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 .
Election/Restrictions
Claims 1-8 and 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/16/2026.
Therefore, Applicant’s election without traverse of Group I, claims 9-17 in the reply filed on 02/16/2026 is acknowledged.
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)(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) 9-12 and 16-17 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Xia et al (“New-generation spacecraft water monitoring with flight-
ready solid state nanopores “), cited in the IDS.
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 9, Xia et al teaches a water monitoring system adapted to sense an organic analyte in water (see abstract), comprising: a fluidic cell that holds water for testing (see section II, C); a solid-state nanopore chip (illustrated in Figure 1 and described in section II, B) having at least one nanopore of less than 5 nm diameter disposed in the fluidic cell for testing the water for the organic analyte, the organic analyte having a diameter of approximately 1 nm or less (wherein pores of ~0.5 to 1.2 nm may be used for very small analytes, see page 5); and a nanopore reader that measures concentration of the organic analyte as the water passes through the at least one nanopore of the solid-state nanopore chip (see Figures 1 and 6 and abstract).
Regarding Claim 10, Xia et al teaches that the fluidic cell is disposed on a spacecraft (such as the ISS) (See abstract).
Regarding Claim 11, Xia et al teaches that the solid-state nanopore chip comprises at least one silicon nitride (SiNx) nanopore having a thickness of approximately 5 nm at the at least one SiNx nanopore (see Figure 1 and abstract).
Regarding Claim 12, Xia et al teaches that the nanopore has a diameter of ~ 2 nm (see abstract).
Regarding Claim 16, Xia et al teaches that the nanopore reader records translocation events of organic analytes one at a time as the organic analytes translocate through the at least one nanopore (see Section II, C and abstract).
Regarding Claim 17, Xia et al teaches wherein the solid-state nanopore chip is fabricated from a fused silicon oxide glass wafer coated on a first side with a low stress SiNx and poly-silicon (see Section II, B). In addition, Xia et al teaches that “Pores were drilled with a 200 keV focused electron beam in a JEOL 2010F transmission electron
microscope (TEM, JEOL USA Inc., USA)” (see section II, B).
Furthermore, claim 17 is being interpreted as a product by process claimed where all that is required is the final product (i.e. the solid-state nanopore chip constructed from silicon oxide glass wafer, coated with SiNx and poly-silicon)(as described in section II, B of Xia et al).
Claim(s) 9, 11-12 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niedzwiecki et al (“Detection of single-analyte and environmental
samples with silicon nitride nanopores: Antarctic Dirt Particulates and DNA in Artificial Seawater”), cited in the IDS.
Regarding Claim 9, Niedzwiecki et al teaches a water monitoring system adapted to sense an organic analyte in water (see abstract), comprising: a fluidic cell that holds water for testing (see section 1-2 and Figure 1); a solid-state nanopore chip (illustrated in Figure 1 and described in section II, B) having at least one nanopore of less than 5 nm diameter disposed in the fluidic cell (illustrated in Figure 1 and described in section 2.2 for testing the water for the organic analyte (wherein the organic analyte is DNA, BSA, microRNA, TAT and Poly-D-lys-hydrobromide, the organic analyte having a diameter of approximately 1 nm or less (see page 14); and a nanopore reader that measures concentration of the organic analyte as the water passes through the at least one nanopore of the solid-state nanopore chip (see Introduction section and Figure 3).
Regarding Claim 11, Niedzwiecki et al teaches that the solid-state nanopore chip comprises at least one silicon nitride (SiNx) nanopore having a thickness of approximately 5 nm at the at least one SiNx nanopore (see abstract and section 2.2).
Regarding Claim 12, Niedzwiecki et al teaches that the nanopore has a diameter of ~ 2 nm (see section 2.2).
Regarding Claim 16, Niedzwiecki et al teaches that the nanopore reader records translocation events of organic analytes one at a time as the organic analytes translocate through the at least one nanopore (see abstract and section 2).
Regarding Claim 17, Niedzwiecki et al teaches wherein the solid-state nanopore chip is fabricated from a fused silicon oxide glass wafer coated on a first side with a low stress SiNx and poly-silicon (see Section 2.1). In addition, Niedzwiecki et al teaches “Membrane thinning to below 10 nm can be further performed by reactive ion etching to reduce the pore resistance. Replacing the typical silicon substrates by fused silica (glass), lowered the chip capacitance from the typical - 10-50 pF to the sub-pF to single pF range. (see Section 2.1).
