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 .
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Claims 20-21, 44, and 64-74, pending in this application, are examined.
Information Disclosure Statement
The listing of references in the specification, on pages 58-60, is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112
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 20-21, 44, and 64-74 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The purpose of the written description is to ensure that the inventor had possession at the time the invention was made, of the specific subject claimed. For a broad generic claim, the specification must provide adequate written description to identify the genus of the claim.
The Federal Circuit has recently clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398; 1406 (Fed. Cir. 1997). In summary, the court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. The court goes on to say, "A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNAs, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to members of the genus, which features constitute a substantial portion of the genus." See University of California v. Eli Lilly and Co., 119 F.3d 1559; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
The claims are broadly drawn a process for determining whether a polypeptide confers resistance or susceptibility to one or more biotrophic fungal pathogens by obtaining a polynucleotide operably linked to a promoter, wherein the polynucleotide encodes a polypeptide having at least 80% or 90% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; the polynucleotide having at least 80% identity to SEQ ID NO: 2 or 3, wherein the biotrophic fungal pathogens is one of Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici.
The specification describes SEQ ID NO: 1 and homologs thereof identified as SEQ ID NO: 7, 8, and 9. The specification has described SEQ ID NO: 1 from wheat as the only resistance Lr67 polypeptide that confers resistance to fungal pathogens. In addition, search results of SEQ ID NO: 1 does not reveal other polypeptides sequences having 80% identity to SEQ ID NO: 1 and having antifungal activities. At page 52 of the specification, SEQ ID NO: 1 share 89-93% identity to the homologous polypeptides in cereals and 80% identity to the homolog in Arabidopsis. However, the antifungal resistance activity of the homologous genes from rice and Arabidopsis thaliana is unknown.
Furthermore, a polypeptide having from 80% identity to SEQ ID NO: 1 would have multiple amino acid residues substitutions relative to the 514 amino acid residues. Therefore, the genus of polypeptides/polynucleotide having 80% or 85% identity read on sequences that are functionally and structurally unrelated to SEQ ID NO: 1, 7, 8 or 9. Further, the claims recite “a sequence as provided in SEQ ID NO:” which creates a large genus of sequences of any size unrelated to SEQ ID NO: 1, 7, 8 or 9. Therefore, the specification fails to describe a representative species of an exogenous polynucleotide encoding a polypeptide that confers resistance to fungal pathogens in transgenic plants. Neither the instant specification nor the prior art describes structural features/domains common to all the polynucleotides/ polypeptides that would allow one to recognize the identity of the members of the genus.
Therefore, for all the reasons discussed above, the specification fails to describe a sufficient number of species across the breadth of the claimed genus so as to show Applicant had possession of the claimed genus of polypeptide/polynucleotide sequences 80% or 85%% identity to SEQ ID NO: 1, 7, 8 or 9 at the time the present invention was made. Since the specification fails to sufficiently describe the sequences, methods that employ with said sequences are similarly not described. Therefore, the claims lack sufficient written description.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 44 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a is a natural phenomenon, without significantly more. The claim(s) recite(s) a method of identifying a plant comprising a polynucleotide encoding a polypeptide comprising a polypeptide having SEQ ID NO: 1, 7, 8 or 9, that does not comprise a glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1 by obtaining a nucleic acid sample from a plant and screening the sample for the presence or absence of the polynucleotide. This judicial exception is not integrated into a practical application because the method does not produce a new plant or a plant with new genotype. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because a “patent must do more than simple state the law of nature which adding the words “apply”. See, e.g. Gottschalk v. Benson 409 U.S. 63:71-72. The steps of “obtaining a nucleic acid from a sample” and “screening the sample” does not transform the plant or the nucleic acid sample, therefore are not sufficient to transform unpatentable natural phenomenon into patentable application. Identifying and selecting/screening can be performed by using bioinformatics software to search for the polynucleotide associated with rust resistance in a wheat/Arabidopsis/soybean database of known and sequenced variety, following selection performed observing and noting the search results as to which plants contain the polynucleotide.
According to the MPEP 2106, a claim that is directed to a judicial exception when a law of nature is recited in the claim; such a claim requires a closer scrutiny for eligibility because of the risk it will “tie up” the excepted subject matter and pre-empt others from using the law of nature. Mayo, 132 S. Ct. at 1301 states "([E]ven though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are ‘the basic tools of scientific and technological work.’ And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute when a patented process amounts to no more than an instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify’’ (quoting Gottschalk v. Benson, 409 U.S. 63, 67 (1972)).
Therefore, claim 44 does not constitute steps of a patentable process.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 20-21 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,421,246 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant application and the issued patent recite a plant comprising an introduced polynucleotide encoding a polypeptide which comprises amino acids having at least 85% or 90% identical to the amino acid sequence of any one or more of SEQ ID NO: 1, 7, 8 or 9; wherein the polypeptide does not contain a glycine at a position corresponding to amino acid residue 144 of SEQ ID NO: 1. The claims of the instant application are drawn to a process for determining whether a polypeptide confers resistance or susceptibility to one or more biotrophic fungal pathogens by obtaining a polynucleotide operably linked to a promoter, wherein the polynucleotide encodes a polypeptide having at least 80%, 85% or 90% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; wherein the biotrophic fungal pathogens is one of Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici. The claims of the issued patent are drawn to a transgenic or genetically modified plant comprising a gene encoding an Lr67 polypeptide having at least 90%, 95% or 99% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the gene has a genetic modification such that the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; said plant, wherein the Lr67 polypeptide confers upon the plant resistance to biotrophic fungal pathogens Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici; and a method of producing said plant. Issued patent claims recite “at least 90%, 95% or 99% sequence identity” to SEQ ID NO: 7, 8 or 9; while the claims of instant application recite “at least 80% or 85% sequence identity “ to SEQ ID NO:1, 7, 8 or 9. Therefore, the claims of the instant application are broader in scope and encompass the claims of the issued patent.
