DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Amendments
2. The claims filed Nov. 17, 2025 have been entered. Claims 21, 23-24 have been amended. It is noted that claim 24 was not properly identified as “Currently Amended”. Claims 7, 11, 20, 22 and 32-33 are cancelled.
Election/Restrictions
3. Applicant’s election of Group H in the reply filed on Nov. 17, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 2-4, 8-10, 12, 14-19, 21, and 23-25 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on Nov. 17, 2025.
4. Claims 1, 5-6, 13 and 26-31 are under consideration in this Office Action.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on Oct. 13, 2023 and June 25, 2024 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
6. Claim 28 is objected to because of the following informalities: Claim 28 is not further limiting. Claim 28 does not add any additional components to the kit of claim 26. 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.
7. Claims 1, 5-6, 13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps and elements. See MPEP § 2172.01. The omitted elements and steps are:
Claims 1 and 3 do not require the inclusion of any antibody.
Claims 1 and 13 do not require any of the samples to be contacted with any antibody by which an antigen-antibody reaction is produced.
Claims 1, 5-6 and 13 do not recite the inclusion of a detectable label or signal, which is required to determine the presence and/or amount of bacteria.
Therefore the rejected claims are incomplete and further clarification is required to overcome the instant rejection.
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.
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.
8. Claims 1, 5-6, 13 and 26-31 are rejected under 35 U.S.C. 102(a)(1) and/or 192(a)(2) as being anticipated by Etoh et al., (US 20040014943 published 2004-01-22; priority to 2001-01-31)
The claims are drawn to a method for detecting the presence and/or amount of bacteria in a sample selected from food or beverage samples, environmental samples, and biological samples, the method comprising the step of simultaneously detecting the presence and/or amount of at least bacteria of two or more different genera in the sample based on antigen-antibody reactions.
Etoh et al., disclose an anti-L7/L12 antibody for detecting bacteria. Etoh et al., describe an antibody for detection of microorganisms, a method of detection of microorganisms, and a reagent kit for detection of microorganisms, which is species specific for every species of microorganisms and with which all serototypes within the same species can be detected, are provided. Antibody to intracellular molecules with the same function in each type of microorganism, particular antibody to ribosomal protein, that is, ribosomal protein L7/Ll2, is made and antibody that reacts specifically with the microorganism in question is selected [abstract]. The L7/L12 antibody recognizes Hemophilus influenzae, Helicobacter pylori; S. pneumoniae; N. gonorrhoeae [para 38-45 and 52]. See Table 6 for simultaneous detection of Hemophilus influenzae, S. pneumoniae; and N. gonorrhoeae using the detection of microorganisms in the so-called sandwich assay by optical immunoassay and ELISA method, in combination with an anti-ribosomal protein L7/L12 antibody which is specific to each microorganism [para 222]. Thus teaching the at least genera of claims 1, 3-4 and 13. Etoh et al., disclose the invention can be useful for detecting the species Chlamydia pneumoniae in test samples, such as from throat swabs, tissue samples, body fluids, experimental solutions and cultures [para 6]. Thus describing the claimed sample types.
Antibody can be used in all known types of immunoassay, such as aggregation whereby said antibody is adsorbed on polystyrene latex, ELISA, which is a conventional technology performed in a microtiter plate, conventional immunochromatography, sandwich assay, whereby said antibody labeled with colored particles or particles that have coloring capability, or enzymes or phosphor, and magnetic particles coated with capture antibody are used [para 86]. Thus describing the chromatography of claim 30. Moreover, antibody that is made based on the present invention can simultaneously function in any of these immunoassay methods as a so-called-capture antibody that captures said antigen protein in solid or liquid phase and a so-called enzyme-labeled antibody by modification using an enzyme, such as peroxidase and alkali phosphatase, etc., by conventional methods [para 87]. Thus describing claim 31. The optical immunoassay (OIA) technology has been previously described where microorganisms are detected by an optical interference induced by an antibody reaction on the optical thin film which is formed by silicone or silicon nitride, is a useful detection method using an antibody [para 70]. Thus describing claim 27. The monoclonal antibody was used and evaluated as a capture antibody to be immobilized on a silicon wafer having a silicon nitride thin film layer (an insoluble membrane carrier) in the OIA method. Moreover, peroxidase-labeled AMGC-1 monoclonal antibody which can non-specifically react with ribosomal proteins L7/L12 protein of a variety of microorganisms described in Reference Example was used as the detect antibody [para 151]. Thus describing the detection steps of claim 13.
