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
Applicant's election with traverse of Group I, claims 1-34, 43, 48-59 in the reply filed on 10/26/2025 is acknowledged. The traversal is on the ground(s) that the different inventions are not mutually independent because the system is specifically designed to carry out the method. Likewise, the different inventions share a single general inventive concept because the method and the system aim to achieve the same core objective-detecting, quantitating or monitoring pathogens and are directed to the same technical solution. Applicant states that the restriction should be withdrawn and the method examined with the system.
All of the arguments have been thoroughly reviewed and considered but are not found persuasive because even though the different inventions may share the same technical feature, this feature upon which Applicant relies is not special and does not provide a contribution over the prior art as evidence by the international search report made of record 3/8/2023. Additionally, the method is recited at a high level of generality such that there is no evidence provided that the method is mutually exclusive to the system recited herein and vice versa. The requirement is still deemed proper and is therefore made FINAL. Accordingly, the claims 35-42, 44-47, and 60-73 are withdrawn from consideration as being drawn to a non-elected invention.
Priority
This application is a 371 of PCT/US2020/043112 filed 07/22/2020 which claims benefit of 62/877,783 filed 07/23/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/8/2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 3/8/2023 is acknowledged. These drawings are found acceptable by the examiner.
Claim Objections
Claims 9-34 and 52- 59 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim(s) cannot depend from another multiple dependent claim(s). See MPEP § 608.01(n). Accordingly, the claims 9-34 and 52- 59 not been further treated on the merits.
Appropriate correction is required.
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 2 and 5-7 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.
(a) Claims 2 and 7 are indefinite at the recitation of the phrase "such as" because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Thus, the metes and bounds of the claimed limitations are unclear.
(b) Claims 5 and 6 are indefinite and confusing at wherein said “cross-sectional area of the ….column is constant or varies” is confusing because it is unclear what is meant by constant or varies. The limitations “constant” and “varies” are not a common term of art in reference cross-sectional structure features, the specification does not provide a limiting definition of the terms as it relates to the cross-sectional features of the column, and thus the metes and bounds of the limitation cannot be ascertained. Clarification is required.
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 (i.e., changing from AIA to pre-AIA ) 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.
Note: given the ambiguity and broad language recited in the pending claims, the claims under examination, claims 1-8, 43 and 48-51, are being given the broadest reasonable interpretation by the examiner for the purpose of application of prior art.
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.
Claim(s) 1-8, 43 and 48-51 is/are rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by Clarizia et al {Clarizia, used interchangeably herein} (CA 2895945 {WO 2014100456}, pub date June 2014, filing date December 2012).
Regarding claims 1, 43 and 48, Clarizia teaches a method of detecting pathogens, comprising detecting pathogens, comprising: capturing one or more live pathogen from a contaminating matrix within a sample by aptamer-based capture or antibody-based capture (abstract, page 6, lines 8-20; page 8, line 30- page 9, line 9; col. 13, line 10 to page 14; see also 30-31; page 132, line 25-28 and page 131, lines 16-19); and releasing the one or more captured lived pathogens from aptamers or antibodies, thereby allowing the one or more live pathogens to be detected without regarding cell culture (pages 23, line 30 to page 24, line 10; see also pages 40-46). Clarizia teaches wherein the pathogen may encompass foodborne pathogens or infectious particles (page 8, lines 30-31; and pages 9-10, section entitled “Samples” and “Targets”). See also bottom of page 7 bridging top of page 8 which teaches that the method is fully integrated into a system to perform several processes on a sample inputted into a cartridge to achieve a final result, such as live cell capture or isolated nucleic acid from a target cell without user manipulation and page 143, line 3 which teaches wherein no culturing of pathogen is required for isolating a target analyte.
Regarding claim 2, Clarizia teaches the method of claim 1, wherein the one or more live pathogens is one or more disease producing organism, wherein said organism is a bacterium (see page 8, lines 30-31; and pages 9-10, section entitled “Samples” and “Targets”).
