DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
The amendments received on 11/26/2025 have been entered. Claims 14-21, 23, 26, 28, 32-33, and 35 are pending.
Claims 24 and 34 have been canceled.
Claims 14 and 33 have been amended.
Claim 35 has been newly added.
Claims 16-20 remain withdrawn from active consideration.
Claims 14-15, 21, 23, 26, 28, 32-33, and 35 are examined in this Office Action.
Objections and Rejections that are Withdrawn
All rejections to claims 24 and 34 have been rendered moot in light of Applicant’s cancelation of the claims.
The 35 USC 112(a) Written Description rejection to claims 14-15, 21, 23, 26, 28, and 32-33 for the recitation of “angiosperms” has been withdrawn in light of Applicant’s amendment to the claims. However, Applicant’s amendment to “angiosperms from an Asteraceae (Compositae) family” raises a new 35 USC 112(a) Written Description rejection.
The 35 USC 112(a) Written Description rejection to claims 14-15, 21, 23, 26, 28, and 32 for the recitation of “90% identity with SEQ ID NO: 1” has been withdrawn in light of Applicant’s amendment to the claims. However, claim 33 remains rejected under 35 USC 112(a) Written Description for the recitation of “90% identity with SEQ ID NO: 1”.
The text of those sections of Title 35, U.S. Code, not included in this action, can be found in a prior Office action.
Claim Rejections - 35 USC § 112
Written Description
Claims 14-15, 21, 23-24, 26, 28, and 32-33 remain rejected and claim 35 is newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a modified rejection necessitated by claim amendment. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are broadly drawn to a method for producing a parthenogenetic plant, comprising:
(a) introducing in one or more plant cells a parthenogenetic allele for expression of a parthenogenesis (PAR) protein comprising a sequence according to SEQ ID NO: 1 or a homologous or orthologous sequence thereof, wherein the parthenogenetic allele comprises an egg cell specific promoter operably linked to a sequence encoding the PAR protein, wherein the PAR protein is functional in parthenogenesis, wherein the PAR protein comprises a zinc finger C2H2-type domain having SEQ ID NO: 37 and an EAR motif having SEQ ID NO: 58 or 59, resulting in expression of the PAR protein in an egg cell, and wherein the one or more plant cells are angiosperms from an Asteraceae (Compositae) family;
(b) selecting a plant cell comprising the parthenogenetic allele ; and
(c) regenerating an angiosperm plant from said plant cell;
wherein the parthenogenetic allele is integrated in the genome of the plant cell; wherein the parthenogenetic allele comprises SEQ ID NO: 5 or a variant thereof having at least 90% sequence identity with SEQ ID NO: 5 over their entire length; wherein the plant cell is not of the species Taraxacum officinale sensu lato; wherein the plant cell is from a family selected from the group consisting of Brassicaceae, Cucurbitaceae, Fabaceae, Gramineae, Solanaceae, Asteraceae (Compositae), Rosaceae and Poaceae; wherein the produced parthenogenetic plant is further capable of apomeiosis; wherein the parthenogenetic allele is introduced by chemical mutagenesis or targeted gene editing; wherein the egg cell specific promoter comprises a promoter sequence of the egg-cell specific gene EC1.1, EC1.2, EC1.3, EC1.4, or EC1.5; wherein the PAR protein comprises an amino acid sequence having at least 90% identity with SEQ ID NO: 1; wherein the PAR protein comprises an amino acid sequence having at least 95% identity with SEQ ID NO: 1 over their entire length.
Applicant describes:
The identification of PAR proteins in several plants (Specification, Table 1, page 42).
The presence of a MITE or MITE-like sequence being indicative for the parthenogenic phenotype (Specification, page 48, lines 4-6).
A promoter sequence of a PAR gene may be replaced by the promoter of the Taraxacum Par allele. Upon introduction, plants will obtain the parthenogenesis trait (Specification, , page 48, lines 9-13).
Applicant has not described:
Any reduction to practice for causing parthenogenesis in an angiosperm from an Asteraceae (Compositae) family other than lettuce (Specification, Example 2, pages 46-47).
Any reduction to practice for causing parthenogenesis by using a homologous or
orthologous sequence of SEQ ID NO: 1.
