DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 86-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 & 7 of U.S. Patent No. 8,816,111.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1 and 7 of U.S. Patent No. 8,816,111 recite plant lipid compositions comprising polyunsaturated fatty acids obtained from oilseed plants, forming the foundational oil composition claims of the patent family.
Claim 86 of the instant application is directed to the same general subject matter and differs only in numerical fatty-acid ranges and ratios. Claims 87–97 further narrow those compositions.
The pending claims therefore constitute obvious modifications of the claims of U.S. Patent No. 8,816,111 and are not patentably distinct.
Claims 86-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 9,550,718.
Claims 1–4 of U.S. Patent No. 9,550,718 recites extracted plant oils comprising polyunsaturated fatty acids, including omega-3 fatty acids, and define relative fatty-acid content and proportions.
Claim 86 of the instant application recites the same type of extracted plant seed oil and the same fatty-acid classes and differs only by specifying particular numerical ranges and ratios. Dependent claims 87–97 further limit the oil composition.
These differences represent routine narrowing of known compositions and do not confer patentable distinction. Therefore, claims 86–97 are rejected for obviousness-type double patenting.
Claims 86-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 104 of U.S. Patent No. 10,335,386.
Claims 1 and 10 of U.S. Patent No. 10,335,386 are directed to plant-derived lipid compositions enriched in omega-3 polyunsaturated fatty acids, including long-chain omega-3 fatty acids, obtained from Brassica or Camelina plants.
Claim 86 of the instant application recites an extracted seed oil from the same plant sources and comprising the same omega-3 fatty acids, differing only by quantitative compositional refinements. Claims 87–97 further narrow the same oil composition.
The pending claims are therefore obvious variants of the claims of U.S. Patent No. 10,335,386 and are not patentably distinct
5. Claims 86-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10,899,992.
Claims 1–5 of U.S. Patent No. 10,899,992 recites an extracted plant lipid comprising fatty acids in esterified form, including oleic acid, palmitic acid, linoleic acid (LA), α-linolenic acid (ALA), and one or more of SDA, ETA, EPA, and DPA, further defined by quantitative fatty-acid ranges and ratios.
Claim 86 of the instant application recites the same extracted plant seed oil compositions and the same classes of fatty acids, and differs only by specifying particular numerical ranges, ratios, and relative proportions that fall within or represent obvious variations of the ranges recited in U.S. Patent No. 10,899,992. Claims 87–97 further narrow these compositions.
Such differences amount to routine selection and optimization of fatty-acid compositions already claimed and do not render the claims patentably distinct. See In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003).
Accordingly, claims 86–97 are rejected for obviousness-type double patenting over U.S. Patent No. 10,899,992.
Claims 86-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, & 14 of U.S. Patent No. 11,834,621.
Claims 1, 2, and 14 of U.S. Patent No. 11,834,621 are directed to extracted plant lipid or seed oil compositions derived from oilseed plants, comprising omega-3 polyunsaturated fatty acids, including SDA, EPA, and DPA, within defined compositional ranges.
Independent claim 86 of the instant application is likewise directed to an extracted Brassica napus or Camelina sativa seed oil comprising the same omega-3 fatty acids and differs from the claims of U.S. Patent No. 11,834,621 only in the recitation of narrower numerical ranges, ratios, or compositional thresholds. Dependent claims 87–97 further limit these compositions by additional quantitative refinements.
The differences between the pending claims and the claims of U.S. Patent No. 11,834,621 constitute mere optimization or narrowing of known oil compositions, which would have been obvious to one of ordinary skill in the art. Accordingly, claims 86–97 are not patentably distinct.
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.
Claims 86-97 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 86 recites numerous independent fatty-acid ranges and ratios, including but not limited to:
Palmitic acid: 2–16%
Oleic acid: 1–30%
LA: 4–35%
ALA: 4–40%
ω6:ω3 ratio: 0.1–1
EPA/DPA dominance ratios ≥75%.
The specification does not disclose representative examples or species across the entire breadth of these combined ranges.
Absent disclosure of oils spanning the full combinatorial scope of these ranges, possession of the claimed genus is not established. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010).
Claims 92–93 require crude seed oil compositions comprising detectable nucleic acids encoding specific desaturases or elongases.
The specification fails to demonstrate:
That nucleic acids persist through oil extraction,
That such nucleic acids are present at reproducible or detectable levels, or
That crude oils containing nucleic acids are representative of the full claimed scope.
Accordingly, written description support for claims 92–93 is lacking.
The specification does not demonstrate possession of the full scope of the claimed oil compositions, particularly for claims defined by complex numerical relationships and biological remnants in extracted oil.
Claims 86-97 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.
Independent claim 86 defines an extracted Brassica napus or Camelina sativa seed oil by simultaneously requiring:
Presence of multiple omega-3 fatty acids (ALA, SDA, ETA, EPA, DPA);
Multiple independent numerical ranges, including:
Palmitic acid (2–16%);
Oleic acid (1–30%);
LA (4–35%);
ALA (4–40%);
Total saturated fatty acids (4–25%);
A global ω6:ω3 ratio of 0.1–1; and
A second-order dominance constraint, requiring that
> (ETA + EPA + DPA) ÷ (SDA + ETA + EPA + DPA) ≥ 75%.
