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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/08/2026 has been entered.
Status of the Claims
Claims 5-6 and 20 are cancelled.
Claims 1-4, 7-19, and newly added 21-24 are pending.
Claims 9-17 and 21-24 are withdrawn from consideration.
Claims 1-4, 7-8, and 18-19 are examined herein.
Claims 1-3 are allowed.
Claims 4, 7-8, and 18-19 are rejected.
Priority
Application No. 18/064,423 filed on 12/12/2022 claims priority to provisional Application No. 63/265,393 filed on 12/14/2021.
Election/Restrictions
Newly submitted claims 21-24 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Elected claims 4, 7-8, and 18-19 are drawn to a method of restoring male-fertility in a male sterile plant, the method comprising introducing into a male-sterile plant genome at least one male fertility restoration genes operably linked to a polynucleotide encoding a screenable marker for seed selection that is at least 95% identical to SEQ ID NO: 6, and restoring male fertility by expressing the male-fertility restoration polynucleotide(s) (see claim 4). Alternatively, new independent claim 21 is drawn to a method of restoring male fertility in a male-sterile plant, comprising providing a male-sterile plant that comprises a chromosomal component from an alien species, the chromosomal component comprising one or more male-fertility restoration polynucleotides and a polynucleotide encoding a screenable marker for seed selection that is at least 95% identical to the amino acid sequence of SEQ ID NO: 6, and restoring male fertility by expressing the male-fertility restoration polynucleotide(s) (see claim 21). Thus, the new claim(s) require the additional limitations of a male-sterile plant that comprises a chromosomal component from an alien species and the chromosomal component comprises the male-fertility restoration polynucleotide and polynucleotide encoding a seed selection marker that is at least 95% identical to SEQ ID NO: 6. That is, the new claims encompass non-overlapping subject matter and the additional limitations require a different field of search.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-24 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 4, 7-8, and 18-19 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 4 recites the limitation "restoring male-fertility to the male sterile plant". There is only a previous recitation of a male-sterile plant genome, and not a male-sterile plant. Due to a lack of a previous recitation of a male-sterile plant, it is unclear if “the male-sterile plant” is a singular, original plant that comprises the male-sterile genome in the recitation of “introducing into a male-sterile genome”, or if “the male-sterile plant” encompasses any plant having the male-sterile genome and therefore encompasses progeny of the male-sterile plant. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination, the claims are broadly reasonably interpreted to encompass progeny of a male-sterile plant according to the specification that describes “plant” may also refer to genetically similar or identical progeny of that plant.
Claims 7-8 and 18-19 are rejected as a function of their dependency.
Claim 4 recites the limitation " the one or more homozygous mutations in an endogenous male-fertility polynucleotide". As a result of Applicant’s amendments, there is no longer a previous recitation of one or more homozygous mutations in an endogenous male-fertility polynucleotide. Therefore it is unclear what this recitation is in reference to and there is insufficient antecedent basis for this limitation in the claim.
Claims 7-8 and 18-19 are rejected as a function of their dependency.
Claim 4 recites the limitation “one or more male-fertility restoration polynucleotides operably linked to a polynucleotide encoding a screenable marker for seed selection”. However, the specification states the term “operably linked” refers to a functional linkage between a promoter or other regulatory element and an associated transcribable DNA sequence or coding sequence of a gene (or transgene), such that the promoter, etc., operates or functions to initiate, assist, affect, cause, and/or promote the transcription and expression of the associated transcribable DNA sequence or coding sequence, at least in certain cell(s), tissue(s), developmental stage(s), and/or condition(s) (¶0071). Therefore, because the specification provides a definition of “operably linked” that is the linkage between a promoter and a transcribable DNA sequence (gene), and the recitation in claim 4 is in reference to two genes (not a promoter and gene), it is unclear what is meant by “operably linked” in the context of claim 4. The metes and bounds of genes that may be considered “operably linked” is unclear. For purposes of examination, “linked” or “operably linked” is broadly reasonably interpreted to refer to any two elements that are on the same chromosome arm and therefore linked. This interpretation is based on Applicant’s description of Ms26, Ms9, and Ms45 being on the same chromosome arm as Ta-P1-4A and describes the genes as “linked”.
Claims 7-8 and 18-19 are rejected as a function of their dependency.
