DETAILED ACTION
Claims 1-20 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 rejection of claims 1-20 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s deposit statement.
The specification is objected to for the following reasons:
a. The amendment to the specification cannot be entered because the amendment does not follow the Amendment Practice of 37 CFR 1.121(b)(1)(i):
(b) Specification. Amendments to the specification, other than the claims, "Large Tables" (§ 1.58(c) ), a "Computer Program Listing Appendix" (§ 1.96(c)(5) and (7) ), a "Sequence Listing" (§ 1.825 ), or a "Sequence Listing XML" (§ 1.835 ), must be made by adding, deleting, or replacing a paragraph; by replacing a section; or by providing a substitute specification, in the manner specified in this section.
(1) Amendment to delete, replace, or add a paragraph. Amendments to the specification, including amendment to a section heading or the title of the invention which are considered for amendment purposes to be an amendment of a paragraph, must be made by submitting:
(i) An instruction, which unambiguously identifies the location, to delete one or more paragraphs of the specification, replace a paragraph with one or more replacement paragraphs, or add one or more paragraphs;
Applicant did not provide an instruction that unambiguously identifies the location replace a paragraph with the replacement paragraph.
b. The specification remains objected to for the presence of blank lines on pg 46, line 22.
In the response filed 9 January 2026 Applicant urges that pg 48 is amended (response pg 48).
This is not found persuasive for the reasons above. It is noted that the deposit statement is on pg 46-47, not pg 48.
Claim Objections
Claims 12-15 and 18-20 are objected to because of the following informalities:
The objection is repeated for the reasons of record as set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
In claim 14, line 1, --, the method-- should be inserted after “breeding”.
In claim 18, a comma should be inserted after “techniques” in line 2 and a comma should be inserted after “transformation” in line 5.
Response to Arguments
Applicant urges that the claims were amended (response pg 7).
This is not found persuasive because the above were missed.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of the second paragraph of 35 U.S.C. 112:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention. Dependent claims are included in all rejections.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
Claims 1-2, 8, 15, 17, and 20 are indefinite in their recitation of “maize line BDAX4615”.
The specification describes “BDAX4615” as variety in Table 1.
The specification defines “variety” as follows (pg 18, lines 3-5):
CULTIVAR and VARIETY refer to a group of similar plants that by structural or genetic features and/or performance can be distinguished from other varieties within the same species.
This definition both indicates that a plant with even a single base difference from BDAX4615 is a different variety and that a plant with the same “performance” as BDAX4615, but different genetics, is a plant of “maize variety BDAX4615”. “Performance” is not defined by the specification, so it is not clear what is encompassed by “performance”. It is also not clear if “performance” in the definition above means only plants that are the same in all possible aspects of “performance” fall within “maize variety BDAX4615”, or if plants that are the same in only one aspect of “performance” do.
The definition of “locus conversion” provides yet another definition of “variety” (pg 28, lines 15-20):
A locus conversion refers to plants within a variety that have been modified in a manner that retains the overall genetics of the variety and further comprises one or more loci with a specific desired trait, such as male sterility, insect resistance, disease resistance or herbicide tolerance or resistance. Examples of single locus conversions include mutant genes, transgenes and native traits finely mapped to a single locus. One or more locus conversion traits may be introduced into a single corn variety. (emphasis added)
This definition indicates that maize variety BDAX4615 plants include those into which one or more mutant genes, transgenes or native traits have been introduced. The specification does not define “retain the overall genetics of the line”. It is not clear what level of variation is encompassed within “retains the overall genetics of the variety” and what the overall genetics of BDAX4615 are. It is thus not clear when the boundary to not retaining the overall genetics of the maize line is crossed.
The specification on pg 24, lines 15-22, provides the following definition of “variety”:
A specific location on a chromosome can be referred to as a locus. Trait conversion refers to a variety that has been modified such that the variety retains its physiological and morphological characteristics except for those changed by the introduction of the trait. Thus a variety undergoing a herbicide resistance trait conversion will evidence the additional trait of resisting damage by the herbicide. The variety will after trait conversion have one or more loci with a specific desired trait. Such a variety modification may be through mutant genes, transgenes, or native traits. A maize line and any minor genetic modifications which may include a trait conversion, a mutation, or a variant is a variety. (emphasis added)
The specification defines “a” as follow (pg 15, lines 20-21):
A, AN, THE - As used herein, "a," "an" or "the" can mean one or more than one. For example, a cell can mean a single cell or a multiplicity of cells.
