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 .
Election/Restrictions
[Copied from Nonfinal 21January2026 →] RE Groups: Applicant's election with traverse of Group I in the reply filed on 08December2025 (as supplemented by the reply filed 09January2025—the latter of which was only filed to ensure papers were properly signed) is acknowledged. The traversal is on the ground(s) that the claims all recite the same technical feature (part I), which is a special technical feature (part II) (Remarks 08December2025 at pages 3-4). This is not found persuasive in view of CN102177778 (cited in the Restriction/Unity of Invention requirement 08October2025) which is a publication by these inventors and teaches that rice grain containing a “ta-1” mutation has a thickened aleurone layer. Further to the rejections hereinbelow and, again, because CN102177778 is an inventor-publication, Applicant is welcomed to use declaration practice to explain (on the record) that the “TA-1” gene referred to in CN102177778 is not the “TA-1” (i.e., the Os05g43440) gene of this application. To be clear, without evidence to the contrary from Applicant, the Office maintains the assertion that the “TA-1” gene of CN102177778 is the same as the “TA-1” gene (i.e., the Os05g43440) gene of this application.
The requirement is still deemed proper and is therefore made FINAL.
Claims 28, 67; 32-33, 41; 38, 40, 42, 57; 44; 52 (← written in conformance with the Groups set forth in the Restriction/Unity of Invention requirement; i.e. 28, 32-33, 38, 40-42, 44, 52, 57, 67) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group of invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08December2025.
RE Species: Applicant’s election of mtSSB (and corresponding wild type sequence SEQ ID NO: 3 and mutant sequence SEQ ID NO: 8), endogenous gene, part (b) of claim 4 and SEQ ID NO: 5, part (a)(iii) and (c) of claim 7, rice, and part (a) of claim 17 in the reply filed on 08December2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
For clarity of the record, please see a summary of the claims (as examined and elected) provided below.
For Applicant’s response to this action, please also see the indication of allowable subject matter herein below and the Office’s suggestions as to how these claims may be amended (note that some of what the Office suggests requires the recitation of currently non-elected subject matter).
Status of the Claims
The claims filed 21May2026 are acknowledged and have been fully considered. Claims 2, 7, 40-41, 67 are now canceled (claims 3, 5-6, 8-16, 18-27, 29-31, 34, 36-37, 39, 43, 45-51, 53-56, 60-63, 65-66 were previously canceled). Claims 68-72 are newly presented. Claims 1, 4, 17, 32-33, 35, 38, 42, 44, 52, 57-59, 64, 68-72 are pending. Claims 32-33, 38, 42, 44, 52, 57 remain withdrawn. Claims 1, 4, 17, 32-33, 35, 38, 42, 44, 52, 59, 64 are currently amended. Claims 57-58 were previously presented.
Claims 1, 4, 17, 35, 58-59, 64, 68-72 are examined on the merits herein.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) and (f) [foreign application AU2020904452 filed 01December2020], and 35 U.S.C. 365(c) [national stage entry of PCT/AU2021/051425 filed 30November2021] is acknowledged. Claims 1, 4, 17, 35, 58-59, 64, 68-72 have an effective filing date of 01December2020.
Withdrawn Objections and/or Rejections
Objections and/or rejections made of record in the nonfinal office action dated 21January2026 that are not otherwise discussed herein are withdrawn. In particular:
RE ¶ 6: The Indefiniteness rejection regarding “preferably” language is withdrawn because all recitations of “preferably” appear to have been removed from the claims;
RE ¶ 7: The anticipation rejection over CN107043410 is withdrawn because claims 1 and 35 now require a particular mutation of the mtSSB (a deletion of at least the C-terminal 14 amino acids) and, as said of record, CN107043410 does not characterize the specific structure of the single base mutation;
RE ¶ 8: The anticipation rejection over CN102177778 is withdrawn because claims 1 and 35 now require a particular mutation of the mtSSB (a deletion of at least the C-terminal 14 amino acids) and, as said of record, CN102177778 does not characterize the specific structure of the single base mutation;
RE ¶ 9: The obviousness rejection over CN107043410 is withdrawn because claims 1 and 35 now require a particular mutation of the mtSSB (a deletion of at least the C-terminal 14 amino acids) and, as said of record, CN107043410 does not characterize the specific structure of the single base mutation;
RE ¶ 10: The obviousness rejection over CN107043410 and WO2017/083920 is withdrawn because claims 1 and 35 now require a particular mutation of the mtSSB (a deletion of at least the C-terminal 14 amino acids) and, as said of record, CN107043410 does not characterize the specific structure of the single base mutation;
and
RE ¶ 11: The obviousness rejection over CN102177778 and WO2017/083920 is withdrawn because claims 1 and 35 now require a particular mutation of the mtSSB (a deletion of at least the C-terminal 14 amino acids) and, as said of record, CN102177778 does not characterize the specific structure of the single base mutation.
