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 .
Status of the Claims
Claims 1, 4-5, 9, 11, and 39 have been amended; claims 6-7, 13-14, 16-19, 27, 31, 37-38, and 40-42 have been previously cancelled; and claims 15, 20-26, 28-30, and 32-36 have previously been withdrawn. Claims 1-5, 8-12, and 39 are currently examined herein.
Status of the Rejection
Applicant’s amendments to the claims have overcome the 35 U.S.C. § 112 and 35 U.S.C. § 103 rejections previously set forth in the Non-final Office Action mailed August 20th, 2025.
New grounds of rejection under 35 U.S.C. § 103 are necessitated by Applicant’s amendments.
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 1-5, 8, 10-12, and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Hoffman (US 2018/0315750 A1) in view of Nam (US 2015/0340436 A1), Kawata (Improved sensitivity of a graphene FET biosensor using porphyrin linkers. Japanese Journal of Applied Physics 2018. 57, pages 1-5), and Cranford (Packing efficiency and accessible surface area of crumpled graphene. Physical Review B. 2011; 84, 205451-1 to 205451-7); Georgakilas (Noncovalent Functionalization of Graphene and Graphene Oxide for Energy Materials, Biosensing, Catalytic, and Biomedical Applications 2016. Chem. Rev. 116, 5464-5519) is used as evidence for claim 39.
Regarding Claim 1, Hoffman teaches a biosensor (a system for analysis of biological and/or chemical materials [para. 0280]) comprising:
a field effect transistor (FET) (chemically-sensitive field-effect transistor 1 in Figs. 4A-4C [para. 0281]) comprising:
a source electrode (source 22 in Figs. 4A-4C [para. 0282]);
a drain electrode (drain 24 in Figs. 4A-4C [para. 0282]), wherein the source and drain electrodes are separated from each other by an electrode separation distance (source 22 and drain 24 are separated from one another and positioned relative to the graphene layer 30 so as to form a gate structure 26 [para. 0282]);
a channel layer between the source electrode and the drain electrode (graphene layer 30 between the source 22 and drain 24 in Fig. 4A-4C [para. 0282]),
a sample reservoir (well 28, which is formed by gate structure 26 and chamber walls 29a and 29b in Fig. 4A [para. 0280]) in fluidic contact with the channel layer (fluid may be delivered in well 28, which is in contact with graphene channel layer 30 as illustrated in Figs. 4A-4C [para. 0282]);
a sample solution (fluid may include one or more reactants, such as analytes, in addition to a nucleic acid template [para. 0065, 0004]) that is an ionic solution (fluid may include one or more reactants, such as analytes, in addition to a nucleic acid template [para. 0065, 0004]; polynucleotide solutions for sequencing are in ionic solution), wherein the sample solution is positioned in the sample reservoir (fluid is delivered into well 28 [para. 0282]);
a gate electrode (gate structure 26 [para. 0282]) configured to electrically contact the sample solution in the sample reservoir (FET sensor detects a change when a solution containing reactants is added to the gate region [para. 0282]);
Hoffman is silent on wherein the channel layer has a crumpled geometry having a crumpled ratio of between 50% and 55%; a sample solution having a target, and wherein the crumpled geometry of the channel increases a detection limit of the biosensor to molecules in the ionic solution; a probe anchored to the channel layer, wherein the probe binds the target in the ionic solution to form a probe-target complex, wherein the crumpled ratio provides an increase in a Debye length of at least 20% compared to an equivalent channel having a flat geometry; wherein the crumpled ratio of the channel layer increases an area of the target within the Debye length to increase a detection limit of the biosensor to targets in the ionic solution.
Nam teaches wherein the channel layer has a crumpled geometry (graphene channel layer is crumpled by thermally-induced texturing [para. 0063])
Hoffman and Nam are considered analogous art to the claimed inventions because they are in the same field of graphene FET sensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the channel layer of Hoffman to have a crumpled geometry, as taught by Nam, as increased surface area of textured graphene may enhance the degree of functionalization of the material and alter its chemical reactivity (Nam, [para. 0004]). It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Modified Hoffman is silent on a sample solution having a target; a probe anchored to the channel layer, wherein the probe binds the target in the ionic solution to form a probe-target complex, wherein the crumpled geometry of the channel increases a detection limit of the biosensor to molecules in the ionic solution; a probe anchored to the channel layer, wherein the probe binds the target in the ionic solution to form a probe-target complex, wherein the crumpled ratio provides an increase in a Debye length of at least 20% compared to an equivalent channel having a flat geometry; wherein the crumpled ratio of the channel layer increases an area of the target within the Debye length to increase a detection limit of the biosensor to targets in the ionic solution.
