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 .
Status of Claims
Applicant's amendments to the claims filed 28 October 2025 have been entered. Applicant's remarks filed 28 October 2025 are acknowledged.
Claims 83, 87, are 91 – 94 are in status “Currently amended.” Claims 85, 86, 89, 90, 95, 96, and 97 are in status “Previously presented.” Claims 1 – 82, 84, and 88 are cancelled.
Response to Arguments
Applicant’s arguments, see Remarks page 6, filed 28 October 2025, with respect to the objections to the drawings have been fully considered and are persuasive in light of the amendments. The rejections to the claims have been withdrawn.
Applicant’s arguments, see Remarks page 7, filed 28 October 2025, with respect to the rejections under 112(b) have been fully considered and are persuasive in light of the amendment. The rejections to the claims have been withdrawn. However, a new rejection under 35 USC 112(b) is made in light of the amendments to the claims filed 28 October 2025.
Applicant’s arguments, see Remarks page 8, filed 28 October 2025, with respect to the rejection of independent claim 83 under Wolf et al have been fully considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Wolf et al in view of Brown. Detailed rejections of the dependent claims can be found below.
Applicant’s arguments, see Remarks page 11, filed 28 October 2025, with respect to the rejection of independent claim 94 under Wolf et al have been fully considered and are persuasive in light of the amendments. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Hyde et al in view of Brown. Detailed rejections of the dependent claims can be found below.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 88 and 89 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 89 and 90 are rejected as incomplete, due to their dependence on cancelled claims 88 and 84 respectively. These claims are not being further considered on the merit, as the limitations of the claims are not clear.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 83 and 85 – 87 are rejected under 35 U.S.C. 103 as being unpatentable over Wolf (US 6376233 B1, cited on the IDS submitted 21 July 2022) in view of Brown (US 6037168 A).
With regards to claim 83, Wolf et al teaches;
The claimed "a well array structure having through-holes" has been read on the taught (Column 2, line 18, "…a honeycomb-like tube structure consisting of a bottomless upper part of a commercially available microtiter plate…"; the plate being bottomless reads on the well array structure having through-holes.);
The claimed "a substrate carrying electrodes aligned with the through-holes of the well array structure to form wells of a nanopore sensing apparatus" has been read on the taught (Column 2, line 59, "Preferably, it is provided that the sensors, at least for some receptacles, are situated on a common wafer-like semiconductor substrate plate."; Column 5, line 45, "Besides the sensors 7, stimulus electrodes or the like can also be provided…"; Figure 5 clearly shows the electrodes aligned with the through-holes of the well array structure; The semiconductor substrate plate reads on a substrate. Stimulus electrodes read on electrodes.);
Wolf et al does not explicitly disclose wherein the well array structure is removably attached to the substrate.
According to MPEP 2144.04(V)(C), making components of a device separable may be prima facie obvious-- please see In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). In the case of the instant invention, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the well array as taught by Wolf et al with a removable base substrate, for the benefit of allowing easy access to replace the electrodes carried by the substrate.
The claimed "to form wells of a nanopore sensing apparatus" is functional language, and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As the structural limitations of the apparatus as defined in claims 83 are obvious over Wolf et al, this additional limitation does not define the instant application over the prior art.
However, Wolf et al does not explicitly disclose wherein a patterned adhesive adheres the well array structure and the substrate; wherein the patterned adhesive facilitates subsequent separation of the well array structure from the substrate for reuse and/or recycling, or wherein the patterned adhesive surface defines a plurality of portions without adhesive.
In the analogous art of microtiter plates, Brown teaches;
"Wherein a patterned adhesive adheres structures of a microtiter plate" and "wherein the patterned adhesive facilitates subsequent separation of the structures" have been read on the taught (Column 6, line 49, "According to some embodiments of the invention, the closure means comprises a patterned layer of an adhesive material disposed on the support surface. The patterned layer of adhesive material remains resealable, substantially intact, and adhered to or disposed on the support surface after adhering the cover to the support surface and then physically separating the cover from the support surface.").