Claim Rejections - 35 USC § 112 - Indefiniteness
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 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claim 1 (and, therefore, claims 4, 17, 58-59, 64, 68-71 which refer thereto without correcting the issue(s)) is/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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 says that the claimed grain has “a thickened aleurone … and a starchy endosperm”, but the claim does not provide a reference point by which this phenotype may be determined. For context, it was well-known before the filing of this application that aleurone thickness in cereal grains, for example, is impacted by at least environmental growth conditions. As an example, AUBERT et al.1 show that aleurone thickness varies between cultivars/varieties (i.e., genetic backgrounds) and also varies with environmental growth conditions (there, in the cereal barley). Therefore, these claims are indefinite. As a remedy, it is recommended that the claims be amended to something like “… thickened aleurone … and a starchy endosperm as compared to a control grain grown in the same environmental conditions ….”.
Claim 59 is 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As amended, claim 59 refers back to now-cancelled claim 2. Because claim 2 is cancelled, claim 59 is indefinite. For the purposes of examination, claim 59 was interpreted as referring back to claim 1.
Claim 71 is 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 which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
New claim 71 recites that the grain of claim 1 is rice “and the truncated mtSSB polypeptide is 192, 186, 185, 112, 80, 93, 134, 130, 183, or 182 amino acids in length.” This claim is indefinite for a couple reasons: (1) it is unclear what “is” means in this context (is it closed as in “consists of” or open as in “comprises”?). “Is” being open does not make sense in the context of a truncation, so it is believed that “is” should be amended to “consists of”. Also (2) reciting the length of a truncated polypeptide does not make sense without a reference full length sequence to compare the truncated version to. For completeness, Applicant should also please recite the truncated protein lengths in numerical order (i.e., “… [[is]] consists of 80, 93, 112, 130, 134, 182, 183, 185, 186, or 192
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, 17, 35, 58-59, 64, 68-72 are rejected under 35 U.S.C. 103 as being unpatentable over CN107043410 (published 15August2017 to WAN et al., an English-language machine translation of which is of record with the nonfinal 21January2026); WO2017/083920 (published 26May2017 to YU et al.; of record IDS 31May2023); LIU et al. (“Mutations in the DNA demethylase OsROS1 result in a thickened aleurone and improved nutritional value in rice grains” 2018 PNAS 115(44):11327-11332); and WU et al. (“The thick aleurone1 Gene Encodes a NOT1 Subunit of the CCR4-NOT Complex and Regulates Cell Patterning in Endosperm” 31July2020 Plant Physiol. 184(2):960-972).
CN107043410 teaches rice plants/parts (referred to therein as “N68”) comprising a mutation in the OsmtSSB gene and that, as a result, has grains with reduced starch as compared to wild type plants (referred to therein as “N22”).2 [relevant to “cereal” at claims 1, 35 and “rice” at claims 68, 72] By using complementation experiments, CN107043410 confirmed that the single base mutation3 in OsmtSSB causes reduced level or activity of the OsmtSSB gene and that the single base mutation causes the N68 mutant phenotype (including reduced starch in N68 seeds).4 In view of this specification, which confirms that ta1-1 mutant rice grains have decreased starch content5, it is believed that the N68 rice grain taught by CN107043410 also have a thickened aleurone than a wild type rice (e.g., N22) grain. [relevant to “thickened aleurone” at claim 1] Please note that SEQ ID NO: 1 of CN107043410 has 100% sequence identity to SEQ ID NO: 1 of this application6 and that SEQ ID NO: 2 of CN107043410 has 100% sequence identity to SEQ ID NO: 2 of this application7. Therefore, “OsmtSSB” of CN107043410 is the same as the Os05g43440/TA-1/OsmtSSB gene of this application (which encodes the amino acid sequence SEQ ID NO: 3). [relevant to SEQ ID NO: 3 at claim 17] CN107043410 says that OsmtSSB is a recessive gene.8
The teachings by CN107043410 about starch content are important and, therefore, worth emphasizing: CN107043410 teach that OsmtSSB is a starch synthesis gene and that a mutant OsmtSSB causes reduced starch content (see Figure 1) with a corresponding change in the “structure and properties” of the rice grain endosperm including “loose” arrangement of starch granules (i.e., a “chalky endosperm”) (see Figure 3 and accompanying discussion thereof) with a resulting expectation that the OsmtSSB mutation causes a “silky phenotype”:
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CN107043410 does not characterize the specific structure of the single base mutation.
