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 .
Information Disclosure Statement
The Information Disclosure Statements filed on 3/4/2026, 6/5/2026 have been entered and considered. Initialed copies of the form PTO-1449 are enclosed with this action.
Status of claims
Applicant’s response filed 6/5/2026 has been entered.
Claims 2, 7, 10, 18 have been amended.
In summary, claims 1-27 are pending and examined in this office action.
All previous objections and rejections not set forth below have been withdrawn in view of the applicant’s amendment and/or upon further consideration. See “Response to Arguments” at the end of office action. The following rejections are repeated, modified and/or added for the reasons of record as set forth in the last Office action of 2/9/2025, and/or necessitated by the applicant’s amendments. The applicant’s arguments filed 6/5/2026 have been thoroughly considered but are not deemed fully persuasive.
Interpretation of claim 3
In the claim, “a plant of inbred broccoli line BP-1” is interpreted as a plant grown from the seed wherein a representative sample of seed of said inbred broccoli line was deposited under NCMA No. 202311014, in the same claim.
Claim Objections
Claim 2 is objected for the following informality:
It is suggested to change “produced by the seed of claim 1” to --- produced by growing the seed of claim 1 ---.
See claims 8 and 11, for example.
See the requirement of 37 CFR 1.71(a) for “full, clear, and exact terms”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
Lacking 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.
Claims 1-27 are rejected under 35 U.S.C. 112(a), 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 rejection is made because the specification fails to disclose the breeding history and parent lines of the instant inbred broccoli line BP-1.
In the instant application, a full examination cannot be conducted because the applicant failed to provide the parent lines and breeding history for the instantly claimed plant line. The applicant is claiming a seed and a plant of BP-1, possibly a new plant. A plant line is defined and described by both its genetics (breeding history particularly the parent line(s)) and its traits. In the instant application, the applicant has only provided a “Variety Description Information” of representative traits of BP-1 ([0039], Table 1). However, instant specification does not describe the breeding history, particularly the parent line(s), of the claimed BP-1. In another word, the instant application is silent or incomplete as to the breeding history used to produce the claimed plant line.
As a result, instant specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
MPEP 2163 (I) states that “…. a deposit is not a substitute for a written description of the claimed invention. 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.").” and states that “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 criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. 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 Line Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the line new” (See “Applying for a Plant Line Certificate of Protection” by the USDA reference to 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 line. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant line (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 line. 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 devoid of 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.
Furthermore, a breeding history particularly parent lines is essential to search siblings of instant plant to determine if there is/are any double patenting(s).
As seen above in Ex Parte C and Ex Parte McGowan, a trait table (for example, Table 2 in [0060]) is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species.
In the art, the physiological and morphological characteristics of plants depend on the genetical structure.
For example, Haun et al (The Composition and Origins of Genomic Variation among Individuals of the Soybean Reference Cultivar Williams. Plant Physiology. P645-655, 2011) teach that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false (P645, 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. (p645, right column; P646, left column).
For another example, Grobkinsky et al (Plant phenomics and the need for physiological phenotyping across scales to narrow the genotype-to-phenotype knowledge gap. Journal of Experimental Botany, Vol. 66, No. 18 pp. 5429–5440, 2015) teach that environmental variation may lead to phenotypic variation within a cultivar (p5430, last 2 paras; p5431, whole page). However, the genetic structure (genotype) is the major determinant of the phenotype of a plant (p5431, fig 2).
For another example, Tibbs-Cortes et al (Comprehensive identification of genomic and environmental determinants of phenotypic plasticity in maize. Genome Research. p1253-1263, 2024) teach that corn/maize phenotypes are determined by the complex interplay of genetics and environmental variables (p1253, Abstract). Tibbs-Cortes et al discovered that flowering time is controlled by some genes or candidate genes. Some genes are significantly influential to maize flowering time than the others (p1256, left col, last para; whole right col; Figure 3). Tibbs-Cortes et al teach that such genotypes are from the parents of the corns (p1259, right col, 3rd para; p1261, left col, 2nd para).
