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 1-12,18-20 and 22-26 are pending and examined on the merits.
Specification
2. The specification is objected to for missing deposit information on page 50.
Claim Objections
3. Claims 1, 11, 19 and 24 are objected to because ATCC Accession Number is missing.
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 1-12,18-20 and 22-26 are rejected (claims 1, 2, 8 and 15 are rejected and, therefore, claims 3-7, 9-14 and 16-20 which depend therefrom are also 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, 11, 19 and 24 refer to “ATCC Accession Number X1”. While it is acknowledged that Applicant will/has made a deposit of Camelina sativa plant CMN2207 seed in compliance with 37 C.F.R. § 1.801-1.809 (pages 50-51 of the specification), because the Accession Number information is incomplete within the claims, it is unclear what Camelina sativa plant CMN2207 refers to. The metes and bounds are not clear.
The claims which are dependent on claim 1 are also rejected.
5. Claims 1-12,18-20 and 22-26 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 instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including search of the prior art, nor does it provide enough description to be sufficient to aid in the resolution of questions of infringement.
Claims 1-12,18-20 and 22-26 are drawn to a Camelina sativa plant CMN2207, representative sample of seed having been deposited under ATCC Accession Number X1 or a Camelina sativa plant wherein said Camelina sativa plant 1) flowers and reaches maturity earlier than a control winter Camelina accession , 2) flowers and reaches maturity later than a control spring Camelina accession , 3) can survive in a freezing environment after transitioning to a floral meristem and 4) is able to flower absent vernalization, and wherein representative sample of seed having been deposited under ATCC Accession Number X1.
The specification teaches Camelina sativa plant CMN2207, wherein representative seed of said Camelina sativa plant CMN2207 will be deposited at ATCC and with physiological and morphological characteristics shown in Figures 1-17.
First, for Camelina sativa plant CMN2207, physiological and morphological characteristics shown in Figures 1-17, such as Julian days for camelina to reach 50% plot flowering or seed yield, are dramatically affected by environment as evidenced by Applicant’s own data shown in those Figures. Still further, the specification fails to explicitly describe Camelina sativa plant CMN2207 as inbreed or hybrid. Without additional physiological and morphological characteristics described, it is impossible to compare instant Camelina sativa plant with ones in prior art. Although a deposit will likely to be provided, deposit alone do not satisfy the written description requirement.
Still further, claims 24-26 read on a genus of Camelina sativa plant 1) flowers and reaches maturity earlier than a control winter Camelina accession, 2) flowers and reaches maturity later than a control spring Camelina accession, 3) can survive in a freezing environment after transitioning to a floral meristem and 4) is able to flower absent vernalization, and wherein representative sample of seed having been deposited under ATCC Accession Number X1.
The Applicants do not describe any other species in claimed genus except for Camelina sativa plant CMN2207 itself. The only structure correlated with a Camelina sativa plant having all of the physiological and morphological characteristics of the Camelina sativa plant CMN2207 or a transformed plant comprising the transgene and otherwise comprising all of the phenotypic characteristics of Camelina sativa plant CMN2207 is the genome of Camelina sativa plant CMN2207. The specification fails to teach conserved structure responsible for 1) flowers and reaches maturity earlier than a control winter Camelina accession, 2) flowers and reaches maturity later than a control spring Camelina accession, 3) can survive in a freezing environment after transitioning to a floral meristem and 4) is able to flower absent vernalization, except for the genome of Camelina sativa plant CMN2207.
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).
Applicants fail to describe a representative number of Camelina sativa plants falling within the scope of the claimed genus. Applicants only describe a single species of the genus which is Camelina sativa plant CMN2207 wherein representative sample of seed having been deposited under ATCC Accession Number X1. The deposited seeds do not represent the whole genus of Camelina sativa plants as claimed in claims 24-26.
Furthermore, Applicants fail to describe structural features common to members of the claimed genus of Camelina sativa plants. 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 claimed genus of Camelina sativa plants as claimed in claims 24-26, it remains unclear what features identify a member of claimed genus. Since said genus has not been described by specific structural features, the specification fails to provide an adequate written description to support the breath of the claims.
Deposit
6. Claims 1-12,18-20 and 22-26 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.
It is noted that Applicant has deposited seeds for Camelina sativa plant CMN2207 at the ATCC (specification, pages 50-51). However, Applicant' s statement that the deposit was accepted under both standards (i.e. the Budapest Treaty and 1.801-1.809), does not satisfy the requirements under the Budapest Treaty or 1.801-1.809 for a statement which indicates that upon issuance (of a patent) all restrictions on the public availability to the public of the deposit will be irrevocably removed and additionally under 1.801-1.809 guidance, an indication of viability from the depository. Nonetheless, in the absence of the required statements, Applicant' s deposit statement requires clarification.
In order to certify that the deposit, meets the requirements set forth under the terms of the Budapest Treaty, 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 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.
In order to certify that the deposit, meets the requirements 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 inviable.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
7. Claim(s) 23 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Fernando Guillen-portal (US Patent Application Publication No. 2012/0124692).
Claim 23 is drawn to a part of F1 Camelina sativa plant of claim 12.
Given “a part” of plant includes seed, instant claim reads on a F2 seed. Given that the parent to generate F1 and F2 seeds is unknown, instant claims reads on any Camelina sativa seed.
Fernando Guillen-portal teaches a Camelina sativa seed (claim 1). Therefore, the reference teaches all the limitation set forth by the claim.
Conclusion
Claims 1-12,18-20 and 22-26 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LI ZHENG whose telephone number is (571)272-8031. The examiner can normally be reached Monday-Friday (9-5).
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/LI ZHENG/Primary Examiner, Art Unit 1662
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