Claim 8 recites “The method of claim 4, wherein the promoter that expresses in seed is further operably linked to a regulatory element”. However, the specification states the term “operably linked” refers to a functional linkage between a promoter or other regulatory element and an associated transcribable DNA sequence or coding sequence of a gene (or transgene), such that the promoter, etc., operates or functions to initiate, assist, affect, cause, and/or promote the transcription and expression of the associated transcribable DNA sequence or coding sequence, at least in certain cell(s), tissue(s), developmental stage(s), and/or condition(s) (¶0071). Therefore, because the specification provides a definition of “operably linked” that is the linkage between a promoter and a transcribable DNA sequence (gene), and the recitation in claim 8 is in reference to a promoter and regulatory element (not a promoter/ regulatory element and gene), it is unclear what is meant by “operably linked” in the context of claim 8. The metes and bounds of genes that may be considered “operably linked” is unclear. For purposes of examination, “linked” or “operably linked” is broadly reasonably interpreted to refer to any two elements that are on the same chromosome arm and therefore linked. This interpretation is based on Applicant’s description of Ms26, Ms9, and Ms45 being on the same chromosome arm as Ta-P1-4A and describes the genes as “linked”.
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.
Claims 4, 7-8, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Cigan (US-20190177722-A1) and as evidenced by NCBI Accession No. VAH89079.1 (NCBI Accession No. VAH89079.1, published online 06/14/2019) and Uniprot Accession No. A0A9R0S831 (Uniprot No. A0A9R0S831, published online 09/13/2023).
Claim 4 is drawn to a method of restoring male fertility in a male-sterile plant, the method comprising: a) introducing into a male-sterile plant genome, one or more male-fertility restoration polynucleotides operably linked to a polynucleotide encoding a screenable marker for seed selection,
wherein the polynucleotide encoding the screenable marker encodes a polypeptide that is at least 95% identical to the amino acid sequence of SEQ ID NO:6,
wherein the polypeptide comprises MYB and P-protein domains and retains the ability to function as a screenable marker in seed selection,
wherein the polynucleotide encoding the screenable marker is operably linked to a promoter that expresses in seed, and
b) restoring male-fertility to the male-sterile plant by expression of the one or more male-fertility restoration polynucleotides that functionally complement a male-sterility phenotype caused by the one or more homozygous mutations in an endogenous male-fertility polynucleotide such that the male-sterile plant becomes male-fertile,
wherein the endogenous male-fertility polynucleotide is Ms9, Ms26, or Ms45 male-fertility polynucleotide, and
wherein the one or more male-fertility restoration polynucleotides is a Ms9, Ms26, or Ms45 male-fertility polynucleotide.
Claim 7 is drawn to the method of claim 4, wherein the promoter that expresses in seed is inserted or edited into the male-sterile plant genome so that it drives expression of the polynucleotide encoding the screenable marker.
Claim 8 is drawn to method of claim 4, wherein the promoter that expresses in seed is further operably linked to a regulatory element.
Claim 18 is drawn to the method of claim 4, wherein the one or more male-fertility restoration polynucleotides are inserted, edited, replaced, or repositioned in the male-sterile plant genome so as to be linked to the polynucleotide encoding the screenable marker, wherein the insertion, editing, replacement, or repositioning is carried out using gene editing technology, chromosomal rearrangement, or combinations thereof.
Claim 19 is drawn to the method of claim 4, wherein the polynucleotide encoding the screenable marker is inserted, edited, replaced, or repositioned in the male-sterile plant genome so as to be linked to the one or more male-fertility restoration polynucleotides, wherein the insertion, editing, replacement, or repositioning is carried out using gene editing technology, chromosomal rearrangement, or combinations thereof.
Regarding claim 4, Cigan teaches a method of producing a male sterile wheat plant by introducing a genetic modification into at least an endogenous Ms45 polynucleotide sequence in wheat plant cell, wherein the genetic modification confers male sterility to a wheat plant from the wheat plant cell, and obtaining the male sterile wheat plant from the wheat plant cell (Claim 1 of Cigan). Cigan teaches the Ms45 polynucleotide sequence encodes a polypeptide sequence of SEQ ID NO: 64 (claim 8 of Cigan). Cigan teaches the male-sterile plants are homozygous recessive for the fertility gene of Ms45 (i.e. nonfunctional copies), and teaches male-sterile plants may be restored to male fertility when a functional copy of the Ms45 fertility gene from the same or different species is used to complement the Ms45 mutation or introduced genetic modification (¶0128-0129). Cigan further teaches the method of claim 1, further comprising crossing the male-sterile wheat plant with a male-fertile wheat plant to produce a hybrid wheat seed (claim 10 of Cigan), therefore Cigan teaches introducing into a male-sterile plant genome a male fertility restoration polynucleotide. The instant disclosure also provides evidence that cross-pollinating male-sterile plants with male-fertile plants will produce progeny that will give rise to a mix of male- sterile and male-fertile plants (spec., ¶0007), therefore restoring male fertility.
