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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/15/2026 has been entered. Claims 1-2 and 5 have been amended. Claims 1-5 are pending and are under examination.
Claim Rejections Withdrawn
The rejection of claims 1-5 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in view of the deposit of the hybridoma cell line producing rat anti-Erwinia 5E10 antibody and for the hybridoma cell line producing rat anti-Phytophthora 1C6 antibody under the Budapest Treaty and compliance with 37 CFR §1.801-1.809.
New Rejections
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.
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-4 are drawn to a simultaneous diagnosis method for Erwinia carotovora and Phytophthora infestans in a soil using semi-quantitative lateral flow immunoassay comprising wherein in the method rats are immunized using each of the species with Erwinia carotovora and Phytophthora infestans as antigens, after the species Erwinia carotovora and the species Phytophthora infestans are inactivated at a high temperature; splenocytes are extracted from the immunized rats; a hybridoma is prepared by cell-fusing the extracted splenocytes and myeloma cells (Sp2/0 Ag-18) at a ratio of splenocytes: myeloma cells of 5:1; monoclonal antibodies that are specific for the species Erwinia carotovora and the species Phytophthora infestans, respectively, and do not show cross-reactivity to bacteria Lactobacillus plantarum, Bacillus subtilis, Rhodobacter capsulatus, Saccharomyces cerevisiae, Bacillus velezensis, and Bacillus thuringiensis, and fungi Fusarium oxysporum, Mycosphaerella nawae, Rhizoctonia solani, and Colletotrichum gloeosporioides are obtained from the hybridoma; and
a rat anti-Erwinia 5E10 antibody and a rat anti-Phytophthora 1C6 antibody produced by the hybridoma are selected from the obtained antibodies
Claim 5 is drawn to a kit comprising the rat anti-Erwinia 5E10 antibody and a rat anti-Phytophthora 1C6 antibody produced by the respective hybridomas.
The claims are drawn to a genus of hybridomas that produce a rat anti-Erwinia 5E10 antibody and drawn to a genus of hybridomas that produce a rat anti-Phytophthora 1C6 antibody.
However, the only hybridomas described in the specification that produce these antibodies were deposited under the Budapest Treaty with Korean Cell line Research Foundation, Cancer Research Institute, Seoul National University College of Medicine and assigned Accession No. KCLRF-BP-00585 for the anti-Erwinia 5E10 antibody and assigned Accession No. KCLRF-BP-00584 for the anti-Phytophthora 1C6 antibody.
It is unpredictable that any other hybridoma will produce the anti-Erwinia 5E10 antibody assigned Accession No. KCLRF-BP-00585 and the anti-Phytophthora 1C6 antibody assigned Accession No. KCLRF-BP-00584.
Hybridomas are immortalized cells produced by fusing splenocytes that are isolated from antigen immunized animals with a myeloma cell, screening hybridoma clones and selection of a desired hybridoma that produces the monoclonal antibody.
For each of the antibodies only one type of hybridoma respectively is described for each of the 5E10 and IC6 antibodies. The disclosure of one hybridoma is insufficient to describe the genus of hybridomas that produces the 5E10 antibody and the disclosure of one hybridoma is insufficient to describe the genus of hybridomas that produces the 1C6 antibody. Multiple trials would be required to screen hybridomas made as described in the claimed methods or generally screen hybridomas made by any method for the kit of claim 5 to find the exact antibody that is produced by the hybridoma assigned Accession No. KCLRF-BP-00585 for the anti-Erwinia 5E10 antibody and the hybridoma assigned Accession No. KCLRF-BP-00584 for the anti-Phytophthora 1C6 antibody.
The courts have held that a sufficient number of representative species must be included “to demonstrate that the patentee possessed the full scope of the [claimed] invention." Lizardtech, Inc. v. Earth Resource Mapping, Inc. 424 F.3d 1336,1345, 76 USPQ2d 1724,1732 (Fed. Cir. 2005).
In the instant case, a representative number of hybridomas that produce the 1C6 monoclonal antibody and a representative number of hybridomas that produce the 5E10 monoclonal antibody that qualitatively represents the variation in each genus has not been described.
A patent specification should set forth enough detail to allow a person or ordinary skill in the art to understand what is claimed and to recognize that the inventor invented what is claimed. Enzo Biochem. Inc, v. Gen-Probe Inc.. 63 USPQ2d 1609 (Fed. Cir. 2002). It is the specification itself that must demonstrate possession. The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in the biological arts. See Ariad Pharmaceuticals. Inc, v. Eli Lilly and Co.. 94 USPQ2d 1161,1172, 1173 (Fed. Cir. 2010).
For these reasons Applicants as of the effective filing date of the instant invention were in possession of the hybridoma assigned Accession No. KCLRF-BP-00585 which secretes anti-Erwinia 5E10 antibody and the hybridoma assigned Accession No. KCLRF-BP-00584 which secretes anti-Phytophthora 1C6 antibody. Applicants as of the effective filing date of the instant invention were not in possession of the genus of hybridomas that produce the 5E10 antibody and the genus of hybridomas that produces the 1C6 antibody.
Applicant can obviate the instant rejection by including the deposited hybridoma assigned Accession No. KCLRF-BP-00585 which secretes anti-Erwinia 5E10 antibody and the deposited hybridoma assigned Accession No. KCLRF-BP-00584 which secretes anti-Phytophthora 1C6 antibody as the hybridomas producing the rat anti-Erwinia 5E10 antibody and the rat anti-Phytophthora IC6 antibody, respectively.
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 1-5 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 elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted elements are the accession numbers including place and date of deposit of the hybridoma producing rat anti-Erwinia 5E10 antibody and the accession number of the hybridoma cell line producing rat anti-Phytophthora 1C6 antibody.
The specification teaches under the section titled “Deposit of Biological Materials” that these hybridoma cell lines were deposited under the Budapest Treaty with Korean Cell line Research Foundation, Cancer Research Institute, Seoul National University College of Medicine and assigned Accession No. KCLRF-BP-00585 for the anti-Erwinia 5E10 antibody and assigned Accession No. KCLRF-BP-00584 for the anti-Phytophthora 1C6 antibody. These elements are essential because the accession numbers identify the hybridomas that produce antibodies with the laboratory designations 5E10 and IC6 assigned to the anti-Erwinia and anti-Phytophthora antibodies, respectively. The identification of the particular hybridomas by the accession numbers including place and date of deposit is a crucial element that serves to properly identify the source of the 5E10 and IC6 antibodies.
Status of Claims
Claims 1-5 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
