DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
2. Claims 9, 12, 13, 17, 18, 20, 21, 25-27, 31, 63-65, and 69 are pending.
3. Claims 10, 12, and 13 remain withdrawn from consideration.
4. Claims 9, 17, 18, 20, 21, 25-27, 31, 63-65, and 69 are examined herein.
5. The objection to the specification is withdrawn in view of Applicant’s amendment to the disclosure.
6. The objections to claims 63 and 64 are withdrawn in view of Applicant’s amendments to the claims.
7. The rejection of claims 9, 17, 18, 20, 21, 25-27, 31, and 64 under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments to the claims.
Election/Restrictions
8. Applicant’s election of Group I, in the reply filed on May 19, 2025 is acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election wastreated as an election without traverse (MPEP § 818.01(a)). Claims 9, 17, 18, 20, 21, 25-27, 31, and 63-65 were examined. Claims 10, 12, and 13 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 19, 2025.
In the instant amendments, Applicant added new claim 69. Given that claim would have been included in the elected Group, it is rejoined and examined herein.
Claim Objections
9. In claim 27, the term “SCN” should be spelled out at its first use.
In claims 63-65, the phrase “tolerant to nematodes or nematode eggs of SCN or Pratylenchus or reniform nematodes” should be amended, to clarify the wording. For example, the phrase may be amended to recite: --tolerant to nematodes selected from the group consisting of SCN, Pratylenchus and reinform nematodes; or tolerant to the eggs of any of said nematodes--. Appropriate correction is required.
Claim Rejections - 35 USC § 112 - Indefiniteness
10. 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.
11. Claims 63-65 remain 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.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s arguments filed on December 3, 2025 have been fully considered by they are not persuasive.
In claim 63, the phrase “where the field contains, contained or is expected to contain” renders the claim indefinite as it is unclear how or whether the recitation limits the active step of the method. For example, it is unclear how one could determine whether a field “contained” or is “expected to contain” the recited nematodes or their eggs; or how the two types of a field are different given that neither presently contains nematodes or their eggs.
In claim 65, the term “such as” is an exemplary limitation that renders the claim indefinite. The term makes it unclear whether the limitations following the term are required by the claim, which makes the intended scope of the claims unclear. See MPEP 2173.05(d).
Applicant argues that the amendments to the claims overcome the rejection (page 10 of the Remarks). Applicant’s amendments are acknowledged and the rejection has been modified accordingly. However, claims 63-65 remain rejected for the reasons set forth above. It is noted that claim 65 continues to recite the exemplary limitation “such as.”
Claim Interpretation
12. As set forth above, the claims have been found indefinite. Claim 9, as instantly amended, is directed to any soybean plant “comprising … a nucleic acid molecule comprising a nucleotide sequence of SEQ ID NO: 1, 2, 3, 4, 5, or 6.” Due to the use of the indefinite article in the phrase “a nucleotide sequence of,” the recitation is given its broadest reasonable interpretation as encompassing any partial sequence comprised within any one of SEQ ID NO: 1-6, including any dinucleotide.
Regarding the soybean product of claims 17 and 18, the claims do not require that the product comprise any of the nucleic acids recited in claim 9. For this reason, soybean meal ground seeds, flour or flakes obtained from any soybean plant would read on the product of said claims.
Claim 63 is read as requiring the active method step of planting the plant or seed of claim 9 in any field, including the field that does not contain any nematode eggs, but is only “expected” to contain them.
Claim 65 is similarly read as being limited solely by the active step of introducing into the genome of a soybean plant a nucleic acid molecule recited in claim 9.
Claim Rejections - 35 USC § 112(a) - Scope of Enablement
13. 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.
14. Claims 9, 17, 18, 20, 21, 25-27, 31, and 63-65 remain and claim 69 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for soybean plants, cells and seeds of the transgenic event EE-GM5, said plants, cells and seeds comprising the nucleic acid sequence that represents the full-length DNA of said event, does not reasonably provide enablement for the invention as broadly claimed; the specification does not reasonably provide enablement for the claimed genus of soybean plants, cells, plants and seeds comprising fragments of said event. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s arguments filed on December 3, 2025 have been fully considered by they are not persuasive.
In re Wands, 858 F.2d 731 (Fed. Cir. 1988) lists the following eight factors for determining whether undue experimentation would be required to practice an invention: (1) quantity of experimentation necessary; (2) amount of direction or guidance supplied; (3) presence or absence of working examples; (4) nature of the invention; (5) state of the prior art; (6) relative skill of those in the art; (7) predictability or unpredictability or the prior art; (8) breadth of the claims.
