet) to discharge the second fluid (Kameoka; Para. [0062]; the second inlet and second outlet are in fluid communication therefore the second fluid which is received by the second inlet will be discharged by the second outlet);
a first member (Kameoka; See annotated figure 1B; Top channel layer reads on the first member) configured to retain a biobarrier (Kameoka; See annotated figure 1B; the grouping of the first porous membrane, microchannel of the center channel layer, and the second porous nanomembrane read on the biobarrier; The grouping being defined as the biobarrier is retained between the top channel layer and the bottom channel layer.), the first member including a first microchannel (Kameoka; See annotated figures 1B and 2; Top channel layer reads on the first member, the first microchannel is the microchannel labeled within the top channel layer) in fluid communication with the first inlet (Kameoka; See annotated figures 1A and 1B, it can be seen that there is direct fluid communication between the top inlet and the microchannel in the top channel layer) to receive the first fluid and to pass the first fluid adjacent to a first face of the biobarrier (Kameoka; See annotated figure 2; The first face (labeled in annotated fig. 2) of the biobarrier is the side in contact with the sample (first fluid) in figure 2), the first outlet being in fluid communication with the first microchannel (Kameoka; Para. [0062], if there is fluid communication between the top inlet and top outlet it can only be through the microchannel); and
a second member (Kameoka; See annotated figure 1B; Bottom channel layer reads on the second member; the grouping of the first porous membrane, microchannel of the center channel layer, and the second porous nanomembrane read on the biobarrier) configured to retain the biobarrier (Kameoka; See annotated figure 1B; the grouping of the first porous membrane, microchannel of the center channel layer, and the second porous nanomembrane read on the biobarrier; The grouping being defined as the biobarrier is retained between the top channel layer and the bottom channel layer.), with the biobarrier being disposed between the first member and the second member (Kameoka; See annotated figure 1B; The central layer which contains the biobarrier is placed between the first and second members), the second member including a second microchannel (Kameoka; See annotated figure 1B; Bottom channel layer reads on the second member and there is a labeled microchannel present on the bottom layer which reads on the second microchannel) in fluid communication with the second inlet to receive the second fluid and to pass the second fluid adjacent to a second face of the biobarrier (Kameoka; See annotated figure 1B; the grouping of the first porous membrane, microchannel of the center channel layer, and the second porous nanomembrane read on the biobarrier; The second face of the biobarrier is the side where the second porous nanomembrane is in contact with the Buffer (first fluid) in figure 2; The first inlet, to first microchannel and first outlet are in fluid communication with one another, in that order, and the second fluid within the top microchannel is in direct contact (adjacent/across) the second face of the biobarrier) that is opposite the first face (Kameoka; See annotated figure 2; Since the first face is on the side of the biobarrier where the top microchannel is and the second face is on the other side of the biobarrier where the bottom microchannel then the second face is opposite of the first face), the second outlet being in fluid communication with the second microchannel (Kameoka; It can be seen in Fig. 1B that there is a connection between the bottom outlet and the microchannel).
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Regarding claim 2, Kameoka discloses all of the elements of the current invention as stated with respect to claim 1. Kameoka further discloses wherein the first inlet (Kameoka; top inlet, See the annotated Figs. 1A and 1B above (with respect to claim 1)), the second inlet (Kameoka; bottom inlet, See the annotated Figs. 1A and 1B above (with respect to claim 1)), the first outlet (Kameoka; top outlet , See the annotated Figs. 1A and 1B above (with respect to claim 1)) and the second outlet (Kameoka; bottom outlet, See the annotated Figs. 1A and 1B above (with respect to claim 1)) are disposed along a top of the high efficiency microfluidic bio‐barrier (HµB) platform (Kameoka; top channel layer, See the annotated Figs. 1A and 1B above (with respect to claim 1).
Regarding claim 5, Kameoka discloses all of the elements of the current invention as stated with respect to claim 1. Kameoka further discloses wherein each of the first member (Kameoka; top channel layer, See annotated figure 1B above (with respect to claim 1)) and the second member (Kameoka; bottom channel layer, See annotated figure 1B above (with respect to claim 1)) comprises a plate (Kameoka; It can be seen in figure 1B above (with respect to claim 1) that the top and bottom channel layers are “plates”).
Regarding claim 7, Kameoka discloses a microfluidic system (Kameoka; Abstract; Paras. [0002, 0004, 0006-0008]), comprising: the high efficiency microfluidic bio‐barrier (HµB) platform of claim 1 (see above claim 1). Kameoka further discloses wherein the first microchannel (Kameoka; See annotated figures 1B and 2; Top channel layer reads on the first member, the first microchannel is the microchannel labeled within the top channel layer) and the second microchannel (Kameoka; See annotated figure 1B; Bottom channel layer reads on the second member and there is a labeled microchannel present on the bottom layer which reads on the second microchannel) are formed parallel to one another (Kameoka; See annotated figure 1A which shows that all the microchannels are parallel to one another).
Claim(s) 1, 3-4, 8-9, 17, 19-22, and 27-31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Wikswo (US20190336971A1, Published 2019).
