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 1, 2, 4, 5-8, 11-18, and 20-26 are pending.
3. Claims 2, 5-7, 8, 11, and 12 remain withdrawn from consideration.
4. Claims 1, 4, 13-18, and 20-26 are examined herein.
5. The rejections under 35 U.S.C. 102 and 103 are withdrawn in view of Applicant’s amendments to the claims.
Election/Restrictions
6. Applicant's election with traverse of Group I, claims 1, 3-4, and 13-25, and accession number PI 88788 as species, in the reply filed on November 30, 2022 is acknowledged. In the previous Non-Final Office Action, the traversal was not found to be persuasive and therefore made FINAL.
Claims 2, 5-8, 11, and 12 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on November 30, 2022. Previously added claim 26 would have been included in the elected Group and, therefore, was examined.
Claim Objections
7. Claims 22, and 23 are objected to because they require an “and” before the last two members of the Markush groupings recited in each of the claims. Currently, claim 23 does not have a conjunction, and claim 22 have an “or” between the last two members of the Markush groupings.
In claim 21, line 3, the term “group” should be deleted.
Claims 15, 20 and 23 are objected to because the use of multiple identical letters in a row makes identifying the parts difficult, and because the use of periods in the numbering of subparts is improper. In a claim, periods can only be used in abbreviations or at the end of the sentence. See MPEP 608.01(m). Appropriate correction is required.
Applicant argues that the amendments to the claims overcome the objection (page 28 of the Remarks). This argument is not found to be persuasive. The objections have been modified in view of Applicant’s amendments, but the claims remain objected to for the reasons set forth above.
Claim Interpretation
8. As set forth below, the claims have been found indefinite. For the purposes of the examination, the following is noted with regard to claim interpretation. In claim 1, the recitation “the nucleotide sequence” that precedes the list of sequences, due to the use of the definite article “the” is read as requiring the full-length of the individual sequences recited in the alternative.
Claim 1 recites “wherein said soybean plant, cell, plant part, seed or progeny thereof is treated with one or more of the compounds.” It is noted that this product-by-process limitation does not require that the plant (or the cell, plant part, seed, or progeny) actually comprise any of the recited compounds.
Claims 13-18 are directed to plants, cells, plant parts or seeds of claim 1 “treated with” a nematicidal or a biological control agent. The term “treated with” is interpreted as a product-by-process limitation. See MPEP 2113. The claims are not drawn to a composition or combination comprising both, the plant, cell, or seed and a compound, and there’s no indication that the product-by-process term “treated” would reasonably imply any structural changes to the plant, cell or seed of claim 1. As a result, the claim is read as encompassing the plant limited solely by the presence of the nucleic acids recited in claim 1. The same reasoning applies to claims 20-23.
Moreover, claims 20-23 continue to recite the “soil in which they are grown or are intended to be grown” in the alternative with the plant, and since term “treated” does not require that the “soil” actually comprise any of the pesticides or other recited control agents (see MPEP 2113) the claims are given their broadest reasonable interpretation as encompassing any soil in which a soybean plant may be grown.
Claim 25 recites the location of the plant or seed of claim 1. In addition, the product-by-process term “treated” does not require that the soil actually comprise “compounds, agents, or mixtures.” As a result, the claim is interpreted as being limited to the plant with the structure set forth in claim 1.
Claim Rejections - 35 USC § 112(b) - Indefiniteness
9. 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.
10. Claims 1, 4, 13-18 and 20-26 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. The rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s arguments submitted on December 3, 2025 have been fully considered but they are not persuasive.
In claims 1, 21, and 22, the following names of pesticidal agents render the claims indefinite: “H1, H2, H3, H4, H5, IAN1, IAN2, IAN3, LAN4, LAN5, LAN6, LAN7, LAN8, LAN9, IAN10, IAN11, IAN12, IAN13, LAN14, IAN15, IAN16, IAN17, IAN18, IAN19, IAN20, IAN21, IAN22, IAN23, IAN24, IAN25, IAN26, IAN27, IAN28, IAN29, IAN30, SIAN1, F1, F2, F3, F4, 5, F6, F7, F8, F9, F9, F10, F11, F12, F13, F14, F15, F16, SF1, P1, BCA1, BCA2, BCA3, BCA4, BCAS, BCA6, BCAT, BCA8; BCA9, BCA10, NC1, NC2, NC3, SBCA1, SAT1, SC1 and SC2.” The designations do not appear to refer to any art recognized compound names such that one of ordinary skill in the art would be informed as to what compounds are encompassed. In addition, the specification provides no chemical structure or other information regarding the compounds. Moreover, in claim 1, the term “selected from groups” introduces further ambiguity into the claim language, because it is unclear what is meant by “groups,” given that the claim appears to refer to individual compounds.
