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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15 in the reply filed on November 5, 2025 is acknowledged. Claims 16-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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 2, 3, and 10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 2 recites the broad recitation at least 10%, and the claim also recites 15%, 20%, 25%, or 30% which are the narrower statements of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 3 recites the broad recitation less than 30%, and the claim also recites 20%, 15%, or 10% which are the narrower statements of the range/limitation. The claim is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
The term “primary protein” in claim 10 is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear as to what would and would not constitute a “primary protein” as claimed. For example, it is unclear as to if the term requires said protein to be the one in the greatest weight percent, or volume percent or some other measurment, or if said protein must contribute the greatest amount of essential nutrients to some animal, etc. The metes and bounds for what would and would not constitute a primary protein are unclear.
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.
Claims 1-3 and 6-14 are rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al (WO 2015/021352 A2) in view of Oliva-Teles et al (“Replacing fishmeal and fish oil in industrial aquafeeds for carnivorous fish” Feed and Feeding Practices in Aquaculture 2015 pages 203-224).
Regarding claims 1-3 and 7-14, Feinberg et al (Feinberg) teaches producing proteins for feed compositions from unmodified, i.e. not genetically modified, methylotrophic bacterium which are methanol fed (abstract and paragraphs 20, 30, 50, 75, 124-127, 188, 190, 216, Example 1). It is noted that in an alternative embodiment, the biomass of Feinberg may be genetically modified. Feinberg teaches that the feed provides for complete nutrition, including a source of protein comprising all essential amino acids, for aquatic species including salmonoids and carnivorous fish (paragraphs 9, 10, 30-32, 100, 135-136, 154, 162, and 184). Feinberg teaches that the feed contains at least 1% biomass and is optimized for consumption by fish (paragraphs 21, 22, and 306 and claim 14), and thus encompasses a methylotrophic single cell protein product in an amount of at least 5% as recited in claim 1, or preferably at least 10% as recited in claim 2.
Regarding the animal feed as comprising less than 20% plant based protein products as recited in claim 1, as discussed above, Fienberg teaches feed for fish. Feinberg teaches that although vegetable proteins are commonly used, they lack essential amino acids (paragraph 333). Feinberg teaches that the feed contains at least 1% biomass and is optimized for consumption by fish (paragraphs 21, 22, and 306 and claim 14). Thus, as Feinberg teaches providing essential nutrients from the biomass, wherein the plant-based proteins were recognized as lacking essential amino acids, and wherein no requirement for plant-based proteins was made or suggested, it would have been an obvious suggestion of the prior art to form the feed without plant-based protein products, thus making obvious a feed with less than 20% plant based protein products as claimed.
Regarding the animal feed as comprising less than 35% animal derived protein products as recited in claim 1, preferably less than 30% as recited in claim 3, or 1-20% fish meal as recited in claim 13, wherein the methylotrophic single cell protein is the primary protein in the feed as recited in claim 10, or is included from 20-30% as recited in claim 11, or 10-30% as recited in claim 12, as discussed above, Feinberg teaches of a fish fed, including for carnivorous fish, comprising at least 1% biomass, wherein the feed is optimized for consumption. Feinberg teaches that fish feed comprises fishmeal, fish oil, and other components such as vegetable protein (paragraphs 10, 58, 167-171) and that the method of making the inventive feed includes reducing wild fish inputs including fish oil and fish meal with the biomass product (paragraph 17). Thus, to have a fish feed comprising greater than 1% methylotrophic single cell protein, including from 20-30% or 10-30%, wherein the methylotrophic single cell protein was the primary protein and fish meal was reduced or replaced would have been an obvious suggestion of the prior art. Feinberg teaches that although vegetable proteins are commonly used, they lack essential amino acids (paragraph 333). Feinberg is not specific to the amount of fish meal within the feed.
Oliva-Teles et al (OT) teaches that fish meal (FM) is considered the most adequate protein source for fish, but that the supply is limited, and thus prices are increasing, as is the need to reduce dependency on fish meal (pages 203-205). OT teaches that replacing half of the FM with plant protein is relatively simple (page 205 last paragraph). OT teaches that estimated fish meal in aquafeeds is estimated at 22% in 2010 for salmonoids and 26% for marine fishes, with reduced levels of 12% in 2020 (Table 8.2).