However, Cigan does not explicitly teach in a single embodiment:
the male-fertility restoration polynucleotide is linked to a polynucleotide encoding a screenable marker for seed selection, wherein the polynucleotide encoding the screenable marker encodes a polypeptide that is at least 95% identical to the amino acid sequence of SEQ ID NO:6, wherein the polypeptide comprises MYB and P-protein domains and retains the ability to function as a screenable marker in seed selection, wherein the polynucleotide encoding the screenable marker is operably linked to a promoter that expresses in seed (remaining limitation of claim 4)
wherein the promoter that expresses in seed is inserted or edited into the male-sterile plant genome so that it drives expression of the polynucleotide encoding the screenable marker (claim 7)
wherein the promoter that expresses in seed is further operably linked to a regulatory element (claim 8)
wherein the one or more male-fertility restoration polynucleotides has are inserted, edited, replaced, or repositioned in the male-sterile plant genome so as to be linked to the polynucleotide encoding the screenable marker, wherein the insertion, editing, replacement, or repositioning is carried out using gene editing technology, chromosomal rearrangement, or combinations thereof (claim 18)
wherein the polynucleotide encoding the screenable marker is inserted, edited, replaced, or repositioned in the male-sterile plant genome so as to be linked to the one or more male-fertility restoration polynucleotides, wherein the insertion, editing, replacement, or repositioning is carried out using gene editing technology, chromosomal rearrangement, or combinations thereof (claim 19)
Regarding the remaining limitations of claim 4, in an alternative embodiment, Cigan teaches “wheat” includes tetraploid wheat including Triticum turgidum spp. Durum (i.e. durum wheat) which is a commercial variety having suitable agronomic characteristics (¶0195). An NCBI protein blast of SEQ ID NO: 64 taught by Cigan (endogenous Ms45 polypeptide) evidences the polypeptide is encoded by a gene on chromosome 4A of Triticum turgidum subsp. Durum (See NCBI Accession No. VAH89079.1, published online 06/14/2019). Additionally, an ABSS/Uniprot sequence search of SEQ ID NO: 6 evidences SEQ ID NO: 6 (at 100% identity) is encoded by a gene also found on chromosome 4a of Triticum turgidum subsp. Durum (See alignment below, and see file wrapper 20240809_113548_us-18-064-423-6.rup, Uniprot Accession No. A0A9R0S831, published online 09/13/2023). Because both the Ms45 and P1 genes are located on chromosome 4A of durum wheat, the genes are interpreted as “linked”. This interpretation is supported by the instant specification which describes genes on the same chromosome arm as “linked” (¶0107). Additionally, because the pericarp color 1 (P1) gene naturally imparts color to the seed pericarp, the P1 gene is reasonably interpreted to be operably linked to a promoter that expresses in seed (spec., ¶0013). Additionally, this P1 gene is reasonably interpreted as a “screenable marker” because it can be screened for/ is screenable.
RESULT 1
A0A9R0S831_TRITD
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID A0A9R0S831_TRITD Unreviewed; 346 AA.
AC A0A9R0S831;
DT 13-SEP-2023, integrated into UniProtKB/TrEMBL.
DT 13-SEP-2023, sequence version 1.
DT 29-MAY-2024, entry version 5.
DE SubName: Full=Uncharacterized protein {ECO:0000313|EMBL:VAH90088.1};
GN ORFNames=TRITD_4Av1G057610 {ECO:0000313|EMBL:VAH90088.1};
OS Triticum turgidum subsp. durum (Durum wheat) (Triticum durum).
OC Eukaryota; Viridiplantae; Streptophyta; Embryophyta; Tracheophyta;
OC Spermatophyta; Magnoliopsida; Liliopsida; Poales; Poaceae; BOP clade;
OC Pooideae; Triticodae; Triticeae; Triticinae; Triticum.
