DETAILED ACTION
Claims 1-17 and 19-20 are pending.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The objection to the specification is withdrawn in light of Applicant’s deposit statement.
The rejection of claims 1-20 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the subject matter that the inventor or a joint inventor, or for pre-AIA the applicant, regards as the invention is withdrawn in light of Applicant’s deposit statement, amendment of claim 13, and disavowal of “a plant of soybean cultivar 16002162” as reading on the definition of “soybean plant” in ¶195 and “single locus conversion” as encompassing anything other transgenes (response pg 5-7).
The rejection of claims 1-20 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35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement is withdrawn in light of Applicant’s deposit statement. Applicant is reminded that because viability testing of all deposits is required before they can be considered to meet the requirements of 37 CFR 1.801- 1.809, they are advised to perfect the deposit as early as is possible, and before the payment of the issue fee. Failure to perfect a deposit by the date of payment of the issue fee may result in abandonment of the application for failure to prosecute.
The rejection of claims 1-20 under 35 U.S.C. 102(a)(1) as being anticipated by Eby (2018, US 9,907,280) is withdrawn in light of Applicant having overcome the indefiniteness rejection.
The rejection of claims 1-20 on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of each of U.S. Patent Nos. 9,907,280 is withdrawn in light of Applicant having overcome the indefiniteness rejection.
Claim Rejections - 35 USC § 112
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.
Claims 1-17 and 19-20 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.
This is rejection is different that the rejection set forth in the Office action mailed 11 April 2025. The previous rejection was overcome by Applicant having overcome the indefiniteness rejection/
35 USC 112 requires that the specification have a written description of the invention:
35 U.S.C. 112 Specification.
(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. (emphasis added)
The instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide a description sufficient to conduct an examination, including a complete search of the prior art.
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.").
The instant Specification fails to satisfy the written description requirement of 35 U.S. Code § 112(a) because it does not provide enough description to be sufficient to aid in the resolution of questions of infringement.
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 application, a full examination cannot be conducted because applicant failed to provide the complete breeding history for the instantly claimed plant variety. A plant variety is defined by both its genetics (i.e., its breeding history) and its traits. In the instant application, Applicant has provided a description of the plant traits as seen in the specification (Table 1) and the names of its parents. However, two of those parents, RM1913C7-COYNN-20 and HT3-005, are not described in the prior art and it is not known if they are known by other names. The instant application is thus incomplete as to the breeding history used to produce the claimed plant variety.
The criticality of a breeding history in assessing the intellectual property rights of a plant is well recognized in the field of plant breeding. 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” (USDA, “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, see 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, 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 an incomplete 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 phenotype 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 is false (Haun et al, 2011, Plant Physiol. 155:645-655; see pg 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 (pg 645, right column, paragraph 2, to pg 646, left column, paragraph 3). In addition, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al, 2015, J. Exp. Bot. 66:5429-5440; see pg 5430 left column, paragraph 2, and right column, paragraph 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 must amend the specification 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).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-17 and 19-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Eby (2018, US 9,907,280) in view of Wohleser (2021, US 10,897,870).
The claims are drawn to plants, seeds, cells, and tissue cultures of soybean cultivar 16002162, methods of breeding it, F1 progeny produced from it, methods of introducing a transgene or single locus conversion into it and plants thereby obtained, a method of mutagenizing it, and a method of producing a commodity product from it.
‘280 claims a soybean variety, 64492916, which is also known as 14915619-29. 14915619-29 is the recurrent parent used to produce 16002162 (¶68).
Like the instant soybean, 14915619-29 has purple flowers, imperfect black hila, grey pubescence, yellow seed coat color, dull seed coat luster, yellow cotyledons, ovate leaflets, indeterminate growth habit, the rhg1 soybean cyst nematode resistance gene, and the MON89788 and MON87708 events (Table 1 and the two paragraphs immediately following). The instant soybean and 14915619-29 have similar values for relative maturity lodging, height, seeds/lb, seed protein % and seed oil %,
‘280 does not teach 14915619-29 with the A5547-127 event and brown pod walls and without the Rps1c gene.
Wohleser teaches a soybean plant with the A5547-127 event and brown pod walls and without the Rps1c gene (Table 1 and the two paragraphs immediately following).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify 14915619-29 claimed in ‘280 to introgress in the A5547-127 event from the soybean plant described in Wohleser. One of ordinary skill in the art would have been motivated to do so because the A5547-127 event confers resistance to glufosinate herbicides, This, along with the glyphosate resistance-conferring MON89788 event and the dicamba resistance-conferring MON87708 event, would provide the plants with resistance to the herbicides commonly used in soybean farming.
