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
Claims 1-20 are pending and have been examined.
Priority
This application, Serial No. 18/273,153 (PGPub: US2024/0302366) was filed 07/19/2023. This application is a 371 of PCT/JP2022/002518 filed 01/25/2022. This application claims priority to Foreign Application Japan 2021-010184 filed 01/26/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)- (d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statements
The Information Disclosure Statements filed 07/19/2023, 10/06/2023, 01/10/2025, 08/04/2025, 09/05/2025, 12/12/2025 and 01/16/2026 have been considered by the Examiner.
Claim Objections
Claim 18 is objected to because of the following informalities:
Claim 18 states “the immunoassay reagent according…” and should be corrected to include “immunoassay reagent kit” to avoid confusion with the immunoassay reagents of claims 11-14.
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 1-10 and 15-18 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 is indefinite because it recites a method for immunologically measuring an analyte in a sample comprising conducting immunoreaction but fails to make clear how the analyte is actually being measured.
Claim 1 is also indefinite because it recites measuring an analyte by conducting immunoreaction in the presence of an anti-C3 antibody but it is unclear what the binding relationship is between the anti-C3 antibody and the analyte such that an immunoreaction in the presence of anti-C3 antibody would allow for measuring the analyte.
Claim 6 is indefinite because it states “non-specific reaction” but the claim has only mentioned an analyte and an anti-C3 antibody, with no link between the two to then identify what type of non-specific reaction is intending to be suppressed.
Claim 6 is also confusing because it is unclear if the method for suppressing itself comprises conducting immunoreaction in the presence of an anti-C3 antibody or alternatively if the claim has failed to incorporate any active method steps and the “conducting immunoreaction in the presence of an anti-C3 antibody” is referring for the method for measuring an analyte in a sample.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 12-13 and 16 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 12-13 do not further limit the reagent of claim 11 since claim 12 recites an intended use of the reagent of claim 11 with no limiting structure included. Similarly for claim 13, while reciting a latex immunoagglutination, the claim fails to specifically limit claim 11 by claiming the latex particles or the like.
Claim 16 does not further limit the kit of claim 15 since claim 16 recites an intended use of the kit of claim 15 with no limiting structure incorporated.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claim(s) 1-2, 5-7, 10-12, 14 and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Olson et al. (US 2012/0141457 Pub Date: 06/07/2012, IDS).
Regarding claim 1, Olson teaches throughout the publication a immunoassay method for immunologically measuring an analyte in a sample comprising conducting immunoreaction in the presence of an anti-C3 antibody (paragraphs 0021, Tables 1-2 and more specifically, paragraph 0143).
Regarding claim 2, Olson teaches the method wherein the method is a homogeneous method (paragraph 0143, lateral flow).
Regarding claim 5, Olson teaches the method wherein the anti-C3 antibody is anti-iC3b antibody or an anti-C3d antibody (see Table 1 and Table 2).
Regarding claim 6, Olson teaches a method for suppressing non-specific reaction in an immunoassay method for measuring an analyte in a sample immunologically, comprising conducting immunoreaction in the presence of an anti-C3 antibody (paragraph 0018 – avoid interfering cross-talk; paragraph 0021, Tables 1-2 and paragraph 0143).
Regarding claim 7, Olson teaches the method wherein the immunoassay method is a homogeneous method (paragraph 0143, lateral flow).
Regarding claim 10, Olson teaches the method wherein the anti-C3 antibody is anti-iC3b antibody or an anti-C3d antibody (see Table 1 and Table 2).
Regarding claim 11, Olson teaches an immunoassay reagent comprising an anti-C3 antibody (See Tables 1-2; paragraph 0143).
Regarding claim 12, Olson teaches the immunoassay reagent wherein a method of the immunoassay is a homogeneous method (paragraph 0143, lateral flow).
Regarding claim 14, Olson teaches the reagent wherein the anti-C3 antibody is anti-iC3b antibody or an anti-C3d antibody (see Table 1 and Table 2).
Regarding claim 19, Olson teaches an agent for suppressing non-specific reaction (paragraph 0018) in an immunoassay method comprising an anti-C3 antibody as an active ingredient (paragraph 0104 and Tables 1-2).
Regarding claim 20, Olson teaches the agent wherein the anti-C3 antibody is anti-iC3b antibody or an anti-C3d antibody (see Table 1 and Table 2).
