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 .
Claims 1-20 are pending and examined on their merit.
Specification
The disclosure is objected to because of the following informalities:
The specification is objected for lacking a deposit date and a deposit number: on page 52, the deposit date and a deposit number are missing. It is assumed that Applicant will provide the appropriate information in response to the instant Office action.
Appropriate correction is required.
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.
Claims 18-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claim 18 is directed to a method. The claims recite series of steps and, therefore, are directed to a process. Therefore, the claims fall within at least one statutory category. (Step 1: YES).
The method comprises the step of detecting a polymorphism in a sample of nucleic acids from said plant or part thereof. Under the directive of Broadest Reasonable Interpretation, this step falls into the “mental process” grouping of abstract ideas because the selecting process can be practically performed in the human mind, i.e., by observing and comparing data. The claims further implies a law of nature because it silently invokes the naturally occurring relationship between a plant’s genotype (polymorphisms in the nucleic acids) and phenotype. Therefore, the claims are directed to the judicial exception because the (implied) limitations of isolating and assaying NA are mere data gathering. The limitation is insignificant extra-solution activity. (Step 2A: Yes)
This judicial exception is not integrated into a practical application because “Analyzing DNA to provide sequence information or to detect allelic variants” has been recognized by the courts as a routine laboratory technique. See MPEP 2106.05(d), subsection II. This limitation therefore remains insignificant extra-solution activity and does not amount to significantly more. Even when considered in combination, these additional elements represent mere instructions to apply an exception and insignificant extra-solution activity, which cannot provide an inventive concept. (Step 2B: No.)
Therefore, claim 18 does not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The analysis now turns to the dependent claim 19.
Claim 19 further recites that the step of detecting comprises DNA sequencing or genetic marker analysis. As discussed above, the active step of DNA sequencing or genetic marker analysis is recognized as routine laboratory technique. See MPEP 2106.05(d), subsection II. This limitation therefore remains insignificant extra-solution activity and does not amount to significantly more. Even when considered in combination, these additional elements represent mere instructions to apply an exception and insignificant extra-solution activity, which cannot provide an inventive concept. (Step 2B: No.)
Therefore, claims 18 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
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 1-20 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, 11, and 13 are indefinite in their recitation "NCMA Accession _____" because the NCMA Accession Number is missing. Therefore, the metes and bounds of the claims are not clear. Amending the claims to recite the NCMA accession number would overcome the rejection.
Claims 1, 6, 10, 11, 13, 16, and 17, are being indefinite in their recitation “soybean cultivar 21120238” because the recitation does not clearly identify the claimed plant cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “soybean cultivar 21120238” 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 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.
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.
ENABLEMENT
Claims 1-20 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 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 invention appears to employ the seed of novel plants. 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, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. 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.
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. In the instant case, the Specification has not explicitly stated that subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
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 ATCC 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.
Conclusion
No claims are allowed.
Claims 1-20 are free of the prior art. The closest prior art is Eby (US 11744211 B2, filed in 2020) which teaches Soybean cultivar 92310017. The prior art soybean cultivar shares many physiological and physiological characteristics with the instantly claimed, such as seed coat color and luster; colors of cotyledon, flower, pubescence, hilum, and pod wall (Table 1); and the presence of transgenic events MON89788, MON87708, and A5547-127. However, the prior art variety differs from the instantly claimed in at least the Relative Maturity, parental lineage, and breeding history.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WEIHUA FAN whose telephone number is (571)270-0398. The examiner can normally be reached Monday-Friday, 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at (571) 270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663