Particularly in broccoli plant, or example, Nandhini et al (Assessment of variability in Broccoli (Brassica oleracea var. italica L.) genotypes. The Pharma Innovation Journal 9(1): p338-340, 2020) tested 13 different genotypes of broccoli, and found that “the analysis of variance revealed significant differences among the 13 genotypes for all the traits studied” (p339, right col, 1st para, Table 1). Nandhini et al teach that the presence of genetic variation in the breeding material determines the success or failure of any breeding program. Therefore, the measurement of genetic variation and understanding the mode of inheritance of qualitative and quantitative traits are the essentials in any crop improvement program (p338, 1st para; p340, left col, 1st para).
Therefore, a breeding history especially parent lines are essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant, including in broccoli plants.
To overcome this rejection, the applicant must amend the specification/drawing to provide the breeding history used to develop the instant line or cultivar. When identifying the breeding history, the applicant should identify any and all other potential names for all parental lines utilized in the development of the instant line. For example, if the applicant’s breeding history uses proprietary line names, the 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, the 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, the applicant should provide the breeding history of the parent line as well (i.e. grandparents).
The applicant is also reminded that she or he has a duty to disclose information material to patentability. The 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 line). 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).
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 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.
Claims 15-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15-19 of co-pending Application No. 18767758/USPGPUB 20250017161.
The instant and co-pending applications share the same inventor, and the same applicant Sakata Seed Corp.
The co-pending application claims (as 7/9/2024).
15. A method for producing a seed of a broccoli plant derived from inbred broccoli line BP-2 comprising the steps of:
(a) crossing the broccoli plant of claim 3 with itself, a second broccoli plant and a third plant; and
(b) allowing seed of a broccoli plant derived from inbred broccoli line BP-2 to form.
16. The method of claim 15, further comprising the steps of:
(c) sowing a plant grown from said seed of said broccoli plant derived from inbred broccoli line BP-2 to yield seed derived from said inbred broccoli line BP-2;
(d) growing seed of step (c) to yield additional broccoli plants derived from inbred broccoli line BP-2.
17. The method of claim 15, wherein said second broccoli plant is an inbred broccoli plant of a different line, and wherein the method further comprises:
sowing said seed from said broccoli plant derived from inbred broccoli line BP-2; and
growing said broccoli seed yield a hybrid broccoli plant.
18. The method of claim 15, wherein said second broccoli plant is inbred broccoli line BP-1, wherein a representative sample of seed of said inbred broccoli line BP-1 was deposited under NCMA No. 202311014 broccoli line.
19. The method of claim 18, wherein said hybrid broccoli plant is hybrid broccoli line XBC8586.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 18-19, both applications claim a method of producing hybrid broccoli line XBC8586, by using the same parent lines BP-1/NCMA 202311014 and BP-2/NCMA 202311015.
Regarding claims 15-17 that are more generic and broader than claims 18-19, the BP-2 of co-pending application is a specific species of the “second broccoli plant” of instant claims 15-18; the BP-1 of instant application is a specific species of the “second broccoli plant” of co-pending claims 15-18.
In addition, the co-pending and instant applications have essentially the same claim language.
Therefore, the claims are obvious over each other in co-pending and instant applications.
Remarks
Both instant application and co-pending application 18767758 were filed the same day, 7/9/2024. However, the IDS filed on 10/4/2024 by the applicant did not disclose the co-pending application. Upon further consideration, the co-pending application 18767758 and instant application are searched and examined side by side.
By name search, instant broccoli BP-1, along with broccoli BP-2, was published in the applicant’s website https://sakatavegetables.com/patents/. However, it appears that the document was published 9/2/2022 by the applicant, thus, is a 102 (a)(1) exception.
Otherwise, instant BP-1 has no prior art in patent, patent application or NPL. Prior art does not disclose any corn has all of the physiological and morphological characteristics of instant BP-1.
The “BREEDING HISTORY FOR INBRED BROCCOLI LINE BP-1” was provides by the applicant as “Non Patent Literature” on 6/5/2026. However, the specification has not been amended to include such information. As analyzed above, the breeding history and parent lines are required to be in the specification.
For compact prosecution, the examiner searched the following:
In the “Non Patent Literature” on 6/5/2026, the applicant discloses:
“BREEDING HISTORY FOR INBRED BROCCOLI LINE BP-1
The original parental lines used to produce Inbred Broccoli line BP-I are:
Female: unnamed female line
Male: Selection from broccoli line Violet Queen (unpatented)
In 1994 a selection was made from the broccoli line Violet Queen and the selection was self-pollinated. In 1995 the selection was self-pollinated and in 1996 the selection was again self-pollinated. In 2002 the selection was crossed with an unnamed proprietary female broccoli line and from 2003 to 2017 the self-pollination from 2002 was continuously selected and self-pollinated. In 2018, the selected line was designated BP-1.
