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 on merits in the present Office action.
Claim Objections
2. Claims 1, 7, 10, 11, 15 and 20 are objected to because of the following informalities:
In claims 1 and 20, it is suggested to change the recitation “Hypogaea” to --- hypogaea--- because species starts with small cap.
In claim 7, it is suggested to insert the recitation ---of--- before “the morphological” in line 2 for the clarity of the claimed subject matter.
Claim 10 is objected for erroneously reciting another claim within the body of claim 10. See lines 3-5 of claim 10. It is suggested to delete the recitation “. The method of claim 8” or write it as independent claim.
In claim 11, it is suggested to insert the recitation ---of--- before “the morphological” in line 5 for the clarity of the claimed subject matter.
In claim 15, it is suggested to insert the recitation ---of--- before “the physiological” in line 3 of part g for the clarity of the claimed subject matter.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(a), deposit
The following is a quotation 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.
3. Claims 1-20 are rejected under 35 U.S.C. 112(a) 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 of peanut cultivar IPG 913 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. It is noted that page 45 of the specification, Applicant has indicated that deposit of seeds of peanut cultivar IPG 913 has been made. However, Applicant needs to perfect the requirements of seed deposit.
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 (25 packets of 25 seeds each) 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.
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.
In the instant case, it is also noted that that evidence of seed deposit from NCMA is missing in the records. A copy of original receipt from NCMA must also be provided to overcome this rejection.
Claim Rejections - 35 USC § 112 (Written Description)
4. Claims 5, 7, 10, 11, 14, 15, 16, and 17 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 5 is broadly drawn to progeny seeds produced from the plants obtaining from growing the seed(s) of claim 1. It is noted that table 1 describes that peanut cultivar designated ‘IPG 913’ is derived from mutagenized population of cultivar ‘AC149 followed my multiple selection for desired traits for a number of years. Furthermore, while it is understood that the domesticated peanut is an amphidiploid but the specification fails to describe clearly that allotetraploid peanut cultivar designated ‘IPG 913 is ’ is an amphidiploid. This implies that the breadth of claim encompasses species with unknown structure(s) comprising mutant and non-mutant population of seeds in the F2 seed population as encompassed by the breadth and scope of claims.
Claims 7, 11, 15 and 17 recite 5% significance limitation. However, numbers presented for various traits in Table 1 appear to be typical numbers which are subject to variation due to environmental and non-environmental factors. In light of this, one of skilled in the art can arrive at a reliable comparative conclusion on a data that is highly variable. Given the data presented in Table 1 are typical values which further raises the issue of undisclosed species with unknown structure(s) whose function cannot be reliably be predicted.
Claims 10 and 11 recite “genetically modified” due to unknown mutation(s) genome editing, RNA interference or gene silencing of unknown large number of target (genes). This implies that the breadth of claim encompasses species with unknown structure(s) comprising mutant and non-mutant population as encompassed by the breadth and scope of claims.
Claims 14 is broadly drawn to progeny peanut produced from method of claim 11. It is noted that table 1 describes that peanut cultivar designated ‘IPG 913’ is derived from mutagenized population of cultivar ‘AC149 followed my multiple selection for desired traits for a number of years. Furthermore, while it is understood that the domesticated peanut is an amphidiploid but the specification fails to describe clearly that allotetraploid peanut cultivar designated ‘IPG 913 is ’ is an amphidiploid. This implies that the breadth of claim encompasses species with unknown structure(s) comprising mutant and non-mutant population of plants in the F2 population as encompassed by the breadth and scope of claims.
It may be noted that the breadth of claims encompasses a genus having species that may not have even a first full set of chromosomes lacking full complement of alleles or loci (depending upon genetic composition of claimed allotetraploid peanut plant). Under this scenario, the breadth of claims encompasses a genus having species lacking unknown number of alleles/loci of the plant of instantly claimed peanut cultivar designated ‘913.
The written description requires that the specification clearly convey to those skilled in the art that the Applicant had possession of the claimed subject matter as of the earliest filing date, and such possession must be demonstrated for the entire scope of the claim. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010).
