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 .
Claim Status
Claims 1-24 are pending and examined.
Specification
The listing of references in the specification is not a proper information disclosure statement (e.g., see p. 39). 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 6 objected to for failing to include the NCIMB accession number which is present in all other claims.
Appropriate action is advised.
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 23 and 24 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 23 is drawn to a method of producing a modified tomato variety NUN 08605 TOF by mutating a target gene. The metes and bounds of the claim are indefinite because the claims lacks the deposit information and because the limitation “tomato variety NUN 08605 TOF” is not an art-recognized term such that one would not what is or is not encompassed by the claims.
Claim 24 is rejected for depending upon a rejected base claim and for failing to remedy the issues of indefiniteness.
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 1-24 are rejected under 35 U.S.C. 112(a) as containing 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.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a reproducible method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112.
Here, the specification fails to provide the breeding history for the claimed variety by omitting the parental lines used. Applicant provides proof of the deposited variety in the transmittal letter dated 09 August 2024.
However, the specification does not disclose a reproducible process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public.
If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent would satisfy the deposit requirement made herein.
A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number showing 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;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become unviable.
Applicant has not by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stated that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCMA Accession No. and evidence of deposit to overcome this rejection. Alternatively, Applicant may by way of affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, state that the seed will be irrevocably, and without restriction or condition, released to the public upon the issuance of a patent.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Claims 19 and 24 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 19 and 24 are drawn to a method of introducing single locus conversion in to tomato variety NUN 08605 TOF and wherein said plant comprises the single locus conversion and otherwise all of the characteristics of tomato variety NUN 08605 TOF, and a tomato plant produced by mutating a target gene in tomato variety NUN 08605 TOF.
The written description requirement may be satisfied through sufficient description of a representative number of species by disclosing relevant and identifying characteristics such as structural or other physical and/or chemical properties, by disclosing functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the invention as claimed. See Eli Lilly,119 F.3d at 1568, 43 USPQ2d at 1406.
The specification describes that tomato variety NUN 08605 TOF is a hybrid where its genome is heterologous at every locus (¶ 0179). The tomato genome possesses about 35,000 genes (e.g., see Pub. No. US 2024/0415127 A1, ¶ 0002).
Outcrossing of tomato variety tomato variety NUN 08605 TOF with an undisclosed parent and subsequent backcrossing to tomato variety NUN 08605 TOF will not regain all or most the morphological and physiological characteristics of tomato variety NUN 08605 TOF because of heterologous dominant and recessive alleles at every locus of the genome of the hybrid.
The specification has failed to describe a working example of a plant produced by the claimed method. While the specification describes that in the case of a hybrid gene may be introduced in the male or female parental line, the claims fail to recite the parental lines of tomato variety NUN 08605 TOF that would comprise said genes (¶ 0087).
This description is critical because the art fails to describe the introduction of a single locus conversion in to a hybrid plant by outcrossing and backcrossing to said hybrid plant to produce a converted plant having otherwise all the morphological and physiological characteristics of the hybrid plant.
While one skilled in the art can backcross a hybrid progeny to its hybrid parent, there is no description regarding the number of required backcrosses to the hybrid parent that are necessary to regain all of the morphological and physiological characteristics in addition to the single locus conversion.
With regard to the breeding history of tomato variety NUN 08605 TOF, MPEP 2402 provides that every patent must contain a written description of the invention sufficient to enable a person skilled in the art to which the invention pertains to make and use the invention. Where the invention involves a biological material and words alone cannot sufficiently describe how to make and use the invention in a reproducible manner, access to the biological material may be necessary for the satisfaction of the statutory requirements for patentability under 35 U.S.C. 112 [emphasis added].
As with other biological material deposited for purposes of patents for inventions under 35 U.S.C. 101, the deposit of plant material together with the written specification must enable those skilled in the art to make and use the claimed invention, in accordance with the requirements of 35 U.S.C. 112. See MPEP 2403.02.
MPEP 2163(I) also provides that "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1613. An application specification may show actual reduction to practice by describing testing of the claimed invention or, in the case of biological materials, by specifically describing a deposit made in accordance with 37 CFR 1.801 et seq. See Enzo Biochem, 323 F.3d at 965, 63 USPQ2d at 1614 ( "reference in the specification to a deposit may also satisfy the written description requirement with respect to a claimed material" ); see also Deposit of Biological Materials for Patent Purposes, Final Rule, 54 FR 34,864 (August 22, 1989) ("The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.).
Such a deposit is not a substitute for a written description of the claimed invention. The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985).
In the instant matter, the specification only provides a description of the traits of the variety but is silent and/or incomplete with respect to the breeding history of said variety. This breeding history is critical because it provides the genetics of the variety and, in turn, its corresponding traits. Thus, in the absence of a breeding history, the specification has failed to provide an adequate written description of the claimed variety.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant variety or cultivar. When identifying the breeding history, applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety.
For example, if Applicant’s breeding history uses proprietary line names, applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information.
Or, if the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, applicant should provide the breeding history of the parent line as well (i.e. grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Conclusion
No claim is allowed.
The closest prior art is Krivanek (Patent No. US 11,324,192 B1) which teaches tomato line SVTH3532 having many of the same characteristics of the instantly claimed variety (e.g., see Table 1). However, tomato line SVTH3532 does not have all of the same traits as the instantly claimed variety.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bratislav Stankovic can be reached at (571)270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662