DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election
Applicant’s election of Group VIII, Claim 35, in the response received on July 10, 2025, is acknowledged. After further consideration, the Examiner finds that all claims are obvious over one another, and there is not a burden for examining them all together. For this reason, ALL CLAIMS ARE REJOINED. The restriction requirement mailed on April 11, 2025, is withdrawn. Claims 14-35 are pending and are examined in this Office Action.
Specification
The disclosure is objected to because of the following informalities: on page 81, there is a table in portrait orientation, but the words in the table are upside down.
Appropriate correction is requested.
Claim Objections
Claims 18 and 26 are objected to because of the following informalities:
In claim 18, Applicant recites “the nucleic acid molecule homozygous”, and this is grammatically incorrect. Applicant is advised to replace this with - - the nucleic acid molecule is in the plant in homozygous form - - .
In claim 26, the recitation is scientifically inaccurate. The recited tolerance is not obtainable from the deposited seeds, but a nucleic acid conferring the tolerance is obtainable. In addition “deposition NCIMB _____” is incorrect. Applicant is advised to rewrite the claims as follows: - - The plant according to claim 25, wherein the tolerance to glyphosate is conferred by a nucleic acid comprised in seeds deposited under NCIMB Accession No. 41158 or NCIMB Accession No. 41159 and/or wherein the tolerance to an ALS-inhibitor herbicide is conferred by a nucleic acid comprised in seeds deposited under NCIMB Accession No. 41705. - -
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 29, 32, and 33 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 29 recites the limitation "the mutated acetolactate synthase gene" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The claims from which claim 29 depends do not have any recitation of a mutated acetolactate synthase gene.
Claim 32 recites the limitation "the fluorescent dye" in line 1. There is insufficient antecedent basis for this limitation in the claim because the claim from which claim 32 depends (claim 30) does not recite any fluorescent dye.
Claim 33 recites the limitation "the plants from (i)" in line 4. There is insufficient antecedent basis for this limitation in the claim because link (i) only recites a seed, it does not recite “plants”. In addition the last line recites “wherein the method counteracts an infestation of the cultivated plants with Cercospora”, and it is unclear what the metes and bounds of this “wherein” clause are.
It is unclear what “counteracts” means. Does this mean all of the cultivated plants have no disease symptoms? Does this mean a portion of the cultivated plants have no disease symptoms? Does this mean the symptoms are less severe or less frequent compared to plants exposed to the same infestation but lacking the claimed nucleic acid?
It is unclear what is meant by “infestation”. Does this mean there is a detectable amount of the pathogen in the population of cultivated plants? Does this mean there is a detectable amount of the pathogen in the soil or the growth media? Furthermore, the claim does not include any required material or active method step to arrive at this infestation. Does the planting in part (i) require planting in infected soil or infected growth media? Does this mean the method requires inoculating the soil or growth medium with Cercospora? It appears that there is at least one active method step missing from the claim.
Inadequate Scope of Enablement
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.
Claim 33 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method involving cultivating plants comprising a nucleic acid encoding a protein with at least 95% identity to SEQ ID NO: 3 wherein the plant expresses the protein which confers resistance to Cercospora beticola, the specification does not reasonably provide enablement for cultivating descendants of plants grown from seeds comprising a nucleic acid conferring resistance to Cercospora beticola. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The claim encompasses cultivation of descendants of plants grown from seeds comprising a nucleic acid conferring resistance to Cercospora beticola and the descendants may or may not have retained the nucleic acid encoding a protein that confers resistance to Cercospora beticola. When a diploid plant produces seeds, if the plant is heterozygous for a particular nucleic acid, then 25% of the progeny will be homozygous for the nucleic acid, 50% will be heterozygous for the nucleic acid, and 25% will have lost the nucleic acid entirely. For this reason, there is no reason that a given descendant would necessarily comprise the nucleic acid that confers the resistance. The claim is only enabled for cultivation of a plant that comprises the nucleic acid to confer the resistance.
Inadequate 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 14-35 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. All dependent claims are included in these rejections unless they include a limitation that overcomes the deficiencies of the parent claim.
The claims are broadly drawn to a plant of the subspecies Beta vulgaris subsp. vulgaris (sugar beet) comprising a nucleic acid molecule encoding a polypeptide that is able to confer resistance to Cercospora beticola in a plant in which the polypeptide is expressed, wherein the nucleic acid molecule comprises a nucleotide sequence which is selected from the group consisting of:
a nucleotide sequence that comprises the DNA sequence according to SEQ ID NO: 2;
a nucleotide sequence that comprising the DNA sequence according to SEQ ID NO: 1 or SEQ ID NO: 53;
a nucleotide sequence that is at least 95% identical to the DNA sequence according to SEQ ID NO: 1 or SEQ ID NO: 2.