Furthermore, claim 17 is being interpreted as a product by process claimed where all that is required is the final product (i.e. the solid-state nanopore chip constructed from silicon oxide glass wafer, coated with SiNx and poly-silicon).
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.
Claim(s) 9, 11-12 and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Predki et al (US PGPub 2019/0136307) in view of Haick et al (WO 2022/137232).
Regarding Claims 9 and 15, Predki et al teaches
a fluidic cell (i.e. nanopore-based cell 4800) that holds water for testing (see Figure 48 and [0188]);
a solid-state nanopore chip having at least one nanopore of less than 5 nm diameter (see abstract, [0012]-[0015] and [0144], which discloses that the nanopores are 2-5 nm in diameter, such that DNA may pass through) disposed in the fluidic cell for testing the water for the organic analyte (see [0007], [0054] and [0740]), and a nanopore reader that measures concentration (by measuring capacitive or impedance variance) of the organic analyte as the water passes through the at least one nanopore of the solid-state nanopore chip (see abstract, [0010] and [0206]).
Predki et al does not explicitly disclose that the organic analyte tested has a diameter of less than 1 nm (and comprises at least one of DEP) or that the nanopore chip/fluidic cell system is adapted to sense an organic analyte in water.
However, in the analogous art of methods of diagnosing cancer in a test subject, using conductive nanostructures, Haick et al teaches methods of diagnosing cancer in a test subject, comprising exposing an array of chemically sensitive sensors comprising a material selected from the group consisting of conductive nanostructures coated with an organic coating, a conducting polymer and a conductive polymer composite, to a blood sample and a urine sample obtained from the test subject, and analyzing output signals of the chemically sensitive sensors upon exposure of the array to the blood sample and the urine sample. The array of the chemically sensitive sensors can be a part of a portable medical device (see abstract). In addition, Haick et al teaches that the analyte being tested is DEP (see page 21, lines 4-21).
Accordingly, it would have been obvious to one of ordinary skill in the art to utilize the system of Predki et al to detect/test for DEP (as taught by Haick et al) for the benefit of enabling the device to utilized in methods of diagnosing various types of cancer.
In addition, while the combination of Predki et al and Haick et al does not explicitly disclose that the organic analyte has a diameter of 1 nm or less it is noted that based upon the dimensions of the nanopores disclosed by Predki (i.e. 2-5 nm diameter nanopores, disclosed in [0144] of Predki et al), it would have been obvious to one of ordinary skill in the art to have the organic analyte diameter be less than 1 nm for the benefit of ensuring the analyte may effectively pass through the nanopore for future testing.
Furthermore, examiner Wecker notes that claim 1 is an apparatus claim and notes that while features of an apparatus may be recited either structurally or functionally, [A]pparatus claims cover what a device is, not what a device does , i.e. water monitoring. See MPEP 2114.
In addition, it is noted that "[i]nclusion of the material or article worked upon (such as the organic analyte claimed) by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
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See MPEP 2115.
Regarding Claim 11, Predki et al teaches that the solid-state nanopore chip comprises at least one silicon nitride (SiNx) nanopore having a thickness of approximately 5 nm at the at least one SiNx nanopore (see [0141]-[0145]).
Regarding Claim 12, Predki et al teaches that the at least one nanopore has a diameter of approximately 2 nm (see [0144]).
Furthermore, that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device (such as the dimensions of the nanopores) and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04.
Regarding Claim 16, Predki et al teaches that the nanopore reader records translocation events of organic analytes one at a time as the organic analytes translocate through the at least one nanopore (See [0556]).
Regarding Claim 17, Predki et al teaches that the solid-state nanopore chip is fabricated from a fused silicon oxide glass wafer coated on a first side with a low stress SiNx and poly-silicon (see [0467]).
Furthermore, claim 17 is being interpreted as a product by process claimed where all that is required is the final product (i.e. the solid-state nanopore chip constructed from silicon oxide glass wafer, coated with SiNx and poly-silicon).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Predki et al as applied to claim 9 above, and further in view of Yun et al (US PGPub 2009/0242416).
Regarding Claim 10, Predki et al does not teach that the fluidic cell is disposed on a spacecraft.
