DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-6, 11-15, and 30-37 are pending.
Claims 11-15 are drawn to a non-elected invention and therefore withdrawn from consideration.
Claims 1-6 and 30-37 are examined herein.
Claims 1-6 and 30-37 are rejected.
Priority
Application No. 17/786,117 filed on 04/15/2024 is a 371 of PCT Application No. PCT/US20/65472 filed on 12/17/2020, which claims benefit to provisional Application No. 62/949,574 filed on 12/18/2019.
Election/Restrictions
Applicant’s election without traverse of Group I, encompassing claims 1-6 and 30-37 and Applicant’s election of species SEQ ID NO: 1 in the reply filed on 11/07/2025 is acknowledged.
Claim Interpretation
Claim 35 recites “The method of claim 30, wherein the targeted genetic modification is an expression modulating element (EME).” An expression modulation element (EME) is not explicitly defined in the instant disclosure. An EME is broadly reasonably interpreted as any targeted genetic modification that modulates gene expression.
Claim 36 recites “moderative constitutive promoter”. This term is not defined in the instant disclosure. A moderative constitutive promoter is reasonably interpreted as any constitutive promoter.
Claim Objections
Applicant is advised that should claims 1-5 be found allowable, claims 30-34 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
Written Description
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.
Claims 1-6 and 30-37 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.
The claims are broadly drawn to a method for increasing grain yield in a plant, the method comprising: a. introducing in a regenerable plant cell a targeted genetic modification at a genomic locus that encodes a BG1 polypeptide comprising an amino acid sequence that is at least 90% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51, 53, and 55; and b. generating the plant, wherein the level and/or activity of the encoded polypeptide is increased in the plant.
Specifically, the claims are broadly drawn to a BG1 polypeptide comprising an amino acid sequence that is as low as 90% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51, 53, and 55 that has the function of increasing grain yield in a plant.
Regarding elected SEQ ID NO: 1, Applicant describes in working examples increasing yield by increasing SEQ ID NO: 1 gene expression via methods including transgene overexpression (example 3), inserting a heterologous promoter upstream the native gene using CRISPR (example 7), and inserting an “expression modulation element” at -20 and -46 from the TATA box (example 8). Applicant only describes the BG1 protein of SEQ ID NO: 1 at 100% sequence identity increases grain yield.
Applicant has not described any sequence of the broadly claimed genus with less than 100% sequence identity to the recited sequence(s), let alone a sequence with as low as 90% sequence identity to the recited sequences, that effectively confers the function of a BG1 polypeptide and increases grain yield in a plant.
The prior art fails to remedy this deficiency. Regarding elected SEQ ID NO: 1, there appears to be a dearth of description at the time of filing of the amino acid sequences that would be expected to confer the function of a BG1 polypeptide and increase grain yield of a plant. A review of sequences that share identity with elected SEQ ID NO: 1 reveals sequences that have low sequence identity (see file wrapper 20250520_153035_us-17-786-117a-1.rapbm). For example, there is an identity gap exhibited below in two search results of SEQ ID NO: 1 that were available at the time of filing. One sequence shows 100% identity, and the next most similar sequence search that was available at the time of filing shows 72.6% identity:
RESULT 1
US-14-960-915-7
(NOTE: this sequence has 5 duplicates in the database searched.