Regarding claim 3, Clarizia teaches the method of claim 1, wherein the one or more live pathogens is one or more pathogens in a sample from food, water, environment, soil, plant, animal, insect, or human (see page 8, lines 30-31; and pages 9-10, section entitled “Samples” and “Targets”).
Regarding claim 4, Clarizia teaches the method of any one of claims 1-3, wherein capturing one or more live pathogens comprises applying the sample to a pathogen-isolation column containing multiple beads of one or more sizes (page 3, line 16 to page 4, line 7; page 6, lines 8-21; see also pages 11-12, 31 which teaches pre-column and column/filter structures for affinity capture and page 126 which teaches beads packed into column).
Regarding claims 5-8 Clarizia teaches the method of claim 4, wherein the magnetic assembly can be the same or different in the column structure (page 14, lines 5-6; page 42, lines 10-11). Clarizia teaches wherein the column may have varied shape that such orthogonal which allows for uniform flow and planar which may allow for non-uniformity (page 30). Clarizia teaches cross-sectional area of the pathogen capture column wherein the flow rate can be varied or constant (pages 56, lines 21-23, page 147, lines 20-22).
Regarding caim 49, Clarizia teaches the method of claim 48, wherein the one or more infectious particles is one of bacteria or virus (e.g., page 73, line 2-5).
Regarding claim 50, Clarizia teaches the method of claim 48 or claim 49, wherein capturing one or more infectious particles comprises applying the sample to an isolation column containing multiple beads of one or more sizes (page 59, lines 1-3, page 94, line 7-8, page 125, lines 8-11, page 131, line 3; page 142, line 1-2 which discuss a size of the beads).
Regarding claim 51, Clarizia teaches, the method of claim 50, wherein bead surface of each of the multiple beads comprises a material that has been modified for aptamer or antibody attachment (see e.g., page 131, lines 16-19). Thus, Clarizia meets the limitations of the claims recited above.
Claim(s) 1-4, 43 and 48-51 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ingber et al (US 20140227723, August 2014).
Regarding claim 1, Ingber teaches a method for detecting, quantitating and/or monitoring pathogens (para [0003] - "Described herein relates generally to molecules, products, kits and methods for detecting and/or removing microbes in a sample"; para [0011] - "diagnosis and/or treatment of diseases caused by microbes or pathogens"; para (0018] “detecting the presence or absence of, and/or differentiating between, different microbes or pathogens"), comprising: capturing one or more live pathogens from a contaminating matrix within a sample by aptamer-based capture or antibody-based capture (para (0011) - “engineered microbe-targeting molecules described herein provide a...diagnosis and/or treatment of diseases caused by microbes or pathogens, removal of microbes or pathogens from a sample, including bodily fluids and tissues of a subject, foods, water, or an environmental surface"; para [0032] - "The membrane can be mixed with a test sample (e.g., blood sample), washed, incubated with a desired detecting protein (e.g., AP-labeled FcMBL or specific antibody for certain microbes, e.g., bacteria or fungus)"); and releasing the one or more captured live pathogens from aptamers or antibodies (para [0188] - "Exemplary methods to recover or isolate bound microbes and/or microbial compounds/fragments from the engineered microbe-binding molecules and/or substrates, prior to any characterization analysis, include, but are not limited to, Ca2+ chelation to release captured materials from the engineered microbe-binding molecules and/or substrates"), thereby allowing the one or more live pathogens to be detected, quantitated and/or monitored without requiring cell culture (para {0030} - "FIG. 11 is a graph showing results of detecting C. albicans in blood. Serial dilutions of C. albicans were spiked into blood, captured by AKT-FcMBL magnetic microbeads (1 um) and detected by an ELISA method using HRP-labeled FcMBL."; para [0049] - "FIGS. 30A-30B are images showing binding of one or more embodiments of microbe-targeting substrates to microbial matter, including live microbes"; para [0302] - "In some embodiments, microscopic imaging can be used to detect signals from label on the labeling agent."):
Regarding claim 2, ingber teaches the method of claim 1, wherein the one or more live pathogens is one or more disease producing organism, such as bacteria, fungi, protozoa and/or worms (para [0049] - "FIG. 30A shows that microbial outgrowth is observed when one or more microbe-targeting substrates (e.g., FcMBL-coated fluorescent microbeads) bind(s) to at least one live microbe, e.g., E. coli."; para [0034] - "FIG, 15 is an image showing direct detection of bacteria on a membrane by AP-labeled FcMBL. Serial dilutions of E. coli and S. aureus").
