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 Group I in the reply filed on 11/17/25 is acknowledged.
Claim 43-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
[Examiner notes that while Applicant’s response of 11/17/25 states that claims 43-52 are non-elected and withdrawn, these claims do not appear on the pages reciting the claims. Therefore, it is not clear whether or not claims 43-52 are withdrawn but still pending, or whether claims 43-52 have been canceled. Clarification is required.]
Claim Objections
Claim 33 is objected to because of the following informalities: in line 11 of subsection (e), “resent” should be –present--. Appropriate correction is required.
Also, claim 33 includes subsection “d.”, but this subsection is not an element that is an element that is part of the subsystem, like subsections a, b, c, and e. Therefore, the original “d.” should be deleted, and the original “e” should be replaced by –d--.
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 33-42 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.
Claim 33 recites: “A system for use in concurrently detecting and quantifying biological analytes wherein the system includes at. least one subsystem, which subsystem upon being mixed together forms analyte-linked particle complexes, wherein the subsystem comprises: a….b…c…d…e…” (Emphasis added).
Examiner notes that claim 33 is directed to a system. However, it is not clear as to whether or not the claim is reciting open language (such as “comprising”) as opposed to closed language (such as “consisting of”. That is, it is not clear whether or the not the system can include elements other than the recited subsystem.
Claim 34 recites the limitation "the preceding group" in line 8. There is insufficient antecedent basis for this limitation in the claim. It is unclear if “the preceding group” refers to the capture particles or the detection particles or both.
Claim 37 recites “an average 10 number of molecular probes” in line 2. It is unclear as to what Applicant means by “an average 10 number”. For examination purposes, this limitation is interpreted to mean “about 10”.
Claim 38 recites “at least one 15 binding affinity within the analyte-linked particle complexes having a coupling reagent included therein further comprises a modulating agent” in lines 1-5. It is unclear as to what Applicant means by these limitations. It is unclear as to what is meant by “at least one 15 binding affinity”. It is also unclear as to how an affinity has a coupling reagent.
Claim 41 recites “simultaneously and discretely differentiating and enumerating” in lines 2-3. The claim lacks sufficient antecedent basis for this limitation. While claim 33 does recite in the preamble a “system for use in concurrently detecting and quantifying”, and in subsection e. “discretely differentiating and enumerating the analyte-linked particle complexes”, the claim lacks sufficient antecedent basis for simultaneously (or concurrently) differentiating.
It is also not clear in claim 41 if the claim is reciting simultaneously differentiating and enumerating, or if the claim is reciting simultaneously differentiating various complexes and simultaneously enumerating the various complexes. For examination purposes, any of these interpretations may be considered [until the claim is clarified].
The remaining claims are rejected for being dependent on claim 33 (and thus reciting the same limitations as claim 33) without clarifying the vagueness mentioned above.
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) 33-36 and 39-40 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by US 20180372601 (hereinafter “Su”) [cited in the International Search Report mailed January 27, 2021].
Claim 33 recites:
“[a] system for use in concurrently detecting and quantifying biological analytes
wherein the system includes at least one subsystem, which subsystem upon being mixed together forms analyte-linked particle complexes,
wherein the subsystem comprises:
a. a set of target biological analytes with each target biological analyte being selected from a group consisting of: I. single component having multiple binding sites; and ii. multiple components, each component having at least one binding site;
b. a set of capture particles that are labeled by a unique physical characteristic, each capture particle being capable of binding to a first binding site of the selected target biological analyte;
and c. a set of detection particles that are labeled by a unique physical characteristic, each detection particle being capable of binding to a second binding site of the target biological analyte that differs from the first binding site of the target biological analyte;
whereby mixing the set of target biological analytes both with the set of capture particles and with the set of detection particles:
d. forms analyte-linked particle complexes having capture particles and detection particles bound respectively to binding sites of the target biological analytes both: I. for the capture particles; and ii. for the detection particles; and
e. the analyte-linked particle complexes thus formed linking together at least one capture particle, at least one target biological analyte and at leastone detection particle;the analyte-linked particle complexes thus formed permitting detection and quantification of the target biological analytes by discretely differentiating and enumerating the analyte-linked particle complexes that are present in a mixture that includes unbound capture and detection particles.”
Regarding claim 33, Su discloses the limitations of this claim as follows.
Su discloses: a system for use in concurrently detecting and quantifying biological analytes.
See paragraph 0019 of Su disclosing the following.
