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 1-26 are pending.
Claims 1-26 are examined on the merits.
Specification
The disclosure is objected to because of the following informalities: In paragraph 266 on page 61 of the instant specification the NCMA accession number is missing, further there is no date of deposit.
Appropriate correction is required.
Claim Objections
Claim 4 is objected to because of the following informalities: The claim is unnecessarily complicated. It recites, “A method for producing a soybean seed, wherein the method comprises fertilizing a soybean plant and harvesting the resultant soybean seed, wherein the soybean plant is the soybean plant of claim 1.” It is suggested that it be amended as following to be simpler and clearer:
“A method for producing a soybean seedcomprising: (a) fertilizing [[a]] the soybean plant of claim 1 and (b) harvesting the resultant soybean seed
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.
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.
Claims 1, 9, 14 and 21 all recite blanks instead of the accession number. In the absence of an accession number, the metes and bounds of the claims cannot be determined. Claims 2-8, 10-13, 15-20 and 22-26 are rejected for depending from indefinite claims and failing to recite additional limitations that would render the claims definite.
Claim 2 recites, “A soybean plant, or part thereof, of the plant or seed of claim 1.” It is unclear if the clause “or part thereof” is intended to only modify the soybean plant or the seed as well. These would be distinct interpretations, because the in the case of the later parts of seeds would be explicitly contemplated whereas they would not with the former interpretation.
Claim 5 is drawn to a soybean seed produced by the method of claim 4 “wherein the resulting soybean seed is an F1 offspring or the product of self-fertilization.” The claim does not specify what plant is being self-fertilized. It could be the F1 offspring or even a higher generation progeny, because the method of claim 4 is open to additional steps given the use of “comprising.” Thus, the metes and bounds of the claim cannot be determined. Note that claim 5 uses the phrase “resulting seed” while claim 4 recites, “the resultant seed.” It is unclear if this difference is intentional. If so, please set forth how these two phrases are intended to differ in meaning.
Claim 19 is drawn to “A soybean plant produced by the method of claim 18, wherein said plant has all of the physiological and morphological characteristics of soybean cultivar 3703488”. Claim 18 requires that genome of plant be edited, so it unclear how it could have “all of the physiological and morphological characteristics of soybean cultivar 3703488.” Thus, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 112 (Improper Claim Dependence)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 23-26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 2 is drawn to “A soybean plant, or part thereof, of the plant or seed of claim 1.” Claim 1 is limited to “A plant or a seed of soybean cultivar….” Claim 2 appears to expand upon the scope of claim 1 to include any plant part.
Claims 23-26 are drawn to the soybean plant of claim 1, wherein the soybean plant is used for certain specific functions.
Given that the claim is drawn to the soybean plant and these uses do not affect the characteristics of the plant these claims do not further limit the scope of the independent claim. Similar in some ways to a product-by-process claim, see MPEP 2113, the patentability of instant claims 23-26 is based on the product itself and not any implied use, especially as these uses do not require any specific features of the claimed plant. As such the broadest reasonable interpretation of claims 23-26 is the same as the broadest reasonable interpretation of claim 1 upon which they all ultimately depend and as such these claims fail to limit the scope of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 112 (Lack of Written Description)
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.
Claims 8 and 10 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are broadly drawn to soybean plant made by open ended methods that introduce mutations or nucleic acids to a plant of soybean cultivar 3703488.
The claimed genus includes plants made using soybean cultivar 3703488 comprising an unlimited number of structural differences and trait alterations compared to soybean cultivar 3703488.
The instant disclosure describes soybean cultivar 3703488 and contemplates some transgenes and loci that can be introduced into soybean cultivar 3703488.
These descriptions are insufficient because they fail to represent a broad amorphous genus of plants made using soybean cultivar 3703488 as starting material.
Given the broad scope of the claimed genus, the lack of working examples and the failure to describe the structures required to confer the claimed function, one of skill in the art would not have recognized that Applicant was in possession of the claimed genus at the time of filing.
Written Description (Lack of Breeding History)
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 written description requirement.
The instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because there is no breeding history included in the disclosure.
Specifically, in the instant application, applicant has only provided a description of the plant traits as seen in the specification. The instant application is incomplete as to the breeding history used to produce the claimed plant variety.
The breeding history is incomplete because the pedigrees of the plant line is not known in the art and not provided in the Specification. It is not clear whether 3703488 has any other synonyms or tradenames, nor 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.
In the instant application, Applicant claims a new plant variety and methods of producing the variety. This introduces a question of fact: what is an adequate written description of a plant variety.
In searching for an answer to the above question of fact, a search of the relevant art provided answers on what constitutes written description of a plant variety. A plant variety is defined by both its genetics (which are described in the 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 the 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.
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 the 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 also 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).
Claim Rejections - 35 USC § 112 (Enablement)
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
Deposit Rejection
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 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 and/or plant claimed 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, or seed of the claimed plant 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.
Applicant has NOT indicated that Applicant has deposited the seeds at the NCMA 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 indicating that all restrictions will be irrevocably be removed upon issuance of a patent or alternatively that the deposit is made and accepted under the terms of the Budapest Treaty, the NCMA Accession No. and evidence of deposit to overcome this rejection.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-26 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Rhodes (US 10,426,124 B2), patented October 1, 2019.
The applied reference has a common assignee with the instant application given that the instant applicant Confluence Genetics bought the reference applicant Schillinger Genetics before the effective filing date of the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Rhodes discloses soybean Cultivar 179565921658 which appears to be indistinguishable from the instantly claimed variety based upon the characteristics reported in both of the specifications, specifically the mendelian controlled color traits are identical between the two cultivars. Moreover, neither the patented reference nor the instant case provide any breeding history for the claimed variety such that genetic lineage could be compared between the two lines, see table 1 of each application. Thus, it appears that the lines are same.
See In re Best, 195 USPQ 430, 433 (CCPA 1977), which teaches that where the prior art product seems to be identical to the claimed product, except that the prior art is silent as to a particularly claimed characteristic or property, then the burden shifts to Applicant to provide evidence that the prior art would neither anticipate nor render obvious the claimed invention.
It also should be noted that many of the instant claims are claiming scopes that are broader than just the deposited seeds which would encompass related varieties.
Further, while the reference does not include claims which correspond to instant claims 21-22, the reference teaches feed products using Cultivar 179565921658 (Rhodes, Page 18, Paragraph 0199).
Further, while instant claims 23-26 are drawn to the soybean seed of claim 1 used in certain contexts, the actual structure of the seed is not distinct from that of claim 1 and therefore given that claim 1 is anticipated by the reference so are these dependent claims.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-20 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-20 of prior U.S. Patent No. US 10,426,124 B2. This is a statutory double patenting rejection.
See rejection under 35 USC 102 above.
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 at (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