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. The Office acknowledges the receipt of Applicant’s restriction election filed August 10, 2026. Applicant elects Group I, directed to corn inbred line SHY-6S15-2102XW. As no traverse is presented, this election is treated as an election without traverse. Claims 1-24 are pending. Claims 4, 6 and 8 are withdrawn. Claims 1-3, 5, 7 and 9-24, to the extent of corn line SHY-6S15-2102XW, are examined.
The restriction is made FINAL.
Specification
2. The disclosure is objected to for the following reasons:
The status of parent Application No. 17/752544 should be updated in paragraph [0001] of the specification.
The title is not descriptive of the claimed invention. It is suggested the title be amended to –CORN LINE SHY-6S15-2102XW--.
The abstract of the disclosure is objected to because the claims are directed to corn line SHY-6S15-2102XW. However, the abstract recites corn hybrid SVSK4540. See MPEP § 608.01 (b).
Appropriate correction is required.
Claim Objections
3. Claims 1-3, 5, 7 and 9-24 are objected to because of the following:
In claims 1, 14, 15 and 17, “seed” should be amended to “seeds” because more than one seed is deposited.
Claim 14 recites the non-elected inventions of corn hybrid SVSK4540.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
4. 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.
5. Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 14 is directed to a corn plant produced by introducing a transgene conferring a trait into a plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW, wherein the plant comprises the trait and otherwise comprises all of the physiological and morphological characteristics of corn line SHY-6S15-2102XW. However, a plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW encompasses an F1 hybrid plant, which does not have all the physiological and morphological characteristics of corn line SHY-6S15-2102XW. Paragraph [0212] defines a transgene as “A genetic locus comprising a sequence which has been introduced into the genome of a corn plant by transformation or site-specific modification.” Thus, it is unclear how an F1 hybrid plant, which does not have all the physiological and morphological characteristics of corn line SHY-6S15-2102XW, upon transformation or site-specific modification, would have all the physiological and morphological characteristics of corn line SHY-6S15-2102XW in addition to the added trait. Does Applicant intend for claim 13 to depend from claim 3?
Correction and/or clarification is required.
Claim Rejections - 35 USC § 112(a)
6. 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.
7. Claims 1-24 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 corn line (SHY-6S15-2102XW). So, the examiner will evaluate what is an adequate written description for a new corn line. In reviewing this question of fact, the examiner analyzes how plant lines/varieties are evaluated in the public domain. The review concludes 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 reviewing Applicant’s specification, there is a phenotypic description of line SHY-6S15-2102XW in Table 3. However, there is no accompanying breeding history in the specification for the claimed line. Because the specification lacks a 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 a written description 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 McGowen, a trait table is insufficient to differentiate varieties by itself.
It has been long established that intraline heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite lines 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 line 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 line. (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 Applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Importantly, it should be noted that the citations above are not referenced for legal authority. The legal authority relied 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 for the 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) further 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 variations of 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 a complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents of the claimed line, 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. 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.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant line. 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 line and all other potential names for the claimed line. 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 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 line 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 line). 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 Information Disclosure Statement 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).
In the instant application, the claims indicate that seeds representative of corn line SHY-6S15-2102XW are deposited. The claims are not directed to the deposited seeds or plants grown therefrom. Neither the Specification nor the claims indicates that the claimed seed is genetically identical to the deposited seeds. When two inbred parents are crossed, one skilled in the art would reasonably expect to obtain a population of progeny plants that shares most of the phenotypic characteristics but are not necessarily genetically identical due to naturally-occurring genetic and environmental factors. Thus, the recitation of “SHY-6S15-2102XW” in the claims is understood by the Office to encompass a genus of seeds/plants that are not are not genotypically identical. Additionally, paragraph [0027] states “A small percentage of variants can occur within commercially acceptable limits for almost any characteristic during the course of repeated multiplication.” The bottom of Table 3 states “These are typical values. Values may vary due to environment. Values that are substantially equivalent are within the scope of the invention.” Further, paragraph [0035] states that an occasional variant trait might arise during backcrossing, introduction of a transgene, or application of a genetic engineering technique. Applicant is claiming a genus of plants that are genotypically and phenotypically different from the deposited material and from the morphological and physiological characteristics disclosed in Table 3. As no other information is disclosed, and many corn varieties share the same morphological and physiological characteristics, the breeding history is essential to distinguish the claimed genus of plants from other plants. In a separate Transmittal Letter filed in divisional Application No. 17/752544 on March 2, 2023, Applicant discloses that corn line SHY-6S15-2102XW was developed from crossing homozygous proprietary lines SEY084-SESM1709 and SHY084-5055 (US Pat. No. 9277693). The Transmittal Letter does not indicate whether these parent lines are known by other names, whether SEY084-SESM1709 is publicly available and whether siblings of the claimed line are filed in another patent document. Moreover, a Transmittal Letter is not part of the Specification and cannot provide the written description required by the statute to be in the Specification. Thus, the breeding history for the claimed line as disclosed in the Specification is incomplete.
It should be noted that the Patent Owner is not making the genetic sequence (genotype) of the claimed line available. No genetic marker information is disclosed to distinguish the genus of claimed plants from other plant when Applicant is in the best position to do so. Polymorphisms exist within the genus of plants claimed. Applicant’s failure to provide this information is evidence that it is not practical to do a marker analysis to distinguish Applicant’s genus of claimed plants from others.
Given the facts that Applicant is claiming a genus of seeds/plants that are genotypically and phenotypically different from the deposited material, that many corn varieties share the same morphological and physiological characteristics, that the Specification is silent with regard to the breeding history of the claimed line, that no distinguishing genotypic information is disclosed to distinguish Applicant’s claimed genus from other varieties, and that the state of the art as evidenced by the above cited documents indicates that the minimum description for a plant line is the combination of the phenotype and genotype (breeding history) for the claimed line, the Office has determined that the claimed line, as disclosed in the Specification, lacks adequate written description.
