DETAILED ACTION
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 1-18 are pending and examined on their merit herein.
Duty to Disclose
Applicant is reminded of their “Duty of Disclosure, Candor, and Good Faith” (see 37 C.F.R. § 1.56 and MPEP § 2001). Information that would be considered pertinent to patentability includes: 1) The plants utilized in the breeding programs that arrived at the two parental varieties crossed to produce the instant variety (meaning the grandparent varieties), as well as the specific breeding steps/techniques used to arrive at these parent varieties, 2) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed, 3) if parental varieties that were crossed to arrive at the instantly claimed variety were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/transgenes/traits were donated from the non-recurrent parent, 5) if there is a locus converted or multiple loci converted between the deposited seeds and the seeds grown to cross to produce the hybrid seeds used for the hybrid plants grown for the trait table in the specification, then Applicant should specify which loci were converted and which traits differ when compared to plants grown from the deposited seeds, 5) any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed. All of this information is material to patentability. If, for example, one of the parent plants is published but with a different name/designation, then the publication should be included in the IDS along with an explanation that the different name/designation is a synonym and how this plant is related to the instantly claimed plant.
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.
Claim 8 is 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 8 recites a lettuce plant has all of the physiological and morphological characteristics of red leaf lettuce cv. Crimson Tide, a sample of seed of the line having been deposited under NCMA Accession No. 202312101. As disclosed, the seeds deposited under NCMA Accession No. 202312101 are of iceberg lettuce cv. NNS-2117. It is not clear whether the claimed lettuce plant should have the traits of iceberg lettuce cv. NNS-2117 or red leaf lettuce cv. Crimson Tide. The metes and bounds are not clear.
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.
ENABLEMENT regarding Biological Deposit
Claims 1-18 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 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.
The invention appears to employ the seed of novel plants. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. The specification does not disclose a repeatable 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. In the instant case, the Specification has not explicitly stated that subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
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.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
WRITTEN DESCRIPTION
Claim 17 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 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant claims a plant produced by the method of claim 16, which is a method of producing a plant of iceberg lettuce cv. NNS-2117 with an added desired trait, comprising introducing a transgene conferring the desired trait into a plant of iceberg lettuce cv. NNS-2117, wherein a sample of seed of the line has been deposited under N CMA Accession No. 2 023 12101.
As indicated in the Specification, the introduction of a transgene may be done through backcrossing or genetic transformation, and a genetic locus may comprise one or more transgenes integrated at a single chromosomal location. See e.g., Specification at p. 2, [0008]; and p. 14, [0045]).
Applicant describes some physiological and morphological characteristics of the iceberg lettuce cv. NNS-2117 in Table 1 on page 7, and Table 2 on page 12 of the specification.
Applicant does not describe the genus of lettuce plants derived from lettuce cv. NNS-2117 comprising one or more transgenes, via introgression or transformation. The Specification permits any number of transgenes that may confer any number of morphological and/or physiological characteristics to the claimed plant. Applicant has failed to describe said genus.
It is well known in the art that genetic transformation and transgene could have pleiotropic effects on the development, morphology, or agronomic performance of the plant. For example, Latham (J Biomed Biotechnol. 2006: 25376.) teaches that transgene insertion is infrequently, if ever, a precise event. Mutations found at transgene insertion sites include deletions and rearrangements of host chromosomal DNA and introduction of superfluous DNA. Insertion sites introduced using Agrobacterium tumefaciens tend to have simpler structures but can be associated with extensive chromosomal rearrangements, while those of particle bombardment appear invariably to be associated with deletion and extensive scrambling of inserted and chromosomal DNA. Ancillary procedures associated with plant transformation, including tissue culture and infection with A tumefaciens, can also introduce mutations. These genome-wide mutations can number from hundreds to many thousands per diploid genome. (Abstract)
See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, which teaches that the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification. In this case, there is no way that a practitioner would be able to determine if any particular soybean plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Claim 17 is thus a “reach through” claim in which the Applicant has described a starting material and at least one method step, but has not described the resulting product; and wherein the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)). Accordingly, the specification fails to provide adequate written description to support the genus of plants produced by introducing any number of transgenes into the claimed iceberg lettuce cv. NNS-2117.
Conclusion
No claims are allowed.
Claims 1-18 are free of the prior art because there is no prior art reasonably teaching or suggesting the claimed lettuce variety.
The closet prior art is Sinclair (US 8692074 B2, 2014) which teaches an iceberg lettuce cultivar Denali. The prior art plant shares many physiological and morphological characteristics as the instant claimed lettuce variety, such as plant type, seed color, head shape, etc (Table 1). However, the prior art plant differs from the instantly claimed plant in at least the breeding history and genetic makeup.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663