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 1-26 as filed on 3 June 2024 are examined herein.
Examiner’s Notes & Claim Interoperation
2. Citations to Applicant’s specification are abbreviated herein “Spec.”
Examination of the patent application relies on the values presented in Table 1 for the variety 2935708. Spec., pp. 8-9.
In particular the search focused on white flowers, brown pod walls, black hilum color, light tawny pubescence color, and a maturity rating of 3.7.
3. 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.
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.
In the United States, the genetic variation for commercial varieties of soybean is limited with only a limited number of ancestors which may limit the potential for genetic improvement of soybean . 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. Claim 19 is drawn to a plant. None of the other claims are drawn to just a plant. It is a plant produced by the method of claim 18, but claim 18 merely requires editing the genome. It is not required to produce any meaningful change and indeed, the plant of claim 19 is identical to the plant encompassed by claim 1, but claim 1 also reads on seeds.
On the other hand, Applicant’s explicit definition of ‘plant’ in paragraph 0039 includes all forms of plant-derived parts. The plain language of the pending claims are interpreted to override the definition in paragraph 0039.
If Applicant disagrees with this interpretation, Applicant should clearly distinguish the claimed subject matter in, for example, the composition claims 2 and 19.
Claim 22 is interpreted, since it depends from claim 21, as if the “oil” embodiment of claim 22 is distinguishable from soybean oil from a different soybean plant.
Copending Applications
5. 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).
Specification
6. The disclosure is objected to because of the following informalities.
The disclosure is objected to because the deposit information on page 62 does not provide the deposit number; instead a blank line is present as a placeholder for accession number. Furthermore, the specification fails to provide the date of the deposit date.
Appropriate correction is requested.
The word and context of “irrevocably” in line 8 of paragraph 0263 is noted.
Claim Objections
7. Claims 1, 9, 21 and 24-26 are objected to because of the following informalities.
These claims 1, 9, and 21 are objected to because they include a blank line as a placeholder for the deposit number.
Claim 9 is objected to because it recites the limitation “at least one nucleic acid sequence” is being added to the claimed soybean plant. A “sequence” however is merely information. Applicant appears to mean that a molecule such as a gene, such as a transgene, is being added to the genome, but the phrasing makes it uncertain as to Applicant’s intent. Further, does it encompass use of, e.g. CRISPR, to change a single nucleotide in the genome.
Applicant is advised that should claim 23 be found allowable, claims 24-26 will be objected to under 37 CFR 1.75 as being substantial duplicates thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). All four claims are drawn to “a seed” which, event though they are in potentially different seeds bags, are identical to each other as far as the seed itself is concerned.
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 1-26 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. As detailed further below.
8. Claim 14 (and 15) are additionally rejected because claim 14 recites the limitation “essentially all of the physiological and morphological characteristics of soybean cultivar 2935708.”
The limitation “essentially” is a relative term. Neither the specification nor the claim provides any guidance to what traits, or what number of traits, are required to fall within the scope of the claims. For example, claim 14 requires only two generations, but Table 28-2 of Fehr (op. cit. p. 170) teaches that five generations might be required.
9. Claims 1, 2, 7, 9, 13, 14, 17, 18, 19, and 21 are rejected because they recite the limitation “2935708” and/or a blank line in reference to soybean 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 soybean 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 “2935708” 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.
Claim Rejections - 35 USC § 112(a)
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 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)
10. Claims 1-26 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 2935708.
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.
On page 62, Applicant indicates seeds will be deposited. Spec., paras. 0263-66.
The word and context of “irrevocably” in line 8 of paragraph 0263 is noted. (Also para. 0266 part (2).)
All claims require a perfected deposit to be considered patentable.
The Written Description Requirement of 35 USC 112(a)
11. Claims 8, 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.
Claim 1 is drawn to a plant or seed of the claimed soybean cultivar 2935708. All claims are rejected under 35 USC 112(b) as being indefinite. The rejected claims are drawn to soybean plants derived from the soybean cultivar 2935708 by providing at least one mutation (claim 8), an added gene (claim 10).
Further regarding the mutation, a “desired trait” is conferred to the soybean with no limit as to the trait. Additionally, in the base claim of claim 8, that is claim 7, a “mutation” produces a “desired trait” but with no explanation or teachings as to how to go from a random mutation to a “desired trait.”
Additionally, in claim 8 there are no limits on the traits associated with 2935708 that may be changed and which may be retained.
Further, claim 9 is open-ended as to how “at least one nucleic acid sequence” is added and also is completely open-ended as to how many are added. If added by backcrossing, for example, a large number of additional traits are genes can be added in addition to the intended trait and/or gene and/or nucleic acid sequence change.
Claim 11 is included in this rejection because of the possibility of bringing in additional traits with the recited traits.
Claim 15 is included in this rejection because it is open-ended with how many other traits are brought in in claim 14 and only two generations of backcrossing are required. Also, there is a tension in claim 15 between an added trait but also have “essentially all of the physiological and morphological characteristics of soybean cultivar 2935708.” (See also rejection under 35 USC 112(b) supra.)
Further, as discussed above, Moore teaches that the commercial soybean gene pool is shallow. Moore (op cit.).
Claim 19 is included in this rejection because it reads on the deposited soybean cultivar with a genetic change. But which genetic change? Any nucleotide in the genome could be changed. And to what effect?
Combining these strands of interpreting these claims, these claims encompasses a vast genus of soybean plants.
Furthermore, Applicant’s explicit definition of ‘plant’ in paragraph 0039 includes tissue culture. Somaclonal variation of a plant obtained from tissue culture increases the size of the genus encompassed by the claims. See, for example, Bairu et al. (2011) Plant Growth Regul 63:147-73.
