Detailed Action
This is a Non-Final Office action based on application 17/438,000 filed on 10 September 2021. The application is a 371 of PCT/ US2020 /022544, with priority to US provisional applications 62/817,821 and 62/817,825 filed 13 March 2019.
Claims 1-18 are pending, claims 3 and 14-18 are withdrawn, and claims 1-2 and 4-13 have been fully considered.
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
Applicant's election without traverse of claims 1-2 and 4-13, in the reply filed on September 23, 2025, is acknowledged. Claims 3 and 14-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim 9 recites “wherein the sensor is configured to measure the conductivity and/or the resistance of an analyte attached to the sensor”. The only mention of a resistance or conductivity measurement in the instant specification is at pg 5-6, where Applicant discloses a field-effect transistor (FET) sensor that measures the resistance of a gated semiconductor channel and senses the binding of an analyte to the sensor from changes in the resistance of the semiconductor channel. Applicant’s specification contains no disclosure of a device that measures the resistance or conductivity of the analyte itself.
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 7-9 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 7, 8, and 9 each recite the limitation “the sensor”, however, there is insufficient antecedent basis for this limitation in any of these claims.
For the purpose of treatment against the art in this action, claims 7, 8, and 9 are each interpreted as depending from claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 10-11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smolko et al (US 6,284,117 B1).
Regarding claim 1, Smolko teaches a system for removing a plurality of ions from a sample (abstract, “apparatus and method for desalting”; figure 3), the system comprising: a first electrode and second electrode (figure 3, electrodes 22; col 3 ln 36-55, an electric potential may be applied between the two electrodes); a first porous material adjacent to at least a portion of the first electrode, and a second porous material adjacent to at least a portion of the second electrode (figure 3, a first portion of ion exchange resin material 11 is disposed adjacent one of the two electrodes 22, and a second portion of IER material 11 is disposed adjacent the other electrode; col 3 ln 34-47, the ion exchange resin is in the form of a water-permeable bed of granulated or powdered resin material, i.e. a porous material).
Regarding claim 10, Smolko teaches the system of claim 1, wherein the first porous material and the second porous material comprises a resin (col 4 ln 10, the porous material 11 is ion exchange resin; col 5 ln 25-35).
Regarding claim 11, Smolko teaches the system of claim 1, wherein the first porous material and the second porous material comprises a size exclusion material (figure 3, the porous material also comprises membrane material 10; col 5 ln 19-25, the membrane is a size exclusion membrane).
Regarding claim 13, Smolko teaches the system of claim 1 wherein the porous material comprises a nanoporous material (col 5 ln 19-20, porous material includes a size exclusion membrane with a pore size cutoff of from 1 to 500 kDa).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2 and 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Murray et al (US 2009/0142825 A1) in view of Smolko.
Regarding claim 2, Murray teaches a system for removing a plurality of ions from a sample (para [0007], “a composite detection device having in-line desalting”), the system comprising:
a substrate (figure 1, semiconductor substrate 34 having patterned insulator later 32 formed on it; para [0030]);
a desalting chamber proximate the substrate (figure 1, desalting unit comprises salt reservoir 37, membrane 24; para [0030], membrane 24 is disposed on the substrate);
a microfluidic channel (figure 1, channel 20); and
a sensing chamber proximate the substrate, the sensing chamber comprising at least one sensor (figure 1, sensor 28; para [0030], sensor 28 is disposed on the substrate),
wherein the desalting chamber and the sensing chamber are in fluidic communication via the microfluidic channel (as shown in figure 1).
Murray’s desalting chamber comprises a porous material (figure 1 membrane 24) and a reservoir of low-ionic strength liquid (figure 1 reservoir 37), and operates by the passive diffusion of ions from the more concentrated analyte stream to the less concentrated salt sink stream (para [0026]-[0027], [0032]).
Murray does not teach a desalting chamber comprising a first electrode, a first porous material adjacent to at least a portion of the first electrode, a second electrode in electrical communication with the first electrode, and a second porous material adjacent to at least a portion of the second electrode.
Smolko teaches a system for removing a plurality of ions from a sample (abstract, “apparatus and method for desalting”; figure 3), the system comprising: a desalting chamber (figure 3), a microfluidic channel (col 5 ln 60-61, “microchannels”); and a sensing chamber (col 5 ln 56-60, “an electronically addressable microarray”), the sensing chamber comprising at least one sensor (col 5 ln 57-58, “performing assays on ... microarray”; col 6 ln 33-38, an exemplary sensor is a microelectronic assay that binds nucleic acid analyte and detects via a fluorescent label), wherein the desalting chamber and the sensing chamber are in fluidic communication via the microfluidic channel (col 5 ln 60-62, “microchannels ... connect the desalting apparatus to the microarray”). In one embodiment (figure 1, col 4 ln 7-12), Smolko’s desalting chamber comprises porous material (figure 1, ion exchange resin 11; col 3 ln 34-47, the ion exchange resin is a water-permeable bed of granulated or powdered resin, i.e. a porous material) and a low ionic stream liquid stream (figure 1, col 4 ln 7-12, “ports 12 and 13 for channeling low ionic strength buffer or water”) and operates by the passive diffusion of ions from the analyte stream into the porous material. In a second embodiment (figure 3, col 4 ln 22-29, col 5 ln 36-55), Smolko’s desalting chamber comprises a first electrode and second electrode (figure 3, electrodes 22; col 3 ln 36-55, an electric potential may be applied between the two electrodes), a first porous material adjacent to at least a portion of the first electrode, and a second porous material adjacent to at least a portion of the second electrode (figure 3, a first portion of ion exchange resin material 11 is disposed adjacent one of the two electrodes 22, and a second portion of material 11 is disposed adjacent the other electrode; col 3 ln 34-47, the IER material is a porous bed of granulated or powdered resin). Smolko teaches that the second of these embodiments adds electrically-driven deionization on top of the passive deionization of the first embodiment (col 4 ln 26-27), with the result that samples are desalted quickly and thoroughly (col 5 ln 45-55).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the desalting chamber of Murray’s system, by incorporating first and second electrodes having first and second porous materials adjacent thereto in order to achieve quicker and more effective desalting of analyte solutions, as taught by Smolko. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. The incorporation of a predictable improvement into a known base invention, based on a finding that the prior art contained a comparable device that has been improved in the same way, is prima facie obvious as being part of the ordinary capabilities of one skilled in the art (MPEP 2143(C)).
