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 and 9-27 are currently pending, and claims 11-27 are examined herein.
Status of the Rejection
The 35 U.S.C. § 102 and 103 rejections of claims 11-27 from the previous office action are maintained.
Claim Rejections - 35 USC § 102
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 11-13, 15-16, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Diamond (US 20200326325 A1).
Regarding claim 11, Diamond teaches a sensor assembly (nanosensor chip 100 in Fig. 1 with a cross-section of compore 900 shown in Fig. 9 [0022, 0049]) comprising:
a substrate having a first side, a second side opposite the first side, and a through hole extending from the first side to the second side (the silicon nitride layer 930 in Fig. 9, wherein the top is the first side, and the bottom is the second side, includes a through hole [0050]);
a sensing element having a sample side and a buffer side opposite the sample side (the silicon layer 910 in Fig. 9 is deemed as the sensing element, wherein the bottom is the sample side, and the top is the buffer side [0049]), the sample side of the sensing element mounted to the first side of the substrate (the bottom of silicon 910 is mounted to the top of silicon nitride 930); and
a working electrode disposed on the second side of the substrate, the working electrode disposed at least partially about the through hole (electrode 950 is disposed on the bottom of silicon nitride 930 about the through hole in Fig. 9).
Regarding claim 12, Diamond teaches the sensor assembly of Claim 11, and further teaches wherein the sensing element comprises a plurality of nanopores through the sensing element (nanopores 130 in Fig. 1 correspond to conical nanopores 130 in Fig. 5 and annotated Fig. 9 below) and a plurality of cavities on the buffer side (each compore 120 in Fig. 1 has a cavity formed by compore sidewall 220 shown in Fig. 2, also see annotated Fig. 9).
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Annotated Fig. 9 from Diamond
The limitation “wherein the sample side of the sensing element is configured to contact a test sample” 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, Diamond teaches a sensing element that is configured to perform the functional limitations above (as shown in Fig. 5a, the bottom end of the nanopores in the sensing element layer is exposed to the sample solution with target molecule 530 [0040]).
The limitation “the buffer side is configured to contact a control material” is a functional recitation. In the instant case, Diamond teaches a sensing element that is configured to perform the functional limitations above (the side of the compore opposite of the side exposed to the sample is exposed to a buffer solution [0034]; thus, the buffer side is configured to contact a buffer solution).
Regarding claim 13, Diamond teaches the sensor assembly of Claim 12, and further teaches wherein each of the plurality of nanopores comprises a functionalized layer (the nanopores are functionalized with a layer of probe molecules 520 in Fig. 5A and 5B [0041]).
Regarding claim 15, Diamond teaches the sensor assembly of Claim 11, wherein the sensing element includes no electrical interconnect (the electrodes may connect to an off-chip source and/or detector, such that no electrical interconnect is required on-chip [0025]).
Regarding claim 16, Diamond teaches the sensor assembly of Claim 11, further comprising an electrical component mounted on the substrate (the electrodes may connect to on-chip circuitry [0025]).
Regarding claim 18, Diamond teaches the sensor assembly of Claim 11, wherein the sensing element comprises silicon (the sensing element is silicon 910 in Fig. 9 [0049]).
Claims 11, 14, and 17 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Ackley et al. (US 6287517 B1). Dupont (“DuPont™ Kapton® Summary of Properties,” 2022, Dupont, pgs. 1-20) is applied as evidence for claim 17.
Regarding claim 11, Ackley teaches a sensor assembly (laminated structure 30 for biological diagnostics in Fig. 2 [col. 5, lines 15-27; col. 8, lines 1-4]) comprising:
a substrate having a first side, a second side opposite the first side, and a through hole extending from the first side to the second side (planar support 40 wherein the lower surface 46 is the first side, and the upper surface 44 is the second side, includes electrode through region 38 [col. 8, lines 7-17]);
a sensing element having a sample side and a buffer side opposite the sample side, the sample side of the sensing element mounted to the first side of the substrate (the combined planar supports 40a-40c are deemed as the sensing element and disposed on lower surface 46 in Fig. 2, wherein support 40a is on the sample side and support 40c is on the buffer side [col. 9, lines 10-15]); and
a working electrode disposed on the second side of the substrate (electrode 32 is disposed on upper surface 44 in Fig. 2 [col. 8, lines 1-7]), the working electrode disposed at least partially about the through hole (electrode 32 surrounds electrode through hole 38 in Fig. 2 [col. 8, lines 1-7]).