Kawata teaches a sample solution (sodium phosphate buffer [second para. col. 1, page 065103-2) that is an ionic solution (sodium phosphate buffer is ionic) having a target (IgE protein is target for aptamer sequence, provided on second para. first col., page 2); probe anchored to the channel (aptamer anchored to graphene channel via a linker, such as PBASE or TCPP [second and fourth paras. col. 1, page 2; also illustrated in Fig. 2c and 2d, page 2), wherein the probe binds the target in the ionic solution to form a probe-target complex (aptamer sequence, provided on second para. first col., page 2, is targeted for IgE protein to form a probe-target complex).
Modified Hoffman and Kawata are considered analogous art to the claimed inventions because they are in the same field of graphene FET sensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the channel layer of modified Hoffman to have a probe anchored to the channel layer, wherein the probe binds the target in the ionic solution to form a probe-target complex, as taught by Kawata, as surface modification of the graphene FET allows for detection of a target biomolecule, such as IgE (Kawata, [abstract]).
Modified Hoffman is silent on the channel layer has a crumpled geometry “having a crumpled ratio of between 50% and 55%.
Cranford teaches packing efficiency and surface area of crumpled graphene (abstract), and teaches the crumpling the graphene affects many properties of the graphene for sensors, such as increasing electrolyte contact with the graphene surface as well as other properties including variation in bands structure and electronic properties of the curvature (second para. col. 1, page 205451-5).
As the crumpled ratio of the crumpled graphene channel layer is made to have different crumpling ratios to increase electrolyte contact, as well as other properties including variation in bands structure and electronic properties of the curvature (Cranford, [second para. col. 1, page 205451-5]), the crumpled ratio affects the amount of electrolyte contact of the graphene layer, band structure, and electronic properties of the graphene (Cranford, [second para. col. 1, page 205451-5]). As amount of electrolyte contact in contact with the graphene surface is a variable that can be modified, among others, by adjusting the crumpled ratio of the graphene layer, the precise crumpled ratio would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed crumpled ratio of the graphene channel cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the crumpled ratio of the graphene channel of modified Hoffman to obtain crumpled ratio of between 50% and 55%. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.);
the limitations “wherein the crumpled geometry of the channel increases a detection limit of the biosensor to molecules in an ionic solution; wherein the crumpled ratio provides an increase in a Debye length of at least 20% compared to an equivalent channel having a flat geometry; wherein the crumpled ratio of the channel layer increases an area of the target within the Debye length to increase a detection limit of the biosensor to targets in the ionic solution” are functional recitations. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Hoffman teaches that the fluid comes into contact with the graphene channel (Hoffman, [para. 0064]), and, as outlined above, as the crumpled ratio of modified Hoffman is in the range of 50% to 55%, it is capable of performing the claimed functions above.
Regarding Claim 2, modified Hoffman teaches the biosensor of claim 1.
Hoffman teaches wherein the channel layer is formed of a two-dimensional layer of material selected from the group consisting of graphene, silicene, germanane, MoS2 (2D material may be graphene, silicene, germanane, and MoS2 [para. 0026]).
Regarding Claim 3, modified Hoffman teaches the biosensor of claim 1.
Hoffman teaches wherein the channel layer is formed of graphene (graphene layer 30 [para. 0282]).
Regarding Claim 4, modified Hoffman teaches the biosensor of claim 1.
Hoffman teaches a support substrate layer that supports the source electrode, the drain electrode and the channel layer (silicon substrate 10 in Figure 4A [para. 0281], on which the FET can be fabricated on [para. 0021]).
Hoffman is silent on wherein the support substrate is formed of a material capable of undergoing shrinkage transformation to thereby crumple the channel layer that is supported by the support substrate.
Nam teaches wherein the support substrate is formed of a material capable of undergoing shrinkage transformation to thereby crumple the channel layer that is supported by the support substrate (polymer 12, such as polystyrene, which shrinks when exposed to heat to buckle the monolayer 10 to become crumples 14 [paras. 0029. 0031]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the support substrate of modified Hoffman with a support substrate material capable of undergoing shrinkage transformation to thereby crumple the channel layer that is supported by the support substrate, as taught by Nam, as adding a support capable of shrinking is one method for crumpling the FET channel layer (Nam, [para. 0029]).