Any reduction to practice for causing parthenogenesis by using a variant of the parthenogenetic allele having at least 90% sequence identity with SEQ ID NO: 5.
Applicant has claimed an extremely large genus of angiosperm plants from an Asteraceae (Compositae) family. Asteraceae is a large family of flowering plants that consists of over 32,000 known species in over 1,900 genera within the order Asterales. The number of species in Asteraceae is rivaled only by the Orchidaceae, and which is the larger family is unclear as the quantity of extant species in each family is unknown. The Asteraceae were first described in the year 1740 and given the original name Compositae. The family is commonly known as the aster, daisy, composite, or sunflower family (iNaturalist, https://www.inaturalist.org/taxa/47604-Asteraceae, accessed 02/13/2026) .
Most species of Asteraceae are herbaceous plants, and may be annual, biennial, or perennial, but there are also shrubs, vines, and trees. The family has a widespread distribution, from subpolar to tropical regions, in a wide variety of habitats. Most occur in hot desert and cold or hot semi-desert climates, and they are found on every continent but Antarctica (iNaturalist, https://www.inaturalist.org/taxa/47604-Asteraceae, accessed 02/13/2026).
It is noted that at the time of filing the Applicant had only reduced to practice the transformation of lettuce. Hypothetical host plants do not provide evidence of a reduction to practice of a representative number of species across the breadth of the claimed genus of all angiosperms from an Asteraceae (Compositae) family. A Written Description rejection is based on what the Applicant was in possession of at the time of filing. Additionally, with this in mind, the Applicant and author Underwood (Underwood et al., Nature Genetics, 2022, Vol. 54, pp. 84-93, see List of References Cited by Examiner dated 11/20/2023) describes introducing the Taraxacum PAR promoter (SEQ ID NO: 2) in the PAR homolog of Lactuca sativa (lettuce) to induce parthenogenesis. The PAR::Lssex construct led to seed production and tetraploid offspring in four independent transformants, demonstrating that the Taraxacum PAR promoter can invoke a lettuce gene to induce parthenogenesis (Results section, pp. 88-90). Taraxacum officinale (dandelion), Lactuca sativa (lettuce), and Hieracium piloselloides (hawkweed) are related species, all belonging to the Family Asteraceae (Supplementary Figure 15, page 18). Yet, according to the Peer Review Information (page 26), Underwood describes that they were unable to transform the Hieracium LoP (Loss of Parthenogenesis) genotype, noting that the lettuce homolog is phylogenetically more distant from dandelion than hawkweed. This shows the unpredictability of the claimed invention even in related species of angiosperms from the Asteraceae (Compositae) family. Thus, Applicant did not actually possess the successful transformation of Hieracium at the time of filing, but was in possession of the successful transformation of lettuce.
The instant specification does not describe any homologous or orthologous sequence of the
amino acid sequence of SEQ ID NO: 1 that is capable of inducing parthenogenesis in a plant. The instant specification (Example 2, page 47, lines 21-28) demonstrates that the Par allele gene of Taraxacum officinale is by itself sufficient to induce embryo formation in lettuce. The instant specification further states that “similar results are expected when the lettuce homolog (SEQ ID NO: 22) is used for plant
transformation in the same way, e.g., transforming said lettuce plant with a vector comprising a T-DNA
region comprising a EC1.1 promoter of Arabidopsis thaliana driving expression of a sequence encoding the lettuce homologue (SEQ ID NO: 22) with a 35S terminator and a neomycin phosphotransferase gene (nptll) for selection”. However, Ali (Ali et al., 2019, Frontiers in Plant Science, Vol. 10, pp. 1-14, see List of References Cited by Examiner dated 09/11/2024) describes that the identification and construction of in-silico promoter models has enabled more accurate prediction of gene expression, whereas the in-silico predictions of gene regulatory events must be validated experimentally (Ali, page 3, left column). The use of SEQ ID NO: 22 to induce embryo formation in lettuce was not reduced to practice in lettuce or in any other plant.
A BLAST® of instant sequence SEQ ID NO: 1 shows several hypothetical and unnamed proteins that would not be recognized in the art as homologous or orthologous sequences of the PAR protein of instant sequence SEQ ID NO: 1 (see BLAST® results below). It is also noted that only one protein, hypothetical protein LXL04_019396 [from Taraxacum kok-saghyz], falls within the at least 90% sequence identity with SEQ ID NO: 1 as required by claim 33.
