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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 27February2026 has been entered.
Election/Restrictions
[Copied from the Nonfinal 08January2025 → ] Applicant’s election without traverse of Group I, four haplotypes, the population being from a plurality of F1 hybrids, a first and second MiMe plant, each parent having two “MiMe alleles” at all of REC8, SPO11-1, and CYCA1/TAM (corresponding to SEQ ID NOs: 8, 25, and 82), introducing genetic modifications into the MiMe loci, clonal gamete from the second parent, and complete MiMe in the reply filed on December 6, 2024 is acknowledged.
Claims 31-33, 35-38, 40, 42-44, 46-49, 51 (as filed 27February2026) REMAIN withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group of invention or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 6, 2024.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Status of the Claims
The amendments and arguments filed 27February2026 are acknowledged and have been fully considered. Claims 2-3, 5-7, 10-11, 13-15, 17-30 were canceled. Claims 1, 4, 8-9, 12, 16, 31-52 are pending. Claims 31-33, 35-38, 40, 42-44, 46-49, 51 remain withdrawn. Claims 1, 8-9, 16 are currently amended. Claims 4, 12, 31-52 were previously amended. Claims 1, 4, 8, 9, 12, 16, 34, 39, 41, 45, 50, 52 are examined.
Priority
To the extent that these claims encompass potato plants or are amended to be limited to potato plants, the effective filing date will need to be reviewed (as was discussed for application 18504893 (published as US20240147926A1; Attny Dkt. No. 19707-20004.00) wherein the Office/this Examiner took the position that claims requiring diploid MiMe potato plants and tetraploid progeny potato (true) seed therefrom had the effective filing date equal to the actual filing date of the nonprovisional application and not, as Applicant requested, the actual filing date of the provisional application(s)). Please note that these claims continue to recite many plant types.
Context
The “Tardy Asynchronous Meiosis” (“TAM”) gene is a synonym in the art for the “CYCA1” gene, which is why they are often written as “CYCA1/TAM” or “TAM/CYCA1”.
The recitation of “the same or related species of plant” in the claims (see line 4 of claim 1) raises neither an objection or rejection herein because, in the context of plant breeding, the Office believes a person with ordinary skill in the art would understand this to mean the same species of plants or highly similar species of plants that may be crossed (the example given in the specification is Solanum tuberosum crossed to Solanum chacoense which are “related species of [a potato] plant”, see ¶534 on page 391 of the specification).
Please note that Applicant’s application 18504917 (published as US20240150778, Attny Dkt. No. 19707-20003.00, now US Pat. No. 12365908) and Application No. 18504893 (published as US20240147926A1; Attny Dkt. No. 19707-20004.00, now US Pat. No. 12446503), which have overlapping priorities with this application, are also docketed to this Examiner. Please also note the Double Patenting issues raised of record (withdrawn in the Final Action dated 29August2025 in view of terminal disclaimers filed 08July2025 and approved 14July2025). Please note that the double patenting issues raised in the Final action 29August2025 and hereinbelow are with respect to continuation applications (i.e., “children” applications) of 18504917 (Appl. No. 1918163 being a child thereof) and 18504893 (Appl. No. 19208367 being a child thereof).
Further to page 12 of the Final dated 29August2025, and to ensure a clear record: “Apomixis” is generally understood as meaning asexual clonal reproduction through seeds (see D’ERFURTH et al. 2009 and 2010 of record). Synthetic apomixis can be achieved by: (1) apomeiosis (absence or alteration of meiosis, the result of which is unreduced 2n gametes), and (2) trigger embryo development by either1 (2a) parthenogenesis (skip fertilization such as with Baby Boom “BBM” genes2) or (2b) genome elimination (such as via CENH3 or MTL genes3 or other “haploid inducer scheme(s)”) then (3) endosperm development (with or without fertilization) (see D’ERFURTH et al. 20094, YIN et al.5, and XIONG et al.6). The Mitosis instead of Meiosis “MiMe” technique discussed throughout this specification and record is a method of downregulating three genes to synthetically/recombinantly cause (1) apomeiosis (the result of which is unreduced 2n gametes). There are various combinations of genes which, downregulated, may be used to effect “MiMe”: REC8/SYN1 + (SPO11-1 or PAIR1) + (CYCA1/TAM or OSD1)7. As stated by Applicant throughout the record, many of the art references that discuss “MiMe” do so in the context of combining the “MiMe” gene downregulation technique with (2a) parthenogenesis or (2b) chromosome elimination to achieve synthetic apomixis. So, utilization of “MiMe” does not necessarily mean that apomixis is achieved (because a reference to MiMe alone does not account for either (2a) parthenogenesis or (2b) genome elimination). Please see figure 1 of XIONG et al. and figure 1 of YIN et al. copied herein below which explain the use of MiMe gene downregulation for synthetic apomixis.