The claims are also drawn to seeds of said plant and methods of making and using said plants or seeds.
Applicants describe a Cercospora resistance-conferring gene from Beta vulgaris subsp. maritima that comprises SEQ ID NO: 1, the cDNA sequence for this gene comprises SEQ ID NO: 2, and the protein encoded by this gene and cDNA is SEQ ID NO: 3 (Spec 66). This resistance gene was the result of an extensive breeding program that began with open pollination between 150 resistant plants followed by crossing and selection, and eventually genetic mapping and sequencing (Id. 85). The locus harboring the resistance gene had highly repetitive structure with tandem repeats (Id.). The resistance gene of SEQ ID NO: 1 was verified by transforming the cDNA into a susceptible beet plant (Id. 79-80). The protein encoded by this resistance gene has two deletions and two insertions as well as multiple mis-matches relative to SEQ ID NO: 6 which is an allele that does not confer resistance (Id. Figure 1). Applicants describe differences between their new resistance allele and all of the alleles of the starting varieties and assert that this could be an indication of significant genetic restructuring at this locus that took place during the breeding process (Id. 90).
Applicants do not describe any polypeptides encoded by nucleic acids with at least 95% identity to SEQ ID NOs: 1 or 2 that are able to confer resistance to Cercospora when expressed in a beet plant.
The Federal Circuit has previously clarified the application of the written description requirement to inventions in the field of biotechnology. The court stated that, “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).
Applicants fail to describe a representative number of polypeptides encoded by polynucleotides with at least 95% identity to SEQ ID NOs: 1 or 2 that are able to confer resistance to Cercospora when expressed in a beet plant. Applicants only describe nucleic acids encoding SEQ ID NO: 3 and expression of a protein comprising SEQ ID NO: 3 that are able to confer resistance to Cercospora when expressed in a beet plant. Furthermore, Applicants fail to describe structural features common to members of the claimed genus of polypeptides capable of conferring resistance to Cercospora when expressed in a beet plant. Hence, Applicants fail to meet either prong of the two-prong test set forth by Eli Lilly. Furthermore, given the lack of description of the necessary elements essential for a polypeptide to be able to confer resistance to Cercospora when expressed in a beet plant, it remains unclear what features identify polypeptides capable of such activity. Since the genus of polypeptides encoded by nucleic acids with at least 95% identity to SEQ ID NOs: 1 or 2 has not been described by specific structural features, the specification fails to provide an adequate written description to support the breadth of the claims.
SEQ ID NO: 1 is 3720 nucleotides in length and SEQ ID NO: 2 is 2652 nucleotides in length therefore, the recitation of having at least 95% identity to these sequences allows up to 186 and 132 substitutions, respectively; therefore, polynucleotides with at least 95% identity encompass 4186 (~9.6 x 10111 ) and 4132 (2.96 x 1079 ) molecules, respectively. If each of the 186 substitutions in SEQ ID NO: 1 were to change a codon such that it resulted in an amino acid change, then the resulting polypeptide would have only 79% identity to SEQ ID NO: 3, and similarly if the 132 substitutions in SEQ ID NO:2 were to change a codon such that it resulted in an amino acid change, then the resulting polypeptide would have only 85% identity to SEQ ID NO: 3. Many of these proteins would not have the ability to confer resistance to Cercospora when expressed in a beet plant, and the vast majority of which were not in the possession of Applicant at the time of filing.
Accordingly, the specification fails to provide an adequate written description to support the genus of polypeptides encoded by polynucleotides with at least 95% identity to SEQ ID NOs: 1 or 2 that are able to confer resistance to Cercospora when expressed in a beet plant as set forth in the claims.
Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 17 and 19 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 17 requires the resistance conferred to the sugar beet plant to be dominant. The fact that the resistance is dominant is an inherent feature of the polypeptide of SEQ ID NO: 3 (Spec 1, lines 21-23). For this reason the resistance required in the parent claim is already dominant and claim 17 does not further limit the parent claim.
