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, 4, 6, 9, 11 and 15 have been amended. Claims 5, 10, 12-14 and 16-20 have been cancelled. Claims 1-4, 6-9, 11 and 15 have been examined.
Information Disclosure Statements
The Information Disclosure Statement filed 08/03/2026 has been considered by the Examiner.
Claim Objections
Claim 15 is objected to because of the following informalities:
Claim 15 appears to have two preambles both stating what the reagent kit comprises.
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 4 and 9 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 4 is confusing because it states that the method further comprises claimed steps however it states “bringing an analyte in a sample” and it is unclear if the steps are intending to introduce a new analyte and sample or if the analyte and sample are the same as claimed in claim 1.
Claim 4 is indefinite because lines 3-4 recite “a solution” and it is unclear if this is a new solution or if this solution is intended to refer to the reaction mixture where the analyte and sample and anti-C3 antibody are initially combined.
Claim 9 is confusing because it states that the method comprises claimed steps however it states “bringing an analyte in a sample” and it is unclear if the steps are intending to introduce a new analyte and sample or if the analyte and sample are the same as claimed in claim 6.
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) 1-4, 6-9, 11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Osamu (JP2004325414 Pub Date: 11/18/2004, IDS, citations taken from Applicant-provided translation, previously cited) in view of Van der Donk et al. (WO2010/025756, hereinafter “Donk”).
Regarding claim 1, Osamu teaches a method for immunologically measuring an analyte in a sample (paragraph 0011) which comprises combining the analyte in a sample, a specific binding partner for the analyte, and an anti- C3 antibody in a reaction mixture; allowing an immunoreaction to occur between the analyte and specific binding partner; and detecting the immunoreaction to determine the amount of analyte in the sample, wherein the analyte does not react with the anti-C3 antibody (paragraphs 0019-0022).
While Osamu teaches that the anti-complement antibody present in the reaction system is not particularly limited and can include C3 and degradation products thereof (paragraph 0011), the reference fails to specifically teach that the anti-C3 antibody is any one or more selected from the group consisting of an anti-iC3b antibody, an anti-C3dg antibody, an anti-C3d antibody and an anti-C3b antibody.
Donk teaches throughout the publication a reaction vessel capable of detecting carrier bound analyte complexes (page 13, lines 15-17). More specifically, Donk teaches that a medium of the second compartment of the reaction vessel can also comprises at least one compound selected from antibodies including anti-C3c antibodies or anti-C3d antibodies, with the presence of these antibodies in the medium reinforcing the network of red blood cells before the actual complex forming or agglutination takes place (page 18, lines 7-22).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute, for the anti-C3c antibodies in the method of Osamu, anti-C3d antibodies as taught by Donk as one skilled in the art would have been motivated to make such a change as a mere alternative and functionally equivalent additional antibody and since the same expected reaction capabilities would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired reaction conditions and since Osamu is generic regarding the type of anti-CD3 antibody or degradation product used.
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 in view of Donk 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 the 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 an immunoreaction between the analyte and a specific binding partner for the analyte in the presence of an anti-C3 antibody, wherein the analyte does not react with the anti-C3 antibody (paragraphs 0017-0022).
While Osamu teaches that the anti-complement antibody present in the reaction system is not particularly limited and can include C3 and degradation products thereof (paragraph 0011), the reference fails to specifically teach that the anti-C3 antibody is any one or more selected from the group consisting of an anti-iC3b antibody, an anti-C3dg antibody, an anti-C3d antibody and an anti-C3b antibody.
Donk teaches throughout the publication a reaction vessel capable of detecting carrier bound analyte complexes (page 13, lines 15-17). More specifically, Donk teaches that a medium of the second compartment of the reaction vessel can also comprises at least one compound selected from antibodies including anti-C3c antibodies or anti-C3d antibodies, with the presence of these antibodies in the medium reinforcing the network of red blood cells before the actual complex forming or agglutination takes place (page 18, lines 7-22).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute, for the anti-C3c antibodies in the method of Osamu, anti-C3d antibodies as taught by Donk as one skilled in the art would have been motivated to make such a change as a mere alternative and functionally equivalent additional antibody and since the same expected reaction capabilities would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired reaction conditions and since Osamu is generic regarding the type of anti-CD3 antibody or degradation product used.
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 in view of Donk 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 11, Osamu teaches an immunoassay reagent comprising an anti-C3 antibody and latex particles carrying a specific binding partner for an analyte, wherein the analyte does not react with the anti-C3 antibody (paragraphs 0011 and 0017-0019).
While Osamu teaches that the anti-complement antibody present in the reaction system is not particularly limited and can include C3 and degradation products thereof (paragraph 0011), the reference fails to specifically teach that the anti-C3 antibody is any one or more selected from the group consisting of an anti-iC3b antibody, an anti-C3dg antibody, an anti-C3d antibody and an anti-C3b antibody.
Donk teaches throughout the publication a reaction vessel capable of detecting carrier bound analyte complexes (page 13, lines 15-17). More specifically, Donk teaches that a medium of the second compartment of the reaction vessel can also comprises at least one compound selected from antibodies including anti-C3c antibodies or anti-C3d antibodies, with the presence of these antibodies in the medium reinforcing the network of red blood cells before the actual complex forming or agglutination takes place (page 18, lines 7-22).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute, for the anti-C3c antibodies in the method of Osamu, anti-C3d antibodies as taught by Donk as one skilled in the art would have been motivated to make such a change as a mere alternative and functionally equivalent additional antibody and since the same expected reaction capabilities would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired reaction conditions and since Osamu is generic regarding the type of anti-CD3 antibody or degradation product used.
Regarding claim 15, Osamu teaches an immunoassay reagent kit comprising an anti-C3 antibody (paragraphs 0011 and 0017), wherein 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, wherein the analyte does not react with the anti-C3 antibody (paragraphs 0017-0020).
While Osamu teaches that the anti-complement antibody present in the reaction system is not particularly limited and can include C3 and degradation products thereof (paragraph 0011), the reference fails to specifically teach that the anti-C3 antibody is any one or more selected from the group consisting of an anti-iC3b antibody, an anti-C3dg antibody, an anti-C3d antibody and an anti-C3b antibody.
Donk teaches throughout the publication a reaction vessel capable of detecting carrier bound analyte complexes (page 13, lines 15-17). More specifically, Donk teaches that a medium of the second compartment of the reaction vessel can also comprises at least one compound selected from antibodies including anti-C3c antibodies or anti-C3d antibodies, with the presence of these antibodies in the medium reinforcing the network of red blood cells before the actual complex forming or agglutination takes place (page 18, lines 7-22).
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to substitute, for the anti-C3c antibodies in the method of Osamu, anti-C3d antibodies as taught by Donk as one skilled in the art would have been motivated to make such a change as a mere alternative and functionally equivalent additional antibody and since the same expected reaction capabilities would have been obtained. The use of alternative and functionally equivalent techniques would have been desirable to those of ordinary skill in the art based on the desired reaction conditions and since Osamu is generic regarding the type of anti-CD3 antibody or degradation product used.
Response to Arguments
Applicant’s brief arguments filed 05/21/2026 have been considered but are found to be moot in view of the new grounds of rejection applied to the newly amended claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA M GIERE/ Primary Examiner, Art Unit 1677
Prosecution Insights