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 .
Claims 1-20 are pending and examined on their merit herein.
Specification
The specification is objected for lacking a deposit date and a deposit number: on page 49, the deposit date and a deposit number are missing. It is assumed that Applicant will provide the appropriate information in response to the instant Office action.
Claim Rejections - 35 USC § 112
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.
Claims 1, 11, and 13 are rejected as being indefinite in their recitation "NCMA Accession _____" because the NCMA Accession Number is missing. Therefore, the metes and bounds of the claims are not clear. Amending the claims to recite the NCMA accession number would overcome the rejection.
Claims 1, 6, 10, 11, 13, 16, 17, 18, are rejected as being indefinite in their recitation “soybean cultivar 08064455” 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 “soybean cultivar 08064455” 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. This rejection can be obviated by amending the claims to recite the NCMA deposit number.
Dependent claims are also rejected because they fail to overcome the deficiencies of parent claims.
Claim Rejections - 35 USC § 112
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 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. 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 regarding 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.
35 USC 112 (a) states that “The specification shall contain a written description of the invention”. In evaluating written description, the threshold question is what is “an adequate written description”. This is question of fact that is evaluated by the factfinder (examiner). MPEP 2163.04 clearly states that “The inquiry into whether the description requirement is met must be determined on a case-by-case basis and is a question of fact. In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).”
The instant invention is a new soybean cultivar 08064455. So, the examiner will evaluate what is an adequate written description for a new soybean cultivar/variety. In reviewing this question of fact, the examiner analyzed how plant varieties are evaluated in the public domain. The review concluded that generally the minimum requirements for an adequate description of a new plant variety has a trait table and genetic information (via a breeding history). In reviewing applicant’s specification there is a phenotypic description as is seen in Table 1. However, there is no accompanying breeding history in the Specification. Because the Specification lacks a breeding history and that breeding history is part of the minimum description of a plant variety the applicant has not fulfilled the requirement of 35 USC 112(a) to provide a written description in the specification. The office’s reasonable basis for challenging the adequacy of written description is informed by a review of the following:
With regard to Plant Patents, MPEP 1605 states that a complete detailed description of a plant includes “the origin or parentage”.
A breeding history, including information about parentage and breeding methodology, is part of the requirements of Plant Variety Protection (PVP) applications. That information is used to “determine if development is sufficient to consider the variety new” (See “Applying for a Plant Variety Certificate of Protection”, USDA, https://www.ams.usda.gov/services/pv po/application-help/apply, downloaded 05/01/2023, (U)).
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, Explanatory Notes on Essentially Derived Varieties Under the 1991 Act of the UPOV Convention, April 6, 2017, See UPOV EDV Explanatory Notes 14 and 30 (V)).
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) (W) and Ex Parte McGowen Board Decision in Application 14/996,093, decided June 15, 2020 (X)). In both of these cases, there were many differences cited by the Applicant when comparing the prior art and the new plant variety. However, because the breeding history was available, these differences were deemed to be obvious and within the natural variation expected in a backcrossing breeding process. Without a breeding history in these cases, a complete comparison with the prior art could not have been possible.
As seen above in Ex Parte C and Ex Parte McGowan, a trait table is insufficient to differentiate varieties by itself. It has been long established that intracultivar heterogeneity exists in crop species. Haun et al. (Plant Physiology, Feb. 2011, Vol. 155, pp. 645-655 (Y)) teaches that the assumption that elite cultivars are composed of relatively homogenous genetic pools is false. (p. 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 (p. 645, right column and p. 646, left column). In addition to genetic variation, environmental variation may lead to phenotypic variation within a cultivar. (Großkinsky et al., J. Exp. Bot., Vol. 66, No. 11, pp. 5429-5440, 2015 (Z), p. 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 to adequately describe a newly developed plant.
The above factual evidence provides a reasonable basis that a breeding history is necessary written description. With this information the examiner has met the initial burden of presenting by a preponderance of evidence why a person of ordinary skill in the art would not recognize in an applicant’s disclosure a description of the invention defined by the claims. (See MPEP 2163.04). Please note, the citations above are not for legal authority, the legal authority relied upon by the examiner is the 35 USC 112(a) statute. The citations are presented to support the finding of fact that a breeding history is necessary to the adequate description of a plant.
Although not directly relied upon for the above written description position, a complete written description additionally helps drive examination and help with infringement verification.
MPEP 2163 (I) states “The written description of the deposited material needs to be as complete as possible because the examination for patentability proceeds solely on the basis of the written description. See, e.g., In re Lundak, 773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985); see also 54 Fed. Reg. at 34,880 ("As a general rule, the more information that is provided about a particular deposited biological material, the better the examiner will be able to compare the identity and characteristics of the deposited biological material with the prior art.").”
