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 .
Claims 1-8 and 11-14 are pending in this application.
35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
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 1-8 and 11-14 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 claims contain 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 1-8 and 11-14 were amended on 7/19/2024 to recite the biological materials Trichoderma harzianum strain RGM2218 and Clonostachys rosea strain RGM2217. The originally filed disclosure failed to provide descriptive support for these two strains. There was no information in the originally filed disclosure that reasonably conveyed the specific strains, T. harzianum strain RGM2218 and C. rosea strain RGM2217.
The originally filed disclosure did not contain any reference or information as to a specific strain of T. harzianum or a specific strain of C. rosea. There was no information whatsoever as to strain identification in the originally filed disclosure. Thus, even though inventors may have deposited a strain of T. harzianum with accession number RGM2218 and a strain of C. rosea with accession number RGM2217 at CChRGM on 6/24/20151, there was no originally filed disclosure that reasonably conveyed that the strains used in this application are the strains so deposited.
Applicant’s arguments filed on 9/29/2025 have been given due consideration but they were deemed unpersuasive for the following reasons.
Applicant argues that declarations filed by inventors, and certificates of deposits from CChRGM of RGM 2217 and RGM 2218 (deposit made in 2015), are evidence that “establishes possession at filing, and deposit references do not constitute new matter.” The Examiner cannot agree. Applicant fails to differentiate between actual possession and the written description that reasonably conveys possession to one skilled in the art. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560 (Fed. Cir. 1991); see also MPEP 2163.
In the present fact situation, even though Applicant argues actual possession, the originally filed disclosure failed to reasonably convey possession because there was no information whatsoever as to specific strains of Trichoderma harzianum and Clonostachys rosea. In this technology, specific strains are important because certain strains could exhibit difference in activity, property, or performance in specific environmental conditions and/or substrates. The originally filed disclosure provides no information as to the source of the strains, geography of the source, or molecular/genetic identification of T. harzianum strain TGM 2218 and C. rosea strain RGM 2217. MPEP 2163 clearly states, “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed.” In the present case, there was no description of the now-claimed strains, so the originally filed disclosure was not sufficient to permit verification that the deposited strains are in fact those disclosed in the originally filed disclosure.
Applicant argues that the specification discloses defined ratios, concentrations, methods of application, cultivation, inoculum preparation, formulations, and antagonism assays, but these disclosure do not reasonably convey that the strains used by Applicant are T. harzianum strain TGM 2218 and C. rosea strain RGM 2217.
Applicant argues that In re Lundak, 773 F.2d 1216 (Fed. Cir. 1985) “is directly on point” because the court held that “referencing a biological deposit is a permissible means to satisfy §112(a) for materials not fully reproducible from text alone, and that such a reference does not introduce new matter.” However, the original disclosure of the application that issued as U.S. Patent No. 4,594,325 in Lundak provided information and identification that were deemed sufficient because of the following details, for example (see the abstract and column 2 of the ‘325 patent):
- the subject cell line is characterized by being derived from the human lymphoblastoid B-cell line (B-LCL) designated as UC 729-6, which in turn was derived from the previously known and published cell line WI-L2; and
- the subject cell line is an Epstein-Barr virus transformed cell, is hypoxanthine phosphoribosyl transferase (HPRT) type deficient (6-thioguanine resistant), and expresses IgM with kappa light chains on both the surface and in the cytoplasm, and supernatants from the cell line are negative for IgA, IgD, IgG, and IgM.
- the subject cell line is referred to as WI-L2-729HF2 in the specification, and it is the same cell line that was deposited.
Therefore, the holding in Lundak does not support Applicant’s position, because the original disclosure in this application provided significantly less detail (i.e., virtually no detail) as to the now-claimed specific strains than in the original disclosure of the application that issued as US 4,594,325. The original disclosure of this application did not reasonably convey that Applicant had possession of the specific strains now claimed.
Applicant further argues that “It is particularly relevant that in the Second Office Action, the Examiner instructed Applicants to include deposit particulars. Thus, Applicant argues, “[t]o now treat this required information as impermissible new matter would be inconsistent.” The Examiner cannot agree. Applicant fails to mention that said Office action included this statement: “however, applicant is cautioned to avoid the entry of new matter (see below) into the specification by adding any other information.” (emphasis in the original). See page 5 of the Office action mailed on 10/17/2024. Furthermore, the same Office action consistently applied the same ground of rejection under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as here for failing to comply with the written description requirement. There is no inconsistency in requiring a deposit or deposit information when biological materials are essential to the claimed invention, and at the same time cautioning Applicant to avoid entry of new matter. Determination of sufficient descriptive support is fact based, so the Examiner could not determine whether the necessary deposit information is new matter until Applicant provided the necessary evidence in response to an Office action that raised the issue, i.e., the Office action of 10/17/2024 (the “Second Office action“ referenced by Applicant).
For these reasons, Applicant’s arguments are found unpersuasive, and this ground of rejection must be maintained.
New matter introduced by amendment
The amendment filed on 4/17/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
(1) Strain F1.A Trichoderma harzianum accession code RGM2218;
(2) Strain 24A Clonostachys rosea accession code RGM2217; and
(3) all deposit information pertaining to (1) and (2), supra.
As stated previously in this Office action, there was no originally disclosed identification of the specific strain that is (1) or (2), supra. Adding such information is adding new matter which is not supported by the original disclosure. The fact that the strains were deposited prior to the effective filing date of the instant application does not overcome this ground of objection because the original disclosure did not disclose or reasonably convey that said deposited strains are the strains used in this invention.
Applicant is required to cancel the new matter in the reply to this Office Action.
THIS ACTION IS MADE FINAL. 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 JOHN PAK whose telephone number is (571)272-0620. The Examiner can normally be reached on Monday to Friday from 8:30 AM to 5 PM.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner's SPE, Fereydoun Sajjadi, can be reached on (571)272-3311. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/JOHN PAK/Primary Examiner, Art Unit 1699
1 Deposit date of 6/24/2015 is more than 2 years before the filing date of the foreign priority application CL3480-2017, 12/27/2018, and more than 3 years before the filing date of the International application PCT/IB2018/060658, 12/27/2018,
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