Claim 19 recites “wherein the plant comprises the nucleic acid molecule as an introgression”. This is a product-by-process limitation, and the only weight given to the process in this type of claim is the structures or properties that are conferred by the process. In the instant claim, the process of introgression does not confer any structure or property to the claim plant unless the parent plant that is the donor of the introgressed locus is defined. In the instant case, the nucleic acid molecule could be comprised anywhere in the entire genome of the donor parent plant, and the process of introgressing into a recipient parent plant would not add any structure or property that would narrow the scope of the plants encompassed by claim 19 compared to the scope of plants encompassed by claim 14.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Nonstatutory Double Patenting over US Patent No. 10,767,171 B1
Claims 14-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 10,767,171 B1. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-12 of the ‘171 patent are directed to pelleted seed of the sugar beet plant claimed in instant claim 14. Instant claims 23 is directed to a seed of the same sugar beet plant that has been “primed”. It is routine in the art for beet seeds to be primed first and then pelleted, and therefore, the seed of the instant claims 22 and 23 are intermediate products that would be used to arrive at the pelleted seeds in the ‘171 claims; in fact the ‘171 claim 7 requires the seed to be primed before or during pelleting. The plant of claim 14 is obvious over the ‘171 claims because it is understood in the art that seeds would be harvested from the plants.
Instant claim 15 requires the plant to be a hybrid plant; the ‘171 claim 8 requires the seed to be from a hybrid plant.
Instant claim 16 is directed to double haploid version of the claimed plant; and the Examiner takes official notice that making double haploid versions of plants with desired traits is a common practice in plant breeding, and it would have been obvious to make a double haploid plant from the parent plant that grew the seeds claimed in the ‘171 patent.
Instant claim 17 requires the resistance to be dominant; the ‘171 claim 9 requires dominant resistance.
Instant claim 18 requires the nucleic acid molecule to be homozygous, and the Examiner takes official notice that self-pollinating a plant comprising a desired trait to arrive at a homozygous version is routine in the art of plant breeding.
Instant claim 19 is indistinguishable from instant claim 15, and therefore it is obvious for the same reason.
Instant claim 20 requires that the plant comprising the nucleic acid is a variety. It is known in the art that a “variety” is a subset of a particular plant species that has distinct, uniform, and stable traits that distinguish this subset from other plants within the same species. Plant breeders often use varieties with desirable traits for their breeding programs to arrive at commercially successful plant products. Therefore, using a plant “variety” to grow the pelleted seed claimed in the ‘171 patent is an obvious variation.
Instant claim 21 is directed to a storage organ, and a seed is a storage organ.
Instant claims 24-29 require the claimed plant to comprise specific herbicide resistance genes all of which are well known and commonly used, therefore, these are obvious variations over the prior art and the ‘171 claims.
Instant claims 30-32 are directed to methods for identifying a sugar beet plant comprising the claimed nucleic acid using routine method steps that well-known and common. One of ordinary skill in the art would have appreciated that these methods are obvious ways to identify beet plants that will produce the beet seeds claimed in the ‘171 patent.
Instant claim 33 is directed to a method involving planting and cultivating the claimed plants, and this is an obvious use of the pelleted seeds of the ‘171 patent.
Instant claims 34-35 are directed to methods for making the claimed plants, and they use routine method steps to introduce or introgress the required nucleic acid into a sugar beet. One of ordinary skill in the art would have appreciated that these methods are obvious ways to arrive at the beet seeds claimed in the ‘171 patent.
Nonstatutory Double Patenting over US Patent No. 11,597,944 B2
Claims 14-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,597,944 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-22 of the ‘944 patent are directed to sugar beet plants that are a subgenus that completely falls within the genus of sugar beet plants claimed in instant claim 14. The difference in scope is due to the instant claims opening up the scope of the claims by allowing the plants to comprise nucleic acids with as little as 95% identity to instant SEQ ID NOs: 1 or 2, and while some of these plants will comprise a nucleic acid that encodes a polypeptide with at least 95% identity to SEQ ID NO: 3, some will have as little as 79% identity to SEQ ID NO: 3 which is a much broader scope.
With regard to claims 15-35, the claim language is nearly identical to the claim language in claims 2-22 of the ‘944 patent.
Summary
No claim is allowed.
Examiner’s Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHY KINGDON whose telephone number is (571)272-8784. The examiner can normally be reached on M-F 9:00 - 5:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo "Joe" Zhou can be reached on (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CATHY KINGDON
Primary Examiner
Art Unit 1662
/CATHY KINGDON/Primary Examiner, Art Unit 1662