Regarding claim 1, Wikswo discloses
A high efficiency microfluidic bio‐barrier (HµB) platform (Wikswo; Abstract, Fig. 1D & 1E; Paras. [0127-0132], the platform is exemplified as the totality of the invention shown in figures 1D and 1E) comprising:
a first inlet (Wikswo; See annotated figure 1D below, the inlets are boxed by a dotted line and labeled "Inlets". The first inlet (not labeled) is to the left of the second inlet (125)) configured to receive a first fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the inlet is configured to receive a fluid);
a second inlet (Wikswo; See annotated figure 1D below, the inlets are boxed by a dotted line and labeled "Inlets", second inlet (125)) configured to receive a second fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the inlet is configured to receive a fluid);
a first outlet (Wikswo; See annotated figure 1D below, the outlets are circled by a dotted line and labeled "Outlets". The first outlet (not labeled) is to the right of the second outlet (128)) to discharge the first fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the outlet is configured to discharge a fluid; The fluid connection between all inlets and outlets is such that the first and second fluids will mix, therefore the first outlet will discharge the first fluid)
a second outlet (Wikswo; See annotated figure 1D below, the outlets are circled by a dotted line and labeled "Outlets", second outlet (128)) to discharge the second fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the outlet is configured to discharge a fluid; The fluid connection between all inlets and outlets is such that the first and second fluids will mix, therefore the second outlet will discharge the second fluid);
a first member (Wikswo; See annotated figures 1D and 1E below; Para. [0127], first chamber assembly (100); The first chamber assembly is the piece which house the first microchannel see annotate Fig. 1G below, the first member (first chamber assembly, 100) is the shaded portion not boxed with a dotted line) configured to retain a biobarrier (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0129, 0132]; Can see the porous membrane or biobarrier between the first and second members (first and second chamber assemblies 100, 120) in annotated figures 1E and 1G), the first member including a first microchannel (Wikswo; See annotated figure 1E below; first input channel (106) and first output channel (107)) in fluid communication with the first inlet (Wikswo; Abstract; true by the nature of a microfluidic microchannel and its inlet; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication) to receive the first fluid and to pass the first fluid adjacent to a first face of the biobarrier (Wikswo; See annotated figure 1E; It can be seen in the figure that the first microchannel (106 and 107) moves across a face of the biobarrier (136), first flow (113)), the first outlet being in fluid communication with the first microchannel (Wikswo; Abstract; The channels (106, 107) are in fluid communication with inlet (125) and are structurally capable of receiving the second fluid; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication); and
a second member (Wikswo; See annotated figures 1D and 1E below; Para. [0127], second chamber assembly (120); See annotate Fig. 1G below, the second member (second chamber assembly, 120) is the shaded portion boxed with a dotted line) configured to retain the biobarrier (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0129, 0132]; Can see the porous membrane or biobarrier between the first and second members (first and second chamber assemblies 100, 120) in annotated figures 1E and 1G), with the biobarrier being disposed between the first member and the second member (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0132]; It can be seen in figure 1E below that the biobarrier (136) is disposed between the first member and second member; first and second assemblies (100 and 120)), the second member including a second microchannel (Wikswo; See annotated figure 1E below; second input channel (126) and second output channel (127)) in fluid communication with the second inlet to receive the second fluid (Wikswo; Abstract; the channels (126,127) are in fluid communication with inlet (125) and are structurally capable of receiving the second fluid ; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication) and to pass the second fluid adjacent to a second face of the biobarrier (Wikswo; See annotated figure 1E; It can be seen in the figure that the second microchannel (106 and 107) moves across a face of the biobarrier (136), second flow (123)) that is opposite the first face (Wikswo; It can be seen in annotated figure 1E that the flow 113 and 123 are on opposite sides of biobarrier (136)), the second outlet being in fluid communication with the second microchannel (Wikswo; Abstract; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication).
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Regarding claim 3, Wikswo discloses all of the elements of the current invention as stated with respect to claim 1. Wikswo further discloses:
The high efficiency microfluidic bio-barrier (HμB) platform of claim 1 (see above claim 1), further including at least one frame (Wikswo; See annotated figures 1D and 1E; the first assembly (100) is read as the at least one frame since it is the outermost layer of the platform/assembly) that includes a window (Wikswo; See annotated figures 1D and 1E; first chamber (104), second chamber (124)) for viewing the biobarrier (Wikswo; Para. [0127]), the first inlet comprising a first port that projects outwardly from the at least one frame, the second inlet comprising a second port that projects outwardly from the at least one frame, the first outlet comprising a third port that projects outwardly from the at least one frame, and the second outlet comprising a fourth port that projects outwardly from the at least one frame (Wikswo; Can see in annotated figure 1D and 1E (below) that all inlets and outlets project outwardly from the frame of the platform) (Wikswo; The ports created by each respective inlet and outlet are what connect directly to their respective input and output tubes (110, 111, 130, 131); See the annotated figure 1E to see the input tubes which are noted by the dark black lines connect to the inputs and outputs of the platform), and the at least one frame includes four through apertures (Wikswo; The four through apertures are the two inlets and the two outlets) that are in fluid communication with the first port, the second port, the third port, and the fourth port, as well as the first microchannel and the second microchannel (Wikswo; The four through apertures are the two inlets and the two outlets. All are in fluid communication with one another as can be seen in the figures and due to the nature of the microchannels being in fluid contact with the same porous membrane).
