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 Action/Claims
Receipt of Remarks/Amendments filed on 2/13/2026 is acknowledged. Claims 1-7 and 22-31 are pending and are presented for examination on the merits for patentability. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Maintained Rejections/Objections
New Matter
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 1-7 and 22-31 are 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.
Claims 1 and 22 recite wherein the fermented soy protein has a protein content of at least 55% and claim 25 recites wherein the fermented soybean protein has a protein content of about 70%. The specification discloses the composition contains at least 55% protein content. The term “soy protein” refers to a protein found in soybeans. Commercial sources of soy protein are generally available in a variety of different forms that vary in their composition and protein content. In general, soy protein products contain between 30-70% protein. (para 0014 and 0062 of specification). However, the specification do not disclose specifically the fermented soy protein (not the composition or soy protein products) has a protein content of at least 55%. Therefore, the recitation wherein the fermented soy protein has a protein content of at least 55% (claims 1 and 22) and wherein the fermented soybean protein has a protein content of about 70% (claim 25) represent new matter.
Further, claims 1 and 22 recite the composition consists essentially of fermented soybean protein. The instant specification in the background section disclose that soy protein has been added to aquafeeds in many forms whereby raw bean meal is processed using multiple methods, including but not limited to, heat treatments, solvent extraction, and microbial fermentation (para 0004). While the specification in the background section disclose soybean is known to be processed using multiple methods, including fermentation, the specification do not disclose that the composition of the present application includes fermented soybean protein. Therefore, the limitations in the instant claims which recite fermented soybean protein also represent new matter.
Response to Arguments
Applicant argued Paragraph [0062] of the specification expressly incorporates by reference in its entirety U.S. Publication No. 2013/0142905. Pursuant to MPEP § 608.01(p), material incorporated by reference is considered part of the disclosure of the application as filed. U.S. Publication No. 2013/0142905 expressly discloses soy protein having at least 55% protein content, including at paragraphs [0011] and [0017].
In response, U.S. Publication No. 2013/0142905 (‘905) discloses the composition contains at least 55% protein in para 0011 and 0017. This is similar to the instant specification which also recites the composition contains at least 55% protein. Claim 1 recites “wherein the soy protein has a protein content of at least 55%”, however, neither the specification nor the disclosure of ‘905 disclose specifically the soy protein (not the composition or soy protein products) has a protein content of at least 55%. Therefore, the recitation “wherein the soy protein has a protein content of at least 55%” represents new matter.
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.
Claims 1-7 and 22-31 are 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.
Claims 1 and 22 recite wherein the fermented soy protein has a protein content of at least 55% and claim 25 recites wherein the fermented soybean protein has a protein content of about 70%. The instant specification disclose the term “soy protein” refers to a protein found in soybeans (para 0062), which suggests that the “soy protein” would have a protein content of 100% since soy protein is the protein. Also, a product (e.g. soy meal) which contains soy protein would have a certain percent of soy protein included and does not necessarily have to have 100% soy protein, however, “soy protein” is protein and would necessarily have 100% protein. Thus, it is unclear what the other 45% (claims 1 and 22) or 30% (claim 25) of soy protein is if soy protein does not have 100% protein content.
Claims 2-7, 23-24, 26-31 are included in the rejection as they depend on a rejected base claim and do not clarify the issues discussed above.
Response to Arguments
Applicant argued in paragraph [0062] of the specification, the term "soy protein" refers to commercial soy protein products, which are expressly disclosed as varying in composition and protein content depending on post-harvest processing. Paragraph [0062] further states that soy protein products generally contain between 30-70% protein, with the remainder comprising non- protein components inherent to such commercial products. In view of this express disclosure, a person of ordinary skill in the art would readily understand that the claimed "soy protein having a protein content of at least 55%" refers to a commercially available soy protein product having a protein fraction of at least 55%, not to a purified protein having 100% protein content.