Regarding claim 3, Ingber teaches the method of claim 1, wherein the one or more live pathogens is one or more pathogens in a sample from food, water, environment, soil, plant, animal, insect, or human (para [0011] - “engineered microbe-targeting molecules described herein provide a...diagnosis and/or treatment of diseases caused by microbes or pathogens, removal of microbes or pathogens from a sample, including bodily fluids and tissues of a subject, foods, water, or an environmental surface").
Regarding claim 4, Ingber teaches the method of any one of claims 1-3, wherein capturing one or more live pathogens comprises applying the sample to a pathogen-isolation column containing multiple beads of one or more sizes (Abstract - "In some embodiments, the microbe- targeting molecules or microbe-binding molecules can be conjugated to a substrate, e.g., a magnetic microbead, forming a microbe- targeting substrate (e.g., a microbe-targeting magnetic microbead). Such microbe-targeting molecules and/or substrates and the kits comprising the same can bind and/or capture of a microbe and/or microbial matter thereof"; para [0139] - "The solid substrate can be made from...magnetic microbeads, and the like)... tubes, hollow fibers...channels, other substrates commonly utilized in assay formats, and any combinations thereof."; para [0763] - "To determine the optimal microbead size for capturing both fungi and bacteria, the binding of Candida to microbeads (with a size ranging between ~1 um and ~128 nm) coated with AKT Fc MBL was evaluated”; para [0115] - "the engineered microbe-targeting molecules can be immobilized on a solid substrate for easy handling during usage, e.g., for isolation”).
Regarding claim 43, Ingber teaches a method for detecting, quantitating and/or monitoring pathogens (para [0003] - "Described herein relates generally to molecules, products, kits and methods for detecting and/or removing microbes in a sample"; para [0011] - "diagnosis and/or treatment of diseases caused by microbes or pathogens"), comprising: capturing one or more foodborne pathogens from a contaminating matrix within a sample by aptamer-based pathogen capture or antibody/antigen pathogen capture (para [0011] - “engineered microbe-targeting molecules described herein provide a...diagnosis and/or treatment of diseases caused by microbes or pathogens, removal of microbes or pathogens from a sample, including bodily fluids and tissues of a subject, foods, water, or an environmental surface”; para [0032] - "The membrane can be mixed with a test sample (e.g., blood sample), washed, incubated with a desired detecting protein (e.g., AP-labeled FcMBL or specific antibody for certain microbes, e.g., bacteria or fungus)"); and releasing the one or more captured foodborne pathogens from aptamers or antibodies (para [0188] - "Exemplary methods to recover or isolate bound microbes and/or microbial compounds/fragments from the engineered microbe-binding molecules and/or substrates, prior to any characterization analysis, include, but are not limited to, Ca2+ chelation to release captured materials from the engineered microbe-binding molecules and/or substrates"), thereby allowing the one or more foodborne pathogens to be detected, quantitated and/or monitored without requiring cell culture (para [0030] - “FIG. 11 is a graph showing results of detecting C. albicans in blood. Serial dilutions of C. albicans were spiked into blood, captured by AKT-FcMBL magnetic microbeads (1 um) and detected by an ELISA method using HRP-labeled FcMBL."; para [0049] - "FIGS. 30A-30B are images showing binding of one or more embodiments of microbe-targeting substrates to microbial matter, including live microbes"; para (0302) - “In some embodiments, microscopic imaging can be used to detect signals from label on the labeling agent.”).