Regarding claim 4, Murray and Smolko render obvious the system of claim 2, and Murray teaches that the desalting chamber is positioned adjacent the substrate ((figure 1, para [0030], the desalting chamber (comprised of membrane 24 and reservoir 37) is adjacent the substrate (comprised of semiconductor layer 34 and insulator layer 32)).
Regarding claim 5, Murray and Smolko render obvious the system of claim 2, and Murray teaches that the desalting chamber and the sensing chamber are positioned adjacent the substrate (figure 1, para [0030], the desalting chamber (comprised of membrane 24 and reservoir 37) and the sensing chamber (comprising sensor 28) are adjacent the substrate (comprised of semiconductor layer 34 and insulator layer 32)).
Regarding claim 6, Murray and Smolko render obvious the system of claim 2, and Murray teaches that the sensing chamber is positioned adjacent to a second substrate (figure 1, upper wall 14 of the microfluidic device 12 reasonably reads as a second substrate; para [0028], wall 14 may be a substrate made of glass, silicon, or polymer).
Regarding claim 7, Murray and Smolko render the system of claim 2 obvious, and Murray further teaches the sensor comprises a field effect biosensor (para [0006], “desalting for nano-FET biosensor”; para [0029], the sensor operates by detecting changes in the conductance of a channel upon binding of analyte to the channel surface).
Regarding claim 8, Murray and Smolko render the system of claim 2 obvious, and Murray further teaches the sensor comprises a silicon nanowire and at least one antibody (para [0020], the sensor comprises a semiconductor nanowire; para [0021], the semiconductor from which it is made is silicon; para [0029], the nanowire is functionalized with a species that binds a molecule of interest; para [0023], the functional species may be an antibody).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Murray and Smolko as applied to claim 2 above, and further in view of Sergeyeva et al (“Conductimetric sensor for atrazine detection based on molecularly imprinted polymer membranes”, The Analyst, 124, 331-334 (1999)).
Regarding claim 9, Murray and Smolko render obvious the system of claim 1. However, Murray’s sensor is configured to measure the conductivity and/or resistance of the conducting channel of a FET, and detect changes in the channel resistance when an analyte is bound to the channel surface. Murray does not teach a sensor that is configured to measure the conductivity and/or the resistance of the analyte itself.
Sergeyeva discloses a conductimetric sensing system comprised of two electrodes (pg 332 figure 1, “Pt electrodes”) and a membrane disposed therebetween (pg 332 figure 1, “membrane”). The membrane is configured with molecularly imprinted pores, formed by casting the polymer membrane around an analyte molecule that serves as template and then removing the template. The membrane binds the templated analyte molecule with high selectivity, and the presence of the analyte is detected from the change in the through-membrane resistance when the analyte is present – that is, the measured quantity directly corresponds to the resistance of an analyte attached to the sensor. Sergeyeva teaches that this sensor configuration is useful because it can achieve nanomolar sensitivity (pg 332 figure 2), with high specificity for the particular analyte of interest (pg 334 figure 6).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the sensing platform of Murray and Smolko by using, as the sensing element, the sensor configuration of Sergeyeva, which is configured to measure the resistance of an analyte attached to the sensor, based on Sergeyeva’s teaching that this sensor configuration has high sensitivity and specificity. Furthermore the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results [MPEP 2143(A)].
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Smolko as applied to claim 1 above, in view of Sun (CN 107473397 A; hereinafter, citations to Sun are taken from a machine translation of the document into English).
Regarding claim 12, Smolko teaches the system of claim 1. Smolko does not teach that the porous material comprises dangling bonds configured to associate with at least a portion of the plurality of ion.
Sun teaches a water purifying composition for use in water purification, comprising as one of its ingredients, iron oxide sorbent nanoparticles (translated pg 5 paragraph 4; translated pg 6 paragraph 2). Sun teaches that the iron oxide particles comprise dangling bonds configured to associate with ions in the water being treated, and that such dangling bonds improve the sorbent’ adsorption capacity toward metal contaminant species (translation pg 6 paragraph 2, “undersaturated dangling bonds in surface atom can improve surface-active site, make it have very strong energy of adsorption Power, compared to traditional flocculant, it can the effective impurity such as the suspension in absorption effluent, metal, metal oxide”; translated pg 10 paragraph 2).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Smolko by including, in the porous material, sorbent material comprising dangling bonds configured to associate with ions in the water as taught by Sun, in order to improve the effectiveness of Smolko’s desalting apparatus for removal of metal species in the water. The selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art [MPEP § 2144.07].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bashir et al (US 10,527,579 B2) discloses a microfluidic FET biosensor which includes, integrated on the same substrate as the sensing device, a desalting device comprising capacitive deionization electrodes.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached at (571) 272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW KOLTONOW/Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795