See complete list at the end of this report)
Sequence 7, US/14960915
Publication No. US20160160231A1
GENERAL INFORMATION
APPLICANT: Academia Sinica
TITLE OF INVENTION: USE OF POLYPEPTIDES AND NUCLEIC ACIDS FOR IMPROVING PLANT GROWTH,
TITLE OF INVENTION: STRESS TOLERANCE AND PRODUCTIVITY
FILE REFERENCE: A0988.70063US01
CURRENT APPLICATION NUMBER: US/14/960,915
CURRENT FILING DATE: 2015-12-07
PRIOR APPLICATION NUMBER: US 62/088,852
PRIOR FILING DATE: 2014-12-08
NUMBER OF SEQ ID NOS: 11
SEQ ID NO 7
LENGTH: 316
TYPE: PRT
ORGANISM: Zea mays
Query Match 100.0%; Score 1605; Length 316;
Best Local Similarity 100.0%;
Matches 316; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MERWGDKDRGAAVPAPGRLRRYADQPSFSSSLLDAIYKSMDEPGDGATSAAAAGATKMQS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MERWGDKDRGAAVPAPGRLRRYADQPSFSSSLLDAIYKSMDEPGDGATSAAAAGATKMQS 60
Qy 61 HQDLHYSYYYKTSLAGSYRGSRAAAAAHAATTTSSSSECSSYGGFSSSEAESSQHRRLRP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 HQDLHYSYYYKTSLAGSYRGSRAAAAAHAATTTSSSSECSSYGGFSSSEAESSQHRRLRP 120
Qy 121 IRTSVGAAASPAPAPEKKKKAGANIRAKLRDLRKPASPGARLAGFLNTIFSGRRAPATPP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 IRTSVGAAASPAPAPEKKKKAGANIRAKLRDLRKPASPGARLAGFLNTIFSGRRAPATPP 180
Qy 181 SRGAESSACSTASSYSRSCLSKTPSTRGQPKRTVRFLDSDDGEAAAAAPGGERRRVQVGV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SRGAESSACSTASSYSRSCLSKTPSTRGQPKRTVRFLDSDDGEAAAAAPGGERRRVQVGV 240
Qy 241 AELERMLLHRMEMDSDEDDEDEEGSDASSDLFDLENFAAGAPDAAAAYRDELPVYETTRV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AELERMLLHRMEMDSDEDDEDEEGSDASSDLFDLENFAAGAPDAAAAYRDELPVYETTRV 300
Qy 301 VLGHRAIGHGRSARVV 316
||||||||||||||||
Db 301 VLGHRAIGHGRSARVV 316
RESULT 8
US-14-910-437B-25
(NOTE: this sequence has 2 duplicates in the database searched.
See complete list at the end of this report)
Sequence 25, US/14910437B
Publication No. US20160251673A1
GENERAL INFORMATION
APPLICANT: INSTITUTE OF GENETICS AND DEVELOPMENTAL BIOLOGY CHINESE
APPLICANT: ACADEMY OF SCIENCES
TITLE OF INVENTION: BG1 COMPOSITIONS AND METHODS TO INCREASE AGRONOMIC PERFORMANCE OF
TITLE OF INVENTION: PLANTS
FILE REFERENCE: RTS16139C
CURRENT APPLICATION NUMBER: US/14/910,437B
CURRENT FILING DATE: 2016-05-17
PRIOR APPLICATION NUMBER: CN201310343713.3
PRIOR FILING DATE: 2013-08-08
NUMBER OF SEQ ID NOS: 75
SEQ ID NO 25
LENGTH: 327
TYPE: PRT
ORGANISM: Setaria italica
Query Match 72.6%; Score 1165.5; Length 327;
Best Local Similarity 76.1%;
Matches 261; Conservative 10; Mismatches 29; Indels 43; Gaps 14;
Qy 1 MERWGDKDRGAAVPAPGRLRRYADQPSFSSSLLDAIYKSMDEPGDGATSAAAAGATKMQS 60
|||||:| | ||||| |||||||||||:|||||||||||| |||| || ||
Db 1 MERWGEK---GAAPAPGRARRYADQPSFSSTLLDAIYKSMDEP-----DAAAAATTKKQS 52
Qy 61 HQDLHYSYYYKTSLAGSYRGSRAAAAA-----HAATTTSSSSECSSYGGFSSSEAESSQH 115
|||||||||| ||||||| |||:| || ||||||||||||||||||||||||
Db 53 -QDLHYSYYYKASLAGSYRAGRAASAVATPGPHA--TTSSSSECSSYGGFSSSEAESSQH 109
Qy 116 RRLRPIRTSVGAAA-SPAPAPEKKKKA-----GANIRAKLRDLRKPASPGARLAGFLNTI 169
|||||||||| || :||||||| ||| |||||||||||||||||||||||||| |
Db 110 RRLRPIRTSVAAAGEAPAPAPEKTKKAAKNKPGANIRAKLRDLRKPASPGARLAGFLNAI 169
Qy 170 FSGRRAPATPPS----RGAESSACSTASSYSRSCLSKTPSTRGQPKRTVRFLDSDDGEAA 225
|:|:||| |||| | ||||:|||||||||||||||||||||||||:||| |||
Db 170 FNGKRAPPTPPSASRAAAASESACSSASSYSRSCLSKTPSTRGQPKRTVRFMDSDT-EAA 228
Qy 226 AAAP--GGERRRVQVGVAELERMLLHRMEMDSDEDDEDEEGSDASSDLFDLENFAAGAPD 283
|| | | ||||||||| |||||||||||||||||| | ||||||||:|||||| ||
Db 229 AAVPAAGTERRRVQVGVVELERMLLHRMEMDSDEDD---ESSDASSDLFELENFAAVAPA 285
Qy 284 A--AAAYRDELPVYETTRVVLGHRAIG--------HGRSARVV 316
| | |||||||||||||||| :|||| |||| |||
Db 286 AGGAGAYRDELPVYETTRVVL-NRAIGHGHGHGYAHGRSTRVV 327
The instant specification does not provide enough sequences to describe the