There are no siblings from the breeding history of BP-1.”
Thus, the breeding history is partial. Only one of the 2 initial parents Violet Queen is disclosed, the other parent is not disclosed. The “unnamed female line” is changeable, thus, can be any line, and cannot be considered a sufficient disclosure. If the line is unpublished, an internal or experimental name should be disclosed.
“Violet Queen”, the male parent, was disclosed, not claimed, by Mero of Seminis Vegetable Seeds (US 8759621, granted and published 6/24/2014) in Col 11-12, Table 2.
Note: the breeding history and parental lines of instant BP-1 are missing in the instant specification. When such breeding history and parental lines become available (See the 112a rejection above), the examiner will perform further search. Art and/or more double patenting rejections may be made.
Response to Arguments
Claim Objections, Rejections for Indefiniteness
The objections and rejections are withdrawn in view of the claim amendments.
Claim Rejections - 35 USC 112(a) - Lack of written description
Applicant respectfully traverses this rejection. Applicant respectfully agrees and submits that breeding history for broccoli line BP-1 is relevant to patentability and as such Applicant herein submits with this response an information disclosure statement where the breeding history has been submitted as non-patent literature. However, Applicant submits that the breeding history is not relevant to nor is it required to meet the written description and enablement requirements of US patent law.
Applicant submits that as submitted by the US Department of Justice to the Delaware Federal District Court on May 18, 2026 as a Party of Interest in Corteva Agriscience v. Inari Agriculture (Lawsuit filed on September 27, 2023 in Federal District Court of Delaware, case number No. 23- 1045), in order "to secure a patent, an applicant is required to adequately disclose the protected material so that the public can access and understand what is protected and the state of the art is expanded to allow follow-on innovation. This disclosure "requirement is to ensure that the scope of the right to exclude.. . does not overreach the scope of the inventor's contribution,"" citing Ariad Pharm., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010).
The courts have held that the "disclosure both permits the public to understand the innovation protected under IP law, thus clearly identifying the invention to avoid infringement," Amgen, 598 U.S. at 605 (quoting United States v. Dubilier Condenser Corp., 289 U.S. 178, 187 (1933)); see also Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1298 (Fed. Cir. 2014) The US Supreme Court has explained, "Congress has exercised this authority ... from the start," setting out the "quid-pro-quo premise of patent law" in the Patent Act of 1790, requiring every applicant to disclose sufficiently detailed information so "as not only to distinguish the invention or discovery from other things before known and used, but also to 'enable a workman or other person skilled in the art or manufacture . .. to make, construct, or use the same."' Id. at 605 (quoting Act of Apr. 10, 1790 § 2, 1 Stat. 110). The enablement and written description requirements remain in effect today. Id. (quoting 35 U.S.C. §§ 111, 112); see also Universal Oil Prods. Co. v. Globe Oil & Refining Co., 322 U.S. 471, 484 (1944)
This disclosure requirement is crucial because it "allows the [USPTO] to examine the invention, determine compliance with the statute, and to construe the claims; and the public to understand and improve upon the invention and to avoid the claimed boundaries of the patentee's exclusive rights." Id.; see also Schriber-Schroth Co. v. Cleveland Trust Co., 305 U.S. 47, 56-57 (1938) (disclosure "inform[s] the public during the life of the patent of the limits of the monopoly asserted, so that it may be known which features may be safely used or manufactured without a license and which may not"). Only if these disclosures are adequately made will a patent issue because "exclusive patent rights are given in exchange for disclosing the invention to the public." Festo, 535 U.S. at 736. For biological material, "[o]ne means that has been developed for complying with the enablement [and written description] requirement] is to deposit the living materials in cell depositories which will distribute samples to the public who wish to practice the invention after the patent issues." In re Wands, 858 F.2d at 735 (citing In re Argoudelis, 434 F.2d 1390, 1392-93 (C.C.P.A. 1970)
As discussed by the Department of Justice submission to the court in Corteva v. Inari , "[i]t is... common practice for patent applicants to meet the written description and enablement requirements of 35 U.S.C. Q 112 by supplementing (or even replacing) their written disclosures with deposits of biological material in a recognized depository. See, e.g., Ajinomoto Co. v. Archer- Daniels-Midland Co., 228 F.3d 1338, 1345-46 (Fed. Cir. 2000) (explaining that a deposit helps to satisfy the enablement requirement).