MPEP 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).
The breeding history aids in the resolution of patent infringement by providing information necessary to determine whether differences in the plants are genetic differences, differences caused by the environment, or differences within the accepted variation within a variety.
Moreover, a specification devoid of a complete breeding history hampers the public’s ability to resolve infringement analysis with plants already in the prior art as well as plants that have not yet been patented. Because the instant specification lacks the complete breeding history, the public will not be able to fully resolve questions of infringement. Since the breeding history, including the parents, is not known to the public, the public could only rely on the phenotypes of the claimed plants for assessing potential infringement.
Thus, an application that does not clearly describe the breeding history does not provide an adequate written description of the invention.
To overcome this rejection, Applicant must amend the specification/drawing to provide the breeding history used to develop the instant cultivar. When identifying the breeding history, Applicant should identify any and all other potential names for all parental lines utilized in the development of the instant cultivar and all other potential names for the claimed cultivar. If Applicant’s breeding history uses proprietary cultivar names, Applicant should notate in the specification all other names of the proprietary cultivars, especially publicly disclosed or patented cultivar information. If the breeding history encompasses a locus conversion or a backcrossing process, Applicant should clearly indicate the recurrent parent and the donor plant and specifically name the trait or transgenic event that is being donated to the recurrent parent. If one of the parents is a backcross progeny or locus converted line of a publicly disclosed line, Applicant should provide the breeding history of the parent line as well (i.e., grandparents). Applicant should identify the breeding method used, such as single seed descent, bulk method, backcross method, etc., and the filial generation in which the instant plant was chosen. Information pertaining to the homozygosity or heterozygosity of the parents as well as the instant plant should be set forth.
Applicant is reminded that they have a duty to disclose information material to patentability. Applicant should also notate the most similar plants which should include any other plants created using similar breeding history (such as siblings of the instant cultivar). If there any patent applications or patents in which sibs or parents of the instant plant are claimed, the serial numbers and names of the sibs or parents should be disclosed. This information can be submitted in an IDS with a notation of the relevancy to the instant application or as information submitted as described in MPEP 724 (e.g., trade secret, proprietary, and Protective Order).
35 USC 112(a) clearly states “The specification (emphasis added) shall contain a written description of the invention”. In the instant application, Applicant included some breeding history for cultivar 21250789 in the Specification and additional names for one parent in a separate Transmittal Letter communication. This disclosure is insufficient because it does not address all the issues set forth above, and the information provided in the Transmittal Letter with regard to additional names of one parent should be set forth in the specification. Absent the disclosure in the Transmittal Letter, one skilled in the art would not have known that the 16EN311013-26 parent is publicly available, is known by other names and is a prior art cultivar. A Transmittal Letter is not part of the Specification and cannot provide the written description required to be in the Specification. Thus, the breeding history for the claimed cultivar as disclosed in the Specification is incomplete. Moreover, the claims indicate Applicant intends to deposit seeds representative of the claimed cultivar. Paragraph [0072] states that “There is natural variation in soybean caused by genetics and environment.” Additionally, paragraph [0195] states the term “soybean plant” includes any single gene conversions of that cultivar, and said plant has essentially all the morphological and physiological characteristics of the cultivar. Thus, the claims are not directed to the deposited seeds or plants grown therefrom. The claims are directed to a genus of soybean plants and seeds that are genotypically and phenotypically different from the deposit, and have different traits from those disclosed in the specification. Given these differences, the complete breeding history for producing the claimed cultivar, including all names for the parents and for the claimed cultivar, are material for patentability. A specification devoid of a complete breeding history hampers the public’s ability to fully resolve questions of infringement.
WRITTEN DESCRIPTION
Claim 18 is 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.
Applicant claims a mutagenized soybean plant produced by the method of claim 17, wherein the plant comprises a mutation in the genome and otherwise comprises all of the morphological and physiological characteristics of soybean cultivar 08064455.
Applicant describes soybean cultivar 08064455 in Table 1 on pages 8-9 of the specification. Applicant describes how to introduce mutations into soybean cultivar 08064455 (paragraph 0215 of the specification).
Applicant does not describe the genus of mutagenized soybean plants derived from soybean cultivar 08064455. The definition in paragraph 039, on page 49 of the specification, explains that article “a” is to be construed to “cover both singular and the plural” unless otherwise indicated or clearly contradicted by the context. In view of this definition, the term “a mutation” would encompass any number of mutation 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 18 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 a mutation into soybean cultivar 08064455.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Schultze (US 7442856 B2, 2008-10-28) in view of Mason (2019, US 10,455,795).