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The instant specification does not describe any other sequence having at least 90% sequence identity with SEQ ID NO: 5, or a variant thereof, that is capable of causing parthenogenesis. A BLAST® of instant sequence SEQ ID NO: 5 discloses two short (36 and 39 nucleotides, respectively) sequences that would not be recognized in the art as variants thereof of instant sequence SEQ ID NO: 5 (see BLAST® results below).
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The instant specification describes the domains or motifs within SEQ ID NO: 5 that are required for causing parthenogenesis as an egg cell specific promoter operably linked to a sequence encoding a PAR protein, wherein the PAR protein comprises a zinc finger C2H2-type domain having SEQ ID NO: 37 and an EAR motif having SEQ ID NO: 58 or 59. Liu (Liu et al., 2022, International Journal of Molecular Sciences, Vol. 23, pp. 1-15, see List of References Cited by Examiner dated 04/08/2024) describes the C2H2-type zinc finger proteins as playing a critical role in many biological functions, including DNA/RNA binding, protein interactions, and transcriptional regulation. Additionally, the EAR motif in C2H2 zinc finger proteins is essential for transcriptional inhibitory activity (page 3, paragraph 2). Liu concludes that most members of C2H2 zinc finger proteins function as repressors through the EAR motif (Conclusions, pages 9 and 10).
Additionally, Jiao (Jiao et al., 2020, BMC Plant Biology, Vol. 20(401), pp. 1-17) describes C2H2 zinc finger proteins (C2H2 ZFPs) as playing vital roles in shaping many aspects of plant growth and adaptation to the environment. Plant genomes harbor hundreds of C2H2 ZFPs, which compose one of the most important and largest transcription factor families in higher plants (Jiao, Abstract/Background, page 1).
Jiao identified 218 C2H2 type ZFPs in Medicago truncatula. The identified ZFPs exhibit high variation in motif arrangement and expression pattern, suggesting that the short C2H2 zinc finger motif has been adopted as a scaffold by numerous transcription factors with different functions to recognize cis-elements. Several C2H2 ZFPs were identified that are specifically expressed in certain tissues, such as the nodule, seed, and flower (Jiao, Abstract/Results, page 1).
Jiao describes that C2H2 ZFPs mainly play a role in controlling the transcription of target genes, serving as typical transcription factors. The ethylene-responsive element binding factor-associated amphiphilic repression motif (EAR) is often found in C2H2 ZFPs, thereby enabling transcriptional repression functions of C2H2 ZFPs (Jiao, Background, page 1, right column).
Jiao further describes that Medicago truncatula is a model legume species that is phylogenetically close to the forage species alfalfa (Medicago sativa). In M. truncatula, only a few C2H2 ZFPs have been characterized, such as PALM1/IRG1 and REGULATOR OF SYMBIOSOME DIFFERENTIATION (RSD), both of which have a single C2H2 motif at the N-terminus and an EAR motif at C-terminus. PALM1/IRG1 plays an important role in determining the M. truncatula compound leaf pattern and epicuticular wax metabolism, whereas RSD controls symbiosome differentiation during nodule development (Jaio, page 2, left column, third full paragraph).
In M. truncatula, Jiao found a total of 218 ZFPs, of which 151 had only one C2H2 zinc finger motif. The EAR motif connects transcription suppressor TPL/TPL-like proteins, and thus enables transcription repression functions of the coding genes. The EAR motif is often found in ZFP genes. Among 151 single C2H2 ZFPs, 74 contained no EAR, 60 contained one EAR, and 17 contained multiple EAR motifs (Jaio, page 2, left column, fourth full paragraph).