In response, the instant specification discloses the composition contains at least 55% protein content. The term “soy protein” refers to a protein found in soybeans. Commercial sources of soy protein are generally available in a variety of different forms that vary in their composition and protein content. In general, soy protein products contain between 30-70% protein. (para 0014 and 0062 of specification). Contrary to applicant’s argument, nowhere in the specification is it clearly defined that the term “soy protein” refers to a commercial soy protein products. The specification suggest that the soy protein product contains protein but there is no clear definition that “soy protein” refers to / or is the same as a soy protein product. As discussed supra, the instant specification disclose the term “soy protein” refers to a protein found in soybeans (para 0062), which suggests that the “soy protein” would have a protein content of 100% since soy protein is the protein. Thus, it remains unclear what the other 45% of soy protein is if soy protein does not have 100% protein content.
Claim Rejections - 35 USC § 103
The following is a quotation of 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 of this title, 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 negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1-7 and 22-30 are rejected under 35 U.S.C. 103(a) as being unpatentable over AKSNES (US2012/0004157A1; Jan. 5, 2012) in view of SWEENEY, M. P. (U. S. Patent No. 3,916,832), MIYOTA et al. (U. S. PG-Pub. No. 2005/0142248 A1) and Yamamoto et al. (Aquaculture, 309 (2010)173-180).
Aksnes throughout the reference teaches feed compositions for promoting growth of fish and for treating/ameliorating disorders such as enteritis (referred to as inflammation of the intestine) (Abstract; Para 0019). Aksnes teaches fish meal has traditionally been used for fish feed but in order to support a growing global farming of fish, there is an interest in replacing marine sources with plant protein sources (e.g., soy bean protein) (para 0006). Aksnes teaches enteritis occurring in soy protein fed fish (para 0293) and wherein the fish type include Salmonidae fish, and particularly wherein the fish is Atlantic Salmon and trout. (0012; 0219; 0041; 0010-0011; 0350; 0220).
Aksnes teaches the fish feed composition comprising hydroxproline and particularly bone meal from animals (i.e., animal by-product) wherein bone meal from animals contain hydroxyproline. (para 0031; 0053). Thus, the composition comprising bone meal which contains hydroxyproline reads on the animal by-product recited in the claims. The composition further comprise soy bean protein and astaxanthin (i.e., antioxidant) (para 0334-0335; 0053; 0097). Aksnes also teaches including macronutrients (e.g., vitamins such as vitamin A, D and K) necessary for optimal growth and health of fish. Aksnes also particularly teaches macro-minerals which include sodium, chloride, potassium and phosphorous. (para 0047; 0062-0066). Aksnes also teaches including gelatinized starch as a binder in the composition (para 0193;0195). The amount of astaxanthin in the composition can range from 0.05-0.06% (500-600 ppm) (para 0097), which falls within the amount recited in the instant claims. Aksnes discloses the feed composition is provided in the form of crumbles (for small fish) and pellets (for large fish) (para 0078). In addition, Aksnes also teaches the composition taught provides a growth promoting effect on final weight and weight gain (see: Fig. 4; Para 0012). Aksnes teaches in one embodiment of the present invention the one or more protein sources comprise between 5 and 95% of the feed, such as between 10 and 90%, such as between 15 and 80%, such as between 20 and 75% such as between 25 and 70%, such as between 30 and 65%, such as between 35 and 60%, such as between 40 and 55%, such as between 45 and 50%, or between 30 and 50%, such as between 35 and 45% such as around 40%, or such as between 50 and 70%, such as between 55 and 65% such as around 60% of the feed composition. (para 0154).
Aksnes further teaches a method of providing the fish the fish feed composition (claims; examples 1-6). Aksnes teaches the fish feed composition can be used for feeding fish at any feeding rate and by any feeding method. Feeding rates and frequencies are in part a function of fish size. Small larval fish and fry need to be fed a high protein diet frequently. As fish grow, feeding rate and frequencies should be lowered. (para 0205-0207).
The teachings of Aksnes have been set forth above.
As discussed supra, Aksnes teaches the method step of providing Salmonidae fish the fish feed composition wherein the composition can be used for feeding fish at any feeding rate and by any feeding method and wherein feeding rates and frequencies are in part a function of fish size. However, Aksnes does not expressly teach the method step of providing the composition to fry fish for a period of time beginning when said fry fish is first fed by mouth until said fry fish is reared for at least 30 days or a longer feeding period (i.e., 100 to 365 days) and wherein the composition is provided to the fish until fish achieves a market size weight (e.g., 1 to 12 pounds). Aksnes also does not expressly teach wherein the composition further includes nut-meal and fermented soybean protein. However, Sweeney, Miyota and Yamamoto cure these deficiencies.