Regarding Claim 5, modified Hoffman teaches the biosensor of claim 1, and teaches a probe anchored to the channel by a linker molecule (as outlined in the claim 1 rejection, Kawata teaches an aptamer anchored to graphene channel via a linker, such as PBASE or TCPP [second and fourth paras. col. 1, page 2; also illustrated in Fig. 2c and 2d, page 2), wherein the probe is an aptamer (as outlined in the claim 1 rejection above, Kawata teaches IgE aptamer [second para. first col., page 2), wherein the probe has a sequence selected to specifically bind a target molecule (as outlined in the claim 1 rejection, Kawata teaches an aptamer sequence, provided on second para. first col., page 2, is targeted for IgE protein).
Regarding Claim 8, modified Hoffman teaches the biosensor of claim 1;
the limitation “wherein during use with the sample solution, a Debye length at the surface of the crumpled geometry is greater than a Debye length of an equivalent channel having a flat geometry” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, as outlined in the claim 1 rejection above, as the crumpled ratio of modified Hoffman is in the range of 50% to 55% and the structure of modified Hoffman is substantially identical to the apparatus of the instant application, it is capable of performing the claimed functions above.
Regarding Claim 10, modified Hoffman teaches the biosensor of claim 1.
Hoffman is silent on wherein the crumpled geometry corresponds to a multi-axial deformation or a uniaxial deformation of the channel layer.
Nam teaches wherein the crumpled geometry corresponds to a uniaxial deformation of the channel layer (the crumpled graphene geometry on polystyrene can be uniaxial [para. 0058]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the crumpled channel of modified Hoffman to correspond to a uniaxial deformation of the channel layer, as taught by Nam, as increased surface area of textured graphene may enhance the degree of functionalization of the material and alter its chemical reactivity (Nam, [para. 0004]).
Regarding Claim 11, modified Hoffman teaches the biosensor of claim 1.
Hoffman is silent on wherein the crumpled geometry corresponds to an average periodicity ranging between 1 nm and 100 nm and an average amplitude ranging between 1 nm and 100 nm.
Nam teaches that the crumples may be arranged with a predetermined spacing with a pitch of about 500 nm or less [para. 0036], and a root-mean-square roughness of about 500 nm or less [para. 0037]. The Examiner interprets the pitch and the root-mean-square roughness of the crumpled channel of Nam as average periodicity and average amplitude of the instant application, respectively.
Given the teachings of Nam regarding channel crumples with a pitch of about 500 nm or less, and a root-mean-square roughness of about 500 nm or less, it would be obvious to one or ordinary skill in the art prior to the effective filing date of the claimed invention to modify the channel geometry of modified Hoffman to have selected and utilized an average periodicity and an average amplitude within the disclosed respective range, including those amounts that overlap within the claimed range, as the electrical properties of graphene can be modulated via bending and shaping the graphene layer (Nam, [para. 0004]). It has been held that obviousness exists where the claimed ranges overlap or lie inside ranges disclosed by the prior art. See MPEP 2144.05 (I).
Regarding Claim 12, modified Hoffman teaches the biosensor of claim 1.
Hoffman is silent on wherein the channel layer is in continuous or discontinuous contact with a support substrate layer.
Nam teaches wherein the channel layer is in continuous or discontinuous contact with a support substrate layer (polystyrene [PS] substrate may conform to arbitrary geometries of the crumpled graphene [para. 0046], or can be transferred onto a different polymer substrate while maintaining the crumpled morphology [para. 0046]).
It would be obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the silicon substrate layer of modified Hoffman with polystyrene so that the channel layer is in continuous or discontinuous contact with a support substrate layer, as taught by Nam, as using a substrate that can conform to the channel layer allows for facile integration with other materials in unconventional ways (Nam, [para. 0046]).