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Regarding claim 4, Wikswo discloses all of the elements of the current invention as stated with respect to claim 3. Wikswo further discloses wherein the at least one frame (See above claim 3) comprises a plastic plate (Wikswo; Para. [0121], stackable transwell inserts (frame, first and second assemblies (100, 120)) fabricated from the plastic cyclic olefin copolymer (COC))
Regarding claim 8, Wikswo discloses all of the elements of the current invention as stated with respect to claim 1. Wikswo further discloses a microfluidic platform wherein
the first member comprises a first plate (Wikswo; See annotated figure 1E above, first base plate (labeled in annotated figure 1E)),
the second member comprises a second plate (Wikswo; See annotated figure 1E below, second base plate (121)),
the first microchannel comprises a void formed in the first member (Wikswo; See annotated figure 1E below, The first microchannel (106, 107) being a gap within the base plate of the frame is a void), and
the second microchannel comprises a void formed in the second member (Wikswo; See annotated figure 1E below, The second microchannel (126, 127) being a gap within the base plate of the frame is a void), with
the biobarrier (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0129, 0132]) being disposed between the first microchannel of the first plate and the second microchannel of the second plate (Wikswo; See annotated figure 1E below; the biobarrier (136) can be seen to be between the first (106, 107) and second (126, 127) microchannels).
Regarding claim 9, Wikswo discloses all of the elements of the current invention as stated with respect to claim 8. Wikswo further discloses wherein each of the first plate (See above claim 8) and the second plate (See above claim 8) comprises a clear transparent plastic plate (Wikswo; Para. [0121], fabricated from the plastic cyclic olefin copolymer (COC), which is inherently transparent).
Regarding claim 17, Wikswo discloses all of the elements of the current invention as stated with respect to claim 1. Wikswo further discloses wherein the first microchannel comprises an enlarged center region (Wikswo; See annotated figure 1E below; Boxed and labeled ) and the second microchannel comprises an enlarged center region (Wikswo; See annotated figure 1E below; Boxed and labeled), the first enlarged region and the second enlarged region being aligned with and being located directly above and below the biobarrier (Wikswo; See annotated figure 1E below; Can see that the enlarged regions are aligned with and placed above and below the biobarrier (136)), respectively.
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Regarding claim 19, Wikswo discloses all of the elements of the current invention as stated with respect to claim 1 (see above claim 1). Wikswo further discloses wherein the first inlet (Wikswo; See annotated figure 1D above, the inlets are boxed by a dotted line and labeled "Inlets". The first inlet (not labeled) is to the left of the second inlet (125)) and the second inlet (Wikswo; See annotated figure 1D above, the inlets are boxed by a dotted line and labeled "Inlets", second inlet (125)) are located side-by-side (Wikswo; See annotated figure 1E, first chamber (104), second chamber (124); See annotated figure 1D inlets and outlets labeled and side by side) and the first outlet (Wikswo; See annotated figure 1D above, the outlets are circled by a dotted line and labeled "Outlets". The first outlet (not labeled) is to the right of the second outlet (128)) and the second outlet (Wikswo; See annotated figure 1D above, the outlets are circled by a dotted line and labeled "Outlets", second outlet (128)) are located side-by-side (Wikswo; See annotated figure 1E, first chamber (104), second chamber (124); See annotated figure 1D inlets and outlets labeled and side by side) with a window defined therebetween (Wikswo; See annotated figures 1D and 1E; first chamber (104), second chamber (124); It can be seen that the window is between the inlets and outlets in the annotated figures 1D and 1E), the window configured to permit visual observation of the biobarrier (Wikswo; Para. [0124]) to determine a visual property of the biobarrier (Wikswo; Para. [0124]).
Regarding claim 20, Wikswo discloses all of the elements of the current invention as stated with respect to claim 19. Wikswo further discloses wherein the window (Wikswo; See annotated figures 1D and 1E; first chamber (104), second chamber (124)) is an empty aperture (Wikswo; See annotated figures 1D and 1E; the chambers or window can be seen to be a cylindrical hole or aperture in the platform all the way through).
Regarding claim 21, Wikswo discloses all of the elements of the current invention as stated with respect to claim 1. Wikswo further discloses wherein the biobarrier (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0129, 0132]) comprises a porous membrane (Wikswo; porous membrane filter (136), Para. [0129, 0132]) that supports a cellular structure (Wikswo; See annotated figure 1E, cells (118, 138), porous membrane filter (136)).
Regarding claim 22, Wikswo discloses all of the elements of the current invention as stated with respect to claim 1. Wikswo further discloses a first fluid delivery device (Wikswo; Paras. [0029-0030, 0033]; There is a fluid and media delivery system comprising multiple peristaltic pumps (Para. [0166])for input and output of the microfluidic platform system) to deliver the first fluid (Wikswo; Paras. [0029-0030, 0033]) to the first inlet (Wikswo; Paras. [0029-0030, 0033]) at a controllable first flow rate (Wikswo; Paras. [0029-0030, 0033]; Para. [0166], the pumps are run by the motor control system which has independent microprocessors which would allow for controllable flow rate); and a second fluid delivery device (Wikswo; Paras. [0029-0030, 0033]) to deliver the second fluid (Wikswo; Paras. [0029-0030, 0033]; Para. [0166], the pumps are run by the motor control system which has independent microprocessors which would allow for controllable flow rate) to the second inlet (Wikswo; Paras. [0029-0030, 0033]) at a controllable second flow rate (Wikswo; Paras. [0029-0030, 0033]; Para. [0166], the pumps are run by the motor control system which has independent microprocessors which would allow for controllable flow rate).