Thus, the definition of “variety” on pg 25, lines 5-13, indicates that any number of trait conversions, mutations, or variants all fall within a variety, and that trait conversions can involve multiple loci.
These definitions all clash with one another. The definition of CULTIVAR and VARIETY on pg 18, lines 3-5, suggests that a plant with even a single base difference from BDAX4615 is a different variety, but the definitions of “locus conversion” on pg 28, lines 15-20, and the definition of “variety ”on pg 24, lines 15-22, indicate that plants with locus conversions, which confer genetic differences, are also part of the variety. It is not clear which definition controls.
These definitions render the metes and bounds of the variety name unclear, and it is unclear what plants fall within “maize variety BDAX4615” and thus, “maize line BDAX4615”. It is not clear what genetics a plant of “maize variety BDAX4615” must have, if any, and it is not clear how many trait conversions, mutations, or variants it takes for the plant to no longer be a plant of “maize variety BDAX4615” or “maize line BDAX4615”.
Further, these definitions make it unclear in what way the seeds to be deposited are “representative” of the variety. If a locus converted plant is “within a variety”, is this deposit representative of the full scope of plants both with and without locus conversions? If a variety encompasses plants with trait conversions, mutations, or variants, is this deposit representative of the full scope of plants with the full scope of trait conversions, mutations, or variants? If a variety encompasses plants with the same “performance”, but different genetics, is this deposit representative of the full scope of plants with the same “performance” as BDAX4615?
This portion of this rejection can be overcome by amending both recitations of “variety” in Table 1 to --line--.
Claim 6 is indefinite in its recitation of “A maize plant having all of the physiological and morphological characteristics of the plant according to claim 2 and further comprising a desired trait”. A plant cannot have both a desired trait and have all of the physiological and morphological characteristics of BDAX4615. The former is excluded by the latter, and former means that the plant does not have all of the physiological and morphological characteristics of BDAX4615. Thus, the metes and bounds of the claim are unclear.
Claim 8 is indefinite in its recitation of “A converted seed, plant, plant part or plant cell of maize line BDAX4615, representative seed of the maize line BDAX4615 having been deposited under ATCC accession number PTA _____, wherein the converted seed, plant, plant part or plant cell comprises a locus conversion …”. The metes and bounds of what a “A converted seed, plant, plant part or plant cell of maize variety BDAX4615” would be is completely unclear, especially since the loci are converted relative to the undefined genus “maize variety BDAX4615” that already encompasses any number of trait conversions, mutations, variants, transgenes or added native traits.
Claim 12 lacks antecedent basis for the limitation “the plant germinated from said seed”. The seed of claim 10 is a genus of F1 progeny of the plant of claim 2, encompassing seeds in which the second parent is any other maize plant. Plants grown from the seed encompass those of a wide range of genotypes. Because there is not just one type of seed encompassed by claim 10, there is not just one possible plant that can be grown from the seed of claim 10.
Claim 14 lacks antecedent basis for the limitation “the plant” in line 3. There are two different plants recited previously in the claim, one in line 1 and one earlier in line 3.
Claim 15 is indefinite in its recitation of “to produce backcross progeny plants that comprise the additional trait and all of the physiological and morphological characteristics of maize inbred plant BDAX4615”. A plant cannot have both an additional trait and have all of the physiological and morphological characteristics of maize inbred plant BDAX4615. The former is excluded by the latter, and former means that the plant does not have all of the physiological and morphological characteristics of maize inbred plant BDAX4615. Thus, the metes and bounds of the claim are unclear.
Claim 19 lacks antecedent basis for the limitation “said commodity plant product comprising protein concentrate, protein isolate, starch, meal, flour or oil”. The commodity plant product recited in line 1 is not limited to comprising protein concentrate, protein isolate, starch, meal, flour or oil.
Claim 20 lacks antecedent basis for the limitation “the maize variety BDAX461”.
Response to Arguments
Applicant urges that the claims do not recite “variety” and claims 4, 6, 8 are also amended (response pg 7-8).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. This portion of this rejection can be overcome by amending both recitations of “variety” in Table 1 to --line--.