Whether one of ordinary skill in the art would select for plants having 14915619-29’s tan pods or the brown pods of Wohleser’s plant’s brown pods is a design choice, as pod color has no economic importance.
Whether one of ordinary skill in the art would select for plants having the Rps1c Phytophthora resistance gene or not is a design choice that depends on where one intended to grow the resulting plant. If one of ordinary skill in the art did not intend to grow the plant in areas infested with Phytophthora or not.
The resulting plants would encompass those plants like the instantly claimed soybean cultivar. Claims 1-17 and 19 in ‘280 are identical to instant claims 1-17 and 20 except for the name of the variety.
It would have been obvious to one of ordinary skill in the art to apply those same methods to and produce the same products from the plant produced by introgressing the A5547-127 event into 14915619-29, as these are all routine methods performed with soybean cultivars and routine products produced from them. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to determine the genotype of the resulting soybean plant by detecting at least one polymorphism and recording the data, as this is a routine step in breeding with a soybean plant, such as in the methods claimed in ‘280’s claims 11-12 and 14-16.
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 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 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); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-17 and 19-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent Nos. 9,907,280 in view of Wohleser (2021, US 10,897,870).
The claims are drawn to plants, seeds, cells, and tissue cultures of soybean cultivar 16002162, methods of breeding it, F1 progeny produced from it, methods of introducing a transgene or single locus conversion into it and plants thereby obtained, a method of mutagenizing it, and a method of producing a commodity product from it.
‘280 claims a soybean variety, 64492916, which is also known as 14915619-29. 14915619-29 is the recurrent parent used to produce 16002162 (¶68).
Like the instant soybean, 14915619-29 has purple flowers, imperfect black hila, grey pubescence, yellow seed coat color, dull seed coat luster, yellow cotyledons, ovate leaflets, indeterminate growth habit, the rhg1 soybean cyst nematode resistance gene, and the MON89788 and MON87708 events (Table 1 and the two paragraphs immediately following). The instant soybean and 14915619-29 have similar values for relative maturity lodging, height, seeds/lb, seed protein % and seed oil %,
‘280 does not teach 14915619-29 with the A5547-127 event and brown pod walls and without the Rps1c gene.
Wohleser teaches a soybean plant with the A5547-127 event and brown pod walls and without the Rps1c gene (Table 1 and the two paragraphs immediately following).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to modify 14915619-29 claimed in ‘280 to introgress in the A5547-127 event from the soybean plant described in Wohleser. One of ordinary skill in the art would have been motivated to do so because the A5547-127 event confers resistance to glufosinate herbicides, This, along with the glyphosate resistance-conferring MON89788 event and the dicamba resistance-conferring MON87708 event, would provide the plants with resistance to the herbicides commonly used in soybean farming.
Whether one of ordinary skill in the art would select for plants having 14915619-29’s tan pods or the brown pods of Wohleser’s plant’s brown pods is a design choice, as pod color has no economic importance.
Whether one of ordinary skill in the art would select for plants having the Rps1c Phytophthora resistance gene or not is a design choice that depends on where one intended to grow the resulting plant. If one of ordinary skill in the art did not intend to grow the plant in areas infested with Phytophthora or not.
The resulting plants would encompass those plants like the instantly claimed soybean cultivar. Claims 1-17 and 19 in ‘280 are identical to instant claims 1-17 and 20 except for the name of the variety.
It would have been obvious to one of ordinary skill in the art to apply those same methods to and produce the same products from the plant produced by introgressing the A5547-127 event into 14915619-29, as these are all routine methods performed with soybean cultivars and routine products produced from them. Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to determine the genotype of the resulting soybean plant by detecting at least one polymorphism and recording the data, as this is a routine step in breeding with a soybean plant, such as in the methods claimed in ‘280’s claims 11-12 and 14-16.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anne R. Kubelik, Ph.D., whose telephone number is (571) 272-0801. The examiner can normally be reached Monday through Friday, 9:00 am - 5:00 pm Eastern.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Shubo (Joe) Zhou, can be reached at (571) 272-0724. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Anne Kubelik/Primary Examiner, Art Unit 1662