Figure 1 of XIONG et al.
PNG
media_image1.png
623
1007
media_image1.png
Greyscale
PNG
media_image2.png
574
997
media_image2.png
Greyscale
PNG
media_image3.png
93
767
media_image3.png
Greyscale
Figure 1 of YIN et al.
PNG
media_image4.png
824
1165
media_image4.png
Greyscale
As discussed within WANG et al. 20198 and XIONG et al.9, (1) MiMe is desirable for increasing heterosis/hybrid vigor because it prevents recombination (and thereby avoids the genetic segregation which causes hybrids to lose desirable traits over time/generations10), but crossing MiMe plants doubles the ploidy at each generation, so (2b) chromosome elimination techniques (e.g., via CENH3 or MTL) are needed if the increase in ploidy is not desired (e.g., in WANG et al. 2019, the goal was to get back to diploid offspring so the tetraploid progeny, which was obtained by self-fertilizing MiMe rice plants, were crossed with a CENH3-mediated chromosome elimination line).11 If increased ploidy had been the goal of WANG et al., they would have taken no further steps beyond obtaining tetraploid MiMe progeny—they would not have bothered to do the (2b) chromosome elimination step. Using MiMe with the intention of increasing ploidy is demonstrated by post-filing publication WANG et al. 2024 (there, in tomato, WANG et al. 2024 Figure 2 show crossing diploid, 2-haplotype MiMe plants to generate tetraploid, 4-haplotype clonal progeny)12 (WANG et al. 2024 Figure 2 is copied below).
PNG
media_image5.png
495
467
media_image5.png
Greyscale
Because self-fertilization of MiMe plants doubles the ploidy at each generation, it also causes the commercially undesirable results of low fertility of the offspring (e.g., observed by WANG et al. 201913) and/or low clonal seed rate. Ectopic expression of BBM genes in MiMe plants has been used to address both the low fertility issue14 and low seed set rate issue15 at least in rice (i.e., the use of ectopic BBM gene expression to trigger (2a) parthenogenesis has been successfully implemented in (1) MiMe rice plants to improve the fertility and seed set rates of MiMe progeny).
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the final office action dated 29August2025 that are not otherwise discussed herein are withdrawn. In particular:
RE ¶ 8: The obviousness rejection over D’ERFURTH et al. 2010, KRONHOLM et al., and WASHBURN et al. is withdrawn in view of the amendments to the claims by which Arabidopsis thaliana plants are no longer encompassed by the claims.
RE ¶ 9: The obviousness rejection over XIE et al., MIEULET et al., GUO et al., and WASHBURN et al. is withdrawn in view of Applicant’s argument that none of the cited references explicitly teach or suggest crossing MiMe plants (Applicant’s remarks primarily focused on XIE et al.). That is a fair criticism of the rejection of record and compensated for by WANG et al. 2019 (which is cited by XIE et al. at page 915 and cited within the new obviousness rejection hereinbelow). Applicant should also note that these claims are written in open-ended format and do not exclude the MIME plants comprising other gene mutations or using downstream parthenogenesis or genome elimination steps;
and
RE ¶ 10: The enablement rejection is withdrawn because, based on both the prior art and post-filing art as well as the prosecution history of (now) US Pat. Nos. 12365908 and 12446503, the Office believes that these broad claims raise more questions of possession rather than questions around undue trial and error experimentation. Please see the Written Description rejection hereinbelow.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 4, 8, 9, 12, 16, 34, 39, 45, 50 are rejected under 35 U.S.C. 103 as being unpatentable over WANG et al. (“Clonal seeds from hybrid rice by simultaneous genome engineering of meiosis and fertilization” 2019 Nature Biotechnology 37:283-286; of record IDS 08July2025 (hereinafter “WANG et al. 2019”)); D’ERFURTH et al.2010 (“The CYCLIN-A CYCA1/2/TAM is Required for the Meiosis I to Meiosis II Transition and Cooperates with OSD1 for the Prophase to First Meiotic Division Transition” 2010 PLoS Genetics 6(6): e1000989, 12 total pages; of record Form PTO-892 08January2025 (hereinafter “D’ERFURTH et al. 2010”)); WASHURN & BIRCHLER (“Polyploids as a ‘model system’ for the study of heterosis” 2013 Plant Reproduction 27(1): 1-5 doi:10.1007/s00497-013-0237-4); and GUO et al. (“Transcriptome analysis of neo-tetraploid rice reveals specific differential gene expressions associated with fertility and heterosis” 2017 Scientific Reports 7(40139): DOI:10.1038/srep40139 (11 total pages); of record IDS Form PTO-892 08January2025).
