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
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the Groups set forth in the Restriction/Unity of Invention requirement; i.e. 28, 32-33, 38, 40-42, 44, 52, 57, 67) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group of invention, there being no allowable generic or linking claim.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
No Claims were filed with Applicant’s Restriction/Unity election filed 08December2025 (as supplemented by the reply filed 09January2025). Therefore, the claims filed 08July2025 (= those subject to Restriction/Unity of Invention requirement) remain the last-filed and are considered here. Claims 1,2, 4, 7, 17, 28, 32-33, 35, 38, 40-42, 44, 52, 57-59, 64, 67 are pending. Claims 3, 5-6, 8-16, 18-27, 29-31, 34, 36-37, 39, 43, 45-51, 53-56, 60-63, 65-66 are/were canceled. Claims 2, 4, 7, 17, 28, 32-33, , 35, 38, 40-42, 44, 52, 57-59, 64, 67 are all currently amended with only claim 1 being original. Following the restriction requirement mailed 08October2025 and Applicant’s election dated 08December2025 (as supplemented by the reply filed 09January2025), claims 28, 32-33, 38, 40-42, 44, 52, 57, 67 are withdrawn as being directed toward a non-elected group and/or species (rejoinder currently being inappropriate).
Claims 1, 2, 4, 7, 17, 35, 58-59, 64 are examined on the merits herein.
Because these claims are voluminous and the claims within the elected Group I contain many non-elected species, please see the 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).
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, 2, 4, 7, 17, 35, 58-59, 64 have an effective filing date of 01December2020.
Claims Summary
For clarity of the record, below is a summary of the Examined Claims (as elected). Mark-ups are removed for readability and line breaks are (largely) maintained. Non-elected species shown by ellipsis “…”.
1. (Original) Cereal grain comprising an aleurone, an embryo, a starchy endosperm and a reduced level and/or activity of at least one mitochondrial polypeptide relative to a corresponding wild-type cereal grain, wherein the mitochondrial polypeptide which
is reduced in its level and/or activity is at least one of a mitochondrial single-stranded DNA binding (mtSSB) polypeptide ….
2. (Currently Amended) The grain of claim 1 which comprises a
genetic variation which reduces the level and/or activity of the at least one mitochondrial polypeptide in the grain relative to the corresponding wild-type cereal grain, preferably wherein the genetic variation comprises
(i) a mutation in an endogenous gene which encodes the mitochondrial polypeptide, whereby the mutation results in
the reduced level and/or activity of the mitochondrial
polypeptide, or …
preferably wherein the genetic variation is an introduced
genetic variation and/or wherein the grain is homozygous for the genetic variation.
4. (Currently Amended) The grain of claim 2, wherein the
genetic variation comprises: …
(b) a deletion or an insertion within the endogenous gene which encodes the mitochondrial polypeptide, preferably a
deletion which was introduced by mutagenesis of a
progenitor cereal plant cell, ….
7. (Currently Amended) The grain of claim l which has a thickened aleurone, preferably wherein
the grain has a thickened aleurone at day 20 after pollination, more preferably wherein the thickened aleurone comprises at
least two, at least three, at least four or at least five layers of cells, about 3, about 4, about 5 or about 6 layers of cells,
or 2-8, 2-7, 2-6, 2-5 or 3-5 layers of cells, or a number of
cell layers between 2 and 8, 2 and 7, or 2 and 6, preferably
wherein the grain is further characterised by one or more of:
(a) the grain comprises, when compared to a corresponding wild- type cereal grain, one or more or all of the following,each on a weight basis, …
iii) a higher fiber content …
(c) the grain comprises, when compared to a corresponding wild- type cereal grain, a higher number of aleurone cells, … and
(l) the grain is rice grain …, preferably rice grain, more preferably brown rice grain or black rice grain.
17. (Currently Amended) The grain of claim 1, wherein:
(a) the corresponding wild-type grain comprises a mtSSB
polypeptide which comprises an amino acid sequence as
provided in any one of SEQ ID NOs: 3 …, or an
amino acid sequence which is at least 75% identical to any
one or more of SEQ ID NOs: 3 …, preferably wherein
the mtSSB polypeptide is a mtSSB-la polypeptide, more
preferably wherein the corresponding wild-type grain
comprises mtSSB-la polypeptide which comprises an amino
acid sequence as provided in any one of SEQ ID NOs: 3 …, or
an amino acid sequence which is at least 75%
identical to any one or more of SEQ ID NOs: 3 …,
even more preferably wherein the corresponding wild-type
grain comprises a mtSSB-la polypeptide which comprises an
amino acid sequence as provided in SEQ ID NO: 3, or an
amino acid sequence which is at least 75% identical to SEQ
ID NO: 3; ….