In addition, Chen (Chen et al., 2026, Planta, Vol. 263(43), pp. 1-15) describes that C2H2-zinc finger proteins (C2H2-ZFPs) are involved in the regulation of plant development and stress resistance. However, there are few studies on the effect of C2H2-ZFPs on the regulation of floral fragrance. Petunia hybrida has become an ideal model plant for studying floral volatile benzenoids/phenylpropanoids (FVBP) metabolism. To gain insight into the participation of C2H2-ZFPs in the regulation of floral fragrance in petunia, Chen performed a genome-wide identification and characterization of C2H2-ZFP genes. A total of 96 C2H2-ZFP genes were identified from the genome of Petunia axillaris, one wild parent of P. hybrida, and their gene structure, conserved motif, phylogenetic relationship, cis-acting elements were analyzed. The C2H2 domain was conserved in all C2H2-ZFPs, while the EAR domain was present in 33 C2H2-ZFPs (Chen, Abstract, page 1).
Thus, the combination of Liu, Jaio and Chen show the commonality of C2H2 zinc finger proteins and EAR motifs performing a variety of functions throughout the plant kingdom. It should be noted that neither the zinc finger nor the EAR motif has any known connection to parthenogenesis as required by the claims. Therefore, sufficient structure/function analysis is not provided. Given that there is no description of structures that are correlated with the required function, there is not an adequate description to support the breadth of the claim.
The genus of PAR proteins is listed in Table 1 as SEQ ID NOs: 1, 6, 11, 28-32, and 39-57 (pages
41-42). The specification does not provide any information about the conserved domains of the PAR
proteins that confer parthenogenetic activity. The only conserved domains described are the zinc finger
and the EAR motif, neither of which is sufficient for causing parthenogenesis. The Applicant did not
reduce to practice any of these purported PAR protein sequences other than SEQ ID NO: 1. Given that there have not been an adequate number of species reduced to practice to be representative of the broad genus, there is not an adequate description to support the breadth of the claim.
Response to Arguments
Applicant’s arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant states that claim 14 has been amended to include the subject matter of claim 34.
However, Applicant’s amendment to claim 14 did not address the 35 USC 112 Written Description rejection of the Non-Final Rejection dated 08/28/2025 of “a homologous or orthologous sequence thereof.” The instant Specification lists numerous orthologous or homologous PAR proteins (pages 16-18 and Table 1, page 42, instant SEQ ID NOs: 39-57); however, none of them share the at least 90% identity with SEQ ID NO: 1 as required by claim 33 (see search results for instant sequence SEQ ID NO: 1, below), nor were any of them reduced to practice.
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Additionally, Applicant’s arguments did not address the rejection to claim 21 of a sequence having at least 90% sequence identity with SEQ ID NO: 5, or a variant thereof, that is capable of causing parthenogenesis. Applicant has reduced to practice the full-length sequence of SEQ ID NO: 5 in the transformation of lettuce, which is not representative of the broadly claimed genus of “at least 90% sequence identity with SEQ ID NO: 5, or a variant thereof “.
Lack of Scope of Enablement
Claims 14-15, 21, 23-24, 26, 28, and 32-33 remain rejected and claim 35 is newly rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for causing parthenogenesis by transferring the whole PAR gene (SEQ ID NO: 5) via cross-pollination of Taraxacum (Example 4, Specification, pages 48-49), does not reasonably provide enablement for a homolog or ortholog of SEQ ID NO: 1 (PAR allele protein) inducing parthenogenesis in all angiosperms from the Asteraceae (Compositae) family. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a modified rejection necessitated by claim amendment. All dependent claims are included in this rejection unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are broadly drawn to a method for producing a parthenogenetic plant, comprising:
(a) introducing in one or more plant cells a parthenogenetic allele for expression of a parthenogenesis (PAR) protein comprising a sequence according to SEQ ID NO: 1 or a homologous or orthologous sequence thereof, wherein the parthenogenetic allele comprises an egg cell specific promoter operably linked to a sequence encoding the PAR protein, wherein the PAR protein is functional in parthenogenesis, wherein the PAR protein comprises a zinc finger C2H2-type domain having SEQ ID NO: 37 and an EAR motif having SEQ ID NO: 58 or 59, resulting in expression of the PAR protein in an egg cell, and wherein the one or more plant cells are angiosperms from an Asteraceae (Compositae) family;
(b) selecting a plant cell comprising the parthenogenetic allele ; and
(c) regenerating an angiosperm plant from said plant cell.