These claims (as elected) are generally directed toward methods of producing a population of tetraploid true seed with three or four haplotypes (claims 1+), and a population of tetraploid true seed with three or four haplotypes (claims 9+) by crossing two diploid parent “Mitosis Instead of Meiosis” (“MiMe”) plants that have genetic modifications within three genes (as elected: REC8, SPO11-1, and CYCA1/TAM) wherein the genetic modification eliminates the gene expression or the function of the encoded protein (Claims 1, 9, 34, 45). These claims are now (27February2026) amended to say that the plant is of a listed type. Please note that the listed plant types are very broad (encompassing over forty plants including cotton, maize, potato, rapeseed, rice, soybean, tomato, and wheat) (claims 1, 8, 9, 16 and those referring thereto). Certain levels of genetic uniformity are claimed (see claims 4, 12), dicot plants are claimed (now excluding Arabidopsis (claims dated 27February2026)) (see claims 41, 52), and certain particulars regarding haplotypes are claimed (see claims 39, 50). For completeness, and as noted above, these claims are written in open-ended format such that the MiMe plants may comprise other downregulated genes and/or ectopically expressed genes (e.g., ectopic expression of a BBM gene) and the methods encompass downstream (2a) parthenogenesis or (2b) genome elimination steps (i.e., taking (1) apomeiosis via MiMe through to apomixis).
WANG et al. 2019 teach generating diploid MiMe rice plants via downregulating therein the AtSYN1-ortholog-REC8 (referred to as just “REC8” therein), PAIR1, and OSD1 genes.16 WANG et al. 2019 self-fertilized the diploid MiMe plants and generated tetraploid progeny (seeds and plants).17 At Table 1 of WANG et al. 2019, it is reported that 100% of the MiMe progeny were tetraploid and, therefore, the tetraploid seed comprised “at least 90%” of the genetically uniform polyploid seed. WANG et al. used hybrid rice and explain that the whole goal of their work is heterosis (hybrid vigor) and fixing heterozygosity.18
WANG et al. 2019 do not teach the combination of MiMe genes which Applicant has elected for examination (AtSYN1/REC8-ortholog + APO11-1 + CYCA1/TAM). Also, WANG et al. 2019 diploid MiMe plants appear to both comprise the same two haplotypes, therefore, the tetraploid progeny of WANG et al. 2019 appear to have only two haplotypes. To that end, WANG et al. 2019 does not appear to teach that the diploid MiMe parent plants “together comprise three or four haplotypes” such that the tetraploid progeny comprise “three or four haplotypes”.
D'ERFURTH et al. 2010 teach MiMe via downregulation of AtSYN1/REC8 + APO11-1 + CYCA1/TAM (there, in Arabidopsis).19
WASHURN & BIRCHLER evidence increasing heterosis/hybrid vigor (therein progressive heterosis20) via increasing the plant’s haplotypes (as shown within Figure 1, copied below, a tetraploid plant that has four haplotypes A x B x C x D).
PNG
media_image6.png
474
997
media_image6.png
Greyscale
GUO et al. is cited to evidence that many lines (haplotypes) of rice were known to the prior art and heterosis in tetraploid rice plants was known21.
It would have been obvious to a person with ordinary skill in the art at the time this application was filed (a “POSA”) to substitute the MiMe gene combination used in WANG et al. 2019 for those taught by D’ERFURTH et al. 2010 because it would have been a “simple substitution of one known element (the MiMe gene combination used by D’ERFURTH et al. 2010) for another (the MiMe gene combination used by WANG et al. 2019) to obtain predictable results” (MPEP §2143(I)(B)). Further, in view of at least WASHURN & BIRCHLER and GUO et al., it would have been obvious to a POSA to utilize diploid MiMe plants that together have three or four haplotypes (and thereby generate tetraploid MiMe progeny having three or four haplotypes) because it would have been the “use of [a] known technique (increasing haplotypes) to improve similar methods/products (such as improve rice heterosis) in the same way” (MPEP §2143(I)(C)); “applying a known technique (increase haplotypes to increase heterosis) to a known method/product (WANG et al. 2019) ready for improvement to yield predictable results” (MPEP §2143(I)(D)); and at the very least “obvious to try” (MPEP §2143(I)(E)).