Regarding claim 14, Ackley teaches the sensor assembly of Claim 11, and further teaches the sensor comprising an adhesion layer disposed between the substrate and the sensing element (adhesive is disposed between the various sample support layers, including between supports 40 and 40a [col. 9, lines 21-23]).
Regarding claim 17, Ackley teaches the sensor assembly of Claim 11, and further teaches wherein the substrate is a flexible substrate (planar support 40 consists of Dupont Kapton brand polyimide [col. 8, lines 63-67]. As evidenced by Dupont, Kapton polyimide products are flexible substrates [pg. 2, col. 1, para. 1; pg. 18, caption of right-hand image]).
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 19-21 and 23-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Diamond in view of Sundvor et al. (US 20180188239 A1).
Regarding claim 19, Diamond teaches a sample testing device comprising:
a compartment (chip receptacle 1020 in Fig. 10 receives nanosensor chip 1010 corresponding to the chip described in Figs. 1 and 9, and the chip receptacle 1020 receives the liquid samples and buffer liquids exposed to chip 1010 [0052-0053]); and
wherein the sensor assembly of Claim 11 (see the rejection of claim 11 above, wherein the nanosensor chip in Figs. 1 and 9 teaches the sensor assembly of claim 11) is disposed in the second compartment (chip receptacle 1020 in Fig. 10 receives nanosensor chip 1010 [0053]).
Diamond is silent to the limitation wherein the device comprises a first compartment configured to receive a test sample, and a second compartment configured to receive the test sample from the first compartment, wherein the sensor assembly is disposed in the second compartment.
Sundvor teaches a sample testing device (the test container in Fig. 2A detects a target substance [0019, 0022]) comprising a first compartment (first chamber 110 and second chamber 130 connected via opening 132 in Fig. 2A [0019, 0040]); a second compartment (analysis chamber 140 is connected to second chamber 130 via outlet port 136 in Figs. 2A and 6A [0019, 0037]); and wherein a sensor assembly is disposed in the second compartment (detection substrate 150 is disposed in analysis chamber 140 in Fig. 2A [0019]). The device also includes a first compartment housing that at least partially defines the first compartment in an activated position via a plunging function (driving element 120 defines the closed first compartment during sample loading by sliding driving element 120 between openings 112 and 114 in Fig. 2A [0028-0029]). Sundvor further teaches that having two compartments separated by an outlet port enables on-device sample preparation and delivery of a controlled sample volume to the sensor assembly [0019, 0042, 0044].
Diamond and Sundvor are both considered analogous to the claimed invention because they are in the same field of sensors for detecting target molecules. 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 compartment in Diamond to a compartment including a first compartment and a second compartment connected with an outlet port, wherein the sensor assembly is disposed in the second compartment; and further modify the device by including a first compartment housing, as taught in Sundvor, since this would enable on-device sample preparation and delivery of a controlled sample volume to the sensor assembly [0019, 0042, 0044 in Sundvor]. Furthermore, Sundvor teaches the claimed improvement as a known technique that is applicable to the base device in Diamond. One skilled in the art could have applied the two-compartment sample testing device configuration in Sundvor in the same way to the base device in Diamond, yielding predictable results (MPEP 2143(I)(D)).
The limitation “configured to receive a test sample” 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, modified Diamond teaches a first compartment that is configured to perform the functional limitations above (the second chamber 130 in Fig. 1 of Sundvor receives a homogenized sample [0019]).
The limitation “configured to receive the test sample from the first compartment” is a functional recitation. In the instant case, modified Diamond teaches a second compartment that is configured to perform the functional limitations above (analysis chamber 140 is connected to second chamber 130 via outlet port 136 in Figs. 1 and 6A of Sundvor, such that the sample can flow between the compartments [0019, 0037]).
Regarding claim 20, modified Diamond teaches the sample testing device of Claim 19, and further teaches the device comprising a separator disposed between and separating the first compartment and the second compartment (a rod controlled by a spring-actuated valve 138 is disposed in outlet port 136 in Figs. 6A and 6B [0045 in Sundvor]).