Applicant claims a soybean plant, cell, plant part, or seed comprising any of the nucleic acid molecules recited in claim 1, wherein the molecules comprise a nucleotide sequence of to any of SEQ ID NO: 1-6; or a nucleotide sequence with at least 99% sequence identity to SEQ ID NO: 3-6, 24, or 25. Applicant claims a soybean product produced from said plant, cell, part or seed; Applicant claims methods of using said plants and seeds.
Applicant teaches transforming soybean plants with a plasmid encoding an herbicide tolerance protein (a modified Pseudomonas fluorescens HPPD) and a nematode tolerance (Cry14Ab) protein (Example 1.1, on page 80). Applicant teaches following an extensive selection procedure to identify among the transformed plants the plants of elite event EE-GM5, wherein the plants of the event express the two resistance genes, have the resultant resistance, and comprise other desirable agronomic characteristics (Example 1.2.1 on pages 82-91). Applicant teaches identifying the sequences that comprise the event, including the sequence of the transgene and the regions of the soybean genome that flank the transgene at the 3’ and 5’ ends (Example 1.2.2. on pages 91-99). Applicant teaches that SEQ ID NO: 1 and 2 are 20-mers and SEQ ID NO: 3 and 4 are 40-mers that encompass the 3’ and 5’ portions of the inserted of the transgene, the junction, and the nucleotides representing the native sequences surrounding the transgene (see page 91 Sequence Listing on page 78). Applicant teaches that SEQ ID NO: 23 represents the full-length “event EE-GM5” and encompasses the transgene, the junctions, and the flanking regions of the soybean genome (see the description of the sequences on pages 78-79).
Applicant has not taught how to use a soybean plant comprising a fragment of event EE-GM5. For example, the claims encompass any soybean plant comprising a polynucleotide with only partial sequence identity to SEQ ID NO: 1 or 2. Given that SEQ ID NO: 1 and 2 are 20-mers, while one could make a soybean plant comprising said sequence, one would not be able to use it without substantial further trial and error experimentation. For example, a soybean plant comprising a 15- or 20-nucleotide long fragment of event EE-GM5 will not possess the herbicide and/or nematode tolerance conferred by the transgenes of the full-length event.
While the teachings of the specification do provide guidance for how to make and use the soybean plants and seeds comprising event EE-GM5 (see Examples 1 and 2), the specification appears silent as to how one would use a plant comprising only a short fragment of the DNA of the event, which fragment encompasses the junction region. While one of ordinary skill in the art could reasonably use said fragment itself, for example, as a primer or probe, it is unclear how one would use a plant comprising it.
Similarly, while the prior art discloses a soybean plant comprising a species of the genus of nucleic acid sequences encompassed by the claims, it appears silent with regard to any guidance that would enable one of ordinary skill in the art to use a plant comprising a short fragment of event EE-GM5, or any portion of the event smaller than the full-length.
Given limited guidance supplied by Applicant, the breadth of the claims and the nature of the invention, as well as the unpredictability in the art, it would have required one skilled in the art undue trial and error experimentation to practice the claimed invention.
Applicant argues that the amendments to the claims overcome the rejection (pages 10-11 of the Remarks). Applicant’s amendments are acknowledged and the rejection has been modified accordingly. However, the claims remain rejected as set forth in the modified rejection above.
Claim Rejections - 35 USC § 102
15. 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.
16. Claims 9, 17, 20, 63, and 65 remain rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al (US Patent Publication 20140296138) taken with the evidence of GenBank Accession Number XM_006589619 (Submitted on January 7, 2014).
This rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s arguments filed on December 3, 2025 have been fully considered by they are not persuasive.
The claims are drawn to a soybean plant, cell, plant part, or seed comprising a nucleic acid molecule comprising a nucleotide sequence of SEQ ID NO: 2, a commodity product obtained from said plant or seed, and methods of using said plant or seed. As set forth in the claim interpretation section above, the term “a nucleotide sequence of SEQ ID NO: 2” will encompass any portion of SEQ ID NO: 2.
Huang et al disclose soybean cultivar Williams 82 and disclose using said cultivar to obtain, via Agrobacterium-mediated transformation, transgenic plants (referred to as “transgenic events” in Huang et al; synonymous with “transformation events”) wherein the transgene encodes a nematocidal protein called Vip3 (Examples 2 and 3). Huang et al disclose growing the resultant resistant plants in a soybean field (paragraph 0031, 34). Huang et al disclose plant material, which refers to any plant part or “product of a plant” (paragraphs 0062 and 64).
GenBank Accession Number XM_006589619 provides evidence that soybean cultivar Williams 82 comprise a nucleic acid sequence having 94% sequence identity to nucleotides 1-17 of the instant SEQ ID NO: 2. Given that SEQ ID NO: 2 is a 20-mer, the sequence of GenBank Accession Number XM_006589619 will thus have 16/20 or 80% sequence identity over the entire length of SEQ ID NO: 2. The sequence alignment is set forth below.