Therefore, the claimed invention is obvious over the claims of the issued patent.
Claims 20-21 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11, 14, 22 and 26-27 of U.S. Patent No. 9,994,864. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant application and the issued patent are drawn to a process for determining whether a polypeptide confers resistance or susceptibility to one or more biotrophic fungal pathogens by obtaining a polynucleotide operably linked to a promoter, wherein the polynucleotide encodes a polypeptide having SEQ ID NO: 1, 7, 8 or 9, wherein the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; wherein the biotrophic fungal pathogens is one of Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici. Claims 20 and 64-74 of instant application recite “at least 80% or 85% sequence identity to SEQ ID NO: 1, 7, 8 or 9”, while claims 22 and 26-27 of the issued patent recite “at least 95% sequence identity to SEQ ID NO: 1, 7, 8 or 9”. Therefore, the claims of instant application are broader in scope and encompass the claims of the issued patent”. The claims of the instant application are also obvious to the transgenic plant/seed/cell/ claims of the issued patent.
Therefore, the claimed invention is obvious over the claims of the issued patent.
Claims 20-21 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No.10, 557, 147 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant application and the issued patent recite a plant comprising an introduced polynucleotide encoding a polypeptide which comprises amino acids having any one or more of SEQ ID NO: 1, 7, 8 and 9; wherein the polypeptide does not contain a glycine at a position corresponding to amino acid residue 144 of SEQ ID NO: 1. The claims of the instant application are drawn to a process for determining whether a polypeptide confers resistance or susceptibility to one or more biotrophic fungal pathogens by obtaining a polynucleotide operably linked to a promoter, wherein the polynucleotide encodes a polypeptide having at least 80% or 90% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; wherein the biotrophic fungal pathogens is one of Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici. The claims of the issued patent are drawn to a transgenic or genetically modified plant comprising a gene encoding an Lr67 polypeptide having at least 95% or 99% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the gene has a genetic modification such that the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; said plant, wherein the Lr67 polypeptide confers upon the plant resistance to biotrophic fungal pathogens Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici; and a method of producing said plant. Issued patent claims recite “at least 95% sequence identity” to SEQ ID NO: 1, 7, 8 or 9; while the claims of instant application recite “at least 80% or 85% sequence identity “ to SEQ ID NO:1, 7, 8 or 9. Therefore, the claims of the instant application are broader in scope and encompass the claims of the issued patent.
Therefore, the claimed invention is obvious over the claims of the issued patent..
Claims 20-21 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No.10,647,992 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the instant application and the issued patent are drawn to a process for determining whether a polypeptide confers resistance or susceptibility to one or more biotrophic fungal pathogens by obtaining a polynucleotide operably linked to a promoter, wherein the polynucleotide encodes a polypeptide having at least 90% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; wherein the biotrophic fungal pathogens is one of Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici. Claims 20 and 64-74 of instant application recite “at least 80% or 85% sequence identity to SEQ ID NO: 1, 7, 8 or 9”, while claims 12-15 of the issued patent recite “at least 95% sequence identity to SEQ ID NO: 1, 7, 8 or 9”. Therefore, the claims of instant application are broader in scope and encompass the claims of the issued patent”. The claims of the instant application are also obvious to the transgenic plant/seed/cell/ claims of the issued patent.
Therefore, the claims of the instant application substantially overlap the claims of the issued patent, and are obvious over each other.
Claims 20-21, 44 and 64-74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 and 15-16 of U.S. Patent No. 12,037, 595. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of both the application and the issued patent recite a plant comprising an introduced polynucleotide encoding a polypeptide which comprises amino acids having at least 80% or 85% sequence identity to any one or more of SEQ ID NO: 1, 7, 8 and 9; wherein the polypeptide does not contain a glycine at a position corresponding to amino acid residue 144 of SEQ ID NO: 1.
The claims of the instant application are drawn to a process for determining whether a polypeptide confers resistance or susceptibility to one or more biotrophic fungal pathogens by obtaining a polynucleotide operably linked to a promoter, wherein the polynucleotide encodes a polypeptide having at least 80%, 85% or 90% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; wherein the biotrophic fungal pathogens is one of Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici. The claims of the issued patent are drawn to a transgenic or genetically modified plant comprising a gene encoding an Lr67 polypeptide having at least 90%, 95% or 99% identity to SEQ ID NO: 1, 7, 8 or 9, wherein the gene has a genetic modification such that the polypeptide does not comprise glycine at a position corresponding to amino acid number 144 of SEQ ID NO: 1; said plant, wherein the Lr67 polypeptide confers upon the plant resistance to biotrophic fungal pathogens Blumeria graminis f. sp. tritici, Fusarium graminearum, Bipolaris sorokiniana, Erysiphe graminis f. sp. tritici, Puccinia graminis f. sp. tritici, Puccinia striiformis, Puccinia hordei and Puccinia recondita f. sp. tritici; and a method of producing said plant. Therefore, the claims of the instant application and the claims of the issued patent overlap each other.
Therefore, the claimed invention is obvious over the claims of the issued patent.
Remarks
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Herrera-Foessed et al (2011) teach common wheat genotype ‘RL6077’ is believed to carry the slow rust resistance gene Lr67/Yr46 and can be used in combination with other slow rusting genes to develop leaf and stripe rust durable resistance in wheat.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/Primary Examiner, Art Unit 1662