The dependent claims (87–97) further impose:
Additional exclusionary thresholds (e.g., GLA <3–4%, C20:1 <1%);
Alternative ratio definitions using different fatty-acid subsets; and
Crude-oil embodiments purportedly containing detectable nucleic acids encoding specific enzymes.
Collectively, the claims define a high-dimensional compositional space governed by interdependent biochemical constraints.
1. Breadth of the Claims (Strongly Favors Non-Enablement)
The claims encompass thousands of distinct oil compositions, because:
Each fatty acid range varies independently,
Ratios constrain relationships, not absolute values, and
No single variable controls compliance—changing one fatty acid necessarily perturbs others.
The Federal Circuit has held that such combinatorial breadth weighs heavily against enablement when not matched by commensurate disclosure. See Amgen v. Sanofi; Wyeth v. Abbott, 720 F.3d 1380 (Fed. Cir. 2013).
2. Nature of the Invention (Unpredictable Art)
Plant fatty-acid biosynthesis—particularly production of long-chain omega-3 fatty acids (≥C20)—is:
Biologically complex, involving multiple competing enzymatic pathways;
Highly sensitive to gene choice, expression level, tissue specificity, developmental stage, and environmental conditions; and
Not linearly predictable, meaning small changes in pathway flux can cause large compositional shifts.
3. Amount of Guidance Provided (Insufficient)
The specification does not provide:
A generalizable framework for simultaneously satisfying all claimed ranges and ratios;
Predictive rules for how altering one fatty acid affects the others;
A step-by-step methodology for achieving the EPA/DPA dominance constraints while remaining within all other claimed bounds.
Instead, the disclosure relies on limited examples or generalized pathway descriptions, which do not scale to the full claim scope.
4. Presence or Absence of Working Examples (Insufficient)
While the specification may include examples of certain oil compositions, it does not:
Provide representative examples spanning the breadth of the claimed ranges;
Demonstrate oils near the edges of the claimed ratios (e.g., ω6:ω3 ≈ 0.1 or ≈ 1); or
Show multiple distinct compositions all satisfying the ≥75% EPA/DPA dominance requirement.
A small number of examples cannot enable a claim scope of this breadth.
5. State of the Prior Art (Does Not Cure the Deficiency)
Although the prior art teaches individual elements (e.g., producing EPA in plants), it does not teach:
How to reliably generate oils satisfying all claimed constraints simultaneously, or
How to predict which enzyme combinations and expression strategies will yield compliant oils.
Enablement cannot be supplied by trial-and-error screening across a large genus, even if the tools are known.
6. Amount of Experimentation Required (Undue)
To practice the full scope of the claims, a POSITA would need to:
Construct and test numerous transgenic plant lines;
Vary multiple enzymes, promoters, and gene copy numbers;
Grow and harvest plants under varying conditions;
Extract oils and perform compositional analysis for each line; and
Iteratively adjust constructs to converge on compliant compositions.
This constitutes extensive, iterative, and non-routine experimentation, not mere verification.
7. Predictability of the Results (Low)
The claims require achieving precise multi-parameter biochemical outcomes, yet:
The relationship between enzyme expression and final oil composition is non-deterministic;
No disclosure teaches how to predictably maintain compliance with all ratio constraints across plant backgrounds.
Low predictability further supports a finding of non-enablement.
Additional Enablement Defects (Claims 92–93)
Claims 92–93 require crude seed oil comprising nucleic acids encoding specific desaturases or elongases.
The specification does not enable this embodiment because it fails to teach:
Whether nucleic acids survive oil extraction at detectable levels;
What extraction methods preserve such nucleic acids;
How detection is performed or validated; or
Whether such crude oils are reproducibly obtainable across plant species.
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 86-97 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.
Independent claim 86 recites numerous fatty-acid components and ratios (e.g., “total ω6 fatty acid content,” “total ω3 fatty acid content,” “new ω6 fatty acid content,” “new ω3 fatty acid content”), however:
The term “new ω6 fatty acid content” and “new ω3 fatty acid content” (claims 89–90) is not defined in the claims or by a recognized meaning in the art.
It is unclear whether “new” refers to:
Newly synthesized fatty acids,
Fatty acids added post-extraction,
Fatty acids excluding native seed oil components, or
Some other subset of fatty acids.
Accordingly, the scope of claims 89–90 is ambiguous.
Claim 86 recites multiple ratios calculated from sums of fatty-acid percentages, including:
> “the sum of the percentages for ETA, EPA and DPA divided by the sum of the percentages for SDA, ETA, EPA and DPA”.
However, the claims do not specify:
Whether trace amounts below detection limits are included,
Whether fatty acids present at “0%” are included in the denominator, or
How rounding or analytical variability affects compliance.
