DETAILED ACTION
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 .
Claim Status
Claims 1-20 are pending.
Claims 1-20 are examined on the merits.
Specification
The specification is objected for lacking a deposit date and a deposit number: on page 45, the deposit number in the sixth and seventh lines of the last paragraph are missing. Further, there is no date given for the date of the deposit. It is assumed that Applicant will provide the appropriate information in response to the instant Office action.
Additionally, the disclosure is objected to because of the following informalities: on page 65 in the 6th line of the first paragraph “from” appears to be misspelled as “form”. On page 21 in line 27 there is “a” missing between “selfed” and “sufficient number of generations”.
Appropriate correction is required.
Finally, the specification provides a value of WTGBf for Plant Morphological in Table 9 on Page 63. Then in the description of that figure states that the traits are listed in the following order: Flower, Pubescence, Pod color and Hilum. This indicates that the value G in table 9 is for pod color, however in the description of Table 9 the options for pod color are T=tan, B=brown, LBr=light brown, and S=segregating. There is no mention of G for pod color, however helpfully, G is described as gray for pubescence and therefore it is clear that the claimed variety has gray pod color, however the description of Table 9 should be corrected to clarify this.
Appropriate correction is required.
Claim Interpretation
In claim 1, “a plant” is interpreted as a plant grown from a seed of soybean variety CL1923860, a representative sample of seed of said soybean variety CL1923860, has been deposited under ATCC Accession Number PTA-____ , which can be found in the same claim.
Similarly, in claim 18, the “a plant” is interpreted as a plant grown from a seed of soybean variety CL1923860.
In claim 4, by BRI, the “a seed” is interpreted as a seed that the soybean plant of claim 3 is grown from, or as a seed that is a progeny of the soybean plant of claim 3.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 18-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claimed invention is directed to a judicial exception (abstract idea) without significantly more.
Claims 18-19 recite a method comprising isolating nucleic acids from a plant, a plant part, or a seed of soybean variety CL1923860, analyzing said nucleic acids to produce data, and recording the data (to a computer readable medium, claim 19).
According to MPEP 2106, the claim must not be directed to a judicial exception unless the claim as a whole includes additional limitations amounting to significantly more than the exception. The judicial exceptions (also called "judicially recognized exceptions" or simply "exceptions") are subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention, and are limited to abstract ideas, laws of nature and natural phenomena.
According to MPEP 2106.04, judicially recognized exceptions have been described using various other terms, including "physical phenomena," "products of nature," "scientific principles," "systems that depend on human intelligence alone," "disembodied concepts," "mental processes," and "disembodied mathematical algorithms and formulas."
In this case, analyzing said nucleic acids to produce data, and recording the data encompass scientific principles, mental processes, and/or disembodied mathematical algorithms and formulas, which are abstract ideas.
Isolating nucleic acid is a lab step. Analyzing said nucleic acids may comprise lab tests (part of analyzing). However, such isolating and lab test are routine methods, and do not constitute significantly more to the abstract idea.
Claim 20 merely recites using the data but does not recite how to use the data “for crossing, selection or advancement decision”. In addition, crossing or selecting is not recited as a step, only as a intend purpose. Thus, the claim is directed to abstract ideas.
Hence, as a whole, the claims are directed to abstract ideas without significantly more, which are deemed to be a juridical exception. Therefore, claims are directed to judicial exceptions without significantly more, and are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112 (Indefiniteness)
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.
Claim 1 is rejected as being indefinite in the recitation "ATCC Accession Number PTA-_____” because the ATCC Accession Number is missing. Therefore, the metes and bounds of the claim is not clear. Amending the claim to recite the ATCC accession number would overcome the rejection. Claims 2-17 are rejected for depending on independent claim 1 and failing to limit the scope of the claim to definite subject matter.
Claims 1, 6, 11, 13-15 and 18, are rejected as being indefinite in their recitation of “soybean variety . . . CL1923860”, “soybean plant . . . CL1923860”, “CL1923860 . . . plant(s)” because the recitation does not clearly identify the claimed plant cultivar and seed. Furthermore, the recitation does not set forth the metes and bounds of the claimed invention. Since the name “CL1923860” is not known in the art, the use of said name does not carry art recognized limitations as to the specific characteristics or essential characteristics that are associated with that denomination. In addition, the name appears to be arbitrary, and the specific characteristics associated therewith could be modified, as there is no written description of the plant that encompasses all of its traits. Dependent claims 2-5, 7-10, 12, 16-17 and 19-20 are also rejected because they fail to overcome the deficiencies of parent claims.
Claim 15 is rejected as being indefinite because the claim recites “A plant produced by the method of claim 14 or a selfed progeny thereof, wherein the plant or selfed progeny thereof comprises said single locus and otherwise comprises essentially all of the physiological and morphological characteristics of soybean variety . . . CL1923860”.