Regarding claim 48, Ingber teaches a method for detecting, quantitating and/or monitoring infectious particles (para [0003] - "Described herein relates generally to molecules, products, kits and methods for detecting and/or removing microbes in a sample"; para [0011] - “diagnosis and/or treatment of diseases caused by microbes or pathogens"), comprising: capturing one or more infectious particles from a contaminating matrix within a sample by aptamer-based capture or antibody/antigen capture (para (0011) - “engineered microbe-targeting molecules described herein provide a...diagnosis and/or treatment of diseases caused by microbes or pathogens, removal of microbes or pathogens from a sample, including bodily fluids and tissues of a subject, foods, water, or an environmental surface”; para [0032] - "The membrane can be mixed with a test sample (e.g., blood sample), washed, incubated with a desired detecting protein (e.g., AP-labeled FcMBL or specific antibody for certain microbes, e.g., bacteria or fungus)"; para [0177] "the presence of pathogen-originating cell fragments or matter derived from pathogens can be diagnostic of an infectious disease in a subject"); and releasing the one or more captured infectious particles from aptamers or antibodies (para [0188] - “Exemplary methods to recover or isolate bound microbes and/or microbial compounds/fragments from the engineered microbe-binding molecules and/or substrates, prior to any characterization analysis, include, but are not limited to, Ca2+ chelation to release captured materials from the engineered microbe- binding molecules and/or substrates"), thereby allowing the one or more infectious particles to be detected, quantitated and/or monitored without requiring cell culture (para (0030) - "FIG. 11 is a graph showing results of detecting C. albicans in blood. Serial dilutions of C. albicans were spiked into blood, captured by AKT-FcMBL magnetic microbeads (1 um) and detected by an ELISA method using HRP- labeled FcMBL."; para [0049] - "FIGS. 30A-30B are images showing binding of one or more embodiments of microbe-targeting substrates to microbial matter, including live microbes"; para [0302] - "In some embodiments, microscopic imaging can be used to detect signals from label on the labeling agent.”).
Regarding claim 49, Ingber teaches the method of claim 48, wherein the one or more infectious particles is one of bacteria, viruses, fungi, protozoa, worms, proteins and peptides (para [0049] - "FIG. 30A shows that microbial outgrowth is observed when one or more microbe- targeting substrates (e.g., FCMBL-coated fluorescent microbeads) bind(s) to at least one live microbe, e.g., E. coli."; para (0034] - "FIG. 15 is an image showing direct detection of bacteria on a membrane by AP-labeled FcMBL. Serial dilutions of E. coli and S. aureus").
Regarding claim 50, Ingber teaches the method of claim 48 or claim 49, wherein capturing one or more infectious particles comprises applying the sample to an isolation column containing multiple beads of one or more sizes (Abstract - "In some embodiments, the microbe- targeting molecules or microbe-binding molecules can be conjugated to a substrate, e.g., a magnetic microbead, forming a microbe- targeting substrate (e.g., a microbe-targeting magnetic microbead). Such microbe-targeting molecules and/or substrates and the kits comprising the same can bind and/or capture of a microbe and/or microbial matter thereof"; para [0139] - "The solid substrate can be made from...magnetic microbeads, and the tike)... tubes, hollow fibers...channels, other substrates commonly utilized in assay formats, and any combinations thereof.", para [0763] - "To determine the optimal microbead size for capturing both fungi and bacteria, the binding of Candida to microbeads (with a size ranging between 1 um and 128 nm) coated with AKT Fe MBL was evaluated", para [0115] - "the engineered microbe-targeting molecules can be immobilized on a solid substrate for easy handling during usage, e.g., for isolation").
Regarding claim 51, Ingber teaches the method of claim 50, wherein bead surface of each of the multiple beads comprises a material that has been modified for aptamer or antibody attachment (Abstract - "Some particular embodiments of the microbe-targeting or microbe- binding molecules comprise a carbohydrate recognition domain of mannose-binding lectin, or a fragment thereof, linked to a portion of a Fe region. In some embodiments, the microbe-targeting molecules or microbe-binding molecules can be conjugated to a substrate, e.g., a magnetic microbead, forming a microbe-targeting substrate (e.g., a microbe-targeting magnetic microbead).").
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/ Primary Examiner, Art Unit 1681