WO2017/083920 teach rice plants/parts with a “ta2” OsROS1 mutant gene having reduced starch content (with increased lipid, protein, vitamin, and mineral content) and a thickened aleurone as compared to wild type.9 [relevant to “cereal” at claims 1, 35; “rice” at claims 68, 72; and relevant to “thickened aleurone” at claim 1] WO2017/083920 explain that ta2 mutant rice grain have a “looser packing of irregular-shaped starch granules” (i.e., “chalky endosperm”) as compared to wild type grain.10 WO2017/083920 also teach obtaining or producing flour, bran, wholemeal, malt, starch or oil therefrom.11 [relevant to the methods and products of claims 58, 59, 64] WO2017/083920 appears to be a patent publication of LIU et al.
LIU et al., like WO2017/083920, relates to rice plants/parts with a “ta2” OsROS1 mutant gene and explains that grains from osROS1 mutants have reduced starch content (with a desired increased lipid, protein, vitamin, and mineral content) as well as a thickened aleurone as compared to those of wild type plants.12 The OsROS1 gene encodes a DNA demethylase (i.e., like the thk1 of WU et al. discussed below, there is no evidence to suggest that the OsROS1 of WO2017/083920 and LIU et al. is an mtSSB gene). LIU et al. emphasizes that rice grain with increased lipid, protein, vitamin, and/or mineral content is desirable (see the “Significance” statement on page 11327, for example). There, increasing lipid/protein/vitamin/mineral nutrients corresponded to an increase in aleurone thickness (i.e., as the nutrient composition increased, so too did the size of the storage structure housing them). LIU et al. observed a thickening aleurone by 7 days after pollination (“DAP”) and say that the differences were “more pronounced from 9 DAP onward”.13 [relevant to “at day 20 after pollination” in claim 69]
Both WO2017/08392014 and LIU et al.15 provide evidence that, before the filing of this application, it was well-known in the art that cereal grains (and rice grains in particular) store starch in the starchy endosperm and store lipids/oil, proteins, vitamins, and minerals within the aleurone. Both WO2017/083920 and LIU et al. also evidence that, before the filing of this application, it would not have been surprising for there to be an inverse relationship between starch content and lipid, protein, vitamin, and/or mineral content (i.e., that a reduction in starch content within the starchy endosperm would correlate to an increase in lipid, protein, vitamin, and/or mineral content within the aleurone). Finally, both WO2017/083920 and LIU et al. provide evidence that, before the filing of this application, it would not have been surprising for decreased rice grain starch content (i.e., a “chalky endosperm”) to be correlated with an increased aleurone thickness (corresponding to an increased lipid, protein, vitamin, and/or mineral content which, again, are stored in the aleurone). To be clear, the Office is not suggesting a causal relationship of decreased cereal gran starch content always causes a shift toward, and accompanying increase in, cereal grain lipid, protein, vitamin, or mineral content or decreased cereal grain starch content always causes an increase in aleurone thickness—the Office is merely acknowledging a known correlation between these effects (i.e., that it would not be surprising to a person with ordinary skill in the art at the time this application was filed (a “POSA”) to find a decrease in cereal grain starch content together with an increase in cereal grain lipid/protein/vitamins/minerals content and/or a decrease in cereal grain starch content together with a thickened aleurone).
WU et al. teach the thick aleurone1 (“thk1”) gene on chromosome 1 in maize is Zm00001d027278 and encodes a NOT1 deadenylase subunit of the CCR4-NOT complex.16 WU et al. also teach that maize plants homozygously comprising a loss-of-function thk1 mutation have thickened aleurone as compared to a control maize plant’s single/one layer of aleurone cells (Figure 1E appears to show that mutants have multiple aleurone cells at all locations and even five layers in some places).17 A mutation taught by WU et al. includes introducing a premature stop codon in exon 3 of thk1 (the full length of which has 51 exons) which, therefore, lacks at least “the C-terminal 14 amino acids” of the encoded thk1 protein.18 [relevant to “cereal” at claims 1, 35; relevant to “lacks at least the C-terminal 14 amino acids” at claims 1, 35; and “at least two … layers of cells” at claim 70] Histological analysis to determine aleurone thickness was done using kernels which were harvested 19 days after pollination (“DAP”)19, meaning the thickened aleurone observed by WU et al. occurred by “day 20 after pollination”. [relevant to claim 69] Please note that there is no evidence to suggest that the thick aleurone1 gene taught by WU et al. is also an mtSSB gene. To ensure clarity of the record, WU et al. is primarily cited to show that the truncation of “at least the C-terminal 14 amino acids” would have been an obvious means of obtaining a null, loss-of-function mutant.
