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 1-20 are pending.
Claims 6-8, 15 and 19 are newly amended.
Claims 1-20 are rejected.
Claim Objections
Claim 6 is newly objected to because of the following informalities: Claim 6 was amended to remove the recitation of “essentially all” in the first line of the claim, removing that recitation produces a claim which reads “A maize plant having of the physiological and morphological characteristics of the plant”, “of” should be removed from the first line of amended claim 6. Appropriate correction is required.
Response to Applicant Arguments – Specification
In response to Applicant’s amendments to the specification dated 02/04/2026, the objections to the specification of record are withdrawn. However, applicant’s amendment to the specification requires a new objection.
Specification
The disclosure is newly objected to because of the following informalities: in the breeding history there are several references to inbred line B73, however in the fifth line of the breeding history paragraph on page 2 of the amended specification there is a recitation of “B37” which appears to be a typographical error.
Appropriate correction is required.
Response to Applicant Arguments – 35 USC § 112 (Indefiniteness)
In response to Applicant’s arguments and amendments to the specification dated 02/04/2026, the indefiniteness rejections of record are withdrawn.
Response to Applicant Arguments – 35 USC § 112 (Enablement)
In response to Applicant’s arguments and amendments to the specification dated 02/04/2026, the enablement rejections of record are withdrawn.
Response to Applicant Arguments – 35 USC § 112 (Written Description)
In response to Applicant’s arguments and amendments to the specification dated 02/04/2026, the written description rejections against claims 6-8 and 16 on the grounds of an inadequately described broad genus of variants are withdrawn.
With respect to the written description rejections of record on the grounds of a lack of breeding history, applicant’s arguments dated 02/04/2026 that the specification has been amended to include a breeding history are not found to be persuasive. The office appreciates applicant providing a breeding history for the claimed variety. However, while applicant has provided a breeding history it does not appear to be complete and it is not clear if this breeding history applies to the instant variety.
Specifically, applicant provides a chronology of the inbreeding of the instant variety which begins with an initial cross which was made in 2012, the F1 progeny of this cross were self-pollinated to create a F2 bulk population in 2013, then the F2 underwent haploidization and then the haploids were doubled and bulked in winter 2013/summer 2014, then in winter 2014, winter 2016, and summer 2017 the line was self-pollinated and finally in winter 2017 the line was bulked to produce breeder seed of the claimed inbred line. This is clear and helpful, however while this breeding history begins with an initial cross in the Breeding History section on page 2 of the amended specification dated 02/04/2026, applicant’s only provide a single parent. While the office appreciates applicant providing a detailed history on the origins of this parent it appears that either the information on the second parent was not provided or instead that the breeding history of the single parent provided does not align to the chronology of inbreeding provided on page 3 of the amended specification dated 02/04/2026. Therefore, because the detailed breeding history provided in the amendment to the specification does not appear to be complete, applicant has not adequately described the genetic characteristics of the claimed variety and applicants arguments are not found to be persuasive and claims 1-20 remain rejected as lacking adequate written description.
Claim Rejections - 35 USC § 112(a) (Written Description)
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.
Written Description (Lack of Breeding History)
Claims 1-20 remain 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because the breeding history included in the disclosure is incomplete.
Specifically, in the instant application, applicant has provided a helpful and detailed history of one parent but fails to provide information on the other parent. Further, applicant has provided a chronology of inbreeding which states that the instant variety was produced from an initial cross made in the winter of 2012, which makes clear that there are two parents of the claimed variety, even though information has been provided on only one of them. Additionally, applicant has provided a description of the plant traits as seen in the specification. The instant application is incomplete as to the full breeding history used to produce the claimed plant variety.
The breeding history is incomplete because the complete pedigree of the plant line is not known in the art and not provided in the Specification, given that there is no description of the second parent of the claimed variety. It is not clear whether JRFF6809 has any other synonyms or tradenames, nor what is the source of this plant line or the second parental line used to produce it. The breeding history must be clarified regarding synonyms, tradenames and the sources thereof.
In the instant application, Applicant claims a new plant variety and methods of producing the variety. This introduces a question of fact: what is an adequate written description of a plant variety.
In searching for an answer to the above question of fact, a search of the relevant art provided answers on what constitutes written description of a plant variety. A plant variety is defined by both its genetics (which are described in the breeding history) and its traits. The following are presented as a review of the state of the art with respect to the question of fact presented above; what is written description of a plant. The following is not presented as a legal basis for the rejection.
In plant breeding, a breeding history is considered critical in describing a variety and assessing the intellectual property rights of a plant. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”. Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection” by the USDA, Exhibit A). Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (See UPOV EDV Explanatory Notes, 14 and 30). While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety. (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen- Board Decision in Application 14/996,093). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification lacking a breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun, Page 645, left column). Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation. (See Haun, Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky, page 5430 left column 1st full paragraph and right column 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, applicant must amend the specification/drawings to provide the complete breeding history used to develop the instant variety or cultivar (Emphasis added). 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. 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).
Of interest the MPEP notes that in addition to demonstrating that the applicant is in possession of the claimed invention that the disclosure should have several other characteristics as follows:
MPEP 2163 (I) states “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); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “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.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
Closest Prior Art
Applicant has not provided a complete breeding history which as noted in the written description rejection above is required for a complete search of the instant invention. Therefore, this is a provisional statement of prior art as only the phenotypic characteristics of the claimed plant can be searched without the genetic information provided in a breeding history.
The instantly claimed invention appears to be free of the prior art. The closest prior art is found in De Dreu, (US Publication US 2021/0337759 A1, published November 4, 2021)9795108), which teaches variety corn line GIE2002. The instantly claimed corn line shares many traits with GIE2002 but differs in silk color. The two varieties also have a slight difference in glume color with the instant variety having green glumes while the reference variety has green glumes with slightly red color. Thus the varieties appear to be distinct.
Conclusion
Claims 1-20 remain rejected.
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.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
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 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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/BRIAN JAMES SULLIVAN/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663