However, in the analogous art of nanowire sensors and sensor arrays, Yun et al teaches a novel system of storing information using a charged polymer, e.g., DNA, the monomers of which correspond to a machine-readable code, e.g., a binary code, and which can be synthesized and/or read using a novel nanochip device comprising nanopores; novel methods and devices for synthesizing oligonucleotides in a nanochip format; novel methods for synthesizing DNA in the 3′ to 5′ direction using topoisomerase (see abstract). Furthermore, Yun et al teaches that space missions, including human exploration, require the development of biochemical sensors to find evidence of life on Mars, for diagnosis and treatment of astronauts' emerging disease, and for environmental control and safety monitoring in the spacecraft (see [0097]). It would have been obvious to one of ordinary skill in the art to dispose the nanopore array in spacecraft for the benefit of safely monitoring diseases and providing environmental control in spacecraft systems.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Predki et al as applied to claim 12 above, and further in view of Leburton et al (US PGPub 2009/0084688).
Regarding Claims 13-14, Predki et al teaches nanopores having a diameter of 2-5 nm.
However, Predki does not explicitly disclose that the diameter of the nanopores is ~ 1.9 (claim 13) or ~ 1.5 (claim 14).
However, in the analogous art of solid state devices, Lemburton et al teaches a nanopore-membrane structure geometry is shown schematically in FIGS. 1A-1B and consists of two 12 nm Si layers of different doping: the top layer is n-doped (typically N.sub.d.sup.n=2.times.10.sup.20 cm.sup.-3) and the bottom layer is p-doped (typically N.sub.d.sup.n=2.times.10.sup.20 cm.sup.-3). The nanopore in this solid-state membrane has a double-conical shape with a 1 nm diameter in the narrowest region and 6 nm diameter opening on each side of the pore (see [0030]). Furthermore, Lemburton et al teaches that nanopores may have a diameter below 2 nm (see [0049]).
Accordingly, it would have been obvious to modify the system of Predki et al to have the nanopores have a diameter of ~ 1.5 or 1.9 (as taught by Lemburton et al ) for the benefit of
Furthermore, that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device (such as the dimensions of the nanopores) and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Xia et al as applied to claim 12 above, and further in view of Leburton et al (US PGPub 2009/0084688).
Regarding Claims 13-14, Xia et al teaches that the nanopore has a diameter of 1.8 nm (see Section (III, A).
However, in the analogous art of solid state devices, Lemburton et al teaches a nanopore-membrane structure geometry is shown schematically in FIGS. 1A-1B and consists of two 12 nm Si layers of different doping: the top layer is n-doped (typically N.sub.d.sup.n=2.times.10.sup.20 cm.sup.-3) and the bottom layer is p-doped (typically N.sub.d.sup.n=2.times.10.sup.20 cm.sup.-3). The nanopore in this solid-state membrane has a double-conical shape with a 1 nm diameter in the narrowest region and 6 nm diameter opening on each side of the pore (see [0030]). Furthermore, Lemburton et al teaches that nanopores may have a diameter below 2 nm (see [0049]).
Accordingly, it would have been obvious to modify the system of Xia et al to have the nanopores have a diameter of ~ 1.5 or 1.9 (as taught by Lemburton et al ) for the benefit of
Furthermore, that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device (such as the dimensions of the nanopores) and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04.
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Niedzwiecki et al as applied to claim 12 above, and further in view of Leburton et al (US PGPub 2009/0084688).
Regarding Claims 13-14, Niedzwiecki et al et al teaches that the nanopore has a diameter of ~1.6 – 20 nm (see abstract). In addition, section 2.2 cites a diameter of 1.8 nm (see section 2.2 and Figure 27).
However, in the analogous art of solid state devices, Leburton et al teaches a nanopore-membrane structure geometry is shown schematically in FIGS. 1A-1B and consists of two 12 nm Si layers of different doping: the top layer is n-doped (typically N.sub.d.sup.n=2.times.10.sup.20 cm.sup.-3) and the bottom layer is p-doped (typically N.sub.d.sup.n=2.times.10.sup.20 cm.sup.-3). The nanopore in this solid-state membrane has a double-conical shape with a 1 nm diameter in the narrowest region and 6 nm diameter opening on each side of the pore (see [0030]). Furthermore, Lemburton et al teaches that nanopores may have a diameter below 2 nm (see [0049]).
Accordingly, it would have been obvious to modify the system of Xia et al to have the nanopores have a diameter of ~ 1.5 or 1.9 (as taught by Leburton et al ) for the benefit of
Furthermore, that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device (such as the dimensions of the nanopores) and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04.
Conclusion
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/JENNIFER WECKER/ Primary Examiner, Art Unit 1797