Status of the Application
This Office Action is in response to the Amendment and Remarks filed 28 April 2026.
The Substitute Specification filed 28 April 2026 is approved by the Examiner, and overcomes the objections to the specification and addresses compliance with sequence disclosures.
The rejection under 35 USC 112(a) for lack of adequate written description is withdrawn in view of Applicant’s amendments to the claims.
The rejection under 35 USC 112(b) is now moot was the rejected claims have been cancelled.
The rejection for obviousness type double patenting over U.S. Patent 12,275,945 is withdrawn in view of Applicant’s amendments to the claims.
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.
Claim 20 is 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.
At claim 20, line 1, “the method of claim, wherein” renders the claim indefinite because it is unclear to which method the claim refers. Further, at line 2, “promoted, marketed or labeled with text”, especially promoted or marketed are mental steps and fail to set forth the metes and bounds of the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3, 8-10 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Winichayakul et al (2013, Plant Physiology 162: 626-639).
Winichayakul et al disclose modified oleosins that include at least one artificially introduced cystine in Figure 1 on page 628. Winichayakul et al disclose a plant genetically modified to express the modified oleosin “o1-3” containing four artificially introduced cystines and the triacylglycerol synthesizing enzyme DGAT1 (diacylglycerol O-acyltransferase) in Table 1 on page 629. Winichayakul et al disclose producing seed from the D1o3-3 plant on page 630, right column, 2nd paragraph. Winichayakul et al disclose planting the D1o3-3 plant in soil in Figure 3 on page 632. Hence, Winichayakul et al had previously disclosed the claimed invention.
See Integra LifeSciences I Ltd. V. Merck KGaA 50 USPQ2d 1846, 1850 (DC SCalif 1999), which teaches that where the prior art teaches all of the required steps to practice the claimed method and no additional manipulation is required to produce the claimed result, then the prior art anticipates the claimed method. Failure of those skilled in the art to contemporaneously recognize an inherent property, function or ingredient of a prior art reference does not preclude a finding of anticipation, Atlas Powder Co. v. IRECO, Inc., 190 F.3d 1342, 1349, 51 USPQ2d 1943, 1948 (Fed. Cir. 1999).
In the instant case, the claims are directed to an inherent property of the D1o3-3 plant without anything more. The inherent property includes the limitations of instant claims 8-10 because said claims do not recite anything more than what is disclosed by Winichayakul et al.
Applicant argues that the Office Action's rejection fails to account for the additional method steps now required by amended claim 1. Applicant argues that Winichayakul et al discloses gas-exchange analysis measuring rates of CO2 assimilation using an infrared gas analyzer. Applicant argues that Winichayakul et al further discloses that D1o3-3 plants were assimilating up to 24% more CO2 than wild-type plants, and that the elevated CO2 assimilation rate led to an approximately 50% increase in leaf biomass. Applicant argues that Winichayakul et al contains no disclosure of measuring, assessing, or comparing N20 production from soil. Applicant has confirmed that Winichayakul et al does not disclose N20 or nitrous oxide anywhere in the reference (pages 12-13 of the Remarks).
Applicant argues that amended claim 1 requires the step of "assessing the capability of the modified plant produced to reduce N20 production from the soil in which it is grown" by "comparing N20 production from the soil in which the modified plant is grown, to N20 production from the same soil in which a control plant is grown, and determining that N20 production from the soil in which the modified plant is grown is less than N20 production from the soil in which the control plant is grown." Applicant argues that these are affirmative method steps that must be disclosed in the prior art, not merely inherent properties of a plant. Applicant argues that the assessment step required by amended claim 1 is an active method step that must be performed. Winichayakul et al does not disclose performing any N20 measurements or comparisons (page 13, 2nd paragraph of the Remarks).
Applicant argues that amended claim 1 further requires "(c) selecting the plant based on this assessment in (b)." Applicant argues that Winichayakul et al does not disclose selecting plants based on any assessment of N20 production reduction capability. Applicant argues that the Office Action's inherency argument is inapplicable to the amended claims because while inherent properties may anticipate product claims, the amended method claims require active steps of assessing N20 production by comparing the modified plant to a control plant and selecting based on that assessment.
Applicant’s argument is not found persuasive because the assessing step does not materially or functionally change the “method of producing a plant that reduces N2O production from the soil in which it is grown” from that disclosed by Winichayakul et al. It would appear that one need only select a plant with increased triacylglycerol content to also select the product of the instantly claimed method.
Applicant argues that amended claim 3 recites "A method for reducing N20 production in soil, the method comprising growing in the soil a plant produced by the method of claim 1, expressing a modified oleosin including at least one artificially introduced cysteine in the N-terminal hydrophilic region and/or the C-terminal hydrophilic region, and at least one triacylglycerol (TAG) synthesizing enzyme; thereby reducing N20 production in soil." Applicant argues that because claim 3 depends from claim 1, and Winichayakul et al does not disclose the method of claim 1 for the reasons stated above, claim 3 is also not anticipated.
Applicant’s argument is not found persuasive because instant claim 3 is directed to a method of using the plant selected in the method of claim 1. The plant selected in Winichayakul et al is fully capable of meeting the functional requirement of the method of claim 3.
Applicant argues that Claims 8-10 depend from claim 1 and are allowable for the same reasons as claim 1. Applicant argues that new claims 17-19 depend from claim 3 and are allowable for the same reasons as claims 1 and 3. Applicant argues that new claim 20 recites 'A package containing seed from a plant made by the method of claim 1, wherein the package is promoted, marketed or labelled with text indicating" certain environmental benefits. Applicant argues that because claim 20 requires seed from a plant made by the method of claim 1, and Winichayakul et al does not disclose the method of claim 1, claim 20 is also not anticipated.
Applicant’s arguments are not found persuasive for the reasons given supra. Essentially the limitations of claims 8-10 and 17-19 are directed to desired results of using the selected seed produced by the method of claim 1 and do not actually structurally or functionally further limit the selected plant in claim 1.
The package containing a seed make by the method of claim [1] (as argued by Applicant) is not distinguishable from the seed disclosed by Winichayakul et al. Winichayakul et al disclose the seed on page 636, right column, last paragraph, as being stratified. Hence, it would appear that the seed were in “a package”.
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 e-Terminal Disclaimer may be filled out completely online using web-screens. An e-Terminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about e-Terminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3 and 8-10 remain rejected and 17-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 8,987,551. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘551 disclose a subgenus of the instantly claimed genus. Practicing the invention of the claims of the ‘551 would inherently practice the invention of the instant claims. Essentially the instantly claimed invention would give the Applicant an improper timewise extension of the “right to exclude” others from practicing the invention of the ‘551 Patent.
Applicant argues that the claims of the ‘551 patent do not recite any method steps directed to assessing N2O production from soil, comparing N2O production between modified plants and control plants or selecting plants based on N2O reduction capability (page 14, 4th paragraph of the Remarks).
Applicant’s argument is not found persuasive because the ‘551 Patent explicitly recites that the method produces an “increased nitrogen use efficiency” at claims 18 and 23. Instant claim 1 does not recite any specific or non-obvious “assessing” method.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID H KRUSE whose telephone number is (571) 272-0799. The examiner can normally be reached Monday-Friday 7AM-3:30PM.
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/David H Kruse/
Primary Examiner, Art Unit 1663
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