As said of record,20 the Office maintains that it would have been obvious to a POSA in view of CN107043410 to generate a null/loss-of-function mutation of OsmtSSB because it would have been at least “obvious to try” (MPEP § 2143(I)(E)) and with the motivation of achieving the low-starch rice grain that was already achieved by (an unspecified) single point mutation. WU et al. is added here to, amongst other things, show that the structural limitation of “lacks at least the C-terminal 14 amino acids” is not enough to make these claims nonobvious: in view of at least WU et al., it would have been obvious to a POSA to generate a null/loss-of-function OsmtSSB mutant by introducing a premature stop codon and truncating at least the C-terminal 14 amino acids of the encoded protein. WO2017/083920 and LIU et al. are relevant at least because they add depth to motivation and provide context for what a POSA would have reasonably expected of OsmtSSB null mutants: in view of WO2017/083920 and LIU et al., it is believed that a POSA would have reasonably expected OsmtSSB null, loss-of-function mutant grains to have low-starch (“chalky”) endosperms (consistent with CN107043410) and an increased aleurone thickness. In view of WO2017/083920 and LIU et al., it is believed that one such POSA would have also reasonably expected the increased aleurone thickness may be accompanied by an increase in lipid, protein, vitamin, and/or mineral content therein. As emphasized by LIU et al., it is believed that the potential for a desirable nutrient profile (at least lower starch and possibly an increase in lipids/proteins/vitamins/minerals) would have motivated one such POSA to select OsmtSSB from CN107043410 and to generate null, loss-of-function mutations thereof (such as by truncating off the “at least C-terminal 14 amino acids” from the encoded protein). (MPEP § 2143(I)(E)) [claims 1, 4, 17, 68, 71] Given the teaching by CN107043410 that OsmtSSB is recessive, it would have been obvious to a POSA that the rice plant/part homozygously comprise a null mutant thereof in order to achieve a phenotypic effect in grain. [claim 35, 72] Processing mutant OsmtSSB grain to obtain flour, for example, would have been obvious and commercially desirable in view of at least WO2017/083920. [claims 58-59, 64] Finally, the mutant rice grain having a thickened aleurone of “at least two … layers of cells” [claim 70] by at least “day 20 after pollination” [claim 69] would have been reasonably expected in view of at least WO2017/083920, LIU et al., and WU et al. 2020.
Claim Rejections - 35 USC § 112 – Written Description and Enablement (How to Use)
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.
The following Written Description and Enablement rejections are based on the same issues (breadth of claimed plants and mtSSB mutant alleles), so they are purposefully presented together here. The claims reciting some sort of functional effect (e.g., starchy endosperm or thick aleurone) are rejected for lack of Written Description whereas the claim(s) which do not recite a functional effect are rejected for lack of Enablement (How to Use).
Written Description:
Claims 1, 4, 17 REMAIN rejected and newly presented claims 68-71 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.
These claims (as elected) generally encompass obtaining at least a thickened aleurone within a cereal grain (or rice grain for claims 68 and 71) via the homozygous presence of any mitochondrial single-stranded DNA binding (mtSSB) gene (or OsmtSSB comprising SEQ ID NO: 3 for claim 17) from which at least the C-terminal 14 amino acids are truncated (specific truncations being recited in claim 71).
This specification only describes one mtSSB gene (that being Os05g43440 comprising SEQ ID NO: 1 or 2 and encoding SEQ ID NO: 3). The specification also only describes achieving a thickened aleurone in one cereal grain (rice) and in one way (a rice plant/part homozygously comprising a premature stop codon within the mtSSB Os05g43440 gene, causing the encoded protein to have a loss-of-function—the two approaches discussed in the specification are to introduce a premature stop codon via a G2126A point mutation21 or via a null mutation generally22.
As mentioned within the obviousness rejection hereinabove, there are several examples within the prior art of mutating “thickened aleurone” genes within cereal grains and achieving a thickened aleurone (including gross truncations of such genes to achieve a null, loss-of-function mutation, such as by WU et al.23), but the Office does not see an example, other than this specification, of using a mutant mtSSB gene to achieve a thicker aleurone (all should note that the OsROS1 “thickened aleurone” gene of WO2017/083920 and LIU et al.24 is a DNA demethylase and the “thickened aleurone” gene of WU et al. is an RNA deadenylase, i.e., not mtSSB genes). Prior art reference CN107043410 is commensurate in scope with this specification in that it only teaches “OsmtSSB” which is Os05g43440 encoding SEQ ID NO: 3. Like this specification, CN107043410 is specific for rice grain and says that the OsmtSSB/Os05g43440 gene is recessive (meaning a mutation thereof must be homozygously present25 to cause reduced starch or thickened aleurone).
No prior art references have been identified by the Office which may supplement the deficiencies of this specification.
