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 .
Claim Status
Claims 1-18 are pending and examined on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: Claims 1 recites the abbreviation “cv.” Without first introducing the meaning of abbreviation. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Indefiniteness
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.
Claims 1-18 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 pre-AIA the applicant regards as the invention.
Claims 1, 14, and 16 recite, “the line” or “said line” without proper antecedent basis. Antecedent basis only exists for “the line” or “said line” in these claims if the word “cultivar”/”cv.” are intended to be used interchangeably. Even if that is the intention, the claims remain unnecessarily complicated. It is suggested that the word “line” be changed to “cv.” to overcome the rejections. Claims 2-13, 12, and 17-18 are rejected for depending from and indefinite claim and failing to recite additional limitations that would render the claim definite.
Claim 8 is drawn to a plant regenerated from the tissue culture of claim 6 where the regenerated plant expresses all of the characteristics of red leaf lettuce cv. Crimson Tide. The culture of claim 6 is made from iceberg variety Bison so it is unclear how it could regenerate a red leaf variety. Given this point of confusion, the metes and bounds of the claim cannot be determined.
Lack of Written Description
The following is a quotation 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.
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 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.
The claims are broadly drawn to products and methods requiring iceberg lettuce cv. Bison. Some claims are even more broadly drawn. F1 hybrids using Bison as one parent (claims 10-11) and plants produced by a method that comprises the step of introducing a transgene into Bison (claim 17). The claims do state that “a sample of seed of the line” were deposited under NCMA accession No. 202312098. There is no description of the generation of seed deposited, nor is there any of the uniformity/genetic stability of seeds of what can be considered cv. Bison.
Many plant growth characteristics can be highly influenced by environment. For example. Wurr et al 1992 (Journal of Horticultural Science 67:3, p. 395-401) studied environmental influences head diameter and head density (related to weight) in an iceberg-type lettuce named Saladin. They found that lower growth temperatures led to larger heads and denser heads while higher growth temperatures led to smaller less dense heads. Lafta 2021 (HortScience 56:2, p. 126-135) found in an evaluation of 25 different crisphead lettuce varieties that were previously identified as “heat-tolerant” that genetics and gene x environment interactions accounted for little of the variation and that environment alone was largely responsible for observed differences (Table 2). These traits include head weight, head diameter, and tipburn.
The instant disclosure describes provides a very limited phenotypic description of plants that are considered cv. Bison. Paragraph 28 states that Bison is a “vigorous” iceberg lettuce cultivar for winter production in Southern California and Western Arizona with a medium-large size with good weight that is resistant to tipburn and Fusarium wilt. Table 1 provides comparison of Bison with two check varieties. The only metrics reported are plant diameter, head diameter, and head weight. Additionally, Figure 1 shows the pedigree of Bison, but provides no basis of selections or identity of what genetic structures are coming from which parent.
These descriptions are insufficient, because the very limited trait descriptions fail to provide a means of assessment that would allow one of skill in the art to distinguish Bison from other materials. While The Office acknowledges that a sample of seed of line/cultivar Bison has been deposited, the very limited described traits which are known in the art as being influenced by environment would not even all a person of skill in the art know if the correct seed was given to the as the phenotypic traits described is so limited.
Given the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Deposit of Biological Material
This application requires public availability of specific biological material to make and use the claimed invention. A rejection under the appropriate sections of 35 USC 112 would have been made but for (1) evidence that the material is both known and readily available; (2) applicant’s statement in paragraph 100 on the specification filed 28 May 2024 indicating that an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 will be made with a recognized IDA, at or before the payment of the issue fee, in the event that the application should be determined to be allowable; or (3) an acceptable deposit of the specific biological material in compliance with the requirements under 37 CFR 1.801-1.809 has already been made. Because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801-1.809, applicants are advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW R KEOGH whose telephone number is (571)272-2960. The examiner can normally be reached M-Th 7-4:30, half day on Fridays.
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/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
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