The amendments to claim 6 and 8 did not address all the rejections and no amendments were made to overcome the rejections of claims 12, 14-15 and 19-20.
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 1-20 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 claims contain 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 pre-AIA 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 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
A. The instant claims are broadly drawn to plants and seeds of maize line BDAX4615, and plants and seed derived from said variety, and methods of using said line.
As discussed, above, in the indefiniteness rejection and incorporated herein, the specification describes BDAX4615 as a “variety” and provides such broad definitions of “variety” that the metes and bounds of what maize plants would be covered by “maize line BDAX4615” are completely unclear. The definitions in the specification indicate that “maize variety BDAX4615” includes any number of trait conversions, mutations, variants, transgenes or added native traits relative to a starting plant, and this encompasses an unlimited number of changes to the genome and to the phenotypes and characteristics of the plants.
The instant specification does not describe any embodiment of a plant produced by adding any number of trait conversions, mutations, variants, transgenes or added native traits to a plant of BDAX4615. Given that the underlying genetics can be dramatically changed with thousands of base changes, rearrangement, or substitutions in the genomic DNA, and that the phenotypic, physiological and morphological characteristics can be changed due to multiple changes in traits as a result of the mutations, variations, conversions, or transgenes, the genus of mutant plants encompassed by claims is not adequately described.
Further, claims 6-8 and 16 are drawn to maize variety seeds, plants, plant parts, or plant cells further comprising a locus conversion or an additional trait. As discussed in the rejection under 35 USC 112(b) above, “maize variety BDAX4615” and, thus, “maize line BDAX4615”, the plant from which these claimed plants are made, encompasses a plant with an unspecified number of locus conversions and/or additional trait and that “a” means one or more than one. The plants of claims 6-8 and 16 can have any number of locus conversions and/or additional traits relative to “maize variety BDAX4615” and, thus, “maize line BDAX4615”, i.e., they can have any number of locus conversions and/or desired traits relative to a plant that can have any number of locus conversions and/or additional traits.
The specification describes no structural features that distinguish a maize plant that belongs to the genus of plants of “maize line BDAX4615” or “maize line BDAX4615” comprising a locus conversion or additional trait from other maize plants.
The genus encompassed by the current claims is almost infinitely broad. Applicant has reduced to practice only one single species that falls within the genus: the plant that was used to produce the data in Table 1. This single species having been reduced to practice is not sufficient to provide an adequate written description across the full breadth of the current claims.
Hence, Applicant has not, in fact, described the full scope of plants of “maize line BDAX4615” or plants of “maize line BDAX4615” comprising a locus conversion or desired trait, 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. 35 USC 112 requires that the specification have a written description of the invention:
35 U.S.C. 112 Specification.
(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 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 a complete 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 also fails to satisfy the written description requirement of 35 U.S. Code § 112(a) 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 because applicant failed to provide the breeding history for maize variety BDAX4615. A plant variety is defined by both its genetics (i.e., its breeding history) and its traits. However, the instant 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 variety.
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 an incomplete 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 phenotype of the claimed plant for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 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 (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification to provide the breeding history used to develop the instant variety or cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant variety. For example, if Applicant’s breeding history uses proprietary line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should 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 part A is addressed by claim amendments to no longer recite variety (response pg 8).
This is not found persuasive because the specification defines maize BDAX4615 as a variety in Table 1, which is the table describing BDAX4615’s traits. A portion of Part A of the rejection can be overcome by amending Table 1 to replace “variety” with --line--.
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, and in re Lundak and that the information should be obtained via a 105 request (response pg 8-16).
This not found persuasive.
While Applicant urges that the deposit provides 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 were needed, then a phenotype table 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 corn 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.
Applicant providing phenotype and/or parental information as a response to a Request for Information would also not be sufficient for examination, as a genetic analysis on the claimed plant and plants with the same phenotype or a phenotype that makes obvious the claimed plant would still be needed.
Further, a response to a Request for Information may be filed as a trade secret, and expunged from the application. Phenotype and/or parental information provided only as a trade secret does not inform the public about critical genetic description about the claimed plant. If a deposit were all that is required to describe a corn plant, then every future corn breeder would need to obtain seed of each and every patented corn plant and perform a phenotypic comparison and genetic analysis to determine if there is art on any corn plant they invent.
