Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 19-34 are pending and examined. Claims 1-18 have been cancelled.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(e) the invention was described in (1) an application for patent, published under section 122(b), by another filed in the United States before the invention by the applicant for patent or (2) a patent granted on an application for patent by another filed in the United States before the invention by the applicant for patent, except that an international application filed under the treaty defined in section 351(a) shall have the effects for purposes of this subsection of an application filed in the United States only if the international application designated the United States and was published under Article 21(2) of such treaty in the English language.
Claim(s) 28-33 is/are rejected under pre-AIA 35 U.S.C. 102(a) and (e) as being anticipated by Bird et al (Patent No. US 7,993,686 B1).
Claims 28-33 are drawn to wheat grain and flour made from wheat grain comprising various mutations and food and beverages comprising a component of said grain.
Bird et al disclose transformation of T. aestivum with dsRNA to inhibit expression of SBEIIa to increase amylose content (col. 44, Example 3; see also Example 6 and Table 4). Starch was isolated and analyzed from said grain (see Example 6) and can also be used to make flour and bread (see Example 12) or beverages (col. 28, last ¶).
Here, claims 29-33 are considered product-by-process claims: "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 799, 803, 218 USPQ 289, 292-33 (Fed. Cir. 1983). See MPEP 2113.
Because the grain and flour of claims 28-33 is processed and not required to have any of the genetic material or cells of the grain from which it is derived, said flour would be indistinguishable from that as disclosed by Bird et al as both plants lack SBEIIa protein.
Therefore, flour made from wheat grain comprising various mutations and food and beverages comprising a component of said grain is anticipated by Bird et al.
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 19, 22 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 5-7 of U.S. Patent No. 10,563,217 B2 (referred to herein as ‘217). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 19, 22 and 26 are drawn to an SBEIIa polynucleotide from Triticum turgidum L. spp durum encoding an SBEIIa polypeptide having a mutation wherein the mutation is W436* at a position corresponding to W436 of SEQ ID NO: 2 that is a stop codon or a splice junction mutation a position corresponding to G5073A of SEQ ID NO: 3 or G467E at a position corresponding to G467 of SEQ ID NO: 4, a wheat plant comprising one or more of said polynucleotides, wherein the one or more mutations are in each of the A and B genome, grain from said plant, flour or aa food product comprising a component of said grain, food or a beverage from said flour, and a plant part or progeny from said plant.
‘217 claims and SBEIIa polynucleotide from wheat encoding an SBEIIa polypeptide having a point mutation that is G467E at position G467 of SEQ ID NO: 4.
Therefore, at the time of filing of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive that the polynucleotide and plant as claimed because ‘217 claims the identical polynucleotide as instantly claimed.
Claims 19-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3-6, 8 and 9 of U.S. Patent No. 12,319,920 B2 (referred to herein as ‘920). Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 19-34 are drawn to an SBEIIa polynucleotide from Triticum turgidum L. spp durum encoding an SBEIIa polypeptide having a mutation wherein the mutation is W436* at a position corresponding to W436 of SEQ ID NO: 2 that is a stop codon or a splice junction mutation a position corresponding to G5073A of SEQ ID NO: 3 or G467E at a position corresponding to G467 of SEQ ID NO: 4, a wheat plant comprising one or more of said polynucleotides, wherein the one or more mutations are in each of the A and B genome, grain from said plant, flour or aa food product comprising a component of said grain, food or a beverage from said flour, and a plant part or progeny from said plant.
‘920 a Triticum turgidum ssp durum flour comprising one or more homozygous mutations in both SBEIIa alleles of each SBEIIa gene of the A and B genomes selected from: (i) the one or more mutations in the SBEIIa gene of the A genome is W436* at a position corresponding to W436 of SEQ ID NO:2; and the one or more mutations in the SBEIIa gene of the B genome is a splice junction mutation at a position corresponding to G5073A of SEQ ID NO: 3; and (ii) the one or more mutations in the SBEIIa gene of the A genome is W436* at a position corresponding to W436 of SEQ ID NO:2; and the one or more mutations in the SBEIIa gene of the B genome is G467E at a position corresponding to G467 of SEQ ID NO:4; wherein * indicates a stop codon, starch from said flour, food or a beverage comprising said flour and a method for making wheat grain comprising obtaining a wheat plant comprising said mutations, flour comprising said grain and starch from said flour and food or beverage comprising grain made by said method.
Therefore, at the time of filing of the instant invention it would have been prima facie obvious to one of ordinary skill in the art to arrive that the polynucleotide and plant as claimed because ‘920 to claims a flour and making flour that are identical to the flour and the method to make said flour requiring the polynucleotides as instantly claimed.
Conclusion
No claim is allowed.
Claims 19-27 and 34 appear to be free of the prior art. The closest prior art is Regina et al (Patent No. US 9,060,533 B2) which teaches point mutations in the SBEIIa gene but does not reasonably provide motivation for producing the particular mutations as claimed.