Absent evidence to the contrary, it is believed that a skilled artisan at the time this application was filed would not have reasonably recognized Applicant as being in possession of the full metes and bounds of these claims. Namely, the skilled artisan would not have reasonably believed Applicant to be in possession of achieving a thickened aleurone in any cereal grain, using any mtSSB gene truncated in any manner that includes the C-terminal 14 amino acids of the encoded protein, when homozygously present. It would be remedial of this rejection to amend these claims so that they specify that the plants/parts are rice plants/parts; to specify that the wild type mtSSB gene comprises SEQ ID NOs: 1 or 2 (or encodes SEQ ID NO: 3); and that the genetic variation is a null, loss-of-function G2126A mutation (numbered according to SEQ ID NO: 1).
Please note that within the discussion of allowable subject matter herein below, the Office suggests specifying the gene being mutated (Os05g43440 comprising SEQ ID NOs: 1 or 2 and that encodes SEQ ID NO: 3) as well as the specific mutation being introduced (G2126A, numbered according to SEQ ID NO: 1). Those recommendations are being made because of the prior art rejections, Enablement (How to Use) rejection, and in view of the elected subject matter.
Response to Applicant’s Remarks 21May2026:
Applicant asserts that because the specification describes “homologues of the rice TA1 gene in other cereals”, that the specification sufficiently describes the full metes and bounds of what is being claimed. (Remarks at page 24)
This is not persuasive because even if cereal homologues of Os05g43440 are identified in the specification, and assuming for the sake of brevity that they are truly functional homologues, these claims are not limited to Os05g43440 and specific homologues thereof (these claims recite any mtSSB gene). Furthermore, this argument does not address the fact that Os05g43440 appears to require a loss-of-function mutation to achieve the claimed phenotypes (when homozygously present).
Enablement:
Claim 35 REMAINS rejected and newly presented claim 72 is 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 a rice plant/part homozygously comprising null Os05g43440/OsmtSSB alleles or homozygously comprising the G2126A mutation within the Os05g43440/OsmtSSB alleles sequence SEQ ID NO: 1 or 2, does not reasonably provide enablement for how to use (1) any cereal plant/part that homozygously comprises (3) any truncated variant (2) of any mtSSB gene or its encoded protein. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, how to use the invention commensurate in scope with these claims.
All of the claims filed 21May2026 now recite that the mutant allele is homozygously present (i.e., including claims 35 and 72). The other issues (i.e., breadth of cereals, breadth of mtSSB genes, and mutations) are not remedied by the claim amendments.
The factors used (and weighed) to determine whether a specification satisfies the enablement requirement (and, thus, whether any necessary experimentation would be ‘undue’) include, but are not limited to, the following: (A) the breadth of the claims; (B) the nature of the invention; (C) the state of the prior art; (D) the level of one of ordinary skill; (E) the level of predictability in the art (“if one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art”)26; (F) the amount of direction provided by the specification; (G) the existence of working or prophetic examples; and (H) the quantity of experimentation needed to make or use the invention based on the content of the specification read in view of the prior art (including whether “one would expect to be able to extrapolate [the example(s)] across the entire scope of the claims”27).28
Regarding (A) the breadth of the claims:
The rejected claim recites (1) any cereal plant/part that homozygously comprises (3) any truncated variant (2) of any mtSSB gene or its encoded protein. Materially, the rejected claim does not recite a particular functional/phenotypic effect caused by the reduced level/activity of the cereal plant/part’s one mtSSB allele.29
The claim encompasses a broad scope of subject matter.
Regarding (B) the nature of the invention, (F) the amount of direction provided by the specification; and (G) the existence of working or prophetic examples:
This specification explains that (RE 1→) rice plants/parts that homozygously comprise a (RE 3→) G2126A mutation30 or a null mutation31 within the (RE 2→) Os05g43440 gene comprising SEQ ID NO: 1 or 2 (that encodes SEQ ID NO: 3) has a grain with starchy endosperm and/or thickened aleurone.32
The amount of direction provided by the specification (including examples) is very narrow compared to the full breadth of the claims.