First, the specification does not define “essentially all”. In the dictionary, essentially means fundamentally. In this case, it is unclear what percentage of the physiological and morphological characteristics of soybean variety CL1923860 are essentially all, this could theoretically be 90%, 80%, 70%, 60% or another percentage of the characteristics of this variety. Given this the scope of the claim is unclear.
Second, claim 15 is a product by process claim depending on claim 14. However, the phrase “essentially all” contradicts the recitations of claim 14. Claim 14 recites the final step (step (e)) “repeating crossing or selection of later generation progeny plants to produce progeny plants that comprise the single locus and all of the physiological and morphological characteristics of said single locus and of soybean variety CL1923860 when grown in the same location and in the same environment”. Accordingly, a plant produced by the method of claim 14 should comprise “ all of the physiological and morphological characteristics of said single locus and of soybean variety CL1923860 when grown in the same location and in the same environment”.
Hence, the scope of the claim is unclear, and the claim is confusing and contradicting to the parent claim.
Appropriate correction and clarification are required.
Claim Rejections - 35 USC § 112 (Enablement)
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.
ENABLEMENT Regarding Biological Deposit
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 appears to employ the seed of novel plants. Since the seed claimed is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. If a seed is not so obtainable or available, the requirements of 35 U.S.C. 112 may be satisfied by a deposit thereof. The specification does not disclose a repeatable process to obtain the exact same seed in each occurrence and it is not apparent if such a seed is viable and further 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 with the date of deposit and proof of viability 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. In the instant case, the Specification has not explicitly stated that subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of the patent.
Although the rules do not specify a specific number of seeds to be deposited to meet the requirements of these rules, so long as the number of seeds deposited complies with the requirements of the Budapest Treaty International Depositary Authority (IDA) where the deposit is made, the USPTO would consider such a compliant submission as satisfying the rules under 37 CFR 1.801 through 1.809. Note that the American Type Culture Collection (ATCC), a Budapest IDA, requires a minimum deposit of 625 seeds; other IDAs may have different minimum requirements. Accordingly, any depositor should confirm that the number submitted to a specific IDA complies with that IDA's requirements for seed deposits.
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 ATCC 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.
Written Description
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.
Claims 13 and 17 are broadly drawn to a genus of plants produced by the method of claim 11, and a seed that produces the plant of claim 13.
Claim 11 recites introducing at least one transgene or locus conferring the desired trait into the soybean plant CL1923860.
Please note claim 11 does not recite introducing a single transgene or locus. “At least one transgene or locus” encompasses unlimited number of transgenes or loci.
The specification describes some morphological characteristics of CL1923860 (pages 94-97, Tables 25-26). CL1923860 comprises only specific transgenes (MON 89788, A5547-127, MON87708, Rag1_S and Rps1c) which confer herbicide tolerance and phytophthora resistance and not any other transgenes or locus conversions.
However, the specification does not provide any example of CL1923860 further comprising a transgene or locus conversion, not to mention the common structure feature of the genus of plants or seeds.
In prior art, Li et al (Li, Plant Biotechnology Journal 20.6 (2022): 1110-1121) teach that an introduced locus conversion comprising a transgene (ST1 locus) dramatically and significantly changes many physiological and morphological characteristics/traits of the original soybean variety (GR8836), and changed oil content (p1110, Summary; p1112-1113, Results).
Thus, unlimited number of transgene or loci would dramatically and significantly change many physiological and morphological characteristics/traits of the original soybean variety. In another word, the plant produced by the method of claim 11 would not maintain all of physiological and morphological characteristics of CL1923860.
The structure of CL1923860, and the morphological and physiological characteristics that are connected to the structure does not comprise any further transgenes, thus does not describe the common structure feature of the genus of converted seeds, plants, plant parts, and does not represent genus of converted seeds, plants, or plant parts.
Therefore, the application has not met either of the two elements of the written description requirement as set forth in the court' s decision in Eli Lilly, and has not shown her/his possession of the claimed genus at the time of the application.
Amending claim 11 to recite a single transgene or locus would overcome the rejection.
With respect to claim 17, Applicant claims a mutagenized soybean seed that produces the plant of claim 13, wherein the plant comprises a mutation in the genome and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar CL1923860.
Applicant describes soybean cultivar CL1923860 on pages 62-65 of the specification including tables 9 and 10. Applicant describes how to introduce mutations into soybean cultivar CL1923860 (Last paragraph on page 30 of the specification).
Applicant does not describe the genus of mutagenized soybean plants derived from soybean cultivar CL1923860. Claim 11 upon which claim 13 and therefore claim 17 depends are drawn to introducing at least one transgene, and therefore teaches introducing multiple transgenes. In view of this definition, the term “at least one mutation” would encompass any number of mutations that may confer any number of morphological and/or physiological characteristics to the mutant plant. Applicant has failed to describe said genus.
See Vas-Cath Inc. v. Mahurkar 1991 (CA FC) 19 USPQ2d 1111, 1115, 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 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. In this case, there is no way that a practitioner would 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.