35. (Currently Amended) A cereal plant cell, seed or tissue
therefrom, the cell, seed or tissue therefrom comprising a
reduced level and/or activity of at least one mitochondrial polypeptide relative to a corresponding wild-type cereal plant cell, wherein the mitochondrial polypeptide which is reduced in its level and/or activity is at least one of a mitochondrial
single-stranded DNA binding (mtSSB) polypeptide,…
preferably wherein the cell, seed or tissue therefrom is or comprises an endosperm, testa, aleurone or embryo cell, more preferably wherein the cell,seed or tissue therefrom is an aleurone cell.
58. (Currently Amended) A method of producing processed grain, or flour, bran, wholemeal, malt, starch or oil obtained from grain,
the method comprising:
a) obtaining the grain of claim 1, and
b) processing the grain to produce the processed grain, flour,
bran, wholemeal, malt, starch or oil.
59. (Currently Amended) A product produced from the grain of claim 2, or from a part of said grain comprising the genetic variation, preferably wherein the product comprises the genetic variation
and the thickened aleurone, preferably wherein the part is
cooked, boiled, parboiled, roasted, baked, polished, cracked,
puffed, milled or flaked grain, or bran, more preferably wherein
the product is a food ingredient, beverage ingredient, food
product or beverage product, even more preferably wherein
i) the food ingredient or beverage ingredient is selected from
the group consisting of roasted grain, polished grain,
cracked grain, puffed grain, milled grain, flaked grain,
wholemeal, flour, bran, starch, malt and oil,
ii) the food product is selected from the group consisting of: processed grain, cooked grain, boiled grain, porridge,
leavened or unleavened breads, pasta, noodles, animal
fodder, breakfast cereals, snack foods, cakes, pastries and
foods containing a flour-based sauce, or
iii) the beverage product is a tea, a packaged beverage or a beverage comprising ethanol.
64. (Currently Amended) A method of preparing a food or beverage ingredient the method comprising processing the grain
of claim 1, or bran, flour, wholemeal, malt, starch or oil from the grain, to produce the food or beverage ingredient, preferably wherein processing the grain is by cooking, boiling, roasting or flaking the grain, or mixing the grain or bran, flour, wholemeal, malt, starch or oil from the grain, with another food or beverage ingredient.
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.
Claims 2, 4, 7, 17, 35, 59, 64 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.
These claims all recite that certain elements/features are “preferable” (recited as “preferably” throughout the claims). Due to the recitation of “preferable” language, the metes and bounds of these claims are indefinite—it is not clear whether those “preferable” elements/features are in fact required for the claimed subject matter or not. Furthermore, what one person considers “preferable” is subjective (it may not be “preferable” to another person, especially in all contexts). For the sake of examination herein, “preferably” phrases are considered optional (i.e., non-limiting).
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, 7, 17, 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN107043410 (published 15August2017 to WAN et al., an English-language machine translation of which is attached hereto).
To ensure a clear record, please note the summary of the claims provided above and the indefiniteness rejection of “preferable” language above (as said there, “preferably” phrases are non-limiting).
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”).1 By using complementation experiments, CN107043410 confirmed that the single base mutation2 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).3 [claims 1, 2, 35] In view of this specification, which confirms that ta1-1 mutant rice grains have decreased starch content4, 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. [claim 7] Please note that SEQ ID NO: 1 of CN107043410 has 100% sequence identity to SEQ ID NO: 1 of this application5 and that SEQ ID NO: 2 of CN107043410 has 100% sequence identity to SEQ ID NO: 2 of this application6. 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). [claim 17]
CN107043410 does not characterize the specific structure of the single base mutation, therefore claim 4 is not rejected here (see also the Office’s discussion of allowable subject matter at the “Conclusion” section of this action).
Claims 1, 2, 7, 17, 35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN102177778 (published 14September2011 to LIU et al., an English-language machine translation of which is attached hereto).
To ensure a clear record, please note the summary of the claims provided above and the indefiniteness rejection of “preferable” language above (as said there, “preferably” phrases are non-limiting).
CN102177778 teaches rice plants/parts comprising a “ta-1 or “ta-2” mutation that, as a result, has grains, or is a grain, with a thickened aleurone layer as compared to wild type.7 [claims 1, 2, 7, 35] As said of record and again herein above, CN102177778 is an inventor/Applicant-publication and absent evidence to the contrary from Applicant (e.g., declaration practice); the Office maintains the position that the “TA-1” gene of CN102177778 is the same as the Os05g43440/TA-1/OsmtSSB gene of this application. [claim 17]
CN102177778 does not characterize the specific structure of the “ta-1” or “ta-2” mutations, therefore claim 4 is not rejected here (see also the Office’s discussion of allowable subject matter at the “Conclusion” section of this action).
