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 .
Status of Objections and Rejections
1. Claims 1-23 are pending. Accordingly, claims 1-23 are examined on merits in the present Office action.
2. Objection to the specification is withdrawn in light of amendments to the specification filed in the papers of June 22, 2026.
3. Objection to claims 1, 9, 13, and 19-23 is withdrawn in light of amendments to the claims filed in the papers of June 22, 2026, and upon further consideration.
4. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
5. Rejection of claims 1-23 under 35 U.S.C. 112(b) is withdrawn in light of amendments to the claims filed in the papers of June 22, 2026, and upon further consideration.
6. Rejection of claims 1-23 under 35 U.S.C. 112(a) as failing to comply with the enablement requirement is withdrawn in light of amendments to the claims, Applicant’s arguments filed in the papers of June 22, 2026, and upon further consideration.
7. Rejection of claim 15 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112 (a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in light of amendments to the claim, Applicant’s arguments filed in the papers of June 22, 2026, and upon further consideration.
Claim Objections
8. Claims 3 and 6 are objected to because of the following informalities:
Applicants are advised that should Claim 2 be found allowable, Claim 3 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k). In the instant case, claim 3 falls within the scope of claim 2. Claim 2 and claim 3 are directed to a plant grown from the same seed which is deposited under NCIMB Accession No. 44772.
It is noted that claim 6 is improperly dependent on claim 5. It is suggested to make it dependent on claim 4 for proper antecedent basis.
Claim Rejections - 35 USC § 112 (Written Description- Lack of Breeding History)
9A. Claims 1-23 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 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 for the reasons of record stated in the Office action mailed March 23, 2026
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new wild rocket variety SIMLOPS. So, the examiner will evaluate what is an adequate written description for a new wild rocket variety SIMLOPS. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in tables 1 and 2. However, there is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
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 (UPOV, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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.
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 et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 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 to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
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).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete 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 complete 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.
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/drawing to provide the breeding history used to develop the instant variety. 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 and all other potential names for the claimed variety. If Applicant’s breeding history uses proprietary variety names, Applicant should notate in the specification all other names of the proprietary varieties, especially publicly disclosed or patented variety 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 should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is 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). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant’s attention is drawn to the paragraph [0042] at page 8 of the specification which says:
[0042] “A detailed description of the development of wild rocket variety SIMLOPS is described in Table 1 and deposited with the NCIMB under deposit number 44772.”
However, it is noted that Table 1 only describes characteristics of SIMLOPS in comparison with a commonly known variety “Nature”.
Applicant included no breeding history for wild rocket variety SIMPLOS in the specification. No additional names for all parent(s) involved in creating wild rocket variety SIMPLOS is disclosed in the specification. This disclosure is insufficient or missing because it does not address all the issues set forth above.
Thus, the breeding history for the claimed variety as disclosed in the Specification is missing. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed wild rocket variety SIMPLOS. It must be noted that there is natural variation in wild rocket plant caused by genetics and environment. Additionally, the specification at paragraph [0073] states the term “wild rocket variety SIMPLOPS” includes any locus incorporated in the variety during backcrossing, and said plant has essentially all the morphological and physiological characteristics of the variety [see paragraphs [0028]-[0029]. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of Wild rocket plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed variety, including all names for the parents and for the claimed variety, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
9B. Response to Applicant’s arguments:
Applicant argues that paragraph [0037] has been amended to provide additional breeding history information and that disclosure of the internal designations or codes of the parental lines is unnecessary because the parental lines are proprietary, are not publicly known by other names, and have not been disclosed in patents.
However, the rejection is not based solely on the absence of parental line designations. Rather, the rejection is based on the absence of a complete breeding history sufficient to reasonably convey possession of the claimed plant variety. As explained in the Office Action, the Examiner established a reasonable factual basis that breeding history constitutes part of the minimum information ordinarily relied upon to describe and distinguish a newly developed plant variety. The Office Action cited multiple sources demonstrating that parentage, breeding methodology, and developmental history are routinely used in the evaluation and characterization of plant varieties.
Applicant has not substantively addressed the Examiner’s factual findings regarding the importance of breeding history in characterizing a plant variety. Nor has Applicant presented evidence that one of ordinary skill in the art would consider the presently disclosed information alone—consisting primarily of morphological and physiological characteristics together with a deposit—to be sufficient to demonstrate possession of the full scope of the claimed invention.