In claim 21, as currently amended, the combination of the phrase “selected from the groups consisting of,” wherein the term “groups” is recited in plural and the phrasing of the individual combinations make it unclear which compounds or agents are meant to be included. MPEP 2117 explains that claim language defined by a Markush grouping requires selection from a closed group “consisting of” the alternative members. Yet some of the recited member contain the open-ended phrase “and other alkyl halides,” which would encompass any number of unenumerated compounds.
In claims 4 and 26, the term “PI 88788” renders the claims indefinite. The term is a common name for an SCN resistant soybean. However, since common name designations can and do change over time, and given that neither the claims nor the specification recite accession information for said variety, one of ordinary skill in the art would not be advised of the term’s metes and bounds. The same reasoning applies to all of the non-elected common soybean variety names recited in claim 4, including those referenced in Table 1. In addition, the reference to Table 1 is improper.
In claim 18, the names of bacterial strains using common name designations without corresponding deposit information render the claim indefinite. Such designations are arbitrary and can change over time. In addition, for some of the names, the claim appears to recite incomplete deposit numbers, such as “ATCC 64,” which introduces further ambiguity into the claim language.
In claim 24, in the list of the apparent “combinations” of transgenic events, it is unclear what is meant by the “x” between the names of the events. The metes and bounds of the claims are thus unclear. Given that claims 14, 16, 17, and 25 depend from claim 1, they are indefinite as well.
Response to Arguments
Applicant argues that the claims have been amended. With regard to the term “PI 88788,” in claims 4 and 26, Applicant reiterates the argument that one of ordinary skill in the art would be aware of their meaning. With regard to the apparently arbitrary names of compounds recited in claims 1, 21 and 22, Applicant cites a number of paragraphs in the Pre-Grant Publication and argues that the paragraphs “describe” the compounds (pages 29-30 of the Remarks).
Applicant’s amendments to the claims are acknowledged and the rejection has been modified accordingly. However, the claims, as instantly amended, remain rejected for the reasons set forth above.
Applicant’s argument with regard to the above two terms is not found to be persuasive because it is conclusive and does not address the reasoning on which the rejection is based. With regard to the arbitrary designations in claims 1, 21, and 22, the paragraphs Applicant cites merely provide examples of the actual compounds that may be encompassed. For example, paragraph 360 of the Pre-Grant Publication states “ F14: Compounds capable to act as an uncoupler, for example (14.001) fluazinam, (14.002) meptyldinocap.” The other cited paragraphs provide similar statements. This is not sufficient to set forth the metes and bounds of the claimed limitations at issue.
With regard to the term “PI 88788,” Applicant merely concludes that “a person skilled in the art would understand what this term means and implies, and there is no ambiguity regarding the use of this term” (page 30), but provides no reasons supporting that conclusion. The argument is thus not persuasive.
Claim Rejections - 35 USC § 112(d)
11. 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.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], 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.
12. Claims 13-18, 20-23, and 25 remain 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.
The rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s argument submitted on December 3, 2025 has been considered but it is not persuasive.
Claim 25 is directed to the plant, plant part or seed of claim 1, “wherein said plant part or seed are planted or sown in the soil treated with said compounds.” The recitation of the treatment of the soil in which a plant is grown does not limit the structure of the plant of claim 1, which structure is limited by the nucleic acid sequences recited in claim 1.
Claims 20-23 do not require the plant of claim 1: all these claims recite the plant, cell, plant part or seed in the alternative with the “the soil in which they are grown or intended to be grown.” For example, claim 13 is drawn to “The plant, cell, plant part or seed of claim 1, or the soil in which they are grown or are intended to be grown” (emphasis added). The claims thus encompass subject matter that is beyond the scope of the claim from which they depend.
