DETAILED ACTION
Notice of Pre-AIA or AIA Status
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
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-12
Withdrawn claims: None
Previously canceled claims: None
Newly canceled claims: None
Amended claims: None
New claims: None
Claims currently under consideration: 1-12
Currently rejected claims: 1-12
Allowed claims: None
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Sprague et al. (Sprague, M., Betancor, M. B., & Tocher, D. R. (2017). Microbial and genetically engineered oils as replacements for fish oil in aquaculture feeds. Biotechnology letters, 39(11), 1599-1609. https://doi.org/10.1007/s10529-017-2402-6) in view of Astwood et al. (US 2014/0275596 A, cited on the IDS filed on 17 June 2025).
Regarding claim 1, Sprague teaches that farmed fish are traditionally fed a diet consisting of fishmeal and fish oil, rich in omega-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFA) (Abstract). Sprague also teaches that the increase in global aquaculture production has resulted in a need for additional sources of n-3 LC-PUFA, and that microalgae and genetically engineered oilseed crops may be used in aquafeeds for farmed fish (Abstract). Sprague further teaches that microalgae are the primary producers of n-3 LC-PUFA in the aquatic environment, providing a continual supply of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), offering a natural way of increasing the supply of n-3 LC-PUFA for farmed fish (p. 1601, col. 1, ¶ 1). Sprague teaches that microalgae have already been used by the aquaculture industry to enrich feeds (i.e., as a nutritional supplement) and directly in formulated feeds for fish (Id.). Sprague teaches that Nannochloropsis has been investigated as a fishmeal replacement in salmon feeds (p. 1601, col. 1, ¶ 2). In this way, Sprague teaches a method comprising feeding to fish a nutritional supplement comprising omega 3 fatty acids, the source of which may be oil from microalgae such as Nannochloropsis.
Sprague does not discuss enhancing immune-resilience of fish to skin diseases and skin parasites, or that the nutritional supplement comprises a carrier oil, 22-30 wt.% omega 3 fatty acids and 8-20 wt.% omega 7 fatty acids.
However, Astwood teaches blended algal oil compositions comprising 0.5-99 wt.% omega 3 fatty acids (e.g., EPA), and 0.5-99% omega 7 fatty acids (e.g., palmitoleic acid) ([0007] – [0008]). DHA may also be present in an amount ranging from 0-99 wt.% ([0008]). Astwood further teaches that various algal species may be the source of the oil compositions, including Nannochlorposis ([0028]).
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the microalgae described in Sprague with the algal oil compositions of Astwood by simple substitution of one element for another to obtain predictable results. See MPEP § 2143(I)(B). First, Sprague teaches the base method of feeding to fish a diet consisting of fishmeal and fish oil rich in n-3 LC-PUFA, wherein the oil can be substituted with microalgae, which provide a continual supply of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), offering a natural way of increasing the supply of n-3 LC-PUFA for farmed fish. Astwood teaches blended algal oil compositions comprising 0.5-99 wt.% omega 3 fatty acids (e.g., EPA), and 0.5-99% omega 7 fatty acids (e.g., palmitoleic acid) ([0007] – [0008]). DHA may also be present in an amount ranging from 0-99 wt.% ([0008]). The substitution would give rise to the predictable result of supplying n-3 LC-PUFA for farmed fish. The algal oil of Astwood comprising the omega 3 and omega 7 fatty acids is seen as the claimed carrier oil. The instant specification provides, “The oil may be any edible oil, that is edible by a specific animal or group of animals. For example, the oil can be a vegetable oil, a fish oil and the like.” ([0016]). Algal oil is clearly edible by fish as disclosed by Sprague. The claimed ranges of 22-30 wt.% omega 3 fatty acids and 8-20 wt.% omega 7 fatty acids lie inside the disclosed ranges of 0.5-99 wt.% omega 3 fatty acids and 0.5-99% omega 7 fatty acids. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
It is also noted that Table 2 of the instant specification provides evidence that Nannochloropsis oil comprises 22 wt.% EPA and 11 wt.% omega 7 fatty acids ([0024]). Thus, natural Nannochloropsis oil meets the oil limitations of the present claim.
Regarding the phrase, “enhancing immune-resilience of fish to skin disease and skin parasites”, this is an intended result of the positively recited method step of feeding to fish the claimed nutritional supplement. Sprague as modified by Astwood teaches the claimed method step. When the method steps recited in the prior art reference are substantially identical to those of the claims, claimed properties of the resulting composition are presumed to be present in the composition of the prior art. The burden of proof shifts to the applicant to provide objective evidence (i.e., test data) to the contrary. See In re Best, 562, F.2d 1252, 1254, 195 USPQ 403, 433 (CCPA 1977). MPEP § 2112.01(I).