SWEENEY teaches a method of aquaculture of a carnivorous aquatic fish species in a generally enclosed body of water, wherein the fish species is the young of carnivorous fish species, i.e. Atlantic salmon (see: col. 32, claims 1-3).
SWEENEY teaches the process which Atlantic salmon eggs are fertilized and hatched. Then the fry (the young Atlantic salmon) will commence feeding for a period of two years, wherein the salmon crop are grown to produce mature size of optimum marketable weight, i.e. about 8 pounds and then harvested (see: col. 11, line 61-63; & col. 20, line 44-56). As such, SWEENEY’s process, as discussed supra, reads on the step of providing the fish feed to a fry salmonidae fish, and also implicitly suggested the fry salmonidae fish is fed after the fish begins feeding by mouth because it is obvious that the fish can begin to eat foods after it has hatched and has a mouth to eat.
SWEENEY’s teaching also reads on feeding the salmonidae fish for at least 30 days and a period of 100-365 days because the period of “two years” would encompass the period of at least 30 days, or the period for 100-365 days as claimed.
The teaching of SWEENEY also reads on feeding the fish until the fish achieve a market size because the harvested marketable weight “about 8 pounds” taught by SWEENEY is encompassed by the size weight of “about 1 to about 12 pounds”.
The other reference MIYOTA teaches a fish-farming feed which is useful for feeding fish, i.e. salmon (see page 1: [0007]; and page 2: [0021]), comprising vitamin C for stabilizing the feed and additional ingredients that are used in conventional fish-farming feeds, i.e. cereal (e.g. soybean), oil cake meals (e.g. peanut oil meal, palm nut oil meal) which reads on nut-meal recited in instant claims, animal feeds (e.g. fish meal, meat meal, meat-and-bone meal, blood meal) (see page 4: [0054-0059]); and vitamins and minerals (e.g. sodium chloride, potassium chloride, magnesium carbonate (see page 4: [0060]).
Aksnes does not teach the soybean protein is fermented soybean protein. However, Yamamoto cures this deficiency.
Yamamoto teaches influence of fermentation conditions for soybean meal in a non-fish meal diet on the growth performance and physiological condition of rainbow trout. Yamamoto teaches fermented soybean meal fed to rainbow trout was superior to non-fermented soybean meal in that fermentation improved the nutritive value of soybean meal. Yamamoto teaches the protein content of fermented soybean meal being 44%. (see: table 2, introduction, discussion).
It would have been obvious to a person of ordinary skilled in the art at the time the invention was made to follow Aksnes teaching and to feed the fry fish with the fish feed comprising ingredients, e.g., fermented soybean protein and astaxanthin, because Aksnes teaches that said fish feed is effective to prevent inflammatory condition (e.g., enteritis) in fish, and it can be provided to any fish which is susceptible to plant-induced enteritis (i.e. soybean protein induced enteritis), especially the family Salmonidae fish.
It would have been obvious to a person of ordinary skilled in the art at the time the invention was made to combine Aksnes and SWEENEY because Aksnes teaches the fish feed composition can be used for feeding fish at any feeding rate and by any feeding method and SWEENEY suggests a process which is useful for farming young salmon fish, wherein the fry (young) salmon fish, after it has hatched, will commence feeding for a period of suitable time until the salmon fish grow to a desirable market weight, i.e. about 8 pounds, and such suggestion provides the motivation for one ordinary skill in the art to do so.
With respect to feeding the salmon fish by mouth as the manner recited, it would have been obvious to a person of ordinary skilled in the art at the time the invention was made to feed the fish by mouth because fish naturally eats food with their mouth.
It would have been obvious to a person of ordinary skill in the art to feed the fish until the fish to achieve the desirable size, i.e. about 8 pounds, because SWEENEY suggests that when the salmon crop are grown to the size such as about 8 pounds, they can be harvested, and such teaching implicitly suggested that such size is marketable. Further, a skilled person in the art would have the capability and knowledge to modify the growing and harvest period to produce a smaller or larger size salmon fish, if smaller or larger size fish is desirable. As such, SWEENEY’s teaching is sufficient to establish a prima facie case of obviousness.