Sequence ID: XM_006589619.3 Length: 3328
Related Information
Alignment statistics for match #1
Score
Expect
Identities
Gaps
Strand
26.3 bits(13)
18
16/17(94%)
0/17(0%)
Plus/Minus
Query 1 TTCCACTATCGCGTCCA 17
||||||||||| |||||
Sbjct 739 TTCCACTATCGTGTCCA 723
Given the evidence of said GenBank Accession Number and in view of the claim interpretation set forth above, the disclosure of Huang et al anticipates the limitations of the instant claims. The methods of Huang et al will read on those of the methods of the instant claims 63 and 65, in view of the above claim interpretation and given that the transgenic plants of Huang et al (still comprising the transgenic event encoding the nematocidal protein Vip3) will read on the soybean plant of the instant claim 9. The plant material will read on the soybean product of claims 17 and 18.
Applicant argues that the cited art does not disclose the elements of the instant claims (pages 11-12 of the Remarks).
Applicant’s argument is not found to be persuasive. Applicant merely concludes that the cited art does not disclose the nucleotide molecule of the instant claim 9. However, Applicant does not set forth any reasoning as to why, in view of the instant claim interpretation, the prior art does not disclose all of the limitations of the claimed nucleic acid. As set forth in the claim interpretation section above, the claim language, as instantly amended, would read on a partial sequence of any of the polynucleotides recited in claim 9. In view of this, the teachings of Huang et al, taken with the evidence of the teachings of GenBank Accession Number XM_006589619, anticipate all of the limitations of the instant claims.
Claim Rejections - 35 USC § 103
17. 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.
18. Claims 20, 21, and 64 remain rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (US Patent Publication 20140296138) taken with the evidence of GenBank Accession Number XM_006589619 (Submitted on January 7, 2014).
The claims are drawn to a method of producing a soybean product, including soybean meal, ground seeds, flour, or soybean flakes.
The teachings of Huang et al and GenBank Accession Number XM_006589619 are set forth above. In addition, Huang et al teach that Vip3A is active against SCN (Example 2) and teaches planting resistant plants in nematode infested fields (paragraph 0004).
Huang et al do not expressly teach a method of producing a soybean product; or a method for planting or sowing the resistant plant of their invention in a field containing nematodes, including SCN.
At the time of filing, it would have been prima facie obvious to one of ordinary skill in the art to modify the teachings of Huang et al and obtain a soybean food product, such as a meal or ground seeds, or flour, from the plants and seeds of Huang et al. It would have also been obvious to plant the seeds of the plants of Huang et al, in a field comprising nematode, including SCN, or their eggs.
Doing so would have been obvious given that soybean is a seed crop, given routine industry practice, and in view of the express suggestion of Huang et al.
Applicant argues that the claims depend from claim 9 which is patentable, and therefore, claims 20, 21, and 64 are patentable as well (page 12 of the Remarks).
Applicant’s argument is not found to be persuasive. For the reasons set forth in the anticipation rejection above, claim 9 remains anticipated by the disclosure of Huang. The limitations of claims 20, 21, and 64 would have been made obvious by further teachings of Huang et al, taken with the evidence of GenBank Accession Number XM_006589619.
Double Patenting
19. 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.
20. Claims 9, 17, 18, 20, 21, 25-27, 31, and 63-65 remain and claim 69 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-8, and 11-26 of copending Application No. 17/058,515. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the co-pending application are drawn to a soybean plant, plant part, cell, or seed comprising a nucleic acid molecule of SEQ ID NO: 1-6, 24, or 25, including wherein the nucleic acid molecule further comprises SEQ ID NO: 7 and 9. These are identical to the corresponding nucleic acid molecules of the instant claims 9 and 69, as they all originate from the same event EE-GM5. The claims of the co-pending application are drawn to methods of increasing yield and weed control, wherein the active steps of said method would make obvious the active steps of the methods of the instant claims. Obtaining a soybean product, as recited in the instant claims 17-21 would have been obvious as a matter of standard industry practice given that soybean is a seed crop.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant request that the rejection be held in abeyance until patentable subject matter is identified (page 12 of the Remarks). This is not found to be persuasive, as no claims are currently allowable and no terminal disclaimer has been filed. The rejection is maintained.
Conclusion
21. No claims are allowed.
22. THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
23. Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYKOLA V KOVALENKO whose telephone number is (571)272-6921. The examiner can normally be reached Mon.-Fri. 9:00-5:30 PST.
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/MYKOLA V. KOVALENKO/Primary Examiner, Art Unit 1662