Regarding claim 27, Wikswo discloses all of the elements of the current invention as stated with respect to claim 22. Wikswo further discloses a visual observation device (Wikswo; Para. [0135]) adjacent to the high efficiency microfluidic bio‐barrier (HµB) platform (Wikswo; Para. [0135], confocal microscopy required that the visualization device (microscope or imager) is adjacent to what is being imaged); and wherein the first member includes a window adjacent to the biobarrier (Wikswo; See annotated figure 1E, the first chamber (1040 is seen to be adjacent to the porous membrane/biobarrier (136)), wherein the visual observation device is disposed adjacent to the window (Wikswo; Para. [0135], confocal microscopy required that the visualization device (microscope or imager) is adjacent to what is being imaged (window of culture plate)), and wherein the first member is configured to permit visual observation of the biobarrier by the visual observation device (Wikswo; Para. [0124) through the window to determine a visual property of the biobarrier (Wikswo; Para. [0124]).
Regarding claim 28, Wikswo discloses all of the elements of the current invention as stated with respect to claim 27. Wikswo further discloses wherein the window is an empty aperture (Wikswo; See annotated figures 1D and 1E; the chambers (104, 124) which are read to a window can be seen to be a cylindrical hole or aperture in the platform all the way through).
Regarding claim 29, Wikswo discloses all of the elements of the current invention as stated with respect to claim 27. Wikswo further discloses wherein the visual observation device is a microscope (Wikswo; Para. [0135] , confocal microscopy).
Regarding claim 30, Wikswo discloses all of the elements of the current invention as stated with respect to claim 22. Wikswo further discloses an electrical analyzer configured to determine an electrical property of the biobarrier(Wikswo; Paras. [0032, 0034-0039], impedance analyzer); wherein the platform includes a first electrode disposed adjacent to the first microchannel (Wikswo; Paras. [0033, 0036-0039]) and being electrically conductive (Wikswo; Para. [0070]; Electrically conductive is a requirement of an electrode), wherein the first electrode is electrically connected to the electrical analyzer (Wikswo; Abstract; Para. [0174]) to permit an electrical measurement of the biobarrier to determine the electrical property of the biobarrier (Wikswo; Para. [0070]; the transendothelial electrical resistance (TEER) is the measurement across the biobarrier (Para. [0151]; filter at the bottom of the transwell insert is the biobarrier)).
Regarding claim 31, Wikswo discloses all of the elements of the current invention as stated with respect to claim 30. Wikswo further discloses wherein the electrical properties of the biobarrier being measured are: an electrical impedance, an electrical voltage, and an electrical resistivity (Wikswo; Para. [0032, 0151, 0174]; voltage sensing, trans endothelial electrical resistance (TEER) measurement, electrical impedance spectroscopy).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Kameoka (US20220364076A1, Published 2022) as applied to claim 1 above and further motivated by Yamakawa (US20050148064, Published 2005).
Regarding claim 6, Kameoka discloses all of the elements of the current invention as stated with respect to claim 1.
Kameoka further discloses wherein the microchannels are of a parallel orientation to one another (Kameoka; Fig. 1A, See annotated figure 1 above with respect to claim 1; It is clear that the microchannels are parallel to one another); and with the first microchannel being located above in a different plane than the second microchannel (Kameoka; Fig. 1B, it can be seen that the different microchannels are on separate planes).
Kameoka fails to disclose wherein the first microchannel and the second microchannel define an X shape,
Yamakawa discloses a microfluidic device using a diffusion barrier or porous membrane between two microchannels which cross in an X shape (Yamakawa; Abstract; Figs. 2d, 2f, 3a, and 3d) with the goal of fractionating and or trapping target molecules. The cross-channel area, or where the two microchannels cross each other have an electrode set on either side with the two microchannels and membrane in between (Yamakawa; Para. [0034]; Fig. 3e).
Yamakawa has shown that the X shape made between two microchannels on different planes of one another is a concept established before the effective filing date of the claimed invention. Additionally, it has been held that a mere rearrangement of element without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because having parallel microchannels versus microchannels that cross each other in an X will still allow for materials of interest to travel between channels across the biobarrier. The benefits of this modification include allowing for the ability to test for the barrier fluid dynamics when less surface area contact is present between the microfluidic channels and biobarrier thus allowing for a wider breadth of biological modeling.
Claim(s) 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kameoka (US20220364076A1, Published 2022) as applied to claim 1 above.
Regarding claim 22, Kameoka discloses all of the elements of the current invention as stated with respect to claim 1.
Kameoka further discloses a microfluidic system, comprising: the high efficiency microfluidic bio‐barrier (HµB) platform (Kameoka; Abstract, Paras. [0002, 0004, 0006-0008]) of claim 1; a first fluid delivery device (Kameoka; [0030], fluid delivery device are the referenced micro pump systems; These referenced pump systems satisfy both the first and second fluid delivery devices as it delivers to all inlets present in the system; The micro pump system is considered a functional equivalent of a peristaltic or syringe pump system as the function, of said pump systems, is being satisfied by the micro pump systems) to deliver the first fluid (Kameoka; Para. [0042], first and second fluids are the initial solution (or sample as labeled in the figure) and the PBS buffer solution; See annotated figure 2 with respect to claim 1 above) to the first inlet (Kameoka; See annotated figure 2 with respect to claim 1 above) at a controllable first flow rate (Kameoka; Paras. [0050-0052]; shows the variability of the flow rates set; the pumps are used [0042], and a flow rate is established [0050-0052]], the pump inherently has a controllable flow rate because there is a variety of flow rates that can be set to different values and thus controlled); and
Kameoka is silent on a second fluid delivery device to deliver the second fluid to the second inlet. However, it would have been obvious to one of ordinary skill in the art before the effective filing date to include a second fluid delivery device for the second inlet, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. MPEP 2144.04(VI)(B).