It would have been obvious to a person of ordinary skilled in the art at the time the invention was made to incorporate additional and useful fish feed ingredients, i.e. nut meal, into Aksnes fish feed because the reference MIYOTA teaches that nut oil meals are common and useful ingredients added into the conventional fish-farming feed for feeding fish, i.e. salmon. Such teaching provides the motivation for one ordinary skill in the art to include these useful ingredients into their fish feed composition for feeding salmon fish, if they are desirable, as suggested by MIYOTA.
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to have combined the teachings of Aksnes and Yamamoto and include fermented soybean protein into Aksnes’s composition because Yamamoto teaches fermented soybean meal fed to rainbow trout was superior to non-fermented soybean meal in that fermentation improved the nutritive value of soybean meal.
With respect to the claimed limitations wherein the claimed composition provides equal or greater length, weight, survivability and growth rate of the fish when compared to a corresponding soy protein free composition, the prior art teaches composition which reads on consisting of language and teaches the same components recited in the instant claims. Thus, the composition of the prior art would necessarily result in equal or greater length, weight, survivability and growth rate of the fish when compared to a corresponding soy protein free composition. In addition, as discussed supra, Aksnes also teaches the composition taught provides a growth promoting effect on final weight and weight gain (see: Fig. 4; Para 0012).
With respect to the amount/concentration of soy protein in the composition, as discussed supra, Aksnes teaches the composition comprise soy bean protein. Aksnes teaches in one embodiment of the present invention the one or more protein sources comprise between 5 and 95% of the feed, such as between 10 and 90%, such as between 15 and 80%, such as between 20 and 75% such as between 25 and 70%, such as between 30 and 65%, such as between 35 and 60%, such as between 40 and 55%, such as between 45 and 50%, or between 30 and 50%, such as between 35 and 45% such as around 40%, or such as between 50 and 70%, such as between 55 and 65% such as around 60% of the feed composition. Aksnes teaches the composition for growth in fish and the natural fish prey for carnivorous fish such as salmonoids has 10-90 wt% of protein. Protein requirements usually are lower for herbivorous fish (plant eating) and omnivorous fish (plant-animal eaters) than they are for carnivorous (flesh-eating) fish, and are higher for fish reared in high density (recirculating aquaculture) than low density (pond aquaculture) systems. Protein requirements generally are higher for smaller fish. As fish grow larger, their protein requirements usually decrease. In one embodiment the fish feed composition comprises from 40 to 80% of protein. (para 0041; 0047; 0050-52; 0101; 0154). Therefore, absence any unexpected effect, it would have been obvious to one skilled in the art to manipulate the amount of soy protein in the composition and determine and optimal amount based on the factors/parameters disclosed by Aksnes which affect the amount of protein required by the fish. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Further, the combined references teach the composition comprising fermented soy protein which would necessarily have a protein content of 100%.
With respect to the ratio of fermented soybean protein and astaxanthin, it would have been obvious to one skilled in the art to manipulate the amount of soybean protein and the ratio of soybean protein to astaxanthin based on the protein requirement of the fish, which would depend on, for example, the size of the fish. Therefore, absence a criticality, the determination of an optimal ratio/amount of soy protein and astaxanthin would have been obvious to one skilled in the art. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
From the teaching of the references, one of ordinary skill in the art would have had a reasonable expectation of success to arrive at the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Claim 31 is rejected under 35 U.S.C. 103(a) as being unpatentable over AKSNES (US2012/0004157A1; Jan. 5, 2012) in view of SWEENEY, M. P. (U. S. Patent No. 3,916,832), MIYOTA et al. (U. S. PG-Pub. No. 2005/0142248 A1) and Yamamoto et al. (Aquaculture, 309 (2010)173-180) as applied to claims 1-7 and 22-30 above and further in view of Leigh et al. (US 2008/0311267 A1; 2008).
The teachings of above cited references have been set forth above.
Aksnes does not teach wherein the astaxanthin is dispersed in or top-dressed onto the fermented soybean protein. However, this deficiency is cured by Leigh.
Leigh et al. teaches astaxanthin used in the fish feed (0053) wherein astaxanthin is dispersed in soy bean oil (0090). Leigh teaches the method of production of fish pellet taught provides high quality feed with improved properties (0056).