Therefore, where Sprague as modified by Astwood teaches the claimed method step, the claimed property of enhancing immune-resilience of fish to skin disease and skin parasites is presumed to be present.
Claim 1 is therefore rendered obvious.
Regarding claim 2, Sprague also teaches that Nannochloropsis has been investigated as a fishmeal replacement in salmon feeds (p. 1601, col. 1, ¶ 2), and therefore discloses Nannochloropsis as a suitable organism from which to derive ingredients for fish feeds. Astwood teaches that various algal species may be the source of the oil compositions, including Nannochlorposis ([0028]).
Furthermore, MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Since Sprague teaches that it was known to use Nannochloropsis oil in fish feeds and Astwood discloses that the claimed Nannochloropsis is a suitable organism to use as the source of the oil components, it would have been prima facie obvious to select Nannochloropsis oil as the carrier oil for the omega 3 and omega 7 fatty acid nutritional supplement of Sprague as modified by Astwood as described regarding claim 1.
Claim 2 is therefore rendered obvious.
Regarding claim 3, Sprague and Astwood teach the method of claim 1.
Sprague does not discuss that the omega 3 fatty acids in the nutritional supplement include a mixture of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) fatty acids, having ratios in the range of 1:10 to 10:1 wt.% EPA:DHA.
However, Astwood teaches blended algal oil compositions comprising 0.5-99 wt.% EPA, and 0.5-99% omega 7 fatty acids (e.g., palmitoleic acid) ([0007] – [0008]). DHA may also be present in an amount ranging from 0-99 wt.% ([0008]).
The disclosed ranges of 0.5-99 wt.% EPA and 0-99 wt.% DHA allow for ratios of EPA:DHA encompassing or lying inside the claimed range of 1:10 to 10:1. In a case where the claimed ranges overlap or lie inside ranges disclosed by the prior art, a prima facie case of obviousness exists, MPEP § 2144.05(I).
Therefore, where it would have been obvious to modify Sprague with Astwood as described regarding claim 1, the limitations of claim 3 are also rendered obvious.
Regarding claim 4, Sprague and Astwood teach the method of claim 1.
Sprague does not discuss that the carrier oil in the nutritional supplement is prepared by mixing a first carrier oil containing omega 3 fatty acids and a second carrier oil containing omega 7 fatty acids.
However, Astwood teaches, “a concentrated omega-3 EPA mixture is produced from algal oil or other sources” ([0037]), “a concentrated omega-7 POA mixture is produced from algal oil or other sources” ([0038]), and “the two concentrated mixtures are combined together in the desired proportion” ([0039]). Therefore, the claimed limitation is obvious.
Additionally, the limitation of claim 4 is a product-by-process limitation for producing the product that is used in the claimed method. The method as recited is “A method of enhancing immune-resilience of fish to skin diseases and skin parasites comprising feeding to a fish a nutritional supplement…”, and not a method of preparing a nutritional supplement. It is noted that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Further, “although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product”, In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir.1983). See MPEP 2113. Therefore, absent evidence of criticality regarding the presently claimed process and given that Sprague as modified by Astwood meets the requirements of the claimed composite, Sprague as modified by Astwood clearly meets the requirements of present claim 4.
Claim 4 is therefore rendered obvious.
Regarding claim 5, Sprague and Astwood teach the method of claim 4.
Sprague also teaches that the nutritional supplement further comprises fishmeal – Sprague teaches that farmed fish are traditionally fed a diet consisting of fishmeal and fish oil, rich in omega-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFA) (Abstract). In the broadest sense, this combination of fishmeal and fish oil can be considered a nutritional supplement. Furthermore, adding fishmeal to an oil composition, and adding more fishmeal to complete the diet is also an obvious way to prepare a diet. In such a case, the fraction of fishmeal first mixed with the oil would be considered a nutritional supplement.
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to add fishmeal to the algal oil composition of Sprague as modified by Astwood as described regarding claim 1 because Sprague teaches that farmed fish are traditionally fed a diet of fishmeal and n-3 LC-PUFAs. One of ordinary skill in the art would have had a reasonable expectation of arriving at the claimed invention because any portion of the fishmeal added to the supplemental oil is considered to be a nutritional supplement.
Claim 5 is therefore rendered obvious.
Regarding claim 11, Sprague and Astwood teach the method of claim 1.
The cited prior art does not discuss that the nutritional supplement is figured to enhance immune-resilience of fish against sea lice.
However, regarding the phrase, “wherein the nutritional supplement is configured to enhance immune-resilience of fish against sea lice”, this a recognition of a latent property of the nutritional supplement comprising amounts of omega 3 and omega 7 fatty acids. The phrase “configured to” does not convey any additional structure to the nutritional supplement.