Regarding claim 23, Kameoka discloses all of the elements of the current invention as stated with respect to claim 22. Kameoka further discloses wherein the first fluid (Kameoka; Para. [0042]; See annotated figure 2 with respect to claim 1 above, first fluid is Sample) is different than the second fluid (Kameoka; Para. [0042]; See annotated figure 2 with respect to claim 1 above, second fluid is Buffer).
Regarding claim 24, Kameoka discloses all of the elements of the current invention as stated with respect to claim 22. Kameoka further discloses wherein the first flow rate is different than the second flow rate (Kameoka; Para. [0042]; Shown that the flow rates going into the different inlets are different from one another).
Regarding claim 25, Kameoka discloses all of the elements of the current invention as stated with respect to claim 24. Kameoka further discloses wherein the first flow rate mimics a capillary flow rate and the second flow rate mimics an interstitial fluid flow rate (Kameoka; Paras. [0015-0020, 0042]).
While it is not explicitly stated within Kameoka that the flow rates are intended to mimic capillary and interstitial flow rates it is unnecessary since interstitial and capillary are relative definitions such that any flow rate within a microfluidic system would satisfy or fall under this terminology. It is suggested by the examiner to explicitly state the definitions of said flowrates within the specification or define the limits of the flowrates within the claim set.
Regarding claim 26, Kameoka discloses all of the elements of the current invention as stated with respect to claim 22. Kameoka further discloses a solute concentration measuring device (Kameoka; measuring concentration via dynamic light scattering (DLS) and viewing biobarrier Paras. [0043-0050]) configured to measure a concentration of solutes in at least one of the first outlet fluid and the second outlet fluid (Kameoka; measuring concentration and viewing biobarrier Paras. [0043-0050]; The majority of imaging and calculations were done and presented via the center outlet, which is being categorized as a portion of the biobarrier within this office action. However, the top outlet, first outlet, is being calculated and tested in Figs. 4A, 4B, 5A, and 5B of Kameoka (see Kameoka; Paras. [0050-0051], where nanoparticle tracking analysis (NTA) was used for liposome concentrations in the top outlet)).
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Claim(s) 10 and 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kameoka (US20220364076A1, Published 2022) as applied to claim 1 above, and further in view of Wikswo (US20190336971A1, Published 2019).
Regarding claim 10, Kameoka discloses all of the elements of the current invention as stated with respect to claim 1.
Kameoka further discloses the microfluidic platform including a first electrode and a second electrode (Kameoka; electrode; See annotated figure 1C below showing the electrode placement on to the top channel layer), first electrode being disposed along a top surface of the first member (Kameoka; Para. [0012, 0034, 0060]; See annotated Fig. 1C below ) and the second electrode being disposed along a bottom surface of the second member (Kameoka; Para. [0012, 0034, 0060]; See annotated Fig. 1C below).
Kameoka fails to disclose the first electrode with a first conductive lead and the second electrode with a second conductive lead.
Wikswo discloses a microfluidic device using stackable frame elements to create microchannels where the microchannels are separated by a porous membrane and includes electrodes for impedance measurements (Wikswo; Abstract). Wikswo further disclose wherein the electrodes used in the microfluidic platform has conductive leads attached to the electrodes (Wikswo; Para. [0151], wires (699)). The conductive leads according to Wikswo allow for the electrodes to take measurements as they are supplying the electrodes with energy to complete the required measurements (Wikswo; Para. [0151], wires (699))
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the electrodes of Kameoka by including the wires connected to the electrodes as taught by Wikswo to provide: the first electrode with a first conductive lead and the second electrode with a second conductive lead. Both Kameoka and Wikswo are directed to microfluidic platforms using electrodes for electrical measurements of the biological contents of the platforms. Wikswo teaches that the wires connected to the electrodes allows for the electrodes to receive electricity allowing for measurements and electrical manipulation as desired. This involves applying a known technique (microfluidic plate with electrodes connected to leads) to a similar device (microfluidic plate with electrodes) to yield predictable results (a microfluidic plate with electrodes connected to leads which are powering the measurement ability of the electrodes).
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Regarding claim 13, Kameoka discloses all of the elements of the current invention as stated with respect to claim 10.
Modified Kameoka discloses wherein there is a first conductive lead and a second conductive lead (As seen with respect to claim 10 above).
Kameoka is silent on wherein the first conductive lead and the second conductive lead are located at a first end of the high efficiency microfluidic bio‐barrier (HµB) platform.
However, it has been held that a mere rearrangement of elements without modification of the operation of the device involves only routine skill in the art. MPEP §2144.04 (VI)(C). The rearrangement in this case does not modify the operation of the device because as long as the conductive leads are attached to the electrodes there should be no electrical interruption to the power being supplied and thus no change in operation of the system. The benefits of this modification include allowing for the ability to save space and manage the organization of the wires connected to the electrodes since they will be on the same side of the microfluidic plate.
Regarding claim 14, Modified Kameoka discloses all of the elements of the current invention as stated with respect to claim 10.