Applicant respectfully submits that the independent claims of the current application are to seed and plants of broccoli line BP-1 and as provided above, a deposit of seed of BP-1 would satisfy the written description and enablement requirement to allow third parties to reproduce the claimed invention, that is the deposit allows one skilled in art to reproduce broccoli line BP-1. To that end, Applicant has submitted a biological deposit of broccoli line BP-1 under the Budapest Treaty to the NCMA depository and NCMA has confirmed the viability of the deposit.
Further, Applicant agrees that the breeding history of broccoli line BP-1 is relevant to the patentability of broccoli line BP-1, however Applicant respectfully submits that providing the breeding history in the specification is not relevant to the written description or enablement requirements of 35 U.S.C. § 112.
Applicant respectfully submits that providing the breeding history of broccoli line BP-1 in the specification of the current application would not teach or enable one skilled in the art to reproduce the claimed invention. To the contrary, publicly disclosing the parental lines and the breeding history of broccoli line BP-1 in the specification would teach a person skilled in the art the exact same steps used to produce BP-1, however one skilled in the art, while following the same breeding history, would not be able to reproduce a plant capable of producing the same seed of the biological deposit as provided the claimed invention. Providing the parental lines and the breeding history does not enable someone to produce the same invention nor does it prevent infringement, to the contrary, by providing the parental lines and the breeding history in the specification, as required by the Examiner, would simply allow a person skilled in the art to produce a broccoli line that is very similar to line BP-1 however the new broccoli line would not be the same as the line in the biological deposit and thus the new line would not infringe the claims of the current application. The requirement to add the parental lines and the breeding history to the specification is actually teaching one skilled in the art how to make a broccoli line similar to but one that does not infringe line BP-1.
This applicant has submitted the requested breeding history information in an information disclosure statement and respectfully requests withdrawal of this rejection.
The arguments are fully considered but not deemed persuasive.
The applicant seems to argue that a deposit is sufficient to satisfy written description requirement (thus, disagree with the office), but also seems to agree with the office that a breeding history is necessary to satisfy written description requirement.
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).”
Accordingly, the examiner will evaluate what is an adequate written description for new tomato lines. In reviewing this question of fact, the examiner analyzed how plant lines 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). The breeding history of BP-1, is missing 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.
Furthermore, a breeding history particularly parent lines is essential to search siblings of instant plant to determine if there is/are any double patenting(s).
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, the applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, the applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If the applicant’s breeding history uses proprietary cultivar names, the applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, the 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, the applicant should provide the breeding history of the parent line as well (i.e., grandparents). The 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.
In summary, the breeding history and parent lines should be disclosed in the specification. Disclosing the breeding history and parent lines in an IDS or elsewhere does not overcome the rejection.
In another word, the disclosure in the IDS would not satisfy the written description, because the breeding history is not in the specification, such that “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”. In this case, one skill in the art does not even see the breeding history in the specification.
In addition, as analyzed above, the disclosed breeding history in the “Non Patent Literature” is partial, not full. Only one of the 2 initial parents Violet Queen is disclosed, the other parent is not disclosed. The “unnamed female line” is changeable, thus, can be any line, and cannot be considered a sufficient disclosure. If the line is unpublished, an internal or experimental name should be disclosed.
Double Patenting
Applicant respectfully requests this rejection be held in abeyance until the outstanding 112 rejections have been overcome.
Applicants’ request to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an objection or requirements as to form (see MPEP 37 CFR 1.111(b) and 714.02). Accordingly, the rejection will be maintained until a terminal disclaimer is filed or claims are amended to obviate the rejection.
Conclusion
THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). The 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 extension fee 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 date of this final action.
Contact information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WAYNE ZHONG whose telephone number is (571)270-0311. The examiner can normally be reached 8:30am to 5:00pm EST.
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, Bratislav Stankovic, can be reached on 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Wayne Zhong/
Primary Examiner, Art Unit 1662
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