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 .
DETAILED ACTION
1. Claims 1-20 are pending in the instant application and are examined in this Office Action.
Claim Interpretation
2. In claims 1, the recitation “A seed of hybrid canola variety " is interpreted as a seed to produce hybrid canola variety 16GG0316C plant rather than a seed produced by hybrid canola variety 16GG0316C plant. In claim 2, the recitation “at least one cell of hybrid canola variety 16GG0316C” is interpreted as a somatic cell of hybrid canola variety 16GG0316C. In claim 17, the recitation “at least one F1 hybrid canola variety 16GG0316C cell” is interpreted as a somatic cell of converted F1 hybrid canola variety 16GG0316C. Applicants are required to traverse such interpretation if Applicants disagree on such interpretation.
Specification
3. The specification is objected to for missing deposit information on page 48.
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.
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.
4. Claims 1-20 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 pre-AIA the applicant regards as the invention.
In claim 5, the recitation “wherein representative seed of varieties G00012 and G00555 have been deposited under NCMA Accession Number XXXXX and ATCC Accession Number PTA-XXXX, respectively” renders the claim indefinite. It is unclear the deposited seeds are representative to canola variety GH00012 and G00573MC, respectively, or canola variety G00012 and G00555 further comprising a single locus conversion. Further, for converted plant, the specification, on pg 7, paragraph [0049], defines “Locus conversion” as follows:
A locus conversion refers to plants within a variety that have been modified in a manner that retains the overall genetics of the variety and further comprises one or more loci with a specific desired trait. Such as male sterility, insect control, disease control or herbicide tolerance. Examples of single locus conversions include mutant genes, transgenes, gene-edited alleles/genes, and native traits finely mapped to a single locus. One or more locus conversion traits may be introduced into a single canola variety.
It is unclear what is considered as overall genetics being maintained and it is also unclear whether the claimed hybrid seed otherwise comprises all the physiological and morphological characteristics of canola variety 16GG0316C when grown under the same environmental conditions. The metes and bounds are not clear.
Claims 1, 5 and 12 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite in its recitation “NCMA Accession Number XXXXX and ATCC Accession Number PTA-XXXX, respectively” because the NCMA Accession Numbers are missing.
Claims 1, 5 and 12 are rejected under 35 U.S.C. 112, second paragraph, as being indefinite in the recitation maize variety “G00012 and G00555” because the recitation does not clearly identify the claimed maize cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “G00012 and G00555” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the maize plant that encompasses all of its traits. This rejection can be obviated by amending the claims to recite the NCMA deposit number.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Deposit
5. Claims 1-21 are rejected under 35 U.S.C. 112, first paragraph, as containing 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. Since the seeds of G00012 and G00555 are essential to the claimed invention, it must be obtainable by a reproducible 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 reproducible 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. If the deposit of the seed is made under the terms of the Budapest Treaty, then an affidavit or declaration by the Applicant, or a statement by an attorney of record over his or her signature and registration number, stating the seed have been deposited under the Budapest Treaty and that the seed 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 2500 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 criteria set forth in 37 CFR 1.801-1.809, Applicant may provide assurance of compliance by an affidavit or declaration, 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;
(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 enforceable 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 unviable.
Applicant has NOT indicated that Applicant intends to deposit the seeds at the NCMA in accordance with 37 CFR 1.801-1.809. Accordingly, Applicant needs to provide a signed statement indicating compliance with 37 CFR 1.801-1.809, the NCMA Accession No. and evidence of deposit to overcome this rejection. Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Written Description
Claims 5-20 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 drawn to a seed or plant of hybrid canola variety further comprising either a transgene or a single locus conversion, and methods of making and using said seed or plant. At page 47 of the specification, it states that the articles “a” and “an” are not restrictive regarding the number of instances of the element or component. And at page 20 of the specification, it states that a locus conversion of 16GG0316C may contain at least 1, 2, 3, 4 or 5 locus conversions, and fewer than 15, 10, 9, 8, 7 or 6 locus conversions, and can be made in as little as two backcrosses. Therefore, the claims encompass plants that differ genotypically and phenotypically from hybrid canola 16GG0316C by either having an unrestricted number of transgenes, or in multiple unspecified locus conversions.
it is well known in the art that plant transformations often—if not always—introduce unwanted and uncertain alterations to the genetic, physiological and/or morphological characteristics. For example, Latham et al. (Journal of Biomedicine and Biotechnology 2006:1-7 (2006)) teaches that mutations found at transgene insertion sites include deletions and rearrangements of host chromosomal DNA and introduction of superfluous DNA. Insertion sites introduced using Agrobacterium tumefaciens tend to have simpler structures but can be associated with extensive chromosomal rearrangements, while those of particle bombardment appear invariably to be associated with deletion and extensive scrambling of inserted and chromosomal DNA. Ancillary procedures associated with plant transformation, including tissue culture and infection with A. tumefaciens, can also introduce mutations. These genome-wide mutations can number from hundreds to many thousands per diploid genome (Abstract). Furthermore, Latham teaches that both insertion-site and genome-wide mutations may result in transgenic plants with unexpected traits. Despite the supposed precision of genetic engineering, it is common knowledge that large numbers of individual transgenic plants must be produced in order to obtain one or a few plants that express the desired trait in an otherwise normal plant (p. 4, left column, paragraph 4). Therefore, the claimed canola plants further comprising a transgene or a single locus conversion encompass plants having broad, undescribed physiological and morphological characteristics, that may not resemble the canola variety 16GG0316C.
The Federal Circuit has 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. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus”. Id.
See MPEP Section 2163, where it is taught that the claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art-recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.
Also, see Vas-Cath Inc. v. Mahurkar 1991 (CAFC) 19 USPQ2d 1111, 1115, which teaches that the purpose of written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his infringement of the patent and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from ostensible objects, that the patentee is required to distinguish his invention in his specification.
Therefore, given the lack of written description in the specification with regard to the structural and physical characteristics of the claimed compositions, one skilled in the art would not have been in possession of the genus claimed at the time this application was filed.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of US Patent No. While the claims are not identical (those of this application refer to canola cultivar 16GG0316C whilst those of US Patent No. 11,793,136 refer to canola cultivar 17GG1817G), the claims are not patentably distinct from each other because the referenced canola cultivars originated from the same parental cross (G00012 and G00555) and have nearly identical phenotypic characteristics (see Table 1 for each application). Based on the current record, there is no meaningful difference between the subject matter of these applications (e.g., the claimed canola plants and claimed uses thereof).
Summary
Claims 1-20 are rejected.
However, claims 1-20 are free of the prior art for the failure of the prior art to teach or fairly suggest Canola variety 16GG0316C.
The closest prior art is US Patent Application Publication 2016/0353698 which teach canola 46M34 having many similar phenotype to those of Canola variety 16GG0316C. However, two varieties have distinct seed content and genetic background.
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/LI ZHENG/Primary Examiner, Art Unit 1662