DETAILED ACTION
Claims 1-7 and 9-23 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The warning that should claim 5 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof is withdrawn in light of Applicant’s cancellation of the claim.
The rejection of claims 1-23 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s deposit statement.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 1-7 and 9-23 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 claim(s) contains subject matter that 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.
Due to Applicant' s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 10 June 2025, as applied to claims 1-23. Applicant’s arguments filed 9 December 2025 have been fully considered but they are not persuasive.
A. Claim 13 is drawn to an onion plant produced by a method comprising backcrossing a desired trait into a plant of onion line SVNB6749, wherein a single locus conversion confers said trait and said plant comprises said single locus conversion and otherwise comprises all of the physiological and morphological characteristics of onion line SVNB6749.
Claim 13, while requiring via its parent claim that the plant have the desired trait and otherwise all the physiological and morphological characteristics of SVNB6749, places no limits on the number of desired traits in the claimed plant. The claim thus reads on an onion plant with any number of differences in physiological and morphological characteristics and genetics compared to SVNB6749.
The specification describes no structural features that distinguish plants of onion line SVNB6749 comprising any number of desired traits or differences in physiological and morphological characteristics and/or genetics from other onion plants.
Hence, Applicant has not, in fact, described the onion plants of claim 13, and the specification fails to provide an adequate written description of the claimed invention.
Therefore, given the lack of written description in the specification with regard to the structural and functional characteristics of the claimed compositions, Applicant does not appear to have been in possession of the claimed genus at the time this application was filed.
B. The 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 to conduct an examination, including search of the prior art
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.").
The instant specification fails to satisfy the written description because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement.
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).
In the instant application, a full examination cannot be conducted. In claims 1-23, Applicant claims a new onion plant line. A plant line, variety or cultivar is defined by both its genetics (breeding history) and its traits. In the instant application, the specification only provides a description of the plant traits (Table 1). The instant specification is silent as to the breeding history used to produce the claimed plant line.
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 Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (USDA, “Applying for a Plant Variety Certificate of Protection”, https://www.ams.usda.gov/services/pvpo/application-help/apply, accessed 1 May 2023). 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 (UPOV, 2017, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, see 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, 2020). 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 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.
As seen above in Ex Parte C and Ex Parte McGowan, trait tables are insufficient to differentiate plant lines by themselves. A breeding history is an essential and the least burdensome way to provide genetic information needed to adequately 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 to provide the breeding history used to develop the instant onion line. 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 onion line. 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 any 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(s) 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).
Response to Arguments
Applicant urges that the claim amendments have overcome part A of the rejection (response pg 7).
This is not found persuasive. While the rejection over claim 15 has been overcome, that over claim 13 has not. Claim 13 still reads on a plant with any number of desired traits; that they are conferred by single locus conversions does not limit the number of desired traits in the plant. If Applicant wishes to claim a plant with a single locus conversion and otherwise all of the physiological and morphological characteristics of onion line SVNB6749, the claim should be written that way.
Applicant urges that the written description requirement is provided by the deposit, such that they do not have to provide a breeding history, citing Ex Parte C, Enzo, Inari, in re Lundak, and a letter from the USPTO director (response pg 7-14).
This is not found persuasive.
Regarding Applicants’ arguments on the legal basis of the written description rejection and the court’s/board’s interpretations, the best starting point for a written description analysis is the law itself. The first 10 words of 35 USC 112(a) are critical.
(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. (emphasis added)
The strict interpretation of the law is clear: Applicant must provide in the specification a written description of the invention. The only question is what an “adequate written description” is. This is a fact-based inquiry done by the factfinder (i.e., the examiner) when analyzing the nature of the instant invention.
The references cited in the rejection are evidence regarding that question of fact regarding what is considered when describing plants. They are not cited for legal analysis. The references cited, including USDA and UPOV, establish that in the plant variety art, a breeding history is part of the description of a plant variety.
Applicant has not provided evidence saying that in the plant variety art the breeding history is not considered part of the description of a plant variety. Applicant has not rebutted the evidence provided in the rejection.
The Office has made a finding of fact that for the instant variety the minimum description is the combination of the phenotype and genotype (breeding history). To support this finding of fact, the Office has cited other plant-related intellectual property organizations and relevant court cases dealing with plant varieties in which both the phenotype and genotype are analyzed. The Office did not cite these findings to clarify the law. They are solely to clarify the finding of fact, i.e., what is an adequate written description for the instant plant variety. Applicant’s arguments ask the Office to not consider the actual statute and base our decision solely on statements from court/board cases that do not directly decide what an adequate written description is for a plant variety.
Lastly, 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).
If Applicant has issues with the guidance in the MPEP, arguing with the examiner applying that guidance is not the solution, as examiners have no role the decision to include that guidance in the MPEP.