Claim(s) 1-4, 6-9, 11-13, 15-17 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osamu (JP2004325414 Pub Date: 11/18/2004, IDS, citations taken from Applicant-provided translation).
Regarding claim 1, Osamu teaches a method for immunologically measuring an analyte in a sample comprising conducting immunoreaction in the presence of an anti-C3 antibody (paragraph 0011).
Regarding claim 2, Osamu teaches the method wherein the method is a homogeneous method (paragraphs 0019-0022)
Regarding claim 3, Osamu teaches the method wherein the homogeneous method is a latex immunoagglutination measurement method (paragraphs 0007-0008 and 0022).
Regarding claim 4, Osamu teaches the method comprising bringing an analyte in a sample and the anti-C3 antibody into contact with each other in a solution, adding latex particles carrying a specific binding partner for the analyte to the solution and optically detecting the degree of agglutination of the latex particles in the solution (paragraphs 0019-0022).
Regarding claim 6, Osamu teaches a method for suppressing non-specific reaction in an immunoassay method (paragraph 0015) for measuring an analyte in a sample immunologically, comprising conducting immunoreaction in the presence of an anti-C3 antibody (paragraphs 0019-0022).
Regarding claim 7, Osamu teaches the method wherein the immunoassay method is a homogeneous method (paragraphs 0019-0022).
Regarding claim 8, Osamu teaches the method wherein the homogeneous method is a latex immunoagglutination measurement method (paragraphs 0007-0008 and 0019-0022).
Regarding claim 9, Osamu teaches the method comprising bringing an analyte in a sample and an anti-C3 antibody into contact with each other in a solution, adding latex particles carrying a specific binding partner for the analyte to the solution and optically detecting the degree of agglutination of the latex particles in the solution (paragraphs 0019-0022).
Regarding claim 11, Osamu teaches an immunoassay reagent comprising an anti-C3 antibody (paragraphs 0011 and 0019).
Regarding claim 12, Osamu teaches the immunoassay reagent wherein a method of the immunoassay is a homogeneous method (paragraphs 0019-0022).
Regarding claim 13, Osamu teaches the reagent wherein the homogeneous method is a latex immunoagglutination measurement method (paragraphs 0007-0008 and 0019-0022).
Regarding claim 15, Osamu teaches an immunoassay reagent kit comprising an anti-C3 antibody (paragraphs 0011 and 0017).
Regarding claim 16, Osamu teaches the reagent kit wherein a method of the immunoassay is a homogeneous method (paragraphs 0019-0022).
Regarding claim 17, Osamu teaches the kit wherein the homogeneous method is a latex immunoagglutination measurement method (paragraphs 0007-0008), and the immunoassay reagent kit comprises: (1) a first reagent containing the anti-C3 antibody; and (2) a second reagent containing latex particles carrying a specific binding partner for an analyte (paragraphs 0017-0020).
Regarding claim 19, Osamu teaches an agent for suppressing non-specific reaction (paragraph 0015) in an immunoassay method comprising an anti-C3 antibody as an active ingredient (paragraphs 0019-0022).
Claim(s) 11-12, 14-16 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Battrell et al. (US 2010/0112723).
Regarding claim 11, Battrell teaches an immunoassay reagent comprising an anti-C3 antibody (paragraph 0235).
Regarding claim 12, Battrell teaches the immunoassay reagent wherein a method of the immunoassay is a homogeneous method (paragraph 0235).
Regarding claim 14, Battrell teaches the reagent wherein the anti-C3 antibody is an anti-C3d antibody (paragraph 0235).
Regarding claim 15, Battrell teaches an immunoassay reagent kit comprising an anti-C3 antibody (paragraph 0221).
Regarding claim 16, Battrell teaches the reagent kit wherein a method of the immunoassay is a homogeneous method (paragraphs 0216 and 0221).
Regarding claim 18, Battrell teaches the immunoassay reagent wherein the anti-C3 antibody is an anti-C3d antibody (paragraph 0221).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Troldborg et al. (Journal of Immunological Methods 486, 2020, 112866, pages 1-9) teaches a sandwich immunoassay comprising a capture anti-C3dg antibody (see page 4, section 3.1).
Zhang et al. (US 2012/0135430) teaches a method of determining the concentration of iC3b in plasma or serum samples (paragraph 0125) as well as an assay preparation comprising a capture antibody of anti-C3d antibody (paragraph 0146).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677