The antibody of the present invention specific to a variety of microorganisms that has been obtained by the methods can be used in a variety of immunoassay methods to obtain diagnostic reagent kits specific to a variety of microorganisms. For example, this antibody can be used in aggregation reactions where antibody is adsorbed on polystyrene latex particles, ELISA, which is a conventional technology performed in a microtiter plate, conventional immunochromatography methods, sandwich assay, whereby said antibody labeled with colored particles or particles that have coloring capability, or with enzyme or phosphor, and magnetic microparticles coated with capture antibody, etc., are used [para 68]. Thus teaching claim 28. An object of the present invention is also to provide a method for specifically and rapidly detecting a microorganism, a detection antibody used for the detection and a reagent kit for the detection. Furthermore, another object of the present invention is to provide a method for manufacturing the detection antibody used for the detection [para 224]. Thus describing a capture and detection antibody just as instantly claimed. Finally, Etoh et al. disclose a method of detecting the microorganism comprising: a) contacting a test sample with a lysing solution, and extracting ribosomal protein from the microorganism; b) contacting the extracted test sample with a captured antibody, wherein said antibody is fixed on a solid surface, and forms an antigen-antibody complex from the ribosomal protein and the capture antibody, and c) detecting the antigen-antibody complex using a detection antibody [claim 21].
With regard the claim 27, the kit will not have a detection line until a detectably labeled antibody-antigen complex is captured/immobilized on the detection line. At best, the kit will only includes the insoluble membrane carrier.
Therefore Etoh et al., anticipate the instantly rejected claims.
Claim Rejections - 35 USC § 102
9. Claims 1, 5-6, 13 and 26-31 are rejected under 35 U.S.C. 102(a)(1) and/or 192(a)(2) as being anticipated by Shirai et al., (WO 2000006603 published 2000-02-10; priority to 1999-07-30).
The claims are drawn to a method for detecting the presence and/or amount of bacteria in a sample selected from food or beverage samples, environmental samples, and biological samples, the method comprising the step of simultaneously detecting the presence and/or amount of at least bacteria of two or more different genera in the sample based on antigen-antibody reactions.
Shirari et al., disclose an antibody for detecting a microorganism whereby all serotypes of a single species can be detected; a method for constructing this antibody; a method for detecting a microorganism; and reagent kits for detecting a microorganism. Antibodies against the same functional molecules in cells of various microorganisms, particularly ribosomal proteins and still particularly a ribosomal protein L7/L12, are constructed and an antibody reacting specifically with the target microorganism is selected [abstract]. Shirari et al., found that intracellular molecules which are present in all microbial cells and whose amino acid structure has some differences between microorganisms, in particular, ribosomal protein L7 / L12 (Ribosomal Protein L7 / L12). Ribosomal Protein L7 / L12 is a protein with a molecular weight of about 13 kilodaltons, which is known to be a ribosomal protein essential for protein synthesis, and its amino acid sequence in several microorganisms. Analysis is progressing, and homology of about 50% to 65% amino acid sequence among microorganisms has been confirmed [Disclosure of the Invention]. It was found that detection was possible for all serotypes that were specific to various microorganisms and within the same strain. For example, Haemophilus influenzae, Streptococcus pneumoniae and N. gonorrhoeae were used to develop immunological diagnostic techniques for microbial species using their specific antibodies. The present invention has been completed by finding that an antibody specific to the protein can be obtained in each of the microorganisms, and that the use of the antibody enables specific detection of each bacterium [Disclosure of the Invention]. Example 4 teach monoclonal antibodies that react with L7/L12 proteins of H. influenzae, N. gonorrhoeae, N. lactamica, E coli, E. faecalis, K. pneumonaie, N. meningitidis, P aeruginosa, Group B Streptococcus, S. aureus, S. pneumoniae, S. pyrogenes evaluated by ELISA See Table 1 and Table 2. Shirari et al., clearly describe simultaneously detecting the presence and/or amount of at least bacteria of two or more different genera in the sample based on antigen-antibody reactions. Example 10 uses a blood sample to perform detection using an immobilized polyclonal antibody. Thereby describing claims 1, and 5-6.