Modified Kameoka further discloses, wherein the first electrode, the first member, the second member and the second electrode are oriented parallel to one another in a stacked arrangement (Kameoka; See annotated figure 1C above).
Regarding claim 15, Modified Kameoka discloses all of the elements of the current invention as stated with respect to claim 14.
Modified Kameoka further discloses, wherein each of the first member and the second member comprises a plate formed of a nonconductive material (Kameoka; Para. [0028]; polydimethylsiloxane (PDMS) is known to be a non-conductive material as a material property).
Regarding claim 16, Modified Kameoka discloses all of the elements of the current invention as stated with respect to claim 14.
Modified Kameoka further discloses, wherein the second electrode comprises a bottommost layer of the microfluidic bio‐barrier platform (Kameoka; Para. [0012, 0034, 0060]; See annotated Fig. 1C above).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kameoka (US20220364076A1, Published 2022) in view of Wikswo (US20190336971A1, Published 2019) as applied to claim 10 above, further in view of Chiu (US20200230605A1, Published 2020) and motivated by Selzer (US20200347338A1, Published 2020).
Regarding claim 11, Kameoka in view of Wikswo discloses all of the elements of the current invention as stated with respect to claim 10.
Kameoka in view of Wikswo discloses wherein the first electrode comprises a first electrode plate and the second electrode comprises a second electrode plate (See annotated figure 1C above; the first and second electrode plates are simply the electrodes shown).
Kameoka in view of Wikswo is silent on wherein the first electrode comprises a first electrode plate formed of a conductive plastic and the second electrode comprises a second electrode plate formed of the conductive plastic.
Chiu discloses a microfluidic platform for bio-particle sorting using electrically conductive electrodes for sorting the particles which are flowing through a microchannel between the two electrodes (Chiu; Abstract). The transparent conductive electrodes (Chiu; Para. [0039]) are said to be able to be made of a “transparent conducting films, indium tin oxide, transparent conductive oxides, conductive polymers…but not limited thereto” (Chiu; Para. [0039]).
Selzer discloses a multisensory sensor for use in a bioreactor (Selzer; Abstract) which measures the electrical impedance between the intracellular and extracellular fluids within cells of the bioreactor (Selzer Para. [0023]). Selzer further discloses that there is a demand to find cheaper electrodes (Selzer; Para. [0017]) and that conductive polymer electrodes are cheap to produce.
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrode plates of Kameoka in view of Wikswo with the electrode made of a transparent conductive film (indium tin oxide) and transparent conductive polymer as taught by Chiu in order to provide: a first and second electrode plate both formed of a conductive plastic material. Selzer teaches discloses that there is a demand to find cheaper electrodes (Selzer; Para. [0017]) and that conductive polymer electrodes are cheap to produce. This involves a simple substitution of one known element (a microfluidic device with electrodes) for another (a microfluidic device with conductive polymer electrodes) to obtain predictable results (a microfluidic device with more affordable electrodes made of a conductive polymer).
Regarding claim 12, Modified Kameoka (Kameoka in view of Wikswo, Chiu, and Selzer) discloses all of the elements of the current invention as stated with respect to claim 11.
Modified Kameoka further discloses wherein each of the first electrode plate and the second electrode plate is composed of a transparent plastic sheet bonded to a transparent electrically conductive film of indium-tin-oxide (Chiu; Para. [0039]).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Wikswo (US20190336971A1, Published 2019) as applied to claim 1 above, and further in view of Harvard (US20150004077A1, Published 2015).
Regarding claim 18, Wikswo discloses all of the elements of the current invention as stated with respect to claim 1.
Wikswo discloses a microfluidics device that contains fluid attachment of tubes inserted into the inlets and outlets of the microfluidic plate used for cellular migration and barrier migration dynamics (Wikswo; The ports created by each respective inlet and outlet are what connect directly to their respective input and output tubes (110, 111, 130, 131); See the annotated figure 1E to see the input tubes which are noted by the dark black lines connect to the inputs and outputs of the platform).
Wikswo fails to disclose wherein each of the first inlet, the second inlet, the first outlet and the second outlet comprises a Luer-lock.
Harvard discloses an organ on a chip microfluidic platform with the goal of modeling microphysiological systems (Harvard; Abstract).
Additionally, Harvard discloses the use of luer-locks at the locations of the fluidic ports (inlets and outlets) (Harvard; Para. [0047]), which allow for a plug-and-play functionality allowing for the reuse of tubes and media feeding systems (Harvard; Para. [0048]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the pressure fitting port connection of Wikswo for the luer-lock ports as taught by Harvard in order to provide: wherein each of the first inlet, the second inlet, the first outlet and the second outlet comprises a Luer-lock. Both Wikswo and Harvard are directed to microfluidics platformed aimed at modeling realistic microphysiology of cells. Harvard discloses that the Luer-lock ports allow for plug-and-play functionality allowing for the reuse of tubes and media feeding systems. This involves applying a known technique (Luer-locks in the inlet and outlets of a microfluidic device) to a similar device (microfluidic device using push fitting connections) to yield predictable results (a microfluidic device that allows for easy reusability of the feed and waste systems).
Claim(s) 32-37 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wikswo (US20190336971A1, Published 2019) in view of Chiu (US20200230605A1, Published 2020).