“The device comprises a fluidic network and an integrated circuitry component, functionally coupled to a magnetic microcoil array, a detection element, a circuit board, and optionally, a vibration element. Specifically, the fluidic network comprises a plurality of fluidic zones, where each zone is connected to the adjacent zone by a diffusion barrier. Typically one or more of the fluidic zones contains a magnetic particle and/or a signal particle. A sample suspected of containing an analyte is introduced into a fluidic zone. The analyte interacts with a magnetic particle and/or a signal particle to form a binding complex. The magnetic microcoil array is activated to generate a magnetic field across at least portion of a fluidic zone to separate magnetic particles and binding complexes from uncomplexed signal particles and to move the binding complexes to a fluidic zone where it can be detected by the detection element.” Para. 0019 (emphasis added).
“The arrays can be used to measure the expression levels of large numbers, e.g., tens, thousands or millions, of reactions or combinations simultaneously.” Para. 0077 (emphasis added).
“In another embodiment, one or more fluidic zones also comprise a signal affinity complex. The analyte is combined with the magnetic affinity complex and the signal affinity complex, either simultaneously or sequentially, where the magnetic affinity complex and the signal affinity complex bind to the analyte to form a sandwich binding complex.” Para. 0151 (emphasis added).
Further, as to claim 33, Su discloses that the system includes at least one subsystem, which subsystem upon being mixed together forms analyte-linked particle complexes,
wherein the subsystem comprises:
a set of target biological analytes with each target biological analyte being selected from a group consisting of: I. single component having multiple binding sites; and ii. multiple components, each component having at least one binding site
[see para. 0019 disclosing that the analyte interacts with a magnetic particle and/or a signal particle to form a binding complex];
a set of capture particles that are labeled by a unique physical characteristic, each capture particle being capable of binding to a first binding site of the selected target biological analyte
[see para. 0026 disclosing “[a]s used herein, a “magnetic affinity complex” comprises a magnetic particle functionally coupled to an affinity agent. The term “affinity agent” generally refers to a molecule that binds to an analyte for the detection and/or analysis of the analyte and is described in more detail below. Non-limiting examples of affinity agents include example of affinity agents including antibodies, lectins, streptavidin, oligonucleotides, peptides, and oligosaccharides. It can be coupled to the magnetic particle using a functionalized polymer, for example”];
and c. a set of detection particles that are labeled by a unique physical characteristic, each detection particle being capable of binding to a second binding site of the target biological analyte that differs from the first binding site of the target biological analyte
[see para. 0029 disclosing: [a] “signal particle” is a nanoparticle that is detectable by the detection element of the device, and thus encompasses signal affinity complexes, signal analyte complexes, and coded magnetic signal affinity complexes, among others. In certain embodiments the signal particle is a surface-enhanced Raman spectroscopy (SERS)-active nanoparticle, a fluorescent nanoparticle, a nanoparticle coupled to a surface-enhanced fluorescent tag, a nanoparticle containing contrast reagents, or a core nanoparticle covalently coupled to a catalytic element”]
[see para. 0030 disclosing: “[a] “signal affinity complex” comprises a signal particle functionally coupled to an affinity agent. A “signal analyte complex” refers to a signal particle functionally coupled to an analyte. An “analyte” refers to a molecule or biological cell of interest that is to be analyzed or detected using the devices…”];
whereby mixing the set of target biological analytes both with the set of capture particles and with the set of detection particles:
d. forms analyte-linked particle complexes having capture particles and detection particles bound respectively to binding sites of the target biological analytes both: I. for the capture particles; and ii. for the detection particles
[see para. 0019 disclosing that the analyte interacts with a magnetic particle and/or a signal particle to form a binding complex]
[see para. 0033 disclosing: “The analyte interacts with the magnetic particle and/or signal particle to form a binding complex, which includes any combination of the above-described magnetic particles and signal particles. Binding complexes include for example, sandwich binding complexes, magnetic binding complexes, signal binding complexes, competitive binding complexes, coded magnetic binding complexes, and coded magnetic signal binding complexes”]
[see para. 0034 disclosing: “A “sandwich binding complex” comprises a magnetic affinity complex, a signal affinity complex, and analyte. For example, a sample suspected of comprising an analyte is introduced into the sample zone of the fluidic device. The analyte interacts sequentially or simultaneously with a magnetic affinity complex and a signal affinity complex to form a sandwich binding complex. Typically the affinity agent coupled to the magnetic particle is different than the affinity agent coupled to the signal particle, although both are complementary to the analyte. The microcoil array is activated to move the sandwich binding complex to the detection zone. Uncomplexed signal particles are left behind without being transported. The signal detected front the sandwich binding complex indicates the presence of the analyte. Typically this method is useful for determining the presence of proteins including peptides, antibodies and autoantibodies) or nucleic acids.” (emphasis added; Examiner notes that it is understood that the magnetic particle and affinity agents are both coupled to the analyte at different binding sites)]