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to have combined the teachings of Aksnes and Leigh and disperse astaxanthin in soybean protein because Leigh teaches dispersing astaxanthin in soybean products in fish diets was known in the art and the method of production of fish pellet taught by Leigh provides high quality feed with improved properties.
From the teaching of the references, one of ordinary skill in the art would have had a reasonable expectation of success to arrive at the claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made.
Response to Arguments
Applicants’ arguments filed on 2/13/2026 with respect to the 103 rejections have been fully considered but are not persuasive.
Applicant reiterated the argument that the minimum protein content of 18.7% protein calculated by the examiner is incorrect and that the highest possible protein content for the primary reference is 12.2%, and therefore Aksnes does not teach the amount of soy protein and the ratio of soy protein to astaxanthin recited in the amended instant claims.
In response, as discussed in the previous office action, while the examiner agrees that the 18.7% protein content calculated by the examiner was incorrect, however, the 12.2% protein content calculated by applicant is limited to the example on Table 1.B and Aksnes does not teach away from amounts of soy protein higher than 12.2%. “Disclosed examples and preferred embodiments do not constitute a teaching away from the broader disclosure or non-preferred embodiment.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). MPEP 2123. Specifically, as discussed in the modified 103 rejection above, Aksnes teaches the composition for growth in fish and the natural fish prey for carnivorous fish such as salmonoids has 10-90 wt% of protein. Protein requirements usually are lower for herbivorous fish (plant eating) and omnivorous fish (plant-animal eaters) than they are for carnivorous (flesh-eating) fish, and are higher for fish reared in high density (recirculating aquaculture) than low density (pond aquaculture) systems. Protein requirements generally are higher for smaller fish. As fish grow larger, their protein requirements usually decrease. In one embodiment the fish feed composition comprises from 40 to 80% of protein. (para 0041; 0047; 0050-52; 0101; 0154). Therefore, absence any unexpected effect, it would have been obvious to one skilled in the art to manipulate the amount of soy protein in the composition and determine and optimal amount based on the factors/parameters disclosed by Aksnes which affect the amount of protein required by the fish. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With respect to the ratio of fermented soybean protein and astaxanthin, it would have been obvious to one skilled in the art to manipulate the amount of soybean protein and the ratio of soybean protein to astaxanthin based on the protein requirement of the fish, which would depend on, for example, the size of the fish. Therefore, absence a criticality, the determination of an optimal ratio/amount of soy protein and astaxanthin would have been obvious to one skilled in the art. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Applicant argue that Aksnes does not teach administering the composition beginning at first oral feeding and continuing through the defined early development milestone recited in claims 1 and 22. Nor does Aksnes disclose imprinting fry fish or inducing resistance to soy induced inflammatory enteritis through early life exposure. Applicant argued that Sweeney is cited for aquaculture methods involving young carnivorous fish species. However, Sweeney does not disclose fermented soybean protein present at not less than 25%, fermented soybean protein having a protein content of at least 55%, the defined timing limitations recited in claims 1 and 22, or imprinting resistance to inflammatory enteritis.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed supra, It would have been obvious to follow Aksnes teaching and to feed the fry fish with the fish feed comprising ingredients, e.g., fermented soybean protein and astaxanthin, because Aksnes teaches that said fish feed is effective to prevent inflammatory condition (e.g., enteritis) in fish, and it can be provided to any fish which is susceptible to plant-induced enteritis (i.e. soybean protein induced enteritis), especially the family Salmonidae fish. Aksnes teaches the fish feed composition can be used for feeding fish at any feeding rate and by any feeding method and SWEENEY suggests a process which is useful for farming young salmon fish, wherein the fry (young) salmon fish, after it has hatched, will commence feeding for a period of suitable time until the salmon fish grow to a desirable market weight, i.e. about 8 pounds, and such suggestion provides the motivation for one ordinary skill in the art to do so. It would have been obvious to feed the fish until the fish to achieve the desirable size, i.e. about 8 pounds, because SWEENEY suggests that when the salmon crop are grown to the size such as about 8 pounds, they can be harvested, and such teaching implicitly suggested that such size is marketable. Further, a skilled person in the art would have the capability and knowledge to modify the growing and harvest period to produce a smaller or larger size salmon fish, if smaller or larger size fish is desirable. As such, Aksnes and SWEENEY’s teaching is sufficient to establish a prima facie case of obviousness.