genus of amino acid sequences encoding BG1 proteins between the recited gaps that are able to effectively confer the functions of a BG1 protein. As such, the structural features that distinguish BG1 proteins with polypeptides comprising 90% sequence identity to SEQ ID NO: 1 from other polypeptides with 90% sequence identity to SEQ ID NOs: 1 that confer the function of a BG1 polypeptide and increase grain yield in a plant are not described in the instant specification. The limited examples of 100% identity to the recited sequences do not describe the claimed genus by virtue of example. As described above, there also appears to be a dearth of description of amino acid sequences of BG1 proteins with less than 100% sequence identity that would be expected to have the required function of a BG1 protein and confer the trait of increased grain yield in plants. Therefore, one of ordinary skill in the art would not have recognized the Applicant to be in possession of the claimed invention at the time the application was filed.
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 1-6 and 30-37 are rejected under 35 U.S.C. 103 as being unpatentable over Chu (US-20160251673-A1).
Claims 1 and 30 are drawn to a method for increasing grain yield in a plant, the method comprising: a. introducing in a regenerable plant cell a targeted genetic modification at a genomic locus that encodes a BG1 polypeptide comprising an amino acid sequence that is at least 90% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51, 53, and 55; and b. generating the plant, wherein the level and/or activity of the encoded polypeptide is increased in the plant.
Claims 2 and 31 are drawn to the method of claim 1 or 30, wherein the polynucleotide encodes a BG1 polypeptide comprising an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51, 53, and 55.
Claims 3 and 32 are drawn to the method of claim 1 or 30, wherein the targeted genetic modification is introduced using a genome modification technique selected from the group consisting of a polynucleotide-guided endonuclease, CRISPR-Cas endonucleases, base editing deaminases, a zinc finger nuclease, a transcription activator-like effector nuclease (TALEN), engineered site-specific meganucleases, or Argonaute.
Claims 4 and 33 are drawn to the method of claim 1 or 30, wherein the targeted genetic modification is present in (a) the coding region; (b) a non-coding region; (c) a regulatory sequence; (d) an untranslated region; or (e) any combination of (a)-(d) of the genomic locus that encodes a polypeptide comprising an amino acid sequence that is at least 90% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51, 53, and 55.
Claims 5 and 34 are drawn to the method of claim 1 or 30, wherein the plant is maize.
Claim 6 is drawn to the method of claim 1, wherein the plant is selected from the group consisting of soybean, pea, rice, wheat, sorghum, barley, alfalfa and brassica.
Claim 35 is drawn to the method of claim 30, wherein the targeted genetic modification is an expression modulating element (EME).
Claim 36 is drawn to the method of claim 30, wherein the targeted genetic modification is insertion of a moderative constitutive promoter.
Claim 37 is drawn to the method of claim 30, wherein the targeted genetic modification is insertion of a moderative constitutive promoter designated maize GOS2.
Regarding claims 1 and 30, Chu teaches an invention related to BG1 compositions and methods to increase agronomic performance of plants (title), and teaches increased expression of BG1 results in increased grain size and yield (abstract). Chu teaches methods of improving yield of a plant include increasing the expression of a polynucleotide that encodes a polypeptide comprising the amino acid sequence selected from the group consisting of SEQ ID NOS: 1 or 4-27 (¶0011, 0032) which includes SEQ ID NO: 14, and SEQ ID NO: 14 of Chu has 100% identity to instant SEQ ID NO: 1 (see alignment below).