Regarding Claim 39, Hoffman teaches a system (a system for analysis of biological and/or chemical materials [para. 0280]) comprising:
a field effect transistor FET (chemically-sensitive field-effect transistor 1 in Figs. 4A-4C [para. 0281]) having:
a source electrode (source 22 in Figs. 4A-4C [para. 0282]);
a drain electrode (drain 24 in Figs. 4A-4C [para. 0282]), wherein the source and drain electrodes are separated from each other by an electrode separation distance (source 22 and drain 24 are separated from one another and positioned relative to the graphene layer 30 so as to form a gate structure 26 [para. 0282]);
a channel layer between the source electrode and the drain electrode (graphene layer 30 in Fig. 4A-4C [para. 0282]),
a channel layer receiving surface that forms part of a sample reservoir (well 28, is formed by the graphene channel 30 and chamber walls 29a and 29b, as illustrated in Fig. 4A [para. 0280]);
wherein the amplifiable sample solution (fluid may include one or more reactants, such as analytes, in addition to a nucleic acid template [para. 0065, 0004]) is an ionic solution having the target polynucleotide (fluid may include one or more reactants, such as analytes, in addition to a nucleic acid template [para. 0065, 0004]; polynucleotide solutions for sequencing are in ionic solution), wherein the amplifiable sample solution is positioned in the sample reservoir (fluid is delivered into well 28 [para. 0282]);
an electrical detector electrically connected to the FET (CMOS structure may include a processor configured for controlling and detecting/measuring voltage changes [para. 0055]);
the amplifiable sample solution comprising ssDNA primers and amplification reagents to amplify the target polynucleotide (fluid may include one or more reactants, such as analytes, in addition to a nucleic acid template [para. 0065, 0004]),
the limitations “for detecting a target polynucleotide in an amplifiable sample solution; wherein during use the amplification sample solution contacts the channel layer receiving surface of the sample reservoir; and the electrical detector is configured to detect a level of ssDNA primer by detection of a change in a FET electrical parameter” are functional limitations. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Hoffman teaches that the FET sensor may use DNA hybridization [para. 0032]; that the fluid, or sample, is delivered into well 28 [para. 0282], and that binding or synthesis steps can be used to amplify the bound DNA [para. 0011]; and that the processor is configured to control the performance of one or more reactions involving a biological material and detecting or measuring changes in voltage based on the chemically-sensitive field transistor [para. 0055]. Thus, the chemically-sensitive field-effect transistor 1 and the electrical detector (processor) are configured to performed the claimed functions above;
Hoffman is silent on wherein the channel layer comprises a two-dimensional crumpled semiconductor material having a crumpled ratio of between 50% and 55%; and wherein ssDNA primers during use bind to the channel layer receiving surface by a noncovalent π-π interaction between the crumpled semiconductor material and an aromatic ring of the ssDNA at a higher affinity than dsDNA; wherein the crumpled ratio provides an increase in a Debye length of at least 20% compared to an equivalent channel having a flat geometry and increase an area of the ssDNA primers within the Debye length.
Nam teaches wherein the channel layer comprises a two-dimensional crumpled semiconductor material (graphene channel layer is crumpled by thermally-induced texturing [para. 0063], which can be two dimensional [para. 0026]).
Hoffman and Nam are considered analogous art to the claimed inventions because they are in the same field of graphene FET sensors. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the channel layer of Hoffman to channel layer a two-dimensional crumpled semiconductor material, as taught by Nam, as increased surface area of textured graphene may enhance the degree of functionalization of the material and alter its chemical reactivity (Nam, [para. 0004]);
the limitation “wherein ssDNA primers during use bind to the channel layer receiving surface by a noncovalent π-π interaction between the crumpled semiconductor material and an aromatic ring of the ssDNA at a higher affinity than dsDNA” is a functional limitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, Nam teaches that a channel with a crumpled channel can be made of graphene [para. 0041], which as evidenced by Georgakilas, has favorable π-π interactions with DNA ([entire page 5477 and Figure 6, page 5477]). Thus, the crumpled geometry channel of the FET biosensor of modified Hoffman is capable of performing the claimed function above.
Modified Hoffman is silent on the channel layer has a crumpled geometry “having a crumpled ratio of between 50% and 55%.
Cranford teaches packing efficiency and surface area of crumpled graphene (abstract), and teaches the crumpling the graphene affects many properties of the graphene for sensors, such as increasing electrolyte contact with the graphene surface and variation in bands structure and electronic properties of the curvature (second para. col. 1, page 205451-5).