OX NCBI_TaxID=4567 {ECO:0000313|EMBL:VAH90088.1, ECO:0000313|Proteomes:UP000324705};
RN [1] {ECO:0000313|EMBL:VAH90088.1, ECO:0000313|Proteomes:UP000324705}
RP NUCLEOTIDE SEQUENCE [LARGE SCALE GENOMIC DNA].
RC STRAIN=cv. Svevo {ECO:0000313|Proteomes:UP000324705};
RG International Durum Wheat Genome Sequencing Consortium (IDWGSC);
RA Milanesi L.;
RL Submitted (SEP-2017) to the EMBL/GenBank/DDBJ databases.
CC ---------------------------------------------------------------------------
CC Copyrighted by the UniProt Consortium, see https://www.uniprot.org/terms
CC Distributed under the Creative Commons Attribution (CC BY 4.0) License
CC ---------------------------------------------------------------------------
DR EMBL; LT934117; VAH90088.1; -; Genomic_DNA.
DR SMR; A0A9R0S831; -.
DR Proteomes; UP000324705; Chromosome 4a.
DR GO; GO:0003677; F:DNA binding; IEA:UniProtKB-KW.
DR CDD; cd00167; SANT; 2.
DR Gene3D; 1.10.10.60; Homeodomain-like; 2.
DR InterPro; IPR009057; Homeobox-like_sf.
DR InterPro; IPR010588; Myb-rel_proteinP/Y1_C.
DR InterPro; IPR017930; Myb_dom.
DR InterPro; IPR001005; SANT/Myb.
DR PANTHER; PTHR47999:SF118; TRANSCRIPTION FACTOR MYB11-RELATED; 1.
DR PANTHER; PTHR47999; TRANSCRIPTION FACTOR MYB8-RELATED-RELATED; 1.
DR Pfam; PF00249; Myb_DNA-binding; 2.
DR Pfam; PF06640; P_C; 2.
DR SMART; SM00717; SANT; 2.
DR SUPFAM; SSF46689; Homeodomain-like; 1.
DR PROSITE; PS51294; HTH_MYB; 2.
DR PROSITE; PS50090; MYB_LIKE; 2.
PE 4: Predicted;
KW DNA-binding {ECO:0000256|ARBA:ARBA00023125};
KW Reference proteome {ECO:0000313|Proteomes:UP000324705}.
FT DOMAIN 9..61
FT /note="HTH myb-type"
FT /evidence="ECO:0000259|PROSITE:PS51294"
FT DOMAIN 9..61
FT /note="Myb-like"
FT /evidence="ECO:0000259|PROSITE:PS50090"
FT DOMAIN 62..116
FT /note="HTH myb-type"
FT /evidence="ECO:0000259|PROSITE:PS51294"
FT DOMAIN 62..112
FT /note="Myb-like"
FT /evidence="ECO:0000259|PROSITE:PS50090"
FT REGION 141..227
FT /note="Disordered"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
FT COMPBIAS 175..218
FT /note="Polar residues"
FT /evidence="ECO:0000256|SAM:MobiDB-lite"
SQ SEQUENCE 346 AA; 37723 MW; D2602CEF4CB5B132 CRC64;
Query Match 100.0%; Score 1833; Length 346;
Best Local Similarity 100.0%;
Matches 346; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MGRAPCCEKVGLKRGRWTAEEDDILANYIAKHGEGSWRSLPKNAGLLRCGKSCRLRWINY 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MGRAPCCEKVGLKRGRWTAEEDDILANYIAKHGEGSWRSLPKNAGLLRCGKSCRLRWINY 60
Qy 61 LRDGVRRGNISKEEDDLIVKLHATLGNRWSLIASHLPGRTDNEIKNYWNSHLSRQIHTFR 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 LRDGVRRGNISKEEDDLIVKLHATLGNRWSLIASHLPGRTDNEIKNYWNSHLSRQIHTFR 120
Qy 121 RIYTAVSDTAITVDVNKLSAAGKRRGGRTPGQSPRSSTKKKPVPEPITKAKDESSPAGAA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 RIYTAVSDTAITVDVNKLSAAGKRRGGRTPGQSPRSSTKKKPVPEPITKAKDESSPAGAA 180
Qy 181 SSVSSSPHSDEARSAVVDPDQNQPNNSISVSHTSDGPCSEDGTWPMVMDPVDQTGVLEAN 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SSVSSSPHSDEARSAVVDPDQNQPNNSISVSHTSDGPCSEDGTWPMVMDPVDQTGVLEAN 240
Qy 241 CTVDQQMGLWEVNSSMNQIGIMEDESEMQALLSSSVTAENGLVGIDPGGLSQVDDLLDMD 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 CTVDQQMGLWEVNSSMNQIGIMEDESEMQALLSSSVTAENGLVGIDPGGLSQVDDLLDMD 300
Qy 301 WEGFASHLWDQPAQNGLLQPAEPQAAKGSESDELESFVSWLLSDAC 346
||||||||||||||||||||||||||||||||||||||||||||||
Db 301 WEGFASHLWDQPAQNGLLQPAEPQAAKGSESDELESFVSWLLSDAC 346