Correction is required.
8. Claims 7, 9, 17 and 18 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 7 and 9 encompass an F1 progeny embryo and seed cell of a corn plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW, which is the same as an F2 progeny of line SHY-6S15-2102XW. The genome of a corn plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW encompasses an F1 hybrid progeny, which is heterologous at every locus. When said F1 hybrid progeny is crossed with an unknown parent, it is unpredictable what genetic material its F2 progenies would inherit. The specification does not disclose a representative number of F2 progenies of the F1 hybrid progeny to allow one skilled in the art to predict the genetic makeup or physiological and morphological characteristics of the claimed F2 progenies. No identifying characteristics are set forth for the F2 progenies. There are insufficient relevant identifying characteristics to allow one skilled in the art to predictably determine the genomic structure or morphological and physiological characteristics of the claimed F2 progenies, absent further guidance. Accordingly, the claimed plant part and cells of the F1 hybrid progeny lack adequate written description.
With regard to claims 17 and 18, a corn plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW further comprising a single locus conversion lacks adequate written description for the following reasons. The genome of a corn plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW encompasses an F1 hybrid progeny, which is heterologous at every locus. When said F1 hybrid is outcrossed with a genetically different plant to introduce a single locus conversion, it is highly unpredictable what combination of dominant and recessive alleles of the F1 hybrid is present in its F2 progeny plant, and what morphological and physiological characteristics are present in the F2 progeny plant. Even if the F2 progeny plant is backcrossed to its F1 hybrid parent, due to the heterozygous genome of the F1 hybrid parent, the backcrossed progeny would not regain most of the morphological and physiological characteristics of its F1 hybrid parent. Thus, the morphological and physiological characteristics of a plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW further comprising a single locus conversion cannot be adequately described. Applicant has no working example of a plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW further comprising a single locus conversion. Thus, the claimed plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW further comprising a single locus conversion lacks adequate written description.
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.
9. Claims 1-24 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 claims contain 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 line SHY-6S15-2102XW 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 does not indicate that all restrictions upon availability to the public will be irrevocably removed upon granting of the patent. Evidence of an accepted deposit is requested.
10. Claim 14 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 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.
Enablement factors to consider include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. In re Wands, 858 F.2d 731, 737 (Fed. Cir. 1988).
Claim 14 is directed to a corn plant produced by introducing a transgene conferring a trait into a plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW, wherein the plant comprises the trait and otherwise comprises all of the physiological and morphological characteristics of corn line SHY-6S15-2102XW. However, a plant comprising at least a first set of the chromosomes of corn line SHY-6S15-2102XW encompasses an F1 hybrid plant, which does not have all the physiological and morphological characteristics of corn line SHY-6S15-2102XW. Paragraph [0212] defines a transgene as “A genetic locus comprising a sequence which has been introduced into the genome of a corn plant by transformation or site-specific modification.” Thus, it is unclear how an F1 hybrid plant, which does not have all the physiological and morphological characteristics of corn line SHY-6S15-2102XW, upon transformation or site-specific modification, would have all the physiological and morphological characteristics of corn line SHY-6S15-2102XW in addition to the added trait. The genome of an F1 hybrid is heterologous at every locus. No morphological and physiological characteristics of said F1 hybrid are disclosed prior to the introduction of the transgene. As shown in the specification, hybrid SVSK4540 has significantly different morphological and physiological characteristics from line SHY-6S15-2102XW. Yet somehow, upon transformation or site-specific modification, a plant comprising at least one set of chromosomes of corn line SHY-6S15-2102XW, which is much broader in scope than hybrid SVSK4540, said plant regains all of the morphological and physiological characteristics of corn line SHY-6S15-2102XW in addition to the trait conferred by the transgene. Applicant has no working example of a plant produced by the claimed method. The state of the prior art does not teach the introduction of a transgene to an F1 hybrid plant to produce a plant having otherwise all the morphological and physiological characteristics of one of its parents. Given these difficulties, notwithstanding a relatively high level of ordinary skill of those in the art, the amount of experimentation would likely be extensive and undue. Weighing all the Wands factors based on the totality of the record as discussed above, the Office determines that it would require undue experimentation for a person of ordinary skill in the art to make and use the invention as claimed.
Conclusion
11. No claim is allowed. The Office interprets a “plant part” to encompass at least one regenerable cell. The Office does not interpret any of the claimed products to encompass plant material obtained by crossing an F1 hybrid progeny of SHY-6S15-2102XW with a genetically different plant. Otherwise, rejections under 35 USC 112(a) may apply.
12. The claims are free of the prior art. The closest prior art teaches corn line SHY-084-5055 which shares at least 15 physiological and morphological characteristics with Applicant's SHY-6S15-2102XW, including (+/- 10% std. dev. or same Munsell color group) corn type, heat units from emergence to 50% of plants in silk, heat units from emergence to 50% of plants in pollen, average number of ears per stalk, anthocyanin of brace roots, number of leaves above top ear, leaf color, number of primary lateral branches, branch angle from central spike, number of kernel rows appearance, ear taper and cob diameter (US Pat. No. 9265211, Table 3, (Applicant’s IDS)). However, at least their 10% to 90% pollen shed days, 50% silk to optimum edible quality days and heat units, plant height, ear height, length of top ear internode, average number of tillers, leaf angle, leaf sheath pubescence, marginal waves, longitudinal creases, tassel length, husk tightness, shank length and ear weight differ.
13. 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.
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/PHUONG T BUI/Primary Examiner, Art Unit 1663
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