[see para. 0151 disclosing: “The analyte is combined with the magnetic affinity complex and the signal affinity complex, either simultaneously or sequentially, where the magnetic affinity complex and the signal affinity complex bind to the analyte to form a sandwich binding complex. The microcoil array is activated to move the sandwich binding complex to the detection zone of the fluidic network, where it is detected by the detection element, and where the detection of the sandwich binding complex indicates the presence of the analyte.”]; and
e. the analyte-linked particle complexes thus formed linking together at least one capture particle, at least one target biological analyte and at least one detection particle; the analyte-linked particle complexes thus formed permitting detection and quantification of the target biological analytes by discretely differentiating and enumerating the analyte-linked particle complexes that are present in a mixture that includes unbound capture and detection particles
[see para. 0023 disclosing “[a] detection system, of optical or electrical nature; for optical: an optical detection system consisting of a lens system and photo-diode, phototube or CCD sensing element, optionally, an optical illumination system consisting of a photo-diode, LED (light emitting diodes), laser or lamp, and a spectroscopy system which could contain diachronic mirror or lens…”]
[see para. 0048 disclosing: “Other applications for fluidic devices include cell and molecule detection and separation, capillary electrophoresis, isoelectric focusing, immunoassays, flow cytometry, sample injection of proteins for analysis via mass spectrometry, DNA analysis, cell manipulation, and cell separation. In one embodiment of the invention, magnetic materials and technologies and/or nanoparticles are incorporated into the fluidic devices for applications such as cell and biomolecule detection and/or separation. As used herein, the term “detecting the presence” refers to determining the existence, identity, and/or amount of an analyte in a particular sample.”]
As to claim 34, Su discloses that the target biological analyte may bind to a reagent that is conjugated to one type of particle chosen from a group consisting of
the capture particles; and
the detection particles; the reagent being bound to the type of particle chosen from the preceding group by a binding mechanism chosen from a group of binding mechanisms consisting of: a. covalent binding; and b. an affinity tag.
See paragraph 0058, disclosing the following.
“The catalytic element can be conjugated to the signal particle through a functionalized polymer. For example, a polymer with a functional group (i.e. aldehyde, amine, carboxylic acid, biotin) is used to conjugate the affinity agent and/or catalytic element to the particle. Conjugation can be through non-covalent interactions such as hydrophobic or electrostatic interactions, or through covalent interactions, such as amide bond formation.” [Examiner notes that biotin is an affinity tag, and Su also teaches alternatively conjugating via covalent interactions.]
As to claim 35, Su discloses at least one selected capture particle and one selected detection particle binds directly to their respective binding sites of the target biological analyte.
See paragraph 0034 disclosing:
“A “sandwich binding complex” comprises a magnetic affinity complex, a signal affinity complex, and analyte. For example, a sample suspected of comprising an analyte is introduced into the sample zone of the fluidic device. The analyte interacts sequentially or simultaneously with a magnetic affinity complex and a signal affinity complex to form a sandwich binding complex. Typically the affinity agent coupled to the magnetic particle is different than the affinity agent coupled to the signal particle, although both are complementary to the analyte. The microcoil array is activated to move the sandwich binding complex to the detection zone. Uncomplexed signal particles are left behind without being transported. The signal detected front the sandwich binding complex indicates the presence of the analyte. Typically this method is useful for determining the presence of proteins including peptides, antibodies and autoantibodies) or nucleic acids.” Para. 0034 (emphasis added). Examiner notes that it is understood that the magnetic particle and affinity agents are both coupled to the analyte at different binding sites.
As to claim 36, Su discloses that the detection particles includes molecular probes.
See paragraph 0034, discussed above, disclosing that typically the affinity agent coupled to the magnetic particle is different than the affinity agent coupled to the signal particle, although both are complementary to the analyte].
See also paragraph 0026 disclosing the following.
“As used herein, a “magnetic affinity complex” comprises a magnetic particle functionally coupled to an affinity agent. The term “affinity agent” generally refers to a molecule that binds to an analyte for the detection and/or analysis of the analyte and is described in more detail below. Non-limiting examples of affinity agents include example of affinity agents including antibodies, lectins, streptavidin, oligonucleotides, peptides, and oligosaccharides. It can be coupled to the magnetic particle using a functionalized polymer, for example”]. Para. 0026 (emphasis added).
