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 .
Priority
Acknowledgment is made of applicant’s claim for benefit under 35 U.S.C. 119(e).
Status of the Claims
Claims 1-26 are pending.
Claims 1-26 are examined herein.
Specification
The disclosure is objected to because of the following informalities:
The Specification on Page 62 contains an incomplete deposit accession number.
Appropriate correction is required.
Claim Objections
Claims 1, 9, 14 and 21 are objected to because of the following informalities:
Claims 1, 9, 14 and 21 recite incomplete deposit numbers. Appropriate correction is required.
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 1-26 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 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.
The Federal Circuit has clarified the written description requirement. The court stated that a written description of an invention "requires a precise definition, such as by structure, formula, [or] chemical name, of the claimed subject matter sufficient to distinguish it from other materials". University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568; 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). The court also concluded that "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not description of that material". Id. Further, the court held that to adequately describe a claimed genus, Patent Owner must describe a representative number of the 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.
Applicant claims a soybean plant of cultivar GER00056038.
Applicant describes cultivar GER00056038 with respect to physiological and morphological characteristics in Table 1 and in comparison to other varieties (Table 2).
Applicant does not describe any breeding history of the instantly claimed GER00056038 cultivar, which is reasonably required to describe the recited plants and seeds and methods of use thereof. The parental germplasm is important to understanding the claimed plant.
The requirement of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding.
With regard to Plant Patents, MPEP § 1605 states that the description should include
a complete detailed description of the plant and the characteristics thereof that distinguish the same over related known varieties . . . The specification should also include the origin or parentage.
Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to "determine if development is sufficient to consider the variety new. USDA (2023) Applying for a Plant Variety Certificate of Protection https://www.ams.usda.gov/services/pvpo/application-help/apply, accessed 1 May 2023).
Additionally, the International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV (2017) Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, n 14 & n. 30).
While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. Historically, the USPTO has considered breeding history information when determining the patentability of a new plant variety (See Ex Parte C (USPQ 2d 1492 (1992) and Ex Parte McGowen, Board Decision in Application 14/996,093, 2020). In both of these cases, there were many differences cited by the applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
Moreover, a specification devoid of a breeding history hampers the public's ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history aside from one parent, is not known to the public, the public could only rely on the phenotypes of the claimed plant for assessing potential infringement.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. The assumption that elite cultivars are composed of relatively homogenous genetic pools is false. Haun et al. (2011) Plant Physiol. 155:645-55; see p. 645, l col.
Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (Id., p. 645, R col., para. 2, to 646, L col., para. 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. Großkinsky et al. (2015) J. Exp. Bot. 66:5429-40 (see p. 5430 L col., para. 2, and R col., para. 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant should amend the specification to identify any and all other potential names for all parental lines utilized in the development of the instant variety.
For example, if Applicant's breeding history uses proprietary line names, Applicant should notate in the specification all other names of the proprietary lines, especially publicly disclosed or patented line information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If either of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line(s) as well (i.e., grandparents).
Applicant is also reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants, which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
Thus these claims are "reach through" claims in which the Applicant has described a starting material and at least one method step, however, they have not described the resulting product, and the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. See e.g. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004).
See also Vas-Gath Inc. v. Mahurkar, which teaches that "the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his [or her] 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 its ostensible objects, that the patentee is required to distinguish his invention in his specification.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991).
Hence, Applicant has not, in fact, described the claimed invention within the full scope of the claims, and the specification fails to provide an adequate written description of the claimed invention.
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.
Claims 1-26 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.
The claims are directed to seeds and plants of soybean cultivar GER00056038, to plants and plant parts derived from said variety, and to the methods of using said variety. The invention appears to employ novel plants. Since the plant 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 the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability. The specification does not disclose a repeatable process to obtain the plant and it is not apparent if the plant is readily available to the public. It is noted that Applicant provides a statement in the Specification on page 62 that appears to indicate that Applicant has made or will make a deposit of 625 seeds under the terms of the Budapest Treaty.
At this time no deposit number or date of deposit has been provided by Applicant.
However, even if a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent must be made. No such statement is included by Applicant. A statement indiciating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent will satisfy this requirement.
The Deposit statement must indicate if the deposit is made under the Budapest Treaty or that it otherwise complies with the requirements of 37 CFR § 1.808(a)(2). Further, pursuant to MPEP 2409, the statement should indicate that the deposit has been accepted.
(a) If a deposit is made under the terms of the Budapest Treaty, then a statement, affidavit or declaration by Applicants, or a statement by an attorney of record over his or her signature and registration number, or someone empowered to make such a statement, stating that the instant invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein.
(b) If a 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 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, 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:
(i) during the pendency of this application, access to the invention will be afforded to the Commissioner upon request;
(ii) 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);
(iii) 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;
(iv) a test of the viability of the biological material at the time of deposit (see 37 CFR § 1.807); and,
(v) the deposit will be replaced if it should ever become inviable.
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 1-26 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 pre-AIA the applicant regards as the invention.
Claims 1, 9, 14 and 21 recite a variety name – soybean cultivar GER00056038 – without reciting any deposit accession numbers associated with the name. Because “GER00056038” is not a term otherwise known in the art, one of ordinary skill in the art would not be apprised of what the recited variety was and as such the metes and bounds of the claims are unclear. Claims that depend from a claim rejected as indefinite without further clarification are rejected as a function of their dependency.
Conclusion
No claims are allowed.
The claims appear to be free of the prior art. The closest prior art is Wiley US 10757897 B1, which discloses Soybean Variety OT11129279. Although Variety OT11129279 and the instantly claimed cultivar share many traits, they differ in several characteristics including flower color and hilum color.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES A LOGSDON whose telephone number is (571)270-0282. The examiner can normally be reached M-F 8:30 - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou can be reached at (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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/CHARLES LOGSDON/Primary Examiner, Art Unit 1662