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.
Claim 4 is 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 attached hereto) as applied to claim 2.
To ensure a clear record, please note the summary of the claims provided above and the indefiniteness rejection of “preferable” language above (as said there, “preferably” phrases are non-limiting).
The teachings of CN107043410 are as stated above.
CN107043410 does not characterize the specific structure of the single base mutation (hence, claim 4 is not believed to be anticipated by CN107043410), but absent evidence to the contrary, it is believed that a person with ordinary skill in the art (“POSA”) would have found it obvious in view of the teachings by CN107043410 to generate a null OsmtSSB allele by, for example, introducing a truncation/deletion mutation (e.g., introducing a premature stop codon) into the OsmtSSB gene sequence taught by CN107043410 [claim 4]. Given the teachings by CN107043410 (such as the complementation experiments) and the general knowledge in the art, the subject matter of claim 4 (as elected) would have been obvious to a POSA at least because introducing a mutation (such as a deletion or insertion mutation) so as to generate a null OsmtSSB allele (such as one having a premature stop codon) would have been “obvious to try” (MPEP § 2143(I)(E)).
Claims 58-59, 64 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 attached hereto) as applied to claims 1, 2, 7, 17, 35 above further in view of WO2017/083920 (published 26May2017 to YU et al.; of record IDS 31May2023).
The teachings of CN107043410 are as stated above.
CN107043410 does not teach producing or obtaining (commercial) products from rice grain (such as flower, bran, wholemeal, malt, starch, or oil).
WO2017/083920 teach rice plants/parts with a “ta2” mutant gene having reduced starch and a thickened aleurone as compared to wild type.8 WO2017/083920 also teach obtaining or producing flour, bran, wholemeal, malt, starch or oil therefrom.9
Based on at least WO2017/083920, it would have been obvious to a person with ordinary skill in the art (“POSA”) to obtain or produce producing flour, bran, wholemeal, malt, starch or oil from the mutant rice plants/parts of CN107043410 [claims 58-59, 64] because it would have amounted to no more than
- the “use of a known technique [WO2017/083920] to improve similar products [CN107043410] in the same way” (MPEP § 2143(I)(C)) and/or
- the “applying a known technique [WO2017/083920] to a known product [CN107043410] ready for improvement to yield predictable results” (MPEP § 2143(I)(D)).
Claims 58-59, 64 are rejected under 35 U.S.C. 103 as being unpatentable over CN102177778 (published 14September2011 to LIU et al., an English-language machine translation of which is attached hereto) as applied to claims 1, 2, 7, 17, 35 above further in view of WO2017/083920 (published 26May2017 to YU et al.; of record IDS 31May2023).
The teachings of CN102177778 are as stated above.
CN102177778 does not teach producing or obtaining (commercial) products from rice grain (such as flower, bran, wholemeal, malt, starch, or oil).
WO2017/083920 teach rice plants/parts with a “ta2” mutant gene having reduced starch and a thickened aleurone as compared to wild type.10 WO2017/083920 also teach obtaining or producing flour, bran, wholemeal, malt, starch or oil therefrom.11
Based on at least WO2017/083920, it would have been obvious to a person with ordinary skill in the art (“POSA”) to obtain or produce producing flour, bran, wholemeal, malt, starch or oil from the mutant rice plants/parts of CN102177778 [claims 58-59, 64] because it would have amounted to no more than
- the “use of a known technique [WO2017/083920] to improve similar products [CN102177778] in the same way” (MPEP § 2143(I)(C)) and/or
- the “applying a known technique [WO2017/083920] to a known product [CN102177778] ready for improvement to yield predictable results” (MPEP § 2143(I)(D)).
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 encompassed heterozygous 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, 2, 4, 7, 17 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 an at least starchy endosperm or thickened aleurone within any cereal grain comprising any mutation (heterozygously or homozygously present) within any gene encoding a mitochondrial single-stranded DNA binding (mtSSB) polypeptide and/or “thick aleurone” (“ta”) gene.
This specification only describes obtaining a starchy endosperm and/or thickened aleurone via rice plants/parts that homozygously comprise a G2126A mutation12 or a null mutation13 within the Os05g43440 gene comprising SEQ ID NO: 1 or 2 (that encodes SEQ ID NO: 3).14
Prior art references CN107043410 and CN102177778 also teach obtaining starchy endosperm and/or thickened aleurone in rice plants/parts by mutating the Os05g43440/“TA” gene. At least CN107043410 also says that the Os05g43440 gene is recessive (i.e., a mutation thereof must be homozygously present15 to cause at least reduced starch or thickened aleurone). WO2017/083920 also specifies that thickened aleurone phenotype was observed when the “ta2” mutant was homozygously present.16
No other prior art references have been identified by the Office which may supplement the deficiencies of this specification.