Antibodies specific to various microorganisms have been obtained in which the antibodies are adsorbed on polystyrene latex particles, and an ELISA method which is a known technique performed in a microtiter plate. All known methods, such as the existing immunochromatography method, colored particles or particles having a color-forming ability, or sandwiches using magnetic particles (a solid phase carrier) coated with a capture antibody together with the antibody labeled with an enzyme or a fluorescent substance. Reagents for detection of microorganisms of various purposes by utilizing the immunoassay technique A kit can be provided [Detailed Description]. Shirari et al., disclosing a capture and labeled detection antibodies and solid phase carriers just as instantly recited. In the Optical immunoassay method, a reaction substrate was prepared by reacting an antibody for capture on a silicon wafer (solid phase carrier) having a thin layer of silicon nitride (an insoluble membrane carrier), and an antigenic substance, was reacted for a certain period of time. After that, the captured antigen is further reacted with the enzyme-labeled antibody (amplification reagent), and finally the antigen-antibody reaction can be visually determined by the light interference color due to the thin film precipitation generated by adding the substrate solution. Shirari et al., disclose claim 13.
The microorganism detection method using an antibody includes, for example, an agglutination reaction in which the antibody is adsorbed on polystyrene latex particles, an ELISA method, which is a known technique performed in a microtiter plate, an existing immunochromatography method, a colored particle or a colorant. This corresponds to a detection method using a known immunoassay technique such as sandwich or the like using magnetic particles or the like coated with a capture antibody together with particles or the antibody labeled with an enzyme or a fluorescent substance [Detailed Description]. In addition, the antibody prepared according to the present invention can function as a capture antibody that captures the antigen protein in a solid phase or a liquid phase in all immunoassay techniques, and at the same time, uses an enzyme. Modification by a known method can function as a so-called enzyme-labeled antibody. The sandwich assay is used for antibody evaluation, and the prepared monoclonal antibody is chemically bound to peroxidase to form an enzyme-labeled antibody [See Example 4].
Reagent kits for detecting microorganisms using antibodies against intracellular molecules of the same function for various microorganisms. Shirari et al., describe monoclonal and polyclonal antibodies. In addition, the antibodies can function as a capture antibody that captures the antigen protein in a solid phase or a liquid phase in all immunoassay techniques, and at the same time, uses an enzyme. Modification by a known method can function as a so-called enzyme-labeled antibody. The prepared monoclonal antibody was used as a capture antibody to be immobilized. As the detect antibody, an AMGC-1 monoclonal antibody capable of non-specifically reacting with Ribosomal Protein L7 / L12 proteins of various microorganisms which was enzymatically labeled with peroxidase. In addition, by using a reagent kit for detecting microorganisms comprising such an antibody as a component, the detection of microorganisms can be performed more generally and accurately [Industrial Applicability].
With regard the claim 27, the kit will not have a detection line until a detectably labeled antibody-antigen complex is captured/immobilized on the detection line. At best, the kit will only includes the insoluble membrane carrier. Therefore Shirari et al., anticipate each and every limitation of the instantly rejected claims.
Claim Rejections - 35 USC § 102
9. Claims 1, 5-6, 13 and 26-31 are rejected under 35 U.S.C. 102(a)(1) and/or 192(a)(2) as being anticipated by Maehana et al., (WO2015093545 published 2016-11-03; priority to 2014-12-17).
The claims are drawn to a method for detecting the presence and/or amount of bacteria in a sample selected from food or beverage samples, environmental samples, and biological samples, the method comprising the step of simultaneously detecting the presence and/or amount of at least bacteria of two or more different genera in the sample based on antigen-antibody reactions.
Maehana et al., disclose detection method using an immunochromatographic device, and detection kit comprising an immunochromatographic device for detecting whether causative bacteria of mastitis are coliform bacteria or not by using milk of a livestock animal [abstract]. Thus disclosing a beverage sample. The specific substance is more preferably the L7/L12 ribosomal protein of a bacterium. High detection sensitivity can be obtained for the L7/L12 ribosomal protein, since it exists in cells in a large copy number. The antibody can recognize a particular bacterium that causes mastitis with distinguishing it from other bacteria at species or genus level can actually be obtained by the known method described below. Types of the bacteria are not particularly limited, and they may be gram-positive bacteria, or gram-negative bacteria. Examples include, for example, gram-positive bacteria such as staphylococci (bacteria belonging to the genus Staphylococcus), preferably Staphylococcus aureus, Escherichia coli, bacteria belonging to the genus Klebsiella, and so forth, but the bacteria are not limited to these [para 92]. A monoclonal antibody that recognizes a substance other than the ribosomal protein L7/L12 as an antigen may also be used, so long as the antibody is a monoclonal antibody that reacts with a component of a specific bacterium that causes mastitis or a substance secreted by such a bacterium, but does not react with a component of a bacterium that causes mastitis other than the foregoing specific bacterium or a substance secreted by such a bacterium [para 94]. Thus describing claim 6. This method for detecting, detects multiple kinds of microorganisms [para 6]. Thus disclosing claim 5.