The closest prior art is also Nair et al (1997, Plant Science, 122:153-163), which teaches GenBank Accession numbers Y11282 having 100% and 98% sequence identity to SEQ ID NO: 2 and 4 of the instant invention, respectively:
Alignment of GenBank Accession numbers Y11282 with SEQ ID NO: 2 of the instant invention
RA Nair R.B., Baga M., Scoles G.J., Kartha K.K., Chibbar R.N.;
RT "Isolation, characterization and expression analysis of a starch branching
RT enzyme II cDNA from wheat.";
RL Plant Sci. 0:0-0(0).
DR EMBL; Y11282; CAA72154.1; -; mRNA.
Query Match 100.0%; Score 2813; Length 823;
Best Local Similarity 100.0%;
Matches 527; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MATFAVSGATLGVARPAGAGGGLLPRSGSERRGGVDLPSLLLRKKDSSRAVLSRAASPGK 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MATFAVSGATLGVARPAGAGGGLLPRSGSERRGGVDLPSLLLRKKDSSRAVLSRAASPGK 60
Qy 61 VLVPDGESDDLASPAQPEELQIPEDIEEQTAEVNMTGGTAEKLESSEPTQGIVETITDGV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VLVPDGESDDLASPAQPEELQIPEDIEEQTAEVNMTGGTAEKLESSEPTQGIVETITDGV 120
Qy 121 TKGVKELVVGEKPRVVPKPGDGQKIYEIDPTLKDFRSHLDYRYSEYRRIRAAIDQHEGGL 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TKGVKELVVGEKPRVVPKPGDGQKIYEIDPTLKDFRSHLDYRYSEYRRIRAAIDQHEGGL 180
Qy 181 EAFSRGYEKLGFTRSAEGITYREWAPGAHSAALVGDFNNWNPNADTMTRDDYGVWEIFLP 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 EAFSRGYEKLGFTRSAEGITYREWAPGAHSAALVGDFNNWNPNADTMTRDDYGVWEIFLP 240
Qy 241 NNADGSPAIPHGSRVKIRMDTPSGVKDSISAWIKFSVQAPGEIPFNGIYYDPPEEEKYVF 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 NNADGSPAIPHGSRVKIRMDTPSGVKDSISAWIKFSVQAPGEIPFNGIYYDPPEEEKYVF 300
Qy 301 QHPQPKRPESLRIYESHIGMSSPEPKINSYANFRDEVLPRIKRLGYNAVQIMAIQEHSYY 360
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 301 QHPQPKRPESLRIYESHIGMSSPEPKINSYANFRDEVLPRIKRLGYNAVQIMAIQEHSYY 360
Qy 361 ASFGYHVTNFFAPSSRFGTPEDLKSLIDRAHELGLLVLMDIVHSHSSNNTLDGLNGFDGT 420
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 361 ASFGYHVTNFFAPSSRFGTPEDLKSLIDRAHELGLLVLMDIVHSHSSNNTLDGLNGFDGT 420
Qy 421 DTHYFHGGPRGHHWMWDSRLFNYGSWEVLRFLLSNARWWLEEYKFDGFRFDGVTSMMYTH 480
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 421 DTHYFHGGPRGHHWMWDSRLFNYGSWEVLRFLLSNARWWLEEYKFDGFRFDGVTSMMYTH 480
Qy 481 HGLQMTFTGNYGEYFGFATDVDAVVYLMLVNDLIHGLHPDAVSIGED 527
|||||||||||||||||||||||||||||||||||||||||||||||
Db 481 HGLQMTFTGNYGEYFGFATDVDAVVYLMLVNDLIHGLHPDAVSIGED 527
Alignment GenBank Accession numbers Y11282 with SEQ ID NO: 4 of the instant invention
P93691_WHEAT
ID P93691_WHEAT Unreviewed; 823 AA.
AC P93691;
RA Nair R.B., Baga M., Scoles G.J., Kartha K.K., Chibbar R.N.;
RT "Isolation, characterization and expression analysis of a starch branching
RT enzyme II cDNA from wheat.";
RL Plant Sci. 0:0-0(0).
DR EMBL; Y11282; CAA72154.1; -; mRNA.