Regarding claim 7, it is addressed above that durum wheat comprises the pericarp color 1 (P1) gene encoding SEQ ID NO: 6, and a promoter driving expression of the P1 gene. It is also addressed above that because the pericarp color 1 (P1) gene naturally imparts color to the seed pericarp, the promoter of the P1 gene therefore expresses in seed (spec., ¶0013). Based on this teaching and evidence, the step of crossing a male-fertile durum wheat plant to the male-sterile wheat plant (claims 1, 8, and 10 of Cigan, and ¶0195) is reasonably interpreted to encompass the instant limitation of wherein the promoter is inserted into the male-sterile plant genome so that it drives expression of the polynucleotide encoding the screenable marker.
Regarding claim 8, because both the Ms45 and P1 genes are located on chromosome 4A of durum wheat and are considered “linked”/ “operably linked” (see 112(b)) rejection above for interpretation), the promoters of these polynucleotides are also considered to be linked/operably linked. Therefore, the P1 promoter that expresses P1 gene and its encoded polynucleotide (SEQ ID NO: 6) in seed is reasonably interpreted to be further operably linked to a regulatory element that is the promoter of the Ms45 fertility polynucleotide.
Regarding claim 18, the Ms45 fertility restoration polynucleotide in the durum wheat plant as described above are broadly reasonably interpreted to be inserted into the male-sterile plant genome and linked to the pericarp color 1 (P1) polynucleotide (which encodes SEQ ID NO: 6) when the sterile and fertile plants are crossed, wherein the insertion is carried out using chromosomal rearrangement as a result of the crossing.
Regarding claim 19, similarly to the explanation to claim 18 above, the pericarp color 1 (P1) polynucleotide (which encodes SEQ ID NO: 6) in the durum wheat plant as described above are broadly reasonably interpreted to be inserted into the male-sterile plant genome and linked to the Ms45 fertility restoration polynucleotide when the sterile and fertile plants are crossed, wherein the insertion is carried out using chromosomal rearrangement as a result of the crossing.
Cigan teaches all of the limitations, with evidentiary support, but does not disclose a single embodiment having all of the limitations. As such, the claims are not rejected under 35 USC 102 but are instead rejected as obvious under 35 USC 103. It would have been obvious to one of ordinary skill in the art to combine the teachings of Cigan and cross the male sterile-wheat plant comprising homozygous ms45 mutations with a male fertile plant that is Triticum turgidum spp. Durum for the purpose of restoring male fertility with a complementary, functional Ms45 gene. Because the Ms45 restoration polynucleotide and the P1 polynucleotide are both on chromosome 4a in wheat durum at 100% sequence identity, and are therefore “linked”, the step of crossing the male-sterile wheat plant with the male-fertile durum wheat plant to produce hybrid wheat seed would satisfy all of the instantly claim limitations of claim 4. One of ordinary skill would have been motivated to combine these limitations and cross to Triticum turgidum spp. Durum because it is a commercial variety having suitable agronomic characteristics and is suitable for production of grain (¶0195), therefore it would be prima facie obvious to cross the male-sterile wheat plant with a male-fertile durum wheat plant to produce hybrid seed comprising the suitable agronomic characteristics of durum wheat. One of ordinary skill in the art would have a reasonable expectation of success because Cigan teaches the method can be applied to any wheat including durum wheat (claim 10 of Cigan, ¶0195).
Closest Prior Art
Claims 1-3 appear free of the prior art.