According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the base device of a microtiter plate with a separable wall array is obvious over the prior art of Wolf et al. The prior art contains a comparable device of a microtiter plate with removable components, that has been improved by explicit teachings of a patterned adhesive to adhere components as taught by Brown. One of ordinary skill in the art could have applied the technique of using a patterned adhesive to adhere components together, in order to modify the base device of a microtiter plate with a separable well array. This would have the predictable result of allowing the well array to be adhered or removed from a bottom substrate.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microtiter plate including a separable wall array which is obvious over Wolf et al with the patterned adhesive as taught by Brown, for the predictable result of allowing the well array to be repeatedly removed and reattached from the base substrate.
The claimed "for reuse and/or recycling" is functional language, and has been given the appropriate patentable weight. Please see MPEP 2114(II), and Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). As Wolf et al in view of Brown teaches all of the structural limitations of the apparatus, this additional limitation does not define the instant application over the prior art.
Regarding the limitation “wherein the patterned adhesive surface defines a plurality of portions without adhesive”;
Brown teaches the claimed “wherein the patterned adhesive surface defines a plurality of portions without adhesive" as read on the taught (Column 11, line 1, "For example, the closure means may comprise… a pressure sensitive adhesive surrounding a layer of extremely hydrophobic non-adhesive material…"; a layer of non-adhesive material reads on a plurality of portions without adhesive.).
According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the base device of a microtiter plate with a separable well array structure, wherein a patterned adhesive adheres the well array structure is obvious over the prior art of Wolf et al in view of Brown. The prior art contains a comparable device of a microtiter plate including a patterned adhesive, which has been improved by the patterned adhesive defining portions without adhesive, as taught by Brown. One of ordinary skill in the art could have applied the technique of using a patterned adhesive defining regions without adhesive, in order to modify the base device of a microtiter plate with a separable well array. This would have the predictable result of allowing the well array to be adhered or removed from a bottom substrate with control over the amount of "grip" provided by the adhesive.
Regarding the teaching of a “plurality of portions without adhesive”, MPEP 2144.04(VI)(B) teaches that mere duplication of parts is prima facie obvious, provided that a no new or unexpected result is produced. The instant specification does not include any unexpected results occurring due to the plurality of portions without adhesive, and so this limitation is not patentably significant over the combination of Wolf et al in view Brown.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microtiter plate including a separable well array structure and patterned adhesive which is obvious over Wolf et al with the patterned adhesive defining a plurality of portions without adhesive as taught by Brown, for the predictable result of using less adhesive during the manufacturing process and controlling the amount of grip provided by the adhesive.
With regards to claim 85, the apparatus of claim 83 is obvious over Wolf et al in view of Brown.
Wolf et al additionally teaches;
The claimed "wherein the substrate comprises vias filled with a conductive material and the electrodes provided on the substrate are electrically connected to the conductive material," has been read on the taught (Column 5, line 32, "Moreover, there exists the possibility of arranging the control and evaluation facility 8 on the reverse side of the semiconductor substrate plate 2 facing away from the sensor structure and of connecting it through interlayer connections with the sensor terminals."; The interlayer connections read on the substrate comprising vias filled with conductive material. The control and evaluation facility being able to connect to the sensor terminal through the interlayer connections reads on the electrodes being electrically connected to the conductive material.).
With regards to claim 86, the apparatus of claim 85 is obvious over Wolf et al in view of Brown.
Wolf et al additionally teaches;
The claimed "wherein the substrate comprises contacts on a back side of the substrate opposite that of the electrodes, wherein the contacts can be used to connect to an electronic circuit" has been read on the taught (Column 5, line 32, "Moreover, there exists the possibility of arranging the control and evaluation facility 8 on the reverse side of the semiconductor substrate plate 2 facing away from the sensor structure and of connecting it through interlayer connections with the sensor terminals."; The sensor terminals read on contacts. The control and evaluation facility reads on an electronic circuit.).
With regards to claim 87, the apparatus of claim 86 is obvious over Wolf et al in view of Brown.
Wolf et al additionally teaches;
The claimed "wherein the nanopore sensing apparatus further comprises the electronic circuit, formed independently of said well array structure, connected to the electrical contacts" has been read on the taught (Column 5, line 32, "Moreover, there exists the possibility of arranging the control and evaluation facility 8 on the reverse side of the semiconductor substrate plate 2 facing away from the sensor structure and of connecting it through interlayer connections with the sensor terminals."; The sensor terminals read on contacts. The control and evaluation facility reads on an electronic circuit formed independently of said well array structure.).
