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 .
Information Disclosure Statement
It is noted that an information disclosure statement (IDS) was not included in the electronic file wrapper of the instant application. Applicant is reminded of the duty to disclose information material to patentability as defined by 37 C.F.R. 1.56 (also see MPEP 2001).
Election/Restrictions
Applicant's election of Group I, Claims 1-7 and 15-20, without traverse in the reply filed on 10/10/2025 is acknowledged.
Claim Objection
Claims 2-3 and 20 are objected to because of the following informalities:
Claim 2: please amend “dielectrophoretic force” to – the dielectrophoretic force--; “said biomarker of interest” to -- said biomarkers of interest--.
Claim 3: please amend “said quantity of biomarkers of interest” to – said quantity of the biomarkers of interest--.
Claim 20: please amend “microfluidics channel” to – microfluidic[[s]] channel--.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 1, “means for receiving a biological sample onto an electrode array”, “means for applying a dielectrophoretic force through a plurality of electrodes of said electrode array”, and “means for determining a quantity of biomarkers of interest in said biological sample” are being interpreted under 35 U.S.C. 112(f) . Prong 1: means for, prong 2: receiving a biological sample onto an electrode array, applying a dielectrophoretic force through a plurality of electrodes of said electrode array, and determining a quantity of biomarkers of interest in said biological sample (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 1 invokes 112(f). The corresponding structures for performing the functions are described in the specification: wherein one or more biological samples (e.g., fluid) may be injected into the detection apparatus by one or more syringes 510 [para. 0067 in PGPub]; the EV-biosensor device may contain an RF AC waveform generator off-chip, wherein an RF AC waveform generator may apply one or more of a particular waveform across one or more electrodes (e.g., reference electrode 920, counter electrode 930, working electrode 940) [para. 0089 in PGPub]; wherein the labels may be chemically bonded to one or more sensors and ultimately digitally quantified [para. 0072 in PGPub]; and one or more sensors (e.g., sensor 570) [para. 0075 in PGPub].
Claim 15, “means for receiving a biological sample onto an electrode array”; “means for applying a dielectrophoretic force through a plurality of electrodes of said electrode array”; “means for filtering a first biomarker from a plurality of biomarkers of said biological sample”; “means for tagging said first biomarker with a label”; “means for detecting a quantity of said first biomarker”; and “means for displaying a result” are being interpreted under 35 U.S.C. 112(f) . Prong 1: means for, prong 2: receiving a biological sample onto an electrode array; applying a dielectrophoretic force through a plurality of electrodes of said electrode array; filtering a first biomarker from a plurality of biomarkers of said biological sample; tagging said first biomarker with a label; detecting a quantity of said first biomarker; and displaying a result (functional language), prong 3: sufficient structure for performing the function not recited. Therefore, claim 15 invokes 112(f). The corresponding structures for performing the functions are described in the specification: wherein one or more biological samples (e.g., fluid) may be injected into the detection apparatus by one or more syringes 510 [para. 0067 in PGPub]; the EV-biosensor device may contain an RF AC waveform generator off-chip, wherein an RF AC waveform generator may apply one or more of a particular waveform across one or more electrodes (e.g., reference electrode 920, counter electrode 930, working electrode 940) [para. 0089 in PGPub]; wherein the labels may be chemically bonded to one or more sensors and ultimately digitally quantified [para. 0072 in PGPub]; wherein biological sample may be passed to digital microfluidics (DMF) channel 630 until biological sample reaches one or more of a tagging chamber [para. 0075 in PGPub]; the detection apparatus may move fluid through one or more isolation and/or tagging chambers 560, wherein tagging of the fluid and/or isolation of the fluid may occur [para. 0070 in PGPub]; wherein the labels may be chemically bonded to one or more sensors and ultimately digitally quantified [para. 0072 in PGPub]; and one or more sensors (e.g., sensor 570) [para. 0075 in PGPub]; an I/O device may include monitor, touch screen [para. 0102 in PGPub].
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7 and 15-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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.
Regarding claim 5, claim 5 recites “said biomarker of interest”, which lacks antecedent basis. It is unclear if it refers to the biomarkers of interest or one of the biomarkers of interest. Note that “said biomarker of interest” in claim 5 is singular instead of plural. Thus, the scope of claim 5 is indefinite.