Please note that rice is a monocot, which is why claims 41 and 52 are not rejected here.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claim 1, 4, 8, 9, 12, 16, 34, 39, 41, 45, 50, 52 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 which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For clarity of the record, while “REC8” may be used to refer to an entire gene family22, it is understood from the specification, art, and record that the reference to “REC8” in the claims is meant to mean an ortholog of Arabidopsis SYN1/AtREC8-01.
As noted elsewhere herein and of record, the current claims (27February2026) encompass many types of plants (more than forty types of plants) and, therefore, these claims (as elected) encompass REC8/SYN1, SPO11-1, and CYCA1/TAM genes from many (40+) types of plants.
The “REC8”, “SPO11-1”, and “CYCA1” recitations in these claims are functional recitations (they are referring to genes that have the “REC8”/AtSYN1, “SPO11-1”, or “CYCA1”/TAM function in the context of mitosis or meiosis)—no structural requirement is recited in these claims for what the “REC8”, “SPO11-1”, or “CYCA1” gene(s) must have.
MiMe technology had been successfully implemented in several plants before the filing of this application (Arabidopsis thaliana23, rice (Oryza sativa)24, and corn (maize)25) and REC8, SPO11-1, and CYCA1/TAM genes were known well enough in the context of mitosis and meiosis that the prior art appears to have had a “well-established correlation between structure and function” for REC8, SPO11-1, and CYCA1/TAM genes (MPEP § 2163(II)(A)2163(3)(a)(i)(A)(C)(2))). Further, this specification provides Examples 1-2 and 10 regarding MiMe in potato which entered potato REC8, SPO11-1, and CYCA1/TAM gene sequences into the art.26 This specification also provides at ¶268, ¶271, and ¶282 (and the accompanying Tables) lists of accession numbers for supposed REC8, SPO11-1, and CYCA1/TAM genes from a breadth of plant types27.
However, (1) the plants for which accession numbers are identified are too small in number and diversity to be representative of the massive genus of plants being claimed (Solanaceae, Ericaceae, Rosaceae, and Poaceae families each comprise several thousand types of plants, with the Musaceae family having about one hundred types of plants) and (2) the specifically identified accession numbers which are given in the specification (for a particular type of plant) appear to be incomplete or inaccurate. For example, the specification identifies only one REC8 gene for some plants including Glycine max, but it had been known (since before this application’s filing) that certain plants contain two REC8 genes and this is the case for Glycine max: it has now been shown (post-filing) that Glycine max has two REC8 genes. WANG et al. 202528 identified the open reading frames Glyma.02G263700 and Glyma.14G057200 as the REC8 genes in G. max, but Applicant only identified UniProtKB Accession K7M545 as the G. max REC829 (which corresponds to Glyma.14G057200).
Taken together, the Office does not doubt that a skilled artisan could reasonably predict the general structure/sequence (motifs and domains) of a particular REC8, SPO11-1, or CYCA1/TAM gene or protein by having been given its function (i.e., by being told that a gene/protein has “REC8”, “SPO11-1” or “CYCA1/TAM” function in the context of mitosis or meiosis, an artisan could reasonably predict the structure of the corresponding polynucleotide or amino acid sequence). MPEP § 2163(II)(A)2163(3)(a)(i)(A)(C)(2). The issue that the Office can see is that neither the specification nor the prior art provides a basis for reasonably predicting the number of REC8, SPO11-1, or CYCA1/TAM genes that any particular plant type has. Said another way, if a skilled artisan had been told that “soybean has one REC8 gene” it is expected that the skilled artisan could, in view of this specification and prior art, reasonably predict the structure/sequence that the REC8 gene (and its encoded protein) would have. That same artisan, however, could not reasonably predict how many REC8 genes soybean has without actually doing sequencing and phylogenic analysis to find out. So, in the context of the number of REC8, SPO11-1, or CYCA1/TAM genes that any particular plant type has; neither the specification nor prior art provide enough information such that simply reciting function (i.e., stating the gene/protein has “REC8”, “SPO11-1”, or “CYCA1/TAM” function) is enough information for an artisan to “recognize or understand the structure” (MPEP § 2163(II)(A)2163(3)(a)(i)(A)(C)(2)) because there is no disclosed guidance for how to predict how many of the “REC8”, “SPO11-1”, or “CYCA1/TAM” genes are present within the plant. Being able to predict how many copies of the MiMe genes a plant has is important in the context of the claimed subject matter because the claimed genetic modifications must completely eliminate the expression of the MiMe genes (or render all encoded protein dysfunctional)—that cannot be done if it is not first known how many genes have to be downregulated (e.g., downregulate one REC8 gene to eliminate REC8 expression or downregulate two REC8 genes to eliminate REC8 expression).
