DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s arguments, see pages 5-15, filed 18 May 2026, with respect to the rejection(s) of claim(s) 89-91, 94-97 under 35 USC§112, Nonstatutory Double Patenting, and 35USC§103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is deemed proper.
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.
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Claims 86-90, 94-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8, which depends from claim 1, of U.S. Patent No. 9,969,954. Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons:
Claim 1 of U.S. Patent No. 9,969,954 recites oil extracted from seeds selected from Brassica napus, Camelina sativa, and Arabidopsis thaliana, wherein the total fatty-acid content comprises oleic acid; palmitic acid and, optionally, myristic acid; LA and GLA; and ALA, DHA, SDA, EPA, DPA, and ETA. Claim 1 further requires palmitic acid at 2–16%, myristic acid below 1%, oleic acid at 1–30%, LA at 4–35%, GLA below 4%, ALA at 4–40%, total saturated fatty acids at 4–25%, and a total ω6:total ω3 ratio of 0.1–3. Claim 8 further requires SDA, ETA, EPA, DPA, and DHA each to be present and requires the sum of ETA, EPA, DPA, and DHA divided by the sum of SDA, ETA, EPA, DPA, and DHA to be at least 75%. See U.S. Patent No. 9,969,954, claims 1 and 8, cols. 371–372.
The disclosure of U.S. Patent No. 9,969,954 is relied upon only to construe the scope of patented claims 1 and 8 and to identify species expressly disclosed as falling within the patented oil genus, and is not treated as prior art. The specification may properly be consulted for this purpose when determining whether a species or subgenus claimed in the present application would have been an obvious variation of the genus claimed in the patent. MPEP § 804, subsection II.B.1.
Claim 86
Claim 86 is directed to an extracted Brassica napus or Camelina sativa seed oil having substantially the same fatty-acid components and substantially the same numerical ranges recited in patented claim 1. Claim 86 differs by selecting two of the three seed species recited in patented claim 1, narrowing the total ω6:total ω3 ratio from 0.1–3 to 0.1–1, not affirmatively requiring DHA, and calculating the recited conversion relationship without DHA.
These differences do not render claim 86 patentably distinct. Selecting Brassica napus and Camelina sativa from the three expressly recited alternatives of patented claim 1 constitutes selection of a finite, specifically identified subgenus. The claimed total ω6:total ω3 range of 0.1–1 is wholly encompassed by the 0.1–3 range of patented claim 1 and is expressly identified in the patent as a contemplated range for the claimed extracted oil. See U.S. Patent No. 9,969,954, col. 19, lines 1–16; col. 21, lines 40–45. Further, claim 86 employs “comprising” language and therefore does not exclude DHA, ETrA, or the additional fatty acids required by patented claim 1.
The patent also provides a specific B. napus oil species within the genus of claims 1 and 8 that demonstrates the claimed relationship. Table 16, seed 5, reports SDA at 2.8%, ETA at 7.6%, EPA at 1.5%, DPA at 1.8%, and DHA at 12.2%. The patented claim 8 ratio is therefore:
(7.6 + 1.5 + 1.8 + 12.2)/(2.8 + 7.6 + 1.5 + 1.8 + 12.2) = 23.1/25.9 ≈ 89.2%
which satisfies patented claim 8. When calculated according to pending claim 86, excluding DHA from both the numerator and denominator, the same disclosed oil provides:
(7.6 + 1.5 + 1.8)/(2.8 + 7.6 + 1.5 + 1.8) = 10.9/13.7 ≈ 79.6%
which satisfies the “at least 75%” limitation of claim 86. Table 16, seed 5, also reports palmitic acid at 4.0%, myristic acid at 0.1%, oleic acid at 27.4%, LA at 8.1%, GLA at 0.3%, and ALA at 26.4%, each within the ranges recited in claim 86. See U.S. Patent No. 9,969,954, Table 16, cols. 95–98.
Accordingly, a person of ordinary skill in the art, considering the oil genus defined by patented claims 1 and 8 and the specific B. napus species disclosed as falling within that genus, would have at once envisaged and found it obvious to claim the overlapping subgenus defined in claim 86. The selection of two expressly recited oilseed species, a nested ω6:ω3 range, and the same disclosed fatty-acid profile calculated without DHA represents an obvious variation of the patented oil and does not confer patentable distinction.
Claim 87
Claim 87 further requires GLA to be present at less than 3% of the total fatty-acid content. The patent expressly identifies GLA levels below 3%, below 2%, below 1%, and below 0.5% as embodiments of the extracted oil genus. See U.S. Patent No. 9,969,954, col. 20, lines 24–31. Table 16, seed 5, contains 0.3% GLA and therefore falls within claim 87. Selecting the expressly disclosed subrange below 3% would have been an obvious narrowing of the GLA range below 4% already required by patented claim 1, particularly where the record does not establish criticality or an unexpected result at the 3% boundary.