The limitation “wherein the separator opens to transfer the test sample from the first compartment to the second compartment” 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, modified Diamond teaches a separator that is configured to perform the functional limitations above (the rod in valve 138 transitions between configurations 32 and 33 in Fig. 6B to dispense a sample dispersion into chamber 140 in Fig. 1 [0045 in Sundvor]).
Regarding claim 21, modified Diamond teaches the sample testing device of Claim 20, and further teaches the comprising a mechanical lock structure (controllable spring actuated valve 138 [0045 in Sundvor]).
The limitation “configured to lock and unlock a movement of the separator, wherein when the mechanical lock structure is unlocked, the separator opens to transfer the test sample from the first compartment to the second compartment” 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, modified Diamond teaches a mechanical lock structure that is configured to perform the functional limitations above (the spring-actuated valve 138 is controllably actuated to open [i.e., unlock] and close [i.e., lock] the rod that separates the two compartments to allow sample to flow [0045 in Sundvor]).
Regarding claim 23, modified Diamond teaches the sample testing device of Claim 19, and Diamond further teaches wherein the sensing element comprises a silicon sensing element (the sensing element is silicon 910 in Fig. 9 [0049]).
Regarding claim 24, modified Diamond teaches the sample testing device of Claim 19, and further teaches wherein the sample side has a plurality of electrodes exposed to the second compartment (a plurality of electrodes 950 on the sample side of silicon 910 in Fig. 9 are on the outer surface of chip 100 in Fig. 1 in Diamond, such that the electrodes are exposed to the compartment the chip is disposed in [0025, 0053 in Diamond]).
Regarding claim 25, modified Diamond teaches the sample testing device of Claim 24, and Diamond further teaches wherein the sensing element comprises a plurality of nanopores (nanopores 130 in Fig. 1 correspond to conical nanopores 130 in Fig. 5 and annotated Fig. 9 above), and wherein the plurality of electrodes are disposed about the plurality of nanopores (the planar projection of each electrode 950 in Fig. 9 encircles the plurality of nanopores in annotated Fig. 9).
Regarding claim 26, modified Diamond teaches the sample testing device of Claim 25, and Diamond further teaches wherein the plurality of nanopores of the sensing element includes a functionalized layer (the nanopores are functionalized with a layer of probe molecules 520 in Fig. 5A and 5B [0041]).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Diamond in view of Sundvor, as applied to claim 21 above, and further in view of Hu et al. (US 20190264161 A1).
Regarding claim 22, modified Diamond teaches the sample testing device of Claim 21, wherein the device further comprises a first compartment housing that at least partially defines the first compartment (as stated in the rejection of claim 19, the sample testing device includes a first compartment housing [driving element 120 acting as a plunger in Fig. 2A of Sundvor]).
Modified Diamond is silent to the limitation wherein the mechanical lock structure comprises a locking clip that locks the first compartment housing in position.
Hu teaches a sample testing device (pH sensor 100 in Fig. 3A [0028]) including a plunging element (plunger 134 in Fig. 3A [0028]), wherein a locking clip (slide lock 120 in Fig. 2) clips the plunger into an activated position to prevent unwanted movement of the plunger [0027].
Modified Diamond and Hu are both considered analogous to the claimed invention because they are in the same field of sample testing devices with plunging elements. 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 mechanical lock structure in modified Diamond by adding a locking clip that locks the first compartment housing (plunging driving element 120 in Sundvor) in position, as taught in Hu, since this would prevent unwanted movement of the housing [0027 in Hu]. Furthermore, Hu teaches the claimed improvement as a known technique that is applicable to the base device in modified Diamond. One skilled in the art could have applied the locking clip in Hu in the same way to the base device in modified Diamond, yielding predictable results (MPEP 2143(I)(D)).
The limitation “that locks a first compartment housing that at least partially defines the first compartment in position” 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, modified Diamond teaches a locking clip that is configured to perform the functional limitations above (the locking clip clips the plunger into an activated position to prevent unwanted movement of the plunger [0027 in Hu]).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Diamond in view of Sundvor, as applied to claim 19 above, and further in view of Kagenow (US 5114859 A).