Claim 91 is rejected under 35 U.S.C. 103 as being unpatentable over Wolf et al (US 6376233 B1, cited on the IDS submitted 21 July 2022) in view of Brown (US 6037168 A) and further in view of Hyde et al (WO 2014064443 A2, cited on the IDS submitted 21 July 2022).
With regards to claim 91, the apparatus of claim 83 is obvious over Wolf et al in view of Brown.
However, this combination fails to disclose wherein the well array structure includes two separate layers: a base layer having through-holes, and a support layer having pillars extending perpendicularly from surfaces adjacent each well.
In the analogous art of devices containing fluid compartments and sensors, Hyde et al teaches;
"A well array structure" has been read on the taught (Page 2, line 20, "…providing an apparatus comprising a support defining an array of compartments having openings…");
The claimed "wherein the well array structure includes two separate layers," comprising "a base layer", and "a support layer" has been read on the taught (Page 16, line 27, "The support 3 comprises a base 5 and partitions 6 that extend from the base 5."; The support 3 reads on a well array structure. Base 5 reads on a base layer. The partitions 6 read on a support layer.);
The claimed "a support layer having pillars extending perpendicularly from the surfaces adjacent each well" has been read on the taught (Page 16, line 22, "The partitions 6 comprise plural pillars 7 that extend out from the base 5 as shown in Fig. 3, in this example perpendicularly.");
Hyde et al additionally teaches wherein the base layer includes electrodes, as read on the taught (Page 7, line 20, "Where the apparatus comprises respective electrodes provided in each compartment, the electrodes may be provided at the base.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the well array structure including a layer with through-holes as taught by Wolf et al in view of Brown, with the structure including a base and a support layer with a variety of concepts as taught by Hyde et al, for the benefit of creating a device which facilitates the formation of membranes within each through-hole (Hyde et al, page 8, line 7, "The support may be designed as follows to facilitate formation of the membranes comprising amphipathic molecules.").
Claims 92 and 93 are rejected under 35 U.S.C. 103 as being unpatentable over Wolf et al (US 6376233 B1, cited on the IDS submitted 21 July 2022) in view of Brown (US 6037168 A) in view of Hyde et al (WO 2014064443 A2, cited on the IDS submitted 21 July 2022) and further in view of Fuller et al (WO 2006104839 A2).
With regards to claim 92, the apparatus of claim 91 is obvious over Wolf et al in view of Brown in view of Hyde et al.
However, this combination does not explicitly disclose wherein a base layer includes glass.
In the analogous art of multiwell sample plates with substrate electrodes, Fuller et al teaches;
"A well array structure" has been read on the taught ([00030], "…the device relates to a single well or multi-well plate 110 for conducting one or more assays…"; Well plate 110 reads on a well array structure.);
"A substrate carrying electrodes" has been read on the taught ([00039], "The impedance measuring electrodes 250 are formed in an array on the top surface of the bottom-plate 260…"; Bottom-plate 260 reads on a substrate carrying electrodes.);
"A base layer" has been read on the taught ([00030], "… the device relates to a single well or multi-well plate 110 for conducting one or more assays, the plate being formed from an upper plate…" The upper plate reads on a base layer );
The claimed "wherein a base layer includes glass" has been read on the taught ([00030], "Alternatively the upper 220 and bottom plates 260 may be formed from any material that can be molded into an appropriate shape. Materials such as plastics, elastomers, ceramics, composites, glass, carbon materials, or the like can be used.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the well array structure as taught by Wolf et al in view of Brown in view of Hyde et al with the base layer formed of glass as taught by Fuller et al, for the benefit of creating a device which is generally impervious to reagents, water, or solvents, which can withstand heat, and which is generally inexpensive (Fuller et al, [00030], "The upper- plate 220 and bottom-plate 260 are preferably formed from a material that is generally impervious to reagents typically encountered in biological assays, resistant to the adsorption of biomolecules, impervious to water and to organic solvents that are typically used to dissolve chemical libraries, and can withstand modest levels of heat. The upper-plate 220 and bottom-plate 260 are additionally made from a material that is sufficiently inexpensive to allow the devices to be disposed after one use, without large economic or ecological impacts.").