The claims are drawn to plants, seeds and plant parts of soybean variety “08064455”, methods of introducing a transgene or locus conversion into the plant, and plants thereby produced, commodity products, and F1 progeny.
Schultze teaches a soybean variety 5512112 which the same indeterminate plant growth habit, purple flower color, gray pubescence color, yellow hilum color, brown pod wall color, and maturity group 0 (Table 1).
Schultze does not teach soybean variety 5512112 with 2,4 D and glufosinate resistance.
Mason teaches soybean 79150907 (Table 1; claim 1), which has the DAS-44406-06 event, which confers tolerance to 2,4-D, glyphosate, and glufosinate herbicides (column 7, lines 9-16).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to introduce the DAS-44406-06 event from Mason’s plant into soybean variety 5512112 by backcrossing. One of ordinary skill in the art would have been motivated to do so because doing so would confer additional herbicide resistances in soybean variety 5512112, thus allowing it to survive in a field sprayed with glufosinate and/or 2,4-D, in addition to glyphosate, to control weeds. Additionally, Carden et al suggests introducing genes that confer glyphosate and/or glufosinate resistance (column 15, 2B) into 5512112, including by backcrossing in a transgene.
Schultze teaches methods of introducing a gene or trait into a soybean plant by backcrossing, as does Mason (column 24, line 8, to column 26, line 34). Mason teaches that that when backcrossing, occasional variant traits may be introduced into the plant (column 24, lines 10-21). One of ordinary skill in the art would have used the backcrossing methods taught by Carden et al and/or those taught by Mason to introduce the DAS-44406-06 event into 5512112, and would thus have expected one or more variant trait in the backcross converted progeny. The resulting backcross converted progeny plant would be substantially identical in structure to the instantly claimed variety.
It is also noted that, in comparing the recurrent parent (the Schultze variety) and the backcross progeny (the instantly claimed variety), the 35 USC § 103 rejection in fact is based on the interpreted locus conversion (backcross) of Schultze, and likely there would be changes in the resultant progeny, and that progeny is likely the best point of comparison. However, the Office does not have the resources to create backcross progeny and test the traits to see what the normal range of acceptable variants would be. Applicant is pointed to MPEP § 2112.01, which states that “[w]here the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977)”. The Office’s position is that the proposed combination of Schultze and Mason is substantially identical in structure to the instantly claimed variety.
Backcross progeny are known to differ from their recurrent parent even when taken to the 5th generation. Boehm (2014, Molecular Marker Assisted Backcross Development and Evaluation of an Environmentally Friendly, Commercially Acceptable Low Seed Phytate Soybean, Master’s Thesis, University of Tennessee-Knoxville, pp 1-135) teaches that a high yielding soybean cultivar, 5601T, was used to develop 12 BC5 (5th generation backcross lines), which introgressed an LP (low phytate) trait from a soybean donor line (TNO9-239). The 5th generation backcross progeny were expected to be 98.4% genetically similar to the recurrent parent 5601T (see page 5). The backcross progeny was grown in two locations (ETREC and Milan) in two years, 2012 and 2013 (see Tables 5.4 and 5.5 on pages 132-133). Boehm’s Tables 5.4 and 5.5 show that the backcross progeny can differ substantially from the parents even when taken to the 5th generation. In Table 5.4, the backcross progeny differs only slightly from the recurrent parent for maturity, protein, and oil content. For yield, lodging, and height the differences were greater than 15%. For maturity, protein, and oil content, they were under 5%. Boehm’s Tables 5.4 and 5.5 show that the backcross soybean progeny can differ substantially from the parents even when taken to the 5th generation.
With regard to the differences in DUS traits. The quantitative traits disclosed with numeric values did not include any error bars or standard deviations. Itis understood these numbers are averages and that each individual plant will have some variation. It is also known in the art that these traits are influenced by growth conditions. See, for example, Xue et al. (PLOS ONE (2019) pp. 1-15) who teach that there is a wide range of heights for a given variety (see error bars on Figure 1 on page 5) and there are differences in height based on the different environments in which the plants were grown (E1 — E4 in Figure 1 on page 5). Similarly, Assefa et al teach variation in protein and oil content of soybean seeds (Frontiers in Plant Science (2019) Vol. 10; pp. 1-13).
For this reason, the only trait that can reliably be used to distinguish the instantly claimed cultivar from the prior art cultivar (recurrent parent) is the newly introduced herbicide resistance event DAS-44406-06.