The test strip may be used as it is as an immunochromatographic device, or the test strip may be stored in a case to constitute an immunochromatographic device. The immunochromatographic device is preferably used by directly immersing one end of the test strip into the sample contained in a container. In the latter case, if the volume of milk as a sample is small, the immunochromatographic device is preferably used by measuring a predetermined volume of the sample with a pipette or the like, and dropping the sample to the test strip. In the latter case, the case may have any shape so long as the test strip can be stored. The case may be formed with any material, and preferred examples include polypropylene, polycarbonate, and so forth [para 96]. Thus describing a milk sample as recited by claim 1.
The immunochromatographic device of the present invention can also be provided as a kit comprising a container such as microtube, and an additive solution [para 97]. Therefore describing claim 28. Maehana et al., disclose the preparation of immunochromatographic device and a gold colloid labeled antibody impregnated member [para 98]. A glass fiber pad of a strip-like shape was impregnated with the gold colloid-labeled antibody solution and dried at room temperature under reduced pressure to obtain a gold colloid-labeled antibody-impregnated member (first part) [para 100]. A nitrocellulose membrane was prepared as a membrane carrier 2 for chromatographic development with chromatography medium (second part) [para 101]. Thus teaching claims 26-29.
Maehana et al., disclose the preparation of an immunochromatographic Device. A sectional view of immunochromatographic device is shown in FIG. 1. In addition to the aforementioned labeled antibody-impregnated member 1 and membrane carrier 2 for chromatographic development, (filter member 4 consisting of glass fibers, and retention particles were adhered to each other as a member serving as both the member for sample addition and the member for removal of fat globules (third part), and filter paper as the member 5 for absorption was further prepared. After these members were adhered on a substrate 6 (polystyrene, having adhesive for adhering the members), to prepare the immunochromatographic device [para 103]. Thus describing claims 30-31.
With regard the claim 27, the kit will not have a detection line until a detectably labeled antibody-antigen complex is captured/immobilized on the detection line. At best, the kit will only includes the insoluble membrane carrier. Therefore Maehana et al., anticipate each and every limitation of the instantly rejected claims.
Pertinent Art
10. The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure.
Sawa et al., (J Clin Microbiol. 2013 Jan;51(1):70–76) . Sawa et al., describe the capsular antigen detection (CAD) kit is widely used in clinics to detect Streptococcus pneumoniae infection from urine, because it is rapid, convenient, and effective. However, there are several disadvantages, including false-positive results in children colonized with S. pneumoniae and prolonged positive readings even after the bacteria have been cleared.
Nag et al., (Biochemistry. January 1, 1987) describe Monoclonal antibodies to epitopes in both C-terminal and N-terminal domains of Escherichia coli ribosomal protein L7/L12 inhibit elongation factor binding.
PNG
media_image1.png
200
240
media_image1.png
Greyscale
Particle Immunoassays use antibody-coated latex beads that clump (agglutinate) or form colored lines on a strip when they bind to a target substance (antigen/antibody).
Immunoassay detection uses colored particles or enzyme-triggered color changes to create visible lines on test strips, indicating the presence of an analyte. These lines, a test line and a control line, form as labeled antibodies bind to target molecules (antigens/antibodies) in the sample, allowing for rapid visual interpretation (positive/negative) or quantitative analysis (line intensity/optical density) with instruments.
Immunoassay detection using magnetic particles combined with line detection, involves using antibody-coated superparamagnetic nanoparticles as labels that bind to targets (analytes) in a sample, creating visible lines on a membrane for rapid diagnostics, offering high sensitivity by enhancing signals through particle aggregation or using magnetic readers for quantification
Conclusion
11. No claims allowed.
12. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JA-NA A HINES whose telephone number is (571)272-0859. The examiner can normally be reached Monday thru Thursday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor Vanessa Ford, can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/JANA A HINES/Primary Examiner, Art Unit 1645