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 .
Election/Restrictions
Applicant’s election of the species of LS2147685 in the reply filed on 07/28/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
The requirement is still deemed proper and is made FINAL.
Claims 1-20 are pending.
Claims 1-20 drawn to ES2145580, ES2145584, ES2145638, ES2145730, LS2147588, LS2147814, LS2147831 or LS2147978 are withdrawn from consideration as being directed to the non-elected invention.
Claims 1-20, drawn to soybean variety LS2147685, are examined.
Copending Applications
Applicants must bring to the attention of the Examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications, which are "material to patentability" of the application in question. MPEP 2001.06(b). See Dayco Products Inc. v. Total Containment Inc., 66 USPQ2d 1801 (CA FC 2003).
Objections
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The title should refer to the elected soybean variety LS2147685.
The specification is objected to for missing complete deposit accession information of the claimed soybean variety LS2147685. Appropriate correction is required.
IMPROPER MARKUSH GROUPING REJECTION
Claims 1-20 are rejected under the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-722 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. and Int.1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial feature and/or common use that flows from the substantial structural feature and/or common use that flows from the substantial structural feature for the following reasons:
Claims 1, 7, 6, 11, 13-15 and 18 recite a list of Markush grouping of 9 soybean varieties having distinct morphological and physiological characteristics resulted from distinct and unique genomes. Because the claims encompass different soybean varieties which are genetically, biochemically, morphologically, and physiologically divergent; the members of the improper Markush grouping do not share a substantial feature and common use that follows from the substantial structural feature. See Tables 1, 3, 5, 7, 9, 11, 13, 15 and 17 showing the morphological and physiological differences between the soybean varieties listed in the claims.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or groupings of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature.
This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 USC 134 and 37 CFR 41.31.
Claim Rejections - 35 USC § 112
The following is a quotation of the second paragraph of 35 U.S.C. 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 pre-AIA the applicant regards as the invention.
The claims are indefinite in the recitation of blank spaces “___” and because the name “LS2147685” does not clearly identify the claimed soybean variety, seed and plant and does not set forth the metes and bounds of the claimed invention. Since the name of “LS2147685” is not known in the art, the use of said name does not carry art recognized limitation as to the specific characteristics or essential characteristics that are associated with denomination. In addition, the name appears to be arbitrarily assigned, and the specific characteristics associated therewith could be modified, as there is no written description of the soybean plant/seed that encompasses all of its traits.
Amending claim 1 to recite complete accession information for soybean variety LS2147685 would overcome the rejection to claims 1-17. Note, claim 18 does not require deposit information. The rejection to claims 18-20 can be obviated by amending claim 18 to recite complete deposit accession information for the soybean variety.
Claim 15 is indefinite in the recitation of “essentially all of the physiological and morphological characteristics” of soybean variety LS2147685 (as the elected species) as it is not clearly defined in the specification. It is unclear which characteristics should be recovered for the claimed soybean plant to meet “essentially all” characteristics. Therefore, the matters and bounds of the claim are unclear.
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 1-20 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 claims require seed and plant of soybean variety LS2147685.
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, a deposit thereof may satisfy the requirements of 35 U.S.C. 112. 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. It is noted that Applicant intends to deposit seed of soybean variety LS2147685. However, there is no affirmative statement in the specification that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent.
If the deposit of these seeds is made under the terms of the Budapest Treaty, then a statement, 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 has been deposited and accepted, and 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 requirements set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, Applicant may provide assurance of compliance by statement, an 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:
(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 in accordance with 37 CFR 1.808(a)(2);
(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 effective 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.
Compliance with this requirement may be held in abeyance until the application is otherwise in condition for an allowance.
Written Description Rejection, Missing Breeding History
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. 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.
35 USC 112 (a) states that "The specification shall contain a written description of the invention". 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 lettuce cultivar variety Lucia. So, the examiner will evaluate what is an adequate written description for a new soybean variety LS2147685. In reviewing this question of fact, the examiner analyzed 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 has a trait table and genetic information (via a breeding history). In reviewing applicant's specification there is a phenotypic description as is seen in Tables 11-12. However,
There is no accompanying breeding history in the specification. Because the specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office's reasonable basis for challenging the adequacy of written description is informed by a review of the following:
1. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes "the origin or parentage".
2. 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 5/01/2023, (U)).
3. The International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology as 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)).
4. 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 prior art could not have been possible.
5. 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. Haun et al. (Plant Physiology,
Feb. 2011, Vol. 155, pp. 645-655) 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. (2015), Vol. 66, No. 11, pp. 5429-5440, 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 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 an applicant's disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not 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 breeding history is necessary to the adequate description of a plant.
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).
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.
Moreover, 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 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, including 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). Applicants 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.
Applicants are reminded that they have a duty to disclose information material to patentability. Applicants 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 are 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).
35 USC 112(a) clearly states "The specification (emphasis added) shall contain a written description of the invention". In the instant application, Applicant included no breeding history for soybean variety LS2147685 in the specification. A specification devoid of a complete breeding history hampers the public's ability to fully resolve questions of infringement.
Claims 3-4 and 15 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.
Claims 3-4 are drawn to a genus of soybean plants/seed obtained by transforming soybean variety LS2147685 by any method. The specification describes plant/seed of soybean variety, sample of seed to be deposited and perfected, having the morphological and physiological characteristics as listed on Table 11. The specification also fails to describe a representative species of plant produced by the method of claim 14, wherein the plant or selfed progeny thereof comprises a single locus conversion and otherwise comprises “essentially” all of the physiological and morphological characteristics of the soybean variety LS2147685. A substantial variation in phenotype and genotype is expected among the claimed genus of plants/seed.
Neither the specification nor the prior teaches the correlation between genome structure and some of the traits of soybean variety LS2147685, except for the soybean variety LS2147685 itself. There is no conserved structure for the genus of the claimed soybean plant with a multiple of different transformation processes that retains the genome structure of soybean variety LS2147685, or “essentially” all of the physiological and morphological characteristics of the soybean variety LS2147685.
The Federal Circuit 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 material". University of California v. Eli Lilly and Co., 43 USPQ2d 1398 (Fed. Cir. 1997). The court also stated, "naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of is not a description of that material". Id. Further, the court stated that to adequately describe a claimed genus, Applicant 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 members of the genus". Id.
Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612.
Therefore, the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that Applicant was in possession of the invention as broadly claimed at the time of filing.
Conclusion
The closest prior art is soybean variety 01052058 of Gilsinger, Jessel (US 9, 338, 986 B2), pending Applicant’s response to the attached Rule 105 Information Request.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEDINA AHMED IBRAHIM whose telephone number is (571)272-0797. The examiner can normally be reached Monday-Friday, 9:00 - 6:00.
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, BRATISLAV STANKOVIC can be reached at 571-270-0305. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MEDINA AHMED. IBRAHIM
Primary Examiner
Art Unit 1662
/MEDINA A IBRAHIM/ Primary Examiner, Art Unit 1662
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