Patent Application 15159726 - METHOD FOR INCREASING THE UTILIZATION OF SOYBEAN

Title: METHOD FOR INCREASING THE UTILIZATION OF SOYBEAN PROTEIN BY SALMONID FISH

Application Information

Invention Title: METHOD FOR INCREASING THE UTILIZATION OF SOYBEAN PROTEIN BY SALMONID FISH
Application Number: 15159726
Submission Date: 2025-05-16T00:00:00.000Z
Effective Filing Date: 2016-05-19T00:00:00.000Z
Filing Date: 2016-05-19T00:00:00.000Z
National Class: 424
National Sub-Class: 442000
Examiner Employee Number: 95282
Art Unit: 1616
Tech Center: 1600

Rejection Summary

102 Rejections: 0
103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

US 0142248🔗

Office Action Text

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 2/5/2025 is acknowledged. Claims 1-2, 4-19 and 27 are pending in the application. Claim 1 has been amended. Accordingly, claims 1-2, 4-19 and 27 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/New Rejections/Objections
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 1-2, 4-19 and 27 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) and MIYOTA et al. (U. S. PG-Pub. No. 2005/0142248 A1).
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 (0012; 0219; 0041).
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 necessary for optimal growth and health of fish (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 teaches the amount of plant protein from soy protein concentrate (67 g), full fat soy bean meal (70 g) and extracted soy bean meal (50 g) is 187 g per kg, which equates to 18.7% of soy protein and reads on the amounts recited in the instant claims. (para 0334; Table 1.B).
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, within an effective period of time after the said fry fish has hatched and for a sufficient number of days thereafter and for a number of days (e.g., 100 to 365 days) after the fish begins feeding by mouth; wherein the composition is provided to the fish until fish achieves a market size weight (e.g., 1 to 12 pounds); and wherein the composition is administered to the fish immediately after the fish begins feeding by mouth. Aksnes also does not expressly teach wherein the composition further includes nut-meal. However, Sweeney and Miyota 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 fry salmonidae fish after it has hatched as recited in claims 1, and also implicitly suggested the fry salmonidae fish is fed after the fish begins feeding by mouth as the manner recited in claim 27 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 the recitation “feeding the salmonidae fish for at least 100 days, i.e. 120, 190, 230 and 365 days as recited in claims 4-8, because the period of “two years” would encompass the period of at least 100 days, or the period for 120, 190, 230 or 365 days as claimed.
The teaching of SWEENEY also reads on the “feeding the fish until the fish to achieve the market size”, as recited in the instant claims 9 and 10, because the harvested marketable weight “about 8 pounds” taught by SWEENEY is encompassed by the size weight of “about 1 to about 12 pounds”, and is close to the size weight of “about 6 pounds” as claimed.
With respect to the smaller market size weight, i.e. from about 1 to about 3 pounds, as recited in the instant claim 11, a skilled person in the art would have the capability and knowledge to modify the growing period and harvest condition, i.e. harvest the fish at a relatively young age or small size, depending on the particular species as suggested by SWEENEY (see: col. 12, line 9-27).
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]).

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 Salmonidae fry fish with the fish feed comprising ingredients, e.g., soy 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. With respect to the smaller market size weight, i.e. from about 1 to about 3 pounds as claimed, a skilled person in the art would have the capability and knowledge to modify the growing and harvest period to produce smaller size salmon fish, if smaller size fish is also 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.
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 2/5/2025 with respect to the 103 rejections have been fully considered but are not persuasive.
Applicant argued Aksnes does not teach use of fishmeal or fish protein free composition because Aksnes teaches a currently preferred protein source is a marine protein (para 0053) and which would indicate to the skilled artisan that Aksnes recognizes that a fish protein source is necessary. It was argued that there is no teaching or suggestion in Aksnes where complete exclusion of a fish protein in a composition is to be used.
In response, as discussed supra, 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 also discloses the protein source may be fish meal, blood meal, meat meal, bone meal, or proteins derived from a vegetable source such as soy beans (para 0053). Therefore, Aksnes stating that a currently preferred protein source is a marine protein does not teach away from using other protein sources because Aksnes clearly states that animal or plant based protein source can alternatively be used in the composition. The rejection is made under 103 and does not need to exemplify all embodiments, only suggest. “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.
Applicant argued that given the presence of anti-nutritionals in soybean protein, one skilled in the art would not predict that a composition with protein sourced from soy and animals would provide the necessary nutritional requirements. Applicant in the remarks pointed to Yu et al. to argue that as per Yu et al., composition comprising animal by product + fishmeal negatively affect the growth and feed of coho salmon.
In response, firstly the examiner cannot find any submission of the Yu et al. reference applicant refer to and the examiner respectfully requests that applicant submit the Yu et al. reference for consideration. Further, the examiner argues that Aksnes teaches the composition comprising soy protein, bone meal from animals, astaxanthin and macronutrients and applicant have not shown any evidence that a composition comprising these components would negative affect growth of fish. Moreover, per the applicant, Yu et al. teaches combination of animal by product and fishmeal negatively affecting the growth. However, as discussed supra, Aksnes does not require utilizing a combination of animal by product and fishmeal. Therefore, applicant’s arguments regarding the 103 rejections are not found persuasive at this time.