Regarding claim 32, Wikswo discloses:
A high efficiency microfluidic bio‐barrier (HµB) platform (Wikswo; Abstract, Fig. 1D & 1E; Paras. [0127-0132], the platform is exemplified as the totality of the invention shown in figures 1D and 1E) comprising:
a first inlet (Wikswo; See annotated figure 1D below, the inlets are boxed by a dotted line and labeled "Inlets". The first inlet (not labeled) is to the left of the second inlet (125)) configured to receive a first fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the inlet is configured to receive a fluid);
a second inlet (Wikswo; See annotated figure 1D below, the inlets are boxed by a dotted line and labeled "Inlets", second inlet (125)) configured to receive a second fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the inlet is configured to receive a fluid);
a first outlet (Wikswo; See annotated figure 1D below, the outlets are circled by a dotted line and labeled "Outlets". The first outlet (not labeled) is to the right of the second outlet (128)) to discharge the first fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the outlet is configured to discharge a fluid; The fluid connection between all inlets and outlets is such that the first and second fluids will mix, therefore the first outlet will discharge the first fluid)
a second outlet (Wikswo; See annotated figure 1D below, the outlets are circled by a dotted line and labeled "Outlets", second outlet (128)) to discharge the second fluid (Wikswo; Abstract; this is categorized as a microfluidic bioreactor so it can be understood that the outlet is configured to discharge a fluid; The fluid connection between all inlets and outlets is such that the first and second fluids will mix, therefore the second outlet will discharge the second fluid);
a first member (Wikswo; See annotated figures 1D and 1E below; Para. [0127], first chamber assembly (100); The first chamber assembly is the piece which house the first microchannel see annotate Fig. 1G below, the first member (first chamber assembly, 100) is the shaded portion not boxed with a dotted line) configured to retain a biobarrier (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0129, 0132]; Can see the porous membrane or biobarrier between the first and second members (first and second chamber assemblies 100, 120) in annotated figures 1E and 1G), the first member including a first microchannel (Wikswo; See annotated figure 1E below; first input channel (106) and first output channel (107)) in fluid communication with the first inlet (Wikswo; Abstract; true by the nature of a microfluidic microchannel and its inlet; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication) to receive the first fluid and to pass the first fluid adjacent to a first face of the biobarrier (Wikswo; See annotated figure 1E; It can be seen in the figure that the first microchannel (106 and 107) moves across a face of the biobarrier (136), first flow (113)), the first outlet being in fluid communication with the first microchannel (Wikswo; Abstract; The channels (106, 107) are in fluid communication with inlet (125) and are structurally capable of receiving the second fluid; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication);
a second member (Wikswo; See annotated figures 1D and 1E below; Para. [0127], second chamber assembly (120); See annotate Fig. 1G below, the second member (second chamber assembly, 120) is the shaded portion boxed with a dotted line) configured to retain the biobarrier (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0129, 0132]; Can see the porous membrane or biobarrier between the first and second members (first and second chamber assemblies 100, 120) in annotated figures 1E and 1G), with the biobarrier being disposed between the first member and the second member (Wikswo; See annotated figure 1E below; porous membrane filter (136), Para. [0132]; It can be seen in figure 1E below that the biobarrier (136) is disposed between the first member and second member; first and second assemblies (100 and 120)), the second member including a second microchannel (Wikswo; See annotated figure 1E below; second input channel (126) and second output channel (127)) in fluid communication with the second inlet to receive the second fluid (Wikswo; Abstract; the channels (126,127) are in fluid communication with inlet (125) and are structurally capable of receiving the second fluid ; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication) and to pass the second fluid adjacent to a second face of the biobarrier (Wikswo; See annotated figure 1E; It can be seen in the figure that the second microchannel (106 and 107) moves across a face of the biobarrier (136), second flow (123)) that is opposite the first face (Wikswo; It can be seen in annotated figure 1E that the flow 113 and 123 are on opposite sides of biobarrier (136)), the second outlet being in fluid communication with the second microchannel (Wikswo; Abstract; See annotated figure 1E the start of the fluid pathway is labeled and follow the dotted arrows to see the fluid communication); and
a first electrode (Wikswo; Paras. [0033, 0036-0039]) with a first conductive lead (Wikswo; Para. [0151], wires (699)) and a second electrode (Wikswo; Paras. [0033, 0036-0039]) with a second conductive lead (Wikswo; Para. [0151], wires (699)),
Wikswo fails to disclose the first electrode being disposed along a top surface of the first member and the second electrode being disposed along a bottom surface of the second member, wherein the first electrode comprises a first electrode plate formed of a conductive plastic and the second electrode comprises a second electrode plate formed of the conductive plastic.
Chiu discloses a microfluidic platform for bio-particle sorting using electrically conductive electrodes for sorting the particles which are flowing through a microchannel between the two electrodes (Chiu; Abstract). The platform has two electrodes on opposite sides of the microfluidic plate with the microchannel in between the electrodes (Chiu; Fig. 2, Para. [0037]). The transparent conductive electrodes (Chiu; Para. [0039]) are said to be able to be made of a “transparent conducting films, indium tin oxide, transparent conductive oxides, conductive polymers…but not limited thereto” (Chiu; Para. [0039]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the electrodes of Wikswo with the conductive plastic plate electrodes placed on either side of the microchannel as taught by Chiu in order to provide: the first electrode being disposed along a top surface of the first member and the second electrode being disposed along a bottom surface of the second member, wherein the first electrode comprises a first electrode plate formed of a conductive plastic and the second electrode comprises a second electrode plate formed of the conductive plastic. Wikswo and Chiu are directed to microfluidic plates using electrodes for molecular manipulation and sensing. This involves simple substitution of one known element (metallic electrodes) for another (electrodes made of a conductive polymer) to obtain predictable results (conductive polymer electrodes).
