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 without traverse of Group I, claim 1, in the reply filed on 11/17/2025 is acknowledged.
Claims 2-4 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/17/2025.
Information Disclosure Statement
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 1, it is apparent that the biological material, i.e. anti-mercury-ion monoclonal antibody, wherein the anti-mercury-ion monoclonal antibody is a monoclonal antibody secreted by a murine hybridoma cell strain 7A1, is required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 USC 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, may be satisfied by a deposit of the anti-mercury-ion monoclonal antibody and murine hybridoma cell strain 7A1.
The process disclosed in the specification does not appear to be repeatable, it is not clear that the invention will work with commonly available material and it is not apparent if the biological materials considered necessary to make and use the invention is both known and readily available to the public. Claim 1 is directed to a nanoflower immunochromatographic strip that requires an anti-mercury-ion monoclonal antibody; the anti-mercury-ion monoclonal antibody is a monoclonal antibody secreted by a murine hybridoma cell strain 7A1; and the murine hybridoma cell strain 7A1 has been preserved in the China General Microbiological Culture Collection Center, with a preservation address at No. 3, Yard 1. Beichen West Road, Chaoyang District, Beijing, a preservation date on Nov. 23, 2021 and a preservation number of CGMCC No. 23879. The specification provides preparation steps that requires the monoclonal antibody and the murine hybridoma cell strain 7A1, with the murine hybridoma cell strain 7A1 preserved in the CGMCCC (paragraphs [0006]-[0009], [0042]-[0043],[0049]). However, the disclosure does not state the conditions of the deposit and more particularly does not indicate that the deposited materials will be irrevocably released upon the allowance of the patent. One skilled in the art would recognize that it is not possible to make and/or use the nanoflower immunochromatographic strip as disclosed without access to the specific biological material anti-mercury-ion monoclonal antibody and murine hybridoma cell strain 7A1, because the required anti-mercury-ion monoclonal antibody and murine hybridoma cell strain 7A1 with desired affinity and specificity are generally difficult to obtain. Additionally, without a publicly available deposit of the anti-mercury-ion monoclonal antibody and murine hybridoma cell strain 7A1, one of ordinary skill in the art could not be assured of the ability to practice the invention as claimed, since replication of the disclosure would require the specific murine hybridoma cell strain 7A1. Therefore, the public has to be able to access the murine hybridoma cell strain 7A1 for one skilled in the art to perform the desired preparation steps to arrive at the nanoflower immunochromatographic strip with the proper affinity to mercury ions as disclosed.
It is noted that Applicants have deposited biological material in the CGMCCC but there is no indication in the specification as to public availability. Therefore, a deposit at a recognized depository may be made for to overcome this rejection.
If the deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit, that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
If the deposit is a non-Budapest Treaty deposit, then in order to certify that the deposit meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, a statement, affidavit or declaration by Applicant or by an attorney of record over his or her signature and registration number, or by someone in a position to corroborate the facts of the deposit would satisfy the requirements herein by stating and providing that:
(a) During the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) All restrictions upon availability to the public will be irrevocably removed upon granting of the patent;
(c) The deposit will be maintained in a public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer; and
(d) Provide evidence of the test of the viability of the biological material at the time of deposit (see 37 CFR 1.807).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (CN 103499688A; see machine translation) in view of Jia et al. (CN 112379088 A; see machine translation).