Thus, as Feinberg teaches the single cell protein product replaces the fish meal and is included in an amount of at least 1%, it would have been obvious for the fish feed of Feinberg to comprise up to the known amount of fish meal, i.e. 22% or 26% as taught by OT, with the single cell protein as the primary protein in the feed, thus producing a feed comprising 26% or less fish meal which encompasses the claimed ranges. It would have been further obvious to replace half or more of the known amount of fish meal in feed as OT teaches that FM was in high demand, Feinberg teaches that the biomass product can replace the FM and/or as OT teaches that half of the FM can be easily replaced with vegetable protein which was known to not have a full nutritional value, and the biomass product did have the full nutritional value.
Regarding the essential amino acid index in the single cell protein product as at least 0.9 for Atlantic Salmon as recited in claim 6, as Feinberg teaches that the feed provides for complete nutrition, including a source of protein comprising all essential amino acids, for aquatic species including salmonoids (paragraphs 9, 10, 30-32, 100, 135-136, 154, 162, and 184); and that the feed contains at least 1% biomass and is optimized for consumption by fish (paragraphs 21, 22, and 306 and claim 14) the product is claimed is considered encompassed or alternatively obvious over the prior art. As Feinberg teaches complete nutrition to have all essential amino acids, to have an essential amino acid index in the single cell protein product as at least 0.9 for Atlantic Salmon would have been a clear and obvious suggestion of the prior art.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al (WO 2015/021352 A2) in view of Oliva-Teles et al (“Replacing fishmeal and fish oil in industrial aquafeeds for carnivorous fish” Feed and Feeding Practices in Aquaculture 2015 pages 203-224) and Schiff-Deb et al (US 2022/0119851).
Feinberg et al (Feinberg) teaches producing proteins for feed compositions from unmodified, i.e. not genetically modified, methylotrophic bacterium, i.e methylotrophs which are methanol fed, and thus not fed methane (abstract and paragraphs 20, 30, 50, 75, 124-127, 188, 190, 216, Example 1). It is noted that in an alternative embodiment, the biomass of Feinberg may be genetically modified. Feinberg teaches that the feed provides for complete nutrition, including a source of protein comprising all essential amino acids, for aquatic species including salmonoids and carnivorous fish (paragraphs 9, 10, 30-32, 100, 135-136, 154, 162, and 184). Feinberg teaches that the feed contains at least 1% biomass and is optimized for consumption by fish (paragraphs 21, 22, and 306 and claim 14), and thus encompasses a methylotrophic single cell protein product in an amount of at least 5% as recited in claim 4.
Regarding the animal feed as comprising less than 40% plant based protein products as recited in claim 4, as discussed above, Fienberg teaches feed for fish. Feinberg teaches that although vegetable proteins are commonly used, they lack essential amino acids (paragraph 333). Feinberg teaches that the feed contains at least 1% biomass and is optimized for consumption by fish (paragraphs 21, 22, and 306 and claim 14). Thus, as Feinberg teaches providing essential nutrients from the biomass, wherein the plant-based proteins were recognized as lacking essential amino acids, and wherein no requirement for plant-based proteins was made or suggested, it would have been an obvious suggestion of the prior art to form the feed without plant-based protein products, thus making obvious a feed with less than 20% plant based protein products as claimed.
Regarding the animal feed as comprising less than 40% animal derived protein products as recited in claim 4, as discussed above, Feinberg teaches of a fish fed, including for carnivorous fish, comprising at least 1% biomass, wherein the feed is optimized for consumption. Feinberg teaches that fish feed comprises fishmeal, fish oil, and other components such as vegetable protein (paragraphs 10, 58, 167-171) and that the method of making the inventive feed includes reducing wild fish inputs including fish oil and fish meal with the biomass product (paragraph 17). Thus, to have a fish feed comprising greater than 1% methylotrophic single cell protein, wherein the methylotrophic single cell protein was the primary protein and fish meal was reduced or replaced would have been an obvious suggestion of the prior art. Feinberg teaches that although vegetable proteins are commonly used, they lack essential amino acids (paragraph 333). Feinberg is not specific to the amount of fish meal within the feed.
Oliva-Teles et al (OT) teaches that fish meal (FM) is considered the most adequate protein source for fish, but that the supply is limited, and thus prices are increasing, as is the need to reduce dependency on fish meal (pages 203-205). OT teaches that replacing half of the FM with plant protein is relatively simple (page 205 last paragraph). OT teaches that estimated fish meal in aquafeeds is estimated at 22% in 2010 for salmonoids and 26% for marine fishes, with reduced levels of 12% in 2020 (Table 8.2).