Regarding claims 2 and 31, Chu teaches a BG1 polypeptide, SEQ ID NO: 14, that has 100% identity to instant SEQ ID NO: 1 (see alignment below).
Regarding claims 5 and 34, Chu teaches the plant is maize (¶0045, 0067, 0085).
Regarding claim 6, Chu teaches preferred plants containing the polynucleotides of the present disclosure include but are not limited to maize, soybean, sunflower, sorghum, canola, wheat, alfalfa, cotton, rice, barley, tomato and millet (¶0045, 0067, 0085).
However, Chu does not explicitly teach in a single embodiment:
a targeted genetic modification is introduced at a genomic locus encoding a BGP1 polypeptide comprising an amino acid sequence that is at least 90% identical to an amino acid sequence of SEQ ID NO: 14 (remaining limitation of claims 1 and 30)
wherein the targeted genetic modification is introduced using a genome modification technique selected from the group consisting of a polynucleotide-guided endonuclease, CRISPR-Cas endonucleases, base editing deaminases, a zinc finger nuclease, a transcription activator-like effector nuclease (TALEN), engineered site-specific meganucleases, or Argonaute (claims 3 and 32).
wherein the targeted genetic modification is present in (a) the coding region; (b) a non-coding region; (c) a regulatory sequence; (d) an untranslated region; or (e) any combination of (a)-(d) of the genomic locus that encodes a polypeptide comprising an amino acid sequence that is at least 90% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51, 53, and 55 (claims 4 and 33)
wherein the targeted genetic modification is an expression modulating element (EME) (claim 35)
wherein the targeted genetic modification is insertion of a moderative constitutive promoter (claim 36)
wherein the targeted genetic modification is insertion of a moderative constitutive promoter designated maize GOS2 (claim 37)
Regarding the remaining limitations of claims 1 and 30 and claims 3 and 32, Chu teaches in an alternative embodiment the CRISPR/Cas system allows targeted cleavage of genomic DNA, and based on the disclosure of the BG1 coding sequences, polypeptide sequences of the orthologs/homologs and the genomic DNA sequences, site-directed mutagenesis can be readily performed to generate plants expressing a higher level of the BG1 polypeptide or an ortholog thereof (¶0152).
Regarding claims 4 and 33, Chu also teaches in general, methods to modify or alter the host endogenous genomic DNA are available and includes altering the host native DNA sequence or a pre-existing transgenic sequence including regulatory elements, coding and non-coding sequences.
Regarding claim 35, because Chu teaches CRISPR site-directed mutagenesis can be readily performed to generate plants expressing a higher level of the endogenous BG1 polypeptide or an ortholog thereof (¶0152), this targeted genetic modification described by Chu is broadly reasonably interpreted as an expression modulating element (see claim interpretation above).
Regarding claim 36, Chu teaches in an alternative embodiment overexpressing BG1 in rice using an expression vector that drives BG1 cDNA under the control of the rice ACTIN promoter, as well as overexpressing OsBG1 in Arabidopsis under control of the cauliflower mosaic virus 35S promoter (35S) (¶0175) (i.e. rice ACTIN1 and CaMV 35S are constitutive promoters). Chu teaches in both instances grain/seed size increased (¶0175). Chu also teaches in general, methods to modify or alter the host endogenous genomic DNA are available, and includes altering the host native DNA sequence or a pre-existing transgenic sequence including regulatory elements (i.e. the promoter) (¶0152).
Regarding claim 37, Chu teaches in an alternative embodiment suitable constitutive promoters include for example, Ubiquitin promoters, actin promoters, and GOS2 promoter (¶0095).