Regarding (C) the state of the prior art; (D) the level of one of ordinary skill; and (E) the level of predictability in the art:
While mutating the (RE 1→) rice (RE 2→) Os05g43440 gene or “TA” gene were known to the prior art, as well as their associated impact on at least starch biosynthesis; those teachings are limited to (RE 1→) rice, and (RE 2→) OsmtSSB/Os05g43440. Further, the (RE 3→) specific nature of the mtSSB mutation (i.e., including OsmtSSB/Os05g43440 mutation) which will have a useful, functional impact is not known from the prior art. As discussed throughout this action, there are several examples within the prior art of mutating “thickened aleurone” genes within cereal grains and achieving a thickened aleurone (including gross truncations of such genes to achieve a null, loss-of-function mutation, such as by WU et al.33), but the Office does not see an example, other than this specification, of using a mutant mtSSB gene to achieve a thicker aleurone (all should note that the OsROS1 “thickened aleurone” gene of WO2017/083920 and LIU et al.34 is a DNA demethylase and the “thickened aleurone” gene of WU et al. is an RNA deadenylase, i.e., not mtSSB genes). Prior art reference CN107043410 is commensurate in scope with this specification in that it only teaches “OsmtSSB” which is Os05g43440 encoding SEQ ID NO: 3. Like this specification, CN107043410 is specific for rice grain and says that the OsmtSSB/Os05g43440 gene is recessive (meaning a mutation thereof must be homozygously present35 to cause reduced starch or thickened aleurone).
Furthermore, the inventors’/Applicant’s own post-filing publication LI et al.36 states that there are mutations within (RE 1→) rice’s (RE 2→) OsmtSSB1/Os05g43440 that do not have an impact on at least aleurone thickness (←RE 3). Therefore, there is credible evidence to suggest that one may not simply truncate the specific rice mtSSB gene Os05g43440/OsmtSSB and reasonably expect a specific and substantial phenotype change (let alone any truncation of any cereal metSSB gene and reasonably expect a specific and substantial phenotype change). Achieving at least a thicker aleurone appears to require a loss-of-function mutation within Os05g43440/OsmtSSB (which may be specified in the claims by reciting the (elected) G2126A mutation, numbered according to SEQ ID NO: 1). For consistency, please note that the Office is purposefully not suggesting that these claims simply say a “null mutation” or a “loss-of-function mutation” because, further to the obviousness rejection hereinabove, those generic recitations are not believed to be sufficient for overcoming the prior art (= it is recommended that particular nucleotide/residue mutations be recited such as the elected G2126A substitution which are believed to be nonobvious).
The teachings of the prior art and, in fact, the post-filing art do not supplement the deficiencies of the specification.
Regarding (H) the quantity of experimentation needed to make or use the invention based on the content of the specification read in view of the prior art:
Neither the specification nor the art explain how to use, in a specific and substantial way, the full breadth of what is being claimed.
The standard of an enabling disclosure is not the ability to make and test if the invention works, but rather, the ability (in view of the specification and prior art) to make and use the invention with a reasonable expectation of success. A patent is granted for a completed invention, not the general suggestion of an idea.37 The instant specification is not enabling because one cannot follow the guidance presented therein, or within the art at the time of filing, and practice the claimed method without first making their own substantial, inventive contribution (i.e., conception). Here, the amount of experimentation required so that a skilled artisan can use the claimed product goes beyond what is considered ‘routine' within the art and constitutes undue further experimentation.
Because the claims encompass a breadth of (RE 1) plant types, (RE 2) genes, and (RE 3) modulation types (e.g., any truncation, at any location); and because the specification and the prior art only teach mutating (the nature of which is unclear) the (RE 2) OsmtSSB/Os05g43440 gene homozygously within a (RE 1) rice plant/part to confer a phenotype change in, for example, starch biosynthesis or aleurone thickness; a skilled artisan would not expect to be able to extrapolate the limited teachings in the specification and prior art across the entire scope of the claims.
In the context of the subject technology, and as evidenced by Inventors’/Applicant’s own post-filing publication LI et al.38, “it is not reasonably predictable from the disclosure of one species, what other species will work.”39 A skilled artisan could not follow the guidance presented within the specification or prior art to use the claimed product (in a specific and substantial way) without first engaging in undue trial and error experimentation such as by having to first select a cereal plant such as wheat, rye, oat, barley, or even maize and then identify the one or more mtSSB genes therein. A skilled artisan would then need to truncate the one or more mtSSB genes (such as via mutagenesis, but RNA silencing techniques may also be used) and then conduct screening analysis to see whether any of the truncations have a useful impact on the cereal’s phenotype and, assuming a candidate is identified (let’s say a particular mutation), then the artisan would need to conduct experiments (such as complementation assays) to confirm that it is, in fact, the candidate (e.g., the truncation mutation) causing the observed phenotype change (and not, for example, the modulation of a different gene and/or environmental factors40). As a skilled artisan would understand, if any of these exemplary experimental steps were to fail; the skilled artisan would have to start over or engage in a redesign effort until a useful product is obtained. This amount of experimentation is not merely quantitative and is certainly not routine41—in fact, these hypothetical experiments are the type that often result in a substantial inventive contribution (i.e., conception).
For at least these reasons, the specification does not enable the full scope of the claimed subject matter.
