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 .
DETAILED ACTION
Status of Claims
1. Applicant's preliminary amendment filed January 18, 2024 is acknowledged and has been entered. The amended abstract of the specification is also accepted and has been entered. Claims 1, 4, and 7-14 have been amended. Claims 2, 3, 5, and 6 have been cancelled. Claim 17 has been added. Accordingly, claims 1, 4, and 7-17 are pending and are under examination.
Priority
2. Receipt is acknowledged of certified copies of foreign priority papers required by 37 CFR 1.55, which papers have been placed of record in the file.
3. Acknowledgment is made of Applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon an application filed in JAPAN on 10/07/2019. The claim for priority cannot be based on said application because the subsequent nonprovisional or international application designating the United States was filed more than twelve months thereafter and no petition under 37 CFR 1.55 or request under PCT Rule 26bis.3 to restore the right of priority has been granted.
Applicant may wish to file a petition under 37 CFR 1.55(c) to restore the right of priority if the subsequent application was filed within two months from the expiration of the twelve-month period and the delay was unintentional. A petition to restore the right of priority must include: (1) the priority claim under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) in an application data sheet, identifying the foreign application to which priority is claimed, by specifying the application number, country (or intellectual property authority), day, month, and year of its filing (unless previously submitted); (2) the petition fee set forth in 37 CFR 1.17(m)(3); and (3) a statement that the delay in filing the subsequent application within the twelve-month period was unintentional. The petition to restore the right of priority must be filed in the subsequent application, or in the earliest nonprovisional application claiming benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) to the subsequent application, if such subsequent application is not a nonprovisional application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
Accordingly, the effective filing date of the application is January 18, 2024 which is the filing date of the instant application.
Information Disclosure Statement
4. The listing of references in the specification in pages 3-4 is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
5. Claim 1 is objected to in reciting ‘but does not emit fluorescent.” It should recite ‘but does not emit fluorescence.” 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.
6. Claims 1, 4, and 7-17 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 1 in line 3 is vague and indefinite in reciting “concentrating locally” because “locally” as recited, is a subjective term lacking a comparative basis for defining its metes and bounds. See also claim 10.
Claim 1 in lines 3-6 is indefinite in reciting “concentrating locally the substance…, a material…, or a binding product…, and material… within a sample by electrophoresis or dielectrophoresis” because it is unclear as to whether the substance, material, binding product, and another material are each concentrated individually locally or should these components be combined in solution. Alternatively, it is further unclear how each of the substance and material or binding product and material would have been concentrated locally substantially as a whole if otherwise, not combined into a mixture. Please clarify.
Claim 1 is confusing in reciting “a binding product of the substance” in all occurrences in the claim because it is unclear what essential structural and/or functional cooperative relationship exists between the recitation of “a substance” and “a binding product of the substance.” How is it a binding product of the substance? Additionally, it appears that the specification fails to provide what Applicant intends to encompass in the term “binding product;” hence, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See also claim 8.
Claim 1 in line 8 is ambiguous in lacking clear antecedent basis in reciting “the substance to be detected” in all occurrences in the step because it is unclear as to whether “the substance” refers back to the “substance” in the preamble or “the substance” in line 3. Does Applicant intend “the concentrated substance?”
Claim 1 in lines 8-9 lacks clear antecedent basis and is confusing in reciting “a material for recognizing the substance… which is labeled with…” in all occurrences in the step because it is unclear what essential structural and/or functional cooperative relationship exists between the recitation of “a material” in line 3 and the instant “a material” in lines 8-9 other than being labeled with a fluorescent substance. Does Applicant intend the same material component that is being labeled or another separate material component that is labeled and having consonant affinity recognition? Please clarify.
Claim 1 in line 15 is also ambiguous in lacking clear antecedent basis in reciting “the substance to be detected” in all occurrences of the step because it is unclear as to whether “the substance” refers back to the “substance” in the preamble or “the substance” in line 3. Does Applicant intend “the concentrated substance?”
Claim 1 in lines 15-16 lacks clear antecedent basis and is confusing in reciting “a material for recognizing the substance… which is labeled with…” in all occurrences of the step because it is unclear what essential structural and/or functional cooperative relationship exists between the recitation of “a material” in line 3 and the instant “a material” in lines 15-16 other than being labeled with a fluorescent substance. Does Applicant intend the same binding molecule or affinity recognition?
Claim 1 in line 17 is confusing in reciting “a substance other than the substance” because it is unclear what essential structural and/or functional cooperative relationship exists between the “substance” and the “substance other than the substance.” In particular, the term “other” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. See also claim 7.
Claim 1, lines 15-22 is confusing in reciting “mixing the substance to be detected, a material for recognizing the substance to be detected which is labeled with a fluorescent substance that emits fluorescence at a specific wavelength, and the substance to be detected or a substance other than the substance to be detected which is recognized at the same site as the substance to be detected for the material for recognizing the substance to be detected, which is labeled with a fluorescent substance that fluoresces at a wavelength different from the specific wavelength or a quencher that absorbs fluorescence with the specific wavelength in the sample to bind the substance to be detected and the material for recognizing the substance to be detected” because it is unclear what Applicant intends in this mixing step. Please clarify.