MPEP § 2112.01(I) states, “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.”
Therefore, since Sprague as modified by Astwood teaches feeding to a fish a nutritional supplement comprising a carrier oil, 22-30 wt.% omega 3 fatty acids and 8-20 wt.% omega7 fatty acids, the property of enhancing immune-resilience of fish against sea lice is presumed to be present. That is, the nutritional supplement is presumed to be configured to enhance immune-resilience of fish against sea lice.
Claim 11 is therefore rendered obvious.
Regarding claim 12, Sprague also teaches that the step of feeding the nutritional supplement to fish comprises feeding to fish a fish feed composition containing the nutritional supplement – Sprague teaches that farmed fish are traditionally fed a diet consisting of fishmeal and fish oil, rich in omega-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFA) (Abstract). Sprague also teaches that the increase in global aquaculture production has resulted in a need for additional sources of n-3 LC-PUFA, and that microalgae and genetically engineered oilseed crops may be used in aquafeeds for farmed fish (Abstract). As such, the substitution of the microalgae described in Sprague with the algal oil compositions of Astwood as described regarding claim 1 results in feeding to fish a fish feed composition containing the nutritional supplement as claimed.
Therefore, where claim 1 is obvious, claim 12 is obvious for the same reasons.
Claims 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Sprague et al. in view of Astwood et al. as applied to claim 5 above, and further in view of Odom et al. (US 2012/0183668 A1, cited on the IDS filed on 17 June 2025).
Regarding claim 6, Sprague and Astwood teach the method of claim 5.
Sprague teaches that farmed fish are traditionally fed a diet consisting of fishmeal and fish oil, rich in omega-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFA) (Abstract).
The cited prior art does not discuss that the step of feeding the nutritional supplement to fish comprises feeding to fish a ready-to-use diet for fish containing the nutritional supplement, wherein the fishmeal includes a mixture comprising protein and carbohydrates.
However, Odom discloses a ready to use diet for fish (p. 17, Table 4, Standard Feed), comprising fishmeal as the major meal component, as well as extracted sunflower meal, soybean meal and wheat (p. 17, Table 4, Standard Feed). While fishmeal is known to comprise mainly protein and fat and very little carbohydrate, the claim recites, “wherein the fishmeal includes a mixture comprising protein and carbohydrates”. It is therefore construed that the claimed “fishmeal” component of the ready-to-use diet is a mixture of fishmeal and other proteins and carbohydrates. The components of the standard diet of Odom meet this limitation.
It would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Sprague as modified by Astwood with the teachings of Odom to feed to fish a ready-to-use diet for fish containing the nutritional supplement and fishmeal wherein the fishmeal includes a mixture comprising protein and carbohydrates in the form of fishmeal, sunflower meal, soybean meal and wheat as taught by Odom. One of ordinary skill in the art would have been motivated to do so in order to provide all of the necessary nutrients to the fish, and to simplify feeding by using an all-in-one/ready-to-use composition. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Odom teaches a formulated “Standard Diet” comprising a fishmeal mixture containing proteins and carbohydrates, as well as a fish oil component, which is substituted with microalgae oil as described regarding claim 1.
Claim 6 is therefore rendered obvious.
Regarding claim 7, Sprague, Astwood, and Odom teach the method of claim 6.
Sprague does not discuss that the ready-to-use diet for fish containing the nutritional supplement comprises 0.7-7.5 wt.% omega 3 fatty acids and 2.0-7.7 wt.% omega 7 fatty acids.
However, Odom teaches a ready to use diet for fish (p. 17, Table 4, Standard Feed), comprising:
0.7-7.5 wt.% Omega 3 fatty acids – 1.0% 18:3, n-3 + 0.2% 18:4, n-3 + 0.2% 20:3, n-3 + 5.1 % 20:5, n-3 (EPA ([0211)) + 0.6% 22:5, n-3 + 5.2% 22:6, n-3 (DHA ([0211])) = 12.3% Omega-3 fatty acids in the crude fat component ([0211] and p. 17, Table 5, Standard Feed). 31.1% Crude fat (p. 17, Table 4, Standard Feed) x 12.3% Omega-3 fatty acids = 3.8% Omega-3 fatty acids in the feed composition.