Regarding claim 6, claim 6 recites “said biomarker”, which lacks antecedent basis and it is unclear if it refers to the biomarkers of interest or a biomarker of the plurality of biomarkers or a biomarker of the biomarkers of interest. Therefore, the scope of claim 6 is indefinite. Claim 7 is further rejected by virtue of its dependence upon and because it fails to cure the deficiencies of indefinite claim 6.
Regarding claim 15, claim 15 recites “a plurality of biomarkers”, which is unclear if it is the same as or different than the extracellular vesicle-derived biomarkers. Therefore, the scope of claim 15 is indefinite. Claims 16-20 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 15.
Regarding claim 16, claim 16 recites “said quantity of biomarkers of interest”, which lacks antecedent basis. It is unclear if “biomarkers of interest” is the same as or different than the first biomarker, thus is unclear if said quantity of biomarkers of interest is the same as or different than the quantity of the first biomarker. Therefore, the scope of claim 16 is indefinite.
Regarding claim 18, claim 18 recites “said biomarker of interest”, which lacks antecedent basis. It is unclear if “said biomarker of interest” is the same as or different than the first biomarker. Therefore, the scope of claim 18 is indefinite.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 5-7, 15-16 and 18-20 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Heller et al. (US20140048417A1).
Regarding claim 1, Heller teaches a system (point of care [POC] diagnostic system that can be used to monitor and/or analyze blood for cancer cells, bacteria, virus, nanovesicles [drug delivery], nanoparticles, high molecular weight DNA nanoparticulates, cellular organelles, proteins, antibodies and antibody complexes, and a variety of other clinically relevant biomarkers of disease and metabolic state [para. 0016]) for obtaining a diagnosis from a plurality of biomarkers (can be used to monitor and/or analyze a variety of other clinically relevant biomarkers of disease [para. 0016]; thus the disclosed system is capable of performing the intended use of obtaining a diagnosis from a plurality of biomarkers), said system comprising:
means for receiving a biological sample onto an electrode array (a device with planar, robust, platinum electrode array structures and auxiliary electrodes, into which a complex biological sample [blood, plasma, serum] is directly applied [para. 0089]; Fig. 3 shows a planar platinum electrode array device 300 comprising a housing 302 through which a sample fluid can flow [para. 0090]);
means for applying a dielectrophoretic force through a plurality of electrodes of said electrode array (a device with planar, robust, platinum electrode array structures and auxiliary electrodes such that controlled AC signals from one or more function generators produce dielectrophoretic forces [para. 0089]; The planar electrode arrays 324 along the sides of the sample flow, when over-layered with nanoporous materials, can be used to generate DC electrophoretic forces as well as AC DEP [para. 0090]) ;
means for determining a quantity of biomarkers of interest in said biological sample (these novel DEP devices will allow a variety important disease biomarkers to be directly isolated, concentrated, and detected in blood, plasma, serum, and most other biological samples and buffers [para. 0068]. The fluorescent stained DNA/RNA can now be detected and quantified by using an epifluorescent detection system as shown in Fig.31 [para. 0074]).
Regarding claim 2, Heller teaches the system of claim 1, and “wherein a strength and direction of dielectrophoretic force is specific to said biomarker of interest in said biological 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, Heller teaches the means for applying a DEP force, that allows the separation of cells, nanoparticles, and biomarker entities to be carried out under higher conductance (>100 mS/m) ionic strength conditions, at lower AC (DEP) frequencies (<20 kHz), and at higher field strengths (>20 voltages pk-pk). More specifically, DEP separations can be carried out not only under higher ionic strength conditions, but also directly in complex biological samples including blood, plasma, serum, and undiluted buffers where now nanoscale (500 nm to 5 nm) analytes and entities can be isolated in the DEP high field regions, while the larger entities (cells, micron particles, etc.) can isolated in the DEP low-field regions between the electrodes [para. 0017]. By using both fluid and DC electrophoretic forces in opposite directions, DNA fragments and highly charged DNA nanoparticulates can be separated from cells and proteins in blood and other samples. In this way, using multiple AC frequencies, pulsed DC electrophoresis, and micro-electrophoresis, a more complete size separation of DNA nanoparticulates and DNA fragments can be accomplished [para. 0084]. Thus, a strength and direction of the generated dielectrophoretic force is specific to said biomarker of interest in said biological sample.