Thus, as Feinberg teaches the single cell protein product replaces the fish meal and is included in an amount of at least 1%, it would have been obvious for the fish feed of Feinberg to comprise up to the known amount of fish meal, i.e. 22% or 26% as taught by OT, with the single cell protein as the primary protein in the feed, thus producing a feed comprising 26% or less fish meal which encompasses the claimed ranges. It would have been further obvious to replace half or more of the known amount of fish meal in feed as OT teaches that FM was in high demand, Feinberg teaches that the biomass product can replace the FM and/or as OT teaches that half of the FM can be easily replaced with vegetable protein which was known to not have a full nutritional value, and the biomass product did have the full nutritional value.
Regarding the methylotroph as a methylovorus methylotroph as recited in claim 4. Schiff-Deb et al (SD) teaches culturing of biomass of not genetically modified methylotrophs to produce proteins for animal feed products (abstract and paragraphs 1, 2, 12, 13, 19, 20, 22, 36, 71, and 158). SD teaches that the methylotrophs include obligate bacterium, including methylovorus sp., which were known to produce heme proteins (paragraphs 25 and 30). SD teaches that said culturing of biomass results in faster more efficient growth of cells, with enhanced efficiency for the product of interest (paragraphs 159 and 162). It would have been obvious for the methylotroph of Feinberg to be of the methylovorus species as taught by SD as Feinberg teaches that the feed is for carnivores fish, and the methylotroph protein replaces fishmeal, and as SD teaches that the methylovorus species produces heme proteins which would be in fish meal and/or eaten by carnivores.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al (WO 2015/021352 A2).
Feinberg et al (Feinberg) teaches producing proteins for feed compositions from unmodified, i.e. not genetically modified, methylotrophic bacterium which are methanol fed (abstract and paragraphs 20, 30, 50, 75, 124-127, 188, 190, 216, Example 1).
Regarding the methylotrophic single cell protein product as comprising all essential amino acids, wherein the apparent digestibility coefficient for each essential amino acid is at least 85% in Atlantic salmon, as Feinberg teaches that the feed provides for complete nutrition, including a source of protein comprising all essential amino acids, for aquatic species including salmonoids (paragraphs 9, 10, 30-32, 100, 135-136, 154, 162, and 184); and that the feed contains at least 1% biomass and is optimized for consumption by fish (paragraphs 21, 22, and 306 and claim 14) the product is claimed is considered encompassed or alternatively obvious over the prior art. As Feinberg teaches complete nutrition to have all essential amino acids, to have a high digestibility coefficient for said amino acids would have been a clear and obvious suggestion of the prior art.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Feinberg et al (WO 2015/021352 A2) in view of Oliva-Teles et al (“Replacing fishmeal and fish oil in industrial aquafeeds for carnivorous fish” Feed and Feeding Practices in Aquaculture 2015 pages 203-224), further in view of Schiff-Deb et al (US 2022/0119851).
As discussed above, Feinberg teaches producing proteins for feed compositions from unmodified methylotrophs for providing complete nutrition, including a source of protein comprising all essential amino acids, for aquatic species including salmonoids and carnivorous fish, wherein the methylotrophic protein product replaces fish meal.
Feinberg is silent to the methylotroph as a methylovorus methylotroph as recited in claim 15.
Schiff-Deb et al (SD) teaches culturing of biomass of not genetically modified methylotrophs to produce proteins for animal feed products (abstract and paragraphs 1, 2, 12, 13, 19, 20, 22, 36, 71, and 158). SD teaches that the methylotrophs include obligate bacterium, including methylovorus sp., which were known to produce heme proteins (paragraphs 25 and 30). SD teaches that said culturing of biomass results in faster more efficient growth of cells, with enhanced efficiency for the product of interest (paragraphs 159 and 162).
It would have been obvious for the methylotroph of Feinberg to be of the methylovorus species as taught by SD as Feinberg teaches that the feed is for carnivores fish, and the methylotroph protein replaces fishmeal, and as SD teaches that the methylovorus species produces heme proteins which would be in fish meal and/or eaten by carnivores.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELLY BEKKER whose telephone number is (571)272-2739. The examiner can normally be reached Monday-Friday 8am-3:30pm.
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KELLY BEKKER
Primary Patent Examiner
Art Unit 1792
/KELLY J BEKKER/Primary Patent Examiner, Art Unit 1792