As to claim 39, Su teaches that each subsystem included in a plurality of subsystems can be simultaneously differentiated and enumerated by a suitable method.
Regarding enumerating, see paragraph 0048 of Su disclosing the following.
“Other applications for fluidic devices include cell and molecule detection and separation, capillary electrophoresis, isoelectric focusing, immunoassays, flow cytometry, sample injection of proteins for analysis via mass spectrometry, DNA analysis, cell manipulation, and cell separation. In one embodiment of the invention, magnetic materials and technologies and/or nanoparticles are incorporated into the fluidic devices for applications such as cell and biomolecule detection and/or separation. As used herein, the term “detecting the presence” refers to determining the existence, identity, and/or amount of an analyte in a particular sample.” (Para. 0048, emphasis added).
Regarding “simultaneously differentiated and enumerated”, Su discloses the following.
“The arrays can be used to measure the expression levels of large numbers, e.g., tens, thousands or millions, of reactions or combinations simultaneously.” Para. 0077 (emphasis added).
“In another embodiment, one or more fluidic zones also comprise a signal affinity complex. The analyte is combined with the magnetic affinity complex and the signal affinity complex, either simultaneously or sequentially, where the magnetic affinity complex and the signal affinity complex bind to the analyte to form a sandwich binding complex.” Para. 0151 (emphasis added).
Claim 40 recites “a suitable technique for simultaneously and discretely differentiating and enumerating each subsystem included in a plurality of subsystems is chosen from a group consisting of: a. a technique for measuring optical properties; b. a technique for measuring electronic properties; c. a technique for measuring electromagnetic properties; d. a technique for measuring fluorescent properties; e. a technique for measuring radioisotopic properties; f. a technique for measuring chemical properties; g.. technique for measuring mass properties; h. technique for measuring size properties; i. a technique for measuring affinity properties; j. a technique for measuring material composition properties; and k. a technique for measuring density signature properties.” (Emphasis added).
Su teaches this in paragraph 0023 which discloses “[a] detection system, of optical or electrical nature; for optical: an optical detection system consisting of a lens system and photo-diode, phototube or CCD sensing element, optionally, an optical illumination system consisting of a photo-diode, LED (light emitting diodes), laser or lamp, and a spectroscopy system which could contain diachronic mirror or lens…” (para. 0023, emphasis added).
See also paragraph 0055 of Su, which discloses the following.
“The detection element can be an optical detection element or an electrical detection element. In certain embodiments, the optical detection element is selected from a Raman detector, a photon multiplier tube, a fluorescent reader, or an electrochemical sensor and the electrical detection element is selected from a FET element…” Para. 0055, emphasis added.
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.
Claim(s) 37, 38, 41 and 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20180372601 (hereinafter “Su”).
Su has been discussed above (see discussion of claim 33 above), but do not specifically disclose the limitations of claims 37, 38, 41, and 42. However, these limitations would have been obvious to one of ordinary skills in the art for the following reasons.
Claim 37 recites that an average 10 number of molecular probes [interpreted to mean about 10 molecular probes] on labeled capture particles that bind to the target biological analytes measures a concentration of the target biological analytes.
See paragraph 0048 of Su disclosing the following.
“Other applications for fluidic devices include cell and molecule detection and separation, capillary electrophoresis, isoelectric focusing, immunoassays, flow cytometry, sample injection of proteins for analysis via mass spectrometry, DNA analysis, cell manipulation, and cell separation. In one embodiment of the invention, magnetic materials and technologies and/or nanoparticles are incorporated into the fluidic devices for applications such as cell and biomolecule detection and/or separation. As used herein, the term “detecting the presence” refers to determining the existence, identity, and/or amount of an analyte in a particular sample.” (Para. 0048, emphasis added).
Examiner notes that determining an “amount” (para. 0048) encompasses concentration of the analyte, given that the analysis is performed in a fluid sample (see for example, paras. 0019, 0152 0155). Alternatively, determining a concentration of the analyte would have been obvious to one skilled in the art given that Su teaches determining an amount of the analyte in a fluid sample.
Regarding the limitation of 10 number of molecular probes, this limitation recites a workable or optimum range in which the general conditions of the claims are disclosed by Su. Discovery of a workable or optimum range requires ordinary skills in the art, as it merely requires modifying a known parameter, i.e., the number of subsystem, wherein the remaining conditions are substantially the same.