In the interest of transparency, the noted example with soybean REC8 (the specification describing one REC8 gene whereas the post-filing art has confirmed that soybean has two REC8 genes) may not be the only error—the Examiner just noticed it when making an honest effort to review this voluminous record. Applicant is in the best position to know whether the specification is otherwise accurate (with respect to all of the claimed plant types and the supposed “REC8”, “SPO11-1”, or “CYCA1/TAM” gene sequences thereof which are listed in the specification at ¶¶268, 271, 282).
Absent evidence to the contrary, a skilled artisan at the time this application was filed would not reasonably believe Applicant was in possession of the full metes and bounds of the subject matter being claimed (namely, that Applicant was in possession of the (2) full repertoire of REC8, SPO11-1, and CYCA1 genes (1) in a representative sample of the vast breadth of plant types being claimed, sufficient to (2) eliminate expression of all of those genes and achieve “MiMe” (1) in a representative sample of the plant types being claimed).
Applicant may wish to consider reciting specific plant types and their corresponding REC8, SPO11-1, and CYCA1/TAM sequences (SEQ ID NOs) in the claims (which, for certain plant types, would at least overcome this Written Description rejection).
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 9, 12, 16, 45, 50, 52 (population of seed) REMAIN provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of co-pending application 19208367 (unpublished, Attny Dkt. No. 19707-20004.10) filed 14May2025 and of record in the IDS 08July2025 and Claims 1, 4, 8, 34, 39, 41 (methods) REMAIN provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-30 of co-pending application 19208367 (unpublished, Attny Dkt. No. 19707-20004.10) filed 14May2025 and of record in the IDS 08July2025.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 19208367 are specifically directed toward the potato species encompassed by the genus claims of this application (see claims 8 and 16 here reciting potato). There is nothing of record to suggest that the claims of 19208367 are materially different than the potato species of these claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Remarks 27February2026:
Applicant asks that this provisional rejected be held in abeyance (Remarks pages 36-37).
Claims 1, 4, 8, 34, 39, 41 (methods) REMAIN provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-50 of copending Application No. 19181163 (published as US20250250580A1; Attny Dkt. No. 19707-20003.10) filed 14May2025 and of record in the IDS 08July2025.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of 19181163 are directed toward a recited, non-elected species of these claims (maize (recited in claim 8) and with a mutation to OSD1 instead of CYCA1/TAM (see claim 1 at part (3)(i))) and, nonetheless, mutating OSD1 is an obvious variation of the claimed, elected invention (mutating CYCA1/TAM) in view of at least MIEULET et al. (discussed above) and XIE et al. (discussed above) who teach mutating CYCA1/TAM is an alternative to mutating OSD1 for generating a “MiMe phenotype”.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Applicant’s Remarks 27February2026:
Applicant asks that this provisional rejected be held in abeyance (Remarks pages 36-37).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Rebecca STEPHENS whose telephone number is (571)272-0070. The examiner can normally be reached Monday through Friday 8:30-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 See XIONG et al. “Synthetic apomixis: the beginning of a new era” 2023 Current Opinion in Biotechnology 79:102877 (19 total pages) on page 8, right column.
2 See XIONG et al. XIONG et al. “Synthetic apomixis: the beginning of a new era” 2023 Current Opinion in Biotechnology 79:102877 (19 total pages) at Table 3 on page 11 and YING et al. at Table 1 on page 3.
3 See XIONG et al. XIONG et al. “Synthetic apomixis: the beginning of a new era” 2023 Current Opinion in Biotechnology 79:102877 (19 total pages) at Table 3 on page 11 and YING et al. at Table 1 on page 3.
