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 .
Election/Restrictions
Applicant’s election of group III drawn to claim 3 in the reply filed on June 5, 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Status of the Claims
Claims 3 and 5-23 are pending.
Claims 3 and 5-23 are examined on the merits.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” “The disclosure relates”, etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Correction is required.
Claim Objections
Claims 3 and 8 are objected to because of the following:
In claim 3, “also” in the second line of the claim appears to be unnecessary and should be deleted to improve claim syntax.
In claim 8, “having all the physiological” in lines 1-2 of the claim appears to be missing “of” in between “all” and “the” and the claim should be amended to add this term. This modification would improve syntax and match the language used in claim 13.
Appropriate correction is requested.
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.
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 19-21 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.
Written Description (Lack of Breeding History)
Claims 3 and 5-23 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because the specification does not include a complete breeding history which makes clear the starting material and breeding steps used to produce the instant variety and this history is not found elsewhere in the disclosure.
Specifically, in the instant application, applicant has described the origins of the claimed variety as follows: “Tomato variety ‘X20-06’ was generated by an interspecific cross of S. lycopersicum and S. pimpinellifolium. The cross was done under controlled conditions in the research greenhouse of King Abdullah University of Science and Technology (KAUST), Thuwal, Saudi Arabia” (Specification, Page 83, Paragraph 0328). However, Applicant has not provided any description of the specific varieties of each species used in the cross nor has applicant provided a complete breeding history describing all of the breeding steps used to create the variety.
Applicant has provided a description of plant traits as seen in the specification (Pages 84-86 of the specification including table 3). As such the instant application is incomplete as to the complete breeding history used to produce the claimed plant variety.
The breeding history is incomplete because the specific pedigree and breeding history of the claimed plant line is not known in the art and a complete and clear breeding history is not provided in the Specification. The specification does use any other alternative means or description which provides the information on the genetics of the instant variety which would be conveyed through a complete breeding history and therefore the specification does not describe the genetic characteristics of the claimed variety.
Further, it is not clear whether the claimed tomato variety has any other synonyms or tradenames, and importantly, as noted above, what is the source of this plant line or the lines used to produce it. The breeding history must be clarified regarding synonyms, tradenames and the sources thereof as well as the specific steps taken to produce the instantly claimed line.
Applicant claims a new tomato variety and methods of producing the variety. This introduces a question of fact: what is an adequate written description of a tomato variety.
As the factfinder, the Examiner conducted a search of the relevant art which provided answers on what constitutes written description of a plant variety. A plant variety is defined by both its genetics (which are described in a 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 a specific and complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the exact 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 a complete and clear 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. 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 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).
As such claims 3 and 5-23 are rejected as lacking adequate written description.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3 and 5-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of US Patent US 12,239,091 B2 (hereafter ‘091) patented March 4, 2025 by Tester an inventor on the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because variety ‘MX20-06’ of ‘091 and instant variety ‘X20-06’ share or have similar values (+/- 10% std. dev.) for most of the traits disclosed for each variety (Instant Specification, Pages 84-86, Table 3; ‘091, Columns 54-55, Table 1).
Differences between variety ‘X20-06’ of the instant application and variety ‘MX20-06’ of ‘091 may be attributable to environmental variations, grader subjectivity, linkage drag during backcrossing, donor plant traits and/or statistical insignificance. Applicant admits there are minor variabilities among plants of variety ‘X20-06’ [0012]. Lastly, any morphological and physiological difference between these varieties needs to be unexpected and practically significant. See Ex Parte C (27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992)), Ex Parte McGowen (Application No. 14996093, P.T.A.B. Jun 15, 2020) and MPEP 716.02(b).
Applicant does not disclose an unexpected and practically significant difference in a trait between variety ‘X20-06’ of the instant application and variety ‘MX20-06’ of ‘091.
Additionally, Applicant does not provide a breeding history to describe the genetic characteristics of the claimed variety and therefore it is not possible to assess any genetic differences or similarities between the instant and reference varieties.
The plants, plant parts, cells, and methods of using variety ‘MX20-06’ of ‘091 are set forth in claim 1 and/or disclosed as obvious methods of using a tomato variety in the dependent claims and specification of ‘091.
Close Prior Art
This statement is provisional because the parents and breeding history of the instant variety have not been provided and therefore the genetics of the instant variety as can be described by a breeding history cannot be compared to the prior art and as such the following analysis relies on the morphological and phenotypic information provided on pages 83-86 of the specification including the trait table on pages 84-86 (Table 3).
The instantly claimed tomato variety appears to be free of the art for the following reasons:
The closest prior art appears to be found in US Patent Application Publication US 2021/0400904 A1, published December 30, 2021 with inventor Martinez.
The variety claimed in the prior art reference shares many characteristics with the instantly claimed variety including growth habit, stem anthocyanin coloration, stem internode length, leaf attitude, leaf length, leaf width, leaf blistering and flower color among many other characteristics. However, the varieties appear to differ in at least the following characteristics; plant height, type of leaf blade, leaflet size, intensity of leaf color, leaf flossiness, leaflet attitude, inflorescence type, pubescence of style and pedicel length among others. The parents and breeding history of the two varieties have not been compared.
Given these distinctions and the information provided on the instant variety it appears to be free of the art.
Conclusion
No claims are allowed.
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
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