The only species described is a claimed peanut cultivar designated ‘913 with specific number of characteristics as described in Table 2 at pages 14-15. The specification does not describe any said progeny plants or plants produced by said peanut seed of plant of peanut cultivar designated ‘913, nor does it disclose representative examples, breeding populations, or genetic characterization to demonstrate possession of broad genus or progeny peanut plants or seeds as encompassed by the breadth and scope of claims.
Claims are not limited to a specific progeny plant or plants produced from said seed, generation, or genotype but instead encompassed any peanut plant as encompassed by the breadth and scope of claims.
The claims encompasses a large and genetically diverse population of plants, whose members may differ substantially from the disclosed peanut cultivar designated ‘913.
The Federal Circuit has repeatedly held that disclosure of a single species does not provide written description support for a broad genus absent disclosure of either (i) representative number of species or (ii) structural features common to the members of the genus such that on skill in the art can visualize or recognize the claimed genus. Ariad, 598 F .3d at 1350; Regents of the Univ. of Cal. V. Eli Lilly & Co., 119F.3d 1559, 1568-69 (Fed. Cir. 1997).
Additionally, the claims further defines the progeny plants or plants produced by said seed by functional disease resistance traits. The specification does not disclose how such resistance is predictably inherited or uniformly retained all progeny plants or plants obtained from said seed falling within the scope of these claims.
The Federal Circuit has made clear that functional claiming of a broad genus, without disclosure of a sufficient number of species or a common structural feature correlated with the function, fails the written description requirement. Ariad F .3d at 1350; AbbVie Deutschland GmbH v. Janssen Biotech, Inc., 759 F.3d 1285, 1299-1301 (Fed. Cir. 2014).
It is important to note that art of plant breeding is biologically unpredictable, and progeny plants or plants obtained from said seed can exhibit wide genetic and phenotypic variation. In the absence of disclosure of representative plants or plants obtained from said seed , or genetic determinants of the claimed traits, the specification does not demonstrate possession of the full scope of progeny plants encompassed by the claims. See In re Alonso, 545 F.3d 1015, 1021 (Fed. Cir. 2008).
Thus, Applicant’s broadly claimed genus encompasses species whose structure is unknown and hence their function is either unknown or unpredictable.
The specification fails to describe representative species of Applicant’s broadly claimed genus.
There is no description of the structure required for the recited function, and no description of the necessary and sufficient elements of functional activity of diverse structures encompassed by Applicant’s broadly claimed genus is thus unknown.
One of skill in the art would not recognize that Applicant was in possession of the necessary common attributes or features of the genus in view of the disclosed species. Since the disclosure fails to describe the common attributes that identify members of the genus, and because the genus is highly variant, peanut cultivar designated ‘913 is insufficient to describe the claimed genus.
In summary, the specification’s disclosure of a single peanut cultivar designated ‘913 does not reasonably convey to a person of ordinary skill in the art that the inventor possessed all progeny peanut cultivar designated ‘913 plants or plants obtained from seeds, and exhibiting the instantly claimed function.
Accordingly, there is lack of adequate description to inform a skilled artisan that applicant was in possession of the claimed invention at the time of filing. See Written Description guidelines published Federal Register/Vol.66, No. 4/Friday, January 5, 2001/Notices; p. 1099-1111.
Given the claim breadth and lack of guidance as discussed above, the specification does not provide written description of the genus broadly claimed. Accordingly, one skilled in the art would not have recognized Applicants to have been in possession of the claimed invention at the time of filing.
Dependent claims are also rejected because they fail to overcome the deficiency of parent claims.
Claim Rejections - 35 USC § 112(a) (Written Description-lack of Breeding History)
5. 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 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.