Claim 38 recites that at least one 15 binding affinity within the analyte-linked particle complexes having a coupling reagent included therein further comprises a modulating agent [interpreted to mean at least 15 analyte-linked particle complexes further comprise a modulating agent].
Regarding the modulating agent limitation, see paragraphs 0056 and 0057 of Su which discloses the following.
“In further embodiments, the detection zone comprises a reaction substrate. A “reaction substrate” is a material or substance upon which an enzyme (such as the catalytic element) acts. The product of the reaction can be fluorogenic, chemiluminescent, or detectable by UV-visible light (such as by a color change). Non-limiting examples of reaction substrates include Lumigen APS-5, Lumigen TMA-6, Lumigen PS-alto, Lumigen PS-3, H.sub.2O.sub.2 with an oxidizable compound, Amplex Red, 3, 5, 3′, 5′-tetramethylbenzidine (TMB), glucose, O.sub.2, ATP, M.sup.2+, luciferin, inoluciferin, quinolinyl, coelentrazine, aldehyde, FMNH.sub.2, and analogs and combinations thereof.” Para. 0056 (emphasis added).
“Typically, if the detection zone comprises a reaction substrate, the magnetic affinity complex and/or the signal affinity complex comprises a catalytic element. The “catalytic element” is an external compound that serves as an agent to cause a chemical reaction to occur in the reaction substrate, which reaction product is detectable by the detection element. In certain embodiments, the catalytic element is selected from the group consisting of alkaline phosphatase, horseradish peroxidase, glucose oxidase, luciferase (from firefly, Renilla, bacteria, or other sources) or analogs or combinations thereof.” Para. 0057 (emphasis added).
[The catalytic element is equivalent to Applicant’s modulating agent.]
Regarding the limitation of at least 15 complexes in claim 38, this limitation recites a workable or optimum range in which the general conditions of the claims are disclosed by Su. Discovery of a workable or optimum range requires ordinary skills in the art, as it merely requires modifying a known parameter, i.e., the number of subsystem, wherein the remaining conditions are substantially the same.
Claim 41 recites that simultaneously and discretely differentiating and enumerating various analyte linked particle complexes and unbound particles within each 15 subsystem included in a plurality of subsystems is effected by a multi-parameter particle counter included in the system that is selected from a group consisting of:
a. a flow cytometer; b. an imaging microscope; and c. a laser-scanning microscope.
See paragraph 0048 of Su disclosing the following.
“Other applications for fluidic devices include cell and molecule detection and separation, capillary electrophoresis, isoelectric focusing, immunoassays, flow cytometry, sample injection of proteins for analysis via mass spectrometry, DNA analysis, cell manipulation, and cell separation. In one embodiment of the invention, magnetic materials and technologies and/or nanoparticles are incorporated into the fluidic devices for applications such as cell and biomolecule detection and/or separation. As used herein, the term “detecting the presence” refers to determining the existence, identity, and/or amount of an analyte in a particular sample.” (Para. 0048, emphasis added).
Regarding the limitation of 15 subsystem in claim 41, this limitation recites a workable or optimum range in which the general conditions of the claims are disclosed by Su. Discovery of a workable or optimum range requires ordinary skills in the art, as it merely requires modifying a known parameter, i.e., the number of subsystem, wherein the remaining conditions are substantially the same.
As to claim 42, Su teaches that a concentration of the target biological analyte is derived from discretely differentiating and enumerating at least one group of analyte linked particle complexes, wherein each group of analyte-linked 5 particle complexes consists of a unique number of capture particles and a unique number of detection particles.
See paragraph 0048 of Su disclosing the following.
“Other applications for fluidic devices include cell and molecule detection and separation, capillary electrophoresis, isoelectric focusing, immunoassays, flow cytometry, sample injection of proteins for analysis via mass spectrometry, DNA analysis, cell manipulation, and cell separation. In one embodiment of the invention, magnetic materials and technologies and/or nanoparticles are incorporated into the fluidic devices for applications such as cell and biomolecule detection and/or separation. As used herein, the term “detecting the presence” refers to determining the existence, identity, and/or amount of an analyte in a particular sample.” (Para. 0048, emphasis added).
Regarding the limitation of 5 particle complexes of a unique number of capture particles or a unique number of detection particles, recited in claim 42, this limitation recites a workable or optimum range in which the general conditions of the claims are disclosed by Su. Discovery of a workable or optimum range requires ordinary skills in the art, as it merely requires modifying a known parameter, i.e., the number of subsystem, wherein the remaining conditions are substantially the same.
Conclusion
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/Ann Montgomery/Primary Examiner, Art Unit 1678