Regarding claim 5, Heller teaches the system of claim 1, wherein said biomarker of interest is an extracellular vesicle (monitor and/or analyze blood for cancer cells, nanovesicles, and a variety of other clinically relevant biomarkers of disease and metabolic state [para. 0016]).
Regarding claim 6, Heller teaches the system of claim 1, wherein said biomarker is tagged with a label (both the DEP separation and detection of labeled analytes using immunochemistry and ligand binding techniques that include fluorescent antibodies [para. 0069]).
Regarding claim 7, Heller teaches the system of claim 6, wherein said label is an antibody label or single-stranded DNA label (fluorescent antibodies [para. 0069]; in- situ labeling of the DNA [RNA] by addition of a DNA [RNA] specific fluorescent dye [para. 0074]).
Regarding claim 15, Heller teaches a system (sample-to-answer diagnostic system that can be used to monitor and/or analyze blood for cancer cells, bacteria, virus, nanovesicles, nanoparticles, high molecular weight DNA nanoparticulates, cellular organelles, proteins, antibodies and antibody complexes, and a variety of other clinically relevant biomarkers of disease and metabolic state [para. 0016]) for obtaining a diagnosis from extracellular vesicle-derived biomarkers (Fig.6 shows some of a wide variety of potential diagnostic and biomarker entities that would be found in a complex sample such as blood, which entities may include: red and white blood cells, bacteria, virus, nanovesicles, DNA/RNA nanoparticulates, an assortment of DNA and RNA fragments, and proteins [para. 0094]; thus the disclosed system is capable of performing the intended use of obtaining a diagnosis from extracellular vesicle-derived biomarkers), said system comprising:
means for receiving a biological sample onto an electrode array (a device with planar, robust, platinum electrode array structures and auxiliary electrodes, into which a complex biological sample [blood, plasma, serum] is directly applied [para. 0089]; Fig. 3 shows just one version of a planar platinum electrode array device 300 comprising a housing 302 through which a sample fluid can flow [para. 0090]);
means for applying a dielectrophoretic force through a plurality of electrodes of said electrode array (a device with planar, robust, platinum electrode array structures and auxiliary electrodes such that controlled AC signals from one or more function generators produce dielectrophoretic forces [para. 0089]; The planar electrode arrays 324 along the sides of the sample flow, when over-layered with nanoporous materials, can be used to generate DC electrophoretic forces as well as AC DEP [para. 0090 ]);
means for filtering a first biomarker from a plurality of biomarkers of said biological sample (Fig. 6 shows the planar platinum array electrodes 310 covered with an intermediate density nanopore layer 604, a low density nanopore layer 606, and a high density nanopore layer 608 directly over the AC electrodes 310 [para. 0094]; the different entities have been concentrated into their appropriate electrode array sections 402, 404, 406. In this example, DNA nanoparticulates and smaller DNA fragments are shown in the upper array section 402; bacteria, virus, and nanovesicles are shown in the middle array section 404; and cells and proteins are shown in the lower array section 408 [para. 0096]. while the more intermediate and lower molecular weight DNA fragments can be size-separated by microelectrophoresis within the nanopore layers 604, 606, 608 [para. 0100]. microfluidic channel(s) in the nanopore layers 604, 606 and 608 is deemed as the means for filtering);
means for tagging said first biomarker with a label (both the DEP separation and detection of labeled analytes using immunochemistry and ligand binding techniques that include fluorescent antibodies [para. 0069]);
means for detecting a quantity of said first biomarker (these novel DEP devices will allow a variety important disease biomarkers to be directly isolated, concentrated, and detected in blood, plasma, serum, and most other biological samples and buffers [para. 0068]. The fluorescent stained DNA/RNA can now be detected and quantified by using an epifluorescent detection system as shown in Fig.31 [para. 0074]); and
means for displaying a result (an associated epifluorescent microscope for monitoring and recording the separation experiments [para. 0107]; The experiments were visualized using a 10×PL Fluotar objective in a JenaLumar epifluorescent microscope. Both back lighted and the fluorescent images were captured using an Optronics 24-bit RGB CCD camera. The image data was processed using a Canopus ADVC-55 video capture card connected to a laptop computer using either Adobe Premiere Pro or Windows Movie Maker [para. 0117]).