Regarding claim 33, Modified Wikswo discloses all of the elements of the current invention as stated with respect to claim 32.
Modified Wikswo fails to disclose wherein each of the first electrode plate and the second electrode plate is composed of a transparent plastic sheet bonded to a transparent electrically conductive film.
Chiu discloses a microfluidic platform for bio-particle sorting using electrically conductive electrodes for sorting the particles which are flowing through a microchannel between the two electrodes (Chiu; Abstract). The platform has two electrodes on opposite sides of the microfluidic plate with the microchannel in between the electrodes (Chiu; Fig. 2, Para. [0037]). The transparent conductive electrodes (Chiu; Para. [0039]) are said to be able to be made of a “transparent conducting films, indium tin oxide, transparent conductive oxides, conductive polymers…but not limited thereto” (Chiu; Para. [0039]).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to combine the electrodes of Wikswo with the electrodes made of a conductive transparent plastic plate with a transparent conductive film as taught by Chiu in order to provide: wherein each of the first electrode plate and the second electrode plate is composed of a transparent plastic sheet bonded to a transparent electrically conductive film. Wikswo and Chiu are directed to microfluidic plates using electrodes for molecular manipulation and sensing. This involves simple substitution of one known element (metallic electrodes) for another (electrodes made of a transparent plastic plate with a transparent conductive film) to obtain predictable results (transparent and conductive electrodes).
Regarding claim 34, Modified Wikswo discloses all of the elements of the current invention as stated with respect to claim 33.
Modified Wikswo fails to disclose wherein the transparent electrically conductive film is composed of indium tin oxide.
Chiu discloses a microfluidic platform for bio-particle sorting using electrically conductive electrodes for sorting the particles which are flowing through a microchannel between the two electrodes (Chiu; Abstract). The platform has two electrodes on opposite sides of the microfluidic plate with the microchannel in between the electrodes (Chiu; Fig. 2, Para. [0037]). The transparent conductive electrodes (Chiu; Para. [0039]) are said to be able to be made of a “transparent conducting films, indium tin oxide, transparent conductive oxides, conductive polymers…but not limited thereto” (Chiu; Para. [0039]) (indium tin oxide is a well-known transparent electrically conductive film).
Therefore, it would be obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the transparent electrically conductive film on the electrodes of Modified Wikswo by making the transparent electrically conductive film from indium tin oxide as taught by Chiu in order to provide: wherein the transparent electrically conductive film is composed of indium tin oxide. Wikswo and Chiu are directed to microfluidic plates using electrodes for molecular manipulation and sensing. This involves simple substitution of one known element (the transparent electrically conductive film) for another (indium tin oxide as the transparent electrically conductive film) to obtain predictable results (transparent and conductive electrodes).
Regarding claim 35, Modified Wikswo discloses all of the elements of the current invention as stated with respect to claim 32.
Modified Wikswo further discloses a microfluidic platform further including at least one frame (Wikswo; See annotated figures 1D and 1E; the first assembly (100) is read as the at least one frame since it is the outermost layer of the platform/assembly)) that includes a window (Wikswo; See annotated figures 1D and 1E; first chamber (104), second chamber (124)) for viewing the biobarrier (Wikswo; Para. [0127]), the first inlet comprising a first port that projects outwardly from the at least one frame, the second inlet comprising a second port that projects outwardly from the at least one frame, the first outlet comprising a third port that projects outwardly from the at least one frame, and the second outlet comprising a fourth port that projects outwardly from the at least one frame (Wikswo; Can see in annotated figure 1D and 1E (below) that all inlets and outlets project outwardly from the frame of the platform) (Wikswo; The ports created by each respective inlet and outlet are what connect directly to their respective input and output tubes (110, 111, 130, 131); See the annotated figure 1E to see the input tubes which are noted by the dark black lines connect to the inputs and outputs of the platform), and the at least one frame includes four through apertures (Wikswo; The four through apertures are the two inlets and the two outlets) that are in fluid communication with the first port, the second port, the third port, and the fourth port, as well as the first microchannel and the second microchannel (Wikswo; The four through apertures are the two inlets and the two outlets. All are in fluid communication with one another as can be seen in the figures and due to the nature of the microchannels being in fluid contact with the same porous membrane).
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Regarding claim 36, Modified Wikswo discloses all of the elements of the current invention as stated with respect to claim 35. Modified Wikswo discloses wherein the at least one frame (See above claim 3) comprises a plastic plate (Wikswo; Para. [0121], stackable transwell inserts (frame, first and second assemblies (100, 120)) fabricated from the plastic cyclic olefin copolymer (COC)).
Regarding claim 37, Modified Wikswo discloses all of the elements of the current invention as stated with respect to claim 36. Modified Wikswo discloses wherein the at least one frame comprises a clear transparent plastic plate (Wikswo; Para. [0121], fabricated from the plastic cyclic olefin copolymer (COC), which is inherently transparent).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DONAVAN L BRIDGES whose telephone number is (571)272-9636. The examiner can normally be reached Mon-Fri 8:00am-5:00pm EST.
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/D.L.B./Examiner, Art Unit 1758
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