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 peanut cultivar designated ‘IPG 913’. So, the examiner will evaluate what is an adequate written description for a new peanut cultivar designated ‘IPG 913’. 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, it is noted that Table 1 describes the development timeline for peanut cultivar designated ‘IPG 913’ and Table 2 outlines some of the phenotypic characteristics of cultivar designated ‘IPG 913 (see pages 11-15). However, there is no accompanying breeding history in the specification. The specification fails to describe parents that were used to obtain the claimed peanut cultivar designated ‘IPG 913’. While it is understood that the domesticated peanut is an amphidiploid but the specification fails to describe clearly that allotetraploid peanut cultivar designated ‘IPG 913 is ’ is an amphidiploid. 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:
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 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 (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 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).
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.
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). 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).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant’s attention is drawn to page 11, lines 5-20 (under Development and characterization of peanut cultivar IPG 913 (experimental ’19-RS1-0913”) says:
“Peanut cultivar IPG 913 is a normal-oleic runner-type cultivar with moderate resistance to spotted wilt caused by Tomato Spotted Wilt Virus. Additionally, Peanut cultivar IPG 913 has large seed that place it in the upper range of runner-type cultivars. Peanut cultivar IPG 913 has an excellent proportion of total sound mature kernels (TSMK). Peanut cultivar IPG 913 has very high yield potential when compared to cultivars of similar maturity especially in the presence of spotted wilt and has excellent agronomic characteristics including a prominent mainstem and runner growth (prostrate) habit. Some of the selection criteria used in developing IPG 913 include the following traits: pod yield, grade, seed size, fatty acid composition, oil content, oleic acid content, disease resistance, seedling emergence, disease tolerance, TSWV resistance, herbicide tolerance, maturity, and late season plant intactness. In addition, the cultivar has been phenotypically selected upon for uniformity of plant type, pod type, and stability, as described in the following cultivar description information. Off-type plants (for either plant architecture or pod type or other phenotypic variation) have been rogued at various stages of cultivar development, and the cultivar has been increased by self-pollination with continued observation of and selection for uniformity.”
Applicant included no breeding history for peanut cultivar designated ‘IPG 913’ in the specification. No additional names for all parent(s) involved in creating hybrid for peanut cultivar designated ‘IPG 913’ is disclosed in the specification. It is also noted that that table 1 describes that peanut cultivar designated ‘IPG 913’ is derived from mutagenized population of cultivar ‘AC149 followed my multiple selection for desired traits for a number of years. However, the specification fails to describe parents and subsequent breeding history of cultivar(s) from which peanut cultivar designated ‘IPG 913’ is actually derived. This disclosure is insufficient and incomplete because it does not address all the issues set forth above.
Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete by just stating “Peanut cultivar IPG 913 has very high yield potential when compared to cultivars of similar maturity especially in the presence of spotted wilt and has excellent agronomic characteristics.” Moreover, the claims indicate Applicant has deposited seeds representative of the claimed peanut cultivar designated ‘IPG 913’. It must be noted that there is natural variation in peanut caused by genetics and environment. Additionally, the specification at page 5, lines 17-20 describes that the peanut cultivar designated ‘IPG 913’” includes “Single gene converted or conversion plant refers to plants which are developed by traditional breeding methods (e.g., backcrossing), via genetic engineering, gene-editing, or mutagenesis, wherein essentially all of the desired morphological and physiological characteristics of a line are recovered in addition to the single gene transferred into the line via the breeding technique, genetic engineering, gene-editing, or mutagenesis.” Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of peanut cultivar 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. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
Conclusion
6. Claims 1-20 are rejected. The closest prior art, Tillman et al. (US Patent NO. US 8,178,752 B1, Issued May 15, 2012) teaches a peanut variety designated UFT113 which shares some of the same traits(e.g. yellow flower color, prostrate growth habit), however, it differs at least number of days to maturity, leaflet length, leaflet width ratio, length of pod including breeding history of two varieties as breeding history of instant variety is incomplete.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VINOD KUMAR whose telephone number is (571)272-4445. The examiner can normally be reached at (571)-272-44445.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A. 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.
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/VINOD KUMAR/ Primary Examiner, Art Unit 1663
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