In MAINTAINING this rejection, at least two points are worth emphasizing: (1) the Office cannot find evidence of a “thick aleurone” gene that is also an mtSSB gene other than OsmtSSB/Os05g43440 in any cereal plant that, when function is lost, has a specific and substantial use (such as decreasing starch content and increasing aleurone thickness). The record reflects several “thick aleurone” genes known to the prior art, but the Office cannot find one in the prior art that is also an mtSSB gene (note that the OsROS1 “thickened aleurone” gene of WO2017/083920 and LIU et al.42 is a DNA demethylase and the “thickened aleurone” gene of WU et al. is an RNA deadenylase). Furthermore (2), increasing aleurone thickness appears to require a loss-of-function of the OsmtSSB/Os05g43440 gene. While other deficiencies are raised in this rejection (e.g., breadth of plants claimed), these two points are alone sufficient to maintain this rejection. The specification and prior art do not enable a skilled artisan to use the full scope of these claims without undue trial and error experimentation. It would be remedial of this rejection to amend the claim so that it specifies that the plants/parts are (RE 1→) rice plants/parts; to specify that (RE 2→) the wild type mtSSB gene comprises SEQ ID NOs: 1 or 2 (or encodes SEQ ID NO: 3); to specify that the genetic variation is (RE 3→) the loss-of-function G2126A mutation (elected, numbered with respect to SEQ ID NO: 1). Please note that this recommendation is intended to be consistent with the discussion of allowable subject matter herein below. Please also note that this particular suggestion is being made with an eye toward the prior art rejections (← hence, specifying a null mutation is not being recommended), the Written Description rejection above, as well as the elected subject matter (← also why specifying a null mutation is not being recommended).
Response to Applicant’s Remarks 21May2026:
Applicant asserts that this enablement rejection is not in compliance with the evidentiary standards of the MPEP at least because “no evidence has been presented which contradicts the applicability of the recited homozygous genetic variations in cereal plants/parts other than rice”. (Remarks at page 25)
This is not persuasive in view of at least inventors’/Applicant’s own post-filing publication LI et al.43 (which was discussed of record and hereinabove). These claims continue to recite any truncated mtSSB gene and LI et al. evidence, amongst other things, that only particular mutations within the specific rice mtSSB gene OsmtSSB/Os05g43440 are useful for modulating grain phenotypes. It remains unreasonable to suggest that the narrow example within this specification can be extrapolated out to any truncation mutation of any mtSSB gene within any cereal grain (as evidenced by inventors’/Applicant’s own post-filing publication LI et al.44).
Conclusion
THIS ACTION IS MADE FINAL. 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.
The following is a statement of reasons for the indication of allowable subject matter: this application appears to be the first to describe the G2126A substitution mutation within the Os05g43440/TA-1/OSmtSSB sequence SEQ ID NOs: 1-2 and it causing, when homozygously present within a rice plant/part, grain to have an at least thickened aleurone (as compared to a control rice plant/part grown in the same environmental conditions). Therefore, and based on the information provided at Examples 1-9, 12 of this specification (where Applicant explains that the G2126A nucleotide mutation causes three splice variants referred to as “I”, “II”, and “III”), it is recommended that these claims be amended so that they are directed toward rice plant(s)/part(s) that are homozygous for the G2126A genetic variation (numbered with respect to SEQ ID NO: 1) and then, via dependent claims, the claims may further specify the three splice variants including their accompanying sequences (which, per the specification, are caused by the G2126A mutation). To be clear, the Office is suggesting that the broadest claims focus on the G2126A mutation (as in SEQ ID NO: 4) and then narrower, dependent claims capture the subject matter of claims 5-10 and 12-14 (splice variants). The Office is acknowledging that currently non-elected subject matter (splice variant species) would be considered for rejoinder in advance of allowance. Please do not forget to also limit the claims to rice and to specify that the G2126A mutation is homozygously present (both of which appear to be required per the rejections under 35 U.S.C. § 112(a)). To be clear, the Office is not suggesting that these claims specify a null mutation of Os05g43440 (SEQ ID NOs: 1 or 2) be homozygously present because null mutations is believed to be obvious in view of the prior art and, in any event, is not elected subject matter. As always, Applicant’s representative is welcomed to propose claim amendments to the Office (e.g., via email) in advance of filing a reply to this action to ensure the Office and Applicant are aligned on patentable claims.
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.
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/REBECCA STEPHENS/Examiner, Art Unit 1663
/MATTHEW R KEOGH/Primary Examiner, Art Unit 1663
1 AUBERT et al. “Differences in hydrolytic enzyme activity accompany natural variation in mature aleurone morphology in barley (Hordeum vulgare L.)” 2018 Scientific Reports 8(11025): 14 total pages (DOI:10.1038/s41598-018-29068-4).