With regards to claim 93, the apparatus of claim 91 is obvious over Wolf et al in view of Brown and further in view of Hyde et al.
However, this combination does not explicitly disclose wherein a support layer includes glass.
In the analogous art of multiwell sample plates with substrate electrodes, Fuller et al teaches;
"A well array structure" has been read on the taught ([00030], "…the device relates to a single well or multi-well plate 110 for conducting one or more assays…"; Well plate 110 reads on a well array structure.);
"A substrate carrying electrodes" has been read on the taught ([00039], "The impedance measuring electrodes 250 are formed in an array on the top surface of the bottom-plate 260…"; Bottom-plate 260 reads on a substrate carrying electrodes.);
"A support layer" has been read on the taught ([00030], "… the device relates to a single well or multi-well plate 110 for conducting one or more assays, the plate being formed from an upper plate…" The upper plate reads on a support layer );
The claimed "wherein a support layer includes glass" has been read on the taught ([00030], "Alternatively the upper 220 and bottom plates 260 may be formed from any material that can be molded into an appropriate shape. Materials such as plastics, elastomers, ceramics, composites, glass, carbon materials, or the like can be used.").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the well array structure as taught by Wolf et al in view of Brown in view of Hyde et al with the support layer formed of glass as taught by Fuller et al, for the benefit of creating a device which is generally impervious to reagents, water, or solvents, which can withstand heat, and which is generally inexpensive (Fuller et al, [00030], "The upper- plate 220 and bottom-plate 260 are preferably formed from a material that is generally impervious to reagents typically encountered in biological assays, resistant to the adsorption of biomolecules, impervious to water and to organic solvents that are typically used to dissolve chemical libraries, and can withstand modest levels of heat. The upper-plate 220 and bottom-plate 260 are additionally made from a material that is sufficiently inexpensive to allow the devices to be disposed after one use, without large economic or ecological impacts.").
Claims 94 and 95 is rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al (WO 2014064443 A2, cited on the IDS submitted 21 July 2022) in view of Brown.
With regards to claim 94, Hyde et al teaches;
"A well array structure having through-holes" has been read on the taught (Page 2, line 20, "…providing an apparatus comprising a support defining an array of compartments having openings…");
The claimed "a substrate carrying electrodes aligned with the through-holes of the well array structure to form wells of a nanopore sensing apparatus" has been read on the taught (Page 7, line 20, "Where the apparatus comprises respective electrodes provided in each compartment, the electrodes may be provided at the base."; The base with provided electrodes reads on a substrate carrying electrodes.).
The claimed "aqueous volumes, wherein each aqueous volume is held in a well of the well array" has been read on the taught (Page 4, line 8, "…volumes comprising polar medium may be dispensed directly into individual compartments…"; Page 4, line 12, "Where the volumes comprising polar medium are preformed, they may be droplets of an aqueous buffer solution…"; Aqueous buffer solution dispensed into individual compartments read on aqueous volume held in a well of the well array.);
The claimed "membranes, wherein each membrane is formed across a well" has been read on the taught (Page 2, line 31, "Such a method provides a convenient and effective way to form an array of membranes comprising amphipathic molecules.");
The claimed "nanopores, wherein each nanopore is inserted into a membrane of the membranes" has been read on the taught (Page 40, line 9, "The apparatus 1 may have membrane proteins inserted into the membranes comprising amphipathic molecules formed at the interfaces 51. The membrane proteins may be ion channels or pores."; Page 40, line 35, "The ion channel may be a nanopore for determining the sequence of a polynucleotide."; Membrane proteins which may be nanopores read on a nanopore inserted into a membrane.);
However, Hyde et al does not explicitly disclose wherein the well array structure is removably attached to the substrate.
According to MPEP 2144.04(V)(C), making components of a device separable may be prima facie obvious-- please see In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). In the case of the instant invention, it would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the well array as taught by Hyde et al with a removable base substrate, for the benefit of allowing easy access to replace the electrodes carried by the substrate.
However, Hyde et al does not explicitly disclose wherein a patterned adhesive adheres the well array structure and the substrate, wherein the patterned adhesive surface defines a plurality of portion without adhesive.