Regarding claims 1-3, the closest prior art is the closest prior art is Albertsen(b) (US Patent No. US-10155962-B2). Albertsen(b) teaches a method of conferring male fertility to a mutated MS45 male-sterile wheat plant wherein said method comprises introducing into said mutated MS45 male-sterile wheat plant a polynucleotide operably linked to a promoter that drives expression in the plant, said polynucleotide comprising a nucleotide sequence comprises at least 95% sequence identity to SEQ ID NO: 15 of Albertsen(b) (i.e. functional Ms45), wherein said nucleotide sequence confers male fertility to a mutated MS45 male-sterile plant when expressed in said plant; and expressing said polynucleotide in the plant to confer male fertility to the plant (claim 1 of Albertson(b)). Furthermore, Albertsen(b) also teaches the expression cassettes disclosed in Albertsen(b)'s invention may comprise a polynucleotide of interest encoding screenable markers including the p1 gene (Col. 14, lines 30-44).
However, Albertsen(b) does not disclose, teach, or otherwise render obvious wherein the polynucleotide is a nucleotide that encodes a polypeptide that is at least 95% identical to the amino acid sequence of SEQ ID NO: 6. There appears to be no previous identification in the prior art of a polynucleotide sequence encoding an amino acid sequence that is at least 95% identical to SEQ ID NO: 6 and is associated with or encodes a screenable marker. For this reason, it would not be obvious to arrive at this polynucleotide operably linked to a heterologous promoter that expresses in seed, wherein the polypeptide retains function as a screenable marker for seed selection.
Response to Arguments
Applicant argues beginning on p. 6 of remarks dated 05/08/2026 the
following arguments:
Claim Objections
Claim 4 is objected to for reasons set forth in the Office Action and claims 7-8 and 18- 20 are objected to as a function of their dependency. Claims 4, 7-8, and 18-19 are amended. Claim 20 is canceled. Applicant respectfully requests withdrawal of the objections.
Claim Rejection - 35 USC § 112 Indefiniteness
Claim 7 is rejected under 35 U.S.C. 112(b), as being indefinite for failing to
particularly point out and distinctly claim the invention. Claim 7 is amended. Applicant respectfully requests reconsideration and withdrawal of the 35 U.S.C. 112(b) rejection
Examiner’s Response:
In view of Applicant’s amendment’s, the previous objection and previous rejection under 35 USC 112(b) been withdrawn. However, Applicant’s amendments have introduced new issue’s and are now rejected under 35 USC 112(b) (see rejection above).
Applicant argues beginning on p. 6 of remarks dated 05/08/2026 the
following arguments:
Claim Rejections - 35 USC § 112 Written Description
Claims 1-3 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement. Claim 1 is amended to recite a nucleotide sequence which encodes a polypeptide with 95% identity to SEQ ID NO: 6. Support for these amendments may be found throughout the specification as filed, for example, at least at Example 2.
The specification provides a detailed framework supporting polynucleotides encoding polypeptides with high sequence identity (at least 95%) to SEQ ID NO: 6, including their functional equivalence as screenable markers. The specification explicitly contemplates polypeptides with 85%, 90%, 95%, 98%, 99%, and 100% identity to SEQ ID NO: 6 and related sequences (see paragraphs 13, 34, 40, 48, and 83). This language demonstrates that the inventors envisioned a genus of sequences with varying degrees of identity, including SEQ ID NO: 6.
Further, paragraph 58 describes fragments and variants of SEQ ID NO: 6 that retain biological activity, supporting the assertion that sequences with at least 95% identity can function as screenable markers. Example 2 and Table 2 provide experimental evidence of SEQ ID NO: 6 activity in wheat seeds, driven by a seed-specific promoter and enhancer. Example 2 also discusses the similarity between maize P1 and wheat P1 homologs on chromosome 4, particularly within the first 250 amino acids containing the MYB and P- domains.
The specification also includes detailed descriptions of promoters used to drive expression of SEQ ID NO: 6 and its variants (paragraphs 23-28; Examples 2 and 3), supporting the operable linkage and expression in seed tissues as required by the claims.
Written description "requires the disclosure of either a representative number of
species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can 'visualize or recognize' the members of the genus." AriadPharms., Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en banc) (quoting Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568-69 (Fed. Cir. 1997)). As Ariad explains, the law only requires disclosure of either representative examples (e.g., species) or common structure-not both. 598 F.3d at 1350; Ajinomoto Co., Inc. v. Int'l Trade Comm'n, 932 F.3d 1342, 1359-60 (Fed. Cir. 2019). The disclosure of "four examples of potent promoters" in Ajinomoto as a distinguishing feature because they provided guidance on methods for evaluation and strength of promoter performance, relative data, and a methodology for determining promoter strength. Id.