Claims 13-18, as instantly amended, are directed to “The plant, cell, plant part or seed” or claim 1, treated with one or more of the recited compounds. The term “treated with” is interpreted as a product-by-process limitation. See MPEP 2113. The claims are not drawn to a composition or combination comprising both, the plant, cell, or seed and a compound, and there’s no indication that the product-by-process term “treated” would reasonably imply any structural changes to the plant, cell or seed of claim 1. For this reason, the claims fails to further limit the subject matter 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.
Response to Arguments
Applicant argues that the claims have been amended, and that reiterates the previously submitted argument that the dependent claims at issue “further define the elements of Claim 1 by further defining the compounds … used for the treatment” (page 31 of the Remarks)
Applicant’s argument is not found to be persuasive. The claim amendments are acknowledged, and the rejection has been modified accordingly; however, the amended claims remain rejected for the reasons set forth above. Applicant’s argument is not persuasive because it merely restates the subject matter to which the claims are directed, and fails to address the basis for the rejection, which is the failure to further limit the base claim. For example, claim 20 does not properly further limit the structure of the plants of claim 1, from which it depends because claim 20 recites “the soil” in the alternative with “the plant, cells, plant part or seed of claim 1.” For these reasons, the rejection is maintained.
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 1, 4, 13-18, and 20-26 remain 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.
The rejection has been modified in view of Applicant’s amendments to the claims. Applicant’s argument submitted on December 3, 2025 has been considered but it is 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 with at least 99% sequence identity to SEQ ID NO: 3, 4, 5, 6, 24, or 25; comprising any one of SEQ ID NO: 1-4 or their recited combinations; or comprising SEQ ID NO: 11 from position 188 to position 7101, or a nucleotide sequence having at least 98% to SEQ ID NO: 11 from position 188 to 7101; wherein any of the nucleic acid molecules further comprises SEQ ID NO: 7 and 9 or their complement, or the other sequences recited in parts (e)-(g) of claim 1.
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 251). 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 events express the two resistance genes, have the resultant resistance and comprise other desirable agronomic characteristics (Example 1.2.1 on pages 253-254). Applicant teaches identifying the sequences that comprise the nucleic acid sequence of the event, including the sequence of the transgene, and the regions of the soybean genome comprising the sequences that flank the transgene of the event at the 3’ and 5’ ends (Example 1.2.2. on pages 263-265). 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 249 and Sequence Listing). 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 page 250 and Sequence Listing). Applicant teaches that SEQ ID NO: 7 and 9 represent the coding portions of the transgene, wherein SEQ ID NO: 7 is the cry14Ab-1.b gene and SEQ ID NO: 9 is the hppdPf-4Pa gene (page 6, lines 5-15 of the specification).
Applicant does not teach how to use a soybean plant comprising a fragment of event EE-GM5. For example, the claims encompass a soybean plant comprising only SEQ ID NO: 3 (part (a) of claim 1) and SEQ ID NO: 1 (part (g) of claim 1). Applicant has not taught how to practice said plants. While one could make a soybean plant comprising SEQ ID NO: 1, a 20-mer, and SEQ ID NO: 3, a 40-mer, one would not be able to use it without substantial further trial and error experimentation. For example, a soybean plant comprising said short fragments of event EE-GM5 will not possess the herbicide and nematode tolerance conferred by the transgenes of the event. Similarly, Applicant has not taught how to use a soybean plant comprising a nucleotide sequence having 98% identity to SEQ ID NO: 11 from nucleotide position 188 to 7101.
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), it 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 probe for the event, 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 a plant comprising a nucleic acid sequence having 98% identity to a portion of event EE-GM5.
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.
Response to Arguments
Applicant argues that the claim amendments overcome the rejection (page 31 of the Remarks). This is not found to be persuasive. The amended claims remain rejected for the reasons set forth above.
The claims drawn to a non-elected invention remain withdrawn for the reasons set forth in the previous Office Action, and given the fact that no claims are currently allowable.
Double Patenting
15. 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.
16. Claims 1, 4, 13-18, and 20-26 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 9, 10, 12, and 13 of copending Application No. 18/058,537. 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. These are identical to the corresponding nucleic acid molecules of the instant claims as they all originate from the same event EE-GM5. For this reason, the claims of the co-pending application make obvious the instantly claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant requests that the rejections be held in abeyance until allowable subject matter is identified (page 34 of the Remarks). This is not found to be persuasive. No claims are currently allowable and no terminal disclaimer has been filed. The rejection is maintained.
Conclusion
17. No claims are allowed.
18. 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.
19. 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