Further, 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 a corn plant do not exclude future inventors from of a description of a prior art corn plant.
Lastly, information provided in a response to a Request for Information is not part of the specification.
Phenotypic and parental (genetic) information as part of the specification and a deposit are all necessary parts of the description of a plant line.
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 line.
Applicant has not provided evidence saying that in the plant line art the breeding history is not considered part of the description of a plant line. 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).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6-7 are rejected under 35 U.S.C. 112(d) or 35 U.S.C. 112(pre-AIA ), fourth paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
Parent claim 2 is drawn to a plant of maize variety BDAX4615. Dependent claim 6 is drawn to a plant having all of the physiological and morphological characteristics of the plant of claim 2 and further comprising a desired trait. Because the plant of claim 6 further comprises a desired trait it does not have all of the physiological and morphological characteristics of the plant of claim 2. The claim thus fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Response to Arguments
Applicant urges that claim 6 is amended (response pg 16).
This is not found persuasive for the reasons above.
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 1-20 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 Bhatnagar et al (2021, US 10,905,068) taken with the evidence of each of Popi (2009, US 7,473,826), Page (2016, US 9,313,970), Popi (2011, US 7,872,183), Page (2011, US 8,035,006), Popi (2012, US 8,324,476), Johnson (2007, US 7,211,717), and Page (2015, US 8,969,677).
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
The claims are drawn to a plant, seed, plant part, or cell of maize line BDAX4615 or plants, seeds, plant parts, or cells derived from said variety, and methods that utilize said variety. The claims are interpreted as detailed in the 35 USC 112(a) and (b) rejections above.
The determination for the closest prior art was made using characteristics that do not vary under different environmental conditions in an analysis of three corn varieties. Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INKI1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction, anther color, presence of a glume band, ear shape, husk bract length, fresh and dry husk colors, endosperm type, and endosperm color.
‘068 teaches plants, seeds, plant parts, or cells of corn variety CV810674 (Table 1). Like the instantly claimed plant, CV810674 has pink anthers. CV810674 thus appears to be a plant, seed, plant part, or cell of maize variety BDAX4615, given the definitions provided in the instant specification.
Claims 4,1, 2, 8, 10, 11, 18 and 20 of ‘068 are identical to the instant claims 1-3, 10-11, 16-17 and 19, respectively, except for the name of the variety.
The plant parts of claim 3 of ‘068 are species of the genus of plant parts claimed in instant claim 4. The F1 seed of claim 8 of ‘068 is a species of the genus of seeds produced on BDAX4615 claimed in instant claim 5. The plants further comprising a locus conversion of claims 11 and 13-15 of ‘068 are species of the genus of BDAX4615 plants further comprising an additional trait or locus conversion claimed in instant claims 6 and 8 and the plants claimed in claim 11 of ‘068 make obvious the backcrossing method claimed in instant claim 15, as this is one method of producing single locus converted plants. The plants and seeds further comprising a transgene of claims 5 and 12 of ‘068 species of the genus claimed in instant claim 7. The method of instant claim 9 is made obvious by the process claimed to produce the seed in ‘068’s claim 8.
Instant claims 12-14 are made obvious by the process claimed in ‘068’s claim 17, as marker assisted breeding involves genotyping seeds or plants use din plant breeding methods.
The methods of applying plant breeding protocols or making a doubled haploid of claims 16-17 of ‘068 are species of the methods of applying plant breeding protocols of instant claims 18 and 20.
Response to Arguments
Applicant urges that the claims are amended (response pg 16).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Applicant urges that there are many differences between the claims and the prior art, including the genetic of the seed deposit (response pg 16).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Claims 1-20 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 Fangl et al (2020, US 10,653,096) taken with the evidence of each of Popi (2009, US 7,473,826), Page (2016, US 9,313,970), Popi (2011, US 7,872,183), Page (2011, US 8,035,006), Popi (2012, US 8,324,476), Johnson (2007, US 7,211,717), and Page (2015, US 8,969,677).
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
The claims are drawn to a plant, seed, plant part, or cell of maize line BDAX4615 or plants, seeds, plant parts, or cells derived from said variety, and methods that utilize said variety. The claims are interpreted as detailed in the 35 USC 112(a) and (b) rejections above.
