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/Restrictions
Applicant’s election of group I, claims 1-2, 15-16, 36 and 40 and the species of SEQ ID NO: 10 in the reply filed on 06/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Upon further consideration, claims 17-23 and 34-35 have been rejoined with the elected claims 1-2, 15-16, 36, and 40. The species election requirement between the SEQ ID NO: 1-10 is withdrawn.
Claims 1-12, 15-27, 29-31, 33-36, and 40-46 are pending.
Claims 3-12, 24-27, 29-31, 33, 39, 42-46 are withdrawn from consideration as being directed to the non-elected invention.
Claims 1-2, 15-23, 34-36, 40-41 and SEQ ID NO:1- 10 are examined in this office action.
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).
Claim Objections
At claim 40, it is suggested that “commodity product of claim 36” be replaced with ---nonliving or nonregenerable sugar beet plant or a commodity product of claim 36---, for proper dependency----.
Claim Rejections - 35 USC § 112
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 1-2, 15-23, 34-36 and 40-41 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.
Claims 1 and 36 are indefinite because the group listed is not written in proper Markush format of “selected from the group consisting of A, B, C, and D”. The claim requires SEQ ID NO: 1-9 or 10 and a complete complement of any of the foregoing. It is unclear if the complement is a part of the Markush grouping. Further, the grouping is improper because the sequences of SEQ ID NO: 1-10 are described in the specification on pages 15-16 as follows:
SEQ ID NO: 1 is a 5’ junction region and corresponds to nucleotide positions 986-1015 of SEQ ID NO: 10.
SEQ ID NO: 2 is a 3’ junction region and corresponds to nucleotide positions 12708-12737 of SEQ ID NO: 10.
SEQ ID NO: 3 is a 5’ junction region and corresponds to nucleotide positions 971-1030 of SEQ ID NO: 10.
SEQ ID NO: 4 is a 3’ junction region and corresponds to nucleotide positions 12693-12752 of SEQ ID NO: 10.
SEQ ID NO: 5 is a 5’ junction region and corresponds to nucleotide positions 951-1050 of SEQ ID NO: 10.
SEQ ID NO: 6 is a 3’ junction region and corresponds to nucleotide positions 12673-12772 of SEQ ID NO: 10.
SEQ ID NO: 7 is a 1050 nucleotide sequence representing the 5’ genomic flank region of the sugar beet genomic DNA with 50 nucleotides of the integrated transgene insert and corresponds to nucleotide positions 1-1050 of SEQ ID NO: 10.
SEQ ID NO: 8 is a 1050 nucleotide sequence representing 50 nucleotides of the integrated transgene insert and the 3’ genomic flank region of the sugar beet genomic DNA and corresponds to nucleotide positions 12673-13722 of SEQ ID NO: 10.
SEQ ID NO: 9 is a 11722-nucleotide sequence corresponding to the transgene insert of sugar beet event Bv_CSM63713, and corresponds to nucleotide positions 1001-12722 of SEQ ID NO:10.
SEQ ID NO:10 is a 13722-nucleotide sequence corresponding to the contig nucleotide sequence of the 5' sugar beet genomic DNA sequence (SEQ ID NO:11), the transgene insert in event Bv_CSM63713 (SEQ ID NO:9), and the 3' sugar beet genomic DNA sequence (SEQ IDNO:12). Therefore, the grouping is improper.
Clarification is required to more clearly define the metes and bounds of the claims.
Claim 35 is indefinite because the method of claim 34 does not necessarily produce an inbred or hybrid sugar beet plant or seed.
Claim 36 is indefinite by depending upon the non-elected claim 27. It is suggested that “the DNA construct of claim 27; or c )” be replaced with ----; or---, to obviate the rejection.
Claim 40 is indefinite in the recitation of the exemplary claim language “such as” as the intended scope of the claim is unclear. It is unclear as to whether the narrower terms within the brackets is a limitation.
Dependent claims are included in the rejection.
Claim Rejections - 35 USC § 112
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.
Claim 2 is 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 2, part a), does not further limit parent claim 1 because the source of the DNA does not further limit the function or structure of the recombinant DNA, given that the recombinant DNA is inherently derived from sugar beet event BV_CSM63713. 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.
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 2, 17-23, 34-36 and 40-41 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The claims require sugar beet plant event Bv_CSM63713, a representative sample of seed comprising the event having been deposited as ATCC Accession No. PTA-127098.
Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is readily available to the public. It is noted that Applicant has deposited seed comprising sugar beet event Bv_CSM63713 at ATCC. However, there is no statement regarding the acceptance of the deposited seed in the specification that seeds have been deposited and accepted.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then a statement, an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating that the seeds has been deposited and accepted, and will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. A minimum deposit of 625 seeds is considered sufficient in the ordinary case to assure availability through the period for which a deposit must be maintained.
If the deposit has not been made under the Budapest Treaty, then in order to certify that the deposit, meets the requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, an affidavit or declaration, or by someone empowered to make the same, or by a statement by an attorney of record over his or her signature and registration number showing that:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent in accordance with 37 CFR 1.808(a)(2):;
(c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer;
(d) the viability of the biological material at the time of deposit will be tested (see 37 CFR 1.807); and
(e) the deposit will be replaced if it should ever become inviable.
For each deposit made pursuant to these regulations, the specification shall be amended to contain (see 37 CFR 1.809):
The accession number for the deposit;
The date of the deposit;
A description of the deposited biological material sufficient to specifically identify it and to permit examination; and
The name and address of the depository.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Scope of Enablement Rejection
Claims 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 transgenic sugar beet plant comprising the event Bv_CSM63713, does not reasonably provide enablement for using sugar beet plants comprising a recombinant DNA molecule of SEQ ID NO: 1-10 or a complete complement thereof or a sequence having at least 90%, 91%, 92%, 93% or 94% to SEQ ID NO: 9 or 10, or a recombinant DNA that does not comprise the full insert sequence of event BV_CSM63713. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention commensurate in scope with these claims.