The full scope of the claimed invention is not enabled because it is unpredictable whether and
how any homologous or orthologous sequence of the amino acid sequence of SEQ ID NO: 1 would be capable of inducing parthenogenesis in all angiosperm plants from an Asteraceae (Compositae) family. As stated in the Written Description rejection above, Underwood (2022) describes introducing the Taraxacum PAR promoter (SEQ ID NO: 2) in the PAR homolog of Lactuca sativa (lettuce) to induce parthenogenesis. Taraxacum officinale (dandelion), Lactuca sativa (lettuce), and Hieracium piloselloides (hawkweed) are related species, all belonging to the Family Asteraceae (Supplementary Figure 15, page 18), yet Underwood was unable to transform the Hieracium LoP (Loss of Parthenogenesis) genotype. This shows the unpredictability of the claimed invention even in related species. At the time of application, it was unpredictable whether any homologous or orthologous sequence of the amino acid sequence of SEQ ID NO: 1 is capable of inducing parthenogenesis in any angiosperm plant from an Asteraceae (Compositae) family other than lettuce. Therefore, it would require undue experimentation for one of skill in the art to use trial and error to determine which purported PAR proteins would be capable of conferring parthenogenesis.
Additionally, the specification does not describe any sequence having less than 100% sequence identity with SEQ ID NO: 5, or a variant thereof, that is capable of causing parthenogenesis. Example 4 of the instant specification teaches the full-length sequence SEQ ID NO: 5 causing parthenogenesis in Taraxicum brevicomiculatum (page 48-49). It is unpredictable whether and how a sequence having less than 100% identity to SEQ ID NO: 5, or a variant thereof, would function to cause parthenogenesis in a plant, since induction of parthenogenesis relies on the presence of specific nucleotides and nucleotide sequence motifs in a particular arrangement to mediate parthenogenetic function. For example, Underwood (Underwood et al., 2022, Nature Genetics, Vol. 54, pp.84-93) describes a conserved MITE 1,335-bp insertion in the upstream promoter region present in all apomicts and absent in all sexuals (page 88, left column, third paragraph).
In the instant case, the specification does not provide sufficient guidance with respect to how to alter the nucleotide sequence of SEQ ID NO: 5 in a manner that does not disrupt its ability to induce parthenogenesis. Absent such guidance one skilled in the art would have to make each of the polynucleotides having at least 90% identity to SEQ ID NO: 5, and then test the ability of each polynucleotide variant to induce parthenogenesis, in order to determine whether and how a polynucleotide variant can be used to induce parthenogenesis. Such a trial-and-error approach to practicing the claimed invention would constitute undue experimentation.
Response to Arguments
Applicant’s arguments filed 11/26/2025 have been fully considered but they are not persuasive.
Applicant states that claim 14 has been amended to include the subject matter of claim 34.
However, Applicant’s amendment to claim 14 did not address the 35 USC 112 Enablement rejection of the Non-Final Rejection dated 08/28/2025 to “SEQ ID NO: 1 or a homologous or orthologous sequence thereof.” Applicant has reduced to practice the full-length sequence of SEQ ID NO: 1 in the transformation of lettuce, which is not representative of the broadly claimed genus of “a homologous or orthologous sequence thereof “.
Additionally, Applicant’s arguments did not address the rejection to claim 21 of a sequence having at least 90% sequence identity with SEQ ID NO: 5, or a variant thereof, that is capable of causing parthenogenesis. Applicant has reduced to practice the full-length sequence of SEQ ID NO: 5 in the transformation of lettuce, which is not representative of the broadly claimed genus of “at least 90% sequence identity with SEQ ID NO: 5, or a variant thereof “.
Summary
No claim is allowed.
Claims 14-15, 21, 23, 26, 28, 32-33, and 35 are free of the prior art, due to the failure of the prior art to teach or suggest instant sequences SEQ ID NO: 1 or SEQ ID NO: 5 inducing parthenogenesis in any plant. The Examiner believes there might be allowable subject matter, but the claims would need to be drafted in a way to avoid 112 issues. For example, Applicant may want to limit the broad genus of plants to lettuce, and adopt the 95% sequence identity language (see claim 35).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA MEADOWS whose telephone number is (703)756-1430. The examiner can normally be reached Monday - Friday 9:00 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTINA MEADOWS
Examiner
Art Unit 1663
/CHRISTINA L MEADOWS/Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663