The deposit and phenotypic description do not remedy the deficiency identified in the rejection. As explained in the Office Action, phenotypic characteristics alone do not necessarily establish the identity of a plant variety because plant populations exhibit both genetic and environmental variation. Furthermore, the claims are not limited to the deposited seed itself. The specification expressly states that the claimed variety encompasses plants containing additional loci incorporated through backcrossing while retaining essentially all morphological and physiological characteristics of the variety. Thus, the claims encompass plants that may differ genetically from the deposited material.
Because the claims encompass a broader genus of plants than the deposited seed alone, information concerning the developmental history of the claimed variety remains material to determining the boundaries of the invention and to evaluating whether Applicant possessed the full scope of the claimed subject matter at the time of filing.
Applicant additionally contends that disclosure of internal parental designations would not provide relevant information to a person of ordinary skill in the art. The Examiner does not agree. Even if parental lines are proprietary and have not been publicly disclosed, information concerning the parentage, breeding methodology, recurrent parent(s), donor parent(s), selection history, and generation history remains relevant to understanding the genetic development of the claimed variety. The rejection specifically requested breeding-history information because such information provides genetic context that cannot be obtained solely from phenotypic descriptions or from a seed deposit.
Applicant has not demonstrated that the amended disclosure now contains a complete breeding history identifying the developmental pathway used to create the claimed variety. Nor has Applicant demonstrated that the information omitted from the specification is unnecessary to satisfy the written description requirement for the full scope of the claimed invention.
It is important to note that (i) Written description requires demonstrating possession of the claimed structure; (ii) Description by function alone (or by phenotype alone) is not sufficient; and (iii) A genus must be supported by a representative number of species or by identifying common structural features. See Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc).
In the instant case, the claimed wild rocket variety SIMPLOPS is defined solely by (1) a name, (2) a deposit number, and (3) a phenotypic trait table. The specification contains: (a) No breeding history; (b) No parental information; (c) No structural description of the genotype; and (d) No description of how the claimed variety arises from its antecedent structure. Because wild rocket varieties are known to exhibit intracultivar genetic heterogeneity, the absence of a structural description (i.e., breeding history and genetic origin) prevents a skilled person from determining what structural features define the claimed variety. This is precisely the type of defect that the Federal Circuit warned of in Eli Lilly and subsequent cases. A deposit does not provide structural information in the specification, and therefore cannot satisfy written description whereas here the claimed organism is a plant variety that is routinely described by pedigree and genetic origin. Applicant therefore has not demonstrated possession.
Also see Pioneer Hi-Bred Int’l v. Holden Foundation Seeds, Inc., 35 F.3d 1226 (8th Cir. 1994). Although Pioneer addressed trade secret issues, the court’s observations are directly relevant: (i) Plant varieties cannot be reliably identified or distinguished by phenotype alone; (ii) Genetically different lines may exhibit indistinguishable phenotypes; (iii) Environmental conditions may mask or alter phenotypic traits; and (iv) The true identity of a plant variety lies in its genetic composition, not merely in observable characteristics. The Pioneer court emphasized that the genotype—not phenotype—defines a plant line. This directly supports the Examiner’s position: a seed deposit and phenotypic table do not establish written description because the specification still lacks structural description demonstrating possession of the claimed wild rocket variety SIMPLOPS.
Accordingly, Applicant’s arguments are not persuasive and do not overcome the Examiner’s showing that the original disclosure fails to provide an adequate written description of the claimed plant variety. Therefore, the rejection of claims 1–23 under 35 U.S.C. § 112(a) is maintained.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
10. Claims 1-23 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-23 of copending Application No. 19/033,043. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
The wild rocket variety “SICARIUS” (see tables 1 and 2) of US Patent Application No. 19/033,043 (‘043 thereafter) shares all the characteristics with the instant wild rocket variety “SIMLOPS”. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Although copending ‘043 application designates the claimed wild rocket variety as “SICARIUS” and the instant wild rocket variety designated as “SIMLOPS”, however both shares the same characteristics, unless Applicant provides evidence to contrary through breeding history and additional genetic and molecular data.
Should Applicant’s response provide some additional evidence that may overcome statutory type (35 U.S.C. 101) double patenting rejection, however it must be noted the claims would be still rejected under non-statutory type of obvious type rejection which can only be overcome by filing relevant terminal disclaimer.
Conclusions
11. Claims 1-23 remain rejected.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Vinod Kumar whose telephone number is (571)272-4445. The examiner can normally be reached on 8:30 am - 5.00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. Abraham can be reached on (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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/VINOD KUMAR/ Primary Examiner, Art Unit 1663
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