Furthermore, Ajinomoto held that "[a]dequate written description does not require a perfect correspondence between the members of the genus and the asserted common structural feature." Id. at 1360. The Federal Circuit in Ajinomoto rejected arguments that similarity to a consensus sequence is "not enough to predict the site and strength of a promoter from a given sequence" and found adequate written description. Ajinomoto, 932 F.3d at 1360 (explaining that the challenger's prediction-based argument assumed "too strict a legal standard"); Lifescan, PGR2019-00032, Paper 11 at 30 (rejecting argument that it would be impossible to "predict the behavior" of 5x1076 protein sequences covered by the claims because such arguments derived solely from the size of the genus rather than the factors informing a written-description analysis, including the state of the art). As the Supreme Court has explained, the "certainty which the law requires in patents is not greater than is reasonable." Amgen Inc. v. Sanofi, 598 U.S. 594, 611 (2023). Disclosed species are representative when they reflect the diversity of a claimed genus. AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d 1285, 1301 (Fed. Cir. 2014). Ajinomoto, 932 F.3d at 1359 (finding disclosure of four exemplary promoters and "background knowledge in the art" sufficient to support claims with no promoter sequence limitations). Ariad, 598 F.3d at 1352 ("[T]he written description requirement does not demand either examples or an actual reduction to practice . . .."); Sandoz, PGR2022-00037, Paper 11 at 17-18, 23-24, 29 ("there is no legal requirement that a patent specification must include test results or working examples").
The specification provides a detailed and enabling disclosure of SEQ ID NO: 6,
including its structure, function, and utility as a screenable marker. This, combined with the known structure-function relationships of P1 proteins, supports the inventors' possession of polypeptides with at least 95% identity to SEQ ID NO: 6. The amendments to the claims are consistent with the scope and level of identity supported by the specification and satisfy the written description requirement under 35 U.S.C. §112(a). Applicant respectfully requests reconsideration and withdrawal of the rejection.
Examiner’s Response:
In view of Applicant’s amendments, the previous rejection under 35 USC 112(a) written description has been withdrawn.
Applicant argues beginning on p. 8 of remarks dated 05/08/2026 the
following arguments:
Claim Rejections - 35 USC § 101
Claims 1 and 2 are rejected under 35 U.S.C. § 101 as being directed to a natural phenomenon without significantly more. Applicant respectfully submits that the rejection appears to be directed to claims 1 and 3, rather than claim 2, as claim 2 is directed to a recombinant DNA construct, which is not a natural phenomenon. Additionally, the discussion of the rejection on pages 9-10 of the Office Action refers to claim 3, not claim 2.
Claim 1 has been amended to recite that the polynucleotide is operably linked to a heterologous promoter that is expressed in seed. As amended, claim 1 is no longer directed to a natural phenomenon without significantly more, but instead recites a non-naturally occurring composition incorporating additional elements sufficient to confer eligibility. Accordingly, Applicant respectfully requests reconsideration and withdrawal of the rejection under 35 U.S.C. § 101.
Examiner’s Response:
In view of Applicant’s amendments to claim 1, which requires the promoter is operably linked to a heterologous promoter, the previous rejection under 35 USC 101 has been withdrawn.
Applicant argues beginning on p. 8 of remarks dated 05/08/2026 the
following arguments:
Applicant traverses the rejections to claims 1-3 under 35 USC 102 and 103 (see pages 8-12 of Remarks). The anticipation and obviousness rejections were made based upon instant SEQ ID NO: 3. Applicant has amended claim 1 to no longer encompasses other sequence identifiers and is limited to a polynucleotide that encodes a polypeptide that is at least 95% identical to the amino acid sequence set forth in SEQ ID NO: 6. In view of Applicant’s amendments, the previous rejections under 35 USC 102 and 103 have been withdrawn.
Additionally, upon further consideration claims 4, 7-8, and 18-19 are not free of the prior art (see 103 rejection above).
Conclusion
Claims 1-3 are allowed.
Claims 4, 7-8, and 18-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA N STOCKDALE whose telephone number is (703)756-5395. The examiner can normally be reached M-F 8:30-5:00 CT.
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.
JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662
Prosecution Insights