Claim 88
Claim 88 further requires C20:1 at less than 1% of the total fatty-acid content. The patent expressly identifies an embodiment of the extracted oil in which the total fatty-acid content has less than 1% C20:1. See U.S. Patent No. 9,969,954, col. 22, lines 3–5. The limitation therefore selects a specifically identified compositional species within the patented extracted-oil genus. A person of ordinary skill would have found it obvious to select that expressly disclosed low-C20:1 species while retaining the fatty-acid composition of patented claims 1 and 8, because the limitation merely narrows the amount of a minor fatty-acid component and no criticality or unexpected property attributable to the less-than-1% boundary has been shown. (Google Patents)
Claim 89
Claim 89 further requires the ratio of new ω6 fatty-acid content to new ω3 fatty-acid content to be less than 0.20. The patent expressly identifies new-ω6:new-ω3 ratios below 0.50, below 0.40, below 0.30, below 0.20, and below 0.15 as embodiments of the extracted lipid or oil. See U.S. Patent No. 9,969,954, col. 21, lines 46–52. The patent also defines “new ω6 fatty acids” as ω6 fatty acids excluding LA and “new ω3 fatty acids” as ω3 fatty acids excluding ALA. See id., definitions of total and new ω6 and ω3 fatty-acid contents.
Table 16, seed 5, contains approximately 0.4% new ω6 fatty acids and approximately 27.4% new ω3 fatty acids, producing a new-ω6:new-ω3 ratio of approximately 0.015, which is below 0.20. Thus, claim 89 encompasses an expressly disclosed species of the patented oil genus. Selection of the expressly identified ratio below 0.20 would have been an obvious narrowing and does not render claim 89 patentably distinct.
Claim 90
Claim 90 further requires the sum of SDA, ETA, EPA, and DPA divided by the sum of ALA, SDA, ETrA, ETA, EPA, and DPA to be at least 30%. The patent identifies this type of relationship as reflecting Δ6-desaturase conversion of ALA to SDA and downstream products and expressly identifies efficiencies of at least 30%, 40%, 50%, 60%, and 70%. See U.S. Patent No. 9,969,954, specification discussing Δ6-desaturase conversion efficiency; col. 65, lines 27–31.
Using the values reported for Table 16, seed 5, the relationship recited in claim 90 is: (2.8 + 7.6 + 1.5 + 1.8 /26.4 + 2.8 + 1.5 + 7.6 + 1.5 + 1.8) = 13.7/41.6 ≈ 32.9%.
The disclosed oil therefore satisfies the at-least-30% limitation of claim 90. Because claim 90 encompasses a specific oil species disclosed as falling within the patented genus and employs an expressly identified conversion threshold, the claimed subject matter would have been an obvious variation of patented claims 1 and 8.
Claims 94–97
Claim 94 further requires the extracted oil to comprise one or more sterols. Claim 95 specifies that the sterols comprise one or more or all of campesterol, Δ5-stigmasterol, eburicol, β-sitosterol, Δ5-avenasterol, Δ7-stigmasterol, and Δ7-avenasterol. Claim 96 requires less than 10 mg sterols/g oil, and claim 97 requires the oil to be essentially free of cholesterol.
The patent expressly identifies embodiments of the extracted oil in which the oil comprises one or more sterols, including one or more or all of campesterol, Δ5-stigmasterol, eburicol, β-sitosterol, Δ5-avenasterol, Δ7-stigmasterol, and Δ7-avenasterol; optionally comprises less than 10 mg sterols/g oil; and is essentially free of cholesterol. See U.S. Patent No. 9,969,954, col. 22, lines 23–31.
Patented claim 8 broadly encompasses extracted seed oil and does not exclude the minor non-fatty-acid constituents ordinarily remaining in the oil. The cited portion of the patent identifies a finite set of sterol-containing and purified-oil species falling within that claimed genus. A person of ordinary skill would have at once envisaged and found it obvious to select those expressly identified species while retaining the fatty-acid composition required by patented claims 1 and 8. The limitations of claims 94–97 merely select disclosed sterol constituents, a disclosed sterol concentration, and a disclosed cholesterol-purity condition, and the record does not establish that these selections produce a critical or unexpected result.
Accordingly, claims 86–90 and 94–97 are not patentably distinct from the invention defined by claims 1 and 8 of U.S. Patent No. 9,969,954. Allowing the pending claims in a separate patent would provide an unjustified extension of the right to exclude granted by U.S. Patent No. 9,969,954.
Allowable Subject Matter
Claim 91 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEBORAH D CARR whose telephone number is (571)272-0637. The examiner can normally be reached Monday-Friday (10:30 am -6:30 pm).
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/DEBORAH D CARR/ Primary Examiner, Art Unit 1691
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