DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first-inventor-to-file provisions of the AIA .
Status
1. Claims 1-20 are filed on 4 June 2024 are examined herein.
Examiner’s Notes & Claim Interoperation
2. Citations to Applicant’s specification are abbreviated herein “Spec.”
3. The background regarding the state of the art, a variety is distinguished from other plants of the same species by DUS traits and/or by genetic fingerprint which is determined largely by the ancestors. In the United States, the genetic variation for commercial varieties of maize is limited with only a limited number of ancestors which may limit the potential for genetic improvement of maize. E.g. Moore (2008) Farm Industry News) ("A Shallow Gene Pool"), p. 3.
In Fehr (1987) ("Backcross Method" in Principles of Cultivar Development (Macmillan Pub. Co. (New York)) pp. 360-76), the backcross method is described as restoring 75% of the recurrent parent genome after the first backcross and restoring 87.5% of the recurrent parent genome after the second backcross (see Fig. 28-1, p. 362).
4. Table 2 recites various phenotypes using Munsell codes. Munsell codes are generally not used in parents and patent publications in phenotypic tables (usually a ‘Table 1’) for patent applications in the maize art. To allow for comparing the instant claimed maize plant the interpretation of the Munsell codes as related to the colors usually used in the maize patent art is as follows. For each, the document where the Munsell code is correlated to the color is also cited.
anther color as 2.5Y 8/4 correlates to buff. PH48DK (2021) Pioneer Plant Variety Protection Certificate, p. 6.
silk color 2.5R 4/4 correlates to indicates “dark red” (“red” also searched) NP2482 (2011) Pioneer Plant Variety Protection Certificate, p. 6.
glume color as 2.5R 7/6 correlates to pink) PHG2RDY (2018) Pioneer Plant Variety Protection Certificate
and 7.5 GY 4/4 correlates to medium green (Balko; U.S. Patent No. 5,811,645 col. 3).
Thus the glumes are taught to be pink and green.
Otherwise, based on Internet searches using the Munsell code, Root color as Munsell 5R 4/2 may correlate to a shade of red; possibly “faint” brace root anthocyanin.
Leaf color as 7.5GY 4/2 correlates to green / 7.5GY 4/6 is dark green
5. Examination of the patent application relies on the values presented in Table 2 for the claimed variety. Spec., pp. 43-47.
In particular the search focused on anther color, silk color and glume color.
Additionally, a claimed plant variety is defined by both its and its traits and genetics as represented by its breeding history together with added, e.g. transgenes.
Claim 3 is reasonably interpreted as reading on one of the recited varieties with one converted locus. (“the single locus conversion” (ll. 4-5)
It is noted that claim 7 requires the seed of claim 1. And it not drawn to starting from a plant or plant part. Starting from a claimed plant or part thereof should not raise additional issues.
Claim 19 recites the word “optionally.” Since the Markush group following that is only an ‘optional’ part of the invention, it is examined as if the Markush group was not present and/or limiting.
Copending Applications
6. Applicant should bring to the attention of the Examiner, or other Office officials 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).
Information that would be considered material to patentability includes for example, the following.
(a) The plants utilized in the breeding programs that arrived at the ancestral varieties crossed to produce the instant cultivar and their genetic relationship (e.g. grandparent lines).
(b) any progeny, siblings, half-siblings, or other closely genetically related plants that are either co-pending applications or previously published or publicly disclosed.
(c) if parental varieties that were crossed to arrive at the instantly claimed variety were developed via backcrossing this should be disclosed along with the grandparents, including which grandparent was the recurrent parent along with any publications or public disclosures of the recurrent parent and what events/loci/ transgenes/ traits were donated from the non-recurrent parent.
(d) if there is a locus converted or multiple loci converted between the deposited seeds and the seeds grown to cross to produce the hybrid seeds used for the hybrid plants grown for the trait table in the specification, then Applicant should specify which loci were converted and which traits differ when compared to plants grown from the deposited seeds,
(e) Any alternative designations, experimental names, tradenames, etc. for the instant plant, parent plants, and grandparent plants should be disclosed (e.g. synonyms).
Information Disclosure Statement
7. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. See, for example, p. 15 et seq and especially p 27 et seq.
Specification
8. The specification is objected to because of the following informalities.
On page 47, Applicant discusses the deposits. It uses a mix of future tense (line 2) and past tense with future tense (lines 10-12). It is also objected to because this section does not recite the accession numbers and their deposit dates.
It identifies the ATCC as the depository.
Applicant’s Table 2 (Spec., pp. 42-47 recites Munsell codes for colored phenotypes. This is not customary in the patent art even if it satisfies the written description requirement. Applicant is requested to amend Table 2 to add the names of the colors.
See, for example,
U.S. Patent No. 5,811,645 col. 3 (Novartis).
Wickersham U.S. Patent No. 5,859,322 col. 13 (DeKalb)
Hall, U.S. Patent No. 6,353,161 B1, col. 12 )DeKalb); and
Garing, U.S. Patent No. 7,166,778 B1 (col 13) (Monsanto)
Appropriate correction is requested.