Chu teaches all of the limitations of the rejected claims in alternative embodiments, but does not disclose a single embodiment having all the limitations. As such, the claims are not rejected as anticipated under 35 USC §102 but are instead rejected as obvious under 35 USC §103. One of ordinary skill in the art would have been motivated to combine the limitations as taught by Chu into a single embodiment to arrive at Applicant’s claimed inventions because each limitation is explicitly taught as an alternative embodiment of the invention. It would therefore be obvious to combine the methods taught by Chu for the purpose of expressing a higher level of the endogenous BG1 polypeptides explicitly taught by Chu (¶0152) to increase agronomic performance of plants including increasing grain size and yield (title, abstract). One having ordinary skill in the art would have a reasonable expectation of success because Chu explicitly teaches based on the disclosure of the BG1 coding sequences, polypeptide sequences of the orthologs/homologs and the genomic DNA sequences, site-directed mutagenesis can be readily performed to generate plants expressing a higher level of the endogenous BG1 polypeptide or an ortholog thereof (¶0152), and teaches a BG1 polynucleotide sequence (i.e. SEQ ID NO: 14 of Chu) that has 100% sequence identity to instant SEQ ID NO: 1. Furthermore, it would therefore have been obvious to a person of ordinary skill in the art to modify the invention taught by Chu to combine the limitations to arrive at the instantly claimed method of inserting a constitutive promoter at a genomic locus encoding a BG1 polypeptide with a reasonable expectation of success because Chu teaches in one embodiment using a recombinant expression vector that overexpressed BG1 driven by a constitutive promoter increased grain size, and teaches in an alternative embodiment CRISPR can be used to alter endogenous DNA sequences including regulatory sequences (i.e. promoter sequences), and insertion of the constitutive promoters, including a maize GOS2 promoter, taught by Chu upstream the endogenous BG1 sequence using targeted modification methods such as CRISPR could be achieved by one of ordinary skill in the art without encountering any special technical difficulties. One having ordinary skill in the art would have been motivated to combine the teachings into a single embodiment for the same purpose of overexpressing BG1 to increase grain size and yield (abstract).
Alignments
Alignment of instant SEQ ID NO: 1 (Qy) with SEQ ID NO: 14 taught by Chu (Db):
ALIGNMENT:
Query Match 100.0%; Score 1605; Length 316;
Best Local Similarity 100.0%;
Matches 316; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MERWGDKDRGAAVPAPGRLRRYADQPSFSSSLLDAIYKSMDEPGDGATSAAAAGATKMQS 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MERWGDKDRGAAVPAPGRLRRYADQPSFSSSLLDAIYKSMDEPGDGATSAAAAGATKMQS 60
Qy 61 HQDLHYSYYYKTSLAGSYRGSRAAAAAHAATTTSSSSECSSYGGFSSSEAESSQHRRLRP 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 HQDLHYSYYYKTSLAGSYRGSRAAAAAHAATTTSSSSECSSYGGFSSSEAESSQHRRLRP 120
Qy 121 IRTSVGAAASPAPAPEKKKKAGANIRAKLRDLRKPASPGARLAGFLNTIFSGRRAPATPP 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 IRTSVGAAASPAPAPEKKKKAGANIRAKLRDLRKPASPGARLAGFLNTIFSGRRAPATPP 180
Qy 181 SRGAESSACSTASSYSRSCLSKTPSTRGQPKRTVRFLDSDDGEAAAAAPGGERRRVQVGV 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 SRGAESSACSTASSYSRSCLSKTPSTRGQPKRTVRFLDSDDGEAAAAAPGGERRRVQVGV 240
Qy 241 AELERMLLHRMEMDSDEDDEDEEGSDASSDLFDLENFAAGAPDAAAAYRDELPVYETTRV 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 AELERMLLHRMEMDSDEDDEDEEGSDASSDLFDLENFAAGAPDAAAAYRDELPVYETTRV 300
Qy 301 VLGHRAIGHGRSARVV 316
||||||||||||||||
Db 301 VLGHRAIGHGRSARVV 316
DUPLICATES:
US-14-910-437B-14
Filing date in PALM: 2016-02-05
Sequence 14, US/14910437B
Publication No. US20160251673A1
GENERAL INFORMATION
APPLICANT: INSTITUTE OF GENETICS AND DEVELOPMENTAL BIOLOGY CHINESE
APPLICANT: ACADEMY OF SCIENCES
TITLE OF INVENTION: BG1 COMPOSITIONS AND METHODS TO INCREASE AGRONOMIC PERFORMANCE OF
TITLE OF INVENTION: PLANTS
FILE REFERENCE: RTS16139C
CURRENT APPLICATION NUMBER: US/14/910,437B
CURRENT FILING DATE: 2016-05-17
PRIOR APPLICATION NUMBER: CN201310343713.3
PRIOR FILING DATE: 2013-08-08
NUMBER OF SEQ ID NOS: 75
SEQ ID NO 14
LENGTH: 316
TYPE: PRT
ORGANISM: Zea mays
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6 and 30-37 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-8, 17-19,and 30 of copending Application No. 17/786,137 in view of Chu (US-20160251673-A1).