Regarding claim 16, Heller teaches the system of claim 15, wherein an electro-chemical sensor determines said quantity of biomarkers of interest (other types of detection techniques that can be used for analysis include, but are not limited to, electrochemical methods for biosensing or nanosensing of the analytes once they have been isolated [para. 0070]).
Regarding claim 18, Heller teaches the system of claim 15, wherein said biomarker of interest is an extracellular vesicle (analyze blood for cancer cells, nanovesicles, and a variety of other clinically relevant biomarkers of disease and metabolic state [para. 0016]).
Regarding claim 19, Heller teaches the system of claim 15, wherein said label is an antibody label or single-stranded DNA label (fluorescent antibodies [para. 0069]; in- situ labeling of the DNA [RNA] by addition of a DNA [RNA] specific fluorescent dye [para. 0074]).
Regarding claim 20, Heller teaches the system of claim 15, wherein said filtering is accomplished via a microfluidic channel (Fig. 6 shows the planar platinum array electrodes 310 covered with an intermediate density nanopore layer 604, a low density nanopore layer 606, and a high density nanopore layer 608 directly over the AC electrodes 310 [para. 0094]; the different entities have been concentrated into their appropriate electrode array sections 402, 404, 406. In this example, DNA nanoparticulates and smaller DNA fragments are shown in the upper array section 402; bacteria, virus, and nanovesicles are shown in the middle array section 404; and cells and proteins are shown in the lower array section 408 [para. 0096]. while the more intermediate and lower molecular weight DNA fragments can be size-separated by microelectrophoresis within the nanopore layers 604, 606, 608 [para. 0100]. Thus, the filtering is accomplished via a microfluidic channel in the nanopore layers 604, 606 and 608).
Claims 1 and 3-4 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Nawarathna et al. (US20190064139A1).
Regarding claim 1, Nawarathna teaches a system (an apparatus of an integrated dielectrophoretic and surface plasmonic platform [abstract; para. 0015, 0054]) for obtaining a diagnosis from a plurality of biomarkers (It is a highly-sensitive, low-cost, high-throughput biosensor device to quantify low-levels of biomarkers in biological samples [para.0055 ]; thus the disclosed system is capable of performing the intended use of obtaining a diagnosis from a plurality of biomarkers), said system comprising:
means for receiving a biological sample onto an electrode array (a well for receiving biological samples [para.0017]; Samples were pipetted over the TIAM electrode array [para. 0141]);
means for applying a dielectrophoretic force through a plurality of electrodes of said electrode array (Dielectrophoretic capture of fluorescently labeled miRNA-DNA duplexes near electrodes. The miRNA mixture from step B is added to the PIAM. The DEP force is used to selectively localize and trap miRNA-DNA duplexes at hotspots [para. 0111]; Samples were pipetted over the TIAM electrode array and a 10 Vp-p, 1 MHz frequency sinusoidal signal was applied [t=0 second] using Tektronix AFG 3021B Single channel function generator [para. 0136]);
means for determining a quantity of biomarkers of interest in said biological sample (measuring the amount of labeled biomarker in the biological sample [para. 0020]; the PIDEs were imaged using a low-power fluorescent microscope and the fluorescence image was recorded [para.0089]; nano-scale plasmonic structures to quantify approximately 1 fM of fluorescent molecules in low conductivity buffers [para. 0016]).
Regarding claim 3, Nawarathna teaches the system of claim 1, wherein a digital sensor determines said quantity of biomarkers of interest (nano-scale plasmonic structures to quantify approximately 1 fM of fluorescent molecules in low conductivity buffers [para. 0016 ]; It is a highly-sensitive, low-cost, high-throughput biosensor device to quantify low-levels of biomarkers in biological samples. The underlying detection is based on integrated dielectrophoretic and plasmonic based fluorescence enhancement [para. 0055]).