Regarding claim 27, modified Diamond teaches the sample testing device of Claim 19, but is silent to the device further comprising an air vent channel in communication with the second compartment, wherein the air vent channel is configured to vent out air in the second compartment as the test sample flows into the second compartment.
Kagenow teaches a sample testing device (measuring device in Figs. 8-9 [col. 12, lines 25-28]) including a first compartment (rupturable pack 25 containing conditioning fluid 21 in Fig. 9 [col. 13, lines 4-7]) and a second compartment configured to receive a liquid from the first compartment (conditioning fluid chamber 15 in Fig. 8 receives conditioning fluid 21 from rupturable pack 25 [col. 13, lines 4-7]). The device further comprises an air vent channel in communication with the second compartment (air is released from conditioning fluid chamber 15 via vent 97 in Fig. 9 during the displacement of the conditioning fluid into chamber 15) to prevent pressure build up in the second compartment [col. 16, lines, 22-25].
Modified Diamond and Kagenow are both considered analogous to the claimed invention because they are in the same field of sample testing devices. 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 second compartment in modified Diamond by adding an air vent channel in communication with the second compartment, as taught in Kagenow, since this would prevent pressure build up in the second compartment [col. 16, lines, 22-25 in Kagenow]. Furthermore, Kagenow teaches the claimed improvement as a known technique that is applicable to the base device in modified Diamond. One skilled in the art could have applied the air vent channel in Kagenow in the same way to the base device in modified Diamond, yielding predictable results (MPEP 2143(I)(D)).
The limitation “wherein the air vent channel is configured to vent out air in the second compartment as the test sample flows into the second compartment” 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, modified Diamond teaches an air vent channel that is configured to perform the functional limitations above (air is released from conditioning fluid chamber 15 via vent 97 in Fig. 9 during the displacement of the conditioning fluid into chamber 15 [col. 16, lines, 22-25 in Kagenow]).
Response to Arguments
Applicant's arguments, see Remarks pgs. 5-10, filed 12/1/2025, with respect to the 35 U.S.C. § 102 and 35 U.S.C. § 103 rejections have been fully considered and are not persuasive.
Applicant’s Argument #1:
Applicant argues on pgs. 5-7 that Diamond does not teach all of the claimed limitations of claim 11 because silicon nitride layer 930 is not a substrate and silicon 910 is not a sensing element.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. There are no claimed structural elements of the substrate in claim 11 that would exclude silicon nitride layer 930 from the broadest reasonable interpretation of the term “substrate,” and the examiner maintains that the silicon nitride layer 930 reads on the claimed substrate. Similarly, there are no claimed structural elements of the sensing element in claim 11 that would exclude silicon 910 from the broadest reasonable interpretation of the term “sensing element.” The examiner maintains that silicon 910 reads on the claimed sensing element, as silicon 910 includes nanopores that capture the analyte with a layer of probe molecules 520 in Fig. 5A and 5B [0041 in Diamond].
Applicant’s Argument #2:
Applicant argues on pgs. 7-8 that Ackley does not teach all of the claimed limitations of claim 11 because planar support layers 40a, 40b, and 40c are not a sensing element with a buffer side opposite the sample side.
Examiner’s Response #2:
Applicant’s arguments have been fully considered, but are not persuasive. There are no claimed structural elements of the sensing element in claim 11 that would exclude planar support layers 40a, 40b, and 40c from the broadest reasonable interpretation of the term “sensing element,” and there are no claim structural elements that define the “buffer side” apart from being opposite a “sensing side.” The examiner maintains that planar support layers 40a, 40b, and 40c read on the claimed sensing element, as planar support layers 40a, 40b, and 40c form a structure that is integral to the overall sensor assembly (laminated structure 30 for biological diagnostics in Fig. 2 [col. 5, lines 15-27; col. 8, lines 1-4 in Ackley]) and has two opposing sides.
Applicant’s Argument #3:
Applicant argues on pgs. 7-9 that because claims 12-27 depend on independent claim 11, if independent claim 11 is allowable, dependent claims 12-27 are likewise allowable.
Examiner’s Response #3:
Based on the above responses #1-#3, applicant’s arguments regarding the amended claim 1 are moot in view of the new grounds of rejection.
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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/K.T./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795