2 CN107043410 at pages 4, 5, 8 of the English-language translation.
3 CN107043410 at page 8 of the English-language translation.
4 CN107043410 at page 11 of the English-language translation.
5 See the specification at page 96, lines 5-9 as well as Table 3 on page 94.
6 See Result 3 of the ABSS sequence search results file entitled “20260109_103533_us-18-255-184-1.rng”.
7 See Result 1 of the ABSS sequence search results file entitled “20260109_103533_us-18-255-184-2.rng”.
8 CN107043410 at the bottom of page 5 of the English-language translation.
9 WO2017/083920 at Example 5 on page 80 and Example 12 on page 91.
10 WO2017/083920 at lines 24-28 on page 74.
11 WO2017/083920 at claims 41 and 46-48 on pages 106-107).
12 LIU et al. at Abstract as well as pages 11327-11328.
13 LIU et al. at the right column on page 11328.
14 See WO2017/083920 at pages 1-2.
15 See LIU et al. at Abstract and page 11327.
16 WU et al. at Abstract, lower right column on page 961 through page 963, lower right column on page 967 through 968.
17 WU et al. at pages 962-963 including figure 1.
18 WU et al. at the right column of page 962.Please note that at the left column on page 963, Zm00001d027278 is described as having 51 exons and encoding an amino acid sequence that is 2,454 residues long.
19 WU et al. at the right column of page 969.
20 See lines 13-17 on page 10 of the Nonfinal 21January2026.
21 See Examples 1-9 of the specification.
22 See Example 13 of the specification.
23 WU et al. (“The thick aleurone1 Gene Encodes a NOT1 Subunit of the CCR4-NOT Complex and Regulates Cell Patterning in Endosperm” 31July2020 Plant Physiol. 184(2):960-972).
24 LIU et al. (“Mutations in the DNA demethylase OsROS1 result in a thickened aleurone and improved nutritional value in rice grains” 2018 PNAS 115(44):11327-11332).
25 CN107043410 at page 5 of the English language translation.
26 MPEP § 2164.03.
27 MPEP § 2164.02(I).
28 MPEP § 2164.01(a) (citing In re Wands 858 F.2d 731 at 737; 8 USPQ2d 1400 at 1404 (Fed. Circ. 1988)).
29 Please note that if this claim did recite a functional/phenotypic effect, it would be rejected for a lack of Written Description.
30 See Examples 1-9 of the specification.
31 See Example 13 of the specification.
32 See Examples 1-9 of the specification.
33 WU et al. (“The thick aleurone1 Gene Encodes a NOT1 Subunit of the CCR4-NOT Complex and Regulates Cell Patterning in Endosperm” 31July2020 Plant Physiol. 184(2):960-972).
34 LIU et al. (“Mutations in the DNA demethylase OsROS1 result in a thickened aleurone and improved nutritional value in rice grains” 2018 PNAS 115(44):11327-11332).
35 CN107043410 at page 5 of the English language translation.
36 LI et al. “Defective mitochondrial function by mutation in THICK ALEURONE 1 encoding a mitochondrion-targeted single-stranded DNA-binding protein leads to increased aleurone cell layers and improved nutrition in rice” 2021 Molecular Plant 14:1343-1361; of record IDS 31May2023.
37 MPEP 2164.03 citing Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
38 LI et al. “Defective mitochondrial function by mutation in THICK ALEURONE 1 encoding a mitochondrion-targeted single-stranded DNA-binding protein leads to increased aleurone cell layers and improved nutrition in rice” 2021 Molecular Plant 14:1343-1361; of record IDS 31May2023.
39 MPEP § 2164.03.
40 Recall that AUBERT et al. (“Differences in hydrolytic enzyme activity accompany natural variation in mature aleurone morphology in barley (Hordeum vulgare L.)” 2018 Scientific Reports 8(11025): 14 total pages (DOI:10.1038/s41598-018-29068-4)) show that at least aleurone thickness changes with genetic background and environmental growth conditions (there, in the context of barley).
41 See MPEP § 2164.06.
42 LIU et al. (“Mutations in the DNA demethylase OsROS1 result in a thickened aleurone and improved nutritional value in rice grains” 2018 PNAS 115(44):11327-11332).
43 LI et al. “Defective mitochondrial function by mutation in THICK ALEURONE 1 encoding a mitochondrion-targeted single-stranded DNA-binding protein leads to increased aleurone cell layers and improved nutrition in rice” 2021 Molecular Plant 14:1343-1361; of record IDS 31May2023.
44 LI et al. “Defective mitochondrial function by mutation in THICK ALEURONE 1 encoding a mitochondrion-targeted single-stranded DNA-binding protein leads to increased aleurone cell layers and improved nutrition in rice” 2021 Molecular Plant 14:1343-1361; of record IDS 31May2023.
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