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 and are examined in the instant application.
Specification
2. The disclosure is objected to because of the following: in paragraph [00253], the Deposit Information is incomplete. Compliance with the deposit requirements may be held in abeyance until allowability is indicated.
Appropriate correction is required.
Claim Objections
3. Claims 1-20 are objected to because of the following:
In claims 1, 11 and 13, “seed” should be amended to “seeds” because more than seed is deposited.
Dependent claims are included.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
4. 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.
5. Claims 18 and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a mental process and a routine activity without significantly more. The claims recite a detecting step and optionally storing the results of said detecting on a computer readable medium. No particular method for detecting the polymorphism or the polymorphism to be detected is recited. This judicial exception is not integrated into a practical application because the detecting step is a mental determination process or data gathering step, and the additional generic computer readable medium does not add a meaningful limitation to the mental determination step because it amounts to simply implementing the mental determination step onto a computer readable medium. This is considered an insignificant extra-solution activity that is a well-understood, routine and conventional in the art. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the detecting step and storing the results of said detecting on a computer readable medium do not add significantly more to the inventive concept. In claim 19, “genetic marker analysis” is also a mental step. Thus, the claimed method is not an inventive concept. Moreover, it should be noted that the claimed method would preclude the public from the mere determination of whether or not Applicant’s invention is infringed.
Claim Rejections - 35 USC § 112(b)
6. 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.
7. 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 pre-AIA the applicant regards as the invention.
In claims 1, 11 and 13, the deposit information is missing. Cultivar 21250789 is not an art-recognized term. Absent a deposit, the metes and bounds of cultivar 21250789 cannot be determined. Compliance with the deposit requirements may be held in abeyance until allowability is indicated.
In claim 15(b), “growing a progeny plant of a subsequent generation“ should be amended to “growing a progeny plant of the subsequent generation” for proper antecedence.
Claim 18 is an incomplete method claim because it does not result in determining the genotype of the plant. No polymorphism and no genotype is recited. Additionally, the claim is directed to a method of determining the genotype of a progeny plant of the plant of claim 1. However, the recited method step does not address the progeny plant. It is also unclear what “first polymorphism” determines the genotype of the plant.
In claim 19, it is unclear where the results of the detecting are being transmitted.
Clarification and/or correction is required.
Claim Rejections - 35 USC § 112(a)
8. 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.
9. 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.
Since the seed is 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 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 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.
The specification and claims must be updated to include the deposit information. A declaration or the specification should be amended to provide statements (a)-(e) above. Proof of an accepted deposit is requested.
10. 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 written description requirement.
35 USC 112 (a) states “The specification shall contain a written description of the invention” (emphasis added). In evaluating written description, the threshold question is: what is an adequate written description? This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new soybean cultivar (21250789). Thus, the examiner evaluates what is an adequate written description for a new soybean cultivar. In reviewing this question of fact, the examiner analyzes how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety are a trait table and genetic information (via a breeding history). In the Specification, there is a phenotypic description of cultivar 21250789 in Table 1 and the names of two parents used to produce the claimed cultivar [0069]. No genotypic or phenotypic traits for the parents are disclosed. The parents are not indicated as being publicly available. In a separate filed communication, Applicant discloses additional names for one parent of the claimed cultivar. However, such communication is not part of the Specification and cannot provide the written description required to be in the Specification. Without the disclosure in said filed communication, one skilled in the art would not have known that the 16EN311013-26 parent is publicly available, is known by other names and is a prior art cultivar. Because the specification lacks a complete breeding history, and that breeding history is part of the minimum description of a plant variety, Applicant has not fulfilled the requirement of 35 USC 112(a) to provide adequate written description of the claimed cultivar in the Specification. The Office’s reasonable basis for challenging the adequacy of written description is supported by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
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” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
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, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). 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. As seen 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. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 645, left column). 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 5430, left column, 1st full paragraph, and right column, 2nd full paragraph). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a complete breeding history is necessary written description. With this information, the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in Applicant’s disclosure a description of the invention defined by the claims (MPEP 2163.04). It should be noted that the citations above are not referenced for legal authority. The legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a complete breeding history is necessary to provide adequate description of a plant variety.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 2163(I) states “The description must be sufficient to permit verification that the deposited biological material is in fact that disclosed. Once the patent issues, the description must be sufficient to aid in the resolution of questions of infringement." Id. at 34,880.)” (Quoting the Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864 (August 22, 1989) at 34,880).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. A specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have yet to be 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, including all the names of the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
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 must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar 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 one 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 as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is 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). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. 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).