Regarding claim 1, Zhang teaches a immunochromatographic strip (Figs. 1-3; paragraph [0002]) for detecting heavy metal mercury ions (paragraphs [0002],[0011]), wherein the immunochromatographic strip comprises the following components:
a plastic outer shell (Figs. 1 and 3, paragraphs [0012],[0035], bottom support plate and outer card made of plastic), a sample pad (Fig. 1 and paragraphs [0012],[0035, sample pad 2), an immunoprobe joint pad (Fig. 1 and paragraphs [0012],[0035], gold-labeled antibody-binding pad 3), a nitrocellulose membrane (Fig. 1 and paragraphs [0012],[0035], nitrocellulose membrane 6), and an absorbent pad (Fig. 1 and paragraphs [0012],[0035], absorbent pad 5);
the immunoprobe joint pad (Fig. 1 and paragraphs [0012],[0035], gold-labeled antibody-binding pad 3) is dropwise added with a gold nano-immunoprobe labeled with an anti-mercury-ion monoclonal antibody (paragraphs [0012],[0024] teach the gold-labeled antibody-binding pad is coated, via spraying, with a colloidal gold-labeled monoclonal antibody that can recognize mercury ions; paragraph [0063] teaches gold nanoparticle test strips; note that “dropwise added” is interpreted as a product-by-process limitation, see MPEP 2113, wherein even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself);
the anti-mercury-ion monoclonal antibody is a monoclonal antibody (paragraphs [0012],[0024] the colloidal gold-labeled monoclonal antibody that can recognize mercury ions, i.e. monoclonal antibody) secreted by a murine hybridoma cell strain 7A1 (interpreted as a product-by-process limitation, see MPEP 2113, wherein determination of patentability is based on the product itself and the patentability of a product does not depend on its method of production, i.e. secreted by a murine hybridoma cell strain 7A1; paragraph [0022] teaches monoclonal antibody was prepared by secretion by hybridoma cells; thus, Zhang teaches a “monoclonal antibody”, which is the same as the claimed product; further note that “a murine hybridoma cell strain 7A1” is not positively recited structurally); and
the murine hybridoma cell strain 7A1 has been preserved in the China General Microbiological Culture Collection Center, with a preservation address at No. 3, Yard 1. Beichen West Road, Chaoyang District, Beijing, a preservation date on Nov. 23, 2021 and a preservation number of CGMCC No. 23879 (interpreted as a product-by-process limitation, see MPEP 2113, wherein determination of patentability is based on the product itself and the patentability of a product does not depend on its method of production, i.e. secreted by the murine hybridoma cell strain 7A1 as preserved; paragraph [0022] teaches monoclonal antibody was prepared by secretion by hybridoma cells; thus, Zhang teaches a “monoclonal antibody”, which is the same as the claimed product; further note that “a murine hybridoma cell strain 7A1” is not positively recited structurally).
Zhang fails to explicitly teach: the immunochromatographic strip is a nanoflower immunochromatographic strip.
Jia teaches a gold nano-flower fast detection test paper based on monoclonal antibody detecting heavy metal lead (abstract). Jia teaches known limitations of instrumental analysis for detection of heavy metals (paragraph [0005]). Jia teaches a need for improving sensitivity of existing lead colloidal gold immunochromatographic test strips (paragraph [0006]). Jia teaches flower-shaped gold nanoparticles, i.e. nanoflowers, exhibit a larger extinction coefficient due to their unique surface morphology, which can increase the sensitivity of immunoassay test strips by 10 times (paragraph [0006]). Jia teaches preparing a high-affinity and high-specificity monoclonal antibody, thereby achieving rapid and sensitive detection of Pb and effectively monitoring and controlling lead pollution (paragraph [0006]). Jia teaches the rapid test strip for detecting led residues in water using gold nanoflowers can be used for rapid and sensitive detection of lead ions (paragraph [0008]). Jia teaches a test strip includes an immunoprobe formed of anti-divalent lead ion monoclonal antibody hybridoma cell line 9B7 and gold nanoflowers, wherein the monoclonal antibody is secreted by a hybridoma cell line (paragraph [0009]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the immunochromatographic strip of Zhang to incorporate the teachings of colloidal gold immunochromatographic test strips that utilizes nanoflowers of Jia (paragraphs [0006],[0008]) to provide: the immunochromatographic strip is a nanoflower immunochromatographic strip. Doing so would have a reasonable expectation of successfully increase the sensitivity of the strip as taught by Jia (paragraph [0006]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tamura et al. (US 20070178544 A1) teaches antibodies capable of binding to a target substance and a highly sensitive immunoassay method using the antibodies (abstract). Tamura teaches cells were cloned from hybridomas 7A1 (paragraph [0093]). Tamura teaches murine hybridoma producing monoclonal antibodies were obtained and designated as 7A1, i.e. hybridoma 7A1 (paragraph [0099]).
Thalappil et al. (US 20150053868 A1) teaches composite materials comprising a mesoflower structure, methods of preparing the composite material, and methods of detecting heavy metal ion using the composite material (abstract). Thalappil teaches the mesoflower structure may have a size of about 500 nm (paragraph [0011]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758