The copending application is drawn to a method of increasing yield of a plant, the method comprising increasing the expression of a polynucleotide encoding an amino acid sequence that is at least 95% identical to an amino acid sequence selected from the group consisting of SEQ ID NOs: 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 31, 33, 35, 41, 43, 45, 47, 49, 51 ,53, and 55 in a plant, wherein the polynucleotide is operably linked to a heterologous regulatory element; and growing the plant in a crop growing environment. The copending application is further drawn to the same instantly claimed plants, and also wherein the regulatory element is a moderative constitutive heterologous promoter including a maize GOS2 promoter.
However, the copending application is not explicitly drawn to a targeted modification in the genomic locus encoding a BG1 polypeptide.
In analogous art, Chu teaches an invention related to BG1 compositions and methods to increase agronomic performance of plants (title), and teaches increased expression of BG1 results in increased grain size and yield (abstract). Chu teaches methods of improving yield of a plant include increasing the expression of a polynucleotide that encodes a polypeptide comprising the amino acid sequence selected from the group consisting of SEQ ID NOS: 1 or 4-27 (¶0011, 0032) which includes SEQ ID NO: 14, and SEQ ID NO: 14 of Chu has 100% identity to instant SEQ ID NO: 1 and SEQ ID NO: 1 of the copending application. Chu teaches in an alternative embodiment overexpressing BG1 in rice using an expression vector that drives BG1 cDNA under the control of the rice ACTIN promoter, as well as overexpressing OsBG1 in Arabidopsis under control of the cauliflower mosaic virus 35S promoter (35S) (¶0175) (i.e. rice ACTIN1 and CaMV 35S are constitutive promoters). Chu teaches in both instances grain/seed size increased (¶0175). Chu also teaches in general, methods to modify or alter the host endogenous genomic DNA are available, and includes altering the host native DNA sequence or a pre-existing transgenic sequence including regulatory elements (i.e. the promoter) (¶0152). Chu teaches the CRISPR/Cas system allows targeted cleavage of genomic DNA, and based on the disclosure of the BG1 coding sequences, polypeptide sequences of the orthologs/homologs and the genomic DNA sequences, site-directed mutagenesis can be readily performed to generate plants expressing a higher level of the endogenous BG1 polypeptide or an ortholog thereof (¶0152).
It would therefore have been obvious to a person of ordinary skill in the art to modify the invention taught by Chu to combine the limitations to arrive at the instantly claimed method of inserting a constitutive promoter at a genomic locus encoding a BG1 polypeptide with a reasonable expectation of success because Chu teaches in one embodiment using a recombinant expression vector that overexpressed BG1 driven by a constitutive promoter increased grain size, and teaches in an alternative embodiment CRISPR can be used to alter endogenous DNA sequences including regulatory sequences (i.e. promoter sequences), and insertion of the constitutive promoters, including a maize GOS2 promoter, taught by Chu upstream the endogenous BG1 sequence using targeted modification methods such as CRISPR could be achieved by one of ordinary skill in the art without encountering any special technical difficulties. One having ordinary skill in the art would have been motivated to combine the teachings into a single embodiment for the same purpose of overexpressing BG1 to increase grain size and yield (abstract).
This is a provisional nonstatutory double patenting rejection.
Conclusion and Inquiries
No claims are allowed.
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JESSICA N. STOCKDALE
Examiner
Art Unit 1663
/JESSICA NICOLE STOCKDALE/Examiner, Art Unit 1663
/CHARLES LOGSDON/Primary Examiner, Art Unit 1662