Accordingly, the additional names for the 16EN311013-26 parent of the claimed variety as disclosed in the separately filed communication must be included in the Specification. If the second parent has additional names, they must be included in the Specification as well.
Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. Paragraph [0072] states that “There is natural variation in soybean caused by genetics and environment.” Additionally, paragraph [0195] states the term “soybean plant” includes any single gene conversions of that cultivar, and said plant has essentially all the morphological and physiological characteristics of the cultivar. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of soybean plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed cultivar, including all names for the parents and for the claimed cultivar, are material for patentability. An adequate written description is essential to preclude the issuance of a patent that would otherwise issue due to Applicant’s omission of critical information from the Specification.
Correction and/or clarification is required.
11. Claim 10 is 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 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, at the time the application was filed, had possession of the claimed invention.
Claim 10 is directed to a plant produced by introducing a transgene conferring a desired trait into a plant of cultivar 21250789, wherein the plant comprises the transgene and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 21250789. Paragraph [0252] states that “a” and “an” are to be construed to cover both the single and the plural. Paragraph [0076] states that cultivar 21250789 may contain up to 15 transgenes. The term “otherwise” in the claim is understood by the Office to be the morphological and physiological characteristics that remain after the introduction of up to 15 transgenes by any method, including by multiple outcrossings with undisclosed plants. Applicant has no working example of a plant comprising transgenes and its morphological and physiological characteristics. It is unpredictable what morphological and physiological characteristics of cultivar 21250789 are retained, lost or altered upon the introduction of transgene(s). The claimed plant lacks adequate written description because it is not known what methods were utilized to introduce the transgenes. Thus, the claimed plant further comprising a transgene lacks adequate written description. It is suggested Applicant amends the claim to indicate that the transgene is introduced by backcrossing or transformation.
Accordingly, one skilled in the art would not have recognized Applicant was in possession of the claimed invention at the time of filing. See Written Description Guidelines, Revision 1, March 25, 2008, published online at http://www.uspto.gov/web/menu/written/pdf.
Claim Rejections - 35 USC §§ 102 and 103
12. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
13. 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.
14. The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
15. Claims 1-20 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Mason, J. (US Pub. No. 20230091171, filed September 22, 2021 (A)).
Paragraph [0072] states that “There is natural variation in soybean caused by genetics and environment.” Additionally, paragraph [0195] states the term “soybean plant” includes any single gene conversions of that cultivar, and said plant has essentially all the morphological and physiological characteristics of the cultivar. Thus, the claimed plant and seed are not required to have all the morphological and physiological characteristics of cultivar 21250789 as disclosed in the specification.
Mason teaches soybean cultivar 09080611 which shares at least 14 morphological and physiological characteristics with the claimed cultivar, including seed coat color, seed coat luster, cotyledon color, leaflet shape, growth habit, flower color, pubescence color, pod wall color, maturity group, lodging score, plant height, seed size, event DAS-44406-6 for 2,4-D herbicide resistance and rhg 1 allele for soybean cyst nematode resistance (+/- 10% std dev.). Prior art Mason further teaches all the claimed products and methods with regard to cultivar 09080611 (claims).
Accordingly, the claimed invention is anticipated by, or in the alternative, is obvious in view of the prior art. See In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985), which teaches that a product-by-process claim may be properly rejected over prior art teaching the same product produced by a different process, if the process of making the product fails to distinguish the two products. Since the Patent Office does not have the facilities to examine and compare the plant of Applicant’s with that of the prior art, the burden of proof is upon the Applicant to show an unobvious distinction between the claimed plant and the plant of the prior art. See In re Best, 562F.2d 1252, 195 USPQ 430 (CCPA 1977).
Conclusion
16. No claim is allowed.
17. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHUONG T BUI whose telephone number is (571)272-0793. The examiner can normally be reached M-F 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad Abraham can be reached on 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PHUONG T BUI/Primary Examiner, Art Unit 1663