2.0-7.7 wt.% Omega 7 fatty acids – 4.1% 16:1, n-7 + 1.6% 18:1, n-7 + 0.4% 22:1, n-7 = 6.1% Omega-7 in the crude fat component ([0211] and p. 17, Table 5, Standard Feed). 31.1% Crude fat (p. 17, Table 4, Standard Feed) x 6.1% Omega-7 fatty acids = 1.9% Omega-7 fatty acids in the feed composition. While the disclosed amount lies outside the claimed range, 1.9% is close enough to 2.0% to render the claimed limitation obvious, absent any evidence of criticality of 2.0 wt.% Omega-7 fatty acids. See MPEP § 2131.03(III).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Sprague as modified by Astwood with the teachings of Odom formulate the ready-to-use diet with 3.8 wt.% omega-3 and 1.9 wt.% omega-7 fatty acid concentrations as taught by Odom with the motivation to provide the food with a standard nutrient profile to support healthy fish. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because the omega 3 fatty acid amount of 3.8% lies inside the claimed range of 0.7-7.5 wt.% and the omega 7 fatty acid amount of 1.9% is sufficiently specific to the claimed range of 2.0-7.7 wt.%.
Claim 7 is therefore rendered obvious.
Regarding claim 8, Sprague, Astwood, and Odom teach the method of claim 6.
Sprague does not discuss that the ready-to-use diet for fish containing the nutritional supplement comprises 5-50 wt.% protein, 5-50 wt.% carbohydrates and 0.2-30 wt.% oil of the total weight.
However, However, Odom teaches a ready to use diet for fish (p. 17, Table 4, Standard Feed), comprising:
5-50 wt.% protein – 37.5% crude protein (p. 17, Table 4, Standard Feed “Chemical composition, %”)
5-50 wt.% carbohydrate – Odom indicates wheat, sunflower meal, corn gluten, and soybean meal as including carbohydrates ([0088]). Therefore, at least part of 13.5% wheat, 11.7% sunflower meal, 9.0% corn gluten, and 4.0% soybean meal represent the carbohydrates (p. 17, Table 4, Standard Feed). Even assuming that the entirety of these components is carbohydrates, this amounts in at most 38.2% carbohydrates. This amount lies inside the claimed range of 5-50 wt.%. Additionally, the chemical composition of the standard feed is 93.6% dry matter, comprising 31.1% crude fat, 37.5% crude protein, and 5.2% ash (p. 17, Table 4, Standard Feed “Chemical composition, %”). The majority of the remainder of the dry matter would be carbohydrates. This amounts to 19.8%, which also lies inside the claimed range of 5-50 wt.%.
0.2- 30 wt.% oil – 31.1% crude fat (p. 17, Table 4, Standard Feed “Chemical composition, %”)
While the disclosed amount lies outside the claimed range, crude fat would include any solid fat (i.e., non-oil fats), and even so 31.1% is close enough to 30% to render the claimed limitation obvious, absent any evidence of criticality of 30 wt.% oil. See MPEP § 2131.03(III).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the method of Sprague as modified by Astwood with the teachings of Odom formulate the ready-to-use diet with 37.5 wt.% protein, about 19.8 wt.% carbohydrates, and about 31.1 wt.% oil as taught by Odom with the motivation to provide the food with a standard nutrient profile to support healthy fish. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because the disclosed amounts of these macromolecules in the standard feed composition are within or are sufficiently specific to the claimed ranges.
Claim 8 is therefore rendered obvious.
Regarding claim 9, Sprague, Astwood, and Odom teach the method of claim 6.
Sprague also teaches that the carrier oil comprises fish oil and that the protein comprises animal byproducts – Sprague teaches that farmed fish are traditionally fed a diet consisting of fishmeal and fish oil, rich in omega-3 long-chain polyunsaturated fatty acids (n-3 LC-PUFA) (Abstract). Therefore, a suitable carrier oil for the claimed nutritional supplement would be fish oil. Where Sprague teaches fishmeal, and fishmeal is an animal byproduct, Sprague also teaches that the protein comprises animal byproducts.
Claim 9 is therefore rendered obvious.
Regarding claim 10, Sprague, Astwood, and Odom teach the method of claim 6.
Sprague also teaches that the carrier oil comprises oil rapeseed – Sprague discloses multiple genetically modified canola (i.e., rapeseed) oils, including a DHA-rich canola, and that such oils may have utility in aquafeeds being enriched in n-3 LC-PUFAs (p. 1605, col. 2, ¶ 3 – p. 1606, col. 1, ¶ 1).
Therefore, it would have been obvious for one of ordinary skill in the art, before the effective filing date of the claimed invention, to use a DHA-rich canola oil as the carrier oil in the nutritional supplement with the motivation of supplying a non-fish source for additional n-3 LC-PUFAs in the form of DHA. One of ordinary skill in the art would have had a reasonable expectation of success in arriving at the claimed invention because Sprague teaches that such canola oils are suitable for aquafeed applications.
Claim 10 is therefore rendered obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James Shellhammer whose telephone number is (703) 756-5525. The examiner can normally be reached Monday - Thursday 7:30 am - 5:00 pm ET.
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
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