Claim Objections
9. Claims 1, 3, and 9 are objected to because of the following informalities.
Claims 1, 3, and 9 are objected to because they include a blank line as a placeholder for the deposit number.
Appropriate correction is requested.
35 USC § 112(b)-Based Claim Rejections
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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
10. Claims 1, 3, 5, 8,9, 10, 12, 14 and 15 are rejected under 112(b) because they recite the limitation “A5000,” “A511V,” and “A513D” and/or a blank line in reference to maize plants and/or deposits. The deposit has not been perfected.
Until the deposit is perfected, the meaning of either of these limitations is uncertain and each creates ambiguity in the claims and thus renders the claims indefinite. Neither term is not well known and generally accepted in the art, and the use of either of these terms by itself does not carry art-recognized limitations defining the specific characteristics or essential characteristics that are associated with this denomination. In addition, the names appear to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of a maize plant that encompasses all of its traits except by deposit. Thus the terms in question lack a general art-accepted meaning and Applicant does not explicitly define, and cannot do so without a deposit, the terms in the specification.
Furthermore, the meaning of for example “A5000” could arbitrarily change to designate something different during the lifetime of a patent. Thus, one's ability to determine the metes and bounds of the claim would be impaired. See In re Hammack, 427 F.2d 1378, 1382; 166 USPQ 204, 208 (CCPA 1970).
Perfecting the deposit will obviate the rejection with respect to the meaning of “2935708.” Replacing the blank line with the accession number of a perfected deposit will obviate this aspect of the rejection(s).
Dependent claims are included in these rejections because none provide limitations obviating this rejection.
11. Claims 14, 15, 16 and 19 are rejected under 112(b) because they contain limitations that have improper, or no, antecedent bases.
Claim 14 recites “the single locus conversion in reference to claim 2.
Claim 15 recites “the transgene” in reference to claim 3.
For both these, the corresponding limitation does not appear in the base claim.
Examiner’s Note: It appears the dependency should be switched.
Claim 19 recites “the corn product of claim 5” but there is no such product.
Claim 16 does not correctly claim “the” part of claim 5.
Dependent claims 17, 18 and 20 are included in these rejections because none provide limitations obviating this rejection.
35 USC § 112(a) based Claim Rejections
The following is a quotation of 35 U.S.C. 112(a):
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
The Enablement Requirement of 35 USC 112(a) (Deposit)
12. 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 invention requires plants asserted by Applicant to be novel, the variety a5000.
Since this plant is essential to the claimed invention it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If the plant is not so obtainable or available, the requirements of 35 USC § 112 may be satisfied by a deposit of the seeds. A deposit of 625 seeds of each of the claimed embodiments is considered sufficient to ensure public availability.
The specification does not disclose a repeatable process to obtain the plant and thus it is not apparent if the plant is readily available to the public with respect to this application. The specification does not teach such a process. Therefore Applicant must deposit seeds to comply with 35 USC 112(a). If a deposit is made, the deposit must be accepted under the terms of the Budapest Treaty or the results or a viability test must be provided.
Further, a release statement must be made. Applicant must affirm that 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). This statement must appear above the signature of the Applicant or the Applicant's representative.
On page 62, Applicant indicates seeds will be deposited. Spec., p. 47.
All claims require a perfected deposit to be considered patentable.
The Written Description Requirement of 35 USC 112(a)
13. Claims 2, 3, 4, 13, 19 and 20, 10 and 11, 19 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 claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 2 is rejected because it is open-ended with regard to how much it is changed by adding a “transgene.” Claim 2 explicitly allows for backcrossing which can bring in additional traits. See, e.g. Fehr (op. cit.).
Claim 3 also is included because, in spite of the interpretation supra, if the single locus conversion is brought in by backcrossing, many additional traits can accompany it.
Claim 4 somewhat limits the scope by reciting possibilities but see above.
Claim 13 is included in this rejection because of the possibility of bringing in additional traits by breeding in claim 11. Further, claim 11 uses open language – “comprising.”
Claim 19 (and 20) are included because claim 19 merely reads on a processed corn product without any limitation tying it to the claimed maize variety.
Further, as discussed above, Moore teaches that the commercial maize gene pool is shallow. Moore (op. cit.).
Combining these strands of interpreting these claims, these claims encompasses a vast genus of maize plants.
Thus the rejected claims encompass a large, unknowable genus.
Therefore the claims read on the deposited seed/plants with an unlimited number of added traits or other variations. Fehr (op. cit.) teaches the during backcrossing traits from both parents are found in the progeny.
Therefore the scope of the claimed genus is certainly very large.
The rejected dependent claims do not impact the scope of the claims and are therefore included in this rejection.
Applicant does not describe a seed of said converted plant having multiple added traits. Variety a5000 is only, or will be, described and enabled by the to-be-perfected deposited seeds of the parents.
Thus these claims are "reach through" claims in which the Applicant has potentially described a starting material, the deposited seeds, but also encompasses further changes, however, they have not described the resulting product, and the genus of products that can be produced by the recited starting materials is so large that one of skill in the art is not able to envision the members of the genus. See e.g. Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004).