Applicant urges that a 1.105 request is the proper mechanism to provide information useful to examination (response pg 15).
This is not found persuasive.
MPEP 704.11(a) provides a list of Examples of Information Reasonably Required by a Request for Information under 37 CFR 1.105(a), as does 37 CFR 1.105(a)(1)(i)-(viii) itself. A description of what is being claimed in not in those lists.
The proper place for a description of what is being claimed is in the specification, as set forth in 35 USC 112(a).
Phenotype and/or parental information provided only as a trade secret does not inform the public. Once that information is expunged in response to a petition to expunge, the public has no way to access that information and that description of the claimed invention.
Applicant provided the name for the parent of the instant plant in the IDS transmittal letter filed 14 December 2023. IDS transmittal letters are also not part of the specification.
While Applicant urges that the deposit provides all the description necessary to meet the requirements of written description, that is not the case. The deposit is necessary but not sufficient.
If a deposit were all that is needed, then a phenotype table that includes traits affected by the environment would not be necessary. However, a plant described only by a deposit cannot be examined; the patent office does not have the facilities to grow up the claimed plant and all onion plants in the art to compare their phenotypes and do a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant to see if the claimed plant is genetically related to the prior art plant.
There are over 25 patents on onion varieties and about that number of patent applications that have been published but not yet issued. The number of patents on onion varieties will continue to grow. If these onion plants were only described by deposit, one needing to know the phenotype and genotype of any or all of the plants, as would a onion breeder, would need to grow each up to evaluate phenotype and perform a genetic analysis to evaluate genotype. Performing a phenotypic and genetic analysis on all these onion plants would be an undue burden on each onion breeder. It would also be a burden on the patent holder, as the deposited seed would rapidly be depleted and would need frequent replacement. Lastly, as deposits do not need to be maintained into perpetuity, the genetic information provided therein would no longer be available if there is a 5-year gap after the last request, shutting later breeders out of the information therein. Words describing the phenotype and parents of an onion plant do not shut future inventors out of a description of a prior art onion plant.
Similarly, merely providing in the specification arbitrary names for the parents of an onion plant and hiding the publically known names for them is not useful to someone that is not the Applicant, and does not describe an invention to the examiner or the public.
Phenotypic and parental (genetic) information and a deposit are all necessary parts of the description of an onion plant.
Claim Rejections - 35 USC §§ 102, 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claims 1-7 and 9-23 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Burkett (2017, U.S. Patent No. 9,648,816) taken with the evidence of US PVP Grant No. 201300459, Onion Variety SV4522NB (2017).
The rejection is repeated for the reasons of record as set forth in the Office action mailed 10 June 2025, as applied to claims 1-23. Applicant’s arguments and the Asoro Declaration, both filed 9 December 2025 have been fully considered but they are not persuasive.
‘816 teaches plants and seeds of SV4522NB (claims 1-2; Table 1).
The transmittal letter for the IDS filed 14 December 2023 in the instant application indicates that instant SVNB6749 was made by several rounds of selfing SV4522NB. The transmittal letter also states that SV4522NB is heterozygous.
However, ‘816 indicates that SV4522NB is an inbred, i.e., not heterozygous. For example, column 5, lines 41-44, states
SV4522NB is uniform and stable. A small percentage of variants can occur within commercially acceptable limits for almost any characteristic during the course of repeated multiplication. However no variants are expected.
The PVP Grant for SV4522NB also says this (pg 4, section 8):
No genetic variants or off-types have been observed during 3 generations of reproduction and seed increases in 2009, 2010, and 2011, which indicates that SV4522NB is genetically uniform. No variants are known or expected to occur.
Only inbreds, when repeatedly multiplied, show no variants. If SV4522NB were heterozygous, then variants would be seen in the progeny produced by its repeated multiplication and reproduction and seed increases.
Column 7, lines 41-44, of ‘816 states
One aspect of the current invention concerns methods for crossing the onion line SV4522NB with itself or a second plant and the seeds and plants produced by such methods. These methods can be used for propagation of line SV4522NB, or can be used to produce hybrid onion seeds and the plants grown therefrom. Hybrid seeds are produced by crossing line SV4522NB with second onion parent line.
Only if SV4522NB is an inbred can crossed with itself to propagate SV4522NB. If SV4522NB were heterozygous, then the progeny produced by crossing SV4522NB with itself will be hybrids that segregate for various genes and traits; these hybrids would not be SV4522NB.
Lastly, ‘816’s claim 18 reads as follows:
18. A method of introducing a desired trait into onion line SV4522NB comprising: (a) crossing a plant of line SV4522NB with a second onion plant that comprises a desired trait to produce F1 progeny, a sample of seed of said line SV4522NB having been deposited under ATCC Accession Number PTA-121600; (b) selecting an F1 progeny that comprises the desired trait; (c) crossing the selected F1 progeny with a plant of line SV4522NB to produce backcross progeny; (d) selecting backcross progeny comprising the desired trait; and (e) repeating steps (c) and (d) three or more times to produce selected fourth or higher backcross progeny that comprise the desired trait and otherwise all of the physiological and morphological characteristics of onion line SV4522NB when grown in the same environmental conditions.