It would have been obvious to one of ordinary skill in the art to introduce mutations, transgenes or locus conversions into the DAS-44406-06 introgressed 5512112, as one of ordinary skill in the art would have been motivated to add additional disease, pest and herbicide resistances into the plant to broaden the places it can grow to those infested by disease or pest and to broaden the herbicides that can be used in weed suppression. It would have been obvious to one of ordinary skill in the art to isolate nucleic acids from the plants during this process, as Schultze teach that molecular markers should be used in breeding with their plant (column 31, lines31-40).
It would have been obvious to one of ordinary skill in the art to treat the DAS-44406-06 introgressed 5512112 seeds or seeds produced by introducing transgenes or locus conversions into it with seed treatments, as one of ordinary skill in the art would have been motivated to prevent diseases like damping off.
It would have been obvious to one of ordinary skill in the art to produce commodity products from the DAS-44406-06 introgressed 5512112 seeds or seeds produced by introducing transgenes or locus conversions into it, as the production of these are why soybeans are frown by farmers.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application Nos. 18/890,436;; and 18/890,370; (reference applications). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Copending applications is each drawn to a soybean cultivar designated 02051391, and 09015455, respectively. Each of the soybean cultivars share with the instant soybean cultivar 08064455 the same yellow seed coat color, dull seed coat luster, yellow cotyledon color, ovate leaflet shape, indeterminate growth habit, purple flower color, yellow hilum color, gray plant pubescence color, brown pod wall color, and maturity group 000 (See Table 1 of each application); and the same DAS-44406-6 event conferring tolerance to 2,4-D herbicides, glyphosate herbicides, and glufosinate herbicides. The cultivars differ slightly or not at all in Relative Maturity: (000.8, 000.6, respectively, to the instant 000.6); Plant Lodging Score (6.6, 6.6, respectively, to the instant 6.1); Plant Height (cm) (71, 76, respectively, to the instant 76; Seed Size (# seed/lb): (3065, 2865, respectively to the instant 3385); Seed % Protein: (36.0, 35.3, respectively to the instant 33.3); and Seed % Oil: (18.5, 19.3, respectively to the instant 20.1).
It may be noted that environmental factors and/or cultivation practices alone do influences such traits.
For example, amount of day light received and growth temperature affects or influences relative maturity in soybean cultivars. See Setiyono et al. (Field crop Research, 100:257-271; 2007, see in particular, abstract; Figures 1-13; Also see Iowa state University Extension and Outreach, Soybean Planting Decision Tool, Forecast and Assessment of Cropping systems (Facts), Published 2018; Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Furthermore, soybean seed protein and seed oil content is influenced or affected by environmental conditions. See for example, Maestri et al. (J Sci Food Agric., 77:494-498, 1998; see in particular, abstract; Tables 1-6), also see OJo et al. (Global Journal of Agricultural Sciences, volume 1, NO. 1, pages 27-32, January 2002; see in particular, abstract, Tables 1-4; appendix 1).
Likewise, soybean plant height is influenced or affected by environmental conditions. See for example, Yang et al. (BMC Plant Biology, 21:63, 2021; see in particular, paragraph bridging left and right columns), also see Popovic et al. (Soil and food; 2nd International and 14th National Congress of Soil Science Society of Serbia, 25-28th September, Novi Sad, Serbia, 2017, pages 1-294; see in particular chapter on “Effect of nitrogen fertilization on soybean plant height in arid year”, tables 1-3; figures 1-3 at pages 65-71); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Likewise, soybean seed size is also affected or influenced by environmental conditions. See for example, Delouche (Hortscience, 15(6): pages 13-18, 1980; see in particular Figure 1 at page 15); Also see Whigham et al., (Agronomy Journal, 70:587-592; see in particular abstract, tables 1-4).
Likewise, environment and production practices impact lodging score in soybean. See for example, Cooper (Agronomy Journal, 63:490-493, 1971; see in particular abstract; Tables 1-7).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. US12127522B2, US12310314B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The Patented claims each drawn to a soybean cultivars that share with the instant soybean cultivar 08064455 the same yellow seed coat color, dull seed coat luster, yellow cotyledon color, ovate leaflet shape, indeterminate growth habit, purple flower color, yellow hilum color, gray plant pubescence color, brown pod wall color, and maturity group 000 (See Table 1 of each application); and the same DAS-44406-6 event conferring tolerance to 2,4-D herbicides, glyphosate herbicides, and glufosinate herbicides. The cultivars differ slightly or not at all in Relative Maturity; Plant Lodging Score; Plant Height; Seed % Protein; and Seed % Oil; etc.
For the same reasons stated above, it should be noted that environmental factors and/or cultivation practices alone do influences such traits. Therefore, the claims are not patentably distinct from each other.
Conclusion
No claims are allowed.
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WEIHUA . FAN
Primary Examiner
Art Unit 1663
/WEIHUA FAN/Primary Examiner, Art Unit 1663