See also Vas-Gath Inc. v. Mahurkar, which teaches that "the purpose of the written description is for the purpose of warning an innocent purchaser, or other person using a machine, of his [or her] infringement of the patent; and at the same time, of taking from the inventor the means of practicing upon the credulity or the fears of other persons, by pretending that his invention is more than what it really is, or different from its ostensible objects, that the patentee is required to distinguish his invention in his specification.” Vas-Gath Inc. v. Mahurkar, 935 F.2d 1555, 1561, 19 U.S.P.Q.2d 1111, 1115 (Fed. Cir. 1991 ). Therefore, in the instant application, the disclosure of a claimed maize variety by deposit of its parents (to be perfected), does not provide adequate written description for the claimed genus of plants. The specification fails to describe the fully array of plants comprising the genus of transgenes, added traits and/or locus conversions encompassed by the claims. The specification fails to provide an adequate written description to support the breadth of the claims, Applicant has not demonstrated possession to one of skill in the art of the instant invention as broadly as claimed at the time of filing.
In the instant application, a practitioner would not be able to determine if any particular maize plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Dependent claims are included in this rejection because none provide further limitations obviating this rejection.
Written Description / Specification
14. 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 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 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 maize variety, the 15000 variety. Below is a consideration of what constitutes an adequate written description for such a variety. In reviewing this question of fact, the an evaluation is conducted in view of the corresponding art in the public domain. This review concludes that generally the minimum requirements for an adequate description of a new plant variety is a trait table of phenotypes and genetic information. The breeding history usually provides the genetic information. In reviewing applicant’s specification there is a phenotypic description in Table 2 (pp. 42-47).
However, there is no accompanying breeding history in the specification for the claimed variety other than the deposited seeds together with their designations, A511V and A513D. No breeding history is provided for either parent. Further, both parents appear to be unknown in the art.
,. 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:
In a different section of the MPEP, 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 (2023) https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023).
The International Union for the Protection of New Varieties of Plants (UPOV) considers breeding history and methodology part of its evaluation of essentially derived plant varieties (UPOV (2017) Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention (6 April 2017), see UPOV EDV Explanatory Paragraphs 14, 20 30 (V)) (pp. 7-11).
Recently, 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. (2011) teaches that the common assumption that elite cultivars are composed of relatively homogenous genetic pools is false. Haun et al. (2011) Plant Physiol 155:645-55, 645, left col. Segregation, recombination, DNA transposition, epigenetic processes, and spontaneous mutations are some of the reasons elite cultivar populations will maintain some degree of plant-to-plant variation (Iddd., 645, right col. and p. 646, left col.). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. Großkinsky et al.(2015) J Exp Bot 66(11):5429-40, 5430, left col., 1st full para., and right col., 2nd full para.). 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. Thus, the Office meets its 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 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 § 2411.05 states
sets forth the requirements for the content of the specification with respect to a deposited biological material. Specifically, the specification shall contain the accession number for the deposit, the date of the deposit, the name and address of the depository, and a description of the deposited biological material sufficient to specifically identify it and to permit examination. The description also 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.
Thus the breeding history aids in the resolution of patent examination as well as 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 should 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) states “[t]he specification shall contain a written description of the invention”.
The disclosure is insufficient because it does not address all the issues set forth above. The names of both the parent lines and the claimed variety are unknown in the art. It is unknown if the parents are known in the prior art under different names. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete. Moreover, Applicant intends to deposit seeds representative of the claimed cultivar.
Additionally, further to the above, Applicant classifies root color as “5r 4/2.” Spec., p. 45(top). For the purposes of examination, clarification is needed. Is this the commonly referenced ‘brace root anthocyanin” and if so, it is scored in the art as “Absent / Faint / Moderate / Dark / Very Dark.”See for example PH48DK (2021) p. 6 of PDF (top).
Balko; U.S. Patent No. 5,811,645 col. 3 (Novartis).
Wickersham U.S. Patent No. 5,859,322 col. 13 (DeKalb)
Hall, U.S. Patent No. 6,353,161 B1, col. 12 )DeKalb)
Garing, U.S. Patent No. 7,166,778 B1 (col 13) (Monsanto)
Conclusion
No claim is allowed.
Allowable Subject Matter
16. The claimed A5000 maize variety appears to be free of the prior art of record. Glumes that are pink and green are rarely, if ever, seen as a phenotype.
Somewhat close are:
(1) Delzer’s line G07-NPAF5359 (U.S. Patent No. 7,414,183 B1) – green + purple glume color (cols. 13-14).
(2) NP2222 referenced in Miller’s line G07-NPXA5489 (U.S. Patent No. 7,642,426 B1) (col. 15). Oddly, although NP2222 is the subject of a patent application (Delzer’s 2003/0140384, the glume color is not taught there (p. 4).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RUSSELL T BOGGS whose telephone number is (571)272-2805. The examiner can normally be reached Monday - Friday, 0800 to 1830 Mtn.
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/RUSSELL T BOGGS/ Examiner, Art Unit 1663