Claim 1 in line 23 lacks clear antecedent basis and is ambiguous in reciting “measuring changes in fluorescence intensity of a binding product of the substance” because it is unclear how the instant “binding product” is detected and measured absent a label, much less a fluorescent substance, since the previous mixing steps do not appear to label the binding product.
Claim 1 in lines 23-29 is ambiguous in reciting “measuring changes in fluorescence intensity of a binding product of the substance … and the material for recognizing the substance …” and “confirming the presence of the substance… detected in the sample based on the measured fluorescence intensity, wherein the material for recognizing the substance… is labeled with a fluorescent substance that emits fluorescence at a specific wavelength and specifically recognizes and binds to the substance” because it implies but fails to clearly define that the fluorophore-labeled material recognizing the substance specifically binds the substance to generate a measurable fluorescence intensity and/or change thereof. In particular, there does not appear to be any binding interactions taking place in the first mixing and/or the second mixing step.
Claim 8 is ambiguous in reciting “a material … which is physically or chemically bound to a carrier particle, is further contained” because it is unclear what Applicant intends to encompass in the recitation of “contained.” Does Applicant perhaps intend “isolated?"
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claims 1, 4, and 7-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miyazaki et al. (WO 2021/070884 A1).
Miyazaki et al. teach the invention essentially as disclosed and claimed. Miyazaki et al. disclose a method for detecting a target substance (virus or bacteria) to be detected within a sample, comprising contacting the target virus or bacteria (i.e. target substance) with a material recognizing the target substance that recognizes and binds the target substance; in this case an antibody or an antigen binding fragment thereof (i.e. binding partner), wherein the antibody is specifically labeled with a fluorescent substance; locally concentrating the virus/bacteria, the fluorescent substance-labeled antibody, or a conjugate of the virus/bacteria and the labeled antibody (virus/bacteria - antibody complex) by electrophoresis or dielectrophoresis; mixing and binding the virus/bacteria, the labeled antibody, and the labeled conjugate formed by the binding of the virus/bacteria to the labeled antibody; detecting and measuring a change in fluorescence intensity (fluorescence spectrum) of the labeled virus/bacteria-antibody conjugate formed; and confirming the presence of the virus or bacteria on the basis of the measured fluorescence intensity (Abstract; [0016; 0025, 0032, 0033]).
Miyazaki et al. specifically teach that the target substance is a virus, a virus nuclear protein (nucleic acid, protein), or a single-stranded RNA [0017]. The target substance may also be an influenza-virus-derived nuclear protein (influenza-virus-derived substance [0017, 0020]. The target substance may be bound physically or chemically to a carrier particle; wherein the carrier particle is a metal fine particle, a metal oxide fine particle, a non-metal fine particle, a metal-coated resin fine particle, or a non-infectious spherical biological fine particle [0018, 0032-0034]. When the target substance is nucleic acid, the binding partner is a nucleic acid complementary to the nucleic acid [0022]. Miyazaki et al. specifically teach that the material recognizing the target substance that specifically binds the target substance is an antibody or an antibody fragment [0022, 0023] and that the fluorescent substance is a quantum dot [0031].
Miyazaki et al. teach that the target substance may be simultaneously mixed with an antibody or fragment thereof that recognizes and binds the target substance and which is labeled with a fluorescent substance that emits fluorescence at a specific wavelength and an antibody or fragment thereof that recognizes and binds the target substance and which is labeled with a different fluorescent substance that fluoresces at a wavelength distinct from the specific wavelength or a quencher that absorbs fluorescence at the specific wavelength so as to form sandwich complexes in the sample from which fluorescence intensity signal or change in fluorescence intensity is measured [0026-0028]. Miyazaki et al. further teach measuring changes in fluorescence intensity by inducing excitation of the fluorescent substance at the specific wavelength 1 so as to measure fluorescence intensity at wavelength 3, and the different fluorescent substance that fluoresces at a distinct wavelength absorbs at wavelength 2 and emits at wavelength 3. Miyazaki et al. also teach inducing excitation of the fluorescent substance at the specific wavelength 1 so as to measure its fluorescence emission intensity at wavelength 2 and the quencher that absorbs fluorescence of the specific wavelength is a fluorescent substance that absorbs at wavelength 2 but does not emit fluorescence at least in the specific measurement wavelength range [0029-0031, 0033]. See also Example 1 and Example 2.
Accordingly, Miyazaki et al. appears to read on Applicant’s claimed invention.
8. No claims are allowed.
Remarks
9. Prior art made of record are not relied upon but considered pertinent to the applicants' disclosure:
Kamoya et al. (JP 2002-174636- IDS) disclose a microorganism concentration measurement device and method comprising contacting and reacting a bacteria (target substance) with a fluorescent-labeled antibody (material recognizing the target substance that binds the target substance), and concentrating the bacteria by dielectrophoresis; measuring the fluorescence light intensity of the concentrated bacteria. Kamoya et al. teach that multiple simultaneous measurements can be made relative to multiple fluorescent labels [0011, 0012, 0021, 0022].
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/GAILENE GABEL/Primary Examiner, Art Unit 1678
August 25, 2026
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