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 2935708 is only, or will be, described and enabled by the to-be-perfected deposited seeds.
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 single soybean plant by deposit (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 soybean plant is infringing the instant claims, and therefore, the public has not been put on notice with a sufficient description of the claimed invention.
Also incorporated by reference here is the discussion of the similar-in-phenotype soybean plants discussed below. Applicant’s broad definitions appear to encompass other soybeans plants known in the art.
Dependent claims are included in this rejection because none provide further limitations obviating this rejection.
Written Description / Specification
12. Claims 1-26 are rejected because the instant specification fails to satisfy the written description requirement of 35 U.S. l 12(a) because it does not provide a description sufficient to conduct an to conduct an examination, including search of the prior art, in particular in regard to the breeding history.
The MPEP requires:
he 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).
This is emphasized in the Enzo v. Gen-Probe decision.
Furthermore, the Guidelines state that "'[o]nce the patent issues, the description must be sufficient to aid in the resolution of questions of infringement.'" Guidelines at 1107-08 n. 6 (quoting Deposit of Biological Materials for Patent Purposes, Final Rule, 54 Fed. Reg. 34,864, 34880 (Aug. 22, 1989) (codified at 37 C.F.R. pt. 800)).
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 1022, 62 U.S.P.Q.2d 1289, 1295 (Fed. Cir. 2002).
The parental germplasm is important to understanding the claimed variety.
Applicant claims a novel soybean cultivar.
This variety is, in part, distinguishable by its phenotypes, e.g. Table 1 (pp. 8-9).
No breeding history is not provided. The instant disclosure is incomplete as to the breeding history.
The requirement of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding.
Regarding Plant Patents, MPEP § 1605 states that the description should include
a complete detailed description of the plant and the characteristics thereof that distinguish the same over related known varieties . . . The specification should also include the origin or parentage.
Other bodies that grant intellectual property protection for plant varieties require breeding information to evaluate whether protection should be granted to new varieties. 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. USDA (2023) Applying for a Plant Variety Certificate of Protection https://www.ams.usda.gov/services/pvpo/application-help/apply (accessed 1 May 2023).
Additionally, 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, n 14 & n. 30).
While the USPTO, USDA, and UPOV have different laws governing intellectual property rights, all recognize that a breeding history is an essential part of adequate description of the plant sought to be protected.
The breeding history is also necessary to aid in the resolution of patent infringement by providing information necessary to determine whether differences in plants where genetic differences, differences caused by the environment, or differences within the accepted variation within a variety. 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) and Ex Parte McGowen, Board Decision in Application 14/996,093, 2020). 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.
Moreover, a specification devoid of a 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 aside from one parent, is not known to the public, the public could only rely on the phenotypes of the claimed plant for assessing potential infringement.
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. The assumption that elite cultivars are composed of relatively homogenous genetic pools may be false. Haun et al. (2011) Plant Physiol. 155:645-55; see p. 645, l 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 (Id., p. 645, R col., para. 2, to 646, L col., para. 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. Großkinsky et al. (2015) J. Exp. Bot. 66:5429-40 (see p. 5430 L col., para. 2, and R col., para. 2). In view of this variability, a breeding history is an essential and the least burdensome way to provide genetic information needed at adequate describe a newly developed plant.
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 to identify any and all other potential names for all parental lines utilized in the development of the instant cultivar.
For example, 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 either 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(s) as well (i.e., grandparents).
Applicant is also 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). 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).
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).
See also, the other cultivars discussed below which share a number of phenotypes with the instant claimed cultivar. There are only a few phenotypes commonly recited in a cultivar’s “Table 1” and there is no requirement to ‘fill in all the blanks.’
Thus a description of the ancestral germplasm is necessary to understand the invention.
instant 2021/0378198 USP 11,191,230
Cultivar 2935708 3421683 5PZUF97
Hypocotyl color: green white white
Seed Coat Color (Mature) clear clear yellow
Seed Coat Luster (Mature) dull dull dull
Color (Mature Seed) yellow yellow
Leaflet Shape: ovate ovate ovate
Growth Habit: indet. indet. indet.
Flower Color: white white white
Hilum Color (Mature Seed): black black black
Plant Pubescence Color: light tawny light tawny lt. tawn.
Pod Wall Color: brown brown brown
Relative Maturity: 3.7 3.6 3.8
Plant Lodging Score: 1.7/5 2.3 2.0
Plant Height: 93 cm 75 “5”
Seed protein 38.76% ??? 34.9
Percent Oil 22.53% ??? 19.6
SCN Race 3 resistant resistant unk.
SDS mod. toler. “6”
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969). MPEP § 804.
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
13. Claims 1-26 rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-26 of copending Application Serial No. 18/679,094 in view of Ramli et al.
Application No. 18/679,094 is drawn to cultivar 3707635 and is also assigned to Confluence Genetics LLC. The claim language is highly similar between the two applications.
The phenotypes recited in Table 1 of the ‘094 Application (p. 4) are the same except for minor differences. One of these, height, can occur from environmental variation.
Tolerance to SDS is obviously advantageous in certain situations and in any case, the ‘094 Application is silent. There is a minor difference in lodging.
However, lodging is effected by the environment and planting practices. E.g., Ramli et al. (1980) Agronomy J 72 (6):904-06 “Influence of Induced Lodging on Pod Distribution and Seed Yield in Soybeans” (col. 1, para. 1)
Further, the cultivars cannot be distinguished by breeding history.
Allowable Subject Matter
14. The claimed soybean plant appears to be free of the prior art of record.
Conclusion
No claim is allowed.
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