Absent evidence to the contrary, it is not believed that the mutations described within the specification and prior art may cause a starchy endosperm and/or thickened aleurone in a cereal that is not rice. Furthermore, and absent evidence to the contrary, it is not believed that the mutations described within the specification and prior art may cause a starchy endosperm and/or thickened aleurone when not 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 and to specify that the genetic variation is homozygously present.
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.
Enablement:
Claim 35 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 has a reduced level or activity (2) of any mtSSB gene or its encoded protein, and wherein (3) the reduced level/activity is via any means, including a heterozygously present mutant allele. 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.
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”)17; (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”18).19
Regarding (A) the breadth of the claims:
The rejected claim recites (1) any cereal plant/part that has a reduced level or activity (2) of any mtSSB gene or its encoded protein, and wherein (3) the reduced level/activity is via any means, including a heterozygously present mutant allele. 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.20
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 (RE 3→) homozygously comprise a (RE 3→) G2126A mutation21 or a null mutation22 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.23
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 or aleurone thickness (see art rejections hereinabove); those teachings are limited to (RE 1→) rice, to (RE 2→) Os05g43440/TA, they also suggest that mutations must be (RE 3→) homozygously present to have a functional effect, and the (RE 3→) specific nature of the mutation which will have a useful functional impact is not known (hence the recommendations by the Office throughout this action that specifying the mutation structure within these claims would overcome the anticipation or obviousness rejections).
Furthermore, the inventors’/Applicant’s own post-filing publication LI et al.24 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 mutate Os05g43440/OsmtSSB (anywhere) and reasonably expect a phenotype change (especially when the mutation is only heterozygously present).
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. a cereal plant/part within claim 35 that is not rice and does not homozygously comprise a G2126A mutation within its Os05g43440 gene (comprising SEQ ID NO: 1 or 2 and encodes SEQ ID NO: 3).
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.25 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 mutation, at any location, present heterozygously); and because the specification and the prior art only teach mutating (the nature of which is unclear) the (RE 2) Os05g43440/TA gene (re 3) 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.26, “it is not reasonably predictable from the disclosure of one species, what other species will work.”27 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 modulate the expression of 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 modulations 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 mutation) causing the observed phenotype change (and not, for example, the modulation of a different gene and/or environmental factors). 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 routine28—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.
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 and to specify that the genetic variation is (RE 3→) G2126A (elected), (RE 3→) homozygously present, within (RE 2→) Os05g43440 (as defined by the sequences SEQ ID NO: 1 or 2). 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).
Conclusion
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 NO: 1 and it causing, when homozygously present within a rice plant/part, grain to have an at least thickened aleurone (as compared to a rice plant/part comprising at least one wild type Os05g43440/TA-1/OSmtSSB allele). Therefore, and based on the information provided at Examples 1-9 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 (see part (a) of claim 4) 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) (please see parts (b) and (c) of claim 4, which the Office believes correspond to the splice variants). 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.
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 at (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 CN107043410 at pages 4, 5, 8 of the English-language translation.
2 CN107043410 at page 8 of the English-language translation.
3 CN107043410 at page 11 of the English-language translation.
4 See the specification at page 96, lines 5-9 as well as Table 3 on page 94.
5 See Result 3 of the ABSS sequence search results file entitled “20260109_103533_us-18-255-184-1.rng”.
6 See Result 1 of the ABSS sequence search results file entitled “20260109_103533_us-18-255-184-2.rng”.
7 CN102177778 at pages 4-5 of the English-language translation.
8 WO2017/083920 at Example 5 on page 80.
9 WO2017/083920 at claims 41 and 46-48 on pages 106-107).
10 WO2017/083920 at Example 5 on page 80.
11 WO2017/083920 at claims 41 and 46-48 on pages 106-107).
12 See Examples 1-9 of the specification.
13 See Example 13 of the specification.
14 See Examples 1-9 of the specification.
15 CN107043410 at page 5 of the English language translation.
16 WO2017/083920 at Page 76.
17 MPEP § 2164.03.
18 MPEP § 2164.02(I).
19 MPEP § 2164.01(a) (citing In re Wands 858 F.2d 731 at 737; 8 USPQ2d 1400 at 1404 (Fed. Circ. 1988)).
20 Please note that if this claim did recite a functional/phenotypic effect, it would be rejected for a lack of Written Description.
21 See Examples 1-9 of the specification.
22 See Example 13 of the specification.
23 See Examples 1-9 of the specification.
24 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.
25 MPEP 2164.03 citing Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
26 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.
27 MPEP § 2164.03.
28 See MPEP § 2164.06.