Claims 1-2 are drawn to recombinant DNA comprising SEQ ID NO: 1-10 or having a sequence that is at least 90%, 91%, 92%, 93% or 94% to SEQ ID NO: 9 or 10; wherein the recombinant DNA: is derived from or is comprised in a sugar beet plant, seed, plant part, plant cell, progeny plant, or commodity product comprising sugar beet event Bv_CSM63713; or is formed by the insertion of a heterologous nucleic acid molecule into the genomic DNA of any sugar beet plant or sugar beet cell; or comprises an amplicon diagnostic for the presence of sugar beet event Bv_CSM63713. Claims 15-16 are drawn to a sugar beet plant, seed, plant part or plant cell comprising said recombinant DNA; said sugar beet plant, seed, plant part or plant cell expresses and is tolerant to at least one herbicide; or is a progeny of any generation of any generation of a sugar beet plant comprising event Bv_CSM63713 or a plant, seed, plant part or plant cell derived thereof. Claims 36 and 40 are drawn to a non-living, nonregenerable sugar beet or commodity comprises whole or processed seeds, nonviable seeds, processed plant parts, processed plant tissues, dehydrated plant tissues, dehydrated plant parts, frozen plant tissues, frozen plant parts, plant parts processed for animal feed, fiber, pulp, pulp pellets, pulp shreds, tailings, juice, syrup, molasses, extract, raffinate, betaine, separator molasses solubles (SMS), or any other food for human consumption, viable seeds, viable plant parts (such as roots and leaves), or viable plant cells.
In contrast, the specification provides guidance for a transgenic sugar beet plant, seed or plant part comprising event Bv_CSM63713, a representative sample of seed comprising the event having been deposited as ATCC Accession No. PTA-127098, and a method of using said transgenic sugar beet plant, seed or part thereof in breeding methods.
The specification does not provide guidance for transgenic sugar been plant , seed or plant part that expresses or have herbicide tolerance as a result of having a recombinant DNA comprises SEQ ID NO: 1-8 because:
SEQ ID NO: 1 is a 5’ junction region and corresponds to nucleotide positions 986-1015 of SEQ ID NO: 10.
SEQ ID NO: 2 is a 3’ junction region and corresponds to nucleotide positions 12708-12737 of SEQ ID NO: 10.
SEQ ID NO: 3 is a 5’ junction region and corresponds to nucleotide positions 971-1030 of SEQ ID NO: 10.
SEQ ID NO: 4 is a 3’ junction region and corresponds to nucleotide positions 12693-12752 of SEQ ID NO: 10.
SEQ ID NO: 5 is a 5’ junction region and corresponds to nucleotide positions 951-1050 of SEQ ID NO: 10.
SEQ ID NO: 6 is a 3’ junction region and corresponds to nucleotide positions 12673-12772 of SEQ ID NO: 10.
SEQ ID NO: 7 is a 1050 nucleotide sequence representing the 5’ genomic flank region of the sugar beet genomic DNA with 50 nucleotides of the integrated transgene insert and corresponds to nucleotide positions 1-1050 of SEQ ID NO: 10.
SEQ ID NO: 8 is a 1050 nucleotide sequence representing 50 nucleotides of the integrated transgene insert and the 3’ genomic flank region of the sugar beet genomic DNA and corresponds to nucleotide positions 12673-13722 of SEQ ID NO: 10.
The specification also does not provide guidance for the use of a polynucleotide with 90% sequence identity to the 11722-bp nucleotide sequence of SEQ ID NO: 9, or with 90% sequence identity to the 13722-bp nucleotide sequence of SEQ ID NO: 10. These sequences encompass sequences with nucleotide changes in the coding regions sequences of every transgene insert in SEQ ID NO: 9 and 10. Further, the specification does not provide guidance for where and how to modify SEQ ID NO: 9 or 10, to obtain sequences having 90% identity to SEQ ID NO: 9 or 10 that retain the desired function. The specification does not teach a single species of sugar beet plant, seed or plant part or commodity comprising the recombinant DNA of claim 1. Therefore, the quantity of experimentation necessary to practice the claimed invention is excessive and undue since the specification discloses no direction or guidance for how to modify the polynucleotide sequences as broadly recited in the claims, and since SEQ ID NO: 1-8 are 3’ or 5’ sequences and does not have the complete transgene insert sequence of the sugar beet event Bv_CSM63713.
Given the lack of guidance in the instant specification, the breadth of the claims, and unpredictability inherent in transgene modifications, the nature of the invention which is transgenic sugar beet event, one would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
In Genentech Inc. v. Novo Nordisk AIS (42 USPQ2d 1001 at p. 1005) The CAFC stated "Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not workable...While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention...[W]hen there is no disclosure of any specific starting material or of any of the conditions under which a process can be carried out, undue experimentation is required ....". See also, In re Fischer, 166 USPQ 19 24 (CCPA 1970) where the court required that the scope of the claims must bear a reasonable correlation with the scope of the enablement; and Ex Parte Maizel, 27 USPQ2d 1662 (BPAI 1992) where the board found that there was no reasonable correlation between the scope of exclusive right desired by Appellant and the scope of enablement set forth in the patent application.
Therefore, for all the reasons discussed above, the specification does not enable the broad scope of the claims without undue experimentation.
Conclusion
No claim is allowed.
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
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