In the analogous art of microtiter plates, Brown teaches;
"Wherein a patterned adhesive adheres structures of a microtiter plate" has been read on the taught (Column 6, line 49, "According to some embodiments of the invention, the closure means comprises a patterned layer of an adhesive material disposed on the support surface. The patterned layer of adhesive material remains resealable, substantially intact, and adhered to or disposed on the support surface after adhering the cover to the support surface and then physically separating the cover from the support surface.");
According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the base device of a well array and a substrate is obvious over the prior art of Hyde et al. The prior art contains a comparable device of a microtiter plate with removable components, that has been improved by explicit teachings of a patterned adhesive to adhere components as taught by Brown. One of ordinary skill in the art could have applied the technique of using a patterned adhesive to adhere components together, in order to modify the base device of a microtiter plate with a separable well array. This would have the predictable result of allowing the well array to be adhered or removed from a bottom substrate.
Accordingly, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wall array and substrate which is obvious over Hyde et al with the patterned adhesive as taught by Brown, for the predictable result of allowing the well array to be repeatedly removed and reattached from the base substrate.
Regarding the limitation “wherein the patterned adhesive surface defines a plurality of portions without adhesive”;
Brown teaches the claimed “wherein the patterned adhesive surface defines a plurality of portions without adhesive" as read on the taught (Column 11, line 1, "For example, the closure means may comprise… a pressure sensitive adhesive surrounding a layer of extremely hydrophobic non-adhesive material…"; a layer of non-adhesive material reads on a plurality of portions without adhesive.).
According to MPEP 2143(I)(C), use of a known technique to improve similar devices in the same way may be prima facie obvious. In the case of the instant invention, the base device of a well array and a substrate, wherein a patterned adhesive adheres the well array structure is obvious over the prior art of Hyde et al in view of Brown. The prior art contains a comparable device of a microtiter plate including a patterned adhesive, which has been improved by the patterned adhesive defining a plurality of portions without adhesive, as taught by Brown. One of ordinary skill in the art could have applied the technique of using a patterned adhesive defining regions without adhesive, in order to modify the base device of a microtiter plate with a separable well array. This would have the predictable result of allowing the well array to be adhered or removed from a bottom substrate with control over the amount of "grip" provided by the adhesive.
Regarding the teaching of a “plurality of portions without adhesive”, MPEP 2144.04(VI)(B) teaches that mere duplication of parts is prima facie obvious, provided that no new or unexpected result is produced. The instant specification does not include any unexpected results occurring due to the plurality of portions without adhesive, and so this limitation is not patentably significant over the combination of Hyde et al in view Brown.
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the microtiter plate including a separable well array structure and patterned adhesive which is obvious over Hyde et al with the patterned adhesive defining a plurality of portions without adhesive as taught by Brown, for the predictable result of using less adhesive during the manufacturing process and controlling the amount of grip provided by the adhesive.
With regards to claim 95, the apparatus of claim 94 is obvious over Hyde et al in view of Brown.
Hyde et al additionally teaches;
The claimed "wherein each membrane is an amphiphilic membrane" has been read on the taught (Page 3, line 1, "…the present invention relates to the formation of an array of membranes comprising amphipathic molecules using an array of volumes of polar medium."; Membranes comprising amphipathic molecules reads on a membrane being an amphiphilic membrane.);
The claimed wherein each membrane "supports a biological nanopore" has been read on the taught (Page 40, line 9, "The apparatus 1 may have membrane proteins inserted into the membranes comprising amphipathic molecules formed at the interfaces 51. The membrane proteins may be ion channels or pores."; Page 40, line 35, "The ion channel may be a nanopore for determining the sequence of a polynucleotide."; Page 40, line 34, "…Fig. 41 shows electrical data obtained for measurement of ion current flow through an MspA nanopore illustrating pore insertion."; An MspA nanopore reads on a biological nanopore.).
Claims 96 and 97 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al (WO 2014064443 A2, cited on the IDS submitted 21 July 2022) in view of Ju et al (US 20150119259 A1).
With regards to claim 96, the apparatus of claim 94 is obvious over Hyde et al in view of Brown.
However, Hyde et al in view of Brown does not explicitly disclose wherein each membrane is a solid-state membrane and has a solid-state nanopore.