Regarding claim 4, Nawarathna teaches the system of claim 1, wherein said plurality of electrodes are interdigitated (an interdigitated array of microelectrodes with nano-scale plasmonic structures to quantify approximately 1 fM of fluorescent molecules in low conductivity buffers [para. 0016]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Heller, as applied to claim 15 above, and in view of Nawarathna.
Regarding claim 17, Heller teaches the system of claim 15, and is silent to wherein said plurality of electrodes are interdigitated.
Nawarathna teaches a system (an apparatus of an integrated dielectrophoretic and surface plasmonic platform [abstract; para. 0015, 0054]) for obtaining a diagnosis from a plurality of biomarkers (It is a highly-sensitive, low-cost, high-throughput biosensor device to quantify low-levels of biomarkers in biological samples [para.0055 ]), said system comprising means for receiving a biological sample onto an electrode array (a well for receiving biological samples [para.0017]; Samples were pipetted over the TIAM electrode array [para. 0141]) and means for applying a dielectrophoretic force through a plurality of electrodes of said electrode array (Dielectrophoretic capture of fluorescently labeled miRNA-DNA duplexes near electrodes. The miRNA mixture from step B is added to the PIAM. The DEP force is used to selectively localize and trap miRNA-DNA duplexes at hotspots [para. 0111]; Samples were pipetted over the TIAM electrode array and a 10 Vp-p, 1 MHz frequency sinusoidal signal was applied (t=0 second) using Tektronix AFG 3021B Single channel function generator [para. 0136]), wherein the plurality of electrodes are interdigitated (an interdigitated array of microelectrodes [para. 0016]).
Heller and Nawarathna are considered analogous art to the claimed invention because they are in the same field of a system for a diagnosis of biomarkers using DEP to trap/isolate the analytes. 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 plurality of electrodes in Heller to interdigitated electrodes, as taught by Nawarathna, since Nawarathna teaches the interdigitated electrodes (IDEs) have been commonly used in the DEP experiments, and IDEs have been used in high-throughput manipulation of biological cells and molecules, and would provide a simple electrode structure that generates the extremely high electric field gradients needed for DEP-based cell/molecule manipulation [para. 0008].
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over respective claims 8, 8, 8, 16, and 16 of
co-pending Application No. 18/339,511 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of ‘511. Although the claims are not identical, they are not patentably distinct from each other because claim 8 of ‘511 discloses all limitations recited in instant claim 1 wherein a dielectrophoretic device recited in claim 8 of ‘511 corresponds to the system in instant claim 1.
Claim 2 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of ‘511. Although the claims are not identical, they are not patentably distinct from each other because claim 8 of ‘511 discloses all limitations recited in instant claim 2 wherein the one or more biomarkers of interest of the first biological sample recited in claim 8 of ‘511 corresponds to said biomarkers of interest in said biological sample in instant claim 2.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of ‘511. Although the claims are not identical, they are not patentably distinct from each other because claim 8 of ‘511 discloses all limitations recited in instant claim 3.
Claim 15 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of ‘511. Although the claims are not identical, they are not patentably distinct from each other because claim 16 of ‘511 discloses all limitations recited in instant claim 15 wherein a dielectrophoretic device recited in claim 16 of ‘511 corresponds to the system in instant claim 15.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of ‘511. Although the claims are not identical, they are not patentably distinct from each other because claim 16 of ‘511 discloses all limitations recited in instant claim 16.
Conclusion
The prior arts made of record and not relied upon are considered pertinent to applicant's disclosure: Wang et al. (US7081192B1) teaches a method for manipulating a moiety by DEP force generated by an interdigitated castellated electrode array. Arsene et al. (US20240044894A1) teaches a DEP-based extracellular vesicle characterization system. Chen et al. (Rapid and efficient isolation and detection of extracellular vesicles from plasma for ling cancer diagnosis, Lab on a chip, 2019, 19, 432) teaches DEP isolation and detection of EVs. Gustafson et al. (Automated fluorescence quantification of extracellular vesicles collected from blood plasma using dielectrophoresis, Lab on a chip, 2021, 21, 1318) teaches a DEP chip for quantify EVs.
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/SHIZHI QIAN/Examiner, Art Unit 1795