Applicant further argued that Miyota et al. is relied upon for disclosure of additional feed ingredients such as nut meal and related components. While Miyota et al. may disclose such ingredients in feed formulations, Miyota et al. does not cure the deficiencies of Aksnes and Sweeney with respect to the claimed early developmental administration window, the quantitative fermented soybean protein limitation, or the >55% protein content requirement
In response, applicant’s arguments regarding Aksnes and Sweeny have been addressed above. Regarding Miyota, it would have been obvious to incorporate additional and useful fish feed ingredients, i.e. nut meal, into Aksnes fish feed because the reference MIYOTA teaches that nut oil meals are common and useful ingredients added into the conventional fish-farming feed for feeding fish, i.e. salmon. Such teaching provides the motivation for one ordinary skill in the art to include these useful ingredients into their fish feed composition for feeding salmon fish, if they are desirable, as suggested by MIYOTA.
Applicant argued that Yamamoto et al. is cited as teaching fermented soybean meal and improved growth performance relative to non-fermented soybean meal. Even assuming Yamamoto et al. disclose fermentation improving certain growth parameters, Yamamoto et al. do not disclose or suggest administering fermented soybean protein at not less than 25% and having at least 55% protein content beginning at first oral feeding and continuing until the fry reaches about a 50% increase in weight and/or at least 30 days of rearing. Nor does Yamamoto et al. disclose imprinting resistance to soy-induced inflammatory enteritis or achieving growth and survivability not less than a fish meal control under the claimed conditions.
In response, applicant’s arguments regarding soy protein concentration, method steps of feeding and resistance to inflammatory enteritis have been addressed above. Regarding Yamamoto, it would have been obvious to have combined the teachings of Aksnes and Yamamoto and include fermented soybean protein into Aksnes’s composition because Yamamoto teaches fermented soybean meal fed to rainbow trout was superior to non-fermented soybean meal in that fermentation improved the nutritive value of soybean meal.
Regarding Leigh, applicant argued that Leigh also does not disclose the astaxanthin to fermented soybean protein ratio and administering such composition beginning at first oral feeding and continuing through the defined early developmental milestone.
In response, applicant’s arguments regarding the amounts and ratio soybean protein and astaxanthin and the method of feeding have been addressed above. It would have been obvious to have combined the teachings of Aksnes and Leigh and disperse astaxanthin in soybean protein because Leigh teaches dispersing astaxanthin in soybean products in fish diets was known in the art and the method of production of fish pellet taught by Leigh provides high quality feed with improved properties.
NON-STATUTORY 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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7 and 22-31 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-2, 4-17, 19 and 27 of co-pending U.S. Patent Application No. 15/159,726 in view of Romarheim et al. (WO 2010/128312 A3), Leigh et al. (US 2008/0311267 A1; 2008) and Yamamoto et al. (Aquaculture, 309 (2010) 173-180).
The instant claims are drawn to a method of imprinting a fry fish with at least one fishmeal-free composition to be resistant to inflammatory enteritis induced by soy protein, the method comprising providing to a fry fish a fishmeal-free composition, for a period of time beginning when fry fish is first fed by mouth until fry fish reaches 50% increase in weight or is reared for at least 30 days, wherein said fishmeal-free composition consists of fermented soybean protein and astaxanthin at a ratio of between about 8x10^5:1 to about 80:1, a terrestrial animal by product, nut meal and gelatinized starch (claim 1, 5-7, 23, 28-30),
wherein the feed composition is provided to the fish for at least 124 days, the composition comprises at least about 500 ppm astaxanthin and at least 70 ppm (claim 2, 3, 27).
wherein the composition continually provided for 100 days to about 365 days, until the fish achieves a market pound size or combination thereof (claim 4, 26),
wherein the composition further comprises micromineral (claim 1, 22), the composition is delivered as powder, particles, crumbles or pellets (claim 24),
wherein the fermented soybean protein content of the fishmeal-free composition is at least 25% and wherein the fermented soybean protein has a protein content of at least 55% (claims 1 and 22),
Wherein the astaxanthin is dispersed in or top-dressed onto the fermented soybean protein (claim 31).