Claim 17 is thus a “reach through” claim in which the Applicant has described a starting material and at least one method step, but has not described the resulting product; and wherein the genus of products that can be produced by the recited method steps and materials is so large that one of skill in the art is not able to envision the members of the genus. (See Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004)). Accordingly, the specification fails to provide adequate written description to support the genus of soybean plants produced by introducing at least one mutation into soybean cultivar CL1923860.
Lack of Breeding History
Claims 1-20 are rejected under 35 U.S.C 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because the specification does not include a complete breeding history which makes clear the starting material and breeding steps used to produce the instant variety and this history is not found elsewhere in the disclosure.
Specifically, in the instant application, applicant has not provided any description of the origin of the variety. Applicant has provided a description of plant traits as seen in the specification (Pages 62-65 of the specification including tables 9 and 10). The instant application is incomplete as to the complete breeding history used to produce the claimed plant variety.
The breeding history is incomplete because the specific pedigree and breeding history of the claimed plant line is not known in the art and a complete and clear breeding history is not provided in the Specification. Applicant provides the following statement describing the origins of the claimed variety “The … CL1923860 … line has been selfed sufficient number of generations to provide a stable and uniform plant variety” (Specification, Page 21, Lines 24-28).
This leads to several question including:
What does selfed a sufficient number of generations mean?
Does this mean that the parent lines were crossed to produce F1 hybrid lines which were then selfed for numerous generations? Does this instead mean that a backcrossing method was employed which was followed by a sufficient number of generations?
Given the description provided by Applicant, the parents of the claimed variety and the initial breeding steps which were followed by a sufficient number of generations of selfing are not clear. The specification does use any other alternative means or description which provides the information on the genetics of the instant variety which would be conveyed through a complete breeding history and therefore the specification does not describe the genetic characteristics of the claimed variety.
Further, it is not clear whether the claimed soybean variety has any other synonyms or tradenames, and importantly, as noted above, what is the source of this plant line or the lines used to produce it. The breeding history must be clarified regarding synonyms, tradenames and the sources thereof as well as the specific steps taken to produce the instantly claimed line.
Applicant claims a new soybean variety and methods of producing the variety. This introduces a question of fact: what is an adequate written description of a soybean variety.
As the factfinder, the Examiner conducted a search of the relevant art which provided answers on what constitutes written description of a plant variety. A plant variety is defined by both its genetics (which are described in a breeding history) and its traits. The following are presented as a review of the state of the art with respect to the question of fact presented above; what is written description of a plant. The following is not presented as a legal basis for the rejection.
In plant breeding, a breeding history in considered critical in describing a variety and assessing the intellectual property rights of a plant. With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “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” (See “Applying for a Plant Variety Certificate of Protection” by the USDA, Exhibit A).
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 (See UPOV EDV Explanatory Notes, 14 and 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). 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 lacking 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 a specific and complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the exact parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants 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. Haun teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (See Haun, Page 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. (See Haun, Page 645 right column and Page 646 left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (See Großkinsky, page 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 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 must amend the specification/drawings to provide a complete and clear breeding history used to develop the instant variety or 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 variety. 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 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 is also reminded that they have a duty to disclose information material to patentability. Applicant should notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant variety). 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).
Of interest the MPEP notes that in addition to demonstrating that the applicant is in possession of the claimed invention that the disclosure should have several other characteristics as follows:
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).
In the instant case the description of the genetics of the variety provided in the specification is insufficient to permit verification that the deposited biological material is in fact that disclosed and the trait table is insufficient to distinguish one claimed variety from another claimed variety, see double patenting rejection below.
As such claims 1-20 are rejected as lacking adequate written description.
Close Prior Art
This statement is provisional because the parents and breeding history of the instant variety have not been provided and therefore the genetics of the instant variety as can be described by a breeding history cannot be compared to the prior art and as such the following analysis relies on the morphological and phenotypic information provided on pages 62-65 of the specification including the trait table on page 63 (Table 9).
The instantly claimed soybean appears to be free of the art for the following reasons:
The closest prior art appears to be found in US Patent US 9,961,859 B1, Patented May 8, 2018 by Justin T. Mason.
The variety claimed in the prior art reference shares many characteristics with the instantly claimed varieties including a herbicide transgene, relative maturity, growth habit, flower color, and pubescence color. However, the varieties appear to differ in sulfonylurea tolerance, metribuzin tolerance, aphid gene, pod wall color, hilum color, phytophthora gene, chloride sensitivity and incognita resistance/susceptibility. The parents and breeding history of the two varieties have not been compared.
Given these distinctions and the information provided on the instant variety it appears to be free of the art.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN JAMES SULLIVAN whose telephone number is (571)272-0561. The examiner can normally be reached 7:30 to 5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, 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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//BRIAN JAMES SULLIVAN/ Examiner, Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663
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