Query Match 98.2%; Score 4355; Length 823;
Best Local Similarity 98.4%;
Matches 811; Conservative 5; Mismatches 6; Indels 2; Gaps 2;
Qy 1 MATFAVSGATLGVARPASAGGGLL-RSGSERRGGVDLPSLLLRKKDSSRAVLSRAASPGK 59
||||||||||||||||| |||||| |||||||||||||||||||||||||||||||||||
Db 1 MATFAVSGATLGVARPAGAGGGLLPRSGSERRGGVDLPSLLLRKKDSSRAVLSRAASPGK 60
Qy 60 VLVPDGESDDLAATPAQPEELQIPEDIEEQTAEVNMTGGTAEKLQYSEPTQGIVETITDG 119
||||||||||| |:||||||||||||||||||||||||||||||: ||||||||||||||
Db 61 VLVPDGESDDL-ASPAQPEELQIPEDIEEQTAEVNMTGGTAEKLESSEPTQGIVETITDG 119
Qy 120 VTKGVKELVVGEKPRVVPKPGDGQKIYEIDPTLKDFRSHLDYRYSEYKRIRAAIDQHEGG 179
|||||||||||||||||||||||||||||||||||||||||||||||:||||||||||||
Db 120 VTKGVKELVVGEKPRVVPKPGDGQKIYEIDPTLKDFRSHLDYRYSEYRRIRAAIDQHEGG 179
Qy 180 LEAFSRGYEKLGFTRSAEGITYREWAPGAHSAALVGDFNNWNPNADTMTRDDYGVWEIFL 239
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 180 LEAFSRGYEKLGFTRSAEGITYREWAPGAHSAALVGDFNNWNPNADTMTRDDYGVWEIFL 239
Qy 240 PNNADGSPAIPHGSRVKIRMDTPSGVKDSISAWIKFSVQAPGEIPFNGIYYDPPEEEKYV 299
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 240 PNNADGSPAIPHGSRVKIRMDTPSGVKDSISAWIKFSVQAPGEIPFNGIYYDPPEEEKYV 299
Qy 300 FQHPQPKRPESLRIYESHIGMSSPEPKINSYANFRDGVLPRIKRLGYNAVQIMAIQEHSY 359
|||||||||||||||||||||||||||||||||||| |||||||||||||||||||||||
Db 300 FQHPQPKRPESLRIYESHIGMSSPEPKINSYANFRDEVLPRIKRLGYNAVQIMAIQEHSY 359
Qy 360 YASFGYHVTNFFAPSSRFGTPEDLKSLIDRAHELGLLVLMDIVHSHSSNNTLDGLNGFDG 419
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 360 YASFGYHVTNFFAPSSRFGTPEDLKSLIDRAHELGLLVLMDIVHSHSSNNTLDGLNGFDG 419
Qy 420 TDTHYFHGGPRGHHWMWDSRLFNYGSWEVLRFLLSNARWWLEEYKFDGFRFDGVTSMMYT 479
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 420 TDTHYFHGGPRGHHWMWDSRLFNYGSWEVLRFLLSNARWWLEEYKFDGFRFDGVTSMMYT 479
Qy 480 HHGLQMTFTGNYGEYFGFATDVDAVVYLMLVNDLIHGLYPDAVSIGEDVSGMPTFCIPVP 539
||||||||||||||||||||||||||||||||||||||:|||||||||||||||||||||
Db 480 HHGLQMTFTGNYGEYFGFATDVDAVVYLMLVNDLIHGLHPDAVSIGEDVSGMPTFCIPVP 539
Qy 540 DGGVGFDYRLHMAVADKWIELLKQSDESWKMGDIVHTLTNRRWLEKCVTYAESHDQALVG 599
||||| ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 540 DGGVGLDYRLHMAVADKWIELLKQSDESWKMGDIVHTLTNRRWLEKCVTYAESHDQALVG 599
Qy 600 DKTIAFWLMDKDMYDFMALDRPSTPRIDRGIALHKMIRLVTMGLGGEGYLNFMGNEFGHP 659
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 600 DKTIAFWLMDKDMYDFMALDRPSTPRIDRGIALHKMIRLVTMGLGGEGYLNFMGNEFGHP 659
Qy 660 EWIDFPRGPQTLPTGKVLPGNNNSYDKCRRRFDLGDADFLRYRGMQEFDQAMQHLEEKYG 719
|||||||||||||||||||||||||||||||||||||||||| |||||||||||||||||
Db 660 EWIDFPRGPQTLPTGKVLPGNNNSYDKCRRRFDLGDADFLRYHGMQEFDQAMQHLEEKYG 719
Qy 720 FMTSEHQYVSRKHEEDKVIIFERGDLVFVFNFHWSNSFFDYRVGCSKPGKYKVALDSDDA 779
||||||||||||||||||||||||||||||||||||||||||||||:|||||||||||||
Db 720 FMTSEHQYVSRKHEEDKVIIFERGDLVFVFNFHWSNSFFDYRVGCSRPGKYKVALDSDDA 779
Qy 780 LFGGFSRLDHDVDYFTTEHPHDNRPRSFLVYTPSRTAVVYALTE 823
|||||||||||||||||||||||||||| |||||||||||||||
Db 780 LFGGFSRLDHDVDYFTTEHPHDNRPRSFSVYTPSRTAVVYALTE 823
However, Nair et al does not reasonably teach, suggest or provide motivation for making the particular mutations as claimed, and does not provide a reasonable expectation of success for doing so.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JASON DEVEAU-ROSEN whose telephone number is (571)272-2828. The examiner can normally be reached 7:30am - 4pm.
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/JASON DEVEAU ROSEN/Primary Examiner, Art Unit 1662
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