The conflicting claims are drawn to a method of adapting a salmonidae fish to be resistant to inflammatory enteritis induced by soy protein, the method comprising providing to a Salmonidae fry fish, within an effective period of time after said fish has hatched and for a sufficient number of days thereafter, an oral feed composition consisting of soy protein and an effective amount of astaxanthin in an amount of about 50 to 2500 ppm, or an antioxidant which is astaxanthin an amount of about 50 to 2500 ppm, to cause said fish to become resistant to inflammatory enteritis induced by soy protein (claim 1, 2, 12-14);
wherein the feed composition further comprises animal by-product meal, gelatinized starch, nut and macronutrient (clam 1), or
wherein the feed composition is provided to the fish for at least 100 days to 365 days after the fish begins feeding by mouth (claims 4-8), or
wherein or the feed composition is administered to the fish while the fish is a fry or immediately after the fish begins feeding by mouth (claim 27), or
wherein the soy protein is present in an amount of at least 25% wt/wt and soy protein has a protein content of at least 55% (claims 1, 15-19), and wherein the composition is provided until the fish achieves a market size weight (claim 9-11).
The amounts of soy protein and astaxanthin claimed in ‘726 overlap the ratio recited in the instant application.
The instant and conflicting claims differ in that the conflicting claims do no claim the ingredients recited in instant claim 22, the composition delivered as powder, particles, crumbles or pellets (claim 24), the soybean protein is fermented soybean protein and wherein the astaxanthin is dispersed in or top-dressed onto the fermented soybean protein. However, these deficiencies are cured by Romarheim, Leigh, and Yamamoto.
Romarheim teaches feed composition for the treatment or prevention of enterisitis in fish, wherein the composition comprises mineral content such as magnesium and phosphorus (pg. 9, 1st para) and wherein the preferred forms for fish feed include pellets (pg. 12, last para).
Yamamoto teaches influence of fermentation conditions for soybean meal in a non-fish meal diet on the growth performance and physiological condition of rainbow trout. Yamamoto teaches fermented soybean meal fed to rainbow trout was superior to non-fermented soybean meal in that fermentation improved the nutritive value of soybean meal. Yamamoto teaches the protein content of fermented soybean meal being 44%. (see: table 2, introduction, discussion).
Leigh et al. teaches astaxanthin used in the fish feed (0053) wherein astaxanthin is dispersed in soy bean oil (0090). Leigh teaches the method of production of fish pellet taught provides high quality feed with improved properties (0056).
It would have been obvious to a person of ordinary skill in the art to have combined the teachings of ‘726 application and Romarheim and include mineral content such as magnesium and phosphorus and make the fish feed in the form of pellets. One would have been motivated to do so because ‘726 already teaches including macronutrients and Romarheim also teaches feed composition for the treatment or prevention of enterisitis in fish, thus it would have been obvious to include minerals such as magnesium and phosphorus because both references are directed to treating enteritis in fish. Further, Romarheim teaches fish feed in the form pellet were known in the art and one skilled in the art would have easily envisioned making the fish feed of ‘726 in the form of pellets.
It would have been obvious to a person of ordinary skill in the art to have combined the teachings of ‘726 application and Yamamoto and include fermented soybean protein because Yamamoto teaches fermented soybean meal fed to rainbow trout was superior to non-fermented soybean meal in that fermentation improved the nutritive value of soybean meal.
It would have been obvious to a person of ordinary skill in the art to have combined the teachings of ‘726 application and Leigh and disperse astaxanthin in soybean protein because Leigh teaches dispersing astaxanthin in soybean products in fish diets was known in the art and the method of production of fish pellet taught by Leigh provides high quality feed with improved properties.
Therefore, one of ordinary skill in the art, at the time the claimed invention was made, would have readily recognized that the conflicting claims of co-pending U.S. Patent Application No. 15/159,726, and the claims in the instant application are obvious variant, and they are not patentability distinct to each other.
Response to Double Patenting Arguments
Applicants Remarks filed on 2/13/2026 have been considered. Applicant argued the rejection be held in abeyance until allowable subject matter has been identified.
In response, since applicant have not provided any substantial arguments regarding the double patenting rejection, the rejection is maintained.
Conclusion
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.
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/A.S/ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616