The determination for the closest prior art was made using characteristics that do not vary under different environmental conditions in an analysis of three corn varieties. Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INKI1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction, anther color, presence of a glume band, ear shape, husk bract length, fresh and dry husk colors, endosperm type, and endosperm color.
‘096 teaches plants, seeds, plant parts, or cells of corn variety PH41MH (Table 1, claim 1). Like the instantly claimed plant, PH41MH has pink anthers. PH41MH thus appears to be a plant, seed, plant part, or cell of maize variety BDAX4615, given the definitions provided in the instant specification.
The plants, seeds and plant parts of ‘096 claim 1 make obvious the instant claims 1-3, except for the name of the variety. Claims 3, 7, 10, 12-13 and 15 of ‘096 are identical to instant claims 5, 8, 10-11, and 19-20, respectively, except for the name of the variety.
The plant parts of claim 2 of ‘096 are species of the genus of plant parts claimed in instant claim 4. The converted plants of claim 10 of ‘096 are species of the genus of converted BDAX4615 plants claimed in instant claim 6; they make the plant of instant claim 7 obvious as many of the listed traits, including herbicide and insect resistance are commonly conferred by transgenes. The method of instant claim 9 is made obvious by the process claimed to produce the seed in ‘096’s claim 3.
‘096 teaches methods involving crossing and genotyping as part of applying plant breeding techniques to their plant (column 15, line 12, to column 17, line 37), teaching species of instant claims 12-14.
The plants claimed in claim 10 of ‘096 make obvious the backcrossing method claimed in instant claim 15, as this is one method of producing single locus converted plants, and the plants produced are species of the genus of plants claimed in instant claim 16.
The plants and seeds further comprising a transgene of claims 5 and 12 of ‘096 species of the genus claimed in instant claim 7. The method of instant claim 9 is made obvious by the process claimed to produce the seed in ‘096’s claim 8.
Instant claims 12-14 are made obvious by the process claimed in ‘096’s claim 17, as marker assisted breeding involves genotyping seeds or plants used in plant breeding methods.
The methods of applying plant breeding protocols or making a doubled haploid of claims 16-17 of ‘096 are species of the methods of applying plant breeding protocols of instant claims 18 and 20. The methods that including making doubled haploids of ‘096’s claims 14-15 make obvious the method of making doubled haploids of instant 18.
Response to Arguments
Applicant urges that the claims are amended (response pg 16).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Applicant urges that there are many differences between the claims and the prior art, including the genetic of the seed deposit (response pg 16-17).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Claims 1-20 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 Miller (2010, US 7,642,427) taken with the evidence of each of Popi (2009, US 7,473,826), Page (2016, US 9,313,970), Popi (2011, US 7,872,183), Page (2011, US 8,035,006), Popi (2012, US 8,324,476), Johnson (2007, US 7,211,717), and Page (2015, US 8,969,677).
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection as set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
The claims are drawn to a plant, seed, plant part, or cell of maize variety BDAX4615 or plants, seeds, plant parts, or cells derived from said variety, and methods that utilize said variety. The claims are interpreted as detailed in the 35 USC 112(a) and (b) rejections above.
The determination for the closest prior art was made using characteristics that do not vary under different environmental conditions in an analysis of three corn varieties. Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INKI1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction, anther color, presence of a glume band, ear shape, husk bract length, fresh and dry husk colors, endosperm type, and endosperm color.
‘427 teaches plants, seeds, plant parts, or cells of corn variety CV810674 (Table 1). Like the instantly claimed plant, CV810674 has pink anthers. CV810674 thus appears to be a plant, seed, plant part, or cell of maize variety BDAX4615, given the definitions provided in the instant specification.
Claims 1and 3 of ‘427 is identical to the instant claims 1 and 10, respectively, except for the name of the variety. The plants and plant parts of claim 2 of ‘427 make obvious the plants and plant parts of instant claims 2-3. It would be obvious to one of skill in the art that plants parts would include pollen, silk, tassels, anthers or ovules, making instant claim 4 obvious.