Thus, the method of determining infringement is unclear, rendering the claims indefinite.
Claims 92–93 recite that the extracted seed oil is a “crude composition” comprising nucleic acids encoding desaturases or elongases.
The term “crude composition” lacks an objective boundary because:
No minimum or maximum purification level is recited,
No analytical threshold for nucleic acid presence is provided, and
The claims do not distinguish crude oil from partially refined oil.
As such, a person of ordinary skill in the art cannot determine the metes and bounds of the claims.
Because the claims contain unclear terminology, undefined parameters, and ambiguous calculation requirements, claims 86–97 fail to particularly point out and distinctly claim the invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 86-97 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2004/071467 (hereinafter WO’467) in view of Cirpus et al. (US 2009/0234006, hereinafter US’006).
WO’467 discloses:
Oilseed plants, expressly including Brassica species, genetically engineered to modify fatty-acid biosynthesis (¶¶ [0020], [0034], [0102]–[0106]);
Seed oils extracted from transformed plants (¶¶ [0015], [0040], [0128]);
Seed oil compositions comprising omega-3 fatty acids, including α-linolenic acid (ALA), stearidonic acid (SDA), eicosapentaenoic acid (EPA), and docosapentaenoic acid (DPA) (¶¶ [0008], [0012], [0056], [0061]);
Use of Δ6 desaturase to convert ALA to SDA, followed by elongase and desaturase activity to produce EPA and DPA (¶¶ [0058]–[0064]; Fig. 1); and
Oil compositions in which relative fatty-acid content is altered by pathway engineering in seed tissue (¶¶ [0067], [0071], [0129]).
Accordingly, WO’467 teaches extracted Brassica seed oil comprising ALA, SDA, EPA, and DPA in esterified form.
US’006 is directed to methods for producing EPA in transgenic plants and controlling fatty-acid composition in plant oils.US’006 discloses:
Introduction of heterologous desaturase and elongase genes into plants to produce EPA-containing seed oils (¶¶ [0002], [0010], [0048]);
That relative fatty-acid levels and ratios in plant oils are modifiable by enzyme selection, expression level, and pathway configuration (¶¶ [0023], [0031], [0055]); and
That achieving targeted fatty-acid compositions in seed oil was routine and predictable to one of ordinary skill in the art prior to 2012 (¶¶ [0060]–[0063]).
Claim 86 recites an extracted Brassica napus or Camelina sativa seed oil comprising fatty acids including ALA, SDA, ETA, EPA, and DPA, with: Defined omega-6 to omega-3 ratios, Limits on saturated fatty-acid content, and A requirement that EPA and DPA constitute a dominant portion of the omega-3 fatty acids. WO’467 teaches: Extracted seed oil from Brassica plants (¶¶ [0015], [0040], [0128]); Presence of ALA, conversion to SDA, and further conversion to EPA and DPA (¶¶ [0058]–[0064]; Fig. 1); and Seed oil compositions in which omega-3 fatty acids constitute a substantial fraction of total fatty acids (¶¶ [0067], [0129]). US’006 teaches that: Relative proportions of EPA and other fatty acids in plant oils are result-effective variables that can be predictably adjusted through known pathway engineering techniques (¶¶ [0023], [0031], [0055]). Thus, WO’467 in view of US’006 teaches or renders obvious all components of claim 86, with the claimed numerical ranges and ratios representing routine optimization of known fatty-acid composition variables. Claims 87–91 further limit claim 86 by specifying: Upper limits on GLA and C20:1, and Particular percentage relationships among SDA, ETA, EPA, and DPA. WO’467 teaches control over the presence and amounts of these fatty acids through enzyme selection and pathway design (¶¶ [0056]–[0064], [0067]), while US’006 teaches that adjusting enzyme combinations predictably alters relative fatty-acid percentages (¶¶ [0023], [0031]). Selection of specific upper or lower bounds for known fatty acids would have been an obvious matter of routine optimization. See In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003). Claims 92–93 recite that the extracted seed oil is a crude composition comprising nucleic acids encoding desaturases or elongases. WO’467 and US’006 both disclose transgenic plants expressing such nucleic acids (WO’467 ¶¶ [0034], [0102]; US’006 ¶¶ [0010], [0048]). Oil extracted prior to refining would inherently contain residual biological material, including nucleic acids. Accordingly, these limitations are inherent or obvious. Claims 94–97 further limit the oil by sterol content and by being essentially free of cholesterol. Plant seed oils are inherently cholesterol-free, and sterol content in plant oils is well known and routinely controlled by extraction and purification (WO’467 ¶ [0040]). These limitations would have been obvious design choices. One of ordinary skill in the art would have been motivated to combine WO’467 with US’006 to: Apply the known enzymatic pathway engineering techniques of US’006 to the oilseed platforms and omega-3 endpoints taught by WO’467; and Optimize fatty-acid ratios and dominance for nutritional and functional purposes. The combination represents the predictable use of prior art elements according to their established functions, with a reasonable expectation of success. See KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
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