Only if SV4522NB is an inbred can a desired trait be backcrossed into it, using it as a recurrent parent to produce a plant with the desired trait and otherwise all of the physiological and morphological characteristics of onion line SV4522NB. If SV4522NB were heterozygous, then the progeny produced by producing backcross progeny as claimed in ‘816’s claim 18 would segregate for various genes and traits; plants with the desired trait and otherwise all of the physiological and morphological characteristics of onion line SV4522NB could never be made.
Since ‘816 indicates that SV4522NB is an inbred, selfing SV4522NB, followed by several rounds of selfing would produce SV4522NB. Thus, instantly claimed SVNB6749, which was made by selfing SV4522NB, followed by several rounds of selfing, must be SV4522NB or a plant with all of the physiological and morphological characteristics of onion line SV4522NB.
Although Table 1 of ‘816, which describes SV4522NB, shows some differences in its physiological and morphological characteristics when compared to the physiological and morphological characteristics of the instantly claimed plant (instant Table 1), these differences must be the result of environmental influence. ‘816 and the instant specification acknowledge that at least some of SV4522NB’s and SVNB6749’s traits are affected by the environment the plant was grown in (column 5, lines 15-22 and the footnote of Table 1 of ‘816; ¶30 and the footnote of Table 1 of the instant specification). As the data in Table 1 of ‘816 and that of the instant Table 1 were produced from plants grown in different years, the plants were grown in different environments. As the evidence detailed above shows that SVNB6749 is SV4522NB, any differences in the physiological and morphological characteristics between Table 1 of ‘816 and the instant Table 1 must be due to environmental influence.
If the statements and claims in ‘816 are incorrect and SV4522NB is heterozygous, one of ordinary skill in the art would have seen that when seed is produced from SV4522NB, variants appear in the progeny. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to perform several rounds of selfing SV4522NB. One of ordinary skill in the art would have been motivated to do so because they would have wanted an onion variety that was true-breeding (i.e., homozygous) so that seed sold to onion growers would be true to type; the onion growers would then know what the traits the onion plants grown from the seed would have. Further, producing an onion variety that was true-breeding would allow one of ordinary skill in the art to backcross a desired trait into plants of the new onion variety. Plants of SVNB6749 would be among the onions so produced.
Instant claims 1-2, 4-8, 12-13 and 20 are identical to claims 2, 1, 4-8, 18-19 and 24, respectively, of ‘816, except for the name of the variety.
The plant parts claimed in claim 4 of ‘816 all comprise a cell of the plant.
The methods claimed in claims 14-15 of ‘816 are species of instant claims 9-10, and the methods claimed in claims 16-17 of ‘816 together are species of instant claim 11.
It would be obvious to one of ordinary skill in the art to perform the method of introducing a transgene into SV4522NB claimed in claim 21 of ‘816 by genetic transformation as this is one of the routine ways to introduce a transgene into plant. Further, it would be obvious to one of ordinary skill in the art for the transgene to confer a trait like herbicide, insect, pest, or disease resistance, as this would allow growth of the plant in areas where disease or pests are prevalent and would allow growing practices that kill weeds with herbicides. Thus, claims 21-22 of ‘816 render the method of instant claim 14 and the resulting plants claimed in instant claim 15-17 obvious.
The method of introducing a desired trait into SV4522NB by backcrossing as claimed in claim 18 of ‘816 would be a method of introducing a single locus conversion into the instantly claimed plant, as a trait can be conferred by a single locus or gene. Further, it would be obvious to one of ordinary skill in the art for the single locus conversion to confer a trait like herbicide, insect, pest, or disease resistance, as this would allow growth of the plant in areas where disease or pests are prevalent and would allow growing practices that kill weeds with herbicides. Thus, claims 18-19 of ‘816 render the plants so produced, as claimed in instant claims 18-19, obvious.
It would have been obvious to one of ordinary skill in the art to use marker-assisted selection in these backcrossing methods to speed up the process as selection using markers can more rapidly identify each generation’s progeny homozygous for the genes in the recurrent parent. This method would involve detecting by sequencing or genetic marker analysis polymorphisms in nucleic acids from the parent plant and the progeny and recording the resulting data in notebooks or a computer readable medium. Thus, instant claims 21-24 are obvious.
Response to Arguments
Applicant urges and the Declaration states that SV4522NB and SVNB6749 differ significantly in ease of stripping and plant vigor and that SVNB6749 was selected for heat tolerance (response pg 15-16; Declaration ¶5).