The F1 hybrid of claim 3 of ‘427 is a species of the maize seed of instant claim 5. The plant claimed in claim 9 of ‘427 are species of the plants of instant claims 6 and 8, and the plants claimed in claims 15-16 of ‘427 are species of the plant of instant claim 7. The method of claim 11 of ‘427 lists two alternatives, one of which is the method of instant claim 9. The maize plant in claim 4 lists two alternatives, one of which is the plant of instant claim 11. The methods of claims 8-9 and 17 of ‘427 are species of the methods of instant claims 15-16 and 18, respectively.
The methods listed in claim 19 of ‘427 include methods listed in instant claim 18. Such methods include those that involve identifying polymorphisms in the plant or its progeny, making instant claims 12-14 obvious.
It would be obvious to one of ordinary skill in the art to produce commodity products like starch, meal, flour or oil, as this is a routine use of corn seed making instant claim 19 obvious.
Response to Arguments
Applicant urges that the claims are amended (response pg 17).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Applicant urges that there are many differences between the claims and the prior art, including the genetic of the seed deposit (response pg 17).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 7,642,427 taken with the evidence of each of Popi (2009, US 7,473,826), Page (2016, US 9,313,970), Popi (2011, US 7,872,183), Page (2011, US 8,035,006), Popi (2012, US 8,324,476), Johnson (2007, US 7,211,717), and Page (2015, US 8,969,677). Although the claims at issue are not identical, they are not patentably distinct from each other.
Due to Applicant’s amendment of the claims, the rejection is modified from the rejection set forth in the Office action mailed 9 October 2025. Applicant’s arguments filed 9 January 2026 have been fully considered but they are not persuasive.
The claims are drawn to a plant, seed, plant part, or cell of maize variety BDAX4615 or plants, seeds, plant parts, or cells derived from said variety, and methods that utilize said variety. The claims are interpreted as detailed in the 35 USC 112(a) and (b) rejections above.
The determination for the closest prior art was made using characteristics that do not vary under different environmental conditions in an analysis of three corn varieties. Appendix A compares the descriptions of 1351729 in US 7,473,826 and US 9,313,970, of 94INKI1A in US 7,872,183, US 8,035,006 and US 8,324,476, and of 1285291 in US 7,211,717 and US 8,969,677. The characteristics in bold are those that differ in the descriptions of at least one corn variety; these characteristics are those that are affected by the environmental conditions under which a plant is grown. The characteristics not in bold are those upon which this determination was made; these are brace root coloration, internode direction, anther color, presence of a glume band, ear shape, husk bract length, fresh and dry husk colors, endosperm type, and endosperm color.
‘427 teaches plants, seeds, plant parts, or cells of corn variety CV810674 (Table 1). Like the instantly claimed plant, CV810674 has pink anthers. CV810674 thus appears to be a plant, seed, plant part, or cell of maize variety BDAX4615, given the definitions provided in the instant specification.
Claims 1and 3 of ‘427 is identical to the instant claims 1 and 10, respectively, except for the name of the variety. The plants and plant parts of claim 2 of ‘427 make obvious the plants and plant parts of instant claims 2-3. It would be obvious to one of skill in the art that plants parts would include pollen, silk, tassels, anthers or ovules, making instant claim 4 obvious.
The F1 hybrid of claim 3 of ‘427 is a species of the maize seed of instant claim 5. The plant claimed in claim 9 of ‘427 are species of the plants of instant claims 6 and 8, and the plants claimed in claims 15-16 of ‘427 are species of the plant of instant claim 7. The method of claim 11 of ‘427 lists two alternatives, one of which is the method of instant claim 9. The maize plant in claim 4 lists two alternatives, one of which is the plant of instant claim 11. The methods of claims 8-9 and 17 of ‘427 are species of the methods of instant claims 15-16 and 18, respectively.
The methods listed in claim 19 of ‘427 include methods listed in instant claim 18. Such methods include those that involve identifying polymorphisms in the plant or its progeny, making instant claims 12-14 obvious.
It would be obvious to one of ordinary skill in the art to produce commodity products like starch, meal, flour or oil, as this is a routine use of corn seed making instant claim 19 obvious.
Response to Arguments
Applicant urges that the claims are amended (response pg 17).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Applicant urges that there are many differences between the claims and the prior art, including the genetic of the seed deposit (response pg 17).
This is not found persuasive because the specification describes “BDAX4615” as variety in Table 1. Thus, the interpretation detailed in the rejection under 35 USC 112b above applies.
Conclusion
No claim is allowed.
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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham, can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1663