In the analogous art of nanopore device, Ju et al teaches;
"A nanopore sensing apparatus comprising a membrane disposed over a well" has been read on the taught ([0131], "The nanopore may be formed or otherwise embedded in a membrane disposed adjacent to a sensing electrode of a sensing circuit…"; [0134], "… the membrane 205 can be disposed over a well 210…");
The claimed "wherein each membrane is a solid-state membrane and has a solid-state nanopore" has been read on the taught ([0429], "In an embodiment of the methods the nanopore is a solid-state nanopore. In an embodiment of the methods the nanopore is in a solid-state membrane.").
According to MPEP 2143(I)(A), simple substitution of one known element for another to obtain predictable results is may be prima facie obvious. In the case of the instant invention, the prior art of Hyde et al contains a nanopore sensing device that differs from the claimed device only by the lack of a solid-state membrane and a solid-state nanopore, instead teaching an amphiphilic membrane and a biological nanopore. As shown by Ju et al, the substituted components of a solid-state membrane and a solid-state nanopore and their functions as sensing components were known in the art. One of ordinary skill in the art could have substituted the known elements of a solid-state membrane and a solid-state nanopore for the known elements an amphiphilic membrane and biological nanopore; this substitution would have the predictable result of allowing molecules to flow through the nanopore for detection by a circuit (Ju et al, [0132], "In some cases, as a nucleic acid or tag flows through the nanopore, the sensing circuit detects an electrical signal associated with the nucleic acid or tag."). Indeed, Ju et al even teaches that a biological nanopore or a solid-state nanopore may be used (see [0240]), and that a membrane may be additionally be a lipid bilayer (see [0246]).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing device including wells and electrodes as taught by Hyde et al in view of Brown with the solid-state membrane and solid-state nanopore as taught by Ju et al, with the predictable result of allowing molecules to flow through a nanopore for detection by a circuit.
With regards to claim 97, the apparatus of claim 94 is obvious over Hyde et al in view of Brown.
However, Hyde et al in view of Brown does not explicitly disclose wherein each membrane is a solid-state membrane and supports a biological nanopore in a hole within the solid-state membrane.
In the analogous art of nanopore device, Ju et al teaches;
"A nanopore sensing apparatus comprising a membrane disposed over a well" has been read on the taught ([0131], "The nanopore may be formed or otherwise embedded in a membrane disposed adjacent to a sensing electrode of a sensing circuit…"; [0134], "… the membrane 205 can be disposed over a well 210…");
The claimed "wherein each membrane is a solid-state membrane and supports a biological nanopore in a hole within the solid-state membrane" has been read on the taught ([0577], "In an embodiment the nanopore a solid-state membrane. In an embodiment the membrane is a silicon nitride membrane. In an embodiment the nanopore is a biopore. In an embodiment the pore is proteinaceous."; The silicon nitride membrane reads on a solid-state membrane. The nanopore being a biopore reads on a biological nanopore).
According to MPEP 2143(I)(A), simple substitution of one known element for another to obtain predictable results is may be prima facie obvious. In the case of the instant invention, the prior art of Hyde et al in view of Brown contains a nanopore sensing device that differs from the claimed device only by the lack of a solid-state membrane and a biological nanopore, instead teaching an amphiphilic membrane and a biological nanopore. As shown by Ju et al, the substituted components of a solid-state membrane and a solid-state nanopore and their functions as sensing components were known in the art. One of ordinary skill in the art could have substituted the known elements of a solid-state membrane and a biological nanopore for the known elements an amphiphilic membrane and biological nanopore; this substitution would have the predictable result of allowing molecules to flow through the nanopore for detection by a circuit (Ju et al, [0132], "In some cases, as a nucleic acid or tag flows through the nanopore, the sensing circuit detects an electrical signal associated with the nucleic acid or tag."). Indeed, Ju et al even teaches that a biological nanopore or a solid-state nanopore may be used (see [0240]).
As such, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing device including wells and electrodes as taught by Hyde et al in view of Brown with the solid-state membrane and biological nanopore as taught by Ju et al, with the predictable result of allowing molecules to flow through a nanopore for detection by a circuit.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ALISON CLAIRE GERHARD/Examiner, Art Unit 1797
/LYLE ALEXANDER/Supervisory Patent Examiner, Art Unit 1797