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 1-2, 4-19 and 27 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over conflicting claims 1-7 and 22-31 of co-pending U.S. Patent Application No. 16/274,869 in view of ROMARHEIM et al. (WO 2010/128312 A3).
The instant claims are drawn to a method of adapting a salmonidae fish to be resistant to inflammatory enteritis induced by soy protein, wherein the method comprises 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, a fishmeal free oral feed composition consisting of: (i) soy protein and (ii) an effective amount of an antioxidant (i.e. astaxanthin);
wherein the feed composition further comprises animal by-product meal, nut-meal, gelatinized starch and macrominerals;
wherein the feed composition is provided to the fish for at least 100 days;
wherein the astaxanthin is present in an amount from about 50 to about 2500 ppm;
wherein the soy protein is present in an amount from about 2 % to about 80 % by weight; OR
wherein the feed composition is administered to the fish while the fish is a fry or is administered to the fish immediately after the fish begins feeding by month.
The conflicting claims 1-7 and 22-31 are drawn to a method of imprinting a fry fish with at least one fishmeal-free composition, which composition effects resistance to inflammatory enteritis induced by soy protein in said fish, the method comprises providing to a fry fish a fishmeal-free composition for a period of time beginning when said fry fish is first fed by mouth until said fry fish reaches about a 50% increase in weight and/or is reared for at least 30 days, wherein said fishmeal-free composition consists of soybean protein, astaxanthin, animal by-product, nut meal and gelatinized starch (claim 1). ‘869 further claims continuing to feed said fry fish for at least 124 days (claim 2). ‘869 claims fishmeal-free composition comprises at least about 500 ppm astaxanthin (claim 3) or at least 70 ppm (claim 27). The composition is continually provided for 100 days to about 365 days until the fish achieves a market pound size or market size weight of between 1 pound to 12 pound (claim 4, 26). The composition further comprises macrominerals and the fish is salmonid fish, salmon or trout (claims 5-7, 22, 28-30).
The instant and conflicting claims differ in that the instant claims 15-19 recite the soy protein is present in an amount ranging from 2% to 80%, 10% to 60%, 20% to 50%, and 25% to 30%, whereas the conflicting claims do not recite this limitation. The deficiency is suggested by the reference Romarheim.
As discussed supra, ROMARHEIM teaches that the soybean meal can be present in an amount from 5-50 % by weight of the fish feed (see: page 14, 2nd paragraph, line 4-5).
It would have been obvious to a person of ordinary skill in the art to have combined the teachings of ‘869 application and Romarheim and include soybean in the composition of ‘869 in the amount disclosed by Romarheim. ‘869 already teaches including soybean in the composition, but is silent on the weight percent per the composition and Romarheim, which also teaches a composition comprising astaxanthin and soybean, discloses the amounts of soybean which are known to be used in the art. Thus, absence a criticality of the amount of soybean, it would have been obvious to one skilled in the art to look towards to teachings of Romarheim and include the amount of soybean as taught by Romarheim and manipulate the amounts thereof based on, for example, the size of the fish and/or an amount that would yield optimal growth of the fish.
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. 16/274,869, 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 2/5/2025 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