This is not found persuasive. First, there is no statement that the plants were grown side-by-side. The statement that the trials were controlled for confounding factors including environment (Declaration ¶5) suggests that they were not.
Second, if SV4522NB is heterozygous, one of ordinary skill in the art would have seen that when seed is produced from SV4522NB, variants appear in the progeny. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to perform several rounds of selfing SV4522NB so as to get an onion variety that was true-breeding (i.e., homozygous) and that seed sold to onion growers would be true to type. Plants of SVNB6749 would be among the onions so produced.
It would have been obvious to one of ordinary skill in the art in that process to select for plants with desirable traits that appear in the progeny. Lower stripping and vigor scores and greater heat tolerance would have been amongst those, based on Declarant’s statement of the general desirability of these traits.
Applicant urges and the Declaration states that one of ordinary skill in the art could not have predicted the claimed plant as selfing a selection of plants produced from an initial A cepa X A. fistulosum cross can unexpectedly yield plants that differ from its parents in unexpected ways (response pg 16; Declaration ¶6).
This is not found persuasive. SVNB6749 would be among the onions produced by selfing heterozygous SV4522NB plants, if it not alere4ady part of the genus that is SV4522NB.
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); 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 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 1-2, 4-7, 12-13 and 20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-2, 4-8, 18-19 and 24 of prior U.S. Patent No. 9,648,816 or, in the alternative, claims 1-23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 9,648,816.
The rejection is repeated for the reasons of record as set forth in the Office action mailed 10 June 2025, as applied to claims 1-2, 4-8, 12-13 and 20. Applicant’s arguments and the Asoro Declaration, both filed 9 December 2025 have been fully considered but they are not persuasive.
The evidence detailed above in the rejection under35 USC §§ 102, 103 showing that SVNB6749 is SV4522NB is incorporated herein.
Instant claims 1-2, 4-8, 12-13 and 20 are identical to claims 2, 1, 4-8, 18-19 and 24, respectively, of ‘816, except for the name of the variety. These claim the same invention as ‘816.
The plant parts claimed in claim 4 of ‘816 all comprise a cell of the plant, thus rendering instant claim 3 obvious.
The methods claimed in claims 14-15 of ‘816 are species of instant claims 9-10, and the methods claimed in claims 16-17 of ‘816 together are species of instant claim 11, thus rendering instant claims 9-11 obvious.
It would be obvious to one of ordinary skill in the art to perform the method of introducing a transgene into SV4522NB claimed in claim 21 of ‘816 by genetic transformation as this is one of the routine ways to introduce a transgene into plant. Further, it would be obvious to one of ordinary skill in the art for the transgene to confer a trait like herbicide, insect, pest, or disease resistance, as this would allow growth of the plant in areas where disease or pests are prevalent and would allow growing practices that kill weeds with herbicides. Thus, claims 21-22 of ‘816 render the method of instant claim 14 and the resulting plants claimed in instant claim 15-17 obvious.
The method of introducing a desired trait into SV4522NB by backcrossing as claimed in claim 18 of ‘816 would be a method of introducing a single locus conversion into the instantly claimed plant, as a trait can be conferred by a single locus or gene. Further, it would be obvious to one of ordinary skill in the art for the single locus conversion to confer a trait like herbicide, insect, pest, or disease resistance, as this would allow growth of the plant in areas where disease or pests are prevalent and would allow growing practices that kill weeds with herbicides. Thus, claims 18-19 of ‘816 render the plants so produced, as claimed in instant claims 18-19, obvious.
It would have been obvious to one of ordinary skill in the art to use marker-assisted selection in these backcrossing methods to speed up the process as selection using markers can more rapidly identify each generation’s progeny homozygous for the genes in the recurrent parent. This method would involve detecting by sequencing or genetic marker analysis polymorphisms in nucleic acids from the parent plant and the progeny and recording the resulting data in notebooks or a computer readable medium. Thus, instant claims 21-24 are obvious.
If the statements and claims in ‘816 are incorrect and SV4522NB is heterozygous, one of ordinary skill in the art would have seen that when seed is produced from SV4522NB, variants appear in the progeny. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to perform several rounds of selfing SV4522NB. One of ordinary skill in the art would have been motivated to do so because they would have wanted an onion variety that was true-breeding (i.e., homozygous) so that seed sold to onion growers would be true to type; the onion growers would then know what the traits the onion plants grown from the seed would have. Further, producing an onion variety that was true-breeding would allow one of ordinary skill in the art to backcross a desired trait into plants of the new onion variety. Plants of SVNB6749 would be among the onions so produced.
Response to Arguments
Applicant incorporates the arguments made in response to the 102/103 rejection above (response pg 16-17).
This is not found persuasive. The response to those arguments are incorporated herein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
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/Anne Kubelik/Primary Examiner, Art Unit 1662
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