4 D’ERFURTH et al. 2009 at the right column on page 5
5 YIN et al. “Options for Engineering Apomixis in Plants” 2022 Frontiers in Plant Science 13:864987 doi:10.3389/fpls.2022.864987 at Figure 1 on page 4.
6 XIONG et al. “Synthetic apomixis: the beginning of a new era” 2023 Current Opinion in Biotechnology 79:102877 (19 total pages) at Table 3.
7 See YIN et al. “Options for Engineering Apomixis in Plants” 2022 Frontiers in Plant Science 13:864987 doi:10.3389/fpls.2022.864987 at the right column on page 2.
8 WANG et al. “Clonal seeds from hybrid rice by simultaneous genome engineering of meiosis and fertilization genes” 2019 Nature Biotechnology 37:283-286 https://doi.org/10.1038/s41587-018-0003-0; of record IDS 08July2025 and cited by of record XIE et al. at page 915.
9 XIONG et al. “Synthetic apomixis: the beginning of a new era” 2023 Current Opinion in Biotechnology 79:102877 (19 total pages) at Figure 1 on page 2.
10 XIONG et al. “Synthetic apomixis: the beginning of a new era” 2023 Current Opinion in Biotechnology 79:102877 (19 total pages).
11 WANG et al. 2019 at the left column on page 283 (including Abstract).
12 WANG et al. 2024 “Harnessing clonal gametes in hybrid crops to engineer polyploids genomes” 2024 Nature Genetics 56(6):1075-1079 https://doi.org/10.1038/s41588-024-01750-6 (of record IDS 24June2024) at Figure 2 on page 1078.
13 WANG et al. “Clonal seeds from hybrid rice by simultaneous genome engineering of meiosis and fertilization” 2019 Nature Biotechnology 37:283-286) at the right column on page 283.
14 KHANDAY et al. “A male-expressed rice embryogenic trigger redirected for asexual propagation through seeds” 2019 Nature 92(565): 91-95 (20 page document); of record IDS 08July2025.
15 WEI et al. “Synthetic apomixis with normal hybrid rice seed production” 2023 Molecular Plant 16:489-492.
16 WANG et al. (“Clonal seeds from hybrid rice by simultaneous genome engineering of meiosis and fertilization” 2019 Nature Biotechnology 37:283-286) at pages 283-285 including Figure 1 and Table 1.
17 WANG et al. (“Clonal seeds from hybrid rice by simultaneous genome engineering of meiosis and fertilization” 2019 Nature Biotechnology 37:283-286) at pages 283-285 including Figure 1 and Table 1.
18 WANG et al. 2019 such as at page 283 including the Abstract. Note that “fix” used throughout WANG et al. 2019 is short-hand for “fixation of hybrids” (right column on page 284).
19 D’ERFURTH et al. 2010 at the Abstract on page 1 and pages 1-2.
20 Progressive heterosis being, in general, the additional hybrid vigor in double-cross hybrids not found in their single-cross parents.
21 See, e.g., GUO et al. “Transcriptome analysis of neo-tetraploid rice reveals specific differential gene expressions associated with fertility and heterosis” 2017 Scientific Reports 7(40139): DOI:10.1038/srep40139 (11 total pages) at pages 2-3.
22 See WANG et al. 2023 “Genome-Wide Analysis of the Rad21/REC8 Gene Family in Cotton (Gossypium spp.)” 2023 Genes 14(993): 13 total pages https://doi.org/10.3390/genes14050993.
23 See D’ERFURTH et al.2010.
24 See WANG et al. 2019.
25 See ALBERTSEN et al. WO2017161264 (of record IDS 24June2024) at page 58.
26 For completeness, the specification provides Examples 1-2 and 10 for potato; Example 5 for corn/maize; and Example 7 for Arabidopsis. The specification also provides prophetic Examples (Example 3 for blueberry, Example 4 for blackberry, Example 6 for Banana, Example 11 for tomato, Example 12 for watermelon, and Example 13 for soybean.
27 See also Applicant’s Remarks 27February2026 at pages 26-34 listing the accession numbers of supposed REC8, SPO11-1, and CYCA1/TAM genes from a breadth of plant types.
28 WANG et al. “Simultaneous editing of SPO11-1, REC8, OSD1 yields aneutetraploid soybeans” 2025 Plant Biotechnology Journal 23: 3757-3759 doi:10.1111/pbi.70143; of record Form PTO-892 29August2025.
29 Specification at page 86 (line 12).