As the crumpled ratio of the crumpled graphene channel layer is made to have different crumpling ratios to increase electrolyte contact, as well as other properties including variation in bands structure and electronic properties of the curvature (Cranford, [second para. col. 1, page 205451-5]), the crumpled ratio affects the amount of electrolyte contact of the graphene layer, band structure, and electronic properties of the graphene (Cranford, [second para. col. 1, page 205451-5]). As amount of electrolyte contact is a variable that can be modified, among others, by adjusting the crumpled ratio of the graphene layer, the precise crumpled ratio would have been considered a result effective variable by one having ordinary skill in the art before the effective filing date of the invention. As such, without showing unexpected results, the claimed crumpled ratio of the graphene channel cannot be considered critical. Accordingly, one of ordinary skill in the art before the effective filing date of the invention would have optimized, by routine experimentation, the crumpled ratio of the graphene channel of modified Hoffman to obtain crumpled ratio of between 50% and 55%. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.);
the limitations wherein the crumpled ratio provides an increase in a Debye length of at least 20% compared to an equivalent channel having a flat geometry and increase an area of the ssDNA primers within the Debye length” is a functional recitation. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, the fluid interacts comes into contact with the graphene channel (Hoffman, [para. 0064]), and, as outlined above, as the crumpled ratio of modified Hoffman is in the range of 50% to 55%, it is capable of performing the claimed functions above.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hoffman Nam, Kawata, Cranford, as applied to claim 1 above, and in view of Chin (Microfluidics-based diagnostics of infectious diseases in the developing world. Nature Medicine, 2011; 17(8), 1015-1020).
Regarding Claim 9, modified Hoffman teaches the biosensor of claim 1;
Hoffman teaches that the sample comprises a DNA sequence (DNA is isolated from a biological sample [para. 0009].
Hoffman is silent on the sample solution is unprocessed whole blood, plasma, saliva or sputum; the biosensor having a detection limit down to 600 nucleic acid molecules.
Chin teaches a biosensor microchip assay with easier handling of samples (abstract), and teaches the sample solution is unprocessed whole blood (<1 µL of unprocessed whole blood [first para. col. 1, page 1018]).
Modified Hoffman and Chin are considered analogous art to the claimed inventions because they are in the same field of biosensors with immobilized surface layers. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the sample solution of modified Hoffman to be unprocessed whole blood, as taught by Chin, as using unprocessed bloods allows for simplistic user use and the use of the biosensor in resource-limited settings (Chin, [first para. col. 2, page 1015);
the limitation “the biosensor having a detection limit down to 600 nucleic acid molecules” is a functional recitation of the biosensor of modified Hoffman. Apparatus claims cover what a device is, not what a device does [MPEP 2114(II)]. A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the instant case, as the apparatus of modified Hoffman is identical to the apparatus outlined in claim 9 of the instant application, and Chin teaches the sample solution is unprocessed whole blood (Chin [first para. col. 1, page 1018]), the biosensor of modified Hoffman is configured to perform the claimed function above.
Response to Arguments
Applicant's arguments, see Remarks Pgs. 9-14, filed 11/20/2025, with respect to the 35 U.S.C. § 103 rejections have been fully considered.
Applicant’s Argument #1
Applicant traverses the prior art of record by amending independent claim 1 to recite the channel layer has a crumpled geometry with a crumpled ratio “between 50% and 55%”, “a sample solution that is an ionic solution having a target, wherein the sample solution is positioned in the sample reservoir”, a probe anchored to the channel layer, wherein the probe binds the target in the ionic solution to form a probe-target complex, wherein the crumpled ratio provides an increase in a Debye length of at least 20$ compared to an equivalent channel having a flat geometry”, and “wherein the crumpled ratio of the channel layer increases an area of the target within the Debye length to increase a detection limit of the biosensor to targets in the ionic solution”. Independent claim 39 is amended similarly to claim 1 and patentable for similar arguments.
Examiner’s Response #1
Applicant argues have been fully considered, but are moot in terms of the new grounds of rejection above.
Applicant’s Argument #2
Applicant argues on pages 12-14 that as Hoffman uses a probe anchored to a microbead instead of the channel, Hoffman and Kawata (which teaches a probe anchored to a channel), cannot be fairly combined as Hoffman uses the microbeads to introduce the probe into a specific well.
Examiner’s Response #2
Applicant’s arguments have been fully considered but are not persuasive. As Kawata teaches a probe anchored to a channel, and one of ordinary skill in the art would consider substituting a microbead with a probe anchored with a channel with a probe attached. In addition, using a probe attached to a channel would not render Hoffman inoperable, as Hoffman would still be able to detect the target of interest with the probe attached to the channel.
Applicant’s Argument #3
Applicant argues on pages 13-14 that claim 9 is asserted to have an independent basis of patentability, as none of the cited references have a “detection limit down to 600 nucleic acid molecules” for an “unprocessed sample”.
Examiner’s Response #3
Applicant argues have been fully considered, but are moot in terms of the new grounds of rejection above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795